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MDMS ANI Monitor V2, User Manual

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MDMS ANI Monitor V2 User Manual Download Page 44

                           

ANI Monitor V2 - Continuous analgesia monitoring system

 

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

 

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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. If you transfer the System, you have 

the right to transfer the Licensed Software provided that the transferee agrees to be 

bound by the terms and conditions of this License Agreement. 

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. 

4. 

LIMITED  WARRANTY:  THE  LICENSED  SOFTWARE  IS  PROVIDED  “AS  IS” 

WITHOUT  WARRANTY  OF  ANY  KIND,  EITHER  EXPRESS  OR  IMPLIED, 

INCLUDING  WITHOUT  LIMITATION  ANY  WARRANTY  WITH  RESPECT  TO  ITS 

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  OPERATION  OF  THE  LICENSED  SOFTWARE  WILL  BE 

UNINTERRUPTED  OR  ERROR  FREE  OR  THAT  SUCH  ERRORS  IN  THE 

LICENSED SOFTWARE WILL BE CORRECTED. 

5.  LIMITATION  OF  REMEDIES  AND  DAMAGES:  MDOLORIS  MEDICAL  SYSTEMS' 

ENTIRE  LIABILITY  TO  YOU  FOR  ACTUAL  DAMAGES  FOR  ANY  CAUSE 

WHATSOEVER, AND REGARDLESS OF THE FORM OF THE ACTION, AND YOUR 

EXCLUSIVE  REMEDY  SHALL  BE  LIMITED  TO  THE  MONEY  PAID  FOR  THE 

SYSTEM, WHICH INCLUDED THE LICENSED SOFTWARE.  

IN  NO  EVENT  SHALL  MDOLORIS  MEDICAL  SYSTEMS  BE  LIABLE  TO  YOU  (a) 

FOR 

ANY 

INCIDENTAL, 

CONSEQUENTIAL, 

OR 

INDIRECT 

DAMAGES 

(INCLUDING  DAMAGES  FOR  LOSS  OF  BUSINESS  PROFITS,  BUSINESS 

INTERRUPTION,  LOSS  OF  BUSINESS  INFORMATION,  AND  THE  LIKE)  ARISING 

OUT OF THE USE OF OR INABILITY TO USE ANY LICENSED SOFTWARE EVEN 

IF MDOLORIS MEDICAL SYSTEMS OR ANY AUTHORIZED MDOLORIS MEDICAL 

SYSTEMS  REPRESENTATIVE  HAS  BEEN  ADVISED  OF  THE  POSSIBILITY  OF 

SUCH DAMAGES, OR (b) FOR ANY CLAIM BY ANY OTHER PARTY. 

6.  GENERAL:  this  License  Agreement  will  be  construed  under  French  laws.  If  any 

provision of this License Agreement shall be held by a court of competent jurisdiction 

to  be  contrary  to  law  that  provision  will  be  enforced  to  the  maximum  extent 

Summary of Contents for ANI Monitor V2

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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