4
17. Disposable blades and burs are supplied sterile and are for single-use
only. Do not resterilize or reuse. The ability to effectively clean and
re-sterilize these single use devices has not been established and
subsequent re-use may adversely affect the performance, safety and/or
sterility of the devices.
1.5.2 Precautions
1. United States Federal law restricts sale of this device to or on
the order of a physician.
2. This device should only be used in compliance with its intended use.
3. Handle all equipment carefully. If any equipment is dropped or damaged in
any way, return it immediately for service.
4. Use only associated ConMed Linvatec approved equipment and accessories.
Using unapproved accessories may result in improper operation, and may
result in non-compliance to medical standards.
5. The warranty becomes void and the manufacturer is not liable for direct or
resulting damage if:
• The device or the accessories are improperly used, prepared or maintained;
• The instructions in the manual are not adhered to;
• Non-authorized persons perform repairs, adjustments or alterations to
the device or accessories.
6. There are no user-serviceable parts inside. No modification of this
equipment is allowed.
7. Prior to each use, perform the following:
• Ensure all accessories are correctly and completely attached. (Refer to
section “2.2 Assembly/Installation Instructions”).
• Perform the required Preoperative Functional Tests for the equipment
and accessories. (Refer to section “2.4 Preoperative Functional
Test”).
8. Clean and sterilize all the equipment and associated accessories according to
instructions for use. (Refer to section “3.1 Cleaning Information” and
section “3.2 Sterilization Information”).
9. Handpieces are factory sealed. Do not disassemble or lubricate, as
this may void the warranty.
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