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IceCure

™

 Medical Ltd. 

DSR3200000 rev. G      

 ProSense

™

  

Confidential 

 

User Manual  

 

 

27 

 Return to first page                                                                                                        U.S User Manual  

2.5.2

 

Emergencies causing procedure halt 

 

Warning 

When a procedure halts due to an error, switch OFF 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 is displayed and a procedure is aborted, remove the 
cryoprobe ONLY after you are allowed to do so by the system. Failure to do 
so will increase the risk of a liquid nitrogen related accident.

 

 

 

 

Warning 

In case of software crash, switch OFF the mechanical ON/OFF button and 
unplug the electrical cable.  

Call IceCure Medical for technical service before restarting the ProSense™ 

cryoablation system. 
 

 

 

 

Warning 

When the system shuts 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. After 
reporting or making note of the error message, switch OFF the mechanical 
ON/OFF button and unplug the electrical cable. 

 

 

2.6

 

Adverse events 

Frostbite  are  known  adverse  events  related  to  the  specific  use  of  the  Cryoablation 
cryoprobes.  There  are,  however,  potential  adverse  events  associated  with  any  surgical 
procedure. Potential adverse events which may be associated with the use of cryoablation 
may  be  organ  specific  or  general  and  may  include,  but  are  not  limited  to  myocardial 
infraction, 

abscess, 

adjacent 

organ 

injury, 

allergic/anaphylactoid 

reaction, 

angina/coronary  ischemia,  arrhythmia,  atelectasis,  bladder  neck  contracture,  bladder 
spasms,  bleeding/hemorrhage,  creation  of  false  urethral  passage,  creatinine  elevation, 
cystitis,  diarrhea,  death,  delayed/non  healing,  disseminated  intravascular  coagulation 
(DIC), deep vein thrombosis (DVT), ecchymosis, edema/swelling, ejaculatory dysfunction, 
erectile  dysfunction  (organic  impotence),  fever,  fistula,  hematoma,  hematuria, 
hypertension,  hypotension,  hypothermia,  idiosyncratic  reaction,  ileus,  impotence, 

Содержание DSR3200000

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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