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IceCure DSR3200000, User Manual

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IceCure DSR3200000 User Manual Download Page 125

 
IceCure

™

 Medical Ltd. 

DSR3200000 rev. G      

 ProSense

™

  

Confidential 

 

User Manual  

 

 

125 

 Return to first page                                                                                                        U.S User Manual  

Problem 

Probable Cause 

Action 

Ice formation on the 
hose, the cryohandle 
and sterile sleeve 
 

Low temperature and long 
freezing cycles may cause 
moisture to form ice particles. 

This is not an operational problem. 
Wipe OFF accumulated ice with 
clean sterile gauze. 

Nitrogen leaks from 
cryoprobe, cryohandle 
or system during the 
cryotherapy procedure. 

Cryoprobe is not well connected 
or pipes are faulty. 

Push the warm button or 
emergency button and contact 
IceCure Medical service. 

Unreasonable 
temperature readings of 
temperature sensor 

Temperature sensor or system 
malfunctions. 

Check that the temperature 
sensor is well connected.  
If so, change the temperature 
sensor. 
If temperature reading is still 
unreasonable, continue the 
procedure without a temperature 
sensor.  
If problem persists, contact 
IceCure Medical service. 

Cryoprobe cannot easily 
be removed from target 
tissue. 

 EXTRACTION (WARM) process 
malfunction 

Do not use force in attempting to 
remove the cryoprobe from the 
tissue.  
Wait a few minutes and try 
removing it gently again. 
If problem persists, contact 
IceCure Medical service.   

Cryoprobe is difficult to 
detach from cryohandle. 

Parts are frozen together  

Try again after five minutes. If it 
still cannot be detached, contact 
IceCure Medical service. 

Nitrogen leak when 
trying to remove the 
cryoprobe 

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 has 
ended, wait 3 minutes and try 
removing the cryoprobe again. If 
nitrogen is still leaking contact 
IceCure Medical service. 

Computer failure due to 
hardware fault 

Unknown 

Mechanical shut down of the 
system using the ON/OFF switch at 
the back of the system or 
emergency stop. 
Then turn on the system (after 
releasing the emergency stop 
button, if pressed) and wait for 
computer re-boot. 
If happened during a procedure 
replace the cryoprobe when 
required automatically by the 
system. 

Screen is stuck/ 
Controller stops 

Unknown 

Mechanical shut down of the 
system using the ON/OFF switch at 

Summary of Contents for DSR3200000

Page 1: ...ical representative IceCure Medical Inc 41 18 Christine Ct Fair Lawn NJ 07410 USA icecuresupport icecure medical com Tel 1 646 844 3066 IceCure Medical Ltd 7 Haeshel St 2nd floor P O B 3163 Caesarea 3...

Page 2: ...7 2 3 Operating warnings 19 2 4 Liquid nitrogen 21 2 4 1 Danger explosion and fire hazard 21 2 4 2 Opening the Dewar compartment 22 2 4 3 Voltage and power ratings 22 2 4 4 Liquid nitrogen Safety 22 2...

Page 3: ...Installation 55 5 OPERATING THE SYSTEM 56 5 1 Procedure Overview 56 5 2 Pre operational stages 56 5 2 1 Preparing the system for procedure 56 5 2 2 Preparing the patient for procedure 57 5 2 3 Switchi...

Page 4: ...USTOMER COMPLAINT FORM 130 14 REPORT CUSTOMER COMPLAINT 131 15 Cryoablation Clinical References 132 16 Manufacturer s Declaration of the EUT 135 Figures Figure 1 Label 1 ON OFF mechanical button MLS10...

Page 5: ...The 90 degrees cryohandle No 1 and connected Cryoprobe No 2 46 Figure 31 Handle plug holder and handle plug 46 Figure 32 The Cryohandle closed with the plug on the Handle holder 47 Figure 33 The Holde...

Page 6: ...ure 74 Edit Presets in the Main Menu screen see no 2 83 Figure 75 Editing an existing protocol see no 1 or adding a new one see no 2 84 Figure 76 Steps for adding a protocol 85 Figure 77 Edit Preset s...

Page 7: ...ve cryoprobe 107 Figure 109 Protocol Completed screen Pressing on the Main Menu icon see no 1 will load the Main Menu screen 108 Figure 110 The Main Menu screen To shut down the system press on the Sh...

Page 8: ...ogy proctology and urology The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue liver metastases tumors skin lesions and warts...

Page 9: ...avity and ablation of leukoplakia of the mouth General Surgery Ablation of leukoplakia of mouth angiomas sebaceous hyperplasia basal cell tumors of the eyelid or canthus area ulcerated basal cell tumo...

Page 10: ...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 certified p...

Page 11: ...udes periodic maintenance and repair of the system according to requirements Warning Do not modify this equipment without authorization of the manufacturer 1 8 Advanced Operator You are a qualified Pr...

Page 12: ...to do this 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 issu...

Page 13: ...r maintenance 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...

Page 14: ...em may become 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 ProSens...

Page 15: ...dure using Ultrasound or other appropriate imaging systems Caution Artifacts from the devices may appear in the Ultrasound or CT image Warning Temperature sensor and cryoprobe insertion and navigation...

Page 16: ...tion 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 Caution The ProSense cryoablation syst...

Page 17: ...is a dedicated system part and should not be used for any other purpose Make sure to use only IceCure approved and labeled Dewars for your system Caution Dewars should always be stored with their lids...

Page 18: ...ed if mishandled Do not use a cryoprobe that has been bent dropped hit against a hard surface or compromised in any manner as damage to the cryoprobe may have occurred Warning 1 while cryoprobe is in...

Page 19: ...securely connected Warning Insertion of the cryoprobe into the target tissue is performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure Medic...

Page 20: ...get tissue as skin burns could occur and not before the freezing protocol is completed unless you want to shorten the procedure due to clinical judgment Warning Never detach the cryoprobe from the cry...

Page 21: ...e performance of the system Warning Use safety measurements as Cryogenic gloves and face shield for protection when filling in the 2 liter Dewar and or 20 liter Dewar 2 4 1 Danger explosion and fire h...

Page 22: ...6 1 Dewar 2 4 3 Voltage and power ratings Caution Verify that the ProSense cryoablation system complies with the local voltage line 2 4 4 Liquid nitrogen Safety Warning Liquid nitrogen may cause if th...

Page 23: ...id nitrogen may stick to the skin and tear flesh when attempting removal Protective clothing can reduce the hazards of handling liquid nitrogen Insulated or cryogenic gloves should always be worn when...

Page 24: ...ust always be done in the original container and in accordance with local laws and safety rules Do not attempt to dispose of residual or unused quantities of liquid nitrogen For safe disposal contact...

Page 25: ...ezing 2 4 6 Grounding Warning To avoid risk of electric shock this equipment must only be connected to a supply main with protective grounding 2 4 7 Sterility Warning The cryoprobes and the temperatur...

Page 26: ...cryoprobe Warning Never use excessive force to insert or remove a cryoprobe from the cryohandle If moderate force is not sufficient contact IceCure Medical for advice Caution Do not pull the system by...

Page 27: ...reen as precisely as possible Do not attempt to reuse the system before contacting IceCure Medical After reporting or making note of the error message switch OFF the mechanical ON OFF button and unplu...

Page 28: ...ombosis rectourethral fistula scrotal edema sepsis skin burn stricture of the collection system or ureters stroke thrombosis thrombus embolism transient ischemic attack tumor seeding UPJ obstruction i...

Page 29: ...ility of medical electrical equipment See chapter 16 Manufacturer s Declaration of the EUT 2 9 Equipment classification Electric shock protection Class I Type BF Protection against ingress of liquids...

Page 30: ...LN2 Dewars Label 16 Applied parts Label 17 Holder Label 18 Shipping Art Work Label 19 Shipping Art Work UCG1000025 Label 20 Only IceCure Medical technician is authorized to open the crate Label 21 Sin...

Page 31: ...l Figure 3 Label 3 Identification MLS3080104 Rev A 220 240 VAC MLS3080103 Rev A 100 127 VAC Figure 4 Label 4 Follow instructions for use MLS 1000005 Rev D Figure 5 Label 5 High voltage caution MLS1000...

Page 32: ...sk of Explosion MLS1000009 Rev B Figure 9 Label 9 Single use cryoprobe various options of shapes tip length and sizes For Example MLP7100100 MLP7200100 A B C Figure 10 Label 10 For illustration only C...

Page 33: ...ense Confidential User Manual 33 Return to first page U S User Manual Figure 11 Label 11 Single use temperature sensor MLT8000101 Rev A Figure 12 Label 12 Liquid nitrogen Dewar MLS1000001 Rev E Figure...

Page 34: ...dential User Manual 34 Return to first page U S User Manual Figure 14 Label 14 Cold area MLS1000010 Rev B Figure 15 Label 15 Empty LN2 Dewars MLS1000012 Rev A Figure 16 Label 16 Applied parts MLS10000...

Page 35: ...ential User Manual 35 Return to first page U S User Manual Figure 18 Label 18 Shipping Art Work MLS3080002 Rev A Figure 19 Label 19 Shipping Art Work UCG1000025 Figure 20 Label 20 Only IceCure technic...

Page 36: ...MLC9000100 MLC9100100 Rev A 2 10 1 Important Symbols and Labels A number of internationally recognized symbols relating to safety requirements and standards are found on the ProSense cryoablation syst...

Page 37: ...collected and disposed of separately Never dispose of electrical and electronic components in general municipal waste receptacles Electrical and electronic equipment contain hazardous substances which...

Page 38: ...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...

Page 39: ...US Federal law restricts this device to sale by or on the order of a physician Mandatory conformity mark for electronic products placed on the market in the USA Restriction of Hazardous Substances co...

Page 40: ...parts Operational 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 surgi...

Page 41: ...nitrogen 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...

Page 42: ...chassis are two hooks used for hanging the electric cable and a grip handle for ease of system transportation Figure 23 The ProSense transportation rollers brakes 3 3 2 Emergency Stop button The Emerg...

Page 43: ...handle or hose The hose shouldn t be bent or flexed especially during 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...

Page 44: ...r Manual Figure 26 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 27 The User Manual Table of contents Yo...

Page 45: ...eceived from your 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 rea...

Page 46: ...ngle use 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 i...

Page 47: ...tabilizes the hose 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...

Page 48: ...g to clinical 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...

Page 49: ...temperature 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...

Page 50: ...he system from one location to another the Dewars must be empty 3 4 Operational details This section describes the operational actions of the ProSense cryoablation system that support the functional o...

Page 51: ...he system Before turning on the system confirm the following conditions Previously used cryoprobe temperature sensors and sleeves have been removed and the system has been cleaned of any residue and d...

Page 52: ...ablation 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 and mo...

Page 53: ...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 Dewars s...

Page 54: ...sis 4 3 2 For countries in which local line voltage is 220 240 VAC The ProSense cryoablation system is pre wired for the local line voltage as specified by the user Accordingly the unit will require a...

Page 55: ...ar Hand pump for immediate pressure Cryo Gloves Mid arm length large waterproof pair Face shield up to LN2 protection 4 5 Installation Warning The ProSense cryoablation system must be unpacked install...

Page 56: ...e applications 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 thu...

Page 57: ...on 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 the patient...

Page 58: ...surgery or superficial 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...

Page 59: ...s displayed on the screen with a blue circle icon Figure 44 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...

Page 60: ...option from the Main Menu screen Choosing the Settings button see no 1 will load the settings screen with four icons representing different options Pressing any of these icons will open a new settings...

Page 61: ...chnician Mode entry screen that is used for maintenance of the system The technician mode can only be accessed by an IceCure Medical authorized technician and is restricted by a password Warning Never...

Page 62: ...vable storage device in an easy and convenient way When you press the Export Log icon a popup window appears with the following message Connect a USB flash drive and press OK Press OK to export the lo...

Page 63: ...rt the system Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure 5 2 6 Preparing the system for treatment The system will guide the user through a...

Page 64: ...he system for treatment by pressing Prepare for Treatment no 1 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...

Page 65: ...stored with liquid nitrogen inside the system at the end of the working day For proper handling in order to ensure safety please follow the cryogen supplier instructions Warning Liquid nitrogen may c...

Page 66: ...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 Warning At the beginning of the proce...

Page 67: ...position 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 55 Correct insertion and positioning of the Dewar b...

Page 68: ...n it tries to move the Dewar carriage up or down the following popup message will appear Dewar door is open Close the door to continue Figure 58 Dewar door open warning 5 2 6 2 Sterile sleeves After f...

Page 69: ...trocar or pencil or blunt Always monitor the ice ball growth with adequate imaging techniques If an introducer to guide the cryoprobes to the tissue location is used make sure to choose an introducer...

Page 70: ...gth 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 The ice front of the ice ball v...

Page 71: ...t of the ice ball visible under imaging is around 3 C Ice ball isotherms of ProSense cryoprobe from experiments in gel at room temperature 3 4 Cryoprobe Elliptic ice ball shape FAP7200000 FAP7400000 F...

Page 72: ...ue outline including the tumor and the safety margins to be treated Example 1 Cryoprobe 3 4 elliptic shape FAP7200000 Cool zone center of cryoprobe 3 4 elliptic 20 mm Lesion size 15 mm in its largest...

Page 73: ...n 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 figure below Figure 61 The cryoprobe the figure is for ill...

Page 74: ...istration screen Figure 63 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...

Page 75: ...rtion point in the handle as shown on screen and screw it until a NEXT button appears on screen then confirm screwing by an additional slight rotation to confirm that cryoprobe connection is secured R...

Page 76: ...igure 66 Cryoprobe reading failed Used cryoprobe warning message appears if a used cryoprobe is connected Replace the cryoprobe and press OK to continue Figure 67 Cryoprobe already used Expired cryopr...

Page 77: ...single use sterile sleeve are removed and safely discarded Warning Before beginning treatment of a patient you MUST ensure that the previous single use cryoprobe and sterile sleeve have been removed...

Page 78: ...s Make sure the tip is pointed in a safe direction 5 If the cryoprobe cannot be screwed out of the cryohandle the system should not be turned on before disengaging the cryoprobe from the cryohandle 6...

Page 79: ...Please record the error number and follow system instructions until you are requested to remove the cryoprobe safely from the cryohandle You will then be returned to the Main Menu screen Contact IceCu...

Page 80: ...frost on the plastic cover near the cryohandle foam or any unusual appearance and it is not represented by one of the Illustrations press CANCEL Follow system instructions until you are required to s...

Page 81: ...e hurt by the sharp cryoprobe being ejected under pressure In addition the hose and the cryoprobe still contain liquid nitrogen that can be spilled out if you disengage the cryoprobe before you get pr...

Page 82: ...procedure screen will open After inserting the cryoprobe into the tissue you will be able to start the cryoablation procedure 5 2 7 2 Define treatment protocols ProSense cryoablation system allows you...

Page 83: ...ProSense Confidential User Manual 83 Return to first page U S User Manual Figure 73 Define a treatment protocol by choosing Setup Presets on the Treatment Selection screen see no 1 Figure 74 Edit Pres...

Page 84: ...slots in 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...

Page 85: ...IceCure Medical Ltd DSR3200000 rev G ProSense Confidential User Manual 85 Return to first page U S User Manual Figure 76 Steps for adding a protocol...

Page 86: ...DIT PRESET screen will load The process 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 cryother...

Page 87: ...uring the procedure Skin protection techniques include but are not limited to dripping room temperature sterile saline on these areas continuous monitoring of the growing ice ball by ultrasound or CT...

Page 88: ...mm skin incision for example using 11 blade Position the tip of the cryoprobe minimally 4 mm beyond the distal edge of the long axis of the target tissue 3 When an introducer to guide the Cryoprobes...

Page 89: ...ollow these steps is essential for maintaining sterility and patient safety First insert the cryoprobe tip into the target tissue Be aware of the markings on the cryoprobe the wide mark closest to the...

Page 90: ...rning You must NOT allow the freeze process to start before the cryoprobe active area is actually within the target tissue The practitioner can hold the cryohandle for the duration of the cryoablation...

Page 91: ...t the ice ball size The physician should always 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 M...

Page 92: ...and a blue active progress line The FREEZE icon will change to a THAW icon and will allow you to move from freeze cycle to THAW cycle by pressing the THAW icon or the Action button on the cryohandle...

Page 93: ...r EXTRACTION cycle and time elapsed for this specific step The right side of the screen displays information on the entire Protocol as total elapsed time and treatment format If you perform more than...

Page 94: ...th each push At the end of the last freeze step in automatic mode the EXTRACTION step will begin and the EXTRACTION screen will be displayed You can move from the automatic mode AT ANY TIME by pressin...

Page 95: ...preprogrammed protocol 5 3 5 THAW During THAW the ice ball melts partially or totally depending on the THAW time and the tissue properties It is clinically important to have a THAW cycle between two...

Page 96: ...displayed on screen informing the user that the EXTRACTION cycle is done for example 40 50 seconds for 2 cm ice ball Wait for the message then gently remove the cryoprobe from the target tissue and t...

Page 97: ...to disengage the cryoprobe In case the EXTRACTION process isn t available wait for passive THAW Figure 88 The EXTRACTION screen during procedure At the end of the EXTRACTION cycle unless you press FIN...

Page 98: ...ryoprobe 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 of the cryoprobe from the tissue as it m...

Page 99: ...ual Figure 91 The Passive THAW screen For an additional freeze cycle press the RELOCATE icon and select a treatment cycle To end procedure press FINISH Figure 92 Completed screen without Extraction op...

Page 100: ...R3200000 rev G ProSense Confidential User Manual 100 Return to first page U S User Manual Figure 93 Treatment selection screen during relocate Figure 94 Dewar Replacement screen Figure 95 Dewar Replac...

Page 101: ...e wait shows up 5 3 7 Show Last Treatment The last treatment will be displayed by choosing SHOW LAST TREATMENT icon on the Main Menu screen In this screen you can see details of the last procedure tha...

Page 102: ...refill should be done between any two freezes if the first FREEZE duration is greater or equal 5 minutes and the total freeze duration planned for both FREEZE procedures is greater or equal 10 minute...

Page 103: ...re the end of the THAW cycle Figure 100 Lowering the Dewar during THAW screen The message Please wait Do not open the door yet will show up The system will perform several steps and then it will infor...

Page 104: ...figure below Figure 102 The replacement done follow up screen When preparation of the new Dewar is complete the system will come back to the THAW cycle figure below To go to the NEXT freeze cycle you...

Page 105: ...system can t continue to Freeze It will ask to 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 co...

Page 106: ...age U S User Manual If you press CANCEL you will get a message of Low Nitrogen See a figure below Figure 106 Procedure stopped due to Low Nitrogen If you press OK you will get an Extraction Completed...

Page 107: ...e temperature sensor from the tissue make sure the freeze effect has been deactivated and the sensor can be easily withdrawn Never use excessive force to extract the temperature sensor 5 4 2 Removing...

Page 108: ...er arm 5 4 4 Disassembling the temperature sensor If a temperature sensor was used pull the gray part of the cable connector backwards to release it and then pull the cable connector away from the fro...

Page 109: ...y Switch 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...

Page 110: ...error 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...

Page 111: ...he electrical 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 H...

Page 112: ...Y 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 pressing the emergency...

Page 113: ...ressing 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...

Page 114: ...bottom corner 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 C...

Page 115: ...pears the 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...

Page 116: ...m 10G 140 mm Trocar 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...

Page 117: ...cer lumen to improve heat exchange between the cryoprobe and the tissue if too big Introducer was chosen Warning Cryoprobe introducer temperature sensor and holder materials are not compatible with ma...

Page 118: ...ion 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 patient body a...

Page 119: ...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 it is recommended to wipe the h...

Page 120: ...in single use packaging The sleeves are used to cover the hose up to the cryoprobe 8 3 Periodic servicing Caution The ProSense cryoablation system is not user serviceable Refer all service issues to...

Page 121: ...U S User Manual Figure 119 Counter of the remaining procedure before maintenance see no 1 at the bottom of the main menu screen Caution The system will not allow additional treatment when zero proced...

Page 122: ...oting guide Problem Probable Cause Action Main chassis does not move Wheels are locked Unlock the wheels transport the system and lock them again If the problem persists contact IceCure Medical servic...

Page 123: ...l service Dewar is empty pop up during freeze cycle while Dewar is NOT empty Machine or Cryoprobe blockage The machine will alert of Dewar is empty and elevator will descent This is proper machine fun...

Page 124: ...k side of the system 8 If required wait for the Dewar to be lowered down and perform a new procedure with full Dewar and a new cryoprobe while maintaining sterility System provides Used Cryoprobe mess...

Page 125: ...process malfunction Do not use force in attempting to remove the cryoprobe from the tissue Wait a few minutes and try removing it gently again If problem persists contact IceCure Medical service Cryo...

Page 126: ...ystem off If the interference is still observed Re orient or relocate the other device s Increase the separation between the equipment Connect the system into an outlet on a circuit different from tha...

Page 127: ...he 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 You can modify the c...

Page 128: ...0 psi Cryogen 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 15...

Page 129: ...reasonably 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 w...

Page 130: ...e Medical Ltd DSR3200000 rev G ProSense Confidential User Manual 130 Return to first page U S User Manual 13 CUSTOMER COMPLAINT FORM Section 1 Customer complaint To be filled by customer complaint rec...

Page 131: ...ORT CUSTOMER COMPLAINT Send to IceCure Medical Inc 41 18 Christine Ct Fair Lawn NJ 07410 USA icecuresupport icecure medical com support icecure medical com Tel 1 646 844 3066 OR IceCure Medical Ltd Ha...

Page 132: ...Stocks LH Simmons R Schultz M Cryoablation of early stage breast cancer work in progress report of a multi institutional trial Ann Surg Oncol 2004 May 11 5 542 9 10 Simmons RM Ballman KV Cox C Carp N...

Page 133: ...noperable stage I non small cell lung cancer PLoS One 2012 7 3 e33223 23 Inoue M Nakatsuka S Yashiro H Ito N Izumi Y Yamauchi Y Hashimoto K Asakura K Tsukada N Kawamura M Nomori H Kuribayashi S Percut...

Page 134: ...osenthal D Callstrom M R 2012 Critical Review and State 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...

Page 135: ...agnetic 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...

Page 136: ...d is the 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 fr...

Page 137: ...uipment 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 Separat...

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