Surgical Contra-Angle Handpieces Instructions for Use

Contents Symbols... 4 1. Introduction... 6 2. Safety notes... 9 3. Product description... 13 4. Operation... 15 Assembly/Removal...15 Rotary instruments...19 To change the rotary instrument... 20 Test run... 24

5. Hygiene and maintenance... 25 General notes... 25 Limitations on processing... 27 Initial treatment at the point of use... 28 Manual cleaning... 29

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Manual disinfection... 35 Automated cleaning and disinfection... 36 Drying... 37 Inspection, Maintenance and Testing... 38 Packaging... 43 Sterilization... 44 Storage... 47

6. Servicing... 48 7. Accessories, consumables, spare parts and other recommended medical devices by W&H... 49 8. Technical data... 51 9. Information on electromagnetic compatibility according to IEC/EN 60601-1-2 ... 54 10. Disposal... 57 Explanation of warranty terms... 58 Authorized W&H service partners... 59 3

Symbols

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

General explanations, without risk to persons or objects

Caution! According to Federal law restricts this device to sale by or on the order of a physician, dentist, 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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Do not dispose of with domestic waste

Manufacturer

Symbols XXXX

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

Medical Device

Date of manufacture

Consult Instructions for Use

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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 Surgical treatment of organic hard tissue. Intended part of the body > Mouth > Mouth Space 6

Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. Qualifications of the user We have based our development and design of the medical device on the physician 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 59).

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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 supply units which correspond to the standards IEC 60601-1 (EN 60601-1) and IEC 60601-1-2 (EN 60601-1-2). > Always ensure the correct operating conditions and cooling function. > Always ensure that sufficient and adequate coolant 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. > Only attach the medical device onto the motor when the motor is at a complete standstill. > Do not activate the push-button of the medical device during operation. This leads to detachment of the rotary instrument, damage to the chucking system and/or heating up of the medical device. Risk of burning! > Perform a test run each time before using. > Avoid overheating at the treatment site. 9

> Do not touch the soft tissue with the contra-angle head (risk of burning due to the push-button heating up)! > Avoid contact between LED and soft tissue (risk of burning due to the LED heating up). > Do not use the medical device as a light probe. > Do not look directly into the light source. The medical device is not approved for operation in potentially explosive atmospheres. The medical device is not approved for operation in oxygen rich environment. WS-75 L

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The medical device has a considerably higher level of efficiency than normal contra-angle handpieces and has been designed to fit W&H drive units. When using the medical device on other surgical units, the user assumes sole responsibility. The manufacturer accepts no liability. Any concessions can be granted directly by the manufacturer of the drive units.

Risks due to electromagnetic fields The functionality of active implantable medical devices (AIMD) (e.g. cardiac pacemaker, ICD) can be affected by electric, magnetic and electromagnetic fields. > Find out if the patient has active implantable medical devices (AIMD) before using the medical device and inform about the risks. > Do not place the applied part on the patient’s body.

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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, the nozzle cleaner, the Y-manifold, the spray clips and the coolant tube for internal bur cooling system.

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3. Product description WS-56 L, WS-75 L, WS-91 L, WS-92 L  LED  Push-button  Contra-angle head*  Middle gear  Knee  Sheath*

* Symbols on parts  and  Sheath open Direction of rotation Sheath locked 13

Product description WS-75 L  Hexagon chucking system  Coolant tube for internal bur cooling system  Y-manifold WS-91 L, WS-92 L

Kirschner/Meyer internal bur cooling system

 External coolant tube  Spray nozzles WS-56 L, WS-75 L

  Spray clips for the left and right without internal bur cooling system

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WS-56 L, WS-75 L, WS-91 L, WS-92 L  Nozzle cleaner

4. Operation

Assembly/Removal

Do not assemble or remove the medical device during operation! The medical device is matched to W&H electric motor EM-19 LC / EM-19 and to W&H Implantmed SI-10xx. You can only make full use of all the medical device's advantages in this combination (e.g., constant illumination at every speed). The medical device may only be used with W&H electric motor EM-19 LC / EM-19. The user accepts sole responsibility if the medical device is used on other electric motors. The manufacturer accepts no liability.

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WS-56 L Spray clip WS-75 L Spray clip Coolant tube for internal bur cooling system

 Attach the spray clip.  Insert the coolant tube for internal bur cooling system.

Check the secure hold of the spray clip and replace it if necessary. or

 Remove the coolant tube for internal bur cooling system.

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 Remove the spray clip.

Medical device

 Push the medical device onto the motor and turn until it engages audibly.

 Verify full engagement. or

 Remove the medical device.

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WS-75 L Y-manifold Only when using the coolant tube for internal bur cooling system.

 Insert the coolant hose of the Y-manifold onto the

coolant tube of the spray clip and onto the coolant tube for internal bur cooling system.  Insert the Y-manifold into the irrigation tubing. or

 Remove the Y-manifold.

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Rotary instruments > Use only rotary instruments which are in perfect condition and pay attention to the direction of rotation of the rotary instrument. Follow the operating instructions of the manufacturer. > Insert the rotary instrument only when the medical device is stationary. > Never touch the rotary instrument while it is still rotating. > Do not activate the push-button of the medical device during operation. This leads to detachment of the rotary instrument, damage to the chucking system and/or heating up of the medical device. Risk of burning! When having a torque higher than 30 Ncm on the rotary instrument you have to use hardened shafts (>50 HRC, >520 HV) (risk of deformation).

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To change the rotary instrument WS-56 L > Instrument shaft diameter 2.35 mm

 Insert the rotary instrument until the limit stop.  Turn the rotary instrument until it engages.  Verify full engagement. or

 Activate the push-button and remove the rotary instrument.

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