User´s Manual

Medonic CA620 + MPA + AD

Medonic CA620 + MPA
Medonic CA620
Medonic CA530 + MPA + AD
Medonic CA530 + MPA
Medonic CA530
Medonic CA620-CellGuard + MPA + AD
Medonic CA620-CellGuard + MPA

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 Contents
Preface ............................................................ 7
1 Safety Instruction ........................................9
1.1 Intended Use .......................................................................... 9
1.2 Counter Indications ............................................................... 9
1.3 Warranty Limitations.............................................................. 9
1.4 General Warnings .................................................................10
1.5 Emergency Procedure .........................................................11
1.6 Warning Signs in Manual.......................................................11
1.7 Signs on Equipment .............................................................12
2 Specifications............................................ 13
2.1 General ...................................................................................13
2.2 Description of Available Parameters..................................13
2.3 Short-List of Specifications..................................................14
2.4 Parameter Ranges ...............................................................16
2.5 Reagents and Reagent Consumption .............................. 17
2.6 Limitations ..............................................................................18
2.7 Differences between CA620 and CA530
(9,16,20 parameters)........................................................... 22
3 Measuring Principles ............................... 25
3.1 RBC,WBC and PLT Concentration Detection ................ 25
3.2 Sizing RBC, WBC and PLT ................................................. 27
3.3 Counting Time RBC & WBC .............................................. 28
3.4 WBC Differentials ................................................................. 28
3.5 MCV (Mean Cell Volume RBCs) ........................................ 30
3.6 RDW% (Red Cell Distribution Width)................................. 30
3.7 RDWa (Red Cell Distribution Width Absolute) ................. 30
3.8 HCT (Hematocrit)................................................................. 30
3.9 PLT (Platelets)....................................................................... 30
3.10 MPV (Mean Platelet Volume) ..............................................31
3.11 PDW (Platelet distribution width) ........................................31
3.12 LPCR (Large Platelets)........................................................ 32
3.13 PCT (Packed Platelet Volume) .......................................... 32
3.14 HGB (Hemoglobin Concentration) ................................... 32
3.15 MCH (Mean Cell Hemoglobin) .......................................... 32
3.16 MCHC (Mean Cell Hemoglobin Concentration)............. 32
4 Parameter Flags....................................... 33
4.1 TU (Time-out Upper Detector) .......................................... 34
4.2 TL (Time-out Lower Detector)........................................... 34
4.3 SE (Statistical Error) ............................................................. 34
4.4 DE (Distribution Error).......................................................... 34
4.5 FD (Floating Discriminator) ................................................. 35
4.6 OF (Offset error HGB) ......................................................... 35
4.7 LO (Low blank level HGB)................................................... 35
4.8 HI (High blank level HGB).................................................... 35
4.9 NG (Negative HGB) ............................................................. 35
4.10 SE (Statistical error HGB).................................................... 36
4.11 TB (Air bubbles).................................................................... 36

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 4.12 NM, OM, TM, BD (WBC Differential Flags) .......................36
4.13 RP (Red Cells Present) ........................................................36
4.14 EC (Expired control)............................................................. 37
4.15 Comments on Flagging Capabilities ................................. 37
5 Installation .................................................39
5.1 Unpacking the Instrument ..................................................39
5.2 Working Conditions .............................................................39
5.3 Mechanical Check and Set-Up.......................................... 41
5.4 Front Panel and Command Keys ......................................44
5.5 Filling the system with reagents.........................................46
6 Initial System Configuration ......................47
6.1 CA620-CellGuard ................................................................ 47
6.2 Setting up the CA620-CellGuard
for Pre-Donor Screening..................................................... 47
6.3 Setting up the CA620-CellGuard
for PLT Concentrate ............................................................48
6.4 CA620/530 ...........................................................................48
6.5 Setting Date and Time.........................................................49
6.6 Printer Configuration............................................................49
6.7 Select Language .................................................................. 51
6.8 Select Units ........................................................................... 51
7 Routine Operation .....................................53
7.1 Background Check..............................................................53
7.2 Analysing the Sample (Open Tube) ..................................54
7.3 Analyzing the Sample (Pre-Dilute).....................................56
7.4 Analysing the Sample (Micro Pipette Adapter, MPA)..... 57
7.5 Analysing the Sample (Cap Piercing Device) ..................58
7.6 Advanced User Options (CA620-CellGuard) ..................60
8 User Interface ........................................... 61
8.1 Sample Memory ................................................................... 61
8.2 Setup Menu...........................................................................64
8.3 Setup Menu 2 .......................................................................68
9 Warning Displays ......................................75
9.1 Warnings Related to the MPA and Pre-Dilute Inlet......... 75
9.2 Stand-By Mode .................................................................... 76
9.3 Reagent Empty .................................................................... 77
9.4 Printer and Serial Output ..................................................... 78
9.5 Auxiliary Warnings/Messages ............................................ 79
10 Calibration and controls ........................... 81
10.1 Introduction ........................................................................... 81
10.2 Use of Calibrators and Controls ........................................ 81
10.3 Calibration on a Known Sample ........................................82
10.4 Calibration Through a Certified Calibrator........................83
10.5 Calibration on Pre-Diluted Capillary Blood .......................85
10.6 Calibration of the MPA.........................................................85
10.7 Calibration of RDW, LYMF and GRAN ..............................86

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 11 QC and Blood Controls .............................87
11.1 Introduction........................................................................... 87
11.2 Initializing the Levey-Jennings Plots and Functions ....... 87
11.3 Use of Blood Controls and Levey-Jennings Plots ......... 88
11.4 Initialization and Use of X-B Function................................ 89
11.5 Display of Blood Control Data.............................................91
12 Printer and Serial Output ......................... 93
12.1 Selecting the Correct Printer Type ................................... 93
12.2 The Serial Output/Hardware Connections ...................... 93
12.3 The Serial Output Format ................................................... 94
13 Maintenance, Shut-Down & Transport .... 95
13.1 Daily Maintenance ............................................................... 95
13.2 Monthly Maintenance ......................................................... 95
13.3 Three (3) Month Maintenance........................................... 95
13.4 Short Term Transport.......................................................... 96
13.5 Re-packaging and Long Term Transport........................ 96
13.6 Permanent Shut-Down and Storing the Instrument...... 97
13.7 Disposal information ............................................................ 97
14 Trouble Shooting...................................... 99
14.1 Counting Time HI (TU & TL) ............................................... 99
14.2 Counting Time LO................................................................ 99
14.3 HGB Value Flagged with LO............................................... 99
14.4 HGB Value Flagged with HI .............................................. 100
14.5 HGB Value Flagged with OF ............................................ 100
14.6 High Background PLT ....................................................... 100
14.7 Indication Number XXX Displayed.................................... 101
14.8 Cell Diff. Only on a Few Samples..................................... 102
14.9 Cap Piercing Device .......................................................... 102
14.10Clogging in Aspiration Tube ............................................. 104
Index ............................................................ 105

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 Preface
Name of product, serial number and software
version
This manual describes:
CA620, CA530 and CA620-CellGuard as well as the optional devices “Closed
Tube Adapter” (Cap Percing Device) and MPA (Micro Pipette Adapter)
Serial number of the instrument is found on the serial plate on the rear of the in-
strument. Software version is displayed on the main menu in the upper right cor-
ner of the display, see picture below marked “A”

1177en.gif

Other documentation related to this manual:

Additional applications and notes, as well as service manual, product data sheets
on reagents and calibrators are available from your local distributor and listed on
the Boule support server, which is exclusively available to your authorized distrib-
utor.

Specimen, special conditions of collection and

storage conditions
General instructions for (human) blood collection, handling, storage of samples
etc. are described in the booklet “Hematology for sales and service engineers”
which is available from your authorized distributor.

Operator training
Additonal operator training is not required under the following conditions:
1. The operator must have basic scills in working under laboratory conditions.
2. The operator must have basic scills in hematology.
3. The operator must be aware of IVD(EU) and FDA(USA) requirements re-
garding laboratory equipment for In Vitro Diagnostic purposes.
4. The operator must read and understand this manual.

Component lists, tools and other consumables

These are listed, including their special functions, in the Service Manual distrib-
uted on CD-ROM and available via the Interrnet ‘on-line’ to your authorized dis-
tributor.

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 Name and address of manufacturer:
Boule Medical AB
P.O. Box 42056
SE-126 13 Stockholm
Sweden
Telephone: +46 8 744 77 00
Fax: +46 8 744 77 20
e-mail: [email protected]

Name and address of distributor

Distributors are listed on:
http.//www.boule.se

Standards
EN591:2001
IVD 98/79/EG
SSEN 61010-2-101 (Low Voltage 73/23/EEC)
EN 61326 (1997) with amendment EN 61326/A1 (1998) (EMC 89/336/EEC)
Standards harmonized with FDA/UL

Manual number
1504062en
Date of issue
August 2003

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 1 Safety Instruction
1.1 Intended Use
CA620/530 and CA620-CellGuard
The CA620/530 is a fully automated hematology analyser used for in vitro diag-
nostic testing of whole blood specimens under laboratory conditions. The user
must have basic skills in laboratory practice and must be aware of the guidelines
in “Good Laboratory Practice”.
The CA620-CellGuard is intended to be used especially in blood banks as pre do-
nor screening as well as a quality control tool for PLT concentrates in a blood
bank production facility.
During the installation and set-up, the CA620-CellGuard can be configured either
for pre-donor screening, in which the instrument is fully identical to the CA620,
or for quality control to measure PLT concentrates.

1.2 Counter Indications

• Do not use the instrument outdoors.
Usage outside the specified temperature and humidity range might result in
instrument malfunction or short circuit.
- Turn off the power immediately and contact your service department.
• Do not modify the instrument.
Modification without written instructions from the manufacturer might
cause erroneous results or risk for electrical shock.
• Do not remove the cover. Only authorized service personnel is allowed to
open the instrument.
• Do not use the instrument for other purposes then as indicated in this man-
ual.

1.3 Warranty Limitations

• Service and instrument maintenance must be performed by Boule Medical
AB or authorized service personnel. (Referred to hereafter in this manual as
Boule).
• Use only original spare parts and by Boule authorized reagents, blood, cali-
brators and cleaners.
Boule has designed the Medonic instruments as systems for optimal per-
formance. Substituting reagents, calibrators, controls, and components not
recommended by Boule may adversely affect the performance of the instru-
ment. If the substituted products are defective or adversely affect the per-
formance of the instrument it may void your warranty. Each Boule system
is tested at the factory using our recommended reagents, calibrators and
controls, all performance claims are generated as part of this complete sys-
tem.
• System operators and laboratory supervisors are responsible that Boule
products are operated and maintained in accordance to the procedures de-
scribed in the Product Labelling (manuals, package inserts and bulletins of
any kind). They are also responsible for determining that product perform-
ance conforms to the applicable claims.

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 Safety Instruction

If, under these prescribed conditions of operation and maintenance, an aberrant

or abnormal result occurs, as defined by the laboratory protocol, laboratory per-
sonnel should first make certain that the system is performing and is being oper-
ated in accordance with the Product Labelling. The laboratory protocol should
than be followed to advise the clinician in case a result appears to have deviated
from the norms established by the laboratory.
Boule products do not make diagnosis on patients. Boule intends its diagnostic
products (systems, software and hardware) to be used to collect data reflecting
the patient's hematological status at a certain point of time. Such data may be used
in conjunction with other diagnostic information and with the attending physi-
cians evaluation of the patients condition to arrive at a diagnosis and a clinical
course of treatment.

1.4 General Warnings

Boule incorporates safety features within the instrument in order to protect the
operator from injury, the instrument from damage and the test results from inac-
curacies.

Electrical hazard
• Do not spill blood, reagent, drop metal objects such as wire staples or paper
clips into the instrument. This might cause a short circuit.
If this should occur, turn off the power immediately and contact your serv-
ice department.
Note: The cover should only be opened/removed by authorised service
personnel.
• Do not touch the electrical circuits inside the cover.
There is a hazard of electrical shock.
Note: The cover should only be opened/removed by authorised service
personnel.

Potentially biohazardous material

Because no test method can offer complete assurance that HIV, Hepatitis B or C
viruses, or other infectious agents are absent, these products should be handled
at the Biosafety Level 2 as recommended for any infectious human blood speci-
mens in Protection of Laboratory Workers From Infectious Disease Transmitted
by Blood, Body Fluids and Tissues- 2nd Edition, Tentative Guidelines(1991)
Document M29-T2 promulgated by the National Committee for Clinical Lab.
Standards in the U.S.A. (NCCLS)

Contamination hazard
• Always wear protective gloves and/or goggles when handling infectious or
potentially infectious materials.
• Handle samples with great care.
There is a risk of infection if contaminated blood splashes.
- If blood splashes, enter your eye or a cut, wash it off with plenty of water.
• Do not touch the waste liquid when discarding waste or disassembling/as-
sembling the related parts outside the instrument.
Risk of infection from contaminated blood.
-If you should touch the waste liquid inadvertently, wash off with disinfect-
ant first, then wash it off with soap.

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 Safety Instruction

• When handling reagents.

- If a reagent happens to enter your eye, wash it off immediately using plenty
of water and take action to seek medical treatment at once.
- If it happens to adhere to the hand or skin of other body parts, wash it off
using plenty of water.
- If you should swallow it inadvertently, take action to seek medical treat-
ment at once.

Crush hazard
• Always switch off the instrument when opening the front “door”. crush
hazard can occur if the option “Cap Piercing Device” is installed in the
equipment. See Signs on Equipment on page 12.
Note: The cover should only be opened/removed by authorised personnel
during operation.

1.5 Emergency Procedure

• In case of emergency due to an obvious malfunction of the instrument e.g.
smoke or liquid coming out from the inside, proceed as follows:
1. Switch off the instrument immediately by:
Pulling out the mains cord from the mains supply.
2. Contact your authorized distributor’s service department immediately.

1.6 Warning Signs in Manual

These warning signs in the manual are used to identify possible hazards and to
call the operators attention to the existence of this condition.
Indicates operating procedures, practices and so
on, that could result in personal injury or loss of
life if not correctly followed.

Warning

Indicates operating procedures, practices and so

on that could result in damage or destruction of
equipment if not strictly observed.

Caution

Emphasizes operating procedures, practices and

so on that must be followed to avoid erroneous
results.

Important

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 Safety Instruction

1.7 Signs on Equipment

Front/side view of the Instrument
1

1013.jpg

Open door view of the Instrument

1022.jpg

Back view of the Instrument

1040.jpg

1. This label indicates that the safety instructions in the manual must be read
before opening the front door of the instrument.
2. This label indicates a potential bio hazard due to blood exposure or possible
contaminated waste.
3. This label indicates a potential crush hazard. Disconnect the instrument
from the mains outlet before opening the front door. Only authorized per-
sonell are allowed to open front door.
4. Serial Number, Voltage/Fuse specifications and CE / UL markings.

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 2 Specifications
2.1 General
The operator works with a menu from which the desired program is chosen, e.g.
discriminator settings, calibration, cleaning etc.
Two external reagent reservoirs are used:
• Isotonic diluent.
• Hemolyzing reagent.
Whenever one of these external reservoirs is empty, this is indicated on the dis-
play.
The instrument also performs a 3-part WBC differential by means of a cyanide-
free hemolyzing reagent.
A sample memory is available, protected against mains power failures.
Sample search, selective printing and QC options are available.
The instrument is a fully automated hematology analyser designed to measure up
to 20 parameters using whole blood from an open inlet, closed tubes, micro pi-
pettes 20µl or pre-diluted blood.

2.2 Description of Available Parameters

• The number of Red Blood Cells (RBC)
• The number of White Blood Cells (WBC)
• The number of Platelets (PLT)
• The Mean Cell Volume of Red Cells (MCV)
• The Mean Platelet Volume (MPV)
• The Hemoglobin Concentration (HGB)
The size distributions of PLT, RBC and WBC are measured at the same time as
the above-mentioned parameters.
• Hematocrit (HCT)
• The Mean Cell Hemoglobin (MCH)
• The Mean Cell Hemoglobin Concentration (MCHC)
• The Red Cell Distribution Width (RDW%)
• The Lymphocyte concentration in absolute number and per- (LYMF)
centage
• The MID-sized Cells (e.g.Monocytes) in absolute number and (MID)
percentage
• The Granulocytes concentration in absolute number and per- (GRAN)
centage
• The Red Cell Distribution Width (Absolute) (RDWa)

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 Specifications

• The Platelet Distribution Width (Absolute) (PDW)

• The Platelet Macro Range > 12 fl in% (LPCR)
• The Platelet Packed Volume (PCT)

The instrument employs the electronic impedance principle for cell counting and
sizing, and a colorimetric method for measuring hemoglobin. A microprocessor
is used to measure the parameters and to size the cells. During the count the pro-
cessor is checking the analysing process for any irregularities. Size distributions
are printed for all populations (RBC, PLT and WBC).
The instrument has as standard a parallel and a serial output, which is user pro-
grammable. From a built-in selectable program the user can choose between dif-
ferent print formats.
A bar-code reader (scanner), available as an option, can be connected to enter the
sample ID automatically.
The instrument is fully automatic, which means that, the system is always pow-
ered on and performs automatically preforms check- and cleaning cycles to min-
imize user maintenance. Important
Applicable for CA620-
Note:
CellGuard:
PCT, LPCR, RDWa and PDWa are not established parameters. Their use should
be restricted to research or investigational use only. The MPA is intended to be
used for pre-donor screen-
2.3 Short-List of Specifications ing. Using the MPA for
PLT concentrate may re-
Measuring principle Impedance duce the accuracy of the
RBC, WBC, PLT result.
Measuring principle HGB Cyanide free method 540nm
Discriminator Floating programmable
Sampling system Closed shear valve
Parameters reported RBC, MCV, HCT, PLT, MPV HGB, MCH,
MCHC, WBC,
RDW%, LYMF abs, MID abs, GRAN
abs., LYMF%, MID%, GRAN%
RDW abs, PDW abs, LPCR, PCT
Size distributions printed for RBC, PLT and WBC diff.
Aspirated blood volume approx. 125µl
(open tubes)
Aspirated blood volume approx. 200 µl
(closed tubes)1
Blood volume using the 20 µl
Micro Pipette Adapter
Pre-diluted mode 1:200 to 1:250 using min. 20µl blood
e.g. 20 µl to 5 µl diluent
30 µl to 6 µl diluent
40 µl to 8 µl diluent
CA530 Screen 2x40 character LCD
CA620 Screen Graphic LCD display
Keyboard Numerical
Total cycle time approx. 73 seconds

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 Specifications

Sample display and print after approx. 53 seconds

Printer External, IBM proprinter, Epson format,
HP-PCL or DPU411-type II /DPU414
supplied by Boule-Medical
CA530 Memory >350 samples
CA620 Memory >200 samples and 600 control samples
CA530 QC capability SD, CV, Xm
CA620 QC capability SD, CV, Xm, Levey-Jennings plots and
X-B with approx. 10.000 samples history
HGB correction on high Yes
WBC counts
Warning flags on parameter abnor- Yes
malities
Floating discriminator RBC/ PLT Yes (position printed)
Mathematical 3-part diff. WBC calc. Yes
Automatic HGB blank on each Yes
sample
Carry Over < 1%
Bar-code reader input Yes
Serial output2 Yes
Mains voltage / Fuses 230V Fuse 5x20mm T2A
120V Fuse 5x20mm T4A
Mains voltage tolerances +15% / -15%
Power consumption max 250 VA
Power consumption (stand-by) max 50 VA
Frequency 50/60 Hz
Built-in test /adjustment programs Yes
Temperature 18-32C, 64 - 90F
Humidity (none condensing) 20-80%
Dimensions H= 350,W=420, D=460 (mm),
H= 13.8, W=16.5, D=18.1 (inch)
Weight (net) approx. 22 Kg, 48.5 Lbs
1. Optional device
2. Computer & connection must conform to standard EN 60950

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 Specifications

2.4 Parameter Ranges

Linearity +/-1% within the following range:
WBC 0.5 - 80.0
RBC 0.5 - 9.99
MCV 55 - 130
PLT 30 - 999
HGB 0.5 - 55.0
PLT-Concentrate mode 30-6999
(RBC < 0.3 and measured on a Latex (applicable on CA620-Cellguard only)
solution)
Measuring range:

WBC 0 - 99.9
RBC (CA620-Cellguard) 0 - 13.99
RBC (CA620/530) 0 - 13.99
MCV 15 - 250
PLT 0 - 6999
HGB 0 - 99.9
PLT Concentrate mode 0-6999
(applicable on CA620-Cellguard only)
Correlation1

RBC, WBC R > 0.97

PLT R > 0.90
HGB R > 0.99
MCV R > 0.90
Reproducibility (typical):

Measured as an average of 10 measurements each of 10 different vein K2-

EDTA collected normal samples:
Parameter X-mean (CGS units) CV(%)
WBC 7.4 2.0
RBC 4.52 0.85
MCV 89.4 0.5
PLT 252 3.2
HGB 13.9 0.8
1. Using Coulter AcT and Abbot CD1600 as reference

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 Specifications

2.5 Reagents and Reagent Consumption

The reagent consumption is depending on the total number of samples/day. Us-
ing the system for more than ca. 50 samples/day; the reagent consumption will
be:
Caution
Use only by Boule autho- Diluent approx. 19 ml/sample
rized reagents.
Lyzer approx. 9.5 ml/sample
Erroneous results and
damage of the system may The approximate consumption can be calculated from the graph below and is de-
occur if other reagents are pending on the number of samples/day. The figures stated are indicative only and
used. assumes maximum 2 “blank” counts per day. As seen from the graph, the relation
Diluent/Lyzer is 2:1 in case of 50 samples/day or more. Hence, using the instru-
ment for less number of samples/day, less Diluent is consumed in relation to the
lyzer

Diluent consumption CA620 vs # samples

Diluent consumption / sample

35
30
25
20
(ml)

15
10
5
0
0 50 100 150 200
Number of Blood_samples/Day

1014.eps

Diluent Consumption

Lyzer consumption CA620 vs # Samples

20
18
Lyzer consumption /

16
sample (ml)

14
12
10
8
6
4
2
0
0 50 100 150 200

Number of Blood_samples/Day

1015.eps

Lyzer consumption

For additional information regarding cleaning solutions; please refer to Mainte-

nance, Shut-Down & Transport on page 95.

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 Specifications

2.6 Limitations
Verification of any abnormal test result (including flagged results or results out-
side of the normal range) should be performed using reference methods or other
standard laboratory procedures for the conclusive verification of results. The sec-
tion below list known limitations of automated blood cell counters in general as
well as specific issues for cell counters using the impedance technology.

WBC White Blood Cells (Leukocytes)

WBC that exceeds the linearity limits of the system will require dilution of the
blood sample. Re-assaying the diluted sample will help to obtain the correct assay
value.

NRBC
Immature Nucleated Red Blood Cells will be counted in the WBC parameter. If
the number of the NRBC is sufficient to activate the DE alarm, such interference
will be detected. However, the manual differential blood cell count, performed
on a stained blood film, will reveal the presence of NRBCs.

Unlyzed Red Cells

In particularly rare instances, the RBC in the blood sample may not completely
lyze. These non-lyzed cells may be detected on the WBC histogram with a DE
alarm or as an elevated baseline on the side of the lymphocyte population. Non-
lyzed RBCs will cause a falsely elevated WBC count. (See also NRBC above)

Multiple myeloma
The precipitation of proteins in multiple myeloma patients may give elevated
WBC counts.

Hemolyzis
Hemolyzed specimen contains red cell stroma (debris), which may elevate the
WBC and/or PLT count.

Leukemias
This disease state may result in a spurious low WBC count because of the pos-
sible increased fragility of the leukocytes leading to some destruction of these
cells during counting. The cell fragments will also interfere with the white cell par-
tial differential parameters (LYMF, GRAN and MID). A spurious low WBC
count may also be seen in patients with lymphocytic leukemias due to the pres-
ence of abnormally small lymphocytes, which may not be counted by the instru-
ment.

Chemotherapy
Cytotoxic and immunosuppressive drugs may increase the fragility of the leuko-
cytes, which may cause low WBC counts.

Cryoglobulins
Increased levels of cryoglobin that may be associated with myeloma, carcinoma,
leukemias, macroglobulinemia, lymphoproliferative disorders, metastatic tu-
mours, auto immune disorders, infections, idiopathic disease, aneurism, pregnan-
cy, thromboembolic phenomena, diabetes etc. and may cause elevated levels of
WBC, RBC or PLT counts as well as HGB. The specimen can be warmed up to
37°C and re-analysed immediately or a manual WBC, RBC or PLT count can be
performed.

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 Specifications

RBC Red Blood Cells (Erythrocytes)

The red blood cell dilution contains all the cellular elements of the blood, RBC,
WBC and PLT. During the counting platelets, are not counted since the size falls
below the threshold (discriminator). Leukocytes however, are always included in
the RBC count. Since the concentration ratio between RBC and WBC is normally
ca. 1000, the introduced error is almost negligible.
In case of high WBC counts with low RBC, the RBC count may be corrected by
simply subtracting the WBC from RBC.

Agglutinated red blood cells

This might cause a falsely decreased RBC count. Blood samples containing the
agglutinated red blood cells may be identified by observing abnormal MCH and
MCHC values as well as by examination of the stained blood film.

Cold agglutinins
IgM immunoglobulins which are elevated in cold agglutinin disease may lower
RBC and PLT counts and increase the MCV.

HGB (hemoglobin)
Turbidity of the blood sample due to any number of physiological and/or thera-
peutic factors may produce falsely elevated HGB results. The CA620/530 how-
ever is compensated for this effect with high WBC counts up to WBC approx. 60
10e3/µl. In case of extreme WBC counts, the following is recommended:
1. Elevated WBC
The diluted sample should be centrifuged and the supernatant fluid checked
on a spectrophotometer for turbidity.
2. Elevated lipids
Elevated lipids in the blood sample will give the plasma a “milky” appear-
ance. This condition can occur with hyperlipidemia, hyperproteinemia and
hypobilirubinemia. Accurate HGB determination can be achieved by using
reference methods and a plasma blank.
Increased turbidity may also be seen in cases where the red blood cells are resis-
tant to lyzing. This condition will cause a falsely elevated HGB result but can be
detected by monitoring the MCHC.

Fetal blood
The mixing of fetal and maternal bloods may produce a falsely elevated HGB val-
ue.

HCT (Hematocrit)
As HCT is the product of MCV x RBC, any erroneous result in MCV and/or
RBC will produce an equal error in the HCT parameter.

Red blood cell agglutination

May produce an erroneous MCV value and therefore a false HCT

WBC
An excessive number of WBCs might cause interference within the RBC popula-
tion and therefore a false MCV value.

PLT
Excessive numbers of PLT, in most cases, do not interfere with the MCV param-
eter due to the use of the floating discriminator technology in the instrument.

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 Specifications

RDW (Red Cell Distribution Width)

The red cell distribution width is a function of the RBC count and derived from
the RBC histogram. In most cases, any error introduced in the MCV may also
cause the RDW to be erroneous. Especially blood transfusions may raise the
RDW significantly due to the presence of bi-modal populations.

PLT (Platelets or Thrombocytes)

Very small RBCs might elevate a PLT count. This effect is minimized in the in-
strument due to the use of a floating threshold (discriminator). By observing the
PLT and RBC histograms, this effect is seen as an overlapping PLT/RBC area.

Agglutinated RBCs
Agglutinated RBCs might trap platelets and may give an erroneous low PLT
count. The presence of agglutinated RBCs is detected by monitoring the MCHC
parameter and by careful examination of the stained blood film.

Giant platelets in excessive numbers

This may cause a low PLT count since they might fall within the RBC threshold
range.

Chemotherapy
Cytotoxic and immunosuppressive drugs may increase the fragility of these cells,
which may cause low PLT counts. Reference (manual) methods may be necessary
to obtain an accurate platelet count.

Hemolyzis
Hemolyzed specimens contain red cell stroma, which may elevate platelet counts.

A.C.D. blood
Blood anti coagulated with Acid Citrate Dextrose may contain platelet aggre-
gates, which could depress the platelet count.

RBC inclusions
Erythrocyte inclusions may also produce a spuriously increased platelet count.
(e.g. Howell-Jolly bodies, siderotic and basophilic granules)

Platelet agglutination
Clumped platelets due to poor collection techniques or platelet satellitosis caused
by EDTA activation of immunoglobulins may cause a decreased platelet count
and/or an elevated WBC count. The specimen should be recollected in sodium
citrate anticoagulant and re analyzed for only the platelet count. The final PLT
result must be corrected for the sodium citrate dilution effect.

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 Specifications

MPV (Mean Platelet Volume)

Giant platelets
Large platelets counted as RBCs will fall outside the PLT range and therefore
lower the MPV.

Small erythrocytes
Very small RBCs might fall into the PLT region and might be counted as PLTs
and therefore influence the MPV parameter. (This effect is minimized in the in-
strument due to its floating threshold system)

Agglutinated erythrocytes
This may trap platelets and therefore affect the MPV parameter. Note that agglu-
tinated erythrocytes may be detected by carefully examine the MCHC parameter
and/or the stained blood film.

Chemotherapy
May also effect the size of the PLTs

EDTA
Note that all samples collected in EDTA will not maintain a stable MPV. The
PLTs will swell as a function of time and temperature.

LYMF (Lymphocytes)
The lymphocyte count is derived from the WBC count. The presence of nucleat-
ed red cells (NRBC), certain parasites and erythrocytes that are resistant to lysis
may interfere with LYMF count.

MID (MID sized area)

The mid size area consists mainly of Monocytes. The presence of large Lympho-
cytes, atypical lymphocytes, blasts, and excessive number of basophils may inter-
fere with the MID area.

GRAN (Granulocytes)
The granulocyte cell count is derived from the WBC count. The presence of ex-
cessive numbers of metamyelocytes, myelocytes, promyelocytes, blasts and plas-
ma cells may interfere with an accurate granulocyte count.

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 Specifications

2.7 Differences between CA620 and

CA530 (9,16,20 parameters)
The CA620 and CA530 have identical parameter performances in all respects.
The differences are the following:
• -The INTRA mode, see section Analysing the Sample (Open Tube) on
page 54 and “Block parameters” see section Block parameters on page 72
are not available on the CA530.
• The CA620 has an extended calibration menu, see Calibration Through a
Certified Calibrator on page 83.
• The CA620 has an extended QC function including X-B and Levey-Jen-
nings Plots. See Introduction on page 87.
• The CA530 employs a 2 x 40 alphanumeric display and the CA620 is
equipped with a graphic display making, a graphic display of the size-distri-
bution curves, possible.
• Extended print format is available on the CA620 only.
See appendix 530-30-205 available from your authorized distributor.
• The CA620-CellGuard can be configured as a donor screening device or as
a tool to determine the PLT concentrations in PLT bags. In case the instru-
ment is used for donor screening, it is fully identical to a CA620 16 param-
eter machine.
• The CA620 differs from the CA530 by the specially designed front panel
and keyboard.

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 Specifications

The menu numbering for the CA620, CA620-CellGuard and CA530 is identical.
This user manual is therefore applicable for both type of instruments.
The following table shows which parameters are available on the 9, 16 and 20 pa-
rameter models:
CA530- CA530- CA530- CA620- CA620-
9 16 20 16 20

RBC yes yes yes yes yes

MCV yes yes yes yes yes
HCT yes yes yes yes yes
WBC yes yes yes yes yes
HGB yes yes yes yes yes
PLT yes yes yes yes yes
MPV yes yes yes yes yes
MCH yes yes yes yes yes
MCHC yes yes yes yes yes
RDW% no yes yes yes yes

LYMF% no yes yes yes yes

MID% no yes yes yes yes
GRAN% no yes yes yes yes
LYMF no yes yes yes yes
MID no yes yes yes yes
GRAN no yes yes yes yes

RDWa no no yes no yes

PCT no no yes no yes
PDW no no yes no yes
LPCR no no yes no yes

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 Specifications

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 3 Measuring Principles
3.1 RBC,WBC and PLT Concentration
Detection
Detection is accomplished using the electronic impedance principle and occurs
in the orifice of the transducer.
The blood is diluted to 1:400 (WBC & HGB) and 1:40000 (RBC & PLT) through
a precise shear valve system. The shear valve (sampling valve, marked in the figure
below) “cuts” a very reproducible volume (25 µl) from the aspirated blood and
dilute with an equal precise volume of diluent (or lyzer) to achieve the final dilu-
tion rates.

Sampling valve

1017.wmf

Two separate measuring chambers and transducers are used, one for RBC/PLT
and one for WBC/HGB analysis. This excludes any possibility of cross contam-
ination between the lyzer and the RBC/PLT dilution.
A pressure is applied on top of the diluted sample and the diluted sample is
pressed through an orifice (aperture) of 80 µm diameter. Each side of the orifice
is equipped with a platinum electrode and an electrical current is applied between
the electrodes.
When a cell is drawn into a constant current, flowing from an electrode through
the orifice to a second electrode, the electrical conductivity changes. This gener-
ates an equivalent voltage pulse.
The amplitude of the pulse is directly proportional to the volume of the repre-
sented cell. The number of pulses corresponds to the number of cells detected.
Coincidence corrections are made within the software of the instrument, giving
the instruments a full linear range within the specifications.

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 Measuring Principles

electrical current

electrodes

cells

Flow direction

A=Aperture 1018.tif

The PLT, RBC and WBC parameters are measured on a precise aliquot of the
sample. The amount of sample measured is determined by the volume of a pre-
cise glass column; called a metering tube. Two optical detectors are used to start
and stop detection.
The start detector is activated by the flow of the isotonic diluent through the me-
tering tube. As the meniscus passes the optical path it causes a voltage change that
activates the count and sizing circuitry of the system.
As the isotonic diluent continues to flow upward into the metering tube it passes
the stop detector. This action stops the count and analysing process and the pa-
rameters and distribution curves are displayed (and automatically printed if so
programmed by the user). Due to this principle, the CA instruments perform ab-
solute counts related to fixed volumes.
glass tube

stop detector

flow fixed volume

start detector

1019.tif

The instruments use a lower discriminator level at approx. 2.5 fl. All cells over this
level are analyzed and the counts are stored. The user defines, by means of setting
the discriminator level(s), which cell is seen as a PLT or as a RBC cell. A red blood
cell is defined as a cell with a volume larger than the upper PLT programmable
discriminator level.

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 Measuring Principles

All cells smaller than the upper PLT discriminator level will not be recognised as
red cells. In case the user has selected a “floating” discriminator; RBC cells are
counted from the set-point of this variable discriminator, which varies from sam-
ple to sample between the volume limits set by the user.
The number of cells for determining RBC is counted from a suspension of
1:40 000 dilution ratio of whole blood.
Let us suppose that a sample contains 5 000 000 cells/µl. A dilution of 1:40 000
then give a final concentration of 5 000 000 divided by 40 000 = 125 cells/µl, so
each µl drawn through the aperture generates 125 pulses.
The measured volume drawn through the aperture is 270 µl (factory calibrated),
so the system will count 270*125 = 33 750 pulses. The analyzer uses a fixed divi-
sion factor of 67.5, so the display will show 33 750/67.5 = 500, which is the cor-
rect value.
With the size of the orifice and the concentration of cells, there will be a certain
coincidence in the orifice system. However this is a constant system factor and
compensated within the software by a correcting algorithm to make the RBC
count linear within the stated specifications.
Hence, the total number of cells passing through the aperture when determining
the RBC is the value on the display multiplied by the factor 67.5. Therefore, a
sample which gives 5.00 in the RBC display field has been analyzed by measuring
500 * 67.5 = 33 750 cells.
The reproducibility is directly related to the total number of cells entering the or-
ifice. The higher the concentration, the better the reproducibility. The instrument
has a dilution ratio for RBC of 1:40 000 and the CV will therefore be less than
1% for samples with an RBC number within the normal range.

3.2 Sizing RBC, WBC and PLT

The sizing is done in a matrix with the volume on the horizontal (x-) axis and the
number of cells on the vertical (y-) axis.
(The x-axis is divided into 2048 channels)
As stated above, a size distribution is performed for both PLT and RBC simulta-
neously. The 'RBC' distribution however, is the distribution with a higher volume
than the upper discriminator level which is marked on the display and printer as
a dotted vertical bar.
The maximum (RBC) cell size that can be analyzed is 250 fl. Clumps of cells larg-
er than this volume are analyzed as being 250 fl and are 'collected' in the highest
channel.
As the curves are 'normalised', the height of the distribution curve is not neces-
sarily related to the number of RBC cells counted.
The reproducibility of the curve is also dependent upon the concentration of cells
in the sample.
In cases with a low number of RBC cells there might be some slight differences
in the shape of the curve from one count to another due to statistical sampling.
Sizing of the WBC population is done simultaneously in an equal second matrix.
The highest “channel” represents a volume of ca. 400 fl. As with the RBC/PLT
sizing, the reproducibility of the curve is dependent upon the concentration of
(WBC) cells in the dilution.

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 Measuring Principles

3.3 Counting Time RBC & WBC

The microprocessor system checks the counting time for the RBC and PLT
counting process. The counting time is defined as being the time needed for the
sample to be drawn from the start- to the stop detector in the metering unit. See
RBC,WBC and PLT Concentration Detection on page 25.
A counting time, which is 'HI', may be caused by a blockage in the aperture. In
such case, the system rinses the aperture (orifice) automatically. It is advisable to
check the counting time by using isotonic diluent as a new sample. (To save the
original blood sample).
The counting time limits on the RBC/PLT process are 10.5 and 17.5 seconds re-
spectively. Normal counting time is 13.5+/- 2 seconds. If the counting time is
outside the limits, the text “LO” or “HI” will be displayed.
The counting time can be displayed using the left/right arrow keys and is shown
as:
- RBC-Time=
- WBC-Time=

Note:
The 'Counting time' is not related to the actual result. Atmospheric pressure vari-
ations, protein built-up within the orifice (aperture) and other secondary effects
that might cause pressure changes will NOT influence the counted parameters
RBC, PLT and WBC.

3.4 WBC Differentials

Within the 3-part diff. technology a general problem is found how to define the
correct settings of the discriminators for the lymphocyte, MID sized cell (mainly
Monocytes) and Granulocytes areas. Many analyzers are using a fixed discrimina-
tor analogue where fixed thresholds are used to separate the 3 populations. The
3 part. diff. technology is based on the reaction of the lyzer reagent(s) to each spe-
cific cell type. Lymphocytes are more lyzed compared to the Granulocytes, result-
ing in 2 main populations whereof the Lymphocytes will be the smallest.
The main problem is related to the Granulocyte population. The cytoplasma sur-
rounding the cells is slowly dissolved in the surrounding plasma in whole blood.
This means that the Granulocyte population is slowly collapsing and finally inter-
feres with the Lymphocytes.
Refer to the figure below where the same sample is analyzed after approx. 4, or
more, hours. It is clearly seen that a fixed discriminator technology is unreliable
whenever analysing blood exposed to time, high temperature or other factors that
reduce the cytoplasma surrounding the Granulocytes.

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 Measuring Principles

n
4 hours old
fixed discriminators

fresh” blood

LYMF GRAN

Volume (fl)

1020.tif

To overcome the above mentioned problem, the instrument utilizes a so-called

mathematical differential, where the curves are analyzed within the software and
3 separate curves are built through a curve fitting method.
Hence, the software of the instrument is building an artificial matching distribu-
tion around the main populations. To do so, after the analysing process, the in-
strument finds 2 main modes (= peaks) within the total distribution. Then
matching of the 2 main populations takes place including extrapolation to the
base line. The remaining area that was not covered by the 2 main populations is
now classified as being the MID cell area which mainly consists of the Monocytes.
A third population is now calculated, representing this area.
The final picture below consists of 3 curves and will be printed exactly this way.
It is obvious that this approach is not dependent on the actual position of the 2
main populations and therefore superior to a system using a fixed discriminator
technology.

MID cells

LYMF GRAN

Volume (fl)

1021.tif

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 Measuring Principles

3.5 MCV (Mean Cell Volume RBCs)

The MCV parameter is derived from the RBC distribution curve. As the distribu-
tion curve has a maximum volume range of 250fl, the maximum channel also
contains clumps of cells that are larger than this volume. Therefore this channel
is excluded from the MCV calculation. The MCV is calculated from the volume
position of the discriminator to 249 fl. Be aware that the discriminator might be
“floating” or fixed by the user in menu 5.6.x.
In general, RBC counts that are lower than 0.60 (displayed value) do not give a
MCV/HCT value due to low statistical significance.
If the MCV is calibrated by using the “Calibration” program, found in the “Set-
up” menu; the whole curve is recalculated and moved in a correct way that re-
flects the new calibration setting. The printed curve will therefore always be cor-
rect in respect to the actual MCV value.

3.6 RDW% (Red Cell Distribution Width)

The RDW% parameter is calculated from the RBC distribution curve. The CV of
the curve is calculated. However, the CV is only calculated on a portion of the
curve. This avoids that other populations might interfere. The RDW% value is
therefore only measured on a portion of the RBC size distribution curve. I.e. not
all particles are included in the RDW% calculation.
The RDW% parameter is only valid if the MCV value is not zero.

3.7 RDWa (Red Cell Distribution Width

Absolute)
The RDWa parameter (absolute) is calculated from the RBC distribution curve at
a fixed level. In contrast to the RDW% parameter, which is expressed in CV, the
RDWa parameter measures the absolute width of the curve. The RDWa parame-
ter is only displayed if the MCV value is not zero. The RDWa parameter is for
investigational purposes only. No “normal” ranges are given.

3.8 HCT (Hematocrit)

The HCT is defined as being the packed volume of red cells in whole blood and
is calculated through MCV * RBC.
If no MCV is derived from a sample due to too low a number of RBC cells, no
HCT is calculated.

3.9 PLT (Platelets)

Platelets are defined (for the purpose of discrimination) as cells in a range from
2.5fl to the discriminator level that is either set on a fixed volume or “floating”
and determined by the software on each sample. The setting of the upper discrim-
inator is done in the set-up menu 5.6.
The platelets are determined from the same dilution as the RBC, in fact, the sys-
tem is counting just “cells” during the RBC/PLT counting process. The determi-
nation of which cell is a PLT or RBC is done at the end of the counting procedure
and fully determined by the setting of the user defined discriminator behaviour
(floating or fixed).

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 Measuring Principles

Let us suppose that a sample contains 200 000 platelets/µl in whole blood. After
a dilution of 1:40 000 the sample contains 200 000 divided by 40 000 = 5 cells/
µl. So, each µl drawn through the aperture gives 5 pulses. As the counting volume
(the volume of the metering glass tube) is 270 µl, the total number of cells that
are analyzed will be 5*270=1350 cells.
In other words, the total number passing through the orifice when determining
the PLT is the value shown on the display screen without decimals multiplied by
the factor 6.75.
The reproducibility is directly dependent on the total number of cells entering the
orifice. In the instrument, measuring PLT from the same dilution as RBC, the CV
will be less than 3.5% for most of the samples within normal range. The CV will
be lower for most samples, but on some samples it might be slightly higher. A
'mean' CV of about 3.2% is expected for well-treated fresh EDTA whole blood
samples within the range of 200-350 103/µl. As the system uses an orifice size of
80 µm diameter, coincidence losses will take place with extreme sample RBC/
PLT counts. The system has a software with a well-balanced mathematical cor-
rection algorithm to minimize these effects
Please note that if a floating discriminator is used and no well-defined minimum
is found between the RBC and PLTs, the reproducibility of mainly the PLT is af-
fected. To check the reproducibility of the low PLTs, it might be wise to put the
analyzer in a fixed discriminator mode to exclude any error introduced by an ill-
defined RBC-PLT population.

CA620-CellGuard PLT (Platelets)

In case the CA620-CellGuard is programmed and used for PLT concentrates, the
reproducibility is better than the stated CV figures above, as CV is a concentra-
tion dependent parameter.

Note:
In case high numbers of RBCs are present using the PLT concentrate mode, PLT
will show a flag “RP” (Red cells Present) to warn the operator that the PLT pa-
rameter may not be correctly analyzed.

3.10 MPV (Mean Platelet Volume)

The mean cell volume of the platelets is determined from the PLT size distribu-
tion curve.
The MPV is defined as being the mean value of the PLT size distribution curve
from the lower discriminator (2.5 fl) to the position of the upper discriminator
which might be programmed as floating or fixed as set in menu 5.6.x.
MPV is not displayed in case of extreme low PLT counts due to high statistical
inaccuracy of such a population.

3.11 PDW (Platelet distribution width)

The PDW parameter is calculated from the PLT distribution curve at a fixed level.
The calulation of the PDW parameter is analogue to the RDWa parameter for
RBC.
The PDW parameter is only valid if the MPV value is not zero. This parameter is
for investigatory purposes only. No ‘normal’ range is supplied.

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 Measuring Principles

3.12 LPCR (Large Platelets)

The LPCR (Large Platelets Concentration Ratio) parameter is calculated from the
PLT distribution curve. Platelets that are larger than 12 fl up to the (floating) dis-
criminator are expressed in % of the total PLT count.
The LPCR parameter is only valid if the MPV value is not zero.

3.13 PCT (Packed Platelet Volume)

The PCT is calculated as being PCT= PLT x MPV and expressed in %.

3.14 HGB (Hemoglobin Concentration)

The hemoglobin is determined from the same dilution as the WBC. For each
sample a blank is measured as a reference, this means that any drift in reagent-
and cuvette-absorption or lamp is eliminated. The photometer system consists of
a tungsten lamp, a cuvette with a length of 15 mm and a filter at a wavelength of
535nm (bandwidth 20nm). The HGB readings are slightly corrected for turbidity
in case of extreme WBC counts. The lamp is switched off if the instrument is in
stand-by-mode, giving it an extended lifetime.

3.15 MCH (Mean Cell Hemoglobin)

The MCH is a calculated value and is defined as HGB/RBC giving the mean
HGB concentration in each red cell.

3.16 MCHC (Mean Cell Hemoglobin

Concentration)
The MCHC is a calculated value and is defined as HGB/HCT.
The MCHC is calculated from 3 measured parameters and therefore an excellent
instrument stability check. MCHC=HGB/HCT HGB/(MCVxRBC).
In general it could be stated that if a daily mean value is found outside the range
32-35 g/dl, the instrument might have been wrongly calibrated. The daily mean
value of the MCHC parameter should be 33.5 +/- 1.5 g/dl.

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 4 Parameter Flags
The instrument has several indication- and warning flags related to the measured
parameters. The flags are shown on the display as well as printed on the connect-
ed printer. An error flag should be seen as parameter value error. The sample
should be re-analyzed. A warning flag might indicate a pathological sample. If on
the same parameter both an error and a warning flag occurs; the error flag has
always a priority and is displayed and printed in the first place. Note that a param-
eter that is outside the “Normal Range” which is set in menu 5.4 is either marked
with “H” or “L” on the connected printer to indicate if the value is Higher or
Lower than the pre-set “Normal Range” values. The display will in such a case
show a “*” in front of the parameter value.

The following flags are seen as “Error flags” or “Warning flags”

Flag Cause Action Service call Comment
TU Blockage in aperture Re-run sample If persist See TU (Time-out Up-
per Detector) on page
34.
TL Blockage in aperture Re-run sample If persist See TL (Time-out Low-
er Detector) on page 34.
SE Irregular count Re-run sample See SE (Statistical Er-
ror) on page 34.
DE Interference between 2 Examine size distribution See DE (Distribution
populations RBC/PLT or WBC Error) on page 34.
FD Insufficient cell Examine size distribution See FD (Floating Dis-
separation RBC/PLT RBC/PLT criminator) on page 35.
OF HGB photometer Wait 15-30 minutes and If persist See OF (Offset error
offset out of range. restart instrument. HGB) on page 35.
LO HGB photometer lamp See comment If persist See LO (Low blank lev-
intensity too low el HGB) on page 35.
HI HGB photometer lamp See comment If persist See HI (High blank lev-
intensity too high el HGB) on page 35.
NG Negative HGB value Run “Prime” from menu If persist See NG (Negative
8.1 HGB) on page 35.
SE irregular HGB Re-run sample If persists on all sam- See SE (Statistical error
measurement ples HGB) on page 36.
TB Air bubbles in system Run ‘Prime’ from menu If persist See TB (Air bubbles) on
8.1 page 36.
NM, WBC differential abnor- Examine sample by refer- See NM, OM, TM, BD
OM, mality ence method (WBC Differential
TM, Flags) on page 36.
BD
RP Red cells present in PLT Disregard PLT See RP (Red Cells
concentrate (CA620-Cell- parameter result Present) on page 36.
Guard only)
EC Blood control expired Use new blood See EC (Expired con-
control trol) on page 37.

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 Parameter Flags

4.1 TU (Time-out Upper Detector)

The error flag TU might be displayed on the following parameters: RBC, PLT
and/or WBC. This error is related to the counting time. It means that the count-
ing time is outside the limits and displayed as “HI” or “LO”.

Note:
The instrument performs an auto-clean of the orifice after a TU is displayed; a
re-analyze of the sample might cancel this warning in most cases.
See Maintenance, Shut-Down & Transport on page 95. See also Trouble
Shooting on page 99.

4.2 TL (Time-out Lower Detector)

The error flag TL might be displayed on the following parameters: RBC, PLT
and/or WBC. If the system is unable to move the liquid level in the metering unit
up to the lower detector, this error is reported. No counting time is displayed in
this case. Most probably this is caused by a clogged aperture (orifice).

Note:
That the orifice is cleaned automatically and that in most cases a re-analyze of the
sample will cancel this clogging.
See Maintenance, Shut-Down & Transport on page 95. See also Trouble
Shooting on page 99.

4.3 SE (Statistical Error)

The error flag SE might be displayed on RBC/PLT /WBC and/or HGB.
During the analysing process, clumps of cells, partial blockages or other distur-
bances might affect the statistical accuracy of the displayed number of cells.
Therefore the analyzer checks the count/time ratio continuously and if this num-
ber/time ratio is strongly fluctuating, the parameter will be flagged with the SE
mark. 'SE' on the HGB parameter is related to an unstable extinction during the
blank and/or sample measurement.
Most probably the shown result will not be correct and the sample should be re-
analyzed.

See SE (Statistical error HGB) on page 36.

4.4 DE (Distribution Error)

This warning flag is related to the floating upper discriminator of the PLT size
distribution curve. The software analyzes the number of cells on the right-hand
side of the position of the upper discriminator in respect to the total number
within the size distribution curve. If a large population of cells is found in this
area, it usually means that no correct minimum can be found between the RBC
and PLT distribution. The reason for this might be an incorrect setting of the
floating discriminator or an incorrect setting of a fixed discriminator as done in
the “Discriminator set-up” in the set-up menu. However, on pathological sam-
ples with low PLT values this effect might occur even if the analysis is correct.
The PLT values are probably correct within 20% of the actual value. In case of
extremely low PLT values, this DE mark can be seen as a warning. In case of nor-
mal PLT values, it should be seen more as an error flag. A DE flag is also possible
on the WBC parameter. In such case the size-distribution curve is too far shifted
left, probably due to pathological sample. Another possibility is the presence of
aggregated PLTs, which might interfere with the LYMF region.

See Limitations on page 18.

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 Parameter Flags

4.5 FD (Floating Discriminator)

If the discriminator, between the upper volume of PLT and the lowest volume of
RBC, has been set as floating (see set-up menu) the instrument tries to find a min-
imum on the PLT / RBC curve. At this point, the floating discriminator will be
set. If no minimum can be found between the two limits that have been set in the
“discriminator set-up” menu; the floating discriminator will locate itself on the
limit where the lowest number of cells are found. This is a warning and NOT an
error flag. On low PLT values, where often a non log-fitting PLT curve is found,
this warning might occur frequently.

Usually, with correct settings of the discriminator limits, the PLT parameter is still
measured correctly.

4.6 OF (Offset error HGB)

Important This error flag is related to the HGB parameter only. During a “Power On” or an
Let the analyzer warm up exit from the Stand-by mode the offset voltage in the photometer system is mea-
ca. 1-2 hours and proceed sured. If the offset limits are violated, this flag is set. The ”OF” flag might also
with the installation proce- occur during the installation process. In such case, the analyzer was probably ex-
dure. In case the ‘OF’ flag posed to high temperature changes and condensation may have occurred.
persists, HGB values will
be incorrect. Call your au-
thorized service depart-
4.7 LO (Low blank level HGB)
This error flag is related to the HGB parameter. During each sample a blank is
ment.
measured as a reference, if the blank level is too low in intensity, due to a bad lamp
or a contaminated cuvette, the automatic blank adjustment cannot work reliably.
Go to the menu 6.2 an press digit [1]. The HGB photometer will now perform a
self-adjustment. This process takes ca. 5 minutes.
See HGB Value Flagged with LO on page 99.

4.8 HI (High blank level HGB)

During each sample a blank is measured as a reference, however if the blank level
is too high in intensity, due to a bad lamp or a previously cleaned cuvette, the au-
tomatic blank adjustment cannot work reliable. How to correct the HGB pho-
tometer See HGB Value Flagged with HI on page 100.

4.9 NG (Negative HGB)

This error flag is related only to the HGB parameter. During each sample a blank
is measured as a reference, however, if a sample has a lower absorption than the
measured auto-blank; this error flag is set. The reason might be:

a) Heavy fluctuations in stray light.

b) Strongly coloured lyzer-reagent.
c) No diluent or lyzer in the system or air bubbles.
To cancel this error, perform a ‘Prime’ from menu 8.1.

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 Parameter Flags

4.10 SE (Statistical error HGB)

This error flag is related to a statistical check that is made on the HGB parameter.
The blank and sample is measured 25 times and the SD is calculated from the
photometer output values. If the SD exceeds a certain limit, the SE flag is dis-
played on the HGB parameter.

The reason might be:

a) Bad mixing in the WBC/HGB cuvette.

b) Air bubbles or large particles in the cuvette.
c) Heavy mains disturbance (contact your authorized distributor).
In case this warning occurs occasionally, just re-analyze the sample.

4.11 TB (Air bubbles)

This error flag is related to the start detector. If during the raise of the diluent col-
umn in the glass tube, an air bubble should pass the start detector; this warning
is displayed.

To cancel this error, perform a ‘Prime’ from menu 8.1.

4.12 NM, OM, TM, BD (WBC Differential

Flags)
If no WBC Differential is displayed; the following warning flags are valid:

NM'No Mode'
No significant population was found. There is no valid 3 part WBC population.

OM'One Mode'
Only one population is found. This flag might be displayed in case of Granulo-
cytosis or Lymphocytosis or if the Granulocytes are collapsed into the Lympho-
cytes (old blood).

TM'Triple Mode'

There are more than 2 main populations. This flag might be displayed in case of
Monocytosis, heavy mains disturbance or wrong installation due to poor ground-
ing of the instrument and/or connected printer.

BD'Bad Distribution'

The LYMF and GRAN population are too overlapped. This flag is displayed if
the Granulocyte population is collapsed into the Lymphocyte area. The reason
might be:

• Old blood or extremely fragile Granulocytes

See Limitations on page 18.

4.13 RP (Red Cells Present)

This flag is only displayed in case the CA620-CellGuard is used for PLT concen-
trates. If the concentration of Red Blood Cells is > 0.3 in the PLT concentrate,
both RBC and PLT are flagged with 'RP' to indicate that Red Cells are present
and that the PLT value may not be correct.

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 Parameter Flags

4.14 EC (Expired control)

This warning is displayed in case a Boule certified blood control is entered and
the current date is more recent than the expiry date of the control.

Note:
The control must have been defined previously with the bar-code reader in menu
7.4.1.

4.15 Comments on Flagging Capabilities

All anomalies and/or abnormal distributions signalled by the instrument should
be verified manually for the presence of pathological elements. As a result of the
differences in stability towards lyzing of cytoplasmic membranes in the different
cell types, pathological elements can be found in a number of different zones.
This also applies to the presence of normal or non-pathological cells that have
been subject to chemotherapy or some other form of treatment. This might result
in false flagging. See Limitations on page 18.

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 Parameter Flags

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 5 Installation
5.1 Unpacking the Instrument
The instrument is packed as standard in a especially designed protective box.
Before the box is opened, check for any physical damages on the outside and no-
tify your carrier immediately in case of such.
Important
The following procedures Unpack the instrument and check that the following items are included:
must be followed exactly.
Boule has no responsibility List of materials included in delivery
in case of faulty or errone- ‰ Users Manual 1
ous installation. Possible
‰ Waste tube 1
errors that may occur are:
- Indication numbers ‰ Inlet tube with detector for Isotonic diluent. 1
- Erroneus parameter re- ‰ Inlet tube with detector for hemolyzing reagent. 1
sults
- Excessive service needs ‰ Mains cable 1
‰ Check that the instrument and the accessories are not physically damaged.
If there is any damage or accessories are missing, contact distributor and
carrier immediately.
‰ Installation checklist (to be sent back to the return ).

Warning List of materials not included in standard delivery

Electrical shock hazard ‰ Printer and printer- or computer connection cable.
Installation of external ‰ Printer paper.
electrical equipment such
as CVT must only be car- ‰ Additional software for patient sample managing systems.
ried out by authorized ser- ‰ Barcode reader.
vice engineers. Violating
this might result in injuries ‰ Reagents, blood controls, calibrators and cleaners.
and/or loss of life and/or
erroneous parameter re- 5.2 Working Conditions
sults.
Mains Supply Environment
The instrument should be operated at an indoor location only. The instrument is
designed to be safe for transient voltage as defined in IEC 801-4.
In case higher transient voltage, or mains voltage that exceed + 15% of the mark-
ing at the serial number plate are expected (e.g. within tropical areas), a CVT
(Constant Voltage Transformer, also called “Magnetic Stabilizer” or “Ferro-Res-
onant Transformer”) must be installed to protect the instrument against damage.
Warning Guidelines are given in the “Service Manual” section “Installation auxilliary de-
Electrical shock hazard vices”. Contact your authorized distributor in such a case.
The instrument must only An abrupt interruption of the mains supply will not damage the instrument as all
be connected to a ground- calibration constants and other parameters necessary for the correct working of
ed mains supply. Violating the instrument are protected against mains supply loss.
this, might result in injuries
and/or loss of life and/or
erroneous parameter re-
sults.

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 Installation

Location
The instrument should be placed on a clean and level table or work station. Avoid
exposure to sunlight. Make sure that the instrument has access to proper ventila-
tion and that at least ca. 10 cm free space must be left at the rear of the analyser,
marked as “A” in the picture below..
Place the instrument with easy access to the mains outlet and the mains cord. In
case that emergency shut-down is needed, due to an obvious malfunction of the
instrument and the instrument needs to be powered off follow the instructions
below:
1. Switch off the instrument immediately by:
Pulling out the mains cord from the mains supply.
2. Contact your authorized distributor’s service department immediately. Important
Operating the instrument
The instrument can work correctly within the stated temperature and humidity in an environment over
range however, to minimize the risk of bacterial growth in the reagent packages, +32°C (90°F) increases
it is strongly recommended to keep the laboratory at a temperature of approx. service-needs as well as
+22°C (72°F). degradation of sample
) specimen.

1178.bmp

Reagent packages
Reagent packages are preferably placed at the same level as the instrument (e.g.
the same table). In case such conditions cannot be met, place the Diluent con-
tainer at the floor level (maximum1 meter below the instrument level) but keep Warning
Contamination hazard
the Lyzer container preferably at the same level as the instrument (e.g. the same
table). Because no test method
can offer complete assur-
ance that HIV, Hepatitis B
Waste connection or C viruses, or other in-
The instrument has an open waste outlet and can be connected to a central waste fectious agents are absent,
system within the laboratory. The waste outlet, or container, must always be at a the waste should be han-
lower level than the instrument. National and/or local regulations must be fol- dled at the Biosafety Level
2 as recommended for any
lowed in all cases. infectious human blood
specimens in Protection of
Laboratory Workers From
Infectious Disease Trans-
mitted by Blood, Body
Fluids and Tissues- 2nd
Edition, Tentative Guide-
lines (1991) Document
M29-T2 promulgated by
the National Committee
for Clinical Lab. Standards
in the U.S.A. (NCCLS)

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 Installation

5.3 Mechanical Check and Set-Up

Recommendation
Installation of the instrument should be carried out by the authorized distributor.

Instrument installation
1. Lift the instrument and place it on the chosen location as shown below.
Be careful not to stress the front door of the instrument.

1023.tif

2. Open the front door of the instrument.

3. Locate the cover plate of the tubing system.

1024.tif

4. Unlock the screw at the left hand-side as shown below.

5. Lift up the screen slightly and remove it forwards.

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 Installation

6. Remove the grounding wire at the rear of the cover plate.

1025.tif

7. Remove all transport guides at the pinch valves. These guides are red co-
loured plastic clamps inserted in each valve. Save them for later use in case
of a re-installation.

Transport guides

Important
One valve is located be-
hind the pre-dilute start le-
ver MPA. Do not forget to
remove the transport
guides in this valve.
The instrument will not
1026.tif
operate correctly in case a
transport guide is not re-
moved. Possible conse-
8. Re-assemble the front cover in reverse order. Be sure to reconnect the
quences of not removing
ground-wire!
all transport guides are:
Reagent pack installation Indication numbers, incor-
1. Place the reagent pack in the proper place. See Reagent packages on page rect parameter results and/
40. or incorrect counting
2. Put the probes as shown below (the example shows the lyzer container). times.

1027.bmp

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 Installation

3. Locate the reagent inlets at the rear of the instrument, see picture below.

1028.tif

4. Connect the corresponding tubes from the reagent probes and the level de-
tector cables as shown in the picture below.

Caution 1029.tif
Bio hazard
The end of the waste tube 5. Connect the waste outlet to a proper container or open drain.
must be at a lower level See Waste connection on page 40.
than the instrument itself.
Final set-up
Not following this might 1. Locate the serial number plate at the rear and check that the mains voltage
lead to improper instru- and frequency corresponds to your local mains supply outlet.
ment functions and/or
waste liquid flowing back- 2. Insert the power cable and connect to the mains supply. A short beep is
wards into the instrument. heard where after the instrument will perform a self-check that normally
takes 2 minutes. (Maximum15 minutes in case of condensation).

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 Installation

Printer installation (optional)

In case the DPU411-type II/DPU414 printer is used as supplied through Boule,
connect the printer to the print outlet as shown below.

1030.tif

Follow the instructions as shown in the DPU411-type II/DPU414 user manual

how to insert paper and how to set the printer 'on-line'
In case an IBM compatible printer Epson or HP printer is used, please refer to
Printer and Serial Output on page 93.

5.4 Front Panel and Command Keys

The front panel of the instrument consists of:
1. Numerical keyboard
2. Display
3. [Print]
4. [Menu] button
5. Arrow keys,
1

3
4

5
1031.tif

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 Installation

Using the keyboard

Numerical keys are used to enter ID, calibration factors, normal ranges and other
entries that need numerical identification.
[CE] always clears a previous entry unless the [Enter] validation key has been
pressed.

1032.tif

[Print] will send the sample data to either the printer and/or serial output, de-
pending on how the instrument is configured by the end-user.
[Menu-Operate] is used to switch between Menus and the operational mode. The
operational mode is defined as the instrument status where the next sample can
be entered at the aspiration pipette.

1033.tif

The arrow keys are used to scroll through the Menu system, switch between dif-
ferent display modes and to display alternative parameters. The right arrow key is
also used to enter either a + or a - within the calibration menu.

1034.tif

Note that the [Power-On] indicator is an indicator only and no key!.

1035.tif

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 Installation

Note:
Aspiration command keys are not located on the keyboard. Aspiration of a sam-
ple is started by pressing the start-lever behind the aspiration needle.

5.5 Filling the system with reagents

After power-on, the instrument will perform a self-check which lasts for ca. 2
minutes. During this period, no key entry is accepted by the instrument.
1. Press [Menu]until the main menu is displayed on the LCD screen.
2. Scroll with the up-arrow key to 8 and press [Enter].
3. Scroll to 8.2 and press [Enter].

1036en.gif 1037en.gif

The system is now filled with reagents. This cycle lasts for ca. 6 minutes.
When the system is finished with this cycle, the cursor field returns to the field
8.2. Press [Menu] to return to the main menu.

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 6 Initial System Configuration
6.1 CA620-CellGuard
The CA620-CellGuard is configured as default in blood mode, in other words; as
a pre-donor screening instrument.
The end-user however, must decide if the CA620-CellGuard is used for pre-do-
nor screening or if it is mainly used to monitor PLT concentrates. Default settings
of the instrument can be printed out after the installation procedure by selecting
menu 5.9.

6.2 Setting up the CA620-CellGuard

for Pre-Donor Screening
The CA620-CellGuard used for pre-donor screening accepts whole blood at the
open aspiration pipette, micro capillary collected blood through the MPA device
or pre-diluted blood entered at the pre dilute aspiration probe.
In case the optional cap-piercing device is installed, closed tubes can be entered
as well.
Normal range values, floating discriminator settings are set as default to the most
common and correct settings.
All available parameters are set as default to be reported on the LCD screen as
well as on the connected printer. Hence, no extra settings are needed except that
the instrument is programmed to default in 'blood mode'
To do so:
Press [Menu] until the main menu is displayed.
4. Scroll with the up-down arrow keys to line 5 [Set up].
5. Press [Enter].
6. Scroll to line 5.8.
7. Press [Enter]
8. Press digit [1]
9. Press [Enter].
This sets the CA620-CellGuard to blood operational mode as default and the
configuration is identical to the CA620.

1038en.gif 1039en.gif

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 Initial System Configuration

6.3 Setting up the CA620-CellGuard

for PLT Concentrate
The CA620-CellGuard used as a monitor for PLT concentrates, accepts the sam-
ple at the open aspiration pipette.
Normal range values andl floating discriminator settings are as default the most
common and correct settings.
Parameters that are not valid are as default blocked from the display (e.g. HGB
and related parameters are not displayed and printed). Hence, no extra settings
are needed except that the instrument must be programmed as default in 'PLT
concentrate mode'.
To do so:
1. Press [Menu] until the main menu is displayed.
2. Scroll with the up-down arrow keys to line 5.
3. Press [Enter]
4. Scroll to line 5.8
5. Press [Enter]
6. Press digit [2]
7. Press [Enter]
This sets the CA620-CellGuard to PLT concentrate operational mode as default.

1038en.gif 1041en.gif

6.4 CA620/530
The CA620/530 is configured as default to the most common use. This applies
to “Normal Ranges”, “Floating Discriminator Settings” and “Units”. Default set-
tings of the instrument can be printed out after the installation procedure by se-
lecting menu 5.9.
Menu 5.8 is set to ‘1’ as shown in Setting up the CA620-CellGuard for Pre-
Donor Screening on page 47.

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 Initial System Configuration

6.5 Setting Date and Time

1. Press [Menu] until the main menu is displayed and select menu 5.
2. Scroll to line 5.5.
3. Press [Enter]

1042en.gif 1043en.gif

As seen on the LCD screen, 4 different date formats can be set. For EU, set date
format 0, for the U.S. set date format 2.
1. Use the up-down arrow keys to scroll to the date format field.
2. Enter the correct setting.
3. Scroll to the line “Date'” and enter the correct date using the previous set
date format.
4. Scroll to the line “Time” and set the correct time in 24 hours notation.
In case a different date separator is required:
1. Scroll to the line “Date separator”.
2. Press [Enter]
From the following menu, different “date separator” signs can be chosen.
3. Use the scroll arrow keys to select.
4. Press [Enter] to validate.

1044en.gif

6.6 Printer Configuration

In case a printer is connected to the instrument, which is strongly recommended,
the print command as well as the print format needs to be set.
1. Press [Menu] until the main menu is displayed. See below.

1045en.gif

Point 2, 3 and 4 describes the settings of the print commands and format.

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 Initial System Configuration

Make sure that the printer is connected and put on-line.

2. Scroll to line 2.
3. Press [Print]
A list is printed with several options. In case an automatic printout after each sam-
ple is required including the size histograms:
4. Select 2
5. Press [Enter]
Setting “0” will disable the auto-print of the instrument.
6. Scroll to line 3.
This entry selects what and where to print the parameter results if the [Print] key
is pressed.
7. Press [Print] again, an equal list is printed.
8. Select 2
9. Press [Enter] to activate the [Print] key function to print all parameters in-
cluding the histograms.
10. Scroll to line 4.
11. Press [Print]
A list is printed with available pre-programmed formats. In case a DPU411-type
II/DPU414 printer is connected (recommended) only formats can be chosen
which are indicated as 'DPU411'.
The print format function describes the order of parameters on the printout as
well as the font style. As default, format 8 is set (DPU).

1046en.gif

Note:
If no external computer is connected to the instrument, do not select settings 3-
8 on the Main Menu.
For detailed information regarding printers and printing options, please refer to
section Printer setup menu CA620 on page 73 and Printer and Serial Output
on page 93. For advanced printer options, refer to appendix 530-30-205 available
from your distributor (in English only).

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 Initial System Configuration

6.7 Select Language

The instrument can be programmed to show the displayed text in different lan-
guages, e.g. English, German, Spanish etc. (depending on program version).
To change language:
1. Scroll to “Setup menu” from the main menu.
2. Press [Enter]
3. Scroll (up) to “Setup menu2”.
4. Press [Enter].
5. Type the number corresponding to the selected language
6. Press [Enter] to validate to new setting. (e.g. # 1 = English)

1047en.gif

6.8 Select Units

The instrument has six different unit modes, based on SI- and CGS units. To
change, choose:
1. Select menu 5.10.2
2. Choose the required unit expression from the table below.

1048en.gif

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 Initial System Configuration

Select 1 2 3 4 5 6
number:
HGB expr g/dl mmol/l g/l g/l g/dl g/dl
HCT expr. % l/l % l/l % %
WBC 103/mm3 109/l 109/l 109/l 103/µl 109/l
RBC 106/mm3 1012/l 1012/l 1012/l 106/µl 1012/l
HGB g/dl mmol/l g/l g/l g/dl g/dl
HCT % l/l % l/l % %
MCV µm3 fl fl fl fl fl
MCH pg fmol pg pg pg pg
MCHC g/dl mmol/l g/l g/l g/dl g/dl
PLT 103/mm3 109/l 109/l 109/l 103/µl 109/l
MPV µm3 fl fl fl fl fl
RDW(CV) % % % % % %
RDWa fl fl fl fl fl fl
PDW fl fl fl fl fl fl
PCT % % % % % %
LPCR % % % % % %
LYMF 103 3
/mm 10 /l 9
10 /l9
10 /l9 3
10 /µl 109/l
GRAN 103/mm3 109/l 109/l 109/l 103/µl 109/l
MID 103/mm3 109/l 109/l 109/l 103/µl 109/l
LYMF% % % % % % %
GRAN% % % % % % %
MID% % % % % % %

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 7 Routine Operation
The instrument should always be connected to the mains supply and will auto-
matically perform an auto-checking/cleaning cycle every fourth hour. This
unique feature protects the instrument from bacterial growth, checks electronic
and mechanical settings automatically and eliminates virtually all user mainte-
nance.
If the instrument is not used within 45 minutes (no key has been pressed or no
sample has been run), the instrument will automatically enter a “Stand-by-mode”
1. Press [Menu] and the instrument is operational after the auto prime cycle is
finished.
2. Press [Menu] again to enter the operational mode and the last run sample
will be displayed. See pictures below.
In case the instrument was powered-on and menu 8.1 or 8.2 was chosen, the sam-
ple screen will display no parameter results.

1049en.gif 1050en.gif

1051en.gif

Applicable for CA620-CellGuard

The operation is identical if the system is programmed for pre-donor screening
or used as a PLT concentrate control, however, the displayed number of param-
eters will be different if used in PLT concentrate mode.

7.1 Background Check

The following sequence is performed to check that the background is low
enough, before each series of counts: Use isotonic diluent as the sample and as-
pirate by pressing the whole blood start lever which is located behind the whole
blood aspiration needle. Note that the aspiration time of diluent will be ca. 10 sec-
onds in case the CA620/530 is set up for normal use on blood specimen. The
CA620/530 applies a blood detector, which is an optical device that stops the
blood flow when blood is detected after the shear valve system. Therefore, run-
ning in “blood mode” and entering diluent as a sample, the system will time-out
after ca. 10 seconds and continue its cycle.

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 Routine Operation

The background should not be higher than the figures below, assuming that at
least 2 blanks are run after a sample.
( CGS units) (“Units =1”:

RBC 0.01
WBC 0.1
HGB 0.1
PLT 10

1052en.gif

7.2 Analysing the Sample (Open Tube)

Choose the operational mode with [Menu-Operate] so that the last run sample is
displayed.
Aspirate the sample through the aspirating pipette by pressing the start lever be-
hind the aspiration needle. See picture below.

Warning
Contamination hazard if
contaminated blood enters
into open cut.
Always wear protective
gloves when handling
blood samples.
1053.bmp
(Gloves in the picture are
The display shows the following sequences: not shown for clarity rea-
sons only.)
Last Sample (= blank) Aspirating sequence

1052en.gif 1055en.gif

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 Routine Operation

The instrument switches now to the following menu.

Important
Remove the sample from
the open inlet aspiration
needle when the display
1056en.gif
has changed from “Aspi-
rating” to “Counting cycle
Although not mandatory, enter the ID of the sample with the numerical keys.
in progress”.
Note that a positive identification of a sample is highly recommended to avoid
Not removing the sample
erroneous patient parameter reporting. A maximum of 15 digits are allowed in the
could result in incorrect
ID field. In case the optional Bar-Code reader is installed, simply scan in the ID
washing sequence of the
barcode from the sample tube.
aspiration needle.
After approx. 30 seconds; the CA620 will switch to the INTRA mode as shown
below:

1057en.gif

Note:
The INTRA mode is only available on the CA620-series
The display shows the counting rate on each counted parameter in real-time. The
horizontal lines in the “boxes” represent the parameter normal range as set for
PROG1 in menu 5.4.1, which is assigned to 'blood mode'. The drawn line during
the analysis is slightly irregular due to the counting statistics. However if the
drawn line is within the parameter limit lines, the sample is probably within the
normal range. In case the drawn line is outside the limits, the sample is probably
pathological. With this tool, the operator is alerted of a suspected pathological
case before the sample is analyzed completely. The vertical dotted lines represent
the expected normal counting time. See below.

Upper “normal” range setting

Rate

Lower “normal” range setting

1058.gif

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 Routine Operation

Sample displayed after ca. 53 seconds from aspiration:

Important
The instrument is ready to
accept the next sample af-
ter the flashing display cur-
1059en.gif sor in the upper left display
corner disappears.
Entering the next sample
7.3 Analyzing the Sample (Pre-Dilute) before the flashing cursor
Any dilution rate between 1:200 and 1:250 can be used under the condition that
disappears will result in er-
the minimum total volume is 5ml and the maximum volume 8 ml. It is obvious
roneus parameter results
that always the same dilution rate must be chosen as any reproducibility error in
for the next sample.
an external dilution will directly affect the counted parameters.

Examples:
• 20 µl and 5 ml diluent, 30 µl and 6 ml diluent or 40 µl and 8 ml diluent
The sample should be analyzed as soon as possible. Prolonged waiting increases
the inaccuracy of the MCV and WBC differential parameters.
• Place the cup with the pre-diluted sample under the aspiration pipette for
pre-diluted samples and press the lever behind the pre-dilute aspiration pi-
pette.
Note that the instrument aspirates more than 5 ml. Volumes over 5ml are not
specified. This means that in most cases the whole sample (volume) is aspirated
into the analyzer.
• Remove the sample cup after aspiration.
The display sequence on the LCD screen is identical to the description in Rou-
tine Operation on page 53 above.
If no sample was entered and the pre-dilute start lever was pressed anyhow, the
system will recognise this and restore the liquid flow system automatically.

1060en.gif

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 Routine Operation

7.4 Analysing the Sample

(Micro Pipette Adapter, MPA)
The Micro Pipette Adapter (MPA) is a device that allows the operator to use di-
rect capillary samples without any pre-dilution. This is suitable in case the patient
is nearby the instrument, like small care-stations or private doctor's offices and
especially when used as a pre-donor screening device at blood banks. Capillary
tubes used are high precision 20 µl (+/- 1%) EDTA tubes supplied by Boule.
1. Press [Menu] so that the instrument is in operational mode. (The previous
sample is displayed).
2. Pull out the MPA adapter, remove the previous sample capillary pipette and
place the adapter on the table in the supplied MPA holder.
The display shows:

Warning
Contamination hazard if
contaminated blood enters
into open cut.
1061en.gif
Always wear protective
gloves when handling
blood samples. 3. Puncture, using the Boule Micro Lancet.

(Gloves in the picture are

not shown for clarity rea-
sons only).

1062.jpg

4. Aspirate the sample as shown below.

Caution
Always insert the capillary
tube in the longest metal
tube of the MPA.
Inserting the capillary tube
in the shortest metal tube
1063.jpg
of the MPA might damage
the MPA or break the cap- 5. Insert the micro pipette (capillary) in the longest tube of the MPA device.
illary.

1064.jpg

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 Routine Operation

6. Insert the MPA into its holder and the instrument will automatically start
the analyzing sequence.

Important
Fill the micro pipette com-
pletely and wipe off the ex-
cessive blood on the
outside surface.
1065.jpg Ignoring this instruction
might cause incorrect and
Note: non-reproducable results.
7. Detailed movie shots are available on Boule’s support server how to use the
MPA system in detail. Please put your browser to the following address and
download the MPEG movie shots. The movie shot shows also how to clean
the Micro Pipette before it is loaded into the MPA.
www.medonic.se/MPA/

7.5 Analysing the Sample

(Cap Piercing Device)
The cap piercing device model 220 is an optional built-in unit that enables the in-
strument to be used with several types of closed tubes. A tube selector is used
with 6 positions giving the operator the ability to use 6 different kinds of tubes.
A motor driven needle is penetrating the closed tube and aspirating the sample
after which the needle and aspiration tube is cleaned and dried.
The closed tube might be of a vacuum or zero pressure type. The adapter handles
even a slight over pressure in the closed tube in a correct way. The minimum vol-
ume in the closed tube should be ca. 1 ml using a standard B&D tube with a Important
length of ca. 73 mm. Maximum length of tube
77 mm. Lengths exceeding
1. Rotate the wheel to a position that fits the dimension of the tubes you are this dimension will not fit
using. The positions can hold auxiliary adapter devices that can be ordered into the adapter.
from Boule to fit your local needs.
Use only tubes with a max-
imum length of 77 mm

Warning
Contamination hazard if
contaminated blood enters
into open cut.

1066.bmp
Always wear protective
gloves when handling
blood samples
(Gloves in these pictures
are not shown for clarity
reasons only.)

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 Routine Operation

2. Push (rotate) the protection cover to the left and insert the tube up-side
down.

Caution
Insert the sample tube
with lid facing downwards.
Ignoring this instruction
may damage the aspiration
needle.

1067.bmp

3. Push (rotate) the protection cover to the right.

Caution
Avoid using the same tube
more than twice in the cap
piercing device.
Not doing so might in-
crease the risk that rubber
particles from the lid clogs
the instrument which leads
to incorrect results and/or
excessive service.

1068.bmp

The aspiration cycle is now started following the sequence as described in Anal-
ysing the Sample (Open Tube) on page 54.
Remove the tube after the sample parameters are displayed in reversed order. The
adapter is ready to accept the next tube when the sample parameters are displayed
and the flashing cursor in the parameter-field of the display disappears.

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 Routine Operation

7.6 Advanced User Options

(CA620-CellGuard)
In section Routine Operation on page 53, the normal use of the instrument is
described.
The system was either used for “Blood mode” or “PLT concentrate mode”.
It is possible however to switch between these 2 modes without altering menu
5.8.
Suppose the following:
In case the CA620-CellGuard was set up for “PLT concentrate mode” as default
but it is required to analyze some whole blood samples.
Proceed as follows.
1. Press the “up/down”-keys until PROG 1 is displayed within the “Opera-
tional mode” Note that the text PROG1 might have been replaced with the
text “Blood”. See Set PROG names on page 71.
The LCD display shows the following.

1069en.gif

2. Aspirate the sample by pressing the start lever or pull out the MPA.
3. After the aspiration of the sample or insertion of the MPA, enter the sample
ID if required.
The sample is now processed as “Blood” and all PROG 1 settings are applied to
this sample.

Note:
The next sample will “fall back” to the default PROG mode unless again changed
by the user.

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 8 User Interface
This section describes the function of each available menu in the instrument that
is not described in any other section of this manual.
The service menu is described in the service manual and is available in English
only to your authorized distributor.
The main menu is used to directly select the most commonly used functions. Di-
rect access to the Sample memory, as well as easy access to the System flow menu,
is provided.

1071en.gif

8.1 Sample Memory

Entering position 1 from the main-menu gives access to the sample memory.
View, print Statistical calculations and delete functions are selected by ID#, SEQ
#, Date or PROG in any combination. In case the memory is full, the oldest sam-
ple is automatically deleted. As default, the current date is used, giving direct ac-
cess to all samples during the current day.

1072en.gif

In the display example above it is seen that a total of 19 samples are in memory
but none (0) during the current date. The whole memory, in this example 19 sam-
ples, is selected by just pressing [Enter] at the “From Date” line in menu 1.4.

1073en.gif

Use the arrow down key to select other condition-selections. The selected num-
ber of samples is always displayed as well as the total number in memory. Press
[Menu] to return to the previous menu 1.4 to 1.8.
Please find below some examples how the sample memory can be used.

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 User Interface

Question 1 (example):
To-days date is 20 July 2003. We have a sample in memory tagged as ID = 1021.
This sample was analyzed 9 times during this day. We want to determine the CV
of this sample.

Answer:
1. Enter the “Sample Memory”.
2. Scroll to “ID =”
3. Type 1021
4. Press [Enter]
Now, the display shows SEL “9 of 75”, confirming that 9 samples with this ID
were found in memory of total 75 samples.
5. Scroll down to “Statistical Calculations”.
6. Press [Enter]
7. Press [Print] if a printout is required.

Note:
Statistical calculations are done on both Normal+Abnormal and Normal param-
eter values only.
“Abnormal parameter values” are defined as being all values except 0 or out of
measuring range.
Normal parameter values are values within the parameter normal range as set in
menu 5.4.
SD, CV, X and n are displayed for each parameter.
Use the “left/right”- keys to scroll between the parameters and use the “up/
down”-keys to select SD, CV, X or n for NORM+ABN or NORM values only.
Pressing [Print] will print all available data to the selected printer. This is the rec-
ommended way of listing the statistical calculations.
Below is an example of a Statistical calculations display with no specific ID selec-
tion:

1074en.gif 1075en.gif

The example above shows that on RBC, 16 samples are present in the selected
memory whereof 9 within the normal range.

Question 2 (example)
We want to have access to all samples in memory and scroll backwards through
all samples.

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 User Interface

Answer:
1. Enter the “Sample Memory” menu 1.
2. Scroll down to line 1.4 and press [Enter].
3. Scroll to line “From Date=” and press [Enter].
Now, the bottom line will change to “198 OF 198”, confirming that all samples
in memory are selected. (the number “198” is an example only).
4. Press [Menu] to return the menu 1
5. Scroll to line 1.5 and press [Enter].
The display shows now the last sample in memory.
1. Use the “up/down” keys to scroll through the sample memory.
2. Use the “right/left” keys to display different parameters.
The [Print] key can be used to print a specific sample.

1076en.gif

The letter 'M' is displayed in the upper right corner to indicate that the display
shows a sample in memory and not the last run.

Question 3 (example) CA620-CellGuard

We want to check the mean value of all PLT concentrate samples in memory.

Answer:
Enter the “Sample Memory” from the main menu 1.
1. Scroll down to line 1.4 and press [Enter].
2. Scroll to the line “From Date=” and press [Enter].
3. Scroll down with the “up/down” key to the line PROG and select “2”. As
“2” is assigned to PLT concentrate mode.
The display might change to “22 OF 200” confirming that 22 samples were tested
in PLT concentrate mode.
4. Press [Menu]to return to the sample memory menus.
5. Scroll down to Q/C calculations and press [Enter].
6. Press [Print] to get a print out of the statistics.

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 User Interface

8.2 Setup Menu

Within the setup menus all user settings are defined, calibration, normal range
settings etc.
Scroll to line 5 in the main menu and press [Enter].
Scroll with the “up/down” keys to display the second page of the set-up menu.

1077en.gif 1078en.gif

Set parameter normal ranges

In this menu the normal range for each parameter can be defined. Parameter val-
ues outside these limits are marked with '*' on the LCD display and H (high) or
L (low) on the printout. Normal ranges for each parameter might vary consider-
ably between populations and should be established using local population mean
values. The default values are set according to medium values within the EU and
US and can be listed on the connected printer by choosing menu 5.9.
The instrument has the possibility to set 9 different normal range settings as-
signed to PROG1-9. Within the CA620/530, PROG 1 is assigned to 'human
blood mode' and PROG 8 is assigned to blood controls. PROG 3 to 9 (except 8)
are not assigned to any particular application but could be used to set “Normal
ranges”, for example male/ female or children.
Scroll with the arrow keys to menu 5.4 and press ‘Enter’.
The following is displayed.

1081en.gif 1082en.gif

Enter the required ranges by using the numerical key pad.

1. Validate with [Enter].
2. Scroll through this menu using the arrow keys.
3. Press [Menu] to return.

Note:
Each PROG has its own set of “Normal Range settings”, “Floating PLT/RBC
discriminator settings” and “WBC differential settings”. The Calibration is the
same for all PROGs

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 User Interface

CA620-CellGuard
1. Enter PROG 1 to set normal ranges for “Blood mode” as shown above.
or
2. Enter PROG 2 to set normal ranges for “PLT concentrate mode”.
The following example sets the normal range limits for “PLT concentrate mode”.

1083en.gif 1084en.gif

Note
that several parameters do not have normal ranges set as they are blocked from
being displayed and printed. See also menu 5.10.12 'Block parameters'.
Enter the required ranges by using the numerical key pad.
3. Validate with [Enter].
4. Scroll through this menu using the arrow keys.
5. Press [Menu] to return.

Set floating discr. PLT/RBC

Scroll with the arrow keys to menu 5.6 and press [Enter].
In this menu the floating range for the discriminator (also called threshold) is set
for each PROG. It is not advisable to alter the PROGs default settings. The de-
fault is set to values that are strongly recommended.

Blood mode
In the example below, PROG 1 is shown by pressing [Enter] and the settings for
the floating discriminator are displayed.

1085en.gif 1086en.gif

The displayed fields are:

a) PLT-L. The lowest possible setting for the floating threshold between PLT
and RBC in fl (= µm3). As default this is set to 15 fl.
b) PLT-H. The highest possible setting for the floating threshold between PLT
and RBC in fl (=µm3). As default this value is set to 30 fl, which is the max-
imum level available in this menu.

Note:
Applicable for CA620-CellGuard

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 User Interface

c) PLT conc. mode is set to “0” as PROG 1 is assigned to “Blood mode” only.

PLT concentrate mode

The example below shows the default values set for PROG 2, which is assigned
to “PLT concentrate mode”.

Important
Do not alter PLT conc.
mode. This must be “1” to
enable the correct sample
aspiration mode.
1083en.gif 1088en.gif
Setting PLT conc. mode to
“0” will aspirate the sam-
The displayed fields are:
ple for 10 seconds and
a) PLT-L. The lowest possible setting for the floating threshold between PLT macro Platelets up to 60fl
and RBC in fl (=µm3). As default this is set to 15 fl will not be counted.
b) PLT-H. The highest possible setting for the floating threshold between PLT
and RBC in fl (=µm3). As default this value is set to 60 fl, which is the max-
imum level available in this menu.
c) PLT conc. Mode is set to “1” as PROG 2 is assigned to “PLT concentrate
mode” only. Setting this menu to “1” enables the PLT-H setting to a maxi-
mum level of 60 fl. This setting (60fl) is chosen as default in PLT concen-
trate mode to include possible macro PLTs in the total PLT count.
This setting “1” also enables the aspiration mode to switch to a time aspiration
instead of using the Blood detector.
Also, if PLT-H is set to 30 fl instead of 60 fl, all PLTs larger than 30 fl will be
reported by the system as RBCs, which might introduce a slightly false RBC pa-
rameter value. Therefore, it is recommended not to change this setting without a
compelling reason.

Set discr. WBC

Scroll with the arrow keys to menu 5.6 and press [Enter].
In this menu the total range is set in fl, for which the mathematics are applied to
check for a valid LYMF and GRAN population within the 3 part differential.
The settings in all PROGs are the same and set as default to 40-330 fl. Hence, the
software will look for a valid population where 2 main modes (peaks in the his-
togram) is found within this volume range.
It is not recommended to alter these settings without written instructions from
Boule.
The following is displayed.

1089en.gif 1090en.gif

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 User Interface

The displayed fields are:

a) LYM-L. The lowest possible mode (peak on the histogram) where Lym-
phocytes might be detected.
b) GRAN-H. The highest possible mode (peak on the histogram) where Gran-
ulocytes might be detected.
In case any of the modes (peaks on the histogram) are outside these limits, the 3-
part differential is aborted and a NM or OM differential flag is displayed.
See further Parameter Flags on page 33.
Set default discr. program CA620/530
This menu sets the default mode of the instrument, which PROG setting is used
whenever a sample is aspirated.
Setting menu 5.8 to “1” will select all PROG 1 settings, which equals
“Blood mode” as default with any aspiration of a sample.
Setting menu 5.8 to “2” will select all PROG 2 settings, as default with any aspi-
ration of a sample.

1091en.gif

Print all settings

1. Scroll with the “up-down” arrow key to menu 5.9.
2. press [Enter].
The connected printer will list all settings that are user programmable. It is advis-
able to do so after the installation procedure is finished to backup and save the
original settings of the instrument. Detailed information of each printed value is
listed in the CA620/CA530 Service Manual. The printed list is listed in the En-
glish language only to simplify service, maintenance and failure reporting to the
manufacturer.

1092en.gif

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 User Interface

8.3 Setup Menu 2

1. Scroll with the up-down arrow key to “Setup menu 2” (menu 5.10).
2. press [Enter].
The following is displayed.

1093en.gif

Within setup menu 2, less common functions are displayed and altered, such as
language, units etc.
To set language and units; please refer to Initial System Configuration on page
47.

Machine ID
Refer to Setup Menu 2 on page 68 above and scroll down with the arrow keys
to the line “Machine ID”.
This menu is only of use in case the instrument is connected to a computer sys-
tem. On the serial output a Machine ID number is sent to the connected com-
puter to identify the instrument in case that several Boule analyzers are used in a
lab. In such an environment the Machine ID can be set to the serial number of
the instrument to give the host a positive identification from which system data
was sent.

Blood detector setup.

Refer to Setup Menu 2 on page 68 above and scroll down with the “up/down”
arrow keys to the line “Blood det. Norm”, see below.

1094en.gif 1095en.gif

The CA620/530 aspiration of samples in “Open tubes” and “Cap piercing” is

stopped when the sample (blood) reaches a blood detector, which is located after
the shear valve system. This blood detector consists of a (green) LED and a pho-
tocell. Within 10 seconds after the aspiration command, this device should detect
blood. In case no blood is detected, the system will proceed anyhow.
Setting this menu 5.10.4.1 to “0” will enable the blood detector function of the
CA620/530. This means that if the instrument is used in “Blood mode”, the set-
ting must be “0” at this line.

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 User Interface

Applicable for CA620 CellGuard

Scroll down with the arrow key to menu line 5.10.4.2.
In this menu line “Blood det. PLT-C” the aspiration time is set in seconds. As the
Blood detector cannot detect PLT concentrate, this function is disabled and the
aspiration of the sample is based on a time set in this menu. To check that this
time is correct, observe the flow of the PLT-concentrate during the sample aspi-
ration. The aspiration should stop when the PLT concentrate has passed the
blood detector with at least 3 cm. If not, adjust the setting accordingly.
An aspiration time of 1.5 seconds is set as default as seen above.
Hence; the text “0=ON” means that the blood detector is enabled. If set to a val-
ue > 0, the aspiration timer is enabled and the display shows the aspiration time
in seconds.

Serial port setup

In case the instrument is connected to an external computer, the serial data flow
has to be set. Scroll to this menu line with the arrow keys and press [Enter].
The following is displayed.

1096en.gif

Change the setting, if required, by using the “left/right” arrow keys and jump to
another line within this menu with the “up/down” arrow keys.
See further in section Printer and Serial Output on page 93.

Barcode reader
In case a Barcode reader is connected (available from Boule as optional device),
the device must be enabled in this menu.

1097en.gif

Scroll with the “up/down” arrow keys to line 5.10.6.

If no Barcode reader is connected, this line must read “0”. The available Barcode
reader from Boule is enabled by setting this line to “2”.
In case the ISBT code is used as standard in blood banks, select “4” instead. This
will cancel all leading “=” and “&” signs.

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 User Interface

PLT offs and High altitude comp

In menu 5.10.7 the PLT background can be set. This entered value is subtracted
from all PLT readings. This menu should be handled with care and only used if
the diluent background on PLT is stable and not higher than 10.
The menu 5.10.8 is used whenever the instrument is installed at levels higher than
1500 meter (4500 feet) above MSL (Medium Sea Level).

1098en.gif

Scroll down to this line using the arrow keys and set '1' in case the instrument is
located above 1500 meters (4500 feet) MSL.
This setting will only extend some of the washing sequences in the instrument
due to the capacity reduction of the waste (drain) pump when used at high alti-
tudes.
No other instrument specifications will be affected.

Print control blood id:s

1000en.gif

This menu prints out a list of defined quality control-blood types. Type [Enter] at
this menu line to print out the list. As quality control-blood is not comparable
with human blood regarding the structure of the WBC differential mainly, certain
discrepancies in the total WBC count and/or differential count might occur
whenever using such fixed cells as a normal sample. Entering the defined ID
numbers as obtained from the list, terminated with a “+” sign (right arrow key),
will instruct the instrument to shift it's discriminator range automatically so that
it fits the specific control-blood see also section Calibration and controls on
page 81, in this manual.
Example of a printout:

777+ Boule Low

888+ Boule Norm
999+ Boule High

Thus; entering one of the above defined control-blood Product-numbers as ID#,

will be shown on the display (only) in clear text as a confirmation that the control-
blood mode was selected. E.g.: 888+ will display “Boule Norm.”, but is stored in
memory as 888+.

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 User Interface

Hence, enter such control blood by typing 888 and press the “right” arrow key.

Note:
Entering a specific control blood Using 777+ to 999+ Boule control bloods, are
stored as default in PROG 8.

Reagent type
This menu line is only used to initialise the basic set up at the factory. It defines
for which purpose the instrument is used and stores the correct default values.
This menu is password protected and cannot be altered by the user. It should
show “15” for the CA620-CellGuard and “11” for the CA620/530, in all cases.
CA620-CellGuard CA620/530

1100en.gif 1014en.gif

Set PROG names

As described in previous sections, the instrument is equipped with 9 preset- table
programs which are linked to “Floating discr. RBC/PLT”, “Set parameter normal
range” and “WBC discr. Program”.
Assigning the PROG numbers to a name, that is shown on the display as well the
printout at each sample, will simplify the identification of in which mode the sam-
ple was run.

Example on how to assign a name to a PROG #

The CA620-CellGuard has 2 defined programs PROG1 and PROG2.
PROG1 is assigned to “Blood” and PROG 2 is assigned to “PLT concentrate”.
Therefore, it is advisable to set the name for PROG1 to “Blood” and the name
for PROG 2 to “PLT-C”.
To do so,
1. Scroll down with the arrow keys to the line “Set PROG names”.
2. Press [Enter]
The following is displayed:

1101en.gif 1102en.gif

In the above example, we want to set the name “Blood” for PROG1.
Press [Enter] and the sub menu is displayed asking to define the text to be shown
on the display and printer.

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 User Interface

Press [Enter] to set the required text on the display or scroll to the next line to
alter the printed name on the printout instead.
The following is displayed.

1103en.gif

1. Scroll with the “up/down” arrow keys through the displayed field.
2. Press any digit to select the required character.
3. Press [Enter] to return.
Changing both PROG1 and PROG2; the list will now show:
CA620-CellGuard CA620/530

1104en.gif 1146en.gif

Note
That the PROG names are not changed in any menu to “Blood” or ”PLT-C” but
clarified only as shown above.
The display and printout however will show “Blood” or “PLT-C” instead of
PROG1 or PROG2.

Block parameters
The CA620 allows the operator to block certain parameters to be displayed and
printed. This is especially useful when the instrument is used for PLT concentrate
control only. Several parameters are of no interest in such case, like HGB, HCT,
MCHC etc.
To do so:
1. Scroll with the arrow keys to line 5.10.12 “Block parameters”.
2. Press [Enter]

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 User Interface

The following is displayed.

1105en.gif

1. Scroll down to the line PROG 2 in case some of the parameters in the PLT
concentrate mode should be blocked. See below.
2. Press [Enter] and the next sub menu is displayed.

1106en.gif 1107en.gif

In this menu, setting a “1” to a parameter means that it will be displayed and
printed. Setting “0”, will block the parameter from the display and printout.
In the above example it is seen that all parameters are blocked except RBC, PLT,
MPV, WBC and LPCR whenever the CA620-CellGuard is used in PLT concen-
trate mode.

Printer setup menu CA620

This menu is used for advanced printer options and user definable printout pro-
gramming.

1108en.gif

Detailed information is available in appendix 530-30-205. Please contact your lo-

cal distributor in case special printer functions are required. This appendix is
available in the English language only and requires basic knowledge about print-
ing protocol, formats, font setups etc.

Block pre-dilute start

This menu is used to delay the pre-dilute start switch with 5 seconds. Set '1' to
enable this function.
To minimize the risk that a user enters whole blood at the pre-dilute inlet, this
mode might be enabled.

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 User Interface

In such a case, one must keep the pre-dilute start lever pressed for 5 seconds to
start the pre-dilute aspiration.

1109en.gif

Service menus
Service menus, starting at line 6 of the main menu, are used by your authorized
distributor to check and maintain the instrument. These menus are described in
the Service Manuals available to your authorized distributor on CD-ROM. Sev-
eral of these menus are password protected. For clarity reasons and back report-
ing to the manufacturer, service menus and the proper description of each is
available in the English language only.

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 9 Warning Displays
Warnings are displayed in clear text in case of any abnormal situation.This section
shows the available texts if not mentioned in other sections of this manual.
This section lists all available warning texts.

9.1 Warnings Related to the MPA and

Pre-Dilute Inlet

1110en.gif

This is a normal warning and indicates that the MPA was pulled out. The instru-
ment is waiting for the MPA to be inserted where after a count cycle starts auto-
matically.

1111en.gif

The MPA cycle was aborted by pressing the [CE] key. Push back the MPA. The
system will not start a count cycle.

1112en.gif 1113en.gif

The MPA was pulled out before the cycle was finished. Push back the MPA
adapter and the instrument will restore the flow system with a prime cycle. See
menu message above.

1114en.gif

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 Warning Displays

The MPA was pulled out in a wrong mode (a menu was displayed). The MPA may
only be pulled out in “Operational mode” where the last run sample is displayed.
The operational mode is selected by pressing the [Menu/Operate] key.

1115en.gif

The above warning indicates that the Pre dilute Sample inlet was activated but no
sample was aspirated. This might be caused by:
a) No sample is entered.
b) An attempt is made to run on distilled water in the pre-dilute inlet.

9.2 Stand-By Mode

This warning is displayed after a 45 minutes idle situation. The instrument will go
to stand-by mode after a further 2 minutes. The operator may cancel this by
pressing [Menu].

1116en.gif 1117en.gif

If the instrument is in Stand-by mode, the text displayed might not be clear as the
back lighter of the LCD display is switched off. The instrument will now perform
an auto check and cleaning cycle every 4th hour.

1118en.gif 1119en.gif

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 Warning Displays

In case one of the reagent containers are empty within the Stand-by mode, one
of the above warnings will be displayed. It is essential that new reagent containers
are installed, as the 4-hour checking cycle cannot be performed by the instru-
ment.

1120en.gif

This warning indicates that an error indication occurred and it was not cleared by
the user before the system entered the Stand-by mode.
Restart the instrument, cancel indications by pressing [CE] and perform a
“Prime” from menu 8.1

1121en.gif

When the instrument is in Stand-by mode, and the [Menu] key is pressed, the sys-
tem will perform a “Prime cycle” to restore the flow system. This lasts for approx.
2 minutes.

9.3 Reagent Empty

1122en.gif 1123en.gifs

The above warnings are displayed in case of an empty reagent container. Replace
and perform a “Start prime cycle” menu 8.1 from the “System flow menu”,
menu 8.

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 Warning Displays

9.4 Printer and Serial Output

1124en.gif 1125en.gif

The warning messages above are related to the connected printer. Either the
printer is not connected or busy.

1126en.gif 1127en.gif

The above warnings indicate that no printer is connected or no computer is avail-

able on the serial output. The Print-key functions were incorrectly programmed.
E.g. the serial output was selected but no computer was connected.

1127en.gif

The above warning is displayed in case the connected computer serial line is busy
and not ready to accept data.

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 Warning Displays

9.5 Auxiliary Warnings/Messages

1129en.gif 1130en.gif

The above messages are displayed from the sample memory only. Printing of 19
samples is selected. The second warning shows a question in case a deletion of 19
samples is requested from memory.

1131en.gif

The above is displayed during a [Power-On]. The instrument performs a self-

check, which might last for maximum 15 minutes in case the instrument was ex-
posed to extreme temperature or humidity changes. Normal self check time is 2
minutes.
The indicated figures are examples only.

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 Warning Displays

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 10 Calibration and controls
10.1 Introduction
The instrument has been calibrated at the factory. This applies to all measured
parameters. As the instrument has a mechanical fixed metering unit and fixed me-
chanical micro-volumes; the numerical calibration for the RBC/WBC and PLT
are basically stable at all time. Good laboratory practice however, requires regular
checks and calibration of the measured parameters.
The software calibration factors for all measured parameters can be changed by
the user within a large range. This is done to match other analyzers, methods or
applications in the laboratory.
It is advisable that the performance of the CA620/530 system is checked daily
(not calibrated) with a certified control blood. Special attention should be paid to
the calculated MCHC parameter (MCHC = HGB/(MCV*RBC)).
Recommended calibration periods are twice a year with an 'Hematology Blood
Calibrator' certified by Boule.
The MCHC parameter can be used as an excellent check on the relation between
Important HGB and HCT. This parameter should be in the range of 30 - 37 g/dl. Daily
Do not calibrate the MCV
mean values of the samples should always be 32 - 36 g/dl.
parameter using commer-
cial controls with values RBC, WBC and PLT
given for other analyzers, Calibration of the above-mentioned parameters is done at the factory with refer-
unless approved by Boule. ence standard instruments and volumetric measuring methods. The metering
Not following this might tube is mechanically constant and will remain stable.
lead to incorrect MCV val-
MCV
ues on processed samples Calibration of the MCV parameter may be necessary if the temperature environ-
ment of the laboratory has changed significantly. (> ∆10 °C)

10.2 Use of Calibrators and Controls

The calibration of the instrument can be verified by counting pre-assayed com-
mercial reference control samples or by counting retained patient samples with
known reference values from another “reference” instrument.
Important
Use the special ID func- To ensure the accuracy of the values obtained whenever commercial controls are
tion to identify the specific used:
control blood. See Print
1. Always re-suspend according to the manufacturer's recommendations.
control blood id:s on
page 70. 2. Never use an open vial longer than recommended by the manufacturer or
Not doing so might lead to subject any vial to excessive heat or agitation.
incorrect WBC values.
3. Verify the condition of controls when received. Make sure that they are cold
and not leaking.
4. Do not use a commercial control for calibrating the instrument, use only
“Calibrators”.

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 Calibration and controls

In order not to contaminate the calibrator or control with cleaning solution, be

sure to dry the aspiration pipette manually on the outside at each control blood
run. Not following this discipline might give dropping values over time on the
concentration parameters like RBC, HGB, WBC and PLT. See picture below.
Dry the aspiration pipette manually
Warning
Contamination hazard if
contaminated blood enters
into open cut.
Always wear protective
gloves when handling
blood samples

1132.bmp 1133.bmp 1134.bmp

.
Do not push the sample tube against the Correct sample handling
washing device

Important
Dry the aspiration pipette
manually on the outside at
each control blood run
and do not push the con-
trol or calibrator tube
1135.bmp 1136.bmp against the upper washing
device. See pictures.
Not following this disci-
10.3 Calibration on a Known Sample pline might give dropping
The following procedure can be used in case no Hematology Blood Calibrator is values for the RBC, HGB,
available or if the recommended transport conditions of such cannot be met. PLT and WBC parameters.
The RBC, WBC and PLT values can be obtained by using a reference analyzer or
a microscope method.
The hematocrit should be checked with a micro centrifuge method and the he-
moglobin with the cyan meta-hemoglobin method on a reference photometer
system.
Calculate the MCV by: MCV =HCT/RBC.

Procedure:
1. Make at least 3 HCT determinations with a micro centrifuge and calculate
the mean value.
2. Make at least 3 HGB determinations with the cyan meta-hemoglobin meth-
od and calculate the mean value.
3. Perform blank counts on the instrument and check that the background is
according to the limits stated in chapter Analysing the Sample (Open
Tube) on page 54.
4. Aspirate and analyze the known sample at least six times. Print the parame-
ter results of each count.

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 Calibration and controls

5. Check that the CV values1 of the measured parameters are within the fol-
lowing ranges:

WBC < 2.8%

RBC < 1.2%
PLT < 5.5%
MCV < 0.8%
HGB < 1.2%

6. Calculate the difference as per cent between the mean of the results ob-
tained by the instrument and the known values of the sample.
7. Select “Calibration Whole Blood” from the “Setup menu”.
8. Scroll to the parameter that has to be adjusted and enter the percentage that
was calculated. Use the -/+ key (=right arrow key) to select a - or a + cor-
rection.
In the example below, the RBC is adjusted with +2.0%

1137en.gif 1138en.gif

Hence, the direct calibration method is performed by selecting the parameter to

be adjusted with the arrow keys, move the cursor to the field “New” (cursor field
in case of a CA530) and enter the calculated percentage.
9. The last run sample will be recalculated and can be printed on the selected
printer output.

10.4 Calibration Through a Certified

Calibrator
Recommended calibration periods is twice a year with a “Hematology Blood Cal-
ibrator” certified by Boule.
Good laboratory practice involves regular daily checks with blood controls to as-
sure the analyzer and reagents are fully functional. Calibration procedures are car-
ried out to minimize any possible drift caused by tolerances in reagents,
environment- changes or instrument.
Important
Do not calibrate the in- Please note that calibration is only possible on measured parameters e.g.:
strument using commer- RBC, WBC, MCV, HGB and PLT.
cial controls or calibrators Use a Boule certified PLT-Concentrate calibrator to calibrate the CA620-Cell-
with values given for other Guard for PLT concentrates on the PLT-C and MPV-C parameters. The proce-
analyzers. dure is identical as described below.
This might lead to incor-
rect calibration of the in- 1. The CV values are stated higher than the typical CV of the instrument due to
strument. the limited number of sample runs.

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 Calibration and controls

The following calibration procedure is used for the CA620 and the CA620-Cell-
Guard, using a Boule certified whole blood calibrator:
1. Run the calibrator 5 times at the open tube inlet. Follow the guidelines
shown in Use of Calibrators and Controls on page 81 above. Enter the
ID 888+ for each run; entered as 888 and terminated with the right-arrow
key. See Print control blood id:s on page 70. In case the calibrator was read
by a bar-code reader as outlined in Initializing the Levey-Jennings Plots
and Functions on page 87, use the calibrator ID instead of the 888+ entry.
To display a quick overview which controls and calibrators are defined, go
to menu 5.10.9 and press [Enter] to print a list with control/calibrator def-
initions.
2. Go to menu 5.1. The following is displayed:

1139en.gif

The mean value and CV of the last 5 samples are shown.

3. Scroll with the “left/right” key to the parameter that has to be calibrated and
check that the shown CV values1 are less than:

WBC < 4%
RBC < 1.8%
PLT < 6%
MCV < 1%
HGB < 1.8%
MPV < 5% (if applicable)

In case one run should be excluded from the auto calibration to reduce the CV,
move the cursor to the specific sample and press [Enter]. The display of “Use”
will show “0” on such sample, indicating that it is not included in the auto cali-
bration.
It is also possible to print out a sample by moving the cursor to a sample line and
pressing the [Print] button.

1. The CV values are stated higher than the typical CV of the instrument due to
the limited number of sample runs.

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 Calibration and controls

4. Enter the target value read from the assay sheet in the field “Target” and
press [Enter]. The analyzer will calculate the new calibration factor and dis-
play this in the field “New”.

1140en.gif 1141en.gif

In the example above, a RBC target value of 4.40 is entered, resulting in a

new calibration factor of +1.8%. Next time this menu is recalled, the field
“Cal% org.” will show 1.8%.
5. Scroll to the next parameter to be calibrated using the arrow keys and repeat
the above point 4.

Note:
Sample runs with (SE, DE etc.) are not included in the 5 samples displayed in
menu 5.1-5.3. This is shown in the calibration menus as =0 at the sample display.

10.5 Calibration on Pre-Diluted Capillary

Blood
Calibration for the capillary blood inlet is done in the same way as at the whole
blood inlet. Dilute the capillary blood 1:200 e.g. 25 (alternative 20) µl in 5ml dilu-
ent, 30µl into 6ml or 40µl in 8ml. Anything between these values is accepted as
long as the total volume is between 5 and 8 ml with a dilution ratio of 1:200 to
1:250 and is reproducible. Enter the calibration-menu for pre-diluted capillary
blood from menu 5.2 and set the calibration factors.
A practical method is to first calibrate the whole-blood inlet. Secondly, run a nor-
mal sample at the open tube inlet and note down the parameter values, then use
this sample to calibrate the pre-dilute-inlet of the instrument. Note that the pre-
dilute-inlet is not factory calibrated, as the setting is dependent on locally used
capillaries and dilution ratio.

10.6 Calibration of the MPA

The calibration of the Micro Pipette Adapter parameters is similar to the whole
blood and/or pre-diluted blood calibration. The recommended calibration meth-
od is to run a vein blood sample in the (calibrated) whole blood inlet and to com-
pare the results of the same blood at the MPA inlet.
Note that some discrepancies might be observed when comparing to venous
blood and Micro Pipette collected blood from a finger puncture (same patient).
This is a pre-analytical error that might occur especially if the finger puncture is
not done according to the specifications. PLTs might aggregate in case of a bad
blood collection procedure. This may also give erroneous results in the total
WBC and 3 part differential count. Typical differences between vein and finger
puncture collected samples are listed in a report available from your authorized
distributor.
Please point your browser to: www.medonic.se/MPA and down load the movie
sequences how to operate the MPA with the Micro Lancet as supplied by Boule
to minimize such pre-analytical errors.

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 Calibration and controls

10.7 Calibration of RDW, LYMF and GRAN

The calibration of the RDW parameter is performed in a different way due to the
calculation of this parameter. The RDW is calibrated only on the last run sample.
In case no calibrator with known RDW values is available it is recommended to
run 5 normal samples and to calculate the mean of the RDW values. Adjust the
RDW calibration menu 5.1 so that the mean value of these 5 samples is 12.5-14%.
If RDW values for the calibrator are available, set the RDW to the target value.
An example of the CA620 display:

1142en.gif

In the example above, the last sample showed RDW=13.8. The new target value
is entered as 12.5%. The last sample is recalculated to the target value.
Please note that RDW% obtained from blood samples is depending on:
a) How the blood was collected.
b) Temperature conditions in the lab.
c) Mixing conditions of the sample.
d) Type and condition of EDTA in the sample tube.
It is therefore recommended to adjust the RDW calibration within the local en-
vironment.

LYMF and GRAN calibration

In this menu line a correction factor for LYMF/GRAN can be entered. For ex-
ample if we want to increase all GRAN readings with +10%, enter +10 and press
[Enter]. Lymphocytes will be than be adjusted with -10% and Granulocytes to
+10% in respect to the original settings. It is not recommended to use this 'cali-
bration' without instructions from the manufacturer.

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 11 QC and Blood Controls
11.1 Introduction
The CA620 is equipped with a QC memory capable of displaying and printing X-
B and Levey-Jennings plots. The X_B algorithm is defined as the Bull's weighted
moving average model. Long term drift in the sample parameters MCV, MCH
and MCHC are monitored.
Levey-Jennings Plots are used to monitor the short term stability of the instru-
ment using blood controls. To use the L-J function, Boule's blood controls must
be used and the bar-code reader must be installed to define the parameter ranges
and to identify the control.

1157en.gif 1158en.gif

Important Note:
Do not forget to dry the Refer to section “Calibration” how to handle the blood control and how to dry
aspiration pipette manually the aspiration pipette manually in order not to contaminate the blood controls.
on the outside at each con- See Use of Calibrators and Controls on page 81.
trol blood run and do not CA620 and CA530 without bar-code reader.
push the control sample
tube against the upper Blood controls must be identified with the ID number 777+ (low), 888+(norm)
washing device. and 999+ (high). The “+” sign is entered by pressing the right arrow key.
Not following this disci- PROG8 (CNTRL8) is used for the definition of discriminator settings and “nor-
pline might give dropping mal range” settings. Note that the Levey-Jennings plots are not available in case
values for the RBC, HGB, the bar-code reader is not installed.
PLT and WBC parameters.
11.2 Initializing the Levey-Jennings Plots
and Functions
To initialize the L-J functions for the blood control(s), the bar-code reader must
be installed.
Enter menu 7.4 and 7.4.1.
Follow the instructions on the control assay sheet how to read the blood control
data.

1159en.gif 1160en.gif

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 QC and Blood Controls

After the blood control data is read from the assay sheet. Go to menu 7.4.2 to
view the blood control assay values. See example below. Use the left or right ar-
row keys to switch between the 2 displays, see picture below.
12 different blood controls from Boule can be defined and stored simultaneously.
Use the up/down arrow keys to display another defined control blood.
.

1161en.gif 1162en.gif

Press [Enter] at menu 7.4.3 to print out all blood control definitions or press
[Enter] at menu 5.9 to obtain a short list.

Note:
In case all 12 control blood definitions/pages are in use, the next control that is
read via the bar-code scanner will ask the operator to delete the oldest control
samples first before continuing. Also, proper warnings are displayed in case a
wrong bar-code is read or if a bar-code is read out of sequence.

11.3 Use of Blood Controls and

Levey-Jennings Plots
Note:
Refer to section Use of Calibrators and Controls on page 81 how to handle the Important
blood control and how to dry the aspiration pipette manually in order not to con- Do not forget to dry the
taminate the control. aspiration pipette manually
on the outside at each con-
Enter the control by reading the ID with the bar-code scanner from the sample
trol blood run and do not
tube or enter the blood control ID manually and terminate with the “+” sign en-
push the control sample
tered with the right arrow key. Aspirate the control sample and wait for the re-
tube against the upper
sults.
washing device.
The CA620 will identify this ID and match the results with the previous defined
Not following this disci-
control data, see Initializing the Levey-Jennings Plots and Functions on
pline might give dropping
page 87 above. In case a parameter is outside the defined range, a “*” sign is dis-
values for the RBC, HGB,
played in front of the parameter value. Press [Print] to print out the results. The
PLT and WBC parameters.
printout will show either “L” or “H”' indicating that the parameter result is lower
or higher than the assay data.
To display the L-J plots, go to menu 7.2 and enter the requested control in the ID
field with the bar-code scanner or type the number manually and terminate the
control ID with the “+” sign entered with the right arrow key. A third and most
comfortable option is to select the control by using the left/right arrow keys.
The display will show the number of control samples selected in line 7.2.1.

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 QC and Blood Controls

To refine the search and selection criteria of the control, enter menu 7.2.1. See
example below.

1163en.gif 1164en.gif

After the select conditions are defined, enter menu 7.2.2 to display an overview
of the blood control. Use the left or right arrow keys to display the L-J plots. See
example below. The L-J plots are displayed for all parameters defined in the con-
trol assay sheet except the WBC differential parameter “MID”.

1165en.gif 1166en.gif

To print out the L-J plots, go to menu 7.2.3 and press [Enter]. The number of
points printed will be depending on the type and resolution of the installed print-
er.
The figures printed on the vertical scale points to the first plotted horizontal line.
E.g. in the HGB plot in the figure above, the mean value is 12.7. The first hori-
zontal line above the mean value is 13.1 (the max limit for this control) and the
second horizontal line above the mean value is 13.5.
The number of control runs displayed or printed is always counted from today's
date back in time. In the example above, the last run 167 control runs are dis-
played.

Note:
In case a control shows an error or warning flag SE, DE, FD, OF, LO, HI, NG,
TU, TL or TB; the parameter values of such control run will not be included in
the L-J plots.

11.4 Initialization and Use of X-B Function

The X-B function in the CA620 follows strictly the Bull algorithm for the param-
eters MCV, MCH and MCHC.
The above parameters should not drift as a function of time within a large patient
population. The recommended range setting is +/- 3% from the expected mean
value of these parameters.

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 QC and Blood Controls

Enter menu 7.4.4 to alter the expected mean values for the MCV, MCH and
MCHC. It is recommended that at least the MCV and MCH parameters are set
to the expected patient mean values with a range of +/- 3%.

1167en.gif 1168en.gif

To display the X-B Plots, enter menu 7.3 see example below.

1169en.gif 1170en.gif

By default, all sample data is selected. Refine the display criteria if requested by
entering a date window in menu 7.3.
Go to menu 7.3.1 to display the X-B data summary and use the left or right arrow
key to display the plots.

1171en.gif 1172en.gif

The data points displayed are always from today's date back in time. In other
words, the last data points are displayed. In the example above, 200 points are dis-
played giving the mean of 4000 samples as each point is the mean value of 20
samples.
The figures printed on the vertical scale points to the first plotted horizontal line.
E.g. in the MCHC plot in the figure above, the mean value is 34.0. The first hor-
izontal line above the mean value is 35.0 (the max limit set in menu 7.4.4) and the
second horizontal line above the mean value is 36.0.
Go to menu 7.3.2 and press [Enter] to printout the X-B Plots. The number of
points printed will be depending on the type and resolution of the installed print-
er.

Note:
Samples with an error or warning flag SE, DE, OF, LO, HI, NG, TU, TL or TB
are not included in the X-B Plots.

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 QC and Blood Controls

11.5 Display of Blood Control Data

To display blood control data, enter menu 7.1 which is analogue to (main) menu
1 but exclusively for control blood. Use the left/right arrow key to display a de-
fined control or type in the control ID manually and use the “+” sign as the ter-
minator. The “+” sign is entered with the right arrow key.
Line 7.1.4 will show the number of control samples selected.
Enter menu 7.1.4 to refine the search with a date or SEQ (Sequential number)
window
See example below.

1173en.gif 1174en.gif

Enter menu 7.1.5 to view the controls and use the up/down arrow keys to scroll
through the control memory. Size distributions are not saved and displayed for
blood controls.
Go to menu 7.1.6 to display the mean, SD and CV of the selected data and use
menu 7.1.7 to print out the selected controls.
Menu 7.1.8 is used to delete the selected control samples from memory.

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 12 Printer and Serial Output
Following is a description of the printer and data outputs of the CA620/530 and
the CA620-CellGuard analyzers. The system has 2 outputs. One is of a Centron-
ics format and the second a serial output with RS232 specifications. A standard
Centronics cable should be used and connected to a proper printer.
The SEIKO DPU 411-typeII /DPU 414, IBM pro-printer compatible, Epson or
HP - PCL printer is supported.

Note:
A printer or serial connection must conform to EN 60950

12.1 Selecting the Correct Printer Type

Press [Menu] until the main menu is displayed and scroll with the arrow keys to
line 4.

Important
If an IBM, Epson or HP
compatible printer is used, 1150en.gif
it is of great importance
for the correct printing
Press [Print] to printout a list of available formats.
that the actual printer is
supporting the selected Note:
data format. Incorrect Extended printer format settings and user definable print layouts are available.
printing might follow if an Please refer to appendix 530-30-205 for detailed information how to set up a user
improper format or printer definable format. This appendix is available from your authorized distributor in
is selected. the English language only and requires basic understanding of printer protocol,
formats and font definitions.

12.2 The Serial Output/Hardware Connections

The instrument has an output for connection to a computer (network). The serial
output has a male 9 pin DSUB. It fulfils the RS232 specifications.
The pinning of the male 9-PIN-DSUB is as follows:
1. N. C.
2. TX-OUTPUT
3. RX-INPUT
4. N.C.
5. GND
6. N.C.
7. CTS-INPUT
8. RTS-OUTPUT
9. N.C.

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 Printer and Serial Output

Use a correct cable that is specified for RS232 data transmission and don't use
unnecessary high-speed set-ups on the output. This to avoid checksum errors and
to secure a correct data transfer. Enter the menu 5.10.5 and select the proper data
transmission speed and hand shaking protocol.

Note:
To enable the serial output of the instrument, the Print functions in point 2 and/
or 3 of the main-menu must be set properly see Printer Configuration on page
49.

Connections:
PC Computer using a 25 pin RS232
Cable end instrument Cable end PC
9 Pin Female DSUB 25 Pin Female DSUB
2------------------------------------------------------------------- 3
3------------------------------------------------------------------- 2
5------------------------------------------------------------------- 7
7------------------------------------------------------------------- 4
8------------------------------------------------------------------- 5

PC Computer using a 9 pin RS232

Cable end instrument Cable end PC
9 Pin Female DSUB 9Pin 9 DSUB
2------------------------------------------------------------------- 2
3------------------------------------------------------------------- 3
5------------------------------------------------------------------- 5
7------------------------------------------------------------------- 7
8------------------------------------------------------------------- 8

12.3 The Serial Output Format

The data format is of such an extent that the connected computer system also can
trace abnormalities in samples or instrument.
On the user-support site, with the http address stated below, an example is given
of a typical sample including some error marks. Note that the parameter trans-
mission is independent on language settings. The data transmission is always in
English.
Preferably, use a computer in terminal mode connected to the instrument to vi-
sualize the data and to get familiar with the format.
Please put your browser at:
http://www.medonic.se/user-support/CA620-530/dataformat.
And download the available information, such as:
1. Data format description
2. Programming notes

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 13 Maintenance, Shut-Down & Transport
13.1 Daily Maintenance
The instrument has most of its cleaning procedures automated. This means that
the user maintenance is kept to an absolute minimum.
Daily user maintenance is therefore limited to a cleaning procedure only on the
Warning outside of the instrument.
Contamination hazard if
contaminated blood enters 1. Clean the outside of the aspiration pipette with a pure alcohol solution. This
into open cut. removes possible traces of proteins, bacteria or viruses and increases the ef-
fectiveness of the pipette auto-cleaning procedure.
Always wear protective
gloves when handling 2. Remove possible traces of salt crystals or blood with a disinfecting solution.
blood samples or parts of
the instrument that might 13.2 Monthly Maintenance
be contaminated with The monthly cleaning procedure has the purpose of securing the correct func-
blood. tioning of the instrument.
1. Switch off the instrument by pulling out the mains cord from the mains sup-
ply.
2. Open the front 'door' of the analyzer and inspect the instrument for any
trace of salt crystals around aspiration pipette or other directly visible parts.
3. Remove any salt crystal with ONLY distilled water and dry carefully after-
wards.
4. Clean the outside cover with a soft detergent.
5. Close the front door and switch on the instrument.
6. Fill a cup with 10 ml 3-5% hypochlorite (bleach), certified by Boule, and en-
ter this as a sample at the pre dilute inlet.

Caution 7. Run 2 blank samples of 10ml diluent at the pre-dilute inlet.

Do not disconnect the in-
strument from the mains- Report any unusual salt crystal built-up to your authorized dealer.
supply as the analyzer per-
forms automatic self- 13.3 Three (3) Month Maintenance
check cycles every 4th To increase the life time of the tubes in the instrument, the following cleaning
hour to prevent clogging
and bacterial growth in the procedure is strongly recommended.
system. Please call your au- 1. Put both reagent probes in a bottle with “Enzymatic Cleaner”, authorized
thorised distributor in case
the instrument has to be by Boule.
powered off during a peri- 2. Execute Menu 8. 2 (Fill system).
od longer than 4 days.
Not doing so might lead to 3. Wait ca. 30 minutes.
bacterial growth or block-
ages in the system. 4. Remove the reagent probes from the “Enzymatic cleaner” and start menu
8.3 (Empty system).
5. Put both probes back in the original reagents and perform menu 8.2 (Fill
system).

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 Maintenance, Shut-Down & Transport

13.4 Short Term Transport

The instrument can be transported over short distances without performing any
special procedure. Just follow the daily cleaning procedure before the instrument
is transported. Take care that the instrument is lifted at the base chassis. Do not
stress the “front-door”. see Mechanical Check and Set-Up on page 41. Pack
the instrument in its original package and put it in an upright position during the
transport.
Make sure that the instrument is never exposed to excessive heat or cold during Caution
transport. It is important that the ambient temperature is never below 5°C (41°F). The transport according to
Temperatures below the freezing point (of water) can easily destroy essential parts this procedure should only
of the instrument. be carried out if the instru-
Humidity over 95% can also cause serious damage to the instrument when it is ment is going to be rein-
switched on directly after transport. If condensation has occurred, the instrument stalled within 12 hours.
should be warmed up at normal ambient temperature for at least 3 hours before Not following these guide-
it is switched on again. lines might lead to block-
The above transport procedure may only be carried out if the instrument is going ages in the system and/or
to be installed within 12 hours. incorrect functioning dur-
ing the re-installation.
If the above conditions cannot be met, follow the instructions below to transport
the instrument under secure conditions.

13.5 Re-packaging and Long Term Transport

Whenever the instrument has to be transported over a longer distance or if the
system has to be switched off over a period longer than one week, it is necessary
to follow the instructions below.
1. Remove the reagent aspiration tubes from their external container/bottle
and put them in a bottle with clean distilled water.
2. Press [Menu] so that the main menu is displayed and select menu 8.2.
The system is now filled with distilled water, this procedure lasts for approx. 7
minutes.
3. Remove the distilled water bottle.
4. Press “Empty system” from the “System flow menu”.
The instrument is now emptied from distilled water. Some traces of water will be
left however. This is common and correct.
5. Repeat 1 to 4 above.
6. Disconnect the mains supply cable.
7. Insert the valve transport guides that were removed during the installation,
see Mechanical Check and Set-Up on page 41.
8. Pack the instrument using the original wooden shipping containers.
9. Mark the containers with DELICATE INSTRUMENT, FRAGILE and
THIS SIDE UP.

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 Maintenance, Shut-Down & Transport

13.6 Permanent Shut-Down and Storing the

Instrument
To store the instrument follow the packing instructions See Re-packaging and
Long Term Transport on page 96. and the following conditions must be met:
a) Temperature between 5 and 30 °C (41-86°F).
b) Humidity should be less than 80%.

13.7 Disposal information

Warning
Manufacturers recommendation
Contamination hazard. ‰ Place the instrument close to a waste container suitable for disposal of used
Always wear protective reagents.
gloves and/or goggles
‰ Check that the drainage is suitable for disposal of chemical and biological
when handling infectous
waste.
or potentially infectous
materials. ‰ Check that the waste tubing is securely fastened in the drain.

Note:
Customers are advised to be knowledgeable of applicable local, state and federal
requirements, and the contents of effluent streams, before disposing of waste in
public sewer systems.

The disposal material are:

• used reagents
• reagents mixed with infectious specimen
• instrument
• components of the instrument
• controls and calibration material

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 Maintenance, Shut-Down & Transport

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 14 Trouble Shooting
This chapter gives hints to simplify trouble shooting of the instrument and to
minimise external service actions. Also the user might trace a problem to a user-
recoverable error or a case where an external service action might be necessary.

14.1 Counting Time HI (TU & TL)

A counting time displayed as “HI” means usually a clogging in the orifice of the
analyzer. The counted parameter will have a TU or TL displayed as well.
Re-analyze the sample, as the instrument will rinse the orifice automatically.
If a counting time “HI” is displayed frequently, scroll to menu 6.8 and press
[Enter] This program will clean the orifice several times.
If the above doesn't help, proceed as follows:
1. Put both aspiration tubes in a container with an enzymatic cleaner approved
by Boule.
2. Select menu 8.2. Wait 10-60 minutes and refill the system with diluent and
lyzer the same way.

Note:
In case frequently a TU or TL warning is displayed on the WBC parameters, this
might indicate that the pre-dilute inlet is clogged.
1. Attach a syringe with hypochlorite, approved by Boule, to the pre-dilute as-
piration inlet and rinse from any possible clogs.
2. Afterwards, enter menu 8.1 (Prime) to restore the flow system.

Note:
In case the MPA is installed, such blockage might be caused by broken capillary
tubes within the MPA and/or connecting tubes. Call your service dept. in such
case, see also Analysing the Sample (Micro Pipette Adapter, MPA) on page
57.

14.2 Counting Time LO

A counting time displayed as “LO” means that there is air in the metering unit of
the analyzer.
Select menu 8.1 (Prime). The metering units are emptied and refilled with clean
diluent.

14.3 HGB Value Flagged with LO

The “LO” indication means that the blank reference during the HGB measure-
ment was too low. This might indicate a bad lamp or a contaminated cuvette.
Follow the instructions as shown in Three (3) Month Maintenance on page 95
how to clean the system.
In menu 6.2 help functions are available to analyze the HGB system.
The lamp voltage and the output of the photometer will be displayed in this
menu.

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 Trouble Shooting

The lamp voltage is usually ca. 4.5 Volts and the photometer output ca. 3.5 volts.
These values are not critical as long as the photometer output voltage is between
3.2 and 3.8 volts.
If the photometer output voltage is lower than 2.5 volt, a “LO” indication will
follow on the HGB parameter value.
An automatic adjustment will be performed when digit [1] is pressed on the key-
board.
The system will measure the offset, blank and automatically adjust the lamp volt-
age to obtain a correct reference. This procedure takes ca. 5 minutes.

14.4 HGB Value Flagged with HI

The 'HI' indication means that the blank reference voltage in the HGB system is
out of range. (The reference voltage is > 3.8 Volts).
See HGB Value Flagged with LO on page 99 how to correct this warning.

14.5 HGB Value Flagged with OF

This flag is caused by a wrong offset voltage in the HGB system.
During an exit from the stand-by mode the HGB offset is measured. If the offset
value exceeds 1.0 Volt or if this voltage is < 0.02 Volt, this error mark will be dis-
played.
Cause might be:
1. Heavy stray light in the photometer system.
2. Electronic failure.
3. Mains supply disturbance.
The most common failure is that condensation has occurred in the instrument
due to transport or heavy variations in the laboratory temperature combined with
a high humidity environment. Let the system warm up for at least 1 hour in
Stand-by mode.

14.6 High Background PLT

High PLT backgrounds are usually found at installation only. Due to transport
and having the instrument exposed to the outside air; it is occasionally necessary
to make excessive 'blanks' to get the PLT background below 10. Please note that
the longer the instrument is in use, the lower the PLT background.
If the instrument has been used for a long period of time, a high PLT background
might be caused by bacterial growth in the Diluent container. Diluent containers
should be stored at temperatures as indicated on the Diluent container label(s)
A recommended check to trace the background problem:
1. Replace the diluent container with an unopened fresh vial.
2. Perform a “Fill system” from menu 8.2 at least 2 times.
Select the “Noise Test” from menu 6.6 to check if any external disturbance is
present. All displayed figures (AMPL and FREQ) must be zero. If these values
are zero, there is NO line disturbance of any significance and high PLT blank
counts are most probably caused by the Diluent.

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 Trouble Shooting

3. In case the above does not help to reduce the PLT background to accept-
able limits, contact your authorized distributor and request bulletin 000-80-
020 where instructions are given how to decontaminate the instrument.

14.7 Indication Number XXX Displayed

In case an indication number is displayed, the sample memory can still be read.
Any printout can be performed as well.
Note: An indication number is cancelled by pressing the [CE] key.
Detailed instructions regarding Indication numbers are given in the service man-
ual at your authorized distributor.
Note: The instrument will stop immediately.
Further sample processing is disabled until the instrument is disconnected and re-
connected to the mains outlet and the error is cancelled as described below.
Indication numbers in the instrument can be caused by:
1. A mains power failure during any instrument cycle (count, prime etc.).
2. Turning valve motor failure.
3. Syringe motor failure.
4. Waste pump capacity too low.
5. Blockage due to large particles in the mixing cup device.
The following will give the user a first-aid in case an Indication number is dis-
played:

Indication = 1
Date and Time not set. Set within the SETUP Menu.

Indication = 2
The Cap Piercing Device was started and immediately aborted by turning the
safety cover Counter-Clock-Wise.
Press [CE] and the instrument will be operational.

Indication = 9
Auto HGB adjustment failed. The cause might be a broken lamp. Contact service
department.

Indication = 100-199
One of the internal motors or motor drivers failed. Restart the instrument, cancel
any indication with [CE]. If error remains, contact service department. In case of
a wrong installation (no CVT in use) this indication might occur due to excessive
variation of the mains supply. See Mains Supply Environment on page 39.

Indication = 200-299
The diluent status in the internal mixing cup was incorrect. Restart the instru-
ment, cancel any indication with [CE] and do a “Prime” from menu 8.1
These errors might be displayed in case there was an Indication 300-399 previ-
ously.

Indication = 300 - 399

There was a power failure in a cycle, or a cycle was aborted due to a previous in-
dication.

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 Trouble Shooting

Restart the instrument by disconnecting the power and switch on again. Cancel
the indication with [CE] and do a “Prime” from menu 8.1.

Indication = 900-999
Memory failure. Call the service department.

Indication =
-1099 and 2000-2999
Hardware or software failure. Contact the service department.

14.8 Cell Diff. Only on a Few Samples

To be sure that most of the samples are differentiated into a 3-part WBC differ-
ential, the following conditions must be met:
1. Use fresh EDTA blood between 30 min. to 4 hours from sampling.
2. If using pre-diluted samples, they should be analyzed within 5 minutes.
3. The correct reagents should be used, authorized by Boule.
4. The WBC diff. discriminator settings should be correct as advised in section
Set discr. WBC on page 66

14.9 Cap Piercing Device

In case of a needle clogging which occurs occasionally and is dependent on the
quality of the used tubes and processed samples, the needle needs to be cleaned.
Clogs consist of aggregated cells and/or rubber particles from the rubber stopper
of the used tube. Avoid penetrating the same closed tube more than twice as rub-
ber particles from the sample tube cover might contaminate the needle.

Cleaning / Replacing the needle

If blood never arrives at the blood detector during the sample aspiration, a time-
out situation occurs and the instrument warns the operator with a beep signal (10
seconds from the start of aspiration). The results displayed will be zero or far too
low on the counted RBC/WBC/HGB and PLT parameters.
This may indicate a blockage in the aspiration needle of the Cap Piercing device
or a clog in the tubing connected to the needle.
Run one blank sample from the Cap Piercing device and connect a syringe as
shown in the movie shots at the following address.
www.medonic.se/cleaning
Select movie shot 2 and 3 for down load.

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 Trouble Shooting

Replacing the needle

In case the needle needs to be removed or replaced, proceed as follows:
1. Go to menu 6.2 and select 6.9.3 as shown below.

Warning
Contamination hazard if
contaminated blood enters
into open cut.
Always wear protective
gloves when handling 1143en.gif 1144en.gif
blood samples or parts of
the instrument that might
2. Press digit [1]The motor will now move the needle to its far down position
be contaminated with
(if it was not there already).
blood.
3. Switch off the instrument and open the front “door”.
4. Remove the upper needle locking ring only as indicated below.

Needle

Upper locking ring

Aspiration tube

1145.bmp

5. Pull the needle down and forwards to remove.

6. Clean or exchange the needle and remount in reverse order. Be sure to re-
connect the aspiration tube the correct way.

Note:
In the displayed menu 6.9.3, the positions 1, 2 and 3 stand for:
1 = Lowest position equals to open tube selection.
2 = Middle position equals to closed tube selection (Can only be reached from
position 3).
3= Upper position equals to penetrating position.

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 Trouble Shooting

14.10 Clogging in Aspiration Tube

In case the sample is not aspirated, a clogging within the aspiration tube might be
the source. To minimize these problems, inspect always the sample for visible
clogs before aspiration.
Please go to www.medonic.se/cleaning/ and download the movie sequence #1 Warning
how to rinse the aspiration tube with a syringe. Pin hazard
1. Switch off the instrument and open the front ‘door’. Always make sure that the
2. Remove the tube from the shear valve towards the blood detector device. instrument is switched off
when unclogging the aspi-
3. Connect a syringe filled with hypochlorit (ca. 4%) at the shear valve. ration tube.
4. Move the syringe plunger for- and backwards. Ignoring this may result in
personal injury from mov-
5. Restart the instrument and run a “blank”. ing parts in the instrument.

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 Index L
Leukemias 18
Levey-Jennings Plots 88
A List of materials included in delivery 39
A.C.D. blood 20 List of materials not included in standard delivery 39
address of distributor 8 LO 99
address of manufacturer 8 LPCR 32
Agglutinated erythrocytes 21 Lymphocyte 21
B M
Barcode reader 69 MCH 32
basophils 21 MCHC 32
BD 36 MCV 30, 81
Blood Controls 87, 88 Mean Cell Hemoglobin 13
Blood detector setup 68 Mean Cell Volume 13, 30
Mean Platelet Volume 13, 21, 31
C Micro Pipette 14, 57
CA530 Memory 15 MID 21, 23, 52, 89
CA620 Memory 15 MPA 75, 85
Chemotherapy 18 MPV 21, 31
Cold agglutinins 19 Multiple myeloma 18
control sample 15
Controls 81 N
Cryoglobulins 18 needle 102, 103
NG 35
D NM 36
Date of issue 8 NRBC 18
DE 34
discr. program 67 O
discriminator level 26 OF 100
discriminator setting 87, 102 Offset 35
Discriminator set-up 34 OM 36
Disposal 97
P
E Parameter Flags 33
Empty system 95, 96 PCT 32
PDW 31
F photometer 33
FD (Floating Discriminator) 35 Platelet Distribution Width 14
Fill system 95, 100 Platelet distribution width 31
Filling the system with reagents 46 PLT 14, 16, 19, 20, 23, 25, 27, 30, 31, 48, 65, 66, 70, 100
floating discriminator 65 Print all settings 67
Floating discriminator RBC/ PLT 15 Printer 15, 44, 49, 73, 78, 93
Floating Discriminator Settings 48 Printer setup menu CA620 73
Floating PLT/RBC discriminator settings 64
Fuse 12, 15 Q
QC memory 87
G
GRAN 21, 23, 29, 36, 52, 86 R
Granulocytes 21 RBC 16, 19, 20, 25, 27, 28, 30, 52, 65, 81
RDW 20, 86
H RDW% 30
HCT 19, 30, 52 RDWa 30
Hematocrit 13, 19, 30 Reagent 17, 40, 42, 71, 77
Hemolyzis 18, 20 Red Cell Distribution Width 20, 30
HGB 19, 32, 35, 36, 52, 54, 100 Red Cell Distribution Width (Absolute) 13
HGB measurement 99 RP 36
HI 99, 100

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 S
Sample Memory 61
SE 34, 36
Serial port setup 69
Setup Menu 64
Stand-By Mode 76
Statistical calculations 61, 62
storage conditions 7

T
TB 36
Thrombocytes 20
TL 34, 99
TM 36
Transport 95, 96
TU 34, 99
tubing 102

U
Units 51

W
Warning flags 15, 33
Warranty 9
Waste connection 40
waste container 97
waste liquid 10, 43
waste outlet 43
Waste pump 101
Waste tube 39
WBC 18, 19, 25, 27, 28, 36, 66, 81
WBC discr. Program 71
whole blood 9

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 Article no. 1504062

Boule Medical AB, P.O. Box 42056, SE-126 13 Stockholm, Sweden

Telephone: +46 8 744 77 00, Telefax: +46 8 744 77 20
E-mail: [email protected], Web: www.boule.se

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