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Manufacturer’s Guide and Declaration– electromagnetic emissions
The HOWDY BABY device is intended to operate in the electromagnetic environment specied below. The
customer or user should ensure that it is used in that environment
Emission Test Compliance Electromagnetic Environment
Emissions RF
CISPR 11
Group 1 The medical device uses RF Energy only for its internal functioning.
Therefore, the RF emissions are very low and avoids signal
interferences with other nearby electronic devices.
The medical device is suitable to be used in any environments, including
domestic and all those environments that are directly connected to the
public low-voltage power supply network that supplies buildings used
for domestic purposes.
Emissions RF
CISPR 11
Class B
Immunity Test
IEC Test level
60601
Level of
compliance
Electromagnetic Environment
Electrostatic
discharge
± 8 kV contact
± 2, 4, 8, 15 kV
in air
± 8 kV contact
± 2, 4, 8, 15 kV
in air
30A/m 30A/m
Floor surfaces must be made of wood, concrete or
ceramic tiles. If the oor surfaces are coated with
synthetic materials, the relative humidity should be at
least 30%.
Power frequency magnetic elds should be at levels
characteristics of a typical location in a commercial or
hospital environment.
Magnetic eld at
mains frequency
(50/60 Hz)
Manufacturer’s declaration – Electromagnetic Immunity (Table 2, EN 60601-1-2)
The device is suitable for use in a specic electromagnetic environment. The patient or family member using the device
shall ensure that it is used in an electromagnetic environment as described below.
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