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W&H SURGICAL WS-56 L, Instructions For Use Manual

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W&H SURGICAL WS-56 L Instructions For Use Manual Download Page 2

2

Symbols

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4

in the Instructions for Use ...................................................................................................................................................................4
on the medical device / packaging ......................................................................................................................................................5

1. Introduction

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6

2. Safety notes

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9

3. Product description

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13

4. Operation

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15

Assembly/Removal ............................................................................................................................................................................15
Rotary instruments ............................................................................................................................................................................19
To change the rotary instrument ...................................................................................................................................................... 20
Test run .............................................................................................................................................................................................. 24

5. Hygiene and maintenance

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25

General notes..................................................................................................................................................................................... 25
Limitations on processing ................................................................................................................................................................ 27

Contents

Summary of Contents for SURGICAL WS-56 L

Page 1: ...Instructions for Use Surgical Contra angle handpieces WS 56 L WS 75 L WS 91 L WS 92 L with mini LED...

Page 2: ...ce packaging 5 1 Introduction 6 2 Safety notes 9 3 Product description 13 4 Operation 15 Assembly Removal 15 Rotary instruments 19 To change the rotary instrument 20 Test run 24 5 Hygiene and maintena...

Page 3: ...5 Automated cleaning and disinfection 36 Drying 38 Inspection Maintenance and Testing 39 Packaging 44 Sterilization 45 Storage 48 6 Servicing 49 7 W H Accessories and spare parts 50 8 Technical data 5...

Page 4: ...G if persons could be injured Caution Federal law restricts this device to sale by or on the order of a dentist physician veterinarian or with the descriptive designation of any other practitioner lic...

Page 5: ...arking with identification number of the Notified Body UL Component Recognition Mark indicates compliance with Canadian and U S requirements DataMatrix Code for product information including UDI Uniqu...

Page 6: ...standards For your safety and the safety of your patients Prior to initial use please read the Instructions for Use These explain how to use your medical device and guarantee a smooth and efficient o...

Page 7: ...of the manufacturer The manufacturer can only accept responsibility for the safety reliability and performance of the medical device when it is used in compliance with the following directions The med...

Page 8: ...ould be prepared for use and maintained by staff who have been trained in procedures for infection control personal safety and patient safety Improper use e g through poor hygiene and maintenance non...

Page 9: ...ensure adequate suction In case of coolant supply failure the medical device must be stopped immediately Check the medical device for damage and loose parts each time before using e g push button Do n...

Page 10: ...o the push button heating up Avoid contact between LED and soft tissue risk of burning due to the LED heating up Do not use the medical device as a light probe Do not look directly into the LED The me...

Page 11: ...elds Find out if patient and user have implanted systems before using the medical device and consider the application Weigh the risks and benefits Keep the medical device away from implanted systems M...

Page 12: ...in PE film and not sterilized when delivered The PE film and the packaging are non sterilizable Clean disinfect and lubricate the medical device Sterilize the medical device the nozzle cleaner the Y m...

Page 13: ...13 WS 56 L WS 75 L WS 91 L WS 92 L LED Push button Contra angle head Middle gear Knee Sheath Symbols on parts and Sheath open Direction of rotation Sheath locked 3 Product description...

Page 14: ...ng system Y manifold WS 91 L WS 92 L External coolant tube Spray nozzles WS 56 L WS 75 L Spray clips for the left and right WS 56 L WS 75 L WS 91 L WS 92 L Nozzle cleaner Kirschner Meyer internal bur...

Page 15: ...You can only make full use of all the medical device s advantages in this combination e g constant illumination at every speed The medical device may only be used with W H electric motor EM 19 LC EM...

Page 16: ...WS 75 L Spray clip Coolant tube for internal bur cooling system Attach the spray clip Insert the coolant tube for internal bur cooling system or Remove the coolant tube for internal bur cooling system...

Page 17: ...17 Medical device Push the medical device onto the motor and turn until it engages audibly Verify secure hold or Remove the medical device...

Page 18: ...tube for internal bur cooling system Insert the coolant hose of the Y manifold onto the coolant tube of the spray clip and onto the coolant tube for internal bur cooling system Insert the Y manifold i...

Page 19: ...the rotary instrument only when the medical device is stationary Never touch the rotary instrument while it is still rotating Do not activate the push button of the medical device during operation Thi...

Page 20: ...nstrument WS 56 L Instrument shaft diameter 2 35 mm Insert the rotary instrument until the limit stop Turn the rotary instrument until it engages Verify secure hold or Activate the push button and rem...

Page 21: ...nt shaft diameter 1 6 mm Insert the rotary instrument Activate the push button at the same time insert the rotary instrument until the limit stop a Verify secure hold or Activate the push button and r...

Page 22: ...Instrument shaft diameter 2 35 mm Insert the coolant tube for internal bur cooling system or Remove the coolant tube for internal bur cooling system Insert the rotary instrument over the coolant tube...

Page 23: ...23 Verify secure hold or Activate the push button and remove the rotary instrument Ask your implant supplier for an applicable rotary instrument with hexagon...

Page 24: ...level Insert the rotary instrument Operate the medical device In the event of operating malfunctions e g vibrations unusual noise overheating coolant failure or leaking stop the medical device immedia...

Page 25: ...nd guidelines for cleaning disinfection and sterilization Wear protective clothing safety glasses face mask and gloves Use only oil free filtered compressed air with a maximum operating pressure of 3...

Page 26: ...mes specified by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by the Verbund f r Angewandte Hygiene e V VAH Association for Applied Hygiene the ste...

Page 27: ...vices and or medical devices with material changes to an authorized W H service partner Processing cycles We recommend a regular service for the W H medical device after 500 processing cycles or one y...

Page 28: ...10 seconds at idle speed Ensure that all coolant outlets are rinsed out Wipe the entire surface of the instrument with disinfectant Remove the rotary instrument Remove the medical device Note that the...

Page 29: ...ing system Remove the spray clip Hold the contra angle head firmly with one hand Press sheath gently against knee At the same time twist the sheath off the knee Remove the knee from the contra angle h...

Page 30: ...disinfectant or in an ultrasonic bath Clean the medical device under running tap water 35 C 95 F Rinse and brush off all internal and external surfaces Move moving parts back and forth several times...

Page 31: ...g the spray nozzles The coolant tube for internal bur cooling system the spray clips and the nozzle cleaner can be cleaned in an ultrasonic bath and or in the washer disinfector Clean coolant outlets...

Page 32: ...32 Blow through the coolant tube and coolant outlets using compressed air In case of blocked coolant outlets or coolant tubes contact an authorized W H service partner...

Page 33: ...3 WS 75 L Cleaning the Y manifold The Y manifold can be cleaned in an ultrasonic bath and or in the washer disinfector Rinse with running tap water 35 C 95 F Remove liquid residues using compressed ai...

Page 34: ...cleaning fluid and a soft cloth Blow the LED dry using compressed air or dry it carefully with a soft cloth Carry out a visual inspection after each cleaning process Do not use the medical device if t...

Page 35: ...f the medical device s basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants mikrozid AF wipes Sch lke Mayr GmbH Norderstedt and Ca...

Page 36: ...tants Evidence of the medical device s basic suitability for effective automated disinfection was provided by an independent test laboratory using the Miele PG 8582 CD washer disinfector Miele Cie KG...

Page 37: ...00 Screw the W H adaptor into the adaptor on the injector rail Screw the W H intermediate adaptor onto the W H adaptor Put the W H silicone hose over the W H intermediate adaptor Insert the external c...

Page 38: ...38 Ensure that the medical device is completely dry internally and externally after cleaning and disinfection Remove liquid residues using compressed air Hygiene and maintenance Drying...

Page 39: ...fection for damage visible residual soiling and surface changes Reprocess any medical devices that are still soiled Sterilize the reassembled medical device following cleaning disinfection and lubrica...

Page 40: ...infection Without spray clip Type and serial numbers must be identical Insert the middle gear into the knee Insert the knee into the contra angle head Check free running of the chucking system a and s...

Page 41: ...nfection Recommended lubrication cycles Essential after every internal cleaning Before each sterilization With W H Service Oil F1 MD 400 Follow the instructions on the oil spray can and on the packagi...

Page 42: ...e spray adaptor REF 02036100 onto the oil spray can Hold the medical device firmly Press the tip of the spray adaptor firmly into the chucking system Spray for approximately 1 second or With W H Assis...

Page 43: ...Test after lubrication Direct the medical device downwards Operate the medical device so that excess oil can escape Remove any oil that has escaped Excess oil may result in the medical device overheat...

Page 44: ...he sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization procedure The sterilization package must be large enough for the st...

Page 45: ...e instructions and heed the warnings provided by the manufacturers of steam sterilizers The program selected must be suitable for the medical device Pull off the spray clip from the medical device bef...

Page 46: ...dures Dynamic air removal prevacuum cycle type B 134 C 273 F for at least 3 minutes 132 C 270 F for at least 4 minutes Gravity displacement cycle type N 121 C 250 F for at least 30 minutes Maximum ste...

Page 47: ...the CertoClav MultiControl MC2 S09S273 steam sterilizer CertoClav GmbH Traun Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes 132 C 270 F 4 minutes Gravity displacement cycle type N 12...

Page 48: ...48 Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging Hygiene and maintenance Storage...

Page 49: ...malfunctions immediately contact an authorized W H service partner Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has been com...

Page 50: ...0940021 Service Oil F1 MD 400 6 pcs 02038200 Spray adaptor 02036100 Spray adaptor for chucking system 02015101 Nozzle cleaner 07233500 Adaptor kit for the washer disinfector Use only original W H acce...

Page 51: ...0 Spray clip for the left 3 pcs Kirschner Meyer internal bur cooling system Without internal bur cooling system 06948300 06949500 Spray clip for the right 3 pcs Kirschner Meyer internal bur cooling sy...

Page 52: ...ission ratio 20 1 Colour coding green Permitted motor connection W H EM 19 LC EM 19 Rotary instruments Maximum permitted bur length Minimum chucking length ISO 1797 mm mm 2 35 45 engaging Maximum driv...

Page 53: ...ties WS 56 L WS 91 L WS 92 L Transmission ratio 1 1 1 2 7 Colour coding blue orange Permitted motor connection W H EM 19 LC EM 19 Rotary instruments Maximum permitted bur length Minimum chucking lengt...

Page 54: ...50 C 122 F Temperature of the working part rotary instrument maximum 41 C 105 8 F Ambient conditions Temperature during storage and transport 40 C to 70 C 40 F to 158 F Air Humidity during storage an...

Page 55: ...Ensure that the parts are not contaminated on disposal Follow your local and national laws directives standards and guidelines for disposal Medical device Waste electrical equipment Packaging 9 Dispos...

Page 56: ...cts within a warranty period of 24 months from the date of purchase Accessories and consumables coolant tube spray clips nozzle cleaner spray adaptor adaptor kit are excluded from the warranty We acce...

Page 57: ...57 Find your nearest authorized W H service partner at http wh com Simply go to the menu option Service for full details Or simply scan the QR code Authorized W H service partners...

Page 58: ...Manufacturer Form Nr 50885 AEN Rev 003 27 01 2021 Subject to alterations W H Dentalwerk B rmoos GmbH Ignaz Glaser Stra e 53 5111 B rmoos Austria t 43 6274 6236 0 f 43 6274 6236 55 office wh com wh com...

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