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ALLY II UPS™
SECTION 13 GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC EMISSIONS
(for all Medical Equipment and Medical Equipment Systems)
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.
EMISSIONS TEST
COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE
RF emissions CISPR 11
Group 1
The ALLY II UPS™ uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emissions CISPR 11
Class A
The ALLY II UPS™ is suitable for use in all
establishments other than domestic and those directly
connected to the public low voltage power supply network
that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2
Class A
Voltage fluctuations/flicker emissions
IEC 61000-3-3
Complies
SECTION 14 GUIDANCE AND MANUFACTURER’S DECLARATION –
ELECTROMAGNETIC IMMUNITY
(for all Medical Equipment and Medical Equipment Systems)
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 OR TEST
METHOD
IMMUNITY TEST LEVELS
PROFESSIONAL HEALTHCARE
FACILITY ENVIRONMENT
HOME HEALTHCARE
ENVIRONMENT
Electrostatic discharge
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
Radiated RF EM fields
a)
IEC 61000-4-3
3 V/m
f)
80 MHz - 2,7 GHz
b)
80 % AM at 1 kHz
c)
10 V/m
f)
80 MHz - 2,7 GHz
b)
80 % AM at 1 kHz
c)
Proximity fields from RF wireless
communications equipment
IEC 61000-4-3
See 8.10 IEC 60601-1-2
Rated power frequency magnetic fields
d) e)
IEC 61000-4-8
30 A/m
g)
50 Hz or 60 Hz
a)
The interface between the patient physiological signal simulation, if used, and the ME equipment or ME system shall be located within 0,1 m of
the vertical plane of the uniform field area in one orientation of the ME equipment or ME system.
b)
ME equipment and ME systems that intentionally receive RF electromagnetic energy for the purpose of their operation shall be tested at the
frequency of reception. Testing may be performed at other modulation frequencies identified by the risk management process. This test assesses
the basic safety and essential performance of an intentional receiver when an ambient signal is in the passband. It is understood that the receiver
might not achieve normal reception during the test.
c)
Testing may be performed at other modulation frequencies identified by the risk management process.
d)
Applies only to ME equipment and ME systems with magnetically sensitive components or circuitry.
e)
During the test, the ME equipment or ME system may be powered at any nominal input voltage, but with the same frequency as the test signal
(
see Table 1 in IEC 60601-1-2
).
f)
Before modulation is applied.
g)
This test level assumes a minimum distance between the ME equipment or ME system and sources of power frequency magnetic field of
at least 15 cm. If the risk analysis shows that the ME equipment or ME system will be used closer than 15 cm to sources of power frequency
magnetic field, the immunity test level shall be adjusted as appropriate for the minimum expected distance.
