Tecno-gaz KYRI DSS, Instruction Manual

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GB
15
RISK OF ELECTROMAGNETIC INTERFERENCE AND POSSIBLE REMEDIES
This section contains information regarding the conformity of the compliance with the EN 60601-1-2 Standard.
The KYRI DSS surgical aspirator is an electro-medical device that requires particular precautions regarding electro-magnetic
compatibility and which must be installed and commissioned according to the electro-magnetic compatibility information supplied.
Portable and mobile radio communication devices (mobile phones, transceivers, etc.) may interfere with the medical device and
should not be used in close proximity with, adjacent to or on top of the medical device.
If such use is necessary and unavoidable, special precautions should be taken so that the electro-medical device functions properly in
its intended operating configuration (for example, constantly and visually checking for the absence of anomalies or malfunctions).
The use of accessories, transducers and cables different to those specified, with the exception of transducers and cables sold by the
appliance and system manufacturer as spare parts, can lead to an increase in emissions or in a decrease of the immunity of the device
or system. The following tables supply information regarding the EMC (Electromagnetic Compatibility) characteristics of the electro-
medical device.
Guidance and manufacturer’s declaration – Electromagnetic Emissions
The surgical aspirator KYRI DSS is intended for use in the electromagnetic environment specified below. The customers or the
user of the surgical aspirator KYRI DSS should assure that it’s used in such an environment.
Emissions Test Compliance Electromagnetic environment - guidance
Irradiated / Conducted
emissions CISPR11 Group 1 The surgical aspirator KYRI DSS only used RF energy only for its internal
functioning. Therefore its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Irradiated / Conducted
emissions CISPR11 Class [B] The appliance is suitable fopr use in alla establishments included
domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
EN 61000-3-2 Class [A]
Voltage fluctuations / flicker
emissions EN 61000-3-3 Complies
Guidance and manufacturer’s declaration – Immunity Emissions
The surgical aspirator KYRI DSS is intended for use in the electromagnetic environment specified below.
The customers or the user of the surgical aspirator KYRI DSS should assure that it’s used in such an environment.
Immunity Test Level indicated by
the EN 60601-1-2
Compliance
Level
Electromagnetic environments - guidance
Electrostatic discharge
(ESD)
EN 61000-4-2 ± 6kV on contact
± 8kV in air
The device
doesn’t change
its state
Floors should be wood, concrete or ceramic tile. If floors are
covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient / burst
EN 61000-4-4
± 2kV power supply
lines
± 1kV for input /
output lines
The device
doesn’t change
its state
Mains power quality should be that of a typical commercial
or hospital environment.
Surge
EN 61000-4-5 ± 1kV differential
mode
The device
doesn’t change
its state
Mains power quality should be that of a typical commercial
or hospital environment.
Volgate dips, short
interruptions and
voltage variations on
power supply input
lines
EN 61000-4-11 5%U
T
(>95% dip U
T
)
for 0.5 cycle
40%U
T
(>60% dip
U
T
) for 5 cycle
70%U
T
(>30% dip
U
T
) for 25 cycle
<5%U
T
(>95% dip
U
T
) for 5 sec
- Mains power quality should be that of a typical commercial
or hospital environment. If the user of the surgical aspirator
KYRI DSS requires continued operation during power
mains interruptions, it is recommended that the device be
powered from an uninterruptible power supply or a
battery.
Magnetic field
EN 61000-4-8 3A/m The device
doesn’t change
its state
The power frequency magnetic field should be measured in
the intended installation location to assure that it’s
sufficiently low.
Note U
T
is the value of the power supply voltage