2026116-001 Revision B Responder™ 2000 Page 21
SAFETY AND PERFORMANCE STANDARDS
The Responder 2000 has been designed and manufactured to conform to the highest standards of safety and
performance including electromagnetic compatibility (EMC). The Responder 2000 conforms to the applicable
requirements of the following:
CE marked by BSI 0086 per the Medical Device Directive 93/42/EEC of European Union
ETLClassified by ETL Semko with respect to electric shock, fire and mechanical hazards
only in accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, IEC 60601-1 and
IEC 60601-2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard
C22.2 No. 601.1-M90.
Electrical, Construction, Safety and Performance
IEC 60601-1 (1988), Amendments 1 (1991) & 2 (1995)
IEC 60601-2-4 (2002)
ANSI/AAMI DF-80 (2003)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 (2001)
IEC 60601-2-4 (2002) Section 36
ANSI/AAMI DF-80(2003) Section 36
The Responder 2000 needs to be installed and put into service according to the EMC information specified in this manual.
Refer to Section 6 of this manual for a complete list of all Safety Standards.
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