User´s Manual - Medonic · PDF fileUser´s Manual Medonic CA620 + MPA + AD Medonic CA620 + MPA Medonic CA620 Medonic CA530 + MPA + AD Medonic CA530 + MPA Medonic CA530 Medonic CA620-CellGuard

User´s ManualMedonic CA620 + MPA + ADMedonic CA620 + MPAMedonic CA620Medonic CA530 + MPA + ADMedonic CA530 + MPAMedonic CA530Medonic CA620-CellGuard + MPA + ADMedonic CA620-CellGuard + MPA

03-11-24 3

ContentsPreface............................................................ 7

1 Safety Instruction........................................91.1 Intended Use .......................................................................... 91.2 Counter Indications ............................................................... 91.3 Warranty Limitations.............................................................. 91.4 General Warnings .................................................................101.5 Emergency Procedure .........................................................111.6 Warning Signs in Manual.......................................................111.7 Signs on Equipment .............................................................12

2 Specifications............................................ 132.1 General ...................................................................................132.2 Description of Available Parameters..................................132.3 Short-List of Specifications..................................................142.4 Parameter Ranges ...............................................................162.5 Reagents and Reagent Consumption .............................. 172.6 Limitations ..............................................................................182.7 Differences between CA620 and CA530

(9,16,20 parameters)........................................................... 22

3 Measuring Principles ............................... 253.1 RBC,WBC and PLT Concentration Detection ................ 253.2 Sizing RBC, WBC and PLT ................................................. 273.3 Counting Time RBC & WBC .............................................. 283.4 WBC Differentials ................................................................. 283.5 MCV (Mean Cell Volume RBCs)........................................ 303.6 RDW% (Red Cell Distribution Width)................................. 303.7 RDWa (Red Cell Distribution Width Absolute) ................. 303.8 HCT (Hematocrit)................................................................. 303.9 PLT (Platelets)....................................................................... 303.10 MPV (Mean Platelet Volume)..............................................313.11 PDW (Platelet distribution width) ........................................313.12 LPCR (Large Platelets)........................................................ 323.13 PCT (Packed Platelet Volume) .......................................... 323.14 HGB (Hemoglobin Concentration) ................................... 323.15 MCH (Mean Cell Hemoglobin) .......................................... 323.16 MCHC (Mean Cell Hemoglobin Concentration)............. 32

4 Parameter Flags....................................... 334.1 TU (Time-out Upper Detector) .......................................... 344.2 TL (Time-out Lower Detector)........................................... 344.3 SE (Statistical Error) ............................................................. 344.4 DE (Distribution Error).......................................................... 344.5 FD (Floating Discriminator) ................................................. 354.6 OF (Offset error HGB) ......................................................... 354.7 LO (Low blank level HGB)................................................... 354.8 HI (High blank level HGB).................................................... 354.9 NG (Negative HGB) ............................................................. 354.10 SE (Statistical error HGB).................................................... 364.11 TB (Air bubbles).................................................................... 36

4 03-11-24

4.12 NM, OM, TM, BD (WBC Differential Flags) .......................364.13 RP (Red Cells Present) ........................................................364.14 EC (Expired control).............................................................374.15 Comments on Flagging Capabilities .................................37

5 Installation.................................................395.1 Unpacking the Instrument ..................................................395.2 Working Conditions .............................................................395.3 Mechanical Check and Set-Up.......................................... 415.4 Front Panel and Command Keys......................................445.5 Filling the system with reagents.........................................46

6 Initial System Configuration......................476.1 CA620-CellGuard ................................................................476.2 Setting up the CA620-CellGuard

for Pre-Donor Screening.....................................................476.3 Setting up the CA620-CellGuard

for PLT Concentrate ............................................................486.4 CA620/530 ...........................................................................486.5 Setting Date and Time.........................................................496.6 Printer Configuration............................................................496.7 Select Language .................................................................. 516.8 Select Units ........................................................................... 51

7 Routine Operation .....................................537.1 Background Check..............................................................537.2 Analysing the Sample (Open Tube) ..................................547.3 Analyzing the Sample (Pre-Dilute).....................................567.4 Analysing the Sample (Micro Pipette Adapter, MPA).....577.5 Analysing the Sample (Cap Piercing Device) ..................587.6 Advanced User Options (CA620-CellGuard) ..................60

8 User Interface ........................................... 618.1 Sample Memory................................................................... 618.2 Setup Menu...........................................................................648.3 Setup Menu 2 .......................................................................68

9 Warning Displays ......................................759.1 Warnings Related to the MPA and Pre-Dilute Inlet.........759.2 Stand-By Mode ....................................................................769.3 Reagent Empty .................................................................... 779.4 Printer and Serial Output .....................................................789.5 Auxiliary Warnings/Messages ............................................79

10 Calibration and controls ........................... 8110.1 Introduction ........................................................................... 8110.2 Use of Calibrators and Controls ........................................ 8110.3 Calibration on a Known Sample ........................................8210.4 Calibration Through a Certified Calibrator........................8310.5 Calibration on Pre-Diluted Capillary Blood .......................8510.6 Calibration of the MPA.........................................................8510.7 Calibration of RDW, LYMF and GRAN ..............................86

03-11-24 5

11 QC and Blood Controls .............................8711.1 Introduction........................................................................... 8711.2 Initializing the Levey-Jennings Plots and Functions ....... 8711.3 Use of Blood Controls and Levey-Jennings Plots ......... 8811.4 Initialization and Use of X-B Function................................ 8911.5 Display of Blood Control Data.............................................91

12 Printer and Serial Output ......................... 9312.1 Selecting the Correct Printer Type ................................... 9312.2 The Serial Output/Hardware Connections ...................... 9312.3 The Serial Output Format ................................................... 94

13 Maintenance, Shut-Down & Transport.... 9513.1 Daily Maintenance ............................................................... 9513.2 Monthly Maintenance ......................................................... 9513.3 Three (3) Month Maintenance........................................... 9513.4 Short Term Transport.......................................................... 9613.5 Re-packaging and Long Term Transport........................ 9613.6 Permanent Shut-Down and Storing the Instrument...... 9713.7 Disposal information............................................................ 97

14 Trouble Shooting...................................... 9914.1 Counting Time HI (TU & TL) ............................................... 9914.2 Counting Time LO................................................................ 9914.3 HGB Value Flagged with LO............................................... 9914.4 HGB Value Flagged with HI .............................................. 10014.5 HGB Value Flagged with OF ............................................ 10014.6 High Background PLT....................................................... 10014.7 Indication Number XXX Displayed.................................... 10114.8 Cell Diff. Only on a Few Samples..................................... 10214.9 Cap Piercing Device .......................................................... 10214.10Clogging in Aspiration Tube ............................................. 104

Index............................................................ 105

6 03-11-24

03-11-24 7

Preface

Name of product, serial number and software versionThis 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”

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 conditionsGeneral 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 trainingAdditonal 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 consumablesThese 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.

1177en.gif

A

1176en01

8 03-11-24 1176en01

Name and address of manufacturer:Boule Medical ABP.O. Box 42056SE-126 13 StockholmSweden

Telephone: +46 8 744 77 00

Fax: +46 8 744 77 20

e-mail: [email protected]

Name and address of distributorDistributors are listed on:

http.//www.boule.se

StandardsEN591:2001IVD 98/79/EGSSEN 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 number1504062en

Date of issue

August 2003

03-11-24 9

1 Safety Instruction

1.1 Intended Use

CA620/530 and CA620-CellGuardThe 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.

1070en01

Safety Instruction

10 03-11-24 1070en01

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 WarningsBoule 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 materialBecause 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.

Safety Instruction

1070en01 03-11-24 11

• 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 ManualThese 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.

Indicates operating procedures, practices and so on that could result in damage or destruction of equipment if not strictly observed.

Emphasizes operating procedures, practices and so on that must be followed to avoid erroneous results.

Warning

Caution

Important

Safety Instruction

12 03-11-24 1070en01

1.7 Signs on Equipment

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.

4

Front/side view of the Instrument

Open door view of the Instrument

1

Back view of the Instrument

1013.jpg

1022.jpg

1040.jpg

2

2

3

03-11-24 13

2 Specifications

2.1 GeneralThe 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-centage

(LYMF)

• The MID-sized Cells (e.g.Monocytes) in absolute number and percentage

(MID)

• The Granulocytes concentration in absolute number and per-centage

(GRAN)

• The Red Cell Distribution Width (Absolute) (RDWa)

1001en01

Specifications

14 03-11-24 1001en01

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.

Note: PCT, LPCR, RDWa and PDWa are not established parameters. Their use should be restricted to research or investigational use only.

2.3 Short-List of Specifications

• The Platelet Distribution Width (Absolute) (PDW)

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

• The Platelet Packed Volume (PCT)

Measuring principle RBC, WBC, PLT

Impedance

Measuring principle HGB Cyanide free method 540nmDiscriminator Floating programmableSampling system Closed shear valveParameters 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 (open tubes)

approx. 125µl

Aspirated blood volume (closed tubes)1

approx. 200 µl

Blood volume using the Micro Pipette Adapter

20 µl

Pre-diluted mode 1:200 to 1:250 using min. 20µl bloode.g. 20 µl to 5 µl diluent30 µl to 6 µl diluent40 µl to 8 µl diluent

CA530 Screen 2x40 character LCDCA620 Screen Graphic LCD displayKeyboard NumericalTotal cycle time approx. 73 seconds

ImportantApplicable for CA620-CellGuard:

The MPA is intended to be used for pre-donor screen-ing. Using the MPA for PLT concentrate may re-duce the accuracy of the result.

Specifications

1001en01 03-11-24 15

Sample display and print after approx. 53 secondsPrinter External, IBM proprinter, Epson format,

HP-PCL or DPU411-type II /DPU414supplied by Boule-Medical

CA530 Memory >350 samplesCA620 Memory >200 samples and 600 control samplesCA530 QC capability SD, CV, XmCA620 QC capability SD, CV, Xm, Levey-Jennings plots and

X-B with approx. 10.000 samples historyHGB correction on high WBC counts

Yes

Warning flags on parameter abnor-malities

Yes

Floating discriminator RBC/ PLT Yes (position printed)Mathematical 3-part diff. WBC calc. YesAutomatic HGB blank on each sample

Yes

Carry Over < 1%Bar-code reader input YesSerial output2 YesMains voltage / Fuses 230V Fuse 5x20mm T2A

120V Fuse 5x20mm T4AMains voltage tolerances +15% / -15% Power consumption max 250 VAPower consumption (stand-by) max 50 VAFrequency 50/60 HzBuilt-in test /adjustment programs YesTemperature 18-32C, 64 - 90FHumidity (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 device2. Computer & connection must conform to standard EN 60950

Specifications

16 03-11-24 1001en01

2.4 Parameter RangesLinearity +/-1% within the following range:WBC 0.5 - 80.0RBC 0.5 - 9.99MCV 55 - 130PLT 30 - 999HGB 0.5 - 55.0PLT-Concentrate mode(RBC < 0.3 and measured on a Latex solution)

30-6999 (applicable on CA620-Cellguard only)

Measuring range:

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

(applicable on CA620-Cellguard only)Correlation1

1. Using Coulter AcT and Abbot CD1600 as reference

RBC, WBC R > 0.97PLT R > 0.90HGB R > 0.99MCV R > 0.90Reproducibility (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 2.0RBC 4.52 0.85MCV 89.4 0.5PLT 252 3.2HGB 13.9 0.8

Specifications

1001en01 03-11-24 17

2.5 Reagents and Reagent ConsumptionThe 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:

The approximate consumption can be calculated from the graph below and is de-pending on the number of samples/day. The figures stated are indicative only and 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

Lyzer consumption

For additional information regarding cleaning solutions; please refer to Mainte-nance, Shut-Down & Transport on page 95.

Diluent approx. 19 ml/sample

Lyzer approx. 9.5 ml/sample

CautionUse only by Boule autho-rized reagents.

Erroneous results and damage of the system may occur if other reagents are used.

Diluent consumption CA620 vs # samples

0

5

10

15

20

25

30

35

0 50 100 150 200

Number of Blood_samples/Day

Dilu

en

tco

nsu

mp

tio

n/sam

ple

(ml)

1014.eps

Lyzer consumption CA620 vs # Samples

0

2

4

6

8

10

12

14

16

18

20

0 50 100 150 200

Number of Blood_samples/Day

Lyzer

co

nsu

mp

tio

n/

sam

ple

(ml)

1015.eps

Specifications

18 03-11-24 1001en01

2.6 LimitationsVerification 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.

NRBCImmature 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 CellsIn 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 myelomaThe precipitation of proteins in multiple myeloma patients may give elevated WBC counts.

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

LeukemiasThis 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.

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

CryoglobulinsIncreased 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.

Specifications

1001en01 03-11-24 19

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 cellsThis 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 agglutininsIgM 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 WBCThe diluted sample should be centrifuged and the supernatant fluid checked on a spectrophotometer for turbidity.

2. Elevated lipidsElevated 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 bloodThe 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

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

PLTExcessive 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.

Specifications

20 03-11-24 1001en01

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

ChemotherapyCytotoxic 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.

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

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

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

Platelet agglutinationClumped 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.

Specifications

1001en01 03-11-24 21

MPV (Mean Platelet Volume)

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

Small erythrocytesVery 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 erythrocytesThis 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.

ChemotherapyMay also effect the size of the PLTs

EDTANote 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.

Specifications

22 03-11-24 1001en01

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.

Specifications

1001en01 03-11-24 23

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:

CA530-9

CA530-16

CA530-20

CA620-16

CA620-20

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

Specifications

24 03-11-24 1001en01

03-11-24 25

3 Measuring Principles

3.1 RBC,WBC and PLT Concentration DetectionDetection 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.

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.

1017.wmf

Sampling valve

1016en01

Measuring Principles

26 03-11-24 1016en01

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.

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.

1018.tif

electrical current

electrodes

Flow direction

cells

A

A=Aperture

1019.tif

glass tube

stop detector

fixed volume

start detector

flow


1016en01 03-11-24 27

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 PLTThe 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.


28 03-11-24 1016en01

3.3 Counting Time RBC & WBCThe 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 DifferentialsWithin 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.


1016en01 03-11-24 29

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.

1020.tif

fixed discriminators

4 hours old

fresh” blood

LYMF GRAN

Volume (fl)

n

1021.tif

LYMF

n

GRAN

MID cells

Volume (fl)


30 03-11-24 1016en01

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).


1016en01 03-11-24 31

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.


32 03-11-24 1016en01

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.

03-11-24 33

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 populations

Examine size distribution RBC/PLT or WBC

See DE (Distribution Error) on page 34.

FD Insufficient cell separation RBC/PLT

Examine size distribution RBC/PLT

See FD (Floating Dis-criminator) on page 35.

OF HGB photometer offset out of range.

Wait 15-30 minutes and restart instrument.

If persist See OF (Offset error HGB) on page 35.

LO HGB photometer lamp intensity too low

See comment If persist See LO (Low blank lev-el HGB) on page 35.

HI HGB photometer lamp intensity too high

See comment If persist See HI (High blank lev-el HGB) on page 35.

NG Negative HGB value Run “Prime” from menu 8.1

If persist See NG (Negative HGB) on page 35.

SE irregular HGB measurement

Re-run sample If persists on all sam-ples

See SE (Statistical error HGB) on page 36.

TB Air bubbles in system Run ‘Prime’ from menu 8.1

If persist See TB (Air bubbles) on page 36.

NM,OM,TM,BD

WBC differential abnor-mality

Examine sample by refer-ence method

See NM, OM, TM, BD (WBC Differential Flags) on page 36.

RP Red cells present in PLT concentrate (CA620-Cell-Guard only)

Disregard PLT parameter result

See RP (Red Cells Present) on page 36.

EC Blood control expired Use new blood control

See EC (Expired con-trol) on page 37.

1002en01

Parameter Flags

34 03-11-24 1002en01

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.

Parameter Flags

1002en01 03-11-24 35

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)This error flag is related to the HGB parameter only. During a “Power On” or an exit from the Stand-by mode the offset voltage in the photometer system is mea-sured. If the offset limits are violated, this flag is set. The ”OF” flag might also occur during the installation process. In such case, the analyzer was probably ex-posed to high temperature changes and condensation may have occurred.

4.7 LO (Low blank level HGB)This error flag is related to the HGB parameter. During each sample a blank is 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.

ImportantLet the analyzer warm up ca. 1-2 hours and proceed with the installation proce-dure. In case the ‘OF’ flag persists, HGB values will be incorrect. Call your au-thorized service depart-ment.

Parameter Flags

36 03-11-24 1002en01

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.

Parameter Flags

1002en01 03-11-24 37

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 CapabilitiesAll 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.

Parameter Flags

38 03-11-24 1002en01

03-11-24 39

5 Installation

5.1 Unpacking the InstrumentThe 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.

Unpack the instrument and check that the following items are included:

List of materials included in deliveryUsers Manual 1

Waste tube 1

Inlet tube with detector for Isotonic diluent. 1

Inlet tube with detector for hemolyzing reagent. 1

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 ).

List of materials not included in standard deliveryPrinter and printer- or computer connection cable.

Printer paper.

Additional software for patient sample managing systems.

Barcode reader.

Reagents, blood controls, calibrators and cleaners.

5.2 Working Conditions

Mains Supply EnvironmentThe 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.

Guidelines are given in the “Service Manual” section “Installation auxilliary de-vices”. Contact your authorized distributor in such a case.

An abrupt interruption of the mains supply will not damage the instrument as all calibration constants and other parameters necessary for the correct working of the instrument are protected against mains supply loss.

ImportantThe following procedures must be followed exactly. Boule has no responsibility in case of faulty or errone-ous installation. Possible errors that may occur are:

- Indication numbers- Erroneus parameter re-sults- Excessive service needs

WarningElectrical shock hazard

Installation of external electrical equipment such as CVT must only be car-ried out by authorized ser-vice engineers. Violating this might result in injuries and/or loss of life and/or erroneous parameter re-sults.

WarningElectrical shock hazard

The instrument must only be connected to a ground-ed mains supply. Violating this, might result in injuries and/or loss of life and/or erroneous parameter re-sults.

1003en01

Installation

40 03-11-24 1003en01

LocationThe 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.

The instrument can work correctly within the stated temperature and humidity range however, to minimize the risk of bacterial growth in the reagent packages, it is strongly recommended to keep the laboratory at a temperature of approx. +22°C (72°F).

)

Reagent packagesReagent 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 the Lyzer container preferably at the same level as the instrument (e.g. the same table).

Waste connectionThe instrument has an open waste outlet and can be connected to a central waste system within the laboratory. The waste outlet, or container, must always be at a lower level than the instrument. National and/or local regulations must be fol-lowed in all cases.

ImportantOperating the instrument in an environment over +32°C (90°F) increases service-needs as well as degradation of sample specimen.

1178.bmp

A

WarningContamination hazardBecause no test method can offer complete assur-ance that HIV, Hepatitis B or C viruses, or other in-fectious agents are absent, the waste should be han-dled at the Biosafety Level 2 as recommended for any 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)

Installation

1003en01 03-11-24 41

5.3 Mechanical Check and Set-Up

RecommendationInstallation of the instrument should be carried out by the authorized distributor.

Instrument installation1. Lift the instrument and place it on the chosen location as shown below.

Be careful not to stress the front door of the instrument.

2. Open the front door of the instrument.

3. Locate the cover plate of the tubing system.

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

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

1023.tif

1024.tif

Installation

42 03-11-24 1003en01

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

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.

8. Re-assemble the front cover in reverse order. Be sure to reconnect the ground-wire!

Reagent pack installation 1. Place the reagent pack in the proper place. See Reagent packages on page

40.

2. Put the probes as shown below (the example shows the lyzer container).

1025.tif

1026.tif

Transport guides

ImportantOne 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 operate correctly in case a transport guide is not re-moved. Possible conse-quences of not removing all transport guides are:

Indication numbers, incor-rect parameter results and/or incorrect counting times.

1027.bmp

Installation

1003en01 03-11-24 43

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

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

5. Connect the waste outlet to a proper container or open drain. See Waste connection on page 40.

Final set-up1. Locate the serial number plate at the rear and check that the mains voltage

and frequency corresponds to your local mains supply outlet.

2. Insert the power cable and connect to the mains supply. A short beep is heard where after the instrument will perform a self-check that normally takes 2 minutes. (Maximum15 minutes in case of condensation).

1028.tif

1029.tifCautionBio hazard

The end of the waste tube must be at a lower level than the instrument itself.

Not following this might lead to improper instru-ment functions and/or waste liquid flowing back-wards into the instrument.

Installation

44 03-11-24 1003en01

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.

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 KeysThe front panel of the instrument consists of:

1. Numerical keyboard

2. Display

3. [Print]

4. [Menu] button

5. Arrow keys,

1030.tif

1031.tif

1

4

3

2

5

Installation

1003en01 03-11-24 45

Using the keyboardNumerical 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.

[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.

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.

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

1032.tif

1033.tif

1034.tif

1035.tif

Installation

46 03-11-24 1003en01

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 reagentsAfter 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].

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.

1037en.gif1036en.gif

03-11-24 47

6 Initial System Configuration

6.1 CA620-CellGuardThe 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 ScreeningThe 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.


1004en01

Initial System Configuration

48 03-11-24 1004en01

6.3 Setting up the CA620-CellGuard for PLT ConcentrateThe 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.

6.4 CA620/530The 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.

1038en.gif 1041en.gif


1004en01 03-11-24 49

6.5 Setting Date and Time1. Press [Menu] until the main menu is displayed and select menu 5.

2. Scroll to line 5.5.

3. Press [Enter]

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.

6.6 Printer ConfigurationIn 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.

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


1044en.gif

1045en.gif


50 03-11-24 1004en01

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.


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.


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).

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).

1046en.gif


1004en01 03-11-24 51

6.7 Select LanguageThe 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)

6.8 Select UnitsThe 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.

1047en.gif

1048en.gif


52 03-11-24 1004en01

Select number:

1 2 3 4 5 6

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/mm3 109/l 109/l 109/l 103/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% % % % % % %

03-11-24 53

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.

Applicable for CA620-CellGuardThe 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 CheckThe 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.

1050en.gif

1051en.gif

1049en.gif

1005en01

Routine Operation

54 03-11-24 1005en01

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”:

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.

The display shows the following sequences:

RBC 0.01

WBC 0.1

HGB 0.1

PLT 10

1052en.gif

1053.bmp

WarningContamination hazard if contaminated blood enters into open cut.

Always wear protective gloves when handling blood samples.

(Gloves in the picture are not shown for clarity rea-sons only.)

Last Sample (= blank) Aspirating sequence


Routine Operation

1005en01 03-11-24 55

The instrument switches now to the following menu.

Although not mandatory, enter the ID of the sample with the numerical keys. Note that a positive identification of a sample is highly recommended to avoid erroneous patient parameter reporting. A maximum of 15 digits are allowed in the ID field. In case the optional Bar-Code reader is installed, simply scan in the ID barcode from the sample tube.

After approx. 30 seconds; the CA620 will switch to the INTRA mode as shown below:

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.

ImportantRemove the sample from the open inlet aspiration needle when the display has changed from “Aspi-rating” to “Counting cycle in progress”. Not removing the sample could result in incorrect washing sequence of the aspiration needle.

1056en.gif

1057en.gif

1058.gif

Upper “normal” range setting

Lower “normal” range setting

Rate

Routine Operation

56 03-11-24 1005en01

Sample displayed after ca. 53 seconds from aspiration:

7.3 Analyzing the Sample (Pre-Dilute)Any dilution rate between 1:200 and 1:250 can be used under the condition that the minimum total volume is 5ml and the maximum volume 8 ml. It is obvious that always the same dilution rate must be chosen as any reproducibility error in 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.

1059en.gif

ImportantThe instrument is ready to accept the next sample af-ter the flashing display cur-sor in the upper left display corner disappears.

Entering the next sample before the flashing cursor disappears will result in er-roneus parameter results for the next sample.

1060en.gif

Routine Operation

1005en01 03-11-24 57

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:

3. Puncture, using the Boule Micro Lancet.

4. Aspirate the sample as shown below.

5. Insert the micro pipette (capillary) in the longest tube of the MPA device.

1061en.gif

1062.jpg


Always wear protective gloves when handling blood samples.

(Gloves in the picture are not shown for clarity rea-sons only).

1063.jpg

CautionAlways insert the capillary tube in the longest metal tube of the MPA.

Inserting the capillary tube in the shortest metal tube of the MPA might damage the MPA or break the cap-illary.

1064.jpg

Routine Operation

58 03-11-24 1005en01

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

Note: 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 length of ca. 73 mm.

1. Rotate the wheel to a position that fits the dimension of the tubes you are using. The positions can hold auxiliary adapter devices that can be ordered from Boule to fit your local needs.

1065.jpg

ImportantFill the micro pipette com-pletely and wipe off the ex-cessive blood on the outside surface. Ignoring this instruction might cause incorrect and non-reproducable results.

ImportantMaximum length of tube 77 mm. Lengths exceeding this dimension will not fit into the adapter.

Use only tubes with a max-imum length of 77 mm


Always wear protective gloves when handling blood samples

(Gloves in these pictures are not shown for clarity reasons only.)

1066.bmp

Routine Operation

1005en01 03-11-24 59

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

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

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.

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

1067.bmp

CautionAvoid 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

Routine Operation

60 03-11-24 1005en01

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.

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.

1069en.gif

03-11-24 61

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.

8.1 Sample MemoryEntering 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.

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.

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.

1071en.gif

1072en.gif

1073en.gif

1006en01

User Interface

62 03-11-24 1006en01

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:

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.


User Interface

1006en01 03-11-24 63

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.

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-CellGuardWe 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.

1076en.gif

User Interface

64 03-11-24 1006en01

8.2 Setup MenuWithin 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.

Set parameter normal rangesIn 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.

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



User Interface

1006en01 03-11-24 65

CA620-CellGuard1. 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”.

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/RBCScroll 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 modeIn the example below, PROG 1 is shown by pressing [Enter] and the settings for the floating discriminator are displayed.

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



User Interface

66 03-11-24 1006en01

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

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


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 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. WBCScroll 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.



ImportantDo not alter PLT conc. mode. This must be “1” to enable the correct sample aspiration mode.

Setting PLT conc. mode to “0” will aspirate the sam-ple for 10 seconds and macro Platelets up to 60fl will not be counted.


User Interface

1006en01 03-11-24 67


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.

Print all settings1. 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.

1091en.gif

1092en.gif

User Interface

68 03-11-24 1006en01

8.3 Setup Menu 21. Scroll with the up-down arrow key to “Setup menu 2” (menu 5.10).

2. press [Enter].


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 IDRefer 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.

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.

1093en.gif


User Interface

1006en01 03-11-24 69

Applicable for CA620 CellGuardScroll 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 setupIn 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].


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

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.

1096en.gif

1097en.gif

User Interface

70 03-11-24 1006en01

PLT offs and High altitude compIn 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).

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

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:

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+.

777+ Boule Low

888+ Boule Norm

999+ Boule High

1098en.gif

1000en.gif

User Interface

1006en01 03-11-24 71

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 typeThis 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.

Set PROG namesAs 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:

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.


CA620-CellGuard CA620/530


User Interface

72 03-11-24 1006en01

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.


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:

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 parametersThe 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]

1103en.gif


CA620-CellGuard CA620/530

User Interface

1006en01 03-11-24 73


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.

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 CA620This menu is used for advanced printer options and user definable printout pro-gramming.

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 startThis 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.

1105en.gif


1108en.gif

User Interface

74 03-11-24 1006en01

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

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.

1109en.gif

03-11-24 75

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

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.

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

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.

1110en.gif

1111en.gif


1114en.gif

1008en01

Warning Displays

76 03-11-24 1008en01

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.

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 ModeThis 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].

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.

1115en.gif



Warning Displays

1008en01 03-11-24 77

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.

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

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

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.

1120en.gif

1121en.gif

1122en.gif 1123en.gifs

Warning Displays

78 03-11-24 1008en01

9.4 Printer and Serial Output

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

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.

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



1127en.gif

Warning Displays

1008en01 03-11-24 79

9.5 Auxiliary Warnings/Messages

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.

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.


1131en.gif

Warning Displays

80 03-11-24 1008en01

03-11-24 81

10 Calibration and controls

10.1 IntroductionThe 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 HGB and HCT. This parameter should be in the range of 30 - 37 g/dl. Daily mean values of the samples should always be 32 - 36 g/dl.

RBC, WBC and PLTCalibration of the above-mentioned parameters is done at the factory with refer-ence standard instruments and volumetric measuring methods. The metering tube is mechanically constant and will remain stable.

MCVCalibration 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 ControlsThe 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.

To ensure the accuracy of the values obtained whenever commercial controls are used:

1. Always re-suspend according to the manufacturer's recommendations.

2. Never use an open vial longer than recommended by the manufacturer or subject any vial to excessive heat or agitation.

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”.

ImportantDo not calibrate the MCV parameter using commer-cial controls with values given for other analyzers, unless approved by Boule.

Not following this might lead to incorrect MCV val-ues on processed samples

ImportantUse the special ID func-tion to identify the specific control blood. See Print control blood id:s on page 70.Not doing so might lead to incorrect WBC values.

1009en01

Calibration and controls

82 03-11-24 1009en01

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.

.

10.3 Calibration on a Known SampleThe following procedure can be used in case no Hematology Blood Calibrator is available or if the recommended transport conditions of such cannot be met.

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.


Always wear protective gloves when handling blood samples

ImportantDry the aspiration pipette manually on the outside at each control blood run and do not push the con-trol or calibrator tube against the upper washing device. See pictures.

Not following this disci-pline might give dropping values for the RBC, HGB, PLT and WBC parameters.

1132.bmp 1133.bmp 1134.bmp

Dry the aspiration pipette manually

Correct sample handling

1136.bmp

Do not push the sample tube against the washing device

1135.bmp


1009en01 03-11-24 83

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

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%

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 CalibratorRecommended 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.

Please note that calibration is only possible on measured parameters e.g.:RBC, WBC, MCV, HGB and PLT.

Use a Boule certified PLT-Concentrate calibrator to calibrate the CA620-Cell-Guard for PLT concentrates on the PLT-C and MPV-C parameters. The proce-dure is identical as described below.

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

WBC < 2.8%

RBC < 1.2%

PLT < 5.5%

MCV < 0.8%

HGB < 1.2%


ImportantDo not calibrate the in-strument using commer-cial controls or calibrators with values given for other analyzers.

This might lead to incor-rect calibration of the in-strument.


84 03-11-24 1009en01

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:

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:

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.

WBC < 4%

RBC < 1.8%

PLT < 6%

MCV < 1%

HGB < 1.8%

MPV < 5% (if applicable)

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

1139en.gif


1009en01 03-11-24 85

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”.

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 BloodCalibration 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 MPAThe 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.



86 03-11-24 1009en01

10.7 Calibration of RDW, LYMF and GRANThe 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:

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 calibrationIn 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.

1142en.gif

03-11-24 87

11 QC and Blood Controls

11.1 IntroductionThe 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.

Note:Refer to section “Calibration” how to handle the blood control and how to dry the aspiration pipette manually in order not to contaminate the blood controls. See Use of Calibrators and Controls on page 81.

CA620 and CA530 without bar-code reader.

Blood controls must be identified with the ID number 777+ (low), 888+(norm) and 999+ (high). The “+” sign is entered by pressing the right arrow key.

PROG8 (CNTRL8) is used for the definition of discriminator settings and “nor-mal range” settings. Note that the Levey-Jennings plots are not available in case the bar-code reader is not installed.

11.2 Initializing the Levey-Jennings Plots and FunctionsTo 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.


ImportantDo not forget to dry the aspiration pipette manually on the outside at each con-trol blood run and do not push the control sample tube against the upper washing device.



1156en01

QC and Blood Controls

88 03-11-24 1156en01

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.

.

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 blood control and how to dry the aspiration pipette manually in order not to con-taminate the control.

Enter the control by reading the ID with the bar-code scanner from the sample tube or enter the blood control ID manually and terminate with the “+” sign en-tered with the right arrow key. Aspirate the control sample and wait for the re-sults.

The CA620 will identify this ID and match the results with the previous defined control data, see Initializing the Levey-Jennings Plots and Functions on page 87 above. In case a parameter is outside the defined range, a “*” sign is dis-played in front of the parameter value. Press [Print] to print out the results. The 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.


ImportantDo not forget to dry the aspiration pipette manually on the outside at each con-trol blood run and do not push the control sample tube against the upper washing device.



1156en01 03-11-24 89

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

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”.

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 FunctionThe 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.




90 03-11-24 1156en01

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%.

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

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.

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.





1156en01 03-11-24 91

11.5 Display of Blood Control DataTo 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.

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.



92 03-11-24 1156en01

03-11-24 93

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

Press [Print] to printout a list of available formats.

Note: Extended printer format settings and user definable print layouts are available. Please refer to appendix 530-30-205 for detailed information how to set up a user definable format. This appendix is available from your authorized distributor in the English language only and requires basic understanding of printer protocol, formats and font definitions.

12.2 The Serial Output/Hardware ConnectionsThe 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.

ImportantIf an IBM, Epson or HP compatible printer is used, it is of great importance for the correct printing that the actual printer is supporting the selected data format. Incorrect printing might follow if an improper format or printer is selected.

1150en.gif

1010en01

Printer and Serial Output

94 03-11-24 1010en01

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

PC Computer using a 9 pin RS232

12.3 The Serial Output FormatThe 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

Cable end instrument9 Pin Female DSUB

Cable end PC25 Pin Female DSUB

2------------------------------------------------------------------- 33------------------------------------------------------------------- 25------------------------------------------------------------------- 77------------------------------------------------------------------- 48------------------------------------------------------------------- 5

Cable end instrument9 Pin Female DSUB

Cable end PC9Pin 9 DSUB

2------------------------------------------------------------------- 23------------------------------------------------------------------- 35------------------------------------------------------------------- 57------------------------------------------------------------------- 78------------------------------------------------------------------- 8

03-11-24 95

13 Maintenance, Shut-Down & Transport

13.1 Daily MaintenanceThe 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 outside of the instrument.

1. Clean the outside of the aspiration pipette with a pure alcohol solution. This removes possible traces of proteins, bacteria or viruses and increases the ef-fectiveness of the pipette auto-cleaning procedure.

2. Remove possible traces of salt crystals or blood with a disinfecting solution.

13.2 Monthly MaintenanceThe monthly cleaning procedure has the purpose of securing the correct func-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.

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

Report any unusual salt crystal built-up to your authorized dealer.

13.3 Three (3) Month MaintenanceTo increase the life time of the tubes in the instrument, the following cleaning procedure is strongly recommended.

1. Put both reagent probes in a bottle with “Enzymatic Cleaner”, authorized by Boule.

2. Execute Menu 8. 2 (Fill system).

3. Wait ca. 30 minutes.

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).


Always wear protective gloves when handling blood samples or parts of the instrument that might be contaminated with blood.

CautionDo not disconnect the in-strument from the mains-supply as the analyzer per-forms automatic self-check cycles every 4th hour to prevent clogging and bacterial growth in the system. Please call your au-thorised distributor in case the instrument has to be powered off during a peri-od longer than 4 days.Not doing so might lead to bacterial growth or block-ages in the system.

1011en01

Maintenance, Shut-Down & Transport

96 03-11-24 1011en01

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 transport. It is important that the ambient temperature is never below 5°C (41°F). Temperatures below the freezing point (of water) can easily destroy essential parts of the instrument.

Humidity over 95% can also cause serious damage to the instrument when it is switched on directly after transport. If condensation has occurred, the instrument should be warmed up at normal ambient temperature for at least 3 hours before it is switched on again.

The above transport procedure may only be carried out if the instrument is going to be installed within 12 hours.

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 TransportWhenever 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.

CautionThe transport according to this procedure should only be carried out if the instru-ment is going to be rein-stalled within 12 hours.

Not following these guide-lines might lead to block-ages in the system and/or incorrect functioning dur-ing the re-installation.


1011en01 03-11-24 97

13.6 Permanent Shut-Down and Storing the InstrumentTo 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

Manufacturers recommendationPlace the instrument close to a waste container suitable for disposal of used reagents.

Check that the drainage is suitable for disposal of chemical and biological waste.

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

WarningContamination hazard.

Always wear protective gloves and/or goggles when handling infectous or potentially infectous materials.


98 03-11-24 1011en01

03-11-24 99

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 LOThe “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.

1012en01

Trouble Shooting

100 03-11-24 1012en01

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 HIThe '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 OFThis 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 PLTHigh 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.

Trouble Shooting

1012en01 03-11-24 101

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

Indication = 2The 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 = 9Auto HGB adjustment failed. The cause might be a broken lamp. Contact service department.

Indication = 100-199One 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 = 200-299The 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 - 399There was a power failure in a cycle, or a cycle was aborted due to a previous in-dication.

Trouble Shooting

102 03-11-24 1012en01

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 = 900-999Memory 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 SamplesTo 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 DeviceIn 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 needleIf 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.

Trouble Shooting

1012en01 03-11-24 103

Replacing the needleIn 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.

2. Press digit [1]The motor will now move the needle to its far down position (if it was not there already).

3. Switch off the instrument and open the front “door”.

4. Remove the upper needle locking ring only as indicated below.

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.



Always wear protective gloves when handling blood samples or parts of the instrument that might be contaminated with blood.

1145.bmp

Needle

Upper locking ring

Aspiration tube

Trouble Shooting

104 03-11-24 1012en01

14.10 Clogging in Aspiration TubeIn 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 how to rinse the aspiration tube with a syringe.

1. Switch off the instrument and open the front ‘door’.

2. Remove the tube from the shear valve towards the blood detector device.

3. Connect a syringe filled with hypochlorit (ca. 4%) at the shear valve.

4. Move the syringe plunger for- and backwards.

5. Restart the instrument and run a “blank”.

WarningPin hazard

Always make sure that the instrument is switched off when unclogging the aspi-ration tube.

Ignoring this may result in personal injury from mov-ing parts in the instrument.

105 03-11-24

IndexAA.C.D. blood 20address of distributor 8address of manufacturer 8Agglutinated erythrocytes 21

BBarcode reader 69basophils 21BD 36Blood Controls 87, 88Blood detector setup 68

CCA530 Memory 15CA620 Memory 15Chemotherapy 18Cold agglutinins 19control sample 15Controls 81Cryoglobulins 18

DDate of issue 8DE 34discr. program 67discriminator level 26discriminator setting 87, 102Discriminator set-up 34Disposal 97

EEmpty system 95, 96

FFD (Floating Discriminator) 35Fill system 95, 100Filling the system with reagents 46floating discriminator 65Floating discriminator RBC/ PLT 15Floating Discriminator Settings 48Floating PLT/RBC discriminator settings 64Fuse 12, 15

GGRAN 21, 23, 29, 36, 52, 86Granulocytes 21

HHCT 19, 30, 52Hematocrit 13, 19, 30Hemolyzis 18, 20HGB 19, 32, 35, 36, 52, 54, 100HGB measurement 99HI 99, 100

LLeukemias 18Levey-Jennings Plots 88List of materials included in delivery 39List of materials not included in standard delivery 39LO 99LPCR 32Lymphocyte 21

MMCH 32MCHC 32MCV 30, 81Mean Cell Hemoglobin 13Mean Cell Volume 13, 30Mean Platelet Volume 13, 21, 31Micro Pipette 14, 57MID 21, 23, 52, 89MPA 75, 85MPV 21, 31Multiple myeloma 18

Nneedle 102, 103NG 35NM 36NRBC 18

OOF 100Offset 35OM 36

PParameter Flags 33PCT 32PDW 31photometer 33Platelet Distribution Width 14Platelet distribution width 31PLT 14, 16, 19, 20, 23, 25, 27, 30, 31, 48, 65, 66, 70, 100Print all settings 67Printer 15, 44, 49, 73, 78, 93Printer setup menu CA620 73

QQC memory 87

RRBC 16, 19, 20, 25, 27, 28, 30, 52, 65, 81RDW 20, 86RDW% 30RDWa 30Reagent 17, 40, 42, 71, 77Red Cell Distribution Width 20, 30Red Cell Distribution Width (Absolute) 13RP 36

106 03-11-24

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

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

UUnits 51

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

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 20E-mail: [email protected], Web: www.boule.se

Documents

User´s Manual - Medonic · PDF fileUser´s Manual Medonic CA620 + MPA + AD Medonic CA620 + MPA Medonic CA620 Medonic CA530 + MPA + AD Medonic CA530 + MPA Medonic CA530 Medonic CA620-CellGuard