Mdoloris PTA Monitor User Manual
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Mdoloris PTA Monitor User Manual

Continuous analgesia monitoring system
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Continuous analgesia monitoring system
User manual
PTA
monitor
TM
Software version: V2.3.0.0
Société Mdoloris Medical Systems SAS
270, rue Salvador Allende
Biocentre Fleming, Bâtiment C
Parc Eurasanté - Epi-de-Soil
59120 LOOS
Tél : 03 62 09 20 80 - Fax : 09 72 38 75 27
www.mdoloris.com
MD/PRD/IN16.PTA v.06 - 12 MAR 2020

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  • Page 1 Continuous analgesia monitoring system User manual monitor Software version: V2.3.0.0 Société Mdoloris Medical Systems SAS 270, rue Salvador Allende Biocentre Fleming, Bâtiment C Parc Eurasanté - Epi-de-Soil 59120 LOOS Tél : 03 62 09 20 80 - Fax : 09 72 38 75 27 www.mdoloris.com...
  • Page 2 Mdoloris Medical Systems is a commercial registered trademark. Important information about the use of PTA monitor: The Mdoloris Medical Systems’ PTA monitor is intended for use in a medical environment and under the direct supervision of a licensed healthcare practitioner or by personnel specifically trained for its use.

  • Page 3: Table Of Contents

    Warnings ........................4 Caution ........................8 Notes ........................8 Key to symbols ......................9 2 PTA monitor introduction ..................... 10 PTA index ......................11 Position of sensors and ECG acquisition ..............11 Monitor setting ....................... 12 Demo mode ......................12 3 Start the PTA monitoring ....................

  • Page 4: Safety Precautions

    NOTE A note provides useful information regarding a function or procedure. DEFINITION OF SYMBOLS Symbols used with the PTA monitor are explained at the end of this section (section 1.4, page 09). Warnings IT IS FORBIDDEN TO KEEP CONNECTED THE PTA MONITOR ON ANIMAL WHEN A DEFIBRILLATOR DEVICE IS USED.
  • Page 5 PTA monitor User manual EXPLOSION HAZARD: DO NOT USE THE PTA MONITOR IN A FLAMMABLE ATMOSPHERE WHERE CONCENTRATIONS FLAMMABLE ANESTHETICS MAY OCCUR. THIS MONITOR IS NOT DESIGNED FOR USE IN THE MRI ENVIRONMENT. ONLY USE THE POWER CORD SUPPLIED BY THE MANUFACTURER. NEVER ADAPT THE PLUG FROM THE MONITOR TO FIT A NON-STANDARD OUTLET.
  • Page 6 PTA monitor User manual ON ELECTRICAL SHOCK HAZARD : DO NOT ATTEMPT TO DISCONNECT THE POWER CORD WITH WET HANDS. DO NOT REMOVE MONITOR COVERS DURING OPERATION OR WHILE POWER IS CONNECTED TO MONITOR. THE MANUFACTURER OF THIS DEVICE HAS VERIFIED THAT THE...
  • Page 7 IN CASE OF PERSISTENT DYSFUNCTION, PLEASE CONTACT YOUR MDOLORIS MEDICAL SYSTEMS REPRESENTATIVE. THE PTA MONITOR IN OPERATING SURGICAL ROOM MUST BE PLACED OUTSIDE THE SAFETY CONE OF EXPLOSION RISK. BE SURE THAT THE MONITOR IS PLACED OUT OF AN AREA PRESENTING A RISK OF PROJECTION OF LIQUID (E.G.: UNDER AN I.V.

  • Page 8: Caution

    The PTA Monitor should not be used adjacent or stacked on other equipment. If adjacent or stacked use is necessary, check regularly that the functioning is normal in this configuration.

  • Page 9: Key To Symbols

    PTA monitor User manual Key to symbols Symbol Description Symbol Description Consult the operating Manufacturer’s serial number manual European conformity. Mark of Do not expose to liquids conformity to European medical device directive Do not expose to sunlight General hazard symbol...

  • Page 10: Pta Monitor Introduction

    PTA monitor User manual PTA monitor introduction PTA (Parasympathetic Tone Activity) is a normalized and continuous measure of the parasympathetic tone (p) which is a part of the autonomous system (ANS). It uses the punctual and quick increase of pƩ tone induced by each respiratory cycle (spontaneous or artificial) to measure the “relative quantity”...

  • Page 11: Pta Index

    PTA monitor User manual PTA index We have developed an innovating algorithm based on the amplitude assessment of respiratory patterns of the RR series. An index is continuously displayed, reflecting the parasympathetic tone activity: the average PTA (in orange, indicated “mean” on the right of the screen). A strong nociceptive stimulation leads an almost instantaneous decrease of the amplitudes of the RR series’...

  • Page 12: Monitor Setting

    PTA monitor User manual Monitor setting Position the monitor in order to use easily the power plug. The power cable has to be screwed on the appropriate socket on the lower side of the monitor. The acquisition box has to be plugged on the RS232/422/485 port (figure 2).

  • Page 13: Start The Pta Monitoring

    PTA monitor User manual 3 Start the PTA monitoring When the power cable is plugged on socket of power supply, a power light indicator above the screen will become orange. The monitor can be ignited by pressing during 3 seconds the interrupter located on the low side of the monitor (figure 4).
  • Page 14 (indicator with orange color on the top of the screen), there is no possible interpretation (PTA index and heart rate non viewable). Once the PTA monitor is connected to the patient via the clips and the ECG signal is good, the calculation algorithm will start automatically.

  • Page 15: Use And Settings

    PTA monitor User manual 4 Use and settings The selection of “Parameters” localized on the right of the screen during the monitoring will allow to reach different settings introduced in the following chapters. Languages The user can choose the language display. Select the touch “Parameters”. Then choose the desired language dropdown list and select the language desired to activate it (figure 7).
  • Page 16 PTA monitor User manual Figure 8 If you select the button “X” without any values, a window will appear (figure 9): select “OK”. Figure 9 Select the first blank square and put the low values that you want (figure 10). Then select “Valid”.
  • Page 17 PTA monitor User manual Then the parameters window displays the values chosen (figure 11). Select “Valid” for activating and displaying the thresholds on the monitoring display. Figure 11 The threshold area will be displayed on the monitoring in progress (figure 12): Figure 12 MD/PRD/IN16.PTA v.06 - 12 MAR 2020...

  • Page 18: Events

    PTA monitor User manual Events As showed on the figure 7, the user can insert some events in order to get the corresponding plot on the curve. The events inserted will also be present in the data that the user could export.
  • Page 19 The Energy index doesn’t mean at any moment a concept of patient’s energy or patient’s parasympathetic tone but an ECG signal norm acquired by the PTA Monitor. MD/PRD/IN16.PTA v.06 - 12 MAR 2020...

  • Page 20: Snapshot

    PTA monitor User manual To set up the “Expert” mode, once entered in parameters setup (button “Parameters”), touch the button “Expert” then the button “Valid” to return to the main screen. To cancel the “Expert” mode and return to the “Classic” mode, do the same procedure but touch the button “Classic”...

  • Page 21: End Of The Pta Monitoring

    The selection of “New patient” will start a new monitoring with new data (figure 3). Maintenance Selecting “Maintenance” (figure 19) opens a window with an input field (see figure 25 next page). This access is protected by a code that will be forwarded on request to Mdoloris Medical Systems. Figure 19...

  • Page 22: Export The Data Recorded

    PTA monitor User manual Export the data recorded The selection of the button “Export” (figure 3) will send all data saved from the monitor memory into a USB key. The USB key should have been plugged before on the lower side of the monitor.

  • Page 23: Date And Time Settings

    PTA monitor User manual Figure 20 To add new events in the list, you have to use the virtual keyboard on the screen and then √ valid with the button “ Valid”. Word size is limited to 18 characters. The new event will be added at the end of the drop-down list displayed on the right. To see it, you have to use the scrollbar.

  • Page 24: Update Monitor

    “Apply” and then press “X” to close the window. Update monitor In the main menu (figure 3), select “Update monitor”. Plug an USB stick with the new version of the PTA software provided by your Mdoloris Medical Systems representative. Then select “Update monitor” (figure 3). Shut down In the main menu (figure 3), select “...

  • Page 25: Troubleshooting

    Systems interlocutor. 7 Monitor disposal WARNING: To avoid any kind of contamination or infection on persons, on environment or on equipment, be sure you have properly disinfected and decontaminated the PTA monitor MD/PRD/IN16.PTA v.06 - 12 MAR 2020...

  • Page 26: Environnement

    8 Environnement Shipping and Storage Environnement The PTA monitor and its accessories can be stored or shipped within the following environmental limits. Note that these limits apply to non-operational storage and shipping situations: Shipping and storage temperature: - 20 to + 60 °C...

  • Page 27: Operating Environnement

    1066 hPa. Power Requirements and System Grounding The PTA Monitor requires a power source of 100 to 240 VAC, 50-60Hz. To protect operating personnel and patients, the monitor must be properly grounded. The power cord grounds the system to the power line ground when plugged into an appropriate three-wire socket.

  • Page 28: Leakage Current

    Wipe the connector ends with alcohol and allow it to dry completely. Leakage Current The PTA monitor is designed so that it does not need any adjusting or calibration. However, the leakage current should be checked systematically after saline or blood projection or after a major high voltage surge in the internal house electrical system or at least once a year.

  • Page 29: Specifications, Warranty And Software License Agreement

    PTA monitor User manual 10 Specifications, warranty and software license agreement 10.1 Specifications Power requirements: Input: voltage: 100-240 Vac Frequency: 50 – 60 Hz Current: 1.5 A Output: voltage: + 12 VDC Current: 3.0 A Electrical Safety: Class 1 conforms to IEC 60601-1 Weight of the monitor with collet fixture: 1.9 Kg.

  • Page 30: Warranty

    10.2 Warranty Mdoloris Medical Systems warrants to the initial Purchaser that the PTA monitor (“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.
  • Page 31 Mdoloris Medical Systems ; or that have been disassembled, serviced, or reassembled by anyone other than Mdoloris Medical Systems, unless authorized by Mdoloris Medical Systems.

  • Page 32: Software Licence Agreement

    The computer software (“Licensed Software”) loaded on the PTA 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 33 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...

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