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Related Manuals for W&H proxeo ULTRA PB-5 L
Summary of Contents for W&H proxeo ULTRA PB-5 L
- Page 1 Instructions for use Handpiece PB-5 L, PB-5 L S, PB-5 L Q...
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Page 2: Table Of Contents
Contents Symbols....................................in the Instructions for use .................................. 4 on the medical device ..................................5 packaging ......................................6 1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Assembly/Removal ................................... 16 Changing the tip ....................................17 Test run ......................................20 5. - Page 3 Initial treatment at the point of use ..............................24 Manual cleaning ....................................25 Manual disinfection ..................................29 Automated cleaning and disinfection ..............................30 Drying ........................................ 31 Inspection, Maintenance and Testing .............................. 32 Packaging ......................................34 Sterilization ....................................... 35 Storage ....................................... 38 6.
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Page 4: Symbols
Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of (risk of injury) (to prevent without risk to with domestic waste damage occurring) persons or objects Type B applied part (not suitable for intracardiac application) -
Page 5: On The Medical Device
Symbols on the medical device CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Thermo washer Thread system: disinfectable Q-Link W&H... -
Page 6: Packaging
Symbols packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) 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. -
Page 7: Introduction
1. Introduction Customer satisfaction has absolute priority in the W&H quality policy. This medical device has been developed, manufactured and subjected to final inspection according to legal regulations, quality and industry standards. For your safety and the safety of your patients Prior to initial use please read the Instructions for use. - Page 8 Qualifications of the user We have based our development and design of the medical device on the dentists, dental hygienists, dental employees (prophylaxis) and dental assistants target group. Production according to EU Directive The medical device meets the requirements of Directive 93/42/EEC. Responsibility 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:...
- Page 9 Skilled application The medical device is intended only for skilled application according to the intended use as well as in compliance with the valid health and safety at work regulations, the valid accident prevention regulations and in compliance 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.
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Page 10: Safety Notes
2. Safety notes > Before using the medical device for the first time, store it at room temperature for 24 hours. > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction (except for tips where no coolant is used). - Page 11 Tips > Only use tips that have been approved by W&H and the associated tip changers or spanners. > An overview of the correct power settings is included with every tip. > With periodontal tips, the medical device is suitable for the removal of concretions in the subgingival region, but not for applications which demand sterile conditions.
- Page 12 Approved coolants and rinsing liquids > Physiological saline solution (NaCl, 0.9%) > Hydrogen peroxide (H 2 O 2 , 1–3%) > Liquids with the active substance chlorhexidine (CHX, 0.2%) > Tap water...
- Page 13 The medical device is tailored to the W&H supply hose and the W&H control electronics and must therefore only be used with W&H products. Using other components 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 for active implantable medical devices (AIMD) and cardiac pacemakers.
- Page 14 Hygiene and maintenance prior 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, the tips and the tip changer.
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Page 15: Product Description
3. Product description Thread Connection for supply hose Handpiece cap Optical fibre Optic outlet Nozzle cleaner ... -
Page 16: Operation
4. Operation Assembly/Removal Push the medical device onto the supply hose. Note the positioning. Remove the medical device. ... -
Page 17: Changing The Tip
Operation Changing the tip Insert tip with tip changer Ensure the matching thread system (at the handpiece, tip changer, tip)! Position the tip on the thread of the medical device. Turn the tip changer until it audibly engages. ... - Page 18 Remove tip with tip changer Place the tip changer onto the tip. Unscrew the tip with the tip changer. Leave the tip in the tip changer until the hygienic maintenance process! ...
- Page 19 Insert/remove tip with spanner Position the tip on the thread of the medical device. Screw the tip down. Verify full engagement. Unscrew the tip. ...
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Page 20: Test Run
Test run Do not hold the medical device at eye level! > Attach the medical 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 the medical device immediately and contact an authorized W&H service partner. -
Page 21: Hygiene And Maintenance
5. Hygiene and maintenance General notes Follow your local 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 with a maximum operating pressure of 3 bar for manual drying. - Page 22 Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. > Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic.
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Page 23: Limitations On Processing
Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and 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. -
Page 24: Initial Treatment At The Point Of Use
Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. > Operate the medical device for at least 10 seconds at idle speed. >... -
Page 25: Manual Cleaning
Hygiene and maintenance Manual cleaning Disassembling the medical device Unscrew the handpiece cap. Remove the optical fibre. ... - Page 26 Hygiene and maintenance Manual cleaning Do not place the medical device and the tip changer in liquid disinfectant or in an ultrasonic bath. Clean and disinfect diamond coated tips in an ultrasonic bath. Evidence 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«...
- Page 27 Cleaning the spray nozzles Clean coolant outlets carefully with the nozzle cleaner to remove 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 ...
- Page 28 Cleaning the optic outlet and the optical fibre Avoid scratching the optic outlet and the optical fibre! Wash the optic outlet and the optical fibre with cleaning fluid and a soft cloth. Blow the optic outlet and the optical fibre dry using compressed air or dry it carefully with a soft cloth.
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Page 29: Manual Disinfection
Hygiene and maintenance Manual disinfection > W&H recommends wiping 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 the »mikrozid® AF wipes« disinfectant (Schülke &... -
Page 30: Automated Cleaning And Disinfection
Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. Evidence 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«... -
Page 31: Drying
Hygiene 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 compressed air. -
Page 32: Inspection, Maintenance And Testing
Hygiene and maintenance Inspection, Maintenance and Testing 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 tip and the tip changer that are still soiled. - Page 33 Reassembling the medical device Reassemble the medical device following cleaning and disinfection. Fit optic fibre onto medical device. Screw on the handpiece cap. Sterilize the medical device, the tip and the tip changer following cleaning and disinfection.
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Page 34: Packaging
Hygiene and maintenance Packaging Pack the medical device, the tip and the tip changer in sterilization packages 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. - Page 35 Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST79. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device. >...
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Page 36: Sterilization
Recommended sterilization cycles > Steam sterilization (type B, S, N) > Sterilization time at least 3 minutes at 134°C (273°F), 4 minutes at 132°C (270°F), 30 minutes at 121°C (250°F) > Maximum sterilization temperature 135°C (275°F) Evidence of the basic suitability of the medical device, the tip and the tip changer for effective sterilization was provided by 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 steam sterilizer (CertoClav GmbH, Traun). - Page 37 Before starting operation 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 cooled down. (Risk of burning)
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Page 38: Storage
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. -
Page 39: Exchanging The Supply Hose O-Rings
6. Exchanging the supply hose O-rings Remove O-rings. Slide on the new O-rings with a pair of tweezers. Always change all O-rings to ensure tightness. ... -
Page 40: Servicing
7. Servicing Repairs and returns In the event of 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 has been completely processed before returning it. -
Page 41: W&H Accessories And Spare Parts
8. W&H Accessories and 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 for hose coupling (1 pc) -
Page 42: Technical Data
9. Technical data PB-5 L, PB-5 L S, PB-5 L Q Max. power output to the handpiece with load (ultrasonic) Frequency (ultrasonic) (kHz) 22–35 Minimum coolant supply volume (ml/min) 0*/20 Maximum coolant supply volume (ml/min) Water pressure (bar) 1–6 Max. oscillating amplitude (Tip 1U) (mm) * for tips where no coolant is used Classification according to §... - Page 43 Temperature information Temperature of the medical device at the operator side: maximum 71°C (159.8°F) Temperature of the medical device at the patient side (front area of the medical device): maximum 50°C (122°F) Temperature of the medical device at the patient side (optical fibre): maximum 48°C (118.4°F) Temperature of the working part (tip):...
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Page 44: Disposal
10. 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... -
Page 45: Explanation Of Warranty Terms
Explanation of warranty terms This W&H medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for use have been followed. -
Page 47: Authorized W&H Service Partners
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. - Page 48 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51005 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 002 / 03.02.2020 office@wh.com wh.com Subject to alterations...