Naida™ CI M90 Sound Processor
Advanced Bionics, LLC · Model CI-5293-140
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of D-dimer protein in a clinical specimen.
Key tips
- ·When no category-specific guidance fits, default to the manufacturer's own service manual and the general troubleshooting method in the Engineer's Guide.
- ·Run an incoming and annual electrical safety test regardless of how niche the device is.
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.
- ·Follow the manufacturer's PM schedule
- ·Perform incoming and annual electrical safety testing per facility biomedical program
Technical Specs
- Storage Environment Temperature
- -20°C to 55°C
- Storage Environment Humidity
- 0 Percent (%) Relative Humidity to 95 Percent (%) Relative Humidity
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- No
- Single use
- No
- FDA distribution status
- In Commercial Distribution
- Device type (GMDN)
- D-dimer IVD, control
- FDA product classification
- Implant, cochlear
- Manufacturer support
- +1(661)362-1400 · xxx@xxx.xxx
Typical Location
Where this class of equipment is typically deployed - general reference, not this unit's own placement record.
- Varies by device - check the unit's own manual for facility placement guidance
Documents & Manuals
No documents available for this device yet.
Safety & Recalls
Synced live from the FDA openFDA API.
- RECALL
Behind-the-ear sound processer packaging label is different then included product.
- RECALL
The sound processors were loaded with the incorrect firmware.
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