ITC IRMA TruPoint Blood Analysis System User Manual

4 (1)

User Manual

ITC Technical Support: 1-800-631-5945 (Press 2) 1-732-548-5700 (Press 2)

ITC Customer Service: 1-800-631-5945 (U.S.) (Press 1) 1-732-548-5700 (outside U.S.)

This manual is published by International Technidyne Corporation (ITC) for use with the IRMA TruPoint Blood Analysis System Version 7.1 or above.

Questions or comments regarding the contents of this manual can be directed to the address at the bottom of this page or to your ITC representative.

IRMA® and IRMA TruPoint® are registered trademarks of ITC.

© Copyright 2008. This document is the copyright of ITC and must not be copied or reproduced in any form without prior consent. ITC reserves the right to make technical improvements to this equipment and documentation without prior notice as part of a continuous program of product development.

	Rev.5
441116	1010

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Table of Contents

Section Page

1. The IRMA TruPoint® Blood Analysis System	1.1
Introduction	1.1
Intended Use	1.1
System Overview	1.1
CLIA Complexity Classification	1.1
Implementation	1.1
System Components	1.2
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	1.7
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 Analyzer	1.9
System Features and Setup	1.9
Main Menu Access	1.9
Alternate Languages	1.10
IRMA TruPoint Touchscreen Interface	1.10
System Security	1.11
System Setup	1.12
System Features	1.12
Bar Code Reader	1.15
VueLink	1.18
Device Communication Utility (DeviceCom)	1.20
DeviceSet	1.20

Section Page

2. Patient Sample Analysis	2.1
Overview	2.1
Sample Requirements	2.1
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/Lactate Sample Handling	2.3
Preparing the Sample for Injection	2.3
Sample Injection	2.4
Injecting a Syringe Sample	2.4
Injecting a Capillary Sample	2.6
Patient Test Procedure	2.6
Performing a Patient Test	2.6
Test Information Entry	2.13
Entering Test Information	2.13
Test Information Entry – Miscellaneous	2.16
Oxygen Therapy Information Entry	2.16
Entering Oxygen Therapy Information	2.16
Oxygen Therapy Entry – Miscellaneous	2.18
Patient Bypass Status	2.19
Selecting Patient Bypass Status	2.19
Patient Notes	2.19
Entering Patient Notes	2.19
QC Lockout	2.20
Satisfying QC Lockout - General Rules	2.20
QC Lockout Screens	2.20
References	2.21

Section Page

3. Quality Control Testing	3.1
Overview	3.1
IRMA TruPoint Quality Control	3.2
Quality Control Recommendation	3.3
Run an EQC Test:	3.3
Run Two Levels of Liquid Control:	3.3
Additional Liquid Control Testing:	3.3
Run a Temperature Test:	3.3
Electronic Quality Control	3.4
Performing a Manual EQC Test	3.4
Automatic EQC Test	3.6
Liquid Quality Control	3.6
Liquid QC Material Requirements	3.6
Performing a Liquid Control Test	3.7
Initiate Liquid QC Test	3.7
Temperature test	3.13
Performing a Temperature Test	3.13
References	3.14

4. Data Access	4.1
Overview	4.1
Data Storage	4.1
Recalling Results	4.2
Patient Results	4.2
Quality Control Results	4.5
Results Transfer	4.9
Manual Transfer of IRMA TruPoint Results	4.9
Automatic Results Transfer	4.10

iii

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	6.1
Removing the Battery	6.3
Charging the Battery (Routine)	6.3
Conditioning the Battery	6.4
Analyzer Maintenance	6.4
Changing the Printer Paper	6.4
Calibrating the Barometer	6.5
Cleaning System Components	6.5
Cleaning the Touchscreen	6.5
Cleaning the Battery Charger, Power Supply, and
Analyzer Surfaces	6.6
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	7.1
Overview	7.1
Setting Options Menu	7.1
Test Settings	7.2
Product Setup	7.2
Lot Entry	7.3
Calculations	7.4
Test Information	7.6

Section	Page
Correlation	7.8
Bypass Correlation	7.11
Display Units	7.12
Reference Ranges	7.12
Reportable Ranges	7.14
Quality Control (QC) Settings	7.15
QC Lockout	7.15
Controls	7.17
User ID Settings	7.19
Default QA User ID	7.20
Adding a New QA User ID	7.20
User ID Options	7.21
Device Settings	7.22
Beeper	7.22
Calibrate Barometer	7.22
Communications	7.23
Date Format	7.27
Date/Time	7.27
Auto Print	7.28
Screen Contrast	7.28
VueLink	7.28

8. Appendixes

A: Limitations and Safety Precautions	A.1
B: System Specifications and Cartridge Information	B.1
C: Principles of Operation	C.1
D: Performance Characteristics	D.1
E: Default Settings	E.1
F: IRMA TruPoint Capillary Collection Device	F.1
G: Software Updates	G.1
H: Warranty	H.1

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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 OVERVIEW

The major components of the IRMA TruPoint system are a portable, batteryoperated 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

SYSTEM - MAJOR COMPONENTS

Figure 1-1

A.IRMA TruPoint analyzer

B.Battery charger (PN 442900) and power supply (PN 573400)

C.Two rechargeable batteries (PN 448700)

D.Temperature card

E.User manual

F.Two rolls of thermal printer paper (PN 403800)

G.AC Adapter (PN 440100)-Not Pictured

IRMA TruPoint cartridges (not pictured) are ordered, packaged, and shipped under separate cover.

Additional system components are available for use with the IRMA TruPoint system, including the Integrated Data Management System (idms), the SureStepPro Glucose Module (PN 444100), an AC power adapter (PN 440100), and a bar code reader (PN 463120). Contact your service provider for information on these and other IRMA TruPoint products.

1.2

IRMA TRUPOINT BLOOD ANALYZER

Figure 1-2

A.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 onboard storage of the Temperature Card.

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.

1.5

ITC IRMA TruPoint Blood Analysis System User Manual

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.

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 (54-86°F). If the analyzer is exposed to a temperature outside of that range for a significant period of time, an instrument temperature error message may display. The analyzer must equilibrate at a temperature within the temperature operating range for a minimum of 30 minutes before testing may resume.

ASSEMBLE THE CHARGER

•Connect the power supply to the IRMA TruPoint charger.

•Connect the wall cord to the power supply.

•Plug the wall cord into an electrical wall outlet (110 VAC/60Hz or 220 VAC/50 Hz).

CHARGE THE BATTERY

Conditioning Charge:

Prior to initial use, condition each battery as follows:

•Insert a battery into the battery charger. The battery should ‘click’ into the charger when properly inserted. The yellow light indicates that the battery is charging. Charge the battery for 24 hours.

•After 24 hours, remove the battery from the charger, then reinsert the battery into the charger. Leave the battery in the charger until the green light flashes continuously, indicating that the battery is fully charged. The battery should remain in the charger until it is needed for use in the analyzer.

Routine Charge:

See Section 6-Charging the Battery - Routine for routine battery charging instructions.

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 TruPoint cartridges that require storage at room temperature (15- 30°C/59-86°F), must be removed from their shipping container and equilibrated to room temperature prior to use. Equilibration times depend on the product type. Refer to Appendix B, Table B-7 for equilibration times.

Equilibrate cartridges as follows:

•Remove cartridges from their shipping container upon receipt.

•Place cartridges in the area where they will be stored. The storage area must have a stable temperature between 15-30°C (59-86°F). The cartridge storage temperature must not fluctuate more than 8°C (14.4°F). If it does, the cartridges must go through an additional equilibration period before they can be used.

•Proper storage conditions should be 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 15 minutes.

•CR cartridges must be used within 8 hours of removal from the refrigerator.

•CR Cartridges that are not used within 8 hours should be discarded. Do not place unused cartridges back into the refrigerator.

1.8

CARTRIDGE TEMPERATURE OPERATING RANGE

The IRMA TruPoint temperature operating range is 12-30°C (54-86°F).

•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 SETUP

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.

1.9

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.

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 onscreen display. IRMA TruPoint uses the following conventions and screen icons:

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

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

Completes the current procedure and returns to the appropriate menu.

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

Proceeds to the next step in the procedure.

Test Information Button displays on screens where patient test information can be added to test result record, and initiates patient test information entry.

Oxygen Therapy Button displays on screens where patient oxygen therapy information can be added to test result record, and initiates patient oxygen therapy information entry.

1.10

Bypass Status Button displays on the Calibrating and Analyzing screens when available. When “On Bypass” option is selected, Bypass Correlation hematocrit results are reported.

Temperature Test Button displays on the QC TEST OPTIONS screen, and initiates an IRMA TruPoint temperature test.

QC Lockout Icon may be displayed on the 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 6- Battery 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 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 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 Cardiopulmonary 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

•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.

•QC Lockout: Allows optional definition of requirements (number of tests per level per shift) for both electronic and liquid QC that must be met before the analyzer can be used for patient testing.

•Reference Ranges: Allows ability to define reference ranges and provide an optional entry of an upper and lower reference limit for each analyte by sample type, and a reference range title. When activated, patient test results that fall outside of the defined limits will be flagged “H” (High) or “L” (Low). The ranges are reported on the analyzer printout with each associated test and sample type. Reference ranges are stored with the results at the time the test is performed; therefore, changes can be made to the limits without affecting previous results.

•Reportable Ranges: Allows optional entry of user-defined upper and lower reportable range limits for each analyte. User-defined reportable range limits must be within the default IRMA TruPoint reportable range limits.

•Results Transfer: Enables transfer of new or previously-transferred results via the serial port, LAN 10/100 port, or the internal or external modem utilizing ASTM standard format and communication protocols.

•Sample Type/Site: Allows optional selection of a sample type and site (from pre-defined list) to be associated with a patient test record.

•Screen Contrast: Allows touchscreen backlight to be adjusted to one of nine settings for optimal viewing in all ambient light conditions.

•Sleep Mode: When the analyzer is “on” and has not been used for two minutes, the analyzer goes into a 2 minute sleep mode (screen goes dark) to conserve battery power. The user can return to the last screen displayed by touching the right side of the screen at anytime during sleep mode. When powered by battery, the analyzer powers down if the 2 minute sleep mode period passes without any activity. When powered by AC adapter, the analyzer will not shut down after 2 minutes of inactivity in sleep mode. Entry of a User ID is required (if the User ID feature is enabled) to exit sleep mode. During the two minute sleep mode, the beeper (if enabled) will beep every 15 seconds, unless the screen is on the main MENU or Enter ID screens.

1.14

•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. The bar code reader is connected to the round accessory port located on the back of the IRMA TruPoint analyzer, next to the RJ45 serial port.

Intended Use

The bar code reader can be used to scan the following information:

•Cartridge information: Cartridge type, lot code, and cal code are all encoded in a single bar code found on the cartridge package label. The cartridge package may be scanned with each test instead of manually selecting Product Type and verifying the information on the Verify Information screen.

•Glucose test strip information: Lot code and Ctl code are encoded in separate bar codes found on the SureStepPro test strip bottle. The bottle label may be scanned with each test instead of manually selecting Product Type and verifying the information on the Verify Information screen.

•User IDs: User ID bar codes may be scanned, replacing manual entry of IDs via the touchscreen keyboard.

•Patient IDs: Patient ID bar codes may be scanned, replacing manual entry of IDs via the touchscreen keyboard.

•QC Expected Values: Expected values for Liquid Quality Control and Calibration Verification Control materials can be scanned from the expected values chart, replacing the manual entry of values via the touchscreen keyboard.

During power-up, the IRMA TruPoint analyzer determines whether or not a bar code reader is connected to the analyzer, and will display the appropriate screen prompts. The bar code reader will only be activated on the entry screens for cartridge information, User ID, Patient ID and QC control settings.

1.15

Bar Code Scan Symbologies

The bar code reader is factory programmed to read the following bar code symbologies:

Code 11	EAN/JAN	Plessey
Code 39	Interleaved 2 of 5	Telepen
Code 128	Matrix 2 of 5	UPC
Codabar	MSI

Scanner Specifications

Refer to the User’s Guide that came with the bar code reader for detailed specifications and regulatory compliance statements.

Note:

• The Welch Allyn bar code reader uses a non-laser, red LED light source.

Connecting the Bar Code Reader

1.Ensure that the IRMA TruPoint analyzer is turned “off”.

2.Connect the bar code reader cable to the round keyboard port on the back of the analyzer.

3.The reader will be ready for use when the analyzer is powered back “on”.

Caution:

•The IRMA TruPoint analyzer can only determine the presence or absence of a bar code reader during analyzer power-up. Do not connect or disconnect the reader when the analyzer is “on”. Doing so may result in damage to the reader or analyzer, or the display of incorrect screen prompts.

Disconnecting the Bar Code Reader

1.Ensure that the IRMA TruPoint analyzer is turned “off”.

2.Disconnect the bar code reader cable from the keyboard port on the back of the analyzer.

Mounting the Bar Code Reader

The bar code reader may be attached to the IRMA TruPoint analyzer using the mounting clip that came with the reader.

Figure 1-6

1.Attach the clip to the IRMA TruPoint handle as shown. (Figure 1-6).

1.16

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. (Figure 1-8)

Figure 1-8

button

Operating the Bar Code Reader-Patient Sample Analysis and QC Testing

If a bar code reader is connected to the IRMA TruPoint analyzer, the appropriate screen prompts will display upon initiation of a patient test or liquid QC test. The bar code scanner can be used to scan the following items:

•User ID

•Patient ID

•Cartridge Information: Product Type, Lot Code, and Cal Code are encoded in the single bar code found on each cartridge package label.

•Glucose Test Strip Information: Product Type, Strip Lot, and Ctl Code are encoded in the two bar codes found on each test strip bottle label.

•QC and Calibration Controls: QC product, level, lot number, expiration date, and expected values are encoded in the series of bar codes located on the ITC expected values sheet. These sheets are located at www.itcmed.com.

1.17

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. Scan the cartridge package label for the cartridge to be used. Note: To manually enter and/or verify cartridge information, press manual entry.

a.Successful scan - cartridge product type, Lot Code, and Cal Code will be accepted. The IRMA TruPoint display will automatically advance to the next screen (the Select Product Type and Verify Information screens will not be displayed).

b. Scanning Error - the Scanning Error message will be displayed. The cartridge bar code may be re-scanned, or the user may press manual entry to manually enter and/or verify product type, Lot Code, and Cal Code.

VUELINK

Please contact your local representative regarding the current availability of Vuelink.

Description

The Philips/Agilent VueLink module is a component for Philips/Agilent patient monitors. VueLink allows IRMA TruPoint patient test results to be transmitted to the Philips/Agilent patient monitor for display.

VueLink Setup

Refer to Section 7-VueLink for IRMA TruPoint VueLink setup instructions.

Patient ID should be configured “Required”.

Refer to the appropriate Philips/Agilent document for monitor operating instructions and other information related to the Philips/Agilent patient monitoring system and VueLink.

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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.The Sending to VueLink screen displays once a connection has been established. The user has 15 seconds to verify that the patient ID from the test record transmitted matches the patient ID entered into the patient monitor.

a. Patient ID verified within allotted time - test results display on the patient monitor and the IRMA TruPoint advances to the appropriate screen, depending on setup.

b. Patient ID not verified within allotted time - test results do not display on the patient monitor and the IRMA TruPoint advances to the appropriate screen, depending on setup.

Transmission Errors

If a connection is made, but the transmission is unsuccessful, an error message will display.

a.Resend - verify connections and receiving system and press resend button.

b.Cancel transmission - press cancel button.

Transmitting Recalled Results

All IRMA TruPoint patient test results can be recalled and transmitted to VueLink.

•A result can be transmitted multiple times.

•A result cannot be edited in IRMA TruPoint once it has been transmitted to VueLink.

•Transmitting a result to VueLink does not affect its sent/unsent status for transmission to idms or a host system.

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DEVICE COMMUNICATION UTILITY (DEVICECOM)

Description

DeviceCom is a PC software application that handles all communications between the IRMA TruPoint device and other software programs such as idms.

DeviceCom Setup

There is no specific DeviceCom setup required in IRMA TruPoint. See the

Device Communication Utility User Manual for DeviceCom setup instructions.

DEVICESET

Description

DeviceSet is a PC software tool that provides an easy and efficient way to create, modify, restore and manage configuration settings on all IRMA TruPoint instruments at a site. Settings profiles are established in DeviceSet and then a profile is assigned to one or more IRMA TruPoint analyzers. A profile is a collection of IRMA TruPoint settings that includes most of the IRMA TruPoint settings that may be manually established via the IRMA TruPoint SETTINGS OPTIONS menu.

QA Users can configure IRMA TruPoint to automatically receive settings profile updates, or updates may be sent manually.

•Automatic Device Updates: available settings profile updates, as well as available software and/or language updates are automatically transferred to IRMA TruPoint when downloading test results to idms. Following IRMA TruPoint software upgrades, DeviceSet automatically restores settings in the IRMA TruPoint that would otherwise revert to factory default settings.

•Manual Device Updates: QA Users can manually request updates from DeviceSet via the IRMA TruPoint SETTING OPTIONS menu.

DeviceSet Setup

Refer to Section 7-DeviceSet for automatic update setup instructions. Refer to the DeviceSet User Manual for DeviceSet instructions.

Initiating a Manual Device Update

QA Users may initiate a manual device update as follows:

1.Upload any unsent results to idms or a host system.

2.Press the DeviceSet button on the SETTING OPTIONS menu.

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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. If new software or language updates are available, they will be also be sent.

b.“receive new” - Only profile settings that have changed since the last analyzer update will be sent to the analyzer. If new software or language updates are available, they will be also be sent.

5.The available updates (i.e., Languages, Software, Settings, None), and the estimated time it will take to complete the update will display. If there is a profile associated with the analyzer and there are

no unsent records in the analyzer, pressing ok will continue the update until completion.

If the update cannot proceed for one of the following reasons, a message screen will be displayed:

a.The analyzer is not associated with a profile.

>Press ok to continue update. Factory default IRMA TruPoint settings will overwrite existing analyzer settings. If new software or language updates are available, they will be also be sent.

>Press cancel to cancel update and return to the SETTING OPTIONS menu.

b.Result Transfer setting is “idms” and there are unsent results.

>Unsent results will automatically be transferred when ok is pressed from the Updates Available screen.

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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.

6.When the update is complete, THE SETTING OPTIONS menu will display.

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