Appendix C: Electromagnetic Compatibility - Medivance Arctic Sun Simply Advanced 5000 Manuel De L'opérateur

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 Temperature Management System device to
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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 Temperature Management System
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Temperature In-Cable - Nellcor
Temperature In-Cable - B
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Temperature In-Cable - Rusch
Temperature In-Cable - GE
Temperature In-Cable - Philips
Temperature Out-Cable - Nellcor
Temperature Out-Cable - B
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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 A S Temperature Management System is intended for use in the
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electromagnetic environment specified below. The customer or the end user of the
A S Temperature Management System should assure that it is used in such
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an environment.
Emissions test Compliance
RF emissions Group 1
CISPR 11
S Temperature
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Temperature Management System.
Electromagnetic environment - guidance
The A S 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.
1.1 EN/IEC 60601-1-2 Table 1 (cont.)
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
Emissions Test
RF emissions
CISPR 11
Harmonic emissions IEC
61000-3-2
Voltage fluctuations/
Flicker emissions IEC
61000-3-3
1.2 EN/IEC 60601-1-2 Table 2
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The A S
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electromagnetic environment specified below. The customer or the end user of the
A S Temperature Management System unit should assure it is used only in
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such an environment.
Immunity Test
735-02
735-03
735-04 Electromagnetic
discharge (ESD)
735-05
IEC 61000-4-2
735-06
735-52
735-53
Electrical fast
transient/burst
735-54
IEC 61000-4-4
735-55
735-56
Surge
IEC 61000-4-5
733-00
733-01
733-02
Voltage
733-03 dips, short
interruptions and
733-04
voltage variations
on power supply
733-05
input lines
733-07
IEC 61000-4-11
733-08
760-00
761-00
762-00
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
Compliance Electromagnetic environment guidance
Class A The A
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Management System unit is suitable
for use in all establishments other
Class A
than domestic, establishments and
those directly connected to the public
low-voltage power supply network
Complies
that supplies buildings for domestic
purposes.
Temperature Management System unit is intended for use in the
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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 dip in UT) for
0.5 cycle 0.5 cycle
40% UT (60% 40% UT (60%
dip in UT) for dip in UT) for
5 cycles 5 cycles
70% UT (30% 70% UT (30%
dip in UT) for dip in UT) for
25 cycles 25 cycles
<5% UT (>95% <5% UT (>95%
dip in UT) for dip in UT) for
5 seconds 5 seconds
3A/m 3A/m
E N G L I S H
S Temperature
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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
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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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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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