Abbott i-STAT 1

Preventive Maintenance Procedure

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Asset Type

Blood Gas Analyzer

Manufacturer

Abbott

Model

i-STAT 1

Manual Reference

Abbott Point of Care i-STAT 1 System Manual, 014331-00 Rev. 66A, updated March 2025; Thermal Probe Check, 714376-00AB; and current Abbott technical bulletins. Verify the locally applicable revision, analyzer configuration, test complexity, and laboratory quality plan before service.

Manufacturer Recommendation / AEM Status

Abbott recommends verification of the analyzer thermal probes every six months. The check is performed with an external i-STAT Electronic Simulator, and the displayed thermal difference is acceptable from -0.1 through +0.1, inclusive. Repeat an out-of-range, unavailable, or thermal-code result once; contact Abbott Point of Care Technical Support if the repeat check fails.

Electronic quality control is an operational laboratory requirement, not merely an annual biomedical check. For waived testing, Abbott directs each analyzer to be checked with the internal or external Electronic Simulator once on each day of use. The internal simulator normally activates the first time the analyzer is used and after every 24 hours of use. A new, repaired, or replacement analyzer must be checked before use, and an external simulator check is required after analyzer software updates.

This PM supports the physical analyzer and configured downloader/recharger. Cartridge receipt, storage, liquid controls, operator competency, proficiency testing, and the laboratory's IQCP or other quality plan remain under the responsible laboratory/POCT program. Do not replace or relax those requirements through an AEM decision. Analyzer disassembly and repair beyond published operator procedures require appropriately trained or authorized personnel.

What This PM Procedure Covers

Required Tools and Equipment

Step-by-Step PM Procedure

1. Verify Identity and Configuration

Action: Record asset tag, analyzer serial number, exact i-STAT 1 configuration, wireless capability, battery type, downloader/recharger model and serial number when included, software application version, CLEW version, customization profile, location, and responsible POCT program.

Expected outcome: The analyzer and all maintained accessories match the CMMS record and applicable Abbott documentation.

2. Review Service and Quality History

Action: Review battery, cartridge-port, contact-pin, keypad, display, barcode, simulator, thermal, environmental, connectivity, coded-message, drop, spill, and repair history. Confirm that daily electronic-QC, software-update, and six-month thermal-probe records are available to the responsible laboratory.

Expected outcome: Recurrent problems and overdue manufacturer-required quality activities are identified before testing.

3. Remove the Analyzer From Clinical Testing

Action: Coordinate with the POCT program, preserve required result records, and label the analyzer as under maintenance. Remove and discard any cartridge using the laboratory's biohazard procedure. Do not use patient material for PM.

Expected outcome: The analyzer cannot be used for patient testing during maintenance and protected information remains controlled.

4. Inspect the Analyzer Exterior

Action: Inspect the case, display window and screen seam, keypad, scan window, battery door, fasteners, labels, serial marking, cartridge port, and mating surfaces. Look for cracks, sharp edges, looseness, discoloration, liquid evidence, corrosion, impact damage, or unauthorized modification.

Expected outcome: The enclosure is complete, legible, secure, and free of contamination or damage that could affect safe operation.

5. Inspect the Cartridge Port and Contact Pins

Action: With the analyzer off and battery removed, illuminate the cartridge port without inserting metal tools. Inspect the connector area for dried material, debris, bent or contaminated pins, and evidence of fluid entry. Use Abbott's Contact Pin Cleaning Kit only when indicated and follow its current instructions exactly.

Expected outcome: The port is dry and unobstructed; pins appear aligned and clean. Damage or contamination not corrected by the approved process requires escalation.

6. Inspect the Battery System

Action: Identify the installed disposable or rechargeable battery configuration. Inspect batteries, contacts, compartment, door, latch, and gasket area for leakage, swelling, corrosion, contamination, heat damage, or incorrect parts. Remove batteries for extended storage as Abbott directs.

Expected outcome: Approved batteries and the compartment are clean, secure, undamaged, and suitable for continued use.

7. Inspect the Downloader/Recharger and Accessories

Action: When included, inspect the downloader or downloader/recharger, cradle contacts, infrared window, network/USB cables, power supply, mains cord, plug, labels, case, and strain reliefs. Confirm the analyzer seats securely. Inspect the Electronic Simulator body, gold contacts, label, serial number, and protective cap without touching its contacts.

Expected outcome: Accessories are correct, intact, clean, and securely connected, with no exposed conductors, damaged contacts, or fluid intrusion.

8. Clean and Decontaminate

Action: Wear gloves. Clean the display and case using an Abbott-approved method. Avoid excess fluid at the display seam, cartridge port, battery compartment, and connectors. Wipe the case with water-moistened gauze after the approved chemical where instructed, then dry completely. Do not immerse, autoclave, irradiate, gas-sterilize, or use an unapproved cleaner.

Expected outcome: The analyzer and downloader are visibly clean, dry, and undamaged with no fluid in an opening or compartment.

9. Verify Power-Up, Display, Keypad, and Audio

Action: Install approved batteries and power on the analyzer. Confirm a normal startup without unresolved coded messages. Check the display for missing segments or unreadable areas; operate each keypad control used by the menus and verify audible feedback where configured.

Expected outcome: Startup completes normally and the display, keypad, and audio support unambiguous operation.

10. Verify Identification and Barcode Entry

Action: In an approved administrative or test workflow, scan a known readable non-patient barcode and compare the displayed entry. Verify manual numeric entry and correction controls without creating a patient result.

Expected outcome: The scanner and keypad enter the complete identifier accurately and consistently.

11. Verify Date, Time, Software, and Customization

Action: Confirm date and time, software application version, CLEW version, language/units, operator and patient identification settings, lockouts, and communication configuration against the POCT program's approved profile. Perform software updates only when supplied and authorized by Abbott; check the analyzer with the external simulator after any update.

Expected outcome: Time, software, and controlled settings match the approved configuration and no unauthorized changes are present.

12. Perform the External Electronic Simulator Test

Action: Allow the analyzer and simulator to stabilize together when their prior storage temperatures differed by more than 3 °C (5 °F). From the Administration Menu select Quality Tests → Simulator, enter required identification and the simulator serial number, then insert the simulator with gold contacts facing up and forward. Do not remove it while locked.

Expected outcome: The analyzer reports PASS. A failed simulator test is repeated according to the manual and escalated if it fails again.

13. Verify the Thermal Probes

Action: When the simulator result is displayed, press the period key to show the thermal difference. Record the value. If the result is below -0.1, above +0.1, displays “--.--,” or reports a FAIL with a “t” quality-check code, repeat the procedure while minimizing simulator handling. Contact Abbott support if the repeat result fails.

Expected outcome: The recorded thermal difference is -0.1 to +0.1 inclusive, with no thermal quality-check code.

14. Verify the Downloader/Recharger and Communication

Action: When configured, place the analyzer in the correct downloader/recharger and verify stable seating, charge indication for the rechargeable configuration, and data transfer to the approved data manager. Confirm successful analyzer identification and transfer using non-patient or approved test data; do not alter network settings without authorization.

Expected outcome: The analyzer docks and charges where applicable, and required communication completes without an error or missing record.

15. Complete Configuration-Appropriate Electrical Safety

Action: Treat the handheld as battery-powered equipment. If the mains-powered downloader/recharger is included in the PM scope, inspect and test that accessory according to its exact label, power-supply construction, and the facility's adopted electrical-safety standard. Do not apply mains tests directly to the handheld or invent an Abbott leakage limit.

Expected outcome: The handheld is documented as battery powered, and any applicable mains accessory passes the facility's configuration-specific criteria or is documented separately.

16. Restore and Document

Action: Remove test identifiers/data according to policy, reinstall approved batteries, replace the simulator cap, restore connections and customization, and repeat startup/docking checks. Record inspection, cleaning, battery, software, simulator PASS, thermal value, communication, electrical result or N/A, corrective work, and final disposition. Notify the POCT program of any quality-system gap.

Expected outcome: The analyzer is complete, clean, correctly configured, traceable, and either returned to service with required quality records or clearly removed from service.

Electrical Safety Testing

The i-STAT 1 handheld operates from batteries and is not connected directly to mains during testing, so routine line-powered electrical-safety measurements are not applicable to the handheld itself. A configured downloader/recharger uses an external mains power supply. When that accessory is part of the maintained asset and facility policy requires electrical testing, verify its exact construction and test only the applicable protective-earth, enclosure/touch-current, or visual-inspection criteria under the facility's adopted standard. Record nonapplicable measurements as N/A rather than applying unsupported limits.

Pass / Fail Criteria

Pass

Remove From Service

Copy/Paste CMMS Work Order Procedure

This equipment supports regulated point-of-care laboratory testing. Coordinate return to patient testing with the responsible laboratory or POCT program and follow the current Abbott instructions, cartridge information, quality plan, and applicable regulatory requirements.

Sources

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