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Opsens OptoMonitor 3 Instructions For Use Manual Download Page 22

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

 

 

 

22 

|

 

P a g e

 

3

 

OVERVIEW OF THE OPTOMONITOR 3 SYSTEM 

 

 

Item  Description 

Item  Description 

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 

Communication, depending on Setup) 

11 

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 supplied).

 

12 

HU Optical Connector  

5 

OpM3-DU Power Cord & External Power 

Supply 

13 

HU Electrical Connector  

6 

Cathlab Hemodynamic System 

14 

OptoMonitor 3 Handle Unit (OpM3-HU) 

7  

Pressure Output Interface Cable (Distal Out) 

15 

Gauge Factor Connector (Where Applicable) 

8 

AUX Interface Cable (AUX In) 

16 

OptoWire Cable with FOIC Connector 

 

 

17 

OptoWire Pressure Guidewire 

 

 

 

Summary of Contents for OptoMonitor 3

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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