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MANDIBLE-00000901_RevG

Instructions for Use for MODUS 90° Screwdriver

Medartis, APTUS, MODUS, TriLock, HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG, 4057 Basel/Switzerland

1. Introduction

Customer satisfaction is the main priority of our quality policy . This 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

Please read the instructions for use booklet before using this product for the first time . This explains to you how to

use your product and guarantees smooth, efficient and safe operation .

Intended use

Surgical treatment of dental hard tissue .

Misuse can damage the 90° screwdriver and involves risk and danger to the patient, user and third parties .

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Содержание WSD-90

Страница 1: ...r WSD 90 Instructions for use MANDIBLE 00000901_RevG Instructions for Use for MODUS 90 Screwdriver Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland ...

Страница 2: ...ription WSD 90 10 4 Operation 11 17 Assembly removal rotating instruments changing the rotating instrument use of the screwholding fork and the retaining clip test run 5 Hygiene and maintenance 18 33 General pre disinfection disassembly manual cleaning manual disinfection mechanical cleaning and disinfection reassembly oil service sterilization 6 Accessories 34 7 Technical data 35 36 8 Recycling a...

Страница 3: ...RNING risk of injury ATTENTION to prevent damage occurring General explanations no risk to persons or objects Caution According to the federal law of the USA the sale of this device is only permitted by or on instruction of a dentist a doctor or another medical practitioner who is licensed to work in the state in which they are practising and in which they want to use or arrange the use of this de...

Страница 4: ... and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Symbols Symbols on the 90 screwdriver Catalogue number Serial number Thermo washer disinfectable Sterilizable up to the stated temperature Date of manufacture Identification number of notified body REF SN Equipment number EN ...

Страница 5: ... manufactured and subjected to final inspection according to legal regulations quality norms and industry standards For your safety and the safety of your patients Please read the instructions for use booklet before using this product for the first time This explains to you how to use your product and guarantees smooth efficient and safe operation Intended use Surgical treatment of dental hard tis...

Страница 6: ...r on the physician target group Production according to EU directive The 90 screwdriver is a medical product according to EU Directive 93 42 EEC Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety reliability and performance of the 90 screwdriver when the following directions are complied with The 90 screwdriver must be used in compliance with these in...

Страница 7: ...well as in compliance with these instructions for use The 90 screwdriver 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 poor hygiene and maintenance non compliance with our instructions or the use of accessories and spare parts which are not approved by us for the WSD 90 invalidat...

Страница 8: ... drive speed of 1750 rpm must not be exceeded Always ensure that you have the correct operating conditions Check the 90 screwdriver for damage and loose parts prior to use e g retaining clip Do not operate the 90 screwdriver if it is damaged Only fit the 90 screwdriver when the motor is at a complete standstill Never touch the rotary instrument when it is still rotating Carry out a test run prior ...

Страница 9: ...TUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Hygiene and maintenance prior to initial use Oil service prior to initial use Sterilize the 90 screwdriver and the rotation knob Oil service page 30 Sterilization page 32 ...

Страница 10: ...TUS 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 ...

Страница 11: ...tered trademarks of Medartis Holding AG 4057 Basel Switzerland 4 Operation Assembly removal Do not assemble remove during operation Place the 90 screwdriver on the motor or rotation knob Check that the connection to the motor or rotation knob is secure Remove the 90 screwdriver using axial tension or by pressing the unlocking button ...

Страница 12: ...ch are in perfect condition and pay attention to the direction of rotation of rotating instruments Observe the manufacturer s recommendations Insert the rotary instrument only when the 90 screwdriver is stationary Only use the screwdriver blade with the rotation knob Never touch rotary instruments which are still rotating Never touch the tension clip of the 90 screwdriver during use This leads to ...

Страница 13: ...t Pushthetensionclampforwardsinanaxialdirection Then insert the tool into the head until it reaches the 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 The tension clamp should engage without force being exerted If the tension clamp does not engage check steps 2 and 3 Check that the tool is secur...

Страница 14: ...dartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland a b Changing the rotary instrument Toremovethetool pushthetensionclampforwards Remove the tool or Remove the tool by pressing with a pair of tweezers a b ...

Страница 15: ...f Medartis Holding AG 4057 Basel Switzerland Use of the screwholding fork and the retaining clip Insert the screwdriver blade Guide the screw onto the screwdriver blade Push the screwholding fork 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 ...

Страница 16: ...peedTip 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 ...

Страница 17: ...emarks of Medartis Holding AG 4057 Basel Switzerland Test run Do not hold the 90 screwdriver at eye level Attach the 90 screwdriver to the motor Insert the rotary instrument Start the motor If you observe problems e g vibrations unusual noise overheating stop the 90 screwdriver immediately and contact an authorized service partner see page 40 ...

Страница 18: ...fectionandsterilization The 90 screwdriver can be prepared manually or mechanically Wear protective clothing Remove the 90 screwdriver from the motor or rotation knob Remove the rotary instrument Clean and disinfect the 90 screwdriver and the accessories immediately after every treatment to rinse out any liquids that may have entered e g blood saliva etc and prevent seizing up of the internal part...

Страница 19: ...are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Reassemble the dismantled 90 screwdriver after manual cleaning and disinfection the type respectively the EN number on the sheath head and shaft must match Sterilize the 90 screwdriver following manual or mechanical cleaning disinfection and oil service ...

Страница 20: ...rewdriver Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Pre disinfection If heavily soiled clean first with disinfectant cloths Only use disinfectants that have no protein fixing effects ...

Страница 21: ...ck HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Disassembly of the 90 screwdriver Turn the screwholding fork into the unlocking position Push the screwholding fork forwards until the clip releases Remove the screwholding fork in a forwards direction ...

Страница 22: ...river Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Screw on the shaft Remove the shaft from the sheath Loosen the head from the sheath by turning it from to Remove the sheath from the head ...

Страница 23: ... are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Manual cleaning internal and external Rinse under demineralized water 38 C with the aid of a brush Remove any liquid residues absorbent cloth blow dry with compressed air Do not place the 90 screwdriver in disinfectant solution or in an ultrasonic bath ...

Страница 24: ...d Manual disinfection Medartis recommends disinfection by wiping Use only disinfectants which do not contain chlorine and which are certified by officially recognized institutes Note the manufacturer s specifications for the use of the disinfectants After manual cleaning disinfection and oil serviceyoumustcarryoutafinalsterilization wrapped in the class B or S steam sterilizer as per EN 13060 ...

Страница 25: ...rnal The 90 screwdriver can be cleaned and disinfected in a thermo washer disinfector Medartis recommends processing in the thermo washer disinfector Follow the manufacturer s recommendations for devices and cleaning and rinsing agents Ensure that the 90 screwdriver is completely dry both inside and out following thermo washer disinfection Remove any liquid residues with compressed air Oil the dry...

Страница 26: ...er Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Machine cleaning in the thermo washer disinfector Ensure that the dismantled 90 screwdriver is placed in the thermo washer disinfector correctly ...

Страница 27: ...DUS 90 Screwdriver Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Assembling the 90 screwdriver Check that the type respectively the EN number on the sheath head and shaft match ...

Страница 28: ...ck HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Assembling the 90 screwdriver Insert the head into the sheath until it engages Pay attention to the symbols and turn from to until it locks Push the shaft into the sheath and screw this tightly in place ...

Страница 29: ...driver Medartis APTUS MODUS TriLock HexaDrive and SpeedTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Assembling the 90 screwdriver Push the screwholding fork until it audibly engages Pay attention to the positioning and tighten the clip ...

Страница 30: ...edTip are registered trademarks of Medartis Holding AG 4057 Basel Switzerland Oil service With Service Oil F1 or another oil approved for handpieces contra angles Follow the instructions in the manufacturers instructions for use Recommended lubrication cycles Essential after internal cleaning Before each sterilization ...

Страница 31: ...7 Basel Switzerland Test run following oil service Position the 90 screwdriver with the head pointing downwards Let the 90 screwdriver run for 30 seconds in order to remove excess oil Start at the minimum speed and increase to maximum speed within 5 10 seconds Repeat the entire hygiene and maintenance process if dirt emerges Wipe the 90 screwdriver with gauze or a soft cloth ...

Страница 32: ...esigned for sterilization in the corresponding instrument tray Please observe the instructions for use provided If the 90 screwdriver is to be sterilized individually wrap the 90 screwdriver and accessories in sterile goods packaging according to EN 868 5 Make sure that you only remove dry sterile goods from the sterilizer Store sterile goods in a dust free and dry condition The standard ISO 7785 ...

Страница 33: ...w your country specific directives standards and guidelines Steam sterilization class B with sterilizers in accordance with EN 13060 Sterilization holding time of a minimum of 3 minutes at 134 C or Steam sterilization class S with sterilizers in accordance with EN 13060 The sterilizer manufacturer must give express approval for the sterilization of handpieces contra angles Sterilization holding ti...

Страница 34: ...Holding AG 4057 Basel Switzerland 6 Accessories Only use original Medartis accessories and replacement parts or WSD 90 accessories approved by Medartis Supplier Medartis AG M 2440 90 Screwdriver Complete M 2441 90 Screwdriver M 2442 Screwholding Fork for 90 Screwdriver M 2443 Rotation Knob for 90 Screwdriver Supplier W H 1094011 Service Oil F1 02038200 Spray cap ...

Страница 35: ... Note only use tools approved for the 90 screwdriver 2 35 W H special chuck system Max speed min 1 1 750 Max torque on tool Ncm 120 Drive torque at stable speed Ncm at least 3 For tools which are not approved for use in the 90 screwdriver by the manufacturer the user must choose the correct operating conditions in order to ensure that there is no risk to the user the patient or third parties We re...

Страница 36: ...ator s side max 55 C Temperature of the 90 screwdriver on the patient s side max 50 C Temperature of the working part rotating instruments max 41 C Physical characteristics Temperature during storage and transport 40 C to 70 C Air humidity during storage and transport 8 to 80 relative non condensing Ambient temperature during operation 10 C to 35 C Air humidity during operation 15 to 80 relative n...

Страница 37: ...ling We consider that we have a special duty towards the environment The 90 screwdriver along with its packaging has been designed to be as environmentally friendly as possible Disposal of the 90 screwdriver Follow your country specific laws directives standards and guidelines for the disposal of used electrical devices Upon disposal ensure that the parts are not contaminated 8 Recycling and dispo...

Страница 38: ...country specific laws directives standards and guidelines for disposal All packaging materials have been selected according to environmentally compatible and disposal aspects and can be recycled Please send old packaging materials to the relevant collection and reprocessing system In this way you will contribute to the recycling of raw materials and the avoidance of waste Disposal of the packaging...

Страница 39: ...from the date of purchase We accept no responsibility for damage caused by improper handling or by repairs carried out by third parties not authorized to do so by Medartis Claims under warranty accompanied by proof of purchase must be sent to Medartis The provision of service under warranty extends neither the warranty period nor any other guarantee period Explanation of warranty terms 12 month wa...

Страница 40: ...ding AG 4057 Basel Switzerland Authorized service partners For service requests please contact your sales representative or the responsible Medartis branch in your country Medartis works in collaboration with service partners authorised by W H Visit the Medartis website at www medartis com You can find the contact details for your local partner on the Location page ...

Страница 41: ......

Страница 42: ...erstrasse 60E 4057 Basel Schweiz t 41 61 63334 34 f 41 61 63334 00 info medartis com www medartis com MANDIBLE 00000901_RevG 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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