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IceCure Medical Ltd.

DSR3000000 rev.L

Confidential

User Manual

100

IceSense3™

REPORT CUSTOMER COMPLAINT

Send to:

IceCure Medical, Inc.
498 Halle Park Dr., Ste. 102
Collierville, TN 38017

[email protected]

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

[email protected]

Tel: +972-4-623 0333;
Fax: +972-4-623 0222

MedNet GmbH – Authorized Representative of IceCure Medical Ltd.
Borkstraße 10
48163 Münster
Germany
Tel +49 (0) 251 32266-0
Fax +49 (0) 251 32266-22

Содержание IceSense3

Страница 1: ...e 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 IceCure Medical Ltd HaEshel 7 2nd floor Southe...

Страница 2: ...18 2 4 3 Voltage and power ratings 19 2 4 4 Liquid nitrogen Safety 19 2 4 5 Burn hazards 20 2 4 6 Grounding 21 2 4 7 Sterility 21 2 4 8 Mechanical handling of flexible hose and cryohandle 21 2 5 Emer...

Страница 3: ...2 7 Preparing the system for treatment 51 Treatment Selection 60 5 3 Operational stages 63 5 3 1 Safe Operation in Percutaneous Procedures 63 5 3 2 Preliminaries 63 Once you have verified the probe i...

Страница 4: ...00004 Rev B 25 Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C 26 Figure 6 Label 6 High voltage caution MLS1000006 Rev B 26 Figure 7 Label 7 Line voltage danger MLS1000007 Rev B 26 Figur...

Страница 5: ...igure is for illustration only 55 Figure 44 Cryoprobe registration screen 55 Figure 45 Cryoprobe connection screen 56 Figure 46 Functional test screen 58 Figure 47 Functional test visual inspection sc...

Страница 6: ...xit icon green arrow 80 Figure 74 The Emergency Stop button located on the main chassis green arrow 82 Figure 75 A sample touch screen 84 Figure 76 Status message example 85 Figure 77 Warning message...

Страница 7: ...ogy 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 a...

Страница 8: ...f warts or lesions The system may be used for the palliation of tumors of the oral cavity rectum and skin The system may be used for ablation of breast fibroadenomas Thoracic Surgery The system may be...

Страница 9: ...e3 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 wi...

Страница 10: ...g 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 a...

Страница 11: ...se 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 unc...

Страница 12: ...on 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...

Страница 13: ...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 t...

Страница 14: ...ated system part and should not be used for any other purpose Caution Dewars should always be stored with their lids in place Caution Only Dewars and lids supplied by IceCure Medical may be used with...

Страница 15: ...moving 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 bo...

Страница 16: ...ioner 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 h...

Страница 17: ...l 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 num...

Страница 18: ...nic 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 ane...

Страница 19: ...quid 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 nitro...

Страница 20: ...be evacuated and ventilated immediately Anyone experiencing headache dizziness difficulty breathing or other symptoms of hypoxia should receive immediate medical attention Do not use a liquid nitroge...

Страница 21: ...ical 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 sl...

Страница 22: ...p button may damage the system Warning If a liquid nitrogen leak is detected during the cryotherapy procedure PUSH the Emergency Stop button immediately 2 5 2 Emergencies causing procedure halt Warnin...

Страница 23: ...hat 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 2...

Страница 24: ...Read User Manual before use Label 6 CAUTION HIGH VOLTAGE Before working on this unit Switch off power supply Disconnect all plugs Label 7 DANGER Line voltage Label 8 Foot pedal Not available in some r...

Страница 25: ...er Manual 25 IceSense3 System Labels Figure 1 Label 1 On Off mechanical button MLS1000002 Rev B Figure 2 Label 2 Emergency Stop MLS1000003 Rev B Figure 3 Label 3 Identification MLS3080001 Rev F Figure...

Страница 26: ...se3 Figure 5 Label 5 Follow instructions for use MLS1000005 Rev C Figure 6 Label 6 High voltage caution MLS1000006 Rev B Figure 7 Label 7 Line voltage danger MLS1000007 Rev B Figure 8 Label 8 Foot ped...

Страница 27: ...7 IceSense3 MLS1000010 Figure 10 Label 10 Single use probe MLP7000001 Rev F Figure Label 11 Single use temperature sensor MLT8000001 Rev C Figure 11 Label 11 Single use temperature sensor MLT8000001 R...

Страница 28: ...rev L Confidential User Manual 28 IceSense3 Figure 13 Label 13 Cold area MLS1000010 Rev B Figure 14 Label 14 Empty LN2 Dewars MLS1000012 Rev A Figure 15 Label 15 Applied parts MLS1000014 Rev A Figure...

Страница 29: ...irements and standards are found on the IceSense3 cryoablation system These symbols are listed in the table below Table 1 1 International Symbols on IceSense3 cryoablation system Symbol Meaning Cautio...

Страница 30: ...ipal 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 whic...

Страница 31: ...p Authorized representative in the European community CE mark mandatory conformity mark for products placed on the market in the European Economic Area Transportation and storage atmospheric pressure...

Страница 32: ...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 e...

Страница 33: ...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...

Страница 34: ...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 flexi...

Страница 35: ...oprobe is connected to the cryohandle The cryohandle allows for maneuvering of the cryoprobe within the target tissue Figure 21 The flexible hose cryohandle and connected cryoprobe 1 Flexible hose 2 C...

Страница 36: ...ile 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 locate...

Страница 37: ...ature 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 tissu...

Страница 38: ...ature 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 2...

Страница 39: ...riate 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...

Страница 40: ...rules regarding the maintenance and handling of liquid nitrogen Dewars should always be observed Maintenance of liquid nitrogen should be performed by authorized personnel only Care must be taken when...

Страница 41: ...ad Figure 29 The Main Menu screen 3 4 2 System pre tests As the system uploads several internal built in tests are performed automatically in order to verify that the system is safe for use Additional...

Страница 42: ...tic 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 solu...

Страница 43: ...uid 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 b...

Страница 44: ...components The IceSense3 cryoablation system is packed and shipped in separate units as follows Main system User manual Two empty Dewars Accessories Foot pedal Not available in some regions e g China...

Страница 45: ...ures 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 t...

Страница 46: ...ay 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 docum...

Страница 47: ...n 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 Figure 31 The sys...

Страница 48: ...the options Light status indicator This is a BLUE LED which lights up around the Action button indicating the activity of a freeze cycle Active warm button this is a red button on the cryohandle It ac...

Страница 49: ...s The system general settings and technician mode is available by choosing the Settings button on left lower corner of the touch screen Fig 35 Figure 36 Activating the Settings option from the Main Me...

Страница 50: ...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 Figure...

Страница 51: ...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 Figure 39 The Windows Date and Time Properties screen Set the dat...

Страница 52: ...ow on Main Menu screen 5 2 7 1 Dewar Prepare the Dewar for treatment as per the following instructions and as detailed on the system screen see Fig 40 Filling the Dewar Open the Dewar compartment door...

Страница 53: ...damaged if after filling it frost appears on the outer wall of the container Return the Dewar to IceCure technician or an authorized distributor for inspection Warning Do not transfer a Dewar with Li...

Страница 54: ...2 1 4 cm Cryoprobe S 3 00 min 1 00 min 1 00 min 1 00 min 1 5 2 0 cm Cryoprobe S 4 30 min 1 30 min 1 30 min 1 30 min 2 1 2 5 cm Cryoprobe S L 6 00 min 2 00 min 2 00 min 2 00 min 2 6 3 0 cm Cryoprobe L...

Страница 55: ...r 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 Figure 44 Cryoprobe registration screen Caution Verify cryoprobe S N...

Страница 56: ...een to confirm that probe is in place Remove the probe cover that protects the tip When done press the Action button on the handle or Next on the touch screen Figure 45 Cryoprobe connection screen War...

Страница 57: ...ent please work sterilely Cover the touch screen and flexible hose with the suitable single use sleeves and the cryoprobe holder with a single use cover to ensure sterility 5 2 7 7 System test Perform...

Страница 58: ...safely from the cryohandle You will then be returned to the Main Menu screen Contact IceCure Medical technical service After successful internal test the system will display the visual inspection scr...

Страница 59: ...IceCure Medical If a functional problem occurs as represented by one of the pictures press on the relevant picture Follow system instructions until you are required to safely remove the probe from the...

Страница 60: ...s you to choose between Manual mode and Automatic mode using preset protocols To choose Automatic mode select one of the preset protocols from the Treatment Selection screen as shown below Type of tre...

Страница 61: ...ing 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 p...

Страница 62: ...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 Figure 51 Steps for adding a protocol 5 2 7 11...

Страница 63: ...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 s...

Страница 64: ...f 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 Confirm long...

Страница 65: ...y 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 Cyc...

Страница 66: ...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 Figure 55 Pause and Play buttons during the...

Страница 67: ...eatment screen for manual mode as show in Fig 54 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 w...

Страница 68: ...ion button on the cryohandle Figure 58 Thaw screen in Manual Mode You can continue to move between cycles by the same method To end the procedure press the Warm button on the cryohandle or the Warm ic...

Страница 69: ...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 cryo...

Страница 70: ...e system provides information regarding treatment progress The left side of the screen displays the Current Step freeze thaw or warm cycle and time left for this cycle The right side of the screen dis...

Страница 71: ...warm cycle is done for example 40 50 seconds for 2 cm iceball Wait for the message then gently remove the cryoprobe from the target tissue and then press Finish Do not force removal of the cryoprobe f...

Страница 72: ...the counter analgesics for mild discomfort after procedure o That swelling and moderate ecchymosis may be present for several weeks Warning DO NOT push the warm button when the cryoprobe is not withi...

Страница 73: ...ll Dewar in case you consider you may need an additional Dewar for a longer freeze time At every Thaw the system will automatically ask if you want to replace the Dewar figure below Figure 60 Replace...

Страница 74: ...eps then it will inform you that it is safe to replace the Dewar and you will get the Replace Dewar screen figure 64 below Please enter a full Dewar instead of the old one and only then press OK to co...

Страница 75: ...t was entered The screen will show Proceeding please wait figure below Figure 63 The replacement done follow up screen When preparation of the new Dewar is complete the system will come back to the Th...

Страница 76: ...dical Ltd DSR3000000 rev L Confidential User Manual 76 IceSense3 Warning If you don t press skip after replacing Dewar the system will stay in Thaw mode Figure 64 Replacement was completed before the...

Страница 77: ...er the Thaw ended 5 3 8 1 Replace the Dewar during Freeze In case of low Nitrogen the system can t continue to Freeze So it will ask to refill the Dewar in Freeze cycle see fig below Figure 66 Replace...

Страница 78: ...ress cancel you will end the procedure see figure below Figure 67 procedure stopped due to Low Nitrogen 5 4 Post operational stages 5 4 1 Removing the temperature sensor from tissue At the end of the...

Страница 79: ...et 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 app...

Страница 80: ...e3 cryoablation system treatment mode At the end of the treatment and after removing and disassembling the cryoprobe and temperature sensor return to the Main Menu screen by pressing the Main Menu ico...

Страница 81: ...er follow the system instructions Figure 73 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 tiss...

Страница 82: ...ain 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 electr...

Страница 83: ...IceCure Medical Ltd DSR3000000 rev L Confidential User Manual 83 IceSense3 To release the Emergency Stop button turn it clockwise...

Страница 84: ...Cure 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 r...

Страница 85: ...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 conne...

Страница 86: ...r 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 treatme...

Страница 87: ...own 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 repor...

Страница 88: ...urations are not available in some regions For example Probe name Length shaft tip Diameter Tip Cryoprobe L 140 mm 3 4 mm Trocar Cryoprobe S 126 mm 3 4 mm Trocar Cryoprobe 200S 168 mm 3 4 mm Pencil ty...

Страница 89: ...c 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 availabl...

Страница 90: ...n 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 vis...

Страница 91: ...edical 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 Medic...

Страница 92: ...n Check that the power cable is connected to the inlet and the wall outlet Check that main switch is ON Check that Emergency button is released If still there is no power contact IceCure Medical servi...

Страница 93: ...ssage still appears change cryoprobe If the problem persists contact IceCure Medical service Freeze Warm icon does not initiate the operation Faulty icon or operator misuse Try pushing the icon again...

Страница 94: ...to remove the cryoprobe Excess pressure on the pipes main valve open procedure not completed or Dewar relief valve malfunction When initial leak is detected screw the cryoprobe back in place Make sure...

Страница 95: ...es that the shaft is not frozen and that a small ice ball is created at the tip of the probe 9 If the test was successful press Success If not start over with a new sterile probe if required Procedure...

Страница 96: ...ryogen Liquid Nitrogen Boiling point 196 C Type of cryometer thermocouple type K Environmental conditions Temperatures Operating 10 C 40 C 50 F 104 F Transportation and Storage 0 C 70 C 32 F 158 F Rel...

Страница 97: ...0 C 3 The temperature of the homogenous medium is 37 C T medium 37 C 4 A visible ice ball is created at the 0 C isotherm 5 Exponential temperature distribution according to T x T medium T medium T cf...

Страница 98: ...ed 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 up...

Страница 99: ...Position __________________ Address Phone _____________________ Fax ___________________ Product Name Batch No Serial No Description of complaint Initial consequences Service No Harm Injury Death If d...

Страница 100: ...ecuresupport icecure medical com Toll free 888 516 7389 Tel 901 316 5672 Fax 901 316 5944 OR IceCure Medical Ltd HaEshel 7 2nd floor Southern Industrial Park Caesarea 38900 Israel info icecure medical...

Страница 101: ...t specified below The customer or the user of the model IceSense3 Cryotherapy product should assure that it is used in such an environment 3 Emissions test Compliance Electromagnetic environment guida...

Страница 102: ...vironment Surge EN 61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage...

Страница 103: ...ded 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 In...

Страница 104: ...ers and the model IceSense3 Cryotherapy product as recommended below according to the maximum output power of the communications equipment Rated maximum output of transmitter W Separation distance acc...

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