W&H C-NW Instructions For Use Manual
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W&H C-NW Instructions For Use Manual

Foot control
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Instructions for use
Foot control
C-NW, C-NF

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Summary of Contents for W&H C-NW

  • Page 1 Instructions for use Foot control C-NW, C-NF...

  • Page 2: Table Of Contents

    Contents Symbols ....................................1. Introduction ..................................2. Scope of delivery ................................3. Safety notes ..................................4. Description..................................5. Start-up ....................................6. Hygiene and maintenance..............................General notes......................................21 Limitations on processing .................................23 Initial treatment at the point of use ..............................24 Manual cleaning ....................................25 Manual disinfection ..................................
  • Page 3 7. Servicing ..................................... 8. Accessories, consumables, spare parts and other recommended medical devices by W&H ........9. Technical data ..................................10. Data on electromagnetic compatibility according to IEC/EN 60601-1-2 ..............11. Disposal ................................... Explanation of warranty terms .............................39 Authorized W&H service partners ............................

  • Page 4: Symbols

    Symbols WARNING! Serial number Medical device (risk of injury) ATTENTION! Catalogue number This way up (to prevent damage occurring) General explanations, Date of manufacture Fragile, handle with care without risk to persons or objects Consult Instructions for Use Manufacturer Keep dry...
  • Page 5 Symbols Do not dispose with Trademark of RESY OfW Class II medical domestic waste GmbH for identification of electrical equipment recyclable transport and outer packaging of paper Data structure in Non-ionizing and cardboard accordance with electromagnetic Health Industry Bar Code radiation “Der Grüne Punkt”...
  • Page 6 Symbols Foot control UL Component Recognition cordless C-NW Mark indicates compliance with Canadian and U.S. requirements Reset Humidity limitation 80 % Temperature limitation +60 °C (+140°F) Max. -20 °C (-4°F) Min.
  • Page 7 Symbols Caution! According to Federal law RCM – Australia / New Zealand restricts this device to sale by or on the order of a physician, dentist, veterinarian or with the descriptive ANATEL – Brazil 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 8: Introduction

    1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your medical device. However, we must also warn against possible hazardous situations. Your safety, the safety of your team and, of course, the safety of your patients are of paramount importance to us.
  • Page 9 Qualifications of the user We have based our development and design of the medical device on the target group “dentist, dental hygienist, dental employees (prophylaxis) and dental assistants”. Hereby, W&H declares that the medical device is in compliance with Directive 2014/53/EU (RED). The full text of the EU declaration of conformity is available at the following internet address https://wh.com Responsibility of the manufacturer The manufacturer can only accept responsibility for the safety, reliability and performance of the medical device...
  • Page 10 > The electrical installation at the premises must comply with the regulations laid out in IEC 60364-7-710 (“Installation of electrical equipment in rooms used for medical purposes”) or with the regulations applicable in your country. > Unauthorized opening of the medical device invalidates all claims under warranty and any other claims. Improper use, unauthorized assembly, modification or repair to the medical device, 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.

  • Page 11: Scope Of Delivery

    2. Scope of delivery Description 30316000 Foot control C-NW with Stick Description 30316002 Foot control C-NW with Stick, Charging cable Description 04717300 Foot control C-NF...

  • Page 12: Safety Notes

    > Perform a test run each time before using. > Never touch the patient and the electrical contacts on the medical device simultaneously. > Keep the medical device (C-NW) away from magnetic fields. > Replace the medical device as soon as the resistance is noticeably reduced.
  • Page 13 Battery (C-NW) > Do not charge the battery unattended. > As soon as the charging cycles start to deteriorate send the medical device to an authorized W&H service partner. > The rechargeable battery cannot be replaced. > Charge the battery of the medical device as soon as the status LED flashes.
  • Page 14 System failure A total system failure does not constitute a critical fault. Simply switch the unit off and then on again. Hygiene and maintenance prior to initial use > Clean and disinfect the medical device. Risks due to electromagnetic fields The functionality of active implantable medical devices (AIMD) (e.g.
  • Page 15 The patient environment (see diagram) encompasses the area up to 2.50 m above the patient and 1.83 m in all horizontal directions. 2,5 m The charger must not be used within the patient environment. 1,83 m 1,83 m...

  • Page 16: Description

    4. Description Foot control C-NW / C-NF C-NW C-NF        Charging LED (orange) Stick   Status LED (green) Reset button   Connection for cable (pairing/charging) Pairing button   Cable (pairing/charging) ...
  • Page 17 Description Status LED foot control C-NW Standby mode > The foot control can be activated by pressing. steady steady GREEN e Connection to paired medical device established ORANGE e Battery is charging...
  • Page 18 Description Status LED foot control C-NW flashes flashes intermittently* GREEN e Foot control is attempting to e Battery is flat establish a connection to the > Charge the battery paired medical device ORANGE * The LED flashes for 40 milliseconds every 4 seconds...

  • Page 19: Start-Up

    5. Start-up Foot Control C-NW Charging the battery Charge the medical device fully before you use them for the first time.  Connect the charging cable into the foot control charging socket.  LED orange: Battery is charging LED off:...
  • Page 20 Start-up Foot Control C-NW Pairing foot control with handpiece drive / control unit Follow the instructions in the handpiece drive / control unit instructions for use. Troubleshooting with pairing problems > Remove any metallic objects located between the foot control and handpiece drive / control unit.

  • Page 21: Hygiene And Maintenance

    6. Hygiene and maintenance General notes Follow your local and national laws, directives, standards and guidelines for cleaning. > Wear protective clothing, safety glasses, face mask and gloves. Cleaning agents and disinfectants > Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants.
  • Page 22 > Use disinfectants which have been tested and found effective by, for example: the Verbund für Angewandte Hygiene e.V. (VAH = Association for Applied Hygiene), the Österreichischen Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) or the U.S.

  • Page 23: 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 24: Initial Treatment At The Point Of Use

    > Wipe the entire surface of the medical device with disinfectant. > Ensure that no fluids enter the medical device. > The charger (C-NW) must not be connected. Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the...

  • Page 25: Manual Cleaning

    Hygiene and maintenance Manual cleaning > Do not place the medical device in liquid disinfectant or in an ultrasonic bath. > Do not immerse the medical device in water or clean them under running water. Evidence of the medical device’s basic suitability for effective manual cleaning was provided by an independent test laboratory using tap water <...

  • Page 26: 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 27: Automated Cleaning And Disinfection

    Hygiene and maintenance Automated cleaning and disinfection > The medical device is not approved for automated processing in a washer-disinfector and sterilization.

  • Page 28: Inspection, Maintenance And Testing

    Hygiene and maintenance Inspection, Maintenance and Testing > Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. > Reprocess any medical devices that are still soiled.

  • Page 29: Servicing

    7. 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. Repairs and returns In the event of operating malfunctions immediately contact an authorized W&H service partner.

  • Page 30: Accessories, Consumables, Spare Parts And Other Recommended Medical Devices By W&H

    8. Accessories, consumables, spare parts and other recommended medical devices by W&H Use only original W&H accessories and spare parts or accessories approved by W&H. Supplier: W&H partners 08014700 Cable (pairing/charging) 08111900 Charging cable 07969610 Charger incl. adaptor...

  • Page 31: Technical Data

    9. Technical data Foot control C-NW C-NF Battery type: Li-ion – Runtime: approx. 2 months – Standby: automatically if not actuated – Charging time: approx. 3 h – Rated voltage: 3.7 V – Rated capacity: 680 mAh – Dimensions (WxDxH): 117 x 117 x 38 mm 102 x 106.5 x 26.5 mm...
  • Page 32 Modulation: GFSK Channels: 40 channels with 2 MHz spacing Ambient conditions Temperature during storage and transport (C-NW): -20°C to +60°C (-4°F to +140°F) Temperature during storage and transport (C-NF): -40°C to +70°C (-40°F to +158°F) Humidity for storage and transport:...
  • Page 33 IEC 60601-1/ANSI/AAMI ES 60601-1 Charger: Class II medical electrical equipment (protective earth conductor used for functional earth connection only!) The medical device (C-NW) is protected against vertically falling drops of water (IPX1 as per IEC 60529). Pollution level: Overvoltage category:...

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

    10. 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 RF communication equipment 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 Results of the electromagnetic tests Electrical fast transients / bursts Mains supply: ±2 kV IEC/EN 61000-4-4 Surges IEC/EN 61000-4-5 ±1 kV L – N ±2 kV L – PE ±2 kV L – PE Conducted disturbances induced by RF fields IEC/EN 61000-4-6 6 V in ISM bands and in amateur radio bands Power frequency magnetic fields IEC/EN 61000-4-8...

  • Page 38: Disposal

    11. 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 W&H medical device has been manufactured with great care by highly qualified specialists. A wide variety of tests and controls guarantees 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 W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 51032 AEN t +43 6274 6236-0, f +43 6274 6236-55 Rev. 002 / 15.02.2024 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

C-nf303160003031600204717300

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