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COMPLIANCE AND IEC CLASSIFICATION
12
COMPLIANCE AND IEC CLASSIFICATION
12
IEC COMPLIANCE:
EN/IEC 60601-1-2 4th edition: 2014 (Medical electrical equipment Part 1-2: General
requirements for basic safety and essential requirements - Collateral standard: Electromagnetic disturbances
- Requirements and tests) defines the RF emissions limits and minimum RF immunity requirements for different
types of medical electrical equipment. The following tables include the RF emissions limits and RF immunity
requirements for, and results of tests upon, the Life2000® Ventilation System.
The Life2000® Ventilation System requires special precautions regarding electromagnetic compatibility (EMC) and
needs to be installed and put into service according to the EMC information provided in this
Instructions for Use
.
The use of accessories or cables other than those specified may result in increased emissions or decreased
immunity of the Life2000® Ventilation System.
GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC EMISSIONS
The Life2000® Ventilation System is intended for use in the electromagnetic environment specified below. The
customer or user of the ventilation system should ensure that it is used in such an environment.
Emission Test
Compliance
Electromagnetic Environment - Guidance
RF emissions CISPR 11
Group 1
The Life2000® Ventilation System RF emissions are within
CISPR 11 guidelines and are not likely to cause interference
in nearby electronic equipment.
RF emissions CISPR 11
Class B
The Life2000® Ventilation System is suitable for use in
all establishments, including domestic establishments
and those directly connected to the public power supply
network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Complies
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
GUIDANCE AND MANUFACTURER’S DECLARATION: ELECTROMAGNETIC IMMUNITY
The Life2000® Ventilation System is intended for use in the electromagnetic environment specified below. The
customer or user of the ventilation system should ensure that it is used in such an environment.
Immunity Test
IEC 60601
Requirement
Compliance
Level
Electromagnetic
Environment - Guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
Electrical fast
Transient/burst IEC
61000-4-4
±2 kV for power
supply lines
±1 kV for input/output
lines
±2 kV for power supply
lines
Not applicable
Mains power quality should be that of a typical
household or hospital environment.
Surge IEC 61000-4-5 ±1 kV line(s) to line(s)
±2 kV line(s) to earth
±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be that of a typical
household or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-111
0% U
T
(95% dip in U
T
for 0.5 cycle)
0% U
T
; 0.5 cycle, at 0°, 45°,
90°, 135°, 180°, 225°, 270°,
and 315°
Mains power quality should be that of a typical
household or hospital environment.
0% U
T
; 1 cycle
0% U
T
; 1 cycle
70% U
T
(30% dip in
U
T
for 25 cycles)
70% U
T
; 25/30 cycles
0% U
T
for 5 seconds 0% U
T
; 250/300 cycles
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
30 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical household or hospital environment.
