The following tables provide information on compliance
of the equipment according to the standard
EN 60601-1- 2:2015.
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.
●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 30cm
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.
14
15
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
