GERATHERM GT-218C Manual De Instrucciones página 37

Appendix
Guidance and manufacture's declaration – electromagnetic emission
The GT-218C is intended for use in the electromagnetic environment specified below. The customer of the user of the GT-
218C should assure that it is used in such environment.
Emission test Compliance
RF emissions CISPR 11 Group 1
RF emission CISPR 11 Class B
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations /
flicker emissions Complies
IEC 61000-3-3
This unit confirms to EMC Standard EN 60601-1-2.
However, if it is used together with other medical devices or electrical equipment, they may influence the operations of one of
devices. Please follow any instructions in the manuals and use all devices correctly.
Test condition: Temperature: 20~25 °C, Relative humidity: 45%~60%, tested drugs: pure water 5ml. Compressor nebulizer with
respect to electric shock, fire and mechanical hazards and mechanical hazards in accordance with IEC60601-1.
MANUFACTURER'S DECLARATION
Guidance and manufacturer's declaration – electromagnetic immunity
The model GT-218C nebulizer is intended for use in the electromagnetic environment specified below. The customer or the
user of the model GT-218C nebulizer should assure that is used in such an environment.
Immunity test
Electrostatic discharge (ESD)
IEC 61000-4-2:2008
Electrical fast transient/burst
IEC 61000-4-4:2012
Surge IEC 61000-4-5:2005
Voltage dips, shot interruptions and
voltage variations on power supply
input lines IEC 61000-4-11:2004
Power frequency (50/60 Hz) magnetic
field IEC 61000-4-8:2009
Conducted RF
IEC 61000-4-6:2013
Radiated RF
IEC 61000-4-3:2006+A1:2007+A2:2021
Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field strength from fixed transmitters, such as base stations for radio telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength
in the location in which the GT-218C nebulizer is used exceeds the applicable RF compliance level above, the Model GT-218C
nebulizer should be observed to verify normal Operation. If abnormal performance is observed, additional measures may be
necessary. such as re-orienting or relocating the Model GT-218C nebulizer.
b Over the frequency range 150KHz to 80MHz, field strength should be less than 3 V/m.
Electromagnetic environment – guidance
The GT-218C uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
The GT-218C is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
IEC 60601 test level
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
±2 kV for power supply lines
±0,5 kV,
±1 kV line(s) to lines
0% UT ,0.5 Cycle at 0° ,45° ,90°, 135°,
180°, 225°, 270° and 315°
0% UT, 1 Cycle and 70% UT,
25/30 cycles single phase: at 0°
0% UT, 250/300 cycles
30 A/m
3V
150 kHz and 80 MHz
6 V in ISM and between
0.15 MHz and 80 MHz
10 V/m
80 MHz to 2.7 GHz
37
Compliance level
±8 kV contact
±2 kV, ±4 kV,
±8 kV, ±15 kV air
±2 kV for power supply lines
±0,5 kV,
±1 kV line(s) to lines
0 % UT, 0.5 Cycle at 0°, 45°, 90°, 135°,
180°, 225°, 270° und 315°
0 % UT, 1 Zyklus and 70 % UT,
25 Zyklen single Phase: bei 0 °
0 % UT, 250 Zyklen
30 A/m
3V
150 kHz and 80 MHz
6 V in ISM and between
0.15 MHz and 80 MHz
10 V/m
EN