Electric Pen Drive 05.001.010 Instructions for Use April 2013

Table of Contents

Introduction

Consoles

Electric Pen Drive System

Attachments

General Information

3

Explanation of Symbols

5

Standard Consoles

6

Basic Console

7

Set-up of Consoles

8

Speed Regulation

10

Torque Limiting

11

Irrigation

13

Light Adapter for Colibri (05.001.108)

15

Electric Pen Drive 60,000 rpm (05.001.010)

16

Electric Pen Drive 90,000 rpm (05.001.011)

18

Hand Switch (05.001.012)

19

Foot Switch,1 Pedal (05.001.016)

20

Foot Switch, 2 Pedals (05.001.017)

21

General Information

22

Drill Attachments

23

Screw Attachments

25

Kirschner Wire Attachment

26

Saw Attachments

27

Burr Attachments

29

Adapter for Intra Coupling

31

Perforators

32

Craniotome Attachment

34

Electric Pen Drive

Instructions for Use

DePuy Synthes

1

Table of Contents

Cutting Tools

General Information

35

Care and Maintenance

General Information

36

Preparation for Cleaning and Disinfection

37

Cleaning and Disinfection

38

Maintenance and Lubrication

40

Inspection, Packaging, Sterilization and Storage

43

Repairs and Technical Service

44

Disposal

45

Troubleshooting

46

System Specifications

49

Electromagnetic Compatibility

Accompanying Documents

Ordering Information

59

Warning This description alone does not provide sufficient background for direct use of the product. Instruction by a surgeon experienced in handling this product is highly recommended.

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Electric Pen Drive

Instructions for Use

Introduction General Information

Intended use The Electric Pen Drive is an electrically-powered system to be used for treatment in general traumatology, as well as for surgery in the hand, foot, spine and maxillofacial regions and neurosurgery. Only use Synthes accessories to guarantee operational reliability of the Electric Pen Drive.

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.

Safety instructions The Electric 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 user of the product is responsible for proper use of the equipment during surgery.

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

For important information regarding electromagnetic compatibility (EMC) please refer to the chapter “System Specifications” in this manual.

If the Electric Pen Drive System is used in conjunction with an implant system make sure to consult the corresponding “Technique Guide”.

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. To ensure proper operation of the tool, use only Synthes original accessories. 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. Check proper operation of the tools before using it on the patient.

The tool is classified as type BF against electrical shock and leakage current. The tool is suitable for use on patients in accordance with IEC 60601-1. To ensure proper operation of the tool, Synthes recommends annual maintenance by a Synthes service center. The manufacturer shall assume no responsibility for damage resulting from improper operation or unauthorized maintenance of the tool.

Precaution: 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 ( ).

To prevent overheating, always respect the duty cycles for each attachment listed on page 52. 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.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Introduction General Information

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 (05.001.000, 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. For sterilization and storage two system-specific Vario Cases are recommended and available. For care and maintenance special tools are available, such as cleaning brushes, Synthes Maintenance Oil for EPD and APD, Maintenance Spray and a Maintenance Unit. No oils from other manufacturers may be used. Only Synthes oil may be used. Storage and Transport Please use the original packaging for dispatch and transport. If this is no longer available, please contact the Synthes office. The same environmental conditions apply for transport as for storage, see page 51. Warranty The warranty for the tools and accessories does not cover damage of any kind resulting from improper use, damaged seal and improper storage and transport. The manufacturer does not accept liability for damage resulting from repairs or maintenance carried out by unauthorized sites.

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Electric Pen Drive

Instructions for Use

Introduction

Explanation of Symbols

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 CSA 601.1, IEC 60601-1 and UL 60601 Do not immerse device in liquids.

The marked device shall only be used within a specified temperature range. The marked device shall be re-calibrated.

10PB

0123

Electric Pen Drive With regard to electrical shock, fire, mechanical hazards, only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1

2

Do not reuse Products intended for single use must not be re-used. 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 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.

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. The European directive 2002/96/EC on waste electrical and electronic equipment (WEEE) applies to this device. This device contains materials that should be disposed of in accordance with environment protection requirements. Please observe national and local regulations.

Electric Pen Drive

Instructions for Use

DePuy Synthes

5

Consoles Standard Consoles

The Electric Pen Drive (05.01.010 and 05.001.011) can be supplied with the Standard Console, or as an alternative with the Basic Console (without torque limiting function and irrigation). The Standard Console can alternatively be ordered without the torque limiting function. Standard Console with irrigation (05.001.000) 1 Slide control for adjusting the maximum speed for 1 2 Slide control for adjusting the maximum speed for 2 3 Selection switch for torque limiting 4 Selection switch for irrigation 5 Connection for Adapter for Colibri 6 Connection for Electric Pen Drive and Small Electric Drive 1 7 Connection for Electric Pen Drive and Small Electric Drive 2 8 Connection for Foot Switch 9 Twist lock for irrigation pump 10 Adjustment knob for irrigation flow rate

Standard Console with irrigation, without torque limiting (05.001.006) 1 Slide control for adjusting the maximum speed for 1 2 Slide control for adjusting the maximum speed for 2 4 Selection switch for irrigation 5 Connection for Adapter for Colibri 6 Connection for Electric Pen Drive and Small Electric Drive 1 7 Connection for Electric Pen Drive and Small Electric Drive 2 8 Connection for Foot Switch 9 Twist lock for irrigation pump 10 Adjustment knob for irrigation flow rate 11 LED Irrigation Ready (Activation with Foot Switch)

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Electric Pen Drive

Instructions for Use

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5

1

2

6

7

1

2

6

7

3

8

4

9

11

8

10

4

9

10

Consoles

Basic Console

Basic Console (05.001.002) 1 Slide control for adjusting the maximum speed for 5 Connection for Adapter for Colibri 6 Connection for Electric Pen Drive and Small Electric Drive 1 8 Connection for Foot Switch

1 1

Notes: – When returning the console for repair or maintenance, always send back the power cord. – For more details on the Small Electric Drive please refer to the separate manual and contact your Synthes representative for more information.

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Electric Pen Drive

6

Instructions for Use

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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.

Note: The silicone rings fixed to the cables have to be removed (moved backwards on the cable) before washing and fixed again before sterilization.

Content of Set No. 60038602

Set-up Before the initial operation of the device, make sure that the power switch (12) is set to position 0. Only connect the console to the power supply with the cable provided via the power plug socket (13) 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. A potential equilization connector (14) for an equipotential earth plug is integrated in the console. Existing equipotential earth plugs can be connected there. (15) Fuses: 2⳯3 AF / 250 VA Breaking Capacity 1500 A

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Electric Pen Drive

Instructions for Use

14 12 15 13

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 5 – 8 (page 6) are used to connect the following devices: (5): Connection for a Colibri / Small Battery Drive handpiece (6 and 7): Connection for an Electric Pen Drive and Small Electric Drive (8): Connection for the Foot Switch

Connections not used can be sealed off with the protective caps provided.

Precautions: – Do not place consoles directly against a wall, as console ventilation will be impaired. Maintain a distance of at least 3 cm. – Only place consoles on smooth surfaces. – Do not lay textiles or objects under the console. These can be sucked up and block the ventilation inlet. – Do not hang the irrigation liquid directly above the console to prevent liquid from dripping on the console. – Do not pull on the cable! Always activate the release sleeve. – The use of HF (= high frequency) equipment for tissue coagulation can cause electromagnetic disturbances – in this case the cables should be separated as far as possible.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Consoles

Speed Regulation

Functions of the Standard Consoles (05.001.000 and 05.001.006) and the Basic Console (05.001.002)

Adjustment of the maximum speed (1, 2) The speed is automatically optimally adjusted for each attachment; however the maximum achievable speed of the connected handpiece (incl. attachment) can be reduced in increments of 25% with the slide controls for adjusting the maximum speed (1, 2). This is above all very helpful when using the high-speed burr attachments to adjust the maximum speed given by Synthes for each burr. A letter code on the burrs indicates the maximum speed recommended for the respective burr.

Marking

Console Setting Pen 60k

Console Setting Pen 90k

A

100%

100%

B

100%

75%

C

75%

50%

D

50%

25%

E

25%

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.

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Electric Pen Drive

Instructions for Use

Consoles

Torque Limiting

Function of the Standard Console (05.001.000) The function of the Standard Console (05.001.000) described in the following is not available on the Standard Console without torque limiting (05.001.006) or on the Basic Console. Torque limiting (3) The Electric Pen Drive System enables screws to be directly implanted and tightened with the unit. This function is particularly advantageous with angularly stable screws which must be locked in the plate with a specified torque (e. g. Synthes LCP System).

a

b

c

d

For this purpose the torque must be calibrated in advance as follows: Connect a handpiece (05.001.010) with a cable to connection 2, picture a, and insert a Screw Attachment (05.001.028, 05.001.029, or 05.001.034; picture b). Guide the handpiece with the Screw Attachment into the Torque Calibration Unit (05.001.060–05.001.061) (see picture c) and set the torque limiting selection switch (3), picture d, to the calibration position (3.3). The handpiece now begins the calibration process as soon as either the Hand or Foot Switch is activated. Do not release the switch until the process has been completed.

3.1

3.2

3.3

3.1 Torque limiting OFF 3.2 Torque limiting ON 3.3 Calibration torque CAL

Remove the handpiece and set the torque limiting selection switch to the torque limiting ON position (3.2) to work with this function. The LED for torque limiting lights up when the calibration has been successfully carried out and the system is ready. To work without torque limiting again, set the selection switch to the torque limiting OFF position (3.1). The calibrated value is stored and can be reactivated in the ON position until the calibration has been carried out again, until the console is switched off or until the handpiece is removed from connection 2.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Consoles Torque Limiting

Precautions: – To guarantee a correct calibrated value, the Torque Calibration Units (05.001.060 and 05.001.061) shall only be used when their temperature is between 18 °C – 25 °C (64 °F – 77 °F) as showed on the symbol in picture e. – In case a calibration unit has been sterilized more than 10 times without being used, proceed with a test calibration before the first calibration. – The Torque Calibration Units have to be sent for re-calibration once a year (see picture f). – The calibration function is only possible with an Electric Pen Drive 60,000 rpm (05.001.010) on the pen connection 2 in the forward position . Note: Please ensure that the switch for the torque limiting function is set to the OFF position when it is not used. A wrong setting can lead to a malfunctioning of the system. To insert the screw, insert the screwdriver insert in the screw attachment and pick up the screw. Position the screw and activate the Foot or Hand Switch. In the torque limitation ON mode, the speed automatically only increases slowly to a predefined speed even with the Hand / Foot Switch completely pressed down. This enables perfect guidance of the screw. When locking the screw head in the plate, the Electric Pen Drive limits the torque to the previously calibrated torque and stops automatically.

Precautions: – The torque must be recalibrated before each operation. – Do not release the calibration unit during the calibration process. – If the LED for torque limiting flashes, consult the corresponding points in the troubleshooting section on page 47. – The Torque Calibration Units shall only be used when they have reached room temperature (18°– 25 °C, 64°–77 °F). Do not use the calibration units directly after sterilisation, when they are still hot. Otherwise the calibration result can be altered. – In case a calibration unit has been sterilized more than 10 times without being used, proceed with a test calibration before the first calibration.

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Electric Pen Drive

Instructions for Use

e

25° C 77° F

18° C 64° F

f

calibrate annually

Consoles

Irrigation

Function of the Standard Consoles (05.001.000 and 05.001.006) The function of the Standard Consoles described in the following is not available on the Basic Console. Irrigation (4) With the integrated irrigation system, tools can be cooled to prevent necrosis due to excess heat. Irrigation nozzles for the attachments and sterile irrigation tubes are available for the irrigation system. In addition to the OFF position (4.1), there are also 2 operating positions each for Pen 1 and Pen 2. In the positions 4.3/4.5 (constant irrigation for Pen 1 / Pen 2), a constant quantity of irrigation liquid is given off for Pen 1 / Pen 2. This constant flow rate can be adjusted between 10 and 100 ml / min (0.34 and 3.4 fl oz / min) with the adjustment knob for the irrigation flow rate (5).

4.2

4.3

4.1

4.5

4.4

4.1 Irrigation OFF 4.2 Variable irrigation for Pen 1 VAR 4.3 Constant irrigation for Pen 1 CON 4.4 Variable irrigation for Pen 2 VAR 4.5 Constant irrigation for Pen 2 CON

11 In the positions 4.2/4.4 (variable irrigation for Pen 1 / Pen 2), the flow rate is directly proportional to the speed selected on the Hand or Foot Switch, i.e the faster the Electric Pen Drive runs, the higher the irrigation flow rate. The maximum achievable flow rate can be set between 10 and 100 ml / min (0.34 and 3.4 oz / min) with the adjustment knob for the irrigation flow rate (5).

The LED lights up if the irrigation is activated (11) 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.

Bottle Holder

A Bottle Holder for Irrigation Fluid (05.001.007) is available for the standard consoles (05.001.000 and 05.001.006). It makes is possible to hang a bottle with irrigation fluid near the console.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Consoles Irrigation

Irrigation Tube Set (05.001.069.01S and 05.001.069.05S – clips included), 2 Irrigation Tube Set (05.001.178.01S and 05.001.178.05S) and Clips for Irrigation Tube Set (05.001.179.05S), 2 Inserting Irrigation Tube 1. Remove the sterile Irrigation Tube from the sterile package. 2. Secure the Irrigation Nozzle on the attachment used. 3. Fit the irrigation tube on the Irrigation Nozzle used first and then secure it with the clips 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. 2) 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.

Fig. 1

Push the Irrigation Nozzles for the Burr Attachments, Oscillating Saw Attachment and Reciprocating Saw Attachment as far as necessary over the attachment from the front. 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.

Note: The vent of the spike has to be open when the irrigation is used.

Fig. 2

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Electric Pen Drive

Instructions for Use

Consoles

Light Adapter for Colibri (05.001.108)

The Light Adapter for Colibri (05.001.108) is used to enable the use of the Colibri with the Electric Pen Drive Consoles (05.001.000, 05.001.006 and 05.001.002) Inserting Light Adapter for Colibri in drive unit Push the Adapter into the mounting shaft of the handpiece from below until it engages (Fig. 1). The shape of the Adapter prevents incorrect connection. Check the correct seating of the Adapter by pulling slightly on it. Removing Light Adapter for Colibri from drive unit Press the release buttons on the Colibri simultaneously with one hand and pull the Adapter out of the handpiece with the other hand (Fig. 2).

Fig. 1

Fig. 2

Connecting Adapter Cable to Console To connect the Adapter Cable to the Console, position the nose on the plug flush with the groove on the connection for the Colibri (see page 6) and insert the plug. For improved orientation, red dots are provided on the plug and socket which must face upward when connecting the cable.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Electric Pen Drive System Electric Pen Drive 60,000 rpm (05.001.010)

1 Adjustment sleeve 2 Release sleeve for attachment 3 Cable IN/OUT position 4 LOCK position 5 Forward position (clockwise) 6 Reverse position (anti-clockwise) 7 Lock slide for adjustment sleeve

5

2

Turning the 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 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 in the handpiece and the handpiece is in locked mode. To remove, 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 running 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 also 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 page 22. Either a Hand Switch (page 19) or a Foot Switch (page 20 / 21) can be used for speed control.

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Electric Pen Drive

Instructions for Use

3

4

7

1

6

Precautions: – Do not lay the handpiece on magnetic sterile covers or in the immediate vicinity of other magnetic objects. This could activate the handpiece. – 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 neither of the handpieces will function for safety reasons. – In all other cases, the first speed control device to be activated functions. As long as this device is activated, all others are deactivated (incl. Colibri). – When an Electric Pen Drive 90,000 rpm (05.001.011) and an Electric Pen Drive 60,000 rpm (05.001.010) are connected simultaneously, the Electric Pen Drive 90,000 rpm only works if the Electric Pen Drive 60,000 rpm is set to the LOCK position on the adjustment sleeve (1). Otherwise the Electric Pen Drive 60,000 rpm works. – HF (= high frequency) equipment for tissue coagulation can cause electromagnetic disturbances and inadvertently activate the Electric Pen Drive – cables should be separated as far as possible.

Electric Pen Drive

Instructions for Use

DePuy Synthes

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Electric Pen Drive System

Electric Pen Drive 90,000 rpm (05.001.011)

The Electric Pen Drive (05.001.011) can only be operated with a Foot Switch. The FWD/REV changeover has to be done with the Foot Switch (05.001.017). The cable is permanently fixed to the pen.

Precautions: – Only high-speed attachments such as Burr Attachments (05.001.045–05.001.050, 05.001.055), Craniotome (05.001.059) and Perforator (05.001.054) are compatible with this handpiece. – The Hand Switch (05.001.012) cannot be used. – It is not possible to use two Electric Pen Drives, 90,000 rpm (05.001.011). If two of them are plugged in, neither of them will work for safety reasons. – When an Electric Pen Drive 90,000 rpm (05.001.011) and an Electric Pen Drive 60,000 rpm (05.001.010) are connected simultaneously, the Electric Pen Drive 90,000 rpm only works if the Electric Pen Drive 60,000 rpm is set to the LOCK position on the adjustment sleeve. Otherwise the Electric Pen Drive 60,000 rpm works.

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Electric Pen Drive

Instructions for Use

Electric Pen Drive System

Hand Switch (05.001.012)

1 Positioning arrow 2 Pull-out finger rest 3 Positioning arrow 4 Guide groove 5 Locking switch

5

2

Instructions for Use

DePuy Synthes

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).

Precautions: – The marking ( / / / ) on the adjustment sleeve must face upwards when mounting the Hand Switch. The angled sections of the handpiece and the Hand Switch must run parallel with the Hand Switch mounted (see arrow in above picture). – Always remove the Hand Switch for sterilization. – The Hand Switch can only be used with Electric Pen Drive 60,000 rpm (05.001.010)!

Electric Pen Drive

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