90° Screwdriver. Instructions for disassembly, cleaning
Contents
1. Attach the appropriate Screwholder Insert to the coupling on the Screwholder 2 Press the head of the screwdriver onto the coupling of the 90 screwdriver blade with the blade held in place in a mini module 3 Using the holes located on the edge of each module to hold screws press the screwdriver blade securely into the screwhead 4 Slide the Screwholder forward so that the screw is held securely to the blade by the Screwholder Insert 5 After partially inserting the screw into a predrilled hole slide the Screwholder back toward the Handle Turn the Screwholder so that the Screwholder Insert is positioned behind the screwdriver head to provide better visibility of the operative site 6 Manually turn the Turning Handle clockwise to insert the screw To remove the screw turn the Turning Handle counterclockwise Gently rock the screwdriver head trom side to side to release the screwdriver blade from the screwhead 7 To remove the 90 screwdriver blade use the insert removal pin located on each module or use the Instrument for Removal of Inserts by pressing the pin firmly through the hole in the Gear Cover Mini module Easy to pick up and remove screwdriver shafts and drill bits Screwholder Screwholder insert 4 Synthes CMF 90 Screwdriver User s Manual Disassembly 05 505 002 05 001 098 98 Synthes CMF 5 Cleaning Cleaning Warning Universal preca2. Synthes CMF Synthes Canada Ltd 1302 Wrights Lane East 2566 Meadowpine Boulevard West Chester PA 19380 Mississauga Ontario LSN 6P9 Telephone 610 719 5000 Telephone 905 567 0440 To order 800 523 0322 To order 800 668 1119 Fax 610 251 9056 Fax 905 567 3185 www synthes com PlusDrive and Synthes are trademarks of Synthes Inc or its affiliates Printed in U S A 11 11 J7173 B
3. processor to ensure that the processing Is actually performed using equipment materials and personnel in the reprocessing facility and achieves the desired result This requires verification and routine monitoring of the process Likewise any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences 10 Synthes CMF 90 Screwdriver User s Manual 90 Screwdriver Set 01 505 002 Instrument Tray and Modules 60 505 003 60 505 004 60 505 005 60 505 006 68 505 009 Instruments 03 505 003 03 505 004 03 505 005 03 505 006 Ua aU DUZ 03 505 008 03 505 010 03 505 011 03 505 012 03 505 020 03 505 022 03 505 024 03 505 030 03 505 032 03 505 034 03 505 041 03 505 044 03 505 047 03 505 065 03 505 066 03 505 067 03 505 051 03 505 054 03 505 057 Instrument Tray for 90 Screwdriver Mini Module 1 5 mm for Instrument Tray tor 90 Screwdriver Mini Module 2 0 mm for Instrument Tray tor 90 Screwdriver Mini Module 2 4 mm for Instrument Tray for 90 Screwdriver Lid for Instrument Tray for 90 Screwdriver Shaft for 90 Screwdriver 2 ea Handle for 90 Screwdriver 2 ea Turning Handle for 90 Screwdriver 2 ea Drivershaft for 90 Screwdriver 2 ea Gear Cover for 90 Screwdriver 4 ea Gear for 90 Screwdriver 4 ea Screwholder for 90 Screwdriver without Insert 2 ea Screwholder Inserts for
4. 20 a 120 C N A Drying If a dry cycle is not included in a mechanical washer or if the device is not processed in a mechanical washer Dry each part thoroughly inside and out to prevent rusting and malfunction Use a soft lint free cloth to avoid damage to the surfaces Pay special attention to threads ratchets and hinges or areas where fluid can accumulate Open and close parts so that all areas are reached Dry hollow parts using the air jet with clean compressed air 8 Synthes CMF 90 Screwdriver User s Manual Maintenance Instruments 05 001 098 98 Maintenance Spray for Electric Pen Drive 05 505 002 Spray Adaptor for 90 Screwdriver Warning Universal precautions for handling contaminated biohazardous materials should be observed Before sterilization the screwdriver Shaft and the Handle must be oiled Use the Synthes Maintenance Spray for Electric Pen Drive as in Step 8 of the disassembly chart and follow the steps below 1 Reassemble the screwdriver Shaft as in Step 6 of the disassembly chart 2 Click the Spray Adaptor onto the Maintenance Spray 3 Press the assembled screwdriver Shaft tightly onto the Spray Adaptor 4 Wrap the other end of the Shaft with a cloth to catch excess oil or hold over a wash basin 5 Apply spray once briefly approximately 1 sec Always spray away from the body 6 Remove excess oil with a cloth after spraying 7 Repeat the same
5. 90 Screwdriver Instructions for disassembly cleaning and maintenance User s Manual Y s ee a gt SYNIHES Instruments and implants approved by the AO Foundation CMF 90 Screwdriver The Synthes 90 Screwdriver consists of a screwdriver handle shaft screw holder screw holder insert and a variety of attachments such as drill bits and screwdriver blades for manual and powered right angled predrilling and insertion of screws Low profile head Minimal overall height Optimized drive design Easy to clean Facilitates intraoral treatment of subcondylar fractures Reliable transmission of force Drive shaft designed to transmit the torque required for screw insertion Optimized bearings minimize mechanical wear and prolong instrument life Broad range of applications Minimally invasive predrilling and insertion of screws in the mandible without a transbuccal approach Examples Plate fixation of bilateral sagittal split osteotomies BSSO Endoscopically supported plate fixation of subcondylar fractures Screwholder The Screwholder can be turned at an angle behind the head Easier visibility Simple handling Minimally invasive Predrilling Suitable for right angled predrilling Can be attached to a power source by removing the Turning Handle maximum input speed 15 000 rpm Adaptor for Intra
6. Coupling 05 001 103 98 allows the 90 Screwdriver to connect to the Synthes Electric Pen Drive for drilling under power Easy exchange of drill bits and screwdriver blades Synthes CMF 90 Screwdriver User s Manual Indications and Warnings Indications The Synthes 90 Screwdriver is indicated for the manual and powered predrilling and insertion of bone fixation screws In oral and maxillofacial surgery Warnings To prevent injuries ensure that the 90 Screwdriver is not con nected to power when inserting or removing drill bits Always use irrigation when drilling under power to minimize the risk of necrosis Allow the device to cool for 2 minutes after drilling or before changing attachments To minimize the risk of overheating and to ensure optimal func tion of the instrument and attachments Synthes recommends the use of the Synthes Maintenance Spray after each use of the 90 Screwdriver Improper use may cause the system to overheat and injure the patient or user Refer to the Maintenance section tor the manual for more details To avoid risk of damage to the instrument or patient do not ex ceed the 15 000 rom maximum input speed for the 90 Screw driver Do not use force or bend the drill bit when drilling This may damage the instrument and cause injury to the patient or user Synthes CMF 1 Assembly Instruments 03 505 003 Shaft for 90 Screwdriver 03 505 004 H
7. Remove gross soil using a soft bristled brush or soft lint free cloth Manually clean the device for a minimum of two and a half minutes in a freshly prepared neutral pH enzymatic or detergent solution Follow the enzymatic cleaner or detergent manufacturer s instructions for the correct dilution temperature and exposure time Use a soft bristled brush to remove soil and debris Actuate movable device features to expose areas to detergent solution Clean device under water to prevent aerosolization of contaminants Note fresh solution is a newly made clean solution Rinse the parts 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 moveable device features in order to rinse thoroughly under running water Visually inspect parts Repeat steps 2 through 4 until no visible soil remains on device Assemble components into case and load into an automated washer Synthes CMF 7 Cleaning Mechanical method Equipment Washer disinfector neutral enzymatic cleaner and or detergent with a pH lt 8 5 Use the following cycle parameters Cycle Time minutes Temperature Water Type of Detergent Prewash 2 Cold tap water N A Enzymatic wash 5 Cool to warm tap water Neutral pH lt 8 5 Wash 1 2 Warm tap water gt 40 C Detergent with pH lt 8 5 Rinse 5 Warm to hot DI or PURW gt 40 C N A Dry
8. Screws for 90 Screwdriver 1 5mm and 2 0 mm 2 4 mm 1 0 mm Drill Bits for 90 Screwdriver 11 mm length 4 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 1 1 mm Drill Bits for 90 Screwdriver 11 mm length 4 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 1 5 mm Drill Bits for 90 Screwdriver 13 mm length 6 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 21 mm length 14 mm stop 23 mm length 16 mm stop 25 mm length 18 mm stop 1 8 mm Drill Bits for 90 Screwdriver 13 mm length 6 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop Note For additional information please refer to package insert 03 505 101 03 505 103 03 505 110 03 505 111 03 505 112 03 505 120 03 505 121 05 505 002 05 505 003 Laman i enenerereres i Seene 00 90 200000000100 a 6 e r Cruciform Screwdriver Shafts self retaining for 90 Screwdriver 2 ea 1 5 mm 2 0 mm 2 4 mm StarDrive Screwdriver Shafts self retaining for 90 Screwdriver 2 ea 1 3 mm 1 5 mm 2 0 mm PlusDrive Screwdriver Shafts self retaining for 90 Screwdriver 2 ea 1 3 mm 1 5 mm 2 0 mm Spray Adaptor for 90 Screwdriver Instrument for Removal of Inserts for 90 Screwdriver Synthes CMF 11 90 Screwdriver Set 01 505 002 Matrix Instrument Tray and Modules 68 505 042 68 505 043 68 505 040 68 505 050 Instrument Tray for Mini Module for 90 Screwdriver Li
9. andle for 90 Screwdriver 03 505 005 Turning Handle for 90 Screwdriver 03 505 007 Gear Cover for 90 Screwdriver 03 505 008 Gear for 90 Screwdriver 03 505 010 Screwholder for 90 Screwdriver without Insert Warning To prevent injuries ensure that the 90 screwdriver is not attached to power when inserting attachments hm WN Attach the Screwholder to the shaft end of the Handle Attach the Shaft to the threaded end of the Handle Insert the Gear into the head of the Shaft Assemble the Gear Cover to the head of the Shaft Use the pins located on the Turning Handle to tighten the Gear Cover in place Must be done before the Turning Handle is assembled 5 Attach the Turning Handle to the Handle 6 To remove attachments repeat Steps 1 5 in reverse order 2 Synthes CMF 90 Screwdriver User s Manual Drilling Instruments 05 001 010 98 Electric Pen Drive 60 000 rpm 05 001 103 98 Adaptor for Intra Coupling for Pen Drive 05 001 010 98 05 505 003 Instrument for Removal of Inserts for 90 Screwdriver Note The Adaptor for Intra Coupling for attachment to 05 001 103 98 the Synthes Electric Pen Drive meets ISO 3964 EN 23 964 standard Warning Do not exceed 15 000 rom maximum input speed for 90 Screwdriver The 90 Screwdriver has a gear ratio of 2 1 05 505 003 The 90 Screwdriver Handle has an ISO standard intra coupling for connectin
10. d tor 68 505 042 MatrixMANDIBLE Mini Module Tray tor 90 Screwdriver MatrixMIDFACE Mini Module Tray tor 90 Screwdriver MatrixMIDFACE Drill Bits 03 505 035 03 505 036 03 505 037 03 505 026 62505027 1 1 mm Drill Bits for 90 Screwdriver 11 mm length 4 mm stop 13 mm length 6 mm stop 15 mm length 8 mm stop 1 25 mm Drill Bits for 90 Screwdriver 17 mm length 10 mm stop 19 mm length 12 mm stop MatrixMANDIBLE Drill Bits 03 505 075 03 505 076 03 505 078 03 505 081 03 505 082 03 505 084 03 505 085 03 505 086 03 505 087 03 505 091 03505 092 03 505 094 1 5 mm Drill Bits for 90 Screwdriver 13 mm length 6 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 1 8 mm Drill Bits for 90 Screwdriver 13 mm length 6 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 21 mm length 14 mm stop 23 mm length 16 mm stop 25 mm length 18 mm stop 2 4 mm Drill Bits for 90 Screwdriver 13 mm length 6 mm stop 15 mm length 8 mm stop 19 mm length 12 mm stop 03 503 081 03 503 083 Also Available MatrixMANDIBLE Screwdriver Blade self retaining for 90 Screwdriver MatrixMIDFACE Screwdriver Blade self retaining for 90 Screwdriver 05 001 098 98 Maintenance Spray for Electric Pen Drive 05 001 103 98 Adaptor for Intra Coupling for Pen Drive 12 Synthes CMF 90 Screwdriver User s Manual SYNTHES CMF 2009 Synthes Inc or its affiliates All rights reserved
11. g to an appropriate dental power source Figure 1 The screwdriver can also be connected to the Electric Pen Drive using the Adaptor for Figure 1 05 505 003 Intra Coupling for Pen Drive Remove the Turning Handle from the proximal end of the screwdriver Handle to access the intra coupling for drilling under power To drill with the 90 Screwdriver 1 Load a drill bit by pressing the head of the screwdriver onto the coupling end of the 90 screwdriver drill bit with the drill bit held in place in the mini module 2 Remove the Turning Handle from the screwdriver Handle and insert an appropriate powered drive unit with an intra coupling into the screwdriver Handle The powered drive unit must have an intra coupling in order to connect to the screwdriver Handle Note Use the Adaptor for Intra Coupling with the Electric Pen Drive 3 To remove the drill bit use the insert removal pin located on the module or use the Instrument for Removal of Inserts by pressing the pin firmly through the hole in the Gear Cover ISO 3964 EN 23 964 Synthes CMF 3 Inserting Screws Instruments Screwholder Inserts for Screws 03 505 011 1 5 mm and 2 0 mm 03 505012 2 4mm 05 505 003 Instrument for Removal of Inserts The Screwholder Insert can be used for improved blade retention of screws When not in use it can be retracted and positioned behind the screwdriver head for better visibility of the operative site 1
12. procedure Steps 3 6 for the screwdriver Handle Attention Only use the Synthes Maintenance Spray for Electric Pen Drive Its composition is compatible with requirements in the operating room Lubricants with other compositions may compromise the mechanism and void the warranty Synthes CMF 9 Sterilization Sterilization Synthes nonsterile devices should be sterilized before use The following are the recommendations for the sterilization of Synthes devices Cycle Type Minimum Sterilization Minimum Sterilization Minimum Exposure Time Exposure Temperature Dry Time Prevacuum A minutes 132 C 270 F 20 minutes Notes Dry times may be highly variable due to differences in packaging materials e g nonwoven wraps environmental conditions steam quality device materials total mass sterilizer performance and varying cool down time The user should employ verifiable methods e g visual inspection for achieving adequate drying where the manufacturer s recommendations and the user s results differ These parameters are only valid for devices that are adequately cleaned These parameters are only valid for a properly installed maintained and calibrated AAMI compliant healthcare sterilizer The instructions provided above have been validated by the medical device manufacturer as being capable of preparing a nonsterile Synthes medical device It remains the responsi bility of the
13. utions for handling contaminated biohazardous materials should be observed Preparation for Decontamination 1 The 90 Screwdriver should be reprocessed as soon as Is reasonably practical following use Disassemble the device according to the instructions on page 5 before cleaning Remove sharp parts for manual cleaning or place into a separate tray Lumens and cannulas should be manually processed before cleaning Soak and or rinse heavily soiled parts or cannulated parts before cleaning to loosen any dried soil or debris Use a neutral pH enzymatic soak or detergent to soak parts Follow the enzymatic cleaner or detergent manufacturer s instructions for use for correct exposure time temperature and concentration Use cool tap water to rinse all parts Synthes parts must be cleaned separately from Synthes instrument trays and Synthes graphic cases unless other wise noted Lids should be removed from the graphic case and modules for the cleaning process if applicable It is the responsibility of the end user to ensure that all equipment used to reprocess Synthes devices Is properly installed validated maintained and calibrated 6 Synthes CMF 90 Screwdriver User s Manual Mechanical method Precleaning 1 Disassemble the 90 Screwdriver according to the instructions on page 5 before cleaning Rinse soiled parts under running cold tap water for a minimum of two minutes
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