Johnson & Johnson DePuy Synthes Electric Pen Drive User manual

Compact drive with specic attachments for a wide spectrum of applications
Air Pen Drive
Instructions for Use

Air Pen Drive Instructions for Use DePuy Synthes 1
Introduction General Information 3
Explanation of Symbols 5
Air Pen Drive System Air Pen Drive 6
Angular Coupling (05.001.085) 8
Hand Switch (05.001.082) 9
Foot Switch (05.001.081) 10
Attachments 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
Cutting Tools General Information 24
Table of Contents

2 DePuy Synthes Instructions for Use Air Pen Drive
Care and Maintenance General Information 25
Cleaning and Disinfection 26
• Preparation Prior to Reprocessing 26
• Manual Cleaning Instructions 27
• Automated Cleaning Instructions
with Manual Pre-cleaning 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
Table of Contents

Air Pen Drive Instructions for Use DePuy Synthes 3
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 surger-
ies 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
”Synthes Implant Instructions for Use” 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 physi-
cians and trained medical personnel.
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 ammable anes-
thetic and air. Never use oxygen to run air-powered sys-
tems (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 Specication)
Only use original Synthes hoses for compressed air.
Before rst and every use, power tools and their acces-
sories/attachments have to run through the complete
reprocessing procedure. Protective covers and foils must
be fully removed before sterilization.
Check instruments for correct adjustment and function-
ing prior to every use.
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 accor-
dance with the process recommended in the chapter
”Care and Maintenance”. Compliance with these speci-
cations can considerably extend the service life of the
tool. Only use Synthes Maintenance Oil for EPD/APD,
40 ml or Synthes Maintenance Spray 400 ml to lubricate
the tool.
Efciently working cutting tools are the basis for suc-
cessful 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.
If the Air Pen Drive System is used in conjunction with
an implant system make sure to consult the correspond-
ing ”Synthes Implant Instructions for Use”.
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 identied as at-risk for Creutzfeldt-
Jakob disease (CJD) and related infections should be
treated with single-use instruments. Dispose of instru-
ments used or suspected of use on a patient with CJD
after surgery and/or follow current national recommen-
dations.

4 DePuy Synthes Instructions for Use Air Pen Drive
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 oor and have
visible defects, do not use it anymore and send it to
the Synthes service center.
• If a product drops on the oor, fragments may split
off. This represents danger for the patient and user
as:
• these fragments may be sharp.
• unsterile fragments may enter the sterile eld or
hit the patient.
Accessories/Scope of delivery
The main components in the APD System are the hand-
piece, Hand Switch, Foot Switch, Air Hose as well as at-
tachments and accessories. An overview of all compo-
nents belonging to the Air Pen Drive System can be
found in the chapter ”Ordering Information”.
For using the Air Pen Drive System the following compo-
nents 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 tting to the attachment
For an optimal function of the system only Synthes cut-
ting tools shall be used.
Synthes recommends the use of the specically designed
Synthes Vario Cases and of the specically designed
Washing Basket (68.001.800) to sterilize and store the
system.
For care and maintenance special tools are available,
such as cleaning brushes, Synthes Maintenance Oil
forEPD and APD (05.001.095), Maintenance Spray
(05.001.098) and Maintenance Unit (05.001.099).
No oils from other manufacturers may be used. Only
Synthes Maintenance Oil for EPD/APD, 40 ml or Synthes
Maintenance Spray 400 ml 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. How-
ever, if a Power Tool or accessory/attachment breaks
during use, a visual inspection or a medical imagine de-
vice (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 trans-
port. If the packing material is no longer available,
please contact the Synthes ofce. For storage and trans-
port 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 mainte-
nance or servicing of the tool.
For further information on the warranty please contact
your local Synthes ofce.

Air Pen Drive Instructions for Use DePuy Synthes 5
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 direc-
tive 93/42/EEC for medical devices. It is au-
thorized by an independent notied body for
which it bears the CE symbol.
Locked symbol. Drive Unit is off for safety.
Legal manufacturer
Manufacturing date
Non sterile
Temperature limitations
Relative humidity
Atmospheric pressure
Do not use if package is damaged.
2
Do not reuse
Products intended for single use must not be
reused.
Reuse or reprocessing (e.g. cleaning and
resterilization) may compromise the §struc-
tural integrity of the device and/or lead to de-
vice failure, which may result in patient injury,
illness or death. Furthermore, reuse or repro-
cessing 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 uids/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.
Reference number
Lot number
Serial number
Packaging unit ISO 7000-2794 (2009-02)
Expiration date
INMETRO Ord. 350 certied

3
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6 DePuy Synthes Instructions for Use Air Pen Drive
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
tting 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 dis-
connect 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

4 5 6 7
Air Pen Drive Instructions for Use DePuy Synthes 7
Adjustment sleeve
To avoid an unintentional change of the operating mode
thelock slide for adjustment sleeve 7 locks the adjust-
ment sleeve automatically. To be able to move the
adjustment sleeve the lock slide has to be pushed back-
wards. After having reached the desired position release
the lock slide and the adjustment sleeve is locked in the
desired 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 acciden-
tal 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!
Lock position Hand switch position Foot switch position

8 DePuy Synthes Instructions for Use Air Pen Drive
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 t-
ting 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 Angu-
lar Coupling by tting 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- clock-
wise and pull the Air Hose offthe Angular Coupling, and
then the Angular Coupling off the handpiece.

25
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Air Pen Drive Instructions for Use DePuy Synthes 9
Air Pen Drive System
Hand Switch (05.001.082)
1 Positioning arrow
2 Pull-out nger rest
3 Positioning arrow
4 Guide groove
5 Locking switch
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 posi-
tioning arrows 3 over the guide grooves 4 of the pen.
Then press downward vertically until the Hand Switch
clicks into position.
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 ad-
justed with the pull-out nger rest 2. The speed can be
continuously adjusted by operating the Hand Switch. The
Hand Switch can be deactivated (LOCK position) or acti-
vated (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.

1
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4
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10 DePuy Synthes Instructions for Use Air Pen Drive
Air Pen Drive System
Foot Switch (05.001.081)
1 Pedal
2 Irrigation ON/OFF button*
3 Plug for Double Air Hose
4 Plug for Irrigation Control Unit*
5 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 Dou-
ble 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 con-
nected! 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

Air Pen Drive Instructions for Use DePuy Synthes 11
Attachments
General Information
Mounting the attachments on the handpiece
The attachments can be connected in 8 different posi-
tions (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 hand-
piece 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 up-
ward while doing so. Then remove the attachment.
Attachments and accessories
For easier change of burrs, without having the Burr
Attachment or Cranio tome 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.
Release sleeve

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1
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12 DePuy Synthes Instructions for Use Air Pen Drive
Attachments
Drill Attachments
Drill Attachments (05.001.030–05.001.032,
05.001.044)
Speed: approx. 1,800 rpm at 6.5 bar
The system includes straight Drill Attachments with Mini
Quick, J-Latch and AO/ASIF Coupling and a 45° cannu-
lated AO/ASIF Drill Attachment.
The 45° Drill Attachment with AO/ASIF Coupling
(05.001.044) has a cannulation of 1.6 mm, which per-
mits the use of this attachment for drilling and reaming
over Kirschner Wire (e.g. for cannulated screws and for
cup and cone technique).
Mounting and removing tools
Lock unit. Pull back the release sleeve and insert/remove
the tool.
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 coun-
terclockwise and tighten it by turning the key clockwise.
1 Release sleeve
1 Release sleeve

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Air Pen Drive Instructions for Use DePuy Synthes 13
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 Attach-
ments 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.
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 oper-
ating 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 Slide
1 Release sleeve

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14 DePuy Synthes Instructions for Use Air Pen Drive
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 de-
vice while inserting locking screws into a locking
plate.
• The APD contains no reverse mode for removing
screws.
1 Release sleeve

1
Air Pen Drive Instructions 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 Kirschner Wire Attachment, Kirschner Wires of
any length with a diameter of 0.6–1.6 mm can be ten-
sioned. 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 re-grasp,
press the tensioning lever, pull back the unit along the
Kirschner Wire and then release the tensioning lever
again.
1 Tensioning lever

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2
2
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16 DePuy Synthes Instructions for Use Air Pen Drive
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 cut-
ting 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
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.
1 Clamping button for saw blades
2 Mounting opening for saw blades

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Air Pen Drive Instructions for Use DePuy Synthes 17
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 re-
move 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 at-
tachment from the front, so that it engages in the shape
of the Oscillating Saw.
Then mount the attachment on the handpiece.
Note: No irrigation nozzle is available for the oscil-
lating 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.
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.
1 Release sleeve for saw blades
2 Mounting opening for saw blades
Kirschner Wire B 1.6 mm
1 Release sleeve for saw blades

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18 DePuy Synthes Instructions for Use Air Pen Drive
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 Attach-
ments 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 Hand-
hold (05.001.074) for easier change of burrs.
1 Release sleeve for burrs