MDMS NIPE Monitor V1 User Manual Download Page 1

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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: 03 62 09 20 80 - Fax: 09 72 38 75 27

www.mdoloris.com

Summary of Contents for NIPE Monitor V1

Page 1: ...16 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 B timent C Epi de Soil 270 rue Salvador...

Page 2: ...mfort 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 cli...

Page 3: ...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 6 NIPE display 15 6 1 ECG capture 15 6 2 NIPE index 16 6 3 Display option...

Page 4: ...9 Troubleshooting 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 a...

Page 5: ...ng 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 in...

Page 6: ...lity 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 PROTE...

Page 7: ...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 I...

Page 8: ...EACHABLE 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...

Page 9: ...E 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 N...

Page 10: ...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 t...

Page 11: ...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 sunlig...

Page 12: ...ormalization and resampling of the RR series by measuring the area generated by the respiratory patterns More important is the p tone bigger is the measured area Rapid p tone variations express themse...

Page 13: ...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 in...

Page 14: ...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...

Page 15: ...newborn infants MD PRD IN16 NIPEV1 v 10 12 MAR 2020 11 Figure 1 connexion cable Figure 2 Example with the Philips MP50 monitor Ask for Mdoloris Medical Systems representative if there is any problem...

Page 16: ...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 t...

Page 17: ...t 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 corn...

Page 18: ...D IN16 NIPEV1 v 10 12 MAR 2020 14 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 previou...

Page 19: ...ter 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 6 NIPE display 6 1 ECG capture The lower sub window displays...

Page 20: ...age 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 t...

Page 21: ...to follow the instantaneous NIPE on the screen A window will open itself to display the instantaneous NIPE s curve figure 10 Figure 10 By selecting the button X in the bottom left hand corner of the...

Page 22: ...ackwards the NIPE curve through time and to view the different events which were possibly inserted Figure 11 By selecting the button X the window of the NIPE browsing will close itself The signal acqu...

Page 23: ...een From 10 minutes of inactivity the screen automatically switches to a standby screen figure 13 except if one of these windows is opened instantaneous NIPE NIPE Navigation Threshold Events To go bac...

Page 24: ...eshold setting It is possible to add a threshold by pressing the button Drempel A new window will be displayed figure 14 Touch the small square next Activeer drempel in order to put a check mark in it...

Page 25: ...1 Figure 16 The threshold line will be displayed on the monitoring display like in the figure 17 see below Figure 17 7 2 Insertion and deletion of events The selection of the button Gebeurtenissen on...

Page 26: ...ick on the button X to get back to the monitoring display 7 3 Screenshot When the user selects the button Screen shot all the information displayed is saved in the monitor s memory as picture format E...

Page 27: ...coming back to the current patient will be possible If you choose Ja the main menu will be displayed figure 4 page 16 8 2 Maintenance The selection of the button Onderhoud in the main menu will open...

Page 28: ...with Windows Excel for example The files will be exported in a folder created on the USB key like for the screenshots chapter 7 3 The title of each file indicates the date and hour when the monitoring...

Page 29: ...he button Verwijder opnames will lead the deletion of all data previously saved in the memory A request for confirmation is proposed figure 23 When all data are deleted another window will appear to c...

Page 30: ...nts list select Update gebeurtenissen The events update menu will appear figure 26 Figure 26 To add new event in the list you have to use the virtual keyboard on the touch screen and then click on Val...

Page 31: ...Then select Instellingen datum en tijd The following window will appear Use the arrows next each number to choose the modifications that you want To validate the changes done you have to confirm by se...

Page 32: ...re 31 If the NIPE exe is not present on the USB key a message appears figure 32 Figure 32 8 7 Shut down The selection of the button Afsluiten ends the session and will shut down the monitor NOTE It is...

Page 33: ...iac monitor Contact your Mdoloris Medical Systems interlocutor No one of the connection adaptors provided with the NIPE Monitor V1 matches with the analogic ECG output of the cardiac monitor Contact y...

Page 34: ...n card No metal element is molded in the thickness of the monitor s housing The inner surfaces of the housing are covered with a protection against electromagnetic interference The screen has a touch...

Page 35: ...monitor is designed to operate safely in a temperature from 5 C to 35 C to an altitude of 2000 meters The conditions that exceed these limits may modify its reliability The monitor is designed to ope...

Page 36: ...the connector ends with alcohol and allow it to dry completely Residual moisture inside the connector may affect the monitoring performance Cleaning the screen Clean the monitor display screen with a...

Page 37: ...els system check and leakage courant check according to the 62353 standard for more details refer to the technical manual available from Mdoloris However leakage current must be checked systematically...

Page 38: ...tion only but which includes an additional safety precaution Means are provided for the connection of the equipment to the protective earth conductor in the fixed wiring of the installation in such a...

Page 39: ...laim within the Warranty Period and the Warranted Product is returned to the factory with freight prepaid Repair or replacement of Products under this warranty does not extend the Warranty Period To r...

Page 40: ...edical Systems unless authorized by Mdoloris Medical Systems Mdoloris Medical Systems shall have no obligation to make repairs replacements or corrections which result in whole or in part from normal...

Page 41: ...Software or its related documentation to others You shall not modify or translate the Licensed Software or its related documentation without the prior written consent of Mdoloris Medical Systems The...

Page 42: ...OUT OF THE USE OF OR INABILITY TO USE ANY LICENSED SOFTWARE EVEN IF MDOLORIS MEDICAL SYSTEMS OR ANY AUTHORIZED MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAG...

Page 43: ...nts MD PRD IN16 NIPEV1 v 10 12 MAR 2020 39 For any incident please report to Mdoloris Medical Systems at service qualite mdoloris com and or to the National Competent Authority For any other problem p...

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