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Regulatory And Standards Compliance - Philips FM20/30 Instructions For Use Manual

Release j.3 with software revision j.3x.xx patient monitoring.
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Regulatory and Standards Compliance

The fetal monitors are in conformity with the requirements of the European Medical Devices
Directive 93/42/EEC and bear the CE marking:
The fetal monitors are classified into Class IIb according to Annex IX rule 10.
The Avalon CL Transducer System is in conformity with the requirements of the European Radio
Equipment and Telecommunications Terminal Equipment Directive 99/5/EC. The Avalon CL base
station used in this system is class 1 and the Avalon CL transducers of this system are class 1 under the
scope of the R&TTE Directive.
To obtain a copy of the original Declaration of Conformity, please contact Philips at the address given
in the "Manufacturer's Information" on page 280 section of this manual.
Safety and Performance
The fetal monitors comply with the following major international safety and performance standards:
IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010
IEC 60601-1-6:2010 / EN 60601-1-6:2010
IEC 60601-1-8:2006+A1:2012 / EN 60601-1-8:2007+AC:2010
IEC 60601-2-49:2011 / EN 60601-2-49:2001
ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010
CAN/CSA C22.2#60601-1-08
JIS T 1303 2005
AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and software errors was minimized in compliance
with ISO 14971:2012, IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010.
Alarm sounds are compliant with Standard IEC 60601-1-8:2006+A1:2012 /
EN 60601-1-8:2007+AC:2010.
Compatibility
When your fetal monitor is compliant with IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-
1:1990+A1:1993+A2:1995 (Edition 2) and related standards, it can still be used with the Avalon CL
Transducer System and the software upgrade J.3, and all measurement accessories that are compliant
with IEC 60601-1:2005+A1:2012 / EN 60601-1:2006+AC:2010 (Edition 3) and related standards.
When your fetal monitor is compliant with IEC 60601-1:2005+A1:2012 / EN 60601-
1:2006+AC:2010 (Edition 3) and related standards, it can still be used with the Avalon CTS
Transducer System, and all measurement accessories that are compliant with
IEC 60601-1:1988+A1:1991+A2:1995 / EN 60601-1:1990+A1:1993+A2:1995 (Edition 2) and
related standards.
28 Specifications and Standards Compliance
281

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