Compact Air Drive II Instructions for Use

Contents

Introduction

Using the Compact Air Drive II

General Information

2

Explanation of symbols used

4

Handpiece5 Startup of the Compact Air Drive II system

6

Attachments7

Care and Maintenance

General Information

23

Preparation Prior to Cleaning

24

Cleaning and Disinfection • Manual Cleaning Instruction • Automated Cleaning Instruction with Manual Pre-cleaning

25 25

Maintenance and Lubrication

30

Inspection and Function Test

32

Packaging, Sterilization and Storage 

33

Repairs and Technical Service

35

Disposal of Waste

36

27

Troubleshooting

37

System Specifications

39

Ordering Information 

43

Compact Air Drive II

Instructions for Use

DePuy Synthes

1

Introduction

General Information Intended use The Compact Air Drive II is an air-driven power tool for use in traumatology, endoprosthetics and spinal column surgery.

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 Compact Air Drive II 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 Compact Air Drive II System is designed for use by physicians and trained medical personnel. DO NOT use any apparently damaged components. DO NOT use any component if the packaging is damaged. To ensure correct operation of the tool, use only Synthes original accessories. Recommended operating pressure: 6– 7 bar (max 10 bar). Only use original Synthes hoses for compressed air. Before the first and every use and prior returning for service, power tools and their accessories/attachments have to run through the complete reprocessing procedure. ­Protective covers and foils must be fully removed before sterilization. The user of the product is responsible for proper use of the equipment during surgery.

Check correct operation of the tools before using it on the patient.

2

DePuy Synthes Compact Air Drive II Instructions for Use

For the tool to function properly, Synthes recommends that it is cleaned and serviced after each use in accordance with the process defined in the “Care and Maintenance” section. Compliance with these specifications can considerably ex­tend the service life of the tool and reduce the risk of mal­function or harm to the user and patient. Only use Synthes Special Oil (519.970) to lubricate the tool. We recommend using new Synthes cutting tools for every surgical procedure. Efficiently working cutting tools are the basis for successful surgery. Therefore, check used cutting tools after every use for wear and/or damage and replace them if necessary. Cutting tools must ­ be cooled with irrigation fluid to prevent heat necrosis. 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. Servicing 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. The manufacturer assumes no responsibility for damage re­sulting from improper operation, neglected or unauthorized maintenance of the tool.

Precautions: • Always wear personal protective equipment (PPE) including safety goggles when handling the Compact Air Drive II system. • DO NOT use this equipment in presence of oxygen, ni­t rous oxide or a mixture consisting of flammable anesthetic and air (danger of explosion). Only use compressed air or nitrogen for this equipment. • 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 softmode switch has to be turned in the “OFF“ position. • Should the machine drop on the floor and have visible d ­ efects, 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 a danger for the patient and user as: • These fragments may be sharp. • Unsterile fragments may enter the sterile field or hit the patient. • Should the system have corroded parts, do not use it anymore and send it to the Synthes service center. Accessories /Scope of delivery The main components in the Compact Air Drive II System are the handpiece, the air hose and attachments and accessories. An overview of all components belonging to the Compact Air Drive System can be found in the chapter “Ordering Information”.

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 transport Only use the original packaging for dispatch and transport as otherwise damage may occur. If the packing material is no longer available, please contact your local Synthes office. For storage and transport environmental conditions please refer to the section “System specification”. 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.

The following components are essential to ensure proper ­operation: • 1 Compact Air Drive II Handpiece (511.701) • 1 Air Hose (see chapter “Ordering Information”) • 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 care and maintenance special tools are available, such as cleaning brush (519.400) and Synthes Synthes Special Oil (519.970). Only Synthes oil may be used. Lubricants of 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 after the cleaning procedure.

Compact Air Drive II

Instructions for Use

DePuy Synthes

3

Introduction

Explanation of symbols used The following symbols are applied to the device or individual components. Information on additional symbols is given in the relevant sections of this document.

Caution Read the provided Instructions for Use before operating the device. 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. 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

4

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.

DePuy Synthes Compact Air Drive II Instructions for Use

Locked symbol. Drive Unit is off for safety.

Manufacturer

Date of manufacture

non sterile Non sterile

Relative humidity

Atmospheric pressure

Do not use if package is damaged.

Using the Compact Air Drive II

Handpiece Operation 1 Attachment coupling 2 Unlocking button for attachment coupling 3 Speed regulation 4 Reverse running selection 5 Softmode switch with safety function 6 Hose coupling

2

1

4 3

Forward/reverse running Use the bottom trigger 3 to gradually adjust the forward speed up to 900 rpm. Simultaneously pull the top trigger 4 to immediately switch to reverse mode. Safety system The Compact Air Drive II has a safety system that prevents the drive from being accidentally started.

5

To lock the unit, turn the softmode switch 5 fully clockwise to the “OFF“ position. To unlock it, turn the softmode switch 5 counterclockwise to the desired power level.

6

Adjusting the maximum power The maximum power can be adjusted gradually by turning the softmode switch 5 to the appropriate marking on the handpiece. Precaution: The unit must be locked with the softmode switch when mounting and removing attachments and tools and before you stop working with it.

4

3

5

Compact Air Drive II

Instructions for Use

DePuy Synthes

5

Using the Compact Air Drive II

Startup of the Compact Air Drive II system Connecting the compressed air hose to the handpiece Shove the female hose coupling onto the male hose coupling until it locks into place. The coupling will lock by itself with an audible click. Attach the other end of the air hose to the compressed air or nitrogen source. 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. Removing the compressed air hose Disconnect the hose by pulling back the hose coupling sleeve. Remove the air hose from the compressed air or nitrogen source.

Precautions: • The air hose has to be connected properly and should never be squeezed or obstructed by any loads. Non-respect might lead to bursting of the outer hose! • Always check correct functioning before use on patient. • Always have a back-up system to prevent problems in case of deficient system. • Always wear personal protective equipment (PPE) including safety goggles when working with the Compact air Drive II system.

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DePuy Synthes Compact Air Drive II Instructions for Use

Attachments Please observe the safety instructions and warnings on the relevant pages when working with attachments. Mounting the attachments Insert the desired attachment into the attachment ­coupling of the handpiece until it engages. Do not press the release button for the attachment coupling when mounting the ­attachments. Ensure that the attachment is correctly held in the ­attachment coupling by pulling on it slightly. Removing the attachments Pressing the unlocking button releases the attachment from the attachment coupling and shifts it slightly forward. Then remove the attachment.

Precautions: • To prevent injury, the tool must be locked with the safety system (see page 5) during each manipulation. • Make sure not to press the triggers (especially the top ­t rigger) when mounting and removing the attachments. • When mounting and removing attachments, do not s­ imultaneously pull on the attachment while pressing the ­unlocking button. This can make it difficult to remove the ­attachment. • Only use original attachments and tools from ­Synthes. Damage that might arise from using attachments and tools of other manufacturers is not covered by the warranty. • During reaming procedure, high torque values must be ­provided by the power tool to the reaming head to allow ­efficient bone removal. In cases where the reaming head suddenly is blocked, these high torque values can be transferred onto the user’s hand, wrist and/or the patient’s body. In order to prevent injuries it therefore is essential that: • The power tool is held in an ergonomical position with a firm grip. • If the reamer head blocks, the speed trigger is ­released immediately. • The correct function of the speed trigger (immediate stop of the system when the trigger is released) is checked ­before the reaming process. Compact Air Drive II

Instructions for Use

DePuy Synthes

7

Using the Compact Air Drive II

AO/ASIF Quick Coupling (511.750) Attaching cutting tools: Slide forward the ring on the attachment, and fully insert the tool while rotating it slightly. After the tool has been fully inserted, release the ring. ­ Pull on the tool to make sure that it is correctly locked in the coupling. Removing cutting tools: First slide the ring on the attachment forward, and then ­remove the tool.

Quick Coupling for DHS/DCS Triple Reamers (511.761) Attaching cutting tools: First slide the coupling sleeve on the attachment to the rear in the direction of the arrow, and then insert the tool. After the tool has been fully inserted, release the coupling sleeve. Pull on the tool to make sure that it is correctly locked in the coupling. Removing cutting tools: First slide the coupling sleeve on the attachment to the rear in the direction of the arrow, and then remove the tool.

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DePuy Synthes Compact Air Drive II Instructions for Use

Drill Chuck with key (511.730) Attaching cutting tools: Open the jaws of the chuck with the provided key (510.191) or by hand by turning the two moveable parts against each other to the right (clockwise). Insert the shaft of the tool into the open chuck. Close the Drill Chuck by rotating the moveable parts against each other to the left. Make sure that the shaft remains in the middle between the three jaws of the chuck. To tighten the chuck, turn the key (510.191) to the right (clockwise). The teeth of the key must be correctly seated in the toothed rim of the chuck. Removing cutting tools: Open the chuck by turning the key (510.191) to the left, and remove the tool.

Drill Chuck, keyless (511.731) Attaching cutting tools: Open the jaws by rotating the ring counter-clockwise. Insert the tool shaft into the open chuck, and close the jaws. Make sure that the shaft remains in the middle between the clamps of the chuck. Removing cutting tools: Open the chuck jaws by turning the ring counter-clockwise, and remove the tool.

Compact Air Drive II

Instructions for Use

DePuy Synthes

9

Using the Compact Air Drive II

Quick Coupling for Kirschner Wires (511.791) Inserting the Kirschner Wire: Completely open the adjusting sleeve at the end of the attachment, insert the Kirschner Wire, and close the adjusting sleeve until it clamps the wire. Then open the adjusting sleeve three clicks. The Kirschner Wire is automatically lightly held in the selected position. If the wire is clamped, open the adjusting sleeve until it is released. Clamping the Kirschner Wire and inserting it in the bone: To clamp the Kirschner Wire, pull the tension lever against the handle of the unit. The Kirschner Wire remains clamped as long as the lever is held. Simultaneously press the forward trigger to drill the wire into the bone. Hold the tension lever until the Kirschner Wire is inserted. To grasp the wire at a different place, release the lever, move the tool with the attachment along the Kirschner Wire to the desired length, and pull the lever against the handle. Removing the Kirschner Wire from the bone: To remove the Kirschner Wire from the bone, grip it with the tension lever and pull it out of the bone while pressing both triggers for reverse.

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DePuy Synthes Compact Air Drive II Instructions for Use

Attachment for Acetabular and Medullary Reaming, with reverse option (511.786) Mounting the attachment: To enable reverse running, the attachment must be coupled onto the drive unit in such a way that the marked arrow on the attachment lies on the top. Attaching cutting tools: Insert the tool into the opening of the Attachment for Acetabular and Medullary Reaming, and press both parts together until they lock. Removing cutting tools: First pull back the movable ring on the attachment, and then remove the tool.

Compact Air Drive II

Instructions for Use

DePuy Synthes

11

Using the Compact Air Drive II

Radiolucent Drive (511.300) The Radiolucent Drive can be used with the Compact Air Drive II in combination with the AO/ASIF Quick Coupling (511.750). Maximum speed: approx 1100 rpm Maximum torque: approx. 1.3 Nm Technical data is subject to tolerances. Assemble Radiolucent Drive: Mount the quick AO/ASIF Quick Coupling (511.750) on the CADII handpiece. Slide the Radiolucent Drive over the quick coupling and twist until the drive shaft engages. Rotate the Radiolucent Drive into the desired working position. Support the drive with your free hand. Disassemble Radiolucent Drive: Pull the Radiolucent Drive off the AO/ASIF Quick ­Coupling. Press the unlocking button and remove the attachment.

Note: • Grip the coupled Radiolucent Drive tightly when switching on the power tool, particularly if the power tool is held face down. • Only special 3-flute spiral drill bits can be used. Your Synthes representative will provide you with additional information on which drill bits can be used. • Handle the Radiolucent Drive with great care. Do not al­low contact between the drill bit and the medullary nail. • Depending on the setting of the image intensifier, a zone may appear in the rear of the Radiolucent Drive that is not radiolucent. However, this does not inhibit aiming and working with the device. • To protect the gears, the Radiolucent Drive is equipped with a slip clutch that disengages in case of an overload and emits an audible rattling.

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DePuy Synthes Compact Air Drive II Instructions for Use

• The following procedures can cause an overload: • Correcting the drilling angle when the cutting edges of the drill bit are completely in the bone. • Hitting the nail with the drill bit. • Drilling can continue after making the following corrections: Correcting the drilling angle: • Remove the drill bit until the flutes are visible, and restart drilling. • Hitting a nail: Remove the drill bit until the flutes are visible, and re-aim the drill bit or exchange the drill bit if necessary. • Check the drill bits for wear and/or damage after each use, and replace if necessary. Synthes recommends that cutting tools are only used once for patient safety.

Insert drill bits 1. Pull the ring on the Radiolucent Drive forward and push the drill bit into the coupling as far as it can go while rotating it slightly (Fig. 1). 2. Engage the ring on the attachment back to fix the drill bit. Check if the drill bit is seated correctly by gently pulling on it. Remove drill bits To remove the drill bit execute step 1 and 2 above in ­reverse order. Figure 1

Using the Radiolucent Drive Before positioning the Radiolucent Drive, align the image intensifier until the distal locking hole of the medullary nail is round and easily visible (Fig. 2). After the incision, position the Radiolucent Drive and center the drill bit tip over the locking hole. On the monitor of the image intensifier, you can see both the drill bit and the target rings of the drive. Swing the drive up and center it precisely so that the drill bit appears as a round point and the locking hole is ­visible around it. The target rings also assist centering. The locking hole can now be drilled directly (Figs. 3 and 4).

Figure 2

For further information on the Radiolucent Drive and on the special 3-flute spiral drill bits please consult the relevant Instructions for Use (036.000.150) or your local Synthes office.

Figure 3

Figure 4

Compact Air Drive II Instructions for Use

DePuy Synthes

11

Using the Compact Air Drive II

Oscillating Drill Attachment (511.200) The Oscillating Drill Attachment (511.200) can be used on the Compact Air Drive II together with the AO/ASIF Quick Coupling (511.750).

Mounting the attachment: Slide the Oscillating Drill Attachment from the front over the quick coupling (511.750) up to the stop (Fig. 1). ­Rotate the handpiece and Oscillating Drill Attachment in relation to each other until the attachment locks onto the top trigger (Fig. 2). This simultaneously keeps you from unintentionally activating reverse. Removal: Follow the same procedure in reverse. Inserting the drill bit: First shove the sleeve on the front part of the Oscillating Drill Attachment forward, and then completely insert the drill bit under slight rotation.

Fig. 1

Let the sleeve slide back, and check that the drill bit is ­properly locked by pulling on it. Removal: Follow the same procedure in reverse. Recommendation: It is best to use a three-flute drill bit in the Oscillating Drill Attachment. It is easier to drill into an angled surface with such bits.

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DePuy Synthes Compact Air Drive II Instructions for Use

Fig. 2

Oscillating Saw Attachment (511.800) Mounting the attachment: Shove the attachment onto the tool. There is a noticeable r­ esistance. The attachment then clicks into place to show that the coupling was successful. Once the attachment is mounted, reverse is automatically blocked. The attachment can be locked in eight different positions. When the attachment needs to be rotated after it is coupled, it must first be uncoupled, and the attachment is pulled a­ pprox. 1 cm forward. Adjust the desired angle (45° increments), and shove the attachment back toward the tool until it locks into place. Removal: Follow the same procedure in reverse. Precautions: • Do not simultaneously pull the saw attachment forward while pressing the release button. • When removing the saw attachment, keep the vent hole free on the bottom of the coupling shaft. • When mounting and removing the attachment, do not press the top trigger. This can damage the power tool. • After inserting a cutting tool, always check that it is properly engaged by pulling it. Changing saw blades: 1. Loosen the screw by about four turns with the key (518.090). 2. Remove the saw blade by first pressing the saw blade against the screw head, and then pull it out in a forward direction. 3. Insert the new saw blade by exerting a slight pressure against the screw head and then adjusting it to the position required. The saw blades can be locked in different positions. 4. Retighten the screw with the key (518.090).

Compact Air Drive II

Instructions for Use

DePuy Synthes

11

Using the Compact Air Drive II

Adjusting the amplitude: The deflection of the saw blade can be changed with the ­Oscillating Saw Attachment (511.800). This is frequently necessary when doing precision work and when very long saw blades are used. Vibration can be minimized, and the sawing performance can be optimized. It does not matter if the ­deflection is set before you start or while you are working. To adjust the deflection, turn the adjuster lever to the desired deflection. “Min” corresponds to a deflection of 2.5°, “Max” to 5°, and the neutral position equals 4° of deflection. Maximum sawing power is obtained in the center ­position.

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DePuy Synthes Compact Air Drive II Instructions for Use

Oscillating Saw Attachment II (511.801) Mount and remove the attachment in the same manner as Oscillating Saw Attachment 511.800. Changing saw blades: 1. Open the saw blade quick coupling by rotating the ­fixation knob counter-clockwise. 2. Remove the saw blade by first pressing the saw blade against the screw head, and then pull it out in a forward direction. 3. Insert the new saw blade by exerting a slight pressure against the screw head and then adjusting it to the position required. The saw blades can be locked in different positions. 4. Lock the saw blade coupling by tightening the fixation knob clockwise. Make sure that the fixation knob is firmly tightened. Otherwise the screw can loosen during use causing the saw blade to vibrate.

Compact Air Drive II

Instructions for Use

DePuy Synthes

11

Using the Compact Air Drive II

Reciprocating Saw Attachment (511.902) Mounting the attachment: The attachment can be locked in eight different positions (offset in 45° steps). Shove the Reciprocating Saw Attachment onto the tool in the desired position. There is a noticeable ­resistance. The attachment then clicks into place and shows that the coupling was successful. Reverse is now blocked. To change the position, first release the coupling mechanism with the release button, then use your other hand to shove the attachment approx. 1 cm forward, rotate it into the ­desired position, and shove it back until it locks on the tool. Removal: Release the coupling mechanism with the release button, and then use your other hand to remove the attachment from the machine. Precautions: • Do not simultaneously pull the saw attachment forward while pressing the release button. • When removing the saw attachment, keep the vent hole free on the bottom of the coupling shaft. • When coupling and releasing the attachment, do not press the top trigger. This can damage the power tool. Changing saw blades: Turn the lock knob in the direction of the arrow until the saw blade jumps forward approx. 1 mm. Remove the saw blade from the coupling (the slot of the lock knob and saw blade coupling are in the same axis). Insert the new saw blade in the guide slot of the saw blade coupling until the lock knob springs back into locked position with a click (the slot of the lock knob and saw blade coupling are axially offset). Check if the saw blade is seated tightly by pulling in a lengthwise direction.

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DePuy Synthes Compact Air Drive II Instructions for Use

Top for Sternum for Reciprocating Saw Attachment (511.904) Mounting the attachment: Use the Top for Sternum together with the Reci­procating Saw Attachment (511.902). The Top for Sternum can be placed on the Reciprocating Saw Attachment and tightened with the provided Allen wrench. Make sure that it is seated well. Removal: Follow the same procedure in reverse. Changing saw blades: Follow the same procedure as for Reciprocating Saw Attachment (511.902). Note that only Reciprocating Saw Blade (511.915) may be used since its length is adapted to the length of the Top for Sternum. Precaution: Only use the Saw Blade 511.915 for the Top for Sternum Attachment. The length of this saw blade is adapted to the Top for Sternum Attachment. Working with saw attachments The tool must be operating when the attachment makes contact with the bone. Do not exert excessive pressure on the saw since it slows down sawing because the saw teeth catch in the bone. The best sawing performance is achieved by moving the tool slightly back and forth in the plane of the saw blade so that the blade can go a bit beyond the bone on both sides. Very precise cuts can be made when the saw blade is guided steadily. Imprecise cuts arise due to used blades, excess pressure, or jamming the saw blade. Instructions for handling saw blades Synthes recommends using a new blade for each operation to ensure that the saw blade is optimally sharp and clean. The following risks are associated with used blades: • Necrosis caused by excessive heat build-up • Infection caused by residue • Extended cutting time from poor sawing performance Precaution: Saw blades labeled “Single Use” should not be used repeatedly because of cleaning problems. Compact Air Drive II

Instructions for Use

DePuy Synthes

11