Alere Afinion™ AS100
Abbott Diagnostics Technologies AS · Model 1115390
Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of care testing, designed to analyze the Afinion Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion Analyzer to a laboratory information system or another electronic journal system. Alere Afinion AS100 Analyzer System, consisting of Alere Afinion AS100 Analyzer with Alere Afinion Data Connectivity Converter (ADCC), Afinion Test Cartridges and Afinion Controls is for in vitro di.
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.
Key tips
- ·Run QC controls before trusting any repair - an analyzer that passes self-test can still report clinically wrong results.
- ·Rule out a reagent lot change before opening the instrument - it can look exactly like a hardware fault.
- ·Centrifuge rotors have a hard retirement age/cycle limit regardless of visible condition - don't eyeball it.
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.
PM Checklist
Preventive-maintenance tasks typical of this equipment class. Perform to the manufacturer's procedure and your facility's policy - this is general reference, not a schedule for this specific unit.
- ·Daily QC controls run and reviewed
- ·Calibration verification per assay
- ·Routine cleaning and decontamination
- ·Scheduled reagent-path and pump-tubing maintenance
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
- 15°C to 32°C
- Storage Environment Temperature
- -40°C to 70°C
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- Prescription use
- Rx only
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- Multiple clinical chemistry analyser IVD, point-of-care
- FDA product classification
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Central / core laboratory
- Point-of-care testing stations
- Blood bank
- Microbiology lab
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
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