Use Instructions

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8. MRI Compatibility
The CTE implant is expected to be MRI conditional. (Pending completion of MRI safety testing).
WARNING: Pending completion of MRI safety testing.
9. GENERAL WARNINGS AND PRECAUTIONS
9.1. CTE
WARNING: Do not use the CTE implant or other sterile packaged components if the package is
opened or damaged. This could mean the device is no longer sterile. Use of non-sterile implants
or components might result in patient infection, injury, or death.
CAUTION: Do not apply electrocautery directly to or across the CTE implant as this could cause
damage to the device.
WARNING: The CTE implant may heat up during an MRI procedure causing pain or tissue
damage.
WARNING: Do not apply ionizing radiation to or near the CTE implant as this could damage the
implant.
9.2. Surgical and Home Base Stations and Accessories (including Bar Code Scanners, Laptops,
and cables)
WARNING: Use only cables and accessories supplied by Canary Medical. Use of other cables and
accessories may result in increased emissions or decreased immunity of the CTE with CHIRP
System.
WARNING: Plug Base Stations and accessories into standard 110V wall outlets only. Attempting
to connect these items to a non-standard electricity source could cause injury or cause damage
to the equipment.
WARNING: Do not stack the Base Stations and accessories or use them adjacent to other
electrical equipment.
WARNING: Do not immerse the Base Station or accessories in water. Electric shock could result.
CAUTION: Do not use electrical converters with the Base Stations or accessories. They have not
been tested for this application.
Physician Instructions for Use
DRAFT