IRMA TRUPOINT User Manual Rev 2

Table of Contents Section

Page

1. The IRMA TRUpoint™ Blood Analysis System Introduction Intended Use

1.1

System Overview

1.1

CLIA Complexity Classification

1.1

Implementation

1.1

System Components IRMA TRUpoint Blood Analysis System - Major Components 1.2 IRMA TRUpoint Blood Analyzer

1.3

IRMA TRUpoint Battery Charger and Power Supply

1.4

IRMA TRUpoint AC Power Adapter

1.5

IRMA TRUpoint Cartridges

1.6

Getting Started Unpack and Inspect the System

1.7

Bring the Analyzer to Room Temperature

1.7

Assemble the Charger

1.7

Charge the Battery

1.7

Unpack the IRMA TRUpoint Cartridges

1.8

Cartridge Storage and Equilibration Procedure

1.8

Cartridge Temperature Operating Range

1.9

Insert Charged Battery or AC Adapter into IRMA TRUpoint Analyzer

1.9

System Features and Set Up Main Menu Access

1.9

Alternate Languages

1.10

IRMA TRUpoint Touch Screen Interface

1.10

i

Section

Page

System Security

1.11

System Setup

1.12

System Features

1.12

Bar Code Reader

1.15

VueLink

1.18

Device Communication Utility (DeviceCom)

1.19

DeviceSet

1.20

2. Patient Sample Analysis 2.1

Overview Sample Requirements Acceptable Specimens

2.1

Syringe Requirements

2.1

Capillary Requirements

2.2

Sample Size

2.2

General Sample Collection Guidelines

2.2

Blood Gas Sample Handling

2.2

Electrolyte/Glucose Sample Handling

2.3

Preparing the Sample for Injection

2.3

Sample Injection Injecting a Syringe Sample

2.4

Injecting a Capillary Sample

2.6

Patient Test Procedure 2.6

Performing a Patient Test Test Information Entry Entering Test Information

2.13

Test Information Entry - Miscellaneous

2.15

Oxygen Therapy Information Entry Entering Oxygen Therapy Information

2.16

Oxygen Therapy Entry - Miscellaneous

2.18

ii

Section

Page

Patient Bypass Status Selecting Patient Bypass Status

2.18

Patient Notes 2.19

Entering Patient Notes QC Lockout Satisfying QC Lockout - General Rules

2.19

QC Lockout Screens

2.20

3. Quality Control Testing Overview

3.1

IRMA TRUpoint Quality Control

3.2

Quality Control Recommendation Run an EQC Test

3.3

Run Two Levels of Liguid Control

3.3

Additional Liquid Control Testing

3.3

Run a Temperature Test

3.3

Electronic Quality Control Performing a Manual EQC Test

3.4

Automatic EQC Test

3.6

Liquid Quality Control Liquid QC Material Requirements

3.6

Performing an Liquid Control Test

3.7

Initaiate Liquid QC Test

3.7

Temperature Test Performing a Temperature Test References

iii

3.13

Section

Page

4. Data Access Overview

4.1

Data Storage

4.1

Recalling Results Patient Results

4.2

Quality Control Results

4.5

Results Transfer Manual Transfer of IRMA TRUpoint Results

4.9

Automatic Results Transfer

4.10

5. Troubleshooting Overview

5.1

Troubleshooting General Operating Problems

5.2

Troubleshooting Specific Operating Problems

5.4

6. Maintenance 6.1

Overview Battery Maintenance General Instructions

6.1

Removing the Battery

6.3

Charging the Battery (Routine)

6.3

Conditioning the Battery

6.4

Analyzer Maintenance Changing the Printer Paper

6.4

Calibrating the Barometer

6.5

Cleaning System Components Cleaning the Touchscreen

6.5

Cleaning the Battery Charger, Power Supply and Analyzer Surfaces

6.6

iv

Section

Page

Cleaning the Battery Contacts

6.6

Cleaning the Infrared Probe

6.6

Cleaning the Edge Connector

6.7

Cleaning the Temperature Card

6.7

Replacing the Edge Connector

6.8

7. System Settings Overview

7.1

Setting Options Menu

7.1

Test Settings Product Setup

7.2

Lot Entry

7.3

Calculations

7.4

Test Information

7.6

Correlation

7.8

Bypass Correlation

7.11

Display Units

7.12

Reference Ranges

7.12

Reportable Ranges

7.13

Quality Control (QC) Settings QC Lockout

7.14

Controls

7.16

User ID Settings Default QA User ID

7.19

Adding a New QA User ID

7.19

User ID Options

7.19

Device Settings Beeper

7.21

Calibrate Barometer

7.21

Communications

7.22 v

Section

Page

Date Format

7.26

Date/Time

7.26

Auto Print

7.27

Screen Contrast

7.27

VueLink

7.27

Appendixes Appendix A: Limitations and Safety Precautions

A.1

Appendix B: System Specifications and Cartridge Information

B.1

Appendix C: Principles of Operation

C.1

Appendix D: Performance Characteristics

D.1

Appendix E: Default Settings

E.1

Appendix F: IRMA TRUpoint Capillary Collection Device

F.1

Appendix G: Software Updates

G.1

Appendix H: Warranty

H.1

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-5 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 testing 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. 1.1

SYSTEM COMPONENTS IRMA TRUpoint BLOOD ANALYSIS 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) F. 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 440100), and a bar code reader (PN 463120). Contact your service provider for information on these and other IRMA TRUpoint products. 1.2

IRMA BLOOD TRUpoint 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. This removable connector protects the analyzer from internal damage by spilled liquids or other contaminants. F. 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.

A B

C

F

G

E

D

1.3

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. 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. • 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. • If the user ID feature is enabled, then the user ID screen will be displayed before the analyzer can be accessed again. • The analyzer power can be left on indefinitely • 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.

Caution: AC Power Adapter is not intended for use within a 1.5 meter radius of patient. 1.5

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. 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. I. Air Vent: located on the bottom, left side of the waste reservoir. J. Cal Cap: contains calibrant for cartridges with enzymatic sensors.

A B

J

C D E F G H I

H4 Cartridge

CC 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 materials 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 (5486°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. 1.7

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 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 TRUpount cartridges that require storage at room temperature (1530°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 documented 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 30 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). • 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. • Refrigerated cartridges may be used until their out-of-refrigerator outdate.

INSERT CHARGED BATTERY OR AC ADAPTER INTO IRMA TRUpoint ANALYZER • 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 SET UP 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 or the Menu button from other screens.

... Enter or Scan ID abc abc

cancel

1

2

3

4

5

6

7

8

9

0

ui14n

MENU QC Test

quit

Recall

Settings

1.9

next

patient test

Main Menu

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. The Select Language screen displays a picklist containing all available analyzer languages. Highlight the desired language and press next. The main MENU displays in the language selected.

Btldr rev: v1.0.3 App rev: v6.1.0

Logo

Select Language

English French German Spanish

cancel

next

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: back

Does not save entries on the current screen and returns to the previous screen.

cancel

Returns to the beginning of the procedure and does not save entries made throughout the procedure.

done

Completes the current procedure and returns to the appropriate menu.

edit

Allows a displayed or highlighted screen item or setting to be changed.

next

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.

O2

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 Select 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. 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 6Battery Maintenance for details.

• 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 date, 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 options. These setting options include enabling or disabling the beeper and printer, and setting the date, time, date format, and screen contrast.

1.11

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. • 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. • 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. • 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: • 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 the IRMA TRUpoint barometer reading is not recommended. • Enter appropriate User IDs if the User ID feature is enabled. • 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.

1.12

• 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 Cardiopulmonar y Bypass (Pump) Hematocrits: Allows optional entry of hematocrit slope and intercept values specifically for samples from patients on cardiopulmonary bypass 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