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.
Ɣ7KHFRPSOLDQFHZLWK(0&DQG(0,UHJXODWLRQFDQQRWEHJXDUDQWHHGE\
the use of modified cables or those which does not comply with the same
standards under what the equipment was validated.
Ɣ7KHV\VWHPPXVWQRWEHXVHGDGMDFHQWRUVXSSRUWHGE\RWKHUHTXLSPHQW
The recommendations of this manual must be followed.
Ɣ'RQRWXVHDFFHVVRULHVWUDQVGXFHUVLQWHUQDOSDUWVRIFRPSRQHQWVDQG
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.
Ɣ3RUWDEOH5)FRPPXQLFDWLRQVHTXLSPHQWLQFOXGLQJSHULSKHUDOVVXFKDV
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.
Ɣ7RPDLQWDLQEDVLFVDIHW\LQUHODWLRQWRHOHFWURPDJQHWLFGLVWXUEDQFHVGXULQJ
the expected service life, always use the system in the specified
electromagnetic environment and follow the maintenance recommendation
described in this manual.
ⒻⒾ
ⒻⒿ
Table 2- Compliance standards
Phenomenon
Basic
Standard of
Immunity Test Level of
.9FRQWDFW
±2 KV, ±4 KV,
.9.9DLU
.9FRQWDFW
± 2 K V, ± 4 K V,
.9.9DLU
3V/m
0+]*+]
$0DW.+]
3V/m
0+]*+]
$0DW.+]
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+]0+]
6 Vm in ISM bands
between 0 .15 MHz
DQG0+]
$0DW.+]
3V
0+]0+]
6 Vm in ISM bands
between 0.15 MHz
DQG0+]
$0DW.+]
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
,(&
The following tables provide information on
compliance of the equipment according to the
standard EN 60601-1- 2:2015.