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Philips FM20/30 Instructions For Use Manual Page 287

Release j.3 with software revision j.3x.xx patient monitoring.
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Table 2 - Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Immunity Test
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/
60 Hz) magnetic field
IEC 61000-4-8
Key: U
is the AC mains voltage prior to application of the test level.
T
Radio Compliance Notice
Avalon CL with WMTS
Operation of this equipment requires the prior coordination with a frequency coordinator designated
by the FCC for the Wireless Medical Telemetry Service.
This device complies with Part 15 of the FCC Rules and RSS-210 of Industry Canada. Operation is
subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this
device must accept any interference received, including interference that may cause undesired
operation. Any changes or modifications to this equipment not expressly approved by Philips Medical
Systems may cause harmful radio frequency interference and void your authority to operate this
equipment.
Radio Information Canada
Installation of this telemetry device is permitted in hospitals and health care facilities only. This device
shall not be operated in mobile vehicles (including ambulances and other vehicles associated with
health care facilities). The installer/user of this device shall ensure that it is at least 80 km from the
Dominion Radio Astrophysical Observatory (DRAO) near Penticton, British Columbia. The
coordinates of DRAO are: latitude N 49E 19' 15", longitude W 119° 37 12 . For medical telemetry
systems not meeting this 80 km separation (e.g. the Okanagan Valley, British Columbia) the installer/
user must coordinate with, and obtain the written concurrence of, the Director of DRAO before the
equipment can be installed or operated. The Director of DRAO may be contacted at 250-497-2300
(telephone) or 250-497-2355 (fax). (Alternatively, the Manager, Regulatory Standards, Industry Canada,
may be contacted.)
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts
de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) l'appareil ne doit pas produire
IEC 60601-1-2
Compliance Level
Test Level
<5% U
(>95%
<5% U
T
dip in U
) for
for 0.5 cycles
T
0.5 cycles
40% U
(60% dip
40% U
T
in U
) for 5 cycles
5 cycles
T
70% U
70% U
T
(30% dip in U
) for
25 cycles
T
25 cycles
< 5% U
< 5%U
T
(>95% dip in U
)
for 5 sec
T
for 5 sec
3 A/m
3 A/m
28 Specifications and Standards Compliance
Electromagnetic Environment
Guidance
(>95% dip in U
)
Mains power quality should be that of a
T
T
typical commercial and/or hospital
environment. If the user of the device
requires continued operation during
(60% dip in U
) for
T
T
power mains interruptions, it is
recommended that the device is
(30% dip in U
) for
T
T
powered from an uninterruptible power
supply.
(>95% dip in U
)
T
T
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial and/or
hospital environment
287

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