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.

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 V.10 - 12 MAR 2020
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

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 V.10 - 12 MAR 2020
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

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 1
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.

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 2
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

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 3
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

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 4
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

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 5
- 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.

NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants
MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020 6
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.