IRMA TRUpoint

IRMA TRUpoint
Training Guide
We appreciate your decision to make IRMA TRUpoint your
choice for critical patient management. The following
training guide is provided to assist with training personnel on
the analyzer. The operators manual and package inserts
should be read prior to use.

Main Menu
• Pre-training Checklist
• Overview
• Getting Started
• System Settings
• Performing a Patient and QC test
• Maintenance
• Troubleshooting
• General Information

Checklist
• Prior to initial setup and training, please make sure
the following has been completed:
Task # Task Completed
1 Recommended Liquid Quality
Controls have been received and
equilibrated.
2 Cartridges unpacked and
equilibrated.
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3 Unpack IRMA TRUpoint and
verify all components are present.
4 If analyzer is to be used with
battery pack, charge for 24 hours.
5 Printer paper has been installed
in analyzer.
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Obtaining Liquid QC Material
• Liquid quality controls are used to verify
analyzer and cartridge performance and
are available from your supplier.
• LQC kit number required is based on
cartridge type being run.
• Updated assay sheets are available at
www.itcmed.com.

IRMA TRUpoint Overview

IRMA TRUpoint
• IRMA TRUpoint is a self-contained,
portable analyzer that measures blood
gases, hematocrit, electrolytes, and other
time critical parameters in-clinic or in the
field.

Intended Use
• The IRMA TRUpoint is intended
for use with IRMA TRUpoint
cartridges for the in vitro
measurement of various critical
care measurements in whole
blood.
• The IRMA TRUpoint is classified
as “moderately complex” under
CLIA test categorizations.
(Human only)

IRMA TRUpoint
Cartridge Technology
• An important feature of the IRMA TRUpoint is the single-use
cartridge. Each cartridge contains miniaturized
electrochemical measurement sensors and on-board
calibrant.

IRMA TRUpoint Cartridges
• Analytes are configured on a variety of cartridges.
Cartridge Name Cartridge Description
BG Cartridge
Combo
Cartridge
H3 Cartridge
H4 Cartridge
Blood Gas cartridge
Blood Gas and Electrolyte cartridge
HCT and Electrolyte Testing
HCT, Electrolyte Testing, and BUN
CR Cartridge
GL Cartridge
LA Cartridge
Creatinine cartridge
Glucose and Electrolyte cartridge
Lactate cartridge

Test Menu
• The IRMA TRUpoint test
menu consists of analytes
which are available in a
variety of panel
configurations.

IRMA TRUpoint System
• IRMA TRUpoint Blood Analysis System
includes the:
– Instrument
• With Ethernet LAN Port
• Serial port
– AC Adapter
– Battery Charger
– Two (2) NiMH Batteries
– Temperature Card
– Operators Manual
– Optional accessories:
• Bar Code Scanner

System Features
Onboard Thermal Printer
• Provides hard copy of test
results and information
Interactive Touch Screen
• Guides the user through all aspects of operation.
• The analyzer is powered-on by touching the righthand
edge of the screen.
• Information is entered, and analyzer options
selected, by pressing the touch sensitive keys
displayed on the screen.

System Features
Bar Code Reader (Optional):
Is a high performance linear imaging
bar code reader that can be used to
scan cartridge and glucose strip
information, user ID’s, patient ids, and
control values.
Edge Connector Block:
•Electronically connects the
cartridge to the analyzer.
•This is removable
connector protects the
analyzer from damage by
spilled liquids or other
contaminants.

System Features
Rechargeable Battery and Charger
• Provides portability
• Charger will discharge battery prior to recharging
to prevent battery memory problems
Temperature Card:
Used to perform a
temperature test

System Features
• Edge Connector
– Prevents contamination of
analyzer interior
– Can be easily replaced by
user without tools
• IR probe measures sample
temperature
– All blood gases performed
at 37° C
– Sample heated through
the edge connector via a
heater circuit on the
cartridge lead

TRUpoint Cartridge Features
• Cartridges are packaged in an air tight foil pouch.
• Discard the cartridge if the package appears to be damaged (e.g., a hole
is visible in the package).
Product Code
Lot Number
Calibration Code
Expiration Date
Bar Code

Getting Started and System
Settings

Analyzer Set Up
• Unpack the IRMA TRUpoint
• Bring analyzer to room temperature
– Operating range is 12-30°C (54-86°F)
– If analyzer is exposed to a temperature
outside of the range for a significant period of
time, an instrument error message may
display.
– The analyzer must equilibrate at a
temperature within the operating temperature
range for a minimum of 30 minutes before
testing may resume.

Battery Set-up
The IRMA TRUpoint analyzer can be operated on battery or AC power. The
battery power system consists of two rechargeable nickel metal hydride (NiMH)
batteries.
• Assemble Battery Charger:
– Connect power supply to the IRMA TRUpoint
charger
– Connect wall cord to the power supply
– Plug wall cord into an electrical wall outlet.
• Charging the Battery:
– Insert battery into charger, The yellow light
indicates that the battery is charging.
– The green light indicates the battery is
charged.
– Do not remove until the green light flashes.
• Charging Duration and Yield:
– 5.5 – 10 hours
– Approximately 30-40 tests when fully
charged.

Using the AC Adapter
• The Analyzer can be operated on 110 V AC power using the power
adapter.
• The power supply and battery shell are permanently connected via
the adapter cord.
• The battery shell fits into the IRMA TRUpoint battery
compartment.
• The power cord connects the power supply to the electrical wall
outlet.

Cartridge Equilibration
• Remove cartridges from shipping container and store as follows prior to use:
Cartridge(s)
Equilibration
Time
Storage
Temperature
Warm up
Time
BG, CC 72 hours 15-30°C (59-86°F) None
H3, H4, GL,
LA
1 hour 15-30°C (59-86°F) None
CR None 2-8°C (35.6-46.4°F) 15 min
• If storage range fluctuates more than 8°C (14.4°F), cartridges must go through
an additional equilibration prior to use.
• Cartridges can be used in temperatures down to 12°C, 54°F if used within 4 hours
of transfer from the 15-30°C storage.

System Settings

System Settings
• This section provides information on the
system settings available on the IRMA
TRUpoint.
• Prior to entering the IRMA TRUpoint into use,
system settings should be established as
required by the facility.
• The IRMA TRUpoint has three separate user
levels that will have some or limited access
to modifying these settings.

User ID
• Up to 600 users can be entered.
• Security level can be
established for each.
• Press User ID from the settings
menu.
• Highlight “add users” from the
picklist.
• Enter user ID (Alphanumeric).
• Set user privileges.

System Security
The IRMA TRUpoint analyzer offers 3 user security levels:
1. QA User(s):
– Have access to all IRMA TRUpoint test, recall, and setting options.
– Sole access to barometer calibration, communications configuration,
results transfer, VueLink, and setup of QC Lockout, User ID, and QC.
2. General Users:
– Have access to all IRMA TRUpoint test and recall options, and limited
setting options.
– Setting include enabling or disabling the beeper and printer, and setting
the date, time, date format, and screen contrast.
3. Glucose Module only: Not Applicable.

Product Setup
• Use:
– Product setup can be used to define cartridge types used in the
facility or define which analytes are reported on a cartridge.
• To establish:
– Go to Settings menu, press “test”.
– Highlight product setup and press “edit”.
– Highlight all product types to be used.
– Press “next” to define which analytes are to be reported
– Highlight analytes and press “next”.

Input Lot and Calibration Codes
• Access Test Settings.
• Highlight “Lot entry”.
• Press “edit”.
• Select product type (CC,BG,H4, etc.)
• Highlight “new”, press “edit”.
• Enter cartridge lot number and press
“next”.
• Enter Cal code (front of pouch) and
press “next”.
• Press “Done”.

Uploading QC Values
1. Obtain the IRMA-specific assay sheets
from the ITC website.
2. Access the Settings Options menu.
3. Press “QC”, press “controls”, “select”,
“product type”, press “next”.
4. Press “add” to setup new control.
5. Select control level (1,2,3) and press
“next”.
6. Enter control lot number and press “next”.
7. Enter control expiration date and press
“next”.
8. Select analytes to be measured when
running control and press “next”.
9. Enter or barcode scan in the control limits.
10. Uploading of control values will allow
automatic flagging of any QC results that
test out of range.

Defining Calculated Values
QA Users can define the calculated values to be
reported with each test and the formulas used to
derive the calculated values using the Calculations
option:
1. Go to Menu → Settings → Test → Calculations
2. Highlight Calculations and press edit.
3. Highlight Calculated Values from the picklist and
press edit.
4. Highlight the calculated values to be reported
(depending on product type) with each patient test,
and press next.
5. Follow prompts and select settings.
**See next slide for notes regarding normalized Ca++.

Setting Normalized Calcium - iCa(N)
• iCa++ results can be altered by pH.
• Normalizing adjusts iCa++ results for changes in pH.
Most reference labs report iCa(N).
• Air bubble in sample or exposure to room air ↑ pH
and decreases iCa++.
• Delay in processing sample (> 10 min) ↓ pH and
increases iCa++.
• After setting, IRMA will report both iCa++ and iCa(N).
• When acid-base status is unknown, care should be
taken when interpreting iCa(N).

Establishing Test Information
• QA Users can define the Test Information items that
can be entered with each test.
Test Information includes:
• oxygen therapy, patient ID, patient temperature,
patient hemoglobin, sample type, sample site,
patient notes, and QC notes. Each Test Information
item may be turned “on” or “off”.
1. Highlight Test Information from TEST SETTINGS
and press edit.
2. Highlight the test information option of choice from
the picklist and press edit.
3. Select from the setup choices displayed on the
screen.

Correlation Setting (Optional)
• QA Users can establish correlation parameters for each IRMA
TRUpoint product type to adjust IRMA TRUpoint patient test
results to values that would be expected if samples were run on
another reference analyzer.
There are 2 correlation options:
• Off: Correlation parameters will not be used by the analyzer to
adjust IRMA TRUpoint patient test results.
• On: Correlation parameters will be used by the analyzer to adjust
IRMA TRUpoint patient test results.

Activating Correlations
1. Highlight Correlation from TEST
SETTINGS and press edit. An Attention
message appears, stating that adjusting
correlation factors will affect future patient
test results.
Press ok.
2. Highlight the desired Product Type and
press edit.
3. Highlight ”on” or ”off” button and press
next.
If ”on” is selected, go to “Establishing or
Changing Correlation Factors”.

Establishing or Changing
Correlation Factors (Optional)
1. Insure that Correlation is “on”. Press next from
Correlation screen.
2. Correlation for each analyte can be configured
independently from the Select Analyte screen.
3. Highlight the first analyte in the picklist for which
correlation factors are to be entered.
4. The default settings for slope and intercepts for the
highlighted analyte will appear below the picklist.
5. Press edit to enter the slope and/or intercept value for
the highlighted analyte.
6. Enter slope value and press next.
7. Enter intercept value and press next to return to the
Select Analyte screen. (see manual Appendix B, table B-
10.
8. Repeat for each analyte to be correlated. Press done
when finished.

Display Units
Display units:
• QA Users can designate the units of measure
for barometric pressure, temperature, and
analyte concentration using the Display Units
option.
Defining units of measure:
1. Highlight Display Units from “Test Settings”
and press edit.
2. Highlight the test parameter of choice from
the picklist and press edit.
3. Select the desired unit of measure and press
next.
4. If multiple parameters were selected, select
desired units for each parameter, pressing
next from each screen until complete.

Establishing Reference Ranges
• QA Users can establish a reference range consisting of an upper and
lower limit for each analyte, patient type, and sample origin.
• An out-of-range patient test result will be flagged “H” (High) or “L”
(Low) on the printout and the result will flash on the Results screen.
Setting up patient specific reference ranges:
1. Highlight Reference Ranges from the TEST SETTINGS menu. Press edit.
2. Highlight ”on” button. Press next.
3. If desired, keep default name for reference range or change by deleting and
using alphanumeric keypad to name new patient type.
4. Select desired analyte from the picklist. If reference ranges will be entered for
multiple analytes, select “All”. Press edit.
5. Enter the lower reference limit and press next.
6. Enter the upper reference limit and press next.
7. Continue for all appropriate analytes.
8. Repeat for each new patient and sample type,
i.e. arterial, venous.

Establishing Species-Specific Ranges
• IRMA TRUpoint can store normal ranges for multiple species and
sample types. An out of range patient test will be flagged “H” (High) or
“L” (Low) on the printout and the result will flash on the Results
screen.
Setting up Species Specific Reference Ranges:
1. Highlight Reference Ranges from the TEST SETTINGS menu. Press edit.
2. Highlight ”on” button. Press next.
3. Enter a patient species for each reference range by deleting default name and
using alphanumeric keypad to spell name; i.e. canine, feline, equine, etc.
4. Select desired analyte from the picklist. If reference ranges will be entered for
multiple analytes, select “All”. Press edit.
5. Enter the lower reference limit and press next.
6. Enter the upper reference limit and press next.
7. Continue for all appropriate analytes.
8. Repeat steps 5-7 for each sample type; arterial,
venous,etc.
9. Repeat steps 3-7 for each new species added.

Activating QC Lock out
1. The QC Lock out option prevents
patient tests from being run prior to
EQC.
2. To activate, press QC Lockout on the
QC Settings menu.
3. The Select Product Type screen
displays a product type picklist.
4. Highlight the desired product type and
press edit.
5. Press “on” to activate or “off” to
deactivate
6. QC Lockout for the selected product
type and press next.
7. The Analyte Lockout screen displays
when “on” is selected.

Performing a Patient and QC
Testing

Running a Patient Test
• Select cartridge.
• Insert cartridge into instrument.
• Select product type.
• Verify lot number and cal code.
• After calibration, inject sample when prompted.

Sample Type and Amount
• Acceptable Specimen:
– Fresh arterial or venous blood collected in a 1, 2 or
3 mL heparinized syringe. (Li Heparin preferred.)
– Fresh capillary whole blood collected in the IRMA
TRUpoint capillary Device.
– A 1 mL syringe is recommended for sample
volumes < 400 uL.
– Sodium heparin should not be used for electrolyte
testing. (Acceptable for Blood Gas only testing.)
• Sample Size:
– 200 uL if sample is collected in syringe.
– 125 uL if sample is collected in an IRMA TRUpoint
capillary tube.

Sample Injection Tips
• Do not inject the entire syringe contents, i.e. “bottom
out” syringe.
• Prevent by resting a finger on top of syringe flange.
• Verify sample path is completely filled with sample
and electrodes are covered.
• Verify no bubbles or calibrant are present in the
sample path.
• If present, slowly inject additional sample to push
bubbles through sample path.

Injecting a Capillary Sample
• Collect sample and fill capillary tube.
• When blood contacts the white plug, the device is
filled.
• Following cartridge calibration, firmly seat the
capillary tube tip into the cartridge injection port.
• Anchor device with your fingers and slip the black
plunger into the capillary tube.
• Quickly depress the plunger straight down.
• Verify there is no calibrant or bubbles in sample
path.

Running an LQC Sample
Use RNA Controls for all cartridges except the CR cartridge.
• Access the Main menu.
• Press QC test. (Always run in QC Mode.)
• Press liquid (LQC).
• Select cartridge type to be tested.
• Open cartridge and insert into analyzer.
• Select the control to be tested, press next.
• Shake the control for ~10 seconds., set the control down.

Running an LQC Sample (Cont’d)
• Carefully snap open the control ampule
• Draw the control sample into a non-heparinized
syringe using a large bore 18-20 gauge needle.
**Unlike with a patient sample, do not invert the
syringe to expel air bubbles. Keep the needle
pointed down.
• Remove the needle from the syringe and place
syringe in the cartridge port.
• Press test and when prompted gently inject
entire contents of the syringe into the cartridge.
• If QC results are within limits, press done. If
outside the limits, press “notes” and document
problem.

Recalling Patient and QC Data
Press the “Recall” button on the Main Menu and select
from the following options:
• Patient: Search by patient ID and/or date range, or recall
the last test performed. Test information can be modified
only when recalled by “last result”.
• QC: Search by QC type (All, Aqueous, EQC, or
Temperature), control lot/level, and/or date range, or recall
results for the last QC test performed. QC actions can be
modified only when recalled by “last result”.

Running a Creatinine Control
Must use special IRMA CR controls
1. Press QC test.
2. Press liquid.
3. Select CR as product type to be tested.
4. Open cartridge and insert into analyzer.
5. Select the control to be tested, press next.
6. Place the syringe in the cartridge luer port.
7. Press test. Inject sample when prompted.
8. If QC is within limits , press done. If outside limits,
press notes and document.

Quality Control
• Following method verification and establishment of liquid
quality control, ITC recommends EQC as the primary method
of assessing system accuracy and precision.
• ITC recommends that QC be performed as follows:
EQC LQC Temp Test
When: ▪Once per 8 hr. shift
▪If analyzer experiences a
significant change in temp.
▪When performance of
analyzer requires verification.
▪Run 2 levels prior to
putting a new lot or
shipment of cartridges
into use.
▪Test again if cartridges
require an additional
equilibration period due
to temperature
fluctuations.
•Run monthly to verify
that analyzer temp
control system is
operating properly.
• Each test site may have unique requirements and should select and
verify a control system that meets their guidelines.

Maintenance

Changing Printer Paper
• Replace paper when a red stripe displays on the roll.
• Remove the printer door and follow on screen
instructions, pressing next to see additional
instructions.
• Remove the paper spindle and insert into the center
paper roll.
• Place the spindle into the cradle of the paper
compartment.
• The paper must unwind under the spindle.
• Insert the paper into the feed slot ensuring that the
tab is under the roller. Use a clean edge or fold
corners into a point. Press the “feed” button.
• Replace the printer door.

Calibrating the Barometer
1. Run an EQC test.
2. Compare the IRMA TRUpoint barometric reading to
the reference barometer reading by accessing
DEVICE SETTINGS from the SETTINGS OPTIONS
menu.
3. Scroll down until Calibrate Barometer is highlighted.
4. IRMA TRUpoint's current barometric pressure
displays below the DEVICE SETTINGS scroll box.
5. Compare the value displayed on IRMA TRUpoint to
the reference barometer. If they are the same, press
done.
6. If the barometer needs adjustment, press edit and
enter the value from the reference barometer.
7. IRMA TRUpoint accepts values from 350 - 900
mmHg.
8. Save the value.
*Barometer should be calibrated annually.

Cleaning the Analyzer
• Clean:
– Analyzer surface as needed with isopropyl
alcohol, a 10% bleach solution, or distilled
water.
– The IR probe (glass window in front of the edge
connector ) with isopropyl alcohol or a 10%
bleach solution.
– The temperature card leads as needed using a
swab moistened with isopropyl alcohol, or use a
clean pencil eraser.
– Use IRMA edge connector cleaning kit when
results indicate a problem with connector
contacts. (See next slide.)

Cleaning the Edge Connector
1. Remove battery or AC adapter from IRMA TRUpoint Analyzer.
2. Open and completely unfold WET pad. Place pad in front of the
edge connector.
3. Use Edge Connector Cleaning Strip to push pad gently into
edge connector.
4. Pull pad out of edge connector.
5. Repeat cleaning, moving pad left and right in edge connector.
6. Pull pad out of edge connector.
7. Open and completely unfold DRY pad.
8. Place pad in front of the edge connector and repeat steps 3
through 5.

Replacing the Edge Connector
1. Remove the power source from the analyzer.
2. Remove the right and left cartridge guides.
3. Remove the edge connector assembly by removing the two
thumbscrews from the underside of the analyzer.
4. Lift the edge connector assembly off of the analyzer.
5. Make sure that the connector on the analyzer is dry and that
no foreign materials are present before installing the new
edge connector.
6. Place the new edge connector into the analyzer and push
down on the assembly until the cover is flush with the
instrument top.
7. Reinsert the left and right guides by sliding each along the
edge of the porch until they snap into the edge connector
assembly.
8. Reinstall the two thumbscrews from the bottom of the
analyzer while holding the cover in place.
9. Following installation, verify that a cartridge can be inserted
into the edge connector. Perform an EQC test to verify
functionality of the analyzer.

Troubleshooting

Error Codes
• IRMA TRUpoint performs electronic checks each time it is
powered-up and whenever a cartridge is inserted.
• IRMA software continuously monitors the following items
throughout both the calibration and sample analysis phases:
– Response of sensors
– Infrared temperature probe
– Battery voltage
– Cartridge-analyzer connection
• If a cartridge or other system component fails to meet the
software criteria, a message code will result and the user
will be instructed to take corrective actions.

Error Codes (Cont’d)
• If a cartridge or other system component fails to meet the
software criteria, a message code will result.
• Message codes fall into the following categories:
– 1xxx Environmental Messages - IRMA or cartridge is
outside the 12-30C temperature operating range.
– 2xxx User Error - User has induced an error by
removing cartridge prematurely, failing to make an
entry within the allotted time, or failing to inject the
sample within the allotted time.
– 3xxx Low Battery Messages
– 4xxx Software Upgrade

Error Codes
• 5xxx Sensor Errors - Cartridge or other system
component has failed to meet software criteria. Repeat
the test with a new cartridge.
• 6xxx Instrument Errors - Software has detected a
problem with the analyzer. These errors are usually
non-recoverable and your service provider should be
contacted.
• 7xxx Currently not in-use
• 8xxx Data Down Loading Messages - Includes
warnings to download data to prevent overwriting
results (when memory is full or nearly full), and
downloading errors. (IDMS users, only.)

Troubleshooting-EQC Failure
• EQC Failure:
– Clean the edge connector and run another EQC test.
– If EQC fails again, call your service provider.
• Temperature Test Failure:
– Ensure that the analyzer and temperature card have
equilibrated to room temperature. If the temperature test fails,
wait 1 minute for the temperature card to cool down to room
temperature.
– Clean the IR probe. Allow alcohol to completely evaporate
before repeating the test.
– Clean the temperature card. Allow all alcohol to evaporate
before repeating the test.
– Rerun a temperature test using the same temperature card; if
the 2nd test fails, repeat test with a different temperature card
(if available).
– If the temperature test fails again, call your service provider.