Johnson & Johnson BPL II Instructions For Use Manual Download Page 1

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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

Summary of Contents for BPL II

Page 1: ...ne 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 th...

Page 2: ......

Page 3: ...tructions with Manual Pre cleaning 44 Lubrication 48 Inspection and Function Test 54 Packaging Sterilization and Storage 55 Repairs and Technical Service 58 Disposal of Waste 59 Troubleshooting 60 Sys...

Page 4: ...2 DePuy Synthes Battery Power Line II Instructions for Use...

Page 5: ...applications including Drilling Reaming Inserting removing Kirschner wires and pins Cutting bone Battery Reamer Drill II Drilling Kirschner wire insertion Battery Oscillator II Oscillating sawing Rea...

Page 6: ...and Maintenance section Compliance with these specifications can considerably extend the service life of the tool Only use Synthes Special Oil 519 970 to lubricate the tool We recommend using new Synt...

Page 7: ...ropped or contaminating other instruments If the machine has been dropped it should be checked carefully for damage In the event that any damage is visible do not use it anymore and send it to the DeP...

Page 8: ...asing and the attachments when clean DePuy Synthes recommends the use of the specifi cally designed Synthes Washing Baskets 68 001 620 68 001 625 or Synthes Vario Case 689 202 to sterilize and store t...

Page 9: ...test house for IEC 60601 0123 The device meets the requirements of directive 93 42 EEC for medical de vices It is authorized by an independ ent notified body for which it bears the CE symbol Li Ion T...

Page 10: ...5 Nm maximum torque varies with attachment Weight of handpiece including battery pack 1565 g 3 4 lbs Cannulation 4 0 mm Protection against electric shock BF Protection against water ingress IP X4 Clea...

Page 11: ...530 710 Speed 0 12 000 oscillations per minute Deflection 4 5 0 2 25 Weight of handpiece including battery pack 1685 g 3 7 lbs Protection against electric shock BF Protection against wa ter ingress IP...

Page 12: ...minute Stroke 4 mm Weight of handpiece including battery pack 1675 g 3 6 lbs Protection against electric shock BF Protection against water ingress IP X4 Synthes Special Oil 519 970 included Technical...

Page 13: ...er 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...

Page 14: ...the new BPL II battery 530 630 battery casing 530 690 and sterile cover 530 660 as seen in Fig 1 Existing BPL batteries are compatible with BPL II handpieces The existing BPL battery 530 620 battery c...

Page 15: ...tative for a firmware update Sticker as shown on the underside of the charger with firmware version 14 0 For further information on the Universal Battery Charger II please consult the relevant Instruc...

Page 16: ...ttery casing is fully open Fig 2 Ensure that the lid of the battery casing is facing towards the scrubbed person Fig 3 Position the sterile cover securely on top of the bat tery casing Fig 4 Notes The...

Page 17: ...cover from the battery casing Fig 6 Precaution Avoid all contact with the outside of the battery casing in order not to contaminate it Should the non sterile battery or the circulating person s hand...

Page 18: ...precaution a second battery pack battery casing with in serted battery should be kept ready so that the battery pack can be quickly exchanged under sterile conditions during surgery if necessary Never...

Page 19: ...touch the exterior of the battery casing in order to avoid contaminating the battery If this occurs follow the information in the Care and Maintenance section starting on page 39 Store battery in Univ...

Page 20: ...ee that the battery is always fully charged and ready to use The Universal Battery Charger II should always be turned on when a battery is in the charging bay This ensures availability of charged batt...

Page 21: ...case of cell leakage do not allow the leaking fluid to come into contact with skin or eyes In case of contact wash the affected area with co pious amounts of water and seek medical ad vice Faulty batt...

Page 22: ...e and speed vary depending on the attachment see pages 21 ff Ensure that the correct attachment is used for each operation in terms of speed and torque For further information on the System Specificat...

Page 23: ...Drill II aligning the positioning pins of the at tachment with the grooves on the attachment release ring Fig 1 Turn the attachment release ring in the direction of the arrow and push the attachment u...

Page 24: ...ays check that it is properly engaged by pulling it During reaming procedures high torque values must be provided by the power tool to the reaming head to allow efficient bone removal In cases where t...

Page 25: ...prox 340 rpm Maximum torque Drilling approx 6 0 Nm Reaming approx 15 0 Nm Cannulation Drilling 3 2 mm Reaming 4 0 mm Accept round and triangular shafts up to 7 3 mm Technical data is subject to tolera...

Page 26: ...the instrument shaft into the opened chuck Close the chuck manually by rotating the collar keep ing the instrument shaft centered in the jaws Tighten the chuck by turning the key clockwise Fig 2 Note...

Page 27: ...ining ring and manually turning the chuck Fig 1 Insert the instrument shaft into the opened chuck Close the chuck by holding on to the release ring and manually turning the chuck in the opposite direc...

Page 28: ...s and instruments with an AO ASIF quick coupling fitting Technical data is subject to tolerances Insert instrument Introduce the instrument into the attachment then push and turn the instrument until...

Page 29: ...l bits for Synthes intramedullary nailing systems and the Synthes Reamer Irrigator Aspirator RIA system Technical data is subject to tolerances Insert instrument Push forward on the collar of the atta...

Page 30: ...fied 530 793 Drill speed Trinkle Quick Coupling modified 530 783 Ream speed Accept cutting tools and instruments with a modified Trinkle fitting Trinkle Quick Coupling 530 794 Drill speed Trinkle Quic...

Page 31: ...ming fitting Technical data is subject to tolerances Insert instrument Insert the instrument into the attachment and turn it until it locks in place Pull lightly on the instrument to ensure it is secu...

Page 32: ...t of the attachment Fig 2 Note The attachment is spring loaded to prevent the wire pin from falling out Insert Kirschner wire guide pin into bone Pull the attachment lever toward the drive unit to gri...

Page 33: ...hment is spring loaded to prevent the guide pin from falling out Insert guide pin into bone Pull the attachment lever toward the drive unit to grip the pin Fig 2 Set the mode switch on the drive unit...

Page 34: ...The Adapter for Radiolucent Drive allows the Radiolu cent Drive to be used with the Battery Reamer Drill II Assemble Radiolucent Drive Insert the Adapter for Radiolucent Drive into the Bat tery Reamer...

Page 35: ...n go while rotating it slightly Fig 1 Engage the ring on the attachment back to fix the drill bit Check if the drill bit is seated correctly by gently pull ing on it Remove drill bits To remove the dr...

Page 36: ...re 2 Handle the Radiolucent Drive with great care Do not allow contact between the drill bit and the medullary nail Depending on the setting of the image intensifier a zone may appear in the rear of t...

Page 37: ...imal sawing performance is achieved by gently moving back and forth in the plane of the saw blade allowing the blade to oscillate freely slightly beyond the bone Precaution To prevent injuries the mod...

Page 38: ...saw blade for each operation to ensure that the saw blade is optimally sharpened and clean Figure 2 The following risks are associated with used saw blades Thermal necrosis caused by excessive heat bu...

Page 39: ...l sawing performance is achieved by gently moving back and forth in the plane of the saw blade allowing the saw blade to reciprocate freely slightly beyond the bone Precaution To prevent injuries the...

Page 40: ...de for each operation to ensure that the saw blade is optimally sharpened and clean The following risks are associated with used saw blades Figure 2 Thermal necrosis caused by excessive heat build up...

Page 41: ...of this document Follow the enzymatic cleaner instructions for use for correct dilution concentration temperature and water quality Devices should be cleaned in a fresh newly made solution Detergents...

Page 42: ...h dampened with disinfectant or de ionized water Figs 1 and 2 Note If the batteries are contaminated spray disinfectant on an absorbent cloth and wipe clean Take care not to spray the contacts or touc...

Page 43: ...and other cleaning tools shall be either single use items or if reusable be decontami nated at least daily using a solution as detailed below in section 3 Spray and wipe Brushes shall be inspected be...

Page 44: ...Follow the enzymatic cleaner or de tergent manufacturer s instructions for use for correct temperature water quality and concentration dilution Note For the Quick Coupling for Pins 3 2 mm 530 796 the...

Page 45: ...eps 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 Dry Dry device using a clea...

Page 46: ...r ies battery casing or attachments in aqueous solutions or in an ultrasonic bath or use pressur ized water as this will cause damage to the sys tem Brushes and other cleaning tools shall be either si...

Page 47: ...upling for Pins 3 2 mm 530 796 the brush should only be inserted from the front 5 Rinse with tap water Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes Use a...

Page 48: ...bered loading plan as shown in the picture below Ensure that the attachments are positioned in an upright position as shown and fully opened This will ensure that the water can flow off any surfaces N...

Page 49: ...0 C 9 Inspect device Remove all devices from the washing basket Inspect the cannulations sliding sleeves etc for visible soil If necessary repeat the manual pre cleaning automated cleaning cycle Confi...

Page 50: ...ynthes Special Oil 519 970 Spread the oil by moving the components Wipe off excess oil with a cloth For further information on lubrication please refer to the Instruction for Use of the Synthes Specia...

Page 51: ...urn the attachment release ring clockwise and insert 1 drop of Synthes Special Oil 519 970 as shown in figure 1a Then turn the release ring sev eral times Insert 1 drop of Synthes Special Oil 519 970...

Page 52: ...ng 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 1b To lubricate push the sleeve...

Page 53: ...shaft Pull the sliding sleeve back and put 1 drop of Syn thes 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 1b To lub...

Page 54: ...Use 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...

Page 55: ...the BPLII Care and Main tenance Poster 038 000 317 Figure 1 Notes To ensure a long service life and reduce repairs the handpieces attachments and battery cas ings must be lubricated after each use Onl...

Page 56: ...d in the hand piece when pressing on them Check that no residu als prevent the movable parts from moving smoothly Check the release ring of the handpiece and attach ments for smooth operation and chec...

Page 57: ...em for sterilization such as a Sterile Barrier System accord ing to ISO 11607 Care should be taken to prevent pointed and sharp instruments from contact with other objects that may damage the surface...

Page 58: ...ices and cases are as follows Cycle type Sterilization exposure time Sterilization exposure temperature Dry time Minimum 4 minutes Minimum 132 C Maximum 138 C 20 60 minutes Saturated steam forced air...

Page 59: ...ducts 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...

Page 60: ...is not possible please contact the DePuy Syn thes affiliate Faulty devices may not be used If it is no longer possible or feasible to repair the power tool it should be disposed of cf the following s...

Page 61: ...Puy Synthes If this is not possible please contact the DePuy Syn thes affiliate Faulty batteries may not be reused and should be disposed of in an environmentally friendly manner and in accordance wit...

Page 62: ...to run after releasing trigger Trigger is jammed by residue Immediately turn mode switch to lock off position or remove the battery casing Precaution Clean and lubricate trigger according to care and...

Page 63: ...ne and drive unit heat up dur ing surgery The cutting tool is blunt Replace the tool Battery Oscillator II Problem Possible causes Solution Saw blade is difficult to couple or cannot be coupled Genera...

Page 64: ...eed Change attachment Kirschner wire cannot be inserted into the Kirschner wire attachment Kirschner wire attachment is not opened far enough Fully open the adjustment sleeve on the attachment insert...

Page 65: ...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 CA...

Page 66: ...plication and for turning off the system as prescribed If longer periods of constant use are re quired an additional handpiece and or attachment should be used Depending on the cutting tool used and t...

Page 67: ...g Tool Sound Pressure Level LpA in dB A Sound Power Level LwA in dB A Max daily exposure time with out hearing protection Battery Reamer Drill II 530 705 Drill Ream 61 70 8 h Battery Oscillator II 530...

Page 68: ...530 705 Drill Ream 0 22 8 h 8 h Battery Oscillator II 530 710 Saw blade 519 170 4 51 2 h 27 min 8 h Saw blade 05 002 105 12 1 20 min 1 h 21 min Battery Reciprocator II 530 715 Saw blade 511 905 9 74 3...

Page 69: ...an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The BPL or BPL II System uses RF energy only for its internal function Therefore its RF emiss...

Page 70: ...ic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines Not applicable Mains power quality should be that of a typical commerc...

Page 71: ...by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 8...

Page 72: ...Hz d 0 35 P 80 MHz to 800 MHz d 0 35 P 0 8 GHz to 2 5 GHz d 0 7 P 0 01 0 04 m 0 04 m 0 07 m 0 1 0 12 m 0 12 m 0 23 m 1 0 35 m 0 35 m 0 7 m 10 1 11 m 1 11 m 2 3 m 100 3 5 m 3 5 m 7 m For transmitters r...

Page 73: ...or Battery Power Line 530 795 Trinkle Quick Coupling XXL 340 1 min modified for Battery Power Line 530 780 AO ASIF Quick Coupling for Reamers for Battery Power Line 530 791 Quick Coupling for Kirschne...

Page 74: ...ze 1 1 68 001 625 Washing Basket size 1 2 for Battery Power Line II available in Q4 2013 68 001 604 Lid for Washing Basket size 1 2 Example Battery Power Line II Set Trauma Instruments 05 01 204 Unive...

Page 75: ......

Page 76: ...guides are available as PDF files at www synthes com lit This publication is not intended for distribution in the USA 0123 036 000 198 SE_493813 AA 06 2013 40100161 Synthes Inc or its affiliates Subje...

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