LBL-2008-41-v5 OptoMonitor 3 IFU_en Rev 2021-08
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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:
o
Always refer to the information listed in the section 2.1 Compliance with Standards and
Directives.