Platinum Series™ Sound Processor
Advanced Bionics, LLC · Model AB-7250LP
Platinum Series™ Sound Processor
Intended use: An external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.
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
- Handling Environment Atmospheric Pressure
- 70 KiloPascal to 106 KiloPascal
- 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
- Not in Commercial Distribution
- Device type (GMDN)
- Cochlear implant/auditory brainstem implant sound processor
- 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
The sound processors were loaded with the incorrect firmware.
- RECALL
Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device. Potential clinical symptoms include: -No lock -Intermittent lock -Implant locks, but cann
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