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

Symbol Description Symbol Description
For use by or on the order of a
licensed medical professional
This way up
Manufacturer Fragile
Separate collection of Electrical
and Electronic Equipment. Do not
dispose as unsorted municipal
waste.
Temperature limit
Reorder number Humidity limitation
Product Identifier Recyclable
Authorized Representative in the
European Community
Meets essential requirements of
the European Medical Device
Directive 93/42/EC
Lot code
Li-ion
Rechargeable battery
Approved for use in Japan Type BF applied part when used
with the KleenSpec Disposal
Vaginal Speculum
2Introduction Welch Allyn®KleenSpec 800 Series Cordless Illumination System

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: www.welchallyn.com/about/company/locations.htm to
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.
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.
Directions for use Introduction 3

4Introduction Welch Allyn®KleenSpec 800 Series Cordless Illumination System

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.
Note It is safe to leave the illuminator in the charging station after it is charged.
The charging base has the following status indicators.
Status Description
Off No AC power
Green AC power / Full charge
Amber Illuminator inserted into charging base and is charging
5

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.
3. Complete the examination.
4. When the examination is completed, remove the speculum and press the power
button to turn off the illuminator.
5. Remove the illuminator from the speculum.
Clean and disinfect
The following are approved wipes for cleaning and disinfecting.
•CaviWipes®
•Super Sani-Cloth®
• 70% isopropyl alcohol
Clean and disinfect the illuminator
Following are directions for cleaning and intermediate disinfecting of the illuminator.
1. Clean the illuminator.
a. Following the wipe manufacturer's instructions, wipe the entire illuminator to
remove any visible debris.
b. Discard used wipe appropriately.
2. Disinfect the illuminator (intermediate level).
a. Follow wipe label instructions for appropriate contact times.
b. Discard used wipe appropriately.
Clean the charging base
1. Unplug the power cord.
2. Use an approved wipe to remove visible debris.
3. Discard used wipe appropriately.
6Use and maintain the illuminator Welch Allyn®KleenSpec 800 Series Cordless Illumination System