Regulatory and Safety Information
WARNING:
PATIENT SAFETY/EQUIPMENT FAILURE - Use of accessories, transducers and cables
other than those specified or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
Guidance and Manufacturer’s Declaration—Electromagnetic Emissions
The system described in this document is intended for use in the specified
electromagnetic environment below. It is the responsibility of the customer or user to
make sure that this system is used in such an environment.
Table 131: EMC Emissions Test
Emissions Test Compliance
RF emissions (Radiated)
EN 55011
Group 1
Class B
RF emissions (Conducted)
EN 55011
Group 1
Class B
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/Flicker emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declaration—Electromagnetic Immunity
The system described in this document is intended for use in the specified
electromagnetic environment below. It is the responsibility of the customer or user to
make sure that this system is used in such an environment.
Table 132: EMC Immunity Test
Immunity Test EN60601 Test Level Compliance Level
Electrostatic discharge (ESD)
IEC 61000-4-2
± 8 kV contact
± 15 kV air
± 8 kV contact
± 15 kV air
Electrical Fast Transient/burst
(EFT)
IEC 61000-4-4
± 2 kV for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines
± 1 kV for input/output lines
Surge
IEC 61000-4-5
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
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5 A5/MAC
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