NIPE Monitor V1 - Continuous monitoring system of comfort
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discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020
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The patient and the equipment should not be touched simultaneously by the doctor.
Before any use, check for compatible ECG source isolation corresponding to the applicable
standards to increase patient isolation safety.
The signal provided by the ECG source must be a Very Low Security Tension output.
Do not put the monitor in an autoclave. Putting the monitor in an autoclave will seriously
damage the NIPE Monitor V1.
Using accessories other than those specified may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the monitor.
The NIPE Monitor V1 should not be used adjacent or stacked on other equipment.
If adjacent
or stacked use is necessary, check regularly that the functioning is normal in this
configuration.
Only staff of Mdoloris Medical Systems is allowed to perform maintenance operations or
repairs
. Only the following elements can be replaced or substituted by an untrained staff to
the technical maintenance (respecting the manufacturer references):
-
« Monitor Link » cable and its different connectors ;
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The power cord ;
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The power supply box.
The recycling of this medical equipment, its components and packaging must be done in
accordance with the national laws of the country on electronic wastes and environment.
Be sure that the multi-parametric monitor on which the NIPE Monitor V1 is connected
complies with the electromagnetic compatibility requirements of the IIa classification and the
double patient isolation IEC 60601-1.
Ask for the list of multi-parameter monitors which are compatible with the NIPE Monitor V1
from your Mdoloris Medical Systems representative. Each of these monitoring systems needs
a specific connection adaptor. Please ensure you have transmitted these specifications to your
Mdoloris Medical Systems representative.
