BATTERY POWERED DRIVER

BATTERY POWERED DRIVER For inserting screws into varied bone densities USERS MANUAL Table of Contents Introduction Battery Powered Driver Opera...
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BATTERY POWERED DRIVER For inserting screws into varied bone densities

USERS MANUAL

Table of Contents

Introduction

Battery Powered Driver

Operating Instructions

Assembly3

Product Information

2

Screw Insertion

4

Manual Use

5

Screw Removal

6

Blade Removal

6

Cleaning and Sterilization

7

Battery Powered Driver System

8

Battery Powered Driver  DePuy Synthes CMF

BATTERY POWERED DRIVER

Hand Piece (05.000.008) • Forward speeds: 225 and 295 rpm • Reverse speed: 295 rpm • Maximum torque: ≈ 0.46 Nm (65 oz-in) • Weight: 311 grams (10 oz) • Operating temperature: 15°–35°C (59°–95°F) Speed controls (2 forward plus reverse)

Drive-lock nose cone

Single-use, sterile battery pack attaches to hand piece

Hex coupling Features • Two insertion speeds for placing screws into varied bone densities • One reverse speed for removing screws • Drive-lock mechanism for manual insertion or removal of screws • Easily connects to DePuy Synthes hex coupling screwdriver blades • Hand piece is autoclavable

Single-use Battery Pack, sterile (05.000.007.01S) No sterilization is required for the single-use battery pack. The battery pack is sterile-packed and precharged.

Important: Do NOT sterilize. Do NOT charge.

STERRAD® Battery (05.000.010) STERRAD Battery is provided non-sterile.

Important: Use STERRAD sterilization process only prior to use. Do not charge or autoclave.

Complies with standards: UL2601-1, UL60601, IEC60601-1, EN60601-1-2, EN55022, EN55014-2, EN61000-4-2, EN61000-4-3, CAN/CSA C22.2 No. 601-M90

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DePuy Synthes CMF Battery Powered Driver

Users Manual

OPERATINg INSTRUCTIONS

1 Connect battery pack to hand piece Instruments 05.000.007.01S or 05.000.010

Battery Pack, sterile

05.000.008

Hand Piece, for Battery Powered Driver

STERRAD Battery

Align the battery pack with the corresponding shape on the hand piece. Press the battery pack onto the hand piece until secure.

Note: If Hand Piece powers on without pressing power button, then disconnect Battery Pack and use a different Battery Powered Driver Hand Piece.

2 Insert blade into nose cone Insert the appropriate hex coupling screwdriver blade while pushing down on the nose cone. Release the nose cone, and verify that the blade is locked in place.

Battery Powered Driver

Users Manual

DePuy Synthes CMF

3

Operating Instructions

3 Screw insertion Choose the appropriate speed to insert screws. Load screw and press appropriate power button to insert. Alignment When placing screws, maintain vertical alignment of the screwdriver and screw to prevent disengagement from the screwhead (Figure 1).

High speed

gently rock the screwdriver once from side to side to release the blade from the head of the screw (Figure 2).

Caution: In order to avoid breakage of a partially inserted screw, manually back out the screw one revolution before reattempting power insertion. Note: If Hand Piece fails to turn on, check if drivelock mechanism is engaged (see Figure 3 on the following page). If Hand Piece still fails to turn on, then disconnect battery pack and use a different Battery Powered Driver Hand Piece.

Figure 1

Figure 2

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DePuy Synthes CMF Battery Powered Driver

Users Manual

Low speed

Reverse

Operating Instructions

Manual use Maintain the screw/blade engagement in situ and turn the nose cone to the closed-lock position. The drive-lock mechanism is engaged when the indicator is aligned with the closed-lock symbol on the nose cone (Figure 3). The driver can now be used manually to complete final seating of the screw. Return to power If the drive-lock mechanism is engaged (manual mode), turn the nose cone back to the unlock position (Figure 4) to resume power insertion.

Figure 3

Figure 4

Battery Powered Driver

Users Manual

DePuy Synthes CMF

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Operating Instructions

4 Screw removal Manual removal To remove a screw manually, the drive-lock mechanism must be engaged. Prior to engaging the blade in the screw, turn the nose cone to the lock position. Manual removal can now be achieved. Power removal To remove a screw with power, turn the nose cone to the unlock position and depress the orange reverse button.

5 Blade removal To remove the screwdriver blade from the hand piece, push down on the nose cone and firmly pull the blade out to release.

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DePuy Synthes CMF Battery Powered Driver

Users Manual

Cleaning and Sterilization

Cleaning Hand Piece (05.000.008)

7. Visually inspect the hand piece. Repeat Steps 2–6 until no visible soil remains on the device.

Note: Do not submerge or soak power equipment

8. Perform a final rinse using deionized or purified water for a minimum of two minutes.

in aqueous solutions! Manual clean only. Do not use a brush, sharp object or pressurized water to clean the contact plate. Do not soak, immerse or clean the hand piece in washer/sterilizer. Do not expose to saline solution. Saline will shorten instrument life. Do not lubricate or oil the hand piece. 1. Remove the battery pack from the hand piece. 2. Rinse the hand piece under running cold tap water for a minimum of three minutes. Use a soft, lint free cloth and/ or soft-bristled brush to assist in the removal of gross soil and debris. Manipulate all moving parts under running cold tap water to loosen and remove gross debris. 3. Spray the hand piece using a neutral pH enzymatic solution or foam spray and let it sit for three minutes. Follow the enzymatic detergent manufacturer’s instructions for use for correct temperature, water quality (i.e., pH, hardness) and concentration/dilution. 4. Rinse the hand piece with cold tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush lumens, channels and other hard to reach areas. 5. Clean the hand piece manually under running warm water using a neutral enzymatic detergent for a minimum of five minutes. Use a soft-bristled brush and/or soft, lint free cloth to remove all visible soil and debris. Actuate the drive-lock mechanism for thorough cleaning. Follow the enzymatic detergent manufacturer’s instructions for use for correct temperature, water quality (i.e., pH, hardness) and concentration/dilution. 6. Rinse the hand piece using cool to lukewarm running tap water for a minimum of two minutes. Use a syringe, pipette or water jet to flush lumens and channels. Actuate the drive-lock mechanism and rinse thoroughly under running water.

9. Dry the hand piece using a soft, lint free cloth, or clean compressed air. Minimum Sterilization Requirements Prevacuum Steam sterilize at 132°C (270°F) for 4 minutes. Minimum dry time: 20 minutes.

Important: Do NOT use STERRAD Sterilization System. Allow to cool to room temperature before use. Sterilization times represent exposure times only, not total cycle times. Battery Pack, sterile (05.000.007.01S) Lithium* Battery pack is for single use only. Dispose after use.*

Note: For more information, please see package insert. Single-use battery pack is provided sterile unless package is opened or damaged. Important: Do NOT sterilize. Do NOT recharge.

Sterrad Battery (05.000.010) Lithium*

Note: For more information, please see package insert. Sterrad battery is provided non-sterile. Use Sterrad sterilization process only prior to use. Do not charge or autoclave.

* Consult local laws regarding disposal. Batteries may be safely disposed of with hospital waste.

Battery Powered Driver  Users Manual  DePuy Synthes CMF    7

BATTERY POWERED DRIVER SYSTEM

Battery Powered Driver 05.000.007.01S Battery Pack, sterile, for Battery Powered Driver 05.000.008 Hand Piece, for Battery Powered Driver 05.000.010 STERRAD Battery, for Battery Powered Driver

Hex Coupling Accessories

313.917 313.935 313.936 313.928 313.939

Cruciform Screwdriver Blades, self-retaining 1.3 mm 1.5 mm/2.0 mm, short 1.5 mm/2.0 mm, long 2.0 mm/2.4 mm

313.97

2.4 mm/3.0 mm Cruciform Screwdriver Blade Holding Sleeve

313.252 313.253 313.254 313.805 313.806

PlusDrive Screwdriver Blades, self-retaining 1.5 mm/2.0 mm, 96 mm 1.5 mm/2.0 mm, 76 mm 1.5 mm/2.0 mm, 52 mm 1.3 mm, 52 mm 1.3 mm, 76 mm

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DePuy Synthes CMF Battery Powered Driver

Users Manual

Cruciform Blade

PlusDrive Blade

Battery Powered Driver System

313.931 313.932

Low Profile Neuro Cruciform Screwdriver Blades, self-retaining short medium

03.503.016 03.503.017

MatrixNEURO Screwdriver Blades, self-retaining short medium

03.503.070 03.503.071 03.503.072

MatrixMANDIBLE/MatrixThorax Screwdriver Blades, self-retaining short medium long

03.503.201 03.503.202 03.503.203

MatrixMIDFACE Screwdriver Blades, self-retaining 52 mm 76 mm 96 mm

Low Profile Neuro Cruciform Blade

Matrix Blade

Battery Powered Driver

Users Manual

DePuy Synthes CMF

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Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed. WARNING: In the USA, this product has labeling limitations. See package insert for complete information. CAUTION: USA Law restricts these devices to sale by or on the order of a physician. Not all products are currently available in all markets.

DePuy Synthes CMF 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322

Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185

www.depuysynthes.com

© DePuy Synthes CMF, a division of DOI 2013. All rights reserved. J5594-E 11/13