MDMS NIPE Monitor V1 User manual

Continuous monitoring system of comfort/discomfort for newborn infants
MD/PRD/IN16.NIPEV1 V.10 - 12 MAR 2020
User Manual
NIPE Monitor V1
Software version: V2.4.0.0
(CE mark first approved: May 2014)
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C Epi de Soil
270 rue Salvador Allende
59120 LOOS (France)
Tel: [phone] - Fax: [phone]
www.mdoloris.com

Continuous monitoring system of comfort/discomfort for newborn infants
MD/PRD/IN16.NIPEV1 V.10 - 12 MAR 2020
©.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./.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./.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.

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Table of contents
1 Safety precautions ........................................................................................................1
1.1 Warnings ..................................................................................................................1
1.2 Caution.....................................................................................................................5
1.3 Notes ........................................................................................................................7
1.4 Key to symbols.........................................................................................................7
2Presentation of the NIPE Monitor V1 ..........................................................................8
3Physiological principle of the NIPE measurement.......................................................9
4Installation of the NIPE Monitor V1 ..........................................................................10
4.1 Clamping support....................................................................................................10
4.2 ECG monitor connexion .........................................................................................10
4.3 Power connector .....................................................................................................11
5. Start the NIPE Monitoring .........................................................................................12
5.1 Set up language.......................................................................................................13
5.2 Demo mode ............................................................................................................13
5.3 Start a new recording ..............................................................................................13
5.4 Resume the previous recording ...............................................................................14
6NIPE display................................................................................................................15
6.1 ECG capture ...........................................................................................................15
6.2 NIPE index.............................................................................................................16
6.3 Display option of the instantaneous NIPE ...............................................................17
6.4 NIPE browsing .......................................................................................................18
6.5 Day / Night Mode...................................................................................................18
6.6 Standby screen........................................................................................................19
7NIPE Monitor V1 settings..........................................................................................20
7.1 Threshold setting ....................................................................................................20
7.2 Insertion and deletion of events...............................................................................21
7.3 Screenshot ..............................................................................................................22
8End of the NIPE Monitoring.......................................................................................23
8.1 Quit the current recording.......................................................................................23
8.2 Maintenance ...........................................................................................................23
8.3 Records management..............................................................................................23
8.3.1 Export data recordings............................................................................................23
8.3.2 Deletion of data recorded........................................................................................25
8.3.3 Setting of data-rates recorded..................................................................................25
8.4 Events update..........................................................................................................26

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8.5 Date and time settings.............................................................................................27
8.6 Update the monitor .................................................................................................27
8.7 Shut down...............................................................................................................28
9Troubleshooting...........................................................................................................29
10 Monitor disposal..........................................................................................................30
11 Environnement............................................................................................................30
11.1 Shipping and Storage Environnement .....................................................................30
11.2 Operating Environnement.......................................................................................31
11.3 Power Requirements and System Grounding...........................................................31
12 Cleaning and disinfection............................................................................................32
12.1 Cleaning .................................................................................................................32
12.2 Leakage Current......................................................................................................33
13 Specifications, warranty and software license agreement..........................................33
13.1 Specifications .........................................................................................................33
13.2 Warranty.................................................................................................................35
13.3 Software Licence Agreement..................................................................................37

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1 Safety precautions
INTRODUCTION
Caution: carefully read this entire manual before using the monitor in a clinical setting.
WARNING
A warning of this level of danger advises against potentially dangerous situation that could
results in physical injury or death. Accidents may be caused by the inability to avoid
dangerous situation. That is why it is important to follow guidelines in this warning, to avoid
physical injuries.
, CAUTION
A caution of this level of danger advises actions or situations that could damage equipment,
produce inaccurate data, or invalidate a procedure, although personal injury is unlikely.
NOTE
A note provides useful information regarding a function or procedure.
DEFINITION OF SYMBOLS
Symbols used with the NIPE Monitor V1 are explained at the end of this section.
1.1 Warnings
LEAKAGE CURRENT MUST BE CHECKED BY A TECHNICIAN QUALIFIED IN
BIOMEDICAL ENGINEERING WHENEVER INSTRUMENT CASE IS OPENED.
EXPLOSION HAZARD: DO NOT USE THE NIPE MONITOR V1 IN A
FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF
FLAMMABLE ANESTHETICS MAY OCCUR.
THIS MONITOR IS NOT DESIGNED FOR USE IN THE MRI ENVIRONMENT.

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THIS MONITOR COULD NOT BE IN ANY CASE CONSIDERED AS AN ECG
MONITORING SYSTEM.
CONSIDERATIONS WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT)
EQUIPMENT DURING THE NIPE MONITORING: place ECT electrodes as far away
as possible from the sensors to minimize the effect of interference. Some ECT equipment
may interfere with the proper functioning of the NIPE Monitor V1. Check for
compatibility of equipment during patient setup.
ONLY USE THE POWER CORD SUPPLIED BY THE MANUFACTURER. NEVER
ADAPT THE PLUG FROM THE MONITOR TO FIT A NON-STANDARD OUTLET.
NE
IF THE INTEGRITY OF THE EXTERNAL PROTECTIVE EARTH GROUND IS IN
DOUBT, THE NIPE MONITOR V1 SHOULD NOT BE USED.
BE SURE THE MONITOR IS INSTALLED SECURELY TO AVOID ANY INJURY
FOR THE STAFF OR FOR THE PATIENT.
WHEN EXTERNAL EQUIPMENT IS CONNECTED (e.g., DATA CAPTURE
COMPUTER), THE LEAKAGE SYSTEM CURRENT MUST BE CHECKED AND
MUST BE LESS THAN THE IEC 60601-1-1 LIMIT.
USING ACCESSORIES AND CABLES OTHER THAN SPECIFIED OR PROVIDED
BY THE MANUFACTURER OF THE NIPE Monitor V1 (MDOLORIS MEDICAL
SYSTEMS) MAY RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS OR

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DECREASED ELECTROMAGNETIC IMMUNITY OF THE NIPE Monitor V1 AND
MAY RESULT IN AN INAPPROPRIATE OPERATION.
CONSIDERATION RELATING TO THE CHOICE OF EQUIPMENT SHALL
INCLUDE:
- EVIDENCE THAT USING THE ACCESSORY IN THE PATIENT VICINITY AND
OR SURGERY VICINITY IS COMPLIANT
- EVIDENCE THAT THE ACCESSORY'S "CE" SAFETY CERTIFICATION
COMPLIES WITH STANDARD (IEC 60601-1) AND THAT THE ACCESSORY IS
COMPATIBLE WITH THE NIPE Monitor V1
THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS
SHOULD NOT CONTACT OTHER CONDUCTIVE PARTS, INCLUDING GROUND
LOOP.
TO MINIMIZE THE RISK OF STRANGULATION OF THE PATIENT, THE CABLE
OF THE PATIENT INTERFACE MUST BE CAREFULLY PLACED AND
SECURED.
ON ELECTRICAL SHOCK HAZARD :
-DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET
HANDS.
-DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE
POWER IS CONNECTED TO MONITOR.
-THE MANUFACTURER OF THIS DEVICE HAS VERIFIED THAT THE
GROUND LEAKAGE CURRENT AND THE PATIENT SAFETY CURRENT
WERE LESS THAN THE SPECIFIED LIMITS ESTABLISHED BY THE
APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE,
THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO VERIFY THESE
CURRENTS ESPECIALLY WHEN A QUALIFIED BIOMEDICAL

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ENGINEERING TECHNICIAN PERIODICALLY OPENS THE
INSTRUMENT CASE.
-WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS
OCCURS, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER
USE.
IN CASE OF EMERGENCY FOR INTERRUPTING THE ELECTRICAL POWER, IT
IS NECESSARY TO USE THE MALE END OF THE POWER CORD OR THE WALL
SOCKET. THE ACCESS OF THE POWER PLUG AND THE WALL SOCKET HAVE
TO STAY REACHABLE DURING THE NORMAL USE.
CURRENT PRECAUTIONS SHALL BE OBSERVED TO PREVENT ANY
CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS
MATERIALS. CONTAMINATED MATERIALS MUST BE DEALT IN
ACCORDANCE WITH ALL APPLICABLE HYGIENE STANDARDS AND
REGULATIONS.
DO NOT MIX DISINFECTING SOLUTIONS (e.g., BLEACH AND AMMONIA).
HAZARDOUS GASES MAY RESULT.
THE NIPE MONITOR V1 COMPLIES WITH ELECTROMAGNETIC
COMPATIBILITY REQUIREMENTS OF EN 60601-1-2. THE OPERATION OF THIS
DEVICE MAY AFFECT OR BE AFFECTED BY OTHER EQUIPMENTS IN THE
VICINITY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). IF THIS
OCCURS:
- INCREASE THE SEPARATION BETWEEN DEVICES
- CHANGE THE ORIENTATION OF DEVICE CABLING
- PLUG DEVICES INTO SEPARATE CIRCUIT OUTLET

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- PLEASE CONTACT YOUR MDOLORIS MEDICAL SYSTEMS
REPRESENTATIVE.
BE SURE THAT THE MONITOR IS PLACED OUT OF AN AREA PRESENTING A
RISK OF PROJECTION OF LIQUID (E.G.: UNDER AN I.V. BAG).
ANY MODIFICATION IN THE MONITOR IS STRICTLY FORBIDDEN.
USE OF NIPE Monitor V1 ADJACENT TO OR STACKED WITH OTHER
EQUIPMENT SHOULD BE AVOIDED BECAUSE IT COULD RESULT IN
IMPROPER OPERATION. IF SUCH USE IS NECESSARY, THIS EQUIPMENT AND
THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY THAT THEY
ARE OPERATING NORMALLY.
PORTABLE RF COMMUNICATIONS EQUIPMENT (INCLUDING PERIPHERALS
SUCH AS ANTENNA CABLES AND EXTERNAL ANTENNAS) SHOULD BE USED
NO CLOSER THAN 30 CM (12 INCHES) TO ANY PART OF THE NIPE Monitor V1,
INCLUDING CABLES SPECIFIED BY THE MANUFACTURER. OTHERWISE,
DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD
RESULT.
1.2 Caution
Read this entire manual carefully before using the monitor in a clinical setting.
Before you boot the monitor, please ensure there is no USB peripheral connected to the
monitor (USB stick for example).
The equipment should not be reachable by the patient, directly or indirectly, like placed on a
metallic material reachable by the patient.

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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 ;
-The power cord ;
-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.

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1.3 Notes
The “NOTES”can be found at the end of each related chapter.
1.4 Key to symbols
Symbol
Description
Symbol
Description
Operator's manual;
operating instructions
Serial number
Keep dry
European compliance Mark of
compliance with the European
Medical Device Directive
Do not expose to sunlight
General safety sign
Check the packaging
quality upon delivery
Needs special waste disposal
Manufacturer +
Manufacturing Date
Direct current, DC
Upper and lower
temperature limits
(Shipping and Storage
Environment)
“ON” / “OFF”

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Fragile; handle with care
Caution: Federal law restricts
this device to sale by or on the
order of a (licensed healthcare
practitioner)
This way up
2 Presentation of the NIPE Monitor V1
NIPE (Newborn Infant Parasympathetic Evaluation) is a normalized and continuous measure
of the parasympathetic tone (p) which is a part of the autonomous system (ANS). It uses the
punctual and quick increase of pƩ tone induced by each respiratory cycle (spontaneous or
artificial) to measure the “relative quantity” of pƩ tone.
These rapid changes in pƩ tone express in the sinus node of the heart by changes in the time
intervals between two R waves of the electrocardiogram. The pƩ component is evaluated after
filtering, normalization and resampling of the RR series by measuring the area generated by
the respiratory patterns. More important is the pƩ tone, bigger is the measured area.
Rapid ptone variations express themselves directly on the sinus node by variations of time
interval separating two R waves on the electrocardiogram. The normal next RR series
(stemming from a cardiac cycle and not from an extrasystole) establish the RR series. After
filtering, normalization and resampling, the pƩcompound of the RR series is obtained by
measuring the generated surface by the respiratory cycles.
NIPE measurement cannot be interpreted in the following situations:
•Non-sinus cardiac rhythm;
•cardiac graft;
•drugs affecting the sinus node (Atropine…);
•post-conceptional age lower than 26 weeks.
The NIPE index is expressed on a scale between 0 and 100. It reflects the activity of the
parasympathetic nervous system. It gives a reading of the proportion of pƩ tone compared to
the Ʃ tonus in the autonomous nervous system. The NIPE displayed represents the

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successions of computed measures: each elementary measure is carried out on 64 seconds,
with a 1 second moving window.
The NIPE Monitor V1 is intended to be used by pediatricians and pediatric nurses. For a
safety use of the NIPE Monitor V1, the user must know factors that could disturb/skew the
NIPE index calculation related to the autonomous nervous system. The NIPE is a decision
support tool; the user must take account of the other current clinical parameters before taking
a decision or performing a diagnosis.
The diagnostic established with respect to the NIPE index value displayed on the monitor, is
the doctor’s responsibility.
3 Physiological principle of the NIPE measurement
Analysis of Heart Rate Variability (HRV) enables to evaluate the autonomous nervous
system’s variations, whose parasympathetic and sympathetic components control the cardiac
rhythm and its short-term variations. HRV measurement methods are various and validated
for many years: the normal or pathologic functioning of the ANS can be appreciated by these
methods. Some studies showed that the cardiovascular system’s regulatory processes are
closely linked to the perception of pain [1, 2]. Analysis of the heart rate variability (HRV) is a
well-known and non-invasive method for the measure of the cardiovascular system’s
regulation by the autonomous nervous system (ANS) [1, 3]. This analysis is based on the
principle that the fluctuations of the cardiac rhythm are the reflect of the parasympathetic and
sympathetic systems, main components of the ANS. Studies showed that fluctuations of the
heart rate over 0.15 Hz are due to parasympathetic system’s influence [4, 5]. Phenomena of
pain, fear and anxiety, in adults, are accompanied by a decrease of the HRV in high
frequencies (>0.15 Hz) that indicates a decrease of the parasympathetic tone during
nociceptive stimuli and unpleasant emotions [6, 7, 8]. During a surgical operation, analysis of
the HRV is correlated to the balance between nociception and analgesia rate [9]. A significant
decrease of the spectral power in high frequencies, in children, has been observed during
painful surgical acts. This suggests a decrease of the parasympathetic influence during the
nociceptive stimulus [1, 10].
1. Oberlander TF, Grunau RE, Pitfield S, et al. The developmental character of cardiac autonomic
responses to an acute noxious event in 4- and 8-month-old healthy infants. Pediatr Res 1999;
45: 519-25.

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2. Benarroch EE. Pain-autonomic interactions. Neurol Sci 2006; 27 (Suppl 2): S130-3.
3. Schäffer L, Burkhardt T, Müller-Vizentini D, et al. Cardiac autonomic balance in small-for-
gestational-age neonates. Am J Physiol Heart Circ Physiol 2008; 294: H884-90.
4. Saul JP, Berger RD, Albrecht P, et al. Transfer function analysis of the circulation: unique
insights into cardiovascular regulation. Am J Physiol 1991; 261: H1231-45.
5. Parati G, Mancia G, Di Rienzo M, et al. Point: cardiovascular variability is/is not an index of
autonomic control of circulation. J Appl Physiol 2006; 101: 676-8; discussion 681-2.
6. Miu AC, Heilman RM, Miclea M. Reduced heart rate variability and vagal tone in anxiety:
trait versus state, and the effects of autogenic training. Auton Neurosci 2009 28; 145: 99-103.
7. Demaree HA, Robinson JL, Everhart DE, et al. Resting RSA is associated with natural and self-regulated
responses to negative emotional stimuli. Brain Cogn 2004; 56: 14-23.
8. Appelhans BM, Luecken LJ. Heart rate variability and pain: associations of two interrelated homeostatic
processes. Psychol. 2008; 77: 174-82.
9. Jeanne M, Logier R, De Jonckheere J, et al. Heart rate variability during total intravenous anaesthesia:
effects of nociception and analgesia. Auton Neurosci 2009; 147: 91-6.
10. Oberlander TF, Grunau RE, Whitfield MF, et al. Biobehavioral pain responses in former
extremely low birth weight infants at four months' corrected age. Pediatrics. 2000; 105: e6.
4Installation of the NIPE Monitor V1
4.1 Clamping support
Position the monitor in order to handle easily the power plug. The monitor could be installed
on an intravenous stand with the collet fixture. The clamping system can be used on poles
with diameter from 0.75 to 1.49 inches. Please ensure that the pole is compatible.
4.2 ECG monitor connexion
Connect the « Monitor Link » to the analogic port of the ECG monitor, then connect the other
end of the “Monitor Link” cable to the NIPE Monitor V1 (see figure 1).
To identify the analogic ECG output on your multi-parameter monitor, please consult the
operating manual of this multi-parameter monitor.

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Figure 1: connexion cable
Figure 2: Example with the Philips MP50 monitor
Ask for Mdoloris Medical Systems representative if there is any problem.
4.3 Power connector
MONITOR SIDE END
MULTIPARAMETERS MONITOR SIDE END

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The power connector is classically plugged into the base. To prevent any accidental
disconnection, you can lock the coupling screwing the nut on the base (from left to right, see
picture above).
5. Start the NIPE Monitoring
Once the monitor is plugged and connected to the multi-parameter monitor, power up the
monitor with the switch located on the left side of the NIPE Monitor V1 (figure 3).
The green light situated above the screen indicates that the monitor is starting up.
Figure 3
The monitor will start by showing successively Mdoloris Medical Systems’ animations during
the start-up phase. Then, the main menu screen will be displayed (figure 4).

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Figure 4
From the main menu, you can have access to the following functions:
5.1 Set up language
The user can change the language. Select the button [Taal] situated on the top right hand
corner of the main menu (figure 4). The different languages are displayed in a drop down list
(figure 5). Choose the language wanted and press [X] to quit and set up the new language.
Figure 5
5.2 Demo mode
The selection of [Demo] on the top left hand corner of the main menu shows you a video of
the NIPE functioning.
5.3 Start a new recording
The selection of [Start een nieuwe opname] launches a new recording. Then the monitor
displays the monitoring starting by an initialization step (figure 6). This initialization step
takes a minimum of 80 seconds. No data can be interpreted before this initialization time.

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Figure 6
When the initialization is done, the calculation of the index starts automatically and the
monitoring display appears (figure 7).
Figure 7
5.4 Resume the previous recording
The selection of [Herneem de vorige opname] enables to resume the former recording.

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The other functions available from the main menu (figure 4) are presented in the following
chapters:
-Maintenance : cf. Chapter 8.2
-Records management : cf. Chapter 8.3
-Events update : cf. Chapter 8.4
-Date and Time settings : cf. Chapter 8.5
-Update monitor : cf. Chapter 8.6
-Shutting down : cf. Chapter 8.7
To note: The NIPE Monitoring can be used with a conscious patient as well as with an
unconscious one, whenever the clinician needs it.
6NIPE display
6.1 ECG capture
The lower sub-window displays the ECG acquired by the monitor (figure 8).This ECG is
filtered from all environmental artefacts.
Figure 8 - ECG
WARNING:
On the main screen, always check the good quality of the ECG signal:
-At the same time with the signal morphology and the scrolling in the ECG scope.
-In the bottom right hand corner of the screen :
-Good quality signal
-Medium quality signal
-Poor quality signal
Case n°1: No signal is displayed:

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-Check the connection of the cable between the monitor and the multi-parameter
monitor.
-Try at least one time to disconnect and plug again the connection between both
monitors to get back a correct ECG signal.
Case n°2 –Medium quality signal:
When the quality signal is medium, it is to warn the user that the signal quality may become
bad soon.
Case n°3 –Poor signal quality: The indications provided by the monitor can’t be taken in
account if the signal quality reported by the monitor is bad (red colored indicator).
In that case, the NIPE index is not displayed anymore, the curve is not dawned anymore and a
message “poor signal quality” appears in the middle of the screen to warn the user.
-Select the button “Auto Gain”in the bottom right hand corner of the screen to
recalibrate automatically the acquisition of the ECG signal.
-If the signal quality is still medium or poor, choose another ECG lead (on the multi
parameters monitor). Finally, check the good position of the electrodes and their
adhesion on the skin. Stick them again or change them if it is necessary.
6.2 NIPE index
A continuous indicator is displayed reflecting the patient parasympathetic tone (each
elementary measure has been realized on 64 seconds with 1 second of sliding window). A
calculation is realized every second then averaged within a “short” period and a “long”
period. The monitor displays in blue the NIPE averaged over 20 minutes (long period) and, in
red, the instantaneous NIPE when it falls suddenly (significant of the answer to a painful or
stressful stimulus). See figure 9.