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ANI Monitor V1 - Continouous analgesia monitoring system

MD/PRD/IN16.ANIV1 V.10 – 29 SEP 2021

Sensors cable: Mdoloris Medical Systems reference: ANI-SC-V1

Manufacturer: Axon

Power cable: Mdoloris Medical Systems reference: ANI-PW-V1-x.

Degree of protection against electric shock of the system:

Class 1: equipment in which protection against electric shock does not rely on basic insulation

only, but which includes an additional safety precaution. Means are provided for the

connection of the equipment to the protective earth conductor in the fixed wiring of the

installation in such a way that accessible metal parts cannot become live in the event of a

failure of the basic insulation.

Protection against the ingress of liquids:

Be sure to install the ANI Monitor V1 (Screen and acquisition device) outside any area with a

risk of blood or liquids ingress.

System functioning:

Continuous: operation under normal load for a normal period without exceeding the specified

limits of temperature.

Classification:

- CISPR 11: Class A

- IIa Electro-Medical Equipment

12.2

Warranty

Mdoloris Medical Systems warrants to the initial Purchaser that the ANI Monitor V1 and the

acquisition device (“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. Excluded from this warranty are

expendable components and supply items such as, but not limited to, electrodes, cables, touch

screen and other accessories. Mdoloris Medical Systems’ obligations under this warranty are

to repair or replace any Warranted Product (or part thereof) that Mdoloris Medical Systems

reasonably determines to be covered by this warranty and to be defective in workmanship or

Содержание ANI 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: ...tients providing patient care by monitoring the parasympathetic nervous tones activity by data acquisition of ECG signals The continuous analgesia monitoring system and all its associated parameters m...

Страница 3: ...rn 22 5 3 ANI Index 23 5 4 Navigation panel 24 6 ANI monitor setup 25 6 1 Threshold 25 6 2 Events insert 28 6 3 Expert mode and Energy index 29 7 Operating the ANI monitor 32 7 1 Quit Patient 32 7 2 D...

Страница 4: ...ystem MD PRD IN16 ANIV1 V 10 29 SEP 2021 4 11 1 Care and Cleaning 44 11 2 Maintenance 45 11 3 Leakage Current 46 12 Specifications warranty and software license agreement 46 12 1 Specifications 46 12...

Страница 5: ...or situations that could damage equipment produce inaccurate data or invalidate a procedure although personal injury is unlikely A NOTE provides useful information regarding a function or procedure K...

Страница 6: ...ize the effect of interference Some ECT equipment may interfere with the proper functioning of the ANI Monitor V1 Check for compatibility of equipment during patient setup ONLY USE THE POWER CORD SUPP...

Страница 7: ...O PLACE THE INTERFACE EQUIPMENT DIRECTLY IN PROLONGED CONTACT WITH SKIN TO AVOID PERSONAL OR PATIENT INJURY DUE TO HIGH SURFACE TEMPERATURE THE CONDUCTIVE PARTS OF ELECTRODES OR SENSORS AND CONNECTORS...

Страница 8: ...ES BETWEEN DEFIBRILLATOR PADLLE WHEN IT S USED ON A PATIENT CONNECTED TO THE ANI Monitor V1 USE AGAIN AN ARRAY ALREADY USED ON PREVIOUS PATIENT COULD LEAD RISK OF CROSS CONTAMINATION IF THE PATIENT DE...

Страница 9: ...D LEAKAGE CURRENT BEFORE FURTHER USE UNIVERSAL PRECAUTIONS SHALL BE OBSERVED TO PREVENT CONTACT WITH BLOOD OR OTHER POTENTIALLY INFECTIOUS MATERIALS CONTAMINATED MATERIALS MUST BE PLACED IN A FACILY I...

Страница 10: ...carefully before using the monitor in a clinical setting Before starting please ensure there are no USB devices USB stick for example connected to the monitor Equipment should not be reachable by the...

Страница 11: ...ust perform service or repairs on ANI Monitor V1 The ANI Monitor V1 contains an internal battery This battery must be removed by an authorized technician and discarded or recycled in accordance with n...

Страница 12: ...t 1 3 Notes The Notes can be found at the end of each related chapter 1 4 Key to Symbols Symbol Description Symbol Description Operator s manual operating instructions Serial number Caution Federal la...

Страница 13: ...stimuli from bronchial stretch sensors Each respiratory cycle spontaneous or in positive pressure gives an information about the instantaneous p tone by measuring the amplitude of the associated sharp...

Страница 14: ...in order to predict hemodynamic reactivity during general anesthesia GA When surgical stimulation was constant all hemodynamic reactivity episodes 20 increase of heart rate or systolic arterial press...

Страница 15: ...ned to retrieve information related to QRS complex The acquisition of a cardiac vector is enough to get an ANI calculation The electrodes are composed of a device in two parts a dual sensor and a sing...

Страница 16: ...f the abdomen see next page the example with figure 4 WARNINGS Use again an array already used on previous patient could lead risk of cross contamination If the patient develops a cutaneous rash or ot...

Страница 17: ...tches on the connection support for a perfect match pins figures 5 and 7 To disconnect the electrodes grasp the plastic support by pressing on the locking mechanism and pull it normally to disengage i...

Страница 18: ...r to plug the monitor into an electrical main supply quickly The ANI index is still calculated during this event NOTE To ignite the monitor it has to be plugged in first intention to prevent a sudden...

Страница 19: ...e bottom right hand corner of the front side figure 12 NOTE if the front switch doesn t reboot the monitor check the green rear button is really bright If this power indicator is still dim lift up the...

Страница 20: ...ata can be interpreted before this initialization time lapse The screen will then indicate Calibration figure 14 Once the monitor is connected to the patient with the electrodes and the initialization...

Страница 21: ...acquisition device to recover the ECG signal If the display is not coherent check the correctness of the electrodes position and also the quality of the connection between electrodes and the amplifier...

Страница 22: ...step we have developed an innovating algorithm based on the Fast Wavelets Transform allowing us to precisely identify the R spics from the QRS signal 5 2 Respiratory Pattern The surface of influence o...

Страница 23: ...areas under the curve Therefore we display continuously an index each measurement based on the respiratory patterns window of 64 seconds with 1 second moving window that reflects the parasympathetic...

Страница 24: ...waves are not correctly detected or too many ectopic beats are corrected ANI measurements are suspended until ECG detection is correct or normal sinus rhythm is back 5 4 Navigation panel Pressing the...

Страница 25: ...displayed when the navigation window has been opened 6 ANI Monitor V1 setup Pressing the button Parametreler in the bottom right hand corner of the screen during the monitoring gives the possibility t...

Страница 26: ...21 26 If you click on the X button without capturing the threshold values a new window will appear figure 25 click on TAMAM Click on the first input field and capture a first threshold value figure 26...

Страница 27: ...ANI Monitor V1 Continouous analgesia monitoring system MD PRD IN16 ANIV1 V 10 29 SEP 2021 27 Figure 27 example with the two captured threshold values Figure 26 Figure 27...

Страница 28: ...ues 6 2 Events insert As shown in the screen below figure 29 here you have the possibility to insert clinic events so that they can be visible into the tendencies curves and also in the exportable dat...

Страница 29: ...ents cough re inject morphinic re inject hypnotic VAS The insertion of one of these events among the list leads automatically the memorization in the kind file Index It is possible to download this fi...

Страница 30: ...ANI Monitor V1 Continouous analgesia monitoring system MD PRD IN16 ANIV1 V 10 29 SEP 2021 30 Expert mode which displays respiratory pattern and one more function called Energy figure 31 Figure 30...

Страница 31: ...etic tone It means something abnormal in regard to the organism non physiological situation The Energy index could drop under 0 05 when a pacemaker leads the heart rate when ephedrine or atropine for...

Страница 32: ...ng the button Durdur in the top of the screen will end the monitoring and give access to main menu A confirmation window will appear before definitively stop the monitoring figure 33 To note by clicki...

Страница 33: ...functioning 7 3 New patient Selecting Yeni hasta figure 34 initializes the monitoring and launches a new patient data including new file storage 7 4 Maintenance Selecting Bak m figure 34 opens a windo...

Страница 34: ...Pressing the button Temizle deletes all data previously computed and saved A first window will ask for confirmation of this action figure 36 When all data are deleted another window will appear to co...

Страница 35: ...USB port called Data Export Then the user selects Durdur in the top of the screen In the new window opened figure 34 choose Veri k Alma The pictures will be saved in a file Each file name will follow...

Страница 36: ...use A file named Export will automatically be created on the USB device Each file name will follow this rule Hour Minute Month Day Year Example It is also possible to do a permanent download by connec...

Страница 37: ...on window will appear see figure 33 chapter 8 1 To access and update the events list press Uygulama G ncelleme The events update menu will appear figure 41 To add new event in the list you have to use...

Страница 38: ...Saat Ayarlar The following window will appear Use the arrows to choose the modifications you want To valid the changes done you have to confirm by touching Uygula then X to close the window 7 10 Upda...

Страница 39: ...D PRD IN16 ANIV1 V 10 29 SEP 2021 39 A message will appear to confirm the success of the updating figure 44 After 5 seconds press on ANI Monit r e geri d n If an USB stick isn t plugged a message will...

Страница 40: ...ANI Monitor V1 Continouous analgesia monitoring system MD PRD IN16 ANIV1 V 10 29 SEP 2021 40 If the AniM_INT exe isn t present on the USB stick a message appears figure 46 Figure 45 Figure 46...

Страница 41: ...from the acquisition device to the monitor Try to unplug and plug again the acquisition device from the monitor An ECG signal is detected but seems to be incoherent flat irregular interfered Check th...

Страница 42: ...ted the monitor before you dispose of your system You should respect local regulations regarding electric and electronic items There are no metallic items inside the acquisition device s box The acqui...

Страница 43: ...ween heated buildings and outside storage Once moved inside allow the monitor to stabilize in the unopened shipping container at the inside ambient temperature before unpacking and placing into servic...

Страница 44: ...IT IS REPLACED WITH A THREE SLOT GROUNDED OUTLET BEFORE ATTEMPTING TO OPERATE THE MONITOR THE MONITOR SHOULD BE USE ONLY WITH A HARMONIZED POWER CABLE WITH A SURFACE SECTION SUPERIOR TO 0 75 mm 11Car...

Страница 45: ...completely WARNING WHENEVER AN EVENT SUCH AS SPILLAGE OF BLOOD OR SOLUTIONS OCCURS RE TEST LEAKAGE CURRENT BEFORE FURTHER USE DO NOT MIX DISINFECTING SOLUTIONS AS HAZARDOUS GASES MAY RESULT CAUTION do...

Страница 46: ...12 1 Specifications Power Requirements 100 240 Volts 50 60 Hz 3A Consummation 32 W Electrical Safety category 1 conforms to IEC 60601 1 Battery Li ion output 12 V 5 3800mAH Around 90 minutes of full u...

Страница 47: ...device outside any area with a risk of blood or liquids ingress System functioning Continuous operation under normal load for a normal period without exceeding the specified limits of temperature Clas...

Страница 48: ...or damage during shipments under this warranty shall be borne by the party shipping the Product Products shipped by Purchaser under this warranty shall be packaged in the original shipping container...

Страница 49: ...HOUT LIMITATION LOST PROFITS DIRECTLY OR INDIRECTLY ARISING FROM THE SALE INABILITY TO SELL USE OR LOSS OF USE OF ANY PRODUCT EXCEPT AS SET FORTH HEREIN ALL PRODUCTS ARE SUPPLIED AS IS WITHOUT WARRANT...

Страница 50: ...RESS 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 CON...

Страница 51: ...y 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 A...

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