44 Pages
Preview
Page 1
Instructions for use
Air motors AM-25, AM-25 A, AM-25 LT, AM-25 E
Contents Symbols...4 1. Introduction...6 2. Safety notes...9 3. Product description...13 4. Operation...15 Assembly/Removal - Quick coupling...15 Test run...16 5. Hygiene and maintenance...17 General notes...17 Limitations on processing...19 Initial treatment at the point of use...20 Manual cleaning... 21 Manual disinfection...23 2
Drying...24 Inspection, Maintenance and Testing...25 Packaging...28 Sterilization...29 Storage...32 6. Maintenance...33 7. Servicing...36 8. W&H Accessories and spare parts...37 9. Technical data...39 10. Disposal...41 Explanation of warranty terms... 42 Authorized W&H service partners...43
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Symbols
in the Instructions for use
WARNING! (risk of injury)
ATTENTION! (to prevent damage occurring)
General explanations, without risk to persons or objects
Do not dispose of with domestic waste
on the medical device/packaging Medical Device
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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
Date of manufacture
Sterilizable up to the stated temperature
Serial number
UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements
Forward-/Reverse drive
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 licensed by the law of the State in which the practitioner practices to use or order the use of the device. 5
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 air motor is intended for the following applications: Drive for dental transmission instruments for dental restoration and prophylaxis. Supply of dental transmission instruments with cooling air, chip air, spray water and light. 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. >> Only the components approved by the manufacturer may be replaced (Lamp, O-rings). >> Modifications or repairs must only be undertaken by an authorized W&H service partner. (see page 43)
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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. Any serious incident that has occurred in relation to the medical device should be reported to the manufacturer and the competent authority!
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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 dental 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: (Relates to medical device with halogen lamp) >> 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. (maximum 700mA) >> The leakage currents of the applied part must be kept. >> The secondary voltage in operation must be limited to a maximum of 3.3 V AC/DC. 9
Safety notes >> 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. O-ring). >> Do not operate the medical device if it is damaged. >> Perform a test run before each use. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the treatment water decontamination system, as well as its handling. >> Always follow recommendations made by the manufacturer of the transmission instrument and the rotary instrument.
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Safety notes >> Do not look directly into the light source. >> Never touch the patient and the electrical contacts on the medical device simultaneously. >> Replace faulty or leaky O-rings immediately. >> The medical device is not approved for operation in potentially explosive atmospheres. (only for AM-25 LT)
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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.
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3. Product description AM-25 LT, AM-25 A, AM-25 E, AM-25
ISO 3964 connection W&H Quick coupling O-ring Speed control ring Quick coupling Motor sheath Lamp External coolant tube
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Product description Speed control
Maximum speed Forward drive (F) Reverse drive (R)
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The air motor is set to »F« (forward) when delivered.
4. Operation
Assembly/Removal - Quick coupling Do not assemble or remove the medical device during the operation!
Push the medical device onto the Quick coupling.
Verify full engagement
or
Pull back the sleeve of the Quick coupling Remove the air motor by pulling it axially 15
Test run Do not hold the air motor at eye level. >> Start the medical device idle for 5 seconds. >> Turn the speed control ring to »F« forward or »R« reverse. >> Vary the speed from minimum to maximum. 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. The information on the validated reprocessing methods serves as an example for an ISO 17664 compliant reprocessing of the medical device. >> Wear protective clothing, safety glasses, face mask and gloves. >> Remove the transmission instrument from the air motor. >> Set the speed control ring to F or R. >> Remove the air motor from the supply hose. >> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar (43,5psi) for manual drying. 17
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 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. 18
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. Processing cycles >> Safe use is guaranteed until at least 1,000 reprocessing cycles.
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Hygiene and maintenance
Initial treatment at the point of use
Clean the medical device immediately after every treatment, to flush out any 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. >> Ensure that all coolant outlets are rinsed out. >> Wipe the entire surface of the medical device with disinfectant. >> Remove the motor from the supply hose. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning.
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