Important notes
Application
Cryoalfa® is a mobile and effective device for the removal of warts, skin tags, fibromas, keratoses, hemangiomas, age spots and other common skin lesions. Cryosurgical treatment is painless, can be performed without preparation, and can be repeated indefinitely without side effects if needed. The Cryoalfa® devices have been continuously developed for a long time and convince with high effectiveness. The integration of the valve in the capsule prevents the escape of treatment gas. Cryoalfa® devices are particularly safe and absolutely maintenance-free.
Introduction and purpose
- Purpose: The devices of the Cryoalfa family are multi-use devices intended for the controlled elimination of pathologically altered tissue by application of extreme cold induced by liquid N2O (nitrous oxide, supplied in 16g or 25g disposable cartridges). Pathological indications are benign skin lesions such as: granuloma, derma fibroma, condyloma, genital lesions, molluscum contagiosum, seborrheic keratoses, actinic keratoses, warts on hands, warts on feet, lentigo, angiofibroma.
- Intended Users: The treatment of skin lesions is primarily reserved for dermatology. However, many of the everyday lesions can also be treated by other specialists. Cryosurgery has long been used in general medicine, pediatrics, gynecology, urology, surgery, etc. etc. Plantar warts are also removed in podiatry and age spots in cosmetology. Likewise, cryosurgery is used in dentistry and - as various studies show - in veterinary medicine. In general, it may only be used by appropriately trained specialists and the country-specific regulations must be observed in all cases.
This device is used directly on the patient. For this reason, you must read this manual carefully and strictly follow the instructions and notes contained therein! In case of doubt, contact your dealer or the manufacturer in Germany!
Working with your Cryoalfa®
- Inserting the N2O VALVE cartridge for SUPER & LUX:
Use only original Cryoalfa cartridges for commissioning the device! Unscrew the protective cap from the cartridge and remove the protective plug from the valve. Then screw the cartridge clockwise into the thread of the device until you feel a slight resistance. SCREW IN CAREFULLY AND DO NOT OVERTIGHTEN! The cartridge is equipped with a valve. It can be connected to and disconnected from the device without leaking gas. Empty cartridge must be replaced with new ones.
- Inserting the N2O-GEINDE capsule for PERFECT:
Protect your hands from icing with cold protection gloves when inserting! Also use protective goggles to protect your eyes! Take the device firmly in your hand, use the anti-slip cloth if necessary. Slowly unscrew the dispensing body counterclockwise and carefully put it aside. Now slowly unscrew the pressure relief valve (insert the hollow pin into the adapter body).
Do not bend over the device and hold the pressure relief valve away from you.
The gas now escapes through the pressure relief valve. The discharge noise ceases continuously until there is no more pressure in the capsule. The capsule can then be unscrewed with noticeable ease.
If you cannot unscrew the capsule with a light hand, it must be assumed that there is still considerable pressure in the capsule. Therefore, never try to unscrew the adapter from the capsule by force!
Check the underside of the adapter body see "Control image - for capsule replacement".
- Function test: A function test must be performed before each treatment. To check the amount of liquid gas flowing out, place the glass capillary directly on a gray cardboard and open the valve by pressing the lever for one second. The puddle of liquid that forms must have a diameter of at least 5-6mm. Do not use defective devices!
- Liquid Freezing" treatment method: Remove the protective cap from the glass tip. Place the device in the area of the lesion. The angle between the device and the treated area should be 65-90°. Apply N2O by pressing the lever on the dispenser.
- Treatment method "Contact Freezing": By pressing the lever on the applicator, the icing of the contact applicator begins. After about 15 seconds, the applicator has reached the working temperature of -50°C / -58°F, so you can start treatment. The iced contact applicator is pressed directly onto the lesion with pressure.
- Treatment duration: The treatment duration depends on the depth of the respective treatment. In the chapter Treatment Times, you will find more information about this.
- Cleaning: The device must be cleaned as soon as possible after use! The contact bodies must be cleaned/disinfected no sooner than 10 minutes after use. Remove the gas capsule! Remove surface contamination with a disposable/paper towel.
- Manual cleaning: Prepare the cleaning solution according to the manufacturer's instructions (e.g. Bomix 1%). Immerse the applicator in the cleaning solution. Make sure that the complete surface of the glass applicator is wetted with cleaning solution. Leave to react in the cleaning solution for at least 5 minutes. Remove the device from the cleaning solution. Place the device in a tub with water (at least drinking water quality) for at least 1 minute. Check the device for cleanliness; if contamination is still visible, repeat the aforementioned manual cleaning steps.
- Disinfection: Prepare the disinfection solution according to the manufacturer's instructions (e.g. Bomix plus 2%). Immerse the applicator in the disinfectant solution. Make sure that the complete surface of the glass applicator is wetted with disinfectant solution. Reaction time in the disinfectant solution according to the manufacturer's instructions for the disinfectant (e.g. Bomix plus 2%, 5 minutes). Remove the device from the disinfectant solution. Place the device in a tub of fully demineralized water for at least 1 minute. Repeat process with fresh fully demineralized water 1 x to completely remove the residues of the disinfectant. Wipe with a lint-free disposable cloth, or dry with medical compressed air.
- Disinfection in sterilizer: device sterilizer according to DIN EN 285 or small steam sterilizer according to DIN EN 13060, type B procedure.
Procedure: Steam sterilization with fractionated pre-vacuum, 34°C, holding time min. 3 min or 132°C min. 3min (longer holding times are possible). Place the wrapped products in the sterilization chamber. Start the program. At the end of the program, remove the products and allow to cool.
- Storage: Store the device in its original packaging when not in use. Make sure that the lever cannot be operated unintentionally during storage. Operating the lever will cause gas to escape.
Protect the gas cartridges from heat and direct sunlight. The capsule must never be exposed to temperatures above +50°C /+122°F.
Store the cartridges at a room temperature of 21°C / 70°F. Ensure that the tip is always protected by the cap.
- Disposal: Disposal must be in accordance with local regulatory requirements. Empty gas cartridges can be disposed of as scrap metal.
- Safety instructions and risks: The device may only be used for the purposes described in this document. Do not make any modifications to the device. Any modification to the device will void the warranty and liability claims.
The cartridges are under very high pressure. Strictly follow the safety instructions.
Never use a damaged device.
Devices that have accidentally fallen to the floor should be checked by the manufacturer before further use.
Do not apply pressure when assembling the individual components. When changing the cartridge, make sure that it is placed exactly straight on the thread and screwed in.
Warranty
The warranty is limited to the replacement of defective parts. Physical damage to the device caused by improper use and storage as well as non-compliance with transport regulations cannot be claimed. Furthermore, there are no warranty and liability claims in connection with lost working time, faulty handling, non-executed treatment and consequences thereof as well as in connection with the non-observance of safety instructions.
Treatment example wart
Mark the lesion to be treated with a circle. Measure the size of the lesion to be able to assess the treatment success at the following follow-up visit. Document this in the patient file.
Debride the wart until just before the bleeding point. For bleeding warts, we recommend using a homeostatic solution to stop the bleeding (applies to plantar warts only).
Position the patient in such a way that access to the lesion is as good as possible. The lesion to be treated should be directed directly upwards (towards the ceiling of the room).
Press the device lightly against the lesion to be treated. Activate the device by pressing the lever on the side. The angle between the device and the treated area should be 65-90°. Spraying from a greater distance has no effect.
The penetration depth into the skin tissue is about 1 mm per 3 seconds of icing time. The icing duration must be selected depending on the particular lesion being treated.
The icing starts immediately. At this moment, the patient may experience a feeling of shock or slight pain if many nerve endings converge in the treated area. During the treatment, a small area of healthy skin is always iced as well. About 5 minutes after the treatment, redness appears on the area that has turned white due to the icing.
In case of treatment on the sole of the foot, we recommend the application of a plaster after the treatment to relieve the treated area.
Schedule a follow-up examination after 2 weeks at the latest. In some cases, 2 to 3 treatments are required to eliminate warts or other lesions. For each individual treatment, follow the steps described.
Disclaimer
Improper use, including heavier than recommended icing levels or excessive icing duration, may result in physical injury to patients and operators of the device. Cryoalfa Europe GmbH, and its affiliates, officers, employees, agents, contractors and shareholders do not assume any responsibility or liability for death based on breach of contract, tort, strict liability, breach of warranty, failure to achieve a material purpose, breach of essential contractual obligations or any other legal grounds, physical or mental harm or injury, including consequential, incidental, direct, indirect, special, punitive or other damages, resulting from Cryoalfa products, their condition, specifications, possession or use. This applies even if such death, injury, loss or damage results from errors of judgment by Cryoalfa Europe GmbH or its affiliates, officers, employees, agents or contractors, and if such parties were aware of the possibility that damage might occur. You waive any and all liability to Cryoalfa Europe GmbH and its affiliates, officers, employees, agents, contractors and shareholders in connection with any damages, losses, costs, legal proceedings, fees, penalties and expenses (including expenses for legal representation). This includes, but is not limited to, liability claims relating to consequential, incidental, direct, indirect or special damages and fines, and liability claims at law and in equity arising out of suits, claims, legal actions, causes of action or legal proceedings relating to death, injury, loss or damage.
Contact / Orders
We distribute our products to selected dealers worldwide. If you are interested, please write to us at info@cryoalfa.de and we will name reliable distributors in your country.
You would like to distribute Cryoalfa products as a dealer? Then contact us at info@cryoalfa.de and we will send you the price list.
Order by eMail: order@cryoalfa.de