Warranty Obligations - Gima Nb-813C Bedienungsanleitung

WARRANTY OBLIGATIONS

1. Warranty for this compact compressor nebulizer is 12 months since the date of purchase.
2. The warranty obligations are prescribed by warranty certificate forbuyer.
WARNING:
• Do not modify this equipment without authorization of the manufacturer.
• All major maintains on the device must be performed by an authorized service center or distributor.
No use-serviceable parts inside, before being serviced by authorized representative or manufacturer.
CLASSIFICATION
• Equipment not suitable for use in the presence or flammable mixtures.
• Type BF applied part. Recognized the mask or mouthpiece as appliedpart.
• Internally powered equipment (without adapter), Class equipment (with adapter).
• Degree of protection against ingress of water is rated as lPX5
Manufacturer's Statement
Software development process of NB-813C comply with EN 62304.
Guidance and manufacturer's declaration-electromagnetic immunity
The model NB-813C Mesh Nebulizer is intended for use in the electromagnetic environment
specified below. The customer or the user of the model NB-813C Mesh 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,short interruptions
and voltage variations on power
supply input lines IEC 61000-
4-11:2004
Power frequency (50/60Hz)
magnetic field IEC 61000-4-8
Conducted RF
IEC 61000-4-6 : 2013
Radiated RFIEC
61000-4-3:2006+A1:2007+A2:
2010
Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
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 Model NB-813C Mesh Nebulizer is used exceeds the applicable RF compliance level
above, the Model NB-813C Mesh 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 NB-813C Mesh Nebulizer.
b.Over the frequency range 150KHz to 80MHz, field strength should be less than 3 V/m.
IEC 60601 test level
±8kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2kV for power supply lines
±0.5kV,± 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 sigle phase: at 0°
0% Ut,250 cycles
30 A/m
3V
150 kHz to 80 MHz
6 Vin ISM and between 0.15
MHz and 80 MHz
10V/m
80 MHz to 2.7 GHz
Compliance level
±8kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±2kV for power supply lines
±0.5kV, ± 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 cycles sigle phase: at 0°
0% Ut,250 cycles
30 A/m
3V150 kHz to 80 MHz
6V in iSM and between 0.15
MHz and 80 MHz
10V/m
80 MHz to 2.7 GHz
10V/m