GE Responder 2000, Руководство по обслуживанию, Страница: 107 / 138

SECTION 8: Specifications and Safety
2025653-048 Revision B Responder
™
2000 Page 107
Safety Standards and Compliance Requirements
The Responder 2000 is designed to meet all applicable requirements of the standards listed below.
IEC 60601-1, (1988 + A1:1991 + A2:1995), Medical Electrical Equipment Part 1 General Requirements for Safety
EN 60601-1, (1990 + A1:1993 + A2:1995), 2
nd
Edition Medical Electrical Equipment, Part 1: General Requirements for
Safety
IEC 60601-1-1, (2000), Medical Electrical Equipment - Part 1: General Requirements for Safety 1: Collateral Standard:
Safety Requirements for Medical Electrical Systems
IEC 60601-2-4, (2002), Medical Electrical Equipment – Part 2-4: Particular Requirements for the Safety of Cardiac
Defibrillators
IEC 60601-2-49, (2001), Medical Electrical Equipment - Part 2-49: Particular Requirements For The Safety Of
Multifunction Patient Monitoring Equipment
IEC 60601-2-27, (1994), Medical electrical equipment, part 2: Particular requirements for the safety of
electrocardiographic monitoring equipment
UL 60601-1, (2003), Medical Electrical Equipment Part 1, General Requirements for safety
CAN/CSA-C22.2 No. 601.1-M90, Medical electrical equipment Part 1: General Requirements for Safety
ANSI/AAMI EC-13-2002, Cardiac monitors, heart rate meters, and alarms
ANSI/AAMI DF80-2003, Medical Electrical Equipment – Part 2-4: Particular Requirements for the Safety of Cardiac
Defibrillators (including automated external defibrillators)
Electromagnetic Compatibility Requirements
The Responder 2000 meets the requirements of the following EMC standards, as required by IEC 60601-2-4.:
IEC 60601-1-2 (2001), Medical electrical equipment Part 1: General requirements for safety 2. Collateral standard:
electromagnetic compatibility - Requirements and tests.
Emissions
Electromagnetic Fields: CISPR 11 (2003), Industrial, scientific and medical (ISM) radio-frequency equipment - radio
disturbance characteristics - limits and methods of measurement; Group 1, Class B. IEC 60601-2-4 (2002), Section
36.201.1.
Harmonic distortion: IEC 61000-3-2 (2004), Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits For Harmonic
Current Emissions (Equipment Input Current Less Than Or Equal To 16 A Per Phase).
Voltage fluctuations and flicker: IEC 61000-3-3 (2002), Electromagnetic Compatibility (EMC) - Part 3-3: Limits - Limitation
Of Voltage Changes, Voltage Fluctuations And Flicker In public Low-Voltage Supply Systems, For Equipment With Rated
Current Less Than Or Equal To 16 A Per Phase.
Immunity
Electromagnetic: IEC 61000-4-3 (2003), Electromagnetic compatibility (EMC) - part 4-3: Testing and measurement
techniques - radiated, radio-frequency, electromagnetic field immunity test; Level 3 (10V/m) and X (20V/m). IEC 60601-2-
4 (2002) Section 36.202.3.
Magnetic: IEC 61000-4-8 (1994), Electromagnetic compatibility (EMC) - part 4. Testing and measurement techniques -
section 8. Power frequency magnetic field immunity test basic EMC publication; Level X (3 A/m). IEC 60601-2-4 (2002),
Section 36.202.8.
ESD: IEC 61000-4-2 (2001), Electromagnetic compatibility (EMC) - part 4-2: testing and measurement techniques -
electrostatic discharge immunity test; Level 3. IEC 60601-2-4 (2002), Section 36.202.2.
Conducted: IEC 61000-4-6 (2003), Electromagnetic compatibility (EMC) - part 4-6: testing and measurement techniques -
immunity to conducted disturbances, induced by radio-frequency fields. IEC 60601-2-4 (2002), Section 36.202.6.