DePuy Synthes Air Pen Drive 05.001.082 Instructions for Use March 2018

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Compact drive with specific attachments for a wide spectrum of applications

Air Pen Drive

Instructions for Use

Page 4

Table of Contents

Care and Maintenance

General Information

25

Cleaning and Disinfection

• Preparation Prior to Reprocessing

• Manual Cleaning Instructions

• Automated Cleaning Instructions

with Manual Pre-cleaning

26

26

27

29

Maintenance and Lubrication

33

Function Control

36

Packaging, Sterilization and Storage

37

Repairs and Technical Service

38

Disposal

39

Troubleshooting

40

System Specifications

42

Ordering Information

47

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DePuy Synthes Air Pen Drive

Instructions for Use

Page 5

Introduction

General Information

Intended use

The Air Pen Drive is an air-driven system to be used for

treatment in general traumatology, as well as for surgeries in the areas of the hand, foot, spine, maxillofacial

and neurosurgery.

Safety instructions

The surgeon has to evaluate if the machine is suitable

for an application, based on power limitation of the

­machine, attachment and cutting tool regarding bone

strength/anatomical situation as well as handling of the

machine, attachment and cutting tool regarding bone

size. In addition, the contraindications of the implant

have to be respected. Please refer to the corresponding

”Surgical Techniques” of the implant system used.

The Air Pen Drive System is only to be used for patient

treatment after careful consultation of the instructions

for use. It is recommended that an alternative system is

available to use during application, as technical problems

can never be completely ruled out.

The Air Pen Drive System is designed for use by physicians and trained medical personnel.

Always wear personal protective equipment (PPE)

including safety goggles when handling with the Air

Pen Drive.

To prevent overheating, always respect the duty cycles

for each attachment listed on page 42.

For the tool to function properly, Synthes recommends

that it is cleaned and serviced after each use in accordance with the process recommended in the chapter

”Care and Maintenance”. Compliance with these specifications can considerably extend the service life of the

tool. Only use Synthes oil to lubricate the tool.

Efficiently working cutting tools are the basis for successful surgery. Therefore, it is mandatory to check used

cutting tools after every use for wear and/or damage

and to replace them if necessary. We recommend using

new Synthes cutting tools for every surgery.

Cutting tools must be cooled with irrigation liquid to

prevent heat necrosis.

The user of the product is responsible for proper use of

the equipment during surgery.

DO NOT use any component if damage is apparent.

DO NOT use this equipment in presence of oxygen,

­nitrous oxide or a mixture consisting of flammable anesthetic and air. Never use oxygen to run air-powered systems (danger of explosion!); only use compressed air or

compressed nitrogen.

To ensure proper operation of the tool, use only Synthes

original accessories.

Recommended operating pressure: 6–8 bar (see also

chapter System Specification)

Only use original Synthes hoses for compressed air.

Before first and every use, power tools and their accessories/attachments have to run through the complete

­reprocessing procedure. ­Protective covers and foils must

be fully removed before sterilization.

If the Air Pen Drive System is used in conjunction with

an implant system make sure to consult the corresponding ”Surgical Technique”.

This system requires regular maintenance service, at least

once a year, in order to maintain its functionality. This

service has to be performed by the original manufacturer

or an authorized site.

Unusual Transmissible Pathogens

Surgical patients identified as at-risk for Creutzfeldt­Jakob disease (CJD) and related infections should be

treated with single-use instruments. Dispose of instruments used or suspected of use on a patient with CJD

after surgery and/or follow current national recommendations.

Check instruments for correct adjustment and functioning prior to every use.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 6

Introduction

General Information

Precautions:

• Never use oxygen to run air-powered systems

(danger of explosion!); only use compressed air or

compressed nitrogen.

• To avoid injuries, the locking mechanism of the

tool has to be activated before every manipulation

and before placing the tool back down, i.e. the

mode switch has to be in the LOCK positon ( ).

• Should the machine drop on the floor and have

visible defects, do not use it anymore and send it to

the Synthes service center.

• If a product drops on the floor, fragments may split

off. This represents danger for the patient and user

as:

• these fragments may be sharp.

• unsterile fragments may enter the sterile field or

hit the patient.

Accessories/Scope of delivery

The main components in the APD System are the handpiece, Hand Switch, Foot Switch, Air Hose as well as attachments and accessories. An overview of all components belonging to the Air Pen Drive System can be

found in the chapter ”Ordering Information”.

For using the Air Pen Drive System the following components are a must:

• Air Pen Drive 60,000 rpm (05.001.080)

• Hand Switch (05.001.082) or Foot Switch (05.001.081,

also a Double Air Hose from Synthes is necessary to

connect the Foot Switch e.g. 519.510)

• Double Air Hose, for Air Pen Drive (05.001.083 or

05.001.084)

• At least one attachment belonging to the system and

cutting tool fitting to the attachment

For an optimal function of the system only Synthes cutting tools shall be used.

Synthes recommends the use of the specifically designed

Synthes Vario Cases and of the specifically designed

Washing Basket (68.001.800) to sterilize and store the

system.

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DePuy Synthes Air Pen Drive

Instructions for Use

For care and maintenance special tools are available,

such as cleaning brushes, Synthes Maintenance Oil

for EPD and APD (05.001.095), M

­ aintenance Spray

(05.001.098) and Maintenance Unit (05.001.099).

No oils from other manufacturers may be used. Only

Synthes oil may be used.

Lubricants with other compositions can cause jamming,

can have a toxic effect or can have a negative impact on

the sterilization results. Only lubricate the power tool

and the attachments when clean.

Locating of the instrument or fragments of

instruments

Synthes instruments are designed and manufactured to

perform within the scope of their intended use. However, if a Power Tool or accessory/attachment breaks

during use, a visual inspection or a medical imagine device (e.g. CT, Radiation Devices, etc.) can aid in locating

the fragments and/or components of the instrument.

Storage and Transportation

Only use the original packaging for dispatch and transport. If the packing material is no longer available,

please contact the Synthes office. For storage and transport environmental conditions, see page 43.

Warranty/Liability

The warranty for the tools and accessories does not

cover damage of any kind resulting from wear, improper

use, improper reprocessing and maintenance, damaged

seal, use of non Synthes cutting tools and lubricants or

improper storage and transport.

The manufacturer excludes liability for damage resulting

from improper use, neglected or unauthorized maintenance or servicing of the tool.

For further information on the warranty please contact

your local Synthes office.

Page 7

Introduction

Explanation of Symbols

Caution

Read the provided instructions for use before

operating the device.

Do not immerse device in liquids.

0123

The device meets the requirements of directive 93/42/EEC for medical devices. It is authorized by an independent notified body for

which it bears the CE symbol.

Locked symbol. Drive Unit is off for safety.

Date of manufacture and manufacturer

Date of manufacture

non sterile

Non sterile

2

Do not reuse

Products intended for single use must not be

reused.

Reuse or reprocessing (e.g. cleaning and

resterilization) may compromise the §structural integrity of the device and/or lead to device failure, which may result in patient injury,

­illness or death. Furthermore, reuse or reprocessing of single use devices may create a risk

of contamination e.g. due to the transmission

of infectious m

­ aterial from one patient to

­another. This could result in the injury or

death of the patient or user.

Synthes does not recommend reprocessing

contaminated products. Any Synthes product

that has been contaminated by blood, tissue

and/or bodily fluids/matter should never be

used again and should be handled according

to hospital p

­ rotocol. Even though they may

appear undamaged, the products may have

small defects and internal stress patterns that

may cause material fatigue.

Non sterile

Range of temperature

Range of relative humidity

Range of atmospheric pressure

Do not use if package is damaged.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 8

Air Pen Drive System

Air Pen Drive

Mounting the air hose on the handpiece

The Air Hose (05.001.083 or 05.001.084) is coupled by

fitting the pins on the hose coupling into the grooves on

the coupling for hoses on the handpiece and turning the

hose coupling clockwise. Attach the other end of the air

hose to the compressed air or nitrogen source or to the

Foot Switch (05.001.081, see page 10). Ensure that the

coupling geometry of the air hose is compatible with the

geometry of the wall coupling. If the operating room

does not have an exhaust air system then use the Air

Diffusor (519.950) to diffuse the air. The Air Diffusor is

connected between the source and the air hose. To disconnect the air hose simply turn the hose coupling piece

counterclockwise and pull it off the handpiece. Remove

the air hose from the compressed air or nitrogen source

or from the Foot Switch.

Adjusting the handpiece

1 Adjustment sleeve

2 Release sleeve for attachment

3 Coupling for hoses

4 LOCK position

5 Hand Switch position

6 Foot Switch position

7 Lock slide for adjustment sleeve

3

1

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DePuy Synthes Air Pen Drive

Instructions for Use

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Page 9

Adjustment sleeve

To avoid an unintentional change of the operating mode

the lock slide for adjustment sleeve 7 locks the adjustment sleeve automatically. To be able to move the

­adjustment sleeve the lock slide has to be pushed backwards. After having reached the desired position release

the lock slide and the adjustment sleeve is locked in the

­desired position.

4

Lock position

5

Hand switch position

6 7

Foot switch p

­ osition

By turning the adjustment sleeve into the hand switch

position

, the handpiece can be used with the Hand

Switch. In the foot switch position

only the Foot

Switch shall be used! If the foot switch position

is set

and no Foot Switch is attached the handpiece will run

with full speed.

Either a Hand Switch or a Foot Switch can be used for

speed control.

The LOCK position is used for safety switch-off when

changing attachments and tools. This prevents accidental start-up of the unit while performing these activities.

For instructions on mounting the attachments see the

chapter ”Attachments”.

Precaution: The air hoses have to be connected

properly and should never be squeezed with sharp

objects or obstructed by any loads. Non-respect

might lead to bursting of the outer hose!

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 10

Air Pen Drive System

Angular Coupling (05.001.085)

The Angular Coupling (05.001.085) can be connected

to the Air Pen Drive (05.001.080) and the Air Hose

(05.001.083 or 05.001.084) and is used to guide the air

hose away from the handpiece in a 45° angle. It allows

360° ­rotation.

Mounting the Angular Coupling

The Angular Coupling is coupled to the handpiece by fitting the pins into the grooves on the coupling for hoses

on the handpiece and turning the Angular Coupling

clockwise. The Air Hose is then connected to the Angular Coupling by ­fitting the pins on the Air Hose coupling

into the grooves of the Angular Coupling by turning it

clockwise. To disassemble it turn the parts counter-clockwise and pull the Air Hose off the Angular Coupling, and

then the Angular Coupling off the handpiece.

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DePuy Synthes Air Pen Drive

Instructions for Use

Page 11

Air Pen Drive System

Hand Switch (05.001.082)

1

2

3

4

5

Positioning arrow

Pull-out finger rest

Positioning arrow

Guide groove

Locking switch

5

Mounting the Hand Switch on the Handpiece

Position the Hand Switch on the handpiece so that both

­positioning arrows 1 of the Hand Switch cover the positioning arrows 3 over the guide grooves 4 of the pen.

Then press downward vertically until the Hand Switch

clicks into position.

2

1

3 4

Removing

To remove the Hand Switch, grasp the lever and pull it

away ­upwards.

Operation

The adjustment sleeve on the pen must be set on the

hand switch position for working with the Hand Switch.

The length of the Hand Switch can be individually adjusted with the ­pull-out finger rest 2. The speed can be

continuously adjusted by operating the Hand Switch. The

Hand Switch can be ­deactivated (LOCK position) or activated (ON position) with the locking switch 5.

Precaution: Do not set the adjustment sleeve in the

Foot Switch position, if the system is used with the

Hand Switch only and no Foot Switch is connected!

This will make the pen run constantly and can be

very dangerous for patient and OR staff.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Air Pen Drive System

Foot Switch (05.001.081)

1

2

3

4

5

Pedal

Irrigation ON/OFF button*

Plug for Double Air Hose

Plug for Irrigation Control Unit*

Plug for Air Pen Drive Hose

Connecting the Foot Switch

Connect a Double Air Hose (519.510, 519.530, 519.550

for System Synthes; 519.610, 519.630, 519.650 for System

Dräger; 519.511, 519.531 for System BOC/Schrader) to

the male plug for the Double Air Hose on the Foot

Switch 3 and connect it to the air outlet socket.

Then connect the Double Air Hose for Air Pen Drive

(05.001.083 or 05.001.084) to the female plug for Double Air Hoses 5. To remove the air hoses simply slide the

female hose-coupling pieces in ­direction of the arrow.

Operation

The adjustment sleeve on the pen must be set on the

Foot Switch position for working with the Foot Switch.

The speed can be continuously adjusted with the pedal.

Precaution: Never keep the adjustment sleeve in the

Foot Switch position , if no Foot Switch is connected! This will make the pen run constantly and

can be very dangerous for patient and OR staff.

* The Irrigation Control Unit is no longer available

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DePuy Synthes Air Pen Drive

Instructions for Use

1

2

3

4

5

Page 13

Attachments

General Information

Mounting the attachments on the handpiece

The attachments can be connected in 8 different positions (45° increments). To mount, turn the release sleeve

for the attachments clockwise (see arrow on the release

sleeve) until it engages. The release sleeve protrudes

slightly from the black section of the handpiece towards

the front. ­Insert the attachment into the attachment

coupling from the front and press it lightly against the

handpiece. The attachment automatically engages. If the

release sleeve accidentally closes, turn the attachment

clockwise while applying slight pressure against the

handpiece until it engages without holding the release

sleeve in place, or repeat the entire connection process.

Check secure holding of the attachment on the handpiece by pulling on the attachment.

Release sleeve

Removing the attachments from the handpiece

Turn the release sleeve for attachments (see page 6)

clockwise u

­ ntil it disengages. Hold the attachment upward while doing so. Then remove the attachment.

Attachments and accessories

For easier change of burrs, without having the Burr

­Attachment or Cranio­tome Attachment connected to

the handpiece, the Handhold for Change of Instruments

(05.001.074) can be used.

Warranty: Only use Synthes saw blades, burrs and

rasps while working with the Air Pen Drive

­attachments. The use of other tools voids the device

warranty.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 14

Attachments

Drill Attachments

Drill Attachments (05.001.030–05.001.032,

05.001.044)

Speed: approx. 1,800 rpm at 6.5 bar

1

The system includes straight Drill Attachments with Mini

Quick, J-Latch and AO/ASIF Coupling and a 45° cannulated AO/ASIF Drill Attachment.

The 45° Drill Attachment with AO/ASIF Coupling

(05.001.044) has a cannulation of 1.6 mm, which permits the use of this attachment for drilling and reaming

over Kirschner Wire (e.g. for cannulated screws and for

cup and cone technique).

1

1

Mounting and removing tools

Lock unit. Pull back the release sleeve and insert/remove

the tool.

1 Release sleeve

Drill Attachment 45°, cannulated,

with Jacobs Chuck (05.001.120)

Speed: approx. 1,800 rpm at 6.5 bar

Clamping range: 0.5 mm–4.7 mm

The cannulation of 1.6 mm permits the use of this

­attachment for drilling and reaming over Kirschner

Wire (e.g. for cannulated screws and for cup & cone

technique).

Mounting and removing tools

Lock unit. Open the chuck with the key provided

(310.932) or by hand by turning the two moving parts

clockwise with respect to each other. Insert/remove the

tool. Close the chuck by turning the moving parts counterclockwise and tighten it by turning the key clockwise.

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DePuy Synthes Air Pen Drive

Instructions for Use

1

1 Release sleeve

Page 15

1

Drill Attachment 90°, short (05.001.035)

and long (05.001.036) with Mini Quick Coupling

Speed: approx. 1,800 rpm at 6.5 bar

Due to its very small angled head, the 90° Drill Attachments enable good visibility during operations with

­narrow access (e.g. intraoral, shoulder etc.).

Mounting and removing tools

Lock unit. Move the slide 1 to the side following the

­arrow on the slide and insert/remove the tool. To secure

the tool, push the slide back again.

1

1 Slide

Oscillating Drill Attachment (05.001.033)

Frequency: approx. 3,200 osc./min at 6.5 bar

The oscillating drilling movement of the Oscillating Drill

­Attachment prevents tissue and nerves from wrapping

around the drill. This can considerably improve the operating results.

Mounting and removing tools

Cutting tools with a Mini Quick Coupling can be

clamped with the Oscillating Drill Attachment. To do

this, lock the unit, pull back the release sleeve 1 and

­insert/remove the tool.

1

1 Release sleeve

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 16

Attachments

Screw Attachments

Screw Attachments

(05.001.028, 05.001.029, 05.001.034)

Speed: approx. 400 rpm at 6.5 bar

The system includes screw attachments with AO/ASIF

coupling, hexagonal and mini quick coupling.

Mounting and removing tools

Lock unit. Pull back the release sleeve and insert/remove

the tool.

Precautions:

• Only use the attachment with 6.5 bar to avoid

higher speed than 400 rpm.

• Always use the appropriate Torque Limiting device while inserting locking screws into a locking

plate.

• The APD contains no reverse mode for removing

screws.

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DePuy Synthes Air Pen Drive

Instructions for Use

1

1 Release sleeve

Page 17

Attachments

Kirschner Wire Attachment

Kirschner Wire Attachment (05.001.037)

Speed: approx. 2,700 rpm at 6.5 bar

With the Kirschner Wire Attachment, Kirschner Wires of

any length with a diameter of 0.6–1.6 mm can be tensioned. The tensioning lever 1 can be rotated by 300°,

­permitting individual adjustment (suitable for left and

right-handed users).

1

1 Tensioning lever

Mounting and removing Kirschner Wires

Lock unit. To insert and remove Kirschner Wires, press

the tensioning lever 1. After the lever is released, the

Kirschner Wire is automatically tensioned. To re-grasp,

press the ­tensioning lever, pull back the unit along the

Kirschner Wire and then release the tensioning lever

again.

Air Pen Drive

Instructions for Use

DePuy Synthes

11

Page 18

Attachments

Saw Attachments

Working with saw attachments

Allow the unit to start up before placing it on the bone.

Avoid heavy pressure on the saw blade so that the cutting process is not slowed and the saw teeth do not bind

up in the bone. The best sawing performance is

achieved by moving the unit slightly to and fro on the

plane of the saw blade. Imprecise cuts indicate worn

saw blades, excessive pressure or jamming of the saw

blade due to tilting.

Information on handling saw blades

Synthes recommends using a new saw blade for each

surgery, as only then can it be ensured that the saw

blade is ­always optimally sharpened and clean. Used saw

blades present the following risks:

• Necrosis due to excess heat

• Infections due to residues

• Longer cutting time due to reduced sawing

­performance

Sagittal Saw Attachment (05.001.039)

Frequency: approx. 22,000 osc./min at 6.5 bar

Sagittal Saw Attachment, centered (05.001.183)

Frequency: approx. 22,000 osc./min at 6.5 bar

2

1

Sagittal Saw Attachment 90° (05.001.182)

Frequency: approx. 16,000 osc./min at 6.5 bar

Changing saw blades

1. Lock unit.

2. Press the clamping button 1, lift the saw blade

and ­remove it.

3. Push a new saw blade into the saw blade coupling

and move it into the desired position. The saw blade

can be locked in 5 different positions (05.001.039 and

05.001.183) and in 8 different positions (05.001.182)

for optimum positioning (45° increments).

4. Release the clamping button.

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DePuy Synthes Air Pen Drive

Instructions for Use

2

1

1

2

1 Clamping button for saw blades

2 Mounting opening for saw blades

Page 19

Oscillating Saw Attachment (05.001.038)

Frequency: 16,000 osc./min at 6.5 bar

The Oscillating Saw Attachment is used with Synthes

crescentic and 105° angled saw blades.

Changing saw blades

1. Lock unit.

2. Pull back the release sleeve for saw blades 1 and remove the saw blades from the mounting opening 2.

3. Push a new saw blade into the mounting opening

2 and move it into the desired position.

4. Release the release sleeve for saw blades.

Mounting and removing the Guide

for Kirschner Wires (05.001.121)

Secure the Guide for Kirschner Wires on the Oscillating

Saw, by pushing the Guide as far as possible over the attachment from the front, so that it engages in the shape

of the Oscillating Saw.

2

1

1 Release sleeve for saw blades

2 Mounting opening for saw blades

Kirschner Wire B 1.6 mm

Then mount the attachment on the handpiece.

Note: No irrigation nozzle is available for the oscillating saw attachment.

Reciprocating Saw Attachment (05.001.040)

Frequency: 18,000 osc./min at 6.5 bar

Stroke: 2.5 mm

Both Synthes reciprocating saw blades and Synthes rasps

can be used with the Reciprocating Saw Attachment.

1

1 Release sleeve for saw blades

Replacing saw blades

1. Lock unit.

2. Turn the release sleeve for saw blades 1 clockwise

­until it ­engages and remove the saw blade.

3. Insert a new saw blade until slight resistance can be

felt. Turn the saw blade with slight pressure until it

automatically engages.

Air Pen Drive

Instructions for Use

DePuy Synthes

11

Page 20

Attachments

Burr Attachments

Burr Attachments

(05.001.045–05.001.050, 05.001.055, 05.001.063)

Gear ratio: 1:1

The system includes straight and angled Burr Attachments in 3 lengths each (S, M, L). The related burrs are

also marked with S, M and L. Angled XL and XXL Burr

Attachments are available; for these attachments the L

burrs shall be used.

Changing burrs

1. Lock unit.

2. Turn the release sleeve for burrs 1 until it engages in

the ­UNLOCK position and remove the tool.

3. Insert the new tool as far as possible, turn it slightly

until it locks in place and then turn the release sleeve

for burrs into the LOCK position until it engages. The

burr is correctly clamped when the marking S, M or L

on the burr shank is no longer visible.

Information on handling burrs

• Synthes recommends using a new sterile burr for each

operation. This prevents health risks to the patient.

• Used burrs present the following risks:

• Necrosis due to excess heat

• Longer cutting time due to reduced performance

of the burr

Precautions:

• Burrs must be cooled with irrigation liquid to

­prevent heat necrosis.

• The size of the burr attachment must correspond

to the size of the burr (e.g. attachment size S with

burr size S) or one burr size bigger (e.g. attachment

size S with burr size M).

• User and OR personal must wear safety goggles

when working with burrs.

• When the Burr Attachments are not attached to

the handpiece during tool change, use the Handhold (05.001.074) for easier change of burrs.

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DePuy Synthes Air Pen Drive

Instructions for Use

1

1

1 Release sleeve for burrs

Page 21

Drill/Burr Attachment, Straight,

for Round Shafts B 2.35 mm (05.001.123)

Gear ratio 1:1

1

Friction fit attachment for 2.35 mm diameter shafts with

round shaft, J-latch and Mini-quick coupling.

Changing cutting tools

1. Lock unit.

2. Turn the release sleeve (1) until it engages in the UNLOCK position and remove the tool.

3. Insert the new tool and turn the release sleeve into

the LOCK position until it engages.

Precautions:

• The user is liable for the safety and correct application of the Synthes Power Tool including the attachment and the cutting tool including the following items in particular:

• maximum speed of the Drill/Burr Attachment for

Round Shafts with 2.35 mm diameter (05.001.123)

is 60,000 rpm

• the use of appropriate cutting tools (specifically

length and speed)

• the secure fixation of the cutting tool, i.e. the tool

must be chucked at least 20 mm deep

• the instrument must be rotating before contact is

made with the workpiece

• avoid jamming and using the instrument as a lever as this leads to an increased risk of breakage

• Check the vibration and the stability of the used

cutting tool before every usage on the patient. If vibration or instability occur, reduce the speed until

there is no vibration anymore or do not use the

burr.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 22

Attachments

Adapter for Intra Coupling

Adapter for Intra Coupling (05.001.103)

Gear ratio 1:1

The Adapter for Intra Coupling (05.001.103) enables the

use of dental handpieces, mucotomes and dermatomes

designed according to ISO 3964 (EN 23 964) in combination with the Electric Pen Drive (05.001.010) and Air Pen

Drive (05.001.080).

Warranty/Liability: The user is responsible to ensure the compatibility of products used in combination with the Electric- and Air Pen Drive System

and the Adapter for Intra Coupling.

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DePuy Synthes Air Pen Drive

Instructions for Use

Page 23

Attachments

Perforators

Perforator (05.001.054)

Gear reduction: 97:1

The perforator is used with the related trepan burrs

(03.000.350–03.000.351) including the protective

sleeves (05.001.096–03.001.097) to open a cranium

with a thickness of 3 mm or above. The handpiece has to

be in the FWD

position. Hold the perforator perpendicular to the skull at point of penetration and always

apply constant pressure when the trepan burr is engaged in the bone. As soon as the cranium is cut

through, the trepan burr automatically disengages.

Perforator

05.001.054

Trepan Burr

03.000.350–03.000.351

Protection Sleeve

05.001.096–05.001.097

Changing trepan burrs

1. Turn the release sleeve for trepan burrs (1) until

the locking pin (2) disengages from the locking

groove (3). (Position , Fig. 1).

2. Pull off the trepan burr together with the protective

sleeve.

3. Insert a new trepan burr into the protective sleeve and

make sure that the pins on the trepan burr engage

properly in the grooves in the protective sleeve.

4. Place the new trepan burr together with the protective sleeve on the perforator.

5. Turn the release sleeve for trepan burrs (1) until the

locking pin (2) engages in the locking groove (3).

(Position , Fig. 2).

Precautions:

• If conditions such as adherent dura, intracranial

pressure or other underlying abnormalities are

present in the area of the penetration, the perforator may cut the dura. Caution must be observed

when perforating thin skull areas such as temporal bone, infants, children, elderly, or diseased

bone since skull consistencies and thicknesses can

vary and the dura could be cut. Only use the perforator 05.001.054, the trepan burrs 03.000.350–

03.000.351 and the protective sleeves 05.001.096–

05.001.097 on bones with a thickness of 3 mm or

above.

3

2

1

1 Release sleeve for trepan burrs

2 Locking pin

3 Locking groove

Fig. 1

Fig. 2

• It is recommended to cool the trepan burr during

trepanation (use the irrigation nozzle 05.001.076).

• Check function before each use of the perforator.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 24

Attachments

Perforators

Perforator with Hudson Coupling (05.001.177)

Gear reduction: 97:1

The Perforator with Hudson coupling is used with a trepan burr / protection sleeve combination – usually referred to as a cranial perforator – with a Hudson end to

open the cranium. The operational mode of the hand

piece has to be FWD

. Hold the perforator perpendicular to the skull at the point of penetration and always

apply constant pressure when the trepan burr is engaged in the bone.

Changing the cranial perforator

1. Attaching the cranial perforator:

First move the coupling sleeve (1) on the adapter toward

the rear, and then completely insert the tool.

After the tool has been fully inserted, release the

­coupling sleeve. Check that the tool is properly locked in

the attachment by gently pulling on it.

2. Removing the cranial perforator:

First move the coupling sleeve (1) towards the rear, and

then remove the tool.

Precautions:

• For the use of the trepan burrs or cranial perforators the respective instructions for use with warnings and restrictions of the supplier is valid.

• It is recommended cooling the cutting tool during

trepanation to avoid heat necrosis. Use the irrigation nozzle 05.001.180. Make sure that the irrigation nozzle is placed in a way that the cooling

­liquid reaches the tool.

• Check function before each use of the perforator.

• The user is liable for the surgical application.

• The user is liable to check the compatibility of the

Perforator with Hudson Coupling, the Irrigation

Nozzle and the cutting tool used.

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DePuy Synthes Air Pen Drive

Instructions for Use

1

1 Coupling sleeve

Page 25

Attachments

Craniotome Attachment

Craniotome Attachment (05.001.059)

and Dura Guards (05.001.051–05.001.053)

Gear ratio: 1:1

The system includes a Craniotome Attachment and Dura

Guards in 3 lengths (S, M, L). The related burrs are also

marked with S, M and L.

Craniotome Attachment

05.001.059

Cranial Burr

03.000.124S–03.000.126S

Dura Guard

05.001.051–05.001.053

Changing cranial burrs

1. Lock the handpiece.

2. Turn the release sleeve for burrs (1) until it engages

in the UNLOCK position.

3. Pull off the Dura Guard over the burr and remove

the burr.

4. Insert the new burr as far as possible turning it

slightly. The burr is correctly inserted when the Dura

Guard can be properly fitted.

5. Push the Dura Guard over the burr and mount the

Dura Guard on the Craniotome Attachment (pay

­attention to the arrows for the correct inserting position (2)). Then turn the release sleeve of the Craniotome Attachment into the LOCK position until it

engages to clamp the burr and the Dura Guard.

6. Check that the Cranial Burr can be turned freely

and that the Dura Guard is well engaged by pulling

on it slightly.

1

1 Release sleeve for burrs and Dura Guard

2 Arrows indicating the proper inserting position

Precautions:

• Only use the Craniotomes with the related Cranial

Burrs.

• Cranial Burrs must be cooled with irrigation liquid to avoid heat necrosis to the nozzle built into

the Dura Guard.

• Avoid side load on the burr and Dura Guard in

­order to prevent breakage of the Dura Guard.

• When the Craniotome Attachment is not attached

to the handpiece during tool change, use the Handhold (05.001.074) for easier change of the burr and

Dura Guard.

Air Pen Drive

Instructions for Use

DePuy Synthes

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Page 26

Cutting Tools

General Information

Intended use

Saw blades

The saw blades are designed for use in traumatology

and orthopaedic surgery of the skeleton, e.g. cutting

bone.

Stainless steel burrs

Stainless Steel Burrs (Small Torx Cutting Tools) are

designed for the use in surgery of the skeleton, i.e.

cutting, shaping, smoothing, drilling, reaming or

burring of bones.

Diamond coated or carbide burrs

Diamond coated or carbide burrs (Small Torx Cutting

Tools) are designed for the use in surgery of the skeleton, i.e. cutting, shaping, smoothing of bones, teeth

and metal.

Single Use/Reprocessing

For best results Synthes recommends using a new cutting tool for each operation. Performing cuts with a new

and sharp cutting tool is faster, more precise and generates less heat development. This results in a shorter surgery time, a reduction of risk of bone necrosis and a better, reproducible result.

All diamond coated or carbide cutting tools are single

use only.

Packaging and Sterility

All cutting tools are available sterile packed.

The manufacturer cannot guarantee sterility if the package seal is broken or if the package is improperly

opened, and ­assumes no liability in such instances.

Dimension

Cutting tool dimension is enclosed within the packaging

­label.

Cooling of Cutting Tools

Synthes strongly recommends the use of cooling fluid to

cool cutting tools.

Implant Removal with Cutting Tools

Implant removal with cutting tools should only be

­conducted if no other solution for implant removal exists. Only use diamond coated or carbide cutting tools.

Remove all particles by continuous flushing and vacuuming. Soft tissue must be covered well. Observe the

­material composition of the implant.

User Safety

User and OR personal must wear safety goggles.

Disposal of the Cutting Tools

Only dispose contaminated cutting Tools within contaminated hospital waste or decontaminate it.

For further information regarding cutting tools refer to

the Instructions for Use ”Synthes Cutting Tools”

(60121204).

For cleaning and sterilization of cutting tools refer to

”Clinical Processing of Cutting Tools” (036.000.499) for

detailed clinical processing instructions.

For an overview and the ordering information of all cutting tools available refer to the brochure ”Small Bone

Cutting Tools” (DSEM/PWT/1014/0044).

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DePuy Synthes Air Pen Drive

Instructions for Use