Alma Lasers Accent xl, Operator'S Manual

Page: 22 / 98

Safety
2.4. Equipment Classification and Compliance
The Accent XL system complies with the following standards:
•
IEC 60601-1-2: Medical electrical equipment: Part 1-2; Collateral
Standard: Electromagnetic compatibility - Requirements
and tests (2001)
•
EN 61000: Electromagnetic compatibility (EMC)
•
EN 61000-3-2: Section 2; Limits for harmonic current emissions
(equipment input current up to and including 16A per
phase) (2000)
•
EN 61000-3-3: Section 3; Limitation of voltage changes, voltage
fluctuations and flicker in public low voltage supply
systems, for equipment with rated current less than 16A per
phase and not subjected for conditional connection
(1995+A1:2001)
•
IEC 61000-4-2: Section 2; Electrostatic discharge immunity tests
(1995 + A1:1998 + A2:2000).
•
IEC 61000-4-3: Section 3; Radiated, radio-frequency, electromagnetic field
immunity test (2002).
•
IEC 61000-4-4: Section 4; Electrical Fast Transient/Burst immunity test
(1995 + A1:2000 + A2:2001).
•
IEC 61000-4-5: Section 5; Surge immunity tests (1995 + A1:2000)
•
IEC 61000-4-6: Section 6; Immunity to conducted disturbances induced by
radio-frequency fields (1996 + A1:2000)
•
IEC 61000-4-8: Section 8: Power frequency magnetic field immunity test
(1993 + A1:2000)
•
IEC 61000-4-11: Section 11: Voltage dips, short interruptions and voltage
variation immunity tests (1994 + A1:2000)
•
EN 55011: Industrial, scientific and medical (ISM) radiofrequency
equipment - Radio disturbance characteristics - Limits and
methods of measurement (1998)
•
IEC 60601-1: Medical electrical equipment. Part 1: General requirements
for safety (1988 + A1:1991 + A2:1995)
In compliance with these standards, the system is equipped with:
•
RF emission indicators
•
RF output displays
•
Emergency shut-off knob
2-8 Accent XL
™
Operator's Manual