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TERMA BIOFEEDBACK User Manual

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BIOFEEDBACK
USER GUIDE
V.3.0.

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Summary of Contents for TERMA BIOFEEDBACK

  • Page 1 BIOFEEDBACK USER GUIDE V.3.0.
  • Page 2 BIOFEEDBACK system can be attached with the TERMA kinesiotherapy devices listed below. The devices, alike the BIOFEEDBACK are of the I class of medical devices, according to MDD Medical Device Directive 93/42/EEC for the medical devices for multiple usage:...

  • Page 3: Explanation Of Symbols

    2. EXPLANATION OF SYMBOLS It is mandatory to read the safety statements before using the device. The safety statements are classified as follows: Safety warnings and essential usage details. Safety of exploitation warnings. Unless followed, may result in minor personal injury and/or product/property damage.
  • Page 4 3. PRINCIPLES OF OPERATION AND STRUCTURE OF THE SYSTEM The general idea of BIOFEEDBACK system is based on reading the parameters, processing the signal, creating the graphic representation and passing the information back. BIOFEEDBACK’s aim is to help in achieving better therapeutic effects during the rehabilitation process and to increase motivation of the patient in performed exercises.
  • Page 5 Backside of the cover, which is plane, without the overprints, is the side that adjoins the device. On the front side of the cover, marked with the logo of TERMA, an arrow helps to place the sensor correctly, towards the front side of the device.
  • Page 6 Mini USB slot to attach the charger Arrow marking the direction of the sensor towards the front of the device CHARGING The sensor is charged by a 3.7V Lithium-ion battery. The battery is charged by a 5V charger, not less than 300mA, with micro USB slot.
  • Page 7 To start exploitation of BIOFEEDBACK system the sensor must be placed in the dedicated place on the device. ATTENTION! Installation of the sensor in the wrong place will disable the proper usage of the system! WAGA! Zamocowanie czujka w niewłaściwym kierunku uniemożliwi poprawne korzystanie z aplikacji.
  • Page 8 - if the distance between the sensor and mobile device during the connection does not exceed 10 m without direct borders like walls. The next stage for BIOFEEDBACK system is to turn the tablet with the application on and to run the application by choosing the icon shown below: Biofeedback The command asking to allow BIOFEEDBACK system to use the localization may appear.
  • Page 9 ”Start”. The welcome screen opens to provide the instructions to connect the devices.
  • Page 10 The next step asks for the four last characters of the MAC address found on the label of the device or in the user guide.
  • Page 11 As soon as the characters are chosen, they have to be confirmed by tapping „Next”. Searching for the device will begin. In case of choosing the wrong characters or another issue causing the interruption of connection appears, the application provides the information:...
  • Page 13 The suggested reasons must be checked and the process repeated by tapping “Back”. Successful connection will be confirmed with an information. After completing the steps above, the system is ready for exploitation.
  • Page 14 The user guide is attached to each device and is available to be downloaded from the Manufacturer’s website www.termamed.pl from the „Download” section. So start the exploitation, run the application by tapping on the tablet’s desktop: Biofeedback Application welcome screen opens.

  • Page 15: Device Selection

    DEVICE SELECTION As soon as the system is run, it’s time to select the device that the patient will exercise on. The device can be selected through the buttons on the right side or by sliding the devices icons in the central area of the screen.
  • Page 16 As soon as the device is selected, tap „Next”. JOINT AND EXERCISE SELECTION In the next step, after selecting the device, it’s time to choose the joint that will be rehabilitated (this option refers only to devices that provide rehabilitation in two joints independently). Then select the proper exercise in the right plane.
  • Page 17 The patient initiates the movement of the limb and the range of motion is reflected on the circle diagram located in the central area of the screen. To confirm the measurement, tap “Confirm calibration”.
  • Page 18 If the calibration was incorrect or the therapist is willing to motivate the patient to enlarge the range of motion, the measurement can be repeated by choosing „Repeat calibration”. This activity can me repeated unlimited number of trials until the optimum range of motion is set. To continue, tap „Next”.
  • Page 19 Patient’s personal information can be entered which helps to identify the report on the list of results after completing the session. Date and hour of completing the exercise will be added to the report automatically. EXERCISES The exercises are based on the completed calibration and parametrization. If the game mode was chosen, the proper graphic representation will be presented.
  • Page 20 In the game mode the progress is shown and % of completion. The red % refers to % of repeats realized vs. the total defined during parametrization. End of the task is signalized by thick line symbolizing a wall. If the patient needs during exercising to change the game mode into the chart mode, the switch is possible in the real time by tapping „chart mode”.
  • Page 21 In the chart mode the patient’s task is to lead the ball on the path marked with the reference black line. The path is defined by a ranges of motion measured during the calibration and chosen parameters during the parametrization. The pause button seen in the right upper corner of the screen pauses the game or chart.

  • Page 22: Browsing Results

    As soon as the report is closed, it’s available from the „Browsing results” section, dedicated only for therapists and secured with a four-characters unique PIN code provided with the BIOFEEDBACK system. The PIN code secures personal information of the patients. The “Browsing results” section is available after tapping the menu...
  • Page 23 Printing chosen results is available after copying the files from tablet to the PC. The files are PNG format files.

  • Page 24: Safety Instructions

    “Downloads” section. 8. CONTRAINDICATIONS AND RECOMMENDATIONS In order to ensure the highest comfort and safety during BIOFEEDBACK exploitation, it’s necessary to follow the contraindications and recommendations not only for BIOFEEDBACK but also for the device that is used to perform the therapy.

  • Page 25: Technical Details

    9. TECHNICAL DETAILS Manufacturer: Terma Sp. z o.o. Device: BIOFEEDBACK Version: V.3.0 Class: Class I Rule I...
  • Page 26 10. Warranty Terma Sp. z o.o. guarantees good condition and efficient operation of the device mentioned in the Warranty Card, hereinafter referred to as Product, according to the technical and exploitation details described in the user guide. Warranty confirms the responsibility of the entity who introduced the product to the market to free of charge removal of any faults of the product that was sold.
  • Page 27 a. Statements of unauthorized alerts or corrections in the Guarantee Card made by unauthorized entities. b. Statements made in the Product by unauthorized modifications or adjustments not expressly provided in the operating instructions. c. Statements of attempted repairs and interventions by third parties. d.
  • Page 28 11. INCIDENT APPLICATION FORM In the event of an incident that results in damage to the equipment or injury to the patient, manufacturer must be immediately reported. After filling the "Incident application form," given below, it should be provided termamed@termamed.pl to the manufacturer by e-mail or posted.
  • Page 29 Incident effects: ……………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………… .…………………………………………………………………………………………………………………………………………………… ….………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………………. Additional information: ……. ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………….…………………………………………………………………………………………………………………………… ………………………….………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ………………………….………………………………………………………………………………………………………………… …………………………………….……………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………….…………………………………………………………………… ………………………………………………………………………………….………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………………………………………………………………………………………………………………… ……………………………………….…………………………………………………………………………………………………… ………………………………………………….…………………………………………………………………………………………...