Air Pen Drive. Compact drive with specific attachments for a wide

Air Pen Drive. Compact drive
with specific attachments for
a wide spectrum of applications.
Instructions
for Use
This publication is not intended for
distribution in the USA.
Instruments and implants
approved by the AO Foundation
Contents
Introduction
Air Pen Drive System
Attachments
General Information
3
Explanation of Symbols
5
Air Pen Drive
6
Angular Coupling
7
Hand Switch
8
Foot Switch
9
Irrigation
10
General Information
12
Drill Attachments
13
Screw Attachments
15
Kirschner Wire Attachment
16
Saw Attachments
17
Burr Attachments
19
Adapter for Intra Coupling
21
Perforators
22
Craniotome Attachment
24
Air Pen Drive
IInstructions for Use
DePuy Synthes
1
Contents
Cutting Tools
General Information
25
Care and Maintenance
General Information
26
Preparation for Cleaning and Disinfection
27
Cleaning and Disinfection
28
Maintenance and Lubrication
31
Inspection, Packaging, Sterilization and Storage
34
Repairs and Technical Service
35
Disposal
36
Troubleshooting
37
System Specifications
39
Ordering Information
44
Warning
This description alone does not provide sufficient background for direct use
of the product. Instruction by a surgeon experienced in handling this product
is highly recommended.
2
DePuy Synthes
Air Pen Drive
Instructions for Use
Introduction
General Information
Intended use
The Air Pen Drive is an air-driven system to be used for the
treatment in general traumatology, as well as for surgeries in
the areas of the hand, foot, spine, maxillofacial and neurosurgery. Only use Synthes accessories to guarantee operational reliability of the Air Pen Drive.
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.
Safety instructions
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 user of the product is responsible for proper use of the
equipment during surgery.
The Air Pen Drive System is designed for use by physicians
and trained medical personnel.
To ensure proper operation of the tool, Synthes recommends
annual maintenance by a Synthes service center. The manufacturer shall assume no responsibility for damage resulting
from improper operation or unauthorized maintenance of
the tool.
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.
To ensure proper operation of the tool, use only Synthes
original accessories.
Recommended operating pressure: 6 – 8 bar (max 12 bar)
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 “Technique Guide”.
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 ( ).
Check proper operation of the tools before using it on the
patient.
To prevent overheating, always respect the duty cycles for
each attachment listed on page 41.
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.
Air Pen Drive
IInstructions for Use
DePuy Synthes
3
Introduction
General Information
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 APD System can be found in the chapter “Ordering Information”.
For using the APD 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.
For sterilization and storage two system specific Vario Cases
are recommended and available.
For care and maintenance special tools are available, such as
cleaning brushes, Synthes Special Oil for EPD and APD,
Maintenance Spray and Maintenance Unit.
No oils from other manufacturers may be used. Only Synthes
oil may be used.
Storage and transport
Please use the original packaging for dispatch and transport.
If this is no longer available, please contact the Synthes office.
The same environmental conditions apply for transport as for
storage, see page 40.
Warranty
The warranty for the tools and accessories does not cover
damage of any kind resulting from improper use, damaged
seal and improper storage and transport. The manufacturer
does not accept liability for damage resulting from repairs
or maintenance carried out by unauthorized sites.
4
DePuy Synthes
Air Pen Drive
Instructions for Use
Introduction
Explanation of Symbols
Caution
Consult the Instructions for Use before operating
the device.
This symbol indicates that the corresponding device may not be immersed in liquids.
The marked device shall only be used within a
specified temperature range.
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.
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
material 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 protocol.
Even though they may appear undamaged, the
products may have small defects and internal
stress patterns that may cause material fatigue.
Air Pen Drive
IInstructions for Use
DePuy Synthes
5
Air Pen Drive System
Air Pen Drive
Mounting the air hose on the handpiece
The Air Hose 05.001.083 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.
To remove the air hose simply turn the hose coupling piece
and pull it off the handpiece.
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
4
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.
Lock position
2
5
Hand switch position
6 7
Foot switch position
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”.
6
DePuy Synthes
Air Pen Drive
Instructions for Use
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 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)
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.
Air Pen Drive
IInstructions for Use
DePuy Synthes
7
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.
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.
Precautions:
– The angled sections of the handpiece and the Hand
Switch must run parallel with the Hand Switch mounted
(see arrow in picture above).
– Always remove the Hand Switch before sterilization.
8
DePuy Synthes
Air Pen Drive
Instructions for Use
2
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
1
2
Connecting the Foot Switch
Connect a standard Synthes Double Air Hose (519.510
or 519.530) 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)
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.
3
4
5
For assembling the Irrigation Control Unit 4 and Irrigation
Tube, see page 10.
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 1.
Briefly pressing the irrigation button 2 activates or deactivates the irrigation. If the irrigation button 2 is activated,
the irrigation fluid will flow when the pedal 1 is pressed.
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.
Air Pen Drive
IInstructions for Use
DePuy Synthes
9
Air Pen Drive System
Irrigation
Irrigation Control Unit (05.001.090)
Irrigation Tube Set (05.001.069.01S and 05.001.069.05S)
2
Irrigation Tube Set (05.001.178.01S and 05.001.178.05S)
2
Preparing the Irrigation Control Unit
1. Connect the Irrigation Control Unit to the Foot Switch, by
pushing the end of the Air Tube into the plug for the Irrigation Control Unit (see page 9, Position no. 4). Remove
the hand pump of the pressure collar and connect the
pressure collar to the Irrigation Control Unit (Fig. 1).
2. Charge pressure collar with an irrigation fluid bag (Fig. 1).
Fig. 1
10
DePuy Synthes
Air Pen Drive
Instructions for Use
Inserting Irrigation Tube
1. Remove the sterile Irrigation Tube from the sterile package
(Fig. 2).
2. Secure the Irrigation Nozzles on the attachment used, by
pushing the Irrigation Nozzles for the Burr Attachments,
Drill Attachments, Oscillating Saw and Reciprocating Saw
as far as necessary over the attachment from the front.
Push the Irrigation Nozzle for the Sagittal Saw and the
Perforator onto the attachment from the rear (from the
attachment coupling side) before mounting the attachment on the handpiece.
3. First fit the Irrigation Tube on the Irrigation Nozzle used
(Fig. 3), and then turn it around the Air Hose and secure it
with e.g. Hose Holder 519.598 in the unsterile area.
Premounted clips should not be used; those are intended
for use together with the Electric Pen Drive cable.
4. Route the Irrigation Tube end into the non-sterile area
and press the Irrigation Tube in the grooves of the Irrigation Control Unit in accordance with the marking (Fig. 4).
5. Remove the protective cap from the cannula and connect
cannula to Irrigation Bag. When doing so, make sure that
the connection nipple of the cannula is not touched by
non-sterile persons (Fig. 5).
Fig. 2
Fig. 3
1
2
3
4
Fig. 4
Fig. 5
Air Pen Drive
IInstructions for Use
DePuy Synthes
11
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 toward 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.
Removing the attachments from the handpiece
Turn the release sleeve for attachments (see page 6) clockwise until 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.
Precaution: 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.
12
DePuy Synthes
Air Pen Drive
Instructions for Use
Release sleeve
Attachments
Drill Attachments
Drill Attachment (05.001.030–05.001.032,
05.001.042–05.001.044, 05.001.110)
Speed: approx.1,800 rpm at 6.5 bar
1
The Air Pen Drive System includes straight and 45° Drill
Attachments with Mini Quick Coupling, J-Latch Coupling
and AO Coupling, as well as a straight Drill Attachment
with Hexagonal Coupling.
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 drill attachments: approx. 1,800 rpm at 6.5 bar
The cannulation of 1.6 mm permits the use of this attachment for drilling and reaming over K-wires (e.g. for cannulated screws and for cup & cone technique).
1
1 Release sleeve
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.
Air Pen Drive
IInstructions for Use
DePuy Synthes
13
Attachments
Drill Attachments
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 Attachment,
enables 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
With the Oscillating Drill Attachment, tools with a Mini Quick
coupling can be clamped. To do this, lock the unit, pull back
the release sleeve 1 and insert/remove the tool.
14
DePuy Synthes
Air Pen Drive
Instructions for Use
1
1 Release sleeve
Attachments
Screw Attachments
Screw Attachments (05.001.034, 05.001.028,
05.001.029)
Speed: approx. 400 rpm at 6.5 bar
Mounting and removing tools
Lock unit. Pull back the release sleeve and insert/remove the
tool.
1
1 Release sleeve
Precautions:
– Only use the attachment with 6.5 bar to avoid higher
speed than 400 rpm.
– Always use an appropriate torque limiting attachment
while putting locking screws into a locking plate.
– The APD contains no reverse mode for removing screws.
Air Pen Drive
IInstructions for Use
DePuy Synthes
15
Attachments
Kirschner Wire Attachment
Kirschner Wire Attachment (05.001.037)
Speed: approx. 2,700 rpm at 6.5 bar
With the Quick Coupling for Kirschner Wires, Kirschner
Wires of any length with a diameter of 0.6–1.6 mm
(0.02–0.06 in) can be tensioned. The tensioning lever 1
can be rotated by 300°, permitting individual adjustment
suitable for left and right-handed users.
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 regrasp, press the
tensioning lever, pull back the unit along the Kirschner Wire
and then release the tensioning lever again.
16
DePuy Synthes
Air Pen Drive
Instructions for Use
1
1 Tensioning lever
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
2
Sagittal Saw Attachment, centered (05.001.183)
Frequency: approx. 22,000 osc./min at 6.5 bar
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 (45° increments) for
optimum positioning.
4. Release the clamping button.
2
1
1
2
1 Clamping button for saw blades
2 Mounting opening for saw blades
Precautions:
– Saw blades cannot be resharpened.
– Only use Synthes saw blades. The use of other saw blades
voids the device warranty.
Air Pen Drive
IInstructions for Use
DePuy Synthes
17
Attachments
Saw Attachments
Oscillating Saw Attachment (05.001.038)
Frequency: 16,000 osc./min at 6.5 bar
The Oscillating saw attachment is particularly well suited for
crescentic and 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 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
1
Both Synthes reciprocating saw blades and Synthes rasps can
be used with the Reciprocating Saw Attachment.
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.
18
DePuy Synthes
Air Pen Drive
Instructions for Use
1 Release sleeve for saw blades
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 burr for each surgery,
as only then can it be ensured that the burr is always
optimally sharpened and clean. Used tools present the following risks:
– Necrosis due to excess heat
– Infections due to residues
– Longer cutting time due to reduced burr performance
1
1
1 Release sleeve for burrs
Precautions:
– Burrs must be cooled with irrigation liquid to prevent heat
necrosis. For this purpose, use either the foot switch with
the irrigation flow control unit or irrigate manually.
– The attachments may only be used with the burrs intended for this purpose or one size above (see marking S,
M and L on burr and attachment).
– Synthes recommends wearing protective 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.
Air Pen Drive
IInstructions for Use
DePuy Synthes
19
Attachments
Burr Attachments
Drill/Burr Attachment, Straight,
for Round Shafts 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:
– Cutting tools must be cooled with irrigation liquid to prevent heat necrosis. For this purpose, use either the integrated irrigation function or irrigate manually.
– Synthes recommends wearing protective goggles when
working with cutting tools.
– 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
– if applicable, notes, advice and/or warnings in the instructions for use, manuals and/or accompanying documents of the cutting tools or implants must be observed
– please contact the supplier or manufacturer of the
cutting tool if in doubt.
20
DePuy Synthes
Air Pen Drive
Instructions for Use
Information on handling cutting tools
Synthes recommends using a new cutting tool for each surgery, as only then it can be ensured that the cutting tool is
always optimally sharpened and clean. Used tools present
the following risks:
– Necrosis due to excess heat
– Infections due to residues
– Longer cutting time due to reduced tool performance
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).
Note: The Adapter for Intra Coupling cannot be used
with the Electric Pen Drive 90,000 rpm (05.001.011).
Precaution: 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.
Synthes does not assume any liability for misuse of any of
the above mentioned products and consequences that may
result from it.
Air Pen Drive
IInstructions for Use
DePuy Synthes
21
Attachments
Perforators
3
Perforator (05.001.054)
Gear reduction: 97:1
The perforator is used with the related trepan burrs
(03.000.350 –351) including the protective sleeves
(05.001.096 – 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.
Changing trepan burrs
1. Turn the release sleeve for trepan burrs 1 until
the locking pin 2 disengages from the locking groove 3
(Position ).
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 ).
Perforator
05.001.054
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DePuy Synthes
Air Pen Drive
Instructions for Use
2
1
1 Release sleeve for Trepan Burrs
2 Locking pin
3 Locking groove
Fig. 1
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 – 097 on bones
with a thickness of 3 mm or above.
– 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.
– The user is liable for the surgical application.
– Synthes recommends using new cutting tools for every
surgery.
Trepan Burr
03.000.350–351
Protective Sleeve
05.001.096–05.001.097
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.
1
1 Coupling sleeve
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 to cool 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.
– Synthes recommends using a new cutting tool for every
surgery. Please also observe the recommendations of
the supplier of the cutting tool regarding reprocessing /
multiple use.
Air Pen Drive
IInstructions for Use
DePuy Synthes
23
Attachments
Craniotome Attachment
Craniotome Attachment (05.001.059)
and Dura Guards (05.001.051–05.001.053)
Gear ratio: 1:1
1
The system includes a Cranitome Attachment and Dura
Guards in 3 lengths (S, M, L). The related burrs are also
marked with S, M and L.
1 Release sleeve for burrs and Dura Guard
Changing 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 turn the release
sleeve into the LOCK position until it engages to clamp
the burr and the Dura Guard.
6. Check that Dura Guard is well engaged and that Cranial
Burr can be turned freely.
Precautions:
– Only use the Craniotomes with the related Cranial Burrs.
– Cranial Burrs must be cooled with irrigation liquid to avoid
heat necrosis. For this purpose, attach the Irrigation Tube
(05.001.069.01S and 05.001.069.05S) to the nozzle built
into the Dura Guard.
– Only use Synthes Cranial Burrs. The use of other burrs
voids the device warranty.
– Avoid all side load on burr and Dura Guard, as they may
otherwise break.
– 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.
Craniotome Attachment
05.001.059
24
DePuy Synthes
Air Pen Drive
Instructions for Use
Cranial Burr
03.000.124S – 03.000.126S
Dura Guard
05.001.051 – 05.001.053
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
The Small Torx Cutting Tools are indicated for cutting, shaping and smoothing of bones in a wide variety of surgical procedures, including but not limited to general orthopaedic
trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive, and spine surgery
Diamond- and carbide-coated burrs
The Small Torx Cutting Tools with diamond- or carbide-coating are indicated for cutting, shaping and smoothing of
bones, teeth and metal in a wide variety of surgical procedures, including but not limited to general orthopaedic
trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive, and spine surgery.
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.
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 an irrigation nozzle,
the irrigation tube set (see page 14) and 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 carbide or diamond coated 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.
All carbide and diamond coated cutting tools are single use
only.
For cleaning and sterilization of cutting tools refer to “Clinical Processing of Cutting Tools” for detailed clinical processing instructions.
For an overview and the ordering information of all cutting
tools available, refer to the brochure “Cutting Tools for
Electric Pen Drive and Air Pen Drive” (036.000.054).
Air Pen Drive
IInstructions for Use
DePuy Synthes
25
Care and Maintenance
General Information
Power tools and attachments are frequently exposed to high
mechanical loads and shocks during use and should not be
expected to last indefinitely. Proper handling and maintenance help extend the useful life of surgical instruments.
Frequent reprocessing does not have a great effect on the
life of the unit and attachments. Gentle care and maintenance with proper lubrication can substantially increase the
reliability and life of the system components. Synthes recommends annual servicing and inspection by the original manufacturer or its exclusive sales outlets. The manufacturer assumes no warranty for damages arising from improper use
or unauthorized servicing.
Precautions:
– Reprocessing must be performed immediately after each
use.
– Cannulations, unlocking sleeves and other narrow sites require special attention during cleaning.
– Cleaners with a pH 7– 9.5 are recommended. The use of
cleaners with higher pH-values can – depending on the
cleaner – cause a dissolution of the surface of aluminum
and its alloys, plastics or compound materials, they should
only be used considering the data regarding material compatibility according to its data sheet. At pH values higher
than 11 also the surfaces of stainless steel can be affected.
For detailed information about material compatibility, see
“Material Compatibility of Synthes Instruments in Clinical
Processing“ at www.synthes.com. Follow the enzymatic
cleaner or detergent manufacturer’s instructions for use
for correct dilution concentration, temperature, exposure
time and water quality. If temperature and time are not
provided, follow Synthes recommendations. Devices
should be cleaned in a fresh, newlymade solution.
– Detergents used on the products will contact the following materials: stainless steel, aluminum, plastic, and rubber seals.
– Synthes recommends using new sterile cutting tools for
each operation. Refer to “Clinical Processing of Cutting
Tools” for detailed clinical processing instructions.
– Regular oiling of the system components with the Synthes
Maintenance Unit (05.001.099), the Maintenance Spray
(05.001.098) or Synthes Oil (05.001.095) is essential. It
reduces wear and increases the lifespan – especially when
machine washing is used for the products.
26
DePuy Synthes
Air Pen Drive
Instructions for Use
Unusual Transmissible Pathogens
Surgical patients identified as at-risk for Creutzfeldt-Jakob
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.
Important:
– The clinical processing instructions provided have been
validated by Synthes for preparing a non-sterile Synthes
medical device; this instruction is provided in accordance
with ISO 17664:2004 and ANSI / AAMI ST81:2004.
– Consult national regulations and guidelines for additional
information.
– Compliance is additionally required with internal hospital
policies and procedures and recommendations of manufacturers of detergents, disinfectants, and any clinical processing equipment.
– It remains the responsibility of the processor to ensure
that the processing performed achieves the desired result
using the appropriate properly installed, maintained and
validated equipment, materials and personnel in the processing unit.
– Any deviation by the processor from the instructions provided should be properly evaluated.
Care and Maintenance
Preparation for Cleaning and Disinfection
In the operating room
Surface contamination is to be removed with a disposable
cloth or paper cloth.
Fig. 1: Hose couplings
Storage and transport
No special requests, although it is recommended to reprocess
instruments as soon as possible after use.
Preparation for cleaning
– Cleaning must immediately be carried out after each use.
– The handpiece and attachments may not be immersed or
cleaned in an ultrasonic bath.
– Make sure that no cleaning solution enters the air inlet
of the handpiece as well as the inside of the hose
(Figs. 1– 3).
– Do not use pointed objects for cleaning.
– When cleaning the handpiece, do not insert objects into
the air inlet and outlet holes since this would damage the
micro filter.
– The Irrigation Control Unit and the Foot Switch may only
be wiped off with an absorbent cloth.
– Before cleaning and disinfection, all attachments and instruments have to be removed from the handpiece.
– Make sure that the release sleeve is free from residues and
can move properly (Fig. 4).
– Unlock or open instruments to allow for penetration of
cleaning solution.
Fig. 2: Air in-take
Fig. 3: Air in-take
Fig. 4: Release sleeve
Air Pen Drive
IInstructions for Use
DePuy Synthes
27
Care and Maintenance
Cleaning and Disinfection
Manual cleaning and disinfection
1. Separate all system components (handpiece, hand
switch, angled coupling, hoses, attachments, tools) from
each other.
2. Wipe off the Irrigation Control Unit with an absorbent
cloth soaked in disinfectant; do not immerse the Irrigation Control Unit.
3. Wipe off the Foot Switch with an absorbent cloth
soaked in disinfectant. Make sure that no water gets
into the air in-take or air out-let holes. Also make sure
that no water enters the hole in the bottom plate. Do
not immerse the Foot Switch.
4. Plug the air in-/outlet of the drive unit with the Protective
Cap (05.001.086), by inserting the pins of the cap into
the groves of the coupling for hoses and turning the cap
clockwise (Fig. 1). Make sure that the surfaces, which the
Protective Cap will cover, are not contaminated.
5. Before connecting both sides of the Air Hose
(05.001.083, 05.001.084) with the Seal Nipple
(05.001.091) (Fig. 2), make sure that the surfaces, which
the Seal Nipple will cover, are not contaminated. If they
are, first wipe off or spray these surfaces with disinfectant according to the manufacturers instructions, and
then put the Seal Nipple on. Make sure that no solution
enters the hose.
6. Remove coarse residues on the handpiece and the
attachments with a pair of tweezers and/or a cloth. Pay
extra attention to the Sagital and Oscillating Saw Attachments and make sure that all residues are removed
on and in the saw blade couplings.
7. Wipe off or spray the handpiece, attachments and accessory parts with disinfectant and allow the agent to
take effect according to the manufacturer’s instructions.
8. Remove all residues from the disinfected drive unit (use
Protective Cap 05.001.086 to avoid that water enters
the air intake or outlet of the pen), attachments and accessory parts under running cold water with a soft brush
or cloth. When doing so, turn the release sleeve for attachments of the drive unit in the direction of the arrow
to open it.
9. Open the coupling for sawblades of the Sagital Saw
Attachment by pressing the clamping button and clean
the inside of the coupling with a soft brush.
28
DePuy Synthes
Air Pen Drive
Instructions for Use
05.001.086
Fig. 1: Pen with Protective Cap
05.001.091
Fig. 2: See Nipple for Double Air Hose for Air Pen Drive
10. Clean the cannulations of the Quick Coupling for
Kirschner Wires (05.001.037), Drill Attachment 45°,
cannulated, with Jacobs Chuck (05.001.120) and the
Guide for Kirschner Wires for Oscillating Saw Attachment (05.001.121) with the supplied Cleaning Brush
(05.001.075, Fig. 3). Flush the inner lumen of irrigation
nozzles with a syringe using cold tap water.
11. Wipe the unit and accessories with an absorbent cloth
to dry them.
12. The adapters for Schrader-/Synthes Coupling and
Dräger-/Synthes Coupling also have to be cleaned when
needed, to assure full performance of the system.
Fig. 3: Cleaning Brush
Air Pen Drive
IInstructions for Use
DePuy Synthes
29
Care and Maintenance
Cleaning and Disinfection
Automated cleaning and disinfection
(Validated with Miele G 7735 CD, Program Vario TD;
Detergent: Neodisher Midizym, DECONNEX 23 Neutraclean,
DECONNEX 23 Neutrazym)
1. Do not machine wash the Irrigation Control Unit and the
Foot Switch. See Manual Cleaning and Disinfection on
page 28 (point 2 and 3).
2. Plug the air inlet of the drive unit with the protective cap
(05.001.086) (Fig. 1, page 28). Make sure that the surfaces, which the Protective Cap will cover, are not contaminated.
3. Before connecting both sides of the Air Hoses
(05.001.083, 05.001.084) with the Seal Nipple
(05.001.091), make sure that the surfaces, which the
Seal Nipple will cover, are not contaminated. If they are,
first wipe off or spray these surfaces with disinfectant
according to the manufacturers instructions, and then
put the Seal Nipple on. Make sure that no solution
enters the hose (Fig. 2, page 28).
4. Manually clean critical sites such as cannulations, unlocking sleeves, lumen of irrigation nozzles and other
difficult-to-reach locations as described on page 28,
points 8 and 9.
5. Position the devices in the washing machine so that
dead zones do not arise and the water can properly
drain.
6. Pre-rinse with cold water.
7. Wash with detergents according to the instructions of
the detergent manufacturer.
8. Rinse with tap water and then with cold demineralized
water.
9. Thermally disinfect with demineralized water at 92°.
10. Dry with hot air at 90°.
11. Upon removing the instruments, remove the Seal Nipple
and the Protective Cap and inspect the cannulations,
coupling sleeves, etc. for visible soiling. If necessary, repeat the cycle or clean manually.
30
DePuy Synthes
Air Pen Drive
Instructions for Use
Precautions:
– For automated cleaning, also consult the brochure
“Synthes Power Tools. Machine Washing Recommendations” (036.000.101).
– Drive units (especially seals and bearings) are exposed to
greater stress during machine washing than when they
are cleaned manually. For this reason, drive units must be
regularly sent for service (at least once per year) when
they are machine washed.
– The use of other cleaning and disinfecting methods is
possible. Have an expert check the effectiveness under
local conditions.
– The use of other detergents and disinfectants is possible.
Clarify the material compatibility and effectiveness beforehand with the detergent or disinfectant manufacturer.
Care and Maintenance
Maintenance and Lubrication
Maintenance – with the Synthes Maintenance Unit
Synthes recommends the use of the Synthes Maintenance
Unit (05.001.099) developed for oiling of handpiece and attachments. With the Maintenance Unit an optimal maintenance of the system over the entire service life can be ensured. The operation of the Maintenance Unit is explained in
the related Instructions for Use (036.000.098).
For attaching the Air Pen Drive to the Maintenance Unit, the
Adapter for Maintenance Unit for Air Pen Drive 05.001.089,
has to be used. The pen must be on position foot switch during oiling.
Maintenance Unit,
05.001.099
Adapter for Maintenance
Unit, for Air Pen Drive
05.001.089
It is recommended to apply Synthes Special Oil 05.001.095
for Electric and Air Pen Drive after each use or when needed,
on movable parts on the handpiece as described in the chapter entitled “Maintenance – manually”.
Precaution: The Air Pen Drive has to be oiled through the air
in-/outlet, not through the front.
Air Pen Drive
IInstructions for Use
DePuy Synthes
31
Care and Maintenance
Maintenance and Lubrication
Maintenance – manually
Oiling the handpiece – with Maintenance Spray
05.001.098
1. Perform maintenance on the handpiece following every
use with the Synthes Maintenance Spray (05.001.098)
and Oiling Adapter for Air Pen Drive (05.001.092). The
pen must be on foot switch position.
2. Push the spray over the air in-take part and briefly actuate
it once (approx. 1 sec.). When doing so, wrap the adapter
for Air Pen Drive (05.001.092) with a cloth to catch excess
oil, or hold it over a washbasin. Always spray away from
the body.
3. Remove the excess oil with a cloth after spraying.
It is recommended to apply Synthes Special Oil 05.001.095
for Electric and Air Pen Drive after each use or when needed,
on movable parts on the handpiece as described on the next
page.
Oiling the attachments
1. Perform maintenance on the attachments following every
use with the Synthes Maintenance Spray (05.001.098)
and oiling Adapter for Attachments for Maintenance
Spray (05.001.102).
2. Push the spray over the attachment coupling and briefly
actuate it once (approx. 1 sec.). When doing so, wrap the
attachments with a cloth to catch excess oil, or hold over
a washbasin. Always spray away from the body.
3. Remove the excess oil with a cloth after spraying.
32
DePuy Synthes
Air Pen Drive
Instructions for Use
Maintenance of movable parts on handpiece
and Foot Switch – with Synthes special oil (05.001.095)
Apply Synthes special oil 05.001.095 for Electric and Air Pen
Drive after each use or when needed, on movable parts on
the handpiece and the Foot Switch.
1
3
2
Oiling movable parts of the handpiece
Apply one drop of oil in the slots between the adjustment
sleeve 1 and the basic body, one drop of oil in the slots
behind the release sleeve 2 and move the sleeves. To oil the
valve 3 of the handpiece first set the handpiece on Hand
Switch position. Then drop one drop of oil on the valve and
connect the Hand Switch to the handpiece. Operate the
Hand Switch by moving it up and down. Make sure that the
valve opens and closes and that oil get into the valve. If
necessary, repeat the oiling procedure. Finish by wiping off
excess oil from the handpiece.
Oiling movable parts of the Foot Switch
If the connections for air hoses and irrigation do not move
smoothly please drop 2 drops of Synthes special oil
05.001.095 on each connection and move them to spread
the oil.
Precaution: Only use the Synthes Maintenance Spray
(05.001.098) or/and Synthes Electric and Air Pen Drive Oil
(05.001.095). Their biocompatible composition matches the
requirements for power tools in the operating room. Lubricants with other compositions may lead to sticking and could
have a toxic effect.
Air Pen Drive
IInstructions for Use
DePuy Synthes
33
Care and Maintenance
Inspection, Packaging, Sterilization
and Storage
Inspection and function check
1. Carry out a visual inspection to see if the products are
damaged or worn out.
2. Check function and movement of the operating elements
(adjustment sleeve and release sleeve of the pen as well
as couplings of the attachments).
3. Synthes recommends replacing all cutting tools after each
use.
Packaging
Put cleaned, dry products into the proper places in the
Synthes Vario Case (68.000.020 or 68.000.030). Additionally,
use an appropriate sterilization wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System
according to ISO 11607. Care should be taken to protect
implants, and pointed and sharp instruments from contact
with other objects that may damage the surface or the
Sterile Barrier System.
Sterilization
(Validated with AD Linden 3/3/6 DECE).
Note: Remove the Seal Nipple for Double Air Hose for Air
Pen Drive (05.001.091) and the Protective Cap (05.001.086)
from the Air Pen Drive before sterilization.
We recommend a sterilization program including a
prevacuum method with the following parameters:
– Temperature: 134 °C
– Plateau time: 3 minutes
– Dry times generally range from 20 to 60 minutes due to
differences in packaging materials (Sterile Barrier System,
e.g., wraps or re-usable rigid container systems), steam
quality, device materials, total mass, sterilizer performance
and varying cool-down time.
– After sterilization, the handpiece should only be used
again when it has cooled down to room temperature. The
cooling process must not be accelerated.
For information on the reprocessing of Synthes cutting tools please see the
brochure “Clinical Processing of Cutting Tools” (036.000.499)
34
DePuy Synthes
Air Pen Drive
Instructions for Use
Precautions:
– The following sterilization parameters must not be
exceeded:
– Temperature 143 °C (289.4 °F) during a maximum of
22 minutes. Higher values will damage the products.
– The Foot Switch and the Irrigation Control Unit must not
be sterilized.
– The handpiece, the attachments and other accessories
(hose,tools, hand switch etc.) must not be assembled
during sterilization.
– Remove the Hand Switch for sterilization. If this is not
done, the function of the Hand Switch can be damaged!
– Hot air, ethylene oxide, plasma and formaldehyde sterilization are not recommended.
– Synthes recommends using a new sterile cutting tool for
each surgery.
Detailed cleaning and sterilization instructions can be found
in the general leaflet “Important Information” or for download in the section “Reprocessing, Care & Maintenance” at
www.synthes.com.
Storage
Storage conditions for products labeled “STERILE” are
printed on the packaging label.
Packaged and sterilized products should be stored in a dry,
clean environment, protected from direct sunlight, pests,
and extremes of temperature and humidity. Use products in
the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label.
Care and Maintenance
Repairs and Technical Service
The tool should be sent to the Synthes office for repair if it is
faulty or malfunctions.
If a device drops, it has to be sent in for service.
Faulty devices may not be used. If it is no longer possible or
feasible to repair the tool it should be disposed of, cf. the
following chapter “Disposal”.
Other than the above mentioned care and maintenance, no
further maintenance work can be carried out independently
or by third parties.
Synthes recommends that the device and accessories such as
attachments are regularly (once a year) serviced by the original manufacturer or an authorized site.
Precaution: The manufacturer shall assume no responsibility
for damage resulting from unauthorized maintenance.
Air Pen Drive
IInstructions for Use
DePuy Synthes
35
Care and Maintenance
Disposal
In most cases, faulty tools can be repaired (cf. previous chapter “Repairs and Technical Service”).
Precaution: Contaminated products have to run through
the complete reprocessing procedure, so that there is
no danger of infection in case of disposal.
Please send tools that are no longer used to the local Synthes
representative. This ensures that they are disposed of in accordance with the national application of the respective directive. The tool may not be disposed of with household
waste.
36
DePuy Synthes
Air Pen Drive
Instructions for Use
Troubleshooting
Problem
Possible causes
Remedy
Pen does not start up.
Adjustment sleeve on pen is set to LOCK
position.
Set adjustment sleeve to HAND or FOOT
switch position.
Release sleeve for burr on burr attachment set to UNLOCK position.
Set release sleeve on burr attachment
to LOCK position.
Hand Switch turned 180°.
Turn Hand Switch 180° and fit as described in the chapter Hand Switch.
Hand Switch cannot work because Foot
Switch is shutting off air supply.
Remove Foot Switch and connect the
handpiece directly to the air power supply or use the Foot Switch.
Adjustment sleeve is in the position
HAND or LOCK while trying to work with
the Foot Switch.
Set adjustment sleeve to position FOOT.
Safety switch on Hand Switch is in LOCK
position.
Set safety switch to ON position.
Operating pressure too low.
Set operating pressure on pressure
regulator to 6–8 bar.
Micro filter blocked.
Exchange micro filter in the central air
supply.
Air inlet is blocked.
Remove solid objects from the air inlet
with tweezers. Important: Do not use
piercing objects to do this. Lock the drive
when removing objects.
Hose is too long.
Check that the entire length of hose does
not exceed 8 m.
Hose couplings defective.
Check wall and drive hose couplings for
tightness.
Central air supply
tubes are obstructed.
Check central air supply.
Drive has not enough power.
Air Pen Drive
IInstructions for Use
DePuy Synthes
37
Troubleshooting
Problem
Possible causes
Remedy
Pen runs at full speed all the time.
Adjustment sleeve is in the position FOOT
without having a foot switch attached.
Set adjustment sleeve in position HAND
or LOCK.
Attachments cannot be coupled to unit.
Attachment coupling is blocked
by deposits.
Remove solid objects with a pair of
tweezers. Attention: When removing
objects, set unit to OFF.
Attachment or tool (saw blade, drill, burr
etc.) cannot be coupled or only with
difficulty.
Movable parts have not been maintained.
Oil the movable parts.
Tool (saw blade, drill, burr etc.) cannot be
coupled or only with difficulty.
Shaft geometry of tool damaged.
Replace tool or send to your Synthes
service office.
Bones and tool heat up due to working
process.
Cutting edges of tool are dull.
Replace tool.
No irrigation has been used.
Use irrigation.
If the recommended remedies are unsuccessful,
please contact your Synthes service center.
38
DePuy Synthes
Air Pen Drive
Instructions for Use
System Specifications
Technical Data
Pen
Weight:
169 g / 5.96 oz
Length:
144 mm / 5.7 in
Recommended
Pressure:
6–8 bar
For maximum 10 minutes (continuous
operation) it is possible to run the Air Pen
Drive up to 12 bar with the following
attachments: 05.001.045–05.001.050,
05.001.054, 05.001.059, 05.001.055.
Continuously
variable speed:
0–60,000 rpm at 6.5 bar
0–80,000 rpm at 12 bar (only with
05.001.045–05.001.050, 05.001.054,
05.001.059, 05.001.055)
Foot Switch
Dimensions:
267 mm160 mm47 mm
(bar included 151 mm)
10.5 in6.3 in1.9 in
(bar included 5.9 in)
Precautions:
– The Air Pen Drive must never be operated with oxygen,
due to danger of explosion. The Air Pen Drive should also
not be stored or operated in an explosive atmosphere.
– Dirt inside e.g. adapters, air hoses, angular coupling and
pen can cause loss of power.
Air Pen Drive
IInstructions for Use
DePuy Synthes
39
System Specifications
Environmental conditions
Operation
Temperature
Storage
40 °C
104 °F
10 °C
50 °F
Relative humidity
–20 °C
–– 4 °F
30 %
DePuy Synthes
75 %
1060 hPa
1.06 bar
Air Pen Drive
Instructions for Use
50 °C
122 °F
–20 °C
–4 °F
10 %
500 hPa
0.5 bar
40
50 °C
122 °F
75 %
Atmospheric pressure
Transport
75 %
10 %
1060 hPa
1.06 bar
500 hPa
0.5 bar
1060 hPa
1.06 bar
500 hPa
0.5 bar
Duty cycles
To prevent overheating, always respect the duty cycles for
each attachment listed below.
Intermittent operation
with 6.5 bar
Xmin on
Ymin off
Cycles
Drilling Attachments
5 min
3 min
15 cycles
Burr Attachments
unlimited
–
15 cycles
Craniotome Attachment 1 min
30 s
Perforation
5 min
3 min
15 cycles
Reciprocating
Saw Attachment
3 min
2 min
15 cycles
Oscillating
Saw Attachment
1 min
2 min
15 cycles
Sagittal
Saw Attachment
1 min
2 min
15 cycles
Intermittent operation
with12 bar*
Xmin on
Ymin off
Cycles
Burr Attachment
15 min
10 min
2 cycles
Craniotome Attachment 1 min
30 s
5 cycles
Perforator
5 min
3 min
5 cycles
These recommendations for times of use for the attachments
for Air Pen Drive have been determined under average load
with an ambient air temperature of 20 °C (68 °F). Generally
systems can heat up if in constant use. For this reason the
handpiece and the attachment should be allowed to cool
down for the above recommended periods of constant use.
If this is observed the system will be prevented from overheating and possibly harming the patient or user. After the
above indicated number of cycles, the respective attachments must be allowed to cool down for 30 minutes. The
user is responsible for the application and for turning off the
system as prescribed. If longer periods of constant use are
required, an additional handpiece and /or attachment should
be used. For oral surgery it is recommended to prevent any
contact of warm components with soft tissues as already
temperatures around 45 °C may damage the lips and oral
mucosa.
Precautions:
– Carefully observe the above recommended duty cycles.
– Always use new cutting tools to prevent heating up of the
system due to reduced cutting performance.
– Careful maintenance of the system will reduce heat development in the handpiece and the attachments. The use of
the maintenance unit (05.001.099) is strongly recommended.
15 cycles
* For maximum 10 minutes.
Air Pen Drive
IInstructions for Use
DePuy Synthes
41
System Specifications
Declaration of the emission sound pressure level and the sound power level according to
the EG guideline 2006/42/EG Annex I
Sound pressure level [LpA] in accordance with the norm EN ISO 11202
Sound power level [LwA] in accordance with the norm EN ISO 3746
Handpiece
Attachment
Cutting tool
Sound Pressure
Level
(LpA) in [dB(A)]
Sound Power
Max. daily
Level
exposure time
(LwA) in [dB(A)] without hearing
protection
APD 05.001.080
–
–
78
–
>8 h
Drill Attachment
AO/ASIF
05.001.032
–
76
–
>8 h
Oscillating
Saw Attachment
05.001.038
Saw blade
03.000.313
79
89
>8 h
Saw blade
03.000.316
78
88
>8 h
Sagittal
Saw Attachments
05.001.039
05.001.182
05.001.183
Saw blade
03.000.303
75
87
>8 h
Saw blade
03.000.315
81
90
>8 h
Reciprocating
Saw Attachment
05.001.040
Saw blade
03.000.321
80
88
>8 h
Saw blade
03.000.330
79
88
>8 h
Burr
03.000.017
71
88
>8 h
Burr
03.000.108
72
89
>8 h
Burr Attachment
05.001.055
42
DePuy Synthes
Air Pen Drive
Instructions for Use
Declaration of vibration emissions according to EU Directive 2002/44/EC
Vibration emissions [m/s2] according to EN ISO 5349-1.
Handpiece
Attachment
Cutting tool
Declaration
[m/s2]
Max. daily exposure
time to reach action
value [2.5 m/s2]
APD 05.001.080
–
–
< 2.5
no limitation
Drill Attachment
AO/ASIF
05.001.032
–
< 2.5
no limitation
Oscillating Saw
Attachment
05.001.038
Saw blade
03.000.313
7.8
3 h 20 min
Saw blade
03.000.316
9.7
2 h 7 min
Sagittal Saw
Attachments
05.001.039
05.001.182
05.001.183
Saw blade
03.000.303
3.14
5 h 4 min
Saw blade
03.000.315
16.39
Reciprocating Saw
Attachment
05.001.040
Saw blade
03.000.321
4.1
no limitation
Saw blade
03.000.330
4.4
no limitation
Burr
03.000.017
0.91
no limitation
Burr
03.000.108
0.64
no limitation
Burr Attachment
05.001.055
Air Pen Drive
11 min
IInstructions for Use
DePuy Synthes
43
Ordering Information
Handpiece
05.001.080
Attachments for 05.001.080
Air Pen Drive 60.000 rpm
Foot Switch
05.001.081
Foot Switch, for Air Pen Drive
Hand Switch
05.001.082
Hand Switch, for Air Pen Drive
Hose and accessories
05.001.083
Double Air Hose, length 3 m, for Air Pen Drive
05.001.084
Double Air Hose, length 5 m, for Air Pen Drive
519.510
Double Air Hose, length 3 m, for System Synthes
519.530
Double Air Hose, length 5 m, for System Synthes
05.001.085
Angular Coupling, for Air Pen Drive
05.001.090
Irrigation Control Unit, for Air Pen Drive
05.001.091
Seal Nipple for Double Air Hose, for Air Pen Drive
05.001.086
Protective Cap, for Air Pen Drive
05.001.087
Adapter for Schrader/Synthes Coupling
05.001.088
Adapter for Dräger/Synthes Coupling
44
DePuy Synthes
Air Pen Drive
Instructions for Use
05.001.030
Drill Attachment with Mini Quick Coupling
05.001.031
Drill Attachment with J-Latch Coupling
05.001.032
AO/ASIF Drill Attachment
05.001.110
Drill Attachment with Hexagonal Coupling
05.001.033
Oscillating Drill Attachment 45°, with Mini Quick Coupling
05.001.042
Drill Attachment 45°, with Mini Quick Coupling
05.001.043
Drill Attachment 45°, with J-Latch Coupling
05.001.044
AO/ASIF Drill Attachment 45°
05.001.120
Drill Attachment 45°, cannulated, with Jacobs Chuck
05.001.035
Drill Attachment 90°, short, with Mini Quick Coupling
05.001.036
Drill Attachment 90°, long, with Mini Quick Coupling
05.001.028
Screw Attachment, with AO/ASIF Quick Coupling
05.001.029
Screw Attachment, with Hexagonal Coupling
05.001.034
Screw Attachment, with Mini Quick Coupling
05.001.037
Kirschner Wire Attachment
05.001.038
Oscillating Saw Attachment
05.001.039
Sagittal Saw Attachment
05.001.183
Sagittal Saw Attachment, centred
05.001.182
Sagittal Saw Attachment, 90°
05.001.040
Reciprocating Saw Attachment
05.001.045
Burr Attachment, S
05.001.046
Burr Attachment, M
05.001.047
Burr Attachment, L
05.001.048
Burr Attachment, S, angled
05.001.049
Burr Attachment, M, angled
05.001.050
Burr Attachment, L, angled
05.001.063
Burr Attachment, XL, 20°
05.001.055
Burr Attachment, XXL, 20°
05.001.059
Craniotome Attachment
05.001.051
Dura Guard, S, for Craniotome Attachment No. 05.001.059
05.001.052
Dura Guard, M, for Craniotome Attachment No. 05.001.059
05.001.053
Dura Guard, L, for Craniotome Attachment No. 05.001.059
05.001.054
Perforator
05.001.177
Perforator, with Hudson Coupling
05.001.096/S
Protection Sleeve for Trepan Burr 7.0 mm
05.001.097/S
Protection Sleeve for Trepan Burr 12.0 mm
03.000.350/S
Trepan Burr 7.0 mm
03.000.351/S
Trepan Burr 12.0 mm
05.001.123
Drill/Burr Attachment, straight, for Round Shafts 2.35 mm
05.001.103
Adapter for Intra Coupling
Accessories
Cases
05.001.121
Guide for Kirschner Wire, for Oscillating Saw
05.001.066
Irrigation Nozzle, short, for Nos. 05.001.045 and 05.001.048
05.001.067
Irrigation Nozzle, medium, for Nos. 05.001.046 and 05.001.049
05.001.068
Irrigation Nozzle, long, for Nos. 05.001.047 and 05.001.050
05.001.065
Irrigation Nozzle, for No. 05.001.063
05.001.122
05.001.111
68.000.020
Vario Case, size 1/1, height 88 mm, for Air Pen Drive,
without Lid, without Contents
68.000.030
Vario Case, size 1/1, height 126 mm, for Air Pen Drive,
without Lid, without Contents
68.000.004
Insert, size 1/2, for Basic Instruments, for Vario Case
No. 68.000.000
Irrigation Nozzle, for angled Burr Attachment XXL
No. 05.001.055
68.000.005
Insert, size 1/4, for Spine, for Vario Case No. 68.000.000
Irrigation nozzle, for Drill Attachments Nos. 05.001.030,
05.001.031, 05.001.032 and 05.001.110
68.000.006
Insert, size 1/4, for Neuro, for Vario Case No. 68.000.000
689.507
Lid (stainless steel), size 1/1, for Vario Case
05.001.070
Irrigation Nozzle, for Sagittal Saw Attachment No. 05.001.039
05.001.185
Irrigation Nozzle, for No. 05.001.183
05.001.184
Irrigation Nozzle, for Sagittal Saw Attachment, 90°,
No. 05.001.182
05.001.071
Irrigation Nozzle, for Reciprocating Saw Attachment
No. 05.001.040
05.001.076
Irrigation Nozzle, for Perforator No. 05.001.054
05.001.180
Irrigation Nozzle, for Perforator with Hudson Coupling
05.001.177
Cutting Tools
For ordering informations for the Air Pen Drive Cutting Tools refer to the brochure
“Cutting Tools for Electric Pen Drive and Air Pen Drive” (036.000.054).
05.001.178.01S Irrigation Tube Set, for EPD and APD, sterile, single pack
05.001.178.05S Irrigation Tube Set, for EPD and APD, sterile, pack of 5 units
05.001.098
Synthes Maintenance Spray, 400 ml
05.001.098.06 Synthes Maintenance Spray, 400 ml (6 units)
05.001.099
Maintenance Unit
05.001.094
Refill Set for Maintenance Unit
05.001.095
Synthes Maintenance Oil, 40 ml
05.001.092
Adapter for APD Handpiece,
for Maintenance Spray No. 05.001.098
05.001.102
Adapter for EPD/APD Attachments,
for Maintenance Spray No. 05.001.098
05.001.089
Adapter for Maintenance Unit No. 05.001.099, for Air Pen Drive
05.001.064
Adapter for Maintenance Unit, for Nos. 05.001.055 and
05.001.063
05.001.074
Handle for Change of Instruments, for EPD/APD Attachments
68.000.007
Support for Cutting Tools with shaft 2.3 and 3.2 mm
05.001.075
Cleaning Brush for 05.001.037
519.598
Hose Holder, pack of 2 units
310.932
Spare Key for Drill Chuck, clamping range up to 4.0 mm
Air Pen Drive
IInstructions for Use
DePuy Synthes
45
46
DePuy Synthes
Air Pen Drive
Instructions for Use
Air Pen Drive
IInstructions for Use
DePuy Synthes
47
48
DePuy Synthes
Air Pen Drive
Instructions for Use
Synthes and Vario Case are trademarks of Synthes, Inc. or its affiliates
Subject to modifications
© Synthes, Inc. or its affiliates
40100136
04/2013
This publication is not intended for distribution in the USA.
All technique guides are available as PDF files at
www.synthes.com/lit
0123
50182279
SE_036268 AD
Synthes GmbH
Eimattstrasse 3
CH-4436 Oberdorf
www.synthes.com
036.000.503
Ö036.000.503öAD(ä
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