Humacount 5D: - User Manual

HumaCount 5D
| User Manual
Cat No. 16450/1

REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2017-06 First Edition
02/2017-09 Change of Reagent names
03/2017-09 Addition of MSDS information
04/2018-04 Content list
05/2018-05 MPV Spec, Interfering substances, blood samples
06/2018-12 Display ranges, Corrections and tables
07/2019-01 Correction of typing errors
SYSTEM VERSION
COPYRIGHT
Copyright 2019, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden,
Germany. All rights reserved.
No part of this documentation may be reproduced in any form, nor processed, copied or
distributed by means of electronic systems, without prior permission of HUMAN in
writing. Since all precautionary measures were taken into account in producing these operating
instructions, the manufacturer accepts no responsibility for any errors or omissions. This
includes any liability for damage that could arise from possible incorrect operation based on this
information. Subject to changes without notice as result of technical development.
SERVICE UND SUPPORT

CONTENTS
TABLE OF CONTENTS
1 SAFETY INSTRUCTIONS 7
1.1 INTRODUCTION 7
1.2 USER WARRANTY 7
1.3 INTENDED USE OF THE INSTRUMENT 7
1.4 GENERAL SAFETY WARNINGS 8
1.5 DISPOSAL MANAGEMENT CONCEPT 8
1.6 BIOHAZARD WARNING 9
1.7 INSTRUMENT DISINFECTION 9
1.8 WHO SHOULD READ THIS MANUAL OF HUMACOUNT 5D 9
1.9 SPECIAL SYMBOLS USED IN THIS MANUAL AND ON THE ANALYZER 10
2 SYSTEM DESCRIPTION 13
2.1 INSTALLATION 13
2.2 INSTALLATION REQUIREMENTS 13
2.3 UNPACKING 14
2.4 INTRODUCTION 15
2.5 WHO SHOULD READ THIS MANUAL 15
2.6 STRUCTURE OF THE ANALYZER 15
2.6.1 Main unit 16
2.6.2 Touch screen 17
2.6.3 Aspirate key 17
2.6.4 Power/Status indicator 18
2.6.5 Power switch 18
2.6.6 USB interface 19
2.6.7 Network interface 19
2.6.8 External Equipment (Optional) 19
3 ROUTINE UTILIZATION AND MEASUREMENT 21

3.1 WORKING PRINCIPLE 21
3.1.1 Introduction 21
3.1.2 Aspiration 21
3.1.3 Dilution 21
3.1.4 Dilution Procedure in Predilute CBC+DIFF Mode 22
3.1.5 Flushing 23
3.1.6 WBC Measurement 23
3.1.7 HGB Measurement 27
3.1.8 HGB 27
3.1.9 RBC/PLT Measurement 27
3.1.10 Measurement Parameters 30
3.1.11 User Interface of HumaCount 5D 31
3.1.12 Reagents, Controls and Calibrators 39
3.1.13 Sample Collection and Handling 44
3.1.14 Sample Analysis 48
4 SAMPLE ANALYSIS 49
4.1 INTRODUCTION 49
4.2 INTERFACE INTRODUCTION 49
4.3 FUNCTIONS OF THE BUTTONS. 50
4.4 ENTERING SAMPLE INFORMATION 51
4.5 RUNNING SAMPLES 55
4.6 DEALING WITH THE ANALYSIS RESULTS 57
4.6.1 Automatic saving of analysis results 57
4.6.2 Parameter Flags 57
4.6.3 Flags of Abnormal Blood Cell Differential or Morphology 57
4.7 FUNCTIONS OF THE BUTTONS 60
4.7.1 Previous/Next 60
4.7.2 Mode & ID 60
4.7.3 Validate/Cancel Validation 60
4.7.4 Print 60
4.7.5 Patient Information 60
4.7.6 Customized Parameters 64
4.7.7 Microscopic Exam. Parameters 65
4.7.8 Communication 66
4.7.9 Edit Result 66
5 RESULT REVIEW 69
5.1 INTRODUCTION 69
5.2 INTERFACE INTRODUCTION 69
5.3 SAMPLE LIST 70
5.4 FUNCTIONS OF THE BUTTONS 70
5.4.1 Print 70
5.4.2 Delete 70
5.4.3 Export 71
5.4.4 Edit Result 74
5.4.5 Patient Info. 74
5.4.6 Query 79
5.4.7 Results 80
5.4.8 Microscopic Exam. Parameters 81
CONTENTS
5.4.9 Customized Parameters 83

5.4.10 Run Chart 84
6 DAILY OPERATIONS 87
6.1 PRE-OPERATION PREPARATION 87
6.2 STARTUP 88
6.3 DAILY QUALITY CONTROL 89
6.4 SAMPLE COLLECTION AND HANDLING 90
6.4.1 Sample Analysis 90
6.4.2 Interfering substances 90
7 ADVANCED OPERATION 91
7.1 QUALITY CONTROL 91
7.1.1 L-J QC overview 91
7.1.2 QC Settings 91
7.1.3 Quality Control Analysis 96
7.1.4 QC Result Review 102
7.2 X-B QUALITY CONTROL 111
7.2.1 QC Principle 111
7.2.2 QC Settings 112
7.2.3 Quality Control Analysis 115
7.2.4 QC Result Review 115
7.3 SETUP 122
7.3.1 Introduction 122
7.3.2 Interface Introduction 123
7.3.3 System Settings 124
7.3.4 Parameter Settings 128
7.3.5 User management 145
7.3.6 Print Settings 149
7.3.7 Auxiliary Settings 155
7.3.8 Connecting the Analyzer System 157
7.4 RANGES OF PARAMETERS. 165
7.4.1 Reference/Normal ranges 165
7.4.2 Analytical measurement ranges 166
8 CALIBRATION 167
8.1 INTRODUCTION 167
8.2 WHEN TO CALIBRATE 167
8.3 HOW TO CALIBRATE 168
8.3.1 Manual Calibration 168
8.3.2 Auto Calibration Using Calibrators 170
8.3.3 Auto Calibration Using Fresh Blood Samples 173
8.4 VERIFYING CALIBRATION COEFFICIENTS 175
9 REAGENT MANAGEMENT 177

9.1 ACCESSING THE INTERFACE 177
9.2 SETTING REAGENT INFORMATION 178
9.2.1 System Reagent 179
9.3 REPLACING REAGENTS 180
10 SERVICE 181
10.1.1 Cleaning 184
10.1.2 Maintenance 185
10.2 COMPREHENSIVE DEVICE MAINTENANCE 189
10.2.1 Fluidics Initialization 190
10.2.2 Auto Clean 195
10.2.3 Auto Prompt for Cleanser Soak 196
10.2.4 Auto Sleep 196
10.3 SELF-TEST 197
10.3.1 Syringe and Sampling Mechanism 197
10.3.2 Pressure and Vacuum 198
10.3.3 Valve & Pump 199
10.3.4 Others 199
10.4 SYSTEM STATUS 200
10.4.1 Temperature 201
10.4.2 Voltage and Current 201
10.4.3 Disk Information 202
10.5 LOG 202
10.5.1 All Logs 203
10.5.2 Parameter Revision Logs 203
10.5.3 Fault Logs 204
10.5.4 Other Logs 205
CONTENTS
10.6 DATA CLEANUP 205

10.7 VERSION INFORMATION 207
10.8 TOUCH SCREEN CALIBRATION 209
10.9 EXPORTING HOST INFORMATION FILE 209
11 TROUBLESHOOTING 211
11.2 DEALING WITH ERROR MESSAGES 211
11.3 ERROR MESSAGE REFERENCE 212
12 APPENDIX 223
Safety Instructions 7
1 SAFETY INSTRUCTIONS
1.1 Introduction
This manual is considered part of the instrument and must be available to the
operator and the maintenance personnel. For accurate installation, use and
maintenance, please read the following instructions carefully.
In order to avoid damage to the instrument or personal injury, carefully read
the ”GENERAL SAFETY WARNINGS”, describing the appropriate operating pro-
cedures. Please contact your HUMAN authorised local Technical Service in the
event of instrument failure or other difficulties with the instrument.
1.2 User Warranty

HUMAN warrants that instruments sold by one of its authorised representa-
tives shall be free of any defect in material or workmanship, provided that this
warranty shall apply only to defects which become apparent within one year
from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item within this
warranty period at no charge, except for transportation expenses to the point
of repair.
This warranty excludes the HUMAN representative from liability to replace any
item considered as expendable in the course of normal usage, e.g.: lamps,valves,
syringes, glassware, fuses, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty
if the product is not used in accordance with the manufacturer‘s instructions,
altered in any way not specified by HUMAN, not regularly maintained, used with
equipment not approved by HUMAN or used for purposes for which it was not
designed.
1.3 Intended Use of the Instrument

The instrument must be used for its intended purpose (see paragraph 2). It must
be operated in perfect technical conditions, by qualified personnel, in such [IVD]
working conditions and maintained as described in this manual, in the GENERAL
SAFETY WARNINGS. This manual contains instructions for qualified professional
operators.
8
1.4 General Safety Warnings

Use only chemical reagents and accessories specified and supplied by HUMAN
and/or mentioned in this manual. Place the product so that it has proper ven-
tilation.
The instrument should be installed on a flat, stationary working surface, that is
free of vibrations.
Do not operate in area with excessive dust.
Operate at temperature and at a humidity level in accordance with the specifi-
cations listed in this manual, chapter 2.2.
Do not operate this instrument with covers and panels removed.
Use only the power cord specified for this product, with the grounding
conductor of the power cord connected to earth ground.
Use only the fuse type and rating specified by the manufacturer for this instru-
ment.
The use of fuses with improper ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instru-
ment.
Do not power the instrument in environments that are potentially explosive or
at risk of fire.
Prior to cleaning and/or performing maintenance on the instrument, switch off
the instrument and remove the power cord.
Only cleaning materials described in this manual may be used, as other mate-
rials may damage parts. It is recommended to always wear protective clothing
and eye protection while using this instrument.
All warning symbols that appear in this manual must be carefully observed.
1.5 Disposal Management Concept

The applicable local regulations governing disposal must be observed. It is the
user‘s responsibility to arrange for proper disposal of the individual components.
All parts which may contain potentially infectious materials must be disinfect-
ed by suitable, validated procedures (autoclaving, chemical treatment) prior to
disposal. Applicable local regulations for disposal must be carefully observed.
The instruments and electronic accessories (without batteries, power packs etc.)
must be disposed of according to the applicable local regulations for the dispos-
al of electronic components.
Batteries, power packs and similar power sources must be removed from elec-
tric/electronic parts and disposed of in accordance with applicable local regula-
tions.
HumaCount 5D | User manual

1.6 Biohazard Warning

Analytical instruments for in vitro diagnostic application involve the handling of
human samples and controls which should be considered at least potentially in-
fectious. Therefore every part and accessory of the respective instrument which
may have come into contact with such samples must equally be considered as
potentially infectious.
The "BIOHAZARD" warning label must be affixed to the instrument prior to first
use with biological material!
Figure 1
Biological Hazard Symbol
1.7 Instrument Disinfection

Before performing any servicing on the instrument it is very important to thor-
oughly disinfect all possibly contaminated parts. Before the instrument is re-
moved from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination must be performed by authorised well-trained personnel, and
in observance of all necessary safety precautions.
1.8 Who Should Read This Manual of HumaCount 5D

This manual contains information written for clinical laboratory professionals
to:
-- Learn about the hardware and software of the analyzer.
-- Customize system settings.
-- Perform daily operations.
-- Perform system maintenance and troubleshooting.
10
1.9 Special Symbols used in this Manual and on the Analyzer

When you see... Then...
Follow the instruction in the manual related to the

the symbol to avoid potential biocontamination.

symbol to avoid personnel injury.

symbol to avoid analyzer damage and failure, or unre-
liable analysis results.
!
Note symbol. The symbol highlight the important infor-
mation in operating procedures that calls for special
attention.
Puncture Warning:
The sampling probe is sharp and may contain biohaz-
ardous materials. Special care should be taken when
working with it.
Laser Warning:
This sign serves as a reminder of laser radiation.
When you see... It means...
Caution
Biohazard
Exercise caution to prevent puncture
Laser radiation warning:

It is Class 3R laser product with 5.0 mW maximum
power output at 635 nm. Do not stare into the laser
beam or view directly with optical instruments.
Instruction for Moving
Network interface

When you
It means...
see...
Protective grounding
Alternating current (AC)
For in vitro diagnosis only
Lot No.
Expiry date
Serial No.
European CE declaration of conformity
Date of manufacture
Manufacturer
Storage temperature
Humidity level for storage
Atmospheric pressure level for storage
Consult the operator’s manual
Avoid sunlight
Keep dry
No rolling
No stacking
Let this side face upward

12
Fragile, handle with care
Recyclable materials
The analyzer, after being scrapped, should not be disposed

with other household garbage, instead, it should be collected
and recycled following the disposal instructions for scrapped
electronic and electrical equipment.

System Description 13
2 SYSTEM DESCRIPTION
2.1 Installation
The analyzer should only be installed by Human or its authorized agents. You
need to provide the appropriate environment and space. When the analyzer
needs to be relocated, please contact Human or your local agents. When you
receive the analyzer, please notify Human or your local agent immediately.
2.2 Installation Requirements
WARNING
-- Connect only to a properly grounded outlet.
-- Before turning on the analyzer, make sure the input voltage
meets the requirements.
CAUTION
-- Using a patch board may introduce electrical interference and
generate incorrect analysis results. Please place the analyzer
near the electrical outlet to avoid using the patch board.
-- Please use the original electrical wires shipped with the ana-
lyzer. Using other electrical wires may damage the analyzer or
generate incorrect analysis results.
Installation requirements for the analyzer are as follows.
Installation Requirements Table 1

Environment
Site -- Level ground and stable workbench with load capacity
≥50 kg.
-- Free of dust, mechanical vibration, heat and wind
sources, contamination, heavy-noise source or electri-
cal interference.
-- Avoid direct sunlight and keep good ventilation.
-- It’s recommended to evaluate the electromagnetic en-
vironment of the laboratory before operating the ana-
lyzer.
-- Keep the analyzer away from sources of strong electro-
magnetic interference, otherwise, its proper function-
ing may be affected.
14
Space (In -- At least 50 cm from each side, which is the preferred

addition to the access to perform service procedures.
space required -- At least 20 cm from the back for cabling and ventilation.
for the analyzer -- Enough room on and below the countertop to accom-
itself, set aside:) modate for the diluent and waste containers.
-- Place the analyzer near the electrical outlet and avoid
being blocked by any objects, so that you can discon-
nect the power plug easily as required.
Temperature 15°C~30°C
Relative 20%~85%
humidity
Operating atmos-
pheric pressure 70kPa~106kPa
Ventilation Keep air exchange to ensure good air circulation. The
wind should not blow directly at the analyzer.
Power AC100V~240V, Input Power ≤200VA, 50/60HZ.
Requirements
Electromagnetic Keep the analyzer away from electric-brush motors,
Wave flashing fluorescent and electric-contact equipment
which is switched on/off frequently.
Waste Disposal Dispose of the waste as per the requirements of the local
environment protection authorities.
2.3 Unpacking
Please unpack the analyzer by taking the following steps:
1. Open the outer packing box; take out the accessory pack; take out the ana-
lyzer together with the protective and cushioning materials.
2. Remove the foam and the protective PE bag.
3. Open the right door (open the linear-shaped cam lock on the right door with
a slotted screwdriver).
4. Remove the binder clips, which are used for fixating two conveyor belts. To
avoid the possible collision resulting from the slippage caused by shaking
and slanting during transportation, the central position of those two belts is
fixated with binder clips before they are shipped from the factory. The binder
clips must be removed during unpacking.
5. Remove the binder clips, which are used for fixating sampling assembly. To
avoid damage during the transportation, the sampling assembly of the ana-
lyzer is fixated with clamps. Do remove the clamps before using the analyzer.

2.4 Introduction
The HumaCount 5D is a quantitative, automated hematology analyzer and
5-part differential counter used in clinical laboratories. This section describes
in details the intended use, measurement parameters, structure, user interface
and compatible reagents of the analyzer.
2.5 Who Should Read This Manual

It is intended for blood cell counting, 5-part classification of white blood cell and
hemoglobin concentration measurement in clinical examinations.
The analyzer is intended for screening in the clinical examination. When making
clinical judgment based on the analysis results, the doctors should also take into
consideration the clinical examination results or other test results.
2.6 Structure of the Analyzer
WARNING
-- Please check the firmness of all the doors, covers and boards
before running the analyzer.
-- The analyzer is heavy, so moving by one person alone may
cause injury. It is advisable for two people to move it together
when the transportation is necessary, and make sure you fol-
low the instructions and use the proper tools.
-- To avoid electrical shocks, disconnect the power supply before
opening the cover.
-- To prevent fire, use the fuses with specified model number
and working current. The sampling probe is sharp and may
contain biohazardous materials. Special care should be taken
when working with it. This sign warns of laser radiation. Do
not look directly at the laser beams or see through the optical
instrument.
-- The sampling probe is sharp and may contain biohazardous
materials. Special care should be taken when working with it.
-- This sign warns of laser radiation. Do not look directly at the

laser beams or see through the optical instrument.
16
2.6.1 MAIN UNIT

The Hematology Analyzer consists of the main unit (analyzer) and accessories.
The main unit is for analysis and data processing.
Figure 2
Front of the analyzer
1 Touch screen 1
2 Power/Status indicator
3 Sample probe
4 Aspirate key

Figure 3
Back of the analyzer
3
1 Power switch
2 AC input
3 Cooling fan
4 Waste outlet
5 Diluent inlet
6 Waste level detection con-
nector
4 2
7 Diluent presence detection
5 1
connector
8 Ground studs
6 7 8
Figure 4
Side views of the analyzer
2
1 Network interface
1
2 USB interface
3 3 Right side door buckle
4 Left side small door buckle
4
2.6.2 TOUCH SCREEN

The touch screen is located on the front side of the analyzer for performing in-
terface operations and displaying the information.
2.6.3 ASPIRATE KEY

The aspirate key is located in the middle of the front side (behind the sample
probe). With this switch, one starts the sample analysis, adds diluents, or can-
cels sleep.
18
2.6.4 POWER/STATUS INDICATOR

The status indicator is located in the middle section of the analyzer (front side). It
shows the status of the analyzer including the following status, ready, running,
error, sleep and on/off, etc.
The indicators change with the status of the main unit. Details are shown in
Table 2.
Table 2
Instrument Status Indicator Status Remarks
Shutdown Off The main unit has been shut
Main Unit Status Indicators
down.
Stopped running with Red light on Stopped running with the
error conditions occurrence of errors
Running with error Red light flickering Running with the occur-
conditions rence of errors
Time sequence Yellow light on Initialization or sleep status
deactivated irrelevant to running
Running Green light flickering Execution of the sequence
actions is in process.
Ready Green light on Execution of the sequence
actions is allowed.
While the analyzer is running, if the status indicator turns dim or off, please
contact Human or Human’s agent for maintenance.
2.6.5 POWER SWITCH
CAUTION
-- To avoid damage, do not power on/off the analyzer repetitively
within a short time.
-- A power switch is located in the bottom back of the analyzer.
It turns on or shuts down the analyzer. Please use shut down
button of the software to turn off the analyzer.

2.6.6 USB INTERFACE

The USB interface is located on the right side of the main unit. There are 4 in-
terfaces in total for external equipment (printer, barcode scanner, mouse or
keyboard, usb flash disk) connection or data transmission.
2.6.7 NETWORK INTERFACE

The network interface is located on the right side of the main unit. There is 1
network interface in total for connecting with the Ethernet.
2.6.8 EXTERNAL EQUIPMENT (OPTIONAL)

The analyzer can be connected with the following external equipment:
-- Keyboard
The keyboard is connected with the USB interface on the right side of the
analyzer for controlling the analyzer.
-- Mouse
The mouse is connected with the USB interface on the right side of the ana-
lyzer for operations on the analyzer.
-- Printer
The printer is connected with the USB interface on the right side of the ana-
lyzer for printing reports and other information displayed on the screen.
-- Barcode Scanner
The barcode scanner is connected with the USB interface on the right side of
the analyzer for entering barcode information in an easy and fast way.
-- USB flash disk
The USB flash disk is connected with the USB interface on the right side of
the analyzer for exporting sample data.
20
2.7 Accessories
2.7.1 SCOPE OF SUPPLY
HumaCount 5D Hematology analyzer 1 16450
User Manual 1 16450/1

Quick Guide HumaCount 5D 1 16450/5-1
Quick Guide Capillary Blood Mode 1 16450/5-2
Reagent Operation Guide 1 16450/5-3
Peripheral grounding cable 1

Operator's Manual (HUMAN) 1
Quick Operation Guide Card 1
Diluent Adapter tube 1
Waste Float Adapter tube 1
Waste Container 1
2.7.2 OPTIONAL ACCESSORIES
2D Barcode Scanner 16430/11
Laser Printer 18993L

Routine Utilization and Measurement 21
3 ROUTINE UTILIZATION AND MEASUREMENT
3.1 Working Principle
3.1.1 INTRODUCTION
The measurement methods used in this analyzer are: the electrical Impedance
method for determining the RBC and PLT related parameters; the colorimetric
method for determining the HGB; laser-based flow cytometry for determining
the WBC related parameters. During each analysis cycle, the sample is aspirated,
diluted and mixed before the determination for each parameter is performed.
3.1.2 ASPIRATION
The analyzer supports Whole Blood mode (including Venous Whole Blood and
Capillary Whole Blood) and Predilute mode. In Whole Blood mode, the analyzer
will aspirate quantitative whole blood sample. In Predilute mode, the analyzer
will aspirate the prediluted sample (with the dilution ratio of 1:25) which is a
mixture of 20 μl of whole blood/capillary blood sample and 480 μl of diluent
the diluted sample thus prepared is then delivered to the analyzer for sampling
and aspiration.
3.1.3 DILUTION
After being aspirated into the analyzer, the sample is divided into two parts. Af-
ter the reaction with reagents in parallel dilution procedures, each part forms
the sample for red blood cell/platelet, white blood cell count/hemoglobin
! Note: CBC mode, namely
complete blood cell count, is
intended for counting only, not
measurement and white blood cell differential measurement. To meet different for white blood cell classification.
needs, the analyzer offers two working modes (Whole Blood and Predilute), and CBC+DIFF mode is intended for
two measurement modes (CBC and CBC+DIFF). Taking CBC+DIFF mode as an both counting and white blood
example, this section introduces the dilution procedures of the test sample in cell classification.
Whole Blood mode and Predilute mode separately. (The dilution procedure in
CBC mode is not introduced here since it’s the same as that in CBC+DIFF mode.)
22
3.1.3.1 Dilution Procedure in Whole-blood CBC+DIFF Mode

Dilution Procedures in Whole-Blood CBC+DIFF Mode are shown in Figure 5.
Whole blood sample

Figure 5 for the whole-blood
CBC+DIFF mode
Dilution Procedure in Discard the
bottom section of
▼
Whole-blood CBC+DIFF Mode
the samples
▼ ▼
Sampling Sampling
HC5D-Diluent
▼
HC5D-Diluent
▼
HC5D-Diff Lyse
▼
▼ ▼
Prepare WBC diff Dilute the sample
1 samples with certain
dilution ratios ▼
Take the sample that
has been diluted once
HC5D CBC Lyse from the WBC bath
▼
HC5D-Diluent
▼
▼ ▼
Prepare WBC samples Prepare RBC samples
3 and HGB samples with and PLT samples with 2
certain dilution ratios certain dilution ratios
The figure shows the steps of:

1. Dilution procedure for white blood cell diff; namely DIFF.
2. Dilution procedure for red blood cell and platelet.
3. The dilution procedure for white blood cell count/hemoglobin; namely CBC.
3.1.4 DILUTION PROCEDURE IN PREDILUTE CBC+DIFF MODE

In CBC+DIFF mode, the dilution procedure for the prediluted sample is shown in
Figure 6. The analyzer dispenses 480 ml HC5D-Diluent via the sample probe to
an Eppendorf cuvette. Please put the 20 µl of blood into the dispensed Eppen-
dorf cuvette and mix the sample carefully until you get a completely homoge-
nous sample.

20 ul of blood sample
180 ul of diluent Figure 6

▼
▼ Dilution Procedure in Predilute

Diluted sample with the
dilution ratio of 1:10 CBC+DIFF Mode
▼ ▼
Sampling Sampling
HC5 DIFF HC5D-

▼
▼
Lyse Diluent
▼ ▼
Prepare WBC diff Dilute the sample
1 samples with certain
dilution ratios ▼
Take the sample that
has been diluted once
HC5D CBC from the WBC bath
▼
Lyse
HC5D-
▼
Diluent
▼ ▼
Prepare WBC samples Prepare RBC samples
3 and HGB samples with and PLT samples with 2
certain dilution ratios certain dilution ratios
The figure shows the steps of:

1. The dilution procedure for white blood cell diff; namely DIFF.
2. The dilution procedure for red blood cell and platelet.
3. The dilution procedure for white blood cell count/hemoglobin; namely CBC.
3.1.5 FLUSHING
After each analysis cycle, each component of the analyzer is flushed.
3.1.6 WBC MEASUREMENT

The analyzer obtains the white blood cell 5-part classification results and white
blood cell count/basophils count using a semiconductor-laser-based flow cy-
tometry and eventually calculates the parameters relevant to white blood cells.
24
3.1.6.1 Working Principle of Laser-based Flow Cytometry

The principle of laser-based flow cytometry is illustrated by Figure 7.
Figure 7
WBC Measurement
After a predetermined volume of blood is aspirated and diluted by a certain

amount of reagent, it is injected into the flow chamber. Surrounded with sheath
fluid (diluent), the blood cells pass through the centre of the flow chamber in a
single column at a faster speed. When the blood cells suspended in the diluent
pass through the flow chamber, they are exposed to a laser beam.
The intensity of scattered light reflects the blood cell size and intracellular densi-
ty. The low-angle scattered light reflects cell size, while the high-angle scattered
light reflects intracellular density (nucleus size and density). The optical detec-
tor receives this scattered light and converts it into electrical pulses. Pulse data
thus collected can be used to draw a 3-dimensional distribution (scattergram)
as shown in Figure 8.

Figure 8
DIFF channel scattergram
BAS
Conduct dual channel detection to the white blood cells (WBCs). Use three-an-
gle laser scattering and flow cytometry for the count and classification of vari-
ous kinds of WBCs in dual channels. The abbreviations for the low angle scatter
channel is: LS. MS means Medium angel scatter channel and HS stands for High
angle scatter channel. By analysing the DIFF channel scattergram, the analyzer
presents the Lym%, Mon%, Eos% and Neu%. The independent WBC/Baso chan-
nel shall use a specific kind of hemolytic agent that can extract the Baso cell
specificity, so as to reserve the complete information of Baso cells.
Conduct precise and reliable WBC/Baso cell counting combined with three-an-
gle laser scattering and flow cytometry. Monocytes are after the lyse process
bigger than the lymphocytes; therefore you see them on the LS axis shown on
top of the lymphocytes. or the EOS are more complex than the Lym and there-
fore you see them on the HS-axis further right. The size of ALY is bigger than
LYM but smaller than MON. So ALY area is measured between LYM and MON.
The size of LIC is much bigger than NEU, so it will have much stronger LS signal.
It will always cluster in the area which deviated from the NEU cluster area.
3.1.6.2 Derivation of WBC-Related Parameters

Based on the DIFF scattergram and the analysis for the Lym zone, Neu zone,
Mon zone, Eos zone, Aly zone and Lic zone the analyzer can get the percentage
of lymphocytes (Lym%), the percentage of neutrophils (Neu%), the percentage
of monocytes (Mon%) the percentage of eosinophils (EOS%), as well as Atypical
Lymphocytes (ALY%) and Large Immature Cells (LIC%) and then get the number
of basophils (Bas#), the number of lymphocytes (Lym#), the number of neutro
phils (Neu#), the number of monocytes (Mon#) the number of eosinophils
(EOS#), the number of atypical lymphocytes (Aly#) and the number of large
immature cells (lic#) based on the calculation with the white blood cell count
26
obtained with the working principle of laser-based flow cytometry. The unit of
the number of cells is 109/l.
• White Blood Cell count
WBC count is the number of leukocytes measured directly by counting the leucocytes passing through
the flow chamber
• Number of Basophils (Bas#)
Bas# is the number of Basophils measured directly by counting the basophils passing through the flow
chamber
• Percentage of Basophils (BAS%)

Bas#
Bas%= x100%
WBS
• Percentage of Lymphocytes (Lym%)

Particles in Lym region of DIFF channel
Lym%= x100%
Sum of all particles in DIFF channel exept those Ghost region
• Percentage of Neutrophils (Neu%)

Particles in Neu region of DIFF channel
Neu%= x100%
• Percentage of Monocytes (Mon%)

Particles in Mon region of DIFF channel
Mon%= x100%
• Percentage of Eosinophils (EOS%)

Particles in Eos region of DIFF channel
Eos%= x100%
• Percentage of Atypical Lymphocyte

The number of granules which fall on ALY field (in DIFF channel)
ALY%= x100%
The total number of all granules except Ghost (in DIFF channel)
Note: ALY field locate in upper corner to LYM field
• Percentage of Large Immature Cells

The number of granules which fall on ALY field (in DIFF channel)
LIC%= x100%
The total number of all granules except Ghost (in DIFF channel)
Note: LIC field located just above the horizontal line of NEU field and this horizontal line was drawn
according to the granule shape of rear LS Axis.
• Number of lymphocytes (Lym#)

Lym#= WBC x Lym%
• Number of Neutrophils (Neu#)
Neu#= WBC x Neu%
• Number of Monocytes (Mon#)

Mon# = WBC x Mon%
• Number of Eosinophils (EOS#)
Eos# = WBC x Eos%
• Number of Atypical Lymphocytes

ALY# = WBC x ALY%
• Number of Large Immature Cells
LIC# = WBC x LIC%

3.1.7 HGB MEASUREMENT

HGB is determined by the colorimetric method.
3.1.7.1 Colorimetric Method

The WBC/HGB diluent is delivered to the HGB bath where it is mixed with a cer-
tain amount of lyse, which converts hemoglobin to a hemoglobin complex that
is measurable at 525 nm. An LED is mounted on one side of the bath and emits
a beam of monochromatic light with a central wavelength of 525 nm. The light
passes through the sample and is then measured by an optical sensor mounted
on the opposite side. The signal is then amplified and the voltage is measured
and compared with the blank reference reading (readings taken when there is
only diluent in the bath).
3.1.8 HGB
The HGB is calculated using the following equation and expressed in g/l.
Blank Photocurrent
HGB (g/l) = Constant x Ln ( Sample Photocurrent )
3.1.9 RBC/PLT Measurement

The analyzer detects the red blood cell count and platelet count and their vol-
ume distribution by impedance method and determines the results of related
parameters.
3.1.9.1 Electrical Impedance Method

RBCs/PLTs are counted and sized by the Electrical Impedance method. This
method is based on the measurement of changes in electrical resistance pro-
duced by a particle, which in this case is a blood cell, suspended in a conductive
diluent as it passes through an aperture of known dimensions.
An electrode is submerged in the liquid on both sides of the aperture to create

an electrical pathway. As each particle passes through the aperture, a transi-
tory change in the resistance between the electrodes is produced. This change
produces a measurable electrical pulse. The number of pulses thus generated is
equal to the number of particles that passed through the aperture.
28
Figure 9
Constant current source
Electrical Impedance method
Count bath
Front
bath
Wider pulse amplitude
Rear bath Wider pulse

width Lower pulse amplitude
Front bath
electrode
Narrower
pulse width
Rear bath
electrode
Diluent Large cell Small cell

Diluent
Aperture
Each pulse is amplified and compared to the internal reference voltage channel,
which only accepts the pulses of a certain amplitude. If the pulse generated is
above the RBC/PLT lower threshold value, it is counted as a RBC/PLT. The analyz-
er presents the RBC/PLT histogram, where the x-coordinate represents the cell
volume (fl) and the y-coordinate represents the number of the cells.
3.1.9.2 RBC
-- Red Blood Cell count
RBC (1012/l) is the number of erythrocytes measured directly by counting the
erythrocytes passing through the aperture.
-- Mean Corpuscular Volume (MCV)
Based on the RBC histogram, this analyzer calculates the MCV and expresses
the result in fl.
-- Hematocrit (HCT), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscu-
lar Hemoglobin Concentration (MCHC)
This analyzer calculates the HCT (%), MCH (pg) and MCHC (g/l) as follows,
where the RBC is expressed in 1012/l, MCV in fl and HGB in g/l.

RBC x MCV
HCT =
10
HGB
MCH =
RBC
HGB
MCHC = x 100
HCT
-- Red Blood Cell Distribution Width - Coefficient of Variation (RDW-CV)

Based on the RBC histogram, this analyzer calculates the CV (Coefficient of
Variation, %) of the erythrocyte distribution width.
-- Red Blood Cell Distribution Width - Standard Deviation ( RDW-SD)
RDW-SD (RBC Distribution Width – Standard Deviation, fl) is obtained by cal-
culating the standard deviation of the red blood cell size distribution.
3.1.9.3 PLT
-- Platelet count
PLT is measured directly by counting the platelets passing through the ap-
erture.
-- Mean Platelet Volume (MPV, fl)
Based on the PLT histogram, this analyzer calculates the MPV.
-- Platelet Distribution Width (PDW) or PDWcv
The PDW is the distribution width of the platelets. It is determined at the
20% level of peak height of the histogram
-- Plateletcrit (PCT)
This analyzer calculates the PCT as follows and expresses it in %, where the
PLT is expressed in 109/l and the MPV in fl.
PLT x MPV
PCT =
10000
30
3.1.10 MEASUREMENT PARAMETERS

The analyzer performs sample analysis for different parameters according to dif-
ferent measurement modes (CBC or CBC+DIFF).
-- In CBC+DIFF mode, the analyzer provides quantitative analysis results for
29 parameters (including 23 hematology parameters and 6 research param-
eters), 3 histograms, and 4 DIFF scattergrams (including one BASO scatter-
gram and three DIFF scattergrams).
-- In CBC mode, the analyzer provides quantitative analysis results for 13 he-
matology parameters, 3 histograms, and one BASO scattergram.
Refer to the table below for the detailed parameters of HumaCount 5D.
Table 3
Type Parameter Name Abbreviation CBC CBC+DIFF
WBC White Blood Cell count WBC * *
(15 items) Percentage of Neutrophils Neu% / *
Percentage of Lymphocytes Lym% / *
Percentage of Monocytes Mon% / *
Percentage of Eosinophils Eos% / *
Percentage of Basophils Bas% / *
Number of Neutrophils Neu# / *
Number of Lymphocytes Lym# / *
Number of Monocytes Mon# / *
Number of Eosinophils Eos# / *
Number of Basophils Bas# / *
Percentage of Abnormal ALY% (RUO) / *
Lymphocytes
Percentage of Large LIC% (RUO) / *
Immature Cells
Number of Abnormal ALY# (RUO) / *
Lymphocytes
Number of Large LIC# (RUO) / *
Immature Cells
RBC Red Blood Cell count RBC * *
(8 items) Hemoglobin Concentration HGB * *
Mean Corpuscular Volume MCV * *
Mean Corpuscular Hemoglobin MCH * *
Mean Corpuscular MCHC * *
Hemoglobin Concentration
Red Blood Cell Distribution RDW-CV * *
Width - Coefficient of Variation
Red Blood Cell Distribution RDW-SD * *
Width - Standard Deviation
Hematocrit HCT * *

PLT Platelet count PLT * *

(4 or 6 Mean Platelet Volume MPV * *
items) Platelet Distribution Width PDW * *
Plateletcrit PCT * *
Platelet-large cell ratio (for P-LCR * *
DF52, DF55 and DF56 only)
Platelet-large cell count (for P-LCC * *
DF52, DF55 and DF56 only)
Histogram White Blood Cell Histogram WBC Histogram * *
(3 items) Red Blood Cell Histogram RBC Histogram * *
Platelet Histogram PLT Histogram * *
Scatter- Differential Scattergram DIFF Scattergram / *
gram Basophils Scattergram BASO Scattergram * *
! -- “*” means the parameter is provided in the mode. “/” means the pa-
rameter is not provided.
-- ALY%, LIC%, ALY#, P-LCC, P-CCR and LIC# are parameters for research
use only (RUO), not for diagnostic use.
3.1.11 USER INTERFACE OF HUMACOUNT 5D

After the startup procedure, you will enter the user interface (Sample Analysis
as default screen). See Figure 10.
Figure 10
32
The interface can be divided into several areas as follows according to their func-
tions:
-- Menu navigation area
On the top of the screen is the menu navigation area. Once a menu button is
pressed, the system goes immediately to the corresponding screen.
-- Menu content display area
It displays the selected screen and the corresponding function buttons.
-- Error message area
Upon the occurrence of a system failure, the corresponding error message
will appear in this area. When there is more than one failure, the error mes-
sage for the latest failure will appear in this area. Click in this area, you can
deal with the failures in the pop-up dialogue box of troubleshooting help.
For more information, see chapter 11 Troubleshooting.
-- Status display area
On the lower left of the screen is the status display area where the connec-
tion status between the analyzer and the LIS system and printer status are
displayed from left to right. The icons change with the status of the main
unit, as shown in Table 4.
Table 4
Status Icon Remarks
LIS/HIS Grey icon The computer is not connected to the LIS/
Status Icon Description
status HIS.
Black icon The computer is connected to the LIS/HIS.
Print status Grey icon The external printer is not connected to the
analyzer yet.
Colour icon The external printer is connected to the
analyzer.
-- Information area of the next sample

This area displays the information about the sample ID, sample position,
blood mode (whole blood/prediluted blood) and measurement mode (CBC/
CBC+DIFF) of the next sample.
-- Current user, date and time

3.1.11.1 System Reagents

The following reagents are intended to be used with the analyzer for 5-part diff
counting, daily cleaning and other operations.
-- HC5D-Diluent (Ref.: 16450/10)
This product is intended for sample dilution and preparation of cell suspen-
sion before running the samples.
The diluent is a solution with certain ion strength and conductivity, which
can dilute the blood and form the sheath flow, providing a stable environ-
ment for blood cell counting.
Ingredients:
Sodium Chloride, Sodium Sulfate, Buffering agent; Antifungal and antibac-
terial agents.
Storage and Stability:

HC5D Diluent will be stable for 2 years when stored at 2°C to 30°C (35°F to
86°F).
If the operating environment is 15°C to 30°C (59°F to 86°F), discard opened
container after 60 days.
Applicable Analyzer:
Applicable to the HumaCount 5D hematology analyzers.
How to Use:
Restore HC5D-Diluent to the use temperature, unpack the reagent, insert
the corresponding catheter to the diluent barrel according to the colour cor-
respondence between the reagent bottle cap and the analyzer bottle cap
assembly joint, screw the bottle cap assembly, replace the reagent according
to the operator's manual of the analyzer, and then conduct the blank deter-
mination to make sure that the measured value is within the blank counting
range required in the operator's manual of the analyzer before sample test-
ing. Refer to the operator's manual of the analyzer for further information.
34
Specifications:
The product should be clear liquid without particles, sediment and flocs.
Background result: WBC≤0.2x109/l
RBC≤0.2x1012/l
HGB≤1g/l
PLT≤10x109l
Precautions:
• Do not inhale. In case of inhaling, immediately go see a doctor. Avoid skin
or eye contact. In case of skin contact, flush the affected area with plenty
of water immediately. In case of eye contact, flush the affected area with
plenty of water immediately and go see a doctor.
• Use HC5D-Diluent before the expiration date.
• If product is frozen (either partially or completely), thaw completely,
warm to room temperature and mix thoroughly by gentle inversion. Ver-
ify background results before analysing patient samples.
• Dispose of reagents, waste and consumables according to government
regulations.
• Test result may be unreliable if:
Reagent is expired or invalid
Reagent is polluted with dust from the air
Sample is not processed cleanly
Reagent is mixed or used with third party reagents.
-- HC5D CBC Lyse (Ref.: 16450/20)

This product is intended for lysing the red blood cells and white blood cell
classification.
The HC5D CBC Lyse is added to lyse the red blood cells (RBC) and react with
the released hemoglobin (HGB) for the measurement of HGB, white blood
cell count (WBC) and Basophils (BAS).
Ingredients:
Surface active agent; Buffering agent; Antifungal and antibacterial agents.


The HC5D CBC Lyse will be stable for 2 years when stored at 2°C to 30°C (35°F
to 86°F).
How to Use:
Restore HC5D CBC Lyse to the use temperature, unpack the reagent, insert
respondence between the reagent bottle cap and the analyzer bottle cap as-
sembly joint, screw the bottle cap assembly, replace the reagent according
Specifications:
The product should be clear liquid without particles, precipitate or floccule.

HGB≤1g/l
Precautions:
• Use HC5D CBC Lyse before the expiration date.
regulations.
36
-- HC5D Diff Lyse (Ref.: 16450/30)

This product is intended for lysing the red blood cells, determining the he-
moglobin, white blood cell classification and counting the total number of
white blood cells.
The HC5D Diff Lyse is added to lyse the red blood cells (RBC) and maintain the
morphology of cells for white blood cell (WBC) differential.
Ingredients:
Surface active agent; Buffering agent; Antifungal and antibacterial agents.

The HC5D Diff Lyse will be stable for 2 years when stored at 2°C to 30°C (35°F
to 86°F).
How to Use:
Restore HC5D Diff Lyse to the use temperature, unpack the reagent, insert
respondence between the reagent bottle cap and the analyzer bottle cap as-
sembly joint, screw the bottle cap assembly, replace the reagent according
Specifications:
The product should be clear liquid without particles, precipitate or floccule.

Precautions:
• Use HC5D Diff Lyse before the expiration date.
regulations.
-- HC5D-Clean (Ref.: 16450/60)

This product is intended for cleaning the fluidic system of the analyzer and
regular instrument cleaning.
The HC5D Clean is a strong alkaline solution that effectively cleans out pro-
tein stains and other particles affecting blood cell counting.
Ingredients:
Surface active agent, Sodium Hydroxide, Sodium Hypochlorite

The HC5D Diff Lyse will be stable for 2 years when stored at 2°C to 30°C (35°F
to 86°F).
38
How to Use:
Follow the instructions on the analyzer operating screen and set the un-
capped cleanser to the sample probe when required. Then press the aspirate
key to start cleanser maintenance. Refer to the operator's manual for further
information.
Specifications:
The product should be clear liquid without particles, sediment and flocs.
RBC≤0.2x1012/l
HGB≤1g/l
PLT≤10x109/l
Precautions:
• Use HC5D Clean before the expiration date.
regulations.

3.1.12 REAGENTS, CONTROLS AND CALIBRATORS

Because the analyzer, reagents, controls, and calibrators are components of the
system, system performance depends on the combined integrity of all the com-
ponents. You must only use the Human-specified reagents (see A.2 Reagents),
which are formulated specifically for the fluidic system of your analyzer in order
to achieve optimal system performance. Do not operate the analyzer using rea-
gents from multiple suppliers. Under such circumstances, the analyzer may not
achieve the performance specified in this manual and may generate unreliable
results.
All references to “reagents” in this manual refer to the reagents specifically for-
mulated for this analyzer. Each reagent package should be examined before use.
Inspect the package for signs of leakage or moisture. If there is evidence of leak-
age or improper handling, do not use the reagent.
! -- After long-distance transportation, the reagent must be allowed to

settle for more than one day before use.
-- Store and use the reagents by following the instructions for use of the
reagents.
-- When you have changed the diluent or lyses, run a background check
to see if the results meet the requirement.
-- Pay attention to the expiration dates and open-container stability of
all the reagents. Be sure not to use expired reagents.
3.1.12.1 Controls and Calibrators

-- HC5D-Control (Ref.: 16450/40)
The controls and calibrators are used for quality control and analyzer cali-
bration. The controls are dedicated whole-blood products used to verify
that the analyzer is functioning properly. They are available in low, normal,
and high levels. Daily use of all levels verifies the normal operation of the
analyzer and ensures the acquisition of reliable results.
-- HC-Calibrator (Ref.: 17400/50)

The calibrators are dedicated whole-blood products used to calibrate the
analyzer. Read and follow the instructions to use the controls and calibra-
tors. The “calibrators” and “controls” mentioned in this manual refer to
Human-specified calibrators and controls and need to be purchased from
Human or its specified agent.
40
-- Potential Biohazardous Material

For in vitro diagnostic use. Each human donor/unit used in the preparation
of HUMAN’s products has been tested, and yielded non-reactive / negative
results, according to FDA guidelines as contained in 21 CFR 610.40(a)(b).
Specifically, a sample from each donation used has been tested by FDA-li-
censed tests and found nonreactive / negative for:
1. Antibodies to human immunodeficiency virus (anti-HIV 1,2), hepatitis C

virus (anti-HCV), and antibodies to Trypanosoma cruzi (T cruzi, the causa-
tive agent of Chagas disease), and nonreactive for hepatitis B surface anti-
gen (HBsAg)
2. Nucleic acid tests (NAT) for HCV ribonucleic acid (RNA), HIV-1 RNA, HBV
deoxyribonucleic acid (DNA) and West Nile virus (WNV) RNA
3. Serologic test for syphilis

Because no test method can offer complete assurance that infectious
agents are absent, material should be handled as potentially infectious.
When handling or disposing of vials follow precautions for patient speci-
mens as specified in the OSHA Bloodborne Pathogen Rule (29 CFR Part 1910,
1030) or other equivalent biosafety procedures.
-- Performance characteristics
Assigned values of control and calibrator are presented as a Mean and
Range. The Mean is derived from replicate testing on instruments operated
and maintained according to the manufacturer’s instructions. The Range is
an estimate of variation between laboratories and also takes into account
inherent imprecision of the method and expected biological variability of
the control material. Assay values on a new lot of control should be con-
firmed before the new lot is put into routine use. Test the new lot when the
instrument is in good working order and quality control results on the old
lot are acceptable. The laboratory’s recovered mean should be within the
assay range. For greater control sensitivity each laboratory should establish
its own mean and acceptable range and periodically reevaluate the mean.
The laboratory range may include values outside of the assay range. The
user may establish assay values not listed on the Assay Sheet, if the control
is suitable for the method.

3.1.12.2 Safety Notes

The safety notes apply to the following REF numbers.
[REF] 16450/10 HC5D Diluent
[REF] 16450/20 HC5D CBC Lyse
[REF] 16450/30 HC5D Diff Lyse
[REF] 16450/40 HC5D Control
[REF] 16450/60 HC5D Clean
Hazard statements
The following hazard statements are valid for the respective REF numbers.
H411 Toxic to aquatic life with long lasting effects.
H314 Causes severe skin burns and eye damage.
Precautionary statements
The following precautionary statements apply to the following REF numbers
[REF] 16450/30 HC5D Diff Lyse
[REF] 16450/40 HC5D Control
P234 Keep only in original container.

P260 Do not breathe, dust/fume/gas/mist/vapours/spray.
P262 Do not get in eyes, on skin, or on clothing.
P281 Use personal protective equipment as required.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated
clothing. Rinse skin with water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/attention.
P401 Store in accordance with local/regional/national/international regulations.
P501 Dispose of contents/container in accordance with local/regional/national/
international regulations.
42
The following precautionary statements apply to the following REF number.

P260 Do not breathe dusts or mists.

P280 Wear protective gloves/protective clothing/eye protection/face protec-
tion.
P264 Wash thoroughly after handling.
P303+P361+P353 IF ON SKIN (or hair): Take off immediately all contaminated
clothing. Rinse skin with water/shower.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
P310 Immediately call a POISON CENTER/doctor.
P321 Specific treatment (see on this label).
P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for
breathing.
P405 Store locked up.
P501 Dispose of contents/container in accordance with local/regional/national/
international regulations.
3.1.12.3 Dangerous components

The following information about dangerous components are valid for the fol-
lowing REF numbers.
CAS: 10043-35-3 boric acid 0.1-≤ 2.5%
CAS: 1119-94-4 Dodecyltrimethylammoniumbromid 2.5-<10%
CAS: 1310-73-2 sodium hydroxide 0.5-<2%
CAS: 7681-52-9 sodium hypochlorite, solution 0.1-<0.25%
CAUTION
Do not turn on the analyzer immediately after its shutdown. Wait
at least 10 seconds before power-on to avoid damage to the ma-
chine.

! -- To ensure stable analyzer performance and accurate analysis results,

be sure to perform the Shutdown procedure to shut down the analyz-
er after it has been running continuously for 24 hours.
-- When the analyzer is running or performing other fluidics sequence,
do not force shutdown the analyzer.
-- If any error is detected during shutdown procedure, the analyzer will
return to the status before the shutdown procedure is performed, and
then activate the alarm. See chapter 11 Troubleshooting for details of
removing the error.
-- Be sure to shut down the analyzer in strict accordance with the in-
struction below.
Procedures for shutting down the analyzer are as follows:
1. Click the button on the menu screen.

The interface pops up a dialogue box as shown below.
Figure 11
2. Click Yes.
The system starts to execute the shutdown sequence and a message box
pops up showing the procedures for cleanser maintenance.
3. Follow the instructions and set the cleanser under the sample probe and
press the aspirate key on the analyzer or click Aspirate to run the cleanser
aspiration. Upon the completion of cleanser maintenance, you’ll be prompt-
ed that the cleanser maintenance is completed.
4. Place the [O/I] switch at the back of the main unit in the [O] position.
5. After shutdown, empty the waste in the waste container, and dispose it.
WARNING
Be sure to dispose reagents, waste, samples, consumables, etc. ac-
cording to local legislations and regulations.
44
3.1.13 SAMPLE COLLECTION AND HANDLING
All the samples, controls, calibrators, reagents, wastes and areas

in contact with them are potentially biohazardous. Wear proper
personal protective equipment (e.g. gloves, lab uniforms, etc.) and
follow laboratory safety procedures when handling them and the
relevant areas in the laboratory.
WARNING
Do not touch the patients’ blood sample directly.
! Note:
-- Do not re-use such disposable products as collection tubes, test tubes,
capillary tubes, etc.
-- Prepare the samples as per the procedures recommended by the rea-
gent manufacturer.
-- Be sure to use clean K2EDTA vacutainer blood collection tubes with
anticoagulant, fused silica glass/plastic test tubes, centrifugal tubes
and borosilicate glass capillary tubes.
-- Be sure to use the Human-specified disposable products including
vacutainer blood collection tube, vacutainer blood collection tubes
with anticoagulant and capillary tubes etc.
-- For the whole blood samples to be used for WBC classification or PLT
count, store them at room temperature and run them within 8 hours
after collection.
-- If you do not need the PLT, MCV and WBC differential results, you can
store the samples in a refrigerator (2°C - 8°C) for 24 hours. You need to
warm the keep samples at room temperature for at least 30 minutes
before running them.
-- Be sure to mix any sample that has been prepared for a while before
running it.

3.1.13.1 Running the Venous Whole Blood Samples

The procedure for preparing venous whole blood sample is as follows:
1. Use clean K2 or K3 EDTA (1.5~2.2 mg/ml) vacutainer blood collection tubes

with anticoagulant to collect venous blood samples.
2. Make sure the collected is not less than 80% of the draw volume of the tube.
Do not use short draws.
3. Mix the venous blood with the anticoagulant well in the tube immediately.
CAUTION
-- For vacutainer blood collection tube (12x75, cap excluded),
please make sure the volume of the whole blood sample is not
less than 0.5 ml.
-- Venous blood samples, collected in EDTA tubes in hematology
should be used according to CLSI H18-A3, within 8 hours.
3.1.13.2 Capillary Whole Blood Samples

HumaCount 5D has a dedicated capillary whole blood sample mode. A detailed
description on the how to use capillary blood samples is available on the Quick
Guide REF 16450/5. Please follow the steps described below for capillary blood
collection:
1. Dispense 480 μl of HC5D Diluent by the HC5D automatically into a bullet

tube.
2. Perform blood collection by finger prick into a 20 μl HUMAN capillary tube
(EDTA coded). After blood collection is completed, wipe away excess blood
on the outer side of the capillary by a tissue free wet tissue. Avoid any con-
tact of the tissue with the blood in the capillary tube.
3. Put the capillary into the bullet tube filled with Diluent, close the lid and
invert the sample carefully, until the suspension is homogeneous.
The capillary blood suspended in the HC5D-Diluent can be used up to 4 hours

after collection on HC5D. The HC5D diluent being dispensed in a clean unused
bullet tube can be used for capillary tube suspension up to 8 hours. After that
time, please use a new bullet tube filled with fresh HC5D-diluent.
CAUTION
Never put pressure on the skintissue next to the capillary collec-
tion tissue to avoid dilution of blood by tissue liquids.
46
3.1.13.3 Prediluted Samples

The procedure for preparing prediluted sample is as follows:
1. Click the button on the left side of the screen and enter the menu
screen as shown in Figure 12.
Figure 12
Menu Screen
2. Click the Add Diluent icon.

A prompt box will pop up on the screen as shown below.
Figure 13

3. Take a clean centrifugal tube, uncap it and present it to the sample probe
in a manner as shown in the following picture in which the probe tip is ver-
tically in contact with the bottom of the tube so as to avoid bubbles, liquid
attached to the inner wall or spatter.
4. Press the aspirate key and add the HC5D diluent (480 μl at a time) automati-
cally by the analyzer. After the diluent is added and you hear a beep, you can
remove the centrifugal tube.
5. If more portions of diluent are needed, repeat steps 3~4.
6. Add 20 μl of blood to the diluent, close the tube cap and shake the tube to
mix the sample.
7. After the prediluted sample is prepared, click Cancel to exit dispensing the
diluent.
-- Ideally you use the HUMAN capillary (REF: 16070/30) and put it together
with the blood inside the centrifuged tube. Close the tube and mix careful-
ly until all blood is mashed out the capillary and dissolved homogeneously.
Leave capillary inside.
-- You can also dispense 480 μl of diluent by pipette into the tube.
-- The prediluted sample prepared after single blood collection can be counted
twice.
-- Be sure to keep dust from the prepared diluent.
-- Be sure to run the prediluted samples within 30 minutes after the mixing.
-- Be sure to mix any sample that has been prepared for a while before running it.
-- Be sure to evaluate predilute stability based on your laboratory’s sample
population and sample collection techniques or methods.
48
-- The centrifugal tube shall be placed vertically upward, not tilted or upside
down. Otherwise, the inner wall of the tube would be stained with excessive
sample, resulting in waste. Moreover, it may cause unevenly mixed sample
and unreliable analysis results.
Figure 14
3.1.14 SAMPLE ANALYSIS

After the sample is prepared, you can perform the operations for sample analy-
sis. For details, see chapter 4 Sample Analysis.

Sample Analysis 49
4 SAMPLE ANALYSIS
4.1 Introduction
Sample analysis is the most important function of the auto hematology analyz-
er. You can get the blood cell count, HGB concentration and the 5-part classifica-
tion counting results of the white blood cells by performing the sample analysis.
The summary of sample analysis procedures are as follows:
1. Entering the sample information.

2. Running the samples.
3. Processing the analysis results.
4.2 Interface Introduction

The Sample Analysis interface is the main interface of the analyzer (Figure 15).
You can complete the operations such as entering the sample information,
performing sample analysis, reviewing/printing analysis results in the Sample
Analysis interface.
1 Figure 15
Sample analysis interface
2
1 Function buttons
2 Patient information area
3 Analysis results area
3 4 Information of the next
sample
4
50
Related descriptions:
-- Function buttons
You can perform operations such as setting the mode for the samples,
pre-entering information, reviewing previous/next records and printing.
Click and view all function buttons.
4.3 Functions of the Buttons.

-- Patient information area
It displays the patient information corresponding to the current sample.
-- Analysis results area
It displays the analysis results of the sample, including the parameter re-
sults, Flags, DIFF scattergrams, BASO scattergram and histograms (including
WBC, RBC and PLT). The system displays the analysis results of the most re-
cent run by default.
• Parameter Results
This list displays the analysis results of all the parameters of the samples.
You can compare the values in the Result column with the corresponding
Ref. Range. If the values are within the reference range, it means that
they are normal. If not, it indicates that the sample may be abnormal and
the corresponding symbols will be displayed in the Flag column.
• WBC Message
Displays the alert message regarding the WBC.
• RBC Message
Displays the alert message regarding the RBC.
• PLT Message
Displays the alert message regarding the platelet.
• DIFF
WBC DIFF scattergram in the CBC+DIFF mode. Click the scattergram,
three WBC DIFF scattergrams including LS-MS, LS-HS and HS-MS and one
BASO scattergram will bedisplayed.
• WBC
WBC distribution histogram.
• RBC
RBC distribution histogram.
• PLT
Platelet distribution histogram.
-- Information of the next sample
It displays the sample ID and analysis mode of the next sample.

Sample Analysis 51
4.4 Entering Sample Information

You can enter the worklist information of the samples to be tested before the
analysis.
! You can also enter sample/patient information after the sample analysis
is completed. For details, please refer to 8 Result Review. Detailed steps
are shown below:
1. Click the Edit Patient button in the function button area. The interface as
shown in Figure 16 will pop up on the screen.
Figure 16
Pre-entering Patient Information
2. Enter patient information with reference to the parameter description in the

following tables:
52
Parameter It means Operation

First Name First name of patient. Input in the textbox directly.
Last Name Last name of patient. Input in the textbox directly.
Patient Type Type of patient. Values: Select from the dropdown list.
-- (Null)
-- Inpatient
-- Physical Examination
-- STAT
-- Outpatient
Sample Type Type of sample for mi- Click the Sample Type drop-
croscopic examination. down list box and select the
Values: type of sample for microscopic
-- Venous blood examination.
-- Capillary
-- Cord blood
-- Blood
Med Rec. No. Medical record number of Input in the textbox directly.
patient.
Gender Gender of patient. Values: Select from the dropdown list.
-- (Null)
-- Male
-- Female
-- Not defined
Birthday Birthday of a patient. Select from the date control.
-- The input sequence of the
controls is the same with
the date format on the top
right corner of the dialogue
box. For example, if the data
format is yyyy/MM/dd, you
should input the data in the
sequence of year, month, and
date.
-- Click or to select
the date or click the textbox
to enter them directly.
-- Click to clear the current
data and re-enter the infor-
mation.

Sample Analysis 53
Age Age of a patient. Select the unit of age from the

dropdown list (Year, Month, Day
or Hour) and enter the age of the
! Note: If the Birthday is set,
the age will be displayed au-
tomatically.
patient in the textbox before
the age unit.
Ref. Group Reference group of the
sample under analysis.
Select from the dropdown list.
! Note: If the Automatically
match the customized refer-
ence group according to age and
The result is judged ac-
cording to the reference gender is set, gender and age of a
range of the reference patient will automatically match
group and the result the reference group according to
beyond the normal range the corresponding relationship
will be flagged. (No matter the reference group
Department Department receiving the Select from the dropdown list.
is selected or not). Refer to 5.4.3
patient.
Ref. Range for the setting of the
Area Ward area of patient. Input in the textbox directly.
reference group and range.
Bed No. Bed No. of inpatient. Select from the dropdown list or
input directly.
!Note: The bed No. is required to
be filled only for inpatients
!
Sampling Time Date and time when the Click the date control for the Note: The system automati-
sample is collected. settings. cally displays the current time
-- The input sequence of the as sampling time. The sampling
controls is the same with the time can be no later than the cur-
date format on the top right
rent system time.
corner of the dialogue box.
For example, if the data for-
mat is yyyy/MM/dd HH:mm,
you should input the data in
the sequence of year, month,
date, hour, and minute.
mation.
Submitter Personnel submitting the Select from the dropdown list or
sample. input directly.
54
Delivery Time Date and time when the Click the date control for the
! Note: The system automati-
cally displays the current time
as sample delivery time. The de-
sample is delivered. settings.
-- The input sequence of the
controls is the same with the
livery time can be no later than
date format on the top right
the current system time and can-
corner of the dialogue box.
not be earlier than the sampling For example, if the data for-
time. mat is yyyy/MM/dd HH:mm,
you should input the data in
the sequence of year, month,
date, hour, and minute.
mation.
Remarks Clarifications or notes. Input in the textbox directly.
3. Click Apply or OK to save the configuration.

Sample Analysis 55
4.5 Running Samples
! -- The tube (or centrifugal tube) shall be placed vertically upward, not
tilted or upside down. Otherwise, the inner wall of the tube may be
stained with excessive sample, resulting in waste. Moreover, it may
cause unevenly mixed sample and unreliable analysis results.
-- During aspiration, the tip of the probe should be kept at a certain dis-
tance from the bottom of the sample container, otherwise the accura-
cy of aspiration volume will be affected.
-- Keep the tip of the probe from contacting with the wall of the test
tube to avoid blood splashing.
-- Proper reference range shall be selected on the Setup interface before
analysis. Otherwise, the results may be flagged erroneously.
-- The default system setting for counting mode is Venous Whole Blood
(VWB)-CBC+DIFF.
-- When the analyzer is running the samples, you can switch to Review
interface to perform operations including browsing and exporting,
etc., and you can also switch to other interfaces. But all the functions
related to the fluidics sequence are not available. Take the following
steps to perform sample analysis.
-- Prepare samples as instructed by chapter 6.4 Sample Collection and Handling.

-- For details about the preparation of venous whole blood samples, see chap-
ter 3.1.13.1 Running the Venous Whole Blood Samples.
-- For details about the preparation of capillary whole blood samples, see chap-
ter 3.1.13.2 Capillary Whole Blood Samples.
-- For details about the preparation of prediluted samples, see chapter 3.1.13.3
Prediluted Samples.
4. Mix the capped tube of sample for a homogeneous specimen.
5. When the green indicator light is steady-on, click Mode & ID in Sample
Analysis interface.
A dialogue box will pop up as shown in Figure 17. The analyzer supports six
counting modes: venous whole blood (VWB)-CBC+DIFF, venous whole blood
(VWB)-CBC, capillary whole blood (CWB)-CBC+DIFF, capillary whole blood
(CWB)-CBC, Predilute(PD)-CBC+DIFF, and Predilute(PD)-CBC.
56
Figure 17
Mode & ID Settings
6. Select the blood sample mode Venous Whole Blood (VWB), Capillary Whole
Blood (CWB) or Predilute (PD) of the sample.
7. Select the measurement mode CBC or CBC+DIFF according to the actual test
case, and enter the Sample ID.
Refer to Table 5 for the description of relevant parameters.
Table 5
CBC Complete Blood Count with no differ- Selected from the
Sample Analysis
ential count for white blood cells. The radio box.
Parameter Descriptions
counting results comprise 13 parame-
ters, 3 histograms (including WBC, RBC
! Note: Letters, numbers and all

characters that can be entered
and PLT), and one BASO scattergram.
through the keyboard (including CBC+DIFF Complete Blood Count plus differential Selected from the
special characters) are allowed for count for white blood cells. The count- radio box.
the Sample ID. Chinese and other ing results comprise 23 measurement
languages (such as Japanese, Ko- parameters, 4 RUO parameters, one DIFF
rean, etc) are not supported. scattergram, one BASO scattergram, and
three histograms (including WBC, RBC
! The length of the entries rang-
es from 1 to 25 and the entries
shall not be empty.
and PLT).
Sample ID Identification number for the samples to Enter in the textbox
! The last character of a sam-

ple ID must be numeric, but a
string of “0” only is not an accept-
be run. directly.
able sample ID. 8. Click OK.

9. Remove the tube cap carefully and place the sample under the probe so that
the probe can aspirate the well-mixed sample.
10. Press the aspirate key on the analyzer to start running the sample. The sam-
ple will be automatically aspirated by the sample probe.

Sample Analysis 57
11. When you hear a beep, remove the sample tube. The analyzer will automat-
ically run the sample and the analysis status icon and analyzer indicator is
flickering in green. When the analysis is complete, the analyzer indicator re-
turns to constantly-on green.
12. Repeat steps 1~9 to run the remaining samples.
4.5.1 SOFTWARE-SWITCH FROM CBC TO C+DIFF

In case HC5D should be used only in CBC-mode and you would not like to con-
nect any HC5D-Diff-Lyse to save reagent costs. Please follow the instructions
below.
1. Use an empty and clean HC5D-Diff-Lyse bottle, fill it with HC5D-Diluent and
connect it with HC5D the same way as you use a HC5D-Diff-Lyse. In case
HC5D is used again in C-Diff mode.
2. Connect a regular HC5D-Diff-Lyse before activating the software switch.
4.6 Dealing with the Analysis Results
4.6.1 AUTOMATIC SAVING OF ANALYSIS RESULTS

This analyzer automatically saves sample results. When the maximum number
has been reached, the newest result will overwrite the oldest (up to 40.000 sam-
ples will be stored on hard drive of analyzer).
4.6.2 PARAMETER FLAGS

-- If parameter is followed by a “” or “”, it means the analysis result has
exceeded the upper or lower limit of the reference range but still within the
display range.
-- If the parameter is followed by a “?”, it means the analysis result is suspi-
cious.
-- If you see “***” instead of a result, it means the result is either invalid or be-
yond the display range. For the background test, the flags for parameters or
abnormal blood cell differential and morphology are not available.
4.6.3 FLAGS OF ABNORMAL BLOOD CELL DIFFERENTIAL OR MORPHOLOGY

The analyzer will flag abnormal or suspicious WBC, RBC and PLT according to
the scattergrams and histograms. The flag information is defined in the table
below.
58
Table 6
Flag Type Flag information
WBC Abnormal Leucocytosis
Flags of abnormal blood cell
Leucopenia
differential or morphology
Neutrophilia
Neutropenia
Lymphocytosis
Lymphopenia
Monocytosis
Eosinophilia
Basophilia
Suspicious WBC abnormal
Abnor. WBC scattergram
Abnor. WBC histogram
Left Shift?
Immature Cell?
RBC Lyse Resistant?
Abn./Atypical Lym?
Abnormal WBC Channel
Abnormal DIFF Channel
RBC/HGB Abnormal Erythrocytosis
Anisocytosis
Macrocytosis
Microcytosis
Anemia
Hypochromia
Suspicious Abnor. RBC Distr.
Dimorphologic
Iron Deficiency?
HGB Abnor./Interfere?
RBC Clump?
Abnormal RBC Channel
Abnormal HGB Channel
PLT Abnormal Thrombocytosis
Thrombopenia
Suspicious Abnor. PLT Distr.
PLT Clump?
The system shows flags for abnormal or suspicious items in different samples
and measurement modes in accordance with the impact of the abnormal or sus-
picious WBC, RBC or PLT items on the results of the parameters. The correlation
is shown in the following table:

Sample Analysis 59
Type Flag Whole Blood Predilute (PD) Table 7

CBC + CBC +
CBC CBC Flags for abnormal or suspicious
DIFF DIFF
items in different samples and
WBC WBC abnormal?    
measurement modes
RBC Lyse Resistant?    
Abnor. WBC scattergram    
Abnor. WBC histogram    
Left Shift?    
Immature Cell?    
Abn./Atypical Lym?    
Leucocytosis    
Leucopenia    
Neutrophilia    
Neutropenia    
Lymphocytosis    
Lymphopenia    
Monocytosis    
Eosinophilia    
Basophilia    
Abnormal WBC Channel    
Abnormal DIFF Channel    
RBC/HGB Dimorphologic    
HGB Abnor./Interfere?    
Anisocytosis    
Microcytosis    
Macrocytosis    
Erythrocytosis    
Anemia    
Hypochromia    
Abnor. RBC Distr.    
Iron Deficiency?    
RBC Clump?    
Abnormal RBC Channel    
Abnormal HGB Channel    
PLT PLT Clump?    
Thrombocytosis    
Thrombopenia    
Abnor. PLT Distr.    
-- “” indicates that flags will be displayed in the mode.”” indicates that flags
will not be displayed in the mode.
-- When the PLT value is less than 100×109/l, a manual count by the micro-
scope is recommended.
60
4.7 Functions of the Buttons
4.7.1 PREVIOUS/NEXT
Click Previous, and the screen will display the sample analysis results prior to
the current one.
Click Next, and the screen will display the sample analysis results after the cur-
rent one.
4.7.2 MODE & ID

Click Mode&ID to set the sample mode and measurement mode during the
sample analysis. See chapter 4.5 Running Samples.
4.7.3 VALIDATE/CANCEL VALIDATION

After running sample, you can click Validate to validate the sample. After vali-
dating, the button will replaced by Cancel Validation. After validating, you can
not edit the sample/patient information and the result. If the current sample
has been validated, the sample validation can be cancelled by clicking Cancel
Validation. After cancelling the validation, you can edit the sample/patient in-
formation and the result.
4.7.4 PRINT
You can click Print to print the report of the sample result.
4.7.5 PATIENT INFORMATION

You can browse and edit the patient information of the selected sample in the
Sample Analysis interface. The operation procedures are as shown below:

Sample Analysis 61
1. Click Edit Patient to enter the patient information setting interface as shown
in Figure 18.
Figure 18
Patient Information
2. Enter patient information with reference to the parameter description in

Table 8.
Parameter Meaning Operation Table 8

Sample ID Number of the select- It will be displayed automatically, and
Parameter Description
ed sample. you can modify it manually.
of Patient Information
Patient Type Type of patient. Values: Select from the dropdown list.
-- Inpatient
-- Physical Examina-
tion
-- STAT
-- Outpatient
Sample Type Type of selected sample. Select from the dropdown list.
-- Venous blood
-- Capillary
-- Cord blood
-- Blood
Med Rec. No. Med Rec. No. of patient. Input in the textbox directly.
62
Gender Gender of patient. Select from the dropdown list.

Values:
-- (Null)
-- Male
-- Female
-- Not defined
Birthday Birthday of a patient. Select from the date control.
-- The input sequence of the controls
is the same with the date format on
the top right corner of the dialogue
box. For example, if the data format
is yyyy/MM/dd, you should input
the data in the sequence of year,
month, and date.
-- Click or to select a date
and time or enter the information
in the textbox directly.
-- Click to clear the current data
and re-enter the information.
Age Age of a patient. Select the unit of age from the drop-
down list (Year, Month, Day or Hour)
and enter the age of the patient in the
textbox before the age unit.
Ref. Group Reference group of Select from the dropdown list.
the sample under Note:
analysis. -- If the Automatically match the cus-
The result is judged tomized reference group according
according to the ref- to age and gender is set, gender
erence range of the and age of a patient will automat-
reference group and ically match the reference group
the result beyond the according to the corresponding re-
normal range will be lationship (No matter the reference
flagged. group is selected or not).
-- Refer to chapter 7.3.4.11 Ref. Range
for the setting of the reference
group and range.
Department Department receiving Select from the dropdown list.
the patient.
Bed No. Bed No. of inpatient. Select from the dropdown list or input
directly.
Note:
The bed No. is required to be filled only
for inpatients.

Sample Analysis 63
Sampling Date and time when Click the date control for the settings.
Time the sample is collect- -- The input sequence of the controls
ed. is the same with the date format on
the top right corner of the dialogue
box. For example, if the data format
is yyyy/MM/dd HH:mm, you should
input the data in the sequence of
year, month, date, hour, and min-
ute.
Note:
The sampling time can be no later than
the current system time.
Submitter Personnel submitting Select from the dropdown list or input
the sample. directly.
Mode & ID Counting mode of You do not need to enter it and it will
the selected sample. be displayed automatically.
The format is blood
sample mode-meas-
urement mode.
Delivery Date and time when Click the date control for the settings.
Time the sample is deliv- -- The input sequence of the controls
ered. is the same with the date format
on the top right corner of the dia-
logue box. For example, if the data
format is yyyy/MM/dd HH:mm,
you should input the data in the se-
quence of year, month, date, hour,
and minute.
Note:
The delivery time can be no later than
the current system time and cannot be
earlier than the sampling time.
Operator Personnel running the You do not need to enter it and it will
sample. be displayed automatically.
64
Run Time Time when the sam- You do not need to enter it and it will
ple is run. be displayed automatically.
Approver Personnel validating This parameter will be automatically
the sample. displayed after the sample is validated.
Report Time The date and time when This parameter will be automatically
the report is printed displayed after the report is printed.
for the first time.
Diagnosis Suspected diagnosis Input in the textbox directly.
information.
3. Click Apply or OK to save the settings.
4.7.6 CUSTOMIZED PARAMETERS

You can browse and edit the customized parameters results of the selected sam-
ple in the Sample Analysis interface. The procedures are shown as below:
1. Click Custom Para. to enter the customized parameters setting interface as

shown in Figure 19.
Figure 19
Customized Parameters
2. Click the cell corresponding to its Value column of the parameter, and en-
ter the value. If the unit and reference range of parameters have been set
in the Setup > Parameter >Custom Para. interface, the corresponding unit
and range (lower limit~upper limit) will be displayed in this tab. When both
the value and range of parameters are numbers, and the number is out of
the reference range, the relevant mark  or  will be displayed in the Flag
column. Please refer to chapter 4.7.6 Customized Parameters for customized
parameters settings.

Sample Analysis 65
4.7.7 MICROSCOPIC EXAM. PARAMETERS

You can perform the microscopic exam. settings as per the following steps.
Click Microscopic Exam. Para.

The microscopic examination parameters interface as shown in Figure 20 will
pop up on the screen:
Figure 20
Adding a New Microscopic
Exam. Parameter
Refer to Table 9 for parameter description and operation methods regarding the
microscopic examination.
Parameter It means Operation Table 9

Sample Type Type of sample Click the Sample Type dropdown list
Microscopic Exam. Parameters
for microscopic box and select the type of sample for
examination. microscopic examination.
-- Venous blood
-- Capillary
-- Cord blood
-- Blood
Exam. Time Time of Click the Exam. Time combo box and
microscopic select the time and date for the mi-
examination. croscopic examination.
Enter the morphology information for
Microscopic Description of
WBC, RBC and PLT respectively into
Description cells morphology.
the multi-line textbox.
66
4.7.8 COMMUNICATION
You can transmit the current sample data (except the background sample) to
the LIS/HIS system in the Sample Analysis interface.
1. Click to unfold all function buttons.

2. Click Comm.
4.7.9 EDIT RESULT

-- You can not edit the results of validated samples.
-- You can not edit the results of the background.
-- In the CBC mode, only the results of the test parameters are available,
the results concerning the percentage of the WBC diff parameters are not
available.
You can edit the parameter result of the selected sample as per the following
steps.

2. Click Edit Result.
The Edit Result dialogue box will pop up on the screen as shown in Figure 21.
Figure 21
Editing Parameter Result
3. Modify the counting results of the corresponding sample parameters.

Sample Analysis 67
4. Click Apply or OK to save the changes.

If the sum of the percentage of the diff parameters is not equal to 100.00% or
the WBC value is invalid after modification, the system will prompt in a mes-
sage box that the entered value is invalid. Please re-enter after confirmation.
If the result of one parameter is modified, then the result of other related pa-
rameter(s) will be changed accordingly and the high or low/suspicious flags
will also be updated.
! The result of the parameter that you modified manually will be flagged
with an M. If any parameter result is then changed due to the one that
you modified manually, it will be flagged with an m.
! --
--
1.
Validated samples are not allowed to be deleted.
The common user has no access to delete the sample records.
Click to unfold all function buttons.
2. Click Delete, and then click Yes in the pop-up dialogue box to delete
the sample:
Figure 22
Delete Sample Records
68

Result Review 69
5 RESULT REVIEW
5.1 Introduction
Upon the completion of each sample analysis, the analyzer will automatically
save the sample information, result data, flag messages, histograms and scat-
tergrams to the Review Database. In the Review Interface, you can browse the
saved sample information, result data, flag messages, histograms and scatter-
grams, and can search, compare or export the saved sample information.
5.2 Interface Introduction

You can browse, search, compare, print, and export the existing results in the
Review interface. Click Review to enter the sample review interface.
See Figure 23.
1 Figure 23
Review
1 Function buttons
2 Result list
3 Direction button
2
4 Current page/Total pages
5 Sequence Number/ Total
number of results
Interface Description:
-- Result list: You can browse detailed sample records.
-- Function buttons: You can perform the operations such as comparing or
searching the sample results, deleting and viewing the Run Charts, export-
ing and printing reports.
70
-- Direction button: If you click different direction buttons, the list will move
toward the corresponding directions.
• From left to right, it indicates in sequence: The first column, moving to
the left page, moving to the right page, and the last column.
• From top to bottom, it indicates in sequence: The first page, the previous
page, the next page, and the last page.
5.3 Sample List

The review interface shows a list of the analyzed samples, which contains the
sample number, status, mode and results of various parameters and other in-
formation.
Click a sample or multiple samples in the list area, then you perform operations
such as exporting in batch for the selected samples. To cancel the selection, click
the selected samples again.
5.4 Functions of the Buttons
5.4.1 PRINT
Click Print to print the result report of the selected sample.
5.4.2 DELETE
-- Validated samples are not allowed to be deleted.
-- The common user has no access to delete the sample records.
1. Select one or several sample records to be deleted.
2. Click Delete.
A prompt box will pop up on the screen as shown below.
Figure 24
Delete Sample Records

Result Review 71
3. Select one or several sample records to be deleted according to the actual

situation.
• Selected Records: The sample results shown on the highlighted page.
• Samples on current page: Results of all the samples shown on the current
page.
4. Click OK to delete the selected record(s).
5.4.3 EXPORT
The operator can export the sample data to the USB flash disk for backup. There
are two ways of exporting the sample data: Exporting selected records and ex-
porting records of specified dates.
-- Export Selected Records
• Insert a USB flash disk in the USB interface on the analyzer.
• Select records to be backed up, and click Export.
As shown in the following figure, the export range of the system is
Selected Records by default.
Figure 25
Export Selected Records
• Select the content to be exported according to the actual demand. Con-

tent available for export includes: Patient Info., Sample Info., Graphs and
Flags, Custom Para., RUO Parameters.
• Click OK.
72
• Select the data export path in the popup dialogue box, enter the backup
file name, and click Save.
• The file will be exported to the root directory of the USB flash disk
(/udisk/sda1) and named in the format of SampleInfo_yyyyMMdd_
hhmmss.csv. Among which, yyyyMMdd_hhmmss means data export
year, month, date, hour, minute, and second.
Figure 26
-- Click Save.
The system pops up a dialogue box as shown below to indicate that the data
export is successful.
Figure 27
-- Export Records of the Specified Dates

• Insert a USB flash disk in the USB interface on the analyzer.
• Click Export.
• Select Records of the Specified Dates and set the run date range of sam-
ple in the two date textboxes. See Figure 28.

Result Review 73
Figure 28
Export Records of the
Specified Dates
-- Select the content to be exported according to the actual demand. Content

available for export includes: Patient Info., Sample Info., Graphs and Flags,
Custom Para., RUO Parameters.
-- Click OK.
-- Select the data export path in the popup dialogue box, enter the backup file
name, and click Save.
The file will be exported to the root directory of the USB flash disk (/udisk/
sda1) and named in the format of SampleInfo_yyyyMMdd_hhmmss.csv.
Among which, yyyyMMdd_hhmmss means data export year, month, date,
hour, minute, and second.
-- Click Export.
The system pops up a dialogue box as shown below to indicate that the data
export is successful.
Figure 29
74
5.4.4 Edit Result

-- You cannot edit the results of validated samples.
-- Background result cannot be edited!
-- In the CBC mode, only the results of the test parameters are available, the
results concerning the percentage of the WBC diff parameters are not avail-
able. You can edit the parameter result of the selected sample as per the
following steps.
1. Select a row of record from the result list and click the Edit Result button.
The Edit Result dialogue box will pop up on the screen as shown in Figure 30.
Figure 30
Editing Parameter Result
2. Modify the counting results of the corresponding sample parameters.

3. Click Apply or OK to save the changes. If the sum of the percentage of the diff
parameters is not equal to 100.00% or the WBC value is invalid after modi-
fication, the system will prompt in a message box that the entered value is
invalid. Please re-enter after confirmation. If the result of one parameter is
modified, then the result of other related parameter(s) will be changed ac-
cordingly and the high or low/suspicious flags will also be updated.
5.4.5 PATIENT INFO.

You can browse and edit sample/patient information after the sample analysis
is completed. Detailed steps are shown below:
1. Click Patient Info

The interface as shown in Figure 31 will pop up on the screen.

Result Review 75
Figure 31
Patient Info
2. Enter patient information with reference to the parameter description in

Table 10.
Parameter It means Operation Table 10

Sample ID Number of the select- It will be displayed automatically,
Parameter Description
ed sample. and you can modify it manually.
Patient Type Type of patient. Val- Select from the dropdown list.
ues:
-- Inpatient
-- Physical Examina-
tion
-- STAT
-- Outpatient
Sample Type Type of selected Select from the dropdown list.
sample.
-- Venous blood
-- Capillary
-- Cord blood
-- Blood
Med Rec. No. Med Rec. No. of pa- Input in the textbox directly.
tient.
76
Gender Gender of patient. Select from the dropdown list.

Values:
-- (Null)
-- Male
-- Female
-- Not defined
Birthday Birthday of a patient.Select from the date control.
-- The input sequence of the con-
trols is the same with the date
format on the top right corner of
the dialogue box. For example,
if the data format is yyyy/MM/
dd, you should input the data in
the sequence of year, month, and
date.
-- Click or to select a
date and time or enter the infor-
mation in the textbox directly.
Age Age of a patient. Select the unit of age from the drop-
down list (Year, Month, Day or Hour)
and enter the age of the patient in
the textbox before the age unit.
Ref. Group Reference group of Select from the dropdown list.
the sample under
analysis.
!
Note:
The result is judged -- If the Automatically match the

customized reference group ac-
according to the ref-
erence range of the cording to age and gender is set,
reference group and gender and age of a patient will
the result beyond the automatically match the ref-
normal range will be erence group according to the
flagged. corresponding relationship (No
matter the reference group is se-
lected or not).
-- Refer to chapter 7.3.4.11 Ref. Ran-
ge for the setting of the reference
group and range.
Department Department receiving Select from the dropdown list.
the patient.

Result Review 77
Bed No. Bed No. of inpatient. Input in the textbox directly.
!
Note: The bed No. is required to
be filled only for inpatients.
Sampling Time Date and time when Click the date control for the set-
the sample is collect- tings.
ed. -- The input sequence of the con-
date.
! Note: The sampling time can be

no later than the current system
time.
Submitter Personnel submitting Select from the dropdown list or in-

the sample. put directly.
Mode & ID Counting mode of You do not need to enter it and it will
the selected sample. be displayed automatically.
The format is blood
sample mode-meas-
urement mode.
78
Delivery Time Date and time when Click the date control for the set-
the sample is deliv- tings.
ered. -- The input sequence of the con-
date.
! Note:
The delivery time can be no later
than the current system time and
cannot be earlier than the sampling
time.
Operator Personnel running the You do not need to enter it and it will
sample. be displayed automatically.
Run Time Time when the sam- You do not need to enter it and it will
ple is run. be displayed automatically.
Approver Personnel validating This parameter will be automatically
the sample. displayed after the sample is validat-
ed.
Report Time The date and time This parameter will be automatically
when the report is displayed after the report is printed.
printed for the first
time.
Diagnosis Suspected diagnosis Input in the textbox directly.
information.
Click Apply or OK to save the configuration.

Result Review 79
5.4.6 QUERY
You can view the test results of a patient within a certain test date range by
entering the query conditions. The procedures are shown as below:
1. Click the Query button to enter the multi-conditional query dialogue box as
shown below.
Figure 32
Query Conditions
2. Determine the query conditions as needed.

For the specific parameter description, see Table 11.
Parameter It means Operation Description Table 11

Sample ID Sample ID to be queried. Input in the textbox directly.
Parameter Description of Query
Name Name of patient. Input in the textbox directly.
Conditions
Med Rec. No. Med Rec. No. of patient. Input in the textbox directly.
Para. Parameter and its Select a parameter from the first
range to be queried. dropdown list,and a comparison
symbol (≥, >, ≤, <, =) from the second
dropdown list, then input a value in
the textbox. For example, if you se-
lect WBC and >, then input 3 in the
textbox. The sample results which
RBC value is greater than 3.0×1012/l
will be queried and displayed.
Run Date Test date range of Select the starting and ending dates
sample. of the sample test in the two data
controls successively.
Sample status Status of validation, Please choose according to the ac-
printing or communi- tual situation.
cation of the sample. The default value is Not Validated.
-- Not Validated
-- Not Printed
-- Not Transmitted
80
! -- Auto select checked by default indicates that the query result is being
selected (with a blue background colour). If it’s unchecked, the query
result will remain on a white background colour.
-- Click All Samples to close the current window, display all the samples
again and restore all the filter conditions to the default values.
3. Click Query.
The system will display all the query results which meet the conditions.
5.4.7 RESULTS
In the Review interface, you can click Results to browse the selected sample re-
sults, parameter results and flag messages. The procedures are shown as below:
1. Select a result to review in results interface.
3. Click Results to enter the results interface of the selected sample. In the Re-
sults interface, you can view sample information such as parameter results,
graph results and flag messages. In addition, you can also print the analysis
report.
Figure 33

Result Review 81
5.4.8 MICROSCOPIC EXAM. PARAMETERS

You can perform the microscopic examination settings as per the following
steps.
1. Click Microscopic Exam. Para. The microscopic examination parameters in-
terface as shown in Figure 34 will pop up on the screen.
Figure 34
Exam. Parameter
2. Set the microscopic examination parameters by referring to Table 12.

82
Table 12
Sample Type Type of sample for Click the Sample Type dropdown
Microscopic Exam. Parameters
microscopic examination. list box and select the type of sam-
-- Venous blood ple for microscopic examination.
-- Capillary
-- Cord blood
-- Blood
Exam. Time Time of microscopic Click the date control for the
examination. settings.
-- The input sequence of the con-
format on the top right corner
of the dialogue box. For exam-
ple, if the data format is yyyy/
MM/dd, you should input the
data in the sequence of year,
month, and date.
a date and time or enter the
information in the textbox di-
rectly.
data and re-enter the informa-
tion.
! Note:
The Microscopic exam. time can
be no later than the current sys-
tem time.
Microscopic Description of cells Enter the morphology information
Description morphology. for cells into the multi-line text-
box.

Result Review 83
5.4.9 CUSTOMIZED PARAMETERS

You can browse and edit the customized parameters results of the selected sam-
ple in the Review interface. The procedures are shown as below:
1. Select one sample.
3. Click Custom Para. to enter the customized parameters setting interface as
shown in Figure 35.
Figure 35
4. Click the cell corresponding to its Value column of the parameter, and
enter the value. If the unit and reference range of parameters have been
set in the Setup > Parameter > Custom Para. interface, the correspond-
ing unit and range (lower limit~upper limit) will be displayed in this tab.
When both the value and range of parameters are numbers, and the number
is out of the reference range, the relevant mark  or  will be displayed
in the Flag column. Please refer to chapter 4.7.6 Customized Parameters for
customized parameters settings.
84
5.4.10 RUN CHART

Operators can check and review run charts of sample parameter results in the
database. There are three view modes: Selected samples, samples on current
page and samples on specified run dates.
-- View the run chart of the selected sample (default)
• Check no fewer than three sample records.
• Click to unfold all function buttons.
• Click Run Chart.
The system pops up a dialogue box as shown below.

Figure 36
Viewing the Run Chart
of the Selected Sample
-- Click OK.
The screen will show the parameter result run chart of the selected sample.
See Figure 37.
Figure 37
Run Chart
-- View the run chart of samples on current page

• Click on the current page to unfold all function buttons.
• Click the Run Chart button and select Samples on current page in the
pop-up dialogue box. See Figure 38.

Result Review 85
Figure 38
Viewing the Run Chart of Samples
on the Current Page
• Click OK.
The screen will show the parameter result run chart of the selected sample.
-- View the run chart of samples on specified run dates

• Click to unfold all function buttons.
• Click the Run Chart button, and select Run Date in the pop-up dialogue
box. See Figure 39.
Figure 39
Viewing the Run Chart of Samples
on Specified Run Dates
• Click the date edit box, set a date range in the pop-up dialogue box, then
click OK.
Figure 40
86
The input sequence of the controls is the same with the date format on
the top right corner of the dialogue box. For example, if the data for-
mat is yyyy/MM/dd, you should input the data in the sequence of year,
month, and date.
Click or to select a date and time or enter the information in
the textbox directly.
Click Cancel to keep the selected run date.
• Click OK. The screen will show the parameter result run chart of the se-
lected sample.

Daily Operations 87
6 DAILY OPERATIONS
Preparation before
the operation

Startup

Daily Quality
Control

Sample Collection
and Handling

Sample Analysis

Shutdown
6.1 Pre-operation Preparation

Perform the following checks before turning on the analyzer.
-- Waste container
Check and make sure the waste container is empty.
-- Fluidic tubing and power connections
Check and make sure the reagents and waste tubing are properly connected
and not bent.
Check and make sure the power cord of the analyzer is properly plugged into
the power outlet.
-- Printer (Optional)
Check and make sure enough paper is installed.
Check and make sure the power cord of the printer is properly plugged into
power outlet, and the printer is properly connected to the peripheral com-
puter.
-- Network Cable (Optional)
Check and make sure the network cable is properly connected to the ana-
lyzer.
88
6.2 Startup
This section introduces the operations related to the startup of the analyzer.
Note:
! -- If you failed to start the analyzer continuously, please contact Human

customer service department or your local agent immediately.
-- After startup, please make sure the data/time displayed on the screen
is correct.
1. Place the power switch at the back of the analyzer in the [I] position. The
power indicator light will be on.
2. Check the indicator light on the analyzer.
If the indicator light is on, it indicates the analyzer has been started up. The
analyzer will perform self-test and initialization in sequence. The whole pro-
cess will last for 4 to 10 minutes. (Time needed for initializing the fluidic
systems depends on how the analyzer was previously shut down.)
3. Enter the correct user name and password in the Login message box. See
Figure 41.
Figure 41
Login
The initial user name and password of administrator are admin, which was
set by service engineer.
1 to 12 digits of numeric characters can be entered for the user name and
the password. No Chinese characters are allowed.
4. Click OK to enter the user interface.

The system will display the Sample Analysis screen by default and display the
test result of the background when the analyzer is started.

Daily Operations 89
! Note:
-- The background test is designed for detecting particle interference
and electrical interference. For the background reference range of
each parameter, please see A.4.2 Normal Background.
-- The sample ID for the background test is background.
-- If the background results exceed the Ref. Range for the first time dur-
ing fluidics initialization, the analyzer will run the background test one
more time.
-- Running a test when there is a Background abnormal, you would ob-
tain an unreliable testing result.
-- If any error is detected during initialization (e.g. the background re-
sults exceed the Ref. Range), the analyzer will activate the alarm. For
details, see chapter 11 Troubleshooting.
-- To lock or switch a user, click on the menu screen and click Yes on the
pop-up dialogue box. The system will return to the login dialogue box.
Enter the user name and password, click , then you can log in again or
log in the software interface with another user identity.
6.3 Daily Quality Control

To ensure reliable analysis results, conduct daily QC analysis on the analyzer be-
fore running samples. For details, see chapter 7.1 Quality Control.
90
6.4 Sample Collection and Handling
6.4.1 SAMPLE ANALYSIS

After the sample is prepared, you can perform the operations for sample analy-
sis. For details, see chapter 4 Sample Analysis.
6.4.2 INTERFERING SUBSTANCES

The following substances can interfere with parameter measurement and alter-
nate measurement procedures may be required.
Table 13
Parameter Interference
WBC > 5 NRBCs/100 WBCs, PLT clumps/ large PLTs
RBC WBC Count >75.0 x 103/µl
MCV WBC Count >75.0 x 103/µl
PLT PLT clumps/ large PLTs
Hemoglobin WBC count > 75.0 x 103 /ul, Lipids > 280 g/dl
Differential > NRBCs/ 100 WBCs, PLT clumps/ large PLTs

Advanced Operation 91
7 ADVANCED OPERATION
7.1 Quality Control

Quality Control (QC) consists of strategies and procedures that measure the pre-
cision and stability of the analyzer. The results imply the reliability of the sample
results. QC involves measuring materials with known, stable characteristics at
frequent intervals.
Analysis of the results with statistical methods allows the inference that sample
results are reliable. HUMAN recommends running the QC program on a daily
basis with low, normal and high level controls. A new lot of controls should be
analyzed in parallel with the current lot prior to their Exp. dates. This may be
accomplished by running the new lot of controls twice a day for five days using
any empty QC file.
-- You should only use the HUMAN-specified controls and reagents. Store and
use the controls and reagents by following the instructions for use of the
controls and reagents.
-- Controls beyond their Exp. date shall not be used. Controls (similar to stand-
ard blood samples) must be well mixed before use.
-- General users only have the access for browsing and executing the QC
analysis.
7.1.1 L-J QC OVERVIEW

You can set the QC information by setting the QC file before performing the QC
analysis. Each QC file can be assigned with one Lot number for high, normal and
low level controls. Each QC file can store up to 500 QC results. When there are
more than 500 QC results, the new QC results will overwrite the oldest results in
sequence. In the L-J quality control, quality control can be applied to 23 parame-
ters. All the samples, controls, calibrators, reagents, wastes and areas in contact
with them are potentially biohazardous. Wear proper personal protective equip-
ment (e.g. gloves, lab uniforms, etc.) and follow laboratory safety procedures
when handling them and the relevant areas in the laboratory.
7.1.2 QC SETTINGS
Before running a new batch of controls, you need to assign a QC file to each batch
of controls. You can complete the QC settings by setting QC information in the
QC files. Only users with administrator-level access can edit the L-J settings.
92
7.1.2.1 Entering QC Information

The administrator can set the QC files by operations such as Copy, New, and Edit.
Detailed steps are shown below:
1. Click QC to access the QC interface.

2. Click QC Settings to enter the QC Settings interface. See Figure 42.
Figure 42
L-J Quality Control
3. Click the New button, or select a QC file (Existing/Total is 0/500) without

QC counting results and click the Edit button. The interface as shown in
Figure 43 will pop up on the screen.
Entering QC Information (Target values), see Figure 43.

You can type in the target values according to the target value sheet of the con-
trol material. Alternatively you can read the 2D barcode on the assay value sheet
(optional 2D barcode scanner (Ref.: 16430/11)) and automatically upload all tar-
get values into the analyzer. Another option is to upload the target values by a
USB flash drive.

Figure 43
Entering QC Information
(Target values)
You can also select the QC file of which data has been set and then click Copy,
and edit the content based on the original data. Set related information of the
controls with reference to Table 14.
Parameter Parameter Description Operation Description Table 14

File No. QC file No.. The system pro- Read only.
File Information
vides 60 QC files in total for
users to set the parameters.
Lot No. Lot number of controls. Enter into the textbox directly.
! Note:
The lot No. can not be empty
and up to 16 digits can be en-
tered. You can enter characters,
numbers, letters and special
characters, but no Chinese char-
acters are allowed.
Level Level of the controls, includ- Select from the dropdown list.
ing 3 levels, i.e. High, Normal
and Low.
Exp. Date Exp. date of the controls. The default Exp. Date is the cur-
rent system date and needs to be
changed to the actual Exp. date
of the controls.
QC Mode QC mode of the controls, in- Select from the dropdown list.
cluding Whole Blood-DIFF
and Predilute-DIFF.
94
QC Sam- Number of the QC sample Enter into the textbox directly.

ple ID -- Users need to set the num-
ber of the controls here if
he/she is used to perform-
! Note:
-- Letters, numbers and all char-
acters that can be entered
ing the analysis with the
through the keyboard (in-
controls placed among the
cluding special characters)
daily samples. See chap-
are allowed for the Sample ID.
ter 7.1.3.1 Completing QC
Chinese and other languag-
Analysis in the Sample Ana-
es (such as Japanese, Korean,
lysis Interface.
etc) are not supported.
-- If the user performs the
-- The length of the entries rang-
analysis in the QC Analysis
es from 1 to 25 and the entries
interface, the ID cannot be
shall not be empty.
entered.
-- The last character of a sam-
ple ID must be numeric, but a
string of “0” only is not an ac-
ceptable sample ID.
Target Target of the QC Enter the targets in the cell corre-
parameter. sponding to the expected QC pa-
rameter according to the control
target list with the correspond-
ing lot No.
Limits (#) Limits (#) of the QC Enter the limits in the cell corre-
parameter. sponding to the expected QC pa-
rameter according to the control
target list with the correspond-
ing lot No.
! Note:
You can click Set Limits to set
the display form of the limits or
the calculation method of the
limits among the preset values.
-- By SD: the limits displays in
form of absolute value. Click
2SD or 3SD to select either
double or triple standard devi-
ation to be the limits.
-- By CV: the limits displays in
form of percentage. Click 2CV
or 3CV to select either double
or triple coefficient of varia-
tion to be the limits.

In use Set if you want to specify the It’s unchecked by default. Set the
QC sample ID in the selected parameter according to the actu-
file so that you can run the QC al situation.
sample in the interface other
than the QC interface.
-- If it’s checked, you can run
the sample with the corre-
sponding sample ID in any
interface and the system
will run the QC analysis for
this sample.
-- If it’s not checked, you can
only run the QC sample in
the QC interface.
Existing/ The existing data and total QC Read only.
Total results in the current QC file.
Up to 500 QC results can be
saved for each QC file.
4. According to the target list of the corresponding lot No., enter the target val-
ue and limits into the textboxes of the parameters to be included in the QC
run.
5. Click the Save button to save all the settings of the QC.
7.1.2.2 Deleting QC File

If you want to delete QC files which will not be used any more, please take the
following steps:
2. Click QC Settings to enter the QC Settings interface.
3. Select the QC file to be deleted, and click Delete.
Figure 44
4. Click Yes.
All selected QC files together with their QC results will be completely deleted.
96
7.1.3 QUALITY CONTROL ANALYSIS

After completing the QC settings, you can choose one of the following two
modes according to the selected QC mode to run the quality control samples.
-- Completing QC analysis in the QC Analysis interface
-- Completing QC analysis in the Sample Analysis interface
CAUTION
-- Running quality controls in presence of errors may lead to in-
correct analysis results. If you see the error alarms when run-
ning the quality controls, please stop and resume the analysis
until the errors are removed.
-- Do not re-use such disposable products as collection tubes, test
tubes, capillary tubes, etc.
-- Sample clump may lead to incorrect analysis results. Check if
clump exists before running the controls; if it does, handle it as
per the related laboratory procedures.
! Note:
-- You should only use the Human-specified controls and reagents. Store
and use the controls and reagents as instructed by instructions for use
of the controls and reagents. Using other controls may lead to incor-
rect QC results.
-- Before being used for analysis mix gently the controls that have been
settled for a while according to the instruction of controls.
-- Be sure to use the Human-specified disposable products including
-- If the blood-sample mode is Predilute, then a reminder of predilute
counting will pop up if the user presses the aspirate key to perform the
counting. To close the prompt, please refer to Auxiliary Settings.
7.1.3.1 Completing QC Analysis in the QC Analysis Interface
All the samples, controls, calibrators, reagents, wastes and areas

in contact with them are potentially biohazardous. Wear proper
personal protective equipment (e.g. gloves, lab uniforms, etc.) and
follow laboratory safety procedures when handling them and the
relevant areas in the laboratory.

WARNING
-- The sample probe (needle) is sharp and potentially biohazard-
ous. Exercise caution to avoid contact with the probe when
working around it.
-- The sample may spill from the unclosed collection tubes and
cause biohazard. Exercise caution to the unclosed collection
tubes.
-- Collection tubes broken may cause personal injury and/or bio-
hazard. Be sure to place the collection tubes in the right adapter
before running, otherwise, the collection tubes may be broken
and cause biohazard.
-- Keep your clothes, hairs and hands away from the moving parts
to avoid injury.
-- Reagents can be irritating to the eyes, skin, and mucosa. Wear
proper personal protective equipment (e.g. gloves, lab uniforms,
etc.) and follow laboratory safety procedures when handling
them in the laboratory.
-- If the reagent accidentally comes in contact with your skin,
wash it off immediately with plenty of water and see a doctor
if necessary. Do the same if you accidentally get any of the rea-
gent in your eyes.
After completing the QC settings, users can perform the QC analysis in the QC
Analysis interface.

2. Click QC Analysis and enter the QC analysis interface as shown in Figure 45.
98
Figure 45
QC Analysis
3. Select the QC file No. to be run. The screen will display the corresponding
information and QC parameters.
4. Be sure that the level of the control to be run is the same with the current QC
file, and the control to be run is not expired.
5. Prepare the controls according to control instructions. If the QC mode is Pre-
dilute-DIFF, Predilute the controls with reference to chapter 6.4 Sample Coll-
ection and Handling and get diluted QC samples.
! Note:
-- Be sure to evaluate predilute stability based on your laboratory’s sam-
ple population and sample collection techniques or methods.
6. Mix the prepared control as shown below to mix it well.
Figure 46
Mixing the Controls

7. In the ready for counting state (namely, the indicator light of the main unit
is green), place the controls under the sample probe where the probe can
aspirate the well-mixed controls.
8. Press the aspirate key and start running the controls.
9. Upon the completion of the aspiration, you’ll hear a beep and you can re-
move the controls. When the running of QC analysis is complete, the QC
results will be displayed in the current screen (as shown in Figure 47) and
saved in the QC file automatically.
Figure 47
Analysis Results
10. Perform the above procedures to continue running the controls if necessary.
! Note:
-- If the QC file is outdated, its valid period will be displayed in red.
-- “” or “” alarm symbol will be displayed next to the results with
deviations exceeding the set limits.
100
7.1.3.2 Completing QC Analysis in the Sample Analysis Interface

CAUTION
-- Running quality controls in presence of errors may lead to in-
correct analysis results. If you see the error alarms when run-
ning the quality controls, please stop and resume the analysis
until the errors are removed.
-- Do not re-use such disposable products as collection tubes, test
tubes, capillary tubes, etc.
-- Sample clump may lead to incorrect analysis results. Check if
clump exists before running the controls; if it does, handle it as
per the related laboratory procedures.
! Note:
-- You should only use the HUMAN-specified controls and reagents.
Store and use the controls and reagents as instructed by instructions
for use of the controls and reagents. Using other controls may lead to
incorrect QC results.
-- Before being used for analysis shake well the controls that have been
settled for a while.
-- Be sure to use the HUMAN-specified disposable products including
-- If the blood-sample mode is Predilute, then a reminder of predilute
counting will pop up if the user presses the aspirate key to perform the
counting. To close the prompt, please refer to Auxiliary Settings.
After completing the QC settings, you can place the controls among the daily
samples and perform analysis together in the Sample Analysis interface. After
the analysis is completed, the system will store the results to the QC file with
the corresponding ID.
Specific steps for performing QC analysis in the Sample Analysis interface are
as follows:
1. Prepare the controls according to the set control mode and control instruc-
tions.
2. In pre-dilution mode: Predilute the controls with reference to chapter 3.1.13
Sample Collection and Handling and get diluted QC samples if the QC mode
is Predilute.

3. Enter the set QC Sample ID in the Sample ID edit box (other options can be
ignored). Refer to chapter 7.1.2.1 Entering QC Information for the setting of
the QC Sample ID.
4. Well mix the prepared controls.
5. In the ready for counting state of the analyzer (namely, the indicator light of
the main unit is green), place the controls under the sample probe where the
probe can aspirate the well-mixed controls.
6. Press the aspirate key and start running the controls.
7. Upon the completion of the aspiration, you’ll hear a beep and you can re-
move the controls. When the running of the controls is complete, the QC
results will be saved in the QC file automatically.
8. Perform the above procedures to continue running the controls if necessary.
-- If the QC file is outdated, its valid period will be displayed in red.

-- “” or “” alarm symbol will be displayed next to the results with devia-
tions exceeding the set limits.
! Note:
-- It is not recommended to exceed the limits higher than shown on the
target value sheet of the control.
-- Be sure to evaluate predilute stability based on your laboratory’s sam-
ple population and sample collection techniques or methods.
Figure 48
102
7.1.4 QC RESULT REVIEW

After running controls, you can review the QC results in the following two forms:
-- QC Graph
-- QC Table
7.1.4.1 Levy-Jennings Diagram

You can review the result of L-J QC graph as per the following
steps.

2. Click QC Graph to enter the interface as shown in Figure 49.
Figure 49
Graph Interface
3. Select the QC file No. you want to review. The screen will display the corre-
sponding information and the graph. See Figure 50.

Figure 50
QC Graph
4. Click the buttons at the right side of the QC graph, then you can browse QC
graphs of different parameters; click the buttons at the bottom of the QC
graph, then you can browse all QC results.
Introduction to the Levy-Jennings Interface
Figure 51
3 2 1
4 7 6
8
104
Interface Description:
1. The Mean, SD and CV% of all the QC results of each parameter in the current
graph.
2. The saving date and time of the QC points located on the grey line.
3. The operator who run the QC analysis and obtained the QC points located
on the grey line.
4. The QC results of the parameters that correspond to the QC points located
on the grey line.
5. The QC points in each graph are displayed from left to right according to the
sequence from the earliest to the latest. The QC points are connected by a
line to illustrate the distribution trend.
6. The QC point corresponds to each QC result. Only the selected QC point dis-
plays its value under the parameter. The black QC point indicates the value is
within the limit; the red QC point indicates the value is out of the limit.
7. When you clicking a QC point in the graph, the QC points of other parame-
ters saved together with this one will be marked by a grey line.
8. The relative position of the QC point located on the grey line and the total QC
points saved currently.
! Note:
-- The outliers are excluded from the calculation of Mean, SD and CV%.
-- See below how to define a value as outlier.
Delete
The administrator can delete the QC results by the following steps:
-- Delete a single QC result
• Move the grey line to the desired QC result, and click Delete.
• Select Current Data in the pop-up dialogue box as shown in Figure 52.
Figure 52
Deleting Current QC Data
(QC Graph)
• Click OK.

-- Deleting all the QC results in the current QC file. Click Delete, select All Data
in the pop-up dialogue box, then click OK. See Figure 53.
Figure 53
Deleting all QC Data (QC Graph)
Entering the Reasons for the Outliers

Do as follows to enter the reasons for the outliers:
1. Move the grey line to the desired QC point, and then click Outliers. The pop-
up window displays the QC results, reference values and target value range
of all parameters corresponding to the grey line as shown in Figure 54. The
QC results exceeding the limit will be displayed in red.
Figure 54
2. You can select the reason from the given ones or manually enter the reasons
(up to 200 characters) into the textbox after selecting Others.
3. Click OK to save the reasons for the outliers and exit.
! Note:
If you enter the reason for the group of QC points whose results are ac-
tually within the limits, then their corresponding QC data both in the QC
Graph and QC Table will be displayed in red. And the data will return in
black if you cancel the reason and then save the changes.
106
Print
You can have the QC data of the current page or all QC data in the QC file printed
by clicking the Print button.
7.1.4.2 Table
All the samples, controls, calibrators, reagents, wastes and areas in contact with
them are potentially biohazardous. Wear proper personal protective equipment
(e.g. gloves, lab uniforms, etc.) and follow laboratory safety procedures when
handling them and the relevant areas in the laboratory.

2. Click QC Table to access the interface as shown in Figure 55.
Figure 55
3. Select the QC file No. you want to review. The screen will display the corre-
sponding information and the table.
4. Click the buttons at the bottom of the table to browse the QC data of de-
sired parameters; click the buttons on the right of the table to browse the
QC results.

Editing
Choose a row in the QC table and click Edit, then you can edit the selected QC
data. The edited data will be marked with an E. See Figure 56.
Figure 56
Editing QC Results
Restoring
Click Restore to cancel the editing of the QC results. After the data is restored,
the E mark will disappear.
Delete
With the administrator-level access, users can delete the selected QC data, QC
data on the current page and all QC data.
-- Delete a selected QC result
• Click the column containing the desired QC result, and then click Delete.
Figure 57
(QC Graph)
• Click OK.
108
-- Delete QC data on the current page

• Click Delete on the page which contains the QC results expected to be
deleted.
• Select Current Page Data in the pop-up dialogue box as shown in Figure
58.
Figure 58
• Click OK.
-- Delete all QC results
! Note:
Please be careful to perform this operation as it will delete all QC data of
the selected QC file and cannot be reverted.
-- Click Delete.
-- Select All Data in the pop-up dialogue box.
-- Click OK.
Figure 59
-- Click Yes to delete all the QC results in the current QC file.

Print
You can print all the QC data or the data within the specified date range of the
selected QC file.
1. Select a QC file No. to be printed.
2. Click Print.
Figure 60
3. Select the QC data to be printed: all data or specified data.

• When All Date is selected, all the QC data of the table will be printed.
• When Specified Data is selected, and the date range is set in the date
controls, the QC data within the specified date range will be printed.
4. Click OK to print the data.
110
Export
If you wish to export the information and the result of the current QC file, do as
follows:
1. Insert a USB flash disk in the USB interface on the analyzer.

2. Click Export.
3. A dialogue box will pop up as shown below:
Figure 61
4. Select an export path for the data and enter the file name. The file will be ex-
ported to the root directory of the USB flash disk (/udisk/sda1) and named in
the format of SampleInfo_yyyyMMdd_hhmmss.csv. Among which, yyyyM-
Mdd_hhmmss means data export year, month, date, hour, minute, and sec-
ond.

5. Click Save. When the export is finished, a message box as shown below will
pop up.
Figure 62
6. Click OK to close the message box.
7.2 X-B Quality Control
7.2.1 QC Principle
The X-B analysis is a weighted moving average analysis that uses values ob-
tained from patient samples. It uses the 3 red cell indices, MCV, MCH and MCHC
to indicate the hematology instrument performance.
This is a QC method without controls, and reflects only an indicator for a correct
analyzer performance. HUMAN highly recommends to use control materials.
Both methods reflect the analysis performance of the analyzer from different
perspective. Thus, one method should not be replaced with the other. It is rec-
ommended the X-B analysis be activated when the sample volume of your labo-
ratory is greater then 100 samples per day.
Effective use of X-B requires randomization of samples and a normal cross sec-
tion of patients to prevent skewing of indices. A reference range is established
by the given reference values as well as lower and upper limits for the purpose
of observing the variation of QC results within the reference range. The analyzer
performs X-B QC for three parameters, MCV, MCH, and MCHC.
Twenty to two hundred samples can be grouped together for X-B numerical
analysis. The samples are derived from the results of normal analyzer counting,
with no distinction of whole-blood or predilute mode. The analyzer can save
maximum 500 X-B QC results. When the saved QC results have reached the
maximum number, the newest result will overwrite the oldest.
112
7.2.2 QC SETTINGS
! Note:
-- Only users with administrator-level access can edit the X-B settings.
-- Perform the QC Settings before running the controls. You can com-
plete the QC settings by entering the QC information.
7.2.2.1 Entering QC Information

You can complete the X-B QC settings as per the following steps:
2. Select X-B from the dropdown list of the QC Type.
3. Click QC Settings. You’ll enter the QC Settings interface as shown in Figure
63.
Figure 63
4. In the Samples/Group edit box, enter the amount of samples to be included

in calculating for an X-B QC point. The range is between 20 and 200 and the
recommended value is 20.

! Note:
Once the Samples/Group is changed, the number of valid sample results
will be recalculated. For example, if 20 valid samples are needed for the
X-B QC calculation, when you change the value of Samples/Group after
10 group of valid sample results have been acquired, these 10 group of
results will be discarded, and only valid sample results generated after-
wards will be used in the QC calculation.
5. Click the Open button of X-B to open the X-B quality control. The samples
results will be included to calculate the X-B.
6. Enter the targets and limits for the QC parameters.
! Note:
-- All the targets and limits for the QC parameters must be entered.
-- When first use, the default setting will provide the Initial values for
the targets and limits of the three QC parameters.
-- If the QC data have existed in the QC file, you are not allowed to edit
the target and limits.
-- You can set the display form of the limits or the calculation method of
the limits among the preset values see chapter 7.2.2.2
7. Set the valid upper and lower limits for the QC parameter in Sample Validity
Setting field. Setting sample validity is to set the valid range of four QC pa-
rameters, RBC, MCV, MCH and MCHC. To be incorporated into X-B QC calcu-
lation, the sample results should satisfy the validity ranges of all these four
parameters.
! Note:
Once the Samples/Group is changed, the number of valid sample results
will be recalculated. For example, if 20 valid samples are needed for the
X-B QC calculation, when you change the value of Samples/Group after
10 group of valid sample results have been acquired, these 10 group of
results will be discarded, and only valid sample results generated after-
wards will be used in the QC calculation.
8. Click the Save button to save all the settings of the QC. If the entered value
exceeds the acceptable range or the upper limit is lower than the lower limit,
a reminder message will pop up and you will be prompted to re-enter the
correct data and save the entry again.
114
7.2.2.2 Setting Limits

You can take the following steps to adjust the display format of the limits and
the calculation method of the preset limits.
1. Click Set Limits. The interface pops up a dialogue box as shown below.
Figure 64
2. Select By SD or By CV according to the actual needs.

-- If By SD is selected, the limits will be displayed in form of absolute value.
Click 2SD or 3SD to select either double or triple standard deviation to be the
limits.
-- If By CV is selected, the limits will be displayed in form of percentage. Click
2CV or 3CV to select either double or triple coefficient of variation to be the
limits.
3. Click OK to save all the settings for the limits.
7.2.2.3 Restoring Defaults

In QC setting, click Restores Defaults button to restore the parameter reference
values, limits and sample validity to the default settings.
! Note:
-- If QC data are existing in the QC file, you are not allowed to restore the
parameters.
-- Clicking Restores Defaults can only store the default settings of
Target, Limits and Sample Validity Setting, while Samples/Group, X-B
QC switch and limit settings cannot be restored.

7.2.3 QUALITY CONTROL ANALYSIS

After the QC settings, the analyzer will automatically start the X-B QC analysis.
After every 20~200 results (determined by the setting) are obtained, the system
will perform the X-B calculation once automatically. You can review the result
in X-B graph or X-B table. In X-B QC, sample results conforming to any of the
following conditions will be considered as invalid and cannot be used in the QC
calculation.
-- Sample results exceeding the linearity range
-- Background results
-- Sample results not conforming to the Sample Validity Setting
-- QC data for other QC programs (such as L-J QC)
-- Calibration data
-- Results generated while there are errors which could affect the accuracy of
the results (insufficient aspiration volume or clogging for example).
7.2.4 QC RESULT REVIEW

After running controls, you can review the QC results in the following two forms:
-- QC Graph
-- QC Table
7.2.4.1 Graph
Access the X-B QC Graph interface by taking the following steps:
3. Click Graph. The X-B QC Graph interface will be displayed, see Figure 65.
116
Figure 65
QC Graph
4. You can also drag the scroll bar down to the graph horizontally to browse all
the QC results.
Introduction to the Graph Interface
Figure 66
4
2

1. The amount of samples included in calculating for each QC point.

2. The Mean, SD and CV% of all the QC results of each parameter in the current
graph.
3. The QC results of the parameters that correspond to the QC points located
on the green line.
4. The QC points in each graph are displayed from left to right according to the
sequence from the earliest to the latest. The QC points are connected by a
line to illustrate the distribution trend.
5. The QC point corresponds to each QC result. Only the selected QC point dis-
plays its value under the parameter. The black QC point indicates the value is
within the limit; the red QC point indicates the value is out of the limit.
6. When you clicking a QC point in the graph, the QC points of other parame-
ters saved together with this one will be marked by a green line.
7. The relative position of the QC point located on the green line and the total
QC points saved currently.
Delete
The administrator can delete the QC results by the following steps:
-- Delete a single QC result
• Move the green line to the desired QC result, and click Delete.
Figure 67
(QC Graph)
• Click OK.
118
-- Deleting all the QC results in the current QC file. Click Delete, select All Data
in the pop-up dialogue box, then click OK. See Figure 68.
Figure 68
Deleting all QC Data
(QC Graph)
Print
Click the Print button to print the QC graph.
7.2.4.2 Table
Access the X-B QC Table interface by taking the following steps:
3. Click QC Table. The X-B QC table interface will be displayed. See Figure 69.
Figure 69
QC Table

Introduction to the QC Table Interface

1 2
Figure 70
3 5 4
1. The amount of samples included in calculating for each QC point.

2. QC parameters (displayed in the same order as the QC Graph screen).
3. The No. of the QC result saved in the QC file (arranged from left to right in the
order that from the earliest to the latest).
4. QC Result. The value of the QC result is the X-B result of each group of sam-
ples.
5. QC flag: A  or a  next to the values are used to prompt the results that
are out of the limits.
Delete
With the administrator-level access, users can delete the selected QC data, QC
data on the current page and all QC data.
-- Delete a selected QC result
• Click the column containing the desired QC result, and then click Delete.
Figure 71
(QC Graph)
• Click OK.
120
-- Delete QC data on the current page.

• Click Delete on the page which contains the QC results expected to be
deleted.
• Select Current Page Data in the pop-up dialogue box as shown in
Figure 72.
Figure 72
• Click OK.
-- Delete all QC results.
! Note:
-- Please be careful to perform this operation as it will delete all QC data
of the selected QC file and cannot be reverted.
• Click Delete.
• Select All Data in the pop-up dialogue box.
• Click OK. The interface pops up a dialogue box as shown below.
• Click Yes to delete all the QC results in the current QC file.
Figure 73
Print
You can print all the QC data or the data within the specified date range of the
selected QC file. Detailed steps are shown below:
1. Select a QC file No. to be printed.
1. Click Print.

Figure 74
2. Select the QC data to be printed: all data or specified data.

• When All Date is selected, all the QC data of the table will be printed.
• When Specified Data is selected, and the date range is set in the date
controls, the QC data
• Within the specified date range will be printed.
3. Click OK to print the data.
Export
If you wish to export the information and the result of the current QC file, do as
follows:
2. Click Export.
3. A dialogue box will pop up as shown below.
Figure 75
122
4. Select an export path for the data and enter the file name. The file will be ex-
ported to the root directory of the USB flash disk (/udisk/sda1) and named in
the format of SampleInfo_yyyyMMdd_hhmmss.csv. Among which, yyyyM-
Mdd_hhmmss means data export year, month, date, hour, minute, and
second.
5. Click Save. When the export is finished, a message box as shown below will
pop up.
Figure 76
Export successfully
7.3 Setup
7.3.1 INTRODUCTION
This chapter introduces the daily operations from the startup to the shutdown
of the analyzer.
A flow chart indicating the common daily operation process is presented in
chapter 6 daily operations.
The analyzer has been initialized before delivery. The interfaces upon the initial
startup of the analyzer are system settings by default. Some parameters of the
analyzer can be reset to meet various demands in practical applications. The
analyzer divides the operators into two access levels, common user and admin-
istrator. Note that an administrator can access all the functions accessible to a
common user. This chapter introduces how to customize your analyzer as an
administrator.

7.3.2 INTERFACE INTRODUCTION

After logging in the system (see chapter 6.2 Startup), click Setup to access the
Setup interface. Figure 77 will pop up.
Figure 77
Setup
The administrator is allowed to set the following functions in the Setup inter-
face:
-- System settings
-- Parameter settings
-- Meterage settings
-- LIS communication
-- User management
-- Print settings
-- Auxiliary settings
124
7.3.3 SYSTEM SETTINGS
7.3.3.1 Date and Time

You can set the current date and time, as well as the date display format in the
analyzer system. Specific steps are shown below:
1. Click Date and Time in the System area. The date and time format setting
interface pops up.
Figure 78
2. Click the Date and Time dropdown list and set the current date and time of
the system in the popup dialogue box.
Figure 79
Related descriptions:
-- The input sequence of the controls is the same with the date format on
the top right corner of the dialogue box. For example, if the data format is
yyyy/MM/dd HH:mm:ss, you should input the data in the sequence of year,
month, date, hour, minute, and second.
-- Click or to select a date and time or enter the information in the
textbox directly.
-- Click Cancel to close the window and keep the current date and time set-
tings.

3. Click OK to save and close the message box.

4. Select the format setting from the dropdown list of the Date Format. See
Figure 80.
Figure 80
5. Click Apply. The system message will pop up, indicating the successful set-
ting. See Figure 81.
Figure 81
Successful Setting
of the Date Format
The date and time at the bottom right corner will be displayed in the newly set
format as shown in
Figure 82
Click OK to close the message box.

Click OK to exit.
126
7.3.3.2 Input Settings

Click Input Setting in the System area, and then you can set the soft keyboard
for screen input.
Figure 83
As shown in Figure 83, You can set to turn the soft keyboard on or off.
-- Soft Keyboard
• On (default)
You can enter content using the soft keyboard popped up on the screen.
Functions and applications for the keys are shown in Figure 84.
6
Figure 84
1 Toggling between upper
and lower case
2 Toggling between number
and symbol input
1
3 Hiding the soft keyboard
4 Hiding the soft keyboard
5 Line feed/Enter key
6 Delete key 2 3 4 5
• Off
You need to use an externally connected USB keyboard for entering con-
tent.
7.3.3.3 Lab Information

Click Lab Information in the System selection, then you can set the lab informa-
tion. See Figure 85.

Figure 85
Setting Lab Information
! Note:
Only the administrator has the access for setting the lab information.
General users are only allowed to browse such information. Refer to the
table below for the detailed instructions of parameter setting
Parameter Setting Description Table 15

Hospital Name Enter the name of the hospital where the lab is located. Setting Lab Information
Lab Name Enter the lab name.
Responsible Person Enter the responsible person of the lab.
Contact Information Enter the contact information (telephone number or
E-Mail) of the lab.
Contact in Service Enter the name of the contact person in Service De-
Department partment.
Contact Information Enter the contact information of the contact person in
of Service Department the Service Department.
Analyzer SN Display the serial number of the analyzer. Read only.
Installation Date Display the installation date of the analyzer. Read
only.
Remarks Enter the remarks regarding the lab.
128
7.3.3.4 Auto Maintenance

Click Auto Maintenance in the System selection to access the Auto Maintenance
setting interface. The system auto sleep waiting time and cleanser maintenance
time can be set in the Auto Maintenance interface.
Figure 86
Auto Maintenance
Auto Sleep
In the Wait textbox, the administrators can set the waiting time for enter-
ing the sleep state after the main unit is halted. The range is between 15 and
120 minutes and the default value is 60 minutes.
Auto Cleanser Soak

The administrator is allowed to set the start time of the cleanser soak in the
Start Time textbox. The acceptable value ranges from 0:00 to 23:59 and the
default value is 17:00.
7.3.4 PARAMETER SETTINGS
7.3.4.1 Data Dictionary

You can set shortcut codes for the relevant items of the patient information. If
a shortcut code is set, the shortcut code corresponding to the above mentioned
item can be entered directly when the information is input or numbered, then
the complete information can be displayed without entering (or selecting) com-
plete information. It is a shortcut operation.
Different items can share one shortcut code.

7.3.4.2 Accessing the interface

Click Data in the Para. selection to access the data dictionary setting interface.
See Figure 87. You can set the shortcut code for the relevant items of the patient
information in this interface.
Figure 87
Shortcut Code
You can set the shortcut code for the following items: Department, Submitter,
Patient Type, Gender, Area, Bed No. and Sample Type.
7.3.4.3 Adding a New Item

This section takes the adding of a new department as an example to introduce
the method for adding a new item and its shortcut code. The method for add-
ing other new items is similar and is not introduced in details herein. Steps for
adding a new department are shown as follows:
1. Click New in the Department interface. A dialogue box will pop up as shown
in Figure 88.
Figure 88
Adding a New Item
130
2. Enter a new department name, shortcut code and remarks.

• Newly added department name must be entered and it can not be the
same as existing ones.
• The shortcut code is not necessary to be entered, but once set, every code
must be unique.
3. Click OK to save the information about the new department. Information
about the newly added department will be displayed in the department in-
terface. See Figure 89.
Figure 89
Information of the
Newly Added Department
7.3.4.4 Editing Items/Shortcut Code

This section takes the editing of a department as an example to introduce the
method for editing items and its shortcut code. The method for editing other
new items is similar and is not introduced in details herein.
Steps for editing a department are shown as follows:
1. Select the department to be modified in the Department interface (for ex-
ample the Internal Medicine), then click Edit. A dialogue box will pop up as
shown in Figure 90.
Figure 90
Editing Item/Shortcut Code

2. Modify the Name, Shortcut Code and Remarks in each textbox according to
the actual demand.
• Newly added department name must be entered and it can not be the
same as existing ones.
• The shortcut code is not necessary to be entered, but once set, every code
must be unique.
3. Click OK to save the information.
7.3.4.5 Deleting a Shortcut Code

This section takes the deleting of a department as an example to introduce the
method for deleting items and its shortcut code. The method for deleting other
new items is similar and is not introduced in details herein.
Steps for deleting a department are shown as follows:
1. Select the department to be deleted in the Department interface, and then
click Delete. The interface pops up a dialogue box as shown below:
Figure 91
Deleting a Department
2. Click Yes to delete the department.
7.3.4.6 Parameter Unit

Some of the parameters of the analyzer can use different units which can be
chosen as per user demand.
132
7.3.4.7 Accessing the Interface

Click Parameter Unit in the Para. selection to access the Parameter Unit setting
interface. See Figure 92.
Figure 92
Shortcut Code
7.3.4.8 Selecting Unit System

Click the Select unit system dropdown list and select a unit system for the pa-
rameters among the 7 unit systems (Custom, China, International, Britain, Can-
ada, USA and Netherlands). The default unit system is USA.
-- When selecting different unit standards, the corresponding unit list and unit
option will be displayed differently.
-- If another option is selected except the Custom, then the unit of each param-
eter can only be browsed.
7.3.4.9 Customizing Parameter Unit

1. Select Custom from the dropdown list of Select unit system.
Figure 93

2. Click the parameter, of which the unit is to be set, from the parameter list
(such as WBC).
3. Select a new parameter unit from the Unit Options list.
Figure 94
4. Click Apply or OK to save the configuration.

-- For parameters in the same group, if the unit of any parameter changes, the
units of the other parameters change accordingly. (In the list, parameters
will be sorted by group; the first parameter will be displayed in black and the
other parameters in the same group will be displayed in grey.)
-- If the parameters units change, the display format of the list data will change
accordingly.
7.3.4.10 Retrieving Defaults

When setting the Custom unit system, if you click Default, the unit of the pa-
rameters can be restored to the initial default values.
7.3.4.11 Ref. Range

The reference range based on various normal groups can be set for the analyz-
er in the actual practice. If the analysis result of a sample is beyond the refer-
ence range, it will be regarded as clinically abnormal. The Ref. Range interface is
where you view and set the high and low limits for your patients. The analyzer
flags any parameter value above () or below () these limits. This analyzer
divides the patients into 5 demographic groups: General, Man, Woman, Child
and Neonate. You can also customize other groups. The built in limits are for
reference only. To avoid misleading parameter flags, be sure to set the patient
limits according to the characteristics of local population.
134

Click Ref. Group in the Para. selection to access the reference group settings
Figure 95
Ref. Range
7.3.4.13 Copying a Ref. Group

Select a reference group and click Copy, and a new reference group with
everything the same except the name of the reference group will be added to
the system and a screen as shown in Figure 96 will pop up.
Figure 96
Copying a Ref. Group
You can edit the new reference group. Save and close the screen, and then the
copied reference group will be shown in the reference group list.

Figure 97
Copying a Ref. Group
! Note: The reference group name entered is not allowed to be empty nor
the same as the existing ones.
7.3.4.14 Adding a New Ref. Group

If the built-in reference groups cannot meet the actual demand, you can add
new ones and manually enter the information such as reference ranges for each
parameter, names and genders. The procedures are shown as below:
1. Click New, and a screen for adding a new reference group will pop up. See
Figure 98
Figure 98
Adding a New Ref. Group
2. Complete the entries for each parameter with reference to the parameter
description in Table 16.
136
Parameter Meanings Operation

Ref. Group Name of the new refer- Click the edit box and enter the
Table 16
ence group. information using the soft key-
Description of Ref. Group
board. English characters and num-
parameters
bers are allowed to be entered,
while special characters are not.
! Note:
The reference group name en-
tered is not allowed to be empty
nor the same as the existing ones.
Lower Limit of Lower limit of age of the Enter an integer value in the text-
Age reference group. box and select the age unit (year,
month, week, day, or hour) from
the drop list on the right.
! Note:
The Lower Limit of Age must
be smaller than the Upper Limit
of Age.
Upper Limit of Upper limit of age of Enter an integer value in the text-
Age the reference group. box and select the age unit (year,
month, week, day, or hour) from
the drop list on the right.
! Note:
The Lower Limit of Age must
be smaller than the Upper Limit
of Age.
Gender Gender of the reference Select Man, Woman, Not defined
group. from the dropdown list. The de-
fault setting is empty.
Lower Limit (of Lower limit of param- Click the Lower Limit cell which
parameter) eters of the reference corresponds to the parameter and
group. If the test result enter a new value.
is lower than this value,
it would be regarded as
clinically abnormal. ! Note:
The Lower Limit must be small-
er than the Upper Limit.
Upper Limit Upper limit of param- Click the Lower Limit cell which
(of parameter) eters of the reference corresponds to the parameter and
group If the test result enter a new value.
is higher than this value,
it would be regarded as
clinically abnormal.
! Note:
The Lower Limit must be small-
er than the Upper Limit.

3. Click Save to save the settings.

4. Click Close to exit the interface.
7.3.4.15 Editing a Ref. Group

You can modify the reference range of the parameters according to actual needs
and set suitable reference intervals (age range, gender, etc.). The procedures are
shown as below:
1. Select the reference group to be set, and click Edit to enter the interface as
shown in Figure 99.
Figure 99
Adding a New Ref. Group
2. Refer to Table 16 for the description of the parameters to finish the editing.
! Note:
-- For the built-in reference group, you can modify the upper limit and
lower limit of the parameters, but not its name, the upper limit and
lower limit of age as well as gender.
-- Click Set as default to restore the setting of the selected reference
group to the default value.
-- Non-built-in reference group (which is added by user) cannot restore
defaults.
3. Click Save to save the modification.

4. Click Close to exit.
138
7.3.4.16 Deleting a Ref. Group

Click Delete, and select Yes in the pop-up dialogue box to delete the selected
customized reference group.
Built-in reference group can not be deleted.
7.3.4.17 Setting Default Ref. Group

When you pre-enter patient information in the Sample Analysis interface, the
Ref. Group displayed by default is the default reference group. The default set-
ting is General. You can change it as required. Select a reference group and click
Set as default to set the selected reference group as the default reference group.
As shown in Figure 100, the reference group with a check mark in its Default
column is a default reference group.
Figure 100
Setting Default Ref. Group
7.3.4.18 Automatically Match the Customized Reference Group According to

Age and Gender
If Automatically match the customized reference group according to age and
gender is checked, the customized reference group will be automatically as-
signed patients by the system according to their age and gender when the pa-
tient information is entered. If it fails to find a matching customized reference
group for a patient, the patient will be assigned to the built-in reference group.
When the system automatically matches the reference group according to age
and gender, the rules listed in Table 17 shall be followed.

Automatically match the Customized Ref. Match the reference group Table 17
customized reference group Group
Rules for Matching the Reference
according to age and gender
Group
Unchecked N/A Built-in reference group
Checked None Built-in reference group
Checked Created Preferentially match the
customized reference group
! Note:
When the customized ref. groups are used to match the reference group,
the matching will be performed from top down according to the custom-
ized ref. groups displayed in the screen.
7.3.4.19 Microscopic Exam. Settings

You can perform the microscopic exam. settings, including adding, editing, de-
leting and adjusting the list order as per the actual demand.
! Note:
The operations of adding, editing, deleting and adjusting the list order do
not affect the sample record in which the microscopic examination re-
sults have been entered and saved. Such operations are only valid for the
record in which the microscopic examination results have not been saved,
and the samples analyzed after the setting operations.

Click Microscopic Exam. in the Para. selection to access the microscopic exami-
nation setting interface. See Figure 101.
Figure 101
Microscopic Exam. Settings
140
7.3.4.21 Adding a New Microscopic Exam. Parameter

Do as follows to add a new microscopic examination parameter.
1. Click New in the Microscopic Exam. Settings interface. A dialogue box will
pop up as shown in Figure 102.
Figure 102
Exam. Parameter
2. Input the parameter name and its coding system in the corresponding text-
boxes.
• The Parameter Name can not be empty and up to 32 characters can be
entered.
• The Code System is the code ID of the parameter. It is used for LIS trans-
mission only when the parameter is transmitted to the LIS. You may not
input the value if it is not needed. Up to20 characters can be entered.
3. Click OK. The name of the new parameter will be displayed in the microscop-
ic exam. parameter list.
7.3.4.22 Editing a Microscopic Exam. Parameter

Select a parameter name from the list and click Edit to modify it. See Figure 103.
Figure 103
Editing a Microscopic Exam.
Parameter

7.3.4.23 Deleting a Microscopic Exam. Parameter

Select a parameter name from the list, click the Delete button and then click Yes
in the pop-up dialogue box to delete this parameter.
Figure 104
Deleting a Microscopic Exam.
Parameter
7.3.4.24 Research Use Only (RUO) Parameters

Click RUO Parameters in the Setup > Parameter interface to enter the RUO
Parameters setting interface. See Figure 105.
Figure 105
Setting RUO Parameters
142
! Note:
-- Display RUO Parameters
It’s checked by default, which means the information regarding the
RUO parameters will be displayed in the counting results. If it’s un-
checked, the RUO parameters, the * mark and the declaration will not
be displayed in the counting results.
• Display “*” mark
It’s checked by default, which means the “*” mark will be dis-
played in the counting results; If it’s unchecked, the “*” mark and
the declaration will not be displayed.
• Display declaration
It’s checked by default, which means the declaration will be dis-
played in the counting results; if it’s unchecked, the declaration
will not be displayed.
-- Print RUO parameters
It’s checked by default, which means the RUO parameters will be
printed in the report. If it’s unchecked, the RUO parameters, the “*”
mark and the declaration will not be printed in the report.
• Print “*” mark
It’s checked by default, which means the “*” mark will be printed
in the report. If it’s unchecked, the “*” mark and the declaration
will not be printed in the report.
• Print declaration
It’s checked by default, which means the declaration will be
printed in the report. If it’s unchecked, the declaration will not be
printed in the report.
-- Editing Declaration
The default declaration is: “*” means “research use only, not for
diagnostic use”. You can modify the declaration in the textbox as per
the actual demand. Up to 50 characters can be entered, including all
characters, numbers, letters and other special characters (except “/”
and “\”) on the keyboard.
! Note:
Any change made to the display settings or printing of the RUO param-
eters, the “*” mark and the declaration will be applied to all the RUO pa-
rameters (before and after the change).

7.3.4.25 Customized Parameters

Except for this analyzer’s analysis parameters, parameters collected from other
testing instruments or via manual testing by the user are customized parame-
ters. You can set customized parameters so they can be printed together with
this analyzer’s analysis parameter details on the Hematology Analysis Report.
This analyzer’s default customized parameters include: Blood Type, RH Blood

Group, ESR, C-reactive Protein and Reticulocyte. You can set the unit and refer-
ence range of default customized parameters as well as add and set customized
parameters.

Click Custom Para. in the Para. selection. The customized parameters setting
interface as shown in Figure 106 will pop up on the screen.
Figure 106
Customized Parameter Settings
7.3.4.27 Adding a Customized Parameter

1. Click New. The interface as shown in Figure 107 will pop up on the screen.
144
Figure 107
Adding a Customized Parameter
2. Click the textboxes of Parameter Name and Unit respectively, and enter the
name and unit of the customized parameter.
3. Click corresponding cells of the Upper Limit and Lower Limit of the reference
group, and input values. You can also customize the reference group accord-
ing to the actual situation. For details, see chapter 7.3.4.11 Ref. Range.
4. Click OK. The added parameter will be displayed in the customized param-
eter list.
7.3.4.28 Editing a Customized Parameter

You can set the unit and reference range of customized parameters. Detailed
steps are shown below:
1. Select the customized parameter to be edited, and click Edit. The interface as
shown in Figure 108 will pop up on the screen.
Figure 108
Editing a Customized Parameter

2. Click the textboxes of Parameter Name and Unit respectively, and modify
the name and unit of the customized parameter.
3. Click corresponding cells of the Upper Limit and Lower Limit of the reference
group, and modify the values. You can also customize the reference group
according to the actual situation. For details, see chapter 7.3.4.11 Ref. Range.
4. Click Save.
7.3.4.29 Deleting a Customized Parameter

Select a customized parameter, and click on Delete. Then, the parameter and its
corresponding reference group will be deleted.
7.3.5 USER MANAGEMENT

After logging in the system, the administrator has the access to set the account
information of general users and other administrators; common users can only
browse the user list and change their own passwords.

Click User in the Setup interface to access the user management interface as
shown in Figure 109.
Figure 109
User management
7.3.5.2 Creating a User

Click New to set the account information of a new user in the popup interface,
including username, first and last name, password, user group and remarks, etc.
See Figure 110.
146
Figure 110
! Note:
User Group includes Common User and Administrator. Users are assigned
different access levels according to the user group they belong to. Click
OK after the setting is complete. The information of the new user will be
shown in the user list.
7.3.5.3 Editing a User

Select the user to be edited and click Edit to modify the name and user group.
Figure 111

7.3.5.4 Deleting a User

Select the user to be deleted and click Delete, and then select OK in the pop-up
dialogue box to delete the user.
! Note:
The administrator cannot delete his/her own information.
7.3.5.5 Setting the Default User

Select a user and click Set as default user to set this user as the default user. Af-
ter the setting is completed, the following message box will pop up.
Figure 112
After it is set successfully, the default user name will be displayed in the login
box next time and you only needs to enter the corresponding password. See
Figure 113.
Figure 113
Login after Setting the Default
Use
148
7.3.5.6 Changing Password

Click Change Password, enter the old password and new password of the user
and confirm the new password in the pop-up dialogue box, then click OK.
Figure 114
Changing Password
! Note:
You can only change his/her own password and cannot change the pass-
word of other users.
7.3.5.7 Resetting Password

If the user forgets the password or the password is required to be reset due to
other reasons, please click Reset Password to reset the password of the selected
user to the initial password. The reset password is the same as the user name.
Figure 115 shows that the password is successfully reset.
Figure 115
Resetting Password
! Note:
The administrator is allowed to reset the password of all administrators
and general users; general users do not have the access to reset the pass-
word.

7.3.6 PRINT SETTINGS

Click Print Settings in the Setup interface for relevant print settings, including
the default printer, template, report, copies and margins, etc.
Figure 116
Printer Settings
You can set the printer and driver of the system in the Printer selection. See
Figure 117.
Figure 117
Printer Settings
-- Printer Driver
The system automatically detects the printer driver by default.
-- Printer
Select a printer to be used from the dropdown list. If the dropdown list is
blank, it indicates that no printer has been installed for the operating sys-
tem. In this case, install a printer, and then perform the relevant settings and
printing operations.
-- Printer Resolution
Select a proper resolution from the dropdown list. The higher the resolution
of the printer, the better the print quality.
150
Report Settings
You can set relevant parameters of the report in the Report Settings combo box.
See Figure 118
Figure 118
Report Print Setting
-- Report Title
Enter the title of the report in the Report Title textbox. The default setting is
Hematology Analysis Report.
-- Copies
You can enter the number of copies to be printed for a report in the Copies
textbox according to the actual demand. Click to increase the number of
copies and click to decrease the number of copies or enter the number of
copies in the edit box directly. Range of the copies is between 1 and 100 and
the default value is 1.
Format Settings
Report type and template of prints can be set in the Format Settings combo box.
See Figure 119.
Figure 119
Format Settings

-- Selecting Report Type

Select the format type to be set from the dropdown list of the Report Type.
The default setting is Report.
-- Selecting Paper Type
Select the paper type (size) from the dropdown list of the Paper Type, such
as A4. After the selection is completed, the corresponding paper size will be
shown at the bottom of the list, such as 210*148 mm.
-- Selecting Template
Select the template to be set from the dropdown list of the Template.
-- Refresh
Click Refresh to refresh the format list after the customization by the admin-
istrator. Importing/Exporting template
You can export the existing template to a USB flash disk, and edit the tem-
plate. After editing, import the template to the system to complete the cus-
tomization of the template.
! Note:
Before importing/exporting template, insert a USB flash disk in the USB
interface on the analyzer.
-- Exporting template
Select the template to be exported from the dropdown list of
Template and click Export. Select the export path in the popup dia-
logue box, and click Save.
-- Importing template
Click Import and select the required template in the pop-up dialogue
box, then click Open.
-- Deleting template
Select the template to be deleted from the dropdown list of the
Template.
! Note:
Only customized templates can be deleted, the built-in templates can not
be deleted.
152
Auto Settings
-- Autoprint
The default setting is Off, which means the report should be printed manu-
ally after the results are obtained.
If it is set to On, the system will automatically print the report of the
sample as per the current report template once the counting results are
obtained.
-- If Print after validation is checked, the autoprint function becomes invalid.
-- Auto print is not applicable for the background results.
-- Auto print after validation
It’s unchecked by default, which means the system can print the report au-
tomatically without validation. If it’s checked, the report will be printed au-
tomatically after it’s been validated instead of being printed right after the
results are obtained each time.
The parameter is valid only when the Autoprint is set to On.
-- Auto validate when printing
It’s unchecked by default, which means the report will not be automatically
validated by the system at the time of printing.
If it’s checked, the report will be automatically validated and printed by the
system at the time of printing.
-- Print after validation

It’s unchecked by default, which means the report can be printed without
validation. If it’s checked, the report can be printed only after validation and
autoprint is unexecutable.
Printing Options
-- Print Flag
It’s checked by default, which means the flag information will be printed in
the report. If it’s not checked, it will not be printed.
-- Print Ref. Range
It’s checked by default, which means the reference range of the parameter
will be shown in the printed report; If it’s unchecked, the results alone, rather
than reference range, will be shown in the printed report and the reference
range will not.

-- Print Suspicious Flag

It’s unchecked by default, which means the suspicious flag “?” will not be
shown in the printed report; if it’s checked, such flag can be shown.
-- Print Ref. Range Flags
It’s checked by default, which means the printed report can show the ref.
range flag ( or ); If it’s unchecked, such a flag will not be shown.
-- Print Microscopic Exam. Para.
It’s checked by default, which means the result of Microscopic Exam. Param-
eters will be printed in the report. If it’s not checked, it will not be printed.
-- Print result edited flags
It’s unchecked by default, which means the mark for the edited results will
not be shown in the printed report. If checked, the mark (M or m) for the ed-
ited results will be shown in the printed report if the parameters have been
modified.
-- Two reports in one page (half of A4)
It’s unchecked by default. If this is checked, the default template size in For-
mat Settings is half an A4 page (e.g., A4_Half-Portrait-Parameters), so two
reports can be printed in one piece of A4 paper.
When Auto Increment is selected as the Sample ID entry method, you can add
a prefix to a certain batch or samples for identification. Enter the prefix length
ranging from 0 to 24 (e.g. 2) of the sample ID in the Prefix Length textbox. The
prefix length will be applied to all sample IDs after the setting is saved.
Startup sample ID and mode

Set the sample ID and measurement mode for the next sample after startup.
-- Next sample ID and mode after startup
The sample ID and mode set by the user will be used by the system after the
next startup when the specified sample ID is entered into the textbox and
the measurement mode (CBC or CBC+DIFF) is selected from the dropdown
list. If the Effective tomorrow is checked, the modification of the next sam-
ple ID and mode after startup will become effective on the next day.
-- Continue using the sample ID and mode before the last shutdown
If checked, the system will by default add 1 to the last sample ID analyzed
before shutdown as the next sample ID after startup.
154
Predilute
Set if you wish to see a pop-up dialogue box when you perform the Predilute
counting.
-- Ask for confirmation (default setting): In the Predilute mode, when you press
the aspirate key to start the analysis, a dialogue box will pop up to remind
you that the ongoing analysis is for Predilute counting.
-- Do not ask for confirmation: The dialogue box for confirming the Predilute
counting will not pop up.
Other
-- Show Result Edited Flags
It’s unchecked by default, which means the edited results are marked with
an M at the end, while the corresponding results with manual modifications
are marked with an m at the end. M or m is displayed between the result
data and the parameter unit by default.
If unchecked, the edited result will not be marked with an M or m.
-- Automatically generate the delivery date
It is checked by default, which means you do not need to manually enter the
Delivery Time when you modify patient information after running a sample.
The operating date will be displayed in the date textbox.
! Note:
When Autoprint is On, a page remains to be printed with one report.
-- Update blank test time before be printed
It’s unchecked by default, which means the blank test time will not be
processed by the system.
If it’s checked, the Delivery Time will be automatically updated as the
Run Time by the system at the time of printing.
-- Print as black and white
It’s unchecked by default, which means the report will be printed ac-
cording to the default settings of the printer.
If it’s checked, the report will be printed as black and white.

7.3.7 AUXILIARY SETTINGS

Click Auxiliary Settings in the Setup interface to access the Auxiliary Settings
Figure 120
Auxiliary Settings
The administrator is allowed to set the following functions in the Auxiliary Set-
tings interface:
-- Sample Numbering Rules
-- Startup sample IP and mode
-- Predilute
-- Other
Sample Numbering Rules

Set the sample ID entry rules.
-- Sample ID Entry Method
Click the dropdown list of the Sample ID Entry Method and select the entry
method of the sample ID from the following options.
• Auto increment (default setting)
• Manual entry
156
-- Prefix Length
When Auto Increment is selected as the Sample ID entry method, you can
add a prefix to a certain batch of samples for identification. Enter the prefix
length ranging from 0 to 24 (e.g. 2) of the sample ID in the Prefix Length text-
box. The prefix length will applied to all sample IDs after the setting is saved.
Startup sample IP and mode

Set the sample ID and measurement mode for the next sample after startup.
-- Next Sample ID and mode after startup
The sample ID and mode set by the user will be used by the system after the
next startup when the specified sample ID is entered into the textbox and
the measurement mode (CBC or CBC+DIFF) is selected from the dropdown
list.
! Note:
When Autoprint is On, a page remains to be printed with one report. If
the Effective tomorrow is checked, the modification of the next sample ID
and mode after startup will become effective on the next day.
-- Continue using the sample ID and mode before the last shutdown. If
checked, the system will by default add 1 to the last sample ID analyz-
ed before shutdown as the next sample ID after startup.
Predilute
Set if you wish to see a pop-up dialogue box when you perform the Predilute
counting.
-- Ask for confirmation (default setting): In the Predilute mode, when you press
the aspirate key to start the analysis, a dialogue box will pop up to remind
you that the ongoing analysis is for Predilute counting.
-- Do not ask for confirmation: The dialogue box for confirming the Predilute
counting will not pop up.
Other
-- Show Result Edited Flags
It’s unchecked by default, which means the edited results are marked with
an M at the end, while the corresponding results with manual modifications
are marked with an m at the end. M or m is displayed between the result
data and the parameter unit by default. If unchecked, the edited result will
not be marked with an M or m.

-- Automatically generate the delivery date

It is checked by default, which means you don’t need to manually enter the
Delivery Time when you modify patient information after running a sample.
The operating date will be displayed in the date textbox. If unchecked, the
Delivery Time shall be manually entered when patient information is modi-
fied in Sample Analysis interface.
-- Automatically generate the sampling date
It is checked by default, which means you don’t need to manually enter the
Sampling Time when you modify patient information after running a sam-
ple. The operating date will be displayed in the date textbox. If unchecked,
the Sampling Time shall be manually entered when patient information is
modified in Sample Analysis interface.
-- Suspicious Flag
A single character (an English letter only) can be re-entered in the textbox as
a suspicious flag. The default value is ?.
-- Ref. Range Flags
You can select the Ref. Range Flags from the dropdown list. The default high
flag is  (or H) and the default low flag is  (or L).
7.3.8 CONNECTING THE ANALYZER SYSTEM
7.3.8.1 Electrical Connections

Please refer to Figure 121 for the electrical connections of the analyzer.
Figure 121
Connecting the electrical devices
158
7.3.8.2 Reagent Connections
WARNING
-- Be sure to dispose reagents, waste, samples, consumables, etc.
according to local legislations and regulations.
-- Reagents can be irritating to the eyes, skin, and mucosa. Wear
proper personal protective equipment (e.g. gloves, lab uni-
forms, etc.) and follow laboratory safety procedures when han-
dling them in the laboratory.
-- If the reagent accidentally comes in contact with your skin,
wash it off immediately with plenty of water and see a doctor
if necessary. Do the same if you accidentally get any of the re-
agent in your eyes.
CAUTION
-- Please make sure the length of the diluent pipe and the waste
pipe should be no longer than 1500 mm; the length of the lyse
pipe and the cleanser pipe should be no longer than 850 mm.
-- Tighten the panel connector of the fluidic line so that the over-
all fluidic line is closed to prevent leakage and seepage caused
by siphonage, etc. Refer to Figure 122 for the connection of the
reagents placed outside the analyzer.
Figure 122
Connecting reagents placed
outside the analyzer

Refer to Figure 123 for the connection of the reagent placed inside the analyzer
HumaCount 5D.
Figure 123
Connecting reagents placed
inside the analyzer HumaCount
5D (left door opened)
HC5D HC5D
Diff Lyse CBC Lyse
7.3.8.3 Installing the Diluent Float Sensor and Replacing the Reagents
Please install the diluent float sensor and replace the diluent as per the ap-
proaches stated in this section.
7.3.8.4 Installing the Diluent Float Sensor

Install the diluent float sensor according to the following steps.
1. Press down and remove the round cardboard with dotted cutting line on the
top side of the diluent box so as to reveal a round hole.
2. Pull out the cover of the container so that the cardboard around the round
hole can seize the neck under the vial cap to prevent invagination.
3. Turn and open the cap (keep the cap) and prevent any foreign objects from
getting into the container.
4. Install the diluent float sensor assembly in the accessory pack as shown in
Figure 124. The float sensor shall be kept as vertical as possible during instal-
lation and the self-contained cap of the sensor shall be tightened.
160
Figure 124
Installing the Diluent Float
Sensor
7.3.8.5 Replacing Reagents

Steps for the replacing the diluent are the same as that for installing the sensor.
Please keep the empty diluent container and the cap for future use.
7.3.8.6 Installing the Waste Float Sensor

The float sensors used in the analyzer are only applicable to HUMAN-supplied
waste containers or the containers with the same specification and model (such
as the vacant diluent container).
1. Take a proper waste container (it can be a vacant diluent container, the open-
ing of which is required to be pulled out of the hole of the box to expose the
opening) and open the vial cap.
2. Install the waste float sensor assembly in the accessory pack as shown in
Figure 125. The float sensor shall be kept as vertical as possible during in-
stallation and the self-contained cap of the sensor shall be tightened at the
same time to prevent the spilling of the waste.
Figure 125
Installing the Waste Float Sensor

The waste container can be replaced according to the steps mentioned above.
The replaced waste shall be properly disposed to avoid contamination.
WARNING
7.3.8.7 Connecting the LIS

If the analyzer needs to be connected to laboratory information system (here-
inafter referred to as LIS), you can complete the connection by following the
steps in this section.
7.3.8.8 Installing LIS Workstation

1. Install LIS workstation and set instrument type and model.
2. Enter LIS workstation network setup interface after installation and set
monitoring IP address and port number.
Please contact the Human customer engineer to get Description of LIS Commu-
nication Protocol for Human Hematology Analyzers to complete the support of
the LIS workstation to the LIS communication protocol.
7.3.8.9 Host Communication Settings

1. Use a network cable to connect the analyzer to LIS local area network.
2. Please log on the hematology analyzer software as administrator; if the ana-
lyzer is turned on, skip this step. For details, see 6.2 Startup. The whole pro-
cess lasts for 4 to 12 minutes. Please be patient.
162
3. In the Setup interface, click Host Communication in the Communication se-

lection to access the Laboratory Information System (LIS) communication
setting interface. See Figure 126.
Figure 126
Host Network Settings
4. Set the IP address and other network information of the analyzer according
to the actual situation.
• If the network is accessed through a router on the site, please select Ob-
tain an IP address automatically and Obtain DNS server address auto-
matically.
• If the network is accessed through a network switch, or the analyzer is
directly connected to the LIS on the site, please select Use the follow-
ing address, so as to manually set the IP address and subnet mask of the
analyzer. The IP addresses of the analyzer and LIS must be in the same
network segment. Furthermore, their subnet masks shall be the same,
while other parameters can maintain null. Click OK to save the settings
and close the dialogue box.

7.3.8.10 Connecting Analyzer with LIS

1. Please log on the hematology analyzer software as administrator; if the ana-
lyzer is turned on, skip this step. For details, see 6.2 Startup. The whole pro-
cess lasts for 4 to 12 minutes. Please be patient.
2. In the Setup interface, click LIS Communication in the Communication se-
lection to access the Laboratory Information System (LIS) communication
setting interface. See Figure 127.
Figure 127
Communication Settings
3. Input the IP address and port of LIS workstation in Network Settings area.
Find the IP address and port of LIS in the network setup interface in the LIS
workstation; if IP address can’t be found, try the method below:
• Enter the operating system of LIS workstation.
• Press combination key [Windows+R] to open the Run window.
• Input cmd, and then click OK.
• Input the ipconfig command into the cmd.exe window popped out. The
interface shows similar content as follows:
164
Figure 128
The IPv4 address in the red box is the IP address of LIS workstation.
-- The IP address 192.168.8.44 of the LIS workstation shown as above is used as
an example, real IP should be in the same network segment with LIS server.
4. Click OK to save the settings.
5. Check if the connection is successful.
The LIS icon in the upper right side on the analyzer screen turns from grey to
black , which indicates auto hematology analyzer software is connected to LIS
successfully. If the icon stays grey, the connection fails. Please check if the IP
address and port of LIS is correct and reconnect as the steps above; if the prob-
lem still exists, please contact the hospital network administrator or HUMAN
customer service engineer to handle it.

7.4 Ranges of parameters.
7.4.1 REFERENCE/NORMAL RANGES
Patient Type Table 18

General Man Women Child Newborn
Reference values
Para-me- Lower Upper Lower Upper Lower Upper Lower Upper Lower Upper
Unit implemented
ter limit limit limit limit limit limit limit limit limit limit
in software of
WBC 109/l 4 10 4 10 4 10 4 12 4 20
Neu% % 50 70 50 70 50 70 50 70 40 80 HumaCount 5D
Lym% % 20 40 20 40 20 40 20 60 10 60
Mon% % 3 12 3 12 3 12 3 12 3 13
Eos% % 0,5 5 0,5 5 0,5 5 0,5 5 0,5 5
Bas% % 0 1 0 1 0 1 0 1 0 1
Neu# 109/l 2 7 2 7 2 7 2 8 1,6 16
Lym# 109/l 0,8 4 0,8 4 0,8 4 0,8 7 0,4 12
Mon# 109/l 0,12 1,2 0,12 1,2 0,12 1,2 0,12 1,2 0,12 2,5
Eos# 109/l 0,02 0,5 0,02 0,5 0,02 0,5 0,02 0,8 0,02 0,8
Bas# 109/l 0 0,1 0 0,1 0 0,1 0 0,1 0 0,2
ALY# 109/l 0 0,2 0 0,2 0 0,2 0 0,2 0 0,2
ALY% % 0 2 0 2 0 2 0 2 0 2
LIC# 109/l 0 0,2 0 0,2 0 0,2 0 0,2 0 0,2
LIC% % 0 2,5 0 2,5 0 2,5 0 2,5 0 2,5
RBC 1012/l 3,5 5,5 4 5,5 3,5 5 3,5 5,2 3,5 7
HGB g/l 11 16 120 160 110 150 120 160 170 200
HCT % 37 54 40 54 37 47 35 49 38 68
MCV fl 80 100 80 100 80 100 80 100 95 125
MCH pg 27 34 27 34 27 34 27 34 30 42
MCHC g/l 320 360 320 360 320 360 310 370 300 340
RDW-CV % 11 16 11 16 11 16 11 16 11 16
RDW-SD fl 35 56 35 56 35 56 35 56 35 56
PLT 109/l 100 300 100 300 100 300 100 300 100 300
MPV fl 6,5 12 6,5 12 6,5 12 6,5 12 NA NA
PDW fl 9 17 9 17 9 17 9 17 9 17
PCT ml/l 0,108 0,282 1,08 2,82 1,08 2,82 1,08 2,82 NA NA
P-LCR % 11 45 11 45 11 45 11 45 NA NA
P-LCC 109/l 30 90 30 90 30 90 30 90 NA NA
166
7.4.2 ANALYTICAL MEASUREMENT RANGES
Table 19
Range Display Range Linearity Range
Parameter Low High Low High Unit
Display ranges and Linearity
WBC 0 999 0 300 109/l
ranges of all parameters of Hu-
NEU# 0 999 0 300 109/l
maCount 5D. LYM# 0 999 0 300 109/l
MON# 0 999 0 300 109/l
EOS# 0 999 0 300 109/l
BAS# 0 999 0 300 109/l
ALY# 0 999 0 300 109/l
LIC# 0 999 0 300 109/l
NEU% 0 99.9 NA NA %
LYM% 0 99.9 NA NA %
MON% 0 99.9 NA NA %
EOS% 0 99.9 NA NA %
BAS% 0 99.9 NA NA %
ALY% 0 99.9 NA NA %
LIC% 0 99.9 NA NA %
RBC 0 18 0 8.5 1012/l
HGB 0 300 0 250 g/l
MCHC 0 9999 NA NA g/l
MCH 0 999 NA NA pg
HCT 0 80 0 67 %
MCV 0 250 NA NA fl
RDW-SD 0 999 NA NA fl
RDW-CV 0 99.9 NA NA %
PLT 0 5000 0 3000 109/l
MPV 0 99.9 NA NA fl
PDW 0 999 NA NA NA
PCT 0 0.999 NA NA %
P-LCR 0 99.9 NA NA 109/l
P-LCC 0 5000 NA NA %

Calibration 167
8 CALIBRATION
8.1 Introduction
Calibration is a procedure to standardize the analyzer by determining its devi-
ation, if any, from calibration references and to apply any necessary correction
factors. To get accurate blood analysis results, perform calibration of the analyz-
er following the procedures given in this chapter when it’s needed.
! Note:
-- Calibration procedures can only be performed by users with the ad-
ministrator-level access. The login users with the access level of gen-
eral users can not perform the calibration procedures but only browse
the calibration coefficients.
-- You should only use the Human-specified calibrators and reagents.
Store and use the calibrator and reagents following the instructions
for use of the calibrations and reagents.
-- The analyzer identifies a sample as a calibration sample only if the
analysis is started from the Cal interface.
-- The calculation of repeatability is included in the calibration proce-
dure.
8.2 When to Calibrate

This analyzer is calibrated at the factory just before shipment. It is electronically
stable and does not require frequent recalibration if you operate and maintain it
as instructed by this manual. You need to recalibrate this analyzer if:
-- It is the first time this analyzer has been used (usually done by a Human-au-
thorized representative when installing the analyzer).
-- An analytical component has been changed.
-- The quality control results indicate that there may be a problem.
-- The operating environment (such as the temperature) has changed signifi-
cantly.
! Note:
-- All of the measured parameters must be calibrated before readings of
this analyzer can be used as valid analysis results.
-- For laboratories conducting routine tests, the calibration should be ap-
plied at least once every six months.
168
8.3 How to Calibrate

There are three calibration programs available on this analyzer: manual calibra-
tion, auto calibration using calibrators and auto calibration using fresh blood
samples. All or part of the parameters of WBC, RBC, HGB, MCV and PLT can be
calibrated by the calibration procedure.
1. Check and make sure enough reagents have been prepared for the calibra-
tion. You need to start over the calibration if the reagents run out during the
process.
2. Do the background check. If the analyzer alarms are activated for abnormal
background results, see 11 Troubleshooting for solutions. Run the median
controls in whole blood-CBC+DIFF mode consecutively for 11 times, take and
view repeatability of the counting results from the 2nd run through the 11th
run in the Review interface and make sure they are within the range speci-
fied in A.4.4 Repeatability.
3. Run the corresponding diluent for 3 times immediately after running the
high-level controls for 3 times and calculate the carryover by the following
formulae:
First low-value sample result – Third low-level sample result

Carryover (%) = x100%
Third high-value sample result – Third low-level sample result
The calculated carryovers shall meet the requirements in A.4.5 Carryover.

4. It is recommended that you create a log table for your analyzer. The suggest-
ed items that you may want to include in the log table are: calibration date,
supplier of calibrator, lot number, expected results and limits, and result of
background check.
8.3.1 MANUAL CALIBRATION

Complete the manual calibration as per the following procedure:
1. Click Cal in the menu page to access the calibration interface.
2. Click Manual to access the manual calibration interface. See Figure 129.

Calibration 169
Figure 129
Manual Calibration
The calibration coefficients of whole blood mode and predilute mode are dis-
played on the manual interface.
! Note:
-- The login users with the access level of general users can not perform
the calibration procedures but only browse the calibration coefficients
on the current screen. To perform the calibration, please log out and
then log in as users with administrator-level access.
3. Check the calibration coefficient and calculate the new coefficient using the
following equation.
Current calibration factor x Reference value

New calibration factor =
Mean
For example, the WBC reference value of a calibrator is 8.3, and the current
calibration coefficient of the whole blood mode is 99.00%. Run the calibrator
in whole blood mode for 11 consecutive times and calculate the WBC results of
the 2nd to 11th runs (n=10):The obtained CV is 1.1% and the Mean is 8.22, which
meet the requirements. The new calibration coefficient is obtained:
99.00% x 8.3
New calibration factor = = 99.96%
8.22
The calculated calibration coefficients shall be between 75%~125%. In case
of an invalid calibration coefficient, try to find out the reason (e.g. calibration
material not thoroughly mixed, incorrect operation, etc.).Then recalibrate the
analyzer and recalculate the calibration coefficients.
4. Enter the new calibration coefficients into the factor cell of the parameter
that requires calibration. The entered calibration coefficients shall be be-
tween 75.0%~125.0% (calculation results rounded to two decimal places).
5. Click Save.
-- If the new calibration coefficient is valid and different from the original val-
ue, the following dialogue box will pop up.
170
Figure 130
Calibration set successfully
On the screen, the calibration coefficient is refreshed to be the new one and the
calibration date is refreshed to be the current system date.
-- If the new calibration coefficients are invalid, the message box will pop up.
Click OK to close the message box and enter a valid factor.
Figure 131
Invalid Coefficients
6. (Optional) Click Print to print the current calibration coefficient.

7. Click Exit to close the Manual interface.
8.3.2 AUTO CALIBRATION USING CALIBRATORS
! Note:
-- Only Human-specified calibrators shall be used. Human will not be re-
sponsible for any erroneous result caused by using other calibrators.
-- See the instructions for use of the calibrators for the lot No., Exp. Date
and the target. Complete the calibration with calibrators as per the
following procedure:

2. Click Calibrator.
The Calibrator interface pops up as shown in Figure 132.

Calibration 171
Figure 132
Auto Calibration Using
Calibrators
3. Enter the lot No. of the calibrator into the Lot No. box.
4. Click the Exp. Date box, and then edit the Exp. Date.
! Note:
-- The Exp. Date can be no earlier than the current system date.
-- The entered Exp. Date should be either the Exp. Date printed on the la-
beling or the open-container expiration date, whichever is earlier. The
open-container expiration date is calculated as follows: The date on
which the container is opened + the open-container stability in days.
5. Input the target values of the parameters in the corresponding cell of the
Target.
6. Prepare the calibrators following their instructions for use and place the cal-
ibrators under the sampling probe.
7. Press the aspirate key to start the calibration counting. After every calibra-
tion run, the progress bar will close automatically and the analyzer will have
different responses according to different analysis results.
-- If the results are valid and within the linearity range, they will be displayed
directly.
172
-- If the calibration counting data of any parameter in the current counting is

out of the display range or linearity range of the parameter, a message box
will pop up on the screen prompting that the calibration data is invalid. Click
OK to close the message box and delete the data from the table without
saving.
-- If any of the parameter’s value in the calibration counting differs from the
Target value by more than 50%, the system will prompt you with a message
box asking if the calibration counting results should be kept. To keep the
results, click Yes; to remove the results, click No.
! Note:
-- After the valid calibration result is obtained, the parameters with cor-
responding checkboxes ticked off will be involved in the calculation of
the calibration coefficients by default.
-- If you switch to other interfaces before the new calibration coefficients
are obtained, the system will discard the current calibration data and
keep the original calibration coefficients.
8. To get 10 valid counting results, repeat steps 6~7 ten times. The analyzer will,
by default, calculate the Mean, CV% and the new calibration coefficients
based on all the ticked-off calibration data according to the formulae.
9. You can select a few groups of data for the calculation of the calibration co-
efficients which can be obtained unless at least 5 groups of ticked-off data
are included. Each time when you tick off or uncheck the checkboxes, the
calibration coefficients will be refreshed and displayed in time. When the
amount of the valid calibration data in the list reaches 10, a message box of
Calibrator calibration done! will pop up. Click OK to close the message box.

Calibration 173
! Note:
The out-of-range CV% does not influence the display of the calibration
coefficients.
10. Click Save.

-- If the calculated calibration coefficients of all parameter are within the range
of 75%~125% and the CV% of all parameter are also within the repeatability,
then a dialogue box prompting the successful calibration setting will pop up.
Click OK to close the message box.
-- If the obtained calibration coefficient of any parameter is not within the
range of 75%~125% or the CV% of any calibrated parameter does not meet
the repeatability, the calibration coefficient will not be saved and a dialogue
box indicating invalid new calibration coefficient will pop up. Click Yes to
close the dialogue box and repeat the calibration operations.
11. (Optional) Click Print to print the calibration results.
8.3.3 AUTO CALIBRATION USING FRESH BLOOD SAMPLES

Complete the calibration using fresh blood samples as per the following proce-
dure:
2. Click Fresh Blood.
The fresh blood sample calibration interface pop up, as shown in Figure 133.
Figure 133
Auto Calibration Using
Calibrators
174
3. Prepare 3 to 5 normal fresh blood samples as instructed by 6.4 Sample Col-

lection and Handling.
4. Run each of the prepared samples on the reference instrument three times
at least. Average the results for your reference values.
! Note:
The reference instrument must be a properly running standard analyzer
so as to ensure the accuracy of the reference values.
5. Enter the reference values for the parameters to be calibrated in the corre-
sponding Target textbox.
6. Place the blood sample under the sampling probe, press the aspirate key
on the analyzer to run the samples. The system will calculate the values for
WBC, RBC, HGB, MCV and PLT of the sample. If used in VWB mode, use 20 µl
of calibrator material. If used in Pre-diluted mode, first dispense diluent by
the analyzer into a bullet tube, than add 20 µl of calibrator material into the
bullet tube -prefilled with diluent.
7. Repeat step 6 for 10 times and calculate the counting results for sample No.
1 in the 10 runs. The system will calculate the Mean, CV and Calibration co-
efficient for each parameter of the sample. If the obtained calibration coef-
ficient for any sample is not within the valid range or CV% or any calibrated
parameters does not meet the repeatability, a dialogue box indicating in-
valid new calibration coefficient will pop up when you are selecting other
blood samples. Click Yes to clear the calibration data of the sample. Redo the
calibration or redo after running another sample meeting all criteria.
8. Refer to steps 6~7 and perform the counting operations for the remaining
four blood samples. The system will calculate the Mean, CV and Calibration
Coefficient for each parameter of the remaining 4 blood samples.
9. Click Calculate. The system will calculate the average of the calibration coef-
ficients, namely, the mean calibration coefficient (%), as the new calibration
coefficient based on the five blood samples. You can also check at least three
accurate calibration coefficients and the system will re-calculate the mean
calibration coefficient (%).

Calibration 175
! Note:
The mean calibration coefficient is invalid if its absolute value of deviation
from the original calibration coefficient is greater than or equal to 5%.
10. Click Save.

-- If the mean calibration coefficient is within the valid range (the absolute val-
ue of deviation from the original calibration coefficient is less than 5%), you’ll
be prompted that the mean calibration coefficient is saved successfully.
-- If the mean calibration coefficient is not within the valid range (the absolute
value of deviation from the original calibration coefficient is greater than
or equal to 5%), you’ll be prompted that the mean calibration coefficient is
invalid.
CV% out of standard will not affect the display of calibration coefficient.
11. (Optional) Click Print to print the calibration results.
8.4 Verifying Calibration Coefficients

It is recommended that you take the following steps to verify the calibration
coefficients:
1. Run the calibrator at least three times and check whether the means of the
obtained results are within the expected ranges.
2. Run the low-, normal- and high-level controls each for three times at least,
and check whether the means of the obtained results are within the expect-
ed ranges.
3. Run at least three fresh blood samples with known reference values, each for
six times at least, and check whether the means of the obtained results are
within the expected ranges.
176

Reagent Management 177
9 REAGENT MANAGEMENT
Once the new reagent is connected to the analyzer, you can set the reagent con-
figurations, including validity period, residue volume and reagent barcode on
the Reagent Management interface. Upon the completion of reagent configura-
tion, you can perform the procedures for reagent replacement.
! Note:
-- Reagents can be irritating to the eyes, skin, and mucosa. Wear prop-
er personal protective equipment (e.g. gloves, lab uniforms, etc.) and
follow laboratory safety procedures when handling them in the labo-
ratory.
-- If the reagent accidentally comes in contact with your skin, wash it off
immediately with plenty of water and see a doctor if necessary. Do the
same if you accidentally get any of the reagent in your eyes.
9.1 Accessing the Interface

Click Reagent Management in the menu navigation area, to access the reagent
management setting interface. See Figure 135.
Figure 134
178
Table 20
Parameter NOTE
Current Model Current model of the analyzer.
Parameter Description for
-- Open system
Reagent Management
-- Closed system
Reagent setting procedures for different analyzer mod-
els vary, please refer to chapter 9.2 Setting Reagent In-
formation.
Reagent Name Name of the reagent.
Exp. Date Exp. Date of the unopened reagent will be shown upon
the completion of the reagent settings.
Any reagent, regardless of its container being opened or
not, should not be used beyond this date.
Open-container The date on which the reagent container is opened. The
Date default open-container date is the date on which the re-
agent settings are completed.
Period after The validity period (days) after the reagent container is
opening (PAO) opened. It will be shown upon the completion of the re-
agent settings.
Open-container Expiration date of the opened reagent, and it will be
Exp. Date shown upon the completion of the reagent settings.
Residue Volume The current residue volume of the reagent, and it will
be shown in ml upon the completion of the reagent set-
tings. The unit is ml.
9.2 Setting Reagent Information

Once the new reagent is connected to the analyzer, you should set the reagent
configurations, including validity period, residue volume and reagent barcode
on the Reagent Management interface. Upon the completion of reagent config-
uration, you can perform the procedures for reagent replacement.
Reagent setting procedures for different analyzer models vary. The reagent set-
ting procedures will be presented on the following pages.

Reagent Management 179
9.2.1 SYSTEM REAGENT

For setting procedures for the HC5D system reagent please follow below in-
structions:
1. Select the reagent to be set, and then click Setup. A dialogue box as shown
in Figure 136 pops up.
Figure 136
RF Card Verification
2. Put the RF card attached to reagent packing on the RF card reader in front of
the analyzer. The beeping of the card reader and a pop-up dialogue box as
shown in Figure 137 indicate the successful reagent settings.
Figure 137
Successful Reagent Settings
! Note:
-- The RF card is intended for single use only.
-- If RF card verification fails, please follow the system prompts and use
a valid RF card for re-reading.
3. Click OK.
4. Click Close to exit.
! Note:
Once the reagent settings are successfully completed, the system prompt
at the top right corner of the screen will show that the reagent has not
been replaced. To remove this error, click the error message and then click
Remove Error in the pop-up dialogue box. The analyzer will complete the
replacement of the reagent and remove the error.
180
9.3 Replacing Reagents

After completing the reagent settings, you should perform the reagent replace-
ment operations. You can select to replace one type of reagent at a time or all
reagents. The method is applied as follows:
-- Select a type of reagent to be replaced, and click Replace; or click Replace All
to replace all the reagents.
After the replacement is completed, a message box as shown below will pop up
on the screen.
Figure 138
-- Click OK to close the message box.
! Note:
When you have changed the reagents, run a background check to see if
the results meet the requirement. If RF card verification fails, please fol-
low the system prompts and use a valid RF card for re-reading.

Service 181
10 SERVICE
10.1 Introduction
This analyzer provides multiple maintenance functions for this

purpose. This chapter introduces how to use the provided func-
tions to maintain and troubleshoot your analyzer. Preventive and
corrective maintenance procedures are required to keep the ana-
lyzer in a good operating condition. All the analyzer components
and surfaces are potentially infectious, take proper protective
measures for operation or maintenance.
CAUTION
-- Performing unauthorized maintenance procedures can dam-
age your analyzer. Do not perform any maintenance proce-
dures that are not described in this chapter.
-- In case of problems not specified in this manual, contact Hu-
man customer service department or your local agent for as-
sistance.
-- Only Human-supplied parts can be used for maintenance. For
any question, contact Human customer service department or
your local agent.
-- Exercise caution to avoid contact with the sharp sample probe
when performing maintenance.
WARNING
-- Before turning on the analyzer, make sure the input voltage
meets the requirements.
! Note:
-- After long-distance transportation, the reagent must be allowed to
-- When you have changed the diluents, cleansers or lyses, run a back-
ground check to see if the results meet the requirement.
182
You should replace the reagents when:

-- The system indicates that the reagent is used up
-- The suspicious flag indicates that the reagent in the pipeline is contaminated
-- The reagent is contaminated or expired
-- WBC or RBC bubbles are identified.
You can replace any of the following reagents:
-- HC5D-Diluent
-- HC5D CBC Lyse
-- HC5D Diff Lyse
Do as follows to replace the reagents:

1. Refer to Figure 122 in 7.3.8.1 Electrical Connections for reagent connections.
2. Click the Service icon in the menu page to access the Service interface as
shown in Figure 139.
Figure 139
Service
3. Click Replace Reagent in the Maintenance selection.

• The interface as shown in Figure 140 will pop up on the screen.

Service 183
Figure 140
Reagent Replacement
4. Click the name of the reagent that needs to be replaced, such as Replace All
Reagents. After the replacement is completed, the following message box
will pop up.
Figure 141

6. Perform the above procedures to replace other reagents if necessary.
! Note:
-- After long-distance transportation, the reagent must be allowed to
-- When you have changed the diluents, cleansers or lyses, run a back-
ground check to see if the results meet the requirement.
184
10.1.1 CLEANING
Clean corresponding parts according to the actual situation:
-- WBC bath
You should clean the WBC bath when:
-- The background of the scattergram has abnormal excessive cells
-- the background of WBC- and/or HGB-specific parameters exceeds the refer-
ence range
-- RBC bath
When the background of RBC- and (or) PLT-specific parameters exceeds the ref-
erence range, you should clean the RBC bath.
-- Flow chamber
When the background of the scattergram has abnormal excessive cells, or bad
differential of WBC, you should clean the flow chamber.
-- Sample probe
When the sample probe is dirty, you should clean the sample probe.
The cleaning procedures are as follows:
1. Click the Service icon in the menu page to access the Service interface.
Figure 142
Service

Service 185
2. Click Clean in the Maintenance selection, an interface as shown in Figure 142

will pop up on the screen.
Figure 143
Cleaning
3. Click the icon of the part that needs to be cleaned, such as Clean Sample
Probe. When the system cleaning is complete, the message box will pop up
to show that the cleaning is done.
Figure 144

5. Perform the above procedures to clean other components if necessary.
10.1.2 MAINTENANCE
Maintenance of the analyzer includes: unclogging, cleanser soak, cleanser soak
for WBC channel and cleanser soak for RBC channel.
10.1.2.1 Unclogging
If clogging is found, or it is suspected that the counting results are not accurate
due to aperture clogging, you can perform the unclogging operations.
The unclogging procedures are shown as follows:
186
Figure 145
Service
2. Click Maintain in the Maintenance selection.

Figure 146
Maintenance
3. Click the Unclog icon.
The system will start clogging, and a message box will pop up. After the unclog-
ging is completed, a message box will pop up to show that the clogging is done.
Figure 147

Service 187

5. Perform the above procedures to continue unclogging if necessary.
10.1.2.2 Cleanser Soak

The cleanser soak should be performed under the following circumstances:
-- When the problems including the background results exceed the Ref. Range,
bad differential of scattergram and clogging still exist after other mainte-
nance procedures have been adopted.
-- Analyzer has been running for more than 24 hours. The cleanser soak proce-
dures are shown as follows.
Figure 148
Service
2. Click Maintain in the Maintenance selection.

The interface as shown in the following picture will pop up on the screen.
188
Figure 149
3. Click the icon of Cleanser Soak.

4. A dialogue box as shown below will pop up.
Figure 150
Cleanser Soak
Figure 151
Cleanser Soak
5. Present the cleanser to the sample probe as per the prompt, and press the
aspirate key or click the Aspirate button. Cleanser soaking... and the soaking
time will appear as shown below. See Figure 152.

Service 189
Figure 152
Cleanser Maintenance Done
6. Click Close.
7. Perform the above procedures to perform the cleanser soak again if neces-
sary.
10.1.2.3 Cleanser Soak for WBC Channel

Probe cleanser soaking for WBC channel can be used to remove the errors for ap-
erture clogging or abnormal scattergram. Please refer to chapter 10.1.2.2 Clean-
ser Soak for performing the operations for cleanser soaking for WBC channel.
10.1.2.4 Cleanser Soak for RBC Channel

In case the RBC distribution histogram is abnormal or the clogging is believed to
exist in the flow chamber, cleanser soak for RBC channel feature can be used as
a means for troubleshooting.
Please refer to chapter 10.1.2.2 Cleanser Soak for performing the operations for
cleanser soaking for WBC channel.
10.2 Comprehensive Device Maintenance

The comprehensive device maintenance feature includes fluidics initialization,
comprehensive device cleaning, emptying fluidics and preparing to ship.
190
10.2.1 FLUIDICS INITIALIZATION

After maintaining the fluidic system or replacing a main part of the analyzer,
you should perform this procedure to initialize the fluidic system.
Do as follows to perform the fluidics initialization:
Figure 153
Service
2. Click Comprehensive Device in the Maintenance selection.

• The interface as shown below will pop up on the screen.
Figure 154
3. Click the icon of Fluidics Initialization.

The analyzer starts to perform the fluidics initialization procedure. After the ini-
tialization is complete, a message box will pop up.

Service 191
Figure 155
4. Click OK.
10.2.1.1 Clean Fluidics

If the background results of parameters are out of the background range, the
comprehensive device cleaning should be cleansed.
Procedures for comprehensive device cleaning are shown as below:
The interface as shown below will pop up on the screen.
Figure 156

The analyzer starts to perform the fluidics cleaning procedure. After the clean-
ing is completed, the following message box will pop up.
Figure 157
4. Click OK.
192
10.2.1.2 Empty Fluidics

This function enables the device to empty fluidics to prevent crystallization and
maintain device performance when the device has not been used for more than
one week. Procedures for emptying fluidics are shown as below:
Figure 158
3. Click the icon of Empty Fluidics.

• A dialogue box will pop up as shown below.
Figure 159
4. Click Yes.
• A dialogue box will pop up as shown below.
Figure 160
5. Remove all reagent pickup tube assemblies according to the prompt, and
then click OK to start emptying the fluidic system. After the emptying is
complete, a message box will pop up.

Service 193
6. Place the [O/I] switch at the left side of the main unit in the [O] position.
WARNING
10.2.1.3 Prepare to Ship

If the analyzer is not to be used for over two weeks or needs be transported over
a long distance (transporting time>2h), you should perform this procedure.
Do as follows to perform the prepare-to-ship procedure:
The interface as shown below will pop up on the screen.
Figure 161
3. Click the icon of Prepare to Ship.

A dialogue box will pop up as shown below.
Figure 162
4. Click Yes.
194
Figure 163
5. Remove all reagent pickup tube assemblies according to the prompt, and
then click OK to start emptying the fluidic system. After the emptying is
complete, a message box will pop up.
Figure 164
6. Place all reagent pickup tube assemblies into the distilled water, and then
click OK to start priming.
! Note:
-- Be sure to use distilled water in order to ensure the normal use of the
device in the future. In addition, the beaker holding the distilled water
needs to be cleaned thoroughly.
-- The diluent pipe and lyse pipes should be stored separately in two
beakers. System performs the filling operation. After the filling is com-
pleted, the following dialogue box will pop up.

Service 195
Figure 165
7. Take out the diluent and lyse pipes from the distilled water as per the prompt,
then click OK.
A dialogue box will pop up to prompt you to power off the device.
! Note:
Prepare to ship done. Please power off the analyzer!
1. Place the [O/I] switch at the left side of the main unit in the [O] position.
WARNING
10.2.2 AUTO CLEAN

There will be a certain amount of contamination accumulated after running
a certain amount of samples without shutting down the analyzer. When the
sample count amounts to over 100, the analyzer will perform the cleaning pro-
cedure automatically once, and a prompt will be displayed on the screen. In ad-
dition, the analyzer will perform the auto clean procedures if there has been no
fluidics sequential operation for more than one hour.
! Note:
Prepare to ship done. Please power off the analyzer!
196
10.2.3 AUTO PROMPT FOR CLEANSER SOAK

If the analyzer has been running for more than 24 hours but hasn’t performed
cleanser maintenance when the auto maintenance time is reached, the system
will prompt to perform cleanser soak immediately, so as to prevent the accumu-
lation of contamination.
-- Click Yes, then you can perform the cleanser maintenance as per the prompt
and the description in 10.1.2.2 Cleanser Soak.
-- Click No, then the system will remind you every 10 minutes until you per-
form the maintenance.
! Note:
-- At the Self-test or Status interface, the analyzer does not ask for con-
firmation to perform the cleanser soak.
-- If the analyzer is running or has problems when the conditions of auto
prompt for cleanser soak is satisfied, the analyzer will prompt again
after the current operation is completed or the problems are resolved.
-- After cleanser soak is completed, the accumulative count values will
be cleared automatically.
-- Cleanser soak is an important step in comprehensive device mainte-
nance. It is recommended not to stop soaking halfway.
10.2.4 AUTO SLEEP

When the fluidics system stops working for 60 minutes (default setting), the
analyzer will enter the sleeping status automatically. You can change the wait-
ing time for auto sleeping as needed, see 7.3.3.4 Auto Maintenance. When the
analyzer is in the sleep mode, a prompt will be displayed on the screen. Touch
the screen or press the aspirate key on the analyzer to wake it up.
-- If it is the time to auto sleep but the analyzer is error status, then only after
the error is removed will auto sleep start accordingly.
-- Different maintenances will be performed by the analyzer automatically
when exiting the sleep mode, and the exiting time depends on how long the
analyzer was in the sleep mode.
-- If errors occur when you are trying to cancel the auto sleep of the analyzer,
please refer to chapter 11 Troubleshooting for solving the problems.

Service 197
10.3 Self-test
This feature is to test if some important components of the device can function
properly or not, including syringe and sampling assembly self-test, pressure and
vacuum self-test, valve self-test and other self-test.
Note:
! If the testing result is abnormal, you should try again for several times;
if the abnormalities persist, please contact Human customer service
department or your local agent.
10.3.1 SYRINGE AND SAMPLING MECHANISM

You can test the performance of all syringes and sampling mechanisms.
The self-inspection procedures are shown as below:
2. Click Syringe Self-test in the Self-test selection.
Figure 166
Syringe
3. Click the part that needs to be tested, e.g. Sample Syringe, and wait for the
self-inspection results. After the self-test is completed, a dialogue box will
pop up to show the self-test results.
Figure 167
Syringe Self-test Results

198
10.3.2 PRESSURE AND VACUUM

This feature is to test the pressure and vacuum inside the device.
Procedures for pressure (or vacuum) self-inspection are shown as below:
2. Click Pressure Self-test in the Self-test selection.
Figure 168
Pressure and Vacuum Self-in-
spection
3. Click Pressure (or Vacuum).
The system will perform the corresponding self-test operations. After the self-
test is completed, a dialogue box will pop up to show the self-test results.
Figure 169

Service 199
10.3.3 VALVE & PUMP

When controlling the switches of different valves (pumps), you can judge if the
valves (pumps) are operating properly by the sound of opening, closing or man-
ually touching the corresponding valves (pumps).
The procedures for valve self-inspection are shown as follows:
2. Click Valve/Pump Self-test in the Self-test selection.
Figure 170
Valve Self-test
3. Click the desired valve number (e.g. 1), then confirm whether it works prop-
erly by the sound of its opening and closing.
10.3.4 OTHERS
You can perform the self-test for RBC aperture voltage.
RBC aperture voltage
The self-test procedure of RBC aperture voltage is shown as below:
2. Click Other Self-test in the Self-test selection.
Figure 171
Pressure and Vacuum
Self-inspection
200
3. Click RBC Aperture Voltage to start self-test. The system will perform the
corresponding self-test operations. After the self-inspection is completed, a
dialogue box will pop up to show the self-inspection results.
Figure 172
RBC Aperture Voltage Self-test
Results
RF Card Reader
You can carry out a self-test on its built-in RF card reader. The operation proce-
dures are as shown below.
2. Click Other Self-test in the Self-test selection.
3. Click the icon of RF Reader to start self-test.
A dialogue box will pop up as shown below.
Figure 173
Syringe Self-test Results
10.4 System Status

You can view the current status information of the analyzer in the Status selec-
tion, including temperature, voltage and current, and version information.

Service 201
10.4.1 TEMPERATURE
2. Click Temperature in the Status selection.
Figure 174
View Temperature Status
User can view the current temperature information of the analyzer, including
the temperature of preheating bath temperature, ambient temperature and the
temperature of the optical system. If the results of the temperature testing ex-
ceed the normal range, they will be highlighted by the red background.
10.4.2 VOLTAGE AND CURRENT

2. Click Voltage/Current in the Status selection.
Figure 175
Voltage and Current
You can view the voltage and current information of the analyzer. The voltage
or current value that exceeds the normal range will be displayed in a red back-
ground.
202
10.4.3 DISK INFORMATION

You can view the disk information of the analyzer, including disk name, capacity
and used space. Specific steps are shown below.
2. Click Disk Info in the Status selection.
The disk information interface displays. See Figure 176.
Figure 176
Disk Information
10.5 Log
In the Log interface, you can view the records of Set Paras, Other Logs, Fault Logs
and All Logs.
-- If a new record is added when the log is full, the newest record will overwrite
the oldest one automatically.
-- The administrator can view both his/her own operation logs and the general
users’ operation logs, while the general users can only review their own op-
eration logs.
-- The log can keep records of up to 5 years.

Service 203
10.5.1 ALL LOGS

2. Click All Logs in the Log selection.
You can view all logs (visible to the users of the current access level).
Figure 177
All Logs
3. Select the dates in the two date textboxes, and then you can view the all
logs within the date range, including operation time, log information and
the operator.
10.5.2 PARAMETER REVISION LOGS

2. Click Set Paras in the Log selection.
You can view the parameter revision logs (which can be viewed by the user with
the current level of access) within a specified date range.
204
Figure 178
Parameter Revision Logs
3. Select the dates in the two date textboxes, and then you can view the pa-
rameter revision logs within the date range, including the revision date and
time, revision summary and the operator.
10.5.3 FAULT LOGS

2. Click Fault Logs in the Log selection.
You can view all logs (visible to the users of the current access level).
Figure 179
Fault Logs

Service 205
3. Select the dates in the two date textboxes, and then you can view the fault
logs within the date range, including date and time when the faults occur,
fault description and the operator.
10.5.4 OTHER LOGS

2. Click Other Logs in the Log selection.
You can view other logs besides parameter revision logs and fault logs.
Figure 180
Other Logs
3. Select the dates in the two date textboxes to view the logs within the date
range, including operation date and time, operation records and the opera-
tor.
10.6 Data Cleanup

You can clean up the data stored in the analyzer. Specific steps are shown below.
2. Click Data Cleanup in the Other selection.
The data cleanup interface displays. See Figure 181.

206
Figure 181
Data Cleanup
3. Click the End time combo box, set the date range of the data to be cleaned
up in the pop-up dialogue box.
Figure 182
-- The input sequence of the controls is the same with the date format on
the top right corner of the dialogue box. For example, if the data format is
yyyy/MM/dd, you should input the data in the sequence of year, month, and
day.
-- Click or to select a date.
-- Click Cancel to cancel the process. The data will not be cleaned up.
-- For example, If the End time is set to 2016/03/31, the data generated from
system installation
-- Date to 31 March 2016 will be cleared.
4. Click OK to save the settings and close the dialogue box.
5. Select the data to be cleaned up.
You can clean up the following data:

Service 207
-- Counting results
-- L-J QC results
-- X-B QC results
-- Log files
-- Scattergram
Click Apply or OK.

The interface pops up a dialogue box as shown below, indicating the cleanup is
completed.
Figure 183
10.7 Version Information

You can view the current version information of all parts of the analyzer, and
export the version information to a USB flash disk. Detailed steps are shown
below:
2. Click Version Info in the Other selection.
Version information interface will pop up on the screen. See Figure 184.
Figure 184
Version Information
208

4. Click Export, and select the export path in the dialogue box, and then enter
the file name. The file will be exported to the root directory of the USB flash
disk (/udisk/sda1) by default as shown below.
Figure 185
5. Click Save to start exporting.

• After Export is completed, the message box as shown below will pop up.
Figure 186
6. Click OK to exit.

Service 209
10.8 Touch Screen Calibration

When the touch screen has offset, it needs to be recalibrated. Detailed steps are
shown below:
2. Click Touch Screen Cal. in the Cal selection.
3. Click the calibration point “+” on the screen in order.
When the calibration point disappears and the system return to the service
screen, it indicates the completion of the calibration.
10.9 Exporting Host Information File

In the use of the analyzer, when errors occur and can not be removed, it’s recom-
mended that you export the host information to a USB flash disk and send the
file to Human customer service engineer. Specific steps are shown below.
1. Insert a USB flash disk into the USB interface on the analyzer.
3. Click Download in the Debug selection.
The host_download.tar file is exported to the root directory of the USB flash
disk.
4. Send the host_download.tar file to Human customer service engineer for
handling.
210

Troubleshooting 211
11 TROUBLESHOOTING
11.1 Introduction
This chapter contains information that is helpful in locating and resolving prob-
lems that may occur during the operation of your analyzer.
This chapter is not a complete service manual and is limited to problems that
are readily diagnosed and/or corrected by the user of the analyzer. If the recom-
mended solution fails to solve the problem, contact Human customer service
department or your local agent.
11.2 Dealing with Error Messages

In the use of the analyzer, when the software detects abnormalities, an er-
ror message will be displayed on the upper right of the screen as shown in
Figure 187 and the main unit will sound an alarm.
Figure 187
Error Messages
You can refer to the following steps to deal with the error messages.
1. Click the error message area.
2. Touch the screen to disable the beep.
3. Click Remove Error. Normally, the system will automatically remove the er-
rors. For errors which cannot be removed automatically, you can take appro-
priate actions by following the error help information or 11.3 Error Message
Reference.
212
11.3 Error Message Reference

Possible errors and the corresponding help information are shown in Table 21.
Table 21
Problem Name Troubleshooting Information
-12V power is not 1. Please power off the analyzer directly and restart later.
Error Message Reference
working properly. 2. If the error still exists, contact our customer service
department.
Optical 1. Close the optical assembly cover.
assembly cover is 2. Click the Remove Error button to remove this error.
open. 3. If the error still exists, contact our customer service
department.
The CC source 1. Please power off the analyzer directly and restart later.
voltage is 2. If the error still exists, contact our customer service
abnormal. department.
Abnormal laser 1. Please power off the analyzer directly and restart later.
current. 2. If the error still exists, contact our customer service
department.
Startup failure. 1. Click the Remove Error button to remove this error.
2. If the error still exists, contact our customer service
department.
Startup 1. Click the Remove Error button to remove this error.
initialization is not 2. If the error still exists, contact our customer service
executed. department.
The right-side door 1. Close the right side door.
is open. 2. Click the Remove Error button to remove this error.
department.
+12V power is not 1. Please power off the analyzer directly and restart later.
working properly. 2. If the error still exists, contact our customer service
department.
HC5D-Diluent 1. Check if the HC5D-Diluent expires. If so, replace it with
expiration. a new container of HC5D-Diluent.
2. Click the Remove Error button, the Reagent Manage-
ment screen will be displayed.
3. Set the reagent information by referring to chapter 9
Reagent Management.
department.

Troubleshooting 213
HC5D CBC Lyse 1. Check if the HC5D CBC Lyse expires. If so, replace it
expiration with a new container of HC5D CBC Lyse.
Reagent Management.
department.
HC5D Diff Lyse 1. Check if the HC5D Diff Lyse expires. If so, replace it
expiration with a new container of HC5D Diff Lyse.
Reagent Management.
department.
Preheating bath 1. Click the Remove Error button to remove this error.
temperature out of 2. If the error still exists, contact our customer service
working range. department.
Abnormal HGB Please contact our customer service department.
background volt-
age.
Abnormal RBC ap- 1. Click the Remove Error button to remove this error.
erture voltage. 2. If the error still exists, contact our customer service
department.
Abnormal back- 1. Check whether the diluent is contaminated.
ground. 2. If not, click the Remove Error button to remove the error.
department.
Failed to read 1. Click the Remove Error button to remove this error.
sample syringe 2. If the error still exists, contact our customer service
parameter. department.
Failed to configure 1. Click the Remove Error button to remove this error.
sample syringe 2. If the error still exists, contact our customer service
Sample syringe 1. Click the Remove Error button to remove this error.
timeout 2. If the error still exists, contact our customer service
department.
Sample syringe is 1. Click the Remove Error button to remove this error.
busy. 2. If the error still exists, contact our customer service
department.
Vertical motor in- 1. Click the Remove Error button to remove this error.
struction parame- 2. If the error still exists, contact our customer service
ter error. department.
214
Failed to read ver- 1. Click the Remove Error button to remove this error.
tical motor param- 2. If the error still exists, contact our customer service
eter. department.
Vertical motor 1. Click the Remove Error button to remove this error.
department.
Failed to read the 1. Click the Remove Error button to remove this error.
remaining steps of 2. If the error still exists, contact our customer service
vertical motor. department.
The vertical motor 1. Click the Remove Error button to remove this error.
is busy. 2. If the error still exists, contact our customer service
department.
Failed to read 1. Make sure the temperature sensor is correctly installed.
preheating bath 2. Click the Remove Error button to remove the error.
temperature. 3. If the error still exists, contact our customer service
department.
Failed to read opti- 1. Make sure the temperature sensor is correctly installed.
cal system temper- 2. Click the Remove Error button to remove the error.
ature. 3. If the error still exists, contact our customer service
department.
Failed to read am- 1. Make sure the temperature sensor is correctly installed.
bient temperature. 2. Click the Remove Error button to remove the error.
department.
Waste is full. 1. Empty the waste container or install a new waste con-
tainer.
2. Click the Remove Error button to remove the error.
department.
The setting tem- 1. Click the Remove Error button to remove this error.
perature of optical 2. If the error still exists, contact our customer service
system out of department.
range.
Optical system 1. Click the Remove Error button to remove this error.
temperature out of 2. If the error still exists, contact our customer service
working range. department.
Flow cell clog. 1. Click the Remove Error button to remove this error.
department.
Failed to read 1. Click the Remove Error button to remove this error.
horizontal motor 2. If the error still exists, contact our customer service

Troubleshooting 215
Failed to configure1. Click the Remove Error button to remove this error.
Horizontal motor 2. If the error still exists, contact our customer service
Horizontal motor 1. Click the Remove Error button to remove this error.
department.
The optocoupler of 1. Click the Remove Error button to remove this error.
the horizontal mo- 2. If the error still exists, contact our customer service
tor is not working department.
properly.
The horizontal 1. Click the Remove Error button to remove this error.
motor is busy. 2. If the error still exists, contact our customer service
department.
No HC5D-Diluent 1. Check whether the HC5D-Diluent container is empty.
If so, install a new container of HC5D-Diluent.
department.
HC5D CBC Lyse 1. Check whether the HC5D CBC Lyse is running out or
running out or air there are air bubbles in the inlet tubing of HC5D CBC
bubbles in inlet Lyse. If it is running out, install a new container of HC5D
tubing. CBC Lyse; If there is still plenty of HC5D CBC Lyse or there
are bubbles, perform step 2.
department.
HC5D Diff Lyse 1. Check whether the HC5D Diff Lyse is running out or
running out or air there are air bubbles in the inlet tubing of HC5D Diff Lyse.
bubbles in inlet If it is running out, install a new container of HC5D Diff
tubing. Lyse; If there is still plenty of HC5D Diff Lyse or there are
bubbles, perform step 2.
department.
HC5D-Diluent not 1. Click the Remove Error button to remove this error.
replaced. 2. If the error still exists, contact our customer service
department.
HC5D CBC Lyse not 1. Click the Remove Error button to remove this error.
department.
HC5D Diff Lyse not 1. Click the Remove Error button to remove this error.
department.
216
DIFF probe clog- 1. Click the Remove Error button to remove this error.
ging 2. If the error still exists, contact our customer service
department.
Abnormal 12V driv- 1. Please power off the analyzer directly and restart later.
ing power supply. 2. If the error still exists, contact our customer service
department.
Abnormal 24V driv- 1. Please power off the analyzer directly and restart later.
ing power supply. 2. If the error still exists, contact our customer service
department.
Insufficient 1. Check whether the HC5D-Diluent container is empty.
HC5D-Diluent. If so, install a new container of HC5D-Diluent.
Reagent Management.
department.
Insufficient HC5D 1. Check whether the HC5D CBC Lyse container is empty.
CBC Lyse. If so, install a new container of HC5D CBC Lyse.
Reagent Management.
department.
Insufficient HC5D 1. Check whether the HC5D Diff Lyse container is empty.
Diff Lyse. If so, install a new container of HC5D Diff Lyse.
Reagent Management.
department.

Troubleshooting 217
Appendix A Specifications
A.1 Classification
According to the CE classification, the Auto Hematology Analyzer belongs to in
vitro diagnostic medical devices, rather than those covered by Annex II and de-
vices for performance evaluation.
A.2 Reagents
Reagent Type Reagent Name Table 22

Diluent HC5D-Diluent
Lyse HC5D Diff Lyse
HC5D CBC Lyse
Medical cleanser Cleanser
A.3 Parameters
Parameter Abbreviation Default Unit

Table 23
White Blood Cell count WBC 109/l
Number of Neutrophils Neu# 109/l
Number of lymphocytes Lym# 109/l
Number of Monocytes Mon# 109/l
Number of Eosinophils Eos# 109/l
Number of Basophils Bas# 109/l
Number of Abnormal Lymphocytes ALY# (RUO) 109/l
Number of Large Immature Cells LIC# (RUO) 109/l
Percentage of Neutrophils Neu% %
Percentage of Lymphocytes Lym% %
Percentage of Monocytes Mon% %
Percentage of Eosinophils Eos% %
Percentage of Basophils Bas% %
Percentage of Abnormal Lymphocytes ALY% (RUO) %
Percentage of Large Immature Cells LIC% (RUO) %
Red Blood Cell count RBC 1012/l
Hemoglobin Concentration HGB g/l
Hematocrit HCT %
Mean Corpuscular Volume MCV fl
Mean Corpuscular Hemoglobin MCH pg
Mean Corpuscular Hemoglobin MCHC g/l
Concentration
Red Blood Cell Distribution Width - RDW-SD fl
Standard Deviation ( RDW-SD)
218
Red Blood Cell Distribution Width - RDW-CV %

Coefficient of Variation (RDW-CV)
Platelet count PLT 109/l
Mean Platelet Volume MPV fl
Platelet Distribution Width PDW None
Plateletcrit PCT %
Platelet-large cell count P-LCC 109/l
Platelet-large cell ratio P-LCR %
White Blood Cell Histogram WBC Histogram None
Red Blood Cell Histogram RBC Histogram None
Platelet Histogram PLT Histogram None
Basophils Scattergram BASO Scattergram None
DIFF Scattergram DIFF Scattergram None
A.4 Performance Specifications

A.4.1 Display Range
Table 24 Parameter Display Range

WBC 0-999 109/l
Neu# 0-999 109/l
Lym# 0-999 109/l
Mon# 0-999 109/l
Eos# 0-999 109/l
Bas# 0-999 109/l
ALY# (RUO) 0-999 109/l
LIC# (RUO) 0-999 109/l
Neu% 0-99.9 %
Lym% 0-99.9 %
Mon% 0-99.9 %
Eos% 0-99.9 %
Bas% 0-99.9 %
ALY% (RUO) 0-99.9 %
LIC% (RUO) 0-99.9 %
RBC 0-18 1012/l
HGB 0-300 g/l
HCT 0-80 %
MCV 0-250 fl
MCH 0-999.9 pg
MCHC 0-9999 g/l
RDW-SD 0-999.9 fl
RDW-CV 0-99.9 %
PLT 0-5000 109/l
MPV 0-99.9 fl
PDW 0-999.9 %
PCT 0-0.999 %

Troubleshooting 219
P-LCC 0-5000 109/l

P-LCR 0-99.9 %
A.4.2 Normal Background

Table 25
Parameter Normal Background
WBC ≤0.2×109/l
RBC ≤0.02×1012/l
HGB ≤1g/l
PLT ≤10×109/l
HCT ≤0.5%
A.4.3 Linearity Range
Parameter Linearity range Deviation range (Whole blood mode) Table 26

(0.00~100.00)×109/l ±0.30×109/l or ±5%
WBC
(100.01~300.00)×109/l ±10%
RBC (0.00~8.50)×1012/l ±0.05×1012/l or ±5%
HGB (0~250) g/l ±2g/l or ±2%
(0~1000)×109/l (RBC≤7.0) ±10×109/l or ±8%
PLT
1001~3000×109/l (RBC≤7.0) ±12%
±2% (HCT value) or ±3% (deviation
HCT 0~67%
percent)
A.4.4 Analytical Range

Table 27
Parameter Analytical Range
WBC (0.2-300) x109/l
RBC (0.02-8.50) x1012/l
HGB (1-250) g/l
PLT (10-3000) x109/l
HCT 0.5%-67%
A.4.5 Repeatability
These repeatability requirements apply only to the situation in which a qualified
sample has been run for 11 times and the results of the 2nd to 11th runs are used
to calculate the repeatabilities.
Parameter Condition Whole Blood Repeatability (CV%/ Table 28

absolute deviation d*)
WBC (4.0~15.0)×109/l ≤2.0%
Neu% 50.0%~60.0% ±4.0 (absolute deviation)
220
Lym% 25.0%~35.0% ±3.0 (absolute deviation)

Mon% 5.0%~10.0% ±2.0 (absolute deviation)
Eos% 2.0%~5.0% ±1.5 (absolute deviation)
Bas% 0.5%~1.5% ±0.8 (absolute deviation)
RBC (3.50~6.00)×1012/l ≤1.5%
HGB (110~180) g/l ≤1.5%
PLT (150~500) ×109/l ≤4.0%
MCV (70~120)fl ≤1.0%
MPV - ≤4.0
A.4.6 Carryover
Table 29 Parameter Carryover

WBC ≤0.5%
RBC ≤0.5%
HGB ≤0.5%
PLT ≤1.0%
HCT ≤0.5%
A.5 Input/output Device
WARNING
Accessory equipment connected to the analogue and digital in-
terfaces must comply with the relevant Safety and EMC stand-
ards (e.g., IEC 60950 Safety of Information Technology Equipment
Standard and CISPR 22 EMC of Information Technology Equip-
ment Standard (CLASS B)).Anyone who connects additional equip-
ment to the signal input or output ports and configures an IVD
system is responsible for ensuring that the system works properly
and complies with the safety and EMC requirements. If you have
any problem, consult the technical services department of your
local agent.
-- Analyzer
-- Touch screen: 10.4 inches embedded touch screen with a resolution of 800×600
-- One LAN interface
-- USB interfaces
-- Power
-- Voltage: A.C 100V~240V
-- Input power: ≤200VA
-- Frequency: 50/60 Hz
-- Keyboard (Optional, USB)

Troubleshooting 221
-- Mouse (Optional, USB)

-- External barcode scanner (optional, USB)
-- Printer (optional, USB)
-- USB flash disk (optional, USB)
Test Item Test Standard Test Requirement Table 30

Conducted EN 61326-1:2013 1Mode-Class B
Disturbance EN 61326-2-6:2013
Radiated EN 61326-1:2013 1Mode-Class B
Disturbance EN 61326-2-6:2013
Harmonic Current EN 61326-1:2013 Class A
EN 61326-2-6:2013
Voltage Fluctuation EN 61326-1:2013 /
and Flicker EN 61326-2-6:2013
ESD Immunity EN 61326-1:2013 air discharge: ±2, ±4, ±8kV
EN 61326-2-6:2013 contact discharge: ±2, ±4kV
Radiated EN 61326-1:2013 80MHz-1GHz,1.4GHz-2GHz
Electromagnetic EN 61326-2-6:2013 3V/m
Field Immunity 80%AM(1kHz);
2GHz-2.7GHz
1V/m
80%AM(1kHz)
EFT Immunity EN 61326-1:2013 1kV 5/50 ns Tr/Th 5kHz
EN 61326-2-6:2013 repetition frequency
Surge Immunity EN 61326-1:2013 1.2/50(8/20)μs Tr/Th 1kV L-N
EN 61326-2-6:2013 2kV L-PE,N-PE
Conducted EN 61326-1:2013 0.15MHZ~80MHZ 3V(r.m.s)
Immunity EN 61326-2-6:2013 (unmodulated)
Voltage Dips and EN 61326-1:2013 Voltage dips: 0%UT, 1cycle
Interruptions EN 61326-2-6:2013 40%UT, 5cycle
Immunity 70%UT, 25cycle
Voltage interruption:
<5%UT, 250cycle
A.6 EMC Description

This equipment complies with the emission and immunity requirements of the
IEC 61326-1:2012, EN 61326-1:2013, IEC 61326-6-2-6:2012 and EN 61326-2-
6:2013. This equipment 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.
The test items, standards and requirements on electromagnetic compatibility
for the environment are shown in the table below.
222
A.7 Environment Conditions
! Note:
Be sure to use and store the analyzer in the specified environment.
Table 31 Operating Storage Running

Environment Conditions
Environment Environment Environment
Ambient temperature 15°C~30°C -10°C~40°C 5°C~40°C
Relative humidity 20%~85% 10%~90% 10%~90%
Atmospheric pressure 70kPa~106kPa 50kPa~106kPa 70kPa~106kPa
A.8 Dimensions and Weight
Figure 188
Height
Depth
Width
Table 32
Analyzer Dimensions and Weight
Width (mm) 364
Height 498
Depth (mm) 431
Weight (kg) 28

Appendix 223
12 APPENDIX
Appendix B Terms and Abbreviations
CWB Capillary Whole Blood
PD Predilute
VWB Venous Whole Blood
No. Parameter Quantity Unit

Table 33
1 Auto Hematology Analyzer 1 PCS
2 Power Cable 1 PCS
3 Peripheral Grounding Cable 1 PCS
4 Operator’s Manual 1 PCS
5 Quick Operation Guide Card 1 PCS
6 Diluent Adapter Tube 1 PCS
7 Waste Float Adapter Tube 1 PCS
8 HC5D-Diluent (20 l) 1 Bottle
9 HC5D Diff Lyse (500 ml) 1 Bottle
10 HC5D CBC Lyse (200 ml) 1 Bottle
11 Cleanser (50 ml) 1 Bottle
12 Warranty Card 1 PCS
13 Waste container 1 PCS
14 Reagent Operation Guide for Closed System 1 PCS
(for closed systems only)
15 Inspection Record 1 PCS
224

HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 • 65205 Wiesbaden • Germany
Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100
eMail: [email protected] • www.human.de

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HumaCount 5D

Cat No. 16450/1

SERVICE UND SUPPORT

3 ROUTINE UTILIZATION AND MEASUREMENT 21

5.4.9 Customized Parameters 83

9 REAGENT MANAGEMENT 177

10.6 DATA CLEANUP 205

1.2 User Warranty

1.3 Intended Use of the Instrument

1.4 General Safety Warnings

1.5 Disposal Management Concept

HumaCount 5D | User manual

1.6 Biohazard Warning

1.7 Instrument Disinfection

1.8 Who Should Read This Manual of HumaCount 5D

1.9 Special Symbols used in this Manual and on the Analyzer

Follow the instruction in the manual related to the

Follow the instruction in the manual related to the

Follow the instruction in the manual related to the

When you see... It means...

Exercise caution to prevent puncture

Laser radiation warning:

Instruction for Moving

HumaCount 5D | User manual

Alternating current (AC)

For in vitro diagnosis only

European CE declaration of conformity

Humidity level for storage

Atmospheric pressure level for storage

Consult the operator’s manual

Let this side face upward

Fragile, handle with care

The analyzer, after being scrapped, should not be disposed

HumaCount 5D | User manual

2.2 Installation Requirements

Installation requirements for the analyzer are as follows.

Installation Requirements Table 1

Space (In -- At least 50 cm from each side, which is the preferred

HumaCount 5D | User manual

2.5 Who Should Read This Manual

2.6 Structure of the Analyzer

-- This sign warns of laser radiation. Do not look directly at the

2.6.1 MAIN UNIT

HumaCount 5D | User manual

2.6.2 TOUCH SCREEN

2.6.3 ASPIRATE KEY

2.6.4 POWER/STATUS INDICATOR

2.6.5 POWER SWITCH

HumaCount 5D | User manual

2.6.6 USB INTERFACE

2.6.7 NETWORK INTERFACE

2.6.8 EXTERNAL EQUIPMENT (OPTIONAL)

2.7.1 SCOPE OF SUPPLY

HumaCount 5D Hematology analyzer 1 16450

User Manual 1 16450/1

Peripheral grounding cable 1

2.7.2 OPTIONAL ACCESSORIES

2D Barcode Scanner 16430/11

Laser Printer 18993L

3 ROUTINE UTILIZATION AND MEASUREMENT 21

5.4.9 Customized Parameters 83

9 REAGENT MANAGEMENT 177

10.6 DATA CLEANUP 205