Users Manual Part 1

76
Nerve Integrity Monitor
Legal information
Contact information
For further information regarding the use of this product or to report any problems, please contact Medtronic customer service at 1
800 874 5797; or refer to the last page of this manual for address information.
Open source software disclosure
The following open source software disclosure information applies to the NIM Vital system:
• This document identies the Open Source Software that may be separately called, executed, linked, aliated, or otherwise
utilized by this product.
• Such Open Source Software is licensed to users subject to the terms and conditions of the separate software license agreement
for such Open Source Software.
• Use of the Open Source Software by you shall be governed entirely by the terms and conditions of such license.
• The source/object code and applicable license for any Open Source Software can be obtained at the following site(s): Ubuntu –
https://www.ubuntu.com/
Guidance and manufacturer’s declaration – electromagnetic emission and immunity
Environment of intended use: professional healthcare facility environment
Guidance and manfacturer’s declaration - electromagnetic emissions
The NIM Vital is intended for use in the electromagnetic environment specied below. The customer or the user of the NIM Vital should assure that it is used in such
an environment.
Emissions test Compliance Electromagnetic environment – guidance
RF emission
CISPR 11
Group 1 The NIM Vital 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 emission
CISPR 11
Class A The NIM Vital is suitable for use in all establishments other than domestic establishment
and those directly connected to the public low-voltage power supply network that supplies
buildings for domestic purpose.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage uctuations/
icker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity – Part I
The NIM Vital is intended for use in the electromagnetic environment specied below. The customer or the user of the NIM Vital should assure that it is used in such
an environment.
Immunity test IEC/EN60601-1-2 test level Compliance level Electromagnetic environment - guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
The relative humidity should be at least 5%.
Electrical fast transient/burst
IEC 61000-4-4
±2kV for power supply lines
±1kV for input/output lines
±2kV for power supply lines
±1kV for input/output lines
Mains power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±1kV line to line
±2 kV line to earth
±1kV line to line
±2kV line to 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
0 % U
T
(100 % dip in U
T
) for 0.5
cycle at 0°, 45°, 90°, 135°, 180°,
225°, 270°, and 315°
0 % U
T
(100 % dip in U
T
) for 0.5
cycle at 0°, 45°, 90°, 135°, 180°,
225°, 270°, and 315°
Mains power quality should be that of a typical commercial
or hospital environment. If the user of the NIM Vital requires
continuous operation during power mains interruptions,
it is recommended that the NIM Vital be powered from an
uninterruptible power supply or a battery.
0 % U
T
(100 % dip in U
T
) for 1
cycle at 0°
0 % U
T
(100 % dip in U
T
) for 1
cycle at 0°
40 % UT (60 % dip in UT) for 5
cycles
40 % UT (60 % dip in UT) for 5
cycles
70 %UT (30 % dip in UT) for 0.5
sec
70 % UT (30 % dip in UT) for 0.5
sec
0 % UT (100 % dip in UT) for 5 sec 0 % UT (100 % dip in UT) for 5 sec
Power frequency (50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic elds 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.
FCC use only, not for Medical use