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).

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•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 5.11).
•OptoMonitor 3 is protected against the effects of a discharge of a defibrillator.
Readings may be temporarily affected by defibrillation.
•Ensure OptoMonitor 3 Handle Unit is not used in sterile environment.
•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. Responsible organisation should identify, analyse, evaluate
and control these risks.
•The following changes to IT-Network could introduce new risks that require additional analysis:
changes in network configuration, connection of additional items, disconnection of items, update
of equipment and upgrade of equipment.
•Hemodynamics parameters such as Aortic Regurgitation Index alone cannot provide basis for
clinical decision and their interpretation is left to physicians. Values should be interpreted by
comparing pre- to post-procedural measurements, along with other information available such as
imaging modalities.
1.3.3 Precautions
•To protect the privacy and security of sensitive information, including electronic protected health
information (EPHI), and to protect the integrity of the system itself, the system should be located
in a physically secure, access-controlled environment.
1.3.4 Notes
•A warmup period (approximately 20 minutes) before the procedure is recommended.
•Put the equipment in a location where you can easily see the screen and access the operating
controls. It is up to the user’s discretion to determine if the ideal display unit location is a wired-
bedside setup or a wireless-control room setup.
•Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when
needed.
•NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas
and healthcare facilities (CISPR 11 class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not offer adequate protection to
radio-frequency communication services. The user might need to take mitigation measures, such
as relocating or re-orienting the equipment.
•This device may use Bluetooth® 2.1+ EDR communication. The frequency band of this technology
is between 2400MHz and 2483.5MHz. Type and frequency characteristics of the modulation is
FHSS/GFSK. Effective radiated power is 2.5mW, Bluetooth® Class 2.
•Portable and mobile RF communications equipment can affect OptoMonitor 3.
•OptoMonitor 3 needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the manual.
•Any serious incident that occurs in relation to the device should be reported to the manufacturer
and the competent authority
•Since there is no conductive lead between the OpM3 and the OpSens pressure wires (optical
connection only), the OpM3 system does not add any additional danger during the use of HF
surgical equipment. For the aortic transducer input, please refer to the transducer manual for

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this information. The measurement taken by the OpM3 shall not be used during the use of a HF
surgical equipment on the patient.
•Since there is no conductive lead between the OpM3 and the OpSens pressure wires (optical
connection only), the OpM3 system does not add any additional danger during the defibrillation
of a patient. For the aortic transducer input, please refer to the transducer manual for this
information. The measurement taken by the OpM3 shall not be used during the use of a
defibrillator on the patient.
•This device should not be used in proximity to known sources of electromagnetic disturbance such
as diathermy, electrocautery, RFID, etc. as this equipment has not been tested for immunity to
specific sources of electromagnetic disturbance.
•Take the following precautions to prevent any adverse events to the patient and/or to the user in
case of electromagnetic disturbances:
oAlways refer to the information listed in the section 2.1 Compliance with Standards and
Directives.
oIn case of a signal noise, presumably caused by electromagnetic disturbances, first verify
the cabling, and then move any portable RF communications equipment and mobile
devices placed nearby as far away as possible to rule out interference.
oIf signal noise persists, move any nearby portable equipment even if it is not expected to
be an RF emitter as some RF emitters (e.g. RFID) might be concealed.
oStop using the device if the electromagnetic disturbances persist and contact a qualified
field service person and/or OpSens authorized service person or OpSens for assistance.
1.4 Storage and Handling
The OptoMonitor 3 is shipped non-sterile and must not be sterilized.
•Store system components in a clean environment away from humidity, magnets, and sources of
electromagnetic interference (EMI).
•System performance may be affected if OptoMonitor 3 is exposed to temperatures outside the
range showed in the symbols in section 1.5.
•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.

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1.5 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 the
product
Caution: Applicable laws restrict this device to sale by or on the order of a licensed
healthcare practitioner. Only physicians or other persons with adequate medical training
in catheter insertion procedures should use the OpSens OptoMonitor 3 system. Only
those personnel who are familiar with its operation and who have been trained to
perform the procedures for which the device is intended should use the system
Follow instructions for use
IPX0 rating: Limited protection against ingress of water
IPX2 rating: Protected against vertically falling drops of water
This marking indicates that this product should not be disposed with other household
wastes throughout the EU. To prevent possible harm to the environment or human
health from uncontrolled
waste disposal, recycle it responsibly to promote the
sustainable reuse of material resources. To return your used device, please use the return
and collection systems or contact the retailer where the product was purchased. They
can take this product for environmentally safe recycling
Pd Output to Cathlab Hemodynamic System
Pa Output to Cathlab Hemodynamic System
Pa Input/ECG Input from Cathlab Hemodynamic System
Pa Input from Aortic Transducer
Power button
Direct current
Defibrillation-proof type CF applied part
Keep dry
System model number
System serial number
LOT number
LOT
2797

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Date of manufacture; expressed in Year and Month
Manufacturer
Authorised European representative
Australian sponsor
Authorised representative for Switzerland
Relative humidity range for storage condition and system use
Atmospheric pressure range for storage condition
Temperature range for storage condition
Stacking limit
This side up
Fragile
Handle with care
Single use. This symbol applies only to OpSens’ pressure guidewires
Indicates equipment which emits radio-frequency signal.
Indicates equipment not to be used in MRI scanner room.
Indicates that an activation code is needed to use a software feature.
Medical device
YYYY-MM

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1.6 Cybersecurity
•OpSens makes no representation of warranty that use of the OptoMonitor complies with
applicable laws and regulations concerning data privacy, security and confidentiality.
OptoMonitor needs to be evaluated as a component of your system as you use, control, process
or transfer patient health information.
•It is hospital responsibility to ensure proper decommissioning process is followed with regard to
patient information stored on device.
•Access codes and passwords change frequency should be aligned with local hospital password
policies.
•To protect the integrity of the device as well as the privacy and security of sensitive information,
the system should be located in an access-controlled environment. Use of Locking password (ref
section 8.6.1) is recommended. Locking delay should be aligned with local hospital password
policies.
•Access codes and passwords are 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.
2COMPLIANCE WITH REGULATORY REQUIREMENTS
2.1 Compliance with Standards and Directives
OptoMonitor 3 complies with the applicable portions of the following standards:
CSA Standards:
CAN/CSA-C22.2 No. 60601-1:2014
CAN/CSA-C22.2 No. 60601-1:14: Medical Electrical Equipment - Part
1: General Requirements for Basic Safety and Essential Performance
CAN/CSA C22.2 No.60601-1-6:11 +
AMD1
Medical Electrical Equipment – Part 1-6: General Requirements for
basic safety and essential performance –
Collateral Standards:
Usability.
(Adopted IEC 60601-1-6:2010, third edition, 2010-01 + A1:2013 –
edition 3.1 Thi
s consolidated version consists of the third edition
(2010) and its amendment 1 (2013-10)).
CAN/CSA C22.2 No.60601-2-34:12
Medical Electrical Equipment – Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure
monitoring equipment.
ANSI/AAMI Standards:
ANSI/AAMI ES60601-
1:2005/(R)2012, AND C1:2009
AND A2:2010(R)2012
(Consolidated text - edition 3.1)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance (IEC 60601-1:2005+A1:2012, MOD).
IEC60601-1-6 :2010 + A1 :2013
Medical Electrical Equipment – Part 1-6: General requirements for
basic safety and essential performance –
Collateral standard:
Usability.

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IEC60601-2-34 :2011
Medical Electrical Equipment – Part 2-34: Particular requirements for
the basic safety and essential performance of invasive blood pressure
monitoring equipment.
IEC60601-1-2:2007
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance (third edition)
IEC60601-1-2:2014
Medical electrical equipment — Part 1-2: General requirements for
basic safety and essential performance —
Collateral Standard:
Electromagnetic disturbances —
Requirements and tests (fourth
edition)
ETSI Standards:
ETSI EN 301 489-17 V2.2.1
ElectroMagnetic Compatibility (EMC) standard for radio equipment
and services; Part 17: Specific conditions for Broadband Data
Transmission Systems; Harmonized Standard covering the essential
requirements of article 3.1(b) of Directive 2014/53/EU
ETSI EN 300 328 V2.2.1
Wideband transmission systems; Data transmission equipment
operating in the 2,4 GHz ISM band and using wide band modulation
techniques; Harmonized
Standard covering the essential
requirements of article 3.2 of Directive 2014/53/EU
FCC standards (US Code of Federal Regulations, Title 47, Part 15 (47 CFR 15))
FCC 15.247
Systems Using Digital Modulation
RSS-247
Digital Transmission Systems (DTSs), Frequency Hopping Systems
(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
Electromagnetic environment guidance
RF emissions
CISPR 11
Group 1
The equipment uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A
The OptoMonitor 3 is suitable for use in all
establishments other than domestic and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes.
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
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
standard or test
method
Compliance level
Electromagnetic
environment guidance

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Electrostatic
discharge (ESD) IEC 61000-4-2
±2,4,6 kV contact
±2,4,8 kV air
(IEC 60601-1-2 3
rd
edition)
Floors should be wood,
concrete
or ceramic tile. If
floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
±8 kV contact
±2,4,8,15kV air
(IEC 60601-1-2 4
th
edition)
Electrical fast
transient/burst IEC 61000-4-4
±2 kV @5kHz
power supply lines
±1 kV @5kHz input/output lines
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
environment
±2 kV @100 kHz
power supply lines
±1 kV @100 kHz input/output lines
(IEC 60601-1-2 4
th
edition)
Surge IEC 61000-4-5
±0.5,1 kV with 0, 90, 270º
differential mode
±0.5,1,2 kV common mode with 0 or
180, 90, 270º
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
environment
±0.5,1 kV with 0, 90, 180, 270º
differential mode
±0.5,1,2 kV common mode
(IEC 60601-1-2 4
th
edition)
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
5% / 0.5 cycle
40% / 12 cycles
70% / 30 cycles
0 and 180º
5% / 5s
(50 and 60Hz)
(IEC 60601-1-2 3
rd
edition)
Mains power quality should
be that of a typical
commercial or hospital
env
ironment. If the user of
OptoMonitor 3 requires
continued operation during
power mains interruptions,
it is recommended that
OptoMonitor 3 be powered
from an uninterruptible
power supply.
0% / 0.5 cycle
0% / 1 cycle,
70% / 30 cycles
80% / 300 cycles
0% / 300 cycles
at 0,45,90,135,180,
225,270,315º for 50 and 60Hz
(IEC 60601-1-2 4
th
edition)
Power
frequency
magnetic field
IEC 61000-4-8
3 A/m 50 and 60Hz
(IEC 60601-1-2 3
rd
edition)
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment
30 A/m 50 and 60Hz
(IEC 60601-1-2 4th edition)
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Manufacturer's declaration - Electromagnetic immunity

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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
standard or test
method
Compliance level
Electromagnetic environment guidance
Portable and mobile RF communication equipment should be used no closer to any part of OptoMonitor 3,
including cables, than the recommended separation distance calculated from the equation applicable to
the frequency of the transmitter.
Conducted RF IEC 61000-4-6
3Vrms - 0.15-80MHz;
(IEC 60601-1-2 3
rd
edition)
Recommended
separation distance:
d = 1,17√ P
3Vrms - 0.15-80MHz;
6Vrms in ISM bands, 80%AM @ 1kHz
(IEC 60601-1-2 4
th
edition)
Radiated RF IEC 61000-4-3
3V/m from
80 MHz to 2,5 GHz (IEC 60601-1-2 3rd
edition)
d = 1,17√ P 80 MHz to
800 MHz
d = 2,33√P 800 MHz to
2,5 GHz
3V/m from
80 MHz to 2,7 GHz (IEC 60601-1-2 4th
edition)
385MH z 27V/m
450MHz 28V/m
710MHz 9V/m
745MHz 9V/m
780MHz 9V/m
810MHz 28V/m
870MHz 28V/m
930MHz 28V/m
1720MHz 28V/m
1845MHz 28V/m
1970MHz 28V/m
2450MHz 28V/m
(IEC 60601-1-2 4th
edition additional RF
communication frequencies)
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey (a), should be
less than the compliance level in each frequency range (b).
Interference may occur in the vicinity of equipment marked with the following symbol:
Electro-surgery
IEC 60601-2-34
300W cut mode
100 W
coagulation mode
The OptoMonitor 3 essential performances
are not affected by electro-surgery
equipment due to the patient connection
being optic.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

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(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. 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. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or
relocating the OptoMonitor 3.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and OptoMonitor 3 as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum output
power of transmitter
(W)
Separation distance to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1,17√ P
80 MHz to 800 MHz
d = 1,17√ P
800 MHz to 2,5 GHz
d = 2,33√ P
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,69
3,69
7,38
100
11,67
11,67
23,33
OptoWire™, SavvyWire™, Handle Unit and Aortic transducer are CF and protected against the
effects of a discharge of a defibrillator. Pressure readings may be affected during defibrillation.
2.2 RF Compliance
2.2.1 United States
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates, uses and can radiate radio frequency
energy, and if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•Reorient or relocate the receiving antenna.
•Increase the separation between the equipment and receiver.
•Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
•Consult the dealer or an experienced radio/TV technician for help.

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2.2.2 Canada
This device complies with Industry Canada license exempt RSS standard(s). Operation is subject to the
following two conditions: (1) this device may not cause interference, and (2) this device must accept any
interference, including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de
licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire de
brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radioélectrique subi, même si le
brouillage est susceptible d'en compromettre le fonctionnement.
2.2.3 Japan
当該機器には電波法に基づく、技術基準適合証明等を受けた特定無線設備を装着している。
This equipment contains specified radio equipment that has been certified to the Technical Regulation
Conformity Certification under the Radio Law.
2.3 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 due to electromagnetic disturbance.
Essential performance Degradation observed
Electrical isolation for DC/DC converters in
interfaces for Aux, Pa inputs and output, Pd
output and HU interface
Noise or loss of functionality appearing during a patient
defibrillation.
Risk of fire or loss of isolation induced by
component failure and mitigated by fail-safe
functionalities
Unit doesn’t turn on, error on display unit or all LED on
OPM3 or flashing when turned on.
Protection against defibrillation Noise or loss of functionality appearing during a patient
defibrillation.
Accuracy of pressure measurements Noise on signal that are disturbing the average, loss of
signal, loss of connection HU device.
2.4 Deviation from the standards
There were no deviations from the applicable portions of the standards listed above during OptoMonitor
3 system compliance assessment