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ANI Monitor V2 - Continuous analgesia monitoring system

MD/PRD/IN16.ANIV2 v.07 - 12 MAR 2020

P a g e

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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.

THIS LICENSE AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF

THE AGREEMENT BETWEEN YOU AND MDOLORIS MEDICAL SYSTEMS AND

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

[email protected]

and/or to the National Competent Authority

For any other problem:

please contact your Mdoloris Medical Systems representative or

[email protected]

Содержание ANI Monitor V2

Страница 1: ...2020 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 B timent C Epi de Soil 270 rue Salvad...

Страница 2: ...of the parasympathetic nervous system It may be used to monitor the effects of certain analgesic agents ANI Monitor V2 is intended for use as an adjunct to clinical judgment Clinical judgment should a...

Страница 3: ...g the ANI Monitor V2 and setting parameters 17 5 1 ECG Capture 17 5 2 Respiratory pattern 18 5 3 ANI index 19 5 4 ANI navigation 20 6 ANI Monitor V2 settings 20 6 1 Language parameters 20 6 2 Threshol...

Страница 4: ...d 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 softw...

Страница 5: ...nitor 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 ENVIRONMEN...

Страница 6: ...I 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 VICIN...

Страница 7: ...ENGINEERING TECHNICIAN PERIODICALLY PERFORMS MAINTENANCE WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR LIQUIDS OCCURS ON THE ANI Monitor V2 RE TEST GROUND LEAKAGE CURRENT BEFORE FURTHER USE OBSERVE U...

Страница 8: ...RONMENTS FOR WHICH CISPR 11 CLASS B IS REQUIRED ANI Monitor V2 CANNOT GUARANTEE PROVISION OF ADEQUATE PROTECTION OF RADIO FREQUENCY COMMUNICATION THE USER MIGHT NEED TO PERFORM CORRECTIVE ACTIONS SUCH...

Страница 9: ...EQUIPMENT ON TOP OF ANOTHER EQUIPMENT WITH A METAL CASING TO REMOVE POWER SUPPLY FROM THE MONITOR UNPLUG THE POWER CABLE DO NOT AUTOCLAVE THE MONITOR AUTOCLAVING WILL SERIOUSLY DAMAGE BOTH COMPONENTS...

Страница 10: ...F Type equipment protects against defibrillation European compliance Mark of compliance with the European Medical Device Directive Caution Federal law restricts this device to sale by or on the order...

Страница 11: ...a part of ANS activity it expresses the relative amount of p tone present as compared to sum of sympathetic and p activities ANI Monitor V2 displays two averaged ANI measurements ANIi results from the...

Страница 12: ...The electrodes are composed of a two part device a dual sensor and a single sensor connected together by an electrical thread The sensor itself is divided into two areas One part is an adhesive area...

Страница 13: ...of harm to the user or the patient Reusing a sensor could reduce adhesion leading to a possible decrease in ECG signal acquisition performance Reusing a sensor could reduce its adhesive strength due...

Страница 14: ...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...

Страница 15: ...tom centre of the screen NOTE 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...

Страница 16: ...MAR 2020 P a g e 16 45 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 consc...

Страница 17: ...he ANI index will not be reliable if the signal quality is not good enough red indicator If the user thinks the ECG amplitude is too low select Reset ECG to automatically recalibrate the ECG signal ac...

Страница 18: ...the middle of the screen to warn the user Select the button Auto gain in the bottom right corner of the screen to automatically recover the ECG signal If the signal quality is still medium or poor ch...

Страница 19: ...ne of the patient A calculation is made every second and then averaged over two time periods a short average average over two minutes and a longer average average over 4 minutes The monitor displays t...

Страница 20: ...r can scroll through the ANI measurements and see the events captured ANI navigation Select X to close this window Signal acquisition is not disturbed while the navigation window is opened 6 ANI Monit...

Страница 21: ...hreshold 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 f...

Страница 22: ...analgesia monitoring system MD PRD IN16 ANIV2 v 07 12 MAR 2020 P a g e 22 45 Input data If the user confirms without entering data he will be asked to insert a value between 0 and 100 Once data have b...

Страница 23: ...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...

Страница 24: ...ically memorized in the Index file type This can be downloaded on a USB stick see section 7 7 below It is also possible to edit your own list of events see section 7 8 below 6 4 Expert mode and energy...

Страница 25: ...Continuous analgesia monitoring system MD PRD IN16 ANIV2 v 07 12 MAR 2020 P a g e 25 45 Expert mode display of respiratory pattern and an additional function called Energy index Sudden drop of the ins...

Страница 26: ...ly influenced by other conditions than the patient s p tone In that case ANI calculation is interrupted even if the ECG is still being acquired The Energy index is a mathematical function applied on t...

Страница 27: ...will be asked to confirm this before you leave monitoring Do you really want to quit this recording Note if you respond Yes you will not be able to return to the current patient If you respond Yes th...

Страница 28: ...onfirmation Select OK to return to the main menu 7 6 Screen capture When the user selects Screen capture the information on the screen is saved in image format in the monitor s internal memory In orde...

Страница 29: ...ted incorrectly a message is displayed to indicate this Insert a USB key Once the USB is inserted correctly select OK to begin exporting the data Once the files have been exported successfully a confi...

Страница 30: ...ANI Monitor V2 Continuous analgesia monitoring system MD PRD IN16 ANIV2 v 07 12 MAR 2020 P a g e 30 45 Expert mode...

Страница 31: ...Energy Signal Energy ANI Instantaneous value of the ANI between 0 and 100 Expert Mode ANImean Averaged value of the ANI between 0 and 100 ANIc Instantaneous value of the ANI between 0 and 100 Classic...

Страница 32: ...s it will be considered by the program as a second complete recording It is then crucial to indicate this interruption in recording as an event so that this error is taken into account later when data...

Страница 33: ...hen 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 X Remove To validate any cha...

Страница 34: ...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 ke...

Страница 35: ...o 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 If the file ANI_V2...

Страница 36: ...ologically incorrect Check that electrodes are properly placed along an imaginary line through the heart acquisition of an electrical QRS axis See 3 3 The Mdoloris Medical Systems software does not st...

Страница 37: ...The monitor can be dismantled No metal parts are permanently attached inside the monitor housing All of the electrical parts meet the RoHS2 standard If you have to dispose of old electrical equipment...

Страница 38: ...onditions outside these limits could make it less reliable The monitor operates satisfactorily at sea level or above and is not affected by extremes or altitude changes up to 2000 m 10 3 Power require...

Страница 39: ...ck 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...

Страница 40: ...of the products are warranted during the life time of the products 5 years from the manufacturing date Annex IX Directive 93 42 EEC consolidated by 2007 47 EC Classification CISPR 11 Class A IIa Elec...

Страница 41: ...ous analgesia monitoring system MD PRD IN16 ANIV2 v 07 12 MAR 2020 P a g e 41 45 3 12 2 Accessories 2 Number Identification 1 ANI Monitor V2 2 Sensor 3 End User Cable 4 Power cord 5 AC DC Power supply...

Страница 42: ...ducts 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...

Страница 43: ...T TORT OR OTHERWISE SHALL NOT EXCEED THE ACTUAL PAYMENTS RECEIVED BY MDOLORIS MEDICAL SYSTEMS IN CONNECTION THEREWITH MDOLORIS MEDICAL SYSTEMS SHALL NOT BE LIABLE FOR ANY INCIDENTAL SPECIAL OR CONSEQU...

Страница 44: ...TS MERCHANTABILITY OR ITS FITNESS FOR ANY PARTICULAR PURPOSE MDOLORIS MEDICAL SYSTEMS DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE LICENSED SOFTWARE WILL MEET YOUR REQUIREMENTS OR THAT THE OPE...

Страница 45: ...NSE AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN YOU AND MDOLORIS MEDICAL SYSTEMS AND SUPERSEDES ANY PROPOSAL OR PRIOR AGREEMENT ORAL OR WRITTEN AND ANY OTHER COMMUNICATI...

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