48 Pages
Preview
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Instructions for Use
RK-97 L, RG-97 L
Contents Symbols... 4
in the Instructions for use... 4 on the medical device / packaging... 5
1. Introduction... 6 2. Safety notes... 9 3. Product description... 14 4. Operation... 15
Assembly / Removal... 15 To change rotary instrument...17 Test run... 18
5. Hygiene and maintenance... 19
General notes... 19 Limitations on processing...21 Initial treatment at the point of use... 22
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Manual cleaning... 23 Automated cleaning and lubrication... 26 Manual disinfection...27 Automated cleaning and disinfection... 28 Drying... 29 Inspection, Maintenance and Testing...30 Packaging... 34 Sterilization... 35 Storage...37
6. Servicing... 38 7. W&H Accessories and spare parts... 39 8. Technical data... 40
with W&H control unit...40 without W&H control unit...41
9. Disposal... 44 Explanation of warranty terms... 45 Authorized W&H service partner... 46
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Symbols
WARNING! (risk of injury)
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in the Instructions for use
ATTENTION! (to prevent damage occurring)
General explanations, without risk to persons or objects
Do not dispose of with domestic waste
Symbols XXXX
on the medical device / packaging
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
Catalogue number
Thermo washer disinfectable
Sterilizable up to the stated temperature
Serial number
UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements
Date of manufacture
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 who intends to use or order the use of this medical device.
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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. These explain how to use your medical device and guarantee a smooth and efficient operation. Observe the safety notes. Intended use The dental turbine is intended for the following applications: Removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 6
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: >> The medical device must be used in accordance with these Instructions for Use. >> The handpiece has no components that can be repaired by the user. >> Modifications or repairs must only be undertaken by an authorized W&H service partner (see page 46).
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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. Improper use, (e.g., through poor hygiene and maintenance), non-compliance with our instructions or the use of accessories and spare parts which are not approved by W&H, invalidates all claims under warranty and any other claims.
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2. Safety notes >> Before using the medical device for the first time, store it at room temperature for 24 hours. >> The operation of the medical device is permitted only on supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). The power supply unit for the dental unit must satisfy the following requirements to be guaranteed by the system assembler: >> Double insulation for the highest expected supply voltage must be provided between the primary and secondary power circuits. >> Double insulation for the highest expected secondary voltage must be provided between the secondary voltage and protective earth (PE). >> The secondary circuits must be galvanically isolated from each other. >> The secondary circuits must be protected against short-circuiting and overloading. >> The leakage currents of the applied part must be kept. >> The secondary voltage in operation must be limited to a maximum of 4,2 V AC or 6 V DC. 9
>> Use only the supply hoses as specified by EN ISO 9168. >> Always ensure the correct operating conditions and cooling function. >> Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction. >> In case of coolant supply failure, the medical device must be stopped immediately. >> Use only the filtered, oil-free and cooled air supplied by dental compressors for drive air. >> Check the medical device for damage and loose parts before each use (e.g. push-button). >> Do not operate the medical device if it is damaged. >> Perform a test run before each use. >> Avoid overheating at the treatment site. >> Do not use the medical device if there are soft tissue wounds in the mouth. The air pressure can cause septic substances to enter the tissue or trigger embolisms. >> Do not lift the cheek or tongue with the medical device. Risk of burning due to the push-button heating up!
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>> Run the rinse function for the dental unit once per day. >> Do not use the medical device as a light probe. >> Do not look directly into the LED.
RK-97 L, RG-97 L are not approved for operation in potentially explosive atmospheres.
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Risks due to electromagnetic fields RK-97 L, RG-97 L The functionality of implantable systems, such as cardiac pacemakers and cardioverter defibrillators (ICD) can be affected by electric, magnetic and electromagnetic fields. >> 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. >> Make appropriate emergency provisions and take immediate action on any signs of ill-health. >> Symptoms such as raised heartbeat, irregular pulse and dizziness can be signs of a problem with a cardiac pacemaker or ICD (implantable cardioverter defibrillator).
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Hygiene and maintenance prior to initial use >> The medical device is sealed 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 and the nozzle cleaner.
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3. Product description
RK-97 L, RG-97 L with Roto Quick coupling
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RK-97 L
RG-97 L
Push-button w Spray nozzles e LEDs r Grip profile t Sheath y Nozzle cleaner
4. Operation
Assembly / Removal
Do not assemble or remove the medical device during operation! Push the medical device onto the Roto Quick coupling. w Verify full engagement. e Pull the retention sleeve of the Roto Quick coupling back and remove the medical device by pulling in an axial direction.
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Rotary instruments >> Use only rotary instruments which are in perfect condition. Follow the operating instructions of the manufacturer. >> Insert the rotary instrument only when medical device is stationary. >> Do not interfere with the running or slowing down of the rotary instrument. >> Do not activate the push-button of the medical device during operation or slowing down. This leads to detachment of the rotary instrument resp. heating of the push-button (risk of injury). >> Only use rotary instruments up to the maximum operating speed stipulated by the manufacturer. Operation without W&H control unit The functions of the medical device are limited, if it is not operated with a W&H control unit! >> no speed control >> RK-97 L: no light
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To change rotary instrument
Insert the rotary instrument. Activate push-button, at the same time insert the rotary instrument until back stop. w Verify full engagement.
e Remove the rotary instrument by pushing the push-button.
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Test run Do not hold the medical device at eye level! >> Insert the rotary instrument. >> Start the medical device. In the event of operating malfunctions (e.g. vibrations, unusual noise, overheating, coolant failure or leakage) stop the medical device immediately and contact an authorized W&H service partner.
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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 (43,5psi) for manual drying.
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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. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant. >> Use disinfectants which have been tested and found effective, for example by: the Verbund für Angewandte Hygiene e.V (VAH = Association for Applied Hygiene), the Österreichischen Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) or the U.S. Environmental Protection Agency (EPA). The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available. 20