Devilbiss Guidance And Manufacturer's Declaration - DeVilbiss Vacu-Aide QSU 7314 Série Manuel Utilisateur

manufacturer's Note
Thank you for choosing a DeVilbiss Suction Unit. We want you to be a satisfied customer. If you have any questions or comments, please send them to our address on the
back cover.
For Service Call Your Authorized DeVilbiss Healthcare Provider:
Phone

DEVIlbISS GUIDANcE AND mANUFActURER'S DEclARAtION

wARNING
Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according
to the 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 CISPR 11 Group 1
Class B Radiated and
RF Emissions CISPR 11
Conducted Emissions
Harmonics IEC 61000-3-2 Class A
Flicker IEC 61000-3-3 Complies
Immunity Test IEC 60601 Test Level
Electrostatic Discharge ±6kV contact
(ESD) IEC 61000-4-2 ±8kV air
Electrical Fast Transient/
±2kV on AC Mains
burst IEC 61000-4-4
Surge ±1kV Differential
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
Power Frequency 50/60Hz
Magnetic Field 3A/m
IEC 61000-4-8
Conducted RF 3 Vrms from
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m
IEC 61000-4-3 80 MHz to 2.5 GHz
For transmitters rated at a maximum output power not listed above, the recommended separation distance D in meters (m) can be estimated using the equation applicable
to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.
EN - 10
Purchase Date
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 Electromagnetic Environment - Guidance
±6kV contact Floors should be wood, concrete or ceramic tile. If floors are synthetic, the relative
±8kV air humidity 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.
60% Dip for 5 Cycles
If the user of this device requires continued operation during power mains
interruptions, it is recommended that the device be powered from an uninterruptible
30% Dip for 25 Cycles
power supply or battery.
>95% Dip for 5 Seconds
Power frequency magnetic fields should be that of a typical location in a typical
3A/m
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
3 Vrms below:
D=(1.2)
D=(1.2)√ P 80 to 800 MHz
D=(2.3)√ P 800 MHz to 2.5 GHz
Where P is the maximum power rating in watts and D is the recommended
3V/m
separation distance in meters.
Field strengths from fixed transmitters, as determined by an electromagnetic site
survey, should be less than the compliance levels (3 Vrms and 3V/m).
Interference may occur in the vicinity of equipment containing a transmitter.
Serial #
√ P
A-7314