Opsens OptoMonitor 3 Instructions For Use Manual
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Opsens OptoMonitor 3 Instructions For Use Manual

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OptoMonitor 3
REF F2300 series System
Instructions for Use
en: Instructions for Use

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

  • Page 2: Table Of Contents

    Canada ........................... 20 Japan ..........................21 Essential performance ....................... 21 Deviation from the standards..................... 21 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 Transducer Interface Cable) ...............
  • Page 3 Playback Mode Functions ......................33 Universal Menu Functions ....................35 Archive Menu functions ....................37 OPTOMONITOR 3 INSTALLATION ....................38 Unpacking the OptoMonitor 3 System ..................39 Mountings the devices ....................... 39 Mounting the devices ..................... 39 Mounting the Optical Unit ....................39 Mounting the Display Unit ....................
  • Page 4 Using Aortic Input from Cathlab Hemodynamic System ..........57 Using Aortic Input from the Aortic Transducer (Use with BP-22 compatible transducer) . 58 Connect the OptoWire Cable FOIC Connector to the OptoMonitor 3 Handle Unit ...... 58 Zeroing OptoWire to Atmosphere ....................59 Automatic Zero.......................
  • Page 5 12 SPECIFICATIONS ..........................94 Technical Specifications ......................94 13 ORDERING INFORMATION ......................95 14 OPTOMONITOR 3 SYSTEM LOG – DISTAL INPUT VALUE ..............96 15 Appendix A: OptoMonitor 3 Installation Instructions ..............97 P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 6 16 Parameters ..........................101 17 AUX 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 Calibration ......................103 21 Installation Acknowledgement .....................
  • Page 7 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,...

  • Page 8: Introduction

    Carefully read and review this entire manual to fully understand the device, its operation, and the potential risks to user and patient before use of the OptoMonitor 3 System. Illustrations shown in this manual are intended to familiarize the user with the device. All illustrations in this manual serve as examples only.

  • Page 9: Indications For Use

    OpSens only. • Do not use 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 faulty readings may appear. In the event of system damage, turn the system off;...

  • Page 10: Cautions

    OptoMonitor 3 comply with the relevant EMC requirements. • Before connecting the equipment to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the OptoMonitor 3 label or in this manual. •...

  • Page 11: Precautions

    • Ensure OptoMonitor 3 is within operating temperatures (15 – 30°C / 59 - 86°F) prior to the procedure. If OptoMonitor 3 is outside of its normal operating temperatures, it may not function normally. • Connection to IT-NEWORKS including other equipment could result in previously unidentified risk to patients, operator or third parties.

  • Page 12: Storage And Handling

    Components should not be used if they have been subjected to temperatures exceeding safe storage and handling ranges. Do not use OptoMonitor 3 components if it was dropped onto a hard surface from higher than 12 inches (30.0 cm), because the system may be damaged and fail to operate properly.

  • Page 13: Symbols

    Symbols The symbols below may be found in these operating instructions or on the OptoMonitor 3 system, its accessories, packaging or training tools. Complies with the essential requirements of the relevant EU legislation applicable to 2797 the product Caution: Applicable laws restrict this device to sale by or on the order of a licensed healthcare practitioner.

  • Page 14: Cybersecurity

    Indicates equipment which emits 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 regulations concerning data privacy, security and confidentiality.
  • Page 15 Access codes and passwords are activated by default. Disabling them is accepting that • unauthorized access can be granted Hospital network should be protected using a firewall and an up-to-date antivirus software tool. • 15 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 16: Compliance With Regulatory Requirements

    2 COMPLIANCE WITH REGULATORY REQUIREMENTS Compliance with Standards and Directives OptoMonitor 3 complies with the applicable portions of the following standards: Council directive 93/42/EEC (Medical Device Directive). CSA Standards: CAN/CSA-C22.2 No. 60601- CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part...
  • Page 17 (FHSs) and License-Exempt Local Area Network (LE-LAN) Devices Manufacturer's declaration - Electromagnetic emissions The OptoMonitor 3 is intended for use in the electromagnetic environment specified below. The customer or the user of OptoMonitor 3 should ensure that it is in such an environment. Emission test Compliance level...
  • Page 18 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 environment specified below. The customer or the user of OptoMonitor 3 should ensure that it is in such an environment. Immunity test Basic EMC...
  • Page 19 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the OptoMonitor 3 is used exceeds the applicable RF compliance level above, the OptoMonitor 3 should be observed to verify normal operation.

  • Page 20: Rf Compliance

    Recommended separation distances between portable and mobile RF communications equipment and OptoMonitor 3 The OptoMonitor 3 is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of OptoMonitor 3 can help prevent...

  • Page 21: Japan

    Conformity Certification under the Radio Law. 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 or degraded do to electromagnetic disturbance. Essential performance...

  • Page 22: Overview Of The Optomonitor 3 System

    3 OVERVIEW OF THE OPTOMONITOR 3 SYSTEM Item Description Item Description OptoMonitor 3 Optical Unit (OpM3-OU) Aortic Transducer OpM3-OU Power cord & External Power AO Transducer Interface Cable (Aortic In) Supply OU-DU Communication Cable (Or Wireless Pressure Output Interface Cable (Aortic Out)

  • Page 23: Optomonitor 3 Optical Unit (Opm3-Ou)

    The OptoMonitor 3 is supplied with a power supply cord having three conductors; the earth conductor is only a functional earth. The OptoMonitor 3 Optical Unit supports both wired and wireless connection to its Display Unit. The wired connection is through an OU-DU communication cable if using the smaller 10” DU, or through a LAN wire if using the larger 15”...

  • Page 24: Aux In (Aux Interface Cable)

    Aortic In (AO Transducer Interface Cable) Mandatory unless using AUX Interface 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.

  • Page 25: Overview Of The Du

    Overview of the DU The OptoMonitor 3 Display Unit is the OptoMonitor 3 user interface. It displays the system status, performs pressure averaging, calculates FFR, dPR and displays relevant graphical curves and data. The DU also has built in speakers that alert the user in various ways (see section 3.6.1).

  • Page 26: Optomonitor 3 Handle Unit (Opm3-Hu)

    OptoMonitor 3 Handle Unit (OpM3-HU) The OptoMonitor 3 Handle Unit provides the link between the OptoWire pressure guidewire and the Optical Unit. The Handle Unit also has an LED on its front face that alerts the user in various ways (see section 3.6.2).

  • Page 27: Audio And Led Indicators

    Precautions to be taken in the event of changes to the performance of the transducer 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 are expressed in low, medium and high pitch tones. Audio Indicators...

  • Page 28: Color Indicators

    Color Indicators The LED indicator on the OptoMonitor 3 system will help you monitor the status of the system performances. 3.6.2.1 Optical Unit and Display Unit Indicators: The Optical Unit has six LED indicators on its front face, split into a top row of four LED’s and a bottom row of two LED’s.

  • Page 29: Graphical User Interface

    NOTE: Amber LED indications usually mean the system requires operator attention. Graphical User Interface OptoMonitor 3 Interface comprises a touch screen display with a graphical user interface through which all user interaction is performed. Measurements are displayed as real-time graphical curves as well as numerical values.
  • Page 30 MAIN SCREEN The first screen that appears when the instrument has been started is the MAIN screen. The MAIN screen is divided into five areas as shown below. 30 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 31 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 buttons. 31 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 32: Main Menu Screen Functions

    NOTE: It is required to create the patient ID before each case to associate recordings 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 more information.

  • Page 33: Playback Mode Functions

    FFR. The user can scroll through the recorded measurements to see changes of Pa and Pd over time. Pressing the FFR button in the data window will return the marker to the point of minimum FFR. FFR Button 33 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 34 Pd/Pa over time and be marked by a yellow line at the point of minimum Pd/Pa, as well as update the data window accordingly. Pressing the Pd/Pa button in the data window will return the marker to the point of minimum Pd/Pa. 34 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 35: Universal Menu Functions

    The recordings can also be browsed in the order they were recorded with the left and right arrow buttons. 2. Patient button 35 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 36 (pinch in). The zoom out is possible until the entire length of the recorded graph is in view. 10. dPR scale Press the dPR scale while in viewing a dPR Pullback in playback mode to manually change the selected scale. 36 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 37: Archive Menu Functions

    DICOM. Press this button to send a screen capture and data of the case recordings to the PACS. See section 7.10.4 for more information. 4. Storage Space button 37 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 38: Optomonitor 3 Installation

    OptoMonitor 3 Handle Unit (OpM3-HU) Pressure Output Interface Cable (Distal Gauge Factor Connector (Where Out) Applicable) AUX Interface Cable (AUX In) OptoWire Cable with FOIC Connector OptoWire Pressure Guidewire 38 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 39: Unpacking The Optomonitor 3 System

    1- Attach the clamp and adapter plate to the rear of the OptoMonitor 3 Display Unit with the supplied screws. 2- Affix OptoMonitor 3 Display Unit to a suitable place on an IV pole (not shown). Ensure that the mounting of OptoMonitor 3 Display Unit is secured and that its position is stable.

  • Page 40: Connecting The Handle Unit

    • Always reinstall the dust cap protector(s) on the optical connector(s). Dust entering the connector(s) may reduce the optical signal quality and generate “No optical signal” warning messages. 40 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 41: Connecting To Mains Supply

    Repeat the same process to connect the Display Unit to the main supply. Both OU and DU will automatically turn on once it is powered. Note that the same logic will apply during power losses. WARNING: Use only power supplies and power cords provided by OpSens. Connecting to Cathlab Hemodynamic High-Level Aortic Output The Optical Unit uses the signals from OptoWire and Aortic Pressure input to calculate both the dPR and FFR.

  • Page 42: Connecting Aortic Output To Cathlab Hemodynamic- Compulsory When Using The Ao Transducer Interface Cable

    > Pa Source and select AUX. Connecting Distal Output to Cathlab Hemodynamic- 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 transducer so that real-time Pd, Pd/Pa pressures can be shown on the Cathlab monitor.

  • Page 43: Connecting An External Screen

    DU-15 model). It may be connected to an external screen through one of these ports. The screen resolution of the DU-15” is 1024x768. First, connect the external screen and then boot the Display Unit. 43 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 44: Instrument Settings

    5 INSTRUMENT SETTINGS From the MAIN screen, tap the “Settings” button to access the OptoMonitor 3 SETTINGS menu. Here you can select the pressure scale range, the time scale, the pullback time scale, colors for Pa, Pd, Pd/Pa, and dPR, adjust the DU audio level, adjust the OU audio level, adjust the screen brightness, enable or disable dPR functionality, enable or disable prospective equalization, set the averaging period for dPR, set the Pd delay and hide/display the patient information.

  • Page 45: Dpr Enabled

    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. 45 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 46: Hide Patient Info

    2- Select the scale between 0 to 200, 0 to 250, 0 to 150, 0 to 100, -50 to 300, or -100 to 200 when the dropdown menu appears. 46 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 47: Time Scale

    1- Press the Pullback time scale button to access the time scale adjustments. 2- Select the time scale between 30, 45, 60 or 75 seconds by screen view when the dropdown menu appears. 47 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 48: Pa, Pd, Pd/Pa, Dpr Curves Color Selection

    Select which option you wish to adjust (DU audio, OU audio, or DU screen brightness) and drag the scale left or right until you are satisfied with the adjustment. 48 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 49: Averaging Period

    • Choosing a low number of heartbeats makes the pressure averaging faster and more sensitive to pressure changes, desirable using a short hyperaemic plateau, but it may also result in an averaging overly sensitive to arrhythmia and pressure disturbances. Pd Delay 49 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 50 4- If delay was accidentally set too high, press the “minus” button once to decrease the Pd delay by 8 ms. 5- Repeat the process of increasing/decreasing Pd delay by 8 ms until Pa and Pd curves are perfectly in sync. 50 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 51: Input/Output Calibration With Cathlab Hemodynamic System, And Time/Date/Language Adjustments Via The Maintenance Menu

    2- Enter the maintenance access code and press the green √ to continue. Refer to section 8.11 for default values. 3- Select Input/Output Calibration 4- Input/Output Calibration screen will be shown: Refer to Sections 17, 18, 19 and 20 for step-by-step calibration procedures. 51 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 52: Adjusting Time, Date And Language

    Adjusting Time, Date and Language Time, Date and Language screen will be shown. Adjustments are detailed in section 8.2. 52 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 53: Patient Case Management

    “Smith, John”, Patient ID: 123456. Note that patient name and ID appears in the information window, and all recordings saved under this case “123456” appears in recordings selection box. 53 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 54: Opening A New Case From Dicom List

    You can upload any recordings via USB export. (see section 7.10.3 for more information). Opening a New Case from DICOM List If DICOM between OptoMonitor 3 and Cathlab is successfully connected, the user can upload patient information from a DICOM list.

  • Page 55: Refreshing The Dicom List

    Press the “New Case” button, which is the first button at the bottom of the screen. This ends the previous case and allows the user to begin inputting new patient information. Follow the steps outlined above (6.1) to begin a new case. 55 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 56: Performing An Ffr Or Dpr Procedure

    608 valid tracings from the CONTRAST study. OpSens has shown that the accuracy, specificity and sensitivity of dPR compared to iFR as a reference standard , with a cut-off value of 0.89 and using both CONTRAST and VERIFY 2 studies, are 97.1% [95.7%, 98.1% @95%CI], 95.9% [93.6%, 97.5% @95%CI] and 98.4 [96.6%, 99.3% @95%CI] respectively.

  • Page 57: Starting The System

    1. Press the POWER switch, located on the underside of the unit, towards the right side of the device. 2. A single medium tone will sound from the DU, and the OpSens logo will appear. Wait until the MAIN menu is displayed and fully loaded (approx. 10 seconds).

  • Page 58: Using Aortic Input From The Aortic Transducer (Use With Bp-22 Compatible Transducer)

    “Aortic zero failed, old value used”. NOTE: The BP-22 compatible transducer is not supplied with the OPM3 system. Connect the OptoWire Cable FOIC Connector to the OptoMonitor 3 Handle Unit 1. Leave the OptoWire in the tray 2.

  • Page 59: Zeroing Optowire To Atmosphere

    Automatic Zero Zero must be completed before inserting the pressure guidewire into the patient. 1- The OptoMonitor 3 system will attempt to perform an auto zero once all components and connections are in place. 2- The message “Zero in progress…” appears on the Message window and a green LED flashing for a few seconds on the Handle Unit.

  • Page 60: Equalization

    WARNING: The OptoMonitor 3 will not zero (either automatically or manually) should the • pressure reading vary, for example detecting pulsatile blood pressure inside a patient. Equalization Pressure equalization is done in two successive steps: 1) Pa/Pd equalization 2) dPR factor equalization.

  • Page 61: Performing An Ffr Procedure

    1- From the MAIN screen, press the FFR button on the Display Unit Screen to start recording 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 may not be the minimum FFR value due to artifacts.

  • Page 62: Performing A Dpr Procedure

    2- You can track the progress of the dPR recording by a progress bar located in the bottom portion of the information bar. NOTE: Progress bar will change color according to your settings. 3- The OptoMonitor 3 will automatically switch to playback mode when the recording is complete. See section 7.9.2 for more details on dPR playback screen.

  • Page 63: Performing A Dpr Pullback

    1- From the MAIN screen, press the “dPR Pullback” button to initiate a dPR pullback recording. 2- The OptoMonitor 3 requires approx. 2 seconds after pressing the dPR pullback button before pullback recording is ready. Wait until the message is “dPR ready, perform pullback”.

  • Page 64: Viewing Ffr, Dpr, And Pullback In Playback Mode

    =0 seconds. During this replay, the live value of FFR is displayed in the bottom of the information window. Press the “Stop” button at any time during the replay to end it and return to the playback screen. 64 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 65: Viewing Dpr In Playback Mode

    3- dPR is calculated using OpSens own algorithm during the diastolic period of the pressure wave (heart at rest).

  • Page 66: Viewing Dpr Pullback In Playback Mode

    8- Pressing the “Play” button will cause the recording to replay as if it was a live measurement, from time =0 seconds. During this replay, the live value of dPR is displayed in the bottom of the 66 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 67: Viewing Pd/Pa Pullback In Playback Mode

    Pa, Pd, and Pd/Pa are updated as the graph is manipulated while dPR is not shown. To return to dPR pullback playback mode, simply press the dPR button. 67 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 68: Playback Functions

    ID number, date of patient’s birth, date of procedure, accession number, the name of performing physician, and any description relevant to the procedure/study. The marked fields are required to begin a new case. 68 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 69 To confirm changes made to patient information, press the green arrow button at the bottom right corner of the screen. See section 6 for more information regarding management of patient data. 69 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 70: Segments

    Segments The OptoMonitor 3 system can store vital information regarding vessel segments of individual patients. This information can be updated at any point during the procedure and can be passed along in USB or DICOM exports. 1- Physiology assessment is automatically updated based on the type of recording performed.
  • Page 71 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 hand corner of the screen. 71 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 72: Reviewing Data

    7.10.4.2 Uploading Procedures Data via DICOM Export If the OptoMonitor 3 system is properly linked to the facility’s RIS and PACS, you can export procedures data via DICOM: 1- From the MAIN screen, press the “Patient” button to access patient information.

  • Page 73: Maintenance

    Qualified service personnel should perform the following regular maintenance every 12 months to ensure OptoMonitor 3 optimal performance. The OptoMonitor 3 has a Maintenance menu where service personnel can verify the system performance status and ensure the system functions according to the manufacturing specifications.

  • Page 74: Adjusting The Time, Date, And Language

    For information regarding specific keypad symbols, refer to section 7.10.1. To set the language, press the “Language” button, and select the desired language from the drop-down menu. 74 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 75: Input/Output Calibration With Cathlab Hemodynamic System

    Calibrating Aortic Input Reference to Aortic Transducer Aortic Transducer Input calibration is detailed in section 18. Calibrating Aortic Input Reference to Cathlab Hemodynamic System 75 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 76: Calibrating Distal Output To Cathlab Hemodynamic System

    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 Output calibration is detailed in section 19. 76 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 77: Calibrating Aortic Output To Cathlab System

    OptoWire (image below). This screen displays to OptoWire’s Serial Number, probe value in nanometers, plus the actual value in nanometers read by the Optical Unit and the difference between the two (Delta). 77 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 78 Trained hospital technicians should inspect and test all isolated connections and the system power supply. • The Opsens OptoMonitor has no user-serviceable parts. Please refer any servicing to authorised service personnel or to Opsens directly. Mano. (mmHg): Check and validate that the OptoMonitor manometer reads the correct value. Read the atmospheric pressure and compare it with the OptoMonitor manometer reading.

  • Page 79: Testing Dicom

    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 time filter is applied. • Schedules for today: Only procedures that are scheduled for today will be displayed. 79 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 80: Display Information On The Exported Images

    The device will now require a password to be entered in order to use it upon start up. If chosen, the device will also lock after a certain amount of time inactive, requiring a password upon restarting. 80 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 81: Changing The Maintenance Access Code

    To lower cyber-security risks, the IT-network should be confined to the healthcare facility (not connected to the Internet). The intended information flow is: PEMS – (MWL Request)--> RIS – (Patient List)--> PEMS – (Procedure Results)--> PACS 81 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 82: Du-15" Lan2 Connection To The Optical Unit

    USB ports, DU adapter must indicate present and OU adapter must be selected. The “Scan” button will display all compatible wireless devices that may be connected to the DU. The strength of the signal is displayed in brackets. 82 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 83 Main Screen. No bars: Connexion is unlikely. 1 bar: Connexion is weak. 2 bars: Connexion is good. 3 bars: Connexion is strong. 4 bars: Connexion is excellent. 83 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 84: 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 Unit and Display Unit firmware can be updated by using a USB key containing the required software files. Both the Optical Unit and Display Unit are updated one at a time.

  • Page 85: Adjustable Settings

    Adjustable settings The following table shows the various adjustable settings with their ranges and default values. SETTINGS MENU Setting Range Default 85 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 86: Maintenance Menu Input/Output Calibration

    Use locking password Enabled, Disabled Enabled Password alphabetical characters, Ops22 numerical, and symbols Lock After Never, 10 min, 30 min, 60 min Never Maintenance Access Code numerical 0750 86 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 87: Maintenance Menu Network And Communication

    Disabled 9 FIELD SERVICE INFORMATION To reduce the risk of electric shock, do not remove cover (or back). The OpSens OptoMonitor 3 has no user-serviceable parts. Please refer any servicing to authorized service personnel or to OpSens directly. 87 |...

  • Page 88: General Care And Cleaning

    • If you spill liquid on the system or accessories, or they are accidentally immersed in liquid, contact your service personnel, OpSens or OpSens authorised service personnel. Do not operate the equipment before it has been tested and approved for further use.

  • Page 89: Handle Unit

    Dust entering the connector(s) may reduce the optical signal quality and generate “No optical signal” warning messages. OptoWire – Optical connector (Male) Handle Unit – Optical connector (Female) 89 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 90: Leakage Current Measurement

    Make sure all cables connected to the OptoMonitor 3 are locked into place and do not pull out •...

  • Page 91: Disposal

    • Carefully inspect the equipment for physical damage to the case, the display screen, and the keypad. Do not use the OptoMonitor 3 if damage is determined. Refer damaged equipment to qualified service personnel. • Inspect all external connections for loose connectors or frayed cables. Have any damaged connectors or cables replaced by qualified service personnel.

  • Page 92: Troubleshooting

    No signal, check OptoWire connection The Display Unit prompts this message when the OptoWire is not connected to the FOIC or the proper optical connection is not established. NOTE: The OptoMonitor 3 audio alert plays two different tones for optical connection event. •...

  • Page 93: Aortic Input Zeroing Failed

    Should a discrepancy be detected by the system, the AMBER LEDs on the Handle Unit will start flashing. The OptoMonitor 3 audio alert sounds 3 Medium tones. A message "Gauge Factor Connector  OptoWire mismatch” is displayed on the Message Window.

  • Page 94: Specifications

    10 – 85% non-condensing Applied part OptoWire (not supplied) Type CF Aortic transducer (not supplied) Type CF *Includes the effect of both the OptoMonitor 3 and OpSens pressure guidewire 94 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 95: Ordering Information

    Pressure output cable (Cathlab dependant) F20130* AO transducer interface cable (Cathlab dependant) *Interface cables are dependent on the hemodynamic system used in your Cathlab; contact OpSens at 1.418.781.0333 or info@opsensmedical.com for the specific interface cables. 95 | P a g e...

  • Page 96: Optomonitor 3 System Log - Distal Input Value

    14 OPTOMONITOR 3 SYSTEM LOG – DISTAL INPUT VALUE Dear valued customer, The OptoMonitor 3 System log is used for recording the OptoMonitor 3 Distal Input value (diagnostic value) on the initial installation. We recommend that you fill out the log and keep it in a file for reference for your system maintenance.

  • Page 97: Appendix A: Optomonitor 3 Installation Instructions

    15 Appendix A: OptoMonitor 3 Installation Instructions The following instructions give explanations on how to install the HU, DU, OU and PSU on the bedrail. Please note that this is a suggested installation. Assembly 1 Step 1 Step 2 Step 3...
  • Page 98 Instructions Screw the plate to the C- Screw the metal plate to the Insert pole in the C-Clamp Clamp OU with 4 screws. and tighten the clamping handle 98 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 99 Screw the plate to the C- Screw the plate to the back Insert the pole in the C- Clamp of the screen Clamp and tighten the clamping handle 99 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 100 Step 3 Installing the OpM3 DU- 10” on the desk stand Instructions Attach the plate to the back Screw the plate to the base Final view of the screen. 100 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 101: Parameters

    6. In the “AUX In” box, ensure that “Reading (mmHg)” shows a value +/-1 from what is being shown on the Cathlab screen. (e.g., if Cathlab reads 196 mmHg, “OptoMonitor 3 shall read between 195mmHg and 197mmHg.) If it does not, adjust the gain values of “AUX In”...

  • Page 102: Pa Input Calibration Using Optomonitor 3 And Aortic Transducer

    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 input gain can be adjusted. 102 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...

  • Page 103: Pd Output Calibration

    19 Pd Output Calibration Pd output calibration is performed with the system connected in its final configuration i.e.: with OptoMonitor 3 Pd output connected to its dedicated hemodynamic input. Cable Connection 1. Pd output connected to dedicated Hemo input (e.g. BP2).

  • Page 104: Appendix B- Installation Checklists

    ☐ No Distal Output Reference calibration performed according to IFU? ☐ Yes ☐ No Aortic output Reference and calibration performed according to IFU? ☐ Yes ☐ No Signature: 104 | P a g e LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08...
  • Page 105 OpSens Inc., 750 Boulevard du Parc Technologique, Quebec QC G1P 4S3 Canada MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany Emergo Australia, 201 Sussex Street, Darling Park, Tower II, Level 20, Sydney NSW 2000, Australia ©2019-2021 OpSens, Inc. All rights reserved. Specifications are subject to change without notice. 2797 105 |...

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