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Appendix C: Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility. Ensure that the Arctic Sun™ Temperature
Management System is installed and used according to the electromagnetic
compatibility information provided. The following are guidance and
manufacturer's declarations regarding electromagnetic compatibility for
the Arctic Sun™ Temperature Management System.
•
The use of accessories or cables other than those specified or sold by
Medivance (shown below) is not recommended. Use of unapproved
accessories or cables may result in increased emissions or in decreased
immunity of the Arctic Sun™ Temperature Management System.
•
If the Arctic Sun™ Temperature Management System is used directly
adjacent to or stacked with other equipment, the user should periodically
observe the Arctic Sun™ Temperature Management System device to verify
it operates normally in that environment.
•
Portable and mobile RF communications equipment can affect Medical
Electrical Equipment.
Accessories and cables approved by Medivance for use with the
Arctic Sun™ Temperature Management System
Temperature In-Cable - Nellcor
Temperature In-Cable - Bard
Temperature In-Cable - Rusch
Temperature In-Cable - GE
Temperature In-Cable - Philips
Temperature Out-Cable - Nellcor
Temperature Out-Cable - Bard
Temperature Out-Cable - Rusch
Temperature Out-Cable - GE
Temperature Out-Cable - Philips
Power Cord, US, Canada, Mexico
Power Cord, Continental Europe
Power Cord, UK, Ireland
Power Cord, Australia, New Zealand
Power Cord, Mainland China
Power Cord, Brazil
Power Cord, Switzerland
Power Cord, South Africa
Transmission Interface Module (TIM) Kit
Transmission Interface Module (TIM)
RS232 Cord
1.1 EN/IEC 60601-1-2 Table 1
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The Arctic Sun™ Temperature Management System is intended for use in the
electromagnetic environment specified below. The customer or the end user of the
Arctic Sun™ Temperature Management System should assure that it is used in such an
environment.
Emissions test
Compliance
RF emissions
Group 1
CISPR 11
Part #
735-02
735-03
735-04
735-05
735-06
735-52
735-53
735-54
735-55
735-56
733-00
733-01
733-02
733-03
733-04
733-05
733-07
733-08
760-00
761-00
762-00
Electromagnetic environment - guidance
The Arctic Sun™ Temperature
Management System 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.
1.1 EN/IEC 60601-1-2 Table 1 (cont.)
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
Compliance
RF emissions
Class A
CISPR 11
Harmonic emissions
Class A
IEC 61000-3-2
Voltage fluctuations/
Complies
Flicker emissions
IEC 61000-3-3
1.2 EN/IEC 60601-1-2 Table 2
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Arctic Sun™ Temperature Management System unit is intended for use in the
electromagnetic environment specified below. The customer or the end user of the
Arctic Sun™ Temperature Management System unit should assure it is used only in such
an environment.
Immunity Test
IEC 60601 test
level
Electromagnetic
±
6kV contact
discharge (ESD)
±
8kV air
IEC 61000-4-2
±
Electrical fast
2kV for power
transient/burst
supply lines
IEC 61000-4-4
±
1kV for input/
output lines
Surge
±
1kV differential
IEC 61000-4-5
mode (line-line)
±
2kV common
mode (line-earth)
Voltage
<5% UT (>95%
dips, short
dip in UT) for
interruptions and
0.5 cycle
voltage variations
on power supply
40% UT (60%
input lines
dip in UT) for
IEC 61000-4-11
5 cycles
70% UT (30%
dip in UT) for
25 cycles
<5% UT (>95%
dip in UT) for
5 seconds
Power frequency
3A/m
(50/60Hz)
magnetic field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
E N G L I S H
Electromagnetic environment guidance
The Arctic Sun™ Temperature
Management System unit is suitable
for use in all establishments other
than domestic, establishments and
those directly connected to the public
low-voltage power supply network
that supplies buildings for domestic
purposes.
Compliance Level
Intended
Electromagnetic
Environment
±
Floors should be wood,
6kV contact
concrete or ceramic tile.
±
8kV air
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%.
±
Mains power quality
2kV for power
should be that of a
supply lines
typical commercial or
±
1kV for input/
hospital environment.
output lines
±
Mains power quality
1kV differential
should be that of a
mode (line-line)
typical commercial or
±
2kV common
hospital environment.
mode (line-earth)
<5% UT (>95%
Mains power quality
dip in UT) for
should be that of a
0.5 cycle
typical commercial or
hospital environment.
40% UT (60%
If the user of the
dip in UT) for
Arctic Sun™
5 cycles
Temperature
Management System
70% UT (30%
unit requires continued
dip in UT) for
operation during power
25 cycles
mains interruptions, it is
recommended that the
<5% UT (>95%
Arctic Sun™
dip in UT) for
Temperature
5 seconds
Management System
unit be powered from
an uninterruptible
power supply with
sufficient capacity to
run the unit for the
maximum required time
of interruption.
3A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
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