Human HumaCount 60TS User manual

HumaCount 60TS
|User Manual
16420/601

REVISION LIST OF THE MANUAL
Rev. /DATE REVISION DESCRIPTION
01/2010-03 First edition
02/2010-07 Update for software 1.4
SYSTEM VERSION
HumaCount 60TS with software version 1.4 .
COPYRIGHT
Copyright 2010, 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 BIOHAZARD WARNING 8
2 SYSTEM DESCRIPTION 11
2.1 THE INSTRUMENT 11
2.1.1 Patient Testing 11
2.1.2 Reagents 12
2.1.3 Technical Operation 12
2.1.4 Calibration 13
2.2 UNPACKING AND INSTALLATION 13
2.2.1 Environmental Factors 14
2.2.2 Turning the Instrument ON, MAIN Menu 16
2.2.3 Turning the Instrument OFF 17
2.2.4 Preparing for Shipment 18
2.2.5 Handling in Emergency 19
2.2.6 Replacing Paper into the Printer 20
2.2.7 Accessories 21
2.3 INSTRUMENT FEATURES 22
2.4 PARTS OF THE ANALYZER 23
2.5 CONTROL MATERIAL 24
2.6 MENU SYSTEM 24
2.6.1 Touch Screen Calibration 24
2.6.2 Navigating in the Menu System 25
2.6.3 Menu Structure 26
2.7 METHOD OF OPERATION 27
2.7.1 Impendance method 27
2.7.2 Principle of HGB Measurement 28
2.7.3 Parameters 28
2.7.4 Absolute and Linearity Ranges of Parameters 30
2.7.5 Quality Control 30

3 ROUTINE UTILIZATION AND MEASUREMENT 35
3.1 SAMPLE HANDLING 35
3.2 SAMPLE ANALYSIS 37
3.2.1 Sample Preparation 37
3.2.2 Running a (new) Sample 38
3.2.3 Results 41
3.2.4 Warning flags 41
3.2.5 Paramter Limits (Normal Ranges) 44
3.2.6 Blank Measurement 44
3.2.7 Using Pre-Diluted Mode 45
3.3 THE MEASUREMENT PROCESS 46
3.3.1 Control Panels 46
3.3.2 Display 47
3.3.3 Touch screen 47
3.4 PRINTING 47
3.4.1 Printouts 47
4 ADVANCED OPERATION 51
4.1 DIAGNOSTICS 51
4.1.1 Device Infomation 51
4.1.2 Self Test 52
4.2 DATABASE 53
4.2.1 Database Service 54
4.2.2 The Filter / Select Function 56
4.2.3 Printing Records 57
4.2.4 Manage Records 57
4.3 CALIBRATION 58
4.3.1 Calibration with factors 59
4.3.2 Calibration by measurement 59
4.4 SETTINGS 60
4.4.1 Printer Settings 61
4.4.2 General Settings 63
4.4.3 Measurement 63
4.4.4 Date and Time 66
4.4.5 Multi User Mode 67
5 MAINTENANCE 71
5.1 CLEANING 71
5.2 REAGENT STATUS 73
5.2.1 How to Empty Waste Container 74

CONTENTS
5.2.2 Neutralization of Waste 74
5.3 WEEKLY USER MAINTENANCE 76
5.3.1 Cleaning Needle Washing Head 76
6 TROUBLESHOOTING 77
6.1 REGULAR TROUBLESHOOTING PROCEDURES 77
6.2 SPECIFICATIONS 77
6.3 FLUIDIC SCHEMATICS 79
7 APPENDIX 81
7.1 REAGENT SOLUTIONS AND CONSUMPTION 81

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
operator’s hand as well as at the maintenance operator’s availability. For accu-
rate installation, use and maintenance, please read the following instructions
carefully. In order to avoid instrument damage or personal injury, carefully read
the ”GENERAL SAFETY WARNINGS”, describing the suitable operating proce-
dures. 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
representativesshallbefreeofanydefectinmaterialorworkmanship,provided
that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no
charge, except for transportation expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace
any item considered as expendable in the course of normal usage, e.g.: lamps,
valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty
if the product is not used in accordance with the manufacturer‘s instructions,
alteredinanywaynotspecifiedbyHUMAN,notregularlymaintained,usedwith
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.

HumaCount 60TS | User manual
6
1.3 Intended Use of the Instrument [IVD]
The instrument is intended for in vitro diagnostic application by professio-
nal 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
HUMANand/ormentionedinthismanual.Placetheproductsothatithasproper
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 ha-
zards.
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.

SAFETY INSTRUCTIONS 7
1.5 Disposal Management Concept
Thecurrentlyvalidlocalregulations governing disposalmustbeobserved.Itisin
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.
Theinstrumentsandelectronic accessories (withoutbatteries,powerpacks 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
regulations.
1.6 Instrument Disinfection
Analytical instruments for in vitro diagnostic involve the handling of human
samplesand controlswhich should be considered at least potentiallyinfectious.
Thereforeeverypartandaccessoryoftherespectiveinstrumentwhichmayhave
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 tho-
roughly disinfect all possibly contaminated parts. Before the instrument is
removedfromthelaboratoryfordisposalorservicing,itmustbedecontaminated.
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 returninglaboratory willbe responsiblefor chargesresulting from
non-acceptance of the instrument by the servicing centre, or from authority’s
interventions.

HumaCount 60TS | User manual
8
1.7 Biohazard warning
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
instrumentwhichmayhavecomeintocontactwithsuchsamplesmustequallybe
considered as potentially infectious.
For safety reasons, we have labeled instruments with the „BIOHAZARD“
warning label below.
FIGURE 1
Biological Hazard
Symbol

SAFETY INSTRUCTIONS 9
Notes:

HumaCount 60TS | User manual
10

SYSTEM DESCRIPTION 11
2 SYSTEM DESCRIPTION
The HumaCount 60TS is a fully automated cell counter designed for in vitro
diagnostic use, developed for small clinics and point-of-care lab offices.
2.1 The Instrument
HumaCount 60TS is a fully automated, bench-top hematology cell counter.
It implements the so-called Coulter-method for counting cells passing through
a small aperture, and measures the hemoglobin content of red blood cells.
The analyzer features a color graphical LCD display module with touch screen,
and has a separate START button.
The software allows sending results to an external printer (via USB port), or to
the 58 mm built-in thermal printer module.
Its internal memory is capable of storing 1000 records with full histograms,
and individual patient data. QC measurements are also stored in separate
database.ThesoftwareoperatingtheinstrumentiseasytoupgradeusingaUSB
pen-drive. The instrument allows connecting to a host computer for
uploadingrecordsstoredinthememorythroughaUSBB(slave)port.Archivingand
restoring of records to and from USB pen-drive is also possible.
2.1.1 PATIENT TESTING
The analyzer can process 60 samples per hour in 3-part WBC differential mode.
Samples can have individual sample data, and additional parameters.
You can print results to an external or to the built-in printer. The user can
customize the report format.
The analyzer determines the following 18 hematology parameters, including
3-part WBC differential, from a 25 ðl whole blood sample:
WBC total white blood cell count
LYM lymphocytes count
MON monocytes count
NEU neutrophil count
LYM% lymphocytes percentage
MON% monocyte percentage
NEU% neutrophil percentage
HGB hemoglobin
RBC red blood cell count
HCT hematocrit
MCV mean corpuscular volume
MCH mean corpuscular hemoglobin
If the equipment is used in a
manner different from which
the manufacturer specified, the
protection provided by the equip-
ment may be impaired. Misuse of
equipment or use other than its
intended purpose will invalidate
conditions of warranty. The
accuracy and precision may also
be impaired.

HumaCount 60TS | User manual
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MCHC mean corpuscular hemoglobin concentration
RDWcv red cell distribution width*
PLT platelet count
PCT platelet percentage
MPV mean platelet volume
PDWcv platelet distribution width*
*RDW and PDW parameters have two forms of representation: CV and SD.
Both parameters describe the distribution width, but from different aspects.
User can select the units to use for displaying RDW and PDW parameters.
2.1.2 REAGENTS
Use only reagents supplied by HUMAN with the analyzer, otherwise accuracy
cannot be guaranteed.
HC-DILUENT: Isotonic saline solution, used to dilute whole blood samples
and to rinse the fluidic system between measuring proce
dures.
HC-LYSE: Creates hemolysate for 3-part WBC differential and for total
WBC and HGB.
HC-CLEANER: For cleaning process of the fluidics.
2.1.3 TECHNICAL OPERATION
As the cell counter is a fully automated instrument, operating it requires
minimal training or technical support. Operator interaction is reduced to the
following:
- Perform a Blank Measurement in case the instrument is not used for a
specific time
- Enter sample and/or patient data
- Insert the sample to be analyzed into the sample holder
- Print results either one-by-one, or in groups by selecting records from the
database
- Perform simple weekly maintenance, as described later in this
description (5.3.).

SYSTEM DESCRIPTION 13
2.1.4 CALIBRATION
HumaCount 60TS arrives to your laboratory factory-calibrated and ready to
use. However, calibration needs updating whenever you find that the results
have slightly changed, or a different or new control material is used. With each
control material you receive for the instrument, you will find a control sheet
listingtheparameterstheinstrumentshould match. Perform thesecalibrations
as explained in a later chapter (4.3).
2.2 Unpacking and Installation
This chapter provides instructions for the unpacking and installation of
HumaCount 60TS hematology analyzer. The procedures described below
must be followed correctly to ensure proper operation and service. Please
carefullyreadandfollowallinstructionsinthisUser’sManualbeforeoperatingthe
analyzer.
This hematology analyzer is a precision instrument: handle with care. Dropping
or other improper handling of the instrument will disturb calibrated mechanic
and electronic components and/or cause damage.
Carefully remove the analyzer from the shipping carton. Inspect the instrument
for any visible signs of damage incurred during shipping. Would you find any
damage, file a claim with the carrier or your distributor immediately. Check
the accessories received against the packing list. Contact Service if anything is
missing.
Place the instrument on a firm work surface in the designated work area, near
an appropriate AC electrical outlet. The power outlet connection MUST be
grounded (see also 2.2.1 – Environmental factors)
Keyboard and external printer:
Attach the keyboard cable to one of the USB A ports on the back of the
instrument. Attach both ends of the printer cable to the appropriate ports
on the printer and HumaCount 60TS. Attach the AC adapter to the printer (if
required) and plug it into an AC outlet.
Host Computer:
The instrument has a built-in USB B port that allows connection to a host
computer. You can export results, including histograms. USB B I/O settings are
located in Settings menu.
For installation instructions for communication, please, contact Service.
Before making connections:
Make sure that all power is in
“OFF” state before connections
(printer, external keyboard) are
made. Carefully read all literature
accompanying the instrument
and its accessories. Pay particular
attention to the operating
procedures for the
Prior to initial operation,
allow the instrument to reach
room temperature (approx.
2 hours). Rapid temperature
changes in an operating unit can
lead to water condensation,
which may damage electronic
parts, and cause malfunction.
Always handle the instru-
ment with care.

HumaCount 60TS | User manual
14
Power supply
Connect the power supply to the instrument. Attach power cord outlet to
the external power supply of HumaCount 60TS and plug the other end into a
properly grounded AC outlet.
Reagent Containers:
Place the reagent containers near the instrument, to an accessible location.
Do not place the containers to a higher position than that of HumaCount 60TS,
because would a tube come off its connector, the fluids spill out. Use the
suppliedconnectingtubesandspecialbottlecaps.Besurethatthecoloroneach
tube and cap match. You can, for example, place the reagent containers below
the desk the analyzer is installed on, as the instrument has sufficient power to
draw the liquids from a lower location.b
All containers should be left open (do not block the small air vent hole on the
special container caps) in order to provide free airflow.
2.2.1 ENVIRONMENTAL FACTORS
Operate HumaCount 60TS within the ambient temperature range of 15…30°C
and relative humidity of 45...85%. The optimum operating temperature is 25°C.
Avoid using the instrument in areas of extreme high or low temperatures or
where it is exposed to direct sunlight. If kept at a temperature less than 10°C,
the instrument should be allowed to stand for an hour at the correct room
temperature before use.
Reagents should be stored at a temperature range of 18…30°C.
Place the instrument in a well-ventilated location. Do not place it near
potentially interfering devices capable of emitting radio frequencies (e.g. radio
or television receiver, radars, centrifuge, X-ray devices, fans, etc.).
Do not switch on the analyzer
before connecting external
power supply to it and to the AC
outlet, as well as before
connecting an external printer or
a keyboard to the analyzer.
Reagents may cause corrosi-
onand skin irritation. If any of
liquidsleakedtocoverofanalyzer
or the furniture, wipe it off
immediately. In case of skin
contact, rinse the liquid with
plenty of water.
FIGURE 2

SYSTEM DESCRIPTION 15
Operation at an altitude over 3000 meters (9000 ft) is not recommended,
because the throughput will be degraded.
Instrument is safe for transient voltages to INSTALLATION CATEGORY II and
POLLUTION DEGREE 2.
Environmental and electrical characteristics provide accuracy and precision of
theinstrumentand maintainahighlevelofoperationalsafetyforlabpersonnel.
2.2.1.1 Electrical requirements
HumaCount 60TS comes with an approved power cord, appropriate for your
power system. Proper use of the appropriate power cord assures adequate
grounding of the system.
2.2.1.2 Space requirements
Itisimportanttoinstalltheinstrumentinasuitablelocation.Apoorlocationcan
adversely affect its performance. Consider the following space requirements:
- Select a location near a power source and close to a suitable drain.
- Place the unit on a clean and level surface.
- Leave at least 0.5m (20in) space on both sides and above the instrument
to access pneumatics and (optional) built in printer. Provide a minimum of
0.2m (8in) between the rear panel and the wall to allow for heat dissipation
and tube clearance.
- Install the reagents in a suitable place that will make your work easy. The
best place is on the ground, below the supporting desk of the instrument.
The pneumatic system is capable of aspirating reagents from containers
being 1m (3ft) below the reagent inputs. Make sure the reagent tubes are
not bent, broken, twisted or blocked in between the desk the instrument
is on and the wall behind. Such circumstances can result in instrument
operation failure.
- DO NOT PLACE the reagents above the instrument, as there can be a risk of
falling and spilling.
2.2.1.3 Peripherals
Connectexternalperipheralsonlywhenboththeinstrumentandtheperipheral
device are off. Possible peripherals are:
external printer
- the printer must be recommended by authorized technician
- the printer must be approved and listed
- the printer must have a CE mark
Improper grounding of the
analyzer bypasses important
safety features and may result in
electrical hazard.
Install the unit on a table or
workbench. If the unit was in-
stalled without a supporting
desktop under the unit, there is a
possibilitythattheanalyzer could
accidentally fall.

HumaCount 60TS | User manual
16
external keyboard
- the external keyboard must be approved
- the external keyboard must have a USB port or suitable adapter
link to host computer via USB port
- serial link cable must be approved by technician
- USB B port (linking to host computer) requires a USB A-B cable and USB
driver software (contact service for availability)
2.2.1.4 Reagents and waste handling
Handle reagents according to national or international regulations.
Waste generated by the unit is biohazard material. Handling and disposal must
happen according to regulations regarding reagent systems. See Section 5.2.2.
2.2.1.5 General points
Themanufacturer guarantees work safety reliabilityand general characteristics
under the following conditions only:
- services and repairs are performed by an authorized technician
- the electrical system of the laboratory follows national and/or international
regulations
- the system is operated according to instructions contained herein
2.2.2 TURNING THE INSTRUMENT ON, MAIN MENU
- In case you use an external printer (for information, read manual shipped
with the printer) connect it and turn it on.
- Turn the analyzer on using the power switch on the rear panel. The ‘ON’
position is marked by the ‘I’ symbol.
After turning on power, there
will not be LCD activity for a few
seconds, but the status LED goes
on.
During start-up, the following
screen is displayed:
The software version number
appears few seconds later, when
the software starts. When SW is
loaded, Main menu is displayed.
Waste contains poisonous
substances (because of
chemical content) and human
origin substances meaning
biohazard. These substances are
representing potential danger to
environment. For this reason, safe
handling of the waste liquid is
very important.
Reagents may cause corrosion
and skin irritation. If any of
the liquids leaked onto the cover
of analyzer or the furniture, wipe
it off immediately. In case of skin
contact, rinse the liquid off with
plenty of water.