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Zimmer Cryo 7 Instructions For Use Manual Download Page 31

 

 

Safety / Maintenance / Service 

 

12.1 Safety 

12

 

 

 

 

Page 21   

 

 

Safety and 
maintenance 

Cryo 7 was developed and manufactured in compliance with the safety 
regulations of IEC 60601-1. 
Zimmer MedizinSysteme GmbH is responsible for the safety and reliability of 
the device only if 
 

1.

 

the device is operated using a proper power outlet with a protective 
contact and the electrical installation complies with DIN VDE 0100 part 
710. 
 

2.

 

the device is operated in accordance with the instructions. 

 

3.

 

expansions, readjustments or modifications are carried out only by 
persons authorised by Zimmer MedizinSysteme. 

 

4.

 

the user was instructed prior to use in the functional safety, the proper 
operating condition, and the mechanical integrity of the device and 
accessories. 

 

5.

 

the device is operated only by properly trained personnel. 

 

6.

 

the device is not operated in areas at risk of explosion and/or in a 
flammable atmosphere. 

 

7.

 

the device is immediately disconnected from the mains if liquid 
penetrates it. 

 

8.

 

the device does not contain any parts that can be serviced or repaired 
by the operator. This does not apply to the defrost container (emptying 
and cleaning) as well as to the replacement of the air filter. If the air 
filter needs to be changed, this is indicated in the status bar. 

 

9.

 

Replacement of the lithium battery by untrained personnel can lead to 
hazards. 

 

 

Reporting 

All  serious  incidents  associated  with  the  product  are  to  be  reported  to  the 
manufacturer and the competent authority of the state in which the user and/or 
the patient is located. 

 

 

 

 

 

 

 

 

 

 

Summary of Contents for Cryo 7

Page 1: ...Instructions for Use Cryo 7 EN ...

Page 2: ... 7 2 Display 3 Shelf plate 4 Ventilation slits 5 Maintenance door of the defrost container Fig 2 Detailed description defrost container 6 Button to open the maintenance door of the defrost container 7 Maintenance door of defrost container opened 8 Defrost container 3 1 2 4 6 7 8 5 ...

Page 3: ... 10 Connection port for USB 11 Handle 12 Air filter 13 Ventilation slits 14 Base 15 Castors with locking device 16 Locking lever 17 Connection for power cable 18 Mains switch 19 Air outlet with magnetic connection and treatment tube connection 20 Connection port for spring arm 18 17 19 20 16 9 10 12 14 15 13 11 ...

Page 4: ...tic connection and treatment tube connection Connection port for spring arm Locking lever The angle of the lever can be adjusted by pulling the locking lever and simultaneously twisting the device connection Releasing and subsequently juggling the device connection allows the lever to click into the next possible position and the device connection is once again locked in place 21 22 23 ...

Page 5: ...Figures Accessories Fig 5 Accessories 24 Cryo 7 Therapy Hose 2 5m 25 Cryo 7 Therapy Hose Spring Arm 26 Cryo 7 Air Filter ...

Page 6: ...s to the general information area Status bar B Switches to the Memory area to save Favourites Function description C Switches to the Configuration area D Starts the defrosting process E Status of the UV module if this is available F Indication of dirt on air filter only active in the case of dirt on the filter or if a filter change is needed in this case Change needed icon G Switches to the Favour...

Page 7: ...Medical device 3 This symbol indicates Danger with regard to possible risks to people 4 This symbol indicates Caution with regard to possible material damage 5 Follow instructions for use 6 Instructions for use 7 Serial number 8 Article number 9 Manufacturer 10 Date of manufacture 11 RS232 interface 12 USB interface 13 Do not push 14 Maximum load of the shelf plate 35 kg 15 Off power supply ...

Page 8: ...chargeable batteries Products which are marked with the adjacent symbol may not be discarded with household waste 18 Do not stack 19 Protect from moisture 20 Transport upright 21 Fragile 22 Temperature limits 23 Moisture limits 24 Air pressure limits 25 The UDI Unique Device Identifier is assigned for unique device identification and traceability ...

Page 9: ...ations Contraindications 1 2 Side effects Residual risks 1 2 2 Application information and warnings 3 3 Cryo 7 performance features 6 4 System set up 7 5 Software 10 6 Operation instructions 6 1 Configuration 6 2 Performing the treatment 6 3 Displays and buttons start screen 11 13 14 7 Technical information 16 8 Cleaning Disinfection 17 9 CE mark 18 10 Scope of delivery and accessories 19 11 Devic...

Page 10: ... The instructions for use are valid as of December 2021 If the instructions for use have become illegible damaged or are not accessible for the user for other reasons a replacement is to be requested from the manufacturer for the safe use of Cryo 7 and made available to the user This also includes the information on the labels on the device The instructions for use can also be downloaded from our ...

Page 11: ...ons Spasticity and pain in connection with neurological disorders Contraindications Systematic lupus erythematosus Vasculitis Cryoglobulinaemia Cold hypersensitivity Allergies or urticaria Cold induced bronchospasm Raynaud s disease Acrocynosis Sickle cell anaemia Skin circulation disorders Areas with sensory disturbances Paroxysmal cold haemoglobinuria Heart arrhythmia Symptomatic cardiovascular ...

Page 12: ...otential patient group The patients must be able to perceive pain and communicate Patients who have at least one of the contraindications listed may not be treated Weight No limitations User Cold air therapy devices are intended exclusively for medical professionals such as authorised physicians therapists and medical paraprofessionals Cold air therapy devices are not intended for use by layperson...

Page 13: ...amically over the area to be treated Do not use the air outlet in direct contact with patient skin The patient must not be left unattended during the therapy The user must take note of the patient s feedback and react accordingly The user must ventilate the treatment room at the beginning and at the end of a working day We recommend blowing out the therapy hose 3 minutes before the treatment at fa...

Page 14: ...threshold backwards by lifting it at the handle After transport or storage on its side Cryo 7 must be brought to an upright position and kept in an upright position for at least 30 minutes before it is switched on Otherwise the compressor will be damaged Before use ensure that Cryo 7 is supplied with power via a properly grounded power outlet electrical installation according to DIN VDE 0100 part ...

Page 15: ...tre of the shelf plate Observe the maximum load Do not place any liquids on the shelf plate Pushing Cryo 7 at the sides labelled with corresponding warnings is not permitted Do not lean on the device The treatment room should be ventilated in the morning and evening Only USB sticks may be inserted in the USB port It is prohibited to draw operating voltage for small devices or connect devices with ...

Page 16: ...ution display with touch operation All keys menus and sub menus as well as buttons can be activated directly on the touch screen with finger pressure Modern swipe and drag function on the touch screen to select your user preferences with regard to fan level and therapy time The new flexible spring arm assists and supports the user during therapy Energy saving mode through standby operation ...

Page 17: ...the lid of the box into a ramp You can roll Cryo 7 off the pallet using the ramp Converting the lid into a ramp Follow the conversion instructions enclosed with the box or follow the conversion instructions in our YouTube video To do this scan the QR code on the side of the lid of the Cryo 7 box using your smartphone Remove the accessories box at the rear of Cryo 7 Remove the white plastic protect...

Page 18: ...tube in the guide of the spring arm Dismantling the treatment tube Remove the treatment tube from the guide of the spring arm Remove the spring arm from the air outlet Hold the treatment tube on the device end at the plastic sleeve Tilt the tube towards the left or right by pressing firmly with your thumbs and pull it out at an oblique angle Due to the strength of the magnets a certain amount of r...

Page 19: ... button and enter the information using the keypad Activating the Continue button leads to the next screen page and activating the Back button leads to the previous screen page The Continue button jumps to the next screen page Swiping left or right on the screen is also possible and leads to the previous or next screen page The data in the initial set up are accepted by activating the Save button ...

Page 20: ...ll devices or connect devices with an external power supply The version number of the software can be found in the service screen for users in software versions Cryo 7 has 2 interfaces an RS232 interface for possible device communication and a USB interface The USB interface is used for writing log files or for possible updates to Cryo 7 The RS232 interface may be used only by technical personnel ...

Page 21: ...f treatment 5 Treatment time at start of treatment 30 min Screen colour scheme Dark Brightness 6 Volume of the button sounds 7 Standby operation 2 6 hours Temperature unit Degrees Celsius Language English Adjusting the fan levels The fan levels are adjusted using the arrow buttons or by scrolling directly in the bar graph Adjusting the treatment time The treatment time is adjusted using the arrow ...

Page 22: ...rts by touching anywhere on the touch screen If the cooling phase is completed Cryo 7 automatically switches to the therapy screen Note Cryo 7 is not switched off during standby operation Temperature unit The temperature unit is set directly in the desired button Language Activating the Language button opens a selection window with different languages The language is selected directly in the line ...

Page 23: ...ld inform the operator at once Starting therapy Select the fan level and therapy time The therapy starts upon activation of the Start button The screen display changes during the cold air output During the therapy The operator should continue to inquire into patient s comfort during the treatment and the treatment parameters air flow and therapy distance should be modified accordingly Cold air out...

Page 24: ... the individual settings in the configuration menu 3 Display Visual display of the fan level and time set Through direct selection in the display held down for approx 1 second the fan level or time value jumps to the desired location Hold down the value in the display and swipe up or down to change the values for time and fan level as desired These functions are only available on the start screen ...

Page 25: ...isplay switches to the start screen with the Favourites parameters you stored 2 edited moved in the sequence and deleted Activating the Edit button opens the editing mode 2 1 Delete entry Activating the Wastebasket button deletes the entry 2 2 Changing the order of entries By selecting and pressing the double bar the entry can be moved to a different place 2 3 Change entry Activating the Pen butto...

Page 26: ...y 20 80 relative air humidity without condensation Air pressure 900 1030 hPa Environmental conditions for storage and transport Temperature 10 to 50 C Air humidity 10 90 relative air humidity without condensation Air pressure 700 1060 hPa Interfaces USB 2 0 RS232 Temperature emitted at the device outlet 30 C 3 C Fan levels 1 9 Therapy time 1 00 100 00 min Load capacity of the shelf plate Maximum 3...

Page 27: ...disinfection at least once weekly and if there are any signs of contamination Contact your hygiene specialist if necessary Always perform cleaning prior to disinfection Housing cables and accessories can be disinfected using disinfectant wipes Use a commercially available alcohol free disinfectant for metal and plastic with bactericidal virucidal and fungicidal properties Observe the manufacturer ...

Page 28: ...e EC directive on medical devices 93 42 EEC and meets the essential requirements of appendix I of this directive The device is classified in class IIa according to appendix IX of the directive Manufacturer Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany ...

Page 29: ...le 3m 1 10105078 Instructions for use 4 80400752 Device castors Optional items Item no Number Description 93252205 1 Cryo 7 Adjustable Therapy Hose Arm Individual power cable available Please get in touch with your contact partner Subject to changes Note The device may be operated only with original parts from Zimmer MedizinSysteme GmbH Otherwise the function and safety of the patient user and thi...

Page 30: ...device which meets IEC 60601 1 Ed 3 1 In the case of a combination observe the instructions for use of the combined device If Cryo 7 is connected to an IT network for example to an aesthetic medical laser previously unidentified risks to patients operators or third parties may arise The organisation should identify analyse evaluate and monitor these risks Subsequent changes to the IT network could...

Page 31: ...r operating condition and the mechanical integrity of the device and accessories 5 the device is operated only by properly trained personnel 6 the device is not operated in areas at risk of explosion and or in a flammable atmosphere 7 the device is immediately disconnected from the mains if liquid penetrates it 8 the device does not contain any parts that can be serviced or repaired by the operato...

Page 32: ... Empty defrost container icon Maximum capacity reached Cryo 7 also displays a message in the therapy screen to empty the defrost container Emptying To remove the defrost container open the maintenance door Remove the defrost container from the hatch and take the cover off the top of the defrost container After you have emptied the defrost container ensure that the cover is positioned correctly on ...

Page 33: ... summary of the data at the end of Run S01 Caution Run S01 lasts about 90 minutes Afterwards Cryo 7 restarts Performing S02 Activating the Start button under the Run S02 display field starts the Run S02 maintenance program Description of Run S02 The device simulates a 15 minute therapy session Run S02 is repeated until the start stop button is pressed Run S02 is a stress test for the cooling syste...

Page 34: ...ards and remove the air filter from the frame Insert the new air filter with the air filter frame first at the lower retaining support Press the air filter frame into the housing until it clicks into place The two arrows at the upper edge of the air filter must be pointing towards the device The retaining lugs on the air filter frame must click into place on the side of the housing After the air f...

Page 35: ... data can be saved on a USB stick Insert the USB stick in the port provided on the back of Cryo 7 10 Activating the Export log button transfers the data text file to the USB stick This text file supports the error analysis The USB stick must be empty and formatted with FAT32 Troubleshooting Service May only be performed by trained staff ...

Page 36: ... technology as described below Switch on the device Wait until the device is ready for use This is the case when the device switches to the start screen Start Cryo 7 using the start button Select the various fan levels one after the other and check the strength of the air stream and the cold air output ...

Page 37: ... not listed in annex 2 of the MPBetreibV German Medical Devices Operation Ordinance In Germany the German Social Accident Insurance DGUV Regulation 3 Electrical systems and equipment as amended must also be observed Note These requirements apply to the operation of the device in Germany Other regulations may apply in your country ...

Page 38: ... for Configuration then Service and finally Defrost Cryo 7 restarts after defrosting Error report Instructions If an error is detected this is shown via an error message in the display Switch the device off and back on If the error occurs repeatedly contact customer service If instructions are provided e g change air filter empty water container follow the instructions on the screen and restart Cr...

Page 39: ...Web www zimmer de Outside Germany Austria Contact your responsible distributor on site Return shipment Disposal in Germany The device may only be returned in the original packaging Cryo 7 may be disposed of only by the manufacturer Disposal outside of Germany Please refer to national regulations for disposal Contact your distributor if necessary Cryo 7 must not be disposed of in household waste un...

Page 40: ... not specified or provided by the manufacturer of this device can lead to increased electromagnetic interference emissions or decreased electromagnetic immunity of this device resulting in improper operation Cryo 7 device does not contain any exchangeable components cables or other parts which lead to worsening of the EMC WARNING Portable HF communication devices including peripheral devices such ...

Page 41: ...d to be used in the electromagnetic environment as indicated below The customer or user of the Cryo 7 device must ensure that it is used in such an environment Immunity tests IEC 60601 test level Compliance level Electromagnetic environment Guidelines Electrostatic discharge ESD according to IEC 61000 4 2 8 kV contact discharge 2 kV 4 kV 8 kV 15 kV air discharge 8 kV contact discharge 2 kV 4 kV 8 ...

Page 42: ...rom an uninterruptible power supply or a battery Voltage interruptions according to IEC 61000 4 11 0 UT 250 300 cycles 0 UT 250 300 cycles Magnetic field at power supply frequency 50 60 Hz according to IEC 61000 4 8 30 A m 50 Hz or 60 Hz 30 A m 50 Hz Magnetic fields at mains frequency should correspond to the typical values found in business or hospital environments Note UT is the a c supply volta...

Page 43: ...IEC 60601 test level Compliance level Electromagnetic environment Guidelines Conducted disturbances by HF fields according to IEC 61000 4 6 3 V 0 15 MHz 80 MHz 6 V in ISM band between 0 15 MHz and 80 MHz 80 AM at 1 kHz 3 V 0 15 MHz 80 MHz 6 V in ISM band between 0 15 MHz and 80 MHz 80 AM at 1 kHz In the environment of devices which bear the following symbol interferences are possible Radiated elec...

Page 44: ...z deviation 1 kHz sinus 2 0 3 28 710 704 787 LTE band 13 17 Pulse modulation 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE band 7 Pulse modulation ...

Page 45: ...uctions for Use EN 10 105 078 I 1221 I Version 2 I Modifications reserved Zimmer MedizinSysteme GmbH Junkersstraße 9 89231 Neu Ulm Germany Tel 49 7 31 97 61 291 Fax 49 7 31 97 61 299 export zimmer de www zimmer de ...

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