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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 conguration 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 specied below. The customer or the user of the
Concentrator should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment – Guidance
RF Emissions CISPR 11 Group 1
The 1025 (series) Oxygen Concentrator 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 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.
Harmonic emissions
IEC/EN 61000-3-2
Class B
Voltage uctuations / icker
emissions
IEC/EN 61000-3-3
Complies
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The 1025DS, 1025KS and 1025UK Oxygen Concentrators are intended for use in the electromagnetic environment specied below. The customer or the user of the
Concentrator should assure that it is used in such an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8kV contact
±15kV air
Complies
Floors should be wood, concrete, or ceramic tile. If oors are covered with
synthetic material, the relative humidity should be at least 30%.
Radiated RF
IEC 61000-4-3
10V/m 80MHz to 2.7GHz &
Proximity elds from RF
wireless communications
equipment as per section 8.10
Complies
Field strengths outside the shielded location from xed 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:
Conducted RF
IEC 61000-4-6
3 Vrms 150kHz to 80MHz
6Vrms ISM Band frequencies
between 150kHz-80MHz
Complies
Electrical fast transient
IEC 61000-4-4
±2kV power line
±1kV I/O lines
Complies
Mains power quality should be that of a typical commercial or hospital
environment.
Surge
IEC 61000-4-5
±1kV differential
±2kV common
Complies
Power frequency magnetic eld
IEC 61000-4-8
30 A/m Complies
Power frequency magnetic elds should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
Voltage dips, short interrupts and
voltage variations on power supply
input lines
IEC 61000-4-11
100% dip 0.5 cycle
100% dip 1 cycles
30% dip 25 cycles
100% dip 5 secs.
Complies
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.
A-1025
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