5.1 Declaration - Electromagnetic Emissions
5. EMC Information
The electromagnetic compatibility (EMC) of the inspired™ O2FLO is designed according
to Medical Electrical Equipment Part 1-2 General requirement on safety (IEC60601-1-2),
Collateral Standard: Requirements and Tests for Electromagnetic Compatibility and the
device complied with the requirements. In certain circumstances, the unit may affect or
be affected by nearby equipment due to the effects of electromagnetic interference. If
this should happen, move the unit or the location of the unit causing interference, or
alternatively consult your homecare provider.
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
Emissions test
Compliance
Electromagnetic environment - guidance
The model VUN-001 is intended for use in the electromagnetic environment
specified below. The customer or the user of the model VUN-001 should assure that
it is used in such an environment.
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
The model VUN-001 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 model VUN-001 is suitable for used in
domestic establishment and in establishment
directly connected to a low voltage power supply
network which supplies buildings used for
domestic purposes.
Group 1
Class B
Class A
Complies
RF emissions
CISPR 11
39
40
4.7 Main Unit Leakage Test
Install a VHC60 chamber to the device. Connect the spike to a water bag. Tightly cover
the chamber outlet with cap. Run the machine ensuring no gas is escaping through the
chamber outlet. The stable flow rate displayed on screen should be less than 1 L/min
for at least 30s. If the flow rate is higher than 1 L/min your device may have a leak in the
gas path. Please contact Vincent Medical, your Vincent Medical supplier or authorized
personnel for repair.
STERILE
WATER
