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COULTER STKS Analyzer with Reticulocyte Analysis Reference

1. INTERLOCK SWITCH BEHIND LASER MODULE Figure 6 Triple Transducer Module with Protective Housing 7182030A 4237182A December 1993 23 NOILVHJdO OPERATION PRINCIPLES uniphase a AVOID EXPOSURE Fa lt cc ac Figure 7 Triple Transducer Module without Protective Housing WBC Differential Analysis The STKS makes three measurements volume conductivity and scatter as each cell passes through the flow cell The low frequency impedance measurement defines the volume The high frequency conductivity measurement indicates the internal conductivity The light scatter measurement indicates the structure and shape Three raw analog signals are sent to the Analyzer for amplification signal processing and computation and scatterplot generation of the five differential parameters Parameter values and scatterplot data are sent to the DMS from the Analyzer with the CBC results All results are displayed at the same time 24 PN 4237182A December 1993 Backwash and Rinse PRIMARY OPERATING MODE Backwash of aspiration pathways and rinse functions of Diluter components are performed on the Diluter Approximately 0 5 mL of Erythrolyse II
2. COULTER STKS CALIBRATION FACTORS PARAMETER APERTURE CAL FACTOR WBC AVG WBC AP2 WBC AP3 RBC AVG RBC AP2 RBC AP3 Hgb AVG AVG PIt AVG PIt AP2 PIt AP3 gt MPV AVG an m gt lt gt Date Reagent Lot Numbers Diluent Cleaning Agent CBC Lytic Reagent SCATTER PAK S CAL Calibrator Lot Number Tech Initials SERIAL NO LAB COULTER COULTER CORPORATION 7182024A Miami FL 4237182A December 1993 69 APPENDIX A APPENDIX A 70 PN 4237182A December 1993 REAGENT LOG e3rno APPENDIX A avi VId3S WSZOZELL 901 LN39V3M LOT 3lVd g Q3N3dO CIND G3N3dO 1 QG3N3dO UJaWNNN alva U3aWNNN o poy 31Vq WldX3 101 101 j HO3l HldXd 101 HO3l UldX3 101 datld Ol 1334 Vd d311VOS LNASV ONINVATO IN3OV3M I1LAT 999 SALS 1 09 71 4237182A December 1993 APPENDIX A APPENDIX A 12 4237182A December 1993 ACTION LOG TA NOIL VHOdHOO H3110OO e3rno2 APPENDIX A avi IVIH3S 9202812 N3PIV L NOLLOV 901 NOILOV Q31ON NOILIGNOO
3. Byte of bytes 1 STX 1 byte 2 BLK NBR MS CHAR 1 byte 3 BLK NBR LS CHAR 1 byte 4 DATA BYTES 256 128 C bytes R C 259131 260 132 CRC MSB MS CHAR 1 byte 261 133 CRC MSB LS CHAR 1 byte 262 134 CRC LSB MS CHAR 1 byte 263 135 CRC LSB LS CHAR 1 byte 264 136 ETX 1 byte Presentation Message Structure The data which is blocked for transmission consists of a sequence of ASCII lines each terminated by a CR LF pair The block boundaries for the 256 or 128 byte blocks would have no special significance with respect to this data The data may be thought of as a large ASCII buffer which is being sent 256 or 128 bytes at a time Preamble Field SOH 2 byte CR LF num fields TOT to pp 114 PN 4237182A December 1993 HOST TO DMS COMMUNICATIONS Intro Field 2 byte 2 byte CR LF record type operation For Worklist For Add AD Bach Repeat Field ASCII ASCII CR LF until Tag Data all fields given The 2 byte num fields indicate the number of fields that follow the preamble field that is the intro field plus all data fields The record type indicates the target data set for example WL for Worklist The operation code indicates the action to be performed for example AD for add this record The ASCII Tag is unique to each field within each record type and
4. SENDER DMS RECEIVER HOST SYN ready gt lt SYN go ahead Block Count gt lt ACK ready to receive or NAK receiver abort send data blocks Data gt Block for each block lt ACK block received ok or NAK retransmit block or SYN retransmit all SYN all done gt lt ACK transmission accepted 8 XIaN3ddV Up to 256 blocks of data can be sent The actual number of blocks sent is specified by the two byte ASCII Block Count If the host NAKs a data block the block will be retransmitted It is up to the host to determine how many times it will retry receiving a NAKed block before aborting A SYN sent by the Host at any time other than the initial go ahead forces the DMS to retransmit all data starting with the first block This does not include the initial SYN and block count It is up to the Host to determine under what conditions to transmit a SYN If the spooler enabled option is selected the DMS will continue to send the same message until the Host accepts ACKs each block the message Note To abort a transmission when the spooler is enabled the host must ACK each block of the transmission and discard it locally If the spooler enabled option is not selected the DMS makes only one attempt at transmitting the message 4237182A December 1993 87 APPENDIX B APPENDIX B Data Block Structure Message Structure No Handshake The No Handshake protocol
5. 90 This appendix includes the following log sheets You can photocopy additional copies as needed If your laboratory uses other methods of record keeping disregard them LOG SHEET PAGE Preventive Maintenance and Operational Checks 61 Ramp Pulse Test Results 63 Precision Pulse Test Results 65 Reference Values Ramp and Precision 67 Calibration Factors 69 gt Reagent Log 71 3 Action Log 73 gt lt gt Daily QC Worksheet 75 Graph Point Summary 77 Monthly QC Graphs 79 4237182A December 1993 59 APPENDIX A APPENDIX A 60 PN 4237182A December 1993 PREVENTIVE MAINTENANCE AND OPERATIONAL CHECKS wei NOILVHOdHOO UH3L1NO9 e3rio2 APPENDIX A 020281 avi ON IVIH3S HO31 3una 31VOIQNI Sauni HOV318 AAWA IONl IdNVS aoo a NV310 5991115 uiv NV310 31dNWVS Xv 0076 XVN SVO XVW 100 XVIN OZ O XVIN 0076 XV SVO XVN 100 96H ogy 98H SLION AYVGNOOAS AdVWNIdd Sv 1VNOILVH3dO J3ALLN3A3Hd SYLS d311nOo 61 4237182A December 1993 APPENDIX A APPENDIX A 62 PN 4237182A December 1993 RAMP PULSE TEST RESULTS COULTER STKS RAM
6. Data Length 3 bytes typical Lot Field Tag Sep Data Format lolt Data Length 6 bytes typical 8 XIIN3ddV User Control Name Field Tag Sep Data Format O Data Length 12 bytes typical Expiration Date Field Tag Sep Data Format elxfolalrjel Data Length 8 bytes typical Comments Date output is month day year 4237182A December 1993 1 09 APPENDIX B APPENDIX B Date Field Tag Sep Data Format olalrjel Data Length 8 bytes typical Comments Date output is month day year Time Field Tag Sep Data Format Data Length 8 bytes typical Comments Time output is hours minutes seconds Operator Field Tag Sep Data Format Data Length 3 bytes typical IQAP ID Field Tag Sep Data Format xIxIXI Data Length 12 bytes typical Delete Flag Run was deleted from review screen Field Tag Sep Data Format e e alje Data Length 1 byte typical Note Y means run was deleted Otherwise it is N and will not be transmitted 110 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Shift Field Tag Sep Data Format 3j Data Length 1 byte typical Note Possible are 0 1 2 or 3 See your Operators Guide Control Management by Shift for more detail Cassette Position Field Tag Sep Data Format 5 15 0 5 Data Length 7
7. GRAPHIC PRINTER OPTIONAL DATA MANAGEMENT SYSTEM DMS FRONT REAR NEM Bi BAR CODE EN WAND as 2 FA p HOST i COMPUTER P1 COMMUNICATION ADAPTOR PN 6856995 9V POWER CABLE PRINTER POWER CABLE P2 PRINTER SIGNAL CABLE e PRINTER VARIOUS OPTIONS ANALYZER SIGNALS ANALYZER POWER CABLE PRIMARY POWER oooo CORD POWER x SUPPLY S IN GRAPHIC PRINTER In Y n POWER CABLE AUXILIARY 115 VAC These outlets are independent of the MAIN POWER circuit breaker OUTLETS 74820184 Figure 2 Interunit Power and Signal Cable Connections 14 PN 4237182A December 1993 INTERUNIT CONNECTIONS 8686 AAYASAYd Vd v ASAT Wd H INSTALLATION suonoeuuo aniy Aldd S 43MOd OVA 1599 15 15406 9 1N3SV SNINV319 315 IN3NIIA NANG 13431 OVA 315 13431 lve 9 3SA1XVd AlddNs lt H3MOd p 188 3SA1 H3NV31O 100 31SVM l1HVd IN3NIIA ISdS 5406 Ne NI 13431 NI NI 15
8. Table 24 shows the normal range for Reticulocytes in Absolute numbers x 10 cells L 4237182A December 1993 51 SPECIFICATIONS CHARACTERISTICS Table 24 Subclassification of Data Within the Range Absolute Numbers x 10 cells L Population Population Population Population n Description Minimum Maximum Mean Less than 18 22 99 15 over6t yrs 511 906 7004 19 79 3 Retic Specimen Stability Table 25 shows specimen stability for Reticulocyte percent Table 26 shows it for Reticulocyte number Mean Difference 24 hour result 0 hour result Based on 83 Clinical Specimens Table 25 Specimen Stability Reticulocyte Percent m 2 o FE ul lt iL lt SD of 0 Hour Mean 24 Hour Mean Mean Difference Difference 2 46 1 93 1 76 Table 26 Specimen Stability Reticulocyte Absolute Numbers x 10 cells L 0 Hour Mean 24 Hour Mean Mean SD of Difference Difference 81 67 72 20 30 90 52 PN 4237182A December 1993 PERFORMANCE CHARACTERISTICS Mode to Mode Performance of STKS CBC Differential Table 27 illustrates the Mode to mode comparison accuracy analysis by compared specimens of the CBC parameters based on 50 clinical specimens of whole blood collected KjEDTA Table 27 Mode to Mode Comparison CBC Parameter Mean SD Difference Wc 026 RDW 0 27 Table 28 illustrates the Mode to mode comparison accuracy analysis by compar
9. H UJ Q z H O 92 PN 4237182 December 1993 DMS T0 HOST COMMUNICATIONS The groups and their order of transmission are as follows Test Type Group Number CDR d General Information Group 2 CBC Parameters Group D 3 DIFF Count Parameters Group D 4 DIFF Percent Parameters Group CDR ECD Comments Group CDR 6 Definitive Flags Group CDR Suspect Flags Group CDR 8 Conditional Flags Group CDR Other Flags Group CDR 10 Demographics Group D 1 DF1 Scatterplot Group D 2 DF2 Scatterplot Group D 3 DIFF Histogram Group C 4 RBC Histogram Group 5 PLT Histogram Group R 6 RETICS Parameters Group R DES LS Scatterplot Group R 8 DF6 OP Scatterplot Group R 9 RETICS Histogram Group L 31 DIFF Latex Parameters Group L 32 Retic Latex Parameters Group XYZL 34 Control Information Group XY 35 Control CBC Parameters Group Y 36 Control DIFF Count Parameters Group Y 37 Control DIFF Percent Parameters Group Z 38 Control RETICS Parameters Group Group will not repeat with every test 8 XiaN3ddV Details of Group fields are defined in following sections General Information Group Fields Date Field Tag Sep Data Format olalrjel Data Length 8 bytes typical Comments Date output is month day year Time Field Tag Sep Data Format Data Length 8 bytes typical Comments Time output is hours minutes seconds 42
10. TODS 30 Das Terminal Rey TR From DNS The DMS is the DTE by RS232 standards which explains the RTS DTR pinouts Whether the HOST is a DTE or DCE will determine its use of CTS DSR or RTS DTR A DTE HOST requires the use of a NULL MODEM cable 8 XIaN3ddV Note Pin number 5 CTS must be active for DMS to send any transmissions If the host computer does not support the above hardware handshake lines it will be necessary to connect pin 4 to pin 5 and to connect pin 20 to pin 6 Handshake During a transmission when in full handshake mode the host logically raises CTS to allow the DMS to send data and logically lowers CTS to prevent the DMS from sending data Note If CTS is lowered to hold off the DMS host transmission it must be raised again within the DMS timeout period If CTS is not raised within the timeout period the DMS transmission to the host times out and aborts PN 4237182B March 1995 83 APPENDIX B APPENDIX B DMS sender HOST receiver lt CTS on send me data send data gt send data gt send data gt lt CTS off stop sending data wait process received data lt CTS on send more data send data gt send data gt SUC B 3 COMMUNICATION PARAMETERS Modes The DMS allows a number of communications parameters to be configured by the user These parameters include communications modes as well as parameters enabling the transmission of
11. Figure 10 Laser Warning Label Protective Housing Removed 56 PN 4237182A December 1993 RADIATION HAZARDS LOCATED ON BACK OF UNIT THIS LASER PRODUCT CONFORMS TO THE PROVISIONS OF 21 CFR SUBCHAPTER J SECTION 1040 10 7 B AND 1040 11 Manufactured COULTER COULTER CORPORATION Miami Fla 33196 i B T 2 2 FIT 1 LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED AVOID DIRECT EYE EXPOSURE no POSURE U gt 0 NM gt gt gt oc INTERLOCK SWITCH BEHIND LASER MODULE 7182030A Figure 11 Laser Warning Label Locations Protective Housing On 4237182A December 1993 57 PRECAUTIONS HAZARDS THIS LASER PRODUCT CONFORMS TO THE PROVISIONS OF 21 CFR SUBCHAPTER J SECTION 1040 10 AND 1040 11 Manufactured DATE 19 by COULTER CORPORATION Miami Fla 33196 LOCATED ON BACK OF UNIT 7182031A Figure 12 Analyzer and Diluter o z Q Eo 20 lt lt 58 4237182A December 1993 APPENDIX A LOG SHEETS U
12. Miss Pros FBC x 17 wire E E deus s Maps VHC gal Fas Sw tese Row Bina APPENDIX D Yupa sumo Burns RATS BANGS FOS a 1 Maga Muga porum v Y cca COMMENTS COMMENTS COULTER Patient Report Form COULTER Patient Report Form LAB COPY RECORD COPY NOTE FORM ALIGNMENT FROM COPY TO COPY Chinese blockout obscures codes Bar code label area and MUST BE WITHIN 0 031 INCH OF TOP COPY definition of codes have been removed from these copies 5915 5916 Figure 14 Composite Patient Report Form 140 PN 4237182A December 1993 THE SHADED AREAS INDICATE RESTRICTED AREAS WHICH CANNOT BE ADJUSTED OR CHANGED IN ANY WAY 7515489 B R 6 89 DO NOT BEND OR FOLD COULTER CMS s HEMATOLOGY 2 27 CODE DEFINITIONS FOR RESULTS Results over printable range L Hesullis lower Ihan iab action lirrit Results voted out H Rasultis higher than ab action limit Incomplete computation occurred Result exceeds linearity Review results x Abnormal conditior Abnormal condition caused other S Suspect paramcters to PROFILE wec O rpc O Pot REQDBY DATE PERFORMED BY COULTER Patient Report Form W 5917 Figure
13. SALS YaLINOO 73 4237182A December 1993 APPENDIX A APPENDIX A 74 PN 4237182A December 1993 DAILY QC WORKSHEET COULTER STKS DAILY QC WORKSHEET FOR THE STKS MONTH DAY YEAR SPECIMEN 1 CYCLE NE LY MO 0 LY MO 0 TOTAL U 2 REF 1 SPECIMEN 2 CYCLE NE LY MO EO BA V XIGN4ddV TECH NE LY MO EO BA TOTAL REF 2 GRAPH POINT STKS 1 REF 1 STKS 2 REF 2 2 COULTER COULTER CORPORATION 7182027A Miami FL SERIAL GRAPH POINT 4237182A December 1993 75 APPENDIX A APPENDIX A 76 PN 4237182A December 1993 GRAPH POINT SUMMARY COULTER STKS GRAPH POINT SUMMARY MONTH YEAR 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 V XIGN4ddV EB EACH GRAPH POINT THE MEAN FOR THAT COLUMN THE NUMBER OF GRAPH POINTS 1 STATUS W WITHIN 2 SD S 9 H MORE 2 SD S ABOVE THE L MORE THAN 2 SD S BELOW THE MEAN COULTER COULTER CORPORATION SERIAL NO Miami FL 7182028A 4237182A December 1993 77 APPENDIX A APPENDIX A 78 4237182A December 1993
14. O A 02 N O A 02 PN 4237182B March 1995 131 APPENDIX C APPENDIX C The checksum technique is e data digit value that is the difference between 11 and the Mod 11 sum of the weighted values of the data digits is used as the check digit The start and stop digits are not used as part of the checksum calculation e is made up of 1 start digit 9 data digits and 1 stop digit checksum digit immediately precedes the stop digit WEIGHTED MODULUS 11 DIGIT POSITION 12 11 10 1 Right Justified WEIGHT D 1017 8 4 5 53 6 2 WEIGHT 2 9 The first 9 digits from the right are used for the calculation of the check digit Examples 1 MESSAGE 011529007 USE WEIGHT 1 6359107845362 DIGIT POSITION 7 a ff T weicht 6 3 5 9 10 7 8 4 5 2 Result 0 0 0 0 10 7 40 8 45 0 0 14 0 10 7 40 8 45 0 0 14 124 124 11 11 REMAINDER 3 When the REMAINDER IS 0 0 is the check digit 11 3 8 The value 8 corresponds to character 8 therefore the checksum is 8 and the final decoded message is 0115290078 2 MESSAGE 023229006 USE WEIGHT 1 6359107845362 DIGIT POSITION Right Justified WEIGHT 1 Result EXE Deren 132 PN 4237182B March 1995 CHECKSUM ALGORITHM 0 20 21 16 8 45 0 0 12 122 122 11 11 REMAINDER 1 When the REMAINDER is 1 the calculation must be repeat
15. 4237182A December 1993 INSTALLATION z lt E l lt 16 PN 4237182A December 1993 OPERATION PRINCIPLES 3 3 1 GENERAL This chapter describes the principles by which the STKS counts measures and computes the hematologic parameters 3 2 COULTER METHOD The Coulter method counts and sizes cells by detecting and measuring changes in electrical resistance when a particle in a conductive liquid goes through a small aperture See Figure 4 VACUUM A APERTURE INTERNAL CURRENT ELECTRODE EXTERNAL gt e gt ELECTRODE E S DETAIL OF Q gt BLOOD v SAMPLE CELL APERTURE m 8 BEAKER SUSPENSION 2 APERTURE APERTURE TUBE 7016004A Figure 4 Coulter Method Each cell suspended in a conductive liquid diluent acts as an insulator As each cell goes through the aperture it momentarily increases the resistance of the electrical path between two submerged electrodes one located on each side of the aperture This causes an electrical pulse that can be counted and sized While the number of pulses indicates particle count the size of the electrical pulse is proportional to the cell volume 92 50 In the STKS WBC differential analysis and classification are based on simultaneously measuring the cell volume high frequency conductivity and laser light scatter This yields the volume content and
16. WEG 245 Table 14 shows paired sample analysis using normal blood for 130 paired observations Table 14 Paired Sample Precision WBC Differential Low Mean High Difference Difference m 2 o FE ul lt 21 46 PN 4237182A December 1993 Accuracy PERFORMANCE CHARACTERISTICS Paired Precision of the Reticulocyte Parameters The typical Precision Characteristic for Paired Sample analysis is expressed as the Mean Difference and the Standard Deviation of the Differences for Run 1 and Run 2 Paired Sample Testing was performed using 101 clinical specimens Table 15 shows Difference Analysis of Paired Samples in Percent Table 16 shows Difference Analysis of Paired Samples in absolute numbers expressed in 10 cells L Table 15 Paired Sample Precision Reticulocyte Population Population Population Minimum Maximum Mean B Replicate 2 2 91 Difference A B 0 01 SD of Differences 0 55 Table 16 Paired Sample Precision Reticulocyte Absolute Numbers x 10 cells L Population Population Population Minimum Maximum Mean A Replicate 1 834 8 92 14 B Replicate 2 92 49 Difference A B 0 35 SD of Differences 18 05 79 m gt fe 2 Accuracy of the CBC Differential Parameters x gt D gt O m For CBC parameters aCOULTER S PLUS provided reference data The performance of t
17. 10 10 EEE 9 999 u 9999 E HGB HCT HCT x 10 MCH HGB x 10 MCHC HGB x 10 HCT 0 01 gt D m z gt lt 999 9 g dL 999 9 F ua 99999 PDW 999 9 RET 99 99 RET 100 10 10 ut 9999 Parameter for Investigational Use Only f Calculation formula commonly used in laboratories for these red cell indices t When the internal value is greater than the displayed format the value will be displayed with one less decimal place 4237182A December 1993 1 53 APPENDIX F APPENDIX F Table 36 S l 4 and S I 7 Format Reporting Units Factor Label Format wc J 190 1104 9999 NES 10 999 9 BR a o 999 9 mo 10 999 9 EOS 10 999 9 Ba 19 999 9 NE NE x WBC 100 999 9 LY LY x WBC 100 999 9 MO MO x WBC 100 999 9 EO EO x WBC 100 999 9 BA BA x WBC 100 999 9 sss MCV HCT x 10 RBC 999 9 MCH HGB x 10 99 99 MCHC HGB x 10 HCT 999 9 PW 10 ratio 999 9 RET 10 99 99 RET RET x RBC 100 1 0 101 9999 109 L Parameter for Investigational Use Only For S I 7 format Calculation formula commonly used in laboratories for these red cell indices When the internal value is greater than the displayed format the value will be displayed with one less decimal place wa 154 PN 423718
18. December 1993 HOST TO DMS COMMUNICATIONS Sex Field Tag Data Format Data value Male Female U Unknown O Other Data Length 1 byte maximum Location Field Tag Data Format Data Length 16 bytes maximum Physician Field Tag Data Format Data Length 22 bytes maximum 9 User Field 1 Field Tag Data Format Data Length 16 bytes maximum User Field 2 Field Tag Data Format Data Length 16 bytes maximum 4237182A December 1993 117 APPENDIX B APPENDIX B User Field 3 Field Tag Data Format Data Length 16 bytes maximum Comments 1 Field Tag Data Format Data Length 32 bytes maximum STKS DMS 1G1 SPECIFIC The IG1 switch must be on otherwise this field will be ignored by the Host Worklist Comments 2 Field Tag Data Format Data Length 32 bytes maximum STKS DMS 1G1 SPECIFIC The IG1 switch must be on otherwise this field will be ignored by the Host Worklist Comments Field Tag Data Format Data Length 64 bytes maximum This is a new field introduced in STKS DMS 2A replacing COMMENT 1 and COMMENT 2 Note COMMENT 1 COMMENT 2 For the sake of STKS DMS 1G1 backward compatibility these two items C1 C2 are concatenated and called comment CM ONLY IF the STKS DMS 1G1 backward compatibility switch is set otherwise C1 and or C2 are ignored 118 PN 4237182A December 1993 HOST TO DMS COMMUNICATIONS Pr
19. If you plan to use a power strip other than one recommended by Coulter please call your Coulter Service Representative to be sure that your power strip is compatible with your instrument Supply the STKS from an independent protected circuit A three wire outlet furnishing the applicable line voltage single phase input power is necessary Current carrying capacity of 20 A is recommended although the actual power consumption is only 1650 W The ground path must be capable of carrying the full current of the circuit confirmed thirdwire earth ground The 3 m 10 ft primary power cord on the rear of the Power Supply must be plugged directly into the electrical outlet do not use an extension cord Ambient Temperature and Humidity Air Conditioning Ventilation Install in a room with a temperature of 15 5 to 29 4 C 60 to 85 F Humidity up to 95 without condensation is permissible If the average room ambient temperature changes more than 10 F from the calibrating temperature verify calibration and recalibrate if necessary to ensure conformance to specifications In air conditioned environments an additional 5500 BTU is required to compensate for the heat the system generates All ventilation fans must be at least 25 cm 10 in away from walls or obstructions that could interfere with the flow of air 12 PN 4237182A December 1993 SPECIAL REQUIREMENTS Drainage CAUTION If it is necessary to increase the l
20. Linearity of size measurements MCV and MPV are tested using appropriate techniques Linearity applies only to directly measured parameters gt D gt O m 4237182A December 1993 41 SPECIFICATIONS CHARACTERISTICS Table 7 Linearity Limits CBC Parameter Linearity Range Limits WBC x 10 cells uL 0 to 99 9 0 2 or 3 096 whichever is greater RBC x 10 cells uL 0 to 7 00 0 03 or 1 096 whichever is greater Hgb g dL Primary mode 0 to 18 0 0 2 or 2 096 whichever is greater with typical MCH of 30 pg Primary mode 18 0 to 25 0 Increasing to 496 at 25 0 g dL with a typical MCH of 30 pg Secondary mode 0 to 25 0 0 2 or 2 0 whichever is greater with a typical MCH of 30 pg MCV fL 50 to 200 2 096 Plt x 10 cells uL 0 to 999 10 or 796 whichever is greater MPV fL 5 0 to 20 0 596 Carryover Sample A is a normal blood with WBC of 10 000 1 000 Sample B is diluent The effect of sample A on the values obtained for sample B is less than 2 0096 for WBC Hgb and Plt and less than 1 0096 for RBC This is true when analysis is based on running two blood samples followed by three diluent samples and calculating using the formula lst diluent 3rd diluent x 100 carryover 2nd sample o E 9 E lt lt o e HE lt 9 Lu 72 Operating and Reportable Ranges WBC Differential Operating Range LY MO
21. measured in picograms Calculated by dividing the total hemoglobin by the total number of red cells and multiplying by 10 Calculated automatically by the STKS MCHC Mean cell hemoglobin concentration measured in grams per deciliter Calculated by dividing the total hemoglobin by the hematocrit Also calculated automatically by the STKS MCV Mean cell or corpuscular volume measured in femtoliters and derived from the RBC histogram Manually calculated by dividing the packed cell volume by the red cell count and multiplying by 10 Mean The average value of a set of numbers Refers to a simple arithmetic average or a more complicated statistical estimate N or n The number of samples in a set or batch PN 42371828 March 1995 161 GLOSSARY GLOSSARY Parameters Refers to the easily measurable elements of a blood sample Hematology parameters include white cell count WBC red cell count RBC hemoglobin Hgb hematocrit Hct MCV MCH MCHC red cell distribution width RDW platelet count Plt mean platelet volume MPV the differential parameters reticulocyte Retic or RET Patient Population A large number of patient sample results used to give a fairly consistent average result for each of the red blood cell indices Quality Control A system of checks that provides the laboratory with a way to monitor the reliability of patient results Several techniques are available to assure laboratori
22. specifications are available from Coulter PN 7546856 9 XIIN3ddV 1 Print Contrast Signal PCS 80 min 2 Rellectivity of Media RW 80 min 3 Rellectivity of Ink Rb 16 max 4 spots or voids no ink smearing 5 Edge roughness is included in the bar and space tolerances RW Rb PCS _____ x 100 RW Measurement method is according to American National Standards Institutes MH10 8M 1983 4237182A December 1993 125 APPENDIX C 6 3 PRINTING METHOD Photographic or thermal transfer 6 4 LABEL THICKNESS Maximum label thickness must be such that 1 The tubes outer diameter including the label is not greater than 13 3 mm 2 The label including adhesive 0 006 0 003 in 5 NE WE RATIO Must remain constant over code length C 6 LABEL DIMENSIONS AND DATA The dimensional and data specifications are illustrated in Figure 13 Table 29 explains the specifications called out in Figure 13 APPENDIX C C 7 ACCEPTABLE BAR CODES Within the given specifications the scanner automatically distinguishes the following bar codes Interleaved 2 of 5 Code 39 bar code Codabar NWT7 Code 128 USS 128 Table 30 summarizes the code related specifications 126 PN 4237182A December 1993 ACCEPTABLE BAR CODES LEADING EDGE OF LABEL FIRST BAR LINE SEE SPEC 1 ALL SUBSEQUENT BAR LINES SEE SPEC 2 HUMAN READABLE CODE SEE
23. 15 Ticket Format CUSTOMIZING THE FORM Use ONLY THE UNSHADED areas see Figure 15 for customizing the form to add your name and address or other laboratory information or tests Modify placement of perforations carefully Our standard form contains perforations on the LAB and PATIENT CHART copies Parts 1 and 2 that are 1 1 2 in down from the top of the form This location of the perforation allows you to continue to file a copy similar in length to our previous shorter tickets The form can be customized to place the perforations farther up on the form if you wish however since the ticket is 10 in long your storage system process may need to be altered NO PERFORATIONS ARE ALLOWED ON THE LAST TAG COPY UNLESS THEY ARE PLACED AT LEAST 1 1 2 in DOWN FROM THE TOP gt a m gt lt May print the tickets continuous feed computer paper if all specifications are met Special instructions include Limiting the roughness of the edge of the ticket after tearing the ticket away from the computer form Rough edges cause dust and confetti that might build up around the printer roller causing a jam e Staying within the thickness specification for the total ticket and the limitation on the punch holes Meeting the specifications for the last copy that is must not contain any perforations unless they are at least 1 1 2 in from the top 4237182A December 1993 141 APPE
24. 783 4 Gottmann AW Multiple hematologic analyses by means of a COULTER COUNTER Model S Paper presented at International Symposium of Standardization of Hematological Methods Fondazione Carlo Erbe Milan Italy November 9 and 10 1970 Symposium proceedings published in Haematologica Latina 1969 5 Hamilton PJ and Davison RL The interrelationships and stability of COULTER COUNTER Model S determined blood indices J Clin Path 1973 16 700 705 6 Bessman JD and Johnson Erythrocyte volume distribution in normal and abnormal subjects Blood 1975 46 369 379 7 The diameter of red cells in pernicious anaemia and in anaemia following haemorrhage J Path Bact 1922 25 487 504 8 England JM Walford DM and Waters DAW Reassessment of the reliability of the haematocrit Brit J Haemat 1972 23 247 256 9 Bull BS et al Platelet counts with the COULTER COUNTER Am J Clin Path 1965 44 678 688 10 Mundschenk DD Connelly DP White JG and Brunning RD An improved technique for the electronic measurement of platelet size and shape J Clin Lab Med 1976 88 301 315 11 Schulz and Thom Electrical sizing and counting of platelets in whole blood Med Biol Engr 1973 73 447 454 12 Von Behrens Mediterranean macrothrombocytopenia Blood 1975 46 199 207 13 Paulus JM Platelet size in man Blood 1975 46 321 336 PN 42371828 March 1995 157 REFERENCES 14 International Committee
25. Abnormalities of Cases Criteria Percent Percent Abnormality of Cases Criteria Type Absolute x 10 cells L Count Variant 21 gt 0 70 n a n a Lymphocytes Granulocytosis gt 80 0 Granulopenia lt 10 0 Metamyelocytes gt 2 0 Nucleated RBC MAAR gt 20 Accuracy of Reticulocytes The typical Accuracy characteristic is expressed as the agreement between values given by the COULTER STKS with reticulocyte analysis and results from the NCCLS H16 P Method where n 4000 at any point within the operating range where the Mean Difference and the Standard Deviation of the Differences of compared samples was found to be as follows This was determined by using 101 clinical specimens with values covering the expected range of performance Table 20 shows accuracy difference analysis of compared specimens in percent Table 21 shows accuracy difference analysis of compared specimens in absolute numbers expressed in 10 cells L 29 50 2m 85 m 2 4 ON 40 4237182A December 1993 49 SPECIFICATIONS CHARACTERISTICS Table 20 Accuracy Reticulocyte Population Population Population Minimum Maximum Mean B NCCLS H16 000 19 97 2 47 Difference A B 0 44 SD of Differences 1 20 Table 21 Accuracy Reticulocyte x 10 cells L Population Population Population Minimum Maximum Mean A COULTER STKS 752 9 92 49 B NCCLS H16 629 2 78 30 Difference A B 14 19 S
26. Coulter Principle Pulse height analysis provides a convenient and precise means to classify leukocytes in a way that closely correlates with the conventional categories defined by stained film microscopy 15 16 17 18 sm 22 oo From the outset it had been recognized that the insulating dielectric property of the surface of a particle determines the characteristics of the pulse it generates I you apply high frequency current to the current field the current penetrates the surface of the particle to reveal the internal composition 2021 The angle of the scatter of laser light depends on particle size and refractibility Reticulocytes have been defined as immature nonnucleated erythrocytes that retain a small network of basophilic organelles comprised of RNA and protoporphyrin The enumeration of reticulocytes provides a simple effective means to determine red cell production and regeneration 222 425 The most common means of measuring reticulocytes employs the use of supravital dyes such as New Methylene Blue NMB or Brilliant Cresyl Blue These dyes precipitate and aggregate the basophilic substances within the reticulocyte resulting in a granular staining pattern easily discernable by light microscopy The STKS uses VCS technology for Reticulocyte enumeration in whole blood samples The reticulocytes are stained with NMB and hemoglobin is removed from the RBCs with a clearing agent Simultaneous measur
27. December 1993 DMS T0 HOST COMMUNICATIONS Possible flag values Blasts Imm Grans Bands 1 or 2 Variant Lymphs Review Slide NRBCs Dimorphic RBC Pop Micro RBCs RBC Fragments RBC Agglutination Platelet Clumps Giant Platelets Definitive Flag String Sep Up to 128 Characters Possible values Leukopenia Leukocytosis Neutropenia Neutropenia Neutrophilia Neutrophilia Lymphopenia Lymphopenia Lymphocytosis Lymphocytosis Monocytosis Monocytosis Eosinophilia Eosinophilia Basophilia Basophilia Anemia 1 Anisocytosis 2 Anisocytosis 3 Anisocytosis 1 Microcytosis 2 Microcytosis 3 Microcytosis 1 Macrocytosis 2 Macrocytosis 3 Macrocytosis 8 XIIN3ddV 4237182A December 1993 99 APPENDIX B APPENDIX B 1 Hypochromia 2 Hypochromia 3 Hypochromia 1 Poikilocytosis 2 Poikilocytosis 3 Poikilocytosis Erythrocytosis Pancytopenia Thrombocytopenia Thrombocytosis Small Platelets Large Platelets Other Population Flag ied Up to 128 Characters X Possible flag values Edited data PRELIMINARY REPORT COLLATE FAILED Conditional Flags Up to 24 Characters x Possible flag values Normal WBC Pop Abnormal WBC Pop Normal RBC Pop Abnormal Rbc Pop Normal PLT Pop Abnormal PLT Pop Verify Retic Demographics Group Field This group will be transmitted with the first test only 100 PN
28. Decreased NORMAL MCHC LOW Fa cc ac oa 34 PN 4237182A December 1993 SPECIFICATIONS CHARACTERISTICS 4 f C U 1 4 1 PHYSICAL SPECIFICATIONS Power Input Supply Requirements STKS 90 110 Vac 49 51 Hz and 59 61 Hz 99 121 Vac 49 51 Hz and 59 61 Hz 198 242 Vac 49 51 Hz and 59 61 Hz DMS 90 135 Vac 47 63 Hz or 180 265 Vac 47 63 Hz Consumption 1650 W 5500 BTU h maximum Installation Category per IEC 1010 1 Category II Temperature ambient operating range for patient samples 15 5 to 29 4 C 60 to 85 F Humidity 0 to 95 without condensation Sample Stability 0 to 24 hours based on independent studies Refer to package insert for specific test applications Om 50 2m 59 m 2 o2 40 Recommended Anticoagulant 4237182A December 1993 35 SPECIFICATIONS CHARACTERISTICS Throughput Typical throughput performance is described as average for samples exhibiting parameter levels within the normal range and maximum for samples with elevated parameter levels The table below shows approximate throughput performance data which does not include sample preparation CBC CBC Diff Retics Sample Volume Required Primary mode 250 pL Secondary mode 150 pL Secondary mode with F55 F56 F57 1 5 mL Secondary mode with Retics 2 mL prepared sample Waste 20 liter waste container Pneumatic Supplies In
29. MONTHLY QC GRAPHS COULTER STKS MONTHLY QC GRAPHS 7 2SD 5 4 3 1SD 0 4 1SD 2 3 4 E 5 2505 7 7 LY I 2SD 5 4 3 1SD 2 1 0 4 1SD 2 3 4 2SD 5 6 gt 7 MO 3 oO 2SD gt 1 1SD 0 4 1SD 2SD 3 4 EO 4 3 2SD 2 1 150 4 1SD P 2SD 3 4 BA 4 2SD 3 2 1 150 1 150 E 2SD 3 4 SERIAL NO a COULTER COULTER CORPORATION 7182029A 1 4237182A December 1993 79 APPENDIX A APPENDIX A 80 PN 4237182A December 1993 APPENDIX B TRANSMISSION TO A H0ST COMPUTER 1 DESCRIPTION This Host Transmission Specification STKS Revision 2 adds the following features to the basic STKS CBC Diff parameter transmission Reticulocyte parameters including Date Time e QC Data Worklist IDs with tests ordered as Profiles e Worklist Status Messages e Collated Reports Use this specification if you are planning to send QC data to the Host collate CBC Diff Retic results in the DMS and or planning to transmit results from both STKS and MAXM reticulocyte systems Another option is Part Asp No Read If you set the option f
30. OR FOLD 16 CQULTER CMS H SIS OGY CODE DEFINITIONS FOR RESULTS zan tI Results aver printable range Resultis lower thar iab action lirrit Results votedoul Resultis higherthan lab adtinn mit 4 a Incomplete computatonoccurred Result exceeds lingarity 1 gt Review resurs f Abnormal condition Abnormal concition caused other Suspect 15 i 1 AFFIX BAR CODE HERE 5 l TESTE CBC PROFILE L wec B rec D a tj mor 14 REQ DBY DATE PERFORMED Bv DATE T uh 3 L 6 Tue 15 7 2 f ones Er Menon m ME Mosa ven rm were wr vr Pea 7 Moss 7m FUNT H Prena me w Ris Sus NEUTRO BEN m ib gn x IEA GRAN BASO mnie 85 a m nra n m m I m gs mee pere _ FUS ATS BR 9 12 S COULTER Patient Report Form LAB COPY wigs lt q gl 10 10 4 11 5918 Figure 16 Ticket Specifications SPECIFICATIONS Numbers below refer to corresponding numbers on Figure 16 All dimensions are in inches 10 Nominal dimension from left edge of form to center of first column is 0 248 0 010 throughput length of form to avoid skewness Do not bend or fold the form We suggest a statement to that effect be printed in red on the form S
31. Red and White Counting 26 Coincidence Correction 27 Voting 27 Sweep Flow 27 RBC Size Distribution 28 Plt Count and Size Distribution 29 Plt Fitting Process 29 Derived and Computed CBC Parameters 30 MEASUREMENT OF HEMOGLOBIN CONCENTRATION 30 SCATTERPLOT DEVELOPMENT 30 DF 1 Scatterplot 30 DF 2 Scatterplot 31 DF 3 Scatterplot 31 DF 5 Scatterplot 31 DF 6 Scatterplot 31 X ANALYSIS IN THE DMS 31 Adjusting Initial X Target Values 33 PN 4237182B March 1995 CONTENTS 4 SPECIFICATIONS CHARACTERISTICS 35 4 1 4 2 4 3 PHYSICAL SPECIFICATIONS 35 Power 35 Input Supply Requirements 35 Consumption 35 Temperature ambient operating range for patient samples 35 Humidity 35 Sample Stability 35 Recommended Anticoagulant 35 Throughput 36 Sample Volume Required 36 Waste 36 Pneumatic Supplies Internally Regulated 36 Calibration Stability 36 DMS Storage 37 PERFORMANCE SPECIFICATIONS 37 Precision 37 Replicate Precision CBC 37 Replicate Precision WBC Differential 38 Replicate Precision Reticulocytes 38 Paired Precision Reticulocytes 39 Accuracy 40 Accuracy CBC 40 Accuracy WBC Differential 40 Accuracy Reticulocyte 41 CBC Linearity 41 Carryover 42 Operating and Reportable Ranges 42 WBC Differential Operating Range 42 Reticulocyte Reportable Range 43 Mode to Mode Comparison 43 PERFORMANCE CHARACTERISTICS 44 Precision 44 Replicate Precision of the CBC Par
32. SPEC 3 004540045 005 t 630 370 0 005 0 300 MIN LABEL WIDTH SEE SPEC 9 PLACEMENT INDICATOR SEE SPEC 8 040040030 0040 LI a CODE AREA 0 030 SEE SPEC 6 0 062 gt s 0 250 a E MIN MIN z LEADING QUIET TRAILING QUIET ZONE SEE SPEC 7 ZONE SEE SPEC 4 e LABEL LENGTH lt SEE SPEC 5 gt 2879 Figure 13 Bar Code Label Specifications Table 29 Bar Code Label Specifications Specification Called Out in Explanation Figure 13 1 The first bar of the code B must be parallel to the label edge A within 0 002 2 All subsequent bar lines must be parallel to B within 0 001 3 The human readable code HRC does not include the checksum the dash in the HRC is not encoded in the bar code The trailing quiet zone must be 0 250 minimum The maximum label length is determined by the tube length The scanner can accommodate labels up to 2 35 With HEMOGARD tubes the maximum label length is 2 04 continued 4237182A December 1993 127 APPENDIX C APPENDIX Table 29 Bar Code Label Specifications Specification Called Out in Explanation Figure 13 continued 6 The bar code area contains the start character data digits checksum and stop character The leading quiet zone must be 0 250 minimum The placement indicator shows you which end of the label goes next to the tube stopper This is an optional feature not a mandatory one 9 The width of the label mu
33. during the first two minutes after power on note them and call your Coulter Service Representative J XIANJddY 4237182A December 1993 147 APPENDIX E APPENDIX E 148 PN 4237182A December 1993 APPENDIX F REPORTING UNITS Table 31 US 1 Format Reporting Units Parameter Unit Label Display Format NE 677 999 9 LY Ww 999 9 MO 999 9 EO GE 999 9 BA 999 9 NE NE x WBC 100 999 9 LY LY x WBC 100 999 9 MO MO x WBC 100 999 9 EO EO x WBC 100 999 9 BA BA x WBC 100 999 9 pou REC to 9999 HGB gd 9999 999 9 x 10 999 9 MCH HGBx10 RBC pg 9999 MCHC HGB x 10 999 9 RDW pl 999 9 PCT 9 999 PDW ratio 999 9 RET GE 99 99 RET RET x RBC 100 9999 Parameter for Investigational Use Only f Calculation formula commonly used in laboratories for these red cell indices t When the internal value is greater than the displayed format the value will be displayed with one less decimal place gt D m gt lt 4237182A December 1993 149 APPENDIX F APPENDIX F Parameter WBC NE LY MO EO BA NE LY MO EO BA RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW RET RET Table 32 US 2 Format Reporting Units mals Factor Label Ey M o W g
34. graphic data Time Out The time out value determines the amount of time the DMS will wait for a response from the host before retrying to send data to the host If the spooler is enabled the DMS will continue to transmit at the time out intervals until the host successfully receives the data If the spooler is not enabled the message will be aborted when the next available message is ready to be transmitted The time out value can be 1 to 30 seconds The default value is 9 seconds Baud Rate The following baud rates are supported 110 300 1200 2400 4800 9600 19200 For nongraphic transmissions the recommended baud rate is 22400 For graphic transmissions the recommended baud rate is 29600 84 PN 4237182A December 1993 COMMUNICATION PARAMETERS Data Bits The DMS Host communications only supports the 8 bit Data Bit mode Note For Host systems that only support 7 bit data the DMS should be configured for No Parity and the Host should be configured for Marked Parity Parity Odd Even and No parity modes are supported Odd parity is the default value Stop Bits Choose 1 or 2 Default is 2 Block Size The DMS Host Communications support block sizes of 128 and 256 bytes Default is 256 bytes 8 XIaN3ddV Spooler Enable When enabled each host transmission is spooled and kept on the spool until the Host acknowledges the transmission was successfully copied To transmit graphics to the Host the spoo
35. histograms CAUTION The computer installed with your instrument is an integral part of the system It may not be used to operate personal software that has not been authorized for use by Coulter The computer may only be used with software that is authorized by Coulter Introduction of non authorized software may compromise system integrity and cause operational failures The DMS is not for use as a general purpose personal computer 6 PN 4237182A December 1993 Reagent Subsystem SYSTEM FUNCTION Except for the reagents used off line to prepare Retic samples the required reagents are introduced into the system via tubing The reagents are drawn from their individual external containers and dispensed automatically in measured amounts during the operating cycle Coulter recommends the following reagents or their equivalents for use with the STKS Refer to the containers label for detailed information before using the reagent mc co sm 12 oo Diluent ISOTON III diluent is an azide free isotonic electrolyte that dilutes the blood sample stabilizes the cell membranes for accurate counting and sizing and conducts aperture current Diluent also carries and focuses the sample stream in the flow cell of the Triple Transducer Module to direct the white blood cells individually through the aperture CBC Lytic Reagent LYSE S III diff lytic reagent is an azide free lytic reagent that rapidly lyses erythrocytes fre
36. might include further measurements of cell size and platelet distribution biochemical investigations manual WBC differential or any other definitive test that helps diagnose the discrepancy 1 2 METHOD HISTORY The STKS derives three groups of parameters CBC WBC differential and Reticulocytes referred to in these manuals as Retics The methods used to derive the CBC parameters are refinements of the well established Coulter method of counting and sizing in combination with an automatic diluting and mixing device for sample processing and single beam photometer for hemoglobinometry W H Coulter describes the principle The instrument employs a non optical scanning system providing a counting rate in excess of 6 000 individual cells per second with a counting interval of 15 seconds A suspension of blood cells is passed thru a small orifice simultaneously with an electric current The individual blood cells passing thru the orifice introduce an impedance change in the orifice determined by the size of the cell The system counts the individual cells and provides cell size distribution The number of cells counted per sample is approximately 100 times greater than the usual microscope count to reduce the statistical error by a factor of approximately 10 times This substantial improvement in precision over previous methods helped to establish the erythrocyte count as a sensitive index of erythropoietic dyscrasia particularly whe
37. on the Diluter keypad The cycle begins Transport The right lift platform Figure 5 beneath the stacked cassettes rises and the bottom cassette is deposited on the transport The platform lowers the cassette to the level of the rocker bed The cassette is then moved onto the rocker bed where it is rocked back and forth mixing the samples The cassette continues to move toward the sensing station until it reaches the tube sensor When the first tube is sensed the stripper plate locks onto the tube After at least 14 rocks from the time the cassette was loaded the rocker bed locks in a 45 forward position At the sampling station the tube is locked in position and the piercing needle rotates upward The tube ram pushes the tube out from the cassette causing the needle to pierce the tube stopper The bar code 18 PN 4237182A December 1993 PRIMARY OPERATING MODE reader scans the cassette and tube labels on both its forward and return passes an audible indicator can be enabled to indicate each correctly read bar code If the bar code reader detects a discrepancy between the two readings it makes an additional pass If there is a no read situation positive identification is not achieved Aspiration After the cap is pierced a pump draws 250 pL of sample through the needle into the Blood Sampling Valve BSV The blood detector monitors the passage of sample through the BSV and aspiration lines The tube ram is withdrawn and th
38. representing cells 36 fL and greater volume calibration referenced to latex particles in ISOTON III diluent are classified as red cells and pulses from the WBC bath representing 26 PN 4237182A December 1993 COUNTING AND SIZING cells greater than 35 fL volume calibration referenced to latex particles in ISOTON III diluent are classified as white cells The RBC and WBC counts are sent to the Analyzer computer for coincidence correction and voting The final counts are sent to the DMS where they are displayed then to the optional Printer for hard copy reporting Coincidence Correction Occasionally more than one cell may be within the boundaries of an aperture at the same time When this occurs only one pulse is counted However the frequency of coincidence is a statistically predictable function of cell concentration Coincidence correction is done by the Analyzer computer Voting To prevent data errors due to statistical outliers or obstructions that may block an aperture the Analyzer votes on the data from the apertures and rejects any questionable data For the WBC count RBC count MCvV RDW Plt count and MPV the Analyzer computer compares the data from the three apertures to verify that at least two apertures have produced data within an established statistical range of each other If the data from one aperture is outside the established statistical range the data and histograms from that aperture are voted out The a
39. retained in the Analyzer This result is sent to the DMS at the end of the cycle The test results and histograms are displayed at the DMS and a printout is generated Differential Multiparameter Sensing System For the WBC differential the multiparameter sensing system produces the three measurement signals Figure 6 shows the Triple Transducer Module and its protective housing as it resides in the Diluter Tamper proof screws secure the protective housing they can only be removed with a special tool WARNING Do not attempt to remove the laser from the Diluter module The laser is a helium neon laser that complies with the United States performance standard for laser products Title 21 Code of Federal Regulations 1040 10 Figure 7 shows the laser module without its protective housing to display the flow cell and label locations Fa lt cc ac 22 PN 4237182A December 1993 LOCATED ON BACK OF UNIT THIS LASER PRODUCT CONFORMS TO THE PROVISIONS OF 21 CFR SUBCHAPTER J SECTION 1040 10 AND 1040 11 PRIMARY OPERATING MODE Z Manufactured DATE 19 by COULTER CORPORATION Miami Fla 33196 00000000 COULTER 51 5 LASER RADIATION WHEN OPEN AND INTERLOCK DEFEATED AVOID DIRECT EYE EXPOSURE
40. transmissions Each TEST TYPE defined in the following sections is identified by the order in which it appears after the preamble The test types will never be transmitted out of order The test types are up to 32 characters long Available tests controls are as follows 1 CBC CBC test 2 DIFF DIFF test 3 RETIC RETICS test 4 5 5 Control 5 4CC 4C Control 6 RETICC Retic Control 7 LATEXC Latex Control 4237182A December 1993 89 APPENDIX B APPENDIX B Test Identification T TEST L GROUP C L TYPE R F COUNT F The ASCII character T marks the beginning of a test identification TEST TYPE see transmission identification GROUP COUNT defines the number of groups of data in this particular test type Group G GROUP C L FIELD C L FIELD C L FIELD C L NUMBER F COUNT R F 1 R F N The ASCII character G marks the beginning of the group GROUP NUMBER defines the group number See Group definitions FIELD COUNT defines the number of fields in a particular group See Field Count FIELD defines a field within a group See Fields Note When there are no data for a Group the Group will not be sent Test Type Count The transmission identification section has a test type count that identifies the number of tests contained within the transmission Valid test type count can be from 0 255 The test type count uses two characters to give the ASCII r
41. 1 33 NCCLS H 20A vol 12 No 1 34 VCS Technology Monocyte Counting on COULTER STKS and COULTER MAXM Monograph Coulter Corporation 35 Miale JB Laboratory Medicine Hematology 3rd Edition 1967 CV Mosby pages 592 595 PN 4237182B March 1995 1 59 REFERENCES 160 PN 4237182B March 1995 GLOSSARY U Batch A group or set of results For X Analysis batch consists of 20 patient samples Batch Mean The mean or average of a set of samples For X Analysis the batch mean is a value based on a statistical averaging technique and is a type of weighted moving average It is used to estimate what simple average result of a very large number of samples population mean might be by using a small number of samples Current Batch The number of samples currently being collected The samples are listed line by line in a table called Current XB Batch under XB in the Sample Analysis option on the DMS Data Management System DMS The computer attached to the STKS instrument It automatically stores patient results and performs X Analysis as one of its functions Indices Term that refers to the three red cell erythrocyte parameters which reflect the size and hemoglobin content of the red cells The three indices are mean cell volume MCV mean cell hemoglobin MCH and the mean cell hemoglobin concentration MCHC ce gt lt MCH Mean cell hemoglobin
42. 16 algorithm The polynomial for this algorithm is 16 12 X 5 1 Note D current data byte that is input to the algorithm CRCLSB CRCMSB data byte Least significant and most significant CRC accumulator bytes x gt gt n means x is shifted n bits to right or is the same as x divided by 2 x n means x is shifted n bits to left or is the same as x multiplied by 2 at beginning CRCLSB OFFH octal 377 decimal 255 CRCMSB OFFH octal 377 decimal 255 4237182A December 1993 121 APPENDIX B then for each data byte in a block X D XOR CRCMSB X XXOR X gt gt 4 CRCMSB CRCLSB XOR X gt gt 3 XOR X lt lt 4 CRCLSB XXOR X 5 and at end CRCLSB CRCLSB XOR OFFH CRCMSB CRCMSB XOR OFFH APPENDIX B 122 PN 4237182A December 1993 CRC CRC Example Written in ASM86 The following is an example of CRC16 code written in assembler for 8086 GET_CRC_BYTES PROC PUSH CX This is the Algorithm used CCITT CRC16 X D XOR CRCMSB X X XOR X gt gt 4 CRCMSB CRCLSB XOR CRCLSB X XOR X lt lt X gt gt 3 X lt lt 4 3 Data arrives in AL Finished CRC is in BX BH MSB BL LSB To use this algorithm 1 Initialize BX to OFFFFH 2 At end CRCLSB CRCLSB XOR OFFH CRCMSB CRCMSB XOR OFFH XOR AL BH X D XOR CRCMSB AL X 1 MOV AH AL Save X for later in AH gt SHR 4 Then AL X gt
43. 2 Size 142 Paper 142 Copies 142 Adhesive Strip Optional 142 Ticket Areas 143 APPENDIX E BAR CODE WAND 145 E l DESCRIPTION 145 E2 HOW TO SCAN A BAR CODE 146 E 3 INSTALL THE WAND 146 APPENDIX F REPORTING UNITS 149 REFERENCES 157 GLOSSARY 161 INDEX 163 ILLUSTRATIONS 1 COULTER STKS 1 2 Interunit Power and Signal Cable Connections 14 3 Pneumatic Hydraulic Connections 15 4 Coulter Method 17 vi PN 4237182B March 1995 m 17 18 19 20 21 22 23 24 25 CONTENTS Transport System and Triple Transducer Location 20 Triple Transducer Module with Protective Housing 23 Triple Transducer Module without Protective Housing 24 Sweep Flow 28 The X Formula 32 Laser Warning Label Protective Housing Removed 56 Laser Warning Label Locations Protective Housing On 57 Analyzer and Diluter 58 Bar Code Label Specifications 127 Composite Patient Report Form 140 Ticket Format 141 Ticket Specifications 143 TABLES Effect of Directly Measured Parameters on the Red Cell Indices 34 Replicate Precision CBC Parameters n gt 31 38 Replicate Precision WBC Differential Parameters 38 Replicate Precision Reticulocyte 39 Accuracy Tolerance Limits WBC Differential 40 WBC Differential Bias 40 Linearity Limits CBC 42 Reticulocyte Reportable Range 43 Replicate Precision CBC 44 Replicate Precision WBC Differential 45 Replicate Precision Reticulocyte
44. 20H or HT 09H characters The data portion of a field will only contain ASCII characters in the range of 20H to 7EH Heading B 6 tabulates the valid ASCII characters Fields are separated with a CR and a LF OAH character All fields are a maximum of 32 characters unless otherwise noted The following abbreviations are used to describe the fields SEP one or more SP 20H or HT 09H characters The syntax for the Data Format of a field is A Alpha characters a z and A Z and space or 61H 7AH and 41H 5AH and 20H N Numeric characters 0 9 and or 30H 39H and 2BH 2DH 2EH 4237 182 December 1993 91 APPENDIX B APPENDIX B X Printable characters 20H 7EH Hexadecimal characters 0 9 and A F O Other characters CR and LF or ODH and OAH Note A fields position within a Group must not be used to identify it Fields within a Group may appear in any order or may be omitted The CR LF should be used to find fields and the Tag used to identify it Postamble The postamble marks the end of the current message There are 38 groups defined in the current implementation of the DMS Future revisions of DMS may include additional groups Any future additions will not disrupt the order of the groups as presently defined Group Definition The abbreviations listed below describe the following table ETIC CONTROL ATEX CONTROL EG NHP2UUO
45. 2B March 1995 REPORTING UNITS Table 37 Japan Format Reporting Units Factor Label Format MO 1 999 9 NE NE x WBC 100 99999 LY mo x WBC 100 MO MO x WBC 100 99999 EO 0 x WBC 100 99999 10 10 10 E Es 10 10 10 10 10 10 10 10 10 BA 100 10 10 99999 E 100 10 E UE 10 ETN 10 10 EE HGB g dL 999 9 HCT 999 9 BEE REC 10 99999 ZZ IG E MCV fL 9999 od gt D m z gt lt des x DE 999 9 MCHC HGB x 10 HCT g dL 999 9 RDW 999 9 pertes xw RET RET x RBC 100 99 99t ratio Parameter for Investigational Use Only Calculation formula commonly used in laboratories for these red cell indices t When the internal value is greater than the displayed format the value will be displayed with one less decimal place 4237182A December 1993 1 55 APPENDIX F APPENDIX F 156 PN 4237182A December 1993 REFERENCES U C Y YY 1 Coulter WH High speed automatic blood cell counter and cell size analyzer Paper presented at National Electronics Conference Chicago IL 1956 October 3 2 GM Schneiderman M and Williams GZ Evaluation of electronic red blood cell counter Am J Clin Path 1956 26 1439 1449 3 Brittin GM Grecher G and Johnson CA Evaluation of the COULTER COUNTER Model S Am J Clin Path 1969 52 780
46. 37182A December 1993 93 APPENDIX B APPENDIX B ID 1 Field Tag Sep Data Format Data Length 16 bytes typical Preassigned ID 1 Field Tag Sep Data Format fois Data Length 16 bytes typical Cassette Position Field Tag Sep Data Format 515 0 5 Data Length 7 bytes typical Comments CASSPOS output is cassette number cassette position Data Values Secondary P Primary Preassigned Cassette Position Field Tag Sep Data Format elefalsIs rlols Data Length 6 bytes typical Comments PCASSPOS output is cassette number cassette position The sample mode is unknown ID 1 Status Field Tag Sep Data Format Data values P positive id edited id Data Length 1 byte typical 94 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Cassette Position Status Field Tag Sep Data Format ie ejs r A v v s Data values P positive id edited id Data Length 1 byte typical Sample Status Tag Sep Data Format slalsIrJalrjuls Data values PART ASP partial aspiration NO READ barcode not read MATCH match not found in Worklist MISMATCH non positive ID did not match Data Length 8 bytes typical 8 XiaN3ddV Note There may be others such as Preliminary Report CBC Parameter Group Fields Each field in the CBC Pa
47. 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Date of Birth Field Tag Sep Data Format e r e In Birth field is month day year Data Length 10 bytes typical User Field 1 Tag Sep Data Format Data Length 16 bytes typical User Field 2 Tag Sep Data Format lel xixixixixixIxixIxIxIxIx x xIx x Data Length 16 bytes typical 8 XiaN3ddV User Field 3 Tag Sep Data Format bebe pfx x xf fx x fp xx x x xx Data Length 16 bytes typical Sex Field Tag Sep Data Format Space Al Data Length 1 byte typical Data value Male F Female U Unknown O Other 4237182A December 1993 101 APPENDIX B APPENDIX B Location Field Tag Sep Data Format ic o e a r i olv Data Length 16 bytes typical Physician Field Tag Sep Data Format Data Length 22 bytes typical User Entry Date Field Tag Sep Data Format m Data Length 8 bytes typical User Entry Time Field Tag Sep Data Format Data Length 5 bytes typical ID 2 Field Tag Sep Data Format H Data Length 16 bytes typical Sequence Number Tag Sep Data Format 5 Data Length 6 bytes typical 102 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Profile Field Tag
48. 45 Replicate Precision Reticulocyte in 10 cells L 45 Paired Sample Precision CBC 46 Paired Sample Precision WBC Differential 46 Paired Sample Precision Reticulocyte 47 Paired Sample Precision Reticulocyte Absolute Numbers x 10 cells L 47 Accuracy CBC 48 Accuracy WBC Differential 48 Abnormalities 49 Accuracy Reticulocyte 50 Accuracy Reticulocyte x 10 cells L 50 Reference Range WBC Differential 50 Subclassification of Data within the Range Reticulocyte Percent 51 Subclassification of Data Within the Range Absolute Numbers x 10 cells L 52 Specimen Stability Reticulocyte Percent 52 PN 4237182B March 1995 vii CONTENTS 26 Specimen Stability Reticulocyte Absolute Numbers x 10 cells L 52 27 Mode to Mode Comparison CBC 53 28 Mode to Mode Comparison Diff 53 29 Bar Code Label Specifications 127 30 Code Related Specifications 128 31 105 1 Format Reporting Units 149 32 105 2 Format Reporting Units 150 33 S land 51 5 Format Reporting Units 151 34 51 2 S I 6 Format Reporting Units 152 35 S L3 Format Reporting Units 153 36 51 4 S I 7 Format Reporting Units 154 37 Japan Format Reporting Units 155 VIII PN 4237182B March 1995 USE AND FUNCTION 1 1 1 INTENDED USE The COULTER STKS Figure 1 is a quantitative automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratorie
49. 993 CHECKSUM ALGORITHM VALUE CODE A CODE B CODE C 65 SOH 6 66 STX b 6 70 ACK 70 71 BEL w 7 83 DC3 s 84 DC4 84 87 ETB 87 88 CAN 88 gt m gt lt zl 4237 182 December 1993 137 APPENDIX C APPENDIX C VALUE CODE A CODE B CODE C 91 92 93 94 95 96 97 98 99 100 101 102 103 104 105 SHIFT SHIFT CODE C CODE C 91 92 93 94 CODE B FNC 4 CODE B FNC 4 CODE A CODE A FNC 1 FNC 1 START CODE A START CODE B START CODE C FNC 1 138 PN 4237182A December 1993 APPENDIX D AUTO REPORTER 3 TICKET SPECIFICATIONS U 0 1 GENERAL INFORMATION The layout in Figure 14 illustrates the three parts of the Standard Patient Report Form available through CMS 275 277 Coulter PN 7546921 Note that this form 1 Allows the printout of all STKS parameters and flags these Suspect and Definitive messages Suspect Definitive Definitive Blasts Lymphopenia Hypochromia Imm Grans Bands 1 Lymphocytosis Poikilocytosis Imm Grans Bands 2 Neutropenia Small Platelets Variant Lymphs Neutrophilia Large Platelets NRBCs Monocytosis Micro RBCs Eosinophilia RBC Fragments Basophilia RBC Agglutination Anisocytosis gt Platelet Clumps Microcytosis 9 Giant Platelets Macrocytosis gt lt 2 Provides spaces for Pct PDW In the DMS SET UP screen you can set these parameters to ENABLED or DISABLED When set to DISABLED results
50. C Histogram Field Tag Sep Data Format CREER sa Data Length 512 bytes typical PLT Histogram Group Fields PLT Histogram Field Tag Sep Data Format VE P 4 Data Length 256 bytes typical 8 XIIN3ddV PLT Fit Histogram Field Tag Sep Data Format Fc i aii Data Length 512 bytes typical DFS LS Scatterplot Group LLS X1 Valley Tag Sep Data Format L Data Length 3 bytes typical 4237182A December 1993 1 05 APPENDIX B APPENDIX B LLS X2 Valley Tag Sep Data Format L Data Length 3 bytes typical DC Valley Tag Sep Data Format Data Length 3 bytes typical LLS Valley Tag Sep Data Format E Data Length 3 bytes typical DF 5 LS Scatterplot Field Tag Sep Data Format ee Data Length 4096 bytes typical The LS Scatterplot Data is transmitted as a 4096 byte ASCII array DF 6 OP Scatterplot Group OP 3 Valley Tag Sep Data Format 12 LI NININ Data Length 3 bytes typical 106 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS DC Valley Tag Sep Data Format ele LJ Data Length 3 bytes typical DF 6 OP Scatterplot Field Tag Sep Data Format Data Length 4096 bytes typical The OP Scatterplot Data is transmitted as a 4096 byte ASCII array RETICS Histogram Group Fields V Histogram Field Tag Sep Data Format Data Length 512 bytes typica
51. COULTER STKS Analyzer with Reticulocyte Analysis Reference Z lt uu E rJ 4 pa PN 4237182B March 1995 COULTER CORPORATION Miami Florida 33196 READ ALL PRODUCT MANUALS AND CONSULT WITH COULTER TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS CAUTIONS and IMPORTANTS alert you as follows WARNING Might cause injury CAUTION Might cause damage to the instrument IMPORTANT Might cause misleading results CAUTION System integrity might be compromised and operational errors might occur if Thisequipment is used in a manner other than specified Operate the instrument as instructed in the Product Manuals You introduced software that is not authorized by Coulter into your computer Only operate your system s computer with software authorized by Coulter Coulter Corporation urges its customers to comply with all national health and safety standards such as the use of barrier protection This may include but it is not limited to protective eye wear gloves and suitable laboratory attire when operating or maintaining th
52. D of Differences 35 19 Reference Ranges WBC Differential Reference Range Table 22 shows the reference range of normal values for 160 subjects Table 22 Reference Range WBC Differential Low High Cell Type Lower Upper Absolute Absolute Neutrophil 4 90 Eosinophil 010 450 0 30 o 9 E lt oc lt o e HE lt 9 Lu 72 50 4237182A December 1993 PERFORMANCE CHARACTERISTICS Retic Reference Range The reference interval for the STKS with reticulocyte analysis was derived using donor specimens where the donor based on a questionnaire was not suffering from a hemorrhagic disorder and was not currently bleeding The database was divided into groups based on age race and sex The upper and lower tails of each distribution of test values were deleted The resulting minimum and maximum values of the normal variate continuum were reported as the lower and upper reference intervals by sex race and age Table 23 shows the 95 subclassification of data within the range for reticulocyte percent Normal Reference Interval Reticulocyte 0 66 to 2 85 at 95 confidence Reticulocyte 27 9 to 121 6 at 95 confidence Table 23 Subclassification of Data within the Range Reticulocyte Percent Description Limit Limit Mean Deviation 79 m gt fe 2 x gt D gt O m
53. DF 2 displays WBC volume on the y axis and conductivity on the x axis This display shows the lymphocyte monocyte and granulocyte populations The granulocyte population includes the neutrophils basophils and eosinophils DF 3 displays the same data as DF 2 with the eosinophil and primary neutrophil populations gated out Basophil lymphocyte and monocyte cell populations are easier to see with this display 79 n 23 md m oO 2 DF 5 is a two dimensional scatterplot which shows mature red cells reticulocytes Cell volume is plotted on the y axis and laser light scatter characteristics are plotted on the x axis DF 6 is a discriminant function derived primarily from reticulocyte conductivity DF 6 displays Retic volume on the y axis and conductivity on the x axis 3 8 X ANALYSIS IN THE DMS Studies Bull 1974 Koepke 1981 indicate that the red cell indices MCV MCH and MCHO o patient populations are stable over time This stability characteristic of the indices is the basis of a quality control technique called X Analysis In a manually implemented system population means target values are established by analyzing as large a sample as possible at least 250 but ideally 1000 blood samples The X Analysis used in the DMS does all the calculating automatically 4237182A December 1993 31 OPERATION PRINCIPLES Once the target values have been established the X Analysis can be applied usin
54. E Use the wand to scan the bar cod fields on the 5C cell control assay sheet l Gotoa CBC DIFF Control Set Up screen 2 Hold the wand like a pencil The wand works best when tilted from 10 to 30 from vertical but works at any angle from 0 to 45 3 Place the tip of the wand on the white space on either side of the bar code to be scanned 4 Draw the wand smoothly and lightly across the bar code from one end to the other without lifting the tip of the wand 5 The system beeps to indicate a successful scan and the information from the assay sheet now appears on the DMS screen If the system does not beep scan the label again If there are no positive results after three tries a Check the cable connections then retry b Power the DMS off and on then retry c Call your Coulter Service Representative E 3 INSTALL THE WAND The wand comes in a kit Coulter PN 6912949 for the 115 Vac version l Carefully unpack the wand and the interface power supply 2 Turn off the DMS 3 Onthe back of the DMS locate the communication port P4 If the raw data collection cable is connected to P4 you must remove it 4 Connect the 25 pin connector side of the interface assembly to port P4 5 Connect the wands 9 pin connector to the reciprocal 9 pin connector on the interface box 146 PN 4237182A December 1993 INSTALL THE WAND 6 Plug the wand into a 115 Vac outlet 7 Turn on the DMS If any error messages occur
55. KS with Reticulocyte Analysis are given in Table 9 Table 9 Replicate Precision CBC Parameter WAC aow Replicate Precision of the WBC Differential Parameters o E 9 E lt lt o e HE lt 9 Lu 72 Table 10 shows precision by replication 31 times with single specimen 44 PN 4237182B March 1995 PERFORMANCE CHARACTERISTICS Table 10 Replicate Precision WBC Differential iid dad d Recovery Deviations Replicate Precision of the Reticulocyte Parameters The typical Precision Characteristic is expressed in terms of Coefficient of Variation CV This was determined by simple replicate testing with a representative donor specimen sampled using 31 separate dilutions For studies of whole blood specimens collected in KEDTA Table 11 shows precision for Retic and Table 12 shows precision for Retic Table 11 Replicate Precision Reticulocyte 96 nz31 Mean 17 91 Table 12 Replicate Precision Reticulocyte in 10 cells L nz31 Level III Mean 805 94 oa 29 50 2m 85 m 2 o2 no 4237182A December 1993 45 SPECIFICATIONS CHARACTERISTICS Paired Precision of the CBC Differential Parameters The results of paired difference analysis for 226 paired clinical blood specimens are given in Table 13 Table 13 Paired Sample Precision CBC Population Mean Parameter Low on Difference SD of Difference
56. L Your instrument is tested before it is shipped from the factory International symbols and special handling instructions are printed on the shipping cartons to inform the carrier of the precautions and care applicable to electronic instruments CAUTION Do NOT uncrate the STKS your Coulter Representative is responsible for uncrating installing and initially setting it up 2 mi 2 gt a 2 When you receive your instrument carefully inspect all cartons If you see signs of mishandling or damage file a claim with the carrier immediately If the shipment was separately insured file a claim with the insurance company 2 2 SPECIAL REQUIREMENTS Install and operate this instrument in a conventional clinical laboratory environment Since the individual units are all interrelated you must determine the overall layout before your Coulter Representative arrives to install the instrument Consider the following special requirements Space and Accessibility In addition to the space required for the individual components consider the following Comlortable working height e Access to the rear of the individual units is required for servicing Allow at least 46 cm 18 in for the rear doors plus sufficient room for work space Units may be moved to obtain additional work space 4237182A December 1993 11 lt E l lt Z INSTALLATION Electrical Input CAUTION
57. NDIX D APPENDIX D D 3 SPECIFICATIONS The shaded areas shown in Figure 15 indicate restricted areas that cannot be adjusted or changed in any way Size Length 8 97 in to 10 019 in Width 3 23 in to 3 25 in Paper Copies The first copy must be self contained since the printer has no ribbon and must have a smoothness minimum of 200 using the Sheffield Device or equivalent Last copy should be 125 Ib manila tag for optimum feeding through the printer Form thickness 0 013 to 0 019 in Forms exceeding three parts may not produce acceptable print quality on all copies Forms must be free of die cut dust or confetti For clarity and ease of copying carbons and the image of printed results are black Forms exceeding three parts may not produce acceptable print quality on all copies Adhesive Strip Optional Total thickness of adhesive and strip should not be thicker than the bar code label 0 009 Cannot be located in the same area of the bar code label Cannot be located along the edges as specified in Ticket Areas 10 Cannot be located in any printout areas shown in Figure 15 Cannot be located on the last copy of the Report Form Tag copy 142 PN 4237182A December 1993 1 lt 3 gt A 7515489 no ES BEND
58. NE EO96 BA 0 to 100 LY MO NE EO BA 0 to 99 9 x 10 cells uL When low differential count statistics occurs the Differential 96 and s are flagged with R for Review Follow your laboratory protocol for review 42 PN 42371828 March 1995 PERFORMANCE SPECIFICATIONS Reticulocyte Reportable Range The reportable range for the STKS with Reticulocyte analysis is the range of test values demonstrated by the total system as valid see Table 8 Reticulocyte parameter reportable ranges are based upon accuracy and precision data Table 8 Reticulocyte Reportable Range Parameter Reportable Range Retic 0 20 to 30 00 Retic 0055 to 7500 x 10 cells uL or 5 5 to 750 0 x 10 cells L When Retic is lt 0 5 Retic and corresponding Retic are flagged with R for Review Follow your established laboratory protocol for review Mode to Mode Comparison Minor differences between the Primary cap piercer and Secondary manual modes are due to differences in the flow characteristics of the aspiration pathways Additionally flow characteristics vary between samples Verification of the minor mode to mode differences seen on the STKS requires elimination of effects of carryover and within mode precision in testing For these reasons the specification is based on the average values for 10 normal bloods measured in triplicate three consecutive measurements When verification is performed according to this protoco
59. P PULSE TEST RESULTS TECH DATE V XIGN4ddV COULTER COULTER CORPORATION Miami FL SERIAL NUMBER LAB 7182021A 4237182A December 1993 63 APPENDIX A APPENDIX A 64 PN 4237182A December 1993 PRECISION PULSE TEST RESULTS COULTER STKS PRECISION PULSE TEST RESULTS PRECISION V XIGN4ddV SERIAL NUMBER LAB COULTER COULTER CORPORATION Miami FL 7182022A 4237182A December 1993 65 APPENDIX A APPENDIX A 66 PN 4237182A December 1993 REFERENCE VALUES RAMP AND PRECISION COULTER STKS REFERENCE VALUES RAMP REFERENCE VALUES AVERAGE TOLERANCE FROM TO PRECISION REFERENCE VALUES AVERAGE TOLERANCE FROM XIGN4ddV TOLERANCE FROM TO 7 5 9 5 SAMPLE SERIAL NUMBER LAB 7182023A TOLERANCE RECORDED BY DATE FROM SERIAL NUMBER 7 5 9 5 LAB 95 COULTER COULTER CORPORATION Miami FL 4237182A December 1993 67 APPENDIX A APPENDIX A 68 PN 4237182A December 1993 CALIBRATION FACTORS
60. Sep Data Format PIF N Data Length 1 byte typical Note Profile can be between 1 and 9 If O this field will not be transmitted DF1 Scatterplot Group Fields Valley 1 Field Tag Sep Data Format u Data Length 3 bytes typical Valley 2 Field Tag Sep Data Format Data Length 3 bytes typical 8 XIIN3ddV Valley 3 Field Tag Sep Data Format u Data Length 3 bytes typical Valley 4 Field Tag Sep Data Format E Data Length 3 bytes typical 4237182A December 1993 1 03 APPENDIX B APPENDIX B Valley 5 Field Tag Sep Data Format _ Data Length 3 bytes typical DF 1 Scatterplot Field Tag Sep Data Format Sw nuan Data Length 4096 bytes typical The DF 1 scatterplot data is transmitted as a 4096 byte ASCII array DF 2 Scatterplot Group Field DF 2 Scatterplot Field Tag Sep Data Format Data Length 4096 bytes typical The DF 2 scatterplot data is transmitted as a 4096 byte ASCII array DIFF Histogram Group Fields V Histogram Field Tag Sep Data Format Data Length 512 bytes typical C Histogram Field Tag Sep Data Format ninh e a Data Length 512 bytes typical 104 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS S Histogram Field Tag Sep Data Format F pina s Data Length 512 bytes typical RBC Histogram Group Field RB
61. WBC at 4 0 x 10 cells uL 1 0 Replicate Precision Reticulocytes Table 4 shows Replicate Precision total system validation limits for 31 separately prepared replicates of the same specimen 38 PN 4237182A December 1993 PERFORMANCE SPECIFICATIONS Table 4 Replicate Precision Reticulocyte LIMITS Whichever is greater Retic CV Limit lt 1 00 lt 23 1 00 4 00 lt 17 4 01 15 00 1596 Paired Precision Reticulocytes Validation of paired sample precision for reticulocytes is based upon the differences of Run 1 and Run 2 specimens The limits over the clinical range of a minimum of 50 specimens from a general hospital population of no more than 3096 abnormally elevated Reticulocyte specimens Reticulocyte 496 are as follows Parameter Mean Difference SD of Difference Retic 0 4 0 8 Both requirements must be met Paired sample precision limits over the clinical range for a minimum of 50 specimens with the following characteristics are as described below e greater than 50 abnormally elevated values elevated Retic values Retic gt 4 no greater than 5 of 50 specimens have Retic values gt 20 Parameter Mean Difference SD of Difference Retic96 gt 0 5 1 5 29 59 2m d m 2 o2 O Both requirements must be met 4237182A December 1993 39 SPECIFICATIONS CHARACTERISTICS Accuracy Accuracy CBC For the CBC parameters the STKS can be
62. adjusted within the resolution of the readout to agree with a predetermined reference value at any point in the operating range Accuracy WBC Differential Accuracy of the WBC differential when determined by comparison against the reference manual differential method NCCLS H 20 n 800 or against current STKS instruments should be within the tolerance limits listed in Table 5 Table 5 gives the mean difference in percentage units against H20 Reference values at mean normal concentrations Note that an additional bias may be experienced by some laboratories due to the inherent variabilities in manual differential counting including sample population number of cells counted smear preparation quality of stain low incidence cells and interpretation of cell types monocytes variant lymphocytes and band neutrophils are most commonly affected by interpretation variances This systematic difference when present should not exceed the limits presented in Table 6 Table 5 Accuracy Tolerance Limits WBC Differential Cell Mean Difference Lymphocyte 1 0 5 5 Monocyte 0 5 9 5 ceded 1 0 Eosinophil 1 0 Basophil 0 5 Table 6 WBC Differential Bias Cell Type Limit Lymphocyte 0 to 2 7 Monocyte 0 to 2 9 Neutrophil 0 to 2 0 Eosinophil to 0 7 Basophil 0 to 0 8 40 PN 4237182A December 1993 PERFORMANCE SPECIFICATIONS Accuracy Reticulocyte Reticulocyte parameter accu
63. alibrator 8 carryover 42 CBC lytic reagent 7 CBC mode accuracy 47 analysis 21 computed parameters 30 derived parameters 30 linearity 41 sensing 21 cleaning agent 8 CLIA complexity category 10 coincidence correction 27 controls 8 COULTER CLENZ cleaning agent 8 Coulter method 17 Coulter Principle 3 counting and sizing 26 coincidence correction 27 derived and computed CBC parameters 30 Plt count and size distribution 29 Plt fitting process 29 RBC size distribution 28 red and white counting 26 sweep flow 27 voting 27 DF 2 scatterplot 31 DF 3 scatterplot 31 DF 5 scatterplot 31 DF 6 scatterplot 31 diff lytic reagent 7 differential mode analysis 24 precision 44 sensing 22 diluent 7 Diluter function 6 DMS function 6 Erythrolyse II 7 hazards of radiation 55 Hgb measurement 30 installation 11 requirements 11 intended use 1 interunit connections 13 ISOTON III diluent 7 PN 4237182B March 1995 163 INDEX known interfering substances 54 laser safety 55 leukocyte preservative 7 log sheets 59 LYSE S III diff lytic reagent 7 Material Safety Data Sheets MSDS 9 measurement of hemoglobin 30 method history 3 operating modes Primary 18 Secondary 25 operation principles 17 options 9 Auto Reporter 3 9 Graphic Printer 9 Laser Printer 9 Matrix Printer 9 wand 9 parameters computed 30 derived 30 determined by STKS 2 known inter
64. ameters 44 Replicate Precision of the WBC Differential Parameters 44 Replicate Precision of the Reticulocyte Parameters 45 Paired Precision of the CBC Differential Parameters 46 Paired Precision of the Reticulocyte Parameters 47 Accuracy 47 Accuracy of the CBC Differential Parameters 47 Accuracy of Reticulocytes 49 Reference Ranges 50 WEC Differential Reference Range 50 PN 4237182B March 1995 CONTENTS Retic Reference Range 51 Retic Specimen Stability 52 Mode to Mode Performance of STKS CBC Differential 53 Interfering Substances 54 CBC 54 Differential 54 Reticulocytes 54 5 PRECAUTIONS HAZARDS 55 5 1 SAFETY PRECAUTIONS 55 5 2 RADIATION HAZARDS 55 APPENDIX A LOG SHEETS 59 APPENDIX B TRANSMISSION TO A HOST COMPUTER 81 B l DESCRIPTION 81 B 2 HARDWARE INTERFACE 82 Connector Pinouts 83 Handshake 83 COMMUNICATION PARAMETERS 84 Modes 84 Time Out 84 Baud Rate 84 Data Bits 85 Parity 85 Stop Bits 85 Block Size 85 Spooler Enable 85 Compatibility 85 Graphics Data Enable 86 B 4 DMS TO HOST COMMUNICATIONS 86 Datalink Protocol 86 Full Handshake 86 No Handshake 88 Data Block Structure 88 Message Structure 88 Group Definition 92 General Information Group Fields 93 CBC Parameter Group Fields 95 Diff Count Parameter Group Fields 96 iv PN 4237182B March 1995 B 5 B 6 B 7 CONTENTS DIFF Percent Parameter Group Fields 97 RETICS Parameter Group Fiel
65. are sent to the Platelet Analog to Digital Converter PLAT ADC card where they are digitized The digital information from each aperture is sent to the DATA MEM card where it is stored 64 channel size distribution histograms After the sensing periods are completed these histograms are sent through the PS MON 2 card to the Analyzer computer for analyses Before proceeding with the Plt fitting process the Analyzer computer verifies that the Plt count per aperture is greater than 20 x 10 cells nL Next the computer smooths the histogram from each aperture and locates in certain areas of each of the smoothed curves a maximum point and two minimum points Using a least squares fit method for a log normal curve a curve is fitted to the portion of the histogram between the two minimum points The computer verifies that each of the fitted curves is positive that their modes are from 3 to 15 fL and that the PDW is less than 20 The fitted curves have a range of 0 to 70 fL Lastly the computer votes on the Plt count MPV and PDW derived from the three fitted curves If any of these criteria are not met a no fit condition exists A NON POS MODE OUT or PDW OUT message appears on the Analyzer in the SYSTEM RUN mode v n 23 md 2 If a no fit occurs the computer smooths the histogram from each aperture and locates in certain areas of each of the smoothed curves a maximum point and two minimum points The c
66. bytes typical Comments CASSPOS output is cassette number cassette position Reference RBC Count Field Tag Sep Data Format rlrlelel 5 char numeric data max 8 XIIN3ddV B 5 HOSTTO DMS COMMUNICATIONS HOST WORKLIST Datalink Protocol The DMS requires full handshaking to receive data The protocol is similar to that used for DMS to Host transmissions with the SYN character replaced with the ENQ character The data is transmitted as a sequence of up to 255 blocks of data of 256 or 128 bytes each Generally these blocks contain 256 data bytes each but due to the unique needs of differing hosts the system is configurable to allow shorter blocks with 128 data bytes 4237182A December 1993 111 APPENDIX B APPENDIX B Sender host computer Receiver DMS Digiboard SYN indicates receiver busy Prepare to receiv sample s record ENO gt a 5 X X gt 2 byte data block lt ACK NAK indicates Receiver Abort STX 2 byte Exactly 256 or 128 4 byte blk number data bytes CRC Send block and await response Repeat data block and response until done ENO All Done lt ACK NAK ENQ After each block ACK NAK ENO DLE Accept Reject ct ct The last ACK NAK sent by DMS Digiboard indicates to the Host whethe
67. ds 97 Comment Group Fields 98 Flag Groups 98 Demographics Group Field 100 DF1 Scatterplot Group Fields 103 DF 2 Scatterplot Group Field 104 DIFF Histogram Group Fields 104 RBC Histogram Group Field 105 PLT Histogram Group Fields 105 DFS LS Scatterplot Group 105 DF 6 OP Scatterplot Group 106 RETICS Histogram Group Fields 107 DIFF Latex Parameter Group Fields 108 RETIC Latex Parameter Group Fields 108 Control Information Group 109 HOST TO DMS COMMUNICATIONS HOST WORKLIST 111 Datalink 111 Protocol 111 Data Block Structure 114 Presentation 114 Message Structure 114 Message Definition 115 ASCII TABLES 120 7 Bit ASCII Codes 120 Valid Host Communications ASCII Codes 121 CRC 121 CRC Algorithm 121 CRC Example Written in ASM86 123 CRC Example Written in C 124 APPENDIX C BAR CODE LABEL SPECIFICATIONS 125 Cl 2 C 4 C 5 GENERAL 125 OPTICAL CHARACTERISTICS at 880 nm 10 and 633 nm x1096 125 PRINTING METHOD 126 LABEL THICKNESS 126 NE WE RATIO 126 PN 4237182B March 1995 CONTENTS C 6 LABEL DIMENSIONS AND DATA 126 C ACCEPTABLE BAR CODES 126 C 8 CHECKSUM ALGORITHM 129 Interleaved 2 of 5 129 Codabar and NW7 130 Japan Red Cross NW7 Decoding 131 Code 39 Bar Code 133 Code 128 134 APPENDIX D AUTO REPORTER 3 TICKET SPECIFICATIONS 139 D 1 GENERAL INFORMATION 139 0 2 CUSTOMIZING THE FORM 139 D 3 SPECIFICATIONS 14
68. e the reagent blank signal level provides a reference to which the sample signal is compared u Fa lt cc ac 3 7 SCATTERPLOT DEVELOPMENT The Analyzer performs series of operations on the stored digital raw values to identify subpopulations and calculate percentage values It also produces the scatterplot displays for visual representation of the WBC and Reticulocyte RBC populations Largest concentration is indicated on the scatterplot display by intensity On a black and white graphics printout darkest represents the greatest concentration on the monitor or a color graphics printout yellow represents the greatest concentration followed by red green and blue DF 1 Scatterplot A two dimensional scatterplot shows four of the five populations lymphocytes LY monocytes MO neutrophils NE and eosinophils EO The fifth population basophils BA is behind the upper right quadrant of the Lymphocyte population For the purposes of the display 30 PN 4237182A December 1993 DF 2 Scatterplot DF 3 Scatterplot DF 5 Scatterplot DF 6 Scatterplot SCATTERPLOT DEVELOPMENT the axes are labeled Volume and DF 1 DF 1 isa discriminant function derived primarily from the light scatter measurement Volume is determined by the low frequency impedance measurement DF 2 discriminant function is another perspective of the five differential populations and is derived primarily from conductivity
69. e an even number of characters as required by the symbology Example MESSAGE 8 PARITY E STEP2 1 5 7 13 STEP 3 2 6 8 3 48 4 13 48 61 5 61 9 70 Therefore the checksum is 9 and the final decoded message is 01256789 Codabar and NW7 Note Codabar and NW7 codes have the same character set and the same checksum algorithm The difference between these two codes is that Codabar has 18 different bar and space dimensions and NW7 has only NE and WE structure APPENDIX C The value assigned to each of the characters is presented in the following table CHARACTER VALUE CHARACTER VALUE 10 11 12 13 14 15 16 17 18 19 The checksum technique is e character value of a message is obtained from the above table and added together 130 PN 4237182B March 1995 CHECKSUM ALGORITHM e This sum is divided by 16 and the remainder corresponds to the value of the checksum character Examples 1 2 3 4 7 1 3 20 1 REMAINDER 4 The value 4 corresponds to character 4 therefore the checksum is 4 and the final decoded message is 2347134 2 MESSAGE 11 11 13 13 15 15 15 15 108 S rn 108 _ 6 REMAINDER 12 5 16 5 The value 12 corresponds to character therefore checksum is and the final decoded message is Japan Red Cross NW7 Decoding Japan Red Cross Hospitals use the following NW7 values CHARACTER VALUE 0 0
70. e sample tube is reseated in the cassette The needle rotates into the rinse trough where it is rinsed with diluent Delivery The center section of the BSV rotates and segments the sample into two separate volumes Beginning a few seconds before the delivery of the dilutions to the appropriate baths 5 psi of pressure is sent to the WBC bath This pressure allows drainage of any residual liquid in the WBC bath thus preventing carryover The pressure continues during delivery and forms bubbles that mix each cell suspension before sensing begins At the beginning of the delivery any residual rinse in the Hgb cuvette drains into the waste chamber and the waste chamber drains Diluent from the diluent dispensers drives the separated volumes of sample from the BSV to the baths 79 n 23 md m oO 2 One volume of sample 1 6 pL is delivered with 10 mL of diluent to the RBC bath This dilution is used for RBC Plt counting and MCV Plt sizing The other volume 28 pL is delivered with 6 mL of diluent to the WBC bath This dilution is used to count WBC and develop Hgb During delivery to the WBC bath 1 mL of lytic reagent is added to the dilution to lyse the red cells and convert Hgb The final dilution in the WBC bath is 1 part whole blood in a total volume of 251 parts The final dilution in the RBC bath is 1 part whole blood in a total volume of 6250 parts At the same time the lytic reagent is dispensed the Hgb blank pump trans
71. e the instrument and cycled in the Secondary mode The STKS uses the Triple Transducer Module to measure these parameters Reticulocyte percent RET the number of reticulocytes per 100 RBCs directly measured and reported as a percentage of RBCs Reticulocyte number RET the absolute number of reticulocytes calculated from RET and RBC number Expressed and reported as 10 cells uL or 10 cells L Three measurements are made as each cell passes through the flow cell aperture 1 The low frequency impedance measurement defines the cells volume 2 high frequency impedance measurement indicates the cells internal conductivity or opacity Fa lt cc ac 3 Thelight scatter measurement indicates the cells structure and shape 3 5 COUNTING AND SIZING Red and White Counting Each bath RBC and WBC has three discrete apertures that function as independent systems When aperture current is applied to the apertures from the Aperture Current Signal Generator AP CUR SIG GEN card there is a delay During this delay the electronics are conditioned to perform the counting and sizing of the sample At each aperture the pulses are gathered for 4 seconds These pulses are amplified on the Red or White Preamplifier RED PRE AMP or WHT PRE AMP cards and displayed at the Analyzer CRT module These pulses are sent to the Red White Counter RED WHT CTR card where pulses from the RBC bath
72. ecksum generation procedure Do not use these values Code set A 0 64 through 102 Code set B 0 95 through 102 Code set C 100 through 102 The checksum value see table is equal to the modula 103 sum of the value of the start character and the weighted values of the data special characters The weights are one for the first data special character and continuing with two three four and so forth for the following data special characters For example a label contains a START character Code C Data 25 a Check character a STOP character The value of the Start character C is 105 and the data character for 25 is 25 The weight of the first data character is one so the check character value is calculated as follows 105 25x 1 130 where 105 and 25 are the values and 1 is the weight 134 PN 4237182A December 1993 CHECKSUM ALGORITHM The checksum is equal to 130 modula 103 the remainder of 130 divided by 103 130 103 1 remainder 27 Therefore the check character equals character value 27 which is in Code Set A For additional information on this procedure refer to AIM USS 128 Rev 1986 published by AIM Inc 1326 Freeport Road Pittsburgh PA 15238 je bee s w 05 amp s o xjojo n5 o m o gt gt gt m gt lt zl 4237182A December 1993 1 35 APPENDIX C APPENDIX C 136 PN 4237182A December 1
73. ed in laboratories for these red cell indices t When the internal value is greater than the displayed format the value will be displayed with one less decimal place PN 42371828 March 1995 151 APPENDIX F APPENDIX F Table 34 5 1 2 and S l 6 Format Reporting Units Parameter Conv Unit Display Factor Label Format WBC 40 EG 999 9 NEG oo 9 999 y _ 001 ratio 9 999 MOX 00 ratio 9999 Eo 001 9 999 BA oo ratio 9999 NE NE x WBC 100 EALA 999 9 LY 100 1 0 107 999 9 MO xWBC 100 10 10 999 9 EO E0 xwac 100 10 107L 999 9 BA won 100 10 10 9999 RET E 0 01 9999 RET RET x RBC 100 a 9999 109 L Parameter for Investigational Use Only ForS L 6 format t Calculation formula commonly used in laboratories for these red cell indices t When the internal value is greater than the displayed format the value will be displayed with one less decimal place 152 PN 4237182B March 1995 REPORTING UNITS Table 35 5 1 3 Format Reporting Units Factor Label Format NE NE x WBC 100 999 9 LY mo x WBC 100 MO MO x WBC 100 5 999 9 10 10 10 E Es EE 10 10 10 tor 999 9 RUNS EO O xWBC 100 10 10 uL 999 9 BA 100 10 10 uL 9999 E 10 to 99 99 10 g dl 9999 001 EUN
74. ed specimens of the Differential parameters based on 44 nonflagged clinical specimens of whole blood collected K EDTA Table 28 Mode to Mode Comparison Diff Parameter Mean SD Difference Lymphocyte 0 81 Monocyte 0 78 Neutrophil 1 36 Eosinophil 006 0 31 Basophil 0 45 1 00 xm 2m A m 2 4 ON no 4237182A December 1993 53 SPECIFICATIONS CHARACTERISTICS Interfering Substances CBC WBC Certain unusual RBC abnormalities resist lysing NRBC fragmented WBC any unlysed particle greater than 35 fL very large platelets RBC Very high WBC count high concentration of very large platelets auto agglutination Hgb Very high WBC count severe lipemia heparin certain unusual RBC abnormalities that resist lysing MCV Very high WBC count high concentration of very large platelets auto agglutination RDW _ Very high WBC count high concentration of very large platelets auto agglutination Plt Very small erythrocytes or leukocytes or cell fragments may cause no fit conditions in some cases The STKS provides accurate Plt counts in the presence of most hemolytic disorders Chemotherapy may affect certain samples Het MCH MCHC Known interferences related to the parameter used for computation Differential m Zi o9 FE ul lt La hz 0 Interfering substances for the diff parameters High triglycerides affect lysing Reticulocy
75. ed using weight 2 5862104376859 DIGIT POSITION Right Justified WEIGHT 2 Result 85 20 21 6 i 0 0 54 0 204 12 6 14 54 0 0 54 160 160 11 14 REMAINDER 6 When the REMAINDER is 0 0 is the check digit 11 6 5 The value 5 corresponds to character 5 therefore the checksum is 5 and the final decoded message is 0232290065 Code 39 Bar Code gt a m gt lt zl The value assigned to each of the characters is CHARACTER VALUE CHARACTER VALUE CHARACTER VALUE o Fr 5 v gt 3 c v 2 I Sr n j a s ps x 5 4 m 5 35 amp s jaf l7 s s N 25 35 o a A P o wf a z x D Ei E PN 4237182B March 1995 1 33 APPENDIX C APPENDIX C Code 128 The checksum technique is e character values of the message are obtained from the above table and added together e This sum is divided by 43 and the remainder corresponds to the value of the checksum character Example 28 29 30 31 32 33 34 15 232 232 zt 5 REMAINDER 17 17 H CHECKCHARACTER The value 17 corresponds to character H therefore checksum is H and the final decoded message is STUVWXYFH The checksum character immediately precedes the stop character The checksum character used with Code 128 must conform to the AIM USS 128 ch
76. eing Hgb and reducing the size of cellular debris to a level that does not interfere with leukocyte counts Diff Lytic Reagent Erythrolyse II lytic reagent rapidly lyses erythrocytes and reduces the cellular debris to an insignificant level without altering the leukocytes The Erythrolyse II used with the STKS is included in the COULTER SCATTER PAK as PAK LYSE Leukocyte Preservative StabiLyse leukocyte preservative preserves the leukocytes in their near natural state for differentiation through the volume conductivity and light scatter measurements The StabiLyse used with the STKS is included in the SCATTER PAK as PAK PRESERVE 4237182A December 1993 USE AND FUNCTION Retic Reagents The COULTER ReticPrep reagent kit includes two reagents Reagent A a special formula of New Methylene Blue NMB and Reagent B a clearing solution Use reagents when manually preparing samples for reticulocyte analysis Follow the preparation instructions supplied with the kit lt o z Reagent A is specially formulated new methylene blue dye that precipitates the basophilic RNA networks found in reticulocytes Reagent B then clears the hemoglobin from the RBCs without removing the precipitated dye RNA complex Cleaning Agent COULTER CLENZ cleaning agent prevents protein buildup and keeps the system clean Daily use eliminates routine aperture bleaching Control Material e COULTER 5C cell cont
77. eld in the DIFF Count Parameter Group will have the following format Tag Sep Data Format 5 char numeric data max 1 char space separator min 3 char flag data max Tags LY 0 NE EO96 Numeric Data If the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following RETICS Parameter Group Fields Each field in the RETICS Parameter Group will have the following format Tag Sep Data Format 5 char numeric data max 1 char space separator min 4237182A December 1993 97 APPENDIX B APPENDIX B 3 char flag data max Tags RET RET MT OTHER and MI parameters are not for Diagnostic Use Numeric Data If the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following s Incomplete Computation Flow cell clogged Diagnostic Parameters MRV and MI parameters are only sent when a Retics II or Retics III option is installed Comment Group Fields This group will be transmitted with the first test only Comment Field Tag Sep Data Format xIx x Data Length 64 bytes typical Flag Groups The four Flag Groups will be transmitted with the first test only Suspect Flag String Up to 128 Characters Sep s u s P e e T 98 PN 4237182
78. ement of volume conductivity and light scatter is used to discriminate reticulocytes from WBCs mature RBCs and Plts 1 3 SYSTEM FUNCTION The STKS is available in 100 115 and 230 V 50 or 60 Hz configurations This is a modular system that consists of the following units PN 4237182B March 1995 5 USE AND FUNCTION Power Supply This unit consists of two assemblies The Electronic Power Supply assembly provides the regulated and unregulated voltages required by the circuitry of the system The Pneumatic Power Supply assembly is the source of air pressure and vacuum Z lt o uz Diluter This unit is the primary operating unit of the system It performs the mixing transporting pipetting diluting lysing and sensing unctions The majority of all controls and indicators needed for normal daily operation are on the front of the Diluter Analyzer This unit controls the electronic sequence of each operating cycle and calculates and analyzes the results It receives count and size information directly from the Diluter while the sample is being cycled then it counts measures and computes the parameters The Analyzer then sends this information to the DMS Data Management System DMS The DMS receives information from the Analyzer displays it stores it and transmits it to the Graphic Printer Ticket Printer and a host computer The DMS provides storage for results including scatterplots and
79. ength of the waste line supplied with the system contact your Coulter Service Representative before making any modifications The waste drain tubing rear panel of the Diluter supplied with the system can be connected to either an open drain less than 76 cm 30 in above the floor a waste container with a minimum capacity of 5 gal 20 L z mi 2 gt gt 2 In either case the maximum waste line length is 3 7 m 12 ft When using an open drain instead of a waste container the waste level sensing tube can be inserted into the drain Be sure that the end of the tube is not below the normal level in the drain 2 3 INTERUNIT CONNECTIONS CAUTION To ease reagent priming and prevent a siphoning effect do not place any reagent containers above the level of the Diluter place both CBC and SCATTER PAK Iytic reagent containers on the same level as the Diluter The system is supplied with all power and signal cables tubing and pressure and vacuum lines required for interunit connections Figure 2 illustrates the interunit power and signal cable connections Figure 3 illustrates the pneumatic hydraulic connections 4237182A December 1993 13 INSTALLATION KEYBOARD INST O CABLE z lt E l lt z ANALYZER DMS POWER CABLE DILUTER
80. ensing area If punch holes exist limit holes to 1 8 in in diameter Holes larger than 1 8 in diameter must be kept out of this area to avoid jams Having a definition of codes is helpful The definitions can appear only on the Laboratory Copy if Chinese blockout obscures codes on other copies gt D m gt lt When using the BAR CODE option reserve this area on Part 1 for labels No characters should be printed here On any copy except Part 1 this area can be omitted Reserve this area for CASSETTE NO in case of incomplete aspiration Additional Comment or Addressograph area Reserve this area for instrument printout of suspect and definitive messages Comment area Along each edge of the form an area of 0 45 in in width should be free of labels We suggest a screen indicating this area 4237182A December 1993 143 APPENDIX D APPENDIX D 11 12 13 14 15 16 Form width 3 250 0 00 0 02 Form length 10 019 maximum 8 970 minimum Center of last line printed to bottom of form is 1 690 minimum Reserve this area for CASSETTE NO TIME ID and DATE Center of bar code scanner to center of first line printed is 1 20 0 01 Top of form to center of first line printed is 2 497 0 015 Closed end of form stub When perforations are used a perforation on the last tag copy must be at least 1 1 2 in from the top of the form Top copies may have perfora
81. entering the aperture CBC Sensing System Vacuum equivalent to 6 in of mercury draws a precise volume of suspension from each bath through the three apertures At the same time sweep flow is drawn behind the RBC apertures to prevent cells from reentering the sensing zone When the vacuum starts to draw the suspension current is supplied to the electrode The electrical path allows the number and volume of each cell pulled through the apertures to be sensed While the sample in each bath is sensed the Hgb blank is read by the photometer and this reference voltage is retained by the Analyzer 79 n 23 md 2 CBC Analysis the Baths The RBC and Plt data collected at the RBC bath and the WBC and Hgb data collected at the WBC bath are sent to the Analyzer There the data is coincidence corrected counted e scaled for calibration and dilution voted on e the RBC size distribution curves histograms are compiled e the Plt size distribution curves histograms are compiled The RBC histogram derives MCV and RDW parameters the Plt histogram derives Plt and MPV parameters These parameters and histograms are sent to the DMS along with the WBC count The WBC 4237182A December 1993 21 OPERATION PRINCIPLES bath drains into the Hgb cuvette The liquid in the cuvette is read photometrically and the Hgb concentration is calculated by comparing this reading with the Hgb blank reference voltage
82. epresentation of the hexadecimal value MS LS Two Byte ASCII representation of Hex CHAR CHAR value between 00 and FF 0 to 255 Group Count Each test identification has a Group Count that identifies the number of groups contained within the test Valid group counts can be from 0 255 The group count uses two characters to give the ASCII representation of the hexadecimal value MS LS Two Byte ASCII representation of Hex CHAR CHAR value between 00 and FF 0 to 255 90 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Group Number Each group identifier has a Group Number that identifies the group number contained within the group identifier Valid group numbers can be from 0 255 The group number uses two characters to give the ASCII representation of the hexadecimal value MS LS Two Byte ASCII representation of Hex CHAR CHAR value between 00 and FF 0 to 255 Field Count Each Group has a Field Count that identifies the number of fields contained in the Group Valid field counts can be from 0 255 The field count uses two characters to give the ASCII representation of the hexadecimal value MS LS Two Byte ASCII representation of Hex value CHAR CHAR between 00 and FF 0 to 255 Fields 8 XIaN3ddV Each Group is made up of variable length fields which may or may not be padded with SP 20H or HT 09H characters A field may have a variable length Tag preceding the data separated with one or more SP
83. es that they are reporting the most accurate results possible There are five basic methods now in use in hematology to monitor automated instrument results performing daily instrument checks using commercially available controls reviewing patient results participating in an interlaboratoy control program using X Analysis SR In addition the STKS system uses a comparison procedure for controlling diff parameters using instrument diff and manual diff results Stability One of the requirements for a good quality control material the parameter values to be measured must not fluctuate on their own but remain stable Target Value The constant for each index calculated from a large number of patients of varying ages and disease states The values are the same for all acute care general hospital populations X Analysis A method of quality control that frequently compares patient indices with known target values Used to monitor automated instruments in hematology 162 PN 4237182B March 1995 INDEX U accuracy CBC Diff parameters 47 reticulocyte parameters 41 Specification 40 Analyzer unction 6 aspiration 19 Auto Reporter 3 ticket specifications 139 bar code label specifications 125 bar codes Codabar and NW7 130 Code 128 134 Code 39 133 Interleaved 2 of 5 129 Japan Red Cross NW7 131 bar code wand 145 to install 146 to scan with 146 calibration stability 36 c
84. fering substances 54 performance characteristics 44 accuracy of CBC parameters 47 known interfering substances 54 precision of CBC parameters 44 precision of the differential parameters 44 performance specifications 37 accuracy 40 CBC linearity 41 mode to mode comparison 43 operating range 42 precision 37 performance specifications carryover 42 physical specifications 35 Plt count and size distribution 29 Plt fitting process 29 power supply function 6 precautions 55 precision of differential parameters 44 specification 37 precision of CBC parameters 44 primary operating mode 18 aspiration 19 backwash and rinse 25 CBC analysis in the baths 21 CBC sensing system 21 delivery 19 differential multiparameter sensing 22 operating cycle 18 transport 18 WBC differential analysis 24 radiation hazards 55 RBC size distribution 28 reagents 7 calibrator 8 CBC lytic reagent 7 cleaning agent 8 controls 8 COULTER CLENZ cleaning agent 8 diff lytic reagent 7 diluent 7 Erythrolyse II 7 ISOTON III diluent 7 leukocyte preservative 7 LYSE 5 diff lytic reagent 7 Retic reagents 8 StabiLyse 7 references 157 reporting units 149 164 PN 4237182B March 1995 INDEX Retic accuracy characteristics 49 analysis 26 precision characteristics 45 reagents 8 relerence range 51 reportable range 43 specimen stability 52 S CAL kit 8 safety precautions 55 sample delivery 19
85. fers 5 mL of diluent into the Hgb cuvette The vent section of the piercing needle is rinsed then dried by 5 psi of pressure The center section of the BSV returns to the aspirate position 4237 182 December 1993 19 OPERATION PRINCIPLES LOADING BAY FILLED WITH CASSETTES CN RIGHT LIFT PLATFORM ROCKER BED PLATFORM TRIPLE TRANSDUCER MODULE COMPARTMENT INSIDE o u Fa uz DILUTER KEYPAD 3778 ROCKER BED Figure 5 Transport System and Triple Transducer Location 20 PN 4237182A December 1993 PRIMARY OPERATING MODE At the same time as the segmented parts of the sample are being delivered to the baths the Diff segmenting module segments an additional sample of approximately 24 pL of the blood for the WBC differential The sample and approximately 0 53 mL of Erythrolyse II is delivered to the mixing chamber which agitates to mix them thoroughly During the mixing process approximately 0 2 mL of StabiLyse enters the mixing chamber to preserve the leukocyte populations and the instrument initiates the sheath stream of diluent in the triple transducer flow cell The instrument injects the sample into the center of the sheath stream and activates the flow cell aperture current The laminar flow guides the sample through the center of the flow cell aperture the sheath stream on the exit side of the flow cell aperture prevents the samples cells from re
86. ffected parameter is derived by averaging the data from the two remaining apertures If the data from the two or three apertures is not within an established statistical range from each other the parameter and histograms are totally voted out 79 n U md 2 Sweep Flow The sweep flow is a steady stream of diluent that flows behind the RBC aperture during the sensing period This prevents cells from reentering the sensing zone and being counted as platelets See Figure 8 4237182A December 1993 27 OPERATION PRINCIPLES WASTE CELL 7 CELL SENSING x d S d G T N BR Re gt de E Na ey elm SENSING Z d B o d ZONE SWIRLIN t t EFFECT NO SWEEP SWEEP FLOW 7016005A Figure 8 Sweep Flow Size Distribution The three Red White Editor RED WHT EDITOR cards and the Delay Aperture Cleaning DLY APERT CLNG card edit RBC and WBC pulses to exclude pulses produced by cells that may have passed through the aperture near the edge of the opening or at an angle rather than at the center There is a RED WHT EDITOR card for each aperture Fa lt cc ac After editing the three sets of both the RBC WBC pulses sent to the Red White Analog to Digital Converter RED WHT ADC card where they are digitized That is each pulse is converted to a number that corresponds to the size of the cell The digital inf
87. for Standardization in Haematology Recommendations or reference method for haemoglobinometry in human blood ICSH Standard EP6 2 1977 and specifications for international haemiglobincyanide reference preparation ICSH Standard EP6 3 1977 J Clin Path 1978 31 139 143 15 Gauthier et al Human leukocytes their size distribution and mean corpuscular volume Can Med Assn J 1967 97 793 796 16 Hughes Jones Differential leukocyte counts by volume distribution analysis Brit J Hem 1974 28 148 17 Wycherly MM and O Shea Abridged differential leukocyte counts provided by a COULTER CHANNELYZER analyzer in a routine haematology laboratory J Clin Path 1978 31 271 274 18 Richardson Jones A Hellman R and Twedt D The Coulter Counter Leukocyte Differential Blood Cells 1985 11 203 240 19 Hoffman RA and Britt WB 1979 Flow System Measurement of Cell Impedance Properties J Histochem Cytochem 27 234 20 Leif RC Schwartz S Rodriguez CM Pell Fernandez L Groves M Leif SB Cayer M and Crews H 1985 Two Dimensional Impedance Studies of BSA Buoyant Density Separated Human Erythrocytes Cytometry 6 13 21 21 Coulter WH and Hogg WR 1970 Signal modulated apparatus for generating and detecting resistance and reactive changes in a modulated current passed for particle classification and analysis U S Patent 3 502 974 22 Miale J Laboratory Medicine Hematology C V Mosby Company 3rd Edition p 22 1967 23 Co
88. for these parameters do not print and the line spaces are skipped 3 Contains strict formatting layout for some areas The SHADED areas in the example in Figure 15 indicate the restricted areas that cannot be adjusted or changed in any way The DMS program does not allow you to disable any parameters other than Pct or PDW or to reorder the parameters D 2 CUSTOMIZING THE FORM Coulter no longer customizes tickets We recommend that you 1 Use vendors that are familiar with Coulter forms especially the Auto Reporter forms 2 Strictly follow specifications given in the Specifications section 4237182A December 1993 1 39 APPENDIX D PART 1 PART 2 amp 3 7515489 B 6 89 7515489 B R 8 89 DO NOT BEND OR FOLD COULTER DO NOT BEND OR FOLD s HEMATOLOGY 257 sen HEMATOLOGY x CODE DEFINITIONS FOR RESULTS t t Resulisaverpuntablerange L Hesuluis lower than tab action lirit Results voted out Resutishigherthan tab action limit Incomplete computation occurred Resulexceeds linearity Reviewresults X Abnormal conditior Abnormal concition caused otner S Suspect parametersiofiag AFFIX BAR CODE HERE TEST prorite wec O rec prot TEST wec rec pct REODBY DATE REC D DATE PERFORMED BY DATE PERFORMED BY CASS NO ASP NO 5 NORMAL OP CODES i ues
89. g quite small batches from the patient population A 20 patient sample batch is a typical size and is used in the DMS The formula Figure 9 is easily implemented with a computer Its function is to enable reliable estimates of the values for these parameters to be made for a population from small samples of that population It is superior to the traditional moving average because it reacts quickly to changes Small batch sizes allow for more frequent therefore tighter quality control The formula both trims the data by giving less weight to outliers and smooths it by incorporating information from the previous patient batch in the analysis of the current batch As each sample is processed the mean of the previous set of samples is subtracted from each of the red cell indices The square root of this deviation difference between the means is stored After 20 samples have been processed the sum of the square roots is divided by 20 The result is squared to recover the mean average deviation The individual deviations carry a positive or negative sign so then it can be added to or subtracted from the corresponding previous means The resulting new mean is then used for the succeeding batch of 20 samples The hematology system is considered in control when the batch means are within established limits of the target values Using the X Analysis the direction and amount of change due to the instrument the reagent flagged samples or sample
90. gt 4 5 m XOR AL AH X gt gt 4 lt 2 MOV AH AL Save X MOV CH AL Save X SHR AL 3 Then AL X gt gt 3 XOR AL BL AL CRCLSB XOR X gt gt 3 SHL 4 AH X lt lt 4 XOR AL AH CRCMSB CRCLSB MOV BH AL X gt gt 3 XOR X lt lt 4 lt 3 MOV AL CH Recover X in AL SHL AL 5 AL X lt lt 5 XOR AL CH AL X X lt lt 5 OV BL AL CRCLSB X X lt lt 5 lt 4 POP CX RET GET_CRC_BYTES ENDP 4237182A December 1993 123 APPENDIX B APPENDIX B CRC Example Written in C The following is an example of CRC16 code written in C void calc crc unsigned char data byte data byte crcmsb data byte data byte 16 crcmsb crclsb data byte 8 data byte 16 crclsb data byte data byte 32 124 PN 4237182A December 1993 APPENDIX C BAR CODE LABEL SPECIFICATIONS 1 GENERAL C 2 OPTICAL CHARACTERISTICS at 880 10 and 633 nm 10 bar code consists of black lines bars white lines spaces which are called elements There are narrow elements NE and wide elements WE their arrangement is determined by the code IMPORTANT For accurate reading by the scanner it is important that bar code labels for specimen tubes and printout tickets adhere strictly to the specifications given in this Appendix Labels that meet these
91. handling can be detected Because of the characteristic appearance of the graphs of the X results it is also often possible to identify changes u Fa lt cc ac Here s the Xg formula N X Bi X B i 1 seN 2 SGN X j i X B i 1 1 F jt N 2 SGN X j i X B i 1 Kunze 2 F N ith XB value i 1 th value the jth X value in the ith batch the arithmetic sign of number in parentheses number of samples in the batch symbol used to represent multiplication 0924 Figure 9 The X Formula 32 PN 4237182A December 1993 Adjusting Initial X Target Values X ANALYSIS IN THE DMS The DMS calculates and displays the percent difference between each batch mean and its corresponding preset target value The percent difference is derived as follows 1 MCV percent diff MOY Bath Mean 1 x 100 MCV Target Value 2 MCH percent diff 1 x 100 Target Value 3 MCHC percent diff 1 x 100 MCHC Target Value 79 n 23 md 2 The recommended target values for initial entry 895 MCH 30 5 34 0 samples run laboratory values established the recommended target values can be adjusted to fit your laboratorys population After 20 X batches have been analyzed calculate the mean and CV for each of the X indices The mean values should not differ from the targe
92. his field is ignored in STKS DMS 2A B 6 ASCII TABLES 1 Bit ASCII Codes 0 0 0 0 1 1 1 1 0 0 t 1 0 0 1 1 Fe 1 0 1 0 T 0 T Y Y Y 65 517 35 2 Sl XXX0000 NUL DLE SP 0 X p XXX0001 SOH DCl 1 A Q a q XXX0010 STX DC2 2 B R b r 0011 DC3 3 5 5 XXX0100 EOT DC4 4 D T d t XXX0101 ENO NAK 5 E U e u XXX0110 ACK SYN amp 6 F V f X BEL r 7 G W g XXX1000 BS CAN 8 H X h x XXX1001 HT EM 9 I Y Y y XXX1010 LF SUB i J 7 3 2 XC X36 10 35 221 VT ESC K k XXX1100 FF FS lt L 1 X XX11 01 CR GS m XXX1110 SO RS gt N SSO WSQ WV SI US DEL 120 PN 4237182A December 1993 ASCII TABLES Valid Host Communications ASCII Codes 0 0 0 0 1 i 1 0 0 1 1 0 0 1 1 OO 1 0 1 0 1 0 1 TOUS Pd XXX0000 DLE SP 0 P p X X X 0 0 01 DC1 1 0 XXX0010 STX 4 2 B R b r 0011 3 5 5 XXX0100 5 4 D T d X XX 05 5 E U e u 0110 ACK SYN amp 6 F V V XXX Qm uL 5 6 W g w XXX 1000 8 H X h x 1001 HT 9 I Y i y X XX1 01 0 LF 2 J 2 7 2 L K k XXX 1100 z lt L 1 XXX1101 CR _ m X XX 0 gt N i n MX XL 1211 27 Highlighted only used for Datalink control 8 XIIN3ddV 7 CRC CRC Algorithm The CRC algorithm used is a modified CCITT CRC
93. his instrument had been independently validated against the following methods WBC COULTER ZBI analyzer Certified volumetric glassware RBC COULTER ZBI analyzer Certified volumetric glassware Plt COULTER ZBI analyzer Certified volumetric glassware Hgb NCCLS method H15 A MCV NCCLS packed cell volume method H7 A 4237182A December 1993 47 SPECIFICATIONS CHARACTERISTICS For WBC differential parameters the reference values were provided by the method described in NCCLS publication H20 A n 800 Evaluation of CBC accuracy by subtraction of paired test results for 226 specimens is given in Table 17 The magnitude of the mean differences expresses accuracy The dispersion of differences SD expresses the inclusive errors of imprecision and bias Table 17 Accuracy CBC Clinical Range WEG 03 Accuracy of the Differential parameters is expressed as mean difference between reference method H20 A values and the STKS values for 130 normal subjects See Table 18 o 9 E lt oc lt o e HE lt 9 Lu 72 Table 18 Accuracy WBC Differential Cell Type Clinical Range Mean Low Mean High Difference 48 PN 4237182A December 1993 PERFORMANCE CHARACTERISTICS Table 19 lists the numbers of abnormalities that were studied in the paired analysis testing according to NCCLS H20 A criteria for abnormal specimen types Table 19
94. his transfer takes place if Transmit to Host option is turned on and there is positive sample identification The positive identification can be either CASS POS or ID 1 or both The transmission specification consists of data link low level and presentation high level protocols Data link protocol provides the means of transmitting data without any regard to actual information Presentation protocol describes the actual information and its format The high level protocol of the DMS 2A is capable of transmitting multiple results of multiple tests and of control parameters IMPORTANT To satisfy requirements the host receiver must parse for all of the data DO NOT ASSUME FIXED OFFSETS AND OR FIXED FIELD LENGTHS STKS Host Communication Options Transmission 1G 1 Retic Retic No QC Data No Profile s and No Test IDs Collated No CBC Diff Retic B 2 HARDWARE INTERFACE The system is equipped with an auxiliary connector P3 on the back side of the DMS that lets the system interface with a host computer via a 82 PN 4237182B March 1995 HARDWARE INTERFACE Standard EIA type 25 pin connector and uses EIA Standard RS 232 C signals This is a Data Terminal Equipment DTE configuration Connector Pinouts The DMS Host communications uses only the following signals P3 Pin No Flow Direction n Prio fromus To Ds i eye Send er From DB 5 caro Send C15 To DS Baa Se Rei
95. ignores all hardware and software host responses In addition in the No Handshake mode the DMS does not send a SYN prior to transmitting the data Byte of bytes il STX 1 byte 2 BLK NBR MS CHAR 1 byte 3 BLK NBR LS CHAR 1 byte 4 DATA BYTES s 256 128 C bytes R 259 131 260 132 CRC MSB MS 1 byte 261 133 CRC MSB LS CHAR 1 byte 262 134 CRC LSB MS CHAR 1 byte 263 135 CRC LSB LS CHAR 1 byte 264 136 ETX 1 byte Every data block will have either 128 or 256 bytes whichever is chosen If there is not sufficient data to fill a block it will be padded with space characters The algorithm used to calculate the CRC for each block is a modified CCITT CRC16 CRC is only calculated on the data bytes Heading B 7 details the algorithm and includes application notes for implementing the algorithm in both C and assembly language The Presentation deals with the high level format of the message The data bytes of the transmission blocks when collected together exhibit the following high level format 88 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS The preamble marks the beginning of a message Transmission Identification The ASCII character S marks the beginning of the transmission 8 XIaN3ddV TEST TYPE COUNT defines the number of tests that will be transmitted in this particular transmission Not all Test Types are sent in all
96. ined as indicated in the COULTER STKS with Reticulocyte Analysis manuals using the recommended reagents If the average room temperature should change more than 10 F from the calibrating temperature verify calibration and recalibrate if necessary to ensure conformance to specifications 29 59 2m 85 m 2 o2 Replicate CBC Precision of the CBC parameters is specified as a Coefficient of Variation CV based on at least 31 determinations of the same sample See Table 2 4237182A December 1993 37 SPECIFICATIONS CHARACTERISTICS Table 2 Replicate Precision CBC Parameters n gt 31 Parameter CV WBC at 10 0 x 10 cells uL 1 796 RBC at 5 00 x 10 cells uL 0 896 Hgb at 15 0 g dL 0 896 MCV at 90 0 fL 0 896 RDW at 13 096 2 296 Pit at 300 x 10 cells uL 3 396 Pit at 30 0 x 10 cells uL 6 696 Pit at 10 0 x 10 cells uL 10 096 MPV at 9 0 fL 2 296 Replicate Precision WBC Differential Precision of the WBC differential parameters is specified at 9596 confidence level based on at least 31 determinations of the same sample see Table 3 Table 3 Replicate Precision WBC Differential Parameters m Parameter 9596 og Confidence zt Limits lt LY at31 WBC at 4 0 10 cells uL 3 0 Do ST MO at8 WBC at 4 0 x 10 cells uL 2 0 a NE at 57 WBC at 4 0 x 10 cells uL 3 0 71 at3 WBC at 4 0 x 10 cells uL 1 0 at 1
97. is always 2 bytes The ASCII tag TS can repeat itself for as many tests as may be required 8 XIaN3ddV Message Definition The Host Worklist consists of the information about a number of blood samples each of which has a number of fields Internally the structure is the same as that used for the Active Worklist Most of these fields may be transmitted from the Host to the DMS Below is the list of possible fields their field width and the appropriate ASCII Tag to be used for transmission FIELDS CANNOT HAVE LEADING OR TRAILING SPACES MESSAGE WILL BE REJECTED 4237 182 December 1993 115 APPENDIX B APPENDIX B Cassette Number amp Position Field Tag Data Format Data Length 6 bytes maximum STKS DMS 1G1 SPECIFIC The 1G1 switch must be on otherwise this field will be ignored by the Host Worklist Identifier 1 Field Tag Data Format xIxIxIxIxIxIxIxIx x x x x x xx Data Length 16 bytes maximum STKS DMS 1G1 SPECIFIC The 1G1 switch must be on otherwise this field will be ignored by the Host Worklist Identifier 2 Field Tag Data Format Oil xI xIxIxIxIxIxIxIx x x x x x x x Data Length 16 bytes maximum Sequence Number Field Tag Data Format sin Data Length 6 bytes maximum Birth Date Field Tag Data Format efe Date Month Day Year example 12 31 1999 Data Length 10 bytes maximum 116 PN 4237182A
98. is an extremely accurate and effective method of positive patient identification Certain features such as checksum digits maximize accuracy in reading Codabar Code 39 and Interleaved 2 of 5 labels In one study the use of checksum digits detected 97 of misread errors Use checksums to provide protection against occasional misread errors caused by problems such as damaged or misapplied labels If you must use bar codes without checksums Coulter recommends that you verify each bar code reading to assure correct patient identification The algorithm for determining the checksum for each code is given below 9 XIGNdddV This code requires 3 to 11 data digits plus a checksum To determine the value of the checksum character 1 Identify even and odd positioned characters in the message with the right hand message character always defined as an even positioned character 2 Sum the numeric values of the odd positioned characters 3 Sum the numeric values of the even positioned characters and multiply the total by 3 4 Sum the odd and even totals from steps 2 and 3 5 Determine the smallest number which when added to the sum in step 4 results in a multiple of 10 This number is the value of the checksum character PN 4237182B March 1995 129 APPENDIX C 6 Determine whether total number of characters message plus checksum is odd or even If odd add a leading nonsignificant zero to the message to produc
99. is delivered to the mixing chamber to remove residual material from the previous cycle 10 mL of diluent rinse for the WBC bath comes from the RBC diluent dispenser and 6 mL of diluent rinse for the RBC bath comes from the WBC diluent dispenser The WBC bath needs a larger rinse volume to remove RBC cell stroma after lysing to remove remaining lytic reagent to rinse above the 7 mL fill line and to rinse the hemoglobin cuvette 3 4 SECONDARY OPERATING MODE IMPORTANT The blood detectors are not active in the Secondary mode Be sure to inspect the specimen for clots and use good laboratory practices to verify results v n 23 md m oO 2 The Secondary mode of operation is like the Primary mode except 1 You enter the sample identification number on the Diluter keypad before you run the sample 2 You introduce the sample at the aspirator tip and begin the cycle by pressing the panel behind the tip 3 150 uL of sample is aspirated for the CBC and CBC Diff modes After the sensing period the aspirator tip is backwashed 4 The blood detectors are not active in the Secondary mode 5 Yourun all samples in the Secondary mode 6 You never aspirate whole blood in the RETICS mode of sample analysis 4237182A December 1993 25 OPERATION PRINCIPLES Reticulocyte Analysis Reticulocyte samples are run in the special RETICS mode which is set at the Analyzer CRT The samples are prepared outsid
100. is or any other automated laboratory analyzer In the USA for Service call Coulter Customer Operations 1 800 526 7694 CONTENTS l fL ll l aI C C 1 USE AND FUNCTION 1 11 INTENDED USE 1 12 METHOD HISTORY 3 13 SYSTEM FUNCTION 5 Power Supply 6 Diluter 6 Analyzer 6 Data Management System DMS 6 Reagent Subsystem 7 Diluent 7 CBC Lytic Reagent 7 Diff Lytic Reagent 7 Leukocyte Preservative 7 Retic Reagents 8 Cleaning Agent 8 Control Material 8 Calibrator 8 14 OPTIONS 9 Auto Reporter 3 9 Graphic Printer 9 Laser Printer 9 Matrix Printer 9 Bar Code Wand 9 Sample Prep Kit 9 15 MATERIAL SAFETY DATA SHEETS MSDS 10 16 CLIA COMPLEXITY CATEGORY 10 2 INSTALLATION 11 2 1 GENERAL 11 2 2 SPECIAL REQUIREMENTS 11 Space and Accessibility 11 Electrical Input 12 Ambient Temperature and Humidity 12 Air Conditioning 12 Ventilation 12 Drainage 13 PN 42371828 March 1995 CONTENTS 2 5 INTERUNIT CONNECTIONS 13 3 OPERATION PRINCIPLES 17 3 1 3 2 3 3 3 4 3 5 3 6 3 7 3 8 GENERAL 17 COULTER METHOD 17 PRIMARY OPERATING MODE 18 Operating Cycle 18 Transport 18 Aspiration 19 Delivery 19 CBC Sensing System 21 CBC Analysis in the Baths 21 Differential Multiparameter Sensing System 22 WBC Differential Analysis 24 Backwash and Rinse 25 SECONDARY OPERATING MODE 25 Reticulocyte Analysis 26 COUNTING AND SIZING 26
101. l 8 XIIN3ddV C Histogram Field Tag Sep Data Format lt weas ee Data Length 512 bytes typical S Histogram Field Tag Sep Data Format El eros gt a Data Length 512 bytes typical 4237182A December 1993 107 APPENDIX B APPENDIX B DIFF Latex Parameter Group Fields Each field in the DIFF Latex Parameter Group has the following format Tag Sep Data Format LJ xIxIxiIx xIxIxIx x 5 char numeric data max 1 char space separator min 3 char flag data max Tags PRIMER MN MN 5 CV CV 5 CV Numeric Data If the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following 2 2 Incomplete Computation Flow cell clogged RETIC Latex Parameter Group Fields Each field in the RETIC Latex Parameter Group has the following format Tag Sep Data Format I xIxIxiIx xIxIxIx x 5 char numeric data max 1 char space separator min 3 char flag data max Tags PRIMER MN MN 5 MN 108 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS CV 5 Numeric Data I the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following Lee Incomplete Computation Flow cell clogged Control Information Group Field Tag Sep Data Format
102. l difference between the averages of the two modes do not exceed the following limits WBC 0 4 x 10 cells pL or 596 whichever is greater RBC 0 2 x 10 cells uL or 296 whichever is greater Hgb 0 3 g dL or 296 whichever is greater Plt 20 x 10 cells pL or 7 whichever is greater 987 29 59 2m 85 m 2 o2 O Data collected using blind paired samples has demonstrated that variability observed in the paired samples between Primary and Secondary modes is similar to the variability observed within a mode PN 4237182B March 1995 43 SPECIFICATIONS CHARACTERISTICS 4 3 PERFORMANCE CHARACTERISTICS The CBC WBC differential and Reticulocyte performance characteristics described in this section were analyzed on the COULTER STKS with Reticulocyte Analysis using the recommended reagents Daily Startup shutdown calibration and control procedures were performed according to recommendations by Coulter Corporation Data collection and verification of claims was performed using the following K EDTA anticoagulated whole blood specimens Air displacement pipettors for off line Reticulocyte sample preparation The morphologically and distributionally abnormal specimen types used in the paired sample accuracy and precision studies are presented in Table 19 Precision Replicate Precision of the CBC Parameters The results of replicate precision testing n 31 for each parameter measured by the ST
103. ler must be enabled Compatibility The STKS DMS 2A supports the Host High Level Communication Protocol similar to that supported in STKS DMS 1G1 and MAXM 1G1 plus Retics if and only if the compatibility switch is set to one of these modes 4237182A December 1993 85 APPENDIX B AP PENDIX B Graphics Data Enable From the communication definition setup screen the operator can enable or disable the following graphic items Scatterplots DF1 DF2 DF3 VCS histograms Scatterplots DF5 DF6 VCS histograms RBC histogram Plt histogram B 4 DMS TO HOST COMMUNICATIONS Datalink Protocol All transmitted bytes are ASCII characters All numeric values are hexadecimal Hence for example the number FF hex is represented by the two ASCII bytes FF 46H 46H The first two bytes of the transmission are the number of blocks to be sent followed by transmission of data blocks see format below The final block is padded with ASCII spaces 20H to fill a whole block No NULL 00H characters are transmitted Please note that the blocks will be padded by ASCII SP 20H if data does not fill the whole block The DMS supports a full handshake and a no handshake protocol Full Handshake The DMS sends the following control characters plus data and expects the indicated host response 86 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS
104. method The STKS requires the use of a diluent to disperse the erythrocytes leukocytes and thrombocytes in the blood sample sufficiently to minimize the possibility of an aperture orifice being occupied by more than one cell at a time The system corrects for cell coincidence automatically Since cell size volume is measured the effect of the diluent on osmosis or other phenomena must be tightly controlled Also the diluent must not contain particles nor must it support growth of bacteria or molds The hemoglobinometry process requires the conversion of hemoglobin to a stable pigment This is done by a lytic reagent The lytic reagent converts a substantial portion of the hemoglobin released by hemolysis to a stable cyanide containing pigment the absorbance of which is directly proportional to the hemoglobin concentration of the sample The accuracy of this method equals that of the hemiglobin cyanide method the reference method of choice for hemoglobinometry recommended by the International Committee for Standardization in Hematology 4 PN 4237182A December 1993 METHOD HISTORY The WBC differential technology has been established in the COULTER VCS Analysis and classification of white blood cells are based on the Coulter method of leukocyte differential counting using three measurements individual cell volume V high frequency conductivity C and laser light scatter S The WBC differential method stems from the
105. n considered together with Hct and Hgb measurements 4237182A December 1993 USE AND FUNCTION The COULTER COUNTER Model S was the first instrument that automated simultaneous multiparameter measurements on blood Brittin et al Gottmann and Hamilton and Davidson reviewed the performance and clinical values of the Model 5777 Refinements of the COULTER COUNTER analyzer to provide accurate size volume distribution data led to a reawakening of the interest in pathological erythrocyte size distribution first aroused by Price Jones in 1922 67 lt o z Among the advantages offered by the Coulter method of counting and sizing was the ability to derive an accurate Hct measurement by summing the electronic volume of erythrocytes England et al speculated that electronic Hct measurements did not have the trapped plasma of centrifugal Hct measurements Bull et al described the use of a COULTER COUNTER analyzer for counting thrombocytes This method useful as it was depended on preparing thrombocyte rich plasma to avoid counting erythrocytes as thrombocytes Mundschenk et al and Schulz and Thom indicated the possibility of counting thrombocytes in the presence of erythrocytes and classifying them by 2 Electronic refinements in the Model S PLUS enhanced the accuracy of this hydrodynamic method Von Behrens and Paulus also indicated the feasibility of thrombocyte counting by the Coulter
106. ofile Field Tag Data Format Data Length 1 byte maximum Note Profile can be between 1 and 9 If 1G1 compatibility switch is set this value defaults to profile 1 Entry Date Field Tag Data Format Date Month Day Year example 12 31 99 Data Length 8 bytes maximum Entry Time Field Tag Data Format Time Hour Minute example 20 59 8 XIIN3ddV Data Length 5 bytes maximum Test Field Tag Data Format Data Length 64 bytes maximum STKS DMS 2A SPECIFIC The 1G1 switch must be off otherwise this field will be ignored by the Host Worklist This is a new field introduced in STKS DMS 2A to indicate a test type The host may transmit as many as three test types such as CBC DIFE RETIC with the same tag TS in any order This special field can also handle the ID1 and the CP for that particular test Example TEST ID1 Cass pos the commas are required as separators The following shows the possibilities of the data format for RETIC 4237 182 December 1993 119 APPENDIX B APPENDIX B RETIC Invalid ID1 or Cass pos not given RETIC CASS POS 101 not given RETIC OK CASS POS not given RETIC ID1 CASS POS OK Both are specified The sample will be rejected if any of the commas or the test type or a positive identifier is missing Sample Mode Field Tag Data Format Space Data Values Primary 5 Secondary Data Length 1 byte maximum SAMPLE MODE T
107. omputer then derives the Plt count for each aperture from the portion of the histograms between the minimum points Then the computer votes on the Plt count MPV and PDW derived from the raw data This is an approximate value since comparison is made based on raw data prior to multiplication by the calibration factor 4237182A December 1993 29 OPERATION PRINCIPLES Derived and Computed CBC Parameters The Analyzer computer derives MCV and RDW from the RBC histogram and MPV and Plt count from the Plt histogram It computes Hct MCH and These results sent to the DMS 3 6 MEASUREMENT OF HEMOGLOBIN CONCENTRATION After the WBC count the lysed WBC dilution drains into the hemoglobin cuvette for Hgb measurement A beam of white light from an incandescent lamp goes through the cuvette and then through an optical filter that has a center transmission wavelength of 525 nm Light passing through the filter falls on a photocell The photocurrent thus generated is proportional to the transmittance of the contents of the cuvette at the chosen wavelength It is sent to the Input Output Calibration VO CAL card where it is digitized The digital information is sent to the Analyzer computer then the DMS and then the Printer A significant refinement in the COULTER COUNTER systems is the introduction of a reagent blank into the cuvette during each operating cycle After the percent transmittance is converted to absorbanc
108. or its documentation including quality performance merchantability or fitness for a particular purpose No Liability for Consequential Damages In no event shall Coulter or its suppliers be liable for any damages whatsoever including without limitation damages for loss of profits business interruption loss of information or other pecuniary loss arising out of the use of or inability to use the COULTER Product software Because some states do not allow the exclusion or limitation of liability for consequential damages the above limitation might not apply to you General This agreement constitutes the entire agreement between you and Coulter and supersedes any prior agreement concerning this Product software It shall not be modified except by written agreement dated subsequent to the date of this agreement signed by an authorized Coulter representative Coulter is not bound by any provision of any purchase order receipt acceptance confirmation correspondence or otherwise unless Coulter specifically agrees to the provision in writing This agreement is governed by the laws of the State of Florida a COULTER REVISION STATUS Issue 12 93 Software version 2A Issue B 3 95 Software version 2B Change pages cover inside front cover i viii 5 9 10 42 81 129 151 152 154 163 164 trademarks and back cover Note Changes that are part of the most recent revision are indicated in text by a black ba
109. ormation is sent to the Data Memory DATA MEM card where the pulse heights are stored That is the digital information from each aperture is stored according to volume in 256 channel size distribution histograms After the sensing periods are completed the size distribution histograms are sent through the Power Supply Monitor Buffer PS MON 2 card to the Analyzer computer Using a system of moving averages the computer smooths the RBC histogram To ensure that the size distribution curve accurately reflects the true cell population RBC sensing is extended for not more than four additional 2 second sensing periods whenever the RBC data accumulations are below a predetermined value The RBC size distribution curve reflects the total data accumulated in all of the sensing periods 28 PN 4237182A December 1993 COUNTING AND SIZING Pit Count and Size Distribution Pit Fitting Process In the Platelet Processor PLAT PROC card pulses representing cells from 2 to 20 fL are classified as Plts To ensure that the Plt count and size distribution curve accurately reflect the cell population Plt sensing is extended for not more than four additional 4 second sensing periods whenever the Plt data accumulation is below a predetermined value When sensing time is extended the Plt count is divided by the number of sensing periods the Plt size distribution curve reflects the total of data accumulated in all of the sensing periods The Plt pulses
110. r DMS Digiboard accepts or rejects the entire transmission at the Data Link level DMS Digiboard then transmits a DLE character followed by a single ASCII character indicating whether the transmission is accepted or rejected at the presentation level The ASCII character following the DLE may be one of the following Transmission Accepted Ready for next Transmission Accepted DO NOT send more B Transmission Rejected Please retry Transmission Rejected Please abandon D 112 PN 4237182A December 1993 SEND ENO of data blocks 2 bytes gt HOST ready HOST TO DMS COMMUNICATIONS The following demonstrates the above protocol send data blocks ENO Data Block for each bl all done ock bed ted ted ted ted RECEIVER DMS ENO go ahead or SYN busy ACK read to receive or NAK receiver abort ACK block received ok or NAK retransmit this block or ENQ retransmit all blocks ACK transmission except or NAK transmission reject Presentation Level Response DLE transmission accept ready for next or B transmission accept do NOT send more OF C transmission reject retry Or D transmission reject abandon ted 8 XIaN3ddV 4237182A December 1993 113 APPENDIX B APPENDIX B Data Block Structure
111. r erythrocyte Volume Corpuscular erythrocyte Hemoglobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte volume Distribution Width Plt Platelet or thrombocyte count MPV Mean Platelet thrombocyte Volume LY Lymphocyte percent LY Lymphocyte number MO Monocyte percent Monocyte number Neutrophil percent NE Neutrophil number EO Eosinophil percent EO Eosinophil number BA Basophil percent BA Basophil number RET Reticulocyte percent Reticulocyte number 2 PN 4237182A December 1993 INTENDED USE Packed cell volume PCV is the reference method for Hct values PCV is defined as the volume percentage of erythrocytes in whole blood obtained by centrifuging the blood Hct is defined as the relative volume of erythrocytes in whole blood as determined using the Coulter method of counting and sizing or any other cell by cell volume measuring system that does not rely on centrifugation mc co sm 12 oo The STKS also derives Plateletcrit Pct and Platelet Distribution Width PDW These parameters are not intended for diagnostic use however the value for PDW is used as an internal check on the reported platelet parameters Plt and MPV The purpose of the STKS is to separate the normal patient with all normal system generated parameters from the patient who needs additional studies of any of these parameters These studies
112. r a PCL5 compatible laser printer select PCL5 Matrix Printer This Printer prints the data displayed on the DMS screen including parameter data and graphics For an EPSON LQ compatible matrix printer select EPSON LQ Bar Code Wand This wand scans 5C cell control data from the assay sheet and enters it in the setup file Sample Prep Kit This kit includes pipettors for the 50 pL and 2 pL dilution steps in the retic procedure Pipette tips test tubes and a test tube rack are also included PN 4237182B March 1995 9 USE AND FUNCTION 1 5 MATERIAL SAFETY DATA SHEETS MSDS To obtain an MSDS for reagents used on the STKS 1 Inthe USA send a written request to Z lt o z Coulter Corporation Attn MSDS Requests P O Box 169015 Miami FL 33116 9015 2 Outside the USA contact your local Coulter Representative 1 6 CLIA COMPLEXITY CATEGORY For the purposes of implementing CLIA Test Categorization 42 CFR 493 17 the COULTER STKS Analyzer with Reticulocyte Analysis has been assessed for its CLIA complexity category The Centers for Disease Control and Prevention CDC and the Food and Drug Administration FDA in a joint review have determined the complexity category for the COULTER STKS Analyzer with Reticulocyte Analysis as MODERATE CDC Analyte identifier code 5506 and test system identifier code 10093 10 PN 4237182B March 1995 INSTALLATION 2 2 1 GENERA
113. r in the margin PN 4237182B March 1995 PN 4237182B March 1995 TRADEMARKS U lvl la AccuComp ACCUVETTE ACCU ZYME AQUA AD AUTO CAL AUTO CLONE CARDS CASH CC logo CHANNELYZER CHEMOTERGE COMPLETE CELL ANALYSIS COSINE COULTER COULTER CHEMISTRY COULTER CLENZ COULTER CLONE THE COULTER COUNTDOWN COULTER COUNTER COULTER CURRENTS COULTERAMA Cyto Spheres CYTO STAT CYTO TROL C ZYME DACAL DACOS DACOS logo DART DIFF3 DIFF3 50 DIFF4 DILU PACK E A SY 1 EASY 88 EASY 2 EPICS FASTECS 5C 4C HEMO CAL HEMOTERGE HEMO W IsoFlow ISOLYSE ISOPET ISOTERGE ISOTON LANGLEY FORD LANGLEY FORD INSTRUMENTS LEASE PAK LFI logo LYSE S MDADS MINI KEM NANO SIZER OMNISORP OptiChem S CAL SOMACOUNT SOMAFIX SOMATON STAIN RIGHT THROMBOCOUNTER THROMBO FUGE U V ZYME ZAP OGLOBIN ZAPONIN and ZETAFUGE are trademarks of Coulter Corporation 3 21 95 Code 39 is a registered trademark of Interface Mechanisms Inc AIM is a registered trademark of Automatic Identification Manufacturers Inc HEMOGARD is a trademark of Becton Dickinson amp Co PN 4237182B March 1995 GO COULTER STKS with Reticulocyte Analysis DOCUMENTATION m Reference PN 4237182 White binding Special Procedures and Troubleshooting PN 4237187 Silver binding Operator s Guide PN 4237188 Clear binding Master Index PN 4237191 Copyright Coulter Corporation 1993 1995 Righ
114. racy is the sum of the variables of linearity and precision for the test and the comparator method using specimens covering the reportable range The comparator method for reticulocyte counting is the reference method described in the NCCLS document H16 P n 4000 or its pertinent successor document Analysis is based on the differences diff Run 2 instrument Reference The limits over the clinical range for a minimum of 50 specimens from a general hospital population of no more than 30 specimens with abnormally elevated reticulocyte values Retic gt 4 are as follows Retic Mean Difference SD of Difference 0 00 15 00 1 0 lt 1 5 Both requirements must be met The limits over the clinical range for a minimum of 50 specimens with the following characteristics are as described below greater than 50 abnormally elevated values elevated Retic values Retic gt 4 no greater than 5 of 50 specimens have Retic values gt 20 Retic 96 Mean Difference SD of Difference 0 00 30 00 1 5 lt 3 0 Both requirements must met CBC Linearity 7 79 m 9 1 gt a e z o When tested using dilutions made from a specimen having no interfering substances and a typical MCH of 30 pg the STKS value is equal to the expected value within the limits given in Table 7 To obtain the same results multiple readings must be taken at each point to eliminate the statistical effects of imprecision
115. rameter Group has the following format Tag Sep Data Format LJ xIxIxiIx xIxIxIx X 5 char numeric data max 1 char space separator min 3 char flag data max Tags WBC HGB 4237182A December 1993 95 APPENDIX B APPENDIX B MCHC RDW PCT MPV PDW Numeric Data If the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following Total Voteout Count Exceeds Maximum Goths 2 Incomplete Computation Flag Data The three flag data characters can be R H E or defined as parameter affected by other parameter review parameter exceeds high laboratory set patient high action limit exceeds low laboratory set patient low action limit edited result Reference Operators Guide Diff Count Parameter Group Fields Each field in the DIFF Count Parameter Group has the following format Tag Sep Data Format 5 char numeric data max 1 char space separator min 3 char flag data max Tags NEZ EOZ 96 PN 4237182A December 1993 DMS T0 HOST COMMUNICATIONS Numeric Data If the numeric data of each format e g xx xx does not contain a decimal number then it contains one of the following DIFF Percent Parameter Group Fields Each fi
116. rash L Rheinschmidt M Lieu S Meers P and Brew E Fluorescence activated Flow Cytometry in the Haematology Clinical Laboratory Cytometry Supplement 3 60 1989 24 Friedman E W Reticulocyte Counts How to Use Them What They Mean Diagnostic Medicine 29 33 July 1984 25 Williams W J Beutler E B Erslev A J and Lichtman M A Hematology Third Ed 265 1972 26 Brecher G New Methylene Blue as a Reticulocyte Stain Am J Clin Path 19 895 1949 158 PN 4237182B March 1995 REFERENCES 27 Eckhoff RF An experimental indication of the volume proportional response of the Coulter Counter for irregularly shaped particles J Sci Inst 1967 44 648 649 28 Grover NB Naaman J Ben asson S and Dojanski F Electrical sizing of particles in suspension Ill Rigid spheroids and red blood cells Biophys J 1972 12 1099 1116 29 Waterman CS Atkinson EE Wilkins B Fischer CL and Kimsey SL Improved measurement of erythrocyte volume distribution by aperture counter signal analysis Clin Chem 1975 21 1201 1211 30 Kachel V and Ruhenstroth Bauer G Methodik and Ergebissne Optiseher Formfatorunter suchungen bei der Zellvolumenmessung nach Coulter Micros Acta 1976 75 419 423 31 Bull BS and Elashoff RM et al 1974 A study of various estimators for the derivation of quality control procedures from patient erythocytic indices Am J Clin Path 61 4 475 32 Koepke JA Tips on technology MLO 15 198
117. ration has complied with the requirements governing the use and application of a laser as stipulated in regulatory documents issued by the U S Department of Health and Human Services and the Center for Devices and Radiological Health CDRH In compliance with these regulatory documents every measure has been taken to ensure the health and safety of users and laboratory personnel from the possible dangers of laser use IV gt 20 Nm gt O 2 gt oc z o 4237182A December 1993 55 PRECAUTIONS HAZARDS WARNING This instrument contains components dangerous to the operator If any attempt has been made to defeat a safety feature or if this instrument fails to perform as listed in this manual disconnect power and call your Coulter Service Representative CDRH approved labels are placed near or on those covers that when removed might expose laser radiation Figure 10 shows the laser cover open and the protective housing off This illustration is intended only to show you what the system looks like in compliance with CDRH See Figure 10 for the label and its location on the laser head See Figure 11 for the label location on the beam cover between the laser head and the sampling compartment Figure 10 and Figure 12 show certification labels Eg mc z E o lt lt lt
118. rol PN 7547001 three levels in pierceable tubes monitors both the CBC and differential parameters 4C PLUS cell control PN 7546771 three levels in pierceable tubes monitors the CBC parameters e LATRON primer PN 7546915 used immediately prior to running the LATRON control prepares the tubing and components for the control process LATRON control PN 7546914 monitors the performance of the volume conductivity and light scatter measurements Retic C cell control PN 7546979 monitors the performance of the reticulocyte parameters Calibrator The S CAL kit PN 7546808 is an acceptable alternative to the whole blood reference method for calibrating the CBC parameters Before using the S CAL kit read the instructions provided with the kits package insert 8 PN 4237182A December 1993 SYSTEM FUNCTION The differential measurement devices are set for optimum performance at the factory 1 4 OPTIONS co sm 22 oo Auto Reporter 3 This Printer prints parameter data on HEMATOLOGY report forms It has a bar code reader that matches the bar codes on the report forms to the bar codes stored with the data files in the DMS This Printer does not print Retic results Graphic Printer This Printer prints the data displayed on the DMS screen including parameter data and graphics Laser Printer This Printer prints the data displayed on the DMS screen including parameter data and graphics Fo
119. rom No default to Yes and if AutoTransmit is turned on a Partial Aspiration or No Read condition prompts the system to transmit the following information to the host computer all sample information e identifiers Partial Aspiration or No Read message and e dots for parameter results An alternative transmission specification is also available upon request from Coulter Customer Operations STKS Revision 1G 1 Retics which adds only the retic parameter including Date Time and IDs to the basic CBC Diff transmission QC data collated profiles and additional items listed above are NOT included in this specification IMPORTANT The COULTER STKS utilizes fail safe sample management The unique fail safe features prevent data transmission to the host computer when specific status messages appear on the DMS When the sample status is NO MATCH NO READ or PARTIAL ASPIRATION samples will not be AUTOMATICALLY transmitted to the host computer in the sequence run Nor will they be automatically printed in the sequence run Sequence dependent computer systems can compromise fail safe sample reporting PN 4237182B March 1995 81 8 XIaN3ddV APPENDIX B APPENDIX B This information is intended for software engineers who need to maintain or modify the operation of the STKS DMS Host communication When the DMS receives data from the STKS Analyzer it can automatically transfer that data to a host computer T
120. s It incorporates complete blood count CBC WBC differential and Reticulocyte analysis If your system does not include Reticulocyte Analysis disregard the references to it nc co 2m 22 oo Reticulocyte Retic analysis on the COULTER STKS uses New Methylene Blue NMB for the quantitative enumeration of reticulocytes from human whole blood It is intended for in vitro diagnostic use with STKS instrumentation using volume conductivity and light scatter VCS technology ANALYZER lI DILUTER 7182019A POWER SUPPLY Figure 1 COULTER STKS This system has two operating modes Primary and Secondary In the Primary mode as many as 144 tubes with pierceable caps are loaded into cassettes and presented automatically to the system The Primary mode is equipped with a bar code reader In the Secondary mode open vials are presented manually to the aspirator tip 4237182A December 1993 USE AND FUNCTION This system determines the following hematologic parameter values WBC White Blood Cell or leukocyte count z z 2 RBC Red Blood Cell or erythrocyte count 5 Hgb Hemoglobin concentration Hct Hematocrit relative volume of erythrocytes MCV Mean Corpuscula
121. scatterplot development 30 scatterplot review DF 2 Scatterplot 31 DF 3 Scatterplot 31 DF 5 Scatterplot 31 DF 6 scatterplot 31 secondary operating mode 25 special requirements 11 StabiLyse 7 sweep flow 27 system function 5 Analyzer 6 Data Management System DMS 6 Diluter 6 Power Supply 6 reagent subsystem 7 ticket specifications for Auto Reporter 3 139 transmission to a host computer 81 transport system 20 Triple Transducer Module 22 24 voting 27 X analysis in the DMS 31 adjusting initial XB target values 33 PN 4237182B March 1995 1 65 INDEX 166 PN 4237182B March 1995 LIMITED WARRANTY This instrument when purchased from Coulter Corporation or from an authorized distributor or subsidiary company is warranted against defects in materials and workmanship for a period of one 1 year from date of the original invoice to the customer for this instrument or for longer periods if purchased This warranty is limited to the repair and replacement of parts which prove to be defective during the warranty period This warranty is not valid for parts damaged lost or which fail because of accident fire theft acts of nature storms floods etc negligence of the use of chemicals which have a deleterious effect This warranty is conditioned upon Coulter Corporation retaining the unqualified option of replacing parts up to and including an entire instrument This warranty will not e
122. st leave at least a 1 8 window for viewing the contents ofthe tube The maximum label width for a 10 mm diameter tube is 1 1 The minimum label width is 0 400 Table 30 Code Related Specifications Code 128 Code re Codabar Code 3 Fer USS 128 Narrow element NE 0 0105 0 010 0 0105 0 010 0 001 width 0 001 Scaling 0 001 Factor 1 538 Wide element narrow 2 2 to 3 1 N A 2 21 to 3 1 2 2 to 3 1 2 to 4 1 element ratio WE NE Intercharactergap 0 010 gt 0 010 Min No Data digits 3 to 11 3 to 9 3 to 9 3to9 3 to 11 Checksum 8 to 8 with always printed HEMOGARD 8 to 9 for AUTO tubes REPORTER 3 According to American National Standard for bar code specifications that yield 10 characters per inch at NE 0 0065 Code 128 is character dependent See AIM Uniform Symbol Specification Rev 1986 for additional required dimensional tolerances You must use and print a checksum character and it must conform to the AIM USS 128 checksum generation procedure Do not use these values Code set A 0 64 through 102 Code set B 0 95 through 102 Code set C 100 through 102 RK Do not use leading or trailing spaces in the ID 128 PN 4237182A December 1993 CHECKSUM ALGORITHM 6 8 CHECKSUM ALGORITHM Interleaved 2 of 5 Coulter strongly recommends the use of bar code checksums to provide automatic checks for read accuracy IMPORTANT Use of bar codes
123. structural characteristics of each cell 4237182A December 1993 17 OPERATION PRINCIPLES ReticPrep NMB is a two step method that prepares whole blood samples for reticulocyte analysis A supravital dye New Methylene Blue is incubated with whole blood samples The dye precipitates to the basophilic RNA network found in reticulocytes Hemoglobin and unbound stain are removed by adding a clearing reagent leaving clear spherical mature RBCs and darkly stained reticulocytes Stained reticulocytes are differentiated from mature red cells and other cell populations by light scatter direct current measurements and opacity characteristics when using the STKS with volume conductivity light scatter and reticulocyte counting technology 3 3 PRIMARY OPERATING MODE The Primary operating mode is for CBC and differential parameters only Operating Cycle Samples in the loading bay are automatically transported mixed aspirated and analyzed Sample tubes which can be identified by bar code labels are loaded into 12 tube cassettes Cassettes and the tube position in the cassettes are also identified by bar code labels You can load up to 144 samples into the STKS at one time Figure 5 illustrates the loading bay filled with cassettes u Fa lt cc ac Press PRIME APERT then cycle a normal whole blood in the Primary mode to prime the system Place cassettes in the right stack then press START CONT
124. t NE x WBC 100 3 u L n x WBC 100 MO x WBC 100 0 x WBC 100 BA x WBC 100 10 10 ES Ls NC NN wa wa CNET 10 10 E 10 EN NUN 10 EINE 10 10 0 1000 p E HCT x 10 HGB x 10 RBC 0 0 0 06 BEE oa EM PS o o EL uE rear eee uL uL uL 0 07 1 100 1000 10 Parameter for Investigational Use Only Calculation formula commonly used in laboratories for these red cell indices When the internal value is greater than the displayed format the value will be displayed with one less decimal place Display Format 999 9 999 9 999 9 999 9 999 9 999 9 999 9 999 9 999 9 999 9 999 9 99 99 999 9 999 9 999 9 999 9 999 9 999 9 99999 999 9 9 999 999 9 99 99 999 9 150 PN 4237182A December 1993 REPORTING UNITS Table 33 5 1 1 and S l 5 Format Reporting Units Factor Label Format wsc 10 ton 9999 NE 10 9999 LY ERBE 999 9 MO 1 999 9 EO e 999 9 BA FO ss EM 999 9 NE NE xWBC 100 10 10 999 9 LY ETE 100 10 107L 999 9 MO xWBC 100 10 10 999 9 EO 22 100 10 107L 999 9 BA 100 10 10 9999 MEE RET RET x RBC 100 kar Su 9999 Parameter for Investigational Use Only For S I 5 format f Calculation formula commonly us
125. t values by more than 3 and the CV should be less than 1 596 If the CVs are less than 1 596 and the means are less than 396 different from the target values use the calculated means as new target values If the CVs are greater than 1 596 or the mean values are greater than 396 different from the recommended target values there may be an instrument or population problem In this case repeat this procedure Use average operating conditions to establish X target values to fit your laboratory s population 4237182A December 1993 33 OPERATION PRINCIPLES using the next 20 X batches If the indices themselves are stable in a hospital population then any deviation from the TARGET VALUES and ACTION LIMITS may point to an instrument or reagent problem These problems would involve the parameters directly measured by the instrument and used to calculate the red cell indices Table 1 lists the directly measured parameters that would be involved with out of limits X batch values for each of the red cell indices If the X indices are still out of limits you should investigate the instrument and reagent systems associated with the directly measured parameter s as indicated by Table 1 and call your Coulter Service Representative Table 1 Effect of Directly Measured Parameters on the Red Cell Indices Directly Measured Parameter MCV RBC HGB LOW LOW LOW LO See the Glossary for terms used with the X Analysis
126. ternally Regulated Pressure 60 psi pounds per square inch mi z o FE ul lt lt Vacuum 22 in Hg inches of mercury at sea level Calibration Stability Electronic measurement system lt 1 per month Variation with temperature If ambient room temperature changes by less than 10 F from the calibrating temperature and the temperature is within the temperature specifications then the STKS does not require calibration Under these conditions the calibration factor difference is 36 PN 4237182A December 1993 DMS Storage PHYSICAL SPECIFICATIONS WBC lt 1 25 RBC lt 0 70 Heb lt 0 78 MCV lt 1 18 Plt lt 2 70 MPV lt 5 00 Patient results 5 000 sets including all Sample Analysis screen displays Patient Sample sort capacity 1 000 sets Controls 30 files 100 runs file 4 2 PERFORMANCE SPECIFICATIONS Precision The STKS consists of three subsystems which we have designated as CBC Complete Blood Count WBC Differential and Retics The CBC subsystem is based on the established Coulter principles of automated cell counting The WBC differential subsystem is based on the Coulter principles of leukocyte differential counting as embodied in the COULTER VCS The Retics subsystem is based on the Coulter volume conductivity and light scatter technology Performance specifications stated apply only to an instrument that has been properly mainta
127. tes Erythrocyte inclusions stained by New Methylene Blue if sufficiently numerous within a sample and some hemoglobinopathies SS SC might affect the accuracy of the reticulocyte enumeration 54 PN 4237182A December 1993 PRECAUTIONS HAZARDS 5 9 1 SAFETY PRECAUTIONS 5 2 RADIATION HAZARDS WARNING Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure The Triple Transducer Module contains a laser The laser is a unique light source that exhibits characteristics different from conventional light sources The safe use of the laser depends upon familiarity with the instrument and the properties of coherent intense beams of light The beam can cause eye damage and instrument damage There is enough power from the laser to ignite substances placed in the beam path even at some distance The beam might also cause damage if contacted indirectly from reflective surfaces specular reflection The laser on the STKS is covered by a protective housing that is held in place by tamper proof screws WARNING Do not attempt to remove the laser or to open it If removal is required it must be done only by a Coulter Representative All service and maintenance of the laser must be done at the Coulter factory by trained personnel If removal is required it must be done by a Coulter Representative In the design and manufacture of the STKS Coulter Corpo
128. this agreement This is a license agreement and not an agreement for sale Coulter hereby licenses this Software to you under the following terms and conditions You May l Use this software in the computer supplied to you by Coulter 2 Maintain one copy of this software for backup purposes the backup copy shall be supplied by Coulter 3 After written notification to Coulter transfer the entire Product to another person or entity provided you retain no copies of the Product software and the transferee agrees to the terms of this license agreement You May Not l Use copy or transfer copies of this Software except as provided in this license agreement 2 Alter merge modify or adapt this Software in any way including disassembling or decompiling 3 Loan rent lease or sublicense this Software or any copy Limited Warranty Coulter warrants that the software will substantially conform to the published specifications for the Product in which it is contained provided that it is used on the computer hardware and in the operating system environment for which it was designed Should the media on which your software arrives prove defective Coulter will replace said media free of charge within 90 days of delivery of the Product This is your sole remedy for any breech of warranty for this software Except as specifically noted above Coulter makes no warranty or representation either expressed or implied with respect to this software
129. tions at 1 2 in or below Glue line must not cross the perforation line Edge of action paper copies must not roll up 144 PN 4237182A December 1993 APPENDIX E BAR CODE WAND E 1 DESCRIPTION The optional Hewlett Packard Smart Wand HBCR 8200 CC 2016513 is a bar code reader that fits into the wand case It consists of optical sensor digitizing electronics e a decode microprocessor output line driver The wand case is made of a polycarbonate material with e O ring seals at each end abend and strain relief for the cord e a sealed sapphire tip The required wand interface and power supply CC 2016512 provides the power and communication logic to interface to the DMS The interface connection is to the P4 communication port from the Digiboard Communication Processor assembly This connection also requires interface software on the DMS to integrate the two products EB ECT The typical wand characteristics are defined below Parameter HBCR 8200 Smart Wand Nominal Narrow Element width 0 0075 in Wavelength 655 nm Scan speed 3 to 50 in per second Tilt angle 0 to 45 Minimum contrast 4596 Operating temperature 20 to 70 C 4 to 158 F Humidity 5 to 9596 non condensing Shock 500 g s at 1 ms Ambient light 0 to 100 kLux direct sunlight Symbology supported Code 128 with checksum 4237182A December 1993 145 APPENDIX E APPENDIX E E 2 HOW TO SCAN A BAR COD
130. ts Reserved Printed on Recycled Paper Use and Function Installation Operation Principles Specifications Precautions Hazards Appendices References Glossary General Procedures Calibration Cleaning Procedures Replace Adjust Procedures Troubleshooting Controls and Indicators Startup Sample Analysis Data Analysis Shutdown Analyzer CRT Functions DMS Basics Sample Analysis Display Worklist Data Base Controls Apendices Combined index for the Operators Guide Special Procedures and Troubleshooting and Reference manuals COULTER SCIENCE SERVING HUMANITY COULTER CORPORATION Miami Florida 33196
131. xtend to any repairs or modifications made to the instrument by some party other than Coulter Corporation or a party authorized to do so by Coulter Corporation Also this warranty shall be effective only upon written notice of the defect to Coulter Corporation or its authorized distributor within five 5 days after occurrence of said defect This warranty shall apply only to use of the instrument at a location within a state of the United States and in Canada and shall not apply to use of the instrument at a location outside the continental limits of the United States including any territory possession military or government facility therein and in any other Country foreign to the United States Upon request of the purchaser Coulter Corporation can undertake to arrange for special warranty service upon agreed written terms only at a location where this warranty does not apply No other warranty of any kind is made expressed or implied COULTER SCIENCE SERVING HUMANITY COULTER CORPORATION Miami Florida 33196 COULTER CORPORATION CUSTOMER END USER LICENSE AGREEMENT This Product contains software that is owned by Coulter Corporation or its suppliers and is protected by United States and international copyright laws and international trade provisions You must treat the software contained in this Product like any other copyrighted material This license and your right to use the Product terminate automatically if you violate any part of

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