Welch Allyn EpiScope Skin Surface Microscope User Manual

Welch Allyn EpiScope™ Skin Surface Microscope Directions for Use

47300

Intended use

Allows visualization and measurement of skin surface lesions.

Symbols

WARNING identifies information within the manual

to avoid injury.

CAUTION identifies information within the manual to avoid equipment failure.

Temperature Range

95%

Humidity Range

15%

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

Do not dispose of this product as unsorted municipal waste. Prepare this product 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 Customer Service +44 207 365 6780.

Warnings and cautions

WARNING This cleaning and disinfection procedure

and the equipment and materials described must be followed and conducted by persons trained and familiar with medical device cleaning and disinfection.

WARNING Consult your facility's procedures and the reprocessing agents manufacturer's instructions for the agents reuse, recommended Personal Protective Equipment, and other safety precautions.

WARNING Lamps may be hot. Allow to cool before removal. Handle and dispose of the lamp with care to avoid shattering. Use protective eyeglasses when handling.

WARNING The EpiScope is intended to be used ONLY with intact skin.

CAUTION Failure to follow these instructions may cause damage to this device.

CAUTION Do not immerse or allow excessive moisture to contact the EpiScope. Doing so may cause damage to the device.

CAUTION Only use the cleaner disinfectant types identified within these instructions. Do not use other cleaners or disinfectants.

CAUTION Always follow the cleaner or disinfectant manufacturers’ instructions for proper use.

CAUTION Repeated reprocessing may degrade elements of the device. Follow inspection procedures to assure damage has not occurred.

CAUTION Do not use abrasive material to clean lens. Doing so can scratch and permanently damage optics.

CAUTION The EpiScope is not for diagnostic purpose/use.

Components

Rubber Eye Guard

Focal Ring

Battery Handle

Instructions

1. Install EpiScope onto Welch Allyn 3.5v handle.

3. Center EpiScope over lesion to examine surface and adjust focal ring

Note: To reduce glare, moisten skin with oil.

Note: Roll back rubber eye guard if you wear glasses.

2. Power ON

Contact Plate

Note: To examine raised moles or lesions, remove contact plate.

Rheostat

Care and maintenance

Cleaning and disinfection

The following instructions apply to the Welch Allyn EpiScope.

Limitations on cleaning and disinfection

This device may be cleaned and disinfected multiple times in accordance with these instructions. Cleaning and disinfection process must include inspection to assure damage has not occurred.

Instructions for cleaning the EpiScope

Clean EpiScope with a mild glass cleaning type solution labeled compatible for use on plastic. Use of prepackaged glass cleaner wipes is preferred, however, cleaning solutions can also be lightly applied to a lint-free cloth and then used on the EpiScope.

Apply pre-moistened wipe/cloth to surfaces of the EpiScope and wipe to clean visible debris.

Instructions for cleaning the EpiScope’s lens or contact plate glass

Clean debris from the lens or contact plate with a cottontipped applicator moistened with 70% ethyl alcohol.

Instructions for disinfecting the EpiScope’s contact plate glass

After cleaning, the EpiScope’s contact plate can be disinfected with the following hospital-type low or intermediate level disinfectant solutions:

• Quaternary ammonium based, with alcohol (<50%) low or intermediate level disinfectant.

• Inorganic chlorine based, low or intermediate level disinfectant.

Note: Combination cleaner/disinfectants that carry a low or intermediate level disinfectant claim based upon the disinfectant types noted above are also suitable for use on the contact plate.

1. Remove the contact plate as shown:

2. Apply disinfectant to the contact plate per disinfectant

agent manufacturer's instructions.

3. After disinfection, the optical element may be recleaned if

necessary.

4. Re-install contact plate on to the EpiScope.

Maintenance, inspection, and testing

1. Inspect the EpiScope for signs of damage.

2. Appropriately discard any component that shows

evidence of damage or deterioration.

3. Contact Welch Allyn for component replacement.

4. Verify the proper operation of the EpiScope per this

manual’s directions for use.

Storage

Store the EpiScope in a dry, clean area. A carrying case accessory is available, which holds the 3.5v rechargeable handle and extra contact plate.

Lamp replacement

1. Remove EpiScope 2. Remove lamp

3. Remove new 03000 lamp from packaging. Be careful not to touch the glass surface. If lamp surface is smudged, wipe clean with a soft cloth

4. Insert 03000 Lamp until contact pin is below base flange.

5. Install EpiScope

Power sources

The EpiScope Skin Surface Microscope is compatible with all 3.5 v. Welch Allyn power sources.

Accessories

47310 Reticle Contact Plate

47320 Plano Contact Plate

05232 Carrying Case

Warranty

Welch Allyn warrants the product to be free of defects in material and workmanship and to perform in accordance with the manufacturer’s specifications for the period of one year from the date of purchase from Welch Allyn or its authorized distributors or agents. Welch Allyn will repair or replace, free of charge, any parts of its own manufacture, proven to be defective through causes other than misuse, neglect, damage in shipment, or normal wear. The EpiScope contact plates are guaranteed for one year from date of purchase.

Technical specifications

Magnification: 10x

Focal Range (correction):

Focal Length: 25mm

Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153 USA Tel. +1 800 535 6663 or +1 315 685 4560 Fax. +1 315 685 3361 www.welchallyn.com

For Welch Allyn Service Center telephone numbers, visit: www.welchallyn.com/about/company/ locations.htm

Regulatory Affairs Representative Welch Allyn Limited Navan Business Park, Dublin Road, Navan, County Meath, Republic of Ireland

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© 2013 Welch Allyn, Inc. All rights 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. 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. Welch Allyn is a trademark of Welch Allyn, Inc.