DTF MEDICAL Kitett MINIKIT DUO, Инструкция по эксплуатации

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EN
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY
IMMUNITY TEST TEST LEVEL (IEC 60601) COMPLIANCE LEVEL
Electrostatic discharge (ESD) (IEC 61000-4-2)
± 8 kV through direct contact
± 15 kV in the air
± 8kV
± 15kV
Fast transients and bursts (IEC 61000-4-4)
± 2 kV for power lines
± 1 kV for input/output lines
± 2kV
± 1kV
Transient overvoltage
(IEC 61000-4-5)
± 1kV phase-to-phase
± 2kV phase-to-earth
± 1kV phase-to-phase
± 2kV phase-to-earth
Voltage dips, short outages and voltage variations
on power supply input lines
(IEC 61000-4-11)
0% UT; 0.5 cycle
At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°
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; 1 cycle
and 70% UT; 25/30 cycles
Single phase: at 0°
Voltage interruption (IEC 61000-4-11) 0% UT: 250/300 cycles 0% UT: 250/300 cycles
Magnetic fi eld at power frequencies
(50/60 Hz) (IEC 61000-4-8)
30A/m 30A/m
RF interference
(IEC 61000-4-3)
10 V/m
80 MHz to 2.7 GHz
10 V/m
80 MHz to 2.7 GHz
385 MHz at 27 V/m
450MHz at 28V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450MHz at 28 V/m
5240, 5500, 5785MHz at 9 V/m
2450MHz at 28V/m
5240, 5500, 5785MHz at 9 V/m
385 MHz at 27 V/m
450MHz at 28V/m
710, 745, 780 MHz at 9 V/m
810, 870, 930MHz at 28V/m
1720, 1845, 1970MHz at 28V/m
2450MHz at 28 V/m
5240, 5500, 5785MHz at 9 V/m
2450MHz at 28V/m
5240, 5500, 5785MHz at 9 V/m
Radiated disturbances induced by RF (IEC 61000-
4-6)
3V
0.15 MHz - 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% mA at 1kHz
3V
0.15 MHz - 80 MHz
6V in ISM bands and amateur radio bands
between 0.15 MHz and 80 MHz
80% mA at 1kHz
SYMBOLS FEATURED IN AND ON THE DEVICE,
ACCESSORIES AND PACKAGING
Conformity with Directive 93/42/EEC
amended by Directive 2007/47/EC
on medical devices
Manufacturer
Reference
Batch number
Degree of protection:
2: Protected against penetration of solid
foreign bodies with a diameter
≥
12.5mm
2: Protection against drops of water falling
vertically when the device casing is tilted
up to 15º
Type BF applied part
Direct current
Refer to the operating instructions
Positioning of the batteries
Battery charge level
Device plugged into mains power
Fragile; handle with care
Store away from direct sunlight
Keep dry; moisture-sensitive
Temperature limit which must not be
exceeded in the case of operation, transport,
and storage
Moisture limit which must not be exceeded
in the case of operation, transport, and
storage
Atmospheric pressure limit which must
not be exceeded in the case of operation,
transport, and storage
ON/STANDBY
Do not throw in the trash; device placed on
the market after 13 August 2005
Material without bisphenol A
Polarity of the DC power connector
SYMBOLS FEATURED ON THE POWER SUPPLY
Mains adapter solely
intended for indoor use
The adapter complies with the safety
requirements of IEC 60601-1
Polarity of the DC power connector
Compliance with directives on low voltage
and electromagnetic compatibility
Class II appliance
Do not throw in the trash; device placed on
the market after 13 August 2005
Alternating current
Direct current
Pictograms 12