Philips Avalon FM20, Service Manual

Page: 240 / 260

12 Specifications
240
Manufacturer's Information
You can write to Philips at this address:
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Visit our website for local contact information at: www.healthcare.philips.com
© Copyright 2014. Koninklijke Philips N.V. All Rights Reserved.
Trademark Acknowledgment
Oxisensor
TM
II , Oxi-Cliq
TM
, and OxiMax
TM
are trademarks of Tyco Healthcare Group LP, Nellcor
Puritan Bennett Division.
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 240 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
Special wave, with different speed and scale (for example, fast printout of MECG wave on
FM30)
Recorder Symbols
Symbol Description