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1. 5011 IR TEMP OUT OF SPEC DURING CAL e e e e 5012 O2 CAL IS ON RAIL e e 5013 O2 CAL TIMEOUT e 5016 Final O2 result greater than 1000 mm Hg 133 3 kPa 5017 Final CO2 result is negative e 5018 Final CO2 result is greater than 200 mm Hg 26 7 kPa Diametrics Medical Inc Wet or dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Faulty IR probe which requires replacement Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge Problem with Sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge Problem with Sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Instrument not equilibrated to new environment 30 minutes is required Faulty IR probe which requires replacement Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridg
2. 5210 CI DRIFT CORRECTION OUT e Problem with Sample p e Malfunctioning cartridge 5301 GL CAL CHECK LOW Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5320 GL OUT OF RANGE LOW e Problem with Sample e Malfunctioning cartridge 5321 GL OUT OF RANGE HIGH e Problem with Sample Diametrics Medical Inc Pg 50 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS Malfunctioning cartridge 5322 O2 CR too low e Problem with Sample possibly low or no oxygen e Malfunctioning cartridge 5323 Sample Amp 1 Drift too negative 5324 Amp1 CR 2 and 3 Don t Match at Low Level 5325 Amp1 CR 1 and 2 Don t Match at High Level Problem with Sample Malfunctioning cartridge e Problem with Sample e Malfunctioning cartridge e Problem with Sample Malfunctioning cartridge 5326 Amp1 CR 2 and 3 Don t Match e Problem with Sample e Malfunctioning cartridge 5327 Amp1 Glucose out of Range High e Problem with Sample e Malfunctioning cartridge 5328 Amp1 Glucose out of Range Low e Problem with Sample e Malfunctioning cartridge 5329 G
3. or too cold 12C e IRMA was recently within the past hour moved from an environment that is extremely low or high temperature e Broken temp measurement circuit General Status 101002 Checks power into main PCB Input voltage too high Above 10V Noise 106001 106014 Checks if there is excessive noise on non sensor data channels Noise 5 Volt Regulator Failure on sensor channels is measured during tests and uses different methods Electromagnetic Interference EMT E end for filtering Latent circuit failure Leakage 108001 Checks for null leakage on MEMB channel without generating a Extremely high humidity stimulus leakage current on other pins this channel is not currently Contamination on MEMB channel on main circuit board used for anything but maybe someday Latent circuit failure Leakage 108002 Checks for null leakage on ILEAK channel without generating a Extremely high humidity stimulus leakage current on other pins This is the circuit we use for a Contamination on ILEAK channel on main circuit board lot ofthe leakage testing Latent circuit failure Leakage 108003 Checks for null leakage on ISE1 channel without generating a stimulus Extremely high humidity leakage current on other pins Contamination on ISE1 channel on main circuit board Latent circuit failure Leakage 108004 Checks leakage between ISE1 and other pins not WKG1 3 or Heater Contaminated Edge Connector Low Extremely high humidity Contamination between chann
4. 2 10 hours depending on battery type its condition and existing charge Be sure to leave the battery in the charger until the green LED flashes continuously The green LED on the charger will begin to blink blinks for 30 seconds off for 4 seconds blinks for 30 sec Etc when the battery is at approx 90 capacity When it reaches 100 capacity the green light will blink continuously Batteries should remain in the charger until the green LED blinks continuously Paper Can any paper be used in IRMA No Philips sells the only paper type recommended for use in IRMA Diametrics Medical Inc Pg 3 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Barometric Pressure Is the barometric pressure switch active in IRMA Yes IRMA uses an active barometer that 1s constantly measuring the barometric pressure How often should the barometer be calibrated Annually using a National Institute of Standards and Technology NIST traceable barometer Adjust the IRMA barometer if it is not within 5 mmHg of the NIST barometer reading Do not use a water barometer or airport barometric pressure readings IRMA How much does IRMA weigh 5 pounds 4 ounces What is IRMA s size 11 5 x 9 5 x 5 What is IRMA s operating temperature IRMA v 5 0 and higher 12 30 C 54 86 F IRMA v 4 x x and lowe
5. Dirty Meter 660 Internal failure of the SSP module Error generated by Lifescan SW Replace module Sample applied to wrong side of glucose strip 25 26 24 Glucose Reserved 4 N A 25 Glucose Strip Removed Glucose strip removed before test could complete 26 Glucose KS Error 660 1 Internal failure of the SSP module Error generated by Lifescan SW Replace module Diametrics Medical Inc Pg 55 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS 27 Glucose KS Error 940 Last Internal failure of the SSP module Error generated by Lifescan SW Replace module 28 Glucose Floating Pt Error 3 Internal failure of the SSP module Error generated by Lifescan SW Replace module 29 Glucose Strip Jitters Internal failure of the SSP module Error generated by Lifescan SW Replace module 30 Glucose Power Off in Test Internal failure of the SSP module Error generated by Lifescan SW Replace module Glucose ROM Checksum 3 Internal failure of the SSP module Error generated by Lifescan SW Replace module 32 Glucose KS Error 660 2 Internal failure of the SSP module Error generated by Lifescan SW Replace module 33 Glucose Autoscale Error Internal failure of the SSP module Error generated by Lifescan SW Replace module 34 Glucose Floating Pt Error 4 Internal failure
6. analysis with different ampule If repeat is within range the system is ready for patient testing Be sure to record any actions taken in action log d If still out determine if the room temperature of testing area has shifted significantly for every 1 C change in temperature a 1 change in gas value will be seen Record any observations or actions taken in action log e If still having problems contact Diametrics technical support at 1 800 949 4762 3 If the value is just outside of range follow the established protocol for your facility This may be to accept the value and allow patient testing to continue while the next quality control results are monitored Diametrics Medical Inc Pg 28 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use P N 463200 Rev 6 APPENDIX C Electronic Quality Control Diametrics Medical Inc manufactures the IRMA SL Blood Analysis System This point of care instrument analyzes blood gases sodium potassium ionized calcium and hematocrit and employs the use of Electronic Quality Control EQC as a way of assessing and documenting the accuracy and precision of the system Electronic Quality Control Quality control is performed through a comprehensive diagnostic check of the edge connector internal electronics and analyte circuitry An EQC test simulates the electronic signals that are produced by IRMA sen
7. be returned to Diametrics Pg 24 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use P N 463200 Rev 6 APPENDIX A Aqueous Quality Control Introduction amp Intended Use With the IRMA SL Blood Analysis System Quality Control can be performed through two methods electronic and aqueous controls It is important to follow the control manufacturer s recommended procedures for storage and equilibration of the control material prior to analysis on the IRMA SL Instructions for Use Equilibrate ampules at room temperature 18 25 C for at least 4 hours before use ES SOOO Ico Un ee I5 Hold the ampule by its tip and shake it vigorously for 10 seconds Tap the liquid back into the base of the ampule Sampling must take place within 2 minutes of opening the ampule Enter User ID optional at the display prompt on the IRMA SL Analyzer Initiate the Quality Control Test Sequence Open the foil pouch and remove the cartridge Remove the protective tape from the cartridge Insert the cartridge into the analyzer Verify cartridge type inserted if necessary Verify or enter the cartridge information at the display prompt Select the control from the list of established controls After calibration is complete carefully snap open the control ampule To avoid cuts protect your fingers with tissue or gloves or use an ampule b
8. different power supply and or cord Make sure wall outlet has power Yes Return charger for service Diametrics Medical Inc Pg 11 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use AC ADAPTER FAILURE 7 Replace if still under warranty No power while using an AC Adapter Customer purchase new one if out of warranty Diametrics Medical Inc Pg 12 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use CARTRIDGE FAILURES Reservoir bag broken Cartridge leaking Cartridge not recognized Sensor Errors Diametrics Medical Inc BM BD Remind customer to never use a cartridge from a pouch with a broken reservoir bag and credit account for the cartridge Do not return to DMI for investigation Report Lot number to DMI Is top and bottom of cartridge snapped down completely Is ceramic chip seated properly Do not return to DMI for investigation Report lot number and manufacturing issue to DMI Credit account for the cartridge Make sure customer is not inserting EQC TEMP card in patient test mode Do not return to DMI for investigation Report lot number to DMI and credit customer for the cartridge Have customer supply usage log From Main Menu press Recall Er
9. high humidity Contamination on WKGI channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on WKG2 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on WKG3 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Pg 35 Test Type Error Codes Description of Test POSSIBLE CAUSE Leakage 108077 Checks leakage from MF4 multifunction 1 pin to reference pins and e Contaminated Edge Connector heater low e Extremely high humidity e Contamination between channels on main circuit board e latent circuit failure ISEREF 109001 109005 Checks the ISEREF circuit by introducing 5 voltages acr
10. may be felt since the sample must displace the calibration gel Stop injecting when the gel has been displaced and blood is covering the sensors Slowly inject additional sample to displace bubbles gel or to reach the minimum sample volume of 200uL Leave the collection device attached to the cartridge until the analysis is complete Note The initial injection should pop the calibrant out of the sample path If you can see the blood pushing the calibrant out of the sample path then you are injecting too slow Correlation When would a customer typically decide to use the correlation option How should correlation data be collected When there is a significant consistent bias between IRMA and their reference analyzer for a particular analyte AND the facility routinely uses both IRMA and the reference for testing and wants them to read the same e g routine batch testing on reference STAT testing on IRMA Correlation factors are based on split sample blood results from a statistically valid number of samples Follow the instructions in Section 7 of the IRMA User Manual How is the data analyzed Graph the reference analyzer results against the IRMA analyzer results for each set of values Plot the results for each analyte separately Make the reference analyzer results the Y dependent variable make the IRMA analyzer the X independent variable Perform linear regression analysis on the results Delete any data
11. or replace Malfunctioning cartridge 5045 Na NOT RESPONDING QUICKLY CAL Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5046 Ca NOT RESPONDING QUICKLY CAL Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 44 ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS e Malfunctioning cartridge 5047 K NOT RESPONDING QUICKLY CAL Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5 e Malfunctioning cartridge e Malfunctioning cartridge 5050 HCT PHASE 0 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartri
12. 1 APPENDIX E INTERNAL HOC ERROR CODES 5 drcivesoizicdePu taU epERLadb sea Fe qon EuEE2 VE PR EE daupitcesccanuassceannisabdencsseussiasiaucsticaadssaitesunsss 32 APPENDIX F TEMPERATURE TEST ERROR CODES eee ee eene eee eene sette ose sete ta sese step asses eeeo se sete ea aes eee ea ness e tease e teen ae 39 APPENDIX G USAGE LOG ERROR CODPES 1irtepnoipockee best iov oa da uuva Irae epe asp euev ede enp ope sa ao eria cuu e dinde s FR prdO Urea Debes ye iex E a ed QE PER aora UR 41 APPENDIX H MEDICAL USEFULNESS CRITERIA ssccsssssscscccssacsessessisc ssecssisscesusadocsausisccessaaaasscedasscesdabsoescasscasassdsacasdodsaasecseasoasas 59 APPENDIX I PROFICIENCY SURVEY INFORMAT ION ecce ee esee eese en sese seen eo se eet ea se eee eas e esos e ee ea aes sete eaae see een see seta ae 60 APPENDIX J REGULATORY MADE SIMPLE 5 5 rte rhbsid rea dpa ey done Va euo D rb aa ao eoe eR euo e GE VP e aa beta nare rero Quo ee E AR Ou PUTANS Ee DU eH Meno PER M Ro o bARo 61 Diametrics Medical Inc Pg 2 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Question amp Answer Section P N 463200 Rev 6 Subject Question Answer Quality Control What kind of aqueous quality control material may be used on IRMA DMI recommends and supports RNA Medical Quality Control materials Other aqueous quality control mate
13. Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISEREF channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISEI channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Pg 33 Test Type Error Codes 108037 108038 108041 108042 108043 108046 108047 108048 108051 108052 108053 108056 108057 108058 108061 108062 Diametrics Medical Inc Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Description of Test Establishes and checks a reference value on ISE2 to be used for comparison on next 4 tests Checks leakage between ISE2 and WKG1 3 and Heater Low Establishes and checks a reference value on ISE3 to be used for comparison on next 4 tests Checks leakage between ISE3 and WKG1 3 and Heater Low Establishes and checks a reference value on ISE4 to be used for comparison on next 4 tests Checks leakage between ISE4 and WKG1 3 and Heater Low Establishes and checks a reference value on ISES to
14. I 118001 118030 Compare each ISE channel against another ISE channel Also check Contaminated Edge Connector tion ISE1 against WKG1 These checks use data collected in phase 10 to Extremely high humidity verify that the ISE1 6 and WKG1 channels have the precision required Latent circuit failure for quality sensor data measurement 6 WKGI 118031 118050 Use data generated from the first half of phase 18 to perform differential Contaminated Edge Connector tion comparisons of the ISE1 6 channels This is identical to a sensor Extremely high humidity measurement where we perform a differential measurement between Latent circuit failure calibrant and blood This is the most precise testing we perform on the ISE channels Description of Possible Causes Contaminated Edge Connector All edge connectors are tested to rigorous specifications at 80 RH before they are used for new product or replacement this testing was implemented in spring 98 It is likely unlike a high humidity issue that once an edge connector is contaminated it cannot be recovered The most likely contaminants are aqueous fluid and blood but may also include plastic shavings from many thousands of cartridge insertions There is a chance that contamination could get onto the main board as well as the edge connector The most likely errors will occur in phase 8 if contamination has occurred Extremely High Humidity This should be understood as more than 80 relative hu
15. ING DIFF VALUES e Wet or contaminated Edge Connector clean and dry or replace e Malfunctioning cartridge e Invalid cartridge type for software installed in the IRMA Verify compatability 3001 BATTERY IS LOW ON POWER e Low Battery This is more of an indicator than an error 3201 AC POWER ADAPTER VOLTAGE HI e AC Adapter is not functioning properly output voltage is too high for IRMA replace AC Adapter 5002 IR TEMP OVERSHOT SETPOINT e Faulty IR probe which requires replacement 5003 IR CAL TIMEOUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Instrument not equilibrated to new environment 30 minutes is required Faulty IR probe which requires replacement IR SAMPLE TIMEOUT Wet or dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Faulty IR probe which requires replacement Diametrics Medical Inc Pg 41 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS 5006 IR TEMP OUT OF SPEC DURING SAMPLE 5007 pH CAL TIMEOUT 5008 pHSAMPLE TIMEOUT e 5009 CO2 CAL TIMEOUT 5010 CO2 SAMPLE TIMEOUT e e
16. ISE4 and other pins not WKG1 3 or Heater Low Checks for null leakage on ISE5 channel without generating a stimulus leakage current on other pins Checks leakage between ISES5 and other pins not WKG1 3 or Heater Low Checks for null leakage on ISE6 channel without generating a stimulus leakage current on other pins Checks leakage between ISE6 and other pins not WKG1 3 or Heater Low Checks for null leakage on ISEREF channel without generating a stimulus leakage current on other pins Checks leakage between ISEREF and other pins not WKG1 3 or Heater Low Establishes and checks a reference value on ISE1 to be used for comparison on next 4 tests Checks leakage between ISE1 and WKG1 3 and Heater Low POSSIBLE CAUSE Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE4 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE5 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE6 channel on main circuit board Latent circuit failure Contaminated
17. P N 463200 Rev 6 IRMA Support Manual Up to and Including Software Version 5 1 x Diametrics Medical Inc Pg 1 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use P N 463200 Rev 6 Table of Contents QUESTION amp ANSWER SECTION 55 1 7 1 p epis ori d dad bhagaus ean adc ede EE r Fe Sosas ae Pa siteet Sst SrO PER RE Noe V Md eae EET S RP TEDRR EAR A TE TRE RERU Era e o Tas TERN 3 TECHNICAL SEC TON tein triv di uxo saunivastes cosbaspsidusanedeuhestaassveatadsnseaspaesucnvuasuasesuasascateasyesesuswalisescsuuatedensbccusidveaaassvnes EN E FIN eee cDe RECO ME UR eNEE 9 TPRIVEASS OP PW ARE oro c TI 24 LIFESCAN c 24 APPENDIX A AQUEOUS QUALITY CONTROL issaasssassecesesssccsenisscstasseadassuahadscuisenlscaksesdsseusenssspuvsedscbatsaisssasevaseiasecasuss adenstisscatbases 25 APPENDIX B HOW TO ESTABLISH A QC RANGE dac eeetu boue pnus ko ees 3r Se Paac Fe eal lo Enos ues2u seas Fuge Ve Sa zr ru pna soe ota Cebu eo dps aaepe ton 26 APPENDIX C ELECTRONIC QUALITY CONTRO DL eee ee eee ense ee seen asse teen se sete aa ses seen ao ee een sese e aeos eee setae see een see seen ae 29 APPENDIX Di SYRINGE INFORMA TION ito li reeeetb eva yeasba Ve rroetan eine osinetan UE Va ances CERRAR Ae ELE eR OMEN e aa atoae a ead PUR ana 3
18. an and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5071 Na CAL mV TOO LOW e Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace e Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace e Malfunctioning cartridge Na CAL mV TOO HIGH Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge K INITIAL ROOM TEMP mV OUT Snap cap on applicable products deployed prematurely Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge K CAL mV TOO LOW Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Diametrics Medical Inc Pg 48 Note This is a controlled document All changes must be autho
19. be used for comparison on next 4 tests Checks leakage between ISES and WKG1 3 and Heater Low Establishes and checks a reference value on ISE6 to be used for comparison on next 4 tests Checks leakage between ISE6 and WKG1 3 and Heater Low Establishes and checks a reference value on ISEREF to be used for comparison on next 4 tests POSSIBLE CAUSE Extremely high humidity Contamination on ISE2 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE3 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE4 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE5 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISE6 channel on main circuit board Latent circuit failure Contaminated Edge Connector Extremely high humidity Contaminatio
20. cked MF1 4 Bias 112001 112022 Each bias circuit is individually checked to assure they can set the bias to e Latent circuit failure Function the correct voltage and source current In addition any associated switches a are tested HCT Circuit 115001 115024 The instrument s open circuit impedance is checked on all channels to Contaminated Edge Connector Function assure it has not changed since calibration Extremely high humidity Latent circuit failure HCT Circuit 116001 116048 The resistance measurement circuit is checked on all hematocrit channels Contaminated Edge Connector Function by measuring a known resistor or zero point Results are checked to Extremely high humidity assure they have not changed since calibration Latent circuit failure Diametrics Medical Inc Pg 36 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Test Type Error Codes Description of Test POSSIBLE CAUSE ISEI Drift ISEI Func ISEI Func 6 WKGI 117001 117015 Check for drift on ISE1 6 and WKGI channels We apply a reference Contaminated Edge Connector voltage current to the channels and measure them We then wait for Extremely high humidity about 30 seconds meanwhile we check other circuits then check them Latent circuit failure again to make sure they have not drifted Tests 1 7 are the initial checks tests 8 15 are the final checks 6 WKG
21. cument All changes must be authorized by DMI and revision controlled This document is not intended for customer use 8xxx Data Downloading messages and errors These can be anything from warnings to the user to download data from IRMAAZ to actual downloading errors The user should know if they were unable to download and at that point contact technical support Otherwise this message is a recording of the warning and should be ignored on the usage log IC Insertion Count is the number of cartridge insertions experienced by an IRMA This number is also printed on the Other Errors log to allow calculation of a total error rate experienced by a user To determine the number of insertions on an IRMA during a given time period simply subtract the first IC number from the last IC number for the time period of interest To determine the sensor error rate count the number of 5xxx errors on the usage log and calculate as follows 96 Sensor Errors 5xxx Errors Sensor Insertions 100 Diametrics Medical Inc Pg 58 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX H Medical Usefulness Criteria Health Care Financing Administration Evaluation Criteria CLIA Analyte Medical Usefulness Limits pH t 0 04 pH units 5 mmHg or 8 Whichever is greater 5 mmHg or 7 5 Whichever is greater t4mM 05 mM Ionized Calcium No g
22. d document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 45 Code ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS 5054 HCT PHASE 4 DATA OUT 5055 HCT PHASE 5 DATA OUT 5056 HCT PHASE 6 DATA OUT 5057 HCT PHASE 7 DATA OUT 5058 HCT PHASE 8 DATA OUT 5059 HCT PHASE 9 DATA OUT Diametrics Medical Inc Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or o
23. dge Glucose Amp 2 5th cal value too high Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 52 EMEN OMEN e Malfunctioning cartridge 5350 Glucose Amp 2 6th cal value too high Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5351 Glucose Amp 2 drift during calibration Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 6076 BP OUT HIGH Bad user barometer offset entered IRMA barometer malfunctioning replace barometer e IRMA malfunctioning get instrument for repair e IRMA malfunctioning get instrument for repair 6402 e IRMA malfunctioning get instrument for repair e IR ioni i i IR ioni i 6406 INVALID HW PARAMETERS MA malfunctioning ge
24. dge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge 5051 HCT PHASE 1 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge 5052 HCT PHASE 2 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge 5053 HCT PHASE 3 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Diametrics Medical Inc Pg Note This is a controlle
25. document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX F Temperature Test Error Codes Temperature Control Test Description Test Type General Description of Test Continuity 101101 These checks determine whether some of the Temp card pins are 101110 connected to the analyzer Each discrete check actually checks 2 pins The pins checked are REFI 3 ISE1 6 WKG1 3 ISEREF 101111 Check initial card temperature 101112 Checks IRMA instrument internal temperature Broken Edge Connector Pin Broken Edge Connector Flex Circuit Broken Temp card Contamination in edge connector raising impedance Note IRMA relies upon certain pins being intact in order to recognize that the card has been inserted and in order to identify the card Because of this a broken Temp card may not be detected or properly identified and therefore the test will not proceed The environment in which Temp Card is stored in is too hot 740 C or too cold lt 12C The environment in which the system is operating in is too hot gt 40 C or too cold lt 12C Broken temp measurement circuit The environment in which Irma is operating in is too hot gt 40 C or too cold 12C IRMA was recently within the past hour moved from an environment that is extremely low or high temperature Broken temp measurement circuit General Status 101113 Checks power into main PCB Input voltage t
26. e Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge Problem with Sample Cartridges not equilibrated Malfunctioning cartridge Problem with Sample Hole in cartridge foil pouch Cartridges not equilibrated Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 42 ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS e Malfunctioning cartridge 5019 pH result is less than 6 0 e Problem with Sample Cartridges not equilibrated Malfunctioning cartridge 5020 pH result is greater than 8 0 Problem with Sample Cartridges not equilibrated Malfunctioning cartridge 5022 FALSELY DETECTED CARD OUT O2 Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge FALSELY DETECTED CARD OUT HCT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge 5024 pH NOT RESPONDING QUICKLY CAL Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edg
27. e connector Clean and dry edge connector or replace Malfunctioning cartridge 5025 CO2 NOT RESPONDING QUICKLY CAL Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5026 PH SENSITIVITY FAILED CHECK 3 e Malfunctioning cartridge 5029 pH CORRECTION TOO LARGE e Malfunctioning cartridge 5030 pH SENSITIVITY FAILED CHECK 1 e Malfunctioning cartridge 5031 pH SENSITIVITY FAILED CHECK 72 e Malfunctioning cartridge e Possible high cartridge storage temperature e 5032 FALSELY DETECTED CARD OUT TEMP Dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Faulty IR probe which requires replacement 5034 K DRIFT AT INJECT OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5035 Na DRIFT AT INJECT OUT e Incomplete cartridge connection to edge connector Possible cartridge lead problem Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended
28. e not removing air bubble from High syringe prior to injection debo air Are results out high or Using proper injection technique contamination low Equilibrated cartridges Low e Gel contamination Diametrics Medical Inc Pg 17 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use WHOLE BLOOD RESULTS Yes pH results are not what was A expected or did not compare cy Monir ees ars p Confirm sample has been to a reference equilibrated mixed appropriately Yes Are results greater than 0 04 away Equilibrate cartridges Mix sample according to NCCLS guidelines Improper mixing can cause a pH result to be off as much as 0 11 pH units ina stable environment for a minimum of 72 hours from expected result Meets Performance Specifications Suspect Cartridges are not equilibrated Sample is not mixed appropriately Something wrong with reference analyzer Diametrics Medical Inc Pg 18 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use pCO2 results are not what was expected or did not compare to a reference Diametrics Medical Inc Yes Confirm cartridges are gt Are results greater than 5 equilibrated mmHg from the expected result Eq
29. e than 8 C DMI recommends that both IRMA and cartridges be stored in a stable temperature environment off the alternate site location IRMA and an appropriate number of cartridges should be taken from the storage site when testing in an alternate site is required Cartridges that are not used during a testing event e g an ambulance run must go through the 72 hour equilibration time before being put back into use unless the site can verify that temperature fluctuations did not exceed 8 C of the room temperature storage area Verification is possible if cartridges are transported and stored in an IRMA carrying case that contains a high low thermometer Where should quality control be performed EQC can be performed on the analyzers in the storage area or in the alternate site AQC should be performed on the cartridges in the storage area prior to placement in the alternate site Calibration How does IRMA calibrate IRMA performs a modified two point calibration The sensors are calibrated prior to each test using a pre packaged calibrant over the sensors The calibrant is manufactured and tested with NIST traceable gases and salt standards Calibration of the cartridge is completed when information determined at the factory for each lot of cartridges the Cal Code is combined with measurements taken during the calibration process The factory derived Cal Code information is stored in the analyzer memory
30. e thermistor is disconnected Latent IR probe circuit damage Incorrect Calibration Code Entered See 109101 if this value is lt 103600 or gt 103800 Pg 40 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX G Usage Log Error Codes Usage Log ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS 1003 INSTRUMENT TEMP OUT HIGH e The environment in which IRMA is operating in is too hot 240 C e Faulty IR probe which requires replacement 1004 INSTRUMENT TEMP OUT LOW e The environment in which IRMA is operating in is too cold gt 12 C e Faulty IR probe which requires replacement 1005 IR PROBE TEMP CARD OUT HIGH e Customer is re inserting a cartridge that was in the analyzer and therefore was already heated above the acceptable limit e The cartridge storage environment is greater than 30 C e Faulty IR probe which requires replacement e The cartridge storage environment is less than 12 C e Faulty IR probe which requires replacement e Cartridge removed prematurely User error repeat in service e Time to deploy cap expired User error repeat in service 2006 TEST BUTTON PRESSED TOO LATE e Time from injection to test button push too long User error repeat in service 2007 NO INJECTION PERFORMED e Injection not performed and test button pushed User error repeat in service 2100 CARD ID OBTAIN
31. els on main circuit board Latent circuit failure Leakage 108005 Checks for null leakage on ISE2 channel without generating a stimulus Extremely high humidity leakage current on other pins Contamination on ISE2 channel on main circuit board Latent circuit failure Leakage 108006 Checks leakage between ISE2 and other pins not WKG1 3 or Heater Contaminated Edge Connector Low Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Leakage 108007 Checks for null leakage on ISE3 channel without generating a stimulus Extremely high humidity leakage current on other pins Contamination on ISE3 channel on main circuit board Latent circuit failure Diametrics Medical Inc Pg 32 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Test Type Error Codes 108008 108009 108010 1080011 108013 108014 108015 108018 108019 108020 108024 108025 108026 108031 108032 108033 108036 Diametrics Medical Inc Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Description of Test Checks leakage between ISE3 and other pins not WKG1 3 or Heater Low Checks for null leakage on ISE4 channel without generating a stimulus leakage current on other pins Checks leakage between
32. ensor errors or EQC errors EQC and Temperature test errors The other errors log is a printable record of all messages given to the user during testing on the IRMA Blood Analysis System These messages include sensor errors low battery messages data downloading warnings instrument errors environmental warnings and user induced procedural errors This log is a troubleshooting tool and is not intended for customer use The following is a list of general error code classifications that stay consistent between software versions Whenever possible the specific IRMA error code numbers are kept the same between different software revisions to avoid confusion 1xxx Environmental condition errors Either the IRMAA or the cartridge is outside acceptable operating conditions 2xxx User procedural errors These errors include procedural problems such as premature removal of the cartridge failure to perform some action within the allowed time period or insertion of an incorrect card type 3xxx Low battery and AC adapter messages 4xxx Software upgrade notes and factory default messages 5xxx Sensor errors If the user is experiencing an undiagnosed occurrence of 1096 of this type of error code DMI technical support should be contacted 6xxx Instrument and software errors These are usually unrecoverable and DMI technical support should be contacted 7xxx Not used at this time Diametrics Medical Inc Pg 57 Note This is a controlled do
33. examples of frictionless syringes that are incompatible with the IRMA system without the use of a check valve e Concord Pulsator Arterial Blood Sampling Kit e Bard Parker Liquihep Kit e Bard Parker Dri Hep 3cc looks like 5cc but only holds 3cc 2 Syringes that contain a mixing ball or non dissolving disk impregnated with heparin Due to the vertical orientation of the syringe during injection the ball or disk may become lodged in the bottom of the syringe and the sample may hemolyze when it is forced through or around the plug during injection The following syringe is incompatible with the IRMA system e Radiometer QS 50 Arterial Blood Sampler 3 Incompatible Hub e The Bard Parker Safety Lock syringe has a large hub that does not fit into the luer port of the IRMA cartridge The compatibility of a syringe that is not listed can be determined by evaluating it in terms of the aforementioned characteristics Please forward any syringes that you would like to have formally evaluated to Diametrics Technical Support Diametrics Medical Inc Pg 31 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX E Internal EQC Error Codes Internal EQC Test Description Test Type Description of Test POSSIBLE CAUSE General Status 101001 Checks IRMA instrument internal temperature e The environment in which Irma is operating in is too hot 740 C
34. following initial entry of a new cartridge lot Diametrics Medical Inc Pg 7 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Proficiencies What proficiencies programs are recommended for use on IRMA Appendix I What are the proficiency testing requirements for CAP If your customer is CAP certified they must participate in the CAP surveys Sometime during the year they must perform a CAP survey on every IRMA they have CAP does not accept the idea of proving instrument comparability by running a survey on a primary instrument and split sampling on the rest CLIA does accept this CAP has stated that it is acceptable to split surveys amongst multiple analyzers so those customers are not required to purchase a separate survey for each IRMA EXAMPLE A customer has 30 IRMA s They order 1 blood gas proficiency AQ survey They receive this survey three times a year Each survey has at least five levels plus at least five duplicates therefore ten proficiency samples They receive their first survey in January Since they have ten samples they analyze one on each of ten analyzers THEY RECORD EVERYTHING AND KEEP RECORDS OF THE TESTING They receive their next survey in June with ten more samples They run these on ten DIFFERENT IRMAs Ditto for the next survey received in November If they keep good records they ca
35. for customer use 43 ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge Malfunctioning cartridge 5036 Na CAL TIMEOUT Incomplete cartridge connection to edge connector Possible cartridge lead problem iui MEM or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge e Malfunctioning cartridge 5038 Ca CAL TIMEOUT Incomplete cartridge connection to edge connector Possible cartridge lead problem To or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge 5039 Ca SAMPLE TIMEOUT e Problem with Sample Malfunctioning cartridge EDTA anti coagulant used on sample 5040 K CAL TIMEOUT Incomplete cartridge connection to edge connector Possible cartridge lead problem ee or edge connector problem Clean and dry edge connector or replace Malfunctioning cartridge us e Malfunctioning cartridge e Malfunctioning cartridge 5043 K WARMUP FAIL e Moisture on edge connector possibly caused by water droplets on the lead tape prior to removal Dry edge connector or replace Instruct customer on the potential cause of this error and ask them to dry the lead tape prior to removal if moisture is observed Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector
36. ge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge HCT PHASE 11 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge HCT PHASE 12 DATA OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge CONDUCTANCE RATIOS NOT SIMILAR Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge CONDUCTANCE DRIFT TIMEOUT Wet or dirty IR probe Clean and dry the probe Obstructed or rece
37. gulator failure 5101 BUN INTIAL ROOM TEMP mV OUT Diametrics Medical Inc Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 49 5102 BUN CAL mV TOO LOW Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5103 BUN CAL mV TOO HIGH Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5104 BUN DRIFT AT INJECT OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace e Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace e Malfunctioning cartridge pum e Malfunctioning cartridge BUN IN
38. ination of extended higher humidity and time Many contaminants are benign until moisture is added to the mix As a result it may appear as though an extremely high humidity situation has occurred phase 8 errors but the problem is more impervious to the normal drying out solution discussed in the High Humidity section NOTE REGARDING LEAKAGE FAILURES Leakage current is additive In other words one failure mode alone may not cause the error to occur Sometimes it is the combination of contamination and high humidity that causes a failure to occur Diametrics Medical Inc Pg 37 N ote This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use e Latent Circuit Failure The circuit under test worked well at one time For some reason it no longer functions the same This could be due to many reasons Mechanical failure such as a broken solder joint may result from dropping or banging There is a possibility that ESD damage may occur while an edge connector is being changed since the ESD protection is in the edge connector and without it damage to the main PCB is possible Internal EQC does not check Cartridge Failures Barometric Pressure Measurement Battery or AC Adapter Failures except where noted Any failure that prevents power on Heater control circuit Continuity through edge connector Diametrics Medical Inc Pg 38 Note This is a controlled
39. l determinations should fall within 2 standard deviations of the mean value Approximately 99 7 of all determinations should fall within 3 standard deviations of the mean value Laboratories commonly set control limits at either two or three standard deviations If two standard deviations are chosen the laboratory can predict that under these conditions only one out of 20 determinations will exceed the limits because of chance If a second result exceeds two standard deviations it is then suspect of not meeting the conditions originally used in determining the mean If a result exceeds three standard deviations this result is genuinely suspect since this could occur by chance only three times in one thousand 6 Assign tentative range based on the following Range Limits pH Mean 0 03 for all 3 levels pCO2 mmHg Mean 8 for level 1 Mean 5 for levels 2 and 3 pO2 mmHg Mean 10 for all 3 levels Na mM Mean 5 for all 3 levels K mM Mean 0 5 for all 3 levels iCa mM Mean 0 1 for all 3 levels units in mM Het Pcv Mean 3 Cl mM Mean 5 for all 3 levels BUN mg dL Mean 6 for level 1 5 for level 2 3 for level 3 or T Follow the normal protocol for your facility for handling data Due to the small number of observations initial Quality Control limits should be established using the range limits above Once the facility has approximately 100 points the plus or minus 2 to 3 standard deviati
40. lucose Amp 1 Ratio Check 1 5330 Glucose Amp 1 Ratio Check 2 Problem with Sample Malfunctioning cartridge Problem with Sample Malfunctioning cartridge 5331 Glucose Amp 1 Ratio Check 3 e Problem with Sample e Malfunctioning cartridge 5332 Glucose Amp 1 Ratio Check 4 e Problem with Sample e Malfunctioning cartridge 5333 Sample Amp 2 Drift too negative e Problem with Sample e Malfunctioning cartridge e Malfunctioning cartridge 5335 Amp2 CR 1 and 2 Don t Match at High Level e Problem with Sample e Malfunctioning cartridge 5336 Amp2 CR 2 and 3 Don t Match 5337 Amp2 Glucose out of Range High 5338 Amp2 Glucose out of Range Low e Malfunctioning cartridge e Problem with Sample e Malfunctioning cartridge Problem with Sample Malfunctioning cartridge 5339 Glucose Amp 2 Ratio Check 1 Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 51 ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS e Malfunctioning cartridge 5340 Glucose Amp 2 Ratio Check 2 e Problem with Sample e Malfunctioning cartridge e Malfunctioning cartridge e Malfunctioning cartridge e 5343 Glucose Amp 1 and Amp 2 results different Problem with Sample e Malfunctioning cartridge Glucose Amp 1 4th cal value too high Incomplete cartridge connection to edge connector Possible car
41. midity IRMA can withstand higher humidity but it should not be expected to perform ideally until it has had a chance to dry out A special condition may occur besides high humidity that is worth discussing Particularly users may not understand that even though they may be in a dry environment large quick changes in temperature from cold to hot will cause condensation on both the inside and outside of IRMA Condensation is particularly tough to solve Since air transfer occurs very slowly from inside to outside of IRMA it takes a long time to get the moisture out of IRMA The best solution is to turn IRMA on for several hours to aid in the drying out process An EQC error due to humidity should always fix itself given a lower humidity environment high humidity most likely will not cause permanent damage to IRMA If the user has allowed plenty of drying time in less humid conditions and the EQC errors continue it is likely the errors are not due to high humidity Although high humidity could be the cause of failure for most phases phase 8 will likely be the first to indicate the RH is too high Contamination between Channels on Main PCB This will most likely be due to contamination that was on the main board from the manufacturing process Often contamination from assembly of the board requires an activation means This could be simply the passage of time Slight contamination can become conductive over time It would more likely be a comb
42. ming tests instructions for reporting results calibration procedures quality control procedures and requirements and protocol for remedial actions Not required Required every six months IRMA does this before every test Proficiency Testing Participate in program that meets Must participate in CAP survey Participate in program that meets federal and state regulations federal and state regulations Required for medicare In Inspections s Diametrics Medical Inc Every two years Every two years Every two years Pg 61 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use
43. n between channels on main circuit board Latent circuit failure Extremely high humidity Contamination on ISEREF channel on main circuit board Latent circuit failure Pg 34 Test Type Error Codes 108063 108066 108067 108068 108069 108070 108071 108072 Diametrics Medical Inc Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Description of Test Checks leakage between ISEREF and WKG1 3 and Heater Low Checks for null leakage on WKGI channel without generating a stimulus leakage current on other pins Checks leakage between WKGI and other pins Checks for null leakage on WKG2 channel without generating a stimulus leakage current on other pins Checks leakage between WKG2 and other pins Checks for null leakage on WKG3 channel without generating a stimulus leakage current on other pins Checks leakage between WKG3 and other pins Checks leakage from MF1 multifunction 1 pin to other MF pins reference pins heater hi and heater low Checks leakage from MF2 multifunction 2 pin to other MF pins reference pins heater hi and heater low Checks leakage from MF3 multifunction 3 pin to other MF pins reference pins heater hi and heater low POSSIBLE CAUSE Contaminated Edge Connector Extremely high humidity Contamination between channels on main circuit board Latent circuit failure Extremely
44. n show CAP during their inspection that they have analyzed a proficiency sample on each of their IRMAs Regulatory How do CAP CLIA and JHACO rules and regulations compare Appendix J Diametrics Medical Inc Pg 8 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Technical Section IRMA FAILURE 7 No gt Have customer run EQC again Did EQC pass May Yes omit step This is not a hardware failure This is not a hardware failure Diametrics Medical Inc Have customer read EQC error codes from last failure Refer to Appendix E for error code meaning Take appropriate action P N 463200 Rev 6 Pg 9 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use BATTERY FAILURE Have customer turn IRMA on From Yes Is battery the main menu press Recall BUT QUEM Status Battery This will bring up old the battery status screen Can customer do this This is not a battery failure H h b Battery is at the end of its use aye customer recat ge gartery life Customer should for 24 hours remove battery For Errors 4 5 and 6 Have from charger and re insert into customer recharge battery for 24 charger for another charge cycle hours remove battery from charger and re inser
45. nsor circuits ampometric potentiometric and conductometric Each type of sensor operates over a fixed range of sensor responses These responses must be measured within certain specifications throughout that range in order to give consistent results Temperature Control System IRMA s temperature control system maintains a sample at body temperature during a blood gas test The temperature controller uses input from the infrared probe to turn the heater on and off to control sample temperature The heater is located on the cartridge IRMA s Temperature Test checks this system with the card being heated and controlled exactly as a blood gas cartridge would be The temperature 1s measured in the Temperature card and compared with expected results 37 C 0 6 C Diametrics Medical Inc Pg 30 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX D Syringe Information Incompatible ABG Syringes In general there are three primary types of ABG syringes that are incompatible with the IRMA system 1 Frictionless pulsating syringes after sample injection the hub of the syringe will continue to travel downwards by itself until all the sample has flowed into the cartridge The analyzer is unable to heat the sample adequately as it slowly continues to move through the sample path and the test results in a sensor error The following are
46. ntrolled This document is not intended for customer use Test Type General Description of Test Possible Causes Temp Control 109101 Result Temp Control 10XXXX Result Last Error Code Only Most often this will be the only temperature failure test even though all the phase 5 tests pass This check takes the phase 5 data and the calibration code and calculates the final temperature result There is only one error for the temperature check indicating that the temperature is outside the 36 to 38 degree C range The control temperature of the last passed Temperature Test can be seen by going to the About screen Passing TT means passing temperature test A 4 digit number represents the xx xx degrees C Also listed is the date and time the that last passing temperature test occurred In the Temperature Test Errors section the final code for any test is the control temperature The code is decoded as follows e g 103556 is read as 35 56 degrees C Temperature Control Test does not check Cartridge Failures Diametrics Medical Inc Barometric Pressure Measurement Battery or AC Adapter Failures except where noted Failures that prevent detection of inserted card Any failure that prevents power on IRMA Analyzer functions checked in the Internal EQC test IR Probe Blocked or dirty Temp Card not fully inserted IR Probe Misaligned due to shock Temp card damaged such that theIR probe window on back blocked or th
47. of the SSP module Error generated by Lifescan SW Replace module e Glucose Par Up Contact No strip Glucose strip removed before test could complete Glucose strip contacts are dirty Internal failure of the SSP module Error generated by Lifescan SW Replace module Glucose Contact No strip Glucose strip removed before test could complete Glucose strip contacts are dirty Internal failure of the SSP module Error generated by Lifescan SW Replace module Glucose Open Contact w Strip in Black tip of Glucose strip is damaged Glucose strip contacts are dirty Internal failure of the SSP module Error generated by Lifescan SW Replace module 38 Glucose Power Fail Internal failure of the SSP module Error generated by Lifescan SW Replace module 39 Glucose Watchdog Fail Internal failure of the SSP module Error generated by Lifescan SW Replace module 5 Glucose Reserved 5 45 Glucose Temp Fluctuation Internal failure of the SSP module Error generated by Lifescan SW Replace module 46 Glucose Reserved 6 N A aT Glucose Reserved 7 Glucose Reserved 4 A Usage Log Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 56 Recalling the Error Logs these steps print the a log IE 2 3 4 Power IRMA on Select RECALL Select LOGS Select other errors instrument procedural and s
48. oftware loading attempt software load again e IRMA malfunctioning get instrument for repair e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair e I ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 6513 e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 6514 e I ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 6515 SYSTEM CLOCK READ FAIL e I ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 6516 UNEXPECTED INTERRUPT IRMA malfunctioning get instrument for repair 6520 UNABLE TO READ HW CONFIGURATION If error is associated with software loading attempt software load again If error is associated with software loading attempt software load again IRMA malfunctioning get instrument for repair If error is associated with software loading attempt software load again IRMA malfunctioning get instrument for repair IRMA malfunctioning get instrument for repair If error is associated with software loading attempt software load again IRMA malfunc
49. on limits may be used am Data should be reviewed monthly after the range is established to verify that the range is still representative of conditions originally used in determining the mean Acceptance and rejection criteria for daily quality control These are only suggestions As a user you may choose to follow the normal protocol established by your facility for the acceptance or rejection of daily quality control values Diametrics Medical Inc Pg 27 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 1 If values are within range the system is ready for patient testing 2 If a value is outside of range do the following a Have user check for the following Verify QC lot being tested is the same as the one for which the range is established Verify that sample integrity is acceptable i e no air bubbles in flow path or that opened sample has not been exposed to room air for longer than necessary Be sure to record any observations or actions taken in action log b Have the same operator repeat testing with another ampule of control This will help determine whether sample handling by an individual operator is a possible source of error If repeat is within range the system is ready for patient testing Be sure to record any actions taken in action log c If value is still outside of range have a different operator repeat
50. oo high Above 10V AC Adapter Failure Broken measurement circuit Broken Edge Connector Pin Broken Edge Connector Flex Circuit Broken Temp card Contamination in edge connector raising impedance AC Generator Circuit Failure Impedance Measurement Circuit Failure Note If either the Heater High or the Heater Low pins are completely open the card will not even be recognized as Continuity 103101 These checks determine whether some of the Temp card pins are 103109 connected to the analyzer We don t just check for connection but for a certain maximum allowed impedance Each discrete check actually checks 2 pins We use the impedance Hct measurement circuit for these checks The pins checked are MFI 4 Heater High Heater Low Temp Control 105101 The heater is the same as on any cartridge but a thermistor is located Data 105103 in place ofthe sensors The Temp Card is heated and controlled exactly as any cartridge The temperatureis measured via the thermistor and compared with expected results These tests collect preliminary data for the final thermistor check inserted IR Probe Blocked or dirty Temp Card not fully inserted IR Probe Misaligned due to shock Temp card damaged such that theIR probe window on back blocked or the thermistor is disconnected Latent IR probe circuit damage Diametrics Medical Inc Pg 39 Note This is a controlled document All changes must be authorized by DMI and revision co
51. oom temperature for one hour with IV solution Confirm anticoagulant prior to use was used Confirm correct anticoagulant was used Inspect pathway for presence of air bubble or gel Diametrics Medical Inc Pg 21 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Hematocrit results were not what was expected or did not compare to reference Confirm that there 1s no white blood cell interference Confirm that there 1s no protein interference CBP patients may need correlation line for this analyte Confirm that the reference is measuring hematocrit Confirm that the reference sample was also mixed according to NCCLS guidelines Diametrics Medical Inc Confirm that sample was mixed appropriately according to NCCLS guidelines Is result within 2 PCV or 6 of the expected result Result is within performance specifications NCCLS guidelines dictates that a sample that is to be tested for hematocrit be mixed for a minimum of two to four minutes especially if the sample has been iced Pg 22 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use IDMS Corrupted Database Runtime Errors and General Protection Faults Double Click on My Computer gt C or the drive where IDMS is sto
52. oss its operating Contaminated Edge Connector range Extremely high humidity Latent circuit failure General Status 110001 Checks VREF voltage This is the reference voltage we use for our e Extremely high humidity analog to digital conversion of sensor channel data It needs to be stable e Latent circuit failure ISE1 6 WKGI 110002 110029 Applies 5 different potentials independently to all 6 ISE channels and 5 Contaminated Edge Connector Function different current levels for WKGl This stimulus verifies the function of Extremely high humidity these channels over their entire range We use this as a screening check Latent circuit failure to make sure the channels are working pretty good Phase 18 checks these channels more thoroughly ISE1 6 WKGI 110031 110066 Apply 5 different voltages to all 6 ISE channels current for WKG1 Contaminated Edge Connector Function This stimulus is over a relatively small signal range We will use this Extremely high humidity data for phase 18 comparison tests Latent circuit failure WKGI 110067 Check the input switch into WKGI circuit small current e Latent circuit failure Function 110068 Check a circuit called I MON This circuit is not used now but may be someday WKG2 3 111001 111012 Check WKG2 3 for proper operation by providing stimulus current to e Extremely high humidity Function each Three ranges are applied The input switches to these circuits are e Latent circuit failure also che
53. points that are more than three standard deviations from the regression line Replace them with data acquired from additional split sample analyses and re determine the regression line What are the issues with hematocrit in the CVOR IRMA uses conductivity to measure hematocrit While on cardiopulmonary bypass several components of the blood may experience changes either due to interferences or as a result of hemodilution A complete discussion and protocol for CVOR and hematocrit measurements Corrrecting Conductive Hematocrit Results for Hemodilution During Cardiopulmonary Bypass is available from Agilent How is the correlation feature activated Refer to Section 7 of the IRMA User Manual Diametrics Medical Inc Pg 6 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Alternate Site Can IRMA be used in a transport airplane helicopter ambulance or non hospital setting Yes IRMA may be used in any setting as long as environmental conditions i e temperature BP humidity do not exceed IRMA specifications Can IRMA and cartridges be stored in the alternate site No IRMA needs to be stored in a temperature range of 15 30 C Most alternate site locations cannot accommodate this The cartridges need to be stored within a STABLE temperature range of 15 30 C that does not fluctuate mor
54. r 15 30 C 59 86 F What is the humidity range for IRMA 0 80 relative humidity How is IRMA s software upgraded Software updates are performed by connecting IRMA s RJ45 serial port on IRMA it is labeled computer port to a PC s serial com port The updated software is loaded onto the PC from a floppy disk provided by DMI The software is then uploaded to IRMA from the PC through the serial connection Evaluations Where is the best location to place IRMA IRMA should be set up next to the reference analyzer to minimize any time delay between sample analysis on the two instruments and to insure that the sample is treated the same for both analyzers What is the best sample type to use on IRMA Whole blood collected in a lithium heparin or balanced heparin syringe Who should perform the evaluation Laboratory personnel who have been properly trained on IRMA and are familiar with the reference analyzers What type of quality control program should be used during the evaluation Use the quality control program established in the institution for the reference analyzers For IRMA use both Electronic Quality Control EQC and Aqueous Quality Control AQC The purpose of this is to familiarize testing personnel with the use of aqueous quality control material on IRMA and to validate the EQC system Does anticoagulant need to be used DMI recommends the use of anticoagulant on samples used on IRMA What
55. reaker Slowly draw the control sample into a 1 mL or 3 mL syringe using an 18 20 gauge needle or dispense tip Do not attempt to invert the syringe or expel bubbles from the syringe after drawing up the control solution Remove the needle remove the cartridge cap and inject the control into the cartridge Use a minimum of 0 8 mL of the control sample in a 1 0 mL syringe or a minimum of 1 5 mL of the control sample in a 3 0 mL syringe Press test to initiate the analysis Use the expected values for each parameter as a guide in evaluating performance Since performance is subject to sample temperature Diametrics Medical recommendis that each institution establish its own expected values and acceptable limits The mean values established at your institution should fall within the expected ranges Diametrics Medical Inc Pg 25 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX B How to Establish a QC Range The following method for establishing tentative QC ranges is recommended for the IRMA SL Blood Analysis System Test Method I Testing should be conducted by multiple users to address any sample handling variations between different operators 1 e falsely warming up the sample while shaking the ampule or analyzing a sample that was opened too long before analysis 2 The initial analysis should be performed at the site
56. red gt IDMS Then single click on IDMS MDB From File on the toolbar cursor down and click on Rename Change the name to IDMSBAD MDB Login to IDMS Double Click on My Computer gt C or the drive where IDMS is stored gt IDMS Then single click on IDMS MDB From File on the toolbar cursor down and click on Rename Change the name to IDMSBAD MDB Login to IDMS Resend from IRMA Reboot computer Database will probably be corrupted Double Click on My Computer gt C or the drive where IDMS is stored gt IDMS Then single click on IDMS MDB From File on the toolbar cursor down and click on Rename Change the name to IDMSBAD MDB Login to IDMS If necessary refer to the IDMS troubleshooting guide for further help Diametrics Medical Inc Pg 23 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use IRMA SOFTWARE Upgrade failure LIFESCAN Reboot computer Go through the steps with the customer Send new disks Request they use a different computer Modem failure gt Request that the customer performs the following check e From the Main Menu press Recall Diametrics Medical Inc Press Status Press About Look to see if the LFS SN line is filled in If it is IRMA and the module are communicating and this is not a failure If the line is blank no communication is occurring and module should
57. rials that contain physiological levels of electrolytes may work with the IRMA system but customers will be required to establish their own ranges Philips DMI Technical Support can only provide limited AQC support on non RNA controls IRMA Quality Control ranges for all RNA Medical quality How do I obtain Aqueous Quality Control Ranges control material are available on the DMI website at http www diametrics com RNA QC and Linearity htm Ranges can also be obtained by contacting the Philips Response Center or DMI Technical Support How should aqueous quality control material be handled Follow the instructions provided with the DMI quality control ranges You can view these on the DMI website at http www diametrics com RNA QC and Linearity htm See Appendix A How should the aqueous quality control material be stored RNA QC materials do not require refrigeration Follow manufacturer s recommendation for storage If material is refrigerated allow material to warm to room temperature for a minimum of four hours prior to use How is a quality control range determined Follow instructions provided by DMI See Appendix B What is Electronic Quality Control See Appendix C IRMA Hardware Battery How long will the batteries last NiMH batteries will allow 30 40 tests depending on the features activated and how many printouts are required How long does the battery take to charge
58. ridges are required to go through an additional equilibration period due to temperature fluctuations of greater than 8 C in the cartridge storage area e Ifthe cartridges are required to go through an additional equilibration period run two levels of aqueous control before putting the cartridge lot back into use Run a Temperature Test e Monthly to verify that the IRMA temperature control system is operating properly The electronic checks span the measurement range of the device for each analyte In order to assess accuracy acceptability performance is checked at three distinct points for each analyte Diametrics Medical Inc Pg 29 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Edge Connector IRMA relies on consistent connections between the instrument and the cartridge These connections are made through the edge connector Once the EQC test is initiated all connection pins are tested individually to assure contact Internal Electronics Any contamination between sensor circuits can cause erroneous results During the Electronic Quality Control test leakage current is checked in the sensor circuitry Leakage current is unwanted current that flows through a circuit because of an unwanted short This circuit is used throughout the system to measure any possible leakage current Analyte Circuitry Our system includes three basic types of se
59. rity Determine Correlation coefficient Graph all analytes tested using linear regression Sample Handling Whole Blood What type of syringe should be used for sample collection Most arterial lithium heparin syringes may be used on IRMA See Appendix D for complete list and limitations What syringe size should be used on IRMA Diametrics recommends a 1 or 3cc syringe for use on IRMA For sample volumes 400uL DMI recommends use of 1cc syringes What is the sample mixing recommendation for samples analyzed on IRMA In order to avoid pre analytical error on samples analyzed for pH ionized calcium and hematocrit the sample should be adequately mixed we suggest rolling between your palms A sample that has been placed in an ice slurry should be mixed for a minimum of 2 minutes prior to injection into IRMA NCCLS recommendation A sample that has been drawn from a patient and will be immediately injected into IRMA still needs to be mixed Recommend 30 seconds Diametrics Medical Inc Pg 5 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use What is the proper injection technique for whole blood into the IRMA analyzer Inject the sample by depressing the syringe plunger in a single quick controlled motion similar to the motion used to press a stopwatch button Initially some resistance
60. rized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS e Malfunctioning cartridge 5075 KCAL mV TOO HIGH 5080 CONDUCTANCE RATIO FAILURE 72 Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge 5089 Final Na result less than 50 e Problem with Sample ld RN ry 5091 Final K result less than 0 5 e Problem with Sample ie ist OMNEM 5093 Final iCa result less than 0 2 mM 0 4 mEq L 0 8 mg dL EDTA used as an anticoagulant Problem with Sample Malfunctioning cartridge 5094 Final iCa result greater than 10 mM 20 mEq L 40 08 mg dL Problem with Sample Malfunctioning cartridge 5095 Final Hct result is Negative 5096 Final Hct result is greater than 80 e e Malfunctioning cartridge e Malfunctioning cartridge e 5097 ALL REQUIRED VALUES SUPPRESSED Problem with Sample e Malfunctioning cartridge 5098 Noisy 5 Volt Regulator 5V regulator failure 5099 Noisy 5 Volt Regulator e 5V re
61. ror Logs and Usage This will print out the last 50 messages IRMA has given the user Locate all errors starting with 5xxx These are the sensor errors Refer to Appendix G for a list of sensor errors and their possible causes Take appropriate action If error rate is over 10 notify DMI with lot number and copy of usage log Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 13 AQUEOUS QUALITY CONTROL pH results are out of range Have results been running high for a while Consider establishing a new range for this analyte Diametrics Medical Inc Confirm that the customer is using Confirm customer is 3cc or 1cc syringe using appropriate ranges 18 20 gauge needle for their QC lot and All users are using the same syringe size and IRMA software version needle size Injecting 1 5cc from a 3cc syringe or 0 8cc from a 1cc syringe All users are not removing air bubble from syringe prior to injection Using proper injection technique Equilibrated cartridges Are results out high or low Have results been running low for a while Has there been a temperature shift As temperature goes up pH goes up As temperature goes down pH goes down Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer
62. sors during a cartridge test Signals corresponding to both low and high analyte concentrations are tested and results must fall within strict predetermined thresholds for the test to pass IRMA EQC is an internal method and does not require the use of an external EQC card Temperature Test The IRMA temperature control system is tested at 37 C using the IRMA temperature card Diametrics Quality Control Recommendation Following method verification and establishment of aqueous quality control limits Diametrics Medical Inc DMI recommends EQC as the primary method of assessing system accuracy and precision Since each test site may have unique requirements each site should select and verify a quality control system that meets their needs DMI recommends the quality control be performed as follows Run an EQC test e Once per shift of patient testing on each analyzer e When the analyzer experiences a significant change in storage temperature ie movement from a cold to a hot or hot to a cold environment e Whenever the performance of the analyzer requires verification according to facility or regulatory agency protocol Run two levels of Aqueous Control e Before a new cartridge lot or shipment is put into use following the required equilibration period to verify proper shipping and equilibration conditions Cartridge lot verification 1s not required for each analyzer in use Additional Aqueous Control testing e Is required only if cart
63. ssed IR probe Verify probe is flush with the surface Faulty IR probe which requires replacement Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Diametrics Medical Inc Pg 47 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS e Malfunctioning cartridge 5066 TEMP COEFFICIENT CHECK IS OUT LOW Wet or dirty IR probe Clean and dry the probe Obstructed or recessed IR probe Verify probe is flush with the surface Faulty IR probe which requires replacement Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Malfunctioning cartridge 5067 TEMP COEFFICIENT CHECK IS OUT HIGH Wet or dirty IR probe Clean and dry the probe Faulty IR probe which requires replacement Malfunctioning cartridge 5070 Na INITIAL ROOM TEMP mV OUT Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Cle
64. t Record remedial actions Maintain records Electronic QC ok Procedural manual Covers policy and procedures training requirements specimen collection and preservation instrument calibration quality control and remedial action equipment performance and evaluations test performance Quality Assurance Linearity Linearity checks not required Evaluate per analyzer upon introduction of new method Calibration Verification Follow manufacturers guidelines Responsible individuals identified Evidence of specific training with quarterly competency checks Minimum high school diploma or equivalent List of authorized personnel BG two per 8 hrs of testing Lytes two per 24 hrs of testing Hct two per 8 hr shift Record remedial action Maintain records Electronic QC OK Procedural manual available in each area of testing Manual contains specimen collection and preservation instrument calibration quality control and remedial action test performance and maintenance records Required at a minimum every six months IRMA does this before every test HCFA CLIA Responsible individuals identified Evidence of specific training with quarterly competency checks Minimum high school diploma or equivalent BG one per 8 hr shift or 2 per 24 hrs of testing whichever is greater Lytes 2 per 24 hrs of testing Hct two per 8 hr shift Electronic QC ok Procedural manual containing instructions for perfor
65. t instrument for repair 6407 HW CONFIG BITS 0 e MA malfunctioning get instrument for repair 6500 SW UPLOAD CRC FAIL IN RAM BOOTLOADER If error is associated with software loading attempt software load again e e IRMA malfunctioning get instrument for repair 6501 SW UPLOAD CRC FAIL IN FLASH BOOTLOADER e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair R 6502 FLASH HEADER CHECKSUM FAIL BOOTLOADER e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 6503 NOVRAM VERSION MISMATCH BOOTLOADER If error is associated with software loading attempt software load again Lithium battery requires replacement IRMA malfunctioning get instrument for repair 6504 BAD CRC OF NOVRAM IMAGE If error is associated with software loading attempt software load again IRMA malfunctioning get instrument for repair Diametrics Medical Inc Pg 53 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use e IRMA malfunctioning get instrument for repair e IRMA malfunctioning get instrument for repair e IRMA malfunctioning get instrument for repair 6508 e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair e ferror is associated with s
66. t into charger for another charge cycle purchase new battery For errors 2 and 3 Battery is out Battery is fine Customer of temperature range Let may be having problems Is LMD greater batteries sit at room temperature with a different battery at than 2000 NIMH for one hour Then recharge site Run all batteries or greater than battery for 24 hours remove through this flow chart 1000 NICAD battery from charger and re insert into charger for another charge cycle Battery may be past its use life Have customer recharge battery for 24 hours remove battery from charger and re insert into charger for another charge cycle If this does not raise LMD customer should purchase new battery Diametrics Medical Inc Pg 10 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Make sure that the batteries and the charger are the same type CHARGER FAILURE Note Although NiCAD batteries can be recharged in an NIMH charger for optimum performance we recommend keeping the same battery with the same charger Batteries do not fit in charger NIMH products all have on them NiCADs have SL on batteries and no markings on charger Charger lights are not Make sure all connections are firmly in place coming on charger to power supply and power supply to cord and Not charging batteries cord to outlet Yes Try a
67. tamination if low syringe or 0 8cc from a lcc expected pO2 result is syringe less than 150 mmHg Low All users are not removing Room Temperature air bubble from syringe shift low prior to injection Using proper injection Room Air contamination if technique expected pO2 result is greater than 150 mmHg Room Temperature not stable Gel contamination Equilibrated cartridges Room Temperature shift High Diametrics Medical Inc Pg 16 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Confirm that the customer is using 3cc or 1cc syringe i Confirm customer is 18 20 gauge needle Sodium potassium using appropriate ranges gauge nec ionized calcium results for their QC lot and All users are using the same syringe size and needle size out of range IRMA software version Injecting 1 5cc from a 3cc syringe or 0 8cc from a 1cc syringe All users are not removing air bubble from syringe prior to injection Using proper injection technique Equilibrated cartridges Confirm customer is Confirm that the customer is using Hematocrit results using appropriate ranges out of range for their QC lot and 3cc or 1cc syringe IRMA software version 18 20 gauge needle All users are using the same syringe size and needle size Injecting 1 5cc from a 3cc syringe or 0 8cc from a 1cc syringe All users ar
68. ther problems with sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Bubbles or voids in calibration medium Bubbles voids gel fragments or other problems with sample Malfunctioning cartridge Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 46 ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS connector or replace e Bubbles or voids in calibration medium e Bubbles voids gel fragments or other problems with sample e Malfunctioning cartridge HCT PHASE 10 DATA OUT Incomplete cartridge connection to ed
69. tioning get instrument for repair e I ferror is associated with software loading attempt software load again e Lithium battery requires replacement e e e I ferror is associated with software loading attempt software load again e e e 6519 MEMORY FREE ERROR e ferror is associated with software loading attempt software load again e e e e Diametrics Medical Inc Pg 54 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use ERROR DESCRIPTION POSSIBLE CAUSES AND RECOMMENDATIONS 8016 PRINTER INOPERABLE e IRMA printer is malfunctioning get instrument for repair e ferror is associated with software loading attempt software load again e IRMA malfunctioning get instrument for repair 8020 CORRUPTED QC CONTROL e ferror is associated with software loading attempt software load again a NEM EDD MIU MMCMM MIENNE 2 Glucose Bad Gray Read Internal failure of the SSP module Error generated by Lifescan SW Replace module 5 lucos Temperature Faire itera failure ofthe SSP module Error generated by Lifescan SW Replace module s Ghcwe Autoscale Eror 940 tema failure of the SSP module Error generated by Lifescan SW Replace module 9 Glucose Deta Enor660 fimemal failure oF the SSP module Error generated by Lifescan SW Replace module Glucose No Strip Holder Strip Holder gone or broken Replace it Glucose
70. tridge lead problem 5 or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5345 Glucose Amp 1 5th cal value too high Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5346 Glucose Amp 1 6th cal value too high Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge 5347 Glucose Amp 1 drift during calibration Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartridge Glucose Amp 2 4th cal value too high Incomplete cartridge connection to edge connector Possible cartridge lead problem or edge connector problem Clean and dry edge connector or replace Wet cartridge introduced moisture into edge connector Clean and dry edge connector or replace Malfunctioning cartri
71. type of anticoagulant can be used on IRMA DMI recommends Lithium Heparin as the anticoagulant of choice Sodium Heparin may also be used noting that it may falsely elevate sodium results by 2 mM approximate Balanced or low volume heparin is recommended for ionized calcium testing Diametrics Medical Inc Pg 4 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use What type of patient samples should be included in the method evaluation What information needs to be collected DMI recommends the use of patient samples from the facility s general population During preliminary evaluation it is not recommended that CVOR patient samples be used to evaluate hematocrit Accuracy Whole blood split sample study analyzing samples on a reference instrument and IRMA Diametrics recommends a minimum of 20 samples be collected Precision Aqueous Quality control samples analyzed Diametrics recommends a minimum of 10 samples per control level be collected Linearity Aqueous and Whole Blood linearity studies are performed on each analyte Required for CAP customers only How is the data analyzed Accuracy Determine slope intercept correlation coefficient and Sy x Graph all analytes using linear regression and Bland Altman plots Precision Determine mean standard deviation and coefficient of variation Linea
72. uidelines E50 2 0 mg dL or 9 whichever is greater ton Glucose waived test 12 mg dL or 20 Whichever is greater 6 mg dL or 10 Whichever is greater CAP criteria Diametrics Medical Inc Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 59 APPENDIX I Proficiency Survey Information Analyte j SurvyName Blood Gas Sodium Potassium Ionized Calcium Chloride Glucose cartridge method BUN Conductive Hct CO Oximery TH SOU Glucose WB SureStepPro method 800 323 4040 I a Electrolyte BasicChemistty o O Phone 8002345315 1 1 1 O ae a are PONES Blood Gas Blood Gas Blood Gas Elyte Blood Gas Elyte Phone _ 800 356 6788 eee CAP College of American Pathologists AAB American Association of Bioanalysts Diametrics Medical Inc Pg 60 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use APPENDIX J REGULATORY MADE SIMPLE Responsible individuals identified Evidence of specific training with quarterly competency checks Minimum high school diploma or equivalent Personnel Training Quality Control BG one per 8 hr shift or 3 per 24 hrs of testing whichever is greater Lytes two per 24 hrs of testing Het two per 8 hr shif
73. uilibrate cartridges in a stable environment for a an Meet minimum of 72 hours id Performance Specifications Suspect Cartridges are not equilibrated Room Air Contamination if result approaches 0 mmHg Gel contamination 1f result approaches 40 mmHg Something wrong with reference analyzer Pg Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use 19 pO2 results are not what was Are results within expected or did not compare 7 5 of expected to a reference result Room air contamination if result approaches 150 mmHg Sample is mixed venous Time delay in analysis Diametrics Medical Inc Are results out high or low High Room air contamination if result approaches 150 mmHg Gel contamination if result of 160 190 mmHg Time delay in analysis Pg 20 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Sodium Potassium Ionized Are results within Calcium Chloride or BUN Sodium 4mM results not what was Potassium 0 5 mM expected or did not compare ICa 0 5 mM to reference Chloride 5 BUN 2mg dL or 9 whichever is greater Are cartridges properly equilibrated Confirm Cartridge sample is not Meets ertomnados must contaminated specifications equilibrate to r
74. use 14 Confirm that the customer is using Confirm customer is pCO2 results are out of using appropriate ranges 3cc or 1cc syringe 18 20 gauge needle All users are using the same syringe size and needle size Injecting 1 5cc from a 3cc syringe or range for their QC lot and IRMA software version 0 8cc from a 1cc syringe Room Temperature shift High All users are not removing air bubble 1 P Are results out high or from syringe prior to injection a lt low lt Using proper injection technique Cartridges not Ow equilibrated Equilibrated cartridges Room Y Low Temperature not stable Possible hole in Room Temperature shift high Cartridges not equilibrated Room Temperature not stable package 7150 mmHg Gel contamination if expected pCO2 result is less than 40 mmHg Room Air Contamination Gel Contamination if expected pCO2 result is greater than 40 mmHg Diametrics Medical Inc Pg 15 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use Confirm that the customer is Confirm customer is using using appropriate ranges pO2 results out of p range for their QC lot and 3cc or 1cc syringe IRMA software version 18 20 gauge needle All users are using the same syringe size and High needle size Room Air o lt Are results out high or Injecting 1 5cc from a 3cc con
75. where daily quality control testing will be performed in the future such as a designated area at the POINT OF CARE POC This should minimize the effects of temperature variation on aqueous control material The user may find it helpful to record daily room temperatures to determine temperature variation in the area where testing 1s conducted and control materials are stored 3 Quality control materials should be stored at the testing site 4 Testing should be conducted over a MINIMUM of a 5 day period to take into account any variations in room temperature barometric pressure and operator technique 5 During this 5 day period at least 20 samples for each level of control should be analyzed Handling the data 1 Determine the MEAN X for each control parameter pH pCO2 pO2 for each control level X xi N 2 Determine the standard deviation s value from the MEAN calculated in 1 s AX xi N 1 3 Eliminate any values that fall outside of 3 SD of the mean these results may be due to poor sample handling etc 4 Recalculate the MEAN with the remaining values 5 Recalculate the standard deviation Diametrics Medical Inc Pg 26 Note This is a controlled document All changes must be authorized by DMI and revision controlled This document is not intended for customer use By definition Approximately 68 of all determinations should fall within 1 standard deviation of the mean value Approximately 95 of al

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