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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.

Mark of the active part of the device described on the illustrated scheme and explained in
table.

Содержание BIOFEEDBACK

Страница 1: ...BIOFEEDBACK USER GUIDE V 3 0 ...

Страница 2: ...ss of medical devices according to MDD Medical Device Directive 93 42 EEC for the medical devices for multiple usage AVIOR Ankle and knee joints rehabilitation device DRACO Ankle joint rehabilitation device PICTOR Wrist joints rehabilitation device AURIGA Balance platform Manufacturer Terma Sp z o o Czaple 100 80 298 Gdańsk Poland T 48 58 694 06 04 F 48 58 695 05 06 email termamed termamed pl www ...

Страница 3: ... 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 Mark of the active part of the device described on the illustrated scheme and explained in table ...

Страница 4: ...ncludes the sensor with the cover a stand a tablet The sensor is equipped with the battery SENSOR Accelerometer collects the data of the movements performed by a patient The sensor connects wireless with the application which uses the received data and the parameters set by a therapist to motivate the patient and to lead him her through the complete rehabilitation session The sensor is located und...

Страница 5: ...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 Wireless connection between the sensor and the application Bluetooth Application installed on the tablet that is mounted on the stand The sensor attached to the rehabilitation device The cover must be placed with the arrow towards the fro...

Страница 6: ...uous work time of the device after charging the battery 100 is around 540 h 4 Preparing the system for the exploitation If the battery liquid comes in contact with eyes or skin it s necessary to remove the liquid immediately with large amount of clean water and to contact the physician for the advice Mini USB slot to attach the charger Arrow marking the direction of the sensor towards the front of...

Страница 7: ...ings the application needs to be uninstalled on the tablet and installed again to repeat connecting the devices To connect the sensor and the application the four last numbers of MAC address are needed They can be found on the device s CE label and in the user guide UWAGA Zamocowanie czujka w niewłaściwym kierunku uniemożliwi poprawne korzystanie z aplikacji U WAGA Zamocowanie czujka w niewłaściwy...

Страница 8: ... active 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 Choose Allow The first s...

Страница 9: ... Start The welcome screen opens to provide the instructions to connect the devices ...

Страница 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 ...

Страница 11: ... 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 ...

Страница 12: ......

Страница 13: ... 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 ...

Страница 14: ...e user guide of the specific device 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 ...

Страница 15: ...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 ...

Страница 16: ...itated this option refers only to devices that provide rehabilitation in two joints independently Then select the proper exercise in the right plane CALIBRATION Next step is a calibration which is adaptation of the system to patient s ranges of motion To proceed the optimum ranges of motion for an individual patient must be defined Confirm the measurement by tapping ...

Страница 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 ...

Страница 18: ...pist defines the further therapeutic plan of exercises Number of repeats can be chosen together with position hold time and position reach time Game or chart mode can be chosen together with the game version presented as an icon on the right Therapist defines which limb is rehabilitated left right and if the exercising needs extra resistance The text field allows to enter any information that is e...

Страница 19: ...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 ...

Страница 20: ...ng 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 Returning to the game mode is also possible by tapping the game mode while the chart is running ...

Страница 21: ...ed 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 It can be started again any time ...

Страница 22: ... the screen The enlarged chart can be swiped in and out forward and backward for more careful analysis 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 se...

Страница 23: ...Printing chosen results is available after copying the files from tablet to the PC The files are PNG format files ...

Страница 24: ...s which do not allow for the implementation of the training 2 If the patient anthropometric conditions do not allow for adjustment of the structure of the device It is recommended to use sportswear made of cotton for full range of motion Before the BIOFEEDBACK exploitation it is necessary to read the user guide first and definitely follow the terms advices and warnings In case of any incidents whi...

Страница 25: ...9 TECHNICAL DETAILS Manufacturer Device Version Class Terma Sp z o o BIOFEEDBACK V 3 0 Class I Rule I ...

Страница 26: ...lude periodic maintenance and product reviews and in particular cleaning regulation performance control correction of operating errors or parameter programming and other actions that the user is responsible for The warranty excludes cases of random damage independent of operating conditions for example thefts accidents fires floods and mechanical damage caused by improper use 6 The Buyer by submit...

Страница 27: ...r work performed by the user in contravention of the user guide c Damages caused by the user s fault or ignorance d Product damages resulting from natural usage resulting from its use e Damage caused by the user s fault or ignorance f Damages caused by non original spare parts or use of materials not intended for use with the Product g Products whose Warranty Card or serial numbers have been alter...

Страница 28: ... filling the Incident application form given below it should be provided to the manufacturer by e mail termamed termamed pl or posted Name of institution Address Institution contact details Contact details of the patient involved in the incident Contact person name surname e mail and phone number Date of the incident Date of the notification Description of the incident ...

Страница 29: ...Incident effects Additional information ...

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