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User Manual
DSR3000000 rev. L
Please read this document carefully before using the IceSense3™
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
498 Halle Park Dr., Ste. 102
Collierville, TN 38017
icecuresupport@icecure-medical.com
Toll-free 888-516-7389
Tel 901.316.5672
Fax 901.316.5944
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
HaEshel 7, 2
floor
Southern Industrial Park,
Caesarea 38900, Israel
info@icecure-medical.com
Tel: +972-4-623 0333
Fax: +972-4-623 0222
1
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Summary of Contents for IceCure IceSense3
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Page 1: User Manual
User Manual DSR3000000 rev. L Please read this document carefully before using the IceSense3™ cryoablation system. Do not attempt to perform any procedure before carefully reading all instructions. Always follow product labeling and manufacturer’s recommendations. If in doubt as to how to proceed in any situation, contact your IceCure Medical representative. -
Page 2: Table Of Contents
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Table of Contents OVERVIEW ........................7 Introduction ......................7 Intended use ......................7 Indications for use ....................7 Qualified users ......................8 Clinical decisions ....................9 Qualified technician ....................9 SAFETY NOTES ......................10 Warnings and cautions .................. - Page 3 Removing the temperature sensor from tissue ..........78 5.4.2 Removing the cryoprobe from the cryohandle ..........79 5.4.3 Disassembling the temperature sensor ............80 Exiting the IceSense3™ cryoablation system treatment mode ...... 80 5.4.4 System failures ...................... 81 IceSense3™ cryoablation system failure ............81 5.5.1 IceSense3™...
- Page 4 Figure 15: Label 15- Applied parts - MLS1000014 Rev. A ..........28 Figure 16: Label 16- Shipping Art Work ................28 Figure 17: Front and back view of the IceSense3™ cryoablation system with numbered components .......................... 32 Figure 18: The IceSense3™ transportation rollers & brakes..........33 Figure 19: The Emergency Stop button ................
- Page 5 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 24: The foot pedal ..................... 37 Figure 25: The temperature sensor and its components ............38 Figure 26: Temperature display of sensor in the procedure screen (green arrow) ....39 Figure 27: Dewar storage cases –...
- Page 6 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 71: Protocol Completed screen. Pressing on the “Main Menu” icon (green arrow) will load the Main Menu screen..................80 Figure 72: The Main Menu screen. To exit the system, press on the “Exit” icon (green arrow).
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Page 7: Overview
1.3 Indications for use IceSense3™cryoablation system is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology as detailed below. The IceSense3™cryoablation system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure. -
Page 8: Qualified Users
The IceSense3™cryoablation system is indicated for patients whom the surgeon has designated as eligible for cryotherapy. 1.4 Qualified users You are a qualified IceSense3™ cryoablation system user only if you meet all of the following criteria: You are a board certified medical practitioner licensed in your country. -
Page 9: Clinical Decisions
User Manual Warning If you do not meet the above criteria, you should not use the IceSense3™ cryoablation system. Practitioners electing to be IceSense3™ cryoablation system users must attend a training course prior to using the system. The course is taught by IceCure Medical certified personnel. -
Page 10: Safety Notes
User Manual 2 SAFETY NOTES While this manual is designed to provide instructions in the use of the IceSense3™ cryoablation system, it is not intended to take the place of the user training course which must be completed before using the system. -
Page 11: Training
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. -
Page 12: Clinical Assessment
See 5.2.2 Warning The supplier and manufacturer of the IceSense3™ cryoablation system do not claim that it will be useful for assisting with the treatment of any particular condition or set of circumstances. Full responsibility for assessing the potential benefit of the system for a given medical condition lies with the practitioner. -
Page 13: Installation And Setup
The IceSense3™ cryoablation system must be unpacked, installed, and tested by an IceCure Medical authorized technician only. See 4.2 Caution There are no user-serviceable parts in the system. Refer all service issues to IceCure Medical’s Customer Service Department. See 8.3 Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure. -
Page 14: Proper Use
Always turn off the IceSense3™ cryoablation system and lock the wheels when not in use. Before you start a procedure lock two of the four wheels. Caution The IceSense3™ cryoablation system should be moved with care in order to avoid damage to the system or other clinical equipment. -
Page 15: Operating Warnings
Follow the detailed instructions on open the Dewar storage- when you want to replace a Dewar. See 5.2.7 Caution The system will not allow additional treatment when zero procedures left to maintenance. Make sure to call IceCure Medical service representatives in time. See 8 2.3 Operating warnings Warning... - Page 16 Ensure that the temperature sensor is securely connected. Warning Insertion of the cryoprobe into the target tissue is performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure medical. See 5.2.7 Warning The probe tip must be in the target tissue BEFORE starting the freeze treatment.
- Page 17 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning Before removing the temperature sensor from the tissue, make sure the freeze effect has been deactivated and the sensor can be easily withdrawn. Never use excessive force to extract the temperature sensor.
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Page 18: Liquid Nitrogen
2.4.1 Danger - explosion and fire hazard Warning The IceSense3™ cryoablation system includes electronic devices that may emit sparks and should therefore not be operated in the presence of ANY flammable material. IceSense3™ cryoablation system should be kept away from flammable fumes, e.g., flammable anesthetics or volatile substances. -
Page 19: Voltage And Power Ratings
User Manual 2.4.3 Voltage and power ratings Caution Verify that the IceSense3™ cryoablation system complies with the local voltage line. 2.4.4 Liquid nitrogen Safety Warning Liquid nitrogen may cause serious injury or burn if handled improperly. Local laws and safety rules regarding the maintenance and handling of liquid nitrogen Dewars should always be observed. -
Page 20: 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 technician or an authorized distributor for inspection. -
Page 21: Grounding
See 5.2.7 2.4.8 Mechanical handling of flexible 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. -
Page 22: Emergencies And Errors
2.5.2 Emergencies causing procedure halt Warning When a procedure halts due to an error, switch off the system. Call IceCure Medical and describe the error shown on the screen as precisely as possible. Do NOT attempt to reuse the system before contacting IceCure Medical. -
Page 23: Adverse Events
Call IceCure Medical for technical service before restarting the IceSense3™ cryoablation system. Warning When the system shuts itself down due to an error, contact IceCure Medical and describe the error message shown on the screen as precisely as possible. Do not attempt to reuse the system before contacting IceCure Medical. -
Page 24: Accompanying Labels
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Not suitable for use in presence of flammable anesthetic mixture with air or nitrous oxide. 2.9 Accompanying labels Label 1 – On/off mechanical button on the console Label 2 – Emergency Stop button Label 3 –... -
Page 25: Figure 1: Label 1 - On/Off Mechanical Button - Mls1000002 Rev. B
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual System Labels: Figure 1: Label 1 - On/Off mechanical button - MLS1000002 Rev. B Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B Figure 3: Label 3 - Identification - MLS3080001 Rev. F... -
Page 26: Figure 5: Label 5 - Follow Instructions For Use - Mls1000005 Rev. C
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 5: Label 5 - Follow instructions for use - MLS1000005 Rev. C Figure 6: Label 6 - High voltage caution - MLS1000006 Rev. B Figure 7: Label 7 - Line voltage danger - MLS1000007 Rev. B Figure 8: Label 8 - Foot pedal - MLS1000008 Rev. -
Page 27: Figure 10: Label 10 - Single Use Probe - Mlp7000001 Rev. F
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 10: Label 10 - Single use probe - MLP7000001 Rev. F Figure: Label 11 - Single use temperature sensor - MLT8000001 Rev. C Figure 11: Label 11 - Single use temperature sensor - MLT8000001 Rev. F... -
Page 28: Figure 13 Label 13 - Cold Area - Mls1000010 Rev. B
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 13 Label 13 – Cold area - MLS1000010 Rev. B Figure 14: Label 14- Empty LN2 Dewars - MLS1000012 Rev. A Figure 15: Label 15- Applied parts - MLS1000014 Rev. A... -
Page 29: Important Symbols And Labels
2.9.1 Important Symbols and Labels A number of internationally recognized symbols relating to safety requirements and standards are found on the IceSense3™ cryoablation system. These symbols are listed in the table below. Table 1.1 International Symbols on IceSense3™ cryoablation system... - Page 30 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Symbol Meaning 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. Never dispose of electrical and electronic components in general municipal waste receptacles.
- Page 31 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Symbol Meaning This side up 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...
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Page 32: System Description
IceSense3™ cryoablation system is indicated for patients whom the practitioner has designated as eligible for cryotherapy. 3.3 Major components The following figure illustrates external features of the IceSense3™ cryoablation system: Figure 17: Front and back view of the IceSense3™ cryoablation system with numbered components 1. Touch screen 2. Cryoprobe holder 3. Cryohandle... -
Page 33: Main Chassis
3.3.1 Main chassis The IceSense3™ 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 34: Flexible Hose
It is designed for users and technicians. Do not connect any signal input/output port to the touch panel PC except medical certified equipment provided by IceCure Medical. A sample touch screen display is represented by the figure below. For further information about... -
Page 35: Cryohandle And Cryoprobe
The cryohandle is situated at the end of the flexible hose that projects through the upper area of the front panel of the IceSense3™ cryoablation system unit. The cryoprobe is connected to the cryohandle. The cryohandle allows for maneuvering of the cryoprobe within the target tissue. -
Page 36: Handle Plug Holder
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 22: The 90 degrees cryohandle and connected cryoprobe (Not available in some regions, e.g. USA) 1. Cryohandle 2. Cryoprobe insertion point 3. Cryoprobe Warning Never reuse a single-use cryoprobe, temperature sensor or sterile sleeve. -
Page 37: Foot Pedal (Not Available In Some Regions, E.g. China)
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 23: Handle plug holder and handle plug. 3.3.7 Foot pedal (Not available in some regions, e.g. China) The pedal is an alternative to the Action button on the cryohandle; pushing the pneumatic foot pedal is identical to pushing the Action button. -
Page 38: Figure 25: The Temperature Sensor And Its Components
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning Do not rely solely on the temperature sensor measurement. Always monitor the procedure using Ultrasound or other appropriate imaging system. The temperature sensor and its components are depicted in the following figure. -
Page 39: Dewar Storage Cases
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 26: Temperature display of sensor in the procedure screen (green arrow) Warning Temperature sensor insertion and navigation within tissue MUST be done under guidance of an appropriate imaging device. 3.3.9 Dewar storage cases The Dewar storage cases are located at the back of the chassis. -
Page 40: Operational Details
Confidential User Manual 3.4 Operational details This section describes the operational actions of the IceSense3™cryoablation system that support the functional operations described in Chapter 5. Order liquid nitrogen in advance based on projected case load. Industrial grade liquid nitrogen should be delivered to the user’s site in a standard cryogenic Dewar. -
Page 41: System Pre-Tests
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 28: The system is loading screen Wait for the Main Menu screen to load. Figure 29: The Main Menu screen 3.4.2 System pre-tests As the system uploads, several internal built-in tests are performed automatically in order to verify that the system is safe for use. -
Page 42: Cryoablation Procedure
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 3.4.3 Cryoablation procedure The cryoablation procedure can only be performed after the cryoprobe has been inserted in the target tissue. It can be activated by Manual mode (controlled by the user) or by Automatic mode (pre-programmed and monitored by the computer). -
Page 43: Installation And Setup
Dewars should always be observed. 4.2 Setup warnings and cautions Warning If there is not sufficient ventilation in the room, the IceSense3™ cryoablation system cannot be used due to risk of suffocation due to increased levels of nitrogen in the room. Caution The IceSense3™... -
Page 44: Electrical Requirements
Do not move the system when the Dewar contains liquid nitrogen. 4.3 Electrical requirements The IceSense3™ cryoablation system is pre-wired for the local line voltage as specified by the user. Accordingly, the unit will require a line supply of 115-120 VAC, 13 A, 50/60 Hz, single phase. -
Page 45: Operating The System
For these applications the practitioner should follow standard clinical procedures that are not within the scope of this user manual. TRAINING: Practitioners electing to be IceSense3™ 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 46: Switching On The Icesense3™ Cryoablation System
Figure 30 : Schematic illustration of placement of the system and patient. Warning The handle and hose portions of the IceSense3™ cryoablation system may become cold during the cryoablation procedure. Operators should consider insulating these parts in order to prevent discomfort to the patient. -
Page 47: Figure 31: The System Is Loading Screen
The mechanical power switch is OFF. The cryohandle, flexible hose and cryoholder are all clean and dry. To Switch on the IceSense3™ cryoablation system: To switch the system ON, turn on the mechanical button at the back of the system, the touch... -
Page 48: Cryohandle
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 5.2.4 Cryohandle The cryohandle allows the user to easily and safely handle the cryoprobe. It also allows for several operational functions. The cryohandle parts are detailed in Chapter 3 - System description. -
Page 49: General Settings
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual In this screen you can see details of the last procedure that was performed including date, time, treatment mode, probe type and duration of treatment. 5.2.6 General settings The system general settings and technician mode is available by choosing the “Settings” button on left lower corner of the touch screen (Fig. -
Page 50: Figure 38: The Change Workflow Screen With Two Alternative Workflow Settings
5.2.6.2 Log-in to Technician mode Choosing the “Technician Mode” icon will load a Technician Mode entry screen that is used for maintenance of the system. The technician mode can only be accessed by an IceCure Medical authorized technician and is restricted by a password. -
Page 51: Preparing The System For Treatment
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 5.2.6.3 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 appears with the... -
Page 52: Figure 40: Preparing The System For Treatment By Pressing "Prepare For Treatment" (Green Arrow) On Main Menu Screen
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 1. Dewar refilling and replacement 2. Maintain Sterility (Use of sterile sleeves) 3. Cryoprobe registration and connection 4. System tests To prepare the system for treatment, choose the option “Prepare for Treatment” in the Main Menu as shown in the below figure. - Page 53 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 IceCure technician or an authorized distributor for inspection Warning Do not transfer a Dewar with Liquid nitrogen unless it is covered with a lid.
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Page 54: Figure 41: The Dewar Preparation Screen
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 41: The Dewar preparation screen 5.2.7.2 Cryoprobe Selection Select a cryoprobe according to your clinical judgment. Approxima Iceball Size Probe Approximate Treatment (diameter) Size Cycle Times Time Freeze 1 Thaw Freeze 2 ≤... -
Page 55: Figure 43: The Cryoprobe (The Figure Is For Illustration Only)
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Serial number Figure 43: The cryoprobe (the figure is for illustration only) Enter the serial number of the cryoprobe using the number icons on the screen. When done, confirm the number is correct and press the Action button on the handle or “Next” on the touch screen. -
Page 56: Figure 45: Cryoprobe Connection Screen
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 5.2.7.4 Cryoprobe connection Connect the cryoprobe to the cryohandle as follows, while maintaining sterility of the probe: Remove the plug that covers the probe connection point. Insert the cryoprobe into the insertion point in the handle as shown on screen and screw it until a “Next”... - Page 57 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning If the procedure is not yet underway after a cryoprobe is screwed onto the cryohandle, hang the cryohandle in its holder to prevent a stabbing injury from the cryoprobe. Be sure to maintain sterility of the cryohandle and cryoprobe.
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Page 58: Figure 46: Functional Test Screen
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. You will be prompted to inspect the following: o The cryoprobe tip –... -
Page 59: Figure 47: Functional Test - Visual Inspection Screen
To start again Check that the Dewar is full and replace the probe. If the problem recurs, do not proceed with treatment. Turn off the system and contact IceCure Medical. If a functional problem occurs as represented by one of the pictures, press on the relevant picture. -
Page 60: Treatment Selection
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning During pre-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 61: Figure 49: Define A Treatment Protocol By Choosing Edit Presets On The Treatment Selection
User Manual 5.2.7.9 Define treatment protocols IceSense3™ cryoablation system allows you to define specific treatment protocols by pressing the “Edit Presets” icon at the bottom of the Treatment Selection screen or in the Main Menu screen. Figure 49: Define a treatment protocol by choosing Edit Presets on the Treatment Selection screen (green arrow) or in the Main Menu screen (yellow arrow) Choosing either option will open the “Preset Setup”... -
Page 62: Figure 51: Steps For Adding A Protocol
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Please follow the next steps: 1. Choose the number of freeze cycles in the upper left corner of the screen. 2. Decrease/increase the time for every cycle using +/- icons. Each step will increase/decrease 15 seconds of the cycle time. -
Page 63: Operational Stages
5.3.2 Preliminaries Before operating IceSense3™ cryoablation system, make sure you have completed all pre- operational stages. Warning Insertion of the cryoprobe into the target tissue is performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure medical. - Page 64 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning You must NOT allow the freeze process to start before the cryoprobe tip is actually within the target tissue. Before activating the freeze cycle, insert the cryoprobe into the target tissue according to the following steps: 1.
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Page 65: Freeze Cycle
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual The order in which you follow these steps is essential for maintaining sterility and patient safety. First, insert the probe tip into the target tissue. Be aware of the markings on the probe: the wide mark closest to the tip is the safety mark. -
Page 66: Pause Option
The pause time does not affect the freeze preprogrammed time but depending on when and how long the pause time is defined it may affect the iceball size. The physician should always monitor the iceball size during the whole procedure. IceCure Medical recommends is to use pause only if necessary. -
Page 67: Manual Freeze Mode
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 5.3.5 Manual freeze mode Choosing the Manual freeze mode will open the treatment screen for manual mode as show in Fig. To activate the freeze cycle, press the Action button on the cryohandle, and hold it for one second or press the “Freeze”... -
Page 68: Figure 58: Thaw Screen In Manual Mode
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual The “Freeze” icon will change to a “Thaw” icon and will allow you to move from freeze cycle to thaw cycle by pressing that icon or the Action button on the cryohandle. -
Page 69: Figure 59: Warm Screen In Manual Mode
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 58: Warm screen in Manual Mode During the manual procedure the system provides information regarding treatment progress: The left side of the screen displays the Current Step (freeze, thaw or warm cycle) and time elapsed for this specific step. -
Page 70: Thaw
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual You can move from the automatic mode AT ANY TIME by pressing the Manual mode button on the screen, without interrupting the procedure. When in Manual, you can’t go back to Automatic mode. -
Page 71: Active Warm Process
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 5.3.7 Active warm process The active warm step occurs at the end of every treatment. Its purpose is to allow the cryoprobe’s removal from the target tissue in the fastest and safest way. -
Page 72: Replace The Dewar During A Cryoprocedure
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual The system will then perform several verification steps and it will inform you when it is safe to disengage the probe. In case the active Warm process isn’t available, wait for passive Thaw. -
Page 73: Figure 62 : Replace Dewar Option Question
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual In case you intend to do a long treatment that will freeze over 12 minutes, replace the Dewar during the thaw time of the procedure. First be always ready with an additional full Dewar in case you consider you may need an additional Dewar for a longer freeze time. -
Page 74: Figure 63: Lowering The Dewar
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 61: Lowering the Dewar The system will perform several steps, then it will inform you that it is safe to replace the Dewar and you will get the "Replace Dewar screen" (figure 64 below) ... -
Page 75: Figure 65: The Replacement Done Follow Up Screen
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual After pressing the 'OK' button, the system will proceed and prepare the new Dewar that was entered. The screen will show "Proceeding, please wait… " (figure below) Figure 63: The replacement done follow up screen ... -
Page 76: Figure 66: Replacement Was Completed Before The Thaw Ended
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning If you don’t press skip after replacing Dewar, the system will stay in Thaw mode. Figure 64: Replacement was completed before the Thaw ended... -
Page 77: Figure 67: Replacement Was Completed After The Thaw Ended
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Figure 65: 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. So it will ask to refill the Dewar in Freeze cycle (see fig. -
Page 78: Post-Operational Stages
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual When pressing OK, the system will move to Manual mode and be in a Thaw cycle. Pay attention that in Manual mode, you need to press the icon on the screen for each freeze or thaw cycle. -
Page 79: Removing The Cryoprobe From The Cryohandle
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Warning Before removing the temperature sensor from the tissue, make sure the freeze effect has been deactivated and the sensor can be easily withdrawn. Never use excessive force to extract the temperature sensor. -
Page 80: Disassembling The Temperature Sensor
If a temperature sensor was used, pull the gray part of the cable connector backwards to release it, and then pull the cable connector away from the front panel. 5.4.4 Exiting the IceSense3™ 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”... -
Page 81: System Failures
3. Detach the cryoprobe from the cryohandle ONLY after Dewar the system instructs you that it is safe to do so. 4. If system shut down is required, shut off the IceSense3™ cryoablation system by pressing the mechanical ON/OFF button on the main chassis and then remove the plug from the power supply. - Page 82 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 IceSense3™ cryoablation system. 5.5.2.1 Emergency Stop button The fastest way to end a procedure is to press the Warm button in the handle or on the screen.
- Page 83 IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual To release the Emergency Stop button, turn it clockwise.
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Page 84: Computer Interface
The technician menu/screen can be accessed by pressing the setting icon on the left lower corner of the main menu screen and then pressing the Technician icon. The technician mode can only be accessed by an IceCure Medical authorized technician and is restricted by a password. It is used for maintenance of the system. -
Page 85: System Messages
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 3. Wizard/Instruction bar 4. Main interaction area 5. Icons 6. Status display 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 86: Error Messages
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual Headline User Instructions Figure 74: Warning message format example 6.3.3 Error messages Information that prevents the user from continuing the operation of the system will appear as a dialog box that cannot be closed, stating the problem and possible solutions. - Page 87 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. After reporting or making note of the error...
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Page 88: Accessories
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 7 ACCESSORIES 7.1 Cryoprobe Distal Insertion 7.1.1 Single use sterile cryoprobe part Plastic grip Serial number Shaft Probe tip Figure 76: The cryoprobe components (the figure is for illustration only). There are various cryoprobe configurations. Certain configurations are not available in some regions. -
Page 89: The Foot Pedal (Not Available In Some Regions, E.g. China)
DSR3000000 rev.L IceSense3™ Confidential User Manual In General IceSense3 cryoprobes characteristics are length: 120-450 mm, diameter: 2-4 mm and sharp or blunt tips. Choose the cryoprobe based on iceball size you want to obtain. For example: Iceball size Cool zone... -
Page 90: System Maintenance
Medical professional surface disinfecting wipes and dry it in air. Thoroughly clean the IceSense3™ cryoablation system unit with a damp cloth and warm soapy water. Dry it with a clean cloth. Clean the monitor screen with a soft cloth and a mild window cleaning solution. -
Page 91: Periodic Servicing
The IceSense3™ cryoablation system is not user-serviceable. Refer all service issues to IceCure Medical’s Customer Service Department. If there is any malfunctioning of the IceSense3™ cryoablation system, please contact IceCure Medical technical support. The technician should disconnect the system from the electrical outlet before removing external covers of the system. -
Page 92: Troubleshooting
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 93 Dewar is jammed and Dewar is not in place or is If Dewar cannot be removed, cannot be removed. blocked by an unknown object. close the door and call IceCure Medical service. System provides System identifies wrong or Verify that the number you “Wrong cryoprobe...
- Page 94 Make sure that the procedure has ended, wait 3 minutes and try removing the cryoprobe again. If nitrogen is still leaking contact IceCure Medical service. Computer failure due Unknown Mechanical shut down of the to hardware fault system using the On/Off switch at the back of the system or emergency stop.
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Page 95: Icesense3™ Cryoablation System - Step-By-Step Procedure
DSR3000000 rev.L IceSense3™ Confidential User Manual 10 IceSense3™ 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 96: System Specifications
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 11 SYSTEM SPECIFICATIONS Physical properties Dimensions (excluding the Height: 120 cm (47.24 inches) screen) Depth: 70 cm (27.56 inches) Width: 50 cm (19.68 inches) Weight 150kg Electrical requirements 100-120 VAC 16 A... -
Page 97: Temperature Distribution Analysis In Homogeneous Medium
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 12 TEMPERATURE DISTRIBUTION ANALYSIS IN HOMOGENEOUS MEDIUM A model of a homogenous medium, that freezes at 0°C, and is cooled with a round 3.4mm diameter cold finger is used in order to estimate the radial distance from the 0°C isotherm (border of ice ball) to the -20°C and -40°C isotherms respectively. -
Page 98: Limited Warranty Certificate
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 13 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 99: Customer Complaint Form
IceCure Medical Ltd. DSR3000000 rev.L IceSense3™ Confidential User Manual 14 CUSTOMER COMPLAINT FORM Section 1: Customer complaint (To be filled by customer / complaint recipient) Complaint reported by: Phone Email Letter Sales representatives Website Other: __________________ Name: ________________ Title / Position: __________________... -
Page 100: Report Customer Complaint
HaEshel 7, 2 floor Southern Industrial Park, Caesarea 38900, Israel info@icecure-medical.com Tel: +972-4-623 0333; Fax: +972-4-623 0222 MedNet GmbH – Authorized Representative of IceCure Medical Ltd. Borkstraße 10 48163 Münster Germany Tel +49 (0) 251 32266-0 Fax +49 (0) 251 32266-22... -
Page 101: Manufacturer's Declaration Of The Eut
Guidance and manufacturer’s declaration-electromagnetic emission The model IceSense3 Cryotherapy product is intended for use in the electromagnetic environment specified below. The customer or the user of the model IceSense3 Cryotherapy product should assure that it is used in such an environment. - Page 102 Guidance and manufacturer’s declaration-electromagnetic immunity The model IceSense3 Cryotherapy product is intended for use in the electromagnetic environment specified below. The customer or the user of the model IceSense3 Cryotherapy product should assure that it is used in such an environment.
- Page 103 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the model IceSense3 Cryotherapy product is used exceeds the applicable RF compliance level above, The model IceSense3 Cryotherapy product should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the model IceSense3 Cryotherapy product.
- Page 104 The model IceSense3 Cryotherapy product is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the model IceSense3 Cryotherapy product can help prevent electromagnetic interference by maintaining a minimum distance...
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