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.
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Table of Contents Section Page 1. The IRMA TruPoint® Blood Analysis System 1.1 Introduction 1.1 Intended Use System Overview CLIA Complexity Classification Implementation 1.1 1.1 1.1 1.1 System Components 1.2 System - Major Components IRMA TruPoint Blood Analyzer IRMA TruPoint Battery Charger and Power Supply IRMA TruPoint AC Power Adapter IRMA TruPoint Cartridges 1.2 1.3 1.4 1.5 1.6 Getting Started 1.
Section Page 2. Patient Sample Analysis 2.1 Overview 2.1 Sample Requirements 2.1 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 2.1 2.1 2.2 2.2 2.2 2.2 2.3 2.3 Sample Injection 2.4 Injecting a Syringe Sample Injecting a Capillary Sample 2.4 2.6 Patient Test Procedure 2.6 Performing a Patient Test 2.
Section Page 3. Quality Control Testing Overview 3.1 3.1 IRMA TruPoint Quality Control 3.2 Quality Control Recommendation 3.3 Run an EQC Test: Run Two Levels of Liquid Control: Additional Liquid Control Testing: Run a Temperature Test: 3.3 3.3 3.3 3.3 Electronic Quality Control 3.4 Performing a Manual EQC Test Automatic EQC Test 3.4 3.6 Liquid Quality Control 3.6 Liquid QC Material Requirements Performing a Liquid Control Test Initiate Liquid QC Test 3.6 3.7 3.7 Temperature test 3.
Section Page 5. Troubleshooting 5.1 Overview 5.1 Troubleshooting General Operational Problems 5.2 Troubleshooting Specific Operating Problems 5.4 6. Maintenance 6.1 Overview 6.1 Battery Maintenance 6.1 General Instructions Removing the Battery Charging the Battery (Routine) Conditioning the Battery 6.1 6.3 6.3 6.4 Analyzer Maintenance 6.4 Changing the Printer Paper Calibrating the Barometer 6.4 6.5 Cleaning System Components 6.
Section Page Correlation Bypass Correlation Display Units Reference Ranges Reportable Ranges 7.8 7.11 7.12 7.12 7.14 Quality Control (QC) Settings 7.15 QC Lockout Controls 7.15 7.17 User ID Settings 7.19 Default QA User ID Adding a New QA User ID User ID Options 7.20 7.20 7.21 Device Settings 7.22 Beeper Calibrate Barometer Communications Date Format Date/Time Auto Print Screen Contrast VueLink 7.22 7.22 7.23 7.27 7.27 7.28 7.28 7.28 8. Appendixes A: Limitations and Safety Precautions A.
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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 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.
IRMA TRUPOINT BLOOD ANALYZER Figure 1-2 A. Carrying Handle B. On-board Printer: provides hard copies of test results and information. C. Rechargeable Battery: provides portable analyzer power. D. 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. E. Edge Connector Block: electronically connects the cartridge to the analyzer.
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. • 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 30-40 tests when fully charged.
IRMA TRUPOINT AC POWER ADAPTER The IRMA TruPoint analyzer can be operated on AC power using the IRMA TruPoint AC power adapter. • The analyzer will not automatically shut off when the AC adapter is in use, and can be left on indefinitely. • 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.
IRMA TRUPOINT 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.
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 materials are not available, contact your service provider to order a replacement.
UNPACK THE IRMA TRUPOINT CARTRIDGES IRMA TruPoint 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 TEMPERATURE OPERATING RANGE The IRMA TruPoint temperature operating range is 12-30°C (54-86°F). • 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.
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 during power-up. Continue to press down (logo will flash off) until the Select Language screen appears. 2.
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 Select Product Type screen during a patient test.
Note: • 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: • Identify QA User(s) to supervise IRMA TruPoint setup and monitoring.
• 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.
• 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 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.
• User ID: Requires entry of a valid User ID prior to performing select functions. • VueLink: 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.
Bar Code Scan Symbologies The bar code reader is factory programmed to read the following bar code symbologies: Code 11 Code 39 Code 128 Codabar EAN/JAN Interleaved 2 of 5 Matrix 2 of 5 MSI Plessey Telepen UPC Scanner Specifications Refer to the User’s Guide that came with the bar code reader for detailed specifications and regulatory compliance statements. Note: • The Welch Allyn bar code reader uses a non-laser, red LED light source. Connecting the Bar Code Reader 1.
Figure 1-7 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.
1. Enter User ID (optional). 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. 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 the appropriate time.
Transmitting Results to VueLink 1. The patient test results displayed on the Results screen are transmitted to VueLink when done is pressed, only under the following conditions: • 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. 2.
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.
3. a. If the Communications Method setting is User Selects, highlight the button next to the appropriate method and press next and go to step 4. b. If the Communications Method setting is not User Selects, go to step 4. 4. Connect cable to computer and verify that DeviceCom is running. Select an option on the Device Update screen: a. “receive all” - All profile settings will be sent to the analyzer, overwriting the existing settings.
c. Result Transfer setting is “host” and there are unsent results. > Results must be manually transferred to the host system before the update can be initiated. Press ok to return to the main MENU. d. Result Transfer setting is “off” and there are unsent results. > 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 that they may be deleted. > Press cancel to cancel update and retrieve results.
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 requirements, 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.
CAPILLARY REQUIREMENTS Capillary samples must be collected in the IRMA TruPoint Capillary Collection Device. See Appendix F for detailed Capillary 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.
• 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 HANDLING • 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.
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).
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 out of the sample path and into the waste area. Note: • Do not pull sample from the waste area back into the sample path. Doing so may cause inaccurate results. Figure 2-3 Bubbles or Calibrant in Sample Path bubbles calibrant enzyme pad A. B. C.
5. Once the sample path is completely 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.
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: • 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 next.
Do not touch the cartridge leads after the tape has been removed. Do NOT remove the luer cap from the cartridge. (Figure 2-4). 10. Fully insert the cartridge into the analyzer within 15 minutes of opening the package. (Figure 2-5) Note: • 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. Figure 2-5 Verify/Enter Cartridge Information 11.
b2. To enter a new cartridge Lot for the first time, highlight new from the picklist and press edit. › Enter the cartridge Lot using the alpha keypad. Press next. › Enter the Cal Code using the alpha keypad. Press next to return to the Verify Information screen. If the information is correct, press next to continue patient test. If the information is incorrect, press edit to re-enter the Lot and Cal Code.
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 calibrant, and press next.
Note: • 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. • 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.
a. Result outside of reference range: If reference ranges were established by the QA User, and a patient test result falls outside of the defined limits, the result will be flagged “H” (High) or “L” (Low). b. Result outside of reportable range: If a measured result is outside of the IRMA TruPoint reportable range, that result, and any corresponding calculated results, will be flagged “<” (less than) or “>” (greater than). c.
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.
Note: • 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 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.
Patient Temperature • The Patient Temperature option allows entry of a patient temperature when performing a blood gas test. A default temperature of 37°C automatically displays if a patient ID is not entered, 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.
TEST INFORMATION ENTRY – MISCELLANEOUS If test information entry is completed before calibration is complete, the operator is automatically returned to the Calibrating screen. If calibration completes at any time during test information entry, the CALIB. COMPLETE message appears in the upper right corner of the test information screen. Complete information entry, or press next through each remaining screen to save entries and return to the Calibration Complete, Inject Sample screen.
Patient Status • Highlight the appropriate Patient Status setting. › If Code or Room Air status is selected, press next to accept the selected oxygen status and complete entry. › If Pump status is selected, press next to access the FIO2 screen. Enter FIO2 value and press next to access Comments screen. Enter a one- to twelve-character comment (optional) and press next to complete entry. › If the Oxygen status is selected, press next to access the Oxygen Therapy screen.
• The following information may be entered: › If Venturi, Trach Collar, or High Flow is selected, enter the FIO2 (%) and press next. › If Simple or NRB is selected, enter the oxygen flow (L/min.) and press next. › If Other is selected, enter mask type (up to twelve characters); enter the oxygen flow (L/min.) and press next. Nasal Cannula Mode • The Oxygen Flow screen appears following selection of Nasal Cannula from the Oxygen Therapy screen. Enter the oxygen flow (L/min.) and press next.
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.
QC LOCKOUT The QC Lockout feature allows the QA User to define the number of successful QC tests (EQC and/or liquid) required to support 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.
• Some, but not all, Product Types are completely locked-out for all analyte groups available on that product. A padlock will display over the selection button, preventing selection of that product type until QC lockout requirements have been satisfied. › Select a product type that is not locked out and press next to continue test; or › Press cancel to return to main.
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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.1 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.
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.
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.
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.
a. Passed EQC Test: Manual a1. Press view to view quantitative results (optional). Press next from each screen to proceed through results for all analytes. 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.
Note: • 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.
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: • 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.
Select Product Type 6. Highlight the desired product type and press next. The Insert Cartridge screen displays. Note: • 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.
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 type (Type) displayed on the Verify Information screen is correct. If the 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.
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 sensors. 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.
17. After cartridge calibration is complete, open the ampule. Immediately draw the sample into a 1-3 mL non-heparinized syringe through an 1820 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.
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 allows pre-defined notes to be permanently associated with individual QC test records.
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: • 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.
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.
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.
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 the PATIENT RESULTS menu. This menu displays the following options: Returns to main MENU. Returns to RECALL menu. last: Displays results for the last patient test performed. search: Allows search of results by date and/or patient ID.
2. Screens that appear are based on search criteria selection: a. Search by Date: a1. 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.
a1. print: Presents the Printing Patient Results screen that displays the total number of patient results found and the number of the result currently printing. 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.
QUALITY CONTROL RESULTS From the RECALL menu, press QC to access the QC TEST RESULTS menu. This menu displays the following options: 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. Menu: Recalling “Last” QC Test Results 1. Press last from the QC TEST RESULTS menu. Results display for the last QC test performed, regardless of QC type.
a3. The QC Results Found screen displays a picklist of all the QC tests that meet the search criteria, and the test dates and times. Scroll through the list of results until the desired result 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.
b2. The Select Control screen displays a picklist with the control lots and levels available for the selected Product Type. The analytes available and control expiration date are 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).
› 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: • Refer to Section 3-Quality Control of the SureStep®Pro Glucose Module User Manual for glucose QC test recall instructions. 4.
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 conditions.
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.
2. The Automatic Results Transfer option is configured “on”. 3. The IRMA TruPoint analyzer is operated with the AC adapter. Automatic Results Transfer will not initiate when the analyzer is powered by battery. 4. 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.
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Section 5 Troubleshooting OVERVIEW The IRMA TruPoint Blood Analysis System troubleshooting information is organized to address both general and specific operating problems. General 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).
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 • Analyzer does not turn “on” when right-hand edge of screen is pressed 1. Verify that the battery is installed, or that AC adapter is plugged into a working outlet. 2. Try again, pressing more firmly or longer on the screen. 3.
PROBLEM CORRECTIVE ACTION(S) PRINTER PROBLEMS • Poor print quality 1. Only use paper supplied by your service provider. 2. 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. • Printer paper advances, but 1. Only use paper supplied by your service provider. nothing is printed (printer sounds 2.
PROBLEM CORRECTIVE ACTION(S) EQC FAILURES 1. Clean edge connector and IR probe. See Section 6Maintenance. 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.
SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE PROCEDURAL ERRORS “Cartridge removed prematurely” Cartridge was removed during a test or was not completely inserted. Dispose of the cartridge and retest with a new cartridge. Fully insert the cartridge, and do not remove cartridge during test. “Time for data entry expired” Data was not completely entered within the allotted time period following cartridge insertion. Remove and dispose of the cartridge.
SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE TEMPERATURE ERRORS “Cartridge out of temperature range” Cartridge temperature was Remove and dispose of the cartridge; re-test with a new cartridge within outside of the acceptable temperature operating range temperature operating range. (12°-30°C / 54°-86°F). “Analyzer out of temperature range” Analyzer temperature was outside of the acceptable temperature operating range (12°-30°C / 54°-86°F).
SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE 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”. 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.
SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE DATA TRANSFER “Unable to Transfer - No test results to upload” A. send was pressed when there are no unsent records in the analyzer memory. Press the appropriate button, depending upon the transfer status of the results in the analyzer memory. B. resend was pressed when there are no previously sent records in the analyzer memory. “Unable to Transfer Transfer unsuccessful” Data transfer between the analyzer and receiving system was unsuccessful. 5.
SCREEN MESSAGE REASON FOR CORRECTIVE ACTION MESSAGE MISCELLANEOUS Displays when adding a Press ok to return to the picklist of “Unable to Add Maximum number have control via QC Settings and existing controls to allow deletion of one or more controls. the maximum number of been entered” controls (42), have already been defined. “Lot expired” Expired cartridge lot was entered via Test Settings, QC Test, or Patient Test. Use an in-date cartridge lot.
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Section 6 Maintenance OVERVIEW This chapter describes the routine and preventative 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.
• 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: • 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).
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 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.
CONDITIONING THE BATTERY For optimal battery performance, perform a conditioning charge: • Prior to initial use; • Monthly, or more frequently as the schedule allows; • 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. 2. Insert a battery into the battery charger. The battery should ‘click’ into the charger when properly inserted.
4. Place the spindle into the cradle in 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) 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.
CLEANING THE BATTERY CHARGER, POWER SUPPLY, AND ANALYZER SURFACES 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 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.
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, remove the right and left cartridge guides by pulling them straight forward and off of the cartridge insertion porch area. (Figure 6-6) 3.
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. • QA Users have access to all system settings menus. • 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.
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: • 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.
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, pCO2, pO2) and/or Hct/Lytes (Na+, K+, 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.
5. Enter the Cal code and press next to return to the Lot picklist. Press done to return to TEST SETTINGS. Note: • 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 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.
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 used in all BEb calculations. b. Manually Entered value: User manually enters a patient hemoglobin value with each test. c.
• Selecting a pO2 Temperature Formula: 1. Highlight the button next to the formula to be used in the calculation of patient temperaturecorrected results. These formulas are further described in Appendix C. TEST INFORMATION QA Users can define the Test Information items 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.
Patient ID There are 3 patient ID options: • Off: No patient ID information may be entered with a test. • 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 1 and 20 characters).
Setting up Patient Notes: 1. Turn Patient Notes “on” and press next. 2. Default or established patient notes appear in a picklist. a. Deleting Patient Notes: Highlight the desired note and press delete. b. Adding Patient Notes: Press add and enter a new note via the touchscreen keypad. 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.
Collecting Correlation Data: 1. Ensure that the Correlation option is “off” when collecting correlation data. 2. Ensure that the reference analyzer is properly maintained prior to the start of data collection to ensure accurate correlation. 3. 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.
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 independently from the Select Analyte screen. Highlight the first analyte in the picklist for which correlation factors are to be entered. The current slope and intercepts for the highlighted analyte will appear below the picklist.
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 from a statistically valid number of samples.
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 SETTINGS and press edit. 2. Highlight the test parameter of choice from the 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.
c. Select desired analyte from the picklist. If reference ranges will be entered for multiple analytes, select “All”. Press edit. d. Enter the lower reference limit and press next. e. Enter the upper reference limit and press next. f. Continue for all appropriate analytes. When complete, press done. 3. 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.
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.
QUALITY CONTROL (QC) SETTINGS QA Users can access QC Settings by pressing QC from the SETTING OPTIONS menu. The following options are presented: Returns to main MENU. Settings: Returns to SETTING OPTIONS menu. QC Lockout: Allows definition of the number of electronic (EQC) and/or liquid (LQC) quality control tests required to support patient testing. Controls: Allows set-up of new controls and editing or deletion of established controls for IRMA TruPoint cartridge and SureStepPro Glucose Module tests.
• When NO liquid QC limits have been established, running the designated number of controls will satisfy QC lockout requirements, for all nonsuppressed 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.
Setting up or modifying QC lockout schedule 4. The Analyte Lockout screen displays the current settings for the first analyte/analyte group available on the product type selected. Press “on” to activate or “off” to deactivate 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.
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. Press QC on the SETTING OPTIONS menu. 2. Press Controls on the QC SETTINGS menu. 3. Highlight the product type of choice. Press next. 4. The Controls screen displays a picklist of current controls. Press add for a new control. 5.
Editing an established control 1. Press QC on the SETTING OPTIONS menu. 2. Press Controls on the QC SETTINGS menu. 3. Highlight the product type of choice. Press next. 4. The Controls screen displays a picklist of current controls. Highlight the control to be edited, and press limits. 5. The analyzer displays the current limits for the highlighted control. Press edit and follow the series of entry screens to edit control expiration date, analytes to be reported for the control, and control limits.
> QA Users have access to all analyzer setting and testing functions, including User ID settings. > General Users may perform and recall all tests, (as configured by QA User), but have limited access to analyzer set-up functions. > 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.
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: • Off: Entry of a valid User ID is not required prior to performing tests. • 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.
DEVICE SETTINGS Device Settings determine the operating functions for the IRMA TruPoint system. • Non-QA Users can access and change the beeper, date format, time, printer, and screen contrast functions. • 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 menu by pressing Device from the SETTING OPTIONS menu.
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 • Serial Port: An RS232 serial port is located on the backside of the IRMA TruPoint analyzer, below the printer.
Setting up communications 1. Highlight Communications in the DEVICE SETTINGS picklist. Press edit. 2. Select a data Communications Method. If more than one method will be used, select the User Selects option which allows selection of a communications method each time data 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.
b3. The Subnet Mask screen displays. This screen defines which bits are significant. 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”, “ccc”, and “ddd” are each a 1 to 3 digit value ranging from 0 to 255. Press next. b5. The Remote Port screen displays.
Note: • 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.
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. Configure Automatic Device Updates as follows: 1.
AUTO PRINT There are 3 auto print options: • 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. • Immediate: Test results and sample information entered during the test 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.
Appendix A Limitations 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.
• 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.
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.
Creatinine Substance (concentration) Expected Effect Acetaminophen (20 mg/dL) Increase creatinine by 0.2 mg/dL at creatinine levels <2 mg/dL. Results were variable at levels <8 mg/dL Creatine (> 5 mg/dL) Suppressed creatinine levels were observed at creatine levels >5 mg/dL. Hydroxy Urea (<500 µmol/L) Decreased creatinine results by approximately 0.2 mg/dL at normal creatinine levels. Iodoacetate (900 mg/dL) Decreased creatinine results by approximately 50% at both the 0.9 and 8.
Lactate Substance (concentration) Expected Effect Acetaminophen (20 mg/dL) Increase lactate by 40% at lactate levels <18 mg/dL. Acetaminophen (100 mg/dL) Increase lactate by 25% at lactate levels <18 mg/dL. Cysteine (10 mg/dL) Decreased lactate levels by 30%. Glycolic Acid (10 mM) Produces variable results at lactate levels <18 mg/dL. Hydroxy Urea (500 µmol/L) Decreased lactate results by approximately 30% at normal lactate levels <18 mg/dL.
SAFETY 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)]. • Both the cartridge and the collection device should be disposed of in a biohazard container.
5. Oesch et. al., "Ion-Selective Electrodes for Clinical Use", Clinical Chemistry, 1986, vol 32, no 8, p.1448. 6. National Committee for Clinical Laboratory Standards (NCCLS): Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture, Document H3-A 3,1991. 7. 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):322329, 1987. 8. Maas et. al.
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Appendix B System Specifications and Cartridge Information This appendix includes IRMA TruPoint system specifications and IRMA TruPoint cartridge information.
General Specifications, continued Table B-1 Category Specification Display: Liquid Crystal Display (LCD) touch screen Power Requirements: Cartridges: Analyzer: Battery Charger/Power Supply: AC Adapter: Empty Battery Recharge Cycle: none 7.2 V, 2 amp by rechargeable battery or AC adapter 100 - 240 Vac, 1 Amp, 50 - 60 Hz; The battery charger is a Class 1LED Product 100 - 240 Vac, 1.0 Amps, 50 - 60 Hz 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.
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.
Symbol Definitions Definitions for symbols that appear on IRMA TruPoint product labels are shown in Table B-4.
CARTRIDGE/ANALYTE CONFIGURATIONS IRMA TruPoint cartridges are available in the following analyte configurations: Table B-6 Cartridge Measured Calculated BG pH, pCO2, pO2 CC pH, pCO2, pO2, Hct, Na+, K+, iCa HCO3-, TCO2, BEb, BEecf, O2Sat HCO3-, TCO2, BEb, BEecf, O2Sat, tHb, iCa(N) H3 Hct, Na+, K+, iCa tHb H4 Hct, Na+, K+, Cl-, BUN/urea tHb GL Glu, Na+, K+, Cl- CR Creatinine LA Lactate MDRD GFR CARTRIDGE EQUILIBRATION TIMES Following removal from their shipping container, IRMA TruPoint ca
REPORTABLE RANGES The default reportable ranges for each parameter are shown in Table B-8*: Table B-8 Measured pH 6.000 - 8.000 pH units pCO2 4.0 - 200.0 mmHg (0.53 - 26.66 kPa) pO2 20.0 - 700.0 mmHg (2.67 - 93.33 kPa) Hct Na+ 10.0 - 80.0 % (.100 - .800 SI) K+ 1.00 - 20.00 (mM, mEq/L) iCa Cl- 0.20 - 5.00 mM (0.80 - 20.04 mg/dL; 0.40 - 10.00 mEq/L) 80.0 - 200.0 (mM, mEq/L) 30.0 - 150.0 (mM, mEq/L) BUN/urea BUN 3 - 150 mg/dL (1.1 - 53.5 mM) Urea 6 - 321 mg/dL (1.1 - 53.
DISPLAY RESOLUTION The display resolution for each parameter is as follows*: Table B-9 Measured Calculated pH 0.001 pH units HCO3- 0.1 mM pCO2 0.1 mmHg (0.01 kPa) TCO2 0.1 mM pO2 0.1 mmHg (0.01 kPa) Beb 0.1 mM Hct Na+ 0.1% (.001 SI) Beecf 0.1 mM 0.1 (mM, mEq/L) O2Sat 0.1 % K+ 0.01 (mM, mEq/L) tHb 0.1 (mM, g/dL) iCa Cl- 0.01 (mM, mEq/L, mg/dL) iCa(N) 0.1 (mM, 0.1 (mM, mEq/L) mEq/L, mg/dL) BUN/urea 1 mg/dL (0.1 mM) Glucose 1 mg/dL (0.1 mM) Creatinine 0.
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 pCO2 0 to 10.000 -999.99 to +999.99 mmHg -133.32 to +133.32 kPa pO2 0 to 10.000 -999.99 to +999.99 mmHg -133.32 to +133.32 kPa Na+ K+ 0 to 10.000 -999.99 to +999.99 mM, mEq/L 0 to 10.000 -9.999 to +9.999 mM, mEq/L iCa 0 to 10.000 -9.999 to +9.
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 site. The following published ranges should only serve as a guide.1,2 Table B-11 Measured Reference Range pH: 7.35-7.45 (arterial)1; 7.32-7.43 (venous) 1 pCO2: 35-48 mmHg/4.7-6.4 kPa (arterial) 1; 41-55 mmHg/5.5-7.3 kPa (venous) 1 pO2: 83-108 mmHg/11.1-14.
Calculated Reference Range HCO3-: 22-26 mmol/L (arterial) 1; 21-28 mmol/L (venous)3 TCO2: 19-24 mmol/L (arterial) 1; 22-29 mmol/L (venous) 3 BE: (-2) - (+3) mmol/L (arterial or venous)1 O2Sat: 94-98% (arterial) 1; 60-85% (venous) 2 tHb: 11.0-14.5 g/dL or 6.9-9.1 mmol/L (2-9 years) 1 12.0-15.0 g/dL or 7.5-9.4 mmol/L (9-12 years) 1 11.7-17.4 g/dL or 7.4-10.9 mmol/L (12-74 years, male) 1 11.5-16.1 g/dL or 7.2-10.
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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 concentration in whole blood as described in the following table.
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) › E is the voltage generated › E° is a constant for the sensor › S is the sensitivity of the sensor › C1 and C2 are the ion activities outside and inside the sensor membrane. The IRMA TruPoint system uses direct (undiluted) measurement methods.
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 parameters reported by the IRMA TruPoint system. The following equations are used to calculate each of the parameters: Bicarbonate 3,11 Two formulas are available for the calculation of bicarbonate: Severinghaus/ NCCLS or Siggaard-Andersen. Refer to Section 7-Calculations for instructions on formula selection.
Base Excess of Blood 4,12 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 instructions on formula selection. Severinghaus/NCCLS formula: BEb = (1-0.014 x Hb) [HCO3- -24.8 + (1.43 x Hb+7.
Oxygen Saturation6 Oxygen saturation (O2Sat) 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 pO2 and an assumed oxyhemoglobin dissociation curve. These results differ significantly from direct measurement.
Patient Temperature Correction7, 8, 9, 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(T) = pH(37°C) - 0.0147(T-37) + 0.0065(7.40 - pH(37°C))(T-37) pCO2(T) = pCO2(37°C) x 10(0.019{T-37}) Severinghaus pO2 equation: 5.49*10-11*pO23.88+0.071 ( Temp) 9.72*10-9*pO23.88+2.
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.
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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: 94 6.860 - 7.710 0.936 0.456 0.997 0.017 pCO2 Number of samples: Range evaluated (mmHg): Slope: Intercept: Correlation Coefficient (r): Sy.x: 94 4.4 - 149.4 0.972 0.
ACCURACY - CONTINUED Potassium (K+) Number of samples: Range evaluated (mM): Slope: Intercept: Correlation Coefficient (r): Sy.x: 137 1.5 - 13.8 0.961 -0.033 0.999 0.217 Ionized Calcium (iCa) Number of samples: Range evaluated (mM): Slope: Intercept: Correlation Coefficient (r): Sy.x: 137 0.80 - 5.70 1.019 -0.063 0.997 0.136 Chloride (Cl-) Number of samples: Range evaluated (mM): Slope: Intercept: Correlation Coefficient (r): Sy.x: 56 74.8 - 136.4 0.956 4.64 0.986 3.
ACCURACY - CONTINUED Glucose (Glu) Number of samples: Range evaluated (mg/dL): Slope: Intercept: Correlation Coefficient (r): Sy.x: 37 19 -338 0.970 5.47 0.992 11.08 Creatinine (Cr) Number of samples: Range evaluated (mg/dL): Slope: Intercept: Correlation Coefficient (r): Sy.x: 110 0.5 - 10.1 0.940 0.16 0.981 0.55 Lactate (LA) Number of samples: Range evaluated (mmol/L): Slope: Intercept: Correlation Coefficient (r): Sy.x: 117 1.1-11.5 0.959 -0.032 0.98 0.46 D.
PRECISION Precision was performed on commercially available liquid control solutions. Typical precision was observed as follows. pH Level 1 Level 2 Level 3 Day 1 Number of samples: Mean: SD: CV (%): 15 7.228 0.007 0.1 15 7.416 0.005 0.1 15 7.631 0.011 0.2 Day 2 Number of samples: Mean: SD: CV (%): 15 7.228 0.006 0.1 15 7.414 0.005 0.1 15 7.625 0.008 0.1 pCO2 Level 1 Level 2 Level 3 Day 1 Number of samples: Mean (mmHg): SD: CV (%): 15 70.7 2.2 3.1 15 38.5 1.7 4.3 15 17.7 0.7 3.
PRECISION - CONTINUED Na+ Level 1 Level 2 Level 3 Level 4 Day 1 Number of samples: Mean (mM): SD: CV (%): 14 99.5 1.9 1.9 16 120.4 2.9 2.4 15 153.1 1.6 1.1 14 130.8 2.3 1.8 Day 2 Number of samples: Mean (mM): SD: CV (%): 15 100.6 1.9 1.9 14 120.9 1.6 1.4 15 152.3 1.8 1.2 15 131.3 2.1 1.6 K+ Level 1 Level 2 Level 3 Level 4 Day 1 Number of samples: Mean (mM): SD: CV (%): 14 1.76 0.037 2.1 16 3.93 0.080 2.0 15 5.74 0.103 1.8 14 6.03 0.105 1.
PRECISION - CONTINUED Cl- Level 1 Level 2 Level 3 Day 1 Number of samples: Mean (mM): SD: CV (%): 15 30.5 0.72 2.4 15 56.9 0.36 0.6 14 86.6 1.2 1.4 Day 2 Number of samples: Mean (mM): SD: CV (%): 14 30.4 0.65 2.1 15 57.1 0.24 0.4 14 85.8 1.6 1.9 Hct Level 1 Level 2 Level 3 Day 1 Number of samples: Mean (%PCV): SD: CV (%): 14 38.8 1.17 3.0 16 22.7 2.52 11.1 14 46.9 1.16 2.5 Day 2 Number of samples: Mean (%PCV): SD: CV (%): 15 37.8 0.97 2.6 14 22.4 1.57 7.0 15 47.2 1.31 2.
PRECISION - CONTINUED Glu Level 1 Level 2 Level 3 Level 4 Day 1 Number of samples: Mean (mg/dL): SD: CV (%): 11 48.2 3.54 7.3 12 102.7 6.16 6.0 12 200.7 6.90 3.4 12 353.4 18.96 5.4 Day 2 Number of samples: Mean (mg/dL): SD: CV (%): 12 48.6 2.17 4.5 11 105.9 3.01 2.8 12 203.3 7.53 3.7 12 351.7 9.19 2.6 Day 3 Number of samples: Mean (mg/dL): SD: CV (%): 12 47.6 2.54 5.3 12 103.7 2.75 2.7 12 194.5 7.68 3.9 12 351.2 19.75 5.8 Day 4 Number of samples: Mean (mg/dL): SD: CV (%): 12 47.2 2.
PRECISION - CONTINUED Cr Level 1 Level 2 Day 1 Number of samples: Mean (mg/dl): SD: CV (%): 12 1.5 0.09 6.1 11 8.2 0.46 5.6 LA Level 1 Level 2 Level 3 Mean (mmol/L): SD: % CV: 0.7 0.056 7.7 2.5 0.085 3.4 6.7 0.331 4.9 D.
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.
Category Default Setting Test Settings • Product and Parameter Setup • Calculations All products and parameters enabled On (HCO3-, TCO2, BEb, BEecf, O2Sat, tHb and MDRD GFR) Off (iCa(N)) • Patient tHb (for BEb Calc.
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 volume 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.
WARNINGS AND LIMITATIONS OF USE: • Read instructions for the IRMA TruPoint system and capillary device before use. • For in vitro diagnostic use only. • For capillary sample collection and analysis. This device is not sterile and is not intended to be used as a syringe. • 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 dilute the sample.
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 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.
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.
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.
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Appendix H Warranty LIMITED WARRANTY International Technidyne Corporation (“the Company”) warrants the IRMA TruPoint Analyzer, Battery Charger, and 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
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.
