Product Manual

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Portable Cryosurgical System
Histofreezer
®
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1. Aerosol canister. Filled with a cryogenic gas mixture that is
flammable but does not damage the ozone layer.
2. Applicators. The package includes:
2mm Small applicators and/or 5mm Medium applicators.
3. Directions for use. The operating principle behind the
Histofreezer Portable Cryosurgical System unit and its use
for the removal of warts and other benign skin lesions is
contained herein.
Important
The Histofreezer Portable Cryosurgical System should only be
supplied to and used by medically trained healthcare
professionals. Improper use can lead to unwanted damage to
the skin and underlying tissues. It is prohibited to sell or give
the Histofreezer Portable Cryosurgical System kit to patients.
Use the aerosol canister only in combination with the special
Histofreezer Portable Cryosurgical System applicators.
Storage and transport
The canister is pressurized and its contents are flammable.
Protect it from direct sun light and do not expose it to
temperatures in excess of 50˚C. Even after use, do not pierce
or burn. Do not spray in the direction of a flame or any
incandescent material.
Operating Principles
The Histofreezer Portable Cryosurgical System achieves its
effect on epidermal lesions by freezing resulting in a separation
between the epidermis and the basal membrane. All cryogenic
methods are based on this principle. A small quantity of the
cryogen is sprayed into the Histofreezer Portable Cryosurgical
System applicator, which serves as a reservoir for the coolant.
The coolant evaporates immediately, and the applicator reaches
an effective temperature of approximately -55˚C. Following
treatment, the frozen epidermis peels away in about two to
three days and new epidermis grows in its place. Blistering of
treated area may occur. One to four treatments with intervals of
two weeks may be required. Please read all directions prior to
use of the Histofreezer Portable Cryosurgical System.
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Absolute contra-indications
Cryotherapy is contraindicated in patients with
cryoglobulinaemia.
Precautions
• Do not use if uncertain of diagnosis (possibility of
skin cancers).
• Depigmentation of dark skin may occur. In light-colored
skin, depigmentation is barely noticeable, but may color
differently after exposure to sun. Hyperpigmentation is rare;
however, caution should be exercised when using the
product on facial areas.
• Freezing to excessive depth in the vicinity of terminal
arteries (fingers and toes) could lead to necrosis. Necrosis
has not been observed with use of the Histofreezer Portable
Cryosurgical System. It is advisable to treat only one side of
fingers and toes at a time to avoid freezing arteries or veins.
• Warts that include an infected area should first be
treated medically to resolve the infection prior to
cryosurgical treatment.
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General
Cryotherapy can produce a painful, burning sensation on
the skin. Acceptance of the treatment can be enhanced
substantially by informing patients about the degree of pain
that can be expected, the anticipated number of treatments,
any preparatory treatment that might be required, possible
undesirable effects and the follow-up treatment. It is also
advisable to inform patients that the location and size of warts
may affect resolution rates.
Preparatory Treatment
Keratin tends to act as a thermal insulator. With highly elevated
warts (in excess of a few mm), it can be useful to remove the
uppermost layer of keratin by lightly debriding with a curette,
file or pumice stone. Preparatory treatment can enhance the
efficacy of the Histofreezer Portable Cryosurgical System
product and reduce the number of applications required.
Treatment Procedure
1. Position the patient to expose
the skin surface to be treated.
2. Insert the applicator into the
canister valve with a twisting
motion, and then remove the
protective cap from the upright
canister.
3. Hold the canister and
applicator away from skin and
press the dispensing valve
until the first droplet emerges
from the foam tip, then release
finger from valve.
The droplets will not harm
clothing or office furnishings.
4. Keep finger off the valve and
turn the canister, so the
applicator is in a vertical
position (90-degree angle).
Then wait 15 seconds for the
applicator to reach its
effective temperature.
5. Continue to hold canister in
the same position and with
light pressure, place the
applicator on the treatment
area for the recommended
time listed on the canister
label or Directions for Use.
Treating at any other angle
than a 90-degree angle will
reduce the effectiveness of
the treatment.
Important: Do not press valve while the Histofreezer
applicator is in contact with patient’s skin.
• A saturated 2mm applicator will stay cold for 90 seconds
and the 5mm applicator will stay cold for 120 seconds.
This is long enough to perform 1 to 2 applications on the
same patient.
• After first use, lift applicator from contact with skin and
hold it in a vertical position again (90-degree angle), then
wait for 15 seconds for it to return to the treatment
temperature. Now it is ready to apply to the next “like”
wart or section of lesion.
6. A small ring of healthy tissue around the lesion should also
be frozen during the process.
• Freezing begins within a few seconds and may appear as
white discoloration of the skin. The patient experiences a
tingling/itching feeling and sometimes a slight stinging
sensation of the region.
• The skin will lose its white color a few minutes after the
applicator has been removed. Erythema then appears
the same size as the frozen region. Tingling or itching
felt during freezing usually stops quickly after treatment.
• Blistering may occur (sometimes filled with blood) within
a few days. The blistering may not be macroscopically
visible on sites with a thick, horny layer.
Follow-up treatment
• Keep the treated area of skin clean.
• Swimming or showering are permitted.
• Do not pick or scratch the treated area.
• Do not lance any blisters that may form. If blisters open,
protect with adhesive bandage.
Undesirable effects
• A stinging or painful sensation during and after freezing,
which will rapidly fade away after the thawing phase.
• Changes in the intensity of pigmentation may occur. This
will generally take the form of hypopigmentation; however,
post-inflammatory hyperpigmentation due to melanin or
haemosiderin can also occur.
Remarks
• DO NOT REFREEZE AN APPLICATOR
• Dispensing additional cryogen causes more water vapor to
condense onto the applicator, thereby making it so damp as
to impair its function as a reservoir. Visible ice crystals then
form. If this should occur, replace the applicator with
a new one.
• If tissue does not appear to be freezing, saturate
applicator. Hold canister so tip is vertically downward and
wait 15 seconds. This will allow applicator to reach the
optimal freezing temperature.
• Improper use can lead to excessively deep freezing,
producing damage to the dermis and consequent scar
formation and nerve damage.
• To avoid cross contamination, do not treat two patients with
the same disposable applicator.
See reverse side for
Recommended Freezing Times
and Recommended Procedure for
Plantar Wart Treatment
The Histofreezer Portable Cryosurgical System is a registered
trademark of OraSure Technologies, Inc.
© 1992, 2011 OraSure Technologies, Inc.
U.S. Patents #5738682 and #6092527 and
various international patents.
Manufacturer:
OraSure Technologies, Inc.,
Bethlehem, PA 18015 USA
www.orasure.com
Visit our Product website at:
www.histofreezer.com
Portable Cryosurgical System
Histofreezer
®
Item# 3001-2201 rev. 10/11
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