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Erba XL-200 en User Manual C-dXlw4s8L1m

Erba XL-200 en User Manual C-dXlw4s8L1m
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100% found this document useful (1 vote)
194 views428 pages

Erba XL-200 en User Manual C-dXlw4s8L1m

Erba XL-200 en User Manual C-dXlw4s8L1m
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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XL-200

Fully Automated Clinical


Chemistry Analyzer

USER MANUAL
INS00001 with ISE
INS00002 without ISE

Date of last revision:


04/2023
Erba Lachema s.r.o., Karásek 2219/1d, 621 00 Brno, CZ CC/IFU/200/23/C
XL-200
Fully Automated Clinical Chemistry Analyzer

The analyzer is a random access, discrete, patient prioritized, fully


automated clinical chemistry analyzer designed to meet the needs
of modern clinical laboratories in mind for high throughput.

Once programmed, it is a walk-away system. The analyzer features


are user-friendly with minimum operator intervention. It is a highly
sophisticated system and therefore it is of utmost importance that
the operator and service personnel read the instructions and
becomes familiar with the operation theory.
Copyright
Copyright © 2022, Erba Lachema s.r.o. All rights reserved.
This manual contains material proprietary to Erba Lachema and is proteced by copyright laws.
Therefore, the manual and any of its content must not be modified, reproduced, transmitted or
translated without the written consent of Erba Lachema.

Disclaimer
While every effort has been made to ensure the accuracy and completeness of the provided
information, it cannot be guaranteed that the manual is free of errors. Therefore, Erba Lachema
shall not be held responsible and disclaims all liability for any loss or damage resulting from er-
rors or ommissions in this document.
The content and specifications of the manual are subject to change without prior notice.
Any misusage or unspecified modifications to the instrument will void the warranty and may
result in injuries. All operators are urged to carefully read and follow the safety instructions and
precautions which are intended to protect them against injuries and the instrument from damage.
The following icons are used on the instrument to aid the user:

CE Mark  evice complies with the Regulation (EU) 2017/746


D
on IVD MD

Caution Indicates the need for the user to consult the instruc-
tions for use for important cautionary information such
as warnings and precautions that cannot, for a variety
of reasons, be presented on the medical device itself.
Consult instructions Indicates the need for the user to consult the instruc-
for use tions for use.

Temperature limit Indicates the temperature limits to which the medical


device IVD can be safely exposed.

In vitro diagnostic Indicates a medical device IVD that is intended to be


medical device used as an in vitro diagnostic medical device.

Manufacturer Indicates the medical device IVD manufacturer.

Serial Number Indicates the manufacturer’s serial number so that


a specific medical device IVD can be identified.

Catalogue number Indicates the manufacturer’s catalogue number so that


the medical device IVD can be identified.

Date of manufacture Indicates the date when the medical device IVD was
manufactured.
Classified collection of The symbol on the product indicates that this
electrical and electronic product may not be treated as a household waste.
quipment Instead it shall be handled to the applicable
collection point for the recycling of electrical and
electronic equipment. By ensuring this product is
disposed of correctly, you will help prevent potential
negative consequences for the environment and
human health, which could otherwise be caused
by inappropriate waste handling of this product.
Please contact your local city office or your
distributor of this product. Pursuant to the EU
directive 2002/96/EC
• For medical devices sold from that time by Erba
Lachema the corresponding costs are divided
up as described below:
1. The concerned device delivery to Erba
Lachema will be paid by the CUSTOMER
2. Device dismantling sorting of parts and
elimination of wastes will be supported by
Erba Lachema according to the existing local
regulation
3. In case of a sale to a third-party the first
CUSTOMER shall inform Erba Lachema of
the name and address of the new owner
to guarantee the device traceability and to
allow it’s further elimination, and shall inform
of the new owner that he will pay for the
delivery of the device to Erba Lachema for
its elimination
4. Otherwise the first CUSTOMER will pay
all of the costs and all penalties that the
legal authorities should impose on the
manufacturer for default of the device
elimination traceability as requested by the
regulation
• For medical devices sold before that time,
except in particular cases, the elimination of the
device will be supported by the CUSTOMER.
Upon request Erba Lachema could provide this
elimination. Contact us for quotation
• For medical devices sold and used in other
countries, the CUSTOMER should contact
the Erba Lachema REPRESENTATIVE to be
informed of his responsibilities
Document Conventions
Before reading the manual, please get familiarized with the following icons used in this manual.

Icons Warnings

Bio-hazard

Electric shock

High temperature

Warning and caution

Note, usage, tips and additional information

Injury

Information or note related to Test Loader System


Contents 5

Table of Contents

Foreword 11

Part I System Overview 1-2


1 Intended
................................................................................................................................
use of the instrument 1-2
XL-200 w..........................................................................................................................................................
ithout ISE 1-2
XL-200 w..........................................................................................................................................................
ith ISE 1-2
2 Introduction
................................................................................................................................ 1-2
What the..........................................................................................................................................................
system does 1-3
Basic principles
.......................................................................................................................................................... 1-3
3 A first
................................................................................................................................
look at the analyzer 1-5
Analyzer.......................................................................................................................................................... 1-5
Host .......................................................................................................................................................... 1-6
4 System
................................................................................................................................
description 1-7
Panels and
..........................................................................................................................................................
labels 1-7
Front.........................................................................................................................................................
view 1-7
Right.........................................................................................................................................................
side view 1-9
Left side
.........................................................................................................................................................
view 1-9
Modules..........................................................................................................................................................
and m ain com ponents 1-10
Functional
.........................................................................................................................................................
system 1-10
Sample and .........................................................................................................................................
Reagent Pipette Unit (SRPT) 1-11
Sample Barcode .....................................................................................................................................
Reader 1-11
Auto Sampler .........................................................................................................................................
Unit (ASP) 1-12
Reagent Tray .........................................................................................................................................
(RGT) 1-14
Reagent Bar .....................................................................................................................................
Code Reader 1-14
RGT Cooling .....................................................................................................................................
Unit 1-14
Pipette Pump .........................................................................................................................................
Assembly 1-15
Mixture Stirrer .........................................................................................................................................
Unit 1-16
Cuvette Rinsing .........................................................................................................................................
Unit (CRU) 1-16
Reaction Tray .........................................................................................................................................
(RCT) 1-18
Photometer .........................................................................................................................................
Unit 1-19
Liquid Level .........................................................................................................................................
Sensing for Cans (Float Sensors) 1-20
5 Overview
................................................................................................................................
of user tasks 1-20
Daily routine
.......................................................................................................................................................... 1-20
System
.........................................................................................................................................................
Water Can and Waste Can 1-20
Cleaning
.........................................................................................................................................................
Can 1-20
Preparation
.........................................................................................................................................................
of tank solution 1-21
Cleaning..........................................................................................................................................................
the instrum ent externally 1-21

Part II System Installation 2-2


1 Safety
................................................................................................................................
Instructions 2-2
2 Storage
................................................................................................................................
and Transportation 2-3
3 Pre-installation
................................................................................................................................ 2-3
Laboratory..........................................................................................................................................................
cleanliness (practice) 2-3
Electrical..........................................................................................................................................................
requirem ents 2-4
Floor requirem
..........................................................................................................................................................
ents 2-5
Room lighting
.......................................................................................................................................................... 2-5
External interferences
.......................................................................................................................................................... 2-5
Room tem ..........................................................................................................................................................
perature and hum idity 2-5
Proper ventilation
.......................................................................................................................................................... 2-6
4 Installation
................................................................................................................................ 2-6

XL-200
6 Contents

Receiving ..........................................................................................................................................................
Inform ation 2-6
Receiving
.........................................................................................................................................................
Instructions 2-6
Warranty
.........................................................................................................................................................
Information 2-7
Unpacking ..........................................................................................................................................................
the analyzer 2-7
Accessories..........................................................................................................................................................
checklist 2-8
Installing
..........................................................................................................................................................
the com ponents of analyzer 2-11
Sample
.........................................................................................................................................................
Tray and the Reagent Tray 2-12
Installing
.........................................................................................................................................................
DI Water, Cleaning, Bio-hazardous and Waste Cans 2-13
Connecting
.........................................................................................................................................................
communication cable betw een Computer and Analyzer 2-15
Printer
.........................................................................................................................................................
Installation (DeskJet / Laser) 2-16

Part III Software Installation 3-2


1 Safety
................................................................................................................................
Instructions 3-2
2 Pre-requisites
................................................................................................................................ 3-2
System Configuration
.......................................................................................................................................................... 3-2
PC Settings
..........................................................................................................................................................
required for Window s 10 3-3
Regional..........................................................................................................................................................
and Language settings for Window s 10 3-7
Test Loader
..........................................................................................................................................................
Device 3-10
3 Software
................................................................................................................................
Installation Procedure 3-11
Installing
..........................................................................................................................................................
MultiXL 3-11
Installing
..........................................................................................................................................................
Database 3-19
Installing
.........................................................................................................................................................
Blank Database 3-19
Installing
..........................................................................................................................................................
Team View er 3-22
Upgrading..........................................................................................................................................................
MultiXL Softw are 3-24
Upgrade
.........................................................................................................................................................
Softw are 3-25
Upgrade
.........................................................................................................................................................
Database 3-26
Database ..........................................................................................................................................................
Utility Options 3-29
Database
.........................................................................................................................................................
Backup 3-29
Change
.........................................................................................................................................................
Database 3-31
Restore
.........................................................................................................................................................
Archive Database 3-35
Taking
.........................................................................................................................................................
Diagnosis Backup 3-35
Accessing..........................................................................................................................................................
MultiXL Softw are 3-36

Part IV Safety Information 4-2


1 Safety
................................................................................................................................
Symbols 4-2
2 Warning
................................................................................................................................
Labels 4-2
3 Safety
................................................................................................................................
Precautions 4-4

Part V Technical Specifications 5-2


1 General
................................................................................................................................
specification 5-2
2 Installation
................................................................................................................................
Condition 5-4
3 Sampling
................................................................................................................................
unit 5-4
4 Reagent
................................................................................................................................
unit 5-5
5 Reaction
................................................................................................................................
unit 5-6
6 Optical
................................................................................................................................
absorption measurement unit 5-7
7 Data
................................................................................................................................
processing 5-7
8 Accessories/Consumables
................................................................................................................................ 5-9
9 Computer
................................................................................................................................
Specification 5-9

Part VI User Interface 6-2


1 A first
................................................................................................................................
look at the user interface 6-2

XL-200
Contents 7

................................................................................................................................
2 Main menu layout 6-4
3 Screens
................................................................................................................................ 6-5
Patients .......................................................................................................................................................... 6-5
Sample .........................................................................................................................................................
Definition Parameters 6-6
Clear.........................................................................................................................................................
Schedule 6-9
Work .........................................................................................................................................................
List 6-10
Copy .........................................................................................................................................................
Tests 6-11
Mask .........................................................................................................................................................
Tests 6-12
Dow.........................................................................................................................................................
nload Samples from LIS 6-13
Patient Definition
.........................................................................................................................................
Parameters 6-14
CEC......................................................................................................................................................... 6-15
Schedule CEC ......................................................................................................................................... 6-16
Clear Schedule .........................................................................................................................................
CEC 6-17
Edit ......................................................................................................................................... 6-17
QC/Calibration
.......................................................................................................................................................... 6-18
Schedule
.........................................................................................................................................................
QC/Calibration 6-19
Scheduling.........................................................................................................................................
Standard 6-19
Scheduling.........................................................................................................................................
Control 6-22
Scheduling.........................................................................................................................................
Blank 6-24
Scheduling.........................................................................................................................................
Calibrator 6-27
Calibration
......................................................................................................................................................... 6-29
QC Data
......................................................................................................................................................... 6-34
Tw in.........................................................................................................................................................
Plot 6-41
QC Graph
......................................................................................................................................................... 6-43
Monitor.......................................................................................................................................................... 6-45
Sample
.........................................................................................................................................................
Tray 6-47
Sample Status .........................................................................................................................................
Indicators 6-47
Reagent
.........................................................................................................................................................
Tray 6-48
Volume Scan ......................................................................................................................................... 6-49
Reaction
.........................................................................................................................................................
Curve 6-49
Barcode
.........................................................................................................................................................
Scan 6-50
Pre-Run
.........................................................................................................................................................
Options 6-54
Run.........................................................................................................................................................
Options 6-57
Work .........................................................................................................................................................
List 6-57
Selective
.........................................................................................................................................................
Vol Scan 6-61
Add.........................................................................................................................................................
Sample and Reagent (Barcoded) 6-62
Refresh
.........................................................................................................................................................
Position 6-65
Scan .........................................................................................................................................................
Pack 6-65
Reports.......................................................................................................................................................... 6-67
Patient
.........................................................................................................................................................
Report 6-68
Result
.........................................................................................................................................................
Reprint 6-76
Test.........................................................................................................................................................
Statistics 6-78
Calibration
.........................................................................................................................................................
Trace 6-80
Calibration
.........................................................................................................................................................
Monitor 6-81
Error.........................................................................................................................................................
Log 6-83
Reaction
.........................................................................................................................................................
Curve 6-84
Other......................................................................................................................................................... 6-86
Search
......................................................................................................................................................... 6-91
Patient/Samples ......................................................................................................................................... 6-92
Patient Results ......................................................................................................................................... 6-93
Calib/Control .........................................................................................................................................
Results 6-94
Consumables ......................................................................................................................................... 6-95
Tests ......................................................................................................................................... 6-96
Tests .......................................................................................................................................................... 6-97
Test.........................................................................................................................................................
Details 6-98
Test Definition
.........................................................................................................................................
Parameters 6-100
Auto Rerun ......................................................................................................................................... 6-108
Copy Test ......................................................................................................................................... 6-109

XL-200
8 Contents

Upload and .........................................................................................................................................


Dow nload Tests 6-109
Initialize Tests
......................................................................................................................................... 6-111
Special Diluent......................................................................................................................................... 6-111
Test Specific .........................................................................................................................................
Special Diluent 6-111
Cuvette Wash ......................................................................................................................................... 6-115
Warn After ......................................................................................................................................... 6-116
Test
.........................................................................................................................................................
Volumes 6-116
Sample Volumes .........................................................................................................................................
Parameters 6-117
Reagent .........................................................................................................................................
Volume and Stirrer Speed 6-117
Copy Volume ......................................................................................................................................... 6-118
Apply Normal .........................................................................................................................................
Dilution Ratio of Sample 6-118
Reference
.........................................................................................................................................................
Ranges 6-118
Copy Reference .........................................................................................................................................
Range 6-121
View Reference .........................................................................................................................................
Range 6-121
Profiles
......................................................................................................................................................... 6-121
Calculated
.........................................................................................................................................................
Items 6-121
Utility .......................................................................................................................................................... 6-123
Reagent
.........................................................................................................................................................
Position 6-123
Transfer
.........................................................................................................................................................
To Tube 6-125
Backup
......................................................................................................................................................... 6-127
Backup Operations
......................................................................................................................................... 6-129
Copy Data .........................................................................................................................................
to External Storage Device 6-130
System Backup .........................................................................................................................................
Restore 6-131
Offline
.........................................................................................................................................................
Results 6-132
Recalculate
......................................................................................................................................................... 6-133
Maintenance
.......................................................................................................................................................... 6-135
Maintenance
......................................................................................................................................................... 6-136
Span (Auto .........................................................................................................................................
and Manual) 6-136
Wash ......................................................................................................................................... 6-137
Dead Volume .........................................................................................................................................
Calibration 6-141
Auto Maintenance
......................................................................................................................................... 6-143
Cell.........................................................................................................................................................
Blank 6-145
Maintenance
.........................................................................................................................................................
Log 6-148
Archive
......................................................................................................................................................... 6-149
Archiving.........................................................................................................................................
Data 6-150
View ing .........................................................................................................................................
Archived Data 6-151
Observations ......................................................................................................................................... 6-152
Service.......................................................................................................................................................... 6-153
Master.......................................................................................................................................................... 6-162
Consumables
......................................................................................................................................................... 6-162
Area
......................................................................................................................................................... 6-178
Doctor
......................................................................................................................................................... 6-178
Analyst
......................................................................................................................................................... 6-179
Laboratory
......................................................................................................................................................... 6-180
Mfg......................................................................................................................................................... 6-181
Reference
.........................................................................................................................................................
Range 6-182
Unit
......................................................................................................................................................... 6-183
Unit
.........................................................................................................................................................
Conversion 6-184
Calculation
.........................................................................................................................................................
Formula 6-188
Instrument
......................................................................................................................................................... 6-188
Settings.......................................................................................................................................................... 6-190
System
.........................................................................................................................................................
Parameters 6-190
Carryover
.........................................................................................................................................................
Pairs 6-195
Test
.........................................................................................................................................................
Sequence 6-197
Test Display .........................................................................................................................................
Sequence 6-198
Test Process .........................................................................................................................................
Sequence 6-199
Print Sequence .........................................................................................................................................
For Patient Reports 6-200
Profile Sequence
.........................................................................................................................................
For Patient Reports 6-201

XL-200
Contents 9

.........................................................................................................................................................
Re-run Flags 6-202
User
.........................................................................................................................................................
Rights 6-202
Reflex
.........................................................................................................................................................
Test 6-203
Host
.........................................................................................................................................................
Settings 6-204
Send Patient .........................................................................................................................................
Results to Host 6-206
Send Control .........................................................................................................................................
Results to Host 6-206
Schedule.........................................................................................................................................
Test Again 6-206
Send Sample .........................................................................................................................................
Position 6-206
Query Sample .........................................................................................................................................
at a time 6-206
Checksum ......................................................................................................................................... 6-206
Send Limit .........................................................................................................................................
Values for flagged Results 6-207
Calibration
.........................................................................................................................................................
Policy 6-207
Calibration .........................................................................................................................................
Policy for Closed Channel Tests 6-208
Calibration .........................................................................................................................................
Setting -Closed Channel Reagents 6-209
Hibernate/Wake-up
.......................................................................................................................................................... 6-211
Hibernate
......................................................................................................................................................... 6-211
Wake-up
......................................................................................................................................................... 6-212
Shut Dow
..........................................................................................................................................................
n 6-212
Shut
.........................................................................................................................................................
Dow n 6-213
Water
.........................................................................................................................................................
Save and Shut Dow n 6-213
Maintenance
.........................................................................................................................................................
and Shut Dow n 6-213
Master..........................................................................................................................................................
Calibration 6-213

Part VII Operation 7-2


1 Sequence
................................................................................................................................
of operation 7-2
2 Measurement
................................................................................................................................
operation table 7-2
3 Daily
................................................................................................................................
start-up 7-4
Verifying..........................................................................................................................................................
system resources 7-4
Starting up
..........................................................................................................................................................
and logging on to the system 7-5
Defining ..........................................................................................................................................................
required consum ables 7-6
Preparing ..........................................................................................................................................................
Sam ples and Reagents 7-6
Defining ..........................................................................................................................................................
sam ples and reagents 7-9
Defining
.........................................................................................................................................................
Samples 7-9
Barcoded ......................................................................................................................................... 7-9
Non-Barcoded ......................................................................................................................................... 7-10
Defining
.........................................................................................................................................................
Reagents 7-11
Barcoded ......................................................................................................................................... 7-18
Non-Barcoded ......................................................................................................................................... 7-19
4 Daily
................................................................................................................................
routine 7-22
Starting..........................................................................................................................................................
analysis 7-22
Interruption
..........................................................................................................................................................
and resum ption of m easurem ent 7-24
User activities
..........................................................................................................................................................
during run 7-24
Self activities
..........................................................................................................................................................
during run 7-25
5 End
................................................................................................................................
of day task 7-27

Part VIII Error Handling 8-2


1 List................................................................................................................................
of Errors 8-2

Part IX Configuration 9-2


1 Login
................................................................................................................................
and password recovery 9-2
2 Setting
................................................................................................................................
UI language 9-3
3 Setting
................................................................................................................................
test sequence 9-3
4 Access
................................................................................................................................
control 9-4
To create..........................................................................................................................................................
new user login 9-4

XL-200
10 Contents

..........................................................................................................................................................
To provide access rights to existing user 9-5
To change
..........................................................................................................................................................
the user ID passw ord 9-7
5 Connection
................................................................................................................................
to Host PC 9-7
In peer to
..........................................................................................................................................................
peer netw ork 9-8
In LAN (Local
..........................................................................................................................................................
Area Netw ork) 9-9
6 Entering
................................................................................................................................
the master details 9-9
Add area
.......................................................................................................................................................... 9-10
Add doctor
.......................................................................................................................................................... 9-11
Add analyst
.......................................................................................................................................................... 9-11
Add laboratory
.......................................................................................................................................................... 9-12
Add m anufacturer
.......................................................................................................................................................... 9-13
Add reference
..........................................................................................................................................................
range 9-14
Add unit.......................................................................................................................................................... 9-14
Add calculation
..........................................................................................................................................................
form ula 9-15
Add instrum
..........................................................................................................................................................
ent 9-16
7 Archive
................................................................................................................................
Data 9-16
8 Create
................................................................................................................................
profile 9-18
Add profile
.......................................................................................................................................................... 9-18
Delete profile
.......................................................................................................................................................... 9-18

Part X Result Flags 10-2


1 Flag
................................................................................................................................
List 10-2

Part XI Maintenance 11-2


1 Daily
................................................................................................................................
Maintenance 11-2
2 Weekly
................................................................................................................................
Maintenance 11-3
3 Quarterly
................................................................................................................................
Maintenance 11-4
4 Annual
................................................................................................................................
Maintenance 11-5
5 Replacement
................................................................................................................................
Schedule for Spares and Consumable 11-6
6 Preventative
................................................................................................................................
Maintenance 11-6
Inform ation
..........................................................................................................................................................
Requested by Our Custom er Service Departm ent 11-7
Malfunction
..........................................................................................................................................................
at the Tim e of Operation 11-7
Anom alous
..........................................................................................................................................................
Measurem ent Results 11-8
Check for
..........................................................................................................................................................
Preparation of Reagent, Calibrator or QC Sam ple 11-8
High Resultant
..........................................................................................................................................................
Values from a Specific Method for all Sam ples 11-9
Low Resultant
..........................................................................................................................................................
Values from a Specific Method for all Sam ples 11-9
Random..........................................................................................................................................................
ly Derived Erroneous Measurem ent Results 11-10
Anom alous
..........................................................................................................................................................
Resultant Values from all Methods for a Sam ple 11-10

XL-200
Preface 11

Foreword
This manual is organized in a progressive sequence for easy study and reference. It is an
instructional aide to provide a reference for easy operation and general maintenance of this
analyzer. It contains detailed description of the analyzer features and specifications. The analyzer
is used with operational PC and Printer, and can interact with the host computer. The operational
PC consists of the application software for the user to operate the analyzer.

All the samples and reagents for measurements including samples obtained from patients are
controlled by barcodes enabling the analyzer to perform the entire process of the analysis
automatically.

Use of the analyzer with proper knowledge will ensure quality test results and trouble free analyzer
operation and performance.

This operation manual is prepared based on the assumption that the user has knowledge of clinical
chemistry.

Before operating the analyzer, user should:

1. Read and understand this manual.

2. Be trained by authorized person.

3. Be familiar with the operation of the analyzer

Keep this manual in an easily accessible place.

XL-200
Part

I
System Overview 1-2

1 System Overview
This section provides an overview of the analyzer and its main features.

See the following section for more details:

Intended use of the instrument

Introduction

A first look at the analyzer

System description

Overview of the user tasks

1.1 Intended use of the instrument

1.1.1 XL-200 without ISE


Automatic analyzer intended for in vitro photometric quantification of clinical chemistry parameters in
serum, plasma and urine with capacity 200 tests per hour.

The results for tested clinical chemistry parameters can be used for screening, monitoring, and
diagnosis. The function is specifically dependent on each parameter and is described in IFU of every
reagent kit provided by ERBA. For professional use in clinical laboratory only.

1.1.2 XL-200 with ISE


Automatic analyzer with additional ISE module intended for in vitro photometric quantification of
clinical chemistry parameters and ion-selective quantification of specific electrolytes (such as Na+, K
+, Li+, Cl-) in serum, plasma and urine with capacity 400/500 tests per hour.
The results for tested clinical chemistry parameters can be used for screening, monitoring, and
diagnosis. The function is specifically dependent on each parameter and is described in IFU of every
reagent kit provided by ERBA. For professional use in clinical laboratory only.

For more details on how to use XL-200 with ISE, refer “User Manual for ISE”.

1.2 Introduction
It is an advanced integrated system for diagnostic clinical chemistry testing.
It is a random access, discrete, patient prioritized, fully automated clinical chemistry analyzer
designed to meet the needs of modern clinical laboratories in mind for high throughput. Once
programmed, it is a walk-away system.
This analyzer is In -Vitro Diagnostics (IVD) equipment intended to use in pathological laboratories
and hospitals.

Random sample access, innovative robotics, and an advanced user interface, using windows
embedded operating system, optimize time management and streamline work flow.

XL-200
1-3 System Overview

Barcode identification system is provided for both, reagents and samples.

The high performance, flexibility, and versatility of the analyzer make this system suitable as a
routine analyzer as well as a dedicated instrument for specific tasks.

It is a highly sophisticated system and therefore it is of utmost importance that the operator and
service personnel read the instructions and becomes familiar with the operation theory.

1 PC

2 Analyzer

1.2.1 What the system does


The system consists of the analyzer and the data station.
The analyzer runs tests on samples, calibrators, and controls, and produces the results. The data
station analyzes and further processes the results.
Here are just some of the actions the system performs automatically.
Reads the bar-codes on reagent bottles, samples tubes and displays the related information on

the screen.

Performs washing and cleaning cycles to minimize carry-over between tests.

Calculates and ensures the integrity of the result, generating flags for suspect ones.

Keeps track of all samples, tests, and test’s schedule on the instrument.

Collates results into reports for printing or result transmission to another computer system.

Stores the results of each patient and test in a database.

Perform auto-rerun of samples.

Automatic daily maintenance.

1.2.2 Basic principles


The analyzer is an automated clinical biochemistry analyzer based on the principle of photometry, it
measures light transmittance at various wavelengths White light as we see it is actually composed of

XL-200
System Overview 1-4

several colors. This becomes evident, when we pass a beam of white light through a prism. If the light
emerging from the prism on the opposite side were allowed to fall on a screen, we would see a wide
spectrum of colors, beginning with red on the top and ending with violet at the bottom. The colors
visible in between are in the order of indigo, blue, green, yellow, and orange.

Incident or white light contains the entire spectrum, objects that appear colored, absorb light at a
particular wavelength and reflect others, thus giving different colors. That color is a function of its
wavelength.

Light having a wavelength of less than 400 nm is termed Ultraviolet, where as light having a
wavelength greater than 800 nm is described as Infrared, both ultraviolet and infrared lights are
invisible to the human eyes. Light corresponding to wavelengths between 400 nm and 800 nm is
visible to the human eye and is termed as Visible light.

Principles of Absorption Photometry

Beer’s Law
If light is allowed to pass through a colored solution, the solution will absorb some light while the rest
of it will be transmitted. The amount of light absorbed is proportional to the nature, concentration and
color of the solution. (Light absorbed Concentration of the solution).

Lambert’s Law
The light absorbed by the colored solution is directly proportional to the light path of the color solution
(diameter of the cuvette): that is if the cuvette diameter is doubled, the light absorbed will be doubled.

Since the total incident light = light absorbed + light transmitted, it follows that:

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1-5 System Overview

Therefore as the absorbed light (Absorbance) increases, the transmitted light will decrease.
As we increase the concentration of the colored solution, the light absorbed increases, and we find
that the transmittance varies inversely and logarithmically with concentration.

1.3 A first look at the analyzer


See the following section for more details:

Analyzer

Host

1.3.1 Analyzer
The analyzer features user-friendly operation with minimum operator intervention.

The analyzer comprises of photometer and sophisticated robotics combined with an Operating
Console and Data Processing Unit (DPU). The DPU in the analyzer provides a schedule to the
analyzer, after executing the schedule as per the programmed sequence, the photometric results are
then sent to the analyzer’s computer connected to the analyzer where they are processed, stored
and then reported.

The robotics consists of Sample and Reagent arm (SRPT), Stirrer unit, Cuvette Rinsing Unit, Sample
tray, Reagent tray and Reaction tray.

Bar-code identification system is provided for both, reagents and samples.

The instrument carries out all tests automatically and is equipped with measuring modules for
absorbance photometry (Abs.) and ion-selective electrode measurements (ISE).

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System Overview 1-6

Access panels to work on the internal and external parts of the analyzer.

1 PC
To schedule run,view result

2 Left Side Panel


Power supply cable and Main or Primary switch (On/Off) [Not shown].

3 Right Panel
Provides access to connectors of Waste Can, DI water Can, Cleaning Solution Can, Bio-
hazard Can, Float sensors.[Not shown]
Secondary ON/OFF switch [Not shown]

4 Status indicator
Indicates analyzer's ON/OFF status. Light turns to red when secondary switch is OFF, else
display as blue

5 Front Panel
Dome cover (open upward) gives access to load samples and reagents.

6 Test Loader Device


To scan System pack reagent k it / Special Cards

1.3.2 Host
A host is a computer connected to the analyzer PC.

The clinical laboratory instruments under consideration are those that measure one or more
parameters from one or more patient samples. Often they will be automated instruments that
measure many parameters from many patient samples. This instrument output may include patient
results, quality control results, and other related information.

The computer systems considered here are those that are configured to accept instrument results for
further processing, storage, reporting, or manipulation.

ASTM HOST protocol enables any two such systems to establish a logical link for communicating
text to send result, request, or demographic information in a standard and interpretable form.

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1-7 System Overview

Typically, Host software communicating with Clinical Laboratory Instruments is considered here as
Analyzer PC and the computer system considered here is as Laboratory Information Management
System (LIMS/LIS PC).

MultiXL communicates with LIS through Serial Port or TCP/IP. Separate serial port is required to
enable the communication with LIS through serial cable. To enable communication through TCP/IP,
the analyzer PC should be connected to local network.

1.4 System description


This section gives an overview of the hardware and provides more detailed information about the main
functional systems.

See the following section for more details:

Panels and labels

Modules and main components

1.4.1 Panels and labels


See the following section for more details:

Front view

Right side view

Left side view

1.4.1.1 Front view

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System Overview 1-8

Access panels to work on the internal and external parts of the analyzer.

1 PC
To schedule run,to view result.

2 Cover (Dome)
Provide access to sample tray and reagent tray.

3 Status Indicator
Indicates the analyzer's current state.

4 Test Loader Device


To scan System pack reagent k it / Special cards

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1-9 System Overview

1.4.1.2 Right side view

Access panels to work on the internal and external parts of the analyzer.

1 Secondary ON/OFF Switch


Secondary switch for shutting down the analyzer. except ISE module.

2 Connectors
Connector for Waste Can, Bio-hazard waste Can, Cleaning solution and DI water Can with
float switch sensors

1.4.1.3 Left side view

Access panels to work on the internal and external parts of the analyzer.

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System Overview 1-10

1 Primary ON/OFF Switch


Secondary switch for shutting down the analyzer including ISE module.

2 Stand for PC

1.4.2 Modules and main components


Following figure shows how the modules and components are arranged in the instrument.

Modules and main components

1 PC

2 Auto Sampler Unit (ASP)

3 Stirrer

4 Sample and Reagent Pipette Unit (SRPT)

5 Cuvette Rinsing Unit (CRU)

6 Reaction Cuvette Tray (RCT)

7 Reagent Tray (RGT)

8 Status monitor

9 Test Loader Device

1.4.2.1 Functional system


See the following section for more details:

Sample and reagent pipette unit

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1-11 System Overview

Sample tray

Reagent tray

Pipette pump assembly

Mixture or stirrer unit

Cuvette rinsing unit

Reaction tray

Photometer unit

Liquid level sensing for cans

1.4.2.1.1 Sample and Reagent Pipette Unit (SRPT)

The Sample & Reagent Pipette Unit (SRPT) consists of a probe (nozzle), up-and-down movement
mechanism, rotating mechanism, liquid level sensor and nozzle down limit sensor.

The SRPT is connected to the syringe pump for sample aspiration via PTFE tube. The sample or
reagent on the ASP unit or RGT tray is aspirated by the pipette and then dispensed into the cuvettes
(reaction cells) in the RCT unit. Probe has smooth finish surface from outside is passivated and
polished from inside to minimize any sample carry over. When an optional ISE unit is fitted and the
ISE measurement is performed, the SRPT aspirates sample for ISE measurement and dispenses it
into the sample port of the ISE unit.

Liquid Level Sensor (LLS)


When the tip of the nozzle reaches and touches the sample surface, the electrostatic capacitance of
the metallic nozzle varies. The variation of the capacitance is detected and consequently the level of
sample is detected.

Probe Down Limit Sensor


When the tip of probe hits the bottom during any of the downwards movement due to the obstruction,
the lower limit sensor detects that the tip of probe hits the bottom and stops its downward movement
(Vertical obstruction detection or VOD).

SRPT Washing Station


The wash station for the sample & reagent probe consists of a two position used as Drain
Position” (for internal cleaning of the probe) and as “Trough Position” (for external cleaning of the
probe). After the sample & reagent probe has dispensed sample & reagent 1 or reagent 2 into the
cuvette, the arm moves to the drain station where the chase volume is dispensed & then moves to
trough position where it is cleaned internally as well as externally using a jet of DI Water at approx.

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System Overview 1-12

40º C & 0.8 -1.2 bar pressure.

1.4.2.1.1.1 Sample Barcode Reader

The barcode reader reads barcode of the label affixed on the outer surface of the sample tube. When
the reader does not read the barcode even if the bar code label exists, the appropriate error message
is indicated.

The readable bar codes are as follows:

Symbol Valid character and symbol


NW-7 Numerals (0 – 9), symbols (-, $, /, +)
Code39 Numerals (0 – 9), alphabetical characters, symbols (-, space, $, /, +, %)
ITF Numerals only (0 – 9)
UPC Numerals only (0 – 9)
Code128: All ASCII code characters [numerals (0 – 9), alphabetical characters
Set A, Set B, Set C (uppercase/lowercase), symbols, control characters]

Resolution of the barcode label should be 0.25 mm. Length of the barcode should be 42 mm and
width should be 10 mm.

Number of digits should be between 3 to 18 but the combination of digit and type should be within the
specified length of the barcode label.

1.4.2.1.2 Auto Sampler Unit (ASP)

The auto sampler unit (ASP) consists of a removable turntable with sample tube adaptor and rotating
mechanism with a bar code reader for identifying samples.

The ASP tray can accommodates:

30 barcoded sample tubes of 5, 7, and 10 ml

9 non-barcoded cups of 2 ml

The types of usable sample tubes are shown below:

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1-13 System Overview

The sample is aspirated by the Sample & Reagent Pipette Unit (SRPT) and dispensed into cuvettes
of the Reaction Tray Unit (RCT).

The ASP tray of the analyzer consists of three rows:

Outer

Middle

Inner

The outer and middle row has total 30 positions that are used for placing Patient’s or Emergency
samples. Sample tubes as well as 2 ml cups could be placed in these two rows.

The inner row has 9 positions for placing Blank, Control, Standards and Calibrators. Patients and
Emergency samples can also be placed in these locations in 2 ml cups, if required. Only 2 ml
Sample cups or 500 µl STD cups can be placed in the positions marked as I1 to I9.

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System Overview 1-14

1.4.2.1.3 Reagent Tray (RGT)

The Reagent Unit (RGT) consists of reagent bottle tray, barcode reader, cooler, sensor and rotating
mechanism.

The reagent tray of the RGT can accommodate 50 Reagent bottles with big and small type of
containers.

The reagent tray rotates and the required reagent bottle is moved to the position where the reagent is
aspirated. At this position, the reagent is aspirated by the SRPT unit and then dispensed into
cuvettes in the RCT unit.

Type of Reagent Bottles

The reagent bottles are available in two types. The type of usable reagent bottles are shown below:

Big, (50 ml)

Small (20 ml for outer bottles).

The reagent bottles provided with the analyzer is shown below.

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1-15 System Overview

All bottles are screw capped to prevent evaporation of reagents while not in use. Total 50 bottles can
be placed (25 numbers of 50 ml and 25 numbers of 20 ml). Bar-code reader reads the bar-coded
labels on the reagent containers for identification.

1.4.2.1.3.1 Reagent Bar Code Reader

The barcode reader reads barcode of the label affixed on the outer surface of the reagent bottle. The
barcode reader used is Laser type reader. Resolution of the barcode label should be 0.25 mm. The
readable bar codes are as follows:

Symbol Valid character and symbol


ITF Numerals only (0 – 9)

1.4.2.1.3.2 RGT Cooling Unit

Even if the analyzer is turned off (by analyzer’s ON/OFF switch located on the right side of the
analyzer), the temperature inside the RGT unit is kept within the specified limits by the Peltier
element which is controlled by temperature controller.

1.4.2.1.4 Pipette Pump Assembly

There is one syringe pump of 500 µl capacity, common for both reagents as well as sample. The
syringe pump of the analyzer is a modular type by which it aspirates & dispenses volumes between
2 µl to 300 µl. Sample volumes can be increased in steps of 0.1µl. The syringe is located behind the
front plate of the analyzer and is connected to the probe via appropriate tubing.

The analyzer may have any one of the syringe type as shown below:

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System Overview 1-16

1.4.2.1.5 Mixture Stirrer Unit

The mixing stirrer unit (STIRRER) consists of the up-and-down mechanism and the paddle rotating
mechanism.

The sample and the primary reagent dispensed into the cuvettes are stirred by rotating the paddle at
predefined requested speed of high, low or medium. The paddle is washed in the STIRRER trough
with system water at 37 º C – 41 º C and pressure of 0.8-1.2 bar.

The secondary reagent dispensed into the cuvettes is stirred by rotating the paddle at predefined
speed of high, low or medium. The paddle is again washed in the STIRRER trough with system water
at 37 º C – 41 º C and pressure of 0.8-1.2 bar.

1.4.2.1.6 Cuvette Rinsing Unit (CRU)

The Cuvette Rinsing Unit (CRU) serves the purpose of washing the inner surface of the cuvettes in
which the measurement of specimen have been completed and allow them to be reused. The CRU
consists of 8 probes, probes 1 to 6 are in pairs (one for dispensing and the other one for aspirating),
followed by a single probe for final aspiration and the last probe attached with a drier serves the
purpose of drying the cuvettes.

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1-17 System Overview

The cuvette washing via the CRU takes place in 8 stages as described below:

Probe 1 – Aspirates the bio hazardous waste and dispenses cleaning solution.

Probe 2 to 6 – Aspirates the cuvette contents, and dispenses DI water.

Probe 7 – Aspirates the cuvette content.

Probe 8 – Dries the reaction cuvette.

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System Overview 1-18

1.4.2.1.7 Reaction Tray (RCT)

The reaction tray (RCT) consists of the cuvette ring set and rotating mechanism. RCT is provided with
45 hard glass cuvettes (5mm * 5mm) on its outer circumference and the temperature inside is
maintained at 37ºC (+/- 0.2ºC) constantly. The cuvettes are moved at 10-second step and a series of
process including dispensation, stirring, photometric measurement and washing will be performed.

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1-19 System Overview

To improve the efficiency of the photometer, the RCT tray will automatically
come to offset position (such that the beam falls in between two consecutive
cuvettes) on the following conditions:

After the end of batch run

When the batch run is manually terminated from Status Monitor by user

When the batch run terminated due to occurrence of any emergency error.

1.4.2.1.8 Photometer Unit

The photometer unit consists of the optical measurement system having narrow bandwidth,
wavelength specific filters with light source. The absorbance inside the cuvette is measured by using
a photometer.

Measurement is performed with any combinations of 2 wavelengths selected among the following 8
wavelengths:

340 nm, 405 nm, 505 nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm

The photometer consists of an illuminant (halogen lamp), lenses, optical filter and photoreceptor
(photodiode). The light passing through the cuvette (reaction mixture) is splitted by beam splitter,
which in turn passes through wavelength specific filter on to diode. This eliminates several optical
interferences and greatly improves the efficiency of the photometer.

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System Overview 1-20

1.4.2.1.9 Liquid Level Sensing for Cans (Float Sensors)

The Liquid Level Sensor are placed inside the respective Cans of DI water, Cleaning solution, Bio-
hazardous waste & normal waste Can. Accordingly, for DI water & cleaning solution, the float based
level sensors will sense the low level of DI water or cleaning solution & respective LED will lit on the
instrument with the beep sound.

Similarly, full levels are detected for both the waste can & respective LEDs are lit accordingly with
beep sound. All the LEDS are placed just near to the tube connection for the same cans.

1.5 Overview of user tasks


This section tells you the necessary daily routine tasks to be performed before starting the
instrument for analysis.

See the following section for more details:

Daily routine

Cleaning the instrument externally

1.5.1 Daily routine


Routine tasks as follows:

System Water Can and Waste Can

Cleaning Can

Preparation of tank solution

1.5.1.1 System Water Can and Waste Can


Make sure that:

1. The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.

2. The Bio-waste Can must be emptied.

1.5.1.2 Cleaning Can

The cleaning solution Can is filled with wash solution.

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1-21 System Overview

1.5.1.3 Preparation of tank solution


The external tanks of the system DI water, detergent, bio-hazardous waste, and diluted waste are to
be placed near the right-hand side or rear side of the analyzer and to be connected to the analyzer
with the corresponding tubes which includes float sensors.

Just before measurement, the external tanks of the system DI water and cleaning solution are filled
with the corresponding liquid, and the tanks of the bio-hazardous waste and diluted waste have to be
empty.

DI Water

Detergent solution

Bio-hazard

Diluted Waste

The DI water should have a resistivity of more than 1 Mega Ohm-cm (or conductivity less than 1µS/
cm). Also the pH of the DI Water should be maintained to 5.0 to 7.0.

Preparation of Detergent Solution

1. Fill the detergent solution can (given with the Accessories List) with 10 liter of DI water.

2. Pour the 100 ml concentrated solution into the can to prepare a 1% detergent solution.

3. Mix it well before use.

1.5.2 Cleaning the instrument externally


You can clean the instrument externally with a cloth and a soap solution with mild disinfectant, or a
solution of 70% ethanol.

Incorrect cleaning materials can damage the analyzer

Do not clean the instrument while it is switched on.


Do not use organic cleaning solvents (for example, petroleum, benzene, petrol or other
solvents) because they can damage cuvettes, tubing, and other plastic materials.
Do not use an alcohol solution with a concentration of greater than 70% alcohol, because this
may damage transparent viewing windows.
Do not use sodium hypochlorite solution because it causes corrosion on metal parts.

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Part

II
2-2 System Installation

2 System Installation
This section gives you the detailed explanation on installing analyzer.

See the following section for more details:

Pre-installation

Installation

Read the necessary general safety guidelines before installing the analyzer for the first
time. See Safety Instructions for more details.

2.1 Safety Instructions


Read the necessary general safety guidelines before installing the analyzer for the first
time.

Electrical safety:

The access to the conductive parts within the analyzer may cause serious
electric shock. When removing parts, make sure to shut off the main power
supply from the socket. Leave any maintenance and repair of electrical parts
inside the equipment to qualified service personnel.

General safety:

Only authorized service personnel should perform the installation process.

Keep the analyzer out of the rain and any other water splash.

Avoid areas that are adversely affected by atmospheric pressure, temperature,


humidity, ventilation, sunlight, dust, air containing salt or sulfur, etc.

Use level indicator for ensuring the machine is leveled properly.

Pay attention to inclination, vibration, shock (including shock during


transportation), etc.

Danger of explosion through sparks. Do not install the analyzer at the place
adjacent to the storage room of chemicals, or explosive material or the place
where any gas is likely to be generated.

Pay attention to frequency, voltage and permissible current (or power


consumption).

Connect the analyzer to the operational computer using accompanying USB


cable supplied with the analyzer. When other cable is used, this may cause the
analyzer to suffer from disturbing noise, exert an adverse effect on its
surroundings or get incorrect measurement results.

Check the power supply frequency, voltage and current capacity (power
consumption).

Ensure that the analyzer is correctly and well grounded.

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System Installation 2-3

Ensure that all the necessary electrical cables are correctly connected.

Check that the contact conditions of switches and indicators are appropriate and
that the analyzer is ready to be activated correctly. Extreme care must be taken
not to result in misdiagnosis or pose any danger to the analyzer or human body
when the analyzer in conjunction with other equipment.

2.2 Storage and Transportation


Instructions for storage, transport and handling the analyzer:

1. Analyzer is a precision instrument and must be handled by trained personnel only to avoid
damage. Improper handling may cause improper functionality.
2. It is fully inspected and carefully packed before leaving the factory to withstand shocks in transit.
3. The Manufacturer transports the instrument in it's original packing to reach arrive safely.
4. Do not let the instrument or packaging become wet or be exposed to a damp environment.

It is recommended to maintain the below mentioned environment during transportation and storage of
the analyzer.

Storage Temperature 5°C to 45°C

Storage Humidity < 80% (Non condensing)

2.3 Pre-installation
The proper location is an important consideration; a poor location can lead to malfunction of the
analyzer. To ensure the accuracy and precision of the analyzer, you must follow the pre-installation
requirements before installing the analyzer.

Read the environmental and electrical suggestions to ensure the accuracy and precision of the
analyzer.

See the following sections for more details:

Laboratory cleanliness (practice)

Electrical requirements

Floor requirements

Room lighting

External interferences

Room temperature and humidity

Proper ventilation

2.3.1 Laboratory cleanliness (practice)


The instrument and the surrounding area should be maintained clean and regularly decontaminated
to prevent contaminating yourself and others.
There should be no spillage of Serum, Reagents, Waste or DI water.

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2-4 System Installation

Make sure that no Reagents or Samples are placed on top of the analyzer or trolley as they could
spill causing a permanent damage to the analyzer.

2.3.2 Electrical requirements

A proper grounding is highly essential for safety and proper functioning of the
analyzer.

A proper grounding is highly essential for safety and proper functioning of the
analyzer.
Improper grounding the analyzer by passes important safety features and may
result in an electrical hazard.
Improper grounding to analyzer bypasses the important safety features and may
result in permanent damage to the analyzer that may void the warranty. It is
absolutely necessary to ensure proper grounding.

Voltage and frequency

Single-phase continuous stabilized AC 220 volts ± 10%, 50/60Hz or AC 110 volts ± 10%, 50/60Hz
supply.
The analyzer comes equipped with a three-pin power cord. The type of cord and plug depends on
the source voltage for the system

Grounding

It is absolutely necessary that the perfect grounding must be provided to the power source with all
applicable local requirement (only a certified grounded 3 pin power plug should be used).

Recommended earthing voltage between neutral and earth terminal is below


+3V.

Plug points

Four 5 ampere sockets must be available near the analyzer. (Four sockets are required, one each
for the analyzer, computer, monitor and printer).

It is recommended that two extra sockets be provided near the analyzer, for use by a measuring
equipment or engineering tool if required while servicing (Example Oscilloscope, Soldering iron
etc.).

Heavy-duty electrical devices like Air conditioners, refrigerators, ovens etc. should not be operated
on the same electrical lines as the analyzer

The 3 pin power cord plugs shipped with the analyzer, computer, printer and
monitor may not be compatible with the local electrical sockets of some
countries, you have to get these procured from the local market prior to the
installation.

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System Installation 2-5

2.3.3 Floor requirements

2.3.4 Room lighting


There should be sufficient room lighting, the lighting should be even, and there should be no shadow
areas, this problem can be eliminated by the use of multiple light sources from diagonally opposite
directions.

This will enable efficient operator use, and will give a clear visible access to the internal components
of the analyzer during operation and technical servicing.

2.3.5 External interferences


Heavy-duty electrical devices like air conditioners, refrigerators, ovens, centrifuges etc should
not be operated on the same electrical lines or in the close vicinity of the analyzer.

The room should be free of vibrations from heavy duty devices like centrifuges and
compressors.

The room should be free from strong magnetic fields caused by other medical equipment, like
CT Scans, MRI etc.

Mobile phones should not be operated close to the Analyzer

Verify and ensure a dust free environment for analyzer, this is a small but very important
consideration when installing the analyzer.

2.3.6 Room temperature and humidity


Measure the room temperature at different corners of the Laboratory. The recommended temperature
is 22 to 28°C with 40 to 80% humidity.

Room temperature should not vary more than 2°C per hour.

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2-6 System Installation

2.3.7 Proper ventilation


Make sure that there is at least 0.25 meters of un-used space around the instrument on all three
sides, to enable proper ventilation. Please do not put any stationery or any other item by which
operating the analyzer becomes difficult.

Please make sure that there is no direct air flow of air-conditioner on analyzer.

2.4 Installation
The analyzer should be installed by the trained service engineer.

The analyzer is fully inspected before leaving the factory and carefully packed to withstand shocks in
transit.

On receiving the analyzer, check the package externally; make sure that there is no external visible
damage to the shipping container if there is damage please make a note of it, if possible photograph
it and inform the manufacturer immediately. Verify with the invoice, if all the boxes have arrived.

In case of damage, the necessary procedures of claiming the insurance is


initiated at customer site.

See the following section for more details:

Receiving Information

Unpacking the Analyzer

Accessories Checklist

Installing the Component of the Analyzer

2.4.1 Receiving Information


The analyzer is thoroughly tested before shipment and is packed carefully to prevent damage during
shipping and handling.

This section describes you the basic guidelines or information on analyzer's receiving instructions
and warranty.

See the following link:

Receiving instructions

Warranty instructions

2.4.1.1 Receiving Instructions


Please follow these guidelines on receipt of the analyzer:

Ensure that the arrows on the sides of the packages are pointing up. If the arrows do not point
up, make a remark about this on the invoice copy.

Visually inspect the outside of the package for rips, dents, or possible shipping damage.

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System Installation 2-7

Document any sign of damage on the bill of landing, regardless of how insignificant it may
appear. This is to protect your interests.

Notify your service representative that the analyzer system and its components have arrived.
Wait for your local service representative to unpack the system and open the packages.

Follow the unpacking and storage instructions provided on the outside of the package. Special
requirements such as refrigeration are clearly marked on the outside of the cartons and will be
included in the unpacking instructions and pack inserts.

2.4.1.2 Warranty Information

All analyzers are warranted against defective materials or workmanship for a period of one year
commencing from the date of the shipment of the analyzer.
This warranty does not cover any defect, malfunction or damage due to:

Accident, neglect or willful mistreatment of the product.

Failure to use, operate, service, or maintain the product in accordance with the applicable
Operator Manual and Service Manual

Use of reagents or chemicals of corrosive nature, though the unit is an open system allowing
the use of any commercial reagents from any manufacturer that are meant for such an
automated clinical chemistry analyzer.

2.4.2 Unpacking the analyzer


Unpack the analyzer carefully; otherwise you may damage the accurately
adjusted optical, mechanical and electronic assemblies.

The analyzer is packed carefully to prevent any shipping damage. Upon arrival, inspect the packing
according to the list and notify the carrier of any apparent damage. Follow the steps to install the
analyzer:

1. Remove the front panel of the wooden box by loosening the bolts. The front panel
on the wooden box is marked.

2. Remove the top and side panels of the wooden box as a whole section by
loosening the bolts from the back panel side.

3. Remove the four “Z” brackets, which are holding the analyzer on the pallet.

The “Z” bracket and the footrest may support the entire weight of the
instrument. Cautiously open the bolts of the “Z” bracket to prevent any personal
injury.

4. Lift the analyzer from the pallet & place at installation space. (Refer section Floor
Requirements).

5. Gently slide the Probe upwards, making sure you do not damage the probe, once
you have reached the top most position, rotate it and position it over the trough.

6. Gently slide the Stirrer arm upwards, making sure you do not damage the paddles,
once you have reached the top most position, rotate it and position it over the
trough. Remove the protective material.

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2-8 System Installation

7. Gently slide the CRU arm upwards to the top most position, making sure you do
not damage the probes, and remove the protective material and clean debris.

8. Remove the buffers that are present in the RGT & ASP areas, as well around the
CRU Stirrer and Probe.

The instrument is shipped, mounted on "Z" brackets; the "Z" bracket and the
four legs may support the entire weight of the instrument.
Open the bolts of the "Z" bracket to prevent any personal injury.
It is important to have leveling done of the place where analyzer is going to be
installed before placing the analyzer.

Contact authorized service personnel for removing analyzer from use for repair
and maintenance.
Follow regional or international norms for disposal of analyzer once end of
life.

2.4.3 Accessories checklist


The analyzer is fully inspected before leaving the factory and carefully packed to withstand shocks in
transit.

On receiving the analyzer, check the package externally; make sure that there is no external visible
damage to the shipping container. If there is damage please make a note of it, if possible photograph
it and inform the designated service personnel. Verify with the invoice, if all the boxes have arrived.

The accessories supplied with the analyzer are subject to change without prior
notice.

The shipment generally contains the following packages:

Analyzer wooden box

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System Installation 2-9

Accessories cardboard box (mounted on pallet)

Other accessories boxes (optional) could include

Printer

Computer etc.

SR.NO. ITEM DESCRIPTION QTY.


CODE

1 --- INSTALLATION & OPERATION MANUAL 1 NO.

2 --- SOFTWARE CD 1 NO.

3 115252 ASSEMBLY D.I. CAN 20 LTR, ADAPTOR & 1 NO.


STICKER_S

4 115253 ASSEMBLY WASTE CAN 20 LTR, ADAPTOR & 1 NO.


STICKER_S

5 115255 ASSEMBLY BIOHAZARD CAN 10 LTR, ADAPTOR & 1 NO.


STICKER_S

6 183987 ASSEMBLY DETERGENT CAN 20 LTR, ADAPTOR & 1 NO.


STICKER_S.

7 105403 REAGENT TRAY ASSY. 1 NO.

8 183232 REAGENT TRAY COVER ASSY. 1 NO.

9 104664 STANDARD SAMPLE TRAY (1-30) ASSY. 1 NO.

10 107051 RGT BOTTLE LOCATING PLATE – XL200 1 NO.

SHIPPER BOX CONTAINING

11 114769 CABLE USB JUMPER USB2.0 28X1P+ 24X2C - USB A 1 NO.


TO B 2.0 VERSION WITH FERRITE CORE (BOTH SIDE
A,B ) 1.8 METER

12 100343 TYPE E/F PLUG 1 NO.

13 105067 SAMPLE TUBE WITH BAR CODE LABELS. 10 NOS.

14 100634 TEST TUBE ADAPTER FOR MOULDED SAMPLE 35 NOS.


HOLDING PLATE

15$ 108159 ASSY. OF WASTE CAN TUBE & CAN CAP. ( Ensure 1 NO.
that cap is properly engaged on can)

16$ 108162 ASSY OF BIO-HAZARD CAN TUBE & CAN CAP 1 NO.
( Ensure that cap is properly engaged on can)

17$ 108160 ASSY. OF DI. WATER CAN TUBE & CAN CAP 1 NO.
( Ensure that cap is properly engaged on can)

18$ 184034 ASSY OF CLEANING SOLUTION CAN TUBE & CAN 1 NO.
CAP ( Ensure that cap is properly engaged on can)

XL-200
2-10 System Installation

19 182581 REAGENT BOTTLE (20ML) WITH CAP (White colour) 25 NOS.

20 182584 REAGENT BOTTLE (50ML) WITH CAP (White colour) 24 NOS.

21 --- REAGENT BOTTLES (20 ML.) WITH CAPS AND BAR 2 NOS.
CODE LABELS

22 --- REAGENT BOTTLES (50 ML.) WITH CAPS AND BAR 2 NOS.
CODE LABELS

23 100592 5 ML.REAGENT BOTTLE ADAPTER (NEW) 50 NOS.

24 109880 OUTER HOLDER FOR 5ML REAGENT ADAPTOR 10 NOS.

25 SCREW CAP (PP) OF 19mm RED COLOUR FOR 15 NOS


121410
BOTTLES

26 100660 PVC SUPPORT FOR 20ML REAGENT BOTTLE 25 NOS.

27 100536 RUBBER CUP FOR SAMPLE TRAY 10 NOS.

28 105970 RUBBER CAP FOR MOLDED TOP COVER_XL-200 11 NOS.

29 110318 CABLE TIE SIZE 2.5 MM X 100 MM KP138 25 NOS.

30 110317 MOUNT ADHESIVE 10 NOS.

31 110321 FLAT CABLE SUPPORT KP161E 05 NOS

32 109522 KIT FOR SYRINGE BUBBLE REMOVAL 1 NO.

33 102932 SAMPLE CUPS 300 NOS.

34 108605 FUNNEL 1 NO.

35 100679 CALIBRATION PLATE 1 No.

36 201209 GAUGE FOR PROBE CALIBRATION(XL-200/EM 200/


RES-920) 1 No.

37 100263 CUVETTE (4C:0609) 3 Nos.

38 - RGT BARCODE ALIGNMENT JIG. 1 No

39 106653 LEVEL SENSOR ASSY FOR 20LTR DI WATER CAN 1 No

40 184033 LEVEL SENSOR ASSY FOR 20LTR CLEANING SOLN


CAN 1 No

41 106655 LEVEL SENSOR ASSY FOR 10LTR BIOHAZARDOUS


CAN 1 No

42 106656 LEVEL SENSOR ASSY FOR 20LTR WASTE CAN 1 No

P. M. KIT (NEW) II

43 102851 CUVETTE DRIER 2 NOS.

44 105474 LAUNDRY ASPIRATION TUBING SET (2 PROBE 2 SET


CONSTRUCTION )

45 105475 LAUNDRY DISPENSING TUBING SET (2 PROBE 1 SET

XL-200
System Installation 2-11

CONSTRUCTION)

46 182220 PHOTOMETER LAMP ASSEMBLY 4 NOS.

47 104604 SET OF FUSES 1 SET

48 107613 10 MICRON FILTER (125MM LENGTH) 4 NOS

49 107580 BD SPINAL NEEDLE (25 GA 3.5IN,0.50X90MM, ITEM 1 NO.


405257)

50 101677 PROBE CLEANER 1 NO.

51 109712 WASHER FOR CRU KNOB 1 NO.

52 114435 FILTER 25 MICRON (75MM LENGTH) 04 NOS.

53 100675 COUNTER WEIGHT FOR DETERGENT ( SS316L) 01 NOS

54 107623 10-32 SPECIAL TAPERED THREAD WITH 1/4? HEX TO 2 NOS.


200 SERIES BARB 3/32? (2.25MM) ID TUBING,
NATURAL KYNAR PVDF; X220-J1A

55 108103 10-32 SPECIAL TAPERED THREAD WITH 1/4" HEX TO 2 NOS.


200 SERIES BARB 1/16" (1.6MM) ID TUBING,
NATURAL KYNAR PVDF; X210-J1A

56 1/16-27 NPT THREAD WITH 5/16" HEX TO 200 SERIES 2 NOS.


107621 BARB, 1/8"(3 MM) ID TUBING, NATURAL KYNAR
PVDF; 16230-J1A

57 1/16-27 NPT THREAD WITH 5/16" HEX TO 200 SERIES 1 NO.


108084 BARB, 3/32" (2.25 MM) ID TUBING, NATURAL
KYNAR, PDVF-16220-J1A

58 100937 SILICON TUBING R3350 2 MM X 4 MM (INTEGRA) 4 FEET

2.4.4 Installing the components of analyzer


The installation of the components should be performed by the trained service
engineer.

To avoid a shock hazard; ground the Analyzer, Computer, Printer and Monitor
using a 3 pin grounded electric outlet. Do not use an adapter, as it could
cause a loose contact and improper grounding.

Confirm that all cuvettes have been fitted properly into their respective slots on
the reaction tray and none of them are jutting out.

When removing or placing the cuvettes into their slots make sure that you grip
them by their sides and top end, never let the fingers or any sharp objects
coming in contact with the optical area of the cuvettes.

This section gives you the installation of some main components. It includes the following:

Sample Tray and Reagent Tray

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2-12 System Installation

Installing DI Water, Cleaning, Bio-hazardous and Waste Cans

Connecting communication cable between Computer and Analyzer

Printer installation

2.4.4.1 Sample Tray and the Reagent Tray


1. Unpack the Sample tray from the accessories box and hold the sample tray with your right
hand.

2. Gently place the sample tray into the Sample tray container.

3. Make sure that the index pin on the Sample Transport, slides into the index hole provided on
the sample tray.

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System Installation 2-13

4. Unpack the Reagent tray from the accessories box and hold the Reagent tray with your right
hand.

5. Gently place the Reagent tray into the reagent tray well.

6. Make sure that the index pin on the Reagent transport slides into the index hole provided on
the Reagent tray.

7. Place the respective tray lid over the Reagent Tray and Sample Tray.

2.4.4.2 Installing DI Water, Cleaning, Bio-hazardous and Waste Cans


1. Unpack the Float Sensors for the 4 Cans and place them on one side.

2. From the accessory box remove the 20 liters DI Water Can, 20 liters Waste Can, 10 liters Bio-
hazardous Waste Can and the 10 liters Cleaning solution Can, and put them on the floor.

3. Unpack Float Sensors cables and connect one end to respective connector (located on the
right panel of the analyzer) and connect other end to the respective Cans (Longer float sensors
with blue sleeves for DI Water, green sleeves for Cleaning solution, red sleeves for Bio-
hazardous Waste, and yellow sleeves for Waste).

4. Fill the DI Water Can with 20 liters of fresh DI water and unpack the tubing from the accessory
box. Install filter in DI water Can.

5. Take two separate tubes and connect one end to the Blue ringed outlet marked DI-WATER
and White ringed outlet marked DI-WATER LAMP provided on the analyzer. Connect other
ends to the SS (stainless steel) nozzle and White ringed nozzle on 20 liter DI Water Can.

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2-14 System Installation

Make sure that the tube connected to Blue ring on the analyzer should be
connected to SS nozzle on the DI water Can and the tube connected to White
ring should be connected to White ringed nozzle (for lamp cooling).

6. Now, fill 5 liters of DI water into the cleaning solution to prepare working cleaning solution: Add
50 ml of neutral cleaning solution to 5 liter of DI water to prepare a 2% solution.

7. Now take another tube and connect one end to the Green ringed outlet marked CLEANING
and other end to green ringed nozzle on 10 liter Cleaning solution Can.

8. Take two separate tubes and connect one end to the Red ringed outlet marked WASTE-3 and
BIO-HZ. Connect other ends to the red ringed nozzle on 10 liter Bio-hazardous Can.

9. Take one more tube and connect one end to the Yellow ringed outlet marked WASTE-2 and
connect its other end to the yellow ringed nozzle on 20 liter Waste Can.

10.Now connect the large diameter silicon tube to the analyzer outlet marked TROUGH WASTE
and connect the other end of the tubing into the 20 liter Waste Can.

Take care that all the above-mentioned tubes reach their respective containers
without any sharp bends or obstructions.

The waste consists of a natural drain. Make sure that the large silicon waste
tube from the analyzer to the Waste can is slant and in downwards direction
without any bends.
Failing to take the above precaution may cause a back flow of waste solution,
out of the manifold air release tube on waste manifold. Or could result in noisy
operation, big gargling sounds being created by the waste lines.

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System Installation 2-15

2.4.4.3 Connecting communication cable between Computer and Analyzer


Follow these instruction to connect the analyzer from the computer:

1. Unpack the USB cable from the accessories box, and connect its one end to the USB port of
the computer and other end to the USB connector located on the left side of the instrument,
as shown in figure below.

2. Connect one end of the power cord to the analyzer’s power outlet and other end to the main
power supply as shown in figure above.

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2-16 System Installation

Make sure that the On/Off power button should be in OFF condition before
turning on the main power supply.

The instrument is connected with the computer and ready to power on.

2.4.4.4 Printer Installation (DeskJet / Laser)


Check for following points before using application software to generate printouts:

1. Install appropriate printer driver on the analyzer PC.

2. Connect the printer to the analyzer PC.

3. Feed the paper to the printer and switch it ‘ON’.

4. There should be no paper jam or any other obstruction in the printer.

5. Print a test page from the analyzer computer to confirm correct printing.

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Part

III
3-2 Software Installation

3 Software Installation

This section guides you through the installation and un-installation procedure of MultiXL software.
You must read the instructions carefully before installing the software.
See the following sections in more details:

Pre-requisites

Software installation procedure

Read the necessary general safety guidelines before installing the softw are for the first
time. See Safety Instructions for more details.

3.1 Safety Instructions


The software installation and re-storing database should be done by the trained
person only.

3.2 Pre-requisites
Make sure that you should have the following pre-requisites before installing the software.

See the following section in more details:

System configuration

PC Settings required for Windows 10

Regional and Language settings for Windows 10

Test Loader Device

3.2.1 System Configuration

Before installing the MultiXL software, make sure that your computer should have following
minimum system configuration.

PROCESSOR Intel Core i3 (or higher)

OPERATING Windows 10 Professional 32/64 bit English Edition


SYSTEM
TBM OS of Windows 10 IoT 32/64-bit English

HARD DISK 500GB (minimum) or higher

RAM 4GB (minimum)

MONITOR Color Touch Monitor 17” (or higher),


Aspect Ratio 4:3 or 16:9, Resolution 1152 x 864 or higher

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Software Installation 3-3

PRINTER LaserJet / DeskJet Printer

3.2.2 PC Settings required for Windows 10


In case, *customized image of Windows 10 IOT is installed as Operating System,
required PC Settings will be applied automatically.
*A customized image of Windows 10 Embedded is provided by the analyzer
manufacturer, as Operating System for Analyzer PC.

The following PC settings are required before installing MultiXL.

Remove all memory resident software including anti-virus software from the Analyzer PC if
installed. Use the following procedure:

Click Start button, and click Control Panel. Now, under the Category view, go to
Programs > Programs and Features. Select the desired anti-virus software from the list,
and click Uninstall.

Remove firewall, automatic update, other security software and from the Analyzer PC.

Click Start button, and click Control Panel. Now, under the Category view, go to System
and Security > Windows Firewall, and click on the link Turn off Windows Firewall on
or off. Now select the option Turn off Windows Firewall (not recommended), and then click
OK button.

To turn off automatic updates, under Control Panel, go to System and Security >
Windows Update, click on the link Change settings, and select the Never check for
updates (not recommended) from the drop down list, and click OK.

Do not run any other application on the Analyzer PC during batch run on Analyzer.

Ensure that a default printer (Laser Jet / Desk Jet) is configured and connected to Analyzer
PC. Set appropriate printer as default printer.

Delete the “Microsoft Office Document Image Writer” and “Microsoft XPS Document
Writer” from the system.

Click Start button, and click Control Panel. Now, under the Category view, go to
Hardware and Sound > Devices and Printers. Right click on the Microsoft Office
Document Image Writer, and choose Remove Device to delete. Similarly, delete
“Microsoft XPS Document Writer”.

Windows Login User requires Administrative privileges to Install and Run the Application.

Disable Screen-savers and Power Management on Analyzer PC before starting the Application
Software.

Use the following procedure for disabling the screen saver and power management:

1. Open Screen Saver Settings by clicking on Control Panel > Appearance and
Personalization under Category view, click Personalization, and then click Screen
Saver.

2. To turn off all screen savers, under Screen Saver, select (None) from the drop-down list, and
then click OK.

XL-200
3-4 Software Installation

3. Now click on the link Change Power Settings / Power Options (Applicable only if option is
available). The following screen will be displayed

4. Click on Balanced radio-button and then the corresponding Change plan settings button as
shown above.

Set Turn off the display to Never

Set Put the computer to sleep to Never

5. Click on the link Change advanced power settings. The following screen will be displayed.
Set Turn off hard disk after to Never as shown below;

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Software Installation 3-5

6. Similarly, apply same settings to Power saver option. Repeat the step 3 to 6.

User Account Control Settings

Follow these steps to change the user account settings:

1. Select Control Panel. Now, under the Category view, go to System and Security >
Security and Maintenance . Move Pointer to Never Notify and click OK. The
following screen will be displayed.

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3-6 Software Installation

2. Now, click on Change User Account Control Settings option as shown above. The
following screen appears;

3. Move Pointer to Never Notify and click OK

XL-200
Software Installation 3-7

4. You must re-start the analyzer PC to turn on the user account control

3.2.3 Regional and Language settings for Windows 10


Use the following procedure for setting the regional and language options:

Ensure that the following regional and language settings are appropriate.

Note that these are critical settings for the communication with the analyzer.

Go to Control Panel > Clock, Language, and Region options > Change the date, time and
number format.

a. Following should be the settings for Formats tab:

XL-200
3-8 Software Installation

b. To set Number and Currency, Click on Additional settings

XL-200
Software Installation 3-9

c. Following should be the Location tab

XL-200
3-10 Software Installation

d. Following should be the settings for Administrative tab:

3.2.4 Test Loader Device


Test Loader Device is used to scan the details of system packs for Closed channel reagents. This
device located inside the analyzer

Test Loader Functionality

Test Loader device scans the details of System Pack Reagent kits including lot number,
expiry date, pack size etc.

Analyzer performs open/closed-channel tests only after scanning the System Pack Reagent
kits / special cards.

Analyzer performs closed channel tests based on pack size (test count) of respective
reagent kit.

Analyzer performs open channel tests not exceeding the total test-count, as read from
System Pack Reagent kits. Open channel tests can also be loaded using special cards
which may be available for purchase from manufacture in special circumstances.

Once open test-counts are exhausted, it is not allowed to perform further open tests, until
user scans the new System Pack Reagent kits or special cards..

System will intimate user during run if open test count reaches 10 & below.

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Software Installation 3-11

3.3 Software Installation Procedure


This section guides you through MultiXL software installation process.

Follow the instructions in this section in case you are installing the application software for the first
time on the computer i.e. there is no previous installation of the software on that computer. See the
following sections in more details:

Installing MultiXL

Installation of Database

Installing Team Viewer

Upgrading MultiXL Software (to upgrade MultiXL from existing version to the new version)

Database Utility Options

Accessing MultiXL Software

3.3.1 Installing MultiXL


Follow these instruction for installing the application:

1. Insert the installation CD into the CD drive of your computer. On inserting the CD, the MultiXL
Installation screen will be displayed.

OR

Go to Windows Explorer, right-click on CD/DVD ROM-Drive, and click on AutoPlay option.

OR

Go to Windows Explorer. Right-click on CD/DVD ROM-Drive. Click on Explore and


double-click on Launcher.bat.

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3-12 Software Installation

2. Click on Install MultiXL Application & Database link and follow the on-screen instructions.

OR

Click on the Browse this CD link. The software installation CD contains the following folders
and files as shown in the figure below:

3. Open Setup folder, and double-click on the setup.exe.

On clicking, the following screen will be displayed.

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Software Installation 3-13

This screen will not be displayed if .NET framework is already installed


on your computer.

4. Click Accept to continue. On clicking, the following screen will be displayed.This screen will
not appear if SAP Crystal Reports Run-time Engine for .NET Framework is already installed
on the Analyzer PC.

This screen will not be displayed if Crystal Reports is already installed on


your computer.

5. Click Accept to continue. On clicking, the following screen will be displayed.

XL-200
3-14 Software Installation

This screen will not be displayed if SQL Server 2008 R2 Express Edition is
already installed on the analyzer computer.

On clicking Accept, the following screens will be displayed in a sequence

XL-200
Software Installation 3-15

Wait until the setup wizard is visible on the screen as shown below.

6. Click Next. On clicking, the following window will be displayed.

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3-16 Software Installation

On keeping Configure Database check-box checked (ticked), the installer will create or
upgrade the database along with the installation of MultiXL.
(In case, the Database is found present then the existing database will be upgraded to the
latest version. When the Database is not found then the installer will create a blank
Database).

In case, Configure Database option is unchecked; the installer will not create/upgrade the
database and you have to install it manually. Refer section Installing Blank Database for
more details.

7. Click Next. The following screen will be displayed.

The installer will install the software in the default location C:\Program Files(x86)\MultiXL.

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Software Installation 3-17

The installation in a location, different from the default one, is not


recommendable.

8. Ensure that “Everyone” is selected, and click Next. On clicking, the following window will be
displayed. Click Next to confirm the installation.

9. On clicking Next, the installation is started and the status will be displayed, as shown below.

The following screen will be displayed if the Configure Database option is selected.

XL-200
3-18 Software Installation

Once the above operation is completed, the software icon will be created on the desktop and
the Installation Complete screen will be displayed.

10. Click on Close to close the screen and restart the computer.

Now double click on the MultiXL icon from the desktop or choose Start > All
Programs > MultiXL to start the application.

The Detect Regional Settings screen will be displayed and the


application halts in case, if the language setting in the Formats tab is
other than English (United States).
.

XL-200
Software Installation 3-19

USB drive can be accessible through Admin login only.


To copy software data to USB drive, use Utility > Backup screen. See section
Copy Data to External USB Storage for more information.

Full MultiXL database backup and log files are automatically archived in the C
drive under MultiXLLog folder, after every seven days before system shutting
down.

Restricted user account for MultiXL: To install and uninstall any application from the PC, you
must be logged on as (windows) user “Admin”. To log in to the administrative account, go to
Start > Shutdown > Logoff and then click the Administrator icon and provide the
administrator password.

Along with MultiXL installation, Consumable Management Utility will get


installed on analyzer PC which can be used to load value files and default test
parameters.

3.3.2 Installing Database


The installation and restoring database should be performed by the trained
person only.

Database installation is required only if the Configure Database option is de-selected (unchecked)
during installation (Refer step 10 of section Installing MultiXL).

In case, Configure Database option is selected (ticked by default) during Software Installation then
the Database will be created / upgraded automatically as part of installation. (Database, when
already exists, will be upgraded to the latest version. When database is not found on PC, then the
installer will create a blank database).

In case, the Configure Database option is not selected, then the database should be installed
manually, as follows.

Always use Database Utility folder from the software CD, which consists of files
required to install or upgrade the database.

See section Installing Blank Database for more details.

In case user is getting “Operating System error 5 (Access denied)” while


performing the above mention steps then refer section 10.2.1 SQL Server 2005
Configuration for SQL Server 2005 Settings.

3.3.2.1 Installing Blank Database


For installing the blank database from software CD, use the following instructions:

1. Click on Run Database Utility from the MultiXL installation screen as shown below.

XL-200
3-20 Software Installation

OR

Open the Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.

Default Database folder is the one from where the DatabaseUtility.exe is running. Database
folder refers to the Database, required for performing various operations and storing the result
data.

2. Click on CHECK DATABASE. This command will check for the existing database on your
computer. If no database is available, a message is displayed on the following screen.

3. Click on CREATE DATABASE.

This will create the database from the location specified on the screen. This is the default
location where the blank database is stored in software installation CD. (To restore the
backup of new database, you need to change the location using BROWSE FILE button.
Refer section Restoring Backup of New Database in section Change Database more
details).

For example, in the above screen, the database location is E:\Database Utility\MultiXL BKP.

XL-200
Software Installation 3-21

If Archive is not available, then utility will ask for Blank Database location and the following
window will be displayed. Now select the blank database file MultiXL.BKP from the software
CD, and then click Open.

5. After some time, the database will be created successfully and the following screen will be
displayed.

6. Once the database is created, click CHECK DATABASE to ensure the proper creation of the
database. The following screen will be displayed.

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3-22 Software Installation

The above screen indicates that the database is created successfully. Click Close to exit from
the utility screen. Now you can access the MultiXL application. (Refer section Accessing MultiXL
Software for more details).

Make sure that all software versions are installed correctly.

To check the installed software versions, go to Service Check screen, right click
on the Misc Commands button, and choose Software Version option.

3.3.3 Installing Team Viewer

Team Viewer is used to access analyzer computers, which makes it an ideal solution for Remote
Monitoring and Trouble Shooting purposes.

Pre-requisite for Analyzer PC and Remote PC:

a) Internet connection availability - uninterrupted with good speed.

b) Team-viewer is not blocked in System Settings for PC/Network Security.

Team Viewer connectivity depends upon the Internet speed available at the
Lab/Site and load on analyzer PC. Team Viewer uses remote desktop
technology to control a computer from an alternate location. The main cause of
lag when controlling a remote computer is network speed.

Regular PC cleanup and maintenance should be carried out to keep your PC


running at optimum speed. Disk Cleanup application scans and deletes
unnecessary files and Disk Defragmenter improves performance by eliminating
the gaps in data. Use the Start menu's search box to locate these programs.
Viruses also impact performance. Update your virus definitions and complete a
full system scan.

It is not recommendable to use Team Viewer remote control session during


Batch RUN with Actual Patient samples on the analyzer, as it may slow-down /
interrupt the system performance.

Installation Procedure:

1. On insertion of CD on Auto-play, MultiXL Installation screen will be displayed with the option to
install Team Viewer.

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Software Installation 3-23

OR

1. Go to Windows Explorer and Right Click on CD/DVD ROM-Drive and Click on Auto-play.

2. Click on Install Team Viewer. On selection of this option, following pop-up appears;

3. Team Viewer installation is carried out at default installation location C:\Program Files\
TeamViewer.

4. After Team Viewer is installed successfully, above screen will be closed automatically and user
will be redirected to the Launcher Screen.

Start-up procedure for Team Viewer remote support

XL-200
3-24 Software Installation

Open Team Viewer 10 Host from Windows Start menu. Following screen appears;

Team Viewer ID (Your ID marked in Red in above image) is unique for every device. This ID of the
Analyzer PC is required for connecting another Remote PC through TeamViewer. Password is
“tbm1234@”, by default.

Password is pre-configured by default, during installation of TeamViewer


Host.

Analyzer user / operator has to share Your ID (Team Viewer ID marked in RED) to the support
team for Remote Support (Remote control session on Analyzer PC).

Do not change the default password for the seamless remote support.

3.3.4 Upgrading MultiXL Software


If MultiXL software is already installed on your computer and if you receive a newer version of
software, then the following steps should be performed.

Upgrade Software

Upgrade Database

Take a database backup through Utility > Backup, before proceeding with
software upgrade.

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Software Installation 3-25

3.3.4.1 Upgrade Software

You can upgrade the software version by un-installing the existing software version from the PC and
installing the newer version from the CD as follows.

Un-installing Software

To un-install the software, do one of the following:

1. Click on the Uninstall MultiXL Application from the MultiXL Installation screen as shown
below.

OR

For Windows 10 operating systems, click Start button on the desktop, under Category
view, go to Control Panel > Programs > Programs and Features.

2. Select the MultiXL, and then click Uninstall. On clicking, the software will be removed
from the computer.

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3-26 Software Installation

To uninstall the MultiXL software you must be logged on as user


“Administrator”.

Installing Software - New version

Refer section Installing MultiXL for more details.

3.3.4.2 Upgrade Database


Upgrade the database using the software CD of the newer version whenever you install the new
software version.

Database can be upgraded to match the newer software version without deleting the database of the
existing version.

Ensure to take database backup before upgrading the database.

Upgrading Database

Database is upgraded using upgrade script file. The upgrade script is


provided in the application software CD in the Database Utility folder.

Follow these instructions for upgrading the database:

1. Click on the Run Database Utility link from MultiXL Installation screen as shown below.

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Software Installation 3-27

OR

1. Open the Database Utility folder from the software installation CD. Double-click on
DatabaseUtility.exe.

2. Click UPGRADE DB.

A window will appears to select the upgrade script file, see the following screen.

Select the upgrade script file from the software CD, and then click Open.

This will start the upgrade process. If archive database is not available then the utility will
prompt to select the path for blank database and the following screen will be displayed.

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3-28 Software Installation

The upgrade script file is provided in the application software CD in


the Database Utility folder.

4. Click OK and select the blank database file MultiXL.BKP from the software CD, and then
click Open.

5. After some time, the database will be upgraded successfully and the following screen will
be displayed.

Click to close the database utility screen.. After successful database up-gradation,

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Software Installation 3-29

you can access the MultiXL application. Refer section Accessing MultiXL Software for
more details.

After installing the new software version, if the database is not upgraded
using the upgrade script file provided in the Software CD then the following
screen will be displayed on starting the application software. This screen
indicates the software and database version mismatch.

In case, the Software and Database version mismatch screen is displayed; upgrade the
database using the script file, provided in the software CD. Refer section Upgrading
Database for more detail.

If the problem is not resolved, then call service engineer for help.

Make sure that all software versions are upgraded correctly.

To check the installed software versions, go to Service Check screen, right


click on the Misc Commands button, and choose Software Version option.

3.3.5 Database Utility Options


The Database Utility can be used to take the Database Backup or change the Database.
See the following section for more details:

Database backup

Change database

Restore archive database

3.3.5.1 Database Backup


Follow these instructions for taking the backup of database:

1. Click on Run Database Utility from the MultiXL Installation screen.

OR

1. Open Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE. The following screen will be displayed.

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3-30 Software Installation

3. Press BACKUP DATABASE key. The following screen will be displayed.

4. Select the path to store the backup file, and then click Save. On successful completion of
database backup, following screen is displayed.

If archive database is present then backup will be stored with “ARH” extension with the same
default file name.

For example: In this case archive backup will be stored on the same path with file name
“MultiXL2522011.ARH”. The default file name contains “MultiXL” (the application name),
followed by date, month and year.

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Software Installation 3-31

3.3.5.2 Change Database


In case, if you wish to change the database, you must delete the existing database and then restore
the backup of another database using database utility,

It is recommended to change the database with proper guidance of expert


service engineer. Improper installation may impact the calibration of the
analyzer, in addition to loss of data such as QC data and chemistry calibration.

Before installation, you should take the backup of the database before deleting
or changing the database.

Database can be changed in two parts:

Delete (existing) Database

Restore Backup of another Database

Deleting Existing Database

Follow these instructions for deleting the database:

1. Click on the Run Database Utility from the MultiXL Installation screen.

OR

1. Open the Database Utility folder from the software installation CD, and double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE to check whether the database is present.

3. Click on DELETE DATABASE to delete the existing database. The following screen will be
displayed.

XL-200
3-32 Software Installation

4. Click on Yes to continue with database deletion. On clicking, the warning message will be
displayed to re-confirm the deletion.

5. Click Yes to continue. On clicking, a message will be displayed to take the database
backup before deletion.

6. Click Yes to take the backup. The following window will be displayed. Select the
appropriate location for saving the backup database.

On clicking No, Production (Live) & Archive database will be deleted without
taking the database backup.

Best Practice: Backup database before deleting the same.

7. Click Save to save the database.

XL-200
Software Installation 3-33

On clicking, a copy of database will be saved in the desired location. The following screen
will be displayed after successful deletion of the database.

Restoring Backup of New Database

Follow these instructions for deleting the database:

1. Click on Run Database Utility from the MultiXL Installation screen.

Or

1. Open Database Utility folder from the software installation CD. Double-click
DatabaseUtility.exe.

2. Click on CHECK DATABASE.

3. In the DATABASE RESTORE UTILITY window, click on the BROWSE FILE. Select the
location where the backup database file is saved.

4. Select the appropriate database file and then click Open. The following screen will be
displayed.

5. Click on CREATE DATABASE to create the database. The database create the database
following screen will be displayed.

If the Archive is not available then utility will ask for blank database location.

XL-200
3-34 Software Installation

6. Click OK and select the blank database file MultiXL.BKP from the application CD.

7. Click Open. After successful creation of database, following screen is displayed.

8. Click on CHECK DATABASE to ensure proper creation of the database.

9. Click to close the database utility screen.

Now you can access the MultiXL application. (Refer section Accessing MultiXL Software for more
details)

XL-200
Software Installation 3-35

3.3.5.3 Restore Archive Database


Restoring Archive Database

Follow these instructions to restore the archived database:

1. Click on the Run Database Utility from the MultiXL Installation screen.

Or

2. Open the Database Utility folder from the software installation CD. Double-click
DatabaseUtility.exe.

3. Click on RESTORE ARCHIVE.

4. The following window will be displayed. Select the appropriate location where the archive
database is saved and then click Open.

5. After restoring the archive database successfully, the following screen will be displayed.

3.3.5.4 Taking Diagnosis Backup


This button is used to take the database backup for diagnosis which will be without patient
demographics to support patient privacy policy.

Diagnosis backup can be used by support team only for troubleshooting purpose.

Following are the list of demographics that are excluded from the diagnosis database: Patient Name,

XL-200
3-36 Software Installation

Patient ID, Patient Address (line 1, 2 and 3), Patient Tel. No. Patient Remarks, Area i.e. Location of
the Sample Collection, Reference Doctor Analyst.

To take the backup of the data base, use the following steps:

1. Run Database Utility.

2. Click on DIAGNOSIS BACKUP.

3. On clicking, the diagnosis backup database will be created with a file name and saved in the
location C:\MultiXLLog folder. See figure below.

4. For example, diagnosis backup created on 30 Sept 2013 at 11:30:45 am will have file name
“MultiXL_20130930113045.DIAG”.

5. After the completion of backup, user should copy the file name and send to support team for
diagnosis.

3.3.6 Accessing MultiXL Software


MultiXL screens are best viewed with 1152 * 864 resolution.
On starting the application, the PC resolution will be automatically changed to
1024*768 pixels, only if the resolution is different than specified. On closing
MultiXL, the previous resolution will be restored.
On successful installation, the MultiXL software application will be launched automatically at every
PC startup.

When the MultiXL application is running, all windows shortcut keys (e.g. left and right window keys,
etc) available on the keyboard is not accessible.

To access the software do one of the following:

Turn on the analyzer PC. MultiXL application will start automatically OR

Double click on the MultiXL icon created on your desktop OR

Go to Start > All Programs > MultiXL

When starting MultiXL first time, the product login screen as shown below will be displayed.

XL-200
Software Installation 3-37

Product Login is critical (one-time) stage. Software is configured suitably based


on the inputs in this screen. Please contact Service Engineer, in case Product
Login details are not available on Software CD.

Enter the appropriate details in the PRODUCT LOGIN, PASSWORD and LOCATION. Then, click
OK. On clicking, the login screen as shown below will be displayed.

This screen will be displayed every time, on starting MultiXL.

Enter the following details, and then click OK. You may use this Login details for the first time and
create the other login IDs with appropriate user access rights. See section User Rights for more
details.

Login ID : User

Password : User (Case – sensitive)

The main screen will be opened as shown in the following screen.

XL-200
3-38 Software Installation

MultiXL version number with "TLS" indicates Test Loader System.

Error System is reported if combination of embedded software version is not


proper or any hardware issue.

XL-200
Part

IV
4-2 Safety Information

4 Safety Information
Before operating the analyzer, it is necessary that you read and understand the safety instructions,
safety precautions and warning labels listed below.

Safety Symbols

Warning Labels

Safety Precautions

Read all safety notices carefully and make sure you understand them.

4.1 Safety Symbols


Before you attempt to use the analyzer, you must be fully familiar with the following symbols and
their meanings:

Symbols Meanings

DO NOT TOUCH

BIOLOGICAL HAZARD

SERIOUS ELECTRIC SHOCK

DANGER, WARNING, CAUTION

DANGER OF BURNS

BIOLOGICAL RISKS

BATCH CODE AND SERIAL NUMBER

4.2 Warning Labels


The following warning labels are affixed on the analyzer on different places that are the potentially
hazardous.

Labels Places

XL-200
Safety Information 4-3

On the 4 piece top cover plates

On the 4 piece top cover plates

On the 4 piece top cover plates

On the Bio-hazard Waste Can (10 Liters)

On Waste Can (20 liter)

On Cleaning Solution Can (10 liter)

On DI Water Can (20 liter)

XL-200
4-4 Safety Information

4.3 Safety Precautions


Read the necessary safety instructions carefully, before using the analyzer for the first time.

Only qualified and trained personnel should use the analyzer and perform the procedures
described in this document.

General safety:
Danger of injury to hands by moving parts. During operation, do not touch auto
sampler unit, reagent unit, arm probe and any other moving mechanical parts in
the analyzer. During operation, shut cover all the time.

Pay attention not to exceed the time and volume necessary for diagnosis.

Keep monitoring the behavior of the whole system in order to detect any
malfunction.

Take immediate corrective measures including shutdown of operation when any


malfunction is detected in the analyzer.

Avoid possibilities of any direct access by the patients.

Turn off the power after every operation so that control is restored to its previous
state as directed.

Do not remove the line cord plugs from receptacles by pulling the cords so that
no undue stress is developed in the cords.

Wipe the probe tips of SRPT several times with cloth or by rubbing alcohol
before the analyzer is used. At this time, do not forget to put medical rubber
glove. Pay attention to prevent bare skins of hands or arms from being touched
by or pricked with the probe tip.

Pay attention to the storage area.

Keep the analyzer out of the rain and any other water splash.

Avoid areas that are adversely affected by atmospheric pressure,


temperature, humidity, ventilation, sunlight, dust and air containing salt,
sulfur, etc.

Pay attention to inclination, vibration, shock (including shock during


transportation), etc.

Avoid areas adjacent to the storage room of chemicals or areas that are
likely to generate gasses. Avoid areas that are likely to be subject to
inclination, vibration and shock.

Organize and store parts and cords associated with the analyzer after they
have been cleaned.

Keep the analyzer clean not to cause any inconvenience to the next use.

In the event of trouble in analyzer, do not troubleshoot by your own. You must
contact the authorized service personnel.

XL-200
Safety Information 4-5

Prohibit any alteration and/or modification to the analyzer without permission by


manufacturer.

Electrical safety:
The access to the conductive parts within the analyzer may cause serious
electric shock. When removing parts, make sure to shut off the main power
supply from the socket. Leave any maintenance and repair of electrical parts
inside the equipment to qualified service personnel.

Always replace the halogen lamp with the new lamp only after been kept off for
30 minutes, to avoid the danger of burns. Keep hands away from the glass part
of the new halogen lamp. Make sure that there is no crack or breakage in the
glass part.

Biological safety:
Never touch patients' samples, SRPT probe, reaction cuvettes, and stirrer
paddles with bare hands to prevent operator from possible infection. Wear
disposable medical rubber gloves to keep skin from direct contact with patients'
samples.

Treat the drain water as infectious waste. Collect the drain water in reserve can
and allow it to be disposed of by expert distributors.

Wipe the probe tip of SRPT several times with cloth or by rubbing alcohol before
the analyzer is used. At this time, do not forget to put medical rubber gloves.
Pay attention to prevent bare skins of hands or arms from being touched by or
pricked with the probe tip.

Treat the drain water as infectious waste. Collect the drain water in reserve can
and allow it to be disposed of by expert distributors.

Sample handling:
Do not touch the samples, mixtures and waste liquids with bare hands. Give
special consideration to keep skin and mucous membrane from contact with
reagents to prevent operator from possible infection. Always wear disposable
medical rubber gloves, goggles, etc. to keep skin and mucous membrane from
contact with reagents.

Always follow the laboratory's safety protocol for cleaning and decontaminating
the Sample & Reagent tray, Bio-hazard and Waste can.

In case any samples come in contact with your skin, thoroughly rinse the area
that came in contact with the sample and consult a physician.

Immediately wipe off any contaminants from the system.

Reagent handling:
Danger of cauterization and skin poisoning through contact with reagents.

After unpacking the reagents, be sure not to allow dust, dirt or bacteria to come
in touch with the reagent.

Always keep reagents in cool place.

XL-200
4-6 Safety Information

Do not use reagents that are expired.

Handle a reagent gently to avoid formation of bubbles.

Take care not to spill the reagent. If it spills, wipe it off immediately using a wet
cloth.

Always take the reagents by the approved vendor.

If a reagent comes in contact with your eye, wash it off immediately using
plenty of water, and take medical treatment at once.

If you swallow it inadvertently, call for a doctor immediately and drink plenty of
water.

Some reagents are strong acids or alkalis. Exercise great care so that your
hands and clothing do not come into contact with reagents. If your hands or
clothing come into contact with either reagent, immediately wash them off with
soap and water. If a reagent comes into contact with your eye(s), immediately
rinse with water for at least 15 minutes..

Maintenance and checks:


Incorrect cleaning and maintenance can cause damage to personnel and
equipment. Perform cleaning and maintenance according to the procedures
described in this publication.

It is important for the analyzer and its associated parts to be periodically


checked.

Arm probe

Cuvette rinsing unit (laundry)

Stirrers

Syringes

Refer section Replacement schedule for spares and consumable for more
details.

Ensure that the analyzer operates normally and correctly, when it is reused
after being unused for some time.

Perform Daily, Weekly, Monthly and Annually maintenance procedures as


directed in the operator manual. Refer section Maintenance for more details.

In the event of trouble in analyzer, do not troubleshoot by your own. You must
contact the authorized service personnel.

Prohibit any alteration and/or modification to the analyzer without permission by


manufacturer.

XL-200
Part

V
5-2 Technical Specifications

5 Technical Specifications
This section tell you the technical specification of the system in detail.

See the following sections:

General specification

Sampling unit

Reagent unit

Reaction unit

Optical absorption measurement unit

Data processing

Installation Condition

Accessories/Consumables

Computer Specification

The specifications are subject to change without prior notice.

5.1 General specification

Item Description

Throughput 200 tests/hour for cycle time of 18 seconds


400/500 tests/hour with ISE (Optional)

System type Discrete, open, automated, random access, patient prioritized, ONE or
TWO Reagent system Reagent system.

Sample Serum, Urine, CSF, Plasma, Whole Blood, Others.

Measurement principle Turbidimetric Immunoassay, Colorimetry (Rate/End Point), Ion Selective


Electrodes

Applicable analytes Photometric assays: Enzyme, lipid, protein, sugar, nitrides, inorganic
substances, complements and others.
Turbidimetric assays: IgG, IgA, IgM, C3, C4, RF, CRP, ASO, Transferrin
and others.
ISE Potentiometric Assays: Na, K, Cl (optional)

Test method Absolute measurement, Relative measurement, ISE (optional)

On board Reagent 50 test items maximum, 54 test items with ISE. (4 out of a total capacity
Positions of 50 bottles can be used for diluents) – 1 for Sample Diluent, 1 for Urine
Diluent, 1 for Wash Program and 1 for Urine ISE Diluent

XL-200
Technical Specifications 5-3

Programmable No Limit for Programmed Tests or Calculation Items


parameters

Assay modes 1-Point, 2-Point, Rate-A, and Rate-B.

Sample volume 2-70 µl (adjustable in 0.1 µl step).

Reaction volume 180 µl to 550 µl.

Reaction temperature 37 °C.


Temperature stability: ± 0.2 °C.

Reaction time Depends on the designated cycle time and number of reagents used For
1 step assay (using R1)
648 seconds (10 minutes 48 seconds) for a cycle time of 18
seconds
For 2 step assay (using R1 and R2)
1st reaction 306 seconds (5 minutes 6 seconds) + 2nd reaction
324 seconds (5 minutes 24 seconds) for a cycle time of 18
seconds

Test selection Setting of tests one by one or with profile key for each sample.
Group order entry is possible.
Setting from host computer via interface (optional).

Maintenance Programmable maintenance actions: Prime, Wash (Sample Probe


Wash, Reagent Probe Wash, Acid and Alkali Wash and Cuvette Wash),
ISE Calibration and Maintenance

Barcode identification Sample barcode formats - NW7, Code 39, Code 128, ITF, 2 of 5 standard,
UPC A.
Reagent barcode ID (ITF).
During batch run, barcode scan for reagent is performed.

Water supply unit Water consumption: Less than or equal to 7.5 liters/hour.
Manufactures and supplies: Type 2 quality (by NCCLS standards) ion
exchange water (optional).

Quality control 30 types of control parameters

System Warm-up Time 5 minutes system warm-up time.

Safety mechanism Vertical obstruction detection, Capacitance based liquid level sensing.

Noise level Less than 65 dB with cover closed.

System interface Analyzer – All in one PC: USB bi-directional

Optional Electrolyte measurement unit (for Na, K, Cl)


A4 size DeskJet color printer, Off-line
PC – Host computer: TCP/IP bi-directional
Automatic water supply from an outside External DI water unit (input
water pressure 0.5~3.5 kgf/cm^2)
Multimedia Speakers

XL-200
5-4 Technical Specifications

5.2 Installation Condition

Item Description

Power source/ AC 220 V ± 10%, 50 ± 1 Hz or AC 110 V ± 10%, 60 ± 1 Hz.


consumption Power consumption: 600 VA (excluding PC/Printer/Monitor).

Fuses 5A for 220V and 10A for 110V input supplies

Drainage Used sample (concentrated waste solution) and washed sample (diluted
waste) are to be drained separately.

Ambient temperature 15 – 30 °C.


Variation during operation: Less than ± 2 °C per hour.

Relative humidity 40 – 80% free from water dew formation.

Dimensions 810 mm (W) * 700 mm (D) * 600mm (H).

Weight Approximately 120 kg.

Operating Pressure 85kPa – 110kPa

5.3 Sampling unit

Item Description

Sample container Blood collection tube 10 ml (16 x 100 mm), 7 ml (14.5 x 84 mm), 5 ml
(13 x 75 mm).
Adaptors will be provided for 5 and 7 ml tubes.
Cup:2 ml Sample Cup, 500 µl Standard Cup

Sample Disk Sample tray


Outer Most Track: 15 positions for placing barcode tubes.
Middle Track: 15 positions for placing barcode tubes.
Innermost Track: 9 positions for placing Sample cup and
Standard cup without barcode.

STAT samples Place anywhere on the Sample Tray.


STAT samples are measured preferentially.
Interrupt permitted even during analysis.

Sampling Pipetting system with plunger, driven by stepper motor.


Sample volume: 2-70 µl (adjustable in 0.1 µl step).

Pipetting mode Discharges set volume of sample into cuvette or the ISE module
(optional).

Sampling probe & Micro-pipette with level sensor.


Reagent Probe Washing solution.
Outside: Preheated de-ionized water.
Inside: Preheated de-ionized water.
Equipped with vertical obstruction detection facility to prevent probe

XL-200
Technical Specifications 5-5

crash.

Sample dilution Dilution ratio: 2 to 150 times.


A cuvette is used as dilution vessel.
Set amount of diluent and sample is dispensed into a cuvette by probe.
Dilution possible for repeat run.
Direct reduced/increased volume runs are also possible.

Repeat run Execution by repeat run list or auto execution.


Auto execution according to abnormal marking and/or range over.
Reduced/increased volume repeat run also possible.

Sample identification Sample bar-code format - NW7, Code 39, Code 128 (A,B,C), ITF, 2 of 5
standard, UPC A and 3-18 digits (depending on the length of the
barcode)
Position ID for non barcoded samples

Dead Volume

5.4 Reagent unit

Item Description

Type Turn table type reagent tray.

Reagent tray Common reagent tray for reagent 1 and reagent 2.

Reagent cooling 8 ± 4 °C cooled with refrigeration unit.


temperature

Reagent bottles 25 positions for placing 20 ml bottles


25 positions for placing 50 ml bottles

Reagent dispensing Pipetting system with plunger, driven by stepping motor.


R1 dispensing in the 1st cycle
R2 dispensing in the 17th cycle

Reagent steps 1 step or 2 step

Reagent volume Reagent 1: 50 – 300 µl (adjustable in 1 µl step).


Reagent 2: 0 or 10 – 200 µl (adjustable in 1 µl step).

Dead volume

Reagent identification Sample bar-code format - ITF.


Reagent bar-code ID (18 digit barcode readability).

XL-200
5-6 Technical Specifications

Residual volume Calculated by countdown system as well as measured by capacitance


information type level sensor and displayed on screen.

Reagent positions Total 50 positions which can be used for accommodating reagent 1/
reagent 2

Reagent protection Reagent cover to protect from evaporation, dust, and direct light.

Carry over actions Detergent or Reagent Wash or System Wash and Cuvette Skipping given
for Carry Over Pairs

5.5 Reaction unit

Item Description

Type Turn table.

Reaction tray Rotating tray.


Number of reaction cuvettes: 45.
Temperature control: Turn table direct heating by foil heaters.

Reaction temperature 37 ± 0.2 °C

Cuvettes Reusable.
Number of reaction cuvettes: 45.
Dimensions: 5 x 4.9 mm.
Optical path length: 5 mm (factor to be fed for 10 mm).
Material: Hard glass made of Quartz
Volume: 700 µl.
Reaction liquid volume: 550 µl maximum, 180 µl minimum.

Reaction liquid mixing Type: Immersion mixing by rotating mixers.


Singe mixer (3 variable mixing speeds).
Mixing steps.

The 1st position: Right after Reagent 1 and sample dispensing


into the respective cuvette

The 2nd position: After Reagent 2 dispensing in the cuvette


containing Reagent 1 + sample

Cuvette washing Type: By the automatic washing system.


The reaction waste is aspirated out, then cuvette is washed by washing
solution and repeatedly by DI water, finally residual liquid is removed.
Number of washing operation steps: 7 steps.
Reaction waste removal: 1 step
Washing: 5 steps
Residual liquid removal: 2 steps
Number of washing solution application.
Detergent solution: 1
Ion exchange water: 5
Washing solution container.

XL-200
Technical Specifications 5-7

Detergent: 10 liters Capacity


Reaction waste is collected into two waste cans (concentrated waste and
diluted waste) by pumps.
In built cuvette overflow protection.

5.6 Optical absorption measurement unit

Item Description

Type Multiple Wavelengths, Static Filter.

Photometric system Multi-wavelength direct measurement of light after penetration into


reaction cuvette (transmitted light).

Wavelength 8 Wavelengths: 340 nm, 405 nm, 505 nm, 546 nm, 578 nm, 600nm, 660
nm and 700 nm.

Wavelength per One or two wavelength.


chemistry

Measurement interval Total 36 points.


Every 18 seconds for 18 second cycle time.

OD range OD 0 – 3.
Light path calculated as 10 mm.

Resolution 0.0001 OD

Light source Pre-aligned Halogen lamp (12V/20W).

Detector Silicon photo-diodes.

Cell blank correction Corrected by water blank measured after cuvette washing.

5.7 Data processing

Item Description

Calibration curve K-Factor, Linear (one point, point-to-point and multipoint), Cubic Spline,
Exponential, 4P Calibration Logit-log, 5P Calibration Logit-log,
Polynomial.
Multipoint curves up to 10 points.
One point correction (using Blank) to multi-point calibration line is
provided.
Auto-dilution for nonlinear curves.

Quality control Within day as well as day-to-day X and X-R control diagram.
Mean, SD, %CV, R are calculated for the each chemistry.
QC graph based on west gard QC rules

Repeat run Execution by repeat run list or auto execution.


Auto execution according to abnormal marking or range over.
Increased/decreased volume repeat run also possible.

XL-200
5-8 Technical Specifications

Monitor function Reaction curve graphical display


Calibration curve graphical display
Operation status and Reagent Level in Bottles graphical display.
Cell Blank Monitor

Calculation between Correlation correction factor (Y = aX + b).


items Calculation by the formula defined by user.
No Limit on the Calculation Items programmed.
Each calculation item can include up to 5 chemistries.
Recalculation and saving of recalculated results possible
Test profile can be defined

Report/list format Report generation: Patient wise, Test wise, Date wise, Location wise,
Abnormal result wise, Doctor name wise, Batch wise.
Lists: Abnormal values list, Pending run list, Repeat run list.

Backup Partial backup of selective data such as Consumables, Patient, Patient


with Results, Test Parameters, Calibration, Error Log, System parameters
Is possible in the Text, XML, XLS and CSV formats.
Full Backup.

Special treatment Reagent blank correction.

Data check Reference range check by age, gender, sample type.


Panic limit check.
Reagent absorption check.
Technical limits check.
Reaction linearity check.
Reaction mixture absorbance checks.
Antigen excess/prozone check (by reaction curve analysis method).

Alarms and notices Types of alarms: Erroneous operation, mechanical malfunction of


analyzer, data processor hardware error, erroneous test results
Alarm level: Notice, temporary halt of analysis, suspension of analysis,
system stop.
Prompts on display alarms.

Diagnostic checks Mechanical movements and functional performance can be checked


through diagnostic menu. Mechanical movements and functional
performance can be checked through diagnostic menu

Password Access Rights for multiple users


Password provided to access select menus

XL-200
Technical Specifications 5-9

5.8 Accessories/Consumables

Item Description
Installation parts Sample tray, Reagent tray, Wash solution can, Waste can,
DI Water supply can.
Consumables XL WASH (Cat. No. XSYS0066), ERBA XL AutoWash AC/AL (Cat. No. XSYS0082),
Sample cup/tubes, Halogen lamp,
ISE consumables (Optional) - XL ISE Cleaning (Cat. no. XSYS0062),
XL Urine Diluent (Cat. no. XSYS0067)

5.9 Computer Specification

Item Description

Processor Intel Core i3 (or higher)

Memory RAM: 4 GB minimum

Disk Space 500 GB minimum

Display Color Touch Monitor 17” (or higher),


Aspect Ratio 4:3 or 16:9, Resolution 1152 x 864 or higher

Key Board English Standard Keyboard, USB / Wireless

Mouse USB / Wireless

Operating System Windows 10 Professional 32/64 bit English Edition


TBM OS of Windows 10 IoT 32/64-bit English

Printer Laser Jet / Desk Jet

Ports USB Ports: 6 (minimum), preferred 8 ports: Analyzer, Keyboard, Mouse,


Printer, Test-Loader Device, Data Backup (pen drive).
USB Types: USB 3.0 (minimum 4 ports), remaining above USB 2.0.
Analyzer PC to Host PC / LIS Connection [Optional]:
o 1 Serial Port OR
o 1 USB Port [through USB to Serial Converter] OR
o TCP/IP

Regional Setting Language English (US)

The minimum specification for the system is shown in the above table. However,
it is recommended to use the most powerful system available

XL-200
Part

VI
User Interface 6-2

6 User Interface
You can control the day-to-day operation of the instrument through the MultiX L s oftware. This section
describes the main features of the user interface and how to move between the various screens.

See the following sections for more details:

A first look at the user interface

Main menu layout

Screens

6.1 A first look at the user interface


When you have logged on, the Patient Entry screen is displayed.

1 Main menu
Click on any menu item to display the corresponding screens.

2 Check box
When selected, that a particular feature has been enabled.

XL-200
6-3 User Interface

3 Drop-down list
Allows the to choose one value from a list.

4 Dotted button
Click to select and enter data for that field.

5 Text box
To enter the data for that field.

6 Command buttons
Click to print, save, clear, edit and delete

7 Tests
Click to select the test.

8 Indication box
Provides help or warning messages.

9 Logout
Clic k to logout from m ultiX L

10 Shut Down
Click to turn off the application

11 Navigation button
Clic k to navigate firs t, previous , next and las t rec ords .

12 Help
Click to provide help

1 Calender button
To choose only one of a predefined set of options.

2 Crossed button
To clear the text for that field.

3 Radio button
To select the date.

4 Preview button
To preview the data before print

XL-200
User Interface 6-4

5 Print button
To print the data

6.2 Main menu layout


Main menu consists of various screen items through which you can perform a set of generally related
tasks. You can open a work screen by:

Clicking one of the w ork screen items Or

Pressing the appropriate function key (see below )

Main What can it do


menu
screen
items

This s c reen is us ed for defining s ample det ails , pat ient demographic s and
s c heduling t es t s / c alc ulat ion it ems or profiles .

This s c reen is us ed for viewing t he QC Dat a and t win plot graph. It is als o
us ed for viewing t he c alibrat ion c urve for a part ic ular t es t and for s c heduling
blank s / s t andards / c alibrat ors / c ont rols .

This s c reen is us ed for performing c alibrat ion, pat ient run, viewing reagent
level in bot t les of different t es t s and performing s ample and reagent
barc ode s c ans . It is als o us ed t o view online reac t ion c urve and IS E pac k
det ails (Opt ional).

This s c reen is us ed for viewing pat ient report s , c alc ulat ing s t at is t ic al dat a
us ing Tes t S t at is t ic s s c reen, viewing res ult s on Res ult Reprint s c reen,
V iew t he c alibrat ion of a t es t over a period of t ime on Calibrat ion Trac e,
V iew t he c urrent c alibrat ion on Calibrat ion Monit or, Log of all t he errors on
E rror Log s c reen, reac t ion c urve of t he res ult s obt ained on Reac t ion Curve
s c reen and Reagent c ons umpt ion on Ot her s c reen. This s c reen is als o us ed
for s earc hing pat ient res ult s , c alibrat ion/ c ont rol res ult s , pat ient s ,
c ons umables or t es t det ails

This s c reen is us ed for defining t es t det ails , t es t volumes & referenc e


ranges .

This s c reen is us ed for defining Reagent P os it ions , B ac k up Dat a, t o view


Offline Res ult s and rec alc ulat e t he res ult s obt ained.

This s c reen is us ed for performing Maint enanc e operat ions at t he s t art and
end of t he day

XL-200
6-5 User Interface

This s c reen is us ed only by S ervic e P ers onnel.

This s c reen is us ed for defining mis c ellaneous paramet ers lik e A rea,
Laborat ory , Doc t or’s Det ails , A naly s t Det ails et c .

This s c reen is us ed for defining s y s t em paramet ers , c arry over pairs , t es t


s equenc e, rerun flags , hos t s et t ings and t o as s ign us er right s .

6.3 Screens
This section describes the following main menu screen items in more detail:

Patients

QC/Calibration

Monitor

Reports

Tests

Utility

Maintenance

Service

Master

Settings

6.3.1 Patients

Patient Entry is used to enter the patient details like name, address, doctor referring patient, analyst,
age, gender etc can be entered using this screen. Also, the routine tests, calculation items, profiles
to be performed on the patient sample can be requested using this screen. These patient
demographics are used to generate the patient report after analysis of the sample.

This screen is divided into two sections:

One for defining information related to Sample definition and other for Patient demographics entry.

Commands buttons available for clearing the patient schedule, checking work list, mask tests and
copy tests.

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Single patient can have more than one Sample ID.

See the following links for more details:

Sample Definition Parameters

Patient Definition Parameters

Clear Schedule

Work List

Copy Tests

Mask Tests

Download Samples from LIS

CEC

6.3.1.1 Sample Definition Parameters

Parameters Description
Sample ID This field is used for assigning an alphanumeric identification number of up to
18 characters to each patient. Entry in this field is compulsory and cannot be
skipped. If the Sample ID is already entered, then the user can view the
Sample ID by clicking on the dotted button placed next to the Sample ID text
box.

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Position In case the sample is not bar-coded, the user should specify the sample
position in this text box. An assigned sample position cannot be used for
some other sample. Any sample Positions on the sample tray can be entered.
If there are more than maximum no of Sample Positions, then a different Group
No. needs to be selected.
For bar-coded samples the sample position is automatically assigned as per
the group number selected after the sample bar-code scan.
For emergency samples, any position that is vacant can be used for any group
during Patient Run.
Group This field is used to assign group numbers for various samples processed
during the day. If there are more than maximum sample positions, then the
user needs to select Group 2 and so on. The user can assign the Group
Numbers from 1 to 99.
Emergency Whether the given sample is an emergency sample or not is specified using
this tick option. To designate a sample as an emergency sample, tick in this
field and assign one of the free positions for the sample. Emergency samples
are given priority over routine samples in a run.
Barcoded The user can select whether to use sample bar-code facility or not. If the bar-
code option is set to ON in the Settings > System Parameters screen, then
the sample position fed by the user is ignored. The user has to select/deselect
the check-box for whether the sample for the particular patient is bar-coded or
not. The barcoded option can be selected to only the outer two rings of sample
positions.
During Run, changing status from non barcoded to barcoded is ignored (not
saved) for a Sample ID in progress.
Sample Type Select the sample type from the drop down list. The default options available
are: Serum, Urine, CSF, Plasma, Whole Blood and Other
Sample Select the sample volume type using the drop down list. The available options
Volume Type are Normal, Increase and Decrease. The default value is Normal. User may
select Increase or Decrease, in case the sample concentration is roughly
known. If the sample has low concentration then the user can select an
increase volume. If the sample is high concentration sample, then the user can
select decrease volume.
Container Select the sample container type from the pull down option. There are various
Type options available and one can select the container type by selecting the drop
down list. Default container type can be set from Settings > System
Parameters screen.
Samples This option enables you to enter the sample replicates for a specific patient
Replicates sample. When user entered the sample replicate value through Patient Entry,
then all the tests ordered for that particular sample, including rerun, will be
performed in the specified number of replicates. In this case, sample replicate
value defined in Test Parameter > Test Details will not be considered by the
system while processing the sample.

When sample replicates value is 1 (or left blank), then each test will be
performed as per sample replicates entered in Test Parameter > Test Details
screen.

Sample replicate value should be entered between 2 to 30. By default, this


parameter is programmed as 1.

Sample replicates will not be downloaded from LIS with


patient demographics as ASTM protocol does not facilitate it.

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Registration This field is used to enter the date at which the patient was registered in the
Date hospital.
Collection
This field is used to enter the date at which the sample was drawn.
Date
Sample Remarks about sample can be fed here using up to 50 alphanumeric
Remarks characters. Previously fed remarks can be selected by pull-down options. The
remark is printed in the patient report.
Area This is used to select the area / location from where the sample is collected.
One can select the area list by clicking on the dotted button. On clicking the
dotted button, area help screen is displayed. From the list displayed on
screen, user can select the desired area by double clicking on the particular
name. This area will be printed in Patient Report as Location. User may define
area / location from Master -> Area screen. Area details can be entered using
Area screen.

Ref Doctor

This is used to select the name of the referral doctor. Alternatively, if the admin
needs to enter the doctors’ details, then he/she can enter from master screen.
One can select the doctor’s list by clicking on the dotted button. On clicking
the dotted button, following screen is displayed. From the list displayed on
screen, user can select the doctor’s name by double clicking on the particular
name for the respective patient. Doctor details can be entered using Doctor
screen.

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Analyst This is used to enter the name of the analyst. Alternatively, if the admin needs
to enter the analysts’ details, then he/she can enter from master screen. One
can select the analyst’s list by clicking on the dotted button. On clicking the
dotted button, following screen is displayed. From the list displayed on screen,
user can select the analyst’s name by double clicking on the particular name
for the respective patient. Analyst details can be entered using Analyst screen.

6.3.1.2 Clear Schedule


This screen is used to clear the patient samples scheduled on the sample tray. Use Clear
Schedule button provided on the Patient Entry screen.

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You only need to define the sample positions in From Position and To Position text box. Valid
positions are from 1-30 and I-1 to I-9.

Clear Schedule and Position

The option will deletes the test requests scheduled for analysis and the positions for the Sample
IDs on selected positions on clicking OK button. The samples and patients are not deleted.

Delete Sample

The option will delete the samples on the selected positions along with demographics and the test
requests scheduled. Option to recalculate test results is not available for deleted patient samples.

6.3.1.3 Work List

The Work List button available on the Patient Entry screen displays the list of requested test for
a particular group number. On clicking the following screen will be displayed.

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The work list for any group can be viewed by selecting the following options All, Patients,
Calibrations or Controls.

On selecting ‘Patients’ option, only patient samples are displayed in the work list. On selecting
‘Calibration’, work list will display Blank, Standards and Calibrators programmed.

On selecting ‘Controls’, work list will display controls programmed in the respective group.

The test from the Work List screen can be masked using Mask Test(s) option.

The work list includes the following details:

Parameter Name Description

Group No. It displays the Group number that has been selected.

Sample Position It displays the Sample position assigned. For bar-coded samples, the
position is assigned after the sample barcode scan.

Sample ID It displays the Sample Id assigned to the patient.

Sample Type It indicates whether the Sample type is Serum/ Urine/ CSF/ Whole
Blood/ Other type.

Sample Vol Type It indicates whether the sample volume is Normal/ Increase/ Decrease.

Test It displays the test name.

Replicates It displays the number of repetitions that a test will undergo during run.

Sample Volume It indicates the Sample volume programmed in test parameters for that
particular test.

R1 Volume It indicates the R1 volume programmed in test parameters for that


particular test.

R2 Volume It indicates the R2 volume programmed in test parameters for that


particular test.

R1 Position It displays the position of R1 for that particular test as defined in Utility-
Rgt. Position.

R2 Position It displays the position of R2 for that particular test as defined in Utility-
Rgt. Position.

The Work List includes the details of barcoded samples too even though their positions may not
be known.
Tick the Mask Tests option to mask one or more tests from the entire group.

6.3.1.4 Copy Tests


Use this option to copy the same tests and calculated items across patient samples.

Enter the patient and sample details and schedule the tests/calculated items. Then click on the
Copy Test(s) button. Upon clicking this button, enter From and To sample positions, to which you
desire to copy test schedule. The entire range of sample positions would be assigned the same tests
and calculation items.

When the option Generate Sample ID is checked, an incremental sequential series of unique Sample

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IDs will be generated for the range of selected positions.

During run, when Copy Test(s) option is used:

Masked Test of source Sample ID will be copied as Masked Test(s).

Scheduled, Completed and In Process Test(s) of source Sample ID will be copied as


Scheduled Test.

Pending Test of source Sample ID will be copied as Scheduled Test, if required parameters
such as sample/reagent details are available. Otherwise, it will be copied as Masked Test.

While copying ISE tests from Serum Sample to Urine sample, Lithium test will be excluded; as
Lithium is not performed for Urine Samples.

Following screen illustrates an example to copy test(s) of source Sample ID (selected in Patient
Entry screen) to Sample positions 2 to 6 of Group 1, along with generation of Sample ID (unique
sequential series).

6.3.1.5 Mask Tests

Upon scheduling the tests, the user can click on the Mask Tests button to mask the tests
temporarily which should not be run immediately, but can be run in the middle of the run. The
selected tests for the selected Sample ID will be masked.

To mask the Test(s) for the (multiple) Samples. Tick the Mask Tests check box in the Patient
Entry > Work List screen and select the required test(s). This feature is useful if the reagent for
the tests are not available but would be made available during the middle of the run. In these
cases, the user can mask the tests and keep them on hold.

Once the reagents are available, then the user can unmask the selected tests from Status
Monitor > Work List screen.

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To mask the Test(s) for the entire multiple samples, select the option Mask Test(s) in the Patient
Entry > Work List screen.

6.3.1.6 Download Samples from LIS

This button is displayed on the Patient Entry screen only when the Host
Connection check-box is selected in Settings > System Parameters screen.

The Download Sample button is used to download the sample details (like patient name, age,
gender, sample type, etc) along with the test details; from the LIS for the selected samples;
irrespective of whether they are barcoded or non-barcoded samples, that are placed on analyzer’s
Sample Tray.

The test details will be automatically downloaded by clicking Sample Barcode


Scan button through Status Monitor > BARCODE SCAN or during batch before the
run starts, if option Sample Barcode Scan is selected from PRE-RUN options.

Before downloading the sample details from the LIS, make sure that you should have the following
necessary pre-requisites:

The option Host Connection in Settings > System Parameters screen should be selected.
The Host Setting screen is always enabled to view the settings.

Follow the procedure to download non-barcoded samples from the LIS:

1. Place the barcoded or non barcoded sample on the analyzer’s sample tray.

2. Go to Patient Entry screen, and define required details for the added samples.

3. Click on Download Sample button.

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User Interface 6-14

It will display a window containing all registered sample IDs with check-box option to select.

4. Now, select the required sample IDs details to be downloaded from the LIS and click
Download.

On clicking, the sample details will be downloaded from the LIS to barcoded samples and the details
are displayed in the Patient Entry screen.

If the communication between Host and LIS is not established then it should pop
up message to check connection in Host Settings screen.

6.3.1.6.1 Patient Definition Parameters

Parameters Description
Patient Name Enter patient name in the field using the keyboard. A maximum of 30
characters can be fed in this field. Alternatively, patient can be selected
using the dotted button placed next to the Patient Name. Also, if the user
desires to use the same patient with different sample ID, then he/she can
double click on the dotted button and select the patient name for a
different Sample ID. Hence one Patient can have multiple Sample IDs.
Patient ID Enter patient identity number. For example, social security number or
insurance number can be entered here for printing on Patient Reports.
Category This field is used to identify the sex of the patient. Select as Male /
Female / Child / Other. The default option is Default.

For a patient selecting the category is optional. But if


the category is not selected then the default reference
ranges will be applied. After the run is performed
patient category can be updated and on recalculation of
the results, reference ranges will be applied and hence
the H / L flags will be attached.
Age Enter the numerical age of the patient (in three digits maximum). Choose
age in Days/Months/Years using the pull down option. The patient age is
used to issue H and L flag for the corresponding age range as mentioned
in the Test Parameters (see section Reference Range). If age of a patient

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is not fed, default normal values are used to issue H and L flags.

Address 50 alphanumeric characters are allowed to enter the address of the


patient.
Patient Tel No This text-box is used to enter the contact number of the patient.
Patient Remarks Remarks about patient can be fed here using up to 50 alphanumeric
characters. Previously fed remarks can be selected by pull-down options.
These remarks are printed in the Patient Reports. .
Height This field is used to enter the height of the patient (in meters).

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

Weight This field is used to enter the weight of the patient (in kilograms).

Body Mass Index (BMI) for the patient is calculated automatically that is
used for Creatinine Clearance calculation. BMI is calculated by the
following formula:

BMI = (Weight)/(Height)2

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

Urine vol(ml/24 hrs) Use this field to define the volume of urine collected from a patient in 24-
hour duration. This is an optional parameter and is used in the calculation
item of Creatinine Clearance. This field can be ignored if user does not
want to use Creatinine Clearance calculation item.
If user wants to use Creatinine Clearance calculation item, entry in this
field is necessary and the user should feed the urine volume (in ml)
collected in 24 hours in this field.

This parameters is read only and can be entered


through CEC screen.
See section CEC for more details.

6.3.1.7 CEC
This section tell you how to schedule, clear schedule and edit CEC for a patient.

CEC option is available in the calculation item list. When you click on this, following screen is
displayed.

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When Patient Name is selected then sample Id’s will be displayed in the list for that patient only, and
if the patient name is not selected, then the entire list of sample Id’s will be displayed in the list
irrespective of the patient name. (Patient Name selection is optional). Patient ID is automatically
displayed on selecting the patient name.

Options available on the screen are:

Schedule CEC

Clear Schedule CEC

Edit

For CEC (default calculation item), user can choose any of the photometric test
whose name start with CRE. (e,g. CRE, CREA, CREAT, CRENZ)

6.3.1.7.1 Schedule CEC

This section tell you how to schedule CEC for a patient.

Follow this procedure to schedule CEC:

1. Select Schedule CEC option.

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Select the Sample ID – Urine from the list of sample id with sample type as urine for the
patient selected or all sample id’s.

5. Enter the Height in meters.

6. Enter the Weight in kg.

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7. Enter the Urine Volume (ml/24 hrs).

8. Click on SAVE button.

On clicking, the Height, Weight and Urine Volume will be updated for both the Sample ID
and the message will be displayed indicating that CEC is schedule successfully.

In case, user changes CEC (Test) definintion after scheduling CEC for the patient
sample, then CEC result will Not be Applicable for existing CEC schedules. A
pop-up appears as shown below;

6.3.1.7.2 Clear Schedule CEC

This section tell you how to clear CEC schedule for a patient.

Follow this procedure to clear schedule:

1. Select Clear Schedule CEC option.

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Sample ID – Urine will automatically be displayed according to the Serum / Plasma Sample
Id selection.

5. Height will be displayed according to the Patient Name / Sample Id selection.

6. Weight will be displayed according to the Patient Name / Sample Id selection.

7. Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection.

8. Click on Delete button.

Message will be displayed indicating that CEC schedule is cleared successfully.

6.3.1.7.3 Edit

This section tell you how to edit CEC for a patient.

Follow this procedure to clear schedule:

1. Select Edit option.

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User Interface 6-18

2. Click on Show Sample ID button to view and select the sample id from the list.

3. Select the Sample ID – Serum / Plasma from the list of sample id with sample type as
serum / plasma for the patient selected or all sample id’s.

4. Sample ID – Urine will automatically be displayed according to the Serum / Plasma Sample
Id selection.

5. Height will be displayed according to the Patient Name / Sample Id selection. The height
displayed can be changed.

6. Weight will be displayed according to the Patient Name / Sample Id selection. The weight
displayed can be changed.

7. Urine Volume (ml/24 hrs) will be displayed according to the Patient Name / Sample Id
selection. The Urine Volume displayed can be changed.

8. Click on SAVE button.

Message will be displayed indicating that CEC schedule is cleared successfully.

6.3.2 QC/Calibration
QC/Calibration is used to perform the following operations:

Scheduling consumables

Viewing calibration curve and perform curve related operations

Monitoring of the performance of the analyzer

Twin plot graph

Viewing control data and graph for two different controls

See the following screen.

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6.3.2.1 Schedule QC/Calibration


Schedule QC/Calibration screen is used to schedule consumables (Blank, Standards, Calibrators,
and Controls).

See the following procedure for scheduling consumable in more details:

Scheduling Standard

Scheduling Controls

Scheduling Blank

Scheduling Calibrators

6.3.2.1.1 Scheduling Standard

Use the following procedure for scheduling:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position from the Position drop-down list. This drop-down will also display
the last scheduled consumable name at respective position. This consumable name is
retained for a position till a patient sample is defined on that position.

3. Select appropriate container from the Container Type drop down list.

4. Select consumable type as 'Standards' from the Consumable Type drop down list.

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User Interface 6-20

5. Select appropriate consumable from the Consumable drop down list.

6. Select the required Lot No. of the selected consumable. The last defined lot number appears
as selected, by default.

On selecting the lot number, a grid with the list of tests for the selected consumable appears
on the right side of the screen, where in option of auto dilution and dilution ratio can be
selected for non-linear chemistries.

7. On selecting AutoDil and DilRatio, click OK.

Depending on the concentration and the DilRatio (dilution ratio) selected for the test, the
number of serial dilutions possible will be displayed in another grid as shown in the following
figure.

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6-21 User Interface

Further dilution numbers can be selected using this grid.

If the dilution ratio is not selected then default dilution ratio will be applied to
the test. The default dilution ratio is 2.

8. Click OK.

On clicking, the details will be added in the required position as shown in the following figure.

.
Auto-dilution is possible for non-linear curves.

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Auto-dilution is not possible for the curve types K-factor and Linear. The gray
background color in the column AutoDil indicates that auto-dilution is not
possible for the respective test.
Auto-dilution is not available for selection if option ‘Apply Normal Dilution
Ratio of Sample’ for a test is selected in Test Parameter > Test Volume.
If Auto dilution is scheduled for a test then Normal Dilution Ratio cannot be
applied for that test. In this case, you have to clear the auto dilution schedule.

9. Click on SCHEDULE button.

On clicking the SCHEDULE button, the standards will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards /
Calibrators are not scheduled.

While performing the Blank, Standards, Calibrators and Controls that are scheduled, the
sample and reagent volumes defined (in Test Parameter > Test Volume) for Sample Type
Serum is used. This is indicated by Serum in the column Sample Type.
To clear the schedule CLEAR POSITIONS button can be clicked. On clicking, following
screen is displayed to either clear selected positions or all the positions.

Clear position button does not clear the sample positions. Only scheduled
Blank, Standards, Calibrators and Controls will be cleared.

Hence, either a particular position is selected or CLEAR ALL option is checked.

6.3.2.1.2 Scheduling Control

Use the following procedure for scheduling the controls:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position. If the position is occupied, then the user can view it in the grid
placed on the bottom side of the screen. This drop-down will also display the last scheduled
consumable name at respective position. This consumable name is retained for a position till a
patient sample is defined on that position.

3. Select appropriate container type from the Container Type drop-down list.

4. Select Controls from the Consumable Type drop down list.

5. Select appropriate control from the Consumable drop-down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

On selecting the lot number, grid on the right side of the screen displays the available tests
for the selected consumable for running the QC and test Profiles grid with available
profiles.Sample type (Serum/Urine) will get displayed accordingly in sample type with
respect to selected control for the test. See figure below.

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6-23 User Interface

You can create your own profile through Profiles screen.

7. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), and then click on the OK.

On clicking, the details will be added in the required positions as shown in the following
figure.

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User Interface 6-24

8. Click on SCHEDULE.

On clicking, control will be scheduled.

9. To clear the schedule, click CLEAR POSITIONS button.

If a position was used during earlier calibration run, then consumable name
is also displayed along with the position number in ‘Position’ drop down list,
till the new patient sample is defined on that position. See figure as shown
below.

These positions can be reused by re-selecting it for a new schedule.

6.3.2.1.3 Scheduling Blank

Use the following procedure for scheduling blanks:

1. Select the group number on which the calibration and QC run needs to be performed using

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Group drop-down list.

2. Select a desired position. User can view the occupied sample positions in the grid placed on
the lower half of the screen.

3. Select the appropriate container type from the Container Type drop-down list.

4. Select Blank from the Consumable Type drop-down list.

5. Select appropriate blank from the Consumable drop down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

On selecting the lot number, grid on the right side of the screen displays the available tests
for the selected consumable for running the QC and test Profiles grid with available profiles.
See figure below.

The screen consists of three column:

Tests

Selective

Curve Type

Tests: Tick the check-box to select (schedule) the test.

Selective: Tick this check-box to schedule Selective Calibration (perform only blank to

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User Interface 6-26

derive the calibration curve) for the test.

Curve Type: It displays the curve type for the test.

The check-box with Gray color in the Selective column indicates that the
test may not be Calibrated or Already Scheduled or Unsuccessfully
Calibrated. In such case, selective calibration option is not available.

Schedule Full calibration, if not already scheduled in any group.

7. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), click on OK.

On clicking, the test(s) will be added in the selected positions

Test(s) scheduled with Selective Calibration are marked with Asterisk (*)

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symbol under column Pos.

7. Once the blank are defined, click on SCHEDULE.

On clicking, the blank will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards/
Calibrators are not scheduled.

8. To clear the schedule, click on CLEAR POSITIONS button.

6.3.2.1.4 Scheduling Calibrator

Use the following procedure for scheduling:

1. Select the group number on which the calibration and QC run needs to be performed using
Group drop-down list.

2. Select a desired position from the Position drop-down list. This drop-down will also display
the last scheduled consumable name at respective position. This consumable name is
retained for a position till a patient sample is defined on that position.

3. Select appropriate container from the Container Type drop down list.

4. Select appropriate consumable type, Calibrator, from the Consumable Type drop down list.

5. Select appropriate consumable from the Consumable drop down list.

6. Select the required Lot No of the selected consumable name. The last defined lot number
appears as selected, by default.

7. On selecting the lot number, a grid with the list of tests for the selected consumable appears
on the right side of the screen, where in option of auto dilution and dilution ratio can be
selected for non-linear chemistries. See figure below.

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User Interface 6-28

8. Select the required test (tick manually against each required test or click on Profile to select
multiple tests under the profile), Select auto dilution and dilution ratio, as applicable and then
click OK.
You can create your own profile through Profiles /Calc > Profiles.

9. Following figure shows that tests are selected through available profile

10.On clicking OK, the tests will be added in the selected positions.

11.Click on SCHEDULE.

12.On clicking, the Calibrator will be scheduled.

The MultiXL will prompt a message if the required Blank and Standards/

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Calibrators are not scheduled.

6.3.2.2 Calibration
Calibration screen allows to view calibration curve and to perform curve related operations. Lot
number and concentration for that test are defined in the Consumables screen.

Test Revision (if available) will be displayed on the screen in red color.

This Revision shall be printed on the Calibration Report as well, as shown below;

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User Interface 6-30

After the calibration run is completed, absorbance values obtained by the analyzer are updated in
the Calibration screen along with the K-Factor. The date and time of calibration is also updated.

For any 2-Point chemistry, if the concentration obtained by the calibration curve
is negative (below zero), then the output test result will be in multiple of 0.1 (or
zero), based on decimal places set for the test.

One of the last five calibration curves can also be selected for use in result calculations.

Use previous or next calibration can be viewed using navigation buttons.

For using the calibration on the screen, use Set Latest Calibration button. On clicking, a warning
message will be displayed for user.

In order to view the calibration details for a test in use, the user needs to select the test from the
grid.

Before using Set Latest Calibration, make sure that calibration is performed with
the current Test Parameters. Result may not be correct, in case parameters were
different.

To print the calibration table along with the calibration graph, click on PRINT button.

If there has been some error during calibration (like reagent absent or
calibrator absent), the calibration data for which reagent, blank and calibrator
was present is updated. However, Unsuccessful Calibration message will be
displayed.

Normally calibration requires 3 replicates of blank and 3 replicates of


calibrator for successful calibration. The calibration will be successful; if there

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is at least one replicate of blank and one replicate of calibrator are processed
successfully.

If at least one replicate of blank measurement is available without RgtAbsMin/


Max flag or any instrument related flag, then calibration will get proceed as
successful and calculate the result.

This table describes each parameters on the screen:

Parameters Description
Test It displays the test name.
Last
Calibration It displays the date on which the calibration of the test was performed lastly.
Date
Curve Type It shows the curve type selected for the test in Test Parameters > Test Details
screen.
Calib Expiry It allows the user to enter the Calibration Expiry Limit for that test in days. This limit
Limit is a decremented counter that commences after calibration for that test is done. The
Test, for which the calibration is expired, is highlighted with Pink color in the Patient
Entry screen.
Acceptable For Linear curves, Use this text-box to enter the acceptable limit allowable for
Limit % deviation of Factor between 2 calibrations. Default value is 15%. The user can feed
any value between 0% to 20% and is expressed in terms of percentage. During run,
when the calibration factor differs by the specified acceptable limits with respect to
the earlier factor, system will notify user about Calibration out of range for the test.
However, this new calibration will still be considered as successful.
The acceptable limit input text box will be disabled for curve
types K-Factor and Non-Linear.
Acceptable limit input is accessible only if the Calibration for the
test with linear curve is performed once successfully.
When the value is set to 0 (zero), the comparison of the factors is not done. The
comparison is made on basis of the factor obtained. The new factor obtained is
compared with the old one and based on the acceptance limit entered; the new
calibration details are updated. If the value falls outside the acceptable limits, then
the old calibration details are kept and the new details are updated with message
Factor out of Range. This text box is applicable only for Linear curve types.
Calibration It displays the date on which the calibration, currently displayed on screen, for that
Date test was performed. The display changes if previous calibration is selected.
K-Factor This parameter will be displayed only when the curve type for the test is selected as
K-factor in Test Parameter > Test Details. It is used to enter the known factor for the
required test. The value should be non-zero number between -99999.99 to 99999.99.
R1/R2 Lot- It displays the Reagent Manufacturing Lot Number along with barcoded lot No if
Bottle No available (system pack scanning) in Reagent Position used for calibrating that test.
If the test has only one reagent, then only R1 Lot-Bottle No will be displayed.
Similarly, if the test has two reagents, then R1 Lot Bottle No, R2 Lot Bottle No, text-
box will be displayed.
On Tick this check box to view only successful lot calibrations .
Successful Un tick this check box to view all calibration.(Current, Lot, Bottle, Unsuccessful
Calibration Calibrations)
Use Prev and Next button to view.

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This table describes each column on the grid:

Parameters Description
Pos It displays the Calibrator, Standard or Blank position; till the position is not utilized
for scheduling any other sample.
Consumable It displays the consumable name (Blank, Standard, or Calibrator) used for
calibrating that test.
Conc It displays the concentration of the blank or the calibrator used.
Abs This column indicates the absorbance values that are automatically obtained by the
analyzer after the calibration is carried out.
Lot No. It displays the Lot Number of the consumable used for Calibration of that test.
Factor It displays the Calibration Factor obtained for the selected test

See the available buttons and their functionality:

Set Latest Calibration: Use Prev and Next buttons on the screen to view the previous or next
calibration record, and then select successful calibration which should be used for patient result
calculation. Click on Set Latest Calibration button to set the selected calibration and use the same
for calculating results.

Copy Calibration: This button is used to manually copy the calibration details across test(s) with
same assay type and specific curve type (either both liner either both linear or both non-linear
requiring same number of calibrators); sharing the same Reagents.

For Automatic Copy Calibration, you must activate the Automatic Copy
Calibration option from the Settings > System Parameters screen.

Selective Calibration: Selective calibration, also known as One point to Multipoint Calibration or
Normalization of Calibration Curve is used when a user wants to use only a reagent blank for
calibration. It is applicable for all curves except K-factor. The user can schedule and perform this type
of calibration for individual chemistries.

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On clicking this button, two options are available under Calibration Type for the selected test:

Full: This option is the default selection through which you can schedules the entire
calibration set again.

Selective: This option is used to select blank available and then it uses the slope method to
correct the other factors.

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Repeat Calibrators: This button is displayed for the non-linear test on which the last calibration is
performed within last 24 hours. Using this button, errors of point in a non-linear calibration graph, can
be corrected by repeating the single/multiple calibrators, instead of repeating the entire calibration.
For example, see the following figure.

On clicking this button, list of calibrators processed during calibration will be displayed.

Select the appropriate calibrator(s) to be repeated by ticking the check-box at the respective row and
click SCHEDULE button. One or multiple calibrator(s) used to derive the curve can be selected to
repeat.

Schedule of such calibrators will be displayed with Asterisk (*) symbol next to test in QC/Calibration
> Schedule QC/Calibration screen. Asterisk (*) symbol indicates selective calibration with Blank/
Repeat calibrator.

This button is not available for the test whose curve type is linear or k-factor and
for non linear test more than 24 hours old.

6.3.2.3 QC Data
The QC (Quality Control) screen is used for day-to-day monitoring of the performance of the analyzer.

It allows you to monitor the following:

Accuracy of the analysis (i.e. whether the values obtained are correct)

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Precision (i.e. the reproducibility – whether the same values are obtained when the sample is
analyzed repeatedly)

The QC Data is useful for viewing the QC Results in Graphical format. QC Rules implementation has
been on QC Results in the QC Data and is marked with a respective color to indicate which rule has
been violated for that test.

Also, for each QC results you can:

Enter remarks

Exclude selected QC points permanently

View QC graph with new laboratory mean

The user should either rerun the controls again or recalibrate the test and run the controls.

To open the screen, go to QC/Calibration > QC Data screen. The following screen is displayed as
shown below:

Following are the steps to view the results and chart:

1. Select Date From and Date To. The user can select the same date for viewing the daily QC or
select a range for viewing the Monthly QC.

2. To select the test, click on dotted button near the Test text-box, a small window will open up
through which the test can be selected.

3. Select the control level using dotted button near Control text-box and hence control name for
which results and graph should be displayed. If the selected Date From and Date To are
same, all the control results can be seen. But if the user has selected Date From and Date To

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different, then only one control results can be seen at a time.

Lock button is provided to keep the particular level of control constant.

4. Lot number for a control can be selected from the Lot No. drop-down list.

5. Once the above selection is done, click on DATA button to view the results for the selection in
the result grids.

6. Batch No. will be displayed for selection, if the date range selected is same. See the following
figure.

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If the date range selected is from “x” period to “y” period (see Figure A), then,

X-bar Calculation grid signifies the following:


Level: Displays the test control levels.
N: Number of days the control run is performed.
Avg: Average of the test result values over the period specified.
SD: Standard Deviation for specified period.
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum day’s average (over specified period).

R - Calculation grid signifies the following:


Level: Displays the test control levels.
N: Number of days the control run is performed in replicates.
Avg: Average of range over the period specified.
SD: Standard Deviation for specified period.
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum range value over specified period.

If a single date is selected (see Figure B ), then the X-bar Calculation grid signifies the
following:
Level: Displays the test control levels.
N: Number of replicates the control is run during that day.
Avg: Average of the test result values on that day.
SD: Standard Deviation for that day
%CV: Coefficient of Variation calculated from Mean and SD.
R: Difference between maximum and minimum result (if replicates are done)

If a single date is selected, then R Calculation is not applicable.

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In the QC results, Result column will be highlighted in different colors, if any of the default
QC rules stated below is violated. See the following figure for example.

The above six rules are given different colors to highlight the result or the point on the graph when the
corresponding rule is violated. To see the QC rules, just place the pointer over any of the item, a pop
message will be displayed with description.

The user needs to check the control result after the control run is completed and hence take
corrective action whether to continue with patient samples or not. Or else perform calibration again
and re-run the controls to check if the results are proper.

Buttons for quick selection

: This button is used, if you want to apply user-selected QC rules in


results. By default all rules are ticked. Un-tick rules that are not required and click this
button. For example, see the following data after clicking this button.

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: This button is used for applying filter for QC results to be excluded,


based on deviation flag selection. On clicking this button, all QC results having selected
deviation will be ticked which can be excluded using Excluded QC Results button. For
example, see the following data after clicking this button.

Entering remarks for QC points

Click on the remark icon to enter user remarks, such as, reasons or corrective action taken for
outlier QC results (if required). See the figure as shown below.

Lab mean calculation is also available for ISE controls results.

Excluding QC points permanently and view proposed graph with lab mean

QC points can be excluded by using Exclude QC Results and Exclude and Apply Lab Mean, as
per user requirement.
To do this, select the required QC points to be excluded, and click on the button, as appropriate.

See the functionality of buttons used for this purpose:

: This button is used to view the data after excluding the

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selected QC results. After confirmation it will exclude user selected QC points


permanently.

: This button is used to see the preview of graph with new


proposed lab mean excluding user selected QC points.

In the graph, small rounded circles indicate excluded QC points.

: This button is used to view the data after excluding


selected QC results after confirmation, and the proposed lab mean is applied to QC results
for the selected date range and future dates till user calculates new lab mean. Proposed lab
mean is calculated according to the user required QC points and displayed in lower left
corner of the screen.

New Standard Deviation (SD) will be only applied to future QC results


based on user choice. A confirmation message will be displayed as
shown below.

Once lab mean is calculated for the selected control results, it can not
be recalculated. Those results are disabled and indicated with gray
background.

When the lab mean is applied, the new lab mean will be displayed on top right of the
screen with date on which it is applied. See the following figure.

Use GRAPH button to view graph with new lab mean or manufacturer mean, as
appropriate.

In Result Reprint screen, data is displayed with respect to new lab


mean and SD (once calculated). Excluded QC results are indicated
with “~ ” symbol with gray color background for Control data.

Select option QC Rules in Graph to view the QC rules in graph.

Above buttons (Exclude QC Results, Proposed Graph and Exclude


Apply Lab Mean) will be disabled, if the available non excluded QC
points are less than the value entered in option Min QC Result for Lab
Mean in Settings > System Parameters.

Other buttons available on the screen

EXPORT: User can click on EXPORT button to export the data to an excel sheet.

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PRINT: User can click on PRINT button to print the data.

6.3.2.4 Twin Plot


This feature of Quality Control helps the user to compare the trend in the values of the different level
of controls for any chemistry.

It provides a running check on the linearity of instruments and integrity of calibration.

For Twin Plot, two levels of control samples with different lot numbers are required. Period (date
range) and Test name needs to be selected before viewing the twin plot.

See the following procedure to view the results and chart:

1. Select Date From and Date To: The user can select the same date for viewing the daily
graph or select a range for viewing the monthly graph.

2. To select test, click on dotted button near the Test text box, a small window will open up
through which the test can be selected.

3. Select Control for X and also for Y and then click on Show Lot.

4. Select Lot No. for that Control X and also for Y from the list displayed.

5. On selecting Lot no, the following data will be displayed:

a. Level – Level of the control selected.

b. Target Mean – Target Mean of the selected lot.

c. Target SD – Target SD of the selected lot.

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d. N – No of Days is date range is selected or no of replicates if single date is selected.

e. Mean – Mean of Daily averages if date range is selected Or Mean of all the replicates for
the single date selected.

f. SD – Standard Deviation of Daily averages if date range is selected Or Standard Deviation


of all the replicates for the single date selected.

g. CV - Coefficient of Variation calculated from Mean and SD.

h. Range - Range of Daily averages if date range is selected Or Range of all the replicates for
the single date selected.

7. Once the above selection is done, click on DATA button to view the results for both the
controls selected.

If same lot and same control is selected for control X and control Y then a
warning message "Same Control Lot selected" is displayed.

8. Click on GRAPH to view the graph for both the controls selected. The daily averages for
Control Y are plotted (on the Y-axis) against the daily averages for Control X (on the X-axis).

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9. Un-check the Show Date check box, if you do not want to display the date on the marked
points.

10.Use EXPORT to export the data to an excel sheet.

11.Use PRINT to print the data and graph.

6.3.2.5 QC Graph
This screen is used to view control data and graph for two different controls. To view the control data,
select the required date range and other details, and then click DATA.

Click GRAPH to view data in a graphical format.

Use EXPORT to export the data to an excel sheet.

Use PRINT to print the graph.

Lock button is provided to keep the particulate level of control constant.

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6.3.3 Monitor
Status Monitor shows you the status of samples during batch run, reagent level in bottles, reaction
curve, and position of the scanned reagents and samples. Much of the information is presented
graphically.

The Status Monitor screen has four main options, each of which shows the state of a particular part
of the system.

See the following section for more details:

SAMPLE TRAY

REAGENT TRAY

REACTION CURVE

BARCODE SCAN

Options and command buttons available on the screen:

Pre-Run Options

Work List

Add Sample and Reagent (Barcoded)

ISE Pack (Optional)

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Refresh Position

Scan Pack

In Status Messages > Select test in Result grid > window popped up to display
date and time of latest calibration used for that test.

When starting the batch RUN, if dome is open, then pre run activities will not be
started and error message with alarm beep will be displayed in error display
grid.

Ensure to close dome properly before proceeding.

There are two levels of dome opening, at Level 1 opening there will be warning
message and alarm whereas at Level 2 opening sampling will be stopped
immediately.

During Maintenance activity this screen is disabled and can be accessed by the
user only upon its completion.

When click on button, a card expiry warning message will get displayed
with expiry details of open test counts if card is expiring soon. Click to close
the warning message.

During pre-run activities, if user is on some other screen (e.g. doing patient entry)
then at the completion of pre-run activities, screen may get switched to 'Monitor'
screen for some time to get user's attention but it will automatically come back
to earlier screen so that user can complete remaining activities.

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6.3.3.1 Sample Tray


When you click on the Status Monitor, by default SAMPLE TRAY screen is displayed.

The SAMPLE TRAY screen gives a graphical representation of the occupied samples positions on
the sample tray assembly. The tube positions are color-coded so that you can easily check the
status of the samples when they are scheduled for batch run.

6.3.3.1.1 Sample Status Indicators

When the batch run is started, each samples will go through number of states will be represented in
the following color codes:

Color Code Status Description


When a sample position has scheduled test(s) then the circle with
Scheduled
respective sample position is indicated with TURQUOISE COLOR.
For a sample position, when sampling for test has been completed but the
In Process measurement is in progress and results are yet to be reported, then the
circle is indicated with YELLOW COLOR.
For a sample position, when one or more test(s) are pending due to
Sample/Reagent/Diluent absent or occurrence of VOD error; then the circle
Pending
is indicated with ROSE COLOR. Pending test(s) on such sample positions
can be re-scheduled either during run or at the start of the run.
When results of all the tests scheduled for a sample have been reported
Completed and no test results are pending, then the circle is indicated with GREEN
COLOR.

Sample tray also shows the current RCT and RGT temperature in the top right position on the

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screen. If the RCT and RGT temperature is within range as specified System Parameters, the
temperature is highlighted in green background color. When the temperature falls out of the range,
then it is highlighted in red color background.

6.3.3.2 Reagent Tray


When you click on the Reagent Tray, the following screen is displayed.

The Reagent Tray will displays the the updated volume present inside the bottles, after reagent
barcode scan and reagent level scan during run. Also, you can scan the volume of reagent bottles
manually, and view the updated details in this screen. Use Volume Scan button to scan the reagent
bottles.

If you place the pointer over any of the bottle, it displays the Consumable Name, Bottle Type,
available volume in ml, Reagent Name and the number of possible tests can be performed using #
sign (only when run is not in progress).

After the reagent barcode scan and reagent level scan the status will be represented in the following
color codes:

Color
Status Description
Code
If the level in the reagent bottle is defined, then it is indicated with BLUE
Normal
COLOR.
If the level in the reagent bottle is below threshold level i.e. a specific % of the
bottle capacity, then it is indicated with YELLOW COLOR. You can define your
Low
own threshold level for reagent bottle in System Parameters screen. See
section System Parameters for more details.
Empty If the reagent bottle is empty, then it is indicated with WHITE COLOR.

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If the reagent position is free (reagent not defined), then it is indicated with
Vacant
GRAY COLOR.
Discard If the reagent position is discarded, then it is indicated with DARK ORANGE
ed COLOR
If the reagent at a particular position has crossed expiry date, then it is
Expired
indicated with RED COLOR.

Color codes used for showing the bottle caps:

Color Code Description


If the diluent is assigned at a position on the reagent tray, then the it is indicated with
CYAN COLOR (Bluish shade of green).
If wash solution is assigned at a position on the reagent tray, then it is indicated with
BLUE COLOR.
If reagent is assigned at a position on the reagent tray, then it is indicated with
BROWN COLOR

6.3.3.2.1 Volume Scan

This button is used for scanning the reagent volume before scheduling a run. On clicking this button,
the probes move to all positions in the reagent tray and the reagent level status is updated and
displayed on the REAGENT TRAY screen.

Volume Scan button will scan all the reagent bottles present on both tray (before scheduling a run).
On clicking this button, the probes move to all positions in the reagent tray and the status will be
displayed graphically on the Reagent Tray screen.

After reagent scan, reagent volume details will be updated in Reagent Position screen.

You can use Stop to stop the volume scan.

6.3.3.3 Reaction Curve


Reaction Curve option is used to monitor the online reaction curve of a test, during run.

To do this, click Reaction Curve button and double click on a required test in the Cycle Map grid in
the right-most corner of the screen. On clicking, the Reaction Curve (till “x” cycles) will be displayed.
The pink arrow indicates the measurement points used for calculating the result.

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When the run is completed, the final tests result will be displayed in the result grid that is located on
the right bottom corner of the screen. The final reaction curve will be generated and can be viewed in
Reports > Reaction Curve screen. To view the curve number for the particular test, double click on
the result. On clicking, a small test details box will be displayed, which contains all the information
about the test with curve number.

6.3.3.4 Barcode Scan


Using this button, barcoded sample and reagent bottles can be scanned.

Barcode scan of the samples and reagents is performed prior to start of the run, if the option
Reagent and Sample is selected from the Pre-run Options.

The Barcode Scan button will be disabled if the option Barcode Reader option
is unchecked from the System Parameters screen.

To scan the barcode, click on the appropriate button:

Sample Barcode Scan

Using this button, you can scan the barcoded sample bottles placed on the sample tray (offline).

When you click on Sample Barcode Scan button, all the barcoded sample tubes placed on the
sample tray will be scanned and the details will be updated on the screen.

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During this process, the sample tray will be scanned for barcoded samples. After scan is over, the
sample details (like Sample ID and Position) will be updated and displayed in the following
screens:

Patient Entry

Status Monitor > SAMPLE TRAY

Status Monitor > Barcode Scan

On completing sample barcode scan, the tests scheduled on the LIS will be automatically
downloaded and applied to the appropriate samples if the communication between analyzer and
Host computer is ON.

Barcode scan of the samples will be performed prior to start of the run, if the option Sample is
selected from the PRE-RUN OPT.

The Sample Barcode Scan button will be disabled if the option Sample
Barcode is unchecked in Settings > System Parameters screen.

Sample tubes are always scanned for barcode.

Reagent Barcode Scan

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User Interface 6-52

Using this button, you can scan the barcoded reagent bottles placed on the reagent tray.

When you click Reagent Barcode Scan button, all the barcoded reagent bottles placed on the
reagent tray will be scanned and the details will be updated on the screen. Details like reagent
name, lot number, expiry date, and reagent position number.

To perform reagent bottles scan, place the reagent bottles on the tray,and click Reagent
Barcode Scan button.

After the scan, the available reagents on the selected tray number will be scanned and the
barcode id will be displayed on the screen. Reagent bottles which are not registered by Scan
Pack , then respective reagent bottle position will be displayed with barcode number along with
unknown pack details as shown in below screen See the following figure.

After Reagent Barcode Scan, Reagent Position marked with Transfer to Tube will be retained
across the batch till user either manually modifies the position or scans bar-coded Reagent bottle
on that position.
In case, barcoded Bottle is scanned on position marked as Transfer to Tube then consider
barcoded Reagent Bottle on the respective position

Column S.N. represents the Position number in the Tray.

Column Reagent Barcode generally shows the barcode number read from bottle.

In some cases, instead of barcode number, following content may be displayed in this
column.

“Checksum Mismatch”: When the checksum digit does not match the calculated
checksum of the bar-code digits.

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“Unknown-barcode”: When the digits read are not as per required format or less than
18 digits are read.

“RGT Code Unknown“: When the Reagent Code is not found in the list of Reagents in
Consumables screen.

“-“: Reagent position is manually defined through Utility > Reagent Position screen.

Reagent(s), their position, Lot number and Expiry date is registered in the system for the
barcoded bottles.

Expiry date is not applicable for barcoded system solutions (for


diluents and wash). They are treated as system solution without
expiry.

Reagent is identified from the Reagent code mentioned in the barcode pattern and matching
this Reagent Code with the Reagent Code mentioned in the list of reagents in the
Consumables screen.

This updated information is available in the Utility > Reagent Position screen.

Lot number is added in the list of Reagent Lots in Consumables screen.

The Reagent Barcode Scan button will be disabled if the option Reagent
Barcode is unchecked in Settings > System Parameters screen.

Reagent barcode scan is mandatory however, if the Reagent Barcode option


is de-selected (un-ticked) from the Settings > System Parameters screen, then
user can proceed with earlier scanned barcoded reagent bottles.

Reagent bottles are always scanned for barcode.

Re Scan
On using this option, the system application will prompt user for a re-scan of unidentified / unread
barcode at empty positions on the reagent tray.

Re Scan process is carried out only after the default barcode scan is completed.

User can choose to re-scan barcode or he may skip and continue with further activities.

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6.3.3.5 Pre-Run Options


Pre-run Options is available on the Status Monitor. All option under this will be performed when the
run is started. The Pre-Run options selected by the user is memorized and displayed as selection,
which can further be changed. The following options are available.

See the following pre-run options in more details:

Auto Rerun

This option is used for automatic re-sending of patient samples on flags. When this option is
selected, patient samples after sample processing will be automatically re-sent for the sample
run; in case the results are with specific flags.

Automatic Rerun of patient sample is performed if:

Auto Rerun option for that test is selected in Test Details screen.

Prozone Limits, Technical Limits, Panic Limits and Reaction Absorbance Limit should be
checked in Test Details screen for the respective test.

Flags selected in Rerun Flags screen for which rerun schedule has to be sent.

Disk Change

This option is used if you want to change the current Sample Disk (or Sample tray, defined as
Group in Patient Entry screen) with the new disk during the same batch run.

On completion of sampling from the current Sample disc in progress, the message will be
displayed for loading the new sample disc, as follows.

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Remove the current sample disc and load the new sample disc.

To proceed with the sampling from newly loaded sample disc and continue batch run.

a. Select the appropriate group number from the SELECT DISK NO drop-down list. This group
number represents the group of samples loaded on the newly replaced sample disc.

b. Use SAMPLE BARCODE SCAN option to scan the (newly installed) sample disk, before
proceeding with the sampling.

c. Click LOADED to proceed with run.

Auto-Rerun of patient samples will not be performed if Disk Change option


is selected.

Auto Resch (auto reschedule)

When this option is selected, any tests which are moved into pending list (due to reagent absent/
VOD) will be automatically rescheduled if the corresponding reagents are available on the reagent
tray.

If the corresponding reagent is not available on the tray, you need to load non-barcoded Reagent
Bottles as follows.

Keep the reagent bottle on the tray first and then click Refresh Position button, select position(s)
where you have kept the reagent bottles and then click on OK button. Refer section Refresh
Positions during run for more details.

For loading Barcoded Reagent Bottles, refer Add Sample and Reagent (Barcoded) for details.

Auto reschedule of pending tests will be performed only after completing


the existing schedule.

Test will not be auto rescheduled when sample is not available in Sample
Tray i.e. either Sample absent / VOD is reported or position is cleared.

On the Refresh Position screen, note ‘Pending Test Will be Auto


Rescheduled’ will be displayed on if Auto Resch option in Status Monitor
is selected.

Barcode Scan

On checking this option, all samples and reagents that are placed on the Sample Tray and
Reagent Tray will be scanned for barcode before starting the run. Two options are available:

Reagent

On checking this option, the barcoded reagents (R1, R2) that are placed on Reagent Tray will
be scanned for the barcode. After scan is over the reagent details (like Reagent name, lot
number, expiry date, and reagent position number) will be updated and displayed in the
following screens.

Status Monitor > REAGENT TRAY

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Status Monitor > BARCODE SCAN

Utility > Reagent Position

Reagent bottles are always scanned for barcode.

Sample

On checking this option, all samples that are placed on the Sample Tray will be scanned for
the barcode. After scan is over, the sample details (Sample ID and Position) will be updated
and displayed in the following screens:

Status Monitor > SAMPLE TRAY

Status Monitor > BARCODE SCAN

Patient Entry

When the Host communication (between analyzer PC and Host computer) is ON; on
completing sample barcode scan, the tests that are schedule on the LIS will be automatically
downloaded and applied to the appropriate samples.

The sample tray will be scanned during Sample Barcode scan and the Sample ID and Position
number will be updated in the Patient Entry screen. The application will then query LIS for the
details of these barcoded Sample ID. Patient demographic and the Test schedules are
downloaded from LIS and can be viewed in Patient Entry screen. The tests scheduled for the
samples will be performed on the analyzer and results will be sent back to LIS.

Reagent Level Scan

This option is used for scanning the volume of the reagent present inside the reagent bottles
before starting the run. It is available in the Status monitor > PRE-RUN OPT.

If the option is checked before the run, then when the run starts, all the reagents positions will be
scanned for reagent volume and the status will displayed on REAGENT TRAY screen and Utility
> Reagent Position screen.

Two options are available for scanning:

Selective

Selective: This option is used for scanning the Reagent volume for only those reagents,
which are defined and required by the samples in current batch.

In this window, by default, the reagents for the scheduled tests and all consumables
loaded in that batch run will be displayed as selected. . If user modified the selection, then
those selections will be memorized and displayed next time.

On clicking the Select Scheduled button, the user modified selections will be
automatically cleared and only those reagents which are scheduled for that batch run will

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be displayed.

The Diluents & Wash solution positions are always scanned, if defined. It
will not be displayed for selection.

If no tests are selected then MultiXL will only scan volume at positions
where Wash solutions, Serum Diluents and Urine ISE Diluents are
defined.
After the volume scan, if the volume of wash solution and/or diluents in
the reagent bottles is less than 10 ml, then the low volume message will
be displayed in the error message grid of Status Monitor. For example.

"Special diluent is Low(Less than 10ml)”


"Wash solution is Low(Less than 10ml)”

In case of ISE tests, if ISE urine diluent is less than 10 ml, then it will
displays the following message “ISE Urine Diluent Low (Less Than 10
ml)”with the following options:

Click on Yes button to proceed with batch Run with ISE


Click on No button to proceed with batch Run without ISE
Click on Cancel button to stop the batch Run

All

All: This option is used to scan all the reagents available on the tray.

When you select this option, button for selective scan will be disabled.

If Reagent Absent, VOD or Liquid Level found different, errors are displayed
during pre-run activities then the corresponding reagent position is added to
the Refresh Positions screen. In this case user is advised to observe bottle
physically and take required corrective actions and then refresh the positions
manually to use that particular reagent bottle.

6.3.3.6 Run Options


Run Options is available on the Status Monitor. Make sure that respective run options are selected
before start of the run.

See the available run options in the following figure.

6.3.3.7 Work List


When insufficient volume details or incomplete test details are detected, during pre-run operations,
the work list screen may be displayed and the run is halted.

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Work List screen displays the sample and reagent details for the scheduled run. Work List screen
will be displayed if:

Reagents are absent for the programmed tests

The defined diluents are not present

Volume is insufficient for the programmed tests

When user clicks Work List button on Status Monitor

The work list screen is divided into two sections.

Schedules in Work List

This section will displays the information about Sample Position, Sample ID with Container
type, Sample Volume Required, Sample Type, Test, Sample Volume, R1 Volume Defined, R2
Volume Defined (optional), Number of Reagents, R1 Position Available, R1 Volume Available,
R2 Position (optional) Available, R2 Volume Available (optional).

Test(s) in work list will be highlighted in red background, in case parameters (such as Sample
Volume, R1/R2 reagent positions, Reagent Volume defined etc) are not defined completely. In
such case, a message “Incomplete Test Details” will be displayed above the grid.

Test for which calibration is require and mask test option is selected in Setting > Calibration
Policy for Closed Channel Tests > following messages will get displayed;

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Test for which calibration is required and do not start option is selected in Setting > Calibration
Policy for Closed Channel Tests > following messages will get displayed;

Reagent Volume Details

This section will display the information about reagent volume. Information such as RGT Type,
RGT Position, RGT Volume Available, Possible Test(s), Scheduled Test(s), RGT Volume
required.

If reagent volume available in the bottles is less than the reagent volume required for the total
number of possible tests then the column RGT Volume Available and RGT Volume Required is
highlighted with yellow background and a message “Reagent Volume Insufficient” will be
displayed above the volume grid.

Also, it will display the total number of possible tests (approximate) with the available reagent
volume.

Reagent bottles whose lot/bottle calibration is not done are displayed in Calibration Required
column in their respective tests row.

Open count

Analyzer accumulates open-channel Test-counts as obtained by scanning of each Reagent


pack Kit.

Analyzer performs open channel tests, not exceeding total permitted Test-count & reduces test
count based on test(s) performed on the analyzer.

It will also intimate user during run if Open Count reaches 10 & below.

Following buttons available on the Work List screen:

PROCEED

If the tests details for all the tests are proper i.e. without any tests having background as red,

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when this button is clicked, run will be started else run will not start.

CANCEL

Use this button to abort the run. However, clicking CANCEL during run will only close the screen.

Pending And Masked Test List

This button will be highlighted in red color if any test is masked due to incomplete test details or
when one or more test(s) are pending due to Sample/Reagent/Diluent/Special Diluent absent or
occurrence of VOD error.

To reschedule the pending tests, the corresponding tests should be selected and clicked on RE-
SCHEDULE button. Alternatively, the tests can be selected from the Test list, select Pending
option and click on RE-SCHEDULE button.

To reschedule the masked tests, the corresponding tests should be selected and clicked on RE-
SCHEDULE button. Alternatively, the tests can be selected from the Test list, select Mask option
and click on RE-SCHEDULE button. Click on CLOSE to close the screen.

Test(s) on Hold

Using this button, you can keep the specific test(s) on hold by masking them in work-list. User-
selected test(s) will be masked in the existing work-list as well as the new test order received
later, either through LIS or scheduled manually by user. On clicking, a test selection window
containing all the test(s) will displayed as follows.

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User can keep one or multiple tests on hold by selecting the check box, as per your requirement.
Once tests are selected, click on OK button to save the selections.

When the tests are selected during run, further tests will be masked. But
when the tests are selected before starting the run, then all scheduled
tests will be masked.

User can re-schedule the masked test(s) for all or selected samples, from
Status Monitor > Work List, even if the test(s) selected are on Hold.

Re-scheduling the Test(s) from the Work List will not automatically remove
the On-Hold status of the Tests.

Therefore, it needs to be done manually by un-ticking the tests from the


Test(s) on Hold window.

6.3.3.8 Selective Vol Scan


Selective Vol Scan option is used to perform volume scan of selective reagents position from the
list in offline mode.

1. On clicking Selective Vol Scan, following screen will get displayed:

2.

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3. After selecting the positions click OK.


4. Volume scan will get performed only for respective selected positions.
5. After completion of selective volume scan, volume get updated in respective reagent bottles in
Reagent Tray screen

6.3.3.9 Add Sample and Reagent (Barcoded)


Additional samples and reagents can be loaded on the trays using Status Monitor screen during run.
If you want to add a new bar-coded sample or reagent (continuous sample loading), the following
procedure should be used:

Adding Barcoded Reagent

lf the user wants to add a new barcoded reagent (Continuous Reagent Loading), the following
procedure should be used:

1. The user clicks on the Add Reagent button.

2. After the button is clicked, the message “Please Wait R1 Dispense Is In Process”.
Sampling will pause after the completion of Reagent 1 dispensing of the current test in
process.

3. After the button is clicked, the message “Please Wait R2 Dispense Is In Process”.
Sampling will pause after the completion of Reagent 2 dispensing. If no R2 is available,
then this message is not displayed.

4. Once the message disappears, a following message appears to open dome and add
reagent;

5. Now user can open the dome and place new reagent bottles.

6. Once the user is done with adding reagent, he can click on Added.

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7. Closed Dome to proceed message will be popped to close dome. User should close the
dome to proceed run. Reagent barcode scan will starts with message displayed as
“Please Wait Reagent Barcode Scan In Process”..

8. After the completion of reagent barcode scan, the reagent positions along with the barcode
details of the new test are updated.

9. The user can view the scanned reagent barcode data by clicking on the Barcode Scan
button.

10.The user can view the scanned reagent barcode data in Utility > Reagent Positions
screen.

11.While scanning, earlier barcoded reagent positions are cleared when the reagent barcode
is not found on the same.

On Add Reagent During RUN ,if Wash and Diluent position is not found
after Reagent Barcode Scan (i.e.user kept barcoded reagent bottle on
Diluent / Wash position), then either Pause further Sampling of that
batch with appropriate message OR mark associate Test(s) as
masked / pending and proceed with work list as applicable.

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Adding Barcoded Sample

If the user wants to add a new barcoded sample (Continuous Sample Loading), the following
procedure should be used:

1. Click on the Add Sample button in Status Monitor screen.

The Add Sample button is available only when Sample Barcode


option is ticked (set ON) from Settings > System Parameters screen

Message Please Wait Sampling Is Being Paused is displayed. Sampling will be


paused after completing the current test in process.

2. Following message appears to open dome and add samples;

3. Now user can open the dome and place new sample tubes in the sample tray.

4. Once the user is done with adding samples, he can click on Added.

5. Closed Dome to proceed message will be pooped to close dome. User should be close
the dome to proceed run. Sample Barcode scan starts with message displayed as Please
Wait Sample Barcode Scan In Process. On completion of the sample barcode scan,
each Sample ID, if not found in Patient Entry screen is added and the positions of new
samples get updated in the Patient Entry screen.

6. Sampling continue after updation.

7. The user can see the scanned data by clicking Barcode Scan button on the same screen.

Manual Pause

During Run if user Click on (pause), Message Please Wait Sampling Is Being Paused is
displayed. Sampling will be paused after completing the current test in process. Following
message will be appeared to open dome.

Now user can add samples / reagent > Close dome > Click on Resume to continue RUN.

When user opens dome immediately after clicking on Pause / Add


samples / Add reagent (before sampling is paused) then ARM movement

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will be stopped immediately and error message will be displayed in


error display grid.

6.3.3.10 Refresh Position


During run, if any of the reagents or diluents is absent then the position will be indicated as position
with empty bottle and will not be used during run, till you refresh the reagent position.

Hence, if the user wants to use that position, use Add Reagent. On clicking, sampling will be
paused, then open the Reagent cover. Then, put new reagent bottle at reagent absent position, close
the RGT cover. Make sure that 'RGT cover open ' message has disappeared. Then click on Refresh
Positions button either from Utility > Reagent Position screen or Status Monitor > Reagent Tray
screen.

1. On clicking Refresh Positions button, the following screen will be displayed.

2. This screen would display only those reagent positions which had an empty bottle (no volume)
at that position. If there are no empty bottles on the reagent tray then Refresh Positions
button would be disabled.

3. In the above screen, select the position at which filled reagent bottle is placed and hence
needs to be refreshed. Then, click on OK to refresh the position.

4. Click on All to select all positions at once and click on None to deselect.

5. Click on CANCEL to close the screen.

6.3.3.11 Scan Pack


Scan pack option is used to scan the details of System Pack Reagent kits for Closed channel
reagents.

On selecting this option reagent pack details will be displayed which contains Reagent name, Lot
number, Expiry date, Manufacturing date and number of reagent bottles with volume.
To scan the system reagent pack, keep the reagent pack in front of the Test loader device .
Refer section Front view
Click Status Monitor > Scan Pack > System Pack Details > Scan pack > following details will
get displayed.

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Click Register , system pack will get registered and messages will be displayed as "XL System
pack registered successfully" as shown below

When user scans the system pack from Scan Pack and if scanned Reagent code is not defined in
Consumables then following message will be displayed as " RGT Code Unknown " that means that
system pack is not registered by system.

To scan the Special Card, Click Status Monitor > Scan Pack > System Pack Details > Scan
pack > following details will get displayed;

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Click Register, card details will get registered and messages will be displayed as "XL System pack
registered successfully" as shown below

Open channel tests can also be loaded using special cards which may be
available for purchase from manufacture in special circumstances.

6.3.4 Reports
Reports is used to view the patient reports, error log details, reaction curve, reagent consumption,
ISE calibration, sample information, patient results, consumables, test parameters, calibration
results and control results etc.

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See the following screen for more details:

Patient Reports

Result Reprint

Test Statistics

Calibration Trace

Calibration Monitor

Error Log

Reaction Curve

Other

Search

6.3.4.1 Patient Report


Patient Reports screen is used for viewing and printing the patient reports. The reports can be view
as per the following search criteria:

Patient Name wise

Sample ID wise

Test wise

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Doctor wise

Patient ID wise

See the following screen.

See also:

Parameters to display records are per required selections.

Parameters Description
From and To This option is used to select the date range.
If the user selects Location, then Patient Reports related to that Location
Location can be viewed depending on the From and To date selected. Click on
SHOW to display the selected reports.
It is possible to search the patient results batch wise. Patient Records are
Batch displayed depending on the batch number selected. Click on SHOW to
display the selected reports.
Select the sample ID by entering initial characters of the sample ID, and
then click on SHOW to display the selected report. This will displays the
Sample ID
patient report related to that sample ID, depending on the From and To date
selected.
Select the patient ID by entering initial characters of the patient ID, and
then click on SHOW to display the selected report. This will displays the
Patient ID
patient report related to that patient ID, depending on the From and To date
selected.

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Select the doctor from the list. Click on SHOW to display the report. This
Doctor Name will displays the patient reports related to that Doctor, depending on the
From and To date selected.
Select the required test by clicking on three dotted button. After test
Test selection, click on SHOW to display the report. This will displays the
patient reports depending on the From and To date selected.
Select the patient name by entering initial characters of the patient name,
and then click on SHOW to display the selected report. This will displays
Patient Name
the patient report related to that sample ID, depending on the From and To
date selected.

Select any one relevant option to display the results

Photometric Tests: If the user selects this option, then only photometric test results are
displayed. By default, this option is selected.

Calculated Items: If the user selects this option, then only calculation item results are
displayed.

Offline Results: If the user selects this option, then only Offline Entry results are displayed.

ISE Results: If the user selects this option, then only ISE Results are displayed.

Rerun Results: If the user selects this option, and then only Rerun results are displayed.

Recalculated Results: If the user selects this option, then only Recalculated Results are
displayed.

All: If the user selects this option, then all results (Photometric Test, Offline Results, ISE
Results, Rerun Results) are displayed

Select the Report Options to display the following information on printed reports

The report options will be memorized once the patient report is printed.

These memorized selections are made available as default selection for


subsequent use of the Patient Report screen, which can further be changed
by the user, as required.

Using the reports options, you can customize the generated report outputs.

Print Lab Details: This option is used when the user needs to print the Lab details. Refer
section System Parameters for entering the lab details.
If the user has clicked on the Print Lab Details check box, then the Laboratory details are also

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printed in reports.

Hide flags: This option is used when the user wants to print the Reports without printing the
associated flags. If this option is selected, the column Flag will not be displayed in the printed
patient report.

In the printed report, the up and down arrow will be displayed if H and L
flag is attached with sample result.

The up and down arrow with H and L flag will be displayed even if the
option Hide Flags is selected in the Report Options in Reports > Patient
Report screen.
N! Flag will be applied for patient results when final result displayed is
negative in Patient Report Screen.

Show Location: This option is used when the user wants to print the Reports with or without
.printing the Location details.

Show Analyst: This option is used when the user wants to print the Reports with or without
printing Analyst details.

Show Sample Remarks: This option is used when the user wants to print the Reports with or
without printing the Sample Remarks.

Show Patient Remarks: This option is used when the user wants to print the Reports with or
without printing the Patient Remarks.

The labels Location, Analyst, Sample and Patient Remarks are not printed on
the report if the user de-selects them in Patient Reports.

Patient report formats

Different patient report formats are available.

Normal

This is a basic report format. The order of printing results of photometric tests, calculated
items and ISE can be set from the Test Sequence screen using PRINT SEQUENCE FOR
PATIENT REPORTS option.

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Multi Column

This format facilitates to print patient results in two-columnar format, like newspaper. See
figure below.

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Profile

If the user has selected profiles for scheduling tests from Patient Entry screen, then the user
can print Patient Reports as per the various Profiles selected.

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Graphical

Patient results and defined reference ranges are graphically represented in this format. Refer to
following figure for example.

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The patient report’s footer information, top and bottom margin, and signature
will be displayed at the bottom of the report. These settings can be configured
through Settings > System Parameters screen.

Buttons available on the screen

If the regional language is selected other than English from Settings > System
Parameters, then the data displayed under column Category and Sample
Type will be in the selected regional language in the printed patient report.

PRINT: Click this button to print the report.

PREVIEW: Click this button to view patient results that are selected for printing; before actually
printing them.

The report options will be memorized once the patient report is printed.
These memorized selections are made available as default selection for
subsequent use of the Patient Report screen, which can further be changed
by the user, as required.

Online Patient Report printing will also use these memorized options.

The following options are available for selection.

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Abnormal Results: If the user selects this option, then Results with flag are displayed.

Undo Selection: This option is used to clear the previous selection.

6.3.4.2 Result Reprint


Result Reprint screen is used to retrieve and print the results date wise or for the last batch.

After selecting the required parameters, click SHOW to display the results.

See the following screen.

See also:

Parameters to display results in date wise or batch wise

Parameters Description
Last Batch Select this option to display the results of the latest batch.
Select this option to display results for a specific date or range of dates.
Then select the From and To dates from the calendar drop-down list.
Date wise During run, maximum 7 days data will be displayed for
patients and maximum 30 days data will be displayed for
controls and calibration.

Search results by selecting the following parameters

Parameters Description

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Select appropriate option to view the details.


Patient or
Controls or During run, patient results of maximum 7 days at a time will
Calibrations be displayed, whereas Calibration and Control results of
maximum 30 days at a time will be displayed.
Select this option to display results for a specific date or range of dates.
Date wise
Then select the From and To dates from the drop-down calendar.
Patient Name Select the patient name by entering initial characters of the patient name.
Patient ID Select the patient ID by entering initial characters of the patient ID.
This will displays all the patient records of all dates which are present in the
Any Date
database.

Print patient name, ID and lab details on printed reports

Parameters Description
If you want to print the lab details on the printed patient report, check this
Print Lab Details
option and then click on Print button.
On checking this option, the additional column Patient ID and Patient Name
Print Pat ID,
column will be displayed on the print report in the landscape orientation. If
Name
this option is not selected, the report will be generated in portrait orientation.

Command buttons

Parameters Description
This button is used for sending the selected results to the LIS, after batch
run is completed.
This button is visible only if the Host Connection in System
Parameter screen is checked.

While sending the results to LIS during run, if the connection


Send to Host
between LIS and Analyzer is disconnected, a message will
be displayed “LIS Connection is not Responding” in Status
Monitor.

For any test containing "µ" in unit, "µ" gets transmitted as "u"
to LIS.
Print This button is used for printing the Results on printer or PDF writer.
Export This button is used for export the Results on an excel sheet.
Use this button to invert the selection that is made. Clicking on this button
Inv. Selection
will select the unselected items and vice verse.
Select All Use this button to select all the results displayed on screen.

Use the filter data options to filter patient’s results

Parameters Description
Test Displays results as per selected test from list.
Sample ID Displays results as per selected sample ID from list.
Batch Displays results as per batch number selected from list.

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Total Tests: This field displays the total number of tests performed for the selected criteria

Total Tests count will be refreshed only on click of SHOW button and not on
click of check box of every row in the grid showing data.

Description of each column displyed in the grid

Column Name Description


Sample ID Displays the sample ID of the patient
Patient Name Displays the patient name
Test Displays the test name
Result Displays the test result
Unit Displays the test unit
Flag Displays the flag associated with the test result
Result Date Displays the date on which the test was performed
Curve No. Displays the reaction curve number.

To view the reaction curve, double-click on the


Reaction Curve number in the column “Curve #”. A
new window with the curve and reading points
displayed. Click on “Close” button to close this
window and go back to the Result Reprint screen.

This facility is available when the batch run is not in


progress.

6.3.4.3 Test Statistics


Test Statistics screen is used to view the test statistical details of batch run. Based on the selection,
results will be displayed.

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See also:

Parameters for Selection

Parameters Description
Date From Enter the beginning date for the results to be analyzed.
Date To Enter the ending date for the results to be analyzed.
Use this option to view the results batch wise. Batch number will be
Batch
displayed only when date is same.
Select the test name to view its statistics. Results of the selected test
Test which is performed on the analyzer is displayed according to Patients,
Controls or Calibration selection.
Select this option if test statistics for a particular age group is required.
Age
Enter age range and press Filter button to get the result.
Select this option if test statistics for a particular test value is required.
Result
Enter result range and press Filter button to get the result.
In case, the user requires the laboratory details to appear as header on the
Print Lab Details
Test Statistics report, then select this option.
Use this option to view result statistics of specific rows displayed on the
S#
screen. Then enter the range of rows in the Start From and End To.
Use this option to specify patient name/consumable for which you want to
Patient Name obtain the statistics. Then enter first few characters of the patient or
consumable name.

Statistical Details

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Normal Range: Displays the total number of results that were within the normal range defined in
the Reference Ranges screen.

Above Normal Range: Displays the total number of results that were above the normal range
defined in Reference Ranges screen.

Below Normal Range: Displays the total number of results that were below the normal range
defined in the Reference Ranges screen.

Not defined: Displays the total number of results whose reference ranges were not defined in the
Reference Ranges screen.

Total Tests: Displays the total number of results/absorbance’s available.

N: Displays the total number of tests used for calculating the Mean, SD and %CV for a test.

Mean: Displays the average of the result/absorbance that has been selected (checked).

SD: Displays the Standard Deviation of the result/absorbance that has been selected.

%CV: Displays the %CV (coefficient of variation) of the result/absorbance that have been selected
(tick-marked)

Range: Displays the Range of the results that fall within the selected criteria. It shows the
difference between the minimum and maximum range for the same.

Sr#: Use this button to select the range of results/absorbance’s for which you want to obtain the
statistics. Enter the range in Start From and End To textbox. Once the range is entered, click on
Calc button to obtain the statistics.

Command Buttons

Select All: This button is used to select all the sample records for a test.

Invert Selection: This button is used to clear all the selections.

Print: This button is used for printing the Test Statistics for the selected Test in Report format.

Export: This button is used to export the Test Statistic details into the excel sheet and saved in
location C:\MultiXLLOG\TestStatistics.

Calc: This button is used to recalculate the statistics in the other grid at the left-bottom corner of
the screen; as per the result data displayed in screen (based on the sub-filters, such as Sr#,
applied to the result data).

Reset: This button reset the values entered in the Start From and End To textbox.

During run, maximum 7 days data will be displayed for patients and maximum
30 days data will be displayed for controls and calibration.

6.3.4.4 Calibration Trace


Calibration Trace screen is used for displaying the calibration history of a test along with the
graphical representation of calibration data over one month.

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See the following figure:

This table describes the description of each parameters:

Parameters Description
It is used for selecting the desired test whose calibration history needs to be
Test Name
viewed.
It is used for selecting the month and the year for the test whose calibration
history needs to be viewed. Once the test and the month selection are done,
the grid displays the different calibration dates and time along with the
Month and Year
absorbance’s for blanks and standards. Also, a graphical representation of the
Blanks and Standards can be viewed.]
Blank: It is used to change the range of blank absorbance.

Blank It is used to change the range of blank absorbance.

It is used to change the range of standard /calibrator absorbance.

Standard/Calibrator Use Reset button to reset the range for blank, standard and calibrator
absorbance to range according to the minimum and maximum absorbance of
the blanks, standards and calibrators.

Use Export button to export the data and graph displayed on screen to an excel sheet.

Use Print button to print the data and graph displayed on screen.

6.3.4.5 Calibration Monitor


Calibration Monitor screen is used to view the latest calibration details of all the tests at the same
time.

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See the following screen.

Following table displays the description of each column in the grid.

Column Description
Test Test name.
Curve Type Type of Curve assigned for that chemistry.
Type Either Blank or Standard S1,S2…etc.
Consumable Name of the consumable.
Lot# Lot no. of consumable used .
Conc. Concentration of the consumable .
Abs. Absorbance of the Blank/Standard.
Factor Factor value of the standards.
Calib. Exp Calibration Expiry Limit (in Days).
Acceptable Limit Acceptable Limit for New Factor.

Use Export to export the calibration data to desired location.

Use Print to print the calibration data.

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6.3.4.6 Error Log


Error Log screen is used to display the list of errors that is occurred during machine operation. The
list of errors can be filtered according to the type of operation by selecting option All, Run, Service,
Maintenance and Host. This data is generally useful for service/diagnostic purposes.

1. Select the date range by changing the From and To date.

2. Select the operation (All, Run, Service, Maintenance, or Host operations) during which the
errors occurred.

3. Click on Show button to view all the errors.

4. Use Error Code drop down list is used to filter the records as per requirement.

5. In the grid following are the different fields present:

Date – Date and Time of the occurrence of the error.

Batch No – Batch number during run, in which the error occurred.

Error Code – Displays the error code to identify the type of error occurred.

Description – Description of the error occurred.

Action – Action taken on the error occurrence is displayed in this column.

The column “Action” represents the severity of the error, which is as follows:

Pause-P states that the sampling will be paused on occurrence of such errors

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during run. User may take corrective action and resume sampling by clicking on
the Resume button from Status Monitor.

Pause-R states that the sampling will be paused on occurrence of such errors
during run. On occurrence of such errors, resume sampling in same batch is not
possible. Once the results of all the tests in progress are declared, the batch run
will stop. When the batch run is completed, user should take corrective action and
then start the run again.

STOP states that the analyzer will stop the batch run immediately on occurrence
of such errors.

Errors having blank Action states that they are warnings.

Error description is displayed along with the date and time.

6. To print the details of the error log, user can click on Print button.

7. Use EXPORT button to save the records in the excel sheet. On clicking, the details will be
automatically copied in the excel sheet and the file is saved in the particular location. The
location will be displayed in the Indication text box.

In Bottle Discarded error message, the first three digits denote the Lot no.
whereas the next four digits denote the Bottle no. of the Reagent Bottle
followed by the Reagent Name (as scanned by the barcode reader).

6.3.4.7 Reaction Curve


Reaction Curve screen can be used to view the reaction course (absorbance vs cycle number) for any
reaction.

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The reaction curve can be viewed test wise and sample ID wise for patient results or Test wise and
Consumables wise for Blank, Standard/Calibrator and Control Results.

Click on the dotted button near the test text box to select the required test. Click on the dotted
button near the Sample ID text box or consumable text box to select Sample ID or Consumable
respectively.

Use crossed button to clear the respective selection criteria in the adjoining text box, as required.
See the following figure.

Alternatively, one can also search a specific curve number by ticking Search By Reaction Curve
No. check box and then entering the reaction curve number in Curve No. text box (It allows to enter
up to 9 digits). The user has to click on SHOW to view the reaction curve as per selection.

Reaction curve number is a unique serial number assigned by the program during analysis. The
reaction curve number can be obtained from the Result Reprint screen. The absorbance values for
the selected time course are displayed in a tabular format as well as graphically.

M1S, M1E, M2S, M2E and Extended M2E and also Ap, As, Ap-As for a particular chemistry are
shown on the time course. These points can be identified by legends placed below the time course.

R2 addition line is shown with the red arrow.

The time course display also contains the following details regarding that reaction curve.

Result: It displays the result of the test selected.

Flag: It displays the flag associated with the Result.

Primary Wavelength: It displays the primary wavelength to be used for measurement of that test,
as set in the Test Parameter > Test Details screen.

Secondary Wavelength: It displays the secondary wavelength to be used for measurement of that
test, as set in the Test Parameter > Test Details screen.

Assay Type: It displays the Assay Type for that test, as set in the Test Parameter > Test Details
screen.

Average O.D./Delta Abs/min: It displays the Average O.D. for End Point Assays or Delta Abs/min
value for Rate Assays; calculated within the specified time intervals for that test. .

Format: It allows selecting either to display in the graph only Ap (Absorbance at Primary
Wavelength) or only As (Absorbance at Secondary Wavelength) or both Ap and As or Ap-As or All.

An explanation of various columns shown in the table is given below:

Column Name Description

Cycle Absorbance cycle numbers are displayed in this column.

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Absorbance of the reaction mixture at primary wavelength after


Ap
subtraction of cuvette blank absorbance at primary wavelength.
Absorbance of the reaction mixture at secondary wavelength after
As
subtraction of cuvette blank absorbance at secondary wavelength

The difference in absorbance at primary and secondary wavelength after


Ap-As subtraction of cuvette blank absorbance (that is, it is the difference of
Ap and As).

Click on to zoom in / zoom out the Y axis (Absorbance) scale to enlarge the graph within the
minimum and maximum absorbance for that curve. Click twice on the Reaction Curve graph to obtain
a zoomed view. Double-click again to zoom out.

Following are the other buttons present on screen:

Use navigation buttons to view the previous or next reaction curve number details.

PRINT: Click on this button to print the reaction curve details along with the graph.

EXPORT: Click on this button to export the selected reaction curve details along with the graph to
the specific location. After exporting the data successfully, the file name along with the path is
displayed as a message as well as in Indication text box in the bottom of the screen.

CLEAR: Click on this button to remove the details of the selected reaction curve number.

6.3.4.8 Other
Other option gives the report of Reagent Consumption,ISE Calibration,Reagent Bottle History and
Pack Details

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Reagent Consumption screen in used to display the following information:

Total consumption of reagents

ISE calibration details

Use SHOW to view the data over the selected date range.

Use PRINT to print the report.

Use EXPORT to export data in excel sheet. Excel sheet is saved in the location C:\MultiXLLOG\ in
the *.XLS format.

Reagent Consumption

Reagent Consumption option is used to view the total number of times the each test are
performed for Patient, Calibrator (including Blank and Standards) and Control on the analyzer.

You can obtained the required data by selecting Reagent Consumption radio button and
entering date range. After selecting date, press SHOW to display the data.

See the following screen.

ISE Calibration

ISE Calibration option is used to display the ISE calibration details.

Select ISE Calibration radio option. This will displays the calibration details on the screen.

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Use PRINT or EXPORT, as appropriate.

Reagent Bottle History

Using this option, you can view list of discarded / Non Discarded / ALL reagent bottles. The data
can be obtained by selecting date range in the From and To drop-down list.

To view the Discarded / Non-Discarded / ALL bottles, go to Reports > Others and select Reagent
Bottle History option, select required date range, select option Discarded / Non-Discarded / ALL
from drop down list as shown in below figure.

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Then click on SHOW. Following screen with data will be displayed.

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In Bottle no. column, the first three digits denote the Lot no. whereas the next
four digits denote the bottle no. of the Reagent Bottle.

Pack Details

This option is used to give details of System Pack Reagent kits. User can view list of details as
Pack no, Reagent name, Register date, Lot no, Mfg date, Expiry date, Open count no, Volume
scanned from pack up to 2 decimal, Bottle type, Bottle no, Discard status and date. The data can
be obtained by selecting date range in the From and To drop-down list.

To view the Pack details, go to Reports > Others > Pack Details option,select required date
range and then click on SHOW. The following screen with data will be displayed.
To view the pack details of particular reagent, go to drop down list > select the reagent from the
list > only selected reagent pack details will get displayed on the screen.

Open Test Count Details

This option provides details of open test count after registry of system packs and special cards.
User can view the list of details as Pack no, Reagent name (for special card it shows as CARD),
Registration date, Expiry date, Validity, Open Counts, Open Counts Balance and expiry of card.
The sorted data can be obtained by selecting ALL / Expired / Balance from drop-down list.

To view the Open Test Counts, select Reports > Others > Open Test Count Details, select
required options from ALL / Expired / Balance and click SHOW. The respective details will be
displayed.
Validity (days) If available on reagent pack / card, then it will be stored for expiry of days counts

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loaded from the respective pack.In case, validity of Open-counts is not available from reagent
Packs / cards then it consider as no-expiry for those Open counts.
Open test counts will get incremented after registered of reagent packs or special cards.
System will consume the Open Test Counts in the order of their Expiry. Thus, open test counts
without Expiry (from existing packs) will be consumed at the end. It will not use Open counts after
respective Expiry (validity) & before its scan-date.
Open-channel tests will be allowed only till open counts is available

6.3.4.9 Search
Search is used to search Consumables, Test Parameters, Patient Information, Sample Information
and Result. The following screen will be displayed.

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See the following section in more details:

Patient/Sample

Patient Results

Calib/Control Results

Consumables

Tests

6.3.4.9.1 Patient/Samples

Patient/Samples screen is used to search the patient and sample information.

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Enter any one or more parameters to search the required output:

Parameters Description
Patient Name Enter the patient name.
Patient ID Enter the patient ID.
Doctor Select the patient's doctor name.
Sample ID Enter the sample ID.
Sample Type Select the sample type from the list.
Collection Date Enter the date range on which the sample is collected.
Reg. Date Enter the date range on which the registration is done.

Use two or more combination from above parameters to make advance search.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. In the search result, you can able to see the name of the operator and the modified date in
Operator ID and Modified On column.

The above selection can be cleared using Reset button.

6.3.4.9.2 Patient Results

Patient Results screen is used to search the patient results.

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Enter any one or more parameters to search the required output:

Parameters Description
Patient Name Enter the patient name.
Patient ID Enter the patient ID.
Doctor Select the patient's doctor name.
Flag Select the required flag from the list.
Test Select the required test from the list.
Sample Type Select the sample type from the list.
Sample ID Enter the sample ID.
Result Date Enter the date range.

Use two or more combination from above parameters to make advance search.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. Result Date column will displays results date along with time.

The above selection can be cleared using Reset button.

6.3.4.9.3 Calib/Control Results

Calib/Control Results screen is used to search the calibration and control results.

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Select the required consumable type and then enter any one or more parameters to search
the required output:

Parameters Description
Lot No. Enter the consumable lot number.
Test Select the name of test from the list.
Flag Select the name of flag from the list.
Enter the date range.
Result Date From
During run, the date difference to view the records should be 30 day.
Result Date To

There is a choice of searching the entire consumables or selecting one consumable at a time.

After providing necessary inputs, press Search button. The search results will be displayed in the
grid. Result Date column will displays results date along with time.

The above selection can be cleared using Reset button.

6.3.4.9.4 Consumables

Consumable screen is used to search the consumable information.

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Select the required consumable type and then enter any one or more parameters to search
the required output:

Parameters Description
Manufacturer Select the list of manufacturer from the list.
Enter the expiry date range.

Expiry Date This is not applicable to Blanks, Diluent or Wash Solution.

Lot No. Enter the lot number.


Whole word Select any one search option, as appropriate.
Match

After providing necessary inputs, press Search button.

The above selection can be cleared using Reset button.

6.3.4.9.5 Tests

Test screen is used to search the tests parameter details according to the specified inputs.

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Enter any one or more parameters to search the required output:

Parameters Description
Primary Wavelength Select the required primary wavelength.
Secondary Wavelength Select the required secondary wavelength.
Assay Type Select the assay type
Curve Type Select the curve type.
Reaction Direction Select the appropriate reaction direction from the available options.

After providing necessary inputs, press Search button.

The above selection can be cleared using Reset button.

6.3.5 Tests
Tests screen is used to define the analytical parameters and reference range of the tests. The
efficiency of the test depends on a proper choice of the test parameters.

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Test Parameter consists of three screens.

Test Details

Test Volumes

Reference Range

Profiles

Calculated Items

6.3.5.1 Test Details


This screen will display the list of available default tests with their default parameters. For a particular
test, parameters which are highlighted in gray color textboxes are not editable. To make all
parameters editable, you first need to copy a test with different test name and then make changes.

Using this screen, you can perform the following operations.

Defining new or modify the existing test parameters

Setting auto rerun for multiple test

Copy Test

Down load and upload parameters for a test

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Initialize tests from existing ones to default settings

When you see some of the parameters in the Test Parameters screen disabled,
please switch on the analyzer.

Test parameters are not editable during the batch run.

Key default tests parameters are not editable except user defined tests.

Every default tests will displays a revision number on top right of the screen for
identification. Using this, user can match the revision number with the one
printed on the kit insert provided in reagent pack to ensure correct parameters
are used with the pack of measurement.

Revision number is displayed on Test Details, Test Volumes, and Reference


Ranges screen for default parameters.

User is allowed to define or add only permitted number of open channel tests
(user defined), after that system will prompt a message.

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6.3.5.1.1 Test Definition Parameters

This table describes the description of each parameters:

Parameters Description
Test It displays the name of test when clicked on any of the default test from the
Tests grid. For a user defined test, enter a short name for the Test, maximum
up to 5 characters. This test name is used to select / display test(s) on all
screens. A unique name is required for each test as this is the identity. Enter
the name along with appropriate parameters and click on SAVE. Newly
created test name will appear at the end of the Test panel in the bottom of
the screen.
Report Name Enter the full name (50 characters maximum) of the test (assay) that will
appear in the patient report. For example, one feeds Aspartate Transaminase
in this text box, while AST is entered in Test text box.
Host Name Enter test name, up to 5 characters, assigned in the LIS. This name could be
same or different to the Test Name. This text box will be available only if the
Host Connection is activated from Settings > System Parameters screen.

Use this button to view and modify the host name of any Tests in list, if
required. On clicking, the following screen will be displayed.

Select the required test and click EDIT button. Click SAVE after making
changes in host name.
Total Reagents Select the total number of reagents used for the test. The drop-down list
gives selection of 1 or 2 reagents for single and dual assays respectively.

The default value for this parameter is 1.


Reagent R1, Upon selecting the Total number of Reagents, the Reagent Name needs to
Reagent R2 be selected. This is different from Test Name. Reagent Name is defined in
Consumables > Reagents screen. Select the name of the Reagent to be
used for the test. This is the name that appears in the Utility > Reagent
Position screen while viewing / defining the positions of the Reagents placed
on Reagent Tray.

More than one test can share the same Reagent Name.

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Assay Type

Use this pull-down option to select the assay type among 1POINT, 2POINT,
RATE-A and RATE-B. It is recommended to use:

1 POINT for end point chemistries

2 POINT for end point chemistries using sample or reagent blank

RATE–A for kinetic/rate assay

RATE–B for kinetic/rate assay with differential slope

1 POINT:

The method is used for normal end-point assays using one or two reagents
where the final absorbance is used for concentration calculation. Mean of the
absorbance’s recorded between M2Start and M2End points are taken and
this is used for the calculation of the sample results.

2 POINT:

This method is used for end-point analysis when a sample or reagent blank is
necessary. In this assay type, the initial absorbance (usually measured after
addition of the first reagent) is recorded and subtracted from the final
absorbance (which is usually measured after addition of the second reagent).
Necessary correction factors to correct the difference in mixture volume are
taken into account while subtracting the initial absorbance. The initial
absorbance recorded is the mean of the absorbance’s recorded between
M1Start and M1End and this absorbance is subtracted from the final
absorbance, which is the mean of the absorbance’s recorded between
M2Start and M2End. This differential absorbance is then used for calculation
of sample concentration.

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RATE-A:

This method is used for kinetic/rate assays where the change in absorbance
per minute is used for result calculation. The slope (absorbance change per
minute) is obtained from the absorbance’s recorded between M2Start and
M2End using the least square linear regression method as per the following
formula:

.
Where, Ti is the time in minute and Ai is the absorbance, n is the number of
points.

RATE-B:

This method is used for kinetic/rate assays where differential rate is useful.
The initial rate of change in absorbance per minute (usually obtained after
addition of the first reagent) is subtracted from the final rate of change of
absorbance per minute (usually obtained after addition of the second
reagent). Necessary correction factors to correct the difference in mixture

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volume are taken into account while subtracting the initial rate of change in
absorbance per minute. The initial rate of absorbance change per minute is
recorded between M1Start and M1End using the least square regression
method and is subtracted from the rate of change in absorbance per minute
recorded between M2Start and M2End using the least square regression
method explained in the section on RATE-A assay type.

M1 Start and M1 These assay points are used to select the time points for measurement of
End initial absorbance for 2POINT and RATE-B assay types. This absorbance
serves as reagent or sample blank. This initial absorbance (or absorbance
change per minute) in these assays is subtracted from the final absorbance
(or absorbance change per minute) that is measured between M2Start and
M2End points. M1Start and M1End can have values from 1 to 36 for 2POINT
and RATE-B assays.

In case of 2 POINT chemistries, the mean of the absorbance’s obtained


between M1Start and M1End is calculated. In case of RATE-B chemistries,
the change in absorbance per minute is calculated between M1Start and
M1End points using least square linear regression method.

M1End should always be equal to or more than M1Start. The difference


between M1End and M1Start should be at least three in case of RATE-B
assay. In addition, M1End has to be less than or equal to M2Start. For
1POINT and RATE-A assays, M1Start and M1End should be programmed as
"0".
M2 Start and M2 It is essential to program M2Start and M2End parameters for all the tests
End and these parameters can have values from 1 to 36. M2Start specifies the
incubation time point. Similarly, M2End is the time until when the
absorbance is recorded for the purpose of concentration calculation.

In case of 1POINT and 2POINT chemistries, the mean of the absorbance’s


obtained between M2Start and M2End is calculated. In case of RATE-A and
RATE-B chemistries, the change in absorbance per minute is calculated
between M2Start and M2End points using least square linear regression
method.

For 2POINT and RATE-B chemistries, M2Start has to be more than or equal
to M1End.

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Wavelength- This is used to select appropriate primary and secondary wavelengths for
Primary absorbance measurement. The measurement wavelengths are selected from
8 fixed values provided. In case of bi-chromatic measurement, the final
absorbance is obtained by subtracting the absorbance at the secondary
wavelength from that at the primary wavelength. For monochromatic
measurements, use “Select” for secondary wavelength

The analyzer offers a choice of 8 wavelengths with a narrow bandwidth (<8


nm) for programming the wavelength. The choices are 340 nm, 405 nm, 505
nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm.
Secondary When the methodology specifies bi-chromatic measurement for an assay,
user can select a secondary wavelength at which the absorbance can has to
be measured. The selection is made with the pull-down option provided. The
following secondary wavelengths are available in the analyzer: 340 nm, 405
nm, 505 nm, 546 nm, 578 nm, 600nm, 660 nm, and 700 nm.

If bi-chromatic measurement is not desired i.e. for monochromatic


measurements, keep the choice as “—SELECT—” for the value of the
secondary wavelength.
Control Intervals The Control Interval parameter enables the user to define number of samples
after which the control serum will run automatically. This interval can be
selected between 0 and 1000. For example: Control Interval = 30 means that
control serum will be run after every 30th sample analyzed for that chemistry
Sample Enter the value between 1 to 30 stating the number of repeated sample
Replicates measurements to be performed for the selected chemistry Repeated sample
measurements are usually used to check repeatability. All samples
programmed for this chemistry will be repeated for the programmed number
of times. For routine operation, this parameter is programmed as '1'.
Standard Enter the value between 1 and 3 stating the number of repeated blank and
Replicates standard measurements to be performed for the selected chemistry. It is
recommended to repeat the measurements 3 times. Average of the two
closest replicates would be taken while updating absorbance of Blank and
Standard in the Calibration screen.
Control Enter a value between 1 and 30, stating the number of repeated control
Replicates measurements to be performed for the chemistry. Repeated control
measurements are usually used to check repeatability.
Delta Abs/min This input is used for cancellation of Reaction Linearity Check and is used for
low linearity samples. The user needs to enter the delta absorbance/min for
that test where the Linearity Check should not be performed. Once fed, if the
delta absorbance/min of the reaction for that test is less than the set limit,
then Linearity Check will not be performed.
Linearity Limit % This parameter is applicable only for Rate-A and Rate-B assay types and
monitors the linearity during the reaction. The user can feed any value
between 1% to 30%. If the %Linearity exceeds the specified value in the
Maximum Reaction Linearity, then a LINXX flag is displayed and result will be
declared as NA. This flag is applicable for Patient Samples, Control &
Standard / Calibrators and Not for Blank. Enter “0” in this text box, in case
the check is not desired.
For e.g. if the user specified a value of 5% in the Reaction Linearity
parameter and if the linearity percentage is exceeded, then flag LIN5 will be
issued and result will be declared as NA.

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Unit Use this option to select unit of measurement for the analytes from a drop
down box. If you do not find the desired unit from the available options, you
can enter a new unit by going to Master > Units screen.

User can define or can create any number of units in Master >
Unit screen.

Reporting Unit Enter the reporting unit from the drop down list. User can defined the
reporting unit from Master > Unit Conversion
Decimal Places Enter the number of digits to be displayed and print; after the decimal point of
the test results. Enter the number of digits between 0 and 5.
Prozone Limit % Specify the minimum limit for the absorbance at the end of an
immunoturbidimetric reaction as a percentage of the maximum absorbance
observed during the course of a reaction. Prozone limit should be between 0
to 100%. If the percent ratio of the final absorbance (at M2E) with the
maximum absorbance in the time course (up to the point M2E) violated the
prozone limit, a flag P* is issued and result will be declared as NA. If the
option Auto Rerun is selected, the sample is automatically sent for a
Decreased volume rerun. If you want to make sure that the absorbance is
increasing monotonically in the time course, feed a value of 100(%). Enter “0”
in this text box, in case the check is not desired.

Prozone Limit is applicable only for Non-Linear curves.

Prozone Check This displays whether the entered value is an upper limit or lower limit. For
increasing reaction direction chemistries, it is displayed as “Lower” and for
decreasing reaction direction chemistries; it is displayed as “Upper”.
Technical Define the Linearity Limit of the reagents in terms of concentration.
Minimum
For the 1 POINT, 2 POINT, Rate-A and Rate-B chemistries, feed the
minimum and maximum concentrations in the Technical Minimum and
Maximum Technical Limit text boxes respectively.

Enter a value ranging from -99999.99 to 99999.99 indicative of the minimum


technical limit or the linearity limit of the reagent. For end-point chemistries
and rate chemistries, feed the minimum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. Samples that violate this limit are sent for
increased volume rerun. If you do not wish to use technical limit minimum,
feed a zero value.

If the Reaction Absorbance Limit parameter is not zero for


the RATE ASSAYS types, then the Technical Limit
parameters will be masked and vice-versa.

If Tech Limit Min is violated (Final Result < Technical Limit Minimum value), a
flag “TEC-L” is issued and result will be declared as NA. If the option Auto
Rerun is selected, the sample is automatically sent for an increased volume
rerun.

Similarly, if Tech Limit Max is violated, a flag “TEC-H” is issued and result will
be declared as NA. If the option Auto Rerun is selected, the sample is

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automatically sent for a decreased volume rerun.

Technical Define the Linearity Limit of the reagents in terms of concentration.


Maximum
Enter a value ranging from -99999.99 to 99999.99 indicative of the maximum
technical limit or linearity limit of the reagent. For end-point chemistries and
rate chemistries, feed the maximum concentration. The concentration
entered for Rate Chemistry will automatically be converted into rate after
calibration of that test. This value will be used for comparing with the slope
obtained during patient run. Samples that violate the programmed technical
limit maximum are sent for Decreased volume rerun. If you do not wish to use
technical limit maximum, feed a zero value.

The Technical Limit (Minimum and Maximum), Reaction


Absorption Limit, and Linearity Limit parameter are
applicable only for Linear and K-Factor curve types.

Technical Limit Minimum or Maximum when ‘0’ (Zero),


indicates that the respective check is not required for the
test.

If the Reaction Absorbance Limit field is not zero for RATE


ASSAYS, then the Technical Limit fields will be masked
and vice-versa.

Curve Type This pull down list is used for defining the calibration curve type for that test.
Reaction This parameter defines the direction of the absorbance change with time for
Direction the reaction mixture. Specify whether the absorbance of the reaction mixture
increases or decreases with time.
React. Abs. Define the absorbance limit of reaction mixture for Serum/Urine samples.
Limit (Reaction Enter an absorbance limit for reaction mixture, depending on the reaction
Absorbance direction (increasing or decreasing). For rate chemistries, the absorbance
Limit) limit is that absorbance at which the substrate depletion is detected. The
absorbance limit entered would be in direct absorbance and not in terms of
delta absorbance per minute. For increasing direction chemistries, enter the
maximum allowed final absorbance before substrate depletion takes place.
For decreasing direction chemistries, enter the minimum allowed final
absorbance before substrate depletion takes place.

If Technical Limits are not entered and if the Reaction Absorbance Limit is
exceeded during the course of reaction then the last point of the
measurement interval (i.e. M2E) is automatically shifted to the point where
this limit has been exceeded to avoid sample rerun phenomenon. This new
point is automatically used for calculation of sample concentration.
.
Also, in the Reaction Curve Screen, the new point would be shown using a
dotted line, stated as Extd. M2E indicating that the extension logic has been
applied to calculate the result.

If no points are available for slope calculation, then Lim0


flag is issued and the result is NA (not declared).

If only one point is available for slope calculation, then


Lim1 flag is issued and the result is NA.

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If only 2 points are available for slope calculation, then


Lim2 flag is issued along with the result.
.
Maximum permissible entry is 2.5. In case the reaction absorbance check is
not desired, put “0” in the React Abs Limit text box. Extension logic will not
be applied if the Reaction Absorbance limit is set to zero.
.
For rate chemistries, if Technical Limits are entered and if any point between
M2S and M2E exceeds the Reaction Absorbance, AbsLim Flag is attached
and result will be declared as NA. If option Auto Rerun is selected, the test
is sent for a decreased rerun.
.
For end point chemistries, if final O.D calculated exceeds the Reaction
Absorbance, AbsLim Flag is attached and result will be declared as NA. If
option Auto Rerun is selected, the test is sent for a decreased rerun.
Y=aX+b These fields can be used to perform correlation correction so that the results
(Instrument obtained on this analyzer can be matched with those obtained on some other
correlation analyzer. For some assays, the analyzer might give results that are
factor) consistently higher or lower than expected or obtained on another analyzer.
To match the results with the expected results or the results obtained on
another analyzer, a correlation correction can be incorporated in the result
calculations. The equation used for correlation correction is:Y = a X + b

Where, Y is the corrected result


X is the actual result obtained on this analyzer
a is the multiplication correction factor
b is the offset correction factor
When the results obtained on this analyzer are as expected feed
a = 1 and b = 0.
The following plot shows the relation of results obtained on any two
compatible analyzers:
(Here b = 0 and a = 1)

However, when there is a difference in the result between two machines,


correlation correction factors a and b can be calculated and fed to obtain
consistent results on both the analyzers.

Correction factor a, should have values between -999.9 and 9999.9 while
correction factor b should have values between -99999.99 and 99999.99.

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Reagent Abs Enter the minimum and maximum absorbance values of the reagent.
Min and
Reagent Abs Reagent ABS is checked while running Blank during
Max calibration, if RgtABS value is non-zero for the test in Test
Parameter.

This check is applied for flagging only if RgtAbsMin > 0 for decreasing
direction or RgtAbsMax > 0 for increasing direction in Test Parameter.

Compare the ABS received after adding reagent, say A1 (for 1 Reagent
chemistry, ABS after adding R1 & for 2 Reagent chemistry, ABS after adding
R2) with the Rgt ABS value entered in Test Parameter.

For Decreasing Direction - If A1 (ABS) < RgtABSMin then attach Flag


“RgtAbsMin” to the Blank results.
For Increasing Direction - If A1 (ABS) > RgtABSMax then attach Flag
“RgtAbsMax” to the Blank results.

This check is applicable to -

Patient and control results for only single reagent chemistry.

Blank for single and dual-reagent chemistries.

6.3.5.1.2 Auto Rerun

Tick this check box to set the auto-rerun for a test with appropriate dilution of sample.

Use SET AUTO RERUN button to set the auto rerun for multiple tests.

Click on the desired option to choose Selective test or All test(s) for auto rerun.

If Selective is selected then user can select test(s) from the list below for setting auto-rerun by
clicking on the boxes in the front of tests. Then click on OK button.

If All test(s) is selected then automatically all the tests in the list below will be selected for auto
rerun. Click on OK button to save and apply settings. Click on CLEAR button will close the window
without saving changes.

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Before selecting the tests for auto rerun, specify the increase and decrease sample volumes for the
test in Test Volumes screen. See Test Volumes for more details.

When auto rerun for test is selected, patient sample will automatically re-run (performed again) on
occurrence of specific flags to the result.

You can set the flags for rerun in Rerun Flags screen, as per your requirement.

Auto Rerun is also selected from PRE-RUN options in Status Monitor screen.

6.3.5.1.3 Copy Test

This button is used to copy the test parameters from one test to another.

To copy, select the required test from the Test panel, and click COPY TEST. Enter a new test name
and click OK. The new test name will be displayed in the Test panel.

Newly copied test will be displayed in Setting > Test Sequence > TEST PROCESS SEQUENCE
based on Open / Closed reagent type.

This button is disabled during run.

Copied test will not display the revision number.

It is allowed to copy only permitted number of open channel tests (user defined),
after that system will prompt a message.

6.3.5.1.4 Upload and Download Tests

Upload button is used to upload the default test parameters and Download button is used to
download the default test parameters in a excel file.

See the following section for more details:

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Upload Test

Using UPLOAD TEST button, the parameters of the selected test gets uploaded.

Default tests parameters are updated through ENC file format only.

Default test parameters are available in the software CD.

Before uploading parameters for a Default test, make sure that respective test is available in the
tests panel. In case, if test is not available or deleted, it will automatically add the respective
parameter after user confirmation. See the following figure:

Whenever the parameters of the default test are updated using UPLOAD TEST, the revision
number will also get updated.

While updating default Test Parameter from Upload Test Option, if Curve Type changes from
Linear to Non-Linear or vice versa, then Application will ask for user confirmation.

Upload Test for default parameters, overwrites the weak parameters (user editable parameters)
and Reference Ranges only after user’s confirmation.

To upload parameters with different units, select option Overwrite Weak


(editable) Parameters, and then click on Yes. This will upload the
appropriate units and limits.

It is recommended to select option Overwrite Existing Reference Ranges,


while uploading.

After uploading the test parameters, make sure that correct parameters got
updated by verifying version number in the test parameter (which should
match with the version number of kit insert).

The UPLOAD TEST option will be disabled for the ISE tests

Download Test

Using DOWNLOAD TEST button, the parameters of the selected test are stored in a xml file and
saved in the C:\MultiXLLOG\DOWNLOAD PARAMETERS. A reagent distributor/manufacturer
may enter a new test from test parameter screen, download parameters and send the xml file to
distribute parameters to their customers.

The DOWNLOAD TEST option will be disabled for the ISE tests.

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6.3.5.1.5 Initialize Tests

This button is used to initialize the test parameters from existing ones to default settings. The tests
with similar test names are replaced from default ones and the newly added tests are retained as it
is.

To initialize test parameters, click on INITIALIZE TEST(S) button, select the test(s) to be initialized
and confirm by clicking on OK button. After successfully initializing the tests, following message will
be displayed.

Host Name will not be altered on initialize.

6.3.5.1.6 Special Diluent

Some test chemistries requires special diluents for example HbA1c. Select this option, if any of the
selected tests requires special diluent.

Special diluent is defined through the Consumables screen and its position assigned through Utility >
Reagent Positions screen.

When Special Diluent/Reagent is not available on-board, user can either stop run or mask test and
proceed run

6.3.5.1.7 Test Specific Special Diluent

Follow the steps to use Test-specific Special Diluent for an Open / Closed Channel Photometric
Test:

1) Click Consumables from Master.


2) Select Consumable Type > Special Diluent from drop down list.

3) Click Consumable > as shown in below screen

4) Define different test-specific diluents to be used during run and click Save.

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5) Go to Test Parameters > Test Details


6) Select the test from the Test panel list.> Edit.
7) Select (tick) Special Diluent. List of Special Diluent will be available for user to select from
available special diluent. Select the Special Diluent from the drop down list.

8) Also by using Special Diluent > Click , user can edit special diluent for test as shown in
below screen.

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9) Select the test and Click EDIT. Select the Special Diluent Name from drop down list as show
below

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10) Click Save.


11) For the Test, if Test specific special diluent is selected, Test Details screen will be displayed as
below

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If Special Diluent is selected in Test Parameter >Test Details for the particular
test, and test specific special diluent is not defined (**Any** is selected) then any
consumable available under special diluent category will be utilized during
RUN.

6.3.5.1.8 Cuvette Wash

This check box is used to provide a cuvette wash with special wash solution, after performing the
test. This wash is recommended if you are performing special tests like HbA1C, IGG, IGE etc.

The tests for which cuvette wash checkbox is selected, it will be referred to as test requiring cuvette
wash.

Any tests for which the option ‘Cuvette Wash’ is selected, such tests will never
use cuvette#1, during run. Those tests are performed in the next available
cuvettes. During this process, it is indicated by a message ‘SKIP’ in the
progress of the measurement table in Status Monitor.

Ensure that the special wash solution is defined (through Consumable screen).
Once defined, go to the Utility > Reagent Position screen, and define the
position of the special wash solution in the reagent tray.

The cuvette will be washed with special wash solution (different from the wash solution used for probe
wash); after performing the tests requiring cuvette wash. The special wash solution is common for all
the test(s) requiring Cuvette Wash and is not test specific.

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In case, special wash solution is not available during run then the cuvettes
requiring wash with special wash solution will be skipped and Progress bar of
Status Monitor will show NSWS (No Special Wash Solution).

6.3.5.1.9 Warn After

This text box is used to displays the low reagent warning message for the selected test, during run.
User needs to enter the number of possible tests on which he requires the warning for the reagent.

If the possible number of tests on board for a particular reagent bottle is less
than or equal to the limit entered in this parameters, then it will display the low
reagent volume message with position number in ERROR MESSAGE grid in
Status Monitor screen.

Enter the number between 0 and 200. Default value will be 20.

If this text box is left blank, then 0 (zero) value will be saved and it is considered as warning for low
reagent volume is not required for that particular test.

6.3.5.2 Test Volumes


Test Volume screen is used to perform the following operations:

To specify normal, increase and decrease sample volume

To specify reagent volume and stirrer speed

Copy and view sample volumes

Applying Normal Dilution Ratio of Sample

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It displays the sample and reagent volumes for a test along with the sample type. It also includes an
option of copying the sample volumes if the SERUM, URINE, CSF, WHOLE BLOOD, PLASMA and
OTHER sample types share the same volumes as Serum sample type.

The user needs to select a sample type prior to defining the Sample, Standard and Reagent Volume
for a test. The Sample and Reagent Volumes may vary for different sample types. However, the
Standard volume remains the same for all sample types.

During calibration run, standard volume of Sample Type ‘Serum’ is read for the
respective test is used.

6.3.5.2.1 Sample Volumes Parameters

This table describes the description of each parameters:

Parameters Description
Normal Specify normal (or default) sample volumes depending on the selection of
sample type.
Increase Specify sample volume (higher than normal) to carry out an automatic rerun of
the sample in case of a hyperactive sample or when the Sample is requested
as increase in the Patient Entry screen.
Decrease Specify sample volume (lower than normal) to carry out an automatic rerun of
the sample in case of a low reactive sample or when the Sample is requested
as decrease in the Patient Entry screen.
Standard Specify volume to be used for calibration that is Blank, Standard and
Volume Calibrators.
Dilution Ratio Specify the dilution ratio for normal, increase and decrease sample volume.

A dilution ratio Nx means 1 part of sample and (N-1) part of diluent.

6.3.5.2.2 Reagent Volume and Stirrer Speed

This table describes the description of each parameters:

Parameters Description
RGT-1 Volume Specify volume of reagent to be aspirated for Reagent 1.
RGT-2 Volume Specify volume of reagent to be aspirated for Reagent 2.

This parameter will be displayed for 2 reagent test.

R1 Stirrer The mixture of reagent and sample are mixed by stirrer at three fixed speed that
Speed is Low, Medium and High, as appropriate.
R2 Stirrer The mixture of reagent and sample are mixed by stirrer at three fixed speed that
Speed is Low, Medium and High, as appropriate.
This parameter will be displayed for 2 reagent test.

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6.3.5.2.3 Copy Volume

Copy Volume button is used to copy the volumes from current sample type to other sample type(s)
of the selected test.

Use DELETE button, to delete the sample type.

Default sample type of a default test can not be deleted. Delete button will be
disabled.

View Volume button is used to view the volumes programmed as per the different sample types.
Use HIDE VOLUMES button to go to previous screen.

6.3.5.2.4 Apply Normal Dilution Ratio of Sample

Tick this option, if you want to pre-dilute standard/calibrators using normal dilution ratio of Sample.

It is available for photometric tests only.

6.3.5.3 Reference Ranges


Reference Range is used to define the normal ranges and panic limit values for the patients for
category such as Male, Female, Child, Other.

It is also used to copy the reference ranges of one sample type to different sample types for the
selected test.

Depending on the reference range selected the Normal Ranges for Male, Female, Child, or Other
would be used accordingly to generate the H and L flags.

You can define reference range through Master menu. See section To add reference range for more
details.

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This table describes the description of each parameters:

Parameter Description
s
It displays the test as selected from the Tests panel.
Test

It displays the sample type as selected from the list of available Sample Types.
Sample
Type

This drop down list contains different age groups, in addition to DEFAULT. Select
Reference
appropriate age group to define the normal range and panic limits. To add a new age
Range
group, see section To add reference range for more details.
This drop-down list is used to select the category (gender). The available options are:
Category
Default, Male, Female, Child, and Other.
Define the expected values or normal range for Serum/Urine/Other samples being
Normal
assayed. These limits are used to issue H or L flag, which indicate a higher
(Lower
concentration than normal or lower concentration than normal respectively.
Limit and
Normal Normal range values for both Male and Female subjects can be specified for two
Upper different age groups. Additionally, default normal range values can also be defined for
Limit) Male, Female, Child and Other subjects.

The default normal range is used if the age of the patient is not known.

Use this to enter the expected values range for different sample types for different
assays.

For correct H and L flags, the patient’s Category and Gender should
be set before the patient’s sample is analyzed.

Panic Define the minimum and maximum concentration limits for results which are unusual
(Lower and enough, requiring special review by the technician. These values are the upper and
Upper lower panic value limits for specified tests.
Limits)
When the sample result violates the Panic Limit Minimum or Maximum, a flag PANH
or PANL is issued with the result respectively. It is recommended to recheck such
result by repeating the test before reporting.

An automatic rerun of the patient sample, to repeat the test due to Panic Limit
violation, will be performed if:

Auto rerun option is selected for the respective test in Test Details screen

Rerun flag is selected for PANH and PANL in Rerun Flags screen

Auto rerun option is selected from PRE-RUN Options in Status Monitor screen

When PANH or PANL flag is issued to a result of patient sample, the "same" (re)run
will be performed. A same rerun means using the sample volume same as it was
programmed in the first determination.
For example, if the sample was programmed for a normal volume run then the rerun
too will be performed using normal sample volume.Similarly, if the sample was

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programmed for Decreased or Increased volume run, then the rerun will be performed
using a Decreased or Increased volumes respectively. The rerun result is flagged “#” to
indicate a rerun.

6.3.5.3.1 Copy Reference Range

This button is used to copy the reference ranges from current sample type to other sample types.
Multiple sample types can also be selected.

6.3.5.3.2 View Reference Range

This button is used to view the reference ranges programmed as per the different sample types. Use
HIDE REFERENCE RANGES button to go to previous screen.

6.3.5.4 Profiles
Profiles screen is used to create test profile. Profile is a predefined group of tests.

Once created, they are used for selection through a single click, during the patient entry details in
the Patient Entry. One or more profiles can be selected for a patient at the same time. See section
Create Profile.

6.3.5.5 Calculated Items


Calculation item screen is to define a calculation item involving one or more chemistries (up to 5
chemistries). It is also possible for the user to define the formula as per your requirement using the
Calculation Formula screen.

If these calculation items are selected in the Patient Entry screen, then the test(s) required to
calculate the value are selected (scheduled) automatically. The calculated items are printed along
with the test result in the Patient Report printout.

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This table describes the description of each parameters:

Parameters Description
Calculated Define the name of the calculated item, up to 5 characters. This name will be shown
Item in a separate grid in Patient Entry screen.
Report Enter the full name of the calculated item (i.e., A/G ratio). This name is printed on the
Name patient report.
Formula The user can select the desired calculation formula from the drop down list. If new
formula is required, you can create your own formula using Calculation Formula
screen.
Unit Select the unit to be printed along with the calculation Item.
Host Name Enter the name of the calculated item, as defined in LIS (for host communication).
This text box is visible only if Host connection is activated from System Parameters
screen.
Decimal
Enter the number of decimal places for the calculated item.
Places

Once, the formula is selected, the user can select the tests associated with the
calculation item. Additionally, the user can also use another calculation item (nested
calculation items) for defining a new calculation item.

The user can select the normal ranges or panic limits (if desired) for the calculation
item depending on the sample type selected. Normal Range options are available for
Default, Male, Female, Child or Other types.

CEC Calculation item is present by default. For this calculation item, only the Report

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Name, Unit, Decimal Places and Normal Ranges can be modified. Test A can also be
selected and Test B will be displayed same as Test A.

If CRE is deleted from the test parameters screen, then CEC is not visible in
calculated items.
When CRE is again initialized through the test parameter screen then a
Activate CEC button is displayed on the Calculated items screen. On clicking,
CEC is again visible in the Calculated Items.

6.3.6 Utility
Utility allows user to perform the following operations:

Defining reagent bottles in different positions on reagent tray.

Taking full and selective database backup

Printing offline patient report

Recalculate results after result analysis

Utility consists of following screens:

Reagent Positions

Backup

Offline Results

Recalculate

6.3.6.1 Reagent Position


Reagent Position screen is used to define reagents bottles manually on Reagent Tray and view to
reagent details after reagent barcode or level scan.

To define reagent bottle manually, see section Defining Non Barcoded Reagents for more details.

If the reagent bottles are bar-coded, then they do not need to define positions as they are
automatically updated and displayed after the Reagent Barcode Scan. Reagent volume will be
updated automatically when the Volume Scan is performed through Status Monitor.

Also, using this screen you can also edit or clear the defined reagent positions.

See the following screen:

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See the following screen option in details:

Clear position :Clear Position used to clear the defined reagent positions on the reagent tray. There
are two sub options:

All: To clear all the position on the reagent tray

Selective: To clear the specific position on the reagent tray.

Edit Position :Use this option to add or alter the reagent definition at a specific position.

Refresh Positions :This option is used to notify the availability of reagent in the reagent bottle(s) at
All or Selective positions on the reagent tray. During run, while aspirating the reagent, when a
reagent bottle is detected as empty bottle (no volume) then such reagent position is de-activated and
not used for further aspiration of reagent. Replace the empty reagent bottle on the reagent tray with
the filled reagent bottle. Then use this option, to notify the reagent availability to the system.

Scan pack: This option is used to scan the details of System Pack Reagent kits for Closed channel
reagents. Refer section Scan Pack for more details.

Transfer To Tube: This option is used to utilize tube by transferring reagent from scanned barcoded
reagent bottle to tube. For details refer section Transfer To Tube

Keys – Empty Bottle and Expired Lot: These keys indicate the meaning of the white and red
background color used for the rows of the positions grid displayed in the screen.

Empty Bottle: When a row is highlighted with white background color, it indicates that the
reagent volume at that position has become zero during run.

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Expired Lot: An expired reagent lot on the reagent tray is highlighted with red background
color. The expired reagent is not aspirated during run. However, volume scan will be performed
for the position(s) having expired lot.

Expiry date of reagent bottle is compared with batch run start date, to decide
whether or not to aspirate the reagent during run.

Discarded: When a row is highlighted with dark orange background color, it indicates that the
reagent bottles at that position are discarded. It will be displayed after performing volume scan.

Expiry date of reagent bottle is compared with batch run start date, to decide
whether or not to aspirate the reagent during run.

The parameters in the grid are shown below:

Parameters Description
Position Reagent positions on Reagent Tray.
Reagent Reagent name.
Type Reagent type (R1/R2).
Bottle Type Bottle type of the reagent (Large / Small / Tube).
Rgt Vol (ml) Reagent volume scanned (ml).
Lot No. Lot number of the selected reagent
Expiry Date Expiry date of reagent as defined in consumables / read from barcode
Barcode Barcode label read on Reagent Barcode Scan.
“-“in this column indicates manual definition of reagents.
Stability inboard stability period as defined in consumables.
Unit Unit of the stability period, hours/days as defined in Consumables.

6.3.6.2 Transfer To Tube


Transfer To Tube option is used to allow tube in place of scanned barcoded reagent bottle.

Use “Transfer to Tube” option before starting the batch run..


During run, this option remains disabled.

Procedure for Transfer To Tube:

1. Scan barcoded reagent bottle from which you want to use reagent in the tube. Analyzer will get
details of reagent bottle on scan.
Barcode scan of each reagent bottle is required ONLY ONCE.
Ensure, the reagent pack from which you removed the bottle, is already scanned with
Test Loader Device.
2. Once barcode is scanned, fill the reagent into tube from scanned barcoded bottle only.
3. Place this tube at the place of same bottle position.

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4. Click Utility > Reagent Position > Transfer To Tube.

5. Select the scanned reagent bottle position from which reagent to be transferred to tube.
6. Click Transfer To tube. Reagent position box appears.
8. Select the reagent position and Click OK.
9. Do not keep the same reagent (in bottle/tube) at multiple positions in reagent tray. In case, same
reagent is kept at multiple positions following message will be displayed.

Clear the other alternative position.

10.Click OK. Click Reagent position, reagent which is transferred to tube now appears in bottle
type as Tube.

11.Ensure sufficient reagent in tube to complete the run. If reagent is not sufficient then fill the tube
from same reagent bottle ( scanned in step 1 ).
In case scanned reagent bottle is over, scan another bottle from same system pack, follow the
procedure for Transfer To Tube to continue run.
In case all bottles of same system pack is consumed, scan new system pack ( Refer section
Scan Pack for more details ) and then follow the procedure for Transfer To Tube to continue run.
12.Start the RUN, analyzer will use reagent from tube to complete the run.
13.Before starting the next batch RUN, check if reagent in tube is sufficient to complete the run
otherwise fill the reagent from earlier scanned bottle into tube and start run.

Alternate, Expired and Discarded bottles of selected Reagent/Test will be


treated as Multiple Bottles and will be cleared during barcode scan.
If bottle associated with Tube is discarded then barcoded bottle of same
reagent on other positions will not be cleared.

Once Transfer To Tube is saved it cannot be reverted (it will be displayed in


Grey color)

If user wants to deselect this position then use either Clear Position option or
can keep any barcoded bottle on that position so that respective tube position

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will be replaced by barcoded bottle after barcode scan.

Reagent Barcode Scan (Offline/Pre-Run/Add Reagent during run)

After Reagent Barcode Scan, Reagent Position marked with Transfer to Tube will be retained
across the batch till user either manually modifies the position or scans bar-coded Reagent bottle
on that position.

During Volume Scan

During Volume Scan, like bottle; when Reagent Absent, VOD or Liquid Level found different etc. is
reported then add respective tube Position to Refresh List; such that Tube is not used till user
refreshes the position (after taking appropriate action like fill tube from respective scanned bottle,
remove froth/bubble etc).

Track Reagent in Tube During RUN

System will track reagent volume used in tube for new as well as used reagent bottles.

System will report reagent absent based on volume availability.

If reagent volume in bottle is over, then associated bottle gets discarded.

Tube is not allowed for discarded reagent bottle, until next barcoded bottle is scanned.

6.3.6.3 Backup
Backup screen is used to take the backup of the patient database and to copy data to external
storage device.

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Backup consists of following options. See for more details:

Backup Operations

Copy Data to External Storage Device

System Backup Restore

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6.3.6.3.1 Backup Operations

Backup Mode: The display changes according to the selection and provides necessary guidance to
perform the operation.

Two options are available. Full Backup and Selective Backup. Only full backup is re-storable.
Selective backup is used to extract partial data for reference and cannot be restored back.

Backup Format: This drop down list is used to select the Mode of Backup. Available options are
Text, XML, XLS, and CSV. These options are available if the Selective Backup option is selected.

XML: This mode of backup stores the Backup Parameters in XML format

Text: This mode of backup stores the Backup Parameters in Text format

XLS: This mode of backup stores the Backup Parameters in Excel format

CSV: This mode of backup stores the Backup Parameters in Excel format.

The option Database will be displayed if Full Backup option is selected. Using this option, a backup
file of complete database is created in .BKP format along with .ARH file (.ARH file is a full backup of
Archived data).

Backup Path: Click on the Browse button to select the path or directory where the Parameters will
be backed up. It is not recommended to take the backup on the desktop.

Database: This mode of backup copies the entire database and stores it on the hard disk at the path
selected by user using Browse button.

Backup Option: A list of parameters is available for Backup if the user selects the Selective Backup

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mode. The user can either check all the parameters using Backup Option/All check box or make a
selection individually using the checkbox placed against each parameter.

After the above operations have been done, click on Backup button to take a backup of selected
parameters.

Take Full Backup periodically, to avoid loss of data in case of PC crash.


Store the backup file .BKP, created through Full Backup; in an external media
like CD/DVD.

6.3.6.3.2 Copy Data to External Storage Device

The option is provided to copy database backup, log files and exported report files on USB storage
device.

To copy data to USB storage device, log in as Admin (windows user login) and run MultiXL.

Procedure to copy data on USB storage

1. Login as Administrator on the analyzer PC and start MultiXL software.

2. Insert the USB device.

3. Select Utility and click on Backup screen.

4. Following options are available to copy data on USB storage device. Select any one, as
appropriate:

Only Database: Database full backup, .bkp file will be copied to USB.

Only Log Files: Copy log files from the location C:\MultiXLLOG into USB device.

Both Log Files and Database: Both, Log files as well as Database as per specified
date, will be copied to the USB device. Following options are visible on selection.

Full

Analysis Data Required for Date

Folder To External Drive: The folder (along with its contents) selected from the
analyzer PC, termed as Source Location, will be copied to the USB device.

Exported Reports: System will copy all exported reports (present in designated folder
on hard disk drive) like Result Reprint, Test Statistics etc. to USB device.

Exported Reports: System will copy all exported reports like Result Reprint, Test
Statistics etc. to USB device.

5. User can select any one of the above options and select the Destination Location i.e. the
USB device. Following message will get popped to select destination location

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6. Click the Copy Analysis Data button to copy data based on user selection.

7. On completion of data copy, message will be displayed as “Analysis data copied to the
destination location successfully” in the indication panel.
6.3.6.3.3 System Backup Restore

System Backup Restore option is provided to take backup of setting files and database on any other
D / E drive (auto drive selected by system) except from the C drive.
System Backup will be taken on MultiXL Shut Down. After taking weekly backup, old database
backup will be removed from c:\MultiXLLOG_Backup
User can also take system backup manually by following steps;

1. Click Utility > Backup >


2. Go to System Backup Restore

3. Backup Path is selected by the system.

4. Click on to take backup of setting, log and database files.

5. To Restore the files user needs administrative rights otherwise Restore button will remain

disabled . See Section User Rights for more details.

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6. Run Database Utility to restore the backup of database. Refer section Database Utility Options

6.3.6.4 Offline Results


Offline Results screen enables user to enter data for any patient without having to actually perform a
test on analyzer. In this case, the application software is simply used to print the patient report. See
the following screen:

In case, if the result is entered for the test(s) that is available in test parameter then the result will be
saved with decimal places as defined in test parameter for the respective test. When the result is
entered for a new test i.e. for test that is not in test parameter; then the result will be saved with
decimal places as entered.

A description of the available parameters on this screen is as follows:

Item Description
Select the date for the patient result. It will always display the current date
Date
by default.
By clicking on the dotted button, select the name of the Laboratory from
Laboratory
the available list. Use Master > Laboratory screen to add a new laboratory.
By clicking on the dotted button, select the name of the Instrument (from
Instrument the available list) on which the test is conducted. Add a new instrument
name from Master > Instrument screen.
By clicking on the dotted button, select the Sample ID, if already defined
Sample ID
from Patient Entry screen or directly enter the sample id in this textbox.

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Sample Type The user can select the Sample Type from drop down list.
Enter the name of the patient. The name of the patient will be displayed
Patient Name
automatically if the Sample ID is selected from the dotted button.
Age It displays the patient’s age..
Category This list displays the Category (Gender) of the patient.
Select the required test name from drop down list or enter a new test name
Test
up to 5 characters.
Report Name Enter the Report Name of the selected test, for printing in Patient Report
Unit Select / enter the Unit of measurement for the test.
Normal Lower Limit Enter the Lower Limit of the Normal Reference Range for the Test. By
default, the reference range will be displayed when the test available in
Test Parameter is selected from the list of Tests.
Normal Upper Limit Enter the Upper Limit of the Normal Reference Range for the Test. By
default, the reference range will be displayed when the test available in
Test Parameter is selected from the list of Tests.
Result Enter the result for the Test.
Flag Enter the Flag associated with the Result.

On clicking PRINT button, the patient report will be generated. This result can also be printed from
Reports > Patient Report screen along with other results of the patient.

6.3.6.5 Recalculate
Recalculate screen is useful in recalculating results if any changes are made in the test parameters
or calibration data after analysis. This is particularly useful because one does not have to rerun a
sample if a mistake was made in test parameters or the calibration table.

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Recalculate screen is not available during batch run.

Results of deleted sample IDs cannot be re-calculated.

Results of the test(s) having flags for Sample/Reagent absent cannot be re-
calculated.

To obtain recalculated result:

1. Select Result Date or Batch number or Test or Sample ID.

Sample ID textbox will be disabled if option Calibration or Control radio button is selected.

2. Select Patients or Calibration or Controls, as appropriate.

3. Click on SHOW button to view all the results.

4. Select the result(s) for which re-calculation is required. Click on the Recalculate button. The
re-calculated result and flag (revised as per re-calculated value) are displayed along with the
original result and flag.

5. Recalculated test results can be sent to Host by selecting the results and clicking on the
Send To Host button.
.
Send To Host button will be available if:

Patient or Control option is selected for showing results.

Host Connection option is activated in System Parameters screen.

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During run, the Send to Host button is not available in the Re-calculated screen
and Result Reprint screen.

The option ‘Ignore Limits to Re-calculate Results’, allows user to display the
recalculated result with ignoring limit flags.
If this option is not selected, NA will be displayed in the Result column.

6.3.7 Maintenance
During Maintenance activity when dome is open ( Level 1 and Level 2 ), then
following warning message with alarm beep will be displayed and error
message will be reported in error display grid.

Maintenance consists of following screens. See for more details:

Maintenance

Cell Blank

Maintenance Log

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During Run, the Maintenance screen is disabled. User can access this screen
only after completion of the ongoing Batch Run.

After completion of Start-Up Maintenance activity, User will get intimation of


completion of Auto Maintenance activity.

ISE operations on Maintenance screen remains disabled when there is no


communication between analyzer and PC.

6.3.7.1 Maintenance
Maintenance is used to perform the routine maintenance of the analyzer.

See the following sections for more details.

Span (Auto and Manual)

Wash

Dead Volume Calibration

Auto Maintenance

6.3.7.1.1 Span (Auto and Manual)

Auto Span : This option is useful to view and adjust the photometer gains at different wavelengths.
The analyzer adjusts the photometer gains automatically, if you select Auto Span option, and click
on START button.

If the gain obtained during auto span is within the factory set limits, it is indicated by a green
background. And if the gain is not within the limits, then it is indicated by red background.

The photometer gains can also be adjusted manually, however it is not recommended.

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If the absorbance of the DI Water placed in front of the cuvette is not between
0.05-0.085 Abs, then following corrective measures should be taken.

Check the cuvette

Perform cuvette rinse to ensure that the cuvettes are clean

Check the particular wavelengths and the photometer lamp

Call the service engineer

The Auto Span option will be the default option when the Maintenance screen is
clicked first time. Later it can be change, as appropriate.

Manual Span: This option is useful to view the absorbance and voltages at different wavelengths. It
is also used to view the photometer stability at different wavelengths.

Use the following procedure for using manual span:

1. Select the required wavelength using which the absorbance and voltage needs to be checked.

2. Select the appropriate cuvette number from the Cuvette No. drop down list.

3. Click on Start button.

4. The continuous online update of voltage and absorbance takes place and is displayed on the
screen.

5. Click on Stop once the check is performed.

6. User can select another wavelength to check the voltage and the absorbance at the other
wavelength. Again user needs to click on Start to start the reading and Stop to stop the
reading.

6.3.7.1.2 Wash

Use the following wash maintenance commands.

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See the following wash commands in more details:

Prime Wash

This option is used at the beginning of the day before the Cuvette Rinse operation. The syringe
valve of the Probe is kept ON (depending on the time set by the user: Max time is 5 minutes) to
remove the air trapped inside the tubing. Also, the valves of the CRU tubing are kept open to
remove the air trapped in them. The following operation occurs after the button is clicked:

1. Machine Initializes.

2. CRU1 go in DOWN position in the RCT.

3. The syringe valves for CRU and Probe open sequentially.

4. The priming continues for “x” minutes.

5. After the priming operation is completed, the CRU initializes to home position.

Cuvette Rinse

On selecting this option, the user can perform a cuvette wash of all 45 cuvettes by clicking on the
START button. This wash is done using DI Water. At the end of Cuvette Rinse, the cell blanks are
updated automatically and can be seen by clicking on the Maintenance > Cell Blank screen.

Water Save

This option enables the operator to wash the reaction tray cuvettes with some cleaning solution
and fill all cuvettes with DI water at the end of a day’s work or at beginning of the day.

This operation can be performed any time using Water Save option.

To perform this, select Water Save, and click Start.

On clicking this button, the analyzer first washes all the 45 cuvettes with the cleaning solution
through laundry probes, and then using the Arm probe, the analyzer fills DI water in all the 45
cuvettes. This water remains in the cuvettes until the next run or cuvette wash/rinse.

Overnight filling of the cuvettes with DI water is helpful in loosening the dirt on the cuvette walls.
Perform water save daily, at the end of the day’s work.

Poor quality DI water should not be used for Water Save, as bacteria growth
can take place inside the cuvettes.

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Auto Wash

The cuvettes, arm probes, and stirrer can be cleaned with external detergents or cleaning solution
through Auto Wash option.

Usually, the Auto Wash AC (Acid) or Auto Wash AL (Alkali) cleaning solution is used for this
operation.

It is recommended to perform this procedure once a week or when needed. If one is using latex
based assays regularly, it is recommended to perform a Cuvette Wash daily with Auto Wash AC
(Acid) or Auto Wash AL (Alkali) cleaning solution.

However, any other cleaning solution with appropriate concentration can be used for this
operation. These solutions are not kept in the detergent Can but in reagent bottles on the Reagent
Tray and in sample tubes on the Sample Tray.

Auto Wash option can be used instead of Cuvette Rinse option, when operator wants to use
external detergents/solutions to clean the cuvettes, probe, and stirrer.

Use 0.1N HCL for AC(Acid) and 0 .1N NaOH for AL(Alkali) to perform Auto
Wash.

Before starting the auto wash, you need to specify the cleaning solutions in the appropriate
position on the Sample Tray and Reagent Tray. See the following procedure.

1. Place 18 ml of Auto wash AC (Acid) Wash Solution at reagent position 1 and Auto Wash
AL (Alkali) Wash solutions at reagent positions 3 on the reagent tray (in 50 ml large
bottles).

2. Place 200 µl of Auto wash AC (Acid) Wash solution at sample position 1 and Auto Wash
AL (Alkali) Wash solutions at sample positions 3 on the sample tray (in 2 ml Cups).

3. Click on START button.

4. On clicking, a message box will be displayed indicating the user for placing cleaning
solution.

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5. Click OK to perform auto wash.

If you want to stop the operation, you can click on the STOP button that is active after
the start button is clicked.

The following buttons will be displayed after performing the auto wash operation:

SHOW REPORT: This button will display the list of dates with time on which the auto-wash was
performed.

EXPORT: This option is used to download and save the auto-wash history in excel (.XLS) file in
location C:\MultiXLLOG.

It is recommended to perform the Auto Wash once a week or when needed.


If the user has not performed auto wash for 7 days, then on the next day,
MultiXL prompt the user to perform Auto Wash by displaying a pop-up
message on the right-bottom corner of the Status Monitor screen after first
batch run of the day.
Reminder pop-up will stays on screen, till user click on Close button.
This will be displayed once in a day.

Probe Wash

This option enables the operator to wash the probe with Auto Wash AC (Acid) or Auto Wash AL
(Alkali) cleaning solution at the end of a day’s work or at beginning of the day. This operation can
be performed any time using this option.

Follow the steps performed for probe wash.

1. Select the desired number of cycles from 01 – 09.

2. Click START button.

On clicking, a prompt window will be displayed for the user to enter/confirm the position of
the wash solution on the reagent tray.

In case, if the wash solution is already defined through Utility > Reagent Position, on
clicking START, the prompt window will displays the position number where the wash
solution is defined. You can edit the wash solution position by entering new position

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number. Refer figure below.

Enter the wash solution position, and click OK, the Probe picks up the appropriate
volume of wash solution (in µl) and dispenses it in the drain with internal and external
cleaning.

The Probe wash action is repeated based on the number of cycles selected.

3. After the action is completed the analyzer gets initialized.


6.3.7.1.3 Dead Volume Calibration

This screen used to calibrate the Dead Volume for Sample Containers and Reagent Bottles. This
procedure should be carried out at time of software installation (application or analyzer embedded).

This procedure should be carried out only once.

Use the following procedure to carry out the dead volume calibration:

Reagent Bottle Calibration

The following steps should be performed to carry out the Sample container calibration:

1. Select the appropriate Reagent bottle type available from the SELECT CONTAINER TYPE
list for Dead Volume Calibration.

2. Pipette the exact amount as defined for reagent bottle in Calibrate with Volume .

3. Place the reagent bottle according to the bottle type on the position specified in the list.

4. Click CALIBRATE button.

If the reagent volume present in the specified reagent bottle is not approximately equal to
the volume with which it is to be calibrated, then message “Calibrated Value Out of Range
of Specified Value” is displayed.

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Once the calibration process is completed, a message is displayed whether the


calibration is successful or failed.

If the calibration is successful then the values are automatically stored in the software.

Sample Tube and Cup Calibration

The following steps should be done to carry out the Reagent Bottle calibration:

1. Select the appropriate Sample tube available from the SELECT CONTAINER TYPE list for
Dead Volume Calibration.

2. Place the containers according to the container type on the position specified in the list.

3. Pipette the exact amount of volume as defined for sample tube in Calibrate with Volume.

4. Click CALIBRATE button.

Once the calibration process is completed then it is automatically stored in the software.

During calibration, if assembly error occurs; then the error message


“Dead Volume Calibration Failed” will be displayed on the error
message grid.

Default Calibration

The following steps should be done to reset the Dead Volume Calibration to Default:

1. User should click on DEFAULT button.

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2. Select the container type from the list for which the Dead volume calibration needs to be
reset.

3. User can click on OK to reset the selected containers.

If the Application Software is changed, then the Dead Volume Calibration


settings are updated automatically and it can also be updated from the
instrument from Service Check > Read Current command. If any hardware
program is changed, then the Dead Volume Calibration should be repeated
again.

6.3.7.1.4 Auto Maintenance

By default, the auto maintenance start-up actions are performed automatically at the beginning of the
day when the application is started first time. This is an automatic service action that does not
require manual intervention.

When starting the Auto Maintenance activity, if dome is open ( Level 1 and
Level 2 ) then following warning message with alarm beep will be displayed
and error message will be reported in error display grid.

Ensure to close dome properly before proceeding.

During Auto Maintenance when dome is open ( Level 2 ), ARM movement will
be stopped immediately when activity requiring ARM movement is still
pending and error will be reported in error display grid.

Remaining Auto Maintenance activity will be continued as arm movement is


already executed for these activities.

This operation can be initiated any time from the Auto Maintenance from the Maintenance screen:

The auto-maintenance at startup is initiated to perform automatically when the


analyzer and computer are turned on for the first time each day.

See the following procedure to perform auto maintenance and shutdown operation manually:

Initiate Auto Maintenance at Start-up

1. Select START-UP.

2. Click START.

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On clicking, the following window will be displayed.


.

3. Click OK to continue with the maintenance.

This will start the auto maintenance operation.

Service actions during auto maintenance at Startup

Startup

1. Priming of laundry unit and SRPT probe with DI water for one minute (automatic step).

2. Auto Span operation (automatic step).

3. Cuvette rinse operation (automatic step).

4. Perform priming of SRPT syringe for one minute (automatic step).

If an error occurs at any of the steps mentioned above, then;

1. Description of the error occurred is displayed with an option for user to


“Retry” or “Cancel” maintenance.
2. If the user clicks “Retry” then a re-attempt is made to continue auto-
maintenance and resume from the activity in which error was
encountered without repeating the previous activities that were
completed successfully.
3. Analyzer will reattempt to perform auto maintenance for 2 times. Failing
which, it will cancel Auto-Maintenance on Startup activity automatically.
ISE Pump calibration, when fails/not in range; is not re-attempted.
Description of errors occurred during auto-maintenance can be
viewed at a later date from Reports > Error Log screen.

Initiate Auto Maintenance at Shutdown

1. Select SHUTDOWN.

2. Click START.

On clicking, the following window will be displayed.

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Put the required amount of cleaning solution on the mentioned reagent and sample
position, and then click OK.

This will start the maintenance operation and the instrument will be shutdown once it is
completed.

Service actions during auto maintenance at Shutdown

Shutdown

1. ISE clean (only if ISE module is attached)

2. Analyzer initialization.

3. Volume scan of cleaning solution.

4. Cuvette rinse operation.

5. Probe cleaning with cleaning solution for 3 times.

6. Internal and External probe cleaning with DI water in trough for 3 times.

7. Probe cleaning with DI water for 3 times.

8. Water save operation

9. Shutdown

During auto-maintenance at shutdown, if any errors (such as VOD, Wash


solution absent, or Hardware related errors) are reported, then those error
will be saved in the MultiXL database which can be later viewed in
Reports > Error Log screen.

6.3.7.2 Cell Blank


Cell Blank screen enables user to view the cuvette blank absorbance values (obtained with in air or in
water during cuvette rinse) at any particular wavelength.

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This menu enables the user to view the cuvette blank absorbance values (obtained with DI water in
the cuvette) at any particular wavelength. The screen displays the cuvette blank for the requested
wavelength. Wavelength can be selected by the pull-down option provided on the left side of the
screen. Use navigation buttons to view the cuvette blanks for the next and previous wavelength.

The values on the cuvette blank value table display should be between minimum and maximum cell
blank range. In case if any wavelength is measured out of range, it is indicated in red color on top of
the screen. See the following figure:

There is also a GRAPH button available, through which the cell blank reading for particular
wavelength can be viewed in a graphical format. The cuvette blank table consists of three sections.

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Present abs: It is the absorbance of the cuvettes with de-ionized water measured after the last run or
Cuvette Rinse.

Previous abs: It is the absorbance of the cuvettes with de-ionized water measured after the second
last run or Cuvette Rinse.

All dirty cuvettes will be skipped and no sampling will be done in dirty cuvette.

Graph: On clicking GRAPH button, the user can view the absorbance in graphical format for the
required wavelength. To view the graph, you need to select the required wavelength from the Select
Wavelength drop-down list, and then select the appropriate graph type from the Type option.

Three options are available to view the graph:

Present: This option will displays the previous absorbance graph obtained for the selected
wavelengths.

Previous: This option will displays the present absorbance graph obtained for the selected
wavelengths.

Both: The comparison of both graphs (previous and present) can be viewed using this option.

The maximum and minimum acceptable value of the cuvette blank absorbance can be set in the
Settings > System Parameter menu. If the absorbance of the cuvette blank exceeds the set
maximum blank absorbance, then that particular cuvette absorbance is indicated by red font color.
On the other hand, if the absorbance of the cuvette blank is below the minimum acceptable
absorbance, then it is indicated by Blue font color.

The values on the cuvette blank value table display should not exceed 0.1 normally. Cuvette Rinse
and/or Auto Wash procedure from Maintenance must be performed, if the cuvette blanks are higher

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than the maximum limit. If the Cuvette O.Ds exceeds 0.2 Absorbance, the cuvette should be
replaced with a new cuvette or should be cleaned externally using fresh water. This procedure should
be done daily before starting the batch.

6.3.7.3 Maintenance Log


Maintenance Log screen is used to review the maintenance operations performed on the analyzer
within specific period.

Screen shows the list of maintenance activities performed during the selected period with details
such as its status, source from which the activity was initiated.

The system records details like which activity is performed on what date, what was its source, and
what was the status.

Maintenance logs are extremely useful for troubleshooting purpose, as they provide a record of all
activity performed on the system and may shed light on hard-to-spot symptoms.

System keeps records of maintenance performed on the analyzer. To view the list, Select date
range From and To.

List can be further filtered out according to Source, Activity and Status.

Source indicates the domain from where the maintenance activity is initiated. Sources can be
Maintenance screen, Shutdown screen, Application Start (start of application).

Activity indicates the type of maintenance operation performed.

Status indicates the status of activity, such as successful, unsuccessful, and performed.

A : Select the date range.

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B : Select the source from which the maintenance activity is initiated.

C : Select the type of maintenance activity.

D : Select the maintenance activity status.

E : Use Show for displaying records and Print to print maintenance report.

F : Click on the icon to view the list of error encountered during the operation.

6.3.7.4 Archive
The archive data is the process of moving patient results to separate data storage for long-term use
Data archives consist of older patient data which can be used for future reference, if required.

Data archiving improves the performance of (Live) database with the following key benefits.

Faster search of patient results

Quick accessibility of patient results

Reduces the amount of storage required for patient results.

For archiving and restoring patient data, select Maintenance from main screen--> Archive

Initially, when the software is installed, this option is not visible. It appears only when the patient
results reaches to a specific limit. In this case, at specific time interval, software automatically
prompts the user to archive the data when it is necessary. Thereafter, this option will be always
visible.
It is advisable to archive the older patient results to separate data storage.

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It is mandatory to archive the data before starting the batch run when the patient
result reaches a specific limit (software shows alert message, as required).

Only Patient results will be archived. The Calibration, Control and Consumables
data will always remain in the (Live) Database. While archiving the patient
results, the required additional information such as Area, Location, Doctor,
Reference Range etc are copied to the separate data storage (Archive Database)
and available while reviewing archived results.

This section includes:

Archiving Data

Viewing Archived Data

Observations

6.3.7.4.1 Archiving Data

Steps to follow the procedure for archive data:

1. Click on the Archive option from the main menu.

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archive Patient Data option, and click OK,the archive process will start and the
status will be displayed as shown below

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During the archive process, all other menus will be disabled.

4. After completing the archive process, a message “Archived data successfully” will be
displayed on the screen.

6.3.7.4.2 Viewing Archived Data

Steps to follow the procedure for Viewing Archive Data:

1. Click on the Archive option from Main screen Maintenance .

2. There are two options are available:

Archived List to View Reports

Archive Patient Data

3. Select the Archived List to View Reports option then select the desired archive to connect
to archive database to view the reports.

4. On clicking OK a message will be displayed “Connection successful. You may view the
Patient Reports”.

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During this time, only Reports, Search and Shut down menus are available. Rest
of the menus will not be accessible.

5. After connecting to achieve database, user will able to connect to Live database again by
selecting Live record from the list.

6.3.7.4.3 Observations

When the archive database is connected, the patient data can be viewed only in the following screen:

Reports > Patient Report

Reports > Result Reprint

Reports > Test Statistics

Reports > Error Log

Reports > Reaction Curve

Reports > Other > Reagent Consumption

Search > Patient Results

Other main menu screens are not accessible for the user except the following screens:

Search

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Reports

Archive

Shutdown

During batch run, the Archive screen will not be accessible.

6.3.8 Service
Only authorized technical service personnel should operate this screen.

The options in the Service Check are not accessible if any maintenance/batch
run operation is running through the maintenance/status monitor screen. In this
case, the status message highlighted will be displayed in yellow color on the
Current State field as shown below.

When starting the Service Check activity, if dome is open (Level 1 and Level 2 )
then following warning message with alarm beep will be displayed and error
message will be reported in error display grid.

Logout button is disable in Service.

This screen is used to perform the-- service related activities.

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See the following options:

Arm/Stirrer

This option is used for checking the alignment of the ARM Probe or Stirrer Assembly. Upon
selecting the Arm or Stirrer Option, the service personnel can check the alignment of the
respective assembly in trough, in sample tray (outer, middle and inner positions), in reagent tray
(outer positions and inner positions), in cuvette & in dilution cuvette. The operator can check
stirrer motor rotation speed at three different options as shown in picture below:

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Initialize: This will initialize the arm/stirrer assembly as per the available options selected from
the list.

Dummy Run: On clicking this button, user can define the Sample, Diluent and reagent position.
After defining the respective positions, on clicking START button, Dummy run is initiated. On
clicking STOP button, Dummy run can be stopped when required.

Execute: This will move the respective assembly in the selected path. This is used to check the
motion of an arm/stirrer assembly in a particular path. Also for checking the Opto conditions.

DCF: This option is used to set the dilution calibration factor. The dilution factor should be entered
in the range 0.75 to 1.25. This feature is used in case if recovery of any of the dilution run is
improper.

Use the following procedure to set the dilution factor:

a. Manually calculate the Dilution Calibration Factor (DCF) using 5x dilution as shown below:

b. DCF = (Expected mean of 5x) / (Observed mean of 5x).

c. Click on the DCF button and enter the resultant DCF value in DCF text box and click on
SAVE.

d. This will save the value in the system. This factor will be transferred to analyzer and will be
stored in analyzer memory.

e. On every power on, this factor will be transferred to MultiXL.

f. MultiXL will multiply the results of dilution, any dilution for 2x to 150x, by this factor and
then result is declared.

In case of restore backup, it is recommended to restart the analyzer in order


to get correct calibration values including DCF.

Sample Tray

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Initialize: This option is used to initialize the Sample Tray. (Position # 1).

Pulse: A PULSE button is also given for moving the sample tray step by step (one pulse gives
micro-step change between 2 positions).

Rotate to Position: This option is used for rotating the sample tray to “X” position depending on
the position selected by the service personnel. To move to next position Sample Tray needs to be
initialized.

Barcode Scan: This option is used to perform Sample Barcode Scan. All the Barcode(s) Read is
displayed on the screen (No cross check or verification of Duplication done). Display remains until
user performs some other operation. To view the same Barcode(s) again user has to click on the
button with Barcode label (This option is available until user remains on the Service Check
Screen).

ASP Barcode Scanner Beam ON/OFF: This option is used to Turn ON or OFF the ASP
Barcode Scanner Beam. On reading the Barcode the Beam turns OFF automatically.

Reagent Tray

Initialize: This option is used to initialize the Reagent Tray. (Position # 1).

Pulse: A PULSE button is given for moving the reagent tray step by step (between 2 positions).

Rotate to Position: This option is used for used for rotating the reagent tray to “X” position
depending on the position selected by the service personnel. (Positions are labeled as “01-I”, “01-
O” represents position One-Inner, One-Outer respectively).

Barcode Scan: This option is used to perform Reagent Barcode Scan. All the Barcode(s) Read
are displayed on the screen (No cross check or verification of Duplication / Checksum / Number of
Digits / Invalid Reagent Code / Invalid Bottle Type are done). Display remains until user performs
some other operation. To view the same Barcode(s) again user has to click on the button with
Barcode label (This option is available until user remains on the Service Check Screen).

RGT Barcode Scanner Beam ON/OFF: This option is used to Turn ON or OFF the RGT
Barcode Scanner Beam. On reading the Barcode the Beam turns OFF automatically.

RCT Tray

Initialize: This option is used to initialize RCT Tray to initial position. (Cuvette Number 39 in path
of Light Beam).

Pulse: This option is given for moving the reaction tray in micro steps (between 2 cuvettes) to
check for the opto-coupler alignment.

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Rotate To: This option is used for rotating the reaction tray to “X” position.

CRU Unit

This function allows the service personnel to check the CRU Functionality. A CRU RUN CHECK
button.

Initialize: This option initializes the CRU Assembly to home position (UP).

Run Check: This option is given to check the functionality of the aspiration and suction probes of
the CRU in this mode.

DOWN: This option brings CRU Down in Cuvette.

Make sure the RCT Cuvettes are aligned before executing this command.

Following options are available after CRU is Down in Cuvette:

CRU Biohazard Suct’n Pump: This option turns the Bio-Hazard Suction Pump ON or OFF.

CRU Water Dispense Valve: This option turns the Water Dispense Valve ON / OFF.

To try this option, first brings CRU Down in Cuvette and keep Bio-Hazard
Suction Pumps ON to avoid any overflow and keep Overflow Suction Valve
OFF.

CRU Detergent Disp Pump: This option is used to turns ON / OFF the Detergent Dispense
Pump ON or OFF.

To try this option, first brings CRU Down in Cuvette and keep Bio-Hazard
Suction Pumps ON to avoid any overflow and keep Overflow Suction Valve
OFF.

CRU Overflow Suct'n Valve: This option turns Overflow Suction Valve ON or OFF.

To try this option, CRU Water Dispense and Detergent Dispense should be
OFF.

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Syringe

Initialize: This option initializes the SYRINGE Assembly to home position.

Aspirate: The service personnel can check the ASPIRATE steps by entering the desired volume
in the field provided. The maximum volume that can be entered for ASPIRATION movement is 375
µl.

Dispense: The service personnel can check the DISPENSE steps by entering the desired volume
in the field provided. The maximum volume that can be entered for DISPENSE movement is 375
µl.

Valve and Pump

This option is used for checking the Valve operations for ARM Trough, ARM PROBE and Stirrer
Trough.

ARM Trough Valve: Turns ON or OFF the ARM Trough Valve.

ARM Probe Clean Valve: Turns ON or OFF the ARM Probe Clean Valve.

STIRRER Trough Valve: Turns ON or OFF the Trough Valve of Stirrer.

RCT/RGT TEMP: This option is used for displaying the RCT & RGT temperature. The RCT
Temperature should be within 37 +/-0.2 °C & the RGT temperature within 8-12 °C.

READ: This button starts reading operation and given Temperature Display till Stopped.

STOP: STOP button should be clicked before moving out of next screen.

Sensor Status: Status of all three temperature sensors are indicated as follows:

P - Present and within limits (36.8 ~ 37.2 °C)

O - Out of Range (Less than 36.8 °C or Greater than 37.2 °C).

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A - Absent (This error will occur when there is no communication between the sensors and Micro
blaze)

L - Loose (This error will occur if sensors are not properly grounded.)

Communication

This option is used for checking the communication between PC and the analyzer. The service
personnel select the COM port and then click on the Check button.

Calibration

This section of Service Check Form is used to Calibrate ARM centering at various applicable
positions. Pre-requisites for this operation is to bring the ARM or STIRRER to required position
using the ARM/STIRRER Move options.

Clock Wise: Set direction of rotation for ARM / STIRRER as Clockwise.

Anti-Clock Wise: Set direction of rotation for ARM / STIRRER as Anticlockwise.

+++ : This button allows Course step movement of ARM / STIRRER.

+ : This button allows FINE step movement of ARM / STIRRER.

Accept: Saves the Course / FINE adjusted value of ARM / STIRRER in to local memory. Values
are not saved in Analyzer until “Save Calib.” Button is clicked.

Cancel: Cancels the locally Accepted Value(s) of Course / FINE adjustment(s) of ARM /
STIRRER.

Default: Cancels and reloads the default position of ARM / STIRRER at respective position of
calibration.

Save Calib: This option is mandatory after calibrating the ARM / STIRRER. The locally Accepted
values are Saved in the Analyzer Non-volatile memory and are used by Analyzer henceforth.

Calibration Menu

The following options are displayed when this button is clicked:

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Read Default Calibration: This option will transfer the new default data (if any) from the ESW
(CPU) to PC.

Read Current Calibration: This option will transfer the current data from the analyzer (i.e.
EEPROM of CPU) to PC.

Load Default Calibration: This option is to load the default values from the PC to analyzer (i.e.
EEPROM of CPU).

Show Current Calibration: This option will displays the current calibration values in the
analyzer.

Before doing calibration Read Default and Current Calibration Values, as


these values are required to check limits of calibration steps at respective
position of ARM / STIRRER.

Current Calib Backup: This option will take the backup of current calibration which is saved in
the EEPROM to PC.

Restore Current Calib Backup: This option will load the backup file onto the EEPROM of the
CPU.

Misc Commands

This option helps to view the current MultiXL and Embedded Software(ESW) versions and also in
uploading the latest ESW version through the MultiXL.

On clicking the Misc Commands button two options appear as shown below;

On selecting Software Version the current Version Numbers for MultiXL Software and Embedded
Software Versions (Analyzer, Micro Blaze, FPGA, PDC and RCT Heater ,barcode and tag) are
displayed.

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On selecting Upload ESW, the latest ESW version can be uploaded from the MultiXL itself. The
following screen is displayed on clicking this option;

The operator selects the path for the .mcs file through the Browse... option and clicks on Start
button. The process of uploading ESW is divided in two parts;
1. Erasing existing firmware from analyzer.
2. Uploading new firmware to analyzer.

If any of the below mentioned error occurs during this process, then user needs to start uploading
process again by clicking on Start Button.

List of Errors Error Codes


Erase not performed E1
File Format Error E2
File Checksum Error E3
Communication Error E4

Once the Embedded Software is uploaded successfully, a prompt for Restarting the analyzer
appears on the screen ;

On restarting the analyzer, this screen shows the updated Embedded Software Versions of the
analyzer.

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Emergency Stop

This button will stop the current service related functionality and initialize the instrument. This
initialization ensures that all the assemblies are at their Home positions so as to begin the next
command.

6.3.9 Master
Master menu is used to enter the master details such as area, doctor, analyst, laboratory,
manufacturer, reference range, unit, calculation formula and instrument.

Master consists of following screens. See for more details:

Consumables

Area

Doctor

Analyst

Laboratory

Mfg

Reference Range

Unit

Unit Conversion

Calculation Formula

Instrument

6.3.9.1 Consumables
Consumables screen is used to define various consumables such as Reagents, Blank, Calibrators,
Controls, Diluent and Wash, including their name along with their respective lot numbers,
reconstituted dates, concentration and on-board stability of the test are defined in the same screen.

Also, it is used to upload and download consumables. See section Upload and Download for more
details.

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See the following procedure to define consumables in more details:

Defining Reagents

User is allowed to define or add only permitted number of open channel


reagents (user defined), after that system will prompt a message.

1. In the Consumable screen, select the Consumable Type to Reagents.

2. Now click on the button next to the Consumable box.

On clicking, the following screen will be displayed.

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3. Enter the appropriate Reagent name, Reagent Code, and Reagent Type.

Reagent Enter the name of the reagent.


Reagent Code Enter the unique Test Code.
This is the 4th and 5th digit on the Reagent Barcode Label on the
bottle. It is used to identify the Reagent and update reagent position
after Reagent Barcode scan.

For closed channel reagents, reagent code should be a unique 2-digit


number in permitted range.

For open channel reagents, reagent code should be a unique 3-digit


number in permitted range.
Reagent Type Select whether the reagent is single reagent or dual reagent. The
available options are:
R1
R1, R2

User is allowed to define or add reagent code only in the permitted range,
otherwise system will prompt a message.

4. Click SAVE to save the details.

On saving the details, the reagent will be added in the list of reagents as shown in the
following figure.

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6. Double click on the Reagent name from the list of reagents. The selected reagent will be
displayed. See the following figure:

7. Click on the ADD button.

The following screen will be displayed.

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8. Now enter the manufacturer name from the manufacturer drop-down list. See section
Manufacturer for adding manufacturer name in the list.

9. Enter the lot number in the Lot No text box.

10.Enter the expiry date of the reagent in the Expiry Date list.

11.Enter the on-board stability and unit in Onboard Stability text-box and Unit drop down list.

12.Select the Reagent Type check-boxes to be used, as required. The Reagent Type
check-boxes will be pre-selected, if it is already defined while entering the details for new
reagent.

13.Once the above details are entered, click on SAVE to save these details.

The reagent will be added and displayed on the grid.

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To modify details for a reagent

Use the following procedure to edit the details for a reagent:


1. To edit the reagent details, go to Consumable screen, select the Consumable Type as

Reagents and click on the button.

On clicking the following screen will be displayed.

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2. Now select the required reagent from the list.

3. Click EDIT.

On clicking, the following screen will be displayed for editing.

4. After editing the details and click SAVE. The details will be saved.

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Lot details can be edited directly by double-clicking on the required lot


from the main Consumable Screen.

Following table gives a brief explanation on the different fields in the grid.

Parameters Description

Manufacturer Select the Reagent Manufacturer from the drop-down list.


A Manufacturer from Master > Mfg screen.

Stock Over Check this Stock Over box when the stock of the consumable lot is
completely utilized.
Lots marked as Stock Over will not appear in the Lot Selection List -
While defining Reagent Positions in the Utility > Reagent
Position screen
While scheduling Calibration and Controls from QC/
Calibration > Schedule QC / Calibration screen.
Note: In case, Stock Over is not ticked for a Lot; then the Lot will be
excluded from the selection list after its expiry date.
This check-box is available only in Edit mode and not while adding a
Lot.

Lot No Enter the lot number of the reagent.

Lot Status Lot status as Active or Inactive is displayed based on the Expiry Date
defined for the Lot. Expired Lot is displayed as Inactive.

Expiry Date Select the expiry date of the Reagent lot.

On-board Stability Enter the On-board shelf life of the reagent.

Unit Select the On-board Stability unit, as appropriate.


Options available are Hours and Days.

Reagent Type Select whether R1 and/or R2 is received for the selected Lot number.
In case, lot numbers are different for R1 and R2, then define both the
Lots for R1 and R2 appropriately.

Following are the description of buttons available on the screen.

PRINT This button is used to print the list of reagents.


SAVE This button is used to save the reagent details.
EDIT This button is used to edit the details of the selected reagent.
CLEAR This button is used to cancel add / edit mode.
DELETE This button is used to delete the reagent

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Default loaded Erba reagents can not be deleted.

Defining Blank

1. In the Consumables screen, select Consumable Type as Blank.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Blank text box and select the tests associated with the blank, and then
click on SAVE.

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Once saved, the user can double click on the blank name for which he wants to add lot
details. This will close the window "Consumable" and take to "Consumable" main screen.
One can also leave the screen by clicking on "X" when one do not want to add lot and go
back to Consumable screen.

4. Click ADD from the main screen, the following screen will be displayed.

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Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No and concentration for the selected blank.

The permissible concentration range for the selected Blank is between 0 to


99999.990

7. After entering the details, click SAVE.

8. On clicking, the blank will be saved and displayed on the Consumable screen, when the
Blank is selected.

Defining Standard

1. In the Consumables screen, select Consumable Type as Standard.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Standard text box and select the tests associated with the standard,
and then click on SAVE.

Once saved, the user can double click on the standard name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one do not want to add lot and go back to
"Consumable" main screen

4. Click ADD from the main screen, the following screen will be displayed.

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5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the concentration for the selected standard.

The permissible concentration range to define a Standard is between 0.001


to 99999.990

9. After entering the details, click on SAVE button.

10.On clicking, the blank will be saved and displayed on the Consumable screen, when the
Standard is selected.

Defining Calibrators

1. In the Consumables screen, select Consumable Type as Calibrator.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Calibrator text box and select the tests associated with that calibrator,
and then click on SAVE.

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Once saved, the user can double click on the calibrator name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one does not want to add lot and go back to
"Consumable" main screen.

4. Click ADD from the main screen, the following screen will be displayed.

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Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the concentration for the selected calibrators.

The permissible concentration range to define a Calibrator is between 0.001


to 99999.990

9. After entering the details, click on SAVE button.

10.On clicking, the calibrator will be saved and displayed on the Consumable screen, when
Calibrator is selected.

Defining Controls

1. In the Consumables screen, select Consumable Type as Control.

2. Click on the dotted button next to Consumable name. This will open a new window
"Consumable".

3. Enter new name in the Control text box, Select the control type from Type drop down list and
select the Level from the available options (Low, Normal, High, and Very High).

4. Select the tests associated with the control, and then click on SAVE.

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Once saved, the user can double click on the control name for which he wants to add lot
details. This will close the window "Consumable" and take to Consumable screen. One can
also leave the screen by clicking on "X" when one do not want to add lot and go back to
"Consumable" main screen

4. Click ADD from the main screen, the following screen will be displayed.

Each test name is displayed along with unit in brackets.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter appropriate Lot No.

7. Select the appropriate Expiry Date.

8. Enter the mean value for the selected tests in the Mean column.

CV will be automatically calculated, if the Mean and SD are entered for the test. Similarly,
SD will be calculated if Mean and CV are entered.
For example: To calculate CV, select option SD and enter the mean and standard deviation
value for the test in the Mean and SD column. On saving the control, the CV will be
calculated and displayed in the CV column.

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Lab Mean column is not user editable. Manufacturer’s mean will be


automatically stored as lab mean, till the lab mean is calculated by the user.

9. After entering the details, click on SAVE button.

On clicking, the control will be saved and displayed on the Consumable screen, when
Control is selected.

Defining Diluent

1. In the Consumable screen, select the required diluent from the Consumable Type.

2. Click on dotted button and enter the diluent name in Diluent text box in Consumable window.

3. Click SAVE.
Once saved, double click on the diluent name for which he wants to add lot number. This will
close the window "Consumable" and take to Consumable screen.

4. Click ADD button.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter the lot number, and then click SAVE.

Two separate positions are provided on the instrument for placing the
diluents. Also, diluents and wash can be placed on any position of the
Reagent Tray.

Defining Wash

1. In the Consumable screen, select the required wash from the Consumable Type.

2. Click on dotted button and enter the wash name in Diluent text box in Consumable window.

3. Click SAVE.
Once saved, double click on the wash name for which he wants to add lot number. This will
close the window "Consumable" and take to Consumable screen.

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4. Click ADD button.

5. Select the Manufacturer name. See section Add Manufacturer for more details.

6. Enter the lot number, and then click SAVE.

6.3.9.2 Area
Area screen is used to enter the area (Location) from which the samples are collected. This list of
area is available in Patient Entry screen and hence for each patient a particular area can be selected.
This selected area (location) is printed in patient reports. See section Patient Reports.

See also:

Add area details

6.3.9.3 Doctor
Doctor screen is used to enter the name and demographics of referring doctor. This list of doctor is
available in Patient Entry screen and hence for each patient a particular doctor can be selected.

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See also:

Add doctor details

6.3.9.4 Analyst
Analyst screen is used to enter the name and demographics of analyst. This list of analyst is
available in Patient Entry screen and hence for each patient a particular analyst can be selected.

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See also:

Add analyst details

6.3.9.5 Laboratory
Laboratory screen is used to enter new or edit the existing laboratory name with their details. These
details will be printed as a header in the patient reports.

There is always a default row with laboratory name as My Laboratory marked with ** sign. This row
cannot be deleted but it can be edited. The name and address of this row is printed as header in the
patient reports.

This list of laboratory is available in Utility > Offline Results screen and hence for each patient a
particular laboratory can be selected.

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See also:

Add laboratory details

6.3.9.6 Mfg
Mfg screen is used to enter new or edit the existing manufacturer name. This list of manufacturer is
available in Consumables screen and hence for each consumable a particular manufacturer can be
selected.

There is always a default manufacturer present marked with ** sign. This row can’t be deleted but it
can be edited that is the name can be changed.

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See also:

Add manufacturer details

6.3.9.7 Reference Range


Reference range screen is used to enter the min and max years/months/days for a reference range.
This list of reference range is available in test Reference Ranges screen and hence for each test a
particular reference range can be selected and the min / max values can be entered.

There is always a default row present marked with ** sign. This row can’t be deleted, it can only be
selected.

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See also:

Add reference range details

6.3.9.8 Unit
Unit screen is used to enter the unit. This list of units will be displayed in Test Details and Calculated
Item screen and hence for each test a particular unit can be selected.

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See also:

Add unit details

6.3.9.9 Unit Conversion


Unit conversion option is used to convert the unit of defined (default) test with appropriate factor.

1. Select the Unit conversion > from Master > there are radio buttons >Test and Calculated Item
and Check box for General > select TEST tab.

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2. Select the test from the drop down list. From unit is mandatory and non editable, To unit > Select
the unit from the drop down list, Enter the appropriate factor for conversion.
3. Select Save > Test grid displays the test for which unit to be converted.

4. To convert unit for Calculated Item > Select the Calculated Item > from drop down list select the
the calculated item, From unit is mandatory and non editable, To unit > to convert the unit from

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the drop down list, Enter the appropriate factor to conversion.

.
5. Select Save > Calculated Item grid displays the test for which unit to be converted.

6. Tick the check box General for unit applicable to all tests and calculated items.

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7. Select From Unit from drop down list > Select To Unit from drop down list
8. Click Save> General grid displays the unit to be converted which is applicable to all tests and
calculated items.

9. Preloaded unit conversions are displayed in their respective grids.

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Unit Conversion can be also uploaded from CD via Parameter Management.

6.3.9.10 Calculation Formula


Calculation Formula screen is used to enter calculation formula. This list of calculation formula is
available in Calculation Item screen and hence for each calculation item a particular calculation
formula can be selected.

Commonly (or frequently) used calculation formula are provided as default list. New formula can be
added to list, as required.

See also:

Add calculation formula details

6.3.9.11 Instrument
Instrument screen is used to enter instrument details. This list of instrument will be displayed in
Offline Results screen and hence for each offline result a particular instrument can be selected on
which result was measured.

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See also:

Add instrument details

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6.3.10 Settings

Settings menu allows you to perform the following operations:

System Parameters

Carryover Pairs

Test Sequence

Re-run Flags

User Rights

Reflex Test

Host Settings

Calibration Policy

6.3.10.1 System Parameters


Settings menu allows you to configure the behavior of the analyzer's hardware and application
software. These settings can be modified using EDIT button at the bottom of the screen.

Item Description

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Laboratory Name It displays the default laboratory name which will appear as header in the
printed patient reports. The default laboratory name can be changed
through Master > Laboratory screen.
Refer section Laboratory for more details.

Default Language The default language for the software screen can be set using this button.
Refer section Setting UI Language for more details.

On Screen Keyboard This check box is used to active on screen keyboard.


User should be ensure to ON tablet mode

Clear Screen upon This drop-down list is used for selecting the clearing of the input screens
Save such as Patient Entry, upon Save operation. The available options are
Yes, No, and User Confirmation.
On selecting option Yes, the screen will be cleared upon Save.
On selecting option No, the screen will not be cleared upon Save and will
display the saved data. Click on CLEAR button in the respective screen
to add new data.
On selecting option User Confirmation; every time upon Save, user will be
prompted to choose the option to clear the screen.

Confirmation Message This check-box is used to select the availability of confirmation message.
Default is checked. If it is checked, on performing any critical operation
such as SAVE or DELETE, a confirmation message will be displayed.

Auto Copy Calibration Tick this check-box to automatically copy the calibration across test(s)
with same assay type and specific curve type (either both linear or both
non-linear requiring the same number of calibrators); sharing the same
Reagents.
This option will be useful for the test(s) created using COPY TEST option
in Test Parameter screen.

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Patient Report This option allows the user to print the Patient Reports automatically
during the batch run, as soon as all the results of a sample are available.
Patient Report can be printed with or without the header.
The following options are available for selection:
OFF
Normal with Header
Normal without Header
Multicolumn with Header
Multi column without Header
Profile with Header
Profile without Header
Graphical with Header
Graphical without Header
Select OFF, in case automatic Patient Report printing is not required.
Patient Report can be printed in any of the 4 different formats, with or
without the header.
Make sure to select the desired Report Options from the Reports >
Patient Reports screen. This will determine whether or not to print
Location (area), Analyst, Sample Remarks and Patient Remarks on the
Patient Report.
IMPORTANT: Set Printer ON, when Online Report or Patient Report
is selected to print.

Online Report Tick this check-box to print the results (list in columnar format) during
batch run.
The following columns will be displayed: Sample position number,
Sample ID, Test, Result, Unit and Flag.
IMPORTANT: Set Printer ON, when Online Report or Patient Report
is selected to print.

Print Negative Result Tick this check-box to print the negative results as it is. On un-ticking
this check-box, the negative results will be printed as 0 (zero) in Patient
Report, instead of negative value.
However, irrespective of the option selected; the screen will always
display the results as it is (negative) and the Online (results) Report will
also print negative values.

Footer Enter the foot note to be printed in the Patient Report (at the bottom).
See Patient Reports.

Signature Two text boxes are available to add the signature on the printed patient
report. It will be displayed in the footer (or bottom) of the printed patient
reports.

Top Margin(inch) and Set the top and bottom margin, in inch, for the printed patient report. The
Bottom Margin(inch) extra space will be added to the top and bottom of the printed patient
reports, as per margin selected.

Analyzer Port Select the COM Port of the PC, at which the Analyzer is connected.
Default port is COM 1.

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Host Connection Tick this check-box to activate the data transmission (patient
demographics, work list and test results) with LIS. Default is checked.
Un-checking this option will close the LIS connection from the analyzer
PC.
When Host connection is activated, configure other parameters from the
Host Settings screen.

Open Channel Test This drop-down list is used to select setting for test parameters. Three
options are available Open, Semi-Closed and Closed.
If Open option is selected, all the inputs on the test parameter
screen are editable and also new tests can be added.
If Semi-Closed option is selected, only some of the inputs on
the test parameter screen are editable for the pre-defined tests.
A new test can be added.
If Closed option is selected, the inputs on the test parameter
screen are non-editable. A new test cannot be added.
This option may be used to secure the Test Parameter screen.
This option will be disabled in closed system.

RCT Temperature It displays the RCT Temperature in C. The default value is 37 C.

RCT Temperature It is used to set the allowable fluctuation in RCT Temperature. Enter the
Range range between 0 and 0.5.
During batch run, when the RCT temperature fluctuation is outside the
specified range, warning message “Temperature out of Range” is
displayed on Status Monitor, logged in Error Log. All the results (except
ISE) in process will be declared with @TMP flag.

RGT Temperature This field displays the RGT Temperature in C. This value is 8 C.

RGT Temperature This field is used to set the allowable fluctuation in RGT Temperature.
Range Default value is 4 C. User can enter the range between 0 and 4.

Sample Barcode This option is used to select the availability of Sample Barcode. Default is
ticked (available).
When the sample barcode identification is not desired, un-tick this option
& SAVE. In such case, in Patient Entry screen, the Barcoded option
Sample Definition Parameters and Sample Barcode Scan in Status
Monitor > Barcode Scan will be disabled and entry of sample position
number is mandatory.

Reagent Barcode This option is used to select the availability of Reagent Barcode. Default
is ticked (available).
When this option is un-ticked, Reagent Barcode Scan option in Status
Monitor > Barcode Scan is not available. Reagents should be defined
manually from Utility > Reagent Position screen.

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Hibernate After This option is visible only if sleep mode hardware is installed on the
analyzer.
This text box is used to enter time in minutes for the analyzer to
hibernate (or sleep). The default hibernate time is 15 minutes. The
analyzer automatically hibernates if the analyzer is kept inactive or
standby for the specified time in minutes. User can specify the time to
hibernate between 10 minutes to 60 minutes.
User can manually hibernate the analyzer, if required, by using
Hibernate option in the main menu layout. See section 7.9 Hibernate/
Wak e-Up for more details.
When an analyzer goes into hibernation, it shuts down the Halogen
Lamp, Vacuum pump and DI Water Pump.

The analyzer will automatically hibernate if user activity is not


performed after the following operations:
After Completion or termination of batch run, when Analyzer is
standby for specified time.
If the analyzer is standby for 1 hour while in the Maintenance
screen.
After performing the Auto Maintenance activity on start of the
day, when Analyzer is standby for specified time.
NOTE:
Analyzer will never hibernate if the Service Check screen
is open.
Analyzer will take 70 seconds approximately to wakeup
from the sleep mode (hibernate).

ISE Module This option is used to select the availability of ISE.


When un-ticked, ISE options are not available for scheduling & for batch
run.

Machine SR. NO. Enter the serial number of machine (analyzer).

Action On ISE Calib Set any one of the action, as appropriate.


Failed (If installed) The selected action will be performed if the ISE calibration on start of the
batch run fails.
Stop Run
Batch run stops. User can take corrective action and calibrate ISE
manually.
Proceed With the Calibration in range
When this option is selected, batch run starts. Results of only
those ISE test(s) will be declared for which calibration is reported
within range.
Skip ISE Test and Proceed
Batch run starts with only photometric test(s), skipping ISE
schedules.

Minimum Cell Blank Enter the Minimum Cell Blank Absorbance from 0.01 to 0.05. If the
absorbance of the cell blank falls below this limit, then the colour of the
cuvette Absorbance value in the Maintenance > Cell Blank screen will
change to Blue. Default value is 0.03.

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Maximum Cell Blank Enter the Maximum Cell Blank Absorbance from 0.1 to 0.2. If the
absorbance of the cell blank falls above this limit, then the colour of the
cuvette Absorbance value in the Maintenance > Cell Blank screen will
change to Red. Default value is 0.2.

Extrapolation Specify the desired percentage to extrapolate the calibration graph to a


particular percentage. Value between 0 to 20% can be entered. If the
value is 0, the graph is not extrapolated.

Container Type Set the default container type from the list.
The selected option will appear as the default container type while adding
samples in the Patient Entry screen.

Clot Detection Tick this option to activate Clot Detection feature for samples.

Threshold Level for Low Set the required threshold level percentage with respect to the Bottle
Volume in RGT Bottles Capacity, for low reagent volume indicator for the following reagent bottle
types :
Large
Small
Tube
By default, 20% for large bottles (50 ml), 10% for small (20 ml), and 25%
for small tube is defined.
Specified percentage is used to indicate Reagent Volume Low, with
yellow color, on Reagent Tray screen of Status Monitor.

Min QC Result for Lab Set the minimum QC points required for lab mean.
Mean Enter value between 1 to 999. Default value will be 20.

6.3.10.2 Carryover Pairs


Analyzer typically uses probe to dispense reagents, and this probes are exposed in rapid
succession to a wide spectrum of different reagents. A very real concern with analyzers is reagent
carryover, that is, reagent from an initial assay clinging to a reagent probe and contaminating the
reaction mixture of the next test immediately following the initial assay.

Using this screen, you can define the forbidden pair for a particular chemistry.

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In order to maintain consistency and accuracy of the results an additional wash


cycle before/after a particular test can be defined.

Steps for Additional Wash before a particular Test:


Click on SETTINGS and select CARRY OVER PAIRS.
In *Contaminant (1st) Test drop-down menu select**Any Test**
In *Contaminated (2nd) Test drop-down menu select ‘Test’ (select test which requires additional
wash)
Select appropriate wash type / volume / cycles.
Click on SAVE.

Steps for Additional Wash after a particular Test:


Click on SETTINGS and select CARRY OVER PAIRS.
In *Contaminant (1st) Test drop-down menu select ‘Test’(select test which requires additional
wash).
In *Contaminated (2nd) Test drop-down menu select **Any Test**
Select appropriate wash type / volume / cycles.
Click on SAVE.

Parameters Description
Contaminant Select the first contaminant chemistry.
(1st)Test
Contaminated Select the second chemistry that could get contaminated.
(2nd) Test
Skip Cuvette This option is used to skip the cuvette. Whenever a contaminated test comes
under a cuvette where the contaminant test has been performed (consecutive
use), the cuvette will be skipped automatically.

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Wash The user can select the wash whether for that pair, a Reagent 1 or Reagent 2 or a
Detergent Wash or both Reagent 1 and Reagent 2 are required.
Select the following options, as appropriate:

No Wash

Reagent 1 Wash

Reagent 2 Wash

Reagent 1 and Reagent 2 Wash

Detergent Wash

Wash Cycles It displays the number of times the Wash cycle is performed. The default value is
1.
R1/R2 Volume If reagent Wash is selected, then the user can define the R1 and R2 volume to be
aspirated from the contaminated test for cleaning the probe.
System Wash Select this option for a pair of tests. In System Wash, the Arm will be washed
internally and externally with internal DI water at trough, after picking up
contaminant test.

When this option is selected, the Wash drop down list will be disabled.

For Detergent Wash, prepare Wash Solution (preferably phosphate-free neutral


1% Extran or 0.025% Hypochlorous Acid). Also, the same pair cannot be
programmed for 2 different type of wash.

In Carryover Pair screen, DELETE button will be disabled for default loaded
carryover pairs.

6.3.10.3 Test Sequence


Test Sequence is used to define the sequence of tests to display on screen and print in patient
report.

Processing the sequence of the test(s) can also be set from this screen.

Tests can be arranged in sequence using the following four available options:

Test display sequence

Test process sequence

Print sequence for patient reports

Profile sequence for patient reports

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6.3.10.3.1 Test Display Sequence

This option is used to set the sequence of tests. Once the test display sequence is set, the test(s)
will appear in the specified sequence in the following screens:

Patient Entry

Reports

Search

Test Parameter > Test Details

Test Parameter > Test Volumes

Test Parameter > Reference Ranges

Profiles/Calc > Profiles

QC Calibration > Calibration

The sequence of test can be displayed in alphabetical order (ascending and descending). Use
difference modes to set the order as per requirement.

It also provides a drag-and-drop mechanism to let you directly rearrange the test in a sequence within
the grid.

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6.3.10.3.2 Test Process Sequence

This option is used to set the process sequence of photometric tests, before or during the run.

It is useful in avoiding contamination by forbidden pairs that may come together during the run.

Dynamic Process Sequence

To eliminate carry over between the last test executed and next test to be executed, we can select
USE DYNAMIC PROCESS SEQUENCE.

In this, the tests are rearranged in a sequence that the carry over washes are reduced to the extent
possible maintaining higher throughput.

To set the test process sequence to dynamic process sequence, select option TEST PROCESS
SEQUENCE, tick on the adjoining check box USE DYNAMIC PROCESS SEQUENCE and then click
SAVE.

Two options will be visible on selecting the TEST PROCESS SEQUENCE option.

Closed Channel First and then Open Channel

Open Channel First and then Closed Channel

The closed channels tests and open channels tests are displayed in separate
sections.

On selecting any of the option, tests assigned for each sample will be processed

XL-200
User Interface 6-200

according to the test sequence as defined in the Closed Channels Tests grid and
Open Channel Tests grid. See the following figure for more details.

Sequence of closed channel tests can not be changed. Sequence of open


channel tests can be changed, if defined.
Refer section Test Parameter screen for more details.

Copied test with Closed reagent in Test Parameter is non editable in the list of Test Process
Sequence of closed channel test.

Copied test with Open reagent in Test Parameter is editable in the list of Test Process Sequence
of open channel test.

For Particular Test if Open/Closed reagent is changed from Test Parameter >Test Details, then this
test will be displayed in Test Process Sequence list in respective section of open / closed channel
test based on the changed reagent type.

6.3.10.3.3 Print Sequence For Patient Reports

This option is used to set the sequence of test and calculated items to be printed on the patient
reports.

XL-200
6-201 User Interface

6.3.10.3.4 Profile Sequence For Patient Reports

This option is used to set the sequence of profile to be printed on the patient reports in Profile format.

XL-200
User Interface 6-202

6.3.10.4 Re-run Flags


Rerun Flag screen is used to select the rerun flags for which auto-rerun of the test is required during
batch run.

If a particular flag is de-selected, then auto-rerun will not be performed when the flag is issued along
with the result for that test, even though auto-rerun is selected for the test from Test Parameter
screen.

6.3.10.5 User Rights


User Rights screen allows administrator to perform following operations:

Create and delete user ID and password

Provide access rights to new and existing users

See section Access control for more details.

User is the default user name with all user rights. See the following figure.

XL-200
6-203 User Interface

6.3.10.6 Reflex Test


Reflex test option is used to reflex the particular test based on result flag of first test.
1. Select Setting > Reflex Test > tick the Reflex On box

2. Select the Test from the drop down list.


3. Select the Reflexing To test from the drop down list.

XL-200
User Interface 6-204

4. Tick Reflex On text box


5. Select the reflexing flag.and save the details

6. When selected flag gets attached to scheduled test, then reflex test will get performed.

6.3.10.7 Host Settings


Host Settings screen is used to define the settings required to establish the communication between
the analyzer's PC and Host PC (LIS software).

XL-200
6-205 User Interface

Depending on your network type (Peer-to-peer or LAN), choose the appropriate communication mode
from the screen. They are:

RS 232C

TCP/IP

Select RS 232C, if the analyzer and PC is connected in peer-to-peer (through serial port).

Select TCP/IP, if the analyzer and PC is connected in LAN (Local Area Network).

See section Connection to Host PC for more details.

See the options available on screen:

Send Patient Results to Host

Send Control Results to Host

Send Limit Values for flagged Results

Schedule Test Again

Send Sample Position

The additional buttons available on this screen are as follows:

CHECK CONNECTION: This button is used to check the communication between Host and analyzer
PC.

XL-200
User Interface 6-206

SAVE: This button is used to save the settings.

CLEAR: This button is used to clear the changes.

EDIT: This button is used to edit the changes.

CLEAR RESULT QUEUE: On clicking this, button, the ongoing result data to LIS will be stopped.

HELP: This button displays the ASTM HOST help file in more details.

This screen is editable only, if Host Connection option is ticked.

6.3.10.7.1 Send Patient Results to Host

When this option is selected, the patient results, which are generated during the batch run will be
automatically sent to LIS.

After selecting the option, click SAVE to save the settings.

For any test containing "µ" in unit, "µ" gets transmitted as "u" to LIS.

6.3.10.7.2 Send Control Results to Host

When this option is selected, the control results, which are generated during the batch run will be
automatically sent to LIS.

After selecting the option, click SAVE to save the settings.

6.3.10.7.3 Schedule Test Again

When this option is selected, system will accept redo test action received from LIS and re-do the
tests for that sample.

6.3.10.7.4 Send Sample Position

When this option is selected, patient results sent to LIS will be displayed with associated sample
position number and disk number.

6.3.10.7.5 Query Sample at a time

After Sample Barcode Scan, MultiXL application will request LIS for downloading test details for the
samples scanned during run or Sample Barcode Scan. MultiXL will query either 1 sample or 5
samples at a time. Select appropriate option from the following, in consultation with LIS vendor.

Single

Multiple(Max 5 Samples)

6.3.10.7.6 Checksum

This option allows user to enter character encoding set for all checksum calculations.

In order to support data transmission in Russian and any Cyrillic language the checksum calculation
needs to be in UTF-8 encoding.

XL-200
6-207 User Interface

It is purely a user-preferred option w hich is set to the default mode by the


system application.

6.3.10.7.7 Send Limit Values for flagged Results

Select this option to send limit values to LIS for flagged patients’ results instead of sending ‘NA’. It is
only applicable for flags TEC-H, TEC-L, RANGH, RANGL, AbsLIM, LINXX and P* (prozone limit).

After selecting the option, click SAVE to save the settings.

6.3.10.8 Calibration Policy


Calibration Policy option is used to calibrate reagent system pack lot and bottle before using the
reagent for measurement in the batch run.

1. Select Setting > Calibration Policy

2. There are following sections are available :

Calibration Policy for Closed Channel Tests

Calibration Setting -Closed Channel Reagents

When reagent bottle is calibrated within 24 hours of 1st barcode scan then this is
called as Lot calibration.
If this calibration is performed after 24 hours from the 1st barcode scan of the
reagent bottle, is called as Bottle Calibration.

XL-200
User Interface 6-208

For Lab-Administrator user following access can be given:


-Modify Calibration Policy Settings AND/OR
-In Calibration screen, choose previous Calibration Curve using Set Latest
Calibration.

6.3.10.8.1 Calibration Policy for Closed Channel Tests

This section displays the following option;

When Lot / Bottle Calibration is not available

1. Click Edit > select the option

Use Latest Calibration and To select the latest available calibration of lot / bottle for
Continue RUN measurement

Mask respective Tests and To mask the respective tests and continue the Run.
Continue Run When this option is selected, system will show the message for the
test for which calibration is required Go to Monitor > Work List
Do not Start Run Run will not start without calibration and sampling will be paused

XL-200
6-209 User Interface

2. When check box "Issue Cal** flag when appropriate Lot/Bottle Calibration is not available" is
ticked > Cal** flag will be issued whenever Lot/Bottle Calibration is not used. When this check box
is Un-ticked > system will not flag results even if Lot/Bottle calibration is not available.

6.3.10.8.2 Calibration Setting -Closed Channel Reagents

This section displays the following options;

1. Select the reagent and Click Edit

2. Mention the following details;

XL-200
User Interface 6-210

Bottle Calibration frequency Enter the frequency in day(s) to recalibrate the same reagent bottle
in day(s) from 1st barcode scan of that bottle on reagent tray. After duration
over, status messages grid displays the info.

On Board Stability in day(s) Enter the on board stability in day(s) to use the same reagent bottle
from 1st barcode scan of that bottle on reagent tray. After duration
over it is not recommended to use same reagent bottle even if fresh
recalibration is done and status messages grid displays the info.

Lot Calibration Frequency in Enter the frequency in day(s) from drop down list to recalibrate lot
day(s) with new reagent bottle of the same lot. After duration over, status
messages grid displays the info.

Discard Remaining Reagent When this option is ticked, then after costuming one reagent (R1 or
R2) from pair reagents (R1+R2) then R1 get discarded along with R2
and vice versa.
When this option is Un-ticked,then after consuming one reagent (R1
or R2) from pair reagents (R1+R2) then only R1 or only R2 get
discarded.
Discard Remaining Reagent Option and Column is disabled when
'Use Latest Calibration and Continue RUN' is selected.
This option is enabled when 'Mask respective Tests and Continue
Run' & 'Do not Start Run' options are selected

3. Click Save to save the details.

For bottle calibration frequency and on board stability , if user scan new reagent
bottle and calibrating the same bottle in mention duration (days), then count
(day(s)) for that bottle will reset to 0.

XL-200
6-211 User Interface

6.3.11 Hibernate/Wake-up
This option is used to manually hibernate or wake-up the analyzer. See the following section for more
details:

Hibernate

Wake-up

This feature is hardware dependent and option is visible only if the sleep mode
hardware is installed in the analyzer..

When the system is in hibernation state, the following activities will wake-up the analyzer
when you click on the following screen:

Service Check

Maintenance

Sample Barcode Scan, Reagent Barcode Scan and Volume Scan in Status Monitor
screen

Shut Down

Before shutting down the analyzer, a confirmation message is displayed “Do you really want
to Wake Up?” If clicked Yes, then it will wakeup.

6.3.11.1 Hibernate
To hibernate, use the following procedure:

1. Click on Hibernate from Main screen.

A message will be displayed.

2. Click Yes.

On clicking, analyzer will go to power saving sleep mode and the option will be displayed as

Wake Up.

XL-200
User Interface 6-212

6.3.11.2 Wake-up
To wake-up the analyzer, use the following procedure:

1. Click on Wake Up from Main screen.

A message will be displayed.

2. Click Yes.

Analyzer will come out from hibernate (power-saving sleep) mode and again the option will be

displayed as Hibernate.

6.3.12 Shut Down


Shut Down is used to close the MultiXL application. Also, there is an option to perform the automatic
maintenance operation before closing the application.

Select Main layout > Click , following screen will be displayed;

See the following screen for more details:

Shut Down

Water Save and Shut Down

Maintenance and Shutdown

Before system shutdown, a progress bar may be displayed on the screen which

XL-200
6-213 User Interface

indicates that the archive operation is in progress.

In this operation, backup of MultiXL database and Log files (XLComLog,


STATUSMSG, ASTMComLog and all xls files) are automatically archived in the
C: drive under MultiXLLog_Backup folder.

It is an automatic operation, which will be performed only after every seven days
when system is shutting down.

6.3.12.1 Shut Down


Use this button to close the MultiXL application. When this button is clicked, the analyzer and PC
will be automatically turned off.

6.3.12.2 Water Save and Shut Down


On clicking this button, the MultiXL software minimizes and the water save operation is performed.

After completing the Water save activates, it will shutdown the MultiXL application, PC, and Analyzer
automatically.

During the water save operation, if the application software is closed, a


warning message is displayed for confirmation to stop the water save
operation and shut down the software.

This option will be disabled when the analyzer is in hibernate mode


(sleep mode).

On clicking this option, the Status Monitor, Service Check, and


Maintenance screen will be disabled.

6.3.12.3 Maintenance and Shut Down


On clicking this button the auto maintenance activity will be performed and the system will shut down
after completing the operation. The MultiXL software is minimized during the auto maintenance
operation. See Service actions during auto maintenance at Shutdown for more details.

Once the auto maintenance operation is completed, MultiXL software and instrument will
automatically turn off.

This option will be disabled when the analyzer is in hibernate mode (sleep
mode).

During Water Save and Shut Down or Maintenance and Shut Down operation,
the Maintenance screen, Service Check screen, and Status Monitor screen will
be disabled.

6.3.13 Master Calibration


Follow steps as below to perform Master Calibration from card:

1. Go to Monitor > Select Scan Pack > System Pack Details screen will get displayed. Refer
Scan Pack for details.
2. Keep the master calibration card in front of Test loader device and press Scan Pack > following
details will get displayed on the screen:

XL-200
User Interface 6-214

3. Click Register to load master calibration from card.


4. After pressing register "Load Master Calibration Process Completed " message window will
get displayed on the screen.

5. For invalid reagent code, calibration can not be loaded for that code and accordingly message will
get pooped up.
6. User can also load master calibration from Utility > Scan pack
7. After registered the master calibration, go to main screen QC/Calibration > Calibration>
8. Select the test form the test panel for which master calibration is loaded form the card.
9. Master calibration for that test will get displayed with the consumable details on the screen as
shown below;

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6-215 User Interface

10.Go to main screen> Patients> Master calibration- test will get displayed in test panel.

11. Go to Report > Calibration Monitor > Master calibration test will get displayed.

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User Interface 6-216

During RUN master calibration from card can not be loaded.

XL-200
Part

VII
Operation 7-2

7 Operation
This section gives you a detailed description of daily workflows and step-by-step information about
common procedures that you need to perform as part of your daily workflow.

The workflow is divided into the following three sections:

Daily start-up

Daily routine

End of day task

Also, this section tells you the basic sequence of operations during the sample analysis. See the
following sections for more details:

Sequence of operations

Measurement operation table

7.1 Sequence of operation


The instrument works on the principle of light photometry combined with the best mechanics for
sampling. The sample under test is sampled into the cuvette, which is then read at defined time
intervals to find out optical densities.

The reaction is read at defined time interval of 18 seconds to obtain their optical densities.

The entire operation can be divided into the following sequence:

1. Getting ready for operation

2. Cuvette rinsing (cleaning)

3. Reagent 1 + Sample addition

4. Stirrer Mixing for R1 + Sample mixture

5. Reading and then reporting

6. Reagent 2 Addition (optional)

7. Stirrer Mixing after R2 addition (optional)

8. Reading and then reporting

9. Removal/empting of bio-hazard reaction waste from the cuvette.

7.2 Measurement operation table


The analyzer records absorbance for a cuvette every 18 seconds over a span of 10 minutes 48
seconds. These readings are used for result calculation. The measurement points are referred to as
M1Start, M1End, M2Start and M2End. Refer section Test Details, point number Assay Points.

Time Cycle Analyzer Action


(Minutes) Number

XL-200
7-3 Operation

0.00 0 Dry the cuvette, Add Reagent 1 + Sample

0.18 1 Stir 1 + Measure reaction mixture absorbance

0.36 2 Measure reaction absorbance

0.54 3 Measure reaction absorbance

1.12 4 Measure reaction absorbance

1.30 5 Measure reaction absorbance

1.48 6 Measure reaction absorbance

2.06 7 Measure reaction absorbance

2.24 8 Measure reaction absorbance

2.42 9 Measure reaction absorbance

3.00 10 Measure reaction absorbance

3.18 11 Measure reaction absorbance

3.36 12 Measure reaction absorbance

3.54 13 Measure reaction absorbance

4.12 14 Measure reaction absorbance

4.30 15 Measure reaction absorbance

4.48 16 Measure reaction absorbance

5.06 17 Add Reagent 2 + Stir 2 + Measure reaction


absorbance

5.24 18 Measure reaction absorbance

5.42 19 Measure reaction absorbance

6.00 20 Measure reaction absorbance

6.18 21 Measure reaction absorbance

6.36 22 Measure reaction absorbance

6.54 23 Measure reaction absorbance

7.12 24 Measure reaction absorbance

7.30 25 Measure reaction absorbance

7.48 26 Measure reaction absorbance

8.06 27 Measure reaction absorbance

8.24 28 Measure reaction absorbance

8.42 29 Measure reaction absorbance

9.00 30 Measure reaction absorbance

XL-200
Operation 7-4

9.18 31 Measure reaction absorbance

9.36 32 Measure reaction absorbance

9.54 33 Measure reaction absorbance

10.12 34 Measure reaction absorbance

10.30 35 Measure reaction absorbance

10.48 36 Measure reaction absorbance + Final result


reporting

11.06 37 Empty cuvette contents + Add detergent

11.24 38 Empty cuvette contents + Add DI Water

11.42 39 Empty cuvette contents + Add DI Water

12.00 40 Empty cuvette contents + Add DI Water

12.18 41 Empty cuvette contents + Add DI Water

12.36 42 Empty cuvette contents + Add DI Water

12.54 43 Measure cuvette blank absorbance

13.12 44 Empty cuvette contents

13.30 45 Drying the cuvette

7.3 Daily start-up


This section tells you the daily start-up procedures which prepare your analyzer for the day.

See the following section for more details:

Verifying system resources

Starting up and logging on to system

Defining required consumables

Defining samples and reagents

7.3.1 Verifying system resources


This section tells you the necessary verification of resources to be performed daily before starting the
instrument for analysis.

System Water Can and Waste Can

Confirm that:

The DI water Can is filled with pure DI water and the pH of the water should be maintained at
7.0.

Bio-hazardous Waste Can should be emptied.

Cleaning Solution Can

XL-200
7-5 Operation

1. The cleaning wash solution should be filled with sufficient wash solution.

Preparation of Cleaning Solution

1. Fill the cleaning solution can (given with the Accessories List) with 20 liter of DI water.

2. Pour the 200 ml concentrated solution into the can to prepare a 1% detergent solution.

3. Mix it well before use.

Preparation of Tank Solution

The external tanks of the system DI water, detergent, bio-hazardous waste and diluted waste are
to be placed near the right-hand side or rear side of the analyzer and to be connected to the
analyzer with the corresponding tubes which includes float sensors.

Just before measurement, the external tanks of the system DI water and cleaning solution are
filled with the corresponding liquid, and the tanks of the bio-hazardous waste and diluted waste
have to be empty.

De-ionized Water

Detergent solution

Bio-hazard (Concentrated) Waste

Diluted Waste

The DI water should have a resistivity of more than 1 Mega Ohm-cm (or conductivity less than
1µS/cm). Also the pH of the DI Water should be maintained to 5.0 to 7.0.

7.3.2 Starting up and logging on to the system


Follow this procedure for starting the analyzer

1. Perform the following verification before starting the equipment.

Make sure that tube connections with Bio-hazardous waste Can, Cleaning Can, DI
Water Can and Waste Can are properly done.

Make sure that tray lids or covers are properly placed on Sample Tray, RCT, and
Reagent Tray.

2. Once the verification is done, turn on the main power supply switch.

Before starting the main supply, make sure that the Main ON/OFF
switch and secondary switch provided on the left and right side of the
analyzer should be in OFF condition.

3. Turn on the primary switch that is provided on the back side of the analyzer.

When this button is on, the ISE unit will be started (if installed on the
instrument).

XL-200
Operation 7-6

Verify and confirm that the reagent cooling fan has started rotating,
also touch and physically verify the cooling of the reagent tray, also
verify from the sound, that the ISE pumps have started priming.

4. Turn on the secondary switch provided on the right side of the analyzer. After turning on the
switch, all the assemblies initialize to its home position.

This will initializes the system, and all assemblies will come to home position. Now the
instrument is powered-ON, and ready.

5. Turn on the PC.

The MultiXL software will start automatically and the login screen is displayed.

6. Enter the login details and click OK.

You now have access to the system, depending on your user access level.

If the analyzer is already ON, the system goes through a series of automatic service
maintenance actions. Typically, these actions are performed before the work day begins,
so that the instrument is ready to use when you start work. No user action is required in
this process. See section Auto Maintenance for more details.

The maintenance actions can be performed any time through Maintenance screen.

7. Now the instrument is ready for further run.

The main power switch should be on at all times except in an


emergency. The main power supplies electricity to ISE unit for automatic
priming of ISE (If installed).

7.3.3 Defining required consumables


Before placing the reagents and sample for analysis, define required consumables through
Consumable screen.

See Consumable screen for more details.

7.3.4 Preparing Samples and Reagents


Before starting the analysis, the patient samples and reagents must be dispensed in the containers
and placed in the sample and reagent tray.

Conditions for the Sample Containers

Multiple container sizes can be used in sample tray.

The Dead Volume probe stroke must be set appropriately for the range of
tubes in use.

The operator must ensure that the sample is present in the sample container.
If the dead volume is not set appropriately for all types of containers then
incorrect sampling from that container will happen.

XL-200
7-7 Operation

Use the following containers in sample tray:

10 ml Tube (16 mm x 100 mm)

7 ml Tube (14.5 mm x 84 mm)

5 ml Tube (13 mm x 75 mm)

2 ml Sample Cup

Instruction

Check that there is sufficient serum for analysis in the primary tube, in addition to the dead
volume required for sample detection. The dead volume required for sample detection varies
depending on the sample container type. If the serum height in the sample container is less than
the limit, transfer the serum into a smaller container and then start the analysis. Otherwise, when
the blood cells under the serum in the container are aspirated, analysis and dispense
abnormalities could occur.

Specification of Barcode Label

Item Description

Symbols NW-7, Code39, ITF, UPC, Code128 (Set A, B, C)

Maximum Number of Digits The bar codes must be in conformity with one of the following
bar modules and with bar code printing range.
The maximum allowable number of digits varies depending on
symbols.
NW-7: 6 to 18 digits
Code39: 6 to 18 digits
ITF: 6 to 18 digits
UPC: 6 to 18 digits
Code128 SetA : 6 to 18 digits
Code128 SetB : 6 to 18 digits
Code128 SetC : 6 to 18 digits

Bar module Fine bar: 0.25 to 1.0 mm

Barcode printing
Range

Printing Black on white background (B633) Numeric coding


information is printed beside bar code. Printing on thermal
paper is not allowed in order to prevent bar code from time
varying degradation.

Positioning of barcode label The position is such that there is no obstacle between the
barcode printing area and the bar code reader.

Applying Barcode Labels to the Sample Containers

XL-200
Operation 7-8

1. Place the barcode labels onto the sample containers so that they meet the following
conditions:

2. The lowest bar of the barcode label should be 15 mm (+/- 2 mm) above from the bottom of
the sample container. If the label is applied below this position, the reader may not read the
Sample Barcode.

3. The Highest bar of the barcode label should not be beyond 59 mm (+/- 2 mm) from the
bottom of the sample container. If the label is applied beyond this position, the reader may
not read the Sample Barcode.

4. Make sure that the entire surface adheres to the tube properly.

5. The barcode label should not rise above the top of the tube.

Barcode Placement on Reagent Bottles

Necessary reagents and wash solutions for analysis are placed on the reagent tray.

Applying bar code labels to the reagent bottles:

Place the barcode label on the Flat side of the Reagent bottle so that they meet the following
conditions:

The lowest bar of the barcode label should be 18 mm (+/- 2 mm) above from the bottom of
the reagent bottle. If the label is applied below this position, the reader may not read the

XL-200
7-9 Operation

Barcode.

The Top most Bar of the barcode code label should not be beyond 81 mm (+/- 2 mm) from
the bottom of the reagent bottle. If the label is applied above this position, the reader may
not read the Barcode.

Place the label so that it is parallel with the sides of the bottle.

Make sure that the entire surface adheres to the reagent bottle.

The barcode label should not rise above the top of the bottle.

7.3.5 Defining samples and reagents


Before starting the analysis, the patient samples and respective reagents must be dispensed in the
containers and placed in the trays.

Refer section Preparing Samples and Reagents for more details.

Following sections will show you how to defnin sample and reagents through MultiXL.

Defining Samples

Defining Reagents

7.3.5.1 Defining Samples


Samples can be barcoded or non-barcoded. Follow the appropriate procedure for defining samples.

Refer section:

Barcoded

Non-Barcoded

7.3.5.1.1 Barcoded

Use the following steps to define the barcoded sample:

1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).

2. Go to Patient Entry screen, and enter the following necessary details.

a. Enter the Sample ID.

a. Select the Barcoded option (if sample tube is barcoded).

For emergency samples, select Emergency option, if required.

b. Enter the group number in Group text-box, if required.

c. Enter other details for the patient, as required:

Sample Type
Sample Vol Type
Area
Ref Doctor
Sample Remark
Container Type

XL-200
Operation 7-10

Collection Date
Reg. Date
Sample Replicates
Analyst
Patient Name
Age
Category
Patient ID
Address (of Patient)
Telephone
Patient and Sample Remarks
Select required tests, calculated items and profiles from Tests grid.

3. Click on SAVE.

4. This will save the programmed patient details and presents a new screen for programming
the next patient where the sample ID and sample positions are automatically incremented
if option Barcode is unchecked.

5. Use EDIT button, to edit or modify the already entered details.

6. Open Utility > Reagent Position screen, and define the necessary reagents required for
the test.

7.3.5.1.2 Non-Barcoded

Use the following steps to define the barcoded sample:

1. Place the sample tube or cups on the sample tray (at any position from 1 to 30).

2. Go to Patient Entry screen, and enter the following necessary details.

a. Enter the Sample ID.

b. Un-check the Barcoded option.

c. Enter the sample tube position number in the Position text-box.

For emergency samples, select Emergency option, if required.

a. Enter the group number in Group text-box, if required.

b. Enter other details for the patient, as required:

Sample Type
Sample Vol Type
Area
Ref Doctor
Sample Remark
Container Type
Collection Date
Reg. Date
Sample Replicates
Analyst
Patient Name
Age
Category
Patient ID

XL-200
7-11 Operation

Address (of Patient)


Telephone
Patient and Sample Remarks
Select required tests, calculated items and profiles from Tests grid.

3. Click on SAVE.

4. This will save the programmed patient details and presents a new screen for programming the
next patient where the sample ID and sample positions are automatically incremented if option
Barcode is unchecked.

5. Use EDIT button, to edit or modify the already entered details..

6. Open Utility > Reagent Position screen, and define the necessary reagents required for the
test.

7.3.5.2 Defining Reagents


Before doing the analysis, place the necessary reagent and wash solution on the reagent tray.

Stick the barcode labels on the flat side of the reagent bottles and perform barcode scan operation
through Status Monitor. See section Barcode Scan for more details.

The analyzer will scan the reagent bottles and automatically detects and save the details (like
Reagent position number, lot number, Expiry date etc) related to the reagents placed in the reagent
bottles. Those details are saved and can be viewable on Status Monitor and Reagent Position
screen.

If the reagents are not having the lot details, it can be defined through the Consumable screen.

Condensation can take place on the walls of the reagent tray, near the reagent
bottle neck or on the barcode label due to the reagent cooling mechanism. If
condensation is present, then remove it using a dry tissue/paper.

To Add a new Reagent

User is allowed to define or add only permitted number of open


channel reagents (user defined), after that system will prompt a
message.

1. In the Consumable screen, select the Consumable Type to Reagents.

2. Now click on the button next to the Consumable box.

3. On clicking, the following screen will be displayed.

XL-200
Operation 7-12

4. Enter the Reagent name, Reagent Code, and Reagent Type.

5. Click SAVE to save the details.

6. The following are the description of the parameters on the screen.

Reagent Enter the name of the reagent.


Reagent Code Enter the unique Test Code.
This is the 4th and 5th digit on the Reagent Barcode Label on
the bottle. It is used to identify the Reagent and update reagent
position after Reagent Barcode scan.

For closed channel reagents, reagent code should be a unique


2-digit number in permitted range.

For open channel reagents, reagent code should be a unique


3-digit number in permitted range.
Reagent Type Select whether the reagent is single reagent or dual reagent.
The available options are:
R1
R1, R2

User is allowed to define or add reagent code only in the permitted


range, otherwise system will prompt a message.

7. The following are the description of the buttons on the screen.

XL-200
7-13 Operation

PRINT This button is used to print the list of reagents.


SAVE This button is used to save the reagent details.
EDIT This button is used to edit the details of the selected
reagent.
CLEAR This button is used to cancel add / edit mode.
DELETE This button is used to delete the reagent (till not used
either in batch run or Test Parameters).

Default loaded Erba reagents can not be deleted.

8. On saving the details, the reagent will be added in the list of reagents as shown in the
following figure.

To Add lot details for a Reagent

1. Double click on the Reagent name, to select from the list of reagents.

2. The selected Reagent will be displayed in the Consumable screen.

XL-200
Operation 7-14

3. Click on the ADD button.

4. On clicking, the following window will be displayed.

XL-200
7-15 Operation

5. Now enter the manufacturer name from the Manufacturer drop down list. See section
Master – Manufacturer for adding manufacturer name in the list.

6. Enter the lot number in the Lot No text box.

7. Enter the expiry date of the reagent in the Expiry Date list.

8. Enter the onboard stability and unit in Onboard Stability text-box and Unit drop down list.

9. The Reagent Type check-boxes will be pre-selected. It is defined while entering the
details for new reagent..

10.Once the above details are entered, click on SAVE to save these details.

11.The reagent will be added and displayed on the grid.

To Edit Details for a Reagent

1. To edit the reagent details, go to Consumable screen, select the Consumable Type as

Reagents and click on the button.

2. On clicking, the following screen will be displayed.

XL-200
Operation 7-16

3. Double click on the desired reagent name from the list of reagents.

4. Click EDIT button.

5. On clicking, the following screen will be displayed for editing the details.

6. Edit the appropriate details and click SAVE.

XL-200
7-17 Operation

7. On clicking, the details will be saved.

8. Following table gives a brief explanation on the different parameters in the grid.

Parameters Description
Manufacturer Select the Reagent Manufacturer from the drop-down list.
A Manufacturer from Master > Mfg screen.
Stock Over Check this Stock Over box when the stock of the consumable
lot is completely utilized.
Lots marked as Stock Over will not appear in the Lot
.
Selection List -

While defining Reagent Positions in the Utility > Reagent


Position screen

While scheduling Calibration and Controls from QC/


Calibration > Schedule QC / Calibration screen.

Note: In case, Stock Over is not ticked for a Lot; then the Lot
will be excluded from the selection list after its expiry date.
This checkbox is available only in Edit mode and not while
adding a Lot.
Lot No Enter the lot number of the reagent.
Lot Status Lot status as Active or Inactive is displayed based on the
Expiry Date defined for the Lot. Expired Lot is displayed as
Inactive.
Expiry Date Select the expiry date of the Reagent lot.
On-board Enter the On-board shelf life of the reagent.
Stability
Unit Select the On-board Stability unit, as appropriate.
Options available are Hours and Days.

Reagent Type Select whether R1 and/or R2 is received for the selected Lot
number.
In case, lot numbers are different for R1 and R2, then define
both the Lots for R1 and R2 appropriately.

Lot details can be edited directly by double-clicking on the required


lot from the main Consumable Screen.

Reagents can be barcoded or non-barcoded. Follow the appropriate procedure for defining samples
through MultiXL software.

Refer section:

Barcoded

Non-barcoded

XL-200
Operation 7-18

7.3.5.2.1 Barcoded

Reagent Barcode scan identifies the reagents and updates the positions of the Barcoded Reagent
bottles placed on the reagent tray.

Steps to register barcoded reagent bottles are as follows:

1. Place the barcoded reagent bottles on the Reagent Tray.

2. Go to Status Monitor > BARCODE SCAN screen.

3. Click on Reagent Barcode Scan button.

On clicking, the available reagents will be scanned and the barcode information is
registered and displayed on the screen.

Column S.N. represents the Position number in the Tray.

Column Reagent Barcode generally shows the barcode number read from bottle.

In some cases, instead of barcode number, following content may be displayed in this
column.

“Checksum Mismatch”: When the checksum digit does not match the calculated
checksum of the bar-code digits.

“Unknown-barcode”: When the digits read are not as per required format or less than
18 digits are read.

“RGT Code Unknown“: When the Reagent Code is not found in the list of Reagents in

XL-200
7-19 Operation

Consumables screen.

“-“: Reagent position is manually defined through Utility > Reagent Position screen.

Reagent(s), their position, Lot number and Expiry date is registered in the system for the
barcoded bottles.

Reagent is identified from the Reagent code mentioned in the barcode pattern and matching
this Reagent Code with the Reagent Code mentioned in the list of reagents in the
Consumables screen.

This updated information is available in the Utility > Reagent Position screen.

Lot number is added in the list of Reagent Lots in Consumables screen.

The Reagent Barcode Scan button will be disabled if the option Reagent
Barcode is unchecked in Settings > System Parameters screen.

4. Alternatively, a batch run can be started with Reagent Barcode scan as a predecessor as
follows.

Select (tick) Reagent Barcode Scan option from the Pre-Run Options (at the top right
hand corner) in Status Monitor > SAMPLE TRAY screen. Click on start (batch) run
button.

Reagent trays will be (barcode) scanned first and barcode information is updated
automatically in the system (refer to point 5 above for details), before starting the batch
run.

Batch run will start only if the reagent positions are available / known for all the test(s)
scheduled in the selected group.

After the scan is over, other details (like Reagent position number, Reagent name,
Reagent type… etc) are updated in the Utility > Reagent Position screen. For example:
See the following screen.
7.3.5.2.2 Non-Barcoded

In Test Loader System, Barcoded reagent bottles will be identified only if


reagent pack is scanned.

In Test Loader System, reagent bottles will be identified by barcode scan


and only permitted number of open channel reagents (user defined) are
allowed to define manually.

Reagent details will be scanned and displayed in Utility > Reagent Position
during pre-run operations or Volume Scan.

Reagent positions for non-barcoded bottles are manually defined through Reagent Position screen as
follows:

Steps to register non-barcoded reagent bottles are as follows:

1. Place reagent bottle in appropriate position on the Reagent tray.

XL-200
Operation 7-20

2. Go to Utility > Reagent Position screen.

3. Select Edit Position check-box. See the following figure.

4. Select the required position to be defined, from the Position list or select the required position
from the screen.

5. Select the reagents name from the Reagent list.

6. Select reagent type (R1/R2) from the Reagent Type list.

7. Select the appropriate bottle type from the Bottle Type list.

8. Select the reagent available lot number from the Lot No. list (Optional).

XL-200
7-21 Operation

9. Click on Save Position Detail.

On clicking, reagent details will be saved to the selected position and displayed in the
positions grid on the screen.

The Rgt Vol (ml) column will show 0.00 ml at the time of definition, and it
will be updated after Reagent Volume Scan or at the first aspiration during

XL-200
Operation 7-22

run.

7.4 Daily routine


This section tell you daily routine procedure which keep your system running for the routine work.

See the following section for more details:

Starting analysis

Interruption and resumption of measurement

User activities during run

Self activities during run

End of day task

7.4.1 Starting analysis


Once the samples, reagents and necessary consumable are scheduled, you can start the run.

1. Go to Status Monitor > SAMPLE TRAY.

2. To start the run (measurement), select the group no. and click on start arrow button,
provided on screen.

Batch run will not be started, if user defined open channels are more than
the permitted limit.

When starting the batch RUN ,if dome is open ( Level 1 and Level 2 ) then pre
run activities will not be started and error message will be displayed in error
display grid.

Ensure to close dome properly before proceeding

During pre RUN activities, if dome is open ( Level 2 ) then all activities which
required ARM movement will be stopped immediately ,alarm and error will be
reported in error display grid. Also further sampling will be paused.

3. Before starting the run, it is recommended to close all other running application from the
computer as it may effect the execution of programmed tests. The following warning message
will be displayed along with the list of application, if any other application is running in

XL-200
7-23 Operation

background.

Clicking on Yes will continue the run and No will stop the run.

4. On start of the batch run, firstly RCT and RGT temperature is checked and the status will be
displayed on the screen.

Secondly, Auto span is performed, if auto span operation fails, again run is stopped (Run will
be stopped only if all wavelengths are out of range).

In case, if auto span operation fails for any wavelengths, user can continue the run with other
remaining wavelengths which are measured as in proper range. For user indication, a
message “Lamp / Optics Value Out Of range for …..” will be displayed with defective
wavelengths and all tests related to those particular wavelengths will be masked and can not
be rescheduled during the same run.

Start time of the run is displayed at top left corner of the screen.

During run, the progress of the measurement is displayed at the right hand side of the
screen.

Results are displayed in the result grid and errors if any are displayed in status message grid at
the bottom of the screen.

XL-200
Operation 7-24

7.4.2 Interruption and resumption of measurement


During run, due to occurrence of some critical errors the run may be stopped in between or paused
temporarily/permanently.

During run, the sample processing can be interrupted and resumed manually, if required.

Following button are provided on the Status Monitor > Sample Tray screen :

Use button to stop the run immediately. On clicking, all the assemblies initialize.

Use button to pause the sampling. If it is clicked, the processed result will be given out
and displayed on the result grid.

Use button to continue the sampling.

On resuming batch run or when the run is completed, a beep will be sounded
by the analyzer.

7.4.3 User activities during run


User can do the following activities when the run is in progress:

Checking online reaction curve

During run, the user can monitor the online reaction curve for the test. See section Reaction Curve
for more details.

Re-scheduling pending and mask tests during run

During run, pending tests / mask tests can be re-schedule by clicking on the free space near the
sample positions. On clicking, the WorkList screen is again displayed, using which the tests can
be selected and then RE-SCHEDULE button can be clicked. (Pending / Mask tests can be
scheduled only if the reagent and test details are available). See section Work List for more
details.

Patient sample entry

During run, emergency patients can be added from the Patient Entry screen by selecting the
option of ‘Emergency’ for that particular patient, entering the sample details and patient details.

During run, normal patients can be added from the Patient Entry screen, entering the sample
details and patient details.

Adding barcoded sample and reagent during run

XL-200
7-25 Operation

Refer section Add Sample and Reagent for more details.

Non barcoded reagent entry

During run, non-barcode reagents can be added from Reagent Position screen on empty reagent
positions. See section Defining non barcoded reagent bottles for more details.

7.4.4 Self activities during run


This section tell you about the self activities which may performed during the run by system.

Progress of the measurement

During run, progress of the measurement is displayed at the right hand side of the screen.

Following are the list of messages may be displayed during the run in the TEST column. The
message indicates that the cycle has skipped due to following reason:

Message Reason

DLUN Dilution schedule

CELBK Dirty cuvette

PAUSE Pause due to error user pause

SKIP Cuvette skipped due to carry over or


Any test requiring special wash solution for the cuvette.

ISE-S Serum ISE cycle schedule

ISE-U Urine ISE cycle schedule

ISE-Skip Cuvette skipped due to dilution for urine ISE schedule

WASH Skip due to wash cycle

COP Cycle skip due to forbidden carry over pair

SWS Special wash

NSWS Special wash absent

Stirrer wash (STRWS) will be performed in the following situations:

During machine initialization process.

During batch run, when all the test schedules are performed and then
next 10 cycles there is no test schedules are remaining, on 11th cycle,
stirrer wash will be performed for R1 and R2.

When reagents defined on multiple positions

In case, there are multiple reagent positions defined for a test:

XL-200
Operation 7-26

During run, the reagent will be aspirated from the reagent (bottle) position having the
nearest expiry date.

In case of multiple reagent bottles having the same expiry date, the reagent will be
aspirated in the order of position.

After the completion of the first batch run, the position of the last sensed in used
reagent bottle will be memorized. On starting the next batch, the previously sensed
reagent bottle position will be used for aspiration.

In case of multiple reagent positions, when volume of the first reagent reaches near dead
volume, then it will automatically switch over to next available reagent for the same test. If
reagent level scan is not done, then it will take previously sensed volume into consideration
while switching to next available reagent position.

In case of last available reagent bottle, if sampling continues till the reagent is absent, then the
remaining schedule of the test will be added in the pending list. In this case, user needs to add
new reagent bottles through Add Reagent button. See section Add Sample and Reagent.

During run, reagent bottle will get discarded after consuming factory filled
reagent volume.

Low reagent volume message

During run or after reagent volume scan, when the number of possible tests for a particular reagent
is less than equals to specified tests in Warn After option in Test Parameter screen, then a low
reagent volume message will be displayed in error message grid. See Warn After option for more
details.

Auto wash reminder

Reminder for auto wash will be displayed on the Status Monitor screen after the end of first batch
run of the day if the user has not performed auto wash for 7 days. Refer command Auto Wash in
section Wash for more information.

When froth is sensed

During run, when the froth is sensed in R1/R2/R3 reagents, following actions can be performed:

When froth is sensed while first reagent aspiration, then that test will move to pending list.

If froth is sensed in three consecutive reagent aspirations, then that reagent bottle position
will be deactivated and the associated test will move to pending list.

In case if reagent position gets deactivated, the reagent will be aspirated


from the next available position, if multiple reagent positions are available
for that test.

Use Refresh Position button to reschedule the reagent bottle positions, which
are deactivated during run. See Refresh Positions for more details.

XL-200
7-27 Operation

Schedules

During run, schedule will be sent as follows:

Blank, Standard, Calibrator, and Control – Test-wise, according to test process


sequence defined in Settings > Test Sequence option

Patient Samples will be performed as follows:

Emergency patient samples will be performed at highest priority. All emergency patient
samples defined before starting the run will be performed in the order of Sample
position number. Emergency samples defined during run will be performed on first-in-
first-out basis.

Then non-emergency Patient Samples will be performed in the order of Sample position
number. However, samples defined during run will be performed on first-in-first-out
basis.

If control interval is defined, control schedules will be sent between patient samples
according to the control interval defined in Test Parameters screen.

Auto error recovery

See section Error Handling for more details.

During calibration run of linear curves

During calibration run of Linear Curves, if the calibration factor is differed by specified limit, a
message will be notified on the QC/Calibration > Calibration screen about the calibration out of
range for the test. Refer Acceptable Limit% in section Calibration for more details.

7.5 End of day task


This section tell you end of day procedure which prepares your analyzer for next day.

To shut down the system:

1. Perform any necessary end-of-day tasks such as maintenance operations.

2. After completion of the tasks, click on Shutdown.

3. Choose the appropriate option from the shutdown screen. See section Shutdown for more
details.

Once you initiate a shutdown, you cannot use the system.

The instrument is designed to run continuously, so there is no need to switch


it off every day, unless that is a requirement in your laboratory.

XL-200
Part

VIII
8-2 Error Handling

8 Error Handling
All the mechanical movements are controlled and monitored by the computer. When a problem
arises, the computer becomes aware of it and generates the visual error message to call the
operator's attention.

In the event of the problem that may affect the performance of the analyzer, the sampling stop or
emergency stop will be executed. In the case of sampling stop mode, the analyzer carries on and
completes the processing of the sample that is not affected by the problem. In the case of problem
that may affect the entire measurements of sample, the emergency stop will be executed.

Error recovery is an ability of software or equipment in which the errors will be automatically
recovered without affecting the sample run. During run, when the error is encountered, system will
first identify whether the current error falls under error recovery category or not. If yes, then the
system will initiate the recovery for that particular error, without run pause. The test affected due to
this error shall be moved to pending and auto rescheduled (if Auto Resch option is selected). In
case, if error is not recovered, then depending upon the severity of the error the run will be stopped or
paused. Possible errors which comes under auto error recovery category are listed in section List of
errors.

Error Log screen will displays all the errors occurred on the analyzer during the test run or service
check operation. This data is generally useful for servicing/diagnostic purposes.

Problem may arise, which is not monitored by the computer. Any alarm message may not be
indicated on the display for such a problem. Such a problem includes abrasion of parts, leakage in
the sampling system, etc. When this type of problem occurs, decide whether the processing of
sample is carried on or the measurement is terminated, considering that such problem may result in
damage to the analyzer or erroneous outcome of measurements.

When user clicks on Start Run button on Status Monitor, if any error is detected
during initialization of the instrument then the error message will be displayed in
the error grid on the Screen. In such case, the instruments will stop. The user has
to take the corrective action.

See the following sections for more details:

Flag list

List of errors

8.1 List of Errors


Assembl Error Flags Error Possible Corrective Action to Auto
y Code Descripti Failure be Taken Error
on Recover
y and
Resche
dule?
Arm 11 @R1 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Trough to nothing is obstructing
Reagent 1 Arm rotation.
position

XL-200
Error Handling 8-3

2. Interface 2. Then switch ON the


board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
inner> Execute
commands.
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer.
and its
connection
Arm 12 @R1 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Reagent 1 nothing is obstructing
position to Arm rotation.
Trough
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
inner> <Reagent outer/
inner to trough> Execute
commands.
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer.
and its
connection
4. If the initialization or
VOD generation fails,
call the Service
Engineer.
Arm 13 Arm VOD 1. VOD Opto 1. Check the arm No
error Sensor alignment in [Service
Check]. If it is hitting at
the edge, then align the
probe using the
calibration facility.
(During 2. The 2. Remove the cover of
service connectors the arm and check and
check) clean the VOD opto.
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during the probe gently to cut
Reagent 1 the VOD opto so as to
operation generate a VOD Error
will be generated and
Arm initializes.

XL-200
8-4 Error Handling

4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 14 @R1 Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move SPT arm
Trough position up and down by hand
during optos, up/ and make sure that
reagent 1 down optos nothing is obstructing
operation and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down 4 . If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connections
Arm 15 @R1 Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Reagent 1 optos instrument. Check if the
position error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 16 @R1 Arm Up 1. Arm VOD 1. Switch OFF the Yes


error - opto, arm analyzer; Move SPT arm
Reagent 1 position up and down by hand
position optos, up/ and make sure that
down optos nothing is obstructing
and rotation SPT movement
optos

XL-200
Error Handling 8-5

2. Probe 2. Then switch ON the


assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down 4. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connections
Arm 17 Arm 1. Arm 1. Switch OFF the No
rotation position Opto analyzer; Rotate arm by
error signal hand and make sure that
nothing is obstructing
Arm rotation
(During 2. Interface 2. Then switch ON the
service board and its instrument; Go to
check) connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 18 Arm up/ 1. Arm VOD 1. Switch OFF the No
down error opto, arm analyzer; Move arm up
(During position and down by hand and
service optos, up/ make sure that nothing
check) down optos is obstructing Arm
and rotation movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute <Arm Up>
Execute commands

XL-200
8-6 Error Handling

3. Interface 3. If the initialization or


card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 19 @R1 Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Trough optos instrument. Check if the
during error comes again
reagent 1
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 1A !R1 Arm VOD 1. VOD Opto 1. Check the arm If same
error - Sensor alignment in [Service reagent
Reagent Check]. If it is hitting atis
Pos. the edge, then align the present
probe using the calibrate in next
facility. available
position
2. The 2. Remove the cover of
then
connectors the arm and check and
associat
clean VOD opto
ed tests
3. Arm 3. Go to Service Check: get auto
position in Arm Menu. Click on reschedu
Reagent tray <Initialize> button. Push led else
at R1 position the probe gently to cut it will
the VOD opto so that move to
VOD Error will be pending
generated and Arm list. It
initializes. can
reschedu
4. If the initialization or
led using
VOD generation fails,
Refresh
call the Service Engineer
Position
button.
Arm 1A !D Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Diluent Check]. If it is hitting at
Pos. the edge, then align the

XL-200
Error Handling 8-7

probe using the calibrate


facility.

2. The 2. Remove the cover of


connectors the arm and check and
clean VOD opto
3. Arm 3. Go to Service Check:
position in Arm Menu. Click on
Reagent tray <Initialize> button. Push
at Diluent the probe gently to cut
position the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 1B/ R1** R1 Liquid 1. Liquid Level 1. Call the Service No
LLD Level Detector Engineer
found
different at
Pos.
2. Actual 2. Physically check the
liquid level liquid in the reagent
may be bottle
different from
the previous
liquid level
Arm 1C !R1! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align the
Reagent 1 probe using the calibrate
operation facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during the probe gently to cut
Reagent 1 the VOD opto so that
operation VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 1C !D! Arm VOD 1. VOD Opto 1. Check the arm No
error – Sensor alignment in [Service
Dilution Check]. If it is hitting at
pos. the edge, then align the
probe using the calibrate

XL-200
8-8 Error Handling

facility.

2. The 2. Remove the cover of


connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during the probe gently to cut
Reagent 1 the VOD opto so that
operation VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 1D/1 R1* Reagent 1 1. Reagent is 1. Place the reagent at No
D* absent - not kept in the the required reagent
Pos. reagent bottle position
or reagent
bottle not kept
at the defined
position
2. Reagent is 2. Check the level of
below the Reagent and ensure that
Dead volume it is above the Dead
volume
3. Arm 3. Call Service Engineer
position in
reagent tray
4. LLS circuit
and its
connector
problem
Arm 1D/1 D* Diluent 1. Reagent is 1. Place the reagent at No
D* absent - not kept in the the required reagent
Pos. reagent bottle position
or reagent
bottle not kept
at the defined
position
2. Reagent is 2. Check the level of
below the Reagent and ensure that
Dead volume it is above the Dead
volume
3. Arm 3. Call Service Engineer
position in
reagent tray
4. LLS circuit
and its
connector

XL-200
Error Handling 8-9

problem

Arm 1E @R1 Arm 1. Sample 1. Switch OFF the No


Initialize position Opto analyzer; Rotate arm by
Rotational signal hand and make sure that
error nothing is obstructing
Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
command
3. Up/Down 3. If the initialization
and rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 1F @R1 Arm 1. Arm VOD 1. Switch OFF the No
Initialize opto, arm analyzer; Move SPT arm
Up/Down position up and down by hand
error optos, up/ and make sure that
down optos nothing is obstructing
and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm BB !S Arm VOD 1. Arm VOD 1. Switch OFF and then No
error at opto, arm switch ON the
ISE unit position instrument. Check if the
optos, up/ error comes again
down optos
and rotation
optos
2. Probe 2. Remove the cover of
assembly the sample arm and
check and clean
obstacle opto

XL-200
8-10 Error Handling

3. Interface 3. Check the Arm


card and its assembly
connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 21 @R2 Arm 1. Sample 1. Switch OFF the Yes


Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Trough to nothing is obstructing
Reagent 2 Arm rotation
position
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 22 @R2 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Reagent 2 nothing is obstructing
position to Arm rotation
R2
2. Interface 2. Then switch ON the
Cuvette
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
<Reagent outer/inner to
R2 cuvette> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 23 @R2 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - R2 signal hand and make sure that
Cuvette to nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]

XL-200
Error Handling 8-11

menu; Give <Initialize>


and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
<Reagent outer/inner to
R2 cuvette> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 24 @R2 Arm Up 1. Arm VOD 1. Switch OFF the Yes
error - opto, arm analyzer; Move SPT arm
Trough position up and down by hand
during optos, up/ and make sure that
Reagent 2 down optos nothing is obstructing
operation and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 25 @R2 Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Reagent 2 optos instrument. Check if the
position error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

XL-200
8-12 Error Handling

Arm 26 @R2 Arm Up 1.ARM up/ 1. Switch OFF the Yes


error - down opto, analyzer; Move SPT arm
Reagent 2 ARM position up and down by hand
position opto, ARM and make sure that
Home opto, nothing is obstructing
ARM direction SPT movement
opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 27 @R2 Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Cuvette optos instrument. Check if the
during error comes again
Reagent 2
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 28 @R2 Arm Up 1. Arm VOD 1. Switch OFF the No


error - R2 opto, arm analyzer; Move SPT arm
Cuvette position up and down by hand
optos, up/ and make sure that
down optos nothing is obstructing
and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]

XL-200
Error Handling 8-13

menu; Give <Initialize>


and <Arm Up> Execute
<Trough to R2 cuvette>
Execute <Arm Down>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 29 @R2 Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Trough optos instrument. Check if the
during error comes again
Reagent 2
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 2A !R2 Arm VOD 1. VOD Opto 1. Check the arm No


error – Sensor alignment in [Service
Reagent Check]. If it is hitting at
Pos. the edge, then align the
probe using the calibrate
facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Reagent <Initialize> button. Push
tray at R2 the probe gently to cut
position the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,

XL-200
8-14 Error Handling

call the Service Engineer

Arm 2B R2! Arm VOD 1. VOD Opto 1. Check the arm No


error - Sensor alignment in [Service
Cuvette Check]. If it is hitting at
during the edge, then align the
Reagent 2 probe using the
operation calibration facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Cuvette <Initialize> button. Push
during the probe gently to cut
Reagent 2 the VOD opto so that
operation VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 2C !R2! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align the
Reagent 2 probe using the
operation calibration facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during the probe gently to cut
Reagent 2 the VOD opto so that
operation VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 2D/2 R2* Reagent 1. Reagent is 1. Place the reagent at If same
D* absent – not kept in the the required reagent reagent
Pos. reagent bottle position is
or reagent present
bottle not kept in the
at the defined next
position available
position,
then the
associat

XL-200
Error Handling 8-15

2. Reagent is 2. Check the level of ed tests


below the Reagent and ensure that get auto
Dead volume it is above the Dead reschedu
volume led else
it will
3. Arm 3. Call Service Engineer
move to
position in
pending
reagent tray
list. It
4. LLS circuit can
and its reschedu
connector led using
problem Refresh
Position
button.
Arm 2E R2** R2 Liquid 1. Liquid Level Call the Service No
Level Detector Engineer
found
different at
Pos.
Arm 1F/2 @R2 Arm 1. Arm VOD 1. Switch OFF the No
F/ Rotational opto, arm analyzer; Move SPT arm
3F Error position up and down by hand
Trough to optos, up/ and make sure that
Cuvette down optos nothing is obstructing
and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute commands.
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 31 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Trough to nothing is obstructing
Sample Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute

XL-200
8-16 Error Handling

commands

3. Up/Down 3. If the initialization or


and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 3A6/ !DILN Arm 1. Sample 1. Switch OFF the No
3A7 Rotational position Opto analyzer; Rotate arm by
Error - signal hand and make sure that
Trough to nothing is obstructing
Dilution Arm rotation
Cuvette
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 32 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Sample to nothing is obstructing
Cuvette Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 320/3 @S Arm 1. Sample 1. Switch OFF the Yes
21/32 Rotational position Opto analyzer; Rotate arm by
2 Error - signal hand and make sure that
Sample to nothing is obstructing
Cuvette Arm rotation

XL-200
Error Handling 8-17

2. Interface 2. Then switch ON the


board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 323/3 @S Arm 1. Sample 1. Switch OFF the Yes
24/32 Rotational position Opto analyzer; Rotate arm by
5 Error - signal hand and make sure that
Sample to nothing is obstructing
ISE Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 326 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
Error - signal hand and make sure that
Dilution nothing is obstructing
Cuvette to Arm rotation
Cuvette
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 327 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
Error - signal hand and make sure that
Dilution nothing is obstructing

XL-200
8-18 Error Handling

Cuvette to Arm rotation


ISE

2. Interface 2. Then switch ON the


board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 328 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Reagent 1 nothing is obstructing
position to Arm rotation
Cuvette
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 33 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - signal hand and make sure that
Cuvette to nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer

XL-200
Error Handling 8-19

and its
connection

Arm 330/3 @S Arm 1. Sample 1. Switch OFF the Yes


31/33 Rotational position Opto analyzer; Rotate arm by
2 Error - or Home opto hand and make sure that
Cuvette to signal nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 333/3 @S Arm 1. Sample 1. Switch OFF the Yes
34/33 Rotational position Opto analyzer; Rotate arm by
5 Error - or Home opto hand and make sure that
ISE to signal nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 336 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
Error - or Home opto hand and make sure that
Cuvette to signal nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]

XL-200
8-20 Error Handling

menu; Give <Initialize>


and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 337 @S Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
Error - or Home opto hand and make sure that
ISE to signal nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 338 Arm 1. Sample 1. Switch OFF the Yes
Rotational position Opto analyzer; Rotate arm by
error - or Home opto hand and make sure that
Cuvette to signal nothing is obstructing
Trough Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to sample
outer> Execute
<Sample Outer to R1
Cuvette> Execute <R1
Cuvette to Trough>
Execute commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer

XL-200
Error Handling 8-21

and its
connection

Arm 34 @S Arm Up 1. Arm VOD 1. Switch OFF the Yes


error - opto, arm analyzer; Move arm up
Trough position and down by hand and
during optos, up/ make sure that nothing
sample down optos is obstructing Arm
operation and rotation movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 356/3 @S Arm Down 1. Sample 1. Switch OFF the No
57 Error - position Opto analyzer; Rotate arm by
Dilution signal hand and make sure that
Cuvette nothing is obstructing
Arm rotation
2. Interface 2. Then switch ON the
board and its instrument; Go to
connectors [Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to reagent
outer> Execute
commands
3. Up/Down 3. If the initialization or
and rotation rotation fails, call Service
stepper motor Engineer
and its
connection
Arm 35 @S Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON
Sample optos
position
2. Interface Check the instrument.
card and its Check if the error comes
connector again
3. Probe goes 2. Remove the cover of
down but the sample arm and

XL-200
8-22 Error Handling

doesn’t find check and clean


LLS signal obstacle opto
due to
problem in
LLS card or
its connector
4. Probe 3. Check the Arm
assembly assembly
4. Go to [Service Check:
Arm] menu; Give
<Initialize> and <Arm
Up> Execute <Arm
trough to Sample outer>
Execute <Arm Down>
Execute commands
5. If still it is giving error,
call Service Engineer

Arm 36 @S Arm Up 1. Arm VOD 1. Switch OFF the Yes


error - opto, arm analyzer; Move SPT arm
Sample position up and down by hand
position optos, up/ and make sure that
down optos nothing is obstructing
and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to Sample
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 366/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No
67 Error - down opto, analyzer; Move SPT arm
Dilution ARM position up and down by hand
Cuvette opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>

XL-200
Error Handling 8-23

C) and <Arm Up> Execute


<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 37 @S R1 down 1. Arm VOD 1. Switch OFF and then Yes
error in opto & arm switch ON the
cuvette optos instrument. Check if the
error comes again
2. Interface 2. Remove the cover of
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 370/3 @S Arm Down 1.ARM up/ 1. Switch OFF the No


71/37 Error - down opto, analyzer; Move SPT arm
2 Cuvette ARM position up and down by hand
opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer

XL-200
8-24 Error Handling

4. Up/down
and rotation
stepper motor
and its
connections
Arm 373/3 @S Arm Down 1.ARM up/ 1. Switch OFF the No
74/37 Error - down opto, analyzer; Move SPT arm
5 ISE ARM position up and down by hand
opto, ARM and make sure that
Home opto, nothing is obstructing
ARM direction SPT movement
opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 376 @S Arm Down 1.ARM up/ 1. Switch OFF the No
Error - down opto, analyzer; Move SPT arm
Cuvette ARM position up and down by hand
opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections

XL-200
Error Handling 8-25

Arm 377 @S Arm Down 1.ARM up/ 1. Switch OFF the No


Error - down opto, analyzer; Move SPT arm
ISE ARM position up and down by hand
opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 378 Arm Down 1.ARM up/ 1. Switch OFF the No
Error - down opto, analyzer; Move SPT arm
Cuvette ARM position up and down by hand
opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector menu; Give <Initialize>
(FRC) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 38 @S Arm Up 1. Arm VOD 1. Switch OFF the No
error - opto, arm analyzer; Move SPT arm
Sample position up and down by hand
Cuvette optos, up/ and make sure that
down optos nothing is obstructing

XL-200
8-26 Error Handling

and rotation SPT movement


optos

2. Probe 2. Then switch ON the


assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm trough to Sample
outer> Execute
<Sample outer to R1
cuvette> Execute <Arm
Down in R1 cuvette>
Execute <Arm Up>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 380/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No
81/38 Error - down opto, analyzer; Move SPT arm
2/ Cuvette ARM position up and down by hand
386/3 opto ,ARM and make sure that
88 Home opto nothing is obstructing
,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 383/3 @S Arm Up 1.ARM up/ 1. Switch OFF the No
84/38 Error - down opto, analyzer; Move SPT arm
5 /38 ISE ARM position up and down by hand
7 opto ,ARM and make sure that
Home opto nothing is obstructing
,ARM SPT movement

XL-200
Error Handling 8-27

direction opto

2. Arm 2. Then switch ON the


assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm
Up> Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 39 @S Arm Down 1. Arm VOD 1. Switch OFF and then Yes
error - opto & arm switch ON the
Trough optos instrument. Check if the
during error comes again
sample
2. Interface 2. Remove the cover of
operation
card and its the sample arm and
connector check and clean
obstacle opto
3. Probe goes 3. Check the Arm
down but assembly
doesn’t find
LLS signal
due to
problem in
LLS card or
its connector
4. Probe 4. If still it is giving error,
assembly call Service Engineer

Arm 398 Arm Down 1.ARM up/ 1. Switch OFF the No


error - down opto, analyzer; Move SPT arm
Trough ARM position up and down by hand
during opto ,ARM and make sure that
Cuvette Home opto nothing is obstructing
wash ,ARM SPT movement
direction opto
2. Arm 2. Then switch ON the
assembly instrument; Go to
opto [Service Check: Arm]
connector(FR menu; Give <Initialize>
C) and <Arm Up> Execute
<Arm trough to Reagent
outer> Execute <Arm
Down> Execute <Arm

XL-200
8-28 Error Handling

Up> Execute commands

3. Interface 3. If the initialization or


card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Arm 3A !S Arm VOD 1. VOD Opto 1. Check whether the When
error - Sensor selected option is tube this error
Sample and instead of tube a occurs,
Pos. cup is placed tests
associat
2. The 2. Check the Arm
ed with
connectors alignment in [Service
that
Check]. If it is hitting at
sample
the edge, then align the
will move
probe using the calibrate
to
facility.
pending
3. Sample 3. Remove the cover of list. It
arm position the sample arm and can be
in Sample check and clean VOD reschedu
tray opto led using
Work
4. Go to Service Check:
List
Arm Menu. Click on
button.
<Initialize> button. Push
the Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
5. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3A6/ !DILN Arm VOD 1. VOD Opto 1. Check the Arm No
3A7 error - Sensor alignment in [Service
Dilution Check]. If it is hitting at
Cuvette. the edge, then align the
probe using the calibrate
facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Dilution <Initialize> button. Push
cuvette the probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm

XL-200
Error Handling 8-29

initializes.

4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B S! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
During Check]. If it is hitting at
Sample the edge, then align the
dispense probe using the calibrate
facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Dispense <Initialize> button. Push
cuvette the probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B DILN! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
During Check]. If it is hitting at
Diluted the edge , then align the
Sample probe using the calibrate
dispense facility.
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Dispense <Initialize> button. Push
cuvette during the probe gently to cut
dilution the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B0/ !S Arm VOD 1. VOD Opto 1. Check whether the No
3B1/ Error - Sensor selected option is tube
3B2/ Cuvette and instead of tube a
cup is placed

XL-200
8-30 Error Handling

2. The 2. Check the Arm


connectors alignment in [Service
Check]. If it is hitting at
the edge, then align the
probe using the calibrate
facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in Sample check and clean VOD
tray opto
4. Go to Service Check:
Arm Menu. Click on
<Initialize> button. Push
the Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
5. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B3/ S! Arm VOD 1. VOD Opto 1. Check whether the No
3B4/ Error - Sensor selected option is tube
3B5/ ISE and instead of tube a
3B7 cup is placed
2. The 2. Check the Arm
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align the
probe using the calibrate
facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in Sample check and clean VOD
tray opto
4. Go to Service Check:
Arm Menu. Click on
<Initialize> button. Push
the Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
5. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B6 !DILN Arm VOD 1. VOD Opto 1. Check whether the No
Error - Sensor selected option is tube
Cuvette and instead of tube a
cup is placed

XL-200
Error Handling 8-31

2. The 2. Check the Arm


connectors alignment in [Service
Check]. If it is hitting at
the edge, then align the
probe using the calibrate
facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in cuvette check and clean VOD
during dilution opto
4. Go to Service Check:
Arm Menu. Click on
<Initialize> button. Push
the Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
5. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3B8 Arm VOD 1. VOD Opto 1. Check whether the No
Error - Sensor selected option is tube
Cuvette and instead of tube a
during cup is placed
Cuvette
2. The 2. Check the Arm
wash
connectors alignment in [Service
Check]. If it is hitting at
the edge, then align the
probe using the calibrate
facility.
3. Sample 3. Remove the cover of
arm position the sample arm and
in cuvette check and clean VOD
during cuvette opto
wash
4. Go to Service Check:
Arm Menu. Click on
<Initialize> button. Push
the Probe gently to cut
the VOD opto so that
VOD Error will be
generated and Arm
initializes.
5. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3C !S! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align the
Sample probe using the calibrate
operation facility.

XL-200
8-32 Error Handling

2. The 2. Remove the cover of


connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during sample the probe gently to cut
operation the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3C !DILN! Arm VOD 1. VOD Opto 1. Check the arm No
error - Sensor alignment in [Service
Trough Check]. If it is hitting at
during the edge, then align the
Sample probe using the calibrate
Dilution facility.
operation
2. The 2. Remove the cover of
connectors the arm and check and
clean VOD opto
3. Sample 3. Go to Service Check:
arm position Arm Menu. Click on
in Trough <Initialize> button. Push
during sample the probe gently to cut
operation the VOD opto so that
VOD Error will be
generated and Arm
initializes.
4. If the initialization or
VOD generation fails,
call the Service Engineer
Arm 3D S* Sample 1. Sample is 1. Place the sample at During
absent - not kept in the the required sample run,
Pos. sample tube / position when
cup at that this error
particular occurs,
position all tests
associat
ed with
that
sample
moved to
pending
list. It
can be
reschedu
led using
Work
List
button in

XL-200
Error Handling 8-33

2. Sample 2. Check the level of Status


tube / cup Sample and ensure that Monitor
absent at that it is above the Dead screen.
particular volume
position
3. LLS circuit 3. Call Service Engineer
and its
connector
problem
4. Sample is
below the
Dead volume
5. Arm
position in
sample tray
Arm 3E S** Sample 1. Liquid Level Call Service Engineer No
Liquid Detector The test of the Patient
Level Sample will be added to
found Pending list.
different at
Pos.
Arm 3F @S Arm 1. Arm VOD 1. Switch OFF the No
Initialize opto, arm analyzer; Move SPT arm
Up/Down position up and down by hand
error optos, up/ and make sure that
down optos nothing is obstructing
and rotation SPT movement
optos
2. Probe 2. Then switch ON the
assembly instrument; Go to
[Service Check: Arm]
menu; Give <Initialize>
and <Arm Up> Execute
<Arm Down in Trough>
Execute commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector call Service Engineer
4. Up/down
and rotation
stepper motor
and its
connections
Syringe 41 R1 1. Syringe 1. Switch OFF the No
Syringe position opto analyzer; Move the
Initialize Syringe up and down by
error hand and make sure that
nothing is obstructing
the movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:

XL-200
8-34 Error Handling

Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 42 @R1 R1 1. Syringe 1. Switch OFF the Yes
Syringe position opto analyzer; Move the
Up/Down Syringe up and down by
error hand and make sure that
nothing is obstructing
the movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
4A Reagent 1 1.Communicat 1.Get PC checked by IT- Yes
informatio ion data lost. team, especially RAM,
n not 2.Test Hard-disk for Bad
transmitte schedule data sectors, 2.Anti-virus
d is not proper check, etc. are
e.g.R1 volume compliant to PC
has been specification.
sent/received 3.Re-load OS Image on
without R1 PC.
position. 4.Repeat the same run
and observe the
repeatability.
5.Share feedback
5A Reagent 2 1.Communicat 1.Get PC checked by IT- Yes
informatio ion data lost. team, especially RAM,
n not 2.Test Hard-disk for Bad
transmitte schedule data sectors, 2.Anti-virus
d is not proper check, etc. are
e.g.R1 volume compliant to PC
has been specification.
sent/received 3.Re-load OS Image on
without R1 PC.
position. 4.Repeat the same run
and observe the
repeatability.
5.Share feedback

XL-200
Error Handling 8-35

Arm 44 @R1 Up Opto 1. Up Optos Call Service Engineer No


failure 2. Optos
while connectors
Reagent 1
3. Opto
or sample
Supply
action

54 @R2 Up Opto 1. Up Optos Call Service Engineer No


failure 2. Optos
while connectors
Reagent 2
3. Opto
action
Supply
Stirrer B5 @STR1 Up Opto 1. Up Optos Call Service Engineer No
failure 2. Optos
while connectors
stirrer
3. Opto
action for
Supply
Reagent 1
C5 @STR2 Up Opto 1. Up Optos Call Service Engineer No
failure 2. Optos
while connectors
stirrer
3. Opto
action for
Supply
Reagent 2
Syringe 52 @R2 R2 1. Syringe 1. Switch OFF the Yes
Syringe position opto analyzer; Move the
Up/Down Syringe up and down by
error hand and make sure that
nothing is obstructing
the movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 61 @SY Syringe 1. Syringe 1. Switch OFF the No
R Initialize position opto analyzer; Move the
error Syringe up and down by
hand and make sure that
nothing is obstructing
the movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and

XL-200
8-36 Error Handling

<Aspirate/Dispense>
commands

3. Syringe up/ 3. If the initialization or


down motor aspirate/dispense
movement fails, call
Service Engineer
Syringe 62 Sample 1. Syringe 1. Switch OFF the No
Syringe position opto analyzer; Move the
Up/Down Syringe up and down by
error hand and make sure that
nothing is obstructing
the movement
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check:
Syringe]; Give
<Initialize> and
<Aspirate/Dispense>
commands
3. Syringe up/ 3. If the initialization or
down motor aspirate/dispense
movement fails, call
Service Engineer
66 CD Clot Sample Check the condition No
Detected condition of the actual
at Pos is not OK sample. If sample is
Blockage found OK then
in probe check for probe
due to blockage. If probe is
obstacle found blocked, then
or actual clean the probe.
sample If sample found not
clot. OK, then change
the sample.
Reagent 71 RGT1 Reagent 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate RGT by
Initialize assembly of hand and make sure that
Rotational RGT tray nothing is obstructing
error the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check: Reagent
Tray]; Give <Initialize>
command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Reagent 72 RGT1 Reagent 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate RGT by
Rotational assembly of hand and make sure that
error RGT tray nothing is obstructing

XL-200
Error Handling 8-37

during run the rotation

2. Stepper 2. Then, switch ON the


motor and its instrument; Go to
connections [Service Check: Reagent
Tray]; Give <Initialize>
command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Reagent 7F RGT3 RGT ARM 1. Make sure that arm No
Tray Interlock assembly UP assembly is not down in
error opto & RGT tray during service
Direction opto. check for reagent i.e.
service command
1) RGT initialize 2) RGT
tray rotate to “X”
position. If arm
assembly is not down
then checkup opto &
direction opto signal.
2. Check opto
connectors are
connected properly or
not.
Reagent V1 -- “Bottle 1. Scanned Decrease the Reagent No
Tray over-filled Reagent volume at the required
at Pos. volume is position
N“, where more than
N= 47ml for Large
Position bottle
No.
2. Scanned Decrease the Reagent
Reagent volume at the required
volume is position
more than 23
ml for Small
bottle
Sample 81 -- Sample 1. Position 1. Switch OFF the No
Tray tray opto analyzer; Rotate ASP by
Initialize assembly of hand and make sure that
Rotational ASP nothing is obstructing
error the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check: Sample
Tray]; Give <Initialize>
command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector

XL-200
8-38 Error Handling

Sample 82 ASP2 Sample 1. Position 1. Switch OFF the No


Tray tray opto analyzer; Rotate ASP by
Rotational assembly of hand and make sure that
error ASP nothing is obstructing
during run the rotation
2. Stepper 2. Then, switch ON the
motor and its instrument; Go to
connections [Service Check: Sample
Tray]; Give <Initialize>
command.
3. Interface 3. If initialization fails,
card and its call Service Engineer
connector
Sample 8F ASP3 ASP ARM 1. Make sure that arm No
Tray Interlock assembly UP assembly is not down in
Error opto & ASP tray during service
Direction opto check for ASP tray i.e.
& ARM home service command 1)
opto ASP initialize 2) ASP
tray rotate to “X” position

2. Check opto
connectors are
connected properly or
not.
RCT Tray 91 RCT1 RCT tray 1. Position 1. Switch OFF the No
Initialize opto analyzer; Rotate RCT by
Rotational assembly of hand and make sure that
error RCT tray nothing is obstructing
the rotation
2. Stepper 2. Then switch ON the
motor and its instrument; Go to
connections [Service Check: RCT
Tray]; Give <Initialize>
command
3. Interface 3. If initialization fails,
card and its otherwise call Service
connector Engineer
4. Arms are
down in RCT

RCT Tray 92 RCT2 RCT tray 1. Position 1. Switch OFF the No


Rotational opto analyzer; Rotate RCT by
error assembly of hand and make sure that
during run RCT tray nothing is obstructing
the rotation
2. Stepper 2. Then switch ON the
motor and its instrument; Go to
connections [Service Check: RCT
Tray]; Give <Initialize>
command

XL-200
Error Handling 8-39

3. Interface 3. If initialization fails,


card and its otherwise call Service
connector Engineer
4. Arms are
down in RCT

Dome 97 DA Dome Dome opened Close the dome No.


Level 2 abruptly above properly.
opened level 2
abruptly.
Schedule
d
skipped.
System 98 SYS! SYS error 1. Error in 1. Test will be added in No
Error communicatio pending list. Reschedule
n between PC the test and perform.
and Analyzer
during
schedule
transmission.
2. In case frequent
occurrence of error,
contact Service
Engineer.
Hardware 99 HErr Hardware Check the Take the corrective No
Error Error assembly action for the error which
which gave occurred prior to
error prior to Hardware Error
Hardware
Error.
RCT Tray 9F RCT3 RCT ARM 1. Make sure that arm No
Interlock assembly UP assembly is not down in
error opto & RCT tray during service
Direction opto check for RCT tray i.e.
& ARM home service command
opto 1) RCT initialize
2) RCT tray rotate to “X”
position
2. Check opto
connectors are
connected properly or
not.
CRU A1 @CR CRU 1. CRU 1. Switch OFF the No
U Initializati Position opto analyzer; Move CRU up
on error signal and down by hand and
make sure that nothing
is obstructing the CRU
movement
2. RCT 2. Then switch ON the
Position opto instrument; Go to
signals [Service Check: CRU
Unit]; Give <Initialize>
and <Up/down>

XL-200
8-40 Error Handling

commands

3. Interface 3. If the initialization or


card and its up/down movement fails,
connector otherwise call Service
Engineer
4. Stepper
motor and its
connections
5. RCT
alignment
CRU A2 @CR CRU Up/ 1. CRU 1. Switch OFF the No
U Down Position opto analyzer; Move CRU up
error signal and down by hand and
make sure that nothing
is obstructing the CRU
movement
2. RCT 2. Then switch ON the
Position opto instrument; Go to
signals [Service Check: CRU
Unit]; Give <Initialize>
and <Up/down>
commands
3. Interface 3. If the initialization or
card and its up/down movement fails,
connector otherwise call Service
Engineer
4. Stepper
motor and its
connections
5. RCT
alignment
CRU A3 @CR CRU CRU down 1. Make sure the down No
U Down opto opto is working i.e. CRU
Opto Fail down opto LED is ON
when OPTO is open and
CRU down opto LED is
OFF when CRU opto is
cut by interrupter. Also
ensure that the logic low
signal is reaching to
CPU board when opto is
open i.e. LED is ON &
logic high (3.3v) signal
reaches the CPU board
when opto is cut i.e.
LED is OFF.
2. Check opto
connectors are
connected properly or
not.

XL-200
Error Handling 8-41

CRU A4 @CR CRU Up CRU up opto 1. Make sure the up No


U Opto Fail opto is working i.e. CRU
up opto led is ON when
OPTO is open and CRU
up opto led is OFF
when CRU opto is cut by
interrupter. Also ensure
that the logic low signal
is reaching to CPU
board when opto is open
i.e. LED is ON & logic
high (3.3v) signal
reaches the CPU board
when opto is cut i.e.
LED is OFF.
2. Check opto
connectors are
connected properly or
not.
CRU AF @CR CRU RCT_POSITIO 1. Make sure No
U Interlock N_OPTO and RCT_position opto is ON
Error CRU_UP_OP and CRU_UP_OPTO is
TO and OFF and
CRU_DOWN_ CRU_DOWN_OPTO is
OPTO ON before CRU goes
down in RCT when down
command is executed
during service check.
2) Ensure RCT position
opto is ON when cru
goes down in RCT during
run.
2. Check opto
connectors are
connected properly or
not.
Stirrer B1 @STR Stirrer Up/ 1. Position 1. Switch OFF the Yes
1 Down opto analyzer; Rotate stirrer
error for assembly of by hand and make sure
Reagent 1 stirrer that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to [Se
connector rvice Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<Down in Cuvette>
Execute <Stirrer Up>
Execute <R1 Cuvette to
Trough> commands

XL-200
8-42 Error Handling

3. Stepper 3. If the initialization or


motor rotation fails, call Service
Engineer
Stirrer B2 @STR Stirrer 1. Position 1. Switch OFF the Yes
1 Rotational opto analyzer; Rotate stirrer
error for assembly of by hand and make sure
Reagent 1 stirrer that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to Trough>
commands.
3. Stepper 3. If the initialization or
motor rotation fails, call Service
Engineer
Stirrer B3 -- Stirrer Up/ 1. Position 1. Switch OFF the No
Down and opto analyzer; Rotate stirrer
rotation assembly of by hand and make sure
recovery stirrer that nothing is
fail for obstructing the rotation
Reagent 1
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to Trough>
commands
3. Stepper 3. If the initialization or
motor rotation fails, call Service
Engineer
Stirrer B4 -- RCT 1. Position 1. Switch OFF the No
rotational opto analyzer; Rotate stirrer
error due assembly of by hand and make sure
to stirrer stirrer that nothing is
interlock obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R1 Cuvette> Execute
<R1 Cuvette to Trough>
commands

XL-200
Error Handling 8-43

3. Stepper 3. If the initialization or


motor rotation fails, call Service
Engineer
R1 Arm 64 -- Recoverin Due to -- Yes
g. R1 assembly
skipped error
and re-
scheduled
Stirrer BF @STR Stirrer RCT_POSITIO Make sure No
3 Interlock N_OPTO and RCT_POSITION_OPTO
Error STR_HOME_ is ON when stirrer down
OPTO and in cuvette command is
STR_DIRECTI executed during service
ON_OPTO' check
2. Check opto
connectors are
connected properly or
not..
Stirrer C1 @STR Stirrer Up/ 1. Position 1. Switch OFF the Yes
2 Down opto analyzer; Rotate stirrer
error for assembly of by hand and make sure
Reagent 2 stirrer that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R2 Cuvette> Execute
<Down in Cuvette>
Execute <Stirrer Up>
Execute <R2 Cuvette to
Trough> commands
3. Stepper 3. If the initialization or
motor rotation fails, call Service
Engineer
Stirrer C2 @STR Stirrer 1. Position 1. Switch OFF the Yes
2 Rotational opto analyzer; Rotate stirrer
error for assembly of by hand and make sure
Reagent 2 stirrer that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R2 Cuvette> Execute
<R2 Cuvette to Trough>
commands

XL-200
8-44 Error Handling

3. Stepper 3. If the initialization or


motor rotation fails, call Service
Engineer
Stirrer C3 -- R2 Stirrer 1. Position 1. Switch OFF the No
Rotational opto analyzer; Rotate stirrer
Error assembly of by hand and make sure
stirrer that nothing is
obstructing the rotation
2. Interface 2. Then switch ON the
card and its instrument; Go to
connector [Service Check: Stirrer];
Give <Initialize> and
<Stirrer Up> Execute
<Stirrer Arm Trough to
R2 Cuvette> Execute
<R2 Cuvette to Trough>
commands
3. Stepper 3. If the initialization or
motor rotation fails, call Service
Engineer
Controller D1 SRAM 1. Interface 1. Switch OFF the No
Pressure Memory Board (CPU). Analyzer and Switch it
Error on after few minutes.
G1 Low 1. 2. Check the pressure
Pressure Malfunctioning unit for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
Pressure G2 High 1. Check the pressure unit No
Pressure Malfunctioning for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
Reagent H1 RGT! RGT 1. Reagent 1. Check the placement No
Tray Cover tray cover of Reagent Cover
Open placement
2. The logic 2. Check the logic levels
levels at the at the baseboard
baseboard connectors/connector
connectors connections and verify
for proper functionality.

3. Connector
connections

XL-200
Error Handling 8-45

Dome H2 Dome Dome is open Close the dome No


open Level 1 properly
Level 1
Dome H3 Dome Dome is open Close the dome and No
and RGT open Level 1 RGT cover properly
cover Level 1 and RGT
and RGT cover is open
cover
open.
Dome H4 Dome Dome is open Close the dome No
open Level 2 properly.
Level 2
Check the opto
Dome H5 Dome Dome is open Close the dome and No
and RGT open Level 2 RGT cover properly.
cover Level 2 and RGT
and RGT cover is open Check the opto.
cover
open.
Dome H6 Dome Dome cover is Close the dome cover No
open open open Level 2 properly
Level 1
and Level
2
Dome H7 Dome Dome cover is Close the dome cover No
and RGT open open Level 1 and RGT cover properly
cover Level 2 and Level 2
and Dome and RGT
open cover is open
Level 1
and RGT
cover
open
Cleaning I1 -- Low 1. Cleaning 1. Check the Cleaning No
Can Cleaning solution Level solution Level
Solution
Level 2. Sensor 2. Check the Sensor
output of Level Output of Level Sensor
Sensors
Waste J1 -- Empty 1. Waste 1. Check the Waste No
Can Waste Level Level
Reservoir/
2. Sensor 2. Check the Sensor
Waste
output of Level Output of Level Sensor
Tank full
Sensors
to
Capacity
Bio- K1 -- Bio- 1. Bio-Waste 1. Check the Bio-Waste No
Waste Waste Level Level
Can Tank Full
to 2. Sensor 2. Check the Sensor
Capacity output of Level Output of Level Sensor
Sensors

XL-200
8-46 Error Handling

Pressure L1 -- Low DI 1. Check the pressure unit No


Water Malfunctioning for any leakage or
Level of pressure blockage in the tubing
unit
2. Leakage/
Blockage in
pressure
tubing
DI Water M1 -- DI Water 1. DI Water 1. Check the DI Water No
Can Tank Level Level
Level less
2. Sensor 2. Check the Sensor No
than or
output of Level Output of Level Sensor
equal to
Sensors
50%
Photomet N1 -- PDC 1. PDC Card. 1. Goto Service Check No
er Operation and give Emergency
al ERROR Stop Command.
2. Interface 2. Switch OFF the
Board and its Analyzer and Switch it
connector. on after few minutes.
Photomet N2 -- PDC 1. PDC Card. 1. Goto Service Check No
er Communi and give Emergency
cation Stop Command.
ERROR
2. Interface 2. Switch OFF the
Board and its Analyzer and Switch it
connector. on after few minutes.
Barcode P1 -- Reagent 1. Reagent 1. Check the Reagent No
Scanner Barcode Barcode barcode scanner
Scanner Scanner
Failure
2. Reagent 2. Check the Reagent
barcode barcode scanner
scanner connections
connections
3. Interface
board and its
connections
Barcode Q1 -- Sample 1. Sample 1. Check the Sample No
Scanner Barcode Barcode barcode scanner
Scanner Scanner
Failure
2. Sample 2. Check the Sample
barcode barcode scanner
scanner connections
connections
3. Interface
board and its
connections
Reagent R1 RGT!! RGT 1. Reagent 1. Check the placement No
Tray Cover tray cover of Reagent Cover
open for 5 placement
minutes

XL-200
Error Handling 8-47

under 2. The logic 2. Check the logic levels


standby levels at the at the baseboard
baseboard connectors/connector
connectors connections and verify
for proper functionality.

3. Connector
connections

Reaction T9 @TM RCT 1. RCT heater 1. Go to [Service Check: No


Tray P Temperat and its RCT Temp]; Give
ure out of connections <Read> command. RCT
range temperature should be
displayed along with the
RCT sensor status
2. Interface 2. If the temperature is
board and its not coming within range,
connections call Service Engineer
3. RCT
sensors and
its
connections
Reaction DC DC* Reaction 1. Cuvettes Retest the result. No
Tray of an on- dirty
board
diluted
sample is
performed
in Dirty
Cuvette
Dome DM Close Dome is open Close the dome No
Dome to properly.
Proceed

XL-200
Part

IX
Configuration 9-2

9 Configuration
This section describes step-by-step procedures for some common configuration tasks. You must
have the required user access level to perform these tasks.

See the following section for more details:

Login and password recovery

Setting UI language

Setting test sequence

Access control

Setting connection with host computer

Entering the master details

Create profile

9.1 Login and password recovery


This section describes the procedure to recover the password for the user login User, in case you
lose or forget the password. However, the password for other user login can be reset by the
administrator for their login from the Settings > User Rights screen.

For more information on setting the user access see section User Rights.

Follow this procedure for recovering login password:

1. In the login screen, enter User in the Login ID text box and click on the link “Click Here” as
shown in figure below.

On clicking, a text file is created which contains password details of the user and sends to
the location C:\MultiXLLOG. The following screen will be displayed.

XL-200
9-3 Configuration

2. Go to folder C:\MultiXLLOG, and send the generated text file, for example
‘ForgotPWD20190813.Txt’ to the service engineer.

3. Click OK to close.

9.2 Setting UI language


The user interface language can be changed according to your choice from the available list of
languages. MultiXL application uses this language in dialog boxes, menus, captions, header in the
screen, and other items in the user interface.

List of Languages supported: English, Chinese, Italian, Spanish, Portuguese, Russian, French,
German, Polish and Czech.

To change the language, do the following:

1. Click on the Settings from the main menu.

2. Go to System Parameters screen, and click on the three dotted button available on the
Default Language parameter.

4. Select the desired language from the Set Language drop down list.

5. Click OK. The captions on the screen will appear in the selected language. Alternatively,
language can also be changed using F10 key from the keyboard.

6. Click on Save to save the settings.

9.3 Setting test sequence


See the following procedure to set the display sequence:

1. Go to Settings in the main menu.

XL-200
Configuration 9-4

2. Select Test Sequence screen.

3. Select the appropriate tests sequence option.

4. Rearrange the tests as required using the buttons provided for sorting.

5. After making changes, click on Save.

Once the test display sequence is set, the tests will appear in the specified sequence.

The display sequence of tests will be changed and displayed in the following screen.

Patient Entry

Reports

Search

Test Parameter > Test Details

Test Parameter > Test Volumes

Test Parameter > Reference Ranges

Profiles/Calc > Profiles

QC Calibration > Calibration

9.4 Access control


Administrator of the system can create new user and provide access control through the User Right
screen.

Refer section User Right for more details.

See the following sections in more details:

To create new user login

To provide access rights to existing user

To change the user ID password

9.4.1 To create new user login


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the CLEAR button, and then enter the user name in the User Name field.

4. Lab-Admin and Lab-User(s) Login with their respective Menu Access are present by default

5. Now enter the type of user using User Type drop down list. Following options are available:

User
Analyst

XL-200
9-5 Configuration

Doctor

A user defined with User Type as Analyst or Doctor will also appear in the list of
Analyst and Doctor respectively from Patient Entry screen.

5. Enter the following fields:

On Panel
Address
City
State
Country
Zip Code
Telephone
Email ID
Login ID
New Password
Confirm Password

User must enter the details for the parameters that are marked with red asterisk.

6. Once all the data are entered, click on the SAVE button. This will create the user ID.

7. User can use this user ID for system login.

9.4.2 To provide access rights to existing user


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the search button. On clicking, the HELP window will be displayed containing
the list of existing user IDs.

4. Now, select the required user name by double click and click EDIT button.

XL-200
Configuration 9-6

5. Check or uncheck the check boxes under column Full Access as per requirement, and click
SAVE to confirm. The settings will be saved for that user id.

User must replace the old password with the new password before saving the
settings.

XL-200
9-7 Configuration

9.4.3 To change the user ID password


1. Click on Settings from the main menu.

2. Select User Right screen.

3. Click on the search button. On clicking, the HELP window will be displayed containing
the list of existing user IDs.

4. Now, select the name of the user by double click and click EDIT button.

5. Now enter the old password, new password, and confirm password and then click SAVE to
confirm the settings.

6. If the user has forgotten the password, click on EDIT, select the RESET PASSWORD check
box and then enter the New Password and Confirm Password. The Reset Password is not be
available for Lab-User Login.

9.5 Connection to Host PC


This section explain you how to establish a connection between analyzer's Data Station and Host
PC in LAN (Local Area Network) and Peer-to-peer network.

Refer section Host Settings for more details.

See the following sections in more details:

In peer to peer network (using serial port)

In LAN (Local Area Network)

XL-200
Configuration 9-8

9.5.1 In peer to peer network

Follow the procedure to connect with host:

1. Click on Settings from the main menu.

2. Select Host Settings screen.

3. Click EDIT.

4. Select option RS 232C, and enter the following parameters.

Port No.

Baud Rate

Parity

Data Length

Stop Bits

Make sure that baud rate, parity, data length and start bit settings entered in the
host computer should match with analyzer's PC.

5. After entering the details, click CONNECT AND SAVE.

On successful connection, connection between the LIS and host will be established, and
data will be saved.

Use CHECK CONNECTION to check the communication.

XL-200
9-9 Configuration

9.5.2 In LAN (Local Area Network)

Follow the procedure to connect with host:

1. Click on Settings from the main menu.

2. Select Host Settings screen.

3. Select option TCP/IP, and enter the following parameters.

IP Address

Port No.

Make sure that the port number entered in the host computer should match with
analyzer's PC.

4. After entering the details, click CONNECT AND SAVE.

On successful connection, connection between the LIS and host will be established, and
data will be saved.

Use CHECK CONNECTION to check the communication.

9.6 Entering the master details


This section explains you how to enter master details through Master screen. Details entered here
will be displayed on the various screen.

The master patient database stores information like:

XL-200
Configuration 9-10

Area from which the samples are collected

Name of referring doctor

Name of analyst

Name of laboratory

Name of manufacturer

Minimum and maximum reference range

Types of unit

Calculation formula

Instrument

See section Master for more details.

9.6.1 Add area


To add area name

1. Click Master from main menu.

2. Select Area screen.

3. Enter the area name.

4. Click on SAVE.

5. This will add the area name and displayed in the grid.

To edit area name

1. Click Master from main menu.

2. Select Area screen.

3. Select the area name to be updated.

4. Click on EDIT.

5. Change the area name.

6. Click on SAVE.

To delete area name

1. Click Master from main menu.

2. Select Area screen.

3. Select the area name to be updated.

4. Click on DELETE.

XL-200
9-11 Configuration

5. Change the area name.

6. Click on SAVE.

9.6.2 Add doctor


To add doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Enter the name of doctor and its demographics.

4. Click on SAVE.

5. This will add the doctor name and displayed in the grid.

To edit doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Select the name of doctor to be updated.

4. Click on EDIT.

5. Edit the name or other details.

6. Click SAVE .

7. This will update the doctor's name and displayed in the grid.

To delete doctor name

1. Click Master from main menu.

2. Select Doctor screen.

3. Select the name of the doctor to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.3 Add analyst


To add analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Enter the name of analyst and its demographics.

4. Click SAVE.

XL-200
Configuration 9-12

5. This will add the analyst name and displayed in the grid.

To edit analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Select the name of analyst to be updated.

4. Click EDIT.

5. Edit the name or other details.

6. Click SAVE .

7. This will update the analyst's name and displayed in the grid.

To delete analyst name

1. Click Master from main menu.

2. Select Analyst screen.

3. Select the name of the analyst to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.4 Add laboratory


To add laboratory name

1. Click Master from main menu.

2. Select Laboratory screen.

3. Enter the name of laboratory and its demographics.

4. Click SAVE.

5. This will add the laboratory name and displayed in the grid.

To edit laboratory name

1. Click Master from main menu.

2. Select Laboratory screen.

3. Select the name of laboratory to be updated.

4. Click EDIT.

5. Edit the name or other details.

6. Click SAVE .

XL-200
9-13 Configuration

To delete laboratory name

1. Click Master from main menu.

2. Select Laboratory screen.

3. Select the name of the laboratory to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.5 Add manufacturer


To add manufacturer name

1. Click Master from main menu.

2. Select Mfg screen.

3. Enter the name of manufacturer.

4. Click SAVE.

5. This will add the name and displayed in the grid.

To edit manufacturer name

1. Click Master from main menu.

2. Select Mfg screen.

3. Select the name of manufacturer to be updated.

4. Click EDIT.

5. Edit the name.

6. Click SAVE .

7. This will update the manufacturer's name and displayed in the grid.

To delete manufacturer name

1. Click Master from main menu.

2. Select Mfg screen.

3. Select the name of the manufacturer to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

XL-200
Configuration 9-14

9.6.6 Add reference range


To add reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Enter the min and max reference range.

4. Click SAVE.

5. This will add the name and displayed in the grid.

To edit reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Select the reference range to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the reference range and displayed in the grid.

To delete reference range

1. Click Master from main menu.

2. Select Reference Range screen.

3. Select the name of the reference range to be deleted.

4. Click DELETE.

5. This will delete the name from the grid.

9.6.7 Add unit


To add a unit

1. Click Master from main menu.

2. Select Unit screen.

3. Enter the unit.

4. Click SAVE.

5. This will add the unit and displayed in the grid.

To edit a unit

1. Click Master from main menu.

XL-200
9-15 Configuration

2. Select Unit screen.

3. Select the unit to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the unit and displayed in the grid.

To delete a unit

1. Click Master from main menu.

2. Select Unit screen.

3. Select the unit to be deleted.

4. Click DELETE.

5. This will delete the unit from the grid.

9.6.8 Add calculation formula


To add a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Enter the calculation formula.

4. Click SAVE.

5. This will add the calculation formula and displayed in the grid.

To edit a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Select the calculation formula to be updated.

4. Click EDIT to modify.

5. Click SAVE .

6. This will update the calculation formula and displayed in the grid.

To delete a formula

1. Click Master from main menu.

2. Select Calculation Formula screen.

3. Select the calculation formula to be deleted.

XL-200
Configuration 9-16

4. Click DELETE.

5. This will delete the calculation formula from the grid.

9.6.9 Add instrument


To add instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Enter the name of instrument.

4. Click SAVE.

5. This will add the instrument name and displayed in the grid.

To edit instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Select the name of instrument to be updated.

4. Click EDIT.

5. Edit the name.

6. Click SAVE .

7. This will update the instrument's name and displayed in the grid.

To delete instrument name

1. Click Master from main menu.

2. Select Instrument screen.

3. Select the name of the instrument to be deleted.

4. Click DELETE.

5. This will delete the instrument's name from the grid.

9.7 Archive Data


The archive data is the process of moving patient results to separate data storage for long-term use
Data archives consist of older patient data which can be used for future reference, if required.

Data archiving improves the performance of (Live) database with the following key benefits.

Faster search of patient results

Quick accessibility of patient results

Reduces the amount of storage required for patient results.

XL-200
9-17 Configuration

For archiving and restoring patient data, the Archive option will appear on the Maintenance menu as
shown in the following:

Initially, when the software is installed, this option is not visible. It appears only when the patient
results reaches to a specific limit. In this case, at specific time interval, software automatically
prompts the user to archive the data when it is necessary. Thereafter, this option will be always
visible.
It is advisable to archive the older patient results to separate data storage.

It is mandatory to archive the data before starting the batch run when the patient
result reaches a specific limit (software shows alert message, as required).

Only Patient results will be archived. The Calibration, Control and Consumables
data will always remain in the (Live) Database. While archiving the patient
results, the required additional information such as Area, Location, Doctor,
Reference Range etc are copied to the separate data storage (Archive Database)
and available while reviewing archived results.

This section includes:

Archiving Data.

Viewing Archived Data

XL-200
Configuration 9-18

Observations

9.8 Create profile


This section explain you how to create and delete the profile.

See the following section in more details:

Add profile

Delete profile

9.8.1 Add profile


The profile can be created from the Profiles screen.

The procedure is given below:

1. Open Profiles/Calc screen.

2. Enter the profile name and profile report name in the respective text box.

3. Add the required tests by clicking on the test name from the Tests grid.

4. Click on SAVE to save the profile.

5. Once the profile is saved, the name appears in the Profiles grid.

9.8.2 Delete profile


Use the following instructions to delete the profile:

1. Open Profiles/Calc screen.

2. Select the profile name from the Profile grid.

3. Click Delete.

4. Click Yes.

XL-200
Part

X
Result Flags 10-2

10 Result Flags
Measurement result flags are printed out together with the measurement result. See the section Flag
List in more details.

10.1 Flag List


Serial Flags Cause
No.
1 # This flag is issued to indicate that the result is obtained from an auto-rerun.
This flag is issued for all rerun results.
2 F This flag is used to indicate that correlation correction has been used to
calculate and declare the final result. That is, this flag is issued when in the
equation Y = aX + b, a is not 1 and/or b is not zero.
3 -1SD This flag is issued with control results when the result is below 1SD limit.
4 +1SD This flag is issued with control results when the result is above 1SD limit.
5 -2SD This flag is issued with control results when the result is below 2SD limit.
6 +2SD This flag is issued with control results when the result is above 2SD limit.
7 -3SD This flag is issued with control results when the result is below 3SD limit.
8 +3SD This flag is issued with control results when the result is above 3SD limit.
9 ?SD This flag is issued with control results when the target Mean and SD values
have not been defined for the control in Consumables screen. Therefore,
flags such as “±1SD”, “±2SD”, “±3SD” cannot be given.
10 CALC! Calculated Item is not calculated for any of the following reasons.
1. Denominator is 0 (zero) in the process of calculation for compensation.
2. Test result to be used for Calculated Item has not been measured yet.
3. Any test to be used for Calculated Item has data/calibration alarms, such
as NOCAL.
4. Any test to be used for Calculated Item errors (S*, R1* etc.)
11 NOCAL This flag is issued with patient or control result and indicates that the
calibration table is not available for result calculation. The calibration table
needs to be checked and corrected to calculate a result (e.g. calibration is
not present or number of standards provided for calibration is less than
required.
12 MONO This flag is issued with patient and control results when, for the concerned
test, the absorbance’s of the calibrators are not changing monotonically
with their respective concentration in the calibration table.
13 V-D This flag is issued with patient results and indicates a Decreased volume
run.
14 V-I This flag is issued with patient results and indicates Increased volume run.
15 PD This flag is issued with patient and control results to indicate that the
sample was pre-diluted.
16 P* This flag is issued with patient and control serum results to indicate that
prozone (antigen excess) has occurred.
17 TEC-H Upper technical limit violated. Measured value or absorbance slope is higher
than the set maximum technical limit. (Set Maximum limit to zero to cancel
the check for TEC-H flag.)

XL-200
10-3 Result Flags

18 TEC-L Lower technical limit violated. Measured value or absorbance slope is lower
than the set minimum technical limit. (Set Minimum limit to zero to cancel
the check for TEC-L flag.)
19 RANGH 1. This flag is issued with patient and control results to indicate that the
absorbance of the sample is higher than the absorbance of the highest
concentration calibrator in the calibration table for an increasing reaction
direction test.
2. This flag is also issued with patient and control results if the absorbance
of the sample is lower than the absorbance of the highest concentration
calibrator in the calibration table for a decreasing reaction direction test.
20 RANGL 1. This flag is issued with patient and control results to indicate that the
absorbance of the sample is lower than the absorbance of the blank (or
lowest concentration calibrator) in the calibration table for an increasing
reaction direction test.
2. This flag is also issued with patient and control results if the absorbance
of the sample is higher than the absorbance of the blank (or lowest
concentration calibrator) in the calibration table for a decreasing reaction
direction test.
21 EVH This flag is issued with the patient result when the result is higher than the
concentration of the highest calibrator and is calculated by extra-polating
the calibration curve on higher side.
Extrapolation % (maximum 20%) is set in system parameters.
22 EVL This flag is issued with the patient result when the result is lower than the
concentration of the lowest calibrator and is calculated by extra-polating the
calibration curve, upto zero.
Extrapolation % (maximum 20%) is set in system parameters.
23 H Measured value is larger than upper limit set for normal value range for the
corresponding age, sample type and category.
24 L Measured value is smaller than lower limit set for normal value range for the
corresponding age, sample type and category.
25 PANH High Panic value alarm. This flag is issued with a sample result to indicate
that the patient result is higher than the Upper Panic Limit programmed in
Test Parameter for the corresponding age, sample type and category.
26 PANL Low Panic value alarm. This flag is issued with a sample result to indicate
that the patient result is lower than the Lower Panic Limit programmed in
Test Parameter for the corresponding age, sample type and category.
27 LINxx Linearity abnormal (checked only for Rate A and Rate B assays). When
the reaction during measurement points M2S and M2E is non-linear beyond
the set limit for linearity of reaction, this flag is given. The percent linearity of
reaction is indicated by a two digit number xx after “LIN”.
28 Lim0 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there is no measurement point available for result calculation,
then this flag is issued and result will be “NA”.
29 Lim1 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there is only one measurement point available for result
calculation, then this flag is issued and result will be “NA”.
30 Lim2 This flag is applicable for Rate Chemistries, only during the extension logic
(Technical Limit is zero) and when Reaction Absorbance Limit is present
(non-zero). If there are only 2 measurement points available for result

XL-200
Result Flags 10-4

calculation, then this flag is issued.


31 ~ When Linearity Extension Logic method is used to reduce the
measurement range to match absorbance range setting, this flag should be
given. (Technical Limit is zero, Reaction Absorbance Limit is non-zero.
More than 2 measurement points are available for result calculation)
32 AbsLim This flag is issued for End-Point chemistries and Rate chemistries when the
absorbance is beyond the Reaction Absorbance Limit set in Test
Parameter.
For Rate-chemistries, this flag will be issued when Technical limit is set. In
this case, Extension Logic will not be applied.
33 RgtAbsMin This flag indicates that the reagent 1 absorbance is lower than the
programmed Reagent Absorbance Minimum.
34 RgtAbsMax This flag indicates that the reagent 1 absorbance is greater than the
programmed Reagent Absorbance Maximum.
35 ??? This flag is issued when the denominator becomes zero during calculation
or an overflow error occurs in logarithmic or exponential calculation.
36 @TMP This flag is issued to photometric results when the RCT temperature was
out of range while the measurement was in process. Flag is not applicable
to ISE results.
37 TO This flag indicates Time Out received from the analyzer, instead of the
result.
38 Cal* This flag is issued with patient and control results to indicate that the
results are being calibrated with previous calibration data.
39 CAL** This flag is issued with patient and control results to indicate that the test is
performed with Un-Calibrated Reagent.
This Flag is issued when 'Issue Cal** flag when appropriate Lot/Bottle
Calibration is not available' option is ticked in Settings > Calibration Policy
Settings
40 R1? /R2? This flag is issued with the results when test is performed with the over-filled
reagent volume during run. In this condition, the result will be declared with
NA.
41 D? This flag is issued with the result when the test is performed with overfilled
Diluent or Urine ISE Diluent volume during run. In this condition, the result
will be declared with NA.
42 COMM* This flag is issued with the results in the following cases:
Absorbance of Reading Area (M1S-M1E, M2S-M2E) is lost
Absorbance after Reagent 1 addition is lost
Absorbance after Reagent 2 addition is lost for 2-Reagent chemistry.
In this condition, the results will be declared with NA.
43 W* During carry over pair process, if the Detergent Wash/Reagent Wash
solution is not found on Reagent Tray, VOD error or any other error is
occurred (during wash operation), then this flag is issued with the result.
44 RD This flag is issued with the results when test is performed from discarded
reagent bottles, during run. In this condition, the result will be declared with
NA.
45 N! This flag is issued to patient results having a negative value. Negative
results can be sent to host and also for a re-run based on user selection. If
"Print Negative Result" check-box is unchecked in System Parameters,
then in this condition, negative test result will be printed as zero in Patient

XL-200
10-5 Result Flags

Report and N! Flag will be printed only if “Hide Flags” option is not selected
during printing.
46 HV! This flag is issued when, during RUN the measured volume in the reagent
bottle is more than the specific capacity of that particular bottle type (small/
large).

NOTE: This flag is issued only for fresh/new reagent bottles.

47 LV! This flag is issued when, during RUN the measured volume in the fresh or
used reagent bottle is below the tolerance of last known level.

48 DA This flag is issued when, test affected due to dome opened abruptly (level 2)
and ARM movement is stopped.

49 ABS! This flag is issued when an Absorbance in a Reaction curve is above 3.0,

In entire reaction curve, this flag is issued in following condition:

o Primary ABS > 3.0 or

o Secondary ABS > 3.0 or

o For a chemistry with dual-wavelength, (Primary ABS – Secondary ABS) >


3.0

In this condition result will be declared with NA.

50 CD This flag indicates that clot has been detected during sampling for that test.
In this condition result will be declared as “NA” .

XL-200
Part

XI
11-2 Maintenance

11 Maintenance
This section provides the necessary and minimal maintenance procedures in order to ensure that the
analyzer operates correctly and provides the accurate measurement results.

The analyzer has been designed to require very little user maintenance compared to the other
analyzers of the same class. Regular cleaning and periodic maintenance as per the schedule keeps
the analyzer in good working condition without any trouble.

Change the reagent bottles from time to time before adding the fresh reagent. It
is recommended to check and maintain a stock of spares and consumables.

To do this, see the following maintenance procedure:

Daily Maintenance

Weekly Maintenance

Quarterly Maintenance

Annual Maintenance

Preventative Maintenance

11.1 Daily Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

The inside of the Sample Tray and Reagent Tray are exposed to splashes of
samples / reagents, contact with ambient room air and condensation on the
walls. This gives rise to bacterial and fungal growth in these parts of the
analyzer. To avoid such conditions, clean the inside of the trays thoroughly on
a regular basis or when a spill occurs.

Start of the day procedure


Serial Number Description
1 Fill the DI water can.
2 Fill the cleaning solution can.
3 Clean the probes tips and stirrer paddle with tissue paper soaked in alcohol.
4 Perform the sample and reagent probe wash.
5 Replace the printer paper if necessary.

XL-200
Maintenance 11-3

6 Perform Prime, Cuvette Wash and Probe Wash operations & Check Cell
Blanks.
7 Perform the photometer check and verify that the auto span check has passed
successfully. (Observe after 30 minutes warm-up).
8 Verify the reagent tray and reaction tray temperature.
9 Remove any condensation present on the walls of the reagent tray, near the
reagent bottle necks or on the barcode label using a dry tissue.
10 Replenish or replace the reagents if necessary.
End of the day Procedure
Serial Number Description
1 Remove and discard all sample / standard and controls cups or tubes from the
sample tray.
2 Carry out Acid and Alkali Wash (Auto Wash) if Latex based chemistries are
used during the day.
3 Perform Water save.
4 Take a backup of all patient reports.
5 Turn off the main switch located on the left side of the analyzer (in case ISE
and if reagent cooling required, leave switch on).
6 Remove any condensation present on the walls of the reagent tray or near the
reagent bottle necks using a dry tissue.
7 Empty the Waste and Bio-hazardous waste cans.
8 Clean analyzer external surface to remove residues of serum, reagents etc.

11.2 Weekly Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Serial Number Description


1 Clean and fill the DI water can.
2 Clean the Cleaning solution can.
3 Clean the stirrer paddles and laundry probes with alcohol.
4 Check the syringe assembly and surrounding tubes.
5 Clean the computer, trolley, monitor, keyboard and printer external
surface.
6 Clean the area around the analyzer, and discard any unwanted item.

XL-200
11-4 Maintenance

(Maintain proper room cleanliness).


7 Clean the sample or reagent probe.
8 Clean the Sample tray.
9 Clean the Reagent tray
10 Perform an auto span check and note down the gain values for all the
wavelengths.
11 Perform a cuvette rinse and check cuvette blanks
12 Perform a precision check and note down the %CV for an end point and
kinetic test.
13 Clean the barcode reader window in the piece of RGT base unit

11.3 Quarterly Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols.

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Serial Number Description


1 Clean and fill the DI water can.
2 Clean the Cleaning solution can.
3 Clean the stirrer paddles and laundry probes with alcohol.
4 Check the syringe assembly and surrounding tubes.
5 Clean the computer, trolley, monitor, keyboard and printer external surface.
6 Clean the area around the analyzer, and discard any unwanted item.
(Maintain proper room cleanliness).
7 Clean the Waste hub.
8 Clean the sample or reagent probe.
9 Clean the Sample tray.
10 Clean the Reagent tray
11 Perform an auto span check and note down the gain values for all the
wavelengths.
12 Perform a cuvette rinse and check cuvette blanks
13 Perform a precision check and note down the %CV for an end point and
kinetic test.
14 Clean the barcode reader window in the piece of RGT base unit

XL-200
Maintenance 11-5

11.4 Annual Maintenance


The bio-hazardous waste is highly infectious. Drain the bio-hazardous waste
from the Waste Can by strictly following the waste disposable laboratory
protocols.

Always use fresh DI water in clean and pre-washed Cans to prevent water from
contamination.

Average life of the Lamp is 1000 hours. Replacement of Lamp depends on its
usage and ON Time.

Serial Number Description


1 Clean the Waste can.
2 Clean the Bio hazardous waste can.
3 Clean and fill the DI water can.
4 Clean the cleaning solution can.
5 Replace External Tubing to the Waste, Bio Hazardous Waste, Cleaning
Solution And DI Water Cans.
6 Clean the Analyzer External Surface.
8 Clean the computer, monitor, keyboard and printer external surface.
7 Clean the area around the analyzer, and discard any unwanted item
(maintain proper room cleanliness).
8 Check and replace the sample probe if necessary.
9 Check and replace the stirrer paddle.
10 Replace the laundry probes.
11 Clean the Sample tray.
12 Clean the Reagent tray.
13 Check and replace the syringe dilutor assembly.
14 Clean the fans.
15 Clean the bar code readers.
16 Perform the auto span check and note down the gain values for all the
wavelengths.
17 Perform a cuvette rinse.
18 Perform a precision check and note down the %CV for an end point and
kinetic test.

XL-200
11-6 Maintenance

19 Replace the lamp.


20 Clean the internal surface free of dust.
21 Perform an auto span check and note down the gain values for all the
wavelengths.
22 Carry out site verification for temperature, line voltage, electrical ground,
ventilation, external interferences, room lighting, and laboratory cleanliness
practice. Refer section 3.4 Site Requirement for more details.
23 Make a detailed entry in the error log book, of the maintenance carried out
and site verifications.

Average life of water filter is 3 months. Replacement of water filter depends on quality of DI water
used.

DI water pump has average life of around 4000 hrs. Depending on the use of the analyzer, DI water
pump may need periodic replacement.

11.5 Replacement Schedule for Spares and Consumable

Spares/
Serial Number 3 Months 6 Months 9 Months 12 Months
Consumables

1 SAMPLE PROBE

2 STIRRER PADDLE

3 CUVETTE DRYER
BLOCK (TEFLON)

4 LAUNDRY
DISPENSE TUBING

5 LAUNDRY
ASPIRATION
TUBING

6 LAUNDRY PROBE
ASSY

7 PHOTOMETER
LAMP ASSY

11.6 Preventative Maintenance


This section tell you the necessary preventive maintenance for the analyzer.

When any abnormal conditions are found in the analyzer, the operator is requested to check the
following items:

1. Preparation and preservation methods of reagents.

2. Preparation and preservation methods of sample.

3. Operational procedures of the analyzer and maintenance work.

When such an abnormal condition is considered to be caused by an electrical or

XL-200
Maintenance 11-7

mechanical failure, do not try to carry out the inspection of the analyzer by your
own and call for service at our customer service department.

Malfunction at the Time of Operation

Anomalous Measurement Results

High Resultant Values from a Specific Method for all Samples

Low Resultant Values from a Specific Method for all Samples

Randomly Derived Erroneous Measurement Results

Anomalous Resultant Values from all Methods for a Sample

Check for Preparation of Reagent, Calibrator or QC Sample

11.6.1 Information Requested by Our Customer Service Department


When any technical service will be called for at our customer service department, the following
information is requested to be prepared.

Trouble in assay.

Serial number of analyzer in use.

Method code in question.

Explanation of encountered trouble.

Serial number and lot number of reagent, calibrator and QC sample in use.

A few calibration results that were carried out recently.

A few measurement results of QC sample, that were carried out recently.

Measurement results.

Trouble in analyzer.

Serial number of analyzer in use.

Software version numbers in use (PC, Operating System, Sub-CPU).

Explanation of the relevant alarm and problem

Other information about the analyzer in use and maintenance.

11.6.2 Malfunction at the Time of Operation


While functioning of the analyzer when it is suddenly deactivated check the following possibilities:

1. Check that the main switch located on the left hand side of the analyzer is at "ON" position.

2. Check that the main fuses are not burnt. When the main fuses are checked, turn the main
switch off without fail and then pull out the plug of power supply cable from its receptacle on
the analyzer. Open up the fuse cover and pull the fuses out.

XL-200
11-8 Maintenance

3. Check that the circuit breaker of the power supply system to which the analyzer is connected
is not cut off.

11.6.3 Anomalous Measurement Results


Analytical results are noticed by error flags or unexpected results. There are following cases in which
trouble shooting of the analyzer is required:

1. Error flag is set to the calibration results.

2. Error flag is set to the measurement results of QC sample or normal sample.

3. The measurement results of QC sample are out of range of judgment criteria. Investigate which
situation shown below is applicable to the error in the measurement results of calibration, QC
sample or normal sample. Based on the investigation, further check may be requested.

4. The resultant values obtained from measurements of a specific method are high for all
samples.

5. The resultant values obtained from measurements of a specific method are low for all samples.

6. Erroneous results are randomly derived from the measurement.

7. Two or more anomalous measurement results are observed.


a) From all methods
b) Or randomly

11.6.4 Check for Preparation of Reagent, Calibrator or QC Sample


Perform the following checks in order to track down the cause for high, low or random resultant
measurement results. When a reagent, calibrator or QC sample is prepared, read the respective
statement of virtues carefully and follow its instruction.

1. Preparation of reagent.
a) Was there any change of the reagent?
b) Is the term of validity of the prepared reagent still valid?
c) Was the reagent prepared according to the correct procedures?
d) Was the reagent prepared using fresh, non-bacteria contaminated and DI water or
appropriate diluent?

2. Preparation of QC sample.
a) Was the volume used for preparation correct?
b) Was the sample preserved as recommended?
c) Is the term of validity of the sample still valid?
d) Was the sample prepared using a pipette calibrated in terms of volume?
e) Is the term of validity of the sample lot still valid?
f) Was the sample prepared using appropriate diluent?

XL-200
Maintenance 11-9

3. Preparation of calibrator.
a) Was there any change of the lot number?
b) Was the calibrator prepared using volume correctly?
c) Was the calibrator preserved as recommended?
d) Is the term of validity of the calibrator still valid?
e) Was the calibrator prepared using a pipette calibrated in terms of volume?
f) Was the calibrator prepared using appropriate diluent?

Further checks are requested to track down the cause referring to the following lists after the above
checks have been completed.

11.6.5 High Resultant Values from a Specific Method for all Samples

Sr. No. Cause Corrective action

1 Incorrect calibration results. Check the preparation of the calibrator.


Check that the calibration settings are correct.
The calibration is performed again if necessary.

2 Too high inside temperature of RCT Check the temperature shown in the Service
unit. Check > Temperature > Read.
Call for service at our customer service
department when the indicated temperature
deviates from the specified value of 37 ± 0.2ºC.

3 Improper preparation of reagent. Check the preparation of the reagent.

4 Improper preparation of calibrator. Check the preparation of the calibrator.

11.6.6 Low Resultant Values from a Specific Method for all Samples

Sr.No. Cause Corrective action

1 Expiration of the term of validity of reagent. See the statement of virtues that comes
together with the reagent kit for its stability.

2 Improper preparation of reagent. Check the preparation of the reagent.

3 Improper preservation of reagent. See the statement of virtues that comes


together with the reagent kit for its proper
preservation method.

4 Too low inside temperature of RCT unit. Check the temperature shown in the Service
Check > Temperature > Read.
Call for service at our customer service
department when the indicated temperature
deviates from the specified value of 37 ±
0.2ºC.

5 Improper preparation of calibrator. Check the preparation of the calibrator.

6 Excessive volume of reagent dispensed. Check if there is any leakage or drip at


junction of reagent sampling system.

XL-200
11-10 Maintenance

11.6.7 Randomly Derived Erroneous Measurement Results

Sr.No. Cause Corrective action

1 Fibrin clots formed on specific sample tube or Clean the SPT nozzle.
sample cup.
2 Insufficient water or solution supply from Check if the tip of water or solution
respective external tank. tube is positioned below the water or
solution level. Call for service at our
customer service department in case
of trouble.
3 Insufficient stirring. Check if the stirrer rotates in the
center of cuvette and at the correct
speed.

11.6.8 Anomalous Resultant Values from all Methods for a Sample

Sr. No. Cause Corrective action

1 Improper preparation of reagent. Prepare newly the reagent referring to the


statement of virtues that comes together with
the reagent kit.

2 Expiration of term of validity, Prepare newly the reagent referring to the


contamination or paleness of reagent. statement of virtues that comes together with
the reagent kit.

XL-200
Producer
Producer of the analyser XL-200:
Erba Lachema s.r.o.
Karásek 1d 621 00 Brno Czech Republic
+420 517 077 111
www.erbamannheim.com
[email protected]

Instrument or service complaint:


https://www.erbalachema.com/service/en/instrument-complaint/

Erba Lachema is a part of the global Erba Mannheim GmbH Group.

In case of technical problems, contact our service:


[email protected]

Any serious incident that has occurred in relation to the device shall be reported
to the manufactured and the competent authority of the Member State in which
the used and / or patient is established.
Erba Lachema s.r.o.
Karásek 2219/1d, 621 00 Brno, Czech Republic
Tel.: +420 517 077 111, fax: +420 517 077 077
E-mail: [email protected]
www.erbamannheim.com

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