Page 1 User Manual DSR3210000 rev. D Please read this document carefully before using the ProSense™ cryoablation system. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your IceCure Medical representative.
Page 2: Table Of Contents
Contents OVERVIEW ........................8 Introduction ......................8 Intended use ......................8 Indications for use ....................8 ProSense™ Qualified users ................... 10 Clinical decisions ....................10 Qualified technician ....................11 Advanced Operator ....................11 SAFETY NOTES ......................12 Warnings and cautions ..................12 Basic safety principles ...................
Page 3 Removing the cryoprobe from the cryohandle ..........104 5.4.3 Disassembling the support device - Hose-Holder ........105 5.4.4 Disassembling the temperature sensor ............105 Exiting the ProSense™ cryoablation system treatment mode ..... 105 5.4.5 Instruct patients: ....................106 System failures ....................107 Return to first page...
Page 4 Periodic servicing ....................117 TROUBLESHOOTING ..................... 119 General ........................ 119 Troubleshooting guide ..................120 10 ProSense™ cryoablation system - Step-by-Step procedure ........124 11 SYSTEM SPECIFICATIONS ................... 125 12 LIMITED WARRANTY CERTIFICATE ..............126 13 CUSTOMER COMPLAINT FORM ................. 127 14 REPORT CUSTOMER COMPLAINT ..............
Page 5 Figure 17: Label 17- Shipping Art Work MLS3080002 Rev. A ......... 33 Figure 18: Label 18- Shipping Art Work UCG1000025 ............. 33 Figure 19: Label 19- Only IceCure technician is authorized to open the crate MLS1000013 Rev. A ..........................34 Figure 20: Front and back view of the ProSense™...
Page 6 Confidential User Manual Figure 56: Dewar door open warning .................. 66 Figure 57: Ice ball isotherms of ProSense™ cryoprobe from experiments in gel at room temperature.......................... 69 Figure 58: Pre-Planning trajectory needle insertion ............71 Figure 59: The cryoprobe (the figure is for illustration only) ..........71 Figure 60: Cryoprobe registration screen ................
Page 7 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 102: Replacement during Freeze, in case of empty Dewar........102 Figure 103: Procedure stopped due to Low Nitrogen............103 Figure 104: EXTRACTION Completed screen..............103 Figure 105: Safe to Remove probe ..................104 Figure 106: Protocol Completed screen.
Page 8: Overview
1.3 Indications for use ProSense™ cryoablation system is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology as detailed below. The ProSense™ cryoablation system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Page 9 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Oncology • The system may be used for ablation of cancerous or malignant tissue. • The system may be used for ablation of benign and malignant breast tumors • The system may be used for ablation of benign and malignant lung tumors •...
Page 10: Prosense™ Qualified Users
The ProSense™ cryoablation system is indicated for patients whom the surgeon has designated as eligible for cryotherapy. 1.4 ProSense™ Qualified users You are a qualified ProSense™ cryoablation system user only if you meet all of the following criteria:  You are a board certified medical practitioner licensed in your country.
Page 11: Qualified Technician
 You have read and understood all relevant material accompanying the ProSense™ cryoablation system. Warning If you do not meet the above criteria, do not use the ProSense™ cryoablation system for presentation or other marketing use. Return to first page...
Page 12: Safety Notes
User Manual 2 SAFETY NOTES While this manual is designed to provide instructions in the use of the ProSense™ cryoablation system, it is not intended to take the place of the user training course which must be completed before using the system.
Page 13: Training
Warning Never open the console. Only an IceCure Medical technician or authorized representative is allowed to open the console for maintenance or to repair the system.
Page 14: Clinical Assessment
Physicians should exercise caution when using the cryoablation system in pregnant women. Warning The handle and hose portions of the ProSense™ cryoablation system may become cold during the cryoablation procedure. Operators should consider insulating these parts in order to prevent discomfort to the patient.
Page 15 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning Do not rely solely on the temperature sensor measurement. Always monitor the procedure using Ultrasound or other appropriate imaging systems. Caution Artifacts from the devices may appear in the Ultrasound or CT image.
Page 16: Installation And Setup
Caution The ProSense™ cryoablation system must be unpacked, installed, and tested by an IceCure Medical authorized technician only. Caution There are no user-serviceable parts in the system. Refer all service issues to IceCure Medical’s Customer Service Department.
Page 17: Proper Use
Caution Dewars should always be stored with their lids in place. Caution Only Dewars and lids supplied by IceCure Medical may be used with the ProSense™ cryoablation system. Make sure to use only an approved IceCure Dewar for your system.
Page 18 Follow the detailed instructions on opening the Dewar storage- when you want to replace a Dewar. Caution The system will not allow additional treatment when zero procedures are left to maintenance. Make sure to call IceCure Medical service representatives in time. Return to first page...
Page 19: Operating Warnings
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 Medical. Warning The probe must be IN THE TARGET TISSUE BEFORE starting the freeze treatment.
Page 20 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning DO NOT push the EXTRACTION button when the cryoprobe is not within the target 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.
Page 21: Liquid Nitrogen
ANY flammable material. ProSense™ cryoablation system should be kept away from flammable fumes, e.g., flammable anesthetics or volatile substances. An easily accessible fire extinguisher in the vicinity of the unit is recommended.
Page 22: Voltage And Power Ratings
Return the Dewar to an IceCure-Medical technician or an authorized distributor for inspection. Warning If there is not sufficient ventilation in the room, the ProSense™™ cryoablation system cannot be used due to risk of suffocation due to increased levels of nitrogen in the room.
Page 23 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual object that has been in contact with liquid nitrogen. Loose fitting gloves are recommended so that 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 tucked into boots, but worn outside.
Page 24: Burn Hazards
Do not use a liquid nitrogen Dewar if it is damaged. You can tell that a Dewar is damaged if after filling it, frost appears on the outer wall of the container. Return the Dewar to an IceCure-Medical technician or an authorized distributor for inspection.
Page 25: Sterility
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 the cryohandle or hose. The hose should be bent gently during procedure.
Page 26: Emergencies And Errors
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.
Page 27: Adverse Events
Warning Regulatory requirements mandate that serious adverse events be reported to the relevant regulatory authorities. Users must notify IceCure Medical of all serious adverse events, including serious adverse device reactions, no later than 24 hours following receipt of such information.
Page 28: Equipment Classification
Label 17- Shipping Art Work Label 18- Shipping Art Work UCG1000025 Label 19- Only IceCure Medical technician is authorized to open the crate Label 20 – Single use Introducers (various options of length and sizes) There are additional labels inside the system that are not visible to the user. These labels are intended for the technician.
Page 29: Figure 1: Label 1 On/Off Mechanical Button - Mls1000002 Rev. B
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual System Labels: Figure 1: Label 1 ON/OFF mechanical button - MLS1000002 Rev. B Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B Figure 3: Label 3 - Identification - MLS3180001 Rev. E (220-240 VAC) MLS3080003 Rev.
Page 30: Figure 5: Label 5 - High Voltage Caution - Mls1000006 Rev. B
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 5: Label 5 - High voltage caution - MLS1000006 Rev. B Figure 6: Label 6 - Line voltage danger - MLS1000007 Rev. B Figure 7: Label 7 - Foot pedal - MLS1000008 Rev. B Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev.
Page 31: Figure 9: Label 9 - Single Use Probe (Various Options Of Shapes, Tip, Length And Sizes)
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 9: Label 9 - Single use probe (various options of shapes, tip, length and sizes) - MLP7000001 Rev. J Figure 10: Label 10 - Single use temperature sensor MLT8000001 Rev. H Figure 11: Label 11 - Liquid nitrogen Dewar - MLS1000001 Rev.
Page 32: Figure 12: Label 12 - Black Dewar - Mls1000015 Rev. B
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 12: Label 12 - Black Dewar - MLS1000015 Rev. B Figure 13: Label 13 – Cold area - MLS1000010 Rev. B Figure 14: Label 14- Empty LN2 Dewars - MLS1000012 Rev. A Figure 15: Label 15- Applied parts - MLS1000014 Rev.
Page 33: Figure 16: Label 16- Holder - Mlg1000006 Rev. B
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 16: Label 16- Holder – MLG1000006 Rev. B Figure 17: Label 17- Shipping Art Work MLS3080002 Rev. A Figure 18: Label 18- Shipping Art Work UCG1000025 Return to first page...
Page 34: Important Symbols And Labels
Confidential User Manual Figure 19: Label 19- Only IceCure technician is authorized to open the crate MLS1000013 Rev. A Figure 20: Label 20- Single use Introducers (various options of length and sizes) MLC9000002 Rev. C 2.10.1 Important Symbols and Labels A number of internationally recognized symbols relating to safety requirements and standards are found on the ProSense™...
Page 35 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Symbol Meaning Manufacturer Date of manufacture Do not reuse Use- by Date Catalogue number Do not resterilize Sterilized using ethylene oxide Batch code Contains sufficient for <n> test The WEEE symbol indicates that this system contains electrical and electronic components that must be collected and disposed of separately.
Page 36 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Symbol Meaning Fragile, handle with care Do not use if package is damaged Cold area Consult instructions for use Oxygen depleting This side up Authorized representative in the European community...
Page 37 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Symbol Meaning Transportation and storage humidity limits Storage temperature limits Keep away from sunlight Keep dry CAUTION: US Federal law restricts this device to sale by or on the order of a physician...
Page 38: System Description
• 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 surgical procedures. It is indicated for use as a cryosurgical tool in a number of medical fields.
Page 39: Major Components
Cryoprobe cradle Cryohandle Temperature sensor connector Emergency button Rollers Dewar positioning Figure 21: Front and back view of the ProSense™ cryoablation system door/Elevator door with numbered components Handle plug holder Foot pedal connector Foot pedal (Not available in some regions, e.g. China) ON-OFF switch The ProSense™...
Page 40: Main Chassis
User Manual 3.3.1 Main chassis The ProSense™ cryoablation system is housed within a chassis mounted ON 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 cryohandle cradle.
Page 41: Flexible Hose
It is designed for users and technicians. Do not connect any signal input/output port to the touch panel PC except certified equipment provided by IceCure Medical. A sample touch screen display is represented by the figure below. For further information about computer interface and operating the system, see Chapter 6.
Page 42: Figure 24: The User Manual Screen
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 25: The User Manual screen You can choose the part you want to read from the Table of Contents: click on it, and you will access it directly. Figure 26: The User Manual Table of contents...
Page 43: Cryohandle And Cryoprobe
The cryohandle is situated at the end of the hose that projects through the upper area of the 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.
Page 44: Figure 28: The 90 Degrees Cryohandle (No 1) And Connected Cryoprobe (No 2)
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 29: The 90 degrees cryohandle (No 1) and connected Cryoprobe (No 2) Warning Never reuse a single-use cryoprobe, temperature sensor or sterile sleeve. Warning At the conclusion of each patient session, remove and safely discard the single-use cryoprobe, temperature sensor and sterile sleeve.
Page 45: Holder - Optional (Not Available In Some Regions, E.g. China)
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 31: The Cryohandle on the Handle plug holder When using a 90 degrees cryohandle, pay attention that the cryohandle is directed towards the system when laid down on the handle plug holder on main chassis.
Page 46: Foot Pedal (Not Available In Some Regions, E.g. China)
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 3.3.7 Foot pedal (Not available in some regions, e.g. China) Pushing the pneumatic foot pedal is identical to activating/deactivating the freeze cycle and confirming actions displayed on the screen with blue circle icon:...
Page 47: Figure 34: The Temperature Sensor And Its Components
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual The temperature sensor and its components are depicted in the following figure. Figure 35: The temperature sensor and its components If you decide to use a temperature sensor, connect it per the following instructions while maintaining sterility: 1.
Page 48: Dewar Storage Cases
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning Temperature sensor and probe insertion and navigation within tissue MUST be done under guidance of an appropriate imaging device. 3.3.9 Dewar storage cases The Dewar storage shelves are located at the back of the chassis, providing storage for the Dewars.
Page 49: Operational Details
When moving the 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 operations described in Chapter 5. • Order liquid nitrogen in advance based on projected case load.
Page 50: System Pre-Tests
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 40: The system is loading screen Wait for the Main Menu screen to load. Figure 41: The Main Menu screen 3.4.2 System pre-tests As the system uploads, several internal built-in tests are performed automatically in order to verify that the system is safe for use.
Page 51: Cryoablation Procedure
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 3.4.3 Cryoablation procedure The 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 and monitored by the computer).
Page 52: Installation And Setup
4.2 Setup warnings and cautions Warning If there is not sufficient ventilation in the room, the ProSense™ cryoablation system cannot be used due to risk of suffocation due to increased levels of nitrogen in the room. Caution The ProSense™...
Page 53: Electrical Requirements
4.3.1 For countries in which local line voltage is 100-127 VAC The ProSense™ cryoablation system is pre-wired for the local line voltage as specified by the user. Accordingly, the unit will require a line supply of 100-127 VAC, 50/60 Hz, 12A single phase.
Page 54: Installation
Warning The ProSense™ cryoablation system must be unpacked, installed, and tested by an IceCure Medical authorized technician only and in accordance with the unpacking instructions manual. Any damage to the container or to the unit discovered upon unpacking, installing, or testing should be immediately reported to your cryoablation system distributor.
Page 55: Operating The System
TRAINING: Practitioners electing to be cryoablation system users must attend a training course prior to using the system. The course is taught by IceCure Medical certified personnel. 5.1 Procedure Overview •...
Page 56: Preparing The Patient For Procedure
Figure 42 : Schematic illustration of placement of the system and patient. Warning The handle and hose portions of the ProSense™ cryoablation system may become cold during the cryoablation procedure. Operators should consider insulating these parts in order to prevent discomfort to the patient.
Page 57: Switching On The Prosense™ Cryoablation System
ProSense™ Confidential User Manual 5.2.3 Switching on the ProSense™ cryoablation system Before operating the system, make sure the following conditions are in place: • Ultrasound or other appropriate imaging system is available for monitoring the medical procedure. In case of open surgery or superficial cryotherapy, no external imaging device is required.
Page 58: Cryohandle
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.4 Cryohandle The cryohandle allows the user to easily and safely handle the cryoprobe. The cryohandle parts are detailed in Chapter 3 - System description. The hose can be safely put on the adjustable Holder arm once positioning of the Cryoprobe is completed.
Page 59: Figure 45: The Settings Screen
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 technician and is restricted by a password. Return to first page...
Page 60: Figure 47:Technician Mode Screen
DSR3210000 rev. D ProSense™ Confidential User Manual Warning Never enter the Technician mode screen. Only an IceCure Medical technician or authorized representative is allowed to use the technician mode for maintenance or repair of the system. Backspace Hyphen Figure 50:Technician Mode screen Warning Never enter the Technician mode screen.
Page 61: Figure 48: Export Log Screen
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 51: Export Log screen 5.2.5.4 Set time This screen allows you to set the date and time. Figure 52: The Windows™ Date and Time Properties screen Set the date and time according to your time zone and approve it by clicking “Apply” in the right lower corner of the window.
Page 62: Preparing The System For Treatment
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.6 Preparing the system for treatment The system will guide the user through a system preparation process; following the system instructions is essential. Preparation includes technical steps and tests to make sure the system is ready for a cryotherapy procedure.
Page 63: Figure 52: Frost On The Dewar Border
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual The upper line is the maximum level of liquid nitrogen that should be filled and the lower line is the minimum level of liquid nitrogen that should be filled. Do not overfill the Dewar.
Page 64 Do not use a liquid nitrogen Dewar if it is damaged. You can tell that a Dewar is damaged if after filling it, frost appears on the outer wall of the container. Return the Dewar to an IceCure Medical technician or an authorized distributor for inspection.
Page 65: Figure 53: Correct Insertion And Positioning Of The Dewar - Bottom First - Make Sure It's Positioned Freely In The Base
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 56: Correct insertion and positioning of the Dewar – bottom first – Make sure it’s positioned freely in the base Figure 57: Insertion of the Dewar – Head First – might cause wrong positioning of Dewar leaning forward Figure 58: Insertion of the Dewar Bottom First –...
Page 66 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Dewar door is open If the system detects that the Dewar compartment door is open when it tries to move the Dewar carriage up or down, the following popup message will appear: Dewar door is open.
Page 67 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.6.3 Cryoprobe Selection Select a cryoprobe according to your clinical judgment and target tissue. The ice ball size is a function of the freezing time and is also affected by the tissue and blood flow (bench test on fig 58, Ice ball isotherms in gel at room temperature).
Page 68 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Ice ball measurement ranges are based on bench testing done at room temperature gel. Isotherm measurements in soft tissue tumors may vary depending on clinical application. Times and sizes are approximate and should not preclude clinical judgment.
Page 69 Length (minutes) (mm) (mm) (mm) (mm) (mm) (mm) *The ice front of the ice ball visible under imaging is around -3°C. Figure 60: Ice ball isotherms of ProSense™ cryoprobe from experiments in gel at room temperature. Return to first page...
Page 70 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.6.4 Probe positioning The probe specification defines the distance from 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.
Page 71 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual • Pre-plan your trajectory needle insertion and the needle point of entry prior to the treatment on baseline tumor measurements. Figure 61: Pre-Planning trajectory needle insertion 5.2.6.5 Cryoprobe registration Identify the cryoprobe serial number (S/N). It appears on the cryoprobe package and/or on screen and/or cryoprobe plastic grip as shown in the figure below.
Page 72 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 63: Cryoprobe registration screen Figure 64: Invalid serial number warning Caution Verify cryoprobe S/N registration by double checking the serial number on the package and on the cryoprobe itself. Entering an incorrect cryoprobe S/N registration will result in probe nullification.
Page 73 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.6.6 Cryoprobe connection Connect the cryoprobe to the cryohandle as follows, while maintaining sterility of the probe: • Remove the plug that covers the probe connection point. • Insert the cryoprobe into the insertion 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 probe connection is secured.
Page 74 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual • Used probe warning message appears if a used probe is connected. Replace the probe and press OK to continue. Figure 67: Cryoprobe already used • Expired probe warning message appears if an expired probe is connected. Replace the probe and press OK to continue.
Page 75 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning Never reuse a single-use cryoprobe, temperature sensor or a single-use sterile sleeve. Warning Never “unscrew” the cryoprobe if you are not clearly instructed to unscrew or disengage 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.
Page 76 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.6.7 System test Perform a functional test to ensure system efficacy and safety per the following instructions and per the screens presented in the figures below: • Prepare a container full of sterile water/saline.
Page 77 Please record the error number and follow system instructions until you are requested to remove the probe 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 display the visual inspection screen.
Page 78 Dewar is full and replace the probe. If the problem recurs, do not proceed with treatment. Turn OFF the system and contact IceCure Medical. • If a functional problem occurs as represented by one of the on-screen images, press on the relevant image.
Page 79: Treatment Selection
5.2.7.2 Define treatment protocol s ProSense™ cryoablation system allows you to define specific treatment protocols by pressing the SETUP PRESETS icon at the bottom of the Treatment Selection screen. Additional option to define treatment protocol is available before “system test” by using EDIT PRESETS in the Main Menu screen (As shown in the figure below).
Page 80 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 73: Define a treatment protocol by choosing Setup Presets on the Treatment Selection screen (see no 1) Figure 74: Edit Presets in the Main Menu screen (see no 2)
Page 81 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.7.3 Adding a protocol If you choose to add a protocol, press one of the empty slots in the screen: the EDIT PRESET screen will load. Please follow the NEXT steps: 1.
Page 82 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 76: Steps for adding a protocol Return to first page...
Page 83 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.2.7.4 Editing a protocol If you choose to edit an existing protocol (See figure 72, no 1), the EDIT PRESET screen will load. The process is very similar to that of adding a new protocol.
Page 84: Operational Stages
5.3.2 Preliminaries Before operating ProSense™ cryoablation system, make sure you have completed all pre- operational stages. Warning...
Page 85 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 3. When an introducer 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 create an air barrier...
Page 86 Fit to needle diameter 13G (FAP7820000) Trocar FAC9300000 *IceCure Medical systems, needles, introducers, probes and accessories may not be available in all regions. Figure 79: Introducer shaft length The order in which you follow these steps is essential for maintaining sterility and patient safety.
Page 87: Freeze Cycle
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.3.3 Freeze Cycle Selecting the type of treatment, Manual or Automatic, is discussed in section 5.3.4.1 and 5.3.4.2. Warning Portions of the cryoprobe other than the freeze zone, including the plastic cover that is located near the cryoprobe handle, may become cold and cause tissue damage.
Page 88 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 Manual freeze mode will open the treatment screen for manual mode as show in Fig.
Page 89 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 83: Freeze screen in Manual Mode • The progress of the freeze cycle will be shown on the screen with a second counter and a blue active progress line.
Page 90 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual • You can continue to move between cycles using the same method. • To end the procedure, and retract the probe, press the EXTRACTION icon on the screen. Freezing will cease and the warming will be activated.
Page 91 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual left lower corner of the screen. The BLUE LED will light up around the Action button. • The START icon will change to a SKIP icon. • The skip icon enables the user to skip from the current step in the cycle to the next step as preprogrammed.
Page 92: Thaw
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 87: Freeze screen in Automatic mode During the preprogrammed procedure, the system provides information regarding treatment progress: • The left side of the screen displays the Current Step (freeze, THAW, or EXTRACTION cycle) and time left for this cycle.
Page 93 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual If you did not previously freeze for 2 minutes, the system may update you to wait for a passive thawing process (fig. 85) before you can extract the probe. • To activate the EXTRACTION, press on the RED button on the straight cryohandle or the EXTRACTION icon on screen as previously shown.
Page 94 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual At the end of the EXTRACTION cycle, unless you press FINISH, one of the two screens below will be displayed automatically: Extraction Figure 89: The Extraction screen The Extract screen appears for a few seconds and is replaced automatically by the ‘Completed’...
Page 95 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning After Extraction step, before removing the cryoprobe from the tissue, make sure that the freeze effect has been deactivated so that the probe can easily be removed from the tissue.
Page 96 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 92: Completed screen without Extraction option In case Relocate is pressed, the Treatment selection screen appears and the dewar needs to be refilled: Figure 93: Treatment selection screen during relocate...
Page 97: Show Last Treatment
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 94: Dewar Replacement screen Figure 95: Dewar Replacement finished screen After each relocate screen, replace Dewar when required and follow instruction for freeze cycle. The message " Please wait…" shows 5.3.7 Show Last Treatment...
Page 98 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 96: Last Treatment screen after relocation Figure 97: Last Treatment screen after more than 3 freeze cycles without relocation. Figure 98: Last Treatment screen after up to 3 freeze cycles...
Page 99: Replace (Refill) The Dewar During A Cryoprocedure
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.3.8 Replace (refill) the Dewar during a cryoprocedure Option to refill the Dewar is available at each THAW cycle. In case you intend to do a long treatment that will freeze over 7 minutes in each one of the freeze cycles, refill the Dewar during the THAW time of the procedure.
Page 100 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 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 inform you that it is safe to replace the Dewar and you will get the Replace Dewar screen (figure below).
Page 101 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 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 have to press SKIP – even if the time to complete the replacement exceeded the preset THAW time (figure below).
Page 102 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 104: Replacement was completed after the THAW ended 5.3.8.1 Replace the Dewar during Freez e In case of low Nitrogen, the system can’t continue to Freeze. It will ask to refill the Dewar in Freeze cycle (see fig.
Page 103 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 106: Procedure stopped due to Low Nitrogen. If you press OK, you will get an "Extraction Completed screen" with 3 options: Extraction, Relocate and Finish. Figure 107: EXTRACTION Completed screen.
Page 104: Post-Operational Stages
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 5.4 Post-operational stages 5.4.1 Removing the temperature sensor from 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 minutes, since the temperature sensor can be surrounded by ice.
Page 105: Disassembling The Support Device - Hose-Holder
5.4.5 Exiting the ProSense™ cryoablation system treatment mode At the 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.
Page 106: Instruct Patients
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Figure 110: The Main Menu screen. To shut down the system, press on the Shutdown icon (see no 1). Figure 111: The System Shutdown screen. Press “OK” to proceed (see no 2).
Page 107: System Failures
3. Detach the cryoprobe from the cryohandle ONLY after the system instructs you that it is safe to do so. 4. If system shut down is required, shut OFF the ProSense™ cryoablation system by pressing the mechanical ON/OFF button ON the main chassis and then remove the plug from the power supply.
Page 108: Prosense™ Cryoablation System Touch Screen Failure
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. 5.6.2.1 Emergency Stop button The fastest way to end a procedure is to press the RED HANDLE button or EXTRACT on the screen.
Page 109 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Warning If an electrical hazard is detected at any time, PUSH the Emergency Stop button immediately. Caution Push the Emergency Stop button ONLY when there is NO other choice. Wherever possible, the system should be shut down by the standard procedure.
Page 110: Computer Interface
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.
Page 111: System Messages
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 6.3 System messages Messages can appear in one of three modes: status, warning or error messages. 6.3.1 Status messages Information that is valuable to the user will appear in the status bar area at the bottom of the screen.
Page 112: Error Messages
Figure 117: Error message format example 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.
Page 113: Accessories
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 7 ACCESSORIES 7.1 Cryoprobe 7.1.1 Single use sterile cryoprobe Figure 118: The cryoprobe components (the figure is for illustration only) There are various cryoprobe configurations. For example: * These probes should be handled with care and with plausible force.
Page 114: The Foot Pedal (Not Available In Some Regions, E.g. China)
Confidential User Manual The ProSense™ cryoprobes are available in various diameters (2 mm to 3.4mm), various ice ball shapes (Spheric, Ellipsoid), various tips (trocar, blunt and pencil) and various lengths according to the expected application, treated tumor size and surgery approach.
Page 115: The Holder (Not Available In Some Regions, E.g. China)
Holder gripper and tighten the locks. 7.5 Shelf life Expiration date of all IceCure sterile accessories are specified by the appropriate labels on the external package as well as on the internal package. Return to first page...
Page 116: System Maintenance
Thoroughly clean the ProSense™ cryoablation system unit with a damp cloth and warm soapy water. Dry it with a clean cloth. Clean the monitor screen with a soft cloth and a mild window cleaning solution.
Page 117: Sterility
The sterile sleeves and covers are single-use and are not supplied by IceCure Medical in single use packaging. The sleeves are used to cover the hose up to the cryoprobe 8.3 Periodic servicing...
Page 118 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Caution The system will not allow additional treatment when zero procedures are left to maintenance. Make sure to call IceCure Medical service representatives in time. Return to first page...
Page 119: Troubleshooting
9.1 General Warning Do not modify this equipment without authorization of the manufacturer. Warning Never open the console. Only an IceCure Medical technician or authorized representative is allowed to open the console for maintenance or to repair the system. Warning Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide.
Page 120: Troubleshooting Guide
Dewar is not in place or is blocked If Dewar cannot be removed, close cannot be removed. by an unknown object. the door, and contact IceCure Medical service. “Dewar is empty” pop- Machine or Probe blockage The machine will alert of “Dewar is up during freeze cycle empty”...
Page 121 Burned out LED, or it should not Check user manual to verity that be lighting up at given time. the LED should light up. If yes, contact IceCure Medical service. Ice formation on the Low temperature and long This is not an operational problem.
Page 122 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Problem Probable Cause Action If problem persists, contact IceCure Medical service. Cryoprobe is difficult to Parts are frozen together Try again after five minutes. If it detach from cryohandle. still cannot be detached, contact IceCure Medical service.
Page 123 IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual Problem Probable Cause Action click “O.K” when the message pops up, but to wait until the message disappear by itself. In case you clicked “O.K” the screen freeze till the end of the “long wash”...
Page 124: Prosense™ Cryoablation System - Step-By-Step Procedure
DSR3210000 rev. D ProSense™ Confidential User Manual 10 ProSense™ cryoablation system - Step-by-Step procedure Before starting the procedure, a Pre-Test must be carried out! System preparation and Pre-Test 1. Press Prepare for treatment. 2. Remove the Dewar’s cap and fill the Dewar with liquid nitrogen in a safe manner.
Page 125: System Specifications
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 11 SYSTEM SPECIFICATIONS Physical properties Dimensions (excluding the Height: 120 cm (47.24 inches) screen) Depth: 70 cm (27.56 inches) Width: 50 cm (19.68 inches) Weight 150kg Electrical requirements 100-127 VAC...
Page 126: Limited Warranty Certificate
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 12 LIMITED WARRANTY CERTIFICATE Terms and conditions for warranty of purchased medical equipment. Warranty Number: __________ Date of Issue: __________ We, as sellers of the equipment, warrant that for a period ending twelve (12) months from the date of supply of the equipment as stated below, the equipment shall be free from defects in material and workmanship.
Page 127: Customer Complaint Form
IceCure Medical Ltd. DSR3210000 rev. D ProSense™ Confidential User Manual 13 CUSTOMER COMPLAINT FORM Section 1: Customer complaint (To be filled by customer / complaint recipient) Return to first page...
Page 128: Report Customer Complaint
Southern Industrial Park, Caesarea 38900, Israel support@icecure-medical.com Tel: +972-4-623 0333 Fax: +972-4-623 0222 MedNet GmbH – Authorized Representative of IceCure Medical Ltd. Borkstraße 10 48163 Münster Germany Tel +49 (0) 251 32266-0 Fax +49 (0) 251 32266-22 Return to first page...
Page 129: Manufacturer's Declaration Of The Eut
EQUIPMENT AND SYSTEMS 1 Guidance and manufacturer’s declaration-electromagnetic emission 2 The model ProSense™ Cryotherapy product is intended for use in the electromagnetic environment specified below. The customer or the user of the model ProSense™ Cryotherapy product should ensure that it is used in such an environment.
Page 130 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model ProSense™ Cryotherapy product is used exceeds the applicable RF compliance level above, The model ProSense™ Cryotherapy product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model ProSense™...
Page 131 The model ProSense™ Cryotherapy product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model ProSense™ Cryotherapy product can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the model ProSense™...

IceCure ProSense User Manual

1 Overview

2 Safety Notes

3 System Description

4 Installation and Setup

5 Operating the System

6 Computer Interface

7 Accessories

8 System Maintenance

9 Troubleshooting

10 Prosense™ Cryoablation System - Step-By-Step Procedure

11 System Specifications

12 Limited Warranty Certificate

13 Customer Complaint Form

14 Report Customer Complaint

15 Manufacturer's Declaration of the EUT

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