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Medonic CA530, User Manual

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Medonic CA530 User Manual Download Page 8

8

03-11-24

1176en01

Name and address of manufacturer:

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

Telephone: +46 8 744 77 00

Fax: +46 8 744 77 20

e-mail: [email protected]

Name and address of distributor

Distributors are listed on:

http.//www.boule.se

Standards

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

Manual number

1504062en

Date of issue

August 2003

Summary of Contents for CA530

Page 1: ...User s Manual Medonic CA620 MPA AD Medonic CA620 MPA Medonic CA620 Medonic CA530 MPA AD Medonic CA530 MPA Medonic CA530 Medonic CA620 CellGuard MPA AD Medonic CA620 CellGuard MPA ...

Page 2: ......

Page 3: ...g Time RBC WBC 28 3 4 WBC Differentials 28 3 5 MCV Mean Cell Volume RBCs 30 3 6 RDW Red Cell Distribution Width 30 3 7 RDWa Red Cell Distribution Width Absolute 30 3 8 HCT Hematocrit 30 3 9 PLT Platelets 30 3 10 MPV Mean Platelet Volume 31 3 11 PDW Platelet distribution width 31 3 12 LPCR Large Platelets 32 3 13 PCT Packed Platelet Volume 32 3 14 HGB Hemoglobin Concentration 32 3 15 MCH Mean Cell ...

Page 4: ...outine Operation 53 7 1 Background Check 53 7 2 Analysing the Sample Open Tube 54 7 3 Analyzing the Sample Pre Dilute 56 7 4 Analysing the Sample Micro Pipette Adapter MPA 57 7 5 Analysing the Sample Cap Piercing Device 58 7 6 Advanced User Options CA620 CellGuard 60 8 User Interface 61 8 1 Sample Memory 61 8 2 Setup Menu 64 8 3 Setup Menu 2 68 9 Warning Displays 75 9 1 Warnings Related to the MPA...

Page 5: ...t Down Transport 95 13 1 Daily Maintenance 95 13 2 Monthly Maintenance 95 13 3 Three 3 Month Maintenance 95 13 4 Short Term Transport 96 13 5 Re packaging and Long Term Transport 96 13 6 Permanent Shut Down and Storing the Instrument 97 13 7 Disposal information 97 14 Trouble Shooting 99 14 1 Counting Time HI TU TL 99 14 2 Counting Time LO 99 14 3 HGB Value Flagged with LO 99 14 4 HGB Value Flagge...

Page 6: ...6 03 11 24 ...

Page 7: ...istrib utor Specimen special conditions of collection and storage conditions General instructions for human blood collection handling storage of samples etc are described in the booklet Hematology for sales and service engineers which is available from your authorized distributor Operator training Additonal operator training is not required under the following conditions 1 The operator must have b...

Page 8: ... Fax 46 8 744 77 20 e mail info bm boule se Name and address of distributor Distributors are listed on http www boule se Standards EN591 2001 IVD 98 79 EG SSEN 61010 2 101 Low Voltage 73 23 EEC EN 61326 1997 with amendment EN 61326 A1 1998 EMC 89 336 EEC Standards harmonized with FDA UL Manual number 1504062en Date of issue August 2003 ...

Page 9: ...k 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 ...

Page 10: ...short circuit If this should occur turn off the power immediately and contact your serv ice department Note The cover should only be opened removed by authorised service personnel Do not touch the electrical circuits inside the cover There is a hazard of electrical shock Note The cover should only be opened removed by authorised service personnel Potentially biohazardous material Because no test m...

Page 11: ...gency Procedure In case of emergency due to an obvious malfunction of the instrument e g smoke or liquid coming out from the inside proceed as follows 1 Switch off the instrument immediately by Pulling out the mains cord from the mains supply 2 Contact your authorized distributor s service department immediately 1 6 Warning Signs in Manual These warning signs in the manual are used to identify pos...

Page 12: ...rd 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 Instrumen...

Page 13: ... 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 ...

Page 14: ...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 540nm Discriminator Floating programmable Sampling system Closed shear valve Parameters reporte...

Page 15: ...ter abnor malities Yes Floating discriminator RBC PLT Yes position printed Mathematical 3 part diff WBC calc Yes Automatic HGB blank on each sample Yes Carry Over 1 Bar code reader input Yes Serial output2 Yes Mains voltage Fuses 230V Fuse 5x20mm T2A 120V Fuse 5x20mm T4A Mains voltage tolerances 15 15 Power consumption max 250 VA Power consumption stand by max 50 VA Frequency 50 60 Hz Built in tes...

Page 16: ... 0 99 9 RBC CA620 Cellguard 0 13 99 RBC CA620 530 0 13 99 MCV 15 250 PLT 0 6999 HGB 0 99 9 PLT Concentrate mode 0 6999 applicable on CA620 Cellguard only Correlation1 1 Using Coulter AcT and Abbot CD1600 as reference RBC WBC R 0 97 PLT R 0 90 HGB R 0 99 MCV R 0 90 Reproducibility typical Measured as an average of 10 measurements each of 10 different vein K2 EDTA collected normal samples Parameter ...

Page 17: ...ing 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 Caution Use only by Boule autho rized reagents Erroneous results and damage of the system ...

Page 18: ...hocyte population Non lyzed RBCs will cause a falsely elevated WBC count See also NRBC above Multiple myeloma The precipitation of proteins in multiple myeloma patients may give elevated WBC counts Hemolyzis Hemolyzed specimen contains red cell stroma debris which may elevate the WBC and or PLT count Leukemias This disease state may result in a spurious low WBC count because of the pos sible incre...

Page 19: ...or this effect with high WBC counts up to WBC approx 60 10e3 µl In case of extreme WBC counts the following is recommended 1 Elevated WBC The diluted sample should be centrifuged and the supernatant fluid checked on a spectrophotometer for turbidity 2 Elevated lipids Elevated lipids in the blood sample will give the plasma a milky appear ance This condition can occur with hyperlipidemia hyperprote...

Page 20: ...sive numbers This may cause a low PLT count since they might fall within the RBC threshold range Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low PLT counts Reference manual methods may be necessary to obtain an accurate platelet count Hemolyzis Hemolyzed specimens contain red cell stroma which may elevate platelet counts A C D blood ...

Page 21: ...otherapy May also effect the size of the PLTs EDTA Note that all samples collected in EDTA will not maintain a stable MPV The PLTs will swell as a function of time and temperature LYMF Lymphocytes The lymphocyte count is derived from the WBC count The presence of nucleat ed red cells NRBC certain parasites and erythrocytes that are resistant to lysis may interfere with LYMF count MID MID sized are...

Page 22: ...ended 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 con...

Page 23: ...530 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 y...

Page 24: ...Specifications 24 03 11 24 1001en01 ...

Page 25: ...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...

Page 26: ...g 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...

Page 27: ...en analyzed by measuring 500 67 5 33 750 cells The reproducibility is directly related to the total number of cells entering the or ifice The higher the concentration the better the reproducibility The instrument has a dilution ratio for RBC of 1 40 000 and the CV will therefore be less than 1 for samples with an RBC number within the normal range 3 2 Sizing RBC WBC and PLT The sizing is done in a...

Page 28: ...re and other secondary effects that might cause pressure changes will NOT influence the counted parameters RBC PLT and WBC 3 4 WBC Differentials Within the 3 part diff technology a general problem is found how to define the correct settings of the discriminators for the lymphocyte MID sized cell mainly Monocytes and Granulocytes areas Many analyzers are using a fixed discrimina tor analogue where ...

Page 29: ...on 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 obviou...

Page 30: ...he 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 c...

Page 31: ...d 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 re...

Page 32: ...r 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 me...

Page 33: ...regular 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 Offse...

Page 34: ...sly 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 ...

Page 35: ...curred 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...

Page 36: ... 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 displaye...

Page 37: ...bilities All anomalies and or abnormal distributions signalled by the instrument should be verified manually for the presence of pathological elements As a result of the differences in stability towards lyzing of cytoplasmic membranes in the different cell types pathological elements can be found in a number of different zones This also applies to the presence of normal or non pathological cells t...

Page 38: ...Parameter Flags 38 03 11 24 1002en01 ...

Page 39: ... 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 Conta...

Page 40: ...ly 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 connection The instrument has an open waste outlet and can be connected to a central waste system within t...

Page 41: ...nstrument installation 1 Lift the instrument and place it on the chosen location as shown below Be careful not to stress the front door of the instrument 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 ...

Page 42: ... 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 Important One valve is located be hind the pre dilute start le ver MPA Do not forget to remove the transport guides in this valve The instrument will not operate correctly in case a transport guide is not...

Page 43: ...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 tif Caution Bio hazard The end of the waste tube must be at a lo...

Page 44: ... instructions as shown in the DPU411 type II DPU414 user manual how to insert paper and how to set the printer on line In case an IBM compatible printer Epson or HP printer is used please refer to Printer and Serial Output on page 93 5 4 Front Panel and Command Keys The front panel of the instrument consists of 1 Numerical keyboard 2 Display 3 Print 4 Menu button 5 Arrow keys 1030 tif 1031 tif 1 4...

Page 45: ...he 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 us...

Page 46: ... 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 ...

Page 47: ...he 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...

Page 48: ...he 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 530 The CA620 530 is configured as default to the most common us...

Page 49: ... 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 Configuration In case a printer is connected to the instrument which ...

Page 50: ...t all parameters in cluding the histograms 10 Scroll to line 4 11 Press Print A list is printed with available pre programmed formats In case a DPU411 type II DPU414 printer is connected recommended only formats can be chosen which are indicated as DPU411 The print format function describes the order of parameters on the printout as well as the font style As default format 8 is set DPU Note If no ...

Page 51: ... 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 Units The instrument has six different unit modes based on SI and CGS units To change choose 1 Select menu 5 10 2 2 Choose the required unit expression from the table bel...

Page 52: ...6 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 LY...

Page 53: ...splay no parameter results Applicable for CA620 CellGuard The operation is identical if the system is programmed for pre donor screening or used as a PLT concentrate control however the displayed number of param eters will be different if used in PLT concentrate mode 7 1 Background Check The following sequence is performed to check that the background is low enough before each series of counts Use...

Page 54: ... 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 Warning Contamination hazard if contaminated blood enters into open cut Always wear protective gloves when handling blood samples Gloves in the picture are not shown fo...

Page 55: ...nt 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 i...

Page 56: ...ample 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...

Page 57: ...ious 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 Warning Contamination hazard if contaminated blood ...

Page 58: ...dle 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 h...

Page 59: ...ed 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 Caution Insert the sample tube with lid facing downwards Ignoring this instruction may damage the aspiration needle 1067 bmp Caution Avoid using the same tube more than twice in the cap piercing device Not doing so might...

Page 60: ...ed 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...

Page 61: ... 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...

Page 62: ...r 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...

Page 63: ... 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 CellGuard We want to check the mean value of all PLT concentrate samples in memory Answer Enter the Sample Memory from the main menu 1 1 Scroll down to line 1 4 and press Enter 2 Scroll to the line From Date and press Enter 3 Scr...

Page 64: ...hin 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 m...

Page 65: ...h the arrow keys to menu 5 6 and press Enter In this menu the floating range for the discriminator also called threshold is set for each PROG It is not advisable to alter the PROGs default settings The de fault is set to values that are strongly recommended Blood mode In the example below PROG 1 is shown by pressing Enter and the settings for the floating discriminator are displayed The displayed ...

Page 66: ... aspiration instead of using the Blood detector Also if PLT H is set to 30 fl instead of 60 fl all PLTs larger than 30 fl will be reported by the system as RBCs which might introduce a slightly false RBC pa rameter value Therefore it is recommended not to change this setting without a compelling reason Set discr WBC Scroll with the arrow keys to menu 5 6 and press Enter In this menu the total rang...

Page 67: ... 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 settings 1 Scroll with the up down arrow key to menu 5 9 2 press Enter The connected printer will list all settings that are user programmable It is...

Page 68: ... 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 bloo...

Page 69: ...the aspiration timer is enabled and the display shows the aspiration time in seconds Serial port setup In case the instrument is connected to an external computer the serial data flow has to be set Scroll to this menu line with the arrow keys and press Enter The following is displayed Change the setting if required by using the left right arrow keys and jump to another line within this menu with t...

Page 70: ...s 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 o...

Page 71: ...ked 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 assigne...

Page 72: ... That the PROG names are not changed in any menu to Blood or PLT C but clarified only as shown above The display and printout however will show Blood or PLT C instead of PROG1 or PROG2 Block parameters The CA620 allows the operator to block certain parameters to be displayed and printed This is especially useful when the instrument is used for PLT concentrate control only Several parameters are of...

Page 73: ...llGuard is used in PLT concen trate mode Printer setup menu CA620 This menu is used for advanced printer options and user definable printout pro gramming 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 pr...

Page 74: ... 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...

Page 75: ...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 ...

Page 76: ...ght be caused by a No sample is entered b An attempt is made to run on distilled water in the pre dilute inlet 9 2 Stand By Mode This warning is displayed after a 45 minutes idle situation The instrument will go to stand by mode after a further 2 minutes The operator may cancel this by pressing Menu If the instrument is in Stand by mode the text displayed might not be clear as the back lighter of ...

Page 77: ... 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...

Page 78: ...ove 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 1124en gif 1125en gif 1126en gif 1127en gif 1127en gif ...

Page 79: ...ng 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 1129en gif 1130en gif 1131en gif ...

Page 80: ...Warning Displays 80 03 11 24 1008en01 ...

Page 81: ...rs is done at the factory with refer ence standard instruments and volumetric measuring methods The metering tube is mechanically constant and will remain stable MCV Calibration of the MCV parameter may be necessary if the temperature environ ment of the laboratory has changed significantly 10 C 10 2 Use of Calibrators and Controls The calibration of the instrument can be verified by counting pre ...

Page 82: ...cedure 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 a...

Page 83: ... Through a Certified Calibrator Recommended calibration periods is twice a year with a Hematology Blood Cal ibrator certified by Boule Good laboratory practice involves regular daily checks with blood controls to as sure the analyzer and reagents are fully functional Calibration procedures are car ried out to minimize any possible drift caused by tolerances in reagents environment changes or instr...

Page 84: ...alibrators 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 re...

Page 85: ...whole blood inlet Secondly run a nor mal sample at the open tube inlet and note down the parameter values then use this sample to calibrate the pre dilute inlet of the instrument Note that the pre dilute inlet is not factory calibrated as the setting is dependent on locally used capillaries and dilution ratio 10 6 Calibration of the MPA The calibration of the Micro Pipette Adapter parameters is si...

Page 86: ...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 withi...

Page 87: ...s 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...

Page 88: ... 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 outsi...

Page 89: ... 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...

Page 90: ...er 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...

Page 91: ... 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 sel...

Page 92: ...QC and Blood Controls 92 03 11 24 1156en01 ...

Page 93: ... 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 Connections The instrument has an output ...

Page 94: ...f 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 connect...

Page 95: ... 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 Maintenance To increase the life time of the tubes in the instrument the following cleaning procedure i...

Page 96: ...ctions below to transport the instrument under secure conditions 13 5 Re packaging and Long Term Transport Whenever the instrument has to be transported over a longer distance or if the system has to be switched off over a period longer than one week it is necessary to follow the instructions below 1 Remove the reagent aspiration tubes from their external container bottle and put them in a bottle ...

Page 97: ...or 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 re...

Page 98: ...Maintenance Shut Down Transport 98 03 11 24 1011en01 ...

Page 99: ...played 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...

Page 100: ... system 2 Electronic failure 3 Mains supply disturbance The most common failure is that condensation has occurred in the instrument due to transport or heavy variations in the laboratory temperature combined with a high humidity environment Let the system warm up for at least 1 hour in Stand by mode 14 6 High Background PLT High PLT backgrounds are usually found at installation only Due to transpo...

Page 101: ... capacity too low 5 Blockage due to large particles in the mixing cup device The following will give the user a first aid in case an Indication number is dis played Indication 1 Date and Time not set Set within the SETUP Menu Indication 2 The Cap Piercing Device was started and immediately aborted by turning the safety cover Counter Clock Wise Press CE and the instrument will be operational Indica...

Page 102: ...eedle 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 ne...

Page 103: ...emove 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 1144en gif 1143en gif Warni...

Page 104: ...nce 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 Warning Pin hazard Always make sure that the instrument is switched...

Page 105: ...ocytes 21 H HCT 19 30 52 Hematocrit 13 19 30 Hemolyzis 18 20 HGB 19 32 35 36 52 54 100 HGB measurement 99 HI 99 100 L Leukemias 18 Levey Jennings Plots 88 List of materials included in delivery 39 List of materials not included in standard delivery 39 LO 99 LPCR 32 Lymphocyte 21 M MCH 32 MCHC 32 MCV 30 81 Mean Cell Hemoglobin 13 Mean Cell Volume 13 30 Mean Platelet Volume 13 21 31 Micro Pipette 14...

Page 106: ...ons 61 62 storage conditions 7 T TB 36 Thrombocytes 20 TL 34 99 TM 36 Transport 95 96 TU 34 99 tubing 102 U Units 51 W Warning flags 15 33 Warranty 9 Waste connection 40 waste container 97 waste liquid 10 43 waste outlet 43 Waste pump 101 Waste tube 39 WBC 18 19 25 27 28 36 66 81 WBC discr Program 71 whole blood 9 ...

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Page 108: ...Article no 1504062 Boule Medical AB P O Box 42056 SE 126 13 Stockholm Sweden Telephone 46 8 744 77 00 Telefax 46 8 744 77 20 E mail mail boule se Web www boule se ...

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