URIT-8021A Operating Manual

Catalogue
COPYRIGHT AND DECLARATION .......................................................................................... 1
PREFACE ................................................................................................................................... 3

CHAPTER 1 SAFETY GUIDELINES......................................................................................... 4

1.1 Safety Cautions ........................................................................................................... 4

1.2 Using Precaution ......................................................................................................... 7
1.3 Installation ................................................................................................................... 9
1.3.1 Instrument Inspection .......................................................................................... 9
1.3.2 Installation............................................................................................................ 9
1.3.3 Environmental Requirements ............................................................................ 10
1.3.4 Location Requirements...................................................................................... 10
1.3.5 Power Requirements .......................................................................................... 11
1.3.6 Instrument Connection ....................................................................................... 11

CHAPTER 2 INSTRUMENT INTRODUCTION ....................................................................... 13

2.1 Brief Introduction ....................................................................................................... 13

2.2 Intended Use ............................................................................................................. 14
2.3 Main Structure ........................................................................................................... 14
2.3.1 Performance and Composition .......................................................................... 14
2.3.2 Top View ............................................................................................................ 15
2.3.3 Rear View .......................................................................................................... 15
2.3.4 Function of Main Part ........................................................................................ 15
2.4 Function and Specification ........................................................................................ 16
2.5 Technical Parameter ................................................................................................. 18

CHAPTER 3 MEASURING PRINCIPLE.................................................................................. 19

3.1 Principle..................................................................................................................... 19
3.2 Assay Methods .......................................................................................................... 19
3.2.1 Endpoint Assay .................................................................................................. 19
3.2.2 Two-point Assay ................................................................................................ 20
3.2.3 Rate Assay (Kinetic Method) ............................................................................. 21

CHAPTER 4 OPERATION ....................................................................................................... 22

4.1 Operating Step .......................................................................................................... 22

4.1.1 Operating Step .................................................................................................. 22
4.1.2 Start up .............................................................................................................. 23
4.1.3 Create Standard Curve...................................................................................... 23
4.1.4 QC Test .............................................................................................................. 23
4.1.5 Test Patient’s Sample ........................................................................................ 23
4.1.6 Finish ................................................................................................................. 24
4.2 Basic Operation ......................................................................................................... 24
4.2.1 Start up .............................................................................................................. 24
4.2.2 Check Instrument State ..................................................................................... 24
4.2.3 Preparation of Reagent ..................................................................................... 25
4.2.4 Preparation of Sample, Standard Solution and Detergent................................ 25
4.2.5 Registration of Standard and QC ...................................................................... 26

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4.2.6 Routine Sample Registration............................................................................. 26

4.2.7 Analyses ............................................................................................................ 29
4.2.8 STAT Analyses ................................................................................................... 29
4.2.9 End of Analyses ................................................................................................. 30
4.3 Obtain Result............................................................................................................. 31
4.3.1 Registration of Sample Information ................................................................... 31
4.3.2 Modification of Test Result................................................................................. 31
4.4 Query of Analytical Result ......................................................................................... 31
4.5 Analytical Curve Display ........................................................................................... 32
4.6 Database Maintenance ............................................................................................. 32
4.6.1 Database Backup .............................................................................................. 32
4.6.2 Database Restoration ........................................................................................ 32

CHAPTER 5 ADVANCED SETUP ........................................................................................... 33

5.1 System Menu ............................................................................................................ 33

5.2 Chemistry Analyses ................................................................................................... 34
5.2.1 Parameter Setup of Routine Item ...................................................................... 34
5.2.2 Parameter Setup of Special Item ...................................................................... 36
5.2.3 Item Combined Setup ........................................................................................ 36
5.2.4 Chemistry Calculated Item Setup ...................................................................... 37
5.2.5 Sequence Setup of Item Display and Printout .................................................. 37
5.3 Special Analyses ....................................................................................................... 37
5.3.1 Standard and QC Analyses ............................................................................... 37
5.3.2 Reading of A/D Signal ....................................................................................... 37
5.4 Chemistry QC Management ..................................................................................... 37
5.4.1 QC Materials Setup ........................................................................................... 38
5.4.2 QC Result Processing ....................................................................................... 38
5.4.3 Analyses of Chemistry QC Diagram ................................................................. 38
5.5 Systematic Parameter Setup .................................................................................... 39
5.5.1 Hospital Information Setup ................................................................................ 39
5.5.2 Setup of Chart Color .......................................................................................... 40
5.5.3 Setup of Serial Communication Port and User’s Name .................................... 41
CHAPTER 6 QUALITY CONTROL ANALYSES AND CALIBRATION .................................. 42

6.1 General Information .................................................................................................. 42

6.2 Quality Control........................................................................................................... 42
6.2.1 Type of Quality Control Materials ...................................................................... 42
6.2.2 Use and Storage ................................................................................................ 42
6.2.3 Setup of Target Value, SD and Control Limit..................................................... 42
6.2.4 QC Procedures .................................................................................................. 43
6.3 Quality Control Method ............................................................................................. 43
6.3.1 Levey-Jennings Method .................................................................................... 43
6.3.2 Westgard QC Rule ............................................................................................ 43
6.3.3 Reasons of Random Error ................................................................................. 46
6.3.4 Reason of Systematic Error .............................................................................. 46
6.4 How to Deal With Out-of-Control .............................................................................. 47
6.5 Calibration and Procedures ...................................................................................... 47
6.5.1 When to calibrate............................................................................................... 47
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6.5.2 Calibrate Procedures ......................................................................................... 48

CHAPTER 7 MAINTENANCE ................................................................................................. 49
7.1 Analyzer Maintenance............................................................................................... 49
7.1.1 Probe and Stirrer Rinse ..................................................................................... 49
7.1.2 Cuvette Rinse .................................................................................................... 50
7.1.3 Reading of Cuvette Signal ................................................................................. 50
7.2 Maintenance .............................................................................................................. 51
7.2.1 Daily Maintenance ............................................................................................. 51
7.2.2 Weekly Maintenance ......................................................................................... 52
7.2.3 Monthly Maintenance ........................................................................................ 53
7.3 Longtime Disuse Maintenance.................................................................................. 53
7.4 Preventive Maintenance............................................................................................ 53

CHAPTER 8 TROUBLESHOOTING ....................................................................................... 54

8.1 Troubleshooting Guide .............................................................................................. 54

8.2 Obtaining Technical Help .......................................................................................... 55
8.3 Troubleshooting Method ........................................................................................... 55

CHAPTER 9 STORAGE AND TRANSPORTATION ............................................................... 59

9.1 Storage ...................................................................................................................... 59
9.2 Transportation ........................................................................................................... 59

APPENDIX A REPLACEABLE COMPONENT ....................................................................... 60

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 URIT-8021A Operating Manual

COPYRIGHT AND DECLARATION

Copyright: URIT Medical Electronic Co., Ltd.

Thank you very much for your purchase of the URIT-8021A Automatic Chemistry Analyzer.

All contents of this manual are complied with the related laws and regulations of the
People’s Republic of China, as well as the specific conditions of the URIT-8021A
Automatic Chemistry Analyzer. All the updated information is included in this manual
before printing. URIT is fully responsible for the revision and explanation of this manual,
and reserves the right to renovate the relevant contents without separate notice. Some of
the schematic pictures in this manual are for reference, if there is any difference, please
according to the real object.

All the information of this manual is protected by the Copyright Law. No part of this manual
may be reproduced, stored or transmitted in any form, or by any means without the
express written permission of URIT.

All instructions must be followed strictly during operation. In no event should URIT be
responsible for failures, errors and other liabilities resulting from user's noncompliance
with the procedures and precautions described in this manual.

Guarantee of limited quality liability: The Operating Manual of URIT-8021A Automatic

Chemistry Analyzer has been clearly shown the guarantee of quality liability between
URIT and users, rights and duties in the after sale service and starting and ending of the
agreement.

If a malfunction occurred under normal use because of the material and workmanship,
URIT will provide one year’s warranty service from the date of installation to this
instrument which sold by URIT and agents. The using period of this instrument is 10 years.

Once the following situations occurred, URIT assumes no liability to the safety, reliability
and operation condition of the instrument, and all agreed right of free service is deem to be
waived permanently and unconditionally.

 Instrument under improper use or not by maintenance or has been damaged.

 Using the reagents and accessories not supplied or approval by URIT.

 Instrument damage caused by false operation or negligence because of user or

others operates the instrument not comply with this manual.

 Replace accessories not specified by URIT, maintaining, repairing by a personnel

who does not authorized by URIT.

 Components are discounted, drawing and readjusted not approved by URIT.

NOTE
URIT makes no warranties, either express or implied, as to product
quality, performance, and value as a commodity or applicability for any
particular purpose.

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 URIT-8021A Operating Manual

URIT Medical Electronic Co., Ltd.

Add: No.4 East Alley, Jiuhua Road, Guilin, Guangxi 541001, PR China

288586

Fax: +86(773)2288560

Web: www.urit.com

-mail: [email protected]

Supplied by:

URIT Medical Electronic Co., Ltd.

Wellkang Ltd t/a Wellkang Tech Consulting

Suite B, 29 Harley Street, LONDON W1G 9QR, UK

Version: 08/2009-4

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 URIT-8021A Operating Manual

PREFACE
This document is the operating manual for URIT-8021A Automatic Chemistry Analyzer. It
describes the structure, operation, maintenance and troubleshooting concerning the
instrument in details. Users should read carefully the manual and get special training
before operating to guarantee instrument precision, normal operation and personal safety.

Sign Illustration

Meaning of the signs used in URIT-8021A is as following.

Caution. Refer to the

Be careful electric shock
accompanying document

Caution. Hot surface Biohazard

Protective earthing Power on

In vitro diagnostic
Power off
Medical device
Environmental Protection Keep away from heat and
lifetime radioactive source

Serial Number Manufacturer

Recovery May cause personal injury

Refer to operating manual

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 URIT-8021A Operating Manual

CHAPTER 1 SAFETY GUIDELINES

1.1 Safety Cautions

Please comply with the following rules for safety and effective use.

Prevent Breakage and Flammability

Please comply with the following precaution to prevent breakage.

CAUTION
1) Installation should be complied with installed instruction of the manual.

2) If relocation is necessary, contact your local distributor or URIT firstly.

Prevent Electric Shock

Please comply with the following precaution for preventing electric shock.

CAUTION
1) DO NOT move the screws on the cover, such as the screws on the board at
back and side.

2) If a spill occurs or liquid gets into the instrument, please contact URIT.
Neglecting the liquid may cause electric shock.

Prevent Personnel Injury

Please comply with the following precautions for preventing injury.

CAUTION
1) While the instrument is in motion, DO NOT touch the moving parts, such as
sample probe, reagent probe and stirrer, etc. And DO NOT put your finger or
hand into the open part of instrument.
2) Before replacing lamp, turn off the refrigeration switch and wait until the lamp
is cooled down. Otherwise, you may get burned.

Eyes Protection
Please comply with the following precaution for eyes protection.

CAUTION
DO NOT directly look at the light source when the instrument is in motion.

Precision and Accuracy of Data

Please attention the following matters for getting the accurate data.

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CAUTION
1) DO NOT open the top cover, rear cover and reagent tray when the
instrument is under analyzing condition.

2) Please check the accuracy of instrument by quality-control before using.

3) Please comply with the manual to maintain, check and replace the assembly
unit.

4) Please comply with the corresponding explanation to handle the reagent,

quality-control materials and reference materials.
5) Please handle the sample according to the requirements in the manual.

Chemical and Biological Safety

Please comply with the following matters for chemical and biological prevention.

Biological Hazard
If chemical adheres to the human body, contagion may occur. DO NOT touch the
sample, mixed solution and waste solution directly. Be sure to put on protective
gloves, clothes, or even glasses if necessary. If the sample splashes to the skin
accidentally, please treat immediately according to the working standards and
consult a doctor.

CAUTION
Some reagents are strong acid or alkaline. Please use them carefully avoiding
direct contact. If the reagent spill to the human body, immediately wash it off with
water and soap. If the reagent splashes into eyes accidentally, wash it off with
water and consult an oculist.

Handle Waste Solution

Please comply with the following matters when handle the waste solution in order to avoid
personal injury and protect environment.

Biological Hazard
Some substances contained in QC solution, standard solution and waste
solution are regulated by discharge standards and pollution control regulations,
waste must be disposed according to the relevant environmental protection
regulations.

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Systematic Usage

CAUTION
1) URIT-8021A Automatic Chemistry Analyzer is intended use for medical
institution and laboratory to analyze some specific chemical composition of
human body fluid. If the instrument to be used beyond this scope, consult
URIT firstly.

2) Please consider together with the clinical symptom or other analyzing result
when make the clinical judgment.

Operational Environment

CAUTION
1) Please install the instrument according to the specified installed instruction
in the manual. Otherwise, the results may not reliable even may cause
system damage.
2) Please contact URIT if system state is changed.

Indication for System Use

CAUTION

1) The operator must be trained before operating the instrument. Please follow
the instruction of manual to operate. Improper operation may cause personal
injury, system damage and improper result.
2) Please make a calibration and quality-control test before use the system for
the first time to ensure it can be used normally.
3) A quality-control test must be done when use the system. Otherwise, the
reliability of the result could not be guaranteed.
4) The communication joint of analytical part is set to connect with the
communication joint of operational part. Please use the cables of URIT for
connecting.
5) The operation part is an external computer which is installed the specified
operational software. The computer should be for the instrument exclusive
use. DO NOT run any other software when it is connected with the
instrument. Inappropriate manner may result in computer virus infection
6) Do not touch the keyboard, display or mouse with wet hands or hands with
chemical.

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1.2 Using Precaution

Precaution for Handling Samples

CAUTION
1) URIT-8021A could be used for processing serum, urine and cerebrospinal
fluid sample. Some samples or reagents may not be applicable to
measurements in this instrument. In such case, please consult the reagent
suppliers.

2) Sample must not contain insoluble substances such as fibrin and dust.
Coagulation and impurity may block the sample probe thus causing bad
effect on tests.

3) Anticoagulant and preservative contained in sample may interfere the

accuracy of test results.

4) Take note of the storage condition of sample. Improper storage may

deteriorate sample. For example, the serum sample could be stored for 2
weeks at the temperature of -20℃ , while only 2 hours at 22~24℃. Beyond
expiration, concentration of substances contained in serum will increase or
decrease significantly, especially the enzyme such as ALT and AST.

5) If visible suspended substances exist in urine or cerebrospinal fluid samples,

centrifuge the samples to remove suspended substances before analyses.

6) If pretreatment is needed for samples, or if you want to centrifuge serum

samples, please consult your reagent provider firstly

7) DO NOT expose samples in the air for long because they may be
contaminated or boiled off and thus erroneous test result may occur.

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Handling Reagents, Reference Materials and Control Serum

CAUTION
1) For storage, handling and usage of reagent, or selection of reference
materials and QC material, refer to the Instruction for Use provided by their
manufacturers. Improper storage may not guarantee the accuracy of test
result even though they are not expired.
2) Please consult the reagent supplier about the using instruction of reagent,
standard solution and control serum.

3) The instruction of maintenance of reagent, standard solution and control

materials is signed on the package or enclosure in the manual. Maintenance
by improper way may cause incorrect result even if within its validity.

4) For the stability of reagent in open environments, contact your reagent

supplier.

5) Be sure to perform calibration when replacing reagent. Otherwise, inexact

test result may occur.
6) Set up the reagent parameters provided by reagent manufacturer before
analyses. Only proper reagent setup can guarantee the correct test results.

Cross-contamination among Reagents

CAUTION
Cross-contamination among reagents may influence test results. Contact your
reagent supplier for details. As for how to check cross-contamination among
reagents, contact URIT please.

Precaution in the Analyzing Course

CAUTION
1) If serum is hemolytic, chylific or jaundiced, test results may be influenced.
Please contact your reagent supplier for details.

2) Distilled water should be free of air bubbles.

Caution on Electromagnetic Wave Interference

CAUTION
Keep the instrument away from strong noise source and electromagnetic wave.
Turn off mobile phones and transmitter-receiver when operating the instrument
since the electromagnetic wave may cause an adverse effect on instrument.

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 URIT-8021A Operating Manual

Other Cautions

CAUTION

1) DO NOT touch the keyboard, display or mouse with wet hands or hands with
chemical.

2) Check samples for contamination (dust, or fibrinogen) and air bubble before
analyses.

3) To make periodic maintenance, test and replacing according to the manual

for getting the exact result.

4) For replacements of major parts, such as light source lamp, sample probe,
reaction cuvette, etc., Please contact URIT.

5) For settings of sample volume, reagent volume, wavelength, standard

values, etc., please refer to the instruction in reagent kit as well as this
operating manual. Checking the quality of distilled water and detergent,
check calibration results, control results, and sample results after analyses.
Make sure there is no air bubble in the flow paths.

1.3 Installation

CAUTION
Only the URIT technician can perform the installation of URIT-8021A.

Users shall provide a place satisfying the installation requirements in accordance with this
manual before installation. If relocation is necessary, please contact your local distributor
or URIT.

1.3.1 Instrument Inspection

Please check the carton according to the following procedures:

1) Carefully unpack the package and take out the URIT-8021A Automatic Chemistry
Analyzer and the accessories.

2) Inspect the instrument and accessories for quantity and visible signs of damage
according to the accompanying Packing List.

3) If any loss or damage exists, contact the distributor or manufacturer immediately.

1.3.2 Installation

The instrument is high sophisticated thus proper installation is very important to its
performance. User should guarantee the environment and electrical condition are comply
with the recommended conditions. Provide a distance of 50cm at least for each side for

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operating and maintaining.

1.3.3 Environmental Requirements

Keep away from direct sunlight

Dust free

Installed on horizontal ground

Ground should be able to support 250kg weight because the weight of instrument is 80kg.

Room temperature: 10℃～35℃

Relative Humility: 40％～85％(No condensation)

Atmosphere Pressure: 86kPa～106kPa

The reliability of data could not be guaranteed if the fluctuation of temperature and humility
exceeded the certain range.

Good ventilation and instrument do not face air conditioner directly.

No obvious vibration

Keep away from electromagnetic field and electricity interruption

The instrument should be near to the power.

1.3.4 Location Requirements

The instrument installation layout is below. Surrounding distance is the recommended

maintenance space.

Measurement: cm

Instrument Dimension (including the height of cabinet): 89cm×73cm×112cm (L×W×H)

Dimension of Operating Board (Only for reference):70cm×50cm×80cm (L×W×H)

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1.3.5 Power Requirements

The following power must be prepared; switchboard should be located within 10m.

1) Power
Voltage 230V～, 50/60Hz

2) Grounding
Adapt to local power needs, using three-pin power plug

3) Plug board
A 15A output plug board with more than three 5A sockets. Heavy-duty devices should
not share the plug board with the instrument, such as refrigerator, air conditioner etc.

4) 3 core power cable cat is using; the type of wire and plug is depended on voltage.

CAUTION
Make sure the instrument is grounded properly. Poor grounding may cause bad
effects on test result and even damage to the instrument.

1.3.6 Instrument Connection

1. Take out the power line, one end insert into the power interface of instrument, the
other end connected to the power.

2. Using the communication line which provided by URIT for connection. One end
connects to the COM serial port of computer; the other end connects to the COM
serial port of instrument. And please tighten by the screws.

3. Distilled water and detergent are needed for analyses; meanwhile, the waste solution
will discharge. There are liquid-level inductive interface on the rear of instrument for
connecting to distilled water barrel, detergent barrel and waste barrel. Connect one
end of tube and liquid-level inductive line to the instrument, the other end connect to
the corresponding barrel. The connection of instrument please see figure 1.3.6.

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 URIT-8021A Operating Manual

Figure 1.3.6 Instrument connection

CAUTION
Please connecting the flow path tubes under the instruction of URIT service
engineer or the personnel authorized by URIT.

Note
Do not locate the instrument on a place where difficult to operate cutoff device.

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 URIT-8021A Operating Manual

CHAPTER 2 INSTRUMENT INTRODUCTION

2.1 Brief Introduction

URIT-8021A is a clinical chemistry instrument with the characteristics of open,

full-automatic, discrete/optional, STAT priority and controlled by computer. URIT-8021A is
intended for use in conjunction with reagents to measure quantitatively certain chemical
items in serum, urine and cerebrospinal fluid. Please read the operating manual carefully
before using since it is a high sophisticated instrument.

Work Unit of URIT-8021A consists of optical unit, mechanical operation unit, liquid path
control unit, hardware circuit unit and operating unit.

1) The mechanical operation unit consists of sample processing system, reagent

processing system and eight-probe washing system. The sample processing system
includes one sample tray, one sample probe arm, one sample syringe (the materials
of syringe is ceramic inner core, sampling accurately and free maintenance), and a
sample probe washing pool. Sample tray provides 71 positions, includes 55 routine
sample positions, 8 standard positions, 4 quality control positions and 4 STAT
positions. The routine sample positions for loading sample cup and tube which directly
put into sample tray. Reagent tray supports various specification bottles; The optical
unit consists of 120 cuvettes, high-resolution filter and halogen light, it’s a whole
sealing, statics and spectrophotometry optical system with the special UV intensifier
technology.

2) The operating unit is an external computer (CPU: Intel Pentium4, 2.4GHz or above;
Hard Disk: 120G or above; Memory: 1G or above; Display Resolution: 1024*768 or
above; Peripherals serial port, net mouth, parallel port and USB port), the application
software should be setup under the Windows XP (Home/Professional SP1 ) or the
above operation system.

3) The liquid path control unit consists of vacuum pump, solenoid valve, rinse system
and pipeline system, etc.

4) The instrument is easy to operate. The layout of the screen menu is reasonable,
name is simple. Such as testing parameter setup, patient’s information input,
quality-control, reagent, data query, standard, running test and hardware parameter.
After setting, put the sample and reagent to the instrument and begin to analyzing.
Print out the result by the external printer at last.

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2.2 Intended Use

The instrument is only for professional, in vitro use in hospitals, clinics and laboratories.

CAUTION
Some samples may not be analyzed according to the tested parameter and
reagent. For the case of these samples, please contact reagent manufacturer or
distributor.

2.3 Main Structure

2.3.1 Performance and Composition

The analyzer is mainly consists of analytical unit, computer and external printer (optional).

The analytical unit is composed of reagent tray, sample tray, reaction tray, aspirating
mechanism, stirring mechanism, optical system, liquid path system, hardware circuit.

Customer could select cabinet according to requirement.

Figure 2.3.1 Overview of Analytical Unit

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2.3.2 Top View

Figure 2.3.2 Top View of Analytical Unit

2.3.3 Rear View

Figure 2.3.3 Rear View of Analytical Unit

2.3.4 Function of Main Part

1) Sample Tray: Holds sample cups, and convey the cup to sample aspirating position
for aspirating.

2) Reagent Tray: Holds reagent bottles, and convey the bottle to reagent aspirating
position for aspirating. The reagent tray with 24 hours non-stop refrigeration function,
and the temperature keep in the range of 2-8℃.

3) Reaction Tray: Fixed the cuvette. Sample and reagent reacted in the fixed cuvette in

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37℃ thermostat meanwhile colorimetric directly.

4) Aspirating Mechanism: Aspirates quantitative volume of reagent from bottle and inject
to cuvette; Aspirates quantitative volume of sample from sample cup and inject to
cuvette. The mechanism with the functions of liquid level sensing.

5) Stirring Mechanism: The separate stirring system is designed for stirring the reaction
solution contained in reaction cuvettes.

6) Rinsing Mechanism: Drains out reaction solution and washes the cuvettes, add and
drain out the pure water. The design of eight-step washing can clean the cuvettes
adequately.

2.4 Function and Specification

1) System: Full-automatic, discrete/optional, STAT priority, and with reset function.

2) Stand-by: 24 hours stand-by, auto-sleep and one key startup function.

3) Rinse: Rinsing the inside and outside of aspirating probe (sample probe and reagent
probe) with distilled water, and omni directionally clean the stirrer; washing station of
eight-step rinse the cuvettes with detergent; separate rinse available among items.

4) Sample probe: With liquid level sensing, volume tracking function, auto-protective
function to prevent from collision. The function of probe-clog detected is optional.

5) Reagent probe: With liquid level sensing, volume tracking function, auto-protective
function to prevent from collision. The reagent preheating function is optional.

6) Alarm: Alarm automatically when reagent, sample, distilled water or detergent is

shortage and waste solution is overfull; display reagent allowance and available tests
number in real time; when the absorbance is out of range, the system will alarm.

7) Waste disposal: Two-stage distributaries for high and low concentration waste.

8) Backup reagent position: Three reagent positions available for the same item. When
the first alarm to lack of reagent occurs, aspirating probe will turn to the second
reagent position to aspirate reagent automatically, and the second alarm occurs,
aspirating probe will turn to the third reagent position to aspirate reagent.

9) Reagent capacity expansion: It’s provides the function that a reagent position can be
set to test several items but once only test one item, and four reagents item test.

10) Test method: End point, rate assay(kinetic method), 2-point end point(2-point kinetic
method), dual-wavelength, blank method(reagent blank, sample blank and water
blank), immune turbidimetry, double reagent and electrode, colorimetric, sample
inspection(serum index, such as jaundice, hemolysis and so on ), non-linearity
detection etc.

11) Calibration method: At least linearity (single point, two points or multi points) and
non-linearity calibration. Multiple calibration formula including Logit-Log4P,
Logit-Log5P and exponential function, spline, exponential 5P, parabola, Wei Bull,

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K-factor etc.

12) Calibration system: Selecting best test point according to reaction curve, do not need
to calibrate for second times; Calibration result is calculated automatically. Tracking
calibration function, the change of K value is presented on a drawing. 8 calibrations in
different concentration can be used for each item.

13) QC rule: At least including westgard and levey-Jennings QC rules.

14) QC method: Real-time QC, within-day QC, between-days QC.

15) QC Predefine different controls. More than 4 controls can be tested simultaneously
and QC could be insert randomly in the course of testing. QC diagram could be
storage, displayed and printed.

16) Colorimetric method: Colorimetric in reaction cup directly, and single-hole detection.

17) Monitor: Monitoring cuvette online, display whole reaction process in real time, skips
and marks the unqualified cuvette automatically.

18) Pre-diluents/Retest: The software could identify the sample which substrate is use up
and linearity is over range, for these samples, system could select pre-diluents test
and retest manually or automatically. The diluents time could be programmed. Max
dilute multiple is up to 250.

19) Data reset: Reselect measure point for abnormal sample (Substrate use up, over
range of linearity) and recount without retest.

20) Enzyme linearity check and expansion function: Search and check the linearity
reaction interval of enzyme automatically to get the real result.

21) User mode: Hospital mode, blood station mode, physical examination center mode
etc.

22) Item sequence: Item print and measuring sequence could be programmed.

23) Patient result and data storage: Store and backup automatically and permanently in
infinite quantity.

24) Software management: Multilevel authority management to guarantee the security of

information.

25) Network: Data exchange between LIS and HIS automatically

26) Barcode reader: The instrument supports the barcode scanning function. Supporting
codabar, interleaved 2of 5, code128, code39, code93, UPC/EAN and any other
barcode rules.

27) Printing function: Various printing format, support Chinese/English printing. User
could edit the format of report.

28) Light source: Long-life halogen lamp, auto-sleep. With liquid cooling system to cool
down the light.

29) ISE: Support ISE.

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2.5 Technical Parameter

1) Testing Speed: 300 tests/h (pure biochemistry), 540 tests/h (with ISE)

2) Sample Tray: 71 sample positions, they are consist of routine sample positions,
standard positions, quality control positions, probe washing position and STAT
position; Various samples can be mixed placed. Neonate ultramicro quantity cup,
primitive tube and plastic tube are appropriate for those positions. Offer up to 20
virtual sample trays, 1080 samples could be edited simultaneously in single time.

3) Reagent Tray: 60 reagent positions, two specification bottles are available.

4) Cuvette: 120 UV horniness material cuvettes (quartz cup is optional).

5) Optical System: A whole sealing, static, array and rear spectrophotometry system
composed of high resolution and halogen lamp, with 10 wavelengths for selecting
(340nm, 405nm, 450nm, 492nm, 510nm, 546nm, 578nm, 630nm, 700nm, 800nm)
and other two positions for option.

6) Absorbance Range: -0.5Abs-6.0Abs, resolution 0.0001Abs.

7) Reagent Refrigeration: Refrigerate temperature is 2℃-8℃

8) Sample Volume Per Test: 2 to 100μL , variable in 0.1μL

9) Reagent Volume Per Test: 5 to 500μL, variable in 0.5μL

10) Cuvette Light Path: It’s provides 5mm, 6mm and 7mm light paths for selecting.

11) Reaction Mixture Volume: 110μL~600μL (light path is 5mm), 130μL~750μL (light path
is 6mm), 150μL~900μL (light path is 7mm).

12) Wavelength Accuracy: ±1nm

13) Half Broadband: ≤6nm

14) Light Source: 12V/20W

15) Temperature Control: 37℃±0.1℃

16) Max. Reaction Time: 22minutes

17) Item Storage: Up to 1200

18) Power Voltage: 230V~, 50/60Hz, 850VA

19) Fuse: T8AL 250V

20) Water Consumption: ≤ 4L/h

21) Relative Humidity: 40%～85％

22) Environment Temperature: 10℃～35℃

23) The outside insulated resistance of single fault: ≤0.1Ω.

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CHAPTER 3 MEASURING PRINCIPLE

3.1 Principle

Lambert’s Beer Law:

When a parallel monochrome light beam goes through a light-absorbing object (gas, liquid
or solid), some photons are absorbed and the light intensity decreases from I0 to I, the
formula is:

I
 lg = εLC
I0

ε: Proportionality factor
I: Intensity of shoot-out light
I0: Intensity of shoot-in light
Measure I, I0, and L, and then calculate the concentration C according to the formula
above.

3.2 Assay Methods

3.2.1 Endpoint Assay

Endpoint assay means the concentration of measured item is calculated according to the
absorbance at the end of the reaction process.

1-point of Endpoint Assay

Endpoint assay in which absorbance is measured at a time point when absorbance stops
changing at the end of the reaction process. The reaction curve below explains the assay.

Formula: Concentration= (calculated absorbance - absorbance of reagent blank) ×K

[K is the absorbance coefficient i.e., Standard factor]

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Figure 3.2.1-1 1-point of Endpoint Assay

2-point of Endpoint Assay

End-point assay in which measurement is made twice at different points (at the beginning
and at the end of the reaction time) to obtain the difference of absorbance. Observe the
reaction curve below.

Formula: Concentration= (Absorbance 2 - Absorbance 1) ×K

[K is the absorbance coefficient i.e. standard factor]

Figure 3.2.1-2 2-point of Endpoint Assay

3.2.2 Two-point Assay

Measurement is made twice at two different optional points (except the start point and end
point of the reaction time) to obtain the difference of absorbance. Observe the reaction
curve below.

The formula is the same as 2-point of endpoint assay.

This assay is helpful to solute some non-specificity problem in some of the reaction.

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Figure 3.2.2 2-Point Assay

3.2.3 Rate Assay (Kinetic Method)

The concentration is obtained from the change in absorbance (ΔA/min) between the
specified measurement points. Observe the reaction curve below.

Linearity Range of Enzymatic Reaction

Figure 3.2.3-1 Rate Assay (Single Reagent)

Figure 3.2.3-2 Rate Assay (Double Reagent)

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 URIT-8021A Operating Manual

CHAPTER 4 OPERATION

4.1 Operating Step

Following show the operation step of instrument. Suggesting perform standard analyses
everyday after start-up and do control analyses.

4.1.1 Operating Step

Power on
4.2.1 Startup URIT-8021A
4.2.2 Check instrument state

Preparation of sample and reagent

4.2.4 Sample Preparation
4.2.3 Reagent Preparation
4.2.3 准备试剂 Create standard curve and
QC test
Place reagent on instrument
Place reagent and sample
Place sample on instrument
Place reagent on the instrument
4.2.5 Standard and QC order
Place sample on the instrument
4.2.7 Start analysis
4.2.9 Finish

Routine operation
4.2.5 Standard order
4.2.5 QC analyses order
Preparation of routine sample
4.2.6 Routine order
Place reagent on instrument
Place sample on instrument
4.2.6 Routine
Start analysis 4.2.7 Start analysis
4.2.7 Start analysis 4.2.9 Finish
4.2.7 开始分析

Analysis

Finish
4.2.8 STAT analyses
4.2.9 Finish
4.2.9 测试结束

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4.1.2 Start up

Firstly turn on power switch of analyzer and computer. Then check whether the distilled
water and detergent is sufficient, and be sure the waste solution barrel is empty. Wait
about 30 minutes for instrument preheating.

4.1.3 Create Standard Curve

It is suggested to perform standard analyses every day to obtain preferable result. The
following are the steps for standard analyses.

1) Place reagent on reagent tray and put a known concentration standard solution on
standard position of sample tray.

2) Apply to system for standard analyses.

3) Click “test” to start standard analyses.

4) Confirm new standard curve is created.

4.1.4 QC Test

After standard analyses, it is necessary to perform QC analyses to check the instrument’s

precision. Data of QC are saved in everyday operation to take as QC analyses basis.

There are two kinds of QC analyses: within-day variation QC and between-days variation
QC. Within-day QC is to check the data measured within a day. Between-days QC is to
check the data measured within different days. It is suggested to measure two control
samples in different concentrations every day, and each control sample should be
measured at least twice.

The following are the steps for QC analyses.

1) Place control sample in the control position of sample tray.

2) Apply to system for control analyses.
3) Click “test” to start QC analyses.
4) Check the QC chart.(Refer to 5.4.3 for QC chart and 6.3 for QC rules)

4.1.5 Test Patient’s Sample

Operating steps are as following:

1) Put patient’s serum, urine or other samples on sample tray.

2) Apply system for routine item analyses.
3) Click” test” to start.
4) Repeat 1-3 steps if necessary.
5) Check the result and if necessary, review and modify it.

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4.1.6 Finish

Perform rinse and log off the system after finishing analyses and then turn off power
switch.

4.2 Basic Operation

4.2.1 Start up

Start up by following the below steps:

1) Turn on the main power of analyzer

2) Turn on the computer
3) Open the top cover of instrument
4) Starting the operating system, the login window as follows, figure 4.2.1.

Figure 4.2.1
5) Input the registered doctor’s name and the corresponding password to enter system
to operate analyzer.

CAUTION
User authority management is applied to limit certain function for low permission
user, which is benefit for user to manage the software reasonably.

NOTE
Please refer to figure 5.5.1.1 to set the name and password.

4.2.2 Check Instrument State

Check the instrument state before running

1) Check the distilled water, detergent and waste solution, if distilled water or detergent
is insufficient, replenish it. Empty the waste barrel before analyses.

Biological Hazard
DO NOT touch the detergent or waste solution. If it adheres to hands or clothes,
wash it off with water immediately. If it splashes into eyes, wash it off with water
immediately and consult a doctor.

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2) Verify that reagent lids have been removed and the rest of reagent volume is sufficient
for your analyses.

CAUTION
If the rest volume in reagent bottle is insufficient for analyses, replace the whole
reagent bottle. DO NOT refill the reagent to the bottle. If refilled, data error may
be caused.

3) Check aspirating probe and stirrer. Verify that the aspirating probe is not blocked.
Make sure there are no stains and crystals adhere on the surface of probes and
stirrer.

4.2.3 Preparation of Reagent

1) Be sure to use the certified reagents. Read through the reagent instructions and set
up parameters properly before analyses. For item parameter setup, refer to 5.2.1 and
5.2.2.

2) If reagent is insufficient, replace it with a whole new bottle. Place the reagent bottle in
the specified position according to the preset reagent parameters.

3) Reagent should be stored at temperature of 2-8 ℃. Long-time exposure in the air may
deteriorate the reagents.

Biological Hazard
Be careful not to spill out reagent. If reagent is spilled, wipe the area by dry fabric
immediately.

4.2.4 Preparation of Sample, Standard Solution and Detergent

4.2.4.1 Sample Preparation

Add samples into special sample cups or tubes, and then select corresponding sample
position at test interface.

CAUTION
Before transferring samples, observe their appearances and shapes to see if
icterus, hemolysis or chyle exists.

4.2.4.2 Preparation of Standard Solution

Add proper volume of standard solution into sample cup and place the cup in the standard
position.

4.2.4.3 Preparation of detergent

Dilute detergent proportionally, and then add into the detergent barrel. Be sure the solution

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level not exceeds the marked highest line on detergent barrel.

Biological Hazard
1) DO NOT mistake the detergent, e.g., acid solution and alkaline solution
will produce toxic gas when they are mixed.

2) If detergent is spilled, wipe the area by dry fabric or tissue. Leaving the
spill will erode the parts of the instrument.

Biological Hazard

1) When opening the lid of detergent barrel, be careful to avoid touching the
solution. If the detergent adheres to your skins or clothes, wash it off with
water.

2) If the detergent splashes into eyes, wash it off with water immediately and
consult a doctor.

4.2.5 Registration of Standard and QC

4.2.5.1 QC Registration

1) Select “Chemistry analyses QC Management QC setup” to set the QC

parameter

2) Select “Standard and QC Standard and QC”, then apply QC item test.

3) QC data is automatically processed by system after finishing analyses.

NOTE

The QC test could be done when the routine test is going on, just set the “sample position”
as QC position, such as the position of C1 or C2. The system will identified it as QC and
process the QC result automatically.

4.2.5.2 Standard Registration

1) Click “Chemistry analyses Item Parameter Methodology”, then set the

parameter of standard solution.

2) Select “Standard and QC Standard and QC”, then apply standard item test.

3) Save data automatically after finishing test.

4.2.6 Routine Sample Registration

It is necessary to register analytical items and patient information for each routine sample
before analyses according to application form. Figure 4.2.6-1.

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Figure 4.2.6-1

There are two forms to write the working list:

1) Applied operation of single sample.

2) Applied operation to retest the single sample.

4.2.6.1 Editing Application Form of Single Sample

1) Select “Routine Analyses” from “Chemistry Analyses” or click the shortcut icon
to enter the “Routine Entry Screen.

2) Setup the basic information of sample ID, sex, age, sample cup, initial cuvette No. and
analyzing date etc.

3) Select analytical item by clicking the target item. Click again could switch between
“select” and “unselect”.

4) Click “ADD” to add the edited sample to the list.

5) Click “NEW” to edit next sample. Repeat the step of 2) to 4) could add more sample
analyses.

NOTE
Select combined item directly for choosing analytical item. For editing of combined item,
see 5.2.3; for editing of chemistry item, see 5.2.1.

4.2.6.2 Editing the Application Form of Retested Single Sample

1) Operate according to the 1 to 3 steps of “Application of Single Sample”.

2) Click “COPY”, select the “Same Cup” (by placing “√”mark) and enter the repeating

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times, see figure 4.2.6-2.

Figure 4.2.6-2

NOTE

If the “Same Cup” is not selected, the system will recognize the current sample
position as the initial sample position and orderly test samples at different
positions for the same analytical items.

The created List will include sample ID, sample cup No. and analytical item. See figure
4.2.6-3.

Figure 4.2.6-3

The function of “Pre-dilution” is provided in the list. System could automatically pre-dilute
the high concentration sample and then retest, the multiple of dilution could be set by user.

Function of keys:

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: Creating one new sample ID and sample cup

: Add a sample test to the current working list

: Copy the same item group for more samples.

: Pre-dilutes target item.

: Delete the selected item

: testing the content of current working list.

4.2.7 Analyses

Do the following steps after finishing the preparation:

1) Check parameter setup, sample positions and reagent positions.

2) Check list of item, contents of standard and QC.

3) Click “TEST” to enter the Testing Screen.

4.2.8 STAT Analyses

For sample that needs to be tested emergently, you can use the function of STAT
analyses.

Click “STAT Analyses” or click the icon to perform emergent sample test. Specific
operation is the same as routine sample. See figure 4.2.8

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Figure 4.2.8

CAUTION

The STAT Entry Screen is similar to the Routine Entry Screen. Pay attention
not to confuse them when doing analyses. STAT samples must be placed at
the STAT positions, such as E1,E2 etc.

CAUTION

The STAT analyses are performed only after routine test started.

4.2.9 End of Analyses

1) Normal Exit
Upon completing the test, system will stop and the test data is processed and stored
automatically.

2) Emergent Exit
If you have to abort the test, click the “Emergency exit” key. In this case, the test is
cancelled.

CAUTION

If the emergent exit function is executed, all the sample tests which applied will
stop and data will loss. Re-applied if it is need to test these samples
continuously.

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4.3 Obtain Result

It’s necessary to check the test result after finishing the analyses.

4.3.1 Registration of Sample Information

After finishing the test, enter the corresponding patient’s information to complete the test
report.

Select “Register” or click the icon to enter the registration interface. The sample
information could be registered in this interface, such as “Report Date”, “Sample ID”,
“Name”, “Sex”, “age”, “Inpatient ID”, “Patient No.”, “Department”, etc.

Click “Calculated Item”, the item will display. Click “SAVE” to edit next sample and repeat
this operation until complete all the sample editing.

Printout: Offer various print formats for different needs.

4.3.2 Modification of Test Result

Click “Data Processing Result Modification” to modify the result when abnormal
result appear. Select the date and item that need to modify, system will display the data of
selected item. Suggest calculating coefficient according to the below formula:

Coefficient= QC target value/QC real value

Input the calculated coefficient into the blank box of coefficient, click “Modify”, system will
modify all intraday data under this item automatically, and then click “SAVE” to save the
data.

CAUTION
Take objective factors, such as clinical symptoms or sample characters into
consideration before deciding to modify test results. The modified coefficient
should be calculated combined with QC results in recent days. To avoid
misdiagnosis, doctor or lab personnel should supervise the modification of test
results.

4.4 Query of Analytical Result

Select “Data Processing Result Review” or click icon to enter the query
interface. The analytical result could be queried in this interface. System provided various
index functions, such as query by analytical date, patient’s name, patient No. and doctor
etc.

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NOTE

Reports can also be printed out in accordance with the laboratory’s requirement
in this screen.

4.5 Analytical Curve Display

System provides the interface of “Chemistry Analytical Data Display” for lab to depth
analyze the result. Select “Data Processing Analytical Curve” to analyze the
analytical data. Furthermore, this function could examine the QC and standard curve, and
analyze the accuracy of the QC and standard.

4.6 Database Maintenance

Backup or restoration various test data to avoid data loss. Database maintenance consists
of two parts. Operating as following steps:

4.6.1 Database Backup

1) Select “Data Processing Database Maintenance”.

2) Select “Database Backup”; backup the data by time according to the lab requirement.

3) Click “Backup” and exit.

4.6.2 Database Restoration

1) Select “Data Processing Database Maintenance”.

2) Select “Database Recover” and then restore data according to the requirements.

3) Click “Recovery” and exit.

NOTE
Laboratory need to set backup manually for the system without the function of
automatic backup. The data of which kept a backup is automatically deleted from
system, user must restore database to view the backup data if necessary.

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CHAPTER 5 ADVANCED SETUP

5.1 System Menu

Chemistry Analyses Item Parameter Setup Routine Item Parameter

Special Item Parameter

Item Combined Setup

Calculated Item Setup

Sequence Setup of Item Display and Printout

Chemistry QC Management QC Setup

Routine Analyses QC Result Processing

STAT Analyses Analyses of QC Diagram

Special Analyses
Standard and QC Analyses

Reading of A/D Signal

Maintenance Rinse Aspirating Probe and Stirrer

Cuvette Rinse

Reading of Cuvette Signal

Parameter Setup
System
Parameter Setup of Communication Port and Hospital Name

Hospital Information setup

Chart Color

Data Processing Sample Registration

Query of Analytical Result

Modification of Analytical Result

Display of Analytical Curve

Database Maintenance Database Backup

Help Help
Database recovery
About Software

Software Registration

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5.2 Chemistry Analyses

5.2.1 Parameter Setup of Routine Item

Parameter setup of routine item is the first step of chemistry analyses. Setup the
parameter accurately could guarantee the accuracy of analytical result. The basic factors
for each analytical method includes name of chemistry item, testing method, wavelength,
reagent volume, reagent position, incubation time, measuring time, sample volume, blank
low value, blank high value, normal low value, normal high value, unit and decimal etc.
The setup steps are as follows:

1) Select the “Chemistry Parameter —> Item Parameter” or click icon to enter the
parameter setup interface.

2) Input the item name, includes the abbreviation and other name. See figure 5.2.1-1.

Figure 5.2.1-1

3) Setup the parameter of new adding analytical item according to the instruction or lab
item file. See figure 5.2.1-2.

Figure 5.2.1-2

Definition of Main Parameter:

1. Method: Endpoint, Rate method (Kinetic method), 2-point endpoint, 2-point rate
method (2-point kinetic method), Multi-standard method and Dual-wavelength method
etc.

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2. Wave.1: Measured wavelength. For Dual-wavelength Method, “Wave.1” is the primary

wavelength.

3. Wave.2: Secondary wavelength for Dual-wavelength Method. If “NONE” is selected,

Single-wavelength method is valid.

4. Decimal: Decimal place for test results.

5. Unit: Unit for analytical result.

6. Priority: PRI-1with the highest priority level; PRI-9 with the lowest priority level.

7. Modified factor: Modifies the standard factor of item.

8. Standard Factor and Standard Value: Endpoint, Rate method (Kinetic method),
Permanent Time method and Dual-wavelength method are all analyzed with standard

and factor. See figure 5.2.1-3. Click icon , select standard position and input the
corresponding standard value. If the Factor method is adopted, the corresponding
standard factor has to input and set the standard value as “0”. As shown in figure
5.2.1-3, if the standard number is more than“1” (not include “1”), that is the
multi-standard method, so the Multi-standard method could be used.

Figure 5.2.1-3

9. Sample volume: The sample volume to be aspirated into cuvette. Please setup the
volume according to the reagent instruction and lab relative file.

10. First Reagent Volume: The reagent volume to be aspirated into cuvette in the Single
Reagent Method. About the reagent volume in the Dual-Reagent Method, please refer
to the reagent instruction and lab requirement.

11. Secondary Reagent Volume: The secondary reagent volume in the Dual-Reagent
Method, please refer to the reagent instruction and lab requirement.

12. Incubation Time: For endpoint method, incubation time is from the mix of sample and
reagent to the end of reaction process. For Two-point method, incubation time is from
the first measured point to the second measured point. Two incubation time has to be
set in the Dual-Reagent method. Please refer to the reagent instruction and lab
requirement.

13. Test Point: The number of test points when reading absorbance continuously after
incubation.

14. Normal Value Range Setup: blank low value and blank high value are used for judging
the reagent quality; please refer to the max absorbance value to input the value. The

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normal low value and normal high value are used for judging the analytical result. The
linear range could be input by refer to the corresponding reagent information.

NOTE
Lab could set the range of item reference value according to local actual test
situation and lab’s data statistical.

4) Please click “SAVES” to complete setup after setting all the parameters.

CAUTION
All the new setting data will lose if not click “SAVE”.

5.2.2 Parameter Setup of Special Item

The software system expands the function of “Special Item Parameter” for users. It
provides that the analytical results detected by other instruments can be transmitted to the
software system for a unified printing format. See figure 5.2.2

1) Input the corresponding item name and other name.

Figure 5.2.2

2) Select the data type between “Char” and “Float”.

Char: Test results will be indicated with character system, such as “+”, “_”, “Negative”
or “Positive”.

Float: Test results will be indicated with numerical data. The decimal, normal high
value and normal low value of result could be input.

3) Click “SAVE” button to complete all setup.

5.2.3 Item Combined Setup

The analytical item will group together and to be given a separate code which name as
“Combined Item”. Add or delete item according to the lab requirement. The combined item
will appear in the interface of “Combined Item Region” for analyses after the correlative
setup has been done.

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NOTE
“Item Combined” means multi items combined to a separate code, that is a process; But
“Combined Item” is a code after the “Item Combined” has been proceeded, which is a
name.

5.2.4 Chemistry Calculated Item Setup

Some of the analytical items have to be calculated and the corresponding result is for
assisting the doctor to do diagnosis. These results are the calculated results, and the
items named as calculated item which function is completed setting in the selection of
“Calculated Item Setup”.

NOTE
Take note of replacing the “-”with “_” contained in item name when entering
arithmetic expression.

5.2.5 Sequence Setup of Item Display and Printout

Items can be sequenced for display and printout, including analytical items, external items
and calculated items. Click “Item Sequence” to enter the interface for setup.

5.3 Special Analyses

5.3.1 Standard and QC Analyses

The applied analyses of standard and QC could be done in this interface. Please see 4.2.5
for specific operations.

5.3.2 Reading of A/D Signal

The A/D value and absorbance value of all filters could be read. This function is only for
the personnel who authorized by URIT to debug.

CAUTION
URIT is not responsible for any consequence resulting from changed A/D
values without permission or authorization by URIT.

5.4 Chemistry QC Management

System support multilevel QC test. The correlative QC parameter has to be set for QC test.
Click “Chemistry QC Management” for setting. See as the figure 5.4.

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Figure 5.4

5.4.1 QC Materials Setup

Some relevant parameter materials will be accompanied with QC materials when delivery.
The general characteristics of the QC material could be confirmed by inputting its basic
data. The laboratory personnel could input the basic parameter into the system when
introduce the new QC materials. The “QC setup” includes the basic setting of target value,
SD value and batch number.

NOTE
Chemistry Item list of QC is added or deleted in the selection of “Routine Item
Parameter”. See 5.2.1.

NOTE
The laboratory should set the target value and SD value for the new QC
material. The target value must be defined according to the presented
determination method. The parameter which supplied by manufacturer only for
reference. See 6.2.3 for specific setup steps of target value and SD value.

5.4.2 QC Result Processing

Select a chemistry QC item, system will display the corresponding QC information

automatically. Laboratory personnel will process the QC result by date and save to the
system.

5.4.3 Analyses of Chemistry QC Diagram

Select a chemistry QC item, system will display the corresponding QC information

automatically. Laboratory personnel will show the QC diagram and print out by input the
date. The analyzer provides various QC analytical methods; include Westgard multi rule
and Levery-Jennings QC rule.

NOTE
Laboratory could select individual QC standard, see 6.3 for QC diagram
analytical method.

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5.5 Systematic Parameter Setup

Systematic parameter setup is introduced to setup individually for laboratory.

5.5.1 Hospital Information Setup

Hospital setup includes “setup of operator”, “setup of doctor”, “setup of department”.

5.5.1.1 Setup of Operator

Statistics analyses of the operator’s job, convenient for laboratory management. The
figure as below:

Figure 5.5.1-1

Startup URIT-8021A chemistry operating software, figure 5.5.1-2 will appear, suggested to
input name of “Operator” and corresponding “Password”, setup the work cord and name
here. The work cord is used for work registration and printing, utilize the examination
doctor cord to input the corresponding password in the below figure 5.5.1-2.

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Figure5.5.1-2

Corresponding password could be setup in the figure 5.5.1-2, if another password existed
in the system, the input filed of “Old Password” in the input status. System will save the
new password and default as operating password.

High priority will allow the operator to modify “Routine Item Parameter”, “Item Combined
Setup”, “Calculated Item Setup” etc; while low priority won’t.

NOTE

System software adopts strict multi-authority management to guarantee the

safety of data. Please remember and keep your password in private.

5.5.1.2 Setup of Doctor

Cord can be used to represent doctor, such as number, symbol or letter; doctor’s name
also can be used. Setup according to specific condition.

5.5.1.3 Setup of Department

Cord can be used to represent department, such as number, symbol or letter, department
title also can be used. Setup according to specific condition.

NOTE
“Doctor” and “Department” are setup by laboratory itself.

5.5.2 Setup of Chart Color

Laboratory can setup the chart color individually, see figure 5.5.2:

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Figure 5.5.2

5.5.3 Setup of Serial Communication Port and User’s Name

Select setup dialog box of communication port in the menu.

Figure 5.5.3

System will test all communication ports automatically and a dialog box will appear to
prompt user to select communication port. User’s name should be input in this function
module, and the name will be the title of report sheet and other diagram.

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CHAPTER 6 QUALITY CONTROL ANALYSES AND

CALIBRATION

6.1 General Information

The reliability of test result is determined by two aspects: One is the precision, which
means test results are stable in repeatability. Precision can be guaranteed by establishing
perfect room quality control system; the other one is accuracy, which means test results
close to target value. Accuracy can be guaranteed by proper assay and calibration. It is,
therefore, necessary to select certified control sample and calibration solution, and use
them strictly according to their instructions.

6.2 Quality Control

6.2.1 Type of Quality Control Materials

1) Freeze-dry control, liquid control and mixed control serum, classified according to
physical property.

2) Fixed value and non-fixed value control sample, classified according to the presence
and absence of fixed value. Different inspection body can choose more than one
quality control as quality control.

6.2.2 Use and Storage

1) Strictly following the instruction of quality control to operate.

2) Make sure the quality of control solution when redissolved from freeze-dry control
sample is stable.

3) Make sure the dilution ratio is accurate and consistent each time redissolving
freeze-dry control sample.

4) DO NOT shake control sample fiercely when redissolving freeze-dry control sample.

5) Store control sample according to requirement. DO NOT use expired product.

6) Perform QC analyses under the same operating conditions as that of sample

analyses.

6.2.3 Setup of Target Value, SD and Control Limit

QC target value and control limit are usually provided by the control samples supplier, also,
you can determine them through the following methods:

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1) Setup of interim target value (mean value) and SD

2) Perform QC analyses at least 20 times with a new batch of control sample. Calculate
the mean value and standard deviation from the obtained QC data.

3) Setup of regular target value (mean value) and SD

4) Obtain the accumulated mean value of original 20 QC data as the target value while
the accumulated mean value of 3~5 month QC data as the standard deviation.

5) Setup of control limit

6) Control limit is the multiplier of standard deviation. Control limit of analytical item is
determined according to different QC rules.

6.2.4 QC Procedures

QC procedure consists of two systems; they are “Chemistry QC Management” and “QC
Analyses”. Select “Chemistry QC Management” in the “Chemistry Analyses”, its function is
setup the parameter before QC Analyses and process the QC data, such as setup the QC
target value, QC batch number and SD value etc. Select “QC Analyses” in “Special
Analyses” to begin QC Analyses, QC data will saved in system automatically and a QC
diagram will generate for chemistry analyses; QC Analyses could be add to routine test
interface. See 4.2.5 for application of QC Analyses.

6.3 Quality Control Method

6.3.1 Levey-Jennings Method

1-2S rule exceed the average value ±2SD is judged as out of control.

1-3S rule exceed the average value ±3SD is judged as out of control.

6.3.2 Westgard QC Rule

1-2S Warning
1-3S Random Error
2-2S Systematic Error
R-4s Random Error
4-1S Systematic Error
10X Systematic Error

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Figure 6.3-1 Westgard Method of Multi-rule Quality Control

1-2s Rule: When one QC result exceeds ±2SD, regard as “warning” into next standard.

Figure6.3-2, 1-2s QC rule

1-3S Rule: When one QC result exceeds ±3SD limit, this is judged as random error.

Figure6.3-3, 1-3s QC rule

2-2S Rule: The QC results of two successive are both exceed +2SD or -2SD, this is
judged as systematic error.

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Figure 6.3-4, 2-2s QC rule

R-4s rule: When one QC result exceeds mean value +2SD, and the other exceeds -2SD,
this is judged as random error.

Figure6.3-5, R-4s QC rule

4-1s rule: When four consecutive QC results exceed +1SD or -1SD, this is judged as
systematic error.

Figure6.3-6, 4-1s QC rule

10X Rule: When 10 consecutive QC result fall on the + or – side, this is judged as
systematic error.

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Figure6.3-7, 10x qualify control rule

6.3.3 Reasons of Random Error

Below are the possible reasons of random error.

1) Inaccurate dispensing volume (sample, reagent)

Aspirating mechanism is leakage; air bubbles in flow path; contaminated probe;

deflective injection of reagent, etc.

2) Optical system failure

Lamp is faulty.

3) Metamorphic Reagent

Metamorphic Reagent

4) Adverse quality-control samples

Use of wrong control sample;

5) Inadequate wash

Stirrer wash is inadequate.

6) Adverse mixture

The depth of stirrer to cuvette is excursion; stirrer mechanism faulty.

6.3.4 Reason of Systematic Error

1) Inaccurate standard

The dissolvent of standard solution is inappropriate

2) Metamorphic reagent

The reagent is metamorphic, and the batch number is various.

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3) Temperature

The temperature control is inappropriate.

6.4 How to Deal With Out-of-Control

1) Fill in Out-of-Control report and report to your lab supervisor.

2) Simply and quickly review the operating procedure to find out the possible reasons.

3) If no evident error is found, move to the following steps for further checkup.

 Retest the out-of-control item by using the same bottle of control sample. Strictly obey
the operation flow to check if the out-of-control is due to operation incorrectly or
random error. If retest result falls outside the acceptable range, proceed to the next
step.

 Retest the out-of-control item by using a new bottle of control sample (same lot). If
retest result is in control, the previous bottle of control sample may be to blame. If
retest result still falls outside the allowable range, proceed to the next step.

 Retest the out-of-control item by using a new lot of control sample. If retest result is in
control, the previous lot of control sample may be deteriorated. Then check the
expiration date and storage condition. If retest result still falls outside the allowable
range, proceed to the next step.

 Perform instrument maintenance; retest the out-of-control item. Check the instrument
state; check whether the light source or filter are changed or not; and whether the
cuvette need to wash or replaced. Furthermore, replacing reagent. If the retest result
still falls outside range, proceed to the next step.

 Recalibration and retest out-of-control item. Perform calibration by using new

calibrating solution. Proceed to the next step if the result still falls outside range.

 Obtain technical help. If you cannot get the in-control result after performing the above
five steps, contact reagent manufacturer or URIT to get more technical support.

6.5 Calibration and Procedures

Calibration solution contains the known quantity object, which is used for calibrating the
value of this method; the calibration solution is concerned with the method, reagent and
instrument. The function of calibration solution is to reduce or eliminate systematic error
caused by instrument and reagent. It should be better to use human serum matrix to
reduce matrix effect.

6.5.1 When to calibrate

It is suggested to perform calibration every six months or under the following situations:

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 When initially installing and running the instrument.

 When changing reagent batch number or type, unless specified by the lab that the
change will not influence the precision.

 After replacing the major components, such as lamp, sampling mechanism, probe, or
cuvette etc.

 After performing a preventive maintenance on the instrument.

 When control result shows abnormal offset, tendency, or falls out of the acceptable
range and it cannot be corrected by routine tests.

6.5.2 Calibrate Procedures

There are two ways to carry out calibration:

1) Applying standard analyses in “Special Analyses”

Select “Special Analyses” to applying standard analyses for each item, analytical data
will save in system automatically and for analyzing.

2) Select the item which need to be calibrated in “Routine Item Parameter”

Input and save the concentration value of calibration material into the standard column.

Enter “Routine Analyses” interface, if “Concentration of Standard Material” has been input
when setup the parameter of analytical item, the selection of this item will appear in the
“Standard list”.

Select the item in the “Standard” list for standard analyses. Analytical result will be
processed and saved automatically and to be the standard of this item (standard factor).

NOTE
See 4.2.5 for standard application and test.

NOTE
System default the value of “Standard Factor” as 1 when newly built an item; and
system will calculate the result according to the standard factor “1” if not
modified.

NOTE
It is suggested that all calibration work should be written down and complied into
documents. What should be emphasized is that the fixed-value control serum
should never be used as standard solution.

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CHAPTER 7 MAINTENANCE

This chapter is mainly introducing the knowledge of maintenance; involve the

maintenance of main components.

7.1 Analyzer Maintenance

In order to keep the analyzer in the best work state, periodic maintenance for specific
components should be done since it can guarantee the analyzer under the no fault work
status and stabilize the test result.

Figure 7.1-1

7.1.1 Probe and Stirrer Rinse

Select “Probe and Stirrer Cleaning” in the menu of “Maintenance” or click icon to
rinse the probe and stirrer. It is aimed at ensuring cleanness and avoiding resides in tubing.
The rinsing time could be setup. See figure 7.1.1.

Figure 7.1.1

: To initialize all the motion components to initial position.

: Click “Wash” to begin.

NOTE
Please perform at least 5 times rinse when turn on and turn off instrument.

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7.1.2 Cuvette Rinse

Select “Cuvette Rinsing” in the menu of “Maintenance” or click the icon to rinse the
cuvette. It is aimed at keeping cleanness and avoiding solution resides. The functional
interface as follows:

Figure 7.1.2

NOTE
It is very important to rinse all the cuvettes at least one time when turn on and
turn off the instrument.

7.1.3 Reading of Cuvette Signal

Select “Reading of Cuvette signal” in the menu of “Maintenance” or click icon . It is

aimed at eliminating the difference among cuvettes. System test and save blank
absorbance of each cuvette separately also participate calculation of retrospective
chemical test. In the following figure, the numbers in the left frame are cuvette numbers
and in up frame are wavelengths. All the cuvettes blank data are saved in this interface.

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Figure 7.1.3
Functional Button:

: Full filled all cuvettes with distilled water

: Pump off all the distilled water from cuvette. The function is effective
only there is water in the cuvette

: Reading the absorbance of all cuvettes and result will not be saved

: Repeat reading absorbance of all cuvettes, averaged value and save

them.

: Page turning, display absorbance of 15 cuvettes and totally 120.

7.2 Maintenance

Please do the following maintenance job to keep the analyzer in the best work state and
use safety:

7.2.1 Daily Maintenance

1) Before daily work, verify that detergent and distilled water are enough for your
analyses. If insufficient, replenish the detergent barrel and distilled water barrel.

2) Empty the waste barrel if waste solution exceeds the warning line marked on the

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waste barrel.

3) Check the mechanical movement of sample probe, reagent probe and stirrer. Check if
probes are clogged or not. Inspect the exterior of probes and stirrer for contamination
and dirty. Clean them if necessary.

Biological Hazard

Put on protective gloves to avoid contacting chemical solution. If it spill to human

body, wash it off with water immediately consult doctor if necessary.

4) Perform at least 5 times “Probe and Stirrer Cleaning” and one time “Cuvette Rinsing”.
Consult 7.1.1 and 7.1.2 for details.

5) Perform “Add water “before power off to guarantee the cuvette full of distilled water.
See 7.1.3 for specific operation.

7.2.2 Weekly Maintenance

1) To reduce cross-contamination, it is necessary to wash sample probe, reagent probe

and stirrer weekly. Probes and stirring rod can be washed automatically through the
maintenance procedure, or manually according to following steps:

a) Preparing items: Alcohol, Fabric, nozzle cleaner.

b) Wipe the exterior of sample probe, reagent probe and stirrer using a fabric
moistened with alcohol.

c) Introduce nozzle cleaner from the probe end to clean it.

2) Rinse the needles of eight-step washing station according to the method that rinses
the sample probe and stirring rod.

NOTE
Be careful not to bend or scratch the probe when cleaning them.

3) Select “Cuvette Signal” to check if cuvette blank value is within acceptable range or
not. If outside the range take out the relevant reaction cuvettes together with the
cuvette racks from the reaction tray. Observe the cuvettes carefully and replace them
if necessary.

NOTE
To get optimum data, DO NOT read the cuvette blank until the light source lamp is
stable. It may take 25 minutes to complete a warm up time.

NOTE
Be careful not to scratch the reaction cuvettes when taking them out.

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Biological Hazard
Put on protective gloves to avoid contacting chemical solution. If it spill to human
body, wash it off with water immediately.

4) Turn off the refrigeration switch of the instrument. Using fabric moistened with water
or detergent, wipe the instrument’s panel board.

CAUTION
Operate carefully to avoid scratch to instrument.

7.2.3 Monthly Maintenance

1) Do as weekly maintenance.

2) Check flow paths and tube connectors for leakage or clogs.

7.3 Longtime Disuse Maintenance

If instrument has been disused over two days, perform the following steps before turning
off and after starting up.

1) Add new distilled water to distilled water barrel, meanwhile, add detergent to detergent
barrel.

2) Enter the maintenance program to wash the flow paths and cuvettes at least twice.

7.4 Preventive Maintenance

Periodic checkup and inspection ensure the instrument performance. It is recommended,

therefore, to carry out preventive maintenance periodically.

The preventive maintenance includes not only checkup and repair, but also the following.

1) Routine checkup and periodic checkup.

2) Periodic maintenance for parts subjected to long-term use or abrasion.

3) Secure a sufficient quantity of spare parts.

4) Improvement and control of operating conditions, such as temperature, humidity,

water quality, dust and gas, insects, foreign matter, etc.

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 URIT-8021A Operating Manual

CHAPTER 8 TROUBLESHOOTING

This chapter lists the various malfunctions, along with probable causes and recommended
remedies to correct the problem quickly and easily. If the problem still exists after following
the recommended remedy, contact URIT for Technical support.

CAUTION
Handle malfunction with utmost care and confirm if it is necessary to cut off the
power supply at the first.

Biological Hazard

Put on protective gloves to avoid contacting chemical solution. If it spill to human

body, wash it off with water immediately.

8.1 Troubleshooting Guide

To eliminate malfunction easily and correctly, users should read through the Operating
Manual and be familiar with the routine operation and maintenance of URIT-8021A.

In general, there are three steps to handle with malfunction:

 Step 1: Confirming Malfunction

Users should not only confirm the malfunction, but also clearly know what the normal
status should be when the malfunction is eliminated.

 Step 2: Classifying Malfunction

Malfunction can be categorized into three types.

 Malfunction relating to hardware

 Malfunction relating to software
 Malfunction relating to operation and analyses.

If malfunction relates to the hardware or software, contact your local distributor or URIT. If
malfunction relates to the operation and analyses, refer to the troubleshooting table below
for solution.

 Step 3: Eliminating Malfunction

The maintenance engineer authorized by URIT takes proper measures to correct the
problem.

Users can also eliminate the malfunction under the directions of maintenance engineer.

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8.2 Obtaining Technical Help

Our Customer Service Office is available to help if the problem is beyond the scope of this
manual or if you need more technical assistance from URIT. Before calling, please identity
the following information:

1) The instrument’s model;

2) The serial number of instrument;
3) The specific symptom and operating condition;
4) The data and report relating to the problem.

8.3 Troubleshooting Method

The troubleshooting table below presents the various problems and malfunctions that may
occur during operation. If the problem can not be solved through the recommended
methods, contact URIT please.

NOTE
For replacing parts of the instrument, refer to Appendix A.

Table 1 Troubleshooting

SN SYMPTOM POSSIBLE CAUSE REMEDY

1) Connect power cord correctly.
1) Incorrect connection with 2) Check if the power receptacle is in
power cord. good condition.
2) No electricity with power 3) Replace fuse(8A)
Instrument is not receptacle. 4)Confirm select the correct connector at
1 active when power 3) The safety fuse is fusing [System parameter—instrument
is on. 4) Improper COM interface is parameter—COM set]
selected. 5) Make sure the RS232 communication
5) Communication cable cable is connected to PC correctly.
error. If the problem still persists, contact your
local distributor or URIT.
1) Select [Maintenance—Cuvette rinse],
Check if reaction cuvettes are dirty or
Cuvette dirty or damage damage. Replace them if necessary
2 Cuvette blank error
Light source aging 2) Replace light source.
3) If the problem persists, contact your
local distributor or URIT.
1) Check or replace the lamp holder
1) Bad contact of lamp
2) Replace the lamp.
3 Lamp is dark holder.
3) If the problem persists, contact your
2) Lamp is burned out.
local distributor or URIT.

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1) Check flow path tubes. Reconnect or

replace tubes if necessary.
1) Air leaks in the flow paths. 2) Reconnect meter regulator. Eject air
Inaccurate aspirated 2) Air bubbles are formed in bubbles.
4 volume of reagent or meter regulator. 3) Unclog or replace probe.
sample. 3) Probe is clogged. 4) Check magnetic valve and replace it if
4) Magnetic valve problem. necessary.
5) If the problem persists, contact your
local distributor or URIT.
Water or detergent 1) Reconnect the tube or replace it.
1) Flow path tube is leaky.
does not come out 2) Unclog the tube.
2) Flow path tube is clogged.
5 through the probe 3) Replenish water or detergent.
3) Water or detergent is used
washing pool or 4) If the problem persists, contact your
up.
stirrer washing pool. local distributor or URIT.
1) Reconnect the tube or replace it.
2) Unclog the tube.
1) Flow path tube is leaky.
Adding or draining 3) Check the vacuum pump and replace it
6 2) Flow path tube is clogged.
water is abnormal if necessary.
3) Vacuum pump error.
4) If the problem persists, contact your
local distributor or URIT.
1) Check the wire of light coupling or
A certain movable Light coupling is short replace the light coupling.
7
part is out of control. circuited or broken. 2) If the problem persists, contact your
local distributor or URIT.
1) Check the liquid level sensor board and
1) Liquid level sensor board replace it if necessary.
Liquid level sensor is defective. 2) Reconnect the liquid level sensor
8
is out of order 2) Bad contact with liquid board.
level sensor board. 3) If the problem persists, contact your
local distributor or URIT.
1) Select “maintenance” –-- “cuvette
rinse” to check whether cuvette is dirty.
1) Cuvette is dirty or
Clean or replace the cuvette.
breakage.
2) Check sample injector and tube
2) Inaccurate aspirated
whether leakage existed.
volume of reagent or sample.
Inaccurate test 3) Replace the lamp.
3) Lamp is deteriorated.
9 result or poor 4) Set the parameter follows the operation
4) Parameters of analytical
repeatability. manual. Make sure the instrument is well
item are set improperly.
grounded by means of the ground pole.
5) Ground wire is absent with
5) Check if the reagent is certified.
power supply.
Perform recalibration.
6) Reagent problem.
6) If the problem persists, contact your
local distributor or URIT.

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1) Turn the refrigeration switch off, slowly

rotate the problem parts and observe if
there is abnormal noisy or if it is stuck.
1) Communication error.
2) Enter into system parameter” interface,
2) Mechanical parts are loose
select “Engineer set” to adjust parameter.
Abnormal motor or stuck.
10 (Only accessible to professional person
movement 3) Light coupling joint of
authorized by URIT).
motor is loose.
3) Check the light coupling and replace it
4) Light coupling is defective.
if necessary.
4) If the problem persists, contact your
local distributor or URIT.

1) Replace the stirrer motor.

1) Stirrer motor is broken.
Stirrer does not 2) Reinstall the stirrer motor.
11 2) Bad contact of stirrer
work. 3) If the problem persists, contact your
circuit.
local distributor or URIT.

1) Check the flow path tube. Reconnect or

replace the tube if necessary.
2) Check the magnetic valve and replace
Water leaks from 1) Flow path tube is leaky.
it if necessary.
12 nozzles of cuvette 2) Magnetic valve problem.
3) Check the vacuum pump and replace it
cleaner. 3) Vacuum pump problem.
if necessary.
4) If the problem persists, contact your
local distributor or URIT.
1) Check the flow path tube. Reconnect or
replace the tube if necessary.
1) Flow path tube is leaky. 2) Check the magnetic valve and replace
Water drops adhere 2) Magnetic valve problem. it if necessary.
13
to the tip of probe. 3) The exterior of probe is 3) Check the exterior of probe. Clean or
dirty or scathed. replace the probe if necessary.
4) If the problem persists, contact your
local distributor or URIT.
1) Check if the reagent tray is sealed
completely.
2) Check if the heat dissipation device
works normally.
The cooling system is failed
Reagent tray cannot 3) Check if the refrigerants are used up.
14 or cooling temperature is not
be cooled. 4) Check if the circulation system of the
low enough.
cooling device works normally.
5) Replace the peltier.
6) If the problem persists, contact your
local distributor or URIT.

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1) Enter into system parameter” interface,

select “Engineer set” to adjust parameter.
(Only accessible to professional person
1) Instrument parameters are
authorized by URIT).
set improperly.
2) Read through the Operating Manual
2) Human carelessness, such
and avoid human mistake.
Probe and stirrer as reagent bottle lid is not
3) Do NOT put foreign objects on the
15 conflict with each opened.
operation panel.
other. 3) Put foreign objects on the
4) Check if the motor is installed and
operation panel.
works properly.
4) Motor problem.
5) Check the light coupling and replace it
5) Light coupling error.
if necessary.
6) If the problem persists, contact your
local distributor or URIT.

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CHAPTER 9 STORAGE AND TRANSPORTATION

9.1 Storage

The wrapped instrument should be stored at a ventilated room, with temperature range
from -40℃ to 55℃, ambient humidity not exceeding 95% and atmosphere pressure is
75kPa to 106kPa. DO NOT store the instrument along with any poison or corrosive. The
instrument stored for over one year may fall short of the precision of measurement.
Therefore, it is suggested that perform mechanical calibration and alignment procedure
when using the instrument.

CAUTION

Please contact URIT to perform calibration for mechanism of the instrument.

9.2 Transportation

The transportation must strictly follow the terms and conditions specified in the order
contract.

Do not ship the instrument along with any poison or corrosive.

CAUTION
Under the packing sound condition, the transport temperature is -40~55℃, the
relative Humidity is ≤95% and atmosphere pressure is 75kPa~106kPa.

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APPENDIX A REPLACEABLE COMPONENT

SN Name Remark
1 Fuse T8AL 250V
2 Reaction Cuvette
3 Reaction Cuvette Rack
4 Light Source Lamp 12V/20W
5 Teflon Tube ф1×2mm
6 PU Tube ф4×6mm, ф2×3mm, ф8×10mm
7 Aspirating Probe Reagent probe and sample probe
8 Step Motor
9 Vacuum Pump
10 Solenoid Valve
11 Temperature Controller
12 Temperature Sensor
13 Cooling fan

NOTE

Please use the replaceable component provided by URIT. Replacing the

components by service personnel who authorized by URIT. URIT is not
responsible for any consequences resulting from using parts or accessories not
specified by URIT.

NOTE

This replaceable component list just for reference. URIT reserves the right to
change the list without notice.

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