Table 1 Compliance class
Emissions
Test
Compliance
Electromagnetic Environment and
Guidance
RF emissions
CISPR 11
Group 1
The equipment uses RF energy only for its
internal function.
Therefore, its RF emissions are very low and
are not likely to cause any interference in
nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
fluctuations/
flicker
emissions
IEC 61000-3-3
Complies
The equipment is suitable for use in all
establishments, including domestic
establishments and those directly connected
to the public low-voltage power supply
network that supplies buildings used for
domestic purposes.
Table 2- Compliance standards
Phenomenon
Basic
Standard of
Immunity Test
Level of
±8 KV contact
±2 KV, ±4 KV,
±8 KV,±15KV air
±8 KV contact
± 2 K V, ± 4 K V,
± 8 KV, ±15KV air
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
3V/m
80 MHz-2.7 GHz
80% AM at 1 KHz
See table
See table
±1 KV
100 KHz repetition
frequency
±1 KV
100 KHz repetition
frequency
Electrostatic
discharge
IEC 61000-4-2
Radiated RF
EM fields1
IEC 61000-4-3
Proximity
fields from RF
wireless
communication
equipment
IEC 61000-4-3
Electrical
Fast/Transients
bursts
IEC 61000-4-4
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0 .15 MHz
and 80 MHz
80% AM at 1KHz
3V
0.15 MHz-80 MHz
6 Vm in ISM bands
between 0.15 MHz
and 80 MHz
80% AM at 1KHz
Conducted
disturbances
induced by RF
fields.
IEC 61000-4-6
30 A/m
50 Hz or 60 Hz
30 A/m
50 Hz or 60 Hz
Rated power
frequency
magnetic fields
IEC 61000-4-8
The following tables provide information on compliance of the
equipment according to the standard EN 60601-1- 2:2015.
19
18
-The system must not be used adjacent or supported by other
equipment. The recommendations of this manual must be followed.
-Do not use accessories, transducers, internal parts of components
and other cables other than those previously specified by the
manufacturer. This may result in increased emission or decreased
electromagnetic immunity and result in improper operation.
-Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should by used no
closer than 30 cm to any part of the ultrasound system, including
cables specified by the manufacturer. Otherwise, degradation of
the performance of this equipment could result.
-To maintain basic safety in relation to electromagnetic
disturbances during the expected service life, always use the
system in the specified electromagnetic environment and follow the
maintenance recommendation described in this manual.