Welch Allyn KleenSpec 790 Series Manual

KleenSpec
®
790 Series
Cordless Illumination System
for the 590 Series Vaginal Speculum
Directions for Use
79910
REF

ii
Copyright 2007 Welch Allyn. All rights are reserved. No one is permitted to
reproduce or duplicate, in any form, this manual or any part thereof without
permission from Welch Allyn.
Caution: Federal US law restricts sale of the device identified in this manual to, or
on the order of, a licensed physician.
Welch Allyn assumes no responsibility for any injury, 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 indications for use published in this
manual.
Welch Allyn and KleenSpec are registered trademarks of Welch Allyn. CaviWipe is
a registered trademark of Metrex Research Corporation.
Caution: Changes or modifications not expressly approved by Welch Allyn could
void the purchaser's authority to operate the equipment.
Patents pending.
Mat. Number: 707021, Ver: D
Welch Allyn
4341 State Street Road, PO Box 220
Skaneateles Falls, NY 13153-0220
www.welchallyn.com
Printed in USA

iii
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
User profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Using the system safely . . . . . . . . . . . . . . . . . . . . . . . . 4
Utilisation sécuritaire du système . . . . . . . . . . . . . . . . . 6
Charging the illuminator . . . . . . . . . . . . . . . . . . 8
Using the illuminator for a pelvic exam. . . . . . 9
Using the illuminator as light source . . . . . . . . 9
Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Cleaning and disinfecting. . . . . . . . . . . . . . . . . . . . . . . 10
Inspecting the system . . . . . . . . . . . . . . . . . . . . . . . . . 11
Recycling the system components . . . . . . . . . . . . . . . 11
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . 12
Contacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Part numbers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Limited warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Service policy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
EMC guidance and manufacturer’s declarations . . . . . 18

iv

Directions for use Cordless illumination system 1
Introduction
The Welch Allyn KleenSpec®790 series cordless illumination
system can be used with or without the KleenSpec 590 series
disposable vaginal speculum. The cordless illumination system
consists of the following items.
Intended use
When used with the vaginal speculum, the cordless illuminator
provides illumination during pelvic examinations and other
gynecological procedures, such as pap smears, dilation and
curettage (D&C) biopsy, and electrosurgery.
The cordless illuminator can be used independent of the
speculum as a general-purpose light source.
Contraindications
The 790 series illuminator (either by itself or in conjunction with a
590 series speculum) is not intended to be used for eye
examinations.
The 790 series illuminator (either by itself or in conjunction with a
590 series speculum) is not intended to be used for diagnosis.
Cordless
illuminator
Charging station
(base and power cord)
Auxiliary power cord
(optional)

2Welch Allyn
User profile
The intended users of the illuminator are medical professionals
who are qualified to perform a pelvic examination.
Symbols
The symbols illustrated on the following pages may appear in this
manual or on the illuminator, charging station, auxiliary power
cord, packaging, or shipping container.
Table 1. Documentation symbols
WARNING In this manual, this symbol and “WARNING” indicate
conditions or practices that could lead to illness, injury,
or death.
Caution In this manual, this symbol and “Caution” indicate
conditions or practices that could damage the
equipment or other property.
On the product, this symbol means consult
accompanying documentation.
Table 2. Shipping, storing, and environment symbols
This end up Keep dry
Fragile Relative humidity limit
Temperature limits
-20°C
+49°C

Directions for use Cordless illumination system 3
Table 3. Certification symbols
Meets essential requirements of European Medical Device Directive
93/42/EEC.
European Regulatory Manager
Welch Allyn LTD.
Navan Business Park, Dublin Road
Navan, County Meath, Republic of Ireland
Tel.: [phone]
Fax: [phone]
Complies with applicable U.S. and Canadian medical safety standards.
EMC framework of Australia
Table 4. Operation symbols
Warning, LED beam
Caution, hot surface
Type BF applied part
Alternating current
Direct current
Double insulation
Not protected from the ingress of liquid.
Recycle the product separately from other disposables. See “Recycling
the system components” on page 11.
Power plug
EC REP
US
C
166292
N344
IPXØ

4Welch Allyn
Using the system safely
Before using the cordless illumination system, you must read and
understand the following safety-related information.
General warnings
The following warning statements apply to use of the cordless
illumination system in general. Warning statements that apply
specifically to particular procedures, such as cleaning, appear in
the corresponding sections of the manual.
Warning statements indicate conditions or practices that could
lead to illness, injury, or death.
WARNING LED radiation. Class 2 LED product. To avoid eye injury, do
not stare into beam.
WARNING The illuminator may generate heat after prolonged use.
•Operation time limits: Illuminator with speculum ≤10 minutes on,
≥5 minutes off between uses. Illuminator alone ≤2 minutes on,
≥5 minutes off between uses.
•Illuminator could be harmful to skin if touched after being on for
extended times.
•To avoid fire, do not place illuminator onto a flammable surface if
LED is on.
•Illuminator is not suitable for use in the presence of a flammable
anesthetic mixture with air or oxygen or nitrous oxide. An
explosion may result.
WARNING To prevent shock hazards, the power outlet must be
properly grounded. Grounding reliability is achieved only when
connected to hospital-use or hospital-grade receptacles.
WARNING The illuminator is not intended to be used for eye
examinations.
WARNING The illuminator is not intended to be used for diagnosis.
WARNING The illuminator is intended to be used by trained medical
professionals.

Directions for use Cordless illumination system 5
General cautions
The following caution statements apply to use of the cordless
illumination system in general. Caution statements that apply
specifically to particular procedures, such as pelvic examinations,
appear in the corresponding sections of the manual.
Caution statements indicate conditions or practices that could
damage the equipment or other property.
WARNING This product comes with a power supply and/or
power cord that is intended for use only with this product.
The power supply and/or power cord have not been tested and
approved for use with other products that may have the same
power connectors. If you cannot locate the original power
supply and/or power cord, please contact Welch Allyn to obtain
replacement parts.
Caution The cordless illuminator could be a biohazard after
use. Follow good hospital practices. See “Cleaning and
disinfecting” on page 10.
Caution Cordless illuminator, charging station, and auxiliary
power cord are not protected from the ingress of liquid.
Caution There are no user-serviceable parts inside the
device. In case of a malfunction, call Welch Allyn and precisely
describe the problem.
Caution This device complies with current required
standards for electromagnetic interference and should not
present problems to other equipment or be affected by other
devices. As a precaution, avoid using this device in close
proximity to other equipment.
Caution Use only Welch Allyn-approved parts. See “Part
numbers” on page 15.

6Welch Allyn
Utilisation sécuritaire du système
Avant d'utiliser le système d’éclairage sans fil, vous devez bien lire et
comprendre les renseignements de sécurité suivants.
Avertissements généraux
Les avertissements suivants s’appliquent à l'utilisation du système
d’éclairage sans fil en général. Les avertissements qui s'appliquent à des
procédures particulières, comme le nettoyage, sont abordés dans les
sections correspondantes de ce manuel.
Ces avertissements indiquent des conditions ou des pratiques qui
pourraient causer des maladies, des blessures ou des décès.
AVERTISSEMENT Rayonnement de la DEL. Produit DEL de classe 2.
Pour éviter les blessures aux yeux, ne regardez pas directement le
faisceau lumineux.
AVERTISSEMENT Le système d’éclairage peut dégager de la chaleur
après une utilisation prolongée.
•Les durées d'opération maximales : Illuminateur avec spéculum
≤10 minutes de marche, ≥5 minutes d’arrêt entre les utilisations.
Illuminateur seul ≤2 minutes de marche, ≥5 minutes d’arrêt entre
les utilisations.
•Le système d’éclairage peut causer des brûlures cutanées si vous
y touchez après une utilisation prolongée.
•Pour éviter les risques d'incendie, ne déposez pas le système
d’éclairage sur une surface inflammable lorsque la DEL est
allumée.
•Le système d’éclairage ne devrait pas être utilisé en présence
d'un mélange d'anesthésique inflammable et de l’air ou encore
d'oxygène ou d'oxyde nitreux. Cela pourrait causer une explosion.
AVERTISSEMENT La prise électrique doit être correctement mise à
la terre afin d’éviter les chocs électriques. Vous ne pouvez être certain
de la mise à la terre que si l'appareil est branché dans une prise utilisée
par les hôpitaux ou de qualité hospitalière.
AVERTISSEMENT Le système d’éclairage ne devrait pas être utilisé
pour les examens des yeux.
AVERTISSEMENT Le système d’éclairage ne devrait pas être utilisé
pour effectuer un diagnostic.
AVERTISSEMENT Le système d’éclairage est conçu pour être utilisé
par des professionnels médicaux formés.