Declaration - DeVilbiss DV63 STANDARD PLUS Service Manual

G U I D A N C E & M A N U FA C T U R E R ' S D E C L A R AT I O N
GUIDANCE & MANUFACTURER'S DECLARATION
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. 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
Class A
IEC 61000-3-2
Flicker IEC 61000-3-3 Complies
Immunity Test IEC 60601 Test Level
Electrostatic Discharge
±8kV contact
(ESD)
±15kV air
IEC 61000-4-2
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
interruptions and voltage
60% Dip for 5 Cycles
variations on power
30% Dip for 25 Cycles
supply input lines IEC
>95% Dip for 5 Seconds
61000-4-11
Power Frequency
50/60Hz Magnetic Field 30 A/m
IEC 61000-4-8
Conducted RF 3 Vrms from
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 10 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.
LT-2320
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
±15kV air relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital
±2kV on AC Mains
environment.
±1kV Differential Mains power quality should be that of a typical commercial or hospital
±2kV Common environment.
>95% Dip for 0.5 Cycle
Mains power quality should be that of a typical commercial or hospital
60% Dip for 5 Cycles
environment. If the user of this device requires continued operation during
30% Dip for 25 Cycles
power mains interruptions, it is recommended that the device be powered
>95% Dip for 5 Seconds from an uninterruptible power supply or battery.
Power frequency magnetic fields should be that of a typical location in a
30 A/m
typical commercial or hospital environment.
Portable and mobile RF communications equipment should be separated
V1 = 3 Vrms
from the device by no less than the recommended separation distances
6 Vrms on ISM & Amateur
calculated/listed below:
Bands
D=(0.4)√ P
D=(0.4)√ P
D=(0.7)√ P
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
E1 = 10 V/m
site survey, should be less than the compliance levels (V1 and E1).
Interference may occur in the vicinity of equipment marked with the following
symbol:
36
80 to 800 MHz
800 MHz to 2.5 GHz