Indications
The Fusion™ Instrument system includes manual surgical instruments intended to manipulate tissue.
Precautions
The methods of use of these instruments are to be determined by the user’s experience and training.
Do not use these instruments for any action for which the device was not intended such as hammering, prying, or lifting.
These instruments should be handled with care, placed in the correct location within the tray, cleaned after each use, and stored in a dry environment.
To avoid injury, the instrument should be carefully examined prior to each use. A damaged instrument should not be used.
If there is any doubt or uncertainty concerning the proper use of these instruments please contact Pioneer Surgical Technology Customer Service for instructions. Refer to implant specific technique guides, where applicable, for additional information.
This system has not been evaluated for safety and compatibility in the MR environment. This system has not been tested for heating or migration in the MR environment.
See product specific surgical technique manual and package insert for complete instructions and labeling limitations.
