Transonic HT331-FT - Appendix F: EMC Tables Aureflo System

44 AU-OPR-AureFloFT-EN,
Rev H
Appendix F: EMC Tables AureFlo System
In accordance with EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for
safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
i) “Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in the Accompanying
Documents” (the following tables).
ii) “Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.”
iii) “The equipment or system should not be used adjacent to or stacked with other equipment
and that if adjacent or stacked use is necessary, the equipment or system should be observed to
verify normal operation in the conguration in which it is used.”
iv) The emissions characteristics of this equipment make it suitable for use in industrial areas and
hospitals (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
reorienting the equipment.
The following tables provide information regarding the EMC characteristics of this Medical Electrical
Equipment, the AureFlo System excluding the HT300-Series Meter.
Table 201 — Guidance and Manufacturer’s Declaration -
Electromagnetic Emissions
GUIDANCE AND MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS
AureFlo
®
is intended for use in the electromagnetic environment specied below.
The customer or user of AureFlo
®
should ensure that it is used in such an environment.
EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT-GUIDANCE
RF emissions
CISPR 11
Class A
AureFlo
®
uses RF energy in the ow measurement function.
The equipment should not be used adjacent to or stacked
with other equipment and that if adjacent or stacked use is
necessary, the equipment should be observed to verify normal
operation in the conguration in which it is used.
Transmitters, as determined by an electromagnetic site survey,
should be less than the compliance levels (V1 and E1).
Conducted emissions
CISPR 11
Class A
AureFlo
®
is suitable for use in all establishments, including
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 uctuations
/Flicker emissions
IEC 61000-3-3
Complies