Welch Allyn KleenSpec 800 Series Directions For Use Manual

Cordless illumination system
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Welch Allyn
KleenSpec 800 Series
Cordless Illumination System
Directions for use

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Summary of Contents for Welch Allyn KleenSpec 800 Series

  • Page 1 ® Welch Allyn KleenSpec 800 Series Cordless Illumination System Directions for use...
  • Page 2 © 2018 Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn.
  • Page 3: Table Of Contents

    Contents Introduction ..................... 1 Intended use ......................1 Contraindications ....................1 Symbols ....................... 1 Warnings and cautions ..................3 Use and maintain the illuminator ............5 Charge the illuminator ..................5 Use the illuminator for a pelvic examination ............6 Clean and disinfect ....................
  • Page 4 ® iv Contents Welch Allyn KleenSpec 800 Series Cordless Illumination System...
  • Page 5: Introduction

    When used with the KleenSpec Disposable Vaginal Speculum (vaginal speculum), ® Welch Allyn KleenSpec 800 Series Cordless Illumination System (the illuminator) provides illumination during pelvic examinations and other gynecological procedures, such as pap smears, dilation and curettage (D&C) biopsy, and electrosurgery. Contraindications ®...
  • Page 6 ® 2 Introduction Welch Allyn KleenSpec 800 Series Cordless Illumination System Symbol Description Symbol Description For use by or on the order of a This way up licensed medical professional Manufacturer Fragile Separate collection of Electrical Temperature limit and Electronic Equipment. Do not dispose as unsorted municipal waste.
  • Page 7: Warnings And Cautions

    The power supply or power cord have not been tested and approved for use with other devices that may have the same power connectors. If you cannot locate the original power supply and/or power cord, contact Welch Allyn Technical Support: www.welchallyn.com/about/company/locations.htm obtain replacement parts.
  • Page 8 ® 4 Introduction Welch Allyn KleenSpec 800 Series Cordless Illumination System...
  • Page 9: Use And Maintain The Illuminator

    Use and maintain the illuminator Charge the illuminator Charge the illuminator before using it the first time. 4-5 hr 1. Connect the charging base to AC power. 2. Place the illuminator (either direction) into the charging station. 3. Remove the charged illuminator when you are ready to use it. Full charging takes 4 to 5 hours.
  • Page 10: Use The Illuminator For A Pelvic Examination

    ® 6 Use and maintain the illuminator Welch Allyn KleenSpec 800 Series Cordless Illumination System Use the illuminator for a pelvic examination 1. Fully insert the illuminator into a KleenSpec Disposable Vaginal Speculum (in either direction). 2. Press the power button on the illuminator.
  • Page 11: Inspect The System

    1. Examine all components of the cordless illumination system regularly. Components include the illuminator and charging base. 2. If any component is worn or damaged, replace it with a Welch Allyn-approved part. For ordering information, contact your local Welch Allyn representative:...
  • Page 12 ® 8 Use and maintain the illuminator Welch Allyn KleenSpec 800 Series Cordless Illumination System...
  • Page 13: Appendices

    Appendices Appendix A: Specifications Charging station power supply classification: US, Canada, & International; Class I and internally powered Characteristic Specification Input 100-240v / 50-60Hz 160-80 mA Output 5v DC 1400 mA Category Not AP/APG Equipment Physical specifications Characteristic Specification Illuminator 1.96 W x 1.37 D x 3.74 H in;...
  • Page 14 ® 10 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Environment (temperature and humidity) Characteristic Specification Operating +10°C (50°F) and +35°C (95°F) 700 hPa - 1060 hPa 30% - 75% non-condensing Transport/Storage –20°C (-4°F) and +49°C (120°F) 500 hPa - 1060 hPa...
  • Page 15: Appendix B: Accessories

    Directions for use Appendices 11 Appendix B: Accessories Part number Description Illustration 80000 KleenSpec Vaginal Speculum Cordless Illuminator 80010 KleenSpec Vaginal Speculum Cordless Illuminator with Charging Station/Domestic 4-5 hr 80015 KleenSpec Vaginal Speculum Cordless Illuminator with Charging Station/ International 74010 KleenSpec Charging Station/Domestic 74015 KleenSpec Charging Station/International...
  • Page 16: Appendix C: Emc Guidance And Manufacturer's Declarations

    Emissions and immunity information Electromagnetic emissions The Welch Allyn KleenSpec 800 Series is intended for use in the electromagnetic environment specified below. The customer or user of the 800 Series should assure that it is used in such an environment.
  • Page 17 Directions for use Appendices 13 Electromagnetic emissions RF emissions Class B The 800 Series is suitable for use in all establishments, including CISPR 11 domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.
  • Page 18 ® 14 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Electromagnetic immunity 70 % U ; 25/30 cycles 70 % U ; 25/30 cycles Single phase: at 0° 0 % U ; 250/300 cycle 0 %U ; 250/300 cycle...
  • Page 19 Directions for use Appendices 15 Electromagnetic immunity The 800 Series is intended for use in the electromagnetic environment specified below. The customer or the user of the 800 Series should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance...
  • Page 20 ® 16 Appendices Welch Allyn KleenSpec 800 Series Cordless Illumination System Recommended separation distances between portable and mobile RF communications equipment and the 800 Series The 800 Series is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
  • Page 21 Directions for use Appendices 17 Test specifications for enclosure port immunity to RF wireless communications equipment iDEN 820, CDMA 850, LTE Band 5 1720 1700 - 1990 GSM 1800; Pulse modulation CDMA 1900; 217 Hz GSM 1900; 1845 DECT; LTE Band 1, 3, 4, 25;...
  • Page 22: Appendix D: Limited Warranty

    KleenSpec 800 Series Cordless Illumination System Appendix D: Limited warranty Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with manufacturer's specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents.

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