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Johnson & Johnson DePuy Synthes Air Pen Drive Instructions For Use Manual

Compact drive with specific attachments for a wide spectrum of applications
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Compact drive with specific attachments for a wide spectrum of applications
Air Pen Drive
Instructions for Use

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

  • Page 1 Compact drive with specific attachments for a wide spectrum of applications Air Pen Drive Instructions for Use...

  • Page 3: Table Of Contents

    Table of Contents Introduction General Information Explanation of Symbols Air Pen Drive System Air Pen Drive Angular Coupling (05.001.085) Hand Switch (05.001.082) Foot Switch (05.001.081) Attachments General Information Drill Attachments Screw Attachments Kirschner Wire Attachment Saw Attachments Burr Attachments Adapter for Intra Coupling Perforators Craniotome Attachment Cutting Tools...
  • Page 4 Table of Contents Care and Maintenance General Information Cleaning and Disinfection • Preparation Prior to Reprocessing • Manual Cleaning Instructions • Automated Cleaning Instructions with Manual Pre-cleaning Maintenance and Lubrication Function Control Packaging, Sterilization and Storage Repairs and Technical Service Disposal Troubleshooting System Specifications...

  • Page 5: General Information

    Introduction General Information Intended use Always wear personal protective equipment (PPE) The Air Pen Drive is an air-driven system to be used for including safety goggles when handling with the Air treatment in general traumatology, as well as for surger- Pen Drive.
  • Page 6 Introduction General Information Precautions: For care and maintenance special tools are available, Never use oxygen to run air-powered systems such as cleaning brushes, Synthes Maintenance Oil • (danger of explosion!); only use compressed air or for EPD and APD (05.001.095), Maintenance Spray compressed nitrogen.

  • Page 7: Explanation Of Symbols

    Introduction Explanation of Symbols Caution Do not reuse Products intended for single use must not be Read the provided instructions for use before reused. operating the device. Reuse or reprocessing (e.g. cleaning and resterilization) may compromise the §struc- Do not immerse device in liquids. tural integrity of the device and/or lead to de- vice failure, which may result in patient injury, The device meets the requirements of direc-...

  • Page 8: Air Pen Drive

    Air Pen Drive System Air Pen Drive Mounting the air hose on the handpiece The Air Hose (05.001.083 or 05.001.084) is coupled by fitting the pins on the hose coupling into the grooves on the coupling for hoses on the handpiece and turning the hose coupling clockwise.
  • Page 9 Adjustment sleeve To avoid an unintentional change of the operating mode the lock slide for adjustment sleeve 7 locks the adjust- ment sleeve automatically. To be able to move the adjustment sleeve the lock slide has to be pushed back- wards. After having reached the desired position release the lock slide and the adjustment sleeve is locked in the desired position.

  • Page 10: Angular Coupling (05.001.085)

    Air Pen Drive System Angular Coupling (05.001.085) The Angular Coupling (05.001.085) can be connected to the Air Pen Drive (05.001.080) and the Air Hose (05.001.083 or 05.001.084) and is used to guide the air hose away from the handpiece in a 45° angle. It allows 360°...

  • Page 11: Hand Switch (05.001.082)

    Air Pen Drive System Hand Switch (05.001.082) Positioning arrow Pull-out finger rest Positioning arrow Guide groove Locking switch Mounting the Hand Switch on the Handpiece Position the Hand Switch on the handpiece so that both positioning arrows 1 of the Hand Switch cover the posi- tioning arrows 3 over the guide grooves 4 of the pen.

  • Page 12: Foot Switch (05.001.081)

    Air Pen Drive System Foot Switch (05.001.081) Pedal Irrigation ON/OFF button* Plug for Double Air Hose Plug for Irrigation Control Unit* Plug for Air Pen Drive Hose Connecting the Foot Switch Connect a Double Air Hose (519.510, 519.530, 519.550 for System Synthes; 519.610, 519.630, 519.650 for System Dräger;...

  • Page 13: General Information

    Attachments General Information Mounting the attachments on the handpiece The attachments can be connected in 8 different posi- tions (45° increments). To mount, turn the release sleeve for the attachments clockwise (see arrow on the release Release sleeve sleeve) until it engages. The release sleeve protrudes slightly from the black section of the handpiece towards the front.

  • Page 14: Drill Attachments

    Attachments Drill Attachments Drill Attachments (05.001.030–05.001.032, 05.001.044) Speed: approx. 1,800 rpm at 6.5 bar The system includes straight Drill Attachments with Mini Quick, J-Latch and AO/ASIF Coupling and a 45° cannu- lated AO/ASIF Drill Attachment. The 45° Drill Attachment with AO/ASIF Coupling (05.001.044) has a cannulation of 1.6 mm, which per- mits the use of this attachment for drilling and reaming over Kirschner Wire (e.g.
  • Page 15 Drill Attachment 90°, short (05.001.035) and long (05.001.036) with Mini Quick Coupling Speed: approx. 1,800 rpm at 6.5 bar Due to its very small angled head, the 90° Drill Attach- ments enable good visibility during operations with narrow access (e.g. intraoral, shoulder etc.). Mounting and removing tools Lock unit.

  • Page 16: Screw Attachments

    Attachments Screw Attachments Screw Attachments (05.001.028, 05.001.029, 05.001.034) Speed: approx. 400 rpm at 6.5 bar 1 Release sleeve The system includes screw attachments with AO/ASIF coupling, hexagonal and mini quick coupling. Mounting and removing tools Lock unit. Pull back the release sleeve and insert/remove the tool.

  • Page 17: Kirschner Wire Attachment

    Attachments Kirschner Wire Attachment Kirschner Wire Attachment (05.001.037) Speed: approx. 2,700 rpm at 6.5 bar With the Kirschner Wire Attachment, Kirschner Wires of any length with a diameter of 0.6–1.6 mm can be ten- sioned. The tensioning lever 1 can be rotated by 300°, permitting individual adjustment (suitable for left and right-handed users).

  • Page 18: Saw Attachments

    Attachments Saw Attachments Working with saw attachments Information on handling saw blades Allow the unit to start up before placing it on the bone. Synthes recommends using a new saw blade for each Avoid heavy pressure on the saw blade so that the cut- surgery, as only then can it be ensured that the saw ting process is not slowed and the saw teeth do not bind blade is always optimally sharpened and clean.
  • Page 19 Oscillating Saw Attachment (05.001.038) Frequency: 16,000 osc./min at 6.5 bar The Oscillating Saw Attachment is used with Synthes crescentic and 105° angled saw blades. 1 Release sleeve for saw blades 2 Mounting opening for saw blades Changing saw blades 1. Lock unit. 2.

  • Page 20: 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 Attach- ments 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 available;...
  • Page 21 Drill/Burr Attachment, Straight, for Round Shafts B 2.35 mm (05.001.123) Gear ratio 1:1 Drill/Burr Attachment, Straight, for Round Shafts B 2.35 mm (05.001.128) Gear ratio 16:1 Friction fit attachment for 2.35 mm diameter shafts with round shaft, J-latch and Mini-quick coupling. Changing cutting tools 1.

  • Page 22: 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 combina- tion with the Electric Pen Drive (05.001.010) and Air Pen Drive (05.001.080).

  • Page 23: Perforators

    Attachments Perforators Perforator (05.001.054) Gear reduction: 97:1 The perforator is used with the related trepan burrs (03.000.350–03.000.351) including the protective sleeves (05.001.096–03.001.097) to open a cranium with a thickness of 3 mm or above. The handpiece has to be in the FWD position.
  • Page 24 Attachments Perforators Perforator with Hudson Coupling (05.001.177) Gear reduction: 97:1 The Perforator with Hudson coupling is used with a tre- pan burr/protection sleeve combination – usually referred 1 Coupling sleeve to as a cranial perforator – with a Hudson end to open the cranium.

  • Page 25: Craniotome Attachment

    Attachments Craniotome Attachment Craniotome Attachment (05.001.059) and Dura Guards (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. Craniotome Attachment Cranial Burr Dura Guard 05.001.059...

  • Page 26: General Information

    Cutting Tools General Information Intended use Saw blades Packaging and Sterility The saw blades are designed for use in traumatology All cutting tools are available sterile packed. and orthopaedic surgery of the skeleton, e.g. cutting bone. The manufacturer cannot guarantee sterility if the pack- age seal is broken or if the package is improperly Stainless steel burrs opened, and assumes no liability in such instances.
  • Page 27 Care and Maintenance General Information pressurized water as this will cause damage to the Power tools and attachments are frequently exposed to high mechanical loads and shocks during use and should system. Synthes recommends using new sterile cutting not be expected to last indefinitely. Proper handling and •...
  • Page 28 Care and Maintenance Cleaning and Disinfection Preparation Prior to Reprocessing Disassembly Before cleaning, remove all the instruments, cutting tools, attachments and cables from the power tool. Fig. 1: Pen with Protective Cap Important: Clean all movable parts in opened or unlocked •...
  • Page 29 Care and Maintenance Cleaning and Disinfection Manual Cleaning Instructions Important: Follow the instructions from chapter ”Preparation • Prior To Cleaning” before starting the manual cleaning. Do not clean the foot switch following the Manual • Cleaning Instructions. 1. Remove debris. Rinse the device under running cold tap water for a minimum of 2 minutes.
  • Page 30 Care and Maintenance Cleaning and Disinfection Manual Cleaning Instructions Follow the enzymatic cleaner or detergent manufac- turer’s instructions for use for correct temperature, water quality and concentration/dilution. 6. Rinse with tap water. Rinse the device thoroughly using cool to lukewarm running water for a mini- mum of 2 minutes.
  • Page 31 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-cleaning Important: Follow the instructions from chapter ”Preparation • Prior To Cleaning” before starting the automated cleaning with manual pre-cleaning. Manual pre-cleaning prior to automated cleaning/ • disinfection is important to ensure that cannula- tions and other difficult to access areas are clean.
  • Page 32 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-cleaning 4. Rinse with tap water. Rinse device with cold tap water for a minimum of 2 minutes. Use a syringe or pipette to flush lumens and channels. 5. Clean with detergent. Clean the device manually under running warm water using an enzymatic cleaner or detergent for a minimum of 5 minutes.
  • Page 33 Loading Plan for Air Pen Drive (APD) Washing Basket 68.001.800 Washing Basket, size ∕ , for Electric Pen Drive (EPD) and Air Pen Drive (APD) 1 68.001.602 Lid for Washing Basket, size ∕ 05.001.086 Protective Cap: Connect and protect the APD Handpiece with the Protective Cap during washing.
  • Page 34 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-cleaning 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 (≥...
  • Page 35 Care and Maintenance Maintenance and Lubrication To ensure long service life and reduce repairs, it is nec essary that the accessible moving parts of the hand- piece and attachment are lubricated after each use. Lubrication helps prevent damage and malfunction of the devices.
  • Page 36 Care and Maintenance Maintenance and Lubrication Maintenance – manually Oiling the handpiece – with Maintenance Spray 05.001.098 1. Perform maintenance on the handpiece following every use with the Synthes Maintenance Spray (05.001.098) and Oiling Adapter for Air Pen Drive (05.001.092). The pen must be on foot switch position.
  • Page 37 Maintenance of movable parts on handpiece and Foot Switch – with Synthes Maintenance Oil (05.001.095) Apply Synthes Maintenance Oil 05.001.095 for Electric and Air Pen Drive after each use or when needed, on movable parts on the handpiece and the Foot Switch. Oiling movable parts of the handpiece Apply one drop of oil in the slots between the adjust- ment sleeve 1 and the basic body, one drop of oil in the...
  • Page 38 Care and Maintenance Function Control • Visually inspect for damage and wear. • Should the system have corroded parts, do not use it anymore and send it to the Synthes service center. • Check the handpiece controls for smooth operation and function.
  • Page 39 Care and Maintenance Packaging, Sterilization and Storage Packaging Storage Put cleaned, dry products into the proper places in the Storage conditions for products labeled ”STERILE” are Synthes Vario Case (68.000.020 or 68.000.030) or in the printed on the packaging label. Packaged and sterilized Washing Basket (68.001.800).
  • Page 40 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 tool it should be disposed of, cf.
  • Page 41 Care and Maintenance Disposal In most cases, faulty tools can be repaired (cf. previous chapter ”Repairs and Technical Service”). Precaution: Contaminated products have to run through the complete reprocessing procedure, so that there is no danger of infection in case of disposal.
  • Page 42 Troubleshooting Problem Possible causes Remedy Pen does not start up. Adjustment sleeve on pen is set to Set adjustment sleeve to HAND or LOCK position. FOOT switch position. Release sleeve for burr on burr Set release sleeve on burr attachment attachment set to UNLOCK position.
  • Page 43 Problem Possible causes Remedy Pen runs at full speed all the time. Adjustment sleeve is in the position Set adjustment sleeve in position FOOT without having a foot switch HAND or LOCK. attached. Attachments cannot be coupled Attachment coupling is blocked Remove solid objects with a pair to unit.
  • Page 44 System Specifications Technical Data Weight: 169 g/5.96 oz Length: 144 mm/5.7 in Recommended 6–8 bar Pressure: For maximum 10 minutes (continuous operation) it is possible to run the Air Pen Drive up to 12 bar* with the following attachments: 05.001.045– 05.001.050, 05.001.054, 05.001.059, 05.001.055.
  • Page 45 Environmental Conditions Operation Storage Temperature 40 °C 40 °C 104 °F 104 °F 10 °C 10 °C 50 °F 50 °F Relative humidity Atmospheric pressure 1060 hPa 1060 hPa 1.06 bar 1.06 bar 700 hPa 700 hPa 0.7 bar 0.7 bar Altitude 0–3000 m 0–3000 m...
  • Page 46 System Specifications Duty cycles These recommendations for times of use for the attach- To prevent overheating, always respect the duty cycles ments for Air Pen Drive have been determined under for each attachment listed below. average load with an ambient air temperature of 20 °C (68 °F).
  • Page 47 Declaration of the emission sound pressure level and the sound power level according to the EG guideline 2006/42/EG Annex I Sound pressure level [LpA] in accordance with the norm EN ISO 11202 Sound power level [LwA] in accordance with the norm EN ISO 3746 Handpiece Attachment Cutting tool...
  • Page 48 System Specifications Declaration of vibration emissions according to EU Directive 2002/44/EC Vibration emissions [m/s2] according to EN ISO 5349-1. Handpiece Attachment Cutting tool Declaration Max. daily [m/s exposure APD 05.001.080 – – < 2.5 Drill Attachment – < 2.5 AO/ASIF 05.001.032 Oscillating Saw blade...
  • Page 49 Ordering Information Handpiece 05.001.080 Air Pen Drive 60.000 rpm Foot Switch 05.001.081 Foot Switch, for Air Pen Drive Hand Switch 05.001.082 Hand Switch, for Air Pen Drive Hoses and Accessories 05.001.083 Double Air Hose, length 3 m, for Air Pen Drive 05.001.084 Double Air Hose, length 5 m, for Air Pen Drive 05.001.085...
  • Page 50 Ordering Information 05.001.103 Adapter for Intra Coupling, for EPD and APD 05.001.076 Irrigation Nozzle, for Perforator No. 05.001.054 05.001.180 Irrigation Nozzle, for Perforator with Hudson Coupling 05.001.177 Drill/Burr Attachments 05.001.178.01S Irrigation Tube Set, for EPD and APD, sterile, single pack 005.001.123 Drill/Burr Attachment, straight, for Round Shafts B 2.35 mm, for EPD and APD...
  • Page 52 Not all products are currently available in all markets. Please contact your Depuy Synthes sales representative for more information. Synthes GmbH Eimattstrasse 3 4436 Oberdorf All Synthes implant instructions for use as well as additional Switzerland instructions for use are available as PDF files at www.e-ifu.com Tel: +41 61 965 61 11 0123 www.jnjmedicaldevices.com...

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