DeVilbiss AUTOADJUST DV64, Руководство по обслуживанию

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LT-2320
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G U I DA 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 Electromagnetic Enforcement – Guidance
RF Emissions
CISPR 11
Group 2
The DeVilbiss DV63 and DV64 Series CPAP must emit electromagnetic energy in order to perform its
intended function. Nearby electronic equipment may be affected.
RF Emissions
CISPR 11
Class B
Radiated and Conducted
Emissions
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.
Harmonics
IEC 61000-3-2
Class A
Flicker IEC 61000-3-3 Complies
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment - Guidance
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood, concrete or ceramic tile. If floors are synthetic, the
relative humidity should be at least 30%.
Electrical Fast Transient/
burst
IEC 61000-4-4
±2kV on AC Mains ±2kV on AC Mains
Mains power quality should be that of a typical commercial or hospital
environment.
Surge IEC 61000-4-5
±1kV Differential
±2kV Common
±1kV Differential
±2kV Common
Mains power quality should be that of a typical commercial or hospital
environment.
Voltage dips, short
interruptions and voltage
variations on power
supply input lines IEC
61000-4-11
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
>95% Dip for 0.5 Cycle
60% Dip for 5 Cycles
30% Dip for 25 Cycles
>95% Dip for 5 Seconds
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
50/60Hz Magnetic Field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields should be that of a typical location in a
typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6
3 Vrms from
150 kHz to 80 MHz
V1 = 3 Vrms
6 Vrms on ISM & Amateur
Bands
Portable and mobile RF communications equipment should be separated
from the device by no less than the recommended separation distances
calculated/listed below:
D=(0.4)
√
P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5 GHz
E1 = 10 V/m
D=(0.4)
√
P 80 to 800 MHz
D=(0.7)
√
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 (V1 and E1).
Interference may occur in the vicinity of equipment marked with the following
symbol:
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.