mectron COMPACT PIEZO LED - Points of Contact with the Patient

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COMPACT PIEZO LED
6.1.3.2 PointsofContactwiththePatient
compactpiezoLEDisdesignedtooperateintheelectromagneticenvironmentspeciedbelow.
The customer or user of compact piezo LED should always make sure that it is used only in such
an environment.
Phenomenon
BasicEMC
standardortest
method
Immunitytestlevels
Electromagnetic
environment-Guidance
Electrostatic
discharges
(ESD)
c)
IEC61000-4-2
±8 kV on contact
±2 kV, ±4 kV, ±8 kV,
±15 kV in air
Theoormustbemadeof
wood, concrete or ceramic
tiles.Iftheooriscovered
with synthetic material, the
relative humidity should be at
leastequalto30%.
Conducted
disturbances
inducedbyRF
elds
a)
IEC61000-4-6
3 V
b)
0,15 MHz - 80 MHz
6V
b)
in ISM bands
between 0,15 MHz and
80 MHz
80%AMa1KHz
PortableandmobileRF
communication devices
should not be used near any
part of the product, including
cables, except when they
respect the recommended
distances, calculated from the
equation applicable at the
frequency of the transmitter.
 a) The following apply:
• All PATIENT-COUPLED cables shall be tested, either
individually or bundled
• PATIENT-COUPLED cables shall be tested using a
current clamp unless a current clamp is not suitable.
In cases were a current clamp is not suitable, an EM
clamp shall be used.
• No intentional decoupling device shall be used
between the injection point and the PATIENT
COUPLINGPOINTinanycase.
• Testing may be performed at other modulation
frequenciesidentiedbytheRISKMANAGEMENT
PROCESS.
• Tubesthatareintentionallylledwithconductive
liquids and intended to be connected to a PATIENT
shall be considered to be PATIENT-COUPLED cables.
• If the frequency stepping skips over an ISM or
amateur radio band, as applicable, an additional test
frequency shall be used in the ISM or amateur radio
band. This applies to each ISM and amateur radio
bandwithinthespeciedfrequencyrange.
• TheISM(industrial,scienticandmedical)bands
between0,15MHzand80MHzare6,765MHzto
6,795MHz;13,553MHzto13,567MHz;26,957MHz
to27,283MHz;and40,66MHzto40,70MHz.The
amateur radio bands between 0, 15 MHz and 80 MHz
are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz
to5,4MHz,7MHzto7,3MHz,10,1MHzto10,15
MHz,14MHzto14,2MHz,18,07MHzto18,17MHz,
21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0
MHzto29,7MHzand50,0MHzto54,0MHz.
 b) R.M.S., before modulation is applied.
 c) Discharges shall be applied with no connection to
anarticialhandandnoconnectiontoPATIENT
simulation. PATIENT simulation may be connected
after the test as needed in order to verify BASIC
SAFETYandESSENTIALPERFORMANCE.