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 a bove.
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
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
®
Blood Analysis System 1.1
i
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
ii
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 Opera ting 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
iv
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
v
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vi
Section 1
The IRMA TruPoint®
Blood Analysis System
INTRODUCTION
This section outlines general information about the IRMA TruPoint Blood
Analysis System, and descri bes th e installati on 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 t he IR MA T ruPoint 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 classific ation (s ee 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
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
Figure 1-1
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: guid es user thro ugh all asp ects 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 Are a (underneath): provides on-
board 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 batter y charger and p ower supply.
• NiMH batteries take approximately 5.5 hours (battery empty wh en p laced
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 oper ated on A C 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
IRMA TRUPOINT CARTRIDGES
Each IRMA TruPoint cartridge contains a sensor array and self-contained
calibrant. One patient or liq uid QC test is perform ed on each ca rtridge.
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
• Ver ify 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 mu st be returned in the original packaging mate rials. 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 Ch arge:
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 batter y 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 ca rt ridges are shippe d in an insulated s hipping 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 (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 c artridges in the area where they will be stored. The stor age 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 shou ld 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
• Inser t a charged battery or AC Adap ter 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
or the
Menu button from othe r scr eens .
done button
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
the language selected.
next. The main MENU displays in
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 entrie s 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 cu rrent procedur e and returns to th e appropriate
menu.
Allows a displayed or highlighted screen item or setting to be
changed.
Proceeds to the ne xt step in t he pr oce dure.
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 hem atocrit 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. Produ ct 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 auto matically 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 p rinter, and setting
the time, date format, and screen contrast.
1.11
Note:
• The Gluc Strip User privilege is available for users th at 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 nonNIST-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 en try 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 b ar 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 en try o f slope and interc ept va lues fo r 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 diagnost ic 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 automatic ally when the analyzer is powered by the
AC adapter.
• Oxygen Therapy Information: A llows 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 no tes
to be associated with a patient test record.
1.13
• QC Notes: Allows optional en try 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 b e ma d e 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 Ty pe/Site: Allows optional selection of a sample type and site
(from pre-defined list) to be associated with a patient test record.
• Screen Contras t: Allows touchscreen backlight to be adjusted to one o f
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 ena bled) 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, replaci ng ma nual ent ry
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 no t a
bar code reader is connected to the analyz er, 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 c omplianc e stat em ents.
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 th e 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 b e attached to the IRMA TruPoint anal yzer using
the mounting clip that came wit h the reader.
Figure 1-6
1. Attach the clip to the IRMA
TruPoint handle as shown.
(Figure 1-6).
1.16
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 1-7
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 co de will display at
the appropriate time. Scan the cartridge
package label for the cartridge to be used.
Note: To manually enter an d/or ve rify
cartridge information, press
a. Successful scan - cartridge product type, Lot Code, and Cal Code will
be accepted. The IRM A TruP oint display will a utoma tically a dvan ce
to the next scr een (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.
manual entry.
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 instructi ons .
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.
1.18
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
and advance IRMA TruPoint to the appropriate screen.
2. The Sending to VueLink sc reen 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.
done will end the test
a. Patient ID verified wi thin allot ted 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 p atie nt m oni tor an d t he IR MA Tru Poi nt a dva nces to t he
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
b. Cancel transmission - press
button.
resend button.
cancel
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.
1.19
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 wa y 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
OPTIONS menu.
DeviceSet button on the SETTING
1.20
3. a. If the Communications Method setting is
User Selects, highlight the button next to
the appropriate method and press
go to step 4.
b. If the Communications Method setting is
not User Selects, go to step 4.
4. Connect cable to computer and veri fy 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.
next and
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 updat e
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.
1.21
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
MENU.
d. Result Transfer setting is “off” and there are un sent resul ts.
> The unsent stored re sults may be delete d
during the software update. Press
continue update if stored results have
already been retrieved or if it is acceptable
that they may be deleted.
ok to return to the main
ok to
> Press
cancel to cancel update and retrieve re sults.
6. When the update is complete, THE SETTING OPTIONS menu will
display.
1.22
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