BD Veritor Plus System Mode D'emploi page 18

BD Veritor™ InfoWiFi Instructions
6 Electromagnetic Compatibility (EMC) Compliance Information
The BD Veritor™ Plus Analyzer has been evaluated to and conforms to the IEC 60601-1-2:2014
standard for Electromagnetic Compatibility (Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
disturbances – Requirements and tests) while maintaining operation of automated components and
avoiding the introduction of safety hazards to the user, except for ESD (Electrostatic Discharge) test
levels. This product also complies with EN 61326-2-6:2013 (Electrical equipment for measurement,
control and laboratory use. EMC requirements. Particular requirements. In vitro diagnostic [IVD]
medical equipment).
The system is not intended to be used with any accessory or cable not provided or directed for use
by BD. Use of accessories or cables not specified by BD can result in reduced electromagnetic
compatibility performance.
The system should be installed such that it is not directly adjacent to or stacked with other electrical
devices. If constraints do not allow for spacing between devices, both the BD Veritor™ Plus Analyzer
and the other device or devices should be monitored to verify that operation is not affected. In the
event that changes in operation are observed, including motion or processing errors, please contact
the BD service department immediately.
Portable RF communication equipment including external antennas can affect medical electrical
equipment. As such, these should be used no closer than 30 cm (12 inches) to any part of the
system, including any cable specified BD. Disregarding this can result in reduced electromagnetic
compatibility performance.
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
re-orienting the equipment.
This equipment should be installed and operated with a minimum distance of 20 cm between the
radiator and your body.
Refer to the tables below regarding the electromagnetic compatibility environment where the device
is intended to be used.
EMISSIONS
Phenomenon
Conducted Emissions
Radiated Emissions
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Basic EMC Standard
EN 55011: 2009 +A1: 2010
EN 55011: 2009 +A1: 2010
Limits
Class A
Class A