Cryo 6 Manual
Contents
1. Oe OS 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 Cryo Device Type not displayed in above picture because of rotation menu Device Configuration same Default Settings same Service same Defrosting same Back to Treatment same Use the selection key 11 to choose the required submenu 4 1 The menu options in detail 4 1 1 Own programs Only available if program start is set The Cryo 6 can save up to three user defined treatment programs in addition to the 6 programs provided by the manufacturer to which changes cannot be permanently saved The programs can be programmed either for 1 phase or 2 phases following each other O S1 ot 4 CD 05 00 O S2 An 4 05 00 S3 ot 4 05 00 OK Start Stop gy T Back Select figure 9 Programming of 1 phase program Use the arrow keys 13 14 to navigate through the memory locations S1 S2 and S3 Use the select key 11 to enter the desired program S1 amp 7 005 000 00 00 Start Stop gy T figure 10 OK Entering the menu S1 indicates the program parameters program number airflow setting and treatment time The parameters of the 2 4 phase are displayed in small font jus2. ccccccssssssssssessssssesssssscssssesssesscsssesecsesassssesacsesesacsesassssesacsesasecsesacsusesausesassueesansesesansess 21 15 UE Classinca ON nr ti ne te ene nr eee ee ee ee eee ee 21 16 Parts included accessories nn een 22 17 SEEN and EEE e P N AT A ee een A T 22 17 1 Feni SEI E a E E E E EE 22 18 Be MUU SN MA e see ee 23 19 DDOS ee ee ee ee ee eee ee 23 zimmer Schematic Overview Front side 4 figure 1 Legend Castor Castor guards Control Panel Table surface Treatment hose nozzle connector Treatment hose Condensate collector NOOO FP WD Zimmer Backside RR YY RR RR VOOOV R CON A figure 2 m Legend 8 Air filter 9 Main switch 10 Power inlet 20 Label Control panel controls and display 17 18 18 1 19 19 1 M P247 01000 T OK Start Stop PE Pf J T forfan N EN 8 ee 8 Sad az figure 3 14 13 12 11 18 1 19 1 e o OK Start Stop 18 19 figure 4 14 13 12 11 Key function 11 Increasing of Therapy time 12 Decreasing of Therapy time 13 Increasing of program number figure 3 or fan speed level figure 4 14 Decreasing of program number figure 3 or fan speed level figure 4 15 OK 16 Start Stop 17 Display of program number figure 4 18 Fan Symbol 18 1 Fan speed 19 Time Symbol 19 1 Therapy time 1 Cryo in brief What is the Cryo 6 Cryo 6 may be used for skin cooling in conjunction with der
3. 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 humidity may lead to a reduction in performance reduced cooling capacity Magnetic and electric fields may affect the operation of the unit Do not use Cryo 6 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 Cryo 6 is not designed for use in environments with an explosive or inflammable atmosphere To avoid contamination with non filtered air on open wounds the Cryo 6 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 Cryo6 for skin cooling Skin cooling may reduce effectiveness of some laser treatment on identical power output of the laser 19 12 Technical data Electrical rating Supply voltage Current consumption Supply protection in unit Protection level Application class MedGV group MPG class General Temperature for st
4. on oO OK Start Stop Select Ow figure 12 oe a hl a T To select the Favorite scroll through the programs using the arrow keys 13 14 and make your selection with the Select key 11 This stores your selection and returns you directly to the main menu To return to the main menu without setting a Favorite press the Back key 12 4 1 3 Info Displays system technical data No adjustments can be made in this option 4 1 4 Automatic Service Program S01 Only for use at request of a technician 4 1 5 Automatic Service Program S02 Only for use at request of a technician 4 1 6 Cryo Device Type Selection between the Dermatology Derma and the Physiotherapy Physio preset programs 11 4 1 7 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 O Display Backlight Display Contrast Start Stop OK OC eo figure 13 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 t
5. 1 page 17 and the condensate collector 7 chapter 8 2 page 17 17 1 Functional self test On switch on Cryo 6 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 Press the Start Stop button 16 to start operation 4 Select the various air flow levels and check the air flow rate and cooling achieved 22 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 bu
6. 20 13 Cleaning of exterior and disinfection of unit gt Clean the exterior of Cryo 6 with commercial synthetic cleaner or furniture polish but not alcohol based gt For the glass table surface and the treatment tube alcohol or spirit is recommended gt To disinfect the unit and its attachments use commercial equipment disinfectant in accordance with its manufacturer s instructions gt The condensate collector should be disinfected each time it is emptied using a commercial disinfectant A N 14 Advice on treatment and use gt To treat larger areas the distance from the nozzle to the skin should be increased resulting in longer treatment times for adequate cooling gt Ata distance of 5cm the cooling spot covers app 10cm gt Hygienic gloves should be worn during the treatment gt Before treatment the purpose and effect of cryotherapy using Cryo 6 should be explained to the patient gt 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 gt f necessary adjust the treatment parameters air flow rate distance from treatment area gt For use in conjunction with laser equipment a distance of 2 inches 5cm is recommended for a treatment area of 4 square inches 10cm Larger areas should be treated u
7. 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 adjusting the time downwards to the correct value 15 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 Cryo 6 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 Cryo 6 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 brea
8. ceates 11 4 1 4 Automatic Service Program SU ee iaae aaea Aa 11 4 1 5 Automatic Service Program S02 ccsessssssssssssssessessesssssssssssssescssesscsseessssssssessssesesesaesseesesasasaseuesesasesersess 11 4 1 6 Cryo Device TYO ae 11 4 1 7 VS VIC SO NUMAN energie 12 4 1 8 Bor SINIS a ne ee eee ee ae ee er 13 4 1 9 SE ee 13 421 10 DEINOS ee ee reset 13 4 1 11 Back Io realen 13 9 ORO Ct ee een 14 BD SENOLTEA MEN een 15 Re CCS 11 ee eee ene ee eee ee 15 8 MAMEN O U eee eee eee nee ee eee eee nee eee ee eee ee eee ee eee 16 8 1 Service elements rear PANel cceccsssesssssscsesscsssesscsesececsesecscseessesecscsescessesesassesesaesesaesesesasaesesassusesaesesasseeesatenses 16 02 SeNceelment INO lil Pall el eia N 16 9 Models parameters and adjustments to preset values cccccccscssscsssecsesscsesessecessecsssecsesessesessesessesassesassesaeeesensaseees 17 10 Indications Contra indications for use in conjunction with laser treatment cccccseeceeseescssseetseesseeteeeseeeeen 18 1O 6 622 16 Ren rn eee ree eee ee ee eee eee ee 18 102 Conla g 0 6l ne ee ee a ee ee ee eee a ee 18 103 WSCA IN MG FORM ON nennen 18 11 MV UNUM Si e E E E E 19 12 TECHNICAL AGA r E E see nese seeuaeseaearee ors eoeseaseeeotee 20 13 Cleaning of exterior and disinfection of UNI cc scsecssccsssesscscsssececsesscsssesessesesessesescassesesseseseseesesassesesacsesasseeesassesases 21 14 Advice on treatment and use
9. 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 Cryo globulinemia Cold agglutinin disease VUVVUVVVVY 10 3 Treatment Information Prior to the therapy the patient has to be instructed about the effects of the use of the Cryo 5 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 18 11 Warnings gt i gt l 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
10. ed by pressing the Back key 12 The evaporator is defrosted Defrost mode activated N A OK Start Stop figure 18 4 1 11 Back to Treatment This option exits the menu and returns to the treatment display 13 5 Start of treatment Depending whether Cryo6 is set for direct start or programs the displayed menu for starting the treatment differs Direct start Start Stop figure 19 After pre cooling the Cryo6 is ready for treatment Pressing the Start Stop button starts treatment Programs P2 amp 7 10 00 OK Start Stop Py P T s LJ figure 20 After the pre treatment cooling phase the system displays the program display once the required cooling temperature is reached Set the desired treatment program using the selector buttons 13 14 and the treatment time with buttons 11 12 Press Start Stop 16 to begin the program Airflow 13 14 and time 11 12 may be modified during the treatment Airflow cannot be adjusted before the program begins Start Stop figure 21 14 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
11. he new setting Delay time prior to screen saver O Alternative 0 gt no screen saver O 180 1 300 sec OK Start Stop gy T Back Store figure 14 Standby mode saves unnecessary wear on the display and so prolongs its working life 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 Contrast Value 0 23 Start Stop QO eo figure 15 OK gt Start Sequence Entering this menu offers the possibility selecting whether the Cryo offers the program issues pre setting for physical therapy or in direct start mode displays just fan speed and therapy time pre setting for dermatology 12 4 1 8 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 Reset default configuration gt Pa ae Su A OK Start Stop Yes No vo Fn yo F WEN Kd A figure 16 4 1 9 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 a a eg 7 OK Start Stop 5 N Ne wi va figure 17 4 1 10 Defrosting Defrosting begins immediately the Defrost program is selected It can be cancell
12. ker triggers the unit must be switched off before it can be reset 8 2 Service elements front panel 7 Condensate collector If Cryo 6 is switched off after use or if the defrosting program is activated the cooling system warms up and creates condensation The unit contains a condensate 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 Cryo 6 should not be operated with the collector removed 16 9 Models parameters and adjustments to preset values gt 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 Cryo 6 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 The treatment fan can be adjusted through nine levels 2 Treatment time Treatment time may be adjusted between 00 00 and 99 59 minutes 17 N 10 Indications Contra indications for use in conjunction with laser treatment 10 1 Indications The Cryo 6 Cold Air Device is intended to minimize pain and thermal injury
13. lk waste Manufacturer Zimmer Medizinsysteme GmbH Junkersstrasse 9 D 89231 Neu Ulm Tel 49 0 731 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 23
14. matological laser treatments to reduce pain and thermal damage to skin tissue What does the Cryo 6 do The unit blows very low temperature air at adjustable fan settings onto the desired treatment area What is the Cryo 6 s main advantage Its ease of use makes the Cryo 6 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 Cryo 6 have Cost effectiveness Cryo 6 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 Cryo 6 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 1 300 litres min level 9 1000 litres min N Note The unit must only be operated by medical practitioners e g doctors and nursing staff N Caution Federal law restricts this device to sale by or on the order of a physician The Minimal Load With Load we mean the time the device needs to produce a certain quantity of cold that will be stored as a reserve The Minimal Load of the Cryo 6 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 alwa
15. orage 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 data Physical dimensions External dimensions Castors with diameter Maximum load to be placed on the table surface 100 V 120 V7 50HzZ 60Hz SN 734000 738999 standby 2A maximum 9 12A 16A circuit breaker in power on off switch Type B in accordance with IEC 601 1 3 lla 14 F 150 F max 10 C 70 C max 600 1200hPa 32 F 86 F max 0 C 35 C max 700 1200hPa 12V Protection Multifuse 500mA 12V Protection Multifuse 50mA minimum standby 36 F 38 C maximum standby 13 F 25 C maximum operating 1 F 22 C Air temperature at nozzle ambient temperature 77 F 25 C or less average 13 F 25 C at start of treatment 24 F 31 C maximum 1 F 18 C after 15 min treatment Level 1 100 I min Level 2 400 I min Level 3 500 l min Level 4 600 I min Level 5 700 I min Level 6 800 l min Level 7 900 I min Level 8 950 l min Level 9 1 000 I min 99 59 minutes Weight 150lbs 60kg 645x390x680mm HxWxL 7omm lass plate Equipment e g lasers with a maximum weight of 75lbs 35kg and maximum dimensions 20x20x14inches 50x50x35cm WxDxH may be placed on the surface
16. sing a correspondingly larger distance In such cases a longer treatment time is necessary to achieve the required cooling 15 UL Classification The device bears the following UL Mark SSIF a Q C US CLASSIFIED BY UNDERWRITERS 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 21 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 75 mm 17 Safety and Maintenance Cryo 6 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 thatthe 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 thatthe 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
17. st 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 Cryo6 5 figure 1 e Step2 Angle adaptor Attach the accessory storage box through the felt on the top of the unit If included e Step 3 Mounting of the glass plate Mount the glass plate on the top of the device Glass Plate ho Clamp Bearing ro Silicon Washer Standoff 3 Operating instructions Depending whether Cryo6 is set for direct start or programs the displayed menu after the pre cooling phase differs refer to chapter 4 1 7 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 The therapy screens depends whether direct start or programs is set in the device configuration menu Direct start You can directly select the desired fan speed and therapy time Pressing the Start S
18. t underneath the corresponding parameters of the first phase The fan symbol 18 will first blink Use the arrow keys 13 14 to modify the airflow rate 9 steps are available Pressing the Store key 11 will save the airflow rate and enter the time setting the time symbol 19 will blink The time may be set from 0 to 99 59 minutes 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 Pressing the Store key will save the therapy time and enter automatically the 2 phase The parameters of the first phase are displayed in small font above the 2 phase If you want to store a 1 phase program simply press the Back key in order to exit the program Programming of 2 phase program Follow the steps described above Instead of leaving the 2 phase by pressing the Back key save an airflow level and treatment time as described above for the 1 phase 10 The picture below shows all Own Programs together with their currently set parameters O S1 An 4 SB os O S2 ot 4 05 00 S3 ha 4 05 00 OK Start Stop gy T Back Select figure 11 4 1 2 Favorite Only available if program start is set The user may select a favorite program from either the six preset programs P1 P6 or the three Own Programs S1 S3 The selected program is loaded automatically when the unit is switched
19. top button starts the therapy Start Stop figure 5 Programs This software option offers the opportunity for running the Cryo with different pre set therapy parameters Even the use of interval programs is available Set the desired treatment program using selector keys 13 14 and the treatment time with keys 11 12 Press Start Stop 16 to begin the program Airflow 13 14 and treatment time 11 12 may be altered during the treatment en o wr P2 amp O 10 0 2 OK Start Stop PE Pf T A e N gt ey wau figure 6 3 End of treatment 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 acoustic signal 4 Adjustments settings and menus 1 Switch unit on Switch on at power switch 9 rear of unit 2 Self test On switch on Cryo 6 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 IN O Pre cooling EIS Ne _ co OK cr fe Ce o gt ee Oe 87 BU 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
20. ys 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 either the program number figure 6 or the direct Start display figure 5 is shown by the device 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 automatically The frequency required to maintain an adequate cold reserve will vary according to the surrounding climatic conditions Important Advice for Optimal Use The fir
21. zimmer MedizinSysteme 80 80 0 YSN 091d Cryo Version 6 User Manual Zimmer MedizinSysteme GmbH Junkersstra e 9 D 89231 Neu Ulm Tel 49 731 9761 291 Fax 49 731 9761 299 www zimmer de Zimmer MedizinSysteme Explanation of Symbols N 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 Cryo 6 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 Note Following maintenance work or after being transported on its side Cryo 6 must be left in the upright position for a minimum of 30 minutes before being switched on to avoid damage to the compressor Content Eee ee 5 22 PSST WS CN ONG een E E T 3 DIE ae ee ee 8 4 Adjustments settings and MENUS cccsccessessssessssesssscsssecsssecsceesaceesaccessecesseceseesacsesacsesaeseseesaseesaseesaesesatseseesasensasensasentan 9 41 VSAM NOD UON SN COTA siiin E aiidis aeia aiaia adraia 10 4 1 1 Own progianis Only avalanse i progran start isses rei iee 10 4 1 2 Favorite Only available progran Star 18 SOf sedeeccetetet ronisin ennaa a ee ee ee 11 4 1 3 T a E E E nce neeetcateeransecesnessesececaae
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