IceCure DSR3200000 User manual

1
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
[email protected]
Tel: [phone]
IceCure Medical Ltd.
7 Haeshel St., 2nd floor, P.O.B 3163
Caesarea 3079504, Israel
[email protected]
Tel: [phone]
Fax: [phone]
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.

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Contents
1OVERVIEW..................................................................................................................8
1.1 Introduction.............................................................................................................8
1.2 Intended use ............................................................................................................8
1.3 Indications for use...................................................................................................9
1.4 ProSense™ Qualified users...................................................................................10
1.5 Clinical decisions..................................................................................................10
1.6 Contraindications ..................................................................................................11
1.7 Qualified technician ..............................................................................................11
1.8 Advanced Operator ...............................................................................................11
2SAFETY NOTES ........................................................................................................12
2.1 Warnings and cautions..........................................................................................12
2.2 Basic safety principles...........................................................................................12
2.2.1 Ownership......................................................................................................12
2.2.2 Qualification ..................................................................................................12
2.2.3 Training..........................................................................................................13
2.2.4 Clarity ............................................................................................................13
2.2.5 Clinical Assessment.......................................................................................14
2.2.6 .......................................................................................................................14
2.2.6 Installation and Setup.....................................................................................16
2.2.7 Proper use ......................................................................................................17
2.3 Operating warnings...............................................................................................19
2.4 Liquid nitrogen......................................................................................................21
2.4.1 Danger - explosion and fire hazard................................................................21
2.4.2 Opening the Dewar compartment..................................................................22
2.4.3 Voltage and power ratings.............................................................................22
2.4.4 Liquid nitrogen Safety...................................................................................22
2.4.5 Burn hazards ..................................................................................................24
2.4.6 Grounding......................................................................................................25
2.4.7 Sterility...........................................................................................................25
2.4.8 Mechanical handling of hose and cryohandle................................................26
2.5 Emergencies and errors.........................................................................................26
2.5.1 Emergency Stop button..................................................................................26
2.5.2 Emergencies causing procedure halt..............................................................27
2.6 Adverse events ......................................................................................................27
2.7 Disposal.................................................................................................................28
2.8 Compliance ...........................................................................................................29
2.8.1 Compliance with international safety standards............................................29
2.9 Equipment classification.......................................................................................29
2.10 Accompanying labels ........................................................................................29
2.10.1 Important Symbols and Labels......................................................................36
3SYSTEM DESCRIPTION...........................................................................................40
3.1 Introduction...........................................................................................................40
3.2 Concept of operation.............................................................................................40
3.3 Major components.................................................................................................41
3.3.1 Main chassis...................................................................................................42
3.3.2 Emergency Stop button..................................................................................42

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3.3.3 Flexible hose..................................................................................................43
3.3.4 Touch screen and User Manual activation.....................................................43
3.3.5 Cryohandle and cryoprobe.............................................................................45
3.3.6 Holder –Optional (Not available in some regions, e.g. China).....................47
3.3.7 Foot pedal (Not available in some regions, e.g. China).................................48
3.3.8 Temperature sensor (TS) ...............................................................................48
3.3.9 Dewar storage cases.......................................................................................50
3.4 Operational details ................................................................................................50
3.4.1 Starting the system.........................................................................................51
3.4.2 System pre-tests.............................................................................................52
3.4.3 Cryoablation procedure..................................................................................52
3.4.4 EXTRACTION step ......................................................................................52
4INSTALLATION AND SETUP .................................................................................53
4.1 Space and positioning requirements......................................................................53
4.2 Setup warnings and cautions.................................................................................53
4.3 Electrical requirements..........................................................................................54
4.3.1 For countries in which local line voltage is 100-127 VAC ...........................54
4.3.2 For countries in which local line voltage is 220-240 VAC ...........................54
4.4 Shipment components...........................................................................................54
4.5 Installation.............................................................................................................55
5OPERATING THE SYSTEM .....................................................................................56
5.1 Procedure Overview..............................................................................................56
5.2 Pre-operational stages ...........................................................................................56
5.2.1 Preparing the system for procedure ...............................................................56
5.2.2 Preparing the patient for procedure ...............................................................57
5.2.3 Switching on the ProSense™ cryoablation system .......................................58
5.2.4 Cryohandle.....................................................................................................59
5.2.5 General settings..............................................................................................59
5.2.6 Preparing the system for treatment................................................................63
5.2.7 Treatment Selection.......................................................................................81
5.3 Operational stages.................................................................................................87
5.3.1 Safe Operation in Percutaneous Procedures..................................................87
5.3.2 Preliminaries..................................................................................................87
5.3.3 Freeze Cycle ..................................................................................................89
5.3.4 Pause Option:.................................................................................................90
5.3.5 THAW ...........................................................................................................95
5.3.6 EXTRACTION process.................................................................................95
5.3.7 Show Last Treatment...................................................................................101
5.3.8 Replace (refill) the Dewar during a cryoprocedure .....................................102
5.4 Post-operational stages........................................................................................107
5.4.1 Removing the temperature sensor from tissue.............................................107
5.4.2 Removing the cryoprobe from the cryohandle ............................................107
5.4.3 Disassembling the support device - Hose-Holder........................................108
5.4.4 Disassembling the temperature sensor.........................................................108
5.4.5 Exiting the ProSense™ cryoablation system treatment mode.....................108
5.5 Instruct patients:..................................................................................................109
5.6 System failures....................................................................................................110
5.6.1 ProSense™ cryoablation system failure ......................................................110

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5.6.2 ProSense™ cryoablation system touch screen failure .................................111
6COMPUTER INTERFACE.......................................................................................113
6.1 The technician menu ...........................................................................................113
6.2 Reading the screen ..............................................................................................113
6.3 System messages.................................................................................................114
6.3.1 Status messages............................................................................................114
6.3.2 Warning messages .......................................................................................114
6.3.3 Error messages.............................................................................................115
7ACCESSORIES.........................................................................................................116
7.1 Cryoprobe............................................................................................................116
7.1.1 Single use sterile cryoprobe.........................................................................116
7.2 The foot pedal .....................................................................................................117
7.3 The temperature sensor .......................................................................................117
7.4 The Holder ..........................................................................................................118
7.5 Shelf life..............................................................................................................118
8SYSTEM MAINTENANCE .....................................................................................119
8.1 General cleaning..................................................................................................119
8.2 Sterility................................................................................................................120
8.3 Periodic servicing................................................................................................120
9TROUBLESHOOTING.............................................................................................122
9.1 General................................................................................................................122
9.2 Troubleshooting guide ........................................................................................122
10 ProSense™ cryoablation system - Step-by-Step procedure ......................................127
11 SYSTEM SPECIFICATIONS...................................................................................128
12 LIMITED WARRANTY CERTIFICATE ................................................................129
13 CUSTOMER COMPLAINT FORM.........................................................................130
14 REPORT CUSTOMER COMPLAINT.....................................................................131
15 Cryoablation Clinical References..............................................................................132
16 Manufacturer’s Declaration of the EUT ....................................................................135
Figures
Figure 1: Label 1 ON/OFF mechanical button - MLS1000002 Rev. B ..............................30
Figure 2: Label 2 - Emergency Stop - MLS1000003 Rev. B..............................................30
Figure 3: Label 3 - Identification - MLS3080104 Rev. A (220-240 VAC)
MLS3080103 Rev. A (100 –127 VAC)..............................................................................31
Figure 4: Label 4 - Follow instructions for use MLS 1000005 Rev D................................31
Figure 5: Label 5 - High voltage caution - MLS1000006 Rev. B.......................................31
Figure 6: Label 6 - Line voltage danger - MLS1000007 Rev. B.........................................31
Figure 7: Label 7 - Foot pedal - MLS1000008 Rev. B........................................................31
Figure 8: Label 8 - Risk of Explosion - MLS1000009 Rev. B............................................32
Figure 9: Label 9 - Single use cryoprobe (various options of shapes, tip, length and sizes) –
For Example: MLP7100100, MLP7200100........................................................................32
Figure 10: Label 10 –For illustration only, Color Tag Labels for Cryoprobes (A) and
matching Introducers (B) (MLP7000012 Rev. B, MLP7000018 Rev. C) and the position on
the external box....................................................................................................................32
Figure 11: Label 11 - Single use temperature sensor MLT8000101 Rev. A.......................33

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Figure 12: Label 12 - Liquid nitrogen Dewar - MLS1000001 Rev. E ...............................33
Figure 13: Label 13 - Black Dewar - MLS1000015 Rev. B................................................33
Figure 14: Label 14 –Cold area - MLS1000010 Rev. B.....................................................34
Figure 15: Label 15- Empty LN2 Dewars - MLS1000012 Rev. A .....................................34
Figure 16: Label 16- Applied parts - MLS1000014 Rev. A................................................34
Figure 17: Label 17- Holder –MLG1000008 Rev. B .........................................................34
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. A. ................................................................36
Figure 22: Front and back view of the ProSense™ cryoablation system with numbered
components..........................................................................................................................41
Figure 23: The ProSense™ transportation rollers & brakes................................................42
Figure 24: The Emergency Stop button...............................................................................42
Figure 25: The touch screen display before a cryoablation procedure...............................43
Figure 26: The User Manual screen.....................................................................................44
Figure 27: The User Manual Table of contents...................................................................44
Figure 28: The User Manual screen....................................................................................45
Figure 29: The hose, cryohandle and connected Cryoprobe ...............................................45
Figure 30: The 90 degrees cryohandle (No 1) and connected Cryoprobe (No 2) ...............46
Figure 31: Handle plug holder and handle plug. .................................................................46
Figure 32: The Cryohandle closed with the plug on the Handle holder..............................47
Figure 33: The Holder and the holder position within the CT machine..............................47
Figure 34: The Action button as displayed on screen (several of the options)....................48
Figure 35: The foot pedal.....................................................................................................48
Figure 36: The temperature sensor and its components ......................................................49
Figure 37: Temperature display of sensor in the procedure screen (see no 1) ....................49
Figure 38: Dewar storage cases –the correct way to put the Dewars inside the storage
shelf......................................................................................................................................50
Figure 39: The system is loading screen..............................................................................51
Figure 40: The Main Menu screen.......................................................................................51
Figure 41 : Schematic illustration of placement of the system and patient.........................57
Figure 42: The system is loading screen..............................................................................58
Figure 43: The Main Menu screen.......................................................................................59
Figure 44: The Action button as displayed on screen (several of the options)....................59
Figure 45: The EXTRACTION button as displayed on screen...........................................59
Figure 46: Activating the Settings option from the Main Menu screen ..............................60
Figure 47: The Settings screen.............................................................................................60
Figure 48: Language Selection screen.................................................................................61
Figure 49: Technician Mode screen.....................................................................................61
Figure 50: Export Log screen ..............................................................................................62
Figure 51: The Windows™ Date and Time Properties screen ............................................63
Figure 52: Preparing the system for treatment by pressing Prepare for Treatment (no. 1) on
Main Menu screen .........................................................................................................64
Figure 53: The Dewar preparation screen............................................................................64
Figure 54: Frost on the Dewar border..................................................................................65

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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....................................................................................................................67
Figure 57: Insertion of the Dewar.......................................................................................67
Figure 58: Dewar door open warning..................................................................................68
Figure 59: Ice ball isotherms of ProSense™ cryoprobe from experiments in gel at room
temperature. .........................................................................................................................71
Figure 60: Pre-Planning trajectory needle insertion ............................................................73
Figure 61: The cryoprobe (the figure is for illustration only)..............................................73
Figure 62: Cryoprobe registration screen ............................................................................74
Figure 63: Invalid serial number warning............................................................................74
Figure 64 : “PEEL HERE” label..........................................................................................75
Figure 65: Cryoprobe connection screen.............................................................................75
Figure 66: Cryoprobe reading failed....................................................................................76
Figure 67: Cryoprobe already used......................................................................................76
Figure 68: Cryoprobe expired..............................................................................................77
Figure 69: Wait for Functional test screen...........................................................................79
Figure 70: Functional test screen.........................................................................................79
Figure 71: Functional test - visual inspection screens.........................................................80
Figure 72: Treatment Selection screen ................................................................................82
Figure 73: Define a treatment protocol by choosing Setup Presets on the Treatment
Selection screen (see no 1)...................................................................................................83
Figure 74: Edit Presets in the Main Menu screen (see no 2)...............................................83
Figure 75: Editing an existing protocol (see no 1) or adding a new one (see no 2) ............84
Figure 76: Steps for adding a protocol................................................................................85
Figure 77: Edit Preset screen...............................................................................................86
Figure 78: Choosing the Manual Mode option (see no 1)...................................................87
Figure 79: Introducer shaft length .......................................................................................89
Figure 80: illustration of FAP7200000 cryoprobe Markings on the probe. ........................89
Figure 81: Pause (No 1) and Play (No 2) buttons during the freeze cycle. .........................91
Figure 82: Manual Mode screen: press on Freeze to start the freeze cycle.........................92
Figure 83: Freeze screen in Manual Mode ..........................................................................92
Figure 84: THAW screen in Manual Mode.........................................................................92
Figure 85: Extraction screen in Manual Mode ....................................................................93
Figure 86: Automatic Mode screen: press on Start to begin the freeze cycle. ....................94
Figure 87: Freeze screen in Automatic mode......................................................................95
Figure 88: The EXTRACTION screen during procedure ...................................................97
Figure 89: The Extraction screen.........................................................................................97
Figure 90: Completed screen with 3 options: Extraction, Relocate and Finish.................98
Figure 91: The Passive THAW screen ................................................................................99
Figure 92: Completed screen without Extraction option.....................................................99
Figure 93: Treatment selection screen during relocate......................................................100
Figure 94: Dewar Replacement screen..............................................................................100
Figure 95: Dewar Replacement finished screen................................................................100
Figure 96: Last Treatment screen after relocation.............................................................101
Figure 97: Last Treatment screen after more than 3 freeze cycles without relocation......101
Figure 98: Last Treatment screen after up to 3 freeze cycles............................................102

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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.........................................................104
Figure 103: Replacement was completed before the THAW ended .................................104
Figure 104: Replacement was completed after the THAW ended ....................................105
Figure 105: Replacement during Freeze, in case of empty Dewar....................................105
Figure 106: Procedure stopped due to Low Nitrogen.......................................................106
Figure 107: EXTRACTION Completed screen.................................................................106
Figure 108: Safe to Remove cryoprobe.............................................................................107
Figure 109: Protocol Completed screen. Pressing on the “Main Menu” icon (see no. 1)
will load the Main Menu screen. .......................................................................................108
Figure 110: The Main Menu screen. To shut down the system, press on the Shutdown icon
(see no 1)............................................................................................................................109
Figure 111: The System Shutdown screen. Press “OK” to proceed (see no 2). ................109
Figure 112: System Fail example screen...........................................................................110
Figure 113: The Emergency Stop button located ON the main chassis (see no. 1)...........111
Figure 114: A sample touch screen....................................................................................113
Figure 115: Status message example.................................................................................114
Figure 116: Warning message format example Pressing the OK button will indicate you
have read this message and will dismiss the popup...........................................................114
Figure 117: Error message format example.......................................................................115
Figure 118: The cryoprobe components (the figure is for illustration only).....................116
Figure 119: Counter of the remaining procedure before maintenance (see no 1) at the....121

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1OVERVIEW
1.1 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.
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
system is indicated for use as a cryosurgical tool in the fields of general surgery ,
dermatology, neurology (including cryoanalgesia), thoracic surgery , ENT, gynecology,
oncology , proctology, and urology . The system is designed to destroy tissue by the
application of extreme cold temperatures including prostate and kidney tissue, liver
metastases, tumors, skin lesions, and warts. The IceCure Family device, including the
ProSense cryoablation system may be used with an ultrasound device to provide real-
time visualization of the cryosurgical procedure.
The system is suitable for use in a number of cryotherapy applications. However, it is
ONLY indicated for use in patients whom the practitioner has deemed eligible for
cryotherapy.
The IceCure Family 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 system is indicated for use as a
cryosurgical tool in the fields of general surgery, dermatology, neurology (including
cryoanalgesia), thoracic surgery , ENT, gynecology, oncology , proctology and urology as
detailed below. The system is designed to destroy tissue by the application of extreme
cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin
lesions, and warts.

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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)).
Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative
intervention).
Dermatology
•ablation or freezing of skin cancers and other cutaneous disorders.
•palliation of tumors of the skin
•destruction of warts or lesions
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia).
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).
General Surgery
•Ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell
tumors of the eyelid or canthus area, ulcerated basal cell tumors,
dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar
warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and
seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
•palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and
recurrent cancerous lesions, ablation of breast fibroadenomas)
•destruction of warts or lesions.
•palliation of tumors of the oral cavity, rectum, and skin.
•ablation of breast fibroadenomas.
Thoracic Surgery (ablation of arrhythmic cardiac tissue and cancerous lesions.
Proctology (ablation of benign or malignant growths of the anus and rectum and
hemorrhoids).
The system may be used with imaging device like ultrasound to provide real-time
visualization of the cryosurgical procedure

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The system is indicated for patients whom the surgeon has designated as eligible for
cryotherapy.
1.4 ProSense™ Qualified users
You are a qualified ProSense™ cryoablation system user only if you meet all of the
following criteria:
You are a board-certified medical practitioner licensed in your country.
You have taken a certified ProSense™ cryoablation system training course.
You have read and understood all relevant material accompanying the ProSense™
cryoablation system.
Warning
If you do not meet the above criteria, do not use the ProSense™ cryoablation system.
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.
Warning
Do not use this system if you have not been adequately trained in its use.
1.5 Clinical decisions
The practitioner is solely responsible for all clinical use of the ProSense™ cryoablation
system and for any results obtained with the device.
Cryotherapy is beneficial in a variety of applications. However, sole responsibility for
determining when and how to use the system with a given patient and for a particular
medical condition lies with the practitioner.
Use of ProSense™ cryoablation system in special populations, such as pregnant women,
has not been established.
For further details, refer to Section 1.3 –Indications for use.