Table of Contents
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Table of Contents
Summary of Contents for Osteomed PINNACLE
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Page 3: Table Of Contents
Table of Contents System Components Driver Battery Sterilization Trays Drills and Driver Stems System Overview Description/Indications/Contraindications/Warnings Operating Instructions 7-12 Operating Instructions 7-10 Cleaning Sterility Pinnacle Driver Overview Pinnacle Driver Instructions Pinnacle Driver Battery Pack Disposal Pinnacle Driver Technical Specifications... -
Page 4: System Components
System Components 110-1000-SP Replacement Battery, Sterile 110-1001 Pinnacle Battery Powered Screw Driver 110-1000-SP-02 Replacement Battery, Sterile, 2-Pack 110-1011 – Pinnacle Sterilization Tray, 1BPS 110-1012 – Pinnacle Sterilization Tray, 2BPS Page 4 osteomed.com... -
Page 5: System Components
6mm STOP 111-1660 111-1661 8mm STOP 111-1680 111-1681* * Indicates that driver stem or twist drill is shown TOTAL LENGTHS: SHORT EXTENDED 4mm STOP 42mm 78mm 5mm STOP 43mm 79mm 6mm STOP 44mm 80mm 8mm STOP 46mm 82mm Page 5 osteomed.com... - Page 6 If the device becomes too warm to hold comfortably during normal operation, discontinue use of the device. • Do not use the Pinnacle Driver in poor quality bone. Use of the Pinnacle Driver to insert screws in soft bone or diseased bone may result in stripping of the bone after full insertion.
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Page 7: Driver
Indicates Pinnacle Driver is powered, Blue DRILL operational, and in DRILL mode Flashing Indicates Pinnacle Driver is powered, but FAULT not functioning properly. If mode switch immediately illuminates a flashing red, remove the battery and replace with a new, unused battery and repeat battery insertion. -
Page 8: Operating Instructions
Use caution when inserting or changing accessories to avoid activation of the buttons. Note: Only OsteoMed Hex Shank Accessories may be used with the driver. It will be operational if the accessory is inserted before or after battery insertion. - Page 9 Operating Instructions (Cont.) Position the screw in the desired location on the bone and push the forward button. The Pinnacle Driver will rapidly insert the screw and the torque limiting software will halt motor operation when the screw is fully seated. Release pressure from the forward button and gently rock the hand piece from side to side to disengage the driver stem tip from the fully seated screw head.
- Page 10 Alternatively, the hand piece can be changed to DRIVE mode by removing and then re-inserting the battery. To remove the OsteoMed Hex Shank Accessory, pull back on the collet and hold depressed while pulling the accessory away from the handpiece.
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Page 11: Cleaning
Compliance is required with the equipment manufacturer’s user instructions (manual and/or automated cleaning, etc.) and recommendations for chemical detergents. • Automated Cleaning may be performed with Pinnacle Driver and OSTEOMED Hex Shank Accessories inside the Pinnacle Sterilization Case or out of the Pinnacle Sterilization Case. Automated Cleaning Method... -
Page 12: Sterility
(autoclaving). • Sterilization of the Pinnacle Driver can be achieved wrapped by itself (no case), or within an Aesculap container. Sterilization of the OSTEOMED Hex Shank Accessories can be achieved inside the Pinnacle organizational tray inside an Aesculap or other cleared containers. -
Page 13: Pinnacle Driver Overview
Pinnacle Driver Battery Overview The OSTEOMED Pinnacle Driver battery (p/n 110-1000) is a sterile, single use battery provided to power the Pinnacle Driver. The battery is provided sterile packaged in 1-pack (p/n 110-1000-SP) or 2-pack (110-1000-SP-02) configurations. This battery is intended for use solely with the Pinnacle Driver (p/n 110-1001) provided by OSTEOMED. -
Page 14: Pinnacle Driver Instructions
Pinnacle Driver Battery Instructions After removing the plastic tray from the black shelf box, use the “Peel Here” corner to remove the Tyvek lid. ® Bend back the ribbed corner of the tray with one hand and pull back the corresponding corner of the plastic lid slowly. -
Page 15: Pinnacle Driver Battery Pack Disposal
Pinnacle Driver Battery Pack Disposal • Observe the general environmental regulations applicable to battery disposal. Do not attempt to recharge a used battery. • Always follow local regulations for the disposal of Lithium metal battery packs and electronics. • Do not discard batteries in regular trash; they should be recycled properly. - Page 16 Pinnacle Ordering Information Pinnacle Driver: 110-1001 Pinnacle Single Sterilization Tray: 110-1011 Single Sterile Battery Pack: 110-1000-SP Pinnacle Double Sterilization Tray: 110-1012 Double Sterile Battery Pack: 110-1000-SP-02 Hex Shank Driver Stems: 114-XXXX Hex Shank Twist Drills: 111-XXXX OsteoMed Products DuraKnife OsteoMed Mesh...
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