W & H Straight Handpiece Instructions for Use

Contents Symbols... 4 – 5 in the Instructions for use (4), on the medical device / packaging (5) 1. Introduction... 6 – 8 2. Safety notes... 9 – 14 3. Product description...15 – 17 Straight handpiece S-11 LED G (15) Contra-angle handpiece WS-75 LED G (16 – 17) 4. Operation... 18 – 26 Assembly/Removal (18 – 21), To change the rotary instrument (22 – 25), Test run (26)

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5. Hygiene and maintenance... 27 – 47 General (27 – 28), Pre-disinfection (29), Disassembling the medical device (30 – 32), Manual cleaning (33 – 37), Manual disinfection (38), Mechanical cleaning/disinfection/lubrication (39 – 40), Reassembling the medical device (41 – 42), Oil service (43 – 44), Sterilization and storage (45 – 47) 6. W&H Accessories and spare parts...48 – 49 7. Technical data...50 – 52 8. Disposal...53 Explanation of warranty terms...54 Authorized W&H service partners...55 3

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

Caution! According to Federal law, this medical device may only be sold by or on the order of a dentist, physician or any other medical practitioner licensed by the law of the State in which he or she practices, and who intends to use or order the use of this medical device. 4

Symbols on the medical device / packaging 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 Date of manufacture

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

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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. Intended use Surgical treatment of dental hard tissue. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties.

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Qualifications of the user The medical device is intended for use by suitably qualified, medical, technical and specialist staff only. We have based our development and design of the medical device on the physician 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. > 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 55). 7

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. Service In the event of operating malfunctions immediately contact an authorized W&H service partner (see page 55). Repairs and maintenance work must only be undertaken by an authorized W&H service partner.

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2. Safety notes > Operation of the medical device is permitted only on dental units which correspond to the Medical Device Directive. > 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. > Only attach the medical device onto the motor when the motor is at a complete standstill. > Never touch the chuck lever of the straight handpiece during operation or while it is still running down. > Never touch the push-button of the contra-angle handpiece during operation or while it is still running down. > Never touch the rotary instrument while it is still rotating. > Perform a test run each time before using. 9

> Avoid overheating at the treatment site. > Do not touch the soft tissue with the handpiece head (risk of burning)! > 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 sensor. > Do not look directly into the LED.

Danger zones M and G In accordance with IEC 60601-1 / ANSI/AAMI ES 60601-1, the medical device is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide.

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The medical device is not suitable for use in oxygen enriched atmospheres.

Zone M is defined as a »medical environment« and constitutes the part of a room in which potentially explosive atmospheres may form due to the use of anaesthetics or medical antiseptics and antibacterial soaps; such atmospheres are typically localized and temporary. Zone M comprises a truncated pyramid below the operating table which is tilted outwards at a 30° angle.

Zone G, also known as an »enclosed medical gas system«, does not necessarily include areas enclosed around all sides, in which explosive mixtures are continuously or temporarily generated, directed or used in small quantities. 11

WS-75 LED G The medical device has a considerably higher level of efficiency than normal contra-angle handpieces and has been designed to fit the W&H drive units Implantmed SI-9xx, SI-10xx, Elcomed SA-2xx and SA-3xx. If using a drive unit other than one for which the medical device has been designed, the setting for the required torque must be reduced by roughly one half. E.g., to achieve 50 Ncm on the rotating instrument with an W&H Elcomed 100 / 200, the torque must be set to 30 Ncm. The use of the medical device on surgical units other than the Implantmed SI-9xx, SI-10xx, Elcomed SA-2xx and SA-3xx, in particular those without a calibration function, represents a risk which must be considered by the user (risk of injury). W&H explicitly advises against doing this. The user is solely responsible. The manufacturer accepts no liability.

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Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and implantable cardioverter defibrillator (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. > 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.

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Hygiene and maintenance prior to initial use The medical device is in a clean condition and sealed in PE-film when delivered. > Lubricate the medical device. > Sterilize the medical device, the nozzle cleaners, the coolant tube, the Y-manifold, the spray clips and the coolant tube for internal bur cooling. > Oil service > Sterilization

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page 39, 43 page 45

3. Product description S-11 LED G  LED  Handpiece head*  Coolant tube (movable)  Chuck lever  Area of chuck lever  Shaft  Sheath*  Long nozzle cleaner * Symbols on the parts  and  Sheath open Direction of rotation Sheath locked 15

3. Product description WS-75 LED G  LED  Push-button  Contra-angle head*  Hexagon chucking system  Middle gear  Knee (with generator)  Sheath*  Hole for locking pin * Symbols on the parts  and  Sheath open Direction of rotation Sheath locked 16

3. Product description WS-75 LED G – Continuation  Spray clip for Kirschner/Meyer internal bur cooling system

 Spray clip without internal bur cooling system

 Coolant tube for internal bur cooling  Y-manifold  Nozzle cleaner

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4. Operation – Assembly/Removal S-11 LED G Coolant tube

 Fit the coolant tube. or

 Pull off the coolant tube.

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WS-75 LED G Spray clip Coolant tube for internal bur cooling

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

 Remove the coolant tube for internal bur cooling.  Remove the spray clip.

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Medical device Do not assemble or remove the medical device during operation!

 Push the medical device onto the motor. When using a locking pin between motor and medical device: See Instructions for use of the unit.

 Check the secure hold on the motor. or

 Remove the medical device from the motor by

pulling in an axial direction or by pressing the release button.

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