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LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08

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DISCLAIMER OF WARRANTY

OpSens Inc. warrants that reasonable care has been used in the design and manufacture of this

instrument. System manufactured by OpSens is warranted to be free of defects in materials and workmanship

for a period of one year from the date of shipment.

This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or

implied, written or oral, by operation of law or otherwise, including, but not limited to, any implied warranties

as to the condition, quality, durability, performance, merchantability or fitness for a particular purpose.

OpSens Inc. has no control over the conditions under which this instrument is used. Handling, storage and

cleaning of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical

procedures, and other matters beyond OpSens' control directly affect the instrument and the results

obtained from its use. OpSens assumes no liability with respect to instruments reused, reprocessed or re-

sterilized.

OpSens’ obligation under this warranty is limited to the repair or replacement of this instrument. However,

OpSens may, at its sole discretion, replace any instrument that 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 this instrument. OpSens neither assumes, nor

authorizes any other person to assume for it, any other or additional liability or responsibility in connection

with this instrument; no person has authority to bind OpSens to any representation, warranty, or liability

except as set forth in this Disclaimer of Warranty. OpSens Inc. shall not be liable to any person or entity for

any medical expenses, any loss or injury to a party’s profits or goodwill or any direct, incidental,

consequential, special, punitive or exemplary damages caused by, arising from or related to any use, defect,

failure or malfunction of the instrument, whether a claim for such damages is based upon warranty, contract,

tort or otherwise.

The exclusions, disclaimers, and limitations set forth in this Disclaimer of Warranty are not intended to, and

shall not be construed as to, contravene mandatory provisions of any applicable law or regulation. If any part

of this Disclaimer of Warranty is held to be illegal or unenforceable by a court of competent jurisdiction, the

part shall be modified to be enforceable to the maximum extent possible. If the part cannot be modified,

then that part may be severed, and the other parts of this Disclaimer of Warranty shall remain in full force

and effect.

Содержание OptoMonitor 3

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

Страница 2: ...ance 21 Deviation from the standards 21 3 OVERVIEW OF THE OPTOMONITOR 3 SYSTEM 22 OptoMonitor 3 Optical Unit OpM3 OU 23 Cathlab Interface Cables 23 AUX In AUX Interface Cable 24 Aortic In AO Transduce...

Страница 3: ...to Cathlab Hemodynamic Optional 42 Connecting DICOM 42 Connecting an external screen 43 5 INSTRUMENT SETTINGS 44 dPR Mode 44 dPR Disabled 44 dPR Enabled 45 Prospective Equalization 45 Hide Patient In...

Страница 4: ...ck in Playback Mode 64 Viewing FFR in Playback Mode 64 Viewing dPR in Playback Mode 65 Viewing dPR Pullback in Playback Mode 66 Viewing Pd Pa Pullback in Playback Mode 67 Playback functions 68 Creatin...

Страница 5: ...twork and Communication 87 9 FIELD SERVICE INFORMATION 87 10 GENERAL CARE AND CLEANING 88 Cleaning 88 Optical Unit and Display Unit 88 Handle Unit 89 Optical Connectors 89 Leakage Current Measurement...

Страница 6: ...In Calibration Using the OptoMonitor 3 and Cathlab Hemodynamic System 101 18 Pa Input Calibration Using OptoMonitor 3 and Aortic Transducer 102 19 Pd Output Calibration 103 20 Aortic Output Calibratio...

Страница 7: ...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 th...

Страница 8: ...over the distal pressure analog output The OptoMonitor 3 consists of the following components 1 OptoMonitor 3 Optical Unit OpM3 OU REF F2310 2 OptoMonitor 3 Display Unit 10 OpM3 DU REF F2320 or OptoM...

Страница 9: ...se OptoMonitor 3 if it has been dropped or in another way exposed to mechanical or electrical damage or if liquids have penetrated the housing The user or patient may be exposed to electrical shock or...

Страница 10: ...t please contact OpSens or personnel authorized by OpSens Radio transmitting equipment cellular phones and strong emission sources such as high frequency surgical equipment are capable of interfering...

Страница 11: ...adequate protection to radio frequency communication services The user might need to take mitigation measures such as relocating or re orienting the equipment This device may use Bluetooth 2 1 EDR com...

Страница 12: ...t a qualified field service person and or OpSens authorized service person or OpSens for assistance Storage and Handling The OptoMonitor 3 is shipped non sterile and must not be sterilized Store syste...

Страница 13: ...se IPX0 rating Limited protection against ingress of water IPX2 rating Protected against vertically falling drops of water This marking indicates that this product should not be disposed with other ho...

Страница 14: ...radio frequency signal Indicates equipment not to be used in MRI scanner room Cybersecurity OpSens makes no representation of warranty that use of the OptoMonitor complies with applicable laws and reg...

Страница 15: ...ated in an access controlled environment Use of Locking password ref section 8 6 1 is recommended Locking delay should be aligned with local hospital password policies Access codes and passwords are a...

Страница 16: ...erformance IEC 60601 1 2005 A1 2012 MOD IEC60601 1 6 2010 A1 2013 Medical Electrical Equipment Part 1 6 General requirements for basic safety and essential performance Collateral standard Usability IE...

Страница 17: ...anufacturer s declaration Electromagnetic immunity The OptoMonitor 3 is intended for use in the electromagnetic environment specified below The customer or the user of OptoMonitor 3 should ensure that...

Страница 18: ...ition NOTE UT is the A C mains voltage prior to application of the test level Manufacturer s declaration Electromagnetic immunity The OptoMonitor 3 is intended for use in the electromagnetic environme...

Страница 19: ...being optic NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection...

Страница 20: ...installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communicati...

Страница 21: ...s for Aux Pa inputs and output Pd output and HU interface Noise or loss of functionality appearing during a patient defibrillation Risk of fire or loss of isolation induced by component failure and mi...

Страница 22: ...Pressure 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 sup...

Страница 23: ...Aortic Transducer 5 Interface cable for Pd output to the hemodynamic system 6 Interface cable for Pa output to the hemodynamic system The OptoMonitor 3 Optical Unit supports both wired and wireless c...

Страница 24: ...cable 3 2 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 A...

Страница 25: ...their size and availability of ports All functions explanations and any other statement regarding the OpM3 DU applies to both sizes of DU the systems operate identically The smaller DU device 10 scree...

Страница 26: ...e Please contact your representative for OptoWire purchase Please refer to OptoWire IFU for the following Disposal of unit after use As applicable the appropriate process for cleaning and packaging St...

Страница 27: ...nsducer as a result of ageing and environmental conditions Audio and LED Indicators The OptoMonitor 3 has LEDs and audio indicators to identify the system status and performances The audio indicators...

Страница 28: ...ndicator indicates that the OU and DU are wirelessly connected The first LED of the top row indicates status of electrical connection with the Handle Unit A steady Green indicator indicates that the e...

Страница 29: ...pulsing Slow pulsing every 2 3 seconds Slow flashing Steady on NOTE Amber LED indications usually mean the system requires operator attention Graphical User Interface OptoMonitor 3 Interface comprises...

Страница 30: ...on This page displays all information about the OpM3 The date and time set by the DU the DU module number the DU and OU serial number as well as the OU DU and HU installed software versions and the OU...

Страница 31: ...Information field status indicators averaging period patient name patient ID date and time 3 Data window Pa and Pd average pressures Pd Pa and in Playback mode the Pa and Pd average pressures FFR Pd...

Страница 32: ...to a specific patient 2 AO Zero button OptoMonitor 3 Aortic Zero See section 7 2 2 for more information 3 Equalization button Equalize OptoWire Pd pressure to Aortic Pa pressure See section 7 5 for mo...

Страница 33: ...s to navigate through the recordings in chronological order A smaller graphic window is also displayed to present the user an overview of the current recording and move through the recording when a zo...

Страница 34: ...point of minimum dPR in the graphical window No values for Pa Pd or 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 min...

Страница 35: ...ong all recordings of a current patient case If no case is open see section 6 all previous recordings made without an open case will appear in this window with the NoPatient ID Tapping this box then a...

Страница 36: ...recording the time of the playback will be displayed to the left of the full recording window 5 Archive button Press this button to view previous recordings Accessing previous recordings will close t...

Страница 37: ...nly been USB exported 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...

Страница 38: ...tion 1 OptoMonitor 3 Optical Unit OpM3 OU 9 Aortic Transducer 2 OpM3 OU Power cord External Power Supply 10 AO Transducer Interface Cable Aortic In 3 OU DU Communication Cable Or Wireless Communicatio...

Страница 39: ...if using wireless connection ensure there is no interference that would interrupt the signal between the OU and DU NOTE If replacing a OptoMonitor ensure power supply is replaced as well OptoMonitor p...

Страница 40: ...dle Unit is suitable for installation within patient environment The Handle Unit is the connection cable between the OptoWire pressure guidewire and the Optical Unit 1 Handle Unit connects to the Opti...

Страница 41: ...1 Connect the AUX interface cable green to the hemodynamic high level pressure output associated to the Aortic pressure 2 Connect the AUX interface cable to the green connector of the Optical Unit lab...

Страница 42: ...Optional The OptoMonitor 3 has the capability to feed the distal pressure signal coming from the OptoWire pressure guidewire to the Cathlab Hemodynamic System by emulating a BP 22 compatible transduc...

Страница 43: ...mation Please indicate the following information DICOM Server Local AE title Remote AE title on OpM3 DICOM Server AE host IP DICOM Server Local port DICOM Institution Name DICOM Server Remote AE title...

Страница 44: ...dPR set the Pd delay and hide display the patient information The user can also initiate an OW zero from this menu if required as well as perform maintenance on the device The Averaging Period is aut...

Страница 45: ...ed to perform the equalization Therefore equalization seems instant to the operator as there is no delay between the moment the operator presses on the equalization button and the moment the equalizat...

Страница 46: ...on is present on the MAIN screen When Hide Patient mode is enabled patient information is absent from the MAIN screen Pressure Scale 1 Press the pressure scale button to access the pressure scale adju...

Страница 47: ...e between 3 6 15 or 30 seconds by screen view when the dropdown menu appears Pullback Time Scale The pull back time scale allows to view the whole dPR pullback curve in the same view 1 Press the Pullb...

Страница 48: ...lect a color 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 ot...

Страница 49: ...his only applies to FFR recordings Pd Delay CAUTIONS An insensitive or overly sensitive averaging of pressure may result in an incorrect FFR dPR value Choosing a high number of heartbeats will make th...

Страница 50: ...oWire for Pd This lag can be corrected using the Pd Delay button 1 Press the plus button once to increase the Pd delay by 8 ms 2 Return to live feed check to see if Pa and Pd curves are more in sync 3...

Страница 51: ...To access the Maintenance menu begin by entering the SETTINGS menu 5 1 Press the Maintenance button This will take you to the Maintenance menu 2 Enter the maintenance access code and press the green t...

Страница 52: ...LBL 2008 41 v5 OptoMonitor 3 IFU_en Rev 2021 08 52 P a g e Adjusting Time Date and Language Time Date and Language screen will be shown Adjustments are detailed in section 8 2...

Страница 53: ...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 Press the green arrow in the b...

Страница 54: ...om 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 the list Tap the desired patient data a...

Страница 55: ...ed 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 then the latest retrieve...

Страница 56: ...as also assessed in OpSens test report REP 2011 07 It was demonstrated that the diagnostic performance of dPR vs FFR is not statistically different from the diagnostic performance of iFR vs FFR with 9...

Страница 57: ...cock valve and ensure hemodynamic system aortic pressure Pa is properly zeroed 3 The guiding catheter should be frequently flushed with normal saline to ensure an optimal aortic pressure waveform with...

Страница 58: ...zeroed once and a zero value is stored in the memory the message Aortic zero failed old value used NOTE The BP 22 compatible transducer is not supplied with the OPM3 system Connect the OptoWire Cable...

Страница 59: ...y with standard saline solutions remove OptoWire from the tray The OptoWire pressure guidewire is ready to be used Manual Zero In some rare cases the OptoWire may need to be zeroed manually by the use...

Страница 60: ...to Equalization successful if equalization has been performed properly otherwise it will show Equalization failed and this step will have to be repeated 4 When equalization is completed the icon appea...

Страница 61: ...pressure The OptoMonitor 3 can record sequences over a total recording period of 2 hours 2 The minimum Pd Pa tracking automatically starts when the FFR button is pressed NOTE The minimum Pd Pa value m...

Страница 62: ...rocedure dPR Calculation 1 From the MAIN screen press the dPR button to trigger a dPR recording 2 You can track the progress of the dPR recording by a progress bar located in the bottom portion of the...

Страница 63: ...k During the pullback recording the time scale will adapt to the Pullback Time s set in the Settings Window and current dPR value will be displayed in the bottom of the data window 3 During the record...

Страница 64: ...imum 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 the graphical window Live values of...

Страница 65: ...ocally stored recordings for the current patient will appear in the recording selection box If no case is open all non case recordings will appear in the selection box The user can use their finger to...

Страница 66: ...ngs will appear in the selection box The user can use their finger to scroll up down to view all locally stored recordings and can tap a desired recording to load it into the graphical window and data...

Страница 67: ...ts resume and another recording can be initiated 11 Press the Pd Pa button to view the Pd Pa pullback recording see section 7 9 4 12 Pressing the dPR scale will override automatic scalling and scroll...

Страница 68: ...tap it once to load the data 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 the user to view...

Страница 69: ...anguage Select the desired language from the dropdown menu that appears 7 Press the backspace in the top right of the keypad to delete the symbol to the left of the cursor 8 Press the enter in the sec...

Страница 70: ...long in USB or DICOM exports 1 Physiology assessment is automatically updated based on the type of recording performed 2 The user can identify what step of the procedure this recording is related to e...

Страница 71: ...3 IFU_en Rev 2021 08 71 P a g e 4 The user can identify which drug was administered during the procedure 5 To confirm changes to the vessel segment information tap the green arrow in the bottom right...

Страница 72: ...tion filling the required fields to begin a case Press the green arrow in the bottom right hand portion of the screen to return to the MAIN screen 3 Perform one or multiple FFR dPR or dPR Pullback rec...

Страница 73: ...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 settin...

Страница 74: ...of the screen Note that this clock operates as a 24 hour clock To set the date press the date text box This will cause a numerical pad to appear at the bottom of the screen In the format of year month...

Страница 75: ...c System From the maintenance screen press the Input Output Calibration button located in the middle top portion of the grid Calibrating Aortic Input Reference to Aortic Transducer Aortic Transducer I...

Страница 76: ...08 76 P a g e Step by step AUX In Aortic input from Cathlab Hemodynamic System calibration is detailed in section 17 8 3 3 Calibrating Distal Output to Cathlab Hemodynamic System Step by step Distal...

Страница 77: ...rmance of the OptoWire currently being used If no wire is plugged into the OpM3 if the OptoWire is malfunctioning or if the OptoWire is not correctly plugged into the OpM3 then no data will appear on...

Страница 78: ...delta nm This value should not be less than 8 nanometers Diagnostic value Parameter Descriptions Typical signal with Reference Probe Poor signal Lamp Level Lamp driving level 70 Contrast Optical signa...

Страница 79: ...the Modality Worklist If no information is entered in the Schedules Stations Name and No specific window in the Query Window then all procedures from the Modality Worklist will be displayed in a limit...

Страница 80: ...ed in the center of the grid Setting up a Startup Password 1 If no startup password was previously required tap the box so that it is now required 2 Tap the Password textbox to bring up a keypad If a...

Страница 81: ...eviewing Network and Communication From the maintenance screen press the Network and Communication button located in the bottom left portion of the grid This screen displays the MAC addresses IP addre...

Страница 82: ...rial for DU 10 Once the connexion is established with the communication cable the following settings will allow a wireless connection DU adapter indicates if the wireless dongle is detected or not Not...

Страница 83: ...15 or Serial for DU 10 may be removed At least 2 out of 4 bars must be green for the signal to be acceptable OU DU Communication Link is Wireless and DU adapter is detected but wireless connexion is u...

Страница 84: ...ector NOTE May require removal of the protective panel along the bottom of the device to gain access to the USB port 2 On the DU screen press the SETTINGS button 3 Press the MAINTENANCE button 4 Enter...

Страница 85: ...ve may be removed If the dumping failed a pop up window will appear with an error message The message can be Make sure the OU is connected The OU and DU must be connected in order to dump the OU logs...

Страница 86: ...Source Transducer AUX AUX Aortic Transducer Input Gain 0 5 2 0 1 0 Aortic Transducer Output Output 0 50 100 200 300 30 Normal 0 100 0 200 0 300 30 300 Normal Aortic Transducer Output Gain 0 5 2 0 1 0...

Страница 87: ...lue MAC address for OU LAN LAN2 Address IP address format 192 168 0 100 LAN2 Net Mask xxx xxx xxx x 255 255 255 0 LAN2 Gateway xxx xxx xxx x blank OU adapter Enabled Disabled Disabled OU DU Communicat...

Страница 88: ...eaning the screen of the monitor because it is more sensitive to rough cleaning methods than the housing Do not allow water or cleaning solution to enter the measurement connectors Wipe around not ove...

Страница 89: ...a dedicated fiber optic cleaner tool The Handle Unit s optical connector female should be cleaned before every new connection of a OptoWire pressure guide wire Both the Handle Unit s optical connecto...

Страница 90: ...g is present that there are no spilled liquids and that there are no signs of abuse Make sure all cables connected to the OptoMonitor 3 are locked into place and do not pull out without releasing the...

Страница 91: ...aged connectors or cables replaced by qualified service personnel Inspect the Display Unit screen for marks scratches or other damage Have the Display Unit repaired by qualified service personnel Safe...

Страница 92: ...ptoWire pressure guidewire into its handle and rotate the locking mechanism to the locked position OptoWire Zeroing Failed The zero cannot be performed if pressure is varying such as pulsatile blood p...

Страница 93: ...l Equalization will not be performed when there is no Pa and or Pd signal Re Equalized Equalization is normally performed only once at the beginning of the FFR or dPR assessment Should a new equalizat...

Страница 94: ...pply DU supply DU 10 and DU 15 Classification Class II with functional ground Class I Isolation level 2xMOPP 2xMOPP Operating voltage 100 240 V 50 60 Hz 100 240 V 50 60 Hz Rated current AC 0 6 A 1 4 A...

Страница 95: ...F201014 AC Power cord C13 to P5 15P hospital grade 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 Ha...

Страница 96: ...ance 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 20...

Страница 97: ...U 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 post...

Страница 98: ...he 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 the C...

Страница 99: ...lamping 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 Clamp c...

Страница 100: ...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 catheterizati...

Страница 101: ...s 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 Reading mmHg in the AUX In box shows 0 0 If it does not adjust the offset va...

Страница 102: ...r 3 IFU_en Rev 2021 08 102 P a g e 7 Calibration complete Record any Offset Gain values in Appendix B 18 Pa Input Calibration Using OptoMonitor 3 and Aortic Transducer As required Aortic Transducer in...

Страница 103: ...reen Press the Input Output Calibration button in the middle of the top row of the screen Ensure Pa Source is set to Transducer 2 NOTE Changes to the Pa output Offset are avoided in an effort to not a...

Страница 104: ...nts 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 Reference...

Страница 105: ...word mark and logos are registered trademarks owned by Bluetooth SIG Inc and any use of such marks by licensee name is under license Other trademarks and trade names are those of their respective owne...

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