Mdoloris ANI MONITOR V2 User Manual
  1. Manuals
  2. Brands
  3. Mdoloris Manuals
  4. Medical Equipment
  5. ANI MONITOR V2
  6. User manual

Mdoloris ANI MONITOR V2 User Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
ANI Monitor V2 - Continuous analgesia monitoring system
User manual
ANI Technology
ANI MONITOR V2
Software version: 2.2.2.0
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 – 29 SEP 2021

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the ANI MONITOR V2 and is the answer not in the manual?

Questions and answers

Related Manuals for Mdoloris ANI MONITOR V2

Summary of Contents for Mdoloris ANI MONITOR V2

  • Page 1 ANI Monitor V2 - Continuous analgesia monitoring system User manual ANI Technology ANI MONITOR V2 Software version: 2.2.2.0 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 healthcare practitioner or by personnel specifically trained for its use in a medical environment and non-sterile.

  • Page 3: Table Of Contents

    Table .......................... 11 ANI-SENS-V1 ......................12 ANI MONITOR V2 Connection ................13 Beginning ANI monitoring V2 ................... 14 Using the ANI MONITOR V2 and setting parameters ......... 16 ECG Capture ......................16 Respiratory pattern ....................17 ANI index ........................18 ANI navigation ......................
  • Page 4 ANI Monitor V2 - Continuous analgesia monitoring system 10.1 Shipping and storage conditions ................36 10.2 Operating environment ................... 37 10.3 Power requirements and grounding ..............37 11 Cleaning and disinfection ..................37 11.1 Cleaning ........................37 11.2 Maintenance ......................38 12 Specifications, warranty and software license contract ........

  • Page 5: Safety Precautions

    ENGINEERING TECHNICIAN WHENEVER INSTRUMENT CASE IS OPENED. PROTECTION AGAINST HEART DEFIBRILLATION SHOCK DEPENDS ON USING THE APPROPRIATE CABLES. EXPLOSION HAZARD: DO NOT USE THE ANI MONITOR V2 IN A FLAMMABLE ATMOSPHERE OR WHERE CONCENTRATIONS OF FLAMMABLE ANESTHETICS MAY OCCUR. NEITHER THE MONITOR NOR THE ELECTRODES ARE DESIGNED FOR USE IN A MAGNETIC RESONANCE IMAGING (MRI) ENVIRONMENT.
  • 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 Symbole Description Symbole 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

    Installing 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 12: Ani-Sens-V1

    Never put electrodes on skin injuries. Using electrode sensors other than those specified by Mdoloris Medical Systems can damage the device or result in a risk of harm to the user or the patient.

  • Page 13: Ani Monitor V2 Connection

    ANI Monitor V2 - Continuous analgesia monitoring system Sensors’ positionning NOTE: The ANI MONITOR V2 has been designed to work with specific disposable sensors (Ref. ANI-SENS-V1). 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: Beginning Ani Monitoring V2

    When the monitor is turned on, the LED lights up green. When the monitor is on stand-by mode, the LED lights up orange. The monitor will start displaying the Mdoloris Medical Systems logo animations successively. The screen will then, automatically display the start menu.
  • Page 15 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. Main view MD/PRD/IN16.ANIV2 v.07 – 29 SEP 2021 P a g e 15 | 44...

  • Page 16: 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 17: Respiratory Pattern

    ANI Monitor V2 - Continuous analgesia monitoring system You must try, at least once, to replace the sensor. 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.

  • Page 18: 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 19: 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 20: 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 21 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”. MD/PRD/IN16.ANIV2 v.07 – 29 SEP 2021...

  • Page 22: 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 23: 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 24 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. MD/PRD/IN16.ANIV2 v.07 – 29 SEP 2021 P a g e 24 | 44...
  • Page 25 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 26: 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 27: Maintenance

    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. Deleting patient data Selecting «Empty» erases all the data stored previously. You will be asked to confirm that you want to erase the records (Do you really want to delete all of the recordings?).
  • Page 28 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 29 ANI Monitor V2 - Continuous analgesia monitoring system Expert mode MD/PRD/IN16.ANIV2 v.07 – 29 SEP 2021 P a g e 29 | 44...
  • Page 30 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 31: Updating Events

    ANI Monitor V2 - Continuous analgesia monitoring system Quality Quality of the signal. Values ranging from 0 to 3 - 0 = bad signal quality - 1 = average signal quality - 2 = average signal quality - 3 = good signal quality...

  • Page 32: 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 33: Updating Monitor

    7.10 Updating monitor In the main menu, click on « Update monitor». Connect a USB key with the new version of “ANI_V2.exe” provided by your Mdoloris Medical Systems representative. Next, select « Update monitor». MD/PRD/IN16.ANIV2 v.07 – 29 SEP 2021...
  • Page 34 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 35: Shutting Down

    ANI Monitor V2 - Continuous analgesia monitoring system 7.11 Shutting down Selecting « Shutdown » switches off the ANI MONITOR V2. 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 36: 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...

  • Page 37: Operating Environment

    Before operating the system, wipe down all visible condensation and allow the system to reach equilibrium at room temperature. 10.2 Operating environment The ANI MONITOR V2 is not designed for use in areas containing flammable gases or vapors. WARNING: Explosion hazard: do not use the ANI monitor in an inflammable atmosphere or where concentrations of inflammable anaesthetics may accumulate.

  • Page 38: Maintenance

    62353 standard (for more details, refer to the technical manual available from Mdoloris). However leakage current must be checked systematically after every blood or liquid spill, or immediately after a major surge in the electrical system.

  • Page 39: Specifications, Warranty And Software License Contract

    ANI Monitor V2 - Continuous analgesia monitoring system replaced or substituted by personnel untrained in technical maintenance (following the manufacturer's instructions): End User Cable; Power cord; AC-DC Power supply; Pole clamp. 12 Specifications, warranty and software license contract 12.1 Specifications...

  • Page 40: Accessories

    ANI Monitor V2 - Continuous analgesia monitoring system 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: Warranty

    Products or parts replaced shall become Mdoloris Medical Systems’ property. In the course of warranty service, Mdoloris Medical Systems may but shall not be required to make engineering improvements to the Warranted Product or part thereof. If Mdoloris Medical...

  • Page 42: Software License Agreement

    12.4 Software License Agreement The computer software (“Licensed Software”) loaded on the ANI monitor (“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 43 ANI Monitor V2 - Continuous 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 44 SUPERSEDES ANY PROPOSAL OR PRIOR AGREEMENT, ORAL OR WRITTEN, AND ANY OTHER COMMUNICATIONS BETWEEN YOU AND 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...

Table of Contents