Continuous monitoring system of comfort/discomfort for newborn infants
MD/PRD/IN16.NIPEV1 V.10 - 12 MAR 2020
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Mdoloris Medical Systems. All rights reserved. Copying or other
reproduction of this document is prohibited without prior written
consent of Mdoloris Medical Systems.
Mdoloris Medical Systems is a commercial registered trademark.
Important information about using continuous monitoring system
of comfort / discomfort for newborn infants:
The Mdoloris Medical Systems’ continuous comfort
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/
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discomfort of
newborn infants monitoring system is intended for use in a medical
environment and under the direct supervision of a licensed
healthcare practitioner or by personnel specifically trained for its
use. The continuous monitoring system of comfort/ discomfort for
newborn infants is intended for using on patients younger than two
years old in a hospital or in a health care facility in order to monitor
the parasympathetic tone activity.
The continuous monitoring system of comfort
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/
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discomfort for
newborn infants can be used to monitor the effects of certain
analgesic agents which will improve the comfort.
NIPE is a complex monitoring technology intended to be used as an
adjunct to clinical judgment and to clinical experience. The
interpretation of the NIPE value must always be submitted to the
clinical judgment and with other available clinical signs observed. It
is advisable to not rely only on the NIPE index for monitoring the
patient comfort. As with all monitored parameters, artifacts and
poor signal quality may lead to inappropriate NIPE values. Potential
artifacts may be caused by muscle activity or rigidity, patient
motion, improper sensor placement or electrical interference.
The NIPE Monitor V1 allows real time transfer data via an RS232
port to an external device. In no case shall transferred data be used
for diagnostic purposes. Only the values displayed on the NIPE
software interface can lead to a medical interpretation.
The NIPE Monitor V1 needs special precautions regarding
environments. The NIPE Monitor V1 has to be installed and put into
service in hospitals and away from the RF source magnetic
resonance imaging.
NIPE is a protected trademark.
