Welch Allyn KleenSpec 790 Series Manual

KleenSpec®790 Series
Cordless Illumination System
for the 590 Series Vaginal Speculum
Directions for use...........................................1
Mode d’emploi (Français)...................................23
Instrucciones de uso (Español) ..............................39
Instruções de utilização (Português) .........................55
Gebrauchsanleitung (Deutsch) ..............................71
Gebruikshandleiding (Nederlands) ...........................87
Brugsanvisning (Dansk) ...................................103
Istruzioni per l'uso (Italiano)................................119
Bruksanvisning (Svenska) .................................137
Brukerhåndbok (Norsk)....................................153
:VND]µZNLGRW\F]ÇFHXľ\WNRZDQLD3ROVNL ............ 169
Käyttöohjeet (Suomi) ......................................185
ˍˡˤˠ˜ˢ˯˴ˮ˛˰ˤ˯˃˨˨ˤ˪˦˧˙ ................................201
79910
REF

ii
© 2012 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.
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: 718914, Ver: A
Welch Allyn
4341 State Street Road, PO Box 220
Skaneateles Falls, NY 13153-0220
www.welchallyn.com
Printed in USA

1
Directions for use
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

2Directions for use Welch 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.
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 operating
instructions.
Shipping, storing, and environment symbols
This end up Keep dry
Fragile Relative humidity limit
Temperature limits
95%
15%
-20C
+49C

Directions for use Cordless illumination system 3
Certification symbols
Meets essential requirements of European Medical Device Directive
93/42/EEC.
Regulatory Affairs Representative
Welch Allyn Limited
Navan Business Park, Dublin Road
Navan, County Meath, Republic of Ireland
CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1
CONFORMS TO: IEC 60601-1, IEC60601-1-2, UL 60601-1
EMC framework of Australia
Operation symbols
Caution, hot surface
The speculum is a 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 10.
Power plug
EC REP
N344
IPXØ