Thoratec HeartMate III, Инструкция по эксплуатации

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B
HeartMate III Left Ventricular Assist System Instructions for Use B-19
Declaration and Guidance for Electromagnetic Disturbances for
Battery Charger
The HeartMate Battery Charger is suitable for use in the following environments:
• Hospitals, including ORs and emergency rooms
• Homes, workplaces and retail places
• Public or private passenger watercraft/boats, ferries, etc.
Table B.5 Declaration and Guidance Concerning Electromagnetic Disturbances for Battery Charger
HEARTMATE BATTERY CHARGER
EM Disturbance type /
Standards
IEC 60601-1-2 (2014)
Compliance Level
Use Environment Guidance
RF Emissions /
CISPR 11
EN 55011 Group 1, Class B
30 – 1,000 MHz
The HeartMate Battery Charger is suitable
for use in all establishments, including
domestic establishments and those
directly connected to the public
low-voltage power supply (mains) network
that supplies domestic (residential)
buildings.
The HeartMate Battery Charger uses RF
energy only for its internal purposes and
thus has low unintentional RF emissions
and is unlikely to cause interference in
nearby electronic equipment.
Harmonic Emissions /
IEC 61000-3-2
EN 61000-3-2
Class A
Voltage Fluctuations &
Flicker Emissions /
IEC 61000-3-3
EN 61000-3-3
Complies fully
Electrostatic Discharge
(ESD) Immunity /
IEC 61000-4-2
EN 61000-4-2
±6 kV Contact
±8 kV Air
Flooring material should be wood or tile.
If flooring is synthetic, the relative
humidity should be at least 30%. Higher
relative humidity will reduce the severity
of ESD events.