Medivance BD Arctic Sun 6000, Руководство оператора

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The current Operator’s Manual can be found at www.medivance.com/manuals
English
39
APPENDIX A: 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 ±8kV
Contact
± 2 kV, ± 4
kV, ± 8 kV,
± 15 kV air ±8kV Contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air 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; 25/30 cycles
Single phase: at 0°
0 % UT; 250/300 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
50/60 Hz 30A/M
50/60 Hz Power frequency
magnetic fields
should be that of a
typical commercial
or hospital
environment.
1.3 EN/IEC 60601-1-2: Table 3:
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity