© 2012-2019 Baylis Medical Company Inc. 39 of 48 DMR RFP-100A 3.3 V-13 29-May-2020_EN.docx
9.5. IEC ELECTRICAL SAFETY AND EMC SPECIFICATIONS
Table 9.5-1 IEC Electrical Safety Specifications
Class I, Defibrillation proof Type CF Equipment, IPX0, not AP/APG
Mode of Operation: Constant (Continuous)
• Leakage current conforms to IEC 60601-1
• Dielectric withstanding voltage conforms
to IEC 60601-1
EMC Emissions and Susceptibility: The BMC Radiofrequency Puncture
Generator has been tested and found to comply with the limits for medical devices
to the IEC 60601-1-2:2014. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. This
Generator generates, uses, and can radiate radiofrequency energy and, if not
installed and used in accordance with the instruction given below, may cause
harmful interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in a particular installation.
Table 9.5-2 IEC EMC Specifications (Emissions)
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The BMC Radiofrequency Puncture Generator is intended for use in the
electromagnetic environment specified below. The customer or the user of the BMC
Radiofrequency Puncture Generator should assure that it is used in such an
environment.
Electromagnetic Environment –
Guidance
The BMC Radiofrequency Puncture
Generator must emit electromagnetic
energy in order to perform its intended
function. Nearby electronic equipment may
be affected.
The BMC Radiofrequency Puncture
Generator 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
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
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