Appendix C: Electromagnetic Compatibility - Medivance Simply Advanced Arctic Sun 5000 Manual De Instrucciones

Appendix C: Electromagnetic Compatibility

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