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HumaCount 5L
| User Manual
Cat No. 16430/1

REVISION LIST OF THE MANUAL
Rev. /DATE REVISION DESCRIPTION
01/2010-06 First edition
02/2011-03 Update for software version 1.1.623
03/2011-12 Correction Pre-dilution
SYSTEM VERSION
COPYRIGHT
Copyright 2011, Human GmbH, 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 GmbH 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 5
1.1 INTRODUCTION 5
1.2 USER WARRANTY 5
1.3 INTENDED USE OF THE INSTRUMENT [IVD] 6
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 7
1.6 INSTRUMENT DISINFECTION 7
1.7 WARNING SYMBOLS 8
2 SYSTEM DESCRIPTION 11
2.1 INSTALLATION AND FIRST TIME USE 11
2.1.1 Prior the Installation 11
2.1.2 Performing the Installation 14
2.1.3 First startup 18
2.1.4 Primary Settings 22
2.1.5 How to proceed 25
2.1.6 Accessories 26
2.2 THE HUMACOUNT 5L 26
2.2.1 General Description 26
2.2.2 Technical data 27
2.2.3 Measured Parameters 28
2.2.4 Reagent and Control Materials 30
2.2.5 Measurement Principles 31
2.2.6 Identifying parts of the analyzer 35
2.2.7 Right side Assembly 39
2.3 USER INTERFACE 41
2.3.1 Using the touch screen 41
2.3.2 Using the Start-Button 42
2.3.3 Using external mouse 42
2.3.4 Using external keyboard 42
2.3.5 Using the virtual key-pads 43
2.3.6 Using the GUI 44
2.3.7 The menu System 48
2.3.8 Safety and Access codes 53
3 ROUTINE UTILIZATION 55
3.1 START-UP AND SHUT-DOWN THE HUMACOUNT 5L 56
3.1.1 From power-off to ready to measure 57
3.2 MEASUREMENT 61
3.2.1 Usable samples 61
3.2.2 Sample Types and Modes 63
3.2.3 Sample Identification 64
3.2.4 Result Display 77
3.2.5 Printing Reports 82
3.2.6 The Measurement Process 82
3.3 RESULT INTERPRETATION 83
3.3.1 The result screen 83
3.3.2 Parameter information 84
3.3.3 Scatter Diagrams 85
3.3.4 Warnings 87
3.4 QUALITY CONTROL 91
3.4.1 Set QC Reference 92
3.4.2 QC Measure 93
3.4.3 View QC References 93
3.4.4 View QC Data 93
3.4.5 View QC Diagrams 93
4 DATABASE FUNCTIONS 101

4.1 DATABASE OVERVIEW 101
4.1.1 Scrolling the database View 102
4.2 CALIBRATION 109
4.3 CALIBRATING THE HUMACOUNT 5L 110
4.3.1 View Calibrations 112
4.4 PATIENTS 113
4.5 SETTINGS 114
4.6 CUSTOMIZE SETTINGS 115
4.7 LABORATORY SETTINGS 116
4.8 EXTERNAL DEVICES 116
4.9 SYSTEM SETTINGS 117
4.10 UNITS 118
4.10.1 Printer Settings 119
4.11 PROFILE LIMITS SETTINGS 120
4.12 USER SETTINGS 121
4.13 DATE AND TIME ADJUSTMENT 122
4.14 REAGENT LOCKING 122
5 MAINTENANCE 125
5.1 OPENING THE FRONT PANEL 125
CONTENTS
5.2 CLOSING THE FRONT PANEL 125

5.2.1 Removing The Side Panels 126
5.2.2 User Maintainable Parts Of The Analyzer 126
5.2.3 Maintenance Programs In The Analyzer 127
5.2.4 Cleaning The Shear Valve 128
5.2.5 Daily cleaning 134
5.2.6 Special cleaning procedure 134
5.2.7 Replacing Reagents 135
6 TROUBLESHOOTING 137
6.1 SOFTWARE ERROR MESSAGES 137
6.1.1 Pneumatic error messages 137
6.1.2 Mechanical Problems 138
6.1.3 Sample Rotor (SR) Failures 139
6.1.4 Needle Mechanics, Vertical Motor (Mvert) Problems 139
6.1.5 Shear Valve (SV) Related Errors 140
6.1.6 Dilutor Errors 140
6.1.7 Priming Problems 140
6.1.8 Electronics Related Problems 141
6.2 MEASUREMENT RESULTS RELATED PROBLEMS 142
6.2.1 Fluctuating PLT background values 142
6.2.2 Long, smeared population 142
6.3 INSTRUMENT DIAGNOSTICS 142
6.3.1 Self Test Of The Analyzer 143
6.3.2 Daily Log 144
6.3.3 Reagent Status 145
6.3.4 Statistics 146
6.3.5 Information 146
7 APPENDIX 147
7.1 REAGENT CONSUMPTION 147
7.2 DISPLAY RANGE 148
7.2.1 Fluidic System 149
7.3 PRINTED REPORT FORMATS 150
7.4 PERFORMANCE DATA 154
7.4.1 Precision 154
7.5 TAB FILE FORMAT 155
SAFETY INSTRUCTIONS 5
1 SAFETY INSTRUCTIONS
1.1 Introduction
This manual is considered as a part of the instrument; it has to be at the
operators hand as well as at the maintenance operators availability. For
accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument damage or personal
injurycarefully 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.
1.2 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 manufacturers 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 reported to the freight carrier for settlement or
claim
6
1.3 Intended Use of the Instrument [IVD]

The instrument is intended for in vitro diagnostic application by profes-
sional users. It 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.
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
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.
The analyzer weighs 35kg (~77lbs), please do not attempt to move it alone, the
instrument should always be moved by two persons, holding the analyzers two
sides and hold it in a nearly upright position.
To avoid injury, always kneel down before lifting the unit from lower positions.
For the longer transportation, please, drain the reagents and repackage the
HumaCount 5L.
HumaCount 5L | User manual

Make sure to retain packaging material for safe transportation and storage in
the future. In case of inactivity of analyzer or storage, please, drain the reagents
and repackage the HumaCount 5L. Do not expose the HumaCount 5L to direct
sun shine or extreme temperature condition or humidity (>80%)
The analyzer operates with chemically and biologically active reagents.
Direct (skin) contact with these reagents should be avoided. Please read reagent
descriptions carefully for possible emergency actions.
1.5 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 off 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 re-
gulations.
1.6 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.
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 authoritys
interventions.
8
1.7 Warning Symbols

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 consi-
dered as potentially infectious.
For safety reasons, we have labeled instruments with the BIOHAZARD war-
ning label below.
The sample and the waste are potentially

Biohazard
infectious materials.
Reagents may cause corrosion or skin

Corrosive
irritation.
Sharp needle
The sampling needle may cause injury.
warning
This analyzer contains electronic components.

Please handle electronic waste adhering to lo-
cal or federal regulations.

Notes:
10

SYSTEM DESCRIPTION 11
2 SYSTEM DESCRIPTION
2.1 Installation and first time use

HumaCount 5L is a complex measuring device. As such, there are some
precautions you must take before turning the analyzer on. First of all, you should
read this manual, especially this chapter.
2.1.1 PRIOR THE INSTALLATION

Before you start the installation please ensure that the following conditions are
fulfilled:
- A suitable location is found for the HumaCount 5L instrument;

- The normal ranges are decided. See chapter 2.1.4.3.
- You will have time enough to perform the necessary steps calm and
precisely. The installation and the first start-up takes proximately 3-4 hours;
- At least 2 persons are available to perform the installation.(Not included the
HUMAN GmbH qualified service personnel);
- You have the contact information to the HUMAN GmbH representative/
service;
- The presence of the HUMAN GmbH qualified service personnel is confirmed
and scheduled;
- Local support (IT specialist, electrician) is available if necessary during the
installation;
- Check chapter 1 .
2.1.1.1 Select a suitable location

When selecting a location for the HumaCount 5L please take into account your It is important to install the
requirements (safety, ergonomics) and the requirement of the HumaCount 5L instrument in a suitable
(safety, operation, environment). Check chapter 1. location. A poor location can
adversely affect its performance.
2.1.1.2 Environmental conditions Consider the space requirements.
Operate HumaCount 5L within the ambient temperature range of 15-30C
(~59-86 F) and relative humidity of 10% - 80%. The optimum operating
temperature is 25C (~77F).
Avoid using the instrument in areas of extreme high or low temperatures or
where it is exposed to direct sunlight. If it is kept at a temperature less than
10C (~50F), or more than 15C below the ambient temperature, then the
12
The HumaCount 5L is instrument should be allowed to sit for an hour at the correct room temperature
designed for laboratory oper- before use.
ation. Mobile operation is not Reagents should be stored at a temperature range of 15-30C (~59-86 F).
supported. Operate HumaCount The instrument should be placed in a well-ventilated location. The instrument
5L within the ambient should not be placed near potentially interfering devices capable of emitting
temperature range of 15-30C radio frequencies (e.g. radio or television receiver, radars, centrifuge, X-ray
(59-98 F) and maximum relative devices, fans, etc.).
humidity of 80%. The optimum Operation at an altitude over 3000 meters (~9800 ft) is not recommended.
operating temperature is 25C. This instrument is designed to be safe for transient voltages to INSTALLATION
Reagents should be stored CATEGORY II and POLLUTION DEGREE 2.
at a temperature range of Environmental and electrical requirements have been provided to insure the
15-30C. The HumaCount 5L accuracy and precision of the instrument and maintain a high level of
operates properly up to operational safety for lab personnel.
3000 meters above sea-level. Do
not place the reagent containers The image below shows the HumaCount 5L with its optional Auto Sampler unit:
to a higher position than Huma-
Count 5L. This is to avoid uninten-
tional spilling of reagents. The
vertical distance between the
reagent container and Huma-
Count 5L must not be more than
120 centimeter.
FIGURE 1

The image below shows a single HumaCount 5L:
FIGURE 2
2.1.1.3 Electrical requirements

HumaCount 5L comes with a power cord appropriate for your power system.
Proper use of the appropriate power cord assures adequate grounding of the
system.
2.1.1.4 Mechanical issues

The stand-alone HumaCount 5L weights 35 Kg (~77 lbs), the HumaCount 5L with To allow reliable operation
Autosampler, external keyboard, documents etc. can weight 60 Kg (~132 lbs). If and to provide a safe working
you decide to store the reagents on the same table, laboratory shelf, work-bench environment, make sure that the
were the HumaCount 5L installed then the weight of whole system can reach table supporting the unit is stable
100 Kg (~220 lbs). enough to carry the weight of the
HUMAN GmbH does recommend to place the reagents under table where the instrument and necessary
HumaCount 5L is installed. (You can save table-space, you dont need to lift the accessories. Reagents should be
reagent containers, and you can store a spare set of reagents under the table as placed below the supporting
well. desk, or next to the analyzer on
Please select a table, laboratory shelf, or other location which can support the the same level, not above the
weight of the HumaCount 5L and the accessories and free from vibrations. analyzer. Reagents below the
If you decide to drive the reagent-tubing through the tabletop then please drill analyzer save desk space.
the holes before the installation process starts.
14
2.1.1.5 Connection the reagents

The HumaCount 5L is capable to aspirate reagents from 1.2m (~4). (Measured
from the bottom of the reagent container to the table level where the Huma-
Count 5L is installed.)
You will use 3 input reagents and the waste-output. Select a location close to a
suitable drain. The waste container should be periodically emptied.
You can place the reagent below or on the same level where the HumaCount 5L
is installed. Do not place the reagents to a higher location than the bottom of
the HumaCount 5L, because in case of any tubing problem, valve error etc. the
reagent can spill out.
2.1.1.6 Power connection

The analyzer should only be Please check the power consumption of the additional devices (printer) as well.
operated from a wall outlet
meeting general specifications of 2.1.1.7 Connections to the peripherals
power input requirements: If you plan to connect the HumaCount 5Lto any external devices (printer, host-
110/220VAC; 47Hz to 63Hz. computer etc.) then prior the installation please check the possible cable paths.
Power Consumption: maximum If it is necessary then make all the preparations (cable-channels, cable-binders,
400 VA. If the power network is drilling trough tables, walls etc.) before the installation starts.
not reliable, contact your Although the Windows XP operating system can recognize several peripheral
representative for options (e.g. devices please prepare the installation material provided by the vendor of the
installation of an external UPS device.
module). Only the power cord
supplied with the instrument 2.1.1.8 Checking the delivery
should be used. Avoid using Upon receiving your HumaCount 5L instrument check:
extension cords. - If the shipment is not damaged;
- All the delivery data match.
In case of any problem please contact your sales representative, the service
representative, the delivery company.
Please do not open the delivery unless you have prior approval from your sales/
service representative.
The handling / opening of a delivery have several legal issues. Please check the
local regulations!
2.1.2 PERFORMING THE INSTALLATION

Start the installation only if all the pre-conditions are met. The HumaCount 5L
should be installed by trained and approved service personnel.

2.1.2.1 Content of the package

HumaCount 5L
After opening the packaging, you will find an accessory box. The analyzer is in
a plastic bag in between cushioning protective material. After opening the bag,
remove the silicone desiccants. The delivery should contain the following items:
- Accessories box (carton box) on top of the analyzer:
- Power cord;
- User Manual (this document);
- Sample adapter for the individual sample unit (1 pc);
- Reagent tube kit (in a plastic bag, with special caps);
- Maintenance kit:
- Preparing for shipment tube kit;
- Empty sample tube for cleaning process ;
- The HumaCount 5L.
Would any of the above be missing or damaged, please inform your Sales
Representative for further instructions.
Autosampler
If the optional Autosampler unit also delivered then the delivery should contain
the following items as well:
- The Autosampler unit;
- A sample-tray;
- 10 pieces of sample-racks.
Would any of the above be missing or damaged, please inform your Sales
Representative for further instructions.
2.1.2.2 Visual inspection

To ensure correct operation, and to check that the instrument has been
delivered to you without any damage, please check the following before
starting the unit for the first time:
HumaCount 5L:
- The front panel should have no cracks;
- The screen should have no cracks;
- No visible dents or bumps on instrument housing (front, side rear, top cover);
- Open the front panel of the unit:
- The front panel is easy to open and close (see chapter 2.2.6.1);
- Inspect that the syringes are not cracked;
- Check if the shear valve has the safety card installed;
- Check if there are no fluid inside the tubing;
- Check if there are no salt build-ups inside the tubing.
16
Autosampler:
- No visible dents or bumps on the housing of the Autosampler;
- The transparent cover opens and closes smoothly;
- The sample-tray and the racks have no visible damage.
2.1.2.3 Moving to the selected location

Check the presence of all necessary connections.
Move the HumaCount 5L to the selected location.
If it is hard to access the back of the HumaCount 5L after it is in the final location
then connect the reagent tubes to the HumaCount 5L but not to the reagent
containers. (For details see chapter 2.1.2.6.)
Be sure that the main switch (right next to the power connector) is in off
position.
2.1.2.4 Removing the safety card from the shear valve

In order to prevent the damage of the shear valve during transportation a
protective plastic card is placed between the ceramic disks of the shear valve.
Before using the HumaCount 5L instrument, this card must be removed.
Please perform the following steps:
- Open the cover of the equipment
- Locate the white plastic card in shear valve
- Pull out the card
- Check and tighten the locking screw of the shear valve if necessary
FIGURE 3

2.1.2.5 Connecting the Autosampler

If the optional Autosampler unit also purchased then:
- Remove the secondary cover-plate from the right-side cover-plate of the
HumaCount 5L;
- Check that the connection surface is clean and there are no blocking objects
(like hanging, swinging cables);
- Push the Autosampler into the HumaCount 5L until the clamps are locked.
2.1.2.6 Connecting the reagents The analyzer operates with

If it was not done beforehand than: chemically and biologically
- Connect the reagent tubes to the HumaCount 5L: active reagents. Direct (skin)
- Remove the safety caps (white) from the reagent connectors on the contact with these reagents
back of the analyzer; should be avoided. Please read re-
- Use the supplied connecting tubes and special bottle caps; agent descriptions carefully for
- Be sure that the color on each tube, cap and connector in the back of possible emergency actions. Only
the instrument match. original reagents are usable with
- Connect the reagent containers to the reagent tubes. HumaCount 5L, available from
HUMAN GmbH.
2.1.2.7 Powering up the HumaCount 5L Place the reagent containers
To power up the HumaCount 5L perform the following steps: near the instrument, to an ac-
- Be sure that the main switch (right next to the power connector) is in off cessible location. Do not place the
position. containers to a higher position
- Be sure that the power switch of the Autosampler unit (if present) is in off than HumaCount 5L. This is to
position; avoid unintentional spilling of re-
- Connect the HumaCount 5L to the wall-outlet using the delivered cord; agents.
- Power up the HumaCount 5L see chapter 3.1.1.2 for details:
- Check if all the software components start up without any problem;
- Check the serial number and the software revision (service level
function).
- Shut down the HumaCount 5L for details see chapter 3.1 .
At this stage do not perform any other operations, just ensure that the Huma-
Count 5L is operational.
18
The Windows XP operating 2.1.2.8 Connecting the peripherals

system is configured to strict - To connect the desired peripherals perform the following steps:
task control on the HumaCount - Shut down the HumaCount 5L for details see chapter 3.1;
5L. Some of the device installa- - Connect the desired peripherals;
tions require to start-up - Power up the HumaCount 5L see chapter 3.1.1.2 for details;
additional tasks. A service action - Install the peripherals:
is required to enable to run addi- - The embedded Windows XP recognizes most of the peripherals
tional tasks. without any additional installation process;
- If your device requires any additional installation steps, then service level
If a peripheral device is direct- actions required;
ly connected to the Huma- - In case of prime installation let the service personnel already present
Count 5L (USB, serial port) and to perform the installation;
has its own power supply than - In case of later installation please ask for service support;
use the same ground-point! (Use - Shut down the HumaCount 5L for details see chapter 3.1.
the same wall-socket group.)
Contact an electrician if you dou-
bts about the quality of the 2.1.3 FIRST STARTUP
grounding. Make sure that the reagents are connected and the tubes are not kinked or
blocked (visual inspection of lines). Also check that the power cord is securely
plugged into the back of the analyzer and into the wall outlet. Flip the small
switch near the power cord (power supply) on the back of the analyzer to the I
position.
Facing the analyzer, flip the switch in the rear, upper-left corner of the unit.
(Stand by switch see chapter 2.2.6.2).
The computer inside the HumaCount 5L needs a few minutes to start up and
initialize the operating software.
HumaCount 5L software starts automatically and puts you in the main menu.
This menu allows access to instrument setup, and you can also start operation.
First startup is special, because HumaCount 5L arrives to your laboratory drained,
without reagents. To avoid warning messages about missing reagents, you have
to fill-up the analyzer with reagents.
Although your HumaCount 5L was quality checked and calibrated at
HUMAN GmbH premises it is necessary to check the reagent level and fill up the
measurement account for the locked reagent system.(see chapter 4.14)

Select the main menu then the Diagnostics function. In the Diagnostics menu
choose the Reagent status option.
FIGURE 4
On the Reagent status panel choose the function All and confirm the reagent
replacement.
FIGURE 5
20
If the total volumes dont match with the volumes of reagent containers you use,
then you can adjust the volumes in the Main menu/ Settings/ System menu. See
details in chapter 4.9.
After performing the reagent fill-up procedure the estimated reagent status (4 icons
at the bottom-left corner of the screen) displays full reagent containers and empty
waste container.
In order to fill up the HumaCount 5L with reagents select the Fill function in the
Main menu/ Maintenance menu. After selecting the Fill function, you need to con-
firm the operation.
FIGURE 6
FIGURE 7
As the process starts the Start button on the front cover changes its color to red,
marking that the pneumatics is busy.
Upon completion of the Fill procedure, the analyzer is ready for operation.
2.1.3.1 Waking up the Autosampler

If the optional Autosampler device is installed as well then check the operability of
the Autosampler. Perform the following steps:
- Power up the Autosampler using the power switch close to the status LED-s;
- Close the cover of the Autosampler, check if the Cover LED changes to green;
- Check the operability of the Autosampler by using the control tool.
Open the control tool by double clicking/ tapping on the Autosampler (AS) status-
report in the bottom-left corner of the screen.

Click/ tap on the Reset button. The Autosampler should check the all the
motor movements and move the motors into home position. You should
receive the home message including the software revision number.
(The power-onmessage contains the serial number of the Autosampler.)
Close the panel using the OK button.
See details about the Autosampler operations in chapter 3.2.3.7.
FIGURE 8
22
2.1.4 PRIMARY SETTINGS

After filling the HumaCount 5L it is time to go through the Settings menu.
It is suggested to adjust the:
- Date and time;

- Language;
- On screen-keyboard;
- Laboratory header;
- The used units;
- Printers.
FIGURE 9
2.1.4.1 Setting Date and Time

Unlike other settings the date/time is adjustable directly by double clicking/
tapping on the displayed time in the bottom-right corner of the screen.

FIGURE 10
Adjust the time if necessary and accept the new value by tapping/ clicking the
"OK button.
See details about date and time in chapter 4.13.
2.1.4.2 Using the Settings Menu

The settings menu allows modifying operation parameters.
Any change must be confirmed by the Save button changes will only take
effect after saving your changes.
FIGURE 11
24
On the Main menu/ Settings/ Customize panel:

- You can select the look of the user interface; select from various available
color schemes
- Adjust the language; Upon accepting the change, the system will change
language no restart needed.
- Chose if you want to use the on-screen keyboard. Uncheck this option only if
you have an external keyboard connected;
- Select which data should be used as main parameter for identifying results
- Patient ID, Name, SSN (social security number)
- You can enable Demo mode: the analyzer will not perform any pneumatic
action
On the Main menu/ Settings/Laboratory panel:

- Enter the Laboratory header. This header will be used on the printed
measurement-reports
- You have 8 lines available. Each line can hold 42 characters
On the Main menu/ Settings/External Devices panel:

- Communication speed on selected port
- Automatic LIS if checked, the analyzer will automatically transmit results
when ready
- LIS Serial port / Ethernet based communication
- if DISABLED all data will be transmitted through the RS232 port using
ASCII protocol
- if ENABLED all data will be transmitted on the Ethernet connection using
HL7 protocol
- Server data for HL7 (Ethernet) protocol must be set, consult the LIS system
administrator for settings
On the Main menu/ Settings/System panel: you can specify system-

dependent options: volume of reagent containers, displayed database columns,
etc
On the Main menu/ Settings/ Units panel adjust the units most suitable for
you for the HGB, cell-count unit and the PCT/HCT parameters.
On the Main menu/ Settings/ Units panel select the printer you want to use
and adjust the printer parameters. To accept the changes you made on any of
the Settings screens, tap/ click the SAVE button. Applying changes can take`
several seconds.
See details about the settings in chapter 4.5.

2.1.4.3 Adjusting the normal Ranges

The HumaCount 5L uses 6 types of sample modes also called profiles: Human
(general profile), Male, Female, Toddler, Child, Baby. Each sample has
an associated profile or mode. The sample-mode (profile) can be adjusted
before the measurement starts. The selected mode/ profile does not influence
the measurement procedure (timings, amount of reagent etc), but selects the
appropriate table of good values. When the HumaCount 5L reports the results
of a measurement the actual values are compared against the good values.
Any out of range cases will be marked on the result-sheets.
The HumaCount 5L has default, generally acceptable values. Based on the
expected patient population you can ask the service personnel to adjust the
normal ranges. (As an example: the altitude from the sea-level can influence
the hematology parameters of the local population.) The change of the normal
ranges requires service level action. Dont forget to adjust these ranges before
the service personnel leaves the site
2.1.5 HOW TO PROCEED

To initiate the daily routine, perform a blank measurement to check the
cleanliness of the system. However maximum precaution and quality measures
are taken in the factory, transportation and packaging material can cause minor
contaminations in the tubing. Therefore it is absolutely normal that 5-10 initial
blank measurements have to be performed to rinse the tubing.
At this point it is a good practice:
- Perform a blank measurement, see chapter 3.1.1.5 for details;
- Perform 4-5 measurements with real blood samples to be familiar with the
instrument, see chapter 3.2.2 for details;
- Perform a calibration while the service personnel still on-site, see chapter 4.3
for details;
- Perform a QC measurement while the service personnel still on-site, see
chapter 3.4 for details.
26
2.1.6 ACCESSORIES
TABLE 1 HumaCount 5L Hematology Analyzer 1 16430
User Manual 1 16430/1
Reagent tubing kit 1 16430/21
Diluent tube (green) 1
Diff tube (orange) 1
Lyse tube (yellow) 1
Waste tube (red) 2
Cleaning tube kit 1
Caps for reagent containers
1
(matching connectors colors)
Waste container (20 L) 1
Sample tube for Hard cleaning 1 18999
Power cable 1 16350/304
Sample tube adapter 1 16350/304
2.2 The HumaCount 5L
2.2.1 GENERAL DESCRIPTION

The HumaCount 5L is a fully automated high quality hematology analy-
zer for in vitro diagnostic use in clinical laboratories. It provides precise and
accurate 5-part differential measure with laser based optical measuring
technology. It implements the Coulter method for WBC, RBC, PLT and measures
the hemoglobin content of red blood cells and with optical measuring head,
light scattering five-part differentiation (LYM, MON, NEU, EOS, BAS).
The analyzer features an 800 x 600 color touch screen LCD display
module and a START button. Instrument software allows sending results to an
external printer Via USB port (Widows XP printer driver required the driver CD
is provided by the printers manufacturer) HumaCount 5L internal memory is
capable of storing 100.000 records including flags, scatter- and histograms. QC
measurements are also stored in separate database. The software operating the
instrument is easy to upgrade using a USB memory device.
The analyzer can be upgraded with an automatic sample loader, sold separately

2.2.2 TECHNICAL DATA

Main unit
TABLE 2
Sample volume Closed-, and Open-mode: 110 l
Sample type Human whole blood (K3-EDTA anticoagulant)
By means of the front panel keyboard (enter ID)

Tube Identification
By means of the barcode labels (manual and/or auto-sampler)
Sampling method Ceramic shear valve with 3 separated primary loops
CBC+5DIFF mode (22 parameters):

WBC, LYM, MON, NEU, EOS, BAS, LYM%, MON%, NEU%, EOS%,
Measured parameters BAS%
RBC, HCT, MCV, RDW, HGB, MCH, MCHC
PLT, PCT, MPV, PDW
Throughput 60 tests/hour
Volumetric impedance change for WBC, RBC, PLT
Spectrophotometry for HGB
Measurement method
Light scattering 4-diff measurement: LYM, MON, NEU, EOS
Light scattering BASO measurement
Aperture diameter WBC: 80 m, RBC/PLT: 70 m
Light source: green LED with 540 nm wavelength
HGB measurement
Detector: light to frequency converter
Light source: semiconductor laser diode with 650 nm wavelength
Optical measurement and 10mW (Class IIIB laser module if the protective housing is
closed)
Quartz flow cell with hydro-dynamic focusing
Detector: fiber optic coupled PIN Si photodiodes
Internal safety interlock
Optional. Horizontal and vertical calibration of laser beam path.
Coarse calibration: with blood
Auto-alignment system
Fine calibration: with calibration material (Polystyrene
micro-particleor Polystyrene microsphere, 7m)
HC 5L Diluent (20 liter)
Reagents HC 5L Lyse (5 liter)
HC 5L Diff (1 liter)
WBC/BAS 1: 228
Dilution ratios RBC/PLT 1: 32.000
4 DIFF 1: 250
Sheath fluid Diluent
28
Control material
16- and 64-day Levey-Jennings charts, separate QC database
Quality Control
(6 Level)
Pathological (diagnostic) flags
Lab limits (normal ranges)
Flagging Reagents alert (3 measurement prealert-online reagent
replacement)
Instrument alerts, internal buffer for reagents
Calibration Manual and SW supported automatic mode
Languages available English menu and support for other languages
Software upgrade Via USB
Data storage capacity 100.000 records including flags, scatter- and histograms
Data processing VIA C7 1.8 GHz processor
Data store Embedded XP
Display 800 x 600 color graphic LCD, portrait layout
External printing Via USB port, any Windows compatible printer
External keyboard Via PS/2 or USB
Optional Manual bar-code reader via USB
Bar-Code reader
Built-in in the Auto-sampler
Peripheral ports USB (2.0) 4pc., Ethernet, PS/2
Power supply input: 110/230 VAC; 47Hz to 63Hz
Power requirements
Power Consumption: maximum 400 VA
Main fuse F 10A H 250V
Dimension Instrument without any compoments: 54 x 46 x 45 cm
Space required for routine use: 120 x 60 x 100 cm
Packaging: 56 x 52 x 54 cm
Gross weight: 21,5 kg, Net: 21 kg
Operating temperature 15-30 C (59-98 F); Maximum relative humidity 80%
2.2.3 MEASURED PARAMETERS

HumaCount 5L determines 24 hematology parameters including 5-part WBC differential. The
instrument requires 100 l of whole blood-samples in Closed- and Open-mode. Cycle time is
60 seconds.
White Blood Cells WBC Number of leukocytes
TABLE 3 (cells/l, cells/l) WBC = WBCcal x (cells/l, cells/l)
Red Blood Cells RBC Number of erythrocytes
(cells/l, cells/l) RBC = RBCcal x (cells/l, cells/l)
Hemoglobin concentration - HGB Measured photometrically at 540 nm; in each cycle
blank measurement is performed on diluent
(g/dl, g/l, mmol/l) HGB = HGBcal x (HGBmeasured HGBblank)

Mean Corpuscular Volume - MCV Average volume of individual erythrocytes derived

(fl) from the RBC histogram.
Hematocrit HCT Calculated from the RBC and MCV values.
HCTpercentage = RBC x MCV x 100
(percentage, absolute) HCTabsolute = RBC x MCV
Mean Corpuscular Hemoglobin MCH Average hemoglobin content of erythrocytes, calcu-
(pg, fmol) lated from RBC and HGB values.
MCH = HGB / RBC
Mean Corpuscular Hemoglobin Calculated from the HGB and HCT values.
Concentration MCHC MCHC = HGB / HCTabsolute
Unit of measurement is displayed according to the
(g/dl, g/l, mmol/l) one chosen for HGB result (g/dl, g/l or mmol/l)
Red Cell Distribution Width RDW-SD (fl) The distribution width of the erythrocyte or
Platelet Distribution Width PDW-SD (fl) platelet population derived from the histogram at
20% of peak
Red cell Distribution Width RDW-CV
(absolute)
Platelet Distribution 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/l) PLT = PLTcal x (cells/l, cells/l)
Mean Platelet Volume MPV Average volume of individual platelets derived from
(fl) the PLT histogram
Thrombocrit PCT Calculated from the PLT and MPV values
PCTpercentage = PLT x MPV x 100
(percentage, absolute) PCTabsolute = PLT x MPV
White blood cell, 4 part differential: Relative value are calculated from the optical 4 diff
LYM (%) : lymphocytes scatter populations
MON (%) : monocytes and some
eosinophils
NEU (%) : neutrophil granulocytes
EOS(%):eosinophil granulocytes
BAS (%):basophil granulocytes Relative value is calculated from the basofil optical
scatter populations
30
TABLE 4 Range Display Range Display Range Display

Reported results value "---"
WBC [103/l] 0...100 value 100...120 120...+
and linearity flags AND "*" AND "0"
value "---"
RBC [106/l] 0...8.0 value 8.0...9.6 9.6...+
AND "*" AND "0"
value "---"
HGB [g/l] 0...250 value 250...300 300...+
AND "*" AND "0"
value "---"
PLT [103/l] 0...800 value 800...1200 1200...+
AND "*" AND "0"
2.2.4 REAGENT AND CONTROL MATERIALS

If the eyes or skin come into Always use reagents and control materials recommended and approved by the
contact with any of the rea- manufacturer. The analyzer, the control material and the reagents form a sy-
gents, flush abundantly with wa- stem. Each component of this system is carefully selected and designed to meet
ter. If a large quantity is ingested, certain criteria, which can very sensitively indicate and validate system operati-
drink water immediately and on. Using non-approved components of this system can cause false indications
contact with a doctor. or incorrect, inaccurate measurements.
2.2.4.1 Reagents
In order to operate correctly and accurately the following reagents must be used.
All these reagents are manufactured and provided by HUMAN GmbH.
All these reagents are for in vitro use only!
2.2.4.2 HC5L Diluent
Description Multiple ultra-filtered, particle free buffered iso-

TABLE 5
tonic solution, containing stabilizers, special ad-
ditives and preservatives.
Application Quantitative and qualitative determination of
RBC, WBC, PLT and HGB concentration.
Appearance Colorless, odorless solution.
Shelf-life 36 months
Open bottle stability 120 days
Storage Between +15 C and +30 C. (~59-86F)
HUMAN GmbH 16430/40, 20 liters
reagent code
Color code Green

2.2.4.3 HC5L-Lyse
Description Multiple ultra-filtered, particle free reagent so- TABLE 6
lution, containing lysing detergents, stabilizers,
leucoprotective components, special additives
and preservatives.
Application Quantitative and qualitative determination of
RBC, WBC, PLT and HGB concentration.
Appearance Colorless solution, foaming by shaking.
Storage Between +15 C and +30C. (~59-86F)
HUMAN GmbH 16430/30, 5 liters
reagent code
Color code Yellow
The product is environmental-friendly, since does not contain azide nor cyanide.
2.2.4.4 HC5L Diff
Description Multiple ultra-filtered, particle free reagent solution, TABLE 7

containing stabilizers, leucoprotective components,
special additives and preservatives.
Application Quantitative determination of WBC, leukocyte five-part
diffrentiation (LYM, MON, NEU, EOS, BAS) and hemoglobin
(HGB) concentration.
Appearance Colorless, odorless solution.
Storage Between +15C and +30C. (~59-86F)
HUMAN GmbH 16430/40, 1liter
reagent code
Color code Orange
2.2.4.5 Control Material

At the date this user-manual was written the following control material was
tested together with the HumaCount 5L and was approved for use [REF] 3838.
2.2.5 MEASUREMENT PRINCIPLES

HumaCount 5L uses combined methods to provide hematology reports.
Volumetric impedance method is used to determine cell counts regarding WBC
RBC and PLT parameters.
32
Photometric measurement of light absorbance is used to determine hemo-

globin (HGB) concentration.
Optical measurement of light scattering and diffraction is used to determine
5 part WBC parameters by means of a special component.
2.2.5.1 Impedance Method

The volumetric impedance method (a.c.a. Coulter method) counts and sizes cells
by detecting and measuring changes in electrical impedance, when a particle
within a conductive liquid passes through a small aperture.
FIGURE 12
Impedance Method
Internal electrode
+ Aperture
Blood cell suspension
External electrode
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 is proportional to the number of particles. The
intensity of each pulse is proportional to the volume of that particle. The volume
distribution diagrams of the particles are WBC, RBC, and PLT histograms. Pulses
are counted only in channels (in terms of femtoliter, fl), which are between the
lower and upper discriminators.
2.2.5.2 Principle of HGB Measurement

The lysed sample dilution can be analyzed for HGB based on stable chromogen
content. The reagent lyses the red blood cells, which release hemoglobin.
Subsequently, the HGB concentration is measured in a photometrical way
across the WBC chamber. The actual sample HGB calculated as a difference of a

blank and a bloody measure with and without illumination to reduce the effect
of liquid refraction and disturbing light.
FIGURE 13
2.2.5.3 Principle of Optical Measurement

Optical measurement of light scattering and diffraction is used to determine
5 part WBC parameters. The optical measuring head contains focused laser
source to illuminate the stream of WBC blood cells. The intensity changes of the
scattered laser light, coming from the cells, determined by the cell volume and
structure. The changes recorded as an increase in the voltage of the detector
system outputs.
The number of pulses is proportional to the number of particles. The intensity
of each pulse is proportional to the volume and granularity of the blood cells.
The WBC 5 population separation is based on the two dimension volume and
granularity distribution diagram.
FIGURE 14
The intensity of scattered light is detected by an optical signal processing

system. Light beamed onto a cell will diffract (scatter) depending on the cells
internal and external structures.
34
External structure (and the size of the cell) causes low angle scatter.
Internal complexity causes high angle diffraction. The different angled lights
are captured by optical sensors. Thus the system gets two independent parame-
ters about one cell passing the light beam.
FIGURE 15
The data are plotted in a 2 dimensional coordinate system. Similar cells have
similar scatter characteristics, and the analytical software can separate
differentiate and identify them to provide 4DIFF and BASO scatter diagrams.
FIGURE 16

2.2.6 IDENTIFYING PARTS OF THE ANALYZER
2.2.6.1 Front panel
FIGURE 17
1
1 Touch screen
2 Front panel
3 Sample rotor
4 START button
4
2 3
1. Touch screen
This is the main user interface of HumaCount 5L. User interactions and data
input happen using this screen. The screen is cleanable by a sponge and
ethanol 70%.
2. Front panel
This is the cover of the main fluidic element like shear valve, sampling needle,
syringes. It can be easilIdentifyingy opened if any maintenance is necessary. The
front panel is cleanable by damp sponge and ethanol 70% or antibacterial soap.
3. Sample rotor
The needle takes manual sample from the tube inserted in the sample
holder of the sample rotor. The sample rotor turns into the HumaCount 5L and
cover the sample needle from the unintended touch. The different sample tube
types need different sample holder types for proper sampling. The Sample rotor
is cleanable by damp sponge and ethanol 70% or antibacterial soap.
In case of automated (Autosampler based) measurements the emergency/
urgent samples are processed from the sample-rotor.
36
4. START button
This is easy way to start the manual/ emergency measurement to push the
start button in the front panel. The sample and patient data are settable in the
touch screen. The color of the START button identifies the status of the Huma-
Count 5L. The green color means HumaCount 5L is ready to measure. The red
color means HumaCount 5L is engaged in measurement. The orange color means
HumaCount 5L is in the stand by state or performing automated maintenance
like operations. Clean the START button with a damp cloth and ethanol (70%) or
standard cleaning solution.
2.2.6.2 Rear Panel (electrical connections)

FIGURE 18
1 Stand by button
2 Hardware Key (HK) 3
connector
3 Main board Back
Panel I /O Ports
4 Power connector
5
5 Reagent connector
4 6
6 Power switch
1. Stand by button
This button wakes Rearup the HumaCount 5L main board and power on all the
components inside the HumaCount 5L or stand by the main board and power
Power supply input: off the components after the daily activities.
110/230VAC ; 47Hz to
63Hz Power Consumption: 2. Hardware Key (HK) connector
maximum 400 VA This connector is used to connect the Hardware Keys (HK) in case of locked
reagent system. See details in chapter 4.14.
3. Main board Back Panel I/O Ports

These connectors are part of the HumaCount 5L main board, and represent
standard connection options of a computer to various peripherals.

4. Power connector
The HumaCount 5L should be connected to a safety grounded socket near to the
analyzer by a power cord of the HumaCount 5L. If there is any malfunction or
risk for failure witch effect the soundness of human or risk for electrical sock or
fire, please promptly disconnect the power cord from the socket outlet.
5. Reagent connectors
The color coded inlets provide connection to the reagent system. The connectors
have a safety groove to offer a secure connection with the analyzer.
6. Power switch
This is the main power switch of the HumaCount 5L.
If the power switch is on the HumaCount 5L is in the Stand by state and to be
able to wake up by the Stand by button.
If it is off the HumaCount 5L powered off.
FIGURE 19
- 1 x PS2 Mouse port to connect optional mouse

- 1 x PS2 Keyboard to connect optional keyboard
- 1 x Serial port - to connect the hospital data collection system (HUMAN
GmbH 3.1 protocol)
- 2 x RJ45 LAN port to connect the hospital data collection system
(HL7 protocol)
- 1 x VGA port optional VGA monitor connection for service purposes only
- 4 x USB 2.0 ports to connect printer
- 3 x Audio jacks: Line-out, Line-in and MIC-in (Horizontal, Smart
5.1 supported) not used.
Avoid liquids getting on the electrical connectors. The rear panel of the analyzer
should be cleaned with a cloth or sponge with ethanol.
38
2.2.6.3 Computing entities

The HumaCount 5L has the following computing entities:
- The physical controller. This device is also referred as the LS-DACQ or COMB
card. This part is responsible for the low-level operations. (Like turning the
sample door.);
- The Dimm-PC. The Dimm-PC is the controller of low-level operations and
converts the physical signals to values usable for hematology calculations;
- The Dimm-PC and the LS-DACQ unit together also referred as the lower part
of the system;
- The controller of the laser unit;
- The application running on the built-in PC, it is also referred as the upper
part. This is the main processing and control unit on the HumaCount 5L.
- The controller of the Autosampler.
2.2.6.4 Left side assembly

To access left and right side structures, side panels have to be removed. Please
refer to 3.4.3 for instructions.
FIGURE 20
1
1 Pressure sensor
5
2 Measure buffer small
3 Sheath buffer
4 Lyse-5P
5 Mix, RBC, WBC 6
chambers
6 Valves 1-22
7 Valves 23-44
8 Diluent buffers 7
2 8

- Pressure sensors measure the differential pressures of vacuum buffers for

impedance base and optical measurement and empty chamber process.
- Measure buffer small is a vacuum buffer for impedance measurement.
- Sheath buffer is a diluents tank for the optical measures
- Stop buffer is an internal tank to store HC5L-Diff reagent
- Lyse buffer is an internal tank to store HC5L-Lyse reagent
- Diluent buffers are inner tanks to store HC5L-Diluent reagent
- Valves 1-44 are special valves to connect syringes, chambers, buffers, etc. to
form required liquid system
- Mix chamber performs the first step of RBC dilution.
- RBC chamber performs the second step of RBC dilution and holds the RBC
aperture
- WBC chamber performs the WBC dilution and holds the WBC aperture
2.2.7 RIGHT SIDE ASSEMBLY

With side panel removed.
FIGURE 21
1 Aspirating needle
5
2 Horizontal and vertikal
motion unit
3 Washing head
4 Sample rotor
5 Optical head
6 Power supply
1
7 Auto sampler unit
connector
7
40
- Aspirating tip takes blood sample during the normal or emergency sampling
process
- Horizontal and vertical moving unit is positioning and moving the sample
needle
- Washing head cleans the outer surface of the aspirating tip
- Sample rotor holds the blood sample and rotates it into emergency position
- Auto sampler connector is the power and control connector of the auto
sampler
- Optical head contain laser source and detectors optical elements and auto
alignment for the optical measurement
2.2.7.1 Front assembly

With front panel open
FIGURE 22
1 Shear valve
2 Syringes
3 Aspirating needle
1
4 Sample rotor
3
The shear-valve has un-con-

nected loops, protected by
back-connected short tubing.
These loops are reserved for futu-
2 4
re development. Do not remove
the protective tubing!
- Syringes establish controlled volume and speed streams of reagents

- Shear valve is an integrated multi functional valve

2.3 User Interface

The user interface of the HumaCount 5L is designed for simple and straight-for-
ward operation. All the user level functions are reachable by using the standard
interface elements only. You can interact with the HumaCount 5L by using the
following devices:
- The touch-screen;
- The physical Start button;
- External keyboard (PS2 or USB) : optional device;
- External mouse (PS2 or USB): optional device.
Although we presume that you have some basic experience about computers
and / or other electronic gadgets, still even the basic issues are described in the
chapters below.
2.3.1 USING THE TOUCH SCREEN

The touch screen is a pressure sensitive device on the top of the screen of the
HumaCount 5L. You can activate the different menu-items, buttons by gently Do not use sharp or heavy ob-
pressing the surface over the selected item. This method is called tapping. jects to operate the touch
The touch-screen device used in the HumaCount 5L instrument is screen. The surface material is
selected for reliability, endurance and compatibility with medical, laboratory moderately resistive to liquids.
environment. Simple operations are supported, but multi-touch gestures or Avoid touching the screen with
multiple tapping are not supported. wet fingers, or to let liquids get in
The touchable items on the HumaCount 5L user interface are designed to contact with the screen or the
be big enough to tap with finger. However in some cases (wearing gloves surrounding area.
specially if the gloves oversized, having thicker than the average fingers, you
want to type fast) you may find the usage of a tapping tool useful.
You may use:

- the blunt-end of a pen, pencil;
- the round bottom of a sample-tube (supposed that the sample-tube is clean
and dry);
- a plastic stylus used with PDA devices
as a tapping tool.
If you find that your tapping actions and the response of the HumaCount 5L
does not match then please re-calibrate the touch-screen before asking for
service/ support. See details in chapter 5.2.3.
42
2.3.2 USING THE START-BUTTON

The Start button is a fixed purpose button on the front cover of the Huma-
Count 5L. This button has 2 functions:
- Provide feed-back about the status of the measurement system:
- The green color means that the HumaCount 5L is ready to start a new
measurement;
- The red color means that the measuring system a.k.a. the pneumatics is
busy (like measurement in progress);
- The orange color means that the pneumatics performing an automatic
operation, or the pneumatics is in standby mode;
- Start measurement from the sample rotor (manual samples or urgent/
emergency samples during automated measurements).
2.3.3 USING EXTERNAL MOUSE

Using an external (PS2/ USB) mouse you can use the same functions as using
the touch screen. By moving the mouse, navigate the mouse pointer over the
desired item. Instead of tapping the touch-screen press the LEFT mouse button
to activate the function. This procedure is referenced as clicking (click) an item.
The external mouse and the touch-pad can be used parallel.
The mouse-pointer can be moved out from the visible screen-area. If you cant
see the mouse-pointer then please move it upwards to navigate it back to the
viewable area.
2.3.4 USING EXTERNAL KEYBOARD

Using an external (PS2/ USB) keyboard you can use the same functions as using
the touch screen based virtual key-pads. As general experience most of the users
can achieve higher typing speed on an external key-board.
Based on the Settings/ Customize/ On screen keyboard active check-box a
virtual key-pad is activated on the screen if a type-in field (name, sample ID,
target value etc.) is activated (clicking/ tapping).
The virtual key-pads are tailored to the connected type-in filed. If only nume-
ric values are accepted than a numeric-only keypad pops up, for dates a date
selection keypad pops up etc.
If you wish to use the external key-board then:
- Unselect the Settings/ Customize/ On screen keyboard active check-box
or;
- Deactivate the pop-up key-pad by:
- Pressing the ESC button on the key-board or
- Clicking / tapping the Cancel button on the virtual key-pad.

2.3.5 USING THE VIRTUAL KEY-PADS

The graphical user-interface contains virtual key-pads to type-in the required
values. The following key-pads are available:
- Numeric only;
- Date;
- Alpha-numeric with shift and symbol options.
As it mentioned earlier for robustness reasons the touch-pad of the HumaCount
5L handles single taps only. Therefore the shift/ symbol options are sticky on
the virtual key-boards. (Like the caps-lock a PC key-board.)
Click/ tap on the desired button to type in the required value. Complete the
operation by clicking/ taping the OK / Done buttons.
FIGURE 23
FIGURE 24
FIGURE 25
44
FIGURE 26
FIGURE 27
2.3.6 USING THE GUI

The graphical user interface (GUI) of the HumaCount 5L can be divided into
3 main sections:
1. Quick links to main functions (upper part);

2. Interactive display area (middle section);
3. Status display (bottom section).

1 FIGURE 28
2.3.6.1 The Quick links 1

The upper part of the GUI is visible during all operations. The actually selected
quick link / permanent button is framed from 3 sides. The quick link connected to
The actual content of the interactive display area is pre-selected by the quick the Autosampler (AS)
links. functions is disabled if the
Autosampler device is not
2.3.6.2 The middle section 2 connected
The middle section is used to display function or menu specific information,
results, and all the dialogs that contain relevant information to the active
operation mode.
2.3.6.3 The status display 3

The bottom section displays the
- Status of the Autosampler unit;
- Estimated fullness of the reagent and waste containers;
- The occurrent error/ warning icons (like running out of reagent, missing
bar-code information);
46
- The status / active operation of the pneumatics (standby, manual measure,

rinse, clean);
- The progress of the active operation of the pneumatics;
- The actual time.
By tapping / clicking on the error/ warning icon you can make a short-cut to the
relevant menu where you can fix the problem or get information/ help how to
resolve the problem.
FIGURE 29
2.3.6.4 Scrolling and selection

Some cases the screen cannot hold all the information, and you will have to
scroll around to see more data.
- You can scroll the displayed area (1):

Use the small bar on the scrollbar to see more data. If you use the touch-screen
then tap and hold the scrollbar with the tip of your finger, and gently pull
toward the direction of scrolling. If you use an external mouse than move the
mouse-pointer over the scroll-bar pres and hold-down the LEFT mouse button
and scroll to the desired position.
- You can roll the list page by page (2)
Click/ tap on the page-up/ page-down scroll-control button in order to move the
list 1 display-are forward or backward.
- You can jump to the 1st or the last item on the list (3):
Click/ tap on the 1st/ last button on scroll-control (vertical/ horizontal) to jump
to the 1st/ last item.
- You can roll the list line by line (column by column) (4):
Click/ tap on the line/column forward/ backward button on the scroll control.

FIGURE 30
2.3.6.5 Multi-select
To select multiple rows or data, you will have to enable the multi-select option.
Below the list there can be a Multiselect checkbox. Tap/ click the rectangle
(an X will indicate active state). Now tapping an entry will change its state of
selection.
48
FIGURE 31
2.3.6.6 Entering values

In order to enter values into a data-field simply click/ tap on it. The data-filed
changes to yellow marking the active data-field. Enter the desired values using
the external keyboard or the on-screen virtual keypad. If the entered value is out
the specified range then the color of the data-filed will change to red.
2.3.7 THE MENU SYSTEM

The graphical user interface of the HumaCount 5L analyzer has primary func-
tions that are accessible directly by means of icons or controls that are always
available to the operator. The HumaCount 5L analyzer also has secondary func-
tions that are available via two or more taps or clicks through the menu struc-
ture, or menu tree.

2.3.7.1 Starting a Manual Single Tube Measurement

Tapping or clicking on the Measure icon with the single sample tube graphic
allows access to the following functions:
- Initiate a primary blank measurement
- Make adjustments and settings about the manual measurement:
o Enter the Sample ID (unique or auto-increment)
o Select the associated patient
o Select the sample type or patient mode
- Start a manual measurement
- View the measurements results in detail:
o View the measured parameters
o View the calculated parameters
o View parameters that are out of the normal range
o View error, warning, or clinical flags
See chapter 7.3 for more information about manual measurements.
2.3.7.2 Start Automated Measurements

Tapping or clicking the AS icon with the multiple sample tube graphic allows
access to the following functions:
- Initiate automated measurements in one of three modes:
o Full scan mode
o Free list mode
o Selected samples mode
- Define sample parameters (the parameter list depends which one of the
three sample modes are selected)
- Monitor the progress of the automated measurements
- View the details completed measurements
See chapter 7.3 for more information about automated measurements.
2.3.7.3 Access the Database

Tapping or clicking the Database icon with the file cabinet graphic allows ac-
cess to the following functions:
- Select completed and measurement stored as database records
- Export database records for storage or import results for viewing
- Delete database records
- Send database records to the LIS
- Review the details of selected measurements
See chapter 4 for more information about accessing and using the Huma-
Count 5L database.
50
2.3.7.4 Main Menu

Tapping or clicking the Menu icon with the main menu graphic displays and al-
lows access to the main menu. The main menu is automatically displayed when
the HumaCount 5L analyzer is started up. The main menu icons are arranged in
an intuitive and attractive circular design.
FIGURE 32
HumaCount 5L Main Menu
2.3.7.5 Autosampler Control Panel

If you have an optional Autosampler installed, the Autosampler control panel
can be opened by double clicking/tapping the Autosampler status on the left
side of the status display on the bottom of the screen. The Autosampler control
panel allows you to see of the Autosampler is operational and perform an Au-
tosampler initialization.
See chapter 3.2.4.2 for more information about the Autosampler control panel.
2.3.7.6 Adjust the Time and Date

Double click/tap the time display on the right side of the status display on the
bottom of the screen to bring up a panel for adjusting the stored time and date
of the HumaCount 5L analyzer. See chapter 2.1.4.1 for more information about
time and date adjustment.

2.3.7.7 Open the Warning Panelr

If an error or warning is currently active, an exclamation point icon appears on
the status display. Click the icon to review the active error or warning and jump
to the appropriate menu where the error or warning can be addressed (such as
reagent replacement).
2.3.7.8 Menu tree

The following is a listing of the HumaCount 5L analyzer main menu tree:
Patient TABLE 8
New: Add a new patient
HumaCount 5L Analyzer
Edit: Modify an individual patients information
Menu Tree
Details: View an individual patients information
See chapter 4.4 for more information about patient data
Exit
Cancel: Cancels shutdown of the HumaCount 5L analyzer
Prepare for shipment: Performs an extensive drain procedure of the Huma-
Count 5L pneumatic system in preparation for shipment or an extended period
of inactivity
Log off: Logs off the current user session
Shutdown: Prepares the HumaCount 5L for a complete shutdown
Settings
Customize
Language: Change the active language
Limit Style: View parameter normal range status in numerical or graphical
format
Sound Volume: Change the volume of the HumaCount 5L built-in speaker
On screen keyboard active: Turn off on-screen virtual keypads for use with an
optional external keyboard
Patients displayed data: Patient identifier visible in the database display
Laboratory: Eight lines of text of lab information be displayed on each printed
page
External devices
Sending port baud rate: Select transmission rate for serial LIS
Automatic LIS: Select whether to automatically transmit results each time a
sample is processed
LIS: Select Ethernet LIS connection
IP: IP address of Ethernet-based LIS host computer listening port
Port: Port number of Ethernet-based LIS host computer listening port
Bidirectional LIS: Selects whether Autosampler information downloads are
allowed
System
52
Waste container volume: Selects a 10L, 20L, or no waste container (direct to

drain)
Database display limit: Selects all or only last month of database record dis-
play
Use only Sarstedt-Monovette tub from sample rotor: Change sampling adjust-
ments to accommodate Sarstedt Monovette tubes
Standby time: Time period of inactivity before the HumaCount 5L automati-
cally enters standby
Offline rinsing frequency: Time period of inactivity before the HumaCount
5L performs an offline rinse to keep the pneumatic system in peak operating
condition
Screen saver Time period of inactivity before screen saver takes effect
Special flags(G, A, B): Select whether G, A, and B flags are displayed
Units
HGB unit: Selects the units for HGB and HGB-derived or calculated parameters
Count unit: Selects the units for WBC, RBC, and PLT and derived or calculated
parameters
Printer
Printer: Selects which printer to print to
Printer status: Display the currently selected printer status
Color printing: Selects whether to print in color
Double sided printing: Selects whether to print multi-page printouts on both
sides of a page
Items in queue: Number of items in the printer queue
Cancel all jobs: Cancels all items in the selected printers queue
Printout format: Allows selection of printout format (normal or wide parame-
ter names) see chapter 4.5 for details
Automatic print: Selects whether to print for every new sample processed
Logo visible: Selects whether to print or omit graphical logo to printout
Refresh printers list: Refreshes the list of displayed printers
Profile limits: Enter normal ranges for various profile limits
User: Add and manage users of the HumaCount 5L analyzer
See chapter 4.5 for more information about HumaCount 5L analyzer settings
Maintenance
Clean: Perform extended cleaning of various pneumatic components
Internal reagent reservoir: Drain one or all internal reagent reservoirs
Empty chamber: Empty RBC, WBC, and mix chambers
Prime: Prime one or all reagent reservoirs
Fill: Fills the fluidic components of the system with reagents
Touchscreen: Calibrate the touchscreen location for taps and button presses
See chapter 5 for more information about HumaCount 5L maintenance proce-
dures
Calibration
Calibration: Use a calibrator material to calibrate the system

Calibration mode: Select type of calibration procedure to run

Calibration type: Select human blood or calibrator material
Target values: Enter the target ranges for each calibrated parameter
Cancel: Cancels a calibration procedure
Next: Initiates processing of calibration run
View Calibrations: View, delete previous calibrations
See chapter 4.2 for more information about HumaCount 5L calibration
QC
QC Measure: Initiate processing of a control sample
QC Reference select: Select which stored QC reference this measurement
belongs to
Set QC Reference: Create a new stored QC reference
View QC references: Browse stored QC references
View QC data: Browse individual QC sample measurements
View QC diagrams: View Levy-Jennings diagrams of QC data
See chapter 3.4 for more information about quality control on the Huma-
Count 5L analyzer
Diagnostics
Selftest
Load last selftest: Loads the results of the last selftest
Start electronic: Starts the electronic tests
Start both: Starts both electronic and pneumatic tests
Log: Review and obtain additional details about events in the system log
Reagent status: Reset levels for individual reagents and waste (or all) for rea-
gent replacement
Statistics: Provides operating statistics such as cycle counts, errors, etc.
Information: Provides version information for all software items in the Huma-
Count 5L analyzer
2.3.8 SAFETY AND ACCESS CODES

Some functions require password protected confirmation. For example, dele-
ting a record from the database requires entry of a password. The security pass-
word for deleting database entries is: 555.
54

ROUTINE UTILIZATION 55
3 ROUTINE UTILIZATION
In this chapter a typical daily routine is described. Of course your daily routine
can be different than the one described here. This chapter also contains some
trick and trips. We suppose that the laboratory works during office hours only.
The daily routine:

- Power-up, and start-up the HumaCount 5L. See chapter 6.1.1 for derails;
- Perform the pneumatics initialization and the blank measurement as well.
- During the start-up check the reagent levels, start your internal procedure to
get new reagents from the storage if necessary;
- Collect the samples:
- Check if the correct (K3-EDTA) tubes are used;
- Check if the samples are within the 12 hours of processing limit
- Check if the samples are at room-temperature (refrigerated samples);
- Initiate the Autosampler (if installed);
- Perform the QC procedure if scheduled;
- Start the measurements in manual or automated mode. See chapter 7 for
details;
- Check and release the results according to your internal regulations;
- Perform the necessary maintenance actions. See chapter 5 for details;
- Shut down the instrument. See chapter 3.1 for details;
- Clean the instrument. See chapter 4.14.
Notes:
Blank measurements:
- If you want to check if the reagent-path was not contaminated during
the reagent replacement then run 4-5 blanks before accepting the blank
measurement results. The reagents from the internal reservoirs should be
used before the new reagent reaches the measurement system;
- If you receive the samples in batches and more than 2 hours elapsed
between the last sample of the previous batch and the first sample of the
next batch, then it is a good practice to repeat the blank measurement;
QC:
- Perform the QC measurements according to your local regulations;
- Please monitor the expire date and the stability after first use of the QC
material;
- If there are more hematological instruments in your laboratory then it is also
a good practice to measure the same human sample on all the instruments
56
to compare the instruments. Use more parallels to reduce the effect of the
random error (CV%);
- We suggest to perform a blank measurement before the QC measurements;
Calibration:
- Calibrate the HumaCount 5L if the QC results or the comparing to other
instruments shows permanent error in the measurements;
- If you perform a measurement based calibration then we suggest to perform
a blank measurement before the calibration procedure;
- See chapter 4.2
Cleaning: Perform cleaning / hard cleaning if:

- High blank results experienced;
- Clogging related flags systematically added to the measurement results;
- After service actions, service level maintenance;
- The measurement results, QC results are drifting (hard cleaning);
- Plugging in the tubing (first remove the plugging, contamination);
- Reagent connected to wrong place, wrong reagents were used.
3.1 Start-up and shut-down the HumaCount 5L

The HumaCount 5L is a complex instrument with more level of operation. The
start-up procedure has 4 levels.
- Power-up the HumaCount 5L;
- Start up the user interface and the background hardware, software en-
tities. This stage also includes the user-login if the multi-user mode is
activated;
- Start up the measure hardware and software. (The measuring system is also
referenced as the pneumatics);
- The HumaCount 5L is ready to make measurements after an accepted blank
measurement.
The stopping of the HumaCount 5L has the following stages/ options;
- If the multi-user mode is activated then it is possible to change the active
user-account, practically:
- Log off
- Log in.
- Shut down the HumaCount 5L:
- The so called pneumatics will be cleaned, emptied, prepared for the next
start-up if any pneumatics operation was performed;

- The user interface and the background hardware, software

entities stopped.
- Prepare for shipment the HumaCount 5L:
- The HumaCount 5L like the other hematology instruments operates
reagents with high salt-concentration. If the HumaCount 5L is not used
for extended period of time, or the HumaCount 5L is moved to a diffe-
rent location then it is a good practice to remove the reagents from the
instrument to prevent any salt build-up or spilling out the reagents.
- Emergency stopping procedures;
- Powering of the HumaCount 5L.
For details please check the following chapters.
3.1.1 FROM POWER-OFF TO READY TO MEASURE

In the following chapters you will find information about the start-sequence of
the HumaCount 5L.
3.1.1.1 Visual check

While starting up the HumaCount 5L it is suggested to perform the following
steps. Most of these steps are obvious for the first look, but dont forget that
if more persons use the same instrument then the small problems usually left
un-attended.
- Check the reagent tubes by gently pulling on them to make sure that
connections are not loose.
- Open the front cover and check that there is no leakage around the shear
valve or the syringe pumps;
- Check for salt-stains around the HumaCount 5L, the reagent tubing and the
reagent containers. Depending on the light, illumination in some cases it is
easier to notice a white salt-stain than a more or less transparent reagent
spillage;
- Check that the power-cord properly plugged in both into the wall-outlet and
in the HumaCount 5L;
- Empty the waste container if there is a reasonable amount of liquid. After
start up reset the waste level in the Main menu/ Diagnostics/Reagent
status panel.
3.1.1.2 Power up the HumaCount 5L

In order to power-up the HumaCount 5L:
- Turn on the main switch of the electrical network powering the Huma-
Count 5L;
58
- Turn on the power switch of the HumaCount 5L. (Chapter 2.2.6.2);

- Turn on the peripherals (e.g.: printer).
Please note that the HumaCount 5L can be powered-up continuously. If your

local or laboratory regulations require stricter procedures then follow those re-
gulations. (Like separate fuse/ circuit-breaker for each laboratory table, work-
bench, mandatory power-cut after work-hours.)
3.1.1.3 Start up the user interface

To start up the internal user interface computer of the HumaCount 5L analyzer,
flip the standby switch near the top of the rear panel of the HumaCount 5L ana-
lyzer to the up position. The standby switch springs back to the down position
after activation.
FIGURE 33
The following sequence of events takes place after enabling the standby switch:
- The internal computer starts up displaying the EPIA logo in a rotated way.
- The embedded Windows XP operating system starts up. As the display
initializes the screen changes color.
- The HumaCount 5L application software starts up displaying the Huma-
Count 5L logo screen. Individual component start up status is displayed in
the bottom right corner of the logo.
- If the multi-user option is enabled then a user ID and password is required.
- The HumaCount 5L main menu is displayed.
- At this point, the HumaCount 5L analyzer user interface is ready to use, but
the analyzer is not yet ready to measure samples. This requires initialization
of the HumaCount 5L pneumatic system. The following functions are availa-
ble at this time:

- Use the patient database to add and modify entries.

- Review, archive, send to LIS and print existing measurement records.
- Review calibration and QC results and history.
- Change settings.
3.1.1.4 User Login

If the multi-user feature is activated, a user must be logged in before the user
interface of the HumaCount 5L can be accessed. You can log in on two different
ways:
- Enter the user ID and password assigned to your account.
- Create a new user account.
The multi-user feature of the HumaCount 5L analyzer tracks which user is
logged on when important activities are performed such as sample or QC mea-
surements or calibration. The multi-user feature allows full access to admini-
strator users while restricting regular users from actions that change the way
the HumaCount 5L analyzer operates, such as changing calibration settings.
3.1.1.5 Pneumatics Start and Blank measurement

Before measuring any blood or control samples, the pneumatic system compon-
ents of the HumaCount 5L analyzer need to be initialized and a blank measure-
ment run and accepted. To start the pneumatic system and run a blank mea-
surement, click or tap the Measure icon with the single test tube graphic on the
top left corner of the screen. The following sequence takes place:
- The color of the Start button changes to red;

- The reagents are primed;
- The measuring system flushed;
- The sample-door, syringe, needle x/y movement, shear-valve stepper motors
activated, all moving parts go through a movement (homing) test;
- The vacuum-system is activated, the pumps sensors are tested, the vacuum-
drift (leakage)is tested;
- A blank measurement in initiated and performed automatically:
- An empty result screen is displayed;
- The blank measurement is performed;
- The results of the blank measurement are displayed.
The results of a blank measurement must be accepted before blood or control

samples can be processed. If the results from the first blank measurement are
not acceptable, it does not necessarily mean that something is wrong about
your HumaCount 5L analyzer. Please consider the following:
60
- Blood proteins or other particles can accumulate in the pneumatic tubing or

components.
- Although the reagents contain antimicrobial agents, some microbial growth
may still be present.
- An extended period of inactivity without performing a prepare for ship-
ment procedure may result in salt crystal development in the pneumatic
components.
Running additional blank measurements will usually bring the blank measure-
ments down to an acceptable level. Blank measurements will be flagged if they
exceed the following thresholds:
- WBC 0.5 * 103 cells/L

- RBC 0.05 * 106 cells/L
- PLT 15 * 103 cells/L
- HGB 100 g/dL
If the HumaCount 5L was not in use for an extended period of time, the start
up of the pneumatic system components can take significantly longer and re-
quire more blank measurements. To prevent these problems, use the prepare
for shipment process when the HumaCount 5L analyzer will be inactive for an
extended time.
3.1.1.6 Exiting the HumaCount 5L Analyzer

After you have completed lab operations and you are ready to exit the Huma-
Count 5L analyzer, you can:
- Log off
- Shut down the HumaCount 5L
- Power off the HumaCount 5L
- Prepare the HumaCount 5L for shipment
Click or tap the Exit icon on the main menu to access various exit options. Click
or tap the Cancel button to return to normal operation.

3.2 Measurement
3.2.1 USABLE SAMPLES

In this chapter you will find information about the samples usable with the The sample tubes also
HumaCount 5L instrument. called as vial.
3.2.1.1 Sample-tubes
The HumaCount 5L was used, tested with the following K3-EDTA, 13*75mm Please note that in case of the
sample-tubes: Sarstedt Monovette sample
- Sarstedt Monovette tubes the bottom of the blood-
- Becton, Dickinson (BD) Vacutainer storage and the bottom of the
- Terumo Venosafe sample tube is different because
of the syringe. The sampling
Use sample tubes with K3-EDTA anticoagulant! depth on the HumaCount 5L must
You may use sample tubes from other vendors, but consider the following is- be changed if a Sarstedt Mono-
sues: vette sample-tube is in use. The
- In case of manual measurement check if the new tube-type Autosampler can recognize the
- Mechanically fits (13*75 mm family); Sarstedt Monovette tubes. In
- Can be pierced or use it in open-tube mode; case of manual measurements
- Can be handled by the centralizing mechanics; the tube-type should be adjusted
- It is suggested to contact your sales representative before using the new manually. See chapter 3.2.3.7 for
sample-tube. details.
- In case of automated (Autosampler based) measurements contact your sales
representative before using the new sample-tube! It should be tested if the
Autosampler can reliable recognize the tube-type.
Although the mentioned sample-tubes designed for multiple piercing, it is

recommended to remove the cap.
3.2.1.2 Sampling depth

The HumaCount 5L is equipped with a so called piercing needle in order to be
able to aspirate samples from closed sample-tubes. The aspirating hole is on
the side of the needle to prevent crumbles, dried blood particles pass into the
sample-path. It also means that the HumaCount 5L cant aspirate the whole
content of the sample-tube.
62
FIGURE 34
FIGURE 35
The sampling hole is 4,8 mm On the cross-section of the piercing

(~0.19) from needle you can see the 3 grooves de-
the tip of the sampling needle. signed to equalize the pressure in the
closed sample-tubes
The tip of the sampling-needle is positioned 2 mm from the bottom of the

sample-tube. (This clearance prevent the HumaCount 5L accidentally press,
break, pierce into the sample-tube.) The center o aspirating hole is 4.8 mm from
the tip of the needle. It means that the HumaCount 5L cant aspirate the last
8 mm (~0.31) of blood/ control material from the sample-tube.
This is a general phenomenon about the piercing samplers.
3.2.1.3 Open and closed sample tubes

The HumaCount 5L can process both open and closed sample tubes in
manual mode using the sample-rotor. In this case it is the users responsibility to
properly mix the sample.
In automated (Autosampler) mode closed tubes can be processed only since the
Autosampler rotates the sample-tubes. The Autosampler has protection against
using open sample-tubes, the open tube swill be skipped.
3.2.1.4 Sample collection and sample handling

Please consider the following when collecting samples:
Dont forget: all samples - HumaCount 5L needs 100l sample volume for analysis both in closed- and
should be handled as po- open-modes;
tentially infectious material! - The sampler sub-system of the HumaCount 5L is adjusted to take 110 l
sample as gross volume;
- Because of the viscosity of the sample and the occasional vacuum inside
the closed tubes the gross-volume is not aspirated totally all the time;

- By increasing the aspirating time, providing time until a static hydro-pneu-

matic system builds-up the gross sample volume would be reducible. But
this solution would severely decrease the throughput of the HumaCount 5L.
- Use 110l gross-sample volume in your (control) blood consumption
calculations;
- The HumaCount 5L cant aspirate the last 8 mm (~0.31) of blood/ control
material from the sample-tube. (See chapter 3.2.1.2);
- Make sure that the sample tube is filled to the sample level line indicated by
tube manufacturer. The anticoagulant not only prevents the coagulation of
the blood, but also dilutes it. If the volume of the blood is too low, than this
dilution can significantly influence the measurement results;
- Mix properly the blood and the anticoagulant;
- A minimum of 5 minutes should elapse between taking the sample and
running it on an analyzer. Would the sample be run sooner, results may not
be stable due to an improper anti-coagulant interaction. For the exact period
of time check the data-sheet of the used sample-tube;
- Use K3-EDTA anti-coagulated fresh whole blood as sample. Prior to
sampling, mix the sample gently by inverting it 8 times. Do not shake as this
could damage the blood cells;
- Measure the samples within 12 hours;
- It is a good practice to store the blood-samples cooled, but not frozen. The
frozen blood samples hemolyse and not suitable for hematological tests;
- The samples should be processed at room temperature;
- Dont store, deliver the samples in conditions warmer than body-
temperature.
3.2.2 SAMPLE TYPES AND MODES

The HumaCount 5L analyzer is designed to process the following sample
types:
- Whole human blood to determine the hematology parameters of the blood
- Quality control (QC) materials for quality control purposes
- Calibrator materials for calibration of the hematology parameters
QC samples are artificially modified human or human and animal blood samples
with known parameter values. QC samples can be stored for a period of time as
indicated by the manufacturer.
The HumaCount 5L analyzer works in the following modes. The sample mode
must be selected before a measurement starts:
64
- Blank mode: No sample need be presented to run a blank. Blank mode checks
that the measuring system is operating correctly and that blank measure-
ment results are acceptable.
- Human blood mode: Choose one of five human blood modes (Human, Male,
Female, Alternate 1 or Alternate 2). Each mode has a unique set of normal
ranges associated with it.
- Control (QC) mode: The hematological parameters of QC materials are
known prior to analysis. Controls are used to check the long term stability of
the HumaCount 5L analyzer.
Calibration with a calibrator material is not one of the HumaCount 5L sample
modes, but a specific procedure that can be accessed from the Calibration icon
on the main menu.
3.2.3 SAMPLE IDENTIFICATION

The following sample information items are used to uniquely identify samples:
- Sample Mode
- Measurement time: assigned automatically by the HumaCount 5L analyzer
- Result ID: unique database identifier automatically assigned by the Huma-
Count 5L analyzer
- Sample ID: assigned by the operator
o The HumaCount 5L doesnt require the sample ID to be unique
o The sample ID can submitted by:
- Manual typing
- Bar code reading (manual or Autosampler)
- Auto-increment
o The sample ID is not applicable on blank measurements
- Patient:
o A record from the patient database connected to a measurement
o Not applicable for blank and QC measurements
o Can be changed by setting the name or the database identifier of the
patient displayed with the measurement results
o The default patient (ID =1) patient is used if no patient is selected
3.2.3.1 Manual mode

To use Sarstedt Monovette manually presented tubes at the sample rotor,
check the Use only Sarstedt Monovette tube from sample rotor check box in
the Main menu/Settings/System panel.

Always ensure the Use only Sarstedt Monovette tube from sample ro-
tor check box in the Main menu/Settings/System panel is checked if
you are manually presenting Sarstedt Monovette tubes in the sam-
ple rotor. Needle damage, tube damage and spilled blood may result
if Sarstedt Monovette tubes are presented and this option is not che-
cked.
Select the Measure quick link at the top left of the screen to initiate a manual
measurement. The new measurement panel opens, giving you have the follow-
ing options:
- Review the results of the previous measurement by using the Last Measu-
re function. This feature can be useful if you were interrupted during the
measurement batch, and you want to double-check which sample is the last
processed sample.
- Define the sample id of the sample to be processed by clicking or tapping on
the Sample ID field:
o You can type it in the Sample ID using the virtual on-screen keypad or
an external keyboard.
o You can use an external (USB) bar-code reader.
o You can use a auto-generated sample ID.
- Activate or deactivate the automatic generation of sample IDs. If the Auto-
increment mode check box is checked, then the HumaCount 5L will add 1 to
the last sample ID if it was fully numeric or offer 0 if the last sample ID had
any non-numeric characters.
- Connect a patient to the sample by clicking/ tapping on the Patient field:
o The name of this field can be Name or ID depending on the Main
Menu Settings/ Customize/Patients displayed data setting.
o If you dont select a patient then the default patient will be used.
o As you select the patient field, the patient menu is displayed. You can
select an existing patient or define a new one. .
- Select the sample mode:
o Blank: a blank measurement will be processed. This is the only option
available if the pneumatic system is not initialized, or the HumaCount
5L was inactive for an extended period of time. After performing and
accepting a blank measurement the other modes will be available.
o Control: a QC sample is expected. QC measurements initiated from this
menu will not be saved into the QC database, and are not part of the QC
procedure. This mode is intended only as a quick system checks. See
chapter 3.4 for more information about the QC process.
o Human blood modes: Human, Male, Female, Baby and Toddler. Select
the mode which has the appropriate normal ranges.
66
- Start the measurement by clicking or tapping the Start button on the screen
or by pressing the physical Start button located on the front panel of the
HumaCount 5L.
FIGURE 36
Manual Measure Panel
After starting the measurement the sample door rotates and takes the sample
tube inside the HumaCount 5L analyzer. This is a key safety feature of the Hu-
maCount 5L and protects the operator from the sample needle during routine
operation. The Start button changes color to red to indicate that the system is
busy processing the sample. The sample is aspirated inside the analyzer and re-
turned to the operator when the sampling process is complete. As soon as the
measurement results are available the result screen is displayed.
FIGURE 37
Result Screen

- The HumaCount 5L analyzer will be ready to take the next sample after it has
finished cleaning and preparing for the next sample. The Start button will
change to green indicating it is ready to start the next sample measurement.
- On the result screen you have the following options:
- You can print the results by clicking/ tapping on the Print quick link at the
top of the screen. Please note that the printing is a feature that is always
available.
- Return to the measurement panel by clicking or tapping the using the Back
button.
- Run the next sample in routine mode by:
o Editing the Next sample ID just below the actual results
o Accepting the auto-generated sample ID
o Starting the next measurement by clicking/ tapping the Start button
on the screen or by pressing the physical Start button on the front
panel of the HumaCount 5L .
o Please note that in this mode the patient and sample mode will be car
ried over from the previous sample unless they are changed.
3.2.3.2 Automatic Mode

Only human samples in closed sample tubes can be processed in automatic
mode from the Autosampler. QC samples and open tubes must be processed in
manual mode. After starting up the HumaCount 5L , select the Measure quick
link. Process a new blank must be processed if this is the first time a new mea-
surement panel is opened since starting up, or if an earlier blank has expired
due to inactivity. An accepted blank measurement is required before starting
automatic sample processing.
Open the AS panel by using the AS quick link at the top of the screen.
FIGURE 38
Autosampler Info
and AS Panel
68
From the AS panel, you can initiate automated sample measurement in 3 modes:
- Full Scan mode:
o The Autosampler will scan the whole sample tray
o The same sample mode (Human, Male, Female, Baby, Toddler) will be
used for all the samples
o The sample ID is generated from the sample tube barcode (if available)
o It is not possible to assign a patient to automatically processed samples.
The default patient will be used for all samples.
- Free List mode:
o The samples are defined in a list.
o The following parameters can be individually defined per sample:
- Sample ID
- Patient
- Sample mode
o The samples should be placed in the same order in the sample tray as
the samples defined in the list.
o Empty sample positions will be skipped on the sample tray.
- Selected Samples mode:
o A sample can be defined for each position on the sample tray.
o Only defined samples positions on the sample tray will be processed.
Additional samples will be skipped and missing samples will be marked
for later review.
o The following parameters can be defined per sample:
- Sample ID
- Patient
- Sample mode
Samples are automatically scanned and processed in the following order:
- Rack order starting with rack A to rack J
o Rack A is the rack nearest to the front panel of the HumaCount 5L
o Rack J is the rack nearest to the back panel of the HumaCount 5L
- Sample order for each rack starting with sample 1 to sample 10
o Sample 1 is the sample closest to the HumaCount 5L
o Sample 10 is the sample closest to rounded edge of the Autosampler
cover
- Sample A1 is the first sample processed and sample J10 is the last.
3.2.3.3 Full Scan Mode

Full Scan mode is suitable for laboratories where:
- There are batches of samples with the same sample mode,
- Barcode labels are in use, and

- An LIS system rather than the HumaCount 5L is used to associate patients

with sample results.
- Recommended for continuous sample loading
In Full Scan mode it is possible to add more samples to the batch after starting
the automated measurement. As usual, an accepted blank is necessary before
starting automatic sample processing.
FIGURE 39
Full Scan Automatic
Processing Mode
On the Full Scan mode panel you can:

- Return to the AS panel to select a different type of automated measurement
by using the Back function.
- Select a common measure mode for all samples in the tray.
- Swap between the tray and list views by using the View list and View tray
functions.
- Start the automated measurement by clicking or tapping on the Start but-
ton on the GUI.
FIGURE 40
Full Scan Mode Tray
View Progress
70
After starting the automated measurement in Full Scan mode, the Autosampler
will scan all the sample positions on the tray. Any rows with missing racks will
be skipped. The Autosampler can detect the tube type and whether the tube has
a cap. Sample tubes will be skipped if it has no cap or the Autosampler cannot
determine the tube type.
The Autosampler then mixes the sample tube and reads the barcode label if one
is used. The sample tube is then moved to the aspiration position where the
sample is aspirated and measurement is performed. The aspiration and mea-
surement process is the same in automatic mode as in manual mode.
The sample tray progress can be followed in the tray view or the list view. The
results for completed samples can be reviewed by clicking or tapping on a com-
pleted sample.
The patient ID is not editable in the Full Scan mode as it is automatically set to
the default patient. The sample ID is not editable as it is read from the barcode
label. If the barcode label is missing or not readable, the HumaCount 5L analyzer
assigns a default value and allows manual entry of the sample ID.
FIGURE 41
Full Scan Mode Tray
and List Views
The Autosampler allows the addition of sample tubes to a Full Scan process
already in progress. To add more sample tubes, perform the following steps:
- Click or tap the Stop button. The HumaCount 5L will prompt you to wait
until the current sample is completed.
- Acknowledge the message by clicking or tapping the OK button.
- Insert the new samples into a rack.
- Open the cover of the Autosampler.
- Place the new samples behind the last measured sample.
- Close the Autosampler cover.

- Start the automated measurement by clicking or tapping on the Start button on

the GUI or by pressing the physical Start button.
The HumaCount 5L analyzer keeps track of the last analyzed sample on the sample
tray of the Autosampler. After restarting the full scan process the HumaCount 5L
moves the Autosampler to the last processed position and continues scanning from
there.
3.2.3.4 Free list mode

Free List mode is suitable for laboratories where:
- The barcode labels are not used, or the bar codes are not the primary identifiers.
- Samples are arriving from multiple sources in small batches.
- In a given batch there are samples which should be measured using different
modes for different normal ranges.
To start sample measurement in Free List mode, first perform and accept a blank
measurement if one is needed. Click or tap the AS quick link at the top of the screen
and select Free list mode. The Free List mode only requires that samples be placed
in the same sequence as in the free list. It does not require that samples be matched
to exact rack and sample positions. It is not possible to add additional samples to the
batch in free list mode after automated measurement has started..
FIGURE 42
Free List Mode Selection
On the Free List mode panel you can:

- Return to the AS panel to select a different type of automated measurement by
using the Back function
- Add or remove list items
- Define the following parameters for the new list items:
o Measure mode
o Sample ID
o Patient ID
72
functions
ton on the GUI or by pressing the physical Start button
FIGURE 43
Preparing a Free List
As with the Full Scan mode, the Autosampler will scan all the sample positions
on the tray and rows with missing racks will be skipped. The Autosampler will
only process tube types it recognizes with caps attached. The automated mi-
xing, aspiration, and analysis process is the same as the Full Scan Mode, and the
progress can be followed in tray or list view.
The main difference between the Free List mode and the Full Scan mode is that
the Free List mode identifies samples by matching them sequentially to the list,
and comparing their measurement results to the normal range associated with
the sample mode selected for that sample.

FIGURE 44
Free List Mode Progress:
List View
FIGURE 45
List Mode Progress: Tray
View
Sample barcode labels are read and compared with the sample ID that was pre-
viously entered into the free list before starting automatic processing. If the two
do not match, the barcode part of the tray view sample icon changes to red.
If the automated interrupted for any reason, it can be restarted it by clicking
or tapping on the Start button on the screen or by pressing the physical Start
button.
74
3.2.3.5 Selected Samples Mode

Selected Samples mode is suitable for laboratories where:
- Barcode labels are used.
- In a given batch there are samples which should be measured using different
modes for different normal ranges.
- Data security is a concern.
Selected Samples mode can also be used to rerun only certain samples in a
sample tray already processed in one of the other two modes. Samples cannot
be added to the sample tray once automatic processing is started in Selected
Samples mode. An accepted blank measurement is required as with all sample
processing.
In Selected Samples mode, the HumaCount 5L analyzer will only look for samples
in the sample positions selected for analysis. All other samples in sample posi-
tions that are not selected will be ignored. If a sample position is selected for
processing but contains no sample tube, the sample position will be marked for
review.
On the Selected Sample mode panel you can:
- Return to the AS panel to select a different type of automated measurement

by using the Back function.
- Define the samples to be measured:
o Click or tap the sample tray position icon where the selected sample is
located.
o Select the appropriate measure mode.
o Define the sample ID.
o Define the patient ID.
o Save the changes by clicking or tapping the Add button.
- Remove selected samples by clicking or tapping the Remove button.
functions.
ton on the GUI or by pressing the physical Start button

. FIGURE 46
Selected Sample
Mode Panel
3.2.3.6 Interrupting Automatic Processing for Stat Samples

If one or more stat samples need to be processed, you can interrupt automatic pro-
cessing to analyze the stat sample(s) without having to wait until the entire sample
tray has been processed. To interrupt automatic processing for stat specimens, per-
form the following steps:
- Click or tap the Stop button. The HumaCount 5L will prompt you to wait until the
current sample is completed.
- Acknowledge the message by clicking or tapping the OK button.
- Place the stat sample into the sample rotor.
- As soon as the current measurement completes change to the manual measure-
ment panel by clicking or tapping the Measure quick-link at the upper left corner
of the screen.
- Process the stat sample(s) in manual mode.
- Return to the automated measurement panel by clicking or tapping the AS quick
link;
- Restart the measurement by clicking or tapping the Start button or by pressing
the physical Start button.
- The HumaCount 5L will continue automated measurement from where it was
interrupted.
76
3.2.3.7 Controlling The Autosampler

Detailed information about the Autosampler is available from the Autosampler
info panel. You can also reset the Autosampler from this panel. Double click or
tap the Autosampler status in the bottom left corner of the screen to view the
Autosampler info panel. With this panel, you can command the Autosampler to
repeat the last command, or reset the Autosampler. You can also view Autosam-
pler messages with detailed information about the last action or sample tube
processed..
FIGURE 47
Control The Autosampler
with Info Panel
The following is a list of messages from the Autosampler:

- Home message:
o Response after a successful reset
o +HOME_XX.YY (The XX.YY is the software revision number)
- VT zzzzzzz XY:
o Vacutainer style tube detected
o Barcode content: zzzzzzzzzzz
o Tray position XY
- MV zzzzzzz XY:
o Monovette style tube detected
o Barcode content: zzzzzzzzzzz
o Tray position XY
- +F : confirmation that the tube was moved from the mixing to the sampling
position
- The power-on message contains the serial number of the Autosampler unit.

During the reset cycle the Autosampler moves the Autosampler components
to their home position. The mixing stations moves to an upright position, the
active rack moves back on to the sample tray, and the entire tray moves to its
home position.
3.2.4 RESULT DISPLAY

After the analysis is completed, the result screen displays all measured para-
meters, flags, histograms and scatter plots. This information is automatically
stored in the database, and stored result data can be retrieved at any time from
the database.
Histograms and scatter plots can be zoomed for closer inspection. Click or tap
the histogram or scatter plot to magnify it. Click or tap the Close button on the
upper right corner of the image to close it and return to the result display.
FIGURE 48
and Magnified
Scatter Plot
Comparison of parameters to the normal range can be displayed numerically or

graphically. See chapter 4.11 for more information on display of normal range
status. Other kinds of flags are also displayed in the result screen.
78
3.2.4.1 Flagging of the results

The HumaCount 5L can assign so called flags to the measurement reports. The-
se flags can provide:
- Information about the status of the measurement system;
- Information about the correctness of a given measurement;
- Dispersional data alerts. (Mark the out-of-range situations.);
- Interpretive messages.
The out of range situations (dispersional data alerts) are marked on the result
panel (Traditional flag and graphical representation.)
FIGURE 49
The other flags are displayed in the bottom-left screen of the result panel. To get
more information about the flags assigned to the measurement results click/
tap the question mark in the left bottom corner of the result area.
The following flags can be assigned to the measurement results in addition to
the dispersional data alerts.
p - PLT blank high

b - RBC blank high
B - WBC blank high
H - HGB blank high FIGURE 50
C - WBC clogging
c - RBC clogging
X - Differential error
Y - Differential percentage error
F - Differential blank high
x - Baso error
y - Baso percentage error
f - Baso blank high
u - Baso high
D - MON - NEU alert
v - RBC vacuum error
V - WBC vacuum error
s - RBC slice error
S - WBC slice error
l - PLT URI
m - Close to RBC linearity range
M - Out of RBC linearity range

E - EO - NEU alert
Q - MON - LYM alert
A - 4 Diff Alarm
G - Immature Granulocyte?
L - Large Blast?
The G and L flags can be enabled /disabled on service level.
3.2.4.2 Dispersional data alert (out of range situations)

The HumaCount 5L will assign the following out-of-range flags to the affected
parameters (if any):
- + the value of the parameter is higher than the upper limit defined for the
used profile (measurement mode);
- ++ the value of the parameter is higher than the double of upper limit
defined for the used profile (measurement mode);
- - the value of the parameter is lower than the lower limit defined for the
used profile (measurement mode);
- -- the value of the parameter is lower than the half of the lower limit
defined for the used profile (measurement mode);
- * the result for the affected parameter is not interpretable:
- Out of sensor linearity;
- Measurement error;
- No 5 part result if total WBC < 1 * 103 cells/l.
3.2.4.3 Instrument status and fault flags

These flags mark if the operation of the HumaCount 5L is questionable,
maintenance required.
p - PLT blank high

b - RBC blank high
B - WBC blank high
H - HGB blank high
f - Baso blank high
C - WBC clogging
c - RBC clogging
v - RBC vacuum error
V - WBC vacuum error
s - RBC slice error
S - WBC slice error
F - Differential blank high
80
3.2.4.4 Suspect parameter and suspect population flags

These flags mark if the reliability of a given parameter or a set of parameters are
questionable because of the property of the blood-sample or the measurement
process.
X - Differential error
Y - Differential percentage error
x - Baso error
y - Baso percentage error
u - Baso high
D - MON - NEU alert
E - EO - NEU alert
Q - MON - LYM alert
l - PLT URI
m - Close to RBC linearity range
M - Out of RBC linearity range
A - 4 Diff Alarm
3.2.4.5 Interpretive flags
TABLE 9
Morphological flag Morphological flags are raised when the presence of
morphologically abnormal cell types such as immature
Morphological Flags
granulocytes are suspected.
Flag Meaning Cause Action

G Immature The count in the region of Perform a manual count
granulocytes (low - high angle scatter on a stained smear.
of HumaCount 5L) where
the Immature granulocyte
typically located is > 3% of the
total WBC count.
L Atypical The count in the region of Perform a manual count
lymphocytes (low - high angle scatter of on a stained smear
HumaCount 5L) where the
atypical lymphocytes typically
located is > 1% of the total
WBC count.

Interpretive flags infer the presence of distri- TABLE 10

Interpretive flag
butional abnormalities such as leukocytosis. Interpretive Flags
Flag Meaning
Leukopenia WBC --
Leukocytosis WBC + or WBC ++
Neutropenia NEU --
Neutrocytosis NEU ++
Lymphopenia LYM --
Lymphocytosis LYM ++
Monocytosis MON ++
Eosinophilia EOS ++
Basophilia BASO ++
Anemia RBC - or RBC --
Polycythemia RBC + or RBC ++
Microcytic RBC MCV - or MCV --
Macrocytic RBC MCV + or MCV ++
Hypochromic MCHC - or MCHC --
Hyperchromic MCHC + or MCHC ++
Anisocytosis RDW + or RDW ++
Thrombocytopenia PLT --
Thrombocytosis PLT + or PLT ++
Microcytic PLT MPV - or MPV --
Macrocytic PLT MPV + or MPV ++

82
3.2.5 PRINTING REPORTS

Push the Print icon to send the report to the external printer.
3.2.6 THE MEASUREMENT PROCESS

The HumaCount 5L is able to determine 24 para-
WHOLE BLOOD
SAMPLE
WHOLE BLOOD
SAMPLE
meters of whole human blood samples.
Internal dilutions are made to allow measurement
of particles in the sample.
DILUENT MIX DILUTION
Using the manual mode (front panel, individual
sample mode) open, closed, whole blood samples
DILUENT
are supported. Both manual and autosampler
modes take 100L sample.
When you insert the sample and press START
DILUENT button, HumaCount 5L takes the sample
through its sample door and pierces the cap of the
vial (the individual sample door accepts open
LYSE
and closed sample tubes). Approximately 100l of
IMPEDANCE
primary blood sample is taken and is divided into
LYSE
MEASUREMENT
+
IMPEDANCE
MEASUREMENT
TEMPERATURE
CONTROLLED two exact amounts.
LIGHT INCUBATION
ABSORBEANCE
The sample will be distributed into further inter-
nal samples to provide dilutions for RBC, WBC,
TOTAL WBC, HGB RBC, PLT
LYSE2
HGB and 5 population measurements. Lysing
procedures are performed to separate white blood
OPTICAL cells.
MEASUREMENT
RBC and PLT, and total WBC are measured with
4DIFF
impedance technology through 70 and 80m
OPTICAL
MEASUREMENT apertures, respectively. Two portions of the sam-
ple are used for determining five sub-populations
BASO
of WBC in two independent measurements.
Sample results are displayed on the screen as the
process is nearing completion.
.

3.3 Result Interpretation

This chapter provides description about interpreting and understanding reports
provided by the HumaCount 5L analyzer.
3.3.1 THE RESULT SCREEN
FIGURE 51
HumaCount 5L
Result Screen
The HumaCount 5L analyzer result screen is divided into 4 major areas:

1. Sample identification information: contains identifying information used to
uniquely identify this samples information.
2. Parameter information: contains parameter names, values, units, and nor-
mal range. Normal range, linearity, and high blank flags are also displayed
in this area.
3. Histograms and scatter diagrams: Visual elements that provide information
about the measured population dispersion. These are active elements that
can be individually magnified by clicking or tapping.
4. Warning flags area: this area displays warning, interpretive, and morpholo-
gical flags associated with this sample. If flag display overflows its assigned
space, an ellipsis will be displayed and the user can click on the information
icon to see a detailed display of flags.
84
3.3.2 PARAMETER INFORMATION

The parameter information area of the HumaCount 5L analyzer result screen
lists information on 24 parameters.
Par Value Flag Unit/5p Normal Range

FIGURE 52
Parameter
Information Display
Each row shows the parameter name, value, flags (normal range, linearity range,
and high blank), units, and normal range. The units area displays the differential
percentage for the five leukocyte subpopulations (NEU, LYM, MON, EO, BAS).
Parameter names are listed with their standard abbreviation. Parameter va-
lues are always displayed according to their selected unit. In case of error duri-
ng sample evaluation, the software will display E or ---" signs to indicate the
problems. Parameter values falling within the normal range are un-flagged and
displayed with black text. Parameter values falling above the normal range are
marked with a + and displayed with red text, and values falling below the nor-
mal range are marked with a -, and displayed in blue text.
Normal range information can also be conveyed graphically as well as numeri-
cally. This setting can be changed in the Main menu/Settings/Customize panel.
FIGURE 53
Graphical Normal
Range Display
The flags displayed in the parameter information area are as follows:

Normal Normal range flags are raised when a particular parameter is TABLE 11
range flags above or below the normal range, which is defined for the pati-
Normal Range Flags
ent profile currently in effect.
Flag Meaning Hierarchy Color Code
Parameter is under
- Lowest Blue
normal range
Parameter is under the half of
-- Low Blue
the low limit of normal range
+ Parameter is over normal range Lowest Red
Parameter is over the double of

++ Low Red
the high limit of normal range
Linearity Linearity range flags are raised when a particular parameter is TABLE 12
range Flag above or below the linearity range of the device.
Linearity Range Flags
The related parameter is out of
* the linearity range
High N/A
High blank A high blank flag is raised when the blank measurement result FIGURE 54
Flag of the particular parameter was higher than the blank limit.
High Blank Flag
The blank value of the related
! primary parameter is high
Middle N/A
3.3.3 SCATTER DIAGRAMS

The HumaCount 5L analyzer displays the results of the optical measurements
in scatter diagram representation. Scatter diagrams represent two-dimensional
data. There are two scatter diagrams in the patient report: the 4-DIFF and BASO
scatter diagrams.
The 4-DIFF scatter diagram displays cells identified after the first lysing and
optical measurement process. Due to the measurement technology, cells are
classified based on their optically detected properties: low and high angle
scattered light intensity. The optical detector can measure the intensity of the
light scattered or diffracted by each cell. One portion of this scattered light is
proportional to size of the cell, the other is proportional to the complexity of the
internal structures in the cell.
86
Cells in a leukocyte sub-population have similar light scattering properties, al-

lowing them to be grouped together and identified separately from other cell
types. Different colors are used to identify various populations of blood cells.
FIGURE 55
Result Screen Neutrophils
(Magenta)
Scatter Diagrams
Eosinophils
(Orange)
Non-Basophil WBCs
(Blue)
Monocytes
Artifact (Green)
(Black) Basophils
(Magenta)
Lymphocytes (Blue)
RBC and PLT impedance-based measurements are represented by histograms.

These diagrams show the number of cells on the Y axis and the cell size on the
X axis. Smaller cells are displayed on the left side of the histogram, and larger
cells are displayed on the right side. The height of the histogram at a given size
represents the number of cells with that size. Greater histogram height indi-
cates more cells.
FIGURE 56
Result Screen
Histograms
PLT/RBC
Discriminator
PLT RBC
Both the RBC and PLT histograms can be zoomed. Discriminators (thresholds)
are displayed with red color. Platelets are located on the leftmost part of the RBC
histogram to the left of the red discriminator. The PLT histogram is a magnified
version of this region.

3.3.4 WARNINGS
The warnings area of the result screen shows flags and messages related to the
evaluation of the sample. Clicking or tapping the question mark icon on the left
side of the warnings section of the results screen displays a detailed warnings
panel. Click or tap OK to close the detailed warnings panel.
FIGURE 57
Warnings Section of
Results Screen
The HumaCount 5L analyzer provides Warning flags, Morphological flags, and

Interpretive messages in the Warnings panel. The following tables describe
these flags and messages in detail. It also provides guidance on actions the ope- TABLE 13
rator can take to correct the problem described by the flag. Warning Flags
Warning Warning flags are raised when the analyzer detects a problem in the analysis process that may
flags cause incorrect or suspect results or the parameters in the valid blank measurement was too high.
Flag Meaning Cause Action

If other parameters predict a normal sam-
ple then perform a cleaning procedure and
The 4DIFF populations repeat the measurement.
are not clearly distinguish- If 4DIFF results reported then treat them as
A 4 Diff Alarm
able on the scatter reduced reliability. If not all the parameters
diagram. reported or the sample is predicted as patho-
logical then perform a manual count on a
stained smear.
Check cleanliness of the reagents and the Hu-
maCount 5L. Perform cleaning of the Huma-
WBC > WBC blank high
B WBC blank is high Count 5L.
limit
Repeat blank measurement.
Treat WBC result as reduced reliability
Check cleanliness of the reagents and the Hu-
maCount 5L . Perform cleaning of the Huma-
b RBC blank is high RBC > RBC blank high limit
Count 5L. Repeat blank measurement
Treat RBC result as reduced reliability.
88
C WBC clogging Drift in the probe voltage of the Check the reagent connections.
WBC capillary. The two main Perform a cleaning procedure!
reasons for this drift are the See chapter: 5.
misconnected reagent and the Please repeat the measurement.
clogging of the capillary.
c RBC/PLT clogging Drift in the probe voltage of the Check the reagent connections.
RBC capillary. The two main rea- Perform a cleaning procedure!
sons for this drift are the miscon- See chapter: 5.
nected reagent and the clogging Please repeat the measurement.
of the capillary.
D MON - NEU alert The MON and NEU populations If other parameters predict a normal sam-
are not clearly distinguishable ple then perform a cleaning procedure and
on the scatter-gram. repeat the measurement.
If MON, MON%, NEU, NEU% results reported
then treat them as reduced reliability. If not
all the parameters reported or the sample
is predicted as pathological then perform a
manual count on a stained smear.
E EO - NEU alert The EO and NEU populations are If other parameters predict a normal sam-
not clearly distinguishable on the ple then perform a cleaning procedure and
scatter-gram. repeat the measurement.
If EO, EO%, NEU, NEU% results reported then
treat them as reduced reliability. If not all
the parameters reported or the sample is
predicted as pathological then perform a
F Differential blank More than 100 cells detected Check cleanliness of the reagents and the
high during the 4Diff-blank HumaCount 5L. Perform flow cell cleaning of
procedure. the HumaCount 5L.
Repeat blank measurement. Treat 4 Diff
results as reduced reliability.
f Baso blank high More than 100 cells detected Check cleanliness of the reagents and the
during the Baso-blank HumaCount 5L . Perform flow cell cleaning
procedure. of the HumaCount 5L.
Treat BASO result as reduced reliability.
H HGB blank high Last accepted blank result: Check cleanliness of the reagents and the
HGB 10 g/l HumaCount 5L . Perform cleaning of the
HumaCount 5L.
Treat HGB result as reduced reliability.

I PLT URI The PLT-RBC gap is not clearly Check the sample quality. Repeat the sam-
detectable on the PLT-RBC histo- ple. If the problem persists then perform a
gram: small MCV, fractured manual count on a stained smear.
RBC-s, aggregated PLT-s (cold
blood), side-effect of blood-
transfusion.
M Out of RBC linearity The RBC coincidence is over the Check the sample homogeneity. Repeat the
range limit: too high RBC count. sample with manual pre-dilution.
m Close to RBC l The RBC coincidence is close Treat RBC result as reduced reliability.
inearity range to the limit: too high RBC count. Check the sample homogeneity. Repeat the
sample with manual pre-dilution.
O High linearity range If any of RBC,PLT or WBC results Perform manual pre-dilution of sample and
limit exceeded are higher than high linearity re-measure it.
range limits.
o Low linearity range If any of RBC,PLT or WBC results Non
limit exceeded are lower than Low linearity
range limits.
p PLT blank high Last accepted blank result: Check cleanliness of the reagents and the
PLT 15 * 103 cells/l HumaCount 5L . Perform cleaning of the Hu-
maCount 5L. Repeat blank measurement.
Treat PLT result as reduced reliability.
Q MON - LYM alert The MON and LYM populations If other parameters predict a normal sam-
are not clearly distinguishable ple then perform a cleaning procedure and
on the scatter-gram. repeat the measurement.
If MON, MON%, LYM, LYM% results reported
then treat them as reduced reliability. If not
all the parameters reported or the sample
is predicted as pathological then perform a
S WBC measurement The distribution of the RBC Perform cleaning of the HumaCount 5L.
statistics warning detection changes in time. Check the homogeneity, the temperature
It points to clogging, non- and the coagulation of the sample.
homogeneous sample, cold Repeat the sample.
sample, partial coagulation
of the sample.
s RBC measurement The distribution of the RBC Perform cleaning of the HumaCount 5L.
statistics warning detection changes in time. It Check the homogeneity, the temperature
points to clogging, non- and the coagulation of the sample.
homogeneous sample, Repeat the sample.
cold sample, partial coa-
gulation of the sample.
T Blood detector error Blood Detector malfunction Check BD and its connection to the LSDACQ
received signals are all zeros card. Check sampling tube connection to BD.
or not received signals)
90
u Baso high The number of the BASO Repeat the measurement or perform a ma-
population is high or there are nual count on a stained smear.
lyse-resistant cells in the sample.
V WBC vacuum There is a (partial) clogging or Perform cleaning of the HumaCount 5 L.
warning leakage in the RBC part of mea- Perform a self-test.
surement system. A faulty/ If vacuum problems persist then call for
worn-out pump can create service.
vacuum errors as well.
v RBC vacuum There is a (partial) clogging or Check sample volume in sample vial. Check
warning leakage in the RBC part of mea- sampling process. Re-run sample.
surement system. A faulty/
worn-out pump can create
vacuum errors as well.
W Sampling warning Blood Detector detected a sample Check sample volume in sample vial. Check
volume that was too small. sampling process. Re-run sample.
X Differential error Not enough cells detected Perform a flow cell cleaning procedure!
during the 4DIFF WBC Repeat the measurement. If the problem
differentiating. persists then ask for service.
x Baso error Not enough cells detected If the total-WBC count is below
during the Baso WBC 2 * 103 cells/l then perform a manual
differentiating. count on a stained smear.
Perform a flow cell cleaning procedure!
Repeat the measurement. If the problem
persists then ask for service.
Y Differential percen- Algorithm error while distingu- Repeat the measurement. If the problem
tage error ishing the WBC-s in the BASO persists on a given sample then perform a
procedure. manual count on a stained smear.
y Baso percentage Algorithm error while distingu- Repeat the measurement. If the problem
error ishing the WBC-s in the BASO persists on a given sample then perform a
procedure. manual count on a stained smear.
Z WBC noise high During WBC count there is too Perform Clean process. Perform Hard Clean
much (more than 10% of the process.
total) detected pulse on the first
10 channel of the 255 channel
full range. This may be caused by
lyse resistant RBC, electronic
noise, contaminated WBC cham-
ber or contaminated reagents.

3.4 Quality Control Control materials must be

Regular use of quality control (QC) ensures that the HumaCount 5L analyzer is used before their expiration
operating optimally. Stable recovery of standard QC material parameters as- date. Always observe the control
sures the operator that the HumaCount 5L is operating consistently on a day- manufacturers instructions for
to-day basis and is functioning correctly. storage and use. Control materi-
By analyzing control materials on a regular basis, day-to-day reproducibility and als must be well mixed before
general condition of the analyzer can be monitored. Target values and accep- use.
table (tolerance) ranges for each parameter can be specified for an unlimited
number of QC materials. Human recommends the use of CD DIFF controls.
The HumaCount 5L analyzer does not limit the number of QC material lots or
the number of QC measurement runs that are stored in the control database.
Each QC measurement run is saved to the selected QC material lot.
QC lots can be commercial control materials or a whole human blood sample
whose parameter values and ranges are determined by other means. The ad-
vantage of a commercial control material is that is shelf life is much longer than
human blood, allowing control of the analyzer for a longer period of time.
Controls in the HumaCount 5L are processed in manual mode only. To access
the QC panel, select the QC icon on the main menu.
FIGURE 58
QC Panel
92
3.4.1 SET QC REFERENCE

Before taking any QC measurements, target values and acceptable ranges must
be specified for a QC lot of control material. Click or tap the Set QC reference
button to display the Set QC panel.
FIGURE 59
Set QC Reference Panel
The QC name is the name that will be displayed for selecting the control to
associate with a QC measurement. Enter the identifying information, and the
target values and tolerance ranges for any parameters that are to be controlled
with the HumaCount 5L QC system. To exclude a parameter from the QC pro-
cedure, leave its target value and tolerance range field empty. Press the Save
reference button after data entry is completed.
Tapping the Load QC reference button will allow filling QC material data elec-
tronically using a file provided by the manufacturer of the analyzer. A dialog
will open. Browse to the correct folder, and select the file by tapping the check-
box in front of the filename.
The file contains information for all three levels of the control material (Low,
Normal and High). All three levels will be loaded into the system and will be-
come selectable in the QC menu.

FIGURE 60
3.4.2 QC MEASURE
To run a QC measurement , please ensure that a valid blank measurement has
been run and accepted. Associate the QC measurement to the correct control
material lot by select the matching QC name in the selector below the QC mea-
sure button on the QC panel. Place the control material sample tube in the sam-
ple rotor and click or tap QC measure.
The QC measurement results will be added to the QC database and associated
with matching QC material lot.
3.4.3 VIEW QC REFERENCES

Click or tap the View QC References button to see a list of QC lot references sto-
red in the HumaCount 5L analyzer control database. Target values and ranges
can be viewed for any stored QC references.
3.4.4 VIEW QC DATA

Selecting View QC data displays QC runs stored in the QC database in a table
format that operates the same way as the HumaCount 5L analyzer database.
QC measurement results will have sequential ID numbers. Option buttons are
provided to switch back and forth between viewing QC data and viewing QC
diagrams.
3.4.5 VIEW QC DIAGRAMS

Click or tap View QC diagrams to see the Levey-Jennings charts for control mea-
surements.
94
FIGURE 61
View QC Diagrams Panel
Means, standard deviations (StDev) and coefficients of variation (CVar) are cal-
culated based on the QC analyses. The dotted lines delineate acceptable ranges
on Levey-Jennings charts. Use the selector control at the top of the panel to view
graphical control information for other lots of control materials.

3.4.5.1 Log off

If you want to log off from the active user-session on the HumaCount 5L then
use the Main menu/ Exit/ Logoff function!
As the log-off procedure is completed the login panel is displayed.
FIGURE 62
3.4.5.2 Shut down

The regular shutdown procedure must be followed to maintain reliable If the HumaCount 5L is
operation of the instrument. powered off without the
If you want to shut-down the HumaCount 5L then use the Main menu/ Exit/ proper shutdown/ preparing for
Shutdown function! shipment procedure then: The
pneumatics can lock in an
FIGURE 63 undefined state and the next
startup/ pneumatics initializa-
tion can take a longer time with
higher reagent consumption; The
The shutdown procedure has 2 main parts: upper software part of the Huma-
- Shutting down the pneumatics part. It is performed only if the pneumatics Count 5L and / or the Windows
was initialized. (A measurement, QC, calibration cycle etc. was performed); XP operating system can lose
- Shutting down the upper software part and the Windows XP operating data or can damage. It is possible
system. that the HumaCount 5L can be
restarted by service action only
During the shutdown of the pneumatics the analyzer can perform one or more after an improper shut-down/
of the following steps based on the actual status of the pneumatics: power-off action.
- Perform a cleaning cycle. (The HumaCount 5L will ask for the cleaning
reagent.); use household bleach
- Rinse the pneumatics;
- Empty the reagent lines and prime them with the necessary amount of After switching off the Huma-
liquids to allow the next quick startup. Count 5L it can take up to
15 seconds until the control LEDs
Do not turn the analyzer off during the procedure! of the power supply (PSU) go
dark. This phenomenon is
During the shutdown of the upper software part and the Windows XP occurred by the high capacity
operating system the analyzer saves all the settings, closes the file system and buffer/ filter -capacitors of the
the database and shuts down the built-in PC. PSU.
96
At the end of the shutdown procedure the built-in PC is powered off. It is not
necessary to switch-off the analyzer however it is good practice to switch of the
analyzer at the end of the shutdown procedure if the equipment is not used for
a longer period of time (over night - week-end).
If the HumaCount 5L is not used for a significant period of time or the Huma-
Count 5L is transported to a new location then the preparing for shipment
procedure should be performed instead the simple shutdown procedure.
3.4.5.3 Emergency shut-down
Immediate shut-down
The immediate shut-down can be initiated by pressing the stand-by
The procedures mentioned in button. (The same button which is used to start-up the HumaCount 5L. See
this chapter can damage the chapter 2.2.6.2.) After pressing the stand-by button the upper software part of the
HumaCount 5L or loss/ damage of HumaCount 5L and the Windows XP operating system shuts down and the
data/files can occur. Use these built-in PC powered off.
procedures in case of emergency
only! Possible side-effects:
- The pneumatics gets into an undefined state. the next pneumatics
initialization will take longer time and consumes more reagent;
- The last settings, measurement results are not saved.
It should be avoided to use this procedure as an every-day routine. The following

examples describe situations when the usage of the immediate shut-down is
acceptable:
- An approaching thunder-storm predicts disturbance in the electricity supply.

- In case of loss of the electricity supply this method promptly reduces the
load on the UPS (uninterruptable power supply).
Immediate switch-off
In case of direct danger (like there is a fire in the laboratory) you can directly
power-off the HumaCount 5L using the Power switch (See chapter 2.2.6.2) or
any other emergency device installed at your site.
3.4.5.4 Preparing for shipment

The preparing for shipment procedure prepares the HumaCount 5L for a longer
period of time (over 3-6 days) of inactivity or relocation/ delivery.

If you want to perform the preparing for shipment procedure then use the Main
menu/ Exit/ Prepare for shipment function!
FIGURE 64
This procedure should be used because of the following reasons:
FIGURE 65
- The reagents can spill out if the HumaCount 5L is tilted and the spilled rea-
gents can occur corrosion, electric short circuit etc;
- The reagents can flow out from the HumaCount 5L if the reagent intakes are
disconnected;
- The water can evaporate, and the reagents will be more concentrated:
- The high concentration chemicals can damage the pneumatics (tubes,
valves, syringes) of the HumaCount 5L;
- If the concentration is high enough then the crystallization process
starts and solids crystals form inside the pneumatics. These crystals can
occur high blank and can damage the moving parts (syringes, shear -
valve, valves etc);
- Finally the reagents can totally dry into the pneumatics. The solidified
chemicals block the tubes, valves etc. likely a service action is required to
restore the HumaCount 5L into operational status.
- Different kind of micro-organisms can grow in the pneumatics systems. The
presence of these creatures can lead to high blank results.
98
- If the HumaCount 5L is accidentally stored in extremely low temperature

than the reagent can freeze despite the high salt concentration and the ex-
panding ice can damage the pneumatics parts.
Depending on the ambient conditions it is strongly recommended to perform

the preparing for shipment procedure if the analyzer would be out of use for
more than 3-6 days. The higher temperature and/ or lower humidity decreases
the period of time while the HumaCount 5L can be idle without performing the
preparing for shipment procedure.
The instrument will guide you through the preparing for shipment process step
by step. This process takes about 30 minutes.
Required tools:
- Preparing for shipment tube set
- Distilled water.
After selecting Preparing for shipment the system will prepare itself for the drai-
ning process.
The instrument will ask you to disconnect the reagents from the back, except
the waste!
The system will drain all inner reagent buffers through the instrument.
FIGURE 66
This part of the procedure will take approx. 9 minutes.
The instrument will ask you to connect distilled water to the reagent inputs.
FIGURE 67
Use the special reagent tubing with 3 connectors at the end for this process.
The system will perform priming and full rinsing of the tubing system. The
procedure takes approximately 7 minutes. Do not turn the analyzer off during
this process.

The instrument will ask you to disconnect the reagents from the back, except
the waste!
FIGURE 68
Do not power of the Huma-

Count 5L at this stage! The
message is a bit misleading. First
click/ tap on the OK button, then
The system will drain all liquids from the instrument. Due to the complex tubing wait until the Windows XP
system, and delicate parts within the optical unit, this process needs approxi- exits and shuts down the Huma-
mately 10 minutes. Count 5L. Power off (power switch
see chapter 2.2.6.2) the Huma-
Count 5L only after the shut-
down procedure is completed.
When the process is over, the system will notify you, about switching off the
instrument.
FIGURE 69
Tap/ Click the OK button, wait until the Windows XP exits and power off the
instrument.
This is the time to disconnect the waste container.
Small droplets of liquid can remain in the tubing system after the preparing
for shipment process, and these droplets will not cause malfunction during
transportation or the following start up procedure.
100

DATABASE FUNCTIONS 101
4 DATABASE FUNCTIONS
The HumaCount 5L database stores all measured data including sample results,
QC, and patient data. Each sample result stored includes the complete parame-
ter list, histograms, flags, and identifying data. The HumaCount 5L has a data
capacity of up to 100,000 total records.
To activate Database panel, clicking or tapping the Database quick link on the
top of the screen will take you to the database view from any screen.
FIGURE 70
Accessing the Database
The database can be accessed at any time, even when processing samples in the
background. You can return to the measurement panel anytime to view ongoing
sample measurements.
4.1 Database Overview

The HumaCount 5L analyzer database provides a powerful, easy-to-use method
of storing, accessing, and managing patient and sample result information. The
database of the HumaCount 5L analyzer is capable of storing up to 100,000
measurement, control and patient records.
The database presents information in a table view of rows and columns. Each
row in the database panel represents one sample measurement. Rows are also
called records. Each column in the database consists or sample identification
information or measurement parameter results.
The database information can be scrolled using navigation buttons along the
right and the bottom of the database view, or by a moving a vertical scroll bar.
Database records can be selected individually or in groups. Detailed result views
102
are available for selected database records. Selected records can be printed,
sent to an LIS and exported into a tab file. Various sort options are provided for
quickly finding results. Database records can be exported for storage and back-
up. Exported database information can be later imported for review.
Imported records do not become part of your HumaCount 5L analyzers databa-
se. They are only imported for viewing, but can be sorted, selected, and mana-
ged the same way as with regular data the stored inside the HumaCount 5L ana-
lyzer database. The HumaCount 5L database displays two numerical counters
separated by a slash under the left side of the database table. The left number is
the number of selected rows, and the right number is the total number of rows
in the database.
4.1.1 SCROLLING THE DATABASE VIEW

The limited size of the interactive database display acts like a viewport into the
large amount of information inside your database. You can scroll the database
view to bring desired information into view. The HumaCount 5L analyzer provi-
des several powerful and easy-to-use scrolling methods. The numbered items
below match the items in Figure 71 below.
1. The scrollbar: tapping, holding and moving the scrollbar labeled 1 with the
tip of your finger on the touch screen display will quickly scroll informati-
on in the vertical direction. Clicking and dragging with an optional external
mouse will achieve the same effect.
2. Tapping or clicking the buttons labeled 2 will advance the display by one
line or one column.
3. Tapping or clicking the buttons labeled 3 will advance the display by one
page of information at one time.
4. Tapping or clicking the buttons labeled 4 will advance the display to the
first or last item in the list.

FIGURE 71
Scrolling and Selecting
4 3 2 2 3 4
4.1.1.1 Sorting Database Information

IThe database is sorted by Result ID by default. Clicking or tapping the following
database column headings changes the sort order of the database records:
Sample ID Sample ID entered by the operator or read from a sample TABLE 14

tube barcode label
Database Sort Criteria
Patient Identifier that associates a result record with a patient
records
Analysis Time Time and date this sample tube was analyzed
Result ID Unique sequential identifier assigned by the HumaCount
5L to each records
Clicking or tapping the same column heading again changes the ascending or
descending order of values in the column.
4.1.1.2 Manual Selection of Database Records

Clicking or tapping on a row in the database display single-selects a row. Cli-
cking or tapping it again de-selects the row. Selecting another row will de-select
previously selected rows in single selection. Selected rows are highlighted with
white text on a black background.
Checking the Multiselect check box below the left side of the database table
allows the selection of multiple rows. Tapping or clicking once selects a row, but
104
previous selections remain selected unless you click or tap it again to de-select
it. Un-checking the Multiselect check box will de-select all selected records.
FIGURE 72
Multiselect and
Multiple Selection
Multiple selections are useful for viewing, managing and quickly viewing stati-
stics of only a few selected records.
4.1.1.3 Automatic Selection of Database Records

When the total number of records in a database becomes very large, manual
selection of records can become difficult. The Select by function in the Manage
records panel provides the means to select a group of records automatically ac-
cording to their identifying information.
4.1.1.4 Viewing Detailed Results

Multiple selection is also useful for viewing the detailed results of a few records
rather than navigating through the database. After selecting several records,
clicking or tapping the Details button on the database panel will display the
detailed results for the first record in the selection. Clicking or tapping the Up
or Down buttons on the details screen displays the details of the next record
in the selection.
4.1.1.5 Statistics
After selecting a group of records, click or tap the Statistics button on the da-
tabase panel to view the coefficients of variation (CV) associated with each of
the 24 parameters. This function is useful to quickly measure the imprecision of
multiple runs of the same sample.

4.1.1.6 Managing Database Records

HumaCount 5L analyzer database management functions are accessed by cli-
cking or tapping the Manage records button to bring up the Manage records
panel.
FIGURE 73
Manage Records
Panel
All data manipulation actions that change the data stored in the Huma-
Count 5L database are logged in the HumaCount 5L log. If the multi-user mode
is enabled, the name of the operator logged on at the time the data manipulati-
on occurs will also be stored in the log.
4.1.1.7 Select By
Click or tap the Select by button on the Manage Records panel to display the
Select by panel. The Select by panel allows you to select a group of records with
dates and Result IDs that match criteria entered into the panel.
FIGURE 74
Select By Panel
The Select by panel provides various ways to select records. Only one of the four
selection methods can be chosen.
106
Select day Clicking or tapping the Change button displays a virtu-

al on-screen date keyboard. All records analyzed on the
date entered will be selected.
Select interval The two Change buttons allow entry of a start and
end date. All records on the start date, the end date,
and all dates in between will be selected.
Select all All records in the database will be selected.
Select Result ID Entering one Result ID will select a record with the
same Result ID. Entering two Result IDs will select a
range of records including the start and end Result IDs.
Clicking or tapping the Run select will create a multiple selection of all data-
base records that match the criteria (if any). The Cancel button returns to the
database view and the current selection is not changed.
4.1.1.8 Importing
Clicking or tapping the Import button displays a blank, modified version of the
database panel.
FIGURE 75
Database Importing
Panel
The database importing panel provides the following options:

- The Import button brings up a panel to select previously exported database
record files to load and view.
- Select by performs the select by database function to select a group of im-
ported records according to criteria entered by the operator.
- Details views the detailed result information for all or a selection of impor-
ted records.
- Clear removes selected records from the imported records table, but does
not permanently remove the cleared records from the stored database file.
- Back ends viewing of imported database information and returns to the
HumaCount 5L stored database.

4.1.1.9 Export
The database export panel allows you to select a directory location to store re-
cords in a selection for backup or reference purposes. To back up all records in
the database, first use the select by function to select all records in the database
and export them using the export function.
Clicking or tapping the Export button displays the database export panel.
FIGURE 76
Directory Panel for Data
Storage
Introduce a USB storage device (USB hard drive, memory stick, etc.) into an
available USB port on the back panel of the HumaCount 5L analyzer. Select the
directory to store the exported data and press the Ok button to start the export.
The file format of exported data is an internal format, and can only be read and
interpreted by the HumaCount 5L analyzer using the Import function. Each da-
tabase record is stored as an individual file with a .rp extension.
4.1.1.10 Send to LIS

The Send to LIS button immediately transmits selected database records to the
external LIS according to your LIS settings.
4.1.1.11 Save Tab File

The Save tab file function is used to archive database data to a tab separated
text file. The Save tab file button displays a directory panel, except that the file
saved in the selected location is a tab separated text file rather than a database
backup file. Tab separated text files can be loaded and viewed by a text editor or
imported into spreadsheet software.
108
The filename created by the Save tab file function is generated automatically in
the following format: TAB_YYYYMMDDHHMMSS.txt with the year, month, day,
hour, minute, and second of the time when the operation started.
To archive database data using this function, insert a USB data storage device to
one of the USB inputs on the back panel of the HumaCount 5L analyzer. Select
the file location of your USB data storage device and click or tap the OK button
to begin the export.
See chapter 7.5 for detailed information on the format of the tab separated text
file.
4.1.1.12 Save Raw Data

The save raw data function saves the raw data information associated with a
selection of database records. Raw data files are only suitable for internal use by
Human GmbH staff. Your service engineer may ask you to save raw data files to
help diagnose a service issue.
A confirmation password is required to save raw data. The default factory-set
confirmation password is 555. This password can be changed only by a Human
GmbH certified service engineer.
Insert a USB data storage device to one of the USB inputs on the back panel of
the HumaCount 5L analyzer. Click or tap the Save raw data button on the Ma-
nage records panel, then enter the correct confirmation password. Click or tap
the Ok button to display a directory panel like Figure 62. Select the file location
of your USB data storage device and click or tap the OK button to begin saving
raw data.
4.1.1.13 Delete
The Delete function is used to delete records from a selection permanently from
the HumaCount 5L analyzer database. To permanently delete records, select a
group of records and click or tap the Delete button on the Manage records pa-
nel.
To prevent accidental deletion of data, the HumaCount 5L requests the same
confirmation password used in the save raw data function. After entering the
correct password and clicking or tapping the Ok button, the records will be per-
manently deleted.
The password to allow deleting records is: 555.

4.2 Calibration
The HumaCount 5L analyzer must be calibrated in order to provide correct, reli-
able results. Calibration should be done at the following times:
- At initial installation
- After replacing any component critical to the dilution or measurement pro-
cess
- Any time quality control shows a systematic error or is outside predefined
limits
- At periodic time intervals determined by laboratory regulations
The HumaCount 5L analyzer calibration process consists of running a commer-
cial calibrator material or a human whole blood sample with known parameter
values multiple times. The known parameter values and the average values of
multiple runs are used to calculate calibration factors. The new calibration fac-
tors take effect once they are accepted by the operator.
If you are using a human whole blood as a calibrator, the calibration target va-
lues must be measured on a reference analyzer according to applicable regulati-
ons, standards, or laboratory procedures.
An automated calibration procedure is provided that guides the operator
through the calibration process and performs the calibration factor calculation.
Calibration factors can also be modified directly without running a calibration
procedure. Only the primary measured parameters are calibrated: WBC, RBC,
PLT, HGB, MCV, MPV, and RDWcv.
To view the calibration functions of the HumaCount 5L analyzer, select the Cali-
bration icon on the main menu to display the calibration panel. The Calibration
panel displays an option to calibrate the HumaCount 5L analyzer or to view prior
calibrations.
FIGURE 77
Calibrate Options
110
4.3 Calibrating the HumaCount 5L

Selecting the Calibrate option on the calibration options panel displays the ca-
libration panel.
FIGURE 78
Calibration Panel and
Calibration Run
Result Panel
The limits of the calibration target values are linked to the normal range of the
Human sample mode.
Commercial calibrator material and sample tube should be

handled as a potentially biohazardous material. All applicable
laws, regulations, and laboratory practices should be followed
in the handling and disposal of calibrator materials.
To perform the automated calibration procedure, ensure that the HumaCount

5L pneumatic system is started up and that a valid blank measurement has been
accepted. Perform the following steps:
- Prepare a sample tube with commercial calibrator material or human whole
blood. Ensure that there is sufficient sample volume for three or seven con-
secutive runs.
- Place the calibrator sample tube in the sample rotor.
- Select Three measures or Seven measures according to your laboratorys
standard practices.
- Select Calibrator for a commercial calibrator material or Human for whole
human blood calibration.

- Enter the calibration target values provided with your commercial calibrator
material or the previously determined parameter values for human blood
calibration.
- Click or tap the Next button to begin the calibration process.
- The analyzer displays a blank result screen and begins sample measurement
of the calibration material. Wait for the screen to be populated with results
when sample measurement is complete.
- Click or tap the Accept button if the measurement run is acceptable.
- Click or tap the Start next button to begin the next calibration run. Selec-
ting Start next without accepting a calibration run discards the run. Selec-
ting Abort will abort the entire calibration procedure and discards all cali-
bration results.
- The calibration procedure ends when three or seven accepted calibration
runs are completed. The calibration factors are calculated and presented in
the calibrator factor. The previous calibration factors and the coefficient of
variation (CV) of the sample runs for each parameter are also displayed.
- Select Accept to replace the current calibration factors with the accepted
factors. Selecting Discard eliminates the entire calibration process.
FIGURE 79
Calibrate Factor Panel
The automatic calibration process can be skipped by selecting the Manual cali-
bration mode on the calibration panel and clicking or tapping the Next button
proceeds directly to the calibration factor panel for manual entry of calibration
values. Manually entered calibration values can be accepted in the same way as
calculated factors from calibrator sample runs, and are treated by the Huma-
Count 5L in the same way.
112
4.3.1 VIEW CALIBRATIONS

The view calibrations feature is helpful for reviewing the calibration history for
the analyzer. Increasing or decreasing calibration value trends over time may
indicate a problem that requires service intervention.
To view the calibration history click or tap the View calibration function on the
calibration panel. The calibration history is presented in a table view that can be
navigated in the same way as the database panel.
Any calibration can be deleted. Deleting the last calibration causes the Huma-
Count 5L analyzer to revert to the last accepted calibration.
FIGURE 80
View Calibration Panel
To delete a calibration, click or tap the Delete button. The system will ask you
for a confirmation password to avoid accidental deletion of calibration data. The
confirmation password is set at the factory to 555, and can be changed by your
Human GmbH certified service engineer.

4.4 Patients
The HumaCount 5L analyzer allows the operator to define and store patients in
the patient database during manual measurement. Patients can also be prede-
fined while creating a list for one of the automatic processing modes.
Select the Patients icon on the main menu to display the Patients panel.
FIGURE 81
Patients Panel
The Patients panel displays patient information in the familiar table format of
the HumaCount 5L analyzer database, and operates the same way as the data-
base panel. Use the New function to define new patients, and Edit to change
existing patient information. Details displays patient data in a read-only mode.
The Patient panel can also be accessed by clicking or tapping the Name or Pa-
tient ID field in the Measurement panel. Two additional function buttons are
available if the Patient panel is accessed from the Measurement panel.
The Select ID function associates the currently selected patient to the sample
measurement and returns to the Measurement panel. The Cancel function re-
turns to the measurement panel without selecting any patient to associate to
the sample measurement.
You can select either Name or Patient ID to be displayed as the patient identifier
in the Measurement panel by changing the settings in the Patients displayed
data in the Main Menu/Settings/Customize panel.
114
FIGURE 82
Edit Patient Panel
The Save function saves any changes made. To discard any changes made, sim-
ply click or tap the Back button.
4.5 Settings
The HumaCount 5L analyzer can be tailored to your laboratorys needs by chan-
ging the settings. Click or tap the Settings icon on the main menu to access the
Settings panel.
.
FIGURE 83
Settings Panel

The options available on the Settings panel are:

- Customize
- Laboratory
- External Devices
- System
- Units
- Printer
- Profile Limits
- User
Clicking or tapping one of the buttons in the Settings panel displays the selected
panel where settings changes can be made. Each panel has a Back and Save
button. The Save button saves any changes made and returns to the Settings
panel, and the Back button discards any changes and returns to the Settings
panel.
4.6 Customize Settings

The Customize panel allows you to customize the HumaCount 5L analyzer user
interface language and other preferences about the analyzer operation. Click or
tap the Customize button on the Settings panel to access the Customize panel.
FIGURE 84
Customize Settings Panel
On the Customize panel, you can change the following settings:

- Language select the language that the HumaCount 5L analyzer user in-
terface uses to communicate with the operator. Available languages are
English-US, English-UK, Hungarian, Polish, Turkish, and Italian.
116
- Limit style select Number, Graphical1, and Graphical2 display modes to

change the display method for parameters outside the normal ranges on the
result screens and printed reports.
- Sound volume modify the sound volume up or down
- On screen keyboard active Select whether to use the on-screen virtual key-
boards for displaying information, or an external keyboard.
- Patients displayed data choose Name or Patient ID as the patient identifier
displayed in the Measurement panel.
4.7 Laboratory Settings

The Laboratory settings panel allows entry of seven lines of text up to 50 cha-
racters of descriptive information about the laboratory such as laboratory name,
address, etc. All non-empty lines are displayed at the top of every result printout.
4.8 External Devices

The External Devices panel allows entry of external LIS settings. The HumaCount
5L analyzer support external LIS communications over a serial communications
link. It also supports an Ethernet communications link over the HL7 version 2.5
protocol.
The External Devices panel lets you change the following settings:
- Sending port baud rate select 9600 or 115200 baud for serial LIS connec-
tion.
- Automatic LIS The HumaCount 5L will transmit every measurement result
as soon as it is available if this check box is checked.
- LIS the HumaCount 5L analyzer will use an Ethernet connection rather
than a serial connection of this check box is checked.
- IP the IP address of the external LIS computer should be entered here if an
Ethernet LIS connection is used. IP addresses consist of four numbers from
0 to 255 separated by periods. See your IT administrator for more informati-
on about the IP address of your host LIS computer.
- Port the port number of the external LIS computer should be entered with
here with nor commas if an Ethernet LIS connection is used. Ports are a single
number between 0 and 65535. See your IT administrator for more informati-
on about the port number of your host LIS computer.
- Bidirectional LIS check this check box if the LIS computer will download
lists for one of the list modes for automatic sample processing.

FIGURE 85
External Devices
Settings Panel
4.9 System Settings

System settings change various options about the operation and behavior of the
HumaCount 5L analyzer.
The System settings panel lets you change the following settings:
- Waste container volume select 10L, 20L, or None. Selecting 10L or 20L
changes the waste container tracking display behavior in the reagent status
area at the bottom of the screen. Selecting None assumes waste is being
drained directly into the laboratory drain and disables waste container
tracking.
- Database display limit select All or Last month to change the number of
database records displayed in the database panel. Last month only displays
the last 30 days of measurement results, and All displays all measurement
results stored in the HumaCount 5L database.
- Use only Sarstedt Monovette tube from sample rotor Check this check box
to change the sampling depth for manually presented tubes at the sample
rotor to accommodate Sarstedt Monovette tubes. Uncheck this check box
to manually process standard sample tubes. This setting does not affect au-
tomatic sample processing with the optional Autosampler, which is able to
recognize tube types and change sampling depth automatically.
- Standby time This defines the time period of inactivity before the analyzer
automatically leaves the ready state and drains the pneumatic components
118
to prepare for overnight standby. If this time is set to zero, the analyzer will
never enter the standby state automatically.
- Offline rinsing frequency this defines the time period between automatic
fluidic operations to ensure that fresh reagents are available in critical pneu-
matic components so that the analyzer can quickly return to the ready state
from standby. If this time is set to zero, the analyzer will never perform au-
tomatic fluidic operations while in the standby state, but may increase the
amount of time needed to return to the ready state from standby.
- Screen saver this defines the time period of inactivity before the analyzer
automatically starts the screen saver. Entering a time of zero prevents the
analyzer from every starting the screen saver.
- Special flags (G, A) Checking the check box disables the generation, storage,
LIS transmission and display of the G and A flags on the screen, printout.
FIGURE 86
System Settings Panel
4.10 Units
The Units panel allows the user to choose which units are displayed for certain
parameters.
The following options are available on the Units panel:
- HGB unit choose g/dL or g/L to change the displayed units for the HGB and
MCHC parameters.
- Count unit Choose cells/L or cells/L to change the displayed units for the
parameters in the table below.

Parameter Cells/L Cells/L TABLE 15

WBC 103/L 109/L Count Unit Parameters
LYM 103/L 109/L
NEU 103/L 109/L
MON 103/L 109/L
EO 103/L 109/L
BAS 103/L 109/L
PLT 103/L 109/L
RBC 106/L 1012/L
FIGURE 87
Units Settings Panel
4.10.1 PRINTER SETTINGS

The Printer Settings panel lets you choose which installed printer to use, view
the status of the printer, and change the print behavior of the analyzer during
operation.
The following options are available on the Printer Settings panel:
- Printer select an installed printer to use.
- Printer status indicates the status of the currently selected printer.
- Color printing check this check box to print in color, or uncheck to print in
black and white.
- Double sided printing check this check box to print on both sides of the pa-
per, or uncheck to print on one side only. This option is only available if your
installed printer supports double-sided printing.
120
- Items in queue indicates how many printouts are currently waiting in the
printer queue.
- Cancel all jobs Click or tap this button to cancel printing and clear all items
waiting in the printer queue.
- Printout format select Default, Wide names, or User printout formats.
- Automatic print check this check box to print every sample or control as it
is run.
- Abort press this button to abort automatic print.
- Logo visible check this box to print the Human logo on every printed report.
FIGURE 88
Printer Settings Panel
4.11 Profile Limits Settings

The Profile Limits settings are used to view and modify the normal ranges as-
sociated with the HumaCount 5L analyzers five sample modes: Human, Male,
Female, Alternate 1, and Alternate 2.
The control at the top of the panel selects one of the five sample modes. The
panel is then populated with the lower and upper limit values for each of the
24 parameters. Modify the values as needed, then click or tap Save to save
the new values and return to the Settings panel, or select Back to discard any
changes and return to the Settings panel.

FIGURE 89
Profile Limits Settings Panel
4.12 User Settings

The User Settings panel allows administrators to delete users, or assign admi-
nistrator rights.
FIGURE 90
User Settings Panel
122
Users with Administrator privileges can have access all over the system. Only an
administrator user can grant or revoke administrator rights.
Regular users have limited access to the system. A regular user is
- allowed to modify Settings / Customize only (language, skin, sound volume)
- allowed to run and monitor QC measurements, but cannot define QC target
values
- not allowed to perform Calibration
4.13 Date and Time Adjustment

Double-click or tap the time display on the bottom right side of the screen to
display a time/date settings panel. Change the time and date as needed and
select OK to save or Cancel.
FIGURE 91
Time/Date Settings
The HumaCount 5L analyzer does not support automatic time zone or daylight
savings time changes. Please change the time and date manually as needed.
4.14 Reagent Locking

Reagent locking is a commercial feature of the HumaCount 5L ensuring that
only manufacturer recommended and approved reagents are used with the
analyzer. This way analyzer performance cannot be impaired by incompatible
reagents. All necessary hardware and software elements are installed and con-
figured on each HumaCount 5L unit individually.

Each HC5L-LYSE reagent bottle comes with a reagent key. The key is in a pla-
stic bag glued to the tear-open flap of the cardboard box container. Each key
contains license for 800 measurements.
With active reagent lock there is an administrative limit of measurements
run on the HumaCount 5L.
The HumaCount 5L keeps track of the number of measurements performed. FIGURE 92
If the limit is reached, then the HumaCount 5L will first warn the user about Reagent key inside the Lyse
the fact, then it will refuse to perform further measurements. cardboard box
The analyzer decreases the number of available measurements with each
sample run, even Blank, Calibration and QC measurements. When the coun-
ter decreases below 50, and any sample run is started, the user will receive a
warning message about this counter decreasing. When the number availa-
ble reaches zero, the analyzer will not run more samples.
To increase the number of remaining measurements, you have to upload
measurement licenses from the hardware-key to the HumaCount 5L . The
uploading can be initiated during Lyse reagent level reset.
The hardware-key is similar to a USB memory device but it is not a real USB
memory device. Do not insert it into a USB connector. (The hardware key will FIGURE 93
not harm USB ports, however it cant be predicted how the USB drivers react Reagent Lock socket
if a hardware-key is connected as USB device).
To transfer measurement licenses to the HumaCount 5L:

- Remove the hardware key from its protective packaging.
- Insert the hardware-key into the HK-connector close to the stand-by but-
ton on the rear of the analyzer
- Initiate Reset of Lyse reagent and follow instructions on the screen;
- All (800) measurement licenses will be transferred from the key to the
analyzer.
- Remove the hardware-key from the HumaCount 5L .
- An already used (empty) hardware key cannot be used again
- Collect and return them to your dealer/ service personnel/ sales repre-
sentative for re-cycling OR dispose of them as electronic waste adhering
local regulations.
124

MAINTENANCE 125
5 MAINTENANCE HumaCount 5L is a complex

To ensure reliable operation, regular maintenance, or occasional corrective ac- automated hematology
tions are required. This chapter describes necessary procedures and steps re- analyzer. Special HUMAN GmbH
quired to keep your analyzer in a good operating condition. HumaCount 5L Service Training is
required to resolve major
problems occurring during
5.1 Opening the front panel operation. Electrical and moving
To access the pneumatic system, and to be able to perform some maintenance parts should always be serviced
actions, you have to be able to open the front panel of the instrument. by trained person. There are,
Make sure that nothing is placed on the top, or in front of the analyzer. Grab however some maintenance
the lower sides of the front panel, gently pushing the sides. Pull the lower part actions the operator should
towards you, and lift it up. perform to keep the analyzer in a
Upon opening, a lever becomes visible. Make sure to tilt the front panel upwards reliable and clean state.
so that you can push the lever into the secure position.
FIGURE 94
Do not push on the front pa-

nel while the security level is
in the lock position.
5.2 Closing the front panel

Gently lift the front panel so that the security support lever can be moved to the
free position.
Gently lower the front panel. When it reaches its lowest position, gently push on
the front side to click the lock-levers in place.
FIGURE 95
126
5.2.1 REMOVING THE SIDE PANELS

With the front panel open and secured, thumb screws become visible. Both side
panels are fixed to the instrument with these screws: 2 in the front, and 2 in
the back. The screws are designed to stay on the analyzer to avoid losing them.
Left side covers valves and measuring chambers. It needs to be removed if cham-
ber cleaning is requested by the analyzer.
Right side covers sampling unit and wash head and sampling needle. You need
to open the right side if wash head needs to be cleaned or replaced.
After removing the cover, potentially hazardous parts become

accessible, electronic boards, motors, moving parts, sampling
needle, chambers, tubes and valves.
These components may cause injury, or can get damaged if
handled incorrectly. Only certified personnel should open the
covers. Running measurements with opened cover is not recom-
mended due to the risk of possible injury. Always wear safety
gloves while performing maintenance actions.
When reinstalling side panels, always make sure to re-tighten the thumb screws.
5.2.2 USER MAINTAINABLE PARTS OF THE ANALYZER

There are three user maintenance points in HumaCount 5L:
Shear valve: this is a key component and is responsible for correct sampling and
diluting procedures.
Wash head: key component in keeping the sampling needle clean and thus en-
suring reliable piercing and sampling procedures
Measuring chambers: contamination induced problems (noise, high blank va-

lues) can be resolved by cleaning the plastic chambers
General precautions: Always wear protective gloves when working on internal
parts of the analyzer.

MAINTENANCE 127
5.2.3 MAINTENANCE PROGRAMS IN THE ANALYZER

Maintenance functions can be accessed from the menu system.
FIGURE 96
Cleaning
Shear valve cleaning: drains the shear valve to let the user open and clean the
ceramic valve.
Rinse: washes the tubing system
Clean: cleans the system with external cleaning reagent introduced through re-
agent inlets
Hard clean: performs a cleaning of measurement chambers and connected tu-

bing. The software is going to prompt the user to add 0.5ml cleaning solution
to the specified chamber(s). Add the correct amount of liquid. Higher volume of
liquid added can result in overfilling the chamber(s) and thus can cause leakage.
Drain buffers
Internal Diluent reservoir; Flow cell
Can also drain internal chambers individually, or all buffers together.
Empty chamber
Drains chambers individually, or all chambers together.
Prime - Primes reagents individually, or all reagents together.
Fill
Initial filling of the system with liquids. This must be performed PRIOR to first
use of the instrument after installation.
128
Touch-screen
Touch-screen calibration. The software will instruct you to tap specific areas of
the display. This is going to help calibrate the touch sensitive surface.
5.2.4 CLEANING THE SHEAR VALVE

Any salt build-up on the inner surface of the shear-valve may cause malfunction
during operation. To avoid this problem, it is recommended to clean the shear
valve after every 1500 samples.
You need the following materials to complete the shear-valve cleaning:
A piece of soft cloth dampened with water;
A piece of soft, dry cloth;
A piece of lint-free soft, dry-cloth (like a non-woven sheet);
A pair of gloves;
A pair of tweezers;
A few tooth-picks;
Water.
The shear-valve is in contact with the sample blood. Wear gloves
while cleaning the shear-valve. Handle the materials use to clean
the shear-valve as potentially infectious material.
The parts which should be disassembled / re-assembled are fixed with so called
thumb-screws. No screwdriver or other similar tool required to tighten these
screws. Go to the Maintenance menu, and select Shear Valve Clean function to
initiate the procedure.
FIGURE 97

MAINTENANCE 129
The HumaCount 5L asks for confirmation to start the procedure. After clicking/
tapping the OK button the HumaCount 5L empties the shear-valve and the
connecting tubes. Some liquid can remain inside the tubes and inside the shear-
valve.
As the preparations completed the HumaCount 5L displays the following mes-
sage:
FIGURE 98
Procedure for instruments up to serial number 520024

Dont press the OK until the shear valve is assembled again!
Perform the shear-valve cleaning according to the instructions below!
1. Open the front cover, and secure it with the latch; Locate the shear valve
FIGURE 99
2. Unscrew and remove the Axis screw.

Clean the Axis screw by using water and wipe it dry.
FIGURE 100
130
3. Slide down the upper disk of the shear valve. Due to the extremely smooth
surface of the ceramic discs it is not possible to simply lift up the upper part.
If the shear-valve was not in use over a few days, then apply a few drops of
water to the contact of the upper and lower disks.
FIGURE 101
4. Clean the connecting surfaces of the disks of the shear-valve, the housing of
the valve, the tube connections. Remove any salt-built-ups. Use the tweezers
to push-in the dampened and the dry cloths. You may apply a few drops of
water to soften-up the contaminations. You may use a tooth-pick to remove
salt-crystals from narrow places. Do not use any sharp/ metal / hard object
which can scratch the surface of the shear-valve.
Clean the surrounding and the housing/ mounting of the shear-valve as well
if necessary. Pay attention to clean the aligning surface.
Be sure that no lint/ fibers remain on the connection surfaces of the ceramic
disks..
FIGURE 102
5. After cleaning the shear-valve, the housing and surrounding area, put the
disks together.
6. Put the axis screw into the upper disk. Gently press and rotate the axis
screw until it sinks into the upper disk until the shoulder.

MAINTENANCE 131
7. Firmly push down the axis screw against the spring and start to screw it in.
Before fastening tight the axis screw, be sure that the grooves on the disks
positioned similar to the position on the picture.
Fasten the axis screw hand-tight. (You will clearly feel if you reached the
end of the screw.) The spring adjusts the compressing force; you cant block
the movement of the shear-valve by over tightening the axis screw.
8. Clean the surrounding of the shear-valve again. You can let the salt crystals
and other small parts to fall down. Sweep any particles at the bottom of the
HumaCount 5L though the ventilation holes. Remove the gloves. Close the
front door. Click/ tap the OK button: this informs the HumaCount 5L that
you completed the operation.
Procedure for instruments from serial number 520024
1. Open the front cover, and secure it with the latch and locate the shear valve.
2. Unscrew and remove the Axis screw. Clean the Axis screw by using water
and wipe it dry.
FIGURE 103
3. Slide off the upper disk of the shear valve. Due to the ex tremely smooth
surface of the ceramic discs it is not possible to simply lift away the upper
part. If the shear-valve was not in use for a few days, then apply a few drops
of water to the contact of the upper and lower disks. With time the salt will
get dissolved and the upper disk gets released.
FIGURE 104
132
4. Clean the connecting surfaces of the disks of the shear-valve, the housing of
the valve, the tube connections. Remove any salt-built-ups. Use the tweezers
to push-in the dampened and the dry cloths. You may apply a few drops of
water to soften-up the contaminations. You may use a tooth-pick to remove
salt-crystals from narrow places. Do not use any sharp/ metal / hard object
which can scratch the surface of the shear-valve.
Clean the surrounding and the housing/ mounting of the shear-valve as
well if necessary. Pay attention to clean the aligning surface.
Be sure that no lint/ fibers remain on the connection surfaces of the ceramic
disks.
FIGURE 105
5. After cleaning the shear-valve, the housing and surrounding area, put the
disks together.
6. Put the axis screw into the upper disk. There is a spring applied to the axis
screw. This will guarantee the necessary closing force for the two disks.
Gently press and rotate the axis screw clockwise until it clicks into the lo-
wer part. Twist the axis screw until it stops. The mechanical design of the
screw prevents over-tightening.
7. Clean the surrounding of the shear-valve again. You can let the salt crystals
and other small parts fall down. Sweep any particles at the bottom of the
HumaCount 5L though the ventilation holes. Remove the gloves. Close the
front door. Click/ tap the OK button: this informs the HumaCount 5L that
you completed the operation.
FIGURE 106

MAINTENANCE 133
The HumaCount 5L will check the movement and end-positions of the shear-
valve
5.2.4.1 Cleaning the washing head

The washing head cleans the outer surface of the aspirating tip with diluent. Locate the sampling needle.
Any salt build-up on the lower surface may cause malfunction during operation. Be careful! The sampling
The wash head must be removed from the needle assembly for correct cleaning. needle is sharp, and can cause
Open the front panel, and secure it with the support bar. The right side panel of injury!
the analyzer must be removed to access the wash head. Loosen the 2+2 screws
on the front and rear of the side panel. The panel can be pulled off the analyzer.
The wash head should be twisted off from the needle, and pulled off down-
wards. Use a soft cloth dampened with water to clean the bottom of the wash FIGURE 107
head. FIGURE 108
To put the wash head back:
Push the wash head onto the needle. Push it up as much as you can (taking care
of the sharp needle) and lock it back by twisting it on the holding rods.
Replace the side cover and close the front panel.
5.2.4.2 Cleaning the measuring chambers

If the system keeps reporting high blank values, direct cleaning of measuring
chambers must be carried out.
Open the front panel, and secure it with the support bar. Remove the left side
panel. Loosen the 2+2 screws on the front and rear of the side panel. The panel
can be pulled off the analyzer.
Locate the measuring chambers. Using a pipette, inject 1ml of HC5L Cleaner into
each chamber as instructed by the software. Follow instructions on screen.
134
5.2.5 DAILY CLEANING

At the end of the daily routine, run a measurement with a sampling tube filled
with house hold bleach as a sample. This will clean the whole measurement
related tube path.
After this operation, you can leave HumaCount 5L on for the rest of the day. It
will go into a low power state after a specified time.
5.2.6 SPECIAL CLEANING PROCEDURE

Despite regular cleaning, Emergency cleaning procedure is advisable if the
blank measurement result is too high or unacceptable result appear during the
measurement or calibration.
1. Use the built in cleaning process in the maintenance/prime and clean/clean
menu and check the proper result with a blank measure.
2. If the blank WBC, PLT, RBC is too high fill the MIX, RBC ,WBC chamber up with
Hypochlorite 15% and wait for 2 minutes to let the chemical cleaning to take
place and do a blank measure to check the result.
3. If the blank WBC, PLT, RBC is too high after the step 1 and 2, fill up the
HumaCount 5L analyzer with a mixtures of Hypochlorite and Diluent in the
ratio of 1 plus 10 through the diluent connector. Wait for 2 minutes and
drain the HumaCount 5L after it. Prime the diluent again and check the re-
sult by measure a blank.

MAINTENANCE 135
5.2.7 REPLACING REAGENTS

HumaCount 5L is designed to be able to run continuously without the need to
stop if a reagent container needs to be replaced. To support this feature, inter-
nal buffers keep regents sufficient for one measurement cycle. The analyzer will
warn the user when a reagent is about to run out. An exclamation mark within
a yellow triangle will be displayed by the reagent level indicator.
FIGURE 109
To facilitate replacement, double tapping on the exclamation mark takes you

to an explanation screen. Pressing the Go to.. button will take you further to
the reagent status screen.
FIGURE 110
136
When a reagent is replaced, it is not enough to replace the external container

only, the reagent level counter must also be reset.
Push the button below the corresponding reagent bar to reset its level back
to 100%.
FIGURE 111
5.2.7.1 Disposal of reagent containers
Always follow local regulations of hazardous waste disposal

TROUBLESHOOTING 137
6 TROUBLESHOOTING
Your HumaCount 5L software is equipped with all the functions to keep the ana-
lyzer in good working conditions. Despite careful planning and SW features, the
analyzer can still encounter problems where user interaction is required or the
user needs to be informed of situations when further help is required.
These are called error messages. Error messages can be further classified. Your
analyzer will provide all details to identify the error however most of the times
these errors will be composed of numerical codes. These are important for the
service personnel they can interpret the messages and take necessary actions.
Would you receive error messages with codes, please write them down. If pos-
sible, describe with a few words what you were doing before the error came up.
This is important so that your service engineer can help you when necessary.
The software memorizes every error, but it cannot describe the operation you
performed.
When an error comes up, the software will most of the times try to offer solu-
tions, or will try to resolve the problem and retry the current operation. If this
recovery process fails, or the problem keeps coming back, please contact your
service engineer.
6.1 Software error messages

If Windows XP Embedded operation system errors come up, please
accept the error message and repeat the operation. If there are any
other errors please restart the HumaCount 5L. At the next service vi-
sit, please let the service engineer know about the problem.
Low level error messages provide status information about data acquisition sy-
stem and pneumatic system. Each Error message includes the affected part and
the area of the equipment. Check this area and part to find any irregularities like
clogging, mechanical problems, blocked elements. Try to repeat the operation.
The system will try to recover from the failure. Would it not go away, please
contact your service personnel.
6.1.1 PNEUMATIC ERROR MESSAGES

The analyzer software is designed to be error tolerant, and as such it is able to
deal with minor problems. However, if some physical obstructions or extreme
operating conditions cause some mechanical parts to behave unexpectedly, the
system will give you an error message:
138
FIGURE 112
With the OK button, you can return to the current operation and retry the actual
process.
You can also tap on the Details button and there you will be able to get further
informaion abou the error. It will describe additional conditions of the failure.
The numbers in the second row are important for the service personnel.
FIGURE 113
6.1.2 MECHANICAL PROBLEMS

Most mechanical problems arise because of some physical blockage of the mo-
ving parts. Problems caused by severe blocks are most often accompanied by a
grinding noise. The noise is a result of a motor not being able to move however
most of the time this will not cause mechanical damage to moving parts.
Typical situations can be traced back to salt build-ups around the wash head or
the shear valve. Incorrect operation of cleaning of the system especially after
long inactive periods of time can cause valves or tubes to get filled with some-
what dried salt. These problems can be the sources of dilutor motor noise.
In extreme tube or valve clogging situations the pressure built inside the di-
lutors can cause some tubes to be released from their connections. This sym-
ptom is not normal, but will not cause damage to the system. However, it is
recommended to contact Service Personnel to sort out the cause and resolve
these problems.

TROUBLESHOOTING 139
6.1.3 SAMPLE ROTOR (SR) FAILURES
6.1.3.1 SR Gives Grinding Noise And / Or SW Displays SR Error Messages

- the front panel is not closed properly:
o the opening does not match with the sample rotor door
- there is liquid in the SR, if you can see traces of salt around the SR, contact
Service
- check the washing head for contamination (blood and salt) as excessive salt
build up can prevent the wash head to lift up effectively and the sample
rotor door can get stuck
6.1.3.2 SR Error Appears During Initialization Process:

- check the washing head for contamination (blood and salt)
- contact Service
6.1.3.3 The SR Does Not Turn Into The Analyzer Even With Open Front Panel
- check the washing head for contamination (blood and salt)
6.1.4 NEEDLE MECHANICS, VERTICAL MOTOR (MVERT) PROBLEMS
6.1.4.1 The Needle Carriage Keeps Dropping Back (Down) At Initialization

- Is the wash head and its surrounding free of any salt build-ups?
- salt build up, or thick salt layer at the bottom or on the inside can block the
movement of the needle in the wash head (or the movement of the wash
head around the needle if you like)
- The through hole of the needle in the vertical carriage should be free of salt.
- salt around the needle can even damage the needle and can influence the
sampling process, or sampling quality or amount of sample
- The wash head position relative to the needle and to the SR is not correct
- the wash head comes down too much, and even if lifted, leaves no room for
the SR door to turn
- The vertical rod holding the wash head (if removed or modified) is not in-
serted correctly. The rod was not pushed up to the maximum, and the wash
head is sitting in a position too low.
140
6.1.5 SHEAR VALVE (SV) RELATED ERRORS
6.1.5.1 SV Error At The First Startup

- the SV cannot turn
o make sure that the pull tab has been removed
o check free movement by hand (rotate the shear valve)
- The SV is stuck
o try to open the Shear Valve
6.1.5.2 Grinding Noise After SV Cleaning, (After SV Reinstallation)

- the rotating part cannot reach opto position
- the lower disc is not aligned correctly see chapter 5.2.4
o contact service for guidance
6.1.5.3 SV Leakage
- the upper disc is not sitting well on the lower disc
- open, and reseat the upper disc
- there must not be any opening left between the closing screw and the upper
disc
FIGURE 114
6.1.6 DILUTOR ERRORS

- pinched, clogged tube around dilutor or at the rear reagent tubes
- physical obstruction (foreign material)
6.1.7 PRIMING PROBLEMS
6.1.7.1 The Analyzer Would Not Prime Liquids

- The respective reagent is out

TROUBLESHOOTING 141
- aspirating tube (in container)

o has fallen off
o has a leakage
o is broken
- a reagent buffer is leaking look for liquid below the analyzer
- damaged tube in the system look for leakage, or traces of liquid, contact
Service
6.1.8 ELECTRONICS RELATED PROBLEMS
6.1.8.1 No Image On Display, No Backlight

- contact Service
6.1.8.2 Touch Sensitive Surface Not Working

- connect an external USB mouse
o this will allow clicking on the screen elements
o contact service for resolution of the problem
6.1.8.3 Touch (Click) Is Inaccurate

- the touch screen needs calibration
- connect an external USB mouse
o perform the calibration under Main Menu / Maintenance / Touch
screen calibration
6.1.8.4 The Cursor Seems To Be Moving With Good Ratios, But In A Smaller
Area
- try to calibrate the touch screen. (Use a mouse to access the functions)
- If the problem persists, contact service
6.1.8.5 The Analyzer Does Not Power On

- Check proper power connections, and the state of the (small) switch at the
power supply
- If the above fails, contact Service
6.1.8.6 I2c Errors Displayed At Startup

- Contact Service
142
6.2 Measurement results related problems
6.2.1 FLUCTUATING PLT BACKGROUND VALUES

When the HumaCount 5L is used under increased workload, running even
300 samples a day (meaning 5 hours of continuous operation) is possible.
Despite built-in maintenance programs, the system may require intensive clea-
ning from time to time. If you find that Blank PLT values are increasing and de-
creasing unprecedentedly, please run a Hard Cleaning function.
Go to Main Menu, Maintenance. Tap the Hard Cleaning button to initiate
the procedure. You will need a syringe (10ml) to dose cleaning liquid into the
analyzers measuring chambers. The process is described below.
6.2.2 LONG, SMEARED POPULATION

This image shows that neither the TCU, nor the reagents, nor the mixing cannot
do their jobs.
Possible reason:
- the two lyse reagents are interchanged.
- check tube connections, or container connections
FIGURE 115
6.3 Instrument Diagnostics

This section allows performing diagnostic steps and checking operation history,
or so-called log files.
FIGURE 116

TROUBLESHOOTING 143
6.3.1 SELF TEST OF THE ANALYZER

Initiating a self test will test the key functions and components of the analyzer.
The process takes approximately one minute and gives evaluation of each para-
meter. The acceptable ranges of each tested parameter or function can be found
in the following table.
Tapping any tested parameters small box gives detailed information of the pa-
rameter, limits and comments.
FIGURE 117
By using the Load last selftest function you can check the results of the previ-
ous self-test sequence.
Self test checks parameters for the ranges defined below:
Small buffer time TABLE 16

Big buffer time
Generate1 800 - 4000sec
Generate 3000 - 13000sec
Generate2 800 - 4000sec
Release 3000 - 5500sec
Release 500 - 2000se
Big buffer drift Small buffer drift
Maximum 540 - 560mBar Maximum 225 - 235mBar
Minimum 530 - 560mBar Minimum 215 - 235mBar
Drift -5 - 15mBar Drift -5 - 15mBar
Max vacuum P1 Max vacuum P2
Maximum: 550 1000 mBar Maximum: 550 1000 mBar:
Time: 0 6000 ms Time: 0 6000 ms
144
Null pressures
Pump status
Sheath -20 - 20mBar
Pump1 1-1
Capillary -20 - 20mBar
Pump2 11
Chamber -20 - 20mBar
Noise/Pulse
HGB head
pls/5sec 0 - 2000 pulses
HGB Dark 0 - 3000 pulses
20000pls 19990 - 20050
HGB light 3000 - 60000 pulses
pulses
TCU temperature Laser parameters
Actual Reference +- 0.2 C Reference +-10%
Sink 0 - 55C Laser power 32.0 128.0
Laser DC level HGB head
Laser off 0 - 0.05mV HGB Dark 0 - 3000 pulses
Laser on 0.10 - 0.45mV HGB light 3000 - 60000 pulses
Electrode
Reagent lock
Voltage 45 - 55V
Status: UNLOCKED / LOCKED / NA
Current 620 680A
Available measurements: none
Offset -3.0 - 1mV
Battery /Power supply Temperature
Battery voltage 2.7 - 3.3V WBC pre-heater: none (LSDACQ v3.0),
+12V 11.4 - 12.6V 34.0 -38.0 (LSDACQ v3.1)
-12V -12.6 - -11.4V LSDACQ: none
If any of the values falls outside the above limits, the SW is going to list the er-
rors on the self test report screen.
6.3.2 DAILY LOG

The log option is included for service or troubleshooting purposes. It lists events
and possible problems related to operation or measurements.
By using the swap-box on the top of the panel you can change if
All the log entries are displayed;
The error message are displayed only;
Pneumatic errors
Software errors
User actions
System actions

TROUBLESHOOTING 145
FIGURE 118
6.3.3 REAGENT STATUS

Actual level of reagent bottles is accessible from the menu system.
The analyzer has built-in reagent consumption calculators. The calculated level
of each reagent is indicated on the screen. The height of the bar shows the level
in the container. These levels are also indicated on the screen in the status area.
HumaCount 5L send special message if any of the reagents are running low.
Check and change the reagent container and reset the reagent status bar on the
screen. If the reagent-locking feature is activated then the resetting of the Lyse
reagent activates the uploading of the measurement count from the hardware-
key. If the reagent-lock is in use then please connect the hardware key when
resetting the Lyse reagent-level..
FIGURE 119
146
6.3.4 STATISTICS
This menu item will display number of measurements and number of possible
failure events experienced during operation. Statistical data can be reset by a
certified service engineer only.
FIGURE 120
Statistics display
6.3.5 INFORMATION
This menu item displays instrument specific data (serial numbers, SW versions).
These data are important for maintenance purposes. Your service engineer will
ask for these before a service visit.
FIGURE 121
Statistics display

APPENDIX 147
7 APPENDIX
7.1 Reagent consumption
Reagent consumption / function (ml) TABLE 17

Function
HC 5L Lyse HC 5L Diff HC 5L Dil
StartUp 10 2 128
Measure Blank 7 1 52
Measure 5 part 7 1 52
Measure Calibration 7 1 52
Measure QC 7 1 52
Standby 0 0 11
Wakeup 1 0 9
Cleaning 8 1 91
Hard cleaning 8 1 108
Flow cell cleaning 0 0 63
Shear Valve cleaning 10 1.5 100
Offline (overnight) rinsing 8 1 72
**Prime Diluent (full) 0 0 103
**Prime Lyse 7.5 0 2.5
**Prime DIFF5 0 4 0
**Prime all 22 11.5 103
*DrainDilu 0 0 120
*DrainLyse 60 0 0
*DrainDIFF5P 0 60 0
*DrainAll 60 60 180
FillUp 22 11.5 103
Shutdown 9 1 111
* If internal chambers are filled (volume of chambers:

50 ml each, diluent 2x50 + 50 sheath)
** Prime functions fill internal chambers. The following pneumatic function uses
reagents from the inside buffer while the inside buffer is continuously refilled
to a steady level.
148
7.2 Display Range
TABLE 18
Parameter Range Selectable Dimensions
WBC 1.00 99.99 * 103 / l cells/l, cells/l
RBC 0.00 9.99 * 106 / l cells/l, cells/l
HGB 0 300 g/l g/dl, g/l, mmol/l
HCT 0 100% percentage, absolute
PLT 0 9999 * 10 / l cells/l, cells/l
NEU% 0 -100%
LYM% 0 -100%
MON% 0 -100%
EOS% 0 -100%
BAS% 0 -5%
NEU 0.00 99.99*103 / l
LYM 0.00 99.99*103 / l
MON 0.00 99.99*103 / l
EOS 0.00 99.99*103 / l
BAS 0.00 4.99*103 / l

APPENDIX 149
7.2.1 FLUIDIC SYSTEM FIGURE 122

150
7.3 Printed report Formats
FIGURE 123

APPENDIX 151
FIGURE 124
152
FIGURE 125

APPENDIX 153
FIGURE 126
154
7.4 Performance data
7.4.1 PRECISION
TABLE 19
Parameters CV Range
WBC CV 3% 4.7 * 103 / l WBC 38 * 103 / l
All 5 part parameters (NEU, LYM, MON, EOS, BAS
abs and %) at 4.7 * 103 / l WBC 38 * 103 / l
NEU% CV 5% 87.4% NEU% 47%
LYM% CV 8% 35.6 % LYM% 15%
MON% CV 20% 16.3% MON% 5.3%
EOS% CV 25% 11% EOS% 1.5%
BAS% CV 40% 2.4 % BAS% 1%
NEU CV 5% NEU% 30%
LYM CV 8% LYM% 15%
MON CV 20% MON% 5%
EOS CV 25% EOS% 1.5%
BAS CV 40% BAS% 1%
RBC CV 1.5% 2.5 * 106 / l RBC 5.44 * 106 / l
HGB CV 1.5% 78.5 g/l HGB 184 g/l
HCT CV 2% 20-49 HCT%
MCV CV 1% 65 fl MCV 105 fl
PLT CV 5% 100 * 103 / l PLT 492 * 103 / l
MPV CV 5% 5.6 fl MPV 11.3 fl
7.4.1.1 Accuracy values and ranges
TABLE 20
Accuracy Experienced coefficient Range
against Reference
(Cell-Dyn 3700)
Note 1: the 5part
WBC r = 1.00 0.5*103 / l WBC 56.3*103/l
WBC is not reportable
RBC r = 0.99 2.2 *106 / l RBC 6.3 * 106/l
if the total WBC count is
HGB r = 0.99 68.8 g/l HGB 173 g/l
below 1 *103 / l. (the
HCT r = 0.99 19.5% HCT% 52.6%
quantation error grows PLT r = 0.98 12.5 *103 / l PLT 699*103/l
to high.) NEU% r = 0.99 5.8% NEU% 94.6%
LYM% r = 0.99 2.5% LYM% 79.5%
MON% r = 0.90 1.1% MON% 28.1%
EOS% r = 0.95 0.0% EOS% 23.6%
BAS% r = 0.55 0.1% BAS% 4.2%

APPENDIX 155
7.4.1.2 Linearity values and ranges
Linearity Coefficient of determination Range TABLE 21

WBC r^2 0.95 1*103 / l WBC 100*103/l
RBC r^2 0.95 0.4 *106 / l RBC 7.5 * 106/l
HGB r^2 0.95 13 g/l HGB 227 g/l
PLT r^2 0.95 10*103 / l PLT 873*103/l
7.4.1.3 Carryover values and ranges
Carryover High-to-low effect Range

LO 10*103/l TABLE 22
WBC 0.5% or less
HI 75*103/l
LO 2.3* 106/l
RBC 0.5% or less
HI 7.5* 106/l
LO 90 g/l
HGB 0.5% or less
HI 270 g/l
LO 140 *103 / l
PLT 0.5% or less
HI 730*103 /
7.5 TAB file format

This file format is composed of a header line and consecutive lines containing
records selected for saving. Each parameter is selected by the <TAB> (08h) cha-
racter, allowing easy interfacing or importing into most data processing appli-
cations, like Microsoft Excel. Scatter diagrams and historgrams, flags are NOT
saved in this format.
The header line contains the same column names you can see in the analyzer
database.
Data values are saved as they are stored in the analyzer database, alphanumeri-
cal or numerical. Decimal separator is defined by the actual operating language
of the software.
Example tab separated file
ResultID <TAB>Creation time <TAB>Sample Id <TAB>Creation time <TAB>Mode

<TAB>WBC <TAB>LYM <TAB>NEU <TAB>MON <TAB>EO <TAB>BAS <TAB>LYM%
<TAB>NEU% <TAB>MON% <TAB>EO% <TAB>BAS% <TAB>RBC <TAB>HGB
156
<TAB>HCT <TAB>MCV <TAB>MCH <TAB>MCHC <TAB>RDWsd <TAB>RDWcv

<TAB>PLT <TAB>PDWsd <TAB>PDWcv <TAB>MPV <TAB>PCT <TAB>
7538 <TAB>02/04/2009 15:59:05 <TAB>402 <TAB>02/04/2009 15:59:05

<TAB>Human <TAB>70.65 <TAB>56.66 <TAB>2.9 <TAB>11.09 <TAB>0
<TAB>0 <TAB>80.2 <TAB>4.1 <TAB>15.7 <TAB>0 <TAB>0 <TAB>1.83 <TAB>63
<TAB>33.3 <TAB>181.8 <TAB>34.4 <TAB>190 <TAB>75.8 <TAB>16 <TAB>17
<TAB>16.3 <TAB>43 <TAB>8.9 <TAB>0.02 <TAB>
7540 <TAB>02/04/2009 16:11:13 <TAB>402 <TAB>02/04/2009 16:11:13

<TAB>Human <TAB>70.65 <TAB>62.1 <TAB>1.77 <TAB>6.78 <TAB>0 <TAB>0
<TAB>87.9 <TAB>2.5 <TAB>9.6 <TAB>0 <TAB>0 <TAB>1.83 <TAB>63 <TAB>33.3
<TAB>181.8 <TAB>34.4 <TAB>190 <TAB>75.8 <TAB>16 <TAB>17 <TAB>16.3
<TAB>43 <TAB>8.9 <TAB>0.02 <TAB>
7541 <TAB>02/04/2009 16:13:24 <TAB>402 <TAB>02/04/2009 16:13:24

<TAB>43 <TAB>8.9 <TAB>0.02 <TAB>
7542 <TAB>02/04/2009 16:16:53 <TAB>402 <TAB>02/04/2009 16:16:53

<TAB>43 <TAB>8.9 <TAB>0.02 <TAB>
7543 <TAB>02/04/2009 17:31:12 <TAB>402 <TAB>02/04/2009 17:31:12

<TAB>43 <TAB>8.9 <TAB>0.02 <TAB>
7.5.1.1 Reagent system

See chapter 4.3.1.
HC5L-Diluent
Isotonic solution, used to dilute whole blood and quantitative and qualitative
determination of RBC, WBC, PLT and HGB concentration

APPENDIX 157
HC5L-Lyse
Reagent for stromatolysis of RBC and quantitative determination of WBC
5-part differentiation (LYM, MON, NEU, EOS, BAS) and HGB concentration
measurement.
HC5L-Diff
Quantitative determination of WBC, leukocyte five-part differentiation
(LYM, MON, NEU, EOS, BAS) and HGB concentration.
CD-Diff
For Quality Control
158

HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
Max-Planck-Ring 21 65205 Wiesbaden Germany
Tel.: +49 6122/9988 0 Fax: +49 6122/9988 100
eMail: human@human.de www.human.de

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HumaCount 5L

Cat No. 16430/1

Copyright 2011, Human GmbH, Wiesbaden, Germany. All rights reserved.

SERVICE UND SUPPORT

4 DATABASE FUNCTIONS 101

5.2 CLOSING THE FRONT PANEL 125

1.2 User Warranty

1.3 Intended Use of the Instrument [IVD]

1.4 General Safety Warnings

HumaCount 5L | User manual

1.5 Disposal Management Concept

1.6 Instrument Disinfection

1.7 Warning Symbols

The sample and the waste are potentially

Reagents may cause corrosion or skin

This analyzer contains electronic components.

HumaCount 5L | User manual

HumaCount 5L | User manual

2.1 Installation and first time use

2.1.1 PRIOR THE INSTALLATION

- A suitable location is found for the HumaCount 5L instrument;

2.1.1.1 Select a suitable location

HumaCount 5L | User manual

The image below shows a single HumaCount 5L:

2.1.1.3 Electrical requirements

2.1.1.4 Mechanical issues

2.1.1.5 Connection the reagents

2.1.1.6 Power connection

2.1.2 PERFORMING THE INSTALLATION

HumaCount 5L | User manual

2.1.2.1 Content of the package

2.1.2.2 Visual inspection

2.1.2.3 Moving to the selected location

2.1.2.4 Removing the safety card from the shear valve

HumaCount 5L | User manual

2.1.2.5 Connecting the Autosampler

2.1.2.6 Connecting the reagents The analyzer operates with

The Windows XP operating 2.1.2.8 Connecting the peripherals

HumaCount 5L | User manual

2.1.3.1 Waking up the Autosampler

HumaCount 5L | User manual

2.1.4 PRIMARY SETTINGS

- Date and time;

2.1.4.1 Setting Date and Time

HumaCount 5L | User manual

2.1.4.2 Using the Settings Menu

On the Main menu/ Settings/ Customize panel:

On the Main menu/ Settings/Laboratory panel:

On the Main menu/ Settings/External Devices panel:

On the Main menu/ Settings/System panel: you can specify system-

HumaCount 5L | User manual

2.1.4.3 Adjusting the normal Ranges

2.1.5 HOW TO PROCEED

2.2 The HumaCount 5L

2.2.1 GENERAL DESCRIPTION

HumaCount 5L | User manual

2.2.2 TECHNICAL DATA

Sample type Human whole blood (K3-EDTA anticoagulant)

By means of the front panel keyboard (enter ID)

Sampling method Ceramic shear valve with 3 separated primary loops

CBC+5DIFF mode (22 parameters):

2.2.3 MEASURED PARAMETERS

HumaCount 5L | User manual