Guidance And Manufacturer's Declaration - DeVilbiss IntelliPAP2 DV63 Standard Plus CPAP Series Instruction Manual

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 – Emissions All Equipment and Systems
This device is intended for use in the electromagnetic environment specified below. The customer or user of this device should assure that it is used in such an environment.
Emissions Test Compliance
RF Emissions
Group 2
CISPR 11
Class B
RF Emissions
Radiated and Conducted
CISPR 11
Emissions
Harmonics IEC 61000-3-2 Class A
Flicker IEC 61000-3-3 Complies
Immunity Test IEC 60601 Test Level
Electrostatic Discharge (ESD) ±8kV contact
IEC 61000-4-2 ±15kV air
Electrical Fast Transient/burst
±2kV on AC Mains
IEC 61000-4-4
±1kV Differential
Surge IEC 61000-4-5
±2kV Common
>95% Dip for 0.5 Cycle
Voltage dips, short
60% Dip for 5 Cycles
interruptions and voltage
variations on power supply 30% Dip for 25 Cycles
input lines IEC 61000-4-11
>95% Dip for 5 Seconds
A-DV64
Electromagnetic Enforcement – Guidance
The DeVilbiss DV63 and DV64 Series CPAP must emit electromagnetic energy in order to perform its intended function.
Nearby electronic equipment may be affected.
The DeVilbiss DV63 and DV64 Series CPAP is suitable for use in all establishments, including domestic establishments
and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic
purposes.
Compliance Level Electromagnetic Environment - Guidance
±8kV contact Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative humidity
±15kV air should be at least 30%.
±2kV on AC Mains Mains power quality should be that of a typical commercial or hospital environment.
±1kV Differential
Mains power quality should be that of a typical commercial or hospital environment.
±2kV Common
>95% Dip for 0.5 Cycle
Mains power quality should be that of a typical commercial or hospital environment. If the
60% Dip for 5 Cycles
user of this device requires continued operation during power mains interruptions, it is
30% Dip for 25 Cycles
recommended that the device be powered from an uninterruptible power supply or battery.
>95% Dip for 5 Seconds
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