ENDOTINE Forehead Instrument Kit Instructions for Use

ENGLISH

ENDOTINE Forehead™ Instrument Kit ENDOTINE Forehead™ Instrument Kit CFD-010-4320, Contains: Part Number

Part Name

CFD-010-4313

Drill Bits (2)

CFD-010-4305

Insertion Tool

HWS-010-1500

Sterilization Tray

DESCRIPTION The ENDOTINE Forehead™ Instrument Kit consists of a reusable sterilization tray, insertion tool and drill bits used in the installation of the MicroAire ENDOTINE and ULTRATINE Forehead™ Devices. This kit is not supplied sterile. INDICATIONS The ENDOTINE Forehead™ Instrument Kit is intended for use in subperiosteal browplasty surgery, specifically for use only with the ENDOTINE or ULTRATINE Forehead™ Device. CONTRAINDICATIONS 1. Situations where internal fixation is otherwise contraindicated (e.g. infection). 2. Insufficient thickness or quality of cranial bone, which would impair secure fixation and place patient at risk. WARNINGS 1. The enclosed drill bits are designed to be of appropriate depth for adult patients when used to create a hole in the cranium slightly above or medial to the temporal fusion line and anterior to the coronal suture. However, the surgeon should note any penetration beyond the inner table of the cranium, and if observed, should seek follow-up and neurosurgical consultation as appropriate. 2. Inspect all instruments in the kit for damage before use. Do not attempt to repair or sharpen instruments. PRECAUTIONS 1. High speed drilling (approximate 1000 rpm and greater) and repeat drilling may create holes that are wider than intended for a tight grip of the ENDOTINE or ULTRATINE Forehead™ Device. Single pass, low speed drilling reduces the occurrence of wider holes.

INSTRUCTIONS FOR USE 1. Refer to ENDOTINE Forehead™ Instructions for Use (IFU) for use of insertion tool, the drill bit and implantation of device. 2. Clean and sterilize this Instrument Kit prior to use. Steam sterilization is recommended using the Association for the Advancement of Medical Instrumentation (ANSI/AAMI ST46:2002) Guideline, “Good Hospital Practice: Steam Sterilization and Sterility Assurance.” Specifically, cleaning and sterilization instructions for the ENDOTINE Forehead™ Instrument Kit are recommended below. 3. Visually inspect the insertion tool, drill bits and sterilization tray for corrosion, cracks or damage after each sterilization and prior to use. CLEANING Cleaning Instructions for Tray, Drill Bits and Insertion Instrument 1. Rinse individual components with tap water for two (2) minutes while brushing with a soft bristled brush to remove all visible debris. 2. Place individual components into an enzymatic detergent bath for five (5) minutes (i.e. ENZOL® or equivalent). 3. Scrub individual components with a soft bristled cleaning brush to remove any remaining debris. 4. Rinse individual components for an additional two (2) minutes using tap water. 5. Visually inspect to verify that all visible debris has been removed. STERILIZATION The ENDOTINE Forehead™ Instrument Kit and instruments are NOT PRE-STERILIZED and must be sterilized prior to each patient use. The complete kit (including stainless steel instruments) is validated for the following two (2) sterilization methods: a. Gravity displacement steam sterilization with an exposure time1 of 30 minutes at 250°F (121°C). b. Pre-vacuum steam sterilization with an exposure time1 of 4 minutes at 270°F (132°C). Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the order of a physician. Warranty: The ENDOTINE Forehead™ Instrument Kit (CFD‑010‑4320) is warranted for 1 year against defects in materials and workmanship. 1 “Exposure time: The period during which items are exposed to

saturated steam at the specified temperature.” (ANSI/AAMI ST46:2002)

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