CRYOALFA PERFECT Cartridge Instruction Manual
- July 29, 2024
- CRYOALFA
Table of Contents
CRYOALFA PERFECT Cartridge
Product Information
Specifications
- Product Name: CRYOALFA ORIGINAL
- Origin: Made in Germany
- Manufacturer: Cryoalfa Europe GmbH
- Address: Bernhard-Voss-Str. 25a, 01445 Radebeul, Germany
Product Usage Instructions
Introduction and Purpose
To treat lesions using CRYOALFA ORIGINAL, follow these steps:
- Purpose: The devices in the Cryoalfa range are reusable devices designed for the controlled elimination of pathologically altered tissue through the application of extreme cold caused by liquid N 2 O (nitrous oxide, supplied in 16 g or 25 g disposable capsules) Pathological indications are benign skin lesions such as granuloma, dermatofibroma, condyloma, genital lesions, molluscum contagiosum, seborrhoeic keratoses, actinic keratoses, warts on the hands, warts on the 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, paediatrics, gynaecology, urology, surgery, etc Plantar warts are also removed in podiatry and liver spots in cosmetology Cryosurgery is used as well in dentistry and as various studies show in veterinary medicine In general, the device may be used only by appropriately trained personnel and the country-specific regulations must always be observed.
This device is used directly on the patient. For this reason, you must read this manual carefully and strictly follow the instructions and notes it contains! If in doubt, contact your dealer or the manufacturer in Germany!
Legal Notice
Cryoalfa® is a registered trademark of the company Cryoswiss GmbH. Liquid
Freezing® is a registered trademark of company Cryoswiss GmbH.
- 0494 Number of the notified body: 0494
Please refer to the disclaimer on the back of this manual.
Symbols Used
Products
These operating instructions apply to the following products and accessories:
Devices Cryoalfa
- Cryoalfa Perfect CA-Pr
- Cryoalfa Perfect Contakt Ø 3mm CA-Pr-C3
- Cryoalfa Perfect Contakt Ø 5mm CA-Pr-C5
- Cryoalfa Perfect Contakt Ø 7mm CA-Pr-C7
Applicators für Perfect
- Standard applicator Ø1mm CA-Pr-DST
- Contakt applicator Ø 3mm CA-Pr-T/C3
- Contakt applicator Ø 5mm CA-Pr-T/C5
- Contakt applicator Ø 7mm CA-Pr-T/C7
Gas cartridges with thread
- 16g N2O cartridges with thread CA-K-G16
- 25g N2O cartridges with thread CA-K-G25
Further accessories
- Protective cap CA-L-SKa
Product Images
Control image – for capsule replacement
Check the underside of the device each time you change the capsule! If there
are any discrepancies, do not screw a new cartridge into the device under any
circumstances! If in doubt, contact your dealer or the manufacturer in Germany
!
To avoid known risks, please note the following relative contraindications:
- Areas of the body with generally delayed wound healing such as the shins
- Hairy skin areas
- Treatment sites where the skin cannot be lifted off over superficial nerves, e.g.. on the outer sides of the fingers
- In case of multiple lesions, it is recommended to ice only one side of the finger or toe
- (Highly) Pigmented skin
Working with your Cryoalfa ®
Commissioning the device Protect
your hands from freezing with cryoprotection gloves! Also use safety glasses
to protect your eyes! Please also note the product images on page 6 Hold the
device firmly in your hand Use the anti slip cloth if necessary Slowly unscrew
the dispenser body anti clockwise and carefully put it to one side Now insert
the cartridge screw the cartridge quickly and completely clockwise into the
adapter body Insert the clamping pin into the hole provided in the adapter
body and tighten the connection! If it hisses (typical gas sound), you need to
tighten the cartridge a bit more! Screw the dispenser body back onto the
device in a clockwise direction
Cartridge change
Protect your hands from freezing with cryoprotection gloves! Also use safety
glasses to protect your eyes! Hold the device firmly in your hand Use the anti
slip cloth if necessary Slowly unscrew the dispenser body anti clockwise and
carefully put it to one side Now slowly unscrew the pressure relief valve
(insert the hollow pin into the adapter body)
- Hold the pressure relief valve away from you and do not lean over the device
The gas now escapes through the pressure relief valve The sound of escaping gas continues until there is no more pressure in the capsule After that, the cartridge can be unscrewed easily
- If you cannot unscrew the cartridge with a light touch, it must be assumed that there is still considerable pressure in the cartridge Never use force to unscrew the adapter from the cartridges!
Check the underside of the adapter body as described on page 4 ,,”Control image for cartridges replacement” Then proceed as described in point 6 1
Function test: A function test must be carried out before each treatment To check the amount of liquid gas flowing out, place the glass capillary directly on a piece of greyboard and open the valve for one second by pressing the lever The resulting pool of liquid must have a diameter of at least 5 6 mm Never use defective devices!
Liquid Freezing“ treatment method: Remove the protective cap from the glass tip Position the device in the area of the lesion The angle between the device and the area to be treated should be 65 90 N 2 O applied by pressing the lever on the dispenser.
“Contact Freezing“ treatment method: Pressing the lever on the applicator starts the icing of the contact applicator. After about 15 seconds, the applicator reaches the working temperature of -50°C/ -58°F, so you can start the treatment. The iced contact applicator is pushed directly onto the lesion with pressure.
Treatment duration: The duration of treatment depends on the depth of of each treatment. You will find more information about this in the Treatment times of Chapter.
Cleaning: The device must be reprocessed as soon as possible after it has been used! The contact bodies may not be cleaned/disinfected for at least 10 minutes after use. Remove the gas capsule! Remove surface contamination with a disposable/paper towel.
Manual cleaning: Prepare the cleaning solution in accordance with the manufacturer’s instructions (e.g., Bomix 1%). Immerse the applicator in the cleaning solution. Make sure that the entire surface of the glass applicator is wetted with cleaning solution. Immerse in cleaning solution for at least 5 minutes. Take out the device from the cleaning solution. Place the device in a tub of water (at least drinking water quality) for at least 1 minute. Check the device for cleanliness. If dirt is still visible, repeat the manual cleaning steps mentioned above.
Disinfection: Prepare the disinfectant solution in accordance with the manufacturer’s instructions (e.g., Bomix plus 2%). Immerse the applicator in the disinfectant solution. Make sure that the entire surface of the glass applicator is wetted with disinfectant solution. Exposure time in the disinfectant solution in accordance with the manufacturer’s instructions for the disinfectant (e.g., Bomix plus 2%, 5 minutes). Take out the device from the disinfectant solution. Place the device in a tub of demineralised water for at least 1 minute. Repeat the process once with fresh demineralised water to completely remove the residues of the disinfectant. Wipe with a lint-free disposable cloth, or dry with medical compressed air.
Disinfection in the steriliser: Device Steriliser according to DIN EN 285 or small steam steriliser according to DIN EN 13060, type B Procedure
Procedure: Steam sterilisation with fractionated pre-vacuum, 34°C, holding time minimum 3 mins or 132°C minimum 3 mins (longer holding times are possible). Place the wrapped products in the sterilisation chamber. Start the programme. At the end of the programme, remove the products and leave 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 capsule from heat and direct sunlight. The cartridge must never be exposed to temperatures above +50°C / +122°F.
Disposal: must be carried out in accordance with local legal .. requirements. Empty gas capsules can be disposed of as scrap metal
Safety instructions and risks: The device may be used only for the purposes described in this document. Do not make any changes to the device. Any modification of the device will void the warranty and liability claims.
- The cartridges are very highly pressurised. Strictly follow the safety instructions.
- Never use a damaged device. Devices that have accidentally fallen to the ground sholuld be checked by the manufacturer before further use.
Do not apply pressure when assembling the individual components. When changing the capsule, make sure that it is placed on the thread and screwed in perfectly straight.
Warrenty: The warranty is limited to the replacement of defective parts. Claims cannot be made against physical damage to the device caused by improper use or storage or non-compliance with the transport regulations. Furthermore, there are no warranty or liability claims in connection with lost work time, incorrect handling, treatment not carried out and the consequences thereof, or in connection with the non-observance of safety instructions.
Liquid Freezing®
Cryoalfa® Liquid Freezing® provides a fast freezing rate, which is a condition for successful treatment. The Cryoalfa cryosurgical devices are equipped with a special liquid gas dispenser. The devices allow the controlled, lossless delivery of liquid N2O. The liquid gas vaporises at a temperature of -89°C / – 128°F on the treated skin lesion. For best results, a freeze-thaw-icing method is recommended. In this process, cells are destroyed by rupturing of the cell membrane due to the formation of ice crystals inside the cell.
Please note: According to clinical studies, the “Liquid Freezing®” method with N2O is as efficient as liquid nitrogen (N2) in most cryodermatological indications.
Medical Advice
General recommendation
cryosurgical procedure may cause pain or a burning sensation on the skin
Acceptance of the treatment can be significantly improved if patients are
informed about the possible occurrence of pain, the planned number of
treatments, any preparatory treatments that may be required, as well as
possible side effects, follow up treatments and possible risks of recurrence
Absolute contraindications
Cryosurgery/cryotherapy is contraindicated in persons with a known intolerance
to the refrigerant N 2 O or a general intolerance to col
Absolute contraindications are:
- Cold urticaria
- Cryoproteinemia , cryofibrinogenemia , cryoglobulinemia, agammaglobulinemia
- Dyscrasia of unknown cause
- (Drug) Immunosuppression
- Multiple myeloma
- Pyoderma gangraenosum
- Arterial occlusive diseases
The following lesions must not be treated with Cryoalfa devices due to their possible depth extension
- Cancerous tissue, malignant changes/tumours
- Unexplained, conspicuous liver spots/moles
Relative contraindications
Special care should also be taken with:
- Autoimmune diseases such as collagenosis or lupus erythematosus
- Raynaud’s syndrome (intermittent paling of the fingers or toes)
- Wound healing disorders, e.g., due to circulatory disorders, diabetes mellitus, old age.
- Currently undergoing chemotherapy or radiotherapy
- Acute febrile infection
In these cases the Cryoalfa devices may only be used after careful consideration of the risk benefit ratio by a physician Further information can be found in the relevant literature
To avoid known risks,please note the following relative contraindications contraindications:
Risks and effects
Cryotherapy is one of thw low-risk treatment methods, but side effects can
still occur during treatment.
These include:
- Oedema, blistering
- Bleeding
- Local pain (also headache in the case of treatments in the head area)
- Cartilage damage during treatment of the nose an ears
- Infections, ulcerations
- Milia
- Flat or atrophic scars
- Hair and hair follicle loss (alopecia)
- Pigmentation disorders (hypo/hyper-pigmentation)
- Nerve damage, sensory disturbances
Recommendations for follow-up care – Patient information
Keep the treated area clean. Swimming and showers are allowed. Patients should
avoid touching or scratching the treated area if possible. Any blisters that
may have formed should be protected with a plaster/bandage and never picked
open. Fresh treatment sites should not be exposed to the sun.
Undesirable/ unsatisfactory treatment results
- No discernible treatment success: The treatment was not performed for long enough, the tip was not in contact with the lesion or the tip was too far from the skin. The treatment effect does not result from the formation of crystals, but from the liquid gas contacting the skin. Cryosurgical treatments can usually be repeated. A second icing procedure can be performed about one minute after the first.
- Blood-filled blisters may form after treatment. Do not puncture such blisters, but cover them with plaster or bandage. In extreme cases, scarring or hyperpigmentation may occur.
Treatment Example – Wart
- Mark the lesion to be treated with a circle Measure the size of the lesion to assess the success of treatment at the next follow up visit Document this in the patient record
- Debride the wart until just before the point of bleeding For bleeding warts, we recommend the use of a haemostatic solution to stop the bleeding (applies only to foot warts)
- Position the patient to allow the best possible access to the lesion The lesion to be treated should be turned 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 area to be treated 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 duration of icing must be chosen depending on the lesion being treated
- The icing starts immediately At this moment, the patient may experience a sensation of shock or mild 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
- For treatments on the sole of the foot, we recommend applying a plaster after treatment to protect the treated area
- Schedule a check up after 2 weeks at the latest In some cases, 2 to 3 treatments are required to remove warts or other lesions The steps described must be carried out for each individual treatment
Recommended Treatment Times
Different icing durations are recommended based on the tissue type being
treated. The medical literature recommends different icing durations for
cryosurgical treatments. Thickness, position and moisture content of the
tissue to be treated have an influence on the treatment result. Medical
professionals using Cryoalfa must have experience with cryosurgical treatment
methods. The following table contains example recommendations for icing
duration taken from the specialist literature. The figures allow for a great
deal of leeway in decision-making and are intended only as a guide.
Literature.
- Prof. Dr. med. Prof.h.c. Dr.h.c.CC. Zouboulis, Cryosurgery in dermatology, Der Hautarzt, issue 11/2015
- Strumia, Renata, La Crioterapia in Dermatologia, Published by Business Enterprise SRL, 2006.
- Hundeiker M, Bassukas ID, “Cryosurgery in Office Dermatology” An Update, 2005. Andrews, Mark, Cryosurgery for Common Skin Conditions, American Family Physician, 69:10, 2365-2372, 2004.
- Rubinsky, Boris, Cryosurgery, Annual Review Biomedical Engineering, 02:157- 187, 2000.
- Dawber, Rodney, Colver, Graham, et al, Cutaneous Cryosurgery: Principles and Clinical Practice, Martin Dunitz Publisher, 2nd Edition, 1997.
- Setrag A. Zacarian, Cryosurgery for Skin Cancer and Cutaneous Disorders 1985. . Gage, Andrew, What Temperature is Lethal for Cells? J Dermatol Surg Oncol, 5-6, 1979
Refer to the table below for guidance:
| Indication | Freezing Time Range (in seconds) | Literature |
|---|---|---|
| pedunculated warts | 5-10 | 4,6 |
Treatment example wart
- Mark the lesion to be treated with a circle Measure the size of the lesion to assess the success of treatment at the next follow up visit Document this in the patient record
- Debride the wart until just before the point of bleeding For bleeding warts, we recommend the use of a haemostatic solution to stop the bleeding (applies only to foot warts)
- Position the patient to allow the best possible access to the lesion The lesion to be treated should be turned 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 area to be treated 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 duration of icing must be chosen depending on the lesion being treated
- The icing starts immediately At this moment, the patient may experience a sensation of shock or mild 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
- For treatments on the sole of the foot, we recommend applying a plaster after treatment to protect the treated area
- Schedule a check up after 2 weeks at the latest In some cases, 2 to 3 treatments are required to remove warts or other lesions The steps described must be carried out for each individual treatment
Disclaimer
Improper use, including more icing than recommended or excessive icing time,
can result in physical injury to patients and equipment operators. Cryoalfa
Europe GmbH, and its affiliates, officers, employees, agents, contractors and
shareholders assume no responsibility or liability for death, physical or
mental damage or injuries, including consequential, incidental, direct,
indirect or special damage, punitive or other damage attributable to Cryoalfa
products, their condition, specifications, possession or use, based on breach
of contract, tort, strict liability, breach of warranty, failure to achieve a
material purpose, breach of essential contractual obligations or other legal
grounds. This applies even if such death, injury, loss or damage results from
errors of judgement by Cryoalfa Europe GmbH or its affiliates, officers,
employees, agents or contractors, and even if such parties were aware of the
possibility that damage might occur. You waive any and all liability claims
against Cryoalfa Europe GmbH and its affiliates, officers, employees, agents,
contractors and shareholders for any damage, losses, costs, legal proceedings,
fees, penalties and expenses (including legal representation expenses). This
includes but is not limited to liability for consequential, incidental,
direct, indirect, special and punitive damage, and liability at law or in
equity arising out of any action, claim, suit, cause of action or legal
proceeding relating to death, injury, loss or damage.
All products listed in this document are manufactured in the European Union by:
Cryoalfa Europe GmbH
Bernhard Voss Str. 25a
01445 Radebeul
Germany
Telefon: +49 351 795 1866
Fax: +49 351 795 1803
E-Mail: info@cryoalfa.de
Website : www.cryoalfa.de
FAQ
Q: How many treatments are typically needed to remove warts?
A: In some cases, 2 to 3 treatments may be required to completely remove
warts or other lesions.
Q: What should I do if the treated area shows redness post-treatment?
A: It is normal for redness to appear on the area that has turned white due
to icing. If the redness persists or worsens, consult a healthcare
professional.
References
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