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Zimmer CryoMini, Instructions For Use Manual

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Zimmer CryoMini Instructions For Use Manual Download Page 31

 

Safety Check 

Metrological Control

 

16

   

 

 

Page 24 

 

 

 

  For the device CryoMini neither a Safety check (STK) nor a Metrological Control 

(MTK) is required in Germany. 

 

In Germany, among others, the Medical Devices Operator Ordinance (MPBetreibV) 

and the BG regulation to electrical systems and equipment (BGV A3) apply in their 

current version. 

   

Note: 

These provisions apply to the operation of the device in Germany. Observe the 

different national regulations of your country, if applicable. 

 

 

 

Summary of Contents for CryoMini

Page 1: ...Instructions for Use CryoMini GB EU ...

Page 2: ...lustrations Front of Device Fig 1 Equipment and Controls 1 Castor 2 Castor guards 3 Control panel 4 Tray 5 Treatment tube connection Fig 2 6 Treatment tube 7 Treatment tube connector socket 1 2 4 5 3 6 7 ...

Page 3: ...Illustrations Rear Left side of Device Fig 3 Fig 4 Equipment and Controls 8 Air filter 9 Identification plate 10 Mains switch 11 Power inlet 12 Condensation water container 8 10 11 9 12 ...

Page 4: ... Increasing treatment time 14 Reducing treatment time 15 Increasing fan speed 16 Reducing fan speed 17 OK button 18 Start Stop key 19 Fan speed icon 20 Fan speed display 21 Symbolic display of treatment time 22 Treatment time 23 Temperature of vaporiser 24 Note Warning 16 15 17 14 13 18 19 20 21 22 23 24 ...

Page 5: ...ns for use this symbol indicates Caution with regard to possible damage of the device Applied part type B Do not push sideways Maximum permissible load on the glass plate 35kg Follow Instructions for Use Operation instruction Serial number Article number Manufacturer Date of manufacture Max 35 kg 77 16 lb ...

Page 6: ...he Physical Therapy 1 2 Indications Contraindications in the Aesthetics 1 2 2 Side Effects 3 3 Application information 4 4 Warnings 6 5 CryoMini in brief 7 6 Device Set Up 8 7 Operation instructions 7 1 Device description 7 2 Performing the treatment 10 11 8 Settings 12 9 Technical Information 17 10 Cleaning Disinfection 18 11 CE mark 19 12 Scope of Delivery and Accessories 20 ...

Page 7: ...ntrol 25 17 Error Messages Troubleshooting Disposal 26 18 Manufacturer s EMC declaration 28 Valid for the CryoMini devices This instructions for use is an integral part of the device It must be stored with the device and kept accessible at all times for anyone authorized to operate this device The instructions for use is valid as of November 2014 ...

Page 8: ...rapy using preceding cooling in combination with compresses for acute injuries for preventing edemas and hematomas in the field of sports medicine for preventative early treatment prior to pain setting in immediately after severe stress e g competitions for treating muscular trigger points in combination with stretching Other indications should be discussed with the treating physician or taken fro...

Page 9: ...ess swelling and scabbing reduction of pain and thermal skin damage Absolute contraindications cryoglobulin anemias cold agglutinin disease and cryohemolysis cold urticaria areas with circulatory disorders Raynaud s syndrome areas with sensitivity disorders trophic disorders hypersensitivity to cold Relative contraindications When treating children body parts not being treated must be covered and ...

Page 10: ...Side Effects 2 Page 3 Side effects Cold related skin damage such as skin irritations up to slight frostbite and chilblains may occur especially in sensitive patients ...

Page 11: ...th the supplied power cord The power cord must be protected against mechanical stress Caution Operation of this equipment in the vicinity of strong electromagnetic fields e g tomographs x ray or diathermy equipment may interfere with the operation of the device Please keep a safe distance of several meters CryoMini is not suitable for operation in explosive flammable or combustive environments Do ...

Page 12: ...ent such as extreme cold sensation must be reported immediately to the operator During therapy the treatment provider should ensure the well being of patients through appropriate questions If necessary the treatment parameters air power level and distance to the treatment area should be adjusted Joints and muscles require prolonged treatment otherwise only the skin surface and upper skin layers wi...

Page 13: ...rectly Make sure that it is not accessible to children The cold air flow may not be applied to open wounds For application of cold in the face the eyes must be protected The air flow should be evenly applied over the treated area Static or too intensive cooling must be avoided as it can lead to frostbite and hypothermia The use of this product with settings or applications other than those specifi...

Page 14: ... CryoMini The clearly structured LCD display and the ergonomic keyboard feature stated the art technology The operation of the device leads to low energy consumption Intended Use The cold air device CryoMini is used for skin cooling in the treatment of injuries or musculoskeletal diseases for local pain relief Note The application of the device is reserved for medical professionals such as physici...

Page 15: ...ll glass plate Put a silicone washer on each of the 4 spacing bolts mounted in the hood Then place the glass plate on the spacing bolts Attach the glass plate by screwing clamp bearings in each of the 4 spacing bolts For this use the supplied U tool Do not lift CryoMini on the glass plate Clamp bearings Glass plate Spacing bolt ...

Page 16: ...Caution After transport or assembly work in a horizontal position CryoMini must stand upright for at least 30 minutes before switching on The compressor may otherwise be damaged Turn the device on The device is switched on using the toggle switch 10 Turn the device off The device is switched off using the toggle switch 10 To disconnect the device completely all pole from the mains unplug the power...

Page 17: ...herapy the therapy fan blows cold air through the treatment hose At the same time the compressor capacitor starts automatically during the treatment to ensure a constant cooling Stand by mode If no therapy is performed CryoMini is in stand by mode In order to ensure that sufficient cool air can be provided at any time the compressor starts automatically as soon as a certain temperature is exceeded...

Page 18: ...begins CryoMini is ready when the start up screen shows The treatment can be started by pressing the Start Stop button Fan level and treatment time can be adjusted optionally 7 05 30 OK Start Stop 10 C End of treatment The end of treatment with automatic fan shutdown is signalled acoustically This also applies to a premature termination of treatment through the Start Stop button Note The patient s...

Page 19: ...e Configuration Select Technical information can be queried and changed in the menu To access the various menu options use the arrow keys The following may be selected Info Automatic Service Programme S01 Automatic Service Programme S02 Device Configuration Default settings Service Back to treatment Defrosting Selection of menu items Info Automatic maintenance programme S01 Automatic maintenance p...

Page 20: ...ng threshold setting Use this submenu to display the warning on the display and to enable disable the acoustic alarm Warning Select CHANGE to change the current setting If ON is selected the alarm will sound for 2 minutes in intervals of one second Press SAVE to save the changed settings OK Start Stop Audio warning STORE BACK CHANGE State ON Setting warning threshold temperature With this menu you...

Page 21: ...e displayed Setting of warning threshold Display Backlight Select Back Language Display Contrast Display contrast Provides setting options for the display contrast with values between 10 and 30 The contrast is very low at 10 and very high at 30 OK Start Stop Setting of Display Contrast Store Back Contrast Value 10 30 18 Basic settings Selection via the YES button Changed parameters are reset the f...

Page 22: ... Stop 10 C The treatment display shows following the pre cooling CryoMini is ready Press Start Stop to start the therapy End of treatment The end of treatment with automatic fan shutdown is signalled acoustically This also applies to a premature termination of treatment through the Start Stop button Treatment time The treatment time can be set from 00 00 to 99 59 minutes Pressing the arrow key wil...

Page 23: ...0 C 70 C 10 to 90 relative air humidity no condensation for 600 1200 hPa Note Storage and Transport only in original packaging Storage and transport only with empty water container Generated vaporiser temperature minimal stand by maximum stand by 37 C 10 C Outlet temperature at the beginning of treatment at least 15 C at ambient temperature of 25 C or less Value accuracy 10 Max adjustable treatmen...

Page 24: ...least once a week as well as in the event of evidence of possible contamination Consult with your health professional when doing so Always perform cleaning prior to disinfection Housing cables and accessories can be disinfected with disinfectant wipes To do so use a commercially available alcohol free disinfectant for metal and plastic which is bactericidal virucidal and fungicidal Observe the app...

Page 25: ...CE mark 11 Page 18 The product bears the CE marking in accordance with the EC directive on Medical Products 93 42 EEC ...

Page 26: ...ns cable 1 Instructions for use see accessories Accessories Art No 95852210 Treatment tube light 65373510 Adaptor without clip 95372620 Adaptor with 20 mm clip 80026510 Defrosted water container 80400754 Castor 75 mm with brake 80401001 Castor 100 mm with brake 65850410 Castor guard 65490610 Tray 67300124 Mains cable 10102142 Instructions for use Subject to modifications ...

Page 27: ...mbinations 13 Page 20 No combination devices are provided by the manufacturer for CryoMini Anyone who contrary to these specifications combines devices and thus operates a medical system does so at its own risk ...

Page 28: ... in accordance with the instructions for use extensions readjustments or modifications are carried out only by persons authorised by Zimmer MedizinSysteme GmbH the user has ascertained the functional safety the proper operating condition and mechanical integrity of CryoMini before use the device is operated only by properly trained personnel the device is not operated in hazardous areas and or a c...

Page 29: ...mstances lead to increased dust generation more frequently cleaning of the filter element is recommended Note After cleaning the air filter the message of the software must be confirmed with OK button Emptying the container for defrosted water If the CryoMini is switched off after use or the defrost program is started the cooling system heats up and generates condensate The one liter container for...

Page 30: ...st of the cooling function can be performed by the user if required as described below 1 Turn the device on 2 Wait until the device is ready for operation This is achieved when the device displays the treatment display 3 Start CryoMini with the Start Stop button 4 Select the various air power levels one by one and check the strength of air flow and the cooling performance ...

Page 31: ...required in Germany In Germany among others the Medical Devices Operator Ordinance MPBetreibV and the BG regulation to electrical systems and equipment BGV A3 apply in their current version Note These provisions apply to the operation of the device in Germany Observe the different national regulations of your country if applicable ...

Page 32: ...o collect the condensate Slowly unscrew the defrost drain Clean the defrost drain under running water and screw it back in Error messages When switching on the device and partly during ongoing operation device components important for the program sequence are tested If an error is determined the treatment will be canceled an error message appears in the top line of the display and an acoustic sign...

Page 33: ...zimmer de Disposal The device may only be returned in original packaging to the factory It must be disposed of by Zimmer MedizinSysteme GmbH In foreign European countries please refer to national regulations for disposal Contact your distributor if required ...

Page 34: ...ni device should assure that it is used in such an environment Interference tests Compliance Electromagnetic environment guideline HF emissions according to CISPR 11 Group 1 CryoMini uses HF energy only for its internal function Its HF emission is therefore very low and it is unlikely that this will cause interference to neighbouring electronic equipment HF emissions according to CISPR 11 Class B ...

Page 35: ...pital environment Surges according to IEC 6100 4 5 1 kV differential mode voltage 2 kV common mode voltage 1 kV differential mode voltage 2 kV common mode voltage Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations of power supply acc to IEC 61000 4 11 5 UT 95 dip in UT for cycle 40 UT 60 dip in UT for 5 cycles ...

Page 36: ...kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Portable and mobile radio communications equipment should not be used closer to CryoMini including its cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2 P d 0 35 P for 80MHz to 800 MHz d 0 7 P for 800 MHz to 2 5 GHz where P is the rated power of the ...

Page 37: ...ended for operation in an electromagnetic environment where HF disturbances are monitored The customer or user of the CryoMini device can contribute to avoiding electromagnetic errors by adhering to the minimum distance between portable and mobile HF telecommunications devices transmitters and the CryoMini device depending on the output power of the communication device as indicated below Rated ou...

Page 38: ...r MedizinSysteme 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 Instructions for Use GB 10 101 667 UR 1114 I Version 2 I Right of modifications reserved ...

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