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

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© 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

4Directions for use Welch 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 To avoid the risk of electric shock, this equipment
must only be connected to a supply mains with protective
earth.
WARNING No modification to this equipment is allowed.
WARNING The illuminator may generate heat after prolonged
use. For operation time limits, see “Intermittent operation” on
page 13.
•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.

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 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.
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.

6Directions for use Welch Allyn
Caution Disconnect the AC power cord to remove power to
the device.
Caution The cordless illuminator could be a biohazard after
use. Follow good hospital practices. See “Cleaning and
disinfecting” on page 9.
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 14.

Directions for use Cordless illumination system 7
Charging the illuminator
Charge the illuminator before using it the first time, or whenever
its low-charge indicator turns on.
To charge the illuminator
1. If LED is lit, turn power switch off.
2. Connect charging base to AC power.
3. Place the illuminator (either direction) into the charging
station. Full charging takes 6 to 8 hours.
4. Remove the charged illuminator when you are ready to use it.
It is safe to leave the illuminator in the charging station after it
is charged.
Low-charge indicator:
On = battery low
Power switch
LED
Status indicator:
Off = no AC power
Green = AC power
Amber (illuminator inserted) = charging.
Full charging takes 6 to 8 hours.

8Directions for use Welch Allyn
Using the illuminator for a pelvic exam
Using the illuminator as light source
To use the illuminator as a light source,
slide the power switch to turn it on (all the
way down) and off (all the way up).
1. Fully insert the illuminator into a 590
series speculum (a). The LED
automatically turns on.
2. Conduct the examination.
3. If the LED turns off, do not remove the
speculum. Do either of these things:
• Leave the illuminator in place, and
use an external light source.
or
• Connect the auxiliary power cord
to AC power. Hold the speculum in
place, and remove the illuminator.
Connect the auxiliary power cord to
illuminator (b). Reinsert the
illuminator.
4. When finished, remove the speculum,
and then remove the illuminator. The
LED automatically turns off.
a
b
Note For operation time limits, see
“Intermittent operation” on page 13”.
Power
switch