CryoConcepts FLEX Cryosurgery Histofreezer Instructions
- September 23, 2024
- CryoConcepts
Table of Contents
FLEX Cryosurgery Histofreezer
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Specifications:
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Product: Histofreezer FLEX or Histofreezer
STAT -
Doc. No.: PB24-001
-
Revision: 1
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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:
-
After each use, discard the buds or cone tips that have touched
the patient being treated. -
Wipe the canister of gas and handle with a water-based biocide
or 70% alcohol after each use. -
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