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IceCure™ Medical Ltd.

DMS-7064 rev. C

ProSense™

Confidential

User Manual

European User Manual

Safe Operation in Percutaneous Procedures ........................................................... 86

Preliminaries ............................................................................................................ 86

Freeze Step ............................................................................................................... 89

Thaw ......................................................................................................................... 94

Extraction ................................................................................................................. 94

Show Last Treatment ............................................................................................... 99

Replace (refill) the Dewar during a cryoablation procedure ................................. 100

Post-operational stages ......................................................................................... 104

Removing the temperature sensor from tissue ..................................................... 104

Removing the cryoprobe from the cryohandle ..................................................... 105

Disassembling the support device - Hose-Holder .................................................. 105

Disassembling the temperature sensor ................................................................. 105

Exiting the ProSense™ cryoablation system treatment mode

.............................. 106

General advice for patients .................................................................................... 107

System failures ....................................................................................................... 107

ProSense™ cryoablation system failure

................................................................. 107

ProSense™ cryoablation system touch screen failure

........................................... 108

COMPUTER INTERFACE .................................................................................. 110

The technician menu .............................................................................................. 110

Reading the screen ................................................................................................. 110

System messages ................................................................................................... 110

Status messages ..................................................................................................... 110

Warning messages ................................................................................................. 111

Error messages ....................................................................................................... 111

ACCESSORIES ................................................................................................. 113

Cryoprobe .............................................................................................................. 113

Introducer .............................................................................................................. 114

Foot pedal (Not available in some regions, e.g. China) ......................................... 115

Temperature sensor (Not available in some regions, e.g. China) .......................... 115

Holder (Not available in some regions, e.g. China) ................................................ 115

SYSTEM MAINTENANCE ................................................................................. 116

General cleaning .................................................................................................... 116

Sterility ................................................................................................................... 117

Periodic servicing ................................................................................................... 117

TROUBLESHOOTING ....................................................................................... 118

General ................................................................................................................... 118

Troubleshooting guide ........................................................................................... 118

ProSense™ cryoablation system

- Step-by-Step procedure .............................. 123

SYSTEM SPECIFICATIONS ................................................................................ 124

LIMITED WARRANTY CERTIFICATE .................................................................. 125

CUSTOMER COMPLAINT FORM ...................................................................... 126

REPORT CUSTOMER COMPLAINT .................................................................... 127

Cryoablation Clinical References..................................................................... 128

Manufacturer’s Declaration of the EUT

........................................................... 131

Содержание ProSense FAS3000000

Страница 1: ...ntact your IceCure Medical representative IceCure Medical Inc icecuresupport icecure medical com US Canada Toll Free 1 888 902 5716 IceCure Medical Ltd 7 Haeshel St 2nd floor P O B 3163 Caesarea 30795...

Страница 2: ...per use 15 Cyber security 18 Operating warnings 19 Liquid nitrogen 20 Danger explosion and fire hazard 21 Opening the Dewar compartment 21 Liquid nitrogen Safety 21 Burn hazards 24 Grounding 24 Steril...

Страница 3: ...able in some regions e g China 48 Temperature sensor TS 48 Dewar storage cases 50 Operational details 50 Starting the system 51 System functional tests 52 Cryoablation procedure 52 Extraction step 52...

Страница 4: ...tem failure 107 ProSense cryoablation system touch screen failure 108 COMPUTER INTERFACE 110 The technician menu 110 Reading the screen 110 System messages 110 Status messages 110 Warning messages 111...

Страница 5: ...Opening Restriction sticker 37 Figure 22 Single use Introducer labels 37 Figure 23 Front and back view of the ProSense cryoablation system with numbered components 42 Figure 24 ProSense transportation...

Страница 6: ...Figure 59 Dewar door open warning 68 Figure 60 Ice ball measurement ranges 69 Figure 61 Cryoprobe the figure is for illustration only 71 Figure 62 Cryoprobe registration screen 72 Figure 63 Invalid s...

Страница 7: ...question 100 Figure 101 Lowering the Dewar during Thaw screen 101 Figure 102 Replace Dewar screen 101 Figure 103 Replacement done follow up screen 102 Figure 104 Replacement was completed before the T...

Страница 8: ...ltrasound device to provide real time visualization of the cryosurgical procedure This cryotherapy should only be executed if the operative standard therapy and established therapies cannot be applied...

Страница 9: ...cell tumors of the eyelid or canthus area ulcerated basal cell tumors dermatofibromas small hemangiomas mucocele cysts multiple warts plantar warts hemorrhoids anal fissures perianal condylomata pilon...

Страница 10: ...by IceCure Medical certified personnel Warning Do not use this system if you have not been adequately trained in its use Clinical decisions The practitioner is solely responsible for all clinical use...

Страница 11: ...nced Operator You are a qualified ProSense cryoablation system Advanced Operator only if you meet all of the following criteria You have taken a certified ProSense cryoablation system technical operat...

Страница 12: ...Caution it deals with danger to equipment and data Caution It is dangerous for equipment and data to do this Basic safety principles All safety issues explained in this manual are grouped within the f...

Страница 13: ...been made to make this User Manual comprehensive certain sections may be unclear or difficult to understand depending on the user s background and experience Do not use this system if there is any in...

Страница 14: ...the system for a given medical condition lies with the practitioner While experience has shown that the system is useful for certain applications in cryosurgery no representation or warranty is made t...

Страница 15: ...system Caution After 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 Warning The cryoablation sys...

Страница 16: ...cryoablation system Make sure to use only an approved IceCure Dewar for your system Caution Turn off the cryoablation system and lock the rollers when the system is not in use Before you start a proc...

Страница 17: ...Avoid pinching cutting or pulling the cryoprobe Do not use damaged cryoprobes 3 Do not grasp cryoprobes with auxiliary instruments as this may cause damage to the cryoprobe shaft Warning If a sterile...

Страница 18: ...WiFi protocols Caution Use USB2 0 ash drives only to export reports or log files Importing any data or software may corrupt the ProSense Cryoablation System Do not connect any other USB devices to th...

Страница 19: ...dle exercise caution to prevent a stabbing injury from the cryoprobe and maintain sterility of the cryohandle and cryoprobe Warning Before removing the temperature sensor from the tissue make sure the...

Страница 20: ...e Thaw In both cases use skin protection techniques Warning Pay attention to the cryoprobe during functional test bubbles leak or frost on shaft may signal internal problems that could be hazardous Wa...

Страница 21: ...old burns do not transfer a Dewar containing liquid nitrogen unless it is covered with its designated lid Warning Follow the specific instructions on how to fill and transfer a Dewar as described in s...

Страница 22: ...they may be discarded quickly in the event that any liquid nitrogen splashes into them If you are working with open containers of liquid nitrogen boots should be worn and trousers should not be tucke...

Страница 23: ...and in accordance with local laws and safety rules Warning Do not attempt to dispose of residual or unused quantities of liquid nitrogen For safe disposal contact your supplier For emergency disposal...

Страница 24: ...st be closely observed during use for signs of unwanted freezing Grounding Warning To avoid risk of electric shock this equipment must only be connected to an electricity network with protective groun...

Страница 25: ...ct IceCure Medical for advice Caution Do not pull the system by the cryohandle or hose The hose should be bent gently during procedure Emergencies and errors Emergency Stop button Caution Use the Emer...

Страница 26: ...ch OFF the mechanical ON OFF switch and unplug the electrical cable Predictable Adverse Events Warning Regulatory requirements mandate that serious adverse events be reported to the relevant regulator...

Страница 27: ...tension low blood pressure cough residual neuromuscular block in recovery intubation complications slow to regain consciousness anesthetic turn off too early Severe adverse events hypoxia hypotension...

Страница 28: ...ion bleeding DVT cystitis Hematuria hypotension Idiosyncratic reaction ileus infection pleural effusion pneumothorax cryoprobe site paresthesia mild renal failure renal infract voiding dysfunction uri...

Страница 29: ...aspartate aminotransferase and or ALN Alanine aminotransferase level reflects hepatocellular damage of normal liver parenchyma life threatening serum bilirubin level elevation hemorrhage cryoshock hy...

Страница 30: ...procedure ensure that the previously used single use cryoprobe temperature sensor introducers and sterile sleeve have been removed and discarded Any used cryoprobe introducer and temperature sensor m...

Страница 31: ...risk of electrical shock do not remove cover Refer servicing to qualified service personnel Figure 9 MLP7100100 MLP7200100 Single use cryoprobe label various options of shapes tip length and sizes Fi...

Страница 32: ...ProSense Confidential User Manual 32 European User Manual Note Images of labels and stickers in this section are for reference only Figure 1 ON OFF Switch label Figure 2 Emergency Stop button label Fi...

Страница 33: ...roSense Confidential User Manual 33 European User Manual Figure 4 ProSense straight handle Identification labels Figure 5 Follow Instructions for Use Figure 6 High Voltage Caution Figure 7 Label 6 Lin...

Страница 34: ...ProSense Confidential User Manual 34 European User Manual Figure 9 Risk of Explosion label Figure 10 Single use cryoprobe label A B C Figure 11 Color Tag Labels for Cryoprobes A and Introducers B and...

Страница 35: ...ProSense Confidential User Manual 35 European User Manual Figure 12 Single use temperature sensor label Figure 13 Liquid Nitrogen Dewar label Figure 14 Black Dewar label Figure 15 Cold area sticker F...

Страница 36: ...IceCure Medical Ltd DMS 7064 rev C ProSense Confidential User Manual 36 European User Manual Figure 17 BF Applied Parts symbol Figure 18 Holder label Figure 19 Shipping and storage conditions sticker...

Страница 37: ...Crate Opening Restriction sticker Figure 22 Single use Introducer labels Important Symbols and Labels A number of harmonized symbols relating to safety requirements and standards are found on the ProS...

Страница 38: ...r Manual 38 European User Manual Symbol Meaning Caution Warning Applied parts Serial number Manufacturer Date of manufacture Do not reuse Use by Date Catalogue number Do not resterilize Sterilized usi...

Страница 39: ...es Electrical and electronic equipment contain hazardous substances which when disposed of incorrectly may leak into the ground This can contribute to soil and water pollution which is hazardous to hu...

Страница 40: ...et in the European Economic Area Transportation and storage atmospheric pressure limits Transportation and storage humidity limits Storage temperature limits Keep away from sunlight Keep dry CAUTION U...

Страница 41: ...7064 rev C ProSense Confidential User Manual 41 European User Manual Symbol Meaning Lock tighten two parts together in a fixed position MR safety warning system materials are not compatible with magn...

Страница 42: ...in a number of medical fields The system is designed to destroy tissue by the application of extreme cold temperatures ProSense cryoablation system is indicated for patients whom the practitioner has...

Страница 43: ...four rollers for ease of movement Each roller is equipped with directional and rotational brakes for system immobilization Located on the top of the chassis are a touch screen control panel and a cryo...

Страница 44: ...se joins the cryohandle to the siphon inside the chassis This permits liquid nitrogen to flow from the main chassis to the cryoprobe Caution Do not pull the system by the cryohandle or hose The hose s...

Страница 45: ...Figure 27 User Manual navigation panel You can select a page number zoom out or zoom in scroll along the document By pressing on the x right corner you will exit the User Manual If you prefer you can...

Страница 46: ...front panel of the ProSense cryoablation system unit The cryoprobe is connected to the cryohandle The cryohandle allows for maneuvering of the cryoprobe within the target tissue Earlier straight cryoh...

Страница 47: ...ace for keeping the plug while performing the procedure Humidity is a crucial issue to address in cryosurgery systems After every procedure close the handle plug on the Cryohandle Perform functional t...

Страница 48: ...the Freeze step and confirming actions of the active buttons on the screen Figure 34 Action button as displayed on screen several of the options Figure 35 Foot pedal Temperature sensor TS The temperat...

Страница 49: ...gure Figure 36 Temperature sensor and its components If you decide to use a temperature sensor connect it per the following instructions while maintaining sterility 1 Remove the temperature sensor fro...

Страница 50: ...located at the back of the chassis providing storage for the Dewars When placing the Dewars inside the storage shelf make sure they are well installed see fig below Figure 38 Dewar storage cases the c...

Страница 51: ...liquid nitrogen should be performed by authorized personnel Care must be taken when filling the system Dewar Standard guidelines for safe handling and storage of liquid nitrogen should be followed Th...

Страница 52: ...cryoablation procedure can only be performed after the cryoprobe has been inserted in the target tissue It can be activated by Manual mode controlled by the user or by Automatic mode pre programmed a...

Страница 53: ...erious injury or burn if handled improperly Local laws and safety rules regarding the maintenance and handling of liquid nitrogen Dewars should always be observed Setup warnings and cautions Warning I...

Страница 54: ...cordingly 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 wall power outlet Good grounding is essentia...

Страница 55: ...d up to LN2 protection Installation Warning The ProSense cryoablation system must be unpacked installed and tested by an IceCure Medical technician or by a technician authorized by IceCure Medical to...

Страница 56: ...cations the practitioner should follow standard clinical procedures that are not within the scope of this user manual The device materials are not compatible with magnetic resonance imaging thus it is...

Страница 57: ...sure the lesion with an imaging 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...

Страница 58: ...monitoring the medical procedure In case of open surgery or superficial cryotherapy no external imaging device is required The mechanical power switch is OFF The cryohandle hose and cradle are all cl...

Страница 59: ...is is an optional BLUE button on the inner side of cryohandle It activates deactivates the Freeze step and confirms actions of the active buttons on the screen Figure 44 Action button as displayed on...

Страница 60: ...available by choosing the Settings button at the bottom of the touch screen Figure 46 Activating the Settings option from the Main Menu screen Choosing the Settings button will load the settings scre...

Страница 61: ...an mode Choosing the Technician Mode icon will load a Technician Mode entry screen that is used for maintenance of the system The technician mode can only be accessed by an IceCure Medical authorized...

Страница 62: ...ct a USB flash drive and press OK Press OK to export the log file to the USB drive Press Cancel to return to Settings screen If export fails the message in the status area reads Export failed make sur...

Страница 63: ...the system Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure Preparing the system for treatment The system will guide the user through a system p...

Страница 64: ...stem for treatment by pressing Prepare for Treatment on Main Menu screen 5 2 6 1 Dewar Prepare the Dewar for treatment as per the following instructions and as detailed on the system screen see Fig be...

Страница 65: ...ormed the following message is displayed Figure 55 Freezing Has Stopped Pop up Message If such message appears remove the Dewar from the system clean its opening from ice and reinsert a full Dewar Cau...

Страница 66: ...ystem In the event that a Dewar is damaged use another Dewar to continue the procedure Warning To avoid spillage and cold burns do not transfer a Dewar containing liquid nitrogen unless it is covered...

Страница 67: ...tion 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 first Make sure the Dewar positioned freely i...

Страница 68: ...nt please work under sterile conditions Cover all relevant accessories in the sterile area with the suitable single use sleeves to ensure sterility 5 2 6 3 Cryoprobe Selection Select a cryoprobe accor...

Страница 69: ...e ball will be created on this introducer part In such a case injecting 5cc of sterile saline or water into the introducer lumen can improve heat exchange between the cryoprobe and the tissue Warning...

Страница 70: ...Ball Dimensions at Various Temperatures over Time 3 C 20 C 40 C Time minutes Width mm Length mm Width mm Length mm Width mm Length mm 2 19 34 16 30 13 27 3 24 36 20 32 16 28 4 28 38 23 34 17 28 5 30 4...

Страница 71: ...42 27 36 21 30 6 35 46 29 38 23 32 8 37 46 31 37 23 32 10 41 48 33 38 25 33 15 46 52 36 41 26 35 The ice front of the ice ball visible under imaging is around 3 C 5 2 6 4 Cryoprobe registration Ident...

Страница 72: ...aution Verify cryoprobe S N registration by double checking the serial number on the package and on the cryoprobe itself Entering an incorrect cryoprobe S N registration will result in cryoprobe nulli...

Страница 73: ...HERE label 2 Remove the plug that covers the cryoprobe connection point 3 Insert the cryoprobe into the insertion point in the handle as shown on screen and screw it until a Next button appears on scr...

Страница 74: ...it Warning After completion 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...

Страница 75: ...struments should be handled with care to avoid damage to the cryoprobe 2 Avoid pinching cutting or pulling the cryoprobe Do not use damaged cryoprobes 3 Do not grasp cryoprobes with auxiliary instrume...

Страница 76: ...robe cannot be screwed out of the cryohandle the system should not be turned on before disengaging the cryoprobe from the cryohandle 7 Close the handle plug on the cryohandle 8 Start the system using...

Страница 77: ...equested to remove the cryoprobe safely from the cryohandle You will then be returned to the Main Menu screen Contact IceCure Medical technical service After successful internal test the system will d...

Страница 78: ...o safely remove the cryoprobe from the cryohandle You will then be returned to the Main Menu screen Check that the Dewar is full and replace the cryoprobe and start again If the problem recurs do not...

Страница 79: ...om the tip to the center of the cooling zone Place the center of the cooling zone in the center of the target tissue to achieve accurate killing zone Use the below formula to calculate the position of...

Страница 80: ...to the treatment on baseline tumor measurements Figure 69 Pre Planning trajectory needle insertion in breast applications 5 2 7 2 Cryoprobe Placement Calculation during a procedure After the system t...

Страница 81: ...gure 72 Planned Margin 5 Press Calculate to calculate the cryoprobe placement The calculated result X that will appear is the distance the Cryoprobe should pass through to ensure that the center of th...

Страница 82: ...een as shown below Type of treatment is determined by the number and duration of Freeze and Thaw steps and depends also on the practitioner s preferred way of work Figure 74 Treatment Selection screen...

Страница 83: ...n to define treatment protocol is available before system test by using EDIT PRESETS in the Main Menu screen As shown in the figure below Choosing either option will open the PRESET SETUP screen and y...

Страница 84: ...rotocol press one of the empty slots in the screen the Edit Presets screen will load Perform the following steps 1 Choose the number of Freeze steps in the left side of the screen 2 Decrease increase...

Страница 85: ...or adding a protocol The calculated total time of all steps is displayed on the left pane of the screen 5 2 8 4 Editing a protocol If you choose to edit an existing protocol see Figure 76 the EDIT PRE...

Страница 86: ...reatment site is required Skin protection techniques must be implemented to avoid thermal injury to the skin Skin protection techniques include but are not limited to dripping room temperature sterile...

Страница 87: ...form a 3 mm skin incision for example using 11 blade Position the tip of the cryoprobe according to Cryoprobe placement calculation shown on the screen Caution Artifacts from the devices may appear in...

Страница 88: ...eter 10G FAP7200000 Trocar FAC9100000 167 mm Fit to needle diameter 10G FAP7400000 and FAP7410000 Trocar FAC9200000 IceCure Medical systems needles introducers cryoprobes and accessories may not be av...

Страница 89: ...l zone center is aligned with the center of the target tissue The practitioner can hold the cryohandle for the duration of the cryoablation procedure or use a hose support device 5 3 3 1 Pause Option...

Страница 90: ...or the ice ball size during the entire procedure using proper imaging modalities 5 3 3 2 Manual Freeze mode Choosing the Manual freeze mode will open the treatment screen for manual mode as show in Fi...

Страница 91: ...Freeze step to Thaw step by pressing the Thaw icon or the Action button on the cryohandle Figure 85 Thaw screen in Manual Mode You can continue to move between steps using the same method To end the p...

Страница 92: ...e and treatment format If you perform more than 3 consecutive Freeze Thaw steps the right side will only display the last 5 actions due to screen size limitation 3 Freeze Thaw steps The system allows...

Страница 93: ...can move from the automatic mode AT ANY TIME by pressing the Manual mode button on the screen without interrupting the procedure When in Manual you can t go back to Automatic mode o If you choose to d...

Страница 94: ...Its purpose is to allow the cryoprobe s removal from the target tissue in the fastest and safest way In order to be able to get the Extraction option the Freeze time should have been at least 2 minute...

Страница 95: ...l then perform several verification steps and it will inform you when it is safe to disengage the cryoprobe In case the Extraction process isn t available wait for passive Thaw Figure 89 Extraction sc...

Страница 96: ...ter Extraction step before removing the cryoprobe from the tissue make sure that the freeze effect has been deactivated so that the cryoprobe can easily be removed from the tissue Do not force removal...

Страница 97: ...2 Passive Thaw screen For an additional Freeze step press the RELOCATE icon and select a treatment cycle To end procedure press Finish Figure 93 Completed screen without Extraction option In case Relo...

Страница 98: ...an User Manual Figure 94 Cryoprobe Placement Calculation screen during relocate Figure 95 Dewar Replacement screen Figure 96 Dewar Replacement finished screen After each relocation replace the Dewar w...

Страница 99: ...layed by choosing LAST TREATMENT icon on the Main Menu screen In this screen you can see details of the last procedure that was performed including date time treatment mode cryoprobe type and duration...

Страница 100: ...step If the Freeze step is 5 minutes or longer the system will request Dewar refill between the steps It is recommended to have an additional full Dewar ready in case you need it for a longer freeze t...

Страница 101: ...will inform you 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 th...

Страница 102: ...e new Dewar is complete the system will resume the Thaw step figure below To go to the next Freeze step you have to press Skip even if the time to complete the replacement exceeded the preset Thaw tim...

Страница 103: ...refill the Dewar in Freeze step see fig below Figure 106 Replacement during Freeze in case of empty Dewar If you press OK you can replace the Dewar and continue the procedure The system will move to...

Страница 104: ...rom tissue At the end of the cryotherapy procedure the temperature sensor should be removed from the tissue by carefully pulling on it The extraction should be done only after a passive Thaw of a few...

Страница 105: ...it appropriately 2 Remove the single use sterile cover from the cryohandle 3 Close the cryohandle with the covering plug Figure 109 Safe to Remove cryoprobe Warning Dispose of the cryoprobe temperatur...

Страница 106: ...e end of the treatment and after removing and disassembling the cryoprobe and temperature sensor return to the Main Menu screen by pressing the MAIN MENU icon on the right lower corner Figure 110 Prot...

Страница 107: ...llows Remove gauze dressing after 24 hours and expect minimal discharge Adhesive skin closure should be removed after 7 days if it has not already fallen off They may need over the counter pain reliev...

Страница 108: ...h screen failure If the touch screen shuts down you will need to shut OFF the system with the mechanical ON OFF switch and remove the plug from the power supply This will end the cryoablation procedur...

Страница 109: ...rgency Stop button only when 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...

Страница 110: ...an IceCure Medical technician or an authorized representative can access this mode for maintenance or repair of the system Reading the screen The screen within the control panel is represented by the...

Страница 111: ...ppear in the following format Figure 117 Warning message format example Pressing the OK button will indicate you have read this message and will dismiss the popup Error messages Information that preve...

Страница 112: ...s itself down due to an error contact IceCure Medical and describe the error message shown on the screen as precisely as possible Do not attempt to reuse the system before contacting IceCure Medical A...

Страница 113: ...Elliptic 20 mm FAP7200000 3 4 mm 10G 185 mm Pencil Elliptic 20 mm FAP7400000 3 4 mm 10G 185 mm Trocar Elliptic 20 mm FAP7410000 2 4 mm 13G 124 mm Trocar Spheric 10 mm FAP7600000 2 4 mm 13G 134 mm Tro...

Страница 114: ...ntroducer to guide the Cryoprobes to the tissue location is used an introducer with tight dimensions should be used The cryoablation may be affected by the use of an introducer that is too big and cre...

Страница 115: ...a If the user chooses to measure target tissue temperature during cryoablation the temperature sensor is a single use external accessory that can be connected to the main chassis To use the temperatur...

Страница 116: ...ith 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 procedure...

Страница 117: ...service issues to IceCure Medical s Customer Service Department If there is any malfunctioning of the ProSense cryoablation system please contact IceCure Medical technical support The technician shoul...

Страница 118: ...oting guide Problem Probable Cause Action Main chassis does not move Rollers are locked Unlock the rollers transport the system and lock them again If the problem persists contact IceCure Medical serv...

Страница 119: ...e Dewar is empty pop up during Freeze step while Dewar is NOT empty Machine or Cryoprobe blockage The system will alert of Dewar is empty and elevator will descent This is proper system function to re...

Страница 120: ...m a new procedure with full Dewar and a new cryoprobe while maintaining sterility Freeze Extraction icon does not initiate the operation Faulty icon or operator misuse Try pressing the Freeze Extracti...

Страница 121: ...obe Excess pressure on the pipes main valve open procedure not completed or Dewar relief valve malfunction When initial leak is detected screw the cryoprobe back in place Make sure that the procedure...

Страница 122: ...different from that to which the other device s are connected If the problem persists contact IceCure Medical service Long wash popup message System pipes blockage The user will have to wait until th...

Страница 123: ...ated at the tip of the cryoprobe 9 If the test was successful press SUCCESS If not start over with a new sterile cryoprobe if required Procedure 10 Select treatment modality Preset Cycles Manual Mode...

Страница 124: ...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 20 C 70 C 4 F 158 F Rela...

Страница 125: ...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 warranties...

Страница 126: ...IceCure Medical Ltd DMS 7064 rev C ProSense Confidential User Manual 126 European User Manual CUSTOMER COMPLAINT FORM Section 1 Customer complaint To be filled by customer complaint recipient...

Страница 127: ...re medical com support icecure medical com US Canada Toll Free 1 888 902 5716 OR IceCure Medical Ltd HaEshel 7 2nd floor P O B 3163 Caesarea 3079504 Israel support icecure medical com Tel 972 4 623 03...

Страница 128: ...ort of a multi institutional trial Ann Surg Oncol 2004 May 11 5 542 9 10 Simmons RM Ballman KV Cox C Carp N Sabol J Hwang RF Attai D Sabel M Nathanson D Kenler A Gold L Kaufman C Han L Bleznak A Stanl...

Страница 129: ...moto K Asakura K Tsukada N Kawamura M Nomori H Kuribayashi S Percutaneous cryoablation of lung tumors feasibility and safety J Vasc Interv Radiol 2012 Mar 23 3 295 302 quiz 305 doi 10 1016 j jvir 2011...

Страница 130: ...tate of the Art in Interventional Oncology Benign and Metastatic Disease Involving Bone Radiology 262 3 765 780 39 Coupal TM Mallinson PI Munk PL Liu D Clarkson P Ouellette H CT guided percutaneous cr...

Страница 131: ...vironment 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 environmen...

Страница 132: ...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 r...

Страница 133: ...ransmitters 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 dista...

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