Guidance And Manufacturer's Declaration - DeVilbiss IntelliPAP DV53 STANDARD PLUS CPAP Serie Guía De Instrucciones

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 1
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonics
Class A
IEC 61000-3-2
Flicker
Complies
IEC 61000-3-3
Immunity Test IEC 60601 Test Level
Electrostatic
±6kV contact
Discharge (ESD)
±8kV air
IEC 61000-4-2
Electrical Fast
±2kV on AC Mains
Transient/burst
±1kV for I/O Lines
IEC 61000-4-4
Surge ±1kV Differential
IEC 61000-4-5 ±2kV Common
Voltage dips, short
>95% Dip for 0.5 Cycle
interruptions and
60% Dip for 5 Cycles
voltage variations
on power supply
30% Dip for 25 Cycles
input lines
>95% Dip fo 5 Seconds
IEC 61000-4-11
Power Frequency
50/60Hz Magnetic 3A/m
Field IEC 61000-4-8
Conducted RF 3 Vrms from
IEC 61000-4-6 150 kHz to 80 MHz
A-DV53
Electromagnetic Enforcement – Guidance
This 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.
This device is suitable for use in all establishments including domestic,
and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Compliance Level
±6kV contact
±8kV air
±2kV on AC Mains
±1kV for I/O Lines
±1kV Differential
±2kV Common
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5
Seconds
3A/m
V1 = 3 Vrms
Electromagnetic Environment - Guidance
Floors should be wood, concrete or ceramic
tile. If floors are synthetic, the relative humidity
should be at least 30%.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment. If the
user of this device requires continued
operation during power mains interruptions, it
is recommended that the device be powered
from an uninterruptible power supply or
battery.
Power frequency magnetic fields should be
that of a typical location in a typical
commercial or hospital environment.
Portable and mobile RF communications
equipment should be separated from the
device by no less than the recommended
separation distances calculated/listed below:
D=(1.2)√ P
EN - 15