10. EMC Informatie
Medische elektrische apparatuur is onderworpen aan speciale EMC-voorzorgsmaatregelen en moet worden
geïnstalleerd en in gebruik genomen overeenkomstig de EMC-instructies in de bijgevoegde documenten.
Draagbare en mobiele RF-communicatieapparaten (bijv. Mobiele telefoons) kunnen medische elektrische apparaten
beïnvloeden. Draagbare RF-communicatieapparatuur (inclusief randapparatuur zoals antennekabels en externe
antennes) mag niet worden gebruikt op een afstand van minder dan 30 cm (12 inch) tot een deel van de MiniScreen,
inclusief kabels die zijn opgegeven door de fabrikant. Anders kunnen de prestaties van het apparaat verslechteren.
Voor het gebruik van de MiniScreen volgens de instructies, mogen alleen de gespecificeerde accessoires in de
gebruiksaanwijzing worden gebruikt. Het gebruik van externe accessoires kan leiden tot verhoogde emissie en
verminderde immuniteit.
Guidelines and Manufacturer's Declaration – Electromagnetic Emissions
The MiniScreen is intended for use in an electromagnetic environment as specified below. The customer or user of the
MiniScreen should ensure that it is used in such an environment.
Emission Test
RF – Emission according to CISPR 11
RF – Emission according to CISPR 11
Harmonic Emissions according to
IEC 61000-3-2
Voltage Fluctuations / Flicker Emissions
according to IEC 61000-3-3
Guidelines and Manufacturer's Declaration – Electromagnetic Immunity
The MiniScreen is intended for the electromagnetic environment as specified below. The customer and user of the
MiniScreen should ensure that it is used in such an environment.
Immunity Test
Electrostatic Discharge (ESD)
IEC 61000-4-2
Electrical fast Transient / Burst
IEC 61000-4-4
Surges
IEC 610004-5
Voltage dips
IEC 61000-4-11
short interruptions and voltage
variations on power supply input
lines
IEC 61000-4-11
Power Frequency
(50/60 Hz) Magnetic Field
IEC 61000-4-8
Note
a
Compliance
Group 1
Class B
Not applicable
Not applicable
Table 1: Table 201 EN 60601-1-2, Electromagnetic Emissions
Test Specification
±8 kV contact
±15 kV air
± 2 kV for AC power line
± 1kV for input and output line
100 kHz
± 1 kV differential mode
± 2kV common mode
0% U
for ½ cycle (1 phase)
T
0% U
for 1 cycle
T
70% U
for 25/30 cycles
T
0% U
for 250/300 cycles
T
30 A/m
U
is the a.c. mains voltage prior to application of the test level.
T
25/250 cycles at 50 Hz or 30/300 cycles at 60 Hz
Table 2: Table 4, 5, 7, 8 EN 60601-1-2, Electromagnetic Immunity
Electromagnetic Environment - Guidelines
The MiniScreen uses RF energy only for it's internal
function. So it's RF emission is very low and it's
implausible
that
surrounding electronical devices.
The MiniScreen is suitable for the use in all
establishments, including domestic establishments and
those, which are connected to the public power supply,
which powers buildings for residential purposes.
Electromagnetic Environment - Guidance
Floors should consists of wood, concrete or
should be covered with ceramic titles. If the floor
is covered with synthetic material, the relative
humidity must be at least 30 %.
a
a
Pagina 13
it
cause
any
interferences
to