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Symbols

CE marking

with identification number

of the Notified Body

DataMatrix Code

for product information

including UDI (Unique

Device Identification)

Data structure in

accordance with

Health Industry Bar Code

XXXX

packaging

Caution! According to Federal law, this medical device may only be

sold by or on the order of a dentist, physician or any other medical

practitioner licensed by the law of the State in which he or she

practices and intends to use or order the use of this medical device.

Содержание proxeo ULTRA PB-5 L

Страница 1: ...Instructions for use Handpiece PB 5 L PB 5 L S PB 5 L Q...

Страница 2: ...use 4 on the medical device 5 packaging 6 1 Introduction 7 2 Safety notes 10 3 Product description 15 4 Operation 16 Assembly Removal 16 Changing the tip 17 Test run 20 5 Hygiene and maintenance 21 G...

Страница 3: ...and disinfection 30 Drying 31 Inspection Maintenance and Testing 32 Packaging 34 Sterilization 35 Storage 38 6 Exchanging the supply hose O rings 39 7 Servicing 40 8 W H Accessories and spare parts 41...

Страница 4: ...se WARNING risk of injury ATTENTION to prevent damage occurring General explanations without risk to persons or objects Symbols Do not dispose of with domestic waste Type B applied part not suitable f...

Страница 5: ...on including UDI Unique Device Identification Date of manufacture Serial number Catalogue number CE marking with identification number of the Notified Body XXXX Thread system Q Link W H Satelec Steril...

Страница 6: ...ation Data structure in accordance with Health Industry Bar Code XXXX packaging Caution According to Federal law this medical device may only be sold by or on the order of a dentist physician or any o...

Страница 7: ...d the Instructions for use These explain how to use your medical device and guarantee a smooth and efficient operation Observe the safety notes Intended use Drive unit with a piezoceramic oscillating...

Страница 8: ...er 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 medical device must...

Страница 9: ...nce with these Instructions for use The medical device should be prepared for use and maintained by staff who have been trained in procedures for infection control personal safety and patient safety I...

Страница 10: ...mediately maximum operating time without coolant is 30 seconds The exception are applications where no coolant is used e g endodontics Maximum operating time without coolant is 2 minutes Check the med...

Страница 11: ...tment Ensure that the original shape of the tips is not affected e g by being dropped The tips must not be bent back into shape or resharpened Locate and secure the tip only with the medical device sw...

Страница 12: ...12 Approved coolants and rinsing liquids Physiological saline solution NaCl 0 9 Hydrogen peroxide H2O2 1 3 Liquids with the active substance chlorhexidine CHX 0 2 Tap water...

Страница 13: ...ponents could lead to deviating parameters or even the destruction of the system Risks due to electromagnetic fields This medical device complies with the reference values defined in EN 50527 2 1 2016...

Страница 14: ...or to initial use The medical device is not sterilized when delivered The packaging is non sterilizable Clean and disinfect the medical device the tips and the tip changer Sterilize the medical device...

Страница 15: ...15 3 Product description Thread Connection for supply hose Handpiece cap Optical fibre Optic outlet Nozzle cleaner...

Страница 16: ...16 4 Operation Assembly Removal Push the medical device onto the supply hose Note the positioning w Remove the medical device...

Страница 17: ...at the handpiece tip changer tip Position the tip on the thread of the medical device w Turn the tip changer until it audibly engages e Withdraw the tip changer Verify full engagement Press the tip w...

Страница 18: ...18 Remove tip with tip changer Place the tip changer onto the tip w Unscrew the tip with the tip changer Leave the tip in the tip changer until the hygienic maintenance process w...

Страница 19: ...19 Insert remove tip with spanner Position the tip on the thread of the medical device w Screw the tip down Verify full engagement e Unscrew the tip w...

Страница 20: ...device to the supply hose Insert the tip Put the medical device into operation In the event of operating malfunctions e g vibrations unusual noise overheating coolant supply failure or leakage stop th...

Страница 21: ...and national laws directives standards and guidelines for cleaning disinfection and sterilization Wear protective clothing safety glasses face mask and gloves Use only oil free filtered compressed air...

Страница 22: ...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 23: ...chemical influences due to processing Send worn or damaged medical devices and or medical devices with material changes to an authorized W H service partner Processing cycles We recommend a regular se...

Страница 24: ...ternal parts Operate the medical device for at least 10 seconds at idle speed Ensure that all coolant outlets are rinsed out Wipe the entire surface of the medical device the tip and the tip changer w...

Страница 25: ...25 Hygiene and maintenance Manual cleaning Disassembling the medical device Unscrew the handpiece cap w Remove the optical fibre w...

Страница 26: ...dence of the tips basic suitability for effective manual cleaning and disinfection was provided by an independent test laboratory using the Bandelin Type RK 100 CC ultrasonic bath and the cleaning age...

Страница 27: ...move dirt and deposits The nozzle cleaner can be cleaned in an ultrasonic bath and or in the washerdisinfector Cleaning the coolant tube Blow through the coolant tube using compressed air In the case...

Страница 28: ...l fibre with cleaning fluid and a soft cloth w Blow the optic outlet and the optical fibre dry using compressed air or dry it carefully with a soft cloth Carry out a visual inspection after each clean...

Страница 29: ...iping down with disinfectant Evidence of the medical device s the tips and the tip changer s basic suitability for effective manual disinfection was provided by an independent test laboratory using th...

Страница 30: ...vidence of the basic suitability of the medical device the tip and the tip changer for effective automated disinfection was provided by an independent test laboratory using the Miele PG 8582 CD washer...

Страница 31: ...ene and maintenance Drying Ensure that the medical device the tip and the tip changer are completely dry internally and externally after cleaning and disinfection Remove liquid residues using compress...

Страница 32: ...nd maintenance Inspection Check the medical device the tip and the tip changer after cleaning and disinfection for damage visible residual soiling and surface changes Reprocess any medical devices the...

Страница 33: ...vice Reassemble the medical device following cleaning and disinfection Fit optic fibre onto medical device w Screw on the handpiece cap Sterilize the medical device the tip and the tip changer followi...

Страница 34: ...s that meet the following 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 pa...

Страница 35: ...ow the instructions and heed the warnings provided by the manufacturers of steam sterilizers The program selected must be suitable for the medical device Only sterilize the tip in the tip changer This...

Страница 36: ...an independent test laboratory using the LISA 517 B17L steam sterilizer W H Sterilization S r l Brusaporto BG the Systec VE 150 steam sterilizer Systec and the CertoClav MultiControl MC2 S09S273 stea...

Страница 37: ...again Wait until the medical device is completely dry Moisture in the medical device can lead to a malfunction Risk of short circuit Wait until the tip the tip changer and the spanner have completely...

Страница 38: ...38 Hygiene and maintenance Storage Store sterile goods dust free and dry The shelf life of the sterile goods depends on the storage conditions and type of packaging...

Страница 39: ...39 6 Exchanging the supply hose O rings Remove O rings w Slide on the new O rings with a pair of tweezers Always change all O rings to ensure tightness w...

Страница 40: ...f operating 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...

Страница 41: ...spare parts Use only original W H accessories and spare parts or accessories approved by W H Suppliers W H partners 08025210 Handpiece cap and 3 optical fibres 00636901 Nozzle cleaner 02060203 O ring...

Страница 42: ...ml min 0 20 Maximum coolant supply volume ml min 50 Water pressure bar 1 6 Max oscillating amplitude Tip 1U mm 0 2 for tips where no coolant is used Classification according to 6 of the General Speci...

Страница 43: ...ient side optical fibre maximum 48 C 118 4 F Temperature of the working part tip maximum 41 C 105 8 F Ambient conditions Temperature during storage and transport 40 C to 70 C 40 F to 158 F Humidity du...

Страница 44: ...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 Packaging...

Страница 45: ...in a warranty period of 24 months from the date of purchase Accessories and consumables tips tip changer nozzle cleaner are excluded from the warranty We accept no responsibility for damage caused by...

Страница 46: ......

Страница 47: ...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 47...

Страница 48: ...Form Nr 51005 AEN Rev 002 03 02 2020 Subject to alterations Manufacturer 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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