Surgical Handpiece 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... 13 4. Operation... 14 Assembly/Removal...14 Rotary instruments...17 To change the rotary instrument... 18 Test run...19 5. Hygiene and maintenance... 20 General notes... 20 Limitations on processing... 22 Initial treatment at the point of use...23 2

Manual cleaning... 24 Manual disinfection... 29 Automated cleaning and disinfection... 30 Drying... 32 Inspection, Maintenance and Testing... 33 Packaging... 38 Sterilization... 39 Storage...41 6. Servicing... 42 7. W&H Accessories and spare parts... 43 8. Technical data... 44 9. Disposal... 46 Explanation of warranty terms... 47 Authorized W&H service partners... 49

3

Symbols

WARNING! (if persons could be injured)

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! 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 intends to use or order the use of this medical 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 temperature

Serial number Date of manufacture

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements 5

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. 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. 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 49). 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 only 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!

8

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 coolant 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 micromotor when the motor is at a complete standstill. >> Do not activate the chuck lever of the medical device during operation. This leads to detachment of the rotary instrument and/or makes the medical device hot. >> Perform a test run each time before using. >> Avoid overheating at the treatment site. 9

>> 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 LED.

The medical device is not approved for operation in potentially explosive atmospheres.

10

Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemaker 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.

11

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.

12

3. Product description  LED  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 13

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.

14

Coolant tube

 Fit the coolant tube. or

 Pull off the coolant tube.

15

Medical device

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

 Verify secure hold. or

 Remove the medical device.

16

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 and/or makes the medical device hot.

17

To change the rotary instrument

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

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

18

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 leaking) stop the medical device immediately and contact an authorized W&H service partner.

19

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. >> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying.

20