Air motors Instructions for Use

W&H Symbols

WARNING! (Risk of injury)

ATTENTION! (to prevent damage occurring)

Data Matrix Code for product identification, e.g. in hygienic maintenance process

General explanations, without risk to persons or objects

Sterilizable up to the stated temperature

Only for USA Caution! Federal law restricts this device to sale by or on the order of a dentist, physician or any other practitioner licensed by the law of the State in which he or she practices to use or order the use of the device. 2

Contents W&H Symbols... 2 1. Introduction... 4 – 5 2. Before use – Safety notes... 6 – 7 3. Product description... 8 4. Operation... 9 – 11 Assembly/removal, check for leakages, test run 5. Hygienic maintenance... 12 – 19 General, Pre-disinfection, Manual Cleaning, Manual Disinfection, Oil service, Sterilization 6. Exchanging the bulb (AM-25 LT)... 20 – 21 7. Exchanging O-rings (AM-25 LT/A, AM-25 A BC/RM)... 22 8. W&H Accessories... 23 – 24 Technical data... 25 Authorized Service organizations... 26 Letter of indemnity... 27

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1. Introduction Customer satisfaction is the main priority under the W&H quality policy. This W&H product has been developed, manufactured and subjected to final inspection according to legal regulations, quality norms 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 W&H product and guarantee a smooth and efficient operation. 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.

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Production according to EU Directive This air motor is a medical product according to the EU directive 93/42/EEC. Skilled application This medical product is intended only for informed use in the medical dental field according to its purpose of use in compliance with the valid health and safety at work regulations, the valid accident prevention regulations as well as in compliance with these instructions for use. The air motor should be maintained according to the manufacturer’s recommendations and in-line with infection control procedures for the safety and well-being of patients. Improper use, e.g. missing hygienic maintenance, or non-compliance with our instructions or the use of accessories and spare parts which are not released by W&H, invalidates all claims under warranty and any other claims. Service In case of service or repair contact your local retail dental supplier, or one of our authorized service organizations (see Page 26). Service and maintenance work must only be carried out by accredited W&H service organizations.

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2. Before use – Safety notes > The operation of the air motor with light 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 comply with the following requirements: >The compliance with the leakage currents of the application section must be guaranteed by the system assembler. >The secondary voltage must be non-earthed. >The secondary circuits must be protected against short-circuiting and overloading. > Danger zones M and G In accordance with IEC 60601-1 / UL 60601-1, the air motor is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. > 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 air motor must be stopped immediatealy. > Use only non-contaminated, filtered, oil-free and dry compressed air to operate the air motor. > Check the air motor for damage and loose parts prior to use. 6

Hygienic maintenance prior to initial use The air motor is in a clean condition and sealed in PE-film when delivered. Lubricate and sterilize the air motor prior to initial use. > Oil service > Sterilization

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3. Product description AM-25 LT AM-25 A, AM-25 A BC/RM, AM-25 E, AM-25 E BC/RM, AM-25, AM-25 BC/RM ➊ ISO 3964 connection ➋ Borden 2/3-hole ➌ Standard 4-hole ➍ O-ring ➎ Speed control ring ➏ Union nut ➐ Roto Quick coupling (with light connection) ➑ Motor sheath ➒ Bulb ➓ External coolant tube 8

4. Operation Air motor with Roto Quick connection assembly/removal Do not assemble/remove during the operation! ➊ Push the air motor onto the Roto Quick coupling. ➋ Check that the connection to the Roto Quick coupling is secure by pulling on it. ➌ Set the speed control ring to F or R. ➍ Check for leakages. ➎ Pull the retention sleeve of the Roto Quick coupling back and remove the air motor by pulling in an axial direction. 9

Air motor with fixed connection assembly/removal Do not assemble/remove during operation! ➊ Push the air motor with BC/RM connection into the turbine hose apertures. ➋ Screw the union nut on firmly clockwise. ➌ Set the speed control ring to F or R. ➍ Check the air motor with RM connection for leakages (not possible with BC connection, because the return air is expelled through the outer sheath). ➎ Unscrew the union nut anti-clockwise from the supply hose. 10

Test run > Start the air motor. > Turn the speed control ring to »F« forward or »R« reverse. > Vary the speed from minimum to maximum across a period of 10 seconds. > Wipe off the air motor with a soft cloth. > If you observe problems (e.g. vibrations, unusual noise, overheating, coolant supply failure or leakage), stop the motor immediately and contact an authorized service organization (see page 26).

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5. Hygienic maintenance > Follow your country-specific directives, standards and guidelines for cleaning, disinfection and sterilization. > Wear protective clothing. > Remove the transmission instrument from the air motor and set the speed control ring to F or R. > Remove the air motor from the supply hose or from the Roto Quick coupling. > Clean and disinfect the air motor immediately after every treatment. > Sterilize the air motor following manual cleaning, disinfection and lubrication.

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Pre-disinfection > If heavily soiled: Clean first with disinfectant cloths. Only use disinfectants that have no proteinfixing effects.

Manual cleaning internal and external ➊ Rinse under demineralized water (< 38 °C) with the aid of a brush (brush is not recommended in U.K.) ➋ Then remove any liquid residues (absorbent cloth, blow dry with compressed air). Do not place the air motor in liquid disinfectant or in an ultrasonic bath. 13

Cleaning the coolant tube Blow through the coolant tube a with an air syringe. In the event of clogged spray nozzles or coolant tubes contact an authorized service organization.

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Manual disinfection > Disinfection with disinfectants, ➊ wiping disinfection is recommended. > Use only disinfectants which do not contain chlorine and which are certified by officially recognized institutes. For USA: Use EPA registered disinfectants. > Note the manufacturer’s specifications for the use of the disinfectants. After manual cleaning, disinfection and lubrication you must carry out a final thermal disinfection (unwrapped) or sterilization (wrapped) in the class B or S steam sterilizer (according to EN 13060). 15

Daily oil service only with W&H Service Oil F1, MD-400 ➊ Set the speed control ring to F or R. > Follow the instructions for use of the oil spray can. Daily oil service only with W&H Assistina > See instructions for use of Assistina. Recommended lubrication cycles > essential after every internal cleaning > before each sterilization or > after 30 minutes of use or at least once daily

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Test run following oil service ➊ Set the speed control ring to F or R and position the air motor with the ISO connection downwards. ➋ Run the air motor for 30 seconds to remove excess oil. > Repeat the oil service if dirt emerges. ➌ Wipe with gauze or soft cloth.

30 sec.

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Sterilization and storage W&H recommends sterilization according to EN 13060, class B

> > > > >

Follow the operating instructions of the manufacturer. Clean, disinfect and lubricate before sterilizing. Wrap the air motor and the accessory in sterile goods packing according to EN 868-5. Make sure, that you only remove dry sterile goods. Store sterile goods dust-free and dry.

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Approved sterilization procedures Follow your country-specific directives, standards and guidelines.

> Steam sterilization class B (pre and post vaccum) with sterilizers in accordance with EN 13060. Sterilization holding time a minimum of 3 minutes at 134 °C (273.2 °F) Required pressure -0.85 bar (-12.3 psi) up to 2.16 bar (31.3 psi) or > Steam sterilization class S with sterilizers in accordance with EN 13060. The sterilizer manufacturer must give their express approval for the sterilization of air motors. Sterilization holding time a minimum of 3 minutes at 134 °C (273.2 °F) 19

6. Exchanging the bulb (AM-25 LT) Wear protective gloves! (bulb damage) ➊ Remove the air motor from the Roto Quick coupling. ➋ Remove motor sheath. ➌ Take out the bulb.

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