Welch Allyn 79900, 79915, 79920, 79910, 79925 Directions For Use Manual

KleenSpec® 790 Series

Cordless Illumination System

for the 590 Series Vaginal Speculum

Directions for Use

REF

79910

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.

Welc h Allyn and KleenSpec are registered trademarks of Welc h 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

Contents

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Charging the illuminator . . . . . . . . . . . . . . . . . . 8

Using the illuminator for a pelvic exam. . . . . . 9

Using the illuminator as light source . . . . . . . . 9

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 10

iii

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

User profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Using the system safely . . . . . . . . . . . . . . . . . . . . . . . . 4

Utilisation sécuritaire du système . . . . . . . . . . . . . . . . . 6

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.

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 ma y 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 “WARNING” indicate
conditions or practices that could lead to illness, injury,
or death.

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

+49°C

Temperature limits

-20°C

Directions for use Cordless illumination system 3

IPXØ

Table 3. Certification symbols

Meets essential requirements of European Medical Device Directive
93/42/EEC.

EC REP

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.

US

C

166292

EMC framework of Australia

N344

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

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 LED radiation. Class 2 LED product. To av oid e y e 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

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 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.