Devilbiss Guidance And Manufacturer's Declaration; Guidance And Manufacturer's Declaration - Electromagnetic Emissions; Guidance And Manufacturer's Declaration - Electromagnetic Immunity - DeVilbiss Drive Guide D'instructions

Oxygen Concentration vs Flow Rate
Flow L/m
%O
2
10 87% - 92%
9 87% - 93%
8 87% - 95%
7 87% - 96%
6 87% - 96%
5 87% - 96%
4 87% - 95%
3 87% - 95%
2 87% - 94%

DEVILBISS GUIDANCE AND MANUFACTURER'S DECLARATION

WARNING
Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the Electromagnetic
Compatibility [EMC] information provided in the accompanying documents.
Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment.
The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the equipment or
system should be observed to verify normal operation in the configuration in which it will be used.
NOTE– The EMC tables and other guidelines provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the
Electromagnetic Environment of use, and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without
disturbing other Equipment and Systems or non-medical electrical equipment.
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The 1025DS, 1025KS and 1025UK Oxygen Concentrators are intended for use in the electromagnetic environment specified below. The customer or the user of the
Concentrator should assure that it is used in such an environment .
Emissions Test
RF Emissions CISPR 11
RF Emissions CISPR 11
Harmonic emissions
IEC/EN 61000-3-2
Voltage fluctuations / flicker
emissions
IEC/EN 61000-3-3
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The 1025DS, 1025KS and 1025UK Oxygen Concentrators are intended for use in the electromagnetic environment specified below. The customer or the user of the
Concentrator should assure that it is used in such an environment .
Immunity Test
Electrostatic discharge (ESD)
IEC 61000-4-2
Radiated RF
IEC 61000-4-3
Conducted RF
IEC 61000-4-6
Electrical fast transient
IEC 61000-4-4
Surge
IEC 61000-4-5
Power frequency magnetic field
IEC 61000-4-8
Voltage dips, short interrupts and
voltage variations on power supply
input lines
IEC 61000-4-11
SE-1025-1
Compliance Electromagnetic Environment – Guidance
The 1025 (series) Oxygen Concentrator uses RF energy only for its internal function . Therefore, its
Group 1 RF emissions are very low and are not likely to cause any interference in nearby electronic
equipment .
Class B
Class B The 1025DS, 1025KS and 1025UK Oxygen Concentrators are suitable for use in all establishments
including domestic and those directly connected to the public low-voltage power supply network
power supply that supplies buildings used for domestic purposes .
Complies
IEC 60601 Test Level Compliance Level
±8kV contact
Complies
±15kV air
10V/m 80MHz to 2 .7GHz &
Proximity fields from RF
Complies
wireless communications
equipment as per section 8 .10
3 Vrms 150kHz to 80MHz
6Vrms ISM Band frequencies Complies
between 150kHz-80MHz
±2kV power line
Complies
±1kV I/O lines
±1kV differential
Complies
±2kV common
30 A/m Complies
100% dip 0 .5 cycle
100% dip 1 cycles
Complies
30% dip 25 cycles
100% dip 5 secs .
Electromagnetic Environment - Guidance
Floors should be wood, concrete, or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30% .
Field strengths outside the shielded location from fixed RF transmitters, as
determined by an electromagnetic site survey, should be less than 3 V/m .
Interference may occur in the vicinity of equipment marked with the
following symbol:
Mains power quality should be that of a typical commercial or hospital
environment .
Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment .
Mains power quality should be that of a typical commercial or hospital
environment . If the user of the Concentrator requires continued operation
during power mains interruptions, it is recommended that the Concentrator
be powered from an uninterruptible power supply or battery .
EN - 11