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.

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•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.
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.
Notes
•A warmup period (approximately 20 minutes) before the FFR or dPR 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 the OW has no electrical wires, there is no effect on the patient when using HF surgical
equipment. 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 HF
surgical equipment on the patient.
•Since the OW is an optical fiber, 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 close 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.

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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.
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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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 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
Date of manufacture; expressed in Year and Month
LOT
YYYY-MM
2797

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Manufacturer
Authorized European representative
Australian sponsor
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.
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.

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•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.

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2COMPLIANCE WITH REGULATORY REQUIREMENTS
Compliance with Standards and Directives
OptoMonitor 3 complies with the applicable portions of the following standards:
Council directive 93/42/EEC (Medical Device Directive).
CSA Standards:
CAN/CSA-C22.2 No. 60601-
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 This 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.
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

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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
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)

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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
environment. 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
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

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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.
(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.

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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 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.
RF Compliance
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.
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.