Johnson & Johnson DePuy Synthes Battery Power Line II Instructions For Use Manual
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Johnson & Johnson DePuy Synthes Battery Power Line II Instructions For Use Manual

Battery driven power tool system for orthopedics and traumatology
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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
Battery Power Line II (BPL II).
Battery driven power tool system for
orthopedics and traumatology.

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Summary of Contents for Johnson & Johnson DePuy Synthes Battery Power Line II

  • Page 1 Battery Power Line II (BPL II). Battery driven power tool system for orthopedics and traumatology. 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

    Content Introduction General Information Drive Units Operating Instructions Battery Pack Battery Reamer/Drill II Attachments for Battery Reamer/Drill II Battery Oscillator II Battery Reciprocator II Care and Maintenance General Information Preparation prior to Cleaning Manual Cleaning Instructions Automated Cleaning Instructions with Manual Pre-cleaning Lubrication Inspection and Function Test...
  • Page 4 Battery Power Line II Instructions for Use DePuy Synthes...
  • Page 5 Introduction General Information Intended use The Battery Power Line II is a heavy-duty battery- driven system intended for orthopedic and trauma applications including: – Drilling – Reaming – Inserting / removing Kirschner wires and pins – Cutting bone Battery Reamer/Drill II Drilling Reaming Fixing of cutting block with a pin...
  • Page 6 Introduction General Information If the Battery Power Line II is used in conjunction Safety instructions The Battery Power Line II (BPL II) is only to be used with an implant system make sure to consult the cor- for patient treatment after careful consultation of the responding Technique Guide.
  • Page 7 Notes: – Always wear personal protective equipment (PPE) including safety goggles when handling with the BPL II system. – To avoid injuries, the locking mechanism of the tool has to be activated before every manipula- tion and when laying the tool down, i.e. the mode switch has to be in the off position.
  • Page 8 Introduction General Information Accessories/scope of delivery Warranty The Battery Power Line II consists of three different The warranty for the tools and accessories does not handpieces, a battery casing, a battery and a range cover damage of any kind resulting from wear, im- of attachments designed for the system.
  • Page 9 Explanation of symbols used The following symbols are applied to the device or individual components. Caution Date of manufacture Non sterile Consult the provided instructions for use before operating the device. Temperature The device is classified as type BF against electrical shock and leakage current.
  • Page 10 Introduction Drive Units Battery Reamer/Drill II (530.705) Speed 0 – 340 rpm (without attachment) (maximum speed varies with attachment) Torque 0 –15 Nm (without attachment) (maximum torque varies with attachment) Weight of handpiece 1565 g / 3.4 lbs (including battery pack) Cannulation Ø...
  • Page 11 Battery Oscillator II (530.710) Technical data is subject to tolerances. Speed 0 – 12’000 oscillations per minute Deflection 4.5° (0° +/ - 2.25°) Weight of handpiece 1685 g / 3.7 lbs (including battery pack) Protection against electric shock Protection against wa- IP X4 ter ingress Synthes Special Oil (519.970) included...
  • Page 12 Introduction Drive Units Battery Reciprocator II (530.715) Speed 0 –14’000 oscillations Technical data is subject to tolerances. per minute Stroke 4 mm Weight of handpiece 1675 g / 3.6 lbs (including battery pack) Protection against electric shock Protection against IP X4 water ingress Synthes Special Oil (519.970) included Battery Power Line II...
  • Page 13 Battery for Battery Power Line II Art. no. 530.630 Type Li-Ion (Lithium Ion) Voltage 14.8 V Capacity 1.5 Ah / 22.2 Wh Charging Time typically < 60 minutes Technical data is subject to tolerances. Note: For further information on the correct method of charging, storing and using the battery, please refer to page 18ff.
  • Page 14 Introduction Drive Units Compatibility between BPL and BPL II batteries Existing BPL handpieces are compatible with BPL II batteries 530.605 The existing BPL handpieces (530.605, 530.610, 530.615) can be used with the new BPL II battery (530.630), battery casing (530.690) and sterile cover (530.660) as seen in Fig.
  • Page 15 Introduction Universal Battery Charger II The Universal Battery Charger II (05.001.204) in- cludes four independent charging bays. Each charg- ing bay has three slots; the Battery Power Line II battery (530.630) fits into the top slot. Note: In order that the BPL II battery can be recognized and charged by the UBC II, firmware version 14.0* is required.
  • Page 16 Operating Instructions Battery Pack (battery casing with inserted battery) Synthes non-sterile batteries and advanced charging Scrubbed person technology optimize intraoperative battery capacity, maximize battery lifespan and shorten turnaround 530.690 time. One Universal Battery Charger II (05.001.204) for multiple Synthes battery-driven systems simplifies the charging process.
  • Page 17 Circulating person Insert the non-sterile battery through the sterile cover Circulating person into the battery casing (Fig. 5a). Press down on the battery to ensure it is fully seated (Fig. 5b). Note: The shape of the battery ensures that it is inserted with the correct pole alignment.

  • Page 18: Battery Pack

    Operating Instructions Battery Pack (battery casing with inserted battery) Scrubbed person Close the battery casing (Figs. 7a and 7b). Scrubbed person Note: Ensure that both battery casing locks engage and that the lid of the battery casing is closed properly. Always ensure that the lid of the battery casing is totally closed before using the system.
  • Page 19 Removing and disassembling the battery pack Press both release buttons simultaneously on the drive unit to remove the battery pack (Fig. 9). Open the casing by pressing both battery casing locks and remove the battery or hold open the bat- tery casing to allow another person to remove the battery (Fig.
  • Page 20 Operating Instructions Battery Pack (battery casing with inserted battery) Charging, storing and using batteries Do not remove battery from its original packaging until required for use. Charging Only use the Synthes Universal Battery Charger II Do not drop or apply force to the battery. (05.001.204) to charge the battery.
  • Page 21 Notes: – Generally, medical power tools can heat up if in constant use. The cool down times should be observed, see “Duty Cycle” section on page 64, in order to prevent the power tool from exceed- ing its acceptable surface temperature. –...

  • Page 22: Battery Reamer/Drill

    Operating Instructions Battery Reamer/Drill II (530.705) For clockwise rotation, turn the mode switch to the “FWD” position. For counterclockwise rotation, turn the mode switch to the “REV” position. The single variable-speed trigger allows control of the speed from 0 to the maximum rpm. Maximum torque and speed vary, depending on the attachment (see pages 21 ff).

  • Page 23: Attachments For Battery Reamer/Drill Ii

    Operating Instructions Attachments for Battery Reamer/Drill II Instrument 530.705 Battery Reamer/Drill II Precaution: To prevent injuries, the mode switch of the drive unit should always be in the “OFF” position when inserting or removing attachments and cutting tools. Please observe the safety instructions and warnings stated in the instructions when working with attach- ments.
  • Page 24 Operating Instructions Attachments for Battery Reamer/Drill II – Color marking on the attachments The use of irrigation fluid is recommended to cool Some rotating attachments are available in two differ- the cutting tools and prevent heat necrosis. ent speeds for drilling and reaming, respectively. The –...
  • Page 25 Drill Chuck with Key, Drill Speed (530.730) Drill Chuck with Key, Ream Speed (530.732) Maximum speed: Drilling: approx. 930 rpm Drill Chuck (530.730) Reaming: approx. 340 rpm Maximum torque: Drilling: approx. 6.0 Nm Reaming: approx. 15.0 Nm Cannulation: Drilling: Ø 3.2 mm Drill Chuck (530.732) Reaming: Ø...
  • Page 26 Operating Instructions Attachments for Battery Reamer/Drill II Insert instrument Open the chuck jaws by turning the key (510.191) counterclockwise, or by manually turning the collar (Fig. 1). Insert the instrument shaft into the opened chuck. Close the chuck manually by rotating the collar, keep- ing the instrument shaft centered in the jaws.
  • Page 27 Drill Chuck, Keyless, Drill Speed (530.731) Maximum speed: approx. 930 rpm Maximum torque: approx. 6.0 Nm Cannulation: Ø 3.2 mm Accepts round and triangular shafts up to Ø 7.3 mm Technical data is subject to tolerances. Insert instrument Open the chuck jaws by holding on to the retaining ring and manually turning the chuck (Fig.
  • Page 28 Operating Instructions Attachments for Battery Reamer/Drill II AO/ASIF Quick Coupling for drill bits, Drill Speed (530.750) Maximum speed: approx. 930 rpm Maximum torque: approx. 6.0 Nm Cannulation: Ø 2.0 mm Accepts cutting tools and instruments with an AO/ASIF quick coupling fitting Technical data is subject to tolerances.
  • Page 29 Quick Coupling for DHS/DCS Triple Reamers, Drill Speed (530.760) Maximum speed: approx. 930 rpm Maximum torque: approx. 6.0 Nm Cannulation: Ø 3.2 mm Accepts cutting tools and instruments with a large quick coupling fitting. These include DHS/DCS triple reamers, large quick coupling screwdriver shafts, large quick coupling cannulated drill bits for Synthes intramedullary nailing systems and the Synthes Reamer/Irrigator/Aspirator (RIA) system...
  • Page 30 Operating Instructions Attachments for Battery Reamer/Drill II Drilling/Reaming Attachments Maximum speed: Drilling: approx. 930 rpm Reaming: approx. 340 rpm Maximum torque: Drilling: approx. 6.0 Nm Reaming: approx. 15 Nm Cannulation: Drilling: Ø 3.2 mm Reaming: Ø 4.0 mm Technical data is subject to tolerances. Hudson Quick Coupling (530.792), Drill speed Hudson Quick Coupling (530.782), Ream speed Accept cutting tools and instruments with a Hudson...
  • Page 31 AO/ASIF Quick Coupling for Reamers, Reaming Speed (530.780) Maximum speed: approx. 340 rpm Maximum torque: approx. 15 Nm Cannulation: Ø 4.0 mm Accepts cutting tools and instruments with an AO reaming fitting, including intramedullary reaming shafts with the AO reaming fitting. Technical data is subject to tolerances.
  • Page 32 Operating Instructions Attachments for Battery Reamer/Drill II Quick Coupling for Kirschner Wires and for Pins, Drill Speed (530.791) Maximum speed: approx. 930 rpm Maximum torque: approx. 6.0 Nm Cannulation: Ø 4.0 mm Allows insertion and removal of Kirschner wires and guide pins with diameters from Ø...
  • Page 33 Quick Coupling for Pins, Drill Speed (530.796) Maximum speed: approx. 930 rpm Maximum torque: approx. 6.0 Nm Cannulation: Ø 3.2 mm Dedicated attachment to fix knee replacement cut- ting blocks with a pin (as shown on page 3). Allows insertion and removal of Ø 3.2 mm guide pins with round, triangular and flat shafts.
  • Page 34 Operating Instructions Attachments for Battery Reamer/Drill II Radiolucent Drive (511.300) and Adapter for Ra- diolucent Drive (530.741) Maximum speed: approx 1’100 rpm Maximum torque: approx. 1.3 Nm Technical data is subject to tolerances. Instruments 530.705 Battery Reamer/Drill II 530.741 Adapter for Radiolucent Drive 511.300 Radiolucent Drive The Adapter for Radiolucent Drive allows the Radiolu-...
  • Page 35 Insert drill bits Pull the ring on the Radiolucent Drive forward and push the drill bit into the coupling as far as it can go while rotating it slightly (Fig. 1). Engage the ring on the attachment back to fix the drill bit.
  • Page 36 Operating Instructions Attachments for Battery Reamer/Drill II 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 (Fig. 1). After the incision, position the Radiolucent Drive and center the drill bit tip over the locking hole.

  • Page 37: Battery Oscillator

    Operating Instructions Battery Oscillator II (530.710) To operate the drive unit, turn the mode switch to the “ON” position. The single variable-speed trigger allows control of the oscillating frequency from 0 to 12’000 oscillations per minute. When the trigger is released, the power tool stops immediately.
  • Page 38 Operating Instructions Battery Oscillator II (530.710) Insert saw blade Fully open the saw blade coupling by turning the locking knob. Insert an oscillating saw blade into the coupling. Turn the locking knob in the opposite direction to secure the saw blade. Tighten the locking knob (Fig.

  • Page 39: Battery Reciprocator

    Operating Instructions Battery Reciprocator II (530.715) To operate the drive unit, turn the mode switch to the “ON” position. The single variable-speed trigger allows control of the reciprocating frequency from 0 to 14’000 oscilla- tions per minute. When the trigger is released, the tool stops immediately.
  • Page 40 Operating Instructions Battery Reciprocator II (530.715) Insert saw blade Insert a reciprocating saw blade into the coupling and push until the saw blade locks in place (Fig. 1). Lightly pull the saw blade to ensure it is properly seated. Adjust sawing plane Pull the sliding sleeve back and rotate the saw head to adjust the sawing plane (adjustable through 360°...

  • Page 41: General Information

    Care and Maintenance General Information Power tool units and attachments are frequently ex- – Detergents used on the products will be in con- posed to high mechanical loads and shocks during tact with the following materials: stainless steel, use and should not be expected to last indefinitely. aluminum, plastic, and rubber seals.

  • Page 42: Preparation Prior To Cleaning

    Care and Maintenance Preparation prior to Cleaning Disassembly Before cleaning, remove all instruments and attach- ments from the power tool. Remove the battery casing from the handpiece and then remove the battery itself. To clean the battery and the charger, wipe them off with a clean, soft and lint-free cloth dampened with disinfectant or de-ionized water (Figs.

  • Page 43: Manual Cleaning Instructions

    Care and Maintenance 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 (Fig. 1). For cannulations of the handpiece and attachments, the cleaning brush (516.101) should be used.
  • Page 44 Care and Maintenance Manual Cleaning Instructions 4. Clean with detergent Clean the device manually under running warm wa- ter using an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth to remove all visible soil and debris (Figs.
  • Page 45 6. Visually inspect device Inspect the cannulations, sliding sleeves, attachment release rings, etc. for visible soil. Repeat steps 1-6 until no visible soil remains. 7. Final rinse with de-ionized/purified water Final rinse with de-ionized or purified water for a minimum of 2 minutes (Fig. 7). Figure 7 8.

  • Page 46: Automated Cleaning Instructions With Manual Pre-Cleaning

    Care and Maintenance Automated Cleaning Instructions with Manual Pre-cleaning Notes: – Manual pre-cleaning prior to automated cleaning is important to ensure cannulations and other dif- ficult to access areas are clean. – Alternative cleaning procedures other than in the procedure described below (including manual pre-cleaning) have not been validated by DePuy Synthes.
  • Page 47 4. Clean with detergent Clean the device manually under running warm wa- ter using an enzymatic cleaner or detergent for a minimum of 5 minutes. Manipulate all moving parts under running water. Use a soft-bristled brush and/or soft lint-free cloth to remove all visible soil and debris (Figs.
  • Page 48 Care and Maintenance Automated Cleaning Instructions with Manual Pre-cleaning 7. Load Synthes Washing Basket Please use the specially designed tray for machine Dimensions (Length x Width x Heights): washing as supplied by Synthes (68.001.620, Washing Basket without Lid: 500 x 250 x 118 mm 68.001.625).
  • Page 49 8. Automated cleaning cycle parameters Note: The washer/disinfector should fulfill requirements specified in ISO 15883. Step Duration (minimum) Cleaning Instructions Rinse 2 minutes Cold tap water Pre-wash 1 minute Warm water (≥40°C); use detergent Clean 2 minutes Warm water (≥45°C); use detergent Rinse 5 minutes Rinse with de-ionized (DI) or purified water...

  • Page 50: Lubrication

    Care and Maintenance Lubrication To ensure a long service life and smooth operation, it is recommended that the accessible moving parts of the handpiece, battery casing and attachment are lubricated after each use with 1 drop of Synthes Special Oil (519.970). Spread the oil by moving the components.
  • Page 51 Battery Reamer/Drill II (530.705) The following individual parts must be lubricated with 1 drop of Synthes Special Oil (519.970): 1 Attachment release ring (Figs. 1a and 1b) 2 Trigger shaft 3 Rear end of the cannulation Turn the attachment release ring clockwise and insert 1 drop of Synthes Special Oil (519.970) as shown in figure 1a.
  • Page 52 Care and Maintenance Lubrication Battery Oscillator II (530.710) The following individual parts must be lubricated with 1 drop of Synthes Special Oil (519.970): 1 Saw blade coupling 2 Locking knob for the saw blade quick coupling 3 Sliding sleeve for positioning the saw blade (Figs.
  • Page 53 Battery Reciprocator II (530.715) The following individual parts must be lubricated with 1 drop of Synthes Special Oil (519.970): 1 Saw blade coupling 2 Sliding sleeve for positioning the saw blade (Figs. 1a and 1b) 3 Trigger shaft Pull the sliding sleeve back and put 1 drop of Syn- thes Special Oil (519.970) on the exposed area (Fig.
  • Page 54 Care and Maintenance Lubrication Lubricating the battery casing (530.690) Place oil on the complete inside edge of the battery casing and distribute it evenly. Open and close the lid several times to lubricate the sealing. Wipe off excess oil with a cloth (Fig.1). Battery Casing for Battery Power Line II (530.690) Figure 1 Battery Power Line II...
  • Page 55 Lubricating the attachments After each use lubricate all moving parts of the attachment with 1 drop of Synthes Special Oil (519.970) (Fig. 1). Spread the oil by moving the components. Wipe off excess oil with a cloth. Insert 1 drop of Synthes Special Oil (519.970) in the gap between the seal ring and shaft of the attach- ment coupling (Fig.

  • Page 56: Inspection And Function Test

    Care and Maintenance Inspection and Function Test Visually inspect for damage and wear. 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 hand- piece when pressing on them.

  • Page 57: Packaging, Sterilization And Storage

    Care and Maintenance Packaging, Sterilization and Storage Packaging Put cleaned and dry products into their proper places in the Synthes Vario Case (689.202, Figs. 1a – 1d) or the Synthes Washing Basket (68.001.620, Fig. 2, 68.001.625). Additionally, use an appropriate sterili- zation wrap or re-usable rigid container system for sterilization, such as a Sterile Barrier System accord- ing to ISO 11607.
  • Page 58 Care and Maintenance Packaging, Sterilization and Storage Sterilization Notes: – Remove batteries from battery casings. Do not sterilize batteries as they will be damaged and no longer function. – If the Vario Case (689.202) is sterilized in a ster- ilization wrap, use the lid (689.507). –...
  • Page 59 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 60: Repairs And Technical Service

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

  • Page 61: Disposal Of Waste

    Care and Maintenance Disposal of waste In most cases, faulty power tools can be repaired (refer to the previous section “Repairs and Technical Service”). Please send devices that are no longer used to your local DePuy Synthes representative. This ensures that they are disposed of in accordance with the na- tional application of the respective directive.
  • Page 62 Troubleshooting General Problem Possible causes Solution Drive unit does not start No battery in the drive unit Insert charged battery Battery is discharged Charge or replace battery Battery is defect Replace battery Drive unit is defect Send drive unit to DePuy Synthes Service Center Drive unit did not cool down after Allow to cool to room temperature...
  • Page 63 Battery Reamer/Drill II Problem Possible causes Solution Attachments cannot couple to Coupling is blocked by residue Precaution: Immediately turn drive unit mode switch OFF (Lock position). Remove solid particles with pick- ups. Clean and lubricate accord- ing to care and maintenance guidelines.
  • Page 64 Troubleshooting Attachments and Cutting Tools Problem Possible causes Solution Attachments cannot couple to Coupling is blocked by residue Precaution: Immediately turn drive unit mode switch OFF (Lock position). Remove solid particles with pick- ups. Clean and lubricate accord- ing to care and maintenance guidelines.
  • Page 65 System Specifications The device meets the following standards EN 60601-1 / IEC 60601-1 / EN 60601-1-2 / IEC 61000-6-1/ IEC 61000-6-2 / IEC 61000-6-3 IEC 61000-6-4 Medical electrical devices 10PB With regard to electrical shock, fire and mechanical hazards only in accordance with EN 60601-1 and ANSI/AAMI ES60601-1 (2005) and CAN / CSA C22.2 No.
  • Page 66 System Specifications Duty Cycle Precautions: Intermittent operation type S9, according to IEC – Carefully observe the above recommended duty 60034-1 cycles. – Above mentioned duty cycles can be reduced due to higher loads applied and due to ambi- Cycles ent temperatures above 20°C / 68°F. s on s off Drilling and tapping...
  • Page 67 Declaration of the emission sound pressure level and the sound power level according to EU Directive 2006/42/EC Measurement of the sound pressure level [LpA] is carried out in accordance with standard EN ISO 11202. Measurement of the sound power level [LwA] is carried out in accordance with standard EN ISO 3746. Handpiece Attachment Cutting Tool...
  • Page 68 System Specifications Declaration of vibration emission according to EU Directive 2002/44/EC Vibration emissions [m/s ] tested according to EN ISO 5349-1. Handpiece Attachment Cutting Tool Declara- Max. daily Max. daily tion [m/s exposure time exposure time to reach limit to reach limit value [2.5 m/s value [5 m/s Battery Reamer/Drill II*...
  • Page 69 Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 1: Emissions Guidance and manufacturer’s declaration – electromagnetic emissions The Battery Power Line (BPL) or Battery Power Line II (BPL II) System is intended for use in the electromag- netic environment specified below.
  • Page 70 Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 2: Immunity (all devices) Guidance and manufacturer’s declaration – electromagnetic immunity The BPL or BPL II System is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of BPL or BPL II System should assure that it is used in such an environment.
  • Page 71 Table 4: Immunity (not life-supporting devices) Guidance and manufacturer’s declaration – electromagnetic immunity The BPL or BPL II System is intended for use in the electromagnetic environment specified below. The cus- tomer or the user of the BPL or BPL II System should assure that it is used in such an environment. Electromagnetic environment –...
  • Page 72 Electromagnetic Compatibility Accompanying Documents According to IEC 60601-1-2, 2007, Clause 6 Table 6: Recommended separation distances (not life-supporting devices) Recommended separation distances between portable and mobile RF communications equipment and the BPL or BPL II System The BPL or BPL II System is intended for use in the electromagnetic environment in which radiated RF distur- bances are controlled.
  • Page 73 Ordering Information For further information please contact your local DePuy Synthes rep- Drive units resentative. 530.705 Battery Reamer/Drill II 530.710 Battery Oscillator II 530.715 Battery Reciprocator II Cutting tools Detailed ordering information on the saw blades for the BPL II system can be found in the brochure ”Saw Blades”...
  • Page 74 Ordering Information Example Battery Power Line II Set – Joint Replacement Instruments 05.01.204 Universal Battery Charger II 530.705 Battery Reamer/Drill II 530.710 Battery Oscillator II 530.715 Battery Reciprocator II 530.630 Battery f/ Battery Power Line II, 3ea 530.660 Sterile Cover f/ Battery Power Line II, 3ea 530.690 Battery Casing f/ Battery Power Line II, 3ea 530.796...
  • Page 76 All technique guides are available as PDF files at Synthes GmbH www.synthes.com/lit Eimattstrasse 3 CH-4436 Oberdorf This publication is not intended for www.synthes.com 0123 distribution in the USA.

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