DePuy Synthes Air Pen Drive 05.001.082 Instructions for Use March 2018.pdf
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Compact drive with specific attachments for a wide spectrum of applications
Air Pen Drive
Instructions for Use
Page 3
Table of Contents
Introduction
Air Pen Drive System
Attachments
Cutting Tools
General Information
3
Explanation of Symbols
5
Air Pen Drive
6
Angular Coupling (05.001.085)
8
Hand Switch (05.001.082)
9
Foot Switch (05.001.081)
10
General Information
11
Drill Attachments
12
Screw Attachments
14
Kirschner Wire Attachment
15
Saw Attachments
16
Burr Attachments
18
Adapter for Intra Coupling
20
Perforators
21
Craniotome Attachment
23
General Information
24
Air Pen Drive
Instructions for Use
DePuy Synthes
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Table of Contents
Care and Maintenance
General Information
25
Cleaning and Disinfection
• Preparation Prior to Reprocessing
• Manual Cleaning Instructions
• Automated Cleaning Instructions
with Manual Pre-cleaning
26
26
27
29
Maintenance and Lubrication
33
Function Control
36
Packaging, Sterilization and Storage
37
Repairs and Technical Service
38
Disposal
39
Troubleshooting
40
System Specifications
42
Ordering Information
47
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DePuy Synthes Air Pen Drive
Instructions for Use
Page 5
Introduction
General Information
Intended use
The Air Pen Drive is an air-driven system to be used for
treatment in general traumatology, as well as for surgeries in the areas of the hand, foot, spine, maxillofacial
and neurosurgery.
Safety instructions
The surgeon has to evaluate if the machine is suitable
for an application, based on power limitation of the
machine, attachment and cutting tool regarding bone
strength/anatomical situation as well as handling of the
machine, attachment and cutting tool regarding bone
size. In addition, the contraindications of the implant
have to be respected. Please refer to the corresponding
”Surgical Techniques” of the implant system used.
The Air Pen Drive System is only to be used for patient
treatment after careful consultation of the instructions
for use. It is recommended that an alternative system is
available to use during application, as technical problems
can never be completely ruled out.
The Air Pen Drive System is designed for use by physicians and trained medical personnel.
Always wear personal protective equipment (PPE)
including safety goggles when handling with the Air
Pen Drive.
To prevent overheating, always respect the duty cycles
for each attachment listed on page 42.
For the tool to function properly, Synthes recommends
that it is cleaned and serviced after each use in accordance with the process recommended in the chapter
”Care and Maintenance”. Compliance with these specifications can considerably extend the service life of the
tool. Only use Synthes oil to lubricate the tool.
Efficiently working cutting tools are the basis for successful surgery. Therefore, it is mandatory to check used
cutting tools after every use for wear and/or damage
and to replace them if necessary. We recommend using
new Synthes cutting tools for every surgery.
Cutting tools must be cooled with irrigation liquid to
prevent heat necrosis.
The user of the product is responsible for proper use of
the equipment during surgery.
DO NOT use any component if damage is apparent.
DO NOT use this equipment in presence of oxygen,
nitrous oxide or a mixture consisting of flammable anesthetic and air. Never use oxygen to run air-powered systems (danger of explosion!); only use compressed air or
compressed nitrogen.
To ensure proper operation of the tool, use only Synthes
original accessories.
Recommended operating pressure: 6–8 bar (see also
chapter System Specification)
Only use original Synthes hoses for compressed air.
Before first and every use, power tools and their accessories/attachments have to run through the complete
reprocessing procedure. Protective covers and foils must
be fully removed before sterilization.
If the Air Pen Drive System is used in conjunction with
an implant system make sure to consult the corresponding ”Surgical Technique”.
This system requires regular maintenance service, at least
once a year, in order to maintain its functionality. This
service has to be performed by the original manufacturer
or an authorized site.
Unusual Transmissible Pathogens
Surgical patients identified as at-risk for CreutzfeldtJakob disease (CJD) and related infections should be
treated with single-use instruments. Dispose of instruments used or suspected of use on a patient with CJD
after surgery and/or follow current national recommendations.
Check instruments for correct adjustment and functioning prior to every use.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 6
Introduction
General Information
Precautions:
• Never use oxygen to run air-powered systems
(danger of explosion!); only use compressed air or
compressed nitrogen.
• To avoid injuries, the locking mechanism of the
tool has to be activated before every manipulation
and before placing the tool back down, i.e. the
mode switch has to be in the LOCK positon ( ).
• Should the machine drop on the floor and have
visible defects, do not use it anymore and send it to
the Synthes service center.
• If a product drops on the floor, fragments may split
off. This represents danger for the patient and user
as:
• these fragments may be sharp.
• unsterile fragments may enter the sterile field or
hit the patient.
Accessories/Scope of delivery
The main components in the APD System are the handpiece, Hand Switch, Foot Switch, Air Hose as well as attachments and accessories. An overview of all components belonging to the Air Pen Drive System can be
found in the chapter ”Ordering Information”.
For using the Air Pen Drive System the following components are a must:
• Air Pen Drive 60,000 rpm (05.001.080)
• Hand Switch (05.001.082) or Foot Switch (05.001.081,
also a Double Air Hose from Synthes is necessary to
connect the Foot Switch e.g. 519.510)
• Double Air Hose, for Air Pen Drive (05.001.083 or
05.001.084)
• At least one attachment belonging to the system and
cutting tool fitting to the attachment
For an optimal function of the system only Synthes cutting tools shall be used.
Synthes recommends the use of the specifically designed
Synthes Vario Cases and of the specifically designed
Washing Basket (68.001.800) to sterilize and store the
system.
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DePuy Synthes Air Pen Drive
Instructions for Use
For care and maintenance special tools are available,
such as cleaning brushes, Synthes Maintenance Oil
for EPD and APD (05.001.095), M
aintenance Spray
(05.001.098) and Maintenance Unit (05.001.099).
No oils from other manufacturers may be used. Only
Synthes oil may be used.
Lubricants with other compositions can cause jamming,
can have a toxic effect or can have a negative impact on
the sterilization results. Only lubricate the power tool
and the attachments when clean.
Locating of the instrument or fragments of
instruments
Synthes instruments are designed and manufactured to
perform within the scope of their intended use. However, if a Power Tool or accessory/attachment breaks
during use, a visual inspection or a medical imagine device (e.g. CT, Radiation Devices, etc.) can aid in locating
the fragments and/or components of the instrument.
Storage and Transportation
Only use the original packaging for dispatch and transport. If the packing material is no longer available,
please contact the Synthes office. For storage and transport environmental conditions, see page 43.
Warranty/Liability
The warranty for the tools and accessories does not
cover damage of any kind resulting from wear, improper
use, improper reprocessing and maintenance, damaged
seal, use of non Synthes cutting tools and lubricants or
improper storage and transport.
The manufacturer excludes liability for damage resulting
from improper use, neglected or unauthorized maintenance or servicing of the tool.
For further information on the warranty please contact
your local Synthes office.
Page 7
Introduction
Explanation of Symbols
Caution
Read the provided instructions for use before
operating the device.
Do not immerse device in liquids.
0123
The device meets the requirements of directive 93/42/EEC for medical devices. It is authorized by an independent notified body for
which it bears the CE symbol.
Locked symbol. Drive Unit is off for safety.
Date of manufacture and manufacturer
Date of manufacture
non sterile
Non sterile
2
Do not reuse
Products intended for single use must not be
reused.
Reuse or reprocessing (e.g. cleaning and
resterilization) may compromise the §structural integrity of the device and/or lead to device failure, which may result in patient injury,
illness or death. Furthermore, reuse or reprocessing of single use devices may create a risk
of contamination e.g. due to the transmission
of infectious m
aterial from one patient to
another. This could result in the injury or
death of the patient or user.
Synthes does not recommend reprocessing
contaminated products. Any Synthes product
that has been contaminated by blood, tissue
and/or bodily fluids/matter should never be
used again and should be handled according
to hospital p
rotocol. Even though they may
appear undamaged, the products may have
small defects and internal stress patterns that
may cause material fatigue.
Non sterile
Range of temperature
Range of relative humidity
Range of atmospheric pressure
Do not use if package is damaged.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 8
Air Pen Drive System
Air Pen Drive
Mounting the air hose on the handpiece
The Air Hose (05.001.083 or 05.001.084) is coupled by
fitting the pins on the hose coupling into the grooves on
the coupling for hoses on the handpiece and turning the
hose coupling clockwise. Attach the other end of the air
hose to the compressed air or nitrogen source or to the
Foot Switch (05.001.081, see page 10). Ensure that the
coupling geometry of the air hose is compatible with the
geometry of the wall coupling. If the operating room
does not have an exhaust air system then use the Air
Diffusor (519.950) to diffuse the air. The Air Diffusor is
connected between the source and the air hose. To disconnect the air hose simply turn the hose coupling piece
counterclockwise and pull it off the handpiece. Remove
the air hose from the compressed air or nitrogen source
or from the Foot Switch.
Adjusting the handpiece
1 Adjustment sleeve
2 Release sleeve for attachment
3 Coupling for hoses
4 LOCK position
5 Hand Switch position
6 Foot Switch position
7 Lock slide for adjustment sleeve
3
1
6
DePuy Synthes Air Pen Drive
Instructions for Use
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Page 9
Adjustment sleeve
To avoid an unintentional change of the operating mode
the lock slide for adjustment sleeve 7 locks the adjustment sleeve automatically. To be able to move the
adjustment sleeve the lock slide has to be pushed backwards. After having reached the desired position release
the lock slide and the adjustment sleeve is locked in the
desired position.
4
Lock position
5
Hand switch position
6 7
Foot switch p
osition
By turning the adjustment sleeve into the hand switch
position
, the handpiece can be used with the Hand
Switch. In the foot switch position
only the Foot
Switch shall be used! If the foot switch position
is set
and no Foot Switch is attached the handpiece will run
with full speed.
Either a Hand Switch or a Foot Switch can be used for
speed control.
The LOCK position is used for safety switch-off when
changing attachments and tools. This prevents accidental start-up of the unit while performing these activities.
For instructions on mounting the attachments see the
chapter ”Attachments”.
Precaution: The air hoses have to be connected
properly and should never be squeezed with sharp
objects or obstructed by any loads. Non-respect
might lead to bursting of the outer hose!
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 10
Air Pen Drive System
Angular Coupling (05.001.085)
The Angular Coupling (05.001.085) can be connected
to the Air Pen Drive (05.001.080) and the Air Hose
(05.001.083 or 05.001.084) and is used to guide the air
hose away from the handpiece in a 45° angle. It allows
360° rotation.
Mounting the Angular Coupling
The Angular Coupling is coupled to the handpiece by fitting the pins into the grooves on the coupling for hoses
on the handpiece and turning the Angular Coupling
clockwise. The Air Hose is then connected to the Angular Coupling by fitting the pins on the Air Hose coupling
into the grooves of the Angular Coupling by turning it
clockwise. To disassemble it turn the parts counter-clockwise and pull the Air Hose off the Angular Coupling, and
then the Angular Coupling off the handpiece.
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DePuy Synthes Air Pen Drive
Instructions for Use
Page 11
Air Pen Drive System
Hand Switch (05.001.082)
1
2
3
4
5
Positioning arrow
Pull-out finger rest
Positioning arrow
Guide groove
Locking switch
5
Mounting the Hand Switch on the Handpiece
Position the Hand Switch on the handpiece so that both
positioning arrows 1 of the Hand Switch cover the positioning arrows 3 over the guide grooves 4 of the pen.
Then press downward vertically until the Hand Switch
clicks into position.
2
1
3 4
Removing
To remove the Hand Switch, grasp the lever and pull it
away upwards.
Operation
The adjustment sleeve on the pen must be set on the
hand switch position for working with the Hand Switch.
The length of the Hand Switch can be individually adjusted with the pull-out finger rest 2. The speed can be
continuously adjusted by operating the Hand Switch. The
Hand Switch can be deactivated (LOCK position) or activated (ON position) with the locking switch 5.
Precaution: Do not set the adjustment sleeve in the
Foot Switch position, if the system is used with the
Hand Switch only and no Foot Switch is connected!
This will make the pen run constantly and can be
very dangerous for patient and OR staff.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 12
Air Pen Drive System
Foot Switch (05.001.081)
1
2
3
4
5
Pedal
Irrigation ON/OFF button*
Plug for Double Air Hose
Plug for Irrigation Control Unit*
Plug for Air Pen Drive Hose
Connecting the Foot Switch
Connect a Double Air Hose (519.510, 519.530, 519.550
for System Synthes; 519.610, 519.630, 519.650 for System
Dräger; 519.511, 519.531 for System BOC/Schrader) to
the male plug for the Double Air Hose on the Foot
Switch 3 and connect it to the air outlet socket.
Then connect the Double Air Hose for Air Pen Drive
(05.001.083 or 05.001.084) to the female plug for Double Air Hoses 5. To remove the air hoses simply slide the
female hose-coupling pieces in direction of the arrow.
Operation
The adjustment sleeve on the pen must be set on the
Foot Switch position for working with the Foot Switch.
The speed can be continuously adjusted with the pedal.
Precaution: Never keep the adjustment sleeve in the
Foot Switch position , if no Foot Switch is connected! This will make the pen run constantly and
can be very dangerous for patient and OR staff.
* The Irrigation Control Unit is no longer available
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DePuy Synthes Air Pen Drive
Instructions for Use
1
2
3
4
5
Page 13
Attachments
General Information
Mounting the attachments on the handpiece
The attachments can be connected in 8 different positions (45° increments). To mount, turn the release sleeve
for the attachments clockwise (see arrow on the release
sleeve) until it engages. The release sleeve protrudes
slightly from the black section of the handpiece towards
the front. Insert the attachment into the attachment
coupling from the front and press it lightly against the
handpiece. The attachment automatically engages. If the
release sleeve accidentally closes, turn the attachment
clockwise while applying slight pressure against the
handpiece until it engages without holding the release
sleeve in place, or repeat the entire connection process.
Check secure holding of the attachment on the handpiece by pulling on the attachment.
Release sleeve
Removing the attachments from the handpiece
Turn the release sleeve for attachments (see page 6)
clockwise u
ntil it disengages. Hold the attachment upward while doing so. Then remove the attachment.
Attachments and accessories
For easier change of burrs, without having the Burr
Attachment or Craniotome Attachment connected to
the handpiece, the Handhold for Change of Instruments
(05.001.074) can be used.
Warranty: Only use Synthes saw blades, burrs and
rasps while working with the Air Pen Drive
attachments. The use of other tools voids the device
warranty.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 14
Attachments
Drill Attachments
Drill Attachments (05.001.030–05.001.032,
05.001.044)
Speed: approx. 1,800 rpm at 6.5 bar
1
The system includes straight Drill Attachments with Mini
Quick, J-Latch and AO/ASIF Coupling and a 45° cannulated AO/ASIF Drill Attachment.
The 45° Drill Attachment with AO/ASIF Coupling
(05.001.044) has a cannulation of 1.6 mm, which permits the use of this attachment for drilling and reaming
over Kirschner Wire (e.g. for cannulated screws and for
cup and cone technique).
1
1
Mounting and removing tools
Lock unit. Pull back the release sleeve and insert/remove
the tool.
1 Release sleeve
Drill Attachment 45°, cannulated,
with Jacobs Chuck (05.001.120)
Speed: approx. 1,800 rpm at 6.5 bar
Clamping range: 0.5 mm–4.7 mm
The cannulation of 1.6 mm permits the use of this
attachment for drilling and reaming over Kirschner
Wire (e.g. for cannulated screws and for cup & cone
technique).
Mounting and removing tools
Lock unit. Open the chuck with the key provided
(310.932) or by hand by turning the two moving parts
clockwise with respect to each other. Insert/remove the
tool. Close the chuck by turning the moving parts counterclockwise and tighten it by turning the key clockwise.
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DePuy Synthes Air Pen Drive
Instructions for Use
1
1 Release sleeve
Page 15
1
Drill Attachment 90°, short (05.001.035)
and long (05.001.036) with Mini Quick Coupling
Speed: approx. 1,800 rpm at 6.5 bar
Due to its very small angled head, the 90° Drill Attachments enable good visibility during operations with
narrow access (e.g. intraoral, shoulder etc.).
Mounting and removing tools
Lock unit. Move the slide 1 to the side following the
arrow on the slide and insert/remove the tool. To secure
the tool, push the slide back again.
1
1 Slide
Oscillating Drill Attachment (05.001.033)
Frequency: approx. 3,200 osc./min at 6.5 bar
The oscillating drilling movement of the Oscillating Drill
Attachment prevents tissue and nerves from wrapping
around the drill. This can considerably improve the operating results.
Mounting and removing tools
Cutting tools with a Mini Quick Coupling can be
clamped with the Oscillating Drill Attachment. To do
this, lock the unit, pull back the release sleeve 1 and
insert/remove the tool.
1
1 Release sleeve
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 16
Attachments
Screw Attachments
Screw Attachments
(05.001.028, 05.001.029, 05.001.034)
Speed: approx. 400 rpm at 6.5 bar
The system includes screw attachments with AO/ASIF
coupling, hexagonal and mini quick coupling.
Mounting and removing tools
Lock unit. Pull back the release sleeve and insert/remove
the tool.
Precautions:
• Only use the attachment with 6.5 bar to avoid
higher speed than 400 rpm.
• Always use the appropriate Torque Limiting device while inserting locking screws into a locking
plate.
• The APD contains no reverse mode for removing
screws.
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DePuy Synthes Air Pen Drive
Instructions for Use
1
1 Release sleeve
Page 17
Attachments
Kirschner Wire Attachment
Kirschner Wire Attachment (05.001.037)
Speed: approx. 2,700 rpm at 6.5 bar
With the Kirschner Wire Attachment, Kirschner Wires of
any length with a diameter of 0.6–1.6 mm can be tensioned. The tensioning lever 1 can be rotated by 300°,
permitting individual adjustment (suitable for left and
right-handed users).
1
1 Tensioning lever
Mounting and removing Kirschner Wires
Lock unit. To insert and remove Kirschner Wires, press
the tensioning lever 1. After the lever is released, the
Kirschner Wire is automatically tensioned. To re-grasp,
press the tensioning lever, pull back the unit along the
Kirschner Wire and then release the tensioning lever
again.
Air Pen Drive
Instructions for Use
DePuy Synthes
11
Page 18
Attachments
Saw Attachments
Working with saw attachments
Allow the unit to start up before placing it on the bone.
Avoid heavy pressure on the saw blade so that the cutting process is not slowed and the saw teeth do not bind
up in the bone. The best sawing performance is
achieved by moving the unit slightly to and fro on the
plane of the saw blade. Imprecise cuts indicate worn
saw blades, excessive pressure or jamming of the saw
blade due to tilting.
Information on handling saw blades
Synthes recommends using a new saw blade for each
surgery, as only then can it be ensured that the saw
blade is always optimally sharpened and clean. Used saw
blades present the following risks:
• Necrosis due to excess heat
• Infections due to residues
• Longer cutting time due to reduced sawing
performance
Sagittal Saw Attachment (05.001.039)
Frequency: approx. 22,000 osc./min at 6.5 bar
Sagittal Saw Attachment, centered (05.001.183)
Frequency: approx. 22,000 osc./min at 6.5 bar
2
1
Sagittal Saw Attachment 90° (05.001.182)
Frequency: approx. 16,000 osc./min at 6.5 bar
Changing saw blades
1. Lock unit.
2. Press the clamping button 1, lift the saw blade
and remove it.
3. Push a new saw blade into the saw blade coupling
and move it into the desired position. The saw blade
can be locked in 5 different positions (05.001.039 and
05.001.183) and in 8 different positions (05.001.182)
for optimum positioning (45° increments).
4. Release the clamping button.
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DePuy Synthes Air Pen Drive
Instructions for Use
2
1
1
2
1 Clamping button for saw blades
2 Mounting opening for saw blades
Page 19
Oscillating Saw Attachment (05.001.038)
Frequency: 16,000 osc./min at 6.5 bar
The Oscillating Saw Attachment is used with Synthes
crescentic and 105° angled saw blades.
Changing saw blades
1. Lock unit.
2. Pull back the release sleeve for saw blades 1 and remove the saw blades from the mounting opening 2.
3. Push a new saw blade into the mounting opening
2 and move it into the desired position.
4. Release the release sleeve for saw blades.
Mounting and removing the Guide
for Kirschner Wires (05.001.121)
Secure the Guide for Kirschner Wires on the Oscillating
Saw, by pushing the Guide as far as possible over the attachment from the front, so that it engages in the shape
of the Oscillating Saw.
2
1
1 Release sleeve for saw blades
2 Mounting opening for saw blades
Kirschner Wire B 1.6 mm
Then mount the attachment on the handpiece.
Note: No irrigation nozzle is available for the oscillating saw attachment.
Reciprocating Saw Attachment (05.001.040)
Frequency: 18,000 osc./min at 6.5 bar
Stroke: 2.5 mm
Both Synthes reciprocating saw blades and Synthes rasps
can be used with the Reciprocating Saw Attachment.
1
1 Release sleeve for saw blades
Replacing saw blades
1. Lock unit.
2. Turn the release sleeve for saw blades 1 clockwise
until it engages and remove the saw blade.
3. Insert a new saw blade until slight resistance can be
felt. Turn the saw blade with slight pressure until it
automatically engages.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 20
Attachments
Burr Attachments
Burr Attachments
(05.001.045–05.001.050, 05.001.055, 05.001.063)
Gear ratio: 1:1
The system includes straight and angled Burr Attachments in 3 lengths each (S, M, L). The related burrs are
also marked with S, M and L. Angled XL and XXL Burr
Attachments are available; for these attachments the L
burrs shall be used.
Changing burrs
1. Lock unit.
2. Turn the release sleeve for burrs 1 until it engages in
the UNLOCK position and remove the tool.
3. Insert the new tool as far as possible, turn it slightly
until it locks in place and then turn the release sleeve
for burrs into the LOCK position until it engages. The
burr is correctly clamped when the marking S, M or L
on the burr shank is no longer visible.
Information on handling burrs
• Synthes recommends using a new sterile burr for each
operation. This prevents health risks to the patient.
• Used burrs present the following risks:
• Necrosis due to excess heat
• Longer cutting time due to reduced performance
of the burr
Precautions:
• Burrs must be cooled with irrigation liquid to
prevent heat necrosis.
• The size of the burr attachment must correspond
to the size of the burr (e.g. attachment size S with
burr size S) or one burr size bigger (e.g. attachment
size S with burr size M).
• User and OR personal must wear safety goggles
when working with burrs.
• When the Burr Attachments are not attached to
the handpiece during tool change, use the Handhold (05.001.074) for easier change of burrs.
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DePuy Synthes Air Pen Drive
Instructions for Use
1
1
1 Release sleeve for burrs
Page 21
Drill/Burr Attachment, Straight,
for Round Shafts B 2.35 mm (05.001.123)
Gear ratio 1:1
1
Friction fit attachment for 2.35 mm diameter shafts with
round shaft, J-latch and Mini-quick coupling.
Changing cutting tools
1. Lock unit.
2. Turn the release sleeve (1) until it engages in the UNLOCK position and remove the tool.
3. Insert the new tool and turn the release sleeve into
the LOCK position until it engages.
Precautions:
• The user is liable for the safety and correct application of the Synthes Power Tool including the attachment and the cutting tool including the following items in particular:
• maximum speed of the Drill/Burr Attachment for
Round Shafts with 2.35 mm diameter (05.001.123)
is 60,000 rpm
• the use of appropriate cutting tools (specifically
length and speed)
• the secure fixation of the cutting tool, i.e. the tool
must be chucked at least 20 mm deep
• the instrument must be rotating before contact is
made with the workpiece
• avoid jamming and using the instrument as a lever as this leads to an increased risk of breakage
• Check the vibration and the stability of the used
cutting tool before every usage on the patient. If vibration or instability occur, reduce the speed until
there is no vibration anymore or do not use the
burr.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 22
Attachments
Adapter for Intra Coupling
Adapter for Intra Coupling (05.001.103)
Gear ratio 1:1
The Adapter for Intra Coupling (05.001.103) enables the
use of dental handpieces, mucotomes and dermatomes
designed according to ISO 3964 (EN 23 964) in combination with the Electric Pen Drive (05.001.010) and Air Pen
Drive (05.001.080).
Warranty/Liability: The user is responsible to ensure the compatibility of products used in combination with the Electric- and Air Pen Drive System
and the Adapter for Intra Coupling.
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DePuy Synthes Air Pen Drive
Instructions for Use
Page 23
Attachments
Perforators
Perforator (05.001.054)
Gear reduction: 97:1
The perforator is used with the related trepan burrs
(03.000.350–03.000.351) including the protective
sleeves (05.001.096–03.001.097) to open a cranium
with a thickness of 3 mm or above. The handpiece has to
be in the FWD
position. Hold the perforator perpendicular to the skull at point of penetration and always
apply constant pressure when the trepan burr is engaged in the bone. As soon as the cranium is cut
through, the trepan burr automatically disengages.
Perforator
05.001.054
Trepan Burr
03.000.350–03.000.351
Protection Sleeve
05.001.096–05.001.097
Changing trepan burrs
1. Turn the release sleeve for trepan burrs (1) until
the locking pin (2) disengages from the locking
groove (3). (Position , Fig. 1).
2. Pull off the trepan burr together with the protective
sleeve.
3. Insert a new trepan burr into the protective sleeve and
make sure that the pins on the trepan burr engage
properly in the grooves in the protective sleeve.
4. Place the new trepan burr together with the protective sleeve on the perforator.
5. Turn the release sleeve for trepan burrs (1) until the
locking pin (2) engages in the locking groove (3).
(Position , Fig. 2).
Precautions:
• If conditions such as adherent dura, intracranial
pressure or other underlying abnormalities are
present in the area of the penetration, the perforator may cut the dura. Caution must be observed
when perforating thin skull areas such as temporal bone, infants, children, elderly, or diseased
bone since skull consistencies and thicknesses can
vary and the dura could be cut. Only use the perforator 05.001.054, the trepan burrs 03.000.350–
03.000.351 and the protective sleeves 05.001.096–
05.001.097 on bones with a thickness of 3 mm or
above.
3
2
1
1 Release sleeve for trepan burrs
2 Locking pin
3 Locking groove
Fig. 1
Fig. 2
• It is recommended to cool the trepan burr during
trepanation (use the irrigation nozzle 05.001.076).
• Check function before each use of the perforator.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Page 24
Attachments
Perforators
Perforator with Hudson Coupling (05.001.177)
Gear reduction: 97:1
The Perforator with Hudson coupling is used with a trepan burr / protection sleeve combination – usually referred to as a cranial perforator – with a Hudson end to
open the cranium. The operational mode of the hand
piece has to be FWD
. Hold the perforator perpendicular to the skull at the point of penetration and always
apply constant pressure when the trepan burr is engaged in the bone.
Changing the cranial perforator
1. Attaching the cranial perforator:
First move the coupling sleeve (1) on the adapter toward
the rear, and then completely insert the tool.
After the tool has been fully inserted, release the
coupling sleeve. Check that the tool is properly locked in
the attachment by gently pulling on it.
2. Removing the cranial perforator:
First move the coupling sleeve (1) towards the rear, and
then remove the tool.
Precautions:
• For the use of the trepan burrs or cranial perforators the respective instructions for use with warnings and restrictions of the supplier is valid.
• It is recommended cooling the cutting tool during
trepanation to avoid heat necrosis. Use the irrigation nozzle 05.001.180. Make sure that the irrigation nozzle is placed in a way that the cooling
liquid reaches the tool.
• Check function before each use of the perforator.
• The user is liable for the surgical application.
• The user is liable to check the compatibility of the
Perforator with Hudson Coupling, the Irrigation
Nozzle and the cutting tool used.
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DePuy Synthes Air Pen Drive
Instructions for Use
1
1 Coupling sleeve
Page 25
Attachments
Craniotome Attachment
Craniotome Attachment (05.001.059)
and Dura Guards (05.001.051–05.001.053)
Gear ratio: 1:1
The system includes a Craniotome Attachment and Dura
Guards in 3 lengths (S, M, L). The related burrs are also
marked with S, M and L.
Craniotome Attachment
05.001.059
Cranial Burr
03.000.124S–03.000.126S
Dura Guard
05.001.051–05.001.053
Changing cranial burrs
1. Lock the handpiece.
2. Turn the release sleeve for burrs (1) until it engages
in the UNLOCK position.
3. Pull off the Dura Guard over the burr and remove
the burr.
4. Insert the new burr as far as possible turning it
slightly. The burr is correctly inserted when the Dura
Guard can be properly fitted.
5. Push the Dura Guard over the burr and mount the
Dura Guard on the Craniotome Attachment (pay
attention to the arrows for the correct inserting position (2)). Then turn the release sleeve of the Craniotome Attachment into the LOCK position until it
engages to clamp the burr and the Dura Guard.
6. Check that the Cranial Burr can be turned freely
and that the Dura Guard is well engaged by pulling
on it slightly.
1
1 Release sleeve for burrs and Dura Guard
2 Arrows indicating the proper inserting position
Precautions:
• Only use the Craniotomes with the related Cranial
Burrs.
• Cranial Burrs must be cooled with irrigation liquid to avoid heat necrosis to the nozzle built into
the Dura Guard.
• Avoid side load on the burr and Dura Guard in
order to prevent breakage of the Dura Guard.
• When the Craniotome Attachment is not attached
to the handpiece during tool change, use the Handhold (05.001.074) for easier change of the burr and
Dura Guard.
Air Pen Drive
Instructions for Use
DePuy Synthes
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Cutting Tools
General Information
Intended use
Saw blades
The saw blades are designed for use in traumatology
and orthopaedic surgery of the skeleton, e.g. cutting
bone.
Stainless steel burrs
Stainless Steel Burrs (Small Torx Cutting Tools) are
designed for the use in surgery of the skeleton, i.e.
cutting, shaping, smoothing, drilling, reaming or
burring of bones.
Diamond coated or carbide burrs
Diamond coated or carbide burrs (Small Torx Cutting
Tools) are designed for the use in surgery of the skeleton, i.e. cutting, shaping, smoothing of bones, teeth
and metal.
Single Use/Reprocessing
For best results Synthes recommends using a new cutting tool for each operation. Performing cuts with a new
and sharp cutting tool is faster, more precise and generates less heat development. This results in a shorter surgery time, a reduction of risk of bone necrosis and a better, reproducible result.
All diamond coated or carbide cutting tools are single
use only.
Packaging and Sterility
All cutting tools are available sterile packed.
The manufacturer cannot guarantee sterility if the package seal is broken or if the package is improperly
opened, and assumes no liability in such instances.
Dimension
Cutting tool dimension is enclosed within the packaging
label.
Cooling of Cutting Tools
Synthes strongly recommends the use of cooling fluid to
cool cutting tools.
Implant Removal with Cutting Tools
Implant removal with cutting tools should only be
conducted if no other solution for implant removal exists. Only use diamond coated or carbide cutting tools.
Remove all particles by continuous flushing and vacuuming. Soft tissue must be covered well. Observe the
material composition of the implant.
User Safety
User and OR personal must wear safety goggles.
Disposal of the Cutting Tools
Only dispose contaminated cutting Tools within contaminated hospital waste or decontaminate it.
For further information regarding cutting tools refer to
the Instructions for Use ”Synthes Cutting Tools”
(60121204).
For cleaning and sterilization of cutting tools refer to
”Clinical Processing of Cutting Tools” (036.000.499) for
detailed clinical processing instructions.
For an overview and the ordering information of all cutting tools available refer to the brochure ”Small Bone
Cutting Tools” (DSEM/PWT/1014/0044).
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DePuy Synthes Air Pen Drive
Instructions for Use