User`s Guide
Contents
1. The medical literature has many reports of varying cryogenic freezing times Also the thickness location and hydration of the target tissue can affect outco mes Medical professionals should be familiar with cryosurgical techniques when using Cryoalfa Although not exhaustive the table below contains suggested freezing times as reported in the literature These are wide ranges and provide only a guide line for consideration Literature freeze Type of lesion Time range in seconds Acne 4 6 Molluscum Contagiosum 3 10 Actinic Keratosis 4 8 Seborrheic Keratosis 5 10 Basiloma 8 9 Skin Tags 5 10 Cavernous Angioma 4 6 Verruca Juvenile 3 4 Condyloma 5 12 Verucca Plana 5 15 Granuloma Anulare 5 6 Verucca Plantaris 10 20 Keloids 4 6 Verruca Vulgaris 10 20 Lentigo 2 5 References for Liquid Freezing 1 2 3 4 5 Hundeiker M Liquid freezing in esthetical dermatology Dt Dermat 51 55 56 2003 Hundeiker M Sebastian G Bassukas ID Cyrotherapy guidelines for dermatology Bassukas ID Hundeiker M Liquid freezing A new approach for the cryosurgical treatment of superficial skin lesions Hundeiker M Simplified cryotherapy Daily practice 42 311 314 2001 Hundeiker M Bassukas ID Cryosurgery in Office Dermatology An Update 2005 References for cryosurgery in general i Dockery G Treating A Child With Multiple Mildly Pruritic Papules Podiatry Today 20 4 2007 Strumia R La Crioterapia in2. and reattach the dosing unit again tighten it slightly by hand Warning If you can not unscrew the gas cartridge with a light hand AN it must be assumed that the gas cartridge is still under pressure 6 2 6 3 6 4 6 5 6 6 6 7 6 8 Operation Liquid Freezing Remove the protective cap from the glass tip Bring the device into towards the lesion By pressing the lever with the finger the flow of Nitrous Oxide begins Operation Contact Freezing By pressing the lever with the finger the contact tip starts to cool down After approximately 18 sec the tip has reached 80 C 112 F and you are ready to start the treatment Application range All typical indications occurring in medical practice like treatment of all types of warts haemangioma papilloma keratosis condyloma lentigo and more Treatment time Treatment time lasts only for a few seconds depending on type and size of a lesion and is set at the discretion of the user See the time table in section 9 Cleaning The glass contact tip can be cleaned and disinfected with a disinfectant or alcohol If the device comes into contact with blood mucous or any other infected area it is mandatory to steam sterilize TsTere g Screw off the gas cartridge from the body and sterilize the body and glass contact tip Use a steam sterilizer at 134 C 273 F according to EN norms 13060 and 285 All other sterilization methods are excluded A N A hot ai
3. device in your hand and put the metal pin in the intended hole in the unit body This helps to grip the body without damaging the lever Screw the cartridge in a clockwise direction quickly and fully into the body of the unit Take care to align the cartridge straight and never to force the thread No noise of escaping gas should be heard whilst attaching the cartridge Thereafter the unit is ready for use Replacing the Cartridge For technical reasons a residual amount of gas remains in the car tridge To exchange the cartridge the following procedure must be followed Only change the gas cartridge if you are sure that it is not under pressure 1 Protect your hands from contact with gas liquid by using gloves when changing the cartridge Use also goggles to protect your eyes 2 Have the pressure release needle ready 3 Hold the device tightly in your hand you may use the anti slip cloth 4 Unscrew the dosing unit see the picture in section 5 slowly counterclockwise and carefully put it aside 5 Now screw the pressure release needle slowly insert hollow pin into the adapter Do not lean over the device doing this and keep the pressure release needle pointing away from you The gas escapes through the pressure release needle now The leaking noise will decrease in volume until there is no more pressure in the cartridge The cartridge can now be safely unscrewed 6 Unscrew the pressure release needle from the adapter
4. C 0494 89 C 128 F User s Guide PERFECT 2015 SKAFTE medlab All trademarks are property of their respective owners C table of contents Chapter Bo fan Q D 1 Introduction and Warnings 2 Legal 3 Used Symbols 4 Products 5 Pictures of products 6 7 8 9 1 D ONOKRKR WWW How to work with Cryoalfa Liquid Freezing Medical Considerations Suggested Freezing Times 0 Simple Treatment for Success _ O The most recent version of this user manual and other language versions can be downloaded from the manufacturer s website www cryoalfa com All mentioned products are Worldwide Distributon manufactured in the European SKAFTE Medlab AB Community by Apelrodsvagen 1 439 32 Onsala Cryoalfa Europe Ltd Sweden Germany Phone 46 300 56 94 94 Fax 46 300 56 94 99 E mail info cryoalfa com Website www cryoalfa com 2 Document version UGENG201502A INDD 1 Introduction and Warnings Cryoalfa devices are intended for the controlled destruction of unwanted tis sue by application of extreme cold using liquidfied N O With this unit you will operate directly on the patient Therefore it AN is mandatory to carefully go through the manual and to follow the instructions in detail If there are any doubts please consult your dealer or contact the manufacturer in Germany Only skilled specialists are allowed to use the units Patients must be infor med about eventual risks prio
5. Dermatologia Published by Business Enterprise SRL 2006 Dawber R Colver G Jackson A Cutaneous Cryosurgery Principles and Clinical Practice Martin Dunitz Publisher 3 d Edition 2005 Andrews M CryoSurgery for Common Skin Conditions American Family Physician 69 10 2365 2372 2004 Rubinsky B CryoSurgery Annual Review Biomedical Engineering 02 157 187 2000 Gage A What Temperature is Lethal for Cells J Dermatol Surg Oncol 5 6 1979 10 Simple treatment for success Draw a circle around the lesion to be treated Measure the size of the lesion to be able to see the treatment result by the next visit document in a patient journal Debride the wart to pinpoint bleeding If the wart is bleeding we recommend you to use homeostatic solution to stop the bleeding this point only valid for footwarts Put the patient in such a way that you easily can treat the lesion The lesion to be treated should point up against the ceiling Place your device with a soft pressure against the lesion which is going to be treated activate your device by pressing the lever on the side The angle against the treatment area should be 65 90 to get the best result Spraying at a distance has absolutely no effect For every 3 seconds of freeze the Cryoalfa is penetrating 1mm in depth of the skin The freezing times will vary depending on the particular lesion being treated Freezing starts immediately this can be seen b
6. e sun e Freezing too deep especially peripherally on fingers toes wrist or the area behind the ear can theoretically give tissue damage e It is recommended by multiple lesions that freezing is done only on one side of the finger or toe e Lesions which in principal could be cryosurgically treated but also are infected should initially be medically treated for infection e Incase of freezing nerves continued pains are possible Nerves or vessels can usually be protected by lifting folding or moving the lesional skin e Treatment of areas on the head can provoke short headaches e Please consult literature for more information other potential contraindi cations Not getting expected result A No result Treatment probably did not last long enough or the glass tip did not have contact or was to far away from the skin Snow and the ice crystals do not effect the result only the liquid placed directly on the skin Cryosurgery can normaly be repeated A second freezing can be applied after about one minute B A blister sometimes filled with blood may develop after the treatment Do not puncture the blister instead cover it with plaster or bandage In extreme cases this might lead to a scar formation or hyperpigmentation Follow up treatment suggestions e Showering and swimming are permitted e Keep the treated area clean e Patient should not pick or scratch the treated area h 9 Suggested freezing times
7. ing hours incorrect treatment and their consequences non executed after treatment and their consequences as well as the non observance of the safety instructions are excluded from all warranty and liability Liquid Freezing Cryoalfa Liquid Freezing provides a highly concentrated freezing for a suc cessful treatment Our cryosurgical devices are equipped with a specific liquid gas dosing applicator The operator is able to control the release of sufficient liquid N2O to treat lesions without wasting gas With a temperature of 89 C 128 F the liquid gas is evaporating on the lesion A freeze thaw freeze method is recommended to achieve maximum results AThis process causes the cells of the tissue to be destroyed due to the cell membrane rupturing as a consequence of ice crystal formation within the cell Please note According to clinical studies the freezing method Liquid Freez ing with N O is as efficient as liquid nitrogen N in most cryodermatologic indications 8 Medical considerations Absolute contraindications Cryosurgery is contraindicated in patients with cryoglobulinemia Please consult literature for more information Relative contraindications e Insecurity when making diagnosis of kind of lesions biopsy by skin carcinoma e Depigmentation as a side effect on dark skin can be cosmetically disturb ing On light skin depigmentation can hardly be seen and the skin tends to recover after exposure to th
8. nt procedures and whether or not any such death injury loss damage s result from the negligence default or error in judgment by Cryoalfa Europe LTD their affiliates respective directors officers sha reholders employees agents and contractors and even if advised of the possibility of such damages You agree to indemnify Cryoalfa Europe LTD their affiliates respective directors officers shareholders employees agents and contractors from and against any and all liability damages losses costs judgments fines penalties and expenses including legal expenses of any kind or nature including without limitation incidental consequential indirect special or punitive damages arising out of claims demands actions causes of action proceeding or suits whether in law or in equity due to any death injury loss damage or damages as hereinbefore referred to
9. r sterilization may damage the glass tip and must be avoided under all circumstances Storage After use put the device back in the original packing Once closed make sure the lever is not being depressed Otherwise gas will escape unintentionally gt lt Protect the gas cartridge from heat and direct sun expo a sure Never expose the gas cartridge to a temperature above 50 C 122 F Store at room temperature 21 C 70 F Make sure that the tip is always protected by the cap Keep the device out of the reach of children and unauthorized users Disposal Disposal must be conducted in accordance with local require ments Empty gas cartridge may be disposed of as scrap metal C 6 9 Safety instructions and risk Only use the device as described in the user s guide for the purpose specified therein Do not try to modify the device Any manipulations of the device will result in an exclusion of warranty and liability Cartridges are under extreme pressure Follow all suggested safety instructions Never use a damaged unit The manufacturer should check any device that has been dropped before it is used again Do not apply pressure when connecting the components Put on the feeder s thread perfectly straight when changing the cartridge 6 10 Warranty The warranty is strictly limited to the exchange of defective parts Dropped devices or broken tips are not under warranty Other claims for damages such as loss of work
10. r to start the treatment 2 Legal Cryoalfa is the registered trademark of Cryoalfa Europe LTD Liquid Freezing is the registered trademark of Cryoalfa Europe LTD Notified Body Number 0494 Patented technology in USA Canada China Hong Kong Japan and also other international patents pending Please also note the liability waiver at the back of this manual 3 Used symbols atal Manufacturer A N Warnings ee Upper temperature limit 50 C Part number SN Serial number a Protect from direct sun exposure STERILE J Steam sterilization C 0494 Notified body nr 0494 SGS DE 3 4 Products This user manual is applicable for the following products and accessories Instrument Cryoalfa Ref Cryoalfa Perfect Liquid Freezing CA Pr Cryoalfa Perfect Contact Freezing CA Pr C Cartridges without valve Cartridge 16 gram N O box of 4 pcs CA K G16 4 Cartridge 25 gram N O box of 4 pcs CA K G25 4 Accesories for use with Perfect CAP for Cryoalfa Perfect CA Pr SKa Pin for tighting gas cartridge Perfect CA Z P O ring for Perfect CA Pr Or Liquid Freezing Contact freezing Cryo Ref CA Pr Cryo Ref CA Pr C 5 Models Lever Body Cartridge N O 16 or 25 gram Cap D Glass tip Dosing unit SN Serial nr Contact tip Dosing unit Pressure release needle mm This page contains no infomation 6 How to work with your Cryoalfa 6 1 Attaching the Cartridge Take the
11. y a whitening of the skin From this moment the patient could feel a shooting feeling or sometimes a slight pain if there are many nerve endings turned downwards in the treated area Even a small part of healthy skin shall be treated during this process Approx 5 minutes after the treatment is completed a skin blush will replace the part which was coloured white by the freezing treatment If treatment has been done on the footpad we recommend a plaster on the area to relieve the treated area Reserve a time for next visit within 2 weeks Sometimes 2 to 3 treatments are necessary before the wart lesion is removed By each treatment occasion the prescribed procedure should be taken Liability waiver Improper use including excess freezing levels beyond those which are recommended or for an excessive duration may result in bodily injury to clients patients or to operator Cryoalfa Europe LTD and their affiliates respective directors officers shareholders employees agents and contractors are not liable or responsible regardless of whether such liability or responsibility is based on breach of contract tort strict liability breach of warranties failure of essential purpose fundamental breach or otherwise for any death or injury whether physical or mental or for any incidental consequential indirect special or punitive damages arising out of the Cryoalfa products its design specifications possession and use and treatme
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