Consequences Of Electrostatic Or Electromagnetic Discharges; Guidance And Manufacturer's Declaration Tables - Sophysa PRESSIO 2 Notice D'utilisation

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NOTE
The emission characteristics of the Monitor make it
suitable for use in industrial areas and hospitals (CISPR
11 class A).
If it is used in a residential environment (for which
CISPR 11 class B is normally required), the Monitor
might not offer adequate protection to radio-frequency
communication services. The user might need to take
mitigation measures, such as relocating or re-orienting
the equipment.
18.1. CONSEQUENCES OF ELECTROSTATIC OR
ELECTROMAGNETIC DISCHARGES
18.1.1. On the Monitor, the cables or the sensor
In case of electrostatic discharge or electromagnetic disturb-
ance, find below the behavior that the Monitor, the cables or
the sensor might have:
– If a strong electrostatic discharge occurs on the Monitor,
the cables or the sensor:
– the mean ICP or ICT value can be temporarily affected,
– the ICP curve can show temporary peaks of high ampli-
tude.
– If an electrostatic discharge occurs near the Monitor, tem-
porary error "E001", "E002" or "E005" may display on the
Monitor.
– If an electromagnetic disturbance occurs on the Monitor,
the cables or the sensor:
– the mean ICP or ICT value can be affected,
– the ICP curve can show abnormal ripples.
18.1.2. On the USB ports
The USB ports (USB 2.0 port and Mini-USB port) might also
be impacted by electrostatic discharges.
NOTICE
The USB 2.0 port can be damaged by important elec-
trostatic discharges. In this case, return the Monitor to
the after-sales service.
NOTICE
If a strong electrostatic discharge occurs on one of the
USB ports, the internal power supply may be damaged.
Return the Monitor to the after-sales service.
NOTE
If a strong electrostatic discharge occurs on one of the
USB ports, the Moniteur may restart automatically.
18.1.3. On the Monitor outlets and inlet
NOTICE
In an electrostatic discharge occurs on the ICP or ICT
outlets, or on the catheter extension cable inlet, their
functions may be damaged or may cease to function.
Return the Monitor to the after-sales service.
18.2. GUIDANCE AND MANUFACTURER'S DECLARA-
TION TABLES
Guidance and manufacturer's declaration – Electromagnetic
emissions
The Monitor is intended to be used in the electromagnetic environ-
ment specified below. The customer or user of the Monitor should as-
sure that it is used in such an environment. Deviations from emission
and immunity environment for this device may affect its expected
service life.
Emission test
Compliance
RF emissions
Group 1
CISPR 11
RF emissions
Class A
CISPR 11
Harmonic distortion
Class A
IEC 61000-3-2
Voltage fluctuations
Compliant
and flicker
IEC 61000-3-3
Guidance and manufacturer's declaration – Electromagnetic im-
munity
The Monitor is intended to be used in the electromagnetic environ-
ment specified below. The customer or user of the Monitor should as-
sure that it is used in such an environment. Deviations from emission
and immunity environment for this device may affect its expected
service life.
Immunity
Test level
test
IEC60601-1-2
Electrostatic
±8 kV on con-
Discharge
tact
(ESD)
± 2 kV, ± 4 kV, ±
IEC
8 kV, ± 15 kV in
61000-4-2
air
Radiated RF
3 V/m
EM Fields
80 MHz –
IEC
2.7 GHz
61000-4-3
80 % AM at
1 kHz
Electromagnetic environment
– Guidance
The Monitor uses RF energy
only for its internal functions.
Consequently, its RF emissions
are very low and are not likely
to cause any interference with
nearby electronic equipment.
The Monitor is suitable for use
in all establishments, including
domestic establishments and
those directly connected to the
public supply network for low
voltage electricity supplying
buildings for domestic use.
Compliance
Electromagnetic
level
environment
Guidance
±8 kV on con-
Floors should be of
tact
wood, concrete or
ceramic
tiles.
± 2 kV, ± 4 kV, ±
floors are covered
8 kV, ± 15 kV in
with synthetic ma-
air
terial, relative hu-
midity should be at
least 30%.
Transient phenom-
ena may occur on
the ICP curve.
3 V/m
WARNIN
80 MHz –
G
2.7 GHz
Portable
RF
80 % AM at
communica-
1 kHz
tions
equip-
ment (includ-
ing peripher-
als such as
antenna
ca-
bles and ex-
ternal anten-
nas)
should
be used no
closer
than
30 cm (12 in-
ches) to any
part
of
the
Monitor,
Page 33 of 174
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in-

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