Abbott e i-STAT Alinity User manual

i-STAT Alinity
Quick
Reference
Guide

SCOPE:
The Quick Reference Guide contains information that describes
several functional pathways of the i-STAT Alinity instrument.
i-STAT Alinity software expires periodically. Upon receipt of
a new or replacement instrument, check the expiration date of
the software by navigating to More Options > Instrument Status.
Instructions for updating software are found in the System
Operations Manual at www.pointofcare.abbott.
For additional information regarding the use of the
i-STAT Alinity instrument and i-STAT test cartridges, refer to
individual cartridge Instructions for Use and Systems Operation
Manual.
CONTENTS
Section 1: Instrument Setup (New Instruments) .............1
Section 2: System Components........................................7
Section 3: Anatomy of the Instrument .............................8
Section 4: Screen Components and Their Meanings.......9
Section 5: Cleaning & Disinfecting.................................14
Section 6: Troubleshooting .............................................18
Abbott Point of Care Inc.
100 and 200 Abbott Park Road
Abbott Park, IL 60064 USA
www.pointofcare.abbott
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
IVD
©2021 Abbott Point of Care Inc. All rights reserved. Printed in USA.
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

SECTION 1
ATTACH BATTERY AND POWER ON INSTRUMENT
Perform Paent Test
12APR2015 11:01
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More Opons
Perform Paent Test
12APR2015 11:01
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Perform Paent Test
12APR2015 11:01
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Perform Paent Test
12APR2015 11:01
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IF BATTERY SHOWS A YELLOW OR
RED BAR, CONTINUE TO STEP 3
IF BATTERY HAS SUFFICIENT
CHARGE CONTINUE TO STEP 4
1
CHECK FOR SUFFICENT BATTERY CHARGE
2
CHARGE BATTERY IF NEEDED OR MOVE TO STEP 4
3
1
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
INSTRUMENT SETUP (New Instruments)
Charge immediately
Charge needed soon
Aproximately
1/2 charged
Fully Charged

SECTION 1
4LOCATE REGION BAR CODE
a
b
OR
If instrument displays Set Region Code screen, proceed to STEP . If not,
proceed to STEP .
6
4
2
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
INSTRUMENT SETUP (New Instruments)

SECTION 1 3
Region Code Barcode Must Be Scanned
Instrument Disabled
Locate region code barcode on INSTRUCTIONS FOR USE document.
Touch Instrument Service to begin workflow.
Alerts 1 of 1
Set Region
Code
Exit Alerts
1. Touch Set Region Code
and follow prompts on
screen.
2. When prompted, scan
Region Code on box or
leer.
3. Connue to follow
prompts on the screen.
4. Once the instrument powers on, the Region Code Barcode
alert should no longer be displayed. Proceed to STEP . If Alert
screen displays again, repeat STEP . If the Alert screen displays
again, contact your Abbo representave.
TOUCH SET REGION CODE
5
5
6
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

SECTION 1
4
Power instrument on and follow sequence.
1
2
3
FINISH SETTING UP THE INSTRUMENT
6
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

SECTION 1 5
Set Clock
5
Set Language
4
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

SECTION 1
6
Set Units
6
Set Date Format
7
INSTRUMENT SETUP IS COMPLETE
8
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SECTION 2 7
1
3
5
2
4
6
SYSTEM COMPONENTS
6
i-STAT ALINITY INSTRUMENT: Used to perform cartridge testing,
reviewing test results, and conducting quality control (QC) testing.
i-STAT ALINITY BASE STATION: Used to recharge the battery
installed in the i-STAT Alinity.
i-STAT CARTRIDGES: Contains sensors and reagents for all patient
and quality testing.
i-STAT ALINITY RECHARGEABLE BATTERY: Provides main
power source to the instrument.
i-STAT ALINITY ELECTRONIC SIMULATOR: Provides an
independent check on the instrument’s thermal controls and success
of software updates.
i-STAT ALINITY PORTABLE PRINTER: Used to print records
stored in the instrument.
5
4
3
2
1

i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SECTION 3
8
LED: Indicates status of
the instrument.
GREEN: Instrument is starting
up or test results are complete.
WHITE: Cartridge is
processing.
RED: Requires immediate
attention.
BLUE: Battery is charging.
YELLOW: Instrument printing.
DISPLAY SCREEN
POWER BUTTON: Press and
hold button for 2 seconds to
power up or power down the
instrument.
BARCODE CAPTURE BUTTON:
Press and hold button in order
to capture a barcode. Audible
cues indicate successful and
unsuccessful barcode captures.
CARTRIDGE PORT: Cartridge
or Electronic Simulator is inserted
into the cartridge port to initiate
testing.
CAMERA AND IR PORT:
Camera is activated by pressing
and holding the barcode capture
button. The display screen
displays the object within the
cameras view. The IR port sends
information from the instrument
to the portable printer.
BATTERY: Rechargeable battery
is the sole power source for the
instrument.
ANATOMY OF THE INSTRUMENT

9
SECTION 4
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SCREEN COMPONENTS AND THEIR MEANINGS
After the power button is pushed and the instrument starts
the power-up sequence, the LED light will turn green,
and i-STAT Alinity will appear briey on the display
screen. During the power-up sequence, the i-STAT Alinity
instrument performs a series of self-checks.
If all the self-checks pass, the instrument will display the
Home screen.
If one or more self-checks fail, the instrument will display the
Alerts Screen.
Home Screen

More Opons
Perform Paent Test
Home
Home
16FEB2025 09:45
SECTION 4
10
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
If all self-checks pass at start up, the instrument will display
the Home screen.
Anatomy of a Home Screen:
A
HEADER Area Contains:
®Date/Time
®Wireless Status*
®Battery Status*
BBODY Area Contains:
®Buttons provide access to pathways
¯Perform Patient Test
¯More Options
CFOOTER Area Contains:
®Home Button
SCREEN COMPONENTS AND THEIR MEANINGS (CONT.)
A
B
C
* See Page 13 for screen icons and their meanings.
Home Screen

11
SECTION 4
Low Baery
Cartridge tesng will be disabled if baery is not recharged or replaced.
Recharge or replace baery as soon as possible.
Alerts 1 of 1
Exit Alerts
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SCREEN COMPONENTS AND THEIR MEANINGS (CONT.)
If one or more start up self-checks fail, the instrument will display
the Alerts Screen as shown in the example above.
Anatomy of Alerts Screen:
AWARNING or LOCKOUT ICON:
Indicates status of alert.
Instrument is locked until requirement is satised
or Instrument warning
BALERTS INDICATOR:
Displays number of alerts
CALERT TITLE
DALERT DESCRIPTION:
Displays cause and resolution
A
C
B
D
Alert Screen

Buon 1
Buon 2
Buon 3
Buon 4
Buon 2 Buon 3Buon 1
Page Title
Home
Alerts
Idenficaon Tab Acon
Tab 1
Message Area
SECTION 4
12
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SCREEN COMPONENTS AND THEIR MEANINGS (CONT.)
A generic pathway screen is shown in the example above.
Anatomy of a Pathway Screen
AHEADER:
® Identication Tab
¯Displays details such as patient ID, cartridge name, liquid
quality control name
®Header Action Tabs
¯Provide options for screen navigation
BPAGE TITLE
CMESSAGE AREA
DBODY:
®Buttons in this area provide access to pathways, OR
® Location of details such as data entry eld, help graphics,
selection options
ESIDE ACTION TABS:
®Provide access to area or action indicated
FALERT BUTTON:
®Provides access to Alerts description
GACTION BUTTONS:
®Provide options for screen navigation
A
B
D
F
G
C
E

SECTION 4 13
Home
16FEB2025 09:45
Home
16FEB2025 09:45
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SCREEN COMPONENTS AND THEIR MEANINGS (CONT.)
A B
C
Network Status
Connected
Disabled*
Alert Icons
Pass
Fail
Warning
Instrument
locked
Information
Low Battery
Wireless Status Battery Status
Best Fully charged
Very Good Approx. 1/2 charged
Good Charge needed soon
Fair Charge immediately**
Poor Bolt indicates actively charging
No Signal Charging
No
Connection
Wireless
Disabled*
Wireless
Connecting
Wireless
Not Allowed
Instructional Icons
Mandatory
A B C
*Disabled on instrument or via customization.
** Testing is disabled when the battery level is insufficient to perform a cartridge test.

SECTION 5
14
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
CLEANING
It is recommended that the i-STAT Alinity, base station and electronic
simulator be cleaned periodically or whenever visibly soiled.
Standard precautions should be taken whenever working with blood
or blood products.
SENSITIVE AREAS
When cleaning the i-STAT Alinity with CaviWipes, power off the
instrument and place it on a level surface. Do not clean or disinfect
the instrument while it is in the Base Station. The Base Station nor the
printer need to be unplugged when being cleaned.
Remove a new disposable wipe from the container and squeeze
to remove excess solution.
Gently wipe all outside surfaces (noting the “Sensitive Areas”) until
all visible soil is removed.
Inspect all surfaces. If necessary, repeat until all visible soil
is removed.
Wipe with dry gauze until dry.
1
2
3
4
5
i-STAT Alinity Instrument, Base Station, Printer and Electronic Simulator
Avoid forcing liquid into these areas:
i-STAT Alinity Instrument
Cartridge Port
10-Pin Connector under the camera
Gold contacts (2) on the outside of
the battery
A
B
C
D
E
F
Base Station
10-Pin Connector
Gold contact pins (2)
USB Port
D
E
F
Electronic
Simulator
Area between
protective cap
retaining ring
and white
sensor area
G
C
B
A

15
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SECTION 5
DISINFECTING
i-STAT Alinity Instrument
Disinfection is recommended between each patient. When instrument is
dedicated to a single patient, disinfect at least once a day. The disinfection
process must begin IMMEDIATELY after the cleaning procedure is
complete. Standard precautions should be taken whenever working with
blood or blood products.
Remove a wipe from the
container and squeeze out
any excess uid before you
begin to wipe the surface.
Wipe all surfaces three times.
This includes front, back, sides,
top and bottom.
WIPEWIPE
3X 3X
WIPE WIPE
3X 3X
W
I
P
E
3
X
3
X
1 2
3 4 Wipe with gauze
until dry.
Allow all
surfaces to
remain wet
for 3minutes.
SENSITIVE AREAS
Avoid forcing liquid into these areas:
i-STAT Alinity Instrument
Cartridge Port
10-Pin Connector under the camera
Gold contacts (2) on the outside of
the battery
A
B
CC
B
A

16
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
SECTION 5
DISINFECTING
Base Station, Electronic Simulator and Printer
4Wipe dry with gauze.
Remove a wipe from the
container and squeeze out
any excess uid before you
begin to wipe the surface.
Wipe the front as shown, ip products
on back side and repeat.
WIPE 3X
LEFT & RIGHT
1 2
WIPE 3X
UP & DOWN
SENSITIVE AREAS Avoid forcing liquid
into these areas:
D
E
F
Base Station
10-Pin Connector
Gold contact pins (2)
USB Port
D
E
F
Electronic
Simulator
Area between
protective cap
retaining ring
and white
sensor area
G
WIPE
3
X
3
X
3X 3X
3Allow all surfaces to
remain wet for 3minutes.

17
®Due to the portability of the i-STAT Alinity Instrument, it
may be subject to splatter or splash of bodily uids when used
in proximity of patients. Failure to wear clean gloves will
result in contamination of the instrument.
®Instruments used with multiple patients may require more
frequent cleaning and disinfecting. Cleaning is necessary for
the removal of visible organic soil. Disinfecting is intended to
kill microoganisms.
®Follow recommendations from the FDA and CDC and your
facility’s policies and procedures for infection control.
CaviWipes
EPA #46781-13
Note: Super-Sani Cloth is an
acceptable disinfecting option for all
markets except the United States.
APPROVED DISINFECTANT PRODUCTS
SECTION 5
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021

18 SECTION 6
i-STATAlinity — Quick Reference Guide Art: 731848-01 Rev K Rev. Date: 02-Apr-2021
TROUBLESHOOTING
The i-STAT Alinity is programmed to perform quality checks
throughout the testing cycle.
The instrument has several methods of notifying operators
of failed quality checks.
1. Quality Check Failures
- Are displayed when the instrument identies a problem
while running a cartridge or simulator
- There are 4 types of quality check failures:
1. Instrument
2. Cartridge
3. Sample
4. Software
- Screen displays the type of failure and instructions
for resolution
View Resoluon
Cause
Excess blood added to cartridge.
When filling this cartridge, the blood
advanced past the level indicated by
the 'fill to' arrow.
Help
?
Opons
Menu
Home
Cartridge Quality Check Failure
Cartridge Was Overfilled
Code: 37-01
Print
View
Entered Info
Opons
Menu
i-STAT CHEM8+
Pt: 654321
13OCT2025 08:33
View Cause
Cartridge Quality Check Failure
Resoluon
Cartridge Was Overfilled
When filling a cartridge, use care to
advance blood to the level indicated by
the 'fill to' arrow.
Repeat tesng with a freshly filled
cartridge.
Carefully observe the help provided
throughout the tesng pathway.
If the same quality check failure displays,
contact the system administrator for
further instrucon.
Code: 37-01
Help
?
Opons
Menu
Home
Print
View
Entered Info
Opons
Menu
i-STAT CHEM8+
Pt: 654321
13OCT2025 08:33