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Integra Ti6 Gebrauchsanweisung Seite 7

Internal fixation system
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  • DEUTSCH, seite 73
Maintaining Device Effectiveness
1. The surgeon should have specific training, experience, and thorough familiarity with the use of cannulated,
non-cannulated, headless, and snap-off screws.
2. The surgeon must exercise reasonable judgment when deciding which screw type to use for specific indications.
3. The Ti6 screws are not intended to endure excessive abnormal functional stresses.
4. All Ti6 Internal Fixation System screws and instrumentation may be required for each surgery. Failure to use
dedicated, unique Integra instruments for every step of the implantation technique may compromise the integrity
of the implanted device, leading to premature device failure and subsequent patient injury. Failed devices may
require re-operation and removal.
5. Carefully inspect the screws prior to use. Inspect the instruments before and after each procedure to assure they
are in proper operating condition. Instruments which are faulty, damaged or suspect should not be used.
6. Integra recommends the use of Integra products in a sterile environment.
7. For best results and to ensure proper working condition, after cleaning the Ratchet Handle (FS1006) a non-
silicone lubricant should be used per the manufacturer's instructions.
Pre-Operative, Intraoperative, and Post-Operative Care Instructions
Intraoperative care and directions for use are provided in the Surgical Technique, LC-04-5022-0003. Pre-operative
and post-operative care is to be specified by the surgeon's customary care.
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