Synthes Electric pen drive Instructions For Use Manual
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Synthes Electric pen drive Instructions For Use Manual

Synthes Electric pen drive Instructions For Use Manual

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Instructions
for Use
This publication is not intended for
distribution in the USA.
Instruments and implants
approved by the AO Foundation
Electric Pen Drive. Compact drive
with specific attachments for
a wide spectrum of applications.

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  • Page 1 Electric Pen Drive. Compact drive with specific attachments for a wide spectrum of applications. Instructions for Use This publication is not intended for distribution in the USA. Instruments and implants approved by the AO Foundation...

  • Page 3: Table Of Contents

    Set-up of Consoles Speed Regulation Torque Limiting Irrigation Light Adapter for Colibri (05.001.108) Electric Pen Drive System Electric Pen Drive 60,000 rpm (05.001.010) Electric Pen Drive 90,000 rpm (05.001.011) Hand Switch (05.001.012) Foot Switch,1 Pedal (05.001.016) Foot Switch, 2 Pedals (05.001.017) Attachments...
  • Page 4 Electromagnetic Compatibility Accompanying Documents Ordering Information 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. DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 5: Cutting Tools

    Safety instructions The user of the product is responsible for proper use of the The Electric Pen Drive System is only to be used for patient equipment during surgery. treatment after careful consultation of the instructions for use.
  • Page 6 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”.

  • Page 7: Explanation Of Symbols

    The marked device shall only be used within a Synthes does not recommend reprocessing con- specified temperature range. taminated products. Any Synthes product that has been contaminated by blood, tissue, and/or bodily The marked device shall be re-calibrated. fluids/matter should never be used again and should be handled according to hospital protocol.

  • Page 8: Standard Consoles

    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 irri- gation). The Standard Console can alternatively be ordered without the torque limiting function.

  • Page 9: Basic Console

    – 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 represen - tative for more information. Electric Pen Drive...

  • Page 10: Set-Up Of Consoles

    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: 2 3 AF / 250 VA Breaking Capacity 1500 A DePuy Synthes Electric Pen Drive Instructions for Use...
  • Page 11 – 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...

  • Page 12: Speed Regulation

    (1, 2). This is above all very helpful when using the high-speed burr attachments to adjust the maxi- mum speed given by Synthes for each burr. A letter code on the burrs indicates the maximum speed recommended for the respective burr.

  • Page 13: Torque Limiting

    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.
  • Page 14 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. DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 15: Irrigation

    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...
  • Page 16 (from the attachment coupling side) before mounting the attachment on the hand- piece. Note: The vent of the spike has to be open when the irriga- tion is used. Fig. 2 DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 17: Light Adapter For Colibri (05.001.108)

    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.

  • Page 18: Electric Pen Drive 60,000 Rpm (05.001.010)

    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 Turning the adjustment sleeve...
  • Page 19 – When an Electric Pen Drive 90,000 rpm (05.001.011) and an Electric Pen Drive 60,000 rpm (05.001.010) are con- nected 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). Other- wise the Electric Pen Drive 60,000 rpm works.

  • Page 20: Electric Pen Drive 90,000 Rpm

    – When an Electric Pen Drive 90,000 rpm (05.001.011) and an Electric Pen Drive 60,000 rpm (05.001.010) are con- nected 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.

  • Page 21: Hand Switch (05.001.012)

    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 Instructions for Use...

  • Page 22: Foot Switch,1 Pedal (05.001.016)

    (2) or Hand Switch (page 19). Precautions: – When using the Foot Switch (05.001.016) (1 pedal) with the Electric Pen Drive (05.001.011) the only operating mode possible is FWD. – When the cable is not connected properly to the foot switch, it is possible that the handpiece is activated with- out pressing the foot switch.

  • Page 23: Foot Switch, 2 Pedals (05.001.017)

    Foot Switch (2 pedals) (05.001.017). 3 Irrigation ON/OFF button Precautions: – When operating the Electric Pen Drive 60 000 rpm (05.001.010) with the Foot Switch (05.001.017) the oper- ating mode is defined by the pedal pressed down on the Foot Switch (05.001.017), i.

  • Page 24: General Information

    Handle for change of instruments (05.001.074) can be used. Precautions: – Only use Synthes saw blades, burrs and rasps while work- ing with the Electric Pen Drive attachments. The use of other tools voids the device warranty. – The drill, screws, saw attachments and the Kirschner wire attachment cannot be used with the Electric Pen Drive 90,000 rpm (05.001.011).

  • Page 25: Drill Attachments

    Insert/remove the tool. Close the chuck by turning the moving parts counterclockwise and tighten it by turning the key clockwise. Electric Pen Drive Instructions for Use DePuy Synthes...
  • Page 26 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 position to use the oscillating drill attachment. DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 27: Screw Attachments

    Mounting and removing tools Lock unit. Pull back the release sleeve and insert/remove the tool. Precaution: Always use an appropriate Torque Limiting device while inserting locking screws into a locking plate. Electric Pen Drive Instructions for Use DePuy Synthes...

  • Page 28: Kirschner Wire Attachment

    (1). After the lever is released, the Kirschner wire is automatically tensioned. To re-grasp, press the ten- sioning lever, pull back the unit along the Kirschner wire and then release the tensioning lever again. DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 29: Saw Attachments

    2 Mounting opening for saw blades 4. Release the clamping button. Precautions: – Saw blades cannot be re-sharpened. – Only use Synthes saw blades. The use of other saw blades voids the device warranty. Electric Pen Drive Instructions for Use...
  • Page 30 Attachments Saw Attachments Oscillating Saw Attachment (05.001.038) Frequency: approx. 16,000 osc./min The Oscillating Saw Attachment is used with Synthes cres- centic and 105° angled saw blades. 1 Release sleeve for saw blades Changing saw blades 2 Mounting opening for saw blades 1.

  • Page 31: Burr Attachments

    S, M or L on the burr shank is no longer visible. Information on handling burrs Synthes recommends using a new sterile burr for each oper- ation. This prevents health risks to the patient. Used burrs present the following risks: –...
  • Page 32 Information on handling cutting tools 1. Lock unit. Synthes recommends using a new cutting tool for each sur- 2. Turn the release sleeve (1) until it engages in the UNLOCK gery, as only then it can be ensured that the cutting tool position and remove the tool.

  • Page 33: Adapter For Intra Coupling

    Electric and Air Pen Drive System and the Adapter for Intra Coupling. Synthes does not assume any liability for misuse of any of the above mentioned products and consequences that may result from it.

  • Page 34: Perforators

    – It is recommended to cool the trepan burr during trepana- tion (use the irrigation nozzle 05.001.076). – Check function before each use of the perforator. – The user is liable for the surgical application. – Synthes recommends using new cutting tools for every surgery. Perforator Trepan Burr Protection Sleeve 05.001.054...
  • Page 35 – The user is liable to check the compatibility of the Perfora- tor with Hudson Coupling, the Irrigation Nozzle and the cutting tool used. – Synthes recommends using a new cutting tool for every surgery. Please also observe the recommendations of the supplier of the cutting tool regarding reprocessing / multiple use.

  • Page 36: Craniotome Attachment

    For this purpose, attach the Irrigation Tube (05.001.069.01S or 05.001.069.05S) to the nozzle built into the Dura Guard. – Only use Synthes Cranial Burrs. The use of other burrs voids the device warranty. – Avoid all side load on the burr and Dura Guard, as they may otherwise break.

  • Page 37: Electric Pen Drive Instructions For Use Depuy Synthes

    Cooling of Cutting Tools ing are indicated for cutting, shaping and smoothing of Synthes strongly recommends the use of an irrigation nozzle, bones, teeth and metal in a wide variety of surgical proce- the irrigation tube set (see page 14) and cooling fluid to cool dures, including but not limited to general orthopaedic cutting tools.

  • Page 38: Care And Maintenance General Information

    Gentle care and mainte- follow current national recommendations. nance with proper lubrication can substantially increase the reliability and life of the system components. Synthes recom- Important: The clinical processing instructions provided have mends annual servicing and inspection by the original manu- been validated by Synthes for preparing a non-sterile Synthes facturer or its exclusive sales outlets.

  • Page 39: Preparation For Cleaning And Disinfection

    Power equipment may not be cleaned ultrasonically. – Do not use pointed objects for cleaning. – Unlock or open instruments to allow for penetration of cleaning solution. Electric Pen Drive Instructions for Use DePuy Synthes...

  • Page 40: Cleaning And Disinfection

    Fig. 3: Cleaning Brush nozzles with a syringe using cold tap water. Rinse the unit and accessories with de-ionized or purified water. 8. Dry the handpiece and attachments with a clean, soft and lint-free cloth. DePuy Synthes Electric Pen Drive Instructions for Use...
  • Page 41 1. Do not machine wash the Console and the Foot Switch. – For automated cleaning, also consult the brochure See Manual Cleaning and Disinfection (chapter “Prepara- “Synthes Power Tools – Machine Washing Recommenda- tion for cleaning”). tions” (036.000.101). 2. Make sure that the surfaces of the cable, which are –...

  • Page 42: Maintenance And Lubrication

    Care and Maintenance Maintenance and Lubrication Maintenance – with the Synthes Maintenance Unit Synthes recommends the use of the Synthes Maintenance Unit (05.001.099) developed for oiling the handpiece and attachments. With the Maintenance Unit an optimal mainte- nance of the system over the entire service life can be en- sured.
  • Page 43 1. Perform maintenance on the handpiece following every use with the Synthes Maintenance Spray (05.001.098) and oiling Adapter for Electric Pen Drive (05.001.101). 2. Push the spray in the attachment coupling of the hand- piece and briefly actuate it once (approx. 1 sec.). When doing so, wrap the pen with a cloth to catch excess oil, or hold it over a washbasin.
  • Page 44 Oiling movable parts of the handpiece with Synthes Maintenance Oil 05.001.095 Apply one drop of Synthes Maintenance Oil (05.001.095) in the slots between the adjustment sleeve (2) and the basic body, one drop of oil in the slots behind the release sleeve (3) and move the sleeves.

  • Page 45: Inspection, Packaging, Sterilization And Storage

    (adjustment sleeve and release sleeve of the pen as well as couplings of the attachments). Storage 3. Synthes recommends using a new sterile cutting tool for Storage conditions for products labeled “STERILE” are each surgery. printed on the packaging label. Packaged and sterilized...

  • Page 46: Repairs And Technical Service

    Care and Maintenance Repairs and Technical Service The tool should be sent to the Synthes office for repair if it is faulty or malfunctions. If a device drops, it has to be sent in for service. Faulty devices may not be used. If it is no longer possible or feasible to repair the device it should be disposed of, cf.

  • Page 47: Disposal

    Please send tools that are no longer used to the local Synthes representative. This ensures that they are disposed of in accordance with the national application of the respective directive.

  • Page 48: Troubleshooting

    Precaution: When removing objects, set unit to LOCK. Only high-speed attachments can be Do not use the drill, screw, saw or used with Pen 90K (05.001.011). Kirschner wire attachment with Pen 90K (05.001.011). DePuy Synthes Electric Pen Drive Instructions for Use...
  • Page 49 Problem Possible causes Remedy Tool (saw blade, drill, burr etc.), cannot Replace tool or send to your Synthes Shaft geometry of tool damaged. be coupled or only with difficulty. service office. Bones and tool heat up due to working Cutting edges of tool are blunt.
  • Page 50 60k pen is not switched to OFF position. Switch 60k pen to OFF position on adjustment sleeve. Software version. Check serial number with Synthes representative. If the recommended remedies are unsuccessful, please contact your Synthes service center. DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 51: System Specifications

    *Technical data is subject to tolerances. Specifications are approximate and may vary from one device to another or as a result of power supply fluctuations. Dimensions: 350 mm 210 mm 160 mm (bar included) Electric Pen Drive Instructions for Use DePuy Synthes...
  • Page 52 IEC 61000-6-1 / 61000-6-2 / 61000-6-3 / 61000-6-4 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. DePuy Synthes Electric Pen Drive Instructions for Use...
  • Page 53 1060 hPa 1060 hPa 1.06 bar 1.06 bar 1.06 bar 700 hPa 500 hPa 500 hPa 0.7 bar 0.5 bar 0.5 bar Altitude 0 – 3000 m 0 – 5000 m – Electric Pen Drive Instructions for Use DePuy Synthes...
  • Page 54 (05.001.099) is strongly recom- Drill/Burr Attachments 30 s 30 s 10 cycles mended. – The Electric Pen Drive must not be stored or operated in Craniotome Attachment 30 s 30 s 5 cycles an explosive atmosphere. Perforator...
  • Page 55 > 8 h 03.000.330 Burr Attachment Burr > 8 h 05.001.055 03.000.017 Burr > 8 h 03.000.108 EPD 05.001.011 – – – > 8 h Burr Attachment – – > 8 h 05.001.050 Electric Pen Drive Instructions for Use DePuy Synthes...
  • Page 56 5 h 1 min 03.000.330 Burr Attachment Burr 0.91 no limitation 05.001.055 03.000.017 Burr 0.71 no limitation 03.000.108 EPD 05.001.011 – – < 2.5 no limitation Burr Attachment – < 2.5 no limitation 05.001.050 DePuy Synthes Electric Pen Drive Instructions for Use...

  • Page 57: Electromagnetic Compatibility Accompanying Documents

    Guidelines and manufacturer’s declaration – electromagnetic emissions The Synthes EPD System is intended for use in the electromagnetic environment specified below. The customer or the user of the Synthes EPD System should assure that it is used in such an environment. Emission test Compliance Electromagnetic environment –...
  • Page 58 Guidelines and manufacturer’s declaration – electromagnetic immunity The Synthes EPD System is intended for use in the electromagnetic environment specified below. The customer or the user of the Synthes EPD System should assure that it is used in such an environment. Immunity test...
  • Page 59 TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Synthes EPD System is used exceeds the applicable RF compliance level above, the Synthes EPD System should be observed to verify normal operation.
  • Page 60 Synthes EPD System The Synthes EPD System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Synthes EPD System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Synthes EPD System as recommended below, according to the maximum output power of the communication equipment.

  • Page 61: Ordering Information

    Cable Electric Pen Drive – Console, length 4 m 05.001.040 Reciprocating Saw Attachment, for EPD and APD 05.001.022 Cable Foot Switch – Console, for Electric Pen Drive, length 4 m 05.001.042 Drill Attachment 45°, with Mini Quick Coupling, 05.001.108 Light Adapter, for Colibri for EPD and APD 05.001.025...
  • Page 62 310.932 Spare Key, for Nos. 310.930, 532.016 and 05.001.120 Cutting Tools For ordering informations for the Electric Pen Drive Cutting Tools refer to the brochure “Cutting Tools for Electric Pen Drive and Air Pen Drive” (036.000.054). DePuy Synthes Electric Pen Drive...
  • Page 64 Ö036.000.800öAGLä Synthes GmbH This publication is not intended for distribution in the USA. Eimattstrasse 3 CH-4436 Oberdorf All technique guides are available as PDF files at 0123 www.synthes.com www.synthes.com/lit...

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