Cryo Mini User`s Manual
Contents
1. 9761 291 Fax 49 0 731 9761 299 www zimmer de export zimmer de Manufactured for Zimmer MedizinSystems 25 Mauchly Suite 300 Irvine CA 92618 800 327 3576 949 727 2154 fax www zimmerusa com info zimmerusa com 222. spirit is recommended To disinfect the unit and its attachments use commercial equipment disinfectant in accordance with its manufacturer s instructions The condensate collector should be disinfected each time it is emptied using a commercial disinfectant N 14 Advice on treatment and use gt gt gt gt gt gt gt gt To treat larger areas the distance from the nozzle to the skin should be increased resulting in longer treatment times for adequate cooling At a distance of 5cm the cooling spot covers app 10cm Hygienic gloves should be worn during the treatment Before treatment the purpose and effect of cryotherapy using CryoMini should be explained to the patient Advise the patient to report any adverse reactions during treatment e g extreme cold sensations immediately to the practitioner Throughout the treatment the practitioner should check the wellbeing of the patient by asking appropriate questions If necessary adjust the treatment parameters air flow rate distance from treatment area For use in conjunction with laser equipment a distance of 2 inches bcm is recommended for a treatment area of 4 square inches 10cm Larger areas should be treated using a correspondingly larger distance In such cases a longer treatment time is necessary to achieve the required cooling Zimmer 15 UL Classification The device bears the following UL Mark SSIF e US CLASSIFIED BY UND
3. 1 4 Device Configuration Use this submenu to change the language used in the displays or to make technical adjustments Use the arrow and Select keys to choose the desired option Display Contrast Start sequence Language Display Backlight Display Contrast OK did Start Stop OC figure 9 gt Language Various languages are available these include German English French Italian and Spanish gt Display Backlight The time to elapse before entering standby mode dimming of display may be adjusted under this menu Use the arrow keys 13 14 to select a period between 0 and 300 seconds The factory preset value is 180 seconds Press Store 11 to apply and save the new setting Delay time prior to screen saver Alternative 0 gt no screen saver o 1 300 sec 180 OK Start Stop a figure 10 Standby mode saves unnecessary wear on the display and so prolongs its working life Zimmer gt Display Contrast Use the setting to adjust the brightness of the display between 10 maximum contrast to 23 very low contrast Setting of Display Contrast e Contrast Value 0 23 OK Start Stop figure 11 4 1 5 Default Settings Select either YES or NO 11 12 No other option is available If YES is selected all settings are returned to their original default values Start Stop OK Reset default configuration Oe Oe figure 1
4. 2 4 1 6 Service This option is password protected and accessible only by personnel trained by Zimmer MedizinSysteme To leave this menu option press OK 15 Please enter passwort e figure 13 4 1 7 Defrosting Defrosting begins immediately the Defrost program is selected It can be cancelled by pressing the Back key 12 The evaporator is defrosted d Defrost mode activated Ce e 9 OK Start Stop figure 14 11 Zimmer 4 1 8 Back to Treatment This option exits the menu and returns to the treatment display Zimmer 5 Start of treatment Therapy screen Start Stop figure 15 After pre cooling the CryoMini is ready for treatment Pressing the Start Stop button starts treatment 6 End of treatment When the program time has elapsed the air supply is cut off and an acoustic signal is emitted The program can also be ended manually by pressing the Start Stop key 16 7 Time setting Times between 00 00 and 99 59 minutes may be set Pressing the up or down key once increases or decreases the treatment time for 1 minute By holding the up or down key increases or decreases the treatment time in steps of 10 minutes If an excessively long time has been inadvertently set pressing the Start Stop key 16 twice will revert the system to the factory preset time for the program which in some cases will help speed up the process of adj
5. ERWRITERS LABORATORIES INC WITH RESPECT TO ELECTRIC SHOCK FIRE MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL 60601 1 AND CAN CSA C22 2 NO 601 1 1KD1 20 Zimmer 16 Parts included accessories Only authorized accessories should be used Accessories delivered with unit 1 User Manual 1 Lightweight tube for laser treatments 1 Container for defrosted water Available Accessories Lightweight tube for laser treatments Container for defrosted water Castors 275 mm Angel adaptor for laser therapy Reduction nozzle 5mm Reduction nozzle 10mm Reduction nozzle 15mm 17 Safety and Maintenance CryoMini is manufactured in accordance to VDE 0750 part 1 DIN EN 60601 1 safety regulations As the manufacturer Zimmer MedizinSysteme GmbH assumes responsibility for the safety and reliability of the unit only on the following conditions gt that the unit is supplied from an electrical socket with safety contact that meets all regulations and the electricity supply conforms to DIN VDE 0100 part 710 gt that the unit is operated in accordance with the instruction manual gt that any expansions readjustments or modifications are carried out exclusively by personnel acting on behalf of Zimmer MedizinSysteme GmbH The unit contains no user serviceable parts with the exception of the air filter 8 chapter 8 1 page 17 and the condensate collector 7 chapter 8 2 page 17 17 1 Functional self test On switch on CryoM
6. a Physical dimensions External dimensions Castors with diameter Maximum load to be placed on the table surface 120 V 50Hz 60Hz SN 400300 401999 standby 1A maximum 8 10A 16A circuit breaker in power on off switch Type B accordance with 601 1 3 14 F 150 F max 10 C 70 max 600 1200hPa 32 F 86 F max 0 C 35 max 700 1200hPa 12V Protection Multifuse 500mA 12V Protection Multifuse 50mA minimum standby 4 F 20 C maximum standby 14 F 10 C maximum operating 23 F 5 C Air temperature at nozzle ambient temperature 77 F 25 C or less average 14 F 10 at start of treatment 4 F 20 C maximum 23 F 5 C after 15 min treatment Level 1 250 l min Level 2 440 l min Level 3 627 l min Level 4 780 l min Level 5 910 l min Level 6 1050 l min Level 7 1150 l min Level 8 1250 l min Level 9 1350 l min 99 59 minutes Weight 35 5kg 650x335mmx600mm HxWxL 7omm lass plate Equipment e g lasers with a maximum weight of 65lbs 30kg and maximum dimensions 20x20x19inches 50x50x48cm WxDxH may be placed on any plate fixable on the Stand offs 18 Zimmer 13 Cleaning of exterior and disinfection of unit gt Clean the exterior of CryoMini with commercial synthetic cleaner or furniture polish but not alcohol based gt gt gt For the glass table surface and the treatment tube alcohol or
7. e collector vessel which holds about 2 liters and may be removed for emptying The vessel should be cleaned after emptying and then placed back in the device CryoMini should not be operated with the collector removed Zimmer 9 Models parameters and adjustments to preset values Models gt Preset parameters gt Adjustments to preset parameters Different models are available to suit different power supply voltages Each unit leaves the manufacturer with a set of standard parameters preset These may be restored at any time by selecting the Main Settings function see Adjustments Settings and Menus above CryoMini allows the airflow and treatment time to be adapted to suit specific requirements and for the new values to be saved in the unit s memory see Adjustments Settings and Menus 1 Air flow rate treatment fan can be adjusted through nine levels 2 Treatment time Treatment time may be adjusted between 00 00 and 99 59 minutes Zimmer 10 Indications Contra indications for use in conjunction with laser treatment 10 1 Indications The CryoMini Cold Air Device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anaesthetic relief for injections 10 2 Contra Indications Hyper sensitivity to cold Areas of impaired sensation Areas of impaired circulation Open wounds Ablative laser treatment Frostbite Raynaud disease C
8. ini performs an automatic self test and checks the operation of its various components If necessary the operation of the cooling system may also be checked as follows 1 Switch the unit on 2 Wait until unit reaches its ready state This is indicated when the therapy menu appears see Adjustments Settings and Menus 3 Pressthe Start Stop button 16 to start operation 4 Select the various air flow levels and check the air flow rate and cooling achieved 21 Zimmer 18 Fault signals Error and fault signals appear in text form on the display in some cases a possible cause is indicated In some cases the error is self correctable after the device has been switched off In this case wait a few seconds and switch the device back on If the error indication is still displayed after switching the device back on contact customer service In the event of Error High temperature cooling circuit switch off the device and wait 30 minutes before switching on again Certified Service Personnel can be reached by contacting the sales representative or by contacting Zimmer MedizinSysteme directly When the expulsed air or air volume temperature is decreasing defrosting is necessary 19 Disposal The unit must be disposed of through an accredited company and should under no circumstances be placed in the ordinary or bulk waste Manufacturer Zimmer Medizinsysteme GmbH Junkersstrasse 9 D 89231 Neu Ulm Tel 49 0 731
9. ll be stored as a reserve The Minimal Load of the CryoMini begins to be created as soon as the device is switched on This phase is characterized by the simultaneous working of the compressor and the Condenser fan These 2 elements are always functioning together During the Minimal Load no functions are available and the display indicates the status of loading figure 7 no treatment is possible When the unit has reached its minimal cold temperature you can start the therapy The compressor and Condenser fan still runs and now produce the Additional or Total Load The Total Load Additional The Total Load refers to the steady maintenance of the maximum cold temperature in the cold reserve For example During a treatment Starting of the therapy fan with the Start Key the compressor and the condenser fan run automatically in order to compensate for the loss of cold capacity When the therapy fan stops end of treatment the compressor and condenser fan will continue running in order to complete the cold reserve During this loading period treatment is possible Afterwards the unit remains in Stand By Mode The Stand by If the device is not used for approximately 30 minutes in Stand by Mode the cold reserve will naturally loose part of its capacity The compressor and condenser fan will then start running in order to complete the cold reserve During the Stand by Mode treatment is possible Cold reserve additions are made automatica
10. lly The frequency required to maintain an adequate cold reserve will vary according to the surrounding climatic conditions Important Advice for Optimal Use The first treatment should be made after the cold reserve is complete or Total Load and not after the Minimal Load Otherwise the possibility exists that the unit may not have enough cold reserve for subsequent treatments it would then automatically proceed to the Minimal Load and treatment would not be possible for a few minutes Zimmer 2 Assembly instructions e Step 1 Treatment tube 6 Attach the treatment tube to the air outlet of the CryoMini 5 figure 1 figure 5 e Step2 Angle adaptor Attach the accessory storage box through the felt on the top of the unit If included Zimmer 3 Operating instructions 1 Switch unit on Power on 9 the treatment display is illuminated 2 Operating status and Therapy While start up the display indicates the current status e g self test pre treatment cooling The unit is ready for use once the treatment display is lit After the pre cooling phase the device releases the therapy screen You now can directly select the desired fan speed and therapy time Pressing the otart Stop button starts the therapy Start Stop figure 6 3 Endoftreatment The end of the program whether automatically the cold air supply is cut off or by the operator having pressed the Start Stop button is indicated with an acou
11. owing maintenance work or after being transported on its side CryoMini must be left in the upright position for a minimum of 30 minutes before being switched on to avoid damage to the compressor Zimmer Content eC i a ee 5 2 ole alas le Rad MAS DNI MM T SM ONS mm 8 4 Adjustments settings and MONUS ccccccsscsssssssssssssssssssesssssscssscsssesasscssoesacscsssesesacsesesesacsusesesansesssesausessaesesaeessesesanenaess 9 41 TNE MENU options in detail 2 ec scsescsssssecsesecsssesecseseecsesesecsesesassesesscsesessesesassesesaesesesaesesassesesaesesasseeesaeesasess 10 4 1 1 lo me 10 4 1 2 Automatic Service Program S01 ccssesssssssssssssssssssessssssssssssssssssessessesssssssesesseesessssesessseseesesesesseaeeeeness 10 4 1 3 Automatic Service Program eol Zr 10 4 1 4 Device een ee 10 4 1 5 BEERS ae ee A ERRATA 11 4 1 6 Jui ATI 11 4 1 7 DC 11 4 1 8 Back to redime 12 Di SCOENE E triennio 13 ME ENOTE MEN RR 13 i TES tcx 13 0 Maintenance UID UIN EDDIE EIDEM CDD DUM DIM DEDE M MADE E MEME 14 0 1 Service elements rear panel ennemi tnra 14 0 2 Service elements side pahel ii 14 9 Models parameters and adjustments to preset values 15 10 Indications Contra indica
12. ram number figure 4 18 Fan Symbol 18 1 Fan speed 19 Time Symbol 19 1 Therapy time Zimmer 1 Cryo in brief What is the CryoMini CryoMini may be used for skin cooling in conjunction with dermatological laser treatments to reduce pain and thermal damage to skin tissue What does the CryoMini do The unit blows very low temperature air at adjustable fan settings onto the desired treatment area What is the CryoMini s main advantage Its ease of use makes the CryoMini very simple to operate while the level of performance it delivers in continuous operation is normally found only in much larger devices What other advantages does the CryoMini have Cost effectiveness CryoMini cools through the medium of air so is always ready for use without need for supplies and incurs no running costs The clear LCD display and ergonomically designed key pad represent the latest technological developments How does CryoMini achieve the necessary concentration of cooling Air flow can be varied in 9 steps according to the size and accessibility of the area to be treated level 1 200 litres min level 9 1300 litres min Note unit must only be operated by medical practitioners e g doctors and nursing staff Caution RX only Federal law restricts this device to sale by or on the order of a physician Zimmer The Minimal Load With Load we mean the time the device needs to produce a certain quantity of cold that wi
13. ryo globulinemia Cold agglutinin disease v VIVI 10 3 Treatment Information Prior to the therapy the patient has to be instructed about the effects of the use of the CryoMini skin cooling system If the patient is feeling increasing discomfort or a sensation of excessive heat or cold he has to inform the appropriate clinical staff The airflow level and the distance between the treatment tube s handpiece and the treated area should be selected to maximize patient s comfort During the treatment the patient has to be asked about his sensations If necessary the treatment parameters airflow and therapy distance should be modified For temporary topical anesthetic relief for injections the treated area should be cooled to a comfortable level for the patient Prior to the injection the treated area must be disinfected to avoid contamination Zimmer Pee PEPE Bd Warnings gt gt The device may only be used by trained medical personal Following transport or storage on its side the unit must be placed upright and left for at least 30 minutes before being switched on Failure to observe this may result in damage to the cooling system Do not place the unit in direct contact with sources of heat radiators mud preparations saunas etc Ensure a distance of at least 20 inches 50cm between the unit and the wall to allow air inflow Unfavorable ambient conditions e g ambient temperature above 86 F 30 C and high humidit
14. stic signal Zimmer 4 Adjustments settings and menus 1 Switch unit on Switch on at power switch 9 rear of unit 2 Self test On switch on CryoMini performs a self test routine 3 Making changes to system menu During the self test and the pre treatment cooling period the system menu may be accessed and changes made e g settings may be changed a desired program selected or a custom program defined o Pre cooling 0 Of figure 7 To enter the menu selection mode press the button beneath the menu field 11 Own Programs Favorite Info Automatic Service Program S01 OK Automatic Service Program S02 Start Stop o figure 8 Use the keys marked with arrows 13 14 to navigate through the 11 menu items available The individual menu items are described in detail below Own programs Favorite Info Automatic Service Program S01 Automatic Service Program S02 Device Configuration same Default Settings same Service same Defrosting same Back to Treatment same Use the selection key 11 to choose the required submenu Zimmer 4 1 The menu options in detail 4 1 1 Info Displays system technical data No adjustments can be made in this option 4 1 2 Automatic Service Program S01 Only for use at request of a technician 4 1 3 Automatic Service Program S02 Only for use at request of a technician 4
15. tions for use in conjunction with laser 16 Wi Ie eue NT m 16 10 2 ameta ehm EM Etant tM EUM MEME 16 DU RU CEN DIDI UD IDEM UN CDU UM xDD DENIED DM MM M 16 11 VC S eara an EEE E EE 17 12 Technical data nna 18 13 Cleaning of exterior and disinfection of unit nnn tnter 19 14 Avice USE nr DIDI SQUPN S 19 15 URC CC 6 E E E a a ee eee 20 16 are IMG UAEG accesso Seca 21 17 odlety and Maintenant E 21 17 1 Functional self test 21 18 UC ee 22 19 DISPOSAL iii 22 zimmer Schematic Overview Front side figure 1 Legend Castor Castor guards Control Panel Stand Off Treatment hose nozzle connector Treatment hose Oo DB WN Zimmer Backside and left Side 20 figure 2 figure 3 Legend Zimmer T Condensate collector 8 Air filter 9 Main switch 10 Power inlet 20 Label Control panel controls and display 18 1 19 1 e s OK Start Stop figure 4 14 13 12 11 Key function 11 Increasing of Therapy time 12 Decreasing of Therapy time 13 Increasing of fan speed level figure 4 14 Decreasing of fan speed level figure 4 15 OK 16 otart Stop 17 Display of prog
16. usting the time downwards to the correct value Zimmer 8 Maintenance of unit 8 1 Service elements rear panel gt 9 On off switch gt 8 Air filter gt Power safety cutout The main power switch is located to the rear of the unit On switch on CryoMini performs a self test routine The unit features an air filter 8 to remove coarse dust particles from the air used for cooling and treatment In normal use it is sufficient to clean the filter which is located to the rear of the unit by drawing a vacuum cleaner nozzle across its outer surface This should be carried out at least every 150 hours of use when the software issues a corresponding signal If the unit is operated in rooms with carpets or in other environments with a high level of dust it is recommended that the filter be cleaned more frequently Note After cleaning the filter the signal issued by the software must be reset by pressing the appropriate button CryoMini is fitted with a 2 pole overload circuit breaker to protect the unit from power supply irregularities The circuit breaker is integrated into the on off switch 9 If the circuit breaker triggers the unit must be switched off before it can be reset 0 2 Service elements side panel gt 7 Condensate collector If CryoMini is switched off after use or if the defrosting program is activated the cooling system warms up and creates condensation The unit contains a condensat
17. y may lead to a reduction in performance reduced cooling capacity Magnetic and electric fields may affect the operation of the unit Do not use CryoMini close to equipment that generates strong electromagnetic fields e g X ray or diathermy equipment or nuclear magnetic resonance tomography devices Dispose of packaging material properly Keep such material out of reach of children CryoMini is not designed for use in environments with an explosive or inflammable atmosphere To avoid contamination with non filtered air on open wounds the CryoMini must not be used during or after injection To avoid freezer burns and over cooling the air stream should be directed evenly over the entire area to be treated Static cooling or overly intensive cooling should be avoided Do not increase laser output power or energy when using CryoMini for skin cooling okin cooling may reduce effectiveness of some laser treatment on identical power output of the laser Zimmer 12 Technical data Electrical rating Supply voltage Current consumption Supply protection in unit Protection level Application class MedGV group class General Temperature for storage transport Pressure for storage transport Ambient operating temperature Operation Pressure Internal specifications Low voltage systems within unit Evaporator temperatures Treatment data Airflow rates Maximum treatment time setting Physical dat
18. zimmer Medizinsysteme Zimmer Medizinsysteme GmbH Tel 49 0 731 9761 0 Junkersstrasse 9 Fax 49 0 731 9761 118 Manual CryoMini Read Prior to Handling Transporting or Operating CryoMini CAUTION e Before handling transporting or operating CryoMini check the defrosted water container to make sure that it is empty Once the container is empty CryoMini can be turned onto its side i e for transporting or for changing the castors on the base without resulting water damage e After transporting CryoMini especially when turned onto its side Wait at least 30 minutes before switching on the unit Check the defrosted water container for correct placement at the side of the CryoMini e Installation of the CryoMini Do not place the CryoMini near a heating device heating system fango unit sauna etc Insure a minimum of 50 cm free space behind CryoMini for air circulation Zimmer A CryoMini Note Explanation of Symbols In this manual this symbol indicates danger to patient user or third person In this manual this symbol warns against possible harm to the unit Device type B Protection level against electric shock These instructions form a part of the apparatus and must be kept with it at all times Full observation of these instructions is a requirement for the correct application and operation of the equipment and for the consequent safety of both patient and operator Foll
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