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Johnson & Johnson DePuy Synthes Small Battery Drive II User Manual

Battery driven power tool system for small bone and sports medicine surgeries
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Battery Driven Power Tool System for Small Bone and Sports Medicine Surgeries
Small Battery Drive II
User Manual

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Summary of Contents for Johnson & Johnson DePuy Synthes Small Battery Drive II

  • Page 1 Battery Driven Power Tool System for Small Bone and Sports Medicine Surgeries Small Battery Drive II User Manual...

  • Page 3: Table Of Contents

    Table of Contents Introduction General Information Small Battery Drive II Handpiece Attachments General Information Drill Attachments Screw Attachments Ream Attachments Other Rotating Attachments Saw Attachments Care and Maintenance General Information Cleaning and Disinfection • Preparation Prior to Reprocessing • Manual Cleaning Instructions •...
  • Page 4 Table of Contents System Specifications Electromagnetic Compatibility Ordering Information DePuy Synthes User Manual Small Battery Drive II...

  • Page 5: Introduction

    Introduction General Information Intended use The Small Battery Drive II is designed for the use in Expected Clinical Benefits traumatology and orthopedic surgery of the skeleton, i.e. Power Tools systems offer the following benefits to the drilling, reaming or cutting bone. patient and health care professionals compared to a manual approach: Intended user...
  • Page 6 Introduction General Information Unusual Transmissible Pathogens defined in the “Care and Maintenance” section. Warning: Surgical patients identified as at risk for Compliance with these specifications can considerably Creutzfeldt-Jakob disease (CJD) and related infections extend the service life of the tool and reduce the risk of should be treated with single-use instruments.
  • Page 7 original manufacturer or an authorized site. The Synthes Universal Battery Charger II (05.001.204). Special auxiliaries such as cleaning brushes and Depuy manufacturer assumes no responsibility for damage Synthes oil are available for cleaning and servicing the resulting from improper operation, neglected or system.
  • Page 8 Introduction General Information Explanation of the general symbols used Do not reuse The following symbols are applied to the device or Products intended for single use must not be individual components. Information on additional reused. symbols is given in the relevant sections of this document.
  • Page 9 Legal Manufacturer Manufacturing date Non sterile Non sterile Sterilized using radiation Do not use if package is damaged. Reference number Lot number Serial number Expiration date Packaging unit ISO 7000-2794 (2009-02) Medical Device in the European Community/Union INMETRO Ord. 350 certified Small Battery Drive II User Manual DePuy Synthes...

  • Page 10: Handpiece

    Small Battery Drive II Handpiece 1 Attachment coupling 2 Trigger for speed regulation 3 Trigger for switching to reverse / oscillating drilling 4 Mode selector switch OFF (lock), Oscillating Mode (forward/oscillating), ON (forward, reverse) 5 Battery pack (battery casing with inserted battery) 6 Release buttons for attachment 7 Release buttons for battery casing 8 Knob for the battery casing cover...
  • Page 11 Mode selector switch in the oscillating drilling Warnings: position ( • Using the Small Battery Drive II outside the When the bottom and top triggers 2 and 3 are pressed specified electromagnetic environment may lead to at the same time, the tool immediately switches to malfunction (e.g.

  • Page 12: Use

    Small Battery Drive II Before initial use, brand-new tools and accessories must undergo the entire reprocessing process. Completely remove protective caps and films. To ensure the longest possible service life, the manufacturer has partially charged the battery for transport and storage purposes.
  • Page 13 3. The circulating person carefully guides the unsterile battery through the sterile cover (Fig. 5). As an orientation guide, the two symbols of the battery and the sterile cover should face each other (Fig. 6). The same person presses it completely into the battery casing to ensure a correct seat (Fig.

  • Page 14: Small Battery Drive Ii

    Small Battery Drive II Warnings: • Do not open a battery casing intraoperatively to insert a new battery. Always replace the whole battery pack by another battery pack which should have been prepared before the start of the surgery. • To close the casing cover, press it firmly to ensure that it is completely closed (Fig.
  • Page 15 Charging, storing and using of Small Battery Drive II batteries (532.103) Warnings: • Do not dismantle, open, short-circuit or shred Charging batteries. Warning: Only use the Depuy Synthes Universal • In case of cell leakage, do not allow the leaking Battery Charger II (05.001.204) to charge the battery.
  • Page 16 Small Battery Drive II Oscillating drilling ( ) mode To protect soft tissue when drilling and inserting Kirschner wires, the Small Battery Drive II has an electronically controlled oscillating mode. To preset the oscillating mode, switch the mode selector switch to position.

  • Page 17: General Information

    Attachments General Information The Small Battery Drive II system offers a broad range of attachments. A wide range of rotating attachments has color-coded rings, so that they can easily be identified. The table on the next page lists the different types of attachments available, the color coding as well as the speed of each attachment.
  • Page 18 Attachments General Information Article Product Speed Color coding Number for speed Drill 05.001.250 AO/ASIF Quick Coupling 1290 rpm Blue Attachments 05.001.252 Chuck (Drilling Speed), with Key, clamping range up 1290 rpm Blue to B 4.0 mm 05.001.253 Chuck (Drilling Speed), with Key, clamping range up to 1290 rpm Blue B 7.3 mm...

  • Page 19: Drill Attachments

    Attachments Drill Attachments AO/ASIF Quick Coupling (05.001.250) For tools with an AO/ASIF coupling shaft. Mounting and removing the tools Insert the tool into the attachment from the front applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment.

  • Page 20: Screw Attachments

    Attachments Screw Attachments Screw Attachment, with AO/ASIF Quick Coupling (05.001.251) Mounting and removing the tools Insert the tool into the attachment from the front by applying slight pressure and turning slightly. It is not necessary to operate the coupling sleeve of the attachment.

  • Page 21: Ream Attachments

    Attachments Ream Attachments All Small Battery Drive II Ream Attachments provide an approximative maximal torque of 7.5 Nm (with battery 532.103). Quick Couplings for Medullary Reaming AO/ASIF Quick Coupling (532.017) Hudson Quick Coupling (532.018) Trinkle Quick Coupling (532.019) Trinkle Quick Coupling, modified (532.020) The Quick Couplings for Medullary Reaming enable the use of flexible shafts with the appropriate coupling geometry.
  • Page 22 Attachments Ream Attachments Chucks There are two chucks available as Ream Attachments for the Small Battery Drive II system. Article number Clamping range Spare key Comments 05.001.254 0.5–7.3 mm 510.191 For drilling and medullary reaming, with reverse motion Inserting cutting tools Open the jaws of the chuck using the appropriate key or by hand.

  • Page 23: Other Rotating Attachments

    Attachments Other Rotating Attachments Mini Quick Coupling (532.011) J-Latch Coupling (532.012) For tools with a Mini Quick or J-Latch coupling shaft. Mounting and removing the tools To connect the tool, pull the coupling sleeve back and then introduce the tool while rotating slightly. To disconnect, push the coupling sleeve of the attachment back and remove the tool.
  • Page 24 Attachments Other Rotating Attachments Radiolucent Drive (511.30) The Radiolucent Drive can be used with the Small Battery Drive II in combination with the AO/ASIF Quick Coupling (05.001.250) and the Adapter for the Radiolucent Drive (532.031). Coupling the Radiolucent Drive to the power tool Connect the AO/ASIF Quick Coupling to the Small Battery Drive II and the adapter to the Quick Coupling.
  • Page 25 Using the Radiolucent Drive Before positioning the Radiolucent Drive, align the image intensifier until the distal locking hole of the medullary nail is round and easily visible. After the incision, position the Radiolucent Drive and center the drill bit tip over the locking hole. On the monitor of the image intensifier, you can see both the drill bit and the target rings of the drive.
  • Page 26 Attachments Other Rotating Attachments Warnings: • Grip the coupled Radiolucent Drive tightly when switching on the power tool, particularly if the power tool is held face down. • Only special 3-flute spiral drill bits can be used. Your Depuy Synthes representative will provide you with additional information on which drill bits can be used.
  • Page 27 Burr Attachment (05.001.187) The Burr Attachment is size M. It can be used with Burrs for Burr Attachments of the Electric Pen Drive and Air Pen Drive systems. It is compatible with burr types M and L, but it is recommended to use burrs of size M. Changing burrs 1.

  • Page 28: Saw Attachments

    Attachments Saw Attachments Oscillating Saw Attachment (532.021) Positioning the saw attachment The attachment can be locked in eight different positions (45° steps) when coupled: Lock the machine, shove the sliding sleeve N toward the saw blade coupling and rotate the attachment into the desired position (Fig.
  • Page 29 Positioning the saw blade The saw blade can be adjusted in the desired position vertically and horizontally at an angle of 45º (see the earlier sections “Positioning the saw attachment” and “Changing the saw blade”). Using the oscillating saw attachment The saw blade must already be oscillating when the saw is applied to the bone.
  • Page 30 Attachments Saw Attachments Oscillating Saw Attachment II (Crescentic Technique) (532.023) The Oscillating Saw Attachment II is essentially designed for use with semicircular saw blades (for example 03.000.313S) guided by a 1.6 mm Kirschner Wire. It can also be used with saw blades with a shaft extension (for example 03.000.340S) for reaching difficult-to-access sites (such as intraoral).
  • Page 31 Large Oscillating Saw Attachment (532.026) The Large Oscillating Saw Attachment is a specially designed saw attachment for performing a crescentic saw cut, e.g. while performing a Tibial Plateau Leveling Osteotomy in the canine proximal tibia. The attachment is approved for use in both humans and animals. Inserting the saw blade Insert the saw blade in the saw blade coupling and tighten the screw in the saw blade with the key...

  • Page 32: General Information

    Care and Maintenance General Information Power tool units and attachments are frequently exposed sheet. Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive to high mechanical loads and shocks during use and cleaners or wire brushes.

  • Page 33: Cleaning And Disinfection

    Care and Maintenance Cleaning and Disinfection Preparation Prior to Reprocessing Disassembly Disassemble device if applicable. Remove all instruments and attachments from the power tool. Remove the battery casing from the handpiece and then remove the battery itself. Cleaning and Disinfection of Batteries and Charger 1.

  • Page 34: Manual Cleaning Instructions

    Care and Maintenance Cleaning and Disinfection Manual Cleaning Instructions Warning: The Small Battery Drive II batteries must not be cleaned following the Manual Cleaning Instructions. 1. Remove debris. Rinse the device under running old tap water for a minimum of 2 minutes. Use a soft lint-free cloth or soft-bristled brush to assist in removing gross soil.
  • Page 35 3. Spray and wipe. Spray the device using a recommended dose of the detergent or neutral pH enzymatic cleaner (e.g. Steris Prolystica 2X Concentrate Enzymatic Cleaner 1/8 oz. per gallon). Leave the solution to interact with the surface of the device for a minimum of 2 minutes and then wipe it off (Fig.
  • Page 36 Care and Maintenance Cleaning and Disinfection Manual Cleaning Instructions 9. Final rinse with de-ionized / purified water. Final rinse with de-ionized or purified water for a minimum of 2 minutes. 10. Dry. Dry device using a soft lint-free cloth or medical grade compressed air.

  • Page 37: Automated Cleaning Instructions

    Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-Cleaning Warnings: The Small Battery Drive II batteries must not be cleaned following the Mechanical / 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.
  • Page 38 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-Cleaning 1. 3. Spray and wipe. Spray the device using a recommended dose of the detergent or neutral pH enzymatic cleaner (e.g. Steris Prolystica 2X Concentrate Enzymatic Cleaner 1/8 oz. per gallon). Leave the solution to interact with the surface of the device for a minimum of 2 minutes and then wipe it off (Fig.
  • Page 39 8. Load washing basket. Please use the specially designed tray for machine washing as supplied by Depuy Synthes (68.001.610). Follow the loading plan as shown below or refer to the loading plan. Ensure that the attachments are positioned in an upright position as shown and fully opened.
  • Page 40 Care and Maintenance Cleaning and Disinfection Automated Cleaning Instructions with Manual Pre-Cleaning 9. Automated cleaning cycle parameters Note: Automated washing shall be conducted in a validated washer-disinfector in compliance to ISO 15883-1 and-2, or to an equivalent standard. Load the device components in the washer-disinfector in accordance with manufacturer's instructions, ensuring that the devices and lumens can drain freely.

  • Page 41: Maintenance And Lubrication

    Care and Maintenance Maintenance and Lubrication The power tool and attachments should be regularly lubricated to ensure a long service life and smooth operation. It is recommended that the accessible moving parts of the handpiece, the battery casing and attachments are lubricated with 1 drop of Depuy Synthes special oil (519.970);...
  • Page 42 Care and Maintenance Maintenance and Lubrication Lubricating the battery casing (Fig. 3 and 4) • Place oil on the seal of the cover and then evenly distribute the oil on the seal. • Lubricate the lock, hinge and knob, then actuate it several times.
  • Page 43 Attachments All moving parts of all the attachments. Exception: the Radiolucent Drive (511.30) does not require lubrication. Chuck (05.001.252–05.001.254) Lubricate the jaws and toothed rim. Open and close the drill chuck several times. Quick Coupling for Kirschner Wires (532.022) Lubricate the tension lever and clamping mechanism. Hold the Quick Coupling up and add one drop of oil into the attachment hole and on the holder of the lever (Fig.
  • Page 44 Care and Maintenance Maintenance and Lubrication Warnings: • To ensure a long service life and reduce repairs, the power tool and all attachments must be lubricated after each use. Exception: The Radiolucent Drive (511.30) does not require lubrication. • The power tools and attachments must only be lubricated with Depuy Synthes Special Oil (519.97).

  • Page 45: Function Control

    Care and Maintenance Function Control • Visually inspect for damage and wear (e.g. unrecognizable markings, missing or removed part numbers, corrosion, etc.). • Check the handpiece controls for smooth operation and function. • All movable parts should be moving smoothly. Check that the triggers do not remain blocked in the handpiece when pressing on them.

  • Page 46: Packaging, Sterilization And Storage

    Depuy Synthes recommends the use of the specifically designed Washing Basket (68.001.610). or the Graphic Cases (06.550.060, 06.550.200 and 06.550.210) Depuy Synthes Small Battery Drive II system must be resterilized using validated steam sterilization methods (ISO 17665 or national standards). Depuy Synthes’...
  • Page 47 Storage Storage conditions for products labeled “STERILE” are printed on the packaging label. Packaged and sterilized products should be stored in a dry, clean environment, protected from direct sunlight, pests and extremes of temperature and humidity. Use products in the order in which they are received (“first-in, first-out principle“), taking note of any expiration date on the label.

  • Page 48: Repairs And Technical Service

    Care and Maintenance Repairs and Technical Service The tool should be sent to the DePuy Depuy Synthes office for repair if it is faulty or malfunctions. Warning: Contaminated products have to run through the complete reprocessing procedure before being sent to the Depuy Synthes office for repair or technical service.

  • Page 49: Disposal

    Care and Maintenance Disposal In most cases, faulty tools can be repaired (refer to the previous section “Repairs and Technical Service”). This device contains Lithium-Ion batteries that should be disposed of in an environmentally friendly manner. The European Battery Directive Li-Ion 2006/66/EC applies to this device.
  • Page 50 Troubleshooting Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. Problem Possible causes Solution Handpiece does not start up. Battery is dead.
  • Page 51 Problem Possible causes Solution The Kirschner wire is inserted The Kirschner wire was inserted from Lock the machine by turning the mode in the handpiece and cannot the rear. selector switch to OFF. Remove the be moved forward. attachment, hold the drive shaft opening down and shake out the Kirschner wire.
  • Page 52 System Specifications Applicable Standards The device meets the following standards Medical electrical equipment – Part 1: General requirements for basic safety and essential performance: 10PB E352266 IEC 60601-1 (2012) (Ed. 3.1), Medical General medical equipment as to electrical shock, EN 60601-1 (2006) + A11 + A1 + A12, fire and mechanical hazards only in accordance with: ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012) ANSI/AAMI ES60601-1:2005/(R)2012,...
  • Page 53 Environmental Conditions Operation Storage Temperature 40 °C 40 °C 104 °F 104 °F 10 °C 10 °C 50 °F 50 °F Relative humidity 90 % 90 % 30 % 30 % Atmospheric pressure 1060 hPa 1060 hPa 1.06 bar 1.06 bar 500 hPa 500 hPa 0.5 bar...
  • Page 54 System Specifications Technical Data Depuy Synthes has established the performance and safety of Small Battery Drive II and that it represents a state of the art medical surgical power tool and performs as intended for the function according to their instructions for use and labeling. Small Battery Drive II: 532.110 Battery: 532.103 Battery Casing: 532.132 Continuously adjustable speed:...
  • Page 55 Duty Cycles: Intermittent Precautions: operation type S9, • Generally, medical power tools will heat up if in according to IEC 60034-1 constant use. The cool down times should be observed, see “Duty Cycle” section, in order to Cycles s on s off prevent the power tool from exceeding its acceptable surface temperature.
  • Page 56 System Specifications Declaration of the emission sound pressure level and the power level according to the EU Directive 2006/42/EC Annex I Measurements of the sound pressure level [LpA] are carried out in accordance with standard EN ISO 11202. Measurements of the sound power level [LwA] are carried out in accordance with standard EN ISO 3746. Information according to test protocol no.: 1711-5323 / 03.10, date of testing: 17 February 2011.
  • Page 57 Declaration of vibration emission according to the EU Directive 2006/42/EC Annex I The assessment of the vibration emissions [m/s ] is to be made to the hand-arm system according to EN ISO 5349-1. Information according to test protocol no.: 1711-5323/03.10, date of testing: 18 February 2011. Handpiece Attachment Tool Vibration emission [m/s...
  • Page 58 The Depuy Synthes Small Battery Drive II system is intended for use in the electromagnetic environment specified below. The customer or user of the Depuy Synthes Small Battery Drive II system should ensure that it is used in such an environment.
  • Page 59 The Depuy Synthes Small Battery Drive II system is intended for use in the electromagnetic environment specified below. The customer or user of the Depuy Synthes Small Battery Drive II system should ensure that it is used in such an environment.
  • Page 60 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 Depuy Synthes Small Battery Drive II system is used exceeds the applicable RF compliance level above, the Depuy Synthes Small Battery Drive II system should be observed to verify normal operation.
  • Page 61 Depuy Synthes Small Battery Drive II system The DePuy Depuy Synthes Small Battery Drive II system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Depuy Synthes Small Battery Drive II...
  • Page 62 Ordering Information Adapters Drive unit 310.930 Drill Chuck, small, with Key, for No. 511.110 532.110 Small Battery Drive II (AO/ASIF to Chuck coupling) 338.490 Quick Coupling for Small Air Drill Charger, Battery and Accessories for Battery (AO/ASIF to DHS/DCS coupling) 532.132 Battery Casing for Nos.
  • Page 63 Cutting Tools Detailed ordering information on the cuttings tools for the Small Battery Drive II system with original size pictures can be found in the brochure “Small Bone Cutting Tools”. Detailed ordering information on the special 3-flute drill bits for the Radio lucent Drive can be found in the brochure “Working with the Radiolucent Drive”.
  • Page 64 Limited Warranty and Disclaimer: Depuy Synthes products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied Manufactured or distributed by: warranties, including warranties of merchantability or fitness, are hereby disclaimed. Synthes USA, LLC.

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