Welch Allyn KleenSpec 800 Series Manual

Welch Allyn®KleenSpec 800 Series
Cordless Illumination System
Directions for use

© 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. Welch Allyn assumes no responsibility for any injury to anyone, or for
any illegal or improper use of the product, that may result from failure to use this product in accordance with the
instructions, cautions, warnings, or statement of intended use published in this manual.
For patent information, please visit www.welchallyn.com/patents.
For information about any Welch Allyn product, contact your local Welch Allyn representative: www.welchallyn.com/
about/company/locations.htm.
DIR 80021345 Ver. C
Revised 2018-07 This manual applies to 901070 VAGINAL SPECULUM LIGHTING SYSTEM.
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallyn.com
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland

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 ............................................................................................... 6
Inspect the system .............................................................................................. 7
Appendices .............................................................................................. 9
Appendix A: Specifications .................................................................................. 9
Appendix B: Accessories ................................................................................... 11
Appendix C: EMC guidance and manufacturer’s declarations ........................... 12
Appendix D: Limited warranty ........................................................................... 18
iii

iv Contents Welch Allyn®KleenSpec 800 Series Cordless Illumination System

Introduction
Intended use
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
The illuminator (either by itself or in conjunction with a KleenSpec®vaginal speculum) is
not intended to be used for eye examinations.
The illuminator (either by itself or in conjunction with a KleenSpec vaginal speculum) is
not intended to be used for diagnosis.
Symbols
The symbols illustrated on the following pages may appear in this Directions for use or
on the 800 Series Cordless Illuminator (illuminator) or charging station.
Symbol Description Symbol Description
WARNING The warning
statements in this manual
identify conditions or practices
that could lead to illness, injury,
or death.
In a black and white document,
this symbol appears with a grey
background.
Keep dry
CAUTION The caution
statements in this manual
identify conditions or practices
that could result in damage to
the equipment or other property,
or loss of data.
Non-ionizing electromagnetic
radiation
Global Trade Item Number Consult Directions for use
1