Performance Criteria - GEM FLOW COUPLER Manual

Performance Criteria

Failures include any time the unit does not produce an audible signal when detectable flow is present.
In addition to component malfunction, failures also include units that produce a false audible that is
indistinguishable from a signal produced by flow. Non-intentional audible signal tones are allowed to be
produced by the unit, so long as they cannot be easily mistaken for flow.
The equipment or system may exhibit performance degradation (e.g., deviation from specifications) that does
not affect essential performance or safety.
Guidance and manufacturer's declaration – electromagnetic emissions
The 20 MHz FLOW COUPLER Monitor system is intended for use in the electromagnetic environment specified below. The user of the 20 MHz FLOW COUPLER Monitor should assure that it is used
in such an environment.
Emission Test
RF Emissions, CISPR 11:2015 +A1:2016
RF Emissions, CISPR 11:2015 +A1:2016
Harmonic Current Emissions
IEC 61000-3-2:2014
Voltage Fluctuations and Flicker
IEC 61000-3-3:2013
9.
Compliance Electromagnetic Environment - guidance
Group 1 The 20 MHz FLOW COUPLER Monitor system 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.
Class A The 20 MHz FLOW COUPLER Monitor meets the conducted and radiated performance requirements for non-life supporting
equipment and also meet the harmonic current emissions, and voltage fluctuations (flicker) requirements for non-life
Class A supporting equipment pursuant to IEC 60601-1-2:2014.
The 20 MHz FLOW COUPLER Monitor is suitable for use in all establishments other than domestic, and may be used in
domestic establishments and those directly connected to the public low-voltage power supply network that supplies
Complies
buildings used for domestic purposes, provided the following warning is heeded:
Caution the FLOW COUPLER Monitor is intended for use by healthcare professionals only. The FLOW COUPLER Monitor
and system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the 20 MHz FLOW COUPLER Monitor system or shielding the location.