WelchAllyn KleenSpec 78950 Corded Illumination System User Guide

: June 16, 2024
: WelchAllyn

Table of Contents

WelchAllyn KleenSpec 78950 Corded Illumination System
Product Information
Product Usage Instructions
KleenSpec Corded Illumination System
Inserting the Illuminator
Classification
Symbol Descriptions
Warnings and Cautions
Cleaning and Disinfecting
FAQ
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

WelchAllyn KleenSpec 78950 Corded Illumination System

Product Information

Specifications

Product Name: Welch Allyn KleenSpec Corded Illumination System
Model: 901070 VAGINAL SPECULUM LIGHTING SYSTEM
Compatible Specula: 58000S, 58001S, 58004S, 590XS, 59000, 59001, 59004, 59005, and 59006
Power Supply: Hospital-grade wall outlet
Classification: Class II, Type BF Applied Part
Operation: Non-continuous
Illuminator Protection: IPX7 (temporary immersion in water)
Power Supply Protection: IPX0 (not protected from water)

Product Usage Instructions

Inserting the Illuminator
To insert the illuminator into the Welch Allyn KleenSpec Vaginal Specula, follow these steps:

Ensure the illuminator is turned off.
Slide the illuminator into the appropriate KleenSpec Vaginal Specula.
Verify all connections are securely made.

Powering On/Off
To power on/off the KleenSpec Corded Illumination System, use the on/off switch located on the power supply:

Connect the power supply to a hospital-grade wall outlet.
Turn on the illuminator by flipping the on/off switch to the “on” position.
Turn off the illuminator by flipping the on/off switch to the “off” position.
Disconnect the power supply from the wall outlet for maintenance.

Usage Precautions
Follow these precautions when using the Welch Allyn KleenSpec Corded Illumination System:

This product is designed for use with the Welch Allyn KleenSpec Vaginal Specula only. Do not use the illuminator for any other purpose.
The lamp inside the illuminator generates heat. Allow the lamp to cool for 5 minutes before replacing it.
Do not touch the lamp with bare skin as it can be harmful. Handle the lamp with caution.
Do not place the illuminator on a flammable surface if the lamp is illuminated.
Do not look directly into the beam to avoid eye injury. The KleenSpec Corded Illumination System is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide, as it may cause an explosion.

2018 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. No other use, reproduction, or distribution of this publication, or any part of it, is permitted without written permission from Welch Allyn. Welch Allyn assumes no responsibility for any injury to anyone, 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 statement of intended use published in this manual. For patent information, visit www.welchallyn.com/patents. For information about any Welch Allyn product, contact your local Welch Allyn representative: http://www.welchallyn.com/en/other/contact-us.html. MATL 728645 (Printed Copy), 80023837 Ver A Revised: 2018-08 Welch Allyn, Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA www.welchallyn.com This manual applies to SPECULUM LIGHTING SYSTEM

KleenSpec Corded Illumination System

The KleenSpec Corded Illumination System is designed to work with the following Welch Allyn specula: 58000S, 58001S, 58004S, 590XS, 59000, 59001, 59004, 59005, and 59006 for gynecological and obstetric procedures. The power supply provides power from the hospital-grade wall outlet to the illuminator assembly which houses the lamp. This provides illumination to the specula. This device is intended for use only with Welch Allyn-appropriate accessories. This product is for use with the Welch Allyn KleenSpec Vaginal Specula only. Do not use the illuminator for any other use. The lamp is hot and can cause a burn if used outside of the vaginal specula. The illuminator slides into the appropriate Welch Allyn KleenSpec Vaginal Specula listed above. Verify all connections are made prior to applying power with the on/off switch.

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Note
For a complete copy of the directions for use, visit www.welchallyn.com. For a printed copy of the directions for use, contact Welch Allyn Technical Support: (www.welchallyn.com/support), or visit www.welchallyn.com/about/company/locations.htm

Inserting the Illuminator

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Classification

Class II, Type BF Applied Part Ordinary Equipment Clean and disinfect as directed in Cleaning Section Non-continuous Operation

Symbol Descriptions

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Warnings and Cautions

WARNING : To avoid eye injury, do not look into the beam.
WARNING : Lamp is harmful to the skin if touched. Allow the lamp to cool for 5 minutes before replacing. The lamp generates heat and should remain off until just prior to and immediately after use. Do not place the illuminator onto a flammable surface if the lamp is illuminated.
WARNING : Disconnect the power supply from the outlet prior to any maintenance.
WARNING : This product is for use with the Welch Allyn KleenSpec Vaginal Specula only. Do not use the illuminator for any other use. The lamp is hot and can cause a burn if used outside of the vaginal specula.
WARNING : KleenSpec Corded Illumination System is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide. An explosion may result.
WARNING : The lamp is hot and can cause burns if used outside of the vaginal specula.
CAUTION : Properly secure all cords and cables to minimize trip hazards.
CAUTION : Use only the cleaning methods and disinfection solutions/methods described in this manual. Clean the device prior to disinfection.
CAUTION : The Illuminator is a biohazard after use. Follow good hospital practices and the instructions for cleaning and disinfection of the illuminator
within this manual prior to the next usage.
CAUTION : Ensure the lamp is installed and fully seated in the illuminator throughout the cleaning and disinfection process. The illuminator assembly is immersible (IPX7) provided the lamp is properly installed.
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 : The illuminator cable is capable of temporary immersion to a depth of 0.15 to 1 meter, at ambient pressure, at room and fluid temperatures of 22° C to 43° C. The power supply is not. Do not immerse the power supply. U.S. Federal Law restricts this device to sale by or on the order of a physician. To remove all power from the Vaginal Illumination System, unplug the external power supply from the wall outlet. There are no user-serviceable parts inside the device except the lamp. Contact Welch Allyn Technical Support: www.welchallyn.com/support.

Cleaning and Disinfecting

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Do not immerse the power supply plug. Follow the instructions per this manual.

Cleaning
Wipe
KleenSpec Corded Illumination System Refer to the Cleaning Table to identify the appropriate cleaning product.

Disconnect the power supply from the wall outlet.
CAUTION : Lamp must remain installed during all cleaning and disinfecting processes.
Follow the disinfecting wipe manufacturer’s instructions and wipe the cord or
illuminator completely to remove any residue.
This process is a rough clean only. Refer to disinfection for further processing.

Soak
Refer to the Cleaning Table to identify the appropriate cleaning product.

KleenSpec Corded Illuminator

Disconnect the power supply from the wall outlet.
CAUTION : Lamp must remain installed during all cleaning and disinfecting processes.
Follow the cleaning solution manufacturer’s instructions and soak the illuminator as instructed. The solution temperature is 22° C to 43° C. Make sure to keep the power supply out of the soak solution. Do not immerse the power supply.
Scrub any area of visible debris with a soft brush and thoroughly rinse the illuminator with 22° C to 43° C tap water to remove the cleaning solution. Do not rinse the power supply; wipe only.
Rough-dry the illuminator.
The illuminator is now ready for disinfection

Disinfecting
Refer to the Cleaning Table to identify the appropriate disinfection method/product for the illuminator and power supply.

Illuminator

Clean or disinfect as described in the table above.
Follow the disinfecting wipe manufacturer’s disinfection instructions.
Thoroughly rinse the illuminator with 22° C to 43° C tap water to remove the disinfectant.
Allow to dry.

Power supply
DO NOT IMMERSE THE POWER SUPPLY.

Clean or disinfect as described in the table above.
Follow the disinfecting wipe manufacturer’s disinfection instructions on the cord only.
Thoroughly rinse the cord only with 22° C to 43° C tap water to remove disinfectant. Do not immerse the power supply.
Allow to dry.

Disposal
There are no harmful materials associated with the Illumination System. The device is considered a biohazard after use. Follow good hospital practices and local ordinances in the disposal of the illuminator. There are no risks associated with the disposal of this device after its useful life if it is cleaned and/or disinfected per the instructions in this manual.

Approvals
CERTIFIED TO: CAN/CSA STD C22.2 NO. 601.1 CONFORMS TO: IEC 60601-1, IEC60601-1-2

4341 State Street Road Skaneateles Falls, NY 13153 Tel: 800-535-6663 or 315-685-4560 Fax: 315-685-3361 www.welchallyn.com