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OPTI™ CCA-TS Analyzer Operator`s Manual

1. Material mean Lot 1 Lot 2 Lot 3 OPTI CHECK Swr ST Swr ST Swr ST aqueous control solution Level 1 68 1 73 1 73 2 49 2 87 1 02 1 23 Level 2 42 0 44 0 51 1 11 1 20 0 45 0 59 Level 3 23 0 91 0 93 2 08 2 36 0 91 0 92 Whole Blood Within Run precision in whole blood samples was evaluated at three different PCO concentrations using multiple instruments and multiple cassette lots PCO in Whole Blood Level 1 Level 2 Level 3 Average 78 6 39 3 17 0 St Dev 1 8 1 7 1 8 DCH 2 3 4 4 10 6 n 18 18 18 Linearity The linearity of the dry PCO sensor was established using whole blood samples tonometered with different gas mixtures of known gravimetric compositon The reference PCO values of the tonometered blood samples were calculated from the gas composition using the following equation PCO Barometric Pressure 47 CO Linearity of Whole Blood Samples Correlation Slope Intercept Coefficient Sy x Range n 0 97 2 26 0 992 3 82 7 205 177 Operator s Manual OPTI CCA TS PCO2 B 3 PCO Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS vs other PCO Instruments on whole blood in a typical setting PCO analysis of heparinized whole blood samples was performed at multiple clinical sites Samples were analyzed on the OPTI CCA TS in parallel with laboratory instrumentation operated by hospital personnel and controlled following the hospital s estab
2. ere A 1 Opsraurig RE EE A 2 put VAISS rrr EM A 2 Temperature Corrected Values eee A 4 Reference TRAINS C r A 5 Data Manage Mert cc tcc utes a i a ane en a cele onkar A 6 RS2320 Ii COMM UPON M A 6 Mains Supply for External Power Supply 0 eceeeeceeceeeeceeeeeeeeaeeeaeeaaeeaaeeaeeeaeeeaeeeaeeeaeeeaeees A 6 CDOT VOI TS CONG EUER A 6 Dimensions and WSN TEE A 7 Classificat OTS are a aaa araen aaa Ea aaa a aeaa Ea an Aaaa e aaa EE iaaea iea aa E Sa Aaea anA A 7 Calculated PDarameiers ANNE A 7 GND e UI A 7 Units Used in Measured and Input Parameters for Calculations ccccccccsesssecececeeseeeeseeeees A 8 Conversion Table for Units eccceecceec cece cece eee eeee eee cece cece cee e eee eaee cae seeeeeeeseeeseeeeeeeseeeeeeeeeeeeeees A 8 APPENDIX B MENU STRUCTURE eeeeeeeeeeeeeennnnn B 1 APPENDIX C MAINTENANCE LOG ccce C 1 APPENDIX D REPORT FORMATS aea rr uro rore nuno rante a xu n oRu Enna uanr D 1 Basic Patient Report ee M D 1 ORG Measurement Report eie A e erba uua d edu ead a uda ENEE D 2 ORG Statistics Report irme rcnt rr na onde ki e DN Ne T T EA EI Rn I Dn cd D 3 Controls Measurement Report sssssssssssssssssssssssseeeeeene nennen nennen nen n nennen nnne nennen D 4 Controls Statistics Report ENNEN EN
3. Material mean Lot 1 Lot 2 Lot 3 OPTI CHECK Swr ST Swr ST Swr ST aqueous control solution Level 1 72 1 25 1 38 1 07 1 10 0 69 0 75 Level 2 109 1 73 1 97 1 77 2 04 1 36 1 63 Level 3 155 1 48 1 89 1 76 2 19 1 31 1 69 Whole Blood Within Run precision in whole blood samples was evaluated at three different PO concentrations using multiple instruments and multiple cassette lots PO in Whole Blood Level 1 Level 2 Level 3 Average 48 4 83 3 398 8 St Dev 1 5 2 7 13 6 CV 3 1 6 0 3 4 n 18 18 18 Linearity The linearity of the dry PO sensor was established using whole blood samples tonometered with different gas mixtures of known gravimetric compositon The reference PO values of the tonometered blood samples were calculated from the gas composition using the following equation PO Barometric Pressure 47 0 Linearity of Whole Blood Samples Correlation Slope Intercept Coefficient Sy x Range n 0 98 4 00 0 998 8 05 7 701 191 Operator s Manual OPTI CCA TS PO2 B 3 PO Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS vs other PO Instruments on whole blood in a typical setting PO analysis of heparinized whole blood samples was performed at multiple clinical sites Samples were analyzed on the OPTI CCA TS in parallel with laboratory instrumentation operated by hospital personnel and controlled following the hospital s established procedures
4. Patient Entry parameters Parameters Fig 3 28 Normal 3 Inthe lt Units gt screen select the units for the Neg esee displayed parameters Fig 3 29 Q Up Home Fig 3 28 Select Units 4 The selection for Resolution on this menu determines the number of digits displayed and printed past the decimal point for all measured parameters NOTE The selection applies to sample results only Resolution is always High for Control and SRC results Resolution examples are shown in the following table ISystem Setup Units Not Ready 10 40 12 Nov System Parameters 3 mmHg mbarikPa Barometer Partial e e Pressures Law High i ci oun e pH 7 34 pH 7341 ot m e PCO 43 mmHg PCO 43 2 mmHg e PO 87 mmHg PO 86 8 mmHg e Na 143 mmol L Na 143 3 mmol L e K 4 6 mmol L K 4 57 mmol L Qoo Defauks H za e Cl 103 mmol L Cl 103 1 mmol L Ga p e Ca 1 21 mmol L Ca 1 21 mmol L e Glu 5 71 mmol L Glu 5 71 mmol L Fig 3 29 Select Units e BUN 18 5 mg dL BUN 18 5 mg dL e Lac 14 5 mmol L Lac 14 5 mmol L e tHb 14 6 g dL tHb 14 6 g dL e SO 90 SO 89 8 NOTE PO and PCO values above 100 mmHg are always displayed to the nearest whole number Operator s Manual OPTI CCA TS Syste m gt Setup gt Units Not Ready System tHb Cat Glucose Urea BUN Lactate Qoa Qv 10 40 Parameters gldL si giL d mmol L A mmol L D mmol L D mmol L e Defaults Home
5. En 4 1 ME ciim sine cette eee ene 4 1 4 2 QC COV CIV deoataai 4 1 4 3 Proficiency Testing 4 2 44 we E WEN d eoru ih iaeiaiai nasaian asiain aaaeaii iae 4 2 45 QC Recommendations iisi EE Eeer 4 3 Z5 Running an SRC E D E 4 4 4 5 2 Printing SRC Results c 4 7 4 5 3 Running Te TT 4 8 4 5 3 1 Running Controls OPTI CHECK OPTI CHECK PLUS see 4 8 454 Printing Control Reports c epit pu uan tS deti n Een RR PauU ROC EE 4 14 45 5 Sending Data to a Ce 4 15 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 4 Specimen Collection and Handling eese 5 1 e Ve EE 5 1 5 1 2 Sample Requirements EEN 5 1 5 1 3 Anticoagulants and Sample Collection Devices eese 5 1 RE ME d NUT ad mee 5 2 GRECE I IC REST EE 5 2 5 1 6 OPTI Medical ComfortSamplers nennen 5 2 D Handling and Storage of Samples EE 5 3 5 158 Test ene ue EE 5 4 52 Sample Preparation ene pn ara rushnaErueEcEEEiuSECE Eh nFRUKEESI TE UE EEUEMREEE RACE KR nnana 5 4 52 1 Whole Blood Samples entes dent tea eas d ig lenin ionamin 5 4 5 3 Running A Patient Sample eeescseseseeeseeseeeen nete nennen nennen 5 5 5 4 Printing Patient E eterne aont tainen Ip En satin a nS EE EEEEFEREPE EDU 5 14 II Operator s Manual OPTI CCA TS TABLE OF CONTENTS 6 MAI
6. En 4 1 41 C oc eee 4 1 AZ ee citi evinced een 4 2 4 3 Proficiency Testing 4 2 44 Calibration Verification eoe ttti c orit etate a a peu SE Rusa EES as Euer Ere EU 4 3 4 5 QC Becommiendalilolis unisce tate tnu Lco ca ER RR eR o ee eect need 4 3 4 5 1 Running an SRC E ET EN 4 4 4 5 2 Printing SRG TE 4 7 4 5 3 E Sp CER rot c 4 8 4 5 3 1 Running Controls OPTI CHECK OPTI CHECK PLUS eee 4 8 4 5 4 Printing Control Reports ac ccaniectanvsnonnnntetedecsanndansavardandenes avaa iekaisis 4 14 455 Sending Data Een E 4 15 Operator s Manual OPTI CCA TS 4 i 4 1 4 2 4 CALIBRATION AND QUALITY CONTROL CALIBRATION AND QUALITY CONTROL Calibration Each lot of OPTI cassettes is calibrated during the manufacturing process The calibration is performed using high precision standard solutions and gravimetrically prepared gas mixtures to determine the cassette s measurement characteristics at multiple points within the analyte s measurable range Every cassette package is then labeled with a bar code containing this calibration information as well as its lot number and expiration date Prior to running a sample the cassette s bar code is scanned into the analyzer by holding the cassette package in front of a conveniently located bar code scanner The cassette is then installed and a calibration verification is performed using a precision gas mixtu
7. d Manual Entry Last Entry Data QC System Manager Manager Manager AH Fig 6 28 Ready screen 6 10 7 Inthe lt New Gas Bottle gt screen Fig 6 25 press Yes to confirm the installation of a new gas bottle The analyzer will initiate a purge of the system which will be indicated on the status bar on the bottom of the screen Fig 6 26 NOTE If you need to remove the gas bottle and reinstall it respond No at the prompt lt New Gas Bottle gt You will then be prompted to enter the number of weeks in service using the numeric keypad Fig 6 27 Here you may refer back to the installation date which was recorded on the gas bottle 8 The unit will then return to the lt Ready gt screen Fig 6 28 Operator s Manual OPTI CCA TS 6 5 2 Changing the Printer Paper Fig 6 29 Paper Advance Button n Fig 6 30 Insert New Roll Fig 6 31 Tear Off Excess Paper Operator s Manual OPTI CCA TS 6 MAINTENANCE The thermal printer paper supplied by OPTI Medical contains an indicator strip to alert you when the paper roll should be changed To change the roll Open the cover on the top of the analyzer Press the paper advance button to eject any remaining paper Fig 6 29 Remove the old roll With the OPTI CCA TS powered on place a new roll of paper in the chamber and thread it into the feeder Use the diagram in the paper well to make sure the paper is inserted correctly
8. Calibration Reports Patient SRC d Errors Miscellaneous Reports Configuration Maintenance Q Up Home Fig 7 49 Select Control Data gt Control Diagnostics Ready 10 40 12 Nov Level Date pe View a E Ga Print g Mark a All ue 2 Down Q Up fone Fig 7 50 Select Measurement Data Control Diagnostics gt View Ready 10 40 12 Nov 2230 2 4 33 102 301 3 0 4 33 103 625 9 2 8 33 112 180 1 0 0 33 105 452 4 7 2 33 93 491 3 0 9 9 108 as em Fig 7 51 Control Diagnostics The lt Control Calibration Report gt shows details of measured signals in millivolts as well as drifts observed during measurement To print a controls report select lt Calibration Reports gt Controls gt in the lt Data gt screen Fig 7 49 In the lt Data Control Diagnostics gt screen Fig 7 50 select the desired measurement and press the View button to display the control results Fig 7 51 Use the Us and Dow buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 50 To print groups of results highlight the first measurement to be printed press Qj vex then select the last measurement to be printed All the measurements in between will be selected Press Q to select all results Press CaP to print your selection
9. Correlation Comparative Method Slope Intercept Coefficient Sy x Range n OPTIR 1 04 2 76 0 968 8 72 27 288 148 Analyzer A 0 97 3 73 0 992 5 24 27 0 423 8 110 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other PO Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different O gas mixtures to generate a wide range of PO values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Correlation Comparative Method Slope Intercept Coefficient Sy x Range n OPTI CCA Std PO sensor 0 94 4 84 0 998 9 77 19 9 642 8 161 Analyzer B 0 95 6 32 0 992 18 25 17 0 635 7 161 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Kautsky H Quenching of Luminescence by Oxygen Transactions Faraday Society 35 p 216 1939 3 CDI 3M Healthcare System 200 Extracorporeal Blood Gas Monitor See for example Lubbers DW Gehrich J Opitz N Fiber Optics Coupled Flourescence Sensors for Continuous Monitoring of Blood Gases in the Extracorporeal Circuit Life Supports Systems 4 p 94 1986 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer
10. Reference Normal Physiologic Alarm Critical 4 Press Limits 2 to advance to the next screen Fig 3 23 5 Select the parameter you want to change and press Edit to enter the new limit value 6 Press WS to accept the new limit value 3 11 3 CUSTOMIZATION Syste m gt Setup gt Normal Ranges Limits Not Ready 10 49 e Limits 1 Limits 2 uem 7 Press Limits 3 to advance to the next screen Fig 3 24 with the remaining parameters Low ij The instrument is preset to the following ranges of Cae Geall Gest limit values EM nt es pH 7 2 7 6 BUN gea Zei PCO 30 50 mmHg Lac 4 t Gei PO 70 700 mmHg b Zex 4 t amp Na 135 145 mmol L Co aa GEE SE ES E mmm CT 5 115 mmol L ge GERS Ca 1 12 1 32 mmol L Gm Dies Glu 60 0 120 0 mg dL Glu 3 3 6 6 mmol L Fig 3 24 Enter Limits 3 BUN 5 9 19 9 mg dL Urea 2 1 7 1 mmol L Lac 0 90 1 70 mmol L tHb 12 17 g dL SO 90 100 ER e Units may be changed See section 3 3 2 6 e Inall data input screens if unreasonable numbers are entered the system automatically flags the error and displays the valid range e f you wish to turn off limits flagging enter the system ranges for each parameter For instance for pH the low is 6 600 and the high is 7 800 See Analytes Section for specifications of the reportable ranges for each parameter measured e The limits en
11. Blood may be collected for analysis on the OPTI CCA TS with the OPTI Medical ComfortSampler to provide a filled shielded capillary tube After collection the ComfortSampler should be capped and transported in a horizontal position to the instrument for analysis within 30 minutes as with all specimens collected in capillary tubes Cooled samples provide relevant glucose values for up to 30 minutes uncooled samples for up to 10 minutes Serum must be separated within these time limits 8 4 7 Handling and Storage of Samples Please refer to CLSI Document H18 A3 Procedures for the Handling and Processing of Blood Specimens Approved Guideline Third Edition November 2004 for a detailed discussion of guidelines for the collection of acceptable specimens instrument calibration and quality control in pH and blood gas analysis including details of many potential sources of error which may cause inaccurate results Whole blood samples should be collected in a heparinized syringe ComfortSampler or capillary and analyzed as soon as possible after collection Immediately after collection check the syringe or other device for air bubbles and carefully expel any trapped bubbles following the manufacturer s recommended procedure Extreme caution should be used to avoid needle stick injury If collected in a syringe or vacuum tube mix the specimen thoroughly with anticoagulant by gentle inversion or by rolling the syringe between both hands Pr
12. Fig 2 2 Insert Battery Pack The status LED on the rear of the instrument is always on while the battery is being charged The LED blinks rapidly four times per second when the battery is fully charged It blinks slowly once every 1 5 seconds when charging a depleted battery 8 3 Turn on the Power Fig 2 3 Power Switch m e Locate the power switch on the left side of F the unit and switch to ON Fig 2 3 Operator s Manual OPTI CCA TS OPTI Medical OPTI CCA TS Version 3 00 ares STOP Memory Error Database Deleted S Be OPTIMedical 18 Fig 2 4 Startup screen Please Enter the Time Cancel OK Hour Minute 7 8 9 aj s e EA 0 Fig 2 5 Enter Time Cancel i Please Enter the Date Month Day X Year fun Jan Feb Mar d Apr May Jun Jul Aug Sep Oct Nov Dec OK Fig 2 6 Select Month Operator s Manual OPTI CCA TS 2 SETUP e This is the first screen that will appear after the power is turned on Fig 2 4 e Press X Setting the Time and Date e The system will now prompt you to enter the current time using the numeric keypad Fig 2 5 Enter hour and minutes and press OK e You will then be asked to enter the month Fig 2 6 e Select the month from the keypad and press OK 2 3 2 SETUP Please Enter the Date Month Day Year Jun 30 2010 Elea a aj 5 6
13. Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the pH sensor The following exogenous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount pH change Sodium fluorescein 26 mg dL unstable Cardio indocyanine green 0 5 mg dL 0 04 Methylene blue 25 mg dL 0 16 Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials may interfere with the pH measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments pH is expressed in pH units Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 7 166 0 003 0 003 0 003 Level 2 7 414 0 0003 0 002 0 002 Level 3 7 620 0 0005 0 003 0 006 Serum 7 524 0 001 0 003 0 003 Reduced Bovine Hemoglobin 7 44 0 0005 0 002 0 003 Solution All specific performance characteristics tests were run with defaul
14. T FN WARNING Low Gas 1 Test Remaining S WARNING Check Pump OK EN WARNING Check Pump Please Remove Cassette S 7 2 The battery voltage is low e Complete the current test by pressing Ur e Replace the battery or recharge it by plugging the unit into the main power supply as soon as possible The gas bottle will expire in two weeks e Press OK lis continue Make sure you have another gas bottle on hand or ordered If the percentage in the gas bottle reaches 4 96 this message will be displayed e Complete the current test by pressing OK e Replace the gas bottle at the completion of the test See Section 6 5 1 NOTE Replace the gas bottle at the next warning and the OPTI CCA TS will automatically perform the necessary 1 minute gas purge Otherwise use the diagnostic routine to perform the purge See Section 6 5 1 NOTE The gas bottle expires 9 months after installation or after exceeding the labeled expiration date whichever comes first The peristaltic pump is getting worn to continue measurement Perform pump diagnostic see Section 7 2 16 if this warning persists e Press OK e Ifthe pump diagnostic fails replace the pump cartridge see section 6 4 The peristaltic pump is getting worn e Remove the cassette e Retry with a new cassette e Change the peristaltic pump cartridge Operator s Manual OPTI CCA TS WARNING Bubble D
15. Cancel OK Fig 4 17 Scan Bar Code 83 Open Cover mi ore Cancel Fig 4 18 Open Cover Measuring 10 40 12 Nov Gas 83 Insert Cassette Baro 732 4 Cancel Fig 4 19 Insert Cassette 4 10 Scan the bar coded strip on the OPTI Cassette package by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer to automatically record the lot and calibration information for the specific cassette Fig 4 17 e The red line from the barcode scanner should cover the entire bar code e The unit will beep and the status light will turn green to confirm a valid bar code e Incase of an expired cassette the light will turn red NOTE Refer to special handling instructions inside the cassette box for refrigerated cassettes NOTE If the bar code is damaged or unreadable press lt Manual Entry gt and enter the bar code digits printed on the bar code label using the numeric keypad NOTE A control measurement may be made using any cassette lot or cassette type Open the sample chamber cover by pressing the release button Fig 4 18 Tear open the cassette pouch being careful not to tear the bar code Remove the cassette and wipe any excess moisture from the cassette with a clean dry cloth NOTE If the QC sample is to be introduced with a capillary tube remove the syringe adapter before placing the cassette into the chamber In
16. Date Initial Date Initial Date Initial Date Initial Replace peristaltic pump cartridge AS NEEDED Date Initial Date Initial Date Initial Date Initial Clean analyzer surfaces Change gas bottle Change printer paper Operator s Manual OPTI CCA TS C 1 APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Basic Patient Report E Glu example OPTI Medical OPTI CCA TS P50 26 7 mmHg Patient Report VntMode N A DD MMM YY HH MM TVol 0 mL MVol 0 L Pat ID 123456789012345 PIP 0 Access No 123456789012 Pplat 0 0 Sample No 2345 PS 68 PEEP 0 ACID BASE 37 0 C 38 5 C CPAP 0 pH 7 343 7 322 Rate f 0 bpm PCO2 41 0 43 8mmHg L Flow 0 Lpm PO2 84 9 93 5mmHg I E 1 1 0 BE icm mmol L BiLevel 0 0 0 0 tCO2 23 0 mmol L PuncSite LR HCO3 21 0 mmol L Bypass On Pump LECTROLYTES Na 140 2 mmol L Barometer 739 6 mmHg K 3 67 mmol L Operator ID 123456789012 S N 123456 LOT 123456 HEMOGLOBIN OXYGEN STATUS tHb 14 4 g dL Ref Lim S02 95 7 pH 7 20 7 60 Hct c 43 2 PCO2 30 50 mmHg PO2 70 700 mmHg METABOLITES Nat 35 145 mmol L Glu 62 1 mg dL K 3 5 5 1 mmol L Cl 95 115 mmol L ENTERED PARAMETERS Ca 1 12 1 32 mmol L Temp 38 5 xe Glu 60 0 120 0 mg dL Sex Male tHb 12 0 17 0 g
17. Fig 7 7 Battery Voltage 7 2 7 Checking the Cooling Fan Syste m gt Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Gas Valve Closed Cassette Valve Drive Position o0 Edit FSet Up Home Fig 7 8 Cooling Fan Operator s Manual OPTI CCA TS This selection lets you check the battery voltage From the lt Ready gt display press lt System Manager gt and lt Diagnostics gt e The second display in the lt Miscellaneous gt section shows the battery voltage Fig 7 7 e If the voltage is below 11 8V the battery needs to be recharged or may need replacement The purpose of this test is to check for proper functioning of the cooling fan From the Ready display press System Manager and Diagnostics e Select the Control tab e Press the lt On Off gt button under Fan to start the test Fig 7 8 e When lt On gt is selected you should feel the draft of the fan by placing your hand over the fan at the back side of the analyzer e Press Q SE lio return to the lt System gt screen 7 15 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 8 Checking the Gas Valve Syste m gt Diagnostics Not Ready 10 40 12 Nov Sensors Contro Tests Fan Gas Valve Off Closed Cassette Valve Drive Position 00 Edit FSet Q Up Home Fig 7 9 Gas Valve 7 2 9 Checking the Valve Drive ISystem Diagnostics Not Rea
18. Home Fig 4 10 Select SRC Data gt SRC Measurement Ready 10 40 12 Nov jJ View XK delete e Export All aa Statistics a Down Q oj Fig 4 11 SRC Measurements Data gt SRC Measurement View Ready 10 40 12 Nov Limits 7 417 7431 Q Up f rene Fig 4 12 View SRC Results Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL This menu allows you to print out SRC reports or SRC statistical information 1 From the Ready display select Data Manager gt Select lt SRC gt Fig 4 10 In the Data SRC Measurement screen Fig 4 11 press the 4 button to display the SRC results Fig 4 12 Use the Sj and 100 buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 4 11 To print groups of results highlight the first measurement to be printed press Q or L then select the last measurement to be printed All the measurements in between will be selected Press Q to select all results Press GP to print your selection Press the Statistics button to print out the statistics from the most recent 30 days of SRC measurements for all levels After printout the database can be deleted by pressing gt lt Delete If a password has been activated under Setup you must enter it at this time before the data 1s deleted T
19. P50 8 9 calculation A 11 reference ranges A 5 Parameters blanking 3 9 measurement ranges 1 1 A 1 reporting units 1 1 Password setting up 3 16 Operator s Manual OPTI CCA TS Patient data enter 5 8 information customizing 3 7 report printing 5 14 testing 5 1 Patient ID 3 7 5 9 PCO2 Dry Sensor B Lac Cassette PCO2 B 1 Clinical significance PCO2 B 1 Correlation to Other Methods PCO2 B 4 Interferences PCO2 B 2 Linearity PCO2 B 3 Measurement principle PCO2 B 1 Measurement range PCO2 B 1 Reference intervals PCO2 B 1 References PCO2 B 4 Reproducibility PCO2 B 3 SRC limit values PCO2 B 1 Peristaltic pump cartridge description 1 5 replacing 6 7 pH pH 1 clinical significance pH 1 measurement principle pH 1 measurement range pH 1 SRC limit values pH 1 temperature corrected A 12 pH Dry Sensor B Lac Cassette pH B 1 Clinical significance pH B 1 Correlation to Other Methods pH B 4 Interferences pH B 2 Linearity pH B 3 measurement principle pH B 1 measurement range pH B 1 Reference intervals pH B 2 References pH B 4 Reproducibility pH B 3 SRC Limit Values pH B 2 PO2 Dry Sensor B Lac Cassette PO2 B 1 Clinical significance PO2 B 1 Correlation to Other Methods PO2 B 4 Interferences PO2 B 2 Measurement principle PO2 B 1 Measurement range PO2 B 1 Reference intervals PO2 B 1 References PO2 B 4 Reproducibility PO2 B 3 SRC Limit Values PO2 B 1 Pollution degree A 1 Potassium K K 1 clinical significance K
20. Reports Statistics Ca bration Reports Patient SRC Controls Errors Miscellaneous Reports Configuration Maintenance Qu Fy Home Fig 5 24 Select Patient Report Data gt Patient Measurement Ready 10 40 12 Nov Patient ID P 763824543 Tee e x 787356987 ee 6 Up Za Home Fig 5 25 Measurement Results 5 14 This menu lets you print out patient reports You can print out individual patient results groups of patient results or all the results in memory 1 From the lt Ready gt display select lt Data Manager gt 2 Press lt Patient gt Fig 5 24 3 Inthe lt Patient Measurement gt screen Fig 5 25 press the V button to display the measurement results The sorting order within the individual columns may be changed from ascending to descending by pressing the column header 4 To print individual results highlight the desired measurement To print groups of results highlight the first measurement to be printed press Qe then select the last measurement to be printed All the measurements in between will be selected Press Q to select all results 5 Press GaPrint to print your selection 6 After printing patient data may be deleted by pressing gt lt Delete e After data has been deleted the system will return to the Data Manager gt 7 Press f Pene to return to the Ready screen e Ifa password has been selected unde
21. slope m comparative method results intercept b PO2 B 4 Operator s Manual OPTI CCA TS ANALYTES SODIUM Sodium Na Clinical Significance Sodium is the major cation of extracellular fluid Its primary functions in the body are to chemically maintain osmotic pressure and acid base balance and to transmit nerve impulses Sodium functions at the cell membrane level by creating an electrical potential between different cell membranes causing the transmission of nerve impulses and neuromuscular excitability to be maintained Sodium is involved in some enzyme catalyzed reactions as a cofactor The body has a strong tendency to maintain a total base content and only slight changes are found even under pathologic conditions Low sodium values hyponatremia usually reflect a relative excess of body water rather than a low total body sodium Reduced sodium levels may be associated with low sodium intake sodium losses due to vomiting or diarrhea with adequate water and inadequate salt replacement diuretics abuse or salt losing nephropathy osmotic diuresis metabolic acidosis adrenocortical insufficiency congenital adrenal hyperplasia dilution type due to edema cardiac failure hepatic failure and hypothyroidism Elevated sodium values hypernatremia are associated with conditions with water loss in excess of salt loss through profuse sweating prolonged hyperpnea severe vomiting or diarrhea diabetes insipidus or diabetic a
22. 15 Fig 5 14 Edit patient data 1 iMeasurement gt Patient Data Measuring 10 40 12 Nov tHb es FIO2 n Heat MCHC Ir ea P50 Hest Back Page 2 of 7 Next ren Zonen NES Fig 5 15 Edit patient data 2 Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING Press the lt Last Patient Info gt button Fig 5 13 to use the last patient info as the default for the current patient info This option will populate all patient info fields with the last patient data including patient ID and operator ID numbers If operator ID security is enabled the operator ID field will display the operator ID of the last patient sample All patient information used as the default can be edited Verify that patient ID operator ID and all other input parameters are correct for every patient sample measurement Press the lt Patient Info gt button to enter new patient info or to not use the last patient info as the default The first patient data entry screen contains the following information Fig 5 14 Operator ID 11 alphanumeric characters Patient ID 15 alphanumeric characters Accession No 12 alphanumeric characters Date of Birth DOB Temperature default value 37 0 C Sex unknown male or female NOTE Patient and Operator IDs and Accession Nos may be entered using the bar code scanner 10 To enter patient data press Edt Use the alphanumeric
23. Fig 3 30 Select Units 12 Nov mmol L D mg dL c mg dL e mg dL b maldL Cc H Save Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 5 Press the lt Parameters gt tab to go to the next screen Fig 3 30 and select the units for the remaining parameters Your OPTI CCA TS has been factory preset to the following units e Baro Partial Pressure mmHg e Temperature C e Resolution Low e tHb g dL e Electrolytes mmol L e Glucose mmol L e BUN mg dL e Lac mmol L NOTE The OPTI CCA TS automatically recalculates the units stored in the database to the changed unit value 6 Press Se to accept the changes 7 Press Q UP to return to the Setup screen or Home to return to Ready 3 15 3 CUSTOMIZATION 3 3 3 Miscellaneous 3 3 3 1 Setting up Security Not Ready 10 40 12 Nov Patient QC Miscellaneous Hardware Printer Maintenance Language Q Up Home Fig 3 31 Select Security 3 3 3 1 1 Setting Up a Password System Setup Security Not Ready 10 40 12 Nov Password QCLockout OPIDs Password Enable SetupPW gea Qoi H Save Q Up Home Fig 3 32 Enter Password 3 16 The OPTI CCA TS has three types of security 1 A Password Function to limit access to various system functions See section 3 3 3 1 1 2 QC Lockouts to help hospitals meet their QC policies See section 3 3 3 1 2 3 ASecure Operat
24. Fig 4 13 Operator s Manual OPTI CCA TS Enter Operator ID E I MS Er Ee sad ran re ue ats ET S ep Ua EN a a a Aa ral ea M rela Ee cur nem ax v al Fig 4 14 Enter Operator ID Ready 10 40 12 Nov Gas 83 Baro 7324 Select Level Cancel OK Fig 4 15 Select QC Level Control Information Correct Lot XXXXXX Level X Fig 4 16 Confirm Lot Number Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL 3 Enter your Operator ID or 4 digit PIN using the alphanumeric keypad Fig 4 14 To bypass this function press 0K NOTE If Operator ID is configured as required in Setup you cannot go to the next step until a number is entered NOTE If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner 4 Select the desired level Fig 4 15 and press OK 5 Press Yes if the lot number is correct Fig 4 16 NOTE If a new lot number of QC material is entered make sure the ranges have been entered into the system prior to running a sample See Chapter 3 Customization If the password function is enabled you will be asked for it before deleting the database for the old lot number 4 9 4 CALIBRATION AND QUALITY CONTROL Ready 10 40 12 Nov f Gas Scan Cassette Barcode 83 l Baro 732 4
25. Fig 6 30 As soon as the printer detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if the paper is present To advance paper after the initial installation press the red paper advance button located on the left side of the printer See Fig 6 29 Close the top cover of the analyzer and tear off any excess paper Fig 6 31 6 11 6 MAINTENANCE 6 5 3 Performing Routine Cleaning 6 12 The OPTI CCA TS Analyzer is designed to require very little maintenance Routine cleaning consists of wiping the exterior analyzer surfaces with a soft damp cloth NOTE Never use strong or abrasive cleaners on the OPTI CCA TS Analyzer Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 DIAGNOSTICS AND TROUBLESHOOTING 7 1 n WR eg Displays P ia 7 1 TAr WN dc tct 7 12 7 2 1 CHECKING VETSIONS m 7 12 7 2 2 Checking System Temiperetules sn quis seis oberste ordres petites etre e tape PUE IUE 7 13 T 2 9 Checking Gas PISS SUNG RTT 7 13 1 24 Checking WE a hae elle nep 7 14 7 2 5 Verifying Barometric Pressure seesgeustebseger tege degREEeEdeRA dE eESteeE eeh ESAERENeeeue eege 7 14 Lab Checking te Battery e 7 15 ro Checking the Cooling FaN eee cR 7 15 7 2 8 Checking the Gas Valve T E 7 16 G29 Checking the Valve Driv Gisiisccivrctsascscavtv
26. Fig 7 47 Select Measurement Data gt SRC Diagnostic gt View Ready 10 40 12 Nov Senso mV Drft SEE 1 31 1 0 09 0 03 2 494 0 08 0 01 3 357 0 09 0 02 4 35 0 0 03 0 00 5 92 8 0 04 0 00 6 949 0 02 0 00 Q Up Za Home Fig 7 48 SRC Diagnostics Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The lt SRC Calibration Report gt shows details of measured signals in millivolts as well as drifts observed during the measurement e To print an SRC report select Calibration Reports gt SRC gt in the lt Data gt screen Fig 7 46 e Inthe lt Data SRC Diagnostics gt screen Fig 7 47 select the desired measurement and press the View button to display the SRC results Fig 7 48 Use the lue and Dow buttons to display the previous or next page of results e To print individual results highlight the desired measurement Fig 7 47 To print groups of results highlight the first measurement to be printed press ak then select the last measurement to be printed All the measurements in between will be selected Press Q to select all results e Press GaPrint to print your selection e Press Ue to return to the lt Data gt screen 7 29 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 22 3 Control Calibration Report 7 30 Ready 10 40 12 Nov Measurement Reports Statistics Patient SRC Controls
27. ISystem Setup Normal Ranges Limits Select Range Name Reference c Normal gt Physiologic c Alarm c Critical c Q Up Fy Home Fig 3 22 Select Limits System gt Setup gt Normal Ranges Name Limits pH Edi 4 Edit PCO2 Edt 4 Edit PO2 Z Edit ZEdit Na Edi Edit K Edit Z Edit CI Edit Edit Qon Defaults H Save Q Up Home Fig 3 23 Enter Limits 2 Operator s Manual OPTI CCA TS This menu enables you to change both the limits name as it appears on the printout and the limit values themselves for pH PCO and all other measured parameters These limit names can be based on your hospital policy and may be selected from the following Reference Normal Physiologic Alarm or Critical A result that is outside the limits you define here will be flagged with an up arrow if high or down arrow if low A message is included on the printout explaining each arrow using the name selected here NOTE When the patient temperature has been changed both the uncorrected and corrected parameters will be checked against the limit values programmed here and flagged accordingly 1 From the Ready display select System Manager and Setup 2 Inthe System Setup menu press Normal Ranges Alarm Limits Fig 3 21 3 Onthe Limits 1 gt tab select the limits range name you wish to use Fig 3 22
28. LOW NORMAL HIGH Units 60 0 3 100 0 3 170 0 3 mmHg Operator s Manual OPTI CCA TS PO2 1 PO ANALYTES 2 Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments PO is expressed in mmHg Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 68 9 0 13 0 2 0 59 0 9 0 61 0 9 Level 2 100 6 0 09 0 1 0 87 0 9 0 87 0 9 Level 3 142 7 0 13 0 1 1 37 1 0 1 38 1 0 Serum 92 2 0 08 0 1 0 72 0 8 0 73 0 8 Reduced Bovine Hemoglobin 83 1 0 15 0 2 0 61 0 7 0 63 0 8 Solution All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Precision and Recovery on Whole Blood Whole blood was tonometered at 37 C to various levels of gravimetrically prepared gases with O concentrations certified to 0 03 absolute by the manufacturer For each tonometered level 3 replicates were run on each of three OPTI CCA TS systems All values are in mmHg Expected n Observed Swr bias Recovery 20 8 7 21 2 0 97 0 4 102 96 41 5 7 39
29. OPTI Sensor Cassettes Type B BP7562 pH PCO PO tHb SO Type E BP7587 pH PCO PO Na E tHb SO Type E Ca BP7560 pH PCO PO Na K Ca tHb SO Type E Cl BP7559 pH PCO PO Na K Cl tHb SO Type E Glu BP7564 pH PCO PO Na E Glu tHb SO Type E BUN urea BP7588 pH PCO PO Na K BUN urea tHb SO Type B Lac BP7561 pH PCO PO Lac tHb SO Type B60 BP7586 pH PCO PO Use For measurement of various analytes with the OPTI CCA TS Analyzer Contents Box contains 25 individually packaged cassettes Each disposable plastic cassette contains buffer and optical sensors Composition Aqueous HEPES bicarbonate buffer solution 0 2 mL with biocides Storage Refer to package labeling Stability Expiration date and lot number are printed on each cassette container label Standard Reference Cassettes SRCs Use For diagnostic and daily QC check of the OPTI CCA TS Contents Each package contains one reusable SRC Cassette Composition Stabilized optode sensors with assay values Level Level 2 Optional Level 3 BP7536 BP7554 BP7543 pH 7 080 7 120 7 380 7 420 7 580 7 620 pH units PCO 68 0 72 0 38 0 42 0 18 0 22 0 mmHg PO 57 0 63 0 97 0 103 0 167 0 173 0 mmHg Na 123 0 127 0 143 0 147 0 163 0 167 0 mmol L K 2 2 2 8 4 2 4 8 6 7 7 3 mmol L Ca 1 7 1 9 1 0 1 2 0 6 0 8 mmol L Cl 78 0 82 0 103 0 107 0 128 0 132 0 mmol L Glu 36
30. Performing tHb Calibration 6 3 1 Performing HbCal tHb Calibrator Not Ready 10 40 12 Nov mm 1 In the Ready display select QC See Manager gt 2 Inthe QC Manager menu select SRC lt tHb Calibrator gt Fig 6 1 Q Up Fy Home Fig 6 1 Select tHb Calibrator Operator s Manual OPTI CCA TS 6 1 6 MAINTENANCE Enter Password 3 Use the numeric keypad to enter the password 7 8 9 e factory default 404 Fig 6 2 4 5 6 1 2 3 0 Cancel OK Fig 6 2 Enter Password 4 Usethe alphanumeric keypad to enter the Operator ID or press ok _ to bypass this function Fig 6 3 Enter Operator ID NAS NOTE If Operator ID is configured as required iae ees ese CH de 1 in Setup you cannot go to the next step Lc TE E u al unless a valid Op ID is entered E MEC ca ra ea NOTE If Secure Op IDs is activated under Setup a o sj 5 5 you will be prompted for your 4 digit PIN Es ge er J instead of your Op ID z al Ie es Ice NOTE Bar coded Operator IDs may be entered x vin using the bar code scanner Cancel Ok Fig 6 3 Enter Operator ID Ready 10 40 12 Nov 5 Select lt tHb Calibrator gt Fig 6 4 Select tHb Calibration Method Last Blood tHb Calibrator Fig 6 4 Select tHb Calibrator 6 2 Operator s Manual OPTI CCA TS Enter Lot Number SC SEA EC EX ES S Cancel O
31. 148 102 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS Na 3 ANALYTES POTASSIUM Potassium K Clinical Significance Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the cell itself Ninety percent of potassium is concentrated within the cell and damaged cells release potassium into the blood Potassium plays an important role in nerve conduction muscle function and helps maintain acid base balance and osmotic pressure Elevated potassium levels hyperkalemia can be found in oligouria anemia urinary obstruction renal failure due to nephritis or shock metabolic or respiratory acidosis renal tubular acidosis with the K H exchange and hemolysis of the blood Low potassium levels Aypokalemia can be found in excessive loss of potassium through diarrhea or vomiting inadequate intake of potassium malabsorption severe burns and increased secretion of aldosterone High or low potassi
32. All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods BUN urea linearity is established with N I S T SRM 909b Human Serum Correlation Slope Intercept Coefficient Sy x Range n 1 0046 1 58 0 99919 1 75 16 86 6 BUN 2 Operator s Manual OPTI CCA TS ANALYTES Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting BUN UREA Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A serum 0 940 2 97 0 9975 1 05 8 89 68 Analyzer B serum 1 058 3 04 0 9988 1 12 4 106 102 Analyzer C plasma 0 993 0 44 0 9953 1 00 6 65 4
33. Analyzer B plasma mg dL 0 9986 2 34 0 9866 8 5 44 398 167 mmol L 0 9986 0 13 0 9866 0 47 2 4 22 1 167 OPTI CCA mg dL 1 058 2 36 0 97 21 6 37 395 103 whole blood vs plasma mmol L 1 058 0 13 0 97 1 20 2 1 21 9 103 Analyzer C serum 0 950 5 73 0 9784 10 51 78 294 68 Analyzer D serum 0 991 3 99 0 9772 10 74 36 344 102 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Glu 4 Operator s Manual OPTI CCA TS ANALYTES BUN UREA BUN Urea Clinical Significance Urea is produced in the liver as a by product from the breakdown of amino acids These are transaminated and deaminated to ammonia which is a toxin Detoxification of ammonia occurs in the urea cycle where two molecules of ammonia are joined to a molecule of carbon dioxide to form urea On an average protein diet urinary excretion expressed as urea nitrogen is 12 to 20 g day Abnormal Levels The blood urea reflects the balance between production and excretion Causes of high blood urea levels gt 7 1 mmol L urea 20 mg dl BUN These may result from increased production or decreased excretion Causes of increased
34. Fig 7 17 e The system will now check the optics Fig 7 18 e At the completion of the test a printout of the results will be printed and the lt Remove SRC gt message will be displayed Fig 7 19 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 14 Checking the RS232 Interface ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics Flow Pump Display Touch Gas Test Lactate Setup Ethernet Q Up Py Home Fig 7 20 RS232 Interface RS232 Test Jumper pins 2 to 3 E Fig 7 21 Jumper Pins 2 to 3 RS232 Test RS232 PASS S Fig 7 22 Interface Test Pass 7 20 The purpose of this test is to check for proper functioning of the serial interface From the lt Ready gt display press lt System Manager gt Diagnostics gt Select the lt Tests gt tab Press lt RS232 gt to start the test Fig 7 20 It is important to have pins 2 and 3 send and receive see Appendix A p A 6 shorted together Fig 7 21 Press OK and the system will send out a test string and check if it can be received The instrument will display a lt Pass gt or lt Fail gt message Fig 7 22 Press ok to return to the Tests screen Operator s Manual OPTI CCA TS 7 2 15 Checking the Pump Flow ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics Gas Test 1 Display Touch Lactate Se
35. Heparin salts are the only recommended anti coagulants acceptable for use on the B Lac cassette Reproducibility Controls LACTATE Within Run Swr and Total ST Precision were determined from 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for three different lots of B Lac cassettes are shown below Lactate values in mmol L Material mean Lot 1 Lot 2 Lot 3 OPTI CHECK Swr ST Swr ST Swr ST aqueous control solution Level 1 0 89 0 12 0 14 0 09 0 1 0 06 0 09 Level 2 2 39 0 17 0 19 0 16 0 18 0 09 0 13 Level 3 4 20 0 28 0 31 0 17 0 22 0 22 0 26 Whole Blood Within Run precision in whole blood samples was evaluated at three different lactate concentrations using multiple instruments and multiple cassette lots Lactate in Whole Blood Level 1 Level 2 Level 3 Average 2 81 4 03 5 44 St Dev 0 16 0 18 0 32 CV 5 6 46 5 9 n 12 12 12 Operator s Manual OPTI CCA TS Lac 3 LACTATE ANALYTES Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Linearity for the measurement of Lactate has been established versus the gravimetric concentration of lactate in a dilution sequence of aqueous buffers following CLSI guideline EP6 A Correlation Slope Intercept Coefficient R Sy x Range n 0 93 0 08 0
36. Press Q Up lto return to the lt Data gt screen Operator s Manual OPTI CCA TS 7 2 22 4 Error Log Ready 10 40 12 Nov Measurement Reports Statistics Patient SRC Controls Calibration Reports Patient SRC Controls EIC n Configuration Maintenance Q Up Fy Home Fig 7 52 Select Errors iData gt Errors Ready 10 40 12 Nov Error Log gt lt Delete E Print Ow gei Fig 7 53 Print or Delete Error Log Delete the Error Log Fig 7 54 Delete Error Log 7 DIAGNOSTICS AND TROUBLESHOOTING This menu gives you the option to print or delete the error log from the database e To print an error log select Calibration Reports gt Errors in the Data screen Fig 7 52 e Press Prnt to print the error log Fig 7 53 e Press 2 D ci to delete the error database e Confirm your choice by pressing Yes in the lt Delete the Error Log gt screen Fig 7 54 e Press Up to return to the Data screen Operator s Manual OPTI CCA TS 7 31 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 22 5 Configuration Report Ready 10 40 12 Nov Measurement Reports Statistics Patient SRC Controls Calibration Reports Patient SRC Controls Errors Configuration Maintenance Fy Home Fig 7 55 Configuration Report 7 2 22 6 Maintenance Log IData gt Maintenance Ready 10 40 12 Nov Maintenance Log QB Print yc De
37. Sensor Cassettes see Chapter 9 Supplies in various analyte configurations Standard Reference Cassette Level 1 BP7536 Standard Reference Cassette Level 3 BP7543 Calibration Gas Bottle BP7001 Printer Paper HP0070 The OPTI CCA TS automatically processes the sample through the necessary steps then displays and prints the results For details of this operation please refer to Chapter 5 of the Operator s Manual Operator s Manual OPTI CCA TS 8 5 8 OPERATING PRINCIPLES 8 5 2 Test Conditions Sample Size Sample Type Sample Application Ambient Temperature Relative Humidity Type of Measurement a minimum of 125 uL 60uL for B60 cassette heparinized whole blood serum and plasma syringe capillary or ComfortSampler 10 32 C 50 90 F 5 to 95 non condensing optical fluorescence pH PO PCO Na K Ca CT Glu BUN urea Lac and reflectance tHb SO 8 5 3 Input Values Parameter Range Default Display Units Resolution Patient ID 15 alphanumeric characters Blank Operator ID 11 alphanumeric characters Blank Accession Number 12 alphanumeric characters Blank Patient temperature T 14 to 44 37 0 0 1 C 58 to 111 0 1 F Patient Sex Male female or Hemoglobin type adult or fetal adult DOB MMM DD YYYY Puncture Site LR RR LB RB LF RF LR Cord Scalp where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right Femoral Cord
38. aspiration and was not able to aspirate enough sample e Press OK and discard the cassette The bar code was invalid The OPTI CCA TS either misread the bar code label or it is an invalid bar code for the OPTI CCA TS e Press OK to retry e If the error message appears again check the product package for intended use e Check the bar code scanner see Section 7 2 11 e Clean the bar code scanner Using a lint free cloth dampened with a dilute alcohol or ammonia based cleaner gently wipe the face of the scanner clean e Retry the bar code Operator s Manual OPTI CCA TS ERROR Invalid Barcode Check Time and Date A E ERROR Expired Barcode Check Time and Date O ERROR Invalid Barcode Different QC Lot OK RE ERROR Invalid tHb Calibrator OK re ERROR Invalid QC Lot OK Al ERROR Invalid SRC H Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The bar code was invalid The OPTI CCA TS either misread the bar code or the product 1 e gas bottle cassette or SRC has expired e Press OK to retry e Ifthe error message appears again check the date in System gt Time and Date e Verify the product expiration date The cassette expiration date has been reached e Press OK to retry e Ifthe error message appears again check the date in System gt Time and Date e Verify the product expiration date T
39. etc of the system Second when a sample cassette is inserted it performs an extensive quality check prior to patient sampling to ensure among other things that the reagent system contained within the cassette is within pre defined limits If it is not an error message occurs and the cassette is discarded In addition automatic checks are performed of packaging integrity temperature control proper fluidic control bubble detection etc This approach provides a quality control check of the system similar to traditional liquid QC without incurring additional costs to the laboratory Every hospital is required to develop its own policies and procedures for quality control checks Minimum guidelines are defined by a variety of regulatory agencies Many agencies have updated their regulations to incorporate equivalent QC methods such as the SRC Some however have not 8 10 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES For agencies requiring a liquid QC material and for institutions requiring additional QC checks OPTI CHECK and OPTI CHECK PLUS are available OPTI CHECK and OPTI CHECK PLUS are specially formulated aqueous liquid control materials that contain all analytes measurable by the OPTI CCA TS They contain a stable suspension of polystyrene micro beads which reflect and partially absorb red and infrared light similarly to erythrocytes allowing true measurement of tHb and SO The three control levels contain three differen
40. linearity for the OPTI CCA TS measurement has been established against reference materials or methods Sodium linearity is established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions Sodium and by measurement of N I S T Standard Reference Material 956a Electrolytes in Human Serum Sodium jsp Correlation Slope Intercept Coefficient Sy x Range n Sodium 0 9788 2 456 0 99911 1 32 104 188 30 Sodium 1 0172 3 244 0 99957 0 55 121 161 18 NIST Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 6500 50 15 0 5721 2 21 126 149 103 Analyzer B whole blood 0 9313 9 34 0 9180 1 95 129 156 173 Analyzer C whole blood 1 084 0 226 14 929 3 176 0 9784 1 826 128 174 105 Analyzer D whole blood 1 080 0 021 6 382 2 855 0 9678 2 007 117 163 174 Analyzer E serum 0 873 15 49 0 8911 1 77 128 149 68 Analyzer F serum 1 025 4 57 0 9376 1 57 127
41. may interfere with the ion measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments Potassium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 1 2 61 0 004 0 2 0 026 1 0 0 026 1 0 Level 2 4 50 0 005 0 1 0 030 0 7 0 030 0 7 Level 3 5 58 0 006 0 1 0 048 0 9 0 47 0 4 Serum 7 11 0 010 0 1 0 08 1 1 0 08 1 1 Reduced Bovine Hemoglobin 2 92 0 004 0 1 0 02 0 8 0 02 0 8 Solution K 2 Operator s Manual OPTI CCA TS ANALYTES POTASSIUM All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Potassium linearity 1s established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions Potassium and by measurement of N LS T Standard Reference Material 956a Electrolytes in Human Seru
42. of range values with reference to the end value of the measurement range for example the printed report will show a PCO value of 220 mmHg as PCO gt 200 mmHg Meas Lim For measurement ranges of the individual analytes see Analyte Section of this Operator s Manual 3 Mahoney JJ Wong RJ Van Kessel AL Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 79 1993 J B Henry Clinical Diagnosis and Management by Laboratory Methods 19th Ed 1996 p 590 777 8 12 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES 8 5 10 Interferences Selected substances endogenous and exogenous to human blood were tested for interference in accord with CLSI EP7 A2 These substances were selected on the basis of their optical absorbance or fluorescence properties likely to affect the optical signal measured by the OPTI CCA TS or the optical properties of the sensor measured by the analyzer To cause interference to the optical sensors the substances must be highly mobile low molecular weight and highly colored in order to penetrate the optode membrane barriers quickly within the 90 sec measurement interval and then strongly absorb light or emit light of the proper color To cause interference to the tHb and SO reflectance measurements the substances must strongly absorb or scatter red or infrared light relative to normal whole blood The following substances were teste
43. setting up 3 23 Configuration report 7 32 Consumable items 9 2 Control Reports printing 4 14 Conversion units A 8 Cooling fan checking 7 15 Correlation factors setting up 3 13 Customization 3 1 D Data export 4 15 management A 6 manager 3 1 patient enter 5 9 Daylight savings time setting 3 2 Diagnostic reports control 7 30 patient 7 28 SRC 7 29 Diagnostics 7 1 7 12 Dimensions and weight A 7 INDEX Display test 7 22 Hydrogen ion concentration 8 9 daily 6 1 calculation A 8 log C 1 E reference ranges A 5 quarterly 6 1 Error displays 7 1 temperature corrected A 12 weekly 6 1 Error report 7 31 I Maintenance report 7 32 Ethernet interface Manuals 9 2 test 7 27 Input values 8 6 A 2 Menu structure B 1 Installation See Setup Model and serial numbers 1 6 F Interface N Ethernet test 7 27 E RS232 test 7 20 Interferences 8 13 Factory settings checking 7 17 Normalized ionized calcium reference ranges A 5 G Ionized Calcium Ca Normal ranges clinical significance Ca 1 setting 3 11 Gas bottle correlation to other methods Ca 3 O Operating altitude A 1 Operating parameters A 2 Operating principles 8 1 Operation analyzer 8 2 Operator ID 3 7 5 9 secure setting up 3 19 changing 6 9 description 1 8 installing 2 5 Gas I O Ports replacing 6 8 Gas pressure checking 7 13 Gas test 7 24 interferences Ca 2 linearity Ca 3 measurement principle Ca 1 measurement range Ca 1 normalized A 13 reference
44. 0 44 0 106 0 114 0 296 0 304 0 mg dL Glu 2 00 2 44 5 88 6 33 16 43 16 87 mmol L BUN 4 2 7 0 26 6 29 4 68 6 71 4 mg dL Urea 1 5 2 5 9 5 10 5 24 5 25 5 mmol L Lac 0 70 1 30 2 00 3 00 4 50 5 50 mmol L Lac 6 3 11 7 18 0 27 0 36 0 54 0 mg dL tHb 18 5 21 5 12 5 15 5 6 5 9 5 g dL SO 68 0 72 0 88 0 92 0 96 0 100 0 96 Storage Refer to package labeling Stability Expiration date and lot number are printed on each package label and encoded on the attached bar code label 8 14 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES Calibration Gas BP7001 Use For calibration of pH PCO and PO in the OPTI CCA TS Analyzer Contents Each disposable low pressure cylinder contains approximately 2 liters of gas at less than 145 psi at 21 C Composition Oxygen 14 0 0 02 Carbon Dioxide 6 0 0 02 Nitrogen balance Storage Refer to package labeling Battery Charger Optional BP7036 Use For fast charging of extra battery pack for the OPTI CCA TS Contents Each charger contains a power supply with circuitry Input voltage 100 240 VAC 50 60 Hz Storage Refer to package labeling Precautions Use of calibration solutions calibration gas or optodes not manufactured by OPTI Medical Systems could void the warranty Once used the sample cassette holds human body fluids which may be potentially infectious handle with appropriate care to avoid skin contact or ingestion For in vitro diag
45. 1 correlation to other methods K 3 interferences K 2 linearity K 2 measurement principle K 1 measurement range K 1 reference intervals K 2 references K 3 reproducibility K 2 SRC limit values K 1 Principles of operation 1 1 Principles of procedure 8 1 Printer description 1 5 test 7 18 Printer paper changing 6 11 installing 2 4 Proficiency testing 4 2 Pump flow checking 7 21 Pump motor test 7 22 Q QC lockouts 3 16 3 17 overview 4 1 recommendations 4 3 results 4 13 setup 4 4 QC Sample running 4 8 Quality control 4 1 8 10 R Reference intervals 8 11 Report formats D 1 Reports Configuration D 6 Controls Measurement D 4 Controls Statistics D 5 diagnostic 7 28 Error D 8 D 9 Maintenance D 7 Patient D 1 SRC Measurement D 2 SRC Statistics D 3 Operator s Manual OPTI CCA TS INDEX Routine cleaning performing 6 12 RS232 interface pin configuration A 6 test 7 20 S Sample collection devices 5 1 8 3 handling 5 1 handling and storage 5 3 8 4 preparation 5 4 requirements 5 1 8 3 whole blood 5 4 Sample fillport description 1 7 Sample measurement chamber SMC description 1 4 Secure Operator ID 3 16 setting up 3 19 Sensor cassette description 1 7 Setup analyzer 2 1 Sodium Na Na 1 clinical significance Na 1 correlation to other methods Na 3 interferences Na 2 measurement principle Na 1 measurement range Na 1 reference intervals Na 2 references Na 3 SRC limit values
46. 4 2 3 Cancel OK Fig 2 7 Enter Date NotReady A 1040 12 Nov Battery 13 0 OK A so Not Ready Low Gas Bottle p Data Qc System Manager Manager Manager d 1013 Low Gas Fig 2 8 Select New Gas Bottle Scan Barcode for New Gas Bottle Manual Cancel Please Insert Gas Bottle OK Cancel e Jn the next screen you may enter the current day Fig 2 7 e Press ok and enter the 4 digit year e After entering the current time and date press OK to save your settings Installing a New Gas Bottle e This screen will appear after initial power up sequence when no gas bottle 1s present Fig 2 8 e Press New Gas Bottle e Open the gas bottle by unscrewing the cap Scan the new gas bottle bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer e The red line from the bar code scanner should cover the entire bar code e The analyzer will beep when the bar code is accepted e The bar code can be found on the gas bottle instructional insert e Record the date of installation on the gas bottle for later reference NOTE To enter the bar code manually press Manual and enter the bar code using the numeric keypad e Press OK when prompted to insert the gas bottle Operator s Manual OPTI CCA TS K E v Fig 2 9 Gas Bottle New Gas Bottl
47. 4 7 4 Evan s Blue 5 0 mg dL lt 1 17 Methylene Blue 25 mg dL 3 0 37 ENDOGENOUS Carboxyhemoglobin 10 2 0 lt 2 Carboxyhemoglobin 20 3 3 lt 2 Methemoglobin 13 1 9 7 THB SO2 2 Operator s Manual OPTI CCA TS ANALYTES tHb SO Rapidly sedimenting blood samples should be mixed thoroughly and immediately aspirated into the OPTI cassette as described above in Handling and Storage of Samples to ensure accurate tHb measurements If allowed to sediment the blood sample s reported tHb may be falsely high or low Fetal hemoglobin taken from cord blood extracts was tested and showed no interference to the tHb and SO measurement Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments ctHb is expressed in g dL and SO2 in 9o Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS Level 1 ctHb 19 7 0 009 0 1 0 049 0 3 0 05 0 3 aqueous control solution SO296 77 8 0 03 0 03 0 13 0 2 0 13 0 2 OPTI CHECK PLUS Level 2 ctHb 14 2 0 02 0 1 0 07 0 5 0 08 0 5 aqueous control solution SO2 86 8 0 03 0 1 0 11 0 1 0 11 0 1 OPTI CHECK PLUS Level3 ctHb 8 84 0 009 0 1 0 05 0 5 0 05 0 6 aqueous control solution SO296 95 4 0 02 0 1 0 14 0 1 0 14 0 2 All specific performance characteristics tests were run with default instrument calibration an
48. 60825 1 The maximum energy output is as follows 670 nm LED 40 Microwatts max for 400ms 780 nm Laser 40 Microwatts max for 400ms 850 nm Laser 40 Microwatts max for 400ms Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure Operating Safety Information Symbol Definitions The symbols described below are used on the packaging of OPTI CCA TS related products Symbol Explanation m S U gt E LOT C Q9 PFTG Attention Symbol Refer to the Operator s Manual or Service Manual for further instructions This symbol is located on the inside of the instruments and product packaging Expiration Use By Symbol Product to be used by the expiration date indicated to the right of this symbol This symbol is located on all consumables which are controlled via an expiration or use by date Batch Code Symbol Manufacturing lot number is located to the right of this symbol This symbol is located on all products which are controlled via a lot number Do Not Re use Symbol Identifies products which are not to be used for more than the specified period of time as defined in the product instructions This symbol is located on all applicable product packaging Recycle Plastic Symbol Identifies the clear plastic material polyethylene terephthalate glycol used in the packaging of the product Containers ide
49. 9 1 03 1 6 96 96 48 6 7 50 0 0 84 1 4 103 96 75 4 7 75 1 1 04 0 3 100 120 4 9 121 2 2 06 0 8 101 201 3 8 206 3 2 67 5 0 102 96 300 5 9 296 8 4 91 3 7 99 489 4 7 489 5 12 92 0 1 100 499 5 7 485 9 16 22 13 6 97 96 PO2 2 Operator s Manual OPTI CCA TS ANALYTES PO 2 Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods PO linearity is established against values determined on whole blood tonometered to gravimetrically prepared gases with O concentrations certified to 0 03 absolute by the manufacturer and measured on three OPTI CCA TS systems Correlation Slope Intercept Coefficient Sy x Range n 0 9844 1 864 0 99974 4 52 21 500 68 Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9419 3 28 0 9976 18 27 36 563 103 Analyzer B whole blood 1 0192 4 13 0 9969 4 10 34 291 173 0 918 0 0
50. Below is a listing of all necessary supplies and accessories To order replacement supplies and accessories contact your local authorized OPTI Medical Distributor or in the U S call the OPTI Medical Order Entry Department at 1 800 490 6784 OPTI Monday through Friday 8 AM to 5 PM eastern time Our Order Entry representatives will gladly provide any assistance you may require Description Part Number 9 1 Analyzer OPTI CCA TS Analyzer GD7013 with Accessory Kit 9 2 Cassettes OPTI Cassette B 25 per box BP7562 OPTI Cassette E 25 per box BP7587 OPTI Cassette E Ca 25 per box BP7560 OPTI Cassette E Cl 25 per box BP7559 OPTI Cassette E Glu 25 per box BP7564 OPTI Cassette E BUN urea 25 per box BP7588 OPTI Cassette B Lac 25 per box BP7561 OPTI Cassette B60 25 per box BP7586 9 3 Controls Calibrators Standard Reference Cassette SRC Level 1 BP7536 Standard Reference Cassette SRC Level 2 BP7554 Standard Reference Cassette SRC Level 3 BP7543 OPTI CHECK Trilevel HC7008 OPTI CHECK PLUS Trilevel HC7009 tHb Calibrator Cassette BP7542 Operator s Manual OPTI CCA TS 9 1 9 SUPPLIES Description Part Number 9 4 Consumable Items Printer Paper 1 roll HP0070 Calibration Gas Bottle 1 pc BP7001 Capillary Tubes 250 pcs MC0024 Syringe Adapters 250 pcs box BP7600 ComfortSampler with Accessories BP0600 ComfortSampler Basic
51. CCA TS actual 8 9 actual reference ranges A 5 acutal calculation A 9 standard 8 9 standard calculation A 9 standard reference ranges A 5 Blood collection and handling 5 1 8 3 volume required 8 6 Buffer bases 8 9 calculation A 10 reference ranges A 5 BUN Urea Clinical significance BUN 1 Correlation to Other Methods BUN 3 Interferences BUN 2 Linearity BUN 2 Measurement principle BUN 1 Measurement range BUN 1 Reference intervals BUN 2 References BUN 3 Reproducibility BUN 2 SRC Limit Values BUN 2 C Calcium See Ionized Calcium Calculated parameters 3 10 A 7 Calculated values 8 9 A 4 Calibration 4 1 8 9 gas bottle 8 15 report setup 3 24 tHb troubleshooting 7 33 touch screen 7 23 Capillary tubes 8 3 attach sample 5 7 sample collection 5 2 5 10 8 3 Carbon dioxide partial pressure PCO2 clinical significance PCO2 1 correlation to other methods PCO2 3 linearity PCO2 3 measurement principle PCO2 1 measurement range PCO2 1 precision and recovery PCO2 3 INDEX reference intervals PCO2 1 references PCO2 3 reproducibility PCO2 1 SRC limit values PCO2 1 temperature corrected A 12 Chloride CI Clinical significance CL Correlation to Other Methods Cl 3 Interferences Cl 2 Linearity Cl 2 Measurement principle CL Measurement range Cl 1 Reference intervals Cl 2 References Cl 3 Reproducibility Cl 2 SRC Limit Values Cl 1 Classifications A 7 ComfortSamplers 5 2 8 4 Communications
52. CT sensor does exhibit a significant greater than 2 1 positive interference from bromide iodide interlipid and nitrite Minor interference is observed from phenylacetic acid salicyate and thiocynate Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments Chloride values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 1 76 8 0 12 0 2 0 51 0 7 0 53 0 7 Level 2 100 2 0 10 0 1 0 74 0 7 0 75 0 8 Level 3 116 8 0 11 0 1 0 45 0 4 0 47 0 4 Serum 97 6 0 06 0 1 1 03 1 1 1 03 1 1 Reduced Bovine Hemoglobin 79 2 0 07 0 1 0 78 1 0 0 80 1 0 Solution All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at e
53. Cord Scalp Scalp Bypass Off Pump On Pump Off Pump 8 6 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES Parameter Range Default Display Resolution Units Sample Type Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous Mix Ven Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass Total hemoglobin tHb 1 to 26 1 to 260 1 to 16 Mean corpuscular hemoglobin 29 0 to 37 0 concentration MCHC O2 Mode Rm Air Mask T P NC Vent Bag Hood or Other where Rm Air Room Air Mask Mask T P T Piece NC Nasal Cannula Vent Ventilator Bag Bag manual resuscitation Hood Hood FIO 0 2 respiratory quotient RQ 0 Other Other 21 to 1 0 70 to 2 00 P 15 to 40 50 Vent Mode N o SIMV PSV PCV CMV AC CPAP PCIVR or BIPAP where No None Operator s Manual OPTI CCA TS SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation Art 15 0 33 3 Rm Air 0 21 0 84 26 7 No 0 1 0 01 0 1 0 01 0 10 0 1 g dL mg dL mmol L mmHg 8 7 8 OPERATING PRINCIPLES Parameter Range Default Display Units Resolution Tidal Volume VT Minute Volume VE Peak Inspiratory Pressure PIP Plateau Pressure Pplat Pressure Support Value PS Positive End Expiratory Pressure PEEP Continuous Po
54. Diagnostics gt Touch Test Not Ready 10 40 12 Nov Please Verify Touch Calibration Calibrate Defaults H Save Q Up 5 Home T ig 7 32 Perform Touch Test X os Please Touch and Hold Target Fig 7 33 Perform Touch Calibration Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The purpose of this test is to check the proper operation of the touch screen From the Ready display press System Manager gt Diagnostics e Select the Tests tab e Press Touch to start the test Fig 7 31 e Touch the screen and a dot should appear under the touched location Fig 7 32 e f not press lt Calibrate gt to perform a touch calibration e Press UP D return to the lt System gt screen e Using a finger stylus or pointed object e g syringe adapter touch the center of the calibration mark as it moves around the screen Fig 7 33 NOTE Do not use sharp objects since they may damage the screen e When finished press fa Save 7 23 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 19 Gas Test ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics RS232 Flow Pump Display Touch Cor D Lactate Ethemet Setup Q Up Fy Home Fig 7 34 Gas Test 7 24 The Gas Test gt Fig 7 34 is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system NOTE This test
55. High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS K 3 ANALYTES CALCIUM lonized Calcium Car Clinical Significance Calcium in blood is distributed as free calcium ions 50 bound to protein mostly albumin 40 and 10 bound to anions such as bicarbonate citrate phosphate and lactate However only ionized calcium can be used by the body in such vital processes as muscular contraction cardiac function transmission of nerve impulses and blood clotting The OPTI CCA TS measures the ionized portion of the total calcium In certain disorders such as pancreatitis and hyperparathyroidism ionized calcium is a better indicator for diagnosis than total calcium Elevated calcium hypercalcemia may be present in various types of malignancy and calcium measurements may serve as biochemical markers In general while ionized calcium may be slightly more sensitive either ionized or total calcium measurements have about equal utility in the detection of occult malignancy Hypercalcemia occurs commonly in critically ill patients with abnormalities in acid base regulation and losses of protein and albumin which gives a clear advantage to monitoring calcium status by ionized calcium measurements Patients with renal disease caused
56. Ir Ic OS n 3 16 3 3 3 1 Setting up Security ssssssssssesssenee eene nennen nennen enne nnne 3 16 3 3 3 2 Entering the Barometric Pressure dicente pet asec raren di vea dee ea ERR AD uu 3 20 3 3 3 9 Beep Adjustment cer erre tage tes states ee ra d PEE eaa de ette de epa e SE 3 21 3 3 3 4 Battery Saver dae o ced La ee ua ecc dava e vade a ER eo Ti 3 22 3 3 3 5 Setting Up Communtcatons eee 3 23 3 3 3 6 Setting ihe ln TEE 3 25 3 3 3 7 E Ma 3 26 3 3 3 8 Selecting Language EE 3 27 Operator s Manual OPTI CCA TS 3 i 3 1 3 2 3 CUSTOMIZATION CUSTOMIZATION Your OPTI CCA TS analyzer is shipped preset to easily perform sampling operations Through the touch screen you can enter patient data and initiate printing of patient QC and calibration reports as well as enter additional information to tailor the instrument s performance to match the particular needs of your lab For safety and security the OPTI CCA TS customization can be protected by a security code The analyzer s programming or existing parameters can then be changed only by entering the correct security code All system setup selections entered will reside in the instrument memory even after the system power is turned off Data Manager This menu allows you to print out Measurement Diagnostics Reports and Statistics It also provides you with the ability to export information if connected to a computer You can find procedures for pr
57. Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9751 1 623 0 9871 1 16 28 72 103 Analyzer B whole blood 0 9740 2 66 0 9937 1 12 24 92 173 0 988 0 022 0 8074 1 015 0 9750 2 584 23 81 105 1 073 0 011 2 785 x 0 521 0 9910 2 050 17 122 174 1 067 0 009 4 41 0 468 0 9936 1 817 22 120 183 Analyzer C whole blood Analyzer E whole blood whole blood Analyzer D For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Vurek GG Feustel PJ Severinghaus JW A Fiber Optic PCO Sensor Ann Biomed Eng 11 p 499 1983 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS PCO
58. PO by passing a precision calibration gas mixture across the optode sensors The pH and electrolyte channels are calibrated with precision buffer solution contained in the cassette The tHb and SO channels are factory calibrated Operator s Manual OPTI CCA TS 1 1 1 INTRODUCTION 1 3 1 2 When calibration is verified the analyzer aspirates the blood sample into the cassette and across the optode sensors Fluorescence emission is then measured after equilibrating with the blood sample After a single measurement the cassette containing the blood sample is removed from the analyzer and discarded The analyzer contains no reagents blood or waste Contents Before you begin installing your OPTI CCA TS Analyzer take a moment to look over the contents to ensure you have the following Power supply with power cord Battery 2 Standard Reference Cassettes SRC Level 1 and 3 Thermal printer paper tHB calibration cassette You will also need the following consumables prior to setup OPTI sensor cassettes Gas bottle Quality Control Material OPTI CHECK or OPTI CHECK PLUS with glucose or BUN cassettes Operator s Manual OPTI CCA TS 1 INTRODUCTION 1 4 Analyzer Components Before setting up the OPTI CCA TS Analyzer it is important to familiarize yourself with the analyzer s components Printer On Off Switch Touch Screen Display Status Light Sample Measurement Chamber SMC Gas Bottle Ba
59. Pump Motor Test Speed 800 Fig 7 29 Pump Speed 7 2 17 Checking the Display ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics RS232 Flow Pump dum Lactate Setup Ethernet Q Up Home Fig 7 30 Display Test Gas Test 7 22 The purpose of this test is to check the proper functioning of the peristaltic pump motor From the Ready display press System Manager gt Diagnostics e Select the Tests tab e Press Pump to start the test Fig 7 28 e The pump will automatically step through all the speeds used during normal operation 50 to 800 pps pulses per second Fig 7 29 and return to the Tests screen The purpose of this test is to check the proper operation of the display From the Ready display press System Manager gt Diagnostics e Select the Tests tab e Press lt Display gt to start the test Fig 7 30 e The display will turn red green and blue If this is not the case your display is defective and needs to be replaced e Press Up lto return to the lt System gt screen Operator s Manual OPTI CCA TS 7 2 18 Checking the Touch Screen ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics RS232 Flow Pump Display Cron H Gas Test Lactate Setup Ethernet Q Up Fy Home Fig 7 31 Select Touch Test System gt
60. QNext Q Up Za Home Fig 5 22 Calculated results 5 12 When the analysis is completed the status light stops blinking and the instrument alerts you that the measurement has been completed with a beep At this time you may continue entering or editing the patient information until you have completed it or display the results immediately by pressing Q Up at any time If the screen has not been touched for approximately three 3 minutes the results will automatically be displayed Fig 5 21 The second tab displays the calculated parameters Fig 5 22 18 Press Up lto move directly to the next sample display e Ifpatient temperature was input it will be displayed in place of a calculated parameter In this case the blood gas values displayed are temperature corrected e The display will show results according to the type of sensor cassette used See Chapter 9 2 Sensor Cassettes e The resolution of the measured parameters may be configured HIGH Na 156 4 mmol L or LOW Na 156 mmol L in the setup menu See section 3 3 2 6 e The OPTI CCA TS Analyzer flags values that are above or below the programmed ranges with an up or down arrow If the value is outside the measurable range a HIGH or LOW will be displayed and a gt or lt with a range printed out in the message section on the patient report e When a value for any measured parameter can not be determined
61. balance tHb 5 g dL DE 16 2 pH 7 4 24 8 HCO mmol L 7 CLSI Blood Gas and pH Analysis and Related Measurements Approved Guideline NCCLS document C46 A 2001 Operator s Manual OPTI CCA TS A 9 APPENDIX A TECHNICAL SPECIFICATIONS BE aco Base excess at actual oxygen saturation BE gy 1 0 0143 tHb 1 63 tHb 9 5 pH 7 4 24 26 HCO SO BEE J 100 mmol L BB The buffer base is the concentration of buffering anions which is available in whole blood to buffer strong acids and consists mainly of protein anions and bicarbonate Of the protein anions hemoglobin is the most significant BB BE 41 7 0 42 tHb mmol L 5 SO c The oxygen hemoglobin dissociation curve theoretically allows that oxygen saturation of available hemoglobin can be calculated provided the form of the curve is known Factors which are known to affect this curve include hemoglobin species pH PCO temperature and 2 3 diphosphoglycerate 2 3 DPG content Although it is possible to calculate this value the assumptions which are made in the calculation can cause significant errors in the resulting value for those patients who are in the most critical clinical state The OPTI CCA TS has the capability to provide a measured SO from the blood sample It is recommended that this measured value if available should be used in preference to the calculated SO If not available from measurement and if calculation is se
62. basic components of the analyzer and are now ready to install your system Operator s Manual OPTI CCA TS 2 SETUP 2 SETUP EE P 2 1 2 1 Important Safety Instructions eects cece ee eeeeeeeeeeeeeeseeseesssssseeneeeneneeseeeeees 2 1 rA ERE c 2 1 2 3 Setting up the OPTI CCA TS Analyzer REENEN REENEN 2 2 Operator s Manual OPTI CCA TS 2 i 2 SETUP 2 SETUP 2 1 Important Safety Instructions Before you begin installing your OPTI CCA TS Analyzer carefully read the overview information in this chapter For your own safety and the proper operation of your equipment always follow these precautions when working with your OPTI CCA TS Keep the analyzer away from all sources of liquids such as sinks and wash basins Keep the analyzer away from explosive gases or vapors Always handle blood samples and collection devices with care Use approved protective gloves to avoid direct contact with sample Dispose of OPTI Cassette according to local regulations 2 2 Choosing a Location Location is important for trouble free operation of your analyzer Before you begin setup choose a site that is convenient for your sampling needs and meets the following physical requirements of the unit Grounded electrical outlet Away from direct sunlight Room temperature within 10 32 C 50 90 F Maximum relative humidity of 95 Ample room to allow air to circulate around the unit Away from strong
63. by the concentration of the analyte The concentration of the analyte is determined by the calculation of the difference in fluorescence measured at a known calibration point and that measured with the unknown concentration of analyte For a description of the measurement principles of the individual analytes please refer to the analyte section of the OPTI CCA TS Operator s Manual l Guilbault GG Ed Practical Fluorescence 2nd Ed Marcel Dekker 1990 Operator s Manual OPTI CCA TS 8 1 8 OPERATING PRINCIPLES 8 3 Operation The OPTI CCA TS is a microprocessor based instrument measuring optical fluorescence A disposable single use cassette contains all the elements needed for calibration sample measurement and waste containment After scanning the calibration information specific to a cassette into the instrument by holding the cassette package in front of a convenient bar code scanner the cassette is placed into the measurement chamber The analyzer warms the cassette to 37 0 0 1 C and performs a calibration verification on the sensors for PCO and PO by passing a precision calibration gas mixture across the optode sensors The pH and electrolyte channels are calibrated with precision buffer solution contained in the cassette The tHb and SO channels are factory calibrated When calibration is verified the analyzer aspirates the blood sample into the cassette and across the optode sensors Fluorescence emission is then measured
64. calibration instead The battery is low e Install a freshly charged battery or recharge for up to 6 hours before the next sample is run or operate the analyzer on AC power The battery is low e Install a freshly charged battery or recharge for up to 6 hours before the next sample is run or operate the analyzer on AC power e Turn the power off wait 30 seconds and then turn the power back on 7 9 7 DIAGNOSTICS AND TROUBLESHOOTING STOP Low Gas Replace Now STOP Need New SRC Data Must Run SRCs m STOP System Error Cycle Power for Reset STOP Memory Error Database Deleted S Lactate Setup STOP Lactate Setup Required S A STOP Need New QC Data Must Run Controls OK STOP Temperature Out of Range S 7 10 The gas cylinder is empty e Replace the gas cylinder and press OK If SRC QC lockout has been activated in Setup this message will be displayed if SRCs have not been run within the specified time e Press OK and run SRCs The instrument has detected an internal error e Discard the cassette e Turn the power off wait 30 seconds and then turn the power back on Patient QC and other databases were deleted e Press OK Gei the instrument will reinitialize This error message will appear if you try to run lactate cassettes if the lactate parameter has not been set up on your analyzer e Refer to section 7 2 20 for instr
65. collection Erythrocyte aggregation and sedimentaton may occur very quickly in syringes containing pathologic blood samples and may adversely affect the measurement of ctHb in any analyzer To prevent such errors first insert the OPTI CCA TS cassette into the analyzer to initiate calibration Next mix the syringe sample well by rolling the syringe for at least 60 seconds after expelling any trapped bubbles then immediately measure in the OPTI CCA TS The OPTI CCA TS system aspirates blood in the same manner from syringes capillaries or ComfortSampler No changes are made to the aspiration rate volume or timing Therefore there are no biases or imprecision dependent upon the sample introduction method Sufficient volume must however be present in syringes 0 25 mL in a 1 mL syringe to prevent mechanical interference between the syringe plunger and the syringe adapter Errors in blood analysis on properly collected samples may result from improper mixing of the sample after collection and before measurement contamination with room air resulting from failure to expel any trapped bubbles after collection and from metabolic changes in the sample Serum samples should be obtained by collecting blood in an untreated blood collecting tube The sample should stand for 30 minutes to allow the clot to form prior to centrifugation After centrifugation remove the serum from the clot and cap or seal the sample tube If storage is required the samp
66. dL Hb Type Adult S02 90 100 SamType Art MCHC 39 3 O2 Mode Room Air MESSAGES FIO2 0 21 Reminder Run SRCs today RQ 0 84 Operator s Manual OPTI CCA TS D 1 APPENDIX D REPORT FORMATS SRC Measurement Report D 2 E Ca example OPTI Medical OPTI CCA TS SRC Measurement DD MMM YY HH MM Level 3 SRC ID XXXXX R pH d PCO2 2 PO2 17 Na 16 K 7 Ca 0 tHb S02 9 ESULT 601 0 0 0 0 5 1 00 70 8 5 8 6 Exp MMMYY LIMITS 7 580 7 620 18 0 22 0 167 0 173 0 142 148 6 70 7 30 0 60 0 80 Den 9 5 96 0 100 0 SRC Test Result PASS Operator 1D 123456789012 S N 123 456 OOO CO CH CH OO Oo NNNNNNN AN AN fs Operator s Manual OPTI CCA TS DOCOMO PR Ww b Heal a Or O OUT O ob b H w o ob wU OD JJ GA Q A EV CO OO OO OO OO OO OO OO OO OO OO OO OO OH ON ch ON DON ON ON ch ON ON ch ON ON ch ON DON ON ON ch ON ON ch ON ON ch bh cy SRC Statistics Report ABG example OPTI Medical OPTI CCA TS SRC Statistics DD MMM YY HH MM Level 1 SRCID XXXXXXX Exp DDMMMYY S N XXXXX Number run 26 Number ok 26 ABG LIMITS pH 74100 27 150 PCO2 68 0 72 0 mmHg PO2 57 0 63 0 mmHg Date pH PCO2 PO2 08Aug 7 13 67 8 59 09Aug 7 12 72 2 59 10Aug 7 11 69 8 58 11Aug 7 10 69 2 58 12Aug 7 07 67 8 58 13Aug 7 08 67 3 57 14Aug 7 09 67 4 57 15Aug 7 11 71 5 56 16Aug 7 09 68 0 56 17Aug 7 08 68 0 57 19Aug 7 10 68 0
67. electromagnetic fields such as those created by electric motors and X ray equipment Away from explosive gases or vapors Placed on flat surface with ample room between air vents on bottom of unit and surface to prevent unit overheating NOTE Above requirements also apply when the OPTI CCA TS operates on battery power outside a laboratory setting Operator s Manual OPTI CCA TS 2 1 2 SETUP 2 3 Setting up the OPTI CCA TS Analyzer 2 2 You are now ready to prepare your OPTI CCA TS Analyzer for operation Begin by placing the analyzer on a secure table top that allows plenty of working space and is convenient to a power connection 1 Plug in the Power Supply e Plug the power supply into the receptacle on the left side of the unit Fig 2 1 e Plug the power cord into the power supply e Plug the cord into a grounded electrical outlet NOTE To protect your OPTI CCA TS and other electronic devices from damage caused by electrical power spikes OPTI Medical recommends the use of a surge protector Fig 2 1 Power Cord Connection 2 Install the Battery Pack in its Housing e Push the battery pack into the opening on the left hand side of the OPTI CCA TS Fig 2 2 NOTE The battery will need to be charged for at least 6 hours prior to using the OPTI CCA TS on battery power It will be charged automatically whenever the analyzer s external power supply is plugged into an electrical outlet
68. fall within limits supplied with the SRCs Level 1 and level 3 SRCs are supplied with the analyzer producing low and high values for all measured parameters An optional normal range SRC Level 2 is available from OPTI Medical Systems All specific performance specifications reported in this summary are determined from the above minimal recommendations for quality control verification The OPTI CCA TS s equivalent QC method Standard Reference Cassette SRC is a relatively new concept in quality control testing In traditional blood gas analyzers liquid quality control QC material is run several times a day to verify the system measurement including reagents used for patient testing On these systems multiple patient samples are run using the same reagent system The OPTI CCA TS is one of a new generation of systems where all reagents needed to run a single patient measurement are pre packaged in a single disposable cassette Each cassette is an individual reagent and sensor system For SRC limit values see analyte section of this manual The traditional method of running a liquid QC material several times each day does not check these individual reagent and sensor systems Therefore manufacturers have developed equivalent QC methods to ensure all elements of the system are monitored OPTI Medical Systems has a two step approach First the SRC the OPTI CCA TS s electronic optical simulator checks the electronics optics thermostats
69. its pouch immediately after removal from the instrument NOTE Make sure to keep the calibrator cassette d with the instrument at all times Fig 6 10 tHb Calibration 6 4 Operator s Manual OPTI CCA TS 6 MAINTENANCE OPTI Medical OPTI CCA Calibration Report DD MMM YY HH MM S N XXXX Version ABCX XX The unit will now begin printing the tHb Calibration Ee Report showing both the old and new calibration HbCal Type tHb Calibrator b HbCal LOT XXXXXX results and calibration factors Fig 6 11 HbCal Date DD MMM YY Calibration Results Meas d Cal d tHb 12 9 13 0 S02 74 6 74 9 Calibration Factors OLD NEW F1 1 023 1 014 F2 1 087 1 080 F3 1 089 1 094 F4 0 000 0 000 Fig 6 11 HbCal Report p uuu 13 After completion of Hb Calibration it is Delete old SRC Data and necessary to delete and reload the current SRC esos aoe data for each level Refer to section 3 3 1 1 ek Setting up the Standard Reference Cassette 14 Press Fig 6 12 to proceed to the lt SR gt Fig 6 12 Delete and rescan SRC data SRC Setup menu 15 Verify performance by now running SRC measurements and 3 levels of OPTI Check Operator s Manual OPTI CCA TS 6 5 6 MAINTENANCE 6 3 2 Performing HbCal Last Blood Not Ready 10 40 12 Nov Control SRC tHb Calibrator Qu Fy Home Fig 6 13 Select tHb Calibrator QC gt tHb Ready 10 40 12 Nov Select tHb C
70. keypad to type in the desired information Press x to save the information entered Pressing 2 Next wil access subsequent patient data entry screens Fig 5 15 tHb default value 15 0 g dL FIO default value 0 21 MCHC default value 33 3 RQ default value 0 84 P default value 26 7 mmHg 5 9 5 SAMPLE HANDLING AND PATIENT TESTING iMeasurement gt Patient Data Measuring 10 40 12 Nov tHb Type Adult Fetal c c e Sample Type e An Ven MixVen rs c c Cord CPB Cap c c Cc Puncture Site LR RR LB RB Cc Cc Cc c LF RF Cord Scalp Cc Cc Cc e G Back Page 3 of7 Next 6 Finish Fy Home ox e Fig 5 16 Edit patient data 3 IMeasurement Patient Data Measuring 10 40 12 Nov Vent Mode No SIMV PSV PCV e E c e c CMV AC CPAP PCIVR BIPAP c e E c 02 Mode RmAir Mask TP NC c Cc Cc Cc Vent Bag Hood Other Cc c C Bypass o pump Se om Page 4 of7 e E Finish Fy Home Fig 5 17 Edit patient data 4 5 10 12 Press Next again and the following patient information is displayed Fig 5 16 Hb Type adult or fetal default is adult Patient Sample Type Art Ven MixVen Cap Cord CPB where Art Arterial Ven Venous Mix Ven Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass Puncture Site LR RR LB RB LF RF Cord Scalp where LR Left Radial LB Left Brachial LF Left Femoral Cord Cord RR Right Radial RB Right Brachial
71. leave the default time and date setting unchanged or press the Edit button to call up a numeric keypad that can be used to change the time and date setting To change the Time Format from lt 12 hour gt time units to lt 24 hour gt time units press the respective radio button Select Automatically Adjust for Daylight Savings if you want the system clock to change to Daylight Savings Time automatically To change from Standard Time to Daylight Savings Time manually select the option Daylight Savings Enable Press S9 to accept the changes Press Q Up lto return to the lt System gt screen or Home to return to lt Ready gt Setup menus let you set up quality control materials program the setup of the printed reports set up system security and customize several other system features 1 From the Ready display press System Managers to access the System menu Press Setup to select this function Fig 3 5 Enter the password 404 to access the setup functions NOTE You may not be prompted to enter a password if the password was previously disabled see Section 3 3 3 4 1 NOTE If the factory set password was changed enter the currently valid password Operator s Manual OPTI CCA TS 3 3 1 QC Setup 3 CUSTOMIZATION 3 3 1 1 Setting Up the Standard Reference Cassette SRC Not Ready 10 40 12 Nov Patien OC Miscellaneous ac Control Customizing Patient I
72. paper into the feeder slot as shown in the diagram on the analyzer Fig 2 11 e As soon as the printer detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if paper is present e To advance paper after the initial installation press the red paper advance button located on the left side of the printer Fig 2 12 NOTE The red paper advance button is only active when the printer detects paper in the printer Fig 2 12 Paper Advance Button 2 6 Operator s Manual OPTI CCA TS Not Ready 10 40 12 Nov Control SRC tHb Calibrator e ti e Up Fy Home Fig 2 13 Select tHb Calibrator Enter Password 7 8 9 EE 2 3 0 mul IP Fig 2 14 Enter Password Enter Operator ID id fes e ra nd M asd Ex pe as ra Fe 8 o E ul oJ Fi eal Feld a Fe Pa ES ol eal s e Ir x x SS d Fig 2 15 Enter Operator ID Operator s Manual OPTI CCA TS 2 SETUP Performing tHb Calibration The tHb Calibrator Cassette should be run prior to patient testing when first setting up your analyzer The tHb calibrator should then be run quarterly Your OPTI CCA TS will remind you when the tHb calibration is due The tHb Calibrator Cassette can be found in the storage compartment in the back of your analyzer e Inthe Ready
73. port These ports may be configured for ASCII and ASTM output 1 From the lt Ready gt display select System Manager and Setup In the System Setup menu press the Miscellaneous tab and then Hardware In the Interface screen Fig 3 39 you can select External Barcode Enable Select the communication Format lt ASCII gt lt ASTM gt or CF lt ASCII gt Data in easy to read OPTI Medical custom format The OPTI CCA TS exports data string identical to the internal printer output lt ASTM gt Complies with ASTM standard Please refer to OPTI CCA TS interface specifications for more information lt CF gt Compact Flash is used for archiving data to a Compact Flash Card An Export Kit is available BP7140 with a properly formatted card instructions and card reader The database can be exported to the Compact Flash card in CSV format and then read by a PC Select Comma or lt Semicolon gt for your CSV file delimiter in MS Excel Link Select Serial or Ethernet The Ethernet screen Fig 3 40 is used to configure Ethernet settings Format IP Type IP Address lt Subnet Mask gt UDP Portz lt TCP Port gt and Host IP NOTE The analyzer must be connected to an active network to activate this menu 3 23 3 CUSTOMIZATION 3 24 iSystem gt Diagnostics gt Ethernet Not Ready 10 40 12 Nov Connection Status Connected D
74. production include a high protein intake gastrointestinal bleeding with absorption of amino acids and peptides or increased tissue breakdown which may be due to serious illness trauma or certain drugs such as tetracyclines and glucocorticoids Decreased excretion is associated with a low glomerular filtration rate GFR This can be due to a number of reasons which can be classified as pre renal uraemia due to dehydration renal uraemia due to intrinsic failure in the kidney or postrenal uraemia due to an obstruction to urine outflow Causes of low blood urea levels 2 1 mmol L urea 6 mg dL BUN These are less common than high levels and can be due to decreased production or increased excretion Decreased production can be due to ingestion of a low protein diet very severe liver failure and in infants only inborn errors of the urea cycle Increased secretion is due to an increased GFR This can be due to over enthusiastic infusion of intravenous fluids inappropriate ADH secretion or pregnancy Measurement Principle The BUN urea optode measurement is based on the enzymatic hydrolysis of urea by the enzyme urease Urea H O 2H 2 NH CO Urease The ammonium ions are measured by an ammonium selective fluorescence based optical sensor optode The amount of urea present is proportional to the ammonium concentration detected Measurement Range Range Resolution Low High Units BUN 2 8 to 112 0 0 1 mg dL Urea 1
75. run controls prior to running patient samples on a new analyzer You must set up your SRCs and OPTI Check control lot information in your new analyzer prior to running them The SRCs can be found in the storage compartment in the back of your analyzer Refer to section 3 3 1 of this manual for the QC Setup procedure Refer to section 4 5 of this manual for QC recommendations and instructions for running QC measurements Congratulations Your OPTI CCA TS analyzer is now ready for operation Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 CUSTOMIZATION E 3 1 31 tere Metteg 3 1 42 Setting Time and Date racic irte Exe upon apo tus toon nS Rupee EE EE E tu bU E EE DU E UdE 3 1 33 3 2 SE A MEO CSI I EECH 3 3 3 3 1 1 Setting Up the Standard Reference Cassette RBC 3 3 3 3 1 2 Setting up the Quality Control Material Lot and Level 3 4 3 3 2 Customizing Patient InfOrmatiOrtsussss prn gt FEaEeSeue e pvx s a iias KE 3 7 3 3 2 1 Selecting Which Patient Information is Requested and Printed sssssssss 3 7 3 3 2 2 Selecting Which Parameters Are BlankediDtsabled 3 9 3 3 2 3 Selecting Which Calculated Parameters Are Printed seeeessseessrrsseesrreeersrrssseernneersna 3 10 3 3 2 4 Setting Normal Ranges or Alarm Limits sss m 3 11 23 3 2 5 Seting up Correlation F actors ete ene ed ti ee o aede ud 3 13 3 9 2 6 Defining UNIS E 3 14 Der
76. ss ceeds 3 1 3 2 Setting Time and Date ettet dta eee eee eee 3 1 2 0 0 recen 3 2 391 QC SEUD ME 3 3 3 3 1 1 Setting Up the Standard Reference Cassette SRC usssesssseesssrresererreserenrssserrnneesennns 3 3 3 3 1 2 Setting up the Quality Control Material Lot and Level 3 4 3 3 2 Customizing Patient Informatio EE 3 7 3 3 2 1 Selecting Which Patient Information is Requested and Printed sssssssss 3 7 3 3 2 2 Selecting Which Parameters Are BlankediDtsabled 3 9 3 3 2 3 Selecting Which Calculated Parameters Are Printed eeesseeeseeeeseeerresserrrsssrerrrssenes 3 10 3 3 2 4 Setting Normal Ranges or Alarm Limits ss 3 11 3 3 2 5 Setting up Correlation Factors ecce hentai nena RR Mann Ru ndn 3 13 3 9 2 6 Defining ET 3 14 Operator s Manual OPTI CCA TS TABLE OF CONTENTS 329 3 Creole TE 3 16 3 3 3 1 Setting Up SeCcuUrliy coiere ic rr det epa rcu teeta pitted aan cece eA el 3 16 3 3 3 2 Entering the Barometric PressU re iet renati eden d niu LR 3 20 3 3 3 3 Beep Et 3 21 ERE Eius EE 3 22 3 3 3 5 Setting Up Communications 0 0 0 cee cee eee ett ee terete tere eene eene 3 23 3 3 3 0 Setting the Printer oisi mee nt EE D Te E ERREUR E 3 25 33 3 7 Maitena NCE m Is 3 26 3 3 3 8 Selecting a Language roii ek eoa ci th EAEN F a cR EEEE EEEE 3 27 4 CALIBRATION AND QUALITY CONTROL
77. to a number of causes which can be subdivided into those due to diabetes mellitus or those due to non diabetic causes Diabetes mellitus is a syndrome of chronic hyperglycaemia which is due to either absolute insulin deficiency or reduced tissue response to insulin or both It is a common condition which is diagnosed according to strict criteria that rely upon measurement of the blood glucose level Nondiabetic causes of hyperglycaemia include postprandial occurs immediately after a carbohydrate containing meal factitious blood taken from an arm where glucose is being infused drugs produce a tissue insensitivity to insulin non pancreatic endocrine disease excessive production of anti insulin hormones pancreatic disorders secondary diabetes mellitus and stress physical and psychogenic types causing excess secretion of cortisol and catecholamines Hypoglycaemia is an acute medical condition with a number of characteristic signs and symptoms which are accompanied by biochemical hypoglycaemia and which are relieved by the administration of glucose The causes of hypoglycaemia can be divided into three groups medication toxins reactive hypoglycaemia and fasting hypoglycaemia Hypoglycaemia due to excessive amounts of certain medications or toxins include insulin insulin overdose is the most common cause of hypoglycaemia oral hypoglycaemic or sulphonylureas ethanol and other drugs such as salicylate and propanalol Reactive Hypoglycaemi
78. will last 2 hours It can only be interrupted by switching the analyzer off Operator s Manual OPTI CCA TS 7 2 20 Lactate Setup ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics RS232 Flow Pump Display Touch Gas Test Lactate es k Q Up Fy Home Fig 7 35 Lactate Setup Enter Operator ID ia per ns d s ET Tee d e 13 ect Pad ena EA Fs Fe e e ur ceo wl xe Cancel Ok Fig 7 36 Enter Operator ID ISystem Diagnostics Lactate Setup Run new Level 2 Control Using a new vial Lactate Setup Lactate Setup is complete Are you sure you want to reset Yes No Completed 2 of 8 ox Fig 7 37 Lactate Setup 7 DIAGNOSTICS AND TROUBLESHOOTING The lt Lactate Setup gt menu is used to enable the running of lactate cassettes New analyzers from OPTI Medical are already set up for the lactate parameter and do not require this step Only follow this procedure if you wish to set up B Lac cassettes The lactate setup procedure only has to be performed once on your analyzer The setup will permanently enable B Lac cassettes on your analyzer The setup is not cleared by power loss software upgrades reset or otherwise clearing the analyzer s database This is not a troubleshooting procedure Call Technical Support for further assistance From the Ready display press System Manage
79. 0 005 0 7 0 005 0 7 Serum 0 64 0 001 0 1 0 01 1 8 0 01 1 8 Reduced Bovine Hemoglobin 0 81 0 001 0 2 0 007 0 9 0 007 0 9 Solution All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Ca 2 Operator s Manual OPTI CCA TS ANALYTES CALCIUM Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Ionized calcium linearity is established by measurement of gravimetrically prepared N I S T traceable aqueous standard solutions ionized calcium and by measurement of N LS T Standard Reference Material 956a Electrolytes in Human Serum ionized calcium isr Correlation Slope Intercept Coefficient Sy x Range n ionized Calcium 1 0022 0 0025 0 99983 0 017 0 2 3 0 24 ionized Calcium 0 9938 0 0081 0 99843 0 016 1 07 1 71 12 NIST Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was
80. 0 800 E Glu Home offset 240 pH PCO2 PO2 Na PHR Correction 160 K Glu tHb S02 PCR Correction 75 E BUN GAS Opsi 441 pH PCO2 PO2 Na GAS 140psi 3611 K BUN tHb S02 pH Dry Scalar 0 000000 Printer Fix No Calculated Parameters Laser Parameters B HbCal Life 3 BE tco2 HCO3 WQC SETTLE 0 1000 st HCO3 Hct c WQC NU 2715 B Lac SAM SETTLE 0 1000 BE tCO2 HCO3 SAM NU 45 St HCO3 Hct c Kl 3 5711 Fl 0 9717 B 60 K2 3 2248 F2 1 0010 BE tCO2 HCO3 K3 0 8407 F3 0 9825 st HCO3 K4 9 2500 F4 0 0000 E K5 17 5040 F5 0 0000 BE tCO2 HCO3 K6 5 0090 F6 7 9000 St HCO3 Hct c K7 12 3660 F7 44 7000 E CI K8 121 3850 F8 11 4000 BE tCo2 HCO3 K9 0 1321 F9 41 4000 St HCO3 AnGap K10 0 1428 F10 15 8000 E Ca K11 0 0040 FIL 2 0000 BE tCo2 HCO3 K12 1 2586 F12 48 5000 St HCO3 Hct c Operator s Manual OPTI CCA TS D 7 APPENDIX D REPORT FORMATS Maintenance Report OPTI Medical OPTI CCA TS MAINTENANCE REPORT DD MMM YY HH MM S N XXXX Version ABCX XX DDMMMYY HH MM Pump Replaced DOM0213D DDMMMYY HH MM Cleaning Completed D 8 Operator s Manual OPTI CCA TS Error Report OPTI Medical OPTI CCA TS ERROR Report DD MMM YY HH MM S N XXXX Version ABCX XX DDMMMYY HH MM ERROR Cassette Misseat 1 DDMMMYY HH MM ERROR Cassette Misseat 2 DDMMMYY HH MM ERROR Gas Expired DDMMMYY HH MM Warning B
81. 1 7 520 NO 7 170 NO Methylene Blue 0 125 mM 7 520 0 033 7 170 NO Sodium Chloride 20 mM 7 520 NO Operator s Manual OPTI CCA TS ANALYTES pH Dry Sensor The following samples were identified as interfering with the dry pH sensor in the interference study performed for the OPTI LION 510 k submission Interferent Test Level Change Sodium Bisulphate 11 5mM 0 16 Phenylacetic Acid 10 0mM 0 12 Methylene Blue 25mg dL Unstable Fluorescein 25mg dL Unstable Reproducibility Controls Within Run Swr and Total ST Precision were determined from 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for three different lots of B Lac cassettes are shown below Material mean Lot 1 Lot 2 Lot 3 OPTI CHECK Swr ST Swr ST Swr ST aqueous control solution Level 1 7 17 0 011 0 014 0 008 0 007 0 005 0 006 Level 2 7 44 0 010 0 010 0 010 0 010 0 004 0 005 Level 3 7 65 0 011 0 011 0 007 0 007 0 004 0 006 Whole Blood Within Run precision in whole blood samples was evaluated at three different pH concentrations using multiple instruments and multiple cassette lots pH in Whole Blood Level 1 Level 2 Level 3 Average 7 170 7 306 7 610 St Dev 0 008 0 007 0 011 9o CV 0 1296 0 1096 0 1496 n 18 18 18 Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established
82. 1 5 Capillary TUDES T 5 2 5 1 6 OPTI Medical ComtortGamplers memes 5 2 5 1 7 Handling and Storage of Samples E 5 3 5 1 8 Test Conditions ee 5 4 52 Sample Pre Par alm E 5 4 5 2 1 Whole Blood Samiples ener enter t e oe e EC EY DR EO E EYE a 5 4 5 3 Running A Patient Sample eeeeeeeeeeeeeeeennennnnnnnnnnnnnnnnnnnnn 5 5 5 4 Printing Patient El tte rhet E pnta a eere areae Eos e Exe Ee E EE EFE FRAIS 5 14 Operator s Manual OPTI CCA TS 5 i 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING The OPTI CCA TS Analyzer provides fast and convenient measurement of pH PCO PO Nat K Ca Cl Glu BUN urea Lac tHb and SO in whole blood and pH Na K Ca CI Glu and BUN urea in serum and plasma The analyzer will accept specimens directly from most syringes capillary tubes and the OPTI Medical ComfortSampler through the fillport on the OPTI Cassette NOTE Always follow proper safety procedures when handling biological samples 5 1 Specimen Collection and Handling 5 1 1 Safety Universal precautions must be observed when collecting blood specimens It is recommended that all blood specimens be handled as if capable of transmitting human immunodeficiency virus HIV hepatitis B virus HBV or other bloodborne pathogens Proper blood collection techniques must be followed in order to minimize risk to th
83. 1 Checking the Bar Code Scanner ISystem Diagnostics NA Ier 100 NON This option allows you to check the function of the seneg control SR bar code scanner Barcode muri 21 From the Ready display press lt System Manager and Diagnostics RS232 Flow Pump L e Select the Tests tab Display Touch Gas Test Lactate Setup Ethernet Q Up f Home e Press Barcode to start the test Fig 7 12 Fig 7 12 Barcode Test e To test the bar code scanner scan a bar code label of e g a sensor cassette Fig 7 13 e The display will show a sequence of numbers Fig 7 14 Compare the numbers with those printed on the cassette bar code label Matching information confirms the proper function of the bar code scanner Scan Barcode Fig 7 13 Scan Barcode Barcode Test 012345678901234567890123456789 e Press Q ER lto return to the lt System gt screen e Press OK lo return to the Tests screen Fig 7 14 Barcode Test Operator s Manual OPTI CCA TS 7 17 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 12 Checking the Printer ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode C rm Optics RS232 Flow Pump Display Touch Gas Test Lactate Setup Ethernet Q Up Home Fig 7 15 Printer Test 7 18 This diagnostic function lets you check for the proper functioning of the built in thermal printer To activate From the Ready display pres
84. 2 scan the new gas bottle bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer Fig 6 21 Select New Gas Bottle e The red line from the barcode scanner Scan Barcode for New Gas Bottle s should cover the entire barcode Manual Cancel e The analyzer will beep when the barcode is accepted Pig Bee Scan Bar Gode e The barcode can be found on the gas bottle instructional insert Gass e Record the date of installation on the gas ODD Eds bottle for later reference NOTE To enter the bar code manually press v 1208 Manual and enter the bar code using the numeric keypad NOTE The gas bottle should always be stored with the cap on Fig 6 23 Insert Gas Bottle NOTE The bar code contains expiration P 4 information The OPTI CCA TS will alert oo A the operator two weeks before the gas bottle expires J L 5 Press OK ro install the new gas bottle a Fig 6 23 6 Insert the bottle into its housing and turn it Fig 6 24 Gas Bottle clockwise until finger tight Fig 6 24 Operator s Manual OPTI CCA TS 6 9 6 MAINTENANCE New Gas Bottle Fig 6 25 New Gas Bottle Purging Gas Fig 6 26 Purging Gas 2 Weeks Gas Bottle in Use 7 8 9 MR Cs NA ES cid ca 0 Suc Ins OK Fig 6 27 Enter Number of Weeks in use Gas 83 Scan Cassette Barcode L Baro 732 4 Ze
85. 2 3 ANALYTES PCO Dry Sensor PCO Dry Sensor B Lac Cassette Clinical Significance The PCO value of arterial blood is used to assess how well the body eliminates carbon dioxide a by product of metabolism A PCO value below the normal range is termed respiratory alkalosis and indicates hypocapnia a condition caused by increased alveolar ventilation such as hyperventilation An arterial PCO above the normal range is termed respiratory acidosis and indicates hypercapnia a sign of ventilatory hypoventilation and failure resulting from cardiac arrest chronic obstructive lung disease drug overdose or chronic metabolic acid base disturbances Measurement Principle The PCO sensor measurement principle is based upon placing a pH optode behind a gas permeable membrane to measure a hydrogen concentration change in the internal solution when CO permeates through the gas permeable membrane The reaction sequence is outlined below CO H O H CO H HCO The hydrogen concentration change is measured by an optical pH sensor The change in the hydrogen ion concentration is proportional to the carbon dioxide partial pressure in the specimen Measurement Range Range Resolution Low High Units 10 to 200 1 0 1 mmHg 1 30 to 26 66 0 1 0 01 kPa Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 70 0 2 40 0 2 20 0 2 mmHg 9 33 0 27 5 33 0 27 2 67 0 27 kPa Operator s Manual
86. 2 Ethernet accessories Fig 1 9 Compartment Port LED Port Seen e A Compact Flash Card slot CF Slot for software updates and data archiving Fig 1 9 Back of the OPTI CCA TS Battery Pack On the left side of the unit is the rechargeable battery pack It is removed by squeezing the handle N and sliding it out Fig 1 10 The battery allows you san ou to operate the OPTI CCA TS without having to plug the unit into an electrical outlet The battery may either be charged in the OPTI CCA TS unit or independently in the optional Battery Charger Part number BP7036 Fig 1 10 Battery Pack Operator s Manual OPTI CCA TS Power Connector and On Off Switch Era A Fig 1 11 Power Connector and On Off Switch 1 5 Consumables OPTI Sensor Cassette Fig 1 12 OPTI Sensor Cassette Sample Fillport and Syringe Adapter es Qa Fig 1 13 Sample Fillport and Syringe Adapter Operator s Manual OPTI CCA TS 1 INTRODUCTION Next to the battery pack is the power connector where you can connect the OPTI CCA TS to an external power supply Fig 1 11 The On Off switch is located on the left side of the unit next to the power connector Fig 1 11 NOTE Allow a 30 second delay when switching the power ON OFF The self contained OPTI Sensor Cassette has an integral valve with a reservoir The valve seals away the sample after measurement allowing safe clean sample disposal Fi
87. 2402 0 gt E 8 2 8 4 Specimen Collection and Handling eese 8 3 LIONE o rrr Cr TEC 8 3 8 4 2 Sample Requirements e t a ph Hu c d RR E RR EE 8 3 8 4 8 Anticoagulants and Sample Collection Devices eese 8 3 e MEC EET Dr 8 3 8 4 5 Capillary UH 8 3 8 4 6 OPTI Medical ComtortGamplers sss 8 4 8 4 7 Handling and Storage of Samples io orit eet rta debe Ra EI toS eo ieee 8 4 8 5 ENEE 8 5 8 5 1 Materials INeed6ed oii rer reri e e ace ien ren oo a o ren er da Todos uia ens 8 5 9 9 2 TES ene ue In EE 8 6 8 5 3 Input Values ee 8 6 8 54 Calculated Values ierit p t AR a c e FN A RE RR RR RU RR AEN ER 8 9 E Galibraton e n EN 8 9 T ES COMMON LS 8 10 8 5 7 Reference Intervals ssssssssssssssssssssssssseeseeeeeee nennen rrr rrr rne rne rnna 8 11 8 5 8 Specific Performance Characherisice rtnn rtnn rtnn nnen n nennen 8 11 8 99 STIR RE 8 12 LAN Ee 8 13 8 5 11 Accessories c cece cece cece cece cece ee ee cee cece eee cee e eee ttrt ce eeeeeeeeeeeeeeeeeseeeeeeeteeeeeeeseeeeeesseeereeee 8 14 IV Operator s Manual OPTI CCA TS TABLE OF CONTENTS 9 SUPPLIES pac T 9 1 91 Analyze m cerco 9 1 92 sci Scot ecg ee ect ecg es te eens cee 9 1 9 3 Controls CallDEafOIs iaceo coe oe coh ER Exo pO 509220 n2 EP a EE eae Ea cE vu CE RE ERE E EM D RE 9 1 CR Consumable NCSU iss cs dacs et
88. 5 5 kg Classifications Approvals UL3101 1 CAN CSA C22 2 NO 1010 1 CE FCC Class A Mode of Operation Continuous Operation Laser Classification This device is a Class 1 laser device according to IEC 60825 1 Explosion Protection This device is not designed for operation in explosive environments Calculated Parameters The calculated parameters in the OPTI CCA TS are based on the CLSI Standard C12 A when available Temperature 9 tlor T ec 32 T c rer 32 oln t Burtis AB Ashwood ER Tietz Textbook of Clinical Chemistry 2 Ed Philadelphia W B Saunders 1994 p 2165 Operator s Manual OPTI CCA TS A 7 APPENDIX A TECHNICAL SPECIFICATIONS Units Used in Measured and Input Parameters for Calculations DH esc us pH unit Clauses mmol L PCO 4 iecs mmHg Glue mmol L PU aps mmHg BUN mg dL N dioieseenemis mmol L ga estes mmol L mmol L US Le g dL ec mmol L E E Conversion Table for Units ctO O ct tCO 1 vol 1 ml dl 0 4464 mmol l tHb 1 g dl 10 g l 0 6206 mmol l barometric pressure PCO PO 1 mmHg 1 3333 mbar 0 1333 kPa ionized Calcium Ca 1 mmol L 4 008 mg dL 2mEq L glucose 1 mmol L 18 02 mg dL 1 mg dL 0 0555 mmol L BUN urea 1 mmol L urea 2 801 mg dL BUN Lactate 1 mmol L 9 01 mg dL 1 mg dL 0 111 mmol L Equations cH Concentration activity of hydrogen ions in plasma cH 2 10077 nmol L st pH Standard pH o
89. 56 20Aug 7 11 68 1 55 21Aug 7 12 68 8 55 22Aug 7 13 69 3 55 23Aug 7 12 70 1 54 24Aug 7 11 70 2 54 25Aug T710 70 5 53 26Aug 7 10 71 5 53 27Aug 7 11 68 0 54 28Aug 7 11 71 8 54 29Aug 7 12 72 7 55 30Aug 7 13 72 7 55 31Aug 7 13 72 5 56 OlSep 7 11 71 1 57 O2Sep 7 12 72 1 58 O3Sep 7 11 72 1 57 Mean 7 107 70 0 56 SD 0 015 1 9 CV 0 21 2 8 Operator s Manual OPTI CCA TS APPENDIX D REPORT FORMATS D 3 APPENDIX D REPORT FORMATS Controls Measurement Report E Ca example OPTI Medical OPTI CCA TS Controls Measurement DD MMM YY HH MM Level 2 OPTI check Sample No 2345 QCLot 1234 Exp MMMYYYY RESULT LIMITS OK pH 7 551 7 48 7 56 OK PCO2 69 8 65 75 OK PO2 99 8 96 105 OK Nat 144 2 142 148 OK K 4 46 4 0 4 8 OK Ca 1 10 1 091 52 OK tHb 14 7 14 0 15 3 OK SO2 98 3 96 99 OK Control Test Result PASS Store to Database YES Barometer 744 5 mmHg Operator ID 12345678901 S N 1234 Lot 123456 D 4 Operator s Manual OPTI CCA TS Controls Statistics Report ABG Cassette example OPTI Medical OPTI CCA TS Controls Statistics DD MMM YY HH MM Level 1 OPTI check OCLOt XXXX Exp MMMYY CassLot XXXXXX S N XXXX Number run 26 Number ok 26 ABG LIMITS pH 7 070 7 130 PCO2 63 0 77 0 mmHg PO2 60 0 80 0 mmHg Date pH PCO2 PO2 OK 08Aug 7 123 71 5 73 6 OK 09Aug 7 113 73 6 74 5 OK 10Aug 7 090 76 2 73 7 OK 11Aug 7 101 70 3 75 2 OK 12Aug 7 123
90. 6 3 Quarterly Maintenance in this manual QC Overview The intent of a Quality Control program is to assure reliable patient values over the clinically significant ranges for all the measured parameters The program should involve the total process of specimen collection preparation and results analysis reporting and interpretation and the training of personnel involved in all of these processes A Quality Control program for blood gas analysis includes the analysis of materials with known values or ranges of expected values and the comparisons of the results from the analyzer with these values This program allows the analytic performance of a laboratory to be evaluated and documented Operator s Manual OPTI CCA TS 4 1 4 CALIBRATION AND QUALITY CONTROL 4 3 4 4 4 2 An effective Quality Control program should include e evaluation of precision over the entire analytical range e an assessment of failure modes and their effects and means of management throughout the process e simple statistical calculations which provide a means of assessing precision e control charts or graphs which contain warning limits to assist the technical staff in the evaluation of results e a clear set of guidelines to assist the staff in determining if patient results are acceptable e aclear set of corrective actions to be taken in out of control situations Proficiency Testing Proficiency testing complements the above Quality Co
91. 67 8 68 0 OK 13Aug 7 101 69 7 66 8 OK 14Aug 7 076 67 9 75 9 OK 15Aug 7 080 73 7 78 5 OK 16Aug 7 093 72 5 66 3 OK 17Aug 7 099 71 5 69 0 OK 18Aug 7 105 73 5 68 1 OK 19Aug 7 119 76 7 70 7 OK 20Aug 7 104 69 3 77 6 OK 21Aug 7 098 67 0 65 9 OK 22Aug 7 079 66 9 77 0 OK 23Aug 7 084 70 5 62 9 OK 24Aug 7 123 70 2 77 7 OK 25Aug 7 078 73 9 68 9 OK 26Aug 7 129 71 9 67 0 OK 27Aug 7 109 71 5 62 8 OK 28Aug 7 103 64 8 78 6 OK 29Aug 7 113 69 9 70 2 OK 30Aug 7 107 71 9 79 0 OK 31Aug 7 093 67 8 67 6 OK O1lSep 7 079 75 2 78 0 OK 02Sep 7 083 74 2 78 9 OK Mean 7 123 69 7 73 6 SD 0 017 1 6 1 2 CVS 0 235 0 3 0 4 Operator s Manual OPTI CCA TS APPENDIX D REPORT FORMATS D 5 APPENDIX D REPORT FORMATS Configuration Report Part 1 NOTE The values and settings shown are for example purposes only Please refer to your particular analyzer s configuration report for its correct values and settings OPTI Medical OPTI CCA TS Reference Limits For Research Use Only NE a EE mia NO for use rn PO2 70 0 700 0 mmHg diagnostic procedures Na 135 0 145 0 mmol L Configuration Report K 3 50s 5 10 amas i POs HEM ci 95 115 0 mmol L S N XXXX Ca 1 12 1 32 mmol L Version ABCX XX Glu 60 0 120 0 mg dL BUN 5 9 19 9 mg dL Baro Factor 0 0 mmHg lac 0 S0 1 70 mmol l l tHb 12 0 17 0 g dL EE INEO SO2 90 0 100 0 Pat ID ON Opt C
92. 7 Analyzer D plasma 0 971 0 27 0 9822 0 98 5 42 50 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tietz Burtis C Ed Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 p 802 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS BUN 3 ANALYTES LACTATE Lactate B Lac Cassette Clinical Significance Lactic Acid is produced as an intermediate in carbohydrate metabolism The blood lactate concentration is primarily related to the rate of lactate production in white skeletal muscle the brain renal medulla and erythrocytes and the rate of lactate metabolism of the liver and kidneys High lactate levels coupled with a pH of less than 7 25 may indicate Lactic Acidosis Lactic Acidosis has two clinically significant types 1 hypoxic which is associated with lowered availability of oxygen to the body tissues and 2 metabolic which is associated with disease drugs toxins or inborn metabolic issues Hypoxia is the most common cause of the lactic acidosis and may indicate sepsis shock hypovolemia hypo perfusion and left ventricular failure Types of hypoxia include e A
93. 8 13 211 Security Password ENABLED QC Lockout SRC Levels 0 QC Levels 0 New Lot OFF Miscellaneous Units Units Conventional Temp Celcius Time 24 hour tHb g dL Ca mmol L Glu mg dL BUN mg dL Lac mmol L Resolution High Correlation Factors Normal Cassettes Slope Offset pH 1 000 0 000 PCO2 1 000 0 0 PO2 1 000 0 0 Na 000 0 0 K 000 0 00 Cl 000 0 0 Ca 1 000 0 00 Glu 1 000 0 0 BUN 1 000 0 0 Lac 000 0 0 tHb 000 0 0 S02 1 000 0 0 Hardware Ext Barcode OFF CF Delimiter Operator s Manual OPTI CCA TS APPENDIX D REPORT FORMATS Configuration Report Part 2 Communications E Glu Baud 9600 BE tCo2 HCO3 Format RS232 ASCII St HCO3 Hct c Link RS232 E BUN Language English BE tCo2 HCO3 Battery Saver St HCO3 Hct c AutoOff Always On Display Always On FSET Values Measured Parameters System Version 3 00 0037 Blanking OFF GUI App 3 00 0037 B CCA App 3 00 0037 pH PCO2 PO2 tHb GUI Boot 3 00 0000 S02 CCA Boot 3 00 0001 B Lac IDAC1 1464 pH PCO2 PO2 Lac IDAC2 2024 tHb SO2 IDAC3 708 B 60 S N XXXX pH PCO2 PO2 pH False 583 E O2 False 2116 pH PCO2 PO2 Na CO2 False 663 K tHb S02 Ca False 1855 E Cl K False 9151 pH PCO2 PO2 Na Na False 2335 K Ek tHb SO2 Low Limit 278 E Ca Up Limit 1985 pH PCO2 PO2 Na Low offset 500 000 K Ca tHb SO2 Up factor
94. 87 8 083 1 402 0 9954 8 032 29 407 105 1 041 0 006 6 244 x 0 931 0 9969 6 379 37 598 174 0 993 0 009 1 646 0 893 0 9925 4 458 34 322 183 Analyzer C whole blood Analyzer E whole blood whole blood Analyzer D For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Kautsky H Quenching of Luminescence by Oxygen Transactions Faraday Society 35 p 216 1939 3 CDL 3M Healthcare System 200 Extracorporeal Blood Gas Monitor See for example Lubbers DW Gehrich J Opitz N Fiber Optics Coupled Flourescence Sensors for Continuous Monitoring of Blood Gases in the Extracorporeal Circuit Life Supports Systems 4 p 94 1986 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS PO2 3 ANALYTES PO Dry Sensor PO Dry Sensor B Lac Cassette Clinical Significance The PO value of arterial blood is used to assess how well the body is able to absorb oxygen in the lungs Values below the normal arterial PO arterial hypoxemia are usually caused by pulmonary circulatory or respiratory abnormalities e g bronchial obstruction vascular problems decrease in cardiac output increased oxygen dem
95. 9789 0 013 7 17 7 52 103 Analyzer B whole blood 1 0800 0 579 0 9954 0 009 7 01 7 55 173 1 126 0 018 0 946 x 0 134 0 9868 0 018 7 09 7 58 105 1 003 0 008 0 032 0 058 0 9947 0 014 6 86 7 63 174 1 104 0 010 0 739 x 0 077 0 9919 0 014 6 81 7 62 183 whole blood whole blood Analyzer C Analyzer D Analyzer E whole blood For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Peterson JI et al 4 Fiber Optic pH Probe for Physiological Use Anal Chem 53 p 864 1980 3 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and Actuators 9 p 85 1986 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS pH 3 ANALYTES pH Dry Sensor pH Dry Sensor B Lac Cassette Clinical Significance The pH value of the blood serum or plasma may be the single most valuable factor in the evaluation of the acid base status of a patient The pH value is an indicator of the balance between the buffer blood renal kidney and respiratory lung systems and one of the most tightly controlled parameters in the body The causes of abnormal blood pH
96. 993 0 47 0 3 17 5 107 Linearity was also established versus the I STAT analyzer using whole blood samples that had been spiked with lactic acid to cover the measurement range Correlation Slope Intercept Coefficient R Sy x Range n 1 00 0 00 0 978 0 67 1 06 16 91 405 Correlation to Other Methods OPTI CCA TS vs other Lactate Instruments on whole blood in a typical setting Lactate analysis of heparinized whole blood samples was performed at multiple clinical sites Samples were analyzed on the OPTI CCA TS in parallel with laboratory instrumentation operated by hospital personnel and controlled following the hospitals established procedures Correlation Comparative Method Slope Intercept Coefficient R Sy x Range n Analyzer A 0 96 0 01 0 944 0 64 0 78 13 96 175 Analyzer B 1 18 0 54 0 953 0 55 0 40 11 3 49 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz 2006 Clinical Chemistry and Molecular Diagnostics 4th Edition ed C A Burtis E R Ashwood amp D E Burns Eds St Louis Missouri Elseview Saunders 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Lac 4 Operator s Manual OPTI CCA TS ANALYTES tHb SO Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO Clinical Significance total Hemoglobin concen
97. Accession ee vm E Cc Temperature v Sex F DOB r tHb Type F cance Defaults pl Save Bilevel Pressure cancel Defaults H Save Q Up q Home Fig 3 15 Patient Info 2 Operator s Manual OPTI CCA TS In this function you can define which patient information is requested during as well as printed after each measurement 1 From the lt Ready gt display select System Manager and Setup In the System Setup menu press Patient Entry Fig 3 13 In the Info 1 gt screen select the options to be enabled Fig 3 14 Select Optional or Required for Patient ID Operator ID Accession Number Other options to be selected are Temperature Sex DOB tHb Type Press the Info 2 tab to access and enable the following parameters Fig 3 15 Puncture Site Liter Flow Bypass TVOL VT Sample Type PS O Mode PEEP I E Ratio Rate f Vent Mode CPAP Pplat User defined field MVOL VE Bilevel Pressure PIP 3 7 3 CUSTOMIZATION ISystem gt Setup gt Patient Information 10 40 Info Info2 tHb 2 15 0 Edit FIO2 F 0 21 Edt MCHC v 33 3 Za RO iv 0 84 Edt P50 Ei 26 7 ZEat cancel Defaults j Save Fig 3 16 Defaults 3 8 The lt Defaults gt screen Fig 3 16 allows you to program the default values for patient input parameters with the exception of patient temperature The instrument comes with factory programmed default val
98. Blood Gas Systems OPTI CCA TS Analyzer Operator s Manual ye OPTIMedica OPERATOR S MANUAL REVISION LOG Please record any changes made to this manual Revision Release Date Approved by Description A Sept 2004 Released per CO 040316 B Oct 2004 Per CO 040329 C July 2005 Per CO 050197 D April 2006 Per CO 060151 E June 2007 Per CO 070249 F Sept 2007 Per CO 070338 G Dec 2010 Per PCR 100339 H Jan 2011 Per PCR 110016 Information in this document is subject to change without notice Companies names and data used in examples are fictitious unless otherwise noted No part of this document may be reproduced or transmitted in any form or by any means electronic mechanical or otherwise for any purpose without the express written permission of OPTI Medical Systems Inc OPTI Medical Systems Inc may have patents or pending patent applications trademarks copyrights or other intellectual or industrial property rights covering this document or subject matter in this document The furnishing of this document does not give a license to these property rights except as expressly Proprietary Rights Notice provided in any written license agreement from OPTI Medical Systems 2011 OPTI Medical Systems Inc All rights reserved OPTI the OPTI Medical logo and ComfortSampler are trademarks or registered trademarks of OPTI Medical Systems Inc in the United S
99. Carefully open the ampoule by breaking off the top es NOTE Protect your fingers by using gloves or tissue while breaking ampoule Fig 4 22 Place Control Operator s Manual OPTI CCA TS 4 11 4 CALIBRATION AND QUALITY CONTROL Fig 4 23 Direct Aspiration La E AU gt Fig 4 24 Attach Capillary Tube Measuring 10 40 12 Nov Gas 83 Baro 732 4 Control Measurement In Progress Please Wait Measuring Fig 4 25 QC Measurement 4 12 e Either aspirate directly from the ampoule or use a capillary to withdraw a small amount of control material from the ampoule for aspiration 13 Hold the ampoule at a 45 angle during aspiration Fig 4 23 Use a new ampoule for each sample 14 If using capillary tubes push the tube firmly into the fillport see Fig 4 24 15 Press 9X The QC sample is aspirated into the cassette and the measurement starts Fig 4 25 At this time the status light begins flashing green indicating that the cover should not be opened Operator s Manual OPTI CCA TS DC Control Results Limits 7 417 7 431 39 1 41 1 PASS 88 6 92 6 PASS 6 00 6 10 FAIL 13 1 13 5 FAIL 148 5 150 5 PASS 5 01 4 93 5 07 PASS 1 21 Ou Fig 4 26 QC Results Measuring 10 40 12 Nov Gas 83 1 17 1 25 PASS Loi Home Baro 7324 Control Results Pass Reject Review Fig 4 27 Accept QC Results QC
100. Control Open Measurement Chamber Cover and Remove Cassette Fig 4 28 Open SMC Cover and Remove Cassette Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL Upon completion of the measurement the results are displayed Fig 4 26 e The OPTI CCA TS Analyzer will indicate whether the values are within or outside the programmed ranges with a lt Pass Fail gt display next to the parameter label e Results obtained are applicable to the sensor cassette type being used for patient sample E Ca Type shown for reference 16 Press E H lo accept or reject results e Press lt Accept gt if results are acceptable Fig 4 27 and the results will be stored in the Control Database e Select lt Reject gt to reject the results Rejected results will not be stored in the Control Database e Select lt Review gt to view the results again In either case the results will be printed when the data input is complete Please follow the regulatory guidelines of your hospital for documenting corrective action if results are rejected If any of the results are outside of the OPTI CCA TS s measurement range giving a LOW or HIGH the results cannot be accepted to the controls database 17 Open the sample chamber cover and remove the cassette Fig 4 28 e If other levels of controls are to be run repeat the procedure 4 13 4 CALIBRATION AND QUALITY CONTROL 4 5 4 Printing Control Repo
101. ENANCE Once a year the peristaltic pump cartridge and gas I O port must be replaced to assure that your analyzer operates at peak performance 6 4 1 Replacing Peri Pump Cartridge To change the cartridge Fig 6 16 Remove Pump Cartridge gt Fig 6 17 Pump Seals MEE Fig 6 18 Install New Cartridge Operator s Manual OPTI CCA TS d Open the printer cover door The peri pump is located to the right of the printer Remove the pump by firmly grasping the ends of the housing and pulling upward Fig 6 16 Replace the pump seals only as needed Remove the old pump seals with a pair of hemostats or tweezers Fig 6 17 Carefully grasp the seal and pull it out CAUTION When removing the seals take extra care to avoid damaging the nipples located at the bottom of the seal recess Press the new pump seals into the seal recess with the large side facing up Install the new pump cartridge by first rotating the flat surface on the pump motor shaft to align with the flat surface of hole keyway in the pump cartridge roller Press the cartridge firmly down until it is fully seated on the housing of the instrument Fig 6 18 6 MAINTENANCE Fig 6 19 Push on Pump Roller 6 4 2 Replacing Gas I O Port Fig 6 20 Gas I O Port 6 8 Press the pump cartridge roller down until it firmly seats on the shaft of the pump motor Fig 6 19 Perform a Pump Test see section 7 2 16 to ensure corr
102. ENEE D 7 Maintenance Report vissuisccsssossssstdsvesssviessntsassasvessaressnensseanasseamsadancaaasienswansnanyetsadeadaauadagwenneamened D 8 EIER EE EE D 9 Lactate Setup WEE en EE D 10 UND EX emc n Li VI Operator s Manual OPTI CCA TS 1 1 1 1 2 1 3 1 4 1 5 1 INTRODUCTION OK ei enn e DE 1 1 Intended US C 1 1 Principles of Operation ura a certc sue sE a asp aA xU eerste eee ee 1 1 lg me 1 2 Analyzer ComponentsS de 1 3 Consumables m 1 7 Operator s Manual OPTI CCA TS 1 i 1 1 1 2 1 INTRODUCTION INTRODUCTION Intended Use The OPTI CCA TS Critical Care Analyzer is intended to be used for the measurement of hydrogen ion concentration pH carbon dioxide partial pressure PCO oxygen partial pressure PO sodium Na potassium K ionized calcium Ca chloride CI glucose Glu blood urea nitrogen BUN urea lactate Lac total hemoglobin concentration tHb and hemoglobin oxygen saturation SO in samples of whole blood and pH sodium potassium ionized calcium chloride glucose and BUN urea in serum and plasma in either a traditional blood gas clinical laboratory setting or point of care locations by personnel minimally qualified to perform and report these results The table bel
103. Instrument adjustment and maintenance with removed covers and connected power mains are to be performed only by a qualified technician who is aware of the dangers involved Instrument repairs are to be performed only by the manufacturer or qualified service personnel Important Information Important Information Operating Safety Information e Overvoltage Category Ill when connected to a branch circuit e This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules Caution The instrument is designed as a conventional device closed not waterproof type Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide This instrument is suitable for continuous operation The power plug is to be plugged into a ground socket only When using an extension cord make sure that it is of the proper size and is properly grounded Any breakage of the ground lead inside or outside the instrument or a loose ground connection can cause a hazardous condition when operating the instrument Intentional disconnection of the grounding is not permitted When replacing the fuses make sure that they are of the same type and rating as the original fuses Never use repaired fuses or short circuit the fuse holders This device is a Class 1 Laser product according to the requirements of IEC
104. K MEME Fig 6 5 Enter Lot Number Not Ready 10 40 12 Nov Open Cover Cancel Fig 6 6 Open Cover Clean Optics and Inside of Cover x Fig 6 7 Clean Optics and Inside of Cover Operator s Manual OPTI CCA TS 6 MAINTENANCE 6 Enter the lot number of the tHb Calibrator cassette located on the top surface of the cassette and press ok Fig 6 5 7 At the prompt open the SMC cover by pressing the button Fig 6 6 8 Gently clean the optics window and the inside top cover of the sample chamber with a soft lint free cloth Fig 6 7 Press ox 6 3 6 MAINTENANCE Not Ready 10 40 12 Nov Open Pouch and Wipe Cassette 9 Gently wipe both sides of the tHb Calibrator Om Cassette with a clean dry cloth and examine it to e ensure it is clean Insert it into the chamber and press down to properly seat the cassette Fig 6 8 Insert Cassette Cancel Fig 6 8 Wipe and Insert Cassette Not Ready 10 40 12 Nov Close Cover 10 Close the sample chamber cover Fig 6 9 Fig 6 9 Close Cover Y e After the cover has been closed the instrument will automatically detect the presence of the calibrator cassette and begin calibration Fig 6 10 11 After the calibration is complete you will be tHb Calibration In Progress Please Wait e prompted to open the sample chamber cover and remove the cassette Calibrating uu a mec 12 Place the calibrator cassette back into
105. Kit BP0610 ComfortSampler Bulk w Needle BP0620 ComfortSampler Bulk w o Needle BP0630 ComfortSampler Bulk Needle w Protector BP0640 9 5 Accessories Battery Charger BP7036 Battery Assembly BP7007 CF Export Kit BP7140 Case Carrying YB7025 9 6 Manuals Operator s Manual PD7040 CD Operator s Manual PD7066 Service Manual PD7041 9 2 Operator s Manual OPTI CCA TS 9 SUPPLIES Description Part Number 9 7 Spare Parts Peripump Cartridge Kit BP7012 Power Supply EI7007 Power Cord EX0197 Power Cord Schuko EX0173 Printer Assembly BP7090 Seal SMC Gas I O Port RE7030 9 8 Technical Assistance Most often problems with your OPTI CCA TS can be resolved over the telephone getting the analyzer back in service within minutes Our technicians have the training and experience necessary to provide dependable technical assistance The OPTI Medical Service Hotline U S market only is staffed to provide prompt troubleshooting assistance seven 7 days per week twenty four 24 hours per day Should you need troubleshooting assistance or application information regarding your OPTI Medical analyzer just contact the OPTI Medical Service Hotline for assistance In the U S call 1 800 490 6784 OPTI to request technical assistance from OPTI Medical Systems Inc Should you require additional service support our OPTI Medical Service Hotline can provide complete details on all available service options and ensure that any
106. NEN D 5 lee Ee Report Pant eee D 6 Contguration Report PAT 2 tac D 7 Maintenance Report D 8 ygelgiat ieol e EE ESA D 9 Lactate Setup Report D 10 Operator s Manual OPTI CCA TS A i APPENDIX A TECHNICAL SPECIFICATIONS APPENDIX A TECHNICAL SPECIFICATIONS Measurement Range Parameter Range Display Units Resolution Lo Hi pH 6 6 to 7 8 0 01 0 001 pH units PCO 10 to 200 1 0 1 mmHg PO 10 to 700 1 0 1 mmHg Na 100 to 180 1 0 1 mmol L K 0 8 to 10 0 1 0 01 mmol L Ca 0 2 to 3 0 0 01 mmol L CI 50 to 160 1 0 1 mmol L Glu 30 to 400 0 1 mg dL 70 to 400 for samples with PO levels between 401 700 mmHg Glu 1 7 to 22 0 01 mmol L BUN 2 8 to 112 0 1 mg dL Urea 1 to 40 0 01 mmol L Lac 0 3 to 17 5 0 01 mmol L tHb 5 to 25 0 1 g dL SO 60 to 100 1 0 1 Barometric Pressure 300 to 800 mmHg Operating Altitude Up to 3048m 10 000ft Pollution Degree Degree 2 normal indoor laboratory environment Air contains only non conductive pollutants with occasional condensation Operator s Manual OPTI CCA TS A 1 APPENDIX A TECHNICAL SPECIFICATIONS Operating Parameters Minimum Sample Size Sample Type Sample Application Sample Input Analysis Time Ambient Temperature Range Relative Humidity Range Type of Measurement Input Values A 2 Patient ID Operator ID Accession Number Patient Temperature Patient Sex Date of birth Hemoglobin Type Puncture Site Bypass Sample T
107. NTENANCE E 6 1 61 Daily Maintenance P 6 1 ABI Aa E e 6 1 6 3 Quarterly Maintenance Performing tHb Calibration 6 1 6 9 Performing HbCal tHb EE 6 1 6 3 2 Performing HbCal Last BIDOU andi eege s hd dmt se Sana 6 6 64 Annual EE 6 7 6 4 1 Replacing Peri Pump Cartridge T p 6 7 6 4 2 Replacing Gas e EE 6 8 65 As Needed Mainten nte saci aaa cada ted iienaa innean ndedicedniedennicete EA 6 9 BT Changing the Gas Bolle spese a ER RE RARE eieeduusnapusntneiereteauadaeondensiamestunxmcdateatmates 6 9 6 54 Changing the Printer Papel uccisi eiui cans Goes EU eod res Rc EPFL deed 6 11 6 5 3 Performing Routine Cle AiG EE 6 12 7 DIAGNOSTICS AND TROUBLESHOOTING 7 1 1 1 Error Displays 7 1 1 2 Cono 2a anaran enaena a eee 7 12 7 2 1 Checking VersSiONS T 7 12 7 2 2 Checking System Temperatures 2 dosteet eege gedd egeebet 7 13 7 2 9 Checking Gas Pres Sie aicut dud Ead dtoe aeda tus et iad ai ea adea a AA c pn 7 13 L24 Checkngthe e RT RTT 7 14 7 2 5 Verifying Barometric PressUrg sssiscscnisnrsenatoossaxsadoraestexvanssaacbaseadamuniansacsstenwecvaandaumansiee 7 14 4 2 6 Checking the Battery EIERE eet 7 15 poca Checking the Cooling FaN EE ME 7 15 7 2 8 Checking the Gas Valve PREX 7 16 7 2 9 Checking the Valve Div Giscssccctsccasscscssunnakinctcniantssedenanceean
108. Na 1 Spare parts 9 3 Specimen collection and handling 5 1 8 3 SRC Measurement running 4 4 SRC Results printing 4 7 Standard pH 8 9 calculation A 8 reference ranges A 5 Standard Reference Cassette SRC setting up 3 3 Status light description 1 4 Supplies 9 1 Symbol definitions VII Syringe adapter description 1 7 8 14 INDEX Syringes 5 2 8 3 T Technical assistance 9 3 Technical specifications A 1 Temperature corrected values A 4 Temperatures system checking 7 13 Test conditions 5 4 8 6 tHb Calibration Cassette 1 8 Thermal printer See Printer Time and date setting 2 3 3 1 Total CO2 8 9 calculation A 9 reference ranges A 5 Total hemoglobin concentration ctHb clinical significance THB SO2 1 Correlation to Other Methods THB SO2 4 Interferences THB SO2 2 Linearity THB SO2 3 measurement principle THB SO2 2 measurement range THB SO2 2 reference intervals THB SO2 2 References THB SO2 4 Reproducibility THB SO2 3 SRC Limit Values THB SO2 2 Touch screen description 1 4 test 7 23 Troubleshooting 7 1 bar code scanner 7 34 procedure for tHb SO2 7 33 U Units of measure conversion A 8 used for calculations A 8 V Valve drive checking 7 16 Versions checking 7 12 W Warranty registration 9 4 Whole blood samples 5 4 Operator s Manual OPTI CCA TS
109. O 10 37 mmHg PO value corrected to patient temperature other than 37 C 5 49107 11 p053 88 0 071 i 9 7210 9 PO3 8842 30 t 37 PO PO 10 mmHg Operator s Manual OPTI CCA TS APPENDIX A TECHNICAL SPECIFICATIONS AaDO Alveolar to arterial oxygen tension difference corrected to patient temperature other than 37 C AaDO PAO Pap mmie where PAO P ue PE O FIO PACO FIO 1 FIO R with PH Or 47 1 0 0237 0 0001 t 37 t 37 and PACO PaCO alveolar PCO arterial PCO Apply above equation for PAO PO otherwise PAO PO total Hct c Hct c as a function of tHb Hct c tHb g dl MCHC 100 d H Where MCHC is the Mean Cell Hemoglobin Concentration representing the average concentration by weight of hemoglobin inside the average red cell Default value of MCHC 33 3 input range 29 0 to 37 0 AG The anion gap is a calculated parameter used to express the difference in concentrations of major cations and anions in the blood specimen AG Nat K Cl HCO3 mmol L nCa The ionized calcium value normalized to pH 7 40 For blood nCa pH 7 4 Ca 10 929924 mmol L For plasma or serum na pH 7 4 Ca 10 924 pH 74 mmol L 10 Simmons A ed Hematology A Combined Theoretical amp Technical Approach pp 28 29 Philadelphia W B Saunders 1989 Operator s Manual OPTI CCA TS A 13 AP
110. O arterial hypoxemia are usually caused by pulmonary circulatory or respiratory abnormalities e g bronchial obstruction vascular problems decrease in cardiac output increased oxygen demand anatomical heart defect low inspired O content Generally O levels above 100 mmHg do not contribute significantly to the oxygen content since with normal hemoglobin concentrations 80 100 mmHg PO provides a 97 saturation level and a level greater than 100 cannot be achieved Measurement Principle The PO optode measurement principle is based upon luminescence quenching first documented in the 1930 s and commercially utilized to measure blood PO in 19833 The relationship of luminescence to PO is quantified by the Stern Volmer equation I 1 1 kP which describes how the fluorescence emission intensity T is reduced as the PO P is increased Unlike conventional electrochemical Clark PO electrodes the oxygen optode does not consume oxygen molecules during the measurement The PO partial pressure is influenced by the local barometric pressure as dictated by Dalton s law The OPTI CCA TS incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS has been factory calibrated to the absolute barometric pressure Measurement Range Range Resolution Low High Units 10 to 700 1 0 1 mmHg Standard Reference Cassette SRC Limit Values
111. OPTI CCA TS PCO2 B 1 PCO Dry Sensor Interferences ANALYTES Tonometered whole blood samples were spiked with a number of endogenous and exogenous chemicals and tested for interference following the CLSI guideline EP7 A2 Chemical Interferent PCO Level Interference Concentration 83 mmHg NO Acetaminophen 1 66 mM 17 mmHg NO m 83 mmHg NO Acetylsalicylic acid 3 33 mM 17 mmHg NO n 83 mmHg NO Ascorbic acid 0 23 mM 17 mmHg NO f 83 mmHg NO B Hydroxybutyric acid 16 03 mM 17 mmHg NO 83 mmHg NO Bilirubin 0 26 mM 17 mmHg NO i 83 mmHg NO Cardiogreen 0 0065 mM 17 mmHg NO 83 mmHg NO Cystein 6 41 mM 17 mmHg NO 83 mmHg NO Ethanol 86 8 mM 17 mmHg NO 83 mmHg 24 68 mmHg Evans blue 0 0104 mM 17 mmHg NO 83 mmHg NO Glycolic acid 10 mM 17 mmHg NO 83 mmHg NO Halothane 0 759 mM 17 mmHg NO 83 mmHg NO Ibuprofen 2 43 mM 17 mmHg NO P 83 mmHg NO Intralipid 196 17 mmHg NO 83 mmHg NO Methylene Blue 0 125 mM 17 mmHg NO 83 mmHg NO Sodium Chloride 20 mM 17 mmHg NO PCO2 B 2 Operator s Manual OPTI CCA TS ANALYTES PCO Dry Sensor Reproducibility Controls Within Run Swr and Total ST Precision were determined from 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for three different lots of B Lac cassettes are shown below
112. Oxygen Saturation SO When each heme group of the hemoglobin molecule is associated with one molecule of oxygen the hemoglobin is referred to as oxyhemoglobin O Hb The amount of oxyhemoglobin expressed as a fraction of the total functional hemoglobin able to bind oxygen is termed hemoglobin oxygen saturation SO The largest portion about 98 of blood oxygen content is the oxygen bound to hemoglobin The reference interval for arterial blood from healthy adults is typically 94 to 98 2 Decrease in SO below the critical level necessary for tissue oxygen saturation is a grave clinical situation Low oxygen saturation may be caused by many of the same factors responsible for arterial hypoxemia Low fractional oxyhemoglobin FO Hb defined as a fraction of total available hemoglobin may also be caused by unusually large amounts of non functional hemoglobins high concentrations of deoxyhemoglobin chemically altered hemoglobin or factors affecting the affinity of hemoglobin for oxygen including temperature pH PCO 2 3 DPG concentration and type of hemoglobin Operator s Manual OPTI CCA TS THB SO2 1 tHb SO ANALYTES Measurement Principle The measurement of total Hemoglobin ctHb and oxygen saturation SO uses the well established principle of optical reflectance Red and infrared light at three wavelengths is directed at whole non hemolyzed blood within a precisely defined part of the cassette over the O optode The phot
113. PENDIX B MENU STRUCTURE APPENDIX B MENU STRUCTURE JOUR dnas opge seg a SHUN yono I9 159 uono Uonejao Aedsiq SIT uuelv dung sabuey jeuuoN MO J snooue aosi eBenDue Weed 9 e2 e pear S4 Sqa31 eoueusjurey UleJeqd Spo SJOJI3 S9100 BAU ONLA 9497 seo J Uld qu3 jueneg S ONUOD S O NUOD Jeyuud ane Spe eunjeleduie eJeMpieH 01u02 eoueuojurey OMS OMS epoojeg ue SUOISI9A unoesg RE uogeun8yuo qualjed jueneg x Y Y 5 rY D A t S se 101 u09 SJOSU8S snoopie Ouse SEN spod y uoneiqie SE l de DIE snoauel aosi ub jueuieJnseejv J A A A A A A A t eoueuajure A souen Aug Wand Br dE sonsouDeig ejeq pue aui qH RER t 7 juswaunseay A JeDeue y waysks A JeBeuew 20 A JaBeueyy ejeg A nua Apeay B 1 Operator s Manual OPTI CCA TS APPENDIX C MAINTENANCE LOG APPENDIX C MAINTENANCE LOG Month Year WEEKLY Week 1 Week 2 Week 3 Week 4 Date Initial Date Initial Date Initial Date Initial Clean Sample Measurement Chamber QUARTERLY Date Initial Date Initial Date Initial Date Initial Perform tHb Calibration ANNUALLY
114. PPENDIX A TECHNICAL SPECIFICATIONS RmAir Mask T P NC Vent Bag Hood Other Where RmAir Room Air Mask Mask T P T Piece NC Nasal Cannula Vent Ventilator Bag Bag manual resuscitation Hood Hood Other Other 0 21 1 0 0 70 2 00 15 40 No SIMV PSV PCV CMV AC CPAP PCIVR BIPAP PRVC where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure PRVC Pressure Regulated Volume Control 0 4000 0 120 0 140 0 100 0 99 9 0 50 0 50 0 155 000 00 300 00 0 2 9 9 0 2 9 9 0 2 9 9 0 2 9 9 9 alphanumeric characters A 3 APPENDIX A TECHNICAL SPECIFICATIONS Calculated Values Actual bicarbonate HCO Base excess BE Base excess ecf BE Base excess actual BE Buffer bases BB Total CO tCO Standard bicarbonate st HCO Standard pH st pH Oxygen saturation SO Oxygen content O ct Hematocrit Hct c Hydrogen ion concentration cH Alveolar arterial oxygen partial pressure difference AaDO Anion Gap AG P50 nCa Temperature Corrected Values A 4 1 0 200 0 mmol L 40 4 40 4 40 4 40 mmol L 40 mmol L 40 mmol L 0 0 100 0
115. PTI cassettes is calibrated during the manufacturing process The process utilizes high precision standard solutions spanning the operating range for pH and ions For O CO tHb and SO the calibration parameters are determined using specially targeted calibration standards focusing on the clinically critical ranges Every cassette package has a bar code label containing this calibration information as well as its lot number and expiration date Prior to running a sample the cassette s bar code is scanned into the analyzer by holding the cassette package in front of a conveniently located bar code scanner The cassette is then installed and a calibration is performed using the precision buffer within the cassette and a precision gas mixture similar to that used by conventional blood analyzers In addition an optical zero point calibration of all six channels is performed During the calibration and measurement processes diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette These tests include automatic checks of the cassette for packaging integrity proper cassette temperature control fluidic control during calibration proper equilibration behavior of the sensors during calibration and measurement automatic detection of bubbles and short sample during aspiration and automatic detection of low gas or low battery dirty optics or worn pump conditions Operator s Manual OP
116. QNex again and select the following Bilevel Pressure Fig 5 19 TT tdt e BiLevel Pressure default value 0 00 0 00 Eat e T E Ratio default value 0 VE Ratio Back Page 6 of 7 Next Q Finish Fy Home am Fig 5 19 Edit patient data 6 Measurement Patient Data 16 The last set of patient data contains the nisal 1040 A Haney following information Fig 5 20 User Field 1 Jooooooooo SC EIC e User Field 1 9 alphanumeric characters User Field 2 QooooQQQOQ Edt User Field 3 faqaaaaaca Ara e User Field 2 9 alphanumeric characters Blanking e User Field 3 9 alphanumeric characters pH r CL r PCO2 r Ca r B lanking Ze 2 REN NOTE Parameter blanking will omit a parameter un ei b K r ps E from the printout See Section 3 3 2 2 for tHbiso2 r detailed description gBack Page 7 of7 Next Qro E nen em 17 If no value is entered a default value will be used and printed Fig 5 20 Edit patient data 7 Operator s Manual OPTI CCA TS 5 11 5 SAMPLE HANDLING AND PATIENT TESTING iMeasurement gt Results C wn TY Iculated Calibration pH 7 188 PCO2 70 6 mmHg PO2 70 5 mmHg tHb 841 gd SO2 20 Na 126 0 mmol L K 3 01 mmol L Cat 1 55 mmol L 6 Up Home Fig 5 21 Measurement results iMeasurement gt Results 3 8 mmol L 28 4 mmol L 26 2 mmol L 44 2 mmol L 4 5 mmol L 2 0 mmol L 20 7 mmol L gBack Page 1 of2
117. RF Right Femoral Scalp Scalp 13 Press QNex for the following information Fig 5 17 Vent Mode No SIMV PSV PCV CMV AC CPAP PCIVR BIPAP PRVC where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Supported Ventilation PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure PRVC Pressure Regulated Volume Control O2 Mode Rm Air Mask T P NC Vent Bag Hood Other where RmaAir Room Air Mask Mask T P T Piece NC Nasal Canula Vent Vent Bag Bag Manual Resuscitation Hood Hood Other Other Bypass Off pump or on pump Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING Measurement gt Patient Data 14 The next set of patient data contains the ramis iul LL following information Fig 5 18 PEEP Heat hd Casel e PEEP default value 0 Rate 0 geet e CPAP default value 0 WE e Rate f default value 0 bpm saa a e Liter Flow default value 000 00 Lpm SIS EH e TVol VT default value 0 mL Pplat seat e MVol VE default value 0 L T e e PIP default value 0 Q9 Pagesot7 Gei e Pplat default value 0 rs aree Im e PS default value 0 Fig 5 18 Edit patient data 5 leasurement gt Patient Data Measuring 1040 12 Nov 15 Press
118. System Setup menu press the Miscellaneous tab and then Hardware In the Settings screen select Beep Enable Fig 3 37 Select High or Low for lt Beep Volume Press lS to accept the changes Press E lto return to the lt Setup gt screen or Home to return to lt Ready gt 3 21 3 CUSTOMIZATION 3 3 3 4 Battery Saver iSystem gt Setup gt Hardware Not Ready 1040 12 Nov Settings Interface Ethernet Omer Teoma ge Beep Enable r Beep Volume High Low Cc r Backlight Autooff Enable cance Defaults H Save Q Up O Home Fig 3 38 Backlight Auto Off 3 22 This menu allows you to set options that will help conserve power to extend battery life The battery saver options are only active if the analyzer is operated from the battery 1 From the lt Ready gt display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press the Miscellaneous tab and then Hardware 3 Inthe Hardware screen select the following options Fig 3 38 e Backlight AutoOff Enable gt If battery save mode is also enabled the backlight of the display will turn off automatically after the selected duration NOTE The screen will appear dark when the analyzer is in standby mode and Backlight Auto Off is enabled Press the touch screen to exit standby mode and resume normal operation e Battery Save Mode will put the instrument i
119. TI CCA TS 8 9 8 OPERATING PRINCIPLES 8 5 6 Quality Control On initial use of each shipment of cassettes and at 1 month intervals thereafter validation of the lot should be performed by analysis of OPTI Medical blood gas electrolyte metabolite tHb and SO controls OPTI CHECK or OPTI CHECK PLUS or other equivalent material which has been recommended by OPTI Medical Systems This material should provide target values for all measured parameters over a range of measurement values typically seen in each laboratory The results obtained should fall within limits defined by the day to day variability as measured in the user s laboratory It is recommended to aspirate Quality Control and Proficiency testing material directly from the ampoule This procedure helps to minimize sensitivity to pre analytic and other errors associated with the use of aqueous controls see Limitations Section A minimum of two Standard Reference Cassettes SRCs of different levels should be used as a control for measurement and proper analyzer operation OPTI Medical Systems recommends that the SRC measurement be confirmed within acceptance ranges on both levels once each day of OPTI CCA TS operation These special test cassettes contain a stable optical sensor simulator which is measured by the device in exactly the same manner as any other cassette and provides assurance that measurement of all analytes by the device is consistent The results obtained should
120. a occurs within 5 hours of a carbohydrate meal in otherwise normal patients in patients with early adult onset diabetes mellitus and in patients who have had gastric surgery Fasting Hypoglycaemia can be due to insulinomas non pancreatic tumors endocrine disorders liver failure sepsis renal failure or autoimmune disorders Operator s Manual OPTI CCA TS Glu 1 GLUCOSE ANALYTES Measurement Principle The glucose optode measurement is based on the enzymatic oxidation of glucose Glucose O gluconic acid H O glucose oxidase The sensor is constructed of an enzyme layer over an oxygen sensor As a sample containing glucose contacts the sensor the oxidation of the glucose consumes the oxygen locally present in the sensor This decrease in oxygen is detected in the same manner luminescence quenching as described for the PO optode The amount of glucose is determined to be proportional to the rate at which the oxygen is consumed Measurement Range Range Resolution Low High Units 30 to 400 0 1 mg dL 70 to 400 mg dL for samples with PO levels between 401 700 mmHg 1 7 to 22 0 01 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 40 0 4 110 0 4 300 0 4 mg dL 2 2 0 22 6 1 0 22 16 65 0 22 mmol L Interferences The OPTI CCA TS Glu sensor does exhibit an interference from oxalate and EDTA at the levels used for anticoagulants Heparin salts are therefore the only accepta
121. ach level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Chloride linearity is established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions Chloride Chloride linearity in serum is established against Chloridometry Chloride Correlation Slope Intercept Coefficient Sy x Range n Chloride 1 0076 0 56 0 99984 0 68 58 160 15 Chloride 1 0064 244 0 99823 1 66 74 142 16 CI 2 Operator s Manual OPTI CCA TS ANALYTES CHLORIDE Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9965 0 95 0 9246 1 96 92 117 173 For more information on specific analyzers used please contact OPTI Medical Technical Support Reference
122. ads lot expiration information and QC ranges if applicable from cassettes controls SRCs and gas bottles as well as user input bar codes for operator and patient IDs Fig 1 5 j C Fig 1 5 Bar Code Scanner Thermal Printer The thermal printer is accessed by raising the door on the top of the unit Fig 1 6 The printer uses heat sensitive paper to output information in 27 columns The analyzer can print measured values quality control values calibration values as well as patient and diagnostic information Fig 1 6 Thermal Printer Peristaltic Pump Contained within the same compartment is a peristaltic pump cartridge which is used to transport liquids and gases Fig 1 7 All liquids are contained within the OPTI Cassette and do not enter the instrument NOTE The peristaltic pump cartridge is a replaceable item See Maintenance Section 6 4 1 Fig 1 7 Peristaltic Pump Operator s Manual OPTI CCA TS 1 5 1 INTRODUCTION 1 6 Model and Serial Numbers The model and serial number identifiers are located on an identification plate on the bottom panel of the unit Fig 1 8 Fig 1 8 Model and Serial Numbers Back of Analyzer On the rear of the unit is Fig 1 9 CF Slot e An RS232 interface port e An Ethernet port e An LED which indicates the charging status of the battery e A storage compartment that can hold an extra paper roll the SRCs other supplies or Storage RS23
123. after equilibrating with the blood sample After a single measurement the cassette containing the blood sample is removed from the analyzer and discarded The analyzer contains no reagents blood or waste During each measurement light originating from lamps in the analyzer is passed through optical filters so that photons of a specific color are transmitted to the sensors causing them to emit fluorescence The intensity of this emitted light depends upon the partial pressure of oxygen PO carbon dioxide PCO hydrogen ion concentration pH electrolyte concentration Na K Ca CI or metabolite concentration glucose BUN urea lactate of the blood in direct contact with the sensors as described above The light emitted by the fluorescent sensors 1s measured by the analyzer after passing through lenses and additional optical components A filter is used to isolate specific colors of interest from this returning light for measurement by a light detector For tHb and SO red and infrared light from one LED and two laser diodes is directed via dichroic beamsplitters and optical waveguides onto and through an optically polished window to the blood in the cassette over the O sensor This light is partially absorbed and reflected by the erythrocytes and sensor overcoat then reflected back up into the instrument traveling via an optical waveguide to a photodiode The intensity of light reflected back at each wavelength varies in a well
124. against reference materials or methods The linearity of the dry pH sensor has been established versus the standard pH sensor which is already approved for use on the OPTI CCA TS system Whole blood samples tonometered with different CO gas mixtures were used to establish the correlation Linearity of Whole Blood Samples Correlation Slope Intercept Coefficient Sy x Range n 0 99 0 09 0 996 0 016 6 59 7 86 189 Operator s Manual OPTI CCA TS pH B 3 pH Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS vs other pH Instruments on whole blood in a typical setting pH analysis of heparinized whole blood samples was performed at multiple clinical sites Samples were analyzed on the OPTI CCA TS in parallel with laboratory instrumentation operated by hospital personnel and controlled following the hospital s established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n OPTIR 0 96 0 27 0 984 0 019 6 78 7 54 147 Analyzer A 1 03 0 20 0 968 0 015 7 091 7 538 111 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other pH Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO gas mixtures to generate a wide range of pH values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Corr
125. aily basis This should be based on hospital policy The system default is QC lockout disabled 1 Select the desired option 2 Press Hse to accept the changes 3 Press C un lio return to the Setup screen or f Home to return to Ready Operator s Manual OPTI CCA TS 3 3 3 1 3 Setting up Secure Operator IDs ISystem Setup Security Not Ready 10 40 Password QC Lockout Coro Secure Operator ID Enable Operator ID PIN Add 00000000000 0000 00000000000 0000 X Delete 00000000000 0000 00000000000 0000 KON 00000000000 0000 Print 00000000000 0000 00000000000 0000 5 Up 00000000000 0000 00000000000 0000 Q Up Zonen Fig 3 34 Select OP IDs 7 Doum Operator s Manual OPTI CCA TS 3 CUSTOMIZATION The OP IDs menu is used to enter Operator identification IDs and password PIN With this feature enabled the system will lock out unauthorized users from operating the analyzer e Select OP IDs in the Security menu Fig 3 34 e Select Secure Operator ID Enable NOTE If you do not select this option the Secure Op IDs feature is turned off and operators will not be required to enter their PIN numbers to operate the analyzer 1 Press to enter the Operator ID number up to 11 digits and a unique 4 digit personal identification number PIN to be added to the list of authorized users The analyzer can store
126. al OPTI CCA TS K 1 POTASSIUM ANALYTES Interferences The OPTI CCA TS K sensor has no measurable interference from Na variation within the range 100 190 mmol L The OPTI CCA TS K results include an appropriate correction for pH at all values of pH This correction may introduce an extra source of variability at the extreme values The OPTI CCA TS K sensor has no interference from ammonia or ammonium ion present at normal physiologic levels below 100 umol L At hyperammonemia plasma levels of 300 umol L the OPTI CCA TS K sensor will show a potassium offset of 0 4 mmol L and at extreme hyperammonemia plasma levels of 3000 umol L the OPTI CCA TS K sensor will show a potassium offset of 4 4 mmol L Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogenous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount K change mmol L Sodium fluorescein 26 mg dL 0 7 Cardio indocyanine green 0 5 mg dL 0 4 Methylene blue 25 mg dL 2 4 Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials
127. alibration Method Perform a tHb Calibration using the tHb Calibrator Cassette per Section 6 3 1 prior to beginning HbCal Last Blood Perform a normal sample analysis using a sample previously measured on an alternate analyzer Ensure the sample is well mixed prior to measurement From the lt Ready gt display select lt QC Manager gt Press lt tHb Calibrator gt Fig 6 13 Select lt Last Blood gt Fig 6 14 Use the numeric keypad to enter the tHb value Fig 6 15 Press ok to save the value NOTE If an HbCal has been performed with the tHb Calibrator the last measured blood tHb and SO will not be available and a new blood measurement must be made to perform an HbCal with blood OPTI Medical Systems recommends use of the tHb Calibrator and not blood for calibration of tHb and SC NOTE A maximum of 3g dL tHb correction and 3 SO correction is allowed due to constraints within the instrument tHb Calibrator NOTE The instrument will not allow a value to be Fig 6 14 Select Last Blood Cancel OK Enter tHb x 7 7 Si alt S 4 5 6 AE E Fig 6 15 Enter tHb Value 6 6 entered that is outside the instruments range for adjustment or measurement Use the numeric keypad to enter the SO value Press ok to save the value Press f none to return to the Ready screen Operator s Manual OPTI CCA TS 6 4 Annual Maintenance 6 MAINT
128. analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 8732 0 064 0 8392 0 07 0 7 1 3 103 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Burritt MF Pierides AM Offord KP Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders Mayo Clinic proc 55 606 1980 3 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS Ca 3 ANALYTES CHLORIDE Chloride CI Clinical Significance Chloride is an anion that exists predomininantly in extracellular spaces It maintains cellular integrity through its influence on osmotic pressure It is also significant in monitoring acid base balance and water balance In metabolic acidosis there is a reciprocal rise in chloride concentration when the bicarbonate concentr
129. and anatomical heart defect low inspired O content Generally O levels above 100 mmHg do not contribute significantly to the oxygen content since with normal hemoglobin concentrations 80 100 mmHg PO provides a 97 saturation level and a level greater than 100 cannot be achieved Measurement Principle The PO optode measurement principle is based upon luminescence quenching first documented in the 1930 s and commercially utilized to measure blood PO in 19833 The relationship of luminescence to PO is quantified by the Stern Volmer equation L I 1 kP which describes how the fluorescence emission intensity I is reduced as the PO P is increased Unlike conventional electrochemical Clark PO electrodes the oxygen optode does not consume oxygen molecules during the measurement The PO partial pressure is influenced by the local barometric pressure as dictated by Dalton s law The OPTI CCA TS incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS has been factory calibrated to the absolute barometric pressure Measurement Range Range Resolution Low High Units 10 to 700 1 0 1 mmHg 1 30 93 31 0 1 0 01 kPa Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 60 0 3 100 0 3 170 0 3 mmHg 8 00 0 40 13 33 0 40 22 66 0 40 kPa Operator s Manual OPTI CCA TS PO2 B 1 PO Dr
130. and prompt you to verify the lot number and SS level Fig 4 6 This information can be found on both the SRC cassette itself and its storage pouch Yes Fig 4 6 Confirm SRC Information If the information shown on the display is correct press Ye to continue If this information is incorrect press No to interrupt this sequence and return to lt QC Manager gt See Section 3 3 1 1 Setting up the Standard Reference Cassette SRC Operator s Manual OPTI CCA TS 4 5 4 CALIBRATION AND QUALITY CONTROL SRC Measurement In Progress Please Wait Measuring Fig 4 7 SRC Measurement IQC gt SRC gt Results Ready 10 40 12 Nov Para Result Limits Pass meter Fail pH 7 42 7 417 7 431 PASS PCO2 40 1 39 1 41 1 PASS PO2 89 7 88 6 92 6 PASS Na 149 3 148 5 150 5 PASS K 5 01 4 93 5 07 PASS Ca 1 21 1 17 1 25 PASS Cl 5 01 4 93 5 07 PASS Glu 1 21 1 17 1 25 PASS Back Page 1 of 2 QNext Q Up Za Home Fig 4 8 SRC Results 1 IQC gt SRC gt Results Fig 4 9 SRC Results is 2 4 6 After you have verified that the SRC information is correct the instrument begins the measurement process which is indicated on the display screen Fig 4 7 During this time about 60 seconds a progress bar is displayed 7 When the measurement is complete the unit displays the results Fig 4 8 and Fig 4 9 NOTE Results obtained are appl
131. assette Calibration In Progress Please Wait Calibrating asa Fig 5 7 Cassette Calibration Measurement Measuring 10 40 22 Jul Gas 83 Mix and Place the Sample Baro 732 4 Fig 5 9 Attach Capillary Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING The system will now check the integrity of the cassette and then calibrate Fig 5 7 For more information about calibration please refer to Chapter 4 Calibration and Quality Control NOTE The OPTI CCA TS will hold calibration for 10 minutes for all cassette types except B Lac B Lac cassettes will hold calibration for 2 minutes The OPTI CCA TS will beep warning you when only I minute remains on the calibration After this time elapses a message will be displayed to discard the cassette NOTE If tHb SO has been disabled see Section 3 3 2 2 you may attach the sample at any time during calibration and press Dr The sample will then be automatically aspirated after calibration and the measurement will begin After the successful calibration the status light will stop blinking and the display will prompt you to mix and place the sample Fig 5 8 Mix the syringe sample well by rolling it between the palms of your hands and inverting end over end e Sedimentation of blood cells causes alteration of tHb values Therefore mix the sample well just prior to analysis Using a capillary a syringe and adapter
132. ata to a computer the OPTI CCA TS communication port must be configured See section 3 3 3 5 and a physical connection to the receiving computer must be made Before exporting to the Compact Flash CF Card included in CF Export Kit BP7140 make sure that the Compact Flash card is properly inserted in the CF port 1 Inthe Ready display select lt Data Manager gt 2 Select lt Patient gt lt SRC gt or lt Controls gt Fig 4 32 3 Select the data to be exported and press Lei Eupen to start the data transfer Fig 4 33 A warning will be displayed asking you to confirm your choice Fig 4 34 4 15 4 CALIBRATION AND QUALITY CONTROL Enter Paseword If the password has been activated under lt Setup gt you will be asked to enter the password to initiate the procedure 4 Use the numeric keypad to enter the password OS TES T BR a Fig 4 35 4 5 6 1 2 3 0 Cancel OK Fig 4 35 Enter Password 4 16 Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling eee 5 1 NE i e 5 1 5 1 2 Sample Requirements i icrenkaeE aa a E E EEr de Aa Eea a Ean 5 1 5 1 3 Anticoagulants and Sample Collection Devices ioucii aora da innen clt hcec 5 1 SM ME d NENNT S PET TERCER HEN 5 2 5
133. aterial Fig 3 11 If the bar code is unavailable press the Edit button and enter the numbers using the keypad 6 Press Biss lto accept 7 Press lt Ranges 2 gt to go to the next display to enter the ranges for all other measured parameters available with this control material Fig 3 12 Enter 0 0 for unassayed parameters e You will find the assay ranges printed on the data sheet in the box of control material Alternately you may develop your own assay ranges from multiple measurements according to your hospital s procedures e Although it is recommended you review all analyte assay ranges you may press fd Save at any time after the bar code is scanned and the ranges will be accepted from the bar code To continue quality control programming repeat the above procedure for QC Level 2 and QC Level 3 Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 3 2 Customizing Patient Information 3 3 2 1 Selecting Which Patient Information is Requested and Printed Not Ready 10 40 12 Nov Patien QC Miscellaneous oc SRC Control Ratient Information Measured Calculated Parameters Parameters Normal Ranges Alam Limits Q Up Home Fig 3 13 Select Patient Entry Correlation Units S ace meo 0 2 Patent Information 12 Nov Info2 Infos Enable Setting Optional Required Patient ID iv Cc Cc Optional Required Operator ID c E tional Required
134. ation drops Decreased levels are found in severe vomiting severe diarrhea ulcerative colitis pyloric obstruction severe burns heat exhaustion diabetic acidosis Addison s disease fever and acute infections such as pneumonia Increased levels are found in dehydration Cushing s syndrome hyperventilation eclampsia anemia and cardiac decompensation Measurement Principle The CI ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion concentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion Like the pH optode the ion optodes do not need a reference electrode however several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA TS using the measured pH Measurement Range Range Resolution Low High Units 50 to 160 mmol L 1 0 1 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 80 0 2 105 0 2 130 0 2 mmol L Operator s Manual OPTI CCA TS CI 1 CHLORIDE ANALYTES Interferences The OPTI CCA TS
135. basis and with aqueous solutions for each new lot of cassettes Aqueous controls are portable and quite convenient to use with the OPTI CCA TS system however their low oxygen carrying capacity and temperature sensitivity is well known Measurements of such materials are more prone to pre analytic error as well as analyzer specific errors compared to similar measurements of whole blood The OPTI CCA TS system is no exception to this and demonstrates somewhat poorer PO precision with aqueous controls than with whole blood due to the large amount of plastic material comprising its disposable measurement chamber The OPTI CCA TS s tHb measurement is sensitive to pathologically rapid sedimentation rates of the erythrocytes often induced by excessive rate and amounts of rouleaux formation This is observable as rapid sedimentation and clarification due to erythrocyte aggregates falling to the bottom of the syringe within minutes of mixing The OPTI CCA TS breaks up most of the rouleaux and other aggregates by rapidly aspirating the whole blood sample with high shear rate however in rare pathologic cases the rouleaux aggregates persist or reform during the aspiration and cause a positive tHb offset of up to 3 g dL typically within the range 7 12 g dL Any measurement outside the Measurement Range will be indicated on the display as LOW for values lower than the range and HIGH for values above the range However the printed report will show out
136. ble anticoagulants The OPTI CCA TS Glu sensor does exhibit an interference from PO levels that exceed 700 mmHg The Glu sensor corrects for PO values up to 700 mmHg Glucose values are suppressed when PO values are gt 700 mmHg Glu 2 Operator s Manual OPTI CCA TS ANALYTES GLUCOSE Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments Glucose values are expressed in mg dL and mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS Level 1 mg dL 44 9 0 28 0 6 1 38 3 1 1 42 3 2 aqueous control solution mmol L 2 49 0 02 0 6 0 08 3 1 0 08 3 2 OPTI CHECK PLUS Level2 mg dL 102 8 0 38 0 4 2 87 2 8 2 90 2 8 aqueous control solution mmol L 5 70 0 02 0 4 0 16 2 8 0 16 2 8 OPTI CHECK PLUS Level 3 mg dL 252 4 1 7 0 7 12 4 4 9 12 5 5 0 aqueous control solution mmol L 14 01 0 09 0 7 0 69 4 9 0 69 5 0 Serum mg dL 71 9 0 3 0 4 1 7 2 4 1 8 2 5 mmol L 3 94 0 02 0 4 0 09 2 4 0 10 2 5 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of va
137. by glomerular failure often have altered concentrations of calcium phosphate albumin magnesium and pH Since these conditions tend to change ionized calcium independently of total calcium ionized calcium is the preferred method of accurately monitoring calcium status in renal disease Ionized calcium 1s important for diagnosis or monitoring of hypertension management parathyroidism renal diseases malnutrition kidney stones multiple myeloma and diabetes mellitus Measurement Principle The Ca ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion concentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion Like the pH optode the ion optodes do not need a reference electrode however several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA TS using the measured pH Measurement Range Range Resolution Low High Units 0 2 to 3 0 0 01 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 1 80 1 1 1 x0 1 0 7 x 0 1 mm
138. cidosis increased renal sodium conservation in hyperaldosteronism Cushing s syndrome inadequate water intake because of coma or hypothalamic diseases dehydration or excessive saline therapy The sodium value obtained may be used in the diagnosis or monitoring of all disturbances of the water balance infusion therapies vomiting diarrhea burns heart and kidney insufficiencies central or renal diabetes insipidus endocrine disturbances and primary or secondary cortex insufficiency of the adrenal gland or other diseases involving electrolyte imbalance Measurement Principle The Na ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion concentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion Like the pH optode the 1on optodes do not need a reference electrode however several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA TS using the measured pH Measurement Range Range Resolution Low High Units 100 to 180 1 0 1 mmol L Standard Re
139. ckage preventing sample aspiration e Press ok and discard cassette 7 DIAGNOSTICS AND TROUBLESHOOTING Lactate Setup ERROR Lactate Setup Failed Re run Cancel ERROR Wrong Different Lot m ERROR Gas Expired OK ERROR Cassette Misseat 1 Re insert Cassette OK Cancel This error message appears when the reproducibility of the OPTI Check controls during the lactate setup procedure is out of range e Re run scalar setup procedure Make sure to aspirate the OPTI Check directly from the ampoule e Re run the scalar setup using a different lactate cassette lot e Call Technical Support An incorrect cassette type or lot was scanned in during lactate setup e All cassettes used during lactate setup must be the same lot number e Make sure the cassette type is B Lac The gas bottle has expired or you have used an invalid bar code NOTE The gas bottle expires 9 months after installation or after exceeding the labeled expiration date whichever comes first e Check the gas bottle label Make sure it is for this particular gas bottle and the expiration date has not been exceeded If expired insert a new gas bottle e Check proper date setting in lt System gt Time and Date gt The cassette was not properly placed into the chamber or it was previously used e Open the SMC cover e Reinsert the cassette and verify proper seating e Press OK to continue OR e Pre
140. ctate BAe Cassette MEN Lac 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO 6 erisera a a ES THB SO2 1 Operator s Manual OPTI CCA TS A i ANALYTES pH pH Clinical Significance The pH value of the blood serum or plasma may be the single most valuable factor in the evaluation of the acid base status of a patient The pH value is an indicator of the balance between the buffer blood renal kidney and respiratory lung systems and one of the most tightly controlled parameters in the body The causes of abnormal blood pH values are generally classified as a primary bicarbonate deficit metabolic acidosis b primary bicarbonate excess metabolic alkalosis c primary hypoventilation respiratory acidosis d primary hyperventilation respiratory alkalosis An increase in blood serum or plasma pH alkalemia may be due to increased plasma bicarbonate or a feature of respiratory alkalosis due to an increased elimination of CO due to hyperventilation A decreased pH value acidemia in blood serum or plasma may occur due to an increased formation of organic acids an increased excretion of H ions in certain renal disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or may be chronic as the re
141. d Save to accept Fig 3 8 3 3 3 CUSTOMIZATION NOTE If previous SRC data exists the unit will prompt the user to either print and or delete this data from the database Yes No NOTE If no previous QC data exists in the database the print and delete display screens will be bypassed Setup QC Print Old SRC Data 6 Press e toobtaina printout of the old SRC database Setup QC Delete Old SRC Data 7 Press Yes to delete the old SRC database Ege To continue quality control SRC programming repeat the above procedure for all levels of SRCs 3 3 1 2 Setting up the Quality Control Material Lot and Level Not Ready 10 40 Patien OQC Miscellaneous Qc SRC Customizing Patient Information Measured 1 From the lt Ready gt display select lt System Manager gt and lt Setup gt 2 Enter the password if this security function has been activated under lt Setup gt 3 Select lt Control gt Fig 3 9 4 Scan the 36 digit bar code marked SCAN A Passer EMW parameters Parameters for the applicable level supplied with OPTI Rd CHECK or OPTI CHECK PLUS Preg ys 5 Scanthe second 36 digit bar code marked SCAN B supplied with the same OPTI CHECK Q gu or OPTI CHECK PLUS control lot These two bar codes contain all necessary lot information for each level and may be confirmed in the subsequent screens 6 When using OPTI CHECK PLUS scan th
142. d after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Total hemoglobin content linearity is established by the photometric determination of cyanmethemoglobin gt No standard method exists for the measurement of oxygen saturation Correlation Slope Intercept Coefficient Sy x Range n Total Hemoglobin 0 9839 0 165 0 99483 0 59 5 2 22 0 84 Operator s Manual OPTI CCA TS THB SO2 3 tHb SO ANALYTES Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood ctHb 1 0285 0 375 0 9778 0 47 6 0 16 1 103 SO2 0 8678 12 99 0 9738 0 73 73 100 103 A
143. d an ion impermeable membrane just as conventional PCO blood gas electrodes employ the Severinghaus CO electrode construction As such PCO optodes may suffer interference from volatile acids and bases in blood just as conventional PCO electrodes The PCO partial pressure is influenced by the local barometric pressure as dictated by Dalton s law The OPTI CCA TS incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS has been factory calibrated to the absolute barometric pressure Measurement Range Range Resolution Low High Units 10 to 200 1 0 1 mmHg Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 70 0 2 40 0 2 20 0 2 mmHg Operator s Manual OPTI CCA TS PCO2 1 PCO ANALYTES Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments PCO is expressed in mmHg Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 1 74 2 0 07 0 1 0 70 1 0 0 71 1 0 Level 2 45 5 0 05 0 1 0 27 0 6 0 28 0 6 Level 3 22 8 0 04 0 2 0 21 0 9 0 22 1 0 Serum 40 9 0 09 0 2 0 47 1 2 0 48 1 2 Reduced Bovine Hemoglobin 43 6 0 09 0 2 0 44 1 0 0 45 1 0 Solution All specific performance characteristics tests were run with d
144. d in whole blood at the CLSI recommended test level or higher and showed no interference to any measured analyte including blood gas electrolytes and tHb SO Bile Acids 30 umol dL Bilirubin 40 mg dL Beta Carotene 3 0 mg dL Hemolysis 10 During hemolysis K is released from the blood cells thereby increasing the measured K In the same manner protein released from the cells binds ionized Ca and decreases the concentration While an accurate value is reported it will reflect the actual changes caused by hemolysis Lipemia equivalent to 3000 mg dL triglycerides Elevated white blood cell count 30 000 WBC uL The following substances were tested in plasma at the CLSI recommended test level or higher and showed no interference to blood gas and electrolyte analytes Coumadin Warfarin 12 mg dL Dicumarol Dicoumarin 11 mg dL Procain Novacaine 13 mg dL Acetaminophen Paracetamol 20 mg dL The OPTI CCA TS system was evaluated for the interference of sample temperature on measurement iced samples No measurable sensitivity to sample temperature was found For more detailed information on interferences see analyte section of this Operator s Manual 5 Clinical and Laboratory Standards Institute CLSI Interference Testing in Clinical Chemistry Approved Guideline 2nd Edition CLSI document EP7 A2 CLSI Wayne PA 2005 Operator s Manual OPTI CCA TS 8 13 8 OPERATING PRINCIPLES 8 5 11 Accessories
145. d specimen tonometered to levels of oxygen to provide an oxyhemoglobin slightly greater than and slightly less than 50 with pH and PO held constant at 7 4 and 40 mmHg respectively the OPTI CCA TS allows for the estimation of P50 from measured SO PO and pH Ifa measured SO is not available the P50 value may be input via keypad For Adult hemoglobin P o 26 7 10l gP02 12P02 where lg Po 69 172 2 9 ge 10096 SO mmHg CLSI Blood Gas and pH Analysis and Related Measurements Approved Guideline NCCLS document C46 A 2001 Operator s Manual OPTI CCA TS A 11 APPENDIX A TECHNICAL SPECIFICATIONS AaDO pH cH PCO PO For Fetal hemoglobin P 25 0 10 8P02 1sP0 where _ lgQ 4 113 lg PO Se SO l 10094 0 mmHg The alveolar to arterial oxygen tension gradient PAO PaO is the difference between the alveolar oxygen tension estimated above and the measured oxygen tension of arterial blood PAO P oa 47 FIO PACO FIO 1 FIO R mmHg PACO PaCO alveolar PCO Apply above equation for PAO 2 PO otherwise PAO PO pH corrected to patient temperature other than 37 C pH pH 0 0147 0 0065 pH 7 4 t 37 pH unit 7 Concentration of hydrogen ions corrected to patient temperature other than 37 C cH 109 nmol L PCO value corrected to patient temperature other than 37 C PCO PC
146. defined way with the blood ctHb and SO and is used in their measurement The output signal of the detectors is converted by the microprocessor to a numeric readout in conventional units of measure and displayed on the front of the device Other values commonly used for the assessment of oxygen and acid base status are calculated from these measured values 8 2 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES 8 4 Specimen Collection and Handling 8 4 1 Safety Universal precautions must be observed when collecting blood specimens It is recommended that all blood specimens be handled as if capable of transmitting human immunodeficiency virus HIV hepatitis B virus HBV or other bloodborne pathogens Proper blood collection techniques must be followed in order to minimize risk to the laboratory staff and gloves should be worn Please refer to CLSI document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition March 2005 for further information on safe handling of these specimens 8 4 2 Sample Requirements Refer to CLSI document H11 A4 Procedures for the Collection of Arterial Blood Specimens Approved Standard Fourth Edition September 2004 for detailed information on sample collection storage and handling Blood sampling for analysis must be performed under proper medical supervision with details of collection including sampling devices site selection sam
147. dinassestataneaundsansseuondmuattnevaecatind 7 16 1 2 10 Checkingthe Factory co ee MT t 7 17 7 2 Checking the Bar e E 7 17 7 2 12 Checking the Printer RR T TRE 7 18 Ze Checking the OptICS Me 7 19 L4 Checking the RS232 IptSr abe i oon pao ren aA N Ea aa 7 20 P2210 Checking KE ie 7 21 1 2 16 Checking the tee 7 22 7 2147 Checking The B Te 7 22 12 18 Checkingthe TOUCH E 7 23 T2 V9 GaS Te m TT 7 24 7 2 20 Lactate Gen 7 25 7 2 21 Checking the Ethernet Interface crimes tnb nte bake Rx ER nS un eiiiai 7 27 Operator s Manual OPTI CCA TS Hl TABLE OF CONTENTS 2 22 Calibratioti FRepOFES dicun dee Pe orte e oan ca hbo eu needa eee dees 7 28 7 2 22 1 Patient Calibration Report sriid aa a aaae emen nnne n nen 7 28 7 2 22 2 SRC Calibration Report riii iieri pet itti norit ah eaae dreien ei EAR E YN Ur Yin SABE EE EA ERR he 7 29 7 2 22 3 Control Calibration Report 7 30 pur Error LOG m 7 31 7 2 22 5 Configuration Reno 7 32 7 2 22 0 Maintenance LOG wisi re ie ree etes euren ex E RD La e eth alu AE 7 32 7 3 Troubleshooting Procedure for tHb SO esesseeesesess 7 33 7 4 Troubleshooting Procedure for Bar Code Scanner 7 34 8 OPERATING PRINCIPLES raro nianu or pp aui aa are EEN EEEEgeEE cA 8 1 81 Intended c 8 1 8 2 Principles OF Procedure eiie rre Ere ERR eege 8 1
148. display select QC Manager gt e Inthe lt QC Manager gt menu select lt tHb Calibrator gt Fig 2 13 e Use the numeric keypad to enter the password factory default 404 Fig 2 14 e Use the alphanumeric keypad to enter the Operator ID or press ox to bypass this function Fig 2 15 e If Secure Op IDs is activated under Setup see Section 3 3 2 4 3 your 4 digit PIN will be required in place of your Operator ID 2 7 2 SETUP 2 8 Ready 10 40 12 Nov Select tHb Calibration Method Fig 2 16 Select tHb Calibrator Enter Lot Number 7 8 9 alsje EEE SEI Cancel OK Fig 2 17 Enter Lot Number Not Ready 10 40 12 Nov Open Cover Cancel Fig 2 18 Open Cover e Select lt tHb Calibrator gt Fig 2 16 e Enter the lot number of the Calibrator cassette located on the top surface of the cassette and press ox Fig 2 17 e Atthe prompt open the SMC cover by pressing the button Fig 2 18 Operator s Manual OPTI CCA TS Clean Optics and Inside of Cover Fig 2 19 Clean Optics and Inside of Cover Not Ready 10 40 12 Nov Open Pouch and Wipe Cassette am d Insert Cassette Cancel Fig 2 20 Wipe and Insert Cassette Not Ready Close Cover Fig 2 21 Close Cover Operator s Manual OPTI CCA TS 2 SETUP Gently clean the optics window and the inside top cover of the sample chamber with a so
149. dy 10 40 12 Nov Sensors Contro Tess Fan Gas Valve Off Closed Cassette Valve Drive Position o0 t FSet Q Up Home Fig 7 10 Valve Drive 7 16 The purpose of this test is to check for proper function of the gas valve From the Ready display press System Manager and Diagnostics e Select the Control tab e Press the Open Closed button under Gas Valve to start the test Fig 7 9 e A faint hissing sound may be heard with the pump cartridge removed and the gas valve open e Press UP to return to the System Screen This diagnostic checks the proper operation of the cassette valve drive mechanism From the Ready display press System Manager and Diagnostics e Select the Control tab Press Z Edt to start the test Fig 7 10 e Enter the various positions allowed positions are 6 and verify the valve drive moves smoothly and precisely e Press Q ki to return to the System Screen Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 10 Checking the Factory Settings Syste m gt Diagnostics Not Ready 10 40 12 Nov Sensors Contro Tess This lt Fset gt function Fig 7 11 is designed Fan Gas Valve exclusively for use by authorized OPTI Medical Off Closed personnel Cassette Valve Drive Position oo Edit Q Up Py Home Fig 7 11 Factory Settings 7 2 1
150. dy Time Interval c e e e New Lot Lockout Enable r Qoa H Save Q Up Home Fig 3 33 Select QC Lockout Operator s Manual OPTI CCA TS 3 CUSTOMIZATION This menu allows the facility to lock out operators unless some form of QC has been run OPTI Medical recommends option 1 and option 3 as described below Each facility should develop their own policies on the frequency and type of QC based on the regulatory requirements The instrument is factory set with lock out options turned off To activate these options e Select QC Lockout gt in the Security menu Fig 3 33 Option 1 lt SRC Lockout Enable Under this option you can require that one two or three levels of SRCs must be run at regular intervals If the selected number of SRCS is not run patient measurements will not be allowed lt 8hr gt Requires SRCs to be run every 8 hours 12hr Requires SRCs to be run every 12 hours 24hr Requires SRCs to be run every 24 hours 7dy Requires SRCs to be run every 7 days 1 Select the desired option 2 Press Bi to accept the changes 3 Press C uh m return to the Setup screen or f Pene to return to Ready NOTE The selected time interval starts with the time this feature is activated Option 2 Control Lockout Enable Under this option you can require that one two or three levels of liquid controls must be run at regular intervals If the selected nu
151. e Yes No Purging Gas Ready xX 10 40 22 Jul ae Scan Cassette Barcode Baro 732 4 Manual Entry Last Entry Data System Manager TEL Manager Fig 2 10 Ready screen Operator s Manual OPTI CCA TS 2 SETUP e Insert the gas bottle in its housing and turn clockwise until fingertight Fig 2 9 NOTE The gas bottle expires 9 months afier installation or after exceeding the labeled expiration date whichever comes first NOTE The bar code contains expiration information The OPTI CCA TS will alert the operator two weeks prior to expiration of the gas bottle as a reminder to order a replacement gas bottle e When this display appears press Mad to install a new gas bottle NOTE If after the initial installation you need to remove a gas bottle and reinstall the same bottle respond No to the prompt New Gas Bottle gt The next screen will prompt you to enter the number of weeks in service using the numeric keypad See section 6 5 3 Here you may refer back to the installation date which was recorded on the gas bottle The OPTI CCA TS will now begin to warm up and perform a gas purge which will be indicated on the status bar at the bottom of the screen Once the warm up is complete the Ready display appears Fig 2 10 2 5 2 SETUP 6 Installing the Printer Paper e Place paper into the paper tray e With the OPTI CCA TS switched on thread the
152. e information may be recalled by pressing the Last Entry button in the lt Ready gt screen The analyzer will then identify the lot number and prompt you to open the cover wipe and insert the cassette and close the cover Enter your Operator ID or four 4 digit PIN if requested 4 Insert the cassette as follows NOTE NOTE NOTE NOTE Open the OPTI Sensor Cassette packet and remove the cassette from the pouch Fig 5 5 After opening the pouch proceed with the following steps immediately The cassette should be run immediately after opening the pouch but no later than 15 minutes after opening For sample introduction with a capillary tube or a ComfortSampler remove the syringe adapter before placing the cassette into the chamber If possible avoid tearing the bar code when opening the cassette pouch Gently wipe both sides of the cassette with a clean dry cloth to remove excess moisture Insert the cassette in the chamber Press down to ensure the cassette is properly seated Fig 5 5 Close the SMC cover by pressing it down firmly Fig 5 6 The green status light starts to blink indicating that the SMC cover should not be opened during this time If the SMC cover is opened while the green status light is blinking the cassette calibration will be cancelled and the cassette must be discarded Operator s Manual OPTI CCA TS Measurement Measuring 10 40 22 Jul ES Baro C
153. e third 36 digit bar code marked SCAN C for the applicable level Fig 3 9 Select Control NOTE If bar code is not available press Manual Entry on the Scan Barcode screen and manually enter control data 3 4 Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 3 1 2 1 Entering Control Expiration Date Type and Assay Ranges Syste m gt Setup gt Control Not Ready 10 40 12 Nov Level Rangest Ranges2 Level 3 3 Lot Number Edt Expiration edt i OPT CHECK Plus Other Type z amp ycancel fp Save Up Home Fig 3 10 Confirm Lot Information Setup QC Print Old QC Data Setup QC Delete Old QC Data Operator s Manual OPTI CCA TS When you open a new box of OPTI CHECK OPTI CHECK PLUS or another recommended product the lot number should be entered into the analyzer along with the target ranges Each QC level of control has its own unique lot number printed on the information sheet contained in the control box NOTE OPTI CHECK and OPTI CHECK PLUS Quality Control materials are designed for your OPTI CCA TS and have assigned assay ranges for each measured parameter Do not use a control material that contains dyes fluoro carbons or silicones as these constituents will affect the results reported NOTE The procedure for programming QC ranges as described below is identical for all levels 1 From the previous bar code scans confirm lot number expira
154. e Press Up o return to the System Screen 7 2 5 Verifying Barometric Pressure System Diagnostics This menu displays the current barometric pressure Not Ready 10 40 12 Nov Sensors Control Tess From the Ready display press Hess ee lt System Manager gt Diagnostics gt Optics OPTIC2H GUI 3 000020 2 00 0001 e The Miscellaneous section will show the Temperature Readings Top Plate 317 C Ambient DEE current barometric pressure Fig 7 6 Bottom Plate 31 7 C Gas Level MEE Hon ex New e Ifthe barometric pressure requires adjustment LEDs refer to Setup Section 3 3 3 2 Entering the Front 1534 Cassette Misseat Yes Rear lon 1436 Cassette Detect 760 6 V over Barometric Pressure for setting the barometer Miscellaneous Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V Fig 7 6 Barometric Pressure 7 14 Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 6 Checking the Battery Voltage Syste m gt Diagnostics Not Ready 10 40 12 Nov Sensors Contro Tess Versions OPTI CCA 3 00 0020 2 00 0001 Optics OPTIC2H GUI 3 00 0020 2 00 0001 Temperature Readings Top Plate 31 7 C Ambient 317 C Bottom Plate 31 7 C Gas Level Gas Pressure High 99 New LEDs Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 iscellaneous Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V
155. e capillary is cut may cause damage to the OPTI cassette fill port Use only capillary tubes with fire polished ends to prevent damage to the cassette If a mixing flea is used as required in some capillary tubes take care to remove the flea prior to sample introduction to avoid damage to the cassette Specimens collected in capillary tubes are stable at room temperature for up to 30 minutes after collection because of the rapid cooling of the sample accomplished during filling Cooled samples provide relevant glucose values for up to 30 minutes uncooled samples for up to 10 minutes Serum must be separated within these time limits 5 1 6 OPTI Medical ComfortSamplers Blood may be collected for analysis on the OPTI CCA TS with the OPTI Medical ComfortSampler to provide a filled shielded capillary tube After collection the ComfortSampler should be capped and transported in a horizontal position to the instrument for analysis within 30 minutes as with all specimens collected in capillary tubes Cooled samples provide relevant glucose values for up to 30 minutes uncooled samples for up to 10 minutes Serum must be separated within these time limits 5 2 Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 7 Handling and Storage of Samples Please refer to CLSI Document H18 A3 Procedures for the Handling and Processing of Blood Specimens Approved Guideline Third Edition November 2004 for a detailed discus
156. e laboratory staff and gloves should be worn Please refer to CLSI document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition March 2005 for further information on safe handling of these specimens 5 1 2 Sample Requirements Refer to CLSI document H11 A4 Procedures for the Collection of Arterial Blood Specimens Approved Standard Fourth Edition September 2004 for detailed information on sample collection storage and handling Blood sampling for analysis must be performed under proper medical supervision with details of collection including sampling devices site selection sample handling documentation and specific procedures used approved by the personnel responsible 5 1 3 Anticoagulants and Sample Collection Devices Lithium heparin is the only acceptable anticoagulant for blood gas and electrolyte analysis Lithium heparin sodium heparin or balanced heparin salts are the only acceptable anticoagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and should not be used Lithium heparin should not be used for samples taken also for analysis of lithium Operator s Manual OPTI CCA TS 5 1 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 4 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the amount of blood requir
157. e printed All the measurements in between will be selected Press Q to select all results Press _GaPrint to print your selection Press the Statistics button to print a statistical report of the last 30 control measurements or more if available in database After printout the database can be deleted by pressing gt lt Delete Before the database is deleted enter the password to initiate the procedure if a password has been activated under Setup 10 Press fa Home to return to the Ready display Operator s Manual OPTI CCA TS 4 5 5 Sending Data to a Computer 10 40 12 Nov Stirement Reports Statistics Patient SRC Controls Patient SRC Controls Errors Miscellaneous Reports Configuration Maintenance Qu Fy Home Fig 4 32 Select Data Data gt Control Measurement Ready 10 40 12 Nov Level Date D D R Jj View 1 1 12 Feb L 23 Print 2 1 12 Feb ue 3 1 12 Feb p ipee D Feb Fe e All 3v Statistics E Q Up Fy Home Fig 4 33 Export Data 5 1 12 Feb Down Lo WARNING Export Selected Control Data Yes No Fig 4 34 Export Selected Data Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL The OPTI CCA TS provides you with the ability to export Patient and QC information to a connected computer or HIS LIS Prior to sending d
158. ect operation Make sure the pump rotates smoothly without excessive noise In addition run one sample in control mode Make sure the control measurement passes without errors To change the gas I O port 1 Open the SMC cover Remove the black I O port by grasping it with a hemostat or tweezers and firmly pulling upward Fig 6 20 Discard the old part Install the new gas I O port with the rounded surface pointing up and press them into the recess When fully seated the I O port is approximately 1 8 inch 3mm above the surrounding surface Perform a lt Pump Test gt see section 7 2 16 to ensure correct operation Make sure the pump rotates smoothly without excessive noise In addition run one sample in control mode Make sure the control measurement passes without errors Operator s Manual OPTI CCA TS 6 MAINTENANCE 6 5 As Needed Maintenance 6 5 1 Changing the Gas Bottle wold A ue The calibration gas bottle is designed to provide E approximately 100 sampling operations depending Gas A on the mode of use The following message will alert the operator that the gas bottle needs to be 24 Not Ready changed Fig 6 21 Low Gas To change the gas bottle New Gas Bud l Press New Gas Bottle Data ac System 2 Unscrew the gas bottle by turning the knob on Manager Manager Manager the bottom counterclockwise Al M 3 Takea new gas bottle and remove its cap 4 When prompted Fig 6 2
159. ects the measurement of total hemoglobin 8 4 5 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume filled of 125 uL The OPTI Medical capillary tubes MC0024 are ideally suited with a minimum volume filled of 200 uL The capillary tubes for pH blood gas and electrolyte analysis should not be used for samples taken for the analysis of lithium Operator s Manual OPTI CCA TS 8 3 8 OPERATING PRINCIPLES Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture The puncture should be made deeply enough to ensure a free and rapid flow of blood Do not use clay capped capillary tubes as the rough broken edge left when the capillary is cut may cause damage to the OPTI cassette fill port Use only capillary tubes with fire polished ends to prevent damage to the cassette If a mixing flea is used as required in some capillary tubes take care to remove the flea prior to sample introduction to avoid damage to the cassette Specimens collected in capillary tubes are stable at room temperature for up to 30 minutes after collection because of the rapid cooling of the sample accomplished during filling Cooled samples provide relevant glucose values for up to 30 minutes uncooled samples for up to 10 minutes Serum must be separated within these time limits 8 4 6 OPTI Medical ComfortSamplers
160. ed to analyze the fluorescence data from the Lactate sensor applies a correction based on the measured total hemoglobin tHb value to compensate Thus the reported lactate value for the B Lac cassette has no significant interference from tHb in the range 5 g dL to 20 g dL For samples with tHb values greater than 20mg dL the Lactate value is not reported The following substances were tested following the CLSI guideline EP7 A2 Chemical Test level d max Lactate Level Interference Concentration mM 2 NO Acetaminophen 1 66 mM 0 2mM 5 NO 2 NO Acetylsalicylic acid 3 33 mM 0 2mM 5 NO 2 NO Ascorbic acid 0 23 mM 0 2mM 5 NO 2 NO B Hydroxybutyric acid 16 03 mM 0 2mM 5 NO 2 NO Bilirubin 0 26 mM 0 2mM 5 NO 2 0 4 mM Cardiogreen 0 0065 mM 0 2mM 5 1 1 mM 2 NO Cystein 6 41 mM 0 2mM 5 NO 2 NO Ethanol 86 8 mM 0 2mM 5 NO 2 NO Evans blue 0 0104 mM 0 2mM 5 NO 2 1 4 mM Glycolic acid 10 mM 0 2mM 5 1 0 mM 2 NO Halothane 0 759 mM 0 2mM 5 NO 2 NO Ibuprofen 2 43 mM 0 2mM 5 NO Lac 2 Operator s Manual OPTI CCA TS ANALYTES Chemical Test level d max Lactate Level Interference Concentration mM 2 NO Intralipid 1 0 2mM 5 NO 2 0 6 mM Methylene Blue 0 125 mM 0 2mM 5 1 1 mM 2 NO Sodium Chloride 20 mM 0 2mM 5 NO Additional interferences were found with the use of Sodium Fluoride NaF collection tubes
161. ed to minimize the effects of dilution of the blood by the anticoagulant solution Although plastic syringes are commonly used for collection of blood specimens for blood gas analysis there have been reports in literature regarding the use of plastic syringes when PO values higher than normal are expected Particular attention should be paid to cooling blood samples in ice water because of the CO and oxygen solubility in some plastics If blood specimens are expected to have very high PO values care should be taken to analyze the specimen as quickly as possible following collection to avoid the need for cooling Attention should be paid to thorough mixing of whole blood samples prior to analysis since sedimentation of blood cells affects the measurement of total hemoglobin 5 1 5 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume filled of 125 uL The OPTI Medical capillary tubes MC0024 are ideally suited with a minimum volume filled of 200 uL The capillary tubes for pH blood gas and electrolyte analysis should not be used for samples taken for the analysis of lithium Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture The puncture should be made deeply enough to ensure a free and rapid flow of blood Do not use clay capped capillary tubes as the rough broken edge left when th
162. efault instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Precision and Recovery on Whole Blood Whole blood was tonometered at 37 C to various levels of gravimetrically prepared gases with CO concentrations certified to 0 03 absolute by the manufacturer For each tonometered level 3 replicates were run on each of three OPTI CCA TS systems All values are in mmHg Expected n Observed Swr bias Recovery 10 4 9 10 9 0 28 0 5 105 96 27 6 9 29 3 0 36 1 7 106 96 27 8 9 29 1 0 41 1 3 105 95 45 0 9 44 2 0 33 0 8 98 60 6 9 60 3 0 55 0 3 100 96 69 2 9 69 4 0 55 0 2 100 96 80 1 9 81 2 0 68 1 1 101 96 100 8 9 102 4 1 15 1 6 102 96 201 3 9 195 5 1 21 5 8 97 96 PCO2 2 Operator s Manual OPTI CCA TS ANALYTES PCO Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods PCO linearity is established against values determined on whole blood tonometered to gravimetrically prepared gases with CO concentrations certified to 0 03 absolute by the manufacturer and measured on three OPTI CCA TS systems Correlation Slope Intercept Coefficient Sy x Range n 0 9681 2 148 0 99967 1 53 11 201 81 Correlation to Other
163. elation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer B 1 03 0 21 0 996 0 016 6 578 7 766 174 Analyzer C 1 03 0 19 0 996 0 015 6 582 7 701 174 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological PH Values Sensors and Actuators 9 p 85 1986 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b pH B 4 Operator s Manual OPTI CCA TS ANALYTES PCO PCO 2 Clinical Significance The PCO value of arterial blood is used to assess how well the body eliminates carbon dioxide a by product of metabolism A PCO value below the normal range is termed respiratory alkalosis and indicates hypocapnia a condition caused by increased alveolar ventilation such as hyperventilation An arterial PCO above the normal range is termed respiratory acidosis and indicates hypercapnia a sign of ventilatory hypoventilation and failure resulting from cardiac arrest chronic obstructive lung disease drug overdose or chronic metabolic acid base disturbances Measurement Principle The PCO optode measurement principle is based upon placing a pH optode behin
164. enance Fig 3 47 In the Maintenance menu Fig 3 48 you can select Replace Pump Reminder to alert you when the peristaltic pump needs replacement If you enable the option Cleaning Reminder the system will alert you when weekly or monthly cleaning is due Select Monthly cleaning if the analyzer is not used weekly Refer to Chapter 6 for maintenance procedures Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 3 3 8 Selecting a Language This menu lets you choose the language you want the OPTI CCA TS to use for displays and printouts Not Ready 10 40 12 Nov Patient QC Miscellaneous 1 From the Ready display select lt System Manager gt and lt Setup gt Security Hardware Printer 2 Inthe lt System Setup gt menu press the Miscellaneous tab and then Language Fig 3 49 Maintenance Q Up Home Fig 3 49 Select Language iSystem gt Setup gt Language Not Ready 10 40 12 Nov elect Language 3 Select the desired language Fig 3 50 Francais Cc Dee Italiano c 4 Press N ae to accept the changes J zyk polski Portugu s Espano f Japaneses 5 Press UP lto return to the lt Setup gt screen Chinese c or Home t return to Ready gs Qu Fy Home Fig 3 50 Select Language Operator s Manual OPTI CCA TS 3 27 4 CALIBRATION AND QUALITY CONTROL 4 CALIBRATION AND QUALITY CONTROL
165. etected Check Cassette EE Ol WARNING Hb Calibration Expires soon K A ERROR List is Full OK F ERROR No Patient ID Entry OK m ERROR Bad Sensors Discard Cassette OK T ERROR Possible Clot Discard Cassette OK Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING A bubble was detected at the light gates e Remove the cassette e Press OK to continue e Examine the cassette and look for bubbles If bubbles are present over a sensor rerun the patient or QC sample This display only appears once prior to the three month expiration of the tHb Calibration and acts as a reminder to run the tHb Calibrator e Press OK m continue The number of secure users operator IDs stored in memory equals 300 e Press OK m continue e Delete unused Operator IDs from memory See Section 3 3 3 1 3 If Patient ID Operator ID and or Accession No is required and not entered this error will be displayed e Press OK to edit the patient data and add the required information A new printout will be given with the required information NOTE If the required information is not entered results will be displayed and printed out however the system will not return to Ready Two or more measured parameter sensors are bad e Press OK discard the cassette and repeat the test with a new cassette A sample error has occurred This may be due to a clot or blo
166. eters ac Patient Entry Syste m gt Setup gt Calculated Parameters Not Ready 10 40 12 Nov Cassette Type B Blac E E C E Ca E Glu E BUN e Cc Lf r f C Cc Enable Enable Enable BE r stHCO3 SO2c tCO2 LI st pH r AaD02 r HCO3 r cH P 02Ct r BB r AnGap psoct T BEact TI nass F BEecf 7 Het c r amp ycancel Defaults H Save oul a Fig 3 20 Select Parameters 3 10 With this menu you can select the calculated parameters to be printed on the patient report The printout order is fixed however calculated parameters may be selected for inclusion in or exclusion from the printout NOTE The display will always let you view all available calculated parameters From the lt Ready gt display select System Manager and Setup In the System Setup menu press Calculated Parameters Fig 3 19 Select the cassette type Fig 3 20 Select the parameters to be printed Press lS to accept the changes Press Up m return to the Setup screen or Home to return to lt Ready gt Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 3 2 4 Setting Normal Ranges or Alarm Limits Not Ready 10 40 Patient Miscellaneous 12 Nov ac SRC Control Customizing Patient information Measured Patient Entry Parameters Calculated Parameters Normal Ranges Correlation Units Alarm Limits t Q Up Home Fig 3 21 Select Normal Ranges
167. etting up your analyzer and will help you start analyzing samples As you become familiar with the operation of the unit you should use the manual as a reference for day to day routines and as a guide for maintenance and troubleshooting How to use this manual If you have an analyzer that is not yet set up you should begin by reading Chapters 1 and 2 For programming and quality control functions read Chapters 3 and 4 Information on analyzer operation and maintenance is contained in Chapters 5 and 6 Detailed service information and operating principles can be found in Chapters 7 and 8 TABLE OF CONTENTS Table of Contents Symbol Definitions 4er V xi nro Mee VII hirci eR eee VII How t se this VAN heel Nee OR VII T INTRODUCTION uiii cnuscvccc Eege 1 1 1 1 Intended CT 1 1 1 2 Principles of Operation vissi eege anaa 1 1 EC fto 1 2 1 4 Analyzer Components eeeeeeeeeeeeeeeeeeeeeneeennnnnnn enhn nnn nenne nennen nnn 1 3 MERCI ro TG von n v Gne 1 7 2 SETUP aaa ses 2 1 2 1 Important Safety INStrUCtIONS eee eee tener eee eeeeeeeeeeeeeeeeeesneneenenneeeeeeeeees 2 1 22 CHOOSING a LOCAU OM iuis ii aeit uns c occ ceccedecusves vandvenntendeendedaueccteactehewdenecede 2 1 2 3 Setting up the OPTI CCA TS AmalyZer cccccccccccceeeeeeeeeeeeeeeeeeeeneeeneeeeeeeeeeeeeees 2 2 3 CUSTOMIZATION H 3 1 31 Data NN tics
168. f the blood is defined as the pH value of a blood sample which has been equilibrated at 37 C with a gas mixture having a PCO 40 mmHg st pH 0 8262 0 01296 tHb 0 006942 BE Ig 0 025 PCO pH pH unit 5 Burtis AB Ashwood ER Tietz Textbook of Clinical Chemistry 2 Ed Philadelphia W B Saunders 1994 p 46 Marsoner HJ Quantities and Algorithms Related to Blood Gas and Acid Base Analysis AVL Medizintechnik Graz 1995 A 8 Operator s Manual OPTI CCA TS HCO APPENDIX A TECHNICAL SPECIFICATIONS Bicarbonate concentration in plasma El pH 6 105 HCO 0 0307 PCO 10 mmol L st HCO tCO BE BE ecf Standard bicarbonate of the blood defined as the plasma bicarbonate concentration in blood which has been equilibrated at 37 C with a gas mixture having a PCO 40 mmHg 4fn stpH 6 022 st HCO 10 p mmol L 6 Total concentration of CO in plasma the sum of dissolved CO and bicarbonate tCO HCO 0 0307 PCO mmol L The base excess of the blood results from a calculation to determine the titratable base of the blood which in principle is measured by titration of the blood with a strong acid or base to a pH of 7 4 with PCO 40 mmHg at 37 C BE 1 0 014 tHb a 43 tHb 7 7 pH 7 4 24 8 HCO mmol L 7 The base excess of extracellular fluid is a quantity that reflects only the non respiratory components of acid base
169. ference Cassette SRC Limit Values LOW NORMAL HIGH Units 125 0 2 145 0 2 165 0 2 mmol L Operator s Manual OPTI CCA TS Na 1 SODIUM ANALYTES Interferences The OPTI CCA TS Na sensor has no measurable interference from K variation within the range 0 8 10 mmol L The OPTI CCA TS Na sensor does exhibit a small interference from Li Li levels of 1 0 2 5 and 6 4 mmol L will cause a positive Na bias of 0 9 1 2 and 1 3 mmol L respectively A syringe sample anticoagulated with typical amounts of lithium heparin has 1 4 mmol L of lithium which offsets the measured Na by less than 1 To minimize the interference from lithium use syringes containing the lowest acceptable heparin level Carefully follow the syringe manufacturer s recommendation regarding proper filling of the syringe A partially filled syringe results in excessive lithium concentration The OPTI CCA TS Na results include an appropriate correction for pH at all values of pH This correction may introduce an extra source of variability at the extreme values Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogeneous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amo
170. following reports Patient lt SRC gt Controls and Errors The Patient Calibration Report contains information about the measured signal in millivolts and drifts observed during measurement To print a patient calibration report select Calibration Reports gt Patient in the Data screen Fig 7 43 In the Data Patient Diagnostics screen Fig 7 44 select the desired measurement and press the View button to display the results Fig 7 45 Use the rue and Dow buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 44 To print groups of results highlight the first measurement to be printed press g Mak then select the last measurement to be printed All the measurements in between will be selected Press to select all results Press _GaPrint to print your selection Press UP to return to the Data screen Operator s Manual OPTI CCA TS 7 2 22 2 SRC Calibration Report Ready 10 40 12 Nov Measurement Reports Statistics Patient SRC Controls Miscellaneous Reports Configuration Maintenance Q Up Fy Home Fig 7 46 Select SRC Data gt SRC Diagnostics Ready 10 40 12 Nov Level Date Jj View 1 1 12 Feb INE L1 1 7 5 3 1 Fe i133 Terres e 73 13 76 ES 8 1 12 Feb Down Q Up Home
171. ft lint free cloth Fig 2 19 Press OK Gently wipe both sides of the Calibrator Cassette with a clean dry cloth and examine it to ensure it is clean Insert it into the chamber and press down to properly seat the cassette Fig 2 20 Close the sample chamber cover Fig 2 21 2 9 2 SETUP 2 10 Not Ready 10 40 12 Nov tHb Calibration In Progress Please Wait Calibrating Ee Fig 2 22 tHb Calibration OPTI Medical OPTI CCA Calibration Report DD MMM YY HH MM S N XXXX Version ABCX XX Operator ID HbCal Type tHb Calibrator HbCal LOT XXXXXX HbCal Date DD MMM YY Calibration Results Meas d Cal d tHb 12 9 13 0 S02 74 6 74 9 Calibration Factors OLD F1 1 023 F2 1 087 F3 1 089 F4 0 000 NEW CO ta to to 014 080 094 000 Fig 2 23 HbCal Report After the cover has been closed the instrument will automatically detect the presence of the calibrator cassette and begin calibration Fig 2 22 e After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette e Place the calibrator cassette back into its pouch immediately after removal from the instrument NOTE Make sure to keep the calibrator cassette with the instrument at all times The unit will now begin printing the tHb Calibration Report showing calibration results and calibration factors Fig 2 23 OPTI Medical recommends that you
172. g 1 12 The sample fillport is contained in the OPTI Cassette and projects from the chamber for easy automatic sampling It includes a removable syringe adapter for sampling with a syringe For sampling with a capillary simply remove the adapter Fig 1 13 NOTE The syringe adapter may be removed while the cassette is inside the SMC NOTE DO NOT INJECT the sample It will be aspirated automatically 1 7 1 INTRODUCTION 1 8 Standard Reference Cassettes SRCs Fig 1 14 Standard Reference Cassette tHb Calibration Cassette Fig 1 15 tHb Calibration Cassette Gas Bottle Fig 1 16 Gas Bottle Congratulations Standard Reference Cassettes SRCs Fig 1 14 are reusable sensor cassettes used for daily quality control testing SRCs can be found in the storage compartment of your analyzer Each new analyzer comes with a level 1 and a level 3 SRC Level 2 SRCs are available if desired SRCs should be kept in their pouches when not in use see section 4 5 for instructions The reusable tHb Calibration Cassette Fig 1 15 is used for the quarterly calibration of the OPTI CCA TS Analyzer See Section 6 3 Quarterly Maintenance Performing tHb Calibration During calibration the OPTI CCA TS uses a precision gas which is completely self contained in a disposable low pressure bottle The bottle is inserted on the right side of the unit after scanning the bar code Fig 1 16 You have just learned the
173. h a different cassette turn the power off and wait 30 seconds Then then turn power back on and retry The instrument did not calibrate due to problems with the cassette or instrument e Press OK discard the cassette and repeat the test with a new cassette e Ifthe message still appears with a different cassette turn the power off and wait 30 seconds Then turn the power back on and retry 7 DIAGNOSTICS AND TROUBLESHOOTING E ERROR Dirty Optics Clean Cassette Optics OK E ERROR Calibration Expired Discard Cassette OK I ERROR Unstable Sensors Discard Cassette OK au ERROR Short Sample Discard Cassette OK P ERROR Invalid Barcode OK 7 6 The optics or cassette are dirty e Remove the cassette Inspect the cassette and optics on bottom and top plate Clean if necessary e Reinsert the cassette and press OK to rerun the test The cassette has been holding the calibration for more than 10 minutes without a sample being attached e Press OK and discard the cassette A sample error has occurred This may be due to a clot or large air bubble if two or more sensors are unstable e Press OK and discard the cassette e Check the sample and rerun with a new cassette The system was not able to aspirate enough contiguous sample fluid to cover the optode sensors after multiple aspiration attempts If a bubble was detected the system attempted to restart the
174. he bar code was invalid e Verify that Scan A gt and Scan B of the QC material is from the same level and lot number e Press OK lin continue The cassette placed in the SMC is invalid e Verify that the cassette placed in the SMC is a valid tHb calibrator e Press OK to continue The QC lot 1s invalid e Press OK to continue e Configure the control material under Setup and retry The SRC type is invalid e Press o to continue e Remove the SRC e Configure the SRC data in Setup and retry 7 7 7 DIAGNOSTICS AND TROUBLESHOOTING Bi DE ERROR Expired SRC Check Time and Date K ERROR Need Setup QC OK i o ERROR Dirty Optics Discard Cassette OK A ERROR Op ID already Exists o A i ERROR Invalid PIN K ERROR PIN already Exists S 7 8 The SRC expiration date has been reached e Press OK uid remove the SRC e If the error message appears again check the date in System gt Time and Date e Configure a new SRC under Setup and retry A measurement of QC materials either liquid or SRCS was attempted prior to setting up e Press OK to continue e Configure the SRCs and or liquid QC material under Setup and retry The analyzer is unable to calibrate the sample light gates due to dirty optics or cassette e Remove and discard the cassette Inspect and clean the optics glass and inside the sam
175. he battery voltage is low e Operate the analyzer on AC power and or recharge the battery 7 11 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 Diagnostics Not Ready 10 40 12 Nov Time and Date Diagnostics Setup Maintenance Q Up Za Home Fig 7 1 Diagnostics 7 2 1 Checking Versions ste m gt Diagnostics Not Ready 10 40 12 Nov Sensors ontro Tests 3 000020 2 00 0001 OPTIC2H 3 00 0020 2 00 0001 ure Top Plate 317 C Ambient 317 C Bottom Plate 317 C Gas Level Gas Pressure High 99 New LEDs Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 lon 1248 SMC Cover Close Miscellaneous Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V Q Up Home Fig 7 2 Versions 7 12 Your OPTI CCA TS has a number of useful diagnostic programs From the Ready display press System Manager Diagnostics Fig 7 1 The Diagnostics screen contains three tabs with various diagnostic functions Sensors Control and Tests From the Ready display press System Manager gt Diagnostics The first option on the Sensors screen Versions Fig 7 2 allows you to check the software version version of the optical module as well as the GUI version Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 2 Checking System Temperatures Syste m gt Diagnostics Not Ready 10 40 12 Nov Sensor
176. he unit will now delete all SRC data from the internal database 9 Press fj Home to return to the lt Ready gt display 4 7 4 CALIBRATION AND QUALITY CONTROL 4 5 3 Running a QC Sample Policies regarding the measurement of QC samples are at the discretion of the individual hospital OPTI Medical Systems recommends that QC solutions be run as a minimum with each new lot number of cassettes and at monthly intervals thereafter You should use only manufacturer recommended controls such as OPTI CHECK and OPTI CHECK PLUS which do NOT contain dye or other colored material Whenever a new lot of controls is opened be sure to enter the lot number information into the analyzer as described in Chapter 3 Customization NOTE Store controls at temperature recommended by the manufacturer NOTE The target value of PO2 is very sensitive to storage conditions and barometric pressure High altitude environments may see recovery outside the target range The control material should provide target values for all measured parameters over a range of measurement values typically seen in a laboratory The results obtained should fall within limits established by the user s laboratory 4 5 3 1 Running Controls OPTI CHECK OPTI CHECK PLUS Not Ready 10 40 12 Nov tHb Calibrator Qu Home Fig 4 13 Select Control 4 8 1 Inthe Ready display press lt QC Manager gt 2 Select lt Control gt
177. icable to the sensor cassette type being used for patient sample e The unit automatically checks the results against the ranges and stores the results in its internal database e For parameters within range lt Pass gt will be displayed and printed e For parameters out of range or if an internal drift is detected Fail will be displayed 8 Open the sample chamber cover and remove the SRC 9 Place the SRC back into its pouch immediately after removal from the instrument 10 Close the sample chamber cover e Ifthe SRC test failed gently clean the SRC the optics window and the inside cover of the SMC with alcohol and a lint free cloth and repeat this process If it fails again refer to the troubleshooting section of this manual e Perform the second SRC measurement with another SRC Level in the same manner If both SRC tests passed the unit is ready to perform measurements NOTE For application of QC Lockout please refer to section 3 3 3 1 2 NOTE Verify with your particular regulatory agency and your internal policy regarding number of levels and frequency of SRCs to be run A third level normal range of SRC is available as an option Part Number BP7554 Operator s Manual OPTI CCA TS 4 5 2 Printing SRC Results Ready 10 40 12 Nov Measurement Reports Statistics Controls Calibration Reports Patient SRC Controls Errors Miscellaneous Reports Configuration Maintenance Q Up
178. inienn ioa Und edu e cats 9 2 9 5 UU 001 o mmc 9 2 9 6 TT olt 9 2 97 Spare e E dM DIM DE a ene n EE UNE 9 3 9 8 Technical ASSIS CAC er M 9 3 9 9 Warranty Registration U S Market Only eeeeennn 9 4 ANALYTES d MEME EET pH 1 PH Dry Sensor EE pH B 1 CO ger ee ee ere ee ene eer E A eee eee Thee PCO2 1 PCO Dry Sensor B Lac Cassette iier erts S iniinis iniaiaiai issii PCO2 B 1 2 A reer PO2 1 PO Dry Sensor B Lag CGSB oues Dated ita eii tta odd d otto el aa asia Basset PO2 B 1 SEET Na 1 Potassium EQ e c M K 1 l nized Calcium a e Em Ca 1 Chloride GE T A CI 1 Glucose ELUCET Glu 1 BUN EIC BUN 1 Lactate B Lac Casse es M degen Lac 1 Total Hemoglobin Concentration ctHb and Fl mogiobin Oxygen Saturation SO 16 D THB SO2 1 SOFTWARE UPGRADES Use this section to store software upgrade instructions from OPTI Medical TECHNICAL BULLETINS Use this section to store technical bulletins from OPTI Medical Operator s Manual OPTI CCA TS V TABLE OF CONTENTS APPENDIX A TECHNICAL SPECIFICATIONS A 1 Meas rement Range M C A 1 Barometric TEE A 1 Opsrating Altitude Me CM PD A 1 Pollution B
179. instrument downtime is minimized Operator s Manual OPTI CCA TS 9 3 9 SUPPLIES 9 9 Warranty Registration U S Market Only After successful completion of the installation of your new OPTI CCA TS complete the enclosed Installation and Instrument Warranty Report form Return the completed form to OPTI Medical Systems Inc to ensure warranty support if you ever need warranty assistance The model and serial numbers of your OPTI CCA TS are on the bottom panel of the unit Please read the Instrument Warranty Terms and Conditions and become familiar with this agreement Each new analyzer purchased has a one year warranty from the date the analyzer is placed into service Contact the OPTI Medical Service Hotline for any assistance regarding warranty or support Operator s Manual OPTI CCA TS ANALYTES ANALYTES o pH 1 pH Dry Sensor BLacCGassettei sss nennen pH B 1 POO e PCO2 1 PCO Dry Sensor B Lac Casselle cias ie ria E aere Cep ire Aai PCO2 B 1 Loc PO2 1 PO Dry sensor B Lac Cassette rriaire MU PO2 B 1 Sodium Na e HU Na 1 POUASSILIN K5 Pe AEE K 1 POMOC Calcium A T aE Ca 1 Chloride GP pM METTE UT PEN Cl 1 Glucose EC siisii saiu eoiissoer aiina N TEEVEE EEEE EAEE O ENEAN AESi Glu 1 cH QS ore e eee BUN 1 La
180. intervals Ca 2 reference ranges A 5 references Ca 3 Gas valve reproducibility Ca 2 checking 7 16 iii ere A 8 pe EEN Glucose Glu vervoltage category A 6 Clinical significance Glu 1 L Oxygen conten ee Correlation to Other Methods calculation A 11 Glu 4 Lactate B Lac Cassette reference ranges A 5 Clinical significance Lac 1 Correlation to Other Methods Oxygen partial pressure PO2 Interferences Glu 2 s n clinical significance PO2 1 Linearity Glu 3 Measurement principle Glu 2 Measurement range Glu 2 Reference intervals Glu 2 Reproducibility Glu 3 SRC Limit Values Glu 2 H Hematocrit 8 9 calculation A 13 reference ranges A 5 Hemoglobin oxygen saturation 8 9 A 10 calculation A 10 reference ranges A 5 Hemoglobin oxygen saturation SO2 THB SO2 1 clinical significance THB SO2 1 measurement principle THB SO2 2 measurement range THB SO2 2 reference intervals THB SO2 2 Lac 4 Interferences Lac 2 Linearity Lac 3 Measurement principle Lac 1 Measurement range Lac 1 Reference intervals Lac 2 References Lac 4 Reproducibility Lac 3 SRC Limit Values Lac 1 Lactate setup 7 25 Language selecting 3 26 LEDs checking 7 14 Limitations 8 12 M Mains supply A 6 Maintenance 6 1 annual 6 7 correlation to other methods PO2 3 linearity PO2 3 measurement principle PO2 1 measurement range PO2 1 precision and recovery PO2 2 references PO2 3 reproducibility PO2 2 SRC limit values PO2 1 temperature corrected A 12 P
181. inting information in Chapter 4 Calibration and Quality Control and Chapter 5 Patient Testing Setting Time and Date 1 Inthe main menu press lt System Manager gt Fig 3 1 to access the lt System gt menu e Press lt Time and Date Fig 3 2 e Enter the password factory setting 404 when prompted to access the Time and Date screen Fig 3 3 Ready Sea X 10 40 22 Jul ISystem Time and Date Gas Not Ready 10 40 12 Nov Not Ready 10 40 12 Nov 83 Scan Cassette Barcode Time Format Baro 732 4 Ca Time and Date Diagnostics pan Time g Edit Date Edit gt Setup Maintenance Automatically Adust for Daylight Savings I Manual Entry Last Entry Daylight Savings Enable 8 Data QC System Manager Manager Manager Qane Bg Save Q Up Home Q Up Home Fig 3 1 Select System Manager Fig 3 2 Select Time and Date Fig 3 3 Time and Date i2hr 24hr c ei Operator s Manual OPTI CCA TS 3 1 3 CUSTOMIZATION iSystem gt Time and Date Not Ready 10 40 12 Nov Time Format d SC Time g Edit Date re Automatically Adjust for Daylight Savings T Daylight Savings Enable Li Qane H Save ev SC Fig 3 4 Time and Date 3 3 Setup Not Ready 10 40 12 Nov Time and Date Diagnostics me Maintenance d Qu Zen Fig 3 5 Setup 3 2 In the lt System gt Time and Date gt screen Fig 3 4 press vp o
182. l L 0 1 to 3 0 Tietz Norbert W Reference Intervals pp 2175 2217 Tietz Textbook of Clinical Chemistry 2nd Edition Philadelphia W B Saunders Co 1994 Henry JB Clinical Diagnosis and Management by Laboratory Methods 19th Edition Philadelphia W B Saunders Co 1996 Shapiro BA Peruzzi WT Kozelowski Templin R Clinical Application of Blood Gases 5th Ed Chicago Mosby 1994 Operator s Manual OPTI CCA TS A 5 APPENDIX A TECHNICAL SPECIFICATIONS Data Management Printout Built in thermoprinter Communication 1 x RS232C 1 x CF slot 1 x Ethernet port Format ASCII and ASTM Storage Data storage on the OPTI CCA TS is dynamic Typical storage capacity is gt 150 patient records QC data for 1 month at 3 levels SRC data for 1 month at 3 levels RS232C Pin Configuration ee6e0 J je eege V9 8 7 6 i REAR VIEW OF OPTI CCA TS Pin 1 No Connection Pin 2 RxD Pin 3 TxD Pin 4 DTR Pin 5 GND Pin 6 DSR Pin 7 No Connection Pin 8 CTS Pin 9 No Connection Mains Supply for External Power Supply 100 10 VAC to 240 10 VAC 50 60 Hz Overvoltage Category Category II when connected to a branch circuit A 6 Operator s Manual OPTI CCA TS APPENDIX A TECHNICAL SPECIFICATIONS Dimensions and Weight Height 4 7 12 0 cm Width 14 22 36 2 cm Depth 9 1 23 0 cm Weight w o Battery 10 Ibs 4 5 kg with Battery 12 lbs
183. le should be tightly capped refrigerated at 4 to 8 C for no longer than 48 hours and allowed to return to room temperature 15 to 30 C prior to analysis Each laboratory should determine the acceptability of its own blood collection syringes capillaries and tubes and the serum or plasma separation products Variations in these products exist between manufacturers and at times from lot to lot NOTE Serum is an unsuitable sample material for accurate glucose analysis because the retention time of the erythrocytes in the sample is too long The process of glycolysis may lead to decreased glucose values in serum samples Operator s Manual OPTI CCA TS 5 3 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 8 Test Conditions Sample Size a minimum of 125 uL 60uL for B60 cassette Sample Type heparinized whole blood serum plasma Sample Application syringe capillary or ComfortSampler Ambient Temperature 10 32 C 50 90 F Relative Humidity 5 to 95 non condensing Type of Measurement optical fluorescence pH PO PCO Na K Ca CT Glu BUN urea Lac and reflectance tHb SO 5 2 Sample Preparation 5 2 1 Whole Blood Samples Collect blood in a heparinized syringe a capillary tube or a ComfortSampler Whole blood samples should be analyzed as soon as possible ideally within 5 minutes after collecting the sample For brief storage of up to one hour the sample should be iced WARNING Whole blood
184. lected SO H 4009 H Q 1 Adult lgQ 2 9 1gPO 1 661 109 79 4 172 IgPO IgPO 0 48 pH 7 4 C 0 0013 BE Pm 25 7 Fetal leQ 2 9 1 g PO 1 363210 099 70 4 113 lgPO lgPO 0 48 pH 7 4 IS 0 0013 BE Po 21 5 l 8 Zander R Die korrekte Bestimmung des Base Excess BE mmol l im Blut Anesthesiol Intensivmed Notfallmed Schmerzther A 10 Operator s Manual OPTI CCA TS APPENDIX A TECHNICAL SPECIFICATIONS cto Oxygen content is the sum of oxygen bound to hemoglobin as O Hb and the amount of oxygen dissolved in the plasma This value is calculated from the measured O Hb and tHb if available and is estimated from the calculated SO if the measured O Hb is not available and if the calcula tion of oxygen saturation is selected If measured O Hb and tHb are available O Hb ctO 1 39 tHb 0 00314 PO 100 vol NOTE If PO is not available ctO is calculated with PO 90 mmHg If measured O Hb and tHb are not available and calculated SO is enabled SO tO 1 39 tHb 0 00314 PO 100 vol NOTE If PO is not available ctO is calculated with PO 90 mmHg P50 The oxygen partial pressure at half saturation P50 is defined as the PO value for a given blood sample at which 50 of the hemoglobin is saturated with oxygen While the actual P50 value can only be determined by interpolation after measurement of oxygen saturation of a bloo
185. lete Q Up Home Fig 7 56 Maintenance Log Maintenance Delete the Maintenance Log Fig 7 57 Delete Maintenance Log 7 32 This printout reports all settings such as QC ranges reference limits correlation factors patient information printout settings etc e To print a configuration report select Configuration in the Data screen Fig 7 55 e Press Up to return to the Data screen NOTE After initial setup a configuration report should be printed and kept in a safe place for later reference This printout reports all logged maintenance events e To print a maintenance log select Maintenance in the Data screen Fig 7 55 e Press Print to print the maintenance log Fig 7 56 e Press 2 D st to delete the maintenance database e Confirm your choice by pressing Yes in the Delete the Maintenance Log gt screen Fig 7 57 e Press Up lto return to the lt Data gt screen Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 3 Troubleshooting Procedure for tHb SO If your OPTI fails an Hb calibration or QC measurement for tHb or SO OPTI Medical recommends that you clean the SMC cover of your analyzer and then repeat the measurement The two small optical channels pictured below are re sponsible for the tHb and SO measurements These channels may get clogged or dirty causing the tHb and SO to fail calibration or OPTI Check contr
186. librator iO Qu Home Fig 4 1 Select SRC Enter Operator ID m 3 Enter your Operator ID or 4 digit PIN using the alphanumeric keypad Fig 4 2 SC E m T T T To bypass this function press OK 2 4 6 8 0 E i53 sr Eech rmt frs Ea dee al a eS NOTE If Operator ID is configured as required in Setup you cannot go to the next step A p 1i L unless a valid Op ID is entered s el nl aiel l l NOTE If Secure Op IDs is activated under Setup Exe you will be prompted for your 4 digit PIN ie instead of your Op ID Cancel Ok Fig 4 2 Enter Operator ID NOTE Bar coded Operator IDs may be entered using the bar code scanner Not Ready 10 40 12 Nov Open Cover Em r a 4 Open the sample chamber cover by pressing the button Fig 4 3 Cancel 9 erm Fig 4 3 Open Cover 4 4 Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL Not Ready 10 40 12 Nov Insert SRC 5 Examine the SRC to ensure it is clean and insert it into the chamber Press down to properly seat the SRC Fig 4 4 Cancel ole Fig 4 4 Insert SRC Not Ready 10 40 12 Nov Close Cover 6 Close the sample chamber cover Fig 4 5 Cancel ole Fig 4 5 Close Cover After the cover has been closed the instrument will SRC HOT automatically detect which level of SRC has been rmation Correct S Lot XXXXXX Level X inserted
187. lished procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n OPTIR 0 99 4 15 0 984 3 53 21 184 146 Analyzer A 0 94 1 88 0 982 1 62 22 7 93 2 112 For more information on specific analyzers used please contact OPTI Medical Technical Support OPTI CCA TS with B Lac Cassette vs other PCO Instruments on whole blood in house testing Whole blood samples from multiple donors were tonometered with different CO gas mixtures to generate a wide range of PCO values The blood samples were analyzed in parallel on the B Lac cassette and other laboratory instruments Correlation Comparative Method Slope Intercept Coefficient Sy x Range n OPTI CCA std PCO sensor 1 00 2 12 0 994 3 52 13 196 162 Analyzer B 0 96 1 75 0 986 3 34 13 104 153 Analyzer C 1 01 0 47 0 994 3 74 15 199 162 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b PCO2 B 4 Operator s Manual OPTI CCA TS ANALYTES PO 2 PO 2 Clinical Significance The PO value of arterial blood is used to assess how well the body is able to absorb oxygen in the lungs Values below the normal arterial P
188. m Potassium isr Correlation Slope Intercept Coefficient Sy x Range n Potassium 0 9964 0 116 0 99893 0 14 1 0 9 0 30 Potassium 0 9723 0 135 0 99956 0 05 2 0 6 0 18 NIST Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 1 0816 0 138 0 9857 0 13 2 1 6 4 103 Analyzer B whole blood 1 0225 0 008 0 9673 0 15 2 4 6 0 173 Analyzer C whole blood 1 021 x 0 019 0 087 0 077 0 9830 0 197 2 3 94 105 Analyzer D whole blood 1 050 0 126 0 062 0 055 0 9879 0 055 2 2 9 4 174 Analzyer E serum 1 084 0 315 0 9855 0 181 2 9 7 5 68 Analyzer F serum 1 126 0 397 0 9784 0 108 3 0 5 4 102 YS wm For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with
189. mber of controls is not run patient measurements will not be allowed 8hr Requires controls to be run every 8 hours lt 12hr gt Requires controls to be run every 12 hours lt 24hr gt Requires controls to be run every 24 hours 7dy Requires controls to be run every 7 days 3 17 3 CUSTOMIZATION 3 18 1 Select the desired option 2 Press N ae to accept the changes Oe 3 Press Cl to return to the lt Setup gt screen or Home to return to lt Ready gt NOTE NOTE More than one option can be selected For instance laboratories can require that a combination of SRCs and liquid OC is run on a daily basis This should be based on hospital policy The system default is OC lockout disabled Control lockouts are based on data stored in the Controls database see Section 4 This database may include data measured with any cassette lot or cassette type Patient measurements will not be allowed unless all analytes on that cassette have satisfied the lockout requirements for number of control levels and required time period Option 3 New Lot Lockout Enable Controls must be run with every new lot of cassettes At least one level must have passed within the previous 60 days If this is not done the system will not allow patient samples to be run NOTE More than one option can be selected For instance laboratories can require that a combination of SRCs and controls are run on a d
190. ments sss eene eene nnne nnne n nnne nnne 8 3 8 4 3 Anticoagulants and Sample Collection Devices eeeccesseeeeeeeeeeens 8 3 844 Synge RERO n 8 3 8 4 5 Capillary IUc cem 8 3 8 4 6 OPTI Medical ComfortSamplers ccccceccceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 8 4 8 4 7 Handling and Storage E ale 8 4 OM Qo p mr DC Sedna 8 5 E NEE EE e DE 8 5 8 5 2 Test e eine ue E 8 6 8 5 3 Input Values 0 eee eee a Ena Kaa ara AEA TEn nnnm nnnm nnne een rennen nennen eren nennen nens 8 6 8 5 4 Calculated Values ENEE 8 9 8 3 9 mes Or 19 1119 DE 8 9 B E CODIPOL dot asa ssrceereniconstuiresecunnslenstetucsfcienerieceniememheetenemes draenei Ea UU 8 10 8 5 7 Reference Intervals ssssssssssssssssssssssssssesseeeeeee nennen rrr rrr EEEE EEEE 8 11 8 5 8 Specific Performance Characherisice eene 8 11 8 9 9 IMITATIONS E Ter M E 8 12 Lan En e 8 13 8 5 11 Accessories 0 cece cece cece cece cee cee eeeseee eee eae seaaeaaaeeaessaaesseessaeeseeeeeeeeeeeeeeeneeseeeeseeeeeeeseeseeeees 8 14 Operator s Manual OPTI CCA TS 8 i 8 OPERATING PRINCIPLES 8 OPERATING PRINCIPLES 8 1 Intended Use The OPTI CCA TS Critical Care Analyzer is intended to be used for the measurement of hydrogen ion concentration pH carbon dioxide partial pressure PCO oxygen partial pressure PO sodium Na potassium K ionized calci
191. mmol L 1 0 200 0 mmol L 1 0 200 0 mmol L 6 500 8 000 0 0 100 096 0 0 56 0 mL dL 15 7596 10 0 1000 0 nmol L 0 0 800 0 mmHg 3 30 15 0 mmol L 35 0 mmHg 0 1 3 0 mmol L Parameter Range Display Units Resolution Lo Hi pH 6 6 7 8 0 01 0 001 pH units PCO 10 200 1 0 1 mmHg PO 10 700 1 0 1 mmHg Operator s Manual OPTI CCA TS Reference Ranges APPENDIX A TECHNICAL SPECIFICATIONS Parameter Units Range Reference Source Actual bicarbonate HCO3 mmol L 18 to 23 Tietz page 2179 Base excess BE mmol L 2 to 3 Tietz page 2179 Base excess ecf BE mmol L 2 to 3 Tietz page 2179 Base excess actual BE mmol L 2 to 3 Tietz page 2179 Buffer bases BB mmol L 46 to 52 Henry page 152 Total CO tCO mmol L 22 to 29 Tietz page 2181 Standard bicarbonate st HCO mmol L 22 to 24 Shapiro page 175 Standard pH st pH pH units 7 35 to 7 45 Tietz page 2201 Oxygen saturation LC ch 95 0 to 98 0 Henry page 1453 Oxygen content O ct vol 15 0 to 23 0 Tietz page 2200 Hematocrit Hct c 34 to 51 Tietz page 2192 Hydrogen ion concentration cH nmol L 36 to 44 Tietz page 2201 Alveolar arterial oxygen partial mmHg 5 to 20 Henri page 157 pressure difference AaDO Anion Gap AG mmol L 10 to 20 Tietz page 2178 P50 mmHg 25 to 29 Tietz page 1392 Normalized ionized calcium nCa mmo
192. nalyzer B whole blood ctHb 0 9866 0 14 0 9715 0 37 6 9 14 8 173 SO2 0 7972 18 80 0 9064 1 81 64 100 173 Analyzer C whole blood ctHb 1 077 0 020 0 284 0 227 0 9650 0 739 54 174 215 SO2 1 021 0 016 2 920 1 522 0 9752 1 470 62 100 215 For more information on specific analyzers used please contact OPTI Medical Technical Support References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 3 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 p 1004 4 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b 5 NCCLS Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Approved Standard 3 Edition NCCLS document H15 A3 NCCLS Wayne PA 2000 THB SO2 4 Operator s Manual OPTI CCA TS APPENDICES APPENDIX A TECHNICAL SPECIFICATIONS A 1 Measurement E e uo edic quqnquiaB aarti arcurs eaten guns o cada OR CEU Grae Aa EURO DUM ORG A 1 Barometric Pressure A 1 ru pte A 1 Pollution Degree m
193. nemic Hypoxia Hypoxia due to lowered oxygen carrying capacity of the blood this may be either from a decrease in total hemoglobin or a change in components of the hemoglobin e Stagnant Hypoxia A type seen when not enough oxygen is transported by the blood because blood flow is reduced such as with heart failure e Histotoxic Hypoxia Hypoxia that is due to impaired use of oxygen by tissues e Hypoxic Hypoxia Hypoxia that is due to insufficient oxygen reaching the blood e Ischemic Hypoxia Hypoxia that occurs when blood flow to tissue is low Measurement Principle The OPTI Medical lactate biosensor contains the enzyme lactate oxidase to selectively catalyze the reaction between lactate and oxygen as outlined in the reaction sequence L Lactate O Lactate Oxidase Pyruvate H O The oxygen consumption is measured photochemically by an optical sensor The rate of oxygen consumption is proportional to the concentration of lactate in the specimen Measurement Range Range Resolution Low High Units 0 3 17 5 0 01 0 01 mmol L 2 7 157 7 0 1 0 1 mg dL Operator s Manual OPTI CCA TS Lac 1 LACTATE ANALYTES Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 1 00 0 30 2 50 0 50 5 00 0 50 mmol L 9 0 2 7 22 5445 45 0 9 0 mg dL Interferences The Lactate sensor response in whole blood is affected by the amount of hemoglobin present in the sample The algorithm us
194. nformation Measured Parameters Calculated Patient Entry Parameters Normal Ranges Correlation Units Alarm Limits Q Up Home Fig 3 6 Select SRC Fig 3 7 Scan Bar code ISystem Setup SRC Not Ready 10 40 12 Nov 1 2 3 Level Cc D C Lot Number Gea Expiration AER Qoi H Save Q Up Home Fig 3 8 Confirm SRC Information Operator s Manual OPTI CCA TS When you open a new SRC the lot number should be entered into the analyzer along with the expiration date Each SRC level of control has its own unique lot number printed on the pouch NOTE The procedure for programming SRC QC ranges as described below is identical for all levels 1 From the Ready display select System Manager and Setup 2 Enter the password if this security function has been activated under Setup 3 In the System Setup menu press lt SRC gt Fig 3 6 4 Take an SRC pouch and scan the bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer Fig 3 7 e The red line from the bar code scanner should cover the entire bar code e Abeep indicates a valid bar code e Ared status light indicates an invalid bar code e g SRC expired NOTE If the bar code is damaged or unreadable enter the bar code digits using the keypad 5 Ifthe level lot number and expiration date are correct press f
195. nostic use For professional use only Bibliography 1 Guilbault GG Ed Practical Fluorescence 2nd Edition Marcel Dekker 1990 2 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 3 Mahoney JJ Wong RJ Van Kessel AL Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 79 1993 4 J B Henry Clinical Diagnosis and Management by Laboratory Methods 19th Ed 1996 p 590 777 5 Clinical and Laboratory Standards Institute CLSI nterference Testing in Clinical Chemistry Approved Guideline 2nd Edition CLSI document EP7 A2 CLSI Wayne PA 2005 Operator s Manual OPTI CCA TS 8 15 9 SUPPLIES MES a i zc eee 9 1 9 1 Analyzer tmm 9 1 PME Coo E 9 1 9 3 Controls CalibratOrS sssrisissiissiiniinrii sincan reana DS ER RexRE aane ananisaidia 9 1 94 Consumable ltemS ssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn nnmnnn nnnnn nennum nnmnnn 9 2 CEET 9 2 96 Dii pec 9 2 9 7 Spare oo Mc 9 3 9 8 Technical c E 9 3 9 9 Warranty Registration U S Market Only eene 9 4 Operator s Manual OPTI CCA TS 9 i 9 SUPPLIES 9 SUPPLIES Each OPTI CCA TS is shipped with maintenance supplies and other accessories
196. not receive a results screen or printout until the setup procedure is complete Continue to run the OPTI check with the same lot of cassettes and OPTI check until prompted You may run from 5 to 8 OPTI checks Completed 2 of 8 OK Cancel Fig 7 39 Run Controls iSystem gt Diagnostics gt Lactate Setup e After running the required number of samples the lactate parameter is enabled Fig 7 40 Run new Level 2 Control Using a new vial Lactate Setup Prooees Conia You will receive a lactate setup report once Lactate is enabled complete 5 Completed 2 of 8 OK Cancel Fig 7 40 Lactate enabled e Press OK to exit the menu After completing this procedure OPTI Medical recommends that you run two levels of OPTI Check using B Lac cassettes to verify performance 7 26 Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 21 Checking the Ethernet Interface Syste m gt Diagnostics Not Ready 10 40 12 Nov The purpose of this test is to check for proper functioning of the Ethernet interface Sensors Control Tests From the lt Ready gt display press lt System a gies os Manager gt lt Diagnostics gt RS232 Flow Pump e Select the lt Tests gt tab e Press Ethernet to start the test Fig 7 41 Display Touch Gas Test Lactate Setup Q Up Home Fig 7 41 Ethernet System gt Diagnostics gt Ethernet Not Ready 10 40 12 Nov Connec
197. ntified with this symbol can be considered recyclable This symbol is located on all applicable product packaging WEEE Symbol This product complies with WEEE Directive 2002 96 EC which mandates the treatment recovery and recycling of electric and electronic equipment Symbol Cc REF il aol Explanation Biohazard Symbol Products and or components containing this symbol should be handled as biohazardous material after use Temperature Limit Symbol Products and or components which contain this symbol must be stored within the specified temperature range For in vitro diagnostic use This product fulfils the requirements of Directive 98 79 EC on in vitro diagnostic medical devices Catalog number Please read pack insert Follow the instrument s instructions for use Manufactured by Authorized European Community Representative PREFACE PREFACE Welcome Your OPTI CCA TS Analyzer is a powerful tool designed to help you quickly accurately and efficiently conduct basic testing of hydrogen ion concentration pH carbon dioxide partial pressure PCO oxygen partial pressure PO sodium Na potassium K ionized calcium Ca chloride CF glucose Glu blood urea nitrogen BUN lactate Lac total hemoglobin concentration tHb and hemoglobin oxygen saturation SO depending on the cassette configuration in the convenience of your own laboratory This manual will help guide you through s
198. nto standby mode which turns off the sample measurement chamber heaters to conserve the battery Battery save mode has the following options Off The system will always stay on in the Ready mode until the operator turns the system off 10 Min The system will go to standby mode after 10 minutes of inactivity 60 Min The system will go to standby mode after 60 minutes of inactivity 4 Press M to accept the changes 5 Press C ii m return to the Setup screen Or f none to return to Ready Operator s Manual OPTI CCA TS 3 3 3 5 Setting Up Communications 3 3 3 5 1 Configuring the Communication Format ISystem Setup Hardware Not Ready 3 310 40 12 Nov Settings Interface hernet External Barcode Enable r Communication ASCII ASTM CF Format c c c Link Serial Ethemet c D Compact Flash Comma Semicolon Delimiter c c Qoo Defaults H sae ve Py Home Fig 3 39 Interface iSystem gt Setup gt Hardware Not Ready 10 40 No Settings Intertdke__Ethernet gt E1394 Format e IP Type Deme Static e c IP Address 0000 Best Subnet Mask 2552552550 dieat UDP Port e d4t eege geat Qoi Defaults fa Save ve Fy Home Fig 3 40 Ethernet Settings TCP Port Host IP Operator s Manual OPTI CCA TS 3 CUSTOMIZATION Your OPTI CCA TS has an RS232 standard serial interface with a baud rate fixed at 9600 and an Ethernet
199. ntrol program and has become an integral part of a complete laboratory Quality Assurance program The analysis of unknown samples demonstrates that your results are unbiased by previous experience and these samples more closely reflect the testing of patient samples Proficiency testing may also serve to expand your Quality Control testing by providing samples with different levels of analytes than those measured in the daily testing program The relative testing performance of each laboratory participating in the proficiency survey is determined by comparing test results obtained from a significantly large group of laboratories using the same or similar instrumentation CAUTION Use proficiency material that is clear Do not use material that contains dyes or emulsions The Joint Commission on Accreditation of Healthcare Organizations JCAHO has published a protocol for establishing a quality assurance program The Health Care Financing Administration HCFA and the Clinical and Laboratory Standards Institute CLSI formerly NCCLS have published standards for quality assurance in medical laboratories Calibration Verification Calibration verification allows for the validation of the blood gas analyzer s ability to recover known values at various points within the reportable range of all parameters and may be required by various regulatory agencies The OPTI CCA TS Analyte Section included in the back section of this manual provides precisi
200. o A 1 Operating Parameters ee ee i ueste in od brit ee dai sce etude eu e EudE A 2 Dea crm A 2 Temperature Corrected Values eee A 4 Reference RANGES E A 5 D ta IW crocum E A 6 RS2320 Pin COMMU el lOi EE A 6 Mains Supply for External Power Supply ecceeceeecceeeeeeeaeeeeaeeaaecaaeeaaeeaeceaeeeaeeeaeeeaeenaeeeas A 6 Overvoliage Category c A 6 Dimensionsand WY SI e EUER A 7 Ee e EEN A 7 Calculated Parameter A 7 Temperature cocus px xxx a x GR ER EE E E uy sau E E ERG GE D ER RR DR A e A 7 Units Used in Measured and Input Parameters for Calculatons A 8 Conversion Table for Units 5 0 eroi ierra eade cp GR a er e za e E a e AE dn cuv LG A 8 APPENDIX B MENU STRUCTUNE eracucccocc uoo aree seu egener B 1 APPENDIX C MAINTENANCE LOG eeeeeeeeeeeeeeene nnn C 1 APPENDIX D REPORT FORMATS conne rect eerie D 1 Basic Patient FOpOELU Seeerei t ES el een dataset eG todas Ee D 1 SRC Measurement Report ceeds eos retento p d nit o n v d c n d a n n t D 2 SRC Statistics Report D 3 Controls Measurement Report ssssssssssssssssssssssssseeeeee nennen een nee nennen n nne n nnne nennen D 4 Controls Statistics I6 DOTT 27 0 ertet a o ded Roe do eei ver ae e o usa doe va uo rex c eee Eu vod RE HUP daa dh D 5 Contigu ration Report Part1 E D 6 Configuration E ag e
201. oduction method Sufficient volume must however be present in syringes 0 25 mL ina mL syringe to prevent mechanical interference between the syringe plunger and the syringe adapter Errors in blood analysis on properly collected samples may result from improper mixing of the sample after collection and before measurement contamination with room air resulting from failure to expel any trapped bubbles after collection and from metabolic changes in the sample Serum samples should be obtained by collecting blood in an untreated blood collecting tube The sample should stand for 30 minutes to allow the clot to form prior to centrifugation After centrifugation remove the serum from the clot and cap or seal the sample tube If storage is required the sample should be tightly capped refrigerated at 4 to 8 C for no longer than 48 hours and allowed to return to room temperature 15 to 30 C prior to analysis Each laboratory should determine the acceptability of its own blood collection syringes capillaries and tubes and the serum or plasma separation products Variations in these products exist between manufacturers and at times from lot to lot NOTE Serum is an unsuitable sample material for accurate glucose analysis because the retention time of the erythrocytes in the sample is too long The process of glycolysis may lead to decreased glucose values in serum samples 8 5 Procedure 8 5 1 Materials Needed Description Part Number
202. ol L Operator s Manual OPTI CCA TS Ca 1 CALCIUM ANALYTES Interferences The OPTI CCA TS Ca sensor does exhibit an interference from bisulfate and phenylacetic acid Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogenous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount Ca change mmol L Sodium fluorescein 26 mg dL unstable Cardio indocyanine green 0 5 mg dL 0 01 Methylene blue 25 mg dL unstable Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments Ionized calcium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 1 26 0 001 0 1 0 007 0 6 0 007 0 6 Level 2 1 16 0 002 0 2 0 010 0 9 0 011 0 9 Level 3 0 79 0 001 0 1
203. ols The simple cleaning procedure below can be used for OPTI CCA OPTI CCA TS or OPTI R analyzers and may correct tHb and SO failures 1 Open the SMC cover and locate the two small optical channels pictured below Fig 7 58 Fig 7 58 Locate Optical Channels 2 Clean the optical channels using a cotton swab or lint free cloth dipped in alcohol or ammonia based cleaner Fig 7 59 Fig 7 59 Clean Optical Channels Please contact OPTI Medical at 1 770 510 4444 or 800 490 OPTI 6784 or technicalsupport optimedical com for any additional questions or information regarding this procedure Operator s Manual OPTI CCA TS 7 33 7 DIAGNOSTICS AND TROUBLESHOOTING 7 4 Troubleshooting Procedure for Bar Code Scanner If you experience difficulty scanning bar codes clean the bar code scanner window with alcohol and a lint free cloth If difficulty continues check the bar code scanner window for scratches Call OPTI Medical Technical Support for a replacement bar code scanner window 7 34 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES 8 OPERATING PRINCIPLES cccscsscetsccccesescececsiscccsrascctsbenccescesdecsusseeeceessete 8 1 uM e oi lee in ns 8 1 02 Principles of PIOCBOUFG Leia gege 8 1 A AES T E 8 2 8 4 Specimen Collection and Handling ecce 8 3 AME ee e aAa 8 3 8 4 Sample Require
204. on This chapter describes OPTI CCA TS specific error messages and recommends steps that should return your OPTI CCA TS to operation If your OPTI CCA TS does not perform correctly after conducting the basic steps outlined in this chapter you should contact OPTI Medical Systems for technical assistance 7 1 Error Displays The sensors did not see any sample Make sure sample is properly attached and not clotted and does not contain air bubbles Wait for the system to recalibrate WARNING No Sample Detected e Remix sample carefully OK e Press OK to notify the system that the sample is reattached and reaspirate sample The displayed measured parameter is unstable WARNING Unstable pH Qu TN NOTE This message is a warning The analyzer will however display a result for the parameter Se concerned e Remove cassette and check for aspirated bubbles e Ifbubbles are present over a sensor do not report that parameter E The displayed sensor is bad WARNING Bad Sensor pH e You have the option of continuing the measurement by pressing OK or stopping by pressing Canet If you continue no results will be provided for the bad sensor or any calculated result which utilizes this measurement in its calculation OK Cancel Operator s Manual OPTI CCA TS 7 1 7 DIAGNOSTICS AND TROUBLESHOOTING WARNING Low Battery 1 Test Remaining S WARNING Gas Expires soon 5
205. on and recovery data for all the measured parameters in the ranges that are usually encountered in the diagnostic testing of patients A calibration verification kit is available from OPTI Medical for all parameters except tHb and SO For calibration verification of tHb and SO OPTI Medical recommends testing whole blood against a reference analyzer Operator s Manual OPTI CCA TS 4 5 4 CALIBRATION AND QUALITY CONTROL Should a laboratory wish to perform a calibration verification for measurement values outside the broad range OPTI Medical Systems suggests tonometry of whole blood for PO and PCO correlation against flame photometry for electrolytes correlation against cyanmethemoglobin method for tHb and blood pH correlation with conventional blood gas analyzers For calibration verification of glucose OPTI Medical Systems recommends the hexokinase procedure as proposed by the FDA Federal Register 39 No 126 24136 24147 In the case of BUN urea OPTI Medical Systems recommends correlation against the end point coupled enzyme method described by Sampson and Baird et al in Clinical Chemistry 26 816 826 1980 QC Recommendations Two standard Reference Cassettes SRC should be used as a control for the OPTI CCA TS analyzer The level 1 and level 3 SRCs represent high and low samples The SRCs contain a stable optical sensor simulator which is measured by the device in exactly the same manner as any other cassette and
206. ons are partially absorbed and reflected by erythrocytes in a manner proportional to hemoglobin level at low hemoglobin levels the unabsorbed photons strike the O optode s pink overcoat and are reflected back up through the blood a second time A portion of the reflected light exits the top of the cassette and is measured by a detector in the instrument The infrared wavelengths are selected for the hemoglobin measurement because they are largely independent of SO that is the predominate forms of adult and fetal hemoglobin absorb similarly within the 750 850 nm wavelength range The red wavelength is utilized for the SO measurement because it is much more strongly absorbed by deoxyhemoglobin than all other hemoglobins and it is picked close to the isosbestic point for oxy and carboxyhemoglobin Sensitivity to erythrocyte aggregation rouleaux formation is minimized by maintaining high shear force just prior to measurement see Interferences below Measurement Range Range Resolution Low High Units tHb 5 to 25 0 1 g dL SO2 60 to 100 1 0 1 Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units tHb 20 0 1 5 14 0 1 5 8 04 1 5 g dL SO 70 0 2 90 0 2 98 0 2 Interferences The following interferents were quantified in whole blood showing sensitivity to dyes similar to most CO oximeters Substance amount ctHb change g dL SO change EXOGENOUS Cardio Indocyanine Green 0 5 mg dL
207. ontrols Info Oper ID ON Opt Lev 1 LimMin LimMax AccNum ON Opt pH 7 120 7 240 DOB oN PCO2 60 0 76 0 mmHg remp DH PO2 62 0 86 0 mmHg Sex ON Na 121 0 131 0 mmol l Hb Type ON K 2 60 3 40 mmol l Sampre Types ON Cl 84 0 94 0 mmol l itg ON Ca 1 44 1 74 mmol cHe ja Glu 30 0 400 0 mg dL Oe Mode 2 BUN 2 8 112 0 mg dL FIOS ON Lac 0 70 1 10 mmol I a Es tHb 18 2 22 2 g dL E SO2 76 0 82 0 MERE Mene ON QCLot 9169 Exp Mar2012 IVol ON Lev 2 LimMin LimMax s em pH 7 360 7 480 S lat ON PCO2 37 0 45 0 mmHg E PO2 90 0 114 0 mmHg DN Na 137 0 151 0 mmol L pues n K 4 40 5 20 mmol L i Cl 102 0 112 0 mmol L Rare ob Ca 1 14 1 34 mmol L Tarer Plow ON Glu 30 0 400 0 mg dL I E Ratio ON BUN 2 8 112 0 mg dL EE D Lac 1 90 3 30 mmol L Hae ees DN tHb 12 8 15 8 g dL User Def 2 DN SO2 87 0 93 0 amp xdi IE TM OCLot 9269 Exp Mar2012 gt W Lev 3 LimMin LimMax Bypass dius pH 7 580 7 680 Def tHb 15 0 g dL BOUE 20 099720 amio Petes E PO2 131 0 155 0 mmHg Def DIE 0 21 Nat 151 0 165 0 mmol L Det RO 0 84 K 5 30 6 30 mmol L Def P50 26 7 mmHg Cl 118 0 128 0 mmol L D 6 Ca 0 66 0 90 mmol L Glu 30 0 400 0 mg dL BUN 2 8 112 0 mg dL Lac 3 60 5 40 mmol L tHb 8 1 11 1 g dL SO2 94 0 99 0 QCLot 9369 Exp Mar2012 Printouts Patient ON copies 1 Calib OFF Ref Rng ON Dest Both Connect Ethernet IP Port 9100 IP Addr 192 16
208. operly identify the specimen following usual procedures for such documentation Place the syringe containing the specimen in an ice slurry Blood gases and pH content will change if the specimen remains at room temperature in a syringe for more than 5 minutes due to cellular metabolism PO changes due to oxygen consumption may be influenced by several factors including white blood cell count reticulocyte count storage temperature and initial PO value At storage temperatures of 1 to 5 C the results obtained from the specimen are valid up to 2 hours Samples expected to have high white blood cell count reticulocyte count or high PO values should be analyzed as soon as possible after collection 8 4 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES Erythrocyte aggregation and sedimentaton may occur very quickly in syringes containing pathologic blood samples and may adversely affect the measurement of ctHb in any analyzer To prevent such errors first insert the OPTI CCA TS cassette into the analyzer to initiate calibration Next mix the syringe sample well by rolling the syringe for at least 60 seconds after expelling any trapped bubbles then immediately measure in the OPTI CCA TS The OPTI CCA TS system aspirates blood in the same manner from syringes capillaries or ComfortSampler No changes are made to the aspiration rate volume or timing Therefore there are no biases or imprecision dependent upon the sample intr
209. or ComfortSampler attach the sample to the cassette fillport Fig 5 9 and Fig 5 10 and press OK 5 7 5 SAMPLE HANDLING AND PATIENT TESTING E e When using a syringe make sure the red syringe adapter is not touching the syringe EA plunger lt q WARNING Do not inject the sample It will be automatically aspirated Fig 5 10 Attach Syringe Sample Measurement Measuring 10 40 12 Nov Gas 83 7324 Sample Aspiration in gin mag e The sample will then be aspirated Fig 5 11 Fig 5 11 Sample Aspiration IMeasur t aT HOO T 412 Nov e Next the sample is measured During the Gas measurement the status light is blinking and Sei a progress bar is displayed Fig 5 12 rea Cassette Measurement In Progress Please Wait Do not open the cover of the sample measurement chamber during the measurement If you do the cassette and the sample must be discarded Measuring Leg es 8 To enter patient information while measurement is in progress press lt Patient Info gt Fig 5 12 SEH Patient Info Fig 5 12 Sample Measurement 5 8 Operator s Manual OPTI CCA TS Measurement Edit Patient Data or Press Home for Ready apy panon Patient info el cl LQ gc Fig 5 13 Edit Patient Data iMeasurement gt Patient Data Measuring 10 40 12 Nov Operator ID Edt Patient ID Edt DOB Edt Accession Edt Temperature Edt Sex Back Page 1 of 7 Next ren Zo Home
210. or ID function to limit access to analyzer to properly trained authorized users See section 3 3 3 1 3 e From the Ready display select System Manager and Setup e Inthe System Setup menu press the Miscellaneous tab and select Security Fig 3 31 The OPTI CCA TS has a password function which when activated will deny access to the setup menus and certain database functions The correct password will have to be entered to grant access to these menus and functions The password is especially useful to ensure that only authorized operators can alter customized settings The factory default password is 404 The factory set password can be changed to any number between 0 and 9999 up to 4 digits 1 Select Password Enable in the Security menu Fig 3 32 You will then be able to enter a number 1 4 digits in the Setup PW gt field 2 Press Edit to enter the numbers and press fel Save to accept the changes CAUTION Make sure the password is kept confidential and in a safe place Passwords can not be retrieved 3 Press Q Up lto return to the lt Setup gt screen or Home to return to lt Ready gt Operator s Manual OPTI CCA TS 3 3 3 1 2 Selecting QC Lockout Syste m gt Setup gt Security p SRC Locko Number of 1 3 SRC Levels C Cc C Shr 12hr 24hr 7dy Time Interval x K is Control Lockout Enable LI Number of 1 2 3 QC Levels c c c Bhr 12hr 24h 7
211. ottle in place the pressure should be approx 9995 with the bottle removed the pressure should be 00 From the Ready display press System Manager and Diagnostics To install a new gas bottle press New Scan the bar code located on the side of the gas bottle to install a new gas bottle see Section 6 5 1 Changing Gas Bottle Press Cancel to initiate a gas purge or press to cancel this function and return to the Diagnostics screen 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 4 Checking the LEDs Syste m gt Diagnostics com The purpose of this test is to check proper Sensors cows fg functioning of the LEDs This test should be Versions performed only by trained service personnel OPTICCA 3 00 0020 2 00 0001 ics TI En 3000020 2000001 From the lt Ready gt display press lt System WT MI C Ambient 317 Manager gt Diagnostics Bottom Plate 317 C Gas Level The following information is displayed in the LEDs section Fig 7 5 Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 on 1248 SMC Cover Close Miscellaneou e Front Rear lon fluid light gates Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V e n e Cassette Misseat gt detector located in Qv Gd cover Fig 7 5 LEDs e Cassette Detect gt sensor e SMC Cover this test function indicates whether the SMC cover is closed or open
212. ow provides important information regarding supported sample types available reporting units and analyzer measurement ranges for each parameter Sample Type Available Units Measurement Display Range Resolution Parameter Whole Plasma Serum Default Other Default Units Lo Hi blood pH X X X pH units 6 6 7 8 0 01 0 001 PCO D mmHg kPa 10 200 1 0 1 PO D mmHg kPa 10 700 1 0 1 Na X X X mmol L mg dL 100 180 1 0 1 K x x x mmol L mg dL 0 8 9 99 0 1 0 01 Ca x x x mmol L mg dL 0 2 3 0 0 01 Cr x x X mmol L mg dL 50 160 1 0 1 Glu D D D mg dL mmol L 30 400 1 7 22 1 0 1 BUN urea X X X mg dL mmol L 2 8 112 0 1 40 0 1 0 01 Lac x mmol L mg dL 0 3 17 5 0 01 0 01 tHb D g dL mmol L g L 5 25 0 1 SO D K 60 100 1 0 1 Principles of Operation The OPTI CCA TS is a microprocessor controlled medical instrument measuring optical fluorescence from discrete sensors called optical electrodes optodes A disposable single use cassette contains all of the elements needed for calibration sample measurement and waste containment Specific calibration information from the cassette is scanned into the analyzer by holding the cassette package in front of the bar code scanner The cassette is then placed into the measurement chamber The analyzer warms the cassette to 37 0 0 1 C 98 6 0 1 F and performs a calibration verification on the sensors for PCO and
213. ple measurement chamber top cover e Press OK m continue e Check the LEDs See Section 7 2 4 The Operator ID already exists in the database e Press OK re continue e Enter a unique Operator ID The PIN number does not exist in current Secure Op ID database e Press OK to continue e Retry with a valid PIN number The PIN number already exists in database e Press OK to continue e Enter a unique PIN number Operator s Manual OPTI CCA TS RK ERROR No Response Retry E ERROR Host not Ready Retry ERROR Calibration Out of Range 7 STOP Low Battery Recharge Now OK STOP Low Battery Recharge and Cycle Power 2 Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The OPTI CCA TS received no response from the host computer e Press Yes to retry If the problem persists e Check connection between the OPTI CCA TS and the host computer e Check the OPTI CCA TS s communication configuration under System Hardware e Check the host computer The OPTI CCA TS received a negative NAK response from the host computer e Press Yes to retry If the problem persists e Check the host computer or contact the facility IT manager This error may occur during Hb calibration The error is triggered when the correction is greater than 1096 To retry e Replace the Hb calibrator e Perform a Last Blood
214. ple handling documentation and specific procedures used approved by the personnel responsible 8 4 3 Anticoagulants and Sample Collection Devices Lithium heparin is the only acceptable anticoagulant for blood gas and electrolyte analysis Lithium heparin sodium heparin or balanced heparin salts are the only acceptable anticoagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and should not be used Lithium heparin should not be used for samples taken also for analysis of lithium 8 4 4 Syringes If liquid heparin is used as an anticoagulant collection devices should be no larger than the amount of blood required to minimize the effects of dilution of the blood by the anticoagulant solution Although plastic syringes are commonly used for collection of blood specimens for blood gas analysis there have been reports in literature regarding the use of plastic syringes when PO values higher than normal are expected Particular attention should be paid to cooling blood samples in ice water because of the CO and oxygen solubility in some plastics If blood specimens are expected to have very high PO values care should be taken to analyze the specimen as quickly as possible following collection to avoid the need for cooling Attention should be paid to thorough mixing of whole blood samples prior to analysis since sedimentation of blood cells aff
215. provides assurance that all measured parameters by the analyzer are consistent The results obtained should fall within limits contained in the SRC barcode NOTE Hospitals should develop their own policy and procedures on the number of QC samples to be run on a daily basis as mandated by the regulatory agency under which they operate After receipt of a shipment of cassettes and at monthly intervals thereafter validation should be performed by analysis of OPTI CHECK or OPTI CHECK PLUS Blood Gas Controls or other equivalent material as recommended by OPTI Medical Systems These materials should provide target values for pH PCO and all other measured parameters over a range of measurement values typically seen in each testing site laboratory The results obtained should fall within limits defined by the day to day variability as measured in the user s laboratory facility OPTI Medical recommends the following as a minimum testing frequency of QC materials Control Frequency SRC level 1 At least 1x per day in operation SRC level 3 At least 1x per day in operation OPTI Check or OPTI Check Plus Liquid month intervals and with each new shipment Controls of cassettes Operator s Manual OPTI CCA TS 4 3 4 CALIBRATION AND QUALITY CONTROL 4 5 1 Running an SRC Measurement Not Ready 10 40 12 Nov 1 From the lt Ready gt display select Control lt QC Manager gt 2 Select lt SRC gt Fig 4 1 tHb Ca
216. r gt Diagnostics e Select the Tests tab e Press Lactate Setup Fig 7 35 e Enter the setup password 404 to access the setup functions If the factory set password was changed enter the currently valid password e Enter the Operator ID or press ok to bypass this function Fig 7 36 If Operator ID is configured as required in Setup you cannot go to the next step unless a valid Op ID is entered If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID This message Fig 7 37 is displayed if lactate is already set up e Press d to keep the current settings and cancel the setup process e Press Yes to start the setup process Operator s Manual OPTI CCA TS 7 25 7 DIAGNOSTICS AND TROUBLESHOOTING isystem gt Diagnostics gt Lactate Setup Ready 10 40 12 Nov To set up lactate you have to run up to 8 ampoules of OPTI Check level 2 Fig 7 38 Please make sure d ep pmi poesi you have at least 8 ampoules of the same lot of OPTI Controls must be run Check and 8 lactate cassettes of the same lot on hand before starting setup e Press OK D run the first sample Refer to section 4 5 3 1 for instructions on running controls F Fig 7 38 Run Controls iSystem gt Diagnostics gt Lactate Setup e After each level of OPTI Check is run you Riis Ravel Cartel will return to this screen Fig 7 39 You will Using a new vial
217. r Code Scanner On Off Switch Battery Fig 1 1 OPTI CCA TS Major Components Operator s Manual OPTI CCA TS 1 3 1 INTRODUCTION Touch Screen Fig 1 2 Touch Screen Status Light Fig 1 3 Status Light Sample Measurement Chamber SMC Fig 1 4 Open SMC Cover The analyzer activities are communicated to you through a backlit Touch screen displaying the activities of the analyzer sample results and other relevant information You communicate with the analyzer through a graphical user interface The graphic interface is a touch screen used to perform all analyzer functions Fig 1 2 To the right of the display is a two color status light Fig 1 3 During operation you will see one of the following e Green Light System is ready for measurement e Blinking Green Light System is in process of calibration or measurement Do not open the cover e Red Light Major error has occurred system has stopped e Blinking Red Light System has encountered a problem and needs operator interaction before it will proceed Inside the top of the unit is the Sample Measurement Chamber SMC for the OPTI Cassette To open the cover depress the button and the cover will pop up Fig 1 4 Several LEDs and two infrared lasers are located inside the sample measuring chamber Operator s Manual OPTI CCA TS 1 INTRODUCTION Bar Code Scanner The bar code scanner on the right side of the instrument re
218. r the setup menu it must be entered prior to deleting data from the database Operator s Manual OPTI CCA TS 6 MAINTENANCE 6 MAINTENANCE E 6 1 6 14 Daily Maintenance 6 1 6 2 Weekly Nagem iach sce sesh cc xe censs acs ace Saas Ea dete eeniecteectcctentantan 6 1 6 3 Quarterly Maintenance Performing tHb Calibration 6 1 6 3 1 Performing HbCal tHb e 6 1 6 3 2 Performing HbCal Last Blood sgesekepustoeueregsgt reggesueh deet ehtedeg eet yanini oseki 6 6 G WE uer CEET 6 7 6 4 1 Replacing Peri Pump Cartridge rc edd 6 7 6 4 2 Replacing Gas Le EE 6 8 65 As Needed Maintenance acc c ana cue stee n E eeiec 6 9 6 5 1 Changing the Gas BOllB cuia ce tell as spat adc cee iban te Ep Ra enee dch 6 9 0655 Ghanging the Printer Paper issesxdsest bti beta egent degen 6 11 6 5 3 Performing Routine Clean m 6 12 Operator s Manual OPTI CCA TS 6 i 6 MAINTENANCE 6 MAINTENANCE 6 1 Daily Maintenance No daily maintenance is required for the OPTI CCA TS system 6 2 Weekly Maintenance Once a week the Sample Measurement Chamber SMC must be cleaned Open the top cover and clean the optics surface as well as the underside of the SMC cover with a lint free cloth dampened with a dilute alcohol or ammonia based cleaner as needed Be sure to remove all blood residue A cotton swab may be used for cleaning the smaller parts of the SMC 6 3 Quarterly Maintenance
219. re and the cassette s internal storage buffer in a manner similar to other combined blood gas ion analyzers In addition an optical zero point calibration of all optical channels is performed During the calibration and measurement processes diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette These tests include automatic checks of the cassette for packaging integrity temperature control fluidic control during calibration proper equilibrium behavior of the sensors during calibration and measurement automatic detection of bubbles and short sample during aspiration and automatic detection of low gas low battery dirty optics or worn pump conditions Calibration of the tHb channel is required every 3 months This calibration is performed using the tHb Calibration Cassette in a manner similar to other instruments that measure tHb and or hemoglobin derivatives optically The tHb calibration verifies the measurement optics and electronics and corrects any potential drift A second HbCal option is available on the OPTI CCA TS The HbCal Last Blood option allows the OPTI CCA TS to be correlated to another tHb measurement method When the Last Blood is run the OPTI CCA TS will compensate for any measurement bias allowing any future measured samples to match the alternate device For more information including detailed instructions on the HbCal options see Section
220. riance method Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Glucose linearity is established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions Glucose Glucose linearity in serum is by measurement of N I S T Standard Reference Material 965 Glucose in Frozen Human Serum Glucose Correlation Slope Intercept Coefficient Sy x Range n Glucose mg dL 0 9874 3 26 0 9959 7 57 30 400 126 Glucose mmol L 0 9874 0 181 0 9959 0 420 1 6 23 0 126 Glucose mg dL 1 0256 7 79 0 9912 8 13 97 306 36 Glucose mmol L 1 0256 0 432 0 9912 0 451 5 4 17 36 NIST Operator s Manual OPTI CCA TS Glu 3 GLUCOSE Correlation to Other Methods ANALYTES OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood mg dL 1 0079 0 7539 0 9932 6 509 30 400 138 mmol L 1 0079 0 04 0 9932 0 36 1 7 22 2 138
221. rmat gt E1394 lt IP Type gt Dynamic and lt UDP Port gt fields should remain at default Press m o return to the Setup screen or f nene to return to Ready Operator s Manual OPTI CCA TS Ready 10 40 22 Jul Gas 83 can Cassette Barcode Baro 732 4 CH Manual Entry Last Entry Data QC System Manager Manager Manager v Fig 3 44 Ready Display 3 3 3 6 Setting the Printer Not Ready 10 40 12 Nov Patient QC Miscellaneous Language Security Hardware Maintenance Q Up ees Fig 3 45 Select Printer System Setup Printer Not Ready 10 40 12 Nov Settings Configuration Enable Patient Reports iv Calibration Report r Append E Reference Ranges 1 2 Number of Copies Ki Cc 3 cancel fa Save LO ed Fig 3 46 Printer Settings Operator s Manual OPTI CCA TS 3 CUSTOMIZATION The lt Ready gt screen displays whether Compact Flash Card and network connection are enabled Fig 3 44 using the following icons E The compact flash card is writable Ex The compact flash card is not writable ate The network is connected d i The network is not connected This menu allows you to program the printing functions of your analyzer 1 From the lt Ready gt display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press the lt Miscellaneous gt tab and then lt Printer gt Fig 3 45 In the lt Se
222. rrelation Units Alarm Limits Q Up Home Fig 3 17 Measured Parameters Qc ISystem Setup Measured Parameters Disable Parameter cancel pl Save Q Up Home Fig 3 18 Select Allow Blanking Operator s Manual OPTI CCA TS 3 CUSTOMIZATION 3 3 2 2 Selecting Which Parameters Are Blanked Disabled In the Measured Parameters menu you can enable parameter blanking and disable certain parameters from being reported on the analyzer 1 From the Ready display select System Manager and Setup 2 Inthe System Setup menu press Measured Parameters Fig 3 17 3 Press Allow Blanking gt to allow parameter blanking Fig 3 18 If blanking is enabled the user is prompted to choose which measured parameter will be disabled or removed from the record after each patient sample measurement If for example Ca is disabled this result will not appear in the stored patient results or on the printout 4 Select the parameters to be disabled 5 Press N ss to save the settings 6 Press C SE m return to the Setup screen Or Home to return to lt Ready gt 3 9 3 CUSTOMIZATION 3 3 2 3 Selecting Which Calculated Parameters Are Printed Not Ready 1040 12 Nov Patient Miscellaneous SRC Control Customizing Patient Information Measured Parameters Normal Ranges Correlation Units Alarm Limits Up Fy Home Fig 3 19 Select Calculated Param
223. rts 4 14 Ready 10 40 12 Nov Measurement Reports Statistics Calibration Reports Patient SRC Controls Errors Miscellaneous Reports Configuration Maintenance Q Up f Home Fig 4 29 Select Controls Data Control Measurement Ready 10 40 12 Nov Level Date ien 12 Feb ll Fr mm Ga Print 12 Feb AC Delete 12 Feb kel Export 12 Feb g Mark EEZ 9 7 32 Feb Qu Statistics a Down Q Up Fy Home Fig 4 30 Controls Measurement Data gt Control Measurement gt View Ready 10 40 12 Nov Para Result Limits Pass meter Fail pH 7 42 7 417 7 431 PASS PCO2 40 1 39 1 41 1 PASS PO 89 7 886 926 PASS EN 6 00 6 10 FAIL EIEREE ILS Na 14933 148 5 150 5 PASS 1 21 1 17 125 Q Up Py Home Fig 4 31 View Control Results Your OPTI CCA TS can print control measurement reports and statistical information Koch p Me In the Ready display select Data Manager gt Press Controls Fig 4 29 In the Data Control Measurement screen Fig 4 30 press the er button to display the Control results Fig 4 31 Use the Sue and 0o buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 4 30 To print groups of results highlight the first measurement to be printed press Q i then select the last measurement to b
224. s 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 OPTI Medical Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI CCA TS CI 3 ANALYTES GLUCOSE Glucose Glu Clinical Significance Glucose is the primary energy source of the body with the brain and erythrocytes being totally dependent upon glucose for their energy requirements Therefore the blood glucose concentration plays a central role in energy metabolism and its maintenance is essential for survival The concentration of glucose in the blood is determined by a balance between the utilization of glucose and its intake from the diet or from synthesis within the body Alterations in this balance may produce either hyperglycaemia elevated blood glucose levels or hypoglycaemia low blood glucose levels Both of these conditions have serious consequences for health and require treatment which explains why measurement of blood glucose is one of the most frequently requested laboratory tests In addition the treatment for hyperglycaemia has the potential to make the patient hypoglycaemic if the patient is not carefully monitored Abnormal Levels Hyperglycaemia can be due
225. s System Manager and Diagnostics Select the Tests tab Press Printer to start the test Fig 7 15 The printer will output a test print Check if the alphanumeric printout is legible and all the characters are properly printed If the printout is deficient your printer may need replacement To replace the printer follow the steps below Turn the OPTI CCA TS off Remove the paper roll and pump cartridge Unscrew the two thumbscrews holding the printer in place Pull printer up and out towards the paper tray Disconnect the cable from the receptacle Install the new printer in reverse order Operator s Manual OPTI CCA TS 7 2 13 Checking the Optics ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Printer RS232 Flow Pump Display Touch Gas Test Lactate Setup Ethernet Q Up Home Fig 7 16 Optics Test Barcode Insert SRC OK Cancel Fig 7 17 Insert SRC Optics Test Test in Process Fig 7 18 Optics Test Optics Test Remove SRC Fig 7 19 Remove SRC Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING This option checks the output of the six optics channels This test is designed for trained service personnel From the Ready display press lt System Manager and Diagnostics e Select the Tests tab e Press Optics to start the test Fig 7 16 e Insert an SRC and press Ur
226. s C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 Operator s Manual OPTI CCA TS 8 11 8 OPERATING PRINCIPLES 8 5 9 Limitations The performance characteristics are affected by the following sample considerations The preferred test liquid is whole human blood for all parameters It is necessary to tonometer blood to obtain values to evaluate accuracy of PO and PCO because patient samples must be considered to be unknown Tonometry of blood introduces potential errors unrelated to the blood gas system being evaluated Accuracy of the gas values used temperature control and thermostatting of the tonometer humidification of the tonometry gases duration of tonometry and transfer of the sample from the tonometer to the instrument for analysis are examples of potential pre analytical error pH of blood cannot be predicted in tonometry All tonometered samples analyzed in these studies were analyzed in duplicate on an AVL 995 to establish correlation Precision of PCO and PO measurement as well as pH was evaluated over a 20 day period using two OPTI CCA TS systems with two replicates per run using a commercially available solution of reduced bovine hemoglobin which has been demonstrated to be comparable to tonometered whole blood The OPTI CCA TS system is designed to measure whole blood serum or plasma to be controlled with Standard Reference Cassettes on a daily
227. s Contro Tests Versions OPTI CCA 3 000020 2 00 0001 Optics 3000020 2000 Temperature Readings Top Plate 317 C Ambient 517 Bottom Plate 317 C Ga Gas Pressure High 99 _New LEDs Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 lon 1248 SMC Cover Close Miscellaneous Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V Q Up Home Fig 7 3 Temperature 7 2 3 Checking Gas Pressure ste m gt Diagnostics Not Ready 10 40 12 Nov Sensors Control Tess Versions OPTICCA 3 000020 2 00 0001 Optics OPTIC2H GUI 3 000020 2 00 0001 Temperature Readings Top Plate aom Plate 317 C Gas Level Gas Pressure High 99 New Front M o Yes Rear 1436 Cassette Detect 760 lon 1248 SMC Cover Close Miscellaneous Barometric Pressure 7234 mbarlkPa Battery Voltage 156 V Q Up Home Fig 7 4 Gas Pressure Gas Purge OK Cancel Operator s Manual OPTI CCA TS From the Ready display press System Manager gt Diagnostics The Temperature option lets you check the various system temperatures Top Plate Bottom Plate and Ambient Fig 7 3 NOTE If top or bottom plate temperatures are out of range the temperature display will change to red The Gas Level option allows you to check the percent remaining of the gas bottle Fig 7 4 With a new gas b
228. samples require the proper amount of anticoagulant to prevent the sample from clotting DO NOT use anticoagulants such as EDTA citrate oxalate etc Use only heparin salts as anticoagulants WARNING Sedimentation of red cells may occur rapidly in whole heparinized blood This may affect your tHb results Make sure your sample is free of trapped gas bubbles and completely mixed by rolling the syringe between the palms of your hands and inverting end over end for at least one minute just prior to sample introduction 5 4 Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING 5 3 Running A Patient Sample Whole Blood Serum and Plasma Ready m x 1040 TSM The OPTI CCA TS Analyzer is fast and easy to cas Scan Cassette Barcode operate Whenever lt Ready gt appears on the display NES the unit is ready for sample measurement 732 4 al 1 Turn on the OPTI CCA TS and wait until this display appears Fig 5 1 i t d Manual Entry Last Entry Data Qc System MORD eee eee 2 Enter the password if requested Fig 5 2 i NOTE During warm up the OPTI CCA TS checks the gas pressure Once the gas bottle pressure reaches 10 or less the value will be displayed in red If the pressure is too Enter Password low a warning will appear alerting you to low gas or no gas If no gas remains refer to section 6 5 1 of this manual to remove and install a new gas bottle Fig 5 1 Ready Displa
229. santxtusnsastinoedaveasiguoadunitanonsnemasareanasbeneeumaaaneanent 7 16 2 10 Checking the Factory Settings E 7 17 7 2 11 Checking the Bar ee E EE 7 17 1 212 Checking the ie 7 18 152 19 Checking the ODUCS e 7 19 e Mere pediatra ERR 7 20 PNE NR eor e depict 7 21 1 2146 Checking the Pump MOtOT P 7 22 2 1f Checking KE 7 22 2 18 Checking the Touch EE 7 23 Dee VO ET E none 7 24 7 2 20 Lactate Gen 7 25 7 2 21 Checking the Ethernet Interface issesccssinscesncsisarisdenenerdersuniaseaushitanectiiesessduesuuenenddabaweenten 7 27 7 2 22 CalibrationifRepOLts EE 7 28 7 2 22 1 Patient Calibration Report 7 28 1 2 22 2 SRC Calibration Report eire Ep erit pert apa Ta uuo ARRA eaten 7 29 7 2 22 3 Control Calibration Report 7 30 1 2 22 4 Emor LO EE 7 31 7 2 22 5 Configuration Report 7 32 12 226 Maintenarice Log iiic Aileen teat res la ee edo vada onal a 7 32 7 3 Troubleshooting Procedure for tHb SO seres 7 33 7 4 Troubleshooting Procedure for Bar Code Scanner 7 34 Operator s Manual OPTI CCA TS T i 7 DIAGNOSTICS AND TROUBLESHOOTING 7 DIAGNOSTICS AND TROUBLESHOOTING Your OPTI CCA TS Analyzer is designed to provide trouble free service However any measuring device may occasionally malfunction requiring you to identify the cause of the problem and initiate corrective acti
230. select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press lt Correlation gt Fig 3 25 3 Select the numbers you want to change by pressing Edit Fig 3 26 Enter the new numbers 4 Press lt Factors 2 gt to go to the next screen Fig 3 27 5 When entering the actual offset value select whether it is an additive or subtractive value using the keys NOTE The factory setting is 1 0 00 for all slopes and 0 0 00 for the offsets This deactivates the correlation factors 6 Continue through the other parameters setting their correlation factors as above 7 Press see to accept the changes 8 Press UP lto return to the lt Setup gt screen or Home to return to lt Ready gt CAUTION Since altering the correlation factors will alter your measurement results be very careful to enter the correct values and confirm the settings by running at least 10 comparison measurements between the OPTI CCA TS and the instrument to which it is to be correlated 3 13 3 CUSTOMIZATION 3 3 2 6 Defining Units This menu lets you change the units of measure for pressure temperature output resolution total hemoglobin Ca Glu BUN urea and Lac ES ae 1 From the lt Ready gt display select System Manager and Setup Not Ready 1040 12 Nov Patient Miscellaneous ac Customizing Patient Information 2 Inthe System Setup menu press Units
231. sert the cassette into the chamber Press down to ensure that the cassette is seated properly Fig 4 19 NOTE Run cassettes immediately after opening pouch if possible but no later than 15 minutes after opening the pouch Operator s Manual OPTI CCA TS 4 CALIBRATION AND QUALITY CONTROL Measuring 10 40 12 Nov Gas 83 Close Cover Baro 7324 Be 10 Close the SMC cover Fig 4 20 Cancel Fig 4 20 Close Cover Measuring 10 40 12 Nov 11 The system starts to calibrate Fig 4 21 Ge The green status light is now lit indicating that Control Calibration In a measurement is occurring and that the sample Progress Please Wait chamber cover should not be opened Calibrating o NOTE If the sample measurement chamber cover is opened while the green status light is blinking the cassette calibration will be cancelled and the cassette must be discarded 12 Calibration is complete and it is time to place a Fig 4 21 Control Calibrati ig ontrol Calibration sample 19 4 057 e Remove an ampoule from the box of controls and invert gently to resuspend the Measuri 10 40 12 No S scattering particles being careful not to heat ox Mix and Place Control it with your hands Baro 7324 pu NOTE Do not shake ampoule vigorously Excessive bubble formation may affect results e Gently tap the head of the ampoule with your fingernail to remove any liquid e
232. sion of guidelines for the collection of acceptable specimens instrument calibration and quality control in pH and blood gas analysis including details of many potential sources of error which may cause inaccurate results Whole blood samples should be collected in a heparinized syringe ComfortSampler or capillary and analyzed as soon as possible after collection Immediately after collection check the syringe or other device for air bubbles and carefully expel any trapped bubbles following the manufacturer s recommended procedure Extreme caution should be used to avoid needle stick injury If collected in a syringe or vacuum tube mix the specimen thoroughly with anticoagulant by gentle inversion or by rolling the syringe between both hands Properly identify the specimen following usual procedures for such documentation Place the syringe containing the specimen in an ice slurry Blood gases pH and glucose content will change if the specimen remains at room temperature in a syringe for more than 5 minutes due to cellular metabolism PO changes due to oxygen consumption may be influenced by several factors including white blood cell count reticulocyte count storage temperature and initial PO value At storage temperatures of to 5 C the results obtained from the specimen are valid up to 2 hours Samples expected to have high white blood cell count reticulocyte count or high PO values should be analyzed as soon as possible after
233. sitive Airway Pressure CPAP Rate f Flow Rate Liter Flow FR Inspiratory Expiratory Ratio I E Ratio Bi Level Pressure User Field 1 2 3 8 8 PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure 0 to 4000 0 0 to 120 0 0 to 140 0 0 to 100 0 0 to 99 9 0 0 to 50 0 0 to 50 0 0 to 155 0 0 to 300 0 0 2 9 9 0 2 9 9 0 0 0 2 9 9 0 2 9 9 0 0 9 alphanumeric characters Blank 0 1 0 1 1 LPM 0 1 0 1 Operator s Manual OPTI CCA TS 8 OPERATING PRINCIPLES 8 5 4 Calculated Values Parameter Range Display Units Resolution Actual bicarbonate HCO 1 to 200 0 1 mmol L Base excess BE 40 to 40 0 1 mmol L Base excess ecf BE 40 to 40 0 1 mmol L Base excess actual BE 40 to 40 0 1 mmol L Buffer base BB 0 to 100 0 1 mmol L Total CO tCO 1 to 200 0 1 mmol L Standard bicarbonate st HCO 1 to 200 0 1 mmol L Standard pH st pH 6 5 to 8 0 0 001 pH units Oxygen saturation SO c 0 to 100 0 1 Oxygen content O ct 0 to 56 0 1 mL dL Hematocrit Hct c 15 to 75 1 Hydrogen ion concentration CH 1000 to 10 0 1 nmol L Alveolar arterial oxygen difference 0 to 800 0 1 mmHg AaDO Anion Gap AG 3 to 50 1 mmol L Pa 15 to 35 0 1 mmHg nCa 0 1 to 3 0 0 1 mmol L 8 5 5 Calibration Each lot of O
234. ss Cancel to return to the Ready display and retry after installing a new cassette Operator s Manual OPTI CCA TS ERROR Cassette Misseat 2 Re insert Cassette OK Cancel Ka ERROR Cassette Misseat 2 Discard Cassette OK E ERROR Bad Cassette Discard Cassette OK E ERROR Bad Calibration Discard Cassette OK i Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The cassette was not properly placed into the chamber or it was previously used e Open the SMC cover remove and reinsert the cassette and close the cover Optionally tap the cassette firmly on the tabletop to dislodge bubbles OR e Press OK to use a different cassette Make sure to wipe the new cassette dry before inserting it into the SMC e Ifthe message still appears with a different cassette turn the power off and wait 30 seconds Then turn the power back on and retry The cassette was not properly placed into the chamber or it was previously used e Press 0K discard the cassette and repeat test with a new cassette e Ifthe message still appears with a different cassette turn the power off and wait 30 seconds Then turn the power back on and retry The cassette or its packaging is defective e Press OK discard the cassette and repeat test with a new cassette Make sure to wipe the new cassette dry before inserting it into the SMC e Ifthe message still appears wit
235. stic pKa lo 1 10 Ps l R 10 P PKa R is the ratio of minimum fluorescent intensity pH gt gt pKa to maximum fluorescent intensity pH lt lt pKa pH optodes do not need a reference electrode to measure pH however they exhibit a small sensitivity to the ionic strength of the sample being measured Measurement Range Range Resolution Low High Units 6 6 to 7 8 0 01 0 001 pH units Operator s Manual OPTI CCA TS pH B 1 pH Dry Sensor ANALYTES Standard Reference Cassette SRC Limit Values LOW NORMAL 7 100 0 02 7 400 0 02 Interferences HIGH Units 7 600 0 02 pH units Tonometered whole blood samples were spiked with a number of endogenous and exogenous chemicals and tested for interference following the CLSI guideline EP7 A2 Chemical Interferent pH Level Interference Concentration 7 170 NO Acetaminophen 1 66 mM 7 520 NO 7 170 NO Acetylsalicylic acid 3 33 mM 7 520 NO 7 170 NO Ascorbic acid 0 23 mM 7 520 NO 7 170 NO B Hydroxybutyric acid 16 03 mM 7 520 NO 7 170 NO Bilirubin 0 26 mM 7 520 NO 7 170 NO Cardiogreen 0 0065 mM 7 520 NO i 7 170 NO Cystein 6 41 mM 7 520 NO 7 170 NO Ethanol 86 8 mM 7 520 NO 7 170 0 140 Evans blue 0 0104 mM 7 520 NO 7 170 NO Glycolic acid 10 mM 7 520 NO 7 170 NO Halothane 0 759 mM 7 520 NO 7 170 NO Ibuprofen 2 43 mM 7 520 NO 7 170 NO Intralipid
236. sult of obstructive or restrictive respiratory diseases Measurement Principle The pH optode measurement principle is based upon pH dependent changes of the luminescence of a dye molecule immobilized in the optode Such pH indicator dyes have been used by chemists for many years to perform acid base titration in turbid media The relationship of luminescence to pH is quantified by a variant of the Mass Action Law of chemistry I I 1 107 which describes how the fluorescence emission intensity increases as the blood pH is increased above the dye s characteristic pKa2 pH optodes do not need a reference electrode to measure pH however they exhibit a small sensitivity to the ionic strength of the sample being measured Measurement Range Range Resolution Low High Units 6 6 to 7 8 0 01 0 001 pH units Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 7 100 0 02 7 400 0 02 7 6002 0 02 pH units Operator s Manual OPTI CCA TS pH 1 pH ANALYTES Interferences Optode pH measurements have a known sensitivity to the blood ionic strength which is determined primarily by variation in serum levels of sodium The OPTI CCA TS utilizes an internal Na sensor to actively compensate and correct for this sensitivity That is the OPTI CCA TS s reported pH has no measurable interference from hyponatremic or hypernatremic samples nor for ionic strength variations within the physiologic limits of 100 to 190 mmol L
237. t concentrations of micro beads to simulate low medium and high hemoglobin blood samples OPTI CHECK and OPTI CHECK PLUS provide a method of performing daily QC checks for laboratories selecting to measure liquid QC material 8 5 7 Reference Intervals Reference intervals are useful in describing typical results found in a defined population of apparently healthy people Reference intervals should not however be used as absolute indicators of health and disease due to variability among methods laboratories locations and other considerations Individual laboratories should generate their own set of reference intervals Guidelines for defining and determining reference intervals are published in the 2000 NCCLS C28 A2 guideline How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guideline Second Edition The analyzer is preset to adult reference intervals derived from Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 pps 2252 2302 The preset intervals and procedures for adjusting the intervals to those derived for the individual laboratory are described in section 3 3 2 4 of this manual 8 5 8 Specific Performance Characteristics All performance data in this section was generated on OPTI CCA TS systems with the SRC run daily to check QC Quality control material was run with each new lot of cassettes 2 Tietz Burti
238. t instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method pH 2 Operator s Manual OPTI CCA TS ANALYTES pH Linearity Wherever possible linearity for the OPTI CCA TS measurement has been established against reference materials or methods Linearity for pH of whole blood is established by measurement of blood specimens which were tonometered to various CO values and measured on an AVL 995 pH Blood Gas Analyzer standardized to N I S T traceable pH buffers and on three OPTI CCA TS systems Correlation Slope Intercept Coefficient Sy x Range n 1 0174 0 1099 0 99972 0 006 6 85 7 67 81 Correlation to Other Methods OPTI CCA TS vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas analyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlation Comparative Method Slope Intercept Coefficient Sy x Range n Analyzer A whole blood 0 9269 0 534 0
239. tates and or other countries Other trademarks are the property of their respective owners Made in U S A gaal OPTI Medical Systems Inc 235 Hembree Park Drive Roswell GA 30076 USA www optimedical com PD7040 REV H Important Information Important Information This Operator s Manual contains important warnings and safety information to be observed by the user This instrument is only intended for one area of application which is described in the instructions The most important prerequisites for application operation and safety are explained to ensure smooth operation No warranty or liability claims will be covered if the instrument is applied in areas other than those described or if the necessary prerequisites and safety measures are not observed The instrument is only to be operated by qualified personnel capable of observing these prerequisites Only accessories and supplies either delivered by or approved by OPTI Medical Systems are to be used with the instrument Due to this instrument s operating principle analytical accuracy not only depends on correct operation and function but also upon a variety of external influences beyond the manufacturer s control Therefore the test results from this instrument must be carefully examined by an expert before further measures are taken based on the analytical results Treatment should never be administered based on results that are flagged on the printout
240. tered here will reside in the instrument memory even after system power is turned off 8 Press C SE lto return to the lt Setup gt screen or Home to return to lt Ready gt 3 12 Operator s Manual OPTI CCA TS 3 3 2 5 Setting up Correlation Factors Not Ready 10 40 12 Nov Patient Miscellaneous Qc SRC Control Customizing Patient Information Measured Parameters Normal Ranges Correlation Units Alarm Limits m Q Up Home Fig 3 25 Select Correlation Patient Entry Parameters Calculated ISystem Setup Correlation gem 10 40 Factors2 D Offset pH asi gee PCO2 ex est PO2 eat Est Ne gee ura K 4 Eat ee e al gea Qon Defaults H Save Qu Home Fig 3 26 Correlation Factors 1 Factors 1 Slope Ca Ed edt Glu edt es BUN dt est Lac DEd edt tHb e Edit S02 PA Are Qoa Defaults H Save Fig 3 27 Correlation Factors 2 Operator s Manual OPTI CCA TS 3 CUSTOMIZATION Correlation factors let you correlate results from your OPTI CCA TS to other Blood Analyzers Correlation factors are available for pH PCO PO Na K Ca Cl Glu BUN urea Lac tHb and S0 NOTE Slope is a multiplicative factor and Offset is an additive factor using the following formula Correlated value Raw value slope offset 1 From the lt Ready gt display
241. the display will show a series of dashes and the printout will contain an error message stating that the result was suppressed e When a possible measurement error occurs the OPTI will flag patient results with a on the display and printout and a blinking result on the screen Repeat the measurement if possible WARNING Treatment should never be administered based on results that are flagged on the printout Operator s Manual OPTI CCA TS Measurement Results Measuring 10 40 12 Nov Measured Calculated Calibration Para Result Limits Pass meter Fail pH 7 42 7 417 7 431 PASS PCO2 40 1 39 1 41 1 PASS PO2 886 926 PASS tHb 6 00 6 10 FAIL S02 13 1 13 5 FAIL Nat 149 3 148 5 150 5 PASS 493 507 PASS 1 17 125 PASS e Fig 5 23 Calibration results Operator s Manual OPTI CCA TS 5 SAMPLE HANDLING AND PATIENT TESTING The third tab displays calibration data from the gas calibration preceding the measurement Fig 5 23 19 Open the cover and remove the cassette and press f reme to go to the next sample To edit the patient data press Patient Data NOTE The printout will automatically start when the first results are displayed This feature may be turned off in setup See Section 3 3 3 6 5 13 5 SAMPLE HANDLING AND PATIENT TESTING 5 4 Printing Patient Reports Ready 10 40 12 Nov Controls
242. thernet gt screens can be used to configure communication settings To adjust the tracking barometer within the OPTI CCA TS follow the instructions below 1 From the lt Ready gt display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press the Miscellaneous tab and then Hardware to select this function Fig 3 35 3 Inthe Settings menu press Edit to enter an offset from the true barometric pressure Fig 3 36 4 Type in the new numbers and press Bl Save to accept the value 5 Press Q Up lto return to the lt Setup gt screen or Home to return to lt Ready gt CAUTION Use the absolute barometric pressure and not the altitude corrected pressure check with your local weather service or airport NOTE You may change barometric pressure units from mmHg to mbar See section 3 3 2 6 Operator s Manual OPTI CCA TS 3 3 3 3 Beep Adjustment Syste m gt Setup gt Hardware Not Ready 10 40 12 Nov Settings Interface Ethernet Barometer Curent Offset Offset 740 mmHg Edit Beep Enable Beep Volume Backlight Autooff Enable 10 60 Battery Save Min Mode C Qoo Defaults Ba Save Qv Up Ge Fig 3 37 Enable Beep Operator s Manual OPTI CCA TS 3 CUSTOMIZATION This option lets you adjust the volume of the audible alarm Beep 1 From the lt Ready gt display select System Manager and Setup In the
243. tion Sur Care e The system will send out data and check if they Duration 23 days 03 00 00 are received Fig 7 42 Speed 100 0 Mbps tone 19215510 e Press UP lto return to the lt Tests gt screen Activity Sent Ea Received Packets 1432 2634 Q Up Fy Home Fig 7 42 Ethernet Test Operator s Manual OPTI CCA TS 7 27 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 22 Calibration Reports Ready 10 40 12 Nov Measurement Reports Statistics Patient SRC Controls Calibration SRC Controls Errors Miscellaneous Reports Configuration Maintenance Q Up Home Fig 7 43 Data Manager Patient 7 2 22 1 Patient Calibration Report Data gt Patient gt Diagnostics Ready 10 40 12 Nov Patient ID Date Re r p 2 789382456 27 Oct 10 S 4 787358987 Octi e E Q ve Fy Home Fig 7 44 Select Measurement IData gt Patient Diagnostics gt View Ready 10 40 12 Nov T Para mV Drift T w meter pH 2230 24 33 102 PCO2 301 3 04 33 103 PO2 6259 28 33 112 Nat 180 1 00 33 105 K 4524 72 33 93 Car 4913 09 9 108 ei em Fig 7 45 Patient Diagnostics 7 28 This option allows you to print calibration reports From the Ready display press Data Manager to access the Data screen Fig 7 43 The section Calibration Reports contains the
244. tion date and control type on the package insert supplied with the control material Fig 3 10 If the bar code is unavailable press Manual Entry on the Scan Barcode screen and enter the control information manually 2 Press N ss to accept NOTE If previous QC data exists the unit will prompt the user to either print and or delete this data from the database NOTE If no previous QC data exists in the database the print and delete display screens will be bypassed 3 Press e toobtaina printout of the old database 4 Press Yes to delete the old database NOTE If you do not want to change the current lot information but want to verify current programmed QC ranges press lt NO gt for both of the above options 3 5 3 CUSTOMIZATION 3 6 Syste m gt Setup gt Control Not Ready 1 Level Ranges2 Low High pH Edt 4 Edit PCO2 gedt Gro PO2 gea edit Nat gea edit K 9 gest As Cre gex f pex Qoi H Save Ov ged Fig 3 11 Confirm Assay Ranges ISystem Setup Control Level Low Ca Edt 4 Edit Gu X 4 se es BUN gea Gre La 4 t BEd tH t gedit SO2 z gea cancel Bp oe sed Fig 3 12 Confirm Assay Ranges 5 Press the Ranges 1 gt tab to confirm the assay ranges on the package insert supplied with the control m
245. to 40 0 01 mmol L Operator s Manual OPTI CCA TS BUN 1 BUN UREA ANALYTES Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units BUN 5 6 1 4 28 0 1 4 70 0 1 4 mg dL Urea 20 5 100 5 250 5 mmol L Interferences The OPTI CCA TS BUN urea sensor has no interference from ammonia or ammonium ion present at normal physiologic levels below 100 pmol L nor at hyperammonemia plasma levels of 300 umol L At extreme hyperammonemia plasma levels of 3000umol L the OPTI CCA TS BUN urea sensor will show an offset of 4 8 mg dL BUN 1 7 mmol L urea Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments BUN urea values are expressed in mg dL and mmol L respectively Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS Level 1 BUN mg dL 60 5 0 07 0 1 0 42 0 7 0 43 0 7 aqueous control solution Urea mmol L 21 6 0 02 0 1 0 15 0 7 0 15 0 7 OPTI CHECK PLUS Level 2 BUN mg dL 20 3 0 02 0 1 0 12 0 6 0 12 0 6 aqueous control solution Urea mmol L 7 2 0 01 0 1 0 04 0 6 0 04 0 6 OPTI CHECK PLUS Level 3 BUN mg dL 4 4 0 01 0 2 0 10 2 2 0 10 2 2 aqueous control solution Urea mmol L 1 57 0 003 0 2 0 035 2 2 0 035 2 2 Serum BUN mg dL 11 2 0 01 0 1 0 1 0 8 0 1 0 8 Urea mmol L 4 0 0 004 0 1 0 04 0 8 0 04 0 8
246. tration ctHb The hemoglobin is the main component of erythrocytes It serves as the vehicle for transportation of oxygen within the bloodstream and each gram of hemoglobin can carry 1 39 mL of oxygen The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells RBC because some red cells contain more hemoglobin than others Although oxygen transport is the main function of hemoglobin it also serves as an important buffer in the extracellular fluid Decreases in the amount of hemoglobin can come about as a result of a decreased concentration of hemoglobin in the erythrocytes or a decreased number of erythrocytes that contain a normal concentration of hemoglobin Decreased levels are found in anemia states hyperthyroidism severe hemorrhage and hemolytic reactions due to transfusions of incompatible blood reaction to chemical infectious and physical agents as well as various systemic diseases Increased levels are found in hemoconcentration of the blood chronic obstructive pulmonary disease and congestive heart failure ctHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data ctHb is used to screen for disease associated with anemia to determine the severity of anemia to follow the response to treatment for anemia and to evaluate polycythemia Hemoglobin
247. ttings gt menu Fig 3 46 you can select to have a patient report printed at the end of each measurement The second option lets you add a calibration report to each patient report The next option lets you add reference ranges to each patient report The last option lets you select how many copies will be printed 3 Select the options to be enabled 4 Press M n to accept the changes 5 Press Q Up lto return to the lt Setup gt screen or Home to return to lt Ready gt NOTE This setting affects the patient report only All other print functions are still active even if the patient report is not activated 3 25 3 CUSTOMIZATION 3 3 3 7 Maintenance 3 26 Not Ready 10 40 12 Nov Patient QC Miscellaneous Security Hardware ETT Q Up Home Fig 3 47 Select Maintenance Printer ISystem Setup Maintenance Not Ready 10 40 12 Nov Replace Pump i Reminder Cleaning Reminder ie NOS Weekly Monthly Cleaning c C cance Defaults fp Save 6 Up Fy Home Fig 3 48 Maintenance Options This menu allows you to select maintenance reminder options for your analyzer Any maintenance actions that you perform through the maintenance reminders will be captured in the maintenance log of the analyzer 1 From the lt Ready gt display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press the Miscellaneous tab and then Maint
248. tup Ethernet i Up Home Fig 7 23 Flow Test FlowTest Insert Cassette Cancel i Fig 7 24 Insert Cassette FlowTest Testin Process Fig 7 25 Flow Test in Process FlowTest Flow 4 48 99 9 FAIL Replace pump T Fig 7 26 Flow Test Fail FlowTest Please Remove the Cassette Fig 7 27 Remove Cassette Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING This option is designed to test the pump cartridge From the lt Ready gt display press lt System Manager gt and lt Diagnostics gt e Select the lt Tests gt tab e Press Flow to start the test Fig 7 23 e Insert a new cassette Fig 7 24 e Close the SMC cover e Wait for test results Fig 7 25 e The two numbers indicate the actual flow rates clockwise and counter clockwise Fig 7 26 If one of the two or both rates are out of range the test fails e Repeat test or replace the pump cartridge if the test fails See replacement instructions in Chapter 6 NOTE It is possible that the test fails the first time even if the pump cartridge is working correctly e Remove the cassette Fig 7 27 7 21 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 16 Checking the Pump Motor ISystem Diagnostics Not Ready 10 40 12 Nov Sensors Control Tests Barcode Printer Optics a Display Touch Gas Test Lactate Setup Ethernet Q Up Py Home Fig 7 28
249. ubble Detected DDMMMYY HH MM Stop Low Gas Operator s Manual OPTI CCA TS APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Lactate Setup Report D 10 OPTI Medical OPTI CCA TS Lactate Setup Report DD MMM YY HH MM Level 2 OPTI check OCLOt XXXX Exp MMMYY pH setup point Run pre post 1 7 4232 7 4336 2 7 4250 7 4354 3 7 4037 7 4142 4 7 4251 7 4356 5 7 4208 7 4313 AVG pH 7 4196 7 4300 SD 0 00805 Outliers 0 Scalar 1 011741 Scalar Setup PASS S N 2999 LOT 020651 Operator s Manual OPTI CCA TS INDEX A Accession No 3 7 5 9 Accessories 8 14 9 2 Alarm limits setting 3 11 Alveolar arterial oxygen difference 8 9 calculation A 12 reference ranges A 5 temperature corrected A 13 Analytes measurement ranges 1 1 A 1 reporting units 1 1 Analyzer components 1 3 customization 3 1 intended use 1 1 setup 2 2 Anticoagulants accepted types 5 1 8 3 Aspiration patient sample 5 7 Audible alarm Beep adjustment 3 21 B Backlight AutoOff 3 22 Bar code scanner cleaning 7 6 scanner description 1 5 scanner troubleshooting 7 34 test 7 17 Barometric pressure entering 3 20 range A 1 unit conversion A 8 verifying 7 14 Base excess 8 9 calculation A 9 A 10 reference ranges A 5 Battery pack installing 2 2 rechargeable 1 6 Battery save mode 3 22 Battery voltage checking 7 15 Bicarbonate Operator s Manual OPTI
250. uctions to set up the lactate parameter If QC lockout has been activated in Setup this message will be displayed if controls have not been run within the specified time e Press OK land run control materials The temperature is out of range during any kind of measurement e Press OK land continue e Ifthe error message appears again check the temperature under lt System Diagnostics gt Operator s Manual OPTI CCA TS Not Ready A 10 40 12Nov Battery OK LE A mo Not Ready Low Gas New Gas Bottle wi Data Qc System _Manager Manager Manager Not Ready A 10 40 12Nov Battery OK A 7944 Not Ready ra Temperature Out of Range Data Qc System Manager Manager Manager A 10 ut of Range Not Ready A 10 40 12Nov Not Ready Low Battery Data Qc System Manager Manager Manager AT 12 No KS Low Operator s Manual OPTI CCA TS 7 DIAGNOSTICS AND TROUBLESHOOTING The gas pressure is low e Replace the gas bottle See Section 6 5 1 The temperature is out of range e Wait for the analyzer to reach the correct temperature e Cycle the power if the analyzer does not go to Ready within a few minutes e Ifthe analyzer does not become Ready within a reasonable time check the temperature under System Diagnostics Check that ambient temperature is within operating specifications on page 2 1 T
251. ues which represent typical values The programmed default values will be printed and used for the calculated parameters unless they are changed by the operator during a measurement You can change the default values only if the parameter has been enabled After each measurement the value will be reset to the default value even after the system has been turned off Exceptions are the Hb type and P50 which remain at the selected value until the system is powered off The first parameter is tHb Fig 3 16 This is the tHb value used in calculations of various parameters if measured tHb is not available e Press Enable to display the default value for this parameter 15 0 g dL Press Edit to change this value using the numeric keypad NOTE Units for the tHb and P50 may be changed per instructions found in Section 3 3 2 3 The remaining default parameters are MCHC 33 3 FIO 0 21 RQ 0 84 Pso 26 7 mmHg NOTE The default values indicated above are the original factory settings If out of range values are entered the system automatically flags the error and shows the valid range e Press Se to accept the changes e Press C Wn m return to the Setup screen Or f none to return to Ready Operator s Manual OPTI CCA TS Not Ready 10 40 12 Nov Patient Miscellaneous SRC Control Customizing Patient Jofaemation 1 Measured Calculated Patient Ent e Parameters Normal Ranges Co
252. um Ca chloride CI glucose Glu blood urea nitrogen BUN urea lactate Lac total hemoglobin concentration tHb and hemoglobin oxygen saturation SO in samples of whole blood and pH sodium potassium ionized calcium chloride glucose and BUN urea in serum and plasma in either a traditional blood gas clinical laboratory setting or point of care locations by personnel minimally qualified to perform and report these results 8 2 Principles of Procedure Luminescence is the emission of light energy resulting from excited molecules returning to a resting state When luminescence is initiated by light it is commonly referred to as fluorescence When a fluorescent chemical is exposed to light energy of an appropriate color electrons in the molecules of the fluorescent chemical are excited A very short time later the electrons return to a resting state and in this process sometimes emit a small amount of light energy This energy is less than the excitation energy and so has a different color That is the emitted light fluorescence emission is red shifted from the excitation light and is much less intense Fluorescent optodes from optical electrodes measure the intensity of light emitted from fluorescent dyes exposed to a specific analyte The emitted light is distinguished from excitation light by means of optical filters Because the excitation light energy 1s kept constant the small amount of light that results is changed only
253. um levels may cause changes in muscle irritability respiration and myocardial function The potassium value obtained may be used to monitor electrolyte imbalance in the diagnosis and treatment of infusion therapies shock heart or circulatory insufficiency acid base imbalance therapy with diuretics all kinds of kidney problems diarrhea hyper and hypo function of adrenal cortex and other diseases involving electrolyte imbalance Measurement Principle The K ion optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion concentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion Like the pH optode the ion optodes do not need a reference electrode however several of them do exhibit a small pH sensitivity which is automatically compensated in the OPTI CCA TS using the measured pH Measurement Range Range Resolution Low High Units 0 8 to 10 0 1 0 01 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 2 5 0 3 4 5 0 3 7 0 0 3 mmol L Operator s Manu
254. unt Na change mmol L Sodium fluorescein 26 mg dL unstable Cardio indocyanine green 0 5 mg dL 18 Methylene blue 25 mg dL 2 Only clear uncolored quality control materials such as OPTI CHECK or OPTI CHECK PLUS brand aqueous controls should be used with the OPTI CCA TS system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI CCA TS instruments Sodium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK PLUS aqueous control solution Level 117 3 0 10 0 1 0 49 0 4 0 50 0 4 Level 2 142 3 0 11 0 1 0 50 0 4 0 51 0 4 Level 3 158 6 0 11 0 1 0 70 0 4 0 72 0 5 Serum 151 9 0 08 0 1 0 92 0 6 0 92 0 6 Reduced Bovine Hemoglobin 122 3 0 09 0 1 0 64 0 5 0 65 0 5 Solution Na 2 Operator s Manual OPTI CCA TS ANALYTES SODIUM All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator e Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible
255. up to 300 Operator IDs and associated PINs NOTE The 4 digit PIN must be unique and will be required by the operator to access analyzer functions The Operator ID number will be printed on all reports associated with their PIN OR 2 Select an Operator ID number to be deleted from the list of valid users currently stored in memory and press the gt lt Delete button to remove the operator ID from memory OR 3 Press the aPrint button to print the list of all operator IDs along with their associated PINs as currently stored in memory 4 Press Home to return to lt Ready gt 3 19 3 CUSTOMIZATION 3 3 3 2 Entering the Barometric Pressure Not Ready 10 40 12 Nov Patient QC Miscellaneous Security ee Printer d Maintenance Language Q Up Home Fig 3 35 Select Hardware iSystem gt Setup gt Hardware Not Ready 10 40 12 Nov e Interface terme Curent Offset 740 mmHg Edit T Barometer Offset Beep Enable Beep Volume Zei SC Backlight Autooff Enable 100 e Battery Save Of Min Min Mode e C e Qoa Defaults H Save Q Up Lei Home Fig 3 36 Enter barometric pressure 3 20 The lt Hardware gt menu consists of three screens lt Settings gt lt Interface gt and lt Ethernet gt The lt Settings gt screen is used to adjust your local barometric pressure the audible alarm and battery save mode The lt Interface gt and lt E
256. uration 23 days 03 00 00 Speed 100 0 Mbps IP Address 192 168 1 101 Activity CH Sent e Received Aw EM Packets 1432 2634 6 Up O Home Fig 3 41 Ethernet Test System gt Setup gt Hardware External Barcode Enable x Communication ASCI ASTM CF Format c c c Link Serial Ethemet c c Compact Flash Comma ES Delimiter Qoi De amp ults Eea Save Gv Gu Up Fy Home Fig 3 42 Interface iSystem gt Setup gt Hardware 10 40 Settings Interfe E1394 Format e IP Type iara IP Address co ro Subnet Mask 2552552550 d es UDP Port 670 Heat TCP Port e eat Host IP emm ea Qoi Defaults pss aS Fig 3 43 Ethernet To set up Ethernet communication Connect instrument to an active network Go to lt System gt Diagnostics gt Tests gt Ethernet gt Verify that the test status is lt Connected gt and you have a valid IP address not all zeroes Fig 3 41 Go back to menu lt System gt Setup gt Hardware gt Interface gt Fig 3 42 Choose communication format lt ASCII gt or lt ASTM gt Change communication link from lt Serial gt to lt Ethernet gt Choose the lt Ethernet gt tab Fig 3 43 Set lt TCP Port gt to what your data manager specifies is your instrument port Each analyzer type may have a different port specified Enter your computer s host IP address into the lt Host IP gt field Press el Save lt Fo
257. values are generally classified as a primary bicarbonate deficit metabolic acidosis b primary bicarbonate excess metabolic alkalosis c primary hypoventilation respiratory acidosis d primary hyperventilation respiratory alkalosis An increase in blood serum or plasma pH alkalemia may be due to increased plasma bicarbonate or a feature of respiratory alkalosis due to an increased elimination of CO due to hyperventilation A decreased pH value acidemia in blood serum or plasma may occur due to an increased formation of organic acids an increased excretion of H ions in certain renal disorders an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute as the result of pulmonary edema airway obstruction or medication or may be chronic as the result of obstructive or restrictive respiratory diseases Measurement Principle The pH optode measurement principle is based upon pH dependent changes of the luminescence of a dye molecule immobilized in the optode Such pH indicator dyes have been used by chemists for many years to perform acid base titration in turbid media The relationship of luminescence to pH is quantified by a variant of the Mass Action Law of chemistry which describes how the fluorescence emission intensity of the dry pH sensor decreases as the blood pH is increased above the dye s characteri
258. y 5 6 3 Scan the bar code on the OPTI cassette package by holding it 2 3 inches 5 8 cm from the bar 2 3 code scanner located on the bottom right hand ie corner of the analyzer Fig 5 3 e The red line from the bar code scanner OK should cover the entire bar code e A beep and a green status light indicates a valid bar code e Ared status light indicates an invalid bar code e g cassette expired Read the message on the analyzer display for detailed information See Chapter 7 Troubleshooting NOTE Refer to special handling instructions inside the cassette box for refrigerated cassettes NOTE If the bar code is damaged or unreadable press lt Manual Entry gt and enter the bar Fig 5 3 Scan Bar Code code digits using the numeric keypad Operator s Manual OPTI CCA TS 5 5 5 SAMPLE HANDLING AND PATIENT TESTING 5 6 Measurement Ready 10 40 22 Jul Gas 83 Open Cover Baro 7324 or Cancel Fig 5 4 Open SMC Cover Measurement Ready 10 40 22 Jul Open Pouch and Wipe Cassette Baro 732 4 Om 47 Insert Cassette Cancel Fig 5 5 Open Cassette Packet and Insert Cassette Measurement Measuring Gas 83 Baro Close Cover Cancel Fig 5 6 Close Cover NOTE Press the cover release button to open the Sample Measurement Chamber SMC Fig 5 4 If using the same lot number of cassette as the previous patient sample the cassett
259. y Sensor Interferences ANALYTES Tonometered whole blood samples were spiked with a number of endogenous and exogenous chemicals and tested for interference following the CLSI guideline EP7 A2 Chemical Interferent PO Level Interference Concentration 48 mmHg NO Acetaminophen 1 66 mM 416 mmHg NO m 48 mmHg NO Acetylsalicylic acid 3 33 mM 416 mmHg NO 48 mmHg NO Ascorbic acid 0 23 mM 416 mmHg NO f 48 mmHg NO B Hydroxybutyric acid 16 03 mM 416 mmHg NO CT 48 mmHg NO Bilirubin 0 26 mM 416 mmHg NO 48 mmHg NO Cardiogreen 0 0065 mM 416 mmHg NO 48 mmHg NO Cystein 6 41 mM 416 mmHg NO 48 mmHg NO Ethanol 86 8 mM 416 mmHg NO 48 mmHg 31 16 mmHg Evans blue 0 0104 mM 416 mmHg NO 48 mmHg NO Glycolic acid 10 mM 416 mmHg NO 48 mmHg NO Halothane 0 759 mM 416 mmHg NO 48 mmHg NO Ibuprofen 2 43 mM 416 mmHg NO 48 mmHg NO Intralipid 1 416 mmHg NO 48 mmHg NO Methylene Blue 0 125 mM 416 mmHg 27 62 mmHg i 48 mmHg NO Sodium Chloride 20 mM 416 mmHg NO Operator s Manual OPTI CCA TS ANALYTES Reproducibility Controls PO Dry Sensor Within Run Swr and Total ST Precision were determined from 2 runs per day with 2 replicates per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for three different lots of B Lac cassettes are shown below
260. ype Total Hemoglobin tHb Mean corpuscular hemoglobin concentration MCHC 125uL 60uL for B60 cassette heparinized whole blood plasma or serum syringe capillary or ComfortSampler automatic aspiration lt 2 minutes typically approx 1 minute to result 10 C 32 C 50 F 90 F 5 95 non condensing optical fluorescence for tHb SO optical absorbance reflectance 15 alphanumeric characters 11 alphanumeric characters 12 alphanumeric characters 14 44 C 58 111 F male female or MMM DD YYYY adult or fetal LR RR LB RB LF RF Cord Scalp where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right Femoral Cord Cord Scalp Scalp Off Pump On Pump Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass 1 26 g dL 10 260 mg dL 0 6 16 1 mmol L 29 0 37 0 Operator s Manual OPTI CCA TS O Mode FIO Respiratory quotient RQ P50 Vent Mode Tidal Volume TVol VT Minute Volume MVOL VE Peak Inspiratory Pressure PIP Plateau Pressure Pplat Pressure Support Value PS Positive End Expiratory Pressure PEEP Continuous Positive Airway Pressure CPAP Rate f Flow Rate Liter Flow FR Inspiratory Expiratory Ratio I E Ratio BiLevel Pressure User Field 1 2 and 3 Operator s Manual OPTI CCA TS A

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OPTI™ CCA-TS Analyzer Operator`s Manual