Guidance and Manufacturer’s Declaration
B-6 EarlyVue VS30 Instructions for Use
Table B-5 Signal Input/Output Port
Table B-6 Patient Coupling Port
Immunity Test Immunity Test Level Compliance Level
Electromagnetic
Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2, ±4, ±8, ±15 kV air
±8 kV contact
±2, ±4, ±8, ±15 kV air
The EarlyVue VS30
vital signs monitor is
suitable for use in a
professional
healthcare facility
environment.
Electrical fast
transient/burst
IEC 61000-4-4
± 1 kV ± 1 kV
Surge
Line(s) to Ground:
IEC 61000-4-5
±1 kV ±1 kV
Conducted
disturbances
induced by RF fields
IEC 61000-4-6
3 V
0.15 MHz – 80 MHz
6 V in ISM bands
between 0.15 MHz and
80 MHz
3 V
0.15 MHz – 80 MHz
6 V in ISM bands
between 0.15 MHz and
80 MHz
Immunity Test Immunity Test Level Compliance Level
Electromagnetic
Environment -
Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2, ±4, ±8, ±15 kV air
±8 kV contact
±2, ±4, ±8, ±15 kV air
The EarlyVue VS30 vital
signs monitor is suitable
for use in a professional
healthcare facility
environment.
Conducted
disturbances
induced by RF fields
IEC 61000-4-6
3 V
0.15 MHz – 80 MHz
6 V in ISM bands
between 0.15 MHz and
80 MHz
3 V
0.15 MHz – 80 MHz
6 V in ISM bands
between 0.15 MHz and
80 MHz