Medivance Arctic Sun Stat, Руководство по обслуживанию

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The current Service Manual can be found at www.medivance.com/manuals
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 BD (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.
• NOTE The EMISSIONS characteristics of this equipment make
it suitable for use in industrial areas and hospitals (CISPR 11
class A). If it is used in a residential environment (for which
CISPR 11 class B is normally required) this equipment might not
offer adequate protection to radio-frequency communication
services. The user might need to take mitigation measures, such
as relocating or re-orienting the equipment.
Accessories and cables approved by BD for use with the
Arctic Sun™ Temperature Management System
Part #
Temperature In-Cable - Nellcor 735-02
Temperature In-Cable - Bard 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 - Bard 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
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 Electromagnetic environment -
guidance
RF emissions
CISPR 11
Group 1 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.
RF emissions
CISPR 11
Class A 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.
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 EUT is intended for use in the electromagnetic environment
specified below. The customer or user of the EUT should ensure that it is
used in such an environment.
Immunity Test
IEC 60601 Test
Level
Compliance
Level Electromagnetic
Environment –
Guidance
ESD
IEC 61000-4-2 C air
+/- 2kV, +/- 4kV
+/- 6kV, +/- 8kV
Air only +/-15 kV
C air
+/- 2kV, +/- 4kV
+/- 6kV, +/- 8kV
Air only +/-15 kV
Floors should be
wood, concrete
or ceramic tile.
If floors are
synthetic, the
r/h should be at
least 30%
Electrical Fast
Transient/Burst
IEC 61000-4-4
AC Power:
±2 kV
SIP/SOP: ±1
kV
100 kHz
repetition
frequency
AC Power: ±2 kV
SIP/SOP: ±1 kV
100 kHz
repetition
frequency
Mains power
quality should
be that of a
typical
commercial
or hospital
environment.
Surge
IEC 61000-4-5 ±0.5 kV, ±1 kV
Line-to-line
±0.5 kV, ±1 kV,
± 2 kV Line-to-
ground
±0.5 kV, ±1 kV
Line-to-line
±0.5 kV, ±1 kV, ± 2
kV Line-to-ground
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
0 % UT; 0,5
cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270° and
315°
0 % UT; 1 cycle
70 % UT;
25/30 cycles
Single phase:
at 0°
0 % UT;
250/300 cycle
0 % UT; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT; 1 cycle
70 % UT; 25
cycles
Single phase:
at 0°
0 % UT; 250
cycle
Mains power
quality should
be that of
a typical
commercial
or hospital
environment. If
the user requires
continued
operation during
power mains
interruptions, it
is recommended
that they find
a suitable
uninterruptible
power supply.
Power
frequency
(50/60 Hz)
Magnetic field
IEC 61000-4-8
30A/M
60 Hz 30A/M
60 Hz Power frequency
magnetic fields
should be that
of a typical
commercial
or hospital
environment.