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MDMS NIPE Monitor V1 User Manual

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

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  • Page 1 Continuous monitoring system of comfort/discomfort for newborn infants 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...
  • Page 2 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.

  • Page 3: Table Of Contents

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Table of contents 1 Safety precautions ......................1 Warnings ........................1 Caution ........................5 Notes ........................7 Key to symbols ......................7 Presentation of the NIPE Monitor V1 ................8 Physiological principle of the NIPE measurement ............
  • Page 4 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Date and time settings ..................... 27 Update the monitor ....................27 Shut down ....................... 28 Troubleshooting ......................29 10 Monitor disposal ......................30 11 Environnement ......................30 11.1 Shipping and Storage Environnement ..............30 11.2 Operating Environnement ..................

  • Page 5: Safety Precautions

    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. Warnings LEAKAGE CURRENT MUST BE CHECKED BY A TECHNICIAN QUALIFIED IN BIOMEDICAL ENGINEERING WHENEVER INSTRUMENT CASE IS OPENED.
  • Page 6 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.
  • Page 7 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 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"...
  • Page 8 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants ENGINEERING TECHNICIAN PERIODICALLY OPENS 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.

  • Page 9: Caution

    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.
  • Page 10 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.

  • Page 11: Notes

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Notes The “NOTES” can be found at the end of each related chapter. Key to symbols Symbol Description Symbol Description Operator's manual; Serial number operating instructions European compliance Mark of...

  • Page 12: Presentation Of The Nipe Monitor V1

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Caution: Federal law restricts Fragile; handle with care this device to sale by or on the order of a (licensed healthcare practitioner) This way up 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).

  • Page 13: Physiological Principle Of The Nipe Measurement

    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.

  • Page 14: Installation Of The Nipe Monitor V1

    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.

  • Page 15: Power Connector

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants MONITOR SIDE END MULTIPARAMETERS MONITOR SIDE END 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: 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.

  • Page 17: Set Up Language

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Figure 4 From the main menu, you can have access to the following functions: 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).

  • Page 18: Resume The Previous Recording

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Figure 6 When the initialization is done, the calculation of the index starts automatically and the monitoring display appears (figure 7). Figure 7 Resume the previous recording The selection of [Herneem de vorige opname] enables to resume the former recording.

  • Page 19: Nipe Display

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 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.

  • Page 20: Nipe Index

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 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.

  • Page 21: Display Option Of The Instantaneous Nipe

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Digital value NIPE averaged over 20 minutes Sharp falls of the instantaneous NIPE Figure 9 Display option of the instantaneous NIPE The selection of the button [Instant NIPE] will allow you to follow the instantaneous NIPE on the screen.

  • Page 22: Nipe Browsing

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants NIPE browsing The selection of the button [NIPE Navigatie] during the monitoring will display a navigation window (figure 11) which is used to move forwards and backwards the NIPE curve through time and to view the different events which were possibly inserted.

  • Page 23: Standby Screen

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Figure 12 – Day / Night Mode Standby screen 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.

  • Page 24: Nipe Monitor V1 Settings

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 2) In the bottom right hand corner of the screen : Good quality signal Medium quality signal Poor quality signal 7 NIPE Monitor V1 settings Threshold setting It is possible to add a threshold by pressing the button [Drempel]. A new window will be displayed (figure 14).

  • Page 25: Insertion And Deletion Of Events

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Figure 16 The threshold line will be displayed on the monitoring display like in the figure 17 (see below). Figure 17 Insertion and deletion of events The selection of the button [Gebeurtenissen] on the monitoring display will open a new window (figure 18).

  • Page 26: Screenshot

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants • EDIN > 5 • EDIN < 5 • Slaap • Waak By selecting one of these buttons, the chosen event will be inserted on the NIPE Monitoring display, and also on the NIPE browsing display and on the instantaneous NIPE display.

  • Page 27: End Of The Nipe Monitoring

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants End of the NIPE Monitoring Quit the current recording The selection of the button [Stop monitoring] situated in the bottom right hand corner of the display during the monitoring enables to end the session and to get access to the main menu.
  • Page 28 The NIPE Monitor V1 allows real time transfer data via an RS232 port to an external device. WARNING: Mdoloris recommend the use of an insulation device on the link « RS232 output » between the NIPE Monitor V1 and the device to which it is connected, to respect the electrical insulation and the operator’s protection means.

  • Page 29: Deletion Of Data Recorded

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants The company Demetec GmBH markets a device referenced « Medical RS232 Isolation, type Rsl V1.2 » that meet these standards. 8.3.2 Deletion of data recorded The selection of the button [Verwijder opnames] will lead the deletion of all data previously saved in the memory.

  • Page 30: Events Update

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Figure 25 Events update As explained previously (see chapter 7.2), events corresponding to different clinical moments are predefined in the system. The events inserted during a monitoring can be envisioned on different displays: NIPE Monitoring display (chapter 6.2), instantaneous NIPE display...

  • Page 31: Date And Time Settings

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants Date and time settings To set the clock or the date, you have to select [Stop monitoring] to reach the main menu (figure 27). Then, select [Instellingen datum en tijd].

  • Page 32: Shut Down

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants A message will appear to confirm the success of the updating (figure 30). Press on [Ga terug naar NIPE Monitor V1] to back to the main menu. This step could take few seconds due to the updating process.

  • Page 33: Troubleshooting

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 9 Troubleshooting Problems Perform the following tasks: If failure remains: Contact your No ECG displayed on the Check that the monitor is correctly Mdoloris Medical monitor. connected multi-parameter Systems interlocutor.

  • Page 34: Monitor Disposal

    11 Environnement 11.1 Shipping and Storage Environnement The NIPE Monitor V1 and its accessories can be stored or shipped within the following environmental limits. Note that these limits apply to non-operational storage and shipping situations: Temperature: -20 °C to +60°C...

  • Page 35: Operating Environnement

    11.2 Operating Environnement The NIPE Monitor V1 is not designed for use in areas containing flammable gases or vapors. WARNING: Explosion hazard: do not use the NIPE Monitor V1 in a flammable atmosphere or where concentrations of flammable anesthetics may occur.

  • Page 36: Cleaning And Disinfection

    NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants WITH A THREE-SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE MONITOR. 12 Cleaning and disinfection 12.1 Cleaning WARNING: UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. PUT CONTAMINATED MATERIALS IN REGULATED WASTE CONTAINER.

  • Page 37: Leakage Current

    12.2 Leakage Current The NIPE Monitor V1 is designed so that no periodic maintenance is required. However, leakage current should be systematically checked, after spillage of blood or solutions, or after a major surge in the house electrical system or at least once a year.
  • Page 38 The NIPE Monitor V1 is comply with standard IEC 60601-1-2: 2014 (Ed.4) The NIPE Monitor V1 is compatible with the use of the HR surgery device. The equipment returns to the previous operating mode within 10 seconds without loss of any stored data.

  • Page 39: Warranty

    - 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.
  • Page 40 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants shipping container or equivalent packaging to protect the Product. If Purchaser ships a Product to Mdoloris Medical Systems in unsuitable packaging, any physical damage present in the Product on receipt by Mdoloris Medical Systems (and not previously reported) will be presumed to have occurred in transit and will be the responsibility of Purchaser.

  • Page 41: Software Licence Agreement

    WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. 13.3 Software Licence Agreement The computer software (“Licensed Software”) loaded on the NIPE Monitor V1 (“System”) is licensed, not sold, to you for use only under the terms of this license. Mdoloris Medical Systems reserves any rights not explicitly granted.
  • Page 42 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants YOUR REQUIREMENTS OR THAT THE OPERATION OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT SUCH ERRORS IN THE LICENSED SOFTWARE WILL BE CORRECTED. 5. LIMITATION OF REMEDIES AND DAMAGES: MDOLORIS MEDICAL...
  • Page 43 NIPE Monitor V1 - Continuous monitoring system of comfort./.discomfort for newborn infants 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: please contact your Mdoloris Medical Systems representative or contact@mdoloris.com...

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