W&H EM-19 Instructions For Use Manual
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W&H EM-19 Instructions For Use Manual

W&H EM-19 Instructions For Use Manual

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Instructions for use
Electric motor
EM-19 / EM-19 LC

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Summary of Contents for W&H EM-19

  • Page 1 Instructions for use Electric motor EM-19 / EM-19 LC...

  • 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 ....................................14 Test run .......................................15 5. Hygiene and maintenance..............................General notes......................................16 Limitations on processing ................................
  • Page 3 Manual disinfection ...................................21 Automated cleaning and disinfection .............................. 22 Drying .........................................23 Inspection, Maintenance and Testing .............................. 24 Packaging ......................................25 Sterilization......................................26 Storage ....................................... 28 6. Servicing .................................... 7. W&H Accessories and spare parts ........................... 8. Technical data ................................... 9. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 ..............10.

  • Page 4: Symbols

    Symbols in the Instructions for use WARNING! ATTENTION! General explanations, Do not dispose of with (risk of injury) (to prevent without risk to domestic waste 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 Type B applied part (not with identification number suitable for intracardiac for product information XXXX of the Notified Body including UDI (Unique application) Device Identification) UL Component Recognition Consult Instructions for Use Manufacturer Mark indicates compliance with Canadian and U.S.

  • 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 Only suitably qualified medical, technical and specialist trained staff may use the medical device. 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: >...
  • 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. > Check the medical device for damage and loose parts each time before using. > Do not operate the medical device if it is damaged. >...
  • Page 10 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.
  • Page 11 Transmission instruments > Follow the directions and safety notes in the Instructions for Use of the transmission instruments. > Only use transmission instruments with an ISO 3964 (DIN 13940) compatible coupling system and manufacturerapproved transmission instruments. > Follow the directions of the manufacturer of transmission instruments with reference to transmission ratio, maximum speed and maximum torque.

  • Page 12: Product Description

    3. Product description Motor sheath  Electrical contacts*  O-Ring   Motor cable   *only EM-19 LC   ...

  • Page 13: Operation

    4. Operation Do not assemble or remove the medical device during operation!   Connect motor cable. Pay attetion to the positioning.   Verify full engagement.

  • Page 14: Assembly/Removal

    Operation Assembly/Removal Do not assemble or remove the medical device during operation! Push the transmission instrument onto the  medical device and turn it until it engages audibly. Verify full engagement.  Remove the transmission instrument from the  medical device by pulling in an axial direction.

  • Page 15: Test Run

    Test run Do not hold the medical device at eye level. > Start the medical device using the attached transmission instrument. In the event of operating malfunctions (e.g., vibrations, unusual noise or overheating)stop the medical device immediately and contact an authorized W&H service partner.

  • Page 16: 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. > Remove the transmission instrument from the medical device. >...
  • Page 17 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 18: 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 19: 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. > Wipe the entire surface of the meeical device with disinfectant. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning.

  • Page 20: Manual Cleaning

    Hygiene and maintenance Manual cleaning 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. >...

  • Page 21: 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 22: 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 23: 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 24: 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 medical device following cleaning and disinfection.

  • Page 25: Packaging

    Hygiene and maintenance Packaging Pack 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 method. >...

  • Page 26: 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. Recommended sterilization procedures >...
  • Page 27 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*/** “Gravity-displacement cycle”...

  • Page 28: 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 29: Servicing

    6. Servicing Periodic inspection Regular periodic inspection of the function and safety of the medical device is necessary and should be carried out at least once every three years, unless shorter intervals are prescribed by law. The periodic inspection covers the complete medical device and must only be performed by an authorized service partner.
  • Page 30 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 31: 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. Suppliers: W&H partners 04363600 Disposable irrigation tubing set 2.2 m (6 pcs) 06290600 Hose clips (5 pcs)

  • Page 32: Technical Data

    8. Technical data Motor EM-19 / EM-19 LC Direction of rotation forward / reverse Speed range 200 – 40.000 rpm Maximum torque at the motor 6,2 Ncm Coolant volume flow at 100%: min. 90 ml/min Maximum power output: 80 W...
  • Page 33 Temperature information Temperature of the medical device on the operator side: maximum 55°C (131°F) Ambient conditions Temperature during storage and transport: -40°C to +70°C (-40°F to +158°F) Humidity during storage and transport: 8% to 80% (relativ), non-condensing Temperature during operation: +10°C to +35°C (+50°F to +95°F) Humidity during operation: 15% to 80% (relativ), non-condensing...

  • Page 34: Data On Electromagnetic Compatibility According To Iec/En 60601-1-2

    9. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 Operating environment and EMC warning notes This medical device is neither life-sustaining nor coupled to the patient. It is suitable for operation both in domestic healthcare and in facilities used for medical purposes except rooms/areas, in which EMC interference of high- intensity may occur.
  • Page 35 Portable RF communication devices Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to the medical device. Otherwise, degradation of the performance of this medical device could result. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.
  • Page 36 Results of the electromagnetic tests Requirement Class / Test Level* Electromagnetic emissions Mains terminal disturbance voltage (Conducted Emissions) Group 1 CISPR 11/EN 55011[150 kHz – 30 MHz] Class B Electromagnetic radiation disturbance (Radiated Emissions) Group 1 CISPR 11/EN 55011[30 MHz – 1000 MHz] Class B Harmonic distortion IEC/EN 61000-3-2 Class A...
  • Page 37 Proximity fields from RF wireless communications equipment 385 MHz 27 V/m IEC/EN 60601-1-2 Table 9 450 MHz 28 V/m IEC/EN 61000-4-3 9 V/m 710 / 745 / 780 MHz 810 / 870 / 930 MHz 28 V/m 1720 / 1845 / 1970 / 2450 MHz 28 V/m 9 V/m 5240 / 5500 / 5785 MHz...

  • Page 38: Disposal

    10. 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 39: 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 40: 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 42 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50983 AEN t + 43 6274 6236-0, f + 43 6274 6236-55 Rev. 001 / 18.10.2021 office@wh.com wh.com Subject to alterations...

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Em-19 lc

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