Johnson & Johnson DePuy Synthes Electric Pen Drive User Manual
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Johnson & Johnson DePuy Synthes Electric Pen Drive User Manual

Compact drive with specific attachments for a wide spectrum of applications
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Electric Pen Drive
Compact Drive With Specific Attachments
For A Wide Spectrum Of Applications
User's Manual

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Summary of Contents for Johnson & Johnson DePuy Synthes Electric Pen Drive

  • Page 1 Electric Pen Drive Compact Drive With Specific Attachments For A Wide Spectrum Of Applications User‘s Manual...

  • Page 2: Table Of Contents

    Table of Contents Introduction General Information Explanation of Symbols Consoles Standard and Basic Consoles Set-up of Consoles Speed Regulation Irrigation Electric Pen Drive System Electric Pen Drive 60,000 rpm (05.001.010) Hand Switch (05.001.012) Foot Switch, 1 Pedal (05.001.016) Foot Switch, 2 Pedals (05.001.017) Attachments General Information Drill Attachments...
  • Page 3 Table of Contents Cutting Tools General Information Cleaning and Disinfection General Information Preparation Prior to Cleaning Manual Cleaning Instructions Automated Cleaning Instructions with Manual Pre-Cleaning Care and Maintenance Maintenance and Lubrication Function Control Packaging, Sterilization and Storage Repairs and Technical Service Disposal Troubleshooting System Specifications...

  • Page 4: General Information

    To ensure proper operation of the tool, use only DePuy with single-use instruments. Dispose of instruments used Synthes original accessories. or suspected of use on a patient with CJD after surgery and / or follow current national recommendations. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 5 Introduction such as cleaning brushes, DePuy Synthes Maintenance Precautions: Oil for EPD and APD (05.001.095), Maintenance Spray • To avoid injuries, the locking mechanism of the tool (05.001.098), and a Maintenance Unit (05.001.099). has to be activated before every manipulation and before placing the tool back down, i.e.

  • Page 6: Explanation Of Symbols

    Indicates Environment Friendly Use Period of 50 years in China Lot number Humidity limitation Serial number Packaging unit ISO 7000-2794 (2009-02) Atmospheric pressure limitation Use-by-date Do not use if package is damaged INMETRO Ord. 350 certified DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 7: Standard And Basic Consoles

    Consoles Standard and Basic Consoles The Electric Pen Drive (05.001.010) can be supplied with the Standard Console (05.001.006), or the Basic Console without irrigation (05.001.002). Standard Console with Irrigation, without Torque Limiting Function (05.001.006) 1. Slide control for adjusting the maximum speed for 1 Electric Pen Drive ( 2.

  • Page 8: 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: 2x3AF/250V, Breaking Capacity 1500A DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 9 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.

  • Page 10: Speed Regulation

    DePuy Synthes. Marking Console Setting Pen 60k 100% 100% This is also explained by symbols on the supplied adhesive foil. The adhesive foil can be applied to the console as a reference aid. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 11: Irrigation

    Consoles Irrigation Function of the Standard Console (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 tissue necrosis affected by excess heat. Irrigation nozzles for the attachments and sterile irrigation tubes are available for the irrigation system.
  • Page 12 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. Fig. 4 DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 13: 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 counterclockwise Lock slide for adjustment sleeve Turning the Adjustment Sleeve To avoid an unintentional change of the operating mode the lock slide for adjustment sleeve (7) locks the...

  • Page 14: Hand Switch (05.001.012)

    (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). DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 15: Foot Switch, 1 Pedal (05.001.016)

    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.

  • Page 16: Foot Switch, 2 Pedals (05.001.017)

    (FWD or REV), defined by the adjustment sleeve of the handpiece. • When the cable is not connected properly to the foot switch, it is possible that the handpiece is activated without pressing the foot switch. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 17: General Information

    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 Release sleeve 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.

  • Page 18: Drill Attachments

    Insert / remove the tool. Close the chuck by turning the moving parts counterclockwise and tighten it by turning the key clockwise. * The cannulation was implemented from batch number 9232779. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 19 Attachments Drill Attachment 90°, Short (05.001.035) and Long (05.001.036) with Mini Quick Coupling Speed: approx. 1,800 rpm 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 Lock unit.

  • Page 20: Screw Attachments

    (1). After the lever is released, the Kirschner Wire is automatically tensioned. To re-grasp, press the tensioning lever, pull back the unit along the Kirschner Wire and then release the tensioning lever again. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 21: Saw Attachments

    Attachments Saw Attachments Working with Saw Attachments Allow the unit to start up before placing it on the bone. Avoid heavy pressure on the saw blade so that the cutting process is not slowed and the saw teeth do not bind up in the bone.
  • Page 22 • Turn the release sleeve for saw blades (1) clockwise until it engages and remove the saw blade. • Insert a new saw blade until slight resistance can be felt. Turn the saw blade with slight pressure until it automatically engages. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 23: Burr Attachments

    Attachments Burr Attachments Burr Attachments (05.001.045–05.001.050, 05.001.055, 05.001.063) Gear ratio: 1:1. The system includes straight and angled Burr Attachments in 3 lengths each (S, M, L). The related burrs are also marked with S, M and L. Angled XL and XXL Burr Attachments are also available;...
  • Page 24 - Check the vibration and the stability of the used cutting tool before every usage on the patient. If vibration or instability occur, reduce the speed until the vibration stops or do not use the burr. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 25: Adapter For Intra Coupling

    Attachments Adapter for Intra Coupling Adapter for Intra Coupling (05.001.103) Gear ratio 1:1 The Adapter for Intra Coupling (05.001.103) enables the use of dental handpieces, mucotomes and dermatomes designed according to ISO 3964 (EN 23 964) in combination with the Electric Pen Drive (05.001.010) and Air Pen Drive (05.001.080).

  • Page 26: Perforators

    • Check function before each use of the perforator. • The user is liable for ensuring the compatibility of the Perforator with Hudson Coupling, the Irrigation Nozzle and the cutting tool used. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 27: Craniotome Attachment

    Attachments Craniotome Attachment Craniotome Attachment (05.001.059) Craniotome Attachment Dura Guard and Dura Guards (05.001.051–05.001.053) 05.001.059 05.001.051–05.001.053 Gear ratio: 1:1 The system includes a Craniotome Attachment and Dura Guards in 3 lengths (S, M, L). The related burrs are also marked with S, M and L. Cranial Burr 03.000.124S–03.000.126S Changing Cranial Burrs...

  • Page 28: General Information

    Note: For an overview and the ordering information opened, and assumes no liability in such instances. of all cutting tools available, refer to the brochure “Small Bone Cutting Tools”. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 29: General Information

    Cleaning and Disinfection General Information • DePuy Synthes recommends using new, sterile Power tools and attachments are frequently exposed to cutting tools for each operation. high mechanical loads and shocks during use and should not be expected to last indefinitely. Proper handling and •...

  • Page 30: Preparation Prior To Cleaning

    The foot switch may be cleaned under running water if * For details on mechanical/automated cleaning, please see Maintenance and Cleaning Chart for Pen Drive Systems. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 31: Manual Cleaning Instructions

    Cleaning and Disinfection Manual Cleaning Instructions Important: Do not clean consoles, foot switches and cable for the foot switches using the following Manual Cleaning Instructions. 1. Remove Debris: Rinse the device under running cold tap water for a minimum of 2 minutes. Use a sponge, soft, lint-free cloth or soft-bristled brush to assist in removing gross soil.
  • Page 32 2 minutes. 10. Dry: Dry device using a soft, lint-free cloth or medical grade compressed air. If smaller devices or cannulations contain residual water, blow dry with medical grade compressed air. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 33: Automated Cleaning Instructions With Manual Pre-Cleaning

    Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-Cleaning Important: • Manual pre-cleaning prior to automated cleaning/ disinfection is important to ensure that cannulations and other difficult to access areas are clean. • Alternative cleaning / disinfection procedures other than in the procedure described below (including manual precleaning) have not been validated by DePuy Synthes.
  • Page 34 Repeat steps 1–7 until no visible soil remains. 8. Load Washing Basket: Place devices into the specially designed tray for machine washing supplied by DePuy Synthes if available, or refer to the loading plan. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 35 Cleaning and Disinfection 9. Automated Cleaning Cycle Parameters Note: The washer / disinfector should fulfill the requirements as specified in ISO 15883. Step Duration Cleaning instructions (minimum) Rinse 2 minutes Cold tap water Pre-wash 1 minute Warm water (≥ 40 °C); use detergent Cleaning 2 minutes Warm water (≥...

  • Page 36: Maintenance And Lubrication

    Electric and Air Pen Drives is being applied after each use, or as needed. Apply the oil to the movable parts of the handpiece, as described in the following chapter entitled “Maintenance – Manual“. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 37 Care and Maintenance Maintenance – Manual Oiling the Handpiece – with Maintenance Spray 1. Perform maintenance on the handpiece following every use with the DePuy Synthes Maintenance Spray (05.001.098) and Oiling Adapter for Electric Pen Drives (05.001.101). 2. Push the spray in the attachment coupling of the handpiece and briefly actuate it once (approx.

  • Page 38: Function Control

    • Check the coupling sleeves of the handpiece and attachments for smooth operation and check for function together with instruments such as cutting tools. • Check instruments for correct adjustment and functioning prior to every use. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 39: Packaging, Sterilization And Storage

    Important: Remove the Seal Nipple for Cable (05.001.027) prior to sterilization. DePuy Synthes Electric Pen Drive System may be resterilized using validated steam sterilization methods (ISO 17665 or national standards). DePuy Synthes’ recommendations for packed devices and cases are as follows.

  • Page 40: Repairs And Technical Service

    Use only fuses of 3 AF / 250 V with a breaking capacity of 1500 A. Make sure that both fuses are of same type and rating. 3. Insert fuse drawer (15) into console. DePuy Synthes Electric Pen Drive User‘s Manual...

  • Page 41: Disposal

    Care and Maintenance Disposal In most cases faulty tools can be repaired (see previous chapter “Repairs and Technical Service”). The European directive 2012/19/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.
  • Page 42 Wait until Handpiece has cooled down. (overload protection is activated). Attachments cannot be Attachment Coupling is blocked by Remove solid objects with a pair of coupled to unit. deposits. tweezers. Precaution: When removing objects, set unit to LOCK. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 43 Troubleshooting Problem Possible causes Remedy Tool (saw blade, drill, burr Shaft geometry of tool damaged. Replace tool or send to your DePuy etc.), cannot be coupled or Synthes service center. only with difficulty. Bones and tool heat up due Cutting edges of tool are blunt. Replace tool.
  • Page 44 350 mm X 210 mm X 160 mm (bar included) * 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. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 45 System specifications The Device Meets the Following Standards Medical electrical equipment – Part 1: General requirements for basic safety and essential performance: IEC 60601-1 (2012) (Ed.3.1), E352266 EN 60601-1 (2006) +A11+A1+A12, Medical ANSI/AAMI ES60601-1:2005/(R)2012, General medical equipment as to electrical shock, fire and CAN/CSA-C22.2 NO.
  • Page 46 Transportation* Temperature Duration Humidity –29 °C; –20 °F 72 h uncontrolled 38 °C; 100 °F 72 h 85 % 60 °C; 140 °F 30 % *products have been tested according to ISTA 2A DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 47 System specifications Duty Cycles Precautions: • Carefully observe the recommended duty cycles. To prevent overheating, always respect the duty cycles • Always use new cutting tools to prevent heating up for each attachment listed below. of the system due to reduced cutting performance. •...
  • Page 48 Saw blade 12 h 05.001.182 03.000.315 05.001.183 Reciprocating Saw blade – no limitation Saw Attachment 03.000.321 05.001.040 Saw blade – no limitation 03.000.330 Burr Attachment Burr no limitation 05.001.055 03.000.017 Burr no limitation 03.000.108 DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 49 System specifications Declaration of Vibration Emissions According to EU Directive 2002/44/EC Vibration emissions [m/s ] according to EN ISO 5349-1 Handpiece Attachment Cutting tool Declaration Max. Daily Exposure [m/s EPD 05.001.010 – – < 2.5 Drill Attachment – < 2.5 AO/ASIF 05.001.032 Oscillating...

  • Page 50: Accompanying Documents According

    Voltage fluctuations/ Complies radio-frequency communication services. flicker emissions The user might need to take mitigation IEC 61000-3-3 measures, such as relocating or reorienting the equipment. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 51 Electromagnetic Compatibility Immunity (all devices) Guidance and Manufacturer‘s Declaration - Electromagnetic Immunity The DePuy Synthes EPD System is intended for use in the electromagnetic environment specified below. The customer or the user of the DePuy Synthes EPD System should ensure that it is used in such an environment. Immunity test standard IEC 60601 test Compliance level...
  • Page 52 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. c Possible shorter distances outside ISM bands are not considered to have a better applicability of this table. DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 53 Electromagnetic Compatibility Recommended Separation Distances Recommended Separation Distances Between Portable and Mobile RF Communications Equipment The DePuy 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 DePuy Synthes EPD System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the DePuy Synthes EPD System as recommended below, according to the maximum output power of the communication equipment.
  • Page 54 690.581 Lid, for Graphic Case 690.582 Attachment Rack, for Graphic Case 690.585 Graphic Case Base 690.587 Insert Tray for 60,000 rpm Drive Unit 690.588 Attachment Tray Assembly 690.589 Lid for Modular Graphic Case DePuy Synthes Electric Pen Drive User‘s Manual...
  • Page 55 Ordering Information Burr Attachments Accessories 05.001.045 Burr Attachment, S, for EPD and APD 05.001.121 Guide for Kirschner Wire, for Oscillating Saw, for EPD and APD 05.001.046 Burr Attachment, M, for EPD and APD 05.001.066 Irrigation Nozzle, short, for EPD and APD, for Nos.
  • Page 56 Please see the package insert(s) or other product labeling associated with the devices contained in this manual for additional information. Some devices in this manual may not have been licensed in accordance with Canadian law and may not be for sale in Canada. Please contact your sales consultants for items approved for sale in Canada.

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