first years Breastflow Memory Pump Manuel D'instructions page 12

Memory Pump
Appendix A: Documentation, Labelling and Markings Compliance Summary
Table 1:
Guidance and manufacturer's declaration - electromagnetic emissions
The unit is intended for use in the electromagnetic environment speci ed below.
The customer or the user of the unit should assure that it is used in such an environment.
Emissions test Compliance
RF emissions The unit uses RF energy only for its internal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment.
The unit is suitable for use in all establishments, other than domestic establishments and
RF Emissions
Class B those directly connected to the public low-voltage power supply network that supplies
CISPR 11
buildings used for domestic purposes.
Harmonic emissions
Class A
IEC 61000-3-2
Voltage uctuations/ icker
Class A
emissions IEC 61000-3-3
Table 2:
Guidance and manufacturer's declaration – electromagnetic immunity
The unit is intended for use in the electromagnet environment speci ed below. The customer
or the end user of the unit should assure that it is used in such an environment.
EC 60601
Immunity test
Test level
Electromagnetic discharge +6 kV contact
(ESD) IEC 61000-4-2
+8 kV air
Electrical fast
+2 kV for power supply lines +2 kV for power supply lines
transient/burst
+1 kV for input/output lines
+1 kV for input/output lines
IEC 61000-4-4
+1 kV di erential mode
Surge
IEC 61000-4-5 +2 kV common mode
<5 % UT (>95 % dip in UT)
for 0.5 cycle
Voltage dips, short
40 % UT (60 % dip in UT)
interruptions and
for 5 cycles
voltage variations on
70 % UT (30 % dip in UT)
power supply input lines
for 25 cycles
IEC 61000-4-11
<5 % UT (>95 % dip in UT)
for 5 sec
Power frequency
(50/60 Hz) magnetic eld 3 A/m
IEC 61000-4-8
22 get ready for thefirstyears.com TM
Electromagnetic environment – guidance
Not Applicable
Not Applicable
Compliance level Electromagnetic environment - guidance
Floors should be wood, concrete or ceramic tile. If oors
+6 kV contact
are covered with synthetic material, the relative
+8 kV air
humidity should be at least 30 %.
Mains power quality should be that of a typical
commercial or hospital environment.
+1 kV di erential mode Mains power quality should be that of a typical
+2 kV common mode commercial or hospital environment.
<5 % UT (>95 % dip in UT)
for 0.5 cycle Mains power quality should be that of a typical
commercial or hospital environment. If the user
40 % UT (60 % dip in UT)
for 5 cycles of the unit requires continued operation during
power mains interruptions, it is recommended
70 % UT (30 % dip in UT)
for 25 cycles
that the unit be powered from an
<5 % UT (>95 % dip in UT)
uninterruptible power supply or a battery.
for 5 sec
Power frequency magnetic elds should be at
3 A/m levels characteristic of a typical location in a
typical commercial or hospital environment.
Table 6:
Guidance and manufacturer's declaration - electromagnetic emissions
The unit is intended for use in the electromagnetic environment speci ed below. The customer or the
user of the unit should assure that it is used in such an environment.
IEC 60601
Immunity test Compliance Level
Test level
Radiated RF 3 V/m
IEC 61000-4-3
80MHz to 2.5 GHz
3 V/m
Conducted RF
3 Vrms
IEC 61000-4-6 150 kHz to 80 MHz
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is a ected by absorption and re ection from
structures, objects and people.
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured
eld strength in the location in which the unit is used exceeds the applicable RF compliance level above, the unit should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the Model
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the unit
including cables, than the Recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
d = 1.7 √ P 80 MHz to 800 MHz
√
d = 2.3 P 800 MHz to 2.5 GHz
d = [3.5/V1] √ P
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m).
Field strengths from xed RF transmitters, as determined
by an electromagnetic site survey, should be less than
the compliance level in each frequency range.
Interference may occur in the vicinity of equipment
marked with the following symbol:
get ready for thefirstyears.com 23
TM