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Philips FM20/30 Instructions For Use Manual Page 282

Release j.3 with software revision j.3x.xx patient monitoring.
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28 Specifications and Standards Compliance
The Avalon CL Transducer System complies with the following major international radio standards:
ETSI EN 300 220-1:2012
ETSI EN 300 220-2:2012
ETSI EN 301 489-1:2011
ETSI EN 301 489-3:2003
FCC 47 CFR Part 95
IC RSS-210 Issue 8
ETSI EN 300 328:2006
ETSI EN 301 489-17:2009
FCC 47 CFR Part 2 & 15
AS/NSZ 4268
AS/NSZ 4771:2000+A1:2003
Safety Tests Fetal Monitor
All the safety tests and procedures required after an installation, or an exchange of system components
are described in your monitor's Service Guide. These safety tests are derived from international
standards, but may not be sufficient to meet local requirements.
Do not use additional AC mains extension cords or multiple portable socket-outlets. If a multiple
portable socket-outlet is used, the resulting system must be compliant with IEC 60601-
1:2005+A1:2012 / EN 60601-1:2006+AC:2010.
Do not connect any devices that are not supported as part of a system.
Do not use a device in the patient vicinity if it does not comply with IEC 60601-
1:2005+A1:2012 / EN 60601-1:2006+AC:2010. The whole installation, including devices outside
of the patient vicinity, must comply with IEC 60601-1:2005+A1:2012 /
EN 60601-1:2006+AC:2010. Any non-medical device, including a PC running an OB TraceVue/
IntelliSpace Perinatal system, placed and operated in the patient's vicinity must be powered via a
separating transformer (compliant with IEC 60601-1:2005+A1:2012 /
EN 60601-1:2006+AC:2010) that ensures mechanical fixing of the power cords and covering of
any unused power outlets.
Do not use USB devices with own power supplies, unless an appropriate separation device is used,
(either between USB interface and device or between device and power).
During the installation the fetal monitor is configured for your environment. This configuration
defines your custom default settings you work with when you switch on your fetal monitor. See the
fetal monitor's Service Guide and the Configuration Guide for details on how to configure your fetal


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Avalon clFm40/50

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