MODUS Angulated Screwdriver 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 WSD-90... 11 4. Operation... 12 Assembly/removal...12 5. Hygiene and maintenance... 19 General notes...19 Limitations on processing...21 Initial treatment at the point of use... 22 Automated cleaning and disinfection... 27 Automated cleaning and disinfection... 28 2

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

Manual cleaning...23 Manual disinfection... 26 Drying... 29 Inspection, Maintenance and Testing... 30 Packaging... 36 Sterilization... 37 Storage... 39 6. Servicing... 40 7. Accessories and spare parts... 41 8. Technical data... 42 9. Disposal... 44 Explanation of warranty terms... 45 Authorized service partners... 47

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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Symbols

in the Instructions for Use

WARNING! (risk of injury)

ATTENTION! (to prevent damage occurring)

UL Component Recognition Mark indicates compliance with Canadian and U.S. requirements 4

General explanations, no 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.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

Symbols XXXX

CE marking with identification number of the Notified Body

DataMatrix Code for product information including UDI (Unique Device Identification)

on the medical device/packaging Thermo washer disinfectable

Catalogue number

Sterilizable up to the stated temperature

Serial number

Date of manufacture

Equipment number

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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1. Introduction Customer satisfaction is the main priority our quality policy. This medical device 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 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

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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 service partner (see page 47). MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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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 us, 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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MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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). >> The medical device should only be operated with sufficiently powerful drive motors. >> The maximum permitted drive speed of 1750 rpm must not be exceeded. >> Always ensure that you have the correct operating conditions. >> Check the medical device for damage and loose parts each time before using (e.g. retaining clip). >> 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 prior to each use. >> Avoid overheating at the treatment site. >> Unintended use may result in the medical device getting hot (risk of burning)! >> Always ensure that you have a second right angled screwdriver ready for use during the operation. MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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Hygiene and maintenance prior to initial use >> The medical device is not sterilized when delivered. >> The packaging is non-sterilizable. >> Clean, disinfect and lubricate the medical device. >> Sterilize the medical device and the turning attachment.

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MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

3. Product description WSD-90 90° Screwdriver

 

 Head  Sheath  Shaft  Tension clamp  Screwholding fork  Retaining clip  Clip  Rotation knob  Symbol description



   

 

 = Sheath open  = Sheath locked

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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4. Operation

Assembly/removal Do not assemble or remove the medical device during operation!



 Place the medical device on the motor or turning attachment.

 Verify full engagement.

 or  12

 Remove the medical device.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

Rotary instrument (bur and screwdriver blade) >> Only use rotary instruments which are in perfect condition and pay attention to the direction of rotation of rotating instruments. Follow the operating instructions of the manufacturer. >> Insert the rotary instrument only when the medical device is stationary. >> Only use the screwdriver blade with the turning attachment. >> Never touch the rotary instrument while it is still rotating. >> Never touch the tension clamp of the medical device during use. This leads to detachment of the rotary instrument and/or overheating of the medical device.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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Changing the rotary instrument 

 Push the tension clamp forwards in the axial direction.

 Then insert the tool into the head until limit stop  Turn the tool in order to make sure that it is fully inserted.



 Pull the tension clamp completely backwards in the axial direction until it engages.



 Verify full engagement.   14

The tension clamp should engage without force being exerted. If the tension clamp does not engage, check steps 2 and 3.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

Changing the rotary instrument 

 To remove the tool, push the tension clamp forwards.

Remove the tool. or Remove the tool by pressing with a pair of tweezers.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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Use of the screwholding fork and the retaining clip

 Insert the screwdriver blade.  

 Guide the screw onto the screwdriver blade.  Push the bolt retainer forwards until the screw is held by the retaining clip.

The retaining clip of the screw holding fork only provides a secure hold for screws measuring ≥ Ø 2.0 mm  16

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

Use of the screwholding fork and the retaining clip  

 After inserting the first few threads, pull the screwholding fork backwards.

 Tighten the screw until secure. In the rear position, the screwholding fork can be turned 90° to the left or right.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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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) stop the medical device immediately and contact an authorized service partner.

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MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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.

MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

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Cleaning agents and disinfectants >> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. >> Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant. >> Use disinfectants which have been tested and found effective by the Verbund für Angewandte Hygiene e.V. (VAH = Association for Applied Hygiene), the Österreichische Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available.

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MANDIBLE-00000901_RevH Instructions for Use for MODUS 90° Screwdriver Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland