Electric Pen Drive 05.001.000 Instructions for Use June 2010

Table of Contents

Introduction

Operating Instructions

Product Information

Indications

2

Specifications

3

Drive Unit

15

Hand Switch

17

Consoles

23

Foot Switch

32

Drilling Speed Attachments

38

Screw Insertion Attachments

41

K-Wire Attachment

42

Sawing Attachments

43

Burring Speed Attachments

48

Light Adaptor for Small Battery Drive

52

Sterilization

54

Troubleshooting

56

Set Lists

58

Cutting Tools

66

Synthes

Indications

The Electric Pen Drive is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive, and spine surgery.

Drilling

K-wire insertion

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Synthes Electric Pen Drive User’s Manual

Specifications - System

The device complies with the following standards: IEC 60601-1/60601-1/60601-1-2/60601-1-4 IEC 61000-6-1/61000-6-2/61000-6-3/6000-6-4 Medical Electrical Equipment UL 60601-1 With regard to electrical shock, fire, mechanical hazards, only in accordance with UL 60601-1 and CAN/CSA C22.2 No. 601.1 Environmental conditions Operation

Transportation and storage

Temperature

10° – 40°C 50° – 104°F

–20° – 50°C –4° – 122°F

Relative humidity

30%– 75%

10%– 75%

Atmospheric pressure

500 – 1,060 hPA 0.5–1.06 bar

500 – 1,060 hPA 0.5–1.06 bar

Duty cycle Intermittent operation

Xsec on

Ysec off

Cycles

Drill / Burr Attachments

30

30

unlimited

Reciprocating Saw Attachment

30

60

5 cycles

Oscillating Saw Attachment

25

60

5 cycles

Sagittal Saw Attachment

30

60

5 cycles

These recommendations for times of use for the attachments for Electric Pen Drive have been determined under average load with an ambient air temperature of 25°C (77°F). Generally, electrical systems can heat up if in constant use. For this reason, the duty cycle times listed above should be followed to allow the Drive Unit and attachment to cool down after constant use. If this is observed, the system will avoid overheating and possibly harming the patient or user. After the above indicated number of cycles, the respective attachments must be allowed to cool down for 30 minutes. The user is responsible for following the duty cycles indicated. If longer periods of constant use are required, an additional Drive Unit and / or attachment should be used. Caution – Carefully observe the above recommended duty cycles. – Always use new cutting tools to prevent heating of the system due to reduced cutting performance. – For oral surgery, it is recommended to prevent any contact of warm components with soft tissues as temperatures even around 45°C may damage the lips and oral mucosa. – Careful maintenance of the system will reduce heat development in the Drive Unit and the attachments. The use of the Synthes Maintenance Station (05.001.099) is strongly recommended. – The Electric Pen Drive should not be stored or operated in an explosive atmosphere.

Synthes

3

Specifications - Standard Console with Irrigation (05.001.000)

Specifications – Weight: 5.4 kg (12 lbs) – Dimensions: 250 mm x 155 mm x 175 mm (9.8 in x 6.1 in x 6.9 in) – Operating voltage: 100 VAC–240 VAC, 50/60 Hz – Degree of protection: IP X0 Slide control For adjusting maximum speed for Drive Unit 2

Selection switch For torque limiting

Slide control For adjusting maximum speed for Drive Unit 1

Selection switch For irrigation

ON/OFF LED

Connector For Light Adaptor for Small Battery Drive

Flow rate adjustment knob For irrigation

Connector For Foot Switch

Connector For Drive Unit 1

Irrigation pump

Connector For Drive Unit 2

Additional instrument 05.001.001* Standard Console without irrigation

The standard console is also available without the pump module. 4

Synthes Electric Pen Drive User’s Manual

* Also available

Specifications - Basic Console (05.001.002)

The Basic Console includes connectors for one Drive Unit, a Foot Switch and the Light Adaptor for Small Battery Drive. It includes speed control for the Drive Unit but does not offer torque limiting or irrigation options.

Connector For Drive Unit

ON/OFF LED

Connector For Foot Switch

Connector For Light Adaptor for Small Battery Drive

Synthes

5

Specifications - Electric Pen Drive, 60,000 rpm (05.001.010)

Specifications – Weight: 183 g (6.45 oz) – Length: 130 mm (5.1 in) – Clockwise and counterclockwise rotation – Continuously variable speed: 0 to 60,000 rpm – Degree of protection: IP 54 – Removable variable-speed Hand Switch controls rotational speed – Attachment release ring facilitates one-handed insertion/removal of attachments – Mode switch turns Drive Unit to off / lock ( ) for safety during Drive Unit and / or attachment exchange, selects clockwise ( ) or counterclockwise ( ) rotation, and allows cable insertion/removal ( ). – Locking mechanism prevents inadvertent changes to mode switch Important: – Do not lay the Drive Unit on magnetic sterile covers or in the immediate vicinity of other magnetic objects. This could activate the Drive Unit. – When two 60,000 rpm Drive Units are connected and the speed is controlled with the Foot Switch, one Drive Unit must be switched to LOCK ( ). Otherwise, neither of the Drive Units 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 (including the Small Battery Drive). – When a 90,000 rpm Electric Pen Drive and a 60,000 rpm Electric Pen Drive are connected simultaneously, the 90,000 rpm Electric Pen Drive only works if the 60,000 rpm Electric Pen Drive is set to the LOCK ( ) position on the mode switch. Otherwise the 60,000 rpm Electric Pen Drive works.

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Synthes Electric Pen Drive User’s Manual

Cable insertion

Locking mechanism for mode switch

Forward (clockwise)

Reverse (counterclockwise)

Lock (Drive Unit off)

Cable insertion/removal

Specifications - Electric Pen Drive, 90,000 rpm (05.001.011)

Specifications – Weight: 124 g (4.4 oz) – Length: 102 mm (4 in) – Clockwise and counterclockwise rotation – Continuously variable speed: 0 to 90,000 rpm – Degree of protection: IP 54 The 90,000 rpm Electric Pen Drive can only be operated with a Foot Switch. The FWD/REV changeover must to be done with the 2-pedal Foot Switch (05.001.017). The cable is permanently fixed to the pen. To use the 90,000 rpm Electric Pen Drive, you need a console with the latest software. Those consoles are identifiable with the following features: Serial number: – Higher than 00773 for the Standard Console with irrigation (05.001.000) – Higher than 01152 for the Standard Console without irrigation (05.001.001) – Higher than 0336 for the Basic Console (05.001.002) – If a console has a lower serial number than mentioned above, but has a round, green sticker on the bottom plate label of the console, the console has already been upgraded to the latest software version. Consoles with a lower serial number and without a sticker on the bottom plate, must be sent to Synthes customer service for a software update, for use with the 90,000 rpm Electric Pen Drive. Important: – Only the Burr Attachments are compatible with this Drive Unit. – The Hand Switch cannot be used. – It is not possible to use two 90,000 rpm Electric Pen Drives. If two of them are plugged in, neither of them will work for safety reasons. – When a 90,000 rpm Electric Pen Drive and a 60,000 rpm Electric Pen Drive are connected simultaneously, the 90,000 rpm Electric Pen Drive only works if the 60,000 rpm Electric Pen Drive is set to the LOCK ( ) position on the mode switch. Otherwise the 60,000 rpm Electric Pen Drive works.

Synthes

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Specifications - Hand Switch (05.001.012) and Foot Switches (05.001.016, 05.001.017)

Hand Switch – May be removed without disconnecting the cable from the Drive Unit – Allows variable speed control of the Drive Unit – Includes a safety switch and pull-out finger rest

Pull-out finger rest

Safety switch

Positioning arrow

8

Synthes Electric Pen Drive User’s Manual

Foot Switch (05.001.016) – Dimensions: 220 mm x 160 mm x 150.5 mm (8.7 in x 6.3 in x 5.9 in) bar included – Degree of protection: IP X8 – Allows variable speed control of the Drive Unit – Includes an irrigation ON/OFF switch Foot Switch, 2 pedals (05.001.017) – Dimensions: 350 mm x 210 mm x 160 mm (13.8 in x 8.3 in x 6.3 in) bar included – Degree of protection: IP X8 – Allows variable speed and directional control of the Drive Unit – Includes an irrigation ON/OFF switch

Irrigation ON/OFF switch

REV

FWD

Pedal

Irrigation ON/OFF switch

Synthes

9

Specifications - Attachments for Electric Pen Drive

Drilling Attachments The drilling speed attachments are geared to decrease the maximum speed from 60,000 rpm to 1,800 rpm. 05.001.030 05.001.031 05.001.032 05.001.110

Drill Attachment, mini quick coupling Drill Attachment, J-latch coupling Drill Attachment, AO coupling Drill Attachment, hex coupling

Function: – Accept drill bits and burrs with mini quick, J-latch, hex, and AO couplings

45° Drill Attachments 05.001.042 45° Drill Attachment, mini quick coupling 05.001.043 45° Drill Attachment, J-latch coupling 05.001.044 45° Drill Attachment, AO coupling Function: – Accept drill bits and burrs with mini quick, J-latch and AO couplings

90° Drill Attachments 05.001.035 90° Drill Attachment, short, mini quick coupling 05.001.036 90° Drill Attachment, long, mini quick coupling Functions: – Improve visibility during operations with narrow access – Accept drill bits and burrs with mini quick coupling

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Synthes Electric Pen Drive User’s Manual

45° Drill Attachment, cannulated 05.001.120 Drill Attachment with Jacobs chuck Speed: – approx. 1,800 rpm Function: – 1.6 mm cannulation permits the use of this attachment for drilling and reaming over K-wires (e.g. for cannulated screws and for cup and cone technique)

45° Oscillating Drill Attachment 05.001.033 45° Oscillating Drill Attachment, mini quick coupling Frequency: – 3,200 oscillations/minute Functions: – Accepts drill bits and burrs with mini quick coupling – Prevents tissue and nerves from wrapping around the drill bit or burr

Screw Insertion Attachments 05.001.028 Screw Attachment, AO coupling 05.001.029 Screw Attachment, hex coupling 05.001.034 Screw Attachment, mini quick coupling Speed: – 0 to 400 rpm Function: – Accept mini quick, hex and AO coupling screwdriver shafts

K-Wire Attachment 05.001.037 K-Wire Attachment Speed: – 0 to 2,700 rpm Function: – To insert/remove Kirschner wires 0.6 mm to 1.6 mm (0.02 in. to 0.06 in.) in diameter, of any length

Synthes

11

Specifications - Attachments for Electric Pen Drive continued

Sawing Attachments

05.001.038

Oscillating Saw Attachment

Frequency: – 22,000 oscillations/minute Function: – Accepts Synthes crescentic and mandibular saw blades for Electric Pen Drive

05.001.039

Sagittal Saw Attachment

Frequency: – 22,000 oscillations/minute Function: – Accepts Synthes sagittal saw blades for Electric Pen Drive

05.001.040

Reciprocating Saw Attachment

Frequency: – 18,000 oscillations/minute Function: – Accepts Synthes reciprocating saw blades and Synthes rasps for Electric Pen Drive

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Synthes Electric Pen Drive User’s Manual

Burring Speed Attachments The burring speed attachments transfer the speed of the Drive Unit, with a maximum speed of 60,000 rpm (with 05.001.010) and 90,000 rpm (with 05.001.011). Speed: – 0 to 60,000 rpm and 0 to 90,000 rpm Function: – Accept Synthes short, medium and long burrs for Electric Pen Drive 05.001.045

Burr Attachment, short

05.001.048

Burr Attachment, short, angled

05.001.046

Burr Attachment, medium

05.001.049

Burr Attachment, medium, angled

05.001.047

Burr Attachment, long

05.001.050

Burr Attachment, long, angled

Synthes

13

Specifications - Attachments for Electric Pen Drive continued

Burring Speed Attachments continued

05.001.063

Burr Attachment, XL, angled

05.001.055

Burr Attachment, XXL, angled

Light Adaptor for Small Battery Drive 05.001.108 Light Adaptor for Small Battery Drive The Light Adaptor for Small Battery Drive allows the user to power the Small Battery Drive through the console.

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Synthes Electric Pen Drive User’s Manual

Operating Instructions - Drive Unit, 60,000 rpm (05.001.010)

Connecting the cable to the Drive Unit The Electric Pen Drive System offers various length cables to connect the Drive Unit to the console: Instruments 05.001.020* 2 meter cable 05.001.025* 3 meter cable 05.001.021

4 meter cable

Always slide the lock in the direction of the arrows prior to turning the mode switch. The lock will automatically return to the locked position. Ensure that the mode switch is in the cable insertion/removal ( ) position. Align the groove on the plug with the notch on the mode switch and insert the plug. Do not force the plug into the mode switch as this may damage the plug and/or the Drive Unit. Turn the mode switch into the lock ( ) position. The cable is now firmly locked in the Drive Unit and the Drive Unit is in the OFF mode. To remove the cable, return the mode switch to the cable insertion / removal ( ) position and pull gently on the plug.

* Also available

Synthes

15

Operating Instructions - Drive Unit, 60,000 rpm (05.001.010) continued

Forward and reverse modes The Electric Pen Drive can be used in clockwise or counterclockwise rotation. Changing the direction of rotation with the mode switch will affect operations with both the Hand Switch and the Foot Switch. Always slide the lock prior to turning the mode switch. For clockwise rotation, turn the mode switch to the forward ( ) position. For counterclockwise rotation, turn the mode switch to the reverse ( ) position. For safety, always turn the mode switch to the lock ( position while changing attachments or tools.

16

Synthes Electric Pen Drive User’s Manual

)

Attaching the Hand Switch to the Drive Unit Instrument 05.001.012

Hand Switch

Position the Hand Switch on the Drive Unit by aligning the positioning arrows on the Hand Switch and the positioning arrows on the Drive Unit, above the guide grooves.

Press down on the Hand Switch until it clicks into place on the Drive Unit.

Synthes

17

Operating Instructions - Drive Unit, 60,000 rpm (05.001.010) continued

Attaching the Hand Switch to the Drive Unit continued Correct position for the Hand Switch. The Synthes logo is in the upright position with the Hand Switch facing up (Figure 1). Incorrect position for the Hand Switch (Figure 2).

Figure 1 – Correct position

Figure 2 – Incorrect position

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Synthes Electric Pen Drive User’s Manual

Removing the Hand Switch from the Drive Unit To remove the Hand Switch, grasp the lever and pull it away from the Drive Unit.

Operating the Hand Switch For safety, slide the switch to the LOCK position during Drive Unit and/or attachment exchange.

Synthes

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