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OPTI™ R Analyzer - OPTI Medical Systems

1. 7 23 AE EEE ee eee eee en eee ee 1 24 1 2 14 Checking the Pump Motor EEE RR E 7 25 17 2 15 Checking the DNs 7 25 7210 Checking the Touch STEEN BE 7 26 7 2 17 Checking the RS232 Interface 7 27 7 2 18 Checking the Ethernet Intertace ccc ccccccceceeeecececeeeeceeeceueeseeessueeseuseseeeseneeseeesees 7 28 7 2 19 Checking the Pump ENEE 7 29 Operator s Manual OPTI R Analyzer II TABLE OF CONTENTS 220 FINGEREN 7 30 i222 DET RENE 7 31 1 2 21 1 Patient Diagnostic e ha ae raa C uu VA 7 31 2 21 2 Auto QC Diagnostic Report EE 7 32 REG de Diagnostic Repor RR EE panes 7 33 72 214 Calibration Diagnostic FR DONT Lenes Farina ddmd 1 34 E E A E e EE 7 35 22 15 VNR Mener 7 36 L Oe te ee e Ia e EE 7 37 1 3 1 Fluidics Troubleshooting EEN 1 37 732 Clog Removal EE 7 39 r e Repair ENN 7 40 o4 NFOUDICSHOOUMG Procedure TOR ele E 7 41 7 4 Troubleshooting Procedure for Bar Code Scanner 7 42 8 OPERATING PRINCIPLES ME 8 1 8 1 Intended EE 8 1 8 2 Principles of Procedure rx nnrannnnvnnnnnnnnnnnnnnnunnnnnnnnnunnnnnnnnnunnnnnnnnnunnnnnnennunnunnneene 8 1 Geet TN 8 2 8 4 Specimen Collection and Handling s 8 3 NR 8 3 8 4 2 SERENA 8 3 8 4 3 Anticoagulants and Sample Collection Devices rrrnrrrnnrrnnrrnranennnrrnnnrnnnnnrnnrnnannnnnennnnnn 8 3 EE SSE 8 3 045 Oapilar LUES 8 3 8 4 6 OPTI Medical Comfo
2. me wma es 1 mem X ge k Statistics Up Fy Home Fig 4 39 Export Data WARNING Export Selected Data Yes No Fig 4 40 Export Selected Data Operator s Manual OPTI R Analyzer The OPTI R 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 R communication port must be configured See section 3 3 2 8 and a physical connection to the receiving computer must be made Before exporting to the Compact Flash CF Card included in CF Export Kit BP7140 make sure that the Compact Flash card is properly inserted in the CF port 1 In the Ready display select lt Data Manager gt 2 Select Patient lt AutoQC gt Controls or lt Calibration gt Fig 4 38 3 Select the data to be exported and press wrt to start the data transfer Fig 4 39 4 A warning will be displayed asking you to confirm your choice Fig 4 40 4 CALIBRATION AND QUALITY CONTROL 4 6 Calibration System gt Utilities Not Ready 10 40 12 Mav Installation Utilities Calibrator Run Master Calibration Power Control Powerdown ShutDown Om ai Up Lo Home Fig 4 41 Master Calibration 4 18 The analyzer will perform a calibration verification every 30 minutes and after each measurement You may however perform a master calibration at any time by selecting lt Mast
3. 2 1 2 3 Setting Up the OPTI R Analyzer nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnennn 2 2 Operator s Manual OPTI R Analyzer 2 i 2 SETUP 2 SETUP 2 1 Important Safety Instructions Before you begin installing your OPTI R 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 R 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 R Cassette and Fluid Pack 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 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 of un
4. Operator s Manual OPTI R Analyzer Calibrator Report OPTI Medical OPTI R Calibrator Report DD MMM YY HH MM S N XXXX Version ABCX XX Operator ID HbCal LOT XXXXXX DD MMM YY HbCal Date Calibration Results Meas d Cal d tHb 124 9o02 7 14 6 Calibration F ctors OLD 023 061 089 000 000 RI F2 F3 FA F5 Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Configuration Report Part 1 NOTE The values and settings shown are for example purposes only Please refer to your particular analyzer configuration report for its correct values and settings D 10 OPTI Medical OPTI R Configuration Report DD MMM YY HH MM S N XXXX Version ABCX XX Baro Offset 0 000 Patient Info Pat ID ON Opt Oper ID ON Opt Acc Num ON Opt DOB ON Temp ON Sex ON Hb Type ON Controls Info Lev 1 LimMin pH TIPO Tig AZ PCO2 64 0 78 0 PO2 57 0 81 0 Na 118 0 128 K 2 20 3 20 Ca 1 44 1 74 LED 17 9 21 9 502 1640 86 40 LimMax 0 mmHg mmHg Ommol L mmol L mmol L g dL gt o OC hot Lev 2 pH PCO2 PO2 Na 9169 Exp Janz010 LimMin LimMax fa 380 7 460 40 0 48 0 mmHg 88 0 11250 mmHg 140 0 150 0 mmol L Sample Type ON tHb MCHC 02 Mode EIOZ ON ON ON K 4 00 4 80 Cart Ns D tHb 12287158 502 86 0 792 9 mmol L mmol L g dL o RO ON P50 ON Vent Mode ON TVol
5. Tid Cancel Fig 6 62 Remove Cassette Syste m gt Utilities gt Shutdown Not Ready After the cassette has been removed you will be asked to remove the gas bottle Fig 6 63 14 Unscrew the gas bottle by turning the knob on the bottom counterclockwise Cancel Fig 6 63 Remove gas bottle Syste m gt Utilities gt Shutdown Not Ready System Shut Down Complete 15 When the shutdown is complete Fig 6 64 Turn off Instrument turn the system power off Fig 6 64 Turn off instrument Operator s Manual OPTI R Analyzer 6 23 7 DIAGNOSTICS AND TROUBLESHOOTING 7 DIAGNOSTICS AND TROUBLESHOOTING 7 1 7 4 Error RTE e VC 7 1 Te Reine TE 7 16 Tel Checking NNN 7 16 7 2 2 Checking System Temperatures cccccccccececeececseeceeeecseecececaeeccaaeceeeeseeesoueesaeesees 7 17 gt Checking the LEDS 7 17 7 2 4 Verifying Barometric Pressure annannnnnnnnnennnnnnernnnnnnrrenrnnrrnnrnnrrnnrnrrnnnrnnererrenrenrrnrrne 7 18 7 2 5 Checking Consumable Levels ccccccccscccesceceeceececeeeeseeceueeseeeseueesaueesaeessueesaeesees 7 18 E Checking the MF 7 19 m Checking cl cT Tn 7 19 7 2 8 Checking the Factory Settings ccccccccccccssceceseeeeeceeeeceeeceueeseeesseeseueesaeeseueeseesees 7 20 729 Checking the Valve DIVE rc casse dide Seed 7 20 7 210 Checking the Bar Code Scanner deed deeg Ee eege 7 21 Totes A Ch
6. mponent Installation Cm D SE i Repeat Pack Gas Bottle Install Q3 up Zo Home Fig 6 27 Installing new Fluid Pack Syste m gt Utilitles New Pack Installation Insert Fluid Pack Cancel Fig 6 28 Insert OPTI R Fluid Pack 6 10 The OPTI R Fluid Pack is designed for 100 150 measurements When this display appears Fig 6 26 the Fluid Pack is empty and needs replacement 1 Incase the Fluid Pack is low press lt New Fluid Pack gt 2 Otherwise go to lt System Manager gt Utilities gt and press lt Fluid Pack gt on the lt Installation gt tab Fig 6 27 3 Remove the old Fluid Pack from the fluid pack compartment on the rear of the analyzer and install the red protective connector strip 4 Record the installation date on the label of the new pack 5 Remove the protective strip and insert the new OPTI R Fluid Pack in the compartment on the rear of the analyzer Fig 6 28 CAUTION When used the OPTI R Fluid Pack contains human body fluids and must be treated as medical waste Handle with appropriate care and dispose of in accordance with local regulations Operator s Manual OPTI R Analyzer New Component Checks Not Ready 10 40 12 Nov Completed Conditioning si am Master Cal 5 AOC Level 3 fe AQC Level 2 r AQC Level 1 E Master Cal 8 Fig 6 29 New Component Check Operator s Manual OPTI R Analyzer 6 MAINTENANCE As soon as
7. CAUTION This will cause the gas bottle to drain quickly e Press Q UP screen to return to the System 7 19 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 8 Checking the Factory Settings System gt Diagnostics Not Ready 10 40 12 Mov Control Page 3 of 5 Fig 7 9 Factory Settings 7 2 9 Checking the Valve Drive System gt Diagnostics Not Ready 10 40 12 Nov Cassette Valve Drive Page 4 of 5 Cassette Valve Drive Position Position Position Position Oe C Ed a g x Lat Bi C 10 sb zt 1 ga w 8 32 C 4 Back Next Q ve e Home Fig 7 10 Valve Drive 7 20 This lt Fset gt function Fig 7 9 is designed exclusively for use by authorized OPTI Medical personnel This diagnostic checks the proper operation of the cassette valve drive mechanism From the lt Ready gt display press lt System Manager gt Diagnostics gt In the lt Diagnostics Sensors gt screen press Next repeatedly to access the Cassette Valve Drive gt screen Page 4 of 5 e Select position and then position 0 e Observe and verify that a 360 degree rotation of the valve drive occurs smoothly and precisely Fig 7 10 NOTE The valve drive is located in the SMC e Press Q UP to return to the System screen Operator s Manual OPTI R Analyzer System gt Diagnostics Not Ready 10 40 12 Mov Tests Page 5of 5 c Printer Optics Gas Test
8. Status Light Fig 1 3 Status Light Sample Measurement Chamber SMC e ER 3 orn m p ema a Fig 1 4 Open SMC Cover The analyzer activities are communicated to you through a backlit VGA screen displaying the activities of the analyzer sample results and other relevant information You communicate with the analyzer through a graphical user interface The graphic interface is a touch screen used to perform all analyzer functions Fig 1 2 To the right of the display is a two color status light Fig 1 3 During operation you will see one of the following e Green Light System is ready for measurement e Blinking Green Light System is in process of calibration or measurement Do not open the cover e Red Light Major error has occurred system has stopped e Blinking Red Light System has encountered a problem and needs operator interaction before it will proceed Inside the top of the unit is the Sample Measurement Chamber SMC for the OPTI R Cassette To open the cover slide the latch up and press the release button The cover will then pop up Fig 1 4 Several LEDs and two infrared lasers are located inside the sample measuring chamber Operator s Manual OPTI R Analyzer 1 INTRODUCTION Bar Code Scanner The bar code scanner on the right side of the instrument reads lot expiration information and QC ranges if applicable from cassettes controls and gas b
9. Controls Statistics Report OPTI Medical OPTI R Controls Statistics DD MMM YY HH MM tHb Lasn Losa GOZ STU So Level 2 OPTI check QCLOt XXXX Exp MMMYY CassLot XXXXXX S N XXXX Number run Number ok ABG LIMITS pH 1 500 7 470 PCO2 40 0 48 0 mmHg PO 06 0 gt 110 0 mmHg Core LAN Date Catt 04May 1 24 04May 1 20 Date pH PCOZ POZ OK 04May 7 412 43 9 04May 7 410 43 5 05May 7 410 05May 1 22 Mean Papa 33 SD 0 002 i CV SE EK Electrolyte Limits Na 139 0 149 0 mmol L K 4 40 5 20 mmol L Date Nat K OK 04May 143 9 4 76 OK 04May 143 6 4 74 OK 05May 143 Operator s Manual OPTI R Analyzer HEMOGLOBIN LIMITS ADDITIONAL LIMITS mmol L OR OK Patient Measurement Calibration Report OPTI Medical OPTI R Calibration Report DD MMM YY HH MM RESULT pH Teo PCOZ2 6948 PO2 99 8 Nat 144 2 K 4 46 Ca 1 10 tHb 14 7 502 98 3 LIMITS feo Db 65 15 26 1095 142 148 4 0 4 8 Luk 124 0 15 5 OK 96 99 OK Control Test Result PASS Barometer 744 5 mmHg S N 1L234 Totyvi123456 Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Patient Diagnostics Calibration Report D 8 OPTI Medical OPTI R Calibration Reports DD MMM YY 16 08 S N XXXX Version ABCX XX DDMMMYY 15 56 CassLot XXXXXX PackLot XXXXXX mV prodr T pH 116 ef EN pet 101 0 19 poz 2955 3 L5 Na 116 s 1 7 K 209 19
10. OPTI R Analyzer A 7 APPENDIX A TECHNICAL SPECIFICATIONS Units Used in Measured and Input Parameters for Calculations DE sense pH unit FOO E mmHg FO cien mmHg la E mmol L Conversion Table for Units ctO O ct tCO tHb barometric pressure PCO PO ionized Calcium Ca Equations cH mmol L Ca senn mmol L MB er g dL ME MM I vol 1 ml dl 0 4464 mmol l 1 g dl 10 g l 0 6206 mmol l I mmHg 1 3333 mbar 0 1333 kPa I mmol L 4 008 mg dL 2mEq L Concentration activity of hydrogen ions in plasma cH 2100779 st pH 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 Burtis AB Ashwood ER Tietz Textbook of Clinical Chemistry 2 Ed Philadelphia W B Saunders 1994 p 46 6 Marsoner HJ Quantities and Algorithms Related to Blood Gas and Acid Base Analysis AVL Medizintechnik Graz 1995 A 8 Operator s Manual OPTI R Analyzer HCO APPENDIX A TECHNICAL SPECIFICATIONS Bicarbonate concentration in plasma EI pH 6 105 HCO 0 0307 PCO 10 mmol L st HCO tCO BE BE ecf Standard bicarbonate of the blood defined as the plasma bicarbonate concentration in blood which has been equilibrated at 37 C with a gas mixtur
11. System gt Diagnostics Not Ready 10 40 12 Mov Tests Page 5 of 5 Barcode Printer Optics Touch R5232 Ethemet Print Emor Flow Test Report Back ES Next Q Up Ca Home Fig 7 22 Display Test Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The purpose of this test is to check the proper functioning of the peristaltic pump motor From the Ready display press System Manager gt Diagnostics gt In the Diagnostics Sensors gt screen press et repeatedly to access the Tests screen Page 5 of 5 e Press Pumps to start the test Fig 7 20 e The pump will automatically step through all the speeds used during normal operation 50 to 800 pps pulses per second Fig 7 21 and return to the lt Tests gt screen The purpose of this test is to check the proper operation of the display From the Ready display press System Manager gt lt Diagnostics gt In the lt Diagnostics Sensors gt screen press Cg Next repeatedly to access the Tests screen Page 5 of 5 e Press Display to start the test Fig 7 22 e The display will turn red green and blue If this is not the case your display is defective and needs to be replaced e Press Up to return to the System screen 7 25 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 16 Checking the Touch Screen System gt Diagnostics Not Ready 10 40 12 Nov Test
12. Valve 5 3 Back Einem e Fig 7 7 Cooling Fan 7 2 7 Checking Valves System gt Diagnostics Not Ready 10 40 Control Fig 7 8 Valves Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The purpose of this test is to check for proper functioning of the cooling fan From the lt Ready gt display press lt System Manager gt Diagnostics gt In the Diagnostics Sensors screen press Next to access lt Consumable Status gt then press NX again to access the lt Control gt screen e Select lt On gt or lt Off gt next to lt Fan gt to start the test Fig 7 7 e When On is selected you should feel the draft of the fan by placing your hand over the fan at the back side of the analyzer e Press UP to return to the System screen The purpose of this test is to check for proper function of the gas and buffer valves From the Ready display press System Manager gt Diagnostics gt In the lt Diagnostics Sensors gt screen press QNet to access lt Consumable Status then press QjNex again to access the Control screen e Select Open or Closed for the following valves Fig 7 8 0 Wash buffer I Gas valve 2 QC Solution L1 3 QC Solution L2 4 QC Solution L3 5 Gas select valve e A faint hissing sound may be heard if valve 1 and valve 5 are opened at the same time and no cassette is present
13. and Chapter 5 Patient Testing 3 2 Setting Time and Date 1 Inthe main menu press lt System Manager Fig 3 1 to access the lt System gt menu e Press lt Time and Date gt Fig 3 2 e Enter the password factory setting 404 when prompted to access the lt System gt Time and Date gt screen Fig 3 3 Measurement System gt Time and Date Ready 10 40 12 Nov Not Ready 10 40 12 Nov Not Ready 10 40 12 Nov eam Time Format ra Time and Date Diagnostics m Time Edit a d Gas p TT 50 Date 4g Edi Baro 7324 Setup Utilities Automatically Adjust for Daylight Savings I Next Event 05 16 Run Sample Daylight Savings Enable mue um Manager Manager Manager ance S Fig 3 1 Select System Manager Fig 3 2 Select Time and Date Fig 3 3 Time and Date Samples 50 Start Sample Pack Measurement 83 Operator s Manual OPTI R Analyzer 3 1 3 CUSTOMIZATION System gt Time and Date Not Ready 10 40 12 Nov Time Format M oa Time Edit Date Edit Automatically Adjust for Daylight Savings Daylight Savings Enable a cancel pl sae Se sm Fig 3 4 Time and Date 3 3 Setup 3 2 Not Ready 10 40 12 Nov Time and Date Diagnostics ed arms Fig 3 5 Setup In the lt System gt Time and Date gt screen Fig 3 4 press Up to leave the default time and date setting unchanged or press th
14. is the difference between the alveolar oxygen tension estimated above and the measured oxygen tension of arterial blood PAO P oa 47 FIO PACO FIO 1 FIO J R mmHg PACO PaCO alveolar PCO Apply above equation for PAO 2 PO otherwise PAO PO pH corrected to patient temperature other than 37 C pH pH 0 0147 0 0065 pH 7 4 t 37 IpH unit 7 Concentration of hydrogen ions corrected to patient temperature other than 37 C cH 10 9 9 nmol L 6 PCO value corrected to patient temperature other than 37 C PCO PCO 10919137 mmHg PO value corrected to patient temperature other than 37 C 5 491011 P023 88 0 071 t 9 721079 P093 88 2 30 1 37 PO PO 10 mmHg Operator s Manual OPTI R Analyzer APPENDIX A TECHNICAL SPECIFICATIONS AaDO Alveolar to arterial oxygen tension difference corrected to patient temperature other than 37 C AaDO PAO PaO mmHg where PAO P PH O FIO PACO FIO 1 FIO R with PH Ot 47 1010 0237 0 0001 t 37 t 37 2 and PACO PaCO alveolar PCO arterial PCO Apply above equation for PAO 2 PO otherwise PAO PO total Hct c Hct c as a function of tHb Het c tHb g dl MCHC 100 yo 1 Where MCHC is the Mean Cell Hemoglobin Concentration representing the average concentration by weight of hemoglobin inside the avera
15. menu select Utilities Fig 6 1 3 In the Utilities menu select lt Calibrator Run Fig 6 2 Calibrator Master Calibration Run Power Control Powerdown ShutDown Q ve Ta tiome Fig 6 2 Select Calibrator Run Operator s Manual OPTI R Analyzer 6 1 6 MAINTENANCE Enter Password Fig 6 3 Enter Password Enter Operator ID HARARE i ea ce a oe a S pe ala SEE Ei E EE Jajaja LEEREN Space Fig 6 4 Enter Operator ID Enter Lot Number Cancel OK Fig 6 5 Enter Lot Number 4 Use the numeric keypad to enter the password Fig 6 3 5 Use the alphanumeric keypad to enter the Operator ID or press ok to bypass this function Fig 6 4 s If Secure Op IDs is activated under Setup see Section 3 3 2 4 3 your 4 digit PIN will be required in place of your Operator ID 6 Enter the lot number of the Calibrator cassette located on the top surface of the cassette and press ok Fig 6 5 Operator s Manual OPTI R Analyzer 6 MAINTENANCE Syste m gt Utilities gt Calibrator Not Ready 7 Atthe prompt open the SMC cover by pressing OPP the button Fig 6 6 Cancel Fig 6 6 Open Cover Optics H 8 Gently clean the optics window and the inside Clean Optics and top cover of the sample chamber with a soft lint INT eee free cloth Fig 6 7 Press ok x Fig 6 7 Clean Optics and Inside of Cover Syste m gt Utilit
16. 2 In the System Setup menu press Hardware to select this function Fig 3 30 3 Inthe lt Settings gt menu press Edit to enter an offset from the true barometric pressure Fig 3 31 4 Type in the new numbers and press fl Save to accept the value 5 Press Q UP to return to the Setup screen or f Home to return to Ready CAUTION Use the absolute barometric pressure and not the altitude corrected pressure check with your local weather service or airport 3 15 3 CUSTOMIZATION 3 3 2 7 Beep Adjustment This option lets you adjust the volume of the audible Systen Setup Hardware alarm Beep Settings Interface Ethernet l From the Ready display select Barometer Current Offset lt gt lt gt Barometer Guren E System Manager and Setup Heep Enable r l Beep Volume 10 60 l Backlight Auto off OR Min Min Mode e c gg cane el Defaults f Save Q ve fire gt Fig 3 32 Enable Beep 6 3 3 2 8 Automatic Backlight Function In the lt System Setup gt menu press lt Hardware gt In the lt Settings gt screen select lt Beep Enable gt Fig 3 32 Select lt High gt or lt Low gt for lt Beep Volume Press Fale to accept the changes amp UP to return to the lt Setu p screen or f Home to return to lt Ready gt Press In this menu you can enable the automatic backlight System gt Setup gt Har
17. 4 5 1 QC Setup 4 5 1 1 Setting up Auto QC The OPTI R Analyzer is factory preset to perform an automatic QC measurement in the Auto QC mode every 8 hours To change the Auto QC settings Run Kar Ss 1 Select lt QC Manager gt in the lt Ready gt display 2 Select lt Auto QC gt under lt SETUP gt Ready 10 40 12 Nov s n Fig 4 1 cn eet Q ve Home Fig 4 1 Select Auto QC Auto QC Scheduler 1 In the Setup gt Auto QC screen Fig 4 2 select a time slot and enter the time at which ED you want the analyzer to perform the control ei we ME s ss measurements amp 2 16 00 Edit B m C aa get r rr 2 Select the levels to be measured 4 f Edit 5 L F as saj r rr 3 Select the days of the week to run Auto QC Enable M T W Th F Sa Su 5 st qf imp jm mp m mi sm 4 Press FS to save the changes or press Gask Page rors gen Qa Next to move to page 2 of Auto QC setup Qo B NOTE The OPTI R will automatically run AQC form level 1 and level 3 once a day to check the Q Up integrity of the cassette These two levels Fig 4 2 Select Auto QC Time will be run even if Auto QC is disabled and Level 5 Press Q UP to return to the Setup screen OT f Home to return to lt Ready gt 4 4 Operator s Manual OPTI R Analyzer Level E C Range Range pH Edi e e PCO2 de e C PO2 Edit e e Fig 4 3 Adjust Auto QC Ranges QC g
18. E ERROR Invalid Barcode Check Time and Date OK E ERROR Expired Barcode Check Time and Date K Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The sample cannot be analyzed because one or more sensors do not yield a valid optics signal e Re run sample make sure the sample does not have extreme high or low analyte levels During Auto QC measurement the Auto QC solution could not be detected e Check fluid pack level and replace if level is below 20 e Initiate AutoQC measurement manually QC manager e Perform fluidics trouble shooting procedure See Section 7 3 1 The bar code was invalid the OPTI R either misread the bar code label or it is an invalid bar code for the OPTI R e Press OK to retry e Ifthe error message appears again check the product package for intended use e Check the bar code scanner see Section 7 2 10 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 The bar code was invalid the OPTI R either misread the bar code or the product 1 e gas bottle cassette or Fluid Pack has expired e Press to retry e Ifthe error message appears again check the date in lt System gt Time and Date gt e Verify the product expiration date The cassette expiration date has been reached e Press OK to retry e Ifthe
19. Each disposable low pressure cylinder contains approximately 2 liters of gas at less than 145 psi at 21 C Oxygen 14 0 0 02 Carbon Dioxide 6 0 0 02 Nitrogen balance Refer to package labeling For automatic Quality Control cassette calibration wash and waste containment for the OPTI R Buffered solutions Aqueous HEPES bicarbonate buffer solution with biocides Refer to package labeling Operator s Manual OPTI R Analyzer 8 13 8 OPERATING PRINCIPLES Precautions Use of calibration solutions calibration gas or optodes not manufactured by OPTI Medical Systems could void the warranty Once used the sample cassette and fluid pack hold 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 2252 2302 3 Mahoney JJ Wong RJ Van Kessel AL Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 79 1993 4 J B Henry Clinical Diagnosis and Management by Laboratory Methods 19th Ed 1996 p 590 777 Clinical and Laboratory Standards Institute CLSI Interference Testing in Clinical Chemistry Approved Guide
20. Fig 3 9 allows you to program the default values for patient input parameters with the exception of patient temperature The instrument comes with factory programmed default values which represent typical values The programmed default values will be printed and used for the calculated parameters unless they are changed by the operator during a measurement You can change the default values only if the parameter has been enabled After each measurement the value will be reset to the default value even after the system has been turned off Exceptions are the Hb type and P50 which remain at the selected value until the system 1s powered off The first parameter is tHb Fig 3 9 This is the tHb value used in calculations of various parameters if measured tHb is not available e Press Enable to display the default value for this parameter 15 0 g dL Press Edit to change this value using the numeric keypad NOTE Units for the tHb and P50 may be changed per instructions found in Section 3 3 2 3 The remaining default parameters are MCHC 33 3 9o EO 0 21 RQ 0 84 Ban 26 7 mmHg NOTE The default values indicated above are the original factory settings If out of range values are entered the system automatically flags the error and shows the valid range S e Press a Sae to accept the changes e Press Q eu to return to the Setup screen or f Home to return to lt Ready gt Operator s Manu
21. Install Slope Auto QC Data Calibration Print Miscellaneous Re ports ui Gei Configuration Zo Home Fig 5 17 Select Patient Report Qu 55535 999999999999989 27May12 GA 43847 AOB1C2D3E4F 5G6H 25May12 Fig 5 18 Measurement Results Operator s Manual OPTI R Analyzer o SAMPLE HANDLING AND PATIENT TESTING This menu lets you print out patient reports You can print out individual patient results groups of patient results or all the results in memory l From the lt Ready gt display select lt Data Manager gt Press lt Patient gt Fig 5 17 In the lt Patient Measurement gt screen Fig 5 18 press the button to display the measurement results The sorting order within the individual columns may be changed from ascending to descending by pressing the column header To print individual results highlight the desired measurement To print groups of results highlight the first measurement to be printed press Q wer then select the last measurement to be printed All the measurements in between will be selected Press 9 to select all results Ga Print Press to print your selection After printing patient data may be deleted by pressing 2XPelete e After data has been deleted the system will return to the lt Data Manager gt Press f Home to return to the Ready screen e fa password has been selected under the set
22. Je MENTE OT OO Tm 3 7 3 3 2 1 Setting Normal Ranges or Alarm Limits rarnrnnnrnnnnnrrrnnnrrrrnnrenrnnnennnnnernrannennnnrennnsrsnnnnnne 3 7 3 3 2 2 Setting up Correlation ee EEN 3 9 STV 3 10 TN NNN 3 11 3 3 2 5 Setting the ad ULC eg Ee 3 14 3 3 2 6 Entering the Barometric Pressure REENEN 3 15 LT Beep ENN beaten 3 16 3 3 2 6 AO BNR akkar 3 16 3 3 2 9 EE 3 17 3 3 2 10 Selecting EE ue De uid uini pepe taie nale aem E ER icd Madam nM dad ME 3 18 Operator s Manual OPTI R Analyzer 3 i 3 CUSTOMIZATION 3 CUSTOMIZATION Your OPTI R analyzer is shipped preset to easily perform sampling operations Through the touch screen you can enter patient data and initiate printing of patient QC and calibration reports as well as enter additional information to tailor the instrument s performance to match the particular needs of your lab For safety and security the OPTI R customization can be protected by a security code The analyzer s programming or existing parameters can then be changed only by entering the correct security code All system setup selections entered will reside in the instrument memory even after the system power is turned off 3 1 Data Manager This menu allows you to print out Measurement Diagnostics Reports and Statistics It also provides you with the ability to export information if connected to a computer You can find procedures for printing information in Chapter 4 Calibration and Quality Control
23. Level 2 1 196 0 015 1 3 0 009 0 8 0 017 1 4 Level 3 0 808 0 021 2 6 0 006 0 7 0 025 3 1 Serum 0 43 0 022 5 1 0 008 1 9 0 029 6 7 Reduced Bovine Hemoglobin 1 11 0 010 0 9 0 020 1 8 0 022 2 0 Solution Ca 2 Operator s Manual OPTI R Analyzer ANALYTES CALCIUM All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI R measurement has been established against reference materials or methods Ionized calcium linearity is established by measurement of gravimetrically prepared N LS T traceable aqueous standard solutions ionized calcium and by measurement of N LS T Standard Reference Material 956a Electrolytes in Human Serum ionized calcium sy Correlation Slope Intercept Coefficient Sy x Range n ionized Calcium 1 0213 0 039 0 99940 0 027 0 47 2 6 30 ionized Calcium 1 0373 0 057 0 98509 0 058 1 07 1 71 14 NIST Correlation to Other Methods OPTI R 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 ope
24. SO 89 8 PO and PCO above 100 mmHg are always displayed to the nearest whole number Your OPTI R has been factory preset to the following units Baro Partial Pressure mmHg Temperature SE tHb g dL Electrolytes mmol L Resolution Low S Press ad Save to accept the changes Press G3 UP to return to the lt Setup gt screen to return to lt Ready gt Operator s Manual OPTI R Analyzer 3 3 2 4 Setting up Security Not Ready 10 40 12 Nov Customize Patient Information Measured Calculated Patient el Parameters Parameters Miscellaneous Correlation Units Printer Hardware Language Q ve f Home Fig 3 23 Select Security Normal Ranges Alarm Limits 3 3 2 4 1 Setting Up a Password System gt Setup gt Security Password QC Lockout OPIDs Password Enable lw Setup PW 9 Edit cancel pl Save Q Up Thome Fig 3 24 Enter Password Operator s Manual OPTI R Analyzer 3 CUSTOMIZATION The OPTI R has three types of security 1 A Password Function to limit access to various system functions See section 3 3 2 4 1 2 QC Lockouts to help hospitals meet their QC policies See section 3 3 2 4 2 3 ASecure Operator ID function to limit access to analyzer to properly trained authorized users See section 3 3 2 4 3 e From the Ready display select System Manager and Setup e Inthe System Setup menu press
25. both of the above options NOTE If NO is selected here the new information is not saved Press the Ranges 1 gt tab to confirm the assay ranges on the package insert supplied with the control material Fig 4 12 If the bar code is unavailable press the Edit button and enter the numbers using the keypad Press f Seve to accept Press lt Ranges 2 gt to go to the next display to enter the ranges for all other measured parameters available with this control material Fig 4 13 Enter 0 0 for unassayed parameters Alternately you may develop your own assay ranges from multiple measurements according to your hospital s procedures It is recommended you review all analyte assay ranges You may press fal Save at any time after the bar code is scanned and the ranges will be accepted from the bar code To continue quality control programming repeat the above procedure for QC Level 2 and QC Level 3 Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 5 2 Performing QC Measurements 4 5 2 1 Running Auto QC Measurements Ready 10 40 12 Nov Run Control Setup Auto QC Control Q ve rem Fig 4 14 Select Auto QC Enter Operator ID Jesse pop mi e eg URS RESET HS ef rele jeg ep paler ef ry fe z c M Space B Fig 4 15 Enter Operator ID Select Level 1 2 Cancel OK Fig 4 16 Select Auto QC Level O
26. pps 2252 2302 5 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and Actuators 9 p 85 1986 6 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI R Analyzer pH 3 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 Measurement Range Range Resolution Low High Units 10 to 200 1 0 1 mmHg Reference Intervals Each laboratory should est
27. removed Not Ready 10 40 12 Nov Installation Utilities Component Installation e Go to the System Manager Utilities 2E Genen Installation gt tab and press lt Repeat Pack Install gt Gas Bottle vp from Not Ready 10 40 12 Nov Select Level s to Rerun e Select the failing AQC level s and repeat measurement Level 1 r Level 2 e Ifthe problem persists replace cassette and or Level 3 r fluid pack mi Operator s Manual OPTI R Analyzer 7 15 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 Diagnostics Not Ready 10 40 12 Nov Time and Date Diagnostics Setup Utilities Up NE Za Home Fig 7 1 Diagnostics 7 2 1 Checking Versions System Diagnostics Not Ready 10 40 12 Mov OPTI Mainboard 1 00 0000 1 00 0000 Optica Module OPTICZH 1 00 0000 1 00 0000 Te Temperatt Top Plate 31 7 C Ambient 4317 C Bottom Plate 31 7 Preheater 417 C Wash Bufer 31 7 C LEDs Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 lon 1246 SMC Cover Closed Waste 752 Miscellaneous Barometric Pressure 723 44 mbavkPa Back E3 Next Ge sm T Fig 7 2 Versions 7 16 Your OPTI R has a number of useful diagnostic programs From the lt Ready gt display press lt System Manager gt Diagnostics gt Fig 7 1 The lt Diagnostics gt screen contains five menus with various diagnostic functions lt
28. screen or f Home to return to lt Ready gt Operator s Manual OPTI R Analyzer 3 3 2 Miscellaneous 3 CUSTOMIZATION 3 3 2 1 Setting Normal Ranges or Alarm Limits Not Ready 10 40 12 Nov Customize Patient Information Measured Calculated Patient el Parameters Parameters Miscellaneous Normal Ranges Correlation Units Alam Limits co Security Printer Hardware Language Q ve f Home Fig 3 14 Select Normal Ranges Alarm Limits System gt Setup gt Normal Ranges Alarm Limits gemmam i 10 40 Limits 1 Limits2 Limits3 Select Range Name Reference te Normal C Physiologic C Alarm C Critical C Q Up L Home Fig 3 15 Select Limits Name Operator s Manual OPTI R Analyzer This menu enables you to change both the limits name as it appears on the printout and the limit values themselves for pH PCO and all other measured parameters These limit names can be based on your hospital policy and may be selected from the following Reference Normal Physiologic Alarm or Critical A result that is outside the limits you define here will be flagged with an up arrow if high or down arrow if low A message is included on the printout explaining each arrow using the name selected here NOTE When the patient temperature has been changed both the uncorrected and corrected parameters will be checked against the limit values programmed here and
29. to enter the start and end date Press 0K to generate statistics report Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 5 1 2 Setting up the External Control Material Lot and Level Ready 10 40 12 Nov Run Auto QC Control Setup O Q ve Ta Home Fig 4 9 Select Control IIIA Scan Barcode Manual Cancel Fig 4 10 Scan Bar Code LA From the lt Ready gt display select lt QC Manager gt Select Control under SETUP Fig 4 9 Scan the 36 digit bar code marked Scan A for the applicable level supplied with OPTI CHECK Fig 4 10 Scan the second 36 digit bar code marked Scan B supplied with the same OPTI CHECK control lot These two bar codes contain all necessary lot information for each level and may be confirmed in the subsequent screens If bar code is not available press Manual on the Scan Barcode screen and manually enter control data 4 5 1 2 1 Entering Control Expiration Date Type and Assay Ranges Qc gt Setup Control Not Ready 10 40 12 Nov Level Ranges 1 Ranges 2 1 2 3 Level Fr E C Lot Number i Edit Expiration AL Edit Type OPTLCHECK Other C C cancel f Sawe Q Up L Home Fig 4 11 Confirm Lot Information Operator s Manual OPTI R Analyzer When you open a new box of OPTI CHECK the lot number should be entered into the analyzer along with the target rang
30. 0 to 800 0 1 mmHg AaDO Es 15 to 35 0 1 mmHg nCa 0 1 to 3 0 0 1 mmol L 8 5 5 Calibration Each lot of OPTI R 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 the first 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 1s then installed and a calibration is performed using the precision buffer within the cassette the buffer contained in the Fluid Pack and a precision gas mixture similar to that used by conventional blood analyzers In addition an optical zero point calibration of all six channels is performed During the calibration and measurement processes diagnostic tests are automatically performed to assure correct operation of the instrument and measurement of the cassette These tests include automatic checks of the cassette 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 du
31. 2 3 Defining Units Not Ready 10 40 Customize Patient Information Miscellaneous Language ve f Home Fig 3 21 Select Units System gt Setup gt Units Barometer Partial mmHg Pressures Temperature c C tHb g dL g L D e Ca mill C Resolution Low Qo Defaults B Qv Qu Home Fig 3 22 Select Units 3 10 12 Nov Measured Calculated Patient el Parameters Parameters Nomal Ranges Correlation Com Alarm Limits Security Printer o EH 12 Nov mbarkPa E This menu lets you change the units of measure for pressure temperature total hemoglobin Ca and output resolution l ES From the lt Ready gt display select lt System Manager gt and lt Setup gt In the lt System Setup gt menu press lt Units gt Fig 3 21 In the lt Units gt screen select the units for the displayed parameters Fig 3 22 The selection for lt Resolution gt on this menu determines the number of digits displayed and printed past the decimal point for all measured parameters NOTE The selection applies to sample results only Resolution is always High for Control results Resolution examples are shown in the following table Low High pH 7 34 pH 7 341 PCO 43mmHg PCO 43 2 mmHg PO 87 mmHg Na 143 mmol L K 4 6 mmol L PO 86 8 mmHg Na 143 3 mmol L K 4 57 mmol L Ca 1 21 mmol L Ca 1 21 mmol L tHb 14 6 g dL tHb 14 6 g dL SO 90
32. 47 press Yes to initiate the powerdown or No to return to the lt Utilities gt menu e The system will then power down Fig 6 48 e Turn the instrument off when prompted Fig 6 49 Operator s Manual OPTI R Analyzer 6 6 3 2 Shutdown Procedure System gt Utilities Not Ready 10 40 12 Nov Installation Utilities Master Calibration Calibrator Run Run Power Control X7 Q ve Home Fig 6 50 Select Shutdown Shutdown Are You Sure You Want toShutdown Yes Mo Fig 6 51 Confirm Shutdown syste m gt Utilities gt Shutdown Not Ready 1040 12 Nov Remove Fluid Pack Fig 6 52 Remove Fluid Pack Operator s Manual OPTI R Analyzer 6 MAINTENANCE This routine assists you in performing a complete shutdown of the analyzer A complete shutdown may be initiated to prepare the analyzer for shipping or in case the analyzer is not being used for an extended period of time exceeding 72 hours e Never attempt to turn off the power for an extended period of time gt 72 hours without performing a complete shutdown of the analyzer e Ifthe analyzer is not being used for less than 72 hours it is recommended to perform a power down instead of a shutdown See Section 6 6 3 1 To perform the shutdown you will need the following items e Two containers one filled with at least 50 mL of water the other one empty e One shutdown pack supplied with the accesso
33. 6 2 6 3 6 MAINTENANCE MAINTENANCE Daily Maintenance No daily maintenance is required for the OPTI R analyzer Weekly Maintenance Once a week the Sample Measurement Chamber SMC must be cleaned It is recommended that cleaning should be performed when changing the cassette since it will result in premature expiration of the sensor cassette Open the top cover and clean the optics surface as well as the underside of the SMC cover with a lint free cloth dampened with a dilute alcohol or ammonia based cleaner as needed Be sure to remove all blood residue A cotton swab may be used for cleaning the smaller parts of the SMC Quarterly Maintenance Running the Calibrator Not Ready 10 40 12 Nov Calibration of the tHb channel and the measurement SE er LEDs is required every 3 months i iagnostics i i This calibration is performed using the Calibration Cassette in a manner similar to other instruments that measure tHb and or hemoglobin derivatives Setup S e optically The calibration verifies the measurement optics and electronics and corrects any potential drift The calibrator measurement should be performed Qu Py Home when changing the cassette since it will result in premature expiration of the sensor cassette Fig 6 1 Select Utilities Baia l In the Ready display select System ot Ready 10 40 12 Nov Manager Utilities Installation 2 Inthe System
34. Check Time and Date O A ERROR Waste not Detected O A ERROR Bad Calibrator Date g 7 6 During Fluid Pack installation the wash buffer was found to be contaminated due to a damaged pouch e Press OK and replace the fluid pack During Fluid Pack installation the AQC L1 was outside the limits e Press hb and rerun AQC L1 once prompted This message indicates that the Fluid Pack inserted has a fill level of less than 90 e Press OK to replace the Fluid Pack NOTE A used pack can only be reinstalled in the same instrument from which it was removed This error appears when a newly installed pack is defective and fails calibration verification e Press OK discard the defective pack and install a new fluid pack The current time date is invalid as compared to the fluid pack manufacturing date e Please check the date of the instrument in the Time Date setting menu In particular make sure the year is entered correctly The waste sensor is unable to detect fluid movement e Cycle power and check if error recurs e Replace cassette The expiration date of the calibrator cassette is invalid e Check Time Date of instrument e Re enter lot number of calibrator cassette e Replace calibrator cassette Operator s Manual OPTI R Analyzer ERROR Invalid Sample K ERROR QC L1 not detected Replace Fluid Pack OK E ERROR Invalid Barcode OK
35. Ee E 3 7 3 3 2 1 Setting Normal Ranges or Alarm Limits rrrrnrnnnrnnnnnnrvnnnrrnrnnnenrnerernnnnernrnnrennnsnennnnrsnnnnnne 3 7 3 3 2 2 Setting up NNN 3 9 JIS Defining res 3 10 MT ENN 3 11 33 2 5 STE PTE sne 3 14 3 3 2 6 Entering the Barometric Pressure L mranskrusmennmumarnmnn sgmnlmedsnjau vdesdus ndin 3 15 3 3 2 7 Beep Adjustment E 3 16 9 26 ADN Backlight FI TT EE 3 16 3 3 2 9 Setting Up Communications aaansannennneannnnsnnesrnrnrrrnsrnrrnnrrrrrrnsrrrsrnrrsrrrrnnrresrrenenrrnnne 3 17 3 9 2 10 Sel cting a Langu gt EE EEE D RU 3 18 Operator s Manual OPTI R Analyzer TABLE OF CONTENTS 4 CALIBRATION AND QUALITY CONTROL eere 4 1 NEEDED 4 1 4 2 QC Overview r nrrnnunnnvnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnunnnnnnnnnnunnnnnnnennunnnnnne 4 2 4 9 Proficiency es Le BE 4 2 44 Calibration verda EN 4 3 45 QC e le le Ed te TEEN 4 3 251 OG SOD veriistesineiedceseinetesiniswenesunceasusiemsnesseni semen iesasane enka Rb a CJ DNI E Era 4 4 4 5 1 1 SMN Ledende 4 4 4 5 1 2 Setting up the External Control Material Lot and Level 4 7 4 5 2 Performing QC Measurements 4 9 4 5 2 1 Running Auto QC Measurements nne 4 9 4 5 2 2 Running an External QC Sample OPTI CHECK essere 4 11 li fe Trig QC REPONS enuanta re eee en eee ee bung EU 4 15 4 5 9 1 Printing Auto QC Reports eie iota etn netten phones dnsolisinsseesatbecsineurcgestahoassiatasie ewes 4 15 4 5 3 2 P
36. NENNE D 5 Controls Statistics Report EEE REE D 6 Patient Measurement Calibration Report rrrnnrnnnenanennnennnennnernnennnennnnnnnnnnennunnnunnnunnnennneennnennne D 7 Patent Diagnostics Calibration IRC DOM EE D 8 ENN D 9 Configuration Repon Part T Lee D 10 Configuration Report Eegeregie D 11 ETR D 12 NET D 13 Operat r ID REDO RR D 14 INDEX e ER 1 VI Operator s Manual OPTI R Analyzer 1 1 1 1 2 1 3 1 4 1 5 1 INTRODUCTION INTRODUC HON c 1 1 OVNEN M 1 1 Principles of Operation nrnnnnnnannnnnnnnnnnnnnnnnnnnnnnnnennnnnnunnnennnnnnnnnnnnnnnnnnnnnnnnnennnee 1 1 ce eer P 1 2 Analyzer ComponentS axrannrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnennnnnnnnnnnnnnnnennnnnnnennnunnnne 1 3 CoS le T 1 7 Operator s Manual OPTI R Analyzer 1 i 1 1 1 2 1 INTRODUCTION INTRODUCTION Overview The OPTI R Analyzer is a blood gas and electrolyte analyzer for use in whole blood serum or plasma The OPTI R Analyzer is designed to provide rapid results for pH carbon dioxide partial pressure PCO oxygen partial pressure PO sodium Na potassium K ionized calcium Cal total hemoglobin concentration tHb and hemoglobin oxygen saturation SO The table below provides important information regarding supported sample types available report
37. ON MVol ON PIP y ON Pplat ON PS e ON PEEP ON CPAP ON Rate ON Liter Flow ON I E Ratio ON BiLevel ON User Def ON User Def2 ON User Def3 ON Puncture Site ON Bypass ON Patient Info Defaults tHb 15 0 gyde MCHC 33 35 FIO2 0 21 RO 0 84 P50 t 26 7 mmHg Reference Limits pH 1 200 7 600 PCOZ 30 0 50 0 mmHg PCS 70 0 700 0 mmHg Na 135 0 145 0 mmol L K 3 50 25 10 mmol L Ca 1 12 1 32 mmol L tHb 12 0 17 0 9g dL 502 90 0 100 0 QUCToLt 92069 Exp Jan2zolo0 Level 3 LimMin LimMax pH 7550 1650 PCOZ 18 0 26 0 mmHg PO2 132 0 156 0 mmHg Na 156 0 166 0 mmol L K 4 80 6 00 mmol L Ca 0 20 3 00 mmol L tHb 8 1 11 1 g dL 502 93 0 99 0 OCLOLr 9569 Exp Janzol Fluid Pack Info Level 1 LimMin LimMax pH 7 060 7 180 PCO 61 0 83 0 MMHG POZ 18 0 42 0 mmHg Na 122 0 132 0 mmol L K 2 50 3 30 mmol L Catt 1 71 2 01 mmol L LHD LI8 9015 9 g dL 502 85 0 92 0 5 Volume 42088 uL Pack Lot 123456 Exp Jan 31 2010 Level 2 LimMin LimMax DA 7 300 7 420 POCOZ 39 0 47 0 mmHg PO2 DO U LIZ 0 mmHg Na 136 0 150 0 mmol L K 4 60 5 40 mmol L Catt 1 15 1 35 mmol L tHb 18 5 21 5 g ab 502 150 81 0 Volume 28508 uL Pack Lot 123456 Exp J n 5S1 2010 Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS Configuration Report Part 2 Level 3 LimMin LimMax FSET Values pH K gee cine Version ABCX XX PCOZ2 16 0 26 0 mmHg IDAC1 1464 PO2 138 0 168 0 mmHg IDAC2 2
38. Pump Display Touch RS232 Ethemet Flow Test eer Back E3 Next Fig 7 11 Barcode Test ESTER Scan barcode Fig 7 12 Scan Barcode Barcode Test 012345678901 234567890123456789 Fig 13 Barcode Test Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 10 Checking the Bar Code Scanner This option allows you to check the function of the bar code scanner From the Ready display press System Manager gt Diagnostics gt In the Diagnostics Sensors screen press bos repeatedly to access the lt Tests gt screen Page 5 of 5 e Press Barcode to start the test Fig 7 11 e To test the bar code scanner scan a bar code label of e g a sensor cassette Fig 7 12 e The display will show a sequence of numbers Fig 7 13 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 OK to return to the Tests screen e Press Q JP to return to the System screen 7 21 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 11 Checking the Printer 7 22 System gt Diagnostics Not Ready 1040 12 Nov Tests Page 5 of 5 Barcode m Optics Gas Test Pump Display Touch RS232 Ethemet ii Test Report EN Next Fig 7 14 Printer Test This diagnostic function lets you check for the proper functioning of
39. R Analyzer 8 5 11 Accessories 8 OPERATING PRINCIPLES OPTI R Sensor Cassette Type E Ca 50 BP7601 Use Contents Composition Storage Stability For measurement of pH PCO PO Na K Ca tHb and SO with the OPTI R Analyzer Each reusable cassette is good for 50 patient samples or 7 days of in use operation Each assembly contains 4 individually packaged cassettes Each plastic cassette contains buffer and optical sensors Aqueous HEPES bicarbonate buffer solution 0 2 mL with biocides Refer to package labeling Expiration date and lot number are printed on each cassette container label Syringe Adapter Box 250 pcs BP7600 Use Contents Composition Storage Stability Calibrator Cassette BP7535 Use Contents Composition Storage Stability Calibration Gas BP7001 Use Contents Composition Storage OPTI R Fluid Pack BP7092 Use Contents Composition Storage For use with the OPTI R cassettes when sampling from syringes Each package contains 250 syringe adapters and a package insert Not Applicable Not Applicable Not Applicable For quarterly calibration of the OPTI R 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 For calibration of pH PCO and PO in the OPTI R Analyzer
40. Range Range Resolution Low High Units 6 6 to 7 8 0 01 0 001 pH units Operator s Manual OPTI R Analyzer pH 1 pH ANALYTES Reference Intervals Each laboratory should establish its own reference interval for pH as performed on the OPTI R as factors such as altitude can affect such measurements Sample type Range Whole blood arterial Premature newborn 48 hr 7 35 7 50 Full term birth 7 11 7 36 Full term day 7 29 7 45 Children adults 7 35 7 45 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 R utilizes an internal Na sensor to actively compensate and correct for this sensitivity That is the OPTI R 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 25 mg dL unstable Cardio indocyanine green 0 5 mg dL 0 02 Methylene blue 25 mg dL unstable Only clear unco
41. Sensors gt lt Consumable Status gt lt Control gt lt Cassette Valve Drive gt and lt Tests gt From the lt Ready gt display press lt System Manager gt Diagnostics gt The first option on the Sensors screen Versions Fig 7 2 allows you to check the software version version of the optical module as well as the GUI version Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 2 Checking System Temperatures Syste m gt Diagnostics Mot Ready 10 40 12 Nov Sensors Page 1 of 5 Versions OP TI Mainboard 1 00 0000 1 00 0000 Optics Module OP TICAH GUI UO SOT emperature Top Plate 31 7 C Ambient 317 C Bottom Plate 31 7 Preheater Front 1534 Cassette Misseat Yes Rear 1436 Cassette Detect 760 lon 1246 SMC Cower Closed Waste 752 Miscellaneous Barometric Pressure 7234 mbankFa Back Next ue ot H Fig 7 3 Temperature 7 2 3 Checking the LEDs System gt Diagnostics Not Ready 10 40 12 Nov Sensors Page 1 of 5 Versions OPTI Mainboard 1 00 0000 1 00 0000 Optics Module OF TK ZH SU 1 00 0000 1 00 0000 Temperature Top Plate 31 7 C Ambient 317 C Bottom Plate Suter dif C 4L C 1534 Cassette Misseat Rear 1436 Cassette Detect 760 lan 1246 SMC Cover Closed 752 i Up Fy Home Fig 7 4 LEDs Operator s Manual OPTI R Analyzer From the lt Read
42. X Fig 6 37 Ready screen 6 14 If you remove the gas bottle and reinstall it respond No at the prompt New Gas Bottle gt You will then be prompted to enter the number of weeks in service using the numeric keypad Fig 6 36 Here you may refer back to the installation date which was recorded on the gas bottle 9 The Ready display will now be reset to reflect the status of the new gas bottle identifying the percentage remaining Fig 6 37 Operator s Manual OPTI R Analyzer 6 5 4 Changing the Printer Paper Fig 6 39 Insert New Roll E Fig 6 40 Tear Off Excess Paper Operator s Manual OPTI R Analyzer 6 MAINTENANCE The thermal printer paper supplied by OPTI Medical contains an indicator strip to alert you when the paper roll should be changed To change the roll Open the cover on the top of the analyzer Press the paper advance button to eject any remaining paper Fig 6 38 Remove the old roll With the OPTI R powered on place a new roll of paper in the chamber and thread it into the feeder Use the diagram in the paper well to make sure the paper is inserted correctly Fig 6 39 As soon as the printer detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if the paper is present To advance paper after the initial installation press the red paper advance button located on
43. allow you to run one STAT sample after calibration and between each Auto QC sample for a total of 4 samples STAT samples can be run approximately 10 minutes into the installation The option to run a STAT sample will time out after 3 minutes after which the OPTI R will go on to the next operation in the installation Using this option will add additional time to the installation process Press ___ to skip the STAT sample option Fig 2 21 and continue with the installation By default the STAT sample option is disabled NOTE During the measurement of the STAT sample the cassette calibration has been verified but Auto QC verification of the cassette is still pending Wait for completion of Auto OC verification to verify accuracy of the STAT sample results 2 9 2 SETUP 2 10 Measurement Ready Samples Bu Start Sample Pack Measurement 3 Gas 50 Bara 7324 Next Event 05 18 Run Sample Data QC System Manager Manager Manager i Fig 2 22 Ready Display The Ready Display Once calibration and 3 levels of AutoQC measurements are completed the Ready display will appear Fig 2 22 The Ready display informs the user of important status information such as lt of Samples Number of patient samples remaining on the cassette currently installed in the analyzer Pack Percent remaining in the OPTI R Fluid Pack Gas Displays the percentage
44. 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 R are on the bottom panel of the unit Please read the Instrument Warranty Terms and Conditions and become familiar with this agreement Each new analyzer purchased has a one year warranty from the date the analyzer is placed into service Contact the OPTI Medical Service Hotline for any assistance regarding warranty or support 10 4 Operator s Manual OPTI R Analyzer ANALYTES ANALYTES Ge pH 1 PU a edanentaane PCO2 1 EE PO2 1 So g 1 UE Na 1 POSTNR eee K 1 ep dte Calcium Ca RR RE Ca 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen saturate E THB SO2 1 Operator s Manual OPTI R Analyzer A i ANALYTES pH pH Clinical Significance The pH value of the blood serum or plasma may be the single most valuable factor in the evaluation of the acid base status of a patient The pH value is an indicator of the balance between the buffer blood renal kidney and respiratory lung systems and one of the most tightly controlled parameters in the body The causes of abnormal blood pH values are generally classified as a primary bicarbonate deficit metabolic acidosis b primary bicarbonate excess metabolic alkalosis c primary hypoventilation respiratory acid
45. available Hb ctO 1 39 EN tHb 0 00314 PO vol NOTE If PO is not available ctO is calculated with PO 90 mmHg If measured O Hb and tHb are not available and calculated SO is enabled SO tO 1 39 tHb 0 00314 PO 100 vol NOTE If PO is not available ctO is calculated with PO 90 mmHg 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 R allows for the estimation of P50 from measured SO PO and pH If a measured SCH Dn is not available the P50 value may be input via keypad For Adult hemoglobin P 261 1g where le Po lg O 4 172 2 9 De SO 100 SO mmHg NCCLS Blood Gas and pH Analysis and Related Measurements Approved Guideline NCCLS document C46 A 2001 Operator s Manual OPTI R Analyzer A 11 APPENDIX A TECHNICAL SPECIFICATIONS AaDO pH cH t PCO For Fetal hemoglobin B 225 9 19h92 where js PO lg 0 4 113 2 9 SO l 100 80 mmHg The alveolar to arterial oxygen tension gradient PAO PaO
46. based on the regulatory requirements The instrument is factory set with lockout options turned off To activate these options e Select QC Lockout gt in the Security menu Fig 3 25 Control Lockout Enable With this option you can require that one two or three levels of liquid controls must be run at regular intervals If the selected number of controls is not run patient measurements will not be allowed lt 8hr gt Requires controls to be run every 8 hours lt 12hr gt Requires controls to be run every 12 hours lt 24hr gt Requires controls to be run every 24 hours lt 7dy gt Requires controls to be run every 7 days 1 Select the desired option 2 Press fq Save to accept the changes 3 Press Q UP to return to the Setup screen or f Home to return to lt Ready gt 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 Patient measurements will not be allowed unless all analytes on that cassette have satisfied the lockout requirements for number of control levels and required time period Operator s Manual OPTI R Analyzer 3 3 2 4 3 Setting up Secure Operator IDs System gt Setup gt Security 00000000000 0000 00000000000 0000 00000000000 0000 00000000000 0000 00000000000 0000 Q up Zo Home Fig 3 26 Select OP IDs Operator s Manual
47. button to display the p results Fig 7 49 Use the P and Level Date SH Dov AEE e Dom buttons to display the previous or next 12Ju4209 551 page of results 12Jul12 10 19 4 1 12302 12445 e To print individual results highlight the desired 12Jul12 13 23 L6 1 221405 measurement Fig 7 48 To print groups of ei results highlight the first measurement to be 12Jul12 15 14 9 1 1221625 printed press a then select the last measurement to be printed All the measurements Qe gm in between will be selected Press 4 to select all results Fig 7 48 Select Calibration a Print e Press amp to print your selection e Press UP to return to the Data screen Para my meter PCO2 424 0 CTT ur K 431 1 Ki mr w 59 Ge om Fig 7 49 Calibration Diagnostics 1 34 Operator s Manual OPTI R Analyzer 7 2 21 5 Event Log Ready 10 40 12 Nov Measurements Diagnostics Patient Control Install Slope Auto QC Data Calibration vr Fig 7 50 Select Event Log Data Events Ready i 10 40 12 Nov Event Log gt c Delete Za Home Fig 7 51 Print or Delete Event Log Delete the Event Log Yes M Fig 7 52 Delete Confirmation Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING This menu gives you the option to print or delete the event log from the database e To print an event log sele
48. 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 use ion selective recognition elements 10nophores 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 R using the measured pH Measurement Range Range Resolution Low High Unit
49. cover and locate the two small optical channels pictured below Fig 7 59 Fig 7 59 Locate Optical Channels 2 Clean the optical channels using a cotton swab or lint free cloth dipped in alcohol or ammonia based cleaner Fig 7 60 Fig 7 60 Clean Optical Channels Please contact OPTI Medical at 1 770 510 4444 or 800 490 OPTI 6784 or technicalsupport optimedical com for any additional questions or information regarding this procedure Operator s Manual OPTI R Analyzer 7 41 7 DIAGNOSTICS AND TROUBLESHOOTING 7 4 Troubleshooting Procedure for Bar Code Scanner If you experience difficulty scanning bar codes clean the bar code scanner window with alcohol and a lint free cloth If difficulty continues check the bar code scanner window for scratches Call OPTI Medical Technical Support for a replacement bar code scanner window 1 42 Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES 8 OPERATING PRINCIPLES rannarnuvnnnnvnnnnnnunnnnnnnunnnnnnnunnnnnnnnnnnnnnnnnnnnunne 8 1 8 1 MENGEI USE 8 1 8 2 Principles e Te UE 8 1 0 9 PAN Ned 8 2 8 4 Specimen Collection and Handling se 8 3 ON NN 8 3 8 4 2 Sample Requirements eee ORG 8 3 8 4 3 Anticoagulants and Sample Collection Devices rrrarrrnnrrnnrrnranennnrnnnnrnnrnrnnennanennnennnnnn 8 3 E SU S EE EE 8 3 949 Capillary TN 8 3 8 4 6 OPTI Medical CGomiortGamplers 8 4 8 4 7 Handling an
50. display the results Fig 7 40 Use the rue and Dow buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 4 39 To print groups of results highlight the first measurement to be printed press ark then select the last measurement to be printed All the measurements in between will be selected Press Ga to select all results Press Ga to print your selection Press D UP to return to the Data screen 7 31 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 21 2 Auto QC Diagnostic Report 7 32 Ready 10 40 12 Nov Measurements Diagnostics Patient Control Install Slope Cree ma E Calibration Event Log Up Home Fig 7 41 Select Auto QC Data gt Auto OC Diagnostics Ready 12 Nov Level Date 1 amoa me 8 1 vanene ec el ae 8 1 mes ve Home Fig 7 42 Select Measurement m F d E LR Data gt Auto QC Diagnostics gt View Para my meter pH 375 9 PCO2 4240 PO 476 3 Na 102 8 K 431 1 ve fa Home Fig 7 43 Auto QC Diagnostics The lt Auto QC Diagnostic Report gt shows details of measured signals in millivolts as well as drifts observed during the measurement To print an Auto QC report select lt Diagnostics gt Auto QC gt in the lt Data gt screen Fig 7 41 In the lt Data Auto QC Diag
51. een E T dekade 4 15 4531 Printing Auto OG Reports uden AER RTENE AA 4 15 4 5 3 2 Printing External Control Hepnorts A 4 16 4 5 4 Sending Data to a Computer rrnrnrrnnornnnrnanrnnnnnnanrnnanennnnrnnnrnnannnanennanrnnssnnnnennnnnnansnnnne 4 17 26 CAND E TETTE UST 4 18 Operator s Manual OPTI R Analyzer 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 two bar codes containing this calibration information as well as its lot number and expiration date For each new cassette the cassette s bar code is read into the analyzer by holding the cassette package in front of a conveniently located bar code scanner The cassette is then installed and a calibration verification is performed using a precision gas mixture and wash buffer from the fluid pack in a manner similar to other combined blood gas ion analyzers In addition an optical zero point calibration of all optical channels is performed After the cassette has passed the initial calibration the OPTI R utilizes a unique calibration matrix The calibration verification 1s performed every 30 m
52. eisu sen 041005 041005 jusuodwoy OP ony 90 oiny Aua ju yed inso juaned Son dnjes sonsoubelg ejeq pue eui 90 dree 20 ung i t f i f t f JUSWSJNSBAN Jabeuep uas s Jebeuep 90 JeBeue v geq t f f nua peay B 1 Operator s Manual OPTI R Analyzer 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 Initial Date Initial Date Initial Initial SEMIANNUALLY Date Initial Date Initial Date Initial Date Initial Replace peristaltic pump cartridge AS NEEDED Initial Date Initial Date Initial Date Initial Clean analyzer surfaces JP Y Change gas bottle LLJ LL TI II Change cassette f PP Change fluid pack LLJ II TI II Change printer paper Operator s Manual OPTI R Analyzer C 1 APPENDIX D REPORT FORMATS APPENDIX D REPORT FORMATS Basic Patient Report OPTI Medical OPTI R P50 Patient Report VntMode DD MMM YY HH MM PV OL 0 MVol O Pat ID 123456789012345 PEP O Access No 123456789012 Poplar 0 0 Sample No 2345 Po 68 PEEP 0 ACID BASE 37 C CPAP 0 O 9 O pH TJA Rate f PCO 41 0 mmHg L Flow PO2 84 mmHg TE is td BE 3s mmol L BiLevel 0 0 LCOZ DEP mmol L PuncSite LR HCOS 21 mmol L Bypass
53. flagged accordingly 1 From the Ready display select lt System Manager gt and lt Setup gt 2 Inthe System Setup menu in the Miscellaneous section press Normal Ranges Alarm Limits gt Fig 3 14 3 Onthe Limits 1 gt tab select the limits range name you wish to use Fig 3 15 Reference Normal Physiologic Alarm Critical 3 7 3 CUSTOMIZATION System gt Setup gt Normal Ranges Aarm Limits p Qm l pH 72 gea 76 Gel PCO2 30 0 edt 50 0 eat PO2 70 0 eat 700 0 seat Ca 112 Meat 132 Seat cancel Default H Save Q Up Home Fig 3 16 Enter Limits 2 System gt Setup gt Normal Ranges Aarm Limits Not Ready 10 49 TEN Limits 2 C ume O Limits 1 Low High tHb 120 geat 17 0 gest S02 90 0 Edit 100 0 Edit Eca el Defaults H Save Q Up Le Home Fig 3 17 Enter Limits 3 4 Press lt Limits 2 gt to advance to the next screen Fig 3 16 5 Select the parameter you want to change and press Edit to enter the new limit value 6 Press Save to accept the new limit value 7 Press Limits 3 to advance to the next screen Fig 3 17 with the remaining parameters The instrument is preset to the following ranges of limit values pH 7 2 7 6 PCO 30 50 mmHg PO 70 700 mmHg Na 135 145 mmol L K 3 5 5 1 mmol L Ca 1 12 1 32 mmol L tHb 12 17 g dL SO 90 100 2 e Units ma
54. is aware of the dangers involved Instrument repairs are to be performed only by the manufacturer or qualified service personnel Important Information Important Information Operating Safety Information e Overvoltage Category II when connected to a branch circuit e This equipment has been tested and found to comply with the limits for a Class A digital device pursuant to Part 15 of the FCC Rules Caution e The instrument is designed as a conventional device closed not waterproof type e Do not operate the instrument in an explosive environment or in the vicinity of explosive anesthetic mixtures containing oxygen or nitrous oxide e This instrument is suitable for continuous operation e 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 e 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 e 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 maximum energy output is as follows 670 nm LED 40 Microwatts max for 400ms 780 nm Laser 40 Microwatts m
55. is not yet set up you should begin by reading Chapters 1 and 2 For programming and quality control functions read Chapters 3 and 4 Information on analyzer operation and maintenance is contained in Chapters 5 and 6 Detailed service information and operating principles can be found in Chapters 7 and 8 TABLE OF CONTENTS Table of Contents VDO DENNIS oars ERE ELE VII EEN IX eo Vun NE E E ES IX FOW to use his AA EE EEE NE IX 1 INTRODUCTION WE 1 1 LT e UE 1 1 1 2 Principles or Operation Luse 1 1 t3 E e sos E E E E 1 2 1 4 Analyzer ComponentS anxrannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnennnnnnnnnnnnnnnnennnnnnnennnnnnnunnnne 1 3 71 5 ee TE 1 7 AE LU ude 2 1 2 1 Important Safety InstructiOnS raxrnnnennnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnunnn 2 1 22 GhooSsild 3 LOCO uiri cse dei cte suus Dou NEE US NE eU US Ru EEEE 2 1 2 3 Setting up the OPTI R Analyzer annnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnunnn 2 2 3 GUS TFOMZANON m 3 1 fu WE e EC CHEN CL LTE 3 1 22 Setting Time and Date 2 3 1 Gr SCUD WEEN 3 2 3 3 1 Customizing Patient Information 3 3 3 3 1 1 Selecting Which Patient Information is Requested and Printed 3 3 3 3 1 2 Selecting Which Parameters Are DBlankedisabled 3 5 3 3 1 3 Selecting Which Calculated Parameters Are Printed c cccseseeceeeeecesseeeseeeeeseaaees 3 6 Se Eer
56. 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 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 5 1 6 OPTI Medical ComfortSamplers Blood may be collected for analysis on the OPTI R 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 5 1 7 Handling and Storage of S
57. minimum sample volume of 125 uL is used e Remove any bubbles in the sample Sample was detected at the front light gate but did not reach the rear light gate e Confirm the message by pressing HU and let the instrument clear the error through automatic cassette wash e Replace the cassette e ferror persists call OPTI Medical Technical Support This display only appears once prior to the expiration of the 3 month calibration and acts as a reminder to run the Calibrator e Press OK Ito continue e Goto lt System Manager gt Utilities gt and run calibrator The number of secure users operator IDs stored in memory equals 300 e Press OK D continue e Delete unused Operator IDs from memory See Section 3 3 2 4 3 During Auto QC measurement the Auto QC solution could not be detected e Check fluid pack level and replace if level is below 20 e Perform fluidics trouble shooting procedure See Section 7 3 1 Operator s Manual OPTI R Analyzer WARNING Buffer not detected Check Fluidics x WARNING Gas not detected Check Fluidics CH WARNING Fluid Pack Low Replace Fluid Pack OK WARNING Gas Low Replace Gas Bottle OK WARNING 2 Samples Left Replace Cassette CEN WARNING No Patient ID Entry x Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The instrument could not successfully aspirate wash buff
58. 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 8 5 Procedure 8 5 1 Materials Needed Description Part Number sensor Cassette Type E Ca 50 BP7601 Syringe Adapters 250 per box BP7600 OPTI R Fluid Pack BP7092 Calibration Gas Bottle BP7001 Printer Paper HP0070 Calibration Cassette BP7535 The OPTI R automatically processes the sample through the necessary steps then displays and prints the results For details of this operation please refer to the remainder of the Operator s Manual Operator s Manual OPTI R Analyzer 8 5 8 OPERATING PRINCIPLES 8 5 2 Test Conditions Sample Size Sample Type Sample Application Ambient Temperature Relative Humidity Type of Measurement 8 5 3 Input Values Parameter Range Patient ID 15 alphanumeric characters Operator ID 11 alphanumeric characters Accession Number Patient temperature T Patient Sex Hemoglobin type DOB Puncture Site Bypass 8 6 12 alphanumeric characters 14 to 44 58 to 111 Male female or adult or fetal MMM DD YYYY LR RR LB RB LF RF Cord Scalp where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right Femoral Cord Cord Scalp Scalp Off Pump On Pump a minimum of 125 uL heparinized whole blood serum and plasma sy
59. pH or electrolyte concentration Na K Ca of the blood in direct contact with the sensors as described above The light emitted by the fluorescent sensors is 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 1s converted by the microprocessor to a numeric readout in conventional units of measure and displayed on the front of the device Other values commonly used for the assessment of oxygen and acid base status are calculated from these measured values 8 2 Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES 8 4 Specimen Collection and Handling 8 4 1 Safety Universal precautions must be observed when collecting blood specimens It is recommended that all blood specimens be handled a
60. 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 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 R using the measure
61. prevent such errors 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 R 8 4 Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES The OPTI R 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
62. 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 Operator s Manual OPTI R Analyzer 5 3 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 8 Test Conditions Sample Size a minimum of 125 uL sample Type heparinized whole blood serum and 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 and reflectance tHb SO 5 2 Sample Preparation 5 2 1 Whole Blood Samples Collect blood in a heparinized syringe a capillary tube or a ComfortSampler Whole blood samples should be analyzed as soon as possible ideally within 5 minutes after collecting the sample For brief storage of up to one hour the sample should be iced WARNING Whole blood samples require the proper amount of anticoagulant to prevent the sample from c
63. 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 Erythrocyte aggregation and sedimentation 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 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 R The OPTI R 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
64. the Extracorporeal Circuit Life Supports Systems 4 p 94 1986 4 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 5 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI R Analyzer PO2 3 ANALYTES SODIUM Sodium Na Clinical Significance Sodium is the major cation of extracellular fluid Its primary functions in the body are to chemically maintain osmotic pressure and acid base balance and to transmit nerve impulses Sodium functions at the cell membrane level by creating an electrical potential between different cell membranes causing the transmission of nerve impulses and neuromuscular excitability to be maintained Sodium is involved in some enzyme catalyzed reactions as a cofactor The body has a strong tendency to maintain a total base content and only slight changes are found even under pathologic conditions Low sodium values hyponatremia usually reflect a relative excess of body water rather than a low total body sodium Reduced sodium levels may be associated with low sodium intake sodium losses due to vomiting or diarrhea with adequate water and inadequate salt replacement diuretics abuse or salt losing nephropathy osmotic diuresis metabolic acidosis adrenocortical insufficiency congenital adrenal hyperplasia dilution t
65. the Fluid Pack is inserted the system will detect the presence of the Fluid Pack and retrieve the pack information The system will now perform an integrity check of the Fluid Pack Fig 6 29 6 11 6 MAINTENANCE 6 5 3 Changing the Gas Bottle NotReady A 1040 12 Nov Samples cas Not Ready 5 Low Gas Bare 732 4 Data Manager Au Fig 6 30 Changing Gas Bottle System gt Utilitles Not Ready 10 40 12 Nov Installation Utilities Component Installation Fluid Pack Cassette Repeat Pack Gas Bottle install Q3 up f Home Fig 6 31 Installing new gas bottle System gt Utilities gt New Gas Installation 10 40 12 Nov Remove Gas ee o Cancel Fig 6 32 Remove Gas Bottle 6 12 The gas bottle is designed for 80 120 measurements When this display appears Fig 6 30 the gas bottle is empty and needs replacement 1 In case of an empty gas bottle press New Gas Bottle 2 Otherwise go to System Manager gt Utilities gt and press Gas Bottle on the Installation tab Fig 6 31 3 Unscrew the old gas bottle by turning the knob on the bottom counterclockwise Fig 6 32 Operator s Manual OPTI R Analyzer System gt Utilitiles gt New Gas Installation Manual Cancel Fig 6 33 Scan Bar Code System gt Utilities gt New Gas Installation l 10 40 Please Insert Gas Bottle E
66. the built in thermal printer To activate From the lt Ready gt display press lt System Manager gt Diagnostics gt In the lt Diagnostics Sensors gt screen press Next repeatedly to access the Tests screen Page 5 of 5 Press lt Printer gt to start the test Fig 7 14 The printer will output a test print Check if the alphanumeric printout is legible and all the characters are properly printed If the printout is deficient your printer may need replacement To replace the printer follow the steps below Turn the OPTI R off Remove the paper roll and pump cartridge Unscrew the two thumbscrews holding the printer in place Pull printer up and out towards the paper tray Disconnect the cable from the receptacle Install the new printer in reverse order Operator s Manual OPTI R Analyzer 7 2 12 Checking the Optics 7 DIAGNOSTICS AND TROUBLESHOOTING System gt Diagnostics This option checks the optics and electronics for Not Ready m 10 40 12 Nov Tests Page 5of 5 drift and instability This test is designed for trained service personnel Running this test will invalidate Spee the cassette Gas Test Puno Display From the lt Ready gt display press lt System Manager gt lt Diagnostics gt we Bis See In the Diagnostics Sensors screen press TS Print Enor FN repeatedly to access the Tests screen Re e Page 5 of 5 3Back Que ii lerem
67. 0 001 pH units PCO 10 200 1 0 1 mmHg PO 10 700 1 0 1 mmHg Ad Operator s Manual OPTI R Analyzer APPENDIX A TECHNICAL SPECIFICATIONS Reference Ranges Parameter Units Range Reference Source Actual bicarbonate HCO3 mmol L 18 to 23 Tietz page 2179 Base excess BE Tietz page 2179 Base excess ecf BE Tietz page 2179 Base excess actual BE 2 to 203 Tietz page 2179 Standard bicarbonate st HCO 22 to 24 Oxygen saturation SO c Henry page 1453 Oxygen content O ct Tietz page 2200 Hematocrit Hat Hydrogen ion concentration cH 36 to 44 Tietz page 2201 Alveolar arterial oxygen partial mmHg 5 to 20 Henry page 157 pressure difference AaDO 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 R Analyzer A 5 APPENDIX A TECHNICAL SPECIFICATIONS Data Management Printout Built in thermoprinter Communication I x RS232C I x CF slot I x Ethernet port Format ASCII and ASTM Storage Data storage on the OPTI R is dyn
68. 0 3 10 8 Technical ASSiIStance x anxnnnnnnunnnnnnnnnnnnnnennnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnennunnnunnn 10 3 10 9 Warranty Registration U S Market Only 10 4 Operator s Manual OPTI R Analyzer 10 i 10 SUPPLIES 10 SUPPLIES Each OPTI R 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 Entry representatives will gladly provide any assistance you may require 10 1 Analyzer OPTI R Analyzer GD7031 with Accessory Kit 10 2 Cassettes OPTI R Cassette E Ca 50 4 pcs BP7601 10 3 Controls Calibrators OPTI CHECK Trilevel HC7008 Calibrator Cassette BP7535 Operator s Manual OPTI R Analyzer 10 1 10 SUPPLIES 10 4 Consumable Items Printer Paper 1 roll HP0070 Calibration Gas Bottle 1 pc BP7001 Fluid Pack 1 pc BP7092 Capillary Tubes 250 pcs MC0024 Syringe Adapters 250 pcs box BP7600 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 CF Export Kit BP7140 1
69. 0 6 Manuals Operator s Manual PD7032 Service Manual PD7039 10 2 Operator s Manual OPTI R Analyzer 10 SUPPLIES 10 7 Spare Parts Peripump Cartridge Kit BP7118 Power Supply EI7007 Power Cord EX0197 Power Cord Schuko EX0173 Printer Assembly BP7090 Cassette Shutdown BP7111 Pack Shutdown BP7110 Bottle Shutdown MK0056 10 8 Technical Assistance Most often problems with your OPTI R 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 R Analyzer 10 3 10 SUPPLIES 10 9 Warranty Registration U S Market Only After successful completion of the installation of your new OPTI R complete the enclosed Installation
70. 0 8 Cardio indocyanine green 0 5 mg dL 0 4 Methylene blue 25 mg dL unstable Only clear uncolored quality control materials such as OPTI CHECK brand aqueous controls should be used with the OPTI R system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated K 2 Operator s Manual OPTI R Analyzer ANALYTES POTASSIUM Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI R instruments Potassium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level 1 2 93 0 029 1 0 0 019 0 6 0 043 1 5 Level 2 4 89 0 012 0 2 0 029 0 6 0 034 0 7 Level 3 5 94 0 018 0 3 0 038 0 6 0 045 0 8 Serum 7 39 0 047 0 6 0 076 1 0 0 150 2 0 Reduced Bovine Hemoglobin 5 34 0 025 0 5 0 063 1 2 0 072 1 3 Solution All specific performance characteristics tests were run with default instrument calibration and after nor mal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI R measurement has been established agai
71. 024 Na 150 0 164 0 mmol L TDAC3 708 K 5 30 6 30 mmol L S N XXXX Ca 0 60 0 84 mmol L MAC 00 50 02 3D BT 224 tHb 8 0 11 0 g dL pH False 583 502 92 0 98 0 02 False 2116 Volume 29150 uL CO2 False 663 Pack Lot 123456 Ca False 1855 Exp J n 31 2010 K False 9151 Buffer LimMin LimMax Na False 2335 T4280 74410 Low Limit 278 40 0 48 0 mmHg Up Limit 1985 159 0 185 0 umblcd Low offset 500 000 1370215150 mimo 1 1 Up factor 0 800 4 90 5 70 mmol L Home offset 240 1 20 1 40 mmol L PHR Correction 160 18 5 21 5 G PCR Correction 75 S02 1602 3 GAS Opsi 441 Volume 10179 uL GAS 140psi 3611 Pack Lot 123456 Printer Fix Yes Exp J n 31 2010 Laser Parameters printouts HbCal Life 3 Patient ON copies 1 WOC_SETTLE 0 1000 Calib OFF Ge SAM SETTLE 0 1000 SAM NUM 75 Kl DGIO Pl QC Lockout K2 2248 F2 OG Levels K3 8407 F3 Miscellaneous K4 2500 FAs Units K5 5040 Bos Units Conventional K6 Q090 F6 Temp Celcius K7 49660 EY Time 24 hour K8 25090 FS tHb g dL K9 1320 P Ca mmol L K10 1428 F10 Resolution High KIIS O 004 FLL FL T2505 FI Pump Rate 10 0000 Waste Det 75 LED 40 0000 LED 62 0000 LEDS 50 0000 LED4 50 0000 LEEDS 12 0000 LED6 38 0000 LEDICAL 0 0 LED2CAL LEDSCAE Communications LEDACAL Baud 9600 LEDSCAL Format RS232 ASCII LED6CAL Language English Backlight Auto Off 60 minutes Security Password ENABLED Correlatio
72. 2 Mov Select Auto OC Level and Date Range 1 2 3 All S i Start Date Edt End Date Edt Cancel OK Fig 4 8 Select Date Range Once enabled the OPTI R will ask if you would like to run a Stat sample after calibration and after each level of Auto QC during pack and cassette installation The OPTI R will allow a 3 minute window to run a Stat sample before moving on to the next operation If lt Print Auto QC Report gt is enabled Fig 4 6 the Auto QC results will be printed after completion of each Auto QC measurement Press ES to save changes or press QNe to move on to page 5 of Auto QC setup Adjust Auto QC Oxygen Target for High or Low Altitudes This menu allows you to change the PO Auto QC target by entering an offset value The target may have to be changed at very high and low altitudes An offset value can be entered for levels 1 and 3 only The user should establish the offset value l Select the level of Auto QC to be adjusted level 1 or level 3 Fig 4 7 Press Edit to enter the offset To lower the target enter a negative value and to raise the target enter a positive value Press el Som to save changes Select Date Range for Auto QC Statistics Report This menu allows you to specify the date range for statistical analysis of Auto QC data Fig 4 8 l Select the level of Auto QC to be analyzed or select lt All gt to analyze all 3 levels Press Edit
73. 4 12 Assay ranges entering 4 7 Audible alarm Beep adjustment 3 16 Auto QC measurements 4 9 options 4 5 oxygen target adjust 4 6 ranges ajdust 4 5 reports printing 4 15 scheduler 4 4 setting up 4 4 statistics report 4 6 B Backlight auto off 3 16 Bar code gas bottle 2 6 6 13 QC material 4 7 scanner cleaning 7 7 scanner description 1 5 test 7 20 Barometric pressure entering 3 15 range A I selecting units 3 10 unit conversion A 8 verifying 7 17 Base excess 8 9 calculation A 9 A 10 reference ranges A 5 Bicarbonate actual 8 9 actual reference ranges A 5 acutal calculation A 9 standard 8 9 standard calculation A 9 standard reference ranges A 5 Blood collection and handling 5 1 8 3 volume required 5 3 8 6 Buffer bases 8 9 calculation A 10 reference ranges A 5 C Calcium See Ionized Calcium Calculated parameters 3 6 A 7 Calculated values 8 9 A 4 Calibration 4 1 8 9 data export 4 17 description 4 1 diagnostic report print 7 33 gas bottle 1 8 8 13 master 4 18 6 17 quarterly tHb 6 1 reports D 6 D 7 report setup 3 14 tHb troubleshooting 7 40 touch screen 7 25 verification 4 3 Calibrator cassette 1 8 8 13 report D 8 Capillary tubes 8 3 attach sample 5 4 Operator s Manual OPTI R Analyzer INDEX sample collection 5 2 5 7 8 3 Carbon dioxide partial pressure PCO2 clinical significance PCO2 1 correlation to other methods PCO2 2 linearity PCO2 2 measurement principle PC
74. 92 168 1 101 Activity E 7 Sent SS e 4 Received m Iw DN Packets 1432 2534 3 ve Ta Home Fig 7 31 Ethernet Test The purpose of this test is to check for proper functioning of the Ethernet interface From the Ready display press System Manager gt lt Diagnostics gt In the lt Diagnostics Sensors gt screen press 2 Next repeatedly to access the Tests screen Page 5 of 5 Press Ethernet to start the test Fig 7 29 e tis important to have the network cable connected Fig 7 30 e Press n and the system will send out data and check if they are received Fig 7 31 e Press Q UP to return to the Tests screen Operator s Manual OPTI R Analyzer 7 2 19 Checking the Pump Flow System gt Diagnostics 12 Nov Tests Page 5of 5 Barcode Printer Optics Gas Test Pump Display Touch R5232 Ethemet Print Eror Report p 3 Back E3 Next Q ve firm Fig 7 32 Flow Test IFlow Test Insert Cassette o Fig 7 33 Insert Cassette Flow Tost Flow Test in Progress Fig 7 34 Flow Test Flow Tost Result Pass o l Fig 7 35 Flow Test Pass Flow Test Result Fail OK Fig 7 36 Flow Test Fail 7 DIAGNOSTICS AND TROUBLESHOOTING This option is designed to test the OPTI R fluidics From the Ready display press System Manager gt lt Diagnostics gt In the Diagnostics Sensors gt screen pr
75. Blood Gas Systems OPTI R Analyzer Operator s Manual v gt OPTIMedical kS OPERATOR S MANUAL REVISION LOG Please record any changes made to this manual mmm mo m mem mem UniddperCOONO wm Wegen Nwmp UiipwCO 10815 omme rm omme pate perco 00033 rem Immo zem Irmeennm fe Am Veto CELL Proprietary Rights Notice 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 provided in any written license agreement from OPTI Medical Systems O 2012 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 gael OPTI Medical Sy
76. C measurement e If error persists go to fluidics troubleshooting section 7 3 1 During the wash the fillport could not be cleared of sample fluid e Remove the sample if still attached and press OK to clear the error e If problem persists go to lt System Manager gt Utilities and initiate a Master Calibration The waste sensor is unable to detect fluid movement e Cycle power and check if error recurs e Replace cassette see Section 6 5 1 Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING NotReady 1040 FN Ge me The analyzer was unable to detect the wash buffer Vi Gas Not Ready e Replace the fluid pack If the error persists Buffer Not perform Fluidics Troubleshooting section 7 3 7324 Detected QC System Manager Manager Manager NotReady A 1040 12Nov Samples This message is displayed if any of the parameters Pack A of any of the AQC levels failed the range To determine which AQC level and which parameter Gas Not Ready Failed AQC failed go to lt Data Manager Auto Qc 7324 Level s 1 3 Select the failed level and view the results or print Nat vent the Auto QC report Rerun AQC e Rerun the failed AQC level Data QC System i Manager Manager Manager e Ifthe problem persists repeat pack installation ea with the currently installed pack and cassette Ek The cassette and pack do not need to be
77. C data l In the Ready display select Data Managers Press Control Fig 4 35 In the Data Control Measurement screen Fig 4 36 press the V button to display the Control results Fig 4 37 Use the Up land 09 buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 4 36 To print groups of results highlight the f rst measurement to be printed press Qe then select the last measurement to be printed AII the measurements in between will be selected Press e to select all results d m Print ii uu Press to print your selection Press the Statistics button and select the levels for which statistics are to be printed After printout the database can be deleted by pressing p lt Delete Before the database is deleted enter the password to initiate the procedure if a password has been activated under lt Setup gt Press pHome to return to the lt Ready gt display Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 54 Sending Data to a Computer Ready 10 40 12 Nov Measurements Diagnostics Patient Control Install Slope Auto QC Data Calibration Print Miscellaneous Re ports Configuration Fig 4 38 Select Data Data gt Control Measurement Ready 10 40 12 Nov y pul De oo ooo i ae ow T mes ml T eae sas 3
78. Fig 7 15 Optics Test A Insert Calibrator x Fig 7 16 Insert Calibrator SR Test in Process Fig 7 17 Optics Test e Remove Calibrator Fig 7 18 Remove Calibrator Operator s Manual OPTI R Analyzer Press lt Optics gt to start the test Fig 7 15 Insert a calibrator cassette and press OK Fig 7 16 The system will now check the optics Fig 7 17 At the completion of the test a printout of the results will be printed and the lt Remove Calibrator gt message will be displayed Fig 7 18 7 23 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 13 Gas Test System gt Diagnostics Not Ready 10 40 12 Nov Tests Page 5of 5 Barcode Printer Optics Pump Display Touch RS232 Ethemet Flow Test PE Back ES Next or ef Fig 7 19 Gas Test 7 24 The lt Gas Test gt Fig 7 19 is designed exclusively for use by authorized OPTI Medical personnel to check for leaks in the gas system NOTE This test will last for 2 hours It can only be interrupted by switching the analyzer off Operator s Manual OPTI R Analyzer 7 2 14 Checking the Pump Motor System gt Diagnostics Not Ready 10 40 12 Mov Tests Page 5 of 5 Barcode Printer om Optics Display Touch UE RS232 Ethemet Flow Test tata go SE SIS IR Gm Up Fy Home Fig 7 20 Pump Motor Test Pump Tast NN Pump Speed 800 Fig 7 21 Pump Speed 7 2 15 Checking the Display
79. O2 1 measurement range PCO2 1 precision and recovery PCO2 2 reference intervals PCO2 1 references PCO2 3 reproducibility PCO2 1 temperature corrected A 12 Cassette calibrator description 1 8 8 13 calibrator measurement 6 1 fillport description 1 7 sensor changing 6 7 sensor description 1 7 8 13 sensor installing 2 7 valve drive checking 7 19 Classifications A 7 Cleaning routine performing 6 16 ComfortSamplers 5 2 8 4 Communications setting up 3 17 Compact Flash Card slot CF Slot description 1 6 Configuration report 7 35 Consumable items 10 2 Consumables levels checking 7 17 Control Material setting up 4 7 Control Reports External printing 4 16 Conversion units A 8 Cooling fan checking 7 18 Correlation factors setting up 3 9 Correlations See Linearity Customization 3 1 INDEX D Data management A 6 manager 2 11 3 1 patient enter 5 6 recording and evaluating 9 2 transfer to computer 4 17 Daylight savings time setting 3 2 Diagnostic reports Auto QC 7 31 calibration 7 33 control 7 32 patient 7 30 Diagnostics 7 1 7 15 Dimensions and weight A 7 Display test 7 24 E Error displays 7 1 Error report printing 7 29 Ethernet interface port 1 6 test 7 27 Event Log 7 34 F Factory settings checking 7 19 Flow test 7 28 Fluidics troubleshooting 7 36 Fluid Pack changing 6 10 compartment 1 6 description 1 8 8 13 installing 2 5 G Gas bottle changing 6 12 description 1 8 installin
80. OK 4 11 4 CALIBRATION AND QUALITY CONTROL 4 12 QC Control Control Information Correct Lot XXXXXX Level X e Fig 4 22 Confirm Lot Number QC Controls Fig 4 25 Attach Capillary Tube 5 Press Yes if the lot number is correct Fig 4 22 If a new lot number of QC material is entered make sure the ranges have been entered into the system prior to running a sample See Section 4 5 1 2 If the password function is enabled you will be asked for it before deleting the database for the old lot number 6 Itis time to place a sample Fig 4 23 NOTE Remove an ampoule from the box of controls and shake gently to resuspend the scattering particles being careful not to heat it with your hands Do not shake ampoule vigorously Excessive bubble formation may affect results Gently tap the head of the ampoule with your fingernail to remove any liquid Carefully open the ampoule by breaking off the top CAUTION Protect your fingers by using gloves or tissue while breaking ampoule Aspirate directly from the ampoule or use a capillary or syringe to withdraw a small amount of control material from the ampoule for aspiration Best results are obtained from direct aspiration from the ampoule via the syringe adapter To accomplish this insert the syringe adapter in the cassette fillport and hold the ampoule at a 45 angle making sure fluid is always in contact with the
81. OPTI R Analyzer 3 CUSTOMIZATION The lt OP IDs gt menu is used to enter Operator identification IDs and password PIN With this feature enabled the system will lock out unauthorized users from operating the analyzer e Select lt OP IDs gt in the lt Security gt menu Fig 3 26 e Select lt Secure Operator ID Enable gt NOTE If you do not select this option the Secure Op IDs gt feature is turned off and operators will not be required to enter their PIN numbers to operate the analyzer 1 Press to enter the Operator ID number up to 11 digits and a unique 4 digit personal identification number PIN to be added to the list of authorized users The analyzer can store up to 300 Operator IDs and associated PINs NOTE The 4 digit PIN must be unique and will be required by the operator to access analyzer functions The Operator ID number will be printed on all reports associated with their PIN OR 2 Select an Operator ID number to be deleted from the list of valid users currently stored in memory and press the gt lt Delete button to remove the operator ID from memory OR 3 Press the GP button to print the list of all operator IDs along with their associated PINs as currently stored in memory 4 Press f Home to return to lt Ready gt 3 13 3 CUSTOMIZATION 3 3 2 5 Setting the Printer 3 14 Cum 10 40 12 Nov Customize Patient Information Measured Cal
82. On Pump ELECTROLYTES Na 140 2 mmol L Barometer 739 6 mmHg K 3 67 mmol L Operator ID 12345678901 Ca 1 47 mmol L S N 1234 LOT 123456 nCa 0 97 mmol L REFERENCE RANGES HEMOGLOBIN OXYGEN STATUS DE da 700 tHb 14 4 g dL PCO2 30 50 mmHg Dor 9937 POZ 70 700 mmHg Het ec 43 2 Nat 135 145 mmol L K Sa 5 1 mmol L ENTERED PARAMETERS Cater 1 12 1 32 mmol L Temp e me K tilb 12 0 17 0 g dL Sex Male 502 90 100 Hb Type Adult SamType Art MESSAGES MCHC Ceres O2 Mode Room Air FIO2 Keck RQ 0 84 Operator s Manual OPTI R Analyzer D 1 APPENDIX D REPORT FORMATS Auto QC Measurement Report OPTI Medical OPTI R Controls Measurement DD MMM YY HH MM Level 2 Sample No 2345 PackLot 123456 Exp MMMYYYY RESULT LIMITS OK pH 7 551 7 48 7 56 OK PCO2 69 8 65 75 OK PO2 99 8 96 105 OK Nat 144 2 142 148 OK RE 4 46 4 0 4 8 Cate 1 10 1 0 1 2 tHb 14 7 14 0 15 3 OK 502 98 3 96 99 OK Control Test Result PASS Barometer 744 5 mmHg Operator ID 12345678901 S N 1234 L0ot 1234596 Operator s Manual OPTI R Analyzer Auto QC Statistics Report OPTI Medical OPTI R Controls Statistics DD MMM YY HH MM Level 2 OPTI check QCLOt XXXX Exp MMMYY CassLot XXXXXX S N XXXX Number run 3 Number ok 3 ABG LIMITS pH ud quu vp PCO2 40 0 48 0 mmHg PO 06 0 gt 110 0 mmHg Date pH PCO2 PO2 OK 04May 7 412 43 9 04May 7 410 43 5 05May 7 410 Mean 7 411 43 SD 0 002 1 CVS 0 0053 Electrolyte L
83. Patient Diagnostics Calibration Henort D 8 E ele ele EE EAE EATA ENEE NE D 9 comma PANT vr D 10 Configuration Report Part 2 EEE EE D 11 ERO PRODO GE D 12 Optics TRE D 13 ODSIator IDO Ropo eE e E E EE E D 14 Operator s Manual OPTI R Analyzer A i APPENDIX A TECHNICAL SPECIFICATIONS APPENDIX A TECHNICAL SPECIFICATIONS Measurement Range Parameter Display 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 9 99 0 1 0 01 mmol L Ca 0 2 to 3 0 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 R Analyzer A 1 APPENDIX A TECHNICAL SPECIFICATIONS Operating Parameters Minimum Sample Size Sample Type Sample Application Sample Input Analysis Time Ambient Temperature Range Relative Humidity Range Type of Measurement Input Values A 2 Patient ID Operator ID Accession Number Patient Temperature Patient Sex Date of birth Hemoglobin Type Puncture Site Bypass Sample Type Total Hemoglobin tHb Mean corpuscular hemoglobin concentration MCHC 125uL heparinized whole blood plasma or serum syringe capillary or ComfortSampler automatic a
84. R Analyzer 9 1 9 LINEARITY AND CORRELATIONS 9 3 Performing a Patient Analysis l From the Ready display press lt Run Sample NOTE Prior to analysis the sample must be mixed thoroughly to achieve a uniform distribution of red blood cells and plasma Improperly mixed blood may produce variable results for all analytes The specimen should be gently rotated for a minimum of one minute prior to analysis and then introduced into the analyzer immediately Any delay in the introduction of the sample into the predicate device and the OPTI R analyzer could cause extreme differences in the measurement results Please follow the CLSI correlation and precision guidelines 2 Using the sample collected in the heparinized syringe run the patient sample on the reference device Remove air from the syringe place a red syringe adapter onto the end of the syringe attach the patient sample with syringe adapter to the cassette fillport and press lt OK gt The OPTI R will then display Sample Aspiration In Progress Please Wait gt Once the sample has been completely aspirated from the syringe remove the syringe from the analyzer when prompted and press OK 3 Press Patient Info to edit enter patient and sample information during the OPTI R Analyzer measurement cycle See Chapter 5 of the Operator s Manual for more detailed information 4 Upon completion of both analyses record the results displayed on the reference ana
85. ROR Unstable Sensors OK E ERROR Short Sample K Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The cassette was not properly placed into the chamber e Open the SMC cover remove and reinsert the cassette and close the cover OR e Press Cancel to abort The cassette was not properly placed into the chamber e Press OK discard the cassette and repeat test with a new cassette The cassette or its packaging is defective e Press OK discard the cassette and repeat test with a new cassette Make sure to wipe the new cassette dry before inserting it into the SMC 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 UK and let instrument clear the error through automatic cassette wash e Check the sample for contaminants e Rerun the sample The system was not able to aspirate enough contiguous sample fluid to cover the optode sensors after multiple aspiration attempts e Press OK and let instrument clear the error through automatic cassette wash e Check sample for sufficient volume and air bubbles e Rerun the sample 7 5 7 DIAGNOSTICS AND TROUBLESHOOTING ERROR Wash Buffer Failure Replace Fluid Pack O A ERROR Auto QC Level 1 failure OK i Fry ERROR Fluid Pack used OK FY ERROR Invalid Fluid Pack OK FY ERROR Invalid Fluid Pack
86. STOMIZATION Your OPTI R has an RS232 standard serial interface with a baud rate fixed at 9600 and an Ethernet port These ports may be configured for ASCII and ASTM output 3 3 2 9 1 Configuring the Communication Format 1 From the Ready display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press lt Hardware gt Interface gt 3 The lt Interface gt screen contains the following options Fig 3 34 e lt External Barcode Enable gt e lt Format gt lt ASCII gt lt ASTM gt or CF e ASCII Format gt Data in easy to read OPTI Medical custom format The OPTI R exports data string identical to the internal printer output e lt ASTM Format gt Complies with ASTM standard with handshaking and data formatting e CF Compact Flash is used for archiving data to a Compact Flash Card An Export Kit is available BP7140 with a properly formatted card instructions and card reader By selecting Comma or lt Semicolon gt data can be easily exported into a PC e lt Link gt Select Serial or Ethernet 4 The Ethernet screen Fig 3 35 is used to configure Ethernet settings Format IP Type IP Address Subnet Mask gt UDP Portz TCP Port and Host IP 5 Press p se to accept the changes 6 Press Q UP to return to the Setup screen or f Home to return to lt Ready gt 3 CUSTOMIZATION 3 3 2 10 Selecti
87. Security Fig 3 23 The OPTI R has a password function which when activated will deny access to the setup menus and certain database functions The correct password will have to be entered to grant access to these menus and functions The password is especially useful to ensure that only authorized operators can alter customized settings The factory default password is 404 The factory set password can be changed to any number between 0 and 9999 up to 4 digits l Select Password Enable in the Security menu Fig 3 24 You will then be able to enter a number 1 4 digits in the Setup PW field 2 Press Edit to enter the numbers and press S kW Save to accept the changes CAUTION Make sure the password is kept confidential and in a safe place Passwords can not be retrieved 3 Press Q UP to return to the Setup screen or f Home to return to Ready 3 11 3 CUSTOMIZATION 3 3 2 4 2 Selecting QC Lockout Number of QC 1 2 3 Levels S Bhr ahr 24hr de Time Interval e C e C Fig 3 25 Select QC Lockout 3 12 This menu allows the hospital to lock out operators unless some form of QC has been run QC Lockouts do not apply to Auto QC settings When activating QC lockouts you will be required to perform external OPTI CHECK measurements before a patient measurement can be performed Each facility should develop their own policies on the frequency and type of QC
88. Syringe adapter description 1 7 8 13 Syringes 5 1 8 3 System manager 2 11 utilities 6 16 T Taking out of operation 6 18 Technical assistance 10 3 Technical specifications A 1 Temperature corrected values A 4 Temperatures system checking 7 16 Test conditions 5 3 8 6 Thermal printer See Printer Time and date setting 2 3 3 1 Total CO2 8 9 calculation A 9 reference ranges A 5 Total hemoglobin concentration ctHb THB SO2 1 clinical significance THB SO2 1 correlation to other methods THB SO2 4 interferences THB SO2 3 INDEX linearity THB SO2 4 measurement principle THB SO2 2 measurement range THB SO2 2 reference intervals THB SO2 2 references THB SO2 4 reproducibility THB SO2 3 Touch screen description 1 4 test 7 25 Troubleshooting 7 1 7 36 Fluidics 7 36 procedure for tHb SO2 7 40 U Units of measure conversion A 8 defining 3 10 used for calculations A 8 Utilities 6 16 V Valve drive checking 7 19 Valves checking 7 18 Versions checking 7 15 W Warranty registration 10 4 Whole blood samples 5 3 Operator s Manual OPTI R Analyzer
89. TI R Cassette and projects from the chamber for easy automatic sampling Fig 1 13 For sampling with a syringe use the optional syringe adapter BP7600 NOTE DO NOT INJECT the sample It will be aspirated automatically 1 7 1 INTRODUCTION 1 8 OPTI R Fluid Pack Fig 1 14 Fluid Pack Gas Bottle Fig 1 15 Gas Bottle Calibrator Cassette Fig 1 16 Calibrator Cassette Congratulations The self contained OPTI R Fluid Pack uses a unique design to prevent waste spillage The waste is converted into a gel as it enters the fluid pack to eliminate the possibility of waste spillage during pack disposal The OPTI R Fluid Pack is connected to the rear of the analyzer Fig 1 14 During the master calibration the OPTI R 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 15 The reusable Calibrator Cassette Fig 1 16 is used for the quarterly calibration of the OPTI R Analyzer See Section 6 3 Quarterly Maintenance Running the Calibrator You have just learned the basic components of the analyzer and are now ready to install your system Operator s Manual OPTI R Analyzer 2 SETUP 2 SEIP ame wire po 2 1 2 1 Important Safety InstructionsS x anxrnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnennnennnune 2 1 2 2 ENOS rz Bro reri o sacian
90. VENKEE DUE SKK ER KEINE UE NINE R RR ERE UNERN NEA 6 5 64 1 Replacing Peri Pump Cartridge E 6 5 642 Replacing SMC VO PONS sg Er EE ATSAN ieu los iati 6 6 6 5 As Needed Maintenance rannnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnunnnnnnnnnnuenn 6 7 6 5 1 eene e eh vue 6 7 6 5 2 Changing the Fluid PA kveg dut 6 10 6953 Changing the Gas Bottle rv 6 12 6 5 4 Changing the Printer aper 6 15 6 5 5 Performing Routine Clodio vaere ease tue patUPi uidere 6 16 6 6 System Utilities an rannnnnnnnnnnnnnnnnnennnnvnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnennnennnennnennnunnnnnnnne 6 16 oo H CAND AUF REE EE 6 17 6 6 2 MP E ele len DEE 6 17 006 Taking out of NNN 6 18 6 6 3 1 PANNEN ee 6 18 SEN tele Ee ee 6 19 7 DIAGNOSTICS AND TROUBLESHOOTING 7 1 tl Ui QUILT UU Tm 7 1 td DIAGNOSIS eres MERGE 7 16 EVNE 7 16 7 2 2 Checking System Temperatures cccccccceececssceceeeceeeecseecocecaeeccaneceeeeseeesoueesaeeeses 7 17 gt GENE LEDS veden 7 17 724 Verifying Barometric Pressure eegent Sekt deetEe Eege Eder g 7 18 7225 Checking Consumable Levels oiiiecicenatenserecundounsaddinndcceiieteatobermudersdedeatedotdeclsadedmevebeenss 7 18 1 20 Che king the NNN sek en 7 19 EE EE EEE EN 7 19 120 Checking the Factory SAS 7 20 7 2 9 Checking the Valve DIVE menes sedsj lekdnedikee eege 7 20 7 2 10 Checking the Bar Eegeregie 7 21 1 2 11 Checking the Printer erre 7 22 212 ENE NNN MEN EK
91. YTES OL pH 1 SE PCO2 1 o PO2 1 ere NE e A Na 1 FOU SS UD EE K 1 TANN dp PT EC Ca 1 Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saraton C96 E THB SO2 1 SOFTWARE UPGRADES TECHNICAL BULLETINS Operator s Manual OPTI R Analyzer V TABLE OF CONTENTS APPENDIX A TECHNICAL SPECIFICATIONS A 1 Mei A 1 PA PT A 1 TU Eee A 1 g SJ Ei 6 p QS EEE NE A 1 PETN A 2 fel AEE EEE EE NE A 2 Temperature Corrected Values A 4 RETTET A 5 RI e EE A 6 KEEP TN NTN A 6 Mains Supply for External Power Supply rarrrnnrnanernrennervnnrnnnevnnernnennnennnnnnennannnnnnnernnennnernnesnnee A 6 NEVNTE GE dende ke A 6 Dimensions and UV CNC ETT A 7 OE 6 le EE A 7 Calculated Parameters EE A 7 PTE A 7 Units Used in Measured and Input Parameters for Calculatnons A 8 Conversion Table TOT UNIS EEE EE A 8 APPENDIX B MENU STRUCTURE eeeeenen nnn B 1 APPENDIX C MAINTENANCE LOG eren C 1 APPENDIX D REPORT FORMATS esvnnrnnennnrnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnennnr D 1 PCP D 1 Auto QC Measurement e EN D 2 Auto QC Statistics RE DOK dE D 3 AQC Install Slope Measurement Report rrrrrnrnrennnrnnnnevnnrernnrnrarennnennnnernnrnrnnennnnennnennusernsrnnunenn D 4 Controls
92. ablish its own reference interval for PCO as performed on the OPTI R as factors such as altitude can affect such measurements Sample type Range mmHg Whole blood arterial Newborn 27 40 Infant 27 41 Adult male 35 48 Adult female 32 45 Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI R instruments PCO is expressed in mmHg Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level 1 69 4 1 17 1 7 0 39 0 6 1 69 2 4 Level 2 43 2 0 91 1 2 0 48 1 1 1 51 3 5 Level 3 23 9 0 50 2 1 0 94 4 0 1 45 6 2 Serum 40 4 0 93 2 3 0 22 0 5 1 15 2 8 Reduced Bovine Hemoglobin Sol 43 7 0 88 2 0 0 71 1 6 0 87 2 0 Operator s Manual OPTI R Analyzer PCO ANALYTES All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method 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 2 replicates we
93. al OPTI R Analyzer 3 CUSTOMIZATION 3 3 1 2 Selecting Which Parameters Are Blanked Disabled Not Ready 10 40 12 Nov Customize Patient Information Patient Ent Measured Calculated Parameters Parameters a Miscellaneous Normal Ranges Correlation Units Alarm Limits Security Printer Hardware Q Up Fy Home Fig 3 10 Measured Parameters System gt Setup gt Measured Parameters pH P PCO2 m PO F Na E K E Ca p tHb 507 cancel sa Q Up Home Fig 3 11 Select Allow Blanking Operator s Manual OPTI R Analyzer In the lt Measured Parameters gt menu you can enable parameter blanking and disable certain parameters from being reported on the analyzer From the lt Ready gt display select lt System Manager gt and lt Setup gt In the lt System Setup gt menu press lt Measured Parameters gt Fig 3 10 Press lt Allow Blanking gt to allow parameter blanking Fig 3 11 If blanking is enabled the user is prompted to choose which measured parameter will be disabled or removed from the record after each patient sample measurement If for example Ca is disabled this result will not appear in the stored patient results or on the printout The next option lt Reported Parameters gt allows you to permanently disable the selected parameters from all patient measurements Press fel Sve _to save the settings Press C xb lio return to the l
94. al 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 1s 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 8 4 6 OPTI Medical ComfortSamplers Blood may be collected for analysis on the OPTI R 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 8 4 7 Handling and Storage of Samples Please refer to NCCLS 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
95. alid bar code e g cassette expired Read the message on the Manual ante analyzer display for detailed information See Chapter 7 Troubleshooting Fig 6 19 Scan cassette bar code Operator s Manual OPTI R Analyzer 6 7 6 MAINTENANCE 6 8 Syste m gt Utilities gt New Cassette Install Scan Next Barcode Now 8 Next turn the cassette pouch over and scan the bar code labeled Scan B Fig 6 20 9 A beep and a green status light indicate a valid bar code Manual Cancel Fig 6 20 Scan second bar code Syste m gt Utilities gt New Cassette Install Open Cover 10 Slide the latch up and press the release button to open the Sample Measurement Chamber SMC Fig 6 21 Cancel Fig 6 21 Open SMC Cover Syste m gt Utilities gt New Cassette Install 11 Insert the cassette as follows Open Pouch and Wipe Cassette 12 Open the OPTI R Sensor Cassette packet and remove the cassette from the pouch Fig 6 22 C s CAUTION Do not tear the two bar codes when 7 opening the cassette pouch Insert C tte i l iiaa 13 Gently wipe both sides of the cassette with a SA clean dry cloth to remove excess molsture di 14 Insert the cassette in the chamber and press w down to ensure it is properly seated SEN Fig 6 22 Fig 6 22 Insert Cassette Operator s Manual OPTI R Analyzer 6 MAINTENANCE Syste m gt Utilities gt New Cassette Install Close Cov
96. amic Storage capacity is gt 300 patient records QC data for 2 months at 3 levels RS232C Pin Configuration 5 4 3 2 1 6 00060080 e oe o o 9 8 7 6 REAR VIEW OF OPTI R Pin 1 No Connection Pin 2 RxD Pin 3 TxD Pin 4 DTR Pin 5 GND Pin 6 DSR Pin 7 No Connection Pin 8 CTS Pin 9 No Connection Mains Supply for External Power Supply 100 10 VAC to 240 10 VAC 50 60 Hz Overvoltage Category Category II when connected to a branch circuit A 6 Operator s Manual OPTI R Analyzer Dimensions and Weight Height 4 7 Width 14 2 Depth w o Fluid Pack 9 1 with Fluid Pack 15 1 Weight w o Fluid Pack 10 Ibs with Fluid Pack 12 lbs Classifications Approvals Mode of Operation Laser Classification Explosion Protection Calculated Parameters APPENDIX A TECHNICAL SPECIFICATIONS 12 0 cm 36 2 cm 23 0 cm 38 0 cm 4 5 kg 5 5 kg UL3101 1 CAN CSA C22 2 NO 1010 1 CE FCC Class A 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 R are based on the NCCLS Standard C12 A when available Temperature r er T ec 32 r ec eit ulv rbr 32 Burtis AB Ashwood ER Tietz Textbook of Clinical Chemistry 2 Ed Philadelphia W B Saunders 1994 p 2165 Operator s Manual
97. ample into the cassette and across the optode sensors Fluorescence emission 1s then measured after equilibrating with the blood sample After completion of the measurement the ananlyzer will wash the cassette and perform a gas calibration The Fluid Pack contains the wash solution and a waste pouch Operator s Manual OPTI R Analyzer 1 1 1 INTRODUCTION 1 3 1 2 Contents Before you begin installing your OPTI R Analyzer take a moment to look over the contents to ensure you have the following e Power supply with power cord e Shutdown pack shutdown cassette and 2 shutdown bottles e Syringe and stylette for troubleshooting e Gas bottle e Thermal printer paper e Calibrator cassette Cal NOTE The Cal Cassette is located inside the door for the thermal printer You will also need the following consumables prior to setup e OPTI R cassette e OPTIR Fluid Pack e OPTI Check Quality Control Material Operator s Manual OPTI R Analyzer 1 INTRODUCTION 1 4 Analyzer Components Before setting up the OPTI R Analyzer it is important to familiarize yourself with the analyzer s components Printer On Off Switch Fluid Pack Touch Screen Display Status Light Sample Measurement Chamber SMC Gas Bottle Bar Code Scanner On Off Switch Fig 1 1 OPTI R Major Components Operator s Manual OPTI R Analyzer 1 3 1 INTRODUCTION 1 4 Touch Screen Fig 1 2 VGA and Touch Screen
98. amples 0 2 Please refer to NCCLS 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 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 Operator s Manual OPTI R Analyzer 5 SAMPLE HANDLING AND PATIENT TESTING PO changes due to oxygen consumption may be influenced by several factors including white blood cell count reticulocyte count storage
99. amples 50 patient or 45 QC measurements or its in use expiration 7 days this display appears Fig 6 17 Pack Ha Gas 50 Not Ready Cassette Expired P324 Install Cassette QC System Data Manager Manager Manager 12 Nov 10 13 Cassette Expired Fig 6 17 Installing new cassette Baro 1 Incase the cassette is expired press Install Cassette to install a new cassette System Utilities Not Ready 1040 12Nov 2 Otherwise go to lt System Manager gt Installation Utilities Utilities gt and press Cassette on the Component Insjalletie Installation tab Fig 6 18 Fluid Pack Cassette 3 Remove old cassette C RH Repeat Pack CAUTION When used the OPTI R Cassette Install i contains human body fluids and must be treated as medical waste Handle with appropriate care and dispose of in accordance with local regulations Up Zo Home Fig 6 18 Installing new cassette 4 Scan the bar code on the OPTI cassette package EE by holding it 2 3 inches 5 8 cm from the bar Not Ready 1040 12 Nov code scanner located on the bottom right hand corner of the analyzer until the bar code labeled Scan is recognized Fig 6 19 Scan Cassette Barcode 5 Thered line from the bar code scanner should s I cover the entire bar code ME No 6 A beep and a green status light indicate a valid bar code 7 Ared status light indicates an inv
100. apillary a syringe and adapter or ComfortSampler attach the sample to the cassette fillport Fig 5 3 and Fig 5 4 and press OK to start the sample measurement The sample is then aspirated 5 5 5 SAMPLE HANDLING AND PATIENT TESTING s When using a syringe make sure the red syringe adapter is not touching the syringe plunger WARNING Do not inject the sample It will be automatically aspirated Measure ment 4 After the sample has been aspirated remove Please Remove Sample the sample and confirm by pressing OK Fig 5 5 Fig 5 5 Remove Sample Measurement Next the sample is measured During the measurement the status light is blinking and a progress bar is displayed Fig 5 6 Cassette Measurement In Progress Please Wait Measuring 5 To enter patient information while measurement 40 is in progress press lt Patient Info gt Fig 5 6 d Patient info Fig 5 6 Sample Measurement 5 6 Operator s Manual OPTI R Analyzer Measurement Measuring 10 40 12 Nov Edit Patient Data or Press Home for Ready Last Patient e EE Patient Info Q Fig 5 7 Edit Patient Data Measurement gt Patie nt Data Measuring Operator ID nm Heat Ve Ll e Feri fs eat DOE ea Temperature mH heat tHb fed FIO2 IL Edit Sex Unknown Male Female i c Back Page 1of7 E Next Finish Fig 5 8 Edit patient data 1 Meas
101. ar 1436 Cassette Detect 760 lon 1246 d ger Closed m 2 Miscellaneous Barometric Pressure refer to Setup Section 3 3 2 6 Entering the Barometric Pressure for setting the barometer 7234 mbar kFa ST sc Fig 7 5 Barometric Pressure 7 2 9 Checking Consumable Levels System SD gnosis The lt Consumable Status gt screen Fig 7 6 Not Ready 10 40 12 Nov allows you to check the fluid levels remaining in Consumable Stetus powers the Fluid Pack the number of samples and usage Sur ice vu time left on the sensor cassette number of QC ow Level solution sw Mid Level Solution g9 measurements left and gas pressure remaining in the High Level Solution 9955 Ge gas bottle Samples Left 25 f Time Left 3 5 days From the lt Ready gt display press lt System QC Measurements Samples Lett 25 Manager gt Diagnostics aa 29 In the lt Diagnostics Sensors gt screen press QNex to access lt Consumable Status Back Next Ul J C With a new Fluid Pack Gas Bottle in place the level Ow Ep Home should be approx 99 with Fluid Pack Gas Bottle removed it should be 00 Fig 7 6 Reagent Levels e For instructions on installing a new Fluid Pack gas bottle and sensor cassette see Section 6 Maintenance 7 18 Operator s Manual OPTI R Analyzer 7 2 6 Checking the Cooling Fan System gt Diagnostics vahe 1 C Valve Z Valve 3 Valve 4
102. ata User Field 1 ed User Field 2 Edi User Field 3 Edit Back Page 7 of 7 Next Finish Fig 5 14 Edit patient data 7 Operator s Manual OPTI R Analyzer 5 SAMPLE HANDLING AND PATIENT TESTING 11 The next set of patient data contains the following information Fig 5 12 PEEP default value 0 CPAP default value 0 Rate f default value 0 bpm Liter Flow default value 000 00 Lpm TVol VT default value 0 mL MVol VE default value 0 L PIP default value 0 Pplat default value 0 PS default value 0 12 Press 52 Next again and select the following Fig 5 13 BiLevel Pressure default value 0 00 0 00 I E Ratio default value 0 13 The last set of patient data contains the following information Fig 5 14 User Field 1 9 alphanumeric characters User Field 2 9 alphanumeric characters User Field 3 9 alphanumeric characters 14 If no value is entered a default value will be used and printed 5 9 5 SAMPLE HANDLING AND PATIENT TESTING Measurement gt Results um pas OLEAG Measure d Calculated 70 6 mmHg 70 5 mmHg 126 0 mmol L 3 01 mmol L 1 55 mmol L _ 8 1 g dL 20 28 4 mmol L 26 2 mmol L 20 7 mmol L Fig 5 16 Calculated parameters When the analysis 1s completed the status light stops blinking and the instrument alerts you that the measurement has been completed with a beep A
103. ator s Manual OPTI R Analyzer 3 CUSTOMIZATION Correlation factors let you correlate results from your OPTI R to other Blood Analyzers Correlation factors are available for pH PCO PO Na K Ca tHb and AC NOTE Slope is a multiplicative factor and Offset is an additive factor using the following formula Correlated value Raw value slope offset 1 From the Ready display select System Manager and Setup 2 In the System Setup menu press Correlation Fig 3 18 3 Select the numbers you want to change by pressing Edit Fig 3 19 Enter the new numbers 4 Press lt Factors 2 gt to go to the next screen Fig 3 20 5 When entering the actual offset value select whether it is an additive or subtractive value using the keys NOTE The factory setting is 1 000 for all slopes and 0 000 for the offsets This deactivates the correlation factors 6 Continue through the other parameters setting their correlation factors as above 7 Press Save to accept the changes 8 Press UP to return to the Setup screen or f Home to return to lt Ready gt CAUTION Since altering the correlation factors will alter your measurement results be very careful to enter the correct values and confirm the settings by running at least 10 comparison measurements between the OPTI R and the instrument to which it is to be correlated 3 9 3 CUSTOMIZATION 3 3
104. ax for 400ms 850 nm Laser 40 Microwatts max for 400ms Caution Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure Operating Safety Information Symbol Definitions The symbols described below are used on the packaging of OPTI R related products Symbol 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 this symbol can be considered recyclable This symbol is located on all applicable product packaging WEEE Symbol This product complies with WEEE Direct
105. by the Stern Volmer equation I I 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 Measurement Range Range Resolution Low High Units 10 to 700 1 0 1 mmHg Reference Intervals Arterial oxygen tension PO is dependent upon the inspired oxygen tension as well as various physiologic variables and the administration of oxygen is common in the treatment of patients in need of blood gas analysis Hypoxemia is defined as an arterial PO below an acceptable range while breathing room air with about 21 oxygen at sea level Increasing altitudes above sea level will produce lower inspired oxygen tensions and therefore lower arterial PO values Below are listed acceptable arterial oxygen tensions at sea level while breathing room air Sample type Range mmHg Whole blood arterial Birth 8 24 I day 54 95 2 days 60 yr 83 108 gt 60 yr gt 80 gt 70 yr gt 70 gt 80 yr gt 60 gt 90 yr gt 50 Each laboratory should establish its own reference interval for PO as performed on the OPTI R as factors such as altitude can affect such measurements Operator s Manual OPTI R Analyzer PO2 1 PO ANALYTES Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from I run
106. 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 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 I 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 sedimentation may occur very quickly in syringes containing pathologic blood samples and may adversely affect the measurement of ctHb in any analyzer To
107. ce on the pump motor shaft to align with the flat surface of hole keyway in the pump cartridge roller Press the cartridge firmly down until it is fully seated on the housing of the instrument Fig 6 14 Fig 6 14 Install New Cartridge Operator s Manual OPTI R Analyzer 6 5 6 MAINTENANCE 5 Press the pump cartridge roller down until it firmly seats on the shaft of the pump motor Fig 6 15 6 Perform a Master Calibration to ensure correct operation Make sure the pump rotates smoothly without excessive noise Fig 6 15 Push on Pump Roller 6 4 2 Replacing SMC I O Ports To change the SMC I O ports l Open the SMC cover Remove the black I O ports by grasping them with a hemostat or tweezers and firmly pulling upward Fig 6 16 Discard the old parts 2 Install the new SMC I O ports with the rounded surface pointing up and press them into the recess When fully seated the I O ports are approximately 1 8 inch 3mm above the surrounding surface Fig 6 16 SMC I O Ports 3 Perform a lt Master Calibration gt to ensure correct operation Make sure the pump rotates smoothly without excessive noise 6 6 Operator s Manual OPTI R Analyzer 6 MAINTENANCE 6 5 As Needed Maintenance 6 5 1 Changing the Sensor Cassette NotReady A 1040 12 Nov d Samples When no cassette is present in the sample measurement chamber or the current cassette has A reached the maximum number of s
108. ct Diagnostics gt Event Log gt in the lt Data gt screen Fig 7 50 e Press aPrint to print the event log Fig 7 51 e Press AC Delete to delete the event log Confirm your choice by pressing Yes in the lt Delete the Event Log gt screen Fig 7 52 Up to return to the Data screen e Press 7 35 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 21 6 Configuration Report Measurements Diagnostics Patient Control Install Slope Auto QC Data Calibration Print Miscellaneg D Configuration Fig 7 53 Configuration Report 7 36 This printout reports all settings such as QC ranges reference limits correlation factors patient information printout settings etc e To print a configuration report select Configuration in the Data screen Fig 7 53 e Press Q Up to return to the Data screen NOTE After initial setup a configuration report should be printed and kept in a safe place for later reference Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 7 3 Troubleshooting 7 3 1 Fluidics Troubleshooting This section describes a complete check of the OPTI R fluidics system It identifies leaks and or blockages WARNING During step I through 14 always aspirate the solutions never inject as this could lead to permanent damage to the analyzer and or fluid pack I Install a new pack fluid pack open the SMC and remo
109. culated Patient el Parameters Parameters Miscellaneous Normal Ranges Correlation Units Alarm Limits Patient Reports v pend r calibration Report pend T Reference Ranges 1 Number of Copies e c cancel Defaults fa Save Q Up Home Fig 3 28 Select Print Options System gt Setup gt Printer adr Configuration Printer Location intemal Extemal Both qe C Printer Connection RS232 Ethemet C C Printer Port 9100 Edit Printer IP Address 192 168 1 100 Edit cancel Defaults pl Save Q Up fire Fig 3 29 Select Printer Configuration This menu allows you to program the printing functions of your analyzer e From the Ready display select System Manager and Setup e Inthe System Setup menu press Printer Fig 3 27 In the Settings menu Fig 3 28 you can select to have a patient report printed at the end of each measurement The second option lets you add a calibration report to each patient report The next option lets you add reference ranges to each patient report The last option lets you select how many copies will be printed 1 Select the options to be enabled 2 Press Save to accept the changes 3 Press Up Ito return to the lt Setup gt screen or f Home to return to Ready NOTE This setting affects the patient report only All other print functions are still active even if the patient repor
110. d Storage of Gamples KEEN ENEE 8 4 or Poe 8 5 8 5 1 JM t rials Ee 8 5 ocv MEME OSU COONS m 8 6 OT MT Nese 8 6 094 Calculated cmm R 8 9 55 MUNN 8 9 COU CON PE TER 8 10 8 5 7 Reference Intervals 20 2 0 ccc cece cece seca eeceeee cece eeeeeeeeeeeeeeeeeeeueceueeeeeeeseneeeeeeeeeeeeseneeseneees 8 10 8 5 8 Specific Performance CN r cersicsuuurnvauvsmmmmmmmmnmssmsieituenikmv ninsi de 8 10 SSE ga Gog EE 8 11 EN A8 Me Ee 8 12 8 95 11 OE EE SE 8 13 Operator s Manual OPTI R Analyzer 8 i 8 OPERATING PRINCIPLES 8 OPERATING PRINCIPLES 8 1 Intended Use The OPTI R 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 total hemoglobin concentration tHb and hemoglobin oxygen saturation SO in samples of whole blood and pH sodium potassium and ionized calcium in serum and plasma in either a traditional blood gas clinical laboratory setting or point of care locations by personnel minimally qualified to perform and report these results 8 2 Principles of Procedure Luminescence is the emission of light energy resulting from excited molecules returning to a resting state When luminescence is initiated by light it is commonly referred to as fluorescence When a fluorescent chemical is exposed to light energy of an appropriate color electrons in th
111. d pH Measurement Range Range Resolution Low High Units 0 8 to 10 0 1 0 01 mmol L Operator s Manual OPTI R Analyzer K 1 POTASSIUM ANALYTES Reference Intervals gt Sample type Range mmol L Serum Premature 48 hr 3 0 6 0 Newborn 3 7 5 9 Infant 4 1 5 3 Child 3 4 4 7 Adults 3 5 5 1 Plasma Male 3 5 4 5 Female 3 4 4 4 Interferences The OPTI R K sensor has no measurable interference from Na variation within the range 100 190 mmol L The OPTI R 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 R K sensor has no interference from ammonia or ammonium ion present at normal physiologic levels below 100 umol L At hyperammonemia plasma levels of 300 umol L the OPTI RK sensor will show a potassium offset of 0 4 mmol L and at extreme hyperammonemia plasma levels of 3000 umol L the OPTI RK 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 25 mg dL
112. d pack receptacle Insert the stylette into the bottom four ports Fig 7 58 Caution Do not insert stylette into the top port since this may cause a puncture of the internal waste line I Fig 7 58 Insert stylette into the fluid pack ports 5 Attach the service syringe to the four fluid ports referenced in step 2 Check for the lines to be clear otherwise repeat step 3 and 4 7 3 3 Repair Verification After blockage removal repeat the respective troubleshooting section to make sure the blockage has been cleared For example if QC level 2 solution valve 3 could not be aspirated clear the line with the stylette then repeat step 6 and 7 of the troubleshooting procedure If the blockage removal was successful but QC solutions cannot be aspirated replace the valve cartridge 7 40 Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 7 3 4 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 responsible for the tHb and SO measurements These channels may 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 OPTI CCA TS or OPTI R analyzers and may correct tHb and SO failures 1 Open the SMC
113. data in this section was generated on OPTI R systems with OPTI CHECK Controls run daily to check QC 2 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 8 10 Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES 8 5 9 Limitations The performance characteristics are affected by the following sample considerations The preferred test liquid is whole human blood for all parameters It is necessary to tonometer blood to obtain values to evaluate accuracy of PO and PCO because patient samples must be considered to be unknown Tonometry of blood introduces potential errors unrelated to the blood gas system being evaluated Accuracy of the gas values used temperature control and thermostatting of the tonometer humidification of the tonometry gases duration of tonometry and transfer of the sample from the tonometer to the instrument for analysis are examples of potential pre analytical error pH of blood cannot be predicted in tonometry All tonometered samples analyzed in these studies were analyzed in duplicate on an AVL 995 to establish correlation Precision of PCO and PO measurement as well as pH was evaluated over a 20 day period using two OPTI R 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 R s
114. dure 6 18 Principles of operation 1 1 Principles of procedure 8 1 Printer description 1 5 setup 3 14 test 7 21 Printer paper changing 6 15 installing 2 4 Proficiency testing 4 2 Pump motor test 7 24 Q QC lockouts 3 11 3 12 manager 2 11 overview 4 2 recommendations 4 3 results 4 14 sample measurement 4 11 setup 4 4 Quality control 4 1 8 10 Quality Control Testing 9 1 R Ready display description 2 10 Reference intervals 8 10 ranges A 5 Report formats D 1 Reports diagnostic 7 30 Rilibak Square Mean 4 5 RS232 interface pin configuration A 6 port 1 6 test 7 26 S sample collection devices 5 1 8 3 fillport 1 7 handling 5 1 handling and storage 5 2 8 4 measurement chamber SMC 1 4 patient measurement 5 4 preparation 5 3 requirements 5 1 8 3 whole blood 5 3 secure Operator ID 3 11 setting up 3 13 Security setting up 3 11 setup analyzer 2 1 Shutdown pack 1 7 Operator s Manual OPTI R Analyzer INDEX procedure 6 19 SMC I O Ports replacing 6 6 Sodium Na Na 1 clinical significance Na 1 correlation to other methods Na 4 interferences Na 2 linearity Na 3 measurement principle Na 1 measurement range Na 1 reference intervals Na 2 references Na 4 reproducibility Na 3 spare parts 10 3 Specimen collection and handling 5 1 8 3 Standard pH 8 9 calculation A 8 reference ranges A 5 STAT sample option 2 9 4 5 Status light description 1 4 Supplies 10 1 Symbol definitions VII
115. dware function When this function is enabled the Settings Interface Ethernet backlight of the display will turn off automatically at Barometer Curent Offset the selected time interval Offset 740 mmHg 4 Edit A 1 From the Ready display select EE M System Manager and Setup Beep Volume pid 2 In the System Setup menu press Backlight Auto off Hardware ode 3 In the Settings screen select OFF Qgcance Defaults pl Save Q Up fire Fig 3 33 Backlight Auto Off 3 16 10 Min or 60 Min time intervals for the backlight auto off feature Fig 3 33 Press JW Sae to accept the changes Press Q UP to return to the Setup screen or f Home to return to lt Ready gt Operator s Manual OPTI R Analyzer 3 3 2 9 Setting Up Communications External Barcode Enable r Communication ASCII ASTM CF Format C C c Link Serial Ethemet L Compact Flash Comma Semicolon Delimiter C Kg cancel Defaults fa Save Q Up Home Fig 3 34 Communication Format System gt Setup gt Hardware Nat Ready p Settings Interface Format D IP Type dis IP Address Lg FAST Subnet Mask 55 25575 Fen UDP Port 6700 Edit TCP Port 6700 Edi Host IP 192 168 1 100 Edit Kg cancel Defaults fy Save Q Up gj Home Fig 3 35 Ethernet Settings Operator s Manual OPTI R Analyzer 3 CU
116. e Edit button to call up a numeric keypad that can be used to change the time and date setting To change the Time Format from lt 12 hour gt time units to lt 24 hour gt time units press the respective radio button To change from Standard Time to Daylight Savings Time select the option Daylight Savings Enable gt Press Fl to accept the changes Press Q Up lto return to the lt System gt screen or f Home to return to lt Ready gt Setup menus let you program the setup of the printed reports set up system security and customize several other system features E From the lt Ready gt display press lt System Manager gt to access the lt System gt menu Press lt Setup gt to select this function Fig 3 5 Enter the password 404 if enabled to access the setup functions NOTE If the factory set password was changed enter the currently valid password Operator s Manual OPTI R Analyzer 3 CUSTOMIZATION 3 3 1 Customizing Patient Information 3 3 1 1 Selecting Which Patient Information is Requested and Printed In this function you can define which patient Se ST information is requested during as well as printed M after each measurement Patient Entry easured Calculated Parameters Parameters 1 e From the lt Ready gt display select lt System Manager gt and lt Setup gt em nt 2 Inthe lt System Setup gt menu press lt Patient Security Printe
117. e calibrator cassette with the instrument at all times The unit will now begin printing the Calibrator Report showing both the old and new calibration results and calibration factors Fig 6 11 Operator s Manual OPTI R Analyzer 6 MAINTENANCE 6 4 Semiannual Maintenance Twice a year the peristaltic pump cartridge and SMC I O ports must be replaced to assure that your analyzer operates at peak performance 6 4 1 Replacing Peri Pump Cartridge WARNING Itis recommended that this maintenance procedure should be performed when changing the sensor cassette since it will result in premature expiration of the sensor cassette currently installed in the analyzer To change the cartridge 1 Open the printer cover door The peri pump is located to the right of the printer Remove the pump by firmly grasping the ends of the housing and pulling upward Fig 6 12 CAUTION When used the pump contains human body fluids Dispose of the pump according to local regulations 2 Replace the pump seals only as needed Remove the old pump seals with a pair of hemostats or tweezers Fig 6 13 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 3 Press the new pump seals into the seal recess with the large side facing up Fig 6 13 Pump Seals 4 Install the new pump cartridge by first rotating the flat surfa
118. e 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 1s 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 R 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 SO H 100 7 Q 1 6 Adult leQ 2 9 18P0 1 661 10 2 4 172 lgPO IgPO 0 48 pH 7 4 IS 0 0013 BE Ee Fetal leQ 2 9 1g PO 1 3632 10570 4 113 lgPO lgPO 0 48 pH 7 4 BG 0 0013 BE P 21 5 5 Zander R Die korrekte Bestimmung des Base Excess BE mmol l im Blut Anesthesiol Intensivmed Notfallmed Schmerzther A 10 Operator s Manual OPTI R Analyzer ctO P50 APPENDIX A TECHNICAL SPECIFICATIONS 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
119. e having a PCO 40 mmHg __ q4 st pH 6 022 st HCO 10 p mmol L 6 Total concentration of CO in plasma the sum of dissolved CO and bicarbonate tCO HCO 0 0307 PCO mmol L The base excess of the blood results from a calculation to determine the titratable base of the blood which in principle is measured by titration of the blood with a strong acid or base to a pH of 7 4 with PCO 40 mmHg at 37 C BE 1 0 014 tHb 1 434Hb 7 7 pH 74 248HCO Jett The base excess of extracellular fluid is a quantity that reflects only the non respiratory components of acid base balance tHb 5 g dL DE 16 2 pH 7 4 24 8 HCO mmol L 7 7 NCCLS Blood Gas and pH Analysis and Related Measurements Approved Guideline NCCLS document C46 A 2001 Operator s Manual OPTI R Analyzer A 9 APPENDIX A TECHNICAL SPECIFICATIONS BE act Base excess at actual oxygen saturation BE ger 1 0 0143 tHb 1 63 tHb 9 5 pH 7 4 24 26 HCO SO 0 2 tHb 1 100 mmol L BB The buffer base is the concentration of buffering anions which is available in whole blood to buffer strong acids and consists mainly of protein anions and bicarbonate Of the protein anions hemoglobin is the most significant BB BE 41 7 0 42 tHb mmol L SO c The oxygen hemoglobin dissociation curve theoretically allows that oxygen saturation of available hemoglobin can be calculated provided the form of th
120. e 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 is 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 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 R Operator s Manual I Guilbault GG Ed Practical Fluorescence 2nd Ed Marcel Dekker 1990 Operator s Manual OPTI R Analyzer 8 1 8 OPERATING PRINCIPLES 8 3 Operation The OPTI R is a microprocessor based instrument measuring optical fluorescence A cassette contains the sensors storage buffer and a valve to control fluid flow After reading the calibration information spec
121. e 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 Na change mmol L Sodium fluorescein 25 mg dL unstable Cardio indocyanine green 0 5 mg dL 15 Methylene blue 25 mg dL unstable Only clear uncolored quality control materials such as OPTI CHECK brand aqueous controls should be used with the OPTI R system Colored materials including proficiency testing materials may interfere with the ion measurement or fail to be properly aspirated Na 2 Operator s Manual OPTI R Analyzer ANALYTES SODIUM Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI R instruments Sodium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level 1 127 1 0 42 0 3 1 09 0 9 1 31 1 0 Level 2 146 3 0 46 0 3 1 31 0 9 1 44 1 0 Level 3 160 2 0 28 0 2 1 39 0 9 1 51 0 9 Serum 141 0 0 53 0 4 1 15 0 8 1 43 1 0 Reduced Bovine Hemoglobin 141 7 0 51 0 4 1 78 1 3 2 16 1 5 Solution All specific performance characterist
122. eady A 1040 12 Nov ores Pask The Fluid Pack has either reached the shelf life Gas Not Ready expiry date or the 4 weeks in use expiry um Pied Fluid Pack e Remove the expired fluid pack and follow the prompts to install the new fluid pack see Section 6 5 2 Baro 732 4 New Fluid Pack Data QC System Manager Manager Manager 12 Nov 10 13 Expired Fluid Pack Operator s Manual OPTI R Analyzer 7 11 7 DIAGNOSTICS AND TROUBLESHOOTING 7 12 NotReady A 1040 12Nov D ra A 8396 Gas Not Ready 596 Low Gas New Gas Bottle QC System re Manager Manager Baro 732 4 NotReady 10 40 12 Nov Samples 0 Pack 83 a Not Ready Expired Gas 7324 New Gas Bottle Data QC System Manager Manager Manager Not Ready A 10 40 12 Nov LI ma A Gas Not Ready 50 Gas Rejected 732 4 New Gas Bottle QC System one Manager Manager NotReady 10 40 12 Nov 4 nes A Gas Not Ready em No Cassette 732 4 Install Cassette Data QC System Manager Manager Manager e 12 Nov 10 13 No cassette J The gas pressure is low e Replace the gas bottle see Section 6 5 3 The in use 9 months or labeled shelf life of the gas bottle has expired e Replace the gas bottle see Section 6 5 3 The gas bottle is rejected if the gas concentration is outside the specifications e Replace the gas bot
123. ecking the ln 7 22 1 2 12 Checking RS EE 7 23 GE EE 1 24 1 2 14 ENE 7 25 FA 19 ETE EN eee 7 25 7 2 16 Checking the Touch Gcreen 7 26 7 2 17 Checking the RS232 Interface 7 27 7 2 18 Checking the Ethernet Intertace ccc ccccccceceeeeceeeceeeeceeceeeeseeessueessueeseeessueesaeeseas 7 28 T2510 TETEN Ge maaedeen 7 29 1 2 20 Printing o EEE EEE NE 7 30 Vial ZW DETTE en m 7 31 2 Patient Diagnostic E e EE 7 31 EA Auto QC Diagnostic Report EEE EN 7 32 o A E ENER T m 7 33 7 2 21 4 Calibration Diagnostic Report 1 34 2 EVOM LOO TM 7 35 1 2 21 6 Configuration ic ee E 7 36 ro TTOUDIESNOOUNG 7 37 FN Fluidics Troubleshooting Mmmm 1 37 rac RNA 7 39 3 3 FT NN 7 40 foe Troubleshooung Procedure tor tHD SO Jemen 7 41 7 4 Troubleshooting Procedure for Bar Code Scanner 7 42 Operator s Manual OPTI R Analyzer T i 7 DIAGNOSTICS AND TROUBLESHOOTING 7 DIAGNOSTICS AND TROUBLESHOOTING Your OPTI R 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 R specific error messages and recommends steps that should return your OPTI R to operation If your OPTI R does not perform correctly after conducting the basic steps outlined in this chapter you should contact OPTI Medical Systems for technical assistance 7 1 E
124. ed if controls have not been run within the specified time e Press OK land run control materials The temperature is out of range during any kind of measurement e Press OK land continue e Ifthe error message appears again check the temperature under System Diagnostics Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING Not Ready A 10 40 12 Nov H This prompt indicates that no fluid pack is present Pack eni 0 or that the fluid pack is invalid A fluid pack is only x Not Ready valid 1f it passes all the installation checks No Fluid Pack l l 7324 e Follow the prompts to install a new fluid pack see Section 6 5 2 New Fluid Pack Data QC System Manager Manager Manager 12 Nov 10 13 No fluid pack NotReady A 10 40 12 Nov Samples The Fluid Pack has a fill level of 0 in one or more a A fluid pouches Gas Not Ready e Press New Pack to install a new Fluid Pack ae LOW Fluid Pack see Section 6 5 2 New Fluid Pack Data QC System Manager Manager Manager 12 Nov 10 13 Low Fluid Pack hs d NotReady A 1040 12 Nov Pack During the pack installation the wash buffer or one Not Ready of the QC levels was outside the installation limits Fluid Pack Rejected I Baro wen e Install a new Fluid Pack see Section 6 5 2 732 4 New Fluid Pack Le Q Data C System Manager Manager Manager NotR
125. een indicating that the cover should not be opened Upon completion of the measurement the results are displayed Fig 4 30 e The OPTI R 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 10 Press 3 Up to go to the next screen which gives you the option to accept or reject the results e Press Accept if results are acceptable Fig 4 31 and the results will be stored in the Control Database e Select lt Reject gt to reject the results Rejected results will not be stored in the Control Database e Select Review to view the results again NOTE 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 NOTE If any of the results are outside of the OPTI R 5 measurement range giving a LOW or HIGH the results cannot be accepted to the controls database e If other levels of controls are to be run repeat the procedure Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 5 3 Printing QC Reports 4 5 3 1 Printing Auto QC Reports Your OPTI R can print reports containing Ready 10 40 12 Nov information on the mean Standard Deviation SD Measurements Diagnostics Control Install Slope Data Calibration Patient Print Mi
126. eparin 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 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 values higher than normal are expected Operator s Manual OPTI R Analyzer 5 1 5 SAMPLE HANDLING AND PATIENT TESTING 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
127. er 15 Close the SMC cover by pressing it down firmly Fig 6 23 Cancel Fig 6 23 Close Cover eech SS LS The system will now check the integrity of the cassette and then calibrate Fig 6 24 For more information about calibration please refer Cassette Calibration In Progress to Chapter 4 Calibration and Quality Control Please Wait WARNING Do not remove the sensor cassette ise until the applicable number of patient samples or expiration date has been reached Removal of the cassette without being prompted to do so will result in premature expiration of the sensor cassette currently installed in the analyzer Measurement Ready Lg Samples 50 Start Sampl MEME Mein ivit Once the calibration is complete the Ready display appears identifying the number of samples available on the new cassette Fig 6 25 Pack 83 Gas 50 Baro 732 4 Next Event 05 18 Run Sample Data QC System Manager Manager Manager Fig 6 25 Ready Display Operator s Manual OPTI R Analyzer 6 9 6 MAINTENANCE 6 5 2 Changing the Fluid Pack NotReady A 1040 12Nov Samples A Not Ready Expired Fluid Pack Pack DS Gas 50 Bara 732 4 New Fluid Pack Data QC Manager Manager i 12 Nov 10 13 Expired Fluid Pack i Fig 6 26 Select New Fluid Pack System Manager System gt Utilitles Not Ready 10 40 12 Nov Installation Utilities
128. er Calibration Run gt from the lt System Manager gt Utilities gt menu Fig 4 41 After completing the calibration successfully the analyzer will return to the lt Ready gt display Operator s Manual OPTI R Analyzer 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling eese 5 1 FE UY c 5 1 5 1 2 TERESA 5 1 5 1 3 Anticoagulants and Sample Collection Devices 0nnonnonnennonnennsrrsrrsrrerrerrsrrerrsrrerrn 5 1 SM STN E M 5 1 cum NNN 5 2 5 1 6 OPTI Medical CGomiortGampler 5 2 5 1 7 Handling and Storage of Samples 5 2 SNEMEI Renee Tm 5 4 o2 Sample Preparati Un NEE 5 4 5 2 1 Whole Blood SamplGS i eseseeer rtt nba raa bri gata federa b abili gnata ace ug eene t afr art 5 4 5 3 Running A Patient Sample re 5 5 5 4 Printing Patient Reports raxrnnrnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnnnnnnnnnnnunnnnnnennunnunnne 5 11 Operator s Manual OPTI R Analyzer 5 i 5 SAMPLE HANDLING AND PATIENT TESTING 5 SAMPLE HANDLING AND PATIENT TESTING The OPTI R Analyzer provides fast and convenient measurement of pH PCO PO Na K Ca tHb and SO in whole blood and pH Na K and Ca in serum and plasma The analyzer will accept specimens directly from most syringes capillary tub
129. er and the pack level is greater than 10 e Press OK land go to System Manager gt Utilities gt to perform a Master Calibration During a Master calibration the calibration gas was not detected e Check the gas bottle level and replace if below 20 e Perform fluidics trouble shooting procedure See Section 7 3 1 The fluid pack level is less than 10 e tis recommended to replace the fluid pack at this time The gas bottle level is less than 10 e tis recommended to replace the gas bottle at this time Once the number of available samples reaches 2 this warning is displayed e Make sure you have new cassettes on hand e Leave cassette in place to run the 2 samples left e Replace cassette now if it is inconvenient to replace the cassette after 2 samples it will take approx 25 minutes of calibration time after installing a new cassette If Patient ID Operator ID and or Accession Number is required and no patient data was input or patient data was previously edited without adding the required information this warning will be displayed e Press OK to continue and edit the patient data 7 3 7 DIAGNOSTICS AND TROUBLESHOOTING ERROR No Patient ID Entry OK ERROR Bad Sensors Discard Cassette OK ERROR Possible Clot K ERROR Gas Expired K E ERROR Cassette Misseat 1 Re insert Cassette OK Cancel 7 4 If Patient ID O
130. error message appears again check the date in lt System gt Time and Date gt e Verify the product expiration date 1 7 7 DIAGNOSTICS AND TROUBLESHOOTING ERROR Invalid Barcode Different QC Lot m ERROR Invalid Calibrator OK ERROR Invalid QC Lot SC ERROR Need Setup QC OK ERROR Op ID already Exists x ERROR Invalid PIN x 7 8 The bar code was invalid e Verify that lt Scan A gt and lt Scan B gt of the QC material is from the same level and lot number e Press OK to continue The cassette placed in the SMC is invalid e Verify that the cassette placed in the SMC is a valid calibrator cassette e Press OK to continue The QC lot is invalid e Press OK to continue e Configure the control material under QC Setup and retry A measurement of QC materials was attempted prior to setting up e Press OK m continue e Configure the new QC material under QC Setup and retry The Operator ID already exists in the database e Press OK m continue e Enter a unique Operator ID The PIN number does not exist in current Secure Op ID database e Press OK Ito continue e Retry with a valid PIN number Operator s Manual OPTI R Analyzer ERROR PIN already Exists CAN ERROR No Response Retry Yes No ERROR Host not Ready Retry ERROR Calibration Out of Range x STOP Low Gas Re
131. es Each QC level of control has its own unique lot number printed on the information sheet contained in the control box CAUTION Do not use a control material that contains dyes fluoro carbons or silicones as these constituents will affect the results reported From the previous bar code scans confirm lot number expiration date and control type on the package insert supplied with the control material Fig 4 11 If the bar code is unavailable press lt Manual gt on the lt Scan Barcode gt screen and enter the control information manually S Press f l Save to accept 4 7 4 CALIBRATION AND QUALITY CONTROL 4 8 Setup QC Print Old QC Data w Setup QC m mM Delete Old QC Data PCOZ em ed PO2 ded ed Nat em g K ed den Ca edt ed cancel pl Save Q Up Home Fig 4 12 Confirm Assay Ranges 1 QC gt Setup Control Not Ready 104 12 Mov Ranges Ranges 2 Low ned tHb gea T Gro 802 4 Edit 4 Edit Level cancel pl Save Q Up eire Fig 4 13 Confirm Assay Ranges 2 Press Yes to obtain a printout of the old database Press Yes to delete the old database e fno previous QC data exists in the database the print and delete display screens will be bypassed s Ifyou do not want to change the current lot information but want to verify current programmed QC ranges press NO for
132. es and the OPTI Medical ComfortSampler through the fillport on the OPTI R 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 1 2 Sample Requirements Refer to NCCLS 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 h
133. eseure A 1 CST EN e ASE EAEN A 1 Bel Ile in Reie A 1 PENNEN A 2 TOUT EEE ERE A 2 Temperature Corrected Values A 4 Reference HIS 110 EEE EEE NE EE A 5 BEE Ge La en EE EEE A 6 RS2Z32C Pin Configuration 00 ccc cssectsnnedecncecessversesessenenecsdsedseseacsencnaedeareteesntecnceansteanssasenseeensies A 6 Mains Supply for External Power Supply cccccsesccusecusecurecssecesecssnaesnussnerseesseussasscussourecars A 6 NENNE A 6 DIMENSIONS And VVC E A 7 Ge le EEE u m A 7 Calcul ted ME un EE A 7 EET NG A 7 Units Used in Measured and Input Parameters for Calculatons s A 8 Conversion Table for Une A 8 APPENDIX B MENU STRUCTURE sunnnnnrnnennvnnnnnnnnnnnennnnnnnnennnnnnnnnnnenn B 1 APPENDIX C MAINTENANCE LOG eere nnn C 1 APPENDIX D REPORT FORMATS esuonrnnrnnennnnnennvnnnnnennnnnennennnnnnnnnnnnenn D 1 Basic Patient Report senior D 1 Auto QC Measurement IebDOL L uci tantus X drach e mE db dnd bonae n acumine dia D 2 Auto QC SENSE 0 6 EEE EEE D 3 AQC Install Slope Measurement Report r rrnrnranennnrnnanernnrennnrnranennnennnnennnrnnnnennnnennnennusernsrnnunennn D 4 Controls Measurement Report rrarrrannnnnnnnnnnanennnenanenunnnnnnnannnennnernnnsnnnennnennnennnennnennnennnennnennnsnnee D 5 CONTO Care re LC ecm Re D 6 Patient Measurement Calibration Report arrranrranenanenanennnennnernnenanennnnnnsnnnennanenunnnennnennneenneennee D 7
134. ess Next repeatedly to access the lt Tests gt screen Page 5 of 5 e Press Flow Test gt to start the test Fig 7 32 e Leave the current cassette in place or insert either a new cassette or the shut down cassette Fig 7 33 NOTE This test can be performed at any time and will not invalidate a cassette e Close the SMC cover e Wait for test results Fig 7 34 e The test result indicates if buffer or air was detected at the front and ion light gate For the test to PASS both light gates need to detect buffer Fig 7 35 e Ifeither one or both light gates detect air the test fails Fig 7 36 e Repeat test If the test continues to fail test the fluidics as outlined in Chapter 7 3 1 Operator s Manual OPTI R Analyzer 7 29 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 20 Printing Error Report System gt Diagnostics Not Ready This menu gives you the option to print out the last 12 No 100 error occurrences Tests Page 5of 5 em Printer SC From the lt Ready gt display press lt System Manager gt lt Diagnostics gt pee iii id In the Diagnostics Sensors screen press E Next repeatedly to access the lt Tests gt screen Touch R5232 Ethemet Page 5 of 5 Print Emor pg EE e Press Print Error Report gt Fig 7 37 to rint out the error report Back Next P P 3 ve Ga Home Fig 7 37 Print Error Report 7 30 Operator s Manual OPTI R Anal
135. eters A 2 Operating principles 8 1 Operation analyzer 8 2 Operator ID 3 3 5 6 secure setting up 3 13 Optics test 7 22 Overvoltage category A 6 Oxygen content 8 9 calculation A 11 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 reference intervals PO2 1 references PO2 3 reproducibility PO2 2 temperature corrected A 12 P P50 8 9 calculation A 11 reference ranges A 5 Parameters Operator s Manual OPTI R Analyzer blanking 3 5 measurement ranges l 1 A 1 reporting units 1 1 Password setting up 3 11 Patient data enter 5 5 information customizing 3 3 report printing 5 10 testing 5 1 Patient analysis performing 9 2 Patient ID 3 3 5 6 Patient sample data sheet 9 3 Peristaltic pump cartridge description 1 5 replacing 6 5 pH pH 1 clinical significance pH 1 correlation to other methods pH 3 interferences pH 2 linearity pH 3 measurement principle pH 1 measurement range pH 1 reference intervals pH 2 references pH 3 reproducibility pH 2 temperature corrected A 12 Pollution degree A 1 Potassium K K 1 clinical significance K 1 correlation to other methods K 4 interferences K 2 linearity K 3 measurement principle K 1 measurement range K 1 reference intervals K 2 references K 4 reproducibility K 3 Power connector description 1 6 Powerdown proce
136. f fluid pack and gas canister If a new sensor cassette has not yet been installed into the OPTI R analyzer please follow the instructions with the guidance of your representative The OPTI R Analyzer will now begin calibration of the sensor cassette and will display lt Ready gt when this activity has been completed approximately 20 minutes The Ready display will then inform you that installation was successful and 2 levels of OPTI Check must be run Press Continue and follow the instructions that appear on your display as described in the Operator s Manual NOTE The OPTI Check controls must be set up prior to using this feature or running controls Refer to Chapter 4 of the Operator s Manual for further instructions Run Quality Control Testing in accordance with the reference manufacturer s recommendations Verify that all QC testing results are well within the recommended limit level ranges Customize all OPTI R patient and sample information entries to match those of your reference instrument as required by your testing facility Chapter 3 of the OPTI R Operator s Manual 9 2 Aqueous Quality Control Testing Chapter 4 of the OPTI R Operator s Manual explains the process of setting up and running Auto QC as well as external controls if deemed necessary by your facility Please refer closely to this section in order to set up automatic testing according to your facility s preferences Operator s Manual OPTI
137. g 2 6 Gas test 7 23 H Hematocrit 8 9 calculation A 13 reference ranges A 5 Hemoglobin oxygen saturation 8 9 A 10 calculation A 10 reference ranges A 5 Hemoglobin oxygen saturation SO2 THB SO2 1 clinical significance THB SO2 1 correlation to other methods THB SO2 4 interferences THB SO2 3 linearity THB SO2 4 measurement principle THB SO2 2 measurement range THB SO2 2 reference intervals THB SO2 2 references THB SO2 4 reproducibility THB SO2 3 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 Instrument setup and preparation 9 1 Interface Ethernet test 7 27 RS232 test 7 26 Interferences 8 12 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 Language selecting 3 18 LEDs checking 7 16 Limitations 8 11 Linearity and Correlations 9 1 M Mains supply A 6 Maintenance 6 1 as needed 6 7 daily 6 1 log C 1 quarterly 6 1 seminannual 6 5 weekly 6 1 Manuals 10 2 Master calibration 4 18 6 17 Menu structure B 1 Model and serial numbers 1 6 N Normalized ionized calcium reference ranges A 5 Normal ranges setting 3 7 O Operating altitude A 1 Operating param
138. ge red cell Default value of MCHC 33 3 input range 29 0 to 37 0 nCa The ionized calcium value normalized to pH 7 40 For blood nCa pH 7 4 Ca 10 022 0H74 mmol L For plasma or serum nCa pH 7 4 Ca 10 0240H74 mmol L 10 Simmons A ed Hematology A Combined Theoretical amp Technical Approach pp 28 29 Philadelphia W B Saunders 1989 Operator s Manual OPTI R Analyzer A 13 APPENDIX B MENU STRUCTURE APPENDIX B MENU STRUCTURE e abenbue uode 10 114 9JeMpJeH 1S9 MOI J8 uld jeuiaum3 undas ZETSU SHUN yono uwopinus uone e J0 e dsiq UMOpJ MOd sabuey dung 9JnsseJgd 607 juaa3 ieee ered EWWON 159 seg 9 9 SBS oujeuloJeg UOHEIQIED UOHEIGIIED spog seo EN Weed je sondo EIER 1984 Spa OD sq31 0100 SJONUOS 9jlesse ARREN UeJeg Spa JOU SAU AMEN S9 9A EA 9jesse duie 90 ONY 20 ONY yoed p n 4 ga C Anua juaned gd opooJeg 9jesse ue 9 9 YOed SUOISJ A ueneg Used d KR J s s L SAM 041002 E SJOSUSS uoneun amp ijuo spodey sonenejs spoday dale 9N9SSEN s jqewnsuo onsouDeiq jueulaJnseeJy I1 I I T pr UOIje
139. hotons are partially absorbed and reflected by erythrocytes in a manner proportional to hemoglobin level at low hemoglobin levels the unabsorbed photons strike the O optode s pink overcoat and are reflected back up through the blood a second time A portion of the reflected light exits the top of the cassette and 1s 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 Reference Intervals Oxygen Saturation Sample type Range Whole blood arterial Newborn 40 90 thereafter 94 98 Total hemoglobin Sample type Range g dL Whole blood Adult male 13 9 16 3 Adult female 12 0 15 0 THB SO2 2 Operator s Manual OPTI R Analyzer ANALYTES tHb SO Interferences The following interferents were quantified in whole blood showing sensitivity to dyes
140. ibration System gt Utilities Not Ready 10 40 12 Nov Installation Utilities Calibrator Run Master Calibration acm Re eG S Power Control Powerdown ShutDown Up Home Fig 6 44 Select Run Calibration Running Master Calibration Fig 6 45 Master Calibration Operator s Manual OPTI R Analyzer 6 MAINTENANCE The analyzer will perform a calibration verification every 30 minutes You may however perform a master calibration at any time by selecting lt Master Calibration gt Run gt from the lt System Manager gt Utilities gt menu Fig 6 44 After completing the calibration successfully the analyzer will return to the lt Ready gt display 6 MAINTENANCE 6 6 3 Taking out of Operation 6 6 3 1 Powerdown Procedure System gt Utilities Not Ready 10 40 12 Nov Installation Utilities Calibrator Run Master Calibration Power Control Q ve Home Fig 6 46 Select Powerdown Are You Sure You Want to Powerdown Yes No Fig 6 47 Confirm Powerdown Please Wait Fig 6 48 Powering down Please tum off instrument Fig 6 49 Turn off instrument 6 18 For extended periods of inactivity of up to 72 hours the system can be powered down e Select lt System Manager gt Utilities from the lt Ready gt menu e Inthe lt Utilities gt menu select lt Powerdown gt to start this procedure Fig 6 46 e Inthe following display Fig 6
141. icro 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 OPTI CHECK provides a method of performing daily QC checks for laboratories selecting to measure liquid QC material 8 5 7 Reference Intervals Reference intervals are useful in describing typical results found in a defined population of apparently healthy people Reference intervals should not however be used as absolute indicators of health and disease due to variability among methods laboratories locations and other considerations Individual laboratories should generate their own set of reference intervals Guidelines for defining and determining reference intervals are published in the 2000 NCCLS C28 A2 guideline How to Define and Determine Reference Intervals in the Clinical Laboratory Approved Guideline Second Edition The analyzer is preset to adult reference intervals derived from Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4th Ed Elsevier Saunders 2006 pps 2252 2302 The preset intervals and procedures for adjusting the intervals to those derived for the individual laboratory are described in section 3 3 2 1 of this manual 8 5 8 Specific Performance Characteristics All performance
142. ics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI R 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 LS T Standard Reference Material 956a Electrolytes in Human Serum Sodium sp Correlation Slope Intercept Coefficient Sy x Range n Sodium 1 0554 5 760 0 99979 0 75 93 179 30 Sodium 0 9898 2 611 0 99875 1 015 123 164 14 NIST Operator s Manual OPTI R Analyzer Na 3 SODIUM ANALYTES Correlation to Other Methods OPTI R 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 R 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 Coefficien
143. id Pack QC ranges this step must be done now See Chapter 4 for instructions Fig 2 12 New Component Check Operator s Manual OPTI R Analyzer 2 5 2 SETUP 2 6 Manual Cancel Fig 2 13 Scan Gas Bar Code Fig 2 14 Insert Gas Bottle New Gas Bottle 7 Installing a New Gas Bottle After installation of the OPTI R Fluid Pack you will be asked to install the gas bottle NOTE NOTE NOTE NOTE Open the gas bottle by unscrewing the cap Scan the new gas bottle bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer Fig 2 13 The bar code can be found on the gas bottle instructional insert The red line from the bar code scanner should cover the entire bar code The analyzer will beep when the bar code is accepted Record the date of installation on the gas bottle for later reference To enter the bar code manually press lt Manual gt and enter the bar code using the numeric keypad When prompted Fig 2 14 insert the gas bottle in its housing and turn clockwise until fingertight Press OK The gas bottle expires 9 months after installation or after exceeding the labeled expiration date whichever comes first The bar code contains expiration information The OPTI R will alert the operator two weeks prior to expiration of the gas bottle as a reminder to order a replacement gas bottle When thi
144. ies gt Calibrator Not Ready Insert Calibrator 9 Gently wipe both sides of the Calibrator Cassette with a clean dry cloth and examine it to ensure itis clean Insert it into the chamber and press down to properly seat the cassette Fig 6 8 Cancel Fig 6 8 Wipe and Insert Cassette Operator s Manual OPTI R Analyzer 6 3 6 MAINTENANCE Syste m gt Utilities gt Calibrator Not Ready 10 40 12 Nov Close Cover Cancel Fig 6 9 Close Cover syste m gt Utilities gt Calibrator Calibrator Measurement In Progress Please Wait Calibrating Fig 6 10 Calibration in Progress OPTI Medical OPTI R Calibrator Report DD MMM YY HH MM S N XXXX Version ABCX XX Operator ID HbCal LOT XXXXXX HbCal Date DD MMM YY Calibration Results Meas d Cal d tHb 12 9 13 0 S02 5 74 6 74 9 Calibration Factors OLD NEW F1 1 023 1 014 F2 1 087 1 080 F3 1 089 1 094 F4 0 000 0 000 Fig 6 11 Calibrator Report 6 4 10 Close the sample chamber cover Fig 6 9 After the cover has been closed the instrument will automatically detect the presence of the calibrator cassette and begin calibration Fig 6 10 11 After the calibration is complete you will be prompted to open the sample chamber cover and remove the cassette 12 Place the calibrator cassette back into the clip inside of the printer door immediately after removal from the instrument NOTE Make sure to keep th
145. ific to a cassette into the instrument by holding the cassette package in front of a convenient bar code scanner the cassette 1s 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 channel is calibrated with the wash buffer contained in the fluid pack which is tonometered with the gas from the gas bottle The electrolyte channels are calibrated using the wash buffer solution contained in the Fluid Pack The tHb and SO channels are factory calibrated When calibration is verified the analyzer is ready for sampling Up to 50 blood samples can be analyzed on one cassette At the start of an analysis 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 completion of the measurement the analyzer will wash the cassette and perform a gas calibration The Fluid Pack contains the wash solution and a waste pouch 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
146. ike 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 R using the measured pH Measurement Range Range Resolution Low High Units 100 to 180 1 0 1 mmol L Operator s Manual OPTI R Analyzer Na 1 SODIUM ANALYTES Reference Intervals gt Sample type Range mmol L Whole blood serum and plasma Premature 48 hr 128 148 Newborn 133 146 Infant 139 146 Child 138 145 Adult 136 145 gt 90 yr 132 146 Interferences The OPTI R Na sensor has no measurable interference from K variation within the range 0 8 10 mmol L The OPTI R Na sensor does exhibit a small interference from Li Li levels of 1 0 2 5 and 6 4 mmol L will cause a positive Na bias of 0 9 1 2 and 1 3 mmol L respectively A syringe sample anticoagulated with typical amounts of lithium heparin has 1 4 mmol L of lithium which offsets the measured Na by less than 1 To minimize the interference from lithium use syringes containing the lowest acceptable heparin level Carefully follow the syringe manufacturer s recommendation regarding proper filling of the syringe A partially filled syringe results in excessive lithium concentration The OPTI R 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 ar
147. imits Na 139 0 149 0 mmol L K 4 40 5 20 mmol L Date Nat K OK O4May 143 9 4 76 OK O4May 143 6 4 74 OK O5May 143 8 4 77 OK Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS HEMOGLOBIN LIMITS tHb 12 6 SOA 94 0 ADDITIONAL Ca 1 14 Date Cart 04May 1 24 04May 1 20 05May 1 22 d o oU LIMITS 1 35 mmol L OK OK APPENDIX D REPORT FORMATS AQC Install Slope Measurement Report OPTI Medical OPTI R AQC Install Slope Measurement DD MMM YY HH MM Level 2 Sample No 2345 PackLot 123456 Exp MMMYYYY RESULT LIMITS OK pH 7 551 7 48 7 56 OK PCO2 69 8 65 75 OK PO2 99 8 96 105 OK Nat 144 2 142 148 OK K 4 46 4 0 4 8 OK Cat 1 10 1 0 1 2 OK tHb 14 7 14 0 15 3 OK 502 98 3 96 99 OK Control Test Result PASS Barometer 744 5 mmHg Operator ID 12345678901 S N21234 Lot r12354596 Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS Controls Measurement Report OPTI Medical OPTI R Controls Measurement DD MMM YY HH MM Level 2 OPTI check Sample No 2345 QCLot 1234 Exp MMMYYYY RESULT LIMITS pH 7 551 7 48 7 56 OK PCO2 69 8 65 75 OK PO2 99 8 96 105 OK Nat 144 2 142 148 OK K 4 46 4 0 4 8 OK Ca 1 10 jdn OK tHb 14 7 14 0 15 3 OK 502 98 3 96 99 OK Control Test Result PASS Store to Database YES Barometer 744 5 mmHg Operator ID 12345678901 S Ne1234 hobsl234D56 Operator s Manual OPTI R Analyzer D 5 APPENDIX D REPORT FORMATS
148. ing units and analyzer measurement ranges for each parameter Sample Type Available Units Measurement Display Range Resolution Parameter Whole Default Default Units Lo Hi blood Lr mmHg g L 6 8 7 8 0 01 0 001 mmo g dL mmol L 5 25 0 1 mmol L mg dL 100 180 10 1 fm 1 sm mm Principles of Operation The OPTI R Analyzer is a microprocessor controlled medical instrument measuring optical fluorescence from discrete sensors called optical electrodes optodes A multi use cassette contains the sensors storage buffer and a valve to control fluid flow After reading the calibration information specific to a cassette into the instrument by holding the cassette package in front of a convenient bar code reader the cassette 1s 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 channel is calibrated with the wash buffer contained in the Fluid Pack which is tonometered with the gas from the gas bottle The electrolyte channels are calibrated using the wash buffer solution contained in the Fluid Pack The tHb and SO channels are factory calibrated When calibration is verified the analyzer is ready for sampling Up to 50 blood samples can be analyzed on one cassette At the start of an analysis the analyzer aspirates the blood s
149. inutes to verify the stability of the sensor cassette The next item in the calibration matrix 1s performed after each patient measurement After the measurement the cassette is washed and the calibration is verified with fresh buffer The final item in the calibration matrix is a master calibration that uses the buffer in the fluid pack combined with the precision gas bottle 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 temperature control fluidic control during calibration proper equilibrium behavior of the sensors during calibration and measurement automatic detection of bubbles and short sample detection and automatic detection of low gas dirty optics or worn pump conditions Calibration of the tHb channel and the measurement LEDs is required every 3 months This calibration is performed using the Calibration Cassette in a manner similar to other instruments that measure tHb and or hemoglobin derivatives optically The calibration verifies the measurement optics and electronics and corrects any potential drift For more information including detailed instructions see Section 6 3 Quarterly Maintenance in this manual Operator s Manual OPTI R Analyzer 4 1 4 CALIBRATION AND QUALITY CONTROL 4 2 4 3 4 2 QC Overview The intent of a Quali
150. ions If an lt AutoQC failure gt occurs and lt Suppressed gt is selected Fig 4 5 the patient results for the failing QC parameter will not be reported If lt Flagged gt is chosen the analyzer will print an error message on each printout for the failing QC parameter Press lt Enable gt to enable lt Rilibak gt mode This mode requires use of a Type 2 Fluid Pack and is only available in software version 3 04 and higher Once activated the OPTI R will calculate the Auto QC ranges for levels 2 and 3 and the square mean in conformance with Rilibak regulations Press this button before installing a new pack to activate In this mode Auto QC level 1 is not available Level 1 will be used as part of a slope check only Press lt Enable gt to enable the lt Stat Sample gt option to run a STAT sample during cassette or fluid pack installation This feature must be enabled prior to installation 4 5 4 CALIBRATION AND QUALITY CONTROL 4 6 10 40 Suppressed Flagged Ce AQC Failure Enable Activate Rilibak je Stat Sample B Print Auto QC Report P 3 Back Page of 5 Cie Eg cancel f Save Za Home Fig 4 6 Select Auto QC Options PO2 target adjustment high altitude 1 3 Level v P Target Offset PO2 25 0 mmHg eat Back Page 5 of 5 QgNext Q ve firme Fig 4 7 Adjust AutoQC Oxygen Target Data gt Auto QC Measurement gt Statistics 10 40 1
151. it and surface to prevent unit overheating Operator s Manual OPTI R Analyzer 2 1 2 SETUP 2 3 Setting up the OPTI R Analyzer 2 2 You are now ready to prepare your OPTI R Analyzer for operation Begin by placing the analyzer on a secure table top that allows plenty of working space and is convenient to a power connection 1 Plug in the Power Supply e Plug the power supply into the receptacle on the left side of the unit Fig 2 1 e Plug the power cord into the power supply e Plug the cord into a grounded electrical outlet NOTE To protect your OPTI R 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 Turn on the Power e Locate the power switch on the left side of the unit and switch to ON Fig 2 2 Fig 2 2 Power Switch OPTI Medical OPTIR Version 1 00 e This is the first screen that will appear after the power is turned on Fig 2 3 WARNING Calibrator Expired Run Calibrator before installing cassette OK fer gt OPTIMedical e Press OK Warming Up mm o ii Fig 2 3 Start up screen Operator s Manual OPTI R Analyzer Please Enter the Time Hour Minute Fig 2 4 Enter Time Please Enter the Date Month Day Year Apr Fig 2 5 Select Month Please Enter the Date Month Day Year Apr 30 2011 Te
152. ive 2002 96 EC which mandates the treatment recovery and recycling of electric and electronic equipment Symbol CE REF 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 R 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 NSL potassium K ionized calcium Ca total hemoglobin concentration tHb and hemoglobin oxygen saturation SO in the convenience of your own laboratory This manual will help guide you through setting up your analyzer and will help you start analyzing samples As you become familiar with the operation of the unit you should use the manual as a reference for day to day routines and as a guide for maintenance and troubleshooting How to use this manual If you have an analyzer that
153. le EEE 3j 2 3 EJ 1 Cancel OK Fig 2 6 Enter Date Operator s Manual OPTI R Analyzer 2 SETUP Setting the Time and Date e The system will now prompt you to enter the current time using the numeric keypad Fig 2 4 e Enter hour and minutes and press OK e You will then be asked to enter the month Fig 2 5 e Select the month from the keypad and press OK e Inthe next screen you may enter the current day Fig 2 6 e Press OK and enter the 4 digit year e After entering the current time and date press OK to save your settings 2 3 2 SETUP Fig 2 8 Paper Advance Button Fig 2 9 Calibrator Cassette 2 4 Installing the Printer Paper Place paper into the paper tray With the OPTI R switched on thread the paper into the feeder slot as shown in the diagram on the analyzer Fig 2 7 As soon as the printer detects the paper it will automatically feed the paper completely through the printer The paper advance button should only be used if paper is present To advance paper after the initial installation press the red paper advance button located on the left side of the printer Fig 2 8 NOTE The red paper advance button is only active when the printer detects paper in the printer Run the Calibrator Cassette Run the calibrator cassette Fig 2 9 on a new OPTI R before installation of the Fluid Pack and sensor cassette Refer to section 6 3 Quarter
154. led one of the installation checks pouch integrity check excessive bubbles in buffer or end point error e Replace the cassette see Section 6 5 1 The temperature is out of range e Wait for the analyzer to reach the correct temperature e Ifthe analyzer does not become Ready within a reasonable time check the temperature under System Manager gt Diagnostics 7 13 7 DIAGNOSTICS AND TROUBLESHOOTING 7 14 NotReady 10 40 12 Nov Samples D pa A 83 Gas Not Ready 50 Fluidics Failure Baro 732 4 Qc System Manager Manager Manager Not Ready 10 40 12 Nov Samples 3 Pack Not Ready Fluidics Failure AQC Level X 732 4 Rerun AQC Data QC System Manager Manager Manager e 12 Nov 10 13 Fluidics Failure AJ NotReady A 1040 12 Nov Samples D A 8396 Gas Not Ready Bad Wash 724 Remove Sample Data QC System sina deseos scenen med NotReady A 1040 12 Nov 8 Samples 0 A 8396 Gas Not Ready 50 System Error 732 4 Waste Detect Failure Data QC System Manager Manager Manager A Wash solutions and or AQC L2 could not be detected although fluid levels of all solutions are greater than 10 e Press Ov to go to lt System Manager gt Utilities gt to perform a lt Master Calibration gt Analyzer is unable to detect AQC L1 L2 or L3 e Press lt Rerun AQC gt to repeat AQ
155. line 2nd Edition CLSI document EP7 A2 CLSI Wayne PA 2005 8 14 Operator s Manual OPTI R Analyzer 9 LINEARITY AND CORRELATIONS 9 LINEARITY AND CORRELATIONS eere nene nnn 9 1 9 1 Instrument Setup and Preparation cesses eene ener 9 1 9 2 Aqueous Quality Control Testing 1eeeeee eee eere rne 9 1 9 3 Performing a Patient AnalysiS anrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnennnunnn 9 2 9 4 Recording and Evaluating the Data eese 9 2 Patient Sample Data Sheet Le 9 3 Operator s Manual OPTI R Analyzer 9 i 9 LINEARITY AND CORRELATIONS 9 LINEARITY AND CORRELATIONS 9 1 Instrument Setup and Preparation l Verify that the lt Time and Date gt settings under the OPTI R analyzer lt Setup gt options match those of the facility s reference instrument Section 2 1 of Operator s Manual Open the printer cover and load the thermal paper into the analyzer by pressing the red paper advance button Then run the calibrator cassette as shown in Section 6 3 of the Operator s Manual If no OPTI R Fluid Pack has been previously loaded into the analyzer the message on the display screen will be lt Not Ready No Fluid Pack gt Fig 2 10 of Operator s Manual Follow the step by step instructions in the operator s manual for correct installation o
156. lored quality control materials such as OPTI CHECK brand aqueous controls should be used with the OPTI R system Colored materials including proficiency testing materials may interfere with the pH measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from I run per day with 2 replicates per run for 20 days on each of two OPTI R instruments pH is expressed in pH units Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level I 7 188 0 002 0 005 0 006 Level 2 7 414 0 003 0 009 0 010 Level 3 7 579 0 010 0 014 0 018 Serum 1222 0 008 0 010 0 013 Reduced Bovine Hemoglobin 7 428 0 008 0 008 0 011 Solution pH 2 Operator s Manual OPTI R Analyzer ANALYTES pH All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Linearity Wherever possible linearity for the OPTI R measurement has been established against reference materials or methods Linearity for pH of whole blood is established by measurement of blood specime
157. lotting DO NOT use anticoagulants such as EDTA citrate oxalate etc Use only heparin salts as anticoagulants WARNING Sedimentation of red cells may occur rapidly in whole heparinized blood This may affect your tHb results Make sure your sample is free of trapped gas bubbles and completely mixed by rolling the syringe between the palms of your hands and inverting end over end for at least one minute just prior to sample introduction 5 4 Operator s Manual OPTI R Analyzer 5 3 Running A Patient Sample Whole Blood Serum and Plasma Measurement Ready Samples 80 Start Sample Pack Measurement BAS Gas 50 Baro 732 4 Next Event 05 16 Measure ment Fig 5 2 Mix and place sample Fig 5 3 Attach Capillary Sample Operator s Manual OPTI R Analyzer 5 SAMPLE HANDLING AND PATIENT TESTING The OPTI R Analyzer is fast and easy to operate Whenever Ready appears on the display the unit is ready for sample measurement In the Ready display press lt Run Sample to start the measurement Fig 5 1 The display will then prompt you to mix and place the sample Fig 5 2 Mix the syringe sample well by rolling it between the palms of your hands and inverting end over end When placing a syringe sample attach a new syringe adapter e Sedimentation of blood cells causes alteration of tHb values Therefore mix the sample well just prior to analysis Using a c
158. ls report select Diagnostics gt Controls gt in the lt Data gt screen Fig 7 44 In the lt Data Control Diagnostics gt screen Fig 7 45 select the desired measurement and press the View button to display the control results Fig 7 46 Use the up and Doan buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 45 To print groups of results highlight the first measurement to be printed press vec then select the last measurement to be printed All the measurements in between will be selected Press 3 to select all results Press GP to print your selection Press Q UP to return to the Data screen 7 33 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 21 4 Calibration Diagnostic Report Ready The Calibration Diagnostic Report is Measurements Diagnostics available with the results after each measurement detailing the measured signal in millivolts and drifts Patient Control l e To print a calibration diagnostics report select lt Diagnostics gt Calibration gt in the lt Data gt screen Fig 7 47 Install Slope Data Auto QC Calibration Event Log Up Fy Home Fig 7 47 Select Calibration e Inthe lt Data Calibration Diagnostics gt screen Fig 7 48 select the desired calibration Data gt Calibration Diagnostics 12 Nov and press the View
159. ly Maintenance for instructions Operator s Manual OPTI R Analyzer 2 SETUP NotReady A 1040 12Nov 6 Installing a New Fluid Pack Enes TET Begin installation with the OPTI R Fluid Pack 09 Gas Not Ready 50 P lt N FI Pack gt Fie 2 10 No Fluid Pack di NERE EE 7324 NOTE Gloves should be worn when handling the Fluid Pack New Fluid Pack re Data QC System Manager Manager Manager 12 Mov 10 13 Mo fluid pack Fig 2 10 Select New Fluid Pack Not Ready 10 40 12 Nov e Record the installation date on the label of Insert Fluid Pack the pack e Remove the protective strip and insert the new OPTI R Fluid Pack in the compartment on the rear of the analyzer Fig 2 11 e Insert the guide on the left side of the pack into the slot of the pack receptacle e Rotate the fluid pack until it snaps into place to complete the installation Cancel Fig 2 11 Insert OPTI R Fluid Pack New Component Checks e As soon as the Fluid Pack is inserted the system will detect the presence of the Fluid Pack and retrieve the pack information from the integrated transponder All of the information will be stored in the AQG Level 3 analyzer s database AQC Level 2 E Completed Conditioning Toy Master Cal The system will then perform an integrity AQG Level 1 check of the Fluid Pack Fig 2 12 Master Gal e Ifyou wish to change the Flu
160. lyzer and the OPTI R Analyzer Run the number of predetermined patient sample comparisons in accordance with your evaluation protocol 9 4 Recording and Evaluating the Data 1 Please use the enclosed data sheets for all records 2 Results should be reviewed and approved by signature by the Laboratory Director or Medical Director overseeing laboratory testing in your facility Helpful Hints Verify that the OPTI R Analyzer wash calibration process 1s completed and that the OPTI R Ready screen is displayed This ensures that the time between analysis of the sample performed by the reference device and the OPTI R Analyzer is minimal 9 2 Operator s Manual OPTI R Analyzer 9 LINEARITY AND CORRELATIONS Patient Sample Data Sheet Ref Instrument x and S N OPTI y S N Evaluator Operator s Manual OPTI R Analyzer 9 3 9 LINEARITY AND CORRELATIONS OPTI TS or OPTI R ANALYZER circle Data Reviewed By Title Department Operator s Manual OPTI R Analyzer 9 4 10 SUPPLIES IECH e AT EE 10 1 10t ANAZO EM MN 10 1 12 e SEUES aE EE EEE 10 1 10 3 Controls Calibrators axrnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnennnnnnnnnnnnnnnnennnnnnnun 10 1 10 4 Consumable ltems rnnnnnnnnnnnennnnnnnnvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnennnennnennnune 10 2 109 ACCOSSOFCS eRT ER 10 2 TOG MG t 10 2 10 7 Spare e Sn 1
161. moglobin is the main component of erythrocytes It serves as the vehicle for transportation of oxygen within the bloodstream and each gram of hemoglobin can carry 1 39 mL of oxygen The oxygen combining capacity of the blood is directly proportional to the hemoglobin concentration rather than to the number of red blood cells RBC because some red cells contain more hemoglobin than others Although oxygen transport is the main function of hemoglobin it also serves as an important buffer in the extracellular fluid Decreases in the amount of hemoglobin can come about as a result of a decreased concentration of hemoglobin in the erythrocytes or a decreased number of erythrocytes that contain a normal concentration of hemoglobin Decreased levels are found in anemia states hyperthyroidism severe hemorrhage and hemolytic reactions due to transfusions of incompatible blood reaction to chemical infectious and physical agents as well as various systemic diseases Increased levels are found in hemoconcentration of the blood chronic obstructive pulmonary disease and congestive heart failure ctHb gives valuable information in an emergency situation if interpreted not in an isolated fashion but in conjunction with other pertinent laboratory data ctHb is used to screen for disease associated with anemia to determine the severity of anemia to follow the response to treatment for anemia and to evaluate polycythemia Hemoglobin Oxygen Saturati
162. n Comparative Method Slope Intercept Coefficient Sy x Range n Chiron 865 whole blood ctHb 0 9886 0 067 0 9737 0 56 3 16 1 93 S02 0 8350 16 19 0 9772 1 11 59 100 90 Roche OMNI whole blood ctHb 0 9365 0 27 0 9691 0 45 7 3 15 9 314 SO296 0 9115 7 07 0 9759 1 97 33 99 8 314 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 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 5 Kaplan LA Pesce AJ Clinical Chemistry Theory Analysis Correlation 3 Ed Mosby Year Book 1996 p 729 6 NCCLS Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Approved Standard 3 Edition NCCLS document H15 A3 NCCLS Wayne PA 2000 7 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b THB SO2 4 Operator s Manual OPTI R Analyzer APPENDICES APPENDIX A TECHNICAL SPECIFICATIONS A 1 Measurement RAGE EE A 1 Barometric Hr
163. n Factors Normal Cassettes Slope Offset pH 1 000 PCO2 1 0 PO2 Na Operator s Manual OPTI R Analyzer D 11 APPENDIX D REPORT FORMATS Error Report OPTI Medical OPTI R ERROR Report DD MMM YY HH MM S N XXXX Version ABCX XX DDMMMYY HH MM ERROR Cassette Misseat 1 DDMMMY Y HH MM ERROR Cassette Misseat 2 DDMMMY Y HH MM ERROR Gas Expired DDMMMY Y HH MM Warning Bubble Detected DDMMMY Y HH MM otop Low Gas D 12 Operator s Manual OPTI R Analyzer Optics Test Report OPTI R Optics Test DD MMM YY 13 25 S N XXXX pH PCO2 PO2 441 1014 1 40 0 30 0 35 0 14 027 Wale 158 84 K CIS 577 965 L9 0 55 41 0 22 40 220 36 104 tHb7 tHb8 644 605 2990 1886 Be Ore Operator s Manual OPTI R Analyzer APPENDIX D REPORT FORMATS D 13 APPENDIX D REPORT FORMATS Operator ID Report OPTI Medical OPTI R secure Op IDs DD MMM YY HH MM S N XXXK Number Used 0 Number Available 300 D 14 Operator s Manual OPTI R Analyzer INDEX A Accession No 3 3 5 6 Accessories 8 13 10 2 Alarm limits setting 3 7 Alveolar arterial oxygen difference 8 9 calculation A 12 reference ranges A 5 temperature corrected A 13 Analytes measurement ranges 1 1 A 1 reporting units 1 1 Analyzer components 1 3 customization 3 1 intended use 8 1 maintenance 6 1 operation 8 2 setup 2 2 Anticoagulants accepted types 5 1 8 3 AQC failure 4 5 Aspiration patient sample 5 4 QC sample
164. ng a Language 3 18 Cum 10 40 12 Nov Customize Patient Information Measured Calculated Patient el Parameters Parameters Miscellaneous Nomal Ranges Correlation Units Alarm Limits Hardware Fig 3 36 Select Language System gt Setup gt Lanquage Not Ready 12 Nov alect Language Portuguese ies Frangais C Espa ol C Italiano Lm Japanese C Chinese C Fig 3 37 Select Language This menu lets you choose the language you want the OPTI R to use for displays and printouts l From the Ready display select System Manager and Setup 2 Inthe System Setup menu press Language Fig 3 36 3 Select the desired language Fig 3 37 4 Press E to accept the changes 5 Press UP to return to the Setup screen or f Home to return to lt Ready gt Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 CALIBRATION AND QUALITY CONTROL eere 4 1 al CAM 2 4 1 4 2 OG ene 4 2 4 3 Proficiency ai KC dl Le E 4 2 24 Calibration Vee EN 4 3 45 QC Recommendations nutri ur seess gege OEVE UN MUN VUE ER KKEE NEN ENNEN 4 3 2 ox e 4 4 a eom SNU 4 4 4 5 1 2 Setting up the External Control Material Lot and Level 4 7 4 5 2 Performing QC Measurements 4 9 4 5 2 1 Running Auto QC Measurements E 4 9 4 5 2 2 Running an External QC Sample OPTI CHECK eese 4 11 4 5 3 Printing QC
165. ng 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 K is released from the blood cells thereby increasing the measured K In the same manner protein released from the cells binds ionized Ca and decreases the concentration While an accurate value is reported it will reflect the actual changes caused by hemolysis Lipemia equivalent to 3000 mg dL triglycerides Elevated white blood cell count 30 000 WBC uL The following substances were tested in plasma at the CLSI recommended test level or higher and showed no interference to blood gas and electrolyte analytes Coumadin Warfarin 12 mg dL Dicumarol Dicoumarin 11 mg dL Procain Novacaine 13 mg dL Acetaminophen Paracetamol 20 mg dL The OPTI R 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 gt Clinical and Laboratory Standards Institute CLSI Interference Testing in Clinical Chemistry Approved Guideline 2nd Edition CLSI document EP7 A2 CLSI Wayne PA 2005 8 12 Operator s Manual OPTI
166. nges 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 8 4 5 Capillary Tubes Capillary blood specimens should be collected using capillary tubes which have a minimum volume filled of 125 uL The OPTI Medical capillary tubes MC0024 are ideally suited with a minimum volume filled of 200 uL The capillary tubes for pH blood gas and electrolyte analysis should not be used for samples taken for the analysis of lithium Operator s Manual OPTI R Analyzer 8 3 8 OPERATING PRINCIPLES Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arteri
167. nostics gt screen Fig 7 42 select the desired measurement and press the Ve button to display the Auto QC results Fig 7 43 Use the up and Dom buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 7 42 To print groups of results highlight the first measurement to be printed press then select the last measurement to be printed All the measurements in between will be selected Press 9 to select all results Press Print Press Up to return to the Data screen to print your selection Press Install Slope Data Fig 7 41 to view data from pack installations and slope check Operator s Manual OPTI R Analyzer 7 2 21 3 Control Diagnostic Report Install 5lope Auto QC Data Calibration Event Log Up Fy Home Fig 7 44 Select Control Data gt Control Diagnostics 12 Nov Level Date VIKE temmes 1 12Juli2 10 19 Q3 vr Home Fig 7 45 Select Measurement Data Control Diagnostics View mV meter pH 375 9 PCO 424 0 PO2 476 3 Nat 102 8 K 431 1 kuak 59 vr fp Home Fig 7 46 Control Diagnostics Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The lt Control Diagnostic Report gt shows details of measured signals in millivolts as well as drifts observed during measurement To print a contro
168. ns which were tonometered to various CO values and measured on an AVL 995 pH Blood Gas Analyzer standardized to N I S T traceable pH buffers and on three OPTI R systems Correlation Slope Intercept Coefficient Sy x Range n 0 9724 0 219 0 99714 0 013 7 17 7 55 29 Correlation to Other Methods OPTI R 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 R 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 Chiron whole blood 0 9806 0 139 0 9723 0 016 7 13 7 59 95 Roche OMNI whole blood 1 0416 0 304 0 9961 0 011 6 8 7 53 314 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 A Fiber Optic pH Probe for Physiological Use Anal Chem 53 p 864 1980 3 Wolfbeis OS Offenbacher H Fluorescence Sensor for Monitoring Ionic Strength and Physiological pH Values Sensors and Actuators 9 p 85 1986 4 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006
169. nst reference materials or methods Potassium linearity is established by measurement of gravimetrically prepared N I S T traceable aqueous standard solutions Potassium and by measurement of N LS T Standard Reference Material 956a Electrolytes in Human Serum Potassium Correlation Slope Intercept Coefficient Sy x Range n Potassium 0 9725 0 108 0 99996 0 03 0 6 8 5 30 Potassium 1 0416 0 023 0 99990 0 030 2 0 6 0 14 NIST Operator s Manual OPTI R Analyzer K 3 POTASSIUM ANALYTES Correlation to Other Methods OPTI R 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 R 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 Chiron whole blood 0 9614 0 025 0 9922 0 074 2 9 5 7 97 Roche OMNI whole blood 0 9764 0 04 0 9839 0 12 2 8 9 4 314 AVL 9181 whole blood 0 9897 0 084 0 9865 0 11 2 8 9 6 314 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 Selectivit
170. of gas remaining Baro Displays the current barometric pressure Next Event Displays the time remaining to the next calibration AutoQC measurement The Ready display also provides access to the following system functions Data Manager This menu allows you to print out patient and control information It also provides you with the ability to export information if the OPTI R is connected to a computer For more information on printing information see Chapter 4 Calibration and Quality Control and Chapter 5 Patient Testing QC Manager This menu allows you to set up and perform AutoQC and manual control measurements For more information see Chapter 4 Calibration and Quality Control System Manager This menu contains the following settings and functions Time and Date see Chapter 3 2 Diagnostics see Chapter 7 2 Setup see Chapter 3 3 Utilities see Chapter 6 6 Operator s Manual OPTI R Analyzer 3 CUSTOMIZATION 9 CUSTOMIZATION 45442424 3 1 3 1 Data Manager sn ET 3 1 3 2 Setting Time And tte 3 1 S3 SCUD ME 3 2 3 3 1 Customizing Patient Information 3 3 3 3 1 1 Selecting Which Patient Information is Requested and Printed 3 3 3 3 1 2 Selecting Which Parameters Are DBlankedisabled 3 5 3 3 1 3 Selecting Which Calculated Parameters Are Printed rrrrnnnrnrnnnrnrrnnnrnrnnnrnrnnnerrnnnrennnnne 3 6
171. on 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 OPTI R Analyzer 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 p
172. osis 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 1s 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 10 et which describes how the fluorescence emission intensity increases as the blood pH 1s increased above the dye s characteristic 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
173. ottles as well as user input bar codes for operator and patient IDs Fig 1 5 Fig 1 5 Bar Code Scanner Thermal Printer The thermal printer is accessed by raising the door on the top of the unit Fig 1 6 The printer uses heat sensitive paper to output information in 27 columns The analyzer can print measured values quality control values calibration values as well as patient and diagnostic information Fig 1 6 Thermal Printer Peristaltic Pump Contained within the same compartment is a peristaltic pump cartridge which is used to transport liquids and gases Fig 1 7 NOTE The peristaltic pump cartridge is a replaceable item See Maintenance Section 6 4 1 Fig 1 7 Peristaltic Pump Operator s Manual OPTI R Analyzer 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 u c unit Fig 1 8 15 1 g J d H A D E D 1 vk E ii sunm n s H Il Is un Ue A e d i LIE t e hd LI Fig 1 8 Model and Serial Numbers Back of Analyzer CF Slot On the rear of the unit 1s Fig 1 9 e An RS232 interface port e An Ethernet interface port Ille Hn s e An OPTI R Fluid Pack Compartment which er incorporates a sensor that detects the presence of a Fluid Pack Fluid Pack RS232 Ethernet Compartmen
174. per day with 2 replicates per run for 20 days on each of two OPTI R instruments PO is expressed in mmHg Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level 1 71 4 4 84 6 8 1 07 1 5 2 27 3 2 Level 2 99 3 22 142 3 1 44 1 5 3 42 3 4 Level 3 139 3 2 88 2 1 1 53 1 1 5 46 3 9 Serum 100 9 2 00 2 0 1 05 1 0 2 99 3 0 Reduced Bovine Hemoglobin 95 6 2 16 2 2 0 95 1 0 2 24 2 3 Solution All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method 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 2 replicates were run on each of three OPTI R systems All values are in mmHg Expected n Observed Swr bias Recovery 34 2 5 35 6 0 32 1 4 104 47 9 6 48 2 0 99 0 4 101 81 4 6 835 2 47 2 1 103 142 9 6 139 4 1 09 3 5 98 96 413 7 4 410 8 LI 2 9 99 PO2 2 Operator s Manual OPTI R Analyzer ANALYTES PO Linearity Wherever possible linearity for the OPTI R measurement has been established against
175. perator s Manual OPTI R Analyzer 1 In the Ready display press lt QC Manager gt 2 Select lt Auto QC gt in the lt RUN gt menu Fig 4 14 3 Enter your Operator ID or 4 digit PIN using the alphanumeric keypad Fig 4 15 To bypass this function press OK NOTE If Operator ID is configured as required in Setup you cannot go to the next step until a number is entered NOTE If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner 4 Select the desired level Fig 4 16 and press OK 4 9 4 CALIBRATION AND QUALITY CONTROL Control ee p Progress 5 The QC sample is aspirated into the cassette and the measurement starts Fig 4 17 Measuring SS Fig 4 17 Auto QC measurement OC gt Auto OC gt Results Upon completion of the measurement the results are displayed and printed Fig 4 18 s pra perraro 6 The OPTI R Analyzer will indicate whether the values are within or outside the programmed ranges with a lt Pass Fail gt display next to the Ehe parameter label LA 7 Press Up lto return to lt QC Manager gt H neon Fig 4 18 Auto QC results 4 10 Operator s Manual OPTI R Analyzer Ready 10 40 12 Nov Run Setup Auto QC Control Q ve Sp Home Fig 4 19 Select Cont
176. perator ID and or Accession No is required and still not entered this error will be displayed e Press OK to edit the patient data and add the required information new printout will be given with the required information Two or more measured parameter sensors are bad e Press OK discard the cassette and repeat the test with a new cassette The instrument could not clear the buffer from the cassette e Press d nd go to lt System Manager gt Utilities gt to perform a lt Master Calibration gt The gas bottle has expired or you have used an invalid bar code NOTE The gas bottle expires 9 months after installation or after exceeding the labeled expiration date whichever comes first e Check the gas bottle label Make sure it is for this particular gas bottle and the expiration date has not been exceeded If expired insert a new gas bottle e Check proper date setting in lt System gt Time and Date gt The cassette was not properly placed into the chamber e Open the SMC cover e Reinsert the cassette and verify proper seating e Press OK to continue OR e Press Cancel to return to the Ready display and retry after installing a new cassette Operator s Manual OPTI R Analyzer ERROR Cassette Misseat 2 Re insert Cassette OK Cancel i ERROR Cassette Misseat 2 Discard Cassette OK p ERROR Bad Cassette Discard Cassette K ER
177. place Now x Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The PIN number already exists in database e Press OK Ito continue e Enter a unique PIN number The OPTI R received no response from the host computer e Press Yes to retry If the problem persists e Check connection between the OPTI R and the host computer e Check the OPTI R s communication configuration under lt System gt Hardware gt e Check the host computer The OPTI R received a negative NAK response from the host computer e Press Yes to retry If the problem persists e Check the host computer or contact the facility IT manager This error may occur during the 3 month calibration The error is triggered when the correction is greater than 30 e Replace the calibrator The gas cylinder is empty e Replace the gas cylinder and press OK 7 9 7 DIAGNOSTICS AND TROUBLESHOOTING STOP System Error Cycle Power for Reset STOP Memory Error Database Deleted STOP Need New QC Data Must Run Controls STOP Temperature Out of Range x 7 10 The instrument has detected an internal error e Discard the cassette e Turn the power off wait 30 seconds and then turn the power back on Patient QC and other databases were deleted e Press OK lend the instrument will reinitialize If QC lockout has been activated in Setup this message will be display
178. r da m ge i V me KS Emm OK Cancel Fig 6 34 Insert Gas Bottle Fig 6 35 New Gas Bottle Operator s Manual OPTI R Analyzer 6 MAINTENANCE Take a new gas bottle and remove its cap When prompted Fig 6 33 scan the new gas bottle bar code by holding it 2 3 inches 5 8 cm from the bar code scanner located on the bottom right hand corner of the analyzer e The red line from the barcode scanner should cover the entire barcode e The analyzer will beep when the barcode is accepted e The barcode can be found on the gas bottle instructional insert e Record the date of installation on the gas bottle for later reference NOTE To enter the bar code manually press lt Manual gt and enter the bar code using the numeric keypad NOTE The gas bottle should always be stored with the cap on NOTE The bar code contains expiration information The OPTI R will alert the operator two weeks before the gas bottle expires Insert the bottle into its housing and turn it clockwise until finger tight Fig 6 34 Press OK In the New Gas Bottle gt screen Fig 6 35 press Yes to confirm the installation of a new gas bottle 6 13 6 MAINTENANCE Enter Weeks Gas Bottle in Use Cancel OK Measurement Ready Samples em Start Sample Pack Measurement Gas 50 Baro 732 4 Next Event 05 16 Run Sample Data QC System Manager Manager Manager
179. r Hardware Entry gt Fig 3 6 vp Home Fig 3 6 Select Patient Entry Not Ready 10 40 12 Nov 3 Inthe lt Info 1 gt screen select the options to be System Setup Patient Information oe enabled Fig 3 7 Defaults opea fere 4 Select Optional or Required for Operator ID Perpa m Patient ID Accession Sung per Operator ID Accession Number Temperature bk Sex d 5 Other options to be selected are DOE le Ho Type F Temperature eng Defaults EH Save Sex e Up f Home Date of Birth DOB Hb Type Fig 3 7 Patient Info 1 6 Press the lt Info 2 gt tab to access and enable the System Setup Patient Information c following parameters Fig 3 8 Puede TIER HON zs Puncture Site Liter Flow Bypass TVOL VT r Bypass TVOL VT Sample Type PS r O2 Mode PEEP E Sample Type PS VE Ratio M Rates r O Mode PEEP Vent mode 7 CPAP r VE Ratio Rate f Polat User Defined r MOLVE E rd Vent Mode CPAP Pressure a Pplat User defined field om Defaults f sae MVOL VE Bilevel Pressure Qv Up gt Home PIP Fig 3 8 Patient Info 2 Operator s Manual OPTI R Analyzer 3 3 3 CUSTOMIZATION System gt Setup gt Patient Information Info 1 tHb w 150 es FIO2 m 021 Edit MCHC o 33 3 edt RQ g 0 84 DEd P50 7 aer 000 Edt cancel Defaults gl Save I Fig 3 9 Defaults 3 4 The lt Defaults gt screen
180. rators of blood gas equipment in hospital laboratories The blood was analyzed on the OPTI R 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 Chiron whole blood 0 8371 0 246 0 9641 0 040 0 3 1 4 92 Roche OMNI whole blood 0 8151 0 20 0 9564 0 03 0 85 2 19 314 AVL 9181 whole blood 0 9628 0 096 0 9550 0 03 0 86 2 0 314 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Burritt MF Pierides AM Offord KP Comparative studies of total and ionized serum calcium values in normal subjects and in patients with renal disorders Mayo Clinic proc 55 606 1980 3 Tsien R New Calcium Indicators and Buffers with High Selectivity Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 4 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 5 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI R Analyzer Ca 3 ANALYTES tHb SO Total Hemoglobin Concentration ctHb and Hemoglobin Oxygen Saturation SO Clinical Significance total Hemoglobin concentration ctHb The he
181. re run on each of three OPTI R systems All values are in mmHg Expected n Observed Swr bias Recovery 17 1 6 18 8 1 47 1 7 110 27 4 6 21 2 0 60 0 2 99 96 40 7 6 42 8 1 40 2 1 105 74 5 6 74 5 2 86 0 1 100 82 1 4 80 5 1 10 1 6 96 Linearity Wherever possible linearity for the OPTI R 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 R systems Correlation Slope Intercept Coefficient Sy x Range n 0 9636 2 143 0 99860 1 47 17 82 27 Correlation to Other Methods OPTI R 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 R 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 Chiron whole blood 0 9510 0 828 0 9684 1 80 11 65 94 Roche OMNI whole blood 1 0615 3 44 0 9923 2 22 19 140 314 PCO2 2 Operator s Manual OPTI R Analyzer ANALYTES PCO References 1 Tiet
182. 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 R systems Correlation Slope Intercept Coefficient Sy x Range n 0 9914 0 928 0 99989 2 26 34 414 27 Correlation to Other Methods OPTI R 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 R 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 Chiron whole blood 0 9362 10 32 0 9947 13 21 19 575 92 Roche OMNI whole blood 1 0640 6 58 0 9910 5 48 21 279 314 References 1 Tietz Norbert W Ed Clinical Guide to Laboratory Tests 2nd Ed Philadelphia W B Saunders Co 1990 p 436 2 Kautsky H Quenching of Luminescence by Oxygen Transactions Faraday Society 35 p 216 1939 3 CDL 3M Healthcare System 200 Extracorporeal Blood Gas Monitor See for example Lubbers DW Gehrich J Opitz N Fiber Optics Coupled Flourescence Sensors for Continuous Monitoring of Blood Gases in
183. 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 Use as a Blood Gas Quality Control Material Clin Chem 39 5 874 79 1993 J B Henry Clinical Diagnosis and Management by Laboratory Methods 19th Ed 1996 p 590 777 Operator s Manual OPTI R Analyzer 8 11 8 OPERATING PRINCIPLES 8 5 10 Interferences Selected substances endogenous and exogenous to human blood were tested for interference in accord with CLSI EP7 A2 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 R 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 followi
184. ring aspiration and automatic detection of low gas dirty optics or worn pump conditions Once the cassette is calibrated it is ready for use Operator s Manual OPTI R Analyzer 8 9 8 OPERATING PRINCIPLES 8 5 6 Quality Control The OPTI R utilizes three independent solutions contained in the fluid pack for performing automatic quality control These solutions are completely independent from calibrating solutions and provide three unique levels of analyte concentration The Auto QC function can be programmed to run up to five times per day and perform as many as three levels per run Details on programming Auto QC can be found in Chapter 3 Customization of this manual On initial use of a new cassette validation is performed by analysis of each of the three Auto QC solutions It is recommended to run one level of control every shift or at a minimum two levels every 24 hours All specific performance specifications reported in this summary are determined from the above minimal recommendations for quality control verification 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 For agencies requiring a liquid QC material OPTI CHECK is available OPTI CHECK is a specially formulated aqueous liquid control material that contains all analytes measurable by the OPTI R It contains a stable suspension of polystyrene m
185. ringe capillary or ComfortSampler 10 30 C 50 86 F 5 to 95 non condensing optical fluorescence pH PO PCO Na K Ca and reflectance tHb SO Default Display Units Resolution Blank Blank Blank 37 0 0 1 C 0 1 oF adult LR Off Pump Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES Parameter Range Default Display Units Resolution Sample Type Total hemoglobin tHb Mean corpuscular hemoglobin concentration MCHC O2 Mode FIO 2 respiratory quotient RQ P 50 Vent Mode Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous Mix Ven Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass 1 to 26 1 to 260 0 6 to 16 1 29 0 to 37 0 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 0 21 to 1 0 0 70 to 2 00 15 to 40 No SIMV PSV PCV CMV AC CPAP PCIVR or BIPAP where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation Operator s Manual OPTI R Analyzer Art 15 0 33 3 Rm Air 0 21 0 84 20 7 No 0 1 g dL l mg dL 0 1 mmol L 0 1 0 01 0 10 0 1 mmHg 8 7 8 OPERATING PRINCIPLES Parameter Range Default Display Units Resolution PCV Pressure Con
186. rinted After printout the database can be deleted by pressing AC Delete Before the database is deleted enter the password to initiate the procedure if a password has been activated under lt Setup gt Press T Home to return to the Ready display Press Install Slope Data Fig 4 32 to view data from pack and cassette installations The installation data will apply the pack limits set by OPTI Medical The Install Slope Data menu will also allow you to view the slope check data obtained 4 CALIBRATION AND QUALITY CONTROL 4 5 3 2 Printing External Control Reports 4 16 Ready 10 40 12 Nov Measurements Diagnostics Patient Install Slope Auto QC Data Calibration Print Miscellaneous Reports Configuration Q up Home Fig 4 35 Select Controls Data gt Control Measurement Ready 10 40 12 Nov Level Date Foose 1 mos 10001 12Jul12 09 51 x 0005 1 12Jul12 13 23 Leu BUM D wel i ee 9 10 0008 Statistics Up Home Fig 4 36 Control Measurement Data gt Control Measurement View E Ed eee Limits P t cum KN MN Kl Fa see m vers Ra gt Home Fig 4 37 View Control Results 7 8 8 pH PO Na KA 50 42 Kol pa 20 e Your OPTI R can print reports containing information on the mean Standard Deviation SD and Coeff cient of Variation CV of stored Q
187. rinting External Control Reports secs eee nns 4 16 4 5 4 Sending Data to a Computer rrnrnrranornnnrnanrnnnnnvanrnnanernnnrnnnrnnnnnnanennanennnnennnennanenanennnne 4 17 4 6 Calibration e 4 18 5 SAMPLE HANDLING AND PATIENT TESTING 5 1 5 1 Specimen Collection and Handling 5 1 MEE NN 5 1 5 1 2 Sample Requirements rarerarerarerarenannnnrennrnnnrnnnrnnnrnnnennnennnennnennernnnennennnennsennsennsenunennnen 5 1 5 1 3 Anticoagulants and Sample Collection Devices rrrarrnnnrrnnrrnranennnrnnnnrvnnrnrnnennanennnennnnnn 5 1 sw Se 5 1 5 1 5 Capillary Tubes RTT 5 2 S16 Real Rer tee le 5 2 5 1 7 Handling and Storage of SN 5 2 SLO NNN 5 4 5 2 Sample PreparatiOnh ranrnnrnnunnnnnnunnunnnnnnnnnunnunnnnnnnnnunnnnnnnnnunnnnnnnnnunnnnnnnnnunnnnnuenne 5 4 5 2 1 Whole Blood Samples ETT 5 4 5 3 Running A Patient Sample rannrnnnnnnnnnnnnnnnnnnnnnnnnennnnnnunnnennnvnnunnnnnnnnnnunnnennnnnnnenn 5 5 5 4 Printing Patient E Le ln oorr pong cUxidaius t Dota OE EP iE uris git irte 5 11 II Operator s Manual OPTI R Analyzer TABLE OF CONTENTS 6 MAINTENANCE ee 6 1 61 Daly Maintenant EN 6 1 EVI V AUrlcde ie e 6 1 6 3 Quarterly Maintenance Running the Calibrator 6 1 64 Semiann al E ah dE Le n6 xUFRENREIESY
188. rol Enter Operator ID ESESESRESESE ES EES EES EEE EES TS EEE ABE SIE KEES EE Space Fig 4 20 Enter Operator ID QC Controls Ready 10 40 12 Nov Select Level 1 2 3 Cancel OK Fig 4 21 Select QC Level Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL 4 5 2 2 Running an External QC Sample OPTI CHECK The OPTI R is factory preset to perform an automatic QC measurement in the AutoQC mode every 8 hours It is also possible to perform external QC measurements using controls such as OPTI CHECK which do NOT contain dye or other colored material Store controls at temperature recommended by the manufacturer The target value of PO2 is very sensitive to storage conditions and barometric pressure High altitude environments may see recovery outside the target range l In the Ready display press QC Manager 2 Select Control in the lt RUN gt menu Fig 4 19 3 Enter your Operator ID or 4 digit PIN using the alphanumeric keypad Fig 4 20 To bypass this function press OK NOTE If Operator ID is configured as required in Setup you cannot go to the next step until a number is entered NOTE If Secure Op IDs is activated under Setup you will be prompted for your 4 digit PIN instead of your Op ID NOTE Bar coded Operator IDs may be entered using the bar code scanner 4 Select the desired level Fig 4 21 and press
189. rror Displays WARNING No Sample Detected WARNING Unstable pH WARNING Bad Sensor pH OK Cancel i Operator s Manual OPTI R Analyzer Sensors did not see any sample Make sure sample is properly attached and not clotted and does not contain air bubbles Wait for the system to recalibrate e Remix sample carefully e Press OK to notify the system that the sample is reattached and reaspirate sample Unstable pH PCO or PO or other measured parameter NOTE This message is a warning The analyzer will however display a result for the parameter concerned e Repeat sample measurement The pH PCO or other measured parameter sensor is bad e You have the option of continuing the measurement by pressing OK or stopping by pressing cancel If you continue no results will be provided for the bad sensor or any calculated result which utilizes this measurement in its calculation 7 1 7 DIAGNOSTICS AND TROUBLESHOOTING WARNING Bubble Detected K E WARNING Possible Clog K E WARNING Calibrator Expired Run Calibrator before installing cassette K WARNING List is Full K WARNING QC L1 not detected Check Fluidics K i 1 2 A bubble was detected at the light gates e Confirm the message by pressing oK and let the instrument clear the error through automatic cassette wash e Remix sample and rerun e Make sure a
190. rtSamplers sias uixbvaets cibum Geet 8 4 8 4 7 Handling and Storage of Samples 8 4 8 5 Procedure Mert Nene 8 5 e WW Ee e ME 8 5 8 5 2 Test Conditions E 8 6 Soto le e Et AU 8 6 DTTV 8 9 on FN 8 9 8 5 6 ENEE Seiretnbsteegegegeg gue AE eege geen 8 10 OO RAAEN ln E EE 8 10 8 5 8 Specific Performance Characherstce 8 10 oe EE Be 0 EEE EE 8 11 8 5 10 NETTENE 8 12 8 011 PENN 8 13 IV Operator s Manual OPTI R Analyzer TABLE OF CONTENTS 9 LINEARITY AND CORRELATIONS eren nnne 9 1 9 1 Instrument Setup and Preparation cesses eee nennen nnn 9 1 9 2 Aqueous Quality Control Testing eee ERR eee eee rennen 9 1 9 3 Performing a Patient AnalysiS anrnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnunnn 9 2 9 4 Recording and Evaluating the Data cesses 9 2 Patient Sample Data Sheet veden 9 3 10 SUPPLIES eoe EEEE 10 1 Wii r2 PREMIUM 10 1 VE e CI UT IO EE 10 1 10 3 GOMUlGIS C lee TC 10 1 10 4 Consumable ltems rarrnnennrnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnunnnnnnnnnunnnnnnennunnuenne 10 2 UE EE 10 2 1005 MB 10 2 Vr Spare Pas rv 10 3 10 8 Technical ASSistance r rraxrarrannannnnnnnnnnnnnnnnnnunnunnnnnunnunnunnunnnnnnnnnnnnnnnnnnnnnnnennee 10 3 10 9 Warranty Registration U S Market Only 10 4 ANAL
191. ry kit e One shutdown cassette part number BP7111 supplied with the accessory kit l Select System Manager gt Utilities from the Ready menu 2 In the Utilities menu select Shutdown to start this procedure Fig 6 50 3 Inthe following display Fig 6 51 press Yes to start the shutdown procedure 4 When prompted Fig 6 52 remove the Fluid Pack and push the protective strip supplied with the accessory kit firmly onto the Fluid Pack connector 6 19 6 MAINTENANCE 6 20 syste m gt Utilities gt Shutdown Insert Shut Down Pack Syste m gt Utilities gt Shutdown Not Ready 10 40 12 Nov Fig 6 54 Insert blue line Syste m gt Utilities gt Shutdown Mot Ready 10 40 12 Nov Insert Red Line into Waste Container OK Fig 6 55 Insert red line 5 Next insert the shutdown pack carefully in the fluid pack receptacle Fig 6 53 6 Then place the line with the blue band into the disposable container filled with water Fig 6 54 Press ok 7 The line with the red band is placed into the empty container Fig 6 55 Press ox Operator s Manual OPTI R Analyzer 6 MAINTENANCE Syste m gt Utilities gt Shutdown Not Ready 10 40 12 Nov Open Cover 8 Open the cover of the sample measurement chamber Fig 6 56 Cancel Fig 6 56 Open Cover Syste m gt Utilities gt Shutdown Mot Ready Insert Shutdown Cassette 9 Insert the shu
192. s 0 2 to 3 0 0 01 mmol L Operator s Manual OPTI R Analyzer Ca 1 CALCIUM ANALYTES Reference Intervals Sample type Range mmol L Serum and plasma Adults 1 15 1 33 Interferences The OPTI R Ca sensor does exhibit an interference from bisulfate and phenylacetic acid Heparin salts are the only acceptable anticoagulants Other anticoagulants such as citrate EDTA oxalate and fluoride cause significant interferences to the electrolyte sensors The following exogenous interferents were quantified in tonometered plasma showing interferences to dyes which typically have short half lives within the body before being metabolized by the liver Substance amount Ca change mmol L Sodium fluorescein 25 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 brand aqueous controls should be used with the OPTI R system Colored materials including proficiency testing materials may interfere with the pH or ion measurement or fail to be properly aspirated Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from I run per day with 2 replicates per run for 20 days on each of two OPTI R instruments Ionized calcium values are expressed in mmol L Material mean Swr CV Sdd CV ST CV OPTI CHECK aqueous control solution Level 1 1 526 0 034 2 2 0 022 1 4 0 039 2 6
193. s Page 5 of 5 Barcode Printer Optics Gas Test Pump Display R3232 Ethemet Print Emor Flaw Test Report Fig 7 23 Select Touch Test System gt Diagnostics gt Touch Test 10 40 Mot Ready 12 Nov Please Verify Touch Calibration Defaults n Home Perform Touch Test fel Sawe Please Touch and Hold Target Fig 7 25 Perform Touch Calibration 7 26 The purpose of this test is to check the proper operation of the touch screen From the lt Ready gt display press lt System Manager gt Diagnostics gt In the lt Diagnostics Sensors gt screen press Gp Next repeatedly to access the lt Tests gt screen Page 5 of 5 e Press Touch to start the test Fig 7 23 e Touch the screen and a dot should appear under the touched location Fig 7 24 e If not press lt Calibrate gt to perform a touch calibration Fig 7 25 e Press JP to return to the System screen e Using a finger stylus or pointed object e g syringe adapter touch the center of the calibration mark as it moves around the screen Fig 7 25 NOTE Do not use sharp objects since they may damage the screen e When finished press l Save Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 17 Checking the RS232 Interface System gt Diagnostics The purpose of this test is to check for proper EA EEE functioning of the serial interface Tes
194. s display appears press Yes to install a new gas bottle If after the initial installation you need to remove a gas bottle and reinstall the same bottle respond ME to the prompt lt New Gas Bottle gt The next screen will prompt you to enter the number of weeks in service using the numeric keypad See section 6 5 3 Here you may refer back to the installation date which was recorded on the gas bottle Operator s Manual OPTI R Analyzer NotReady A 1040 12Nov F Samples Gas Not Ready em No Cassette C Data QC System Manager Manager Manager e t2nov10 13 Nocassete v Fig 2 15 Installing new cassette Baro 7324 Not Ready 1040 12 Nov Scan Cassette Barcode Manual Cancel Fig 2 16 Scan cassette bar code Syste m gt Utilities gt New Cassette Install Not Ready Open Cover Cancel Fig 2 17 Open SMC Cover Operator s Manual OPTI R Analyzer 2 SETUP Installing the Sensor Cassette After installation of the OPTI R gas bottle is complete this display appears Fig 2 15 Press lt Install Cassette gt Scan the bar code 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 until the bar code labeled Scan A is recognized Fig 2 16 The red line from the bar code scanner should cover the entire bar code A beep and a green
195. s experience and these samples more closely reflect the testing of patient samples Proficiency testing may also serve to expand your Quality Control testing by providing samples with different levels of analytes than those measured in the daily testing program The relative testing performance of each laboratory participating in the proficiency survey Is determined by comparing test results obtained from a significantly large group of laboratories using the same or similar instrumentation CAUTION Use proficiency material that is clear Do not use material that contains dyes or emulsions The Joint Commission on Accreditation of Healthcare Organizations JCAHO has published a protocol for establishing a quality assurance program The Health Care Financing Administration HCFA and the Clinical and Laboratory Standards Institute CLSI formerly NCCLS have published standards for quality assurance in medical laboratories Operator s Manual OPTI R Analyzer 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 R Analyte Section included in this manual provides precision and recovery data for all the measured parameters in the ranges that are usually encountered in the diagnostic
196. s if capable of transmitting human immunodeficiency virus HIV hepatitis B virus HBV or other bloodborne pathogens Proper blood collection techniques must be followed in order to minimize risk to the laboratory staff and gloves should be worn Please refer to CLSI document M29 A3 Protection of Laboratory Workers from Occupationally Acquired Infections Approved Guideline Third Edition March 2005 for further information on safe handling of these specimens 8 4 2 Sample Requirements Refer to NCCLS 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 8 4 3 Anticoagulants and Sample Collection Devices Lithium heparin is the only acceptable anticoagulant for blood gas and electrolyte analysis Lithium heparin sodium heparin or balanced heparin salts are the only acceptable anticoagulants for blood gas analysis Other anticoagulants such as EDTA citrate oxylate and fluoride have a significant effect on blood pH and electrolyte levels and should not be used Lithium heparin should not be used for samples taken also for analysis of lithium 8 4 4 Syri
197. scellaneous Re ports DA Configuration Home Fig 4 32 Select Auto QC Qu Data gt Auto OC Measurement Ready 10 40 12 Nov SZ Level Date PIF soos NUN EC ecd T sl T zmurzem rase B 7 Tamra wes Pass Statistics Up 45 Home Fig 4 33 Auto QC Measurement Le Data gt Auto QC Measureme nt gt Vlew Para Result Limits Pass I meter Fail PO2 8 8886 926 Na i K 5 O2 we sr emm vac wr m vs ra Up rere Fig 4 34 Auto QC Results ser me 42 ere Pw s e ser asesor ass 20 Operator s Manual OPTI R Analyzer and Coefficient of Variation CV of stored Auto QC data l 10 In the lt Ready gt display select lt Data Manager gt Press lt Auto QC gt Fig 4 32 In the lt Data Auto QC Measurement gt screen Fig 4 33 press the view button to display the Control results Fig 4 34 Use the Jue fand 199 buttons to display the previous or next page of results To print individual results highlight the desired measurement Fig 4 33 To print groups of results highlight the first measurement to be printed press Qe We then select the last measurement to be printed All the measurements in between will be selected Press G to select all results Print Press Geh to print your selection Press the lt Statistics gt button and select the levels for which statistics are to be p
198. scitation Hood Hood Other Other 0 21 1 0 0 70 2 00 15 40 No SIMV PSV PCV CMV AC CPAP PCIVR BIPAP PRVC where No None SIMV Synchronized Intermittent Mandatory Ventilation PSV Pressure Support Ventilation PCV Pressure Control Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure PRVC Pressure Regulated Volume Control 0 4000 0 120 0 140 0 100 0 99 9 0 50 0 50 0 155 000 00 300 00 0 2 9 9 0 2 9 9 0 2 9 9 0 2 9 9 9 alphanumeric characters A 3 APPENDIX A TECHNICAL SPECIFICATIONS Calculated Values Actual bicarbonate HCO 1 0 200 0 mmol L Base excess BE 40 40 mmol L Base excess ecf BE 40 40 mmol L Base excess actual BE 40 40 mmol L Buffer bases BB 0 0 100 0 mmol L Total CO tCO 1 0 200 0 mmol L Standard bicarbonate st HCO 1 0 200 0 mmol L Standard pH st pH 6 500 8 000 Oxygen saturation SO 0 0 100 0 Oxygen content O ct 0 0 56 0 mL dL Hematocrit Hct c 15 75 Hydrogen ion concentration cH 10 0 1000 0 nmol L Alveolar arterial oxygen partial pressure 0 0 800 0 mmHg difference AaDO P50 15 0 35 0 mmHg nCa 0 1 3 0 mmol L Temperature Corrected Values Parameter Display Resolution Lo Hi pH 6 6 7 8 0 01
199. similar to most CO oximeters Substance amount ctHb change g dL SO change EXOGENOUS Cardio Indocyanine Green 0 5 mg dL 5 0 3 5 Evan s Blue 5 0 mg dL 17 Methylene Blue 25 mg dL 3 4 Low ENDOGENOUS Carboxyhemoglobin 10 2 2 22 Carboxyhemoglobin 20 3 3 lt 2 Methemoglobin 20 4 5 7 Rapidly sedimenting blood samples should be mixed thoroughly and immediately aspirated into the OPTI cassette as described above in Handling and Storage of Samples to ensure accurate tHb measurements If allowed to sediment the blood sample s reported tHb may be falsely high or low Fetal hemoglobin taken from cord blood extracts was tested and showed no interference to the tHb and SO measurement Reproducibility Typical Within Run Swr Between Day Sdd and Total ST Precision is determined from 1 run per day with 2 replicates per run for 20 days on each of two OPTI R instruments ctHb is expressed in g dL and SO in Material mean Swr CV Sdd CV ST CV OPTI CHECK Level 1 ctHb 20 0 0 34 1 7 0 06 0 3 0 43 2 1 aqueous control solution SO2 78 9 0 47 0 6 0 10 0 1 0 47 0 6 OPTI CHECK Level 2 ctHb 14 1 0 20 1 4 0 18 1 3 0 44 3 1 aqueous control solution SO2 84 4 0 62 0 7 0 50 0 6 1 02 1 2 OPTI CHECK Level 3 ctHb 9 3 0 15 1 6 0 13 1 4 0 29 3 1 aqueous control solution SO2 91 2 0 73 0 8 0 81 0 9 1 22 1 3 All specific performance characteristics tests were r
200. spiration lt 2 minutes typically approx I minute to result 10 C 30 C 50 F 86 F 5 95 non condensing optical fluorescence for tHb SO optical absorbance reflectance 15 alphanumeric characters 11 alphanumeric characters 12 alphanumeric characters 14 44 C 58 111 F male female or MMM DD YYYY adult or fetal LR RR LB RB LF RF Cord Scalp where LR Left Radial RR Right Radial LB Left Brachial RB Right Brachial LF Left Femoral RF Right Femoral Cord Cord Scalp Scalp Off Pump On Pump Art Ven Mix Ven Cap Cord CPB where Art Arterial Ven Venous Mix Ven Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass I 26 g dL 10 260 mg dL 0 6 16 1 mmol L 29 0 37 0 Operator s Manual OPTI R Analyzer O Mode FIO Respiratory quotient RQ P50 Vent Mode Tidal Volume TVol VT Minute Volume MVOL VE Peak Inspiratory Pressure PIP Plateau Pressure Pplat Pressure Support Value PS Positive End Expiratory Pressure PEEP Continuous Positive Airway Pressure CPAP Rate f Flow Rate Liter Flow FR Inspiratory Expiratory Ratio I E Ratio BiLevel Pressure User Field 1 2 and 3 Operator s Manual OPTI R Analyzer APPENDIX A TECHNICAL SPECIFICATIONS 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 resu
201. status light indicate a valid bar code A red status light indicates an invalid bar code e g cassette expired Read the message on the analyzer display for detailed information See Chapter 7 Troubleshooting Next turn the cassette pouch over and hold in front of the scanner until bar code Scan B is read appropriately A beep and a green status light indicate a valid bar code NOTE If the bar code is damaged or unreadable press lt Manual Entry gt and enter the bar code digits using the keypad Slide the latch up and press the release button to open the Sample Measurement Chamber SMC Fig 2 17 2 2 SETUP Syste m gt Utilities gt New Cassette Install Not Ready Open Pouch and Wipe Cassette SJ Insert Cassette p K N Cancel Fig 2 18 Open Packet and Insert Cassette Syste m gt Utilities gt New Cassette Install Not Ready 10 40 Close Cover Cancel Fig 2 19 Close Cover New Component Checks Completed Conditioning m Master Cal AOC Level 3 m AQC Level 2 AQC Level 1 Master Gal E Fig 2 20 New Component Checks 2 8 e Insert the cassette as follows e Open the OPTI R Sensor Cassette packet and remove the cassette from the pouch Fig 2 18 NOTE If possible avoid tearing the two bar codes when opening the cassette pouch e Gently wipe both sides of the cassette with a clean dry cloth to remove excess moisture e Insert the casse
202. stems Inc 235 Hembree Park Drive Roswell GA 30076 USA www optimedical com PD7032 REV K 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
203. syringe adapter during aspiration Fig 4 24 It is recommended to utilize a new ampoule of control material for each analyzer 7 Push the capillary tube or syringe firmly into the fillport or syringe adapter respectively Fig 4 25 and Fig 4 26 Operator s Manual OPTI R Analyzer Sample Aspiration In Progress Please Wait Fig 4 27 Sample Aspiration QC gt Controls Measuring Please Remove Sample x Fig 4 28 Remove Sample Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL CAUTION When using a syringe withdraw the ampoule contents slowly to minimize agitation and do not allow bubbles to move through the syringe 8 Press _ The QC sample is aspirated into the cassette Fig 4 27 9 Once the sample is drawn into the analyzer you will be prompted to remove the sample and press ok Fig 4 28 4 13 4 CALIBRATION AND QUALITY CONTROL QC Controls Measuring Control Measurement In Progress Please Wait Measuring Fig 4 29 QC Measurement QC Controls Results Para Result Pass Fail meter 7417 7 431 PASS PCO2 39 1 41 1 PO2 886 926 PASS tHb 6 00 6 10 PASS SO2 132 PASS Fig 4 30 QC Results QC Controls Results Measuring 10 40 12 Nov Gontrol Results Accept Fig 4 31 Accept QC Results 4 14 Then the measurement starts Fig 4 29 At this time the status light begins flashing gr
204. t Port Port e A Compact Flash Card slot CF Slot for software updates or storage of patient and QC Fig 1 9 Back of the OPTIR data ina CSV file Power Connector and On Off Switch On the left side of the unit is the power connector where you can connect the OPTI R to an external power supply Fig 1 10 The On Off switch is located on the left side of the unit next to the power connector Fig 1 10 NOTE Allow a 30 second delay when switching the power ON OFF Fig 1 10 Power Connector and On Off Switch Operator s Manual OPTI R Analyzer 1 5 Shutdown Pack ET E rs VET ee ht i a d Fig 1 11 Shutdown Pack Consumables OPTI R Cassette Fig 1 12 OPTI R Cassette Sample Fillport and Syringe Adapter Fig 1 13 Sample Fillport and Syringe Adapter Operator s Manual OPTI R Analyzer 1 INTRODUCTION The OPTI R Analyzer comes with a Shutdown Pack Fig 1 11 which is used to perform a complete shutdown of the analyzer e Once the analyzer is in use do not turn the power off for an extended period of time gt 72 Hours without performing a complete shutdown procedure see Maintenance Section 6 6 3 2 e Ifthe analyzer is not being used for less than 72 hours it is recommended to perform a powerdown instead of a shutdown see Section 6 6 3 1 The reusable OPTI R Cassette has an integral valve to control the fluid flow Fig 1 12 The sample fillport is contained in the OP
205. t Setup Auto OC Not Ready 10 40 12 Nov Range Range Na L Edit e e K 4 Edit Fr e Ca Edit r tHb Edit e C SO2 4 Edit e S 9 Back Page 3 of 5 Che Fig 4 4 Adjust Auto QC Ranges QC gt Setup Auto QC suppressed Flagged Ze U AGC Failure Enable Activate Rilibak Stat Sample P Print Auto QC Report P Back Page of 5 ENext E cancel fal Save G Up Fy Home mM Fig 4 5 Select Auto QC Options Operator s Manual OPTI R Analyzer 4 CALIBRATION AND QUALITY CONTROL Adjust Auto QC ranges This menu allows you to change the Auto QC limits either by a range or percent from the target value programmed in the fluid pack The ranges can only be tightened from the target value and the target value can not be changed l 2 Select the Auto QC level Fig 4 3 Select lt Range or lt gt for each parameter that you would like to change Press the Edit button and enter the desired value for the range Press Net to access page 3 of the Auto QC setup and edit the Na K Ca tHb and SO ranges Fig 4 4 Or press ESSI to save the changes Adjust ranges for electrolytes and tHb and SCH Press f Save to save the changes Go to the previous screen to change the next level of Auto QC Press Next to access page 4 of the Auto QC setup for more Auto QC Options Fig 4 5 Miscellaneous Auto OC Opt
206. t Setup gt screen or f Home to return to Ready 3 5 3 CUSTOMIZATION 3 3 1 3 Selecting Which Calculated Parameters Are Printed 3 6 Not Ready 10 40 Customize Patient Information Patient Entry i t it Miscellaneous Nomal Ranges Alarm Limits Security H Uu Measured Parameters Correlation Printer Language 12 Nov Calculated Parameters Units Hardware Q Up F Home Fig 3 12 Select Calculated Parameters System gt Setup gt Calculated Parameters Not Ready Cassette Type M BE HO HCUS3 BB BEact BEecf Enable Enable sIHCO3 5L pH cH nicae Hct c y SOZek fw r r c e r AaDOz 2Ct P50Ct Enable F r r cancel Defaults fa Save Qe om Fig 3 13 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 From the Ready display select lt System Manager gt and lt Setup gt 2 Inthe lt System Setup gt menu press lt Calculated Parameters gt Fig 3 12 Select the cassette type Fig 3 13 4 Select the parameters to be printed 5 Press see to accept the changes 6 Press ka P to return to the lt Setup gt
207. t Sy x Range n Chiron whole blood 0 9121 13 16 0 8923 1 99 123 146 95 Roche OMNI whole blood 1 0087 2 24 0 8996 230 126 158 314 AVL 9181 whole blood 0 8824 16 39 0 8966 2 34 123 158 314 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 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 4 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Na 4 Operator s Manual OPTI R Analyzer ANALYTES POTASSIUM Potassium K Clinical Significance Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the cell itself Ninety percent of potassium is concentrated within the cell and damaged cells release potassium into the blood Potassium plays an important role in nerve conduction muscle function and helps maintain acid base balance and osmotic pressure Elevated potassium levels hyperkalemia can be found in oligouria anemia urinary obstruction renal failure due to nephritis or shock metabolic or respiratory acidosis renal tubular acidosis with the K H exchange and hemolysis of the blood Low
208. t is not activated In the Configuration menu Fig 3 29 you can select printer location printer connection printer port and printer IP address 1 Select the options to be enabled 2 Press od to accept the changes 3 Press Q Up to return to the Setup screen Or f Home to return to Ready Operator s Manual OPTI R Analyzer 3 CUSTOMIZATION 3 3 2 6 Entering the Barometric Pressure Not Ready 10 40 12 Nov Customize Patient Information Measured Calculated Miscellaneous Normal Ranges Correlation Units Alarm Limits Security Printer um Language Qu f Home Fig 3 30 Select Hardware System gt Setup gt Hardware Barometer Current Offset Offset 740 mmHg Edit Beep Enable B Beep Volume je p 10 60 Backlight Auto off Of Min Min Mode e c E cancel Defaults y Save Q Up Home Fig 3 31 Enter barometric pressure Operator s Manual OPTI R Analyzer The Hardware menu consists of three screens Settings Interface and Ethernet The Settings screen is used to adjust your local barometric pressure the audible alarm and automatic backlight function The Interface and Ethernet screens can be used to configure communication settings To adjust the tracking barometer within the OPTI R follow the instructions below l From the Ready display select System Manager and Setup
209. t this time you may continue entering or editing the patient information until you have completed it or display the results immediately by pressing Q Up at any time EG If the screen has not been touched for approximately three 3 minutes the results will automatically be displayed Fig 5 15 The second tab displays the calculated parameters Fig 5 16 15 Press Qu to move directly to the next sample display e If 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 resolution of the measured parameters may be configured HIGH Na 156 4 mmol L or LOW Na 156 mmol L in the setup menu See section 3 3 2 3 e The OPTI R Analyzer flags values that are above or below the programmed ranges with an up or down arrow If the value is outside the measurable range a HIGH or LOW will be displayed and a gt or lt with a range printed out on the patient report 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 WARNING Treatment should never be administered based on results that are flagged on the printout Operator s Manual OPTI R Analyzer 5 4 Printing Patient Reports Ready 10 40 12 Nov Measurements Diagnostics
210. ta press Edit Use the alphanumeric keypad to type in the desired information Press og to save the information entered 8 Pressing YNE will access subsequent patient data entry screens Fig 5 9 MCHC default value 33 3 RQ default value 0 84 P default value 26 7 mmHg Blanking NOTE Parameter blanking will omit a parameter from the printout See Section 3 3 1 2 for detailed description 5 7 5 SAMPLE HANDLING AND PATIENT TESTING Measurement gt Patient Data Measuring 10 40 12 Nov 9 Hb Type Adult Fetal C C Sample Type Art Ven Mix Ven C r Cap Con CPB eC E C Puncture Site RR LE RE Ir C LF RF Cord Scalp e c C e Back Page 3 of7 E Next Finish Fig 5 10 Edit patient data 3 Measurement gt Patie nt Data Measuring 10 40 12 Nov Vent Mode Ha SIMY PSV PCY CMV AC UC C C CPAP PCIVR BPAP PAVE C C E C 02 Mode RmAir Mask T P NC fr C rm Vent Bag Hood Other e C E Bypass off pump on pump C C Back Page 4 of 7 Ej Next Finish Fig 5 11 Edit patient data 4 5 8 10 3 Next Press again and the following patient information is displayed Fig 5 10 e Hb Type adult or fetal default is adult e Patient Sample Type Art Ven MixVen Cap Cord CPB where Art Arterial Ven Venous Mix Ven Mixed Venous Cap Capillary Cord Cord CPB Cardio Pulmonary Bypass e Puncture Si
211. tdown cassette Fig 6 57 Cancel Fig 6 57 Insert Shutdown Cassette Syste m Utilities gt Shutdown Not Ready Close Cover 10 Close the SMC cover Fig 6 58 Cancel Fig 6 58 Close Cover Operator s Manual OPTI R Analyzer 6 21 6 MAINTENANCE 6 22 Syste m gt Utilities gt Shutdown Not Ready 10 40 12 Nov system Busy Please Wait Fig 6 59 Shutdown procedure syste m gt Utilities gt Shutdown Mot Ready 10 40 12 Nov Remove Blue Line from Water Leave Red Waste Line in Place Fig 6 60 Remove blue line syste m gt Utilities gt Shutdown Not Ready 10 40 12 Nov Remove Red Line From Waste Container and Remove Shutdown Pack Fig 6 61 Remove red line and Shutdown Pack The analyzer will flush all lines with water for approximately one minute Fig 6 59 11 Upon completion remove the line with the blue band from the water container and place it on a cloth making sure not to obstruct the line The line with the red band remains in its container Fig 6 60 Press ox During this cycle all lines are purged of air 12 Upon completion you will be prompted to remove the red line and the shutdown pack Fig 6 61 Operator s Manual OPTI R Analyzer 6 MAINTENANCE Syste m gt Utilities gt Shutdown Not Ready 10 40 12 Nov Remove Cassette and Close Cover 13 Open the SMC cover remove the shutdown M cassette and close the cover Fig 6 62
212. te LR RR LB RB LF RF Cord Scalp where LR Left Radial LB Left Brachial LF Left Femoral Cord Cord Press Next Fig 5 11 RR Right Radial RB Right Brachial RF Right Femoral Scalp Scalp for the following information e 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 e 02 Mode Rm Air Mask T P NC Vent Bag Hood Other where RmAir Room Air Mask Mask T P T Piece NC Nasal Canula Vent Vent Bag Bag Manual Resuscitation Hood Hood Other Other e Bypass Off pump or on pump Operator s Manual OPTI R Analyzer Measurement gt Patient Data Measuring 10 40 12 Nov PEEP Heat CPAP me e Rate a Liter Flow heat TVol VT mn em MVol VE ms ed Pplat ed Back Page 5 of7 E Next Fig 5 12 Edit patient data 5 Measurement gt Patient Data Measuring 10 40 12 Nov Bilevel Pressure Edt 1 Ect Back Page 6 of 7 Net Finish eem Fig 5 13 Edit patient data 6 Measurement gt Patie nt D
213. testing of patients Should a laboratory wish to perform a calibration verification for measurement values outside the broad range OPTI Medical Systems suggests tonometry of whole blood for PO and PCO correlation against flame photometry for electrolytes correlation against cyanmethemoglobin method for tHb and blood pH correlation with conventional blood gas analyzers QC Recommendations Policies regarding the measurement of QC samples are established by the individual hospital The OPTI R 1s factory preset to perform an automatic QC measurement in the AutoQC mode every 8 hours It is also possible to perform external QC measurements using controls such as OPTI CHECK which do NOT contain dye or other colored material Whenever a new lot of control 1s opened be sure to enter the lot information into the analyzer as described below These materials should provide target values for pH PCO and all other measured parameters over a range of measurement values typically seen in each testing site laboratory The results obtained should fall within limits defined by the day to day variability as measured in the user s laboratory facility OPTI Medical Systems recommends the use of a noncolored pH blood gas electrolyte control containing scattering particles for tHb control for routine evaluation of imprecision as a part of an effective quality control program Operator s Manual OPTI R Analyzer 4 3 4 CALIBRATION AND QUALITY CONTROL
214. the left side of the printer See Fig 6 38 Close the top cover of the analyzer and tear off any excess paper Fig 6 40 6 MAINTENANCE 6 5 5 Performing Routine Cleaning 6 6 6 16 The OPTI R Analyzer is designed to require very little maintenance Routine cleaning consists of wiping the exterior analyzer surfaces with a soft damp cloth WARNING Never use strong or abrasive cleaners on the OPTI R Analyzer System Utilities The lt Utilities gt menu contains the following functions lt Calibrator gt lt Master Calibration gt lt Powerdown gt and Shutdown procedures e Inthe main menu press lt System Manager gt Fig 6 41 to access the lt System gt menu Press lt Utilities gt Fig 6 42 and the lt System gt Utilities gt screen will appear Fig 6 43 Measurement System gt Utilities Ready 10 40 12 Nov Not Ready 10 40 12 Nov Not Ready 10 40 12 Nov Samples Installation Utilities 59 Start Sample Pack Measurement Time and Date Diagnostics 83 Calibrator Run Gas 50 B 7324 Setup Ce X gt Master Calibration Run anm Next Event 05 16 Run Sample Power Control Data QC System Powerdown ShutDown Manager Manager Manager JU Q Up Fy Home Q Up Za Home Fig 6 41 System Manager Fig 6 42 Select Utilities Fig 6 43 System Utilities Operator s Manual OPTI R Analyzer 6 6 1 Calibrator see 6 3 1 Quarterly Maintenance 6 6 2 Master Cal
215. the rear SMC port Close valve 5 WARNING The following steps are to be performed using biohazard protection Connect the syringe to the front SMC port and apply light pressure The port should be blocked Fig 7 55 Apply Pressure to Front SMC Port Remove the pump cartridge place a paper towel over the front pump receptacle and repeat above step the fluid path should be open to the front pump receptacle Fig 7 55 Remove the fluid pack and connect the syringe to the rear pump receptacle While holding a paper towel over the fluid pack receptacle slowly depress the syringe The fluid path should be open to the fluid pack receptacle Operator s Manual OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING 18 Remove the paper towel and block the top port of the fluid pack receptacle with the gloved finger Slightly pressurize the syringe and check for the tube to be blocked Fig 7 56 Fig 7 56 Apply pressure to rear pump port 7 3 2 Clog Removal In case the above checks yielded a blocked fluid line proceed as follows 1 Remove the fluid pack and the valve cartridge 2 Once the valve cartridge is removed the 4 fluid ports indicated need to be checked cleared with the stylette Fig 7 57 3 Gently insert the stylette into each of the ports Fig 7 57 Insert stylette into the valve cartridge ports Operator s Manual OPTI R Analyzer 7 39 7 DIAGNOSTICS AND TROUBLESHOOTING 4 Remove the flui
216. tle see Section 6 5 3 If error persists perform Fluidics Trouble shooting section 7 3 This prompt indicates that no cassette is present or that the current cassette is invalid The cassette may be invalid because it expired or it was rejected e Install a new sensor cassette see Section 6 5 1 Operator s Manual OPTI R Analyzer Operator s Manual eens i 10 40 12 Nov i Samples A Pack Not Ready Gas Cassette Expired Baro Remove Cassette 732 4 install Cassette Data QC System Manager Manager Manager i 12 Nov 10 13 Cassette Expired I Not Ready Samples 0 Pack Not Ready Cassette Expired wn QC Limit Reached Gas 732 4 install Cassette Data QC System Manager Manager Manager i 12 Nov 10 13 Cassette Expired NotReady A 1040 12 Nov 8 Samples 0 rc A 83 Gas Not Ready Cassette Rejected install Cassette QC System Manager Manager Manager NotReady A 1040 12 Nov 0 Pack 83 Gas Not Ready Temperature Out 732 4 of Range Temp 331C Data QC System ideen ta eer Manager OPTI R Analyzer 7 DIAGNOSTICS AND TROUBLESHOOTING The cassette has reached the maximum of 50 patient samples or its in use limit of 7 days e Replace the cassette see Section 6 5 1 The cassette has reached the maximum of 42 QC samples e Replace the cassette see Section 6 5 1 The cassette fai
217. trol Ventilation CMV AC Controlled Mechanical Ventilation Assist Control CPAP Continuous Positive Airway Pressure PCIVR Pressure Control Inverse Ratio BIPAP Bi Level Positive Airway Pressure Tidal Volume VT 0 to 4000 0 1 mL Minute Volume VE 0 to 120 0 1 L Peak Inspiratory Pressure PIP 0 to 140 0 1 Plateau Pressure Pplat 0 to 100 0 0 1 Pressure Support Value PS 0 to 99 9 0 0 1 Positive End Expiratory 0 to 50 0 1 Pressure PEEP Continuous Positive Airway 0 to 50 0 1 Pressure CPAP Rate f 0 to 155 0 1 bpm Flow Rate Liter Flow FR 0 to 300 0 1 LPM Inspiratory Expiratory Ratio 0 2 9 9 0 2 9 9 0 0 0 1 I E Ratio Bi Level Pressure 0 2 9 9 0 2 9 9 0 0 0 1 User Field 1 2 3 9 alphanumeric characters Blank 8 8 Operator s Manual OPTI R Analyzer 8 OPERATING PRINCIPLES 8 5 4 Calculated Values Parameter Range Display Units Resolution Actual bicarbonate HCO I 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 a 40 to 40 0 1 mmol L Buffer base BB 0 to 100 0 1 mmol L Total CO tCO I to 200 0 1 mmol L Standard bicarbonate st HCO 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 l Hydrogen ion concentration cH 1000 to 10 0 1 nmol L Alveolar arterial oxygen difference
218. ts Page 5 of 5 E 2 From the lt Ready gt display press lt System Manager gt Diagnostics gt at a iind pana In the lt Diagnostics Sensors gt screen press Touch m D Ethemet Next repeatedly to access the Tests screen ay Page 5 of 5 Print Emor pen SS e Press lt RS232 gt to start the test Fig 7 26 Back Next Or om Fig 7 26 RS232 Interface RS232 Test sid e tis important to have pins 2 and 3 send and receive see Appendix A p A 6 shorted Limpar pme 2102 together Fig 7 27 OK e Press o and the system will send out a test string and check if it can be received Fig 7 27 Jumper Pins 2 to 3 Rszs2test e The instrument will display a Pass or lt Fail gt message Fig 7 28 RS232 PASS Fig 7 28 Interface Test Pass e Press ox to return to the Tests screen Operator s Manual OPTI R Analyzer 7 27 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 18 Checking the Ethernet Interface 7 28 System gt Diagnostics Not Ready 10 40 12 Nov Tests Page 5of 5 Barcode Printer Optics Gas Test Pump Display Touch RS232 ee Print Emor Flow Test Report Back gt Next Q ve Home Fig 7 29 Ethernet TTE Test Connect Network Cable Fig 7 30 Connect Network Cable System gt Diagnostics gt Ethernet Not Ready 10 40 12 Nov Connection Status Connected Duration 23 days 03 00 00 Speed 100 0 Mbps IP Address 1
219. tte in the chamber e Press down to ensure the cassette is properly seated Fig 2 18 e Close the SMC cover by pressing the SMC cover down firmly Fig 2 19 NOTE The user should not remove the cassette unless prompted to do so Removal of the cassette without being prompted will cause premature expiration of the sensor cassette 8 1 New Component Checks After a new fluid pack or cassette is installed the system will check the integrity of the fluid pack and cassette and calibrate The instrument will display the status of the five major steps during installation Preconditioning stabilizes the cassette sensors The Master Calibration 1s performed using the calibration buffer and the gas bottle This is followed by a measurement of all three AQC levels Finally a second calibration is performed This calibration maximizes the number of samples that can be run once the analyzer is in ready mode Fig 2 20 Operator s Manual OPTI R Analyzer Measurement Ready 10 40 12 Nov Run STATSample F Fig 2 21 STAT Sample Option Operator s Manual OPTI R Analyzer 2 SETUP 8 2 STAT Sample Option during Cassette Installation If the lt STAT Sample gt option is enabled in the Auto QC menu see Section 4 5 1 1 Setting up Auto QC the analyzer will allow you to run STAT Samples during a cassette or fluid pack installation The analyzer will perform a cassette calibration and then
220. ty 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 and their effects and means of management throughout the process e simple statistical calculations which provide a means of assessing precision e control charts or graphs which contain warning limits to assist the technical staff in the evaluation of results e 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 previou
221. un with default instrument calibration and after normal recommended equipment quality control checks were performed see Operator s Manual Specimens at each level were analyzed in replicates of two for 20 days The within run and between day standard deviations were calculated by the analysis of variance method Operator s Manual OPTI R Analyzer THB SO2 3 tHb SO ANALYTES Linearity Wherever possible linearity for the OPTI R measurement has been established against reference materials or methods Total hemoglobin content linearity is established by the photometric determination of cyanmethemoglobin 6 No standard method exists for the measurement of oxygen saturation For the purpose of evaluation SO linearity is evaluated against a target oxygen saturation in a normal human blood sample Correlation Slope Intercept Coefficient Sy x Range n Total Hemoglobin 0 9850 0 334 0 98901 1 107 5 5 23 5 40 SO2 0 9573 3 43 0 99898 0 879 40 100 40 Correlation to Other Methods OPTI R 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 R after obtaining the requisite results from existing instrumentation used for these analyses and operated and controlled following their established procedures Correlatio
222. up menu it must be entered prior to deleting data from the database 0 11 6 MAINTENANCE 6 MAINTENANE La 6 1 6 1 Daily Maintenance nnnnnnnnnnennnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnennunnnnnnnnnnnnnnunnnennnnnnuenn 6 1 6 2 Weekly Maintenance annnnnnnnnnnnnnnnunnnnnnunnnunnnnnnnnnnunnnnnnnnnnunnnnnnnnnnunnnunnnnnnnnnnunnn 6 1 6 3 Quarterly Maintenance Running the Calibrator 6 1 64 Semiannual Waintenman e tege eeh SEENEN EE EDMNRRNRSNNEBEKNENUUEINREAN RUN NEIN ERN RENNES ER 6 5 6 4 1 Replacing Peri Pump Cartridge srrnnnrnnnnnnanennnnrnannnnnnnnnnnnnanennnnnnanennnnnnanrnnanenanennnnennnne 6 5 6 4 2 Replacing SMC UORorte 6 6 6 5 As Needed Maintenance annnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnennennnnnnnnne 6 7 65 1 Changing une 6 7 052 Changing the er 6 10 6 5 3 Changing ING Gas e EE 6 12 6 5 4 Changing the Printer Paper uiia erant t ae erme Gare 6 14 055 Performing Routine CIGANING BE 6 15 6 6 System UtilitieS anrrnnnnnnernnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnnennnnnnnunnnnr 6 15 bol TN 6 16 66 2 M ster CAMO QUO EEE 6 16 6 6 9 Taking out of ODSFalIQIsuasaeieeed nnm eerste EEN egene 6 17 6 6 3 1 Powerdown PTE ONE ser 6 17 6 6 3 2 Shutdown Procedure srscacecescadccsteaasscncuiasersescateasasnccaaandiagcioasnttaancaBantnoanensaesateeeoeraddoessnnercse 6 18 Operator s Manual OPTI R Analyzer 6 i 6 1
223. urementPatient Data MCHC Edit RQ fed P50 fed Blanking Enable Enable pH E Cat PCO2 B K r PO B tHb SO2 r Ma E Back Page 2 of7 CS Next Finish em Fig 5 9 Edit patient data 2 Operator s Manual OPTI R Analyzer 5 SAMPLE HANDLING AND PATIENT TESTING e Press the Last Patient Info button Fig 5 7 to use the last patient info as the default for the current patient info e This option will populate all patient info fields with the last patient data including patient ID and operator ID numbers If operator ID security is enabled the operator ID field will display the operator ID of the last patient sample All patient information used as the default can be edited e Verify that patient ID operator ID and all other input parameters are correct for every patient sample measurement e Press the Patient Info button to enter new patient info or to not use the last patient info as the default 6 The first patient data entry screen contains the following information Fig 5 8 Operator ID 11 alphanumeric characters Patient ID 15 alphanumeric characters Accession No 12 alphanumeric characters Date of Birth DOB Temperature default value 37 0 C tHb default value 1s 15 0 g dL FIO default value 0 21 Sex unknown male or female NOTE Patient and Operator IDs and Accession numbers may be entered using the bar code scanner 7 To enter patient da
224. ve the cassette 2 Goto lt Diagnostics Control gt and open valve 0 3 Attach service syringe to the rear SMC port and gently pull Fig 7 54 Clear buffer should be aspirated with little or no bubbles If the line is blocked follow the blockage removal procedure 7 3 2 Fig 7 54 Aspirate from rear SMC Port 4 Close valve 0 and open valve 2 5 Attach service syringe to the rear SMC port and gently pull Cloudy buffer should be aspirated with little or no bubbles If the line is blocked follow the blockage removal procedure 7 3 2 6 Close valve 2 and open valve 3 7 Attach service syringe to the rear SMC port and gently pull Clear buffer should be aspirated with little or no bubbles If the line is blocked follow the blockage removal procedure 7 3 2 8 Close valve 3 and open valve 4 9 Attach service syringe to the rear SMC port and gently pull White colored buffer should be aspirated with little or no bubbles If the line 1s blocked follow the blockage removal procedure 7 3 2 Operator s Manual OPTI R Analyzer 7 37 7 DIAGNOSTICS AND TROUBLESHOOTING 10 11 12 13 14 15 Paper towel 16 17 7 38 Close valve 4 and open valve 5 Attach service syringe to the rear SMC port and gently pull After some buffer residue air should be aspirated from the vent port With gas bottle in place leave valve 5 open then cycle valve 1 open then closed Gas should come out
225. y Against Magnesium and Protons Biochemistry 19 p 2396 2404 1980 3 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 4 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b K 4 Operator s Manual OPTI R Analyzer ANALYTES CALCIUM lonized Calcium Ca Clinical Significance Calcium in blood is distributed as free calcium ions 50 bound to protein mostly albumin 40 and 10 bound to anions such as bicarbonate citrate phosphate and lactate However only ionized calcium can be used by the body in such vital processes as muscular contraction cardiac function transmission of nerve impulses and blood clotting The OPTI R 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
226. y be changed See section 3 3 3 3 e In all data input screens if unreasonable numbers are entered the system automatically flags the error and displays the valid range e f you wish to turn off limits flagging enter the system ranges for each parameter For instance for pH the low 1s 6 600 and the high 1s 7 800 See Analytes Section for specifications of the reportable ranges for each parameter measured e The limits entered here will reside in the instrument memory even after system power is turned off 8 Press UP to return to the Setup screen or Home to return to lt Ready gt Operator s Manual OPTI R Analyzer 3 3 2 2 Setting up Correlation Factors Not Ready 10 40 12 Nov Customize Patient Information i Measured Calculated Patient el Parameters Parameters Miscellaneous Normal Ranges Correlation b Units Alarm Limits eet Security Printer Hardware Language Q ve F Home Fig 3 18 Select Correlation Syste m gt Setup gt Correlation 10 40 Factors2 Offset pH 1 00 geat ooo edt PCO2 100 geat oommhg ra PO2 100 get 0ommHg amp d cancel Defaults H Save Q Up Home Fig 3 19 Correlation Factors 1 System Setup Correlation Not Ready m Factors 1 slope tHb 10 edt 0 0 Ledt SO2 10 Seat Poo Edt cancel Defaults pl Save Q Up Home Fig 3 20 Correlation Factors 2 Oper
227. y gt display press lt System Manager gt Diagnostics gt The lt Temperature gt option lets you check the various system temperatures lt Top Plate gt lt Bottom Plate gt lt Wash Buffer gt lt Ambient gt and lt Preheater gt Fig 7 3 NOTE If top or bottom plate temperatures are out of range the temperature display will change to red The purpose of this test is to check proper functioning of the LEDs This test should be performed only by trained service personnel From the lt Ready gt display press lt System Manager gt Diagnostics gt The following information 1s displayed in the lt LEDs gt section Fig 7 4 e Front lt Rear gt lon Waste fluid light gates e Cassette Misseat gt detector located in cover e Cassette Detect gt sensor e SMC Cover this test function indicates whether the SMC cover is closed or open screen 7 17 7 DIAGNOSTICS AND TROUBLESHOOTING 7 2 4 Verifying Barometric Pressure System gt Diagnostics This menu displays the current barometric pressure Not Ready 10 40 12 Nov Sensors Page 1 of 5 From the Ready display press GE 1 00 0000 1 00 0000 System Manager gt Diagnostics gt Optics Module OF EZH bestoe SED 2 e The Miscellaneous section will show the Bottom Plate 307 C Prhewer 317 C current barometric pressure Fig 7 5 Wash Bufer 317 C EE Ce e Ifthe barometric pressure requires adjustment Re
228. ype 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 optodes are closely related to the more familiar Ion Selective Electrodes ISEs The optodes use ion selective recognition elements ionophores similar to those used in ISEs however the ionophores are linked to fluorescent dyes instead of electrodes These types of dyes have been used since the 1970 s to visualize and quantify cellular ion levels in fluorescence microscopy and cell counters As the ion concentration increases these ionophores bind larger amounts of ions and cause the fluorescence intensity to increase or decrease depending on the particular ion L
229. ystem is designed to measure whole blood serum or plasma to be controlled with aqueous solutions Aqueous controls are portable and quite convenient to use with the OPTI R system however their low oxygen carrying capacity and temperature sensitivity is well known Measurements of such materials are more prone to pre analytic error as well as analyzer specific errors compared to similar measurements of whole blood The OPTI R 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 R 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 R 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
230. yzer 7 2 21 Diagnostic Reports Measurements 7 DIAGNOSTICS AND TROUBLESHOOTING This option allows you to print diagnostic reports From the Ready display press lt Data Manager gt to access the lt Data gt screen Patient Control Fig 7 38 Auto QC ae The lt Diagnostics gt tab contains the following reports en lt Patient gt lt Control gt lt Auto QC gt lt Install Slope Data gt lt Calibration gt and lt Event Log gt Event Log Up Home Fig 7 38 Data Manager 7 2 21 1 Patient Diagnostic Report Data gt Patlent Diagnostics Ready 1040 12 Nov The Patient Diagnostic Report contains information about the measured signal in millivolts 21 un12 and drifts observed during measurement m x e e e gY Up Ta Home Fig 7 39 Select Measurement Data gt Patient Diagnostics gt View Ready 10 40 12 Nov Para mV Drift T W meter PH 223 0 24 33 102 PCO 301 3 04 33 103 6259 28 33 112 180 11 00 33 105 4524 72 33 93 4913 09 9 108 e Eu Home LB e Fig 7 40 Patient Diagnostics Operator s Manual OPTI R Analyzer To print a patient diagnostics report select Diagnostics gt Patient in the Data screen Fig 7 38 In the Data Patient Diagnostics screen Fig 7 39 select the desired measurement and press the View button to
231. z 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 Tietz Burtis C et al Eds Textbook of Clinical Chemistry and Molecular Diagnostics 4 Ed Elsevier Saunders 2006 pps 2252 2302 4 Model equation for regression statistics is results of OPTI Analyzer slope m comparative method results intercept b Operator s Manual OPTI R Analyzer PCO2 3 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 measure blood PO in 1983 The relationship of luminescence to PO is quantified

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OPTI™ R Analyzer - OPTI Medical Systems