90° Screwdriver. Instructions for disassembly, cleaning

90° Screwdriver. Instructions for
disassembly, cleaning and maintenance.
User’s Manual
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
Minimal
overall height
Synthes CMF 90° Screwdriver User’s Manual
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-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
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 connected 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 function 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
for the manual for more details.
To avoid risk of damage to the instrument or patient, do not exceed the 15,000 rpm maximum input speed for the 90° Screwdriver.
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 90º Screwdriver
03.505.004
Handle for 90º Screwdriver
03.505.005
Turning Handle for 90º Screwdriver
03.505.007
Gear Cover for 90º Screwdriver
03.505.008
Gear for 90º Screwdriver
03.505.010
Screwholder for 90º Screwdriver, without Insert
Warning: To prevent injuries, ensure that the 90º
screwdriver is not attached to power when inserting
attachments.
1
2
3
4
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.
1
2
3
4
5
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
05.505.003
Instrument for Removal of Inserts,
for 90º Screwdriver
Note: The Adaptor for Intra-Coupling, for attachment to
the Synthes Electric Pen Drive, meets ISO 3964/EN 23 964
standard.
05.001.010.98
05.001.103.98
Warning: Do not exceed 15,000 rpm maximum input
speed for 90º Screwdriver. The 90º Screwdriver has a gear
ratio of 2:1.
The 90º Screwdriver Handle has an ISO standard*
intra-coupling for connecting to an appropriate dental
power source (Figure 1). The screwdriver can also be
connected to the Electric Pen Drive using the Adaptor for
Intra-Coupling for Pen Drive.
Figure 1
05.505.003
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 90º Screwdriver:
1 Load a drill bit by pressing the head of the screwdriver
onto the coupling end of the 90º 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
03.505.011
03.505.012
Screwholder Inserts for Screws,
1.5 mm and 2.0 mm
2.4 mm
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 Attach the appropriate Screwholder Insert to the coupling
on the Screwholder.
2 Press the head of the screwdriver onto the coupling of the
90º 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
from side to side to release the screwdriver blade from
the screwhead.
7 To remove the 90º 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
1
OR
2
3
4
5
1
2
6
7
8
05.505.002
05.001.098.98
05.505.002
05.001.098.98
Synthes CMF
5
Cleaning
Cleaning
Warning: Universal precautions 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.
2. Disassemble the device according to the instructions on
page 5 before cleaning.
3. Remove sharp parts for manual cleaning or place into a
separate tray.
4. Lumens and cannulas should be manually processed
before cleaning.
5. 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.
6. Synthes parts must be cleaned separately from Synthes
instrument trays and Synthes graphic cases unless otherwise noted. Lids should be removed from the graphic
case and modules for the cleaning process, if applicable.
7. 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.
2. Rinse soiled parts under running cold tap water for a
minimum of two minutes. Remove gross soil using a
soft bristled brush or soft, lint-free cloth.
3. Manually clean the device for a minimum of two-and-ahalf 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 softbristled 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.
4. 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.
5. Visually inspect parts. Repeat steps 2 through 4 until
no visible soil remains on device.
6. 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 ≤ 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 ≤ 8.5
Wash 1
2
Warm tap water ( >40°C)
Detergent with pH ≤ 8.5
Rinse
5
Warm to hot DI or PURW (>40°C)
N/A
< 120°C
N/A
Dry
20
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 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
Exposure Time
Exposure Temperature
Minimum
Dry Time
Prevacuum
4 minutes
20 minutes
132°C (270˚F)
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 responsibility of the 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
Instrument Tray for 90° Screwdriver
60.505.004
Mini Module 1.5 mm for Instrument Tray,
for 90° Screwdriver
60.505.005
Mini Module 2.0 mm for Instrument Tray,
for 90° Screwdriver
60.505.006
Mini Module 2.4 mm for Instrument Tray,
for 90° Screwdriver
68.505.009
Lid for Instrument Tray, for 90° Screwdriver
Instruments
03.505.003
03.505.004
03.505.005
03.505.006
03.505.007
03.505.008
03.505.010
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.
03.505.011
03.505.012
Screwholder Inserts for Screws,
for 90° Screwdriver
1.5 mm and 2.0 mm
2.4 mm
03.505.020
03.505.022
03.505.024
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
03.505.030
03.505.032
03.505.034
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
03.505.041
03.505.044
03.505.047
03.505.065
03.505.066
03.505.067
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
03.505.051
03.505.054
03.505.057
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
03.505.101
03.505.103
Cruciform Screwdriver Shafts,
self-retaining, for 90° Screwdriver, 2 ea.
1.5 mm/2.0 mm
2.4 mm
03.505.110
03.505.111
03.505.112
StarDrive Screwdriver Shafts,
self-retaining, for 90° Screwdriver, 2 ea.
1.3 mm
1.5 mm
2.0 mm
03.505.120
03.505.121
PlusDrive Screwdriver Shafts,
self-retaining, for 90° Screwdriver, 2 ea.
1.3 mm
1.5 mm/2.0 mm
05.505.002
05.505.003
Spray Adaptor for 90° Screwdriver
Instrument for Removal of Inserts,
for 90° Screwdriver
Note: For additional information, please refer to package insert.
Synthes CMF
11
90° Screwdriver Set (01.505.002)
Matrix Instrument Tray and Modules
68.505.042
Instrument Tray for Mini Module
for 90° Screwdriver
68.505.043
Lid for 68.505.042
68.505.040
MatrixMANDIBLE Mini Module Tray
for 90° Screwdriver
68.505.050
MatrixMIDFACE Mini Module Tray
for 90° Screwdriver
MatrixMIDFACE Drill Bits
1.1 mm Drill Bits, for 90° Screwdriver
03.505.035
11 mm length, 4 mm stop
03.505.036
13 mm length, 6 mm stop
03.505.037
15 mm length, 8 mm stop
03.505.026
03.505.027
1.25 mm Drill Bits, for 90° Screwdriver
17 mm length, 10 mm stop
19 mm length, 12 mm stop
MatrixMANDIBLE Drill Bits
1.5 mm Drill Bits, for 90° Screwdriver
03.505.075
13 mm length, 6 mm stop
03.505.076
15 mm length, 8 mm stop
03.505.078
19 mm length, 12 mm stop
03.505.081
03.505.082
03.505.084
03.505.085
03.505.086
03.505.087
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
03.505.091
03.505.092
03.505.094
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
12
Synthes CMF 90° Screwdriver User’s Manual
03.503.081
03.503.083
MatrixMANDIBLE Screwdriver Blade,
self-retaining, for 90° Screwdriver
MatrixMIDFACE Screwdriver Blade,
self-retaining, for 90° Screwdriver
Also Available
05.001.098.98
05.001.103.98
Maintenance Spray, for Electric Pen Drive
Adaptor for Intra-Coupling for Pen Drive
Synthes CMF
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
© 2009 Synthes, Inc. or its affiliates. All rights reserved.
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185
PlusDrive and Synthes are trademarks of Synthes, Inc. or its affiliates.
www.synthes.com
Printed in U.S.A. 11/11 J7173-B
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