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ANI Monitor V1 - Continuous analgesia monitoring system

MD/PRD/IN16.ANIV1 V.14 - 12 MAR 2020

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.

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.

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

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AUTHORIZED MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE HAS

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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

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Содержание ANI Monitor V1

Страница 1: ...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 B timent C Epi de Soil 270 rue Salvador Allen...

Страница 2: ...oring system may be used to monitor the effects of certain analgesic agents The Analgesia Nociception Index ANI is a complex monitoring technology intended for use as an adjunct to clinical judgment C...

Страница 3: ...ing 15 5 Using the ANI Monitor V1 and setting parameters 17 5 1 ECG Capture 17 5 2 Respiratory pattern 18 5 3 ANI index 19 5 4 ANI navigation 19 6 ANI Monitor V1 settings 20 6 1 Language parameters 20...

Страница 4: ...ent 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 38 11 2 Maintenance 39 12 Specificat...

Страница 5: ...the instructions in these warnings to prevent personal injury CAUTION A caution advises against actions or situations that could damage equipment produce inaccurate data or invalidate a procedure when...

Страница 6: ...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 Some...

Страница 7: ...NSIDERATION 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 SAFETY CER...

Страница 8: ...IO FREQUENCY COMMUNICATION THE USER MIGHT NEED TO PERFORM CORRECTIVE ACTIONS SUCH AS REIMPLANTATION OR REORIENTATION OF THE ANI Monitor V1 TO MINIMIZE THE RISK OF PATIENT STRANGULATION THE PATIENT INT...

Страница 9: ...MS 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 WI...

Страница 10: ...THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERATING NORMALLY PORTABLE RF COMMUNICATIONS EQUIPMENT INCLUDING PERIPHERALS SUCH AS ANTENNA CABLES AND EXTERNAL ANTENNAS SHOULD BE USED...

Страница 11: ...he patient Reusing a sensor could reduce adhesion leading to a possible decrease in ECG signal acquisition performance Reusing a sensor could reduce its adhesion The ANI Monitor V1 should not be used...

Страница 12: ...er use the ANI Monitor V1 only on battery power during surgery The monitor must be plugged on the main power supply especially while an electric knife is being used Only personnel trained by Mdoloris...

Страница 13: ...nd Storage Environment Keep dry Fragile handle with care BF Type equipment protects against defibrillation General safety sign Manufacturer Manufacturing Date Protective earth protective ground 2 ANI...

Страница 14: ...hesia respiratory rate lower than 9 cycles min electric noise during the measurement period 64 seconds irregular spontaneous ventilation patient speaking laughing or coughing pace maker certain types...

Страница 15: ...fic pole clamp which fit pole diameters ranging from 19 to 38 mm The user is responsible for ensuring that a suitable stand is used Figure 1 3 2 ANI Sensor V1 ANI Sensor V2 ANI Sensor V1 PLUS ANI calc...

Страница 16: ...In this case the dual sensor is applied on the patient s chest the big patch on the upper chest and the small patch on the left side of the chest see figure 4 WARNING Reusing a sensor already used on...

Страница 17: ...e pouch the electrodes shelf life is six months Biocompatibility has been tested on all Mdoloris Medical Systems sensors They meet standards ISO 10993 5 and ISO 10993 10 Before connecting carefully al...

Страница 18: ...The internal battery is not designed for long term monitoring The battery gauge has ten graduations each symbolizes around 10 min of battery life As soon as the power supply is interrupted a message a...

Страница 19: ...ever use the ANI Monitor V1 only on battery power during surgery The monitor must be plugged into the main power supply especially while an electric knife is being used 4 Beginning ANI Monitoring Turn...

Страница 20: ...ng 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 Figure 14 Once the monitor is co...

Страница 21: ...ctrodes are properly placed and connected to the cable WARNING always check in the upper left window that the signal quality is satisfactory green indicator The ANI index will not be reliable if the s...

Страница 22: ...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 tone Figure 17 R R normalized series with low amplitude respirator...

Страница 23: ...ed 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 5 4 ANI navigation Selecting ANI navigation under...

Страница 24: ...settings described in this section select Parameters on the bottom right of the screen during monitoring 6 1 Language parameters The user can choose the language Available languages are shown in the...

Страница 25: ...0 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 valu...

Страница 26: ...ANI Monitor V1 Continuous analgesia monitoring system 22 MD PRD IN16 ANIV1 V 14 12 MAR 2020 Figure 26 example with two threshold values captured Figure 26 Figure 27 Threshold values Figure 27 60 30...

Страница 27: ...ant ok breathing trble breathing induction awakening intubation extubation no stimulation surg stimulation hemo reaction movement cough reinject opioids reinject hypnotic VAS To insert one of these ev...

Страница 28: ...Monitor V1 Continuous analgesia monitoring system 24 MD PRD IN16 ANIV1 V 14 12 MAR 2020 Figure 29 Expert mode display of respiratory pattern and an additional function called Energy figure 30 Figure...

Страница 29: ...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 the R R series and does...

Страница 30: ...Select Quit patient at the top of the screen during monitoring to stop the session and return to the main menu You will be asked to confirm this before you leave monitoring figure 32 Figure 32 Note i...

Страница 31: ...atient monitoring session as well as a new set of exportable data files 7 4 Maintenance Selecting Maintenance figure 33 opens a window with an input field see figure 34 Access to this area is protecte...

Страница 32: ...image format in the monitor s internal memory Each time the user takes a snapshot one picture is saved in the monitor s memory A confirmation message is displayed when a snapshot has been successfully...

Страница 33: ...Figure 38 Once the files have been exported successfully a confirmation window appears figure 39 Select OK to return to the main menu Figure 39 Note Each data file is saved automatically in a file bea...

Страница 34: ...ent events appear on the ANI trend Select Quit patient at the top of the screen during monitoring to stop the session and return to the main menu A message asks you to confirm figure 32 Note if you re...

Страница 35: ...ing it and selecting X Remove To validate any change addition or deletion of one or more events confirm by selecting Apply before closing the window by selecting X 7 9 Setting date and time To set the...

Страница 36: ...ct 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 upda...

Страница 37: ...ANI Monitor V1 Continuous analgesia monitoring system 33 MD PRD IN16 ANIV1 V 14 12 MAR 2020 Figure 44 If the file AniM_INT exe is not present on the USB key a message will appear figure 45 Figure 45...

Страница 38: ...in at least once Check that there is a flat signal in the ECG window If no signal appears contact your Mdoloris representative An ECG signal is detected but seems to be incoherent flat irregular inter...

Страница 39: ...oesn t boot Check that the battery s power indicator is on figure 13 when the monitor is connected to a power supply If the power indicator is off remove the transparent cover and push the button The...

Страница 40: ...s fall under the RoHS2 directive If you have to dispose of old electrical equipment make sure it is recycled safely Collect it separately away from normal waste cans so that it can be reused processed...

Страница 41: ...g The monitor operates satisfactorily at sea level or above and is not affected by extremes or altitude changes up to 2000 m or atmospheric pressures ranging from 360 mmHg to 800 mmHg 10 3 Power requi...

Страница 42: ...After cleaning wipe the end of the connector with alcohol and allow it to dry completely Residual moisture inside the connector may affect the monitoring performance Cleaning the monitor screen Clean...

Страница 43: ...urant check according to the 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 sp...

Страница 44: ...products 5 years from the manufacturing date Material included with the ANI Monitor V1 Monitor Mdoloris Medical Systems Ref MN ANI V1 Manufactured by IEI product reference AFL 08A N270 Acquisition ca...

Страница 45: ...ed below can be lost or degraded ECG signal can be noisy This does not affect patient or equipment safety Classification CISPR 11 Class A IIa Electronic Medical Equipment 12 2 Warranty Mdoloris Medica...

Страница 46: ...loris Medical Systems in unsuitable packaging any physical damage present in the Product on receipt by Mdoloris Medical Systems and not previously reported will be presumed to have occurred in transit...

Страница 47: ...ou 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 tit...

Страница 48: ...TED 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...

Страница 49: ...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...

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