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.

Directions for use Cordless illumination system 7
Mises en garde générales
Les mises ne garde suivantes s’appliquent à l'utilisation du
système d’éclairage sans fil en général. Les énoncés de mise en
garde qui s'appliquent à des procédures particulières, comme
les examens pelviens, sont abordées dans les sections
correspondantes de ce manuel.
Les énoncés de mise en garde indiquent des conditions ou des
pratiques qui pourraient endommager les équipements ou la
propriété.
AVERTISSEMENT Un bloc d'alimentation et/ou un cordon
d'alimentation, destinés à une utilisation avec ce produit
seulement, sont fournis avec le produit. Le bloc d'alimentation et/
ou le cordon d'alimentation n'ont pas été testés et approuvés pour
une utilisation avec d'autres produits qui pourraient être munis des
mêmes connecteurs d'alimentation. Si vous n'avez plus le bloc
d'alimentation et/ou le cordon d'alimentation originaux, veuillez
communiquer avec Welch Allyn pour obtenir des pièces de
remplacement.
Mise en garde Le système d’éclairage sans fil pourrait être
considéré à risque biologique après utilisation. Conformez-vous
aux bonnes pratiques hospitalières. Voir “Cleaning and
disinfecting” à la page 10.
Mise en garde Le système d’éclairage sans fil, la borne de
recharge et le cordon d'alimentation auxiliaire ne sont pas
protégés contre les infiltrations de liquide.
Mise en garde Cet appareil ne contient aucune pièce à
entretenir. En cas de mauvais fonctionnement, appelez Welch
Allyn et décrivez le problème de manière précise.
Mise en garde Cet appareil est conforme aux normes actuelles
obligatoires sur les interférences électromagnétiques. Il ne devrait
présenter aucun problème pour les autres équipements et ne
devrait pas être affecté par d'autres appareils. Par mesure de
précaution, évitez d'utiliser cet appareil à proximité d'autres
équipements.
Mise en garde N'utilisez que des pièces approuvées par Welch
Allyn. Voir “Part numbers” à la page 15.

8Welch Allyn
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 (no illuminator) = AC power
Amber (illuminator inserted) = charging
Green (illuminator inserted) = charged

Directions for use Cordless illumination system 9
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 15.
Power
switch

10 Welch Allyn
Maintenance
Cleaning and disinfecting
Use CaviWipe® wipes for both cleaning and disinfecting.*
*EPA-approved intermediate-level disinfectant appropriately labeled as effective against
TB mycobacterium tuberculosis (per AAMI TIR-12, 2004, section 5.2.3)
To clean and disinfect the illuminator
1. After using the illuminator, unplug any power cords.
2. Clean the illuminator.
a. Following the wipe manufacturer's instructions, wipe the entire
unit to completely remove any gross debris.
b. Gently wipe the gold contacts on the bottom with 70% alcohol.
If debris builds up on these contacts, the charging or auxiliary
power functions might be affected.
3. Disinfect the illuminator.
a. Following the wipe manufacturer's instructions, thoroughly wet the
surface of the entire illuminator.
b. Using sterile gauze soaked with 70% isopropyl alcohol, thoroughly
wet the surface of the entire illuminator. The treated surface must
remain wet for five minutes. If needed, reapply the solution to keep
the surface continuously wet during this time.
c. Allow the surface to dry.
To clean the charging base or auxiliary power cord
1. After using the charging base or auxiliary power cord, unplug the power
cord.
2. Clean the component. Following the wipe manufacturer's instructions,
wipe the surface to completely remove any gross debris.
Caution Use only the cleaning and disinfection methods
described in this manual. Clean the illuminator prior to disinfection.

Directions for use Cordless illumination system 11
Inspecting the system
Examine all components of the cordless illumination system
monthly. Components include the illuminator, charging station,
and auxiliary power cord.
If any component is worn or damaged, replace it with the Welch
Allyn-approved part. For ordering information, see “Part
numbers” on page 15.
Recycling the system components
Within the EU
Do not dispose of this product as unsorted municipal waste.
Prepare it for reuse or separate collection as specified by
Directive 2002/96/EC of the European Parliament and the
Council of the European Union on Waste Electronic and
Electrical Equipment (WEEE).
If this product is contaminated, this directive does not apply.
For more specific disposal information, see
www.welchallyn.com/weee, or contact Welch Allyn.
Outside the EU
When the product reaches its end of life, recycle the components
according to national, state, and local regulations, or return the
product to Welch Allyn.

12 Welch Allyn
Troubleshooting
If you try these suggestions and still have problems, contact
Welch Allyn.
Contacts
For information about any Welch Allyn product, call the nearest
Welch Allyn representative:
Problem Probable causes & solutions
LED does not light. Battery is low. Charge the illuminator.
Illuminator is not seated correctly in speculum. Insert
illuminator fully into speculum.
LED does not light when the
auxiliary power cord is
attached.
Auxiliary power cord is not plugged in. Plug the
auxiliary power cord into an AC outlet.
Auxiliary power cord is not seated properly. Plug the
cord into the illuminator properly.
LED does not automatically
turn off when removing the
illuminator from the
speculum.
Power switch is damaged or blocked. Clean the switch
area. If the problem continues, replace the illuminator.
Illuminator does not charge
in the charging base.
Charging base is not plugged in. Connect charging
base to AC power.
Illuminator is not seated properly in charging base.
Reinsert the illuminator into the charging base, and
verify that the status indicator glows amber.
USA 1 800 535 6663
+ 1 315 685 4560
Australia + 6129 638 3000
800 074 793
Canada 1 800 561 8797 China + 86 216 327 9631
European Call Center + 353 46 906 7790 France + 3315 569 5849
Germany + 49 747 792 7186 Japan + 8133 219 0071
Latin America + 1 305 669 9003 Netherlands + 3115 750 5000
Singapore + 656 419 8100 South Africa + 2711 777 7555
United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551

Directions for use Cordless illumination system 13
Appendix
Specifications
Item Specification
Auxiliary power cord transformer
Classification
Input
Output
Category
U.S. & Canada International
Class I, type BF applied part Class II, type BF applied part
120 V ~ 60 Hz 90–264 VAC ~ 50–60 Hz, 200 mA
5 VDC, 300 mA 5 VDC, 300 mA
Not AP/APG equipment Not AP/APG equipment
Charging station transformer
Classification
Input
Output
Category
U.S. & Canada International
Class I Class I, Class II
120 V ~ 60 Hz 230 V (240 V in Australia) ~ 50 Hz
9.8 VDC, 150 mA 7.5 – 9.2 VDC , 200 mA
Not AP/APG equipment Not AP/APG equipment
Power cord length
Auxiliary power cord
Charging station
305 cm (120 in)
92 cm (36 in)
Weight
Illuminator
Charging station (base and
power cord)
Auxiliary power cord
48 g (0.1 lb)
142 g (0.31 lb)
290 g (0.64 lb)
Battery cell
Capacity
Voltage
Chemistry
700 mAh
3.7 V
Li-ion (single lithium ion)
Protection against ingress of
water, per IEC 60529 (illuminator,
auxiliary power cord, charging
station)
IPXØ
Operating conditions
Temperature
Relative humidity
Altitude
+10° C to +35° C (+50° F to +95° F)
30% to 75% noncondensing
700 to 1060 hPa

14 Welch Allyn
Shipping and storage conditions
Temperature
Relative humidity
Altitude
-20° C to +49° C (-4° F to +120° F)
15% to 95% noncondensing
500 hPa to 1060 hPa
Intermittent operation
Illuminator with speculum
Illuminator alone
≤ 10 minutes on, ≥5 minutes off between uses
≤2 minutes on, ≥5 minutes off between uses
Safety, EMC, and regulatory
compliance
CAN/CSA C22.2 No. 601.1-M90, including amendments 1 & 2
EN/IEC 60601-1
EN/IEC 60601-1-2
EN/IEC 60825-1
UL 60601-1
AS/NZS CISPR11
LED radiation output < 6.67 mW at 400 – 700 nm wavelengths
Item (continued) Specification (continued)

Directions for use Cordless illumination system 15
Part numbers
* Specify country and voltage.
Item Order Number
Cordless illuminator system
with charging station
U.S. & Canada: 79910
International: 79915*
Cordless illuminator system
with charging station and
auxiliary power cord
U.S. & Canada: 79920
International: 79925*
Cordless illuminator U.S. & Canada: 79900
Charging station
(base and power cord)
U.S. & Canada: 73910
International: 73915*
Auxiliary power cord U.S. & Canada: 75910
International: 75915*
REF

16 Welch Allyn
Limited warranty
Welch Allyn warrants that the KleenSpec vaginal speculum cordless illumination system
products meet the labeled specifications of the Products and will be free from defects in
materials and workmanship that occur within one year after the date of purchase.
The date of purchase is: 1) the date specified in our records, if you purchased the Product
directly from us, 2) the date specified in the warranty registration card that we ask you to
send to us, or 3) if you don't return the warranty registration card, 30 days after the date
on which the Product was sold to the dealer from whom you bought the Product, as
documented in our records.
This warranty does not cover damage caused by: 1) handling during shipping, 2) use or
maintenance contrary to labeled instructions, 3) alteration or repair by anyone not
authorized by Welch Allyn, and 4) accidents.
If a Product or accessory covered by this warranty is determined to be defective because
of defective materials, components, or workmanship, and the warranty claim is made
within the warranty period described above, Welch Allyn will, at its discretion, repair or
replace the defective Product or accessory free of charge. If your Product requires repairs
covered by this warranty, upon your request Welch Allyn will loan to you, at no cost, a
substitute Product for use until your repaired Product is returned.
You must obtain a return authorization from Welch Allyn to return your Product before
you send it to Welch Allyn’s designated service center for repair. Contact Welch Allyn
Technical Support.
THIS WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILTY
AND FITNESS FOR A PARTICULAR PURPOSE. WELCH ALLYN'S OBLIGATION UNDER THIS
WARRANTY IS LIMITED TO REPAIR OR REPLACEMENT OF PRODUCTS CONTAINING A
DEFECT. WELCH ALLYN IS NOT RESPONSIBLE FOR ANY INDIRECTOR CONSEQUENTIAL
DAMAGES RESULTING FROM A PRODUCT DEFECT COVERED BY THE WARRANTY.