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DePuy Synthes

Battery Power Line II Instructions for Use

Содержание BPL II

Страница 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...

Страница 2: ......

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 75: ......

Страница 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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