LBL-2019-41-v4 OptoMonitor 3 IFU wTAVI_en Rev 2022-03
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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
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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