Johnson & Johnson DePuy Synthes Small Battery Drive II User Manual Download Page 9

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Small Battery Drive II User Manual DePuy Synthes 7

Legal Manufacturer

Manufacturing date

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

Summary of Contents for 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 2: ......

Page 3: ...eam Attachments 19 Other Rotating Attachments 21 Saw Attachments 26 Care and Maintenance General Information 30 Cleaning and Disinfection 31 Preparation Prior to Reprocessing 31 Manual Cleaning Instru...

Page 4: ...2 DePuy Synthes User Manual Small Battery Drive II Table of Contents System Specifications 50 Electromagnetic Compatibility 56 Ordering Information 60...

Page 5: ...he Small Battery Drive II is intended to be used by qualified health care professionals e g surgeons operating room staff and individuals involved in preparation of the device Indications The Small Ba...

Page 6: ...is cleaned disinfected and serviced after each use in accordance with the process defined in the Care and Maintenance section Compliance with these specifications can considerably extend the service...

Page 7: ...ditions please refer to the section System Specification on page 51 Servicing Warning This system requires regular maintenance service at least once a year in order to maintain its functionality This...

Page 8: ...protection rating according to IEC 60529 Explanation of the general symbols used The following symbols are applied to the device or individual components Information on additional symbols is given in...

Page 9: ...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 Me...

Page 10: ...e of the handpiece OFF or ON position Protective systems The Small Battery Drive II is equipped with three protective systems A thermal overload safety system that shuts off the tool if it becomes too...

Page 11: ...working with the Small Battery Drive II system Only place the tool in an upright position when changing attachments or cutting tools intraoperatively The handpiece must be laid on its side when not i...

Page 12: ...Li Ion battery 532 103 follow the guidelines provided in the STERRAD V PRO sterilization guide To ensure sterility of the battery casing the battery is inserted into the battery casing by two people o...

Page 13: ...ons when inserting the unsterile battery into the sterile battery casing The circulating person must avoid all contact with the outside of the battery casing in order not to contaminate it Should the...

Page 14: ...attery casing with the battery should be kept ready to ensure fast intraoperative change of batteries under sterile conditions Inserting the battery pack into the power tool Guide the battery pack bat...

Page 15: ...72 hours Charging storing and using of Small Battery Drive II batteries 532 103 Charging Warning Only use the Depuy Synthes Universal Battery Charger II 05 001 204 to charge the battery Using a charge...

Page 16: ...otate clockwise as usual Simultaneously pressing the top and bottom triggers causes the tool to immediately switch to oscillating mode The clamped tool oscillates clockwise anticlockwise The speed can...

Page 17: ...n page 7 simultaneously and remove the attachment from the coupling Warnings To avoid injuries the locking mechanism of the tool has to be activated before every manipulation and before placing the to...

Page 18: ...ed with Key clamping range up to B 7 3mm with reverse motion 350 rpm Red Other Rotating Attachments 532 011 Mini Quick Coupling 3500 rpm None 532 012 J Latch Coupling 3500 rpm None 532 022 Quick Coupl...

Page 19: ...0 5 4 0mm 310 93K For drilling 05 001 253 0 5 7 3mm 510 191 For drilling Attachments Drill Attachments Inserting cutting tools Open the jaws of the Chuck using the appropriate key or by hand Insert th...

Page 20: ...be taken when inserting screws with the drive unit Never fully insert screws with the drive unit The last turns or locking should always be done manually Always use an appropriate torque limiting att...

Page 21: ...nto the coupling Maneuver the unlocking ring on the attachment backward and insert the tool such as a drill bit while rotating it slightly until it locks into place Release the ring Check if the tool...

Page 22: ...Use the Chuck with Reverse motion 05 001 254 only with tools that are approved for such use Otherwise the tool may break with subsequent damage To ensure secure fixation of the instrument make sure th...

Page 23: ...usting sleeve K Slightly press the adjusting sleeve axially against the handpiece and rotate the sleeve 2 Apply a slight amount of pressure to insert the Kirschner Wire from the front into the cannula...

Page 24: ...to the Small Battery Drive II and the adapter to the Quick Coupling Position the Radiolucent Drive as far as it will go over the Quick Coupling and the adapter and rotate it into the desired working p...

Page 25: ...e 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 th...

Page 26: ...s can cause an overload Correcting the drilling angle when the cutting edges of the drill bit are completely in the bone Hitting the nail with the drill bit Drilling can be continued after having made...

Page 27: ...th burrs of size M the burr is correctly clamped when the marking M on the burr shank is no longer visible Information on handling burrs Depuy Synthes recommends using a new sterile burr for each oper...

Page 28: ...ade from the direction of the machine Changing the saw blade Fig 2 1 Lock the machine 2 Pull the locking knob O down and turn it counterclockwise 3 Lift and remove the saw blade 4 Use a slight amount...

Page 29: ...tch in the bone Optimal saw performance is achieved by moving the power tool slightly back and forth in the plane of the saw blade so that the blade oscillates beyond the bone on both sides Very preci...

Page 30: ...ade Pull the saw blade coupling toward the handpiece and insert the saw blade while rotating it slightly until it locks into the saw attachment coupling Release the saw blade coupling and check that t...

Page 31: ...switch of the handpiece is in the OFF position and that the locking sleeve on the saw attachment is set to the unlock position Insert the saw attachment in any position into the attachment coupling of...

Page 32: ...ials and personnel in the processing unit Any deviation by the processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences Power tool uni...

Page 33: ...nufacturer of the disinfectant Warnging Inspect battery for cracks and damage Precautions Do not use solvents to disinfect the batteries Battery poles must not contact water or solvents danger of shor...

Page 34: ...er single use items or if reusable be decontaminated at least daily using a solution as detailed in section 3 Spray and wipe Brushes shall be inspected before daily use and discarded if they have degr...

Page 35: ...trate Enzymatic Cleaner 1 8 oz per gallon and clean the device manually under running warm water for a minimum of 5 minutes Manipulate all moving parts under running water Use a soft bristled brush an...

Page 36: ...urified water for a minimum of 2 minutes 10 Dry Dry device using a soft lint free cloth or medical grade compressed air If smaller devices or cannula tions contain residual water blow dry with medical...

Page 37: ...attachments the cleaning brush 519 400 shown below should be used Notes Brushes and other cleaning tools shall be either single use items or if reusable be decontaminated at least daily using a solut...

Page 38: ...2X Concentrate Enzymatic Cleaner 1 8 oz per gallon and clean the device manually under running warm water for a minimum of 5 minutes Manipulate all moving parts under running water Use a soft bristled...

Page 39: ...be used for sterilization but is not required for machine washing Warning Do not wash the system in the Depuy Synthes Graphic Cases 06 550 060 06 550 200 and 06 550 210 Dimensions of the Washing Bask...

Page 40: ...C Thermal disinfection 5 93 C Dry 40 90 C 10 Inspect the device Remove all the devices from the washing basket Inspect the cannulations coupling sleeves etc for visible soil If necessary repeat the ma...

Page 41: ...tion for Use of the Depuy Synthes Special Oil 519 97 and the Small Battery Drive II Care and Maintenance Chart Lubricating the handpiece Fig 1 and 2 Lubricate the trigger shafts and then press the tri...

Page 42: ...I 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 Figure 3...

Page 43: ...Coupling 05 001 250 05 001 251 Quick Coupling for DHS DCS Triple Reamers 532 015 Quick Coupling for Medullary Reaming 532 017 532 018 532 019 532 020 Lubricate the unlocking ring Move it back and fort...

Page 44: ...does not require lubrication The power tools and attachments must only be lubricated with Depuy Synthes Special Oil 519 97 No oil from other manufacturer must be used Lubricants with other compositio...

Page 45: ...remain blocked in the handpiece when pressing on them Check that no residuals prevent the movable parts from moving smoothly Check the coupling sleeves of the handpiece and attachments for smooth ope...

Page 46: ...aturated steam forced air removal pre vacuum minimum 3 pulses Minimum 4 minutes Minimum 132 C Maximum 138 C 20 60 minutes Minimum 3 minutes Minimum 134 C Maximum 138 C 20 60 minutes Drying times gener...

Page 47: ...inted 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...

Page 48: ...for damage resulting from improper use neglected or unauthorized maintenance Faulty devices must not be used If it is no longer possible or feasible to repair the tool it should be disposed of refer...

Page 49: ...risk of infection in case of disposal Always discharge the batteries and isolate the contacts before disposal Risk of fire explosion and burns Do not disassemble crush heat above 60 C 140 F or incine...

Page 50: ...s cannot be coupled to the unit The attachment coupling is blocked by deposits Remove solid objects with a pair of tweezers Warning Immediately turn mode switch to locked position off position Remove...

Page 51: ...ce guidelines The triggers are difficult to move The trigger shafts need to be lubricated Lubricate the trigger shafts as described on page 39 It is difficult to couple the battery casing to the machi...

Page 52: ...A C22 2 NO 60601 1 14 Medical electrical equipment Part 1 2 Collateral Standard Electromagnetic disturbances Requirements and tests IEC 60601 1 2 2014 Ed 4 0 EN 60601 1 2 2015 Medical electrical equip...

Page 53: ...pressure 1060 hPa 1 06 bar 500 hPa 0 5 bar 1060 hPa 1 06 bar 500 hPa 0 5 bar Altitude 0 5000 m 0 5000 m Transportation Temperature Duration Humidity 29 C 20 F 72h uncontrolled 38 C 100 F 72h 85 60 C...

Page 54: ...2 Continuously adjustable speed 0 3500 rpm Weight w battery and battery casing 925 g Operating voltage 14 4 VDC Battery capacity 1 2 Ah Battery type Li Ion Cannulation B 3 2mm Empty battery charging t...

Page 55: ...needs to be taken into consideration during the planning of the surgical intervention Always check the temperature of the system to prevent overheating and possibly harming the patient or user Warning...

Page 56: ...ry 2011 Precaution Carefully observe the above recommended maximum daily exposure time Handpiece Attachment Tool Sound Pressure Level LpA in dB A Sound Power Level LwA in dB A Max daily exposure time...

Page 57: ...1711 5323 03 10 date of testing 18 February 2011 Handpiece Attachment Tool Vibration emission m s2 Max daily exposure Small Battery Drive II 532 110 2 5 8 h AO ASIF Quick Coupling 05 001 250 2 5 8 h...

Page 58: ...sure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Small Battery Drive II system uses RF energy only for its in...

Page 59: ...umidity 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 commercial or hospital environmen...

Page 60: ...P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from xed RF trans...

Page 61: ...distance according to frequency of transmitter m 150 kHz to 80 MHz d 0 35 P 80 MHz to 800 MHz d 0 35 P 800 MHz to 6 2 GHz d 0 7 P 0 01 4mm 4cm 7cm 0 1 11cm 11cm 22cm 1 35cm 35cm 70cm 10 1 11m 1 11m 2...

Page 62: ...532 110 and 532 110 05 001 187 Burr Attachment for Nos 532 001 532 010 532 110 532 110 and 05 001 175 532 021 Oscillating Saw Attachment for Nos 532 001 532 010 532 110 532 110 and 05 001 175 532 023...

Page 63: ...he brochure Working with the Radiolucent Drive Materials Device s Material s Standard s Drive units Stainless Steel ISO 7153 1 Aluminum DIN EN 573 PEEK n a Charger Battery Stainless Steel ISO 7153 1 a...

Page 64: ...d with the devices identified in this brochure for additional information CAUTION Federal Law restricts these devices to sale by or on the order of a physician Some devices listed in this brochure may...

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