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EMC Manufacturer’s Declaration 
 
 

 

16. 

 

 

 

 

 

 

 
Medical electrical devices, such as Cryo

Mini

, are subject to special precautionary measures with regard to EMC 

(electromagnetic compatibility) and must be installed and put into service in accordance with the EMC instructions 
contained in the operating instructions or the accompanying papers. 
 
Portable and mobile HF communication devices (e.g. mobile telephones, cellphones) can influence medical electrical 
devices. 
 
Cryo

Mini

 may be operated only with the original parts stated in the list of the scope of supply and accessories. Operation 

of the device with other parts can lead to increased emissions or reduced interference immunity of the device! 

 

Guidance and manufacturer’s declaration – Electromagnetic emissions 

The Cryo

Mini

 device is intended for use in the electromagnetic environment specified below. The customer or the 

user of the Cryo

Mini

 device should assure that it is used in such an environment. 

Emissions test  

Compliance 

Electromagnetic environment - Guidance 

RF emissions to CISPR 11 

Group 1 

The Cryo

Mini

 device uses RF energy only for 

its internal function. Therefore, its RF 

emissions are very low and are not likely to 

cause any interference in nearby electronic 
equipment. 

RF emissions to CISPR 11 

Class B 

The Cryo

Mini

 device is suitable for use in all 

establishments, including domestic 
establishments and those directly connected 

to the public low voltage power supply 

network that supplies buildings used for 

domestic purposes. 

Harmonic emissions to IEC 61000-3-2 

Class A 

Voltage fluctuations / flicker emissions to 

IEC 61000-3-3 

Complies 

 

The device may not be used directly next to other devices or arranged stacked with other devices. If operation is 
required close to other devices or stacked with other devices, the device should be observed to check its operation in 
accordance with the regulations in this used arrangement. 
 

Summary of Contents for CryoMini

Page 1: ...Operating Instructions CryoMini JP GB...

Page 2: ...always to be kept in close vicinity of the device Careful observation to instructions found within the User Manual is the supposition for correct usage and handling of the device as well as for patie...

Page 3: ...ons 10 4 2 Treatment Settings 14 5 Maintenance 15 6 Models Parameters and Adjustments for Preset Values 16 7 Indications Contra indications 17 8 Warnings 18 9 Technical Data 19 10 Cleaning and Disinfe...

Page 4: ...2 Schematic Overview Front View Figure 1 Legend 1 Castor 2 Castor guards 3 Control panel 4 Standoff 5 Treatment tube connector 1 2 4 5 3...

Page 5: ...3 Back and Left Side View Figure 2 Figure 3 Legend 6 Defrosted Water Container 7 Air Filter 8 Mains Switch 9 Mains Inlet 19 Label 7 8 9 19 6...

Page 6: ...Function Keys 10 Increase Treatment Time 11 Decrease Treatment Time 12 Increase Fan Speed Level 13 Decrease Fan Speed Level 14 OK 15 Start Stop 16 Fan Symbol 16 1 Fan Speed 17 Time Symbol 17 1 Treatme...

Page 7: ...iding a level of performance in continuous operation found normally only in much larger devices What other advantages does the CryoMini have CryoMini is economic and cost effective as it filters and c...

Page 8: ...s of cold capacity during treatment and will continue to run until the cold reserve is complete Once complete the compressor and condenser fan stop and CryoMini shifts into a Stand by Mode The Total L...

Page 9: ...each 4 pre assembled standoffs Place the glass plate onto the standoffs Affix the glass plate using the U shaped pin to screw the four grey flat screws through the glass plate and into the standoffs F...

Page 10: ...vice is ready for operation the screen changes from the Pre cooling Mode to the Therapy Mode display The therapy fan speed and treatment time can be adjusted directly by using the Function Keys Pressi...

Page 11: ...e press the Menu button on the display 10 Figure 4 OK Default Settings Automatic Service Program S01 Automatic Service Program S02 Info Start Stop Device Configuration Select Figure 9 Use the Function...

Page 12: ...e If ON is selected the Evaporator temperature will be displayed in therapy Screen 18 Figure 4 The displayed temperature is NOT the AIR temperature OK Start Stop Evaporator temperature displayed STORE...

Page 13: ...ack Temperature 20 20 C 4 Figure 12 Warning text in display Select CHANGE 13 Figure 4 to change the state If ON is selected the warning text will be displayed in the Therapy screen 18 1 Figure 4 Press...

Page 14: ...ave the new setting OK Start Stop Delay time prior to screen saver Store Back Alternative 0 no screen saver 1 300 sec 180 Figure 15 The screen saver promotes display durability Display Contrast Use th...

Page 15: ...Back to Treatment This option exits the menu and returns to the treatment display Defrosting Defrosting begins immediately once the Defrost program is selected It can be cancelled by pressing the Bac...

Page 16: ...nually by pressing the Start Stop key 15 Figure 4 Treatment Time Setting Time ranging from 00 00 and 99 59 minutes may be set Pressing the Up or Down Key once increases or decreases the Treatment Time...

Page 17: ...r be cleaned more frequently Note After cleaning the filter the signal issued by the software is reset by pressing the appropriate button mentioned in the display Power safety shut down CryoMini is fi...

Page 18: ...by selecting the Main Settings function see Adjustments Settings and Menus Chapter 4 Adjustments to preset parameters CryoMini allows the Airflow and Treatment time to be adjusted and saved to meet th...

Page 19: ...rfusion problems areas of impaired circulation Altered skin sensitivity areas of impaired sensation Open wounds Ablative laser treatment Cryoglobulinaemia Cold agglutinin disease Treatment Information...

Page 20: ...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...

Page 21: ...ty Defrosted Water Container Operating Temperature 0 C 35 C Pressure 700 1200 hPa Steady humidity level from 30 to 95 Evaporator temperatures Minimum Standby 20 C Maximum Standby 10 C Treatment Data A...

Page 22: ...alcohol based Alcohol is recommended for the glass plate surface and the treatment tube To disinfect the unit and its attachments use commercially available equipment disinfectant in accordance with i...

Page 23: ...patient to report any adverse reactions during treatment e g extreme cold sensations immediately to the practitioner The practitioner should check the wellbeing of the patient by asking appropriate q...

Page 24: ...n order 95852210 Light treatment tube woven version 65373510 Adapter without clip 95372620 Adapter with 20 mm clip 93852660 Am for light treatment tube 80026510 Defrosted water container 80400751 Cast...

Page 25: ...sonnel acting on behalf of Zimmer MedizinSysteme GmbH The unit contains no user serviceable parts with the exception of the Air Filter 7 chapter 8 1 page 15 and the Defrosted Water Container 6 chapter...

Page 26: ...tch 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 devi...

Page 27: ...25 Disposal 15 The unit must be disposed of through an authorized and accredited company and should under no circumstances be placed in the ordinary or bulk waste...

Page 28: ...The customer or the user of the CryoMini device should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment Guidance RF emissions to CISPR 11 Group 1 Th...

Page 29: ...4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions...

Page 30: ...d in no smaller distance to the CryoMini including the cables than the recommended protective distance that is calculated according to the equation appropriate for the transmission frequency Recommend...

Page 31: ...peration in an electromagnetic environment in which the RF disturbances are controlled The customer or the user of the CryoMini device can help to avoid electromagnetic disturbances in that it complie...

Page 32: ...zinSysteme GmbH Junkersstrasse 9 D 89231 Neu Ulm Tel 49 731 97 61 291 Fax 49 731 97 61 299 export zimmer de www zimmer de Operating Instructions JP GB 100V 10 101 968 UR 0610 I version 1 I Right of mo...

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