1: GSN Introduction
23
Geodesic Sensor Net Technical Manual
S-MAN-200-GSNR-001 • January 31, 2007
Regulatory Compliance
•
Certification
: This medical equipment is certified to EN 60601-1, CSA 22.2
No. 601.1, CSA 22.2 No. 601.2.26, UL 2601, and IEC 60601-2.26. The Geodesic
EEG System, of which the GSN is a part, carries the U.S. FDA Pre-market 510k
Clearance, Canadian Medical Device License (Homologation d’un instrument
medical), European CE Certification, and Japanese Yakuji Approval.
•
Applied Part
: Type BF
•
GSN 200
: Electrical Class I Equipment
Symbols
Table 1-2 describes the labels and symbols used on the equipment.
Table 1-2. GSN symbols
Symbol Description Symbol Description
Subject-connected part Protective earth ground point
Labeled component is
certified to CSA 601-2-26
and UL 2601 and IEC 60601-
See accompanying
documents.
Mark indicating that the
product is CE compliant. The
number 0366 is the EC
reference number of the VDE
Testing and Certification
Institute, the notified body for
Electrical Geodesics, Inc.
0366
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