Terumo CDI OneView - Additional Warnings and Precautions

B-14
System Specifications
Additional Warnings and Precautions Additional Warnings and Precautions
Essential performance of the CDI OneView System is primarily to display monitored
parameters within error tolerances and associated visual physiological alarms based
on user-dened limits. Verify the accuracy of displayed values with another source
(such as a laboratory or point-of-care blood gas analyzer) before initiating treatment if
performance is lost or degraded due to EM disturbances.
There are no precautions specic to the CDI OneView System to be taken when a
cardiac debrillator is used on a patient. The typical recovery time from these events
is less than 30 seconds.
There are no precautions specic to the CDI OneView System to be taken when
operating in presence of high-frequency electrosurgical equipment or electrocautery
instrument. The typical recovery time from these events is less than ten seconds.
Warning
 Electromagnetic emission from the CDI OneView System may
interfere with critical devices in its vicinity.
 Following standard practices for electronic devices, monitor this
equipment closely when it is exposed to intense electrical noise
or uctuating line voltage. Strong electromagnetic elds radiated
from equipment elsewhere in the operating room or uctuations
in AC line voltage may compromise performance or damage the
equipment.
 Use of accessories, transducers or cables other than those
specied or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
 It is not recommended to use this system adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary,
observe the system closely to verify normal operation in the
conguration in which it will be used.
 Protection of the device against the effects of a cardiac
debrillator discharge is dependent upon the use of appropriate
cables.
 Portable and mobile radio frequency (RF) communication
equipment can affect this system. RF communications equipment
include, but are not limited to, peripherals such as antenna
cables, external antennas, cell phones, pagers, walkie-talkies
and Bluetooth devices. Portable RF communications equipment
should be used no closer than 30 cm (12 inches) to any part of
the CDI OneView System, including cables specied for use by the
manufacturer. Otherwise degradation of the performance of this
equipment could result.