Synthes Battery Power Line II Instructions For Use Manual
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Synthes Battery Power Line II Instructions For Use Manual

Battery driven power tool system for orthopedics and traumatology
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Battery Driven Power Tool System for Orthopedics and Traumatology
Battery Power Line II
Instructions for Use

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Summary of Contents for Synthes Battery Power Line II

  • Page 1 Battery Driven Power Tool System for Orthopedics and Traumatology Battery Power Line II Instructions for Use...

  • Page 3: Table Of Contents

    • Preparation prior to Reprocessing • Manual Cleaning Instructions • Automated Cleaning Instructions with Manual Pre-cleaning Maintenance and Lubrication Inspection and Function Test Packaging, Sterilization and Storage Repairs and Technical Service Disposal of Waste Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 4 Table of Contents Troubleshooting System Specifications Electromagnetic Compatibility Ordering Information DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 5: General Information

    Introduction General Information Intended use The Battery Power Line II is a battery-powered system to be used for treatment in orthopedic and traumatology surgery, i.e. drilling, reaming, cutting, placing of Kirschner Wires on bone of human skeleton. Battery Reamer/Drill II Drilling...
  • Page 6 The user of the product is responsible for proper use of the equipment during surgery. The Battery Power Line II system is only to be used for patient treatment after careful consultation of the in- Check proper operation of the tool before using it on structions for use.
  • Page 7 • Never place the BPL II in a magnetic environment since the machine might start unintentionally. • Should the system have corroded parts, do not use it any more and send it to the Synthes Service Center. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 8 No oils from other manufacturers must be used. Only use, improper reprocessing and maintenance, damaged Synthes Special Oil (519.970) must be used to lubricate seal, use of non Synthes cutting tools and lubricants or the power tools and attachments. Lubricants with other improper storage and transport.
  • Page 9 Lithium-Ion batteries that Li-Ion should be disposed of in accordance with environment protection requirements. Do not use if package is damaged. Please observe national regulations. See section entitled "Disposal of Waste" on page 68. Battery Power Line II Surgical Technique DePuy Synthes...

  • Page 10: Drive Units

    1565 g/3.4 lbs Cannulation B 4.0 mm Protection against electric shock Protection against water ingress IP X4 Cleaning brush (516.101) and Synthes Special Oil (519.970) included Technical data is subject to tolerances. Mode switch Attachment release ring Facilitates one-handed removal of attachments...
  • Page 11 To open and close the lid of the battery casing and prevent the casing from opening during surgery. Both battery casing locks must be pressed simultaneously to open and close the lid. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 12 To open and close the lid of the battery casing and prevent the casing from opening during surgery. Both battery casing locks must be pressed simultaneously to open and close the lid. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 13 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 20ff. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 14 Note: All BPL/BPL II attachments are fully compatible with the BPL/BPL II handpieces (530.605/530.705). 530.680 Note: Technical data is subject to tolerances and may vary when combining the two systems. Figure 2 DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 15: Universal Battery Charger Ii

    In order that the BPL II battery can be recog- nized and charged by the UBC II, a minimum of firmware version 14.0* is required. If necessary, send the charger to a Synthes representative for a firmware update. For further information on the Universal Battery Charger II please consult the relevant Instructions for Use...
  • Page 16 Assembling and inserting the battery pack Scrubbed person Open the lid of the battery casing as shown in Fig. 1. Ensure the lid of the battery casing is fully open (Fig. 2). Figure 2 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 17 • Do not insert the non-sterile battery into the bat- tery casing whilst a handpiece is attached. Figure 4 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 18 Circulating person Scrubbed person Figure 5b Circulating person Scrubbed person Figure 6 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 19 • Never open a battery casing intraoperatively to insert a new battery. Always replace the whole battery pack with another battery pack prepared before the start of the surgery. Figure 7b Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 20 • To prevent injuries, the mode switch of the drive unit should always be in the off position when inserting or removing the battery pack. • Installing the battery pack just before use prevents unwanted discharge of battery capacity. Figure 8 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 21 (DSEM/PWT/0615/0068). No other sterilization methods are allowed. Precautions: Do not wash, rinse, drop or apply force to the battery (530.630). This will destroy it with possible secondary damage. Scrubbed person Figure 10 Figure 11 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 22 Do not store or transport batteries haphazardly in a box When the battery is not in use, store it in the Synthes or drawer where they may short-circuit each other or be Universal Battery Charger II (05.001.204). This will guar- short-circuited by other metal objects.
  • Page 23 60°C/140°F or incinerate the battery cells. • Never expose batteries to temperatures over 60°C/140°F. The maximum exposure time at 60°C/140°F is 72 hours. • Do not dismantle, open or shred batteries. Battery Power Line II Surgical Technique DePuy Synthes...

  • Page 24: Battery Reamer/Drill Ii (530.705)

    For clockwise rotation, turn the For counterclockwise rotation turn mode switch to the FWD position. the mode switch to the REV position. For safety, turn the mode switch to the OFF position. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 25: Attachments For Battery Reamer/Drill Ii

    Properly functioning tools are essential to the success of an operation. For this reason, used tools must be checked for wear and/or damage after each use and replaced if necessary. Figure 2 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 26 340 rpm and a maximum torque of 15 Nm. Technical data is subject to tolerances. Please refer to notes and precautions on page 25. The following notes apply to all attachments. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 27 – If the reamer head blocks, the speed trigger is released immediately. – The correct function of the speed trigger (imme- diate stop of system when the trigger is released) is checked before the reaming process. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 28 Replace damaged or worn components. Only use original Synthes key. Remove instrument Turn the key counterclockwise to open the jaws. Remove the instrument. Figure 2 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 29 Ensure the instrument shaft is centered in the chuck. Remove instrument Open the chuck jaws by holding on to the retaining ring and manually turning the chuck. Remove the instrument. Figure 2 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 30 It is not necessary to pull back the collar of the attachment to insert the instrument. Remove instrument Pull back the collar of the attachment and remove the instrument (Fig. 2). Figure 2 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 31 (Fig. 1). Release the collar, pulling lightly on the instrument to ensure it is secure. Remove instrument Push forward on the collar of the attachment and remove the instrument (Fig. 1). Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 32 Accepts cutting tools and instruments with a Hudson fitting. Trinkle Quick Coupling, modified (530.793), Drill speed Trinkle Quick Coupling, modified (530.783), Ream speed Accepts cutting tools and instruments with a modified Trinkle fitting. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 33 (Fig. 1). Release the collar, pulling lightly on the instrument to ensure it is secure. Remove instrument Pull back the collar of the attachment and remove the instrument (Fig. 1). Figure 1 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 34 Note: It is not necessary to pull back the collar of the attachment to insert the instrument. Remove instrument Pull back the collar of the attachment and remove the instrument (Fig. 1). DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 35 B 1.5 mm to 4.0 mm, in any length (as shown on page 3). Technical data is subject to tolerances. Please refer to page 34 for instructions on insertion and removal of Kirschner wire/guide pin. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 36 Set the mode switch on the drive unit to REV (reverse). Pull the attachment lever toward the drive unit to grip the wire/pin (Fig. 3). Press the trigger while pulling backward to remove the wire/pin from the bone. Figure 3 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 37 Set the mode switch on the drive unit to REV (reverse). Pull the attachment lever toward the drive unit to grip the pin (Fig. 2). Press the trigger while pulling backward to remove the pin from the bone. Figure 2 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 38 Adapter for Radiolucent Drive. 530.741 Adapter for Radiolucent Drive 511.300 Radiolucent Drive The Adapter for Radiolucent Drive allows the Radio- lucent Drive to be used with the Battery Reamer/Drill II. 511.300 530.741 530.705 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 39 For further information on the Radiolucent Drive and on the special 3-fl ute spiral drill bits please consult the relevant Instructions for Use (DSEM/PWT/0417/0167) or your local Synthes offi ce. Figure 3 Figure 4 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 40 – Hitting a nail: Remove the drill bit until the flutes are visible, and reaim the drill bit or exchange the drill bit if necessary. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 41: Battery Oscillator Ii (530.710)

    For further information on the System Specifi cations and Duty Cycle, please refer to page 76f. Locked symbol Drive unit is off for safety Drive unit is on for sawing Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 42 Pull the sliding sleeve back and rotate the saw head to adjust the sawing plane (adjustable through 360° in 45° increments, Fig. 2). Figure 1 Release the sliding sleeve and turn the saw head slightly until it locks in place. Figure 2 DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 43 Open the saw blade coupling fully by twisting the lock- ing knob and remove the oscillating saw blade (Fig. 3). Instructions for handling saw blades Synthes recommends using a new saw blade for each operation to ensure that the saw blade is optimally sharpened and clean.

  • Page 44: Battery Reciprocator Ii (530.715)

    For further information on the System Specifi cations and Duty Cycle, please refer to page 76f. Locked symbol Drive unit is off for safety Drive unit is of for sawing DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 45 Remove saw blade Figure 1 Turn the release knob in the direction of the arrow to eject the reciprocating saw blade (Fig. 3). Figure 2 Figure 3 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 46 Operating Instructions Battery Reciprocator II (530.715) Instructions for handling saw blades Synthes recommends using a new saw blade for each operation to ensure that the saw blade is optimally sharpened and clean. The following risks are associated with used saw blades: • Thermal necrosis caused by excessive heat build-up...
  • Page 47 Synthes power tools must be serviced and inspected an- nually by the original manufacturer or an authorized site. sheet.
  • Page 48 Any deviation by the processor from the instructions provided should be properly evaluated for effec- tiveness and potential adverse consequences. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 49: Cleaning And Disinfection

    (DSEM/PWT/0615/0068). No other sterilization methods are allowed. Handpieces and attachments must be processed using • manual cleaning • automated cleaning with manual pre-cleaning Figure 3 Note: Clean all movable parts in opened or unlocked position. Battery Power Line II Surgical Technique DePuy Synthes...

  • Page 50: Manual Cleaning Instructions

    Manipulate all moving parts such as triggers, sliding sleeves, attachment release rings, saw blade coupling and switches under running tap water to loosen and remove gross debris. (310 mm) (78 mm) (55 mm) Cleaning brush (516.101) DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 51 For the Quick Coupling for Pins B 3.2 mm (530.796) the brush should only be inserted from the front. Figure 3 Figure 4: Quick Coupling for Kirschner Wires and for Pins B 1.5–4.0 mm (530.791) Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 52 Final rinse with de-ionized or purified water for a mini- mum of 2 minutes (Fig. 7). 10. Dry Dry device using a clean, soft lint-free cloth or medical grade compressed air (Fig. 8). Figure 8 DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 53: Automated Cleaning Instructions With Manual Pre-Cleaning

    The battery must never be cleaned following the auto- mated cleaning with manual pre-cleaning instruc- tions. (310 mm) (78 mm) (55 mm) Cleaning brush (516.101) Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 54 Inspect the cannulations, sliding sleeves, attachment release rings, etc. for visible soil. Repeat steps 1–7 if visible soil remains. Figure 4: Quick Coupling for Kirschner Wires and for Pins B 1.5–4.0 mm (530.791) DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 55 • A lid (68.001.602, 68.001.604) is available for the washing basket. This can be used for sterilization, but is not required for machine washing. • Do not wash the system in the Synthes Vario Case (689.202). • Loading Plan for Washing Basket Full Size ⁄...

  • Page 56: Care And Maintenance

    530.615 Battery Reciprocator 68.001.602 68.001.620 and 68.001.602 Lid for Washing Basket size ¹⁄ ¹ A loading plan for the BPL II Washing Basket Full size 1/1 is available as a single document (DSEM/PWT/1116/0127). DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 57 530.615 Battery Reciprocator 530.660 Sterile Cover 68.001.604 68.001.625 and 68.001.604 Lid for Washing Basket size ½ A loading plan for the BPL II Washing Basket size 1/2 is available as a single document (DSEM/PWT/1116/0128). Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 58 Therefore, devices must be properly lubri- cated after automated cleaning. Furthermore, the device must be serviced at least once per year as specified under the section “Repair and Technical Services” on page 67. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 59: Maintenance And Lubrication

    1 drop of Synthes Special Oil (519.970). Spread the oil by moving the components. Wipe off excess oil with a cloth.
  • Page 60 3 Rear end of the cannulation (Fig. 3) Turn the attachment release ring clockwise and insert 1 drop of Synthes Special Oil (519.970) as shown in fi gure 1a. Then turn the release ring several times. Insert 1 drop of Synthes Special Oil (519.970) in the gap between the seal ring and shaft (Fig.
  • Page 61 4 Trigger shaft. After application of lubricant press the trigger several times. Pull the sliding sleeve back and put 1 drop of Synthes Special Oil (519.970) on the exposed area (Fig. 1a). Then push the sleeve forward and put 1 drop of oil on the other exposed area (Fig.
  • Page 62 3 Trigger shaft. After application of lubricant press the trigger several times. Pull the sliding sleeve back and put 1 drop of Synthes Special Oil (519.970) on the exposed area (Fig. 1a). Then push the sleeve forward and put 1 drop of oil on the other exposed area (Fig.
  • Page 63 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 Surgical Technique DePuy Synthes...
  • Page 64 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 attachment cou- pling (Fig. 2a and 2b). Connect the attachment to the Battery Reamer/Drill II and let it run while the attach-...

  • Page 65: Inspection And Function Test

    Failing to follow these instructions will lead to damage and malfunction, increasing the risk of harm to the user and patient. For further information on inspection and function test, please refer to the BPL II Care and Maintenance Poster (DSEM/PWT/0147/0166). Battery Power Line II Surgical Technique DePuy Synthes...

  • Page 66: Packaging, Sterilization And Storage

    Put cleaned and dry products into their proper places in Loading Plan for Vario Case size ∕ for BPL II the Synthes Vario Case (689.202, Figs. 1a–1d) or the Vario Case (689.202) with lid (689.507) Synthes Washing Baskets (68.001.620, 68.001.625, Dimensions (Length × Width × Height): Figs.
  • Page 67 • The following maximum values must not be • Hot air, ethylene oxide, plasma and formaldehyde exceeded: 138°C over a maximum of 18 minutes. sterilization are not recommended. Higher values can damage the sterilized products. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 68 Use products in the order in which they are received (“first- in, first-out principle“), taking note of any expiration date on the label. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 69: Repairs And Technical Service

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

  • Page 70: Disposal Of Waste

    To prevent damage during shipping use the original packaging to return devices back to Synthes. If this is not Never expose batteries to temperatures over 60°C/140°F. The maximum exposure time at possible, please contact the Synthes affiliate.

  • Page 71: Troubleshooting

    If the UBCII had indicated that the battery was in working condition (green LED illuminating) this indicates that the drive unit is defective and the dam- age was not caused by the battery. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 72 Coupling mechanism is damaged Send damaged item to Synthes Service Center Battery casing lid is difficult to open Sealing ring has not been lubricated Clean and lubricate according to and close care and maintenance guidelines DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 73 Drive unit coupling sleeve is dam- Send damaged drive unit to Synthes aged Service Center Bone, cutting tool and drive unit The cutting tool is blunt Replace the tool heat up during surgery Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 74 Replace the saw blade cannot be coupled the connection geometry of the saw blade Bone and drive unit heat up during The cutting teeth of the saw blade Replace the saw blade surgery are blunt DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 75 Kirschner wire is jammed in the at- Kirschner wire was inserted at an Send Kirschner wire attachment to tachment and cannot be moved angle and is jammed in the attach- Synthes Service Center ment Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 76 Replace cutting tool cessively hot If the recommended solutions do not work, send the power tool to your local Synthes Service Center. For further technical questions or information on our services, please contact your Synthes representative. For troubleshooting for the Universal Battery Charger II please consult the relevant instructions for use (DSEM/PWT/1114/0050).

  • Page 77: System Specifications

    38 °C; 100 °F 72 h 85 % 60 °C; 140 °F 30 % *products have been tested according to ISTA 2A Warning: The machine must not be stored or operated in explosive atmospheres. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 78 Depending on the cutting tool used and the load applied, the heat generated by the handpiece, attach- ment and/or cutting tool can vary. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 79 ** Handpiece 530.710 at idle speed (12 000 Osc./min) *** Handpiece 530.715 at idle speed (14 000 Osc./min) Technical data is subject to tolerances. The values are determined with Synthes saw blades. Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 80 ** Handpiece 530.710 at idle speed (12 000 Osc./min) *** Handpiece 530.715 at idle speed (14 000 Osc./min) Technical data is subject to tolerances. The values are determined with Synthes saw blades. DePuy Synthes Battery Power Line II Surgical Technique...

  • Page 81: Electromagnetic Compatibility

    The BPL II System is suitable for use in profes- sional healthcare facility environment but not in Harmonic emissions IEC 61000-3-2 Not applicable home healthcare or special environment. Voltage fluctuations/flicker emissions Not applicable IEC 61000-3-3 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 82 UT is the a.c. mains voltage prior to application of the test level. Power frequency 30 A/m 200 A/m Power frequency magnetic fields (50/60 Hz) magnetic field should be at levels characteristic of a IEC 61000-4-8 typical location in a typical commercial or hospital environment. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 83 80 MHz to 800 MHz 80 MHz to 800 MHz √P Radiated RF 3 V/m E210 V/m d0.7 IEC 61000-4-3 800 MHz to 2.5 GHz 800 MHz to 2.7 GHz 800 MHz to 6.2 GHz Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 84 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Possible shorter distances outside ISM bands are not considered to have a better applicability of this table. DePuy Synthes Battery Power Line II Surgical Technique...
  • Page 85 An additional factor of 10/3 is used in calcu- lating the recommended separation distance to de- crease the likelihood that mobile/portable commu- nications equipment could cause interference if it is inadvertently brought into patient areas. Battery Power Line II Surgical Technique DePuy Synthes...

  • Page 86: Ordering Information

    530.730 Drill Chuck (930 1/min), with Key (clamping range 0.5 to 7.3 mm), for Battery Power Line For further information please contact your local DePuy Synthes representative. 530.731 Drill Chuck, keyless (clamping range 0.5 to 7.3 mm), for Battery Power Line Cutting tools 530.792...
  • Page 87 68.001.602 Lid for Washing Basket, Full Size 1/1 68.001.602 Lid for Washing Basket, Full Size 1/1 68.001.625 Washing Basket, size 1/2, for Battery Power Line II 68.001.604 Lid for Washing Basket, size 1/2 Battery Power Line II Surgical Technique DePuy Synthes...
  • Page 88 Synthes GmbH For full user instructions and precautions please consult the Eimattstrasse 3 4436 Oberdorf product IFU. Please contact your DePuy Synthes sales Switzerland representative for more information. Tel: +41 61 965 61 11 All surgical techniques are available as PDF files at...

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