Safety And Performance Standards - GE AED Pro Service Manual

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SAFETY AND PERFORMANCE STANDARDS

AED MODEL 2023440
The AED has been designed and manufactured to conform to the highest standards of safety and performance including
electromagnetic compatibility (EMC). The Responder AED Pro Model 2023440 and pads conform to the applicable
requirements of the following:
Electrical, Construction, Safety and Performance
IEC 60601-1 (1998), Amendments 1 (1991) & 2 (1995)
IEC 60601-2-4 (2002)
IEC 60601-1-4 (2000)
ANSI/AAMI DF-39 (1993)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 (2001)
IEC 60601-2-4 Section 36
ANSI/AAMI DF-39(1993) Section 3.3.21
The unit is safe for human use in compliance with the IEC 60601-1 Safety Analysis Tests standard.
EMMISIONS
Field
E-M
Magnetic
IMMUNITY
Field
E-M
Magnetic
ESD
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CE
CE Marked by BSI 0086 per the Medical Device Directive 93/42/EEC of European Union
ETL
Classified 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, EN60601-1 and
EN60601-2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard
C22.2 No. 601.1-M90.
Standard or Compliance
IEC 55011/CISPR 11, Group 1, Class B
ANSI/AAMI DF39, <0.5mT on surface, except for within 5cm of
the lid magnet and the speaker
Standard or Compliance
IEC 61000-4-3, Level X, (20V/m)
IEC 60601-2-4, Section 36.202.3 (20-V/m)
AAMI DF39, Section 3.3.21.2.1
IEC 61000-4-8 (2001)
IEC 60601-2-4 (2002), Section 36.202.8
AAMI DF39, Section 3.3.21.2.3 80A/m, 47.5Hz – 1,320Hz
IEC 61000-4-2, Level 3
IEC 60601-2-4 (2002), Section 36.202.2
6KV contact discharge, 8KV air gap discharge
© 2007 General Electric Company 2023491-201 Rev B