WS Series Contra-angle and Generator Instructions for Use Rev 004 March 2015

Contents Symbols... 4 – 5 in the Instructions for use (4), on the contra-angle handpiece / on the packaging (5) 1. Introduction... 6 – 8 2. Safety notes... 9 – 14 General (9 – 11), Contra-angle handpiece with mini LED+ and generator (12 – 14) 3. Product description... 15 – 16 4. Operation... 17 – 25 Assembly/Removal (17 – 19), To change rotary instrument (20 – 24), Test run (25)

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5. Hygiene and maintenance...26 – 46 General (26 – 27), Pre-disinfection (28), Disassemble (29), Manual cleaning (30 – 35), Manual disinfection (36), Mechanical cleaning/disinfection/lubrication (37 – 38), Reassemble (39), Oil service (40 – 43), Sterilization and storage (44 – 46) 6. W&H Accessories and spare parts...47 7. Technical data...48 – 50 8. Recycling and disposal... 51 – 52 Explanation of warranty terms...53 Authorized W&H service partners...55

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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! 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.

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Symbols on the contra-angle handpiece / on the packaging CE 0297 from the manufacturer

REF Catalogue number

Thermo washer disinfectable

SN

Sterilizable up to the stated temperature

Serial number

Date of manufacture

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

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 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 Surgical treatment of dental hard tissue. Misuse may damage the contra-angle handpiece and hence cause risks and hazards for patient, user and third parties.

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Qualifications of the user The contra-angle handpiece is intended for use by suitably qualified, medical, technical and specialist staff only. We have based our development and design of the contra-angle handpiece on the physician target group. Production according to EU Directive The contra-angle handpiece 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 contra-angle handpiece when it is used in compliance with the following directions: > The contra-angle handpiece must be used in accordance with these Instructions for use. > The contra-angle handpiece 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 contra-angle handpiece is intended only for skilled application in surgery 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 contra-angle handpiece 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 – General > The operation of the contra-angle handpiece 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 contra-angle handpiece must be stopped immediately. > Check the contra-angle handpiece for damage and loose parts each time before using (e.g., push-button). > Do not operate the contra-angle handpiece if it is damaged. > Only attach the contra-angle handpiece onto the motor, when the motor is at a complete standstill. > Never touch the push-button of the contra-angle handpiece during operation or while it is still running down. > Never touch the rotary instrument which is still rotating. > Perform a test run each time before using. > Avoid overheating at the treatment site. > Do not touch the soft tissue with the contra-angle head (risk of burning due to the push-button heating up)! 9

The WS-75 L G / WS-75 contra-angle handpiece 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-95, Implantmed SI-923 / SI-915, Elcomed SA-200 / SA-200 C and Elcomed SA-310. If using a drive unit other than one for which the WS-75 L G / WS-75 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 contra-angle handpiece WS-75 L G / WS-75 on surgical units other than the Implantmed SI-95, Implantmed SI-923 / SI-915, Elcomed SA-200 / SA-200 C and Elcomed SA-310, 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. No liability is accepted by W&H.

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Hygiene and maintenance prior to initial use The contra-angle handpiece is in a clean condition and sealed in PE-film when delivered.

> Lubricate the contra-angle handpiece. > Sterilize the contra-angle handpiece, the nozzle cleaner, the Y-manifold, the spray clips and the coolant tube for internal bur cooling. > Oil service > Sterilization

page 40 page 44

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2. Safety notes – Contra-angle handpiece with mini LED+ and generator > Avoid contact between LED and soft tissue (risk of burning due to the LED heating up). > Do not use the contra-angle handpiece as 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 contra-angle handpiece is not suitable for use in potentially explosive atmospheres or with potentially explosive mixtures of anaesthetic substances containing oxygen or nitrous oxide. The contra-angle handpiece is not suitable for use in oxygen enriched atmospheres.

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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.

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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 product and consider the application. > Weigh the risks and benefits. > Keep the product 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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3. Product description WS-56 L G, WS-75 L G, WS-91 L G, WS-92 L G  LED

 Push-button  Contra-angle head*  Middle gear  Knee (with generator)  Sheath*  Hole for locking pin * Symbols on the parts  and  = Sheath open = Direction of rotation = Sheath locked 15

3. Product description – Continuation WS-75 L G, WS-75  Hexagon chucking system  Coolant tube for internal bur cooling  Y-manifold WS-91 L G, WS-91, WS-92 L G, WS-92

 External coolant tube  Spray nozzles

 Spray clip for the left and right

for Kirschner/Meyer internal bur cooling system  Spray clip for the left and right without internal bur cooling system  Nozzle cleaner 16

4. Operation – Assembly/Removal WS-75 L G, WS-75 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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Contra-angle handpiece Do not assemble or remove the contra-angle handpiece during the operation!

 Push the contra-angle handpiece onto the motor. When using a locking pin between motor and contra-angle handpiece: See Instructions for use of the unit.

 Check the secure hold on the motor. or

 Remove the contra-angle handpiece from the 18

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

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

 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.  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 contra-angle is stationary. > Never touch the rotary instrument which is still rotating. > Do not activate the push-button of the contra-angle handpiece during operation. This leads to detachment of the rotary instrument and/or makes the contra-angle hot.

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