Mdoloris ANI V1 User Manual
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Mdoloris ANI V1 User Manual

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Continouous 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 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 - Continouous analgesia monitoring system ©Mdoloris Medical Systems. All rights reserved. Copying or other reproduction of this document is prohibited without prior written consent of Mdoloris Medical Systems. ANI is a registered trademark. Important information about using continuous analgesia monitoring system: The Mdoloris Medical Systems’...

  • Page 3: Table Of Contents

    ANI Monitor V1 - Continouous analgesia monitoring system Table of contents 1 Safety precautions ......................5 Warnings ........................5 Cautions ........................10 Notes .......................... 12 Key to Symbols ......................12 ANI monitor presentation ....................13 ANI monitor installation ....................14 Clamping support ......................
  • Page 4 ANI Monitor V1 - Continouous analgesia monitoring system 11.1 Care and Cleaning ....................... 44 11.2 Maintenance ......................... 45 11.3 Leakage Current ......................46 12 Specifications, warranty and software license agreement ........... 46 12.1 Specifications ....................... 46 12.2 Warranty ........................47 12.3 Software License Agreement ..................

  • Page 5: Safety Precautions

    ANI Monitor V1 - Continouous analgesia monitoring system 1 Safety precautions INTRODUCTION: Caution: carefully read this entire manual before using the monitor in a clinical setting. WARNINGS, CAUTIONS AND NOTES The terms warning, caution, and note have specific meanings in this manual. •...
  • Page 6 ANI Monitor V1 - Continouous 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 ANI Monitor V1 - Continouous analgesia monitoring system THE USE OF ACCESSORY EQUIPMENT NOT COMPLYING WITH THE MANUFACTURERS REQUIREMENTS MAY INFLUENCE THE SAFETY OF THE RESULTING SYSTEM. CONSIDERATION RELATING TO THE CHOICE OF EQUIPMENT SHALL INCLUDE: - USE OF THE ACCESSORY IN THE PATIENT VICINITY AND OR SURGERY VICINITY - EVIDENCE THAT THE SAFETY CERTIFICATION «...
  • Page 8 ANI Monitor V1 - Continouous analgesia monitoring system OF RADIO FREQUENCY COMMUNICATION. THE USER MIGHT NEED TO PERFORM CORRECTIVE ACTIONS, SUCH AS REIMPLANTATION OR REORIENTATION OF THE ANI Monitor V1. THE INTERFACE WIRE HAS TO BE CAREFULLY PLACED AND HELD DOWN TO PREVENT ANY PATIENT STRANGULATION RISK.
  • Page 9 OR BE AFFECTED BY OTHER EQUIPMENT IN THE VICINITY DUE TO ELECTROMAGNETIC INTERFERENCE (EMI). IF THIS OCCURS: - INCREASE SEPARATION BETWEEN DEVICES - CHANGE THE ORIENTATION OF DEVICE CABLING - PLUG DEVICES INTO SEPARATE CIRCUIT OUTLET OR PLEASE CONTACT YOUR MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE. MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

  • Page 10: Cautions

    ANI Monitor V1 - Continouous analgesia monitoring system THE ANI Monitor V1 IN OPERATING SURGICAL ROOM MUST BE PLACED OUTSIDE THE SAFETY CONE OF EXPLOSION RISK. TO AVOID THE HAZARD OF BURNS BE SURE THE MONITOR IS INSTALLED OUTSIDE THE SURGICAL SECURITY AREA AND AS FAR AS POSSIBLE FROM LIQUID INGRESS TO PREVENT SYSTEM DAMAGE.
  • Page 11 The ANI Monitor V1 contains an internal battery. This battery must be removed by an authorized technician and discarded or recycled in accordance with national regulatory in force in the country. Contact Mdoloris Medical Systems or the local distributor for the battery maintenance.

  • Page 12: Notes

    ANI Monitor V1 - Continouous 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 Presentation

    ANI Monitor V1 - Continouous 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 Installation

    ANI Monitor V1 - Continouous analgesia monitoring system • variable tidal volume during the measurement period (64 seconds) • 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.
  • Page 15 ANI Monitor V1 - Continouous analgesia monitoring system Figure 1 ANI Sensor V1 / ANI Sensor V2 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 ANI Monitor V1 - Continouous analgesia monitoring system The principle of this patch in two parts is to be placed on each side of the heart (thus on each side of the chest) to get a cardiac vector (the axis of the average cardiac vector according to the reference anatomical position is: forward, down and left).

  • Page 17: Skin Electrodes

    24hrs. The electrodes shelf-life is noted on the outer white pouch: in a closed white pouch, it is two years. In an opened white pouch, the electrodes shelf-life is six months. The biocompatibility has been made on every Mdoloris Medical Systems’ array. They match with ISO10993-5 and 10993-10.

  • Page 18: Battery

    ANI Monitor V1 - Continouous analgesia monitoring system Figure 10 Figure 11 Battery 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.

  • Page 19: Beginning The Ani Monitoring

    ANI Monitor V1 - Continouous 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. 4 Beginning the ANI monitoring Ignite the monitor thanks to the switch in the bottom right hand corner of the front side (figure 12).
  • Page 20 ANI Monitor V1 - Continouous analgesia monitoring system 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. The screen will then indicate “Calibration” (figure 14).
  • Page 21 ANI Monitor V1 - Continouous 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. Please try once to unplug and plug again the acquisition device to recover the ECG signal.

  • Page 22: Ani Computing Process

    ANI Monitor V1 - Continouous 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 - Continouous 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 - Continouous 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 Setup

    ANI Monitor V1 - Continouous 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 [Parametreler] 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 - Continouous analgesia monitoring system Figure 24 If you click on the [X] button without capturing the threshold values, a new window will appear (figure 25): click on [TAMAM]. Figure 25 Click on the first input field and capture a first threshold value (figure 26). Click on [Onayla] to validate.
  • Page 27 ANI Monitor V1 - Continouous analgesia monitoring system Figure 26 Figure 27: example with the two captured threshold values Figure 27 MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

  • Page 28: Events Insert

    ANI Monitor V1 - Continouous analgesia monitoring system Figure 28: Threshold values Figure 28 Events insert As shown in the screen below (figure 29), 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 - Continouous analgesia monitoring system An example of a file’s content is given below: Figure 29 • ok breathing • extubation • cough • trble breathing • no stimulation • re-inject morphinic • induction • surg stimulation •...
  • Page 30 ANI Monitor V1 - Continouous analgesia monitoring system Figure 30 • “Expert” mode which displays respiratory pattern and one more function called “Energy” (figure 31) MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...
  • Page 31 ANI Monitor V1 - Continouous analgesia monitoring system Figure 31 The Energy index is equivalent to the “total spectral power of the autonomous nervous system”. When the value of the Energy index varies dramatically, it means that the ANI calculated at this specific moment is not significant of the patient’s parasympathetic tone value.

  • Page 32: Operating The Ani Monitor

    ANI Monitor V1 - Continouous analgesia monitoring system Figure 32 7 Operating the ANI Monitor V1 Quit Patient Pushing the button [Durdur] 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 33).

  • Page 33: Demo

    Maintenance Selecting [Bakım] (figure 34) opens a window with an input field (see figure 35 next page). This access is protected by a code that will be forwarded on request to Mdoloris Medical Systems. MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

  • Page 34: Delete Patients Data

    ANI Monitor V1 - Continouous analgesia monitoring system Figure 35 Delete patients data Pressing the button [Temizle] deletes all data previously computed and saved. A first window will ask for confirmation of this action (figure 36). Figure 36 When all data are deleted, another window will appear to confirm that the action is done (figure 37).

  • Page 35: Screen Shot

    ANI Monitor V1 - Continouous analgesia monitoring system Figure 37 Screen shot When the user pushes on the button [Ekran Görüntüsü], the information displayed are saved in the monitor’s memory as picture format. Each time the user decides to get a screen shot, one picture will be saved in the monitor’s memory.
  • Page 36 ANI Monitor V1 - Continouous analgesia monitoring system Figure 39 At the end of this step, a message will appear to confirm the success of the export (figure 40). Press the button [TAMAM] to back to the main menu. Figure 40 Note: Data are automatically saved into a file including the date and hour on the monitoring started.

  • Page 37: Update Of Events

    ANI Monitor V1 - Continouous analgesia monitoring system Update of events As explained previously (see chapter 7.3), events corresponding to several clinical moments are predefined in the system. The list can be modified by the user in order to provide displayed marks on the ANI trend panel and in the recorded variables, for further analysis.

  • Page 38: Date And Time Settings

    7.10 Update monitor In the main menu, select [Monitörü Güncelle]. Plug an USB stick with the new version of “AniM_INT.exe” provided by your Mdoloris Medical Systems representative. Then select [Monitörü Güncelle] (see figure 43 next page). MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...
  • Page 39 ANI Monitor V1 - Continouous analgesia monitoring system Figure 43 A message will appear to confirm the success of the updating (figure 44). After 5 seconds, press on [ANI Monitör e geri dön]. Figure 44 If an USB stick isn’t plugged, a message will appear to inform the user (figure 45): MD/PRD/IN16.ANIV1 V.10 –...
  • Page 40 ANI Monitor V1 - Continouous analgesia monitoring system Figure 45 If the “AniM_INT.exe” isn’t present on the USB stick, a message appears (figure 46): Figure 46 MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021...

  • Page 41: Shutting Down The Ani Monitor

    Reboot the monitor thanks to the switch on the front side. If the problem continues, The Mdoloris Medical Systems software please contact your Mdoloris Medical does not start when the monitor is booted. Systems representative.

  • Page 42: Monitor Disposal

    ANI Monitor V1 - Continouous analgesia monitoring system Check the power indicator is bright (figure 13) when the monitor is connected to power The monitor doesn’t boot. supply. If the power indicator is dim, lift up the transparent shell and push on the button. Monitor disposal WARNING: to avoid any kind of contamination or infection on persons, on environment or on equipment, be sure you have properly disinfected and decontaminated the monitor before...

  • Page 43: Environnement

    ANI Monitor V1 - Continouous analgesia monitoring system 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 44: Power Requirements And System Grounding

    ANI Monitor V1 - Continouous analgesia monitoring system 10.3 Power Requirements and System Grounding The ANI Monitor V1 requires a power source of 100-240 VAC, 50-60Hz. Current consumption is 0.7 ampere maximum. To protect operating personnel and patients, the monitor must be properly grounded. Accordingly, the monitor is equipped with a hospital grade line cord.

  • Page 45: Maintenance

    ANI Monitor V1 - Continouous analgesia monitoring system Cleaning the monitor display: clean the monitor display screen with a mild solution of detergent and warm water or a commercial display screen cleaner, available through personal computer dealers. To avoid scratching the screen, never use abrasive cleaners. Disinfecting the monitor and acquisition device: Use lint-free absorbent towels dampened with a 10% bleach solution, or a commercial disinfectant.

  • Page 46: Leakage Current

    The efficacy and security of the products are warranted during the life time of the products (5 years from the manufacturing date). Material included in the ANI Monitor V1: Panel PC: Mdoloris Medical Systems reference: MN-ANI-V1 Manufacturer: IEI (product reference: AFL-08A-N270) Acquisition device: Mdoloris Medical Systems reference: BA-ANI-V1 Manufacturer: RHEA Electronique MD/PRD/IN16.ANIV1 V.10 –...

  • Page 47: Warranty

    - IIa Electro-Medical Equipment 12.2 Warranty Mdoloris Medical Systems warrants to the initial Purchaser that the ANI Monitor V1 and the acquisition device (“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 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 ANI Monitor V1 - Continouous analgesia monitoring system Software or its related documentation without the prior written consent of Mdoloris Medical Systems. The Licensed Software contains trade secrets and to protect them you may not decompile, reverse engineer, disassemble, or otherwise reduce the Licensed Software to a human-perceivable form.
  • 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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