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Instructions for Use

Surgical

Contra-angle handpieces

WS-56 L, WS-75 L, WS-91 L, WS-92 L

with mini LED+

Содержание SURGICAL WS-56 L

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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