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User Manual DSR3100000 rev. M

1. A sample touch screen display is represented by the figure below For further information about computer interface and operating the system see Chapter 6 Main Menu User Manual may also be access from the Main menu by pressing on the IceCure logo Select Treatment Manage Protocols Show Last Treatment Settings 90 remaining procedures before maintenance Figure 21 The touch screen display before a cryoablation procedure From the screen the User Manual is not accessible during the procedure if you try to open it during the procedure it will open only after the procedure s end 9 remaining procedures before maintenance Figure 22 The User Manual screen 37 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual You can choose the part you want to read from the Table of Contents click on it and you will access it directly eSense3 A e la hd Ed p LAI TH HAGA SG e w e mc IL kirle pirja Li a Tabili nl Cosas 1 CFV ERGY LI Introdzchon denke uus 13 Exhcaiees or ue L4 ua uw E Amaral drome G id Qualfed eha b SAFETY SOES Y amis dal canens Hi Bau Gey Pp in aal Chencndup it ui BD 1 Tratos ii 224 AL En 11 11 Cypri agar E arie 24 Lidl ro 241 Dinger cxp cexzn aed Bor hard 247 Gang Hr exar compartment 1435 Moda ngu prag panas 2 44 laud ruzrogen afer 245 Tee ka
2. AN Caution Do not move the system when the Dewar contains liquid nitrogen 4 3 Electrical requirements The IceSense3 cryoablation system is pre wired for the local line voltage as specified by the user Accordingly the unit will require a line supply of 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 e Main system e User manual e Twoempty Dewars e Accessories foot pedal Not available in some regions e g China single use probe kit single use temperature sensors Sterile sleeves sterile cover for the cryohandle holder liquid nitrogen and disinfecting wipes not supplied with the system 4 5 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 47 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 5 OPERATING THE SYSTEM
3. 40 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 3 3 8 Temperature sensor TS The temperature sensor is a single use accessory that provides real time temperature 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 Prior to starting a procedure the temperature sensor is connected to the system and inserted into the desired location within the tissue Insert the sensor at location that gives 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 Q e by S Y amp Figure 29 The temperature sensor and its components Temperature sensor needle Temperature sensor handle Temper
4. 7 4 1 2 0 Cancel 60 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Figure 48 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 Cryoprobe connection Connect the cryoprobe to the cryohandle as follows while maintaining sterility of the probe 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 a Next button appears on screen then confirm screwing by an additional slight rotation to confirm that probe connection is secured e Remove the probe cover that protects the tip e When done press the Action button on the handle or Next on the touch screen Prepare for Treatment Dewar Probe S N Connect the probe and press Next A Next Cancel Ensure sterility according to medical standards Figure 49 Cryoprobe connection screen 6l IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning Never reuse a single use cryoprobe or a single use sterile sleeve Warning Never unscrew the cryoprobe if you are not clearly allowed to unscrew or disengage it e After pressing Next a Do not disconnect message will appear Warning Aft
5. Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C DELEAGDLE TI BEFORE W WITCH OFF POWER SUPPLY DISCONNECT ALL PLUGS Wim MLS LILI mew pP Figure 6 Label 6 High voltage caution MLS1000006 Rev B Figure 7 Label 7 Line voltage danger MLS1000007 Rev B 9 1 M LZ 100a Rev E Figure 8 Label 8 Foot pedal MLS1000008 Rev B Figure 9 Label 9 Risk of Explosion MLS1000009 Rev B IceSense3 User Manual Za IceCure Medical Ltd DSR3100000 rev M Confidential IceSense3 Contigential 1 er Manual IceSense3 cure Cryoprobe REF FAP7700000 Rev X Use only with ceSense3 cryogenic devics SN 13 XXXXX o YYYYMMDD DD MM YYYY os DD MM YYYY ADAD C Ere Ice Cure Medical LTD Size 1 Haeshe 7 2nd floor Caesarea 38900 Israel Quantity ud Td 972 4 623 0333 ny J Fax 972 4 623 0222 www icecure medical com E Caution Federal law restricts this device to sale by or on the order of a physician B MLP7000001 Rev G Cryoprobs Size 12 SN h3 XXXXX r YYYYMMDD Figure 10 Label10 Single use probe MLP7000001 Rev F IceSense3gj IceCure Temperature Sensor FAT8000000 Rev X Use only with IceSense3 cryogenic devica YYYYMMDD DD MM YYYY i DD MN YYYY D QAD Ice Cure Medical LTD LE Haeshel 7 2nd Floor Quantity 1 Caesarea 38900 Israel Tel 972 4 623 0333 Fax 972 4 623 0222 www ice
6. User Manual DSR3100000 rev M 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 498 Halle Park Dr Ste 102 HaEshel 7 2 floor Collierville TN 38017 Southern Industrial Park icecuresupport icecure medical com Caesarea 38900 Israel Toll free 888 516 7389 info icecure medical com Tel 901 316 5672 Tel 972 4 623 0333 Fax 901 316 5944 Fax 972 4 623 0222 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 d IceSense are trademarks of IceCure Medical Ltd in the United States and other countries IceCure Medical Ltd and other rain t IceSense3 IceCure and lc Contents have trademark rights in other terms used hereir l 2 eid 7 LIO CHO oia T 1 2 Inte ndec Se esses o NOME OIM MS 7 1 3 Jndications TOR USE ate 7 IP MEMOIRE 8 A o OO PIS 9 1
7. ma mm mm mm mm mm mm mm FAP 7800000 mum A 2mm a 19 30 16 27 18 3min 36 24 32 20 29 16 4min 38 28 34 23 30 17 Smin 41 30 35 24 30 18 6min 43 32 36 26 31 19 8min 46 35 38 28 32 21 10min 47 38 39 30 33 22 I5mn 51 46 39 34 31 24 58 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 3 4 SHORT 3 4 Short FAP7300000 Sms 4 3 9 5 26 i 3 30 27 22 IS min 48 44 36 33 28 24 3 4 LONG C 2c C _ aig o Pemr mm mm mm mm mm mm FAP7200000 3 4 Long FAP 7400000 FAP 7410000 59 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Figure 46 Iceball isotherms of IceSense3 cryoprobe from experiments in gel at room temperature 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 Serial number A Figure 47 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 8 5
8. 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 Figure 20 The Emergency Stop button Caution A Only push the Emergency Stop button when there is NO other choice Whenever 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 major electrical risk 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 Caution Do not pull the system by the cryohandle or flexible hose The flexible hose shouldn t be bent or flexed during procedure 3 3 4 Touch screen and User Manual activation 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 36 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Do not connect any signal input output port to the touch panel PC except medical certified equipment provided by IceCure Medical
9. Figure 55 Steps for adding a protocol esses nena hann n narra noa 67 Figure 50 Edit Preset SCEOEIL sra nn 67 Figure 57 Choosing the Manual Mode option green arrow ooooonnnncnccncnnnnnnnnnnnnnnnnnnonannoos 68 Figure 58 illustration of a short 3 4mm probe 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 maria circos 70 Figure 59 Pause and Play buttons during the freeze cycle seeessessssssse 71 Figure 60 Manual Mode screen press on Freeze to start the freeze cycle 72 Figure 61 Freeze screen in Manual Mode ud 72 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Figure 62 Ihaw screen in Manual Mode rincon dada 73 Figure 63 Warm screen in Manual Mode essen 73 Figure 04 Freeze SCreem dn Automate Mode 75 Figure 65 The Active warm screen during procedure cccsesesseessssessesssssessesseseesesseees 76 Figure 66 Replace Dewar option QUEStION ooccccccccnnnnnnnnnnonononnnnnnonnnonnnnnnnnnnnnnnnnnnnnnnnnnanannos TI Figure o7 L owerme the Deals elut dte da 78 Figure 68 The replace Dewar screen and press ok to continue 00ooooccocococooooonnnnnnnnnnnnnnnnnnnnos 79 Figure 69 The replacement done follow up SCTEN ooooooocccococooooonononnnononononononnnnononononnnnnnnos 79 Figure 70 Replacement was completed
10. Insertion part Plastic grip Serial number Shaft Probe tip Cool Zone center Figure 83 The cryoprobe components the figure is for illustration only There are various cryoprobe configurations For example Cool zone Length i Probe name shaft tip Diameter la fi Tip distance from 3 mm the tip FAP7100000 Trocar Spheric 127 mm 3 4 mm 3 4 Short FAP7200000 Trocar Elliptic 140 mm 3 4 mm 3 4 Long FAP7600000 Trocar Spheric 10 mm 125 mm 2 4 mm 2 4 Short 9 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual FAP7800000 Trocar Elliptic 14mm 133 mm 2 4mm 2 4 Long The IceSense3 cryoprobes are available in various diameters 2mm to 3 4mm various iceball shapes Spheric Ellipsoid various tips trocar blunt and pencil and various lengths 126mm to 421mm external shaft length according to the expected application treated tumor size and surgery approach Certain configurations are not available in some regions Insert the cryoprobe based on iceball size you want to obtain and the cooling zone location as defined in the table above Always monitor the ice ball engulfment with appropriate imaging modality 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
11. Preset icons or edit an existing protocol by pressing one of the pre defined Preset icons Preset Setup e ense3 vom ire Select a preset to edit Freeze Freeze Freeze 03 00 Preset y 02 Preset 03 Preset Ne Preset Preset Preset Preset Preset Back Probe 013 DO NOT DISCONNECT Figure 54 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 66 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 Edit protoco Freeze Steps Freeze 03 30 Freeze Save Delete Cancel Set the number of freeze steps and the step duration Figure 55 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 o ivi dl a II A Freeze 02 00 00 Freeze 02 00 00 00 Freeze 00 00 Save Cancel Delete select the number of freeze cycles and set the times Figure 56 Edit Pr
12. This chapter explains how to use the IceSense3 cryoablation system and includes pre operational operational and post operational steps Note This User Manual describes how to operate the device with a percutaneous cryoprobe that requires imaging device 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 imaging device 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 Close the cryohandle with the covering plug 4 Arrange a sterile w
13. 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 M 11 SYSTEM SPECIFICATIONS Physical properties Electrical requirements Operating pressure Cryogen Type of cryometer Environmental conditions Temperature range of cryoprobe Temperature range of Temperature sensor 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 47 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 196 C to 260 C Power supply 24 V Pressure range 0 1 145 psi Accuracy 1 Repeatability lt 0 1 99 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 12 LIMITED WARRANTY CERTIFICATE Terms and conditions for warranty of purchase
14. 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 other 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 100 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 13 CUSTOMER COMPLAINT FORM Section 1 Cus
15. before the Thaw ended 80 Figure 71 Replacement was completed after the Thaw ended 80 Figure 72 Replacement during Freeze in case of empty Dewar eeeesssssee 81 Figure 73 procedure stopped due to Low Nitrogen sees 81 Figure 74 Protocol Completed Oro iii iini tuse Nhan et tedio ojete sellers 82 Figure 75 Protocol Completed screen Pressing on the Main Menu icon green arrow wall doad the Mata Menu Sr it AAA 83 Figure 76 The Main Menu screen To exit the system press on the Exit icon green NN CE PEN 84 Figure 77 System Fail example screen eese cnn no cnn non nono nono nn 85 Figure 78 The Emergency Stop button located on the main chassis green arrow 86 Fieure 79 A sample TOUCH Orilla 87 Figure S0 Status Message examples sse evt da 88 Fisutess I Warning Message formal e xample 43 pt ot elect ti 89 Figure 82 Error message format example oooooooocococononooooononononononnnnnnonononononononnononononnnonononnnos 89 Figure 83 The cryoprobe components the figure is for illustration only 91 Figure 84 Counter of the remaining procedure before maintenance green arrow at the bottom of the main menu screen sse eene eene aran or eene eene eene eene 94 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 1 OV
16. designed to provide instructions in the use of the IceSense3 cryoablation system it is not intended to take the place of the user training course which must be completed before using the system 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 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 11 A A A A A A IceCure Medical Ltd DSR3100000 rev M 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 ref
17. 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 95 IceCure Medical Ltd Confidential Problem The door is open but the Dewar is not visible 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 LED does not light up Ice formation on the flexible hose the cryohandle and sterile sleeve Nitrogen leaks from cryoprobe cryohandle or system during the cryotherapy procedure Unreasonable temperature readings of temperature sensor DSR3100000 rev M Probable Cause Carriage is not in correct position 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 and long freezing cycles may causes moisture to form ice particles Cryoprobe is not well connected or pipes are faulty Temperature sensor or system malfunctions IceSense3 User Manual Action 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 Medi
18. 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 cryoprobe 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 or humidity to enter the cryohandle Always keep the cover on the cryohandle Warning In case of the active Warm process isn t available Wait for passive Thaw 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 18 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 Warm button immediatel
19. 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 below 69 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Figure 58 illustration of a short 3 4mm probe 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 Once you have verified the probe is located in its right place you may begin freezing 5 3 3 Freeze Cycle Selecting the type of treatment Manual or Automatic is discussed in section 5 1 7 Warning Portions of the cryoprobe other than the freeze zone including the plastic cover that is located near the cryoprobe handle may become cold and cause tissue damage If unwanted freezing occurs immediately stop the freezing process 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 5 3 4 Pause Option Pause option is available at any freeze cycle in Manual or in Automatic mode The use of the button is according to clinical judgment for re posi
20. of open surgery or superficial cryotherapy no external imaging device is required 49 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 Loading lceSense3 System Estimated time to complete 00 38 IceCure Figure 35 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 as explained in 5 2 6 4 Main Menu Prepare For Treatment Edit Presets Show Last Treatment Settings 50 remaining procedures before maintenance Figure 36 The Main Menu screen 50 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 5 2 4 Cryohandle The cryohandle allows the user to easily and safely handle the cryoprobe It also allows for several operational functions The cryohandle parts are detailed in Chapter 3 System description 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 37
21. 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 76 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 7 Replace the Dewar during a cryoprocedure Option to refill the Dewar is available at each Thaw cycle In case you intend to do a long treatment that will freeze over 12 minutes replace the Dewar during the thaw time of the procedure First be always ready with an additional full Dewar in case you consider you may need an additional Dewar for a longer freeze time e Atevery Thaw The system will automatically ask if you want to replace the Dewar figure below Maeaument opeset O D00 O5 0U bD54L0 Current step Protocol Elapsed Total Protocol Time 19 00 07 03 m Freeze 07 00 00 03 Fr
22. 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 from 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 Unscrew the used cryoprobe from the cryohandle and dispose of it appropriately 2 Remove the single use sterile cover from the cryohandle 3 Close the cryohandle with the covering plug Elapsed Total Protocol 1 02 36 o Safe to disengage the probe from the handle Figure 74 Protocol Completed Screen 82 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning Dispose of the cryoprobe temperature sensor 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 front panel 5 4 4 Exiting the lceSense3 cryoablation system treatment mode At th
23. 00 rev M IceSense3 Confidential User Manual A O pe ned Dolo r Headline Dewar door is open Close the door to continue User Instructions Figure 81 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 DINA r Headline The dewar is not in place User Load a full dewar and press OK Instructions If the problem persists contact technical support Figure 82 Error message format example Pressing the OK button will indicate you have read this message and will dismiss this popup 89 IceCure Medical Ltd DSR3100000 rev M 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 90 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 7 ACCESSORIES 7 1 Cryoprobe 7 1 1 Single use sterile cryoprobe Distal
24. 6 Qualified technician oocccnnnnnocccnnnnnnnnnnnnnnnonnnoconnnnnonononnnnnnnnnnrnnnnnnnnnronnnnnnnanocrnnnnnnanioos 9 ey 3 0 9l SOSA on MINIME 10 DALE LY NOLTE Saab 11 21 Wy AURIS CAU OG as 11 2 2 a A ne N ULIS HoRESPDIDEAGR INE NUI RU E EUG 11 2 24 e o 11 Laa QUAIL torpe 11 22 3 A a 12 pU A A 12 2 2 E eS Us dpt quU MIN 13 2 200 Installation and SeDUD ici 14 PAPA A A A E A i 15 2 9 OPE AMO E E E 16 E O 19 2 4 1 Danger explosion and fire hazard ieia einni 19 242 Opening the Dewar comparent usen cto ere tet born te un geo rud iio 19 243 Voltageand power Tallas rmac a 20 244 ii o AA 20 AA 21 246 Grounding ETNRRRR 22 A II E E S AE E E IAE 22 2 4 8 Mechanical handling of flexible hose and cryohandle 22 29 3BNUICIGCHOICS Ono cio 22 Zoos Homer benc SLOP DUC IN AAA et eet A e c es e auf 22 2 5 2 Emergencies causing procedure halt oooooccnnnccoconocacacanananonanonooooro nono nnononnnnnnoos 23 OR MM VES En EUM NNI MINIME NUMEN M 24 A S ILU NENNT 24 2 7 1 Compliance with international safety standards seeeeeseee 24 29 Buuteimenpeldss tHICO Mino 24 2 PCCM AMAL ladera 24 294 Important Symbols and Labels siria iras 31 S LEN DESCRIPTION smc setas E Ruse coast 34 A e on II 34 J32 OMG CDF OL OCA ON NEUES 34 A ee non eee A rE 34 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidenti
25. CUSTOMER COMPLAINT Send to IceCure Medical Inc 498 Halle Park Dr Ste 102 Collierville TN 38017 icecuresupport icecure medical com Toll free 888 516 7389 Tel 901 316 5672 Fax 901 316 5944 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 Borkstralse 10 48163 M nster 153 Germany Tel 49 0 251 32266 0 Fax 49 0 251 32266 22 102 IceCure Medical Ltd DSR3100000 rev M 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 EN 61000 3 3
26. Complies 103 IceCure Medical Ltd DSR3100000 rev M 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 3 V Recommended separation distance 61000 4 6 150 kHz to 80 d p3WP Vi MHz 3 5 d P 80 MHz to 800 MHz Ei Radiated RF EN 3 V m 3 V m 61000 4 3 80 MHz to 2 5 d GHz LP 800 MHz to 2 5 GHz Ei 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
27. ERVIEW 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 IceSense3 cryoablation system is indicated for use as a cryosurgical tool in the fields of general surgery including breast tissue dermatology thoracic surgery including lung tissue 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 cryoablation system may be used with
28. GER 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 Black Dewar Label 14 COLD area Label 15 Empty LN2 Dewars Label 16 Applied parts Label 17 Shipping Art Work There are additional labels inside the system that are not visible to the user These labels are intended for the technician 25 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual System Labels ON OFF MLZiODOOO Rev E Figure 1 Label 1 On Off mechanical button MLS1000002 Rev B Figure 2 Label 2 Emergency Stop MLS1000003 Rev B IceSense3 g IceCure SN IS XXXXX mi DD MM YYYY es AAS3100000 rev Ice Cure Medical LTD Haeshel 7 2nd Floor N Caesarea P MADI IN ISHAR 38900 Israel Tel 972 4 623 0333 Fax 972 4 623 0222 www icecure medical com 220 240 VAC 50 60 Hz 7A MLS3180001 Rev B Figure 3 Label 3 Identification MLS3180001 Rev B CAUTION Js Federal law restricts this device to sale by OT OYL the order al a EASL lari MLS IE Rew B Figure 4 Label 4 Federal laws restriction MLS1000004 Rev B 26 IceCure Medical Ltd DSR3100000 rev M Confidential 2 O 8 SO0000LSTIMN
29. IceSense3 Confidential User Manual Figure 18 Front and back view of the IceSense3 cryoablation system with numbered components 1 2 3 4 5 6 7 8 9 Touch screen Cryoprobe holder Cryohandle Temperature sensor connector Emergency button Rollers Dewar positioning door Handle plug holder Foot pedal connector 10 Foot pedal Not available in some regions e g China 11 On off switch 12 Dewar storage cases The IceSense3 cryoablation system includes Main chassis Adjustable touch screen 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 19 The IceSense3 transportation rollers amp brakes 35 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual
30. LS1000005 Rev C 27 Figure 6 Label 6 High voltage caution MLS1000006 Rev B cccccccccnnnononononannnnconos 27 Figure 7 Label 7 Line voltage danger MLS1000007 Rev B ssssee 27 Figure 8 Label 8 Foot pedal MLS1000008 Rev B esses 2 Figure 9 Label 9 Risk of Explosion MLS1000009 Rev B eene 27 Figure 10 Labell0 Single use probe MLP7000001 Rev F cccccccccnnnnnnnnnononanononnnos 28 Figure 11 Label 11 Single use temperature sensor MLT8000001 Rev G 28 Figure 12 Label 12 Liquid nitrogen Dewar MLS1000001 Rev D 28 Figure 13 Label 13 Black Dewar MLS1000015 Rev A eere 29 Figure 14 Label 14 Cold area MLS1000010 Rev B ooooooooooo occccccccccccccnnnnnannnnnnannnonnnnnos 29 Figure 15 Label 15 Empty LN2 dewars MLS1000012 Rev A occccccccnnnnnnonnononancnnnnnos 29 Figure 16 Label 16 Applied parts MLS1000014 Rev A eene 30 Figure 17 Label 17 Shipping Art WOER uite danna naaa naaa 30 Figure 18 Front and back view of the IceSense3 cryoablation system with numbered components rr Petadiotnedbd er mtd seEbo Eon Pets dH acto adios 35 Figure 19 The IceSense3 transportation rollers amp brakes cccccccnnnnnnnoooonocnnnnoss 35 Figure 20 The Emergency Stop DUTTON essensies ei
31. 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 red circle icon see figure below Figure 38 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 Protocol Time 07 30 Date Jan 24 2014 Time 10 54 AM Treatment Mode Preset Probe IceSense 13 Figure 39 Last Treatment screen 51 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual In this screen you can see details of the last procedure that was performed including date time treatment mode probe type and duration of treatment 5 2 6 General settings The system general settings and technician mode is available by choosing the Settings button on left lower corner of the touch screen Fig below Main Menu Prepare For Treatment Edit Presets Show Last Treatment Settings Ah 50 remaining procedures before maintenance Figure 40 Activating the Settings option from t
32. 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 original sponge lid supplied with the dewar 20 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 diffic
33. ablation system These symbols are listed in the table below Table 1 1 International Symbols on IceSense3 cryoablation system Symbol Meaning Caution Warning Applied parts gt gt Class 1 Serial number Manufacturer Date of manufacture Do not reuse Use by Date Catalogue number Do not resterilize 49g MOLE STERILE Sterilized using ethylene oxide 31 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Symbol Meaning LOT Batch code Contains sufficient for lt n gt test 4 lt 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 Oxygen depleting Oxygen depleting 32 IceCure Medical Ltd DSR3100000 rev M IceSense3 C
34. aintenance Make sure to call IceCure Medical service representatives in time 2 3 Operating warnings 16 gt gt gt IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 must be IN THE TARGET TISSUE BEFORE starting the freeze treatment Warning The practitioner 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 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 17 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning Before removing the temperature sensor from the tissue
35. al User Manual SS M NEMINEM 35 3 22 EMEerSency Stop DULL OM i aid dada 36 3 9 AG K1DIC OSC carr e nase cence sarin E 36 3 3 4 Touch screen and User Manual activatl0D cccccccccnccnnnnnnnonononnnonanannnnnncnnnnns 36 3 9 2 Cryohandle dno CONOPrODE ni 39 2 220 Handle plis NONE a uU eiit eene Ru btt 40 3 3 7 Foot pedal Not available in some regions e g China 40 32 928 zDbemiperature Sensor OVS iio 4 33 9 De wdrstorage Cases co ds iouis ubi vu io dox bes tud 42 34 Operational dell cis 43 2l Sarun A a 43 II A E cto ara lo ceaeniesae aap E E E scented 44 SAS CryOablavion Procedures asilo aliada 45 Se Saa 45 4 INSTALLATION AND SETUP viii 46 4 1 Space and positioning TeQquITeMent S ooooonnnnnnnccnnnnnnnnonnnnnnnnononnnnnnnnnnncnnnnnnnnnnnnnnnnnnns 46 42 Setup warnings and CAU n 46 4 5 Blectrical tequila iii its 47 aa Shipment components nta 47 ko S A T E T A 47 Y OPERATING THE SY S PE Mita a ans 48 S JDxocedute OWEN War dd 48 22 SPrecoperationdl Stand 48 52 1 Pr parme the syster tor procedure iia 48 52 2 Preparing the patient For Procedure di 48 5 2 3 Switching on the IceSense3 M cryoablation system ssssss 49 E A II aaa ars 51 S25 MON Last ECM A is tuo pep sque 51 02 0 ASeneral SA seio assiette hdi dailies 22 3 2 7 Preparing the system tor treatment 54 32405 Tigannenb5elecHOf usato sme Erde ttbdis id 65 Jy o A A E tc
36. 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 M 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 oral cavity rectum and skin
37. ani 24 247 eere hhc H Exprdlz of Cane Gower auxi rea TG Ea Fa Dg Gum NB Gus Gus Gen A GP A A oz E gecs i 79 remaining procedures before maintenance Figure 23 The User Manual Table of contents You can select a page number zoom in or zoom out scroll along the document Sense e S iceCure 4 f E 4 E e 3 t Y 26 1 104 sf 103 y EA E S Sign Comment Confidential User Manual Main Menu E S O 84 S000001 SW 2 Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C Figure 6 Label 6 High voltage caution MLS1000006 Rev B Figure 7 Label 7 Line voltage danger MLS1000007 Rev B OK 28 remaining procedures before maintenance Figure 24 How to scroll along the User Manual By pressing OK you will exit the User Manual IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual If you prefer you can also download the User Manual from our website http www icecure medical com For confidentiality and security reasons the access is protected Please use the Personal Password you received from your IceCure Medical representative 3 3 5 Cryohandle and cryoprobe The cryohandle is situated at the end of the flexible hose that projects through the upper area of the front panel of the IceSense3 cryoablation system unit The cryoprobe is connected to the cryohandle The cryohandle allows for maneuvering of the cryoprobe with
38. arm 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 If temperature reading is still unreasonable continue the 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 a few minutes and try removing it gently 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 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 97 d 2E E a 10 11 12 13 IceCure Medical Ltd DSR3100000 rev M IceSense3 Conf
39. ature sensor cable connector gt che i Temperature sensor connection site If you decide to use a temperature sensor connect it per the following instructions while maintaining sterility 1 Remove the temperature sensor from the sterile package 41 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 4 Under imaging guidance insert the tip of the temperature sensor into the tissue you want to measure 5 Atthe end of the procedure gently remove the temperature sensor from the tissue and discard it 00 38 Skip Warm Manual robe 013 DO NOT DISCONNECT Temp 18 7 Figure 30 Temperature display of sensor in the procedure screen green arrow Warning Temperature sensor insertion and navigation within tissue MUST be done under guidance of an appropriate imaging device 3 3 9 Dewar storage cases The Dewar storage cases are located at the back of the chassis They provide storage for the Dewars When placing the Dewars inside the storage cases make sure they are well in stored see fig below o Correct way Figure 31 Dewar storage cases the correct way to put the Dewars inside the storage cases 42 IceCure Medical Lt
40. cal service If Dewar cannot be removed close the door and contact 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 and call IceCure Medical service Ensure that the probe is fully inserted can t screw it any more with reasonable force If next button doesn t 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 service 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 Warm button and contact IceCure Medical service Check that the temperature sensor is well connected If so change the temperature sensor 96 IceCure Medical Ltd Confidential Problem Cryoprobe 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 M Probable Cause W
41. cle Treatment using Manual Mode urrent step Elapsed Time Freeze 00 04 Freeze Elapsed 00 04 I E Thaw Probe 24 DO NOT DISCONNECT 00 04 Figure 61 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 72 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Treatment using Manual Mode Current step Protocol Thaw 01 07 Freeze 9 Warm Probe 015 DO NOT DISCONNECT Temp NA Figure 62 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 e Pressing the Treatment using Manual Mode Current step Protocol Warm 00 00 Finish Probe 013 DO NOT DISCONNECT Temp NA Figure 63 Warm screen in Manual Mode 73 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual During the manual procedure the system provides information regarding treatment progress The left side of the screen displays the Current Step freeze thaw or warm cycle and time elapsed for this specific step The right side of the screen displays information on the entire Pr
42. con 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 53 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 5 2 6 3 Export Log This screen allows you to export any procedure data to a USB removable storage device in an easy and convenient way When you press the Export Log icon a popup window appears with the 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 Zone Internet Time Date Time i xs s 11 32AM Current time zone Coordinated Universal Time i Cancel Figure 43 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 o
43. creen c ooooooccccocoooonooonnnonnnnnnnnnonononononoss 51 Figure 59 East Treatment Sr eB ia 51 Figure 40 Activating the Settings option from the Main Menu screen 22 Figure 41 The Setas Or isla tn 32 Figure 42 The Change Workflow screen with two alternative workflow settings 53 Figure 43 The Windows Date and Time Properties screen oooooocooconooonononnnnononnnnonononnnnos 54 Figure 44 Preparing the system for treatment by pressing Prepare for Treatment green arrow on Main Vientre ii 55 Pisure 45 The Dewar preparation CEM Pepe DH IS teste up qinedies 55 Figure 46 Iceball isotherms of IceSense3 cryoprobe from experiments in gel at room IS HOT M T 60 Figure 47 The cryoprobe the figure is for illustration only eeeeeesessesssss 60 Figure 46 Crvoprobe TCOTSIEALOTESCEGODD eden 61 Figure 49 Crvoprobe connection Srl ia 61 Figure 50 Functional test iii dde 63 Figure 51 Functional test visual inspection screen eee 64 Figure 52 Treatment Selection Crecen 65 Figure 53 Define a treatment protocol by choosing Edit Presets on the Treatment Selection screen green arrow or in the Main Menu screen yellow arrow eeeeeeeeees 66 Figure 54 Editing an existing protocol green arrow or adding a new one yellow arrow T EE 66
44. cure medical cow Caution Federal law restricts this device to sale by or on the order of a physicianz MLT8000001 Rev G Figure 11 Label 11 Single use temperature sensor MLT8000001 Rev G iceSense ocre IceSense3e 7 IceCure Liquid Nitrogen Dewar Liquid Nitrogen Dewar PMT1000105 PMT1000101 YYYYMMDR YYYYMMDD C th A Feu a Pi A Wy Wa y J N Nf d MN a sufficient for one Oxygen Depleting sufficient for one Oxygen Depleting procedure only s procedure only Caution Handle with care Caution Handle with care Figure 12 Label 12 Liquid nitrogen Dewar MLS1000001 Rev D IceCure Medical Ltd DSR3100000 rev M Confidential USE IceSense3 BLACK DEWAR ONLY MLS1000015 REV A Figure 13 Label 13 Black Dewar MLS1000015 Rev A H 24 01000015714 Figure 14 Label 14 Cold area MLS1000010 Rev B Figure 15 Label 15 Empty LN2 dewars MLS1000012 Rev A IceSense3 User Manual 29 IceCure Medical Ltd DSR3100000 rev M Confidential Figure 16 Label 16 Applied parts MLS1000014 Rev A V 9 amp VLOOOOLS IW 1060 hPa 500 A Figure 17 Label 17 Shipping Art Work IceSense3 User Manual 30 IceCure Medical Ltd DSR3100000 rev M 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 cryo
45. d DSR3100000 rev M 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 Maintenance of liquid nitrogen should be performed by authorized personnel 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 t
46. d cs 68 5 3 1 Safe Operation in Percutaneous Procedures oooooncnnnnnnnncnononnnccnnnnnnnnnnnnanonnnos 68 A A A 68 A ecc E ES 70 3 9 4 i Pause ODHOHRB aieo dria vede iem AEA A 70 So MEM PN 75 O ACUVE Warm D OCE Sua 75 5 3 7 Replace the Dewar during a CryOprOCOdULE oooocnccnccnnnncnnnnnnnonnnnnnnnnanonnnnnnnnnnoss 71 a a E NA RIDE TINI AN AP ERI 82 5 4 1 Removing the temperature sensor from tISSUE cccccccccnnccnnnnoononnnnonnnancnnnnnnos 82 5 4 2 Removing the cryoprobe from the cryohandle ooooooooononconncnnncnnnnnoss 82 5 43 Disassembling the temperature SeNSOT ooooooonnnnncccccnnnnnnnnnnnnnononnnnnnnnarnnnnnnnnnnoos 83 5 4 4 Exiting the IceSense3 M cryoablation system treatment mode 83 Vibe c Beg NU UTERINE NR 84 5 521 IceSense3 cryoablation system failures its 84 5 5 2 IceSense3 cryoablation system touch screen failure 85 0 COMPUTERINTEREAC E eae th dane anes enna spl deuda 87 Gel Lie Technician menta 87 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 02 AREAS MES ole tito 87 OM Pans oiie AA e PO OR E 87 A E a e OU E E E E 88 A A e e IIA 88 6 3 2 Warning messages ooooooccccccnnnnnnnnnnnnnnnnnnononnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnss 88 Coo ss A e OE A TE 89 1 ACCESSORTES e 91 MEME OUI rra 9 TJ Amele use sterio COPOS iento 91 7 2 The foot pedal Not available in s
47. d 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 notify 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
48. d prepare the new Dewar that was entered The screen will show Proceeding please wait figure below imeanment opesset O 00 O5 00 58IL0 sel se3 re Replacement done Proceeding Please wait Thaw Time 04 18 Probe 13 DO NOT DISCONNECT Figure 69 The replacement done follow up screen e When preparation of the new dewar is complete the system will come back to the Thaw cycle figure below e To goto the next freeze cycle you have to press skip even if the time to complete the replacement exceeded the preset Thaw time figure below 79 IceCure Medical Ltd Confidential Warning DSR3100000 rev M IceSense3 User Manual If you don t press skip after replacing Dewar the system will stay in Thaw mode Treatment preset 07 00 04 00 07 00 Thaw 00 52 Skip Probe 13 DO NOI DISCONNECI Protocol al Protocol Time 18 00 Ihaw 03 07 00 00 E Warm Manual Figure 70 Replacement was completed before the Thaw ended treatment preset 0O5 00 05 00 086 0 05 00 07 GCs Current step Thaw 1 Skip Probe 24 DO NOT DISCONNECT cm x Protocol Elapsed Total Protocol Time 30 00 10 00 INIA 05 00 Thaw 06 06 1l 00 00 Thaw 00 00 00 00 Warm 00 00 E Warm Figure 71 Replacement was completed after the Thaw ended 80 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 5 3 7 1 Replace the Dewar du
49. 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 not supplied by IceCure Medical in single use packaging 93 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual The sleeves are used to cover the flexible hose up to the cryoprobe and to cover the touch screen the cover is used for the cryohandle holder 8 3 Periodic servicing Caution The IceSense3 cryoablation system is not user serviceable Refer all service issues to IceCure Medical s Customer Service Department If there is any malfunctioning of the IceSense3 cryoablation system please contact IceCure Medical technical support The technician should disconnect the system from the electrical outlet before removing external covers of the system 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 Settings Figure 84 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
50. 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 including lung tissue 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 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual e You are a board certified medical practitioner licensed in your country 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 clinical us
51. e 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 Elapsed Total Protocol Time 07 30 02 36 az Safe to disengage the probe from the handle Main Menu Figure 75 Protocol Completed screen Pressing on the Main Menu icon green arrow will load the Main Menu screen 83 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Main Menu Select Treatment MELELE Protocols Show Last Treatment Settings 50 remaining procedures before maintenance Figure 76 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 84 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Sensor out of expected range Do not use the system and contact tec
52. e 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 maintenance and repair of the system IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning Do not modify this equipment without authorization of the manufacturer 1 7 Advanced Operator You are a qualified IceSense3 cryoablation system advanced operator only if you meet all of the following criteria e You have taken a certified IceSense3 cryoablation system technical 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 for presentation or other marketing use 10 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 SAFETY NOTES While this manual is
53. eeze 00 00 15 04 56 1 lala lala E Replace Dewar OK gt Probe 13 DO NOT DISCONNECT Figure 66 Replace Dewar option question 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 below TI IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual e If you don t press either button the message will disappear shortly before the end of the Thaw cycle imneaiment pse88 O D0 05 D00 B48J0 Current step Protocol Elapsed Total Protocol Time 19 00 08 27 01 27 Freeze 15 00 00 03 32 E Lowering the Dewar Please wait Probe 13 DO NOT DISCONNECT Figure 67 Lowering the Dewar e The system will perform several steps then it will inform you that it is safe to replace the Dewar and you will get the Replace Dewar screen figure below Please enter a full Dewar instead of the old one and only then press ok to continue e Atthe same time you will get an interactive update of the thawing time 78 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Maeanmnent opeset O 7 00 05 00 8 010 Replace Dewar Replace the Dewar and press OK to continue ao Thaw Time 03 47 Inm OK Probe 13 DO NOT DISCONNECT Figure 68 The replace Dewar screen and press ok to continue e After pressing the OK button the system will proceed an
54. ensors 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 affects the mechanical performance and microbiological properties of the product Warning After finishing the surgical procedure on a patient remove 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 Any used cryoprobe and temperature sensor should be related as used sharp biohazard waste 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 2 5 Emergencies and errors 2 5 1 Emergency Stop button 22 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Caution Only push the Emergency Stop button when there is NO other choice Whenever 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 major electrical risk is detected during the cryotherapy procedure PUSH the Emergency Stop button immediately 2 5 2 Emergencies causing
55. er completion of treatment of a given patient make sure that the single use cryoprobe and single use sterile sleeve are removed and discarded 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 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 5 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 water saline e Insert the cryoprobe into the container and press the Action button on the handle or Test on the touch screen 62 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Preparefor Treatment Test Cancel Probe 013 DO NOT DISCONNECT Figure 50 Functional test screen e The system will check essential parameters e A failure of any internal test will result in an error message displayed on screen Please record the error number and follow system instructions until you are requested to remove the probe safely from the cryohandle You will then be returned to the Main Menu screen Contact IceCure Medical technical service After successful internal test the system
56. erred 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 in its use 2 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 Never hesitate to contact an authorized IceCure Medical representative for further information and clarification before using the system 12 IceCure Medical Ltd DSR3100000 rev M 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 cryoab
57. eset screen 67 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 Preset 01 Preset 02 Preset 03 Preset Preset Preset Preset Preset Preset Manual Edit Presets Main Menu Probe 013 DO NOT DISCONNECT Figure 57 Choosing the Manual Mode option green arrow 5 3 Operational stages 5 3 1 Safe Operation in Percutaneous Procedures When performing percutaneous cryotherapy procedures meticulous observation of the incision site and the skin overlying the treatment site is required 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 saline or local anesthetic between the skin and the ice ball formation and placing moist gauze between the skin and the cryoprobe 5 3 2 Preliminaries Before operating IceSense3 cryoablation system make sure you have completed all pre operational stages Warning Insertion of the cryop
58. ewar 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 followed 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 pressure can damage the container Do not seal the containers tightly
59. he 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 Ah 4 Change Technician Export Workflow mode Log Back y 50 remaining proceedures before maintennce Figure 41 The Settings screen 52 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User 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 42 The Change Workflow screen with two alternative workflow settings 5 2 6 2 Log in to Technician mode Choosing the Technician Mode i
60. he following screen will appear 43 IceCure Medical Ltd DSR3100000 rev M Confidential Loading IlceSense3 System Estimated time to complete 00 38 Figure 32 The system is loading screen Wait for the Main Menu screen to load NET a lO Select Treatment MENE Protocols Show Last Treatment Settings 90 remaining procedures before maintenance Figure 33 The Main Menu screen 3 4 2 System pre tests IceSense3 User Manual As the system uploads several internal built in tests are performed automatically in order to verify that the system is safe for use Additional specific tests will be made upon visual inspection by the user following instructions on the graphic interface Each probe must be tested before use 44 IceCure Medical Ltd DSR3100000 rev M 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 entire procedure 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 cryopr
61. hnical support Error 911 Figure 77 System Fail example screen 2 If you 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 Dewar the system instructs you that it is safe to do so 4 If system shut down is required shut off the IceSense3 cryoablation system by pressing the mechanical ON OFF button on the main chassis and then remove the plug from the power supply 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 electrical emergency 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 85 IceCure Medical Ltd DSR3100000
62. i Ea EE 36 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Figure 21 The touch screen display before a cryoablation procedure 37 Figure 22 The User Manual Srila das 37 Figure 29 The User Manual Table Or CONTENTS ua 38 Figure 24 How to scroll along the User Manual sees 38 Figure 25 The flexible hose cryohandle and connected cryoprobe 39 Figure 26 The 90 degrees cryohandle and connected cryoprobe Not available in some recons CB USA Td uada udis A uso di aont Ead Tod A cd ied OERI 39 Figure 27 Handle plug holder and handle plug ud 40 Figure 28 The foot pedal dedo 40 Figure 29 The temperature sensor and its components ssssssssssesersrrerererrreererrererrrrerreen 41 Figure 30 Temperature display of sensor in the procedure screen green arrow 42 Figure 30 Dewar storage cases the correct way to put the Dewars inside the storage O A T TE EERPEN 42 Figure 32 The systemts Joading Serce di 44 Firu 55 he Mat Menu Sero e err din 44 Figure 34 Schematic illustration of placement of the system and patient 49 Figure 35 The system 18 loading ral 50 Figure 36 The Main Menu screen esses nennen rennen 50 Figure 37 The Action button as displayed on screen several of the options 51 Figure 38 The active Warm button as displayed on s
63. idential 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 safe 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 Enter the probe serial number Each procedure must be carried out with a new sterile probe Press on the Next button on the screen 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 message will appear Please wait until the system is ready for test When the system is ready place the probe inside a sterile Saline or water cup Press Test 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 If the test was successful press Success If not start over with a new sterile probe if required Procedure Select treatment modality Preset Cycles Manual Mode You can modify the cycles as needed during procedure Insert the probe to the tissue and navigate with the help of Ultrasound to stub through the lesion center Act
64. in the target tissue Figure 25 The flexible hose cryohandle and connected cryoprobe Flexible hose Cryohandle Action button allows the user to select actions that appears on the screen Warm button activates deactivates the warm function Cryoprobe insertion point LED indicator displaying BLUE to indicate the freeze mode is ON A d Moe x Cryoprobe Figure 26 The 90 degrees cryohandle and connected cryoprobe Not available in some regions e g USA 1 Cryohandle 2 Cryoprobe 39 IceCure Medical Ltd DSR3100000 rev M 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 Humidity is a crucial issue to address in cryosurgery systems e After every procedure close the handle plug on the Cryohandle e Perform pretest at close proximity to the procedure treatment Figure 27 Handle plug holder and handle plug 3 3 7 Foot pedal Not available in some regions e g China The pedal is an alternative to the Action button on the cryohandle pushing the pneumatic foot pedal is identical to pushing the Action button Figure 28 The foot pedal
65. 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 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 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 24 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 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 DAN
66. ivate 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 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 continue the warm process by pressing Warm and try again to gently remove the probe e If you press Warm more than two times the following message may appear 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 15 Safe to disengage the probe from the handle 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
67. lation 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 Warning The handle and hose portions of the IceSense3 cryoablation system may become cold during the cryoablation procedure Operators should consider insulating these parts in order to prevent discomfort to the patient Warning The supplier and manufacturer of the IceSense3 cryoablation system do not claim that it will be useful for assisting with the treatment of any particular condition or set of circumstances Full responsibility for assessing the potential benefit of the system for a given medical condition lies with the practitioner 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 13 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning Do not rely solely on the temperature sensor measurement Always
68. llow the detailed instructions on open the Dewar storage when you want to replace a Dewar e The Dewar must be completely filled prior to each procedure e The Dewar must be completely filled prior to each refill e The Dewar should never be 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 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 liquid nitrogen Dewars should be performed by authorized personnel only e Check that the Dewar is fully filled see the arrow on the screen and cover it with its 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 AN 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 N Warning Do not transfer a Dewar with Liquid nitrogen unless it is covered with its designated lid e Take off the lid and place the Dewar in its position into the system 56 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confiden
69. m instructions until you are required to safely remove the probe from the cryohandle e 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 e Choosing Success will load the treatment selection screen e fforany 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 start active Warm if possible If not wait for passive Thaw In both cases use skin protection techniques 64 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual AN Warning During pre test portions of the cryoprobe other than the freeze zone including the plastic cover that is located near the cryoprobe handle may become cold due to malfunction If unwanted freezing occurs stop the pre test process by pressing Cancel N Warning Pay attention to the probe during pre test bubbles leak or frost on shaft may signal internal problems that could be hazardous 5 2 8 Treatment Selection The system allows you to choose between manual mode and automatic mode using preset protocols To choose automatic mode select one of the preset protocols from the Treatment Selection screen a
70. may occur in the vicinity of equipment marked with the follaurina eumpbol 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 absui puuii 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 relocating the model IceSense3 Cryotherapy product b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3V m 104 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING Recommended separation distances between portable and mobile RF c
71. 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 equipment in the clinic room Caution The IceSense3 cryoablation system must be unpacked installed and tested by an IceCure Medical authorized technician only Caution There are no user serviceable parts in the system Refer all service issues to IceCure Medical s Customer Service Department Caution Make sure the time is set according to local time zone before executing a cryotherapy procedure 14 gt gt b bb IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 2 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 IceSense3 cryoablation system is a dedicated system part and should not be used for any other purpose Make sure to use only the adequate Dewar for you
72. obe tip is heated by warmed Nitrogen gas enabling fast and safe removal of the probe 45 IceCure Medical Ltd DSR3100000 rev M 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 chapter 11 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 Caution 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 46 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual
73. ocess under ultrasound 74 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual mmesument peset 0O2 00 0 1 COU Se10 Current step Elapsed Total Protocol Time 07 00 02 34 02 34 00 00 00 00 15 01 25 4 00 00 Skip Warm Manual Probe 24 DO NOT DISCONNECT Temp 157 5 Figure 64 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 format and changes you have made if any to the preprogrammed protocol 5 3 5 Thaw During Thaw the iceball melts partially or totally depending on the thaw time and the tissue properties It is clinically important to have a thaw cycle between two freeze cycles and to keep the probe location steady in the target tissue during all of the thaw period Control the process under Ultrasound or any other imaging system 5 3 6 Active warm process The active warm step occurs at the end of every treatment Its purpose is to allow the cryoprobe s removal from the target tissue in the fastest and safest way e To activate the Active warm press on the Active warm button on the cryohandle or the Warm icon on screen as pre
74. ome regions e g China 92 7 3 The temperature sensor Not available in some regions e g China 92 SS PXSLEM MAINTENANCE cosssassietcesdidiesattesidvs E dnos ab ad gts bendi a 93 8 General cleaning oooooooonnnnnnnnccnnnnonononnnonononononononnnnnnnnnnnnnnnnnnnnnnnnonnnnnnnnanannnnnnnnnoss 93 MEME A mmm 93 5 9 PeOrodie SECO rta 94 2 56087508 SHOOTIN m P rar verre er reenen PeneerTtrene rn enter arr eerree were rete rer 95 JUMEMEC 1 re rer rere ener re eer nee eer ee eer tn ee rte 95 92 Troubl shooting guide sia as 95 10 IceSense3 M cryoablation system Step by Step procedure occcccccccnccnnnnnnnnnnnnononos 98 IT ASE MES PECIPECATION S isso vEPbUNI ME asc E PADRE 99 12 LIMITED WARRANTY CERTIFICATE eene 100 IS CUSTOMER COMPLATNTEOR Mecano 101 l4 REPORTCUS TOMEN COMPLARNE serseri 102 16 Manufacturer s Declaration of the EUT oonnnnnnnncnucucoooooonnnnnnnnnoncnnnnnnnnnannnano non nnnnnnos 103 Figures Figure 1 Label 1 On Off mechanical button MLS1000002 Rev B 26 Figure 2 Label 2 Emergency Stop MLS1000003 Rev B ccccccccccccncnonacananananonononoos 26 Figure 3 Label 3 Identification MLS3180001 Rev B ooooo occccccccccccccccnnnnnnnannoanonnnnnos 26 Figure 4 Label 4 Federal laws restriction MLS1000004 Rev B 26 Figure 5 Label 5 Follow instructions for use M
75. ommunications equipment 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 105
76. onfidential User Manual Symbol Meaning This side up Authorized representative in the European community CE mark mandatory conformity mark for products placed on the market in the European Economic Area 1060 hPa 500 A Transportation and storage atmospheric pressure limits 90 S Transportation and storage humidity limits 70 C 158 F 0 C 32 F Storage temperature limits l7 Tem ri a Keep away from sunlight 33 IceCure Medical Ltd DSR3100000 rev M 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 34 IceCure Medical Ltd DSR3100000 rev M
77. ork 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 48 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 Measure with an imaging device 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 IceSenses System Ssistant Surgeon Figure 34 Schematic illustration of placement of the system and patient Warning AN 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 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 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
78. otocol 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 4 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 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 move from the automatic mode AT ANY TIME by pressing the Manual mode button on the screen without interrupting the procedure When in Manual you can t go back to Automatic mode 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 pr
79. ouch 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 an adapted container Following a cryosurgical procedure it is recommended to wipe the pedal 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 Check the main unit for any remaining blood or tissue In case these remnants are detected wipe the infected area with gauze Pads soaked with 70 alcohol Verify that no visible remnants remain Wipe the initially cleaned area with approved Medical professional surface disinfecting wipes and dry it in alr 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 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
80. ow Sense e 7 O Prepare for Treatment I CeCure cure Dewar Probe S N zonnec DE Functional Test o Connect the probe and press Next A 2 Next Cancel O Ensure sterility according to medical standards Figure 79 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 87 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 System mode 3 Wizard Instruction bar 4 Main interaction area 5 Icons 6 Status display 6 3 System messages Messages can appear in one of three modes status warning or error messages 6 3 1 Status messages Information that is valuable to the user will appear in the status bar area at the bottom of the screen 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 Mesalment opsset D 1 30 0 1 3004 Elapsed Total Protocol Time 04 30 00 32 MA 15 00 57 Skip Manual Probe 34 DO NOT DISCONNECT Temp 85 2 Figure 80 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 88 IceCure Medical Ltd DSR31000
81. 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 allowed to do so by the system Failure to do so will increase the risk of liquid nitrogen related accident 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 23 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning When the system shuts itself down due to an error contact IceCure Medical and describe the error message shown on the screen as precisely as possible Do not attempt to reuse the system before contacting IceCure Medical After reporting or making note of the error 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
82. r system 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 Make sure to use only the adequate Dewar for your 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 15 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning 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 m
83. rder 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 replacement 54 IceCure Medical Ltd DSR3100000 rev M 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 Main Menu Prepare For Treatment Edit Presets Show Last Treatment Settings Ah 50 remaining procedures before maintenance Figure 44 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 below Preparefor Treatment y Dewar Probe S N Connect Probe Functional Test a Ly m Cancel Figure 45 The Dewar preparation screen 55 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Filling the Dewar Caution Fo
84. rev M IceSense3 Confidential User Manual Figure 78 The Emergency Stop button located on the main chassis green arrow Warning If an electrical hazard is detected at any time PUSH the Emergency Stop button immediately Caution Push the Emergency Stop button ONLY when there is NO other choice Wherever possible the system should be shut down by the standard procedure Excessive use of the Emergency 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 If emergency stop button was accidently pushed the procedure is cancelled but can start again with a new probe 86 IceCure Medical Ltd DSR3100000 rev M 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 bel
85. ring Freeze In case of low Nitrogen the system can t continue to Freeze So it will ask to refill the Dewar in Freeze cycle see fig below T Wwaaiainde 0240 00 gt 40 050 0620 20 60 Current step Protocol Elapsed Total Protocol Time 30 15 15 12 Freeze o e Freeze 05 12 03 02 E Freeze 00 00 15 Dewar is empty Would you like to replace and switch to manual mode 00 00 Probe 24 DO NOT DISCONNECT Figure 72 Replacement during Freeze in case of empty Dewar e If you press OK you can replace a full Dewar and continue the procedure When pressing OK the system will move to Manual mode and be in a Thaw cycle Pay attention that in Manual mode you need to press the icon on the screen for each freeze or thaw cycle e Replace Dewar as in paragraph 5 3 7 e f you press cancel you will end the procedure see figure below Protocol Low Nitrogen Freeze cycle stopped due to low Nitrogen level Press Warm for quick probe release Press Finish AFTER extracting the probe Finish Probe 24 DO NOT DISCONNECT Figure 73 procedure stopped due to Low Nitrogen IceCure Medical Ltd DSR3100000 rev M 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
86. robe into the target tissue is performed under the guidance of an appropriate imaging device and by an authorized practitioner trained by IceCure medical 68 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Warning You must NOT allow the freeze process to start before the cryoprobe tip is actually within the target tissue Before activating the freeze cycle insert the cryoprobe into the target tissue according to the following steps 1 Plan the trajectory of the probe prior to placement The center of the cool zone shall be along the longest dimension of the target tissue if required parallel to the chest wall in breast applications 2 In percutaneous procedures insert probe under ultrasound guidance or other appropriate imaging guidance e Confirm longest dimension of the target tissue e Perform a 3 mm skin incision for example using 11 blade Position the tip of the cryoprobe minimally 4 mm beyond the distal edge of the long axis of the target tissue For optimal probe positioning please note the following Probe 3 4Long 20mm from needle tip Probe 3 4 Small 12mm from needle tip Probe 2 4Long 14mm from needle tip Probe 2 4 Small 10mm from needle tip 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
87. s shown below Type of treatment is determined by the number and duration of freeze and thaw cycles and depends also on the practitioner s preferred way of work Manual Edit Presets Main Menu Probe 013 DO NOT DISCONNECT Figure 52 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 above 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 65 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual nt Selection Select a preset protocol or Manual mode Prepare For Treatment Preset 01 Preset 02 Preset Edit Presets Show Last Treatment Preset Preset n Settings Manual Edit Presets Probe 013 DO NOT DISCONNECT Figure 53 Define a treatment protocol by choosing Edit Presets on the Treatment Selection screen green arrow or in the Main Menu screen yellow arrow Choosing either option will open the Preset Setup screen and you will be able to add a specific protocol by pressing one of the empty
88. 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 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 The foot pedal action is equal to the action of the BLUE button 7 3 The temperature sensor Not available in some regions e g China 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 92 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 8 SYSTEM MAINTENANCE 8 1 General cleaning Warning Do not allow any liquid or humidity to enter the cryohandle Always keep the cover on the cryohandle Following each cryosurgical procedure discard the single use devices single use cryoprobe single use temperature sensor cryohandle cover and sleeves for the flexible hose and t
89. tial User Manual 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 5 2 7 1 Sterile sleeves After filling the Dewar and placing it in its compartment please work within sterile conditions 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 2 Cryoprobe Selection Select a cryoprobe according to your clinical judgment and target tissue The iceball size is a function of the freezing time and is also affected by the tissue and blood flow Large probe creates oval iceball while small probes creates rounder iceball Always monitor the iceball growth with adequate imaging techniques Dd IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 4 SHORT AC 4C a mm mm mm mm mm mm PES le el 2 4 Short 2min 2min se we we m a mm
90. tioning the probe in the tissue or injecting saline for example Using the pause option should be as minimal as possible While using the pause button freezing mode is disabled therefore is not calculated in the total freezing cycle time 70 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Pause 7227 mc Skip Manual Probe 4567 DO NOT DISCONNECT 07 31 Skip Manual Probe 4567 DO NOT DISCONNECT Figure 59 Pause and Play buttons during the freeze cycle The pause time does not affect the freeze preprogrammed time but depending on when and how long the pause time is defined it may affect the iceball size The physician should always monitor the iceball size during the whole procedure IceCure Medical recommends is to use Pause only if necessary 5 3 4 1 Manual freeze mode Choosing the Manual freeze mode will open the treatment screen for manual mode as show in Fig below 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 71 IceCure Medical Ltd DSR3100000 rev M Confidential Treatment using Manual Mode Current Step Protocol Elapsed 00 00 Ready Back Freeze Probe 013 DO NOT DISCONNECT IceSense3 User Manual Temp 100 Figure 60 Manual Mode screen press on Freeze to start the freeze cy
91. to call IceCure Medical service representatives in time 94 gt IceCure Medical Ltd Confidential DSR3100000 rev M 9 TROUBLESHOOTING 9 1 General Warning IceSense3 User Manual Do not modify this equipment without authorization of the manufacturer Warning Never open the console Only an IceCure Medical technician or authorized representative is allowed to open the console for maintenance or to repair the system Warning Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide Any malfunction not listed in the guide or one that persists after the recommended action has been taken must be referred to IceCure Medical 9 2 Troubleshooting guide Problem Main chassis does not move No system power AC power is on but the screen does not turn on Dewar compartment door does not open Probable Cause Wheels are locked AC power is not connected to the system power supply malfunction Computer power supply malfunction or computer error Door held shut by magnet Action Unlock the wheels transport the system and lock them 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 Emergency button is released Check that main switch is ON If still there is no power contact IceCure Medical service Check if the computer power cable
92. tomer complaint To be filled by customer complaint recipient Initial Disposition O Customer Complaint Service Call Activity in case of two dispositions please fill SC form FQM 75 005 0 The No will be filled by QA Reported by O Phone O FAX Ll Email O Letter LJ Sales representatives L Website Distributer O Other Company Name Title Position Address Phone Fax Product Name Please include all machine probes and TS used Batch No Serial No SW Ver Is a sample available O Yes O NO U Picture O Other Please assign RMA and Tag to the sample sent Is sample disinfected according to WI 1036 utilization of Probe after Field Return clinically used O Yes O NO O NA Complaint occurred during O Installation 1 pretest procedure O follow up O Other Descri ption of complaint Please include SW used in the case Was clinical procedure completed Yes O NO LJ NA Please describe the clinical procedure Type of malfunction LJ System Ll Software L Probe O Dewar LJ Transportation O Other Initial consequences U No Harm Ll Injury Ll Death If death or injury occurred please describe below Complaint recorded by Name Title Position On Date Click here to entera Time date Signature ATTENTION IF DEATH OR INJURY OCCURRED NOTIFY IMMEDIATELY TO ALL RELEVANT PERSONNEL ACCORDING TO PROCEDURES 101 IceCure Medical Ltd DSR3100000 rev M Confidential 14 REPORT
93. ulty 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 procedure on a new patient the Dewar MUST be completely filled and placed in the system as described in section 5 2 7 1 of this manual 2 4 5 Burn hazards The Cryoprobe tip can reach very low temperatures Warning Portions of the cryoprobe other than the freeze zone including the plastic cover that is located near the cryoprobe handle may become cold and cause tissue damage If unwanted freezing occurs stop the pre test process by pressing Cancel Warning Portions of the cryoprobe other than the freeze zone including the plastic cover that is located near the cryoprobe handle may become cold and cause tissue damage If unwanted freezing occurs immediately stop the freezing process To prevent injury cryoprobes must be closely observed during use for signs of unwanted freezing 21 A IceCure Medical Ltd DSR3100000 rev M 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 s
94. viously shown e The Warm screen will be displayed and a time count will appear 75 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual e Atthe end of the warm step a message will be displayed on screen informing the user that the warm cycle is done for example 40 50 seconds for 2 cm iceball e Wait for the message then gently remove the cryoprobe from the target tissue and then press Finish Do not force removal of the cryoprobe from the tissue as it might increase the risk of hematoma e fthe 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 from the tissue press the Action button on the cryohandle or the Finish icon on screen to complete the procedure 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 e The system will then perform several verification steps and it will inform you when it is safe to disengage the probe e Incase the active Warm process isn t available wait for passive Thaw Treatmentusing preset 1 30 4 30 4 30 ceCure re otal Protocol Time 07 30 Elapsed 00 50 Press Finish AFTER extracting the probe Figure 65 The Active warm screen during procedure e Instruct patients o To
95. 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 e llustrations of potential functional failures will appear on screen Please refer to these illustrations while inspecting the cryoprobe 63 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual Prepare for Treatment a a gt L al 4a ed al ry iale Inspect uie D ope INIT alg tha als ri Ta press tne appropriate ri ala VULLUTI Bubbles a Frost on Shaft Elapsed 00 00 Probe 013 DO NOT DISCONNECT Cancel Figure 51 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 foam or any unusual appearance 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 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 e fa functional problem occurs as represented by one of the pictures press on the relevant picture e Follow syste
96. y 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 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 syster while the Dewar compartment is open Warning Do not transfer a Dewar with Liquid nitrogen unless it is covered with its designated lid Caution Follow the specific instructions on how to fill and transfer a Dewar as described in section 5 2 7 1 Dewar 19 IceCure Medical Ltd DSR3100000 rev M IceSense3 Confidential User Manual 2 4 3 Voltage and power ratings Caution Verify that the IceSense3 cryoablation system complies with the local voltage line 2 4 4 Liquid nitrogen Safety Warning Liquid nitrogen may cause serious injury or burn if handled improperly Local laws and safety rules regarding the maintenance and handling of liquid nitrogen Dewars should always be observed 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 D

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