LifeHealth irma User manual

User Manual

This manual is published by Lifehealth, an EasyDx, Inc. brand, for use with
the IRMA Blood Analysis System, Model LH, Version 1.1.3 or above.
Prior to use consult sections A.3, A.4 and B.4.
IRMA® is a registered trademark of EasyDx, Inc.
The Bluetooth® word mark and logos are registered trademarks owned by
the Bluetooth SIG, Inc. and any use of such marks by LifeHealth, an EasyDx,
Inc. brand is under license. Other trademarks and trade names are those of
their respective owners.
Android™ is a trademark of Google Inc.

Table of Contents
i
Table of Contents
Section 1: The IRMA Blood Analysis System�����������������������������������������������������������������1�1
1.1 Getting Started................................................................................................................................................................1.1
Unpack and Inspect the System .......................................................................................................................................................................1.1
Place the IRMA Tablet in the dock ....................................................................................................................................................................1.1
IRMA System Initial Language Setup ..............................................................................................................................................................1.2
Charge the IRMA System Batteries...................................................................................................................................................................1.2
Install the Printer Paper........................................................................................................................................................................................1.2
1.2 IRMA Blood Analysis System Components............................................................................................................1.3
Description ...............................................................................................................................................................................................................1.3
1.3 IRMA Base ..........................................................................................................................................................................1.3
1.4 IRMA Waking and Sleeping Modes ..........................................................................................................................1.4
1.5 IRMA Battery Operation................................................................................................................................................1.4
1.6 IRMA Cartridge Components .....................................................................................................................................1.5
1.7 IRMA Cartridge Care .....................................................................................................................................................1.5
Unpacking the IRMA Cartridges .......................................................................................................................................................................1.5
Equilibrating the IRMA Cartridges....................................................................................................................................................................1.5
1.8 IRMA Tablet .......................................................................................................................................................................1.6
Locking the IRMA Tablet into the dock...........................................................................................................................................................1.6
1.9 IRMA Tablet Main Menu................................................................................................................................................1.6
1.10 IRMA Touchscreen Interface .......................................................................................................................................1.6
IRMA Controls..........................................................................................................................................................................................................1.6
Buttons.......................................................................................................................................................................................................................1.6
Spinners.....................................................................................................................................................................................................................1.7
Checkboxes ..............................................................................................................................................................................................................1.7
Text Entry Area ........................................................................................................................................................................................................1.7
Motion Controls......................................................................................................................................................................................................1.7
Common Screen Items.........................................................................................................................................................................................1.8
Test Screen................................................................................................................................................................................................................1.8
Barcode Reader Screen ........................................................................................................................................................................................1.8
Keyboard Screen.....................................................................................................................................................................................................1.8
Instructional Screen...............................................................................................................................................................................................1.9
Wait Screen............................................................................................................................................................................................................ 1.10
Settings And Review Screen............................................................................................................................................................................ 1.10
Results Screen....................................................................................................................................................................................................... 1.10
Message Dialog.................................................................................................................................................................................................... 1.12
PDF Viewer Screen .............................................................................................................................................................................................. 1.12
Buttons and Icons................................................................................................................................................................................................ 1.13
1.11 IRMA Barometer ........................................................................................................................................................... 1.14
1.12 IRMA System Conventions........................................................................................................................................ 1.14
1.13 Before Initial Testing ................................................................................................................................................... 1.15
1.14 IRMA System Shipping and Long Term Storage ............................................................................................... 1.15
1.15 IRMA Intended Use......................................................................................................................................................... 1.15

Table of Contents
ii
Intended Use......................................................................................................................................................................................................... 1.15
CLIA Complexity Classication....................................................................................................................................................................... 1.16
Section 2: Patient Sample Analysis �������������������������������������������������������������������������������2�1
2.1 Sample Requirements...................................................................................................................................................2.1
Capillary Requirements........................................................................................................................................................................................2.1
Sample Size...............................................................................................................................................................................................................2.1
General Sample Collection Guidelines...........................................................................................................................................................2.1
Blood Gas Sample Handling...............................................................................................................................................................................2.1
Electrolyte Sample Handling..............................................................................................................................................................................2.2
2.2 Sample Injection .............................................................................................................................................................2.2
Injecting a Syringe Sample .................................................................................................................................................................................2.2
Injecting a Capillary Sample...............................................................................................................................................................................2.3
2.3 Patient Test Procedure .................................................................................................................................................2.4
Performing a Patient Test ..................................................................................................................................................................................2.4
2.4 Test Results........................................................................................................................................................................2.6
2.5 Additional Test Information ........................................................................................................................................2.6
All Cartridges ...........................................................................................................................................................................................................2.7
Blood Gas (BG) and Combo cartridge (CC)....................................................................................................................................................2.9
CC and H3............................................................................................................................................................................................................... 2.10
Section 3: Quality Control Testing���������������������������������������������������������������������������������3�1
3.1 IRMA Cartridges...............................................................................................................................................................3.1
3.2 IRMA Quality Control.....................................................................................................................................................3.1
3.3 LQC Material Handling..................................................................................................................................................3.2
LQC Materials...........................................................................................................................................................................................................3.2
CC, BG and H3 Control Materials Procedure.................................................................................................................................................3.2
3.4 Quality Control Recommendations..........................................................................................................................3.2
3.5 Electronic Quality Control............................................................................................................................................3.3
3.6 Running an LQC Test......................................................................................................................................................3.4
3.7 LQC Test Results...............................................................................................................................................................3.5
3.8 Temperature Quality Control......................................................................................................................................3.5
Section 4: Review������������������������������������������������������������������������������������������������������������4�1
4.1 Review Options Overview ...........................................................................................................................................4.1
4.2 Search Test Results .........................................................................................................................................................4.1
Last Results - Patient .............................................................................................................................................................................................4.1
Last Results - QC .....................................................................................................................................................................................................4.2
Search Patient Results...........................................................................................................................................................................................4.2
Search by Date: ......................................................................................................................................................................................................4.2
Search by Patient ID (PID): ..................................................................................................................................................................................4.3
Search by Operator ID (OID): .............................................................................................................................................................................4.3
Search QC Results...................................................................................................................................................................................................4.4
Search by QC Test Type and Date: ...................................................................................................................................................................4.4
Search by QC Test Type and Operator ID (OID): ..........................................................................................................................................4.4

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iii
4.3 IRMA Functions................................................................................................................................................................4.5
Software Update.....................................................................................................................................................................................................4.5
About IRMA ..............................................................................................................................................................................................................4.6
About Batteries .......................................................................................................................................................................................................4.6
About Licenses........................................................................................................................................................................................................4.6
Save Database .........................................................................................................................................................................................................4.6
Clear Database ........................................................................................................................................................................................................4.6
Restore Database....................................................................................................................................................................................................4.7
4.4 IRMA Logs..........................................................................................................................................................................4.7
Error Log ....................................................................................................................................................................................................................4.7
System Log ...............................................................................................................................................................................................................4.7
Communications Log............................................................................................................................................................................................4.7
Android Log..............................................................................................................................................................................................................4.7
Section 5: Troubleshooting��������������������������������������������������������������������������������������������5�1
5.1 Troubleshooting General Operational Problems................................................................................................5.1
IRMA Base or IRMA Tablet Does Not Turn On ...............................................................................................................................................5.1
Battery Problems ....................................................................................................................................................................................................5.1
Printer Problems .....................................................................................................................................................................................................5.2
IRMA Tablet Problems...........................................................................................................................................................................................5.2
Inconsistent Test Results......................................................................................................................................................................................5.2
EQC Failures..............................................................................................................................................................................................................5.3
Temperature Test Failures....................................................................................................................................................................................5.3
5.2 Troubleshooting Specic Operating Problems....................................................................................................5.4
Sensor Errors ............................................................................................................................................................................................................5.4
Procedural Errors ....................................................................................................................................................................................................5.4
Entry Errors ...............................................................................................................................................................................................................5.4
Temperature Errors ................................................................................................................................................................................................5.5
Analyzer Problems .................................................................................................................................................................................................5.5
Section 6: IRMA Component Replacement�������������������������������������������������������������������6�1
6.1 Replacing the Edge Connector..................................................................................................................................6.1
6.2 Replacing the IRMA Base Battery..............................................................................................................................6.2
6.3 Replacing the Printer Door..........................................................................................................................................6.2
6.4 Replacing the Printer Module ....................................................................................................................................6.3
6.5 Replacing the Dock........................................................................................................................................................6.4
6.6 Replacing the IRMA Tablet...........................................................................................................................................6.4
Section 7� Cleaning the IRMA Blood Analysis System �������������������������������������������������7�1
7.1 Cleaning Solutions .........................................................................................................................................................7.1
7.2 Cleaning the IRMA Tablet.............................................................................................................................................7.1
7.3 Cleaning the IRMA Base................................................................................................................................................7.1
7.4 Cleaning the Infrared Sensor......................................................................................................................................7.1
Section 8: IRMA System Settings�����������������������������������������������������������������������������������8�1

Table of Contents
iv
8.1 Settings Options Overview .........................................................................................................................................8.1
8.2 Operator ID Settings......................................................................................................................................................8.2
OID Required............................................................................................................................................................................................................8.2
Password Required ................................................................................................................................................................................................8.2
Edit OID List..............................................................................................................................................................................................................8.2
OID on Reports........................................................................................................................................................................................................8.3
OID Barcode Mask..................................................................................................................................................................................................8.3
8.3 Patient ID Settings..........................................................................................................................................................8.4
PID Required ............................................................................................................................................................................................................8.4
Default PID................................................................................................................................................................................................................8.4
PID Length ................................................................................................................................................................................................................8.4
PID Entry Mask.........................................................................................................................................................................................................8.4
PID Barcode Mask...................................................................................................................................................................................................8.5
8.4 Cartridge Settings...........................................................................................................................................................8.6
Cartridge Conguration.......................................................................................................................................................................................8.6
Manage Cartridge Lots.........................................................................................................................................................................................8.6
Add New Lot Entry During Testing...................................................................................................................................................................8.7
Manage LQC Material Lots..................................................................................................................................................................................8.7
8.5 Analyte Ranges................................................................................................................................................................8.9
Patient/Sample Type Setup ................................................................................................................................................................................8.9
Patient Specic Reference Range.................................................................................................................................................................. 8.10
Patient Reference Range................................................................................................................................................................................... 8.10
Master Reference Range................................................................................................................................................................................... 8.11
Master Reference Range Setup ...................................................................................................................................................................... 8.11
Reportable Ranges ............................................................................................................................................................................................. 8.12
Reportable Range Setup................................................................................................................................................................................... 8.12
8.6 QC Lockout Settings ................................................................................................................................................... 8.13
EQC Lockout Settings ........................................................................................................................................................................................ 8.13
8.7 Test Settings................................................................................................................................................................... 8.14
Allen's Test Range................................................................................................................................................................................................ 8.14
Hct Bypass Correlation Mode.......................................................................................................................................................................... 8.14
Hct Bypass Correlation Setup ......................................................................................................................................................................... 8.15
Physician Entry Mode ........................................................................................................................................................................................ 8.15
Manage Physician List ....................................................................................................................................................................................... 8.16
User Note Entry Mode ....................................................................................................................................................................................... 8.16
Manage User Notes List .................................................................................................................................................................................... 8.17
Units of Measure Settings ................................................................................................................................................................................ 8.17
Calculating Slope and Intercept for Hct Bypass Correlation................................................................................................................ 8.18
8.8 ABG Test Settings ......................................................................................................................................................... 8.19
Oxygen Therapy Mode...................................................................................................................................................................................... 8.19
Congure Oxygen Devices .............................................................................................................................................................................. 8.19
Congure Oxygen Ventilators......................................................................................................................................................................... 8.20
Patient Temperature Entry ............................................................................................................................................................................... 8.21
SpO2 Source.......................................................................................................................................................................................................... 8.21
BE and HCO3 Formula ....................................................................................................................................................................................... 8.22
pO2 Temperature Correction .......................................................................................................................................................................... 8.22

Table of Contents
v
Source of Hemoglobin for BE.......................................................................................................................................................................... 8.22
Backup Source of Hemoglobin....................................................................................................................................................................... 8.22
8.9 Device Settings............................................................................................................................................................. 8.23
Congure Wi ....................................................................................................................................................................................................... 8.23
Inactivity Timeout ............................................................................................................................................................................................... 8.24
Barcode Reader Timeout .................................................................................................................................................................................. 8.24
Audible Alerts ....................................................................................................................................................................................................... 8.24
Congure IRMA Base.......................................................................................................................................................................................... 8.24
Congure IRMA Printer...................................................................................................................................................................................... 8.25
Language ............................................................................................................................................................................................................... 8.26
Use Network Date and Time............................................................................................................................................................................ 8.26
Set Date................................................................................................................................................................................................................... 8.26
Set Time .................................................................................................................................................................................................................. 8.27
Set Time Zone....................................................................................................................................................................................................... 8.27
Set Time Format................................................................................................................................................................................................... 8.27
Set Date Format ................................................................................................................................................................................................... 8.27
Appendix A: Limitations and Safety Precautions ������������������������������������������������������� A�1
A.1 Limitations........................................................................................................................................................................ A.1
A.2 Common Sources of Sampling Errors..................................................................................................................... A.1
A.3 Interferences.................................................................................................................................................................... A.2
A.4 Safety Precautions for Blood Handling.................................................................................................................. A.3
A.5 Other Safety Precautions ............................................................................................................................................ A.3
A.6 References ........................................................................................................................................................................ A.4
Appendix B: Specications and Cartridge Information ����������������������������������������������B�1
B.1 IRMA System Specications........................................................................................................................................B.1
B.2 Device Disposal - At End of Useful Life....................................................................................................................B.2
B.3 Directives, Safety, Emissions, and Immunity.........................................................................................................B.2
Wireless QoS & Range Requirements..............................................................................................................................................................B.3
Wireless Security Recommendations..............................................................................................................................................................B.3
Simplied DoC.........................................................................................................................................................................................................B.3
Warnings and Precautions: .................................................................................................................................................................................B.4
B.4 Symbol Denition...........................................................................................................................................................B.4
B.5 Patents ................................................................................................................................................................................B.5
B.6 Cartridge/Analyte Congurations ............................................................................................................................B.5
B.7 Cartridge Storage and Equilibration Times ...........................................................................................................B.5
B.8 Reportable Ranges.........................................................................................................................................................B.5
B.9 Display Resolution..........................................................................................................................................................B.6
B.10 Correlation Factor Limits..............................................................................................................................................B.6
B.12 Wireless Coexistence ........................................................................................................................................................B.7
B.13 References .........................................................................................................................................................................B.7

Table of Contents
vi
Appendix C: Principles of Operation�����������������������������������������������������������������������������C�1
C.1 Measurement Technology.......................................................................................................................................... C.1
C.2 Calculated Parameters ................................................................................................................................................. C.1
C.3 References ........................................................................................................................................................................ C.3
Appendix D: Performance Characteristics ������������������������������������������������������������������ D�1
D.1 Accuracy............................................................................................................................................................................ D.1
D.2 Precision............................................................................................................................................................................ D.1
D.3 Linearity............................................................................................................................................................................. D.2
Appendix E: Default Settings ����������������������������������������������������������������������������������������E�1
Appendix F: Warranty����������������������������������������������������������������������������������������������������� F�1
F.1 Limited Warranty............................................................................................................................................................. F.1
F.2 Limitation of Remedies................................................................................................................................................. F.1
F.3 Warranty Disclaimer....................................................................................................................................................... F.1

1 IRMA Blood Analysis System Overview
1.1
Section 1: The IRMA Blood Analysis System
This section covers general information about the IRMA Blood Analysis System and describes the
installation process.
1.1 Getting Started
Unpack and Inspect the System
The IRMA Blood Analysis System is shipped with the
following components (Figure 1.1):
• The IRMA Base (1) with the dock (2) and removable
IRMA Tablet (3). The IRMA Tablet is packaged sepa-
rately.
• AC power supply (4)
• Temperature card (5) located in the storage area
• IRMA tool (6) located in the storage area
• Thermal paper (7)
• USB 2.0 Fast Ethernet Adapter (8)
Unpack and verify that all components have been received
and inspect the components for shipping damage.
Immediately report any shipping damage to your service
provider.
If multiple IRMA Systems are received, open and assemble only one at a time. The IRMA Tablet and the IRMA base are paired
before shipment and should be kept together.
Retain one set of packaging materials. IRMA Systems 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 obtain a
replacement.
Place the IRMA Tablet in the dock
The IRMA Tablet is packaged separately. To place the IRMA
Tablet in the dock (Figure 1.2):
• Orient the IRMA Tablet so that the connector
pins (10) are on the left side.
• Locate the connector pins (11) on the dock. Holding
the IRMA Tablet at a slight angle, match the con-
nector pins and place the IRMA Tablet in the dock.
Powerful magnets located on the right side of the
IRMA Tablet hold it in place.
• Power on the IRMA Tablet by pressing the button on
the top left edge (12) until the screen display lights
up.
Figure 1.1
1
2
3
4
5
67
8
Figure 1.2
12
11 10

1 IRMA Blood Analysis System Overview
1.2
IRMA System Initial Language Setup
When the IRMA Tablet is powered on for the rst time, the Select
Language screen appears (Figure 1.3). To keep the IRMA Tablet in
English press the DONE button. To change the language, select the
desired language and press the DONE button.
Connect the AC power supply to the IRMA Base and Power Up
Connect the power cord to the AC power supply. Place the barrel plug of the AC power supply into the barrel jack located on
the right side of the base. Plug the power cord into a power outlet.
Charge the IRMA System Batteries
When the IRMA Tablet is in the dock, the IRMA Tablet battery as well as the IRMA Base battery are charged as needed when
connected to a power source. The IRMA Base and IRMA Tablet are shipped partially charged. To fully charge the IRMA Tablet
and IRMA base, connect to a power source for 7 hours.
Install the Printer Paper
Open the door of the printer and storage compartment by placing
your ngers in the cut out area located near the front of the door and
pull up as illustrated in Figure 1.4. Place the printer paper roll in the
depressed paper compartment with the paper unrolling from the
bottom of the roll (Figure 1.5). Unroll the paper and close the door
leaving about 1 inch (2.5 cm) of paper showing.
Bring the IRMA System to Operating Temperature
The IRMA System must be at operating temperature before use.
The operating range of the IRMA Analyzer is 12 to 30° C (54 to 86°
F). If the IRMA System is exposed to a temperature outside of that
range for a signicant period of time, an instrument temperature
error message may display. The IRMA System must equilibrate at a
temperature within the temperature operating range for a minimum
of 30 minutes before testing may begin.
Figure 1.4
Figure 1.5
Figure 1.3

1 IRMA Blood Analysis System Overview
1.3
1.2 IRMA Blood Analysis System Components
Description
The major components of the IRMA System include the portable, battery-operated IRMA Base with the removable IRMA
Tablet, and IRMA cartridges that contain sensors and a calibrant. Cartridges come in a variety of analyte congurations.
Cartridges calibrate with every test using the self-contained calibrant. Instructions displayed on the IRMA Tablet guide the
user through the testing process. Patient and sample information is entered during analysis and test results are displayed in as
little as 30 seconds after sample injection. Results may be printed or transferred.
1.3 IRMA Base
The IRMA Base has the following features:
Front View (Figure 1.6)
1. IRMA Base: The IRMA Base is
paired with the IRMA Tablet
via a Bluetooth connection.
2. Integrated printer: Prints hard
copies of test results and asso-
ciated information. The printer
is paired with the IRMA Tablet
via a Bluetooth connection.
3. Removable IRMA Tablet:
Guides the user through all
aspects of IRMA operation.
4. Dock: Holds and charges the
IRMA Tablet when the IRMA
System is connected to the AC
power supply.
5. AC power supply barrel jack.
6. Edge connector block: Electri-
cally connects the cartridge to
the IRMA System.
7. Infrared (IR) sensor (recessed): Measures and
controls the sample temperature.
8. Storage area (accessed by opening the printer door) that holds the IRMA tool, temperature card and thermal paper
roll.
9. Temperature card: Used to verify that the temperature control system is operating properly. The temperature card is
found in the storage area (8).
10. IRMA tool: Used for locking the IRMA Tablet to the dock, for replacing the printer cover, and for replacing the edge
connector, printer, and/or battery, if needed. The IRMA tool is found in the storage area (8).
Figure 1.6
12
3
4
5
68
7
9
10

1 IRMA Blood Analysis System Overview
1.4
Side View (Figure 1.7)
11. Wake button.
12. Power cord connection (barrel jack).
13. USB port.
14. LED Indicators indicate whether the base is in wake or sleep
mode (white LED) and if the IRMA System requires charging
(green/amber LED) or is charging one or both of the IRMA
System's batteries.
The use of unapproved accessories may compromise safety when
using the IRMA System.
1.4 IRMA Waking and Sleeping Modes
The user can set how long the IRMA Tablet is inactive before entering sleep mode (refer to Section 8.9). To wake the IRMA
Tablet and IRMA Base, briey press the wake button on the IRMA Base. Upon waking, the Main Menu will be displayed or, if
the Operator ID feature is enabled, the Operator ID Login screen will be displayed. If the IRMA Tablet is not connected to the
IRMA Base, wake the IRMA Tablet by briey pressing the IRMA Tablet power button.
The state of the base is indicated by the white LED indicator as follows:
Base Sleep/Wake LED
Wake Mode Solid white
Sleep Mode Blinking white
Note: The IRMA Base will only enter Sleep Mode when operating on battery�
1.5 IRMA Battery Operation
When fully charged, the IRMA System can run approximately 40 to 80 tests depending on the type of cartridge used and
the amount of printing required. The battery level indicator for the IRMA System is located on the IRMA Tablet screen. The
charging time required for the IRMA Base battery or IRMA Tablet battery is approximately 7 hours.
The battery status is indicated by the green/amber LED as follows:
Base Power Indicator LED
Batteries are charging Blinking green
IRMA System requires charging Blinking amber
The IRMA Base battery is replaceable. Instructions for replacing the IRMA Base battery are found in Section 6.2. The battery in
the IRMA Tablet is not replaceable.
If the IRMA Tablet battery is completely discharged, the IRMA System requires a minimum of ten minutes of charging before it
may be used. The IRMA Tablet must be placed in the dock, and the IRMA Base must be connected to the AC power supply, in
order for its battery to charge.
CAUTION: During a cartridge test, Patient, LQC or TQC, do not plug or unplug the AC power supply into the
IRMA Base if the test is started� Plugging or unplugging the AC power supply into the IRMA Base during a test
will result in an error and the test being aborted�
11
12 13
14
Figure 1.7

1 IRMA Blood Analysis System Overview
1.5
1.6 IRMA Cartridge Components
Each IRMA cartridge contains a sensor array and self-contained
calibrant (Figure 1.8). Each cartridge can perform one patient or
liquid QC test.
1. Cartridge leads: electrically connect the cartridge to the IRMA
System.
2. Luer injection port: where the sample collection device
attaches to the cartridge.
3. Sensors: measure analyte concentrations.
4. Calibrant gel: used to calibrate the sensors for cartridges that
do not have a snap cap.
5. Waste reservoir: holds a maximum volume of 5 mL.
6. Temperature monitoring access sites as shown in Figure 1.9:
where the IR sensor measures and controls sample temperature (located on the bottom of the cartridge).
1.7 IRMA Cartridge Care
Unpacking the IRMA Cartridges
IRMA cartridges are ordered, packaged, and shipped under separate
cover in an insulated shipping container. The shipping temperature
range is 0 to 50°C. Check the temperature indicators that are
included in each shipping container. Refer to the instructions that
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.
Store the cartridges at room temperature. Refer to Appendix B,
Section B.7 for additional cartridge storage information.
Equilibrating the IRMA Cartridges
All cartridges must be equilibrated before use. Remove the cartridges from their shipping container and equilibrate to room
temperature in an area that has a stable temperature between 15 to 30°C (59 to 86°F) with no uctuations greater than 8°C
(14.4°F). Equilibration times vary by product and are found in Appendix B, Section B.7.
If the storage area temperature uctuations are greater than 8°C or 14.4°F, the cartridges must go through an additional
equilibration period before they can be used. Proper conditions should be documented by recording the daily minimum and
maximum storage area temperatures.
3
1 2 34 5
Figure 1.8
Figure 1.9
Bottom View of Cartridges Showing
Temperature Monitoring Sites
6

1 IRMA Blood Analysis System Overview
1.6
1.8 IRMA Tablet
Locking the IRMA Tablet into the dock.
The IRMA Tablet can be removed from the dock when needed. To
prevent the IRMA Tablet from being removed, there are two recessed
screws located on the right side of the dock that can be deployed
into the IRMA Tablet using the IRMA tool located under the printer
door (Figure 1.10). Tighten each screw until it is nger tight. To
remove the IRMA Tablet, loosen the screws with the IRMA tool until
resistance is felt. The screws are designed so that they cannot be
removed from the dock.
1.9 IRMA Tablet Main Menu
There are ve options displayed on the Main Menu. Each are briey
described below.
• Patient Test: Used for performing a whole blood patient
sample analysis.
• QC Test: Used for performing an Electronic Quality Control
(EQC) Test, Liquid Quality Control Tests (LQC), and Tempera-
ture Verication (TQC) Test.
• Review: Used for accessing test results, viewing the logs
and other instrument functions.
• Settings: Used to congure and/or edit all IRMA System
settings including Operator ID and Patient ID settings, An-
alyte Ranges, Cartridge Settings, QC Lockout Settings, Test
Settings, Device Settings, and ABG Test Settings.
• Instructions For Use icon: A pdf copy of the IRMA System user manual can also be accessed from the main menu. A
searchable pdf copy of the manual may be downloaded from www.lifehealthmed.com.
1.10 IRMA Touchscreen Interface
The IRMA Tablet uses a combination of symbols, text, video, controls (buttons, spinners, text entry and checkboxes) and
motions (pressing, swiping and pinching) through which the operator interacts and controls the IRMA System to perform
testing, review test results and congure the IRMA System. The user is guided through each procedure using screens
containing easy to understand directions, buttons, graphics, and video clips (where appropriate).
IRMA Controls
The operator uses buttons, spinners, checkboxes and text entry areas to perform actions and input data into the IRMA System.
Buttons
The various types of buttons the IRMA Touchscreen Interface uses are:
• Selection: Selection buttons are used to navigate through
the IRMA Touchscreen Interface and vary in shape and color.
• Action: Action buttons are green, orange or blue and appear
at the bottom of the screen or in the keyboard area. They
perform the action of the text displayed on them.
• Multi-Select: Used to input data or congure the IRMA
System. Zero or more buttons may be selected. A multi-select
button turns blue and displays a checkmark in it when select-
ed. When de-selected it is grey with no checkmark.
• Radio Button: Used to make a single selection. A radio but-
ton turns blue and has a dot inside the circle when selected.
When de-selected it is grey with only a circle displayed.
Figure 1.10

1 IRMA Blood Analysis System Overview
1.7
Spinners
The spinner control is primarily used for entering numeric data when
there are a limited number of possible entries. To use the spinner
control:
• Touch the center of the control and swipe up to change the
selection to a selection below the center position. Swipe
down to change the selection to a selection above the center
position.
• If there is no text above the center position the spinner can
only be swiped up. If there is no text below the center posi-
tion the spinner can only be swpied down.
• The selection in the center blue box is the selected data
point.
Checkboxes
The checkbox control is used to turn a function on a screen on or o.
• Press the box once and a checkmark appears in it. The func-
tion is on.
• Press the box again and the checkmark is removed. The
function is o.
Text Entry Area
The text entry area is used with the keyboard or barcode reader. It is
described below under the Keyboard Screen.
Motion Controls
The IRMA Tablet uses a touchscreen that is responsive to the following motions controls:
• Pressing: Touch the screen with your nger or a stylus make a selection.
• Swiping: Touch the screen and then drag your nger or a stylus either up or down (scrolling) or drag it either to the
right or to the left (swiping.) When there is additional information displayed on a screen, as indicated by a thin, verti-
cal, grey line, it is viewed by scrolling the screen.
- When multiple test records are retrieved from a search (Section 4 - Review), moving from one record to the next is
done by swiping to the left or right.
• Pinching: Touch the screen with two ngers and slide the tips of each nger together to zoom out of the text. Touch
the screen with two ngers close together and spread the tips of each nger away from the other to zoom in on the
text. The user manual is the only portion responsive to pinching.
Note: Touchscreen sensitivity varies from individual to individual and may be aected by various factors like
the amount of moisture on the skin� As a result, the touchscreen performance experienced by some operators
may be compromised� For operators that experience an ongoing issue with touchscreen responsiveness, the
use of a touchscreen stylus is recommended�
Note: The IRMA Tablet's touchscreen may be used while wearing nitrile, vinyl or latex gloves� If a glove liner
is to be worn, the use of a cotton or nylon glove liner is recommended� The use of polyester glove liners is not
recommended as they have been shown to aect the touchscreen's responsiveness�

1 IRMA Blood Analysis System Overview
1.8
Common Screen Items
Specic instructions for each section of the Main Menu (Patient Test, QC Test, Review and Settings) are contained in following
chapters. Common items to most screens are:
• Status Bar: When present, the status bar will be across the top of the screen. It displays the date and time and a series
of icons described in the Buttons and Icons section below.
• Action Buttons: Action buttons are green, orange or blue and appear at the bottom of the screen or in the keyboard
area. They perform the action of the text displayed on them.
• Keyboard Screen: The keyboard screen is used to enter alphanumeric information. It may be displayed in only two-
thirds of the screen or it may be displayed full screen.
Test Screen
The Patient and QC Test screens that require operator input use a
common layout the features of which are:
• Test Progress: The left third of the screen displays informa-
tion regarding the progression of the test. The yellow, bolded
text corresponds to the title of the test screen and the white,
italicized text is the information entered on the test screen.
There may be additional information not displayed on the
screen. To view the additional information the test progress
area may be scrolled.
• Test State: The right two-thirds of the screen displays the
current state of the test or requests information to be entered
by the operator.
Barcode Reader Screen
The barcode reader is located on the back of the IRMA Tablet in the upper left hand corner. The barcode reader is used to
enter information into the IRMA Tablet. Depending on how the IRMA System is congured the barcode reader screen may be
displayed automatically or by pressing the SCAN button when available.
To use the reader, place the red cross that appears in the center of the viewnder on the barcode to be scanned. Center the
barcode in the screen area and hold it steady to assist the autofocus in detecting the barcode. If the barcode does not scan
after a few seconds, slowly move it closer or further away from the IRMA Tablet. Shadows across the barcode or dim lighting
may make the barcode more dicult to detect. The IRMA Tablet will emit a beep when a barcode is successfully scanned. The
barcode reader uses image processing technologies and is not an eye hazard.
If the barcode reader does not detect a barcode within a certain amount of time it will return to the manual entry screen. The
barcode reader timeout feature is found in Device Settings (refer to Section 8.9) and can be set from 10 seconds to 3 minutes.
The features of the barcode reader screen are:
• Scan Window: The center of the window displays the bar-
code imager's eld of view with a red cross overlaid on it.
• The barcode reader can read the following symbologies:
• 1D formats - Code 39, Code 93, Code 128 & Codabar
• 2D formats - QR Code & Data Matrix
Keyboard Screen

1 IRMA Blood Analysis System Overview
1.9
The features of the keyboard screen are:
• Text Entry Area: There will be one or more white, text entry
areas. To the side of the text entry area, or inside the text en-
try area in light grey letters, will be text explaining the infor-
mation that should be entered. The input from the keyboard
buttons will be displayed in the selected text entry area. To
select a text entry area, press on it. A cursor will appear in it.
The cursor may not be moved by dragging it.
- When there are too many text entry areas to display above
the keyboard the text entry areas will scroll as a group
while the keyboard remains in its place.
• Keyboard Area: The blue keys displayed in the keyboard
area enter text in the selected text entry area when pressed.
The keys displayed are dependent on the information to be
entered in the text entry area. The green buttons are de-
scribed below:
- The ABC/123 button toggles between the alpha and
numeric keyboards.
- The ?123 button displays the numeric and symbols
keyboard.
- The backspace button removes the last character in the
text entry area.
- The shift key toggles between the upper and lower case
alpha keyboard or the main and alternate numeric and
symbols keyboard.
• Alternate Keys: Depending on the keyboard, and/or the language, dierent characters may be entered using the
same key. Keys with alternate characters are distinguished
with a small dot in the upper corner of the key. To enter an
alternate character:
- Press and hold a key with a smal dot. The characters that
may be entered will be displayed. Select the desired
character by pressing it.
- Tap a key with a small dot multiple times. Tapping twice
will enter the second alternate character. Tapping three
times will enter the third alternate character, etc...
Instructional Screen
The Patient and QC Test screens use a common layout the features of
which are:
• Test Progress: Instructional screens that are displayed
during a test use the same test progress area displayed in
the Test Screen section. Instructional screens that are not
displayed during a test will not have a test progress area.
• Instructions: Instructions to guide the operator through the
operator action are displayed in the center of the screen.
• Video Loop: A short video loop showing the action to be
taken may be displayed next to the instructions.
• Timer: Some operator actions must be completed within a
dened timeframe. A countdown will be displayed indicating
the time remaining before the IRMA System will cancel the
test or action.

1 IRMA Blood Analysis System Overview
1.10
Wait Screen
When no action is required of the operator a wait screen will display
the features of which are:
• Test Progress: Wait screens that are displayed during a test
use the same test progress area displayed in the Test Screen
section. Wait screens that are not displayed during a test will
not have a test progress area.
• Progress Animation: An animation showing the approxi-
mate time until the next screen is presented is displayed in
the center of the screen.
Settings And Review Screen
Most of the screens in the Settings and Review area use a common
layout the features of which are:
• Submenu list: The left third of the screen displays a column
of selection buttons (orange in Review, purple in Settings.)
Only one button may be selected at a time. The selected but-
ton is a brighter shade than the deselected buttons. When
more buttons are contained in the list than will display on the
screen, the submenu buttons are scrollable.
• Entry Area: The right two-thirds of the screen may display
informational text or, more commonly, groups of buttons,
spinners, a keyboard or another form of data input.
Results Screen
Patient and QC test results are displayed on the Results screen. The
Results screen is displayed at the end of a test and when test records
are retrieved in the Review area. Each measured and calculated
analyte is displayed on its own row. The features of the Results screen
are:
• Analyte Button: The analyte button displays the name of the
analyte, the analyte result, the analyte's unit of measure, and
any ags, in white text on a colored button or in black text on
a white button. The button color represents:
- Green: When the result is evaluated against a normal or
a normal and a critical reference range and is within the
normal range the analyte button is green.
- Orange: When the result is evaluated against only a
normal reference range and is outside the normal range
the analyte button is orange. When the result is evaluated
against a normal reference range and a critical reference
range and the result is outside the normal range and
inside the critical reference range the analyte button is
orange.
- Red: When the result is evaluated against a normal
reference range and a critical reference range and the
result is outside the critical range the analyte button is
red. When the result is outside of the reportable range
and is inside the IRMA System machine range, the

1 IRMA Blood Analysis System Overview
1.11
analyte result is reported as greater than or less than the
reportable range limit and the analyte button is red.
- White: When the result is not evaluated against a
reference range the analyte button is white.
- Grey: When the result cannot be calculated or when
the result is outside the IRMA range the result value is
suppressed. Three dashes are displayed instead of a result
value.
• The potential ags are:
- High: When the result is greater than the upper normal
reference range and less than the upper critical reference
range limit (if one is dened) a triangle pointing up is
displayed on the right hand side of the analyte button.
- Critical High: When the result is greater than the upper
critical reference range and less than the upper reportable
range limit two triangles pointing up are displayed on the
right hand side of the analyte button.
- Out of Range High: When the result is greater than the
upper reportable range and less than the upper IRMA
range a triangle pointing to the right is displayed on
the right hand side of the analyte button and a > sign is
displayed in front of the result.
- Low: When the result is less than the lower normal
reference range and greater than the lower critical
reference range limit (if one is dened) a triangle pointing
down is displayed on the right hand side of the analyte
button.
- Critical Low: When the result is less than the lower critical
reference range and greater than the lower reportable
range limit two triangles pointing down are displayed on
the right hand side of the analyte button.
- Out of Range Low: When the result is less than the lower
reportable range and greater than the lower IRMA range a
triangle pointing to the left is displayed on the right hand
side of the analyte button and a < sign is displayed in front of the result.
- Suppressed: When the result cannot be calculated or is less than the lower IRMA limit or greater than the upper
IRMA limit a X is displayed on the right hand side of the analyte button.
- Correlated Result: When On Bypass is selected a heart icon will appear on the left hand side of the analyte button
to indicate the hematocrit result was adjusted using the Hct Bypass Correlation slope and intercept values.
- Temperature Corrected Result: A thermometer icon will appear on the left hand side of the analyte button to
indicate the result was corrected for the patient temperature.
• Detail view: Press the Results Graph or the Analyte Button to toggle between the summary view of the analyte and
the detail view of the analyte. In detail view the result displays above the vertical results bar and the reference ranges
display below the bar graph.

1 IRMA Blood Analysis System Overview
1.12
• Results Graph: A bar graph of where the result falls inside its
range is displayed opposite the analyte button. The results
graph is divided into one, three or ve sections depending
on how many reference ranges are dened for the analyte.
- If both a normal and a critical reference range are dened
for the analyte, a bar with ve sections is displayed.
Results that are inside the normal range are displayed in
the center section. The sections just to the left and right of
the normal section are where the low and high results are
displayed. The outside two sections are where the critical
low and critical high results are displayed.
- If only a normal reference range is dened for the analyte,
a bar with three sections is displayed. Results that are
inside the normal range are displayed in the center section. The two outside sections are where the low and high
results are displayed.
- If there are no reference ranges dened for the analyte a bar with one section is displayed.
Note: For results that cannot have a reference range dened there is no Results Graph displayed�
Note: The vertical bar will be displayed relative to where the result falls within that reference range�
Message Dialog
If the operator attempts an action that is not allowed, or the IRMA
System needs to inform the operator of an issue requiring immediate
attention a message dialog is displayed. The message dialog is
partially transparent, covers the center of the screen and must be
addressed before returning to the screen behind it. The features of
the message dialog are:
• Instructions: Instructions to inform the operator of what is
required.
PDF Viewer Screen
Pdf formatted les are displayed in a screen with a pdf viewer. The
features of the PDF Viewer screen are:
• PDF View: The right, three-quarters of the screen is used to
display the pdf document. The document may be zoomed
by pinching. For multi-page documents scrolling will move
through the document one page at a time. On the far right
hand side of the document is a vertical line with a grey circle.
Sliding the circle up and down the vertical line will quickly
move through multiple pages of the document.
Note: The current page of the document must be at its
smallest size, fully zoomed out, in order to either scroll to
the next page or to use the slider bar�