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IceCure DSR3200000 User Manual

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User Manual
DSR3200000 rev. G
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.
IceCure Medical, Inc.
41-18 Christine Ct
Fair Lawn
NJ, 07410, USA
icecuresupport@icecure-medical.com
Tel: +1-646-844-3066
The information in this document is confidential and is intended only for use of the recipient. Unauthorized
use, duplication, publication or disclosure is strictly prohibited. If you have received this document in error,
please notify IceCure Medical immediately.
IceCure Medical Ltd.
nd
7 Haeshel St., 2
floor, P.O.B 3163
Caesarea 3079504, Israel
info@icecure-medical.com
Tel: +972-4-623 0333
Fax: +972-4-623 0222
1

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  • Page 1 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. IceCure Medical, Inc. IceCure Medical Ltd.

  • Page 2: Table Of Contents

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Contents OVERVIEW ........................8 Introduction ......................8 Intended use ......................8 Indications for use ....................9 ProSense™ Qualified users ................... 10 Clinical decisions ....................10 Contraindications ....................11 Qualified technician ....................
  • Page 3 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 3.3.3 Flexible hose ....................43 3.3.4 Touch screen and User Manual activation ............. 43 3.3.5 Cryohandle and cryoprobe ................45 Holder – Optional (Not available in some regions, e.g. China) ..... 47 3.3.6...
  • Page 4 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual ProSense™ cryoablation system touch screen failure ......... 111 5.6.2 COMPUTER INTERFACE ..................113 The technician menu ................... 113 Reading the screen ....................113 System messages ....................114 6.3.1 Status messages ....................
  • Page 5 Figure 18: Label 18- Shipping Art Work MLS3080002 Rev. A ......... 35 Figure 19: Label 19- Shipping Art Work UCG1000025 ............. 35 Figure 20: Label 20- Only IceCure technician is authorized to open the crate MLS1000013 Rev. A ..........................35 Figure 21: Label 21- Single use Introducers (various options of length and sizes) For Example: MLC9000100, MLC9100100 Rev.
  • Page 6 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 55: Correct insertion and positioning of the Dewar – bottom first – Make sure it’s positioned freely in the base .................. 67 Figure 56: Insertion of the Dewar – Head First – might cause wrong positioning of Dewar leaning forward ........................
  • Page 7 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 99: Replace Dewar option question ................ 102 Figure 100: Lowering the Dewar during THAW screen........... 103 Figure 101: The replace Dewar screen and press ok to continue ........103 Figure 102: The replacement done follow up screen ............

  • Page 8: Overview

    1.2 Intended use The IceCure Family device, including the ProSense cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. The IceCure Family device, including the ProSense cryoablation...

  • Page 9: Indications For Use

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 1.3 Indications for use The system may be used with an imaging device like ultrasound device to provide real- time visualization of the cryosurgical procedure. The system has the following specific indications: Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH)).

  • Page 10: Prosense™ Qualified Users

    If you do not meet the above criteria, do not use the 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 personnel.

  • Page 11: Contraindications

    There are no known contraindications specific to the use of IceCure’s cryoablation systems and its’ accessories: Cryoprobes, Introducers and Temperature Sensor. 1.7 Qualified technician Only a technician trained by IceCure Medical is qualified to service the ProSense™ cryoablation system. Servicing includes periodic maintenance and repair of the system according to requirements.

  • Page 12: Safety Notes

    Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide. Any malfunction not listed in the guide, or one that persists after the recommended action has been taken, must be referred to IceCure Medical Return to first page U.S User Manual...

  • 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

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 2.2.5 Clinical Assessment Warning 2.2.6 Practitioners should be aware of the possibility of imaging findings at the site of a cryoablated area. Practitioners should inquire if a patient has a history of cryoablation.
  • Page 15 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 cryoprobe can easily be removed from the tissue.

  • Page 19: Operating Warnings

    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. 2.3 Operating warnings Warning Ensure that the cryoprobe is securely connected.
  • Page 20 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Do not force removal of the cryoprobe from the tissue as it might increase the risk of tissue damage. Continue the EXTRACTION step or wait for passive THAW until the cryoprobe can be withdrawn easily.

  • Page 21: Liquid Nitrogen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Warning Pay attention to the probe during pre-test: bubbles, leak or frost on shaft may signal internal problems that could be hazardous. Warning If you don’t press SKIP after replacing Dewar, the system will stay in THAW mode.

  • Page 22: Opening The Dewar Compartment

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 2.4.2 Opening the Dewar compartment Caution Never open the Dewar compartment while running a cryoablation procedure. Do not use the system while the Dewar compartment is open. Warning Do not transfer a Dewar containing Liquid nitrogen unless it is covered with its designated lid.
  • Page 23 Confidential User Manual 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. Warning If there is not sufficient ventilation in the room, the ProSense™™...

  • 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: Grounding

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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. If unwanted freezing occurs, stop the pre-test process by pressing "Cancel".

  • Page 26: Mechanical Handling Of Hose And Cryohandle

    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 27: Emergencies Causing Procedure Halt

    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 28: Disposal

    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 29: Compliance

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Contact your local authority or place of purchase regarding responsible disposal/recycling. Dispose of the Cryoprobe, Temperature-Sensor and Cryohandle sleeve in accordance with institutional policy. Do not reuse; do not re-sterilize.

  • Page 30: Figure 1: Label 1 On/Off Mechanical Button - Mls1000002 Rev. B

    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 – 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 31: Figure 3: Label 3 - Identification - Mls3080104 Rev. A (220-240 Vac) Mls3080103 Rev. A (100 - 127 Vac)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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 - MLS1000006 Rev.

  • Page 32: Figure 8: Label 8 - Risk Of Explosion - Mls1000009 Rev. B

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev. B Figure 9: Label 9 - Single use cryoprobe (various options of shapes, tip, length and sizes) – For Example: MLP7100100, MLP7200100.

  • Page 33: Figure 11: Label 11 - Single Use Temperature Sensor Mlt8000101 Rev. A

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 11: Label 11 - Single use temperature sensor MLT8000101 Rev. A Figure 12: Label 12 - Liquid nitrogen Dewar - MLS1000001 Rev. E Figure 13: Label 13 - Black Dewar - MLS1000015 Rev. B Return to first page U.S User Manual...

  • Page 34: Figure 14: Label 14 - Cold Area - Mls1000010 Rev. B

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential 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 - MLS1000014 Rev. A Figure 17: Label 17- Holder –...

  • Page 35: Figure 18: Label 18- Shipping Art Work Mls3080002 Rev. A

    Figure 18: Label 18- Shipping Art Work MLS3080002 Rev. A Figure 19: Label 19- Shipping Art Work UCG1000025 Figure 20: Label 20- Only IceCure technician is authorized to open the crate MLS1000013 Rev. A Return to first page U.S User Manual...

  • Page 36: Important Symbols And Labels

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 21: Label 21- Single use Introducers (various options of length and sizes) For Example: 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™...
  • Page 37 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Symbol Meaning 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 38 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Symbol Meaning Do not use if package is damaged Cold area Consult instructions for use Oxygen depleting This side up Authorized representative in the European community CE mark- mandatory conformity mark for products placed...
  • Page 39 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Symbol Meaning Keep away from sunlight Keep dry CAUTION: US Federal law restricts this device to sale by or on the order of a physician Mandatory conformity mark for electronic products...

  • Page 40: System Description

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 3 SYSTEM DESCRIPTION 3.1 Introduction This chapter contains the following: • Concept of operation – ProSense™ cryoablation system intention for use • Major components – description of the main system parts •...

  • Page 41: Major Components

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 3.3 Major components The following figure illustrates external features of the cryoablation system: Touch screen Cryoprobe cradle Cryohandle Temperature sensor connector Emergency button Rollers Dewar positioning Figure 22: Front and back view of the ProSense™ cryoablation system...

  • Page 42: Main Chassis

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential 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.

  • Page 43: 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 44: Figure 26: The User Manual Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User 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.

  • Page 45: Cryohandle And Cryoprobe

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 28: The User Manual screen By pressing on the x (right corner), you will exit the User Manual. If you prefer, you can also download the User Manual from our website: http://www.icecure-medical.com...

  • Page 46: Figure 30: The 90 Degrees Cryohandle (No 1) And Connected Cryoprobe (No 2)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 30: 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 47: Holder - Optional (Not Available In Some Regions, E.g. China)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 32: The Cryohandle closed with the plug on the Handle 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 48: Foot Pedal (Not Available In Some Regions, E.g. China)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 49: Figure 36: The Temperature Sensor And Its Components

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual The temperature sensor and its components are depicted in the following figure. Figure 36: 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 50: Dewar Storage Cases

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Warning Temperature sensor and cryoprobe 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 51: Starting The System

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • Care must be taken when filling the system dewar. • Standard guidelines for safe handling and storage of liquid nitrogen should be followed. These guidelines are available from the supplier.

  • Page 52: System Pre-Tests

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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. Additional specific tests will be made upon visual inspection by the user, following instructions on the graphic interface.

  • Page 53: Installation And Setup

    Caution The ProSense™ cryoablation system must be unpacked, installed, and tested by an IceCure Medical authorized technician only. Caution After positioning the main chassis, lock the front roller brakes. Failure to do so may result in damage to the system or to other equipment in the clinic room.

  • Page 54: Electrical Requirements

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 4.3 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.

  • Page 55: 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 56: Operating The System

    MR safe and should not be used in MRI procedures. 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 57: Preparing The Patient For Procedure

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 5.2.2 Preparing the patient for procedure 1. Always position the patient in a comfortable way. 2. If you use a Hose-holder, position patient comfortably on the holder base so that the target area is easily accessible and trajectory of the cryoprobe is safe (make sure that Holder adjustable arm is not in the way of the user).

  • Page 58: Switching On The Prosense™ Cryoablation System

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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.

  • Page 59: Cryohandle

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 43: The Main Menu screen 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.

  • Page 60: Figure 46: Activating The Settings Option From The Main Menu Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 46: Activating the Settings 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 screen pertaining to that option.

  • Page 61: Figure 48: Language Selection Screen

    The technician mode can only be accessed by an IceCure Medical authorized technician and is restricted by a password. 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.

  • Page 62: Figure 50: Export Log Screen

    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. 5.2.5.3 Export Log This screen allows you to export any procedure data to a USB removable storage device in an easy and convenient way.

  • Page 63: Preparing The System For Treatment

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 51: 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. In order to complete the process, restart the system.

  • Page 64: Figure 52: Preparing The System For Treatment By Pressing Prepare For Treatment (No. 1) On Main Menu Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual To prepare the system for treatment, choose the option Prepare for Treatment in the Main Menu as shown in the below figure. Figure 52: Preparing the system for treatment by pressing Prepare for Treatment (no. 1) on Main Menu screen 5.2.6.1 Dewar...

  • Page 65: Figure 54: Frost On The Dewar Border

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 54: Frost on the Dewar border Be aware that frost on the Dewar border may result in a lower performance because of pressure leakage from the Dewar.
  • Page 66 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 67: Figure 55: Correct Insertion And Positioning Of The Dewar - Bottom First - Make Sure It's

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 55: Correct insertion and positioning of the Dewar – bottom first – Make sure it’s positioned freely in the base Figure 56: Insertion of the Dewar – Head First – might cause wrong positioning of Dewar leaning forward Figure 57: Insertion of the Dewar Bottom First –...

  • Page 68: Figure 58: Dewar Door Open Warning

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 69 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 70 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 71: Figure 59: Ice Ball Isotherms Of Prosense™ Cryoprobe From Experiments In Gel At Room Temperature

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual ** Ice ball isotherms of ProSense™ cryoprobe from experiments in gel at room temperature. 3.4 Cryoprobe Spheric (ice ball shape) (FAP7100000) Ice Ball Dimensions at Various Temperatures over Time -3°C*...
  • Page 72 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 5.2.6.4 Cryoprobe positioning The cryoprobe 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 73: Figure 60: Pre-Planning Trajectory Needle Insertion

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 60: 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 74: Figure 62: Cryoprobe Registration Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 62: Cryoprobe registration 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 cryoprobe S/N registration will result in cryoprobe nullification.

  • Page 75: Figure 64 : "Peel Here" Label

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 5.2.6.6 Cryoprobe connection Connect the cryoprobe to the cryohandle as follows, while maintaining sterility of the cryoprobe: • Open the cryoprobe pouch in accordance to the “PEEL HERE” label •...

  • Page 76: Figure 66: Cryoprobe Reading Failed

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 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 •...

  • Page 77: Figure 68: Cryoprobe Expired

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 68: Cryoprobe expired 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.
  • Page 78 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 3. Do not grasp cryoprobes with auxiliary instruments as this may cause damage to the cryoprobe shaft. 5.2.6.7 Handling Cryoprobe Mechanical Failure During any phase of the procedure, if the cryoprobe is identified to have any mechanical damage, please follow the instructions below: 1.

  • Page 79: Figure 69: Wait For Functional Test Screen

    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 IceCure Medical technical service. After successful internal test, the system will display the visual inspection screen.

  • Page 80: Figure 71: Functional Test - Visual Inspection Screens

    Dewar is full and replace the cryoprobe. 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 81: Treatment Selection

    • You will then be returned to the Main Menu screen. Check that the Dewar is full and replace the cryoprobe and start again. If the problem recurs do not proceed with treatment. Turn OFF the system and contact IceCure Medical. • Choosing SUCCESS will load the treatment selection screen.

  • Page 82: Figure 72: Treatment Selection Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Type of treatment is determined by the number and duration of freeze and THAW cycles, and depends also on the practitioner’s preferred way of work. Figure 72: Treatment Selection screen 5.2.7.1 Automatic freeze mode...

  • Page 83: Figure 73: Define A Treatment Protocol By Choosing Setup Presets On The Treatment Selection Screen (See No 1)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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) Return to first page U.S User Manual...

  • Page 84: Figure 75: Editing An Existing Protocol (See No 1) Or Adding A New One (See No 2)

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 85: Figure 76: Steps For Adding A Protocol

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

  • Page 86: Figure 77: Edit Preset Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 87: Operational Stages

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 78: Choosing the Manual Mode option (see no 1) 5.3 Operational stages 5.3.1 Safe Operation in Percutaneous Procedures When performing percutaneous cryotherapy procedures, meticulous observation of the incision site and the skin overlying the treatment site is required.
  • Page 88 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual You must NOT allow the freeze process to start before the cryoprobe active area is actually within the target tissue. Warning Cryoprobe, introducer, temperature sensor and holder materials are not...

  • Page 89: Freeze Cycle

    Fit to needle diameter 10G Trocar FAC9200000 (FAP7400000 and FAP7410000) *IceCure Medical systems, needles, introducers, cryoprobes 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 90: Pause Option

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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. If unwanted freezing occurs, immediately stop the freezing process.

  • Page 91: Figure 81: Pause (No 1) And Play (No 2) Buttons During The Freeze Cycle

    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 92: Figure 82: Manual Mode Screen: Press On Freeze To Start The Freeze Cycle

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 82: Manual Mode screen: press on Freeze to start the freeze cycle. 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 93: Figure 85: Extraction Screen In Manual Mode

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • Pressing the button on the straight handle (optional) will start the Warming process and will initiate the end of the procedure. • When the Extraction is done, you may try to extract the cryoprobe from the tissue.

  • Page 94: Figure 86: Automatic Mode Screen: Press On Start To Begin The Freeze Cycle

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • The skip icon enables the user to skip from the current step in the cycle to the next step as preprogrammed. • Within a given protocol, if you want to increase/decrease the preprogrammed time of a cycle when the cycle has already started, use the +/- icons on the left side of the screen to add/subtract 15 seconds with each push.

  • Page 95: Thaw

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 96 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual In order to be able to get the EXTRACTION option, the freeze time should have been at least 2 minutes. If you did not previously freeze for 2 minutes, the system may update you to wait for a passive thawing process (fig.

  • Page 97: Figure 88: The Extraction Screen During Procedure

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • The system will then perform several verification steps and it will inform you when it is safe to disengage the cryoprobe. • In case the EXTRACTION process isn’t available, wait for passive THAW.

  • Page 98: Figure 90: Completed Screen With 3 Options: Extraction, Relocate And Finish

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 90: Completed screen with 3 options: Extraction, Relocate and Finish. To continue the warming - press the Extraction icon. For an additional freeze cycle - press the RELOCATE icon and select a treatment cycle.

  • Page 99: Figure 91: The Passive Thaw Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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 option...

  • Page 100: Figure 93: Treatment Selection Screen During Relocate

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 93: Treatment selection screen during relocate Figure 94: Dewar Replacement screen Figure 95: Dewar Replacement finished screen Return to first page U.S User Manual...

  • Page 101: Show Last Treatment

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 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 The last treatment will be displayed by choosing SHOW LAST TREATMENT icon on the Main Menu screen.

  • Page 102: Replace (Refill) The Dewar During A Cryoprocedure

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 98: Last Treatment screen after up to 3 freeze cycles 5.3.8 Replace (refill) the Dewar during a cryoprocedure Option to refill the Dewar is available at each THAW cycle.

  • Page 103: Figure 100: Lowering The Dewar During Thaw Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • If you press OK you will get the "Please wait… Do not open the door yet!" message meaning that the system is lowering the Dewar (see figure below).

  • Page 104: Figure 102: The Replacement Done Follow Up Screen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual • After pressing the OK button, the system will proceed and prepare the new Dewar that was inserted. The screen will show "Proceeding, please wait… " (figure below) Figure 102: The replacement done follow up screen •...

  • Page 105: Figure 104: Replacement Was Completed After The Thaw Ended

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Figure 104: Replacement was completed after the THAW ended 5.3.8.1 Replace the Dewar during Freeze 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 106: Figure 106: Procedure Stopped Due To Low Nitrogen

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential 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 screen" with 3 options: Extraction, Relocate and Finish.

  • Page 107: Post-Operational Stages

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 108: Disassembling The Support Device - Hose-Holder

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Dispose of the cryoprobe, temperature sensor and cryohandle sleeve in accordance with institutional policy. Do not reuse, do not re-sterilize. 5.4.3 Disassembling the support device - Hose-Holder If a Hose-Holder accessory is used as a support device, safely disengage the hose from the Holder arm.

  • Page 109: Instruct Patients

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 110: System Failures

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 5.6 System failures 5.6.1 ProSense™ cryoablation system failure When the ProSense™ cryoablation system detects an error, the following will occur: • A failure message will appear. • The procedure will be aborted.

  • Page 111: 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 112 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 113: 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 114: System Messages

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 115: 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 116: Accessories

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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: Cryoprobe Diameter/...

  • Page 117: The Foot Pedal

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Select the cryoprobe based on ice ball size you want to obtain and the cooling zone location as defined in the table above. Always monitor the ice ball engulfment with appropriate imaging modality.

  • Page 118: The Holder

    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 119: System Maintenance

    Caution Do not in any way, clean the labels’ area with Acetone (Holder and IceCure systems). Check the main unit for any remaining blood or tissue. In case these remnants are detected, wipe the infected area with gauze pads soaked with 70% alcohol.

  • Page 120: 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 121: Figure 119: Counter Of The Remaining Procedure Before Maintenance (See No 1) At The

    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 procedures are left to maintenance. Make sure to call IceCure Medical service representatives in time. Return to first page U.S User Manual...

  • Page 122: 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 123 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 Cryoprobe blockage The machine will alert of “Dewar is up during freeze cycle empty”...
  • Page 124 Make sure cryoprobe is secured failed” message and press ok to retry reading. If displayed on the screen. the message reappears, change the cryoprobe and call IceCure Medical service. FREEZE/EXTRACTION Faulty icon or operator misuse. Try pushing the icon again. It is...
  • Page 125 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Problem Probable Cause Action Ice formation on the Low temperature and long This is not an operational problem. hose, the cryohandle freezing cycles may cause Wipe OFF accumulated ice with and sterile sleeve moisture to form ice particles.
  • Page 126 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Problem Probable Cause Action working/ Controller is the back of the system or stuck emergency stop. Then turn ON the system (after releasing the emergency stop button, if pressed) and wait for computer re-boot.

  • Page 127: Prosense™ Cryoablation System - Step-By-Step Procedure

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 128: System Specifications

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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...

  • Page 129: Limited Warranty Certificate

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G 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 130: Customer Complaint Form

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 13 CUSTOMER COMPLAINT FORM Section 1: Customer complaint (To be filled by customer / complaint recipient) Return to first page U.S User Manual...

  • Page 131: Report Customer Complaint

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 14 REPORT 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 IceCure Medical Ltd. Haeshel 7, 2 floor, P.O.B 3163, Caesarea 3079504, Israel support@icecure-medical.com...

  • Page 132: Cryoablation Clinical References

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 15 Cryoablation Clinical References 1. Berger, W., & Poledna, J. (2001). New strategies for the placement of cryoprobes in malignant tumors of the liver for reducing the probability of recurrences after hepatic cryosurgery.
  • Page 133 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 16. R. Houston Thompson a,*, Tom Atwell b, Grant Schmit b, Christine M. Lohse c, A. Nicholas Kurup b,Adam Weisbrod b, Sarah P. Psutka a, Suzanne B. Stewart a, Matthew R.
  • Page 134 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual primary hepatocellular carcinomas of >2 cm compared with radiofrequency ablation and microwave coagulation therapy: an underestimated tool in the toolbox., Ann Surg Oncol. 2015 Apr;22(4):1294-300. Epub 2014 Oct 7., Ann Surg Oncol. 2015 33.

  • Page 135: Manufacturer's Declaration Of The Eut

    ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual 16 Manufacturer’s Declaration of the EUT Guidance and manufacturer’s declaration-electromagnetic emission- for all 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.
  • Page 136 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Guidance and manufacturer’s declaration-electromagnetic immunity- for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration-electromagnetic immunity The model ProSense™ Cryotherapy product is intended for use in the electromagnetic environment specified below.
  • Page 137 ™ ™ IceCure Medical Ltd. DSR3200000 rev. G ProSense Confidential User Manual Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM- for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the model ProSense™...

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