Table 1 – Guidance and Manufacture’s declaration – Electromagnetic Emissions –
for all ME Equipment and ME Systems
Guidance and manufacturer’s declaration – electromagnetic emissions
The Controller, VADPAK, SmartPak batteries and HeartAttendant are intended for use in the
electromagnetic environment specified below. The customer or the user of these components should
assure that they are used in such an environment.
These components use RF
RF emissions
energy only for their internal
Group 1
functions. Therefore, RF
CISPR 11
emissions are very low and are
not likely to cause any
interference in nearby electronic
equipment.
RF emissions
Class B
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
These components are suitable
for use in all establishments,
including domestic
establishments and those directly
connected to the public lowvoltage power supply network
that supplies buildings used for
domestic purposes.
Table 2 – Guidance and Manufacturer’s declaration – Electromagnetic Immunity –
for ALL ME Equipment and ME Systems
Guidance and manufacturer’s declaration – electromagnetic immunity
The Controller, VADPAK, SmartPak batteries and HeartAttendant are intended for use in the
electromagnetic environment specified below. The customer or the user of these components should
assure that they are used in such an environment.
Immunity Test
IEC 60601
Compliance level
Electromagnetic
test level
environment guidance
Electrostatic discharge
± 6 kV contact
± 6 kV contact
Floors should be wood,
(ESD)
concrete or ceramic tile.
± 8 kV air
± 8 kV air
If floors are covered
IEC 61000-4-2
with synthetic material,
the relative humidity
should be at least 30%.
Electrical fast
± 2 kV for power supply
±2 kV for power
Mains power quality
transient/burst
lines
supply lines
should be that of a
typical commercial or
IEC 61000-4-4
± 1 kV for input/output
±1 kV for input/
hospital environment.
lines
output lines
Surge
± 1 kV line(s) to line(s)
±1 kV differential
Mains power quality
Mode
should be that of a
IEC 61000-4-5
typical commercial or
± 2 kV line(s) to earth
±2 kV common
hospital environment.
mode
< 5% UT
<5% UT
Voltage dips, short
Mains power quality
(>95 % dip in UT )
(>95% dip in UT)
interruptions and
should be that of a
voltage variations on
For 0.5 cycle
for 0.5 cycle
typical commercial or
power supply input lines
hospital environment. If
40 % UT
40% UT
the user of this
( 60 % dip in UT )
(60% dip in UT)
IEC 61000-4-11
equipment requires
for 5 cycles
for 5 cycles
continued operation
during power mains
70 % UT
70% UT
interruptions, it is
(30 % dip in UT )
(30% dip in UT)
recommended that this
for 25 cycles
equipment be powered
from an uninterruptible
<5 % UT
<5% UT
power supply or a
(>95 % dip in UT)
(>95% dip in UT)
battery.
For 5 s
for 5 sec
Power frequency (50/60
Power frequency
Hz) magnetic filed
magnetic fields should
10 A/m
10 A/m
be at levels
IEC 61000-4-8
characteristic of a
60 A/m
typical location in a
typical commercial or
hospital environment.
NOTE
UT is the a. c. Mains voltage prior to application of the test level.
Table 3 – Guidance and Manufacturer’s declaration – Electromagnetic Immunity –
for LIFE-SUPPORTING ME Equipment and ME Systems
Guidance and Manufacturer’s declaration – Electromagnetic Immunity
The Controller, VADPAK and SmartPak Batteries are intended for use in the electromagnetic environment specified
below. The customer or the user of this equipment should assure that it is used in such an environment.
Immunity Test
IEC 60601Test
Compliance Level
Electromagnetic Environment - Guidance
Level
Portable and mobile RF communications
equipment should be used no closer to any
part of this equipment, including cables,
than the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.
Recommended separation distance
3.5
Conducted RF
3 Vrms
3V
𝑑 = [ 3 ]√𝑃
IEC 61000-4-6
150 kHz to 80
MHz
Outside ISM
bandsa
12
10 Vrms
150 kHz to 80
MHz in ISM
bandsa
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2.5
GHz
10 V
𝑑 = [10]√𝑃
12
𝑑 = [10]√𝑃
23
10 V/m
𝑑 = [10]√𝑃
80 MHz to 800 MHz
800 MHz to 2.5 GHz
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). b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
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 affected by absorption and reflection form structures, objects and people.
a
The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 27,957 MHz to 27,283
MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150 kHz an d80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been
incorporated into the formula used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which this equipment is used exceeds the applicable RF compliance level above, this equipment should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating this equipment.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.
Table 5 – Recommended separation distance between portable and mobile RF
communications equipment and the ME Equipment or ME System –
for LIFE-SUPPORTING ME Equipment and ME Systems
Recommended separation distances between portable and mobile RF communications equipment and the
Controller, VADPAK and Smart Batteries
This equipment is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of this equipment can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile communications equipment (transmitters) and this equipment as recommended
below, according to the maximum output power of the communications equipment.
Rated maximum output
Separation distance according to frequency of transmitter
power of transmitter
m
W
150 kHz to 80
150 kHz to 80
80 MHz to 800
800 MHz to 2.5 GHz
MHz outside ISM
MHz in ISM bands
MHz
bands
3.5
0.01
0.1
1
10
100
12
12
23
𝑑 = [ 3 ] √𝑃
𝑑 = [10]√𝑃
𝑑 = [10]√𝑃
𝑑 = [10]√𝑃
.12
.37
1.2
3.7
12
.12
.38
1.2
3.8
12
.12
.38
1.2
3.8
12
.23
.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the
equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz 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 40.70 MHz.
NOTE 3 An additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150 kHz 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into patient areas.
NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects
and people.