Philips Avalon FM20 - Safety Tests Fetal Monitor - Warnings; Electromagnetic Compatibility (EMC)

12 Specifications
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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.
WARNING
• 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
monitor.
Electromagnetic Compatibility (EMC)
The device and its accessories, listed in the accessories section, comply with the following EMC
standards:
• IEC 60601-1-2:2007 / EN 60601-1-2:2007+AC:2010
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical
equipment. You must operate your monitoring equipment according to the EMC information
provided in this book. Before using the device, assess the electromagnetic compatibility of the device
with surrounding equipment.
This ISM device complies with Canadian ICES-003:2012. Cet appareil ISM est conforme à la norme
NMB-003 du Canada.
CAUTION
• FM20/FM30 only: Although this is an electrical Class II device, it has a protective earth
conductor which is needed for EMC purposes.
• Always use the supplied power cord with the three-prong plug to connect the monitor to AC
mains. Never adapt the three-prong plug from the power supply to fit a two-slot outlet.