Cryocones Instructions for Use Issue 3 Feb 2021

Brymill Cryogenic Systems 105 Windermere Ave., Ellington. CT 06029. U.S.A. Tel: 860-875-2460 Fax: 860-872-2371

INSTRUCTIONS FOR USE CRYOCONES

1. BASIC OPERATING PRINCIPLES The Cryocones are supplied as a set of 6 differently sized Neoprene Cones used for the protection of the surrounding tissue at the margins of a lesion and to direct the spray of Liquid Nitrogen. The flexibility of the Cryocones enables you to treat odd shaped lesions. 2. OPERATING INSTRUCTIONS

1. Select the appropriate size cone that provides the required margin around the lesion to be treated(1). 2. If necessary, the Cryocone can be flexed to achieve the approximate shape of the lesion. 3. Place the cone over the lesion ensuring an even margin and firm contact with the skin 4. Carry out the required “timed spot freeze technique” (1). 3. DECONTAMINATION Thorough cleaning and then disinfection of the Cryocone using an Alcohol wipe prior to use is recommended between patient episodes. 3.1 Recommended Disinfectant: Alcohol wipes. Safety Note – Always refer to the Health & Safety Data Sheet for appropriate protective clothing before using any Disinfectants. 3.2 Procedure Wearing appropriate protective clothing ensure that all surfaces are thoroughly wiped using an Alcohol wipe • •

Ensure all surfaces are carefully hand-dried using a dry cloth. Safely dispose of alcohol wipes.

CAUTIONS Protective Cryo Gloves should be worn when using Cryocones Refer to the Material Safety Data Sheet for the safe handling of Liquid Nitrogen. (Provided by Gas Supply Co.) (1)

American Family Physicians – Volume 69, Number 10/May 15, 2004 – Cryosurgery for Common Skin Conditions

-----------------------------------------------------------------------------------------------------------------------------EU Authorized Representative –

Rosa Maria Sallent Moya, Calle Jaume Balmes, 59, 08830 Sant Boi de LLobregat SPAIN Phone: +34 616602892 Email:[email protected]

Page 1 of 1 Form – IN7 1639

Issue 3 February 2021