User`s Guide
Contents
1. Cryosurgery is contraindicated in patients with cryoglobulinemia Please consult literature for more information Relative contraindications Insecurity when making diagnosis of kind of lesions biopsy by skin carcinoma 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 the sun Freezing too deep especially peripherally on fingers toes wrist or the area behind the ear can theoretically give tissue damage It is recommended by multiple lesions that freezing is done only on one side of the finger or toe Lesions which in principal could be cryosurgically treated but also are infected should initially be medically treated for infection Incase of freezing nerves continued pains are possible Nerves or vessels can usually be protected by lifting folding or moving the lesional skin Treatment of areas on the head can provoke short headaches 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 with 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 fille2. thread perfectly straight when changing the cartridge 6 10 Warranty There is a 2 year warranty against technical defects The war ranty 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 working 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 high freezing speed which is a condition to obtain successful treatment Our cryosurgical devices are equipped with a specific liquid gas dosing applicator The operator is able to control the release of sufficent liquid N O to treat lesion without wasting gas With a temperature of 89 C 128 F the liquid gas is evaporating on the lesion This removes heat from the surrounding tissue and affects a freezing of the treated area This low temperature is converted to therapeutic energy with minimal loss As aresult of this process the tissue cells are destroyed permanently due to the cell mebrane 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
3. your Cryoalfa 6 1 Installation of cartridge N O Unscrew the protection cap of the cartridge and remove the small stopper Then screw clockwise the cartridge into the threads of the Cryoalfa body continue to turn until feeling a light stop position DO NOT USE FORCE The cartridge has a built in filter and valve and can be screwed or unscrewed without any gas loss When the cartridge is empty replace it with a new one 6 2 Operation Liquid Freezing Remove the protecting cap from the glass tip Bring the device into therapy position The device has to point in the direction of the therapeutical area By pressing the lever with the finger the liquid flow starts 6 3 Operation contact freezing By pressing the lever with the finger the contact tip starts to cool down After approx 18 sec the tip has reached 80 C 112 F and you are ready to start the treatment 6 4 Application range All typical indications occurring in medical practice like treatment of all types of warts haemangioma papilloma keratosis condyloma lentigo and more 6 5 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 time table 6 6 Cleaning The glass contact tip can be cleaned and disinfected with a disinfectant or alcohol In touch with blood mucous or any infected area itis mandatory to steam sterilize it Screw off the gas cartridge from the bod
4. 5 mm gold plated Contact surface applicator 27 mm gold plated Dental applicator 45 length 8 cm 04 mm Accesories for use with LUX PREMIUM CAP for Cryoalfa S CAP for Cryoalfa LUX Premium LED Light Cryoalfa Ref CA S CA S Cx CA L CA L Cx CA P CA P Cx CA K V16 4 CA K V25 4 CA M G5 CA M G9 CA M G13 CA M D1 CA M D2 CA M D3 CA M D4 CA M C3 CA M C5 CA M C7 CA M De CA Z SKa CA M SKb CA Z L 5 Models Lever Body Cartridge N O 16 or 25 gram RUD s tip SN Serial nr oie e n Contact tip Glas Cryoalfa SUPER aa Liquid Freezing Contact freezing Cryo Ref CA S Cryo Ref CA S C Cryoalfa LUX p Liquid Freezing Contact freezing Cryo Ref CA L Cryo Ref CA L C Cryoalfa PREMIUM pu Liquid Freezing Contact freezing Cryo Ref CA P Cryo Ref CA L C 5 1 Options for Model LUX amp PREMIUM Gynecology tip for Liquid Freezing Glass tip wide 4 mm length 50 90 130 MM Dentistry tip 45 C Glass tip wide 94 mm length 80 MM LED Light Available for all models using 16 gram cartridge does not fit Premium G13 G9 G5 De A Tip for Liquid Freezing Glass tip wide 21 2 3 4 mm length 22 mm D1 D2 D3 D4 4 Tip for contact freezing Contact surface 3 5 7mm c3 C5 C Cartridge 16 25 gram with valve Cartridge designed to work with the Cryoalfa SUPER LUX and PREMIUM Packed in box with 4 cartridges 6 How to work with
5. ce 89 C 128 F VATVOAUDS A1eDunso J9 JO Aem SANCAOUUI 9U SNIZ3324 GINO User s Guide Super LUX Premium 2015 Cryoalfa and Liquid Freezing are a registered trademarks of Cryoalfa Europe Ltd Q table of contents Chapter Page 1 Introductions and warnings 3 2 Legal 3 3 Used Symbols 3 4 Products 4 5 Pictures of products 5 6 6 How to work with Cryoalfa 7 8 7 Liquid Freezing 8 8 Medical Considerations 9 9 Suggested Freezing Times 10 10 Simple Treatment for Success 11 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 manufactured in the European Community by Cryoalfa Europe Ltd Bernhard Voss Strasse 25A 01445 Radebeul Germany Phone 49 351 795 1866 Fax 49 351 795 1803 E mail info cryoalfa com Website www cryoalfa com 2 D Document version UGENG201502A INDD 1 Introductions 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 N 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 ev
6. ce 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 The freezing effect is approx 3 mm deep and 8 10 mm diameter after 12 seconds The freezing result will vary depending on thickness of the skin type of lesion and freezing time Freezing starts immediately this can be seen by 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
7. d 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 Keep the treated area clean e Patient should not pick or scratch the treated area C h 9 Suggested freezing times 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 Ts 2 3 4 5 Hundeiker M Liquid freezing amp 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 amp A new approach f
8. entual risks prior 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 ad Manufacturer AN Warnings d Upper temperature limit 50 C Part number SN Serial number PZN 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 Super Liquid Freezing Cryoalfa Super contact freezing Cryoalfa LUX Liquid freezing Cryoalfa LUX contact freezing Cryoalfa Premium Liquid Freezeing Cryoalfa Premium contact freezing Cartridges with valve Cartridge 16 gram N O box of 4 pcs Cartridge 25 gram N O box of 4 pcs Applicators for use with LUX PREMIUM Cervix applicator length 50 mm 04 mm Cervix applicator length 90 mm 24 mm Cervix applicator length 130 mm 4 mm Dermatology applicator length 22 mm 01 mm Dermatology applicator length 22 mm 02 mm Dermatology applicator length 22 mm 03 mm Dermatology applicator length 22 mm 4 mm Contact surface applicator 3 mm gold plated Contact surface applicator 2
9. or 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 1 Dockery G Treating A Child With Multiple Mildly Pruritic Papules Podiatry Today 20 4 2007 Strumia R La Crioterapia in 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 sealing Place your device with a soft pressure against the lesion which is going to be treated Activate your devi
10. 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 treatment 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
11. y and sterilize the body and glass contact tip Use steam sterilizer at 134 C 273 F according to EN norms 13060 and 285 All other sterilization methods are excluded IN A hot air sterilization may damage the glass tip and must be avoided under all circumstances 6 7 Storage After use put the device back in the original packing in a way that the lever is not pressed by the cover otherwise gas escapes and empties the gas cartridge unintentionally gt lt Protect the gas cartridge from heat and direct sun expo U sure never expose the gas cartridge for a temperature above 50 C 122 F C Storage in 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 6 8 Disposal Disposal has to be done in a professional way and according to the country specific laws Empty gas cartridge may be disposed of as scrap metal 6 9 Safety instructions and risk Only use the device as described in the user s guide and 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 Observe the storage instruction since the gas cartridge is under pressure of 50 bar Never use a damaged unit Any device that has been dropped should be checked by us before it is used again Do not apply pressure when connecting the components Put on the feeder s
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