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IceCure ProSense FAS3100000 User Manual

Cryoablation system
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User Manual
DMS-7064 rev. C
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.
icecuresupport@icecure-medical.com
US/Canada Toll Free 1-888-902-5716
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.
Cryoablation System
IceCure™ Medical Ltd.
7 Haeshel St., 2
Caesarea 3079504, Israel
info@icecure-medical.com
Tel: +972-4-623 0333
Fax: +972-4-623 0222
nd
floor, P.O.B 3163
1

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Summary of Contents for IceCure ProSense FAS3100000

  • Page 1 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. IceCure™ Medical Ltd.

  • Page 2: Table Of Contents

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Table of Contents OVERVIEW ......................8 Introduction ....................... 8 Intended use ......................8 Indications for use ...................... 8 ProSense™ Qualified users ..................10 Clinical decisions ...................... 10 Contraindications ..................... 10 Qualified technician ....................
  • Page 3 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Dermatology: ......................29 General predictable adverse events when using the introducers ......30 Disposal ........................30 Compliance ....................... 30 Compliance with international safety standards ............. 30 Equipment classification ..................30 Accompanying labels ....................
  • Page 4 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Safe Operation in Percutaneous Procedures ............86 Preliminaries ......................86 Freeze Step ....................... 89 Thaw ......................... 94 Extraction ......................... 94 Show Last Treatment ....................99 Replace (refill) the Dewar during a cryoablation procedure ......... 100 Post-operational stages ..................
  • Page 5 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual List of Figures Figure 1: ON/OFF Switch label ..................... 32 Figure 2: Emergency Stop button label ................32 Figure 3: System Identification labels .................. 32 Figure 4: ProSense™ straight handle Identification labels ..........33 Figure 5: Follow Instructions for Use ...................
  • Page 6 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 41 : Schematic illustration of placement of the system and patient....... 57 Figure 42: System is loading screen ..................58 Figure 43: Main Menu screen ....................59 Figure 44: Action button as displayed on screen (several of the options) ......59 Figure 45: Extraction button as displayed on screen ............
  • Page 7 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 85: Thaw screen in Manual Mode ................91 Figure 86: Extraction screen in Manual Mode..............92 Figure 87: Automatic Mode screen: press on Start to begin the Freeze step..... 93 Figure 88: Freeze screen in Automatic mode ..............

  • Page 8: Overview

    Introduction ProSense™ Cryoablation System is a comprehensive system for cryotherapy of human tissue based on IceCure™ Medical’s technology. All established cryotherapy techniques utilize a low temperature cryogen under pressure. The ProSense™ Cryoablation System utilizes liquid nitrogen that causes the cryoprobe to reach very low temperatures thereby freezing tissue with which it comes in contact.
  • Page 9 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • The system may be used for ablation of benign and malignant lung tumors • The system may be used for ablation of benign and malignant musculoskeletal tumors • The system may be used for ablation of benign and malignant liver tumors •...

  • 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: Advanced Operator

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Servicing includes periodic maintenance and repair of the system according to requirements. Warning Do not modify this equipment without authorization of the manufacturer Advanced Operator You are a qualified ProSense™ cryoablation system ‘Advanced Operator’ only if you meet all of the following criteria: ...

  • Page 12: Safety Notes

    Any malfunction not listed in the guide, or one that persists after the recommended action has been taken, must be referred to IceCure™ Medical Warning Never allow untrained personnel to operate the ProSense™ cryoablation system.

  • Page 13: Training

    Do not use this system if there is any instruction, direction, precaution or note which you do not understand or which is unclear. Never hesitate to contact an authorized IceCure™ Medical representative for further information and clarification before using the system.
  • Page 14 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning Safety and effectiveness of the ProSense™ cryoablation system in pregnant women has not been established. Physicians should exercise caution when using the cryoablation system in pregnant women. Warning The cryohandle and hose portions of the ProSense™ cryoablation system may become cold during the cryoablation procedure.

  • Page 15: Voltage And Power Ratings

    Installation and Setup Caution The ProSense™ cryoablation system must be unpacked, installed, and tested by an IceCure™ Medical technician or by a technician authorized by IceCure™ Medical to perform installation and testing on ProSense™ system. Caution After positioning the main chassis, lock the front roller brakes. Failure to do so may result in damage to the system or to other equipment in the clinic room.
  • Page 16 Dewars should always be stored with their dedicated 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 17 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Caution If one or more of the rollers is damaged, do not use the system. Warning Cryoprobes are fragile and can be damaged if mishandled. Do not use a cryoprobe that has been bent, dropped, hit against a hard surface or compromised in any manner, as damage to the cryoprobe may have occurred.

  • Page 18: Cyber Security

    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. Warning The system and its accessories are not compatible with magnetic resonance imaging.

  • Page 19: Operating Warnings

    Insertion of the cryoprobe into the target tissue must be performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure™ Medical. Warning If the procedure is not yet underway after a cryoprobe is screwed onto the cryohandle, exercise caution to prevent a stabbing injury from the cryoprobe and maintain sterility of the cryohandle and cryoprobe.

  • Page 20: Liquid Nitrogen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning 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 or incomplete treatment.

  • Page 21: Danger - Explosion And Fire Hazard

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Danger - explosion and fire hazard Warning The ProSense™ cryoablation system includes electronic devices that may emit sparks, and therefore, should not be operated in the presence of flammable materials.
  • Page 22 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning Standard guidelines for safe handling and storage of liquid nitrogen are available from the supplier and must be carefully observed Warning Handle liquid nitrogen with care. Contact with skin may cause serious frostbite.
  • Page 23 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 24: Burn Hazards

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Burn hazards The Cryoprobe tip can reach very low temperatures. 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 25: Mechanical Handling Of Hose And Cryohandle

    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 26: Predictable Adverse Events

    Call IceCure™ Medical for technical service before restarting the ProSense™ cryoablation system. Warning When the system shuts itself down due to an error, contact IceCure™ Medical and describe the error message shown on the screen as precisely as possible. Do not attempt to reuse the system before contacting IceCure™...

  • Page 27: Anesthesia

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Severe adverse events: infection, thermal injury, procedure done on the wrong patient/ part of the body, retention of foreign object after surgery, pulmonary emboli, congestive heart failure, stroke, fall, severe changes in the laboratory parameters-elevation in...

  • Page 28: Laparoscopic Procedure

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Laparoscopic procedure • Mild/moderate adverse events: vascular and visceral injury, general anesthesia related AE, pneumoperitoneum (that can cause hemodynamic alterations), post procedural abdominal adhesions, abdominal wall hematoma, wound infection and fascial injury.

  • Page 29: Liver

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual emboli, Loss of speech (temporary aphasia from laryngeal nerve damage), arm paresis, burn, hemorrhage, pneumonitis. • Severe adverse events: respiratory failure/arrest, pneumothorax, hemothorax, pleural effusion, pneumonia, empyema, lung collapse, thrombosis, phrenic nerve palsy,...

  • Page 30: General Predictable Adverse Events When Using The Introducers

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual General predictable adverse events when using the introducers Trauma to tissue, incomplete treatment, infection, user accidental injury, needle seeding. Disposal The WEEE symbol indicates that this system contains electrical and electronic components that must be collected and disposed of separately.
  • Page 31 Shipping and storage conditions sticker Figure 19 UCG1000025 Shipping label Figure 20 MLS1000013 Crate opening restriction sticker: Only IceCure™ Figure 21 Medical technician is authorized to open the crate MLC9000100, Single use Introducer labels – various options of Figure 22 MLC9100100 length and size.

  • Page 32: Figure 1: On/Off Switch Label

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Note: Images of labels and stickers in this section are for reference only. Figure 1: ON/OFF Switch label Figure 2: Emergency Stop button label Figure 3: System Identification labels European User Manual...

  • Page 33: Figure 4: Prosense™ Straight Handle Identification Labels

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 4: ProSense™ straight handle Identification labels Figure 5: Follow Instructions for Use Figure 6: High Voltage Caution Figure 7: Label 6 - Line Voltage Danger Figure 8: Foot Pedal...

  • Page 34: Figure 9: Risk Of Explosion Label

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 9: Risk of Explosion label Figure 10: Single use cryoprobe label Figure 11: Color Tag Labels for Cryoprobes (A) and Introducers (B), and their location on the external box.

  • Page 35: Figure 12: Single Use Temperature Sensor Label

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 12: Single use temperature sensor label Figure 13: Liquid Nitrogen Dewar label Figure 14: Black Dewar label Figure 15: Cold area sticker Figure 16: Empty LN2 Dewars sticker European User Manual...

  • Page 36: Figure 17: Bf Applied Parts Symbol

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

  • Page 37: Important Symbols And Labels

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 20: Shipping label Figure 21: Crate Opening Restriction sticker Figure 22: Single use Introducer labels Important Symbols and Labels A number of harmonized symbols relating to safety requirements and standards are found on the ProSense™...
  • Page 38 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Symbol Meaning Caution/Warning Applied parts Serial number Manufacturer Date of manufacture Do not reuse Use- by Date Catalogue number Do not resterilize Sterilized using ethylene oxide Batch code Contains sufficient for <n> test...
  • Page 39 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Symbol Meaning The WEEE symbol indicates that this system contains electrical and electronic components that must be collected and disposed of separately. Never dispose of electrical and electronic components in general municipal waste receptacles.
  • Page 40 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Symbol Meaning Authorized representative in the European community CE mark- mandatory conformity mark for products placed on the market in the European Economic Area Transportation and storage atmospheric pressure limits...
  • Page 41 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Symbol Meaning Lock; tighten two parts together in a fixed position MR safety warning: system materials are not compatible with magnetic resonance imaging European User Manual...

  • Page 42: System Description

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual SYSTEM DESCRIPTION Introduction This chapter contains the following:  Concept of operation – ProSense™ cryoablation system intention for use  Major components – description of the main system parts  Operational details – system processes that occur as a result of user actions Concept of operation The ProSense™...

  • Page 43: Main Chassis

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual The ProSense™ Cryoablation system includes:  Main chassis  Adjustable touch screen  External accessories: introducers, temperature sensor, liquid nitrogen Dewar, Holder (Not available in some regions, e.g. China), foot pedal (Not available in some regions, e.g.

  • Page 44: 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 45: Figure 26: Touch Screen Display Before A Cryoablation Procedure

    For confidentiality and security reasons, the access is protected. Please use the Personal Password you received from your IceCure™ Medical representative. If you would like to acquire a printed copy of the User Manual, please contact us directly and one will be sent to you within 7 working days.

  • Page 46: Cryohandle And Cryoprobe

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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.

  • Page 47: Holder - Optional (Not Available In Some Regions, E.g. China)

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning Cryoprobes, temperature sensors, introducers, and sterile sleeves are single- use devices supplied in single use sterile packaging. Reprocessing single-use devices affects their performance and can cause cross-contamination. Warning After finishing the cryoablation procedure on a patient, remove and safely discard the single-use cryoprobe, temperature sensor, introducers, and sterile sleeve.

  • Page 48: Foot Pedal (Not Available In Some Regions, E.g. China)

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual The hose can be safely put on the Holder arm once positioning of the Cryoprobe in the tissue is completed. The Holder base is designed to be positioned under the patient body while the holder arm is adjustable at the side of the table.

  • Page 49: Figure 36: Temperature Sensor And Its Components

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual The temperature sensor is not indicated for measuring the body temperature, but only for getting temperature indication of some tissue during cryoablation. Warning Do not rely solely on the temperature sensor measurement. Always monitor the procedure using Ultrasound or other appropriate imaging systems.

  • Page 50: Dewar Storage Cases

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 37: Temperature display of sensor in the bottom-right corner of the screen Warning Temperature sensor, introducer, or cryoprobe insertion and navigation within a tissue must be done under guidance of an appropriate imaging device.

  • Page 51: Starting The System

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • Industrial grade liquid nitrogen should be delivered to the user’s site in a standard cryogenic Dewar. • Follow standard guidelines for the safe handling and storage of the Dewar.

  • Page 52: System Functional Tests

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 40: Main Menu screen System functional 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 or by technician authorized by IceCure Service Manager to perform installation and testing on ProSense™ system. Caution After positioning the main chassis, lock the front roller brakes.

  • Page 54: Electrical Requirements

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Electrical requirements 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, 12 A single phase.

  • Page 55: Installation

    Warning The ProSense™ cryoablation system must be unpacked, installed, and tested by an IceCure™ Medical technician or by a technician authorized by IceCure™ Medical to perform installation and testing on ProSense™ system. 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

    The device materials are not compatible with magnetic resonance imaging; thus, it is not 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. Procedure Overview •...

  • Page 57: Preparing The Patient For Procedure

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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 or CT gantry).

  • Page 58: Switching On The Prosense™ Cryoablation System

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual the ablated lesion will not contact or jeopardize the implant, and there is enough space to create the required margins. Switching on the ProSense™ cryoablation system Before operating the system, make sure the following conditions are in place: •...

  • Page 59: Cryohandle

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 43: Main Menu screen 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 60: General Settings

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual General settings The system general settings and technician mode are available by choosing the “Settings” button at the bottom of the touch screen. Figure 46: Activating the Settings option from the Main Menu screen Choosing the “Settings”...

  • Page 61: Figure 48: Language Selection Screen

    IceCure™ Medical authorized technician and is restricted by a password. Warning Never enter the Technician mode screen. Only an IceCure™ Medical technician is allowed to use the technician mode for maintenance or repair of the system. Figure 49:Technician Mode screen...

  • Page 62: Figure 50: Export Log Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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. When you press the Export Log icon, a popup window...

  • Page 63: Preparing The System For Treatment

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 5.2.5.4 Set time This screen allows you to set the date and time. Figure 51: Windows® Date and Time Properties screen Set the date and time according to your time zone and approve it by pressing OK. To complete the process, restart the system.

  • Page 64: Figure 52: Preparing The System For Treatment By Pressing Prepare For Treatment On Main

    IceCure™ Medical Ltd. DMS-7064 rev. C 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 on Main Menu screen 5.2.6.1 Dewar...

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

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 54: Frost on the Dewar opening Be aware that frost or ice on the Dewar opening may result in a lower performance because of pressure leakage from the Dewar. Safely wipe the Dewar opening of ice using a dry cloth before you insert it into the system.
  • 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 56: Correct Insertion And Positioning Of The Dewar - Bottom First

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 56: Correct insertion and positioning of the Dewar – bottom first Make sure the Dewar positioned freely in the base. Figure 57: Insertion of the Dewar – head first, leaning forward Such insertion might cause wrong positioning of the Dewar, leaning forward.

  • Page 68: Figure 59: Dewar Door Open Warning

    IceCure™ Medical Ltd. DMS-7064 rev. C 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: Figure 60: Ice Ball Measurement Ranges

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Always monitor the ice ball growth with adequate imaging techniques. If an introducer to guide the cryoprobes to the tissue location is used, make sure to choose an introducer with tight dimensions. The cryoablation may be affected by the use...
  • Page 70 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Table 2: 2.4 mm/13G Cryoprobe Spheric (ice ball shape) FAP7600000 Ice Ball Dimensions at Various Temperatures over Time -3°C* -20°C -40°C Time Width Length Width Length Width Length (minutes) (mm)

  • Page 71: Figure 61: Cryoprobe (The Figure Is For Illustration Only)

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Table 5: 3.4 mm/10G Cryoprobe Elliptic (ice ball shape) FAP7200000; FAP7410000; FAP7400000 Ice Ball Dimensions at Various Temperatures over Time -3°C* -20°C -40°C Time Width Length Width Length Width Length...

  • Page 72: Figure 62: Cryoprobe Registration Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C 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 or incomplete treatment.

  • Page 73: Figure 64 : "Peel Here" Label

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 5.2.6.5 Cryoprobe connection Connect the cryoprobe to the cryohandle as follows, while maintaining sterility of the cryoprobe: 1. Open the cryoprobe pouch in accordance to the “PEEL HERE” label Figure 64 : “PEEL HERE” label 2.

  • Page 74: Figure 65: Cryoprobe Connection Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 65: Cryoprobe connection screen 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 75 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning 1. While cryoprobe is in use, surgical instruments should be handled with care to avoid damage to the cryoprobe. 2. Avoid pinching, cutting or pulling the cryoprobe. Do not use damaged cryoprobes.
  • Page 76 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 5.2.6.6 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. Press the red emergency stop button.

  • Page 77: Figure 66: 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 78: Figure 68: Functional Test - Visual Inspection Screens

    You will then be returned to the Main Menu screen. To start again, check that the Dewar is full and replace the cryoprobe. If the problem recurs, do not proceed with treatment. Turn OFF the system and contact IceCure™ Medical.

  • Page 79: Cryoprobe Positioning

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning During functional test, portions of the cryoprobe other than the freeze zone, including the plastic cover that is located near the cryoprobe handle, may become cold due to malfunction. If unwanted freezing occurs, stop the pre -test process by pressing Cancel.

  • Page 80: Figure 69: Pre-Planning Trajectory Needle Insertion In Breast Applications

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Cool zone center of cryoprobe 2.4 elliptic = 14.5 mm Lesion size: 20 mm in its largest dimension Lesion shape: oval/elliptic 14.5 – (20/2) = 4.5 mm Correct placement of the cryoprobe inside the lesion requires that the tip goes beyond the lesion by 4.5 mm.

  • Page 81: Figure 71: Lesion Size Value

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 71: Lesion size value 3. Enter the Lesion size value in centimeters. After the Lesion size field is populated, the planned margin options are presented at the bottom of the screen.

  • Page 82: Treatment Selection

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 73: Calculated Result N/A Treatment Selection The system allows you to choose between manual mode and automatic mode using preset protocols. To choose automatic mode, select one of the preset protocols from the Treatment Selection screen as shown below.

  • Page 83: Figure 75: Edit Presets In The Main Menu Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 5.2.8.2 Define treatment protocols 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 84 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 5.2.8.3 Adding a protocol If you choose to add a protocol, press one of the empty slots in the screen: the Edit Presets screen will load. Perform the following steps: 1.

  • Page 85: Figure 77: Steps For Adding A Protocol

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 77: Steps for adding a protocol The calculated total time of all steps is displayed on the left pane of the screen. 5.2.8.4 Editing a protocol If you choose to edit an existing protocol (see Figure 76), the EDIT PRESET screen will load.

  • Page 86: Operational Stages

    Before operating ProSense™ cryoablation system, make sure you have completed all pre- operational stages. Warning Insertion of the introducer or cryoprobe into the target tissue is performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure™ Medical. European User Manual...
  • Page 87 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning Do not start the Freeze step before the cryoprobe cool zone center is aligned with the center of the target tissue. Warning Cryoprobe, introducer, temperature sensor and holder materials are not...

  • Page 88: Figure 80: Introducer Shaft Length

    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. Refer to Cryoprobe and Introducer IFUs for further details. Figure 80: Introducer shaft length The order in which you follow these steps is essential for maintaining sterility and patient safety.

  • Page 89: Freeze Step

    5.3.3.1 Pause Option The Pause option is only available for specific settings of the ProSense™ cryoablation system. Contact your IceCure™ Medical representative for further details and instructions. If enabled, the Pause option is available at any Freeze step of the cryoablation procedure, in Manual or in Automatic mode.

  • Page 90: Figure 82: Left: Pause Button Available; Right: Pause In Progress, Play Button Available

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 82: Left: Pause button available; Right: Pause in progress, Play button available Depending on when and how long the pause time is defined, it may affect the ice ball characteristics (size, temperature, etc.).

  • Page 91: Figure 84: Freeze Screen In Manual Mode

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 84: Freeze screen in Manual Mode • The progress of the Freeze step will be shown on the screen with a second counter and a blue active progress line.

  • Page 92: Figure 86: Extraction Screen In Manual Mode

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • When the Extraction is done, you may try to extract the cryoprobe from the tissue. • Pressing the Finish icon will terminate the procedure. Figure 86: Extraction screen in Manual Mode...

  • Page 93: Figure 87: Automatic Mode Screen: Press On Start To Begin The Freeze Step

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • Within a given protocol, if you want to increase/decrease the preprogrammed time of a step when the step has already started, use the +/- icons on the left side of the screen to add/subtract 15 seconds with each push.

  • Page 94: Thaw

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • The left side of the screen displays the Current step (Freeze, Thaw, or Extraction) and time left for this step. • The right side of the screen displays information concerning the overall Protocol, including total protocol time, time elapsed, protocol format, and changes you have made, if any, to the preprogrammed protocol.

  • Page 95: Figure 89: Extraction Screen During Procedure

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual • After the cryoprobe has been removed, apply momentary pressure to the insertion site. You may apply adhesive skin closure to the incision and cover it with a 4x4 gauze dressing.

  • Page 96: Figure 91: Completed Screen With 3 Options: Extraction, Relocate And Finish

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 91: Completed screen with 3 options: Extraction, Relocate and Finish. • To continue warming, press the Extraction icon. • For an additional Freeze step - press the RELOCATE icon and select a treatment cycle.

  • Page 97: Figure 92: Passive Thaw Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 92: Passive Thaw screen For an additional Freeze step, press the RELOCATE icon and select a treatment cycle. To end procedure, press Finish. Figure 93: Completed screen without Extraction option...

  • Page 98: Figure 94: Cryoprobe Placement Calculation Screen During Relocate

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 94: Cryoprobe Placement Calculation screen during relocate Figure 95: Dewar Replacement screen Figure 96: Dewar Replacement finished screen After each relocation, replace the Dewar when required and follow on-screen instructions for the additional Freeze step.

  • Page 99: Show Last Treatment

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Show Last Treatment The last treatment will be displayed by choosing LAST TREATMENT icon on the Main Menu screen. In this screen, you can see details of the last procedure that was performed including date, time, treatment mode, cryoprobe type and duration of treatment.

  • Page 100: Replace (Refill) The Dewar During A Cryoablation Procedure

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 99: Last Treatment screen after up to 3 Freeze steps Replace (refill) the Dewar during a cryoablation procedure Option to refill the Dewar is available at each Thaw step.

  • Page 101: Figure 101: Lowering The Dewar During Thaw Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 101: Lowering the Dewar during Thaw screen. The message "Please wait…Do not open the door yet!" will appear. • 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 102: Figure 103: Replacement Done Follow Up Screen

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 103: Replacement done follow up screen • When preparation of the new Dewar is complete, the system will resume the Thaw step (figure below). • To go to the next Freeze step, you have to press Skip – even if the time to complete the replacement exceeded the preset Thaw time (figure below).

  • Page 103: Figure 105: Replacement Was Completed After The Thaw Ended

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 105: Replacement was completed after the Thaw ended 5.3.7.1 Replace the Dewar during Freeze In case of low level of liquid nitrogen, the system can’t continue to Freeze. It will ask to refill the Dewar in Freeze step (see fig.

  • Page 104: Post-Operational Stages

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 107: Procedure stopped due to Low Liquid Nitrogen. If you press OK, you will get an "Extraction Completed screen" with 3 options: Extraction, Relocate and Finish. Figure 108: Extraction Completed screen.

  • Page 105: Removing The Cryoprobe From The Cryohandle

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Removing the cryoprobe from the cryohandle When a Hose-holder is used during the procedure, safely disengage the hose from the Holder device. After removing the cryoprobe from the target tissue, and the message that it is safe to...

  • Page 106: Exiting The Prosense™ Cryoablation System Treatment Mode

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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 107: General Advice For Patients

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 112: System Shutdown screen. Press OK to proceed. At the end of the last treatment of the day, Switch OFF the mechanical ON/OFF switch and unplug the electrical cable. Clean the system following instructions in section 8.1 and move the system to its storage location, using the dedicated handle.

  • Page 108: Prosense™ Cryoablation System Touch Screen Failure

    Warning In case of software crash, switch OFF the mechanical ON/OFF switch and unplug the electrical cable. Call IceCure™ Medical for technical service before restarting the ProSense™ cryoablation system. 5.5.2.1 Emergency Stop button The fastest way to end a procedure is to press EXTRACT on the screen (or the RED HANDLE button).

  • Page 109: Figure 114: Emergency Stop Button Located On The Main Chassis

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Figure 114: Emergency Stop button located on the main chassis 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: Warning Messages

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Warning messages Critical information will appear as a pop-up dialog with an OK button for acknowledging the message. When such a message appears, the user should carefully follow system instructions.
  • Page 112 User Manual 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.

  • Page 113: Accessories

    ProSense™ Confidential User Manual ACCESSORIES Expiration dates of all IceCure™ sterile accessories are specified by the appropriate labels on the external package as well as on the internal package. Cryoprobe Figure 119: Cryoprobe components (the figure is for illustration only).

  • Page 114: Introducer

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual percutaneous procedures under reduced mechanical stress. It is preferred to use the adapted lengths according to the superficiality of the lesions. Select the cryoprobe based on ice ball size you want to obtain and the cooling zone location as defined in the table above.

  • Page 115: Foot Pedal (Not Available In Some Regions, E.g. China)

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual Foot pedal (Not available in some regions, e.g. China) The foot pedal (Not available in some regions, e.g. China) is a pneumatic accessory, external to the main chassis and is not essential for normal functioning of the system. It serves as an alternative way to select actions displayed on the screen, instead of pressing the active buttons on the screen.

  • Page 116: System Maintenance

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual SYSTEM MAINTENANCE General cleaning Warning Do not allow any liquid or humidity to enter the cryohandle. Always keep the cover on the cryohandle. Following each cryosurgical procedure, discard the single use devices (single-use cryoprobe, single-use temperature sensor, cryohandle cover, and sleeves for the hose and touch screen).

  • Page 117: Sterility

    Reprocessing single-use devices affects their performance and can cause cross-contamination. The sterile sleeves and covers are single-use and are not supplied by IceCure™ Medical in single use packaging. The sterile single use sleeves are used to cover the hose up to the cryoprobe and maintain sterility.

  • Page 118: Troubleshooting

    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 119 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 system will alert of “Dewar is up during Freeze step empty”...
  • Page 120 Burned out LED, or it should not Check user manual to verity that the be lighting up at given time. 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 121 Then turn ON the system (after releasing the emergency stop button, if pressed) and wait for computer re-boot. If there is a cryoprobe in the target tissue, refer to training materials provided by IceCure™ Medical for further details. European User Manual...
  • Page 122 In case you clicked “O.K” the screen freeze till the end of the “long wash” procedure. • Prepare for Treatment 1) Contact IceCure™ Medical Maintenance is needed button in the Main • service representative. Washing is in progress...

  • Page 123: Prosense™ Cryoablation System - Step-By-Step Procedure

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual ProSense™ cryoablation system - Step-by-Step procedure Before starting the procedure, a functional test must be carried out! System preparation and Functional test 1. Press Prepare for treatment. 2. Remove the Dewar’s cap and fill the Dewar with liquid nitrogen in a safe manner.

  • Page 124: System Specifications

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual SYSTEM SPECIFICATIONS Height: 120 cm (47.24 inches) Dimensions Physical properties Depth: 70 cm (27.56 inches) (excluding the screen) Width: 50 cm (19.68 inches) Weight 150kg 100-127 VAC 12 A 50/60 Hz, single phase...

  • Page 125: Limited Warranty Certificate

    Warranty Number: Date of supply of equipment: Date of expiration of this warranty certificate: Buyer of the equipment: IceCure™ Medical representative: ___________________________________ European User Manual...

  • Page 126: Customer Complaint Form

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual CUSTOMER COMPLAINT FORM Section 1: Customer complaint (To be filled by customer / complaint recipient) European User Manual...

  • Page 127: Report Customer Complaint

    HaEshel 7, 2 floor, P.O.B 3163, Caesarea 3079504, Israel support@icecure-medical.com Tel: +972-4-623 0333 Fax: +972-4-623 0222 MedNet EC-REP GmbH – Authorized Representative of IceCure Medical Ltd. Borkstraße 10 48163 Münster Germany Tel +49 (0) 251 32266-0 Fax +49 (0) 251 32266-22...

  • Page 128: Cryoablation Clinical References

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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 129 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual b, John C. Cheville d, Stephen A. Boorjian a, Bradley C. Leibovich. Comparison of Partial Nephrectomy and Percutaneous Ablation for cT1 Renal Masses. European Urology 6 7 (2015) 252 – 259 17.
  • Page 130 IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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. Wang C, Wang H, Yang W, Hu K, Xie H, Hu KQ, Bai W, Dong Z, Lu Y, Zeng Z, Lou M, Wang H, Gao X, Chang X, An L, Qu J, Li J, Yang Y., Multicenter randomized controlled trial of...

  • Page 131: Manufacturer's Declaration Of The Eut

    IceCure™ Medical Ltd. DMS-7064 rev. C ProSense™ Confidential User Manual 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 132 IceCure™ Medical Ltd. DMS-7064 rev. C 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 133 IceCure™ Medical Ltd. DMS-7064 rev. C 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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