CryoConcepts CryOmega Multi Use Disposable Cryosurgical Device Instructions
- June 11, 2024
- CryoConcepts
Table of Contents
CryoConcepts CryOmega Multi Use Disposable Cryosurgical Device Instructions
INSTRUCTIONS FOR USE
INTENDED USE–FOR MEDICAL PROFESSIONAL USE ONLY
The CryOmega® is a multi-use disposable device intended for the surgical
destruction of target tissue by applying cryogenic gases at extreme low
temperatures. The list below shows examples of the types of lesions that can
be treated.
- Verruca Vulgaris
- Verruca Plantaris
- Molluscum Contagiosum
- Skin Tags
- Lentigo
- Actinic Keratosis
- Verruca Plana
- Seborrheic Keratosis
- Genital Lesions
BACKGROUND
Cryosurgery is routinely used by medical professionals to treat a variety of
lesions. Extreme cold works to destroy tissue through lysis of cells. This may
occur through the formation of ice or rapid changes in osmotic pressure. Both
can work to increase the overall effectiveness of cryosurgical treatments
(1,2). CryOmega® is a self-contained disposable cryosurgical device that
sprays a stream of liquid nitrous oxide.
PRINCIPLE OF ACTION
Evaporation of the liquified cryogenic gas draws heat from the surroundings.
The CryOmega® device serves as a reservoir for the cryogen-N2O delivering the
liquid gas directly onto the lesion to be treated at -89°C. Following cryo
treatment, necrosis of the site can occur. Recovery takes about 10 to 14 days,
with new tissue growing inwards from the surrounding epidermis and the more
deeply situated adnexa (1,3).
THE CRYOMEGA® UNIT CONSISTS OF:
- Disposable cryogen delivery device complete with N2O gas cartridge. N2O does not cause damage to the ozone layer and is not flammable.
- Instructions for use. This manual contains full details concerning the principle and operation of the CryOmega® and its use.
CryOmega® should be supplied only to and used by healthcare professionals. Imprudent use can lead to unwanted damage to the skin and underlying tissues.
STORAGE, TRANSPORT, AND CLEANING
The gas supply is pressurized. Protect the unit from direct sunlight and do
not expose to or store at temperatures in excess of 50°C/122°F. The CryOmega®
can be operated at ambient room temperature. Use CryOmega® in a well
ventilated room.
Store CryOmega® away from heat or potential sources of heat. The CryOmega® may be cleaned with 70% alcohol or 3% hydrogen peroxide as needed.
Relative contraindications
- Uncertainty concerning the diagnosis of the disorder (possibility of skin cancers).
- Freezing (to excessive depth) in the region of peripheral arteries in fingers and toes theoretically can produce necrosis distal to the frozen lesions.
GENERAL PRECAUTIONS
Cryosurgery can produce a painful, burning sensation on the skin. Acceptance
of the treatment can be enhanced substantially by informing patients about the
potential for pain to occur, the anticipated number of treatments, any
preparatory treatment that might be required, possible undesirable effects and
follow-up treatment.
INSTRUCTIONS FOR ACTIVATION AND USE
-
While holding the CryOmega® device with one hand, firmly grab the knob at the end of the unit with the other hand.
-
Firmly turn the knob clockwise one full rotation, making sure that the white dot on the knob aligns with the arrow on the device. The unit is now ready for use.
-
Make sure that the white dot on the knob aligns with the arrow on the device. Important: Do not turn the knob back—the unit is now under pressure!
-
Position the patient such that the surface to be treated is exposed and facing upwards.
-
Hold the CryOmega® device vertically, tip down, and position the spray nozzle directly over the lesion at a 1cm distance. Then press the actuator and spray cryogen directly onto the lesion moving the spray in a small circle to cover the area.
-
Release the actuator to stop the cryogen spray.
SUGGESTED PATIENT INFORMATION
Cryosurgery works by destructively freezing target tissue. The spray of
cryogen evaporates on the skin at a temperature of -89°C. The uppermost layer
of skin, together with the diseased tissue, will disappear. It will be
replaced by a new healthy layer of skin in 10 to 14 days. Freezing commences
once spray is applied to the skin. The affected skin will turn white. From
this point on, the patient may experience a stinging or burning sensation.
This sensation will fade rapidly after the thawing phase. Temporary, visible
changes in the intensity of pigmentation may occur following treatment.
Cryosurgery can produce blisters which you should not lance. Instead, protect
it with a covering or bandage. Keep the treated area clean and do not pick or
scratch it. Swimming and bathing are permitted. Some lesions or warts may
require multiple treatments.
ADDITIONAL INSTRUCTIONS AND WARNINGS
- Freezing starts immediately as shown by the white discoloration of the skin. From this point on, the patient may experience stinging, burning or, occasionally, painful sensations.
- Cryosurgical research suggests that a narrow strip of healthy tissue should be frozen along with the target tissue for maxi-mum effectiveness (3).
- Once the cryogen spray has stopped, the white discoloration of the skin will fade away after a few minutes followed by erythema.
- A blister, sometimes filled with blood, may develop after minutes to a few days following freezing. In areas with a thick layer of callus, such blisters will not necessarily be visible to the unaided eye. Do not lance the blister; instead, protect it by covering it with a tape or bandage.
- The CryOmega® is empty when the spray is no longer cold and visible. The unit should be discarded once this occurs and a new unit should be activated.
- Examples of types of lesions for treatment are listed. Treatment of other types of tissue should only be performed based on the professional’s experience.
FOLLOW-UP TREATMENT SUGGESTIONS
- Keep the treated area clean.
- Swimming or showering are permitted.
- Patients should not pick or scratch the treated area.
- Use a bandage to protect any blisters that may form.
- Do not lance any blisters that may form.
UNDESIRABLE EFFECTS AND WARNINGS
- A stinging or painful sensation may be experienced during and after freezing, which will fade rapidly after treatment.
- Changes in the intensity of pigmentation may occur. This will generally take the form of hypopigmentation; how-ever, post-inflammatory hyperpigmentation due to melanin or haemosiderin can also occur.
- Imprudent use may lead to excessively deep freezing, pro-ducing damage to the dermis and consequent scar formation and nerve damage.
The depth of freezing using the CryOmega® will be dependent on the time and distance of the spray from the treated surface. The medical literature has many reports of varying cryogen spray times. In addition to the distance of the spray from the lesion, the thickness, location and hydration of the target tissue can affect outcomes. Medical professionals should be familiar with cryosurgical techniques when using the CryOmega®.
WARRANTY
Each CryOmega® unit is warranted against technical defects for 1 year while
unactivated and kept in the original packaging. This warranty will exchange
defective units for new units. The warranty assumes normal use and compliance
with storage and handling instructions
REFERENCES
- Rubinsky, Boris, CryoSurgery, Annual Review Biomedical Engineering, 02:157-187, 2000.
- Gage, Andrew, What Temperature is Lethal for Cells? J Dermatol Surg Oncol, 5-6, 1979.
- Andrews, Mark, CryoSurgery for Common Skin Conditions, American Family Physician, 69:10, 2365-2372, 2004.
- Dawber, Rodney, Colver, Graham, et.al., Cutaneous Cryosurgery: Principles and Clinical Practice, Martin Dunitz Publisher, 2cd Edition, 1997.
- Strumia, Renata, La Crioterapia in Dermatologia, Published by Business Enterprise SRL, 2006.
- Dockery, Gary, Treating A Child With Multiple, Mildly Pruritic Papules, Podiatry Today, 20:4, 2007.
INSTRUCTIONS FOR USE
CAUTION/ATTENTION
MANUFACTURER
THIS SYMBOL INDENTIFIES THE IMPORTER
PROTECT FROM SUNLIGHT
DO NOT EXPOSE TO TEMPERATURES EXCEEDING 50°C
MEDICAL DEVICE
AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
AUTHORIZED SWISS REPRESENTATIVE
Manufacturer:
CryoConcepts LP
1100 Conroy Street
Easton, PA 18040, USA
www.cryoconcepts.com
MedEnvoy Global BV
Prinses Margrietplantsoen 33
Suite 123
2595 AM The Hague
The Netherlands
References
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