Regulatory Compliance; Symbols; Gsn Symbols - Geodesic Sensor Net Technical Manual

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.
Symbol
0366
Geodesic Sensor Net Technical Manual
Table 1-2. GSN symbols
Description
Subject-connected part
Labeled component is
certified to CSA 601-2-26
and UL 2601 and IEC 60601-
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.
S-MAN-200-GSNR-001 • January 31, 2007
Symbol Description
Protective earth ground point
See accompanying
documents.
1: GSN Introduction
23