Guidance And Manufacturer's Declaration - Tommee Tippee Made for Me Manual Del Usuario

Guidance and Manufacturer's Declaration

Important information regarding Electro Magnetic Compatibility (EMC)
This electrical medical equipment needs special precautions regarding EMC and put into
service according to the EMC information provided in the user manual; The equipment
conforms to this IEC 60601-1-2:2014 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The equipment with no ESSENTIAL PERFORMANCE is intended used in Home
healthcare environment
• WARNING: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary,
this equipment and the other equipment should be observed to verify that they are
operating normally".
• The 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.
• WARNING: Portable RF communications equipment (including peripherals such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the 1183, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result."
• WARNING: If the use location is near (e.g. less than 1.5 km from) AM, FM or TV
broadcast antennas, before using this equipment, it should be observed to verify
that it is operating normally to assure that the equipment remains safe with regard to
electromagnetic disturbances throughout the expected service life.
EMI Compliance Table (Table 1)
Table 1 - Emission
Phenomenon
RF emissions
Harmonic distortion
Voltage fluctuations
and flicker
EMI Compliance Table (Table 2-5)
Table 2 - Enclosure Port
Phenomenon
Electrostatic Discharge
Radiated RF EM field
Proximity fields from RF wireless
communications equipment
Rated power frequency magnetic fields
Compliance
CISPR 11
Group 1, Class B
IEC 61000-3-2
Class A
IEC 61000-3-3
Compliance
Basic EMC
standard
IEC 61000-4-2
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
Electromagnetic environment
Home healthcare environment
Home healthcare environment
Home healthcare environment
Immunity test levels
Home healthcare environment
±8 kV contact
±2kV, ±4kV, ±8kV, ±15kV air
10V/m 80MHz-2.7GHz 80% AM at 1kHz
Refer to table 3
30A/m
50Hz or 60Hz
25