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User Manual DSR3100000 rev. K

1. 28 Figure 16 Label 16 Shipping Art Work eseeeeeeeeeeeeeeeeenenn nmm 28 Figure 17 Front and back view of the IceSense3 cryoablation system with numbered components ouooeo terr prec sas SEHR DEM E ORUM UEU OHNE DEM PRI UTD ERO UA YE 32 Figure 18 The IceSense3 transportation rollers amp brakes ssssssssesesese 33 Eieure I9 The Bmersency otop DUON o usse aa EE EERE 34 Figure 20 The touch screen display during a cryoablation procedure 35 Figure 21 The flexible hose cryohandle and connected cryoprobe 35 Proure 223 Amde plue NOC 0 cisosscaaecresiidawssaveuctiteuatavasatenchetu edastemeuctiqs wivuesessavenmunddtsecisianes 36 busure 25s The TODE e E E E E 36 Figure 24 The temperature sensor and its components sseeseessssssssssssssseeeeererreeesessssssss oT Figure 25 Temperature display of sensor in the procedure screen green arrow 38 Figure 26 Dewar storage cases the correct way to put the Dewars inside the storage anh e T re rte 38 4 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Ligure 27 The system s TOadiJg Screen ooo IR EUR EDEUI ERR LUUEY ae robos Eee icu Ene E EE een 40 Pioure 25 The Mai Menu SGEOD sron ena Io E E Un doo EE PII o I RE Psal bebe E pata uon 40 Figure 29 Schematic illustration of
2. If one or more of the wheels is damaged do not use the system Warning Cryoprobes are fragile and can be damage if mishandled Do not use a cryoprobe that has been bent dropped hit against a hard surface or compromised in any manner as internal damage to the cryoprobe may have occurred Caution Do not move the system when the dewar contains liquid nitrogen Warning Removing the dewar or placing it back within the system after refilling it must ONLY be done according to system instruction and with the carriage in the bottom position If the carriage is not in the bottom position liquid nitrogen may spill out Caution Follow the detailed instructions on open the dewar storage when you want to replace a dewar Caution The system will not allow additional treatment when zero procedures left to maintenance Make sure to call IceCure Medical service representatives in time 15 gt bP bb gt gt BP D IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 3 Operating warning Warning The cryoprobe tip must be covered when not within the target tissue Warning Ensure that the cryoprobe is securely connected Warning 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 Warning The probe tip
3. Estimated Diameter Isotherm mm Diameter of 20 C of 40 C Isotherm Iceball Diameter Isotherm mm mm Examples 1 If the diameter of the O C isotherm is measured to be 20mm the diameter of the 20 C isotherm is estimated to be 15 8mm and the diameter of the 40 C isotherm is estimated to be 12 9 90 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 lf one desires to obtain a diameter of 20 3 mm with 20 C the estimated Ice ball diameter that is required is 26mm 3 If one desires to obtain a diameter of 15 2 mm with 40 C the estimated Ice ball diameter that is required is 24mm 91 IceCure Medical Ltd DSR3100000 rev K 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 Our sole liability under valid warranty claims shall be limited at our option to repair or replace defective parts All warranty replacement or repair of parts shall be limited to equipment malfunction which in our reasonable opinion are due and traceable to defects in original material and workmanship In order to enable us to properly administer this warranty buyer shall not
4. User Manual DSR3100000 rev K 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 IceCure Medical Ltd 10000 Cedar Ave MS 13 2 floor HaEshel 7 2 floor Cleveland OH 44106 Southern Industrial Park icecuresupport icecure medical com Caesarea 38900 Israel Toll free 888 516 7389 info icecure medical com Tel 216 929 5153 Tel 972 4 623 0333 Fax 216 929 5143 Fax 972 4 623 0222 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 T lceSense3 IceCure and IceSense are trademarks of IceCure Medical Ltd in the United States and other countries IceCure Medical Ltd and other parties may also have trademark rights in other terms used herein IceCure Medical Ltd Confidential DSR3100000 rev K IceSense3 User Manual Table of Contents E OVERVIEW cc c 7 Ll OOU NON spere cad cu nea EU IHISUPIQU EIS ENIIS DUEEUUPPIURUICPRURMIEI OU CMIUSM STU DAR SUP DUUM UNE 7 IPAE e 6 or 6 Bt kc een ee eee eee ee pe en
5. screw the cryoprobe back in place 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 Mechanical shut down of the system using the On Off switch at the back of the system or emergency stop Then turn on the system after releasing the emergency stop button if pressed and wait for computer re boot Mechanical shut down of the system using the On Off switch at the back of the system or emergency stop Then turn on the system after releasing the emergency stop button if pressed and wait for computer re boot 87 IceCure Medical Ltd DSR3100000 rev K 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 Press Prepare for treatment Remove the Dewar s cap and fill the Dewar with liquid nitrogen in a safety manner Place the Dewar inside the system and close the door Press Next by pressing the BLUE button on cryohandle OR by pressing on the console touch screen Jr oS dU qeu Enter the probe serial number Each procedure must be carried out with a new sterile probe Press on the Next button on the screen 6 Remove the handle s cap attach the probe to the handle and press Next The next button will be shown only when the probe is connected properly The following m
6. 00 00 Freeze 00 0 Save Cancel Delete select the number of freeze cycles and set the times Figure 51 Edit Preset screen 5 2 8 5 Manual freeze mode The manual freeze mode allows you to perform a cryotherapy procedure without setting its duration or the number of freeze thaw cycles in advance You can choose manual freeze mode by pressing the Manual Mode icon at the bottom of the Treatment Selection screen 61 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Treatment Selection Calant QDEISCL Preset 01 Preset 02 Preset Preset Preset Manual Edit Presets Main Menu Probe 013 DO NOT DISCONNECT Figure 52 Choosing the Manual Mode option green arrow 5 3 Operational stages 5 3 1 Preliminaries Before operating IlceSense3 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 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 under ultrasound guidance or other appropriate imaging device according to the following steps 1 Planthe trajectory of the probe prior to placement The probe shall be centered and along
7. VP Tem 8 A Keep away from sunlight 31 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 3 SYSTEM DESCRIPTION 3 1 Introduction This chapter contains the following e Concept of operation IceSense3 cryoablation system intention for use e Major components description of the main system parts e Operational details system processes that occur as a result of user actions 3 2 Concept of operation The IceSense3 cryoablation system is intended for cryogenic destruction of tissue during surgical procedures It is indicated for use as a cryosurgical tool in a number of medical fields The system is designed to destroy tissue by the application of extreme cold temperatures 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 32 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Temperature sensor connector Emergency button 4 5 6 Rollers 7 Dewar positioning door 8 Handle plug holder 9 Foot pedal Not available in some regions e g China 10 Dewar storage cases The IceSense3 cryoablatio
8. 0 Genera SEMNE S cosi etai etui i sto nubem edet litu es om I lad 48 5 2 7 Preparing the system for treatment sssssseesesseeeeeeee enne eene 50 S235 Wredtmient5ele cuo o o terete eit bote eee oes ieee ee 58 0 9 Operational Stace oo iic oa o MER aedi ot od e RM alee ton o ose GOMA 62 JoL Premias eee E E 62 Then youmay Debo Ee OZITID kerora a nad Stet desi Sie iu 63 SUD MEE i2 el m E EET 63 2 949 ACUE Wy Al PIOCESS tases ut oec ebat aditus atte et asec ces Pauses esate atone mt 67 o IPOst Operational SLAP e Ssoiscieieddi ioter uite Le obese dud nee Sheeran 73 5 4 1 Removing the temperature sensor from tiSSUC cccccccceeeeeeeeeeeeeeceeeeeeeaes 73 5 4 3 Removing the cryoprobe from the cryohandle ssessssee 73 5 4 3 Disassembling the temperature sensor eeessssssssseeeeeeeeeeneeeeenennns 74 5 4 4 Exiting the IceSense3 cryoablation system treatment mode 74 I Uu Ire UE EESTI TRE TR MEE TN 75 5 9 1 JceSense3 M eryoablation system failure sseni e EE 75 5 5 2 IceSense3 cryoablation system touch screen failure s 76 O6 COMPUTER INTERPACE titel ed M reete volete moa ER UR Metis con ori vuota uos 78 OL The Te CHMIC Pan qe ee e a bee ucatoua a enacted Us 78 O2 Jseddino the SCEOC Dade tie io iene dot ee 78 G2 JPartsS ob Ne SCOE eosisesee buta eq M temi baD e b tuu e M ten babuit ud 78 6 9 SysleD MCS
9. 5 OPERATING THE SYSTEM This chapter explains how to use the IceSense3 cryoablation system and includes pre operational operational and post operational steps Note The User Manual describes how to operate the device with a percutaneous cryoprobe that requires ultrasound monitoring for its clinical application The device can be used with a blunt cryoprobe for topical indications that are performed without ultrasound imaging For topical applications the practitioner should follow standard clinical procedures that are not within the scope of this user manual The device can also be used for open surgical applications performed without the use of ultrasound imaging 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 e Patient and system preparation e Probe selection e System set up and pretest e Probe placement e Cryoablation cycle e End of procedure 5 2 Pre operational stages 5 2 1 Preparing the system for procedure 1 Ifa probe is still connected to the cryohandle remove and discard used probe from the handle 2 Remove previously used single use sterile sleeve from the cryohandle i Close the cryohandle with the cov
10. DSR3100000 rev K IceSense3 Confidential User Manual 4 INSTALLATION AND SETUP 4 1 Space and positioning requirements The work area for the unit should be prepared as per the dimensions described in the system specifications In order to guarantee sufficient ventilation always maintain a clearance distance of at least 0 5 meters 20 inches between the unit and walls or other objects that may obstruct air flow Adequate ventilation and air circulation are major considerations when working with liquid nitrogen 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 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 Warning The IceSense3 cryoablation system must be unpacked installed and tested by an IceCure Medical authorized technician only Caution After positioning the main chassis lock the front roller brakes Failure to do so may result in damage to the system or to other equipment in the clinic room 42 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual AN Caution Do not move the system when the dewar contains liquid nitrogen 4 3 Electrical requirements The IceSense3
11. EUT cc cicccssnssisussicasasavenndenncandieasteassanasheasdaeayentenscente 95 Figures Figure 1 Label 1 On Off mechanical button MLS1000002 Rev B 25 Figure 2 Label 2 Emergency Stop MLS1000003 Rev B eeeeeeeeeer 25 Figure 3 Label 3 Identification MLS3180001 Rev A eeeeeeeeeer 25 Figure 4 Label 4 Federal laws restriction MLS1000004 Rev B sees 25 Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C 26 Figure 6 Label 6 High voltage caution MLS1000006 Rev B eere 26 Figure 7 Label 7 Line voltage danger MLS1000007 Rev B esee 26 Figure 8 Label 8 Foot pedal MLS1000008 Rev B eeeeeeeeeennn 26 Figure 9 Label 9 Risk of Explosion MLS1000009 Rev B eene 26 Figure 10 Label 10 Single use probe MLP7000001 Rev F eeeeenee 27 Figure 11 Label 11 Single use temperature sensor MLT8000001 Rev F 27 Figure 12 Label 12 Liquid nitrogen dewar MLS1000001 Rev D 27 Figure 13 Label 13 Cold area MLS1000010 Rev B eeeeeeeennn 28 Figure 14 Label 14 Empty LN2 dewars MLS1000012 Rev A eese 28 Figure 15 Label 15 Applied parts MLS1000014 Rev A
12. Electromagnetic compatibility of medical electrical equipment See chapter 16 Manufacturer s Declaration of the EUT 2 8 Equipment classification e Electric shock protection Class Type BF 25 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e Protection against ingress of liquids ordinary equipment e 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 Identification with the manufacturer s name and address date of manufacture unit model and serial number and electrical specifications Label 4 CAUTION Federal USA law restricts this device to sale by or on order of a licensed practitioner Label 5 Read User Manual before use Label 6 CAUTION HIGH VOLTAGE Before working on this unit e Switch off power supply e Disconnect all plugs Label 7 DANGER Line voltage Label 8 Foot pedal Not available in some regions e g China Label 9 DANGER Risk of explosion if used in the presence of flammable anesthetics CAUTION To reduce risk of electrical shock do not remove cover Refer servicing to qualified service personnel Label 10 Single use probe Label 11 Single use temperature sensor Label 12 Liquid Nitrogen Dewar Label 13 COLD area Label 14 Empty LN2 dewars Label 15 Applied parts
13. Instructions If the problem persists contact technical support Figure 74 Error message format example e Pressing the OK button will indicate you have read this message and will dismiss this popup 80 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual AN Warning When the system shuts itself down due to an error contact IceCure Medical and describe the error message shown on the screen as precisely as possible Do not attempt to reuse the system before contacting IceCure Medical After reporting or making note of the error message switch OFF the mechanical ON OFF button and unplug the electrical cable 8l IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 7 ACCESSORIES 7 1 Cryoprobe 7 1 1 Single use sterile cryoprobe Distal Insertion part Plastic grip Serial number Shaft Probe tip N Figure 75 The cryoprobe components the figure is for illustration only Marks on cryoprobe shaft aid in determining the depth of probe insertion The first mark closest to the tip is thicker and represents the minimum insertion depth of the cryoprobe for a percutaneous procedure Before starting the freezing procedure the user must verify that this mark is fully inserted into the skin 7 2 The 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
14. K IceSense3 Confidential User Manual Millan sl lee Select Treatment WELET Protocols Show Last Treatment Settings 50 remaining procedures before maintenance Figure 68 The Main Menu screen To exit the system press on the Exit icon green arrow At the end of the last treatment of the day Switch OFF the mechanical ON OFF button and unplug the electrical cable Clean the system following instructions in section 8 1 and move the system to its storage location 5 5 System failures 5 5 1 IceSense3 cryoablation system failure When the IceSense3 cryoablation system detects an error the following will occur e A failure message will appear e The procedure will be aborted When the above occurs take action as follows 1 Write down the error message and number follow the system instructions 75 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Sensor out of expected range Do not use the system and contact technical support Error 911 Figure 69 System Fail example screen 2 Ifyou are in the middle of a cryotherapy procedure wait for passive thaw and then carefully remove the cryoprobe from the tissue 3 Detach the cryoprobe from the cryohandle ONLY after the dewar carriage has returned to the lowest position and 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 pressi
15. Label 16 Shipping Art Work There are additional labels inside the system that are not visible to the user These labels are intended for the technician 24 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual System Labels ON OFF MLS 1000002 Rev B Figure 1 Label 1 On Off mechanical button MLS1000002 Rev B Figure 2 Label 2 Emergency Stop MLS1000003 Rev B Ice Cure Medical LTD Haeshel 7 2nd Floor N Caesarea l P MN 38900 Israel Tel 972 4 623 0333 Fax 972 4 623 0222 www icecure medical cog Figure 3 Label 3 Identification MLS3180001 Rev A CAUTION Jo Federal lau restricts Ths device to sale Dy JY or the nthe rY OF a nnvysiclan kA I Figure 4 Label 4 Federal laws restriction MLS1000004 Rev B 25 IceCure Medical Ltd DSR3100000 rev K Confidential 2 Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C O 8 S00000LS IAN Figure 6 Label 6 High voltage caution MLS1000006 Rev B Figure 7 Label 7 Line voltage danger MLS1000007 Rev B Z MLS 1000008 Rev B Figure 8 Label 8 Foot pedal MLS1000008 Rev B Figure 9 Label 9 Risk of Explosion MLS1000009 Rev B IceSense3 User Manual 26 IceCure Medical Ltd Confidential DSR3100000 rev K IceSense3 User Manual IceSense3 eg 2 l iceSense3n lceCure se3 I eCure Cryoprobe REF FAP7200000 Rev C bs 14 April
16. Loading IceSense3 System Estimated time to complete 00 38 Figure 27 The system is loading screen Wait for the Main Menu screen to load Main Menu Select Treatment Manage Protocols Show Last Treatment Settings 50 remaining procedures before maintenance Figure 28 The Main Menu screen 3 4 2 System pre tests IceSense3 User Manual As the system uploads several pre tests are performed automatically in order to verify that the system is intact Several specific tests will be made upon visual inspection by the user following instructions on the graphic interface Each probe must be tested before use 40 IceCure Medical Ltd DSR3100000 rev K 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 During the freeze and the thaw cycles the system continues its internal check In case of system error the user will be instructed as to the appropriate solution 3 4 4 Warm step Warm is a process activated automatically by the system at the end of every automatic protocol or manually by the user at any time in the process During this process the cryoprobe tip is heated by warmed gas enabling fast and safe removal of the probe 4 IceCure Medical Ltd
17. Stop DUON sssri ier rky reniir cimus Pi Tux ra EEEE E OUT cima RU UE 22 2 5 2 Emergencies causing procedure halt ccccccccccccssssssseeeceeeeeesaeeseeeeeeeeeeeaaas 22 EO IT IDEE 23 PH CONN P 23 2 7 1 Compliance with international safety standards ssssssese 23 2 8 Equipment classification ssssssssssssesseseeeeeeeee nennen eene nnn nnne essi nnns 23 20 ACcompDamy ens 3bE IS scias secret ito EEE 24 2 9 1 Important Symbols and Labels eeeeeeeeessssssssseeeeeeeeeeeeennnnnnnn 20 2 OSXSTIENEDESCEIETICON eerie eem nce dhepemeonsums neis SUP eii tse n dope ue PU 32 S MEME OE 61 0 NEL Tm 52 Ao Cone DL Ol rop r O oer E d ap E n MURIS UA EM E UIN MUN 22 2 9 MO COPBIDORBODUS ea E us ces edi bet Ub US ates 32 2 9 M HS e E A E eee ree 33 35 2 2 Emergency 5top DUON assisen aiaia E e iair 33 amp Fo io am amp 29 410 oa 1 0 E E een re etre 34 E 8 016 0 C cl ot enn ree eee ee ee eee ee 34 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 200 GOryohandle and cryoprobe 45 ier IDEE Ee Untere aii Gee aan 35 9 550 Handle plis Nolde sientes etum EEA E E todo EEREN 36 oou JEOOLDeddlo 5b nome cuna uode lesan eue i tuac scare Io abc Lacu te i Sada I Sod 36 3 9 9 Temperature Sensor D iiuse addet p vente bueno ede ebbe pr eb veetebutu eate nb 36 399 DEWAR SIOLASS CASES edita
18. Warm to release the probe from the tissue and use the standard shutdown procedure Excessive use of the Emergency Stop button may damage the system Warning If a liquid nitrogen leak is detected during the cryotherapy procedure PUSH the Emergency Stop button immediately 3 3 3 Flexible hose The flexible hose joins the cryohandle to the siphon inside the chassis This permits nitrogen to flow from the main chassis to the probe Warning Do not pull the system by the cryohandle or flexible hose 3 3 4 Touch screen The touch screen is located on the top of the main chassis and allows for operating and monitoring of the system 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 computer interface and operating the system see Chapter 6 34 IceCure Medical Ltd Confidential DSR3100000 rev K IceSense3 User Manual Treatment using preset 1 3 Current step Skip Probe 013 DO NOT DISCONNECT 00 38 Protocol Elapsed Total Protocol Time 05 15 Freeze 00 00 Warm Manual Temp 18 7 Figure 20 The touch screen display during a cryoablation procedure 3 3 5 Cryohandle and cryoprobe The cryohandle is situated at the end of the flexible hose that projects through the upper area of
19. and discard the single use cryoprobe temperature sensor and sterile sleeve Warning For each new patient ensure that the previously used single use cryoprobe temperature sensor and sterile sleeve have been removed and discarded 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 21 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Do not pull the system by the cryohandle or flexible hose 2 5 Emergencies and errors 2 5 1 Emergency Stop button Warning Only push the Emergency Stop button when there is NO other choice Wherever possible use Warm to release the probe from the tissue and use the standard shutdown procedure Excessive use of the Emergency Stop button may damage the system Warning If a liquid nitrogen leak is detected during the cryotherapy procedure PUSH the Emergency Stop button immediately 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 Warning When an error message is displayed and a procedure is aborted remove the probe ONLY after you are requested to do so by the
20. and is not essential for normal functioning of the system It serves as an alternative to the Action button on the cryohandle To use the foot pedal Not available in some regions e g China connect it to the console by plugging its cable into the footswitch connector located on the back panel 7 3 The temperature sensor The temperature sensor is a single use external accessory that can be connected to the main chassis if the user chooses to measure target tissue temperature during cryoablation To use the temperature sensor connect it to the panel connector on the right upper corner of the chassis according to instructions detailed in section 3 3 7 Temperature sensor 82 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 8 SYSTEM MAINTENANCE 8 1 General cleaning Warning Do not allow any liquid 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 flexible hose and touch screen and carefully clean the flexible hose and the cryohandle with a damp cloth All single use devices are considered to be medical waste and must be disposed of in accordance with medical waste laws and hospital standards Sharp objects such as the cryoprobe and temperature sensor must be disposed of in a sharps container Following a cryosurgical proce
21. deals with danger to equipment and data Caution It is dangerous for equipment and data to do this 2 2 Basic safety principles All the safety issues explained in this manual are grouped within the following areas of responsibility 2 2 1 Ownership Warning U S federal law restricts this device to sale by or on order of a physician 2 2 2 Qualification Warning Any procedures using this system must be performed by licensed practitioners or board certified doctors who are trained and experienced in the use of this system 10 A A A A A A IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning 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 Warning Never allow untrained personnel to operate the IceSense3 cryoablation system Warning Never enter the Technician mode screen Only an IceCure technician or authorized representative is allowed to use the technician mode for maintenance or repair of the system 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 2 2 3 Training Warning Do not use this system if you have not been adequately trained 2
22. extinguisher in the vicinity of the unit is recommended 2 4 2 Opening the dewar compartment Caution Never open the dewar compartment while running a cryoablation procedure Do not use the systen while the dewar compartment is open Warning Do not transfer a dewar with Liquid nitrogen unless it is covered with a lid 18 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Caution Follow the specific instructions on how to fill and transfer a dewar as described in section 5 1 6 1 Dewar 2 4 3 Voltage and power ratings Caution Verify that the IceSense3 cryoablation system complies with the local voltage line 115 VAC or 230 VAC 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 Maintenance of liquid nitrogen dewars should be performed by authorized personnel only Warning 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 Standard guidelines for safe handling and storage of liquid nitrogen are available from the supplier and must be carefully observed The following is a list of general safety points that should be fol
23. functional problem occurs as represented by one of the pictures press on the relevant picture Follow system instructions until you are required to safely remove the probe from the cryohandle You will then be returned to the Main Menu screen Check that the dewar is full and replace the probe and start again If the problem recurs do not proceed with treatment Turn off the system and contact IceCure Medical Choosing Success will load the treatment selection screen If for any other reason you decide to stop the procedure press Cancel Follow system instructions until you are required to safely remove the probe from the cryohandle You will then be returned to the Main Menu screen Warning In case of frost on shaft if possible start active Warm If not wait for passive Thaw In both cases use skin protection techniques Warning During pre test portions of the cryoprobe including the plastic cover that is located near the cryoprobe handle other than the freeze zone may due to malfunction become cold If unwanted freezing occurs stop the pre test process by pressing Cancel 5 2 8 Treatment Selection The sy stem 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 Type of treatment is determined by the number and duration of freeze and thaw cycles 58 IceCure Medi
24. must be IN THE TARGET TISSUE BEFORE starting the freeze treatment Warning Do NOT allow the freeze process to start before the probe tip is actually within the target tissue Warning The surgeon must hold the cryohandle for the duration of the cryoablation procedure 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 16 gt gt bP b DD IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Before removing the cryoprobe from the tissue make sure that the freeze effect has been deactivated so that the probe can easily be removed from the tissue Do not force removal of the cryoprobe from the tissue as it might increase the risk of hematoma Continue the Warm step or wait for passive thaw until the cryoprobe can be withdrawn easily 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 Warning DO NOT push the warm button when the cryoprobe is not within the target tissue as skin burns could occur and not before the freezing protocol is completed unless you want to shorten the procedure due to clinical judgment Warning Never detach the cryopr
25. original sponge lid supplied with the dewar Liquid nitrogen containers should always be stored in an upright position Tipping the container or letting it lie on its side can result in spillage and may damage the container Dropping the container or subjecting it to severe vibration may damage the vacuum insulation system Transfer liquid nitrogen with care Spilling and splashing are the primary hazards of transferring liquid nitrogen from one container to another NEVER overfill the containers Filling above the specified level is likely to produce spillage when the lid is replaced Transportation of liquid nitrogen must always be done in the original container and in accordance with local laws and safety rules Do not attempt to dispose of residual or unused quantities of liquid nitrogen For safe disposal contact your supplier For emergency disposal discharge slowly to the atmosphere in a well ventilated room or outdoors If spilled liquid nitrogen causes a cloud to form the room must be evacuated and ventilated immediately Anyone experiencing headache dizziness difficulty breathing or other symptoms of hypoxia should receive immediate medical attention 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 Warning Before beginning a procedur
26. process To prevent injury cryoprobes must be closely observed during use for signs of unwanted freezing Warning You must NOT allow the freeze process to start before the cryoprobe tip is actually within the target tissue Warning The practitioner must hold the cryohandle for the duration of the cryoablation procedure 63 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 5 3 2 1 Manual freeze mode Choosing the Manual freeze mode will open the treatment screen for manual mode as show in Fig 45 e To activate the freeze cycle press the Action button on the cryohandle and hold it for one second or press the Freeze icon on the screen The BLUE LED will light up around the Action button Treatment using Manual Mode Current Step Protocol Elapsed 00 00 Ready n 9 Freeze Back Probe 013 DO NOT DISCONNECT Temp 100 Figure 54 Manual Mode screen press on Freeze to start the freeze cycle Treatment using Manual Mode Current Step Protocol Protocol Elapsed Time 00 00 Freeze Freeze zm Elapsed 00 58 D La E Thaw Warm Probe 013 DO NOT DISCONNECT Temp 100 Figure 55 Freeze screen in Manual Mode e 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 64 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential
27. red circle icon see below figure Figure 33 The active Warm button as displayed on screen 5 2 5 Show Last Treatment The last treatment will be displayed by choosing Show Last Treatment icon on the Main Menu screen This will open the next screen Date Jan 24 2010 Time 10 54 AM Treatment Mode Preset Probe IceSense 13 Main Menu Figure 34 Last Treatment screen In this screen you can see details of the last procedure that was performed including date time treatment mode and duration of treatment 47 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 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 27 I WAT l ae Allele Prepare For Treatment Edit Presets Show Last Treatment Settings Ad 50 remaining procedures before maintenance Figure 35 Activating the Settings option from the Main Menu screen Choosing the Settings button green arrow will load the settings screen with four icons representing different options Pressing any of these icons will open a new settings screen pertaining to that option Settings Change Technician Export Workflow mode Log Back y 50 remaining proceedures before maintennce Figure 36 The Settings screen 48 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential Us
28. screen The BLUE LED will light up around the Action button The start icon will change to a Skip icon The skip icon enables the user to skip from the current step in the cycle to the next step as preprogrammed Within a given protocol if you want to increase decrease the preprogrammed time of a cycle when the cycle has already started use the icons on the left side of the screen to add subtract 15 seconds with each push At the end of the last freeze step in automatic mode the Warm step will begin and the Warm screen will be displayed You can interrupt the automatic mode AT ANY TIME by pressing the Manual mode button on the screen o If you do so proceed as explained in section Manual freeze mode press the Action button on the cryohandle to move from freeze to thaw and monitor the process under ultrasound 66 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Treatment using preset 1 30 4 30 current Step otal Protocol Time 07 30 00 58 Skip Manual Connected Probe IceSense 13 Figure 58 Freeze screen in Automatic mode During the preprogrammed procedure the system provides information regarding treatment progress e The left side of the screen displays the Current Step freeze thaw or warm cycle and time left for this cycle e The right side of the screen displays information concerning the overall Protocol including total protocol time time elapsed protocol f
29. the longest dimension of the target tissue 2 n percutaneous procedures insert probe using ultrasound guidance e Confirm longest dimension of the target tissue e Perform a 3 mm skin incision for example using 11 blade 62 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Position the tip of the cryoprobe at the distal end of the long axis of the target tissue and not more than 5 mm beyond 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 In percutaneous procedures it must be completely inside the tissue to avoid skin burns The rest of the marks indicate depth of probe insertion each mark equals one centimeter with distinctive markings at 5 and 10 cm as shown in Fig 44 Figure 53 Markings on the probe Main marks indicate safety thick mark on left 5 cm slightly thick third mark from the left and 10 cm double mark in circle Then you may begin freezing 5 3 2 Freeze Cycle Selecting the type of treatment Manual or Automatic is discussed in section 5 1 7 Warning Portions of the cryoprobe including the plastic cover that is located near the cryoprobe handle other than the freeze zone may become cold and cause tissue damage If unwanted freezing occurs immediately stop the freezing
30. the vicinity of equipment marked with the following symbol P NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed 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 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual relocating the model IceSense3 Cryotherapy product b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 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
31. 00 rev K IceSense3 Confidential User Manual 1 OVERVIEW 1 1 Introduction IceSense3 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 IceSense3 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 IceSense3 cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures The lceSense3 cryoablation system is indicated for use as a cryosurgical tool in the fields of general surgery including breast tissue dermatology thoracic surgery gynecology oncology proctology and urology including kidney tissue The IceSense3 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 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 cryoa
32. 120 08 12 2011 08 12 2012 ems GADE Ice Cure Medical LTD Quantity 1 Haeshel 7 2nd Floor Caesarea 38900 Israel Tel 972 4 623 0333 Fax 972 4 623 0222 www icecure medical com Caution Federal law restricts this device to sale by or on the order of a physicians MLT8000001 Rev F Figure 12 Label 12 Liquid nitrogen dewar MLS1000001 Rev D IceCure Medical Ltd DSR3100000 rev K Confidential A aay OLOO00LS Tii 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 V 9 amp VLOOOOLS IW 1060 hPa 500 A Figure 16 Label 16 Shipping Art Work IceSense3 User Manual 28 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 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 Symbol Meaning Caution Applied parts gt gt Class 1 Serial number Manufacturer Date of manufacture Do not reuse Use by Date Catalogue number Do not resterilize 45g ern E s STERILE Sterilized using ethylene oxide 20 IceCure Medical Ltd D
33. 2 4 Clarity Warning Do not use this system until you have read the User Manual in its entirety and fully understand its contents While every effort has been made to make this User Manual comprehensive certain sections may be unclear or difficult to understand depending on the user s background and experience Do not use this system if there is any instruction direction precaution or note which you do not understand or which is unclear If necessary contact an authorized IceCure Medical representative for further information and clarification before using the system 11 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 2 5 Clinical assessment Warning Practitioners should be aware of the possibility of mammographic findings at the site of a cryoablated fibroadenoma Practitioners should enquire if a patient has a history of cryoablation Warning Exercise caution when treating patients who have had previous difficulty with surgical procedures or local anesthesia Warning Safety and effectiveness of the IceSense3 cryoablation system in pregnant women has not been established Physicians should exercise caution when using IceSense3 cryoablation system in pregnant women Caution 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 W
34. 2015 ep DADC Eun Ice Cure Medical LTD Haeshel 7 2nd floor Caesarea 38900 Israel Tel 972 4 623 0333 Size 13 Fax 972 4 6230222 Quantity 1 ud d www icecure medical com Caution Federal law restricts this device to sale by or on the order of a physician MLP7000000 Re G i a a ET eas Sia 13 Cryoprobg Sizei 08 SN J13 22777772 20130417 sN o3 18058 20110508 l 5 May 2013 Q M 25 May 201 a a 38900 Israel PERO eer eee eet Ice Cure Medical LTD Haeshel 7 2nd floor Caesarea Tel 972 4 6230333 Fax 972 4 623 0222 Figure 10 Label 10 Single use probe MLP7000001 Rev F IceSense3e 7 IceCure Temperature Sensor FAT8000000 Use only with IceSense3 cryogenic device 20111120 08 12 2011 QAO C Cu iS 08 12 2012 Ice Cure Medical LTD Quantity 1 Haeshel 7 2nd Floor Caesarea 38900 Israel Tel 972 4 623 0333 idum Fax 972 4 623 0222 wwwW icecure medical com Caution Federal law restricts this device to sale by or on the order of a physician MLT8000001 Rev G Figure 11 Label 11 Single use temperature sensor MLT8000001 Rev F IceSense3 gh IceCure Liquid Nitrogen Dewar PMT1000101 20110913 C UA A Y ae sufficient for one Oxygen Depleting procedure onlyE Caution Handle with care fa 9M LOOOOOLSTW IceSense3 4 7 IceCure Temperature Sensor FAT800000 Use only with IceSense3 cryogenic devicg 20111
35. 5 REPORT CUSTOMER COMPLAINT Send to IceCure Medical Inc 10000 Cedar Ave MS 13 2 floor Cleveland OH 44106 icecuresupport icecure medical com Toll free 888 516 7389 Tel 216 929 5153 Fax 216 929 5143 OR IceCure Medical Ltd HaEshel 7 2 floor Southern Industrial Park Caesarea 38900 Israel info icecure medical com Tel 972 4 623 0333 Fax 972 4 623 0222 IceSense3 User Manual MedNet GmbH Authorized Representative of IceCure Medical Ltd Borkstra se 10 48163 M nster REP Germany Tel 49 0 251 32266 0 Fax 49 0 251 32266 22 94 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 16 Manufacturer s Declaration of the EUT Guidance and manufacturer s declaration electromagnetic emission for all EQUIPMENT AND SYSTEMS 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 RF emissions The model IceSense3 Cryotherapy product CISPR 11 uses RF energy only for its internal function Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B Harmonic emissions EN 61000 3 2 Class A Voltage fluctuations flicker emissions E
36. 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 following message Connect a USB flash drive and press OK Press OK to export the log file to the USB drive Press Cancel to return to Settings screen If export fails the message in the status area reads Export failed make sure a flash drive is connected Before using a flash disk check that it contains enough free space for file storage 5 2 6 4 Set time This screen allows you to set the date and time Date and Time Properties Date amp Time Time TEE Date Bos 6 7 8 11 12 13 14 15 16 19 20 21 22 25 6 2 28 28 11 sz 01AM Current time zone Jerusalem Standard Time Figure 38 The Windows Date and Time Properties screen Set the date and time according to your time zone and approve it by clicking Apply in the right lower corner of the screen In order to complete the process restart the system Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure 5 2 7 Preparing the system for treatment The system will guide the user through a system preparation process following the system instructions is essential Preparation includes technical steps and tests to make sure the system is ready for a cryotherapy procedure It includes 1 Dewar refilling and repla
37. 7 24 inches Depth 70 cm 27 56 inches Width 50 cm 19 68 inches 150kg 220 240 VAC 7A 50 60 Hz single phase 0 100 psi Boiling point 196 C thermocouple type K 10 C 440 C 50 F 104 F 0 C 70 C 32 F 158 F O up to 80 not condensing at room temperature O up to 9096 not condensing 700 hPa 1060 hPa 500 hPa 1060 hPa 196 C to 40 C Power supply 24 V Pressure range O 1 145 psi Accuracy 196 Repeatability lt 0 1 89 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 12 TEMPERATURE DISTRIBUTION ANALYSIS INHOMOGENEOUS 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 The model that was used is a theoretical model with the following characteristics and assumptions Homogenous medium The temperature cold finger surface is T cf 170 C The temperature of the homogenous medium is 37 C T medium 37 C A visible ice ball is created at the 0 C isotherm Exponential temperature distribution according to eee pep T x T medium T medium T cf exp a x 37 207 exp a x Where X is the radial distance from the cold finger With these assumptions calculations show Calculation of Diameter of a 0 C Calculation of Estimated
38. ED does not light up Ice formation on the flexible hose Nitrogen leaks from cryoprobe cryohandle or system during the cryotherapy procedure Unreasonable temperature readings of temperature sensor DSR3100000 rev K Probable Cause Dewar is not in place or is blocked by an unknown object System identifies wrong or double use of the cryoprobe Faulty microswitch Faulty icon or operator misuse Burned out LED or it should not be lighting up at given time Low temperature causes moisture to form ice particles Cryoprobe is not well connected or pipes are faulty Temperature sensor or system malfunctions IceSense3 User Manual Action Try tilting the dewar and pulling it out using reasonable force If dewar cannot be removed close the door and call IceCure Medical service Verify that the number you entered matches the one on the cryoprobe and the package If S N is correct reenter it into the system If the message reappears change the cryoprobe or call IceCure Medical service Ensure that the probe is fully inserted can t screw it any more with reasonable force If message still appears change cryoprobe If the problem persists contact IceCure Medical service Try pushing the icon again It is only activated if pushed for 1 second Check the user manual to ensure that you can indeed use the icon in the present screen If the problem persists contact IceCure Medical se
39. K IceSense3 Confidential User Manual Safe transportation When moving the system from one location to another the Dewars should be empty 3 4 Operational details This section describes the operational actions of the IceSense3 cryoablation system that support the functional operations described in Chapter 5 e Order liquid nitrogen in advance based on projected case load e Industrial grade liquid nitrogen should be delivered to the user s site in a standard cryogenic dewar e Follow standard guidelines for the safe handling and storage of the dewar 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 e Care must be taken when filling the system dewar e Standard guidelines for safe handling and storage of liquid nitrogen should be followed These guidelines are available from the supplier 3 4 1 Starting the system Before turning on the system confirm the following conditions e Previously used cryoprobe temperature sensors and sleeves have been removed and the system has been cleaned of any residue and dried off e The system is connected to the electrical outlet To switch the system ON turn on the mechanical button at the back of the system the touch screen will turn on and the following screen will appear 39 IceCure Medical Ltd DSR3100000 rev K Confidential
40. N 61000 3 3 Complies 95 IceCure Medical Ltd DSR3100000 rev K IceSense3 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 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 Immunity test IEC 60601 test Electromagnetic environment guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the model IceSense3 Cryotherapy product including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF EN 3 Vrms Recommended separation distance 61000 4 6 150 kHz to 80 TNF MHz d P 80MHz to 800 MHz Ei Radiated RF EN 3 V m 61000 4 3 80 MHz to 2 5 d NP 800 MHz to 2 5 GHz l GHz where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m b Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in
41. SAL CS eee T e a onesies 79 Gol Saus MESSI E a a a M d ET Id 79 6032 Wat MESSASS aae taeda ie eouenenin in eenanendats 79 0 9 TE TOR TICS SIDE Suocansce te Acetate AE Sai cu Td ba atomi DU DER che c a anata 80 T S6 2 u9hlisct EE 82 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual LE EOOD e eRe ne ee ee eee 82 JJ Sumeledsesterile CIV ODI ODE sasssa o e EE 82 Te WANG MOOU CGA shee sates eect oe eect cca E 82 Ao AME TEMP erat S GEMS OE oacrenaececere ye E E anere eevee 82 Be MAINTENANCE sisirin iai aiiai hni is eshini 83 ee DIE 83 2289 7 2 E Epem i O 83 S MEN COGS STV 1G TETTE T 84 7 TROUBLE HOOTHN G 1 2 2 etude N its senses N aeons 85 MNEMEGV I CNET 85 92 Troubleshootine uide i ora seaageret chet eosteyaa sans otsousovasetasdeteoeosancnastactsouvaaciestetegorse 85 10 IceSense3 cryoablation system Step by Step procedure sssss 88 I YS TEM SPECIFICATIONS icveccococsedsseosurtensnsseceesaevensmenewecesceumenssbonecessaoretcontesetesaens 89 12 TEMPERATURE DISTRIBUTION ANALYSIS INHOMOGENEOUS MEDIUM 90 13 LIMITED WARRANTY CERTIFICATE eeeeeeeeeeeeeeeeee nennen 02 14 CUSTOMER COMPLAINT EORJID itoiccucsapecexsetet sodes ehe scueievteGues pu scusa ob eode sepwscusd pss 93 15 REPORT CUSTOMER COMPLAINT i eeeeeeeeeseesesessessesseesssssssesesssseeseseeeeees 94 I6 Manufacturer s Declaration of the
42. SR3100000 rev K IceSense3 Confidential User Manual Symbol Meaning LOT Batch code Contains sufficient for lt n gt test X L 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 Electrical and electronic equipment contain hazardous substances which when disposed of incorrectly may leak into the ground This can contribute to soil and water pollution which is hazardous to human health and endangers wildlife Therefore such equipment must not be disposed of in landfill sites or incinerators Contact your local authority or place of purchase regarding responsible disposal recycling Fragile handle with care Do not use if package is damaged Cold area Consult instructions for use OOH Oxygen depleting Oxygen depleting 30 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Symbol Meaning This side up Lr Authorized representative in the European community CE mark mandatory conformity mark for products placed on the market in the European Economic Area 1060 hPa 500 a Transportation and storage atmospheric pressure limits 90 0 Transportation and storage humidity limits 70 C 158 F 0 C 32 F Storage temperature limits
43. User Manual IceSensee Treatment using Manual Mode 0 1 0 1 9 Freeze Warm Probe 013 DO NOT DISCONNECT Temp NA Figure 56 Thaw screen in Manual Mode e You can continue to move between cycles by the same method e To end the procedure press the Warm button on the cryohandle or the Warm icon on the screen Freezing will cease and the Warm screen will open The BLUE LED on the cryohandle will turn off Treatment using Manual Mode Probe 013 DO NOT DISCONNECT Temp NA Figure 57 Warm screen in Manual Mode During the manual procedure the system provides information regarding treatment progress 65 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual The left side of the screen displays the Current Step freeze thaw or warm cycle and time elapsed for this specific step The right side of the screen displays information on the entire Protocol as total elapsed time and treatment format If you perform more than 3 consecutive freeze thaw cycles the right side will only display the last 5 actions due to screen size limitation 3 freeze thaw cycles 5 3 2 2 Automatic freeze mode Choosing one of the suggested protocols from the Treatment Selection screen will open the automatic protocol screen To activate the freeze thaw preprogrammed cycles press the Action button on the cryohandle and hold it for one second or press the Freeze icon on the left lower corner of the
44. Wait for passive Thaw Warning Before removing the cryoprobe from the tissue make sure the freeze effect has been deactivated and the cryoprobe can be easily withdrawn Never use excessive force to extract the cryoprobe Warning AN DO NOT push the warm button when the cryoprobe is not within the target tissue as skin burns could occur and not before the freezing protocol is completed unless you want to shorten the procedure due to clinical judgment 5 3 4 Replace the dewar during a cryo procedure In case you intend to do a long treatment that will freeze over 14 minutes you will need to 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 In case you decide to replace the dewar be careful not to move the cryoprobe into the tumor as in all thaw period so you keep the location of the probe Control the process under Ultrasound or any other imaging system e The system will automatically ask if you want to replace the dewar figure 60 below Treatment preset O 7 00 05 00 07 G0 ceSense3 A Current step Protocol Elapsed Total Protocol Time 19 00 EKEMS S Freeze 07 00 00 03 Freeze 00 00 15 04 56 4 T Replace Dewar Cancel e Probe 13 DO NOT DISCONNECT Figure 60 Replace dewar option question 69 IceCure Medical Ltd DSR3100000 rev K IceSense3 Con
45. al Ltd DSR3100000 rev K IceSense3 Confidential User Manual Loading IceSense3 System Estimated time to complete 00 38 IceCure Figure 30 The system is loading screen Wait for the Main Menu screen to load Make sure the time is set according to local time zone before executing a cryotherapy procedure Main Menu Prepare For Treatment Edit Presets Show Last Treatment Settings 90 remaining procedures before maintenance wv Figure 31 The Main Menu screen 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 46 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 5 2 4 1 Using the cryohandle e Action button this is a blue button on the inner side of cryohandle It activates deactivates the freeze cycle and confirms actions displayed on the screen with a blue circle icon Figure 32 The Action button as displayed on screen several of the options e Light status indicator This is a BLUE LED which lights up around the Action button indicating the activity of a freeze cycle e Active warm button this is a red button on the cryohandle It activates the active warm process for fast and safe probe extraction from the target tissue The active warm process can also be activated from the screen when displayed as a
46. and the model IceSense3 Cryotherapy product 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 between portable and mobile RF communications equipment transmitters and the model IceSense3 Cryotherapy product as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output of transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 977
47. arning 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 While experience has shown that the system is useful for certain applications in cryosurgery no representation or warranty is made that the system is useful for any specific person or condition Warning For patients with breast implants you must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant 12 IceCure Medical Ltd DSR3100000 rev K 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 Warning Temperature sensor insertion and navigation within tissue MUST be done under guidance of an appropriate imaging device 2 2 6 Installation and setup Warning The IceSense3 cryoablation system should be operated in an adequately ventilated room Failure to do so may result in risk of suffocation due to increased levels of nitrogen in the room 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 equipmen
48. blation system may be used with an ultrasound device to provide real time visualization of the cryosurgical procedure Urology e The system may be used to ablate prostatic tissue e The system may be used to ablate kidney tissue including renal cell carcinoma e The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Oncology IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e The system may be used for ablation of cancerous or malignant tissue e The system may be used for ablation of benign tumors e The system may be used for palliative intervention Dermatology e The system may be used for the ablation or freezing of skin cancers and other cutaneous disorders Gynecology e The system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia General Surgery e The system may be used for the 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 e The system may be used for the destruction of warts or lesions e The system may be used for the palliation of tumors of the ora
49. cal Ltd DSR3100000 rev K IceSense3 Confidential User Manual Treatment Selection Select a preset protocol or Manual mode N 2 A Freeze Freeze Freeze Preset 01 Preset 02 Preset 03 Preset Preset Preset Preset Preset Preset Preset Manual Edit Presets Main Menu Probe 013 DO NOT DISCONNECT Figure 47 Treatment Selection screen 5 2 8 1 Automatic freeze mode Each preset protocol icon displays the number and duration of freeze and thaw cycles as shown in Fig 38 Select a protocol by pressing the desired icon on the touch screen A procedure screen will open After inserting the cryoprobe into the tissue you will be able to start the cryoablation procedure 5 2 8 2 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 llla iva21 igi E i lein oln Select a preset protocol or Manual mode Freeze CREAN 03 00 03 00 Prepare For 0t Treatment Freeze Preset 01 Preset 02 Preset 03 Edit Presets Freeze Freeze Show Last Treatment Freeze Preset Preset Preset Settings Manual Edit Presets Probe 013 DO NOT DISCONNECT Figure 48 Define a treatment protocol by choosing Edit Presets on the Treatment Selection screen green arrow or in the Main Menu screen yellow arrow 59 IceCure Medical Ltd DSR3100000 rev K I
50. ceSense3 Confidential User Manual Choosing either option will open the Preset Setup screen and you will be able to add a specific protocol by pressing one of the empty Preset icons or edit an existing protocol by pressing one of the pre defined Preset icons ense Z Ere ore Preset 01 Preset 02 Preset 03 Preset Preset Preset Preset Preset Preset Preset Back Probe 013 DO NOT DISCONNECT Figure 49 Editing an existing protocol green arrow or adding a new one yellow arrow 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 Preset screen will load 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 3 Save the protocol by pressing the Save icon 60 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Edit Preset 7 o 2 oro MENMN Freeze Save Cancel Delete select the number of freeze cycles and set the times Figure 50 Steps for adding a protocol 5 2 8 4 Editing a protocol If you choose to edit an existing protocol the edit preset screen will load The process is very similar to that of adding a new protocol EditPreset A Freeze Steps Total Time 2 07 00 Freeze 02 00 03 00 Freeze 02 00
51. cement 50 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 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 I WAT l oe Allele Prepare For Treatment Edit Presets Show Last Treatment Settings 00 remaining procedures before maintenance Figure 39 Preparing the system for treatment by pressing Prepare for Treatment green arrow on Main Menu screen 5 2 7 1 Dewar Prepare the dewar for treatment as per the following instructions and as detailed on the system screen see Fig 40 Filling the Dewar Open the dewar compartment door and take out the dewar Carefully cover it with the sponge lid Caution Follow the detailed instructions on open the dewar storage when you want to replace a dewar e The dewar must be filled prior to each procedure and is never stored with liquid nitrogen inside the system at the end of the working day e For proper handling in order to ensure safety please follow the cryogen supplier instructions 51 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Liquid nitrogen may cause serious injury or burn if handled improperly Local laws and safety rules regarding liquid nitrogen dewars should always be observed Maintenance of l
52. cryoablation system is pre wired for the local line voltage as specified by the user Accordingly the unit will require a line supply of 220 240 VAC 50 60 Hz 7A single phase The unit is grounded through the power cable that is plugged into the wall power outlet Good grounding is essential for safe operation The main circuit breaker for the unit is 10 A The circuit breaker is located in the main chassis 4 4 Shipment components The IceSense3 cryoablation system is packed and shipped in separate units as follows 4 5 Main system assembly User manual One or more empty dewars Accessories foot pedal Not available in some regions e g China single use probe kit temperature sensors Sterile sleeves and sterile cover for the cryohandle holder to be ordered separately by the user Liquid nitrogen not supplied with the system to be ordered separately by the user Disinfecting wipes not supplied with the system to be ordered separately by the user Installation Warning The IceSense3 cryoablation system must be unpacked installed and tested by an IceCure Medical authorized technician only and in accordance with the unpacking instructions manual Any damage to the container or to the unit discovered upon unpacking installing or testing should be immediately reported to your IceSense3 cryoablation system distributor 43 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual
53. dure it is recommended to wipe the pedal Not available in some regions e g China with a damp cloth and warm soapy water to remove visible soil Dry it with a clean cloth or with forced air and wrap it in another clean cloth until disinfecting it 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 Take special care to avoid spilling liquid onto the system Check the unit for any remaining blood or tissue In case these remnants are detected wipe the infected area with gauze Pads soaked with 70 alcohol Verify that no visible remnants remain Wipe the initially cleaned area with approved Medical professional surface disinfecting wipes and dry it in air At the end of the day carefully dry all items and store the system in an appropriate place 8 2 Sterility Warning The cryoprobes and the temperature sensors are single use and are supplied in single use packaging Never reuse a single use cryoprobe temperature sensor or sterile sleeve Reprocessing single use device like the cryoprobe temperature sensor could affect the mechanical or performance or microbiological properties of the product The sterile sleeves and covers are single use and are supplied by IceCure Medical in single use packaging The sleeves are used to cover the flexible hose up to the cryoprobe and to cover the to
54. e Peers tration SCree IN aceiren nar a T O E sarees 54 Figure 44 Cryoprobe COnmectrOD SCECOD ee 1e Erba ORE UR LEE AER atado pro Raid 55 Figure 43 Punctional test Seteeltc nee oe eene Eu eto E EE Eee pee dus 56 Figure 46 Functional test visual inspection screen eese 57 Fionre 477 Treatment 5e lecHOn SETE rin iat Poe EE 59 Figure 48 Define a treatment protocol by choosing Edit Presets on the Treatment Selection screen green arrow or in the Main Menu screen yellow arrow eeeeeeessse 59 Figure 49 Editing an existing protocol green arrow or adding a new one yellow arrow M C S 60 Froure 20 Steps Tor addin 3 prOfOCOL o e ett E ini oH tie et ito ets 61 Figure dl Edit Preset scio li duco RN ibi at eie e NE a NE 61 Figure 52 Choosing the Manual Mode option green arrow cceeccceccceeeeeeeeeeeeeeeeeeeeees 62 Figure 53 Markings on the probe Main marks indicate safety thick mark on left 5 cm slightly thick third mark from the left and 10 cm double mark in circle 63 Figure 54 Manual Mode screen press on Freeze to start the freeze cycle 64 Figure 55 Freeze screen in Manual Mode issn cds evt sS RE SUED Se obe at deseo 64 Figure 56 Thaw screen in Manual MOde rui reet notae e eon trenta opea A 65 Figure 7 Warimscreen 1n Manual Mode 2522 terre E N TE 65 Figure 58 Freeze screen in Auto
55. e ee ree ene ert err pee mere tee ee ee eee 7 IMS E iecore dii m UU TT 7 e MEE Idi IE TRTTNS TEM 8 Lo bors 6 76 O ae eR nee ee ne eee 9 IFTMEE S ICldiciN een 9 2 goi Or T seceeaetane 10 Zid Vy AMUN IN CAM ONG ecemeusoncsb uerum suspicor E T Suse pav ESO ecc DRE anor T HD 10 22 Basic UON PRICES PITE TE TOIT ETT 10 PM MEEG ino 10 2E EE OAERTN 10 DD Vc si TE 11 p MC a E E E ee 11 2 2 3 CAME AAS SE e eorn rE e E E E E 12 220 WS ta and SE LDUD ose teronei quii o es otevig doct roD cen ceagesestateataeccgsseedeeteaee 13 2254 PROC HS aaa ehcp sets te etches E SU IUNIO E MU 14 2 9 Operdunb Wario sesser n n A E EE E NE E ET Ea r a 16 Die EONO E E E 18 2 4 1 Danger explosion and fire hazard cecccccccccccecesssesseeceeeeeeeseeeseeeceeeeeeaaas 18 2 4 2 Opening the dewar compartment s ssseseeeseseeeeeeeee enne eene 18 2 4 3 Voltage and power ratings Lose ecoo s qecee orsa ben orar gue e eve abu aree guerra a aan roro uo ee Rab 19 2b ANG nitro ti dle D coseaemecser od uou uc istae uide puc esadiuone esten Ene bX Meo veU DNE EINE 19 Zo Bora NAAN conderet E E E 20 LO CO A E E E crete 21 DA O e M 21 2 4 8 Mechanical handling of flexible hose and cryohandle 21 23 Emetsencics and CEOS va cisssawatensnetcneasdenadenotoastiesedouneeaetsteteseleaadanioectasebeasatasrseetesalss 27 234 Em rsency
56. e on a new patient the dewar MUST be completely refilled and placed in the system as described in section 5 1 6 1 of this manual 2 4 5 Burn hazards The Cryoprobe tip can reach very low temperatures Warning Portions of the cryoprobe including the plastic cover that is located near the cryoprobe handle other than the freeze zone may become cold and cause tissue damage If unwanted freezing occurs immediately stop the freezing process To prevent injury cryoprobes must be closely observed during use for signs of unwanted freezing Warning Portions of the cryoprobe including the plastic cover that is located near the cryoprobe handle other than the freeze zone may become cold and cause tissue damage If unwanted freezing occurs stop the pre test process by pressing Cancel 20 A IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 4 6 Grounding Warning To avoid risk of electric shock this equipment must only be connected to a supply main with protective earth 2 4 7 Sterility Warning The cryoprobes and the temperature sensors are single use and are supplied in single use packaging Never reuse a single use cryoprobe temperature sensor or sterile sleeve Reprocessing single use device like the cryoprobe temperature sensor could affect the mechanical or performance or microbiological properties of the product Warning After finishing the surgical procedure on a patient remove
57. emove the probe from the cryohandle You will then be returned to the Main Menu screen Contact IceCure Medical technical service If the internal test is successful the system will display the visual inspection screen You will be prompted to inspect the following o Thecryoprobe tip make sure a small ice ball forms o Thecryoprobe shaft check that there is no ice on it o The saline check that there are no bubbles o The connections make sure there is no foam i e no leakage or any unusual appearance e llustrations of potential functional failures will appear on screen Please refer to these illustrations while inspecting the cryoprobe Mrepare for Treatment rope o N Bubbles a Frost on Shaft Cancel Probe 013 DO NOT DISCONNECT Figure 46 Functional test visual inspection screen e fa functional problem occurs or there is any unusual appearance such as frost on the plastic cover near the cryohandle etc and it is not represented by one of the Illustrations press Cancel Follow system instructions until you are required to safely remove the probe from the cryohandle You will then be returned to the Main Menu screen To start again Check that 57 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual A 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
58. er Manual 5 2 6 1 Change workflow IceSense3 cryoablation system supports 2 alternative workflows allowing the user to select a treatment protocol before preparing the system filling Nitrogen connecting probe and testing it or to prepare the system first and then select a treatment protocol To set the preferred workflow press Settings in the main menu followed by Change Workflow Select the preferred workflow and press Back Choosing the Change Workflow icon will load the screen below enabling two workflow alternatives users can either Select Treatment mode first then Prepare System for use or Prepare System for use then Select Treatment mode Settings gt Change workflow 1 Select Treatment 1 Prepare System 2 Prepare System 2 Select Treatment Back 69 remaining procedures before maintenance Figure 37 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 Warning Never enter the Technician mode screen Only an IceCure technician or authorized representative is allowed to use the technician mode for maintenance or repair of the system 49 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 5 2
59. ering plug 4 Arrange a sterile work environment in accordance with accepted standards 5 2 2 Preparing the patient for procedure 1 Position patient comfortably so that the target area is easily accessible and trajectory of the probe is safe For example in the treatment of FA it is desirable that the probe will be placed parallel to the chest wall 44 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 Measure the lesion in all dimensions prior to procedure to determine long axis and point of entry 3 See Figure below for a schematic illustration of the placement of the system and the patient in the treatment room lceSense3 System assistant Surgeon Figure 29 Schematic illustration of placement of the system and patient 5 2 3 Switching on the IceSense3 cryoablation system Before operating the system make sure the following conditions are in place e Ultrasound or other appropriate imaging system is available for monitoring the medical procedure In case of open surgery or superficial cryotherapy no external imaging device is required e The mechanical power switch is OFF e 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 screen will turn on and the following screen will appear 45 IceCure Medic
60. essage will appear Please wait until the system is ready for test 7 When the system is ready place the probe inside a sterile Saline cup 8 PressTest by pressing the BLUE button on cryohandle OR by pressing on the console touch screen Notice that you don t see any bubbles that the shaft is not frozen and that a small ice ball is created at the tip of the probe 9 Ifthe test was successful press Success If not start over with a new sterile probe Procedure 10 Select treatment modality Preset Cycles Manual Mode You can modify the cycles as needed during procedure 11 Insert the probe to the breast and navigate with the help of Ultrasound to stub through the lesion center 12 Activate treatment cycle Press FREEZE on the console touch screen OR Press the BLUE button on cryohandle e Monitor ice ball under ultrasound at all times e Inject saline buffer as needed to protect the skin e You may manually stop the first freeze cycle and start the Thaw process by pressing Skip This is done by pressing the BLUE button on cryohandle OR by pressing on the console touch screen e You may manually stop the second freeze cycle and start the Warm process by pressing Warm This is done by pressing the BLUE button on cryohandle OR by pressing on the console touch screen 13 During the warm process gently remove the probe When the warm process is finished you can press finish if you have manage to remove the probe from the body or contin
61. fidential User Manual e If you answer Cancel you will stay in the thaw screen e If you press OK you will get the Lowering the dewar message figure 61 below Treatment preset O 7 00 05 00 07 00 E ense e Cure Current step Protocol Total Protocol Time 19 00 win 8 Freeze 07 00 01 27 Freeze 15 00 00 P 03 3219 i Lowering the Dewar Please wait Probe 13 DO NOT DISCONNECT Figure 61 Lowering the dewar e The system will perform several steps and at the end it will inform you that it is safe to replace the dewar and you will get the Replace dewar screen figure 62 below e Please enter the new dewar instead of the old one and press ok to continue e At the same time you will get an interactive update of the thawing time 70 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Treatment preset 07 00 05 00 07 00 ceSense3 Vy Locure Replace Dewar Replace the Dewar and press OK to continue Pd Thaw Time 03 47 0 T e Probe 13 DO NOT DISCONNECT Figure 62 The replace dewar screen and press ok to continue e 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 63 below Treatment preset 0 7 00 05 00 07 0 Cese se3 RR Replacement done Proceeding Please wait Thaw Time 04 18 Probe 13 DO NOT DISCONNECT Fi
62. for Treatment 1 Connect Probe Functional Test H 4 Cancel Figure 40 The dewar preparation screen 5 2 7 2 Cryoprobe Selection Select a cryoprobe according to your clinical judgment lt 1 4cm Cryoprobe S 3 00 min 1 00 min 1 00 min 1 00 min 1 5 2 0 Cryoprobe S 4 30 min 1 30 min 1 30 min 1 30 min cm 2a Cryoprobe 6 00 min 2 00 min 2 00 min 2 00 min cm S L 2 6 3 0 Cryoprobe L 8 00 min 3 00 min 2 00 min 3 00 min cm 3 1 4 0 Cryoprobe L 12 00 min 4 00 min 4 00 min 4 00 min cm Figure 41 Experiments in gel results 5 2 7 3 Cryoprobe registration Identify the cryoprobe serial number S N It appears on the cryoprobe package and on the cryoprobe plastic grip as shown in the figure below and on the screen 53 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Serial number LB Figure 42 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 Prepare for treatment 13 18123 l 8 o 4 1 Cancel Figure 43 Cryoprobe registration screen Caution Verify cryoprobe S N registration by double checking the serial number on the package and on the cryoprobe itself Entering an incorrect cryoprobe S N registration will result in probe nullification 5 2 7 4 Cryo
63. gure 63 The replacement done follow up screen e When preparation of the new dewar are complete the system will come back to the Thaw cycle figure 64 or to the next freeze cycle if the time to complete the replacement exceeded the preset Thaw time figure 65 71 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Treatment preset 07 00 04 00 07 00 07 53 07 0 Freeze Manual Figure 64 Replacement was completed before the Thaw ended Treatment preset 07 00 04 00 07 00 05 58 Freeze m _ Freeze n 06 43 E Skip Manual Figure 65 Replacement was completed after the Thaw ended 72 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 5 4 Post operational stages 5 4 1 Removing the temperature sensor from tissue At the end of the cryotherapy procedure the temperature sensor should be removed from the tissue by carefully pulling on it The extraction should be done only after a passive thaw of a few minutes since the temperature sensor can be surrounded by ice Removing it too quickly before thawing can damage the target tissue 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 5 4 2 Removing the cryoprobe from the cryohandle After removing the cryoprobe fro
64. has been bent dropped hit against a hard surface or compromised in any manner as internal damage to the cryoprobe may have occurred 5 2 7 5 Sterile sleeves After filling the dewar and placing it in its compartment please work sterilely Cover the touch screen and flexible hose with the suitable single use sleeves and the cryoprobe holder with a single use cover to ensure sterility 5 2 7 6 System test Perform a functional test to ensure system efficacy and safety per the following instructions and per the screens presented in the figures below e Prepare a container full of sterile saline e Insert the cryoprobe into the container and press the Action button on the handle or Test on the touch screen Preparefor Treatment Probe S N Connect Probe Test Cancel Probe 013 DO NOT DISCONNECT Figure 45 Functional test screen e The system will check essential parameters 56 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e A failure of any internal test will result in a message suggesting to perform another pre test Only if the second pre test also fails an error message will be displayed on screen Please record the error number and follow system instructions until you are requested to remove the probe safely from the cryohandle and contact IceCure Medical If you choose not to perform another pre test press Cancel and follow system instructions until you are required to safely r
65. ify us promptly in writing of any claims and shall provide us with the opportunity to inspect and test each item claimed to be defective Such inspection may be at our laboratory Replacement or repair shall be contingent upon our examination disclosing that defects have not been caused by misuse abuse improper application improper electrical supply as specified in the equipment s official user manual unauthorized transfer of ownership unauthorized repair alternation accident or negligence Geographic relocation of the equipment may at our reasonably exercised option result in exclusion of the equipment from warranty coverage This warranty shall not apply to electron tubes lamps fuses batteries and any other parts which carry separate warranties based upon usage The warranties contained herein are in lieu of all other warranties express or implied as to the condition merchantability fitness for a particular purpose or any other matter concerning the equipment or its use or performance Buyer hereby waives any claim it may have against seller for any loss damage or expense of any kind whatsoever caused by any defect therein the use or maintenance thereof or any servicing or adjustments thereto not expressly covered by the warranties contained herein Buyer further agrees that seller will not be liable for any incidental consequential or special damages for any lost profits or for any claim or demand against the buyer by any o
66. iquid nitrogen dewars should be performed by authorized personnel only e Check that the dewar is fully filled see the arrow in Fig 40 and cover it with the sponge lid to transfer it back to the system e Check there is no frost on the dewar after you filled it e Inthe event that a dewar is damaged use another dewar to continue the procedure Warning 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 e Take off the lid and place the dewar in its position into the system Warning Removing the dewar or placing it back within the system after refilling it must ONLY be done according to system instruction and with the carriage in the bottom position If the carriage is not in the bottom position liquid nitrogen may spill out e Close the compartment door and press the Action button on the cryohandle or Next on the screen 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 Close the door to continue 92 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual umm rmm Prepare
67. it might increase the risk of hematoma e Atthe end of the warm step a message will be displayed on screen informing the user that the warm cycle is done e Ifthe cryoprobe cannot easily be extracted from the tissue press the Active warm button on the cryohandle or Warm icon on screen to initiate another warm cycle e 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 After the cryoprobe has been removed from the tissue press the Action button on the cryohandle or the Finish icon on screen to complete the procedure e The system will then perform several steps and at the end it will inform you that it is safe to disengage the probe Surrent Step Elapsed 00 58 Finish Press Finish AFTER extracting the probe Figure 59 The Active warm screen during procedure e Instruct patients o To remove gauze dressing after 24 hours and to expect minimal discharge Adhesive skin closure should be removed after 7 days if it has not already fallen off o That they may need over the counter analgesics for mild discomfort after procedure o That swelling and moderate ecchymosis may be present for several weeks 68 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning In case of a total freeze time of less than 1 30 minutes the active Warm process won t be available
68. l cavity rectum and skin e The system may be used for ablation of breast fibroadenomas Thoracic Surgery e The system may be used for the ablation of arrhythmic cardiac tissue e The system may be used for the ablation of cancerous lesions Proctology e The system may be used for the ablation of benign or malignant growths of the anus and rectum e The system may be used for the ablation of hemorrhoids 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 e You are a board certified medical practitioner licensed in your country IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e You have taken a certified IceSense3 cryoablation system training course e You have read and understood all relevant material accompanying the IceSense3 cryoablation system 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 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 cli
69. lowed at all times Handle liquid nitrogen with care Contact with skin may cause serious frostbite Do not allow objects cooled by liquid nitrogen to touch your bare skin Objects cooled by liquid nitrogen may stick to the skin and tear flesh when attempting removal Protective clothing can reduce the hazards of handling liquid nitrogen Insulated or heavy leather gloves should always be worn when handling any object that has been in contact with liquid nitrogen Loose fitting gloves are recommended so that they may be discarded quickly in the event that any liquid nitrogen splashes into them If you are working with open containers of liquid nitrogen boots should be worn and trousers should not be tucked into boots but worn outside Personal protective equipment is essential and can save you from liquid nitrogen s risks Full face shield and safety glasses are recommended for eyes face protection Fill the container slowly to avoid the expansion stress that occurs as a result of the rapid cooling Too much stress can damage the container 19 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Do not seal the containers tightly The use of a tight fitting stopper or plug that prevents the adequate venting of gas allows a build up of pressure that could severely damage or even burst the container Even an accumulation of ice or frost on the lid can interfere with proper venting To assure safe operation only use the
70. m the target tissue and the message that it is safe to disengage the probe is displayed detach the cryoprobe from the cryohandle as follows 1 Carefully place the plastic cover on the tip of the cryoprobe 2 Unscrew the used cryoprobe from the cryohandle and dispose of it appropriately 3 Remove the single use sterile cover from the cryohandle 4 Close the cryohandle with the covering plug Elapsed Total Protocol Time 07 30 02 36 Safe to disengage the probe from the handle Main Menu Figure 66 Protocol Completed Screen 73 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Dispose of the cryoprobe and cryohandle sleeve in accordance with institutional policy Do not reuse do not resterilize 5 4 3 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 panel 5 4 4 Exiting the lceSense3 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 Safe to disengage the probe from the handle Main Menu Figure 67 Protocol Completed screen Pressing on the Main Menu icon green arrow will load the Main Menu screen 74 IceCure Medical Ltd DSR3100000 rev
71. matic mode eeeeeeeeseeeeeeeeeeeeeeeeese eee tenent 67 Figure 59 The Active warm screen during procedure ccccccccccecsssesseececeeeeeaaeesseeeeeees 68 FErieure 60 Protocol C ompleted Scree hiriren tee odi Uto ed s uide etu eno etd UE ides 73 Figure 61 Protocol Completed screen Pressing on the Main Menu icon green arrow will Toadthe Mam Menu SCL CCI ouis denote aad oe oueaui deed toda Duae anaes tue oet Debo DOO 74 Figure 62 The Main Menu screen To exit the system press on the Exit icon green 21809172 PEE 75 Figure ose System Pai exaimple SCF SIi sien ensis tet oMont ucc ee i ie ies 76 Figure 64 The Emergency Stop button located on the main chassis green arrow TI Figure 05 A sample TOUCH SCEGBPDL cas stsedeudsdssnedbecsacavenceandansunadeushdeenesbeutanatenreendanentsdondudueraces 78 Fisure 00 Status dressdbe example 25m deed ede teda ba toe c end to ararainnces 79 Figure 67 Warning message format example seessssssssseeeeeeeee enne 80 Fisure OS Error messase Tormat ex ample 2 552 8 5 DUMP T O 80 Figure 69 The cryoprobe components the figure is for illustration only 82 5 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Figure 70 counter of the remaining procedure before maintenance green arrow at the bottom or Meman Menu SCEEGTI ocaeca a E a 84 IceCure Medical Ltd DSR31000
72. measurements when inserted in tissue Use of temperature sensors is optional the decision to use a temperature sensor must be made before the system pretest is initiated 36 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Prior to starting a procedure the temperature sensor is connected to the system and inserted into the desired locations within the tissue Insert the sensor at locations that give useful information about the progress of the freezing procedure For example the temperature sensor can be placed near the boundary of a tumor to ensure that the entire tumor has been frozen Alternatively the temperature sensor may be placed near an organ that should not be frozen during the procedure to ensure that the ice front has not advanced to this location 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 system The temperature sensor and its components are depicted in the following figure e amp Figure 24 The temperature sensor and its components Temperature sensor needle Temperature sensor handle Temperature sensor cable connector p oe I9 13 Temperature sensor connection site If you decide to use a temperature sensor connect it per
73. mergency Stop button may damage the system After pressing the emergency stop button wait for passive thaw before extracting the cryoprobe from the tissue To release the Emergency Stop button turn it clockwise TI IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 6 COMPUTER INTERFACE 6 1 The technician menu 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 Warning Never enter the technician mode screen Only an IceCure technician or an authorized representative can access this mode for maintenance or repair of the system 6 2 Reading the screen The screen within the control panel is represented by the picture below Preparefor Treatment Dewar Probe S N Connect the probe and press Next f Next Cancel Ensure sterility according to medical standards Figure 71 A sample touch screen 6 2 1 Parts of the Screen The following key defines the numbered parts of the above figure 1 Logo bar 2 System mode 78 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 3 Wizard Instruction area 4 Main interaction area 5 Icons 6 Status display 6 3 System messages Messages can a
74. must be referred to IceCure Medical 9 2 Troubleshooting guide Problem Probable Cause Main chassis does not Rollers are locked move No system power AC power is not connected to the system power supply malfunction AC power is on butthe Computer power supply screen does not turn on malfunction or computer error Dewar compartment Door held shut by magnet door does not open The door is open but Carriage is not in correct the dewar is not visible position Action Unlock the rollers transport the system and lock the wheels again If the problem persists contact IceCure Medical service Check that the power cable is connected to the inlet and the wall outlet Check that main switch is ON If still there is no power contact IceCure Medical service Check if the computer power cable is connected to the screen and turn the screen on If the screen still does not turn on contact IceCure Medical service Try to open the door using reasonable force If door will not open contact IceCure Medical service Turn the system off and try to restart the system If the dewar is still in its upper position contact IceCure Medical service 85 IceCure Medical Ltd Confidential Problem Dewar is jammed and cannot be removed System provides Wrong cryoprobe S N message Connect the probe message displayed constantly on the screen Freeze Warm icon does not initiate the operation L
75. n system includes e Main chassis e Adjustable touch screen e External accessories foot pedal Not available in some regions e g China temperature sensor connected to the main chassis and single use cryoprobe connected to a cryohandle 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 Located on the top of the chassis are a touch screen control panel and a cryohandle holder On the right upper part of the chassis is the Emergency Stop button a round red button that shuts down the system immediately in an emergency situation On the back of the chassis are two hooks used for hanging the electric cable and a grip handle for ease of system transportation Figure 18 The IceSense3 transportation rollers amp brakes 3 3 2 Emergency Stop button The Emergency Stop button is a red knob located on the right upper side of the chassis It is designed for emergency shutdown of the unit Pressing this button immediately turns off the electrical power supply to the system To release the Emergency Stop button turn it in the direction of the arrows 33 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Figure 19 The Emergency Stop button Warning AN Only push the Emergency Stop button when there is NO other choice Wherever possible use
76. ng the mechanical ON OFF button on the main chassis and then remove the plug from the power supply 5 5 2 IceSense3 cryoablation system touch screen failure If the touch screen shuts down you will need to shut off the system with the mechanical ON OFF button and remove the plug from the power supply This will end the cryotherapy procedure 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 However in case of emergency you may press the RED ROUND Emergency Stop button located on the right side of the main chassis The Emergency Stop button is designed for emergency shutdown of the unit Pressing this button immediately turns off the system Switch OFF the mechanical ON OFF button and unplug the electrical cable 76 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Figure 70 The Emergency Stop button located on the main chassis green arrow Warning If a liquid nitrogen leak is detected at any time PUSH the Emergency Stop button immediately Warning Push the Emergency Stop button ONLY when there is NO other choice Wherever possible the system should be shut down by the standard procedure Excessive use of the E
77. nical use of the IceSense3 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 IceSense3 cryoablation system in special populations such as pregnant women has not been established For further details refer to Section 1 3 Indications for use 1 6 Qualified technician Only a technician trained by IceCure Medical is qualified to service the IceSense3 cryoablation system Servicing includes periodic service and repair of the system Warning Do not modify this equipment without authorization of the manufacturer IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 SAFETY NOTES While this manual is designed to provide instruction 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 This chapter defines the different types of safety notices that appear in the manual 2 1 Warnings and cautions Safety notices appear throughout the manual and take one of the following forms Warning this notice is called a Warning it deals with danger to people Warning It is dangerous for people to do this Caution this notice is called a Caution it
78. obe from the cryohandle if you are not clearly required to unscrew or disengage it Caution Verify cryoprobe S N registration by double checking the serial number on the package and on the cryoprobe itself Entering an incorrect cryoprobe S N registration will result in probe nullification Warning Do not allow any liquid to enter the cryohandle Always keep the cover on the cryohandle Warning In case of a total freeze time of less than 1 30 minutes the active Warm process won t be available Wait for passive Thaw 17 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning In case of frost on shaft if possible start active Warm If not wait for passive Thaw In both cases use skin protection techniques 2 4 Liquid nitrogen Nitrogen gas is a potential asphyxiant In the event of a large liquid nitrogen spill personnel should adhere to a predetermined evacuation plan Seek medical help immediately if breathing problems occur Warning If a liquid nitrogen leak is detected at any time PUSH the Emergency Stop button immediately 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 An easily accessible fire
79. ormat and changes you have made if any to the preprogrammed protocol Safe Operation in Percutaneous Procedures When performing percutaneous cryotherapy procedures meticulous observation of the incision site and the skin overlying the treatment site is required Skin protection techniques must be implemented to avoid thermal injury to the skin Skin protection techniques include but are not limited to dripping room temperature sterile saline on these areas continuous monitoring of the growing ice ball by ultrasound utilizing an external thermocouple to measure skin temperature injecting sterile normal saline or local anesthetic between the skin and the ice ball formation and placing moist gauze between the skin and the cryoprobe 5 3 3 Active warm process The active warm step occurs at the end of every treatment Its purpose is to allow you to remove the cryoprobe from the target tissue in the fastest and safest way e To activate the Active warm press on the Active warm button on the cryohandle or the Warm icon on one of the freeze mode screens as previously shown 67 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e The Warm screen will be displayed and a time count will appear e Wait until you can gently remove the cryoprobe for example 40 50 seconds for 2cm iceball from the target tissue extract the probe and then press Finish Do not force removal of the cryoprobe from the tissue as
80. placement of the system and patient 45 Figure 30 The system 1s loading Scelus dit ete eo eL eiae ee d Reste ee praemia sidus 46 Figure 31 The Main Ment sSereell usoee nies iet adven et Extent ati dd urat auia uctus etum dete 46 Figure 32 The Action button as displayed on screen several of the options 47 Figure 33 The active Warm button as displayed on screen eee cccccececeeeeeeeeeeeeeeeeeeees 47 Pierre 54 Lat ere ative inl SCC oscil este a esac decane ete leans aoa ace aoo tuu eee cero eat 47 Figure 35 Activating the Settings option from the Main Menu screen sssss 48 Lisuie 20 Ihe Set IP S SCEE s use ttac user tet co ipai otewa sedi Eos e tiroertp ud eo intenta tasniulib Ede tenenda dion 48 Figure 37 The Change Workflow screen with two alternative workflow settings 49 Figure 38 The Windows Date and Time Properties screen eeeeeseessssse 50 Figure 39 Preparing the system for treatment by pressing Prepare for Treatment green arrow on Maii MENUS sCcteeli c etre tiM M MEI M SR E E RD A IUE 51 Fisure 40 The dewar preparation SCreeny s 0cteriemsateseatientieni sade sedation odd pr sd EE Sauce tu Panda 53 Pisure4 iE x perminentsn 9el tesullSss ie toU eoi POUR Re uate id Rd oa aac idee tn ae euche eects 53 Figure 42 The cryoprobe the figure is for illustration only eeeeeeeeeeee 54 LIioure 45 Cryoprob
81. ppear 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 External temperature sensor readout will be displayed in the right bottom corner Other status messages such as the type of cryoprobe currently connected will be displayed in the left bottom corner For Example Prepare for treatment Dewar door is open Close the door to continue Probe 13 DO NOT DISCONNECT Figure 72 Status message example 6 3 2 Warning messages Critical information will appear as a pop up dialog with an OK button for acknowledging the message If a warning message appears during a treatment it will appear in the following format 79 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual A O pe ned Dolo r Headline Dewar door is open Close the door to continue User Instructions Figure 73 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 When such a message appears the user should carefully follow system instructions If an error appears during a treatment it will appear in the following format A M ISSI ng DIANE r Headline The dewar is not in place User Load a full dewar and press OK
82. probe connection Connect the cryoprobe to the cryohandle as follows while maintaining sterility of the probe 54 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual e Remove the plug that covers the probe connection point e Insert the cryoprobe into the insertion point in the handle as shown on screen and screw it until written message light appears on screen to confirm that probe is in place e When done press the Action button on the handle or Next on the touch screen Prepare for Treatment Var Bey CONNEC TORE Aa Connect the probe and press Next Next Cancel Ensure sterility according to medical standards Figure 44 Cryoprobe connection screen Warning Never reuse a single use cryoprobe or a single use sterile sleeve Warning Never unscrew the cryoprobe if you are not clearly required to unscrew or disengage it e After pressing Next a Do not disconnect message will appear Warning After completion of all treatments of a given patient make sure that the single use cryoprobe and single use sterile sleeve are removed and discarded 55 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Before beginning treatment of a new patient you MUST ensure that the previous single use cryoprobe and sterile sleeve have been removed Warning Cryoprobes are fragile and can be damage if mishandled Do not use a cryoprobe that
83. rvice Check user manual to verity that the LED should light up If yes contact IceCure Medical service This is not an operational problem Wipe off accumulated ice with clean sterile gauze Push the Emergency Stop button and contact IceCure Medical service Check that the temperature sensor is well connected If so change the temperature sensor If temperature reading is still unreasonable continue the 86 IceCure Medical Ltd Confidential Problem Cryoprobe tip cannot easily be removed from target tissue Cryoprobe is difficult to detach from cryohandle Nitrogen leak when trying to remove the cryoprobe Computer failure due to hardware fault Screen is stuck Controller stops working Controller is stuck DSR3100000 rev K Probable Cause Warm process malfunction Parts are frozen together Excess pressure on the pipes main valve open procedure not completed or dewar relief valve malfunction Unknown Unknown Table 1 Troubleshooting guide IceSense3 User Manual Action procedure without a temperature sensor If problem persists contact IceCure Medical service Do not use force in attempting to remove the cryoprobe from the tissue Wait 7 minutes and try removing it again If problem persists contact IceCure Medical service Try again after five minutes If it still cannot be detached contact IceCure Medical service When initial leak is detected
84. s idum outicaidu Grat ctuss odes ca eU sue a ete UE 38 Oe Operan ond dle balls aee tautum eade itia tia utei UAE E tut Moi cd 39 SHE EAM OMe SPEI ooo oan Odin apettade eadein estare ipd E 39 em MEME CCS RE T E NUN 40 SAO CrvoablatiOn procedure do aee ici er edi o tan ioo Feo tedal CE DIN ita io Dor do edat 4 DA MWS C uiis owns oi ddeoaeaeutscdo e a a 4 A INSTALLATION AND SETUP 5 2 6i ubere eade T ire ae ie duos 42 4 Space and positioning requiremieDfs seii reru eter o daD Ee ehe quor Mab eere toner bo Bab reve eda 42 4 2 Setup warnings and cautions uie enean oer Pret uud ot AP edlen ovre du get og pa tede 42 A JBElecteical Tegutterie ts uev doe sce sedute a ro bees dut vd tin URDU EOM UR SECULI e cE AE 43 T Smpment compoHe fs ueteri push SEuttata N 43 doc PITS CARNAL ON eaten pat etate dni uM Re Edo Rub M ELLE Reti 43 a OPERATING THE S TAS TEN si dde od eese ud vd conia buie ERU Le dace aded 44 o Procedure OVeLVIe W arcem enne duse veniunt mo oeste e o E pP adds 44 2 2 Pre operadonal Sti o oiscsaisb n RE a e Ha EAE tute te Mod aRe bI LA DIE 44 5 2 1 Preparing the system for procedure eseeessssssseeseeeeeeenne eene 44 5 2 2 Preparing the patient for procedure eeeeessssssseeeeeeenneeeeeeeennns 44 5 2 3 Switching on the IceSense3 cryoablation system eeeeeesssss 45 Iek COn deest dudes m tero tinam mao et mE DM clu Mea pe MEE 46 SEMEN USB MIRI INU selec Secs m 47 5 2
85. software Failure to do so will increase the risk of a liquid nitrogen related accident 22 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 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 Warning When the system shuts itself down due to an error contact IceCure Medical and describe the error message shown on the screen as precisely as possible Do not attempt to reuse the system before contacting IceCure Medical After reporting or making note of the error message switch OFF the mechanical ON OFF button and unplug the electrical cable 2 6 Adverse events Warning Regulatory requirements mandate that serious adverse events be reported to the relevant regulatory authorities Users must notify IceCure Medical of all serious adverse events including serious adverse device reactions no later than 24 hours following receipt of such information 2 7 Compliance 2 7 1 Compliance with international safety standards The IceSense3 cryoablation system was designed and built in accordance with ASTM international standards Designation F882 84 Standard Performance and Safety Specification for Cryosurgical Medical Instruments re approved in 1996 e EN 60601 1 Standard for safety of Medical equipment e European MDD 93 42 EEC e EN 60601 1 2 Standards for
86. t in the clinic room Caution The IceSense3 cryoablation system must be unpacked installed and tested by an IceCure Medical authorized technician only and in accordance with the unpacking instructions manual Caution There are no user serviceable parts in the system Refer all service issues to IceCure Medical s Customer Service Department Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure 13 gt gt b b b IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 2 2 7 Proper use Caution Do not use the workstation or the liquid nitrogen dewar for any purpose other than operating the IceSense3 cryoablation system Caution The liquid nitrogen dewar supplied with the IlceSense3 cryoablation system is a dedicated system part and should not be used for any other purpose Caution Dewars should always be stored with their lids in place Caution Only dewars and lids supplied by IceCure Medical may be used with the IceSense3 cryoablation system Warning 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 14 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning
87. 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 Figure 21 The flexible hose cryohandle and connected cryoprobe Flexible hose Cryohandle Cryoprobe insertion point ee ce Ss ie ox Cryoprobe Action button allows the user to select actions that appears on the screen Warm button activates deactivates the warm function LED indicator displaying BLUE to indicate the freeze mode is ON 35 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual Warning Never reuse a single use cryoprobe temperature sensor or sterile sleeve Warning At the conclusion of each patient session remove and discard the single use cryoprobe temperature sensor and sterile sleeve 3 3 6 Handle plug holder The handle plug holder is located on the top of the main chassis and allows a place for keeping the plug while performing the procedure Make sure you close the plug after each procedure Figure 22 Handle plug holder 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 Figure 23 The foot pedal 3 3 8 Temperature sensor TS The temperature sensor is a single use accessory that provides real time temperature
88. the following instructions while maintaining sterility 1 Remove the temperature sensor from the sterile package 2 Connect the cable connector to the panel connector on the upper right corner of the main chassis while keeping the connector key facing the groove 3 The measured temperature from the sensor tip will appear on the right lower corner of the screen 37 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 4 Under imaging guidance insert the tip of the temperature sensor into the tissue you want to measure 5 At the end of the procedure gently remove the temperature sensor from the tissue and discard it Treatment using pti Current step Protocol Elapsed Total Protocol Time 05 15 01 36 00 21 Freeze 15 00 00 00 38 Skip Warm Manual Probe 013 DO NOI DISCONNECT Temp 18 7 Figure 25 Temperature display of sensor in the procedure screen green arrow AN 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 They provide storage for the Dewars When placing the Dewars inside the storage cases make sure they are well in stored see figure 24 Figure 26 Dewar storage cases the correct way to put the Dewars inside the storage cases 38 IceCure Medical Ltd DSR3100000 rev
89. ther party Seller s liability for damages under this warranty shall in no event exceed the purchase price Seller shall not be required to perform seller s obligations under this agreement or be liable for seller s failure to perform if non performance is caused by an Act of God war civil disturbance strike work stoppage transportation contingencies power failures laws regulations ordinances acts or orders of any governmental agency of official thereof or any cause not within the control of the seller Warranty Number Date of supply of equipment Date of expiration of this warranty certificate Buyer of the equipment IceCure Medical representative 92 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 14 CUSTOMER COMPLAINT FORM Section 1 Customer complaint To be filled by customer complaint recipient Complaint reported by Phone FAX Email Letter Sales representatives B Website B Other Name Title Position Address Phone Fax Product Name Batch No Serial No Description of complaint Initial consequences E Service No Harm L Injury E Death If death or injury occurred please describe below Complaint recorded by Name Title Position On Date Time Signature ATTENTION IF DEATH OR INJURY OCCURRED NOTIFY IMMEDIATELY TO ALL RELEVANT PERSONNEL ACCORDING TO PROCEDURES 93 IceCure Medical Ltd DSR3100000 rev K Confidential 1
90. uch screen the cover is used for the cryohandle holder 83 IceCure Medical Ltd DSR3100000 rev K IceSense3 Confidential User Manual 8 3 Periodic servicing Warning The IceSense3 cryoablation system is not user serviceable If there is any malfunctioning of the lceSense3 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 Periodic servicing will ONLY be performed by IceCure Medical authorized service representatives in compliance to the company service procedures and according to the procedure counter that can be seen in the bottom of the main menu screen see figure below Select Treatment Manage Protocols Show Last Treatment TI Figure 76 counter of the remaining procedure before maintenance green arrow at the bottom of the main menu screen Caution The system will not allow additional treatment when zero procedures left to maintenance Make sure to call IceCure Medical service representatives in time 84 IceCure Medical Ltd DSR3100000 rev K Confidential 9 TROUBLESHOOTING 9 1 General AN Warning IceSense3 User Manual 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
91. ue the warm process by pressing Warm and try again to gently remove the probe e f you press Warm more than two times the following message may appear Unable to warm Please wait for passive Thaw In this case wait for passive thaw and gently extract the probe from the tissue 14 Do not disengage the probe from the handle until the following message appears Safe to disengage the probe from the handle 15 After disengaging the probe immediately replace the handle s cap Warning messages Critical information will appear as a pop up dialog with an OK button for acknowledging the message 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 When such a message appears the user should carefully follow system instructions IceCure Medical Ltd Confidential DSR3100000 rev K 11 SYSTEM SPECIFICATIONS Physical properties Electrical requirements Operating pressure Cryogen Type of cryometer Environmental conditions Temperature range of cryoprobe Pressure sensor Dimensions excluding the screen Weight Pressure range Liquid Nitrogen Temperatures Operating Transportation and Storage Relative Humidity Operating Transportation and Storage Atmospheric pressure Operating Transportation and Storage IceSense3 User Manual Height 120 cm 4

User Manual DSR3100000 rev. K

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