User s Manual Battery Powered Driver. For tapping and inserting screws into varied bone densities.
Table of Contents Introduction Battery Powered Driver 2 Operating Instructions Assembly 3 Screw Insertion 4 Manual Use 5 Screw Removal 6 Blade Removal 6 Cleaning and Sterilization 7 Product Information Battery Powered Driver System 8 Synthes
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) Drive-lock nose cone Speed controls (2 forward plus reverse) Single-use, sterile battery pack attaches to hand piece Hex coupling Features Two insertion speeds for tapping and placing screws into varied bone densities One reverse speed for removing taps and screws Drive-lock mechanism for manual insertion or removal of taps and screws Easily connects to Synthes hex coupling screwdriver blades and taps 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. 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 2 Synthes Battery Powered Driver User s Manual
Operating Instructions 1 Connect battery pack to hand piece Instruments 05.000.007.01S Battery Pack, sterile 05.000.008 Hand Piece, for Battery Powered Driver Align the battery pack with the corresponding shape on the hand piece. Press the battery pack onto the hand piece until secure. 2 Insert blade into nose cone Insert the appropriate hex coupling screw driver blade or tap while pushing down on the nose cone. Release the nose cone, and verify that the blade or tap is locked in place. Synthes 3
Operating Instructions continued 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 disengage ment from the screwhead (Figure 1). High speed Low speed Reverse Gently rock the screwdriver once from side to side to release the blade from the head of the screw (Figure 2). Caution: To avoid screw breakage, manually back out a partially inserted screw one revolution before reattempting power insertion. Figure 1 Figure 2 4 Synthes Battery Powered Driver User s Manual
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 Synthes 5
Operating Instructions continued 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. 6 Synthes Battery Powered Driver User s Manual
Cleaning and Sterilization Cleaning Hand Piece (05.000.008) Note: Do not submerge or soak power equipment 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. 7. Visually inspect the hand piece. Repeat Steps 2 6 until no visible soil remains on the device. 8. Perform a final rinse using deionized or purified water for a minimum of two minutes. 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. 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. * Consult local laws regarding disposal. Batteries may be safely disposed of with hospital waste. Synthes 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 Graphic Case 305.840 Graphic Case for Battery Powered Driver (includes base, lid, and inserts) Hex Coupling Accessories StarDrive Screwdriver Blades, self-retaining 313.827 1.3 mm, short 313.825 1.3 mm, medium 313.837 1.5 mm, short 313.852 1.5 mm, medium 313.838 1.5 mm, long 313.847 2.0 mm, short 313.855 2.0 mm, medium 313.848 2.0 mm, long StarDrive Blade Cruciform Screwdriver Blades, self-retaining 313.917 1.3 mm 313.935 1.5 mm/2.0 mm, short 313.936 1.5 mm/2.0 mm, long 313.928 2.0 mm/2.4 mm 313.939 2.4 mm/3.0 mm Cruciform Screwdriver Blade 313.97 Holding Sleeve Cruciform Blade 8 Synthes Battery Powered Driver User s Manual
PlusDrive Screwdriver Blades, self-retaining 313.252 1.5 mm/2.0 mm, 96 mm 313.253 1.5 mm/2.0 mm, 76 mm 313.254 1.5 mm/2.0 mm, 52 mm 313.805 1.3 mm, 52 mm 313.806 1.3 mm, 76 mm Low Profile Neuro Cruciform Screwdriver Blades, self-retaining 313.931 short 313.932 medium MatrixNEURO Screwdriver Blades, self-retaining 03.503.016 short 03.503.017 medium MatrixMANDIBLE/MatrixThorax Screwdriver Blades, self-retaining 03.503.070 short 03.503.071 medium 03.503.072 long MatrixMIDFACE Screwdriver Blades, self-retaining 03.503.201 52 mm 03.503.202 76 mm 03.503.203 96 mm 311.060.01S 311.061.01S 311.062.01S 311.093.01S 311.094.01S 311.110.01S Self-Drilling Taps for 1.5 mm Resorbable Cortex Screws, sterile 4 mm stop 6 mm stop 3 mm stop 5 mm stop 8 mm stop adjustable stop (3 mm 8 mm) 351.034 4.5 mm Hexagonal Adjustable Screwdriver Blade, with spade point PlusDrive Blade Matrix Blade 311.063.01S 311.064.01S 311.065.01S 311.111.01S 311.067.01S 311.068.01S 311.069.01S 311.071.01S 311.072.01S 311.073.01S 311.112.01S Low Profile Neuro Cruciform Blade Self-Drilling Tap Self-Drilling Taps for 2.0 mm Resorbable Cortex Screws, sterile 4 mm stop 6 mm stop 8 mm stop adjustable stop (4 mm 8 mm) Self-Drilling Taps for 2.0 mm Resorbable Cortex Screws for 1.5 mm Resorbable Plates, sterile 4 mm stop 6 mm stop 8 mm stop Self-Drilling Taps for 2.5 mm Resorbable Emergency Screws, sterile 4 mm stop 6 mm stop 8 mm stop adjustable stop (4 mm 8 mm) Synthes 9
Synthes CMF 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610) 251-9056 Synthes (Canada) Ltd. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 www.synthes.com 2005 Synthes, Inc. or its affiliates. All rights reserved. PlusDrive and Synthes are trademarks of Synthes, Inc. or its affiliates. STERRAD is a trademark of Advanced Sterilization Products. Printed in U.S.A. 11/10 J5594-D