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