Гематологический Анализатор HumaCount (Human) РП

HumaCount
| User Manual
|
Cat.No. 17401/1
Revision List of the Manual
No. DATE / Rev. REVISION DESCRIPTION
1 01/2004-04 First edition
2 02/2006-01 Reagents
3 03/2008-01 Reformat
4 04/2008-03 Diagnostic flags, requires software 3.23 or higher

5 05/2009-11 New pump, USB added to backup options
6 06/2011-11 Correction Prediluted Mode
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1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operator’s hand as well as at the
maintenance operator’s availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the ”GENERAL SAFETY
WARNINGS”, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives 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 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, diskettes, 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.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
3 INTENDED USE OF THE INSTRUMENT [IVD]

The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
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 ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use 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 instrument, 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 instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
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5 DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
6 INSTRUMENT DISINFECTION
Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be
considered at least potentially infectious. 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.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authority’s interventions.
7 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
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NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. 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.
BIOHAZARD
The „BIOHAZARD“ warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authority’s interventions.
HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: human@human.de · www.human.de
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Contents
1 INTRODUCTION, INTENDED USE 3

2 DESCRIPTION OF THE ANALYZER AND THE REAGENT 4
2.1 Parts of the Analyzer 4
2.1.1 Front Panel 5
2.1.2 Rear Panel 6
2.2 Reagents 7
2.3 Fluidic Schematics 7
2.4 Function of Fluidics 8
2.5 Control Panels 8
2.5.1 Sampling Bar 8
2.5.2 Status LED 8
2.5.3 Display 8
2.5.4 Function key description 9
3 DESCRIPTION OF THE SOFTWARE 10
3.1 General 10
3.2 Menu System 10
3.3 Menu Structure 11
4 OPERATING PRINCIPLES 12
4.1 Impedance Method 12
4.2 Principle of the HGB Measurement 12
4.3 Parameters 13
4.4 Absolute and Linearity Ranges of Measured Parameters 14
5 ANALYZER INSTALLATION PROCEDURES 15
5.1 Unpacking 15
5.2 Connecting Reagent Containers 15
5.3 Connecting Power Cord 15
5.4 Connecting an External Printer 15
5.5 Connecting the Instrument to a Host Computer 15
5.6 Turning the Instrument ON 15
5.7 Display Contrast Setting 15
5.8 Reagent Priming 16
5.9 Turning the Instrument OFF 16
6 SOFTWARE SETTINGS 17
6.1 Customize 17
6.1.1 General Settings 17
6.2 Setting Date and Time 17
6.3 Setting the Name of the Laboratory 18
6.4 Results Units Setting 18
6.5 Setting Reference Limits 18
6.6 Fluid Sensors 20
6.7 Printer Settings 20
6.7.1 Troubleshooting Guide for Printing Problems 22
6.8 User Settings 22
6.8.1 Multi-user Mode 23
7 ROUTINE UTILISATION 24
7.1 Measuring Process 24
7.1.1 Sampling 24
7.1.2 Blank Measurement 24
7.1.3 Calibration 25
7.1.4 Sample Analysis 27
7.1.5 Diagnostic flags 28
7.1.6 Prediluted Mode 30
7.1.7 [LYSE] Boost (for Veterinary Mode) 30
7.2 Quality Control 31
7.2.1 QC Database 32
7.3 Auto Stand-by 32
7.4 Printouts 32
7.5 Patient Results Database Management 33
7.6 Data Back Up 35
7.7 Maintenance 36
7.7.1 Cleaning 36
7.7.2 Priming 36
7.7.3 Draining 36
7.7.4 Manual Cleaning of the Aperture 36
7.7.5 Weekly Maintenance 36
7.8 Diagnostics 38
7.8.1 Device Statistics 38
7.8.2 Self Test 38
7.9 Software Update 39
8 APPENDIX "A": REAGENT SOLUTIONS AND CONSUMPTION 40
9 APPENDIX "B": TECHNICAL SPECIFICATIONS 41
10 APPENDIX "C": FLUIDIC SCHEMATICS 42
11 APPENDIX "D": ACCESSORIES 43
12 APPENDIX “E”: FINDING THE CORRECT [LYSE] VOLUME FOR VETERINARY APPLICATIONS 44
HumaCount | User Manual 2/44

1 INTRODUCTION, INTENDED USE
The HumaCount hematology analyzer is a fully automated cell counter for in vitro diagnostic use. The compact
instrument was developed for small to medium size labs with today’s technology.
The analyzer can process 30 samples per hour with the specified accuracy and reproducibility and has a
2,000 samples storage capacity including histograms.
It is intended to determine the following 18 hematology parameters from a 25 μl whole blood sample:
− WBC - LYM# - MID# - GRA# - LYM% - MID% - GRA% (three-part WBC differential)
− HGB - RBC - HCT - MCV - RDW - MCH - MCHC
− PLT - MPV - PCT - PDW
The instrument has a built-in veterinary software module, which allows measuring and determining 18 hemato-
logy parameters (three-part WBC differential) from different animal blood samples.
The interfaces allow sending results to an external printer (parallel port), to a host computer (serial port). By using
the integrated 3½” floppy disk drive or the USB port, the instrument can be easily upgraded at any time and it can
backup data to floppy disk or USB device.
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2 DESCRIPTION OF THE ANALYZER AND THE REAGENT
2.1 Parts of the Analyzer

The HumaCount Hematology Analyzer consists of three main parts:
− Fluidic System: performs aspirating, sampling, diluting, mixing, lysing and rinsing, and additionally generates
the regulated measuring vacuum.
− Data Processing System: counts and measures blood parameters, generates and stores results and histograms.
− Control Panels: include display, keyboard, parallel (external printer), and serial (computer) interface.

2.1.1 Front Panel
2.1.1-1: Front view
1. Floppy disk drive (old instruments only)

2. Function buttons
3. Graphic liquid crystal display (LCD)
4. Numerical keypad
5. Delete key
6. HELP key
7. START/OK button
8. Cursor moving buttons
9. Glowing LED
10. Sampling bar
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2.1.2 Rear Panel
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2.1.2-1: Rear view
1. Reagent tubing connections

2. External keyboard connector
3. Opening for air-flow rotor
4. Power input
5. 115/230 V selector
6. Small power switch for separating the instrument from the main power
7. Printer connector for external printer and USB port
8. Serial (RS 232) connector for computer
9. On/Off switch

2.2 Reagents
1. [DIL]: HC-Diluent Cat. No.: 17400/10 (20 litres)
Application: Diluent for automatic hematology analyzers HumaCount.
Required for: HGB, WBC measurements.
Components (active ingredients) Specification
Sodium chloride 2.5 g/l (0.25 %)
Inorganic phosphate buffer 5.6 g/l (0.56 %)
Sodium sulphate 10 g/l (1 %)
EDTA <1 g/l (<0.1 %)
Preservative <0.5 g/l (<0.05%)
2. [LYSE]: HC-Lyse CF Cat. No.: 17400/20 (1 litre)

Cyanide-free lyse reagent
Application: Lyse reagent for automatic hematology analyzers HumaCount.

Surfactants <0.5 g/l (<0.05 %)
Quaternary ammonium salt 35 g/l (3.5 %)
3. [CLEAN]: HC-Cleaner Cat. No.: 17400/30 (1 litre)

Cleaning solution
Used to clean the fluidics system.

Sodium phosphate 5 g/l (0.5 %)
Sodium sulphate 8 g/l (0.8 %)
Sodium chloride 3 g/l (0.3 %)
Preservative 1 g/l (0.1 %)
Proteolytic enzyme 8 g/l (0.8 %)
Sky blue 0.02 g/l (0.002 %)
Stability
The reagents are stable up to the expiry date on the label when stored at 15...35°C protected from light in a dark
place.
Once opened and installed on the instrument the reagents are stable for 60 days at 15...35°C. Instability due to
contamination is mostly indicated by cloudiness or colour change. This reagent should be replaced at once.
DO NOT FREEZE! Discard reagents once frozen.
Precautions and Notes
1. Leave the reagents at room temperature for at least 24 hours before use.
2. HUMAN reagents have been optimised for the HumaCount system. Use of and mix-up with third party
reagent have not been validated and may cause erroneous results.
3. [LYSE] contains quaternary ammonium salts which may cause irreversible effects to skin and eyes in case of
contact. Wear appropriate safety equipment (gloves and lab coat). In case of contact rinse immediately with
plenty of water. If swallowed, induce vomiting and seek medical advice.
4. [DIL] and [CLEAN] contain no hazardous substances in reportable quantities. In case of contact of skin or eye
rinse with water.
5. Specimens, controls and material coming into contact with them should be handled as potentially infectious
and must be disposed off in accordance with the applicable local regulations in force.
2.3 Fluidic Schematics

See Appendix “C”.
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2.4 Function of Fluidics
Sample flow prior to counting:
25 μl (50 μl in Prediluted mode) of anti-coagulated whole blood sample is aspirated by the sampling needle, and
4 ml of [DIL] is added into the chamber. 25 μl of primary dilution is aspirated and stored in the needle during the
WBC measurement. The necessary (preset) amount of lysing reagent is added to the primary dilution remaining in
the chamber. After the WBC measurement and a washing process, the instrument makes the second dilution into
the chamber with the sample stored in the needle and with 5 ml of [DIL] reagent.
Dilution rates:
1. Primary dilution: 1:160
2. RBC dilution: 1:32,000
3. WBC dilution: 1:196
Measurement times:
1. WBC counting: 8 seconds
2. HGB measurement: 3 seconds
3. RBC/PLT counting: 8 seconds
2.5 Control Panels
2.5.1 Sampling Bar

A push on the sampling bar triggers a measurement process.
2.5.2 Status LED

The status LED is located above the sampling bar (START button)
It has three colours indicating the actual status of the Fluidic System:
Color Analyzer status
• Green The analyzer is ready to work. New measurement can be initiated.
• Red The analyzer is performing a measurement process and no new measurement can be started.
• Yellow The analyzer is performing a maintenance process, or it is in stand-by.
2.5.3 Display
The display is a 240 x 128 dots, high contrast, CCFL backlit graphic LCD (Liquid Crystal Display) module.

2.5.4 Function key description
Function key Action triggered

Exit from menu or action
Leave data-entry menu without saving any changes made to it
Confirm the results or changes made
Display histograms of the highlighted patient ID or QC Lot No
Redo action (e.g. Blank measurement)
Modify sample/patient data
Send results to host computer
Print data (results, patient ID, QC)
Select between result pages (switch to PLT)
Select between result pages (switch to RBC, WBC)
PAGE-DOWN key in a multi-page menu
PAGE-UP key in a multi-page menu
Change the Levy-Jennings chart scaling (16 or 64 days)
Patient type selection

Patient type selection in a veterinary mode (dog/cat/horse/other)
Confirm error
Go to local menu (database, measurement)
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3 DESCRIPTION OF THE SOFTWARE
3.1 General
The integrated software controls instrument operations, displays, stores, recalls data, and allows the user to per-
form quality control (QC) and calibration procedures.
Pressing the START/OK button validates newly entered data, or activates/enters the highlighted item.
3.2 Menu System

The instrument uses a menu system to initiate actions, and to modify settings. In the menu system there are three
ways to navigate between menus and menu items.
− Position the selection bar to the desired item with the ↑ and ↓ buttons and press the START/OK button. This
will validate the highlighted menu item. Press the function key to return to the previous menu level. This
method is suggested while learning instrument operation.
− Pressing the number that corresponds to the desired menu item will also validate it. In this case there is no
need to press START/OK. Pressing the 0 (zero) button has the same effect as the function key. This
method is much more efficient in practice.
− You can move between the higher and lower menu levels by the ← and → keys.
The existence of a sub-menu is indicated by a ► symbol at the end of the menu line.
Some results can be displayed in table format. In this case the 3 (three) button has the same effect as the Page Up
key, and the 9 (nine) button has the same effect as the Page Down key. Use these buttons to move between table
pages. Further positioning keys during browsing the database are 1 (Jump to top) and 7 (Jump to bottom).
Some menu items have selected and deselected (on and off) states. These items are marked with a symbol in
front of the item number. The filled mark indicates selected state. Selecting the menu item toggles its state.
Other menu items work as so-called “radio-buttons”. It means that only one of the buttons of the group can be on
at once. In some cases, more buttons are displayed together, though they correspond to different groups. In this
case, a horizontal line separates the groups.

3.3 Menu Structure
Measure Measure Local Prediluted mode Cleaning

Database Measure blank Maintenance Priming
Maintenance Patient type Patient type Draining
Calibration Repeat last sample
Quality control Limits
Settings
Shut down View database Local Go to specified record Select by date time, and ID
Backup database Selection Select all
Restore and view Change sort order Deselect all
Backup selected records
Send selected records*** Unsorted
Delete selected records Sort by time
Sort by sample ID
Back up one day Sort by patient ID
Back up selected
Cleaning
Priming Prime all
Draining Prime [DIL]
Empty waste container Device information Prime [LYSE]
Diagnostics Statistics Prime [CLEAN]
Service Self test Human
Special human
Calibrate Calibrate MCV and MPV Veterinary
View calibrations Calibrate HCT and PCT
Calibration settings Factorial calibration
Calibration with one measure
Calibration with two measures
Calibration with three measures
Calibrate prediluted mode
Set QC reference QC level 1 Set date and time

QC measure QC level 2 Day.Month.Year
View table of QC measures QC level 3 Month.Day.Year
View QC diagram QC level 4 Year.Month.Day
Set QC level QC level 5
QC level 6 Human
Male
Date and time Female Cat
Laboratory Baby Dog
Units Toddler Horse
Limits Child Other1
Fluid sensors [DIL] Veterinary limits ** Other2
Printer settings [LYSE] Other3
User settings Waste Other4
Other5
Shut down Single-user mode
Logout * Multi-user mode
Prepare for shipment Add new user *
* if multi-user mode is enabled

** if vet option is available
*** if serial communication is enabled
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4 OPERATING PRINCIPLES
4.1 Impedance Method
Internal electrode
+ Aperture
Blood cell suspension
External electrode
The impedance method counts and sizes cells by detecting and measuring changes in electrical impedance when a
particle in a conductive liquid passes through a small aperture.
Each cell, passing through the aperture – where a constant DC current flows between the external and internal
electrodes – causes some change in the impedance of the conductive blood cell suspension. These changes are
recorded as increases in the voltage between the electrodes.
The number of pulses correlates to the number of particles (CBC - Counting Blood Cell). The intensity of each pulse
is proportional to the volume of that particle (WBC, RBC, PLT histograms). Pulses are counted only in channels (in
terms of femtoliters, fl) which are between the pre-set lower and upper discriminators.
4.2 Principle of the HGB Measurement

The lysed 1:196 sample dilution can be measured by a cyanmethemoglobin method. The reagent lyses the red
blood cells, which release hemoglobin.
Hemoglobin iron is converted from the ferrous (Fe2+) to the ferric (Fe3+) state to form methemoglobin, which com-
bines with potassium cyanide (KCN) to produce the stable cyanmethemoglobin, or hemoglobincyanide. Subse-
quently, the HGB concentration is measured photometrical.
Note: The above-mentioned measuring method is used to determine the HGB concentration. The HGB concentra-
tion can be measured using cyan-free lysing reagents as well. In this case the effect is the same but the used lyse is
environmental-friendly reagent.

4.3 Parameters
White Blood Cell – WBC Number of leucocytes
(cells/l, cells/μl) WBC = WBCcal (cells/l, cells/μl)
Red Blood Cells – RBC Number of erythrocytes
(cells/l, cells/μl) RBC = RBCcal x (cells/l, cells/μl)
Hemoglobin concentration – HGB Measured photometrical 540 nm; in each cycle blank meas-
(g/dl, g/l, mmol/l) urement is performed on [DIL]
HGB = HGBcal x (HGBmeasured – HGBblank)
Mean Corpuscular Volume – MCV Average volume of individual erythrocytes derived from the
(fl) RBC histogram
Hematocrit – HCT Calculated from the RBC and MCV values.
(percentage, absolute) HCTpercentage = RBC x MCV x 100,
HCTabsolute = RBC x MCV
Mean Corpuscular Hemoglobin – MCH Average hemoglobin content of erythrocytes, calculated from
(pg, fmol) RBC and HGB values.
MCH = HGB/RBC
Mean Corpuscular Hemoglobin Concentration – Calculated from the HBG and HCT values.
MCHC MCHC = HGB/HCTabsolute
(g/dl, g/l, mmol/l) Unit of measurement is displayed according to the one cho-
sen for HGB result (g/dl, g/l, mmol/l)
Red Cell Distribut. Width – RDW-SD The distribution width of the erythrocyte or platelet popula-
And tion derived from the histogram at 20% of peak
Platelet Distribut. Width PDW-SD
(fl)
Red Cell Distribut. Width – RDW-CV
And
Platelet Distribut. Width – PDW-CV
(absolute)
xDW-SD = RDWcal x (P2 – P1) (fl),
xDW-CV = RDWcal x 0.56 x (P2-P1) / (P2 + P1)
by the factor of 0.56 CV is corrected to the 60% cut
Platelet – PLT Number of thrombocytes (platelets)
(cells/l, cells/μl) PLT = PLTcal x (cells/l, cells/μl)
Mean Platelet Volume – MPV Average volume of individual platelets derived from the PLT
(fl) histogram.
Thrombocrit – PCT Calculated from the PLT and MPV values.
(percentage, absolute) PCTpercentage = PLT x MPV x 100,
PCTabsolute = PLT x MPV
White blood cell differential: Absolute values counted in the channels determined by the
1. LYM, LY% : lymphocytes three WBC discriminators:
2. MID, MID% : monocytes and some eosinophil 1.
granulocytes LYM MID GRA
3. GRA, GR% : neutrophil, eosinophil and
basophile granulocytes
1.: RBC LYM discriminator

2.: LYM-MID discriminator
3.: MID.GRA discriminator
Percentages calculated from the absolute WBC value.
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4.4 Absolute and Linearity Ranges of Measured Parameters
Within the linearity range, the instrument works according to the specified accuracy. Outside this linearity range,
the system will display the results, but without the specified accuracy.
If the value is over the maximum range, the instrument cannot measure it and the result is marked with an E
(Error) flag. In this case, pre-dilution of the sample is recommended (e.g. very high WBC). For pre-diluted mode, see
section 7.1.5 of this manual.
Linearity ranges of primary parameters in normal measuring mode:
Parameter Linearity Ranges Maximum Unit

WBC 0...75 100 109 cells/litre
RBC 0...15 20 1012 cells/litre
PLT 0...700 1000 109 cells/litre
HGB 0...250 400 g/l
HCT 0...100 - %
MCV 30...150 - fl
MPV 3...30 - fl
The linearity ranges for 1:3 pre-diluted mode:

Parameter Linearity Ranges Maximum Unit
WBC 4...300 400 109 cells/litre
RBC 2...40 60 1012 cells/litre
PLT 200...3000 4000 109 cells/litre

5 ANALYZER INSTALLATION PROCEDURES
5.1 Unpacking
Only trained Service Personnel should perform unpacking. It is recommended to carefully inspect for any damage
or missing items at the time of unpacking.
CAUTION! Before the first operation, let the instrument warm up to room temperature for at least 6 hours; other-
wise the temperature gradient could cause water condensation, which may damage the electronic parts.
5.2 Connecting Reagent Containers

All containers should be left open to provide free airflow.
5.3 Connecting Power Cord

Connect the power cord to the connector located on the rear panel and then to a grounded electrical outlet.
Do not, for any reason, power the instrument from an electrical outlet that is not properly grounded.
5.4 Connecting an External Printer
Connect external printer to the parallel port located on the rear panel. A built-in parallel interface protocol is pro-
vided for Epson 9-pin or compatible, Epson 24-pin or compatible, and for HP PCL4 compatible printers. (For printer
settings see 6.7.)
5.5 Connecting the Instrument to a Host Computer

The instrument has a built-in serial communication protocol that allows connecting the analyzer to a host com-
puter. This serial interface is able to send results (including histograms) to the host computer. The serial I/O set-
tings are in the service menu system. Therefore if you want to connect your instrument to a host computer, please
call your Service Person.
5.6 Turning the Instrument ON

1. Turn on the connected external printer
2. Turn on the power supply of the instrument by flipping the small power switch to I position.
3. Press the large switch located on the left side of the rear panel to power up the instrument.
An automatic start-up procedure will be initiated.
During the start-up, the following screen is displayed.
The software version number appears in the bottom
line when the program is started.
Main menu
When the start-up procedure is completed, the MAIN
1.Measure ? MENU is displayed.
2.Database ? Sub-menus are indicated with an ► arrow in the end
3.Maintenance ?
4.Calibration ? of the line. In this case, you can use → key to enter the
5.Quality control ? selected sub-menu.
6.Settings ?
7.Exit ?
CAUTION!
Wait 5 minutes before starting any measuring process. This time is required to reach the optimal working tem-
perature.
5.7 Display Contrast Setting

From the Main menu go to Maintenance menu. After selecting Service submenu, you can adjust the display con-
trast (visibility / brightness). Up arrow (↑) lightens, down arrow (↓) darkens the screen.
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5.8 Reagent Priming
In some cases, a priming cycle must be performed. The instrument will perform the cycle automatically if the fluid
sensors are on, and the instrument detects that there is not enough liquid in the tubing system. Priming cycle
should be run in the following cases:
− At installation
− In case of extended time out of use
− After any component replacement related to the Fluidic System
5.9 Turning the Instrument OFF
Exit EXIT (7)

1. Shut down (SHUT DOWN (1))
2.Preparing for shipment
The analyzer should not be switched off by simply
unplugging it. For shutdown, always use EXIT menu
(7), item 1.
The software will prompt you for confirmation. Press 1 and the analyzer will perform a priming cycle to fill the
chamber to avoid dust and salt build-up, and shuts itself down.
The second item should be used when the instrument is to be shipped. In this case, the instrument will ask you to
connect the cleaning tube kit with 100ml of distilled water. Follow the instructions appearing on the display.
! Message 5001/19300
EXIT (7)
Remove reagent tubing at rear reagent inputs PREPARING FOR SHIPMENT (2)
(Diluent, Lyse and Cleaner) Here, the instrument asks you to remove tubing
connectors, so that they can be drained. Leave waste
connector on.
! Message 5002/19300 Next, you should connect at least 100 ml of distilled

Connect min 100 ml distilled water to reagent water, which the instrument uses to wash out any
inputs using cleaning tube kit. reagents remaining in the system. Waste must still be
on.
! Message 5003/19300
Next, the analyzer asks you to remove cleaning tube
Remove cleaning tube kit. Keep reagent inputs kit (waste must still be on).
free.
When finished, the analyzer will ask you to power off
the system.

6 SOFTWARE SETTINGS
6.1 Customize
This option shows possible adjustments to operation,
and result display.
6.1.1 General Settings

General settings allow selection of operating language,
and serial communication options. Serial
communication speed and protocol can be determined.
Consult your Service Staff for information, and
adjustment options. If no host computer and necessary
communication software is connected, and you apply
the settings, the instrument will try to connect through
serial link. It may take up to 20 seconds – you will see a
progress bar running in the bottom of the screen – it is
normal. If the instrument fails to find the host
computer, then it will disable communication. (You can
re-enable it later any time)
Enable diagnostic flags

This will enable diagnostic Flags service, which offers primary diagnostics for results. This analyzes test results, and
depending on some conditions, displays some messages attached to the results (see Section 7.1.5).
Settings The SETTINGS sub-menu allows you to set customer-

1.Date and time ? defined limits, hardware and software configurations
2.Laboratory
3.Units required for proper instrument operation.
4.Limits ? From this sub-menu, you can access the date and time,
5.Fluid sensors ?
6.Printer settings limits, patient type, and other settings related to the
7.User settings ? instrument.
6.2 Setting Date and Time

The date and time of each measurement is stored with the results. This menu allows setting the built-in clock of
the instrument and date format.
Date and time SETTINGS (6)
1.Set date and time DATE AND TIME (1)
? 2.Day.Month.Year
? 3.M onth.Day.Year
By selecting item 1, you will enter date and time setting
? 4.Year.Month.Day mode (next screen).
Items 2-4 are radio-buttons, so only one can be selected
at once.
Set date and time SETTINGS (6)

DATE AND TIME (1)
The current date and time are SET DATE AND TIME (1)
12.05.2003 15:00 Enter the actual date and time using the numerical
keypad. The date is displayed as it was set in the
previous menu.
Confirm by pressing the button.
17/44
6.3 Setting the Name of the Laboratory
This menu allows entering laboratory information, which will be printed in the header of reports generated by the
instrument.
Set laboratory name
SETTINGS (1)
The name of the laboratory is: LABORATORY (2)
Hematology-1 A maximum of 40 characters can be entered in each
line of four either using an external standard PC (US-
This name will be printed in the header layout) keyboard connected to the instrument, or by
of the printouts scrolling each letter character using the ↑ and ↓
buttons.
Move between character places using ←and → keys.
6.4 Results Units Setting
Units SETTINGS (6)

UNITS (3)
Count unit cells/l ? Units can be set in a sequential order. The arrow on the
HGB unit g/l
PCT, HCT unit % right indicates that there are more options for the
RDW, PDW mode sd entry. Select among them using the ↑ and ↓ buttons.
When done, pressing OK opens the next unit type for
setting. When the last entry is set, confirms data, and
returns to the Settings menu.
The possible units for above parameters are as follows:

Count unit cells/litre, cells/μl
HGB unit grams/litre (g/l), grams/decilitre (g/dl), millimols/litre (mmol/l)
PCT, HCT unit percentage (%), absolute (abs)
RDW, PDW mode Standard Deviation (sd), Coefficient of Variation (cv)
6.5 Setting Reference Limits

This function allows the User to specify the patient reference (so-called normal) ranges used in your laboratory.
Lower and upper limits - stored in the memory - are displayed and can be modified according to the patient type
selected in the PATIENT TYPE menu.
Limits
SETTINGS (6)
1.Human LIMITS (4)
2.Male
3.Female
4.Baby In this menu, you can set the limits of the different
5.Toddler patient types.
6.Child
7.Vetrinary limits
The next three figures show the reference range settings of Female patient type.
SETTINGS (6)
Patient limits
Female LIMITS (4)
Lyse 0.90 ml FEMALE (3)
WBC 5.0 - 10.0 10^9/l
RBC 4.00 - 5.00 10^12/l Modify the highlighted lower and upper limits with the
HGB 120 - 160 g/l numerical keypad. Confirm with OK.
HCT 36.0 - 48.0 %
MCV 76 - 96 fl
MCH 27.0 - 32.0 pg

Patient limits By pressing and function key buttons, you
MCHC 300 - 350 g/l can turn to other pages with additional parameters.
PLT 150 - 400 10^9/l
PCT 0.0 - 0.0 %
MPV 8.0 - 15.0 fl
PDWs 0.0 - 0.0 fl
PDWc 0.0 - 0.0 %
RDWs 20.0 - 42.0 fl
RDWc 0.0 - 0.0 %
If 0.0 - 0.0 is specified as lower and upper limit, the parameter will not be checked for its proper range.
Patient limits
Actual [LYSE] quantity can be modified before each
LYM 1.3 - 4.0 10^9/l measurement by ± 0.2 ml step (see 7.1.7).
MID 0.2 - 0.7 10^9/l
GRA 2.5 - 7.5 10^9/l
In the same submenu the software also allows the user
LY% 25.0 - 40.0 % to set the different veterinary normal ranges and the
MI% 3.0 - 7.0 % quantity of the added [LYSE] .
GR% 50.0 - 75.0 %
Limits SETTINGS (6)

1.Dog LIMITS (4)
2.Cat VETERINARY LIMITS (7)
3.Horse
4.Other1 Other 1…5 submenus let the user to set any kind of
5.Other2 animal type, name, limits and [LYSE] quantity. The next
6.Other3
7.Other4 three figures show the reference ranges settings of
8.Other5 veterinary patient type.
Patient limits Patient limits

MCHC 310 - 340 g/l Dog
PLT 200 - 500 10^9/l Lyse 0.60 ml
PCT 0.0 - 0.0 % WBC 6.0 - 17.0 10^9/l
MPV 0.0 - 0.0 fl RBC 5.50 - 8.50 10^12/l
PDWs 0.0 - 0.0 fl HGB 120 - 180 g/l
PDWc 0.0 - 0.0 % HCT 37.0 - 55.0 %
RDWs 0.0 - 0.0 fl MCV 60 - 77 fl
RDWc 0.0 - 0.0 % MCH 19.5 - 24.5 pg
Patient limits SETTINGS (6)

LYM 1.0 - 4.8 10^9/l LIMITS (4)
MID 3.0 - 12.0 10^9/l DOG (1)
GRA 0.1 - 1.3 10^9/l
LY% 12.0 - 20.0 % Modify the highlighted lower and upper limits using
MI% 3.0 - 10.0 % the numerical keypad. Confirm with OK.
GR% 62.0 - 87.0 %
By pressing and function keys, you can
move to other pages with additional parameters.
If 0.0 - 0.0 is specified as lower and upper limit, the parameter will not be checked for its proper range. Actual
[LYSE] quantity can be modified before each measurement by ± 0.2 ml step (see 7.1.7).
19/44
6.6 Fluid Sensors
Fluid sensors check for presence of the most important reagents: [DIL] , [CLEAN] and [LYSE] .
If any of the fluid sensors get out of order, the analyzer can still continue operating, if the malfunctioning sensor is
manually disabled.
Fluid sensors SETTINGS (6)

? 1. Diluent & Cleaner FLUID SENSORS (5)
¦ 2. Lyse
¦ 3. Waste Any sensor can be switched on and off by toggling its
state using the OK button.
Here, [DIL] & [CLEAN] sensor is disabled.
If any of the fluid sensors is switched off, an S warning

can be seen in the top-left corner of the screen during
measurement.
There is a software counter method for waste full checking. The Service Personnel must set the waste container
capacity during installation. The instrument counts the drained waste volume and gives a warning message when
it reaches the set waste container capacity.
The User can reset the waste counter in the MAINTENANCE (3) / EMPTY WASTE CONTAINER (4) sub-menu.
This is strongly recommended to use this method with the following rules:
− Always use the same or higher capacity waste tank that was set during installation. If you want to change
waste tank size, please call your Service Person.
− Empty waste tank when the instrument gives you the warning: “waste is full”.
− If you replace waste tank do not forget to reset the software waste counter.
6.7 Printer Settings

The instrument supports the following printers or printer modes:
− HP DeskJet
− HP LaserJet
− Epson 9-pin
− Epson 24-pin
− Epson 24-pin in 9-pin mode
− Canon BJC
− Seiko DPU414
Any printer being able to emulate any of the above modes can be connected to the instrument.
To set up the instrument for your printer, go to the “Settings/Printer Settings” menu. Choose one of the
possibilities using the up and down arrow keys within the text fields, and fill in the numerical fields using the
numerical keys.

The general characteristics of the printable area of printer paper are below:
Paper width The paper is defined by its size:
it can be standard (A4, Letter) or any other
Physical margins custom size paper (actual size).
Top margin
Printers cannot print on the whole surface of
Result
Left margin
the paper. The blank area is described by the

Printable area
physical Margins, which may vary by printer
models. The paper area inside the physical
Vertical spacing margins is called printable area.
Top margin and Left margin settings are used
Result for determining the exact place where the
results inside the printable area are printed.
Paper height
If more than one result is to be printed on one sheet of paper, use Vertical spacing to determine the distance
between the reports.
Printer settings
On the first page of Printer Settings, printer type,
Printer: graphics mode and paper settings can be set.
Seiko DPU414 Select the Printer matching your printer hardware.
Mode:
Normal Wide ? Different Modes result in different printout sizes.
Physical margin: Normal Choose the one matching your needs. The available
Paper: A4 modes depend on the selected printer type. Possible
Unit: inch
Size 8.27 x 11.69 options are: Mini, Small, Normal, Enhanced and Large
for the size, Wide and Narrow for the width and the
optionally Fast mode. Recommended mode is Normal.
Physical Margin is used to correct the printout for a printer having lower printable area. Bigger margin means
bigger physical margin. Alter the ‘normal’ setting only, if the right side of the printed result is missing, or appears in
the next line.
Select Paper, or enter correct Size parameters: either in inches or in cm, specified at Unit.
The second page of printer settings enables changing further margins, vertical spacing of reports, and other
options.
Printer settings If roll paper is used instead of sheets, set Rollpaper to

Margins: Yes.
Left: 0.00 Top: 0.00 If all results are to be printed automatically after each
Vertical spacing: 0.50
Rollpaper: No measurement, set Autoprint to Yes.
Autoprint: No Printout format can be specified as one of the
Printout format: Full with histograms
Table format: Normal table format
following:
One result per page: No − Full with histograms
− Text only
− Short, text only
If you set One result per page to Yes, each measurement will be printed on another page.
Printer settings
The third page of printer settings holds the options for
Print ranges: Yes the individual result-printing.
Print flags: Yes If Print Ranges is set to Yes, the upper and lower limits
Print warning flags: No
(if specified in Settings/Limits) will be printed next to
each measured parameter for verification.
21/44
If Print Flags is set to Yes, and any measured value is out of the normal range, or there was any error, those will be
shown on the printout as well. It is recommended to set it to Yes.
If Print warning flags is enabled, any flags that was shown on the result screen will be included with the printout.
6.7.1 Troubleshooting Guide for Printing Problems

Problem Possible reason, remedy
Printer does not respond, no printout. − Printer is off. Turn it on.
− Printer is not connected to the analyzer.
− Connect it to the parallel port at rear.
− Printer is not On-line. Switch it to On-line mode.
Printer is out of paper. Feed the printer with paper.
Strange signs or letters appear on the printout. − The selected printer type does not match your
printer. Select the appropriate type in Printer
Settings menu.
− Printer is not set up properly for HP or Epson (or
compatible) mode. Modify the printer setup.
Consult the printer’s manual
Right side of the printed report is missing, or appears in − Decrease Margin settings in the Printer Settings
the next line. menu.
− Try selecting another Mode making a smaller
printout.
The printed report is too small; there is a lot of space on − Try selecting another Mode resulting in larger
the paper. printout.
The end of the printout appears on the next page. − Enter the correct Paper size.
− Try increasing Margin.
It seems that one more patient report could fit on the − Enter the correct Paper size.
same page. − Try decreasing Margin, Top margin, Vertical
spacing.
The printed result is not centred horizontally. − Modify Left margin.
The printed result is not centred vertically. − Modify Top margin.
The distance between two results is too small or too − Modify Vertical spacing.
big.
After printing, the printer does not eject the paper. But − It is quite usual for bubble-jet or laser printers.
if you repeat printing, it appears in more copies. Do not repeat printing.
When the page is full, or you leave the actual menu,
the printer will eject the paper automatically.
6.8 User Settings
User settings SETTINGS (6)

? 1.Single user mode USER SETTINGS (7)
? 2.Multi user mode This menu allows configuring the instrument for
single-user or multi-user mode.
Care must be taken when changing to multi-user
mode.
User settings
SETTINGS (6)
? 1.Single user mode USER SETTINGS (7)
? 2.Multi user mode MULTI USER MODE (2)
3.Add new user
By selecting item 2, the instrument enters multi-user
mode, and a new item appears on the screen: Add new
user.

Multi-user mode allows more people using the same instrument with individual personal settings, so-called
profiles.
In a multi-user environment users have their own profiles describing their rights within the system. In an
environment like this there must be a so-called supervisor having the right to add, delete users and modify their
rights.
The software of the instrument has three levels of user-rights: Basic, Advanced and Supervisor.
A Basic-level user has absolutely minimal rights within the system. They can perform measurements and entering
patient data before the measurement.
An Advanced-level user has the rights to modify settings of the instrument: as described in chapters 6., do QC and
Calibration. An Advanced user can also modify patient data when browsing in the database.
A Supervisor has the ability to do all the above, and additionally to modify user rights and user passwords.
In Multi-user mode, there must always be a user with Supervisor rights, otherwise only a Service-person can reset
the instrument.
User information
SETTINGS (6)
User ID 1 USER SETTINGS (7)
Name ADD NEW USER (3)
Frank Smith____________________
Level Basic To each new user, the software assigns an individual ID.
Active Yes In the next field, a user name of 32 characters can be
Password
specified.
When the name is entered, the level should be defined. The default setting for Active is Yes. Use this option if you
want to disable a user.
The last data to enter is the password, a maximum of 8 alphanumeric characters.
6.8.1 Multi-user Mode

If the analyzer is in multi-user mode, a logon screen will
Login
User ID 0________ be displayed during start-up, asking for a User ID and a
Password password.
User name
When the User ID is entered (confirm with OK), the user

Login
User ID 1 name corresponding to the ID appears in the lower line.
Password ****_____ If the user name was correct, enter the password, and
User name confirm with the function key. If the password was
Frank Smith
correct, the analyzer continues initialisation and is
ready to work.
In multi-user mode the Exit menu is changed: a Log-out menu point appears.
Exit
EXIT (7)
1. Shut down When the user logged in has finished working with the
2. Preparing for shipment instrument, it is not necessary to switch off. From the
3. Logout
main menu, selecting EXIT (7) brings up the EXIT menu.
LOGOUT should be used instead of shutdown, as in this
case the log-in screen will be displayed waiting for the
next user to log in
23/44
7 ROUTINE UTILISATION
7.1 Measuring Process
7.1.1 Sampling
The aspirating tip (a needle with rounded end) is used to draw sample from the tube containing the blood to be
analyzed. It cannot always be seen, as it has two positions:
− Retracted position: inside the instrument (the status LED is either red, yellow or off).
− Aspirating position: in front of the sampling bar; it can be activated only in certain menus associated directly
with the sampling process; status LED is green.
− Invert the closed sample tube 11 times to achieve a homogenous sample. Do not shake!
− Take off the cap of the sample tube.
− Immerse the aspiration needle well into the sample.
− Push the sampling bar or the START/OK button.
The instrument draws 25 μl of sample, and the aspirating needle is retracted while its outer surface is
automatically rinsed with [DIL]. This ensures a low carry-over between samples. Simultaneously, the status LED
turns red.
During aspiration, hold the sampling tube in a stable position (for approx. 1 second) until you see the status LED
flashing and hear the beeps indicating the end of the sampling process.
After these signals, you can remove and recap the sampling tube.
Make sure to immerse the sampling needle well into the sample, otherwise it can cause erroneous sampling,
giving inaccurate results.
Important!
When the needle stops for a while during its movement upwards, the needle must be out of the sample, otherwise
the analyzer makes another aspiration in this state. This extra aspiration can also cause an inaccurate
measurement.
7.1.2 Blank Measurement

Blank measurement is used for checking the cleanliness of the system and reagents.
Blank measurement must be performed in the following cases:
− Once daily, before the sample analyses (this is done automatically before the first measurement in MEASURE).
− After any reagent change (it can be activated manually from the MEASURE/ MEASURE BLANK menu).
− After any component replacement, which is closely related to a measuring process (aspiration, dilution,
counting, rinsing).
User must accept the blank values by pressing .
Blank measurement can be repeated by pressing
.
If any of the tested parameters has High blank value,
the message: Unsuccessful blank measure appears at
the top of the screen.
There are 3 regions for blank value handling:

− Optimal, all results are OK.
− Blank is high, * flag is displayed at related parameter results.
− Blank is too high, no result displayed in measurement mode.
Blank measurement ranges:
Parameter 1. No flag at parameter 2. * flag at result 3. E (error) flag at result
HGB 0 -10 g/l 10 - 25 g/l > 25 g/l
WBC 0 - 0.5 x103 cells/μl 0.5 - 1.0 x 103 cells /μl > 1.0 x 103 cells /μl
PLT 0 - 25 x103 cells /μl 25 - 50 x 103 cells /μl > 50 x 103 cells /μl
RBC 0-0.05 x106 cells/μl 0.05 - 0.5 x 106 cells /μl > 0.5 x 106 cells /μl
Accepted blank values are essential for proper calibration and QC measurement. For this reason, no calibration or
QC measurement can be performed without accepted blank values.
Quality control (QC) measurement and Calibration can be performed only if all blank values are in the 1st region.

7.1.3 Calibration
Calibration is the procedure used to standardize the instrument by applying the necessary correction factors.
Preferred hematology control is 17400/40 HC-Control Low, Normal and High.
It is recommended to do calibration in the following cases:
1. At analyzer installation, before beginning the analyses.
2. After replacing any component, related to the process of dilution or measurement.
3. When quality control measurements show any systematic error (bias) or they are outside predefined limits.
4. At regular time intervals (determined by the lab itself).
5. If you want to use the instrument in Prediluted mode.
Calibration can be performed in two ways:
1. User can enter calibration factors - without any calibration measurements – using the numerical keypad.
2. One-, two- or three-fold measurements of control or special calibrations material with known parameters. In
this case, the instrument automatically calculates new factors using the following formula:
Assigned value x Stored factor

New factor =
Measured value(s) (or average of those)
CAUTION!
New calibration will invalidate the previous one. Old values cannot be retrieved, but can be reviewed in the VIEW
CALIBRATIONS menu.
Calibration can be initiated by choosing Calibration in the Main Menu.
Calibration CALIBRATION (4)

1.Calibrate Item 1 initiates calibration procedure.
2.View calibrations Item 2 displays previous Calibrations
3.Calibration settings
Item 3 opens calibration settings dialogue.
7.1.3.1 Factorial calibration

If the CALIBRATION MODE has been previously set to Factorial Calibration, the factors can be set manually in the
0.80 - 1.20 range.

RBC 1.02 CALIBRATE (1) (factorial)
MCV 1.05
RDWc 1.12 Set previously calculated factors using the numeric
PLT 1.00 keys, confirm with OK.
MPV 1.00
HGB 0.92 Only parameters concerning the selected MCV, MPV /
WBC 1.01 HCT, PCT mode are displayed.
7.1.3.2 Automatic calibration by measurement

If the CALIBRATION MODE is set to one-, two- or three-fold measurements, the instrument will perform calibration
measurements with hematology blood control.

RBC 4.57 10^12/l CALIBRATE (1) (automatic)
MCV 85 fl Set the target values of the control material using
RDWc 16.4 %
PLT 255 10^9/l numeric keys. Use OK to accept a value.
MPV 9.1 fl Specify 0 as target value for parameters should be
HGB 136 g/l
WBC 7.4 10^9/l omitted from calibration.
After setting the target values, press to validate and start calibration measurements.
25/44
Target values for the calibrated parameters can be set in the following ranges:
Parameter Low limit High limit
RBC 1.00 8.00
HCT 0.1 0.6
MCV 50 120
RDW CV 10 50
PLT 30 800
PCT 0 2
MPV 5 15
PDW CV 5 50
HGB g/l 30 300
WBC 1.0 30.0
Having set the required target values, perform

measurements on hematology blood control, hold the
sample tube in sampling position and press the
sampling bar.
Press to accept results.
The actual and the total number of calibration
measurements are shown in the first line.
Calibration After calibration the new factors are displayed. The

RBC 1.02 (1.03) actual factors are shown in parentheses for reference.
MCV 1.05 (1.01) Offered calibration factors can be accepted by pressing
RDWc 1.12 (1.09)
PLT 1.00 (0.92) .
MPV 0.98 (0.96)
HGB 1.08 (1.05) The factors are not modified, but get flagged:
WBC 1.15 (1.11) − if 0 was targeted (no calibration)
B if blank was not in the 1st region
E if factor is out of 0.80-1.20 range
7.1.3.3 View calibrations

From the Calibration menu, you can monitor previous calibrations. The instrument logs all calibration events, and
displays them in the following format.
Date Time OpID RBC MCV RDWc PLT CALIBRATION (4)

23.05.2003 10:15 0 1.03 1.07 0.85 1.04 VIEW CALIBRATIONS (2)
29.05.2003 11:21 0 1.01 1.07 0.86 1.01 Use ← and → keys to browse between parameter
02.06.2003 09:51 5184 1.00 1.00 1.00 1.00
columns.
Exit pressing function key with symbol.
7.1.3.4 Calibration settings

By choosing CALIBRATION SETTINGS, you get to the following screen:
Calibration settings CALIBRATION (4)

? 1.Calibrate MCV and MPV CALIBRATION SETTINGS (3)
? 2.Calibrate HCT and PCT
? 3.Factorial calibration
? 4.Calibrate with one measurement
Items 1-2 select between calibration target,
? 5.Calibrate with two measurements Items 3-6 select between calibration modes.
? 6.Calibrate with three measurements
? 7.Calibrate prediluted mode Select item 7 to perform CALIBRATION FOR PREDILUTED
MODE. By choosing this point, you can calibrate the
instrument with the same processes (factorial,
automatic) as in normal mode.

When Calibrate prediluted mode is selected, Calibration/Prediluted mode will appear at the first line on the
Calibration screens.
The previous Prediluted calibration factors cannot be monitored in the VIEW CALIBRATIONS submenu.
To perform factorial calibration, you should set target parameter (1 or 2), and choose item 3, Factorial Calibration.
In this case, User must have had the necessary amount of measurements with the control material, based on
which an average value can be calculated. This average value is used for fine-tuning the calibration parameters.
7.1.4 Sample Analysis
7.1.4.1 Sample preparation

Use fresh whole blood, anti-coagulated with K3-EDTA as sample. Prior to sampling, mix the sample gently by
inverting it 11 times. Do not shake as this could damage the blood cells.
7.1.4.2 Sample information

The instrument allows the User to enter sample information for each sample that has been, or will be measured.
An external PC keyboard (standard USA layout) must be connected to the instrument before turning it on.
Sample information can be entered in two ways:
− immediately before measurement, or
− in the Database menu
Sample information To enter sample information before sample analysis,

Sample ID: 1 press the function key. This brings up the
Date: 2003.05.12.
Patient ID:
following screen:
Name: Here sample ID and patient data can be specified
Roland Heyer
Birth. 1958.04.16. Male (name, sex, date of birth). Also, the name of the doctor
Doctor: dr. Hans B. Kern having ordered the laboratory analysis can be given.
Patient name will appear on the LCD below the PLT
histogram (second page), and in the header of the
printed results sheet.
Sample information On this screen, the patient age can be entered in years
Sample ID: 1 or in months depending on your selection.
Date: 2003.05.12.
Patient ID: As the requirements vary from lab to lab and is strictly
Name: related to regular laboratory work, the user cannot
Roland Heyer change this option. Contact service for further
Age: 25 years ? Male
Doctor: dr. Hans B. Kern information.
Type in the name using up to 32 alphanumeric characters, (“A-Z”, “0-9”, space, comma, dot and parentheses “()”).
Use arrow keys to move between characters, backspace to delete missed characters.
Press Enter after entering the name, cancel with Esc or , confirm with .
7.1.4.3 Results
At the end of a measuring procedure, the following screen is displayed, including all measured and calculated
parameters as well as the WBC, RBC and PLT histograms.
Results and histograms will be stored automatically in
the memory, without any operator confirmation. (First
panel of two)
If normal ranges are set (not 0.0), parameters will be
verified and marked by:
+ if the value is over,
- if the value is under the range specified.
− If there is any kind of error, or the blank measurement is too high, E error flag will appear at the erroneous
parameter and no results will be displayed (---).
− If there are warnings or errors, a ∗ flag will appear preceding the actual result.
27/44
In the last line of the first result screen, warning flags can be displayed. If the last line is clear, it means that no
errors or warnings were found during measuring cycle. The meaning of each warning flag and the recommended
user action is included in the next table.
Flag Meaning Recommended user action
W WBC three part warning − Repeat the measurement. Possibly [LYSE] problem.
or WBC three part diff. − Check the discriminators in the WBC histogram. If the discriminators are
unsuccessful in the proper place (the populations can be separated visually) then the
results can be accepted.
E No WBC three part − Possibly [LYSE] problem, but in some pathological samples (too high
lymphocytes), it can be happened.
H HGB blank is high, or no − Repeat the blank measurement and accept it.
HGB blank − Possibly [LYSE] or [DIL] problem.
B WBC blank is high, or no − Repeat the blank measurement and accept it.
WBC blank − Possibly [LYSE] or [DIL] problem.
L WBC/RBC limit warning − Check the 1. RBC-LYM discriminator. If it is in the minimum point (or close
to it), accept the results. Otherwise repeat the measurement.
− If the rerun gives very similar results and the discriminator is in a wrong
place then the MID and GRA results are OK, but the WBC and LYM results
can be higher because of the RBCs.
R Too many RBC cut from − Repeat the measurement. Possibly [LYSE] problem.
WBC − If the WBC measuring time is too high (more than 8 sec.) it could be
aperture clogging. In that case perform cleaning and repeat the
measurement.
M* WBC coincidence is too − The results are out of the linearity range. Make a dilution with an external
high. Linearity error. dilutor with a pre-defined dilution range. Do not forget to correct the
results with the defined factor.
D WBC data package errors − Perform cleaning and repeat the measurement (aperture clogging).
− If it is a general problem, please call your Service Personnel.
S WBC time error − The same action as in case of the D warning flag.
C WBC clogging − Aperture clogging. The same action as in case of the D warning flag.
p PLT blank is high, or no − Repeat the blank measurement and accept it.
PLT blank − [DIL] problem. Replace [DIL] , open a new tank.
b RBC blank is high, or no − Repeat the blank measurement and accept it.
RBC blank − [DIL] problem. Replace [DIL] , open a new tank.
l RBC/PLT limit warning − The RBC/PLT valley is too high. It is rather a diagnostic flag. If the
discriminator is in a wrong place (in the PLT or RBC histogram) then
repeat the measurement for a correct PLT result.
k RBC peak warning − Perform cleaning and repeat the measurement (clogging).
− If it is a general problem, change the RBC aperture.
m* RBC/PLT coincidence is − The same action as in case of the M warning flag.
too high. Linearity error.
d RBC/PLT data package − The same action as in case of the D warning flag.
errors
s RBC/PLT time error − The same action as in case of the D warning flag.
c RBC/PLT clogging − The same action as in case of the C warning flag.
*M or m warning flag means that the coincidence is too high so the results are out of the linearity range - see
Section 4.4. In that case, make a predilution with an external dilutor and use the Prediluted mode (see section
7.1.6).
7.1.5 Diagnostic flags

The instrument offers basic diagnostic hints for the operator. These flags are showing messages usually paired
with some parameters measured outside the normal range.
The flags will only appear on a printed report. The flags are grouped together below the parameter group (external
printer).

Possible displayed diagnostic flags :
LOW Parameter HIGH
Leukopenia WBC Leukocytosis
Granulopenia GRA Granulocytosis
Lymphopenia LYM Lymphocytosis
RBC Erythrocytosis
HGB Anemia
Microcytosis MCV Macrocytosis
RDW Anisocytosis
Hypochromia MCHC
Thrombocytopenia PLT Thrombocytosis
MPV Macro PLT
Below is an example of the diagnostic flags in printed form:
In the next figure, one of the long-format printout patient results with histograms is shown.
The HumaCount 07.03.2003 15:38 #2 Female
At the bottom of the screen,
warning flags are displayed
and the WBC results have the
∗ flag, meaning that the WBC
three-part differential does not
seem to be correct.
In this patient result, the L
warning flag means that the
RBC-LYM discriminator is not
sure and that is why the W
warning flag (WBC three part
warning) appears in the last
line.
At the bottom of the screen, warning flags are displayed and the WBC results have the ∗ flag, meaning that the
WBC three-part differential does not seem to be correct.
In this patient result, the L warning flag means that the RBC-LYM discriminator is not sure and that is why the W
warning flag (WBC three part warning) appears in the last line.
With a little diagnostic experience, the User can accept the results, because just a very small part of the RBC is in
the LYM channel. (The discriminator is in the minimum point of the dotted RBC line) Similarly, the MID population
seems to be correct, thus the results can be accepted.
29/44
Second panel of the result screen including the PLT
distribution curve and measuring times.
7.1.6 Prediluted Mode

The software has a special Prediluted mode, useful in the following situations:
− If sample values are above the linearity range (see section 4.4)
− In case of very small sample volumes
− In case of capillary blood samples
In this Prediluted mode, you have to make an external 1+3 predilution, as in the following example:
Predilution: 1 UNIT OF SAMPLE + 3 UNITS OF [DIL] !
Example: If 20 μl capillary tubes are used for blood collection, one would add 60 μl of pure [DIL] to create a proper
predilution.
Measure local menu <MEASURE LOCAL MENU>
1.Patient type ? To select Prediluted mode, you must enable it in the
? 2.Prediluted mode
3.Maintenance ? Measure local menu. Now, the instrument is ready to
4.Repeat last sample measure the prediluted sample.
5.Limits ?
1+3 warning flag will appear on the WBC histogram of
the result screen.
Note: The instrument is capable of measuring two kinds of prediluted mode 1+3 and 1+10. The user cannot
change these modes. Contact service for further information.
The results are corrected with the predilution factor (1+3) automatically.
Prediluted mode has its own calibration factors. To calibrate the instrument for this mode, see the Calibration
settings section of this manual.
To disable Prediluted mode, you must re-enter Measure local menu and deselect its box.
Measure local menu <MEASURE LOCAL MENU>
1. Cleaning MAINTENANCE (3)
2. Priming ?
3. Drain chamber From the Measure local menu, you can also access
some parts of the maintenance menu. There you can
make priming, cleaning, or draining of the chamber.
7.1.7 [LYSE] Boost (for Veterinary Mode)

Would you find, that the preset [LYSE] volume is not
giving satisfactory results, you can modify the actually
used [LYSE] volume (± 0.2 ml), by pressing the up and
down arrows on the keypad. A small L+, L++ (+0.2ml), or
L-, L-- (-0.2 ml) sign indicates this change on the screen.
For further information, see Appendix E: Finding the
correct [LYSE] volume for vet applications.

7.2 Quality Control
By measuring control materials, day-to-day reproducibility can be monitored. In this submenu, both target value
and acceptable ranges for each parameter can be determined for the different QC levels.
The HumaCount provides six different Quality Control profiles, so-called levels. You can set up six individual
reference sheets for each control material (e.g. low, normal and high control blood). QC measurement results will
be added to the selected level is indicated at the top right corner.
The target values of the control material should be set only once, at the beginning of the QC measurements.
Resetting parameters deletes previous QC results of the active level.
CAUTION!
Any change in the QC material setting deletes previous QC results, therefore it is strongly recommended to have
them printed out before making any changes to parameters.
Quality control QUALITY CONTROL (6)

1.Set QC reference This menu allows setting and monitoring data related
2.QC measure to the QC procedure.
3.View table of QC measures
4.View QC diagram Use commercially available control material. The
5.Set QC level ?
Actual QC level: 1 preparation and measurement process is the same as
with patient samples.
Set QC level QUALITY CONTROL (6)

? 1. QC Level 1 SET QC LEVEL (5)
? 2. QC Level 2 Select the level you wish to use.
? 3. QC Level 3
? 4. QC Level 4 The active level is displayed in the top right corner on
? 5. QC Level 5
? 6. QC Level 6 QC related screens.
QC reference values QUALITY CONTROL (5)

QC Level: 1 SET QC REFERENCE (1)
LOT No.: __________________
Exp. date: 12.05.2001. Both target values and acceptable ranges can be
WBC 5.5 - 19.5 10^9/l specified. Only the parameters displayed on these
RBC 5.00 - 10.00 10^12/l
HGB 80 - 150 g/l screens can be specified. Modify displayed values using
HCT 24.0 - 45.0 % the numerical keyboard. Pressing the OK button
MCV 39 - 55 fl
validates values. To move on to further parameters,
press the page down function key.
Quality control measurements can only be made after an optimal blank measurement result has been accepted
(all parameters were in the 1st range).
QUALITY CONTROL (5)
QC MEASURE (2)
After selecting target values (or targeted level), select
this menu to do a QC measurement. After the
measurement has been completed, the following result
screen will be displayed. It is similar to the normal
measurement, but in the first line there is Quality
Control as an ID.
CAUTION! A result will be accepted only if it is confirmed with the key.
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7.2.1 QC Database
The database of measured and stored QC results can be displayed at any time in table or graphic (Levy-Jennings)
formats. The QC measurement results will have subsequent ID numbers.
SmpID Date PatID

QUALITY CONTROL (5)
?3 2003.05.02 07:06 VIEW TABLE OF QC MEASURES (3)
?4 2003.05.03 07:12
?5 2003.05.04 07:02 Move the selection bar over entries with ⁭ and ↓
?6 2003.05.05 07:36 buttons.
?7 2003.05.08 06:56
?8 2003.05.09 07:01 Moving among parameters with Å and Æ buttons.
?9 2003.05.10 07:02
? 10 2003.05.11 0650
CAUTION! Any change in the QC material settings is followed by deletion of the QC database, so it is strongly
recommended to print them out before modification.
The analyzer makes graphic figures of the primary parameters (WBC, RBC, HGB, HCT, MCV and PLT).
QUALITY CONTROL (5)
VIEW QC DIAGRAM (4)
Assigned values (target value and accepted range) as well as averages, standard deviations (StDev) and coefficients
of variation (CVar) are calculated based on the QC measurements and are displayed together with Levy-Jennings
charts. The dotted lines show the acceptable range.
7.3 Auto Stand-by

In measurement mode, the analyzer will automatically go to stand-by if it is left alone - without starting any new
measurement - for more than 15 minutes. While in stand-by, the aspirating tip is inside the analyzer and the
chamber is filled with [DIL]. When the sampling bar is pressed, the chamber will be cleaned, the tip comes out and
the analyzer is ready for the next measurement. The same process is performed when entering and leaving
measurement mode.
7.4 Printouts
When required, the following items can be sent to an external printer by pressing the function key button.
1. Database result(s) (table format).
2. Database (specified patient results with histograms).
3. QC result (Levy-Jennings chart).
4. QC result(s) (table format).
5. Last measured blank result.
6. Last measured patient result (with histograms).
7. Last measured QC result.
8. Device Information and Device Statistics.
9. Self test result.
10. Set parameters.
Different printout formats of typical patient-result printouts are shown in the next figures (the appropriate
printout format can be selected in SETTINGS/PRINTER SETTINGS submenu – see 0).

Full printout format with histograms:
Date, time and

sample ID
Hematology-1 07.03.2003 15:38 #2 Female

Patient
Laboratory
t
name
Normal
range
In this printout normal ranges (limits), flags and warning flags are all enabled. The printing modes of these
parameters can be selected within PRINTER SETTINGS submenu.
If normal ranges are set, flags are enabled, and patient values are over or below the limits specified, the result out
of the range is marked with an +/- mark.
Normal printout format without histograms (Text only):
Hematology-1
07.03.2003 15:38 #2 Female
This printout format is similar to the previous one, but
it does not include the histograms. The laboratory
name has moved into the first line.
7.5 Patient Results Database Management

Patient results are stored in the memory in chronological order, and they can be retrieved at any time. Memorising
capacity is 2,000 measurements including the complete parameter list, histograms, flags, sample data, dates and
times of the measurements.
Database DATABASE (2)
1.View database From this menu monitoring of stored measurements
2.Backup database can be done. Select item 1 to view the database in table
3.Restore and view
format.
33/44
SmpID Date PatID
DATABASE (2)
?7 2003.05.02 14:56 20000502a12 VIEW DATABASE (1)
¦8 2003.05.04 14:59 HR0058AS4
? High05 2003.05.04 15:06 PWF55A Pressing ← or → button accesses the remaining, non-
? 08 2003.05.04 15:08 LNK23-B visible parameter results. With ↑ or ↓ button you can
? 12A7 2003.05.04 15:15 MK4FED
¦ UF6A8 2003.05.04 16:00 550462L scroll between the results one-by-one. Pressing the 3
? HEM2 2003.05.04 17:26 HEMA0034A and 9 buttons has the same effect as PageUp and
¦ PR02 2003.05.04 17:29 ZZ3ZH
PageDown scrolling keys.
Select patient results by pressing the OK button. Its box
will be filled.
From the database table screen, WBC, RBC and PLT histograms can be displayed by pressing . By pressing the
key, the second panel with PLT results can be accessed.
Step-by-step browsing among histograms of the selected tests is made by pressing LEFT and RIGHT ARROW
function key buttons.( and )
Database local menu <DATABASE LOCAL MENU>

1.Go to specified record From the database table screen, you can go to the
2.Selection ?
3.Change sort order ? Database local menu by pressing the key.
4.Backup selected records
5.Delete selected records
Go to specified record <DATABASE LOCAL MENU>

Go to the first record measured after: GO TO SPECIFIED RECORD (1)
02.05.2003. 00:00 Item 1 brings up a screen asking for parameters
and has Sample ID:
defining any given sample (date, time ID) and jumps to
and has Patient ID: it. If any ID is left as 0, it means searching only by
date/time.
Selection <DATABASE LOCAL MENU>

1.Select by date, time and ID SELECTION (2)
2.Select all Besides checking samples one-by-one, selection can
3.Deselect all
also be done within Database local menu.
SELECT ALL checks all boxes, DESELECT ALL clears all
boxes.
Select specified data records <DATABASE LOCAL MENU>

Select data records measured between: SELECTION (2)
02.05.2003. 00:00… 02.05.2003. 23:59 SELECT BY DATE, TIME AND ID (2)
and has Sample ID in range:
Select a range by date, time and/or ID number (see next
and has Patient ID: screen)
Entering 0 as ID# means searching only by date.
Corresponding results will be marked with a filled box.
Change sort order <DATABASE LOCAL MENU>

? 1. Unsorted CHANGE SORT ORDER (3)
? 2. Sort by time The way results are displayed can be selected within
? 3. Sort by Sample ID
? 4. Sort by Patient ID this menu.
If set, samples appear according to the rule selected.

7.6 Data Back Up
This submenu allows backing up stored data to a USB flash storage device, and monitoring external database
stored to a USB flash device. Before menu selection, prepare a USB flash storage device. You will need to connect it
to the USB socket located on the back of the analyzer.
(Instrument software allows selection of “Floppy drive” as backup media. This feature show ever only supported on
analyzers with an existing built-in floppy drive.)
Back up database
1.Back up one day
2.Back up selected records
DATABASE (2)
Backup data BACKUP DATABASE (2)
BACKUP ONE
Day to back up: DAY (1)
2003.05.24.
Specify the day whose
records you wish to
backup to backup.
When you have selected the day or data to be saved, and confirmed it with the key, the instrument will
prompt you for the storage device. (In case “Floppy” is selected for backup, the SW will calculate the number of
necessary floppy disks).
! Message 5104/12210
35 data record(s) will be saved on 1 disk(s).
Insert an empty floppy disk!
Possible error messages related to backing up data:

! Message 5106/12210 The instrument gives this warning in case you tried to
No such type of data. save data of a day, which had no data, or no data are
selected.
STOP! Error 1300/12210 This warning appears, if the disk you inserted had
Cannot write archive data! Check disk! errors on it, or was write-protected.
It may be unformatted, full, or bad! Check the write protection of the disk or if necessary,
Do you want to retry?
insert a new, formatted disk.
35/44
7.7 Maintenance
From this submenu, the User can initiate maintenance procedures such as cleaning, priming, draining and
preparing the analyzer for shipment.
Maintenance MAINTENANCE (3)
1. Cleaning Select the required submenu.
2. Priming ?
3. Drain chamber
4. Empty waste container
5. Diagnostics ?
6. Service
7.7.1 Cleaning
Select item 1 (CLEANING) in the above MAINTENANCE menu.
This action is recommended in case any clogging problem is experienced (C error flag).
This is a relatively strong decontamination process, cleaning out possible dirt or clog from the system using high
voltage electronic pulses, [CLEAN] solution and high-pressure backflush.
7.7.2 Priming
Priming MAINTENANCE (3)

1. Prime all PRIMING (2)
2. Prime diluent During the priming cycle, the fluidics system gets
3. Prime lyse
4. Prime cleaner rinsed with a relatively large amount of [DIL] . It differs
from the process in a start-up procedure; as in the
latter case a simple filling up of the fluidics is
performed.
If fluid sensors are on, then the analyzer makes these procedures automatically, otherwise the User must initiate
them activating the appropriate item within this submenu.
7.7.3 Draining
Draining is used to drain the chamber before servicing (e. g. manual cleaning, dismounting of the aperture).
7.7.4 Manual Cleaning of the Aperture

The risk of clogging of the aperture by protein build-up is held at a minimum level in several ways. These are as
follows:
− The specific cleaning cycle can be executed from MAINTENANCE/CLEANING submenu.
− Aspiration of the specific [CLEAN] as patient sample.
− Applying high-voltage electric impulses to the aperture. (Done after each measurement.)
If manual cleaning of the aperture is required, instructions listed below should be followed:
1. Drain the chamber: MAINTENANCE/DRAIN
2. Open the side door (right side).
3. Remove the reference electrode connection and the U-shaped metal fixing.
4. Remove the aperture assembly from the measuring chamber.
5. Pull out the measuring tube from the part containing the electrode.
6. Cleaning of the aperture can be performed by placing it into a 10% hypochlorite solution, or into an ultrasonic
cleaning bath for approximately 1 minute.
7. Rinse well with distilled water.
8. Put back the measuring tube to the electrode holding part, and the U-shaped metal fixing.
9. Install the aperture in the measuring chamber, and connect the reference electrode.
10. Execute a priming cycle.
11. Measure blank until you reach acceptable blank results.
7.7.5 Weekly Maintenance

User should do weekly maintenance on the first workday, before starting up the analyzer.

7.7.5.1 Cleaning washing head
There could be salt build-up in the lower surface of the
washing head, which may cause malfunction during
operation. User should clean the lower surface of the
aspirating tip cleaning head using a soft cloth
immersed in warm tap water to remove salt build-up.
There could be salt build-up in the lower surface of the washing head, which may cause malfunction during
operation. User should clean the lower surface of the aspirating tip cleaning head using a soft cloth immersed in
warm tap water to remove salt build-up.
See steps 1 and 2 below:
− Exit Measurement menu and wait until needle stops, then open side door.
− To clean, gently rub the lower surface of the washing head, and then close the side door.
7.7.5.2 Peristaltic pump maintenance
The pump installed in the instrument is maintenance free. However, would you experience leakage from the pump,
or vacuum error, you may replace the tube used. Remove the tubes from the pump by opening the screw
connectors.
Push in the two sides of the pump cassette.
Pull the cassette off the pump.
Pushing aside the two tubes, bend the tube out of the pump.
Now you have the tube as figure 1 shows.
1.
Using a standard screwdriver, ease the tube on the plastic connector, and pull the tube off.
Repeat the same procedure on the other end of the tube.
Now you can pull the plastic holders off the tube. Retain all parts except the old tube.
Using the new pump tube, slide the two grey plastic parts onto the new tube. Make sure they are aligned as shown
on figure 1. Insert the 2 white plastic connectors into the ends of the tube. The new set must look like the tube on
figure 1.
Put the tube back into the pump mechanics, and drive the grey plastic parts into their seats as figure 2 indicates.
(view from the “top” of the pump)
2.
Slide the cassette housing back. There are pins on the cassette, make sure to drive them in their paths.
The cassette must click into its place.
37/44
7.8 Diagnostics
The DIAGNOSTICS submenu provides important information about the analyzer, statistics and the built-in Self test.
Diagnostics MAINTENANCE (3)
1. Device information DIAGNOSTICS (5)
2. Statistics Select the desired item.
3. Self test
Device information MAINTENANCE (3)

Model: HUMACOUNT DIAGNOSTICS (5)
Serial No.: 1031 DEVICE INFORMATION (1)
Version: 2.3
Compiled: Dec 22. 2000 Here, device-specific information can be retrieved.
Model name, serial number, software version and the
date of the compilation of the software.
7.8.1 Device Statistics
Device statistics MAINTENANCE (3)

Measurements 6283 DIAGNOSTICS (5)
WBC clogging 4 STATISTICS (2)
RBC clogging 3
Vacuum error 1 This menu includes important information about the
Comm error 0 measurements: the total number of measurements,
MHori error 2
MVert error 0 clogging, vacuum and the other error numbers.
Mdilu error 0
7.8.2 Self Test

Self test is a procedure to check for proper operation of essential components of the instrument.
Self test should be performed in the following cases:
− Installation.
− After replacing any component.
− In case of extended time out of use.
The automatic Self test procedure can be initiated from the MAINTENANCE menu. During the test, you can see its
progress. The components, that have passed the test, get checked.
Self test results After completion of the Self test procedure, results will
Date of testing: 17.11.2003 be displayed.
Model: HUMACOUNT
Serial No: 1031 The first panel of result screen includes the date of
Version: 2.3 testing and Device Information.
Compiled: Dec 22. 2000
PCPNIF Firmware version ---
MPU Firmware version: 2.0
Self test results The second and third panels of the result screen include
HGB dark: 0 OK every test result. At the end of the result line, OK, HIGH,
HGB light 17723 OK LOW, or ERROR is displayed, which means that the
Electr. Voltage: 51.2 V OK
current: 879 uA OK actual test result is at the normal range (OK), higher
offset -1.9 mV OK (HIGH), lower (LOW) than the pre-determined limits, or
Ampl. test: 20000 pls OK
peak: 1621 mV OK the result is an error (ERROR).
dev: 53 mV OK

Self test results On the third panel of the result screen, the overall test
Noise test: 1 pls/5 sec OK result is displayed which can be Successful (in case of
Atm 978 mBar OK every test result is OK), or Errors found (if HIGH, LOW or
Vacuum: 308 mBar OK
drift: 2 mBar/10sec OK ERROR results appear).
Overall result: Successful
7.9 Software Update

The instrument software can be easily updated by the User, following the steps below:
− Shut down the instrument, and switch it off.
− Insert the upgrade floppy disk USB device.
− Switch on the instrument and follow the on-screen instructions.
− When instructed, remove the disk from the drive.
At the next start-up, the instrument will run the new software.
39/44
8 APPENDIX "A": REAGENT SOLUTIONS AND CONSUMPTION
Reagents supplied by Human GmbH are the only ones recommended for use with the analyzer.
1. [DIL] : An isotonic saline solution used to dilute whole blood specimens and to rinse the fluidic
system between measuring procedures.
HC-DILUENT Cat.- No.: 17400/10 (20 litres)
2. [LYSE] : Used to prepare blood hemolysate for WBC and HGB measurement.
HC - [LYSE] Cat.- No.: 17400/20 (1 litre)
3. [CLEAN] : Used to perform cleaning process of the fluidics.

HC- [CLEANER] Cat.- No.: 17400/30 (1 litre)
Average reagent consumption of the HumaCount:

Number of daily [DIL] ml/test [LYSE] ml/test [CLEAN] ml/test
measurements
1 259 15 16
2 146 7,7 8,6
5 79 3,6 4,0
10 56 2,3 2,5
20 45 1,6 1,8
50 39 1,2 1,3
100 36 1,0 1,2

9 APPENDIX "B": TECHNICAL SPECIFICATIONS
Sample volume: 25 μl whole blood (50 μl in Prediluted mode)
Aperture diameter: 80 μm
Characteristics: Accuracy Reproducibility Carry over Test range
WBC 3% < 3% < 1% 4.0 – 20.0
RBC 2% < 2% <1% 4.00 – 5.00
HCT 2% < 2% <1% 30.0 – 50.0
MCV 2% < 1% N/A 70 – 100
HGB 2% < 2% <1% 100 – 160
PLT 4% < 4% <3% 200 – 400
Fault statistics: RBC and WBC clogging < 3% of measurements (normal use)
Clog prevention: High-voltage burn and chemical cleaning of the aperture in each measurement cycle
using [CLEAN]
Cleaning procedure: High-voltage burst on the aperture, high-pressure backflush and chemical cleaning of
aperture using [CLEAN]
Quality control: 6 QC levels (profiles) including: average, ± range, SD and CV for all measured and
calculated parameters, 16- and 64-day Levy-Jennings charts, separate QC database
Calibration: Automatic (by calibrator) with 1, 2 or 3 measurements, or factorial (manual) calibration of
WBC, HGB, RBC, PLT, MCV, RDW, MPV, PDW
Automatic and factorial calibration of Prediluted mode
Monitoring of calibration factors by calibration events (not available for Prediluted mode)
On-board CPU: Pentium™ PC
Data storing capacity: 2,000 results, including histograms (8Mbytes DiskOnChip module)
Interfaces: RS 232 (computer) in 150, 300, 600, 1200, 2400, 3600, 4800, 9600, 14400, 19200, 38400,
57600, 115200 baud rate (8 data bit, no parity, 1 stop bit)
Parallel output (printer) in HP PCL4, Epson 9-pin, Epson 24-pin, Canon BJC, Seiko DPU-414
or compatible mode
3.5” floppy disk drive
PC standard external keyboard, USA layout
Display: 240x128 dots graphic, backlit LCD
Keyboard: 24 buttons foil, START bar
Dimensions: 450x310x350 mm
Net weight: 14 kg
Power requirements: 110/230 V; 50/60Hz; 230VA
Installation category: II. (OverVoltage)
Primary mains fuse: T5A/250V
Protect class: I.
Operating temperature: 10 - 35 °C
41/44
10 APPENDIX "C": FLUIDIC SCHEMATICS
V11 DilWash
1
V13 DilNeedle
3
1
2
2 1
V12 DilChamber
DILUENT
2
3
V14 LyseWbc
1 2
LDL
3
Lyse Diluent & Cleaner V5 Cleaner
LDD
Sensor Sensor
3
V15 DilAperture M1
1 2 CLEANER
Hor
M2
Micro Macro Lyse
Ver
1
Pump dimensions:
Macro O16 x 40 mm 8 ml
2
Dil M3 V3 Bubble Micro O1.6 x 40 mm 80 µl
P HGB
Pressure Lyse O9.2 x 40 mm 2.6 ml
Meter RBC/WBC
LYSE
Dilutions:
Puffer 1. 25 µl SA. + 4.0 ml DIL MIX 1:160
Reservoir V1 DrainChamber V2 DrainAperture 2. 25 µl MIX + 5.0 ml DIL RBC 1:32.000
3. 4 ml MIX + 0.9 ml LY. WBC 1:196
2 1
Pump 3
V4 DrainPuffer
1 2
LDx Liquid Detector 2-way Valve 3-way Valve
WASTE Closed = Off 3 1-3 = Off
M1 Stepper Motor Open = On 2-3 = On

11 APPENDIX "D": ACCESSORIES
This appendix includes the contents of the HumaCount pack:
− HumaCount Hematology Analyzer.
− HumaCount User' Manual.
− HumaCount Reagent Tubes (marked with colours) :
- Diluent tube (green) Diluent
- Lyse tube (yellow) Lyse
- Clean tube (blue) Clean
- Waste tube (red)
HumaCount Cleaning Tube Kit:

−
− HumaCount Caps for reagent containers
(Marked with the same colours as the Reagent Tubes)
− HumaCount Power cable.
− HumaCount pump tube.
43/44
12 APPENDIX “E”: FINDING THE CORRECT [LYSE] VOLUME FOR VETERINARY APPLICATIONS
The software running on the instrument uses some default [LYSE] volumes, pre-set at software installation.
However, the required [LYSE] volume depends on several parameters. [LYSE] volume can be adjusted in the
SETTINGS/LIMITS menu for each species. An additional option to modify [LYSE] quantity by ± 0.2 ml is available
during analysis. (see 7.1.6.)
The manufacturer cannot guarantee that pre-set volumes will always give the best results. It is therefore strongly
recommended that the user oneself shall find the necessary volumes for the veterinary application. This requires
some experiments, but the result validated a user doing vet practice will be worth it.
The two most important parameters influencing lysing are lysing time and [LYSE] quantity. You cannot change the
lysing time, as it is fine-tuned for the [LYSE] supplied by HUMAN GmbH.
Above you could read that [LYSE] of quantity can be adjusted either at patient limits, or right before measurement.
In the following figures, you can see examples of over- or under-lysed samples.
Press ↑ to increase the [LYSE] quantity (+0.1 ml) if the separation between lysed RBCs and WBC populations is
poorly differentiated, resulting in increased WBC and LYM counts.
Under-lysed sample, some RBCs counted The same sample with [LYSE] boost (+0.1 ml)
as WBCs WBC =13.7, good 3-part differential
WBC = 16.9, LYM% high
You can see that a lower amount of [LYSE] will result in a less differentiated curve.
If you increase the [LYSE] quantity it will be more differentiated, and well evaluated.
Press ↓ to decrease the [LYSE] amount (-0.1 ml) if the WBC histogram seems to be shrunk to the left, i.e. the
different WBC populations are overlapped. This can inhibit proper separation of WBC populations.
Over-lysed sample, LYM and GRA overlapped The same sample with [LYSE] decreased (– 0.1 ml)
WBC = 20.6, poor 3-part differential WBC = 21.0, good 3-part differential
An over lysed sample will have all its cells shifted down towards the smaller cells. It is because of too much lysing
reagent shrinking all cells to the size of their nuclei.
With [LYSE] quantity decreased, the cells will not shrink that much, and can be differentiated easily.
Icons used in the software

HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 · 65205 Wiesbaden · Germany
| Tel.: +49 61 22/99 88-0 · Fax: +49 61 22/99 88-100
| e-Mail: human@human.de · www.human.de

Гематологический Анализатор HumaCount (Human) РП

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Гематологический Анализатор HumaCount (Human) РП

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HumaCount

4 04/2008-03 Diagnostic flags, requires software 3.23 or higher

3 INTENDED USE OF THE INSTRUMENT [IVD]

4 GENERAL SAFETY WARNINGS

1 INTRODUCTION, INTENDED USE 3

HumaCount | User Manual 2/44

2.1 Parts of the Analyzer

HumaCount | User Manual 4/44

2.1.1-1: Front view

1. Floppy disk drive (old instruments only)

2.1.2-1: Rear view

1. Reagent tubing connections

HumaCount | User Manual 6/44

2. [LYSE]: HC-Lyse CF Cat. No.: 17400/20 (1 litre)

Components (active ingredients) Specification

3. [CLEAN]: HC-Cleaner Cat. No.: 17400/30 (1 litre)

Components (active ingredients) Specification

2.3 Fluidic Schematics

2.5 Control Panels

2.5.1 Sampling Bar

2.5.2 Status LED

• Yellow The analyzer is performing a maintenance process, or it is in stand-by.

HumaCount | User Manual 8/44

Function key Action triggered

Patient type selection

3.2 Menu System

HumaCount | User Manual 10/44

Measure Measure Local Prediluted mode Cleaning

Set QC reference QC level 1 Set date and time

* if multi-user mode is enabled

4.1 Impedance Method

4.2 Principle of the HGB Measurement

HumaCount | User Manual 12/44

1.: RBC LYM discriminator

Parameter Linearity Ranges Maximum Unit

RBC 0...15 20 1012 cells/litre

PLT 0...700 1000 109 cells/litre

HGB 0...250 400 g/l

The linearity ranges for 1:3 pre-diluted mode:

RBC 2...40 60 1012 cells/litre

PLT 200...3000 4000 109 cells/litre

HumaCount | User Manual 14/44

5.2 Connecting Reagent Containers

5.3 Connecting Power Cord

5.5 Connecting the Instrument to a Host Computer

5.6 Turning the Instrument ON

5.7 Display Contrast Setting

Exit EXIT (7)

! Message 5002/19300 Next, you should connect at least 100 ml of distilled

HumaCount | User Manual 16/44

6.1.1 General Settings

Enable diagnostic flags

Settings The SETTINGS sub-menu allows you to set customer-

6.2 Setting Date and Time

Set date and time SETTINGS (6)

Confirm by pressing the button.

6.4 Results Units Setting

Units SETTINGS (6)

The possible units for above parameters are as follows:

6.5 Setting Reference Limits

HumaCount | User Manual 18/44

Limits SETTINGS (6)

Patient limits Patient limits