biodex SYSTEM 4 - Product Certifications and Classifications; Authorized European Community Representative

6
Product Certifications and Classifications
This product has received the following certifications and falls within the following
classifications:
 IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 (or IEC
60601-1: 2012 reprint)
 ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010.
 CAN/CSA C22.2 No. 60601-1:14
 FDA Class II Equipment
 Type B Applied Part
 Electromagnetic Compatibility: This equipment complies with the Medical Equipment IEC
60601-1-2:2014 EMC Standard.
NOTE: Component part lists, descriptions, calibration instructions, or other
information used to assist service personnel to repair those parts of the equipment
that are designated as repairable for this product are provided on the Biodex website,
www.biodex.com or can be obtained by contacting Biodex Customer Service (see
Contact information).
NOTE: Complete information on the Electromagnetic Compatibility for the System 4 can be
located in the Compliance Supplement located on the Biodex website (www.biodex.com) or can
be obtained by contacting Biodex Customer Service (see Contact information).
Authorized European Community Representative:
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands