Mdoloris ANI Monitor V1 User Manual
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Mdoloris ANI Monitor V1 User Manual

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Continuous analgesia monitoring system
Tel: +33 (0)3 62 09 20 80 - Fax: +33 (0)9 72 38 75 27
MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021
Analgesia Nociception Index
ANI Monitor V1
User manual
Software version 1.1.4.0
(CE mark first approved on April 2012)
MDOLORIS MEDICAL SYSTEMS SAS
Biocentre Fleming
Bâtiment C Epi de Soil
270 rue Salvador Allende
59120 LOOS (France)
www.mdoloris.com

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  • Page 1 Continuous analgesia monitoring system Analgesia Nociception Index ANI Monitor V1 User manual Software version 1.1.4.0 (CE mark first approved on April 2012) MDOLORIS MEDICAL SYSTEMS SAS Biocentre Fleming Bâtiment C Epi de Soil 270 rue Salvador Allende 59120 LOOS (France) Tel: +33 (0)3 62 09 20 80 - Fax: +33 (0)9 72 38 75 27 www.mdoloris.com...
  • Page 2 ANI Monitor V1 is a complex monitoring technology intended for use as an adjunct to clinical judgment. Clinical judgment should always be used when interpreting the ANI index in conjunction with other available clinical signs.

  • Page 3: Table Of Contents

    Export Data ........................ 35 Update of events ......................36 Date and time settings ....................37 7.10 Update monitor ......................38 7.11 Shutting down the ANI Monitor V1 ................41 Troubleshooting ......................41 Monitor disposal ......................42 10 Environnement ........................ 42 10.1 Shipping and Storage Environnement ...............
  • Page 4 ANI Monitor V1 - Continuous analgesia monitoring system 11.2 Maintenance ......................... 45 11.3 Leakage Current ......................45 12 Specifications, warranty and software license agreement ........... 46 12.1 Specifications ....................... 46 12.2 Warranty ........................47 12.3 Software License Agreement ..................49...

  • Page 5: Safety Precautions

    • A NOTE provides useful information regarding a function or procedure. KEY TO SYMBOLS A key to the symbols that may appear on the ANI Monitor V1 appears at the end of this section. Warnings LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
  • Page 6 ANI Monitor V1 - Continuous analgesia monitoring system NEITHER THE MONITOR NOR THE SKIN ELECTRODES ARE DESIGNED FOR USE IN THE MRI ENVIRONMENT. THIS ANI Monitor V1 COULD NOT BE IN ANY CASE CONSIDERED AS AN ECG MONITORING SYSTEM. CONSIDERATIONS WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT) EQUIPMENT DURING THE ANI MONITORING: place ECT electrodes as far away as possible from the sensors to minimize the effect of interference.
  • Page 7 ENSURE PROPER CONTACT OF THE ELECTROSURGERY RETURN ELECTRODE TO AVOID POSSIBLE BURNS ON THE PATIENT VIA ANI ELECTRODES. THE CHARACTERISTICS OF ANI Monitor V1 EMISSIONS ALLOW IT TO BE USED IN INDUSTRIAL AREAS AND HOSPITALS (CISPR 11 CLASS A). WHEN USED IN RESIDENTIAL ENVIRONMENTS (FOR WHICH CISPR 11 CLASS B IS REQUIRED), MD/PRD/IN16.ANIV1 V.10 –...
  • Page 8 THE INTERFACE WIRE HAS TO BE CAREFULLY PLACED AND HELD DOWN TO PREVENT ANY PATIENT STRANGULATION RISK. DO NOT PLACE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADLLE WHEN IT’S USED ON A PATIENT CONNECTED TO THE ANI Monitor V1. USE AGAIN AN ARRAY ALREADY USED ON PREVIOUS PATIENT COULD LEAD RISK OF CROSS-CONTAMINATION.
  • Page 9 ANI Monitor V1 - Continuous analgesia monitoring system THE APPLICABLE SAFETY STANDARDS. AS A MATTER OF SAFE PRACTICE, THE INSTITUTION SHOULD ALSO CONDUCT TESTS TO VERIFY THESE CURRENTS ESPECIALLY WHEN QUALIFIED BIOMEDICAL 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.

  • Page 10: Cautions

    Equipment should not be reachable by the patient. ANI Monitor V1 should not be used adjacent or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it will be used.
  • Page 11 The internal battery is not designed to withstand alone a long time monitoring. The internal battery of the ANI Monitor V1 allows the system to keep calculating the ANI while the patient is moved to another room or in case of temporary interruption of electrical main supply.

  • Page 12: Notes

    ANI Monitor V1 - Continuous analgesia monitoring system Never use the ANI Monitor V1 while a surgery only with the battery power. The monitor must be plugged on electrical main supply, especially while an electrical bistoury is used. The recycling of this medical equipment (including the packaging) must be done in accordance with the national laws of the country on electronic wastes and environment.

  • Page 13: Ani Monitor V1 Presentation

    ANI Monitor V1 - Continuous analgesia monitoring system General safety sign Manufacturer + Manufacturing Date Protective earth; protective ground 2 ANI Monitor V1 presentation ANI (Analgesia Nociception Index) is an online continuous measurement of the parasympathetic tone (p), which is a part of the autonomous system (ANS). Each respiratory cycle induces in the ANS a temporary fall of p...

  • Page 14: Ani Monitor V1 Installation

    ANI Monitor V1 - Continuous analgesia monitoring system • irregular spontaneous ventilation (patient speaking, laughing or coughing) • pace maker (certain types) • cardiac graft • drugs affecting the sinus node (atropine, glycopyrrolate, etc.) The ANI index is expressed on a scale between 0 and 100. It gives a reading of the proportion of p...

  • Page 15: Ani Sensor V1 / Ani Sensor V2 / Ani Sensor V1 Plus

    ANI Sensor V1 / ANI Sensor V2 / ANI Sensor V1 PLUS The ANI calculation is based on the RR intervals variability of ECG. The ANI Monitor V1 being not an ECG monitor, the electrodes have been designed to retrieve information related to QRS complex.
  • Page 16 Never put electrodes on injuries. Figure 4 NOTE: The ANI Monitor V1 has been designed to work with specific disposable electrodes. It is inadvisable using another kind of electrode. The electrode packaging is ten per bag. The purchase of new electrodes is available through a box with ten bags inside thus in total one hundred arrays.

  • Page 17: Ani Monitor V1 Connexion

    ANI Monitor V1 - Continuous analgesia monitoring system The biocompatibility has been made on every Mdoloris Medical Systems’ array. They match with ISO10993-5 and 10993-10. Before connecting, carefully align the notches on the connection support for a perfect match pins (figures 5 and 7). To disconnect the electrodes, grasp the plastic support by pressing on the locking mechanism and pull it normally to disengage it (figure 6).

  • Page 18: Battery

    Battery ANI-SENS-V1PLUS The ANI Monitor V1 contains an internal battery. The internal battery of the ANI Monitor V1 allows the system to keep calculating the ANI while the patient is moved to another room or in case of temporary interruption of electrical main supply. The internal battery is not designed to withstand alone a long time monitoring.

  • Page 19: Beginning The Ani Monitoring

    (see figure 13 below) to power the monitor up again. The power indicator becomes bright. Never use the ANI Monitor V1 while a surgery only with the battery power. The monitor must be plugged on electrical main supply, especially while an electrical bistoury is used.
  • Page 20 As a brutal stop, it could occur serious damages for next ignition and prevent a correct use. The monitor will start by showing Mdoloris Medical Systems logo animations successively. The first measure of the ANI will take at least 80 seconds. No data can be interpreted before this initialization time lapse.
  • Page 21 ANI Monitor V1 - Continuous analgesia monitoring system Figure 15 Ensure the good quality of the ECG signal in the inferior part of the screen. If there is no signal whatsoever, check the USB connection between the monitor and the acquisition device.

  • Page 22: Ani Computing Process

    ANI Monitor V1 - Continuous analgesia monitoring system 5 ANI computing process ECG Capture At the bottom of the screen a sub-window displays the ECG acquired (figure 16). This ECG is filtered from all technical artifacts as well as from physiological ones (e.g. extrasystoles). In addition to this first step, we have developed an innovating algorithm based on the Fast Wavelets Transform, allowing us to precisely identify the R spics from the QRS signal.

  • Page 23: Ani Index

    ANI Monitor V1 - Continuous analgesia monitoring system bigger stripped surface = high p tone Figure 18: R-R normalized series: high sinus respiratory arrhythmia amplitude ANI Index We have developed an innovating algorithm based on the amplitude assessment of respiratory patterns of the RR series.

  • Page 24: Navigation Panel

    ANI Monitor V1 - Continuous analgesia monitoring system Patient tendency (medium trend) Instantaneous ANI Figure 20 So we give in the left window two curves (yellow and orange) that reflect the patient tendencies with time scale (figure 21). Figure 21 If R waves are not correctly detected, or too many ectopic beats are corrected, ANI measurements are suspended until ECG detection is correct or normal sinus rhythm is back.

  • Page 25: Ani Monitor V1 Setup

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 22 Pressing the [X] button will close this window. ECG acquisition and HRV measures are not disturbed, even if not displayed, when the navigation window has been opened. 6 ANI Monitor V1 setup Pressing the button [Parametrii] in the bottom right hand corner of the screen during the monitoring gives the possibility to access to the following settings.
  • Page 26 ANI Monitor V1 - Continuous analgesia monitoring system Figure 23 If you click on the [X] button without capturing the threshold values, a new window will appear (figure 24): click on [OK]. Figure 24 Click on the first input field and capture a first threshold value (figure 25). Click on [Validare] to validate.
  • Page 27 ANI Monitor V1 - Continuous analgesia monitoring system Figure 25 Figure 26: example with the two captured threshold values Figure 26 MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

  • Page 28: Events Insert

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 27: Threshold values Figure 27 Events insert As shown in the screen below (figure 28), here you have the possibility to insert clinic events so that they can be visible into the tendencies curves and also in the exportable data. Pressing anyone of these buttons inserts a mark in the ANI trend panel and in the recorded RR file.

  • Page 29: Expert Mode And Energy Index

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 28 An example of a file’s content is given below: • ok breathing • extubation • cough • trble breathing • no stimulation • re-inject morphinic • induction • surg stimulation •...
  • Page 30 ANI Monitor V1 - Continuous analgesia monitoring system Figure 29 • “Expert” mode which displays respiratory pattern and one more function called “Energy” (figure 30) Figure 30 The Energy index is equivalent to the “total spectral power of the autonomous nervous system”.
  • Page 31 ANI Monitor V1 - Continuous analgesia monitoring system calculated at this specific moment is not significant of the patient’s parasympathetic tone value. If the Energy index is lower than 0.05 or above 2.5, the ANI calculation is interrupted even if the ECG is still acquired. An Energy index lower than 0.05 or above 2.5 is not significant of the patient’s parasympathetic tone.

  • Page 32: Operating The Ani Monitor V1

    ANI Monitor V1 - Continuous analgesia monitoring system 7 Operating the ANI Monitor V1 Quit Patient Pushing the button [ieşire pacient] in the top of the screen will end the monitoring and give access to main menu. A confirmation window will appear before definitively stop the monitoring (figure 32).

  • Page 33: Demo

    Maintenance Selecting [Întreţinere] (figure 33) opens a window with an input field (see figure 34 next page). This access is protected by a code that will be forwarded on request to Mdoloris Medical Systems. Figure 34 Delete patients data Pressing the button [Golire] deletes all data previously computed and saved.

  • Page 34: Screen Shot

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 35 When all data are deleted, another window will appear to confirm that the action is done (figure 36). Press the button [OK] to back to the main menu (figure 33).

  • Page 35: Export Data

    ANI Monitor V1 - Continuous analgesia monitoring system To get these pictures, a USB stick has to be plugged in the USB port called “Data Export”. Then the user selects [ieşire pacient] in the top of the screen. In the new window opened (figure 33), choose [Export].

  • Page 36: Update Of Events

    ANI Monitor V1 - Continuous analgesia monitoring system be created on the USB device. Each file name will follow this rule: Hour – Minute – Month – Day - Year. Example: It is also possible to do a permanent download by connecting a computer on serial port “3”...

  • Page 37: Date And Time Settings

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 40 To add new event in the list, you have to use the virtual keyboard on the touch screen and √ then valid with the button [ Validare]. Word size is limited to 18 characters.

  • Page 38: Update Monitor

    7.10 Update monitor In the main menu, select [Actualizare monitor]. Plug an USB stick with the new version of “AniM_INT.exe” provided by your Mdoloris Medical Systems representative. Then select [Actualizare monitor] (see figure 42 next page). MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...
  • Page 39 ANI Monitor V1 - Continuous analgesia monitoring system Figure 42 A message will appear to confirm the success of the updating (figure 43). After 5 seconds, press on [Revenire la monitorul ANI]. Figure 43 MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...
  • Page 40 ANI Monitor V1 - Continuous analgesia monitoring system If an USB stick isn’t plugged, a message will appear to inform the user (figure 44): Figure 44 If the “AniM_INT.exe” isn’t present on the USB stick, a message appears (figure 45): Figure 45 MD/PRD/IN16.ANIV1 V.10 –...

  • Page 41: Shutting Down The Ani Monitor V1

    ANI Monitor V1 - Continuous analgesia monitoring system 7.11 Shutting down the ANI Monitor V1 Pressing the button [ Oprire] (figure 33) ends the session and will shut down the ANI Monitor V1. NOTE: it is possible to shut down the monitor by pressing directly the switch located on bottom right hand corner of the front side (see figure 12) only if the context prevent you to reach the main menu (figure 34).

  • Page 42: Monitor Disposal

    10 Environnement 10.1 Shipping and Storage Environnement The ANI 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.

  • Page 43: Operating Environnement

    FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY OCCUR. The ANI Monitor V1 is designed to operate safely in a temperature from 5° to 40° C to an altitude of 2000m, in a humidity range from 15% to 95% (non-condensing) and a pressure from 360mm Hg to 800mm Hg.

  • Page 44: Care, Cleaning And Maintenance

    SURFACE SECTION SUPERIOR TO 0.75 mm². 11 Care, cleaning and maintenance 11.1 Care and Cleaning ANI Monitor V1 can support a thousand cleaning cycles. WARNING: UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. PUT CONTAMINATED MATERIALS IN REGULATED WASTE CONTAINER.

  • Page 45: Maintenance

    Leakage current is a primary indicator of electrical shock hazard to personnel making contact with any exposed outer surface of the equipment. Each ANI Monitor V1 is carefully checked at the factory to verify that leakage current meets the IEC60601-1 safety standards.

  • Page 46: Specifications, Warranty And Software License Agreement

    Manufacturer: IEI (product reference: AFL-08A-N270) Acquisition device: Mdoloris Medical Systems reference: BA-ANI-V1 Manufacturer: RHEA Electronique Sensors cable: Mdoloris Medical Systems reference: ANI-SC-V1 (ANI Sensor V1 / ANI Sensor V2) ; ANI-SC-V1PLUS (ANI Sensor V1 PLUS) Manufacturer: Axon Power cable: Mdoloris Medical Systems reference: ANI-PW-V1-x.

  • Page 47: Warranty

    ANI Monitor V1 - Continuous analgesia monitoring system Protection against the ingress of liquids: Be sure to install the ANI Monitor V1 (Screen and acquisition device) outside any area with a risk of blood or liquids ingress. System functioning: Continuous: operation under normal load for a normal period without exceeding the specified limits of temperature.
  • Page 48 Mdoloris Medical Systems ; or that have been disassembled, serviced, or reassembled by anyone other than Mdoloris Medical Systems, unless authorized by Mdoloris Medical Systems.

  • Page 49: Software License Agreement

    The computer software (“Licensed Software”) loaded on the ANI 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. You own the System, but Mdoloris Medical Systems retains all ownership rights and title to the Licensed Software itself.
  • Page 50 AND YOUR EXCLUSIVE REMEDY SHALL BE LIMITED TO THE MONEY PAID FOR THE SYSTEM, WHICH INCLUDED THE LICENSED SOFTWARE. IN NO EVENT SHALL MDOLORIS MEDICAL SYSTEMS BE LIABLE TO YOU (a) FOR ANY INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS...
  • Page 51 MDOLORIS MEDICAL SYSTEMS RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT. 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 MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

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