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Mdoloris ANI Monitor V1 User Manual

Continuous analgesia monitoring system
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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
MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020

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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 Monitor needs special precautions regarding environments. The ANI Monitor V1 has to be installed and put into service in hospitals and away from the RF source magnetic resonance imaging. ANI is a protected trademark. MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...

  • Page 3: Table Of Contents

    ANI Sensor V1 / ANI Sensor V2 / ANI Sensor V1 PLUS ........11 ANI Monitor V1 connection ................... 13 Battery ........................14 Beginning ANI Monitoring ..................15 Using the ANI Monitor V1 and setting parameters ........... 17 ECG Capture ......................17 Respiratory pattern ....................18 ANI index ....................... 19 ANI navigation .......................
  • Page 4 ANI Monitor V1 - Continuous analgesia monitoring system Monitor disposal ......................36 10 Environment ........................ 36 10.1 Shipping and storage conditions ................36 10.2 Operating Environment ................... 37 10.3 Power requirements and grounding ................. 37 11 Cleaning and disinfection .................... 38 11.1 Cleaning .........................

  • Page 5: Safety Precautions

    NOTE 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. Warning GROUND LEAKAGE CURRENT MUST BE CHECKED BY A QUALIFIED BIOMEDICAL ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED.
  • Page 6 MAY OCCUR. NEITHER THE MONITOR NOR THE ELECTRODES ARE DESIGNED FOR USE IN A MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT. THIS ANI Monitor V1 CANNOT BE IN ANY CASE CONSIDERED AS AN ECG MONITORING SYSTEM. WHEN USING ELECTRO-CONVULSIVE THERAPY (ECT) EQUIPMENT DURING ANI MONITORING: place ECT electrodes as far away as possible from the sensor to minimize the effect of interference.
  • Page 7 THE MANUFACTURER OF THE ANI Monitor V1 (MDOLORIS MEDICAL SYSTEMS) MAY RESULT IN INCREASED ELECTROMAGNETIC EMISSIONS OR DECREASED ELECTROMAGNETIC IMMUNITY OF THE ANI Monitor V1 AND MAY RESULT IN AN INAPPROPRIATE OPERATION. CONSIDERATION RELATING TO THE CHOICE OF EQUIPMENT SHALL...
  • Page 8 INTERFACE CABLE MUST BE CAREFULLY PLACED AND SECURED. DO NOT PLACE THE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADDLES WHEN THEY ARE USE ON A PATIENT CONNECTED TO THE ANI Monitor V1. REUSING A SENSOR ALREADY USED ON ANOTHER PATIENT COULD LEAD TO CROSS-CONTAMINATION.
  • Page 9 WHEN A BIOMEDICAL ENGINEERING TECHNICIAN PERIODICALLY PERFORMS MAINTENANCE. WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR LIQUIDS OCCURS ON THE ANI Monitor V1, RE-TEST GROUND LEAKAGE CURRENT BEFORE FURTHER USE. OBSERVE UNIVERSAL PRECAUTIONS TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS.

  • Page 10: 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 ANI Monitor V1, INCLUDING CABLES SPECIFIED BY THE MANUFACTURER. OTHERWISE, DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD RESULT.
  • Page 11 Reusing a sensor could reduce its adhesion. The ANI Monitor V1 should not be used near or placed on top of another electrical equipment. If however this is unavoidable, check regularly that the ANI Monitor V1 operates properly in this configuration.

  • Page 12: Notes

    ANI Monitor V1 will switch off automatically. After reconnecting the ANI Monitor V1 to the main power supply, press the power switch on the front side of the monitor. In case the monitor does not start, press the switch at the back of the monitor in order to reboot the device.

  • Page 13: Ani Monitor V1

    2 ANI Monitor V1 Indications for use: The Mdoloris Medical Systems SAS ANI Monitor V1 is intended to acquire, display, and analyze electrocardiographic information and to measure-heart rate variability. These and other measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV and other parameters must be determined by the physician.
  • Page 14 The ANI Monitor V1 displays two averaged ANI measurements: ANIi results from the average of ANI measured over the last 120 sec, and ANIm results from the average of ANI measured over the last 240 sec.

  • Page 15: Installing The Ani Monitor V1

    Installing the ANI Monitor V1 Perfusion stand Position the ANI Monitor V1 in order for the main power supply to be easily plugged in. The monitor can be installed on a perfusion stand (figure 1) by using a specific "pole clamp", which fit pole diameters ranging from 19 to 38 mm.
  • Page 16 ANI Monitor V1 - Continuous analgesia monitoring system Conductive gel Adhesive portion Figure 2 Figure 3 The principle of this two-part device is to place it 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: Ani Monitor V1 Connection

    ANI Monitor V1 - Continuous analgesia monitoring system NOTE: The ANI Monitor V1 has been designed to work with specific disposable sensors. It is inadvisable to use another kind of electrode. Electrodes are packaged ten per bag. New electrodes can be purchased in boxes of ten bags i.e.

  • Page 18: Battery

    The ANI index is still calculated during this time. NOTE: plug the ANI Monitor V1 on the main power supply before trying to switch it on. MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...

  • Page 19: Beginning Ani Monitoring

    ANI Monitor V1 will switch off automatically. After reconnecting the ANI Monitor V1 to the main power supply, press the power switch on the front side of the monitor (figure 12). In case the monitor does not start, press the switch at the back of the monitor (figure 13) in order to reboot the device.
  • Page 20 Rear power switch Figure 13 The monitor will start by showing the Mdoloris Medical Systems logo animations successively. The screen will then show the start page automatically, indicating “Calibration” on the central screen (figure 14). The first ANI measurement will take at least 80 seconds. No data can be interpreted before this initialization time lapse.

  • Page 21: Using The Ani Monitor V1 And Setting Parameters

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 15 Check for good ECG signal quality in the lower part of the screen. If there is no signal, check the connection between the monitor and the electrodes. Try at least once to unplug and plug in the connection again to recover the ECG signal.

  • Page 22: Respiratory Pattern

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 16 Respiratory pattern The surface area generated by "respiratory patterns" in the R-R series is measured and displayed in a hatched surface (figures 17 and 18). The higher the surface, the stronger the relative p...

  • Page 23: Ani Index

    ANI Monitor V1 - Continuous analgesia monitoring system ANI index Mean ANI Instantaneous ANI Figure 19 In the neighboring window two trends of ANIi and ANIm are displayed (yellow and orange) (figure 20). Figure 20 If R waves are not correctly detected, ANI measurements are not displayed until ECG detection is correct again.

  • Page 24: Ani Monitor V1 Settings

    ANI Monitor V1 - Continuous analgesia monitoring system Select [X] to close this window. Signal acquisition is not disturbed while the navigation window is opened. ANI Monitor V1 settings To access the settings described in this section, select [Parameters] on the bottom right of the screen during monitoring.
  • Page 25 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 enter a first threshold value (figure 25). Click on [Validate] to validate.
  • Page 26 ANI Monitor V1 - Continuous analgesia monitoring system Figure 26: example with two threshold values captured Figure 26 Figure 27: Threshold values Figure 27 MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...

  • Page 27: Events

    ANI Monitor V1 - Continuous analgesia monitoring system Events As shown in the screen below (figure 28), in the menu you can insert clinical events so that they can be visible in the trend window and be recorded in the exportable data file.
  • Page 28 ANI Monitor V1 - Continuous analgesia monitoring system Figure 29 • "Expert mode": display of respiratory pattern and an additional function called “Energy” (figure 30) Figure 30 MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...
  • Page 29 ANI Monitor V1 - Continuous analgesia monitoring system The Energy index is equivalent to the total spectral power of the autonomous nervous system. When the value of the Energy index varies out of the range [0.05 – 2.5], it means that the ANI calculated at this specific moment is probably influenced by other conditions than the patient’s...

  • Page 30: Ending Ani Monitoring

    Figure 32 Note: if you respond [Yes] you will not be able to return to the current patient. If you respond [Yes], the ANI Monitor V1 displays the main menu (figure 33): Figure 33 MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...

  • Page 31: Demo

    Maintenance Selecting [Maintenance] (figure 33) opens a window with an input field (see figure 34). Access to this area is protected by a code that will be sent to you by Mdoloris Medical Systems if you request it. Figure 34 Deleting patient data Selecting [Empty] (figure 33) erases all the data stored previously.

  • Page 32: Screen Capture

    ANI Monitor V1 - Continuous analgesia monitoring system Figure 35 Once all data has been deleted, another window appears for confirmation (figure 36). Select [OK] to return to the main menu (figure 33). Figure 36 Screen capture When the user selects [Screen capture], the information on the screen is saved in image format in the monitor's internal memory.

  • Page 33: Exporting Data Files

    ANI Monitor V1 - Continuous analgesia monitoring system Exporting data files Select the button [Export] (figure 33) to transfer all the data stored in the monitor's memory to a USB drive that is in the USB port called "Data Export" located on the monitor's side. If the monitor does not detect the USB drive (no drive present, or inserted incorrectly), a message is displayed to indicate this (figure 38).

  • Page 34: Updating Events

    ANI Monitor V1 - Continuous analgesia monitoring system interruption in recording as an event so that this error is taken into account later when data is processed. Updating events As explained above (see section 7.3), events corresponding to different clinical moments are predefined in the system.

  • Page 35: Setting Date And Time

    ANI Monitor V1 - Continuous analgesia monitoring system The new event is then added to the event-list displayed on the right. Use the scroll bar if the added event does not appear. An event can be removed from the list by touching it, and selecting [Remove].

  • Page 36: Updating Monitor

    ANI Monitor V1 - Continuous analgesia monitoring system 7.10 Updating monitor In the main menu (figure 33), click on [Update monitor]. Connect a USB key with the new version of “AniM_INT.exe” provided by your Mdoloris Medical Systems representative. Next, select [Update monitor] (figure 42). Figure 42 A message will appear to confirm that the update was successful (figure 43).
  • Page 37 ANI Monitor V1 - Continuous analgesia monitoring system Figure 44 If the file “AniM_INT.exe” is not present on the USB key, a message will appear (figure 45): Figure 45 MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020...

  • Page 38: Shutting Down

    ANI Monitor V1 - Continuous analgesia monitoring system 7.11 Shutting down [Shutdown] (figure 33) switches off the ANI Monitor V1. Selecting NOTE: it is also possible to switch off the monitor directly by pushing the switch on the front (the same one as to turn it on. See figure 12) but only if the context does not allow you to reach the main menu.
  • Page 39 ANI Monitor V1 - Continuous analgesia monitoring system Problem Solution Check that the battery's power indicator is on (figure 13) when the monitor is connected to a The monitor doesn’t boot. power supply. If the power indicator is off, remove the transparent cover and push the button.

  • Page 40: Monitor Disposal

    10 Environment 10.1 Shipping and storage conditions The ANI Monitor V1 and its accessories can be stored or shipped within the following environmental limits. These limits apply to non-operational storage and shipping situations. Temperature: -20°C to +60°C...

  • Page 41: Operating Environment

    The ANI Monitor V1 is designed to operate safely at a temperature from 5°C to 40°C and at up to 2000 m altitude. Conditions outside these limits could make it less reliable.

  • Page 42: Cleaning And Disinfection

    ANI Monitor V1 - Continuous analgesia monitoring system 11 Cleaning and disinfection 11.1 Cleaning The ANI Monitor V1 can support 1,000 cleaning cycles. WARNING: OBSERVE UNIVERSAL PRECAUTIONS TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS. PUT CONTAMINATED MATERIALS IN THE APPROPRIATE CONTROLLED WASTE CONTAINERS.

  • Page 43: Maintenance

    11.2 Maintenance The ANI 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 44 Manufactured by IEI (product reference: AFL-08A-N270) Acquisition case: Mdoloris Medical Systems Ref: BA-ANI-V1 Manufactured by RHEA Electronique Sensor cable: Mdoloris Medical Systems Ref: ANI-SC-V1 (ANI Sensor V1/ANI Sensor V2) ; ANI-SC-V1PLUS (ANI Sensor V1 PLUS) Manufactured by AXON Power cable: Mdoloris Medical Systems Ref: ANI-PW-V1-x.

  • Page 45: Warranty

    ANI Monitor V1 - Continuous analgesia monitoring system Take care to always position the ANI Monitor V1 (screen and acquisition device) outside any area that would be at risk of having blood or liquids spill on it. System operation: Continuously: operation at a normal load for a normal duration, not exceeding the temperature limits set.
  • Page 46 Medical Systems shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. Mdoloris Medical Systems makes no warranty (a) with respect to any products that are not Warranted Products, (b) with respect to...

  • Page 47: 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 48 ANI Monitor V1 - Continuous analgesia monitoring system 3. TERMINATION: this License remains effective until terminated. This License will terminate automatically without notice from Mdoloris Medical Systems if you fail to comply with any term or provision of this License. Upon termination of this License, you may not make any further use of the Licensed Software.
  • Page 49 Mdoloris Medical Systems representative. THIS LICENSE AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN YOU AND MDOLORIS MEDICAL SYSTEMS For any incident, please report to Mdoloris Medical Systems at service.qualite@mdoloris.com AND SUPERSEDES ANY PROPOSAL OR PRIOR AGREEMENT, ORAL OR...

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