Supply hose Instructions for Use

Contents W&H Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 – 4 1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 – 7 2. Safety notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 – 10 3. Product description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 4. Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 – 13 Motor assembly / Motor removal 5. Hygiene and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 – 16 General, Pre-disinfection, Manual cleaning, Manual disinfection 6. Exchanging the O-ring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 – 18 7. W&H Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 8. Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 9. Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 – 22 10. Recycling and disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 Explanation of warranty terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Authorized W&H service partner . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

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W&H Symbols 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

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W&H Symbols Symbols on the supply hose Data matrix code for product identification e.g. for hygiene / maintenance processes Not suitable for intracardiac application – Type B applied part

REF

Catalogue number

SN

Serial number 4

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 Electrical drive, including the supply of cooling media, for dental transmission instruments used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation. Misuse may damage the supply hose and hence cause risks and hazards for patients, users and third parties. 5

Qualifications of the user We have based our development and design of the electric motor system (includes tubing, electric motor and control unit) on the »dentists, dental hygienists, dental employees (prophylaxis) and dental assistants« target group. Production according to EU Directive The electric motor system is a medical product according to the EU-directive 93/42/EEC. Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the supply hose when it is used in compliance with the following directions: > The supply hose must be used in accordance with these Instructions for use. > The supply hose has no components that can be repaired by the user. Assembly, modifications or repairs must only be undertaken by an authorized W&H service partner (see page 27). 6

Skilled application The supply hose is intended only for informed use in the dental or medical field according to its purpose of use in compliance with the valid health and safety at work regulations and the valid accident prevention regulations as well as in compliance with these Instructions for use. The supply hose 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. Service In case of service or repair contact an authorized W&H service partner (see page 27). Service and maintenance work must only be carried out by an authorized W&H service partner.

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2. Safety notes > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate cooling is delivered and ensure adequate suction (except in endodontic applications). In case of coolant supply failure, the supply hose must be stopped immediatealy. > Check the supply hose for damage and loose parts each time before using (e.g. O-ring). Do not operate the supply hose if it is damaged. > Use only non-contaminated, filtered, oil-free and dry compressed cooling air to operate the supply hose. > Replace faulty or leaky O-rings in the hose coupling immediately. > Run the rinse function for the dental unit once per day. > Never touch the patient and the connection of the supply hose coupling.

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> The operation of the supply hose 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: > Double insulation for the highest expected supply voltage must be provided between the primary and secondary power circuits. > The compliance with the leakage currents of the applied part must be guaranteed by the system assembler. > Double insulation for the highest expected secondary voltage must be provided between the secondary voltage and earth (PE). > The system configurator has to ensure a galvanic separation between all secundary voltages incl. light supplies. > The secondary circuits must be protected against short-circuiting and overloading. > The control electronics must only be installed in the dental unit by qualified staff who have been authorized by the unit manufacturer. The supply hose is tailored to the W&H electric motor 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. 9

Hygiene and maintenance prior to initial use The supply hose is in a clean condition when delivered. Disinfect the supply hose prior to initial use (see page 16).

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3. Product description Supply hose  Connection sheath  Connection (quick-release coupling)  O-ring  Threaded bushes

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4. Operation Assembly of the motor Do not twist, kink or squeeze the supply hose (risk of damage). Do not assemble or remove the motor during operation.  Align the connection tubes of the motor with the connection openings of the hose.  Press the motor and the hose together.

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Check  Carry out a visual inspection. Check to ensure that the motor is securely connected to the hose. The motor and hose coupling must sit flush to one another. > If the hose does not click into place, remove the hose from the motor. Slide the hose connection back to the stop and repeat points 1 to 3. Disassembly of the motor  Pull the connection sheath back up to the stop and pull the hose from the motor.

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5. Hygiene and maintenance > Follow your country-specific directives, standards and guidelines for cleaning and disinfection. > Wear protective clothing. > Do not remove the motor from the hose and make sure that no liquid can enter. > Clean and disinfect the hose immediately after every treatment. > The supply hose is not approved for mechanical cleaning (thermo washer disinfector) and sterilizing.

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Pre-disinfection > If heavily soiled: Clean first with disinfectant cloths. Only use disinfectants that have no proteinfixing effects. Manual cleaning external  Rinse and brush off under demineralized water (< 38 °C).  Remove any liquid residues (absorbent cloth, blow dry with compressed air). Do not place the hose in liquid disinfectant or in an ultrasonic bath. 15

Manual disinfection W&H recommends wiping down with disinfection. > Use only disinfectants which do not contain chlorine and which are certified by officially recognized institutes. > Note the manufacturer’s specifications for the use of the disinfectants. Before restart operation Wait until the supply hose is completely dry. Moisture in the supply hose can lead to a malfunction! (Risk of short circuit) 16

6. Exchanging the O-ring Exchange the damaged or leaking O-ring immediately. Do not use sharp tools!  Firmly squeeze together the O-ring between thumb and forefinger so as to form a loop.  Withdraw the O-ring.  Slide on the new O-ring carefully.

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Exchange damaged or leaking threaded bushes immediately.  Unscrew the threaded bush with a screwdriver.  Remove the threaded bush. Fitting the bushes  Screw in the new threaded bush with a screwdriver.

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7. W&H Accessories Use only original W&H accessories and spare parts! Suppliers: W&H partner 01218700 04586200

O-ring (page 17) Threaded bushes with O-ring (page 18)

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8. Servicing Regular checking of supply hose and accessories Regular servicing of function and safety including the accessories is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The inspection must be undertaken by a qualified organization and must include the following procedures: > External visual inspection and a check on changes relevant to safety e. g. mechanical damage of the enclosure or indications of overheating. We recommend that this checkup should be performed by an authorized W&H service partner (see page 27) or by the unit manufacturer only.

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