Welch Allyn KleenSpec User Manual
KleenSpec
®
790 Series
Cordless Illumination System
for the 590 Series Vaginal Speculum
REF
Directions for Use
79910
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: 718913 , Ver: A
Welch Allyn
4341 State Street Road, PO Box 220
Skaneateles Falls, NY 13153-0220
www.welchallyn.com
Printed in USA
Contents
Introduction ............................1
Charging the illuminator .................10
Using the illuminator for a pelvic exam.....11
Using the illuminator as light source .......11
Maintenance ...........................12
iii
Intended use .................................1
Contraindications ..............................1
User profile ..................................2
Symbols .....................................2
Using the system safely ........................4
Utilisation sécuritaire du système .................7
Cleaning and disinfecting .......................12
Inspecting the system .........................13
Recycling the system components ...............13
Troubleshooting ........................14
Contacts ..............................14
Appendix..............................15
Specifications................................15
Part numbers ................................17
Limited warranty .............................18
Service policy ................................19
EMC guidance and manufacturer’s declarations .....20
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.
Cordless
illuminator
Charging station
(base and power cord)
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.
Auxiliary power cord
(optional)
2 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.
Table 1. Documentation symbols
WARNING
Caution In this manual, this symbol and “Caution”
In this manual, this symbol and “WARNING”
indicate conditions or practices that could lead to
illness, injury, or death.
indicate conditions or practices that could
damage the equipment or other property.
On the product, this symbol means consult
operating instructions.
Table 2. Shipping, storing, and environment symbols
This end up Keep dry
95%
15%
-20C
Fragile Relative humidity limit
+49C
Temperature limits
Directions for use Cordless illumination system 3
Table 3. Certification symbols
Meets essential requirements of European Medical Device Directive
93/42/EEC.
EC REP
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
N344
Table 4. Operation symbols
Caution, hot surface
The speculum is a Type BF applied part
Alternating current
Direct current
Double insulation
IPXØ
Not protected from the ingress of liquid.
Recycle the product separately from other disposables. See “Recycling
the system components” on page 13.
Power plug
4 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.
• 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.
Directions for use Cordless illumination system 5
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.
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.
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 12.
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.
6 Welch Allyn
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 17.
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