Hillrom Breathe LIFE2000, Инструкция по эксплуатации

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COMPLIANCE AND IEC CLASSIFICATION 12 COMPLIANCE AND IEC CLASSIFICATION 12
GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY
The Life2000® Ventilation System is intended for use in the electromagnetic environment specified below. The
customer or user of the ventilation system should ensure that it is used in such an environment.
LIFE2000® VENTILATION SYSTEM
Immunity Test IEC 60601
Requirement Compliance Level Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz,
6 Vrms in ISM and
amateur radio band
between 0.15 MHz
and 80 MHz, 80%
modulation at 1 KHz
3 Vrms
150 kHz to 80 MHz,
6 Vrms in ISM and
amateur radio band
between 0.15 MHz
and 80 MHz, 80%
modulation at 1 KHz
Portable and mobile RF communications equipment
should be used no closer to any part of the Life2000®
Ventilation System, including cables, than the
recommended separations distance calculated from the
equation applicable to the frequency of the transmitter.²
Recommended separation distance:³
d = 1.17 √P 150 kHz to 80MHz
d = 0.35 √P 80 MHz to 800 MHz³
d = 0.70 √P 800 MHz to 2.5GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from fixed RF transmitters, as determined
by an electromagnetic site survey* should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of equipment marked
with the following symbol:
Radiated RF
IEC 61000-4-3
Shall withstand
test frequencies,
amplitudes, and
conditions specified
in Table 9 of IEC
60601-1-2 (4th ed.)
Tested to
frequencies,
amplitudes, and
conditions specified
in Table 9 of IEC
60601-1-2 (4th ed.)
NOTE 1: U
T
is the AC mains voltage prior to application of the test level.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
NOTE 3: At 80 MHz and 800 MHz, the higher frequency range applies.
* Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TB broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be
considered. If the measured field strength in the location in which the ventilation system is used exceeds the applicable RF
compliance level above, the ventilation system should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the ventilation system.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATION
EQUIPMENT AND THE LIFE2000® VENTILATION SYSTEM
The Life2000® Ventilation System is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The clinician can help prevent electromagnetic interferences by maintaining a
minimum distance between portable and mobile RF communications equipment (transmitters) and the ventilation
system as recommended in this table, according to the maximum output power of the communications
equipment.¹
Rated maximum output
power of transmitter (W) Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
d = 1.17 √P
80 MHz to 800 MHz ²
d = 0.35 √P 800 MHz to 2.5 GHz
d = 0.7 √P
0.01 0.17 0.035 0.070
0.1 0.37 0.11 0.22
1 1.17 0.35 0.70
10 3.69 1.1 2.2
100 11.70 3.5 7.0
NOTE 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
NOTE 2: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
For transmitters rated at a maximum output power not listed above, the recommended separations distance (d) in
meters (m) can be estimated using the equations given in the table above 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.