IceCure ProSense User Manual Download Page 36

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IceCure Medical Ltd.

DSR3210000 rev. D

ProSense™

Confidential

User Manual

Return to first page

Symbol

Meaning

Fragile, handle with care

Do not use if package is damaged

Cold area

Consult instructions for use

Oxygen depleting

This side up

Authorized representative in the European community

CE mark- mandatory conformity mark for products placed
on the market in the European Economic Area

Transportation and storage atmospheric pressure limits

Summary of Contents for ProSense

Page 1: ...tive IceCure Medical Inc 41 18 Christine Ct Fair Lawn NJ 07410 icecuresupport icecure medical com Tel 1 646 844 3066 Toll free 888 516 7389 IceCure Medical Ltd HaEshel 7 2nd floor Southern Industrial...

Page 2: ...ating warnings 19 2 4 Liquid nitrogen 21 2 4 1 Danger explosion and fire hazard 21 2 4 2 Opening the Dewar compartment 21 2 4 3 Voltage and power ratings 22 2 4 4 Liquid nitrogen Safety 22 2 4 5 Burn...

Page 3: ...4 4 Shipment components 53 4 5 Installation 54 5 OPERATING THE SYSTEM 55 5 1 Procedure Overview 55 5 2 Pre operational stages 55 5 2 1 Preparing the system for procedure 55 5 2 2 Preparing the patien...

Page 4: ...oablation system Step by Step procedure 124 11 SYSTEM SPECIFICATIONS 125 12 LIMITED WARRANTY CERTIFICATE 126 13 CUSTOMER COMPLAINT FORM 127 14 REPORT CUSTOMER COMPLAINT 128 15 Manufacturer s Declarati...

Page 5: ...played on screen several of the options 46 Figure 33 The foot pedal 46 Figure 34 The temperature sensor and its components 47 Figure 35 Temperature display of sensor in the procedure screen see no 1 4...

Page 6: ...stration of FAP7200000 probe Markings on the probe 86 Figure 78 Pause No 1 and Play No 2 buttons during the freeze cycle 88 Figure 79 Manual Mode screen press on Freeze to start the freeze cycle 88 Fi...

Page 7: ...e 107 The Main Menu screen To shut down the system press on the Shutdown icon see no 1 106 Figure 108 The System Shutdown screen Press OK to proceed see no 2 106 Figure 109 System Fail example screen...

Page 8: ...logy thoracic surgery gynecology oncology proctology and urology The ProSense cryoablation system may be used with an ultrasound device to provide real time visualization of the cryosurgical procedure...

Page 9: ...ale genitalia General Surgery The system may be used for the ablation of leukoplakia of mouth angiomas sebaceous hyperplasia basal cell tumors of the eyelid or canthus area ulcerated basal cell tumors...

Page 10: ...he ProSense cryoablation system Practitioners electing to be ProSense cryoablation system users must attend a training course prior to using the system The course is taught by IceCure Medical certifie...

Page 11: ...this equipment without authorization of the manufacturer 1 7 Advanced Operator You are a qualified ProSense cryoablation system Advanced Operator only if you meet all of the following criteria You ha...

Page 12: ...his Caution this notice is called a Caution it deals with danger to equipment and data Caution It is dangerous for equipment and data to do this 2 2 Basic safety principles All the safety issues expla...

Page 13: ...nance or to repair the system 2 2 3 Training Warning Do not use this system if you have not been adequately trained in its use 2 2 4 Clarity Warning Do not use this system until you have read the User...

Page 14: ...ecome cold during the cryoablation procedure Operators should consider insulating these parts in order to prevent discomfort to the patient Warning The supplier and manufacturer of the ProSense cryoab...

Page 15: ...sing Ultrasound or other appropriate imaging systems Caution Artifacts from the devices may appear in the Ultrasound or CT image Warning Temperature sensor and probe insertion and navigation within ti...

Page 16: ...er positioning the main chassis lock the front roller brakes Failure to do so may result in damage to the system or to other equipment in the clinic room Caution The ProSense cryoablation system must...

Page 17: ...pproved and labeled Dewars for your system Caution Dewars should always be stored with their lids in place Caution Only Dewars and lids supplied by IceCure Medical may be used with the ProSense cryoab...

Page 18: ...hard surface or compromised in any manner as internal damage to the cryoprobe may have occurred Caution Do not move the system when the Dewar contains liquid nitrogen Warning Removing the Dewar or pl...

Page 19: ...cryoprobe is screwed onto the cryohandle hang the cryohandle in its cradle to prevent a stabbing injury from the cryoprobe Be sure to maintain sterility of the cryohandle and cryoprobe Warning Before...

Page 20: ...ecking the serial number ON the package and on the cryoprobe itself Entering an incorrect cryoprobe S N registration will result in probe nullification Warning Do not allow any liquid or humidity to e...

Page 21: ...tem 2 4 1 Danger explosion and fire hazard Warning The ProSense cryoablation system includes electronic devices that may emit sparks and therefore should not be operated in the presence of ANY flammab...

Page 22: ...an tell that a Dewar is damaged if after filling it frost appears on the outer wall of the container Return the Dewar to an IceCure Medical technician or an authorized distributor for inspection Warni...

Page 23: ...r venting To assure safe operation only use the original sponge lid supplied with the dewar Liquid nitrogen containers should always be stored in an upright position Tipping the container or letting i...

Page 24: ...an reach very low temperatures Warning Portions of the cryoprobe other than the freeze zone including the plastic cover that is located near the cryoprobe handle may become cold and cause tissue damag...

Page 25: ...iously used single use cryoprobe temperature sensor and sterile sleeve have been removed and discarded Any used cryoprobe and temperature sensor should be designated as used sharp biohazard waste 2 4...

Page 26: ...F the system Call IceCure Medical and describe the error shown on the screen as precisely as possible Do NOT attempt to reuse the system before contacting IceCure Medical Warning When an error message...

Page 27: ...ly may leak into the ground This can contribute to soil and water pollution which is hazardous to human health and endangers wildlife Therefore such equipment must not be disposed of in landfill sites...

Page 28: ...supply Disconnect all plugs Label 6 DANGER Line voltage Label 7 Foot pedal Not available in some regions e g China Label 8 DANGER Risk of explosion if used in the presence of flammable anesthetics CA...

Page 29: ...irst page System Labels Figure 1 Label 1 ON OFF mechanical button MLS1000002 Rev B Figure 2 Label 2 Emergency Stop MLS1000003 Rev B Figure 3 Label 3 Identification MLS3180001 Rev E 220 240 VAC MLS3080...

Page 30: ...idential User Manual 30 Return to first page Figure 5 Label 5 High voltage caution MLS1000006 Rev B Figure 6 Label 6 Line voltage danger MLS1000007 Rev B Figure 7 Label 7 Foot pedal MLS1000008 Rev B F...

Page 31: ...User Manual 31 Return to first page Figure 9 Label 9 Single use probe various options of shapes tip length and sizes MLP7000001 Rev J Figure 10 Label 10 Single use temperature sensor MLT8000001 Rev H...

Page 32: ...Confidential User Manual 32 Return to first page Figure 12 Label 12 Black Dewar MLS1000015 Rev B Figure 13 Label 13 Cold area MLS1000010 Rev B Figure 14 Label 14 Empty LN2 Dewars MLS1000012 Rev A Figu...

Page 33: ...DSR3210000 rev D ProSense Confidential User Manual 33 Return to first page Figure 16 Label 16 Holder MLG1000006 Rev B Figure 17 Label 17 Shipping Art Work MLS3080002 Rev A Figure 18 Label 18 Shipping...

Page 34: ...e use Introducers various options of length and sizes MLC9000002 Rev C 2 10 1 Important Symbols and Labels A number of internationally recognized symbols relating to safety requirements and standards...

Page 35: ...omponents that must be collected and disposed of separately Never dispose of electrical and electronic components in general municipal waste receptacles Electrical and electronic equipment contain haz...

Page 36: ...andle with care Do not use if package is damaged Cold area Consult instructions for use Oxygen depleting This side up Authorized representative in the European community CE mark mandatory conformity m...

Page 37: ...ts Storage temperature limits Keep away from sunlight Keep dry CAUTION US Federal law restricts this device to sale by or on the order of a physician Mandatory conformity mark for electronic products...

Page 38: ...erational details system processes that occur as a result of user actions 3 2 Concept of operation The ProSense cryoablation system is intended for cryogenic destruction of tissue during surgical proc...

Page 39: ...Dewar Holder Not available in some regions e g China foot pedal Not available in some regions e g China and single use cryoprobes Product Name Description Part Number Cryoablation Console 100 127 VAC...

Page 40: ...grip handle for ease of system transportation Figure 22 The ProSense transportation rollers brakes 3 3 2 Emergency Stop button The Emergency Stop button is a red knob located ON the right upper side...

Page 41: ...g procedure 3 3 4 Touch screen and User Manual activation The touch screen is located ON the top of the main chassis and allows for operating and monitoring of the system It is designed for users and...

Page 42: ...Figure 25 The User Manual screen You can choose the part you want to read from the Table of Contents click on it and you will access it directly Figure 26 The User Manual Table of contents You can se...

Page 43: ...IceCure Medical representative If you would like to acquire our paper form User Manual Book please contact us directly and one will be sent to you within 7 working days We can be reached at 888 516 73...

Page 44: ...cryoprobe temperature sensor and sterile sleeve Caution Artifacts from the devices may appear in the Ultrasound or CT image 3 3 5 1 Handle plug holder and handle plug The handle plug holder is locate...

Page 45: ...se in a specific position during the procedure The holder is adjustable in height and length and should be adjusted by the user as required The hose can be safely put on the Holder arm once positionin...

Page 46: ...nical judgment Prior to starting a procedure the temperature sensor is connected to the system and inserted into the desired location within the tissue Insert the sensor at location that gives useful...

Page 47: ...ture sensor from the sterile package 2 Connect the cable connector to the panel connector on the upper right corner of the main chassis while keeping the connector key facing the groove 3 The measured...

Page 48: ...g below Figure 37 Dewar storage cases the correct way to put the Dewars inside the storage shelf Safe transportation When moving the system from one location to another the Dewars must be empty Operat...

Page 49: ...en may cause if there is not sufficient ventilation in the room serious injury or burn if handled improperly Local laws and safety rules regarding the maintenance and handling of liquid nitrogen dewar...

Page 50: ...reen to load Figure 41 The Main Menu screen 3 4 2 System pre tests As the system uploads several internal built in tests are performed automatically in order to verify that the system is safe for use...

Page 51: ...tomatic mode pre programmed and monitored by the computer During the entire procedure the system continues its internal check In case of system error the user will be instructed as to the appropriate...

Page 52: ...e if there is not sufficient ventilation in the room serious injury or burn if handled improperly Local laws and safety rules regarding the maintenance and handling of liquid nitrogen Dewars should al...

Page 53: ...al line voltage as specified by the user Accordingly the unit will require a line supply of 220 240 VAC 50 60 Hz 7A single phase The unit is grounded through the power cable that is plugged into the w...

Page 54: ...loves Mid arm length large waterproof pair Face shield up to LN2 protection 4 5 Installation Warning The ProSense cryoablation system must be unpacked installed and tested by an IceCure Medical author...

Page 55: ...al applications performed without the use of imaging device For these applications the practitioner should follow standard clinical procedures that are not within the scope of this user manual TRAININ...

Page 56: ...maging device in all dimensions prior to procedure to determine long axis and point of entry 4 See Figure below for a schematic illustration of the placement of the system and the patient in the treat...

Page 57: ...cryotherapy no external imaging device is required The mechanical power switch is OFF The cryohandle hose and cradle are all clean and dry To Switch on the ProSense cryoablation system To switch the s...

Page 58: ...Figure 45 The Action button as displayed on screen several of the options Light status indicator This is a BLUE LED which lights up around the Action button indicating the activity of a freeze cycle R...

Page 59: ...ttings screen pertaining to that option Figure 48 The Settings screen 5 2 5 1 Select Language This screen allows you to select your preferred language Figure 49 Language Selection screen 5 2 5 2 Log i...

Page 60: ...allowed to use the technician mode for maintenance or repair of the system 5 2 5 3 Export Log This screen allows you to export any procedure data to a USB removable storage device in an easy and conv...

Page 61: ...ou to set the date and time Figure 52 The Windows Date and Time Properties screen Set the date and time according to your time zone and approve it by clicking Apply in the right lower corner of the wi...

Page 62: ...It includes 1 Dewar refilling and replacement 2 Maintain Sterility Use of sterile sleeves 3 Cryoprobe registration and connection 4 System tests To prepare the system for treatment choose the option P...

Page 63: ...each Dewar fill make sure that you are performing it properly The Dewar should never be stored with liquid nitrogen inside the system at the end of the working day For proper handling in order to ens...

Page 64: ...fter filling it frost appears on the outer wall of the container Return the Dewar to an IceCure Medical technician or an authorized distributor for inspection Warning At the beginning of the procedure...

Page 65: ...n If the carriage is not in the bottom position liquid nitrogen may spill out Close the compartment door and press NEXT on the screen Figure 56 Correct insertion and positioning of the Dewar bottom fi...

Page 66: ...es to move the Dewar carriage up or down the following popup message will appear Dewar door is open Close the door to continue Figure 59 Dewar door open warning 5 2 6 2 Sterile sleeves After filling t...

Page 67: ...gth defined in mm Ice ball shape spherical or elliptic Tip shape trocar or pencil or blunt Always monitor the ice ball growth with adequate imaging techniques If an introducer to guide the cryoprobes...

Page 68: ...dth mm Length mm Width mm Length mm 2 20 24 16 20 12 17 3 23 27 18 22 14 18 4 24 30 20 24 15 18 5 28 31 22 25 16 19 6 30 32 23 26 16 20 8 33 36 24 27 17 20 10 35 38 26 29 17 21 15 39 42 29 31 19 21 Th...

Page 69: ...25 15 21 3 25 32 22 27 17 22 4 28 34 24 29 18 24 5 31 36 25 29 19 24 6 33 38 27 31 20 25 8 36 40 29 32 21 26 10 38 43 30 33 22 27 15 44 48 33 36 24 28 The ice front of the ice ball visible under imagi...

Page 70: ...suring the distance from the probe tip till the target tissue outline including the tumor and the safety margins to be treated Example 1 Probe 3 4 elliptic shape FAP7200000 Cool zone center of probe 3...

Page 71: ...ajectory needle insertion 5 2 6 5 Cryoprobe registration Identify the cryoprobe serial number S N It appears on the cryoprobe package and or on screen and or cryoprobe plastic grip as shown in the fig...

Page 72: ...tration screen Figure 64 Invalid serial number warning Caution Verify cryoprobe S N registration by double checking the serial number on the package and on the cryoprobe itself Entering an incorrect c...

Page 73: ...n screen and screw it until a NEXT button appears on screen then confirm screwing by an additional slight rotation to confirm that probe connection is secured Remove the probe cover that protects the...

Page 74: ...t page Used probe warning message appears if a used probe is connected Replace the probe and press OK to continue Figure 67 Cryoprobe already used Expired probe warning message appears if an expired p...

Page 75: ...etion of treatment of a given patient make sure that the single use cryoprobe and single use sterile sleeve are removed and safely discarded Warning Before beginning treatment of a patient you MUST en...

Page 76: ...ystem efficacy and safety per the following instructions and per the screens presented in the figures below Prepare a container full of sterile water saline Remove the probe cover that protects the ti...

Page 77: ...will then be returned to the Main Menu screen Contact IceCure Medical technical service After successful internal test the system will display the visual inspection screen You will be prompted to insp...

Page 78: ...atment Turn OFF the system and contact IceCure Medical Choosing SUCCESS will load the treatment selection screen If for any other reason you decide to stop the procedure press CANCEL Follow system ins...

Page 79: ...and THAW cycles as shown in Fig above Select a protocol by pressing the desired icon on the touch screen A procedure screen will open After inserting the cryoprobe into the tissue you will be able to...

Page 80: ...0 rev D ProSense Confidential User Manual 80 Return to first page Figure 73 Define a treatment protocol by choosing Setup Presets on the Treatment Selection screen see no 1 Figure 74 Edit Presets in t...

Page 81: ...the screen the EDIT PRESET screen will load Please follow the NEXT steps 1 Choose the number of freeze cycles in the left side of the screen 2 Decrease increase the time for every cycle using icons E...

Page 82: ...IceCure Medical Ltd DSR3210000 rev D ProSense Confidential User Manual 82 Return to first page Figure 76 Steps for adding a protocol...

Page 83: ...rocess is very similar to that of adding a new protocol Figure 77 Edit Preset screen 5 2 7 5 Manual freeze mode The manual freeze mode allows you to perform a cryotherapy procedure without setting its...

Page 84: ...5 3 2 Preliminaries Before operating ProSense cryoablation system make sure you have completed all pre operational stages Warning Insertion of the cryoprobe into the target tissue is performed under t...

Page 85: ...n For optimal probe positioning please note the following Probe Diameter Gauge Shaft Length Tip 3mm Tip Shape Ice Ball Shape Cool Zone Center From needle tip mm Part Number 3 4 mm 10G 127 mm Trocar Sp...

Page 86: ...t length The order in which you follow these steps is essential for maintaining sterility and patient safety First insert the probe tip into the target tissue Be aware of the markings on the probe the...

Page 87: ...served during use for signs of unwanted freezing Warning You must NOT allow the freeze process to start before the cryoprobe active area is actually within the target tissue The practitioner can hold...

Page 88: ...ways monitor the ice ball size during the entire procedure IceCure Medical recommends using Pause only if necessary 5 3 4 1 Manual freeze mode Choosing the Manual freeze mode will open the treatment s...

Page 89: ...al Mode The progress of the freeze cycle will be shown on the screen with a second counter and a blue active progress line The FREEZE icon will change to a THAW icon and will allow you to move from fr...

Page 90: ...screen in Manual Mode During the manual procedure the system provides information regarding treatment progress The left side of the screen displays the Current Step freeze THAW or EXTRACTION cycle an...

Page 91: ...e icons on the left side of the screen to add subtract 15 seconds with each push At the end of the last freeze step in automatic mode the EXTRACTION step will begin and the EXTRACTION screen will be d...

Page 92: ...ll melts partially or totally depending on the THAW time and the tissue properties It is clinically important to have a THAW cycle between two freeze cycles and to keep the probe location steady in th...

Page 93: ...rget tissue and then press FINISH Do not force removal of the cryoprobe from the tissue as it might increase the risk of hematoma If the cryoprobe cannot easily be extracted from the tissue press the...

Page 94: ...ract screen appears for a few seconds and is replaced automatically by the Completed screen Figure 90 Completed screen with 3 options Extraction Relocate and Finish To continue the warming press the E...

Page 95: ...ep or wait for passive thaw until the cryoprobe can be withdrawn easily Warning DO NOT push the EXTRACTION button when the cryoprobe is not within the target tissue as skin burns could occur and not b...

Page 96: ...dential User Manual 96 Return to first page Figure 92 Completed screen without Extraction option In case Relocate is pressed the Treatment selection screen appears and the dewar needs to be refilled F...

Page 97: ...locate screen replace Dewar when required and follow instruction for freeze cycle The message Please wait shows up 5 3 7 Show Last Treatment The last treatment will be displayed by choosing SHOW LAST...

Page 98: ...se Confidential User Manual 98 Return to first page Figure 96 Last Treatment screen after relocation Figure 97 Last Treatment screen after more than 3 freeze cycles without relocation Figure 98 Last T...

Page 99: ...me of the procedure First always have an additional full Dewar ready in case you may need it for a longer freeze time At every THAW the system will automatically ask if you want to replace the Dewar s...

Page 100: ...that it is safe to replace the Dewar and you will get the Replace Dewar screen figure below Please insert a full Dewar in place of the old one and only then press OK to continue At the same time you w...

Page 101: ...new Dewar is complete the system will come back to the THAW cycle figure below To go to the NEXT freeze cycle you have to press SKIP even if the time to complete the replacement exceeded the preset T...

Page 102: ...refill the Dewar in Freeze cycle see fig below Figure 105 Replacement during Freeze in case of empty Dewar If you press OK you can replace a Dewar and continue the procedure The system will move to Ma...

Page 103: ...Confidential User Manual 103 Return to first page Figure 106 Procedure stopped due to Low Nitrogen If you press OK you will get an Extraction Completed screen with 3 options Extraction Relocate and F...

Page 104: ...deactivated and the sensor can be easily withdrawn Never use excessive force to extract the temperature sensor 5 4 2 Removing the cryoprobe from the cryohandle When a Hose holder is used during the pr...

Page 105: ...used pull the gray part of the cable connector backwards to release it and then pull the cable connector away from the front panel dispose of it appropriately 5 4 5 Exiting the ProSense cryoablation s...

Page 106: ...OFF the mechanical ON OFF button and unplug the electrical cable Clean the system following instructions in section 8 1 and move the system to its storage location 5 5 Instruct patients o To remove g...

Page 107: ...message and number follow the system instructions Figure 112 System Fail example screen 2 If you are in the middle of a cryotherapy procedure wait for passive THAW and then carefully remove the cryopr...

Page 108: ...rical cable Call IceCure Medical for technical service before restarting the ProSense cryoablation system 5 6 2 1 Emergency Stop button The fastest way to end a procedure is to press the RED HANDLE bu...

Page 109: ...there is NO other choice Wherever possible the system should be shut down by the standard procedure Excessive use of the Emergency Stop button may damage the system After pressing the emergency stop...

Page 110: ...the Technician icon The technician mode can only be accessed by an IceCure Medical authorized technician and is restricted by a password It is used for maintenance of the system Warning Never enter th...

Page 111: ...orner Other status messages such as the type of cryoprobe currently connected will be displayed in the left bottom corner For Example Figure 115 Status message example 6 3 2 Warning messages Critical...

Page 112: ...e user should carefully follow system instructions If an error appears during a treatment it will appear in the following format Figure 117 Error message format example Warning When the system shuts i...

Page 113: ...eturn to first page 7 ACCESSORIES 7 1 Cryoprobe 7 1 1 Single use sterile cryoprobe Figure 118 The cryoprobe components the figure is for illustration only There are various cryoprobe configurations Fo...

Page 114: ...of an introducer that is too big and create an air barrier between the freezing power of the probe and the tissue inject 5cc of sterile saline or water into the introducer lumen to improve heat exchan...

Page 115: ...e consideration of the user on which side and where to position the holder arm according to the room and table conditions To use the holder safely position the Holder base on the CT table under the pa...

Page 116: ...it with a clean cloth or with forced air and wrap it in another clean cloth until disinfecting it according to the disinfection acceptable standards in your institution If Holder was used during proce...

Page 117: ...up to the cryoprobe 8 3 Periodic servicing Caution The ProSense cryoablation system is not user serviceable Refer all service issues to IceCure Medical s Customer Service Department If there is any ma...

Page 118: ...rev D ProSense Confidential User Manual 118 Return to first page Caution The system will not allow additional treatment when zero procedures are left to maintenance Make sure to call IceCure Medical s...

Page 119: ...er open the console Only an IceCure Medical technician or authorized representative is allowed to open the console for maintenance or to repair the system Warning Do not attempt to perform any trouble...

Page 120: ...ct IceCure Medical service Dewar compartment door does not open Door held shut by magnet Try to open the door using reasonable force If door will not open contact IceCure Medical service The door is o...

Page 121: ...tact IceCure Medical service LED does not light up Burned out LED or it should not be lighting up at given time Check user manual to verity that the LED should light up If yes contact IceCure Medical...

Page 122: ...e emergency stop button if pressed and wait for computer re boot If happened during a procedure replace the probe when required automatically by the system Screen is stuck Controller stops working Con...

Page 123: ...er Manual 123 Return to first page Problem Probable Cause Action click O K when the message pops up but to wait until the message disappear by itself In case you clicked O K the screen freeze till the...

Page 124: ...SUCCESS If not start over with a new sterile probe if required Procedure 10 Select treatment modality Preset Cycles Manual Mode You can modify the cycles as needed during procedure 11 Insert the prob...

Page 125: ...yogen Liquid Nitrogen Boiling point 196 C Type of cryometer thermocouple type K Environmental conditions Temperatures Operating 10 C 40 C 50 F 104 F Transportation and Storage 0 C 70 C 32 F 158 F Rela...

Page 126: ...ly exercised option result in exclusion of the equipment from warranty coverage This warranty shall not apply to electron tubes lamps fuses batteries and any other parts which carry separate warrantie...

Page 127: ...IceCure Medical Ltd DSR3210000 rev D ProSense Confidential User Manual 127 Return to first page 13 CUSTOMER COMPLAINT FORM Section 1 Customer complaint To be filled by customer complaint recipient...

Page 128: ...resupport icecure medical com support icecure medical com Tel 1 646 844 3066 Toll free 888 516 7389 OR IceCure Medical Ltd HaEshel 7 2nd floor Southern Industrial Park Caesarea 38900 Israel support ic...

Page 129: ...environment specified below The customer or the user of the model ProSense Cryotherapy product should ensure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environm...

Page 130: ...e recommended separation distance in meters m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency...

Page 131: ...transmitters and the model ProSense Cryotherapy product as recommended below according to the maximum output power of the communications equipment Rated maximum output of transmitter W Separation dist...

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