Surgical Handpieces with Mini LED+ and Generator Instructions for Use

Contents Symbols... 4 in the Instructions for Use...4 on the medical device/packaging...5

1. Introduction... 6 2. Safety notes... 9 3. Product description... 14 4. Start-up... 16 Assembly/Removal ...16 Rotary instruments... 18 To change the rotary instrument ...19 Test run... 20

5. Hygiene and maintenance...21 General notes...21 Limitations on processing...23

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Initial treatment at the point of use... 24 Manual cleaning... 25 Manual disinfection... 33 Automated cleaning and disinfection... 34 Drying... 36 Inspection, Maintenance and Testing... 37 Packaging... 44 Sterilization... 45 Storage... 48

6. Servicing... 49 7. W&H Accessories and spare parts... 50 8. Technical data... 51 9. Disposal... 54 Explanation of warranty terms... 55 Authorized W&H service partners... 57 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. 4

Symbols XXXX

on the medical device/packaging

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 temperatures

Serial number

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

Medical Device

Date of manufacture

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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 dental hard tissue. Misuse may damage the medical device and hence cause risks and hazards for patient, user and third parties. 6

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 57).

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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 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. > Perform a test run each time before using. > Avoid overheating at the treatment site.

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> Do not touch the soft tissue with the handpiece head (risk of burning)! > 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.

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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 the W&H drive units Amadeo M-UK10xx, 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 Amadeo M-UK10xx, 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 precautions 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 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 and the coolant tube.

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3. Product description

S-11 L G, S-11, S-15

 LED (only S-11 L G)  Handpiece head*  Coolant tube (movable)  Chuck lever  Area of chuck lever  Shaft  Sheath*  Long nozzle cleaner * Symbols on parts  and  Sheath open Direction of rotation Sheath locked 14

Product description

S-16, S-9 LG

alle zutreffenden

S-9 L G, S-9, S-10, S-12, S-16

S-12

 LED (only S-9 L G)  Handpiece head*  Coolant tube (movable)  Chuck lever  Area of chuck lever  Shaft  Knee*  Lower shaft  Sheath*  Long nozzle cleaner * Symbols on parts ,  and  Sheath open Direction of rotation Sheath locked 15

4. Start-up

Assembly/Removal Coolant tube

 Fit the coolant tube. Check the secure hold of the coolant tube and replace it if necessary. or

 Pull off the coolant tube.

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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 control unit.

 Verify full engagement.

 Remove the medical device 17

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 chuck lever 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

 Unlock and swivel the chuck lever.  Insert the rotary instrument until limit stop.  Return the chuck lever to the initial position.  Verify full engagement. or

 Unlock and swivel the chuck lever.  Remove the rotary instrument.

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Test run Do not hold the medical device at eye level! > Insert the rotary instrument. > Operate the medical device. 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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