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OPTI™CCA-TS2 Analyzer - OPTI Medical Systems

1. 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 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 TS2 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 Controls Within run precision S and Total Precision S 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 3 different control levels are shown below tHb g dL OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 20 7 14 0 8 9
2. Fig 8 3 Temperature Checking Gas Pressure System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Versions Application Bootloader System Temperature Readings Top Plate 0 00C Ambient 00c Bottom Plate 000C Gas Level Gas Pressue Low LEDs Front 0 0000 Cassette Misseat No 0 00 Rear 0 0000 Cassette Detect 0 0000 lon 0 0000 SMC Cover Closed Miscellaneous Barometric Pressure 0 0 mmHg Battery Voltage 00v u le Fig 8 4 Gas Pressure OPTI CCA TS2 In the main menu press System Manager gt Diagnostics The Temperature Readings option lets you check the various system temperatures Top Plate Bottom Plate and Ambient Fig 8 3 NOTE If top or bottom plate temperatures are out of range the temperature display will change to red e Press 1 to return to the System screen or NN to return to the main menu The Gas Level option allows you to check the percent remaining of the gas bottle Fig 8 4 With a new gas bottle in place the pressure should be approx 99 with the bottle removed the pressure should be 00 In the main menu press System Manager and Diagnostics e To install a new gas bottle press new e Scan the gas bottle bar code located on the insert sheet to install a new gas bottle see Sectio
3. see 4 8 Operator s Manual OPTI CCA TS2 4 i 4 1 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 bar code is either entered manually or 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 according to the method described in Section 9 3 for each cassette style 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 a
4. System gt Setup gt Hardware Ready KI 16 20 21 Mar Barometer Current Offset Offset oommha oo LA Audio Beep Enable Iv High Low Beep Volume ol C Battery Standby Enable Shutdown Enable L r Standby M Shutdown Timeout zur DEN Cancel Defauts ER Save ES Fig 3 74 Standby This menu allows you to select options that will help conserve power to extend battery life These options are only active if the analyzer 1s operated from the battery 1 In the main menu select lt System Manager gt and lt Setup gt In the lt System Setup gt menu press the lt System gt tab and then press lt Hardware gt In the lt Hardware gt screen select the following options Fig 3 74 lt Standby Enable gt If this mode is enabled the system will automatically go into Standby after a certain time of analyzer inactivity When you enable this option you can select the number of minutes before the OPTI will go into standby mode NOTE The screen will appear dark when the analyzer is in standby mode Press the touch screen to exit standby mode and resume normal operation lt Shutdown Enable gt will shut down the instrument after a certain time period of analyzer inactivity to conserve power When you enable this option you can select the number of minutes before the OPTI will shut down To restart push the power button Press to accept the changes Press to return to the lt Setup gt s
5. uuusunnssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn pH B 1 uo anne PCO2 1 PCO Dry Sensor B Lac Cassette coococcesiis eo zn cbe db nia i a tov ea PCO2 B 1 PO e PO2 1 PO Dry Sensor B Lac Cassette i n rinci natia india nennen PO2 B 1 EO CIUBLLme Na 1 POIassum IK Pe E ie K 1 lonized Calcium Ot ug Nc T canana Ca 1 TS GF VE CI 1 Glucose Mic m en Bee Glu 1 BUN Ua E BUN 1 Lactate B Lac Cassette ME Lac 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO esee THB SO2 1 Operator s Manual OPTI CCA TS2 V TABLE OF CONTENTS APPENDIX A TECHNICAL SPECIFICATIONS A 1 Nieasurement Range en M Ea anii A 1 Barometric TE A 1 Opsrating Altitude esisin ani EEES EAEE A TEAPA EAE A 1 Pollution Boe ee A 1 Operating Parameters eege eege A 2 Input E UE A 2 Temperature Corrected Values Hee A 4 Reference Ranges nun A 5 Bata IVT IST E A 6 Mains Supply for External Power Supply eceeeceeeceeeeceeeeeeeaaeeaaeeaaeeaaeeaeeeaeeeaeeeaeeeaeeeaeees A 6 DC Supply for Instrument A 6 Overvoltage KEE T aa A 6 Dimelisiaensang WY SI Ws aaa ete oa cece cerca ee A 6 Ee e EE A 7 Calculated Parameter A 7 Temperaturen ee A 7 Units Used in Measured and Input Parameters for Calculatons A 7
6. Ready T 22 01 10 Dec Insert USB Stick To Import Export Configuration Data Jl Le Fig 6 36 Insert USB device USB Mass Storage Device Safely eject USB Mass Storage Device Fig 6 37 Eject USB device You can use this function to import or export configuration data to an XML file It includes all setup information which can be imported into any instrument 1 To import or export configuration data select lt Data Manager gt in the main menu 2 On the lt Measurement gt tab select lt Configuration gt Fig 6 35 3 Insert a USB device and select lt Export gt or lt Import gt as desired Fig 6 36 4 Toremove the USB device safely touch the USB icon d in the status bar at the top of the screen or the button lt Eject USB Mass Storage Device gt Fig 6 35 5 You will be asked to eject the USB device safely Fig 6 37 6 Select to remove the device An acknowledgement screen will be displayed when it is safe to remove the device 7 Press ES to return to the Data screen or to return to the main menu Operator s Manual OPTI CCA TS2 6 4 3 Exporting the Database Measurement Diagnostics Patient SRC Database bta Lei Fig 6 38 Select Database Data gt Database Ready 1 4 22 01 10 Dec Insert USB Stick To Export Database Fig 6 39 Insert USB device USB Mass Storage Dev
7. Cassette Calibration In Progress Please Wait Calibrating E 13 Fig 4 19 Control Calibration Fig 4 20 Place Control Fig 4 21 Attach Capillary Tube Operator s Manual OPTI CCA TS2 4 CALIBRATION AND QUALITY CONTROL 9 The system starts to calibrate Fig 4 19 The green status light is now lit indicating that a measurement is occurring and that the sample chamber cover should not be opened 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 10 Calibration is complete and it is time to place a sample Fig 4 20 11 Remove an ampoule from the box of controls and invert gently to resuspend the scattering particles being careful not to heat it with your hands NOTE Do not shake ampoule vigorously Excessive bubble formation may affect results 12 Gently tap the head of the ampoule with your f ngernail to remove any liquid 13 Carefully open the ampoule by breaking off the top NOTE Protect your fingers by using gloves or tissue while breaking ampoule 14 Either aspirate directly from the ampoule or use a capillary to withdraw a small amount of control material from the ampoule for aspiration 15 Hold the ampoule at a 45 angle during aspiration Fig 4 20 Use a new ampoule for each sample 16 When using capillary tubes push the tu
8. Select Group Functions Time and Date Patient Entry Setup Measured Parameter Setup i WA Control Measurement SRC Measurement tHb Calibrator z Cancel OK Fig 3 55 Group Functions The lt Groups gt menu is used to set up user groups and assign group permissions to perform specific functions on the analyzer 1 Select the lt Groups gt tab in the lt System gt Setup gt Security gt menu Fig 3 53 There are 2 system default user groups e The ADMIN group has access to all functions in the analyzer This user group cannot be changed or deleted however other users may be added to the ADMIN group e A User group has also been set as a default This group may be edited or deleted 2 To add a new user group press in the top section of the screen Fig 3 53 3 In the subsequent screen Fig 3 54 press Lal and type a unique name for the user group Press 4 To assign group functions to a user group press Functions Fig 3 54 e The top half of the Select Group Functions gt screen Fig 3 55 displays all available options the bottom half shows the selected options 5 To add group functions select the desired option from the top menu and press the blue lt Down gt arrow Ey to move this option to your list in the selection field on the bottom The default options for user group functions are Patient Measurement Control Measurement SRC Measurement tHb Cal
9. e Cancel Defaults B Save Fig 3 89 Reminder Options 3 40 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 l 3 From the lt Ready gt display select lt System Manager gt and lt Maintenance gt Fig 3 87 Enter User ID if enabled In the lt Maintenance gt menu Fig 3 88 press lt Setup gt In the lt Setup gt screen Fig 3 89 you can select lt Replace Pump Reminder gt to alert you when the peristaltic pump needs replacement If you enable the option lt Cleaning Reminder gt the system will alert you when weekly or monthly cleaning is due Select lt Monthly gt cleaning if the analyzer is not used weekly Refer to Chapter 7 for maintenance procedures Operator s Manual OPTI CCA TS2 4 CALIBRATION AND QUALITY CONTROL 4 CALIBRATION AND QUALITY CONTROL 4 1 4 amp 1 Calibration c ee 4 1 AZ ee citi evinced een 4 2 4 3 Proficiency E en 4 2 44 Calibration Venfication essen 4 3 45 QC R commendationS uisi issii eissien ste ds uy n RECEN Yo Ka Cu ns eaaa ia C RR eR nr 4 3 4 5 1 Running an SRC Measurement EN 4 4 45 2 R nning a QC Sample sauer n hn eos nra sensonduapsancaanaevauentavearonne DUO ADR KCN UE EU NER FF RUE 4 8 4 5 2 1 Running Controls OPTI CHECK OPTI CHECK PLUS
10. 4 96 SD 0 11 CV 2 14 Operator s Manual OPTI CCA TS2 D 5 APPENDIX D REPORT FORMATS Maintenance Report D 6 De OPTIMedical OPTI CCA TS2 MAINTENANCE REPORT DD MMM YY HH MM S N XXXX Version 1 23 4567 DDMMMYY HH MM Pump Replaced DOMO213D DDMMMYY HH MM Cleaning Completed Operator s Manual OPTI CCA TS2 APPENDIX D REPORT FORMATS Error Report nous Y OPTIMedical OPTI CCA TS2 ERROR Report DD MMM YY HH MM S N 123 Version 1 23 4567 DDMMMYY HH MM ERROR Cassette Misseat 1 DDMMMYY HH MM ERROR Cassette Misseat 2 DDMMMYY HH MM ERROR Gas Expired DDMMMYY HH MM Warning Bubble Detected DDMMMYY HH MM Stop Low Gas Operator s Manual OPTI CCA TS2 D 7 APPENDIX D REPORT FORMATS B Lac Setup Report D 8 De OPTIMedical OPTI CCA TS2 B Lac Setup Report DD MMM YY HH MM Level 2 OPTI Check QCLot 1234 Exp MMMYYYY pH setup point Run pre post 7 4232 7 4336 7 4250 7 4354 7 4037 7 4142 7 4251 7 4356 7 4208 7 4313 ak wWN Pr 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 TS2 INDEX A Accession No 3 7 5 8 Accessories 8 14 9 2 Alveolar arterial oxygen difference 8 9 calculation A 12 reference ranges A 5 temperature corrected A 12 Analytes measurement ranges 1 1 A 1 reportin
11. To print groups of results highlight the first lot to be printed press lt Mark gt el then select the last lot to be printed All the lot numbers in between will be selected Press All A to select all results Press lt Print gt to print your selection 10 Press EJ to return to the lt Data gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT 6 2 Printing Diagnostics Reports 6 2 1 Patient Diagnostics Reports Ready Y 2147 10 Dec Measurement Diagnostics Patient SRC LC Le Fig 6 15 Diagnostics Data gt Patient Diagnostics 242100 pH 3573960 66 7 32 102 4 PCO2 3473280 69 0 32 102 9 PO2 4044090 19 2 24 11077 Fig 6 17 Patient Diagnostics Operator s Manual OPTI CCA TS2 The Patient Diagnostics Report contains information about the measured signal in femtowatts and drifts observed during measurement You can print out reports of individual patient measurements groups of patient measurements or all the measurements in memory 1 To print a patient diagnostics report select Data Manager in the main menu 2 Inthe Data screen press the Diagnostics tab and select Patient Fig 6 15 3 Inthe Data Patient Diagnostics screen Fig 6 16 select the desired measurement and press the View
12. Option 3 New Lot Lockout Enable Fig 3 14 When this option is enabled controls must be run with every new lot of cassettes for patient measurements to be allowed System gt Setup gt Lockout New Lot Lockout Enable Lockout By Level Enable m T By Level By Number 1 2 3 kk i 1 2 e e Aw 1 To specify the number of QC measurements to be performed make sure lt Lockout By Level Enable is not selected and select 1 2 or 3 in the lt By Number gt option 2 To specify the levels to run select lt Lockout By Level Enable and the levels to run in the lt By Level gt option Fig 3 14 New Lot Lockout 3 By default this option is set to run 3 levels of QC with each new lot 4 To disable New Lot lockouts deselect lt New Lot Lockout Enable gt 5 Press B Save lto accept the changes 6 Press d ke return to the lt Setup gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 3 7 3 CUSTOMIZATION 3 2 2 3 2 2 1 3 8 Ready Ki 11 17 10 Dec Deeg Security ac Calculated Parameters Setting up Patient Information LEI VG Fig 3 15 Select Patient Entry System gt Setup gt Patient Information Ready Ki 11 20 10 Dec Available Functions Medical Record Number Account Number Test ID Patient Name H Selected Functions Required T Accession Number r DOB E Sex Ll D A C
13. 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 29 0 37 0 0 70 2 00 15 0 40 0 mmHg 0 2 9 9 0 2 9 9 0 2 9 9 0 2 9 9 50 alphanumeric characters 1 0 200 0 mmol L 40 40 mmol L 40 40 mmol L 40 40 mmol L 0 0 100 0 mmol L 1 0 200 0 mmol L 1 0 200 0 mmol L 6 500 8 000 0 0 100 0 0 0 56 0 mL dL 15 75 10 0 1000 0 nmol L 0 0 800 0 mmHg Anion Gap AG 3 30 mmol L P50 15 0 35 0 mmHg nCa 0 1 3 0 mmol L Temperature Corrected Values 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 A 4 Operator s Manual OPTI CCA TS2 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
14. Instrument repairs are to be performed only by the manufacturer or qualified service personnel Important Information Important Information Operating Safety Information e Overvoltage Category Il when connected to a branch circuit e This equipment has been tested and found to comply with the limits for a Class B 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 60825 1 The LEDs have been certified as an EXEMPT RISK GROUP in compliance with IEC 62471 The maximum energy output is as follows 670 nm LED 40 Microwatts max for 400ms 78
15. System gt Diagnostics gt B Lac Setup To set up the B Lac cassettes you have to run up muy SZ Lol to 8 ampoules of OPTI Check level 2 Fig 8 38 ee Please make sure you have at least 8 ampoules of the up to 8 Level 2 OPTI Check same lot of OPTI Check and 8 B Lac cassettes of the Controls must be run 2 same lot on hand before starting setup e Press to run the first sample Refer to section 4 5 2 1 for instructions on running controls Lie eine Fig 8 38 Run Controls System gt Diagnostics gt B Lac Setup e After each level of OPTI Check is run you will return to this screen Fig 8 39 You will 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 Run Level 2 Control Using a new vial Completed 0 of 5 Fig 8 39 Run Controls System gt Diagnostics gt B Lac Setup Ready Ki 14 37 28 Dec e After running the required number of samples To set up B Lac cassette i 3 up to 8 Level 2 OPTI Check the lactate parameter is enabled Fig 8 40 Cantrale munt ha run B Lac Setup Process Completed e Press to exit the menu Lactate is enabled 5 You will receive a B Lac setup report once complete After completing this procedure OPTI Medical recommends that you run two levels of OPTI Check using B Lac cassettes to verify p
16. 47 FIO PACO FIO 1 FIO R mmHg PACO PaCO alveolar PCO Apply above equation for PAO 2 PO otherwise PAO PO pH pH corrected to patient temperature other than 37 C pH pH 0 0147 0 0065 pH 7 4 t 37 pH unit CH Concentration of hydrogen ions corrected to patient temperature other than 37 C t cH 10 PH nmol L PCO PCO value corrected to patient temperature other than 37 C t 490 019 t 37 PCO PCO 10 mmHg 7 PO PO value corrected to patient temperature other than 37 C 5 4910 11 2023 88 0 071 t 9 7240 9 po53 88 2 39 us PO PO 10 mmHg AaDO Alveolar to arterial oxygen tension difference corrected to patient temperature other than 37 C u t t AaDO PAO PaO mmHg where PAO P oa DH OH FIO PACO FIO 1 FIO R with PH CH 47 10100237 0 0001 t 37 37 2 and PACO PaCO alveolar PCO arterial PCO Apply above equation for PAO PO otherwise PAO PO A 12 Operator s Manual OPTI CCA TS2 Hct c AG nCa APPENDIX A TECHNICAL SPECIFICATIONS Hct c as a function of tHb Hct c tHb g di MCHC 100 y 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 The anion gap is a calculated parameter used to express th
17. ANALYTES LACTATE 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 Heparin salts are the only recommended anti coagulants acceptable for use on the B Lac cassette Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below Lactate mmol L OPTI Check Level 1 OPTI Check Level2 OPTI Check Level 3 Days Run 20 20 20 Total Average 1 02 2 50 4 59 Within Run St Dev S 0 06 0 11 0 18 Within Run CV 5 6 4 2 4 0 Total Precision St Dev S 0 07 0 11 0 22 Total CV 6 496 4 5 4 8 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 4 6 5 9 n 12 12 12 Operator s Manual OPTI CCA TS2 Lac 3 LACTATE ANALYTES Linearity Wherever possible linearit
18. Barcode Printer Optics Display Touch Gas Test nim WEE ES Fig 8 12 Barcode Test Barcode Test Barcode Test Scan Barcode amm Fig 8 13 Scan Barcode 17115001 Fig 8 14 Barcode Test Operator s Manual OPTI CCA TS2 This option allows you to check the function of the bar code scanner In the main menu press System Manager gt Diagnostics e Select the Tests tab e Press Barcode to start the test Fig 8 12 e To test the bar code scanner scan a bar code label of e g a sensor cassette Fig 8 13 e The display will show a sequence of numbers Fig 8 14 Compare the numbers with those printed on the cassette bar code label Matching information confirms the proper function of the bar code scanner e Press to return to the Tests screen e Press K to return to the lt System gt screen or to return to the main menu 8 23 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 12 Checking the Printer System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Barcode Printer Optics Ethernet Flow Pump LU I Display Touch Gas Test id E Ere ll Setup Cassette B Lac Detect Fig 8 15 Printer Test 8 24 This diagnostic function lets you check for the proper functioning of the built in thermal printer To activate In the main menu press System Manager gt Diagnostics e S
19. Custom Header Part 2 123 MAIN STREET k l INTENSIVE CARE UNIT Q Cancel Defaults t Fig 3 64 Header Setting the Printer The lt Printer gt menu allows you to program the printing functions of your analyzer It contains three submenus lt Settings gt lt Header gt and lt Configuration gt 1 Inthe main menu select System Manager and lt Setup gt 2 Inthe lt System Setup gt menu press the lt System gt tab and then lt Printer gt Fig 3 62 In the lt Settings gt menu Fig 3 63 you can select to have a patient control and SRC report printed after each measurement In the default settings these options are activated You can also select to add a calibration report and normal and critical limits to each patient report 1 Select the options to be enabled 2 Press to accept the changes 3 Press EJ to return to the lt Setup gt screen or to return to the main menu In the lt Header gt menu Fig 3 64 you can add custom headers to your printed reports 1 Select lt Custom Header Enable gt press Kl and enter the custom header 2 Press to accept the changes 3 Press LE to return to the lt Setup gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 System gt Setup gt Printer Print Destination Internal External Both Printer Printer Printers C C Printer Port 6700 Printer IP 0000 Address Willy Kl Ka F
20. Fig 8 26 Remove Cassette Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING This option is designed to test the pump cartridge In the main menu press lt System Manager gt Diagnostics gt Select the lt Tests gt tab Press Flow to start the test Fig 8 22 Insert a new cassette Fig 8 23 Close the SMC cover Wait for test results Fig 8 24 The two numbers indicate the actual flow rates clockwise and counter clockwise Fig 8 25 If one of the two or both rates are out of range the test fails Repeat test or replace the pump cartridge if the test fails See replacement instructions in Chapter 7 4 1 NOTE It is possible that the test fails the first time even if the pump cartridge is working correctly Remove the cassette Fig 8 26 8 27 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 16 Checking the Pump Motor System Diagnostics Ready Sensors Hardware Tests Blac j Detect u KN Fig 8 27 Pump Motor Test Pump Test Pump Speed 15 RPM Fig 8 28 Pump Speed 8 2 17 Checking the Display System gt Diagnostics Sensors Hardware un V Display B Barcode Fig 8 29 Display Test 8 28 The purpose of this test is to check the proper functioning of the peristaltic pump motor In the main menu press lt System Manager gt Diagnostics gt e Select the lt Tests gt tab
21. Mask T P T Piece NC Nasal Canula Vent Vent Bag Bag Manual Resuscitation Hood Hood Other Other 3 9 3 CUSTOMIZATION 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 Pplat default value 0 Mvol VE default value 0 L PIP default value 0 Liter Flow default value 000 00 Lpm Tvol VT default value 0 mL PS default value 0 PEEP default value 0 Rate f default value 0 bpm CPAP default value 0 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 Bilevel Pressure default value 0 00 0 00 VE Ratio default value 0 Comment field 50 alphanumeric characters 5 The options will be shown in the patient entry form during a patient measurement in the order they are listed in the lower box The order can be changed by selecting the desired option in the lower box and pressing the lt Up gt Ei or lt Down gt LA arrow buttons to the right of the selection box to move the option up or down in the list 6 Press Sae
22. Sensors Control and Tests P 5 Fig 8 1 Diagnostics 8 2 1 Checking Versions See In the main menu press lt System Manager gt Ready 16 19 21 Mar Diagnostics gt Sensors Hardware li Tests Versions Application The first option on the lt Sensors gt screen System lt Versions gt Fig 8 2 allows you to check the Temperature Readhgs Top Plate 0 00C Ambient 0 0C system versions Bottom Plate 0 00C Gas Level Gas Pressure Low 0 00 New e Press to return to the lt System gt screen LEDs FA Front 0 0000 Cassette Misseat No or f to return to the main menu Rear 0 0000 Cassette Detect 0 0000 lon 0 0000 SMC Cover Closed Miscellaneous Barometric Pressure 0 0 mmHg Battery Voltage 00v u KN Fig 8 2 Versions 8 18 Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 2 Checking System Temperatures 8 2 3 Operator s Manual LEDs System gt Diagnostics Ready 9 16 19 Versions Application Bootloader System Temperature Readings Top Plate Bottom Plate 21 Mar Sensors Hardware Tests Gas Level 000C Ambient 00c Bottom Plate 0 00 C Gas Pressure Low 0 00 N Front 0 0000 Cassette Misseat No Rear 0 0000 Cassette Detect 0 0000 lon 0 0000 SMC Cover Closed Miscellaneous Barometric Pressure 0 0 mmHg Battery Voltage 00v E Ere
23. am Page 2of4 cH 36 0 44 0 nmol L AaDO2 5 0 20 0 mmHg AnGap 10 0 20 0 mmol L P50 25 0 29 0 mmHg Fig 3 32 Enter Limits 2 nCa 0 10 3 00 mmol L Operator s Manual OPTI CCA TS2 3 15 3 CUSTOMIZATION 3 16 Sys gt Setup gt Calculated Limits Not Ready Reference Enable Li Low High Hco3 10 K i 200 k WM i BEect 400 LA BEact 200 L Page 1 of 4 Defaults ES Fig 3 33 Enter Critical Limits Sys gt Setup gt Calculated Limits Not Ready Reference Critical Low High m E me vo 10 kl 2000 u stHcOS 10 Kl 200 stpH eso i so LA sozic oo A oo kal Back Page 2 of 4 Leen JE Ka Fig 3 34 Critical Limits 2 Sys gt Setup gt Calculated Limits Not Ready Reference Critical Low High oe o gj sso gi Hec Ten y Ten k EN m AaDO2 oo j soo k AnGap 30 A 200 i Back Page 3 of 4 u KO Fig 3 35 Critical Limits 3 e To change units of measure see section 3 2 4 2 NOTE Each facility should establish their own reference ranges The preset analyzer ranges are for reference only and are derived from Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 pps 2252 2302 5 Select the lt Critical gt tab Fig 3 33 By default critical ranges are disabled Press
24. g 4 lt E E BE a g E F A beep and a green status light indicates a valid bar code 23 Z3 EE E E 2 If Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you UE A will be asked to enter the user ID Fig 7 4 Depending on security settings user access to running Hb calibrators may be restricted NOTE Bar coded user IDs may be entered from this TE BT screen using the bar code scanner Scan Cassette Barcode Fig 7 4 Enter User ID Ready 3 A warning will be displayed the first time a new tHb Calibrator lot is used Fig 7 5 Press lt Continue gt WARNING New tHb Calibrator Cancel Continue Manual Entry Last Entry Qc System Manager Manager Fig 7 5 New Calibrator Gas 99 Baro 737 7 Operator s Manual OPTI CCA TS2 Clean Optics and Inside of Cover m Fig 7 6 Clean Optics Measuring Ki 22 44 04 Jan Open Cover Fig 7 7 Open Cover Measuring Kl 22 45 04 Jan Insert Cassette Fig 7 8 Wipe and Insert Cassette Operator s Manual OPTI CCA TS2 7 MAINTENANCE 4 Gently clean the optics window and the inside top cover of the sample chamber with a soft lint free cloth Press Fig 7 6 5 At the prompt open the SMC cover by pressing down on the red latch Fig 7 7 6 Gently wipe both sides of the tHb Calibrator
25. 19 9 mg dL Urea 2 1 7 1 mmol L Lac 0 90 1 70 mmol L AN ES Wu 12 0 17 0 g dL Fig 3 26 Enter Limits 2 50 20 0 100 0 Operator s Manual OPTI CCA TS2 3 13 3 CUSTOMIZATION 3 14 Sys gt Setup gt Measurement Limits Enable Low High Pco2 100 gj 2000 ka Po2 wo L i 7000 k Na 1000 Back Page 1 of 3 Critical SE High K oo i ee E m en a e cu 55 K i soo kal mm 2s v2 gj Back Page 2 of 3 Cancel Defaults Fig 3 28 Critical Limits 2 Sys gt Setup gt Measurement Limits Reference Critical Low High ie fom a Pro bal tb so g 250 k soz coo L i Jee kal Back Page 3 of 3 Fig 3 29 Critical Limits 3 e For information on how to change units of measure see section 3 2 4 2 NOTE Each facility should establish their own reference ranges The preset analyzer ranges are for reference only and are derived from Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 pps 2252 2302 6 Select the lt Critical gt tab Fig 3 27 By default critical ranges are disabled Press lt Enable gt to enter critical limit values 7 Select the parameter you want to change and press Kl to enter the new limit value 8 Press to access pages 2 and 3 with the remaining parameters Fig 3 28 and Fig
26. 6 28 4 Press to delete the maintenance database NOTE If you do not have permission to delete records the Delete button will not be active Fig 6 28 Maintenance Report 5 Confirm your choice by pressing in the SEENEN lt Delete the Maintenance Log gt screen Ye Fig 6 29 6 Press 44 to return to the Data screen or Fig 6 29 Delete Maintenance Log ee ne A ne Operator s Manual OPTI CCA TS2 6 11 6 DATA MANAGEMENT 6 4 6 4 1 Exporting Measurement Data 6 12 Importing Exporting Data The OPTI CCA TS2 provides you with the ability to export Patient and QC information to a connected computer or HIS LIS Prior to sending data to a computer the OPTI CCA TS2 communication port must be configured in Communications Setup see Section 3 2 4 5 and a physical connection to the receiving computer must be made Not Ready e Measurement Diagnostics 11 09 27 Dec Patient Controls 1 Miscellaneous Reports Configuration Maintenance Fig 6 30 Select Data Data gt SRC Measurement JLR121 21 10 Dec 12 2 Ann 10 Dec 12 3 JLR121 2 Fig 6 31 Export Data 1 To export measurement results select Data Manager in the main menu 2 On the lt Measurement gt tab select Patient lt SRC gt or Control
27. Cleaning c next analyzer cleaning is due 4 After you perform the analyzer cleaning procedure go to the Maintenance screen Fig 7 1 and press next to Cancel Defauts P Save Cleaning ER The date of the last cleaning will be displayed for future reference Fig 7 2 Select Cleaning Operator s Manual OPTI CCA TS2 7 1 7 MAINTENANCE 7 2 7 3 Quarterly Maintenance Performing tHb Calibration Kl 17 53 04 Jan Scan Cassette Barcode Read Calibration of the tHb channel is required every 3 months This calibration is performed using the tHb Calibrator Cassette and verifies the measurement optics and electronics and corrects any potential drift The tHb Calibrator Cassette can be found in the storage compartment in the back of your analyzer UT y E pone A 1 Inthe main screen scan the bottom bar code Manual Entry Last Entry j on the calibrator cassette package by holding it QC Syst j mmm wus mam 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the Gas 99 s Baro 737 7 analyzer Fig 7 3 Fig 7 3 Scan Bar Code NOTE A tHb calibration can also be run from the QC menu by pressing QC Enter User ID Manager gt QC gt tHb Calibrator gt instead of scanning the barcode in the lt Ready gt screen 3 Ir E E E t The red line from the bar code scanner should cover the entire bar code
28. Conversion Table for Units ENNEN A 8 EqQuatiONns A 8 APPENDIX B MENU STRUCTURE uu uu en B 1 APPENDIX C MAINTENANCE LOG ENER eene nnn C 1 APPENDIX D REPORT FORMATS 4 u D 1 Basic GIE le EE D 1 SRC Measurement Report sss cee eee seeeeeeeeeeseeeeeeeeeeeeeeeeeeeeeees D 2 SRC Statistics Report u neck une D 3 Controls Measurement Report D 4 Controls Statistics Repor ana aa D 5 Maintenance Report D 6 Singel ln dE D 7 Beete EE EE EE D 8 12 E l 1 VI Operator s Manual OPTI CCA TS2 1 INTRODUCTION 1 INTRODUC Eeer cc 1 1 1 1 Intended Use nenn 1 1 1 2 Principles of Operation nu ae ee 1 1 1 3 GONtents ee 1 2 14 Analyzer Componente cedcnwininn ini 1 3 1 5 COMMS UNA UE 1 8 Operator s Manual OPTI CCA TS2 1 i 1 1 1 2 1 INTRODUCTION INTRODUCTION Intended Use The OPTI CCA TS2 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 KL 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
29. Fig 3 44 to access the Settings menu You will be asked to enter User ID and Password factory setting ADMIN ADMIN Fig 3 45 Operator s Manual OPTI CCA TS2 3 2 3 1 1 Security Settings l System gt Setup gt Security Not Ready Ki 11 42 10 Dec Settings Users Groups User ID Entry Non secure r1 Secure Expiration Enable ri Logon Timeout minutes o pa LEI Fig 3 46 Security Settings Not Ready Ki 11 42 10 Dec Settings Users Groups User ID Entry Non secure Password Enable E Expiration Enable ni Logon Timeout minutes o Il ome pen JD seve afia WC A Fig 3 47 Non secure User ID System gt Setup gt Security Not Ready Ki 11 43 10 Dec Settings Users Groups User ID Entry Secure Password Enable L Expiration Enable DO Logon Timeout minutes o LI zen pre JD save Lt Fig 3 48 Secure User ID Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION The lt Security Settings gt menu has various security options 1 To disable all security options select lt None gt in the lt User ID Entry gt drop down box Fig 3 46 With all security disabled the only menus that require user ID and password entry are the Fset Factory Settings Time Date and Security Setup menus Time Date and Security Setup menus use the defaults ADMIN ADMIN FSet requires a different User ID and password The defaul
30. Lei Fig 6 24 Select Errors Data gt Errors Ready Y 21 50 10 Dec Error Log afi icu bA Fig 6 25 Print or Delete Error Log Delete the Error Log Fig 6 26 Delete Error Log This printout reports all errors logged in the database 1 To print an error report select Data Manager in the main menu 2 Inthe Data screen press the Diagnostics tab and select Errors Fig 6 24 3 Press to print the error report Fig 6 25 4 Press to delete the error database NOTE If you do not have permission to delete records the button will not be active 5 Confirm your choice by pressing in the Delete the Error Log screen Fig 6 26 6 Press E to return to the Data screen or to return to the main menu Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT 6 3 Miscellaneous Reports 6 3 1 Maintenance Report Not Ready 9 11 09 27 Dec Measurement Diagnostics m emm This printout reports all maintenance events that were logged in the lt Maintenance gt menu Eject USB Mass see Sections 7 2 and 7 4 1 se im eg 1 To print a maintenance report select Data Configuration Maintenance Manager gt in the main menu 2 Inthe lt Data gt screen on the lt Measurement gt EA tab select lt Maintenance gt Fig 6 27 Fig 6 27 Maintenance 3 Press to print the maintenance report Fig
31. SMC for the OPTI Cassette To open the cover press down on the red SMC latch 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 TS2 Bar Code Scanner gt Fig 1 5 Bar Code Scanner Thermal Printer Fig 1 6 Thermal Printer Peristaltic Pump Fig 1 7 Peristaltic Pump Operator s Manual OPTI CCA TS2 1 INTRODUCTION The bar code scanner on the right side of the instrument reads 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 The thermal printer is accessed by pressing the red printer release button on the door Fig 1 6 The printer uses heat sensitive paper to print measured values quality control values calibration values as well as patient and diagnostic information 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 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 M
32. 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 OPTI CCA TS2 PCO2 B 1 PCO Dry Sensor ANALYTES Interferences 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 N
33. To run controls press QC Manager gt in the main menu Fig 4 12 and select lt Control gt in the lt QC gt menu Manual Entry Last Entry Data Qc System Manager Manager Manager Gas 99 Baro 737 7 N Fig 4 12 Select OC Manager 4 8 Operator s Manual OPTI CCA TS2 Enter User ID 123 Cancel OK Material Type OPTI CHECK OPTI CHECK PLUS e Select OPTI CHECK Level i i2 Exp 10 13 o ro Fig 4 14 Select QC Level GC gt Control Ready Ki 13 18 10 Dec Scan Cassette Barcode x amu Cancel Manual Entry Fig 4 15 Scan Bar Code Operator s Manual OPTI CCA TS2 4 CALIBRATION AND QUALITY CONTROL 2 If Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 4 13 NOTE Bar coded user IDs may be entered from this screen using the bar code scanner 3 Select the desired level Fig 4 14 and press OK NOTE If anew lot number of QC material is used make sure the ranges have been entered into the system prior to running a sample See Section 3 2 1 1 4 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
34. Within Run St Dev S 0 1 0 1 0 1 Within Run CV 0 3 0 4 1 2 Total Precision St Dev S 0 2 0 1 0 2 Total CV 0 9 0 8 2 5 SO OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 81 2 89 8 96 4 Within Run St Dev S 0 1 0 3 0 4 Within Run CV 0 2 0 3 0 4 Total Precision St Dev S 0 5 0 5 0 7 Total CV 0 6 0 6 0 8 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 Operator s Manual OPTI CCA TS2 THB SO2 3 tHb SO ANALYTES Linearity Wherever possible linearity for the OPTI CCA TS2 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 Correlation to Other Methods OPTI CCA TS2 vs other pH Blood Gas Instruments on whole blood in a typical setting Excess blood aliquots from specimens collected for blood gas a
35. control levels are shown below BUN mg dL OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 10 10 10 Total Average 74 1 19 3 5 9 Within Run St Dev S 3 0 0 6 0 1 Within Run 9o CV 4 0 3 2 1 9 Total Precision St Dev S 3 5 0 7 0 2 Total CV 4 7 3 7 3 2 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations Specimens at each level were analyzed in replicates of two for 10 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 TS2 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 TS2 ANALYTES Correlation to Other Methods BUN UREA OPTI CCA TS2 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 TS2 after obtaining the requisite results from existi
36. gt A control measurement has failed during B Lac Setup e Press to rerun the measurement lt WARNING Required Fields Missing Data gt If patient data options have been set up as lt Required gt in the lt Setup gt menu Section 3 2 2 the required information will have to be entered before the user can exit this screen e Press and enter the required information lt WARNING Text Length Less Than Minimum Characters Required gt If a minimum number of characters has been set up for patient ID entry Section 3 2 2 2 the patient ID entered must meet the required minimum e Press and enter a patient ID with the required number of characters 8 5 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 2 System Error Messages Maximum Users Exceeded ERROR Bad Sensors Discard Cassette ERROR Possible Clot Discard Cassette B Lac Setup ERROR B Lac setup failed B Lac Setup ERROR Wrong Different Lot 8 6 lt Maximum Users Exceeded gt The number of user IDs stored in memory has reached 300 e Press to continue e Delete unused user IDs from memory See Section 3 2 3 1 2 lt ERROR Bad Sensors gt Two or more measured parameter sensors are bad e Press a discard the cassette and repeat the test with a new cassette lt ERROR Possible Clot gt A sample error has occurred This may be due to a clot or blockage preventing sample aspiration e Press and discard casse
37. is calculated with PO 90 mmHg Operator s Manual OPTI CCA TS2 APPENDIX A TECHNICAL SPECIFICATIONS If measured O Hb and tHb are not available and calculated SO is enabled tO 1 39 50 Hb 0 00314 PO 100 vol 7 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 blood 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 TS2 allows for the estimation of P50 from measured SO PO and pH If a measured SO is not available the P50 value may be input via keypad For Adult hemoglobin e 26 7 10 gP02 1eP0 where ppo eee IM 29 SO H 100 50 mmHg For Fetal hemoglobin P 25 0 10ler0 1er0r where le PO _ lg 0 4 113 2 9 SO H 100 50 mmHg Operator s Manual OPTI CCA TS2 A 11 APPENDIX A TECHNICAL SPECIFICATIONS AaDO 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
38. lt A beep and a green status light indicates a valid bar code 3 3 3 CUSTOMIZATION Type Lot Number System gt Setup gt Control Expiration OPTICHECK Plus ol 2 pH PCO2 PO2 Na K CL Low 6 600 10 0 100 100 0 0 80 50 0 Kl Ranges 1 Ranges 2 a Lal LJ Lal a e KSE igh 70 200 0 ull Lo 180 0 t ss ui 1500 Ka Fig 3 9 Confirm Assay Ranges em 1 Ranges 2 Low High cars 020 E o cu 300 4000 BN 2s g 1120 Kl tec ox p Tests m so 250 gl soz soo 1000 Cancel Defaults Fig 3 10 Confirm Assay Ranges Scan Barcode B when prompted These two bar codes contain all necessary lot information for each level and may be confirmed in the subsequent screens When using OPTI CHECK PLUS scan Barcode C for the applicable level Confirm lot number expiration date and control type on the package insert supplied with the control material Fig 3 8 Ifthe bar code is unavailable press lt Manual Barcode gt and enter the control information manually Press the lt Ranges 1 gt tab to confirm the assay ranges on the package insert supplied with the control material Fig 3 9 Ifthe bar code is unavailable press the button and enter the numbers using the keypad Press lt Ranges 2 gt to go to the next display to enter the ranges for all other
39. lt All gt to select all results 9 Press lt Print gt to print your selection 10 Press K to return to the lt Data gt screen or to return to the main menu 6 4 Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT 6 1 4 Control Measurement Reports ECTS Ka T wm EEN The Data Manager menu allows you to Measurement Diagnostics print control measurement reports and statistical information Patient SRC You can print out individual control results groups SS San eler of control results or all the results in memory _ Storage Device In the default setting control reports are set to print automatically after each measurement Kl E QUSE Information on how to change these settings can be found in Section 3 2 4 1 LA ai 1 Inthe main menu select Data Manager 2 On the Measurement tab select Controls Fig 6 10 Fig 6 10 Select Controls Data Control Measurement 3 Inthe Data Control Measurement screen Fig 6 11 select a measurement and press the View button to display the measurement results Fig 6 12 4 Usethe Previous and Next Le buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 11 6 To print groups of results highlight the first measurement to be printed press Mark and select the last measurem
40. poz 1000 g oo gj oo m a EX CR Factors 1 Slope Offset Ca 1 000 0 00 wa a m BUN 1000 o gj a E Fig 3 42 Correlation Factors 2 Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION Correlation factors let you correlate results from your OPTI CCA TS2 to other analyzers Correlation factors are available for all measured parameters NOTE Slope is a multiplicative factor and Offset is an additive factor using the following formula Correlated value Raw value slope offset 1 Inthe main menu select lt System Manager gt and lt Setup gt 2 On the lt Patient QC gt tab press lt Correlation gt Fig 3 40 3 Select the numbers you want to change by pressing Fig 3 41 Enter the new numbers 4 Press lt Factors 2 gt to go to the next screen Fig 3 42 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 to accept the changes 8 Press Es to return to the lt Setup gt screen or to return to the main menu CAUTION Since altering the correlation factors will alter your measurement results be very careful to enter the correct values and confirm
41. where Art Arterial Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass 9 6 Operator s Manual OPTI CCA TS2 9 OPERATING PRINCIPLES Parameter Ranges Options Default Puncture Site Allen s Test Hemoglobin type Bypass O2 Mode Ventilator Mode 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 Unknown positive or negative Adult or fetal Off Pump On Pump 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 Other Other No SIMV PSV PCV CMV AC CPAP PCIVR or BIPAP 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 Operator s Manual OPTI CCA TS2 LR Unknown Adult Off Pump Rm Air 9 7 9 OPERATING PRINCIPLES Parameter Ranges Options Default Plateau Pressure Pplat 0 0 to 100 0 0 0 Minute Volume VE 0 to 120 0 Peak Inspiratory Pressure 0 to 140
42. 0 4 93 5 07 1 14 1 23 Fig 5 17 Calibration results Operator s Manual OPTI CCA TS2 5 SAMPLE HANDLING AND PATIENT TESTING The second tab displays the Calculated Results Fig 5 16 The third tab displays Calibration Results from the gas calibration preceding the measurement Fig 5 17 16 Open the cover and remove the cassette CAUTION When used the OPTI Cassette contains human body fluids and must be treated as medical waste Handle with appropriate care and dispose of in accordance with local regulations e f patient 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 10 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 2 4 2 e The OPTI CCA TS2 Analyzer indicates when values are above or below the programmed ranges with 1 UP 1 or DOWN arrow if they are outside the reference ranges or 2 arrows 11 L1 if they are outside the critical ranges Values outside the reference ranges appear amber and values outside the critical ranges appear red on the display If values are outside the measurable range a HIGH or LOW will be displa
43. 0 03 0 04 Total CV 1 0 0 6 0 6 K 2 Operator s Manual OPTI CCA TS2 ANALYTES POTASSIUM All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 measurement has been established against reference materials or methods Potassium linearity is established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions Potassium and by measurement of N I S T Standard Reference Material 956a Electrolytes in Human Serum 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 sr 0 9723 0 135 0 99956 0 05 2 0 6 0 18 Correlation to Other Methods OPTI CCA TS2 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 TS2 after obtaining the requisite results from existing instrumentation used
44. 1 From the Ready display select System Manager and Maintenance 2 Inthe Maintenance menu Fig 7 18 press Setup 3 Inthe Setup screen Fig 7 19 you can select the option Replace Pump Reminder The analyzer will then remind you when the next pump replacement is due 4 After you replace the peristaltic pump go to the Maintenance screen Fig 7 18 and press next to Pump Replacement The date of the last pump replacement will be displayed for future reference 7 7 7 MAINTENANCE 7 4 2 Replacing Gas I O Port 7 8 Fig 7 20 Gas I O Port To change the gas I O port l Open the SMC cover Remove the black I O port by grasping it with a hemostat or tweezers and firmly pulling upward Fig 7 20 Discard the old part Install the new gas I O port with the rounded surface pointing up and press it 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 8 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 TS2 7 5 As Needed Maintenance 7 5 1 Changing the Gas Bottle Not Ready Kl 17 47 04 Jan Not Ready Gas Not Installed New Gas Data Qc stem Manager Manager Manager Gas 0
45. 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 TS2 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 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 v
46. 17 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 The Standard Reference Cassette SRC Fig 1 18 is a reusable sensor cassette used for daily quality control testing The multi level SRC can be found in the storage compartment of your analyzer Each new analyzer comes with one multi level SRC that can test at 3 levels The SRC should be kept in its pouch when not in use see section 4 5 for instructions Operator s Manual OPTI CCA TS2 tHb Calibration Cassette Fig 1 19 tHb Calibration Cassette Gas Bottle Fig 1 20 Gas Bottle Congratulations 1 INTRODUCTION The reusable tHb Calibration Cassette Fig 1 19 is used for the quarterly calibration of the OPTI CCA TS2 Analyzer See Section 6 3 Quarterly Maintenance Performing tHb Calibration During calibration the OPTI CCA TS2 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 20 The TS2 will only work with gas bottles with a red base BP7162 You have just learned the basic components of the analyzer and are now ready to install your system Operator s Manual OPTI CCA TS2 1 9 2 SETUP 2 SETUP geet nn EE P 2 1 2 1 Important Safety Instructions cece ee eee eeeeeeeeeeeeeeeeesessesesseeeeeeeeeee
47. 2 1 1 Setting up the Quality Control Material 3 3 3 2 1 2 Selecting QC LOCKOUE iret io eed ea eod a td d va ed kd 3 5 3 2 2 Customizing Patient InrorffiatlOfla ecco eatenus robe utorrent nsn date mre tact paces Grm e 3 8 3 2 2 1 Setting up Patient Information sssssssssee enne 3 8 3 2 2 2 Suppressing Results for Measured Parameter 3 11 3 2 2 3 Setting up Calculated Parameters rre een 3 12 3 2 2 4 Setting up Limits for Measurement Parameters sss 3 13 3 2 2 5 Setting up Limits for Calculated Parameters sess 3 15 3 2 2 6 Setting up Test Panels ansehen nante n ca Ro nona cue ean Ra na 3 17 3 2 2 7 Setting Up Correlation Factors rec a Hk deca a 3 19 3 23 Seting UP SC UN EE 3 20 3 2 3 1 Selecting Security Settings nenne kenn 3 20 9 2 3 2 Setting Up a PassWOId unice a 3 26 3 2 3 3 System El IEN TEEN 3 27 Operator s Manual OPTI CCA TS2 TABLE OF CONTENTS 3 2 4 Miscellaneous System Settings an na ea 3 28 3 24 1 Setting El EE 3 28 3 2 4 2 Defining UniS EE 3 29 3 2 4 3 Selecting a language 3 31 3 2 4 4 Hardware Settings eii een een 3 32 3 2 4 5 Setting up Communtcatons ene nennen 3 35 3 2 4 6 Configuring Ethernet Gettngs iknin anina aE 3 38 3 2 5 Maintenance Setup desee tiia a nn 3 40 4 CALIBRATION AND QUALITY CONTROL eeeeeeeesss 4 1 41 Calibrati n mr ia 4 1 42 DC e E 4 2 4
48. 3 29 9 Press to accept the new limit values The instrument is preset to the measurement ranges ofthe OPTI CCA TS pH 6 600 7 800 PCO 10 0 200 0 mmHg EE 10 0 700 0 mmHg Na 100 0 180 0 mmol L Kt 0 80 9 99 mmol L CI 50 0 160 0 mmol L Ca 0 20 3 00 mmol L Glu 30 0 400 0 mg dL Glu 1 7 22 0 mmol L BUN 2 8 112 0 mg dL Urea 1 0 40 0 mmol L Lac 0 30 17 50 mmol L tHb 5 0 25 0 g dL SO 60 0 100 0 2 e Inall data input screens if values outside the acceptable input range are entered the system automatically flags the error and displays the valid range e The limits entered here will reside in the instrument memory even after system power is turned off 10 Press Ka to return to the lt Setup gt screen or FS to return to the main menu Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 2 2 5 Setting up Limits for Calculated Parameters This menu allows you to set up reference and critical measurement limits for all calculated parameters Ready Ki 11 17 10 Dec Patientiac Security System A result that is outside the limits you define here Een will be flagged with a single up arrow if above the Control Lockout oe e high reference limit or a single down arrow if below customizing Patient Information the low reference limit Results above or below the drot ween critical limits will be flagged with a double up or down arrow A message is included
49. 3 En ARC een 4 2 44 Calibration Venfication ee 4 3 45 QC Recommendations za in ann 4 3 4 5 1 Running an SRG Measurement sea rs pupUUR LS RUE MERE EES 4 4 452 R nga OG OS ie ea 4 8 4 5 2 1 Running Controls OPTI CHECK OPTI CHECK PLUS see 4 8 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling eee 5 1 SWEET 5 1 5 1 2 Sample Reouirements ENNEN 5 1 5 1 3 Anticoagulants and Sample Collection Devices eee 5 1 5 14 SYINGES e 5 2 S9 Capillary Eege ee ee 5 2 5 1 6 OPTI Medical ComfortSamplers M ssssesssssnesnnennnennnennnnnnennnnnnnennnn nn nn 5 2 5 1 7 Handling and Storage of Samples ann sein ae 5 3 5 1 8 Test Conditions ann 5 4 5 2 Sample Preparation iii neuen 5 4 5 2 1 Whole Blood Samples 5 4 5 9 Running A Patient Sample cierre etta Kaas een 5 5 6 DATA MANAGEMENT u 6 1 6 1 Printing Measurement and Statistics Reports 6 1 6 1 1 Patient Measurement Reports sssssssssssssssssssssseeeeeeeeeen enne 6 1 6 1 2 SRC Measurement HRepnorts ener nennen nennen nennen nnn 6 3 6 1 3 SRC Statistics Reports ccc cece cece cece cece cece cece cece cece eee cee eee eee eeeeseeeseeeeeeeeeeeeeeeeeeeeeees 6 4 6 1 4 Control Measurement HReports nn nn 6 5 6 1 5 Control Statistics
50. 737 7 Fig 2 25 Ready Screen 7 The Ready Display The lt Ready gt display Fig 2 25 appears when the analyzer is ready for operation and also displays important status information such as e lt Gas gt Displays the percentage of gas remaining e Baro Displays the current barometric pressure The lt Ready gt display also provides access to the following system functions e Data Manager This menu allows you to print out patient control and diagnostic information It also provides you with the ability to import export data For more information on printing and importing exporting data see Chapter 6 Data Management e QC Manager This menu allows you to perform control measurements For more information see Chapter 4 Calibration and Quality Control e System Manager This menu contains the following settings and functions Time and Date Chapter 3 1 Setup Chapter 3 2 Maintenance Chapter 3 2 5 and 7 1 Diagnostics Chapter 8 2 Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 CUSTOMIZATION u eek 3 1 4 1 Setting Time and Date eene rentre eee 3 1 E Bape eee ne M E 3 2 32 1 QC SetuP T 3 3 3 2 1 1 Setting up the Quality Control Material 3 3 3 2 1 2 Selecting ele EE 3 5 32 2 Customizing Patient ee EE 3 8 3 2 2 1 Setting up Patient Information nn 3 8 3 2 2 2 Suppressing Results for
51. Administration HCFA and the Clinical and Laboratory Standards Institute CLSI formerly NCCLS have published standards for quality assurance in medical laboratories Operator s Manual OPTI CCA TS2 4 4 4 5 4 CALIBRATION AND QUALITY CONTROL 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 TS2 Analyte Section included in the back section of this manual provides precision 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 QC Recommendations The multi level Standard Reference Cassette SRC should be used as a control for the OPTI CCA TS2 analyzer The SRC contains a stable optical sensor simulator which is measured by the device in exactly the same manner as any other cassette and provides assurance that all parameters measured by the analyzer are consistent The OPTI will subject the SRC sensors to different levels of light to simulate low normal and high patient measurements Level 1 and level 3 represent high and lo
52. B 4 Operator s Manual OPTI CCA TS2 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 behind 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 TS2 incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS2 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
53. Calibrator Cassette BP7653 Printer Paper HP0070 The OPTI CCA TS2 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 TS2 9 5 9 OPERATING PRINCIPLES 9 5 2 Test Conditions Sample Size Sample Type Sample Application Ambient Temperature Relative Humidity Type of Measurement 9 5 3 Input Values a minimum of 125 uL 60uL for B60 cassette heparinized whole blood serum and plasma syringe capillary or ComfortSampler 10 30 C 50 86 F 5 to 95 non condensing optical fluorescence pH PO PCO Na K Ca CT Glu BUN urea Lac and reflectance tHb SO Parameter Ranges Options Default Patient ID 25 alphanumeric characters Blank Accession Number 25 alphanumeric characters Blank Date of Birth Month DD YYYY Patient Sex Male female or unknown unknown Patient temperature T 14 0 to 44 0 C 37 0 C 57 2 to 111 2 F 98 6 F Medical Record Number 25 alphanumeric characters Blank Account Number 25 alphanumeric characters Blank Test ID 25 alphanumeric characters Blank Patient Name 25 alphanumeric characters Blank Age 1 150 0 Attending Physician 25 alphanumeric characters Blank Patient Location 25 alphanumeric characters Blank Sample Collection Time Month DD YY HH MM Blank Sample Type Art Ven MixVen Cap Art Cord CPB
54. Cassette Type B 60 E CI Enable BE Iv mem O2 c tco2 v E aD02 Hoos V E Bun za TI BB a E Glu 50 c BEact B Lac BEect Hec v cancel Defeuts B sae Lt Fig 3 23 Select Parameters 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 1 Inthe main menu select System Manager and lt Setup gt 2 On the lt Patient QC gt tab press Calculated Parameters gt Fig 3 22 3 Select the cassette type Fig 3 23 4 Select the parameters to be printed 5 Press to accept the changes 6 Press Es to return to the lt Setup gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 2 24 Setting up Limits for Measurement Parameters This menu allows you to set up reference and critical Ready W 11 17 _ 10 Dec measurement limits for all measured parameters Erbe Security Syste m A result that is outside the limits you define here Control Lockout will be flagged with a single up arrow if above the high reference limit or a single down arrow if below Customizing Patient Information 1 a Meee the low reference limit Results above or below the
55. Chloride 1 0064 244 0 99823 1 66 74 142 16 Cl 2 Operator s Manual OPTI CCA TS2 ANALYTES CHLORIDE Correlation to Other Methods OPTI CCA TS2 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 TS2 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 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 TS2 CI 3 ANALYTES GLUCOSE Glucose Glu Clinical Significance Glucose is the primary energy source of the body with the brain and erythrocytes being totally
56. Close Printer Cover 7 5 3 Performing Routine Cleaning Operator s Manual OPTI CCA TS2 7 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 1 Press the red printer release button on the printer cover to acces the printer Fig 7 28 2 Place the roll of printer paper into the paper tray 3 Pull the end of the paper upward and slightly out of the paper tray Fig 7 29 4 Hold the paper and close the printer cover Fig 7 30 e The paper will automatically feed through as the printer starts printing The OPTI CCA TS2 Analyzer is designed to require very little maintenance Routine cleaning consists of wiping the exterior analyzer surfaces including touch screen with a soft damp cloth NOTE Never use strong or abrasive cleaners on the OPTI CCA TS2 analyzer NOTE Do not spray cleaning spray directly on to the screen 7 11 8 DIAGNOSTICS AND TROUBLESHOOTING 8 DIAGNOSTICS AND TROUBLESHOOTING urssrunnnnnnnnnnnnnnnnnnnn 8 1 8 1 System Error and Warning Messages eese 8 1 8 1 1 System Warning Messagas nn een 8 2 8 12 System ege e 8 6 8 1 3 System Stop Messages EE 8 12 8 1 4 Not Ready Messages E 8 13 9 19 Fatal Eror Messages 2 u 8 16 92 Diagnosiies anne een 8 18 8 2 1 Checking VersSi N aeg 8 18 8 2 2 Checking System NR nt een ende 8 19 8 2 3 Checking
57. Controls Storage Device Miscellaneous Reports Configuration Maintenance Lt Fig 6 5 Select SRC Data gt SRC Measurement IE ale aL Lic e Fig 6 6 SRC Measurements Data gt SRC Measurement gt View Ready Y 21 32 10 Dec Fig 6 7 View SRC Results Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT The lt Data Manager gt menu allows you to print out SRC reports and statistical information You can print out individual SRC results groups of SRC results or all the results in memory In the default setting SRC reports are set to print automatically after each measurement Information on how to change these settings can be found in Section 3 2 4 1 1 To print an SRC report select Data Manager in the main menu 2 On the lt Measurement gt tab select lt SRC gt Fig 6 5 3 Inthe Data SRC Measurement gt screen Fig 6 6 select a measurement and press the lt View gt button to display the measurement results Fig 6 7 4 Use the lt Previous gt and lt Next gt Lal buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 6 6 To print groups of results highlight the first measurement to be printed press lt Mark gt e and select the last measurement to be printed All the measurements in between will be
58. Exp Date MMM YYYY 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 F5 0 000 0 000 G1 1 062 G2 1 087 G3 1 082 Fig 2 23 HbCal Report Ready Ki 17 53 04 Jan Scan Cassette Barcode Manual Entry Last Entry Data Qc System Manager Manager Manager Gas 99 Baro 737 7 Fig 2 24 Ready Screen Operator s Manual OPTI CCA TS2 2 SETUP The unit will now begin printing the Hb Calibration Report showing calibration results and calibration factors Fig 2 23 Once the Hb Calibration is complete the Ready display will appear Fig 2 24 and the analyzer is ready for operation OPTI Medical recommends that you run controls prior to running patient samples on a new analyzer You must set up your OPTI Check control lot information in your new analyzer prior to running them SRCs do not require setup and can be found in the storage compartment in the back of your analyzer Refer to section 3 2 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 2 9 2 SETUP 2 10 Ready Ki 17 53 04 Jan Scan Cassette Barcode Manual Entry Last Entry Data Qc System Manager Manager a Gas 99 Baro
59. 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 TS2 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 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 a
60. Kt 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 hypokalemia 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 potassium 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 ele
61. OPTI CCA TS2 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 TS2 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 TS2 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
62. Parameters Parameters critical limits will be flagged with a double up or down arrow A message is included on the printout explaining each arrow 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 Inthe main menu select System Manager and lt Setup gt 2 On the lt Patient QC gt tab press lt Measurement Limits gt Fig 3 24 Reference Enable iv Low igh am Pco2 30 g soo gg poz 700 gj 700 i u mol eig 4 Back Page 1 of 3 3 On the Reference tab Fig 3 25 select the parameter you want to change and press to enter the new limit value By default reference ranges are enabled 4 Press to access pages 2 and 3 with the remaining parameters Fig 3 26 5 Press to accept the new limit value The instrument is preset to the following reference Fig 3 25 Reference Limits ranges Sys gt Setup gt Measurement Limits pH 7 200 u 7 600 Not Ready 11 34 10 Dec PCO 30 0 50 0 mmHg pre tta PO 70 0 700 0 mmHg Low Ig Na 135 0 145 0 mmol L Se s1 e Uer 3 50 5 10 mmol L c oso kl veo k Cr 95 0 115 0 mmol L Car 1 ve K i Ca 1 13 1 32 mmol L Gu eo A 2 k Glu 60 0 120 0 mg dL BUN 59 k l 19 9 k l Glu 3 3 6 6 mmol L Back Page 2of3 BUN 5 9
63. QC Lockout Enable Vv Lockout By Level Enable O By Level By Number 1 2 3 1 2 vw Ww o ee og r Interval 8hr 12hr 24hr 7dy 1 e C C C Lg LS Ol Fig 3 13 QC Lockout 3 6 When this option is enabled external QC measurements must be performed at specified intervals for patient measurements to be allowed 1 To specify the number of QC measurements to be performed make sure lt Lockout By Level Enable gt is not selected and select 1 2 or 3 in the lt By Number gt option To specify the levels to run select lt Lockout By Level Enable and the levels to run in the lt By Level gt option Define the time interval during which QC measurements must be run Options are 8 12 24 hours 7 days and month By default the analyzer is set to run 3 levels of external controls at 1 month intervals To disable QC lockouts deselect QC Lockout Enable gt Press to accept the changes NOTE The selected time interval starts with the time this feature is activated 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 NOTE 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 Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION
64. Reports 2 2 0 cece cece cee cee cece cece eeeeeeeee cece ee cee eeee eee eeeeseeeeeeeeeeeseeeeeeeeeeeeeees 6 6 Il Operator s Manual OPTI CCA TS2 TABLE OF CONTENTS 6 2 Printing Diagnostics Reports 2 nee 6 7 6 2 1 Patient Diagnostics Repars a a OR MU UI ERN ri 6 7 6 2 2 SRC Diagnostics NODDITS nannte a puli 6 8 5 2 3 Controls Diagnostics IRE EE 6 9 6 2 4 Error Report 6 10 6 3 Miscellaneous Reparls essen 6 11 6 3 1 Maintenance Report 6 11 64 ImportinglExportng Data 6 12 6 4 1 Exporting Measurement Dalee ede een kennen 6 12 6 4 2 Exporting Configuration Data ee 6 14 643 Exporting the Database asien 6 15 MEC gu Np nnna 7 1 1 4 Daily CInn rg pcne 7 1 7 2 Weekly lop n c 7 1 7 3 Quarterly Maintenance Performing tHb Calibration 7 2 1 4 E et CET 7 6 1 4 1 Replacing Pen Pump Cartridge css a a ea 7 6 242 Replacing Gas WO Pi ac en 7 8 7 5 As Needed Maintenance u 7 9 2 5 1 Changing the Gas LEE 7 9 7 32 Changing the NEE 7 11 7 5 3 Performing Routine ClO Te EE 7 11 8 DIAGNOSTICS AND TROUBLESHOOTING uursssunnnnnnnnnnnnnnnnnnnnn 8 1 8 1 System Error and Warning Messages eene 8 1 98 1 1 System Warning WSS SA SS ceased caged eii ei 8 2 8 1 2 System Error MESSAD E 8 6 8 1 3 System Stop E GE 8 12 8 1 4 Not Ready MESSAJES m 8 13 8 19 Fatal Error Messages
65. Sex Male FIO2 0 21 Temperature 37 0 C MCHC 333 Patient First Name JOHN RQ 0 84 Patient Last Name P50 26 7 mmHg SMITH BiLevel 1 0 1 0 Attending Physician VE 1 0 1 0 DR JOHNSON Patient Location Barometer 739 6mm Hg ER Operator ID 123456789012 Sample Collection Time 12 Feb 13 11 26 Lot 250100 Age 28 S N 0 Sample Type Art Version 1 000037 PuncSite LR Allen STest Negative REFERENCE RANGES tHb Type Adult pH 7 200 7 600 Bypass off pump PCO2 30 0 50 0 mmHg 02 Mode RmAir P02 70 0 700 0 mmHg Memo Ng tHb 120 170 g dL S02 90 0 100 0 Sample No 291 MESSAGES iiir 7143 pH under 7 200 Ref Lim i PCO2 over 50 0 Ref Lim PCO2 T 76 0 mmHg P02 74 5 mmHg tHb Result suppressed BE 60 mmol L S02 Result suppressed tC02 27 3 mmol L HCO3 T 249 mmol L Operator s Manual OPTI CCA TS2 D 1 APPENDIX D REPORT FORMATS SRC Measurement Report E Ca example D 2 De OPTIMedical OPTI CCA TS2 SRC Measurement DD MMM YY HH MM S N 123 Version 1 23 4567 Level 3 SRCID 12345678 Exp MMMYYYY Result Limits pH 7 601 7 580 7 620 PCO2 20 0 18 0 22 0 PO2 170 0 167 0 173 0 Na 65 1 42 148 K 7 00 6 70 7 30 Ca 0 70 0 60 0 80 tHb 8 5 6 5 9 5 02 98 6 96 0 100 0 SRC Test Result PASS Operator ID Operator123 OK OK OK OK OK OK OK OK OK Operator s Manual OPTI CCA TS2 APPENDIX D REPORT FORMATS SRC Statistics Report MN HEMOGLOBIN LIMITS
66. 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 Henry 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 mmol 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 TS2 A 5 APPENDIX A TECHNICAL SPECIFICATIONS Data Management Printout Built in thermoprinter Communication 1 x USB Type A port 1x USB Type B port 1 x Ethernet port Format ASCII ASTM POCTI and CSV Storage Data storage on the OPTI CCA TS2 is dynamic Storage capacity is up to 500 patient records QC data for 1 month at 3 levels SRC data for 1 month at 3 leve
67. Values LOW NORMAL HIGH Units 70 0 2 40 0 2 20 0 x2 mmHg Operator s Manual OPTI CCA TS2 PCO2 1 PCO ANALYTES Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below PCO mmHg OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 74 5 45 0 24 8 Within Run St Dev S 0 8 0 3 0 3 Within Run CV 1 1 0 7 1 1 Total Precision St Dev S 0 9 0 5 0 4 Total CV 1 3 1 0 1 5 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 systems All values are in mmHg PCO2 2 Expected n Observed Swr bias Recovery 10 4 9 10 9 0 28 0 5 1
68. a traditional blood gas clinical laboratory setting or point of care locations by personnel minimally qualified to perform and report these results The table below 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 x mmHg kPa 10 200 1 0 1 PO x 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 x x x 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 x g dL mmol L g L 5 25 0 1 SO D K 60 100 1 0 1 Principles of Operation The OPTI CCA TS2 is a microprocessor controlled medical instrument measuring optical fluorescence from discrete sensors called optical electrodes optodes A disposable single use cassette contains all ofthe 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
69. and calibration information for the specif c cassette Fig 4 15 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 confrm 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 4 9 4 CALIBRATION AND QUALITY CONTROL 5 Open the sample chamber cover by pressing down on the red latch Fig 4 16 6 Tear open the cassette pouch and remove the Open nn Wipe cassette 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 7 Insert the cassette into the chamber Press down to ensure that the cassette is seated properly Fig 4 17 NOTE Run cassettes immediately after opening pouch Do not run if cassette has been out of pouch for more than 2 minutes 8 Close the SMC cover Fig 4 18 Fig 4 18 Close Cover 4 10 Operator s Manual OPTI CCA TS2 Messuing W 1319 10 Dec
70. 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 9 5 Procedure 9 5 1 Materials Needed Description Part Number Sensor Cassettes see Chapter 10 Supplies in various analyte configurations Multi Level Standard Reference Cassette BP7652 Calibration Gas Bottle BP7162 Hb
71. button eu to display the measurement results Fig 6 17 4 Use the lt Previous gt and lt Next gt buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 16 6 To print groups of results highlight the first measurement to be printed press lt Mark gt e and select the last measurement to be printed All the measurements in between will be selected 7 Press All to select all results 8 Press Print to print your selection 9 Press to return to the Data screen or to return to the main menu 6 7 6 DATA MANAGEMENT 6 2 2 SRC Diagnostics Reports Measurement Diagnostics Patient SR Controls Errors Database EN Fig 6 18 Select SRC B 3 SE mE E 3 3 10 Dec 12 Fig 6 19 Select Measurement Data gt SRC Diagnostics gt View Ready 21 49 10 Dec 2126970 0 04 0 003 2107580 0 00 0 002 2063610 0 03 0 003 2413080 0 01 0 004 3661260 0 03 0 003 4570930 0 02 0 002 Fig 6 20 SRC Diagnostics 6 8 The lt SRC Diagnostics Report gt contains information about the measured signal in femtowatts and drifts observed during measurement You can print out reports of individual SRC measurements groups of SRC measurements or all the measurements in memory 1 To print an SRC Diagnostics Report select lt Data Manager
72. familiarize yourself with the analyzer s components Printer Printer Release SUUS Button Touch Screen Display KC Ka Sample Measurement gt Chamber SMC j __ Status Light SMC Latch Gas Bottle Bar Code Scanner Power Connector Battery uu Handle Tilt Stand Fig 1 1 OPTI CCA TS2 Major Components N On Off Button Operator s Manual OPTI CCA TS2 1 3 1 INTRODUCTION Touch Screen i Fig 1 2 Touch Screen Status Light N r 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 Fig 1 2 displaying the activities of the analyzer sample results and other relevant information You communicate with the analyzer through a graphical user interface which is used to perform all analyzer functions 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 The system is running a measurement and waiting for user action e Blinking Green Light System is in process of calibration or measurement Do not open the cover e Red Light A red status light indicates an error that will terminate the process 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
73. female Temperature default value 37 0 C Operator s Manual OPTI CCA TS2 System gt Setup gt Patient Information Ready E 11 20 10 Dec Available Functions Medical Record Number x Account Number Test ID Patient Name Selected Functions Required rE Accession Number Li DOB m Sex m D A Cancel Defauts Save ES Fig 3 18 Patient Information Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION Scroll down for the following additional options Fig 3 18 e Medical Record Number 25 alphanumeric characters e Account No 25 alphanumeric characters e Test ID 25 alphanumeric characters e Patient Name 25 alphanumeric characters e Age 0 150 e Attending Physician 25 alphanumeric characters e Patient Location 25 alphanumeric characters e Sample Collection Time Month DD YYYY HH MM e Sample Type Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass e Puncture Site 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 e Allen s Test unknown positive or negative e tHb Type adult or fetal default is adult e Bypass pump off or on e O2 Mode Rm Air Mask T P NC Vent Bag Hood Other where RmAir Room Air Mask
74. 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 0 019 0 087 x 0 077 0 9830 0 197 2 3 9 4 105 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 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 TS2 K 3 ANALYTES CALCIUM lonized Calcium Ca Clinical Significance Calcium in blood is distributed as free calcium ions 50 bound to protein mostly albumin 40 and 1096 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 c
75. gt Security Not Ready Settings Users ame Groups EEE 31 Jan 14 E 31 Jan 14 ADMIN PEE u KO Fig 3 52 Users Operator s Manual OPTI CCA TS2 10 11 12 3 CUSTOMIZATION In the lt User Information gt screen Fig 3 51 press to enter the user ID up to 25 characters If lt Expiration gt is selected in the setup menu enter an expiration date for the user ID You can add the user to pre configured lt Groups gt at this time or you can do this later once custom groups have been created see Section 3 2 3 1 3 The first time users log in to the OPTI they will be asked to create a password To edit an existing user select the user Fig 3 52 and press Kl to make the changes Press lt Reset Password gt Fig 3 51 to reset the user s password To delete a user from the list of valid users currently stored in memory select the user and press the button Press i to select all entries Press the button to print the list of all users currently stored in memory Use the lt Previous gt Lal and lt Next gt Lol buttons to display the previous or next page of user IDs 3 23 3 CUSTOMIZATION 3 2 3 1 3 Setting up User Groups 3 24 System gt Setup gt Security Not Ready Ki 11 47 Settings ml Users ADMIN Users 5678 Fig 3 53 Groups Group Information Name recu 1 E D Cancel OK Fig 3 54 Enter Group Name
76. iata uis nen 8 16 CPUMMEND I n ld eet ee 8 18 92 1 Checking Versi ns me T 8 18 8 2 2 Checking System Temperatur euer st M mA 8 19 8 2 3 Checking Gas PESUR E 8 19 82 4 Checking the RE 8 20 822 Vernfying Barometre TE 8 20 8 26 Checking the Battery Vollage ana ee a a a 8 21 92 7 Checking the Cooling Fan sarsicce sner esa nE a AAN AESA 8 21 Operator s Manual OPTI CCA TS2 II TABLE OF CONTENTS 82 8 Gh cking teas Yale aaa ee 8 22 8 2 20 Checking the Valve Diner een 8 22 8 2 10 Checking the Factory ee E E 8 23 8 2 11 Checking the Bar Code Seanner ae QRR RUE E dupE naiiai iini 8 23 8 2 12 Checking the ee P M rere ee 8 24 8 2 12 Ehecking RL 8 25 8 2 14 Checking the Ethernet Interface eese eene nnns 8 26 8 2 19 Checking the Pump Flow sk 8 27 8 2 15 Checking Ihe Pump Molo uu cedrus seen 8 28 82 12 Checking ATS AY ee ee een 8 28 8 2 18 Checking the Touch Rm 8 29 8 2 19 Gas TeSt iiras Re AE AEREE 8 30 8 2 20 Setting up the Blase Cassette E 8 31 8 2 21 Cassette DEI u a nenne ee 8 33 8 3 VE Te S t 8 34 8 3 1 Troubleshooting Procedure Tor HIBIS auscssexinisgenicudebad cusan xtd tni ud ab Sou riti ap 8 34 8 3 2 Troubleshooting Procedure for Bar Code Gcanmer nenn 8 35 9 OPERATING PRINCIPLES u na a a Sac RU dE dcs 9 1 NEE 0 0o cv Pee ner MM 9 1 92 Pnnciples OF Procedure iia See gegiesets nuo tutta ge nennen euren 9 1 9
77. 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 9 2 Operator s Manual OPTI CCA TS2 9 OPERATING PRINCIPLES 9 4 Specimen Collection and Handling 9 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 9 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 sample handling documentation and specific procedures used approved by the personnel responsible 9 4 3 Anticoagulants and Sample Collection Devices Lithium heparin
78. 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 TS2 incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS2 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 3 0 1 0 01 kPa Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 60 0 3 100 0 3 170 0 x 3 mmHg 8 00 0 40 13 33 0 40 22 66 0 40 kPa Operator s Manual OPTI CCA TS2 PO2 B 1 PO 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 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 m
79. 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 9 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 affects the measurement of total hemoglobin 9 4 5 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume
80. it into the SMC e Ifthe message still appears with a different cassette turn the power off and back on and retry lt ERROR Cassette Misseat 2 gt The cassette was not properly placed into the chamber or it was previously used e Press Is discard the cassette and repeat test with a new cassette e Ifthe message still appears with a different cassette turn the power off and back on and retry lt ERROR Bad Cassette gt The cassette or its packaging is defective e Press Low 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 with a different cassette turn the power off and back on and retry 8 7 8 DIAGNOSTICS AND TROUBLESHOOTING ERROR Bad Calibration Discard Cassette Calibration ERROR Dirty Optics Discard Cassette Measurement ERROR Calibration Expired Discard Cassette ERROR Unstable Sensors Discard Cassette Aspiration ERROR Short Sample Discard Cassette 8 8 lt ERROR Bad Calibration gt The instrument did not calibrate due to problems with the cassette or instrument e Press 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 back on and retry lt ERROR Dirty Optics gt The analyzer is unable to calibrate the sample light gates due to d
81. lt Enable gt to enter critical limit values 6 Select the parameter you want to change and press Kl to enter the new value 7 Press to access pages 2 3 and 4 with the remaining parameters Figs 3 34 and 3 35 and press to accept the new values The instrument is preset to the measurement ranges ofthe TS2 HCO3 1 0 200 0 mmol L BE 40 0 40 0 mmol L BE 40 0 40 0 mmol L BE 40 0 40 0 mmol L BB 0 0 100 0 mmol L tCO2 1 0 200 0 mmol L st HCO3 1 0 200 0 mmol L st pH 6 500 8 000 SO2 c 0 0 100 0 O2ct 0 0 56 0 mL dL Het c 15 0 75 0 cH 10 0 1000 0 nmol L AaDO2 0 0 800 0 mmHg AnGap 3 0 30 0 mmol L P50 15 0 35 0 mmHg nCa 0 10 3 00 mmol L e Jnall data input screens if values outside the acceptable input range are entered the system automatically flags the error and displays the valid range e The limits entered here will reside in the instrument memory even after system power is turned off 8 Press i to return to the Setup screen or to return to the main menu Operator s Manual OPTI CCA TS2 3 2 2 6 Setting up Test Panels Ready Ki 11 17 10 Dec Patient QC Security System ac Control Lockout gt Customizing Patient Information Patient Measured Calculated Entry Parameters Parameters Measurement Calculated Limits Limits N mint Panel Correlation u KO Fig 3 36 P
82. materials may interfere with the pH measurement or fail to be properly aspirated Reproducibility Within run precision S and Total Precision S 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 3 different control levels are shown below Controls pH OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 7 151 7 415 7 624 Within Run St Dev S 0 003 0 006 0 005 Within Run 9o CV 0 0 0 1 0 1 Total Precision St Dev S 0 005 0 007 0 007 Total CV 0 1 0 1 0 1 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 ANALYTES pH Linearity Wherever possible linearity for the OPTI CCA TS2 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 OPT
83. measured parameters available with this control material Fig 3 10 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 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 TS2 3 2 1 2 Selecting QC Lockout Ready Ki 11 17 10 Dec Patient QC Security System ac pm Customizing Patient Information Patient Measured Calculate Entry Parameters Parameters Measurement Calculated Limits Limits Bene Correlation W KO Fig 3 11 QC Lockout System gt Setup gt Lockout Ready 12 20 10 Dec SRC ac New Lot SRC Lock able Iv Lockout By Level Enable m r By Level By Number 1 2 3 1 2 3 k TR o e Interval Bhr 12hr 7dy C Ze 9m K Fig 3 12 SRC Lockout Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION This menu can be used to lock out operators unless some form of QC is peformed OPTI Medical recommends using each option described below Each facility shoul
84. on the OPTI CCA TS2 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 TS2 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 ofpH 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 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
85. on the printout Cera explaining each arrow 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 Fig 3 30 Calculated Limits accordingly 1 Inthe main menu select lt System Manager gt and lt Setup gt Press lt Calculated Limits gt on the lt Patient QC gt tab Fig 3 30 2 On the lt Reference gt tab Fig 3 31 select the parameter you want to change and press to enter the new limit value By default reference ranges are enabled 3 Press net s i to access Pages 2 3 and 4 with the remaining parameters Fig 3 32 4 Press to accept the new limit value The instrument is preset to the following reference Sys gt Setup gt Calculated Limits Not Ready Ki 11 35 10 Dec Reference Critical Enable Iv Low High Hco3 Ten y 220 kal tw BEect 2 30 gj Beact 20 i s k Back Page 1 of 4 Kata ranges Fig 3 31 Reference Limits HCO3 18 0 23 0 mmol L BE 2 0 3 0 mmol L Sys gt Setup gt Calculated Limits BE 2 0 3 0 mmol L SE BE 2 0 3 0 mmol L E BB 46 0 52 0 mmol L Low High EET LM tCO2 220 290 mmol L st HCO3 22 0 24 0 mmol L tco2 220 gg Tan ka st pH 7 350 7 450 E E SO2 c 95 0 98 0 son 72 ei O2ct 15 0 23 0 mL dL sore oso i Het c 34 0 51 0
86. operated at normal room temperature 20 C 5 C Retain the original product literature for future reference Use cell and battery only in the application for which it was intended When possible remove the battery from the equipment when not in use Dispose of cells and batteries properly Operating Safety Information Symbol Definitions The symbols described below are used on the packaging of OPTI CCA TS2 related products Symbol m gt lt gt x EA LOT gt 69 PFTG gt Explanation 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 identified with
87. the desired levels Fig 4 4 and press Select SRC Level s to Run 1 2 3 M M M l n kenen Fig 4 4 Select Level Measuring Open Cover 5 Open the sample chamber cover by pressing down on the red latch Fig 4 5 Fig 4 5 Open Cover Measuring Insert Cassette u 6 Examine the SRC to ensure it is clean and insert it into the chamber Press down to properly seat the SRC Fig 4 6 Fig 4 6 Insert SRC Operator s Manual OPTI CCA TS2 4 5 4 CALIBRATION AND QUALITY CONTROL Measuring Close Cover Fig 4 7 Close Cover Measuring SRC Measurement In Progress Please Wait Measuring ENN 24 Fig 4 8 SRC Measurement QC gt SRC gt Results Measuring KE 13 12 10 Dec Level1 Level 3 Pass Para ae Result Limits Fail meter pH 7 100 7 080 7 120 C 70 0 68 0 72 0 60 0 57 0 63 0 125 0 123 0 127 0 2 50 2 20 2 80 Cl 80 0 78 0 82 0 Ca 1 80 1 70 1 90 Page 1 of 2 Ji Fig 4 9 SRC Results 1 4 6 7 Close the sample chamber cover Fig 4 7 e After the cover has been closed the instrument begins the measurement process which is indicated on the display screen Fig 4 8 During this time about 60 seconds per level a progress bar is displayed e When the measurement is complete the unit displays the results Fig 4 9 8 Press ETE to display additional results Fig 4 10 Operator s M
88. the settings by running at least 10 comparison measurements between the OPTI CCA TS2 and the instrument to which it is to be correlated 3 19 3 CUSTOMIZATION 3 2 3 Setting up Security System gt Setup 3 2 3 1 3 20 Ready Ki 01 56 19 Dec Patient QC Security system Change Password setae K K Fig 3 43 Security Selecting Security Settings Ready o 01 56 19 Dec Patient QC Security System Change Password User ID ADMIN Password Fig 3 45 Login The OPTI CCA TS2 has three types of security options Fig 3 43 lt Settings gt Use this option to set up various security settings including User IDs and User Groups See section 3 2 3 1 lt Change Password gt Use this option to change your password while you are logged on See section 3 2 3 2 lt Reinitialize gt Use this option to delete the database and return to the system default settings See section 3 2 3 3 To access this menu select lt System Manager gt and Setup in the main menu In the lt System Setup gt screen press the lt Security gt tab Fig 3 43 The lt Settings gt menu contains three screens lt Settings gt with various security options lt Users gt to set up User IDs lt Groups gt to set up User Groups Select System Manager and Setup in the main menu On the Security tab in the Setup menu press Settings
89. 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 ce REF il 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 TS2 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 KL ionized calcium Ca chloride Cl 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 setting up your
90. 0 PIP Flow Rate Liter Flow FR 0 00 to 300 00 0 00 Tidal Volume VT 0 to 4000 0 Pressure Support Value PS 0 0 to 99 9 0 0 Positive End Expiratory 0 to 50 0 Pressure PEEP Rate f 0 to 155 bpm 0 Continuous Positive Airway 0 to 50 0 Pressure CPAP Total hemoglobin tHb 1 0 to 26 0 g dL 15 0 g dL 0 62 to 16 14 mmol L 9 31 mmol L 1 to 260 g L 150 g L FIO 0 21 to 1 0 0 21 Mean corpuscular hemoglobin 29 0 to 37 0 96 33 3 concentration MCHC Rrespiratory quotient RQ 0 70 to 2 00 0 84 Ps 15 0 to 40 0 mmHg 26 7 mmHg 2 0 to 5 33 kPa 3 56 kPa Bi Level Pressure Numerator 0 2 9 9 1 0 Bi Level Pressure Denominator 0 2 9 9 1 0 I E Ratio Numerator 0 2 9 9 1 0 I E Ratio Denominator 0 2 9 9 1 0 Comment Field 50 alphanumeric characters Blank 9 8 Operator s Manual OPTI CCA TS2 9 OPERATING PRINCIPLES 9 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 arter
91. 0 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 Conditions of Acceptability Coin cell battery on main board e Overcharging short circuiting reverse charging mutilation or incineration of the cells must be avoided to prevent one or more of the following occurrences release of toxic materials release of hydrogen and or oxygen gas rise in surface temperature If a cell has leaked or vented it should be replaced immediately using protective gloves If and when necessary these cells must be replaced with identical new ones from the same manufacturer If a cell to be replaced is connected with other cells in series it is recommended that the other cells be replaced with new ones at the same time Reverse polarity installation of the cell in the end product must be avoided Operating Safety Information Operating Safety Information Recommendations for Usage and Storage of Lithium lon Battery Pack a Do not dismantle open or shred secondary cells or batteries Do not expose cells or batteries to heat or fire Avoid storage in direct sunlight Do not short circuit a cell or a battery Do not store cells or batteries haphazardly in a box or drawer where they may short circuit each other or be short circuited by other metal objects Do not r
92. 05 27 6 9 29 3 0 36 1 7 106 27 8 9 29 1 0 41 1 3 105 45 0 9 44 2 0 33 0 8 98 60 6 9 60 3 0 55 0 3 100 69 2 9 69 4 0 55 0 2 100 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 Operator s Manual OPTI CCA TS2 ANALYTES PCO Linearity Wherever possible linearity for the OPTI CCA TS2 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 TS2 systems Correlation Slope Intercept Coefficient Sy x Range n 0 9681 2 148 0 99967 1 53 11 201 81 Correlation to Other Methods OPTI CCA TS2 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 TS2 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 02
93. 2 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 whole blood Analyzer E 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 TS2 PCO2 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
94. 2 3 reference intervals PCO2 1 references PCO2 3 reproducibility PCO2 1 SRC limit values PCO2 1 temperature corrected A 12 Carrying handle 1 7 Operator s Manual OPTI CCA TS2 INDEX Cassette calibrator description 8 15 Chloride CI Clinical significance CL Correlation to Other Methods Cl 3 Interferences Cl 2 Linearity Cl 2 Measurement principle Cl 1 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 setting up 3 33 Configuration report 7 35 Consumable items 9 2 Control Reports printing 4 15 Conversion units A 8 Cooling fan checking 7 17 Correlation factors setting up 3 18 Critical ranges 3 12 Customization 3 1 D Data export 4 16 management A 6 patient 5 9 Date setting 2 3 Diagnostic reports control 7 32 patient 7 30 SRC 7 31 Diagnostics 7 1 7 14 Dimensions and weight A 6 Display test 7 24 INDEX E Error displays 7 1 Error report 7 33 7 34 Ethernet settings 3 36 Expiration setting up 3 21 Export data 4 16 F Factory settings checking 7 19 G Gas bottle changing 6 7 description 1 9 installing 2 4 Gas I O Port replacing 6 6 Gas pressure checking 7 15 Gas test 7 26 Gas valve checking 7 18 Glucose Glu Clinical significance Glu 1 Correlation to Other Methods Glu 4 Interferences Glu 2 Linearity Glu 3 Measurement principle Glu 2 Measurement range Glu 2 Re
95. 3 Anticoagulants and Sample Collection Devices eeeceesesseeeeeeeeeeen 9 3 IA Sy Lo RETURN eee ee 9 3 9 45 Capillary WUDSS cem nee 9 3 9 4 6 OPTI Medical ComfortSamplers M nsssssssssnnennnennnennnennnennnnnnnnnn nn nsn nn nn 9 4 9 4 7 Handling and Storage Of Samples a Lu 9 4 CE SE Sec 7 nennen 9 5 9 5 1 Materials Needed inten ep rui Rd Ru ERR Ru d Fu RR RA E RE RR i Ru a in 9 5 9 32 est COMMONS coepi troc erede eva deer he de eve hand netted vera due vedou du Re Ded ren 9 6 9 5 3 Input Values zer an 9 6 9 5 4 Calculated Values nennen nenne eene enn nenne enne e nennen 9 9 9 55 CalibratiOn irri aan ae 9 9 95 5 Quahty Cl rennen a idee Rap LE N 9 10 95 7 Reference Intervalsi ssec tha me dena at datareader ra Fax QE RE DV Te XL FRA Ta Ra Yd 9 11 9 5 8 Specific Performance Characherisice nennen nenne 9 11 9 5 9 Limitations sedeo ek 9 12 EE Kate le 9 13 9 59 11 JACGESSOFIES u ae 9 14 Operator s Manual OPTI CCA TS2 9 i 9 OPERATING PRINCIPLES 9 OPERATING PRINCIPLES 9 1 Intended Use The OPTI CCA TS2 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 sam
96. 3 S 0 1 rc E 9 2 9 4 Specimen Collection and Handling eene 9 3 IA Eegeregie 9 3 9 4 2 Sample Requirements eee eene nne n nenne nennen 9 3 9 4 3 Anticoagulants and Sample Collection Devices eeeeeeneee nennen 9 3 OE BEC dI EE 9 3 9 4 5 Capillary ce eng 9 3 9 4 6 OPTI Medical ComfortSamplers M nsssssssssnnennnennnennnennnennnnnnnnnne nn 9 4 9 4 7 Handling and Storage of Samples nre pu tan n ERE apap oe pa Frau NE Ru UR RAE 9 4 95 PIOced le cc 9 5 9 5 1 Materials TE E BE 9 5 352 EE Ferienserie 9 6 G Wee UE 9 6 9 5 4 Calculated EE 9 9 9 5 5 Ballbration M a 9 9 950 Q alty e de EE 9 10 9 5 7 Reference Intervals t 9 11 9 5 8 Specific Performance Characherisice nennen nenne 9 11 Pc EE me 9 12 9 5 10 WE nr 9 13 12 1 ACCESSOTE S TTE 9 14 IV Operator s Manual OPTI CCA TS2 TABLE OF CONTENTS 10 SUPPLIES ze 2220022 10 1 db W E 10 1 10 2 ASS os cease we oe ese a eee ec 10 1 10 3 Contro lsiGal brators mE mm 10 1 10 4 Bonsumableltems u remis 10 2 10 5 Accessories nee 10 2 10 6 Li fT ae ee 10 2 LONE AL 1 RENE LIT UIT 10 3 10 8 Technical Assistanee nisse nee 10 3 10 9 Warranty Registration U S Market Only eese 10 4 ANALYTES PH nee ee pH 1 pH Dry Sensor B Lac Cassette
97. 52 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 TS2 9 15 10 SUPPLIES SU yd Fr wo zen ee ee ea 10 1 10 1 Analyzer anne 10 1 10 2 Cassettes oe nee ea een Eh 10 1 103 Controls Calibralors eine 10 1 10 4 Consumable dn e 10 2 30 9 EEN 10 2 10 6 Manuals pe 10 2 10 7 Spare Parts ae 10 3 10 8 Technical AssiSEalie oce core ror nn en nn nennnn enden 10 3 10 9 Warranty Registration U S Market Only eese 10 4 Operator s Manual OPTI CCA TS2 10 i 10 SUPPLIES 10 SUPPLIES Each OPTI CCA TS2 is shipped with maintenance supplies and other accessories 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 Entr
98. 6 DATA MANAGEMENT Data gt Patient Measurement Lil 08 Mar 13 08 Mar 13 08 Mar 13 j Fig 6 3 Patient Measurements Data gt Patient Measurement gt View Measured Calculated Calibration Measured Calculated TS Pass zz em me IS 7421 7 416 7 430 Pass Gesi ans 202 412 7 sos eas eno 000 Fig 6 4 Measurement Results 6 2 In the lt Data Patient Measurement gt screen Fig 6 3 select a measurement and press the lt View gt button ey to display the measurement results Fig 6 4 Use the lt Previous gt and lt Next gt Lel buttons to display the previous or next page of measurements To print individual results highlight the desired measurement Fig 6 3 To print groups of results highlight the first measurement to be printed press lt Mark gt e and select the last measurement to be printed All the measurements in between will be selected Press All rt to select all results Press Print to print your selection Records can be deleted from the database by marking them and pressing Delete P NOTE If you do not have permission to delete records the button will not be active 10 Press Ey to return to the lt Data gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 6 1 2 SRC Measurement Reports Not Ready 11 09 27 Dec Measurement Diagnostics Patient Eject USB Ma
99. Baro 738 0 Fig 7 21 Select New Gas Bottle Scan Gas Barcode for New Gas Bottle mm mmm Fig 7 22 Scan Bar Code Please Insert Gas Bottle em mm Fig 7 23 Insert Gas Bottle Fig 7 24 Gas Bottle Operator s Manual OPTI CCA TS2 7 MAINTENANCE The calibration gas bottle is designed to provide approximately 80 sampling operations 45 for B Lac The following message will alert the operator that the gas bottle needs to be changed Fig 7 21 To change the gas bottle l 2 Press lt New Gas Bottle gt Unscrew the gas bottle by turning the knob on the bottom counterclockwise Take a new gas bottle and remove its cap When prompted Fig 7 22 scan the new gas bottle bar code on the insert sheet by holding it 2 3 inches 5 8 cm from the bar code scanner on the bottom right hand corner of the analyzer e The red line from the barcode scanner should cover the entire barcode e The analyzer will beep when the barcode is accepted e Record the date of installation on the gas bottle for later reference NOTE If the insert sheet is misplaced you can enter the lot number on the gas bottle label manually Press lt Manual gt Fig 7 22 and enter the number using the numeric keypad NOTE The bar code contains expiration information The OPTI CCA TS2 will alert the operator four weeks before the gas bottle expires NOTE The gas bottle should always be stored wit
100. Blood Gas Systems OPTI CCA TS2 Analyzer Operator s Manual gt OPTIMedical OPERATOR S MANUAL REVISION LOG Please record any changes made to this manual Revision Release Date Approved by Description A March 2013 per PCR120182 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 2013 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 States 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 Rosw
101. C C GIL Fig 3 70 Select Language Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION This menu lets you choose the language you want the OPTI CCA TS2 to use for displays and printouts 1 Inthe main menu select System Manager and Setup 2 Inthe System Setup menu press the System tab and then Language Fig 3 69 3 Select the desired language Fig 3 70 4 Press to accept the changes 5 Press L to return to the lt Setup gt screen or to return to the main menu 3 CUSTOMIZATION 3 2 4 4 Hardware Settings The lt Hardware gt menu is used to adjust the local barometric pressure the audible alarm and standby mode 3 2 4 4 1 Entering the Barometric Pressure System gt Setup To adjust the tracking barometer within the OPTI CCA TS2 follow the instructions below 1 Inthe main menu select lt System Manager gt and lt Setup gt Printer Hardware Comm Ethernet wins Fig 3 71 Select Hardware 2 Inthe System Setup menu press the System tab and then Hardware to select this function Fig 3 71 oe Me mper m 3 Press wa to enter an offset from the true i 21 M Ready 16 20 ar barometric pressure Fig 3 72 Barometer Current Offset Offset 0 0 mmHq 0 0 Audio K 4 Type in the new numbers and press to Beep Enable Iv nne accept the changes Beep Volume e Battery 5 Press Es
102. Calculated Limits Limits panel Correlation u lS Fig 3 6 Select Control System gt Setup gt Control Scan Next Barcode Now ma em Fig 3 7 Scan Bar Code Operator s Manual OPTI CCA TS2 When you open a new box of OPTI CHECK or OPTI CHECK PLUS 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 TS2 and have assigned assay ranges for each measured parameter NOTE The procedure for programming QC ranges as described below is identical for all levels NOTE The OPTI CCA TS2 can save information for one lot of OPTI CHECK and one lot of OPTI CHECK PLUS concurrently for each level 1 Inthe main menu select System Manager and Setup 2 Enter security information if enabled see Section 3 2 3 1 3 On the lt Patient QC gt tab select Control Fig 3 6 4 Take the bar code sheet out of the OPTI CHECK box and scan Barcode A for the applicable level of OPTI CHECK or OPTI CHECK PLUS Fig 3 7 e Hold the bar code 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
103. 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 7 8 7 3 7 MAINTENANCE QC gt tHb Measuring Fig 7 9 Close Cover Measuring tHb Calibration in Progress Please Wait Measuring Rm zen Fig 7 10 tHb Calibration tHb Calibration in Progress Please Remove the Cassette Fig 7 11 Remove Calibrator 7 Close the sample chamber cover Fig 7 9 e After the cover has been closed the instrument will automatically detect the presence of the calibrator cassette and begin calibration Fig 7 10 8 After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette Fig 7 11 9 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 Operator s Manual OPTI CCA TS2 QZ OPTIMedical OPTI CCA TS2 HbCal Report DD MMM YY HH MM S N XXXX Version X XX XXXX User ID User 123 HbCal LOT XXXXXX Exp Date MMM YYYY 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 FA 0 000 0 000 F5 0 000 0 000 G1 1 062 G2 1 087 G3 1 082 Fig 7 12 HbCal Report Kl 17 53 04
104. Connected and you have a valid IP address not all zeros Packets 4458 5257 Fig 3 85 ES Fig 3 85 Ethernet Test 3 38 Operator s Manual OPTI CCA TS2 System gt Setup gt Ethernet Ready IP Type IP Address K 16 20 21 Mar Dynamic Static Lol 9 255 255 255 255 Lad Subnet Mask 255 255 255 255 k Discovery Port 6703 Lad Cancel Defauts F Save u ld Fig 3 86 Ethernet Settings Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 4 Go back to the lt System gt Setup gt Ethernet gt screen Fig 3 86 and make the following selections IP Address static IP address of instrument if applicable Subnet Mask mask for subnet Discovery Portz port used for instrument discovery 5 Press to accept the changes 6 Press EJ to return to the lt Setup gt screen or to return to the main menu The status bar displays when network connection is enabled Fig 3 86 with the network icon i 3 39 3 CUSTOMIZATION 3 2 5 Maintenance Setup Ready a 23 14 04 Jan Maintenance Fig 3 87 Select Maintenance System gt Maintenance Ready Ki 16 22 21 Mar Maintenance Pump Replacement Pump last installed Cleaning Last cleaning Fig 3 88 Maintenance Setup Maintenance gt Setup Ready Ki 16 22 21 Mar Replace Pump D Reminder Cleaning Reminder m 2 Weekly Monthly Cleaning c C
105. Data Qc System Manager anager Manager Gas 93 Battery 15 6V Baro 743 0 Temp 99 50 Not Ready lt Not Ready SRC Lockout gt If lt SRC Lockout gt has been activated in lt Setup gt Not Ready see Section 3 2 1 2 this message will be displayed SRC Lockout if SRCs have not been run within the specified time Er zem 1 e Press lt Run SRC gt and run SRCs see Section 4 5 1 Data ac System Manager Manager Manager Gas 93 Battery 15 6V Baro 743 0 8 14 Operator s Manual OPTI CCA TS2 Not Ready E Not Ready QC Lockout t Data QC Manager Manager System Manager Gas 32 Log Off d Baro 968 3 See Not Ready QC Lockout System Manager Manager Battery 15 6V Not Ready FSet Error Qc System Manager Manager Battery 15 6V Gas 93 Baro 743 0 Measurement Access Prohibited System s ET IS Luftdruck 729 2 Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING Not Ready QC Lockout gt If QC Lockout gt has been activated in Setup see Section 3 2 1 2 this message will be displayed if controls have not been run within the specified time e Press Run QC and run control materials see Section 4 5 3 Not Ready Remote Lockout gt The instrument has been locked remotely and cannot be used e Press D
106. E 7 MAINTENANCE 7 1 Daily Maintenance No daily maintenance is required for the OPTI CCA TS2 system 7 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 with a 10 1 diluted bleach solution A cotton swab may be used for cleaning the smaller parts of the SMC System gt Maintenance The OPTI CCA TS2 has a function that allows you rn BEN to select maintenance reminder options which will alert you when analyzer cleaning is due Maintenance Pump Replacement Dans Any maintenance actions that you perform through the maintenance reminders will be captured in the maintenance log of the analyzer Pump last installed Cleaning Done Last cleaning 1 From the lt Ready gt display select System Manager and Maintenance 2 Inthe Maintenance menu Fig 7 1 press Setup E Fig 7 1 Maintenance Setup 3 Inthe Setup screen Fig 7 2 you can Maintenance gt Setup select the option Cleaning Reminder Ready a 16 22 21 Mar Select lt Weekly gt for weekly maintenance and Gene Fe lt Monthly gt cleaning ifthe analyzer is not used ee ee on a weekly basis Cleaning Reminder m e EE m The analyzer will then remind you when the
107. ENEAN 6 15 Operator s Manual OPTI CCA TS2 6 i 6 DATA MANAGEMENT 6 DATA MANAGEMENT The lt Data Manager gt menu allows you to print out Measurement Diagnostics and Statistics Reports It also provides you with the ability to import and export information to a connected computer or by using a USB mass storage device 6 1 Printing Measurement and Statistics Reports 6 1 1 Patient Measurement Reports The lt Data Manager gt menu allows you to print out patient measurement reports Scan Cassette Barcode You can print out individual measurement results groups of measurement results or all the results in memory emm Manual Entry Data Qc Manager Manager Gas 99 Baro 737 7 Fig 6 1 Data Manager Not Ready 11 09 27 Dec Measurement Diagnostics mi SRC me 2 On the lt Measurement gt tab select Patient Eject USB Mass Fig 6 2 Storage Device In the default setting patient reports are set to print automatically after each measurement Last Entry Information on how to change these settings can be stem anager found in Section 3 2 4 1 So 1 To print a patient report select Data Managers in the main menu Fig 6 1 Patient Controls Miscellaneous Reports Configuration Maintenance ES Fig 6 2 Select Patient Report Operator s Manual OPTI CCA TS2 6 1
108. GJ Lej kel al la Lal el In Fig 8 36 Enter User ID System gt Diagnostics gt B Lac Setup Ready Ki 14 34 28 Dec To set up B Lac cassette up to 8 Level 2 OPTI Check Cantrole met he rin B Lac setup is complete Are you sure you wantto reset mr num zm m Fig 8 37 B Lac Setup Operator s Manual OPTI CCA TS2 The B Lac Setup menu is used to enable the running of lactate cassettes The B Lac 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 Contact Customer Service to order a B Lac Setup Kit BP7657 free of charge This is not a troubleshooting procedure Call Technical Support for further assistance In the main menu press System Manager gt Diagnostics e Select the Tests tab e Press Setup B Lac gt Fig 8 35 e Enter the security information if enabled Fig 8 36 Information on security functions can be found in Section 3 2 3 NOTE Bar coded user IDs may be entered from this screen using the bar code scanner This message Fig 8 37 is displayed if lactate is already set up e Press to keep the current settings and cancel the setup process e Press to start the setup process 8 31 8 DIAGNOSTICS AND TROUBLESHOOTING
109. Gas Pressure age 8 19 824 e lee We ansehen 8 20 925 VEN VINE Barometric TE 8 20 8 26 Checking the Battery Voltage fa ieiniccicicetececcceccsasaieciacteiaarenrncescmesnceqnursenancddaceceeaenmetuemtes 8 21 8 2 7 Checking the Cooling Fan nn 8 21 920 Checking the Gas ValVBs site oue ae 8 22 8 2 9 Checking the Valve Dive nee nase 8 22 8 2 10 Checking the Factory Settings F S60 anna a 8 23 8 2 11 Checking the Bar Code Scanner 8 23 8 2 12 Checkingihe pz em 8 24 8 2 19 Chiecking he OP E Tc 8 25 8 2 14 Checking the Ethernet EE 8 26 8 2 15 Checking the Pump Flow ENER EES esaii 8 27 8 2 16 Checking trie Pump Motor ea 8 28 8 2 17 Checking TE 8 28 8 2 18 Checking the Touch SPOS EE 8 29 8 2 19 Gas Test nn ee 8 30 98 2 20 Selling Up tie B Lac Cassette iuc ooi stor ten o pen essa tura oer encoders 8 31 A Cassette Dot near 8 33 8 3 fl VE d e D 8 34 8 3 1 Troublesnooting Procedure or IDIDESU ae 8 34 8 3 2 Troubleshooting Procedure for Bar Code Scanner eeeeseessss 8 35 Operator s Manual OPTI CCA TS2 8 i 8 DIAGNOSTICS AND TROUBLESHOOTING 8 DIAGNOSTICS AND TROUBLESHOOTING Your OPTI CCA TS2 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 action This chapter describes OPTI CCA TS2 specific system messages and recommends steps that should return your anal
110. I CCA TS2 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 TS2 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 TS2 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 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
111. In the main menu press lt System Manager gt Diagnostics gt e Select the lt Hardware gt tab e Press the Open button under Gas Valve to start the test Fig 8 9 e A faint hissing sound may be heard with the pump cartridge removed and the gas valve open e Press s to return to the System screen to return to the main menu This diagnostic checks the proper operation of the cassette valve drive mechanism In the main menu press System Manager gt Diagnostics e Select the Hardware tab e Press va Fig 8 10 and enter the various positions allowed positions are 1 12 to verify the valve drive moves smoothly and precisely e Press et to return to the lt System gt screen to return to the main menu Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 10 Checking the Factory Settings FSet System Diagnostics Sensors Cassette Valve Drive Position Ken L 16 19 Hardware Tests r Fan r Gas Valve On Off Open Closed e C e C 21 Mar Fig 8 11 Factory Settings The lt FSet gt function Fig 8 11 is designed exclusively for use by authorized OPTI Medical personnel and requires a special User ID and password e Press 4 to return to the System screen or to return to the main menu 8 2 11 Checking the Bar Code Scanner System gt Diagnostics Ready a 16 19 Sensors Hardware 21 Mar Tests
112. Jan Scan Cassette Barcode Ready Manual Entry Last Entry Data Qc Manager Manager Gas 99 Baro 737 7 i System Manager Fig 7 13 Ready Screen Operator s Manual OPTI CCA TS2 7 MAINTENANCE The unit will now begin printing the tHb Calibration Report showing both the old and new calibration results and calibration factors Fig 7 12 Once the Hb Calibration is complete the lt Ready gt display will appear Fig 7 13 7 MAINTENANCE 7 4 Annual Maintenance 7 4 1 Replacing Peri Pump Cartridge 7 6 Fig 7 14 Remove Pump Cartridge v A Fig 7 15 Pump Seals Fig 7 16 Install New Cartridge Once a year the peristaltic pump cartridge and gas I O port must be replaced to assure that your analyzer operates at peak performance To change the cartridge 1 2 Open the printer cover door by pressing the red printer release button 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 7 14 Replace the pump seals Fig 7 15 only if they are damaged or clogged Remove the old pump seals with a pair of hemostats or tweezers 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 Inst
113. M 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 TS2 ANALYTES PO Dry Sensor Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below Dry PO mmHg OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 73 5 103 5 139 1 Within Run St Dev S 1 4 0 9 1 4 Within Run CV 1 8 0 9 1 0 Total Precision St Dev S 1 6 1 3 2 0 Total CV 2 2 1 3 1 5 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 wa
114. Measured Parameters sss 3 11 3 2 2 3 Setting up Calculated Parameters 3 12 3 2 2 4 Setting up Limits for Measurement Parameters sss 3 13 3 2 2 5 Setting up Limits for Calculated Parameters sssse 3 15 3 2 2 6 Setting Up Test Panels nern anne nen 3 17 3 2 2 7 Setting up Correlation Fachors ee eee 3 19 3 2 3 Setting UP SOCUMIY MR ee 3 20 9 2 3 1 Selecting Security Settings ende 22H 3 20 3 2 3 1 1 Security Setlirigs imde tole glacie ova Hee EH SEE co et nee 3 21 3 2 3 1 7 Setting up UserlDS uns oir ee reicher Leod ed noe sche ets Ebrei EErEE 3 22 3 2 3 1 3 Setting Up User Grou E 3 24 3 2 3 2 Setting p a ET DEE 3 26 3 2 3 3 System Reinitialization sese eene 3 27 3 2 4 TEE Ile GE 3 28 9 2 4 1 Seting the Printer iere t o eet ete ee E dnd eed n td 3 28 3 2 4 2 Defining UNIS iiec ra ea en nenne Corde era Laos pe Ede owe gera rx RR 3 29 29 2 4 9 Selecting d Language Riesen 3 31 3 2 4 4 Hardware Settings uie x hx EORR S HU LIA I EEE 3 32 3 2 4 4 1 Entering the Barometric Pressure eere 3 32 3 2 4 4 2Beep Adjustment un nee een 3 33 3 2 44 3 Standby EE 3 34 3 2 4 5 Setting up Communtcatons ener 3 35 3 2 4 6 Configuring Ethernet Gettngs cece etter rere nner nemen 3 38 3 2 5 Maintenance Setup a 3 40 Operator s Manual OPTI CCA TS2 3 i 3 CUSTOMIZATION 3 CUSTOMIZATION Your OPTI CCA TS2 analyzer is shipped preset to easi
115. N System gt Setup gt Units g dL g L LO mmol L mg dL Ca c C mmol L mg dL Glucose C c mmol L mg dL Urea BUN e o mmol L mg dl Lactate Ze C Cancel ES Fig 3 68 Parameters Resolution examples are shown in the following table Low pH 7 34 PCO 43 mmHg PO 87 mmHg Na 143 mmol L K 4 6 mmol L CT 103 mmol L Ca 1 21 mmol L Glu 5 71 mmol L BUN 18 5 mg dL Lac 14 5 mmol L tHb 14 6 g dL SO 90 High pH 7 341 PCO 43 2 mmHg PO 86 8 mmHg Na 143 3 mmol L K 4 57 mmol L Cl 103 1 mmol L Ca 1 21 mmol L Glu 5 71 mmol L BUN 18 5 mg dL Lac 14 5 mmol L tHb 14 6 g dL SO 89 8 5 Press the Parameter tab to go to the next screen Fig 3 68 and select the units for the remaining parameters Your OPTI CCA TS2 has been factory preset to the following units Baro Partial Pressure Temperature Resolution tHb Electrolytes Glucose BUN Lac mmHg eC High g dL mmol L mg dL mg dL mmol L 6 Press sae ia accept the changes 7 Press d to return to the Setup screen or to return to the main menu Operator s Manual OPTI CCA TS2 3 2 4 3 Selecting a Language System gt Setup Fig 3 69 Select Language System gt Setup gt Language Ready Ki 16 20 Select Language English Espanol Frangais C utsch Italiano C AAR FAX C J zyk polski Portugu s C Russian Turkish C Romanian C Arabic Farsi 21 Mar c Cc c C C
116. O 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 TS2 ANALYTES Reproducibility Controls Within run precision S and Total Precision S were determined from 2 runs per day with 2 replicates PCO Dry Sensor per run over a period of 20 days following the CLSI guideline EP5 A2 Typical results for 3 different control levels are shown below Dry PCO mmHg OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 72 6 43 1 22 5 Within Run St Dev S 0 8 0 3 0 3 Within Run CV 1 1 0 7 1 4 Total Precision St Dev S 1 2 0 6 0 4 Total CV 1 696 1 396 2 096 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 9o CV 2 3 44 10 6 n 18 18 18 Linearity The linearity of the dry PCO sensor was established using who
117. PTI CCA TS2 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 90 2 7 22 5 4 5 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 used 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 TS2
118. PTI CCA TS2 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 photons 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 ofthe 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
119. S 1 5 1 7 1 8 Total CV 2 196 1 7 1 3 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 systems All values are in mmHg Expected n Observed Swr bias Recovery 20 8 7 21 2 0 97 0 4 102 41 5 7 39 9 1 03 1 6 96 48 6 7 50 0 0 84 1 4 103 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 96 499 5 7 485 9 16 22 13 6 97 96 PO2 2 Operator s Manual OPTI CCA TS2 ANALYTES PO Linearity Wherever possible linearity for the OPTI CCA TS2 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 TS2
120. TE For application of QC Lockout please refer to section 3 2 1 2 Fig 4 11 Remove the cassette NOTE Verify with your particular regulatory agency and your internal policy regarding number of levels and frequency of SRCs to be run Operator s Manual OPTI CCA TS2 4 7 4 CALIBRATION AND QUALITY CONTROL 4 5 2 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 only use the manufacturer recommended controls 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 PO 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 arange of measurement values typically seen in a laboratory The results obtained should fall within limits established by the user s laboratory 4 5 2 1 Running Controls OPTI CHECK OPTI CHECK PLUS Kl 17 53 04 Jan Scan Cassette Barcode 1
121. TS2 exports data string identical to the internal printer output e Press to accept the changes 3 35 3 CUSTOMIZATION system gt Setup gt Communications e lt ASCII Ethernet Fig 3 78 Data in easy LEE L usd ae RI to read OPTI Medical custom format The OPTI Protocol ASCII Ethernet wi CCA TS2 exports data string identical to the IP Address ooo internal printer output Port ron kal e Enter IP address of the host computer and port e Press to accept the changes Cancel Defauts F save Lt Fig 3 78 ASCII Ethernet e ASTM Serial Fig 3 79 Complies with ASTM standard Please refer to OPTI CCA TS2 interface specifications for more information System gt Setup gt Communications e Select lt ASTM Handshaking gt Ready Ki 16 19 21 Mar TE lt None gt all data is sent without an acknowledgement Single communication is established ASTM Handshaking and all data 1s sent in a single message with None Single Full acknowledgment e e Full communication is established and each record is sent separately with an acknowledgement E Press to accept the changes Fig 3 79 ASTM Serial e ASTM Ethernet Fig 3 80 Complies with ASTM standard Please refer to OPTI CCA TS2 interface specifications for more information System gt Setup gt Communications CUN E Lie EGET e Enter IP address of the host computer and port Protocol ASTM Ethe
122. _ to accept the changes 7 Press d to return to the Setup screen or to return to the main menu 3 10 Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 2 2 2 Suppressing Results for Measured Parameters In the lt Measured Parameters gt menu you can Ready 11 17 10 Dec suppress results for certain parameters The results Patientac Security System for these parameters will not appear in the stored iis patient results or on the printout Control Lockout e Inthe main menu select System Manager Customizing Patient Information Patient Measured Calculated and lt Setup gt Entry Parameters e On the lt Patient QC gt tab press Measured nn Parameters gt Fig 3 19 The lt Parameters gt tab contains the following options Fig 3 20 Fig 3 19 Measured Parameters e Allow Blanking gt If this option is selected a screen will appear before a patient measurement giving the user the option to suppress the results for certain parameters for System gt Setup gt Measured Parameters Not Ready Ki 11 32 10 Dec Parameters Settings the current measurement Allow Blanking D e Reported Parameters To permanently eee CERES suppress results for all patient and control pH Iv Ca Iv PCO2 F Glu y measurements for all cassette styles deselect the P02 UrealBUN WM specific parameters in the parameter list n
123. age 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 4 1 oem Leen NOTE Instead of scanning the barcode in the main menu SRC measurements can also Fig 4 1 Scan Barcode be run from the OC menu by pressing lt QC Manager gt QC gt SRC gt Enter User ID LU e e The red line from the bar code scanner should cover the entire bar code A beep indicates a valid bar code e F E E F t s E 5 E 1 A red status light indicates an invalid bar code e g SRC expired NOTE If the bar code is damaged or unreadable press lt Manual Entry gt and enter the bar code digits using the keypad E E E EI F E E F F F E E d F lt a 2 If lt Non Secure User ID Entry gt is enabled in E cores amp the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 4 2 Fig 4 2 Enter User ID NOTE Bar coded user IDs may be entered from this Measuring 13 14 10 Dec screen using the bar code scanner Oaiant COA L nunttel tn Dun 3 A warning will be displayed when a new SRC lot is used Fig 4 3 Press lt Continue gt WARNING New SRC Lot Cancel Continue Cancel OK Fig 4 3 New SRC Lot 4 4 Operator s Manual OPTI CCA TS2 4 CALIBRATION AND QUALITY CONTROL 4 Select
124. all 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 7 16 Operator s Manual OPTI CCA TS2 Fig 7 17 Push on Pump Roller System gt Maintenance Ready Ki 16 22 21 Mar Maintenance Pump Replacement Done Pump last installed Cleaning 1 1 H H H H H H i Last cleaning e u LA Fig 7 18 Maintenance Setup Maintenance gt Setup Ready Ki 16 22 21 Mar Replace Pump E Reminder Cleaning Reminder E e Weekly Monthly Cleaning e Le Cancel Defaults B Save Fig 7 19 Replace Pump Operator s Manual OPTI CCA TS2 7 MAINTENANCE 5 Press the pump cartridge roller down until it firmly sits on the shaft of the pump motor Fig 7 17 6 Perform a Pump Test see section 8 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 The OPTI CCA TS2 has a function that allows you to select maintenance reminder options which will alert you when the next pump replacement is due Any maintenance actions that you perform through the maintenance reminders will be captured in the maintenance log of the analyzer
125. alues 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 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 introductio
126. an Bar Code bar code scanner located on the bottom right hand corner of the analyzer Fig 2 14 NOTE A tHb calibration can also be run Enter Mario from the OC menu by pressing lt QC Manager gt QC gt tHb Calibrator gt instead of scanning the barcode in the lt Ready gt screen e Ir E E E t Le n E E The red line from the bar code scanner should cover the entire bar code g F E F A beep and a green status light indicates a valid bar code I a E E g a E e f Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 2 15 Depending on security settings user access to running Hb calibrators may be restricted NOTE Bar coded user IDs may be entered from this screen using the bar code scanner 123 Cancel OK Fig 2 15 Enter User ID Kl 17 53 04 Jan Scan Cassette Barcode Ready WARNING New tHb Calibrator Cancel Continue Manual Entry Last Entry e A warning will be displayed the first time a new tHb Calibrator lot is used Fig 2 16 Press lt Continue gt Data Qc System Manager Manager Manager Gas 99 Baro 737 7 Fig 2 16 New Calibrator 2 6 Operator s Manual OPTI CCA TS2 2 SETUP e Gently clean the optics window and the Clean Optics and inside top cover of the sample chamber
127. 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 data management is contained in Chapters 5 and 6 Detailed maintenance and service information can be found in Chapters 7 and 8 Operating principles are described in Chapter 9 TABLE OF CONTENTS Table of Contents Symbol Definitions RTT VII x L Mem EUER IX ENEE Vor Senos E IX How 15 Use this manual M IX Tt INTRODUCTION nee 1 1 ir WE E RE 1 1 1 2 Principles of Operation ccccceeeeeeeeeeeeeeeeeeeeeeneeeeseeeeeeeeeeeeeeeeeeeeenesneeeeeees 1 1 13 CONntenis f 0X 1 2 14 Analyzer Components nee e caso a caue ea een ka bacon a Ede Eee e ken nnnc 1 3 1 3 e EE E 1 8 2 SETUP e i 2 1 2 1 Important Safety Instructions eiie ieu tou rar eege ege eeben 2 1 22 E ne ENEE ei 2 1 2 3 Setting up the OPTI CCA TS2 Analyzer eese 2 2 3 CUSTOMIZATION as an een en kenne 3 1 41 Setting Time and Date esse eas ee es a es 3 1 S EN 3 2 SUMMER DTE 3 3 3
128. ancel Defaults B Save Fig 3 16 Patient Information System gt Setup gt Patient Information Ready ai 11 20 10 Dec Available Functions Medical Record Number Account Number Test ID Patient Name i W Selected Functions Requir r Accession Number D r FT Fig 3 17 Patient Information Customizing Patient Information In this function you can define which patient information is required during as well as printed after each measurement e Inthe main menu select System Manager and Setup e On the lt Patient QC gt tab press Patient Entry gt Fig 3 15 In the lt Patient Information gt screen you can customize the list of patient information Fig 3 16 The top half of the screen displays all available options the bottom half shows the selected options 1 To add patient entry options to your list select the desired option in the lt Available Functions gt field in the top half of the screen Fig 3 16 Press the blue lt Down gt A arrow to move this option to your list in the lt Selected Functions gt field on the bottom 2 To remove options from your list press the lt Up gt t arrow 3 Press lt Required gt Fig 3 17 to make a patient entry option a required entry The default options for patient information are Patient ID 25 alphanumeric characters Accession No 25 alphanumeric characters Date of Birth DOB Month DD YYYY Sex unknown male or
129. anel System gt Setup gt Panel Not Ready Enable E wins Fig 3 37 Enable Panel Panel Name pH PCO2 PO2 Glu Lac tHb S02 Na Cl mm m m m Ca Urea BUN a a m m m Cancel Fig 3 38 Select Parameters Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION This menu allows you to set up and maintain customized analyzer test panels Customized test panels eliminate the need for device operators to repeatedly select test parameters for given situations For example your institution may require one sequence of tests for use in the emergency room and a different sequence of tests for the operating room You can set up and name test panel configurations using tests available on a cassette for these specific situations 1 Inthe main menu select lt System Manager gt and lt Setup gt 2 On the lt Patient QC gt tab press Panel Fig 3 36 3 Inthe lt Panel gt menu Fig 3 37 press lt Enable gt By default this option is disabled e When this option is enabled a pop up screen will appear when a cassette is scanned showing available panels The cassette default is always available e Only panels with parameters that are available on the cassette will be displayed E g if you set up a panel with Na K and Ca this option will only be displayed if you scan a cassette that measures these parameters e The instrument will gray out
130. anual OPTI CCA TS2 4 CALIBRATION AND QUALITY CONTROL QC gt SRE Results 9 Press the lt Level 2 gt and lt Level 3 gt tabs to u MSC display the results for the respective levels Level 1 Level 2 Level 3 NOTE Results obtained are applicable 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 ren be displayed and printed Ey e For parameters out of range or if an internal drift is detected lt Fail gt will be displayed Fig 4 10 SRC Results 2 NOTE The printout will start automatically when the first results are displayed This feature may be turned off in setup See Section 3 2 4 1 Additional information on printing reports can be found in Chapter 6 Data Management 10 Press Eu Fig 4 10 to exit the results screen 11 You will then be prompted to open the sample chamber cover and remove the SRC Fig 4 11 Please Remove the Cassette 12 Place the SRC back into its pouch immediately after removal from the instrument 13 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 in Chapter 8 of this manual NO
131. art 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 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 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 O
132. ary 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 TS2 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 TS2 system is designed to measure whole blood serum or plasma to be controlled with Standard Reference Cassettes on a daily basis and with aqueous solutions for each new lot of cassettes Aqueous controls are portable and quite convenient to use with the OPTI CCA TS2 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 o
133. as 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 TS2 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 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 TS2 ANALYTES BUN UREA BUN Urea Clinical Significan
134. at mM L g By default all parameters are activated K Vv tHb Iv e Press IB ze to save your selection Cancel Defauts save The Settings screen contains the following Nw Lt options Fig 3 21 Fig 3 20 Parameters e Last Barcode Enable enables the Last Entry button on the main screen so that the previous barcode scanned can be used for the current patient measurement By default this option is disabled e Last Patient Info Enable enables the Last Patient Info button shown during the measurement so that the patient information from the previous measurement can be used as the default for the current measurement By default this option is disabled Parameters Last Barcode Enable Last Patient Info Enable E Minimum Patient ID Digits 0 k l e lt Minimum Patient ID Digits gt lets you set Cancel Defauts a minimum number of required digits for the LE Patient ID Fig 3 21 Settings e Press to save the settings Operator s Manual OPTI CCA TS2 3 11 3 CUSTOMIZATION 3 2 2 3 Setting up Calculated Parameters 3 12 System gt Setup Ready Ki 11 17 10 Dec Customizing Patient Information Patient Measured E Parameters Measurement Calculated Limits Limits Calculated Parameters Fig 3 22 Calculated Parameters System gt Setup gt Calculated Parameters Not Ready Ki 11 33 10 Dec
135. ata Manager gt QC Manager or System Managers to exit this screen Not Ready FSet Error The factory settings have been corrupted and are not valid e Shut down the system and restart to attempt to clear the error e If the error cannot be cleared by cycling the power contact Technical Support for assistance Measurement Access Prohibited The user does not have privileges to run a patient measurement as defined by the security settings Section 3 2 3 e Press Data Manager QC Manager or System Managers to exit this screen 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 5 Fatal Error Messages Fatal Error Barometer Out Of Range ac System Manager Manager Fatal Error Cassette Valve ac System Manager Manager Fatal Error Dark Currents Data ac System Manager Manager Manager Gas 93 Baro 743 0 8 16 lt Fatal Error Barometer Out Of Range gt Barometer failure The barometer reading is outside measurement range e Shut down the system and restart to attempt to clear the error e Ifthe error cannot be cleared by cycling the power contact Technical Support for assistance lt Fatal Error Cassette Valve gt The cassette valve failed to find the home position e Shut down the system and restart to attempt to clear the error e Ifthe error cannot be cleared by cycling the power contact Technical Suppor
136. au Pressure Pplat Minute Volume MVOL VE Peak Inspiratory Pressure PIP Flow Rate Liter Flow FR Tidal Volume TVol VT Pressure Support Value PS Positive End Expiratory Pressure PEEP Rate f Continuous Positive Airway Pressure CPAP Total Hemoglobin tHb FIO 2 Operator s Manual OPTI CCA TS2 APPENDIX A TECHNICAL SPECIFICATIONS adult or fetal Off Pump On Pump RmAir Mask T P NC Vent Bag Hood Other Where RmaAir Room Air Mask Mask T P T Piece NC Nasal Cannula Vent Ventilator Bag Bag manual resuscitation Hood Hood Other Other No SIMV PS V 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 0 100 0 0 120 0 140 0 00 300 00 0 4000 0 0 99 9 0 50 0 155 0 50 1 0 26 0 g dL 0 62 16 14 mmol L 1 260 g L 0 21 1 00 A 3 APPENDIX A TECHNICAL SPECIFICATIONS Mean corpuscular hemoglobin concentration MCHC Respiratory quotient RQ P50 BiLevel Pressure Numerator BiLevel Pressure Denominator I E Ratio Numerator I E Ratio Denominator Comments Field Calculated Values
137. automatic detection of low gas or low battery dirty optics or worn pump conditions Operator s Manual OPTI CCA TS2 9 9 9 OPERATING PRINCIPLES 9 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 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 The multi level Standard Reference Cassettes SRCs should be used as a control for measurement and proper analyzer operation These cassettes can test at 3 levels and OPTI Medical Systems recommends that SRC measurements should be performed for levels 1 and 3 high and low values once each day of OPTI CCA TS2 operation The 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 devi
138. b 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 TS2 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 Multi Level Standard Reference Cassettes SRCs BP7652 Use For diagnostic and daily QC check of the OPTI CCA TS2 Contents Each package contains one reusable SRC Cassette Composition Stabilized optode sensors with assay values Level 1 Level 2 Level 3 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 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 Storage Refer to package labeling Sta
139. be f rmly into the f Ilport Fig 4 21 17 Press Fig 4 20 4 11 4 CALIBRATION AND QUALITY CONTROL Cassette Measurement In Progress Please Wait Measuring Oo 9 Fig 4 22 QC Measurement Measuring Ki 13 22 10 Dec ll um LS meter Fail on rare 7a60 780 mass Poz esi Lee Poz 1025 oronro mass Pe 144 122 153 mass sos sos 2 830 EN Fig 4 23 QC Results 0C gt Control Measuring 13 22 10 Dec Control Results PASS Accept Y Reject Review Fig 4 24 Accept QC Results 4 12 The QC sample is aspirated into the cassette and then measurement starts Fig 4 22 At this time the status light begins f ashing green indicating that the cover should not be opened Upon completion of the measurement the results are displayed Fig 4 23 The OPTI CCA TS2 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 Results obtained are applicable to the sensor cassette type being used for patient sample E Ca Type shown for reference 18 Press t Fig 4 23 to accept or reject results NOTE NOTE NOTE In the subsequent screen Fig 4 24 you can press Accept if results are acceptable and the results will be stored in the Control Database Select lt Reject gt to reject the results Rejected results will not b
140. bility Expiration date and lot number are printed on each package label and encoded on the attached bar code label 9 14 Operator s Manual OPTI CCA TS2 Calibration Gas BP7162 Use Contents Composition Storage 9 OPERATING PRINCIPLES For calibration of pH PCO and PO in the OPTI CCA TS2 Analyzer Each disposable low pressure cylinder contains 0 35 liters of gas at 28 psi at 21 C Oxygen 14 0 0 02 Carbon Dioxide 6 0 0 02 Nitrogen balance Refer to package labeling Hb Calibrator Cassette BP7653 Use Contents Composition Storage Stability Precautions For quarterly calibration of the OPTI CCA TS2 Analyzer Each package contains one reusable calibrator cassette Stabilized optode sensors Refer to package labeling Expiration date and lot number are printed on each package label and encoded on the attached bar code label 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 diagnostic 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 22
141. can Barcode NOTE If the insert sheet is misplaced you can enter the lot number on the gas bottle label manually Press Manual in the Scan Bar Code Screen and enter the number using the numeric keypad Operator s Manual OPTI CCA TS2 2 3 2 SETUP e When prompted Fig 2 7 insert the gas bottle in its housing and turn clockwise until PI Insert Gas Bottl ease Insert Gas Bottle fingertight Fig 2 8 Press o OK Cancel Fig 2 7 Insert Gas Bottle NOTE The gas bottle expires 6 months after installation or after exceeding the labeled expiration date whichever u comes first Pp NOTE The bar code contains expiration d information Four weeks prior to fh expiration of the gas bottle the OPTI CCA TS2 will alert the operator once as a reminder to order a replacement gas bottle Fig 2 8 Insert Gas Bottle e When this display appears Fig 2 9 press New Gas Bottle 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 to the New Gas Bottle prompt The next screen will prompt you to enter the number of weeks in service using the numeric keypad See section 7 5 3 Here you may refer back to the installation date which was recorded on the gas bottle Fig 2 9 New Gas Bottle The OPTI CCA TS2 will now begin to warm up and perform a gas purge which will be indicated by a progress bar dis
142. ce 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 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 inb
143. ce is consistent The results obtained should fall within limits supplied with the SRCs For SRC limit values see analyte section of this manual All specific performance specifications reported in this summary are determined from the above minimal recommendations for quality control verification The Standard Reference Cassettes are a complemetary method 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 On the OPTI CCA TS2 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 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 complementary 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 TS2 s electronic optical simulator checks the electronics optics thermostats 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 def
144. cent 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 TS2 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 x 2 mmol L Operator s Manual OPTI CCA TS2 CI 1 CHLORIDE ANALYTES Interferences The OPTI CCA TS2 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 TS2 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 fluori
145. chnical assistance 9 3 Technical specifications A 1 Temperature corrected values A 4 Temperatures system checking 7 15 Test conditions 5 4 8 6 Test panels setting up 3 16 tHb Calibration Cassette 1 9 Thermal printer See Printer Tilt stand 1 7 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 test 7 25 Troubleshooting 7 1 bar code scanner 7 38 procedure for tHb SO2 7 37 U Units of measure conversion A 8 setting up 3 27 used for calculations A 7 USB Type A port 1 6 USB Type B port 1 6 User groups 3 22 Users setting up 3 21 V Valve drive checking 7 18 Versions checking 7 14 W Warranty registration 9 4 Whole blood samples 5 4 Operator s Manual OPTI CCA TS2
146. cidosis 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 characteristic pKa lo ig pre Reig Lan 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 TS2 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 te
147. creen or A to return to the main menu Operator s Manual OPTI CCA TS2 3 2 4 5 Setting up Communications System gt Setup Ready Ki 16 24 21 Mar Patient QC Security System Hardware Comm Ethernet Lt LAJ Fig 3 75 Communications System gt Setup gt Communications Ready Ki 16 19 21 Mar Protocol ASCII Ethernet ASTM Serial ASTM Ethernet POCT1A Ethernet Removable Media L LG Fig 3 76 Select Protocol System Setup Communic ations Ready Ki 16 19 21 Mar Protocol ASCII Serial T Fig 3 77 ASCII Serial Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION The OPTI CCA TS2 has a USB Type B port and an Ethernet port that may be used to communicate with a remote computer These ports may be selected to transmit data in ASCII ASTM or POCTI format There is a USB Type A port that may be selected for exporting data to a removable mass storage device 1 Inthe main menu select System Manager and Setup 2 Inthe System Setup menu press the System tab and then Comme Fig 3 75 e Inthe lt System gt Setup gt Communications gt screen Fig 3 76 you can select the communications lt Protocol gt e lt ASCII Serial e ASCII Ethernet e ASTM Serial e ASTM Ethernet e lt POCT1AEthernet gt e Removable Media e ASCII Serial Fig 3 77 Data in easy to read OPTI Medical custom format The OPTI CCA
148. d develop their own policies on the frequency and type of QC based on the regulatory requirements The instrument is factory set with lockout options turned on To change these settings follow the steps below e Inthe main menu select lt System Manager gt and lt Setup gt Select lt Lockout gt in the lt Patient QC gt tab Fig 3 11 e The lt Lockout gt menu contains 3 screens lt SRC gt lt QC gt and lt New Lot gt Option 1 lt SRC Lockout Enable Fig 3 12 When this option is enabled SRC measurements must be performed at specified intervals for patient measurements to be allowed 1 To specify the number of SRC measurements to be performed make sure Lockout By Level Enable is not selected and select 1 2 or 3 in the By Number option 2 To specify the levels to run select Lockout By Level Enable and the levels to run in the By Level option 3 Define the time interval during which SRC measurements must be run Options are 8 12 24 hours and 7 days 4 The defaults are set to run Level 1 and 3 every 24 hours OPTI QC recommendations 5 To disable SRC lockouts deselect lt SRC Lockout Enable gt 6 Press to accept the changes NOTE The selected time interval starts with the time this feature is activated 3 5 3 CUSTOMIZATION System gt Setup gt Lockout Ready SRC 5 ac 12 21 10 Dec Option 2 lt QC Lockout Enable gt Fig 3 13 New Lot
149. de cause significant interferences to the electrolyte sensors Reproducibility Controls Within run precision S and Total Precision S were determined from 2 runs per day with 2 replicates per run over a period of 10 days following the CLSI guideline EP5 A2 Typical results for 3 different control levels are shown below CT mmol L OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 10 10 10 Total Average 95 3 107 1 115 6 Within Run St Dev S 0 6 1 4 0 5 Within Run CV 0 7 1 3 0 4 Total Precision St Dev S 0 7 1 4 0 6 Total CV 0 8 1 3 0 5 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations Specimens at each level were analyzed in replicates of two for 10 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 TS2 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
150. 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 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 tiss
151. des 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 TS2 using the measured pH Measurement Range Range Resolution Low High Units 100 to 180 1 0 1 mmol L Standard Reference Cassette SRC Limit Values LOW NORMAL HIGH Units 125 0 2 145 0 2 165 0 x2 mmol L Operator s Manual OPTI CCA TS2 Na 1 SODIUM ANALYTES Interferences The OPTI CCA TS2 Na sensor has no measurable interference from K variation within the range 0 8 10 mmol L The OPTI CCA T2S Na sensor does exhibit a small interference from Lit Lit 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 mea
152. e mg dL OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 10 10 10 Total Average 40 5 95 7 316 2 Within Run St Dev S 1 6 3 5 7 5 Within Run CV 3 9 3 6 2 4 Total Precision St Dev S 2 4 4 4 9 4 Total CV 5 9 4 6 3 0 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations Specimens at each level were analyzed in replicates of two for 10 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 TS2 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 Operator s Manual OPTI CCA TS2 Glu 3 GLUCOSE Correlation to Other Methods ANALYTES OPTI CCA TS2 vs other pH Blood G
153. e 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 9 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 Properly identify the specimen following usual procedures for such documentation Place the syringe containing the specimen in an ice slurry Blood gases and pH conte
154. e Press Pump to start the test Fig 8 27 e The pump will automatically step through all the speeds used during normal operation 7 5 to 120 rpm revolutions per minute Fig 8 28 and return to the lt Tests gt screen The purpose of this test is to check the proper operation of the display In the main menu press lt System Manager gt Diagnostics gt e Select the lt Tests gt tab e Press lt Display gt to start the test Fig 8 29 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 Ka to return to the lt System gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 18 Checking the Touch Screen System gt Diagnostics Ready 16 19 21 Mar Sensors Hardware Tests Barcode Printer Optics LE Ethernet Flow Pump L_ 1 Display Touch Gas Test E wire Fig 8 30 Select Touch Test System gt Diagnostics gt Touch Test Not Ready E 00 39 14 Dec Please Verify Touch Calibration KSE Fig 8 31 Perform Touch Test d Fig 8 32 Touch Calibration Operator s Manual OPTI CCA TS2 The purpose of this test is to check the proper operation of the touch screen In the main menu press lt System Manager gt Diagnostics gt e Select the lt Tests gt tab e Press lt Touch gt to sta
155. e 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 9 12 Operator s Manual OPTI CCA TS2 9 OPERATING PRINCIPLES 9 5 10 Interferences Selected substances endogenous and exogenous to human blood were tested for interference in accord with CLSI EP7 A2 gt 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 TS2 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 tested 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 Ki is released from the blood cells thereby increasing the measured K In the same manner pro
156. e bar code label or it is an invalid bar code for the OPTI CCA TS2 e Press to retry e If the error message appears again check the product package for intended use e Check the bar code scanner see Sections 8 2 11 or 8 3 2 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 lt ERROR Invalid Barcode Check Time and Date gt The bar code was invalid The OPTI CCA TS2 either misread the bar code or the product i e gas bottle cassette or SRC has expired e Press to retry e If the error message appears again check the date in lt System gt Time and Date gt e Verify the product expiration date lt ERROR Invalid Barcode Different QC Lot gt The bar code was invalid e Verify that Barcode A gt and Barcode B of the QC material is from the same level and lot number e Press to continue ERROR Expired Barcode The cassette expiration date has been reached e Press to retry e If the error message appears again check the date in lt System gt Time and Date gt e Verify the product expiration date 8 9 8 DIAGNOSTICS AND TROUBLESHOOTING ERROR Invalid tHb Calibrator ERROR Invalid QC Lot ERROR Need Setup QC ERROR User ID Already Exists ERROR Invalid User ID ERROR User Expired 8 10 ERROR Invalid tHb Ca
157. e difference in concentrations of major cations and anions in the blood specimen AG Na K Cl HCO3 mmol L The ionized calcium value normalized to pH 7 40 For blood nCa pH 7 4 Ca 10 929974 mmol L For plasma or serum na pH 7 4 Ca 10 0 24 pH 7 4 mmol L Simmons A ed Hematology A Combined Theoretical amp Technical Approach pp 28 29 Philadelphia W B Saunders 1989 Operator s Manual OPTI CCA TS2 A 13 APPENDIX B MENU STRUCTURE APPENDIX B MENU STRUCTURE Dao sep dnjas ape ES TUI seg Uonjejo 102 uyono p le 158 yonol joued Aeyds q J spu 9e dung u g away gt SIT Spa WOH gg Zr snoauejjeosiw wwog UeJed 9je2 aseqeyeq E 99j Sq31 ejempieH UleJeg Spa S043 gt Ge SAUA ONLA jane seg abenbue ezyjeniuiey Anua jueneq Sjouo Sonuo9 Eus 9NPA seo emjejeduio sun sBumeg n0y90 eoueusjureyy JS ECK ueg SUOISIOA eu Md 9Bueu Jou0 uomeunByuo juened qUaHEd T Y A x d D D 5 ry i e 7 N d d d Suodey Suodey syoday Sieal SJEMPIEH 10SUaS DEG Ayunaas Kell nosuejeosiA Soen fo juawaunseayy me A A A e A gt A A A i eoueuojule N dree sjoUOI A D C gt C N UZ juegeq SIS sonsouBeiq aeq pue eui qH ous f f C C jueueinsee Jo eueyy weIsig Jebe
158. e stored in the Control Database Select Reviews 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 Data will be exported using the configured export method see Section 3 2 4 5 when the results are printed The automatic printout feature may be turned off in setup See Section 3 2 4 1 Additional information on printing reports and exporting data can be found in Chapter 6 Data Manager For troubleshooting refer to Chapter 8 19 When prompted open the sample chamber cover and remove the cassette If other levels of controls are to be run repeat the procedure Operator s Manual OPTI CCA TS2 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling ccceeeeseeeeeeeeee 5 1 5 1 1 Sale 5 1 5 1 2 Sample Requirements nennen enne nen nennen nnne nennen 5 1 5 1 3 Anticoagulants and Sample Collection Devices oucii anii rna ta Reina clt hcic 5 1 SM ME d NENNT US PET TERCER HEN 5 2 5 1 5 Capillary TUDES T 5 2 5 1 6 OPTI Medical ComfortSamplers uunsssssssssssssssnnnnnnnnnnnennnnnnnnnnnnnnennnnnnennn nn 5 2 5 1 7 Handling and Sto
159. e 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 TS2 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 selected s0 H Io Q 1 Adult lgQ 2 9 IgPO 1 661 10 Im 4 172 lgPO 1gPO 0 48 pH 7 4 E 0 0013 BE P 26 7 Fetal lgQ 2 9 Ig PO 1 363210 905970 4 113 D lgPO lgPO 0 48 pH 7 4 WC 0 0013 BE Po 21 5 l 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 2 tHb 0 00314 PO 100 vol 7 NOTE If PO is not available ctO
160. ease 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 10 4 Operator s Manual OPTI CCA TS2 ANALYTES elo EE pH Dry Sensor B Lac Cassefle u a EE ee Nee kt PCO Dry Sensor B Lac Cassette sis PO senken PO Dry Sensor B Eac Cassette usa Sodium Q5 uj E Potassium I e lonized Calcium Gal sioe et ee Sc sie CT U M OS GIU PM TTC ODD BUN Urea m Lactate B Lac CASS ee sei costo otc lixex niue s nra d pis MUE E dn and UEE Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO 6 sss Operator s Manual OPTI CCA TS2 ANALYTES 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 hy
161. easure 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 TS2 incorporates a pressure transducer which accurately tracks the local barometric pressure and automatically compensates for it The OPTI CCA TS2 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 LOW NORMAL HIGH Units 60 0 3 100 0 3 170 0 3 mmHg Operator s Manual OPTI CCA TS2 PO2 1 PO ANALYTES Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below PO mmHg OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 71 6 100 0 137 7 Within Run St Dev S 1 3 1 4 1 4 Within Run CV 1 8 1 4 1 0 Total Precision St Dev
162. ed 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 7 600 0 02 pH units Operator s Manual OPTI CCA TS2 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 TS2 utilizes an internal Na sensor to actively compensate and correct for this sensitivity That is the OPTI CCA TS2 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 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 TS2 system Colored materials including proficiency testing
163. eeeeees 2 1 2 2 Choosing a LOCATION an anne ea 2 1 2 3 Setting up the OPTI CCA TS2 Analyzer eene 2 2 Operator s Manual OPTI CCA TS2 2 i 2 SETUP 2 SETUP 2 1 Important Safety Instructions Before you begin installing your OPTI CCA TS2 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 TS2 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 30 C 50 86 F Maximum relative humidity of 95 non condensing Ample room to allow air to circulate around the unit Away from strong 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
164. ees D 1 SRC Measurement Report ENEE D 2 SRC Statistics Report sssssssssssssssssssssssseeee eene eene nene nennen ne en nennen nennt nennen D 3 Controls Measurement Report ssssssssssssssssssssssseeeee enne nen nne nnnen nnne nennen nnn D 4 Controls Statis cs REDON EE D 5 Maintenance Report suce coca tea en D 6 Error Report D 7 B Lac Setup Report een u en nennen D 8 Operator s Manual OPTI CCA TS2 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 TS2 A 1 APPENDIX A TECHNICAL SPECIFICATIONS Operating Parameters Minimum Sample Size Sample Type Sample Application Sample Input Analys
165. eference 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 2 2 4 of this manual 9 5 8 Specific Performance Characteristics All performance data in this section was generated on OPTI CCA TS2 systems with the SRC run daily to check QC Quality control material was run with each new lot of cassettes 2 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 Operator s Manual OPTI CCA TS2 9 11 9 OPERATING PRINCIPLES 9 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 necess
166. elect the Tests tab e Press lt Printer gt to start the test Fig 8 15 e The printer will output a test print e 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 e Turn the OPTI CCA TS2 off e Remove the paper roll and pump cartridge e Unscrew the two thumbscrews holding the printer in place e Pull printer up and out towards the paper tray e Disconnect the cable from the receptacle e Install the new printer in reverse order e Press Ka to return to the lt System gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 13 Checking the Optics This option checks the output of the six optics channels This test is designed for trained service personnel Ready Sensors In the main menu press lt System Manager gt Diagnostics gt e Select the lt Tests gt tab e Press lt Optics gt to start the test Fig 8 16 Fig 8 16 Optics Test Not Ready Ki 00 36 14 Dec Cassette Type e Select the Cassette type and press SRC Fig 8 17 Patient Cassette False Light Cassette e No Cassette mum Fig 8 17 Cassette Type Optics Test e Insert the cassette and close the cover Insert Cassette and Close Lid Fig 8 18 Fi
167. ell GA 30076 USA www optimedical com PD7301 REV A 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 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
168. emove a cell or battery from its original packaging until required for use Do not subject cells or batteries to mechanical shock In the event of cell leaking do not allow the liquid to come in contact with skin or eyes If contact has been made wash the affected area with copious amounts of water and seek medical advice Do not use any charger other than that specifically provided for use with the equipment Observe the plus and minus marks on the cell battery and equipment and ensure correct use Do not use any cell or battery which is not designed for use with the equipment Do not mix cells of different manufacture capacity size or type within a device Keep cells and batteries out of reach of children Seek medical advice immediately if a cell or a battery has been swallowed Always purchase the correct cell or battery for the equipment Keep cells and batteries clean and dry Wipe the cell or battery terminals with a clean dry cloth if they become dirty Secondary cells and batteries need to be charged before use Always use the correct charger and refer to the manufacturer s instructions or equipment manual for proper charging instructions Do not leave a battery on prolonged charge when not in use After extended periods of storage it may be necessary to charge and discharge the cells or batteries several times to obtain maximum performance Secondary cells and batteries give their best performance when they are
169. ent to be printed All the measurements in between will be selected 7 Press All AJ to select all results 8 Press lt Print gt EN to print your selection 9 Records can be deleted from the database by Cas marking them and pressing Delete mi NOTE If you do not have permission to delete records the button will not be active Fig 6 12 View Control Results Operator s Manual OPTI CCA TS2 6 5 6 DATA MANAGEMENT 6 1 5 Control Statistics Reports Data gt Control Measurement Ready Y 21 47 10 Dec Date E mnnon Ena 125072 2 Kl BOL A4 LL Le Fig 6 14 Controls Statistics 6 6 The OPTI CCA TS2 allows you to print out a statistical report of the last 30 control measurements or more if available in the database 1 8 9 In the main menu select lt Data Manager gt lt Control gt In the lt Data Control Measurement gt screen press the lt Statistics gt button Fig 6 13 In the lt Data gt Control Statistics gt screen Fig 6 14 press Kl to select a lt Start gt date and lt End gt date for the statistics report to be printed Select lt Level gt and lt Lot gt Use the lt Previous gt and lt Next gt Lal buttons to display the previous or next page of measurements To print results for individual lots highlight the desired lot and level Fig 6 14
170. erformance Fig 8 40 B Lac enabled 8 32 Operator s Manual OPTI CCA TS2 8 2 21 Cassette Detect System gt Diagnostics Fig 8 41 Cassette Detect Cassette Detect Insert Patient Cassette And e Close Cover OK Cancel Fig 8 42 Insert Cassette Cassette Detect e Remove Cassette And Leave Cover Open Fig 8 43 Remove Cassette Cassette Detect Close Cover e murum Fig 8 44 Close Cover Cassette Detect e Cassette Detection Calibration Failure Fig 8 45 Calibration Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING The purpose of this test is to calibrate the Cassette Detect function In the main menu press lt System Manager gt Diagnostics gt Select the lt Tests gt tab Press lt Cassette Detect gt to start the calibration Fig 8 41 Insert a patient cassette Fig 8 42 Remove the cassette and leave the cover open Fig 8 43 Close the SMC cover Fig 8 44 The system performs a Cassette Detection Calibration Fig 8 45 8 33 8 DIAGNOSTICS AND TROUBLESHOOTING 8 3 Troubleshooting 8 3 1 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 ma
171. eview 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 TS2 ANALYTES tHb SO Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO Clinical Significance total Hemoglobin concentration 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 he
172. f whole blood The OPTI CCA TS2 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 TS2 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 TS2 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 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 Us
173. ference intervals Glu 2 Reproducibility Glu 3 SRC Limit Values Glu 2 Groups user 3 22 H Handle 1 7 Hardware settings 3 30 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 Hydrogen ion concentration 8 9 calculation A 8 reference ranges A 5 temperature corrected A 12 I Input values 8 6 A 2 Installation See Setup Interface RS232 test 7 22 Interferences 8 13 Ionized Calcium Ca clinical significance Ca 1 correlation to other methods Ca 3 interferences Ca 2 linearity Ca 3 measurement principle Ca 1 measurement range Ca 1 normalized A 13 reference intervals Ca 2 reference ranges A 5 references Ca 3 reproducibility Ca 2 unit conversion A 8 L Lactate B Lac Cassette Clinical significance Lac 1 Correlation to Other Methods Lac 4 Interferences Lac 2 Linearity Lac 4 Measurement principle Lac 1 Measurement range Lac 1 Reference intervals Lac 2 References Lac 4 Reproducibility Lac 3 SRC Limit Values Lac 2 Lactate setup 7 27 Language selecting 3 29 Last Barcode 3 10 Last Patient Info 3 10 LEDs checking 7 16 Limitations 8 12 Limits calculated 3 14 critical 3 12 measurement 3 12 Lockout New Lot 3 6 QC 3 5 SRC 3 5 M Mains supply A 6 Ma
174. 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 TS2 9 3 9 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 9 4 6 OPTI Medical ComfortSamplers Blood may be collected for analysis on the OPTI CCA TS2 with the OPTI Medical ComfortSampler to provide a filled shielded capillary tube After collection th
175. g 8 18 Insert Cassette e An optics tests will be performed to verify operation of the optical system Optics Test e Atthe completion of the test the results will be printed and you will be asked to remove the cassette Fig 8 19 Please Remove the Cassette Fig 8 19 Remove Cassette Operator s Manual OPTI CCA TS2 8 25 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 14 Checking the Ethernet Interface System gt Diagnostics The purpose of this test is to check for proper functioning of the Ethernet interface In the main menu press lt System Manager gt Diagnostics gt e Select the lt Tests gt tab e Press Ethernet to start the test Fig 8 20 Fig 8 20 Ethernet Test System gt Diagnostics gt Ethernet Ready a 12 00 10 Dec re e The system will send out data and check if they seen ree are received Fig 8 21 Duration 0 Days 00 32 29 Speed 100 Mbps IP Address 19216818135 e Press LE to return to the lt System gt screen l Activity or to return to the main menu Sent oo Received Packets 4458 5257 Fig 8 21 Ethernet Test 8 26 Operator s Manual OPTI CCA TS2 8 2 15 Checking the Pump Flow System gt Diagnostics Fig 8 22 Flow Test Insert Cassette and Close Lid Fig 8 23 Insert Cassette Testin Process Fig 8 24 Flow Test in Process Flow 3 00 6 00 PASS Fig 8 25 Flow Test Pass Please Remove the Cassette
176. g units 1 1 Analyzer components 1 3 customization 3 1 intended use 1 1 setup 2 2 Anticoagulants 5 1 accepted types 8 3 Audible alarm Beep adjustment 3 31 B Bar code scanner cleaning 7 8 scanner description 1 5 scanner troubleshooting 7 38 test 7 19 Barometric pressure entering 3 30 range A 1 unit conversion A 8 verifying 7 16 Base excess 8 9 calculation A 9 reference ranges A 5 Battery pack installing 2 2 rechargeable 1 6 Battery voltage checking 7 17 Beep adjustment 3 31 Bicarbonate actual 8 9 actual reference ranges A 5 acutal calculation A 8 standard 8 9 standard calculation A 9 standard reference ranges A 5 Blood collection and handling 5 1 8 3 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 limits 3 14 Calculated parameters 3 11 A 7 Calculated values 8 9 A 4 Calibration 4 1 8 9 report setup 3 26 tHb troubleshooting 7 37 touch screen 7 25 Capillary tubes 8 3 sample collection 5 2 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 PCO
177. ge is low Not Ready e Operate the analyzer on AC power and or Low Battery recharge the battery Data ac System Manager Manager Manager Gas 93 Battery 8 50 Baro 743 0 Operator s Manual OPTI CCA TS2 8 13 8 DIAGNOSTICS AND TROUBLESHOOTING 04 20 11 Dec lt Not Ready Battery Critical gt The battery is discharged and the instrument will not Not Ready perform any measurements Een e Install a freshly charged battery or recharge for up to 2 5 hours before the next sample is run or operate the analyzer on AC power Data ac System Manager Manager Manager Gas 93 Battery 7 9V__ Baro 743 0 lt Not Ready Temperature Out Of Range gt Not Ready The temperature is out of range e Wait for the analyzer to reach the correct temperature nl bee e Cycle the power if the analyzer does not go to Out Of Range Ready within a few minutes e Ifthe analyzer does not become Ready within a reasonable time check the temperature uM Wicca Wi under lt System Diagnostics e EE Check that ambient temperature is within EE operating specifications on page 2 1 Not Ready 04 20 11 Dec A lt Not Ready Temperature Error gt The SMC temperature is above 39 C for more than Not Ready 20 seconds Temperature rror e Press lt Data Manager gt or lt System Manager gt to exit this screen e Contact Technical Support for assistance
178. gt in the main menu 2 Inthe lt Data gt screen press the lt Diagnostics gt tab and select lt SRC gt Fig 6 18 3 Inthe lt Data SRC Diagnostics gt screen Fig 6 19 select the desired measurement and press the lt View gt button to display the measurement results Fig 6 20 4 Use the lt Previous gt and lt Next gt Le buttons to display the previous or next page of measurements 5 To print individual results highlight the desired measurement Fig 6 19 6 To print groups of results highlight the first measurement to be printed press Mark em and select the last measurement to be printed All the measurements in between will be selected 7 Press All A to select all results 8 Press lt Print gt to print your selection 9 Press K to return to the lt Data gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT 6 2 3 Controls Diagnostics Reports The lt Controls Diagnostics Report gt contains information about the measured signal in femtowatts and drifts observed during measurement Ready Y y 21 47 10 Dec Measurement Diagnostics Patient SRC 2 Inthe Data screen press the Errors Database Diagnostics tab and select Controls Fig 6 21 Fig 6 21 Select Control You can print out reports of individual control measurements groups of control measurements or all the measurements in memory 1 To
179. h 5 the cap on When prompted Fig 7 23 install the new gas bottle Insert the bottle into its housing and turn it clockwise until finger tight Fig 7 24 Press Fig 7 23 7 9 7 MAINTENANCE 7 10 7 When this display appears Fig 7 25 press to install a new gas bottle New Gas Bottle Fig 7 25 New Gas Bottle Enter Weeks Gas Bottle In Use en EM NOTE Ifyou are reinstalling a used bottle respond to the lt New Gas Bottle gt F 8 9 prompt You will then be asked to enter EN eg NEM em the number of weeks in service using the Vu ra 6 numeric keypad Fig 7 26 Here you may ee oL refer back to the installation date which was E Lal L3 recorded on the gas bottle Lal NOTE The gas bottle in use expiration is 6 months from installation or the shelf life of the gas Cancel ok bottle whichever comes first Fig 7 26 Number of Weeks in use g 17 53 04 Jan Scan Cassette Barcode e The analyzer will initiate a purge of the system which will be indicated by a progress bar displayed on the screen and will then return to pee E d the main screen Fig 7 27 Manual Entry Last Entry Data Qc System Manager Manager Manager Gas 99 Baro 737 7 XS A e se Fig 7 27 Ready screen Operator s Manual OPTI CCA TS2 7 5 2 Changing the Printer Paper Fig 7 28 Open Printer Cover Fig 7 30
180. 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 TS2 5 SAMPLE HANDLING AND PATIENT TESTING 5 3 Running A Patient Sample Whole Blood Serum and Plasma The OPTI CCA TS2 Analyzer is fast and easy to operate Whenever the lt Ready gt screen appears the unit is ready for sample measurement 1 Turn on the OPTI CCA TS2 and wait until this display appears Fig 5 1 Ready Ki 17 53 04 Jan Scan Cassette Barcode 2 Ifsecurity is enabled see Section 3 2 3 log in to the OPTI using your user ID and password Fig 5 2 e The user ID you use to log in will appear in the user ID fields on printouts and logs for G t SE Kaz all activities you perform until you log off Manual Entry Data Manager Gas 99 Baro 737 7 3 Scan the bar code on the OPTI cassette package Fig 5 1 Scan 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 5 1 Guat e The red line from the bar code scanner Loun Li should cover the entire bar code Password e A beep and a green status light indicates a k l valid bar code oK Cancel e Ared status light and error message i
181. ial 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 9 5 5 Calibration Each lot of OPTI 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 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
182. ibrator Perform Maintenance Control Setup Operator s Manual OPTI CCA TS2 Select Group Functions Time and Date Patient Entry Setup Measured Parameter Setup Patient Measurement Control Measurement SRC Measurement tHb Calibrator E Fig 3 56 Select Group Functions System gt Setup gt Security Not Ready Ki 11 47 Settings Users Groups ADMIN Users 5678 u LA Fig 3 57 User Groups 6 10 11 12 13 3 CUSTOMIZATION Scroll down for the following additional options Fig 3 56 Delete Data Time and Date Patient Entry Setup Measured Parameter Setup Calculated Parameter Setup Panel Setup Measurement Limits Setup Calculated Limits Setup Correlation Factor Setup Units Setup Hardware Setup Ethernet Setup Communications Setup Lockout Setup Language Setup Printer Setup Maintenance Setup Security Setup B Lac Setup To remove options from your list select the option and press the lt Up gt arrow Ia Press to accept the changes To add users to this group press al in the lt Users gt section in the bottom half of the screen Fig 3 57 To delete a user from a user group select the user and press the button To edit an existing user group select the group in the Group section in the top half of the screen and press wa to make the changes To delete a user group from the list select the group and press the button Press Ey
183. ice Safely eject USB Mass Storage Device Fig 6 40 Eject USB device Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT The database option will export the database to removable media when selected 1 To export the database select lt Data Manager gt in the main menu Press the lt Diagnostics gt tab and select lt Database gt Fig 6 38 Insert a USB device and select lt Export gt Fig 6 39 To remove the USB device safely touch the USB icon d in the status bar at the top of the screen Fig 6 38 You will be asked to eject the USB device safely Fig 6 40 Select to remove the device An acknowledgement screen will be displayed when it is safe to remove the device Press EJ to return to the lt Data gt screen or to return to the main menu 6 15 7 MAINTENANCE 7 MAINTENANCE eu nein 7 1 Z Daily Maintenance A X 7 1 7 2 Weekly rin ce ee 7 1 7 3 Quarterly Maintenance Performing tHb Calibration 7 2 7 4 Annual Maintenance een 7 6 PAS Replacing Pen Pump Cartridge unse ae 7 6 7 4 2 Replacing Gas O EE 7 8 7 5 As Needed Maintenance unnnssssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 7 9 1 2 1 Changing the Gas Cl TE 7 9 2 5 2 Changing the Printer Paper ee 7 11 T5 Periorming Routine ClEan iNd nnennnee ann ae eben 7 11 Operator s Manual OPTI CCA TS2 7 i 7 MAINTENANC
184. ich 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 Anemic 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 O
185. ig 3 65 Printer Configuration 3 2 4 2 Defining Units System Setup ET Fig 3 66 Select Units System gt Setup gt Units kJ 16 25 21 Mar Parameter Barometer PartialN mmHg mbarkPa Pressures Ka C c F Temperature E c 5 Low High Resolution C c Cancel Defaults Lt Fig 3 67 System Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION The OPTI CCA TS2 can be connected to an external printer In the Configuration menu Fig 3 65 you can select the printer configuration 1 Select the options to be enabled 2 Press to accept the changes 3 Press ES to return to the Setup screen or to return to the main menu This menu lets you change the units of measure for pressure temperature output resolution total hemoglobin Ca Glu BUN urea and Lac 1 Inthe main menu select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press the System tab then press Units Fig 3 66 3 In the Systeme screen select the units for the displayed parameters Fig 3 67 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 patient sample results only By default the resolution for patient samples is high Resolution is always high for Control and SRC results 3 29 3 CUSTOMIZATIO
186. ime and Date screen CUMEM EN BEI NL Fig 3 4 press LE to leave the default time eremo C5 6 and date setting unchanged or press the Time fizo button to call up a numeric keypad that can be mem GE used to change the time and date setting 5 To change the lt Time Format gt from lt 12 hour gt time units to lt 24 hour gt time units press the respective radio button Ra 6 Press to accept the changes oc 7 To log off after making the changes press the K ra L lt Log Off gt button in the bottom right Fig 3 4 Time and Date corner of the screen 8 Press ES to return to the System screen Or to return to the main menu 3 2 Setup 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 The Setup menu consists of three screens lt Patient QC gt Security and System Setup Maintenance m 1 Inthe main screen press System Manager to access the System menu Ready 2314 04 Jan 2 Press Setup to select this function Fig 3 5 Fig 3 5 Setup 3 2 Operator s Manual OPTI CCA TS2 3 21 QC Setup 3 CUSTOMIZATION 3 2 1 1 Setting up the Quality Control Material Ready 9 11 17 10 Dec Patient QC Security system r ac Lockout Customizing Patieht n m at on Patient Measured Calculated Entry Parameters Parameters Measurement
187. 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 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 TS2 cassette into the anal
188. ined 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 complementary QC methods such as the SRC Some however have not For agencies requiring a liquid QC material and for institutions requiring additional QC checks OPTI CHECK and OPTI CHECK PLUS are available These controls are specially formulated aqueous liquid control materials that contain all analytes measurable by the OPTI CCA TS2 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 different concentrations of micro beads to simulate low medium and high hemoglobin blood samples 9 10 Operator s Manual OPTI CCA TS2 9 OPERATING PRINCIPLES 9 5 7 Reference Intervals Reference intervals are useful in describing typical results found in a defined population of apparently healthy people R
189. intenance 6 1 annual 6 5 daily 6 1 log C 1 quarterly 6 1 weekly 6 1 Maintenance report 7 36 Manuals 9 2 Measured Parameters 3 10 Measurement limits 3 12 Menu structure B 1 Model and serial numbers 1 6 N New Lot Lockout 3 6 Normalized ionized calcium reference ranges A 5 Normal ranges setting 3 12 3 14 O Operating altitude A 1 Operating parameters A 2 Operating principles 8 1 Operation analyzer 8 2 Optics test 7 21 Overvoltage category A 6 Oxygen content 8 9 calculation A 10 reference ranges A 5 Oxygen partial pressure PO2 clinical significance PO2 1 correlation to other methods PO2 3 linearity PO2 3 measurement principle PO2 1 measurement range PO2 1 precision and recovery PO2 2 Operator s Manual OPTI CCA TS2 references PO2 3 reproducibility PO2 2 SRC limit values PO2 1 temperature corrected A 12 P P50 8 9 calculation A 11 reference ranges A 5 Panels test 3 16 Parameters blanking 3 10 calculated 3 11 measured 3 10 measurement ranges 1 1 A 1 reported 3 10 reporting units 1 1 Password setting up changing 3 25 Patient data 5 8 information customizing 3 7 report 5 11 testing 5 1 Patient ID 3 7 3 10 5 8 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 Reproducibili
190. ion 1 23 4567 Level 3 OPTI CHECK Sample No 2 QCLot 1234 Exp MMMYYYY Result Limits OK pH 7 601 7 580 7 620 OK PCO2 20 0 18 0 22 0 OK P02 170 0 167 0 173 0 OK Na 65 1 42 148 OK K 7 00 6 70 7 30 OK Ca 0 70 0 60 0 80 OK tHb 8 5 6 5 9 5 OK S02 98 6 96 0 100 0 OK Control Test Result PASS Store to Database Yes Barometer 734 6mmHg Operator ID Operator123 Lot 123456 MESSAGES D 4 Operator s Manual OPTI CCA TS2 APPENDIX D REPORT FORMATS Controls Statistics Report NS z HEMOGLOBIN LIMITS ge tHb 122 152 g dL a S02 870 938 Control Statistics Report DD MMM YY HH MM Date tHb S02 OK Feb4 14 2 88 6 OK ns Feb4 14 3 88 8 OK Version 1 00 0037 Feb4 14 0 88 5 OK Feb4 14 2 88 6 OK ei Feb7 14 2 88 6 OK QCLot 1278 Exp MMMYYYY ee ee eee on CassLot 250100 Mean Me eee S 3 Number run 6 2 3 Numberok 2 ADDITIONAL LIMITS AG HIS Ca 110 130 mmol L pH 7 370 7 490 PCO2 35 0 45 0 mmHg oe id aM PO2 88 0 118 0 mmHg den oK Feb4 OK Date pH PCO2 PO2 OK a ee Of Feb4 High 12 3 7153 1 N Aen Or Feb4 High 10 8 1154 7 N Feb OK Feb4 High 16 1 1148 4 N MES OK Feb4 High 14 7 1151 3 N Meats ate Feb 7 450 43 9 96 3 OK E GE Feb7 7 431 44 3 102 6 OK SS ow Mean 7 441 23 7 134 1 SD 0 013 15 9 27 0 CV 0 181 67 2 20 2 ELECTROLYTE LIMITS Na 136 0 150 0 mmol L K 4 50 5 30 mmol L Date Na K 0K Feb4 OK Feb4 OK Feb4 5 03 N Feb4 OK Feb7 OK Feb7 142 9 4 88 OK Mean
191. irty optics or cassette e Remove and discard the cassette Inspect and clean the optics glass and inside the sample measurement chamber top cover e Press to continue e Check the LEDs See Section 8 2 4 lt ERROR Calibration Expired gt The cassette has been holding the calibration for more than 10 minutes without a sample being attached This error can also be triggered if any sample is detected on the front light gate but is not a short sample like a small slug of sample e Press and discard the cassette lt ERROR Unstable Sensors gt 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 and discard the cassette e Check the sample and rerun with a new cassette lt ERROR Short Sample gt 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 aspiration and was not able to aspirate enough sample e Press and discard the cassette Operator s Manual OPTI CCA TS2 ERROR Invalid Barcode ERROR Invalid Barcode Check Time and Date ERROR Invalid Barcode Different QC Lot ERROR Expired Barcode Check Time and Date Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING ERROR Invalid Barcode The bar code was invalid The OPTI CCA TS2 either misread th
192. is Time Ambient Temperature Range Relative Humidity Range Type of Measurement Input Values A 2 Patient ID Accession Number Date of birth Patient Sex Patient Temperature Medical Record Number Account Number Test ID Patient Name Age Attending Physician Patient Location Sample Collection Time Sample Type Puncture Site Allen s Test 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 30 C 50 F 86 F 5 95 non condensing optical fluorescence for tHb SO optical absorbance reflectance 25 alphanumeric characters 25 alphanumeric characters Month DD YYYY Male female or unknown 14 0 44 0 C 57 2 111 2 F 25 alphanumeric characters 25 alphanumeric characters 25 alphanumeric characters 25 alphanumeric characters 1 150 25 alphanumeric characters 25 alphanumeric characters Month DD YYYY HH MM Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous MixVen Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass LR RR LB RB LF RF Cord Scalp where LR RR Left Radial Right Radial LB RB Left Brachial Right Brachial LF RF Left Femoral Right Femoral Cord Cord Scalp Scalp Unknown positive negative Operator s Manual OPTI CCA TS2 Hemoglobin Type Bypass O Mode Vent Mode Plate
193. is equipped with a carrying handle for easy transport which can also be used as a tilt stand to place the instrument at a convenient viewing angle for the user e To extend the handle to carrying position place the analyzer on its back and position your fingers in the cutouts on each side of the handle Push up until the handle is fully extended Fig 1 12 e To use the handle as a tilt stand pull down the handle Fig 1 13 and lock it in the lower position Fig 1 14 Turn analyzer back to original position Fig 1 15 Fig 1 13 Pull down handle N N e Fig 1 14 Tilt stand Fig 1 15 Tilt stand Operator s Manual OPTI CCA TS2 1 7 1 INTRODUCTION 1 5 Consumables 1 8 OPTI Sensor Cassette Fig 1 16 OPTI Sensor Cassette Sample Fillport and Syringe Adapter e oa N Fig 1 17 Sample Fillport and Syringe Adapter Standard Reference Cassette SRC Lot 14360005 j MULTI LEVEL SRC Exp SEP 14 BP7652 v mas Ll mom Fig 1 18 Standard Reference Cassette 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 Fig 1 16 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
194. ium 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 TS2 system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below Ca mmol L OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 1 57 1 27 0 79 Within Run St Dev S 0 01 0 01 0 01 Within Run CV 0 9 0 7 0 9 Total Precision St Dev S 0 02 0 01 0 01 Total CV 1 5 1 0 1 5 All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 ANALYTES CALCIUM Linearity Wherever possible linearity for the
195. ives If enabled vendor directives are supported Press to accept the changes Removable Media Fig 3 82 Use this option to import or export data using a USB mass storage device Select Comma or Semicolon for your CSV file delimiter in MS Excel Press to accept the changes Press E to return to the Setup screen or to return to the main menu 3 37 3 CUSTOMIZATION 3 2 4 6 Configuring Ethernet Settings System gt Setup The lt Ethernet gt screen is used to configure Ethernet settings required for discovery and set the IP address if static 1 In the main menu select System Manager and Setup 2 In the System Setup menu press the System tab and then Ethernet Fig 3 83 E vir Fig 3 83 Ethernet System gt Setup gt Ethernet Ready K 16 20 21 Mar Dynamic Static IP Type c C 3 The lt System gt Setup gt Ethernet gt menu will IP Address 255 255 255 255 u appear Fig 3 84 Subnet Mask 255 255 255 255 Discovery Port 6703 L Se ES Fig 3 84 Ethernet Settings System gt Diagnostics gt Ethernet Read 7 3 10 D m To set up Ethernet communication onnection IDE ee 1 Connect the instrument to an active network Duration D Days 00 32 29 PR en 2 Goto lt System gt Diagnostics gt Tests gt IP Address 192 168 18 135 Ethernet gt Activity m m 3 Verify that the test status is
196. l OPTI CCA TS2 A 7 APPENDIX A TECHNICAL SPECIFICATIONS 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 st pH HCO Concentration activity of hydrogen ions in plasma cH 10077 nmol L Standard pH of 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 Bicarbonate concentration in plasma _ pH 6 105 HCO 0 0307 PCO 10 mmol L 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 Operator s Manual OPTI CCA TS2 APPENDIX A TECHNICAL SPECIFICATIONS st HCO tCO BE BE BE act 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 1
197. ld calibration for 2 minutes The OPTI CCA TS2 will beep warning you when only 1 minute remains on the calibration After this time elapses a message will be displayed to discard the Patient e cassette Fig 5 9 Cassette Calibration NOTE If tHb SO has been disabled see Section 3 2 2 2 you may attach the sample at any Measuring Ki 17 55 28 Dec Cassette Calibration In Progress Please Wait time during calibration and press ox The sample will then be automatically aspirated after calibration and the measurement will begin 8 You can enter patient information while Measuring 1755 28 Dec calibration is in progress by pressing lt Patient Info gt Fig 5 10 e Press the lt Last Patient Info gt button Cassette Calibration In Progress Please Wait Fig 5 10 to use the last patient info as the PE default for the current patient information 28 if this option is enabled in lt Setup gt see Section 3 2 2 2 e This option will populate all patient info fields with the last patient data If user ID security is enabled the user ID Patient formellen kees field will contain the user ID of the user currently logged in All patient information used as the default can be edited Fig 5 10 Patient Info e Verify that patient ID and all other input parameters are correct for every patient sample measurement e Press the lt Patient Info gt button to enter new patient informa
198. le 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 TS2 PCO2 B 3 PCO Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS2 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 TS2 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 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 TS2 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 Me
199. lected 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 TS2 APPENDICES APPENDIX A TECHNICAL SPECIFICATIONS A 1 Measurement Rande nn een guns o cada OR CEU Grae Aa EURO DUM ORG A 1 Barometric Pressure A 1 Operating Altit de nn A 1 Pollution Degree m A 1 lie RE EE A 2 lee UE A 2 Temperature Corrected Values memes A 4 aei E A 5 Data Manage Meni E A 6 Mains Supply for External Power Supply ceceeeceeecceeeeeeeaaeeaaeeeaeeaaeeaaeeaeeeaeseaeeeaeeeaeeeaeees A 6 DC Supply for Instrument u een A 6 DYEVvollage Cases Meme ERR A 6 Dimensions and Weiler OT A 6 Classaticatons MEL A 7 Calculated Parameters cccccecceeeceeeceee cece a A EAEE nnn n nne n nnn n nne n nnn nnn A 7 Be e ue A 7 Units Used in Measured and Input Parameters for Calculations seeeeeseessse A 7 Conversion Table for Units ccceecceec cece cece eee eeee cece eee esas caee cee ttt EEEEEEEEEEEEEEEEEEEEEEEEE EEEE EEE A 8 Ge UE e A 8 APPENDIX B MENU STRUCTURE 2 ana de B 1 APPENDIX C MAINTENANCE LOG 22222222220022000000000nnnnnnnnnn ann nn C 1 APPENDIX D REPORT FORMATS iro prepa ns ee D 1 Basic Patient Repo
200. librator gt The cassette placed in the SMC is invalid e Verify that the cassette placed in the SMC is a valid Hb calibrator e Press to continue lt ERROR Invalid QC Lot gt The QC lot is invalid e Press to continue e Configure the control material under lt Setup gt and retry lt ERROR Need Setup QC gt A measurement of QC materials was attempted prior to setting up e Press to continue e Configure the QC material under lt Setup gt and retry lt ERROR User ID Already Exists gt The selected user ID already exists in the database e Press to continue e Enter a unique user ID lt ERROR Invalid User ID gt The user ID does not exist in current user database e Press to continue e Retry with a valid user ID ERROR User Expired The user ID expired e Press to continue e Update the user information Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING lt ERROR Passwords Don t Match gt The password entered was incorrect ERROR Passwords Dont Match e Press to continue e Enter the correct password ERROR Permission Denied gt Permission denied since user does not have access ERROR Permission Denied privileges for the selected function e Press x to continue Information on setting up user permissions can be found in Section 3 2 3 1 3 lt Range Error gt This error may occur during Hb calibration Range Error The err
201. ll patient and QC values Please make sure that all valuable data has been backed up before Password reinitialization The OPTI analyzer configuration may be downloaded and then reloaded after reinitialization to restore user IDs groups and other uaa setup options 5 1 Inthe main menu select lt System Manager gt and lt Setup gt EA 2 Inthe lt System Setup gt Security gt menu press lt Reinitialize gt Fig 3 60 een 3 Enter ADMIN user ID and password Ready E 11 52 10 Dec g i PatientiQC_ Security System 4 Amessage will be displayed asking you to confirm your choice Fig 3 61 5 Press LI to return to the lt Setup gt screen or to return to the main screen This will delete all data and reset setup data to defaults LL bA Fig 3 61 Reinitialize Operator s Manual OPTI CCA TS2 3 27 3 CUSTOMIZATION 3 2 4 3 2 4 1 3 28 Miscellaneous System Settings System gt Setup Security System Fig 3 62 Select Printer System gt Setup gt Printer Not Ready Ki 02 22 Settings y Header Configuration Ka Copies Enable 1 2 Patient Iv C Control Iv C SRC Vv Ze C Append Calibration Report ri Append Reference Limits Iv Append Critical Limits ri System gt Setup gt Printer Not Ready 02 22 Settings Header nfiguration Custom Header Enable Iv Custom Header Part 1 MERCY HOSPITAL al
202. ls Mains Supply for External Power Supply 100 10 VAC to 240 10 VAC 50 60 Hz 1 8A 10 DC Supply for Instrument 16V 10 3 75A 10 Overvoltage Category Category II when connected to a branch circuit Dimensions and Weight Height 4 7 in 12 0 cm Width 14 2 in 36 2 cm Depth 9 1 in 23 0 cm Weight Instrument 8 65 lbs 3 9 kg Battery 0 94 bs 0 42 kg A 6 Operator s Manual OPTI CCA TS2 Classifications Approvals LED Classification Mode of Operation Laser Classification Explosion Protection Calculated Parameters APPENDIX A TECHNICAL SPECIFICATIONS UL 61010 1 IEC 61010 2 IEC 61010 2 101 CAN CSA C22 2 NO 61010 1 CE FCC Class B IEC 62471 Exempt Risk Group Continuous Operation This device is a Class 1 laser device according to IEC 60825 1 This device is not designed for operation in explosive environments The calculated parameters in the OPTI CCA TS2 are based on the CLSI Standard C12 A when available Temperature rer S rec oln t T ec 32 kel 32 Units Used in Measured and Input Parameters for Calculations pH usse pH unit POCO iata mmHg PO cista mmHg Waikari mmol L e mmol L Casni mmol L CT usse mmol L Glu mmol L BUN mg dL BET mmol L SL g dL BC see Burtis AB Ashwood ER Tietz Textbook of Clinical Chemistry 2 Ed Philadelphia W B Saunders 1994 p 2165 Operator s Manua
203. ly perform sampling operations Through the touch screen you can enter patient data and initiate printing of patient QC and diagnostics 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 TS2 customization can be protected by configuring security to allow only authorized users to make changes see security section 2 3 2 The analyzer s programming or existing parameters can then be changed only by authorized users All system setup selections entered will reside in the instrument memory even after the system power is turned off 3 1 Setting Time and Date o 17 53 04 Jan Scan Cassette Barcode 1 To set the time and date press lt System Manager in the main menu Fig 3 1 Manuel Entry Data Qc Manager Manager Manager Gas 99 Baro 737 7 Fig 3 1 Select System Manager 2 Press lt Time and Date gt in the lt System gt menu Fig 3 2 Last Entry SEENEN 23 14 04 Jan 3 Enter the User ID and password factory setting ADMIN ADMIN when prompted Fig 3 3 to access the lt Time and Date gt screen EH E User ID pow 0 uj n Ey ok cancel Fig 3 2 Select Time and Date Fig 3 3 Login Password Operator s Manual OPTI CCA TS2 3 1 3 CUSTOMIZATION System gt Time and Date E 4 Inthe System T
204. m Change Password PN 31 Jan 14 31 Jan 14 NIA 3 22 e Expiration Enable allows an administrator to set an expiration date for each user ID e Logon Timeout gt When security is enabled users must log in to the analyzer When they are finished they must either log off using the lt Log Off gt button in the bottom right corner or the analyzer can be set to log off automatically after a set number of minutes of idle time The lt Users gt menu is used to set up user Identifications 1 To access this menu select lt System Manager gt Setup gt Security gt from the main menu On the lt Security gt tab press lt Settings gt Fig 3 49 Select the lt Users gt tab Fig 3 50 The default user ID is ADMIN The ADMIN user ID cannot be deleted changed and cannot expire The default password for the ADMIN user ID is ADMIN To change this password log in as ADMIN and go to Change Password in the security tab see Section 3 2 3 2 NOTE You can create another user ID with ADMIN rights if you do not wish to use ADMIN as your user ID 4 Press Ol Fig 3 50 to enter a new user to be added to the list of authorized users The analyzer can store up to 300 user IDs Operator s Manual OPTI CCA TS2 User Information User ID ize E Expiration es 1 Group uer H Reset Password Fig 3 51 User Information System gt Setup
205. 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 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 TS2 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 TS2 Analyzer take a moment to look over the contents to ensure you have the following Power supply with power cord Battery 1 Multi level Standard Reference Cassette SRC Levels 1 2 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 TS2 1 INTRODUCTION 1 4 Analyzer Components Before setting up the OPTI CCA TS2 Analyzer it is important to
206. ments 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 TS2 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 Manual OPTI CCA TS2 K 1 POTASSIUM ANALYTES Interferences The OPTI CCA TS2 K sensor has no measurable interference from Na variation within the range 100 190 mmol L The OPTI CCA TS2 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 TS2 K sensor has no interference from ammonia or ammonium ion present at normal physiologic levels below 100 pmol L At hyperammonemia plasma levels of 300 umol L the OPTI CCA TS2 KI sensor will show a potassium offset of 0 4
207. mmol L and at extreme hyperammonemia plasma levels of 3000 pmol L the OPTI CCA TS2 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 TS2 system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Controls Within run precision S and Total Precision S 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 3 different control levels are shown below K mmol L OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 2 92 4 86 5 92 Within Run St Dev S 0 03 0 03 0 03 Within Run CV 0 9 0 6 0 5 Total Precision St Dev S 0 03
208. mparative 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 slope m comparative method results intercept b PO2 B 4 Operator s Manual OPTI CCA TS2 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 c
209. mplete ru 3 Turn on the Power e Locate the power button on the left side of el the unit and push down to turn the power on dt Fig 2 3 Fig 2 3 Power Button Operator s Manual OPTI CCA TS2 2 SETUP OPTI CCA TS2 Blood gas and Electrolyte Analyzer e This is the first screen that will appear after Nv the power is turned on Fig 2 4 p OPTIMedical D Fig 2 4 Startup screen 4 Installing a New Gas Bottle Not Ready kJ 17 47 04 Jan a ayy This screen will appear after initial power up A sequence when no gas bottle is present Fig 2 5 lt gt Not Ready e Press lt New Gas Bottle gt Gas Not Installed e Open the gas bottle by unscrewing the cap New Gas Batile Data system Manager Manager ac Manager Gas 0 e The red line from the bar code scanner Baro 738 0 Fig 2 5 Select New Gas Bottle should cover the entire bar code e When prompted Fig 2 6 scan the new gas bottle bar code on the insert sheet 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 analyzer will beep when the bar code is accepted e Ifthe bar code is not recognized by the Scan Gas Barcode for New Gas Bottle scanner the first time try scanning the barcode again e Record the date of installation on the gas bottle for later reference Fig 2 6 S
210. n 7 5 1 Changing Gas Bottle e Press Ka to return to the lt System gt screen or Wal to return to the main menu 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 4 Checking the LEDs This menu can be used to check proper functioning System gt Diagnostics Bey Lu 1659 BEST ofthe LEDs and is designed for use by trained Sensors Hardware Tests Wordong E service personnel only Application a In the main menu press lt System Manager gt TPae 000C Ar bient anc Diagnostics gt op Plate J mbiei H Bi PI 0 00 C A a The following information is displayed in the 0 00 New MUN LEDs section Fig 8 5 Ir s Rear 00000 Cassette Delect Eq e Front Rear lon fluid light gates lon 00000 SMC Cover Close en 0 0 mmHg e Cassette Misseat gt detector located in Battery Voltage 0 0V Ey cover e Cassette Detect gt sensor Fig 8 5 LEDs e lt SMC Cover this function indicates whether the SMC cover is closed or open e Press 1 to return to the System screen or LA to return to the main menu 8 2 5 Verifying Barometric Pressure This menu displays the current barometric pressure 8 20 System gt Diagnostics Ready D 16 19 21 Mar In the main menu press lt System Manager gt EE Hardware JL ee Diagnostics gt Versions Bostande e The Miscellaneous section will show the ystem Ft Temperature Readings cu
211. n st pH 6 022 st HCO 10 mmol L Total concentration of CO in plasma the sum of dissolved CO and bicarbonate tCO HCO 0 0307 PCO mmol L 7 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 1 43 tHb 7 7 pH 7 4 24 8 HCO EE The base excess of extracellular fluid is a quantity that reflects only the non respiratory components of acid base balance tHb 5 g dL BE 16 2 pH 7 4 24 8 HCO mmol L Base excess at actual oxygen saturation BE 1 0 0143 tHb 1 63 tHb 9 5 pH 7 4 24 26 HCO 0 2 tHb 1 100 mmol L 7 CLSI Blood Gas and pH Analysis and Related Measurements Approved Guideline NCCLS document C46 A 2001 8 Zander R Die korrekte Bestimmung des Base Excess BE mmol l im Blut Anesthesiol Intensivmed Notfallmed Schmerzther Operator s Manual OPTI CCA TS2 A 9 APPENDIX A TECHNICAL SPECIFICATIONS BB SO c ctO 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 The oxygen hemoglobin dissociation curv
212. n 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 TS2 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 TS2 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 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
213. nalyses were analyzed by both traditional and non traditional operators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI CCA TS2 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 Analyzer 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 Se
214. nd 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 aclear 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 Control 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
215. ndicates an invalid bar code e g cassette Fig 5 2 Login expired See Chapter 8 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 code digits using the numeric keypad e Ifyou are using the same lot number of cassettes as for the previous patient sample and the lt Last Barcode Enable gt option is enabled in setup Section 3 2 2 2 you do not have to scan the cassette barcode You can press the lt Last Entry gt button Fig 5 1 instead and the cassette information will be recalled The analyzer will identify the lot number and prompt you to open the cover wipe and insert the cassette and close the cover Operator s Manual OPTI CCA TS2 5 5 5 SAMPLE HANDLING AND PATIENT TESTING Enter User ID EI E E 3 t rap Wa NN www Www NW aal a 123 Cancel OK E E F E E E 33 E d E Fig 5 3 Enter User ID Measurement gt Select Panel Ready Ki 13 29 10 Dec Select Panel to Run CALCIUM ONLY SODIUM amp POTASSIUM PH ONLY beret Lus OK Fig 5 4 Select Panel Measurement gt Select Blanking Ready Ki 13 30 10 Dec Select Sensors to Blank pH T Ca m PCO2 Glu L P02 L UrealBUN Na L Lac L K L tHb m Cl L S02 m Cancel OK Fig 5 5 Selec
216. ng 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 47 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 TS2 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 wh
217. nt 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 9 4 Operator s Manual OPTI CCA TS2 9 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 TS2 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 TS2 The OPTI CCA TS2 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 ina mL syringe to prevent mechanical interference between the syringe plunger
218. o attempt to clear the error lt STOP B Lac Setup Required gt This error message will appear if you try to run lactate cassettes and the lactate parameter has not been set up on your analyzer e Refer to section 8 2 20 for instructions to set up the lactate parameter lt STOP Temperature Out of Range gt The temperature is out of range during any kind of measurement e Press and continue e Ifthe error message appears again check the temperature under lt System Diagnostics gt Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 4 Not Ready Messages a 02 04 Not Ready Gas Not Installed e Press lt New Gas Bottle gt and reinstall the gas E gt bottle See Section 7 5 1 Data ac System Manager Manager Manager Gas 0 Baro 728 9 Not Ready za lt Not Ready Gas Not Installed gt The gas bottle is empty or has not been installed properly If you remove a gas bottle that is still valid you will have to reinstall the same gas bottle Ready 04 20 11 Dec A lt Not Ready Gas Expired gt Not Ready The in use 6 months or labeled shelf life of the gas Gas Expired bottle has expired e Press lt New Gas Bottle gt and replace the gas 077 9 bottle see Section 7 5 1 T Data ac System Manager Manager Manager Gas 93 Baro 743 0 lt Not Ready Low Battery gt The battery volta
219. od 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 TS2 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 57 127 148 102 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 TS2 Na 3 ANALYTES POTASSIUM Potassium
220. odel and Serial Numbers Back of Analyzer On the rear of the unit is Fig 1 9 USB Type B USB Type A Port yP Port m e An Ethernet port e An LED which indicates the charging status of the battery e A USB Type A port to quickly upload software and download data using a standard USB mass storage device e A USB Type B port for connection to computer Storage Compartment Port or external printer e Astorage compartment that can hold an extra Fig 1 9 Back of the OPTI CCA TS2 paper roll the SRC other supplies or accessories Fig 1 9 Battery Pack X On the left side of the unit is the rechargeable battery pack It is removed by squeezing the handle and sliding it out Fig 1 10 The battery allows you to operate the OPTI CCA TS2 without having to plug the unit into an electrical outlet The battery is charged automatically whenever the analyzer s external power supply is plugged into an electrical outlet Fig 1 10 Battery Pack Operator s Manual OPTI CCA TS2 1 INTRODUCTION Power Connector and Power Button Next to the battery pack is the power connector where you can connect the OPTI CCA TS2 to an external power supply Fig 1 11 The power button is located on the left side of the unit next to the power connector Fig 1 11 c uA NOTE To power down the system hold the power button in for 2 seconds e Fig 1 11 Power Connector and Power Button Carrying Handle The OPTI CCA TS2
221. 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 TS2 Ca 3 ANALYTES CHLORIDE Chloride Cr 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 concentration 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 CT 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 fluores
222. of unit and surface to prevent unit overheating NOTE Above requirements also apply when the OPTI CCA TS2 operates on battery power outside a laboratory setting Operator s Manual OPTI CCA TS2 2 1 2 SETUP 2 3 Setting up the OPTI CCA TS2 Analyzer 2 2 You are now ready to prepare your OPTI CCA TS2 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 es 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 TS2 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 emm e Push the battery pack into the opening on the left hand side of the OPTI CCA TS2 A Fig 2 2 NOTE The battery will need to be charged a RK 3 for at least 2 5 hours prior to using the OPTI CCA TS2 on battery power It will be charged automatically whenever the analyzer 5 external power Fig 2 2 Insert Battery Pack supply is plugged into an electrical outlet The lower LED on the back of the analyzer turns green while the battery is being charged The top LED turns green when charging is co
223. ofactor 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 acidosis 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 opto
224. ol levels are shown below Dry pH OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 7 168 7 418 7 632 Within Run St Dev S 0 011 0 008 0 007 Within Run 9o CV 0 2 0 1 0 1 Total Precision St Dev S 0 015 0 011 0 011 Total CV 0 2 0 1 0 1 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 CV 0 12 0 10 0 14 n 18 18 18 Linearity Wherever possible linearity for the OPTI CCA TS2 measurement has been established 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 TS2 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 TS2 pH B 3 pH Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS2 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
225. ollowing the CLSI guideline EP5 A2 Typical results for 3 different control levels are shown below Na mmol L OPTI Check Level 1 OPTI Check Level 2 OPTI Check Level 3 Days Run 20 20 20 Total Average 126 1 143 7 156 5 Within Run St Dev S 0 6 0 7 0 4 Within Run CV 0 4 0 5 0 3 Total Precision St Dev S 0 7 0 7 0 6 Total CV 0 6 0 5 0 4 Na 2 Operator s Manual OPTI CCA TS2 ANALYTES SODIUM All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Chapter 4 5 OC Recommendations 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 TS2 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 Correlation Slope Intercept Coefficient Sy x Range n Sodium 0 9788 2 456 0 99911 1 32 104 188 30 Sodium sr 1 0172 3 244 0 99957 0 55 121 161 18 Correlation to Other Methods OPTI CCA TS2 vs other pH Blood Gas Instruments on whole blo
226. on lets you check the battery voltage In the main menu press System Manager gt Diagnostics e The second display in the Miscellaneous section shows the battery voltage Fig 8 7 e Ifthe voltage is below 9 0V the battery needs to be recharged or may need replacement e Press bb to return to the lt System gt screen or to return to the main menu The purpose of this test is to check for proper functioning of the cooling fan In the main menu press lt System Manager gt Diagnostics gt e Select the Hardware tab e Press the On button under Fan to start the test Fig 8 8 e You should feel the draft of the fan by placing your hand over the fan at the back side of the analyzer e Press E9 to return to the System screen Or to return to the main menu 8 21 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 8 Checking the Gas Valve System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Gas Valve Open Closed Ze C r Fan On Off Lol C Cassette Valve Drive E Position O k ken uii i Fig 8 9 Gas Valve 8 2 9 Checking the Valve Drive System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Fan r Gas Valve On Off Open Closed Ze C Ze C Cassette Valve Drive Position By x W KN Fig 8 10 Valve Drive 8 22 The purpose of this test is to check for proper function of the gas valve
227. ontraction cardiac function transmission of nerve impulses and blood clotting The OPTI CCA TS2 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 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 is 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 u
228. oon WARNING Hb Calibration expires soon WARNING Hb Calibrator expires soon WARNING New tHb Calibrator lt WARNING Check Pump gt The peristaltic pump is getting worn e Remove the cassette e Retry with a new cassette e Change the peristaltic pump cartridge See Section 7 4 1 lt WARNING SRC expires soon gt The SRC will expire in four weeks e Press to continue Make sure you have more SRCs on hand or ordered lt WARNING New SRC Lot gt This message is displayed to alert the user that a new SRC lot is being used e Press to continue measurement with the new SRC lt WARNING Hb Calibration expires soon gt The Hb calibration will expire in four weeks e Press to continue lt WARNING Hb Calibrator expires soon gt The Hb Calibrator cassette will expire in four weeks e Press to continue Make sure you have another Calibrator Cassette on hand or ordered lt WARNING New tHb Calibrator gt This message is displayed to alert the user that a new tHb calibrator is being used e Press to continue measurement with the new tHb calibrator Operator s Manual OPTI CCA TS2 B Lac Setup WARNING Control Failed Rerun Control Patient Info WARNING Required Fields Missing Data WARNING Text Length Less Than Minimum Characters Required Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING lt WARNING Control Failed
229. options that cannot be combined based on the cassette configurations available from OPTI Medical 4 Press to add a new test panel Fig 3 37 5 Inthe subsequent screen Fig 3 38 press LA and enter a name for the test panel Select the parameters to be included in the panel 6 Press to accept the settings 3 17 3 CUSTOMIZATION Systems setip Panel 7 To edit an existing panel select the panel Not Ready Fig 3 39 and press La Enable Iv DEFAULT 8 Press Lit to delete an existing panel The default panel cannot be edited or deleted SODIUM amp POTASSIUM 9 Use the lt Up gt E3 and Down ES arrows to reorder the panels in the list 10 Use the Previous and Next Lal buttons to display the previous or next page of panel configurations Lt SC 11 Press Ka to return to the lt Setup gt screen or Fig 3 39 Panels to return to the main menu 3 18 Operator s Manual OPTI CCA TS2 3 2 2 7 Setting up Correlation Factors System gt Setup Ready Ki 11 17 10 Dec Patient ac Security System r ac Control Lockout Customizing Patient Information Measured Calculated Y Parameters Parameters Measurement Calculated Limits Limits aia Fig 3 40 Select Correlation System gt Setup gt Correlation Not Ready 11 40 10 Dec Factors 1 Factors 2 Slope Offset pH 1 000 0 000 wa pco2 1000 i oo ka
230. or is triggered when the correction is greater than 10 e Press and replace the Hb calibrator lt ERROR Not enough records in Level 2 gt There are not enough records in the database to generate a statistics report e Press to continue ERROR Not enough records in Level 2 lt ERROR Group Name Already Exists gt ERROR Group Name Already Exists The selected group name already exists in the database e Press a _ to continue e Enter a unique group name Operator s Manual OPTI CCA TS2 8 11 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 3 System Stop Messages STOP Optics Module Error Cycle Power for Reset STOP Cassette Valve Error Cycle Power for Reset STOP Dark Currents Error Cycle Power for Reset STOP Barometer Error Cycle Power for Reset B Lac Setup oa STOP B Lac Setup Required STOP Temperature Out of Range 8 12 STOP Optics Module Error gt Optics Module Error detected when reading optics data e Turn the power off and back on STOP Cassette Valve Error The cassette valve failed to f nd the home position e Shut down the system and restart to attempt to clear the error STOP Dark Currents Error gt Dark currents exceed allowable limits e Shut down the system and restart to attempt to clear the error lt STOP Barometer Error gt The barometer reading is outside the measurement range e Shut down the system and restart t
231. orn 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 t 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 to 40 0 01 mmol L Operator s Manual OPTI CCA TS2 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 2 0 5 10 0 5 25 0 5 mmol L Interferences The OPTI CCA TS2 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 pmol L At extreme hyperammonemia plasma levels of 3000umol L the OPTI CCA TS2 BUN urea sensor will show an offset of 4 8 mg dL BUN 1 7 mmol L urea Reproducibility Controls Within run precision S and Total Precision S were determined from 2 runs per day with 2 replicates per run over a period of 10 days following the CLSI guideline EP5 A2 Typical results for 3 different
232. ove the cassette Fig 5 7 After opening Cassette the pouch proceed with the following steps immediately NOTE The cassette should be run immediately after opening the pouch but no later than 2 minutes 1 minute for B Lac Cassettes after opening NOTE For sample introduction with a capillary tube or a ComfortSampler remove the syringe adapter before placing the cassette into the chamber Fig 5 7 Insert Cassette e Gently wipe both sides of the cassette with a clean dry cloth to remove excess moisture Measurement e Insert the cassette in the chamber Measuring Press down to ensure the cassette is properly SORE MENT seated Fig 5 7 e Close the SMC cover by pressing it down firmly Fig 5 8 e The green status light starts to blink indicating that the SMC cover should not be opened during this time NOTE 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 Fig 5 8 Close Cover Operator s Manual OPTI CCA TS2 5 7 5 SAMPLE HANDLING AND PATIENT TESTING 7 The system will now check the integrity of the cassette and then calibrate Fig 5 9 For more information about calibration please refer to Chapter 4 Calibration and Quality Control NOTE The OPTI CCA TS2 will hold calibration Calibrating for 10 minutes for all cassette types except NEN s B Lac B Lac cassettes will ho
233. p OPTIMedical mp 185 215 g dL DEE S02 68 0 72 8 RC Statistics Report an Date tHb S02 OK Feb4 20 0 70 0 OK Feb4 19 9 69 9 OK i ben Dass Feb4 19 9 69 9 OK ds Feb4 20 0 70 0 OK ER Feb7 20 0 70 0 OK Feb7 19 9 70 0 OK MMMYYYY SRCID 12345678 Exp er SD 01 01 Number run 6 Number ok 6 SES 0 3 0 3 ADDITIONAL LIMITS ABG LIMITS pH 1 080 7 120 Ca 1 70 1 90 mmol L PCO2 68 0 72 0 mmHg Date Ca OK PO2 57 0 63 0 mmHg En Ge Date pH PCO2 PO2 OK dire 2 SR Feb4 7 120 67 8 59 3 OK den iu n Feb4 7120 72 2 59 7 OK nn iu Ge Feb4 7 110 69 8 58 7 OK ae iu ok Feb4 7 100 69 2 58 6 OK ao Feb 7 070 67 8 58 8 OK E m Feb7 7 080 673 573 OK D leah Mean 7 107 70 0 56 6 SD 0 015 19 17 oa 0210 28 3 0 METABOLITES l Glu 36 0 44 0 mg dL ELECTROLYTE LIMITS oe no m amp i Na 123 0 1270 mmol L a Ae mmol 2 20 2 VL i dde Ste Date Glu BUN Lactate OK EE Feb4 1 00 OK Date Na K Cl OK de un Feb4 5 6 1 00 OK Feb4 125 0 2 50 OK Feb 40 0 5 6 1 00 OK Feb4 125 0 2 50 OK Feb 40 0 5 6 1 00 OK Feb4 125 0 2 50 OK Feb 40 0 5 6 1 00 OK Feb4 125 0 2 50 OK Mean 40 0 5 6 1 00 Feb7 125 0 2 50 OK SD 0 2 0 0 0 00 Feb7 125 0 2 50 79 8 OK Do 51 3 050 Mean 125 0 2 50 0 0 i SD 000 0 0 00 0 0 CV 000 0 0 00 0 0 Operator s Manual OPTI CCA TS2 D 3 APPENDIX D REPORT FORMATS Controls Measurement Report E Ca example De OPTIMedical OPTI CCA TS2 Controls Measurement DD MMM YY HH MM S N 123 Vers
234. played on the screen LEM um Once the warm up is complete the Ready display appears Fig 2 10 LECH Manager Gas 99 Baro 737 7 Fig 2 10 Ready screen 2 4 Operator s Manual OPTI CCA TS2 Fig 2 12 Install Printer Paper x ud Fig 2 13 Close Printer Cover Operator s Manual OPTI CCA TS2 2 SETUP Installing the Printer Paper e Press the red printer release button on the printer cover to access the printer Fig 2 11 e Place the roll of printer paper into the paper tray e Pull the end of the paper upward and slightly out of the paper tray Fig 2 12 e Hold the paper and close the printer cover Fig 2 13 e The paper will automatically feed through as the printer starts printing 2 5 2 SETUP 6 Performing tHb Calibration Ready 17 53 04 Jan Scan Casseite Barcode The tHb Calibrator Cassette should be run prior to patient testing when first setting up your de gt gt analyzer The tHb calibrator should then be run every three months Your OPTI CCA TS2 will t an remind you when the tHb calibration is due The tHb Calibrator Cassette can be found in Let Ep the storage compartment in the back of your Data Qc System analyzer Manage Manager Manager e Inthe lt Ready gt display scan the bottom en bar code on the calibrator cassette package by holding it 2 3 inches 5 8 cm from the Fig 2 14 Sc
235. ples 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 9 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 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
236. 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 TS2 Operator s Manual l Guilbault GG Ed Practical Fluorescence 2nd Ed Marcel Dekker 1990 Operator s Manual OPTI CCA TS2 9 1 9 OPERATING PRINCIPLES 9 3 Operation The OPTI CCA TS2 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 after equilibrating with the blood sample After a single measurement the cassette containing the blood sample is removed from the analyzer and discarded The analy
237. poventilation 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 I I 1 1075H 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 measur
238. print a Controls Diagnostics Report select Data Manager in the main menu 3 In the Data Control Diagnostics screen Fig 6 22 select the desired measurement and press the View button to display the measurement results Fig 6 23 4 Usethe Previous and Next buttons to display the previous or next page of measurements Data Control Diagnostics 3 2 10 Dec 12 5 To print individual results highlight the desired d measurement Fig 6 22 Lal e OZ L Lal 6 To print groups of results highlight the first fil id measurement to be printed press lt Mark gt EEE and select the last measurement to be printed oe a All the measurements in between will be selected E A u e U 7 Press lt All gt to select all results Para w ort T w et 2m aras100l sa a 1024 8 Press Print to print your selection PCO2 3206860 63 2 32 102 8 9 Press Es to return to the lt Data gt screen or PO2 3922160 14 8 22 109 0 Na 2569880 29 6 28 104 6 K 3406660 6 2 22 104 0 Ca 1553690 2 2 18 101 8 hd Wi e Fig 6 23 Control Diagnostics Operator s Manual OPTI CCA TS2 to return to the main menu 6 9 6 DATA MANAGEMENT 6 2 4 Error Report 6 10 Ready T 21 47 10 Dec Measurement Diagnostics Patient SRC Database Rue
239. ptics Clean Cassette Optics WARNING Gas expires soon WARNING Gas Test Power Must be Cycled to Abort Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING e For all other cassettes press to continue The results for the defective sensor will not be provided lt WARNING Bubble Detected gt A bubble was detected at the light gates e Remove the cassette e Press to continue e Examine the cassette and look for bubbles If bubbles are present over a sensor rerun the patient or QC sample lt WARNING Dirty Optics gt 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 to rerun the test WARNING Gas expires soon The gas bottle will expire in four weeks e Press to continue Make sure you have another gas bottle on hand or ordered NOTE The gas bottle expires 6 months after installation or after exceeding the labeled expiration date whichever comes first lt WARNING Gas Test gt The lt Gas Test gt is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system This test will last 2 hours and can only be interrupted by switching the analyzer off e Press to cancel this test 8 3 8 DIAGNOSTICS AND TROUBLESHOOTING WARNING Check Pump Please Remove Cassette WARNING SRC expires s
240. rage of SAMOS E 5 3 5 1 8 Test Conditions eee 5 4 52 sample E E 5 4 52 1 Whole Blood Samples nenne ea 5 4 5 3 Running A Patient Sample uunn0nnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnnnnnnnnnnnnnnnnnnnen 5 5 Operator s Manual OPTI CCA TS2 5 i 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING The OPTI CCA TS2 Analyzer provides fast and convenient measurement of pH PCO PO Nat K Ca Cl Glucose BUN urea Lactate tHb and SO in whole blood and pH Na K Ca Cl 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 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 5
241. rnet S t lt ASTM H d h ki gt e elec andsnaking IP Address 0 0 0 0 g me E None all data is sent without an ee acknowledgement None Single Full 2 Lol Single communication is established and all data is sent in a single message with acknowledgment cance Defauts save Full communication is established Ey and each record is sent separately with an acknowledgement Fig 3 80 ASTM Ethernet J e Press to accept the changes 3 36 Operator s Manual OPTI CCA TS2 System gt Setup gt Communications Ready Ki 16 19 21 Mar Protocol POCT1A Ethernet IP Address 0 0 0 0 Port 6700 wa POCT Mode Synchronous Patient List D Operator List ri Vendor Directives O ba concer netus JE save Kata Fig 3 81 POCT1AEthernet System Setup Communications Ready E 16 19 21 Mar Protocol Removable Media Removable Media comma Delimiter comme x E ws Fig 3 82 Removable Med ia Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION lt POCT1AEthernet gt Fig 3 81 Make the following selections IP Address IP address of host computer Port Communication port number POCT Mode Continuous or Synchronous Patient List If enabled the patient list is sent from remote computer Operator List If enabled the Operator IDs are sent from remote computer Vendor Direct
242. rrent barometric pressure Fig 8 6 Top Plate 0 00C Ambient ooc Bottom Plate 0 00C Gas Level Gas Pressure Low 0 00 New LEDs Front 0 0000 Cassette Misseat No Rear 0 0000 Cassette Detect 0 0000 lon 0 0000 SMC Cover Closed Miscellaneous Barometric Pressure 0 0 mmHg Battery Voltage 00v ES Fig 8 6 Barometric Pressure If the barometric pressure requires adjustment refer to Setup Section 3 2 4 4 1 Entering the Barometric Pressure for setting the barometer Press Ka to return to the lt System gt screen rl A to return to the main menu Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 6 Checking the Battery Voltage System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Versions Application Bootloader System Temperature Readings Top Plate 0 00C Ambient 00C Bottom Plate 0 00 C Gas Level Gas Pressure Low 0 00 New LEDs 4 Front 0 0000 Cassette Misseat No Rear 0 0000 Cassette Detect 0 0000 lon 0 0000 SMC Cover Closed Miscellaneous Barometric Pressure 0 0 mmHg Battery Voltage 00v E Ere Fig 8 7 Battery Voltage 8 2 7 Checking the Cooling Fan System gt Diagnostics Ready Ki 16 19 21 Mar Sensors Hardware Tests Gas Valve Open Closed Ze C Fig 8 8 Cooling Fan Operator s Manual OPTI CCA TS2 This selecti
243. rt the test Fig 8 30 e Touch the screen and a dot should appear under the touched location Fig 8 31 e Ifnot press lt Calibrate gt to perform a touch calibration 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 8 32 NOTE Do not use sharp objects since they may damage the screen e When finished press D see e Press 1 to return to the System screen Or to return to the main menu 8 29 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 19 Gas Test System gt Diagnostics Ready Ss 16 19 Sensors Hardware keen eeose Tests Display Touch w s KO Fig 8 33 Gas Test WARNING Gas Test Power Must be Cycled to Abort ien buffen Fig 8 34 Gas Test 8 30 The lt Gas Test gt Fig 8 33 is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system NOTE This test will last 2 hours It can only be interrupted by switching the analyzer off e Press to cancel this test Fig 8 34 Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 20 Setting up the B Lac Cassette System gt Diagnostics Sensors Hardware Barcode Fig 8 35 B Lac Setup Enter User ID luca Lei d kel kel Lal kal La ai Lal kel Wo t E d bs Le Ln Lg
244. s Fig 6 30 NOTE Data will be exported using the setting selected in the Communications Setup see Section 3 2 4 5 3 Select the data to be exported and press Export to start the data transfer Fig 6 31 Operator s Manual OPTI CCA TS2 Export data Fig 6 32 Export Selected Data Not Ready 11 09 27 Dec Controls Miscellaneous Reports Configuration Maintenance Lt Fig 6 33 Eject USB device Eject USB Mass USB Mass Storage Device Safely eject USB Mass Storage Device Fig 6 34 Eject USB device Operator s Manual OPTI CCA TS2 6 DATA MANAGEMENT A message will be displayed asking you to confirm your choice Fig 6 32 After exporting to a USB device touch the USB icon d in the status bar at the top of the screen or the button lt Eject USB Mass Storage Device gt to remove the USB device safely Fig 6 33 You will be asked to eject the USB device safely Fig 6 34 Select to remove the device An acknowledgement screen will be displayed when it is safe to remove the device Press E to return to the Data screen or to return to the main menu 6 13 6 DATA MANAGEMENT 6 4 2 Exporting Configuration Data 6 14 Miscellaneous Reports Not Ready Y 11 09 27 Dec Measurement Diagnostics Patient SRC Eject USB Mass ren Storage Device Maintenance Configuration
245. s 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 TS2 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 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 L I 1 kP which describes how the fluorescence emission intensity I
246. s 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 O 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 TS2 PO2 B 3 PO Dry Sensor ANALYTES Correlation to Other Methods OPTI CCA TS2 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 TS2 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 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 TS2 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 Co
247. se 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 TS2 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 8 0 1 1 1 0 1 0 7 0 1 mmol L Operator s Manual OPTI CCA TS2 Ca 1 CALCIUM ANALYTES Interferences The OPTI CCA TS2 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 Sod
248. selected 7 Press All rt to select all results 8 Press Print to print your selection 9 Records can be deleted from the database by marking them and pressing Delete ama NOTE If you do not have permission to delete records the button will not be active 6 3 6 DATA MANAGEMENT 6 1 3 SRC Statistics Reports The OPTI CCA TS2 allows you to print out the statistics ofthe most recent 30 days of SRC C iR 10 Dec 12 measurements for all levels JLR1212 10 Dec 12 JLR12121 1 Inthe main menu select lt Data Manager gt lt SRC gt 2 Inthe Data SRC Measurement screen press the lt Statistics gt button Fig 6 8 Fig 6 8 SRC Statistics 3 Inthe lt Data gt SRC Statistics gt screen Fig 6 9 press LZ to select a lt Start gt date and End date for the statistics report to be printed Data gt SRC Statistics LINEA W ENETUN EDIIS 4 Select Level and Lot Start End Immonz K i 127072 ka 5 Use the Previous _ and Next Le us 3r buttons to display the previous or next page of measurements 6 To print results for individual lots highlight the desired lot Fig 6 9 7 To print groups of results highlight the first lot aa sj to be printed press lt Mark gt Le then select EA the last lot to be printed All the lot numbers in between will be selected Fig 6 9 SRC Statistics 8 Press
249. spiration 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 For more information including detailed instructions on the tHb calibration see Section 7 3 Quarterly Maintenance in this manual Operator s Manual OPTI CCA TS2 4 1 4 CALIBRATION AND QUALITY CONTROL 4 2 4 3 4 2 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 An effective Quality Control program should include e evaluation of precision over the entire analytical range e an assessment of failure modes a
250. st be discarded 15 You can again enter patient information while measurement is in progress by pressing lt Patient Info gt Fig 5 14 Please follow the steps for patient data entry described under calibration on p 5 8 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 If the screen has not been touched for approximately three 3 minutes the lt Measurement Results gt will automatically be displayed Fig 5 15 NOTE The printout will start automatically when the first results are displayed This feature may be turned off in setup See Section 3 2 4 1 NOTE If ASTM POCTI or removable media is enabled the results will not be printed until the user exits the measurement process The data will also be exported when it is printed Additional information on printing reports and exporting data can be found in Chapter 6 Data Management Operator s Manual OPTI CCA TS2 Measurement gt Results Measuring E 13 34 10 Dec Measured Calculated Calibration tCO2 HCO3 stHCO3 Hct c E Fig 5 16 Calculated results Measurement gt Results Measuring Measured Calculated Calibratio Limits 7 412 7 426 39 8 41 8 90 7 94 7 149 0 151
251. sted 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 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 TS2 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 precision S and Total Precision S 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 3 different contr
252. sured 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 TS2 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 amount 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 TS2 system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Reproducibility Controls Within run precision S and Total Precision S were determined from 2 runs per day with 2 replicates per run over a period of 20 days f
253. 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 TS2 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 TS2 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 0 087 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 Ga
254. t 7 24 Q QC overview 4 2 recommendations 4 3 setup 4 4 QC Lockout 3 5 QC Sample running 4 9 QC Setup 3 3 3 38 Quality control 4 1 8 10 R Ranges normal 3 12 Reference intervals 8 11 Reinitialization system 3 25 Reported Parameters 3 10 Report formats D 1 Reports Configuration D 6 Control 4 15 Controls Measurement D 4 Controls Statistics D 5 Diagnostic 7 30 Error D 9 D 10 Maintenance D 8 Patient D 1 SRC 4 8 SRC Measurement D 2 SRC Statistics D 3 Routine cleaning performing 6 10 S Sample collection devices 5 1 8 3 handling and storage 5 3 8 4 preparation 5 4 requirements 5 1 8 3 whole blood 5 4 Sample fillport description 1 8 Sample measurement chamber SMC description 1 4 Security setting up 3 19 INDEX Sensor cassette description 1 8 Setup analyzer 2 1 QC 3 3 3 38 system 3 2 Shutdown 3 32 Sodium Na Na l 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 Na 1 Spare parts 9 3 Specimen collection and handling 5 1 8 3 SRC Lockout 3 5 SRC Measurement running 4 4 SRC reports printing 4 8 Standard pH 8 9 calculation A 8 reference ranges A 5 Standard Reference Cassette SRC 1 8 Standby 3 32 Status light description 1 4 Storage compartment 1 6 Supplies 9 1 Symbol definitions VII Syringe adapter description 1 8 Syringes 5 2 8 3 T Te
255. t Sensors 5 6 During warm up the OPTI CCA TS2 checks the gas pressure Once it reaches 5 or less the value will be displayed in red Ifthe pressure is too low a warning will appear asking you to install a new gas bottle see Section 7 5 1 Ifa gas bottle has not been properly installed the gas pressure value will also be displayed in red If Non Secure User ID Entry is enabled in the security settings see Section 3 2 3 you will be asked to enter the user ID Fig 5 3 NOTE Bar coded user IDs may be entered from this screen using the bar code scanner If customized test panels have been set up in lt Setup gt see Section 3 2 2 6 the lt Select Panel gt screen Fig 5 4 will appear and display a list of available panels Select the desired panel and press o If Allow Blanking gt has been enabled in Setup see Section 3 2 2 2 the Select Sensors to Blank screen Fig 5 5 will be displayed and give you the option to suppress the results for certain parameters for the current measurement Select the desired parameters and press Operator s Manual OPTI CCA TS2 5 SAMPLE HANDLING AND PATIENT TESTING Measurement Measuring Open Cover 5 Press down on the red latch to open the Sample Measurement Chamber SMC Fig 5 6 Fig 5 6 Open SMC Cover 6 Insert the cassette as follows Measurement Measuring e Open the OPTI Sensor Cassette pouch and Open Pouch and Wipe rem
256. t for assistance lt Fatal Error Dark Currents gt Dark currents exceed allowable limits e Shut down the system and restart to attempt to clear the error e Ifthe error cannot be cleared by cycling the power contact Technical Support for assistance Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING lt Fatal Error Optics gt Failure detected in optics system Fatal Error Optics Shut down the system and restart to attempt to clear the error e Ifthe error cannot be cleared by cycling the power contact Technical Support for assistance Data ac System Manager anager Manager Gas 93 Baro 743 0 Not Ready K Exception lt Exception gt FP 0x80A7619A SP 0x00002570 PC 0x00000000 LR 0x80000018 Processor exception occurred CPSR 0x60000013 R4 0x00000015 RS 0x00000000 R6 0x80807E9C a T e Press to exit the screen and contact Technical Support for assistance Data ac System Manager Manager Manager Gas 99 rey Baro 729 3 Operator s Manual OPTI CCA TS2 8 17 8 DIAGNOSTICS AND TROUBLESHOOTING 8 2 Diagnostics Your OPTI CCA TS2 has a number of useful Ready a 23 14 04 Jan diagnostic programs Time and Date Diagnostics In the main menu press System Manager gt Diagnostics Fig 8 1 Ji The Diagnostics screen contains three tabs m with various diagnostic functions
257. t security setting is lt Non secure User ID Entry gt Fig 3 47 In this mode the analyzer will request a user ID before patient testing QC testing maintenance activities and running an Hb calibrator This mode will not verify a user ID and does not require programming of user IDs or groups In this mode some activities will still be protected by the ADMIN password such as changing the time and date and the security setup menu lt Secure User ID Entry gt Fig 3 48 will enable the option to set up secure user IDs and create groups of users with certain privileges This option must be selected to enable passwords and user ID expiration When this option is enabled users will be asked to log in to the OPTI before they can perform any operations The OPTI will verify the login and only allow the user to perform duties assigned to that user Logins can be by user ID only The user ID can be entered by bar code scanner for easy access Once logged in the OPTI will enter the user ID for all activities performed by the user automatically e For added security you can enable passwords by selecting lt Password Enable gt When users first log in to the OPTI they will be asked to enter a password system default PASSWORD For future login they will be required to enter user ID and password 3 21 3 CUSTOMIZATION 3 2 3 1 2 Setting up User IDs System gt Setup Ready Ki 01 56 19 Dec PatientiQC Security Syste
258. tein 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 TS2 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 TS2 9 13 9 OPERATING PRINCIPLES 9 5 11 Accessories 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 tH
259. the sample is properly attached and not clotted and does not contain air bubbles e Wait for the system to recalibrate Aspiration e Remix the sample carefully WARNING No Sample Detected e Ifthe system does not detect the sample after retrying press to notify the system that the sample is reattached and reaspirate sample lt WARNING Unstable pH gt The displayed measured parameter is unstable WARNING Unstable pH NOTE This message is a warning The analyzer will however display a result for the parameter concerned e For lactate cassettes you have the option of continuing the measurement by pressing e 5 WARNING Unstable pH or stopping by pressing e For all other cassettes press to continue e Once the measurement is complete remove cassette and check for aspirated bubbles e Ifbubbles are present over a sensor do not report that parameter lt WARNING Bad Sensor pH gt The displayed sensor is defective WARNING Bad Sensor pH e For lactate cassettes you have the option of continuing the measurement by pressing ce or stopping by pressing se If you continue no results will be provided for the defective sensor or any calculated result which utilizes this measurement in its calculation 8 2 Operator s Manual OPTI CCA TS2 WARNING Bad Sensor pH Aspiration WARNING Bubble Detected Check Cassette Calibration WARNING Dirty O
260. thod 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 TS2 ANALYTES PO 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 PO 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 m
261. tion or to not use the last patient info as the default 5 8 Operator s Manual OPTI CCA TS2 Measurement gt Patient Data Measuring 5 13 31 10 Dec Patient ID Accession Number DOB Sex wa Unknown Temperature 370C k LE wc Fig 5 11 Edit Patient Data Measurement Measuring Mix and Place the Sample Fig 5 12 Mix and place sample Operator s Manual OPTI CCA TS2 5 SAMPLE HANDLING AND PATIENT TESTING The Patient Data entry screen Fig 5 11 contains the information that was configured in Setup Section 3 2 2 1 The following options are set by default Patient ID 25 alphanumeric characters Accession No 25 alphanumeric characters Date of Birth DOB Temperature default value 37 0 C Sex unknown male or female NOTE Patient IDs and Accession Nos may be 10 11 entered from this screen using the bar code scanner To enter patient data press a Fig 5 11 Use the alphanumeric keypad to type in the desired information Pressing will access subsequent patient data entry screens if configured in Setup Section 3 2 2 1 NOTE If patient data parameters have been set up as Required you will not be able to exit the Results screen until that information has been entered 12 Press 1 when you are finished editing 13 patient info After the successful calibration the status light will stop blinking and the displa
262. to return to the lt Setup gt screen or Standby Enable Shutdown Enable r1 to return to the main menu Standby Timeout Shutdown Timeout e Lo e CAUTION Use the absolute barometric pressure zen oetans E sme and not the altitude corrected pressure kid A check with your local weather service or airport Fig 3 72 Barometric pressure NOTE You may change barometric pressure units from mmHg to mbar See section 3 2 4 2 NOTE You should check the barometric pressure periodically 3 32 Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 2 4 4 2 Beep Adjustment System gt Setup gt Hardware This option lets you adjust the volume of the audible Read 21 Mar m LI alarm Beep Barometer Current Offset P QUNM 0n LJ 1 Inthe main menu select lt System Manager gt Beep Enable Vv and lt Setu p gt High Low EN 2 Inthe lt System Setup gt menu press the StandbyEnable Shutdown Enable lt System gt tab and then lt Hardware gt F 5 3 Select lt Beep Enable gt Fig 3 73 Standby Timeout Shutdown Timeout Eu E 4 Select lt High gt or Low for lt Beep Cancel Defauts B Save Volume gt Ka 5 Press to accept the changes Fig 3 73 Enable Beep 6 Press to return to the lt Setup gt screen or to return to the main menu Operator s Manual OPTI CCA TS2 3 33 3 CUSTOMIZATION 3 2 4 4 3 Standby 3 34
263. to return to the lt Setup gt screen or to return to the main screen Operator s Manual OPTI CCA TS2 3 25 3 CUSTOMIZATION 3 2 3 2 Setting up a Password 3 26 Ready o 01 56 19 Dec Patient QC Security System fl Lei Fig 3 58 Change Password Change Password Password Re enter password Es Cancel OK Fig 3 59 Enter Password The OPTI CCA TS2 has a password function which when activated will deny access to the setup menus and certain database functions The factory default user ID and password is ADMIN The factory set password can be changed to any number letter combination up to 25 alphanumeric characters 1 In the main menu select System Manager and lt Setup gt 2 On the Security tab press Change Password Fig 3 58 NOTE This function is only active if security is enabled and the user is logged in 3 Press LZ to enter the new password Fig 3 59 4 Retype the password and press to accept the changes CAUTION Make sure the password is kept confidential and in a safe place Passwords can not be retrieved 5 Press Ey to return to the lt Setup gt screen or to return to the main screen Operator s Manual OPTI CCA TS2 3 CUSTOMIZATION 3 2 3 3 System Reinitialization System gt Setup Reinitializing the system returns all programmed TREE m to their factory set default values and eletes a
264. tte lt ERROR B Lac Setup failed gt This error message appears when the reproducibility of the OPTI Check controls during the lactate setup procedure is out of range e Repeat lactate setup procedure Make sure to aspirate the OPTI Check directly from the ampoule e Repeat the lactate setup using a different lactate cassette lot e Call Technical Support ERROR Wrong Different Lot An incorrect cassette type or lot was scanned in during B Lac setup e Allcassettes used during lactate setup must be the same lot number e Make sure the cassette type is B Lac Operator s Manual OPTI CCA TS2 ERROR Cassette Misseat 1 Re insert Cassette ERROR Cassette Misseat 2 Re insert Cassette ERROR Cassette Misseat 2 Discard Cassette ERROR Bad Cassette Discard Cassette Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING lt ERROR Cassette Misseat 1 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 ERROR Cassette Misseat 2 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 to use a different cassette Make sure to wipe the new cassette dry before inserting
265. 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 TS2 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 30 C 50 86 F Relative Humidity 5 to 95 non condensing Type of Measurement optical fluorescence pH PO PCO Na K Ca CT Glucose BUN urea Lactate 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 CAUTION Whole blood 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 CAUTION Sedimentation of red cells may occur rapidly in whole
266. ty PCO2 B 3 SRC limit values PCO2 B 1 Peristaltic pump cartridge description 1 5 replacing 6 5 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 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 Power button 1 7 Power connector 1 7 Power Supply connecting 2 2 Principles of operation 1 1 Principles of procedure 8 1 Printer description 1 5 setting up 3 26 test 7 20 Printer paper changing 6 9 installing 2 6 Proficiency testing 4 2 Protocol communications 3 33 Pump flow checking 7 23 Operator s Manual OPTI CCA TS2 INDEX Pump motor tes
267. ue 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 Hypoglycaemia 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 TS2 Glu 1 GLUCOSE ANALYTES Measurement Principle The glucose optode measurement is based on the enzymatic oxidation of glucose Glucose 0 gluconic acid H O glucose oxidase The sensor is constructed of an enzyme layer over an ox
268. uey 20 pue ejeq nuayy Apeoy B 1 Operator s Manual OPTI CCA TS2 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 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 TS2 C 1 APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Basic Patient Report ABG example Ye OPTIMedical HEMOGLOBIN OXYGEN STATUS tHb 0 g dL OPTI CCA TS2 S02 96 Patient Report Hec oo DD MMM YY HH MM ENTERED PARAMETERS PATIENT INFORMATION Pplat 62 0 Patient ID Mvol VE 50 L FG34567 PIP 6 Accession Number Liter Flow 165 00 Lpm 5678912 Tvol VT 50 mL Medical Record Number PS 49 0 00541698 PEEP 19 Test ID Rate f 60 bpm BLOOD GAS CPAP 61 DOB 25 Jan 1985 tHb 15 0 g dL
269. w samples and are the system default settings based on the OPTI Medical QC recommendations 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 These materials should provide target values for all 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 levels 1 and 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 TS2 4 3 4 CALIBRATION AND QUALITY CONTROL 4 5 1 Running an SRC Measurement OPTI Medical Systems recommends running levels 1 and 3 high and low values of the Standard Reference Cassette SRC as a daily quality control for the OPTI CCA TS2 analyzer Scan SRC Barcode 1 Inthe main menu scan the bottom bar code on the SRC pack
270. wer Supply EI7020 Power Cord EX0197 Power Cord Schuko EX0173 Seal SMC Gas I O Port RE7030 10 8 Technical Assistance Most often problems with your OPTI CCA TS2 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 instrument downtime is minimized Operator s Manual OPTI CCA TS2 10 3 10 SUPPLIES 10 9 Warranty Registration U S Market Only After successful completion of the installation of your new OPTI CCA TS2 complete the enclosed nstallation 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 TS2 are on the bottom panel of the unit Pl
271. with ET a soft lint free cloth Fig 2 17 J Press Fig 2 17 Clean Optics Measuring 22 44 04 Jan Open Cover e Open the SMC cover by pressing down on the red latch Fig 2 18 Fig 2 18 Open Cover Measuring Insert Cassette e 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 19 Fig 2 19 Wipe and Insert Cassette Operator s Manual OPTI CCA TS2 2 7 2 SETUP Measuring Close Cover e Close the sample chamber cover Fig 2 20 e After the cover has been closed the E SES instrument will automatically detect the presence of the calibrator cassette and begin Measuring calibration Fig 2 21 Im oe Fig 2 21 tHb Calibration Measuring e After the calibration is complete you will be tHb Calibration in Progress prompted to open the sample chamber cover and remove the cassette Fig 2 22 SCENE NE CANARIE 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 Fig 2 22 Remove Calibrator 2 8 Operator s Manual OPTI CCA TS2 we gt OPTIMedical OPTI CCA TS2 HbCal Report DD MMM YY HH MM S N XXXX Version X XX XXXX User ID User 123 HbCal LOT XXXXXX
272. y for the OPTI CCA TS2 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 0 993 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 TS2 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 TS2 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 Els
273. y get clogged or dirty causing the tHb and SO to fail calibration or OPTI Check controls The simple cleaning procedure below can be used for OPTI CCA TS2 analyzers and may correct tHb and SO failures 1 Open the SMC cover and locate the two small optical channels pictured below Fig 8 46 Fig 8 46 Locate Optical Channels 2 Clean the optical channels using a cotton swab or lint free cloth dipped in alcohol or ammonia based cleaner Fig 8 47 Fig 8 47 Clean Optical Channels Please contact OPTI Medical Technical Support for any additional questions or information regarding this procedure 8 34 Operator s Manual OPTI CCA TS2 8 DIAGNOSTICS AND TROUBLESHOOTING 8 3 2 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 Operator s Manual OPTI CCA TS2 8 35 9 OPERATING PRINCIPLES 9 OPERATING PRINCIPLES 2 9 1 91 intended Use nee 9 1 92 Principles OF Procedure u 9 1 93 u 01 1 0 c ERS eee een REG REDE eaa eee ee eee 9 2 9 4 Specimen Collection and Handling ecce 9 3 GE a NEE 9 3 9 4 2 Sample Requirements sss nennen nennen nennt nennen nnn 9 3 9 4
274. y representatives will gladly provide any assistance you may require Description Part Number 10 1 Analyzer OPTI CCA TS2 Analyzer GD7046 with Accessory Kit 10 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 10 3 Controls Calibrators Multi level Standard Reference Cassette SRC BP7652 OPTI CHECK Trilevel HC7008 OPTI CHECK PLUS Trilevel HC7009 tHb Calibrator Cassette BP7653 Operator s Manual OPTI CCA TS2 10 1 10 SUPPLIES Description Part Number 10 4 Consumable Items Printer Paper 1 roll HP0070 Calibration Gas Bottle BP7162 Capillary Tubes 250 pcs MC0024 ComfortSampler with Accessories BP0600 ComfortSampler Basic Kit BP0610 ComfortSampler Bulk w Needle BP0620 ComfortSampler Bulk w o Needle BP0630 ComfortSampler Bulk Needle w Protector BP0640 10 5 Accessories Battery Assembly EI7019 Case Carrying YB7025 Assembly Wand Touch Screen BP7145 10 6 Manuals CD Operator s Manual PD7300 Operator s Manual PD7301 10 2 Operator s Manual OPTI CCA TS2 10 SUPPLIES Description Part Number 10 7 Spare Parts Peripump Cartridge Kit BP7012 Po
275. y will prompt you to mix and place the sample Fig 5 12 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 14 Attach the sample to the cassette fillport using a syringe and adapter capillary or ComfortSampler and press Fig 5 12 e When using a syringe make sure the red syringe adapter is not touching the syringe plunger 5 9 5 SAMPLE HANDLING AND PATIENT TESTING 5 10 X OPTIMedical Fig 5 13 Attach Capillary Measuring Ki 17 55 28 Dec Cassette Measurement In Progress Please Wait Measuring 2 B past patientinfo Fig 5 14 Sample Measurement Measurement gt Results Measured Calculated Calibration pH N 848 PCO2 Low PO2 163 1 mmHg Nat 1160 3 mmol L K 15 28 mmollL Ca 1 22 mmollL tHb SO2 Fig 5 15 Measurement results e When using capillary tubes push the tube firmly into the fillport Fig 5 13 WARNING Do not inject the sample It will be aspirated automatically e The sample will then be aspirated and measured Fig 5 14 During the measurement the status light is blinking and a progress bar is displayed e Do not open the cover of the sample measurement chamber during the measurement If you do the cassette and the sample mu
276. yed e When a value for any measured parameter can not be determined 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 5 11 6 DATA MANAGEMENT 6 DATA MANAGEMENT 5 5 2 een 6 1 6 1 Printing Measurement and Statistics Reports nnnnnnsssnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 6 1 6 1 1 Patient Measurement Reports eiris srie E N ER ES 6 1 6 1 2 SRC Measurement Reports ENNEN 6 3 6 1 3 SRC Statistics Reports 2 0 02 cece cece cece cece cee eeee cece cece eee ee cae e cee eeee nennen nennen nennen nennen nennen 6 4 6 1 4 Control Measurement Heports nennen nennen nnne 6 5 0 1 5 Control Statistics E EE coo vette ain ee 6 6 6 2 Printing Diagnostics Reports nase 6 7 6 21 Patient Diagnostics Repars e uneeanenee e andetinu aa 6 7 6 2 2 SRC Di gnostics Reports IC 6 8 6 2 3 Controls Diagnostics Reports 6 9 024 t EITOETSODOIT EE 6 10 6 3 Miscellaneous Reports nenn aan 6 11 6 3 1 Maintenance Report 6 11 6 4 Importng Exporting Dala une ae 6 12 6 4 1 Exporting Measurement Data ee aa 6 12 6 4 2 oup ie oim 6 14 6 4 3 Exporting Ihe Database MT
277. ygen 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 TS2 Glu sensor does exhibit an interference from oxalate and EDTA at the levels used for anticoagulants Heparin salts are therefore the only acceptable anticoagulants The OPTI CCA TS2 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 TS2 ANALYTES GLUCOSE Reproducibility Controls Within run precision S and Total Precision S were determined from 2 runs per day with 2 replicates per run over a period of 10 days following the CLSI guideline EP5 A2 Typical results for 3 different control levels are shown below Glucos
278. yzer 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 TS2 The OPTI CCA TS2 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 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
279. yzer to operation System errors are stored in memory and an error report can be printed see Section 6 2 4 If your OPTI CCA TS2 does not perform correctly after conducting the basic steps outlined in this chapter you should contact OPTI Medical Systems for technical assistance 8 1 System Error and Warning Messages The OPTI CCA TS2 displays the following types of system status messages SYSTEM WARNING MESSAGES e System warning messages notify the operator of conditions requiring operator intervention to complete the current measurement SYSTEM ERROR MESSAGES e These errors occur during sample analysis and are specific to the current sample being analyzed Error alarms indicate the status of the current measurement or additional required operator entry SYSTEM STOP MESSAGES e These alarms indicate system conditions that must be resolved before system operation can be continued NOT READY MESSAGES e These alarms indicate system conditions that must be resolved before system operation can resume FATAL ERROR MESSAGES e These errors indicate conditions that halt system operation and may require instrument repair Contact Technical Support for assistance Operator s Manual OPTI CCA TS2 8 1 8 DIAGNOSTICS AND TROUBLESHOOTING 8 1 1 System Warning Messages lt WARNING No Sample Detected gt Aspiration R The sensors did not detect any sample WARNING No Sample Detected e Make sure
280. zer 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 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

OPTI™CCA-TS2 Analyzer - OPTI Medical Systems

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OPTI&trade;CCA-TS2 Analyzer - OPTI Medical Systems

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OPTI™CCA-TS2 Analyzer - OPTI Medical Systems