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User Manual - Accriva Diagnostics

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1. Changing reportable ranges 1 If applicable upload stored results to idms and confirm that existing QC limits and reference ranges do not conflict with the reportable ranges that will be entered Highlight Reportable Ranges from the TEST SETTINGS menu Press edit Highlight the appropriate button a Select Default to set analyzer to default reportable ranges for all analytes Press next to complete entry b Select User Defined to enter custom reportable ranges Press next An analyte picklist is displayed Select the desired analyte from the picklist and press edit If reportable ranges will be changed for multiple analytes select AI Enter the lower reportable range limit and press next Enter the upper reportable range limit and press next Continue for all appropriate analytes 7 14 QUALITY CONTROL QC SETTINGS QA Users can access QC Settings by pressing QC from the SETTING OPTIONS menu The following options are presented Menu Returns to main MENU 9C SETTINGS Settings Returns to SETTING OPTIONS menu eme QC Lockout Allows definition of the number of electronic EQC and or liquid LQC quality control tests required to support patient testing Controls i Controls Allows set up of new controls and editing or deletion of established controls for IRMA TruPoint cartridge and SureStepPro Glucose Module tests If the glucose module is in use refer to the SureSt
2. e On Correlation parameters will be used by the analyzer to adjust IRMA TruPoint patient test results 7 8 Collecting Correlation Data 1 Ensure that the Correlation option is off when collecting correlation data Ensure that the reference analyzer is properly maintained prior to the start of data collection to ensure accurate correlation Obtain at least 50 split sample results for each analyte using the IRMA TruPoint analyzer and the reference analyzer For each split sample use the same syringe the same analysis order and perform both analyses within 5 minutes of each other The measurement range over which the test method is assessed must span the entire clinical range In general this range will extend from below the normal range to substantially higher than the normal range Graph the reference analyzer results against the IRMA TruPoint 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 TruPoint analyzer the X independent variable Perform a linear regression analysis on the results Delete any data points that are more than 3 standard deviations from the regression line Replace them with data acquired from additional split sample analyses and redetermine the regression line The slope and intercept values of the regression line are the factors used for the analyzer to analyzer correlation f
3. Invalid Length Enter X XX characters Invalid Format Enter value in format X XXX X XXX Value out of range Enter a value from X XXX X XXX Cartridge Lot was entered that cannot exist for specified product type Cartridge Lot was entered that cannot exist for the Cal Code entered The length of an entry was invalid too many or too few characters Some features such as Patient ID can be configured to require entry of a specific number of characters The format of an entry was invalid The value entered was outside of the entry range Enter correct cartridge Lot and product type Enter correct cartridge Lot and Cal Code Note the entry length requirements displayed on the screen Press ok and enter a valid number of characters Note the entry format requirements displayed on the screen Press ok and enter the value in a valid format Note the entry range requirements displayed on the screen Press ok and enter a value within the entry range 5 5 SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE TEMPERATURE ERRORS Cartridge out of Cartridge temperature was Remove and dispose of the cartridge temperature range outside of the acceptable re test with a new cartridge within temperature operating range temperature operating range 12 30 C 54 86 F Analyzer out of Analyzer temperature was Press quit to power off analyzer temperature range out
4. QC Test Results CC L1 Lot 12485 pu 7a pco2 40 7 mmig po2 100 1 mmng print fiet 44 Nae 140 3 mm Ke s21 mM limits ica 1114 mM added following the QC test Notes may be added or edited on last result recall done Returns to the QC TEST RESULTS menu Recalling QC Test Results by Search 1 Press search from the QC TEST RESULTS menu The Search QC Results screen presents the search options All EQC Liquid and Temperature icon Select desired search criteria and press next i OG SEARCH QC RESULTS Liquid cancel 2 Screens that appear are based on search criteria selection a Search AIP EQC or Temperature al The First Date from the previous search or the current date automatically displays Accept displayed date or enter a new First Date oldest date for the search in the date format displayed at the top of the screen Press next a2 The Last Date from the previous search or the current date automatically displays Accept displayed date or enter a new Last Date newest date for the search in the date format displayed at the top of the screen Press next 4 5 a3 The QC Results Found screen displays QC Results Found a picklist of all the QC tests that meet saves O a the search criteria and the test dates zaara oas y we and times Scroll through the list of Het Mos Ko ica e results until the desired result
5. 7 19 gt QA Users have access to all analyzer setting and testing functions including User ID settings gt General Users may perform and recall all tests as configured by QA User but have limited access to analyzer set up functions gt Gluc Strip Users may perform and recall only glucose strip EQC and Temperature tests if applicable and have limited access to analyzer set up functions Edit User Privileges can be changed for existing User IDs Delete User Existing User IDs can be deleted from analyzer memory Print Lists A list of all User IDs grouped by Privileges category can be printed Note e The Gluc Strip User privilege is available for users that have purchased the SureStepPro Glucose Module an optional side attachment to the IRMA TruPoint analyzer Refer to the SureStepPro Glucose Module User Manual for details The General User privilege allows both IRMA TruPoint cartridge and glucose strip testing if glucose module is present DEFAULT QA USER ID The IRMA TruPoint analyzer is shipped with a default QA User ID of 123456 Use the default QA User ID to access the User ID Options screen and enter a new QA User ID s Add new QA SETTING OPTIONS Users before deleting the default QA User ID monu e ADDING A NEW QA USER ID i 1 Press User ID from the SETTING OPTIONS e ore menu User ID Options 2 Highlight Add User from the picklist on the naa ser 2 User ID Op
6. Expected Effect Decrease Cl by 12 mmol L Expected Effect Decrease BUN by 2 mg dL Expected Effect Increase glucose by 10 at the 280 mg dL glucose level Increase glucose by 100 at the 120 mg dL glucose level and by 15 at the 325 mg dL glucose level Increase glucose by gt 300 at the 120 mg dL glucose level and by 25 at the 330 mg dL level Increase glucose by 10 at the 80 mg dL glucose level PAM concentrations of 16 mg dL and higher can significantly affect glucose measurements Decrease glucose by 55 at the 325 mg dL glucose level and increase glucose by 100 at the 20 mg dL level Decrease glucose by 30 40 Decrease glucose by gt 10 A 3 Creatinine Substance concentration Acetaminophen 20 mg dL Creatine gt 5 mg dL Hydroxy Urea lt 500 umol L Todoacetate 900 mg dL Isoniazide 7 mg dL Sodium Bromide 100 mg dL Sodium Fluoride 1000 mg dL Thiopental 25 mg dL Expected Effect Increase creatinine by 0 2 mg dL at creatinine levels lt 2 mg dL Results were variable at levels lt 8 mg dL Suppressed creatinine levels were observed at creatine levels gt 5 mg dL Decreased creatinine results by approximately 0 2 mg dL at normal creatinine levels Decreased creatinine results by approximately 50 at both the 0 9 and 8 7 mg dL creatinine levels Decreased creatinine results by approximately 15 at the 0 9 mg dL creatinine level No effect was obs
7. Select Language i Enanich IRMA TRUPOINT TOUCHSCREEN INTERFACE The IRMA TruPoint touchscreen guides the user through each procedure using screens containing simple directions buttons and graphics Most IRMA TruPoint screens have a title at the top of the screen that describes the on screen display IRMA TruPoint uses the following conventions and screen icons Does not save entries on the current screen and returns to the previous screen Returns to the beginning of the procedure and does not save entries made throughout the procedure Completes the current procedure and returns to the appropriate menu Allows a displayed or highlighted screen item or setting to be changed Proceeds to the next step in the procedure Test Information Button displays on screens where patient test information can be added to test result record and initiates patient test information entry Oxygen Therapy Button displays on screens where patient oxygen therapy information can be added to test result record and initiates patient oxygen therapy information entry 1 10 Bypass Status Button displays on the Calibrating and Analyzing screens when available When On Bypass option is selected Bypass Correlation hematocrit results are reported Temperature Test Button displays on the QC TEST OPTIONS screen and initiates an IRMA TruPoint temperature test QC Lockout Icon may be displayed on the Selec
8. a Passed Temperature Test al Press notes to select QC notes to attach Tapeti Tet to the record optional a2 Press print to obtain a printout Results may automatically print depending on the auto print setup HE a3 Press done to return to the QC TEST OPTIONS screen b Failed Temperature Test bl Press help for assistance in resolving Temperature Test the problem that caused the failure a ant optional _ owe b2 Press notes to select QC notes to attach Bel TCA to the record optional b3 Press print to obtain a printout Results may automatically print depending on the auto print setup b4 Press done to return to the QC TEST OPTIONS screen REFERENCES 1 Elin RJ Elements of cost management for quality assurance College of American Pathologists pp 182 183 April 1980 3 14 Section 4 Data Access OVERVIEW This section describes the IRMA TruPoint data storage capabilities the procedures for patient and QC test result recall and result transfer to idms or other connected system DATA STORAGE Results can be recalled printed and or transferred to other systems The analyzer stores the following number of test records even when powered off or when the battery is removed e 200 patient test records e 150 liquid QC records 100 EQC Temperature Test results Error codes for the last 10 failed EQC Temperature Tests Access the RECALL menu by
9. 2 Connect the bar code reader to the clip Figure 1 7 Operating the Bar Code Reader General To scan a bar code position the bar code 3 6 inches 7 15 cm from the reader light source window Press and hold the button on the bottom of the reader and align the red light line with the bar code The red light line will turn off and the IRMA TruPoint screen will advance when the scan is complete Figure 1 8 Operating the Bar Code Reader Patient Sample Analysis and QC Testing If a bar code reader is connected to the IRMA TruPoint analyzer the appropriate screen prompts will display upon initiation of a patient test or liquid QC test The bar code scanner can be used to scan the following items e UserID e Patient ID e Cartridge Information Product Type Lot Code and Cal Code are encoded in the single bar code found on each cartridge package label e Glucose Test Strip Information Product Type Strip Lot and Ctl Code are encoded in the two bar codes found on each test strip bottle label e QC and Calibration Controls QC product level lot number expiration date and expected values are encoded in the series of bar codes located on the ITC expected values sheet These sheets are located at www itcmed com 1 Enter User ID optional If the User ID ee option is activated the Enter or Scan ID sf Comet screen will display The User ID may be entered using either the alpha numeric DDYDD keypads or the bar code s
10. 2 For master only defaults select Master on Reference Range Settings and Type Specific off Press next a To activate previously defined values Q ume riot press ok remain Q This message will only be displayed if a reference range has been established b Enter a Reference Range Description up to 12 characters Press next 7 12 c Select desired analyte from the picklist If reference ranges will be entered for multiple analytes select Al Press edit d Enter the lower reference limit and press next e Enter the upper reference limit and press next Select Type Specific Reference Range mo f Continue for all appropriate analytes When complete press done To set Type Specific reference ranges select Type Specific on and Master off Press next a To activate previously defined values press ok b Select Reference Range Group Press edit c Enter Reference Range Group Name Press next d Select Reference Range Type Press edit e Select desired analyte from picklist If reference ranges will be entered for multiple analytes select All Press edit f Enter the lower reference limit and press next g Enter the upper reference limit and press next Reference Range Settings en OC on Type Specific S next Select Reference Range Group O SI ee OO SI O al Newborn Refere
11. 2 91 137 86 0 168 0 1 110 22 71 0 998 2 14 D 1 ACCURACY CONTINUED Potassium K Number of samples 137 Range evaluated mM 1 5 13 8 Slope 0 961 Intercept 0 033 Correlation Coefficient r 0 999 Sy x 0 217 Ionized Calcium iCa Number of samples 137 Range evaluated mM 0 80 5 70 Slope 1 019 Intercept 0 063 Correlation Coefficient r 0 997 Sy x 0 136 Chloride CI Number of samples 56 Range evaluated mM 74 8 136 4 Slope 0 956 Intercept 4 64 Correlation Coefficient r 0 986 Sy x 3 0 Hematocrit Hct Number of samples 137 Range evaluated 22 0 60 5 Slope 0 883 Intercept 2 645 Correlation Coefficient r 0 978 Sy x 2 45 Blood Urea Nitrogen BUN Number of samples 56 Range evaluated mg dL 12 5 74 6 Slope 0 985 Intercept 0 46 Correlation Coefficient r 0 995 Sy x 1 9 D 2 ACCURACY CONTINUED Glucose Glu Number of samples Range evaluated mg dL Slope Intercept Correlation Coefficient r Sy x Creatinine Cr Number of samples Range evaluated mg dL Slope Intercept Correlation Coefficient r Sy x Lactate LA Number of samples Range evaluated mmol L Slope Intercept Correlation Coefficient r Sy x 37 19 338 0 970 5 47 0 992 11 08 110 0 5 10 1 0 940 0 16 0 981 0 55 117 1 1 11 5 0 959 0 032 0 98 0 46 D 3 PRECISION Precision was performed on commercially
12. ATemp I gt A Temp is T 37 MDRD GFR MDRD GER mL min 1 73m2 186 X CR 54 x age 0 203 X 0 742 if female x 1 21 if black mg dL mg dL sek years C 6 REFERENCES 1 Oesch et al Ion Selective Electrodes for Clinical Use Clinical Chemistry 1986 vol 32 no 8 p 1448 2 Maas et al Ion Selective Electrodes for Sodium and Potassium A New Problem of What is Measured and What Should be Reported Clinical Chemistry Vol 31 no 3 1985 p 482 3 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 5 5 C12 A 9 94 equations 6 7 9 4 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 5 9 C12 A 9 94 equation 15 5 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 5 8 C12 A 9 94 equation 14 6 Burnett and Noonan Clinical Chemistry 20 12 1499 1506 1974 7 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 6 0 C12 A 9 94 equation 23 8 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 6 0 C12 A 9 94 equation 24 9 National Committee for Clinical Laboratory Standards NCCLS Vol 14 No 11 Section 6 0 C12 A 9 94 equation 25 10 Kelman GR Nunn JF J Appl Physiol 1966 Vol 21 1484 1490 11 Siggaard Andersen O Wimberley P D Fogh Andersen N Gothgen I H Measure
13. Class B Group 1 EN 55011 1998 w A1 1999 amp A2 2002 Class B Group 1 EN 60601 1 2 2001 Emission Requirements This equipment has been tested and found to comply with the limits for medical devices to EN 60601 1 2 2001 This testing shows that the device provides reasonable protection against harmful interference in a typical medical installation However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to other devices or is negatively impacted by other devices the user is encouraged to try to correct the interference by one or more of the following measures reorient or relocate the devices increase the separation between the devices connect the equipment to an outlet on a different circuit consult the manufacturer or field service technician for help Equipment connected to the serial port must comply with the respective IEC standards e g IEC 950 for data processing equipment and IEC 601 1 for medical equipment Furthermore all configurations shall comply with the system standard IEC 601 1 1 Anybody who connects additional equipment to the signal input or output part is considered to be configuring a medical system and is therefore responsible for ensuring that the system complies with the requirements of the system standard IEC 601 1 1 If in doubt consult the technical service department or your local representative IEC 1000
14. an option go to step 3 c If LAN 10 100 is highlighted or User Selects is highlighted on an analyzer that has LAN 10 100 as an option go to step 4 3 Enter the phone number of the receiving ie Pilots Neate system Enter a comma after any digits that XXXXXXXXXXX_ Ee may result in a phone line switching delay DDOOOO e g after 9 is pressed to access an outside DEO next line Press next Go to step 5 4 The LAN 10 100 Settings screen displays un aiis Sw 01 2 0302103 xpr Peek a If the information displayed is correct press aii A Gateway IP 0 0 0 0 it next and go to step 5 SubmetMask 255 0 0 0 ee Rom IP Adr 9 0 0 0 Rem Port 3001 aort b If the information is incorrect press edit b1 The IRMA TruPoint IP Address screen displays Enter the IRMA TruPoint IP a h Co Address using the format 3 P er aaa enn D00000 aaa bbb ccc ddd where aaa bbb on oe 29 oe 29 ae 9 D 9 3 9 2 ccc and ddd are each a to 3 digit value ranging from 0 to 255 Press next cateway b2 The Gateway screen displays Co Highlight the on button to enable D Network Gateway support or the off oot button to disable Network Gateway support Press next If on was selected enter the Gateway l IP Address and press next DDOQQ 7 24 5 b3 The Subnet Mask screen displays This screen defines which bits are significa
15. but the transmission is Unable to Transfer unsuccessful an error message will display Transfer and receiving a Resend verify connections and receiving system system and press resend button b Cancel transmission press cancel button Transmitting Recalled Results All IRMA TruPoint patient test results can be recalled and transmitted to VueLink A result can be transmitted multiple times A result cannot be edited in IRMA TruPoint once it has been transmitted to VueLink Transmitting a result to VueLink does not affect its sent unsent status for transmission to idms or a host system DEVICE COMMUNICATION UTILITY DEVICECOM Description DeviceCom is a PC software application that handles all communications between the IRMA TruPoint device and other software programs such as idms DeviceCom Setup There is no specific DeviceCom setup required in IRMA TruPoint See the Device Communication Utility User Manual for DeviceCom setup instructions DEVICESET Description DeviceSet is a PC software tool that provides an easy and efficient way to create modify restore and manage configuration settings on all IRMA TruPoint instruments at a site Settings profiles are established in DeviceSet and then a profile is assigned to one or more IRMA TruPoint analyzers A profile is a collection of IRMA TruPoint settings that includes most of the IRMA TruPoint settings that may be manually established via the IRMA TruPoint SETTI
16. grouping choices for User Selects setup the user will have the choice of selecting the individual analytes available on that product type with each test Press next to complete entry LOT ENTRY H3 Setup C back So User j boi K next QA Users can enter a new product lot and Cal Code into the analyzer memory using the Lot Entry option Cal Codes from previously entered product lots can also be edited via this option Entering a new product lot 1 Highlight Lot Entry and press edit 2 Highlight the appropriate product type and press next 3 Highlight new in the picklist Press edit Up to 3 lots for each product type can be entered when the maximum of 3 has been reached the oldest lot for that product type will be deleted 4 Enter the product lot code and press next 7 3 TEST SETTINGS Product Setu 4 Calculati Sea e Product Types Pe Lot cua on I om done 5 Enter the Cal code and press next to return to Cal Code the Lot picklist Press done to return to TEST I SETTINGS wos ao F Be T aes tif AG next Note e New product lots that are entered via patient test or QC test will appear in the Lot picklist following entry Replacing an existing product lot with a new product lot 1 Highlight Lot Entry and press edit Highlight the appropriate product type
17. 4 2 1995 EN 61000 4 2 1995 IEC 1000 4 3 2002 EN 61000 4 3 2002 IEC 1000 4 4 1995 EN 61000 4 4 1995 IEC 1000 4 5 1995 EN 61000 4 5 1995 IEC 1000 4 6 1996 EN 61000 4 6 1999 TEC 1000 4 8 1993 EN 61000 4 8 1994 TEC 1000 4 11 1994 EN 61000 4 11 1994 Part 68 FCC Regulations Use in aircraft the use of IRMA TruPoint with an unterminated distal end of a data transmission cable will result in emissions that exceed FAA radiative emissions test RTCADO 160C B 3 Guidance and Manufacturer s Declaration Electromagnetic Emissions The IRMA TruPoint Blood Analysis System AC adapter is intended for use in the electromagnetic environment specified below The customer or the user of the IRMA TruPoint Blood Analysis System AC adapter should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The IRMA TruPoint Blood Analysis System AC CISPR 11 adapter uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions Class B The IRMA TruPoint Blood Analysis System AC CISPR 11 adapter is suitable for use in all establishments Harmonic Emissions Class A including domestic establishments and those directly TEC 61000 3 2 connected to the public low voltage power supply Voltage Fluctuations Conie Sora s
18. 40 tests when fully charged Test yield will depend on other factors e g cartridge type amount of printing etc Figure 1 3 A Power Supply and Attached Cord connects to battery charger B Wall Cord makes connection between the power supply and electrical wall outlet C Battery Charger holds battery during the charging process Caution Battery charger with power supply is not intended for use within a 1 5 meter radius of patient 1 4 IRMA TRUPOINT AC POWER ADAPTER The IRMA TruPoint analyzer can be operated on AC power using the IRMA TruPoint AC power adapter e The analyzer will not automatically shut off when the AC adapter is in use and can be left on indefinitely e After two minutes of inactivity the analyzer will enter into sleep mode screen goes dark The user can return to the last screen displayed by touching the right side of the screen at anytime during sleep mode e If the user ID feature is enabled then the user ID screen will be displayed before the analyzer can be accessed again e The analyzer power can be left on indefinitely e The analyzer can be shut off via the quit button on the main MENU Figure 1 4 A Power Supply and Battery Shell are permanently connected via the adapter cord The battery shell fits into the IRMA TruPoint battery compartment B Wall Cord makes connection between the power supply and electrical wall outlet IRMA TRUP
19. 440100 and a bar code reader PN 463120 Contact your service provider for information on these and other IRMA TruPoint products 1 2 IRMA TRUPOINT BLOOD ANALYZER Figure 1 2 A B C D Carrying Handle On board Printer provides hard copies of test results and information Rechargeable Battery provides portable analyzer power Touchscreen guides user through all aspects of analyzer operation including analyzer setup information entry and display and testing The analyzer is powered on by touching the right hand edge of the touchscreen Edge Connector Block electronically connects the cartridge to the analyzer This removable connector protects the analyzer from internal damage by spilled liquids or other contaminants Infrared IR Probe recessed measures and controls sample temperature for appropriate tests G Temperature Card Storage Area underneath provides on board storage of the Temperature Card IRMA TRUPOINT BATTERY CHARGER AND POWER SUPPLY The IRMA TruPoint analyzer can be operated on battery or AC power The IRMA TruPoint battery power system consists of two rechargeable nickel metal hydride NiMH batteries and an external battery charger and power supply e NiMH batteries take approximately 5 5 hours battery empty when placed in charger to 10 hours battery full when placed in charger to charge A fully charged batter will yield approximately 30
20. Battery does not charge W nn e Fully charged battery is yielding 1 fewer than expected tests or the battery icon on the IRMA TruPoint screen does not display D D Verify that the battery charger is plugged into the power supply prior to battery insertion Verify that the battery is fully inserted yellow indicator light comes on upon insertion of the battery into the charger Inspect battery and battery charger contacts for damage Clean the contacts on the battery battery charger and analyzer battery compartment See Section 6 Maintenance for details Verify that a NiMH battery is being charged in a NIMH charger not a NiCad charger See Section 6 Maintenance for details Call your service provider Condition the battery See Section 6 Maintenance for details 5 2 PROBLEM CORRECTIVE ACTION S PRINTER PROBLEMS e Poor print quality e Printer paper advances but nothing is printed printer sounds are audible e Paper does not advance during printing e Printer does not operate il pa 1 i Only use paper supplied by your service provider Try a new roll of paper Verify that paper rolls and printouts are not exposed to sunlight or fluorescent light for an extended time period Only use paper supplied by your service provider 2 Verify that the paper roll unwinds in the proper direction since printing is possible only on one side of the paper Se
21. MAIN MENU ACCESS All IRMA TruPoint test setup and recall options are accessed via the main MENU To access the main MENU 1 Touch the right hand edge of the screen to turn the analyzer on a If the User ID option has not been activated the main MENU automatically appears at start up b If the User ID option has been activated the Enter ID screen appears This option requires the entry of a valid User ID code before the analyzer can be used Following entry of a User ID the main MENU displays The main MENU also appears following completion of a test by pressing the done button mnj a on or the Menu button from other screens neen re Settings 09 14 06 10 30 patient tost ALTERNATE LANGUAGES The IRMA TruPoint analyzer software is available in multiple languages All available languages are automatically loaded into the analyzer during the software installation process To select an alternate IRMA TruPoint analyzer software language 1 Touch the right hand edge of the screen to start power up Press down and hold the ITC logo that appears in the center of the screen Te during power up Continue to press down logo will flash off until the Select Aopen vi Language screen appears i The Select Language screen displays a picklist containing all available analyzer languages Highlight the desired language rica and press next The main MENU displays in the language selected
22. Open Cartridge Package 7 Check the expiration date on the cartridge package The analyzer will not allow testing with expired cartridges Note Cn Dime V 0M o gt 0 a NEN OR WAU Pam Verify Information TruPoint the Lot expired message will display and the test cannot proceed Remove expired cartridge and initiate a new test with an in date cartridge If the wrong lot was selected on the Verify Information screen press ok to return to the Verify Information screen and press edit to enter or select the correct cartridge lot 8 Remove the cartridge from the package and retain the package until cartridge information is verified Remove Tape and Insert Cartridge into Analyzer Fi 2 4 9 Remove the protective tape from aoe the cartridge leads if applicable 2 7 Do not touch the cartridge leads after the tape has been removed Cita Do NOT remove the luer cap C7 from the cartridge Figure 2 4 N D Fi 2 5 10 Fully insert the cartridge into the s Iure analyzer within 15 minutes of opening the package Figure 2 5 Note e Do not use a cartridge if it has been out of the package longer than 15 minutes do not reuse a single use cartridge once it has been inserted into the analyzer Verify Enter Cartridge Information 11 Ensure that the product type Type Verify Information displayed on the Verify Information screen is correct If the product type displayed does not match the type
23. QC Lockout schedules User ID Advances to the USER ID OPTIONS menu Set up or modify user identification numbers and privileges Device Advances to the DEVICE SETTINGS menu Access setup screens for beeper barometer communications date format analyzer date and time printer and screen contrast All IRMA TruPoint system settings are maintained in the microprocessor s memory even when the analyzer is turned off or the battery is removed 7 1 TEST SETTINGS QA Users can access Test Settings by pressing Test from the SETTING OPTIONS menu A TEST SETTINGS picklist displays Current test settings can be viewed or changed by highlighting a category in the TEST SETTINGS picklist and pressing edit PRODUCT SETUP QA Users can use the Product Setup option to TEST SETTINGS Product Setup Lot Entry 4 eas AY 2l Define the product types that are in use at their facility With each patient test the user is prompted to enter the product type being run Only those product types defined in the Product Setup option will appear on the Select Product Type screen with each test if a single product type is defined the analyzer assumes that all cartridges inserted for testing are of that type and no Select Product Type screen will appear e Define the analytes that will be reported for each cartridge type Note that all analytes will always be reported for BG cartridges Defining the product
24. and QC Lockout is on and Lockout requirements have not been met a QC lockout screen displays QC LOCKOUT SCREENS If a patient test is initiated and QC Lockout is on and Lockout requirements have not been met one of the following lockout information screen displays Unable to Start Test e All Analyte Groups and Product Types are locked out none of the QC lockout QC Required requirements for the current shift have been ce GR BG LA satisfied n3 Glue Strip ok gt Press ok to return to main 2 20 e Some but not all Product Types are EAE peo completely locked out for all analyte groups _ _ available on that product A padlock will sej display over the selection button preventing _ jej wot selection of that product type until QC lockout requirements have been satisfied gt Select a product type that is not locked out and press next to continue test or gt Press cancel to return to main e Product types that are partially locked out QC Lockout some but not all analyte groups available fra will not show a padlock icon over the selection zielne button When selected a screen detailing the analyte groups not available for testing will display gt Press ok to continue testing for available analyte groups or Ci li gt Press cancel to return to main REFERENCES 1 Tietz N Clinical Guide to Laboratory Tests Fourth Edition Philad
25. and begin again with a new cartridge Proper injection technique will prevent air bubbles or calibration gel from being present in the sample path after initial sample injection Analyzing kz 19 Ensure that no air bubbles or calibration gel are present in the sample path then immediately press test to continue sample Te analysis The Analyzing screen displays 20 When the test is complete remove the cartridge with the collection device attached Dispose of both in accordance with established guidelines for your facility View Test Results 21 Verify that the quality control test results fall within accepted limits If control limits have been established results falling outside the limits will flash An H High or L Low will appear on the printout next to values falling outside the limits Press limits to view control limits Gf established If results are not within the limits take corrective action in accordance with established guidelines for your facility 3 11 22 If a sensor errors during the analysis phase of a liquid QC test the result for that sensor and any other sensors that are dependent on that sensor will be suppressed Suppressed results will be dashed out on both the screen and printout and will not satisfy QC lockout requirements for the associated analyte group with or without QC limits established Document QC Notes optional 23 The QC Notes feature
26. and hct analytes selected the tHb value that is calculated from the hct test will be used in the BEb calculation If Default or Manually Entered was selected Calculated Values setup is complete 5 If Calculated was selected chose an alternate tHb source to be used when a calculated tHb is not available and press next Highlight the button next to one of the following options a Default value 15 g dL is automatically n e oo used in the BEb calculation poru O woot j 45 g dL b Manually Entered value User manually pra a aes enters a patient hemoglobin value with each Gael test Calculated Values setup is complete Selecting the formulas to be used to derive the calculated values Selecting Base Excess and Bicarbonate Formulas 1 Highlight Formulas and press edit Calculations Calculated Values A Ww oait done 4 2 Highlight the button next to the formula to be BE HCOS Calculation used in the calculation of base excess and cancer bicarbonate Press next cas icemandeeen C aon Siggaard Andersen next 7 5 e Selecting a pO gt Temperature Formula 1 Highlight the button next to the formula to be p02 Temperature used in the calculation of patient temperature C corrected results severinghaus These formulas are further described in Bee Q Appendix C TEST INFORMATION QA Users can define the Test Information i
27. and press next Scroll down the picklist until the existing lot number is highlighted Press edit 2 Enter the new lot code and press next Enter the new Cal Code and press next to return to the Lot picklist The new lot replaces the old lot in the picklist Press done to return to TEST SETTINGS CALCULATIONS QA Users can define the calculated values to be reported with each test and the formulas used to derive the calculated values using the Calculations option Defining the calculated values to be reported with each patient test 1 Highlight Calculations and press edit TrsT ertia 2 Highlight Calculated Values from the picklist Calculations and press edit Calculates vation ICN ormulas Sm 3 Highlight the calculated values to be reported Piresi ales depends on product type with each patient EE ca test and press next ore If BEb was not selected Calculated Values es ca cH setup is complete 7 4 4 If BEb was selected chose the source of the patient hemoglobin value to be used in the BEb calculation and press next Highlight the button next to one of the following options a Default value 15g dL is automatically EVER EHD for BED Calculation used in all BEb calculations ac back j b Manually Entered value User manually sted C 7 enters a patient hemoglobin value with each eromen C ca test c Calculated value If a CC cartridge is run with both blood gas
28. confirmation screen to print list or press edit to return to list selection screen 7 21 DEVICE SETTINGS Device Settings determine the operating functions for the IRMA TruPoint system e Non QA Users can access and change the beeper date format time printer and screen contrast functions e QA Users can access and change the above functions as well as the change the date calibrate barometer and communications functions All users can access the DEVICE SETTINGS DEVICE SETTINGS menu by pressing Device from the SETTING OPTIONS menu To access a device setting highlight the desired option from the picklist and press edit BEEPER There are 2 beeper options e Off The beeper is disabled e On The analyzer automatically beeps to alert the operator when an action is required or a result displays 1 Highlight the on or off button and press next CALIBRATE BAROMETER 1 Run an EQC test When the test is completed DEVICE SERTINGS compare the IRMA TruPoint barometer reading to the reference barometer reading by accessing DEVICE SETTINGS from the SETTINGS OPTIONS menu Scroll down until Calibrate Barometer is highlighted IRMA TruPoint s current barometric pressure displays below the DEVICE SETTINGS scroll box Compare the value displayed on IRMA TruPoint to the reference barometer If they are the same press done 2 If the barometer needs
29. correlation parameters will be deleted following the completion of new data entry 3 Press edit to enter the slope and or intercept value for the highlighted analyte 4 Enter slope value and press next POOa Slope 1 000 YIVI9O9 O QDOVOD J 5 Enter intercept value and press next to return B02 Intercept to the Select Analyte screen Refer to 0 00 mme a pacit Appendix B Table B 10 for correlation factor DIODOG limits for each parameter QDYOQVDO oe 6 Repeat for each analyte to be correlated Press done from the Select Analyte screen when finished Note e Correlation parameters will be used in the calculation of patient results only when Correlation is turned on The slopes and intercepts will be stored in the analyzer memory but will not be used in the calculation of results when Correlation is turned off Correlation should be deactivated when proficiency samples are analyzed Using the correlation feature will alter the calculation of all subsequent patient test results but will not affect results previously performed 7 10 BYPASS CORRELATION QA Users can establish correlation factors for samples from patients on cardiopulmonary bypass to adjust IRMA TruPoint patient test hematocrit results to values that would be expected if samples were run on another analyzer i e designated reference analyzer These correlation factors are based on split sample blood results fro
30. dL 0 1 mM Glucose 1 mg dL 0 1 mM Creatinine 0 01 mg dL 1 pmol L MDRD GFR 10 00 mL Lactate 0 1 mM mg dL min 1 73m2 Note mM is the IRMA TruPoint display abbreviation for mmol L Default display units are bolded B 8 CORRELATION FACTOR LIMITS Refer to Section 7 Correlation for a description of the correlation feature and instructions Correlation factors must be within the following limits Table B 10 Parameter Slope Intercept pH 0 to 10 000 9 9999 to 9 9999 pCO 0 to 10 000 999 99 to 999 99 mmHg 133 32 to 133 32 kPa pOr 0 to 10 000 999 99 to 999 99 mmHg 133 32 to 133 32 kPa Nat 0 to 10 000 999 99 to 999 99 mM mEq L Kt 0 to 10 000 9 999 to 9 999 mM mEq L iCa 0 to 10 000 9 999 to 9 999 mM 20 00 to 20 0 mEq L 40 08 to 40 08 mg dL cr 0 to 10 000 999 99 to 999 99 mM mEq L Hct 0 to 10 000 999 00 to 999 00 9 9900 to 9 9900 SI BUN 0 to 10 000 999 9 to 999 9 mg dL 356 96 to 356 96 mM Urea 0 to 10 000 2139 8 to 2139 8 mg dL 356 27 to 356 27 mM Glucose 0 to 10 000 999 9 to 999 9 mg dL 55 55 to 55 55 mM Creatinine 0 to 10 000 99 999 to 9 999 mg dL 8839 9 to 8839 97 umol L Lactate 0 to 10 000 99 99 to 99 99 mM 899 91 to 899 91 mg dL REFERENCE VALUES While published values represent the general population each laboratory should establish its own normal values which reflect the local patient population and equipment used at the s
31. environment voltage variations 40 Up 40 UT If the user of the IRMA TruPoint on power supply 60 dip in UT for 5 60 dip in UT for Blood Analysis System AC adapter input lines cycles 5 cycles requires continued operations during 70 Ur i 70 UT power mains interruptions it is reco TEC 61000 4 11 a Ea in UT for A in UT for mmended that the IRMA TruPoint Blood Analysis System AC adapter lt 5 UT lt 5 U To be powered from an uninterruptible gt 95 dip in UT for gt 95 dip in UT for power supply or battery 5 sec 5 sec Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz should be at levels characteristic of a magnetic field typical location in a typical domestic TEC 61000 4 8 commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level B 4 Symbol Definitions Definitions for symbols that appear on IRMA TruPoint product labels are shown in Table B 4 Table B 4 Symbols Definition Batch code REF Catalogue number A Caution refer to accompanying documents Cli Consult instructions for use Q Do not re use In vitro diagnostic medical device ew Manufactured by SN Serial number Temperature limitation X Use by ol Class II Electrical Shock Protection Name and address of authorized representative in the S lt European Community EU Patents Table B 5 The IRMA TruPoint Blood Analysis Sy
32. is highlighted The product type QC lot and level and analytes are shown below the picklist for the highlighted result if applicable Press print all to print a detailed hard copy for all results found in the picklist Press view to see the results for the highlighted result only The options from the results screens vary with QC type EQC or Temperature Test Result v print Prints a hard copy of the EQC Results result selected print v view Present only on Passed EQC Displays quantitative results and ew ne limits Press next from each results screen to view results for the next analyte v done Returns to the QC Results Temperature Tost Found screen ae sa ae v help Present only on Failed EQC or Temperature test Provides assistance ue j in resolving the problem that caused the failure Liquid QC Test Result gt print Prints a hard copy of the e neon result selected foes 40 7 maite go 5 po2 100 1 mmHg gt view Displays QC limits if they A aes Seam have been established by the QA ints Nico iia mu sone User v done Returns to the QC Results Found screen b Search Liquid QC b1 Highlight the desired Product Type on Select Product Type the Select Product Type screen and press e mae E g next ee e n fso ont 4 6 b2 The Select Control screen displays a picklist with the control lots and levels a
33. is selected enter the FIO and press next If Simple or NRB is selected enter the oxygen flow L min and press next v v If Other is selected enter mask type up to twelve characters enter the oxygen flow L min and press next Nasal Cannula Mode Oxygen Flow e The Oxygen Flow screen appears following selection of Nasal Cannula from the Oxygen Therapy screen Enter the oxygen flow L min and press next CPAP Mode e The CPAP screen appears following selection of CPAP from the Oxygen Therapy screen Enter the CPAP cm H20 delivery pressure and press next 2 SC ce ELE ce ce ee Ce e Enter the FIO and press next Other Mode Other Oxygen The Other Oxygen screen appears following o sa selection of Other from the Oxygen Therapy 0 oo e24 DDOD screen Enter the form of oxygen therapy up to WWD DS DWV wont twelve characters Press next DWV e Enter associated comments up to twelve characters Press next OXYGEN THERAPY ENTRY MISCELLANEOUS If oxygen therapy information entry is completed before calibration is complete the operator is automatically returned to the Calibrating screen If calibration completes at any time during oxygen therapy information entry the CALIB COMPLETE message appears in the upper right corner of the information screen Complete information entry or press next through each remaining screen to sav
34. of the cartridge inserted into the analyzer press next Proceed to step 13 b If the lot number displayed does not match the lot number of the cartridge inserted into the analyzer press edit to choose a different previously entered lot or enter a new lot for the first time bl To choose a previously entered lot Let highlight the correct cartridge lot new 4 a from the picklist Press next to return cone v to the Verify Information screen If the commons next information is correct press next to continue QC test If the information is incorrect press edit to re enter the lot number and Cal Code b2 To enter a new cartridge lot for the Lot first time highlight new from the 4 icklist and press edit coen Y can p P ee oS next gt Enter the cartridge lot number Lot ABCDE back from the keypad Press next DEOD DA ae DWDD Pe Leas gt Enter the Cal Code from the Gal Code keypad Press next to return to the D DEORE a J Verify Information screen If the PDD information is correct press next to LS PTPR next continue liquid QC test If the information is incorrect press edit to re enter the lot number and Cal Code 3 9 Dispense Calibrant Cartridges with Cal Cap Only 13 For cartridges that have a Cal Cap H4 GL CR LA the Dispense Calibrant screen displays with countdown timer at bottom Follow the on screen instructions for dispensing the calibrant over the senso
35. print EQC failed will print and the EQC Results failed screen will display b6 Press done to return to the main MENU or the User ID entry screen if required Another auto EQC test will initiate following the next inactivity period or a manual EQC test can be performed 3 5 Note e When EQC Lockout is on an EQC test failure at any time i e even if EQC passed earlier on a shift will lockout patient testing Following an EQC test failure a passed EQC test is required to resume patient testing AUTOMATIC EQC TEST Refer to Section 7 QC Lockout for configuration instructions LIQUID QUALITY CONTROL This section of the manual describes the liquid quality control test procedure following set up of the control parameters control type lot number level and limits by the QA User If controls have not been established the Unable to run QC Test No Controls Defined message will appear when an liquid QC test is attempted Before the test is started review the control sample preparation recom mendations described in steps 15 17 on page 3 10 LIQUID QC MATERIAL REQUIREMENTS The IRMA TruPoint system requires liquid controls to verify cartridge shipping and equilibration conditions Control linearity and proficiency testing material recommendations and ranges are available on the ITC website www itcmed com or from your service provider or ITC Technical Services IRMA TruPoint BG CC and LA ca
36. results Settings emco Transfer time 12 minutes gt Unsent results will automatically be transferred when ok is pressed from the Updates Available screen 1 21 c Result Transfer setting is host and there are unsent results gt Results must be manually transferred to the host system before the update can be Attention You must upload results before transfe device updates initiated Press ok to return to the main MENU d Result Transfer setting is off and there are unsent results gt The unsent stored results may be deleted during the software update Press ok to continue update if stored results have already been retrieved or if it is acceptable Warning Software update may result in loss of stored results If necessary retrieve results before continuing update x that they may be deleted gt Press cancel to cancel update and retrieve results When the update is complete THE SETTING OPTIONS menu will display 1 22 Section 2 Patient Sample Analysis OVERVIEW This section describes the procedure for performing a whole blood patient sample analysis on the IRMA TruPoint analyzer including sample require ments sample collection and sample handling guidelines SAMPLE REQUIREMENTS ACCEPTABLE SPECIMENS Fresh arterial or venous whole blood collected in a 1 2 or 3 mL lithium heparin syringe Balanced or low vo
37. screen will display Enter information or press next to advance to the next entry screen Patient ID Patient ID is the only test information item that may require entry When Patient ID was enabled by the QA User two options were available for selection e Optional Patient ID Entry enter a one to twelve character ID to identify the sample or press next to leave the Patient ID blank e Required Patient ID Entry enter a one to twelve character ID to identify the sample Results will not display or print until a Patient ID is entered and next is pressed This screen cannot be bypassed the only way to exit this screen is to enter a Patient ID e To automatically display the Patient ID from Patient 1D the last patient test performed press Prev ID e If the ID entered or displayed exists in the V229 5 stored results the remainder of the Test 9OD9VOO I Information fields are assigned the same values as the most recent result for the same product type If the previous values are correct press next to accept the values displayed or change values as necessary 2 13 ote If Patient ID entry is Required and a patient ID was not entered during the Calibrating phase the Patient ID screen will display instead of the Analyzing screen after sample injection A patient ID must be entered before results will display or print Enter a patient ID and press next to advance to the Analyzing or Results screen If
38. seal off the end of the collection device gt Store the blood gas sample in an ice slurry gt Thoroughly mix the sample while the cartridge is calibrating 2 2 Capillary samples must be free flowing from an arterialized site Avoid excessive squeezing of the puncture site to prevent erroneous results that could result from dilution of analytes or hemolysis ELECTROLYTE GLUCOSE LACTATE SAMPLE H ANDLING If a blood sample cannot be tested within 20 minutes of collection keep the collection device capped to minimize pH changes that could affect the ionized calcium concentration Do not ice samples that are to be analyzed for potassium iced samples may hemolyze Analyze samples that are to be tested for glucose immediately glucose will decrease 5 10 mg dL hour as a result of glycolysis Samples for lactate should be analyzed immediately on drawing as lactate increases by as much as 70 within 30 minutes at 25 C as a result of glycolysis PREPARING THE SAMPLE FOR INJECTION Remove any entrapped air from the syringe sample by pointing the syringe at an upward angle to allow air bubbles to rise to the surface expel the air along with a small amount of blood onto an absorbent surface Mix the sample thoroughly using the following technique gt Roll the syringe between the palms of both hands with the syringe tip pointing up gt Invert the syringe i e tip down after 15 30 seconds Continue to roll the s
39. that sensor Electronic Quality Control EQC 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 TruPoint sensors during a cartridge test During an EQC test an isolated region of the internal circuit board sends a range of simulated sensor signals through the cartridge measurement channels The range of signals generated encompasses the entire linear range expected from blood analysis This measurement is followed sequentially by measurements of conductivity out to the connector pins insuring that no contamination is present in the edge connector which would interfere with test results Signal measurements must fall within strict predetermined thresholds for the test to pass IRMA TruPoint EQC is an internal method and does not require the use of an external EQC card Analyzers powered by AC adapter can be configured to automatically run EQC tests per a preconfigured schedule Liquid Quality Control LQC is performed to verify proper shipping and cartridge storage conditions using various liquid control solutions of known analyte concentration Control materials are commercially available in levels corresponding to normal and abnormal clinical conditions Temperature Test is performed using the IRMA TruPoint Temperature Card to verify proper operation of the IRMA TruPoint temperature control system Al
40. type s in use 1 Highlight Product Setup in the picklist and press edit 2 Highlight each Product Type that will be used at your site Press next to define which analytes will be reported for each cartridge type TEST SETTINGS 4 Lot Entry Calculations v moraran Defining analytes to be reported for each cartridge type Define which analytes will be reported for each CC test 1 Highlight the analytes to be reported automatically with each CC test Press next 2 Ifthe analytes to be reported will vary from test to test highlight User Selects This will prompt individual selection of analytes or analyte groupings with each CC test Press next 7 2 CC Setup User Selects ail back j next CC Setup IL T EE Oe back ON 3 Highlight the button next to the analyte groupings to be displayed for selection with each CC test In the example shown the user would have the choice of selecting ABG pH pCOs pO gt and or Het Lytes Nat Kt CC User Selects Setup ABG Na K ica C back Het fe CO iCa Hct Press next to accept entry and go to setup for the next established product type if applicable Define which analytes will be reported for other cartridge types if applicable 1 The procedure is the same as for CC setup with the exception that there are no analyte
41. 234 highlighted control Press edit and follow the series of entry screens to edit control RET expiration date analytes to be reported for the Wa 143 133 mM control and control limits Deleting a control 1 2 3 4 Press QC on the SETTING OPTIONS menu Press Controls on the QC SETTINGS menu Highlight the button next to the product type of choice Press next The Controls screen displays a picklist of current controls Highlight the control to be deleted Press delete A screen appears to verify the deletion request for the selected control Press ok to delete the selected control The screen returns to the Controls screen The control is deleted but associated QC results remain in the analyzer memory Results for a deleted control may be recalled only via the Search All option not by control lot number USER ID SETTINGS The analyzer can maintain a maximum of 600 User IDs Each ID can be from 1 to 16 alpha numeric characters in length QA Users can access User ID Options by pressing User ID from the SETTING OPTIONS menu A picklist with following options is presented UserID User ID can be turned on or off and configured to appear Add User New User IDs can be added to User 1D Options analyzer memory and granted usn a privileges from one of 3 categories Ete Y eat QA Users General Users or Gluc done Strip Users on IRMA TruPoint results printout
42. 4 98 arterial 1 60 85 venous 2 tHb 11 0 14 5 g dL or 6 9 9 1 mmol L 2 9 years 12 0 15 0 g dL or 7 5 9 4 mmol L 9 12 years 11 7 17 4 g dL or 7 4 10 9 mmol L 12 74 years male 11 5 16 1 g dL or 7 2 10 1 mmol L 12 74 years female MDRD GFR Age Years Average GFR 20 29 116 mL min 1 73 m 30 39 107 mL min 1 73 m 40 49 99 mL min 1 73 m 50 59 93 mL min 1 73 m 60 69 85 mL min 1 73 m 70 75 mL min 1 73 m REFERENCES 1 Tietz NW Clinical Guide to Laboratory Tests 4th ed 1995 2 Wallach J Interpretation of Diagnostic Tests A Handbook Synopsis of Laboratory Medicine 3rd ed 1978 3 Tietz NW Fundamentals of Clinical Chemistry 5th ed 2001 4 Coresh J Astor B Greene T Eknoyan G Levey A Prevalence of chronic kidney disease and decreased kidney function in the adult US population Third national health and nutrition examination survey Am J of Kidney Disease 41 1 1 12 This page intentionally blank B 12 Appendix C Principles of Operation This appendix describes the measurement technology of the IRMA TruPoint blood analysis system MEASUREMENT TECHNOLOGY The IRMA TruPoint system utilizes potentiometric amperometric and conductimetric measurement methodologies to measure the analyte concen tration in whole blood as described in the following table Sensor reference pH pCO NaF K CT iCa BUN urea pO hematocr
43. 6 1 05 0 011 1 0 14 1 05 0 013 1 2 D 5 Level 3 15 153 1 1 6 1 1 15 152 3 1 8 1 2 Level 3 15 5 74 0 103 1 8 15 5 76 0 098 1 7 Level 3 15 0 52 0 008 1 6 15 0 52 0 014 2 8 Level 4 14 130 8 2 3 1 8 15 131 3 2 1 1 6 Level 4 14 6 03 0 105 1 7 15 6 06 0 106 1 8 Level 4 14 1 01 0 020 2 0 15 1 00 0 027 2 7 PRECISION CONTINUED Ck Day 1 Number of samples Mean mM SD CV Day 2 Number of samples Mean mM SD CV Het Day 1 Number of samples Mean PCV SD CV Day 2 Number of samples Mean PCV SD CV BUN Day 1 Number of samples Mean mg dL SD CV Day 2 Number of samples Mean mg dL SD CV Level 1 15 30 5 0 72 24 14 30 4 0 65 2 1 Level 1 14 38 8 1 17 3 0 15 37 8 0 97 2 6 Level 1 15 17 6 1 76 10 0 15 17 1 1 25 73 D 6 Level 2 15 56 9 0 36 0 6 15 57 1 0 24 0 4 Level 2 16 22 7 2 52 11 1 14 22 4 1 57 7 0 Level 2 15 34 3 2 77 8 1 15 33 8 2 09 6 2 Level 3 14 86 6 1 2 14 14 85 8 1 6 1 9 Level 3 14 46 9 1 16 2 5 15 47 2 1 31 2 8 Level 3 14 64 7 3 82 5 9 15 67 9 2 63 PRECISION CONTINUED Glu Day 1 Number of samples Mean mg dL SD CV Day 2 Number of samples Mean mg dL SD CV Day 3 Number of sample
44. Enter the following information when the Gender screen appears gt Select Male Female or skip the GFR Gender Press next foal rome Skip GFR Next gt If a gender is selected then enter age in years Enter Age in Years Press next e w DDDDDOQO ODDDDD J 2 14 Patient Temperature The Patient Temperature option allows entry of a patient temperature when performing a blood gas test A default temperature of 37 C auto matically displays if a patient ID is not entered 37 0 C Oo D9999 9DDIDQYQQ or no previous blood gas results exist for a patient ID Press next to accept the temperature displayed or enter a new temperature and press next Patient Hemoglobin The Patient Hemoglobin manual entry feature allows entry of a hemoglobin value to be used in the BEb calculation when running a blood gas test Press next to accept the hemoglobin value displayed or enter a new value and press next Reference Range The Reference Range feature allows documen tation of the reference range group selected Select the reference range group and press next Sample Type e The Sample Type feature allows documentation of the sample type collected Press next to accept the sample type displayed or enter a new type and press next Sample Site e The Sample Site feature allows documentation of the sample site Press next to accept the sample site displayed enter a new site or select o
45. IRMA TruPoint Blood Analysis System User Manual ITC Technical Support 1 800 631 5945 Press 2 1 732 548 5700 Press 2 ITC Customer Service 1 800 631 5945 U S Press 1 1 732 548 5700 outside U S This manual is published by International Technidyne Corporation ITC for use with the IRMA TruPoint Blood Analysis System Version 7 1 or above Questions or comments regarding the contents of this manual can be directed to the address at the bottom of this page or to your ITC representative IRMA and IRMA TruPoint are registered trademarks of ITC Copyright 2008 This document is the copyright of ITC and must not be copied or reproduced in any form without prior consent ITC reserves the right to make technical improvements to this equipment and documentation without prior notice as part of a continuous program of product development EC REP a Rev 5 441116 1010 This page intentionally blank Table of Contents Section Page 1 The IRMA TruPoint Blood Analysis System 1 1 Introduction Intended Use System Overview CLIA Complexity Classification Implementation System Components System Major Components IRMA TruPoint Blood Analyzer IRMA TruPoint Battery Charger and Power Supply IRMA TruPoint AC Power Adapter IRMA TruPoint Cartridges Getting Started Unpack and Inspect the System Bring the Analyzer to Room Temperature Assemble the Charger Charge the Battery Unpack the IRMA Tru
46. NGS OPTIONS menu QA Users can configure IRMA TruPoint to automatically receive settings profile updates or updates may be sent manually e Automatic Device Updates available settings profile updates as well as available software and or language updates are automatically transferred to IRMA TruPoint when downloading test results to idms Following IRMA TruPoint software upgrades DeviceSet automatically restores settings in the IRMA TruPoint that would otherwise revert to factory default settings e Manual Device Updates QA Users can manually request updates from DeviceSet via the IRMA TruPoint SETTING OPTIONS menu DeviceSet Setup Refer to Section 7 DeviceSet for automatic update setup instructions Refer to the DeviceSet User Manual for DeviceSet instructions Initiating a Manual Device Update QA Users may initiate a manual device update as follows 1 Upload any unsent results to idms or a host system 2 Press the DeviceSet button on the SETTING SETTING OPTIONS OPTIONS menu Menu bad DeviceSet User ID 1 20 3 a If the Communications Method setting is Communications Method User Selects highlight the button next to mu een the appropriate method and press next and Intornat Modom go to step 4 m J b If the Communications Method setting is not User Selects go to step 4 Connect cable to computer and verify that Device Update receive onnec alt DeviceCom is running Select an opti
47. OINT CARTRIDGES Each IRMA TruPoint cartridge contains a sensor array and self contained calibrant One patient or liquid QC test is performed on each cartridge Figure 1 5 A Cartridge Leads electronically connect the cartridge to the analyzer B Luer Injection Port where the sample collection device attaches to the cartridge C Sensors measure analyte concentrations D Calibrant Gel covers the sensors and is used to calibrate the sensors E Temperature Monitoring Site Internal where IRMA TruPoint IR probe measures and controls sample temperature F Enzyme Pad may be present on cartridges that employ enzymatic methodologies G Overflow Indicator alerts user that the maximum sample volume 5 mL that the cartridge can hold has been reached H Waste Reservoir holds a maximum sample volume of 5 mL Air Vent located on the bottom left side of the waste reservoir J Cal Cap contains calibrant for cartridges with enzymatic sensors 0000000000000000 arem m oA gt T a CC Cartridge H4 Cartridge 1 6 GETTING STARTED UNPACK AND INSPECT THE SYSTEM Verify that all components have been received and inspect components for shipping damage Immediately report any shipping damage to your service provider Retain one set of packaging materials Analyzers requiring service by the manufacturer must be returned in the original packaging materials If the original packaging mate
48. Point Cartridges Cartridge Storage and Equilibration Procedure Cartridge Temperature Operating Range Insert Charged Battery or AC Adapter into Analyzer System Features and Setup Main Menu Access Alternate Languages IRMA TruPoint Touchscreen Interface System Security System Setup System Features Bar Code Reader VueLink Device Communication Utility DeviceCom DeviceSet 1 1 1 1 Section 2 Patient Sample Analysis Overview Sample Requirements Acceptable Specimens Syringe Requirements Capillary Requirements Sample Size General Sample Collection Guidelines Blood Gas Sample Handling Electrolyte Glucose Lactate Sample Handling Preparing the Sample for Injection Sample Injection Injecting a Syringe Sample Injecting a Capillary Sample Patient Test Procedure Performing a Patient Test Test Information Entry Entering Test Information Test Information Entry Miscellaneous Oxygen Therapy Information Entry Entering Oxygen Therapy Information Oxygen Therapy Entry Miscellaneous Patient Bypass Status Selecting Patient Bypass Status Patient Notes Entering Patient Notes QC Lockout Satisfying QC Lockout General Rules QC Lockout Screens References Section 3 Quality Control Testing Overview IRMA TruPoint Quality Control Quality Control Recommendation Run an EQC Test Run Two Levels of Liquid Control Additional Liquid Control Testing Run a Temperature Test Electronic Quality Co
49. Siggaard Andersen formula BEb 0 5 8a 0 919 0 5 0 919 8a 4 24 47 HCO3 5 33 1 2 a a a gt a 0 00404 0 000425 x Hb gt HCO3 5 33 0 230 x 5 33 x antilg pH st 6 161 0 9524 gt pH st pH 1g 5 33 pCO gt x pH Hb pH lg pCO gt Hb 1g 7 5006 x pCO gt gt pH Hb 0 0406 x Hb 5 980 1 920 x antilg 0 16169 x Hb gt 1g pCO gt Hb 0 017674 x Hb 3 4046 2 12 x antilg 0 15158 x Hb Base Excess of Extracellular Fluid Base excess of extracellular fluid BEecf also called in vivo base excess or standard base excess is a quantity that reflects only the non respiratory component of pH disturbances Two formulas are available for the calculation of base excess Severinghaus NCCLS or Siggaard Andersen Refer to Section 7 Calculations for instructions on formula selection Severinghaus NCCLS formula BEecf HCO3 24 8 16 2 pH 7 4 Siggaard Andersen formula BEecf BEb for Hb 3 mmol L C 4 Oxygen Saturation Oxygen saturation OSat is the amount of oxyhemoglobin in a solution expressed as a fraction of the total amount of hemoglobin able to bind oxygen oxyhemoglobin plus deoxyhemoglobin The IRMA TruPoint analyzer calculates oxygen saturation from a measured pO and an assumed oxyhemoglobin dissociation curve These results differ significantly from direct measurement Clinically significant errors can result from incorporation of
50. a biohazard container e Collection device and cartridge may have to be separated before disposal if small medical waste containers are used Olen SAFETY PRECAUTIONS Do not place metallic objects on or near the battery charger electrical shock or charger damage could result e Do not immerse the analyzer battery or battery charger in water or any other liquid e Use only ITC batteries with the IRMA TruPoint analyzer Do not operate the battery charger if the power cord or plug is damaged e Prevent liquid cleaning solution from entering the battery charger or analyzer battery compartment e Disconnect the battery charger before cleaning to prevent accidental shock e Do not allow battery contacts to touch metal objects e Battery charger is not intended for use in immediate patient vicinity REFERENCES 1 National Committee for Clinical Laboratory Standards NCCLS Percutaneous collection of arterial blood for laboratory analysis Document H11 A 1985 2 Effects of diseases on clinical laboratory tests Clinical Chemistry 1980 6 4 3 McMahon et al A Comparison of Conductivity Based Hematocrit Determinations With Conventional Laboratory Methods in Autologous Blood Transfusions ANESTH ANALG 1990 71 541 4 4 Henry et al Clinical Diagnosis and Management by Laboratory Methods 16th ed Philadelphia PA W B Saunders and Co 1983 A 6 Oesch et al Ion Selective Electrodes for Clinical Use C
51. a test e Optional A patient ID may be entered when a test is run but is not required to be entered 1 Highlight Optional button and press next 2 Enter the minimum number of characters that must be entered if a patient ID is entered between 1 and 20 characters Press next 3 Enter the maximum number of characters that may be entered if a patient ID is entered between and 20 characters Press next Required Entry of a patient ID is required 1 Highlight Required button and press next 2 Enter the minimum number of characters that must be entered between 1 and 20 characters Press next 3 Enter the maximum number of characters that may be entered between 1 and 20 characters Press next Patient temperature There are 2 patient temperature options e Off No patient temperature may be entered with a test e On A patient temperature may be entered with a test and temperature corrected results will be reported Sample type sample site There are 2 sample type and sample site options e Off No sample type or sample site information may be entered with a test e On Sample type and or sample site information may be entered with a test Patient notes QC notes There are 2 patient notes and QC notes options e Off No patient or QC notes may be entered with a test e On Patient or QC notes may be entered with a test 7 7 Setting up Patient Notes 1 Turn Patient Notes on and pressnext Pati
52. adjustment press edit pe Barometzic Pressure and enter the value from the reference 738 mmn Ce barometer IRMA TruPoint accepts values DAOOQG from 350 900 mmHg Save the value entered ODODOQQQL by pressing next Note e The IRMA TruPoint barometer was calibrated at the factory and should read within 5 mmHg of a NIST calibrated barometer Use of a non NIST traceable reference barometer to adjust the IRMA TruPoint barometric pressure reading is not recommended 7 22 COMMUNICATIONS QA Users can establish the bi directional IRMA TruPoint communications methods for the transfer of IRMA TruPoint test results to the Integrated Data Management System idms or a host system e g LIS HIS and the transfer of device updates from DeviceSet to IRMA TruPoint analyzers Communications methods Enter the modem feature code 663366 and 3 iBnter pentue Code press next 663366 ancor Turn the internal modem on and press done DOODO i OD9990 J Note Internal Modem Not all IRMA TruPoint analyzers are equipped with an internal modem Contact your service provider if you have questions about your done Serial Port An RS232 serial port is located on the backside of the IRMA TruPoint analyzer below the printer A double ended RJ45 crossover cable and cable adapter are available from your local service provider The cable adapter allows the cable to be connected to a computer com port Note External serial se
53. allows pre defined notes to be permanently associated with individual QC test records Up to 3 notes can be attached to an individual QC test record If the QA User enabled QC Notes a notes button will be present on the Results screen Press the notes button to access the pre defined notes available for selection Use the up and down arrows to highlight the desired note and press the check box button Repeat for additional notes and press next when complete Obtain a Printout optional 24 a If the Auto print setting is immediate test results will automatically print when the analysis is complete b If the Auto print setting is delayed test results will automatically print when the done button is pressed from the QC Test Results screen O If the Auto print setting is off a printout may be obtained by pressing the print button 3 12 TEMPERATURE TEST PERFORMING A TEMPERATURE TEST Turn IRMA TruPoint Analyzer On 1 Touch the right hand edge of the screen to turn the analyzer on Do NOT insert a cartridge to power on the analyzer Note e All QC tests must be initiated via the main MENU QC Test option Ifa cartridge is inserted to power on the analyzer or inserted at the main MENU screen the analyzer will automatically initiate a patient test not a QC test Enter User ID optional 2 If the User ID option has not been activated go to step 4 3 If the User ID option i
54. ample alternating syringe orientation until thoroughly mixed Check the expelled sample for blood clots A clot usually indicates inadequate sample anticoagulation e g the sample and heparin were not well mixed If a clot is injected near or over the cartridge sensors erroneous test results or sensor errors could occur Do not use clotted samples When using the IRMA TruPoint Capillary Collection Device analyze the sample immediately or place a luer cap on the tip of the device and analyze within 5 minutes 2 3 SAMPLE INJECTION With each test the cartridge automatically calibrates before the sample is injected into the cartridge Following calibration the calibrant that is present in the sample path must be completely displaced by the blood sample that is being analyzed The sample path is the area of the cartridge that houses the sensors and must be completely filled with blood see Figures 2 2 and 2 3 Proper sample injection technique will ensure that the calibrant is completely displaced and that no air bubbles are introduced during the injection step If calibrant or bubbles are present in the sample path following the initial sample injection from a syringe the user can displace them by injecting additional sample from the same syringe This prevents sensor errors and sample loss INJECTING A SYRINGE SAMPLE The following injection technique should be used for all syringe samples regardless of syringe size o
55. an upper and lower limit for each control lot level and analyte The limits are reported on the analyzer printout with each associated test available through result recall and can be transferred via the ASTM output to the idms QC Lockout Allows optional definition of requirements number of tests per level per shift for both electronic and liquid QC that must be met before the analyzer can be used for patient testing Reference Ranges Allows ability to define reference ranges and provide an optional entry of an upper and lower reference limit for each analyte by sample type and a reference range title When activated patient test results that fall outside of the defined limits will be flagged H High or L Low The ranges are reported on the analyzer printout with each associated test and sample type Reference ranges are stored with the results at the time the test is performed therefore changes can be made to the limits without affecting previous results Reportable Ranges Allows optional entry of user defined upper and lower reportable range limits for each analyte User defined reportable range limits must be within the default IRMA TruPoint reportable range limits Results Transfer Enables transfer of new or previously transferred results via the serial port LAN 10 100 port or the internal or external modem utilizing ASTM standard format and communication protocols Sample Type Site Allows optional selection o
56. as out Press quit to power off analyzer Call damaged AC adapter of range your service provider for assistance 5 6 SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION ANALYZER MEMORY Attention Approaching result capacity WARNING Reached result capacity Patient EQC LQC or Temperature Test was selected and the analyzer memory was within 20 records of being full Message will display only if results transfer is on If Auto EQC is on the message will display when the analyzer exits sleep mode Patient EQC LQC or Temperature Test was selected and the analyzer memory was full Stored results will be overwritten Message will display only if results transfer is on If Auto EQC is on the message will display when the analyzer exits sleep mode Press ok to continue test Following completion of the test transfer stored data if stored results should not be overwritten See Section 4 Data Access Once storage capacity is reached analyzer will begin to overwrite stored results A Press cancel to abort test if stored results should not be overwritten Transfer data before continuing B Press ok to continue the test results that have not been transferred may be overwritten 5 7 SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE DATA TRANSFER Unable to Transfer No test results to upload Unable to Transfer Tra
57. available liquid control solutions Typical precision was observed as follows pH Level 1 Level 2 Level 3 Day 1 Number of samples 15 15 15 Mean 7 228 7 416 7 631 SD 0 007 0 005 0 011 CV 0 1 0 1 0 2 Day 2 Number of samples 15 15 15 Mean 7 228 7 414 7 625 SD 0 006 0 005 0 008 CV 0 1 0 1 0 1 pco Level 1 Level 2 Level 3 Day 1 Number of samples 15 15 15 Mean mmHg 70 7 38 5 17 7 SD 22 1 7 0 7 CV 3 1 43 3 7 Day 2 Number of samples 15 15 15 Mean mmHg 71 4 39 1 18 1 SD 3 4 0 7 0 5 CV 47 1 7 2 8 pO Level 1 Level 2 Level 3 Day 1 Number of samples 15 15 15 Mean mmHg 71 9 99 4 163 8 SD 2 9 1 9 2 3 CV 4 0 1 9 1 4 Day 2 Number of samples 15 15 15 Mean mmHg 70 9 101 1 165 9 SD 2 4 1 6 2 1 CV 3 3 1 6 1 3 D 4 PRECISION CONTINUED Nat Day 1 Number of samples Mean mM SD CV Day 2 Number of samples Mean mM SD CV Kt Day 1 Number of samples Mean mM SD CV Day 2 Number of samples Mean mM SD CV iCa Day 1 Number of samples Mean mM SD CV Day 2 Number of samples Mean mM SD CV Level 1 14 99 5 1 9 1 9 15 100 6 1 9 1 9 Level 1 14 1 76 0 037 2 1 15 1 79 0 028 1 6 Level 1 14 1 41 0 020 14 15 1 42 0 023 1 6 Level 2 16 120 4 2 9 24 14 120 9 1 6 14 Level 2 16 3 93 0 080 2 0 14 3 96 0 066 1 7 Level 2 1
58. bly 8 Reinstall the two thumbscrews from the bottom of the analyzer while holding the cover in place Do not over tighten the thumbscrews Following installation verify that a cartridge can be inserted into the edge connector Perform an EQC test to verify functionality of the analyzer Note e Do not touch the leads on the edge connector assembly Contamination of the leads can result in EQC failure and or sensor errors 6 8 Section 7 System Settings OVERVIEW This chapter provides setup instructions for all IRMA TruPoint system settings SETTING OPTIONS MENU System settings are configured through the SETTING OPTIONS menu Access to Setting Options is controlled by User ID privilege e QA Users have access to all system settings menus e Non QA Users have limited access to the device settings menu only Access the SETTING OPTIONS menu by pressing the Settings button on the main MENU The following options are presented Menu Returns to main MENU SETTING OPTIONS DeviceSet Appears only with entry of QA User s ID Initiate device update from Doviesset sald DeviceSet Tost device Test Advances to TEST SETTINGS menu Access setup screens for product setup product lot entry calculations test information correlation bypass correlation display units reportable ranges and reference ranges Qc Advances to the QC SETTINGS menu Set up or modify liquid controls and
59. calibrant and press next The calibrant must be dispensed within 1 minute or the test is terminated and an Error message appears 17 If the QA User enabled the test information Yj oxygen therapy information and or bypass a status features buttons will appear on the Calibrating and Analyzing screens ca Information may be entered during calibration Refer to Section 2 Test Information Entry for instructions Remove Luer Cal Cap Inject Blood Sample and Press test 18 The Calibration Complete screen displays Calibration Complete when calibration is complete Twist and lift Lemana meat J the luer or Cal cap to remove it from the 2 Inject sample injection port The sample must be injected Eeg ees cm within 4 minutes of completing calibration A timer displayed at the bottom of the screen counts down from 4 minutes If more than 4 minutes elapse the test is terminated and an Error message appears ote e If an Error screen appears during calibration refer to Section 5 Troubleshooting for assistance 19 Inject 0 125 mL IRMA TruPoint Capillary Collection Device or 0 2 5 0 mL syringe of blood into the cartridge within 4 minutes after the cartridge is calibrated Leave the collection device attached to the cartridge Refer to Section 2 Injecting a Syringe Sample or Section 2 Injecting a Capillary Sample for sample injection details 2 10 Note e If air bubbles or calibrati
60. canner YVIVID wy a Entry via touchscreen keypads enter your User ID and press next b Entry via bar code scanner scan your User ID The IRMA TruPoint display will automatically advance to the next screen 2 Scan cartridge bar code A screen instructing you to Scan cartridge bar code will display at Sean cartridge bar the appropriate time Scan the cartridge I Patient Test package label for the cartridge to be used Note To manually enter and or verify cartridge information press manual entry a Successful scan cartridge product type Lot Code and Cal Code will be accepted The IRMA TruPoint display will automatically advance to the next screen the Select Product Type and Verify Information screens will not be displayed b Scanning Error the Scanning Error anabe BOE message will be displayed The cartridge Be sel ter oe bar code may be re scanned or the user may press manual entry to manually enter and or verify product type Lot Code and Cal Code VUELINK Please contact your local representative regarding the current availability of Vuelink Description The Philips Agilent VueLink module is a component for Philips Agilent patient monitors VueLink allows IRMA TruPoint patient test results to be transmitted to the Philips Agilent patient monitor for display VueLink Setup Refer to Section 7 VueLink for IRMA TruPoint VueLink setup instructions Patient ID sh
61. capillary tube but most users find it easier to collect the sample with the plunger out of the barrel If the plunger is out of the barrel during sample collection insert it into the barrel after sample collection is complete Do not force the plunger against the white plug when inserting the plunger the plunger tip should rest against the white plug but should not move the plug Select prepare and puncture the collection site according to your facility s protocol Remove the first drop of blood from the site with gauze and touch the tip of the device to the site to begin filling Hold the capillary tube at a horizontal or slightly downward angle during collection Allow the capillary tube to fill completely via capillary action If bubbles are present in the sample channel remove them by angling the tip downward and allow the sample to flow back towards the tip to push the air bubble out the tip or blot sample from the device Refill the device with additional sample Remove air bubbles or voids before the sample contacts the white plug Once the sample contacts the white plug the device will stop filling and air can no longer be removed When blood contacts the white plug the device is completely filled Do not wipe or blot the tip of the device after filling Doing so may accidentally wick sample from the sample channel resulting in a sample void at the tip Inject the sample into an IRMA TruPoint cartridge a When cartridg
62. charged battery og AC Adapter in use a at If the battery icon disappears the battery should be put through a conditioning charge See Section 6 Conditioning the Battery 6 2 REMOVING THE BATTERY Remove the depleted battery from the analyzer by pressing on the clips located on the sides of the battery Recharge the battery following the procedure in Section 6 Charging the Battery Routine Figure 6 1 Figure 6 1 oo CHARGING THE BATTERY ROUTINE 1 Connect the power supply to the IRMA TruPoint charger and secure the screw on locking mechanism 2 Connect the wall cord to the power supply and plug the wall cord into an electrical outlet 110 VAC 60Hz or 220 VAC 50Hz 3 Insert the battery into the battery charger The battery should click into the charger when properly inserted The yellow light indicates that the battery is charging 4 The green LED on the charger will begin to blink blinks for 30 seconds off for 4 seconds blinks for 30 seconds etc when the battery is at approximately 90 capacity When the battery is at 100 capacity the green light blinks continuously Batteries should remain in the charger until the green LED blinks continuously 5 Leave a fully charged battery in the charger until it is needed for use The charger will continue to top off a fully charged battery ensuring that it is at 100 capacity when needed for use in the analyzer Cau
63. collection device attached Dispose of both in accordance with established guidelines for your facility View Test Results 22 Results automatically appear on the IRMA TruPoint touchscreen when the analysis is complete Press more to view additional measured or calculated results if all the results do not appear on the screen 2 11 a Result outside of reference range If Rae reference ranges were established by the a roa ETA notes QA User and a patient test result falls m Bet wary outside of the defined limits the result will m ICa isomu sone be flagged H High or L Low b Result outside of reportable range If a ee measured result is outside of the IRMA 2 roz one r cd TruPoint reportable range that result and et cone any corresponding calculated results will more Jia Lasem Sone be flagged lt less than or gt greater than c Result suppressed If a sensor errors pva A during the analysis phase of a patient test Poz aoim the result for that sensor any sensors vt ret dependent on that sensor and any wore ica tase ome corresponding calculated values will be suppressed Suppressed results will be dashed out on both the screen and printout ote e pH Normalized iCa results will be reported only for pH values within the range of 7 2 7 6 if pH values fall outside of this range pH Normalized iCa results will be suppressed Complet
64. controls controls 42 have already been defined Lot expired Expired cartridge lot was Use an in date cartridge lot entered via Test Settings QC Test or Patient Test DEVICESET UPDATE Unable to Transfer Low Battery Communication Error Verify connections and receiving system Insufficient battery power to begin device update Data transfer between the analyzer and receiving system was unsuccessful Press quit to power off analyzer replace the battery with a freshly charged battery 1 Verify that receiving system is ready e g DeviceCom is running 2 Verify that cables and adapters are properly connected to both the IRMA TruPoint and receiving system Use cables and adapters supplied by your service provider 3 Verify that transfer cable is connected to correct com port specified in DeviceCom setup 4 If transferring serially ensure that the IRMA TruPoint and receiving system baud rates match If the analyzer is configured to transfer to idms the receiving system must be set to a baud rate of 19200 If the analyzer is configured to transfer to host the receiving system must be set to a baud rate of 9600 5 If transferring by the LAN 10 100 make sure that the network settings are correct See Section 7 Communications 5 9 This page intentionally blank 5 10 Section 6 Maintenance OVERVIEW This chapter describes the routine and preve
65. ct Product Type screen O Go next b Auto EQC Printout The auto EQC report Ante BGO Petatoats can be printed in a detailed full or mw Qe abbreviated short report The short report PER cot provides a printout indicating pass or failed EQC For a detailed report press Full and press Short for an abbreviated report c Liquid QC Lockout Select the number of EE AT controls to be run on shift 1 1 2 or 3 one Press next Repeat step to define number of 2 Q controls to be run on each shift Press next to gt O Qa advance to lockout setup for each analyte oo lt CONTROLS QA Users can set up liquid controls for each product type The analyzer will store a maximum of 42 individual control entries for cartridge product types Once this limit is reached an existing control must be deleted before a new control can be added 7 17 QC limits may be entered into the analyzer for each control optional These limits are used during quality control testing to verify that the analysis system is performing properly QC results will be flagged only when limits are defined Setting up a new control 1 2 3 10 Press QC on the SETTING OPTIONS menu Controls Level 1 53023 a aaa Press Controls on the QC SETTINGS menu E ABG Hct Na K iCa limits D aone The Controls screen displays a picklist of current controls Press add for a new control Highlight the product type
66. ction 6 Charging the Battery Routine for detailed battery charging information Leave a fully charged battery in the charger until it is needed for use The charger will continue to top off a fully charged battery ensuring that is at 100 capacity when needed for use in the analyzer 6 1 e Perform a conditioning charge monthly or more frequently as the schedule allows A conditioning charge will help ensure optimal battery performance If a battery must be removed from the charger before it is completely charged the battery should go through a conditioning charge to restore optimal performance Note e NiMH batteries PN 448700 must be charged in a NiMH charger PN 442900 They are not compatible with the old nickel cadmium NiCad charger PN 423200 Charge Times and Test Yields e NIMH batteries take 5 5 10 hours to fully charge and yield approximately 30 40 tests Battery Life The rechargeable batteries should retain expected performance characteris tics for 500 charge cycles Touchscreen Battery Icon A battery icon displays in the upper right corner of all screens except the patient test and QC test screens A dark meter bar in the battery icon represents the battery capacity oe Battery NiMH at 100 capacity Battery at 50 capacity Battery at 0 capacity A flashing battery icon with no meter bar present represents an empty battery The battery should be replaced with a fully
67. d 10 000 and press next 3 Enter intercept value between 999 00 and 999 99 and press next 7 11 DISPLAY UNITS QA Users can designate the units of measure for barometric pressure temperature and analyte concentration using the Display Units option Defining units of measure 1 Highlight Display Units from TEST TEST SETTINGS SETTINGS and press edit Bypass correlation At 2 Highlight the test parameter of choice from the a picklist and press edit 3 Select the desired unit of measure and press next 4 If multiple parameters were selected select desired units for each parameter pressing next from each screen until complete REFERENCE RANGES QA Users can establish a reference range consisting of an upper and lower limit for each analyte by patient and sample type and a title description of the range An out of range patient test result will be flagged H High or L Low on the printout and the result will flash on the touch screen Reference ranges used at the time of a test are permanently stored with the results Reference ranges can be changed without affecting the ranges associated with previous results Type specific reference ranges can be established by patient and analyte for each sample type Setting up reference ranges 1 Highlight Reference Ranges from the TEST TEOT serrmes SETTINGS menu Press edit ea 4 Reportable Range v eat Master On Type Specific Ott done
68. d and Derived Quantities with Modern pH and Blood Gas Equipment Calculation Algorithms with 54 Equations in Scandinavian Journal of Clinical amp Laboratory Investigation 48 Suppl 189 7 15 12 Siggaard Andersen O The Acid Base Status of the Blood 4th ed 1974 13 Malley WJ Clinical Blood Gases Application and Noninvasive Alternatives Ist ed 1990 14 Anderson SC Cockayne S Clinical Chemistry Concepts and Applications 1st ed 1993 15 Burtis CA Ashwood ER eds Tietz Fundamentals of Clinical Chemistry 5th ed 2001 C 7 This page intentionally blank C 8 Appendix D Performance Characteristics ACCURACY Accuracy was determined by analyzing human whole blood samples on both the IRMA TruPoint blood analysis system and a reference method Least squares analysis was used to determine the line of best fit pH Number of samples Range evaluated Slope Intercept Correlation Coefficient r Sy x pCO Number of samples Range evaluated mmHg Slope Intercept Correlation Coefficient r Sy x pO Number of samples Range evaluated mmHg Slope Intercept Correlation Coefficient r Sy x Sodium Na Number of samples Range evaluated mM Slope Intercept Correlation Coefficient r Sy x 94 6 860 7 710 0 936 0 456 0 997 0 017 94 4 4 149 4 0 972 0 308 0 999 1 88 94 17 9 356 5 0 996 1 494 0 999
69. d complete entry 2 n oxygen _ me OG gt If Pump status is selected press next to access the FIO screen Enter FIO value and press next to access Comments screen Enter a one to twelve character comment optional and press next to complete entry gt If the Oxygen status is selected press next to access the Oxygen Therapy screen Oxygen Therapy Highlight the appropriate Oxygen Therapy mode Press next D Vont The entry options displayed depend on the om relevant settings for the selected oxygen Oxygen Therapy g2 pees cpap a m C a therapy mode Ventilator Mode The Ventilator Mode screen appears following selection of Vent from the Oxygen Therapy screen Highlight the appropriate mode and press next Ventilator 2 simv 2 AC Mode BIPAP 2 rv ODC The following information may be entered depending upon the ventilation mode selected v v v v v gt Tidal Volume mL Rate or Frequency B min FIO PEEP cm H20 IPAP cm H20 EPAP cm H20 Comments up to twelve alpha numeric characters Mask Type The Mask Type screen appears following selection of Mask from the Oxygen Therapy Mask Type D Simpie screen Highlight the appropriate mask type and D hani press next Dia come O C wisn Flow oe 2 17 The following information may be entered v If Venturi Trach Collar or High Flow
70. dered a successful test and satisfy QC lockout requirements 7 15 When NO liquid QC limits have been established running the designated number of controls will satisfy QC lockout requirements for all non suppressed results If an individual sensor on a cartridge errors during the analysis phase of an liquid QC test the result for that sensor and any other sensors that are dependent on that sensor will be suppressed Suppressed results will be dashed out on both the screen and printout and will not satisfy QC lockout requirements for the associated analyte group with or without QC limits established If a patient test is initiated and QC Lockout is on and Lockout requirements have not been met a lockout information screen displays Refer to Section 2 QC Lockout Screens for details on QC Lockout screen messages Automatic EQC When the IRMA TruPoint analyzer is being operated with the AC adapter EQC may be configured to run automatically according to a predefined EQC lockout schedule When due an EQC test will automatically run 15 seconds after the analyzer goes into sleep mode i e after analyzer screen backlight turns off following 2 minutes of inactivity All of the general QC lockout rules apply to auto EQC See Section 3 for more information Activating or deactivating QC lockout 1 Press QC Lockout on the QC SETTINGS y2 Seleet Product Type menu The Select Product Type screen rac A rimt di
71. e e IRMA TruPoint generates an error if the calibration code is not verified within approximately 2 minutes of cartridge insertion Select Analytes 13 Ifthe QA User set up the analyzer to always automatically report results for a specified group of analytes the Select Analytes screen will not appear the analytes defined in the setup will always automatically be reported Proceed to step 16 14 If the QA User set up the User Selects iE Select analytes option for the product being run the Select Analytes screen will appear with each test je e s 15 Select the analytes or analyte groups to be tested by highlighting the appropriate button s Press next when all desired analytes have been selected Note e Analytes that are locked out will have a padlock over the selection button preventing Select Analytes selection of that analyte until QC Lockout requirements have been satisfied Calibration 16 Once the required data has been entered or verified the calibration process begins 2 9 a For cartridges that have calibrant gel packaged over the sensors CC BG H3 calibration begins automatically Proceed to step 17 b For cartridges that have a Cal Cap H4 GL CR LA when the Dispense Calibrant screen displays with countdown timer at bottom follow the on screen instructions for dispensing the calibrant over the sensors Depress the Cal Cap firmly and quickly to dispense the
72. e Automatic Device Updates as follows 1 Highlight the on or off button and press Automatic Results Transfer next to setup the Automatic Results Transfer cance feature next Note e QA Users can manually request updates from DeviceSet via the IRMA TruPoint SETTING OPTIONS menu DATE FORMAT There are 3 date format options eae reat MM DD YY cancel e MM DD YY Month Day Year YY MM DD C e YY MM DD Year Month Day poymmvy C Qa e DD MM YY Day Month Y ear 1 Highlight the desired date format Press next DATE TIME The date and time are appended to each patient and QC test record error and printer output 1 Enter the current Date using the previously jie pate ioy established format Entry of the backslash 11 22 04 C is required for a valid date format DAOOOQ OOOO OS maul 2 Enter the current Time in the format hh mm ae and select the appropriate label by pressing 14 21 OODCA am pm or 24h Entry of the colon is DIODOQ required for a valid time format Only QA DSO C users have the privilege to edit a date All other users can change the time 7 27 AUTO PRINT There are 3 auto print options e Off Test results do not automatically print upon completion of sample analysis A printout may be obtained by pressing the print button on the Results screen e Immediate Test results and sample information entered during the tes
73. e Section 6 Maintenance Remove the printer door Check printer for a paper jam See Section 6 Maintenance Verify that the printer option is activated in instrument set up See Section 7 System Settings Call your service provider INCONSISTENT TEST RESULTS e General e Patient Test Results e Liquid QC Test Results we N W Ne W 5i Verify that the cartridge has not been out of the package more than 15 minutes Verify that the cartridges have equilibrated to room temperature for the recommended time following removal from shipping cartons See Appendix B Table B 7 for equilibration requirements Run an EQC test to verify that the analyzer is operating properly Verify that the barometric pressure reading is correct Review the above corrective actions general Draw another sample and repeat patient test with a new cartridge Rule out preanalytical errors See Section 2 Sample Requirements Verify that injection technique is correct See Section 2 Sample Injection Call your service provider Review the above corrective actions general Verify that the room temperature has not shifted some analytes are temperature sensitive in liquid solutions Verify that injection technique is correct See Section 2 Sample Injection Review QC sample handling recommendations see Section 3 Liquid Quality Control and repeat the test with a new control ampule Call
74. e Test Information Entry optional Document Patient Notes optional 23 Refer to Section 2 Test Information Entry and Section 2 Patient Notes for details Obtain a Printout optional 24 a If the Auto print setting is immediate test results will automatically print when the analysis is complete b If the Auto print setting is delayed test results will automatically print when the done button is pressed from the Results screen c If the Auto print setting is off a printout may be obtained by pressing the print button 2 12 TEST INFORMATION ENTRY The Test Information feature allows the user to enter information into the IRMA TruPoint for each patient test The entry options that are available for selection with each test have been established by the QA User and may include any combination of the following patient ID patient temperature patient hemoglobin sample type sample site MDRD GFR calculation and FIO2 When entered this information becomes a permanent part of the patient test record and may be transferred to the idms ENTERING TEST INFORMATION e Press the Test Information button that appears on the Calibrating Analyzing Ej Results or Patient Recall Last Results Te S g Calibrating screens If this button is not present the QA User has not enabled this feature or none of the options apply to the associated test record e The first test information entry
75. e calibration is complete remove the luer cap if applicable from the cartridge Firmly seat the tip into the luer injection port of the cartridge to make an air tight seal The sample may leak if not tightly sealed Figure F 2 b Anchor the device with your IE thumb and index finger right below the square flange of the capillary device Figure F 2 F 3 Figure F 3 c With the index finger of the other hand dispense the sample by quickly depressing the plunger straight down in one smooth motion until it stops Figure F 3 d Verify that there are no bubbles or calibrant present in the sample path and press test If bubbles or calibrant are present press cancel to stop the test discard the single use cartridge and begin again with a new cartridge Proper injection technique will prevent air bubbles or calibrant from being present in the sample path following injection Following test completion dispose of the device and cartridge in accordance with established guidelines for your facility Do not reuse the plunger F 4 Appendix G Software Updates ANALYZER SOFTWARE UPDATES Refer to the ITC Device Communications Utility User Manual and the instructions provided with the software update G 1 This page intentionally blank G 2 Appendix H Warranty LIMITED WARRANTY International Technidyne Corporation the Company warrants the IRMA TruPoint Analyzer Battery Charger a
76. e entries and return to the Calibration Complete Inject Sample screen None of the information screen entries will be saved until next is pressed on the last entry screen Pressing back to return to the Calibration Calibration Complete or Analyzing screens will not save test information entries Oxygen therapy information entry can be resumed and completed during the Analyzing phase of the test After the test is complete Results screen displayed or upon recalling the last patient test result oxygen therapy information may be entered via the Test Information button 2 18 PATIENT BYPASS STATUS The Bypass Status feature when established by the QA User requires the user to select a patient bypass status On Bypass or Off Bypass for each patient test When On Bypass is selected the bypass correlation factors established by the QA User will be used to determine the hematocrit results This information becomes a permanent part of the patient test record and may be transferred to idms See Section 7 Bypass Correlation SELECTING PATIENT BYPASS STATUS Press the patient Bypass Status button heart icon that appears on the Calibrating or Analyzing screens If this button Calmenting is not present the QA User has not enabled this feature or none of the options apply to the associated test record Bypass status can also be selected by pressing the Test Information button that appears on the Results screen follow
77. e the sample e The capillary tube sample channel must be completely filled with blood and contain no air bubbles If the sample channel is not completely filled i e blood is not in contact with the white plug the sample may run out of the device e The presence of bubbles in the sample channel may result in erroneous or suppressed results If bubbles are present in the sample channel remove them by angling the tip downward and allow the sample to flow back towards the tip to push the air bubble out the tip or blot sample from the device Refill the device with additional sample e If using a cartridge with a Cal cap let the sample sit in the capillary tube for one minute following collection before attaching the capillary tube to the cartridge For all other cartridge types analyze the sample immediately following collection or place a luer cap P N 033501 on the tip of the capillary tube to prevent room air contamination Properly label the device and analyze the sample within 5 minutes Do notice samples collected in this device e Use of this device with instruments other than the IRMA TruPoint Blood Analysis System must be validated to ensure proper sample volume and functionality STORAGE Store at room temperature away from direct sunlight F 2 INSTRUCTIONS FOR USE 1 The black plunger comes packaged separately from the capillary tube Samples may be collected with the plunger in or out of the barrel of the
78. ecord and patient ID if applicable are shown below the picklist for the highlighted result The options available from the Results Found screen are a print all Proceeds to the Verify Results to be Printed screen The search criteria previously entered displays with the following options 4 3 Verify Results to be Printed 123456789675 10 22 02 10 29 02 ttt al print Presents the Printing Patient Printing Patient Results Results screen that displays the total number of patient results found and the Te number of the result currently printing aiai sor Printing can be stopped by pressing the stop button and restarted by pressing resume Upon completion of printing the screen returns to the Results Found screen Note e The number of patient test results that can be printed at one time depends on the IRMA TruPoint power source at printing time gt AC Adapter an unlimited number of results can be printed gt Battery up to fifty test results can be printed If there are gt fifty results in the selection set a message prints indicating that the maximum number of records that can be printed at once has been exceeded Select edit to redefine the search dates or cancel to return to the PATIENT RESULTS menu a2 edit Returns to the Search Patient Results screen b view Results can be viewed from the Results Found Results Found screen by highlig
79. elected The Verify Results to be Printed screen displays The options from this screen are v print Sorts results and prints a table Verify Results to be Liquid Cartridge back Control edit CC Li Lot 16738 12 22 04 12 30 04 for all the results that meet the search criteria displayed Printing can be stopped by pressing the stop button and restarted by pressing resume Upon successful completion of printing the system returns to the SEARCH QC RESULTS menu v 4 7 edit Returns to SEARCH QC RESULTS menu gt back Returns to the Output Type screen 3 If no results for the criteria entered are found the Unable to Recall No Results found for the search criteria entered screen displays Press edit to return to the Search QC Results screen or ok to return to the QC RESULTS menu Note e Refer to Section 3 Quality Control of the SureStep Pro Glucose Module User Manual for glucose QC test recall instructions 4 8 RESULTS TRANSFER The Results Transfer feature allows IRMA TruPoint patient and QC test results and associated test information to be transferred to idms or other connected system via the IRMA TruPoint serial port LAN 10 100 internal modem if present or external modem If the QA User has enabled Results Transfer any IRMA TruPoint user can transfer results IRMA TruPoint analyzers can also be configured to automatically transfer test results under certain conditi
80. elphia W B Saunders 1995 4th Ed 2 21 This page intentionally blank 2 22 Section 3 Quality Control Testing OVERVIEW Quality Assurance QA can be defined as the required systems and actions to provide adequate confidence that a service such as a point of care diagnostics program satisfies the medical needs of the patient Quality Control QC is a major component of a QA program and can be defined as the systematic process of assessing and documenting the analytical performance of an analysis system By design a point of care POC system is intended to be used by non laboratory clinical staff who typically do not have a background in the quality control analyzer maintenance and calibration procedures that are inherent components of traditional laboratory analyzer QA programs Traditional laboratory analyzer QC programs are designed to detect system problems primarily through the use of liquid controls System problems are typically related to calibration or maintenance problems that result from the exposure of the system and sensors to multiple samples The IRMA TruPoint system was designed to eliminate problems related to calibration and maintenance Single Use Cartridges The IRMA TruPoint system utilizes single use cartridges also referred to as unit use or disposable cartridges Each cartridge houses miniaturized electrochemical sensors and a pre packaged calibrant A single use cartridge is used to
81. ens will not save test information entries Test information entry can be resumed and completed during the Analyzing phase after the test is complete Results screen or upon recalling the last patient test result OXYGEN THERAPY INFORMATION ENTRY The Oxygen Therapy feature allows the user to enter oxygen therapy information into the IRMA TruPoint for each patient blood gas test Information available for entry includes mode of oxygen therapy and the relevant settings for each mode When entered this information becomes a permanent part of the patient test record and may be transferred to idms ENTERING OXYGEN THERAPY INFORMATION e Press the Oxygen Therapy button that appears on the Calibrating or Analyzing screens If this button is not present Calibrating the QA User has not enabled this feature or Ej none of the options apply to the associated test Ite record Oxygen Therapy information can also vyj be entered by pressing the Test Information button that appears on the Results screen following a test or upon recalling the last patient test result e The first oxygen therapy entry screen will display Enter information or press next to advance to the next entry screen 2 16 Patient Status Patient Status Highlight the appropriate Patient Status setting gt If Code or Room Air status is selected Code press next to accept the selected oxygen Room Air status an
82. ent Notes 2 Default or established patient notes appear in a picklist a Deleting Patient Notes Highlight the lt Patient Notes desired note and press delete aren Y paa Phy Called y delete b Adding Patient Notes Press add and enter a io Entries a new note via the touchscreen keypad a Patient notes may be up to 12 characters in length and a maximum of 15 patient notes may be established Setting up QC Notes 1 Turn QC Notes on and press next 2 Default or established QC notes appear in a picklist a Deleting QC Notes Highlight the desired note and press delete b Adding QC Notes Press add and enter a new note via the touchscreen keypad QC notes may be up to 12 characters in length and a maximum of 15 QC notes may be established CORRELATION QA Users can establish correlation parameters for each IRMA TruPoint product type to adjust IRMA TruPoint patient test results to values that would be expected if samples were run on another analyzer i e designated reference analyzer These correlation factors are based on split sample blood results from a statistically valid number of samples The IRMA TruPoint analyzer can be run without using the Correlation feature even if correlation values have been entered into the analyzer There are 2 correlation options e Off Correlation parameters will not be used by the analyzer to adjust IRMA TruPoint patient test results
83. epPro Glucose Module User Manual for details QC LOCKOUT QA Users can designate the number of QC tests electronic and or liquid QC required to support patient testing Separate QC lockout schedules may be established for each product type and analyte or analyte group When QC Lockout is activated either 1 2 or 3 successful quality control tests must be run during a shift or the analyzer will deny access to the patient test screen Shifts can be specified as 8 12 or 24 hours in length Example An 8 hour shift length and one EQC tests per shift is defined A 1 hour grace period is provided at the start of each shift in which the patient test screens may be accessed even if QC requirements have not been met If the shift begins at 7 a m the grace period is from 7 8 a m After the grace period patient test screens cannot be accessed until a successful EQC test has been run QC must be run after the shift start time established in the set up in this example 7 a m to count toward satisfying the QC Lockout requirement Shift times are based on the analyzer s internal clock General QC lockout rules e When EQC Lockout is on an EQC test failure at any time i e even if EQC passed earlier on the same shift will lockout patient testing Following an EQC test failure a passed EQC test is required to resume patient testing e When liquid QC limits have been established results must fall within the established QC limits to be consi
84. er door With the analyzer on push down on the printer door and slide the door away from the analyzer Figure 6 2 2 Remove old paper roll and spindle Save the spindle 3 Insert new paper roll Insert the plastic spindle through the center of the new paper roll Figure 6 3 6 4 4 Place the spindle into the cradle in Figure 6 4 the paper compartment 5 Feed paper into printer Insert the paper into the feed slot ensuring that the tab is under the roller Use a clean edge or fold corners into a point Press feed Figure 6 4 The paper will automatically stop advancing after being properly fed into the printer IRMA TruPoint Blood Analysis System will print confirming that the paper was loaded correctly 6 Replace printer door The analyzer will return to the last screen that was displayed before the printer cover was removed CALIBRATING THE BAROMETER The IRMA TruPoint barometer should be calibrated annually to maintain analyzer accuracy Use a National Institute of Standards and Technology NIST traceable barometer for calibration See Section 7 Calibrate Barometer Note e The IRMA TruPoint barometer was calibrated at the factory and should read within 5 mmHg of a NIST calibrated barometer Use of a noncalibrated reference barometer to adjust the IRMA TruPoint barometric pressure reading is not recommended Do not calibrate the IRMA TruPoint analyzer baromet
85. er using values derived from a water barometer CLEANING SYSTEM COMPONENTS CLEANING THE TOUCHSCREEN Immediately wipe any spilled liquid off of the touchscreen to prevent buildup of film on the screen Clean the analyzer screen with a soft cloth dampened with isopropyl alcohol a 10 bleach solution or distilled water Dry the screen with a soft cloth following cleaning Caution e Do not use strong detergents concentrated bleach or abrasive cleaning solutions that could scratch or damage the screen Do not use excessive force 6 5 CLEANING THE BATTERY CHARGER POWER SUPPLY AND ANALYZER SURFACES Cli Immediately wipe any spilled blood or other contaminant from the component surface Clean using a 10 bleach or detergent solution Caution Use proper precautions when cleaning blood from the analyzer Do not immerse the battery charger power supply or analyzer in any liquid Unplug the battery charger or power supply before cleaning to prevent electrical shock CLEANING THE BATTERY CONTACTS Periodically examine the battery contacts battery charger contacts and analyzer battery compartment contacts for dirt corrosion or contamination Clean the contacts using a swab moistened with isopropyl alcohol or use a clean pencil eraser Caution Do not immerse the battery in any liquid Unplug the battery charger or power supply before cleaning to prevent electrical shock Keep battery contact
86. ertion If the leads appear dirty or if the Temp Test fails repeatedly clean the leads using a swab moistened with isopropyl alcohol or use a clean pencil eraser Following cleaning ensure that the leads are dry and that no eraser residue is present before inserting the Temp Card into the edge connector The leads should appear shiny when clean 6 7 REPLACING THE EDGE CONNECTOR Replace the edge connector if instructed to do so by your service provider or if it has been contaminated and cleaning does not resolve the problem 1 Remove the power source from the analyzer 2 With the instrument top facing up Figure 6 6 remove the right and left cartridge guides by pulling them straight forward and off of the cartridge insertion porch area Figure 6 6 3 Remove the edge connector assembly by removing the two thumbscrews from the underside of the analyzer directly below the serial number label 4 Lift the edge connector assembly off of the analyzer 5 Make sure that the connector on the analyzer where the edge connector assembly plugs into the analyzer is dry and that no foreign materials are present before installing the new edge connector 6 Place the new edge connector into the analyzer and push down on the assembly until the cover is flush with the instrument top 7 Reinsert the left and right guides by sliding each along the edge of the porch until they snap into the edge connector assem
87. erved at the 8 7 mg dL creatinine level Decreased creatinine results by approximately 25 at the 2 mg dL creatinine level Decreased creatinine results by approximately 70 at both the 0 9 and 8 7 mg dL creatinine levels Decreased creatinine results by 25 at both the 0 9 and 8 7 mg dL creatinine levels A 4 Lactate Substance concentration Acetaminophen 20 mg dL Acetaminophen 100 mg dL Cysteine 10 mg dL Glycolic Acid 10 mM Hydroxy Urea 500 umol L Sodium Bromide 200 mg dL Uric Acid 20 mg dL Expected Effect Increase lactate by 40 at lactate levels lt 18 mg dL Increase lactate by 25 at lactate levels lt 18 mg dL Decreased lactate levels by 30 Produces variable results at lactate levels lt 18 mg dL Decreased lactate results by approximately 30 at normal lactate levels lt 18 mg dL Decreased lactate results by approximately 20 at lactate levels lt 18 mg dL Decreased lactate results by 20 at lactate levels approximately 72 mg dL A 5 aioe PRECAUTIONS FOR BLOOD HANDLING Use generally accepted techniques for collecting and handling blood NCCLS Standard for the Percutaneous Collection of Arterial Blood for Laboratory Analysis 1992 and Protection of Laboratory Workers From Infectious Disease Transmitted by Blood Body Fluid and Tissue Second Edition Tentative Guideline 1991 e Both the cartridge and the collection device should be disposed of in
88. ext to the RJ45 serial port Intended Use The bar code reader can be used to scan the following information e Cartridge information Cartridge type lot code and cal code are all encoded in a single bar code found on the cartridge package label The cartridge package may be scanned with each test instead of manually selecting Product Type and verifying the information on the Verify Information screen e Glucose test strip information Lot code and Ctl code are encoded in separate bar codes found on the SureStepPro test strip bottle The bottle label may be scanned with each test instead of manually selecting Product Type and verifying the information on the Verify Information screen e User IDs User ID bar codes may be scanned replacing manual entry of IDs via the touchscreen keyboard e Patient IDs Patient ID bar codes may be scanned replacing manual entry of IDs via the touchscreen keyboard e QC Expected Values Expected values for Liquid Quality Control and Calibration Verification Control materials can be scanned from the expected values chart replacing the manual entry of values via the touchscreen keyboard During power up the IRMA TruPoint analyzer determines whether or not a bar code reader is connected to the analyzer and will display the appropriate screen prompts The bar code reader will only be activated on the entry screens for cartridge information User ID Patient ID and QC control settings Bar Code Scan Symb
89. f a sample type and site from pre defined list to be associated with a patient test record Screen Contrast Allows touchscreen backlight to be adjusted to one of nine settings for optimal viewing in all ambient light conditions Sleep Mode When the analyzer is on and has not been used for two minutes the analyzer goes into a 2 minute sleep mode screen goes dark to conserve battery power The user can return to the last screen displayed by touching the right side of the screen at anytime during sleep mode When powered by battery the analyzer powers down if the 2 minute sleep mode period passes without any activity When powered by AC adapter the analyzer will not shut down after 2 minutes of inactivity in sleep mode Entry of a User ID is required if the User ID feature is enabled to exit sleep mode During the two minute sleep mode the beeper if enabled will beep every 15 seconds unless the screen is on the main MENU or Enter ID screens e User ID Requires entry of a valid User ID prior to performing select functions e WVueLink Allows IRMA TruPoint patient test results to be transmitted to the Philips Agilent patient monitor for display BAR CODE READER Description A high performance linear imaging bar code reader is available for use with IRMA TruPoint analyzers that are equipped with an accessory port The bar code reader is connected to the round accessory port located on the back of the IRMA TruPoint analyzer n
90. gnostic tests are in progress Review Results I Once the EQC test is complete the analyzer displays the EQC Results status screen The initial result for an EQC test is either Passed or Failed 3 4 QC TEST OPTIONS Analyzing EE Edge Connector a Passed EQC Test Manual al Press view to view quantitative results EGC Test Results pH optional Press next from each screen to Pane une cane proceed through results for all analytes a L on a2 Press notes to select QC notes to attach to the QC record optional a3 Press print to obtain a printout Results may automatically print depending on auto print setup a4 Press done to return to the QC TEST OPTIONS menu Automatic a5 Results will print if the printer is configured to print and the analyzer will display the main menu or user BOC Results ID screen if required a6 If printer is not configured to print there will be no print out The main MENU will HE be displayed b Failed EQC Test Manual bl Press help for assistance in resolving the problem that caused the failure optional b2 Press notes to select QC notes to attach to the record optional b3 Press print to obtain a printout Results may automatically print depending on auto print setup b4 Press done to return to the QC TEST OPTIONS menu Automatic b5 If printer is configured to
91. he IRMA TruPoint barometer reading is not recommended Enter appropriate User IDs if the User ID feature is enabled e Establish quality control procedures and set up liquid controls control type lot level and limits SYSTEM FEATURES The IRMA TruPoint analyzer provides many optional software features that can be activated from the main MENU via the Settings Option The following is a summary of these features Please refer to Section 7 System Settings for additional detailed information Auto Print Enables automatic printing of results immediately upon completion of analysis or delayed auto printing after sample and or oxygen therapy information entry is complete If this feature is off a printout can still be obtained via the print key on the touchscreen Bar Code Reader A bar code reader is available for IRMA TruPoint analyzers equipped with an accessory port on the back of the analyzer Please refer to Section 1 Bar Code Reader for additional bar code reader information Beeper When enabled an audible beep alerts the user that an action is required or that a message is displayed Correlation Allows optional entry of slope and intercept values for each analyte to correlate IRMA TruPoint analyzer results to a reference method Correlation for Cardiopulmonary Bypass Pump Hematocrits Allows optional entry of hematocrit slope and intercept values specifically for samples from patients on cardiopulmonary bypass
92. hting the va en A amka desired result and pressing view cco 2a y ee Het Nat K ICa b1 print Prints a hard copy of the patient iagsserese7s i test results displayed b2 more Displays additional results and or a Mestis associated calculated values from same woos seimmng 37 ef test that do not appear on current we we it screen more ia Esam con b3 done Returns to Results Found picklist 4 If no results for the criteria entered are found the Unable to Recall No Results found for the dates entered or No Results found for the Patient ID entered screen displays Press edit to return to the Search Patient Results screen or ok to return to the PATIENT RESULTS menu 4 4 QUALITY CONTROL RESULTS From the RECALL menu press QC to access the QC TEST RESULTS menu This menu displays the following options Menu Returns to main MENU Recall Returns to RECALL menu last Displays results for the last QC test performed search Allows search of results by QC type Recalling Last QC Test Results QC TEST RESULTS m a 1 Press last from the QC TEST RESULTS menu Results display for the last QC test performed regardless of QC type The options available from the last results display are print Prints a hard copy of the QC test results displayed limits Displays QC limits if they have been established by the QA User notes Displays up to 3 QC notes that were
93. imitations and Safety Precautions This appendix describes limitations of the IRMA TruPoint system LIMITATIONS Measurements on the IRMA TruPoint analyzer are accurate and precise as shown in Appendix D Performance Characteristics However sources of error can arise from improper collection and handling of blood specimens pre analytical errors and certain physiological conditions COMMON SOURCES OF SAMPLING ERRORS The IRMA TruPoint system was designed to eliminate many pre analytical errors associated with testing delays and sample storage and processing Analysis errors can arise from improper collection or handling of blood specimens These errors can be related to phlebotomy technique heparin type and concentration speed of syringe fill inadequate sample mixing improper storage of sample and delays in analysis The NCCLS Manual is an excellent reference for sample collection and handling The following sources of sampling error should be considered anytime test results are inconsistent with the patient s condition or a previously established trend Pre Analytical Error e The sample was not analyzed promptly after collection Glycolysis by leukocytes platelets and reticulocytes may cause pCO and ionized calcium values to increase and pH pOs and glucose values to decrease e The sample was not collected anaerobically resulting in room air contamination pH pCO pO and ionized calcium values may change due
94. ing a test or upon recalling the last patient test result Highlight the correct patient bypass status and press next Bypass status must be selected for each test that includes hematocrit when this feature has been established by the QA Bypsee Btatna User If a patient bypass status was not selected onsyrass during the Calibrating phase the Bypass Status on oyee screen will display instead of the Analyzing l screen after sample injection A patient bypass status must be selected before results will display or print Select the patient bypass status and press next to advance to the Analyzing or Results screen PATIENT NOTES ENTERING PATIENT NOTES The Patient Notes feature allows pre defined Polen meee A 3 aa Process Err notes to be permanently associated with G Repestres OCs individual patient test records Up to 3 notes 5 reune O Pre Moal can be attached to an individual patient record 0 Post meat Te If the QA User enabled Patient Notes a notes button will be present on the Results screen Press the notes button to access the pre defined notes available for selection Use the up and down arrows to highlight the desired note and press the check box button Repeat for additional notes and press next when complete 2 19 QC LOCKOUT The QC Lockout feature allows the QA User to define the number of successful QC tests EQC and or liquid required to sup
95. it glucose creatinine Lactate Measurement Technology silver silver chloride electrode potentiometric measurement utilizing ion specific electrode ISE technology for the BUN urea sensor the NH4 generated from the reaction of urea with urease is detected amperometric measurement based on the principles of the Clark electrode 3 conductimetric measurement amperometric measurement the H202 generated from the reaction of glucose with glucose oxidase is detected amperometric measurement the H202 generated from the enzymatic reaction of sarcosine as produced by the enzymatic reaction of creatinine in the presence of creatinine amidohydrolase and creatine in the presence of creatine amidohydrolase in the presence of sarcosine oxidase is detected amperometric measurement the H207 generated from the reaction of lactate with lactate oxidase is detected C 1 Potentiometric measurements The IRMA TruPoint potentiometric sensors generate a voltage which is related to ion concentration according to the Nernst equation E E S log C1 C2 gt Eis the voltage generated gt E is a constant for the sensor gt S is the sensitivity of the sensor gt Cl and C2 are the ion activities outside and inside the sensor membrane The IRMA TruPoint system uses direct undiluted measurement methods Differences are known to exist between direct and indirect diluted methods due to the measure
96. ite The following published ranges should only serve as a guide 12 Table B 11 Measured pH pCO gt pOd Sodium Potassium Ionized Calcium Chloride BUN Urea Glucose Creatinine Hematocrit Lactate Reference Range 7 35 7 45 arterial 7 32 7 43 venous 35 48 mmH 4 7 6 4 kPa arterial 41 55 mmH 5 5 7 3 kPa venous 83 108 mmHg 11 1 14 4 kPa arterial 136 145 mmol L or mEq L 3 5 5 1 mmol L or mEq L 1 15 1 27 mmol L 2 30 2 54 mEq L 4 60 5 08 mg dL 98 107 mmol L or mEg L 5 23 mg dL 1 8 8 2 mmol L urea 30 60 mg dL 1 7 3 3 mmol L neonate 60 100 mg dL 3 3 5 6 mmol L child 74 106 mg dL 4 1 5 9 mmol L adult Concentration of glucose is higher in arterial than in venous samples 0 3 1 0 mg dl 27 88 mol l neonate 0 2 0 4 mg dl 18 35 umol I infant 0 3 0 7 mg dl 27 62 umol l child 0 5 1 0 mg dl 44 88 umol I adolescent 0 9 1 3 mg dl 80 115 umol l adult male 18 60 years 0 6 1 1 mg dl 53 97 mol l adult female 18 60 years 32 42 2 6 years 33 45 6 14 years l 39 51 adult male 35 47 adult female 0 5 1 6 mmol L 4 5 14 4 mg dL arterial 1 0 5 2 2 mmol L 4 5 19 8 mg dL venous 1 B 10 Calculated Reference Range HCO3 22 26 mmol L arterial 21 28 mmol L venous TCO gt 19 24 mmol L arterial 22 29 mmol L venous 3 BE 2 3 mmol L arterial or venous O gt Sat 9
97. l problems are those that cannot be detected by the analyzer s software e g the analyzer does not turn on or the printer does not operate Specific problems are those identified by the software e g low battery or faulty cartridge A screen message signals the presence of a specific operational problem or condition and guides the user through the resolution process 5 1 TROUBLESHOOTING GENERAL OPERATIONAL PROBLEMS Corrective actions are listed to help resolve each problem noted in this section If necessary call your service provider for service assistance PROBLEM CORRECTIVE ACTION S ANALYZER DOES NOT POWER ON when cartridge is inserted e Analyzer does not turn on 1 when right hand edge of screen is pressed 2 33 4 e Analyzer does not turn on 1 te Ea gs 22 Verify that the battery is installed or that AC adapter is plugged into a working outlet Try again pressing more firmly or longer on the screen Try a fully charged battery or AC adapter Verify that the battery is fully inserted into the analyzer Call your service provider Verify that a charged battery is installed or that AC adapter is plugged into a working outlet Remove and re insert the cartridge Verify that the cartridge is fully inserted into the analyzer Try inserting a new cartridge Install new edge connector if available Call your service provider BATTERY PROBLEMS ji e
98. layed 5 Press Liquid on the QC TEST OPTIONS HOE E i f menu a If no bar code reader is connected the GC TEST OPTIONS Select Product Type screen will display Go inom to step 6 m 8 je b If the bar code reader is connected the Scan cartridge bar code screen will display Scan the cartridge package label for the cartridge to be used The cartridge product type Lot Code and Cal Code are encoded in the single bar code on the cartridge label The IRMA TruPoint will automatically advance to the Insert Cartridge screen the Select Product Type screen will not be displayed Go to step 7 3 7 Select Product Type mame ca 6 Highlight the desired product type and press next The Insert Cartridge screen displays EHEH 43 I cr next Note e If only one product type was established in TEST SETTINGS Product Setup the Select Product Type screen will not display The analyzer will assume that the product is the same type as was established in TEST SETTINGS Product Setup See Section 7 Product Setup Open Cartridge Package 7 Check the expiration date on the cartridge package The analyzer will not allow testing with expired cartridges 8 Remove the cartridge from the package and retain the package until cartridge information is verified Note Cn EES i a E NEN O ATAN Verity Information TruPoint the Lot expired message will display and the test cannot proceed Rem
99. linical Chemistry 1986 vol 32 no 8 p 1448 National Committee for Clinical Laboratory Standards NCCLS Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture Document H3 A 3 1991 Riley JB Burgess BM Smith CA Crowley JC Soronen SW In vitro measurement of the accuracy of a new patient side blood gas pH hematocrit and electrolyte monitor J Extra Corpor Technol 19 3 322 329 1987 Maas et al Ion Selective Electrodes for Sodium and Potassium A New Problem of What is Measured and What Should be Reported Clinical Chemistry Vol 31 no 3 1985 p 482 Burtis CA Ashwood ER eds Tietz Fundamentals of Clinical Chemistry 5th ed 2001 A 7 This page intentionally blank A 8 Appendix B System Specifications and Cartridge Information This appendix includes IRMA TruPoint system specifications and IRMA TruPoint cartridge information SYSTEM SPECIFICATIONS General Specifications Table B 1 Category Operating Temperature Measurement Temperature Analyzer Shipping Storage Temperature Operating Relative Humidity Operating Barometric Pressure Sample Size Analysis time Size LxWxH and Weight Cartridge Temperature Card Analyzer Battery Charger Power Supply Rechargeable Battery Specification 12 30 C 54 86 F 37 C Blood gases 0 50 C 0 80 non condensing 350 900 mmHg measured by an onboard barometer 0 125 5 0
100. llary Collection Device instructions SAMPLE SIZE The minimum whole blood sample volumes that must be injected into a single use cartridge for a patient sample analysis are 200 uL if sample collected in a syringe 125 uL if sample collected in an IRMA TruPoint Capillary Collection Device Ensure that sufficient sample is collected to meet the minimum volumes required for injection into the cartridge GFNERAL SAMPLE COLLECTION GUIDELINES Time sample collection to minimize delays between collection and analysis Avoid drawing samples above an IV line to prevent dilution of the sample with IV fluid When drawing a sample from an indwelling line back flush and clear the line of IV fluids prior to sampling to remove anticoagulants or medications which might interfere with the test Allow the blood collection site to dry after being cleansed with alcohol to prevent hemolysis Fill the collection device to the appropriate capacity Incomplete filling may cause high heparin to blood ratios which may lower ionized calcium results and may affect other results Thoroughly mix samples collected in syringes BLOOD GAS SAMPLE HANDLING Expel any air present in the syringe immediately after collection and before the sample is mixed If a portion of the sample must be separated for other testing do not expose sample to air If a sample cannot be tested within 5 minutes of collection gt Expel all air from the syringe gt Cap or
101. lts will be transferred directly to a host system e g LIS HIS Press next to setup Automatic Results Device Transfer 7 25 Results Transfer e p off cancel next Results Transfer A off cancel idms host fe next Note e Selection of idms sets the IRMA TruPoint serial data transfer i e direct serial connection external modem or connection to a network server such as the Lantronix device baud rate to 19200 Configure idms for a 19200 baud rate Selection of host sets the IRMA TruPoint serial data transfer i e direct serial connection external modem or connection to a network server such as the Lantronix device baud rate to 9600 Configure the host for a 9600 baud rate The Results Transfer settings are ignored when Internal Modem or LAN 10 100 are selected as the communication method The Automatic Results Transfer option is not available when User Selects is configured as the Communications Method Automatic Results Transfer IRMA TruPoint analyzers that are powered by AC adapter may be configured to automatically transfer test results to idms or another connected system There are two Automatic Results Transfer settings Off The Automatic Results Transfer feature is disabled e On IRMA TruPoint results will automatically be transferred to idms or other connected system when certain conditi
102. lume heparin is recommended for ionized calcium testing sodium heparin may be used but sodium values may be elevated 1 2 mmol L Fresh capillary whole blood collected in the IRMA TruPoint Capillary Collection Device which contains balanced lithium heparin Fresh venous whole blood collected in a lithium heparin collection tube Balanced or low volume heparin is recommended for ionized calcium testing sodium heparin may be used but sodium values may be elevated 1 2 mmol L The sample should be transferred to a non heparinized 1 2 or 3 mL syringe for injection into a cartridge SYRINGE REQUIREMENTS Most standard ABG syringes are compatible with IRMA TruPoint cartridges The following general types of syringes should not be used with IRMA TruPoint cartridges Frictionless or pulsating syringes These syringes have plungers that will continue to travel downward after the user has stopped injecting This may result in a sensor error Syringes that contain a mixing ball or non dissolving disk impregnated with heparin The ball or disk may become lodged in the tip of the syringe and the sample may hemolyze when it is forced through or around the plug during injection Syringes that have a non standard Luer hub that does not fit the IRMA TruPoint cartridge Luer injection port 2 1 CAPILLARY REQUIREMENTS Capillary samples must be collected in the IRMA TruPoint Capillary Collection Device See Appendix F for detailed Capi
103. m a statistically valid number of samples When established the user has the option of selecting either On Bypass bypass correlation factors are used to calculate the hematocrit result or Off Bypass bypass correlation factors are not used in the hematocrit measure ment with each patient test Collecting bypass correlation data 1 Follow the instructions in steps 1 2 of Section 7 Collecting Correlation Data 2 Obtain at least 20 split sample hematocrit results from at least 5 patients on cardiopulmonary bypass USE ONLY SAMPLES COLLECTED FROM PATIENTS ON BYPASS PRE AND POST BYPASS SAMPLES SHOULD BE EXCLUDED Hematocrit samples collected from cardiopulmonary bypass typically yield results below 35 Therefore it is unlikely that samples collected to establish bypass correlation will span the entire clinical range 3 Follow the instructions in steps 4 7 of Section 7 Collecting Correlation Data Activating deactivating the bypass correlation setting 1 Highlight Bypass Correlation from TEST TEST SETTINGS SETTINGS and press edit Corraiaton a t 2 Highlight on or off button and press next aatan D Z If on selected go to Establishing or ui cs Changing Bypass Correlation Factors Establishing or changing bypass correlation factors 1 Ensure that Bypass Correlation is on see previous section Press next from Bypass Correlation screen 2 Enter slope value between 0 an
104. mL Approximately 60 to 300 seconds after sample injection depends on parameters 2 6 x 1 3 x 0 6 0 5 0 7 oz 66 x 33 x 15 24mm 15 21 g 11 5 x 9 5 x 5 5 lbs 4 oz 292 1 x 241 3 x 127mm 2381 7 5 x 3 5 x 3 5 2 Ibs 190 5 x 89 x 89mm 907g 6 25 x 2 25 x 1 25 14 oz 159 x 57 x 32mm 397g B 1 General Specifications continued Table B 1 Category Specification Display Liquid Crystal Display LCD touch screen Power Requirements Cartridges none Analyzer 7 2 V 2 amp by rechargeable battery or AC adapter Battery Charger Power Supply 100 240 Vac 1 Amp 50 60 Hz The battery charger is a Class ILED Product AC Adapter 100 240 Vac 1 0 Amps 50 60 Hz Empty Battery Recharge 2 5 7 hours NiMH Cycle Cli Analyzer and AC Adapter Classifications When used at the bedside either with battery or AC Adapter Equipment Classifications As Defined Per IEC60601 1 2003 TEC60601 1 2nd Edition e Protection Against Electrical Shock Class I Internally Powered Equipment with no applied parts e Protection Against Ingress of Liquids Ordinary no protection as defined by IEC 529 e Product Cleaning and Disinfection Only according to recommendations of the manufacturer s accompanying documentation e Mode of Operation Of Equipment Short time e Degree of Safety of Application in the Presence of Flammable Anesthetic Mixture With Air Oxygen or Nitrous Oxide Not S
105. may be low in patients on cardiopulmonary bypass potentially affecting the conductivity of the sample and therefore the hematocrit results When a patient comes off cardiopulmonary bypass they may still be hemodiluted Each facility should establish protocols to determine when a patient should be considered to no longer be hemodiluted The calculated total hemoglobin tHb is based on assumptions which may not apply to some physiological conditions 5 The calculated parameters for TCO HCO3 BEb BEecf tHb and O2Sat are based on assumptions which may not apply to some physiological conditions 2 The IRMA TruPoint system measures electrolyte ion activity and automatically adjusts electrolyte results to be consistent with results from indirect methods 8 This adjustment is valid only for an assumed activity coefficient and a typical concentration of plasma water 5 A 2 INTERFERENCES Interference studies were based on NCCLS EP7 P Serum or whole blood was spiked with potentially interfering substances The concentrations tested and the expected effects are shown below Chloride Substance concentration SCN 17 mmol L BUN Substance concentration SCN 17 mmol L Glucose Substance concentration Glutathione 1 mg dL Hydroxy Urea 500 umol L Todoacetate 900 mg dL Isoniazide 7 mg dL Pralidoxime Iodide PAM 16 mg dL Sodium Fluoride 1000 mg dL Thiopental 25 mg dL 13 mg dL
106. ment of ion activity rather than concentration1 Direct measurements read up to 7 higher than indirect methods for electrolytes because of the excluded volume occupied by plasma proteins and lipids The IRMA TruPoint system measures electrolyte ion activity and has been calibrated to agree with standard laboratory reference methods that are performed on plasma or serum Amperometric measurements The IRMA TruPoint amperometric sensors generate a current which is related to analyte concentration according to the relationship i S C B gt iis the current generated gt Cis the analyte concentration or partial pressure of the test sample gt Bis the current generated in the absence of the analyte Whole blood glucose measurements are approximately 12 to 15 lower than plasma concentrations gt The IRMA TruPoint system measures glucose concentrations in whole blood and has been calibrated to agree with standard laboratory reference methods that are performed on plasma or serum Conductimetric measurements The IRMA TruPoint analyzer determines hematocrit based on electrical conductivity which is related to hematocrit in whole blood hematocrit f 1 Q gt Q sample resistance gt conductivity 1 Q C 2 CALCULATED PARAMETERS Other parameters can be calculated by the IRMA TruPoint analyzer based on the measured values of a blood sample See Appendix B Table B 8 for the list of calculated pa
107. mmunications Date Format Date Time Auto Print Screen Contrast VueLink Appendixes A Limitations and Safety Precautions B System Specifications and Cartridge Information C Principles of Operation D Performance Characteristics E Default Settings F IRMA TruPoint Capillary Collection Device G Software Updates H Warranty Page 7 8 7 11 7 12 7 12 7 14 7 15 7 15 7 17 7 19 7 20 7 20 7 21 7 22 7 22 7 22 7 23 7 27 7 27 7 28 7 28 7 28 Al B 1 C 1 D 1 E 1 F 1 G 1 H 1 This page intentionally blank vi Section 1 The IRMA TruPoint Blood Analysis System INTRODUCTION This section outlines general information about the IRMA TruPoint Blood Analysis System and describes the installation process INTENDED USE The IRMA TruPoint Blood Analysis System is intended for use with IRMA TruPoint cartridges for the in vitro measurement of various critical care analytes in human whole blood See Appendix B Table B 6 for a list of the analytes that may be measured with the IRMA TruPoint system SYSTEM OVERVIEW The major components of the IRMA TruPoint system are a portable battery operated analyzer and disposable cartridges that contain sensors and a calibrant Cartridges come in a variety of analyte configurations Cartridges calibrate with every test using the self contained calibrant Instructions displayed on the interactive touchscreen guide the user through all steps of the te
108. nce Range Type im No Ranges Defined Pamma z xl h Continue for all appropriate analytes When complete press done i Repeat the steps 3c to 3g for the reference range types j When complete press done For Master and Type Specific defaults select Master on and Type Specific on Press next a To activate previously defined values press ok Reference Range Settings Oe Oe Q oema u b Please follow the above Master Default steps for 2b through 2f c Please follow the above Master Type Specific steps for 3b through 3j d When complete press done For no Reference Ranges select Master off and Type Specific off Press next and done 7 13 cJ O ue O Gu O mesin O Coe REPORTABLE RANGES The default reportable range for each analyte can be found in Appendix B Table B 8 Due to regulatory requirements some facilities may want to specify more narrow reportable ranges for certain analytes QA Users can establish a custom reportable range consisting of an upper and lower limit for each analyte Note Changing reportable ranges may affect stored records Stored results should be uploaded to idms before reportable ranges are changed An error message will appear upon entry of a reportable range that conflicts with established QC limits or reference ranges e g a QC or reference range limits cannot be outside a reportable range limit
109. nd Temperature Card to be free from defects in material and workmanship under normal use and service for a period of one 1 year after date of shipment warrants the Battery to be free from defects in material and workmanship under normal use and service for a period of ninety 90 days after date of shipment and warrants the IRMA TruPoint cartridges to be free from defect in material and workmanship under normal use until its stated expiration date subject to the following terms and conditions Claims of defects in material or workmanship must be reported to the Company and the product returned to the Company transportation prepaid within the warranty period If found by the Company s inspection to be defective in material or workmanship the IRMA TruPoint Analyzer Battery Charger Battery and Temperature Card will either be repaired or replaced at the Company s election free of charge and returned to the purchaser transportation prepaid If a cartridge is found to be defective it will be credited to the purchaser s account If inspection by the Company does not disclose any defect in material or workmanship the Company s regular repair or replacement charges will apply Improper use of or service to or the defacing or altering of the IRMA TruPoint Analyzer Battery Charger Battery Temperature Card or cartridge will void this warranty Limitation of Remedies The remedy of repair or replacement provided in this wri
110. ns that appear are based on search criteria selection a Search by Date al The First Date from the previous search or the current date automatically displays Accept displayed date or enter a new First Date oldest date for the search in the date format displayed at the top of the screen Press next a2 The Last Date from the previous search or the current date automatically displays Accept displayed date or enter anew Last Date newest date for the search in the date format displayed at the top of the screen Press next b Search by Patient ID Enter a Patient ID and press next Only results associated with that patient ID will display c Search by Date and Patient ID First Date MM DD YY 10 22 03 J ee ee ee ee Ce UC L Last Date MM DD YY 11 29 03 1 2 3 4 5 6 7 8 9 0 lt me Patient ID arma we 2 KJ ee Ce ee ee ee Enter both a date range and a Patient ID and press next Only results associated with that date range and patient ID will display 3 If there are results in memory for the search criteria entered the Results Found screen displays a picklist with test dates and times Use the up and down arrows to scroll through the list of results until the desired result is Results Found avjeesve ramo print all ane 12 40 4 amaj 10 23 02 12 33 v 40 92 09 ran L 123456789675 highlighted The analytes reported for that r
111. nsfer unsuccessful A send was pressed when Press the appropriate button there are no unsent records depending upon the transfer status of in the analyzer memory the results in the analyzer memory B resend was pressed when there are no previously sent records in the analyzer memory Data transfer between the 1 Verify that receiving system is analyzer and receiving ready e g DeviceCom is running system was unsuccessful 2 Verify that cables and adapters are properly connected to both the IRMA TruPoint and receiving system Use cables and adapters supplied by your service provider 3 Verify that transfer cable is connected to correct com port specified in DeviceCom setup 4 If transferring serially ensure that the IRMA TruPoint and receiving system baud rates match If the analyzer is configured to transfer to idms the receiving system must be set to a baud rate of 19200 If the analyzer is configured to transfer to host the receiving system must be set to a baud rate of 9600 5 If transferring by the LAN 10 100 make sure that the network settings are correct See Section 7 Communications 5 8 SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE MISCELLANEOUS Unable to Add Displays when adding a Press ok to return to the picklist of Maximum number have control via QC Settings and existing controls to allow deletion of been entered the maximum number of one or more
112. nt The default setting is 255 0 0 0 other common settings are 255 255 0 0 and 255 255 255 0 Enter the appropriate setting and press next b4 The Remote IP Address screen displays Enter the Remote IP Address using the format aaa bbb ccc ddd where aaa bbb cce and ddd are each a 1 to 3 digit value ranging from 0 to 255 Press next b5 The Remote Port screen displays This screen sets the IP Port of the remote idms computer The default setting is 3001 Enter the appropriate setting and press next Go to step 5 Gee H om J 299999 IDAD D J B Ca DOO OOo DIDIQQ 3001 D9999 IDDIDQYVO L There are two IRMA TruPoint test Results Transfer settings Off The IRMA TruPoint Results Transfer feature is disabled On IRMA TruPoint results may be transferred to idms or other connected system via serial port LAN 10 100 or modem All results transfers utilize the ASTM standard 1394 91 Standard Specification for Transferring Messages Between Clinical Laboratory Instruments and Computer Systems and ASTM standard 1381 91 Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems Highlight the on or off button and press next If on selected go to step 6 Highlight idms if IRMA TruPoint results will be transferred to idms or host if resu
113. nt cartridges are shipped in an insulated shipping container The shipping temperature range is 0 50 C Check the shipping temperature indicators that are enclosed with each shipping container Instructions accompany the indicators If the temperature indicators show that the shipping temperature range has been exceeded do not use the cartridges Call your service provider for replacement cartridges CARTRIDGE STORAGE AND EQUILIBRATION PROCEDURE Most cartridges are stored at room temperature Some cartridges however require refrigeration Refer to Appendix B Table B 7 for cartridge storage temperature information for all cartridge types Room Temperature Cartridge Storage and Equilibration Procedure IRMA TruPoint cartridges that require storage at room temperature 15 30 C 59 86 F must be removed from their shipping container and equilibrated to room temperature prior to use Equilibration times depend on the product type Refer to Appendix B Table B 7 for equilibration times Equilibrate cartridges as follows Remove cartridges from their shipping container upon receipt Place cartridges in the area where they will be stored The storage area must have a stable temperature between 15 30 C 59 86 F The cartridge storage temperature must not fluctuate more than 8 C 14 4 F If it does the cartridges must go through an additional equilibration period before they can be used Proper storage conditions should be docume
114. ntative maintenance procedures that can be performed on the IRMA TruPoint system by the operator including battery maintenance printer paper replacement barometer calibration general cleaning and edge connector cleaning and replacement The IRMA TruPoint system does not require preventative maintenance by service personnel and there are no user serviceable parts in the analyzer or its accessories Only authorized service personnel can service the analyzer Contact your service provider for servicing BATTERY MAINTENANCE The IRMA TruPoint system includes two rechargeable nickel metal hydride NiMH batteries one can be used to power the analyzer while the other is charging A battery takes approximately 5 5 10 hours to charge depending on the existing charge GENERAL INSTRUCTIONS For optimal battery performance follow these recommendations Use a battery until the battery icon meter bar is nearly empty When a battery is placed into a charger the charger first fully discharges then charges the battery The greater the charge remaining on a battery at the time of insertion into a charger the longer the charge cycle A fully charged battery takes 4 hours to discharge e Leave a battery in the charger until the green LED flashes continuously The green LED on the charger will blink continuously when the battery is at 100 capacity A battery should remain in the charger until the green LED blinks continuously See Se
115. nted daily by recording the minimum and maximum storage area temperatures Refrigerated Cartridge Storage Procedure The CR cartridges are stable through the expiration date indicated on the package label CR Cartridges must be removed prior to use from the refrigerator and sit at room temperature 15 30 C for a minimum of 15 minutes CR cartridges must be used within 8 hours of removal from the refrigerator CR Cartridges that are not used within 8 hours should be discarded Do not place unused cartridges back into the refrigerator 1 8 CARTRIDGE TEMPERATURE OPERATING RANGE The IRMA TruPoint temperature operating range is 12 30 C 54 86 F e Room temperature cartridges that are used in environments below the cartridge storage temperature range e g CVORs below 15 C 59 F must be used within 4 hours of transfer from the 15 30 C storage area to the colder area Cartridges that were not used within the 4 hour time limit must be returned to the 15 30 C storage area and go through an additional equilibration period before they can be used Refer to Appendix B Table B 7 for equilibration times e Refrigerated cartridges may be used until their out of refrigerator outdate INSERT CHARGED BATTERY OR AC ADAPTER INTO IRMA TRUPOINT ANALYZER e Insert a charged battery or AC Adapter into the IRMA TruPoint analyzer The insertion area is located on the left side below the carrying handle SYSTEM FEATURES AND SETUP
116. ntrol Performing a Manual EQC Test Automatic EQC Test Liquid Quality Control Liquid QC Material Requirements Performing a Liquid Control Test Initiate Liquid QC Test Temperature test Performing a Temperature Test References Data Access Overview Data Storage Recalling Results Patient Results Quality Control Results Results Transfer Manual Transfer of IRMA TruPoint Results Automatic Results Transfer 4 10 Section 5 Troubleshooting Overview Troubleshooting General Operational Problems Troubleshooting Specific Operating Problems Maintenance Overview Battery Maintenance General Instructions Removing the Battery Charging the Battery Routine Conditioning the Battery Analyzer Maintenance Changing the Printer Paper Calibrating the Barometer Cleaning System Components Cleaning the Touchscreen Cleaning the Battery Charger Power Supply and Analyzer Surfaces Cleaning the Battery Contacts Cleaning the Infrared Probe Cleaning the Edge Connector Cleaning the Temperature Card Replacing the Edge Connector System Settings Overview Setting Options Menu Test Settings Product Setup Lot Entry Calculations Test Information Section Correlation Bypass Correlation Display Units Reference Ranges Reportable Ranges Quality Control QC Settings QC Lockout Controls User ID Settings Default QA User ID Adding a New QA User ID User ID Options Device Settings Beeper Calibrate Barometer Co
117. of choice Press next Select Level 1 2 or 3 Press next a If the bar code scanner is attached to IRMA Please scan control bar codes A TruPoint the Please scan control screen will appear o ancol entry gt Scan the barcodes from the expected values sheet These sheets are available at www itcmed com Please scan control bar codes AB i Successfully Scanned gt The touchscreen will track bar code rane scan progress entry b If the barcode scanner is not being utilized proceed as follows Enter Control Lot 1 7 alpha numeric characters for the new control Press next Enter Expiration Date MM YY Press next Select Analytes to be reported for the new control by highlighting all desired analytes Press next Follow the series of Limits entry screens to establish control limits for each of the selected analytes The product type control level and control lot number appear on each screen Enter numeric lower and upper limits or press next through each screen to enter no limits 7 18 Editing an established control 1 2 3 4 Press QC on the SETTING OPTIONS menu Press Controls on the QC SETTINGS menu Highlight the product type of choice Press next The Controls screen displays a picklist of current controls Highlight the control to be edited and press limits The analyzer displays the current limits for the controttimits L1 Lot 1
118. of the cartridge inserted into the analyzer press back to return to the Select Product Type screen i EEL 12 The Verify Information screen displays the cartridge Lot and Cal Code from the most recent test performed on the same product type a If the Lot displayed matches the Lot of the cartridge inserted into the analyzer press next Proceed to step 13 b If the Lot displayed does not match the Lot of the cartridge inserted into the analyzer press edit to choose a different previously entered Lot or enter a new Lot for the first time b1 To choose a previously entered Lot Lot highlight the correct cartridge Lot now a e from the picklist Press next to return ae Y omn to the Verify Information screen If the ce j information is correct press next to continue patient test If the information is incorrect press edit to re enter the Lot and Cal Code 2 8 b2 To enter a new cartridge Lot for the let first time highlight new from the Tema picklist and press edit i JIG CH gt Enter the cartridge Lot using the Lot back alpha keypad Press next Deena WOWW PREERE woo gt Enter the Cal Code using the alpha Gal Code p keypad Press next to return to the asza r DBD ELE Verify Information screen If the WWD Wt information is correct press next to continue patient test If the information is incorrect press edit to re enter the Lot and Cal Code Not
119. ologies The bar code reader is factory programmed to read the following bar code symbologies Code 11 EAN JAN Plessey Code 39 Interleaved 2 of 5 Telepen Code 128 Matrix 2 of 5 UPC Codabar MSI Scanner Specifications Refer to the User s Guide that came with the bar code reader for detailed specifications and regulatory compliance statements Note e The Welch Allyn bar code reader uses a non laser red LED light source Connecting the Bar Code Reader 1 Ensure that the IRMA TruPoint analyzer is turned off 2 Connect the bar code reader cable to the round keyboard port on the back of the analyzer 3 The reader will be ready for use when the analyzer is powered back on Caution e The IRMA TruPoint analyzer can only determine the presence or absence of a bar code reader during analyzer power up Do not connect or disconnect the reader when the analyzer is on Doing so may result in damage to the reader or analyzer or the display of incorrect screen prompts Disconnecting the Bar Code Reader 1 Ensure that the IRMA TruPoint analyzer is turned off 2 Disconnect the bar code reader cable from the keyboard port on the back of the analyzer Mounting the Bar Code Reader The bar code reader may be attached to the IRMA TruPoint analyzer using the mounting clip that came with the reader Figure 1 6 1 Attach the clip to the IRMA TruPoint handle as shown Figure 1 6 Figure 1 7
120. on gel are present in the sample path after the initial sample injection remove them by injecting additional sample from the same syringe or by lightly tapping the top of the syringe plunger and then injecting additional sample from the same syringe e If air bubbles or calibration gel cannot be removed from the sample path press cancel to stop the test discard the cartridge and begin again with a new cartridge Proper injection technique will prevent air bubbles or calibration gel from being present in the sample path after initial sample injection 20 Ensure that no air bubbles or calibration gel are present in the sample path then immediately press test to continue sample analysis a The Analyzing screen displays if there is no sanie z required patient bypass status or patient ID 1 information to be entered ire er m 2 b If patient bypass status or patient ID eT information entry is required but not yet onsas entered the Bypass Status screen or ont bypass Patient ID screen will display when test is pressed The required information must be entered before results will display or print Refer to Patlat i0 Section 2 Entering Test Information and Ferio Section 2 Patient Bypass Status for details D29999 9 Enter the required information and press 6 7 8 9 0 lt Ga next to advance to the Analyzing or Results screen 21 When the test is complete remove the cartridge with the
121. on on 1 Connect Cable 3 the Device Update screen vi is ready receive Press button new done a receive all All profile settings will be sent to the analyzer overwriting the existing settings If new software or language updates are available they will be also be sent b receive new Only profile settings that have changed since the last analyzer update will be sent to the analyzer If new software or language updates are available they will be also be sent The available updates i e Languages Updates Available Software Settings None and the estimated Settings cao time it will take to complete the update will 12minutes display If there is a profile associated with gt the analyzer and there are no unsent records in the analyzer pressing ok will continue the update until completion If the update cannot proceed for one of the following reasons a message screen will be displayed a The analyzer is not associated with a profile gt Press ok to continue update Factory Warning No default IRMA TruPoint settings will Continuing with comet aa i update will reset overwrite existing analyzer settings If default settings new software or language updates are available they will be also be sent gt Press cancel to cancel update and return to the SETTING OPTIONS menu b Result Transfer setting is idms and Updates Available there are unsent
122. on the back of the IRMA TruPoint labeled Modem Connect the other end to an analog phone line 4 9 c IRMA TruPoint LAN 10 100 transfer Connect one end of a CAT5e patch cable to the LAN port on the back of the IRMA TruPoint labeled LAN 10 100 Connect the other end to a network port d External Modem transfer Connect one end of the RJ45 cable to the serial port on the back of the IRMA TruPoint labeled Computer Connect the other end to the external modem Some modems will require a RJ45 to DB25 connector and others will require a RJ45 to DB9 connector Note e External serial servers connect to the IRMA TruPoint 5 Verify that the receiving system is ready to receive IRMA TruPoint data and press one of the following buttons a send Sends all stored results that have not been previously transferred b resend Sends all results in memory that were previously sent along with a flag indicating their previous transfer status c cancel Returns to the recall OPTIONS menu or main MENU 6 Data transfer can be stopped while in progress by pressing stop the screen will return to the RECALL OPTIONS menu or main menu AUTOMATIC RESULTS TRANSFER IRMA TruPoint analyzers may be configured to automatically transfer test results to idms or another connected system IRMA TruPoint results will automatically be transferred to idms or other connected system when ALL of the following conditions are me
123. ons See Section 7 Communications for Results Transfer and Automatic Results Transfer Setup instructions MANUAL TRANSFER OF IRMA TRUPOINT RESULTS 1 Press send from either the main MENU or RECALL RECALL menu If a send button is not me A present the QA User has not turned Results we s Transfer on Status 2 Ifthe QA User selected either the Serial LAN 10 100 Internal Modem or External Modem transfer method option during Results Transfer setup go to step 4 3 Ifthe QA User selected the User Selects Communication Method transfer method option during Results soit eej Transfer setup the Communication Method Internal Modom screen displays Highlight the button next to tstemat modom nort the transfer method of choice and press next 4 The RESULTS TRANSFER screen displays RESULTS TRANSFER transfer instructions Connect the appropriate TE a Cl cable and adapter if required to the IRMA ney resend TruPoint analyzer and the receiving system a Serial Port transfer Connect one end of the RJ45 cable to the serial port on the back of the IRMA TruPoint labeled Computer Connect the other end to a receiving system serial port Note idms setup includes specifying which receiving system serial port will be used for data transfer Ensure that the cable is connected to the correct serial port b Internal Modem transfer Connect one end of the RJ11 cable to the modem port
124. ons These setting options include enabling or disabling the beeper and printer and setting the time date format and screen contrast Note e The Gluc Strip User privilege is available for users that have purchased the SureStep Pro Glucose Module an optional side attachment to the IRMA TruPoint analyzer Refer to the SureStep Pro Glucose Module User Manual for details The General User privilege allows both IRMA TruPoint cartridge and glucose strip testing if glucose module is present SYSTEM SETUP Prior to initial testing complete the following activities e Identify QA User s to supervise IRMA TruPoint setup and monitoring e Use the factory default QA User ID 123456 to access the USER ID SETTINGS menu New QA User ID s may be added and the default QA User ID deleted if desired e Review the factory default analyzer settings in Appendix E and make any necessary adjustments Refer to Section 7 System Settings for instructions on changing default settings e Perform an EQC test Section 3 Performing an EQC Test When the test is complete access the barometer setting and check the reading against the barometer in your facility If necessary change the barometric pressure value in the analyzer Section 7 Calibrate Barometer Note e The IRMA TruPoint barometer was calibrated at the factory and should read within 5 mmHg of a NIST calibrated barometer Use of a non NIST calibrated barometer to adjust t
125. ons are met see Section 4 Automatic Results Transfer for details Configure Automatic Results Transfer as follows 1 Highlight the on or off button and press Atorh tic Resulta next to setup the Automatic Results Transfer feature next Automatic Device Updates via DeviceSet DeviceSet is a PC software application that provides an easy and efficient way to create modify restore and manage configuration settings on all IRMA TruPoint analyzers at a site Settings profiles are established in DeviceSet and may be downloaded to IRMA TruPoint serially via modem or over a network A settings profile is a collection of IRMA TruPoint settings that includes most of the IRMA TruPoint settings that may be established manually via the IRMA TruPoint SETTING OPTIONS menu There are 2 Automatic Device Update settings Off The IRMA TruPoint Automatic Device Update feature is disabled e On IRMA TruPoint analyzers can automatically receive profile updates from DeviceSet and software and language updates when available 7 26 Automatic device updates occur after IRMA TruPoint results are transferred to idms or another connected system After results are sent the analyzer requests updates If updates are available the transfer will proceed automatically Following software upgrades DeviceSet automatically restores settings in the IRMA TruPoint which would otherwise revert to factory default settings Configur
126. ould be configured Required Refer to the appropriate Philips Agilent document for monitor operating instructions and other information related to the Philips Agilent patient monitoring system and VueLink Transmitting Results to VueLink 1 The patient test results displayed on the te Results Results screen are transmitted to VueLink E4 Pooh ao 1aahg 278 i when done is pressed only under the Het azine notes following conditions ca 1 nonM The VueLink option in DEVICE SETTINGS is on and The IRMA TruPoint analyzer is connected to a VueLink module residing in a patient monitor or monitor rack If there is no connection between IRMA TruPoint and VueLink pressing done will end the test and advance IRMA TruPoint to the appropriate screen The Sending to VueLink screen displays once bass a connection has been established The user has 15 seconds to verify that the patient ID from the test record transmitted matches the patient ID entered into the patient monitor Sending to VueLink a Patient ID verified within allotted time test results display on the patient monitor and the IRMA TruPoint advances to the appropriate screen depending on setup b Patient ID not verified within allotted time test results do not display on the patient monitor and the IRMA TruPoint advances to the appropriate screen depending on setup Transmission Errors If a connection is made
127. out of the sample path and into the waste area Note e Do not pull sample from the waste area back into the sample path Doing so may cause inaccurate results Bubbles or Calibrant in Sample Path Figure 2 3 A B C D A Cartridge before sample injection B Sample path properly filled after sample injection sample path is completely filled with no bubbles or calibrant present C Sample path improperly filled after sample injection sample path contains bubbles round and calibrant irregular Bubbles or calibrant may appear anywhere in the sample path D Sample path H4 properly filled after sample injection sample path is completely filled with no bubbles or calibrant present Note that it is normal for the enzyme pad to remain visible after sample injection If bubbles or calibrant do not move when additional sample is injected tap the top of the plunger to dislodge them then inject additional sample from the same syringe to push them into the waste area The entire contents of the syringe may be injected if necessary to either reach the minimum sample volume injection requirement 200uL or to displace bubbles or calibrant Do not inject more than 5 mL of blood into the cartridge If air bubbles or calibrant gel cannot be displaced from the sample path press cancel to stop the test discard the single use cartridge and begin again with a new cartridge 2 5 5 Once the sample path is comple
128. ove expired cartridge and initiate a new test with an in date cartridge If the wrong lot was selected on the Verify Information screen press ok to return to the Verify Information screen and press edit to enter or select the correct cartridge lot Remove Tape and Insert Cartridge into Analyzer Figure 3 1 9 Remove the protective tape if applicable from the cartridge leads Do not touch the cartridge leads after the tape has been removed Do NOT remove the luer cap from the cartridge Figure 3 1 10 Fully insert the cartridge into the analyzer within 15 minutes of opening the package Figure 3 2 Note Do not use a cartridge if it has been out of the package longer than 15 minutes Do not reuse a cartridge once it has been inserted into the analyzer 3 8 Verify Enter Cartridge Information 11 a If the cartridge package bar code was scanned go to step 13 b If manual entry ensure that the product Verify Information type Type displayed on the Verify Gmm cll Information screen is correct If the fata J Type t product type displayed does not match the type of the cartridge inserted into the analyzer press back to return to the Select Product Type screen 12 The Verify Information screen displays the cartridge lot number Lot and Cal Code from the most recent test performed on the same product type a If the lot number displayed matches the lot number
129. patient test recat al If no bar code reader connected the ome See ee Select Product Type screen displays Go to step 6 a2 If bar code reader connected the Scan cartridge bar code screen displays Scan the cartridge package label for the cartridge to be used The cartridge product type Lot Code and Cal Code are encoded in the single bar code on the cartridge label The IRMA TruPoint will automatically advance to the next screen the Select Product Type and Verify Information screens will not be 2 6 displayed Go to step 7 if cartridge not yet inserted or step 13 if cartridge has been inserted 5 b If the analyzer was powered on by cartridge insertion the Select Product Type or Scan cartridge bar code screen appears following insertion Note e If the QC Lockout option is on and lockout requirements have not been met a lockout message will display Refer to Section 2 QC Lockout for details Select Product Type 6 Highlight the desired product type and press A ames next The Insert Cartridge screen displays Ifa E _ _ j cartridge was already inserted to initiate the CED test go to step 11 s cr wont Note e If only one product type was established in TEST SETTINGS Product Setup the Product Type screen will not be displayed The analyzer will assume that the product is the same type as was established in TEST SETTINGS Product Setup See Section 7 Product Setup
130. perform analysis on one sample then is discarded Cartridge Calibration Prior to sample introduction the sensors on each IRMA TruPoint cartridge are automatically calibrated using a pre packaged calibrant The calibrant is manufactured and tested with NIST traceable gases and 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 following initial entry of a new cartridge lot or can be entered via the bar code reader 3 1 IRMA TRUPOINT QUALITY CONTROL The IRMA TruPoint Quality Control program consists of the following four elements 1 Comprehensive automatic on line quality and procedural checks that continuously monitor sensor response and instrument response The IRMA TruPoint software monitors responses throughout both the calibration and sample analysis phases of a test If an uncharacteristic response is detected during the calibration phase the system rejects the cartridge and does not allow that cartridge to be used for sample analysis Since sample introduction occurs after calibration rejected cartridges do not result in the loss of the sample If an uncharacteristic sensor response is detected during the sample analysis phase the system suppresses that sensor and does not report an analyte result for
131. port patient testing When activated either 1 2 or 3 successful quality control tests must be run during a shift or the analyzer will deny access to the patient test screen or in the case of a partial lockout condition limit access to the tests available Shifts can be specified as 8 12 or 24 hours in length SATISFYING QC LOCKOUT GENERAL RULES QC Lockout can be configured separately for EQC and for each product type liquid e When EQC Lockout is on an EQC test failure at any time i e even if EQC passed earlier on a shift will lockout patient testing Following an EQC test failure a passed EQC test is required to resume patient testing e When liquid QC limits have been established results must fall within the established QC limits to be considered a successful test and satisfy QC lockout requirements e When no liquid QC limits have been established running the designated number of controls will satisfy QC lockout requirements for all non suppressed results e Result Suppression during an liquid QC test If an individual sensor on a cartridge errors during the analysis phase of an liquid QC test the result for that sensor and any other sensors that are dependent on that sensor will be suppressed Suppressed results will be dashed out on both the screen and printout and will not satisfy QC lockout requirements for the associated analyte group with or without QC limits established e Ifa patient test is initiated
132. pressing the Recall button on the main MENU The following options are presented Patient Search for patient test records by patient ID and or date range or recall results for the last test performed Results and associated test information can be viewed and or printed Test information can be modified when recalled by the last result performed option if the record has not been sent to idms VueLink or an LIS HIS Qc Search for QC test records by QC type product type control lotlevel and or date range or recall results for the last QC test performed QC Notes can be modified when recalled by the last result performed option cc Send When the results transfer option is on new or previously transferred results can be sent via the RS232 port LAN 10 100 or modem to another system capable of accepting the ASTM output i e idms or other information systems capable of accepting ASTM formatted data Status View the battery information and About IRMA TruPoint screens This information may be requested by your service provider to help resolve operating problems 4 1 Logs The error usage and transfer logs can be printed This information may be requested by your service provider to help resolve operating problems RECALLING RESULTS PATIENT RESULTS From the RECALL menu press Patient to access PATIENT RESULTS the PATIENT RESULTS menu This menu displays the following options uu Menu Retu
133. r sample volume 1 Firmly attach the syringe to the cartridge luer injection port If the syringe does not have a luer lock tip place the syringe tip in the injection port and give the syringe a slight twist to firmly seat it in the port 2 Place your fingers around the syringe so Figure 2 1 that your thumb rests on top of the plunger Figure 2 1 Inject the sample by depressing the syringe plunger in a single quick controlled motion similar to the motion used to press a stopwatch button This initial injection should be done forcefully enough to eject the calibrant from the sample path Figure 2 2 3 Stop injecting when you feel the sample eject the calibrant from the sample path If you can see the sample pushing the calibrant out of the sample path you are injecting too slowly sample path ote e Do not inject the entire syringe contents i e do not push the syringe plunger all the way down until it bottoms out during the initial sample injection Doing so may hemolyze the sample 4 Following initial sample injection confirm that the sample path is completely filled with sample and that no bubbles or calibrant are 2 4 present Figure 2 3 Bubbles or calibrant should rarely be seen if proper injection technique is being used The sample path was designed to be easily viewed If bubbles or calibrant are present in the sample path slowly inject additional sample to push them
134. rameters reported by the IRMA TruPoint system The following equations are used to calculate each of the parameters Bicarbonate 311 Two formulas are available for the calculation of bicarbonate Severinghaus NCCLS or Siggaard Andersen Refer to Section 7 Calculations for instruc tions on formula selection equation HCO3 0 0307 x pCO x 10 PH 6 1 Siggaard Andersen formula HCO3 0 230 x pCO x antilg pH pKp gt pKp 6 125 lg 1 antilg pH 8 7 Severinghaus NCCLS formula is based on the Henderson Hasselbach Total Carbon Dioxide 3 11 Total carbon dioxide TCOy is the sum of bicarbonate and dissolved CO gt TCO H2CO3 HCO3 Severinghaus NCCLS Bicarbonate formula H2CO3 0 0307 x pCO or TCO 0 0307 x pCO2 HCO3 Siggaard Andersen Bicarbonate formula H2COs3 0 230 x pCO or TCO 0 230 x pCO HCO3 C 3 Base Excess of Blood 412 Base excess of blood BEb also called in vitro or actual base excess is the difference in concentration of strong base in whole blood and in the same blood titrated with strong acid or base to pH 7 40 pCO2 5 33kPa at 37 C Two formulas are available for the calculation of base excess Severinghaus NCCLS or Siggaard Andersen Refer to Section 7 Calculations for instruc tions on formula selection Severinghaus NCCLS formula BEb 1 0 014 x Hb HCO3 24 8 1 43 x Hb 7 7 pH 7 4 gt Hb is the hemoglobin value entered
135. rials are not available contact your service provider to order a replacement BRING THE ANALYZER TO ROOM TEMPERATURE The IRMA TruPoint temperature operating range is 12 30 C 54 86 F If the analyzer is exposed to a temperature outside of that range for a significant period of time an instrument temperature error message may display The analyzer must equilibrate at a temperature within the temperature operating range for a minimum of 30 minutes before testing may resume ASSEMBLE THE CHARGER Connect the power supply to the IRMA TruPoint charger Connect the wall cord to the power supply Plug the wall cord into an electrical wall outlet 110 VAC 60Hz or 220 VAC 50 Hz CHARGE THE BATTERY Conditioning Charge Prior to initial use condition each battery as follows Insert a battery into the battery charger The battery should click into the charger when properly inserted The yellow light indicates that the battery is charging Charge the battery for 24 hours After 24 hours remove the battery from the charger then reinsert the battery into the charger Leave the battery in the charger until the green light flashes continuously indicating that the battery is fully charged The battery should remain in the charger until it is needed for use in the analyzer Routine Charge See Section 6 Charging the Battery Routine for routine battery charging instructions UNPACK THE IRMA TRUPOINT CARTRIDGES IRMA TruPoi
136. rns to main MENU Recall Returns to RECALL menu last Displays results for the last patient test performed search Allows search of results by date and or patient ID Recalling Last Patient Test Results 1 Press last from the PATIENT RESULTS Results menu Results display for the last patient test 09 10 06 17 08 performed regardless of product type The 164927807 options available are Presents the Test Information O2 p Resales IEJ Therapy Bypass Status screens that were Bor ao Imang 372 enabled at the time of the patient test ED Bet aaa Qaes J This information may be added or edited more fee aaa cone on Zast result recall if the record has not been sent to idms HIS LIS or another connected system print Prints a hard copy of the patient test results displayed more Displays additional results and or associated calculated values from the same test that do not appear on the current screen notes Displays up to 3 patient notes that were added following the test Notes may be added or edited on last result recall done Returns to the PATIENT RESULTS menu Recalling Patient Test results by S earch SEARCH PATIENT RESULTS 1 Press search from the PATIENT RESULTS Ceanes menu The Search Patient Results screen mme presents the By Date and By Patient ID search G arrumo G Con options Select desired search criteria and press next 4 2 2 Scree
137. rom the refrigerator and sit at room temperature before they can be used Table B 7 B 6 REPORTABLE RANGES The default reportable ranges for each parameter are shown in Table B 8 Table B 8 Measured pH pCOz pO Hct Nat Kt iCa Cl BUN urea BUN Urea Glu Creatinine Lactate Calculated HCO37 TCO Beb Beecf O gt Sat tHb iCa N 6 000 8 000 pH units 4 0 200 0 mmHg 0 53 26 66 kPa 20 0 700 0 mmHg 2 67 93 33 kPa 10 0 80 0 100 800 SI 80 0 200 0 mM mEq L 1 00 20 00 mM mEq L 0 20 5 00 mM 0 80 20 04 mg dL 0 40 10 00 mEq L 30 0 150 0 mM mEq L 3 150 mg dL 1 1 53 5 mM 6 321 mg dL 1 1 53 4 mM 20 500 mg dL 1 1 27 8 mM 0 2 12 mg dL 18 1061 mol L 0 30 12 mmol L 2 7 108 mg dL 0 99 9 mM 0 99 9 mM 99 9 mM 99 9 mM 0 100 3 4 27 2 g dL 2 1 16 9 mM 0 20 5 00 mM 0 80 20 04 mg dL 0 40 10 00 mEq L Note mM is the IRMA TruPoint display abbreviation for mmol L B 7 DISPLAY RESOLUTION The display resolution for each parameter is as follows Table B 9 Measured Calculated pH 0 001 pH units IHCO3 0 1 mM pCO 0 1 mmHg 0 01 kPa TCO 0 1 mM pO 0 1 mmHg 0 01 kPa Beb 0 1 mM Hct 0 1 001 SI Beecf 0 1 mM Nat 0 1 mM mEq L O2Sat 0 1 Kt 0 01 mM mEq L tHb 0 1 mM g dL iCa 0 01 mM mEq L mg dL iCa N 0 1 mM cr 0 1 mM mEq L mEq L mg dL BUN urea 1 mg
138. rs Depress the Cal Cap firmly and quickly to dispense the calibrant and press next The calibrant must be dispensed within 1 minute or the test is terminated and an Error message appears Select Control Type Lot and Level to be Tested 14 Scroll through the list of established controls Select Control using the arrow keys until the desired control Lovet 1 53023 I for the test is highlighted Press next to select Levei s3040 Y the highlighted control The Calibrating pel oot screen appears indicating that calibration is in progress Calmeatiog Le ire Note e IRMA TruPoint generates an error if the calibration code is not verified or the control is not selected within approximately 2 minutes of cartridge insertion Prepare Control Sample 15 Shake the control sample to equilibrate the gas and liquid contents according to the manufacturer s recommendations To ensure sample integrity avoid warming the ampule in the palms of your hands and do not open the ampule until calibration is complete Remove Luer Cal Cap Inject Control Sea coal Sample and press test tat and eat 16 The Calibration Complete screen displays 3 Prese teat when calibration is complete Twist and lift gm g the luer or Cal cap to remove it from the injection port The sample must be injected within 4 minutes of completing calibration A timer displayed at the bottom of the screen counts down from 4 min
139. rtridges require liquid blood gas control linearity and proficiency testing material Do not use perfluorocarbon based materials The IRMA TruPoint cartridges require controls that contain physiologic concentrations of electrolytes i e controls that have assayed values for electrolytes on the control package insert even if electrolyte results will not be reported The IRMA TruPoint system requires hematocrit controls that are intended for use with conductive hematocrit methodologies 3 6 PERFORMING A LIQUID CONTROL TEST Turn IRMA TruPoint Analyzer On 1 Touch the right hand edge of the screen to turn the analyzer on Do NOT insert a cartridge to power on the analyzer Note e All QC tests must be initiated via the main MENU QC Test option If a cartridge is inserted to power on the analyzer or inserted at the main MENU screen the analyzer will automatically initiate a patient test not a QC test Enter User ID optional 2 If the User ID option has not been activated go to step 4 3 Ifthe User ID option is activated the Enter or Scan ID screen will display The User ID may be entered using either the alpha numeric keypads or the bar code scanner a Entry via touchscreen keypads enter your User ID and press next b Entry via bar code scanner scan your User ID The screen will automatically advance Initiate Liquid QC Test 4 Press QC Test on the main MENU The QC a TEST OPTIONS menu is disp
140. rvers connect to the IRMA TruPoint serial port Internal Modem The internal modem default setting is disabled The modem must be enabled prior to establishing modem results transfer settings Enable the internal modem as follows Turn the IRMA TruPoint analyzer off Touch the right side of the touchscreen while simultaneously holding down the lower left corner of the touchscreen to access the Enter Feature Code screen system External Modem An external modem may be used with the IRMA TruPoint analyzer Internal LAN 10 100 device A LAN 10 100 port is located on the backside of IRMA TruPoint analyzers equipped with an internal LAN 10 100 device A CAT Se patch cable is used to connect the IRMA TruPoint to the receiving system 7 23 Setting up communications 1 Highlight Communications in the DEVICE SETTINGS picklist Press edit 2 Select a data Communications Method If 79 Commaunleattons Method more than one method will be used select the Serial Setects C e User Selects option which allows selection ofa Jea communications method each time data A rert transfer is initiated If only one method is selected that method will automatically be used whenever data transfer is initiated Press next a If Serial is highlighted go to step 5 b If Internal Modem or External Modem is highlighted or User Selects is highlighted on an analyzer that has Internal or External Modem as
141. s Mean mg dL SD CV Day 4 Number of samples Mean mg dL SD CV Day 5 Number of samples Mean mg dL SD CV Level 1 11 48 2 3 54 73 12 48 6 2 17 45 12 47 6 2 54 5 3 12 47 2 2 97 6 3 12 46 7 3 01 6 4 Level 2 12 102 7 6 16 6 0 11 105 9 3 01 2 8 12 103 7 2 75 2 7 11 101 9 3 22 3 1 12 101 0 5 80 5 7 D 7 Level 3 12 200 7 6 90 3 4 12 203 3 7 53 3 7 12 194 5 7 68 3 9 12 196 2 7 81 40 12 198 1 7 00 3 5 Level 4 12 353 4 18 96 5 4 12 351 7 9 19 2 6 12 351 2 19 75 5 8 11 349 9 20 14 5 8 12 350 5 16 77 4 8 PRECISION CONTINUED Cr Level 1 Level 2 Day 1 Number of samples 12 11 Mean mg dl 1 5 8 2 SD 0 09 0 46 CV 6 1 5 6 LA Level 1 Level 2 Level 3 Mean mmol L 0 7 2 5 6 7 SD 0 056 0 085 0 331 CV 7 1 3 4 4 9 D 8 Appendix E Default Settings This section describes factory default settings for the IRMA TruPoint blood analysis system DEFAULT SETTINGS TABLE E 1 Refer to Section 7 System Settings for instructions on establishing IRMA TruPoint system settings The factory default system settings are as follows Category User ID Settings e QA User ID e User ID e User ID on printout Device Settings e Beeper e Communications e LAN 10 100 if applicable e Date Format e Date Time e Auto Print Results e Screen Contrast Defaul
142. s activated the Enter or Scan ID screen will display The User ID may be entered using either the alpha numeric keypads or the bar code scanner a Entry via touchscreen keypads enter your User ID and press next b Entry via bar code scanner scan your User ID The IRMA TruPoint will automatically advance to the next screen Initiate Temperature test 4 Press QC Test on the main MENU The QC TEST OPTIONS menu is displayed 5 Press the Thermometer on the QC TEST OPTIONS menu to initiate a temperature test Insert Temperature Card TEMPERATURE TEST 6 Fully insert the Temperature Card into the ee ee Coch analyzer Verify Card Information Verity information 7 Verify that the Temperature Card Serial we Cc Number and Cal Code match the information fs displayed on the Verify Information screen wt 3 13 a If the information displayed matches the information on the Temperature Card press next Proceed to step 8 b If the information displayed does not match the information on the Temperature Card press edit to enter or select the correct serial number and Cal Code Verify the information and press next 8 The Analyzing screen appears indicating that the temperature test is in progress Review Results 9 Once the temperature test is complete the analyzer displays the Temperature Test Results status screen The result for a temperature test is either Passed or Failed
143. s away from metal objects CLEANING THE INFRARED PROBE Figure 6 5 Examine the infrared IR probe surface daily for dirt or contamination Clean the probe surface using a swab moistened with isopropyl alcohol or a 10 bleach solution Figure 6 5 The square glass surface of the probe should appear shiny and reflective when clean Allow the IR probe to completely dry before testing 6 6 CLEANING THE EDGE CONNECTOR Clean the edge connector only if it is accidentally contaminated with blood or other contaminants or when EQC Temp Test or sensor error codes indicate possible contamination Use the ITC Edge Connector Cleaning Kit PN 450000 as follows 1 Remove battery or AC adapter from IRMA TruPoint Analyzer 2 Open and completely unfold WET pad Place pad in front of the edge connector 3 Use Edge Connector Cleaning Strip to push pad into edge connector 4 Pull pad out of edge connector 5 Repeat cleaning moving pad left and right in edge connector Pull pad out of edge connector 6 Open and completely unfold DRY pad Place pad in front of the edge connector and repeat steps 3 through 5 Note e Do not clean the edge connector on a routine basis e Do not clean the edge connector with anything other than the ITC Edge Connector Cleaning Kit unless instructed to do so by your service provider CLEANING THE TEMPERATURE CARD Inspect the Temp Card leads for dirt or contamination prior to ins
144. side of the acceptable allow analyzer to equilibrate at a temperature operating range temperature within the temperature 12 30 C 54 86 F operating range for at least 30 minutes before resuming testing ANALYZER PROBLEMS Instrument Error Error Self test failed during Press quit to power off analyzer Code XXXX Press quit power on or the analyzer power analyzer back on and restart experienced a recoverable Instrument Error Error Code XXXX Press quit and call technical support Instrument Error Record These Values Call Technical Support Attention No functional printer system failure Analyzer experienced an unrecoverable system failure Analyzer experienced an unrecoverable system failure Printer is not operational Press quit to power off analyzer Call your service provider for assistance Record values displayed and press quit to power off analyzer Call your service provider for assistance Press ok to acknowledge the message Call your service provider for assistance Loading Paper Displayed anytime that the Replace the printer door cover to printer door is removed return to previous screen ANALYZER POWER PROBLEMS Low Battery Low battery condition was Press quit to power off analyzer reached that will not allow replace the battery with a freshly continued analyzer charged battery operation WARNING Remove AC adapter voltage w
145. splays a product type picklist pa O cai j Highlight the desired product type and press m ca edit Press on to activate or off to deactivate CC Lockout QC Lockout for the selected product type and Cea press next The Analyte Lockout screen eH displays when on is selected next 7 16 gee up or modifying QC lockout schedule The Analyte Lockout screen displays the PH pCO2 p02 QC LOCKOUT current settings for the first analyte analyte 9a group available on the product type selected A 3 oe CH Press on to activate or off to deactivate pea 1 testis Ca QC Lockout for the selected analyte analyte group If on selected a Press next to keep current settings and advance to the QC lockout settings screen for the next analyte available on the product type b Press edit to change settings 5 Select shift length 8 12 or 24 hours from the smmremm Shift Length screen Press next Deg s pas 6 Select Shift 1 Start time using the numeric and eS 5 colon keys Press next pr O 7 The screens that follow will depend upon ae whether EQC or Liquid QC Lockout is being 07 00 amp vee configured OOOO 00 999999 a EQC Lockout Select Shifts for Lockout Shifts for BQC Lockout 1 2 or 3 by highlighting the yes button D Cs next to desired shifts Press next to return to bD c the Sele
146. stem is manufactured under one or more of the following patents 5 232 667 D351 910 and 6 066 243 IRMA TruPoint cartridges are manufactured under one or more of the following patents 5 223 433 5 325 853 5 384 031 5 781 024 D351 913 5 968 329 Other patents pending B 5 CARTRIDGE ANALYTE CONFIGURATIONS IRMA TruPoint cartridges are available in the following analyte con figurations Table B 6 Cartridge Measured Calculated BG pH pCO pO HCO37 TCO gt BEb BEecf OpSat cc pH pCO pO Hct HCO37 TCO gt BEb BEecf Nat Kt iCa O gt Sat tHb iCa N H3 Het Nat KF iCa tHb H4 Hct Nat KF cr tHb BUN urea GL Glu Nat K clr CR Creatinine MDRD GFR LA Lactate CARTRIDGE EQUILIBRATION TIMES Following removal from their shipping container IRMA TruPoint cartridges must equilibrate to their storage environment prior to use see Section 1 Cartridge Storage and Equilibration Procedure Equilibration times depend on the product type as follows Table B 7 Cartridge Equilibration Storage Temperature Warm up Time Time Hours Minutes BG 72 15 30 C 59 86 F None CC 72 15 30 C 59 86 F None H3 1 15 30 C 59 86 F None H4 1 15 30 C 59 86 F None GL 1 15 30 C 59 86 F None CR None 2 8 C 35 6 46 4 F 15 LA 1 15 30 C 59 86 F None Refrigerated cartridges must be removed f
147. sting process Patient and sample information can be entered during analysis Test results are displayed within approximately 90 seconds after sample injection Test results and associated information can be automatically printed via the on board printer Test results and associated information can be transmitted via serial LAN10 100 or modem port to the Integrated Data Management System idms or other connected system capable of accepting ASTM output CLIA COMPLEXITY CLASSIFICATION The IRMA TruPoint Blood Analysis System has a moderate complexity CLIA classification The optional SureStep Pro Glucose Module has a waived status CLIA classification see SureStep Pro Glucose Module User Manual IMPLEMENTATION An implementation protocol is available from your service provider upon request SYSTEM COMPONENTS SYSTEM MAJOR COMPONENTS Figure 1 1 A IRMA TruPoint analyzer B Battery charger PN 442900 and power supply PN 573400 C Two rechargeable batteries PN 448700 D Temperature card E User manual F Two rolls of thermal printer paper PN 403800 G AC Adapter PN 440100 Not Pictured IRMA TruPoint cartridges not pictured are ordered packaged and shipped under separate cover Additional system components are available for use with the IRMA TruPoint system including the Integrated Data Management System idms the SureStepPro Glucose Module PN 444100 an AC power adapter PN
148. t 1 The IRMA TruPoint Communications Method is configured to one of the following serial internal modem LAN 10 100 or external modem Automatic Results Transfer will not work when the Communications Method is configured to User Selects 4 10 The Automatic Results Transfer option is A D Tiri configured on The IRMA TruPoint analyzer is operated with ire the AC adapter Automatic Results Transfer will not initiate when the analyzer is powered by battery The IRMA TruPoint analyzer is connected to the receiving system via the appropriate cable After a four to six minute period of inactivity on the analyzer the IRMA TruPoint will make a single attempt to transmit results If all of the above criteria have been met the IRMA TruPoint will begin to transfer results and the Results Transfer in Progress screen will display Data transfer can be stopped while in progress by pressing stop the screen will return to the main MENU or Enter ID screen Note See the idms User Manual for idms setup instructions and cable and adapter information See the DeviceCom User Manual for DeviceCom setup instructions See the External Modem User Manual for setup instructions 4 11 This page intentionally blank 4 12 Section 5 Troubleshooting OVERVIEW The IRMA TruPoint Blood Analysis System troubleshooting information is organized to address both general and specific operating problems Genera
149. t Product Type screen during a patient test Product types that are locked out will have the padlock icon over their selection button and may not be selected until QC lockout requirements have been met Sk Pressing this key erases the last character in the display Patient Temperature Icon displays with patient temperature in both F and C in upper right corner of a blood gas test results screen Battery Icon displays in the upper right corner of all screens except the patient test and QC test screens A dark meter bar in the battery icon represents the battery capacity See Section 6 Battery Maintenance for details i 1 Alpha numeric keyboard entry Allows entry of information from an alpha numeric keypad that automatically appears when a keypad entry is required SYSTEM SECURITY The IRMA TruPoint analyzer offers 3 user security levels QA User s have access to all IRMA TruPoint test recall and setting options QA Users have sole access to barometer calibration communications configuration results transfer VueLink and setup of QC Lockout User ID and QC General Users have access to all IRMA TruPoint test and recall options and limited setting options These setting options include enabling or disabling the beeper and printer and setting the time date format and screen contrast Gluc Strip Users may perform and recall only glucose strip EQC and temperature tests and have limited access to setting opti
150. t Setting 123456 Off Off On Communications Method Serial Results Transfer Off Results Transfer Destination idms Automatic Results Transfer Off Automatic Device Update Off IP Address 0 0 0 0 Gateway Off Gateway IP Address 0 0 0 0 Subnet Mask 255 0 0 0 Remote IP Address 0 0 0 0 Remote Port 3001 MM DD YY Current U S CST 24 Hour Clock Immediate Middle Setting 5 E 1 Category Test Settings e Product and Parameter Setup e Calculations e Patient tHb for BEb Calc e BE HCO3 Calculation e pO Temperature Formula e Correlation Bypass Correlation e Display Units e Reference Ranges e Reportable Ranges Test Settings Test Information e Oxygen Therapy e Patient ID e Patient Temperature e Sample Type Sample Site e Patient Notes e QC Notes QC Settings e QC Lockout Default Setting All products and parameters enabled On HCO3 TCO BEb BEecf OSat tHb and MDRD GFR Off iCa N 15 g dL Default Severinghaus NCCLS Severinghaus Off See Appendix B Table B 8 Off Default Off Optional 0 20 characters On Off Off Off Off E 2 Appendix F IRMA TruPoint Capillary Collection Device INTENDED USE The IRMA TruPoint Capillary Collection Device is intended for blood collection and the transfer of whole blood samples into IRMA TruPoint cartridges DESCRIPTION Each capillary collection device contains 70 IU mL balanced heparin and has a fill vol
151. t will automatically print upon completion of sample analysis Delayed Test results automatically print when the done button is pressed from the Results screen 1 Highlight the desired print format Press next SAP AktG print EEC veyed C CE SCREEN CONTRAST Screen contrast can be set to different levels for optimal viewing in different ambient light conditions The first level provides the least contrast between the background and characters the last level provides the greatest contrast between the background and characters Screen contrast changes immediately upon pressing the selected contrast setting 1 Use the left lt and right gt arrows to select gt Sereen Contrast the optimal contrast setting Press next VUELINK VueLink is an optional module for the Philips Agilent monitoring system that allows IRMA TruPoint patient test results to be displayed on the Philips Agilent bedside monitor There are two IRMA TruPoint VueLink settings e Off The IRMA TruPoint VueLink option is disabled IRMA TruPoint cannot send test results to the patient bedside monitor even if it is physically connected to a VueLink module e On IRMA TruPoint results can be transferred to the patient bedside monitoring system when connected to a VueLink module via the IRMA TruPoint serial port 1 Highlight the desired VueLink setting Press VueLink next i cancet 7 28 Appendix A L
152. tely filled with a minimum of 200 uL of sample press test to begin sample analysis Leave the syringe attached to the cartridge until the analysis is complete INJECTING A CAPILLARY SAMPLE The IRMA TruPoint Capillary Collection Device must be used to collect and inject samples into IRMA TruPoint cartridges Refer to Appendix F of this manual or the IRMA TruPoint Capillary Collection Device package insert for instructions PATIENT TEST PROCEDURE PERFORMING A PATIENT TEST Initiate a Patient Test There are two ways to begin a patient test 1 Touch the right hand edge of the screen to turn the analyzer on or 2 With the analyzer off insert a cartridge to turn the analyzer on and automatically initiate a patient test see steps 7 10 for cartridge insertion instructions Enter User ID optional 3 If the User ID option has not been activated go to step 5 4 If the User ID option is activated the Enter or f ee Sete Scan ID screen will display The User ID may a m oma be entered using either the alpha numeric DADAAAQD keypads or the bar code scanner 5 gt 5 5 53 next a Entry via touchscreen keypads enter your User ID and press next b Entry via bar code scanner scan your User ID The IRMA TruPoint will automatically advance to the next screen 5 a If the analyzer was powered on by MENU touching the screen the main menu will ae Tost re Joel display Press
153. tems that can be entered with each test Test Information includes oxygen therapy patient ID patient temperature patient hemoglobin sample type sample site patient notes and QC notes Each Test Information item may be turned on or off See Section 7 Calculations for patient hemoglobin setup instructions Test information entered with a test is permanently stored with the test record will appear on the results printout and can be transferred to idms Setting up the test information items that may be entered with each patient test 1 Highlight Test Information from TEST TEST SETTINGS SETTINGS and press edit A 2 Highlight the test information option of choice from the picklist and press edit 3 Select from the setup choices displayed on the Test mtormation screen The options available for each entry option item are described below Patient Temp he i Sample Type edit Optional we Length 1 20 done Oxygen therapy There are 3 oxygen therapy options Off No oxygen therapy information may be entered with a test FIO Only FIO may be entered with a test e Detailed Input Detailed oxygen therapy information may be entered with a test Refer to Section 2 Oxygen Therapy Information Entry for instructions on oxygen therapy information entry during a test 7 6 Patient ID There are 3 patient ID options e Off No patient ID information may be entered with
154. the analysis completes before the patient ID is entered a flashing ANALYSIS COMPLETE message displays in the upper right corner of the Patient ID screen Results will not display or print until a Patient ID is entered and next is pressed This screen cannot be bypassed the only way to exit this screen is to enter a Patient ID If a Patient ID has not been entered no results were displayed or printed and IRMA TruPoint powers down the test results may be viewed and printed by recalling the result If the test being recalled was the last patient test performed on the analyzer a patient ID can be entered upon recall Refer to Section 4 Recall Patient Results for instructions on recalling last test result If the test being recalled was not the last patient test performed on the analyzer the results can be viewed or printed but a patient ID cannot be entered Refer to Section 4 Recall Patient Results for instructions on recalling test results A configuration option may have been selected by the QA User which defines the minimum and maximum number of characters that must be entered for a valid Patient ID If the ID entered does not conform to the defined ID length an Invalid Length message will display Enter a Patient ID of acceptable length MDRD GFR e Ifa CR test is being performed and the QA User has selected the GFR calculation settings the user can enter information to obtain the GFR or they can skip the GFR
155. ther to enter a one to twelve character free text sample site Press next e Ifthe sample site selected is Brachial Femoral or Radial highlight right or left and press next FIO e Ifa blood gas test is being performed and the QA User has selected the Oxygen Therapy setting FIO2 only an FIO value may be entered Press next to accept the FIO displayed or enter a new FIO value Press next 2 15 Patient Hemoglobin L 15 wa 2 9 i ee OY OE OO UC Ca meer em OS on O SI J artoriat Venous Sue O hamid Neonate 2 next Sample Site 5 F102 i ee ee ee ee ee o TEST INFORMATION ENTRY MISCELLANEOUS If test information entry is completed before calibration is complete the operator is automatically returned to the Calibrating screen L Sample Site If calibration completes at any time during test information entry the CALIB COMPLETE Qe sO Ce message appears in the upper right corner of the Q Bracwiat cora _ l test information screen Complete information Q remem omer C ooe entry or press next through each remaining screen to save entries and return to the Calibration Complete Inject Sample screen None of the information screen entries will be saved until next is pressed on the last entry screen Pressing back to return to the Calibration Calibration Complete or Analyzing scre
156. this calculated value in further calculations such as shunt fraction or by assuming that the value obtained is equivalent to the oxyhemoglobin fraction O Sat 100 pO gt 4 67 07 pO2 gt 2121 pO gt 8532 x pO2 pO2 4 67 07 pO gt 3 2396 pO 2 31350 x pO gt 936000 gt pOy pO x 10 048 PH 7 4 Total Hemoglobin Total Hemoglobin tHb is estimated from hematocrit using the following equation tHb g dL Het x MCHC 100 gt MCHC Mean Corpuscular Hemoglobin Concentration is assumed to be 34 g dL gt tHb mM tHb g dL 1 6114 pH Normalized Ionized Calcium pH Normalized iCa results can be reported for pH values between 7 2 and 7 6 pH Normalized iCa results represent the iCa result normalized to a pH value of 7 400 using the following equation iCa N iCa 1 0 53 x 7 4 pH C 5 Patient Temperature Correction 89 10 Patient temperature can be entered into the IRMA TruPoint analyzer if it deviates from 37 C The measured pH and blood gas values are recalculated at the input temperature T with the following equations PH qy PHa o 0 0147 T 37 0 0065 7 40 pH 37 T 37 pCOx7 PCO437 x 190 019 T 37 Severinghaus pO equation 5 49107 1 p0 3 8840 071 A Temp 9 72 10 9 pO gt 8842 30 PO gt Final PO 10 gt A Temp is T 37 Kelman Nunn pO equation PO pina PO x 1010 0052 0 027 1 10 0 13 100 0Sat
157. though the temperature is monitored continuously during patient testing the Temperature Card allow for easy external verification 3 2 QUALITY CONTROL RECOMMENDATION Following method verification and establishment of liquid quality control limits ITC 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 ITC recommends that QC be performed as follows RUN AN EQC TEST Once per shift of patient testing on each analyzer When the analyzer experiences a significant change in storage temperature e g movement from a cold to a hot environment Whenever the performance of the analyzer requires verification according to facility or regulatory agency protocol Jah TWO LEVELS OF LIQUID CONTROL 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 is not required for each analyzer in use ADDITIONAL LIQUID CONTROL TESTING Is required only if cartridges are required to go through an additional equilibration period due to temperature fluctuations of greater than 8 C 14 4 F in the cartridge storage area Refer to Section 1 Cartridge Equilibration Procedure for additional equilibration information If cartridges are required to go
158. through an additional equilibration period run two levels of liquid control before putting the cartridge lot back into use RUN A TEMPERATURE TEST Monthly to verify that the IRMA TruPoint temperature control system is operating properly 3 3 ELECTRONIC QUALITY CONTROL Electronic Quality Control tests may be performed two ways 1 Manual EQC Test initiated by user by pressing the EQC button on the QC Test Options screen 2 Automatic EQC Test runs automatically per a pre configured schedule This feature requires the use of an AC adapter to power the IRMA TruPoint PERFORMING A MANUAL EQC TEST Turn IRMA TruPoint Analyzer On 1 Touch the right hand edge of the screen to turn the analyzer on Enter User ID optional 2 If the User ID option has not been activated go to step 4 3 If the User ID option is activated the Enter or Scan ID screen will display The User ID may be entered using either the alpha numeric keypads or the bar code scanner a Entry via touchscreen keypads enter your User ID and press next Enter or Scan ID b Entry via bar code scanner scan your User ID The IRMA TruPoint will automatically advance to the next screen Initiate an EQC Test 4 Press QC Test on the main MENU The QC TEST OPTIONS menu displays 5 Press EQC on the QC TEST OPTIONS menu to initiate the EQC test 6 The Analyzing screen appears indicating that the dia
159. tion e Do not remove battery from charger until it is fully charged doing s may result in less than optimal battery performance 6 3 CONDITIONING THE BATTERY For optimal battery performance perform a conditioning charge e Prior to initial use e Monthly or more frequently as the schedule allows e If the battery icon fails to display in the upper right corner of the touchscreen or if a fully charged battery yields fewer than the expected number of tests Condition batteries as follows 1 Insert a battery into the battery charger The battery should click into the charger when properly inserted The yellow light indicates that the battery is charging Charge the battery for 24 hours 2 After 24 hours remove the battery from the charger then reinsert the battery into the charger Leave the battery in the charger until the green light flashes continuously indicating that the battery is fully charged The battery should remain in the charger until it is needed for use in the analyzer ANALYZER MAINTENANCE CHANGING THE PRINTER PAPER The printer paper should be replaced when a red stripe displays on the side of the roll Instructions automatically appear on the screen when the printer door is removed Press next from the first screen to see additional instructions ote Do not remove the printer door while a test is in progress Change the printer paper as follows Figure sa 1 Remove the print
160. tions screen Press edit Total Users 151 done 3 Enter the new QA User ID Press next iri add Deer 1D abe next 4 Highlight button next to QA on the User ta Vse Privileges Privileges screen Press next an General Gluc Strip A Me Mee 7 20 USER ID OPTIONS QA Users can access the User ID Options screen by pressing User ID on the SETTING OPTIONS menu To access a User ID setting highlight the desired option from the picklist and press edit User ID There are 2 User ID options e Off Entry of a valid User ID is not required prior to performing tests e On Entry of a valid User ID is required prior to performing tests 1 Highlight the on or off button If on selected go to step 2 2 The Print ID setting determines whether or not the User ID associated with a test appears on the results printout Select on or off and press done Add User 1 Add new User ID Press next 2 Highlight button next to desired privileges category and press next to save entry Edit user privileges 1 Enter User ID to be edited Press next 2 Highlight button next to desired Privileges category and press next to save entry Delete user 1 Enter User ID to be deleted Press next 2 Press ok from confirmation screen to complete deletion Print lists 1 Highlight button s next to desired Privileges categories and press print 2 Press print from the
161. to correlate IRMA TruPoint hematocrit results to a reference method Date Format Date may be displayed in the following formats MM DD YY YY MM DD or DD MM YY Date and Time Allows the definition of the correct date and time The default analyzer date and time is U S Central Standard Time Electronic QC EQC Quality control is performed through a comprehensive diagnostic check of the IRMA TruPoint edge connector internal electronics and analyte circuitry EQC minimizes the use of reagents and disposable cartridges required for liquid QC testing EQC can be configured to run automatically when the analyzer is powered by the AC adapter Oxygen Therapy Information Allows optional entry of patient oxygen therapy information to be associated with a patient blood gas test record Patient ID Allows optional or required entry of a patient ID when performing a patient test ID lengths number of characters may also be defined Patient Hemoglobin Allows optional entry of a hemoglobin value or use of the calculated tHb value derived from an IRMA TruPoint hematocrit result for the associated patient to be used in the BEb calculation when running a blood gas test Patient Notes Allows optional entry of up to 3 pre defined patient notes to be associated with a patient test record 1 13 QC Notes Allows optional entry of up to 3 pre defined QC notes to be associated with a QC test record QC Limits Allows optional definition of
162. to exposure to room air e A sample was improperly stored gt Samples chilled prior to analysis may result in falsely elevated potassium values due to potassium leakage from erythrocytes and other cells gt Samples for pH and blood gases were not analyzed within 5 minutes of collection and were stored at room temperature resulting in value changes A 1 Delayed tourniquet release during venipuncture can result in falsely elevated potassium values or dilution effects Hemolysis during sample collection can result in falsely elevated potassium values The sample was drawn in a syringe that is not compatible with the IRMA TruPoint system See Section 2 Syringe Requirements The sample was not well mixed prior to sample analysis The sample was not injected forcefully enough to displace the calibrant Improper injection technique introduced bubbles into the sample path bubbles were not displaced from the sample path prior to analysis phase Effects of Physiological Conditions on Test Results Blood from patients receiving certain therapeutic treatments or with certain physiological conditions can interfere with the performance of blood sensors Refer to standard documents such as Effects of Diseases on Clinical Laboratory Tests for more information Accuracy of conductivity based hematocrit measurements are dependent on a specific range of white blood cell count and total protein concentration Total protein levels
163. tten warranty shall be the exclusive remedy of the purchaser for any defect in the product of the Company Any purchaser of an ITC product agrees that ITC will not be liable for any other expenses including but not limited to incidental or consequential damages and loss All obligations of the Company shall terminate one 1 year after date of original shipment H 1 Warranty Disclaimer Every ITC product carries an express written limited warranty which is the only warranty express or implied of any ITC product ITC disclaims all other warranties including implied warranties of merchantability or fitness H 2
164. uitable Note e as defined in the above standards the classification of Not Suitable is not intended to indicate that the instrument is not suitable for use in an Operating Room OR environment Rather it is intended to indicate that the instrument is not suitable for use in the direct presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Device Disposal at end of useful life The analyzer and accessories may be returned to ITC Nickel Metal Hydride NiMH batteries are classified as a non hazardous waste and should be disposed of in accordance with the local state or federal regulations where they are used Contact your local government for disposal practices in your area Although NiMH batteries are considered environmentally friendly they may also be recycled Recycling options available in your local area should be considered when disposing of this product or batteries may be returned to ITC for recycling B 2 Environmental Conditions for Vac Powered Equipment Table B 2 The AC adapter and battery charger are intended for indoor use and operation They should be transported and used within the following conditions Temperature Range 5 40 C 41 104 F Relative Humidity Range 0 80 Voltage and frequency No greater than 10 of the main fluctuations power source Electromagnetic Emissions and Immunity continued Table B 3 CISPR 11 1997 w A1 1999
165. ume of 125uL Each device consists of a capillary tube and a plunger which is packaged separately The capillary tube fills via capillary action until the sample contacts the white plug The upper end of the capillary tube is sealed when blood contacts the white plug preventing the sample from running back out the tip of the device during handling see Figure F 1 Following sample collection the plunger is inserted into the capillary tube and the device is attached to the IRMA TruPoint cartridge Luer port The sample is introduced into the cartridge by quickly and completely depressing the plunger in one smooth motion until it stops Figure F 1 capillary tube plunger A ER D I l N B D E A Capillary tube tip round end where blood enters the capillary tube B Sample channel C Square flange D White plug E Capillary tube barrel square end where plunger inserts F 1 WARNINGS AND LIMITATIONS OF USE Read instructions for the IRMA TruPoint system and capillary device before use e For in vitro diagnostic use only e For capillary sample collection and analysis This device is not sterile and is not intended to be used as a syringe e Blood sample collection must be performed under proper medical supervision Avoid excessive squeezing of the puncture site to prevent sample hemolysis and contamination of the sample with tissue fluid Tissue fluid may dilut
166. unction Activating deactivating the correlation setting 1 Highlight Correlation from TEST SETTINGS TEST SETTINGS and press edit An Attention message appears Test information a stating that adjusting correlation factors will Bypass Correlation Y edit affect future patient test results Press ok aone Highlight the desired Product Type and press Sy Select Product Type edit zm oon at ne Y edit Correlation ON gt F Highlight on or off button and press next gt gt gt Corretation cc If on is selected go to Establishing or cane Changing Correlation Factors CH ori next 7 9 Establishing or changing correlation factors 1 Ensure that Correlation is on see previous section Press next from Correlation screen 2 Correlation for each analyte can be configured _ seteet ansivee independently from the Select Analyte screen mm a Highlight the first analyte in the picklist for poz D which correlation factors are to be entered Sipe 0 99 The current slope and intercepts for the highlighted analyte will appear below the picklist If the Correlation mode is being accessed for the first time the default values appear If the factors have been changed previously the current values display If a record of these existing correlation settings is desired the operator should transcribe the data before moving to the next step Existing
167. upplies buildings used for domestic Flicker Emissions purposes TEC 61000 3 3 Guidance and Manufacturer s Declaration Electromagnetic Immunity The IRMA TruPoint Blood Analysis System AC adapter is intended for use in the electromagnetic environment specified below The customer or the user of the IRMA TruPoint Blood Analysis System AC adapter should assure that it is used in such an environment Immunity Test TEC 60601 Test Compliance Level Electromagnetic Level Environment Guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or Discharge ESD 8 kV air 8KkKV air ceramic tile If floors are covered TEC 61000 4 2 with synthetic material the relative humidity should be at least 30 Electrical fast 2 kV for power 2 kV for power Mains power quality should be that transient Burst supply lines supply lines of a typical domestic commercial or TEC 61000 4 4 1 kV for input output 1 kV for input hospital environment lines output lines Surge 1 kV differential 1 kV differential Mains power quality should be that TEC 61000 4 5 mode mode of a typical domestic commercial or 2 kV common mode 2 kV common mode hospital environment Voltage dips lt 5 UT lt 5 UT Mains power quality should be that short gt 95 dipin Ur for gt 95 dip in Uy for of a typical domestic commercial or interruptions and 0 5 cycle 0 5 cycle hospital
168. utes If more than 4 minutes elapse the test is terminated and an Error message appears Note e If an Error screen appears during calibration refer to Section 5 Troubleshooting for assistance 3 10 17 After cartridge calibration is complete open the ampule Immediately draw the sample into a 1 3 mL non heparinized syringe through an 18 20 gauge needle Place the needle opening below the liquid surface when drawing the sample to minimize air contamination Draw approximately 1 mL into a 1 mL syringe or all but the last bit of ampule contents into a 2 mL or 3 mL syringe When done remove the needle from the syringe Do not attempt to invert the syringe or to expel gas bubbles from the syringe 18 Remove the luer Cal cap from the injection port and firmly attach the syringe to the cartridge Immediately inject the sample using the technique described in Section 2 Injecting a Syringe Sample Inject all but the last bit of syringe contents into the cartridge taking care not to inject an air bubble into the cartridge Note e If air bubbles or calibration gel are present in the sample path after the initial sample injection remove them by injecting additional sample from the same syringe or by lightly tapping the top of the syringe plunger and then injecting additional sample from the same syringe e If air bubbles or calibration gel cannot be removed from the sample path press cancel to stop the test discard the cartridge
169. vailable for the selected Product Type The analytes available and control expiration date are Select Control torera 44999 back Lovel 1 53023 4 ot Level 253033 Lovel 2 53040 v tavara zasea ABG Na K iCa 11 08 went shown below the picklist for the highlighted control Highlight the desired control and press next b3 Enter first and last search dates b4 The Output Type screen allows selection of Result detailed report or Table summary report Result Output Selected The QC Results Found screen displays a picklist with test dates and times Scroll through the list of results until the desired result is highlighted The product type and QC lot level and analytes are shown below the picklist for the highlighted result Press print all to print a detailed hard copy for all results found in the picklist Press view to see the results for the highlighted result only The options from the QC Results screen are Output Type Result back Table 2 sessesve rar gan one 12 40 4 ad QC Results Found 12 12 02 10 33 v view saasina san Het Nas Ke ICa done CC Li Lot 12345 QC Test Results CC L1 Lot 12485 14 21 Suns tutto ia 11 14 iza gt print Prints a hard copy of the QC test results selected gt limits Displays QC limits if they have been established by the QA User gt done Returns to QC RESULTS FOUND menu Table Output S
170. y that test procedures are being followed 4 If a high rate of sensor errors persists clean the IR probe and edge connector see Section 6 Maintenance 5 If a high rate of sensor errors persists run an EQC test and call your service provider for assistance 5 4 SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE PROCEDURAL ERRORS Cartridge removed Cartridge was removed Dispose of the cartridge and retest with prematurely during a test or was not a new cartridge Fully insert the completely inserted cartridge and do not remove cartridge during test Time for data entry Data was not completely Remove and dispose of the cartridge expired entered within the allotted Retest with a new cartridge making time period following required entries within allotted time cartridge insertion period Sample injection time Sample was not injected Remove and dispose of the cartridge expired and or test button was not Retest with a new cartridge Inject Temperature Card removed prematurely pressed within 4 minutes of Calibration Complete message display Temperature Card was removed while a temperature test was in progress sample and press test within required time period Press ok to return to the QC Test Options menu Repeat temperature test without removing the Temperature Card during the test ENTRY ERRORS Lot Product Type mismatch Lot Cal Code mismatch
171. your service provider 5 3 PROBLEM CORRECTIVE ACTION S EQC FAILURES 1 Clean edge connector and IR probe See Section 6 Maintenance 2 Repeat EQC test 3 Call your service provider TEMPERATURE TEST FAILURES 1 Clean IR probe See Section 6 Maintenance 2 Verify that the correct Temperature Card cal code is used 3 Verify that analyzer and Temperature Card have equilibrated to room temperature If a temperature test fails wait at least 1 minute before re testing with the same Temperature Card 4 Repeat temperature test using same Temperature Card if temperature test fails again use a different Temperature Card if available 5 Clean the Temperature Card See Section 6 Maintenance 6 Call your service provider TROUBLESHOOTING SPECIFIC OPERATING PROBLEMS A screen message signals the presence of a specific operating data entry or screen selection problem or condition explains its probable cause and guides the user through the resolution process If necessary call your service provider for assistance SCREEN MESSAGE REASON FOR MESSAGE CORRECTIVE ACTION SENSOR ERRORS Sensor error Use new cartridge or SUPPRESSED RESULT Analyte value displays 66 Displays upon receipt of a sensor error during testing 1 Remove and dispose of the cartridge retest with a new cartridge 2 Verify that cartridges are properly equilibrated 3 Verif

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