DePuy Synthes Air Pen Drive 05.001.082 Instructions for Use March 2018

Table of Contents

Introduction

Air Pen Drive System

Attachments

Cutting Tools

General Information

3

Explanation of Symbols

5

Air Pen Drive

6

Angular Coupling (05.001.085)

8

Hand Switch (05.001.082)

9

Foot Switch (05.001.081)

10

General Information

11

Drill Attachments

12

Screw Attachments

14

Kirschner Wire Attachment

15

Saw Attachments

16

Burr Attachments

18

Adapter for Intra Coupling

20

Perforators

21

Craniotome Attachment

23

General Information

24

Air Pen Drive

Instructions for Use

DePuy Synthes

1

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

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 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

3

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.

4

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.

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

5

Air Pen Drive System

Air Pen Drive

Mounting the air hose on the handpiece The Air Hose (05.001.083 or 05.001.084) is coupled by fitting the pins on the hose coupling into the grooves on the coupling for hoses on the handpiece and turning the hose coupling clockwise. Attach the other end of the air hose to the compressed air or nitrogen source or to the Foot Switch (05.001.081, see page 10). Ensure that the coupling geometry of the air hose is compatible with the geometry of the wall coupling. If the operating room does not have an exhaust air system then use the Air Diffusor (519.950) to diffuse the air. The Air Diffusor is connected between the source and the air hose. To disconnect the air hose simply turn the hose coupling piece counterclockwise and pull it off the handpiece. Remove the air hose from the compressed air or nitrogen source or from the Foot Switch.

Adjusting the handpiece 1 Adjustment sleeve 2 Release sleeve for attachment 3 Coupling for hoses 4 LOCK position 5 Hand Switch position 6 Foot Switch position 7 Lock slide for adjustment sleeve

3

1

6

DePuy Synthes Air Pen Drive

Instructions for Use

2

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

6 7

Hand switch position

Foot switch p ­ osition

Instructions for Use

DePuy Synthes

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

7

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.

8

DePuy Synthes Air Pen Drive

Instructions for Use

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

9

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

11

DePuy Synthes Air Pen Drive

Instructions for Use

1

2

3 4 5

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

11

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.

11

DePuy Synthes Air Pen Drive

Instructions for Use

1 1 Release sleeve

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

11

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.

11

DePuy Synthes Air Pen Drive

Instructions for Use

1 1 Release sleeve

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

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.

11

DePuy Synthes Air Pen Drive

Instructions for Use

2 1 1 2 1 Clamping button for saw blades 2 Mounting opening for saw blades

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

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.

11

DePuy Synthes Air Pen Drive

Instructions for Use

1

1 1 Release sleeve for burrs

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

11