A S 5 0 0 0 S E R V I C E M A N U A L
42
Appendix C: Electromagnetic Compatibility
Medical electrical equipment needs special precautions regarding
electromagnetic compatibility. Ensure that the
A
rctic
S
un
®
5000 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
A
rctic
S
un
®
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
A
rctic
S
un
®
5000 Temperature Management System.
• If the
A
rctic
S
un
®
Temperature Management System is used directly
adjacent to or stacked with other equipment, the user should periodically
observe the
A
rctic
S
un
®
5000 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
A
rctic
S
un
®
5000/5000E Temperature
Management System
Part #
Temperature In-Cable -Nellcor
735-02
Temperature In-Cable -
B
Ard
735-03
Temperature In-Cable -Rusch
735-04
Temperature In-Cable -GE
735-05
Temperature In-Cable -Philips
735-06
Temperature Out-Cable -Nellcor
735-52
Temperature Out-Cable -
B
Ard
735-53
Temperature Out-Cable -Rusch
735-54
Temperature Out-Cable -GE
735-55
Temperature Out-Cable -Philips
735-56
Power Cord, US, Canada, Mexico
733-00
Power Cord, Continental Europe
733-01
Power Cord, UK, Ireland
733-02
Power Cord, Australia, New Zealand
733-03
Power Cord, Mainland China
733-04
Transmission Interface Module (TIM) Kit
760-00
Transmission Interface Module (TIM)
761-00
RS232 Cord
762-00
1.1 EN/IEC 60601-1-2 Table 1
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The
A
rctic
S
un
®
5000 Temperature Management System is intende d for use in the
electromagnetic environment specified below. The customer or the end user of the
A
rctic
S
un
®
5000 Temperature Management System should assure that it is used in
such an environment.
Emissions test
Compliance Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The
A
rctic
S
un
®
5000 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.
RF emissions
CISPR 11
Class A
The
A
rctic
S
un
®
5000 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.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flicker emissions IEC
61000-3-3
Complies
1.2 EN/IEC 60601-1-2 Table 2
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The
A
rctic
S
un
®
5000 Temperature Management System unit is intended for use
in the electromagnetic environment specified below. The customer or the end user
of the
A
rctic
S
un
®
5000 Temperature Management System unit should assure it is
used only in such an environment.
Immunity Test
IEC60601 test
level
Compliance
Level
Intended
Electromagnetic
Environment
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+- 6kV contact
+- 8kV air
+- 6kV contact
+- 8kV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered
with synthetic material,
the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+-2kV for power
supply lines
+-1kV for input/
output lines
+-2kV for power
supply lines
+-1kV for input/
output lines
Mains power quality
should be that of a
typical commercial or
hospital environment.
Surge
IEC 61000-4-5
+-1kV differential
mode (line-line)
+-2kV common
mode (line-earth)
+-1kV differential
mode (line-line)
+-2kV common
mode (line-earth)
Mains power quality
should be that of a
typical commercial or
hospital environment.
Voltage
dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UT (>95%
dip in UT) for 0.5
cycle
40% UT (60%
dip in UT) for 5
cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip in UT) for 5
seconds
<5% UT (>95%
dip in UT) for 0.5
cycle
40% UT (60%
dip in UT) for 5
cycles
70% UT (30%
dip in UT) for 25
cycles
<5% UT (>95%
dip in UT) for 5
seconds
Mains power quality
should be that of a
typical commercial or
hospital environment.
If the user of the
A
rctic
S
un
®
5000
Temperature
Management System
unit requires continued
operation during power
mains interruptions,
it is recommended
that the
A
rctic
S
un
®
5000 Temperature
Management System
unit be powered from
an uninterruptible
power supply with
sufficient capacity to
run the unit for the
maximum required time
of interruption.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3A/m
3 A/m
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial or
hospital environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
