User Guide for Veterinaries (SUPER, LUX, PREMIUM)
Contents
1. 4 mm Dermatology applicator length 22 mm 1 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 O3 mm gold plated Contact surface applicator 25 mm gold plated Contact surface applicator 27 mm gold plated Dentistry applicator 45 length 80 mm O4 mm Accesories for use with LUX PREMIUM CAP for Cryoalfa Super Vet CAP for Cryoalfa LUX Vet Premium Vet LED Light 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 Veterinary Instruments Lever Body Cartridge N O 16 or 25 gram AP 3 Glass tip sN Serial nr Contact tip Cryoalfa SUPER Vet gom Liquid Freezing Contact freezing Cryo Ref CA S VET Cryo Ref CA S C VET Cryoalfa LUX Vet p Liquid Freezing Contact freezing Cryo Ref CA L VET Cryo Ref CA L C VET Cryoalfa PREMIUM Vet pu Liquid Freezing Contact freezing Cryo Ref CA P VET Cryo Ref CA P C VET 5 1 Options for Model LUX Vet amp PREMIUM Vet Long tips for Liquid Freezing Glass tips wide 94 mm length 50 90 130 mm Dentistry tip 45 C Glass tip wide 94 mm length 80 mm LED Light Available for all models with 16 gram cartridge exept for device premium G13 G9 G5 De A Tips for Liquid Freezing I Glass tips wide 1 2 3 4 mm 4 length 22 mm2. use the units Patients must be infor med about eventual 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 Manufacturer Warnings PE Upper temperature limit 50 C 1 Part number Serial number e L ec SN ZN Protect from direct sun exposure STERLE J Steam sterilization o494 Notified body nr 0494 SGS DE 3 C 4 Products This user manual is applicable for the following veterinary products and accessories Veterinary instrument Cryoalfa Super Vet Liquid Freezing Cryoalfa Super Vet Contact Freezing Cryoalfa LUX Vet Liquid freezing Cryoalfa LUX Vet Contact Freezing Cryoalfa Premium Vet Liquid Freezeing Cryoalfa Premium Vet contact freezing Cartridges with valve for veterinary use only Cartridge 16 gram N O box of 4 pcs Cartridge 25 gram N O box of 4 pcs Cryoalfa Ref CA S VET CA S Cx VET CA L VET CA L Cx VET CA P VET CA P Cx VET CA K V16 4 VET CA K V25 4 VET Veterinary applicators for use with LUX Vet PREMIUM Vet Long applicator length 50 mm 4 mm Long applicator length 90 mm 4 mm Long applicator length 130 mm
3. D1 D2 D3 D4 d Tips for contact freezing amp t C3 C5 QC Contact surface 23 5 7 mm Cartridge 16 25 gram with valve Cartridge N O desgined to work with the Cryoalfa SUPER Vet LUX Vet and PREMIUM Vet Packed in box with 4 gas cartridges 6 How to work with your Cryoalfa Vet 6 1 Installation of cartridge 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 towards the lesion By pressing the lever with the finger the flow of Nitrous Oxide begins 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 skin lesions in and out of mouth are approved to be treated with the Cryoalfa 6 5 Treatment time Treatment time depends on the depth at which the user deems necessary Please refer to the treatment guidelines included for more details 6 6 Cleaning Cleaning The glass contact tip can be cleaned and disinfected
4. Gena 89 C 128 F V User s Guide Super LUX Premium eONIZ334 AINON VITVOAW e AjeBunso 19 AiBuli9 9A 9SAneAOUU O 2015 SKAFTE medlab All trademarks are property of their respective owners Q table of contents Chapter Page 1 Introduction 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 Worldwide Distribution 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 UGENG201506AVET INDD 1 Introduction and Warnings Cryoalfa veterinary devices are intended for the controlled destruction of unwanted tissue by application of extreme cold using liquidfied N O N With this unit you will operate directly on the animal Therefore it 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 licensed specialists are allowed to
5. nit 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 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 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 T 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 recommendedto achieve maximum results This 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 Not getting expected result A No
6. result Treatment probably did not last long enough or the glass tip was to far away from the lesion 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 Follow up treatment suggestions e Showering and swimming are permitted Keep the treated area clean The animal should not pick or scratch the treated area 9 Suggested freezing times The veterinary literature has many reports of varying cryogenic freezing times Also the thickness location and hydration of the target tissue can affect outco mes Veterinary professionals should be familiar with cryosurgical techniques when using Cryoalfa e 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 animal journal Put the animal in such a way that you can easily treat the lesion If possible the Cryoalfa unit should be perpendicular to the lesion being treated 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
7. s 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
8. to get the best result Spraying at a distance has absolutely no effect max distance lt 1 mm 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 begins immediately The animal may feel a little discomfort due to the extreme cold However a treatment will never exceed 20 seconds limiting any severe discomfort Approximately 5 minutes after treatment a skin blush will appear over the treatment area 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 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 affiliate
9. 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 STERILE 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 N 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 Once closed make sure the lever is not being depressed Otherwise gas will escape unintentionally ce Protect the gas cartridge from heat and direct sun expo soc AN Never expose the gas cartridge to a temperature above I 50 C 122 F Store at room temperature 21 C 70 F Make sure that the tip is always protected by the cap 6 8 6 9 6 10 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 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 AN safety instructions Never use a damaged u
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