CryoConcepts FLEX Cryosurgery Histofreezer Instructions

September 23, 2024
CryoConcepts

FLEX Cryosurgery Histofreezer

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Specifications:

  • Product: Histofreezer FLEX or Histofreezer
    STAT

  • Doc. No.: PB24-001

  • Revision: 1

  • Publication Date: 24 Jun 2024

Product Information:

The Histofreezer FLEX is designed to treat a variety of topical
lesions. It can be used with either buds or its uniquely designed
two-part cone system. The canister of gas and handle cannot be
heated for cleaning and should be wiped with water-based biocide or
70% alcohol as per the Instructions for Use.

The applicators or cone tips must be discarded after each
patient. Each kit includes four cone adapters which should also be
cleaned using a water-based biocide cleaner or 70% alcohol.

Usage Instructions:

  1. After each use, discard the buds or cone tips that have touched
    the patient being treated.

  2. Wipe the canister of gas and handle with a water-based biocide
    or 70% alcohol after each use.

  3. Clean the cone adapters with a water-based biocide cleaner or
    70% alcohol.

FAQ:

Q: Can the applicators or cone tips be reused?

A: No, the applicators or cone tips must be discarded after each
patient to prevent cross-contamination.

Q: What should I do if I have specific questions about cleaning

the Histofreezer FLEX?

A: For specific questions, please contact CryoConcepts at
CustomerCareMed@cryoconcepts.com or call 1-855-355-CRYO.

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DATE: 24 June 2024
PRODUCT: Histofreezer FLEX or Histofreezer STAT SUBJECT: Recommended Cleaning of Adapter and Why
The Histofreezer FLEX may be used with either buds or its uniquely designed two-part cone system. As per the Instructions for Use (IFU), both buds and cone tips are discarded after use since they have touched the patient being treated.
The question has arisen about the cone adapter and how best to clean it after use? This Bulletin was written to help direct clinicians on how to approach this question and the supporting information. The Leidenfrost Effect: When using cones to treat a topical lesion, the Histofreezer FLEX dispenses a small amount of liquid gas into the cone tip. The liquid will appear to bubble in the cone tip and adapter and eventually evaporate freezing the targeted area. It is important to understand how this process is working. In practice, the gas does not touch the surface of the skin. The difference in temperature between the warm skin and the cold gas creates a vapor layer at the surface of the skin. Heat from the skin is transferred through the vapor layer to the gas which then slowly evaporates. This is known as the Leidenfrost Effect and is the reason the gas only acts to take heat from the skin but never actually touches it. See Image below:
DeWitt; Bergman; Lavine (2006). Fundamentals of Heat and Mass Transfer (6th ed.). pp. 325­330.

Doc. No.: PB24-001

Revision: 1

Publication Date: 24 Jun 2024

Cleaning of Histofreezer FLEX:
The Histofreezer FLEX is designed to treat a variety of topical lesions. The canister of gas and handle cannot be heated to clean and therefore may be wiped with any water-based biocide or 70% alcohol (see Instructions for Use).
As mentioned above the applicators or cone tips must be discarded after each patient. Four cone adapters are supplied in each kit. These should also be treated with a water-based biocide cleaner or 70% alcohol.
Summary:
Each clinical site will have protocols for cleaning and use of equipment and kits. The Histofreezer FLEX instructions provides guidance that is compatible with the product component materials and intended use. Please contact CryoConcepts at CustomerCareMed@cryoconcepts.com or call 1-855-355-CRYO if there are specific questions about this topic.

Doc. No.: PB24-001

Revision: 1

Publication Date: 24 Jun 2024

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