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