Synthes Air Power Line II Instructions For Use Manual Download Page 4

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DePuy Synthes

Air Power Line II Instructions for Use

Care and Maintenance

General Information

Preparation prior to Cleaning

Manual Cleaning Instructions

Automated Cleaning Instructions with

Manual Pre-cleaning

Maintenance and Lubrication

Inspection and Function Test

Packaging, Sterilization and Storage

Repairs and Technical Service

Disposal of Waste

Troubleshooting

System Specifications

Ordering Information

Contents

Summary of Contents for Air Power Line II

Page 1: ...TIONS FOR USE Air driven power tool system for orthopedics and traumatology AIR POWER LINE II Instruments and implants approved by the AO Foundation This publication is not intended for distribution in the USA ...

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Page 3: ...er Line system 6 Working with the Air Power Line system 7 Air Reamer Drill II Power Tool 8 Attachments for the Air Reamer Drill II 9 Air Oscillator Power Tool 18 Attaching the Saw Blades 19 Positioning the Saw Head 20 Air Reciprocator Power Tool 21 Attaching the Saw Blades 22 Positioning the Saw Head 23 Contents ...

Page 4: ...g 26 Manual Cleaning Instructions 27 Automated Cleaning Instructions with 29 Manual Pre cleaning Maintenance and Lubrication 33 Inspection and Function Test 35 Packaging Sterilization and Storage 36 Repairs and Technical Service 38 Disposal of Waste 39 Troubleshooting 40 System Specifications 42 Ordering Information 46 Contents ...

Page 5: ...system to be used for treatment in orthopedic and traumatology sur gery i e drilling reaming cutting placing of Kirschner Wires on bone of human skeleton Safety Instructions The surgeon has to evaluate if the machine is suitable for an application based on power limitation of the machine at tachment and cutting tool regarding bone strength anatomi cal situation as well as handling of the machine a...

Page 6: ...em To reach the specified performance only Synthes cutting tools should be used These are optimized to meet the spe cific requirements of the tool Non Synthes saw blades can considerably reduce the lifetime of the system Special auxiliaries such as cleaning brushes 516 101 and Synthes Special Oil 519 970 are available for cleaning and servicing the system No oils from other manufacturers may be us...

Page 7: ...nt to another This could result in the injury or death of the patient or user Synthes does not recommend reprocessing con taminated 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 undam aged the products may have small defects and internal ...

Page 8: ...might lead to bursting of the outer hose Connecting the compressed air hose to the handpiece Attach the hose coupling over the air inlet nipple on the unit up to the stop The coupling will lock by itself with an audible click Attach the other end of the air hose to the compressed air or nitrogen source Ensure that the coupling geometry of the air hose is compatible with the geometry of the wall co...

Page 9: ...unintentional operation To lock the trigger pull it forward according to the marking on the handle and then turn it To unlock the trigger twist it in the opposite direction and then push it back Operating the trigger The trigger smoothly regulates the speed of the Air Reamer Drill II 511 606 and the frequency of the Air Oscillator 511 610 and the Air Reciprocator 511 615 ...

Page 10: ...ir Reamer Drill is equipped with a knob for forward and backward 5 By turning the knob in the indicated direction the tool switches from forward to reverse or vice versa Caution Do not switch the direction of rotation while the tool is operating Use reverse only with tools that are approved for such use Otherwise the tool may break and cause damage Technical data Rpm without attachment 0 340 rpm W...

Page 11: ...Only use original attachments and tools from Synthes Damage that might arise from using attachments and tools of other manufacturers is not covered by the war ranty Properly functioning attachments are essential to the success of an operation For this reason used attachments must be checked for wear and or damage after each use and replaced if necessary Precaution During reaming procedure high tor...

Page 12: ...ailable in two different speeds for drilling and reaming respectively The attach ments are marked accordingly Figs 1 and 2 Drill attachments Blue color marking and inscribed with DRILL All drilling speed attachments are geared to increase the maximum drive speed to 930 rpm while reducing the maxi mum torque to 8 0 Nm Ream attachments Red color marking and inscribed with REAM All reaming speed atta...

Page 13: ...Quick Coupling 530 794 Speed 0 930 rpm Quick Coupling for DHS DCS Triple Reamers 530 760 Speed 0 930 rpm AO ASIF Quick Coupling for Reamer 530 780 Speed 0 340 rpm Hudson Quick Coupling 530 782 Speed 0 340 rpm Trinkle Quick Coupling 530 784 Speed 0 340 rpm Hudson Quick Coupling 530 792 Speed 0 930 rpm Trinkle Quick Coupling modified 530 783 Speed 0 340 rpm Trinkle Quick Coupling modified 530 793 Sp...

Page 14: ...e release the un locking sleeve Turn slightly to ensure that the tool is properly locked into the coupling For the AO ASIF Quick Coupling 530 750 530 780 the tool can be inserted without moving the unlocking sleeve click in Removing cutting tools Pull the unlocking sleeve on the attachment backwards forwards for the DHS DCS Quick Coupling 530 760 and remove the tool Caution Properly operating tool...

Page 15: ...front or back into the cannulation 1 The guide pin is held automatically 3 Adjust the working length by pulling on the guide pin 4 To fit the guide pin pull the tension lever 2 against the tool 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 guide pin into the bone Apply the clamping force a...

Page 16: ...order Ensure that the shaft of the tool is fitted between the centre of the three clamps of the chuck Turn the key clockwise to tighten The teeth of the key must be properly seated in the gear of the drill chuck The teeth of the chuck and of the key must not be worn Drill Chuck keyless 530 731 Open the clamps manually be holding the retaining ring and turning the securing ring clockwise Insert the...

Page 17: ...n of the instrument make sure the toothed rims on the drill chuck and key are not worn Replace damaged or worn components Only use original Synthes key Removing cutting tools Drill Chuck with key 530 730 530 732 Release the chuck by turning the key 510 190 anticlockwise and remove the tool The teeth of the chuck and of the key must not be worn Universal Drill Chuck Keyless 530 731 Hold the Drill C...

Page 18: ...seated correctly by gently pulling on it For removal follow the same procedure in reverse Coupling the Radiolucent Drive to the power tool Attach the Adapter for Radiolucent Drive 530 741 to the Air Reamer Drill II for information please refer to page 9 Mounting the attachments Push the Radiolucent Drive as far as it will go over the quick coupling and the adapter and rotate it into the desired wo...

Page 19: ...arly if the power tool is held face down Only special 3 flute spiral drill bits can be used Your Synthes representative will pro vide 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 appear in the rear of the Radi...

Page 20: ...ob for the saw blade quick coupling 2 Sliding sleeve for positioning the saw head 3 Trigger and safety device 4 Air inlet Technical data Continuously adjustable frequency 0 14000 1 min Weight 1 260 g Air consumption at 6 bar max 380 l min Recommended operating pressure 6 7 bar max 10 bar Saw blade deflection 4 5 Air Oscillator ...

Page 21: ...ick coupling for saw blades by turning the lock ing knob 1 Fig page 18 counter clockwise Use a slight amount of pressure to slide the saw blade against the screw head and turn it to the desired position Lock the saw blade coupling by tightening the locking knob clockwise Removing the saw blade Open the quick coupling for saw blades by turning the locking knob 1 Fig page 18 counter clockwise and re...

Page 22: ...lowing risks are associated with used saw blades Thermal necrosis caused by excessive heat build up Infection caused by residues Extended cutting time due to poor sawing performance Potentially splintering of the teeth or the saw blade The use of irrigation fluid is recommended to cool the cut ting tools and prevent heat necrosis Check the cutting tools for wear and or damage after each use and re...

Page 23: ...ol Air Reciprocator 1 Click in saw blade coupling 2 Sliding sleeve for positioning the saw blade 3 Trigger and safety device 4 Air inlet Technical data Continuously adjustable frequency 0 14000 1 min Weight 1 060 g Air consumption at 6 bar max 380 l min Recommended operating pressure 6 7 bar max 10 bar Stroke 4mm ...

Page 24: ...e bone Mounting the saw blades Insert the saw blade into the guide slot of the saw blade coupling until the lock knob springs back into locked posi tion with a click Check the correct seating of the saw blade by pulling it slightly forward in an axial direction Removing the saw blade Turn the lock knob in the direction of the arrow until the saw blade jumps forward approx 1mm Remove the saw blade ...

Page 25: ...risks are associated with used saw blades Thermal necrosis caused by excessive heat build up Infection caused by residues Extended cutting time due to poor sawing performance Potentially splintering of the teeth or the saw blade The use of irrigation fluid is recommended to cool the cut ting tools and prevent heat necrosis Check the cutting tools for wear and or damage after each use and replace i...

Page 26: ...e in contact with the following materials stainless steel aluminum plastic and rubber seals Never immerse the handpiece or attachments in aqueous solutions or in an ultrasonic bath Do not use pressurized water as this will cause damage to the system Synthes recommends using new sterile cutting tools for each operation Refer to Clinical Processing of Cutting Tools 036 000 499 for detailed clinical ...

Page 27: ...rmore compliance with internal hospi tal policies and procedures and recommendations of man ufacturers of detergents disinfectants and any clinical processing equipment is additionally required Cleaning Agent Information Synthes used the following cleaning agents during validation of these reprocessing recommendations These cleaning agents are not listed in preference to other available cleaning a...

Page 28: ... automated cleaning with manual pre cleaning Article number Procedure Air Power Line II handpieces Put the seal nipple 519 596 on the machine s air inlet 511 606 511 610 511 615 Synthes Double Air Hoses Seal the Synthes Double Air Hose by joining the inlet and outlet 519 510 519 530 519 550 Dräger Double Air Hoses Connect both sides of the Dräger Double Air Hose with the seal nipple 519 596 519 61...

Page 29: ...tion 3 Spray and wipe Brushes shall be inspected before daily use and discarded if they have degraded to the point where they may scratch instrument surfaces or be ineffective due to worn or missing bristles Make sure that no cleaning solution enters the machine s air inlet Never immerse the handpiece or attachments in aqueous solutions or in an ultrasonic bath Do not use pressurized water as this...

Page 30: ...er 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 or pipette 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 sliding sleeves attachment release r...

Page 31: ...606 511 610 511 615 Synthes Double Air Hoses Seal the Synthes Double Air Hose by joining the inlet and outlet 519 510 519 530 519 550 Dräger Double Air Hoses Connect both sides of the Dräger Double Air Hose with the seal nipple 519 596 519 610 519 630 519 650 BOC Schrader Double Air Hoses Connect both sides of the BOC Schrader Air Hose with the seal nipple 519 591 or 519 592 519 511 519 531 Note B...

Page 32: ...ld be used Precautions Do not use pointed objects for cleaning Brushes and other cleaning tools shall be either single use items or if reusable be decontaminated at least daily us ing a solution as detailed on page 31 in section 3 Spray and wipe Brushes shall be inspected before daily use and discarded if they have degraded to the point where they may scratch instrument surfaces or be ineffective ...

Page 33: ... and or soft lint free cloth to remove all visible soil and debris Follow the enzymatic cleaner or deter gent manufacturer s instructions for use for correct tempera ture 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 or pipette to flush lumens and channels Actuate joints hand...

Page 34: ...tion processing 90 C Dry 40 minutes 90 C 9 Inspect device Remove all devices from the washing tray Remove the seal nipple on the machine s air inlet and from the Double Air Hose inspect the cannulations sliding sleeves etc for visible soil If necessary repeat the manual pre cleaning automated cleaning cycle Confirm that all parts are completely dry Precaution Mechanical cleaning is an additional s...

Page 35: ...g the power tools After each use apply around 5 drops of the Synthes special oil oil dispenser 519 970 into the air inlet of the cleaned power tool Fig 1 Connect the power tool to a double hose using the lubri cation adapter 519 790 Fig 2 Wrap gauze or a cloth around the hose coupling to ab sorb the exiting oil Run the power tool for approximately 20 seconds If dirty oil exits the process must be ...

Page 36: ...nd the APL II Care and Maintenance Poster 038 000 017 Power tools and accessories may only be lubricated with Synthes special oil 519 970 The composition of the vapor permeable and biocompatible oil is optimized for the specific requirements of the power tools Lubricants with other compositions can cause the power tools to jam and be toxic Only lubricate the power tools and attachments when clean ...

Page 37: ...vent the mov able parts from moving smoothly Check the release ring of the handpiece and attachments for smooth operation and check for function together with cut ting tools Check instruments and cuttings tools for correct adjustment and functioning prior to every use Do not use damaged worn or corroded components but send them instead to the Synthes Service Center Failing to follow these instruct...

Page 38: ...Sterile Barrier System Sterilization Synthes Air Power Line II 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 time minutes Sterilization exposure temperature Dry time minutes Saturated steam forced air removal pre vacuum Minimum 4 Minimum 132...

Page 39: ...power tool and could result in harm to the user and patient Hot air ethylene oxide plasma and formaldehyde steriliza tion are not recommended Ensure that the seal nipple 519 596 is removed from the machine s air inlet and that the air hose s inlet and outlet are disconnected prior to sterilization Storage Storage conditions for products labeled STERILE are printed on the packaging label Packaged a...

Page 40: ...longer available please contact the Synthes affiliate This system requires regular maintenance service at least once a year in order to maintain its functionality This service has to be performed by the original manufacturer or an au thorized site 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 section Dispos...

Page 41: ...ensures that they are disposed of in accordance with the national application of the respec tive directive The device may not be disposed of with house hold waste To prevent damage during shipping use the original packag ing to return devices back to Synthes If this is not possible please contact the Synthes affiliate Precaution Contaminated products have to run through the complete reprocessing p...

Page 42: ...Check wall and power tool hose couplings for leaks Central air system is blocked Have someone check the central air system Power tool continues to operate after releasing the trigger The trigger is blocked by deposits of blood etc Press trigger several times clean and oil according to instructions Use only Synthes Special Oil Oil Dispenser 519 970 Trigger is blocked Safety system is activated Unlo...

Page 43: ...s with a tweezer Do not use sharp ob jects for this If necessary clean and oil the power tool and move the moving parts a few times Tool cannot be coupled Coupling geometry of the tool has changed due to wear Exchange the tool or send it to your local Synthes Service Center Bone and tool heat up during surgery The tool blades are blunt Replace the tool Oscillating saw vibrates too much The saw bla...

Page 44: ...0 F 6h 30 products have been tested according to ISTA 2A Precaution The machine must not be stored or operated in explosive atmospheres Operation Storage Temperature 40 C 104 F 10 C 50 F 40 C 104 F 10 C 50 F Relative humidity 90 30 90 30 Atmospheric pressure 1060 hPa 1 06 bar 700 hPa 0 7 bar 1060 hPa 1 06 bar 700 hPa 0 7 bar Altitude 0 3000m 0 3000m Environmental Conditions ...

Page 45: ...y cycles for each handpiece and attachment listed below Intermittent operation guidelines Xs on Ys off Cycles Drilling and tapping threads 60 sec 60 sec 5 Kirschner wire and pin setting 30 sec 90 sec 5 Reaming 60 sec 60 sec 5 Oscillating sawing 30 sec 90 sec 5 Reciprocating sawing 20 sec 120 sec 5 Generally Power Tools systems heat up if in constant use For this reason the handpiece and the attach...

Page 46: ...e Level LpA in dB A Sound Power Level LwA in dB A Max daily exposure time without hearing protection Air Reamer Drill II 511 606 Drill Ream 78 8 h Air Oscillator II 511 610 Saw Blade 519 115 83 94 8 h Saw Blade 519 170 83 94 8 h Saw Blade 05 002 105 85 96 8 h Air Reciprocator II 511 615 Saw Blade 511 905 83 95 8 h Saw Blade 511 912 85 95 8 h Operation condition Handpiece 511 606 with 530 750 at id...

Page 47: ...6 Drill Ream 2 5 No limitation Air Oscillator II 511 610 Saw Blade 519 115 6 3 5 h Saw Blade 519 170 4 7 No limitation Saw Blade 05 002 105 5 2 7 h 28 min Air Reciprocator II 511 615 Saw Blade 511 905 11 6 1 h 28 min Saw Blade 511 912 11 5 1 h 32 min Operation condition Handpiece 511 606 with 530 750 at idle speed 450 rpm and with 6 bar Handpiece 511 610 at idle speed 14 000 Osc min and with 6 bar...

Page 48: ... Key for Drill Chuck clamping range up to 7 3mm 530 731 Drill Chuck keyless for Power Line 510 790 Quick Coupling for Guide Pins 1 5 to 4 0mm 530 782 Hudson Quick Coupling 340 1 min for Power Line 530 792 Hudson Quick Coupling 930 1 min for Power Line 530 783 Trinkle Quick Coupling 340 1 min modified for Power Line 530 793 Trinkle Quick Coupling 930 1 min modified for Power Line 530 784 Trinkle Qu...

Page 49: ...length 2 m Accessories 516 101 Cleaning brush for APL II BPL TRS 519 970 Oil dispenser with Synthes special oil 519 790 Lubrication adapter for SYNTHES compressed air units 519 591 Seal Nipple for BOC Schrader Double Air Hoses silver 519 592 Seal Nipple for BOC Schrader Double Air Hoses beige 519 596 Seal Nipple for Compact Air Drive and for Dräger Double Air Hoses Can also be used to close the ai...

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Page 52: ...Switzerland Tel 41 61 965 61 11 Fax 41 61 965 66 00 www depuysynthes com This publication is not intended for distribution in the USA DePuy Synthes Power Tools a division of Synthes GmbH 2016 All rights reserved 036 000 136 DSEM PWT 0715 0074 2 04 16 ...

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