Opsens OptoMonitor 3 User manual

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

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1Contents
1. INTRODUCTION ...............................................................................................................................8
Indications for Use .......................................................................................................................9
Intended user ...................................................................................................................9
Intended environment......................................................................................................9
Contraindications.........................................................................................................................9
Safety ..........................................................................................................................................9
Warnings..........................................................................................................................9
Cautions ......................................................................................................................... 10
Precautions .................................................................................................................... 11
Notes ............................................................................................................................. 11
Storage and Handling................................................................................................................. 12
Symbols ..................................................................................................................................... 13
Cybersecurity............................................................................................................................. 14
2 COMPLIANCE WITH REGULATORY REQUIREMENTS........................................................................ 16
Compliance with Standards and Directives................................................................................. 16
RF Compliance ........................................................................................................................... 20
United States.................................................................................................................. 20
Canada ........................................................................................................................... 20
Japan.............................................................................................................................. 21
Essential performance ............................................................................................................... 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 Transducer Interface Cable)....................................................................... 24
Aortic Out (Pressure Output Interface Cable).................................................................. 24
Distal Out (Pressure Output Interface Cable) .................................................................. 24
OptoMonitor 3 Display Unit (OpM3-DU) .................................................................................... 24
Overview of the DU ........................................................................................................ 25
OptoMonitor 3 Handle Unit (OpM3-HU) .................................................................................... 26
Accessories ................................................................................................................................ 26
OptoWire Pressure Guidewire (not supplied).................................................................. 26
Aortic transducer (supplied by others) ............................................................................ 26
Audio and LED Indicators ........................................................................................................... 27
Audio Indicators ............................................................................................................. 27
Color Indicators .............................................................................................................. 28
Graphical User Interface ............................................................................................................ 29
Main Menu Screen Functions..................................................................................................... 32

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Playback Mode Functions .......................................................................................................... 33
Universal Menu Functions .............................................................................................. 35
Archive Menu functions.................................................................................................. 37
4 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.............................................................................................. 39
Connecting the Handle Unit ....................................................................................................... 40
Connecting to Mains Supply....................................................................................................... 41
Connecting to Cathlab Hemodynamic High-Level Aortic Output ................................................. 41
Connecting to Aortic Transducer (Aortic Input) .......................................................................... 41
Connecting Aortic Output to Cathlab Hemodynamic- compulsory when using the AO transducer
interface cable................................................................................................................................... 42
Connecting Distal Output 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 Info........................................................................................................................ 46
Pressure Scale............................................................................................................................ 46
Time Scale.................................................................................................................................. 47
Pullback Time Scale.................................................................................................................... 47
Pa, Pd, Pd/Pa, dPR Curves Color Selection.................................................................................. 48
Audio and Brightness level ......................................................................................................... 48
Averaging period........................................................................................................................ 49
Pd Delay..................................................................................................................................... 49
Input/Output Calibration with Cathlab Hemodynamic System, and Time/Date/Language
Adjustments via the Maintenance Menu ........................................................................................... 51
Accessing the Maintenance Menu .................................................................................. 51
Adjusting Time, Date and Language ................................................................................ 52
6 PATIENT CASE MANAGEMENT ....................................................................................................... 53
Opening a New Case .................................................................................................................. 53
Opening a New Case Without DICOM ............................................................................. 53
Opening a New Case from DICOM List ............................................................................ 54
Refreshing the DICOM list............................................................................................... 55
Ending an Open Case/ Starting a Second Case............................................................................ 55
7 PERFORMING an FFR OR dPR PROCEDURE..................................................................................... 56
Starting the System.................................................................................................................... 57

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Verifying Optimal Aortic Pressure Waveform and ensuring Pa Zero............................................ 57
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............................................................................................................... 59
Manual Zero................................................................................................................... 59
Equalization ............................................................................................................................... 60
Positioning Sensor Distal to Stenosis .......................................................................................... 60
Performing an FFR Procedure..................................................................................................... 61
Inducing Maximum Hyperemia....................................................................................... 61
Recording Pressure – FFR................................................................................................ 61
Performing a dPR Procedure ...................................................................................................... 62
dPR Calculation .............................................................................................................. 62
Performing a dPR Pullback.............................................................................................. 63
Viewing FFR, dPR, and Pullback 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
Creating or Updating Patient Information....................................................................... 68
Segments ....................................................................................................................... 70
Reviewing Data............................................................................................................... 72
Archiving Data ................................................................................................................ 72
Terminate Operation ................................................................................................................. 72
8 MAINTENANCE .............................................................................................................................. 73
Accessing the Maintenance Menu.............................................................................................. 73
Adjusting the Time, Date, and Language .................................................................................... 74
Input/output Calibration with Cathlab Hemodynamic System .................................................... 75
Calibrating Aortic Input Reference to Aortic Transducer ................................................. 75
Calibrating Aortic Input Reference to Cathlab Hemodynamic System.............................. 75
8.3.3 Calibrating Distal Output to Cathlab Hemodynamic System ............................................ 76
8.3.4 Calibrating Aortic Output to Cathlab System................................................................... 77
Reviewing Optical Sensor Performance...................................................................................... 77
Testing DICOM........................................................................................................................... 79
Testing DICOM ............................................................................................................... 79
Filtering the Modality Worklist ....................................................................................... 79
Display information on the Exported Images .................................................................. 80

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Security...................................................................................................................................... 80
Setting up a Startup Password ........................................................................................ 80
Changing the Maintenance Access Code......................................................................... 81
Reviewing Message History........................................................................................................ 81
Reviewing Network and Communication.................................................................................... 81
DU LAN1 connection to DICOM ...................................................................................... 81
DU-15” LAN2 connection to the Optical unit................................................................... 82
Wireless ......................................................................................................................... 82
Software Update for Display Unit or Optical Unit ....................................................................... 84
Factory Settings ......................................................................................................................... 84
DUMP Logs ................................................................................................................................ 84
Adjustable settings..................................................................................................................... 85
SETTINGS MENU............................................................................................................. 85
MAINTENANCE MENU Input/Output Calibration............................................................. 86
MAINTENANCE MENU Security....................................................................................... 86
MAINTENANCE MENU Network 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.................................................................................................. 90
Visual Inspection........................................................................................................................ 90
General Routine Inspection ............................................................................................ 90
Annual Visual Inspection................................................................................................. 90
Disposal ..................................................................................................................................... 91
11 TROUBLESHOOTING....................................................................................................................... 92
Verify the Connection of the OptoWire ...................................................................................... 92
OptoWire Zeroing Failed............................................................................................................ 92
OptoWire Zeroed Twice ............................................................................................................. 92
Aortic Input Zeroing Failed......................................................................................................... 93
Equalization Failed..................................................................................................................... 93
Re-Equalized .............................................................................................................................. 93
Resetting Equalization................................................................................................................ 93
GFC and OptoWire Mismatch..................................................................................................... 93
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

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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..................................................................................................... 103
22 Appendix B- Installation Checklists............................................................................................... 104

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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 computes and displays information, based on the input from the OpSens
pressure guidewire and an Aortic Pressure transducer (AO). The pressure data is displayed as
graphical curves and numerical values on the OptoMonitor 3 Display Unit (OpM3-DU) screen.
Data includes: real-time and mean Aortic (Pa) and Distal (Pd) blood pressures, Pd/Pa, diastolic
pressure ratio (dPR) and Fractional Flow Reserve (FFR).
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
11) Pressure output cable to hemodynamic system input
12) Aortic Transducer interface cable
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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Indications for Use
The OptoMonitor 3 is indicated for use to measure pressure in blood vessels including both coronary
and peripheral vessels, during diagnostic angiography and/or any interventional procedures.
Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for
the diagnosis and treatment of blood vessel disease.
Intended user
The OptoMonitor 3 is intended to be used or supervised by cardiologists.
Intended environment
The OptoMonitor 3 is intended to be used in catheterization laboratories.
Contraindications
The system has no patient alarm functions. Do not use for cardiac monitoring. The system is
contraindicated for use in cerebral vasculature.
Safety
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,
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.

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•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
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 OptoWire is matched with its unique cable and Gauge Factor Connector (where applicable)
supplied in the same package. OptoWire 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).
•Ensure the interface cables delivered with OptoMonitor 3 are compatible with the Cathlab
Hemodynamic System which is to be used with the OptoMonitor 3.
•Ensure to set proper pressure averaging (see section 5.6).
•OptoMonitor 3 is protected against the effects of a discharge of a defibrillator.
OptoWire readings may be temporarily affected by defibrillation.
•Ensure OptoMonitor 3 Handle Unit is not used in sterile environment.