Opsens F2300 Series User manual

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

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1Contents
1. INTRODUCTION..................................................................................................................................... 8
1.1 Indications for Use ............................................................................................................................ 9
1.1.1 Intended user........................................................................................................................ 9
1.1.2 Intended environment.......................................................................................................... 9
1.2 Contraindications.............................................................................................................................. 9
1.3 Safety ................................................................................................................................................ 9
1.3.1 Warnings ............................................................................................................................... 9
1.3.2 Cautions .............................................................................................................................. 10
1.3.3 Precautions ......................................................................................................................... 11
1.3.4 Notes...................................................................................................................................11
1.4 Storage and Handling...................................................................................................................... 12
1.5 Symbols ........................................................................................................................................... 13
1.6 Cybersecurity .................................................................................................................................. 15
2 COMPLIANCE WITH REGULATORY REQUIREMENTS...........................................................................15
2.1 Compliance with Standards and Directives ....................................................................................15
2.2 RF Compliance................................................................................................................................. 19
2.2.1 United States....................................................................................................................... 19
2.2.2 Canada ................................................................................................................................ 20
2.2.3 Japan ................................................................................................................................... 20
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 Interface Cable)..............................................................................................23
3.2.2 Aortic In (AO Transducer Interface Cable) ..........................................................................23
3.2.3 Aortic Out Cable (Pressure Output Interface Cable)........................................................... 23
3.2.4 Distal Out (Pressure Output Interface Cable) .....................................................................23
3.3 OptoMonitor 3 Display Unit (OpM3-DU) ........................................................................................ 23
3.3.1 Overview of the DU............................................................................................................. 24
3.4 OptoMonitor 3 Handle Unit (OpM3-HU) ........................................................................................ 25
3.5 Accessories...................................................................................................................................... 25
3.5.1 OptoWire™ Pressure Guidewire (not supplied)..................................................................25
3.5.2 SavvyWire™ Pressure Guidewire (not supplied)................................................................. 25
3.5.3 Aortic transducer (supplied by others) ...............................................................................26
3.6 Audio and LED Indicators ................................................................................................................26
3.6.1 Audio Indicators .................................................................................................................. 26

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3.6.2 Color Indicators...................................................................................................................27
3.7 Graphical User Interface .................................................................................................................29
3.8 Coronary procedure main Menu Screen Functions........................................................................ 30
3.9 Structural procedure main Menu Screen Functions.......................................................................32
3.10 Playback Mode Functions ...............................................................................................................33
3.10.1 Universal Menu Functions ..................................................................................................35
3.10.2 Archive Menu Functions ..................................................................................................... 38
4 OPTOMONITOR 3 INSTALLATION........................................................................................................40
4.1 Unpacking the OptoMonitor 3 System ...........................................................................................40
4.2 Mounting the devices ..................................................................................................................... 41
4.2.1 Mounting the devices ......................................................................................................... 41
4.2.2 Mounting the Optical Unit ..................................................................................................41
4.2.3 Mounting the Display Unit .................................................................................................. 41
4.3 Connecting the Handle Unit............................................................................................................42
4.4 Connecting to Mains Supply ...........................................................................................................43
4.5 Connecting to Cathlab Hemodynamic High-Level Aortic Output ................................................... 43
4.6 Connecting 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 Hemodynamic- Optional...................................................... 44
4.9 Connecting DICOM..........................................................................................................................45
4.10 Connecting an external screen .......................................................................................................45
5 INSTRUMENT SETTINGS ......................................................................................................................46
5.1 dPR Mode........................................................................................................................................ 46
5.1.1 dPR Disabled ....................................................................................................................... 47
5.1.2 dPR Enabled ........................................................................................................................ 47
5.2 TAVI/TAVR Mode ............................................................................................................................ 48
5.3 Prospective Equalization................................................................................................................. 48
5.4 Hide Patient Info ............................................................................................................................. 49
5.5 Show ECG ........................................................................................................................................50
5.6 Pressure Scale ................................................................................................................................. 50
5.7 Time Scale ....................................................................................................................................... 51
5.8 Pullback Time Scale......................................................................................................................... 51
5.9 Color Selection ................................................................................................................................ 52
5.10 Audio and Brightness level.............................................................................................................. 52
5.11 Averaging period............................................................................................................................. 53
5.12 Pressure Wire Delay........................................................................................................................ 54
5.13 Input/Output Calibration with Cathlab Hemodynamic System, and Time/Date/Language
Adjustments via the Maintenance Menu ...............................................................................................55
5.13.1 Accessing the Maintenance Menu...................................................................................... 55
5.13.2 Adjusting Time, Date and Language ................................................................................... 56
5.14 Activation Key ................................................................................................................................. 56

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5.14.1 Activation card .................................................................................................................... 57
5.14.2 Activation Management menu ........................................................................................... 57
5.14.3 Activating the software.......................................................................................................58
5.14.4 Edit or remove the activation key....................................................................................... 58
6 PATIENT CASE MANAGEMENT............................................................................................................ 59
6.1 Opening a New Case ....................................................................................................................... 59
6.1.1 Opening a New Case Without DICOM ................................................................................59
6.1.2 Opening a New Case from DICOM List................................................................................60
6.1.3 Refreshing the DICOM list................................................................................................... 61
6.2 Ending an Open Case/ Starting a Second Case ............................................................................... 61
7 PERFORMING a PROCEDURE ..............................................................................................................63
7.1 Starting the System......................................................................................................................... 64
7.2 Verifying Optimal Aortic Pressure Waveform and ensuring Ao Zero ............................................. 64
7.2.1 Using Aortic Input from Cathlab Hemodynamic System ....................................................64
7.2.2 Using Aortic Input from 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 ...................................................................................................................66
7.4.2 Manual Zero........................................................................................................................66
7.5 Equalization..................................................................................................................................... 67
7.5.1 FFR/dPR procedure equalization ........................................................................................ 67
7.5.2 TAVI/TAVR procedure equalization .................................................................................... 68
7.6 Performing an FFR Procedure .........................................................................................................68
7.6.1 Inducing Maximum Hyperemia...........................................................................................68
7.6.2 Recording Pressure – FFR.................................................................................................... 68
7.7 Performing a dPR Procedure........................................................................................................... 70
7.7.1 dPR Calculation ................................................................................................................... 70
7.7.2 Performing a dPR Pullback.................................................................................................. 70
7.8 Viewing FFR, dPR, and Pullback in Playback Mode......................................................................... 72
7.8.1 Viewing FFR in Playback Mode ...........................................................................................72
7.8.2 Viewing dPR in Playback Mode........................................................................................... 73
7.8.3 Viewing dPR Pullback in Playback Mode............................................................................. 74
7.8.4 Viewing Pd/Pa Pullback in Playback Mode ......................................................................... 75
7.9 Performing TAVI/TAVR procedure .................................................................................................. 75
7.9.1 When to record................................................................................................................... 75
7.9.2 Recording Pressure – TAVI/TAVR........................................................................................ 75

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7.9.3 Viewing TAVI/TAVR in Playback Mode................................................................................ 76
7.9.4 Select indices period ...........................................................................................................77
7.9.5 Compare/View screen......................................................................................................... 78
7.9.6 Playback Gradients and regurgitation indicators................................................................ 78
7.10 Playback functions .......................................................................................................................... 81
7.10.1 Creating or Updating Patient Information.......................................................................... 81
7.10.2 FFR/dPR Notes ....................................................................................................................82
7.10.3 TAVI/TAVR Notes ................................................................................................................ 84
7.10.4 Reviewing Data ...................................................................................................................87
7.10.5 Archiving and deleting data ................................................................................................ 87
7.11 Terminate Operation ......................................................................................................................89
8 MAINTENANCE.................................................................................................................................... 90
8.1 Accessing the Maintenance Menu.................................................................................................. 90
8.2 Adjusting the Time, Date, and Language ........................................................................................ 91
8.3 Input/output Calibration with Cathlab Hemodynamic System ...................................................... 91
8.3.1 Calibrating Aortic Input Reference 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 to Cathlab System...................................................................... 93
8.4 Reviewing Optical Sensor Performance.......................................................................................... 93
8.5 Testing DICOM ................................................................................................................................94
8.5.1 Testing DICOM ....................................................................................................................95
8.5.2 Filtering the Modality Worklist ...........................................................................................95
8.5.3 Display information on the Exported Images ..................................................................... 95
8.6 Security ........................................................................................................................................... 95
8.6.1 Setting up a Startup Password ............................................................................................ 96
8.6.2 Changing the Maintenance Access Code ............................................................................96
8.7 Reviewing Message History ............................................................................................................97
8.8 Reviewing Network and Communication .......................................................................................97
8.8.1 DU LAN1 connection to DICOM .......................................................................................... 97
8.8.2 DU-15” LAN2 connection to the Optical unit...................................................................... 97
8.8.3 Wireless............................................................................................................................... 98
8.9 Software Update for Display Unit or Optical Unit .......................................................................... 99
8.10 Factory Settings.............................................................................................................................100
8.11 DUMP Logs....................................................................................................................................100
8.12 Adjustable settings........................................................................................................................ 101
8.12.1 SETTINGS MENU................................................................................................................ 101

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8.12.2 MAINTENANCE MENU Input/Output Calibration ............................................................. 101
8.12.3 MAINTENANCE MENU Security.........................................................................................101
8.12.4 MAINTENANCE MENU Network and Communication...................................................... 102
9 FIELD SERVICE INFORMATION .......................................................................................................... 102
10 GENERAL CARE AND CLEANING ........................................................................................................102
10.1 Cleaning.........................................................................................................................................102
10.1.1 Optical Unit and Display Unit............................................................................................103
10.1.2 Handle Unit .......................................................................................................................103
10.1.3 Optical Connectors............................................................................................................ 104
10.2 Leakage Current Measurement .................................................................................................... 105
10.3 Visual Inspection ........................................................................................................................... 105
10.3.1 General Routine Inspection .............................................................................................. 105
10.3.2 Annual Visual Inspection................................................................................................... 105
10.4 Disposal......................................................................................................................................... 106
11 TROUBLESHOOTING.......................................................................................................................... 107
11.1 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 messages .....................................................................................................108
11.7 Re-Equalized..................................................................................................................................109
11.8 GFC and OptoWire™ Mismatch .................................................................................................... 109
12 SPECIFICATIONS ................................................................................................................................ 110
12.1 Technical Specifications ................................................................................................................110
13 ORDERING INFORMATION ................................................................................................................112
14 OPTOMONITOR 3 SYSTEM LOG – DISTAL INPUT VALUE................................................................... 113
15 Appendix A: OptoMonitor 3 Installation Instructions ...................................................................... 114
16 Parameters........................................................................................................................................ 118
17 AUX In Calibration Using the OptoMonitor 3 and Cathlab Hemodynamic System .......................... 118
18 Pa Input Calibration Using OptoMonitor 3 and Aortic Transducer .................................................. 119
19 Pd Output Calibration ....................................................................................................................... 119
20 Aortic Output Calibration.................................................................................................................. 119
21 Installation Acknowledgement .........................................................................................................120
22 Appendix B- Installation Checklist..................................................................................................... 121

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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.

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1. INTRODUCTION
Product description
The OptoMonitor 3 – OptoWire™ pressure guidewire combination connected to a Cathlab
Hemodynamic System or aortic transducer, is intended to be used or supervised by cardiologists in
catheterization laboratories for intravascular blood pressure measurement such as the FFR and dPR
measurement.
The OptoMonitor 3 – SavvyWire™ pressure guidewire combination connected to a Cathlab
Hemodynamic System or aortic transducer, is intended to be used or supervised by cardiologists in
catheterization laboratories for blood pressure measurement such as the gradients and regurgitation
indices measurement.
The OptoMonitor 3 computes and displays information, based on the input from the OpSens pressure
guidewire, an Aortic Pressure transducer (AO) and optionally an ECG curve. The pressure data is
displayed as graphical curves and numerical values on the OptoMonitor 3 Display Unit (OpM3-DU)
screen.
For coronary procedures, data includes: real-time and mean Aortic (Pa) and Distal (Pd) blood
pressures, Pd/Pa, diastolic pressure ratio (dPR), Fractional Flow Reserve (FFR) and optionally an ECG
curve.
For structural procedures, data includes: real-time and systolic/diastolic Aortic (AO) and wire (LV)
blood pressures, heartrate, left-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 output is provided to send aortic pressure to the Cathlab Hemodynamic System.
In addition, the FFR value can be sent to the Cathlab Hemodynamic System 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
OptoMonitor 3 Display Unit 15” (OpM3-DU) REF F2321
3) OptoMonitor 3 Handle Unit (HU) REF F2330
4) OptoMonitor 3 DU Wireless dongle REF F2322
5) OU Power supply 30W 12V 2.5A REF F201003
6) DU Power supply cable, 20V F232012
7) AC power cord country specific power cord wall adapter
8) OptoMonitor 3 DU-OU communication cable REF F232009
9) OptoMonitor 3 DU-OU communication LAN cable REF F232010
10) AUX interface cable from hemodynamic system output
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. They may not necessarily reflect the data displayed on your OptoMonitor 3.
Rx Only
Caution: Applicable laws restrict this device to sale by, or on the order of, a licensed healthcare
practitioner.

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11) Pressure output cable to hemodynamic system input
12) Aortic Transducer interface cable
1.1 Indications for Use
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers,
coronary vessels and peripheral vessels, during interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the
diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
1.1.1 Intended user
The OptoMonitor 3 is intended to be used or supervised by cardiologists.
1.1.2 Intended environment
The OptoMonitor 3 is intended to be used in catheterization laboratories.
1.2 Contraindications
The system has no patient alarm functions. Do not use for cardiac monitoring. The system is
contraindicated for use in cerebral vasculature.
1.3 Safety
1.3.1 Warnings
•Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating condition.
•The power supply and cord used with the OptoMonitor 3 must be supplied by OpSens or
personnel authorized by OpSens to ensure compliance with local standards.
•To avoid explosion hazard, do not use the equipment in the presence 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 upgrades must be carried out by the personnel trained and authorized by
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; unplug the system from the power outlet and contact a qualified field service person and/or
OpSens authorized service person or OpSens.
•In the event of any anomalies observed on system, accessories or labels, please contact a qualified
field service person and/or OpSens authorized service person or OpSens.
•The OptoMonitor 3 has no patient alarm functions. The audio indicator is for system status
indications only.
•To avoid inadvertent disconnection, route all cables and secure excess cabling in a way to prevent
a stumbling and entanglement hazard.
•Power supply is specified as a part of ME EQUIPMENT or combination is specified as a ME SYSTEM.
Connection of equipment that do not follow relevant IEC standard for medical equipment (e.g.
IEC 60601) may lead to patient injury or death.
•Always keep portable RF communications equipment (including peripherals such as antenna
cables and external antennas) at least 30 cm (12 inches) from any part of the OptoMonitor 3,

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including cables specified by the manufacturer. Otherwise, degradation of the performance of
this equipment could result.
•The OptoMonitor 3 system is designed to be used nearby all devices that could potentially be
installed nearby to the location of its INTENDED use.
•OptoMonitor 3 cannot be used in homecare environment. This device is intended to be used in
properly equipped healthcare facilities, such as a Cathlab.
•Other equipment should not be stacked on-top of or in direct-contact with the OptoMonitor 3
system, otherwise there is risk of improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
•Use of accessories, transducers, and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
•Improper installation of the OptoMonitor 3 or other equipment may lead to interference of
OptoMonitor 3 function, even if that other equipment complies with CISPR EMISSION
requirements.
•When connecting to healthcare facility network, such as DICOM, connection shall be isolated.
•When connecting video output signal to an external device, connection shall be made with a
shielded cable. Connection shall also be isolated to provide protection against leaking current.
The user is responsible for compliance with the requirements of standard IEC 60601-1.
•OPM3 system must not be serviced or maintained while in use with the patient
•Assembly of OptoMonitor as part of a Medical Equipment System as well as modifications during
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 service life, the equipment, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such products. If you have any questions
concerning disposal of the equipment, 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 with the proper performance of the
equipment. For this reason, make sure that all external devices operated in the vicinity of the
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.
•Always install or carry the equipment properly to avoid damage caused by drop, impact, strong
vibration, or other mechanical force.
•Maintain at least 5 cm (2”) of clearance above the Optical Unit to ensure proper ventilation.
•Always leave the protective caps on the optical connector on the Handle Unit when the system is
not in use. Do not put any sharp object into the optical connector.
•Only OpSens’ pressure guidewire is intended to be connected to the optical connector on the
Handle Unit.
•Each pressure guidewire is matched with its unique cable and Gauge Factor Connector (where
applicable) supplied in the same package. Opsens’ pressure guidewire cable and Gauge Factor
Connector (where applicable) must be inserted into the Handle Unit to allow proper operation.
•External equipment intended for connection to Pa INPUT, Pa/Pd OUTPUT or other connectors,
shall comply with relevant IEC standard (e.g. IEC 60601 series for medical electrical equipment).