i-STAT
ABBOTT POINT OF CARE INC. · Model 03P75-56
I-Stat 1 Wireless Analyzer.
Intended use: A portable, electrically-powered instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro detection of multiple clinical chemistry analytes in a clinical specimen, using one or more technology(ies) [e.g., microfluidics, electrometry, spectrophotometry, colorimetry, fluorimetry, radiometry, chemiluminescence]. Analytes detected may include electrolytes, specific proteins, clinical chemistry substrates (e.g., lipid profile), liver and/or cardiac function test analytes, and/or enzymes.
Typical Failure Modes
Compiled for this model from its own documentation and established engineering knowledge for this equipment class - not from a verified service record. Confirm against the manufacturer's service manual.
Result / QC failure
HighSymptoms: Result flagged or biased, QC control out of range, strip / cartridge error code.
Root cause: Expired or mishandled strips / cartridges, a temperature / hematocrit interference, or an optics / electrode fault.
Strip / cartridge port fault
MediumSymptoms: Strip not detected, error on insertion, intermittent contact.
Root cause: Contaminated or worn strip-port contacts / optics.
Will not power on / battery fault
MediumSymptoms: Dead unit, short battery life, will not charge.
Root cause: Depleted or aged battery.
Barcode / connectivity fault
LowSymptoms: Operator / lot barcode will not scan, results not sent to the docking / LIS.
Root cause: Barcode reader or the docking-station / wireless link.
Display / button fault
LowSymptoms: Missing segments, unresponsive buttons.
Root cause: Display or keypad fault.
Serviceable Parts & Consumables
Serviceable items for this model, compiled from its documentation and engineering knowledge for this equipment class. Service class and relative cost are estimates, not manufacturer figures; no part numbers are given. Confirm intervals and pricing against the manufacturer.
Test strips / cartridges
Class Frequent wear itemRel. cost $$R&R Easy
QC control solutions
Class Frequent wear itemRel. cost $R&R Easy
Battery
Class Frequent wear itemRel. cost $R&R Easy
Strip-port contacts / optics module
Class Periodic replacementRel. cost $$R&R Moderate
Docking station / barcode reader
Class Periodic replacementRel. cost $$R&R Fairly easy
| Part | Service class | Relative cost | R&R difficulty |
|---|---|---|---|
| Test strips / cartridges | Frequent wear item | $$ | Easy |
| QC control solutions | Frequent wear item | $ | Easy |
| Battery | Frequent wear item | $ | Easy |
| Strip-port contacts / optics module | Periodic replacement | $$ | Moderate |
| Docking station / barcode reader | Periodic replacement | $$ | Fairly easy |
Relative cost: $ lowest · $$$$ highest service-part cost for this equipment class. Not a price.
Troubleshooting Approach
A starting sequence for this model, compiled from its documentation and engineering knowledge for this equipment class. Follow the manufacturer's service documentation for the actual procedure.
Symptom: Result or QC failure
- Repeat with a fresh strip / cartridge from a correctly stored, in-date vial.
- Run the QC control solutions at each level.
- Confirm the meter is coded / calibrated to the current strip lot.
- Clean the strip port per the manual.
- Quarantine the strip lot if QC fails; replace the meter if QC still fails with good strips.
Symptom: Strip not detected
- Inspect and clean the strip-port contacts / optics.
- Try several strips from a fresh vial.
- Check for physical damage to the port.
- Replace the battery.
- Replace the meter if it will not read good strips.
Technical Specs
- Handling Environment Temperature
- -10°C to 46°C
- Storage Environment Temperature
- 16°C to 30°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Multiple clinical chemistry analyser IVD, point-of-care
- FDA product classification
- GLUCOSE OXIDASE, GLUCOSE
- Manufacturer support
- +1(800)366-8020 · techsvc@apoc.abbott.com
Documents & Manuals
No documents available for this device yet.
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