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Guidance And Manufacturer's Declaration - Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - F&P HumiGard SH870 Gebrauchsanleitung

Chirurgisches befeuchtungssystem
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GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC EMISSIONS
The SH870 Surgical Humidification system is intended for use in the electromagnetic environment specified below. The customer or the user of the
SH870 Surgical Humidification system should ensure that it is used in such an environment.
EMISSIONS TEST
RF EMISSIONS
CISPR 11
RF EMISSIONS
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions IEC 61000-3-3
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 Class A). If it used in a
residential environment (for which CISPR 11 Class B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating or re-orientating the equipment.
GUIDANCE AND MANUFACTURER'S DECLARATION – ELECTROMAGNETIC IMMUNITY
The SH870 Surgical Humidifier is intended for use in the electromagnetic environment specified below. The customer or the user of the SH870 Surgical
Humidifier should ensure that it is used in such an environment.
IMMUNITY TEST
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
input lines IEC 61000-4-11
Power frequency
(50/60 Hz) magnetic field
IEC 61000-4-8
Note: U
is the A.C. mains voltage prior to application of the test level.
T
COMPLIANCE
GROUP 1
CLASS A
CLASS A
Complies
IEC 60601
TEST LEVEL
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5% U
(>95% dip in U
T
T
for 0.5 cycle)
40% U
(60% dip in U
T
T
for 5 cycles)
70% U
(30% dip in U
T
T
for 25 cycles)
<5% U
(>95% dip in U
T
T
for 5 seconds)
30 A/m
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
The SH870 Humidifier uses RF energy only for its internal function.
Therefore, its RF emissions are very low and not likely to cause any
Interference in nearby electronic equipment.
The SH870 Humidifier is suitable for use in all establishments, including
domestic and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
COMPLIANCE LEVEL
± 8 kV contact
± 15 kV air
± 2 kV for power
supply lines
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
<5% U
(>95% dip in U
T
T
for 0.5 cycle)
40% U
(60% dip in U
T
T
for 5 cycles)
70% U
(30% dip in U
T
T
for 25 cycles)
<5% U
(>95% dip in U
T
T
for 5 seconds)
30 A/m
ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
Floors should be made of wood, concrete or ceramic tile.
If floors are covered with synthetic material, the Relative
Humidity should be at least 30%.
Mains-power quality should be that of a typical commercial
or hospital environment.
Mains-power quality should be that of a typical commercial
or hospital environment.
Mains-power quality should be that of a typical commercial
or hospital environment. If the user of the SH870 Surgical
Humidifier requires continued operation during power mains
usage, it is recommended that the SH870 Surgical Humidifier
be powered from an uninterruptible power supply or battery.
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or
hospital environment.
FISHER & PAYKEL HEALTHCARE
03

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