MDMS ANI Monitor V2 User Manual
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MDMS ANI Monitor V2 User Manual

Continuous analgesia monitoring system
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ANI Monitor V2 - Continuous analgesia monitoring system
User manual
ANI Technology
ANI Monitor V2
Software version: V2.2.1.0
1370
(CE mark first approved: February 2017)
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.ANIV2 v.07 - 12 MAR 2020

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  • Page 1 ANI Monitor V2 - Continuous analgesia monitoring system User manual ANI Technology ANI Monitor V2 Software version: V2.2.1.0 1370 (CE mark first approved: February 2017) MDOLORIS MEDICAL SYSTEMS SAS Biocentre Fleming Bâtiment C Epi de Soil 270 rue Salvador Allende...
  • Page 2 ANI is a protected trademark. Important information about the intended use of ANI Monitor V2: The Mdoloris Medical Systems’ ANI Monitor V2 is designed to be used for adult and paediatric patients from the age of 2 years. ANI Monitor V2 is intended for use under the direct supervision of a licensed...

  • Page 3: Table Of Contents

    ANI Sensor V1 / ANI Sensor V2 / ANI Sensor V1 PLUS ......... 12 ANI Monitor V2 Connection ................. 14 Beginning ANI Monitor V2 ..................15 Using the ANI Monitor V2 and setting parameters ..........17 ECG Capture ......................17 Respiratory pattern....................18 ANI index.......................
  • Page 4 ANI Monitor V2 - Continuous analgesia monitoring system 10.1 Shipping and storage conditions ................ 37 10.2 Operating environment ..................38 10.3 Power requirements and grounding ..............38 11 Cleaning and disinfection ..................38 11.1 Cleaning ........................ 38 11.2 Maintenance ......................39 12 Specifications, warranty and software license contract ........

  • Page 5: Safety Precautions

    NEITHER THE MONITOR NOR THE ELECTRODES ARE DESIGNED FOR USE IN A MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT. THIS ANI Monitor V2 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 6 INCREASED ELECTROMAGNETIC EMISSIONS DECREASED ELECTROMAGNETIC IMMUNITY OF THE ANI Monitor V2 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 7 ANI Monitor V2 - Continuous analgesia monitoring system DO NOT PLACE THE SKIN ELECTRODES BETWEEN DEFIBRILLATOR PADDLES WHEN THEY ARE USE ON A PATIENT CONNECTED TO THE ANI Monitor V2. ELECTRICAL SHOCK: - DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET HANDS.
  • Page 8 HAZARD ZONE, E.G. PERFUSION BAG. NEVER MODIFY THE MONITOR WHEN OPEN. THE CHARACTERISTICS OF ANI Monitor V2 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), ANI Monitor V2 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION OF RADIO FREQUENCY COMMUNICATION.
  • Page 9 ANI Monitor V2 - Continuous analgesia monitoring system THE PATIENT SHOULD NOT BE ABLE TO REACH THE EQUIPMENT DIRECTLY OR INDIRECTLY; AVOID FOR INSTANCE PLACING EQUIPMENT ON TOP OF ANOTHER EQUIPMENT WITH A METAL CASING. TO REMOVE POWER SUPPLY FROM THE MONITOR, UNPLUG THE POWER CABLE.

  • Page 10: Key To Symbols

    ANI Monitor V2 - Continuous analgesia monitoring system Key to symbols Symbol Description Symbol Description Manufacturer + Fragile; handle with care Manufacturing Date Direct current, DC Serial number BF Type equipment, protects Class II equipment against defibrillation Caution: Federal law restricts...

  • Page 11: Ani Monitor V2

    ANIm lower than 50 makes hemodynamic reactivity very likely in the following 10 minutes. ANI calculation is based on R-R interval variability in ECG. Since the ANI Monitor V2 is not an ECG or a cardiac monitor, the electrodes have been designed to retrieve information related to QRS complexes.

  • Page 12: Installating The Ani Monitor V2

    Installating the ANI Monitor V2 Perfusion stand Position the ANI Monitor V2 so that the main power supply can be easily plugged in. The monitor can be installed on a perfusion stand by using a specific "pole clamp", which fit pole diameters ranging from 19 to 38 mm.
  • Page 13 Sensors’ positionning NOTE: The ANI Monitor V2 has been designed to work with specific disposable sensors. It is inadvisable to use another kind of electrode. The maximum consecutive period that the electrodes can adhere to the skin is 24 hrs.

  • Page 14: Ani Monitor V2 Connection

    ANI Monitor V2 - Continuous analgesia monitoring system ANI Monitor V2 Connection Connect the sensors to the sensor cable then connect it to the monitor. Before connecting, carefully align the notches on the connection sheet to make the pins correspond perfectly. To disconnect the electrodes, grasp the plastic portion while pressing on the locking mechanism and pull gently to disengage it.

  • Page 15: Beginning Ani Monitor V2

    ANI Monitor V2 - Continuous analgesia monitoring system SENSOR SENSOR CABLE ANI Sensor V1 ANI-SC-V2 ANI-SENS-V1 ANI Sensor V2 ANI-SC-V2 ANI-SENS-V2 ANI Sensor V1 PLUS ANI-SC-V2PLUS ANI-SENS-V1PLUS Beginning ANI Monitor V2 After connecting the monitor to the electrical socket, press the touch-sensitive switch situated at the bottom centre of the screen.
  • Page 16 ANI Monitor V2 - Continuous analgesia monitoring system Main menu Once the monitor is connected to the patient with the electrodes, the calculation algorithm will automatically begin. Note: The ANI technology can be used with both conscious and unconscious patients, whenever the physician wishes to use it.

  • Page 17: Using The Ani Monitor V2 And Setting Parameters

    ANI Monitor V2 - Continuous analgesia monitoring system 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 18: Respiratory Pattern

    ANI Monitor V2 - Continuous analgesia monitoring system Case n°2 – Medium signal quality When the signal quality is medium (yellow or orange indication is lit), the user is warned that the signal quality may become worse soon. Case n°3 – Poor signal quality If the indication shows poor signal quality (red indication is lit) the data displayed cannot be takin into account.

  • Page 19: Ani Index

    ANI Monitor V2 - Continuous analgesia monitoring system ANI index We have developed calculation algorithms based on the amplitude measurement of the respiratory modulation of RR interval time series. A continuous index is displayed (each basic measurement is performed on 64 seconds of data with a sliding window every second) that reflects the parasympathetic tone of the patient.

  • Page 20: Ani Navigation

    ANI Monitor V2 - Continuous analgesia monitoring system Curves If R waves are not correctly detected, ANI measurements are not displayed until ECG detection is correct again. ANI navigation Selecting « ANI navigation » under the index window will open a navigation window in which the user can scroll through the ANI measurements and see the events captured.

  • Page 21: Threshold

    ANI Monitor V2 - Continuous analgesia monitoring system Threshold As shown in the screen below (figure 23), threshold values can be set here. Select «Enable threshold». Enable threshold Default values appear below in the data input (50/70). Click on the first input field and enter a first threshold value. Click on «Validate» to validate.
  • Page 22 ANI Monitor V2 - Continuous analgesia monitoring system Input data If the user confirms without entering data, he will be asked to insert a value between 0 and 100. Once data have been entered, click “VALIDATE”. P a g e 22 | 45 MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020...

  • Page 23: Events

    ANI Monitor V2 - Continuous analgesia monitoring system Threshold zone Events As shown in the screen below, 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. Click one of these buttons to insert a line through the ANI curve and the event will be recorded in the R-R series log.

  • Page 24: Expert Mode And Energy Index

    ANI Monitor V2 - Continuous analgesia monitoring system • • • ok breathing extubation cough • • • trble breathing no stimulation reinject opioids • • • induction surg stimulation reinject hypnotic • • • VAS = … awakening hemo reaction •...
  • Page 25 ANI Monitor V2 - Continuous analgesia monitoring system Sudden drop of the instantaneous • « Expert » mode: display of respiratory pattern and an additional function called: «Energy» index. P a g e 25 | 45 MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020...
  • Page 26 ANI Monitor V2 - Continuous analgesia monitoring system Expert mode 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 ...

  • Page 27: Ending Ani Monitoring

    If you respond « Yes », the ANI Monitor displays the main menu: Demo Selecting «Demo» at the top left, displays a video of the ANI Monitor V2 operating. New patient Selecting «New patient» initializes monitoring and launches a new patient monitoring session, as well as a new set of exportable data files.

  • Page 28: Maintenance

    ANI Monitor V2 - Continuous analgesia monitoring system Maintenance Selecting « Maintenance » opens a window with an input field. Access to this area is protected by a code that will be sent to you by Mdoloris Medical Systems if you request it.
  • Page 29 ANI Monitor V2 - Continuous analgesia monitoring system The user can select the files to be exported by selecting “Export Selection” or can export all of the files by selecting “Export Totality”. If the monitor does not detect the USB drive (no drive present, or inserted incorrectly), a message is displayed to indicate this («...
  • Page 30 ANI Monitor V2 - Continuous analgesia monitoring system Expert mode P a g e 30 | 45 MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020...
  • Page 31 ANI Monitor V2 - Continuous analgesia monitoring system Classic Mode Date format DD/MM/YYYY Time Format of the time HH:MM:SS Time(s) Sampling in seconds Energy Signal Energy Instantaneous value of the ANI between 0 and 100 (Expert Mode) ANImean Averaged value of the ANI between 0 and 100...

  • Page 32: Updating Events

    ANI Monitor V2 - Continuous analgesia monitoring system Real time data from the monitor can be retrieved by connecting a computer to the “real-time export” port on the right side of the monitor. The character string can be displayed by a terminal type software application (to get the protocol available in the technical manual, please contact your Mdoloris agent).

  • Page 33: Setting Date And Time

    ANI Monitor V2 - Continuous analgesia monitoring system To add new events to the list, use the virtual keyboard on the touchscreen then select « √ Validate ». The character limit is 18 characters. 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.

  • Page 34: Updating Monitor

    ANI Monitor V2 - Continuous analgesia monitoring system Use the arrows to select the desired change. Validate the changes before closing the window by selecting «Apply». Select «X» to close the window. 7.10 Updating monitor In the main menu, click on « Update monitor». Connect a USB key with the new version of “ANI_V2.exe”...

  • Page 35: Shutting Down

    ANI Monitor V2 - Continuous analgesia monitoring system A message will appear to confirm that the update was successful. After 5 seconds, click on « Return to the ANI monitor». If there is no USB key connected, a message will appear to tell the user (Insert a USB key).

  • Page 36: Trouble Shooting

    ANI Monitor V2 - Continuous analgesia monitoring system 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) but only if the context does not allow you to reach the main menu.

  • Page 37: Monitor Disposal

    In this respect, Mdoloris Medical Systems fulfils its obligations concerning the end- of-life of the ANI Monitor V2 that it places on the market by financing the DEEE Pro recycling system that collects and recycles free of charge (For more information contact your Mdoloris...

  • Page 38: Operating Environment

    The ANI Monitor V2 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 39: Maintenance

    11.2 Maintenance The ANI Monitor V2 is designed so that no periodic maintenance is required. Leakage current is a primary indicator of electrical shock hazard for personnel who touches any of the device's outer surfaces. Static electricity tests have been conducted on our monitor to ensure that the leakage current meets safety standards IEC 60601-1.

  • Page 40: Specifications, Warranty And Software License Contract

    Protection against the projection of liquids: Always ensure that ANI Monitor V2 is placed away from any area that would be at risk from blood or solute spillage. System operation: Continuously: operation at a normal load for a normal duration, not exceeding the temperature limits set.

  • Page 41: Accessories

    ANI Monitor V2 - Continuous analgesia monitoring system 12.2 Accessories Number Identification ANI Monitor V2 Sensor End User Cable Power cord AC/DC Power supply Pole clamp P a g e 41 | 45 MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020...

  • Page 42: Warranty

    ANI Monitor V2 - Continuous analgesia monitoring system 12.3 Warranty Mdoloris Medical Systems warrants to the initial Purchaser that the ANI Monitor V2 (“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 43: Software License Agreement

    WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. 12.4 Software License Agreement The computer software (“Licensed Software”) loaded on the ANI Monitor V2 (“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 44 ANI Monitor V2 - Continuous analgesia monitoring system 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 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 45 ANI Monitor V2 - Continuous analgesia monitoring system permissible and the remaining provisions of this Agreement will remain in full force and effect. Should you have any questions concerning this License Agreement, you may contact your Mdoloris Medical Systems representative.

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