Electric Pen Drive Instructions for Use

Table of Contents

Introduction

Consoles

Electric Pen Drive System

Attachments

General Information

3

Explanation of Symbols

7

Standard Consoles

8

Basic Console

8

Set-up of Consoles

9

Speed Regulation

11

Irrigation

12

System Electric Pen Drive 60,000 rpm (05.001.010)

14

Hand Switch (05.001.012)

15

Foot Switch, 1 Pedal (05.001.016)

16

General Information

17

Drill Attachments

18

Screw Attachments

20

Kirschner Wire Attachment

21

Saw Attachments

22

Burr Attachments

24

Adapter for Intra Coupling

26

Perforators

27

Craniotome Attachment

29

■ Notes ▲ Precautions ▲ WARNINGS

Electric Pen Drive • Instructions for Use

1

Table of Contents

Care and Maintenance

General Information

30

Cleaning and Disinfection

32

Preparation Prior to Reprocessing

32

Manual Cleaning Instructions

33

Automated Cleaning Instructions with Manual Pre-cleaning 

35

Maintenance and Lubrication

39

Function Control

42

Packaging, Sterilization and Storage

43

Repairs and Technical Service

44

Disposal

45

Troubleshooting

46

System Specifications

48

Electromagnetic Compatibility

54

Electrical Safety Check of the Consoles

58

Ordering Information

61

2

Instructions for Use • Electric Pen Drive

Introduction

General Information

Introduction

Contraindications

The Electric Pen Drive (EPD) consists of a handpiece, a hand or foot switch, consoles, a range of attachments and accessories designed for the system. Important note for medical professionals and OR staff: These instructions for use do not include all of the infor­ mation necessary for selection and use of the device. ­ In addition, please read the instructions for use carefully before using the system: • Instructions for Use Synthes Cutting Tools • Small Bone Cutting Tools Brochure • Electric Pen Drive/Air Pen Drive Care and Maintenance Poster • Washing Basket Electric Pen Drive Loading Plan 1/1 • Lubricants and Lubrication Adapters for Power Tools • Synthes bro­chure titled “Important Information”

The Electric Pen Drive system does not have any product specific contraindications. Synthes manufactures surgical instruments are intended to prepare the site and aid in ­implantation of Synthes implants. The contraindications are based upon the implant devices rather than the instruments. ­Specific contraindications for the implants can be found in the respective Synthes implant instructions for use.

When working with implants, ensure you are familiar with the appropriate technique by referring to the ­Synthes implant instructions for use. The manufacturer is not ­responsible for any complications arising from incorrect diagnosis, choice of incorrect implant, incor­rectly combined implant components and/or operating.

Intended Use The Electric Pen Drive is an electrically-powered ­system intended to be used in general traumatology, as well as for small bone surgery in the hand, foot, spine, cranium and maxillofacial regions. The Irrigation Tubing provides cooling irrigation to the cutting tools whilst the irrigation clips allow fixation of the tubing.

Intended User

Patient Target Group Synthes manufactures surgical instruments are intended to prepare the site and aid in implantation of Synthes implants. The patient target group is based upon the ­implant devices rather than the instruments. Specific ­patient target group for the implants can be found in the respective Synthes implant instructions for use.

Expected Clinical Benefit Power Tools systems offer the following benefit to the patient and health care professionals compared to a manual approach: • Reduced effort to perform a surgery: The surgeon needs less physical force during the surgical procedure.

Potential Adverse Events As with all major surgical procedures, risks, side effects and adverse events can occur. While many possible ­reactions may occur, some of the most common adverse events include: • Systemic infection • Neurovascular injury • Thermal necrosis

The Electric Pen Drive is intended to be used by qualified health care professionals e.g. surgeons, operating room staff, and individuals involved in preparation of the device.

Indications The Electric Pen Drive system does not have any product specific indications. Synthes manufactures surgical instruments are intended to prepare the site and aid in implantation of Synthes implants. The indications are based upon the implant devices rather than the instruments. Specific indications for the implants can be found in the respective Synthes implant instructions for use. Electric Pen Drive • Instructions for Use

3

Introduction General Information

Unusual Transmissible Pathogens

Safety Instructions

▲  WARNING:

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.

Surgical patients identified as at risk for Creutzfeldt-Jakob disease (CJD) and related infections should be treated with single-use instruments. Dispose of instruments, power tools and attachments used, or suspected to have been used, on a p ­ atient with CJD after surgery by incineration and/or follow current national recommendations.

Locating of the Instrument or Fragments of Instruments ▲  WARNING: 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 imaging device (e.g. CT, Radiation ­De­vices, etc.) can aid in locating the fragments and/or components of the instrument.

Treatment before Device is used Sterile Devices: The devices are provided sterile. Remove products from the package in an aseptic manner. Store sterile devices in their original protective packaging, and do not remove them from the packaging until immediately before use. Prior to use, check the product expiration date and verify the integrity of the sterile packaging by visual inspection: • Inspect the entire area of the sterile barrier package, and the sealing, for completeness and uniformity. • Inspect for the absence of holes, channels or voids of the sterile barrier package and the sealing. Do not use, if the package is damaged or expired. Non-Sterile Devices: ▲  WARNING: Before first and every use and prior to returning for service, power tools and their accesso­ries/attachments, excluding consoles, foot switches and cables of the foot switch (05.001.022), have to be run through the complete reprocessing procedure. Protective covers and films must be fully removed before sterilization.

4

Instructions for Use • Electric Pen Drive

Do not use this equipment in the presence of oxygen, ­nitrous oxide or a mixture consisting of flammable anesthetic and air. Check instruments for correct adjustment and function­ ing prior to every use. For the surgical medical device to function properly, ­Synthes recommends that it is cleaned, disinfected 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. We recommend using new Synthes cutting tools for ­every surgical procedure. 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. Check proper operation of the tool before using it on the patient. To prevent overheating, always respect the specified Duty Cycles. For important information regarding electromagnetic compatibility (EMC), please refer to the chapter “System Specifications” in this manual. The tool is classified as type B against electrical shock and leakage current. The tool is suitable for use on ­patients in accordance with IEC 60601-1.

▲  WARNINGS: • For safety reasons, please read the IFU carefully before using Electric Pen Drive. • Do not use any apparently damaged components. • Do not use any component if the packaging is ­damaged. • Always wear personal protective equipment (­PPE) including safety goggles when handling the Electric Pen Drive system. • 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 position . • Should the device drop on the floor and have ­visible defects, do not use it anymore and send it to the Synthes Service Center. • Using the Electric Pen Drive outside the specified electromagnetic environment may lead to ­malfunction (e.g. unintended start or stop of the product). • 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. • To ensure a long service life and reduce repairs, the handpieces, attachments and lids must be ­lubricated after each use. • Observe the safety instructions and warnings stated in the instructions when working with attachments and cutting tools. Only use original Synthes attachments and tools. Damage resulting from the use of attachments from other manufacturers is not covered by the warranty. ▲  Precautions: • Always control the temperature of the system to prevent overheating and possibly harming the ­patient or user. • Cutting tools must be cooled with irrigation fluid to prevent heat necrosis. For this purpose, use ­either the integrated irrigation function or irrigate manually. • Always have a back-up system to prevent problems in case of deficient system.

Accessories/Scope of Delivery The main components of the Electric Pen Drive (EPD) System are the handpiece, hand switch, foot switch, console, electric cables as well as attachments and ­accessories. An overview of all components belonging ­ to the Electric Pen Drive System can be found in the chapter “Ordering Information”. For using the EPD System the following components are a must: • Electric Pen Drive (05.001.010) • Hand Switch (05.001.012) or Foot Switch (05.001.016) with the Cable Foot Switch-Console (05.001.022) • Console (05.001.006 or 05.001.002) • Cable Electric Pen Drive – Console (05.001.021 or 05.001.025) • At least one attachment belonging to the system and a 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. 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 a Maintenance Unit (05.001.099). No oils from other manufacturers may be used. Only the Synthes Maintenance Oil or Synthes Maintenance Spray 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. ▲  WARNINGS: • Only lubricate the handpieces and attachments when clean. • To ensure a long service life and reduce repairs, the handpieces and attachments must be lubricated after each use.

Electric Pen Drive • Instructions for Use

5

Introduction General Information

Combination of Medical Devices Synthes has not tested the compatibility with devices produced by other manufacturers and assumes no ­liability in such instances.

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.

Servicing ▲  WARNING: 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 use, neglected or unauthorized maintenance.

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 office.

6

Instructions for Use • Electric Pen Drive

Introduction

Explanation of Symbols

Explanation of the general symbols used

S9

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

IP X4

Caution Read the provided instructions for use before operating the device. Indicates that the device complies with the classification type B against electrical shock and electrical leakage current. The device is suitable for use on patients as defined by IEC 60601-1. Non-Ionizing Electromagnetic Radiation (RF Symbol) Product is UL classified to the requirements of both the United States and Canada.

0123 EC REP

The device meets the requirements of the Medical Device Regulation (EU) 2017/745.

Duty cycle type according to IEC 60034-1 Ingress protection rating according to IEC 60529. Locked symbol. Drive Unit is off for safety. Do not re-use Do not re-sterilize Double Sterile Barrier System Single Sterile Barrier System Manufacturer Manufacturing date Non sterile Sterilized using ethylene oxide Sterilized using irradiation Keep away from sunlight

European Authorized Representative

Keep dry

The European directive 2012/19/EU on waste electrical and electronic equipment (WEEE) CdappliesMH to this device. This device contains materials that should be disposed of in accordance with environment protection requirements. Please observe national and local regulations. Indicates Environment Friendly Use Period of 10 years in China.

Temperature limitation

Indicates Environment Friendly Use Period of 50 years in China. Relative humidity Atmospheric pressure

Reference number Lot number Serial number Material Packaging unit ISO 7000-2794 (2009-02) Expiration date Medical Device in the European Community/Union INMETRO Ord. 350 certified

Do not use if package is damaged.

Electric Pen Drive • Instructions for Use

7

Consoles

Standard Consoles

The Electric Pen Drive (05.001.010) can be supplied with the Standard Console (05.001.006) or with the Basic Console without integrated irrigation system (05.001.002).

1

2

5

6

10

3

Standard Console with irrigation (05.001.006) 1

Slide control for adjusting the maximum speed for 1 2 Slide control for adjusting the maximum speed for 2 3 Selection switch for irrigation 4 Connection for Adapter for Colibri * 5 Connection for Electric Pen Drive and Small Electric Drive 1** 6 Connection for Electric Pen Drive and Small Electric Drive 2** 7 Connection for Foot Switch 8 Twist lock for irrigation pump 9 Adjustment knob for irrigation flow rate 10 LED Irrigation Ready (Activation with Foot Switch)

4

7

8

9

Basic Console Basic Console (05.001.002)

1

1

Slide control for adjustment of the maximum speed for 1 4 Connection for Adapter for Colibri * 5 Connection for Electric Pen Drive and Small Electric Drive 1** 7 Connection for Foot Switch

4

* T  his connection is not of use anymore since the Adaptor for Colibri is no ­longer available. ** The Small Electric Drive is no longer available.

8

Instructions for Use • Electric Pen Drive

5

7

Consoles

Set-up of Consoles

Color Coding Set (60038602) A color coding set is supplied with every console. Each set contains 3 text stickers, 8 silicone rings in 3 colors (red, blue and white) and 8 stickers of the colored rings. The stickers and silicone rings can be used to indicate on the console and the cables how the system has to be ­assembled.

Content of Set No. 60038602

Set-up Before the initial operation of the device, make sure that the power switch (11) is set to position 0. Only connect the console to the power supply with the cable provided via the power plug socket (12) and set the power switch to position 1 (ON). The LED marked with on the front of the console signals the proper operation of the console. If the LED flashes, the console must be sent in for maintenance.

13 11 14 12

A potential equilization connector (13) for an equipotential earth plug is integrated in the console. Existing equipotential earth plugs can be connected there. (14) Fuses: 223AF/250V, Breaking Capacity 1500A

Electric Pen Drive • Instructions for Use

9

Consoles Set-up of Consoles

Mounting cables on consoles To mount the respective cables on the consoles, position the nose on the plugs flush with the groove on the plug sockets and insert the plugs. For improved orientation, red dots are provided on the plug and socket that must face upward when connecting the cable.

Removing cables To remove the plug, grasp the release sleeve, pull back and remove. The connections 4–7 (page 7) are used to connect the following devices: (4): C  onnection for a Colibri/Small Battery Drive handpiece (5 and 6): C  onnection for an Electric Pen Drive and Small Electric Drive (7): Connection for the Foot Switch Connections not used can be sealed off with the protective caps provided. ▲  WARNING: Do not place the console in the sterile field. ▲  Precautions: • Do not lay textiles or objects under the console. These can be sucked up and block the ventilation inlet. • Do not block the ventilation opening on the back of the console with any object. • Only place consoles on smooth and flat surfaces. • Do not hang the irrigation liquid directly above the console to prevent liquid from dripping on the console. • Do not pull the cable! Always activate the release sleeve. • Ensure that the power cord can always be disconnected immediately from mains supply.

10

Instructions for Use • Electric Pen Drive

Consoles

Speed Regulation

Functions of the Standard Console (05.001.006) and the Basic Console (05.001.002) Adjustment of the maximum speed (1, 2) Speed is automatically optimized and adjusted for each attachment; for certain attachments it is however recommended that you reduce the maximum speed of the connected handpiece. Adjustment can be performed in increments of 25 % with the slide controls for adjustment of maximum speed. It is recommended using this feature for high speed burrs. A letter code on each burr indicates the maximum speed specified by Synthes. Marking

Console Setting Pen 60k

A

100%

B

100%

C

75%

D

50%

E

25%

This is also explained by symbols on the supplied adhesive foil. The adhesive foil can be applied to the console as a reference aid.

Electric Pen Drive • Instructions for Use

11

Consoles

Irrigation

Function of the Standard Console (05.001.006)

3.2 3.3

3.1

3.5

3.4

The function of the Standard Consoles described in the following is not available on the Basic Console. Irrigation (3) With the integrated irrigation system, tools can be cooled to prevent tissue necrosis affected by excess heat. Irrigation nozzles for the attachments and sterile irrigation tubes are available for the irrigation system. In addition to the OFF position (position 3.1), there are two operating positions for Pen 1 and Pen 2: constant and variable irrigation (refer to Figure 3). If constant irrigation for Pen 1/Pen 2 is chosen, a c ­ onstant quantity of irrigation liquid will be released ­for Pen 1/Pen 2. A constant flow rate between 0 and 100 ml/min (0 and 3.4 oz/min) can be adjusted with the adjustment knob (9) for the irrigation flow rate (position 3.3/3.5). If variable irrigation for Pen 1/Pen 2 is chosen, the flow rate will be directly proportional to the speed selected on the Hand or Foot Switch, i.e. the higher the selected speed, the higher is the irrigation flow rate. The maximum flow rate can be set between 0 and 100 ml/min (0 and 3.4 oz/min) with the adjustment knob (9) for the irrigation flow rate (position 3.2/3.4). The LED lights up if the irrigation is activated (10) on the foot switch. Please refer to the chapter of the Foot Switch for a detailed explanation on how to activate or deactivate the irrigation.

12

Instructions for Use • Electric Pen Drive

3.1 Irrigation OFF 3.2 Variable irrigation for Pen 1 VAR 3.3 Constant irrigation for Pen 1 CON 3.4 Variable irrigation for Pen 2 VAR 3.5 Constant irrigation for Pen 2 CON

10

Irrigation Tube Set (05.001.178.01S) and Clips for Irrigation Tube Set (05.001.179.05S), Inserting Irrigation Tube 1. Remove the sterile Irrigation Tube (Fig. 1) from the sterile package. 2. Secure the attachment specific Irrigation Nozzle on the attachment (Fig. 2) used. 3. Fit the irrigation tube on the Irrigation Nozzle used first and then fix it with the clips (Fig 3) on the cable. 4. Route the Irrigation Tube end into the non-sterile area and open the twist lock for the irrigation pump in the direction of the arrow. 5. Insert the Irrigation Tube in the pump in accordance with the marking (see Fig. 4) and close the twist lock. 6. Remove the protective cap from the cannula and connect cannula to irrigation bag. When doing so, make sure that the connection nipple of the cannula is not touched by non-sterile persons while securing irrigation nozzle to the attachment. The vent of the spike has to be open when the irrigation is used. Push the Irrigation Nozzles for the Burr Attachments and Reciprocating Saw Attachment as far as necessary over the attachment from the front.

Fig. 1

Fig. 2

Fig. 3

Push the Irrigation Nozzle for the Sagittal Saw Attachment onto the attachment from the rear (from the ­attachment coupling side) before mounting the attachment on the handpiece. ▲  WARNING: Observe the sterile packages prior to usage for visual moisture or dampness and if found on or within the pack, the product (05.001.178.01S, 05.001.179.05S) should be disposed.

Fig. 4

Electric Pen Drive • Instructions for Use

13

Electric Pen Drive System

System Electric Pen Drive 60,000 rpm (05.001.010)

1 2 3 4 5 6 7

Adjustment sleeve Release sleeve for attachment Cable IN/OUT position LOCK position Forward position (clockwise) Reverse position (anti-clockwise) Lock slide for adjustment sleeve

Turning the adjustment sleeve

5

2 3

6

1

4

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 in the direction indicated by the arrow. After having reached the desired position release the lock slide (7) and the adjustment sleeve (1) is locked in the desired position.

Mounting cable on handpiece Move the adjustment sleeve (1) on the handpiece into the position cable IN/OUT (3). Align the groove on the plug with the notch in the sleeve and insert the plug. Turn the adjustment sleeve into the LOCK position (4). The cable is now firmly locked to the handpiece and the handpiece is in locked mode. To remove it again, move the adjustment sleeve (1) into the cable IN/OUT position (3) and remove the cable.

FWD/REV switchover By turning the adjustment sleeve into the forward position (5), the handpiece can be switched into a clockwise operating direction. In the reverse position (6) the handpiece can be operated in an anti-clockwise ­direction. In addition to locking the cable, the LOCK position (4) is used for safety switch-off when changing attachments and tools prevent accidental start-up of the unit. For instructions on mounting the attachments see page 16. Either a Hand Switch (page 14) or a Foot Switch (page 15) can be used for speed control.

14

Instructions for Use • Electric Pen Drive

7 ▲  WARNINGS: • Do not place the handpiece on magnetic covers or in the immediate vicinity of other magnetic objects. This can activate the handpiece. • Ensure secure fixation of the cables, hand switch, irrigation tube, clips, attachment and/or the cutting tool. Furthermore, ensure that the attachment and cutting tool coupling are not worn and closed. Replace damaged or worn components. Only use original Synthes devices. • HF (= high frequency) equipment for tissue coagulation can cause electromagnetic interferences and inadvertently activate the Electric Pen Drive – ­cables should be separated as far as possible. ▲  Precaution: When two Electric Pen Drive handpieces are connected and the speed is controlled with the Foot Switch, one handpiece must be switched to LOCK . Otherwise both handpieces will be blocked for safety reasons. In all other cases, the first activated device functions. As long as this device is activated, all others are deactivated.

Electric Pen Drive System

Hand Switch (05.001.012)

1 2 3 4 5

Positioning arrow Pull-out finger rest Positioning arrow Guide groove Locking switch

5

2

1

Mounting the Hand Switch on the handpiece (05.001.010) 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.

3

4

Removing To remove the Hand Switch, grasp the lever and pull it away upwards.

Operation 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).

Electric Pen Drive • Instructions for Use

15

Electric Pen Drive System

Foot Switch, 1 Pedal (05.001.016)

Connecting the Foot Switch to a console The Foot Switch can be connected to the console with the Foot Switch Cable (05.001.022). To insert the plugs, align the red dots on the plugs with those on the sockets and insert the plug. A second foot switch can be connected with the second socket in the foot pedal. Use the cable (05.001.022) for this purpose. However, this is not possible in combination with the basic console.

1

2

The second socket is covered with a protective cap on delivery; this can be removed if necessary.

Disconnecting a Foot Switch Grasp the respective plug by the release sleeve, pull back and remove.

Operation The speed can be continuously adjusted with the pedal (2). Briefly pressing the irrigation button (1) connects or disconnects the irrigation. In the ON position the setting preselected with the irrigation selection switch on the console is activated. The LED lights up if the irrigation is activated on the foot switch. If the user holds this button down, the irrigation quantity set with the irrigation flowrate adjustment knob (page 7) is supplied until the button is released. This function is independent of the position selected on the irrigation selection switch (page 11) and of the activation of the pedal (2) or Hand Switch (page 14). ▲  WARNING: When the cable is not connected properly to the foot switch, it is possible that the handpiece is activated without pressing the foot switch.

16

Instructions for Use • Electric Pen Drive

1 Irrigation ON/OFF button 2 Pedal

Attachments

General Information

Mounting the attachments on the ­handpieces (05.001.010) 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 clockwise until it disengages. Hold the attachment upward while doing so. Then remove the attachment.

Attachments and accessories For easier change of burrs, without having the Burr ­Attachment or Craniotome Attachment connected to the handpiece, the Handle for change of instruments (05.001.074) can be used. ▲  WARNINGS: • Observe the safety instructions and warnings stated in the instructions when working with a­ ttachments and cutting tools. Only use original Synthes attachments and tools. Damage resulting from the use of attachments and cutting tools from other manufacturers is not covered by the warranty. • After inserting a cutting tool, always check that it is properly seated by pulling it. ▲  Precaution: Always position the attachment head with the fitted cutting tool away from the body in o ­ rder to avoid injury.

Electric Pen Drive • Instructions for Use

17

Attachments

Drill Attachments

Drill Attachments (05.001.030– 05.001.032, 05.001.044)

1

Speed drill attachments: approx. 1,800 rpm The system includes straight Drill Attachments with Mini Quick, J-Latch and AO/ASIF Coupling and a 45° cannulated AO/ASIF Drill Attachment.

1

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

Mounting and removing tools Lock unit. Pull back the release sleeve and insert/remove the tool. 1 Release sleeve

Drill Attachment 45°, cannulated, with Jacobs Chuck (05.001.120) Speed drill attachments: approx. 1,800 rpm 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 and 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. ▲  WARNING: To ensure secure fixation of the instrument, make sure the toothed rims on the drill chuck and key are not worn. Replace damaged or worn components. Only use original Synthes key. 18

Instructions for Use • Electric Pen Drive

1 Release sleeve

1

1

Drill Attachment 90°, short (05.001.035) and long (05.001.036) with Mini Quick Coupling Speed: approx. 1,800 rpm

1

Due to their very small angled head the 90° Drill Attachments enable good visibility during operations with ­narrow access (e.g. intra-oral, shoulder etc.).

Mounting and removing tools

1 Slide

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 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.

1 Release sleeve

1

Mounting and removing tools 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 and insert/remove the tool. ▲  Precaution: The handpiece must be in FWD ­oscillating drill attachment.

position to use the

Electric Pen Drive • Instructions for Use

19