Abbott i-STAT Alinity User manual

i-STAT Alinity
Quick
Reference
Guide

i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022


i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
INTENDED USE:
The i-STAT Alinity instrument is intended for use in the in vitro quantication of
various analytes in whole blood or plasma in point of care or clinical laboratory
settings.
SCOPE:
The Quick Reference Guide contains information that describes several functional
pathways of the i-STAT Alinity instrument.
Instrument and cartridges should be used by healthcare professionals trained and
certied to use the system and should be used according to the facility’s policies and
procedures.
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 HOW TO
PERFORM SOFTWARE UPDATE section of this guide.
Images and illustrations provided in this user guide are for representational purposes
only.
Not all products are available in all markets. Contact your local Abbott Point of Care
representative for information on available products.
To obtain additional product information and technical support, refer to the Abbott
company website at www.globalpointofcare.abbott.
Product problems and adverse events should be reported to Abbott through your
Abbott Point of Care support service.
For a patient/user/third party in the European Union and in countries with identical
regulatory regime (Regulation 2017/746/EU on In vitro Diagnostic Medical Devices);
if, during the use of this device or as a result of its use, a serious incident has occurred,
please report it to Abbott and its authorized representative and to your national
authority.
INSTRUMENT SETUP (NEW INSTRUMENTS)
SYSTEM COMPONENTS AND PRECAUTIONS
ANATOMY OF INSTRUMENT
SCREEN COMPONENTS AND THEIR MEANINGS
CARTRIDGE INFORMATION
HOW TO PERFORM QUALITY TESTING
HOW TO PERFORM PATIENT TESTING
CLEANING AND DISINFECTING
TROUBLESHOOTING AND SUPPORT
HOW TO PERFORM SOFTWARE UPDATE
SYMBOLS, TERMINOLOGY AND TEST ABBREVIATIONS
SECTION 1:
SECTION 2:
SECTION 3:
SECTION 4:
SECTION 5:
SECTION 6:
SECTION 7:
SECTION 8:
SECTION 9:
SECTION 10:
APPENDIX 1:
CONTENTS

i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
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SECTION 1
ATTACH BATTERY AND POWER ON INSTRUMENT
Perform Paent Test
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Perform Paent Test
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Perform Paent Test
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Perform Paent Test
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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.
4HRS
1
CHECK FOR SUFFICIENT BATTERY CHARGE
2
CHARGE BATTERY IF NEEDED OR MOVE TO STEP 4
3
Home
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
New Instruments
Charge immediately
Charge needed soon
Aproximately
1/2 charged
Fully Charged
An alert displays when the battery level approaches the level at which testing
is disabled.

If instrument displays Set Region Code screen, proceed to STEP .
If not, proceed to STEP .
6
4
SECTION 1
4LOCATE REGION BAR CODE
a

OR
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
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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 letter.
3. Continue 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 Abbott representative.
TOUCH SET REGION CODE
5
5
6
SECTION 1 3
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SECTION 1
Power instrument on, follow sequence and on-screen instructions.
1
2
3
FINISH SETTING UP THE INSTRUMENT
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022

SECTION 1
Set Clock
5
Set Language
4
FINISH SETTING UP THE INSTRUMENT CONT.
6
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SECTION 1
Set Units
6
Set Date Format
7
INSTRUMENT SETUP IS COMPLETE
7
NOTE: Not all cartridges are available in all regions. Check with your local
representative for availability in specic markets.
FINISH SETTING UP THE INSTRUMENT CONT.
6
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022

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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
SECTION 2
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 testing
patient samples and quality uids.
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 PRINTER: Used to print records stored in the
instrument.
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4
3
2
1

SECTION 2SECTION 2
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
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i-STAT CARTRIDGE
See section HOW TO PERFORM PATIENT TESTING in this guide for details.
i-STAT ALINITY ELECTRONIC SIMULATOR
See section HOW TO PERFORM QUALITY TESTING in this guide for details.
i-STAT ALINITY INSTRUMENT
For best results, observe the following precautions to prevent damage to the
instrument, to ensure the safety of the operator and the integrity of the results.
DO:
• use care when placing the instrument on a surface that is unstable, such as
a patient bed. Placing the instrument on an unstable surface may cause the
instrument to fall. Place the instrument on a tabletop or counter to minimize the
likelihood of a fall.
• always place the instrument and peripherals on a stable surface or in a location
where they will not cause injury if dropped.
• use only the accessories and consumables specied or supplied for this system
by Abbott Point of Care.
• protect patients from nosocomial infections by disinfecting the instrument
periodically and whenever blood is spilled or transferred to an instrument.
• follow site specic guidelines for integration of wireless devices into a hospital
environment.
• keep the cartridge and the instrument at the temperature of the room where
they are to be used. Condensation on a cold cartridge can prevent proper contact
with the instrument.
• check with authorities for local, state, and/or national requirements for disposal.
DO NOT:
• attempt to remove a cartridge during the testing cycle. The force that would
be necessary to do so could damage the instrument. The message Cartridge
Locked in Instrument. Do Not Attempt to Remove the Cartridge. remains on
the screen until the instrument unlocks the cartridge.
• use the instrument in environmental conditions that exceed the operating
temperature and humidity specications.
• make any unauthorized repairs or modications to this product as this may
cause personal injury or damage to the unit.
PRECAUTIONS AND LIMITATIONS

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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY INSTRUMENT (CONT.)
NOTE:
• Protection provided by this equipment may be impaired if used in a manner not
specied by Abbott Point of Care.
• Operators should use standard precautions whenever handling the instrument,
cartridge, and peripherals to protect themselves from blood-borne pathogens.
Standard precautions, such as the wearing of gloves, are designed to protect
personnel from blood-borne pathogens and pathogens from other body
substances. These precautions are based on the assumption that blood, body
uids, and tissue can contain infectious agents and should therefore be treated
as biohazardous materials.
• The instrument can be rendered inoperative by damage caused by mishandling -
for example, dropping the instrument.
• Clinical settings that demand fail-safe testing should have a backup instrument
or test source available.
• The instrument and its peripherals are not listed by any authority with respect
to suitability for use in oxygen-enriched atmospheres.
• Synchronizing the instrument date/time to a data manager with an incorrect
date/time could render the instrument unusable. To disable automatic date/time
synchronization, run the Set Clock ow and uncheck the box Synchronize
Clock with Data Manager. Then press Set Date/Time manually and set the
correct date/time.

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SECTION 2
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY RECHARGEABLE BATTERY
Batteries have been designed to provide a safe, high-capacity power source in
a relatively small lightweight package. However, if misused or abused, these
batteries can be dangerous. Follow these guidelines for the safe handling, use and
disposal of the rechargeable batteries.
DO:
• refer to the Getting Started Guide for proper charging instructions.
• charge a new rechargeable battery pack for 4 hours before initial use. A fully
discharged battery will be 100% charged and ready for use after 4 hours.
• use only a rechargeable battery pack purchased from Abbott Point of Care.
• use only the accessories and consumables specied or supplied for this system
by Abbott Point of Care.
• keep a spare, charged battery on hand at all times.
• store charged battery in the original packaging.
• check with authorities for local, state, and/or national requirements for disposal
or recycling requirements for Lithium-Ion batteries.
DO NOT:
• dismantle, open or shred the battery.
• expose the battery to heat or re. Avoid storage in direct sunlight.
• short circuit the battery. Do not store batteries in such a manner that they may
short circuit each other, or allow metal objects to touch the battery contacts.
• subject the batteries to mechanical shock.
• open, disassemble, modify, crush, burn, shred, or expose to high temperatures.
Toxic gases and liquids are present in batteries.
• place the battery in an oxygen-enriched atmosphere.
• make any unauthorized repairs or modications to this product as this may
cause personal injury or damage to the unit.

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SECTION 2 11
i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY RECHARGEABLE BATTERY (CONT.)
NOTE:
• A fully charged battery, if not periodically recharged, will self-discharge over
time. Prevent self-discharge by keeping the rechargeable battery pack in an
instrument that is on a powered Base Station.
• Protection provided by this equipment may be impaired if used in a manner not
specied by Abbott Point of Care.
• The instrument and its peripherals are not listed by any authority with respect
to suitability for use in oxygen-enriched atmospheres.
• In the event of a battery leaking, do not allow any leakage to come into contact
with the skin or eyes. If contact has been made, wash the affected area with
copious amounts of water and seek medical advice.

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SECTION 2
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY BASE STATION
For safety when using the Base Station:
DO:
• use only the accessories and consumables specied or supplied for this
system by Abbott Point of Care.
• use only the power supply shipped in the box with the Base Station.
Attempting to use a different type of manufacturer’s adapter could damage
the unit and cause re or explosion hazards.
• be sure to install all cables and power supplies so they do not pose a trip
hazard. Mount equipment so cables and accessories stay clear of walkways.
• always use the Base Station for charging. Refer to the rechargeable battery
Getting Started Guide on instructions for proper charging.
• connect only Abbott Point of Care provided printers to the Base Station
printer port.
• check with authorities for local, state, and/or national requirements for
disposal.
DO NOT:
• try to connect any non-electrically isolated equipment to the Base Station.
• connect the Base Station to unauthorized medical devices or other
equipment.
• place metal objects on or near the exposed battery charging contacts.
• place the instrument in an oxygen-enriched atmosphere.
• make any unauthorized repairs or modications to this product, as it may
cause personal injury or damage to the unit.
SECTION 2
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

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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY BASE STATION (CONT.)
NOTE:
• The AC adapter power supply plug acts as a disconnect device for the Base
Station and therefore, the AC socket outlet must be installed (or located)
near the Base Station and must be easily accessible if the Base Station needs
to be unplugged. When correctly connected to power, the blue light on the
Base Station will be illuminated. After an instrument is docked, the blue
light above the screen will be illuminated. This may take several seconds.
If the blue light does not illuminate, check the power supply. Ensure that
the Base Station is connected properly and that the instrument is seated
correctly in the Base Station.
• Protection provided by this equipment may be impaired if used in a manner
not specied by Abbott Point of Care.
• The instrument and its peripherals are not listed by any authority with
respect to suitability for use in oxygen-enriched atmospheres.
• The Base Station must be on a at, level, horizontal surface such as a table
top. Falling equipment may cause injury. Always place the equipment on a
stable level surface in a location where it will not cause injury if dropped.
SECTION 2

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i-STAT ALINITY PRINTER
For best results, observe the following precautions when using the i-STAT
Alinity printer.
DO:
• use only a rechargeable battery pack purchased from Abbott Point of Care.
• use only the power adapter and supply provided with the i-STAT Alinity
printer kit.
• use an i-STAT Alinity printer when attempting to print from an i-STAT
Alinity instrument.
• check with authorities for local, state, and/or national requirements for
disposal.
DO NOT:
• operate the printer without paper.
• pull paper through the paper mechanism. Damage to the printer can result.
Use the paper feed button.
• allow the power supply to become a trip hazard.
• place the printer in an oxygen-enriched atmosphere.
• disturb the instrument or the printer until printing is complete, since this
will interrupt the printout. If printing is interrupted, realign the instrument
and the printer, or replace the instrument in the Base Station to resume
printing.
• place printers side by side. Doing so may cause instrument to printer
communication problems.
SECTION 2
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i-STAT Alinity — Quick Reference Guide Art: 731848-01 Rev. M Rev. Date: 25-Jul-2022
i-STAT ALINITY PRINTER (CONT.)
NOTE:
• The instrument and its peripherals are not listed by any authority with
respect to suitability for use in oxygen-enriched atmospheres.
• In the event of a battery leaking, do not allow any leakage to come into
contact with the skin or eyes. If contact has been made, wash the affected
area with copious amounts of water and seek medical advice.
• If a printout appears inconsistent with a patient’s clinical assessment, verify
that the correct patient record was selected (patient ID, date and time of
test, etc.). If the record is not correct, select the correct record and print.
If the printout still does not match the data in the instrument, the printer
needs service and the printed results must not be used. If another printer is
available, retry.
• Fluorescent light sources can cause interference with communications
sent to the i-STAT Alinity printer. When light from a uorescent source of
sufcient proximity or brightness has a direct path into the printer’s infrared
radiation (IR) window, the printer might fail to respond when records are
sent for printing over a serial (wired) connection to a Base Station.
SECTION 2
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SECTION 3
ANATOMY OF THE INSTRUMENT
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.