W&H SURGICAL WS-92 L Instructions For Use Manual
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W&H SURGICAL WS-92 L Instructions For Use Manual

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Instructions for Use
Surgical
Contra-angle handpieces
WS-56 L, WS-75 L, WS-91 L, WS-92 L
with mini LED+

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Summary of Contents for W&H SURGICAL WS-92 L

  • Page 1 Instructions for Use Surgical Contra-angle handpieces WS-56 L, WS-75 L, WS-91 L, WS-92 L with mini LED+...

  • Page 2: Table Of Contents

    Contents Symbols ....................................in the Instructions for Use ...................................4 on the medical device / packaging ..............................5 1. Introduction ..................................2. Safety notes ..................................3. Product description ................................4. Operation .................................... Assembly/Removal ....................................15 Rotary instruments ....................................19 To change the rotary instrument ..............................20 Test run ......................................
  • Page 3 Initial treatment at the point of use ..............................28 Manual cleaning ....................................29 Manual disinfection ..................................35 Automated cleaning and disinfection .............................. 36 Drying ........................................ 38 Inspection, Maintenance and Testing .............................. 39 Packaging ......................................44 Sterilization......................................45 Storage ....................................... 48 6.

  • Page 4: Symbols

    Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, Do not dispose of with (if persons could (to prevent without risk to domestic waste be injured) damage occurring) persons or objects 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.

  • Page 5: On The Medical Device / Packaging

    Symbols on the medical device / packaging CE marking DataMatrix Code Data structure in with identification number for product information accordance with XXXX of the Notified Body including UDI (Unique Health Industry Bar Code Device Identification) Catalogue number Sterilizable up to the Thermo washer stated temperature disinfectable...

  • Page 6: Introduction

    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.
  • Page 7 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: >...
  • Page 8 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.

  • Page 9: Safety Notes

    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). >...
  • Page 10 > Do not touch the soft tissue with the contra-angle head (risk of burning due to the push-button heating up)! > 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. >...
  • Page 11 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.
  • Page 12 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, the Y-manifold, the spray clips and the coolant tube for internal bur cooling system.

  • Page 13: Product Description

    3. Product description WS-56 L, WS-75 L, WS-91 L, WS-92 L  Push-button  Contra-angle head*  Middle gear  Knee  Sheath*  * Symbols on parts   Sheath open Direction of rotation Sheath locked...
  • Page 14 Product description WS-75 L Hexagon chucking system  Coolant tube for internal bur cooling  system Y-manifold  WS-91 L, WS-92 L External coolant tube  Kirschner/Meyer internal Spray nozzles  bur cooling system WS-56 L, WS-75 L Spray clips for the left and right  ...

  • Page 15: Operation

    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).
  • Page 16 WS-56 L Spray clip WS-75 L Spray clip Coolant tube for internal bur cooling system Attach the spray clip.  Insert the coolant tube for internal bur cooling  system. Remove the coolant tube for internal bur cooling  system. Remove the spray clip.
  • Page 17 Medical device Push the medical device onto the motor and turn  until it engages audibly. Verify secure hold.  Remove the medical device. ...
  • Page 18 WS-75 L Y-manifold Only when using the coolant tube for internal bur cooling system. 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 system. Insert the Y-manifold into the irrigation tubing.

  • Page 19: Rotary Instruments

    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. >...

  • Page 20: To Change The Rotary Instrument

    To change the rotary instrument WS-56 L > Instrument shaft diameter 2.35 mm Insert the rotary instrument until the limit stop.  Turn the rotary instrument until it engages.  Verify secure hold.  Activate the push-button and remove the rotary ...
  • Page 21 WS-91 L, WS-92 L > Instrument shaft diameter 1.6 mm Insert the rotary instrument.  Activate the push-button, at the same time insert  the rotary instrument until the limit stop (a). Verify secure hold.  Activate the push-button and remove the rotary ...
  • Page 22 WS-75 L > Using internal bur cooling system > Without using internal bur cooling system > With hexagon > Instrument shaft diameter 2.35 mm Insert the coolant tube for internal bur cooling  system. Remove the coolant tube for internal bur cooling  ...
  • Page 23 Verify secure hold.  Activate the push-button and remove the rotary  instrument. Ask your implant supplier for an applicable rotary instrument with hexagon.

  • Page 24: Test Run

    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.

  • Page 25: Hygiene And Maintenance

    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.
  • Page 26 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.

  • Page 27: Limitations On Processing

    Hygiene and maintenance Limitations on processing The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. > Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner.

  • Page 28: Initial Treatment At The Point Of Use

    Hygiene and maintenance Initial treatment at the point of use Clean the medical device immediately after every treatment, to flush out liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. > Operate the medical device for at least 10 seconds at idle speed. >...

  • Page 29: Manual Cleaning

    Hygiene and maintenance Manual cleaning Disassembling the medical device Remove the coolant tube for internal bur cooling  system. Remove the spray clip.  Hold the contra-angle head firmly with one hand.  Press sheath gently against knee. At the same ...
  • Page 30 Do not place the medical device in liquid disinfectant or in an ultrasonic bath. > Clean the medical device under running tap water (< 35°C / < 95°F). > Rinse and brush off all internal and external surfaces. > Move moving parts back and forth several times. >...
  • Page 31 Cleaning the external coolant tubes WS-91 L, WS-92 L: Cleaning the spray nozzles The coolant tube for internal bur cooling system, the spray clips and the nozzle cleaner can be cleaned in an ultrasonic bath and/or in the washer-disinfector. Clean coolant outlets carefully with the nozzle ...
  • Page 32 Blow through the coolant tube and coolant outlets   using compressed air. In case of blocked coolant outlets or coolant tubes contact an authorized W&H service partner.
  • Page 33 WS-75 L Cleaning the Y-manifold The Y-manifold can be cleaned in an ultrasonic bath and/or in the washer-disinfector. Rinse with running tap water (< 35°C / < 95°F).  Remove liquid residues using compressed air.  ...
  • Page 34 Cleaning the LED Avoid scratching the LED! Wash the LED with cleaning fluid and a soft cloth.  Blow the LED dry using compressed air or dry it  carefully with a soft cloth. > Carry out a visual inspection after each cleaning process.

  • Page 35: Manual Disinfection

    Hygiene and maintenance Manual disinfection > W&H recommends wiping down with disinfectant. Evidence of the medical device's basic suitability for effective manual disinfection was provided by an independent test laboratory using the disinfectants “mikrozid® AF wipes” (Schülke & Mayr GmbH, Norderstedt) and “CaviWipes™”...

  • Page 36: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. Evidence of the medical device’s basic suitability for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD«...
  • Page 37 Automated cleaning and disinfection of the external coolant tubes and spray clips Use the W&H adaptor kit REF 07233500. Screw the W&H adaptor into the adaptor on the  injector rail. Screw the W&H intermediate adaptor onto the   W&H adaptor. Put the W&H silicone hose over the W&H  ...

  • Page 38: Drying

    Hygiene and maintenance Drying > Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. > Remove liquid residues using compressed air.

  • Page 39: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, Maintenance and Testing Inspection > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled. > Sterilize the reassembled medical device following cleaning, disinfection and lubrication.
  • Page 40 Reassembling the medical device Reassemble the medical device following cleaning and disinfection. > Without spray clip > Type and serial numbers must be identical Insert the middle gear into the knee.  Insert the knee into the contra-angle head.  Check free running of the chucking system (a)  ...
  • Page 41 Lubrication > Lubricate the dry medical device immediately after cleaning and/or disinfection. Recommended lubrication cycles > Essential after every internal cleaning > Before each sterilization With W&H Service Oil F1, MD-400 > Follow the instructions on the oil spray can and on the packaging. With W&H Assistina >...
  • Page 42 WS-91 L, WS-92 L Lubrication of the chucking system With W&H Service Oil F1, MD-400 > Fit the spray adaptor REF 02036100 onto the oil spray can. > Hold the medical device firmly. > Press the tip of the spray adaptor firmly into the chucking system.
  • Page 43 Test after lubrication > Direct the medical device downwards. > Operate the medical device so that excess oil can escape. > Remove any oil that has escaped. > Excess oil may result in the medical device overheating.

  • Page 44: Packaging

    Hygiene and maintenance Packaging Wrap the medical device and the accessories in sterilization packages that meet the following requirements: > The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization procedure. >...

  • Page 45: Sterilization

    Hygiene and maintenance Sterilization W&H recommends sterilization according to EN 13060, EN 285 or ANSI/AAMI ST55. > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. > The program selected must be suitable for the medical device. >...
  • Page 46 Recommended sterilization procedures > "Dynamic-air-removal prevacuum cycle" (type B) 134⁰C (273⁰F) for at least 3 minutes, 132⁰C (270⁰F) for at least 4 minutes > "Gravity-displacement cycle" (type N) 121⁰C (250⁰F) for at least 30 minutes Maximum sterilization temperature 135°C (275°F)
  • Page 47 Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L* steam sterilizer (W&H Sterilization S.r.l., Brusaporto (BG)) and the CertoClav MultiControl MC2-S09S273** steam sterilizer (CertoClav GmbH, Traun). > “Dynamic-air-removal prevacuum cycle” (type B): 134°C (273°F) – 3 minutes*, 132°C (270°F) – 4 minutes*/** >...

  • Page 48: Storage

    Hygiene and maintenance Storage > Store sterile goods dust-free and dry. > The shelf life of the sterile goods depends on the storage conditions and type of packaging.

  • Page 49: Servicing

    6. Servicing Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner. Repairs and maintenance work must only be undertaken by an authorized W&H service partner. > Ensure that the medical device has been completely processed before returning it.

  • Page 50: W&H Accessories And Spare Parts

    7. W&H Accessories and spare parts Use only original W&H accessories and spare parts or accessories approved by W&H. Supplier: W&H partners 000301xx Assistina 301 plus 30310000 Assistina TWIN (MB-302) 02693000 Assistina adaptor for chucking system 10940021 Service Oil F1, MD-400 (6 pcs) 02038200 Spray adaptor 02036100...
  • Page 51 06016400 Y-manifold (3 pcs) 02610500 Coolant tube for internal bur cooling system Spray clip for the left (3 pcs) 06946300 Kirschner/Meyer internal bur cooling system 06948400 Without internal bur cooling system Spray clip for the right (3 pcs) 06948300 Kirschner/Meyer internal bur cooling system 06949500 Without internal bur cooling system 08014690...

  • Page 52: Technical Data

    8. Technical data WS-75 L Transmission ratio 20:1 Colour coding green Permitted motor connection (W&H) EM-19 LC / EM-19 Ø Rotary instruments ISO 1797 ( 2.35 Maximum permitted bur length (mm) Minimum chucking length engaging Maximum drive speed (rpm) 50,000 Coolant volume ISO 14457 (ml/min) >...
  • Page 53 Technical data WS-56 L WS-91 L / WS-92 L Transmission ratio 1:2,7 Colour coding blue orange Permitted motor connection (W&H) EM-19 LC / EM-19 Ø Rotary instruments ISO 1797 ( 2.35 Maximum permitted bur length (mm) Minimum chucking length engaging until limit stop Maximum drive speed (rpm)
  • Page 54 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Temperature of the medical device on the patient side: maximum 50°C (122°F) Temperature of the working part (rotary instrument): maximum 41°C (105.8°F) Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Air Humidity during storage and transport: 8 % to 80 % (relative), non-condensing...

  • Page 55: Disposal

    9. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and national laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...

  • Page 56: Explanation Of Warranty Terms

    Explanation of warranty terms This medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantee faultless operation. Please note that claims under warranty can only be validated when all the directions in the Instructions for use have been followed.

  • Page 57: Authorized W&H Service Partners

    Authorized W&H service partners Find your nearest authorized W&H service partner at http://wh.com Simply go to the menu option »Service« for full details. Or simply scan the QR code.
  • Page 58 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50885 AEN t + 43 6274 6236-0, f + 43 6274 6236-55 Rev. 003 /27.01.2021 office@wh.com wh.com Subject to alterations...

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