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

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

Directions for use Cordless illumination system 9
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.

10 Directions for use Welch Allyn
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 14.
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.

Directions for use Cordless illumination system 11
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
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 [phone]
Latin America + 1 305 669 9003 Netherlands + 31 202 061 360
Singapore + 656 419 8100 South Africa + 2711 777 7555
United Kingdom + 44 207 365 6780 Sweden + 46 85 853 6551

12 Directions for use Welch Allyn
Appendix
Specifications
Item Specification
Auxiliary power cord transformer
Classification
Input
Output
Category
U.S. & Canada
Class II and internally pow-
ered, type BF applied part
120V~60Hz
5.5 VDC, 300 mA
Not AP/APG equipment
International
Class I and internally pow-
ered, type BF applied part
100 - 240 VAC 200-100 mA
5.5 VDC, 300 mA
Not AP/APG equipment
Charging station transformer
Classification
Input
Output
Category
U.S. & Canada
Class I and internally
powered
120V~60Hz
9.8 VDC, 150 mA
Not AP/APG equipment
International
Class I, Class II and internally
powered
230 V (240 V in Australia) ~
50 Hz
7.5 – 9.2 VDC , 200 mA
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
420 mAh
3.7 V
Li-ion (single lithium ion)

Directions for use Cordless illumination system 13
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
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

14 Directions for use Welch Allyn
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

Directions for use Cordless illumination system 15
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 the date specified in our records, if you purchased the Product
directly from us or 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.

16 Directions for use Welch Allyn
Service policy
All repairs on products under warranty must be performed or approved by Welch Allyn.
Unauthorized repairs will void the warranty. In addition, whether or not covered under
warranty, any product repair shall exclusively be performed by Welch Allyn certified
service personnel.
If the product fails to function properly — or if you need assistance, service, or spare
parts — contact Welch Allyn.
Before contacting Welch Allyn, try to duplicate the problem, and check all accessories to
ensure that they are not causing the problem. When calling, please be prepared to
provide:
• Product name and model number and complete description of the problem.
• Serial number of your product (if applicable).
• Complete name, address and phone number of your facility.
• For out-of-warranty repairs or spare parts orders, a purchase order (or credit card)
number.
• For parts orders, the required spare or replacement part numbers.
If your product requires warranty, extended warranty, or non-warranty repair service,
please call Welch Allyn. A representative will assist you troubleshooting the problem and
will make every effort to solve it over the phone, avoiding potential unnecessary returns.
In case a return cannot be avoided, the representative will record all necessary
information and will provide a Return Material Authorization (RMA) number, as well as
the appropriate return address. An RMA number must be obtained prior to any return.
If you have to return goods for service, follow these recommended packing instructions:
• Remove all hoses, cables, sensors, power cords, and ancillary products (as
appropriate) before packing, unless you suspect they are associated with the
problem.
• Wherever possible use the original shipping carton and packing materials.
• Include a packing list and the Welch Allyn Return Material Authorization (RMA)
number.
It is recommended that all returned goods be insured. Claims for loss or damage to the
product must be initiated by the sender.

Directions for use Cordless illumination system 17
EMC guidance and manufacturer’s declarations
Table 1. Emissions for all EQUIPMENT and SYSTEMS
The 790 series cordless illumination system is intended for use in the electromagnetic
environment specified below. The customer or user of the 790 series cordless illumination system
should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11 Group 1 The 790 series cordless illumination system uses RF energy only for its internal function. Therefore, its RF emissions
are very low and are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11 Class B The 790 series cordless illumination system is suitable for use in all establishments including domestic and those
directly connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

18 Directions for use Welch Allyn
Table 2. Immunity for all EQUIPMENT and SYSTEMS
The 790 series cordless illumination system is intended for use in the electromagnetic environment
specified below. The customer or user of the 790 series cordless illumination system should assure
that it is used in such an environment.
Immunity test IEC 60601
test level
Compliance
level
Electromagnetic environment -
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
±8kVair ± 6 kV contact ±8kVair Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative
humidity should be at least 30%.
Electrical fast
transient (EFT)/
burst
IEC 61000-4-4
±2 kV mains
±1 kV I/O ±2 kV mains Not applicable Mains power quality should be that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5 ±1 kV differential ±2 kV common ±1 kV differential ±2 kV common Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines.
IEC 61000-4-11
>95% dip in
0.5 cycle
60% dip in
5 cycles
30% dip for
25 cycles
>95% dip in
5 seconds
>95% dip in
0.5 cycle
60% dip in
5 cycles
30% dip for
25 cycles
>95% dip in
5 seconds
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the 790
series cordless illumination system
requires continued operation during
power mains interruptions, it is
recommended that the 790 series
cordless illumination system be
powered from an uninterruptible
power supply or battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical
commercial or hospital environment.