natus UltraPro S100, User Manual, Page: 84 / 88

UltraPro S100
6-10 September 13, 2018
General essential performance criteria
The UltraPro S100 shall not become dangerous or unsafe as a result of
application of tests.
In normal operation mode, essential performance is defined as follows:
The displayed waveform may contain electrical artifacts presented during the
susceptibility testing, but should continue to update display while operating
expect while in “fail safe “mode.
Communication in between the base unit, amplifier and host PC may be lost
during immunity testing as long as user can recover by re-powering the system
and/or re start the application software.
These deviations of operation are considered acceptable as this has been
determined to not pose an unacceptable risk to patients.
Compliance for the
Electrical, VEP, and
AEP stimulator
The Electrical stimulation is monitored by measuring during all tests while
operating In CC mode, during immunity test Stimulation is actively stimulating
or switches to safe mode = 0mA and stop pulsing. Before and after immunity test
pulse max deviation remains within 10%.
Visual Stimulation mode will be active and LED goggles will be active and
visually monitored.
Auditory Stimulation will be active and the headphone will be monitored to
ensure consistent functionality. Stimulation will continue to function throughout
the immunity testing, except when fail safe condition occurs and the stimulation
is stopped.
Compliance for the
amplifier
The amplifier curves can be disturbed during testing, but must return to baseline
after test completion. During Fast Transients and ESD, much higher disturbances
are allowed and immunity level shall not be noted. Before and after immunity
test Amplifier curves disturbance should be, max 5µVpp.
Compliance for
intended operation
Ultrapro S100 shall remain safe and be restorable in case of cessation or
interruption of any intended operation during immunity tests. Disturbance of
display, re-connection of PC USB keyboard and USB mouse or loss of USB
connection to Main Unit does not constitute noncompliance
Compliance to no
damage allowed
Ultrapro S100 Start-up test performs without unexpected errors.