Devilbiss Guidance And Manufacturer's Declaration - DeVilbiss Healthcare Vacu-Aide 7314 Serie Guía De Instrucciones

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
interruptions and voltage 60% Dip for 5 Cycles
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.
Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and
this device. This device and system are NOT Life-Supporting
This device is intended for use in the electromagnetic environment in which radiated disturbances are controlled. The customer or user of this device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the device as recommended below,
according to the maximum output power of the communications equipment.
Recommended Separation Distances for the device (meters)
Maximum Output Power
150 kHz to 80 MHz
(Watts)
D=(1.2)
0.01 0.12
0.1 0.38
1 1.2
10 3.8
100 12
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
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 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
3 Vrms
3V/m
80 to 800MHz
P P
D=(1.2)
√ √
0.12
0.38
1.2
3.8
12
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
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
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.
800 MHz to 2.5 GHz
P
D=(2.3)
√
0.23
0.73
2.3
7.3
23
SE-7314-1