Electric Motor and Supply Hose Instructions for Use

Contents Symbols... 4 1. Introduction... 7 2. Safety notes... 10 3. Product description... 14 4. Operation... 16

Screw on the motor...16 Unscrew the motor... 17 Test run...19

5. Hygiene and maintenance... 20

General notes...20 Limitations on processing... 22 Initial treatment at the point of use...23 Manual cleaning...24 Cleaning of the optic outlet... 25

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Manual disinfection...26 Drying... 27 Inspection, Maintenance and Testing...28 Packaging...29 Sterilization...30 Storage... 32

6. Maintenance... 33 7. Servicing... 36 8. W&H Accessories and spare parts... 38 9. Technical data... 39 10. Data on electromagnetic compatibility according to IEC/EN 60601-1-2... 41 11. Disposal... 46 Explanation of warranty terms... 47 Authorized W&H service partners...48 3

Symbols

WARNING! (risk of injury)

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

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.

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Symbols

on the motor / packaging

CE marking with identification number of the Notified Body

XXXX

Consult Instructions for Use Catalogue number +70 °C (+158°F) Max.

Serial number

80 %

8%

Humidity limitation

-40 °C (-40°F) Min.

DataMatrix Code for product information including UDI (Unique Device Identification)

Data structure in accordance with Health Industry Bar Code

Sterilizable up to the stated temperature

Date of manufacture

Permitted temperature range

Medical Device

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements

Manufacturer

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Symbols XXXX

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on the supply hose

CE marking with identification number of the Notified Body

Type B applied part (not suitable for intracardiac application)

Catalogue number

Serial number

Medical Device

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 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 medical device and hence cause risks and hazards for patient, user and third parties. 7

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. 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 medical device 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 48).

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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. > 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. > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. > Use only the filtered, oil-free and cooled air supplied by dental compressors for drive air. > Perform a test run each time before using. > Do not look directly into the light source. > Never touch the patient and the electrical contacts on the medical device simultaneously.

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> The medical device is not approved for operation in potentially explosive atmospheres. > 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). > Moisture in the medical device may cause a malfunction. (Risk of short circuit) > The medical product is lubricated for life and therefore should not be lubricated. > Do not twist, kink or squeeze the supply hose (risk of damage). > Replace damaged or leaking O-rings immediately. > 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.

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Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable 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. > Do not place the motor on the patient’s body. > 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. Rotational energy Fast deceleration of the bur can, at times, cause the selected torque to be temporarily exceeded, compared to the value set, as a result of the rotational energy stored in the drive system. 12

Transmission instruments > Follow the directions and safety notes in the Instructions for Use of the transmission handpieces. > Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturer approved transmission instruments. > Follow the directions of the manufacturer of transmission handpieces with reference to transmission ratio, maximum speed and maximum torque. 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 and disinfect the medical device. > Sterilize the medical device.

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3. Product description

Motor

 

  

 14

 Motor shealt  LED  Connection for instruments as per ISO 3964  O-rings  Seal  Alignment pin (only for EM-11 L)

Product description

Supply hose  Tubing sleeve  Connection  Alignment hole (only for EM-11 L)

  

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4. Operation

Screw on the motor Do not assemble or remove the medical device during operation! 

 Push the motor onto the supply hose. Note the alignment aids  Screw the tubing sleeve and the motor together. 

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 Carry out a visual inspection. The motor and the tubing sleeve coupling must sit flush to one another. 

Verify full engagement. 

Unscrew the motor  Unscrew the supply hose from the motor.

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Assembly and removal of transmission instruments Do not assemble or remove the medical device during operation!



 Push the transmission instrument onto the motor and turn it until it engages audibly. 

 Verify full engagement. 

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 Remove the transmission instrument from the motor.

Test run > Do not hold the medical device at eye level. > Start the medical device using the attached transmission instrument. 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. > Remove the transmission instrument from the medical device. > Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying. > The motor is not approved for automated processing in a washer-disinfector. > Note the dental manufacturer´s reprocessing instructions for the supply hose. > The supply hose is not approved for automated processing in a washer-disinfector and sterilization.

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