W&H piezomed classic Скачать руководство пользователя страница 38 | Manualshive

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8. Technical data

Type B applied part (not suitable for intracardiac application)

SA-40 / SA-40 L

Maximum power consumption

(W)

24

Frequency (ultrasonic)

(kHz)

22-35

Coolant flow rate at 100 %

(ml/min)

at least 50

Operating mode

S3 (80s on/330s off)

maximum 4 repeats

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Содержание piezomed classic

Страница 1: ...Instructions for Use Handpiece with cable SA 40 SA 40 L...

Страница 2: ...3 Description 15 4 Instruments 16 Insert 16 Remove 17 5 Hygiene and maintenance 18 General notes 18 Limitations on processing 20 Initial treatment at the point of use 21 Manual cleaning 22 Automated c...

Страница 3: ...tenance and testing 30 Packaging 32 Sterilization 33 Storage 35 6 Servicing 36 7 W H accessories and spare parts 37 8 Technical data 38 9 Disposal 40 Explanation of warranty terms 41 Authorized W H se...

Страница 4: ...spose of with domestic waste General explanations without risk to persons or objects ATTENTION to prevent damage occurring WARNING risk of injury Symbols in the Instructions for Use Suitable for ultra...

Страница 5: ...trix Code for product information including UDI Unique Device Identification Serial number Data structure in accordance with Health Industry Bar Code Thermo washer disinfectable Sterilizable up to the...

Страница 6: ...Federal law restricts this device to sale by or on the order of a physician dentist veterinarian or with the descriptive designation of any other practitioner licensed by the law of the State in which...

Страница 7: ...ety of your team and of course the safety of your patients are of paramount importance to us Observe the safety notes Intended use Piezoceramic oscillating system for treatment of organic hard and sof...

Страница 8: ...nly accept responsibility for the safety reliability and performance of the medical device when it is used in compliance with the following directions The medical device must be used in accordance wit...

Страница 9: ...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 10: ...ut the medical device into operation when the handpiece sleeve is attached Avoid overheating at the treatment site If the LED fails change the LED socket Only change the LED socket when the handpiece...

Страница 11: ...ment is not changed e g by dropping Instruments must not be bent back to shape or reground Only insert the instrument when the handpiece is at rest Never touch the instrument when vibrating Remove the...

Страница 12: ...ithout coolant Coolant supply The medical device is designed for use with physiological saline solution Always ensure the correct operating conditions and cooling function Use only suitable coolants a...

Страница 13: ...13 Risks due to electromagnetic fields This medical device complies with the reference values defined in EN 50527 2 1 2016 for active implantable medical devices AIMD and cardiac pacemakers...

Страница 14: ...s and the instrument changer Test run Do not hold the handpiece with cable at eye level Attach the handpiece with cable to the control unit Insert the instrument Put the medical device into operation...

Страница 15: ...15 3 Description Handpiece cap Light source LED socket Thread Coolant tube Nozzle cleaner SA 40 SA 40 L...

Страница 16: ...ents Insert Position the instrument in the instrument changer on the handpiece thread w Turn the instrument changer until it snaps into place e Carefully pull off the instrument changer Verify full en...

Страница 17: ...truments Remove Attach the instrument changer to the instrument w Unscrew the instrument with the instrument changer Keep the instrument in the stand until a hygiene and maintenance process is carried...

Страница 18: ...thing safety glasses face mask and gloves Use only oil free filtered compressed air with a maximum operating pressure of 3 bar for manual drying The instruments can be reprocessed in the instrument st...

Страница 19: ...ecified by the manufacturer of the disinfectant Use disinfectants which have been tested and found effective by for example the Verbund f r Angewandte Hygiene e V VAH Association for Applied Hygiene t...

Страница 20: ...d or medical devices with material changes to an authorized W H service partner Processing cycles We recommend a regular service for the W H handpiece with cable after 250 processing cycles or one yea...

Страница 21: ...least 10 seconds Ensure that all coolant outlets are rinsed out Remove the instrument Remove the handpiece with cable Wipe the entire surface of the handpiece with cable with disinfectant Note that th...

Страница 22: ...22 Hygiene and maintenance Manual cleaning Disassembling the handpiece Replacing of the LED socket SA 40 L Unscrew the handpiece cap Pull out the LED socket SA 40 Unscrew the handpiece cap...

Страница 23: ...internal and external surfaces Remove liquid residues using compressed air Instruments Clean and disinfect diamond coated instruments in an ultrasonic bath Evidence of the medical device s basic suit...

Страница 24: ...in an ultrasonic bath a washer disinfector Clean outlets carefully with the nozzle cleaner to remove dirt and deposits Blow through the coolant tube and coolant outlets using compressed air In case o...

Страница 25: ...with cleaning fluid and a soft cloth Blow the light source 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 medi...

Страница 26: ...ectant Evidence of the basic suitability of the handpiece with cable the instruments and the instrument changer for effective manual disinfection was provided by an independent test laboratory using t...

Страница 27: ...rs cleaning agents and or disinfectants Mechanical cleaning and disinfection internal and external Instruments Screw the W H adaptor into the adaptor on the injector rail Screw the instrument onto the...

Страница 28: ...automated disinfection was provided by an independent test laboratory using the Miele PG 8582 CD washer disinfector Miele Cie KG G tersloh and the Dr Weigert neodisher MediClean forte cleaning agent D...

Страница 29: ...the instrument changer are completely dry internally and externally after cleaning and disinfection Moisture in the handpiece with cable may cause a malfunction Risk of short circuit Remove liquid re...

Страница 30: ...le residual soiling and surface changes Reprocess the handpiece with cable the instruments and the instrument changer that are still soiled Sterilize the reassembled handpiece with cable the instrumen...

Страница 31: ...the medical device Replacing of the LED socket Reassemble the medical device following cleaning and disinfection SA 40 L Fit LED socket onto medical device Screw on the handpiece cap SA 40 Screw on th...

Страница 32: ...g requirements The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method The sterilization package must be large enou...

Страница 33: ...ers The program selected must be suitable for the handpiece with cable the instruments and the instrument changer Recommended sterilization procedures Dynamic air removal prevacuum cycle type B Steam...

Страница 34: ...ion S r l Brusaporto BG and the Systec VE 150 steam sterilizer Systec Dynamic air removal prevacuum cycle type B 134 C 273 F 3 minutes 132 C 270 F 4 minutes Steam flush pressure pulse cycle type S 134...

Страница 35: ...35 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 36: ...r Repairs and maintenance work must only be undertaken by an authorized W H service partner Ensure that the medical device has been completely processed before returning it Always return equipment in...

Страница 37: ...cleaner 04019000 Clips 5 pcs 06205600 LED socket 07134900 Instrument stand 06276700 Instrument changer 07233500 W H Adapter kit Use only original W H accessories and spare parts or accessories approve...

Страница 38: ...applied part not suitable for intracardiac application SA 40 SA 40 L Maximum power consumption W 24 Frequency ultrasonic kHz 22 35 Coolant flow rate at 100 ml min at least 50 Operating mode S3 80s on...

Страница 39: ...of the handpiece maximum 48 C 18 4 F Temperature of the working part instrument maximum 41 C 105 8 F Ambient conditions Temperature during storage and transport 40 C to 70 C 40 F to 158 F Humidity dur...

Страница 40: ...9 Disposal 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 Packagi...

Страница 41: ...acturing defects within a warranty period of 12 months from the date of purchase Accessories and consumables nozzle cleaner instruments clips O rings adapter kit are excluded from the warranty We acce...

Страница 42: ...42 Authorized W H service partners 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...

Страница 43: ...43...

Страница 44: ...Manufacturer Form Nr 51030 AEN Rev 002 27 09 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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