HP_4E2-INS-LAB-RevA21 28
9 APPENDIX
9.1 GUIDANCE AND MANUFACTURER’S DECLARATION —
ELECTROMAGNETIC EMISSIONS
The Hausted Stretchers are intended for use in the electromagnetic environment specified below. The customer or
the user of the Hausted Stretchers should assure that they are used in such an environment.
Emissions Test
Compliance Electromagnetic Environment — Guidance
RF emissions
CISPR 11
Group 1
The Hausted Stretchers use RF energy only for their
internal function. Therefore, their RF emissions are
very low and are not likely to cause any interference in
nearby electronic equipment.
The Hausted Stretchers are 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.
RF emissions
CISPR 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Complies
9.2 ENCLOSURE PORT
1
Phenomenon
Basic EMC
standard or test
method
I
MMUNITY TEST LEVELS
Professional healthcare facility environment
E
LECTROSTATIC
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)
Proximity fields from RF
wireless
communications
equipment
IEC 61000-4-3
See Table 9.3.
R
ATED
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)
M
E 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).
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.
