ResMed 2011-09 Ventilation Hood User Manual


 
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Notes:
The manufacturer reserves the right to change these specification
s without notice.
Pressure may be displayed in cm H
2
O or hPa.
Guidance and manufacturer’s declaration – electromagnetic
emissions and immunity
Medical Electrical Equipment needs special precautions regarding EMC and needs to be
installed and put into service according to EMC information provided in this document.
IEC 60601-1
classif
ications
Class II (Clause 3.14—double insulation). This
adherence means the need for an protective earthing
(ie, an earthed plug) is not necessary.
Type BF
Continuous operation
Air travel requirements Medical-Portable Electronic Devices (M-PED) that meet
the Federal A
viation Administration (FAA) requirements
of RTCA/DO-160 can be used during all phases of air
travel without further testing or approval by the airline
operator. ResMed confirms that the Stellar meets RTCA/
DO-160 requirements.
This device is not suitable for use in the p
r
esence of a flammable anesthetic mixture.
Guidance and manufacturer’s declaration – electromagnetic emissions
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
device should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR11 Group 1 The device 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.
RF emissions CISPR 11 Class B The device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage network that
supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/Flicker
Emissions IEC 61000-3-3
Complies
Warnings: The device should not be used adjacent to or stacked with other equipment.
If adjacent or stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
The use of accessories (eg, humidifiers) other than those specified in this manual is not recommended. They may
result in increased emissions or decreased immunity of the device.
Guidance and manufacturer’s declaration – electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the
de
vice should assure that it is used in such an environment.
Immunity test
IEC60601-1-2 test
lev
el
Compliance level Electromagnetic environment –guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV
±1 kV
Mains power quality should be that of a typical
commercial or hospital environment.
Surge IEC
61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.