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NIPE Monitor V1 - Continuous monitoring system of comfort

discomfort for newborn infants

MD/PRD/IN16.NIPEV1 v.10 - 12 MAR 2020

In attendance of electromagnetic disturbances the performances listed below can be lost or

degraded:

•

ECG signal can be noisy

This does not affect patient or equipment safety.

Classification:

- CISPR 11: Class B

- IIa Electro-Medical Equipment

13.2

Warranty

Mdoloris Medical Systems warrants to the initial Purchaser that the NIPE Monitor V1

(“Warranted Product”) will be free from defects in workmanship or materials, when given

normal, proper, and intended usage for a period of one year (“Warranty Period”) from the date

of its initial shipment to Purchaser. Excluded from this warranty are items such as cables and

accessories. Mdoloris Medical Systems’ obligations under this warranty are to repair or

replace any Warranted Product (or part thereof) that Mdoloris Medical Systems reasonably

determines to be covered by this warranty and to be defective in workmanship or materials

provided that the Purchaser has given notice of such warranty claim 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 request repair or replacement under this warranty, Purchaser should contact Mdoloris

Medical Systems directly. Mdoloris Medical Systems will authorize Purchaser to return the

Warranted Product (or part thereof) to Mdoloris Medical Systems. Mdoloris Medical Systems

shall determine whether to repair or replace Products and parts covered by this warranty and

all Products or parts replaced shall become Mdoloris Medical Systems’ property. In the

course of warranty service, Mdoloris Medical Systems may but shall not be required to make

engineering improvements to the Warranted Product or part thereof. If Mdoloris Medical

Systems reasonably determines that a repair or replacement is covered by the warranty,

Mdoloris Medical Systems shall bear the costs of shipping the repaired or replacement

Product to Purchaser. All other shipping costs shall be paid by Purchaser. Risk of loss or

damage during shipments under this warranty shall be borne by the party shipping the

Product. Products shipped by Purchaser under this warranty shall be packaged in the original

Содержание NIPE Monitor V1

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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