Opsens F2300 Series Instructions For Use Manual Download Page 89

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LBL-2019-41-v4 OptoMonitor 3 IFU wTAVI_en Rev 2022-03

P a g e

7.11

Terminate Operation

Once procedure is completed, unit can be left turned on. Optional screen lock will activate after specified

delay. It is possible to turn unit OFF by pressing the power button on the Optical Unit for approximately 5

consecutive seconds. The Display Unit can be turned off using the power button located under the unit.

Summary of Contents for F2300 Series

Page 1: ...OptoMonitor 3 REF F2300 series System Instructions for Use en Instructions for Use...

Page 2: ...3 Essential performance 20 2 4 Deviation from the standards 20 3 OVERVIEW OF THE OPTOMONITOR 3 SYSTEM 21 3 1 OptoMonitor 3 Optical Unit OpM3 OU 22 3 2 Cathlab Interface Cables 22 3 2 1 AUX In AUX Int...

Page 3: ...nnecting to Aortic Transducer Aortic Input 43 4 7 Connecting Aortic Output to Cathlab Hemodynamic compulsory when using the AO transducer interface cable 44 4 8 Connecting Distal Output to Cathlab Hem...

Page 4: ...the Aortic Transducer Use with BP 22 compatible transducer 64 7 3 Connect the FOIC Connector to the OptoMonitor 3 Handle Unit 65 7 4 Zeroing pressure guidewire to Atmosphere 66 7 4 1 Automatic Zero 6...

Page 5: ...ference to Aortic Transducer 92 8 3 2 Calibrating Aux Input Reference to Cathlab Hemodynamic System 92 8 3 3 Calibrating Distal Output to Cathlab Hemodynamic System 92 8 3 4 Calibrating Aortic Output...

Page 6: ...1 Verify the Connection of the pressure guidewire 107 11 2 Zeroing Failed 107 11 3 Wire Zeroed Twice 107 11 4 Aortic Input Zeroing Failed 108 11 5 Equalization Failed 108 11 6 Pressure Wire Delay mess...

Page 7: ...at is determined to have been out of specification at the time of shipment OpSens shall not be liable for any incidental or consequential loss damage or expense directly or indirectly from the use of...

Page 8: ...ft ventricular end of diastole pressure gradients regurgitation indices and optionally an ECG curve An analog output is provided to send distal pressure to the Cathlab Hemodynamic System An analog out...

Page 9: ...resence of flammable anesthetics mixture with oxygen or nitrous oxide vapors or liquids No modification of this equipment is allowed Do not open the OptoMonitor 3 housings All servicing and future upg...

Page 10: ...uring actual service life shall be evaluated based on the requirements of IEC 60601 1 1 3 2 Cautions To ensure patient safety use only parts and accessories specified in this manual At the end of its...

Page 11: ...tem should be located in a physically secure access controlled environment 1 3 4 Notes A warmup period approximately 20 minutes before the procedure is recommended Put the equipment in a location wher...

Page 12: ...rds and Directives o In case of a signal noise presumably caused by electromagnetic disturbances first verify the cabling and then move any portable RF communications equipment and mobile devices plac...

Page 13: ...em Follow instructions for use IPX0 rating Limited protection against ingress of water IPX2 rating Protected against vertically falling drops of water This marking indicates that this product should n...

Page 14: ...or storage condition and system use Atmospheric pressure range for storage condition Temperature range for storage condition Stacking limit This side up Fragile Handle with care Single use This symbol...

Page 15: ...n up to date antivirus software tool 2 COMPLIANCE WITH REGULATORY REQUIREMENTS 2 1 Compliance with Standards and Directives OptoMonitor 3 complies with the applicable portions of the following standar...

Page 16: ...Part 15 47 CFR 15 FCC 15 247 Systems Using Digital Modulation RSS 247 Digital Transmission Systems DTSs Frequency Hopping Systems FHSs and License Exempt Local Area Network LE LAN Devices Manufacture...

Page 17: ...5 1 kV with 0 90 180 270 differential mode 0 5 1 2 kV common mode IEC 60601 1 2 4th edition Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 0 5 cy...

Page 18: ...m 80 MHz to 2 7 GHz IEC 60601 1 2 4th edition 385MH z 27V m 450MHz 28V m 710MHz 9V m 745MHz 9V m 780MHz 9V m 810MHz 28V m 870MHz 28V m 930MHz 28V m 1720MHz 28V m 1845MHz 28V m 1970MHz 28V m 2450MHz 28...

Page 19: ...ations equipment Rated maximum output power of transmitter W Separation distance to frequency of transmitter m 150 kHz to 80 MHz d 1 17 P 80 MHz to 800 MHz d 1 17 P 800 MHz to 2 5 GHz d 2 33 P 0 1 0 3...

Page 20: ...fication under the Radio Law 2 3 Essential performance Below is the list of essential performance of the OptoMonitor 3 and what degradation an operator can expect if the essential performance is lost...

Page 21: ...ressure Output Interface Cable Aortic Out 4 OptoMonitor 3 Display Unit OpM3 DU Two accessible output USB connector for port powered USB key only not supplied video output for external monitor not supp...

Page 22: ...5 Interface cable for ECG input from the hemodynamic system 6 Interface cable for Pd output to the hemodynamic system 7 Interface cable for Pa output to the hemodynamic system The OptoMonitor 3 Optic...

Page 23: ...1 Provides Optical Unit with Pa readings directly from the Aortic Transducer making the OptoMonitor 3 a more independent device Cable model depends on your current Aortic Transducer system 3 2 3 Aort...

Page 24: ...ferent sizes small 10 and large 15 The only difference between the two units is their size and availability of ports All functions explanations and any other statement regarding the OpM3 DU applies to...

Page 25: ...red to calculate both the dPR and FFR This accessory is a single use Please contact your representative for OptoWire purchase Please refer to OptoWire IFU for the following Disposal of unit after use...

Page 26: ...Signal Impedance 3000 ohms 5 Minimum pressure range 30 to 300 mmHg Refer to the instructions for use provided by the Aortic Pressure Transducer manufacturer for the following Disposal of unit after u...

Page 27: ...function is not activated A flashing Blue indicator indicates that OU wireless is activated but not currently connected with a DU unit A steady Blue indicator indicates that the OU and DU are wireless...

Page 28: ...mber LED indicators provide information using color and flash coded sequences Please refer to table below for more details The flash coded sequences are represented graphically on the Handle unit as f...

Page 29: ...instrument INFORMATION SCREEN At start up of the device the application access code must be entered to access the MAIN screen Before accessing the Main Screen it is possible to access the System Info...

Page 30: ...hown 4 Message window Information and warning messages Once recording has started the elapsed time hh mm ss is displayed at the top left of the message windows 5 Menu window submenu s and function but...

Page 31: ...ortic Pa pressure See section 7 5 for more information 5 FFR button Begin recording a mean Pd mean Pa measurement When pressed it changes to a STOP FFR button pressing which will end the recording and...

Page 32: ...gender date of birth procedure date accession number performing physician name and study description From the patient information dialogue you can access the DICOM list See section 7 14 1 for more in...

Page 33: ...screen the user can use its fingers inside the main graphic window to manage the zoom by pinching and move through the recording by dragging Selecting a recording will cause the screen to show the rec...

Page 34: ...Pd Pa will be displayed in this playback mode Pressing the dPR button in the data window will return the marker to the point of minimum dPR Pressing the Pd Pa button in the information window while in...

Page 35: ...recording will display the recorded measurements in the graphical window The beats used to calculate measurements are selectable by a click on the data Measurements gradients and indices are displayed...

Page 36: ...ician and study description See section 7 10 1 for more information 4 Archive button Press this button to view previous recordings Accessing previous recordings will close the current case if open Thi...

Page 37: ...ressing which will end the playback and return to the playback screen As the system plays the recording the time of the playback will be displayed to the left of the full recording window 13 Averaging...

Page 38: ...orted or Anonymously exported PACS The patient folder has only been DICOM exported U P The patient folder has been USB exported or Anonymously exported and has also been DICOM exported 1 Back button P...

Page 39: ...mation about internal storage and external hardware device storage USB storage 6 Select All button Press this button to select or deselect all cases in the Archive Window 7 Delete button Press this bu...

Page 40: ...le Aortic Out 4 OptoMonitor 3 Display Unit OpM3 DU 12 HU Optical Connector 5 OpM3 DU Power Cord External Power Supply 13 HU Electrical Connector 6 Cathlab Hemodynamic System Supplied by others 14 Opto...

Page 41: ...the signal between the OU and DU NOTE If replacing a OptoMonitor ensure power supply is replaced as well OptoMonitor power supply is not authorized for use with the OpM3 4 2 3 Mounting the Display Uni...

Page 42: ...sts a wired connection may be required 4 3 Connecting the Handle Unit The Handle Unit is suitable for installation within patient environment The Handle Unit is the connection cable between the pressu...

Page 43: ...e aortic pressure Pa If using the Cathlab Hemodynamic System 1 Connect the AUX interface cable green to the hemodynamic high level pressure output associated to the Aortic pressure 2 Connect the AUX i...

Page 44: ...ansducer input of the Cathlab Hemodynamic System 2 Connect the Pressure output cable to the yellow port second from the left on the bottom row of ports on the Optical Unit labelled Aortic Out 3 From t...

Page 45: ...way to use DICOM Modality Worklist Server RIS information Please indicate the following information DICOM Server Local AE title Remote AE title on OpM3 DICOM Server AE host IP DICOM Server Local port...

Page 46: ...disable prospective equalization enable or disable dPR functionality set the averaging period for dPR set the pressure wire delay The user can also initiate an OW zero from this menu if required as w...

Page 47: ...e on your device 5 1 1 dPR Disabled When dPR mode is disabled dPR is not displayed as a value in the data window and the functions window loses its dPR and dPR pullback options 5 1 2 dPR Enabled When...

Page 48: ...tware has FFR dPR capabilities Check your activation key in Activation Management Menu to see what software features are available on your device This setting only applies to FFR dPR recordings Prospe...

Page 49: ...on Therefore equalization does not seem instant to the operator as there is a delay between the moment the operator presses on the equalization button and the moment the equalization is done 5 4 Hide...

Page 50: ...e auxiliary input can be connected to the Cathlab Hemodynamic system to receive an ECG signal Enabling the setting will show the received signal in live and playback 5 6 Pressure Scale 1 Press the pre...

Page 51: ...e scale between 3 mm s 6mm s 15mm s or 30mm s when the dropdown menu appears 5 8 Pullback Time Scale The pull back time scale allows to view the whole dPR pullback curve in the same view 1 Press the P...

Page 52: ...lor from the color pallet that appears Ensure each pressure curve calculation is your desired color To avoid confusion it is advised that each pressure curve calculation is unique from the others 5 10...

Page 53: ...IN screen indicates the selected Average Period setting NOTE This does not apply to dPR and dPR pullback recordings CAUTIONS An insensitive or overly sensitive averaging of pressure may result in an i...

Page 54: ...tem aortic transducer vs OpSens guidewire This lag can be corrected using the pressure wire Delay button 1 Press the plus button once to increase the wire delay by 8 ms 2 Return to live feed check to...

Page 55: ...ce Menu 5 13 1 Accessing the Maintenance Menu To access the Maintenance menu begin by entering the SETTINGS menu 0 1 Press the Maintenance button This will take you to the Maintenance menu 2 Enter the...

Page 56: ...Adjusting Time Date and Language Time Date and Language screen will be shown Adjustments are detailed in section 8 2 5 14 Activation Key The OpM3 requires an activation key to unlock the software s f...

Page 57: ...tick it on the back of the Display Unit Each activation key is unique to one Display Unit If new software functionalities are needed an activation card can be ordered from Opsens See section ORDERING...

Page 58: ...gs and recording is not available It is not possible to exit the settings screen The maintenance screen is available FFR dPR only Software is limited to use with FFR dPR capabilities FFR dPR TAVI TAVR...

Page 59: ...OTE Ensure that all information entered is correct in all relevant fields before moving onto next step Once a recording is made using a specified patient ID patient ID CANNOT be changed Exit the scree...

Page 60: ...hich is the second button along the bottom row of the screen Locate the desired patient in the DICOM list The list of patient data can be scrolled through by using the touch interface to swipe up down...

Page 61: ...he DICOM is disconnected a pop up window is displayed to inform the user that the DU failed to retrieve the DICOM list However if the DU was connected and then disconnected without rebooting the DU th...

Page 62: ...LBL 2019 41 v4 OptoMonitor 3 IFU wTAVI_en Rev 2022 03 62 P a g e Option 2 When viewing the patients recordings in the view screen press the Close Clase button...

Page 63: ...006 0106 std Coefficient of correlation R2 0 992 AUROC 0 9992 1 Levine et al 2011 ACF AHA SCAI PCI guideline for Percutaneous Coronary Intervention Journal American College of Cardiology 2011 58 44 12...

Page 64: ...2 2 As per standard procedure open aortic pressure transducer line to air by properly positioning stopcock valve and ensure hemodynamic system aortic pressure Pa Ao is properly zeroed 3 The guiding ca...

Page 65: ...ssage Aortic zero failed old value used NOTE The BP 22 compatible transducer is not supplied with the OPM3 system 7 3 Connect the FOIC Connector to the OptoMonitor 3 Handle Unit 1 Leave the pressure w...

Page 66: ...gn at the upper left corner of the MAIN screen confirms a successful pressure guidewire zero The third LED indicator on the top row of the Optical Unit will also flash green to indicate successful zer...

Page 67: ...ush the catheter with saline 2 Verify Pd is equal to Pa 3 Press the EQUALIZATION button to begin equalization of the Pd pressure guidewire and Pa aortic readings The message window will show the Equal...

Page 68: ...yWire is level with the heart 7 Press the EQUALIZATION button 8 The message window will show the Equalization in progress message After a short time the message will update to Equalization successful...

Page 69: ...t be the minimum FFR value due to artifacts When finished recording ensure to place the cursor on the minimum FFR value in playback mode by pressing the Pd Pa button 4 During recording tap the graphic...

Page 70: ...olor according to your settings 4 The OptoMonitor 3 will automatically switch to playback mode when the recording is complete See section 7 12 2 for more details on dPR playback screen 5 To make anoth...

Page 71: ...o create a marker solid white line 4 Press the Stop Pullback button to end the recording The screen will switch to playback mode See section 7 12 3 for more details of dPR pullback playback 5 To make...

Page 72: ...int of maximum hyperemia 4 The minimum FFR value calculated over the length of the recording is displayed in the data window under Pd Pa default yellow Minimum FFR is also marked by a yellow line in t...

Page 73: ...recording press the View button on the MAIN screen 2 All locally stored recordings for the current patient will appear in the recording selection box If no case is open all non case recordings will ap...

Page 74: ...o marked by a purple line in the graphical window The live dPR value is defined by the right axis of the graph 5 The user can use their finger to scroll the marker left right to view specific sections...

Page 75: ...ion of a SavvyWire pressure guidewire 2 For accurate measurements equalize the pressure guidewire with the aortic transducer The procedure is described in section 7 7 1 3 From the MAIN screen press th...

Page 76: ...playback mode where the user can see all the recorded data of the current patient If you wish to access playback mode without performing a recording press the View button from the MAIN screen All loc...

Page 77: ...ices Period 7 9 4 Select indices period In TAVI TAVR the number of beats used to calculate gradients regurgitation indices and LVEDP This will change the number of beats selected in playback The heart...

Page 78: ...t to the PACS The View screen shows the same information and capabilities but the layout is different The removal of the file selector allows more space to display the signal and the save and DICOM Ex...

Page 79: ...ssures Gradient Peak to peak This is the difference in pressure found between LV and Ao systolic values The indicator is in the middle between the LV and Ao peak position and the circles are located a...

Page 80: ...LBL 2019 41 v4 OptoMonitor 3 IFU wTAVI_en Rev 2022 03 80 P a g e Mean gradient and LVEDP positions are shown...

Page 81: ...ording and tap it once to load the data 7 10 1 Creating or Updating Patient Information 1 From the MAIN screen press the Patient button Pressing the Patient button from the play back screen will allow...

Page 82: ...the cursor 8 Press the enter in the second row along the right side of the keypad to enter the text into the field and remove the keypad 9 Press the keypad on the bottom row along the right side of th...

Page 83: ...ated to e g pre or post PCI 3 The user can identify the particular vessel this recording is related to The user can choose the vessel from the drop down list or alternatively select the corresponding...

Page 84: ...back button 7 10 3 TAVI TAVR Notes The OptoMonitor 3 system can store information alongside the recordings This information can be updated at any point during the procedure and can be passed along in...

Page 85: ...LBL 2019 41 v4 OptoMonitor 3 IFU wTAVI_en Rev 2022 03 85 P a g e 2 The user can identify the valve and valve size used during the procedure...

Page 86: ...IFU wTAVI_en Rev 2022 03 86 P a g e 3 Text notes can also be saved alongside the recordings 4 The button allows the creation of custom valve types and procedure steps These can be deleted by using the...

Page 87: ...sert a USB 3 0 drive into one of the USB ports along the bottom of the device NOTE You may need to unscrew the protective panel along the bottom of the device to insert the drive 2 From the Archive sc...

Page 88: ...recordings along with procedure specific data such as the FFR or dPR value The images are then sent via DICOM to the PACS and is now available for viewing storing in patient data in the PACS If a rec...

Page 89: ...re is completed unit can be left turned on Optional screen lock will activate after specified delay It is possible to turn unit OFF by pressing the power button on the Optical Unit for approximately 5...

Page 90: ...the system performance status and ensure the system functions according to the manufacturing specifications The Maintenance Menu gives access to the following parameters adjustments and factory setti...

Page 91: ...s the date text box This will cause a numerical pad to appear at the bottom of the screen In the format of year month day type in the corresponding numerical date By tapping on the text box you can se...

Page 92: ...er Input calibration is detailed in section 18 8 3 2 Calibrating Aux Input Reference to Cathlab Hemodynamic System Step by step AUX In Aortic input from Cathlab Hemodynamic System calibration is detai...

Page 93: ...correctly plugged into the OpM3 then no data will appear on this screen Once a functioning pressure wire is connected to the OpM3 system this screen will populate with live data relating to the perfo...

Page 94: ...regarding the connection between OpM3 and DICOM uplink Qualified personnel may use this screen to test the status of the OpM3 and DICOM connection Diagnostic value Parameter Descriptions Typical signa...

Page 95: ...eduled Station Name The Scheduled Station Name must be entered manually In the Query Window drop down menu it is possible to filter down the list by a time frame No specific Window In this case no tim...

Page 96: ...e to lock after a certain amount of inactivity tap the Lock After field and choose the desired time from the drop down menu 4 To save password lock changes exit the screen with the back button The dev...

Page 97: ...urpose is to query the patient list and transfer procedure results through DICOM The required characteristics of the IT network is to have an Ethernet LAN connectivity to an RIS and PACS server The co...

Page 98: ...nt indicates that the dongle is connected OU adapter allows user to deactivate the wireless module within the OU This must be selected for a successful wireless connection To insure a successful wirel...

Page 99: ...excellent 8 9 Software Update for Display Unit or Optical Unit From the maintenance screen press the Software Update button located in the bottom middle portion of the grid The OptoMonitor 3 Optical U...

Page 100: ...drive in the DU and navigate to the Maintenance window Press DUMP DU Log button to save DU logs to the USB drive Press DUMP OU Log button to save OU logs to the USB drive In both cases a text file wil...

Page 101: ...Prospective Equalization Enabled Disabled Disabled Averaging period 1 2 3 4 5 3 Pullback time scale 30 45 60 75 45 Hide Patient Info Enabled Disabled Disabled Pressure Wire Delay 0 504 0 Show ECG Ena...

Page 102: ...2 Net Mask xxx xxx xxx x 255 255 255 0 LAN2 Gateway xxx xxx xxx x blank OU adapter Enabled Disabled Disabled OU DU Communication link LAN Wireless Serial Wireless LAN DU 15 Serial DU 10 Wireless Enabl...

Page 103: ...not disconnect the Handle Unit cable from the Optical Unit 2 Place the dust cover on the opening of the Handle Unit 3 Lightly wipe the handle with gauze moistened with rubbing alcohol 70 isopropyl alc...

Page 104: ...pressure guidewire Both the Handle Unit s optical connector male and the Optical Units optical connector female should be cleaned before being connected during installation To keep the Handle Unit s...

Page 105: ...do not pull out without releasing the locking mechanism Inspect all accessories cables pressure guidewire and so forth If any signs of damage are observed do not use Inspect all cables and their stra...

Page 106: ...ice personnel Safety labels and inscription on the device are clearly legible 10 4 Disposal Pressure guidewire clock battery and electronic equipment shall be handled and disposed of in accordance wit...

Page 107: ...k the Handle locking mechanism and gently remove the pressure guidewire from its handle 2 Gently reinsert the pressure guidewire into its handle and rotate the locking mechanism to the locked position...

Page 108: ...ake sure both OU and DU are powered on Communication error with Optical Unit Please check Wireless Signal Strength or Physical Connection Equalization will not be performed because there is a poor or...

Page 109: ...To avoid an extra step after an eventual restart the equalization factor is NOT reset when the instrument is restarted The equalization parameters are kept in the non volatile memory of the Gauge Fac...

Page 110: ...ale 100 mmHg V Aortic pressure input scale 5 V V mmHg Electrical specifications OU supply DU supply DU 10 and DU 15 Classification Class II with functional ground Class I Isolation level 2xMOPP 2xMOPP...

Page 111: ...tor 3 IFU wTAVI_en Rev 2022 03 111 P a g e Applied part OptoWire not supplied SavvyWire not supplied Aortic transducer not supplied Type CF Type CF Includes the effect of both the OptoMonitor 3 and Op...

Page 112: ...e NA 10ft F201015 AC Power cord Israel SI 32 F2320 OPM3 DU Display Unit 10 F2321 OPM3 DU Display Unit 15 F2322 OPM3 DU Wireless dongle F2330 OPM3 HU Handle Unit F232009 OPM3 DU OU communication RS 232...

Page 113: ...tenance purpose Parameter Descriptions Typical signal with Reference Probe Poor signal Lamp Lamp driving level 70 Contrast Optical signal contrast visibility level 50 35 SNR Signal to noise ratio 4000...

Page 114: ...PSU on the bedrail Please note that this is a suggested installation Assembly 1 Step 1 Step 2 Step 3 Installing the Bedrail Post Clamp on the IV pole Instructions Insert the IV pole in the Bedrail po...

Page 115: ...n the OU DU 2ft pole Instructions Insert pole in the OpM3 HU Tighten the clamping handle Assembly 3 Step 1 Step 2 Step 3 Installing the OpM3 OU on the OU DU 2ft pole Instructions Screw the plate to th...

Page 116: ...he clamping handle Make sure the PSU mount for C Clamp is mounted with the cable passage towards the bottom This helps maintain the power cord and avoid accidental disconnection The PSU mout for C Cla...

Page 117: ...nd tighten the clamping handle The following instructions give explanations on how to install the DU on the desk stand in the case where the DU is being installed in the Control Room of the catheteriz...

Page 118: ...located in the middle of the top row of the screen Ensure Pa Source is set to Aux 2 In the Pd Out box click the Output mmHg drop down menu and select 0 3 Zero Cathlab BP1 channel 4 Ensure that Readin...

Page 119: ...g If it is not adjust the offset values in the Pd Out box until it does 5 Next in the Pd Out box set the Output mmHg to 200 6 Check that the Cathlab Pa measurement is within 1mmHg of 200mmHg If it is...

Page 120: ...the Aortic Transducer Output box set Output mmHg to 200 mmHg 4 Check the reading on the Cathlab Ensure that the Cathlab is showing 200mmHg 1mmHg If it is not adjust the Aortic Transducer Output gain u...

Page 121: ...ments settings verified Averaging Period Setting 3 Yes No Graph Pressure 0 to 150 or 0 to 200 Time scale 6 I O Final OFFSET adjustment value Final GAIN adjustment value Aortic Transducer Input Referen...

Page 122: ...toWire and SavvyWire are registered trademarks owned by OpSens Inc Other trademarks and trade names are those of their respective owners Manufactured By OpSens Inc 750 Boulevard du Parc Technologique...

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Summary of Contents for F2300 Series

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Opsens F2300 Series, Instructions For Use Manual, Page: 89 / 122

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Summary of Contents for F2300 Series

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