W&H S-NW Instructions For Use Manual

W&H S-NW Instructions For Use Manual

Foot control variable

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Instructions for Use
Foot control
variable
S-NW, S-N2, S-N1

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Table of Contents
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Summary of Contents for W&H S-NW

  • Page 1 Instructions for Use Foot control variable S-NW, S-N2, S-N1...
  • Page 2: Table Of Contents

    Scope of delivery ......................................11 4. Safety notes ......................................12 5. Attaching - detaching the locator ................................15 6. Foot control S-NW ....................................16 Inserting and replacing batteries ..............................16 Replacing the O-ring .....................................17 Connecting and disconnecting the CAN dongle ..........................18 Description of CAN dongle ..................................
  • Page 3: Symbols

    Symbols in the Instructions for Use WARNING! ATTENTION! General explanations, (if persons could be injured) (if property could be damaged) without risk to persons or property Foot control...
  • Page 4 Symbols on the foot control S-NW CE marking Non-ionizing electromagnetic Catalogue number with identification number radiation XXXX of the Notified Body Battery compartment closed Serial number Do not dispose of with domestic waste Battery compartment open Date of manufacture Data Matrix code...
  • Page 5 Symbols on the foot control S-N2 / S-N1 CE marking Catalogue number with identification number XXXX of the Notified Body Do not dispose of with Serial number domestic waste Data Matrix code Date of manufacture for product information including UDI (Unique Device Identification) Category AP equipment UL Component Recognition...
  • Page 6 Symbols on the packaging CE marking Data Matrix code with identification number for product information including UDI XXXX of the Notified Body (Unique Device Identification) This way up Data structure in accordance with Health Industry Bar Code Fragile, handle with care Permitted temperature range +70 °C (+158°F) Max.
  • Page 7: Introduction

    1. Introduction For your safety and the safety of your patients These Instructions for Use explain how to use your product. 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. Observe the safety notes.
  • Page 8 Production according to EU Directive The foot control S-N1 and S-N2 is a medical device as defined by EU Directive 93/42/EEC. The foot control S-NW is a medical device as defined by EU Directive 93/42/EEC and RED Directive 2014/53/EU. Responsibility of the manufacturer...
  • Page 9: Electromagnetic Compatibility (Emc)

    2. Electromagnetic compatibility (EMC) Medical electrical equipment is subject to particular precautions in regard to EMC and must be installed and put into operation in accordance with the EMC notes included. W&H guarantees the compliance of the device with the EMC requirements only when used with original W&H accessories and spare parts.
  • Page 10: Scope Of Delivery

    3. Scope of delivery Foot control Incl. dongle Compatible with control unit* Implantmed SI-1010, Implantmed SI-1015, Implantmed SI-1023 S-NW, REF 30264000 REF 07759700 Amadeo Medical M-UK 1023, M-UK1015, M-UK1010 S-NW, REF 30264001 REF 07795800 Piezomed SA-320, Elcomed SA-310, Implantmed REF 16929000 / 16929001...
  • Page 11: Scope Of Delivery

    Scope of delivery Foot control S-NW 3 disposable batteries AA / Mignon / LR6 / 1.5V * Not included...
  • Page 12: Safety Notes

    4. Safety notes General > Before using the foot control for the first time, store it at room temperature for 24 hours. > Check the foot control for damage and loose parts before every use. > Do not use the foot control if it is damaged. >...
  • Page 13 Safety notes General Risks due to electromagnetic fields The functionality of implantable systems, such as cardiac pacemakers and ICD (implantable cardioverter defibrillator) 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 14 Safety notes Foot control S-NW Keep the ORANGE button depressed and switch between the control units. Disposable batteries > Replace the disposable batteries at the first prompt (battery icon on display or LED on dongle). > Replace batteries outside explosive atmospheres only.
  • Page 15: Attaching - Detaching The Locator

    5. Attaching - detaching the locator Attaching and detaching the locator > Push it right in until the locator reaches the stop. > Pull the locator out.
  • Page 16: Foot Control S-Nw

    6. Foot control S-NW Inserting and replacing batteries Open battery compartment Remove batteries  Open the battery compartment.  Pull the red thread to remove the batteries. Note the symbols! Insert batteries Lock battery compartment Reposition the red thread before  Lock the battery compartment.
  • Page 17: Replacing The O-Ring

    Foot control S-NW Replacing the O-ring Do not use sharp tools!  Firmly squeeze the O-ring between your thumb and index finger so that it forms a loop.  Pull off the O-ring.  Push the new O-ring on in its place.
  • Page 18: Connecting And Disconnecting The Can Dongle

    Foot control S-NW Connecting and disconnecting the CAN dongle Connecting CAN dongle  Plug in the CAN dongle. Pay attention to the positioning! Removing CAN dongle  Press the side lock and remove the CAN dongle.
  • Page 19: Description Of Can Dongle

    Press and hold the green, orange and yellow buttons simultaneously on the foot control S-NW for at least three seconds. Using multiple W&H control units simultaneously Press and hold the orange button on the foot control S-NW for 3 seconds to switch between the various control units.
  • Page 20: Connecting And Disconnecting The Spi Dongle

    Foot control S-NW Connecting and disconnecting the SPI dongle Connecting and disconnecting the SPI dongle Pay attention to the positioning!  Plug in the SPI dongle or disconnect the SPI dongle from the control unit.  Attach the SPI dongle to the irrigant support or remove the SPI dongle from the irrigant support.
  • Page 21: Description Of Spi Dongle

    Press and hold the green, orange and yellow buttons simultaneously on the foot control S-NW for at least three seconds. Using multiple W&H control units simultaneously Press and hold the orange button on the foot control S-NW for 3 seconds to switch between the various control units.
  • Page 22: Assistance With Pairing Problems

    Foot control S-NW Assistance with pairing problems > Check the plug-in connection of the dongle. > Remove metallic objects between foot control, control unit and dongle. > Change the position of the foot control. > Eliminate any sources of interference (e.g. brush motors, mobile telephones, radios, WLAN, ...).
  • Page 23: Foot Control S-N2 / S-N1

    7. Foot control S-N2 / S-N1 Connecting / disconnecting Pay attention to the positioning!  Plug in the foot control S-N2 / S-N1 or disconnect the foot control from the control unit.
  • Page 24: Hygiene And Maintenance

    8. 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. > The foot control is sealed and may be wiped clean. > The foot control is not approved for automated cleaning (thermo washer disinfector) and sterilization. >...
  • Page 25: Servicing

    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. > Always return equipment in the original packaging > Foot control S-NW: Remove the batteries.
  • Page 26: W&H Accessories And Spare Parts

    10. 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 (Link: https://www.wh.com) 07759700 07795800 04653500 CAN dongle SPI dongle Locator for foot control 07823400 O-ring...
  • Page 27: Technical Data

    11. Technical data Foot control S-NW S-N2 / S-N1 Power supply: 3 disposable batteries – AA / Mignon / LR6 / 1,5V Dimensions in mm (height x width x depth): 154 x 202 x 210 156 x 207 x 206...
  • Page 28 IEC 60601-1/ANSI/AAMI ES 60601-1 S-NW / S-N2 / S-N1 are approved for operation in potentially explosive atmospheres. S-NW / S-N2 / S-N1 are waterproof according to IPX8, 1 m depth of immersion, 1 hour (water-tight in accordance with IEC 60529)
  • Page 29: Disposal

    12. Disposal Ensure that the parts are not contaminated on disposal. Follow your local and country-specific laws, directives, standards and guidelines for disposal. > Medical device > Waste electrical equipment > Packaging...
  • Page 30: Explanation Of Warranty Terms

    Ex p lana ti on o f warra nty te rms This W&H product 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 31: Authorized W&H Service Partners

    Authorized W&H service partners Visit W&H on the Internet at http://wh.com You can find your nearest authorized W&H service partner under “Service” in the menu. If you do not have Internet access, please contact: W&H (UK) LIMITED, 6 Stroud Wood Business Centre, Park Street, St Albans, Hertfordshire AL2 2NJ, United Kingdom t + 44 1727 874990, f + 44 1727 872254, E-Mail: technical.uk@wh.com W&H Impex Inc., 6490 Hawthorne Drive, Windsor, Ontario, N8T 1J9, Canada t + 1 800 2656277, 1 519 9446739, f + 1 519 9746121, E-Mail: service.ca@wh.com...
  • Page 32: Manufacturer's Declaration

    Manufacturer’s declaration...
  • Page 33 Manufacturer’s declaration...
  • Page 34 Manufacturer’s declaration...
  • Page 35 Manufacturer’s declaration...
  • Page 36 Manufacturer W&H Dentalwerk Bürmoos GmbH Ignaz-Glaser-Straße 53, 5111 Bürmoos, Austria Form-Nr. 50882 AEN t + 43 6274 6236-0, f + 43 6274 6236-55 Rev. 005 / 02.08.2019 office@wh.com wh.com Subject to alterations...

This manual is also suitable for:

S-n2S-n1

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