Welch Allyn KleenSpec 78900 User manual

Welch Allyn®KleenSpec
78900 and 78950
Corded Illumination System
Quick start guide

© 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
This manual applies to 901070 VAGINAL
SPECULUM LIGHTING SYSTEM
Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 USA
www.welchallyn.com

1
Quick start guide
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. 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.
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
Power supply
Illuminator
On/Off switch

2
Inserting the Illuminator
Model 580
series
Model 590 series
Sheath

3
Classification
Class II, Type BF Applied Part Ordinary Equipment
Clean and disinfect as directed in Cleaning Section Non-continuous Operation
Symbol Descriptions
Warning Consult Directions for Use
Caution Lamp On
Caution, high temperatures Lamp Off
Caution, high intensity light Type BF Applied Part
Double Insulation Direct Current
IPX7
Illuminator is protected
against the effects of
temporary immersion in
water (and the solutions
described in this manual)
IPX0 Power supply - Not protected
from the ingress of water.
welchallyn.com
7d

4
Warnings and Cautions
WARNING: To avoid eye injury, do not look into the beam.
WARNING: Lamp is harmful to skin if touched. Allow lamp to cool for 5
minutes before replacing. Lamp generates heat and should remain off until
just prior to and immediately after use. Do not place illuminator onto a
flammable surface if lamp is illuminated.
WARNING: Disconnect power supply from 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. 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 or 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 lamp is installed and fully seated in illuminator throughout
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.

5
Cleaning and Disinfecting
Cleaning
Wipe
KleenSpec Corded Illumination System
Refer to Cleaning Table to identify the appropriate cleaning product.
1. Disconnect the power supply from the wall outlet.
2. Follow the disinfecting wipe manufacturer’s instruction and wipe cord or
illuminator completely to remove any residue.
3. This process is a rough clean only. Refer to disinfection for further
processing.
Soak
Refer to Cleaning Table to identify the appropriate cleaning product.
KleenSpec Corded Illuminator
1. Disconnect the power supply from the wall outlet.
2. Follow the cleaning solution manufacturer’s instructions and soak the
illuminator as instructed. 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.
3. 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.
KleenSpec Corded
Illuminator Power supply
Cleaning
CaviWipe
(Wipe) Yes Yes
Enzol (Soak) Yes No*
Metrizyme
(Soak) Yes No*
Disinfecting Caviwipe Intermediate Level Intermediate
Level
* Do not immerse the power supply plug. Follow instructions per this
manual.
CAUTION: Lamp must remain installed during all cleaning and
disinfecting processes.
CAUTION: Lamp must remain installed during all cleaning and
disinfecting processes.

6
4. Rough dry the illuminator.
5. The illuminator is now ready for disinfection.
Disinfecting
Refer to the Cleaning Table to identify the appropriate disinfection method/prod-
uct for the illuminator and power supply.
Illuminator
1. Clean or disinfect as described in the table above.
2. Follow the disinfecting wipe manufacturer’s disinfection instructions.
3. Thoroughly rinse illuminator with 22° C to 43° C tap water to remove
disinfectant.
4. Allow to dry.
Power supply
DO NOT IMMERSE THE POWER SUPPLY.
1. Clean or disinfect as described in the table above.
2. Follow the disinfecting wipe manufacturer’s disinfection instructions on the
cord only.
3. Thoroughly rinse the cord only with 22° C to 43° C tap water to remove
disinfectant. Do not immerse the power supply.
4. Allow to dry.
Disposal
There are no harmful materials associated with the Illumination System.
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