I

About this Manual

P/N: 01.54.457881
MPN: 01.54.457881015
Release Date: April, 2019
© Copyright EDAN INSTRUMENTS, INC. 2017-2019. All rights reserved
Statement
This manual will help you to better understand the operation and maintenance of the product. It
is reminded that the product should be used strictly in compliance with this manual. User
operation failing to comply with this manual may result in malfunction or accident for which
EDAN INSTRUMENTS, INC. (Hereinafter called EDAN) can’t be held liable.
EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any
materials contained in this manual shall not be photocopied, reproduced or translated into other
languages.
Materials protected by the copyright law, including but not limited to confidential information
such as technical information and patent information contained in this manual, shall not be
disclosed to any irrelevant third party.
The user shall understand that nothing in this manual grants him, expressly or implicitly, any
right or license to use any of the intellectual properties of EDAN.
EDAN holds the rights to modify, update, and ultimately explain this manual.
Responsibility of the Manufacturer
EDAN only considers itself responsible for any effect on safety, reliability and performance of
the equipment if:
Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by
persons authorized by EDAN, and
The electrical installation of the relevant environment complies with national standards, and
The instrument is used in accordance with the instructions for use.
Upon request, EDAN may provide necessary circuit diagrams, and other information to help
qualified technicians maintain and repair some parts, which EDAN may configure as user
serviceable.
Terms Used in this Manual
This guide is designed to give key concepts on safety precautions.
WARNING
A WARNING label advises against certain actions or situations that could result in personal
injury or death.
CAUTION
A CAUTION label advises against actions or situations that could damage equipment, produce
inaccurate data, or invalidate a procedure.
NOTE
A NOTE provides useful information regarding a function or a procedure

I
 A Table of Contents

Chapter 1 Safety Guidance ........................................................................................................... - 1 -

1.1 Indications for Use/Intended Use .......................................................................................... - 1 -
1.2 Warnings and Cautions .......................................................................................................... - 1 -
1.2.1 Safety Warnings .............................................................................................................. - 1 -
1.2.2 Safety Cautions ............................................................................................................... - 3 -
1.3 Symbols and Definitions ....................................................................................................... - 4 -

Chapter 2 General Overview ....................................................................................................... - 6 -

2.1 Introduction ............................................................................................................................ - 6 -
2.2 Main Parts ............................................................................................................................... - 7 -
2.2.1 Front cover....................................................................................................................... - 7 -
2.2.2 Fluidic part....................................................................................................................... - 7 -
2.2.3 Reagent area .................................................................................................................... - 8 -
2.2.4 Connection board ............................................................................................................ - 9 -
2.2.5 External power supply Adapter .................................................................................... - 10 -
2.2.6 Printer............................................................................................................................. - 10 -
2.2.7 External Barcode reader ............................................................................................... - 10 -
2.3 Configuration ....................................................................................................................... - 11 -
2.3.1 Standard Configuration ................................................................................................. - 11 -
2.3.2 Options ........................................................................................................................... - 11 -

Chapter 3 Measurement Principle ............................................................................................ - 12 -

3.1 WBC, RBC and PLT Measurement Principle.................................................................... - 12 -
3.2 Five-part Diff Measurement Principle ................................................................................ - 13 -
3.3 HGB Measurement Principle .............................................................................................. - 14 -
3.4 MCV and MPV Measurement ........................................................................................... - 14 -
3.5 Equations for Calculated Parameters .................................................................................. - 14 -
3.5.1 Calculation of WBC-Related Parameters .................................................................... - 14 -
3.5.2 Calculation of RBC-Related Parameters ..................................................................... - 15 -
3.5.3 Calculation of PLT-Related Parameters ...................................................................... - 15 -

Chapter 4 Installation Guidance ............................................................................................... - 17 -

4.1 Installation Environment ..................................................................................................... - 17 -
4.2 Unpacking............................................................................................................................. - 17 -
4.2.1 Unpacking Inspection ................................................................................................... - 17 -
4.2.2 Visual check .................................................................................................................. - 17 -
4.3 Installation ............................................................................................................................ - 18 -
4.4 User Login ............................................................................................................................ - 20 -

Chapter 5 Software Introduction .............................................................................................. - 21 -

-1-
 5.1 Toolbar Introduction ............................................................................................................ - 21 -
5.2 Common Buttons Introduction ............................................................................................ - 21 -
5.3 Software Screen Introduction .............................................................................................. - 22 -

Chapter 6 Reagents Management ............................................................................................. - 23 -

6.1 Diluent/ Lyse/Cleaner Management ................................................................................... - 23 -
6.2 Waste Management.............................................................................................................. - 24 -

Chapter 7 Startup ........................................................................................................................ - 25 -

Chapter 8 QC ................................................................................................................................ - 26 -
Chapter 9 Calibration ................................................................................................................. - 29 -

Chapter 10 Repeatability ............................................................................................................ - 31 -

Chapter 11 Sample Test .............................................................................................................. - 32 -
11.1 Sample Preparation ............................................................................................................ - 32 -
11.2 Run Sample ........................................................................................................................ - 32 -
11.3 Viewing Test Results ......................................................................................................... - 34 -
11.4 Searching Test Results....................................................................................................... - 34 -
11.5 Re-edit Patient Data ........................................................................................................... - 35 -

Chapter 12 Flags .......................................................................................................................... - 36 -

12.1 Results Flags ...................................................................................................................... - 36 -
12.2 System Alerts ..................................................................................................................... - 37 -
12.3 Morphologic Alarms .......................................................................................................... - 38 -
12.3.1 WBC Histogram Alarm .............................................................................................. - 38 -
12.3.2 RBC Histogram Alarm ............................................................................................... - 39 -
12.3.3 PLT Histogram Alarm ................................................................................................ - 40 -
12.3.4 WBC Scattergram Alarm............................................................................................ - 41 -
12.4 Pathological Alarms........................................................................................................... - 42 -
12.4.1WBC Pathological Alarms .......................................................................................... - 42 -
12.4.2 RBC Pathological Alarms .......................................................................................... - 43 -
12.4.3 PLT Pathological Alarms ........................................................................................... - 43 -

Chapter 13 Service ....................................................................................................................... - 44 -

13.1 System Initialization .......................................................................................................... - 44 -
13.2 Event Logs .......................................................................................................................... - 44 -
13.3 Error Logs........................................................................................................................... - 45 -
13.4 Backup & Restore .............................................................................................................. - 45 -
13.5 Settings ............................................................................................................................... - 45 -
13.5.1 Lab Parameters Setting ............................................................................................... - 46 -
13.5.2 Date/Time Setting ....................................................................................................... - 50 -
-2-
 13.5.3 Automatic Cycles Setting ........................................................................................... - 50 -
13.5.4 Printer Setting .............................................................................................................. - 51 -
13.5.5 Communication Setting .............................................................................................. - 52 -
13.5.6 Users Management Setting ......................................................................................... - 53 -
13.5.7 Software Update Management ................................................................................... - 54 -
13.6 Troubleshooting ................................................................................................................. - 55 -
13.6.1 Troubleshooting via Software .................................................................................... - 55 -
13.6.2 Parameters Troubleshooting ....................................................................................... - 58 -
13.6.3 Mechanical Problems Troubleshooting ..................................................................... - 59 -
13.7 Maintenance ....................................................................................................................... - 60 -
13.7.1 Automatic Bleach Cleaning Maintenance ................................................................. - 60 -
13.7.2 Regular Maintenance .................................................................................................. - 60 -
13.7.3 Cleaning and Disinfecting the Analyzer .................................................................... - 61 -

Chapter 14 Logout and Shutdown ............................................................................................ - 63 -

14.1 Logout ................................................................................................................................. - 63 -
14.2 Shutdown ............................................................................................................................ - 63 -

Chapter 15 Warranty and Service ............................................................................................ - 64 -

15.1 Warranty ............................................................................................................................. - 64 -
15.2 Contact Information ........................................................................................................... - 64 -

Appendix 1 Specifications ........................................................................................................... - 65 -

A1.1 Environment Requirements .............................................................................................. - 65 -
A1.2 Analyzer Specifications .................................................................................................... - 65 -
A1.3 Performance Specifications .............................................................................................. - 65 -
A1.4 Power Adapter ................................................................................................................... - 65 -

Appendix 2 Analytical Performance ......................................................................................... - 66 -

A2.1 Linear Range ..................................................................................................................... - 66 -
A2.2 Background ....................................................................................................................... - 66 -
A2.3 Precision ............................................................................................................................ - 66 -
A2.4 Carry-over.......................................................................................................................... - 66 -
A2.5 Accuracy ............................................................................................................................ - 67 -
A2.6 Measurement Range ......................................................................................................... - 67 -

Appendix 4 EMC Information ................................................................................................... - 68 -

Appendix 3 Safety Specifications ............................................................................................... - 71 -

Appendix 5 Glossary .................................................................................................................... - 72 -

Appendix 6 User Access .............................................................................................................. - 73 -

-3-
H50/H51 Hematology Analyzer User Manual Safety Guidance

Chapter 1 Safety Guidance

1.1 Indications for Use/Intended Use
H50/H51 Hematology Analyzer is intended to qualitatively and quantitatively measure blood
cells and provide measurement results. It is intended for some routine blood tests or physical
examination in outpatient department or ward of a hospital. H50/H51 Hematology Analyzer
supports to test whole blood samples. Human body fluid, human serum or plasma, and animal
blood are not tested by the analyzer.
The sample must be collected in a tube with K2 EDTA.
H50/H51 Hematology Analyzer should be operated by trained and qualified medical personnel.

1.2 Warnings and Cautions

1.2.1 Safety Warnings
NOTE:

The reliability of the analyzer and the safety of operators are considered during product
design and production. The following safety and preventive measures should be carried
out:

WARNING

Safety Warnings

1. The analyzer is not intended for treatment.

2. The analyzer is not intended for home use.
3. Do not use the analyzer if it is damaged or defective.
4. The analyzer should be installed by a qualified service engineer. Do not try to
access into the interior of the analyzer. Only authorized service personnel are
authorized to disassemble or maintain the analyzer.
5. To avoid electrical shock, never modify the analyzer’s AC power circuits.
6. The analyzer is intended for use only by trained technologists, nurses, physicians
and therapists. Operators should be familiar with the contents of this user manual
before operation.
7. The results given by the system should be examined based on the overall clinical
condition of the patient, and should not be a substitute for regular checking and
examination.
8. To ensure grounding reliability, only connect the system to a hospital-grade power
receptacle.

-1-
H50/H51 Hematology Analyzer User Manual Safety Guidance

WARNING

9. Connect the analyzer to a grounded socket and make certain that the power supply
meets the requirements specified in the user manual.
10. Do not exceed the maximum permitted load when using multiple portable socket-
outlets to supply the system.
11. SHOCK HAZARD - Do not attempt to connect or disconnect a power cord with wet
hands. Make certain that your hands are clean and dry before touching a power cord.
12. If you have any questions about the power adaptor or the power cord prior to using,
consult EDAN or its authorized distributors for service.
13. The analyzer is not waterproof. Do not use it in locations where water or any liquid
leakage may occur.
14. To avoid the possibility of electrostatic shock and damage to the system, avoid using
aerosol spray cleansers on the analyzer screen.
15. EXPLOSION HAZARD – The analyzer is not suitable for use in the presence of a
flammable anesthetic mixture with oxygen or other flammable compounds.
16. To avoid electrical shock, never use the system in altitude exceeding 3,000 meters
above sea level.
17. LASER RADIATION – The bar code scanner is a laser product. Do not view beam
generated by the scanner with eyes directly.
18. Periodically have the safety of the analyzer checked by a qualified service engineer.
19. Only accessories supplied or recommended by the manufacturer should be used.
Otherwise, performance and electric shock protection can‘t be guaranteed.
20. Blood samples should be collected according to proper medical guidelines which
contains collection details, such as selection of blood collection site, collection
procedures, sample handling, etc. Sterile techniques should be followed to prevent
the blood collection site from being contaminated.
21. Handle blood samples and collection devices with care, and wear approved
protective gloves to avoid direct contact with samples.
22. To avoid electrical shock and damage to the system, turn off the analyzer and
disconnect the analyzer from the AC power source before cleaning and disinfecting.
23. To avoid being injured, never touch the sampling needle directly with hands.
24. The system is for in vitro diagnostic use only.
25. Perform quality control (QC) tests to make sure that the system works smoothly.
26. The sample collection tube should only be used a single time.

27. The sample is contained in the sample tubes, so sample tubes need to be
disposed of as bio-hazardous waste, complying with local regulatory guidelines.

-2-
H50/H51 Hematology Analyzer User Manual Safety Guidance

WARNING

28. The analyzer needs to be disposed of according to local regulations after their useful
lives. Alternatively, they can be returned to the dealer or the manufacturer for
recycling or proper disposal. Please delete or back up safety data contained in the
analyzer before disposing of it.
29. Misuse of electrical equipment may cause electrocution, burns, fire and other
hazards.
30. Due to the use and the environment of this equipment, all parts and surfaces of
H50/H51 Analyzer are potentially infective. Wearing gloves when operating or
maintaining the analyzer and hands washing after work are essential.
31. Only reagents including Lyse, Cleaner, Diluent, Bleach, Hematology Controls and
Hematology Calibrator provided by EDAN or its authorized distributors should be
used. If other reagents are used, Edan will not assure the accuracy of test results
and will not be responsible for the analyzer’s maintenance and repair caused by the
reagents.
32. Don't position the analyzer in some places where it's difficult to disconnect the AC
plug.

1.2.2 Safety Cautions

CAUTION

1. Do not use the analyzer in a dusty environment with bad ventilation or in the
presence of corrosives.
2. Make sure that the time and date of the system are correct.
3. The system is intended to analyze whole blood samples. Never use it to analyze
serum or plasma.
4. If there are clots or bubbles in the blood sample, discard it and collect samples again.
5. Transport, store and use the analyzer, diluent, lyse, cleaner, Hematology Controls
and Hematology Calibrator according to the corresponding user manual.
6. Connect the analyzer with the peripherals recommended by EDAN.
7. Maintain the system as described in the user manual to avoid potential damage.
8. Do not clean the analyzer and accessories with abrasive fabric.
9. Do not immerse the analyzer into liquid under any circumstances.
10. Extreme humidity may affect test results. A relative humidity greater than 80% may
cause inaccurate results.
11. Use this system at a temperature between 18 °C and 32 °C. Outside this range, the
system may produce inaccurate results.
12. The cable tie must be removed before the analyzer is firstly turned on after
completion of its first installation. If not, the analyzer’s operation might be affected or
even worse the analyzer might be damaged.
-3-
H50/H51 Hematology Analyzer User Manual Safety Guidance

CAUTION

13. Make sure that there is no intense electromagnetic interference source around the
analyzer, such as radio transmitters, mobile phones etc. Attention: large medical
electrical equipment such as electrosurgical equipment, radiological equipment and
magnetic resonance imaging equipment is likely to bring electromagnetic
interference.

1.3 Symbols and Definitions

No. Symbol Description

1. Consult instructions for use

Warning, biological hazard

2. (Background color-yellow; symbol and outline-
black)

3. Recycle

4. On/Off button

5. Network port

6. Serial port

7. USB (Universal Serial Bus) connection

8. In vitro diagnostic medical device

9. Disposal Method

10. Manufacturer

11. Date of manufacture

12. Temperature limit

-4-
H50/H51 Hematology Analyzer User Manual Safety Guidance

13. Use-by Date

14. Serial number

15. Caution: Federal (U.S.) Law restricts this device to

sale by or on the order of a physician.

16. Equipotential grounding

17. Current: Direct

18. Warning
(Background: yellow Symbol and outline: black)

19. Batch code

20. Hand Crush/Pinch Point

(Background: yellow Symbol and outline: black)

21. Caution

The symbol indicates that the device complies with

22. the European Council Directive 98/79/EC
concerning medical devices.

-5-
H50/H51 Hematology Analyzer User Manual Measurement Principle

Chapter 2 General Overview

2.1 Introduction
H50/H51 Analyzer is an automated analyzer performing hematological analysis on whole blood
collected on tubes containing K2EDTA as anticoagulant. All parameters determined by the
analyzer are listed as follows:
White blood cell parameters: Determination
Symbol Description
WBC Total Count Measured
LYM%/# Lymphocyte percent and absolute value Measured/Calculated
MON%/# Monocyte percent and absolute value Measured/Calculated
NEU%/# Neutrophil percent and absolute value Measured/Calculated
EOS%/# Eosinophil percent and absolute value Measured/Calculated
BAS%/# Basophils percent and absolute value Measured/Calculated
ALY*(%/#) Abnormal Lymphocyte percent and absolute value Calculated
IMM*(%/#) Immature Monocyte percent and absolute value Calculated

Red blood cell parameters: Determination

Symbol Description
RBC Total count Measured
HGB Hemoglobin Measured
HCT Hematocrit Calculated
MCV Mean Cell Volume Measured
MCH Mean Cell Hemoglobin Calculated
MCHC Mean Cell Hemoglobin Concentration Calculated
RDW CV Red Blood Cells Distribution Width-CV Calculated
RDW SD Red Blood Cell Distribution Width-SD Calculated

Platelet parameters: Determination

Symbol Description
PLT Total count Measured
MPV Mean Platelet Volume Measured
PCT Platelet Hematocrit Calculated
PDW Platelets Distribution Width Calculated
PLCR Large Platelets Cell Ratio Calculated
PLCC Large Platelets Cell Count Calculated
NOTE:
9 Result is displayed and printed before the end of the analysis cycle.
9 Parameters followed with (*) are RUO (Research Use Only).

-6-
H50/H51 Hematology Analyzer User Manual Measurement Principle

2.2 Main Parts

H50/H51 Analyzer consists of front cover, fluidic part, reagent area, connection board, external
power supply adapter, printer (optional) and external Barcode reader.

2.2.1 Front cover

The front cover consists of the five elements listed below:
1. Touch and display screen (10.4”)
2. ON/OFF button
3. Start key
4. USB port connection

2.2.2 Fluidic part

The fluidic part is located on the right side of the instrument directly accessible after opening of
the fluidic door. The fluidic part consists of the six elements listed below:
1. Sampling module
2. Syringe module
3. Syringe valve module
4. Counting module
5. Counting valve module
6. Optic Bench

-7-
H50/H51 Hematology Analyzer User Manual Measurement Principle

1
3

2.2.3 Reagent area

The reagent area is located on the left side of the instrument directly accessible after opening of
the reagent door. The reagent area is dedicated for lyse & cleaner reagents.

-8-
H50/H51 Hematology Analyzer User Manual Measurement Principle

2.2.4 Connection board

The connection board is located at the back of the instrument and allows different types of
connections described below.

4 USB Ports

TCP/IP Port

Serial Link RS232

Not Used
P/S 24V

-9-
H50/H51 Hematology Analyzer User Manual Measurement Principle

2.2.5 External power supply Adapter

H50/H51 Analyzer is supplied with an external power supply adapter.

100-240 VAC; 50/60 Hz; Single phase with ground

NOTE:

If the power cord provided with the instrument needs to be replaced, the new cord must
be in compliance with the local regulation and the instrument specification in matter of
consumption.

2.2.6 Printer
H50/H51 Analyzer is not delivered with the printer. The instrument is equipped already with
PCL3 & PCL6 standard printer drivers which cover a large selection of printer models, such as
HP Laserjet Professional P1106.

2.2.7 External Barcode reader

An external barcode reader (model OPTICON - C37) can be connected to an USB port of
H50/H51 Analyzer. It only allows entering the following information automatically:
¾ Sample identification SID
¾ Reagent identification (LYSE, CLEANER and DILUENT)
¾ QC and calibration lot number

- 10 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

2.3 Configuration

2.3.1 Standard Configuration

x 1 analyzer
x 1 power cord
x 1 power supply adapter
x 1 flat screwdriver
x 1 user manual
x 1 certificate of approval
x 1 diluent pick up tubing
x 1 waste tubing
x 1 waste container (10L)
x 1 quick reference card
x 1 USB Barcode Reader
x 1 Packing List

2.3.2 Options
x 1 USB Printer
x 1 USB Keyboard

NOTE:

The following table lists the differences between H50 Hematology Analyzer and H51
Hematology Analyzer.

Model USB Keyboard Software (English Version) Software (Other Languages)

H50 Optional Standard Optional

H51 Not Applicable Standard Optional

- 11 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

Chapter 3 Measurement Principle

3.1 WBC, RBC and PLT Measurement Principle
In accordance with electrical impedance method based on Coulter Principle, WBC total counts is
measured in the WBC counting chamber , RBC total counts and PLT total counts in the RBC
counting chamber. This method is based on the modification of the impedance of a calibrated
aperture soaking in an electrolyte and going through a constant current delivered by two
electrodes located on both sides of the aperture. A vacuum applied on a side of the aperture
allows the cells passage. Cells oppose their physical volume to the current passage. A voltage
impulse is registered at the electrodes terminal. The height of this impulse is proportional to the
cell volume.

- 12 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

3.2 Five-part Diff Measurement Principle

The principle of this technology is based on the introduction of the sample solution and a
sheathing liquid (Diluent) at the same in the flow cell. Thus, the sheathing liquid drives the
sample flow straight across the cuvette through the detection area.
The main advantages of the measurement principle are:
1) High level of reliability of the optical adjustment
2) Only two measurement axes for five parameters
3) High resolution matrix
4) Low level of contamination between two measurements
5) Low Reagents consumption


WBC 5 differential percentages are obtained by optic measurements. The measured pulses on the
two optical channels are displayed on DIF Plot ALL (Y axis) and FSC (X axis). Each dot on the
DIF Plot represents the height in ALL and FSC of at least one pulse.

- 13 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

3.3 HGB Measurement Principle

The HGB measurement is directly done in the WBC
chamber, by spectrophotometer (545 nm). HGB is
detected by formation of oxyhemoglobin.
HGB blank check is performed at each STARTUP
cycle. HGB Blank measurement is done also at the
beginning of each analysis cycle. By comparison of
the two values, it is possible to follow potential
evolution of the blank value in order to warn the user
if necessary.

3.4 MCV and MPV Measurement

MCV is the average volume of individual erythrocytes. Based on RBC histogram, the analyzer
measure MCV directly.
MPV is the average volume of individual platelets. Based on PLT histogram, the analyzer
measure MPV directly.

3.5 Equations for Calculated Parameters

3.5.1 Calculation of WBC-Related Parameters
1) Lymphocyte absolute value (LYM#) is made from LYM% and WBC total counts by formula
below:
LYM# = LYM% š WBC (total counts)
2) Monocyte absolute value (MON#) is made from MON% and WBC total counts by formula
below:
MON# = MON% š WBC (total counts)
3) Neutrophil absolute value (NEU#) is made from NEU% and WBC total counts by formula
below:
NEU# = NEU% š WBC (total counts)
4) Eosinophil absolute value (EOS#) is made from EOS% and WBC total counts by formula
below:
EOS# = EOS% š WBC (total counts)
5) Basophils absolute value (BAS#) is made from BAS% and WBC total counts by formula
below:
BAS# = BAS% š WBC (total counts)
6) ALY% is the percentage of the LYM based on a fixed threshold in the lymphocyte’s
population area

- 14 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

7) Abnormal lymphocyte absolute value (ALY#) is made from ALY% and lymphocyte absolute
value by formula below:
ALY# = ALY% x LYM#
8) IMM% is the number of elements in the IMM population area divided by sum of elements
in DIF scattergram including IMM
9) Immature monocyte absolute value (IMM#) is made from IMM% and WBC total counts by
formula below:
IMM# = IMM% x WBC (total counts)

3.5.2 Calculation of RBC-Related Parameters

1) Hematocrit (HCT) is measured by integration of the volume of the red blood cells which
flow in the RBC counting chamber aperture.
ୖ୆େ୶୑େ୚
HCT=
ଵ଴

Where HCT is expressed in %, RBC is expressed in 1012/L and MCV is expressed in fL.
ʹሻ Mean Corpuscular Hemoglobin (MCH) calculation is obtained from HGB and RBC by the
following formula 
ୌୋ୆
MCH =
ୖ୆େ

Where MCH is expressed in pg, HGB is expressed in g/L and RBC is expressed in 10 12/L.
3) Mean Corpuscular Hemoglobin Concentration (MCHC) is made from HGB and HCT by the
formula below:
ୌୋ୆୶ଵ଴଴
MCHC = 
ୌେ୘

Where MCHC is expressed in g/L, HGB is expressed in g/L and HCT is expressed in %.
4) RDW CV parameter is derived from the RBC histogram.
5) RDW SD parameter is calculated on curve distribution (defined as curve width at 20% of
peak)

3.5.3 Calculation of PLT-Related Parameters

1) Thrombocrit (PCT) is made from PLT and MPV by formula below:
୔୐୘୶୑୔୚
PCT =
ଵ଴଴଴଴

Where PCT is expressed in %, PLT is expressed in 10 9/L and MPV is expressed in fL.

- 15 -
H50/H51 Hematology Analyzer User Manual Measurement Principle

2) PLCR (Platelet Large Cell Ratio) indicates the percentage of large platelets with a
volume >12 fL. Aside from the two flexible discriminators which delimit the volume
distribution curve, there is additionally a fixed discriminator at 12 fL (marked in red on
below picture). The PLCR is the percentage of cells higher than 12fL regarding the whole
platelets count.
PLCR is significantly decreased in patients with thrombocytosis while it is increased in
thrombocytopenia. In patients with high counts, PLCR is significantly decreased in reactive
thrombocytosis than neoplastic thrombocytosis. PLCR is more likely higher in destructive
thrombocytopenia than hypo-proliferative thrombocytopenia. PLCR is inversely related to
platelet count and directly related to PDW and MPV.

3) Large platelets cell count (PLCC) is made from PLCR and PLT by formula below:
PLCC = PLCR x PLT
Where PLCC is expressed in 109/L, PLCR is expressed in % and PLT is expressed in 10 9/L.
4) PDW means the size distribution spread of the platelets population derived from the PLT
histogram.

- 16 -
H50/H51 Hematology Analyzer User Manual Installation Guidance

Chapter 4 Installation Guidance

4.1 Installation Environment
To ensure H50/H51 Analyzer fulfill its function, it must be installed on a strong and stable table
which can support the weight of the analyzer as well as one printer, one barcode reader and
reagents. Enough space at the rear of the instrument and enough space on each side are required
for analyzer’s maintenance, reagents installation and disconnection of power cord. Exposure to
direct sunlight shall be avoided.
9 Indoor use
9 Altitude is no more than 3000 meters.
9 Work temperature: 18 °C to 32 °C
9 Maximum relative humidity when temperatures is 32 °C is 80 %, decreasing linearly to 50 %
at 40 °C.
9 Main power supply voltage fluctuations up to ±10 % of the nominal voltage.
9 Transient over voltages typically present on the main supply.
9 Rated pollution degree II.
NOTE:
9 If the ambient temperature moves more than 10°C during the working day, H50/H51
Analyzer must be calibrated more frequently.
9 If H50/H51 Analyzer is used under other conditions than the one described above,
contact your distributor.
9 If H50/H51 Analyzer has been stored at a temperature less than 10°C, it must stay
at room temperature for 24 hours to let all parts to reach the ambient temperature
before switching it on.

4.2 Unpacking

4.2.1 Unpacking Inspection

H50/H51 Analyzer is delivered in a cardboard. It is recommended to examine the package
visually before unpacking. If there is any sign of mishandling, damage or else, contact the carrier
to claim for damage. During device unpacking, the technical person who takes charge of the
installation must ensure the good presence of all elements compared with the Packing List.

NOTE:
If any part is missing, contact your distributor immediately.

4.2.2 Visual check

Open the fluidic door on the right side with the screw driver provided in the kit and check the
following items:
Ö Syringes pistons located in top position

- 17 -
H50/H51 Hematology Analyzer User Manual Installation Guidance

Ö Sampling module located on front

Ö Needle rinsing dismountable system well locked on the sampling module.

4.3 Installation
Installation of the device must be done according to the procedures described below.

1. Remove the instrument from the cardboard and place it on a stable table.
2. Remove the accessory boxes from the reagent compartment and unpack them.

- 18 -
H50/H51 Hematology Analyzer User Manual Installation Guidance

3. Connect one end of the diluent pickup tubing to the white diluent connector located at the
back of the instrument and connect another end to the diluent container.
NOTE:
Diluent container must be placed on the same level as the instrument.

Connect the diluent pickup tubing

and turn clockwise the pickup tube.

4. Connect one end of the waste pickup tubing to the red waste connector located at the back of
the instrument and put another end into a waste container.
NOTE:
Waste container must be placed on the floor.

To connect the waste tubing and

turn anticlockwise the waste tubing

5. Tighten the cap of the Lyse pickup tubing (Yellow color sleeve) and the cap of the Cleaner
pickup tubing (Blue sleeve) to the corresponding bottles. Install lyse and cleaner bottles in the
reagent compartment of the instrument.

- 19 -
H50/H51 Hematology Analyzer User Manual Installation Guidance

6. Connect one end of the power supply cable to the power supply adapter and connect the other
end of the power supply cable to the instrument. The connection way is shown below.

7. Plug the main cord to the main power supply. 100-240 VAC; 50/60 Hz; Single phase with
ground

4.4 User Login

Press On/Off button to enter into the Login Screen. Enter operator ID and password, and press Login to
enter into Run Sample Screen.
2 levels of access: Administrator and
Operator. Operator has limited
accesses compared with Administrator.
Please refer to Appendix 6 for detailed
information.
Regarding the first login, only
Administrator can log in. Thereafter,
Operator access level can be created
and password can be changed.
 Administrator: Operator ID = ADMIN,
Password = 123456

NOTE:
In order to assure data safety contained in the analyzer, the user can change the
password (123456) provided by the manufacture after first login in accordance with the
procedures described in Section 13.5.6 User Management Setting.

- 20 -
H50/H51 Hematology Analyzer User Manual Reagents Management

Chapter 5 Software Introduction

5.1 Toolbar Introduction
All menus and sub-menus are displayed with the same toolbar as described below.


‹ PREVIOUS: Allow to return to the previous screen except when the system in under the
Main Screen.
‹ TOOLS: Depending on the screen, you can access to some of the following options.

To send results data to the host computer 

 To print data  To delete data 

To save data To cancel the pop-out

‹ MENU: Allow to return to Main Screen except when the system in under the Main Screen.

‹ ABOUT: Allow accessing to the following screen to know about the analyzer’s information.

5.2 Common Buttons Introduction

The following buttons often appear in different screens but they have the same functions.
Therefore, these buttons and their functions are listed here only once. When the software screens
are detailed in other chapters, these buttons’ functions will not repeated.

Move to the top of the table Move to the left of the table

Move up in the table step by step Move to the left step by step

Move down in the table step by step Move to the right of the table

Move to the right step by step

Move to the bottom of the table
If On/Off Button is red, the current cycle is unfinished.
Validate changes
If On/Off Button is green, a new cycle can be started.
Cancel changes

- 21 -
H50/H51 Hematology Analyzer User Manual Reagents Management

5.3 Software Screen Introduction

After user login, the system directly enters into Run Sample Screen. Press Menu to enter into
Main Screen.
From the main screen, users can access to the
following sub-screens in accordance with
actual needs.

z RUN SAMPLE z STARTUP

z RESULTS z QC SCREEN

z REAGENTS z REPEATABILITY

z SERVICE z CALIBRATION

z LOG OUT z SHUT DOWN

Main Screen

Users can access into different sub-screens from the main screen by pressing the corresponding
buttons. Each sub-screen has the detailed introduction in its corresponding chapter.

Sub-screens Chapter
RUN SAMPLE Chapter 11
RESULTS Chapter 11
REAGENTS Chapter 6
SERVICE Chapter 13
STARTUP Chapter 7
QC SCREEN Chapter 8
REPEATABILITY Chapter 10
CALIBRATION Chapter 9
LOG OUT Chapter 14
SHUT DOWN Chapter 14

- 22 -
H50/H51 Hematology Analyzer User Manual Reagents Management

Chapter 6 Reagents Management

6.1 Diluent/ Lyse/Cleaner Management
Procedures for Diluent management are as follows:
1) Press Reagents to enter into Screen 5-1.
2) Press Diluent to enter into Screen 5-2.
3) Enter Diluent’s lot, expiry, capacity, serial and code in Screen 5-2.

4) Press t finish Diluent’s management and return to Screen 5-1.

to
5) Press Prime to prime diluent.
NOTE:
9 Procedures for Cleaner and Lyse management are identical with procedures of
Diluent’s management.
9 When the three regents are installed simultaneously, Prime All is required.
9 All reagents including cleaner, diluent and lyse supplied by EDAN are cyanide-free.


Screen 5-1 Screen 5-2

- 23 -
H50/H51 Hematology Analyzer User Manual Reagents Management

Cycles Counter Reagents Log

 
 Press Cycles Counter on Screen 5-1 to Press Reagents Log on Screen 5-1 to enter
 enter into the Screen. Operator and into the Screen. Users can view reagents
 Administrator can view information on this information on this screen.
 screen but only Technician is allowed to
 perform Reset operation.

6.2 Waste Management

Press Waste on Screen 5-1 to enter into Screen 5-3.
Two ways to dispose waste:
1) Waste Container: If the customer use
waste container instead of waste drainage
to collect waste, the Waste Capacity needs
to be entered, then click “Reset” and press

.
2) Waste Drainage: If the customer uses the
waste drainage instead waste container to
treat the waste, directly select Waste Open
Drain.
Screen 5-3
NOTE:
If select Waste Open Drain, Waste Capacity and Reset will be removed from the
screen.

- 24 -
H50/H51 Hematology Analyzer User Manual Startup

Chapter 7 Startup
Press to turn on the analyzer and the
system will automatically do STARTUP. After
Startup, the system will enter into Login
Screen. After login, the system directly enters
into Run Sample Screen to display the
STARTUP results.

Run Sample Screen

Startup cycle is dedicated to daily check the
background values of measured parameters. It must
be launched every day before QC and then before
patient’s analysis.

Before user login, the system will automatically

finish background tests. After login, the system
directly enters into Run Sample Screen. Operator
can check the background test results on this screen.

Parameter Background If the test results don’t meet requirements, the

system will hint operator to re-do Startup
WBC ʇ0.2 x109/L cycle by the message “STARTUP FAILED –
RBC ʇ 0.02 x1012/L BACKGROUD CHECK FAILED”.
HGB ʇ 1 g/L If the operator runs sample test after a failed
PLT ʇ 10 x109/L startup, all results will be displayed and printed
with the indication “Startup failed”

- 25 -
H50/H51 Hematology Analyzer User Manual QC

Chapter 8 QC
To control the stability of the instrument before running patient samples, it is mandatory to run
QC test at the beginning of the working day. If the QC test results are out of control, it is
recommended to perform a calibration, then run QC test again.
NOTE:

Take safety measures when working with biological samples, such as wearing
approved gloves, etc.
Only controls provided by EDAN or its authorized distributors can be used. If not, Edan
is not responsible for any adverse consequences such as test results’ accuracy,
analyzer’s troubleshooting, maintenance and repair, etc.
Press QC to enter into Screen 7-1. Press Changes to enter into Screen 7-2. Press Results to enter
into Screen 7-3.
“CHANGE” button allows creating a new QC
lot or re-editing the existent QC information.
But all its associated results will be deleted if
you re-edit the existent QC information.

You can directly go to “RESULTS” to do QC

test or view QC test results. The sampling
needle will move down to the sampling
position automatically. Present controls under
the sampling needle and press the trigger, the
analyzer will automatically do the sample
Screen 7-1
aspiration and analysis, and finally display the
test results on the screen.

The Screen 7-2 is mainly used to edit control

material’s information.
Two ways to edit Lot, Level, Expiry, Targets
and Limits on the Screen 7-2:
‹ Enter manually by Alpha-Numeric touch
screen keyboard
‹ Import the information from USB drive
with the button “LOAD”

Screen 7-2

- 26 -
H50/H51 Hematology Analyzer User Manual QC

The Screen 7-3 is mainly used to perform

QC test and view the test results.
Under the screen, the sampling needle will
move down to aspirate the prepared QC
materials by pushing the start key and then
the system will automatically finish the
whole analysis and display the test results
on the screen.

Screen 7-3
QC results can be viewed in Table mode as displayed in Screen 7-3. But the results can also be
viewed in Details mode by pressing “DETAILS” to enter into Screen 7-4 or in LJ Graphs mode
by pressing “LJ GRAPHS” to enter into Screen 7-5.

These pictures can be enlarged respectively

by pressing them.

Screen 7-4

Take WBC for instance to explain how to interpret the

LJ GRAPHS:
High Limit

High Limit
Target Target
Low Limit

Test result Low Limit Yellow Line

NOTE:
The position of yellow line represents a QC test.
Screen 7-5 Therefore the test result varies as the yellow
line’s position changes.

- 27 -
H50/H51 Hematology Analyzer User Manual QC

The system will indicate whether the result of each parameter is outside the limits with H/L. If
the results of some parameters are outside the acceptable ranges, check the following items:
z Refer to the user manual to confirm that the test procedures are correct.
z Controls are stored properly and don’t expire.
z The system passes the STARTUP.
z If the QC test fails, conduct sample test with the sample which must have been tested
yesterday after the analyzer’s QC test succeeds and then observe whether there are some
differences between the test results obtained today and the results obtained yesterday. If
there is no difference, please contact Edan’s service engineer. If there is difference, it
means the analyzer might need to be calibrated. Please do the calibration and then re-
conduct QC test. If the QC test still fails, please contact Edan’s service engineer.
z If the QC test fails, re-conduct QC test with the previous lot of controls. Contact Edan’s
service engineer if the QC test with the previous lot of controls succeeds. Calibrate the
analyzer if the QC test with the previous lot of controls still fails. Re-conduct QC test
after calibration. If the QC test still fails after the analyzer’s calibration, please contact
Edan’s service engineer.
z It is recommended to perform instrument calibration if at least one of parameters is out
of limits from a significant degree.
NOTE:
1) Concerning Controls’ usage, storage, handling and other details, please strictly
respect its user manual.
2) Perform QC tests every day before sample analysis. If not, all results will be
displayed and printed with the indication “QC not done”.
3) If QC test fails, all results will be displayed the indication “QC FAILED” unless a new
QC test succeeds.
4) The analyzer can keep 100 results (results and histograms) per lot for 12 different
lots.
5) The column allows selecting or unselecting a result in the table. Mean, SD and
CV are only decided by the selected results ( ) in the table. Automatic calculations
will be implemented accordingly.

- 28 -
H50/H51 Hematology Analyzer User Manual Calibration

Chapter 9 Calibration
The H50/H51 Hematology Analyzer has been calibrated prior to delivery. However, errors may
still be introduced to the system during transport or installation. To maintain the accuracy and
precision of this analyzer, Edan recommends that QC test needs to be conducted prior to being
used for sample analysis for the first time and after every repair and maintenance of the analyzer.
If the QC test fails, which is not caused by the improper operation or the controls, the analyzer
needs to be calibrated.
NOTE:
Only the calibration materials provided by EDAN or its authorized distributors should be
used.
Press Calibration to enter into Screen 8-1. Press Change to enter into Screen 8-2. Press Results
to enter into Screen 8-3.
“CHANGE” button allows editing new calibration
information or re-editing the existent calibration
information. But all its associated results will be
deleted if you re-edit the existent calibration
information.

You can directly go to “RESULTS” to do

calibration test or view calibration test results. The
sampling needle will move down to the sampling
position automatically. Present calibration
materials under the sampling needle and press the
Screen 8-1
start key, the analyzer will automatically do the
sample aspiration and analysis, and finally display
the test results on the screen.

The Screen 8-2 is mainly used to edit

calibration material’s information.

Two ways to edit Lot, Expiry, Targets and

Limits on the Screen 8-2:

‹ Enter manually by Alpha-Numeric touch

screen keyboard

‹ Import the information from USB drive

 with the button “LOAD”
Screen 8-2

- 29 -
H50/H51 Hematology Analyzer User Manual Calibration

The Screen 8-3 is mainly used to perform

calibration test and view the test results.

Under the screen, the sampling needle will

move down to aspirate the prepared
calibration materials by pushing the start key
and then the system will automatically finish
the whole analysis and display the test results
on the screen.
After tests, press Calibrate and the Screen 8-4
pops out. Unselect parameter(s) you do not
Screen 8-3

want to calibrate. Press to finish

calibration. Finally the coefficients will be
updated on Screen 8-1.

Screen 8-4
Press on to restart the calibration

NOTE:
1. 3 calibration tests at least and 12 calibration tests at most are required to be
conducted successively.
2. The column allows selecting or unselecting a result in the table. Mean, SD and
CV are only decided by the selected results ( ) in the table. Automatic calculations
will be implemented accordingly.
3. Concerning calibration materials’ usage, storage, handling and other details, please
strictly respect its user manual.
4. If the room temperature changes more than 10°C during the working day, the
instrument must be calibrated more frequently.

- 30 -
H50/H51 Hematology Analyzer User Manual Repeatability

Chapter 10 Repeatability
Press Repeatability to enter into Screen 9-1. Press Details to enter into Screen 9-2.
Under the Screen 9-1, the sampling needle will
move down to aspirate the prepared materials
by pushing the start key and then the system
will automatically finish the whole analysis
and display the test results on the screen.

The test results can be viewed in Table mode

as displayed in Screen 9-1 or be viewed in
Details mode by pressing “DETAILS” to enter
into Screen 9-2.

Screen 9-1

These pictures can be enlarged respectively

by pressing them.

Screen 9-2
NOTE:
1) 3 repeatability tests at least and 50 repeatability tests at most are required to be
conducted successively.
2) The column allows selecting or unselecting a result in the table. Mean, SD and
CV are only decided by the selected results ( ) in the table. Automatic calculations
will be implemented accordingly.

3) The button allows deleting the unselected result(s).

- 31 -
H50/H51 Hematology Analyzer User Manual Sample Test

Chapter 11 Sample Test

11.1 Sample Preparation
The sufficient human blood sample must be collected in a K2 EDTA tube and it must be properly
homogenized before analysis.
Please conduct sample tests immediately after sample collection. If the sample needs to be stored,

it needs to be stored at 2-8ć for no more than 24 hours. If the sample has been stored at 2-8ȭ, it

needs to be equilibrated at room temperature for ten minutes before use.

11.2 Run Sample

Press Run Sample to enter into Screen10-1 and press Next Sample to enter into Screen10-3.

The Screen 10-1 is mainly used to test samples

and view test results.
The sample’s information needs to be edited
on Screen 10-3 prior to sample test. After the
completion of sample’s information, the
system will return back to the Screen 10-1 and
all the sample’s information will be displayed
on the left side of the screen.

Screen 10-1

Under the Screen 10-1, the sampling needle will move down for aspirating the prepared sample.
The system will finish the whole sample test automatically and finally display test results on the
screen.
A mode button is located on the Screen 10-1.
Press the mode button, the system will pop
out Screen 10-2.

Users can select the sample type and the

analysis mode in accordance with the actual

needs and press , then the mode button

will be changed into what you have selected.
Meanwhile, this can also be set up on the
Screen 10-3.
Screen 10-2
- 32 -
H50/H51 Hematology Analyzer User Manual Sample Test

The Screen 10-3 is used to edit sample’s

information. After editing the following
information, the system will go back to the
Screen 10-1 for sample test.


Screen 10-3
The operator can edit the following information in Screen 10-3.
1. NAME: Patient name (1-20 characters)
2. PID: Patient identification (1-16 characters)
3. SID: Sample identification(1-16 characters)
4. Birth Date: patient’s birth date
5. Doctor: Doctor ID or doctor’s name (1-16 characters)
6. Comments: Add comments if needed
7. Gender: F(female)/M(male)/U(unknown)
8. Group: Reference Range
9. Mode: DIF WB, DIF PD, CBC WB, CBC PD, DIF CAP, CBC CAP
NOTE:
1) WB stands for whole blood and PD stands for pre-dilution. If PD mode is selected,
the button “DIL DISPENSE” will appear on the Screen 10-1. Press the button and
the system will dispense 300μL dilution via the sampling needle in to the prepared
tube.
2) If the sampling needle is not down in sampling position, press on start key and
needle will go down in sampling position

Start key

- 33 -
H50/H51 Hematology Analyzer User Manual Sample Test

3) Two thirds of the sampling needle shall be within the blood sample to ensure the
successful sample aspiration and then press on start key.

two-thirds of
the needle Blood volume
inside

4) During sample aspiration, ON/Off button will blink. The system will beep after
completion of sample aspiration, then the sampling needle will move up and the
sample tube can be removed.
5) As soon as the cycle is launched, the SID is incremented automatically.

11.3 Viewing Test Results

Press Results to enter into Screen 10-4. The test results can be viewed in Table mode as
displayed in Screen 10-4. The test results can also be viewed in Details mode as displayed in
Screen 10-5. Firstly select one of the test results on Screen 10-4 that you want to view in Details
mode and then press Details on Screen 10-4.



Screen 10-4 Screen 10-5

11.4 Searching Test Results

Press Results to enter into Screen 10-4. Press Date in Screen 10-4 to enter into Screen 10-6.
1) Select Year-Month, Day and TIME/SID in Screen 10-6
2) Press DETAILS on Screen 10-6, you will be viewed the selected test results in Details mode.
- 34 -
H50/H51 Hematology Analyzer User Manual Sample Test

3) Press TABLE VIEW in Screen 10-6, you will be viewed the selected test results in Table
mode.

Screen 10-4 Screen 10-6

11.5 Re-edit Patient Data

The patient’s information can be re-edited if
any error is found.

Press “Edit Patient Data” in Screen 10-5 or

“Edit” on Screen 10-4, and the system will
enter into Screen 10-7.

Re-edit the patient’s information on the Screen

10-7 in accordance with actual needs and press

to save changes.

After changes, the new patient’s information

Screen 10-7
will be updated on the Screen 10-5.

- 35 -
H50/H51 Hematology Analyzer User Manual Test Results

Chapter 12 Flags
Results flags are
displayed behind the
test values.

These histograms and

scattergram can be
enlarged respectively
by pressing them.

This is the flag box.

The system alerts and
the morphological
alarms are displayed
in the flag box.
12.1 Results Flags
Results flags are directly displayed behind the test values and they will be printed out together
with the test results. The following table lists all results flags which may appear on the test results.

Symbol Interpretation Note

* Inconsistent data between count periods Result is displayed in bold

The test result is above the linearity range but within

+ Result is displayed in bold
the measurement range.

++++ The measured result is above the measurement range. Result is replaced by ++++

An alarm is associated with the parameter and the

͠ Result is displayed in italic.
alarm is displayed in the flag box.

h or l: result is colored in
The test result is above or below the corresponding
light orange
H/h/L/l “Reference Ranges” as the Reference Ranges Screen
H or L: result is colored in
in Section 12.5.1.5 Reference Ranges shows.
red

- 36 -
H50/H51 Hematology Analyzer User Manual Test Results

12.2 System Alerts

The system alerts have the corresponding

abbreviations. The abbreviations are
displayed in the flag box. Press the
abbreviations, an enlarged flag box will
pop out to display its detailed information
as the left Screen shows.

The following Table 11-1 lists all the

system alerts and its corresponding
abbreviations.
 

Table 11-1

Detailed information in
System Alerts Triggers
pop-out window
Background test results don’t meet
S-UP Failed Startup Failed
background requirements.
Means that the Instrument temperature is
INS-T Instrument temperature out
lower than 18°C or higher than 32°C and the
of range
test results may be affected.
QC Not Done During the
QC NOT DONE QC tests are not done during the day.
Day

QC FAILED QC Failed on last run The last QC test failed.

Clog detected during RBC or PLT

RBC Clog RBC Aperture Clog
measurement (aperture clog).
Clog detected during WBC measurement
WBC Clog WBC Aperture Clog
(aperture clog).
Unbalanced counting between the resistive
and the optical measurement on the WBC
Channel. This may be explained by a clog on
the WBC aperture, a clog on the WBC flow
WBC-BAL WBC Balance cell or that the stop cock has been left as
closed.
NOTE:
It will trigger an automatic rinsing cycle
called “APERTURES RINSING”

- 37 -
H50/H51 Hematology Analyzer User Manual Test Results

Unstable LED light low measurement during

WBC DIF measurement. This may come from
DIF DEFAULT DIF Optical Default
bubble or unexpected phenomenon during
WBC DIF measurement.

12.3 Morphologic Alarms

Morphologic alarms are related to cells

characterization. The morphologic alarms
have the corresponding codes. The codes
are displayed in the flag box. Press the
codes, an enlarged flag box will pop out
to display the detailed messages of the
morphologic alarms as the left Screen
shows.

Press SERVICE/SETTINGS/LAB
PARAMETERS/CBC THRESHOLDS
AND FLAGS and the system will enter
into Screen11-1 as the left screen shows.
Morphologic alarms will be affected if the
thresholds displayed in the left screen are
changed. Therefore, only technical
persons are recommended to edit values
on this screen.

Screen 11-1

12.3.1 WBC Histogram Alarm

Morpho Alarms Detailed information in pop-out window Causes

Presence of platelet aggregate,

WBC - L1 WBC - L1 : Small Lymphocytes erythroblast or small
lymphocytes at the left of L1.

Presence of immature cells at

WBC – L5 WBC – L5 : Immature Cells
the right of L5.

- 38 -
H50/H51 Hematology Analyzer User Manual Test Results

Counts

fL


1) The alarm WBC - L1 will be triggered if this population at the left of L1 is higher than an
absolute limit AND a percentage of the LYM.
2) The alarm WBC – L5 will be triggered if this population at the right of L5 is higher than an
absolute limit AND a percentage of the WBC.
NOTE:
9 First peak on the left side of the histogram represents the lymphocytes cells; the
other one located on the right side represents all the others WBC populations.
9 Only technical persons are recommended to edit thresholds (L1 and L5) and flags in
Screen 11-1 because any change might trigger or affect the alarm WBC - L1 and
WBC – L5.

12.3.2 RBC Histogram Alarm

Morpho Alarms Detailed information in pop-out window Causes

Abnormal quantity of
RBC - Micro RBC – R1: Microcytes microcytes at the left side of
CR1.
Abnormal quantity of
RBC - Macro RBC – R2: Macrocytes macrocytes at the right side of
CR2.
Counts

CR1 CR2

fL
1) The alarm RBC - Micro will be triggered if this population at the left of CR1 is higher than
an absolute limit OR a percentage of the RBC.
2) The alarm RBC - Macro will be triggered if this population at the right of CR2 is higher than

- 39 -
H50/H51 Hematology Analyzer User Manual Test Results

an absolute limit OR a percentage of the RBC.

NOTE:
Only technical persons are recommended to edit thresholds (CR1 and CR5) and flags in Screen
11-1 because any change might trigger or affect the alarm RBC - Micro and RBC - Macro.

12.3.3 PLT Histogram Alarm

Morpho Alarms Detailed information in pop-out window Triggers

Presence of abnormal quantity
PLT - Debris PLT - Debris
of debris or small cells.
PLT - Schizo PLT - Schizo Presence of schizocytes.
PLT - Micro PLT - Micro Presence of microcytes.

Counts

fL

1) The alarm PLT - Debris will be triggered if this population at the left of CP1 is higher than
an absolute limit OR a percentage of the PLT.
2) The alarm PLT - Schizo will be triggered if this population between CP2 and P is higher than
an absolute limit OR a percentage of the PLT.
3) The alarm PLT - Micro will be triggered if this population defined by CP3-2 width at the
right of CP3 is higher than an absolute limit AND a percentage of the PLT.
NOTE:
Only technical persons are recommended to edit thresholds (P, PL, CP1, CP2, CP3 and CP3-2)
and flags in Screen 11-1 because any change might trigger or affect the alarm PLT – Debris,
PLT - Schizo and PLT - Micro.

- 40 -
H50/H51 Hematology Analyzer User Manual Test Results

12.3.4 WBC Scattergram Alarm

Press SERVICE/SETTINGS/LAB
PARAMETERS/DIF FLAGS and the
system will enter into Screen11-2 as the left
screen shows. The following morphologic
alarms will be affected if the values
displayed in the left screen are changed.
Therefore, only technical persons are
recommended to edit values on this screen.

Screen11-2

Detailed information in pop-out

Morpho Alarms Causes
window
Review on Smear:
Presence of platelet aggregate, debris
DIF – N1: Debris or Small Cells
or resistant RBC.
Platelet Aggregates
Review on Smear:
DIF Noise
DIF – N2: Debris or Small Cells
Presence of platelet aggregate,
Probable Incomplete Erythrolysis
erythroblast or small lymphocytes.
Platelet Aggregates
Erythroblasts
Review the DIF Presence of atypical lymphocytes or
RL
Review on Smear basophiles.
- 41 -
H50/H51 Hematology Analyzer User Manual Test Results

DIF: Lymphocytes

Review the DIF Presence of basophiles, small

HL Review on Smear Neutrophils (without granulations or
DIF: Lymphocytes few segmented), band cells.
Presence of small Neutrophils
Review the DIF
(without granulations or few
NL Review on Smear
segmented), band cells or hyper
DIF: Neutrophils
basophil Monocytes.
Presence of giant Neutrophils, hyper
Review the DIF
segmented Neutrophils, eosinophils
NH Review on Smear
with few granulations or damaged
DIF: Neutrophils
eosinophils.
Presence of Immature Cells (from the
IMM DIF: Immature Cells
mono or polynucleated cells line).

ALY DIF: Atypical Lymphocytes Presence of atypical Lymphocytes

12.4 Pathological Alarms

These pathological alarms are not displayed on the screen but the users can decide whether to
print the pathological alarms out or not by the printer settings.

12.4.1WBC Pathological Alarms

Parameter Pathological Alarms Triggers

Leukocytosis WBC>WBC h
WBC
Leukopenia WBC<WBC l
Lymphocytosis LYM > LYM h (%/#)
LYM%/#
Lymphopenia LYM < LYM l (%/#)
MON%/# Monocytosis MON > MON h (%/#)
Neutrophilia NEU> GRA h (%/#)
NEU%/#
Neutropenia NEU<GRA h (%/#)
EOS%/# Eosinophilia EOS > EOS h (%/#)
BAS%/# Basophilia BAS > BAS h (%/#)
IMM%/# Immature Cells IMM> IMM h (%/#)
ALY%/# Atypical Lymphocytes ALY> ALY h (%/#)

- 42 -
H50/H51 Hematology Analyzer User Manual Test Results

12.4.2 RBC Pathological Alarms

Parameter Pathological Alarms Triggers

Erythrocytosis RBC>RBC h
RBC Presence of platelet aggregate, erythroblast
Erythroblasts
or small lymphocytes at the left of L1.
HGB Anemia HGB < HGB l
Microcytosis/Microcytes MCV<MCV l
MCV
Macrocytosis/Macrocytes MCV>MCV h
Hypochromia MCHC<MCHC l
MCHC
Cold Agglutinin MCHC>MCHC h
RDW CV Anisocytosis RDW CV > RDW CV h
RDW SD Anisocytosis RDW SD > RDW SD h

12.4.3 PLT Pathological Alarms

Parameter Pathological Alarms Triggers

Thrombopenia PLT<PLT l
Thrombocytosis PLT>PLT h
Small platelets PLT>PLT h
Presence of abnormal quantity of debris or
PLT Platelet Debris
small cells at the left of CP1.
Presence of platelet aggregate, debris,
Platelet Aggregates resistant RBC, erythroblast or small
lymphocytes.
Presence of schizocytes between CP1 and
Schistocytes
CP2.
MPV Giant platelets MPV> MPV h

- 43 -
H50/H51 Hematology Analyzer User Manual Service

Chapter 13 Service
Press Service on the main screen to enter into the Screen 12-1.

Screen 12-1

13.1 System Initialization

Press System Init ( ) and the system will automatically perform mechanical
initialization.

13.2 Event Logs

Press Event Logs ( ) to

enter into the Event Logs Screen.

The event logs record the information: Date

/Time, Operator, Event and description. It
can store up to 1000 data entries. The
system displays 14 data entries on every
page.

Event Logs Screen

- 44 -
H50/H51 Hematology Analyzer User Manual Service

13.3 Error Logs

Press Error Logs ( ) to enter

into the Error Logs Screen.

The error logs record the following information:

Date /Time, Operator, Event and description. It
can store up to 1000 data entries. The system
displays 14 data entries on every page.

Error Logs Screen

13.4 Backup & Restore Backup Procedures:

1ͨ Select Data and Setup.
2ͨ Press Backup, the system will pop out a message to
prompt users to insert external storage device.
3ͨ Insert USB Disk into the analyzer, the system will
pop out a message to prompt users that the backup is
in progress.
4ͨ After completion of backup, the system will pop out
a message to hint users that the backup is completed.
Restore Procedures:
1ͨ Press “Restore”, the system will pop out a message
to prompt users to insert external storage device.
 2ͨ Insert USB Disk into the analyzer, the system will
pop out a message to prompt users that the restore is
Backup & Restore Screen in progress.
3ͨ After completion of restore, the system will pop out
13.5 Settings a message to hint users that the restore is completed.

Press Settings ( ) to enter into

the Settings screen.
You can perform the following settings with
this screen:
‹ Lab Parameters
‹ Date/Time
‹ Automatic Cycles
‹ Printer
‹ Communication
 ‹ Users Management
Settings Screen ‹ Software Update
- 45 -
H50/H51 Hematology Analyzer User Manual Service

13.5.1 Lab Parameters Setting

Press Lab Parameters to enter into the
Screen 12-2.

You can perform the following settings with

this screen:
‹ Lab Preferences
‹ Units
‹ CBC Thresholds and Flags
‹ DIF Flags
‹ Reference Ranges
 ‹ Calibration Factors

Screen 12-2

13.5.1.1 Lab Preferences

Press Lab Preferences to enter into Lab Preferences Screen. You can perform the following
settings on the screen.
In accordance with actual needs, select Absolute or
Percentage for DIF Format from the dropdown menu.

SID Start #: Enter a figure to be the SID starting No.

Auto-Incrementing SID: If enable this function, the
sample ID will increase automatically from the SID
starting No.

QC Alert: If enable this function, QC NOT DONE

(if QC is not done during the Day) or QC
FAILED (if the last QC test failed) will be
displayed as the system alerts.
Lab Preferences Screen
Enable RUO: If enable this function, the RUO
(Research Use Only) parameters will be displayed
after tests.
NOTE: RUO includes ALY and IMM.

NOTE:

When SID Start# is modified, press to

save the modification, then the prompt will
be displayed to hint users.

- 46 -
H50/H51 Hematology Analyzer User Manual Service

13.5.1.2 Units
Press Units to enter into Units Screen as the following two screens show. There are seven units
system. Users can select one unit system from the dropdown menu in accordance with actual
needs.

NOTE:
The difference between SI and SI MODE is that “g” is used in SI unit system while
“mmol” is used in SI MODE unit system.

13.5.1.3 CBC Thresholds and Flags

Press CBC Thresholds and Flags to enter into

the CBC Thresholds and Flags Screen.
Press Factory Setting to restore the default
values.
It’s recommended not to edit the default values
for any changes can affect the instrument’s
performance and morphological alarms
mechanism. Only technical persons are allowed
to edit values on this screen.

CBC Thresholds and Flags Screen Please refer to Section 12.3 in this manual for
more details.

- 47 -
H50/H51 Hematology Analyzer User Manual Service

13.5.1.4 DIF Flags

Press DIF Flags to enter into the DIF Flags
Screen.
Press Factory Settings to restore the default
values.
NOTE:
9 It’s not recommended to edit the default
values for any changes can affect the
instrument’s performance and trigger
morphological alarms. Please refer to
 Section 12.3 for more details.
9 Only technical persons are allowed to
DIF Flags Screen
edit values on this screen.
13.5.1.5 Reference Ranges
Press Reference Ranges to enter into the
Reference Ranges Screen.
There are 12 sets of reference ranges which
can be defined by users in accordance with
their own laboratories’ regulations, locations’
difference or other considerations. In
addition, there is default, neonate, child, adult
male and adult female reference range
available for user’s selection.
 Steps for set reference ranges:
Reference Ranges Screen 1) Select a number from the User Defined
Groups area.
2) Set neonate and child’s age range.
3) Press EDIT REF. RANGES to enter
Reference Ranges Edition screen.
4) Select the number from the drop-down
list that you have selected in the
Reference Ranges Screen.
5) Edit parameters’ reference ranges, then

press to save.

Reference Ranges Edition Screen

- 48 -
H50/H51 Hematology Analyzer User Manual Service

NOTE:

1) Press EDIT CBC to edit CBC

parameters’ values. Press EDIT
DIF to edit DIF parameters’
values.
2) The two buttons, EDIT CBC and
EDIT DIF, can be mutually
switched.



Reference Ranges Edition Screen

Press FACTORY SETTINGS, the left

prompt will pop out. If you want to restore

the factory settings, press .

13.5.1.6 Calibration Factors

Press Calibration Factors to enter into the

Calibration Factors Screen.
The calibration factors can be updated as:
9 Update the calibration factors
automatically as the instructions specified
in Chapter 8.
9 Update the calibration factors directly by
changing figures on this screen after
doing tests on reference analyzer.

Calibration Factors Screen

NOTE:
Only technical persons are allowed to change the calibration factors for any changes
can affect the analyzer’s performance.

- 49 -
H50/H51 Hematology Analyzer User Manual Service

13.5.2 Date/Time Setting

Press Date/Time to enter into the Date/Time

Screen.

On this screen, you can select date and time

format and set the current time and date as
the system’s time and date.

Date/Time Screen

13.5.3 Automatic Cycles Setting

Press Automatic Cycles to enter into Automatic Cycles Screen. You can perform the following
settings on the screen.

Automatic Power up Setting: If you

enable this function, the system will
automatically switch on at your
designated time.

Automatic Cycles Screen

Auto Clean: If the operator sets the auto clean frequency (analysis runs number), the system will
launch clean operation at the designated frequency. The auto clean frequency ranges from 10 to
5000 and the default frequency is 100. The operator can change the default value in accordance
with actual needs.
Auto Shutdown: If the operator enables this function, the system will shut down after the
designated idle duration. The idle duration ranges from 30 minutes to 720 minutes and the default
idle duration is 180 minutes. The operator can change the default value in accordance with actual
needs.
NOTE: mn means minute.

- 50 -
H50/H51 Hematology Analyzer User Manual Service

13.5.4 Printer Setting

‹ Printer Management

Screen 12-3 Screen 12-4 Screen 12-5

1) Connect printer to the analyzer as instructions in printer’s user manual.

2) Press Printer Management to enter into Screen12-3.The connected printer’s information
will be displayed.

3) Click “Not Installed” and Screen 12-4 will displayed. Press and Screen 12-5 will pop
out.

4) Select the targeted printer’s name and Press to finish the printer’s management.

5) Press and a new Setup window will pop out as Screen

12-6 shows. With this Setup window, you can:

1) Press to delete the installed printer.

2) Press to print a test page.

3) Press to set the printer as a default one.

4) Press to pause or resume printing.

5) Press to empty the printing list.

6) Press to close the Setup window.

Screen 12-6

- 51 -
H50/H51 Hematology Analyzer User Manual Service

‹ Printer Settings

Press Printer Settings to enter into

Screen12-7.

H1: Enter hospital’s name.

H2: Enter test report’s name.
Patient Report Options: Select what you
want to print out.
AutoPrint: Select what you want them to be
printed out automatically after tests.
Printer Selection: Select the targeted printer

and the paper size from the dropdown menu
Screen12-7 pursuant to actual needs.

13.5.5 Communication Setting

Press Communication to enter into Screen12-8. Press Communication Setup in Screen12-8 to
enter into Screen 12-9.

 
Screen12-8 Screen12-9
With the two screens, the operator can do the communication setting to transmit analysis results,
QC results and calibration test results to some data management systems such as hospital
LIS/HIS system. Please operate in accordance with the following procedures:
1) Do host settings in Screen 12-9:
Enter Address and Port of host which is intended to connect with the H50 analyzer.
2) Do analyzer settings in Screen 12-9:
Dis-select DHCP, manually enter address, mask and gateway. Alternatively, select DHCP and the
analyzer will automatically obtain address, mask and gateway and display them in the screen.

3) Press in Screen 12-9 to return to Screen 12-8.

4) Select communication mode (Serial, Ethernet, None) and the default communication mode is
None.
- 52 -
H50/H51 Hematology Analyzer User Manual Service

NOTE:
If None is selected, the communication between H50 analyzer and data
management system will fail. Therefore only Serial or Ethernet can be selected if
you want the communication between H50 analyzer and data management system
succeeds.
5) Select format (CSV Format, HL7 Format) and the default communication one is CSV Format.
6) Select which kind of test results (analysis result, QC result or Calibration report) that you
want to automatically transmit from H50 analyzer to the connected data management system.
NOTE:
Both analysis result and QC result can be transmitted from H50 analyzer to the
connected data management system via CSV format or HL7 format, while
Calibration report can only be transmitted from H50 analyzer to the connected data
management system via CSV format

7) Press in Screen 12-8 to save the settings made by the operator and the system will
automatically transmit the selected test results (analysis result, QC result or Calibration
report) to the connected data management system after test.

13.5.6 Users Management Setting

Press Users Management to enter into Users
Management Screen.

On the screen, you can add login ID, change

password and remove login ID.

1) Press Add to enter into Screen 12-10 to

add login ID.
2) Select a login ID that you plan to change
its password and then press Change
Password to enter into Screen 12-11 to
the change password.
Users Management Screen 3) Select a login ID that you plan to remove
and press Remove then the Screen 12-12
will pop out.

- 53 -
H50/H51 Hematology Analyzer User Manual Service

Add Login ID

Enter the first name ( İ10 characters), last

name ( İ 10 characters), login ID ( İ 8
characters), new password (İ 6 characters)
and confirmed password (İ 6 characters) in
the corresponding field. Select Operator or
Administrator in accordance with your needs.

Screen 12-10

Change Password

Enter the new password and confirmed

password in the corresponding field.

Screen 12-11

Remove Login ID

Select a login ID that you plan to

remove and press Remove then the

Screen 12-12 will pop out. Press to

 delete the selected login ID.
Screen 12-12

13.5.7 Software Update Management

Only technical persons can access to the software update setting.

- 54 -
H50/H51 Hematology Analyzer User Manual Service

13.6 Troubleshooting

13.6.1 Troubleshooting via Software

Press Troubleshooting to enter into
Troubleshooting Screen. You can do the
following troubleshooting with this screen.
1) Fluidics Control 9) Rinse
2) Bleach Cleaning 10) Clean
3) Drain Baths 11) Drain for Pack up
4) Backflush Apertures 12) Syringe Greasing
5) Backflush Opt. Bench 13) Drain Flow Cell
6) Needle Dismantling 14) Check Sensors/Valves
7) Check Rocker 15) Check Syringe
8) Park Motors 16) Check Needle

Troubleshooting Screen

Problems Operation (Solution) NOTE

Mechanical/fluidic
Fluidics Control
problems or perform an
emergency stop
Firstly recommended to use this operation to
Clean
solve the problem.
Secondly, if some parameters such as WBC,
No WBC, RBC or PLT RBC and PLT measured by counting baths
test results Backflush Apertures are always not displayed after tests, perform
this operation to push cleaner into WBC and
RBC apertures in order to remove a potential
clogging.
Secondly, if Some parameters such as LYM,
MON, NEU, EOS, BAS measured by the
optical bench system are always not
Backflush Opt. Bench
displayed after tests, perform this operation
to push cleaner into the flow cell in order to
remove a potential clogging
It’s the most effective way to solve the
No LYM, MON, NEU, problem but it will take 15 minutes.
EOS or BAS test results Therefore, if the first two operations can’t
solve the problem, it will be the last resort.
Bleach Cleaning In addition, If 50 tests per day, it is
recommended to perform the operation one
time a week.
Please refer to Section 13.6.1.1 for detailed
instructions of performing bleach cleaning
cycle.
This operation will drain the counting baths
Rinse
and refill the counting baths with diluents.
- 55 -
H50/H51 Hematology Analyzer User Manual Service

This operation is only for technical persons

Replace or maintain
Drain Baths not users.
counting baths
Replace optical bench This operation is only for technical persons
Drain Flow Cell
system. not users.
This operation allows moving the sampling
module to a position so that it’s very
Replace sampling needle convenient for users to access to the
and/or rinsing head O- Needle Dismantling sampling needle
ring Please refer to Section 13.6.1.3 for detailed
instructions of performing needle
dismantling.
Transport analyzer to a
Park Motors
new place.
Transport analyzer to a This operation will use bleach and distilled
new place or stop to use water to do a complete cleaning of the
the analyzer for a long analyzer and then dry the whole fluidic
time. system.
This operation allows moving the pistons
down in order to perform the greasing.
Grease syringe’s piston Syringe Greasing
Please refer to Section 13.6.1.2 for detailed
instructions of performing syringe greasing.
This operation controls the functionality of
Check Rocker the sampling module transversal axis and
checks the motor and sensors.
This option allows controlling the syringe
Check Syringe module functionality and checks the syringe
Motors’ problems
motor and sensor.
This option allows controlling the
functionality of the Y axis of the sampling
Check Needle
module, this function checks the motor and
sensors.
Check Valves and Please refer to Section 13.6.1.2 for detailed
Check Sensors/Valves
Sensors information.

13.6.1.1 Instructions for Performing Bleach Cleaning

1) Press Bleach Cleaning, the following screen pops out.

- 56 -
H50/H51 Hematology Analyzer User Manual Service

2) Press the following screen pops out.

3) When the following screen pops out, open the fluidic door with screw driver and add 4mL of
bleach (Sodium Hypo chloride solution) into RBC bath and WBC bath respectively.

NOTE͵

The system will beep when it requires the user to pour the bleach into the baths

4) Close fluidic door and Press on the pop-out. The system will automatically perform
bleach cleaning.
13.6.1.2 Instructions for Performing Syringe Greasing

Wear rubber glove on one Spread a thin film of With a tool key type T20,
hand and place a bit of grease on each piston. turn the two waste pistons in
silicon grease at the tip of order to spread the grease all
the index. around the pistons.

- 57 -
H50/H51 Hematology Analyzer User Manual Service

13.6.1.3 Instructions for Performing Needle Dismantling

Pull on the top of the Pull on the rinsing head

needle to remove it from to remove it from the
the needle carriage. sampling module.

13.6.1.4 Check Sensors/Valves

Press Check Sensors/Valves to enter into

Check Sensors/Valves Screen. With this
screen, you can:
1) Set HGB LED ON/OFF: Turn HGB
LED ON or OFF
2) Set AC ON/OFF: Turn Apertures current
ON or OFF
3) Set OPT LED ON/OFF:Turn Optical
LED ON or OFF
4) ALL EV ON/OFF: Set All EVs ON or
OFF
5) EV Chaser: Each EVs will be set on/off
Check Sensors/Valves Screen
consecutively
13.6.2 Parameters Troubleshooting
Parameters Problems Solutions
No HGB test results Check HGB LED wires.
WBC
HGB test result is OK 1) Check the electrode wires.
while no other 2) Firstly perform a Clean cycle. If the problem is still
parameters’ test results. unresolved, then perform a Bleach Cleaning cycle.

- 58 -
H50/H51 Hematology Analyzer User Manual Service

1) Firstly perform a Backflush cycle. If the problem is

still unresolved, then perform a Clean cycle. If the
problem is still unresolved, lastly perform a Bleach
Bad stability
Cleaning cycle
2) Check if there are bubbles in WBC bath during the
analysis cycle.

No HCT or PLT test 1) Check the electrode wires.

2) Firstly perform a Clean cycle. If the problem is still
results
unresolved, then perform a Bleach Cleaning cycle.
1) Firstly perform a Backflush cycle. If the problem is
RBC still unresolved, then perform a Clean cycle. If the
problem is still unresolved, lastly perform a Bleach
No HCT or PLT test Cleaning cycle
results ; Bad stability 2) Check if there are bubbles in RBC bath during the
analysis cycle.
3) Check the level of bubbles in WBC bath during the
first dilution.
No results Check if the HGB LED light is on.
1) Check the level bubble flow in the WBC bath
HGB Bad stability during the run cycle.
2) Change Lyse reagent
Rejection Perform a new Start Up cycle.

13.6.3 Mechanical Problems Troubleshooting

Problems Solutions

Diluent leaks around the 1) Check the rinsing needle block (presence of clots) and clean
it if necessary
needle during sample tests
2) Check the rinsing head.
1) Check the power supply connection wires.
Fail to turn on the analyzer
2) Check the Power Supply block
1) Check whether diluent container is placed at the same level
with the analyzer and whether the diluent tubing is not
All test results are bad.
pinched.
2) Check the diluent’s remaining volume.
No test results are displayed Check the screen wires which are connected to CPU board.
1) Check the paper.
No printing
2) Check the electrical connection.

- 59 -
H50/H51 Hematology Analyzer User Manual Service

13.7 Maintenance

13.7.1 Automatic Bleach Cleaning Maintenance

Press Maintenance to enter into Maintenance

Screen. On the Screen, the operator can
determine the frequency of performing bleach
cleaning cycle by setting the following items.
No matter which one is reached, the system will
pop out Screen 12-13 to prompt users to perform
bleach cleaning cycle when you press
Shutdown to turn off analyzer.
‹ Number of Cycles (ranging from 50-300

and the default value is 300)
‹ Bleach Frequency (Days) (ranging from 1-
Maintenance Screen 30 and the default value is 7)

On Screen 12-13, select Bleach + Shutdown

and then press , the system will

automatically perform bleach cleaning cycle
and finally shut down the analyzer.

Screen 12-13

If you select Shutdown on Screen 12-13

and then press to shut down the

analyzer directly. The system will pop out
Screen 12-14 when you turn on analyzer
next time to prompt users to do the bleach
cleaning cycle.

Screen 12-14

13.7.2 Regular Maintenance

The following maintenance table is recommended to user when:
z 50 samples are tested per day.
z 6 x 52 working days per year

- 60 -
H50/H51 Hematology Analyzer User Manual Service

z If the number of tested samples increases, the frequency of maintenance needs to be

increased proportionally.

Maintenance Period Maintained by customer Maintained by Field Service Engineer

Weekly Bleach Cleaning cycle --

Monthly None None

Quarterly
None None
(3900 cycles)
Biannually
None None
(7800 cycles)
Annually Needle O-ring
None
(15 600 cycles) Piston greasing
Three years
None Syringes block and pistons exchange
(46800 cycles)

13.7.3 Cleaning and Disinfecting the Analyzer

Follow proper safety procedures and take protective measures such as wearing approved
gloves when cleaning and disinfecting the system.

Cleaning and Disinfecting the Exterior Surfaces

Clean and disinfect the exterior surfaces to remove dust, splatters, etc. Policies regarding the
cleaning and disinfecting intervals are at the discretion of your individual institution.

1) Turn off the analyzer.

2) Disconnect the power cord and the power adaptor.

3) Disconnect the connecting cables if the system is connected to other pieces of equipment.

4) Dampen a lint-free cloth with detergents or disinfectants.

NOTE:

The cloth should be wet but not dripping.

The validated detergents for cleaning the system are:

9 Ethanol (75%)

9 Isopropanol (70%)

The validated disinfectants for cleaning the system are:

9 HB300 Bleach δproduced by Edanε

- 61 -
H50/H51 Hematology Analyzer User Manual Service

5) Clean the exterior surfaces with the wet cloth.

6) Clean the surfaces with the wet cloth to disinfect them after the surfaces are completely dry.

NOTE:

9 Clean the surfaces prior to disinfecting them.

9 Make sure the surfaces are thoroughly dry before disinfecting them.

7) When the surfaces are thoroughly dry, reconnect the power cord, power adaptor and other
connecting cables.

- 62 -
H50/H51 Hematology Analyzer User Manual Logout and Shutdown

Chapter 14 Logout and Shutdown

14.1 Logout

Press Log Out on the main screen, they

system will go back to Login Screen.

14.2 Shutdown

1) Press Shut Down on the main screen,

they system will pop out Screen 13-1.

2) Press on Screen 13-1 and the Screen

13-2 will pop out.
3) Select Shutdown to directly turn off the
analyzer or select Bleach + Shutdown to
perform bleach cleaning firstly and then
turn off the analyzer (when Bleach cycle
is recommended)

Screen 13-1 Screen 13-2

- 63 -
H50/H51 Hematology Analyzer User Manual Warranty and Service

Chapter 15 Warranty and Service

15.1 Warranty
EDAN warrants that EDAN’s products meet the labeled specifications of the products and will be
free from defects in materials and workmanship that occur within the warranty period.

a) The warranty is void in cases of:

b) Damage caused by mishandling during shipping.

c) Subsequent damage caused by improper use or maintenance.

d) Damage caused by alteration or repair by anyone not authorized by EDAN.

e) Damage caused by accidents.

f) Replacement or removal of serial number label and manufacture label.

If a product covered by this warranty is determined to be defective because of defective materials,

components, or workmanship, and the warranty claim is made within the warranty period, EDAN
will, at its discretion, repair or replace the defective part(s) free of charge. EDAN will not provide
a substitute product for use when the defective product is being repaired.

15.2 Contact Information

If you have any question about maintenance, technical specifications or malfunctions of devices,
contact your local distributor.

Alternatively, you can send an email to EDAN service department at: [email protected].

- 64 -
H50/H51 Hematology Analyzer User Manual Specifications

Appendix 1 Specifications
A1.1 Environment Requirements

Temperature 18 – 32 °C
Usage
H50/H51 Humidity ʇ80%
Hematology
Analyzer Transport and Temperature -10°C to 50°C
Storage Humidity ʇ80%

A1.2 Analyzer Specifications

Size 406mm x 275mm x 430mm (approx.) (depth × width × height)

Weight 13kg (approx.)

LCD Touch-screen 10.4 inch (800mm*600mm)
5 USB ports
Connection Ethernet-RJ45
Serial LIS-SUB D9

A1.3 Performance Specifications

15.6 μL (WB Mode and CAP Mode)

Sample Volume
20 μL (PD Mode); Dilution Rate:1:15

Throughput 1test/ 60s

A1.4 Power Adapter

Size 175mm x 72mm x 35mm (approx.) (depth × width × height)

Weight 0.6kg (approx.)

Input 100-240VAC, 50/60Hz, 2.0A
Power
Output 24VDC, 6.67A, 160W Max.

- 65 -
H50/H51 Hematology Analyzer User Manual Analytical Performance

Appendix 2 Analytical Performance

A2.1 Linear Range
Parameter Linear Range Limits r
WBC 0×109/L ~10×109/L ±0.3×109/L ≥0.990
10.1×109/L~100×109/L ±4% ≥0.990
RBC 0×1012/L ~1. 00×1012/L ±0.05×1012/L ≥0.990
1.01×1012/L ~8.00×1012/L ±3% ≥0.990
HGB 0 g/L ~70g/L ±2 g/L ≥0.990
71g/L~250 g/L ±2% ≥0.990
PLT 0×109/L ~100×109/L ±10×109/L ≥0.990
100×109/L ~2000×109/L ±5% ≥0.990

A2.2 Background

Parameter Background/Blank Count Requirements

WBC ʇ0.2×109/L
RBC ʇ 0.02 ×1012/L
HGB ʇ 1 g/L
PLT ʇ 10 ×109/L

A2.3 Precision
Parameter Range Precision
WBC 3.5×109 / L ~6.0u 109 / L ≤3.0%
6.1u 109 / L ~15.0×109 / L ≤2.5%
RBC 3.5×1012/ L -6.5×1012/ L ≤1.5%
HGB 110 g/L -180 g/L ≤1.5%
PLT 100×109 / L -500×109 / L ≤4.0%
MCV 70 fL -120 fL ≤1.0%
HCT 35%-55% ≤ 2.0%

A2.4 Carry-over

Parameter Carry-over
WBC ʇ0.5%
RBC ʇ0.5%
HGB ʇ0.6%
PLT ʇ1%

- 66 -
H50/H51 Hematology Analyzer User Manual Analytical Performance

A2.5 Accuracy
Parameter Detection Range Limit (%)
WBC 3.5×109 / L ~9.5× 109 / L ±6
RBC 3.8× 1012/ L ~5.8× 1012/ L ±4.0
HGB 110 g/L ~180 g/L ±3.0
PLT 125×109 / L ~350×109 / L ±13.0
MCV 82 fL ~100 fL ±6.0
HCT 35% ~55% ±6.0

A2.6 Measurement Range

Parameter Units* Measurement Range
WBC 109/L 0-150
RBC 1012/L 0-15
HGB g/L 0-25
HCT % 0-100
MCV fL 0 - 150
PLT 109/L 0 - 4000
RDW-CV % 0 – 100
RDW-SD fL 0 – 100
MPV fL 0 – 50
MCH pg 0 – 50
MCHC g/L 0 – 50
PCT % 0 – 100
PDW % 0 – 50
PLCR % 0 - 100
PLCC 109/L 0 - 4000
LYM, MONO, NEU, EOS,
109/L 0-150
BASO, ALY, IMM #
LYM, MONO, NEU, EOS,
% 0-100
BASO, ALY, IMM %

- 67 -
H50/H51 Hematology Analyzer User Manual EMC Information

Appendix 4 EMC Information

NOTE:
9 The system complies with the emission and immunity requirements of IEC61326.
9 The system has been designed and tested to CISPR 11 Class A. In a domestic
environment it may cause radio interference, in which case, you may need to take
measures to mitigate the interference.
9 The electromagnetic environment should be evaluated prior to operation of the
system.
9 Do not use the system in close proximity to sources of strong electromagnetic
radiation (e.g. unshielded intentional RF sources), as these may interfere with the
proper operation.
9 Use of this instrument in a dry environment, especially if synthetic materials are
present (synthetic clothing, carpets etc.) may cause damaging electrostatic
discharges that may cause erroneous results.”

Guidance and manufacture’s declaration - electromagnetic emissions-

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic emission

The system is intended for use in the electromagnetic environment specified below. The user of
the system should ensure that it is used in such an environment.

Emission test Compliance Electromagnetic environment – guidance

The system uses RF energy only for its internal

RF emissions function. Therefore, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference to nearby
electronic equipment.

RF emissions
Class A
CISPR 11

Harmonic
emissions Not Applicable The system is suitable for use in all establishments
IEC 61000-3-2 other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage
fluctuations/ flicker
Not Applicable
emissions
IEC 61000-3-3

- 68 -
H50/H51 Hematology Analyzer User Manual EMC Information

Guidance and manufacture’s declaration - electromagnetic immunity -

for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity

The system is intended for use in the electromagnetic environment specified below. The customer
or the user of the system should ensure that it is used in such an environment.
IEC 61326 Electromagnetic
Immunity test Compliance level
test level environment -guidance
Electrostatic ±4 kV contact ±4 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile.
IEC 61000-4-2 If floor is covered with
synthetic material, the
relative humidity should
be at least 30%.
Electrical fast ±1 kV for power ±1 kV for power Mains power quality
transient/burst IEC supply lines supply lines should be that of a typical
61000-4-4 commercial or hospital
environment.
Surge ±1 kV line to line ±1 kV line to line Mains power quality
IEC 61000-4-5 ±2 kV line to ground ±2 kV line to ground should be that of a typical
commercial or hospital
environment.
Power frequency 3 A/m 3 A/m Power frequency
(50 Hz/60 Hz) magnetic fields should be
magnetic field at levels characteristic of
IEC 61000-4-8 a typical location in a
typical commercial or
hospital environment.
Voltage dips, short 0% UT (100% dip in 0% UT (100% dip in Mains power quality
interruptions and UT) for 1 cycle UT) for 1 cycle should be that of a typical
voltage variations commercial or hospital
on power supply 40% UT (60% dip in 40% UT (60% dip in environment. If the user
input lines UT) for 5/6 cycles UT) for 5/6 cycles of the system requires
IEC 61000-4-11 continuous operation
70% UT (30% dip in 70% UT (30% dip in during power mains
UT) for 25/30 cycles UT) for 25/30 cycles interruptions, it is
recommended that the
<5% UT (>95% dip in <5% UT (>95% dip in system be powered from
UT) for 250/300 cycles UT) for 250/300 cycles an uninterruptible power
supply or a battery.

69
H50/H51 Hematology Analyzer User Manual EMC Information

Field strengths from

fixed RF transmitters, as
determined by an
electromagnetic site
Conducted RF IEC 3 Vrms 3 Vrms survey,a should be less
61000-4-6) 150 kHz to 80 MHz than the compliance level
in each frequency range.b
Interference may occur in
3 V/m 3V/m (80 MHz to the vicinity of equipment
Radiated RF 80 MHz to 1 GHz 1GHz ) marked with the
IEC 61000-4-3 3V/m (1.4GHz to 3V/m (1.4GHz to following symbol:
2GHz) 2GHz)
1V/m (2.0GHz to 1V/m (2.0GHz to
2.7GHz) 2.7GHz)

NOTE 1 UT is the a.c. mains voltage prior to application of the test level.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
NOTE 3: Over the frequency range 150kHz to 80 MHz, field strengths should be less than 3 V/m.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
can not be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the system is used exceeds the applicable RF compliance level
above, the system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the system.

70
H50/H51 Hematology Analyzer User Manual Safety Specifications

Appendix 3 Safety Specifications

IEC 61010-1: 2010, IEC 61010-2-101: 2015
Comply with
IEC 61326-1: 2012, IEC 61326-2-6: 2012
The system meets the requirements of IEC 61010-1: 2010 at 5 –
Safety temperature
40 °C, but it cannot work at the temperature greater than 32 °C.
Maximum relative humidity 80% for temperatures up to 32 °C
Safety humidity range
decreasing linearly to 50% relative humidity at 40 °C.
Pollution degree 2
Degree of protection against
Ordinary equipment (Sealed equipment without water proof)
harmful ingress of water
Degree of safety in presence
Equipment not suitable for use in presence of flammable gases
of flammable gases
EMC CISPR 11 Group 1, Class A

Mode of operation Continuous (Indoor use only)

Altitude 3000m

- 71 -
H50/H51 Hematology Analyzer User Manual Glossary

Appendix 5 Glossary
Abbreviation Full Name
WBC Leucocytes Total Count
LYM%/# Lymphocyte percent and absolute value
MON%/# Monocyte percent and absolute value
NEU%/# Neutrophil percent and absolute value
EOS%/# Eosinophil percent and absolute value
BAS%/# Basophils percent and absolute value
ALY%/#* Abnormal Lymphocyte percent and absolute value
IMM%/#* Immature Monocyte percent and absolute value
RBC Red Blood Cell Total count
HGB Hemoglobin
HCT Hematocrit
MCV Mean Cell Volume
MCH Mean Cell Hemoglobin
MCHC Mean Cell Hemoglobin Concentration
RDW-CV Red Blood Cells Distribution Width-CV
RDW-SD Red Blood Cell Distribution Width-SD
PLT Platelets Total count
MPV Mean Platelet Volume
PCT Plateletcrit
PDW Platelets Distribution Width
PLCR Large Platelets Cell Ratio
PLCC Large Platelets Cell Count
RUO Research Use Only
SID Sample Identification
PID Patient Identification
PD Pre-dilution
WB Whole Blood
CAP Capillary
DIFF Differentiation

- 72 -
H50/H51 Hematology Analyzer User Manual User Access

Appendix 6 User Access

Operator, administrator and technician have different rights to access into different menus or
submenus. The following table makes a detailed list about their different rights.
Menu Sub-menu Operator Administrator Technician
Startup √ √ √
Shutdown √ √ √
QC √ √ √
Calibration NO √ √
Repeatability √ √ √
Run Sample √ √ √
Results √ √ √
Logout √ √ √
Shutdown √ √ √
Prime All √ √ √
Diluent Prime √ √ √
Lyse Prime √ √ √
Reagents Cleaner Prime √ √ √
Waste Reset √ √ √
Cycle Counters Reset NO NO √
Reagents Log √ √ √
System Init √ √ √
Event Logs √ √ √
Error Logs √ √ √
Backup& Restore √ √ √
LAB X √ √
Preferences
Units X √ √
CBC
Thresholds and X √ √
Flags
Lab
DIFF
Parameters
Thresholds and X √ √
Flags
Reference
X √ √
Ranges
Calibration
NO √ √
Settings Factors
Service
Date and Time √ √ √
Automatic Cycles NO √ √
Printer
√ √ √
Settings
Printer
Printer
X √ √
Management
Communication NO √ √
Add NO √ √
Users Change
NO √ √
Management Password
Remove NO √ √
Software Update NO √ √
Trouble
√ √ √
shooting
Adjust DIF NO X √
Technician Adjust Others NO √
System Config NO X √
- 73 -
H50/H51 Hematology Analyzer User Manual User Access

NOTE:

1) ĸ means you have the right to enter into the screen to read its information and
perform operations.
2) X means you can only enter into the screen to read its information.
3) NO means you have no rights to enter into the screen.

- 74 -
- 75 -