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ALLY II UPS™
SECTION 15 GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
(for all Medical Equipment and Medical Equipment Systems that are not
Life-Supporting)
The ALLY II UPS™ is intended for use in the electromagnetic environment specified below. The customer or the user
of the ALLY II UPS™ should assure that it is used in such an environment.
PHENOMENON
BASIC EMC
STANDARD
IMMUNITY TEST LEVELS
PROFESSIONAL HEALTHCARE
FACILITY ENVIRONMENT
HOME HEALTHCARE
ENVIRONMENT
Electrical fast transients /
bursts
a) l) o)
IEC 61000-4-4
± 2 kV
100kHz repetition frequency
Surges
a) b) j) o)
Line-to-line
IEC 61000-4-5
± 0,5 kV, ± 1 kV
Surges
a) b) j) k) o)
Line-to-ground
IEC 61000-4-5
± 0,5 kV, ± 1 kV, ± 2 kV
Conducted disturbances
induced by RF fields
c) d) o)
IEC 61000-4-6
3 V
m)
0,15 MHz - 80 MHz
6 V
m)
in ISM bands between 0,15 MHz
and 80 MHz
n)
80 % AM at 1 kHz
e)
3 V
m)
0,15 MHz - 80 MHz
6 V
m)
in ISM and amateur
radio bands between
0,15 MHz and 80 MHz
n)
80 % AM at 1 kHz
e)
Voltage dips
f) p) r)
IEC 61000-4-11
0 %
U
T
; 0,5 cycle
g)
At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
q)
0 %
U
T
; 1 cycle
and
70 %
U
T
; 25/30 cycles
h)
Single phase: at 0º
Voltage interruptions
f) i) o) r)
IEC 61000-4-11 0 %
U
T
; 250/300 cycle
h)
a)
The test may be performed at any one power input voltage within the ME equipment or ME system rated voltage range. If the ME equipment or
ME system is tested at one power input voltage, it is not necessary to re-test at additional voltages.
b)
All ME equipment and ME system cables are attached during the test.
c)
Calibration for current injection clamps shall be performed in a 150 Ω system.
d)
If the frequency stepping skips over an ISM or amateur band, as applicable, an additional test frequency shall be used in the ISM or amateur
radio band. This applies to each ISM and amateur radio band within the specified frequency range.
e)
Testing may be performed at other modulation frequencies identified by the risk management process.
f)
ME equipment and ME systems with a d.c. power input intended for use with a.c.-to-d.c. converters shall be tested using a converter that meets the
specifications of the manufacturer of the ME equipment or ME system. The immunity test levels are applied to the a.c. power input of the converter.
g)
Applicable only to ME equipment and ME systems connected to single-phase a.c. mains.
h)
E.g. 10/12 means 10 periods at 50 Hz or 12 periods at 60 Hz.
i)
ME equipment and ME systems with rated input current greater than 16 A / phase shall be interrupted once for 250/300 cycles at any angle and
at all phases at the same time (if applicable). ME equipment and ME systems with battery backup shall resume line power operation after the test.
For ME equipment and ME systems with rated input current not exceeding 16 A, all phases shall be interrupted simultaneously.
j)
ME equipment and ME systems that do not have a surge protection device in the primary power circuit may be tested only at ± 2 kV line(s) to
earth and ± 1 kV line
k)
Not applicable to Class II ME equipment and ME systems.
l)
Direct coupling shall be used.
m)
r.m.s., before modulation is applied.
n)
The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz;
26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5
MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to
21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
o)
Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A / phase and ME equipment and ME systems with
rated input current greater than 16 A / phase.
p)
Applicable to ME equipment and ME systems with rated input current less than or equal to 16 A / phase.
q)
At some phase angles, applying this test to ME equipment with transformer mains power input might cause an overcurrent protection device to
open. This can occur due to magnetic flux saturation of the transformer core after the voltage dip. If this occurs, the ME equipment or ME system
shall provide basic safety during and after the test.
r)
For ME equipment and ME systems that have multiple voltage settings or auto ranging voltage capability, the test shall be performed at the
minimum and maximum rated input voltage. ME equipment and ME systems with a rated input voltage range of less than 25 % of the highest rated
input voltage shall be tested at one rated input voltage within the range. See Table 1 Note c) in IEC 60601-1-2 for examples calculations.
