Small Battery Drive II User`s Manual
Contents
1. Small Battery Drive Il Universal battery power tool system for use in traumatology hand and foot surgery User s Manual ORU EN Small Battery Drive Il CVA PTE Fe instruments and implants Qa A y d d A i lt a N T Y b HA EAJ T approved by the AO Foundation Vw i i es Table of Contents Introduction General Information 3 Small Battery Drive II Handpiece 6 Use 8 Attachments General Information 12 Drill Attachments 14 Screw Attachments t9 Ream Attachments 16 Other Rotating Attachments 18 Saw Attachments 23 Other Attachments 27 Care and Maintenance General Information 28 Preparation Prior to Cleaning 29 Manual Cleaning Instructions 30 Mechanical Automated Cleaning Instructions with Manual Pre cleaning 32 Lubrication ES Function Control 39 Packaging Sterilization and Storage 40 Repairs and Technical Service 42 Disposal 43 Small Battery Drive II User s Manual Synthes Table of Contents Troubleshooting 44 System Specifications 46 Electromagnetic Compatibility 51 Ordering Information 55 Synthes Small Battery Drive II User s Manual Introduction General Information Intended use The Small Battery Drive Il is a battery driven power tool for use in traumatology hand and foot surgery involving Surgical procedures such as drilling burring reaming pin and wire placement cutting of bone a2. Changing the saw blade Fig 2 and 3 1 Lock the machine 2 Pull the locking knob O down and turn it clockwise 3 Lift and remove the saw blade 4 Use aslight amount of pressure to insert the new saw blade and turn it to the desired position The desired positions can be offset trom each other at 45 angles 5 Place your thumb on the saw blade coupling to hold the saw blade and turn the locking mechanism counterclockwise until the saw blade is fixed 6 Unlock the power tool Figure 1 Figure 2 Figure 3 Small Battery Drive II User s Manual Synthes 23 Attachments Positioning the saw blade The saw blade can be adjusted in the desired position vertically and horizontally at an angle of 45 see the earlier sections Positioning the saw attachment and Changing the saw blade Using the oscillating saw attachment The saw blade must already be oscillating when the saw is applied to the bone Do not apply strong pressure to the saw blade as this will delay the cutting process and the saw teeth will catch 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 precise cuts can be made when the saw blade is guided steadily Imprecise cuts arise due to used blades excess pressure or jamming the saw blade Instructions for handling the saw blades
3. Small Battery Drive II User s Manual Synthes 27 Care and Maintenance General Information Power tool units and attachments are frequently exposed to high mechanical loads and shocks during use and should not be expected to last indefinitely Proper handling and maintenance help extend the useful life of surgical instruments Gentle care and maintenance with proper lubrication can substantially increase the reliability and life of the system components Synthes recommends annual servicing and inspection by the original manufacturer or its exclusive sales outlets The manufacturer assumes no warranty for damages arising trom improper use neglected or unauthorized servicing Precautions Reprocessing must be performed immediately after each USE Cannulations unlocking sleeves and other narrow sites require special attention during cleaning Cleaners with pH 7 9 5 are recommended The use of cleaners with higher pH values can depending on the cleaner cause the discoloration of aluminum and its alloys plastics or compound materials and they should only be used considering the data regarding material compatibility according to its data sheet At pH values higher than 11 the surfaces of stainless steel can also be affected Follow the enzymatic cleaner or detergent manufacturer s instructions for use for the correct dilution concentration temperature exposure time and water quality If
4. If the unsterile battery contacts the outside of the casing the casing must be resterilised before being used in the OR To close the casing cover press it firmly to ensure that it Is completely closed Fig 9 and 10 so that the locking mechanism properly engages Always ensure that the cover is totally closed before using the system Sterilize the insertion shield after each use to ensure aseptic conditions when inserting the unsterile battery into the sterile battery casing Inserting the battery pack into the power tool Guide the battery pack battery casing with inserted battery trom below into the shaft of the handpiece Fig 11 The shape of the battery casing prevents the battery trom being inserted incorrectly Check if the battery pack is seated correctly by gently pulling on it Removing the battery pack from the power tool Simultaneously press the release buttons for the battery casing with one hand Fig 12 and use the other hand to remove the battery pack from the handpiece Figure 9 Figure 10 Figure 11 Figure 12 Small Battery Drive II User s Manual Synthes 9 Small Battery Drive Il Charging storing and using Small Battery Drive Il batteries 532 103 Charging The batteries should always be charged before use Only use the Synthes Universal Battery Charger Il 05 001 204 to charge the batteries Using another charger can damage the battery Charge the batt
5. 25 cycles lt 5 U TOSS Note U is the AC mains voltage prior to the application of the test level Power frequency 50 60 Hz 3 A m 100 A m Power frequency magnetic fields should be magnetic field at levels characteristic of a typical location in a IEC 61000 4 8 typical commercial or hospital environment 52 Synthes Small Battery Drive Il User s Manual Table 3 Immunity not life supporting devices Guidance and manufacturer s declaration electromagnetic immunity The Synthes Small Battery Drive II system is intended for use in the electromagnetic environment specified below The customer or user of the Synthes Small Battery Drive Il system should ensure that it is used in such an environment Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Synthes Small Battery Drive II system including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Immunity test standard IEC 60601Ttest level Compliance level Recommended separation distance Conducted RF 3 Vrms Not applicable d 0 35 VP IEC 61000 4 6 150 kHz to 80 MHz 150 kHz to 80 MHz Radiated RF E1 10 V m d 0 35 VP IEC 61000 4 3 3 V m measured 20 V m 80 MHz to 800 MHz 80 MHz to 800 MHz 80 MHz to 800 MHz Radiated RF E2 10 V m d 0 35 VP IEC 61000 4 3 3 V m m
6. see page 6 Always check correct functioning before use on patient Never place the Small Battery Drive Il on a magnetic Surface since the machine might start unintentionally Pay particular attention to all the instructions in the individual sections that are identified with Caution Components that are no longer useful must be disposed of in accordance with the local and national regulations Always wear personal protective equipment PPE including satety goggles when working with the Small Battery Drive Il system Small Battery Drive Il User s Manual Synthes 7 Small Battery Drive Il Use Before initial use brand new tools and accessories must undergo the entire reprocessing process and the batteries should be charged Completely remove protective caps and films Inserting the battery in the battery casing To ensure sterility the battery is inserted into the battery casing by two people one of whom is wearing sterile garments lll LUA Lis l l l Figure 1 Figure 2 1 The person with the sterile garments holds the sterile battery casing If the casing is not opened the same person presses the central button to unlock Fig 1 turns the lid sideways 90 as indicated by the arrow Fig 2 and pulls to open Fig 3 Leave the locking mechanism swung outward 2 The person wearing the sterile garments places the sterile insertion shield on the battery casing Fig 4 and chec
7. LWA are carried out in accordance with standard EN ISO 3746 Information according to test protocol no 1711 5323 03 10 date of testing 17 February 2011 Handpiece Attachment Tool Handpiece Sound Power Max daily Sound Level Level LWA in exposure time LpA in dB A dB A without hearing protection Small Battery 63 gt 8h Drive Il 532 110 AO Quick Coupling 64 gt 8h 05 001 250 Oscillating Saw Saw blade 73 gt 8h Attachment 532 021 532 045 Saw blade 85 94 8h 532 067 Oscillating Saw Saw blade 84 92 gt on Attachment 532 023 03 000 313 Saw blade 85 94 Sh 03 000 316 Large Oscillating Saw Saw blade 83 92 gt 8h Attachment 532 026 03 000 394 Saw blade 85 96 8 h 03 000 396 Small Battery Drive Il User s Manual Synthes 49 System Specifications Declaration of vibration emission according to the EU guideline 2006 42 EC Annex The assessment of the vibration emissions m s2 is to be made to the hand arm system according to EN ISO 8662 Information according to test protocol no 1711 5323 03 10 date of testing 18 February 2011 Handpiece Attachment Tool Declaration m s2 Max daily exposure Small Battery Drive II lt 2 5 No limitation 532 110 AO Quick Coupling lt 2 No limitation 05 001 250 Oscillating Saw Saw blade vertical lt 2 5 No limitation Attachment 532 021 532 045 horizo
8. Synthes recommends using a new blade for each operation to ensure that the saw blade is optimally sharpened and clean The following risks are associated with used blades Necrosis caused by excessive heat build up Infection caused by residue Extended cutting time due to poor saw performance Figure 4 24 Synthes Small Battery Drive Il User s Manual Oscillating Saw Attachment II Crescentic Technique 532 023 The Oscillating Saw Attachment II is essentially designed for use with semicircular saw blades for example 03 000 313S guided by a 1 6 mm Kirschner Wire It can also be used with saw blades with a shaft extension for example 03 000 340S tor reaching difficult to access sites Inserting the saw blade 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 the saw blade Is correctly fixed by gently pulling on the saw blade Removing the saw blade Pull the saw blade coupling towards the handpiece to release the saw blade Precautions The saw attachments may only be used with the handpiece in the ON mode Never use the attachments in oscillating drilling mode Q The appropriate surgical technique J9091 should be observed to ensure the safe and successful application of the Crescentic Technique Small Battery Drive II User
9. EPD console and handpiece does not Start Up Console is not switched on or not connected Connect console and or switch it on Handpiece is not connected to console Connect handpiece to console 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 Small Battery Drive II User s Manual Synthes 45 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 decives gente U UL UL 60601 1 Only in conformance with EN 60601 1 and UL 60601 1 and CAN CSA C22 2 No 601 1 in reference to electrical shock fire casualty IEC 60601 1 2005 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 Environmental conditions Operation Storage Temperature 10 40 C 10 40 C Relative humidity 10 90 10 90 Atmospheric pressure 500 1060 hPA 500 1060 hPA Altitude 380 5570m 380 5570 m Transportation Temperature 29 60 C for max 72 h Relative humidity 10 90 Atmospheric pressure 500 1060 hPA Technical Data Small Battery Drive Il 532 110 Continuously adjustable soeed 0 3500 rpm Weight w battery 918g Operating voltage 14 4 VDC Batte
10. None Saw 532021 Oscillating Saw Attachment 19200 cpm None Attachments 532 023 Oscillating Saw Attachment II Crescentic Technique 19200 cpm None 532 026 Large Oscillating Saw Attachment 19200 cpm None Other a lee eo Torque Limiter 1 5 Nm for AO Quick Coupling None Attachments 511 776 Torque Limiter 0 8 Nm with AO Quick Coupling None S1777 Torque Limiter 0 4 Nm with AO Quick Coupling None Technical data is subject to tolerances Specifications are approximate and may vary from one device to another or as a result of power supply fluctuations Small Battery Drive Il User s Manual Synthes is Attachments Drill Attachments AO Quick Coupling 05 001 250 For tools with an AO coupling shaft Mounting and removing the tools Insert the tool into the attachment from the front applying slight pressure and turning slightly It is not necessary to operate the coupling sleeve of the attachment To disconnect push the coupling sleeve of the attachment back and remove the tool e two Chucks available as Drill Attachments for the Small Battery Drive II system Article number Clamping range Spare key Comments 5 001 252 0 4 0 mm 310 93K For drilling 05 001 253 0 7 3 mm 510 19 For drilling Inserting cutting tools Open the jaws of the Chuck using the appropriate key or by hand Insert the shaft of the tool into the open drill chuck and close it by twisting the chuck Make sure that the shaf
11. ionized purified water Final rinse with de ionized or purified water for a minimum of 2 minutes 8 Dry Dry device using a soft lint free cloth or clean compressed air Small Battery Drive Il User s Manual Synthes 31 Care and Maintenance Mechanical Automated Cleaning Instructions with Manual Pre cleaning Important Manual pre cleaning prior to mechanical automated cleaning disinfection Is important to ensure that cannulations and other difficult to access areas are clean Alternative cleaning disinfection procedures other than in the procedure described below including manual precleaning have not been validated by Synthes 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 For cannulations of the handpiece and attachments the cleaning brush 519 40 should be used Note Do not use pointed objects for cleaning 2 Manipulate moving parts Manipulate all moving parts such as the triggers sleeves and switches under running tap water to loosen and remove gross debris 3 Spray and wipe Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes Follow the enzymatic detergent manufacturer s directions for correct temperature water quality i e pH hardness and concentration dilution 32 Synthes Small Battery Drive Il User
12. large diameter may not be able to be inserted with the AO Quick Coupling as the torque may not suffice The attachment is also suitable for application at a lower rom and or higher torque Small Battery Drive II User s Manual Synthes 15 Attachments Ream Attachments Quick Couplings for Medullary Reaming AO Quick Coupling 532 017 Hudson Quick Coupling 532 018 Trinkle Quick Coupling 532 019 Trinkle Quick Coupling modified 532 020 The Quick Couplings for Medullary Reaming enable the use of flexible shafts with the appropriate coupling geometry Reverse motion which can damage the flexible shafts is prevented by a special mechanical system Inserting cutting tools into 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 is seated correctly in the coupling by gently pulling on it Removing cutting tools Push the unlocking ring on the attachment backward and remove the tool Precautions Do not use Quick Couplings for Medullary Reaming for acetabular reaming They may only be used for medullary reaming Check the cutting tool for wear and or damage after each use and replace if necessary Quick Coupling for DHS DCS Triple Reamers 532 015 For DHS DCS Triple Reamers can also be used to open the medullary cavity with
13. s Manual 4 Clean with detergent Clean the device manually under running warm water 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 Follow the enzymatic cleaner or detergent manufacturer s instructions for use for correct temperature water quality and concentration dilution 5 Rinse with tap water Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes Use a syringe pipette or water jet to flush lumens and channels Actuate joints handles and other movable device features in order to rinse thoroughly under running water 6 Visually inspect device Inspect the cannulations coupling sleeves etc for visible soil Repeat steps 1 6 until no visible soil remains 7 Load washing basket Place devices in the specially designed tray for machine washing supplied by Synthes 68 001 610 Ensure that all cannulations handpiece and attachments if applicable are positioned vertically i e in an upright position as shown Note Specitic lid 68 001 602 is available for the washing basket Small Battery Drive Il User s Manual Synthes 33 Care and Maintenance 8 Automated cleaning cycle parameters Note The washer disinfector should fulfill the requirements as specified in ISO 158
14. 101 532 110 and 05 001 175 05 001 252 Chuck Drilling Speed with Key clamping range up to 4 0 mm 05 001 253 Chuck Drilling Speed with Key clamping range up to 7 3 mm 05 001 254 Chuck Reaming Speed with Key clamping range up to 7 3 mm with reverse motion 532015 Quick Coupling for DHS DCS triple reamers for Nos 532 001 532 010 532 101 532 110 and 05 001 175 532 017 532 018 932 019 932 020 532 022 05 001 187 932 021 532023 932 026 332 031 511 30 F77 511 776 le AO Quick Coupling for Medullary Reaming for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Hudson Quick Coupling tor Medullary Reaming for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Trinkle Quick Coupling for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Trinkle Quick Coupling modified tor Nos 532 001 532 010 532 101 532 110 and 05 001 175 Quick Coupling for Kirschner Wires 0 6 to 3 2 mm Tor Nos 532 001 532 010 532 101 and 532 110 Burr Attachment for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Oscillating Saw Attachment for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Oscillating Saw Attachment II Crescentic Technique for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Large Oscillating Saw Attachment for Nos 532 001 532 010 532 101 532 110 and 05 001 175 Adapter for Radiolucent Drive for Nos 532 001 532 010 53
15. 2 101 532 110 and 05 001 175 Radiolucent Drive Torque Limiter 1 5 Nm for AO ASIF Quick Coupling Torque Limiter 0 8 Nm for AO ASIFQuick Coupling Torque Limiter 0 4 Nm for AO ASIFQuick Coupling Small Battery Drive II User s Manual Synthes DO Ordering Information Console 05 001 002 Basic Console for Electric Pen Drive and Small Accessories 68 001 255 689 507 68 001 253 519 40 68 001 610 68 001 602 saie eT 532 024 310 935 210 19 Electric Drive 05 001 108 Light Adapter for Small Battery Drive Il Vario Case size 1 1 for Colibri Il and Small Battery Drive Il without Lid without Contents Lid stainless steel size 1 1 for Vario Case Vario Case for attachments for Colibri Il Small Battery Drive Il and Small Electric Drive Cleaning Brush for Compact Air Drive Power Drive Small Battery Drive Il and Small Electric Drive Washing Basket size 1 1 for Colibri Il and Small Battery Drive Il Lid tor Washing Basket size 1 1 Oil Dispenser with Synthes Special Oil 50 ml Cleaning Brush for Oscillating Saw Attachment II 532 023 Spare Key for Drill Chuck clamping range up to 4 0 mm Spare Key for Drill Chuck clamping range up to 7 3 mm Saw blades for 532 021 Usable Cut Sterile length Width thickness mm mm mm 532 041S 15 6 0 4 532 0425 15 10 0 4 532 0435 15 16 0 4 532 0445 18 4 0 4 532 0455 22 8 0
16. 4 532 0465 22 12 0 4 532 0475 31 6 0 4 532 0485 31 10 0 4 532 0615 27 6 0 6 532 0625 27 10 0 6 532 0635 27 14 0 6 532 0645 50 10 0 6 532 0655 50 14 0 6 532 0665 50 20 0 6 532 0675 50 27 0 6 56 Synthes Small Battery Drive Il User s Manual Parallel saw blades for 532 021 Saw blades for 532 023 Usable Usable Blade Cut Sterile Length length Width Cut Sterile length width thickness Diameter mm mm mm mm mm mm mm 532 081S 47 1 25 12 90 cut 03 000 311S 26 5 13 3 0 60 18 2 0mm shortening 03 000 312S 25 16 3 0 60 22 532 082S 47 1 25 12 90 cut 03 000 313S 30 17 9 0 60 18 2 5mm shortening 03 000 316S 30 21 9 0 60 22 532 083S 47 1 25 12 90 cut 03 000 340S 7 12 0 0 38 70 3 0 mm shortening 93 999 3415 12 11 5 0 38 70 532 084S 47 1 25 12 90 cut 03 000 3425 12 95 0 38 70 4 0 mm shortening 03 000 343S 12 4 5 0 38 70 532 085S 47 1 25 12 90 cut 5 0 mm shortenin J Saw blades for 532 026 532 091S 47 1 25 12 A5 cut Usable 2 0 mm shortening length Radius Cut thickness 532 092S 47 1 25 12 45 cut mm mm mm 2 5mm shortening 03 000 390 45 12 0 60 532 093S 47 1 25 12 A5 cut 03 000 391 45 15 0 60 ae a shortening 93 999 392 45 18 0 60 cut 03 000 393 45 21 0 60 SEs 03 000 394 A5 24 0 60 532 095S A7 25 12 45 cut es l E 03 000 395 50 27 0 60 03 000 396 50 30 0 60 Cutting tools Detailed ordering informatio
17. 83 Step Duration Cleaning instructions minimum Rinse 2 minutes Cold tap water Pre wash 1 minute Warm water gt 40 C use detergent Cleaning 2 minutes Warm water gt 45 C use detergent Rinse 5 minutes Rinse with de ionized DI or purified water PURW Thermal disinfection 5 minutes Hot DI water gt 93 C Dry 40 minutes 2 90 C 9 Inspect the device Remove all the devices trom the washing basket Inspect the cannulations coupling Sleeves etc for visible soil If necessary repeat the manual pre clean automated cleaning cycle Confirm that all parts are completely dry Mechanical cleaning disinfection is an additional stress for power equipment especially for seals and bearings Therefore systems must be properly lubricated and regularly sent to be serviced at least once per year 34 Synthes Small Battery Drive Il User s Manual Lubrication The power tool and attachments should be regularly lubricated to ensure a long service life and smooth operation It is recommended that the accessible moving parts of the handpiece the battery casing and attachments are lubricated with 1 drop of Synthes special oil 519 97 distribute the oil by moving the components Wipe off the excess oil with a cloth Lubricating the handpiece Fig 1 and 2 Lubricate the trigger shafts and then press the triggers several times Lubricate the attachment release buttons and then press the buttons several times Lubricate the
18. anism is not tight Tighten the locking knob of the saw blade coupling The mode selector switch is set to Q Turn the mode selector switch to ON The Kirschner wire is inserted in the handpiece and cannot be moved forward The Kirschner wire was inserted from the rear Lock the machine by turning the mode selector switch to OFF Remove the attachment hold the drive shaft opening down and shake out the Kirschner wire Bone and tool heat up during surgery Cutting edges of the tool are blunt Replace the tool 44 Synthes Small Battery Drive Il User s Manual Problem Possible causes Solution It is difficult to close the battery casing The battery casing seal has become dry trom repeated cleaning Lubricate the seal as described on page 36 The battery casing knob is difficult to turn The locking mechanism needs to be lubricated Lubricate the locking mechanism as described on page 36 The knob mechanism needs to be lubricated Lubricate the knob mechanism as described on page 36 The triggers are difficult to move The trigger shafts needs to be lubricated Lubricate the trigger shafts as described on page 35 It is difficult to couple the battery casing to the machine The battery casing release buttons need to be lubricated Lubricate the battery casing release buttons as described on page 35 Small Battery Drive Il is used with the
19. ar in the rear of the Radiolucent Drive that is not radiolucent However this does not inhibit aiming and working with the device To protect the gears the Radiolucent Drive is equipped with a slip clutch that disengages in case of an overload and emits an audible rattling noise The following procedures 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 continue after making the following corrections Correcting the drilling angle Remove the drill bit until the flutes are visible and then restart the drilling Hitting a nail Remove the drill bit until the flutes are visible and re aim the drill bit or exchange the drill bit if necessary Small Battery Drive II User s Manual Synthes 21 Attachments Burr Attachment 05 001 187 The Burr Attachment is size M It can be used with Burrs for Burr Attachments of the Electric Pen Drive and Air Pen Drive systems It is compatible with burr types M and L but it is recommended to use burrs of size M Changing burrs 1 Lock unit 2 Turn the release sleeve for burrs M until it engages in the UNLOCK position and remove the tool 3 Insert the new tool as far as possible turn it slightly until it locks in place and then turn the release sleeve for burrs into the LOCK position until it engages When using an M sized burr it i
20. battery casing release buttons from both the outside and inside see Fig 2 and then press the buttons several times Lubricate the mode selector switch and then move it several times Lubricate the attachment coupling Figure 1 Figure 2 ORS A e Small Battery Drive Il Small Battery Drive II User s Manual Synthes 25 Care and Maintenance 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 Figure 4 36 Synthes Small Battery Drive II User s Manual Attachments Lubricate moving parts of all the attachments Exception the Radiolucent Drive 511 30 does not require lubrication Chuck 05 001 252 05 001 254 Lubricate the jaws and toothed rim Open and close the drill chuck several times Quick Coupling for Kirschner Wires 532 022 Lubricate the tension lever and clamping mechanism Hold the Quick Coupling up and add one drop of oil into the attachment hole and on the holder of the lever Fig 5 Move the tension lever several times Mini Quick Coupling 532 011 J Latch Coupling 532 012 AO Quick 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
21. blocks the speed trigger is released immediately the correct function of the speed trigger immediate stop of the system when the trigger is released is checked before the reaming process 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 Precautions Do not use the Small Battery Drive II for acetabular reaming Check the cutting tool for wear and or damage after each use and replace if necessary To ensure good fixation of the tool make sure the toothed rims on the drill chuck and key are not worn Small Battery Drive Il User s Manual Synthes 17 Attachments Other Rotating Attachments Mini Quick Coupling 532 011 J Latch Coupling 532 012 Accepts mini quick couplings or Stryker J latch bits Mounting and removing the tools To connect the tool pull the coupling sleeve back and then introduce the tool while rotating slightly To disconnect push the coupling sleeve of the attachment back and remove the tool Quick Coupling for Kirschner Wires 532 022 Kirschner Wires of any length with a diameter of 0 6 3 2 mm can be used with the Quick Coupling for Kirschner Wires _ Adjust the Kirschner Wire diameter according to the label on the adjusting sleeve K Slightly press the adjusting sleeve axially against the handpiece and rotate the sleeve 2 Apply a slight amount of press
22. ces in packaging materials Sterile Barrier System e g wraps or reusable rigid container systems steam quality device materials total mass sterilizer performance and varying cool down time Precautions The following maximum values may not be exceeded 138 C over a maximum of 18 minutes Higher values can damage the sterilized products Do not accelerate the cooling process Hot air ethylene oxide plasma and formaldehyde sterilization are not recommended Please see memo DJ8555 Use of Rigid Sterilization Containers with Synthes Loaded Graphic Cases for more information regarding the use of rigid sterilization containers The memo can be found at www synthes com 40 Synthes Small Battery Drive II User s Manual Storage Storage conditions tor 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 Tirst in first out principle taking note of any expiration date on the label Small Battery Drive II User s Manual Synthes 41 Care and Maintenance Repairs and Technical Service The tool should be sent to the Synthes office for repair if it Is faulty or malfunctions Contaminated products have to run through the complete reprocessing procedure befor
23. e allowed to cool for 30 minutes If this is observed the system will be prevented trom overheating and possibly harming the patient or user The user is responsible for the application and for turning off the system as prescribed If longer periods of constant use are required an additional handpiece and or attachment should be used These recommendations for times of use for the attachments of the Small Battery Drive Il have been determined under average load with an ambient air temperature of 20 C 68 F Depending on the cutting tool used and on the load applied the heat generation of the handpiece attachment and or cutting tool can vary Always control the temperature of the system to prevent overheating and possibly harming the patient or user Precautions Carefully observe the above recommended duty cycles Always use new cutting tools to prevent the heating up of the system due to reduced cutting performance Careful maintenance of the system will reduce heat development in the handpiece and the attachments The Small Battery Drive Il must not be stored or operated in an explosive atmosphere 48 Synthes Small Battery Drive II User s Manual Declaration of the emission sound pressure level and the power level according to the EU guideline 2006 42 EC Annex Measurements of the sound pressure level LpA are carried out in accordance with standard EN ISO 11202 Measurements of the sound power level
24. e being sent to the Synthes office for repair or technical service Faulty devices may not be used If it is no longer possible or feasible to repair the tool it should be disposed of refer to the following section Disposal Other than the above mentioned care and maintenance no further maintenance work may be carried out independently or by third parties Synthes recommends the device and accessories such as attachments to be regularly once a year serviced by the original manufacturer or an authorized site Precaution The manufacturer assumes no responsibility for damage resulting trom neglected or unauthorized maintenance 42 Synthes Small Battery Drive Il User s Manual Disposal In most cases faulty tools can be repaired refer to the previous section Repairs and Technical Service This device contains Lithium lon batteries that should be disposed of in an environmentally friendly manner The European Battery Directive 2006 66 EC applies to this device Precautions Contaminated products have to run through the complete reprocessing procedure so that there is no danger of infection in case of disposal Risk of fire explosion and burns Do not disassemble crush heat above 100 C or incinerate the battery cells Please send tools that are no longer used to your local Synthes representative This ensures that they are disposed of in accordance with the national application of
25. e cleaning brush 519 40 should be used Note Do not use pointed objects for cleaning Manipulate moving parts Manipulate all moving parts such as the triggers sleeves and switches under running tap water to loosen and remove gross debris Spray and wipe Spray and wipe the device using a neutral pH enzymatic solution for a minimum of 2 minutes Follow the enzymatic detergent manufacturer s directions for correct temperature water quality i e pH hardness and concentration dilution Clean with detergent Clean the device manually under running warm water 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 Follow the enzymatic cleaner or detergent manufacturer s instructions for use for correct temperature water quality and concentration dilution 30 Synthes Small Battery Drive II User s Manual 5 Rinse with tap water Rinse the device thoroughly using cool to lukewarm running water for a minimum of 2 minutes Use a syringe pipette or water jet to flush lumens and channels Actuate joints handles and other movable device features in order to rinse thoroughly under running water 6 Visually inspect device Inspect the cannulations coupling sleeves etc for visible soil Repeat steps 1 6 until no visible soil remains 7 Final rinse with de
26. e processor from the instructions provided should be properly evaluated for effectiveness and potential adverse consequences 28 Synthes Small Battery Drive Il User s Manual Preparation Prior to Cleaning Disassembly Disassemble device if applicable Remove all instruments and attachments trom the power tool and remove battery from casing or handpiece To clean the batteries and the charger wipe them off with a clean soft and lint free cloth dampened with disinfectant or deonized water Fig 1 and 2 Important Do not use solvents to disinfect the batteries Battery poles must not contact water or solvents danger of short circuiting Return batteries to charger 05 001 204 after each use Fig 3 Never immerse the handpiece lid or attachments in aqueous solutions or in an ultrasonic bath as this could decrease the service life of the system Handpieces and attachments may be processed using a manual cleaning and or b automated cleaning with manual pre cleaning Note Clean all movable parts in opened position Figure 1 Figure 2 Figure 3 Small Battery Drive Il User s Manual Synthes 29 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 For cannulations of the handpiece and attachments th
27. easured 20 V m 800 MHz to 2 5 GHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Where 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 trom fixed RF transmitters as determined by an electromagnetic site survey gt should be less than the compliance level in each frequency range lt Interference may occur in the vicinity of equipment marked with the following symbol G Notes At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people o oO Possible shorter distances of outside ISM bands are not considered to have a better applicability of this table Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Synthes Small Battery Drive Il system is used exceeds the applicable RF compliance level above the Synthes Small Battery Drive Il system should be observed to verif
28. elease buttons for attachment Release buttons for battery casing Knob for the battery casing cover NI Safety system The Small Battery Drive Il is equipped with a safety system that prevents the machine from being unintentionally Started To lock and unlock the tool turn the mode selector switch 4 to the appropriate setting on the front plate of the handpiece OFF Q or ON position SYNTHES Small Battery Drive N CON HU BRWYDN Protective systems The Small Battery Drive Il is equipped with three protective systems A thermal overload safety system that shuts off the tool if it becomes too hot during use After cooling the tool can be used again An exhaustive discharge protection ensures that the battery does not completely discharge This protects the battery and extends its life An internal fuse in the battery that blows in case of unintended short circuit This prevents excessive heat fire or explosion If this happens the battery can not be used anymore Speed and rotational direction control Mode selector switch in the ON position The bottom trigger 2 gradually controls the forward speed up to approx 1440 rom with the AO quick coupling When the bottom and top triggers 2 and 3 are pressed at the same time the tool operates in reverse The top trigger 3 can be depressed first Depressing the bottom trigger 2 with the top trigger already depressed will ensure the tool will start in reverse and al
29. er s Manual Synthes 3 Introduction Accessories scope of delivery The Small Battery Drive Il consists of a handpiece one or several battery casings and batteries and a range of attachments and accessories designed for the system For the system to operate properly only Synthes cutting tools should be used Special auxiliaries such as cleaning brushes and Synthes oil are available for cleaning and servicing the system No oils trom other manufacturers must be used Only Synthes oil 519 97 must be used Lubricants with other compositions can cause jamming can have a toxic effect or can have a negative impact on the Sterilization results Only lubricate the power tool and the attachments when clean Synthes recommends the use of a case specifically designed tor the Synthes Small Battery Drive Il and the specifically designed Washing Basket 68 001 610 to sterilize and store the system The following components are essential to ensure proper operation Handpiece 532 110 Battery Casing 532 132 Battery 532 103 Insertion Shield 532 104 Universal Battery Charger Il 05 001 204 Atleast one attachment of the system Please refer to the end of this user s manual for an overview of the components of the system Storage and transport Please use the original packaging for dispatch and transport If this is no longer available please contact the Synthes office Warranty The warranty fo
30. eries within an ambient temperature range of 0 C to 40 C Storage When the battery is not being used store it in the Synthes Universal Battery Charger Il 05 001 204 This will prevent it from discharging and the battery will be fully charged and ready to use Never load the batteries in a charger other than the Universal Battery Charger Il 05 001 204 The charging station should always be turned on when a battery is in the charging base This ensures availability and prevents discharge Use Only insert the battery pack directly before using the Small Battery Drive Il This saves battery energy and prevents having the need to change it during surgery Only use batteries for the indicated purpose Do not transport or store the batteries together with materials that conduct electricity and can cause a short circuit This can damage the battery and generate heat which can cause burns Never open the battery 532 103 Never expose batteries to temperatures above 60 C Do not apply force to the batteries and do not let them Tall Never use damaged batteries they can damage the power tool Follow the additional information in the chapter Care and Maintenance starting on page 28 as well as the user manual of the Synthes Universal Battery Charger II J8895 10 Synthes Small Battery Drive II User s Manual Using the Small Battery Drive II with the light adapter The Small Battery Drive Il can also be opera
31. ers m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people An additional factor of 10 3 is used in calculating the recommended separation distance to decrease the likelihood that mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas 54 Synthes Small Battery Drive Il User s Manual Ordering Information Drive unit 532 110 Small Battery Drive Il Charger Battery and Accessories for Battery 532 132 Battery Casing for Nos 532 101 and 532 110 with Locking for Lid 522103 Battery for Nos 532 101 and 532 110 532 104 Insertion Shield for Nos 532 101 and 532 110 05 001 204 Universal Battery Charger Il Attachments 532 011 Mini Quick Coupling for Nos 532 001 532 010 532 101 532 110 and 05 001 175 532 0012 J Latch Coupling for Nos 532 001 532 010 532 101 532 110 and 05 001 175 05 001 250 AO Quick Coupling for Nos 532 001 532 010 532 101 532 110 and 05 001 175 05 001 251 Screw Attachment with AO Quick Coupling for Nos 532 001 532 010 532
32. f fire explosion and burns Do not disassemble crush heat above 100 C or incinerate the battery cells 4 IPX4 C Do not reuse Products intended for single use must not be reused Reuse or reprocessing e g cleaning and resterilization may compromise the structural integrity of the device and or lead to device failure which may result in patient injury illness or death Furthermore reuse or reprocessing of single use devices may create a risk of contamination e g due to the transmission of infectious material from one patient to another This could result in the injury or death of the patient or user Synthes does not recommend reprocessing contaminated products Any Synthes product that has been contaminated by blood tissue and or bodily fluids matter should never be used again and should be handled according to hospital protocol Even though they may appear undamaged the products may have small defects and internal stress patterns that may cause material fatigue Temperature Relative humidity EA pressure 59 Duty cycle type according to IEC60034 1 Ingress protection rating according to IEC 60529 Image intensifier control Small Battery Drive II User s Manual Synthes 9 Small Battery Drive II Handpiece Attachment coupling Trigger for speed regulation Trigger for switching to reverse oscillating drilling Mode selector switch Battery pack battery casing with inserted battery R
33. forth several times Oscillating Saw Attachment 532 021 Lubricate the locking mechanism and the saw blade coupling Open and close the locking mechanism several times Oscillating Saw Attachment II 532 023 Lubricate the unlocking sleeve the tool holder and the attachment coupling Move it back and forth several times Large Oscillating Saw Attachment 532 026 First lubricate and then move all movable parts Saw blade coupling slot between the saw blade coupling and attachment Locking sleeve of the attachment coupling slots on both sides Coupling pins Opening of the attachment coupling Figure 5 Figure 6 Small Battery Drive Il User s Manual Synthes 3 Care and Maintenance Precautions To ensure a long service life and reduce repairs the power tool and all attachments must be lubricated after each use Exception The Radiolucent Drive 511 30 does not require lubrication The power tool and accessories may only be lubricated with Synthes special oil 519 97 The composition of the vapor permeable and biocompatible oil is optimized for the specific requirements of the power tool Lubricants with other compositions can cause the power tool to jam and be toxic Only lubricate the power tool and attachments when clean 38 Synthes Small Battery Drive II User s Manual Function Control Visually inspect for damage and wear Check the handpiece con
34. g attachments AO Quick Coupling 532 013 05 001 250 Chuck 05 001 252 05 001 253 Quick Coupling for Kirschner Wires 532 022 Do not use the oscillating mode with the oscillating saw attachments You can only switch to reverse by turning the mode selector switch to ON position The maximum speed of a cutting tool is slightly less in oscillation mode than in normal mode Compatibility between Small Battery Drive and Small Battery Drive II Existing Small Battery Drive battery packs are compatible with Small Battery Drive II handpiece The small 12 VDC battery pack of the Small Battery Drive 532 003 with battery casing 532 002 as well as the large 14 4 VDC battery pack 532 033 with battery casing 532 032 can both be used with the new Small Battery Drive Il handpiece 532 110 Existing Small Battery Drive handpiece is compatible with Small Battery Drive II battery pack The existing Small Battery Drive handpiece 532 010 can be used with the new battery pack of the Small Battery Drive Il 532 103 with battery casing 532 132 Important The information contained in this user s manual concerns the Small Battery Drive Il system For more information on the Small Battery Drive please refer to the Small Battery Drive User s Manual J2968 To prevent injury the machine must be locked with the mode selector switch 4 when coupling and removing attachments and tools and before laying it down
35. ix the drill Check if the drill bit is seated correctly by gently pulling on it Removing the drill bit Follow the same procedure in reverse order 05 001 250 Ei 532 031 511 30 Small Battery Drive Il User s Manual Synthes 19 Attachments Using the Radiolucent Drive D Before positioning the Radiolucent Drive align the image intensifier until the distal locking hole of the medullary nail is round and easily visible D 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 the drive Swing the drive up and center it precisely so that the drill bit appears as a round point and the locking hole is visible around it The target ring also assists the centering The locking hole can now be drilled directly 20 Synthes Small Battery Drive Il User s Manual Precautions Grip the coupled Radiolucent Drive tightly when switching on the power tool particularly if the power tool is held face down Only special 3 flute spiral drill bits can be used Your Synthes representative will be glad to provide you with additional information on which drill bits can be used 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 appe
36. ks if it is seated correctly The sterile insertion shield ensures that the unsterile battery does not contact the outside of the sterile casing 3 The person not wearing sterile garments carefully guides the unsterile battery through the sterile insertion shield Fig 5 As an orientation the two symbols on the battery and the sterile insertion shield should face each other Fig 6 The same person presses it completely into the battery casing to ensure a correct seat Fig 7 This person may not contact the outside of the battery casing 4 The person not wearing sterile garments grasps the flanges on the sterile insertion shield and removes it from the battery casing Fig 8 5 The person wearing the sterile garments closes the casing cover from the outside without contacting the battery or the inside of the casing After having closed the casing cover turn the lid sideways 90 until it clicks Figure 5 Figure 6 Figure 7 Figure 8 8 Synthes Small Battery Drive II User s Manual Precautions Normally one battery is sufficient for one surgery A second battery pack battery casing with the battery should be kept ready to ensure fast intraoperative changing of batteries under sterile conditions if necessary Never open a battery casing intraoperatively to insert a new battery Always replace the whole battery pack with another battery pack which should have been prepared before the start of the surgery
37. low for precise speed control The speed of rotation may be controlled by how much depression is placed on trigger 2 When the bottom trigger 2 is released the tool immediately stops 6 Synthes Small Battery Drive II User s Manual Mode selector switch in the oscillating drilling position Q When both triggers are depressed the tool operates in oscillating rotation The top trigger 3 can be depressed first Depressing the bottom trigger 2 with the top trigger already depressed will ensure the tool will start in reverse and allow for precise speed control The speed of the oscillation may be controlled by how much depression is placed on trigger 2 When the top trigger 3 Is released the tool returns to normal forward rotation Oscillating drilling Q mode To protect soft tissue when drilling and inserting Kirschner wires the Small Battery Drive II has an electronically controlled oscillating mode To preset the oscillating mode switch the mode selector switch to Q position Pressing the bottom trigger causes the tool to rotate clockwise as usual Simultaneously pressing the top and bottom triggers causes the tool to immediately switch to oscillating mode The clamped tool oscillates clockwise counterclockwise The speed can be changed by means of the bottom trigger After the top trigger Is released the tool returns to normal clockwise rotation Precautions Oscillating mode may only be used with the followin
38. most of the Synthes nailing systems Mounting and removing the tools To connect the tool push the coupling sleeve forward and then introduce the tool while turning slightly To disconnect push the coupling sleeve of the attachment forward and remove the tool 16 Synthes Small Battery Drive Il User s Manual Chucks There is one chuck available as a Ream Attachment for the Small Battery Drive Il system Article number Clamping range Spare key Comments 05 001 254 0 7 3 mm 510 19 For drilling and medullary reaming with reverse motion Inserting cutting tools Open the jaws of the chuck using the appropriate key or by hand Insert the shaft of the tool into the open drill chuck and close it by twisting the chuck Make sure that the shaft lies central to the three jaws Tighten the drill chuck with the key Make sure that the teeth of the key engage correctly in the toothed rim of the chuck Removing cutting tools Open the chuck with the key and remove the tool Warnings During reaming procedure high torque values must be provided by the power tool to the reaming head to allow efficient bone removal In cases where the reaming head suddenly is blocked these high torque values can be transferred onto the user s hand wrist and or the patient s body In order to prevent injuries it therefore is essential that the power tool is held in an ergonomical position with a firm grip if the reamer head
39. n on the cuttings tools for the Small Battery Drive Il system with original size pictures can be found in the Sagittal Saw Blades brochure 44099 Detailed ordering information on burrs compatible with the Small Battery Drive Il system can be found in the Cutting Tools for Electric Pen Drive brochure J6366 Precaution Saw blades labeled Single Use should not be used repeatedly Small Battery Drive Il User s Manual Synthes 57 SYNTHES Power Tools 2013 Synthes Inc or its affiliates All rights reserved Synthes USA 1302 Wrights Lane East West Chester PA 19380 Telephone 610 719 5000 To order 800 327 6887 Fax 800 327 6661 E mail info anspach com Synthes Canada Ltd 2566 Meadowpine Boulevard Mississauga Ontario L5N 6P9 Telephone 905 567 0440 To order 800 668 1119 Fax 905 567 3185 www synthes com Synthes is a trademark of Synthes Inc or its affiliates Printed in U S A 2 13 J11582 B
40. nd hard tissue Safety instructions The Small Battery Drive Il is only to be used for patient treatment after careful consultation of the instructions for use The Small Battery Drive Il is designed for use by physicians and trained medical personnel DO NOT use any component if damage is apparent DO NOT use any component if the packaging is damaged DO NOT use this equipment in the presence of oxygen nitrous oxide or a mixture consisting of flammable anesthetics and air To ensure the proper operation of the tool only use Synthes Original accessories Before the first and every subsequent use power tools and their accessories attachments have to run through the complete reprocessing procedure Protective covers and foils must be fully removed before sterilization For the tool to function properly Synthes recommends cleaning and servicing it after each use in accordance with the process recommended in the chapter Care and Maintenance Compliance with these specifications can considerably extend the service life of the tool Only use Synthes oil 519 97 to lubricate the tool Efficiently working cutting tools are the basis for successful surgery Therefore it is mandatory to check used cutting tools after every use for wear and or damage and to replace them if necessary We recommend using new Synthes cutting tools for every surgery Cutting tools must be cooled with irrigation liquid to prevent heat necrosis The
41. ntal lt 2 5 No limitation Saw blade vertical 3 73 No limitation 532 067 horizontal 6 58 4h 35 min Oscillating Saw Saw blade 225 No limitation Attachment 532 023 03 000 313 Saw blade 6 2 5h 12 min 03 000 316 Large Oscillating Saw Saw blade 14 02 1h 1 min Attachment 532 026 03 000 394 Saw blade 18 44 35 min 03 000 396 50 Synthes Small Battery Drive II User s Manual Electromagnetic Compatibility Accompanying Documents According to IEC 60601 1 2 2007 Clause 6 Table 1 Emission Guidance and manufacturer s declaration electromagnetic emissions The Synthes Small Battery Drive Il system is intended for use in the electromagnetic environment specified below The customer or user of the Synthes Small Battery Drive Il system should ensure that it is used in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions Group 1 The Synthes Small Battery Drive Il system uses RF CISPR 11 energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Synthes Small Battery Drive Il system is suitable CISPR 11 for use in all establishments including domestic establishments and those directly connected to the Harmonic emissions Not applicable public low voltage power supply network that IFC 61000 3 3 supplies buildings used for dome
42. page 6 during each manipulation Only use original attachments and tools trom Synthes Damage that arises from using attachments and tools made by other manufacturers is not covered by the warranty Never use an attachment in reverse mode with an old flexible shaft as this could cause serious injury to the patient Figure 1 B SYNTHES 12 Synthes Small Battery Drive Il User s Manual Article Product Speed Color coding Drill 05 001 250 AO Quick Coupling 1440 rom Blue Attachments 05 001 252 Chuck Drilling Speed with Key clamping range up to 4 0 mm 1440 rpm Blue 05 001 253 Chuck Drilling Speed with Key clamping range up to 7 3 mm 1440 rom Blue Screw 05 001 251 Screw Attachment with AO Quick Coupling 384 rom Red Attachments neam ont 532 017 AO Quick Coupling for Medullary Reaming 384 rom Red 532 018 Hudson Quick Coupling for Medullary Reaming 384 rom Red 532 019 Trinkle Quick Coupling for Medullary Reaming 384 rom Red 532 020 Trinkle Quick Coupling modified for Medullary Reaming 384 rom Red 532 015 Quick Coupling for DHS DCS triple reamers 384 rom Red 05 001 254 Chuck Reaming Speed with Key clamping range up to 384 rom Red 7 3 mm with reverse motion Other 532 011 Mini Quick Coupling 3840 rpm None Rotating 532 012 J Latch Coupling 3840 rom None Attachments 539 922 Quick Coupling for Kirschner Wires 960 rom None 05 001 187 Burr Attachment 16000 rom None FTD Radiolucent Drive 3840 rpm
43. r the tools and accessories does not cover damage of any kind resulting from improper use damaged seals or Improper storage and transport The manufacturer does not accept liability for damage resulting from repairs or maintenance carried out by unauthorized sites 4 Synthes Small Battery Drive II User s Manual Explanation of the general symbols used Li lon Caution Read the provided Instructions for Use before operating the device Consult the Instructions for Use before operating the device The device is classified as type BF against electrical shock and leakage current The device is suitable for use on patients according to the standards defined by CSA 601 1 IEC 60601 1 and UL 60601 1 IEC 60601 1 2005 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 Do not immerse device in liquids Small Battery Drive Il With regard to electrical shock Tire mechanical hazards only in accordance with UL 60601 1 and CAN CSA C22 2 No 601 1 IEC 60601 1 2005 ANSI AAMI ES60601 1 2005 CAN CSA C22 2 No 60601 1 2008 The device meets the requirements of directive 93 42 EEC for medical devices It is authorized by an independent notified body for which it bears the CE symbol This device contains Lithium lon batteries that should be disposed of in an environmentally friendly manner The European Battery Directive 2006 66 EC applies to this device See section Disposal on page 43 Precaution Risk o
44. ry capacity 1 2 Ah Battery type Li lon Cannulation O 3 2mm Empty battery charging time max 60 min cectical shock e Degree of protection against the penetration of water IPX4 Noise level in the operating position approx 65 dB A 46 Synthes Small Battery Drive Il User s Manual Environmental Conditions Operation Transportation Storage Temperature 40 C 60 C 40 C 104 F 140 F 104 F 10 C 29 C 107C 50 F 20 F 50 F Relative humidity 90 90 90 wt i wi 10 10 10 Atmospheric pressure 1060 hPa 1060 hPa 1060 hPa 500 hPa 500 hPa 500 hPa Altitude max 5000 m max 5000 m Caution The machine must not be stored or operated in explosive atmospheres Small Battery Drive Il User s Manual Synthes 47 System Specifications Duty Cycle i Intermittent operation X on Y off Cycles Drilling and tapping threads and reaming 60 sec 60 sec 9 Burring 60sec 60sec 3 Kirschner Wire setting 30sec 60 sec 6 Sawing 532 021 30 sec 60 sec 5 532 023 15sec 60sec 4 532 026 30sec 60sec 4 Other attachments 60sec 60sec 7 Generally electrical systems can heat up if in constant use For this reason the handpiece and the attachment should be allowed to cool for at least 60 seconds Y following the time of constant use X After a certain amount of cycles defined in the above table under Cycles the handpiece and attachment should b
45. s Manual Synthes 25 Attachments Large Oscillating Saw Attachment 532 026 The Large Oscillating Saw Attachment is a specially designed saw attachment for performing a crescentic saw cut e g while performing a Tibial Plateau Leveling Osteotomy in the canine proximal tibia The attachment is approved for use in both humans and animals Inserting the saw blade Insert the saw blade in the saw blade coupling and tighten the screw in the saw blade with the key 532 027 that was delivered with the attachment or use a T15 StarDrive screwdriver e g 314 115 Check that the saw blade is correctly in place and properly tightened Mounting the saw attachment Make sure that the mode switch of the handpiece is in the OFF position and that the locking sleeve on the saw attachment is set to the unlock position amp Insert the saw attachment in any position into the attachment coupling of the handpiece until it locks into place To prevent vibrations during operation and to increase the sawing capacity additional manual tightening of the attachment onto the handpiece is required Turn the locking sleeve into the lock direction until you feel that the coupling pins engage into the handpiece approx half a revolution Precautions Set the mode switch of the Small Battery Drive II to the ON position Never operate the Large Oscillating Saw attachment in the oscillating drilling mode Q Avoid applying high press
46. s correctly inserted when the marking M on the burr shank is no longer visible If using an L sized burr the L marking on the burr shank will remain visible Pull lightly on the burr to confirm that it is secure Information on handling burrs Synthes recommends using a new sterile burr for each operation This prevents health risks to the patient Used burrs present the following risks Necrosis due to excess heat Longer cutting time due to reduced performance of the burr Precautions Burrs must be cooled with irrigation liquid to prevent heat necrosis The attachments may only be used with the burrs intended for this purpose or one size above attachment is size M please therefore only use burrs of size M or L Synthes recommends wearing protective goggles when working with burrs 22 Synthes Small Battery Drive Il User s Manual Saw Attachments Precaution Even if lines and measurements are indicated on the saws these articles should not be used as measuring instruments Oscillating Saw Attachment 532 021 Positioning the saw attachment The attachment can be locked in eight different positions 45 steps when coupled Lock the machine push the sliding sleeve N toward the saw blade coupling and rotate the attachment into the desired position Fig 1 Precaution To prevent injury always grip the saw attachment with the inserted saw blade from the direction of the machine
47. stic purposes Voltage tluctuations Not applicable flicker emissions IEC 61000 3 3 Small Battery Drive Il User s Manual Synthes 51 Electromagnetic Compatibility Table 2 Immunity all devices Guidance and manufacturer s declaration electromagnetic immunity The Synthes Small Battery Drive Il system is intended for use in the electromagnetic environment specified below The customer or user of the Synthes Small Battery Drive Il system should ensure that it is used in such an environment Immunity test IEC 60601 Compliance Electromagnetic environment guidance standard test level level Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile discharge ESD 8 kV air 8 kV air If the floors are covered with synthetic material IEC 61000 4 2 the relative humidity should be at least 30 Electrical fast 2 kV for power Not applicable Electrical power quality should be that of a typical transient burst supply lines commercial or hospital environment IEC 61000 4 4 Surge 1 kV line to line Not applicable Electrical power quality should be that of a typical IEC 61000 4 5 commercial or hospital environment 2 kV line to earth Voltage dips short interrup lt 5 U Not applicable Electrical power quality should be that of a typical tions and voltage variations 0 5 cycle commercial or hospital environment on power supply lines IEC 61000 4 11 40 U 5 cycles 70 U
48. t lies central to the three jaws Tighten the drill chuck with the key Make sure that the teeth of the key engage correctly in the toothed rim of the chuck Removing cutting tools Open the Chuck with the key and remove the tool Precautions Do not use the Small Battery Drive Il for acetabular reaming Check the cutting tool for wear and or damage after each use and replace if necessary To ensure good fixation of the tools make sure the toothed rims on the drill chuck and key are not worn 14 Synthes Small Battery Drive Il User s Manual Screw Attachments Screw Attachment with AO Quick Coupling 05 001 251 Mounting and removing the tools Insert the tool into the attachment from the front by applying slight pressure and turning slightly It is not necessary to operate the coupling sleeve of the attachment To disconnect push the coupling sleeve of the attachment back and remove the tool Precautions Care should be taken when inserting screws with the drive unit Never fully insert screws with the drive unit The final turns or locking should always be done manually Always use an appropriate torque limiting attachment when putting locking screws into a locking plate Theoretically it is also possible to use the AO Quick Coupling 05 001 250 to insert screws However the Screw Attachment 05 001 251 has a lower speed and a higher torque and is therefore more suitable Screws with a
49. ted with the light adapter 05 001 108 connected to one of the electrical consoles belonging to the Electric Pen Drive 05 001 000 or 05 001 002 When the Small Battery Drive Il is operated electrically it is classified as type B against electrical shock and leakage current The adapter can be inserted into the Small Battery Drive Il handpiece and removed like a battery pack see Fig 13 and 14 Also follow the Electric Pen Drive User s Manual J6374 Figure 13 Figure 14 Small Battery Drive II User s Manual Synthes i Attachments General Information The Small Battery Drive Il system offers a broad range of attachments A wide range of rotating attachments has color coded rings so that they can easily be identified The table on the next page lists the different types of attachments available the color coding as well as the speed of each attachment Mounting the attachments Insert the attachment into the attachment coupling Fig 1 If the positioning pins do not lock into place right away twist the attachment slightly to the right or left until it locks into the correct position Check if the attachment Is seated correctly by gently pulling on it Removing the attachments Press the attachment release buttons 6 see figure on page 6 simultaneously and remove the attachment from the coupling Precautions To prevent injury the power tool must be switched off with the safety system see
50. the temperature and time are not specified follow Synthes recommendations Devices should be cleaned in a fresh newly made solution Detergents used on the products will be in contact with the following materials stainless steel aluminum plastic and rubber seals Synthes recommends using new sterile cutting tools for each operation Unusual Transmissible Pathogens Surgical patients identified as at risk for Creutzfeldt Jakob disease CJD and related infections should be treated with single use instruments Dispose of the instruments used or suspected of use on a patient with CJD after surgery and or follow the current national recommendations Important The clinical processing instructions provided have been validated by Synthes for preparing a non sterile Synthes medical device these instructions are provided in accordance with ISO 17664 2004 and ANSI AAMI ST81 2004 Consult the national regulations and guidelines for additional intormation In addition compliance with internal hospital policies and the procedures and recommendations of manufacturers of detergents disinfectants and any clinical processing equipment is additionally required It remains the responsibility of the processor to ensure that the processing performed achieves the desired result using the appropriate properly installed maintained and validated equipment materials and personnel in the processing unit Any deviation by th
51. the respective directive The tool may not be disposed of with household waste Small Battery Drive II User s Manual Synthes 43 Troubleshooting Problem Possible causes Solution Handpiece does not start up Battery is dead Charge the battery or replace it with a charged battery The tool was not cooled off after sterilization Let the tool cool to room temperature Mode selector switch is on OFF Turn the mode selector switch to ON or Q No contact between the handpiece and the battery pack Reinsert the battery pack or replace it Handpiece does not have enough power Battery is dead Charge the battery or replace it with a charged battery Machine stops suddenly The machine has overheated overheating protection is activated Wait until the machine has cooled down Battery is dead Charge the battery or replace it with a charged battery Attachments cannot be coupled to the unit The attachment coupling is blocked by deposits Remove solid objects with a pair of tweezers Precaution When removing objects turn the mode selector switch to OFF Tool saw blade drill burr etc cannot be coupled or only with difficulty Shaft geometry of the attachment or tool is damaged Replace the attachment or tool or send it to your Synthes service office Oscillating saw attachment vibrates too much The saw blade locking mech
52. trols for smooth operation and function Check the coupling sleeves of the handpiece and attachments for smooth operation and check for function together with instruments such as cutting tools Check instruments for correct adjustment and functioning prior to every use Small Battery Drive II User s Manual Synthes 39 Care and Maintenance Packaging Sterilization and Storage Packaging Put cleaned dry products into the proper places in the Synthes case or washing basket Additionally use an appropriate sterilization wrap or reusable rigid container system for sterilization such as a Sterile Barrier System according to ISO 11607 Care should be taken in order to protect implants as well as pointed or sharp instruments trom contact with other objects that may damage the surface or the Sterile Barrier System Sterilization Synthes Small Battery Drive Il system may be resterilized using validated steam sterilization methods ISO 17665 or national standards Synthes recommendations for packed devices and cases are as follows Cycle type Sterilization exposure Sterilization exposure Drying time time temperature Saturated steam forced air Minimum 4 minutes Minimum 132 C 20 60 minutes removal pre vacuum Wrapped or unwrapped Maximum 138 C Minimum 3 minutes Minimum 134 C 20 60 minutes Wrapped or unwrapped Maximum 138 C Drying times generally range from 20 to 60 minutes due to differen
53. ure onto the saw blade Removing the saw attachment Turn the locking sleeve to the unlock position before pushing both release buttons on the handpiece 26 Synthes Small Battery Drive Il User s Manual Other Attachments Torque Limiter 1 5 Nm 511 773 Torque Limiter 0 8 Nm 511 776 Torque Limiter 0 4 Nm 511 777 Coupling the Torque Limiter to the power tool Torque Limiters are connected to the Small Battery Drive ll using the AO Quick Coupling 05 001 251 Mounting and removing a screwdriver shaft Insert the screwdriver shaft while rotating it slightly until it locks into place To remove it pull back the unlocking ring and pull out the screwdriver shaft Using the Torque Limiter Pick up a screw from the corresponding LCP system Locking Compression Plate with the screwdriver shaft and insert it in the desired plate hole To insert the screw start the power tool slowly increase the speed and then reduce it again before the screw is fully tightened The torque Is automatically limited to 1 5 0 8 or 0 4 Nm When this limit is reached you will hear a distinct clicking Stop the tool immediately and pull the tool away from the screw Follow the surgical technique of the respective LCP system Precaution The Torque Limiter must be annually serviced and recalibrated by Synthes Note the information on the test certificate in the packaging The user is responsible for following the calibration schedule
54. ure to insert the Kirschner Wire trom the front into the cannulation J The wire is held automatically 3 Adjust the working length by pulling on the wire 4 To affix the wire pull the tension lever L against the tool with your little finger and ring finger Only pull the tension lever against the tool as much as necessary The clamping force can be varied by pulling and releasing the clamping lever 5 Insert the wire into the bone Apply the clamping force as long as the wire is advanced 6 To adjust the grip on the wire reduce the clamping force and move the tool to the desired length Reclamp the wire by pulling on the tension lever 18 Synthes Small Battery Drive Il User s Manual Radiolucent Drive 511 30 The Radiolucent Drive can be used with the Small Battery Drive Il in combination with the AO Quick Coupling 05 001 250 and the Adapter for the Radiolucent Drive 532 031 Coupling the Radiolucent Drive to the power tool Connect the AO Quick Coupling to the Small Battery Drive Il 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 position Support the drive with your free hand Inserting the drill bit Pull the ring on the attachment forward and position the drill bit inside the coupling as far as it can go while rotating it slightly Engage the ring on the attachment back in order to t
55. user of the product is responsible for proper use of the equipment during surgery If the Small Battery Drive Il is used in conjunction with an implant system make sure to consult the corresponding Technique Guide For important information regarding electromagnetic compatibility EMC please refer to the chapter Electromagnetic Compatibility in this manual The tool is classified as type BF against electrical shock and leakage current The tool is suitable for use on patients in accordance with IEC 60601 1 To ensure the proper operation of the tool Synthes recommends annual maintenance by a Synthes service center The manufacturer shall assume no responsibility for damage resulting from improper operation neglected or unauthorized maintenance of the tool Precautions To avoid injuries the locking mechanism of the tool has to be activated before every manipulation and before placing the tool back down i e the mode switch has to be in the OFF position The tool may only be operated with a fully charged battery To do this ensure that the battery is charged prior to use We recommend that the battery is replaced into the charger immediately after surgery The batteries may never be sterilized This would destroy the battery with possible secondary damage Should the machine fall and have visible detects discontinue use and send it to the Synthes service center Small Battery Drive Il Us
56. y normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Synthes Small Battery Drive Il system A Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Small Battery Drive II User s Manual Synthes 53 Electromagnetic Compatibility Table 4 Recommended separation distances Recommended separation distances between portable and mobile RF communications equipment and the Synthes Small Battery Drive Il system The Synthes Small Battery Drive II system is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Synthes Small Battery Drive Il system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Synthes Small Battery Drive Il system as recommended below according to the maximum output power of the communication equipment Rated maximum output Separation distance according to frequency of transmitter power of transmitter W m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 0 35 VP d 0 35 VP d 0 35 VP 0 01 4 cm 4 cm 4 cm 0 1 11 cm 11 cm 44 cm 1 35 cm 35 cm 1 4m 10 Ss i a 1 11 m 4 4m 100 3 5m ZIM 14 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in met
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