Welch Allyn KleenSpec 800 Directions For Use 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

Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA

www.welchallyn.com

This manual applies to 901070 VAGINAL SPECULUM LIGHTING SYSTEM.

Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park
Dublin Road
Navan, County Meath
Republic of Ireland

Contents

Introduction ............................................................................................. 1

Use and maintain the illuminator .......................................................... 5

iii

Intended use ........................................................................................................ 1

Contraindications ................................................................................................. 1

Symbols ............................................................................................................... 1

Warnings and cautions ......................................................................................... 3

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

iv Contents Welch Allyn®KleenSpec 800 Series Cordless Illumination System

Introduction

Intended use

When used with the KleenSpec
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.

®

Disposable Vaginal Speculum (vaginal speculum),

1

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.

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.

Keep dry

Non-ionizing electromagnetic
radiation

Global Trade Item Number Consult Directions for use

2 Introduction Welch Allyn®KleenSpec 800 Series Cordless Illumination System

Symbol Description Symbol Description

For use by or on the order of a
licensed medical professional

Manufacturer Fragile

Separate collection of Electrical
and Electronic Equipment. Do not
dispose as unsorted municipal
waste.

Reorder number Humidity limitation

Product Identifier Recyclable

Authorized Representative in the
European Community

This way up

Temperature limit

Meets essential requirements of
the European Medical Device
Directive 93/42/EC

Lot code

Li-ion

Approved for use in Japan Type BF applied part when used

Rechargeable battery

with the KleenSpec Disposal
Vaginal Speculum

Directions for use Introduction 3

Warnings and cautions

WARNING Patient injury risk. No modifications to the illuminator is
allowed. Modification of the illuminator could be hazardous to patients and
personnel.

WARNING Patient injury risk. This device comes with a power supply and/
or power cord that is intended for use only with this device. 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:
obtain replacement parts.

WARNING Patient injury risk. KleenSpec Cordless Illumination System is
not suitable for use in the presence of a flammable anesthetic mixture with
air, oxygen, or nitrous oxide. An explosion may result.

CAUTION Disconnect the AC power cord from the charger to the mains
outlet to remove power to the device.

www.welchallyn.com/about/company/locations.htm to

CAUTION The charging station and power cord are not protected from the
ingress of liquid.

CAUTION Do not position any part of the illumination system in any way
that makes it difficult to disconnect AC power from the device. To remove
all AC power from the illumination system, unplug the external power
supply from the mains outlet.