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Fesia WALK Instructions For Use Manual

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INSTRUCTIONS
FOR USE
FESIA WALK

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  • Page 1 INSTRUCTIONS FOR USE FESIA WALK...
  • Page 2 MANUFACTURER Fesia Technology S.L. Pº Mikeletegi, 58 20009 Donostia / San Sebastián (Gipuzkoa) Spain COMERCIALIZED BY Fesia Technology S.L. Pº Mikeletegi, 58 20009 Donostia / San Sebastián (Gipuzkoa) Spain E-MAIL: support@fesia.net WEB: www.fesiatechnology.com 0051 Rev.: 6.0 These Instructions for Use can be visualized through any PDF viewer installed on your Date: 2022/10 computer.
  • Page 3 GENERAL INFORMATION..FESIA WALK DEVICE FESIA PRO APPLICATION MYWALK APPLICATION TECHNICAL SUPPORT MAINTENANCE TECHNICAL INFORMATION 8-11 ..14-23 ..26-47 ..50-57 ..60-61 .....64-67 ..70-77 Indications of use General description General description General description Troubleshooting Electrodes maintenance Stimulator specifications Legend Indicators Installation and registration...

  • Page 4: General Information

    GENERAL INFORMATION...

  • Page 5: Indications Of Use

    Fesia Walk stimulates the motor nerves of the affected leg by means of specifically for this purpose.
  • Page 6 This product should not be disposed with other household products Low battery (red light) Stimulation is active (yellow light) Intensity increase button Intensity reduction button On/off button INSTRUCTIONS FOR USE | Fesia Walk 11 10 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 7 FESIA WALK DEVICE...

  • Page 8: General Description

    FESIA WALK DEVICE GENERAL DESCRIPTION The Fesia Walk device operation is based on superficial electrical stimulation to cause plantar flexion and dorsiflexion in the corresponding gait phases. The main feature of this device is its multi-field electrode which allows better selection of movement and shorter setup time. ...
  • Page 9 Reduce intensity bu�on S�mula�on off Bluetooth indicator S�mulator on Start of the Gait protocol without tablet Beep. Pulse sound S�mulator off INSTRUCTIONS FOR USE | Fesia Walk 17 16 INSTRUCTIONS FOR USE | Fesia Walk Ba�ery indicator Low ba�ery level...

  • Page 10: Initial Checks

    The skin should be clean and dry to assure op- Make sure you have wifi connection in order to Create an account in the Fesia Pro app and make charged. This process takes about 3 hours. Con- timal placement of electrode. The skin must create an account.

  • Page 11: Device Placement

    CONNECT TO THE APP Once all the components are properly placed and switched on, open the Fesia Pro or MyWalk app and choose a Bluetooth device to connect. Before starting, read the information on the app de- scribed in Chapter 3 and 4.
  • Page 12 For more information on electrode mainte- There are separate collection systems for nance, see "Electrode maintenance". recycling in the EU. INSTRUCTIONS FOR USE | Fesia Walk 23 22 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 13 FESIA PRO APPLICATION...

  • Page 14: Installation And Registration

    GENERAL DESCRIPTION INSTALLATION AND REGISTRATION It is not required to read this section if you have received a pre-configured tablet by Fesia. The device on which the application is installed must meet It is important to ensure not to use the application more...
  • Page 15 Select the language of the application. Change Bluetooth device. Export/Import data from another tablet. Save configuration in the stimulator to use the Fesia Walk without tablet and import the sessions performed. Report an issue to Fesia Support Check the device information.
  • Page 16 Sessions Walk To access the protocols, select the “Walk” icon in the navigation menu. The patient’s data will be shown in the “Detail” menu. The mandatory fields are indicated with an asterisk. There, the user can select between the following 6 protocols:...
  • Page 17 Clicking on the "Movements configuration" button it is possible to access time while testing motor response. the movements configuration screens. INSTRUCTIONS FOR USE | Fesia Walk 33 32 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 18 Intensity/motor treshold Clicking on the "Set Motor Threshold" button, the intensity value will be saved so that you can use it later in the configuration screen. INSTRUCTIONS FOR USE | Fesia Walk 35 34 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 19 - An undefined duration clicking on the "Loop" button (the counter will start groups. from 0). Area stimulation: The pads selected by the us- ers are activated. 36 INSTRUCTIONS FOR USE | Fesia Walk INSTRUCTIONS FOR USE | Fesia Walk 37...
  • Page 20 It loads the current configuration values. It will always change to this in the virtual electrode. state when you modify any parameter of the loaded configuration. INSTRUCTIONS FOR USE | Fesia Walk 39 38 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 21 Remember to check that the configuration has been carried out correctly by restarting the device and verifying that, af- ter activating the gait mode without tablet, the yellow light flashes when the sensor is moved. 40 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 22 Movements Configuration screens. Up to 3 periods with different levels of assistance can be con- figured by modifying the 3 time and intensity fields. INSTRUCTIONS FOR USE | Fesia Walk 43 42 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 23 "Exit without saving". If the intensity is modified, remember that it is in- creasing relative to the intensity value configured in the Movements Configuration screens. INSTRUCTIONS FOR USE | Fesia Walk 45 44 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 24 If the intensity is modified, remember that it is in- The feedback windows can be hidden from the patient creasing relative to the intensity value configured in to increase the challenge. the Movements Configuration screens. INSTRUCTIONS FOR USE | Fesia Walk 47 46 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 25 MYWALK APPLICATION...
  • Page 26 "ST16-XXXXXX". Select the device you want to pair and press “Connect”. When the connection is es- tablished, the indicator of battery of the stimulator and sensor will appear at the header. INSTRUCTIONS FOR USE | Fesia Walk 51 50 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 27 The user can: Select the app language. Check the device information: basic information about the de- vice connected to the app and the version of the application. INSTRUCTIONS FOR USE | Fesia Walk 53 52 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 28 Activated anode This parameter is related to the comfort and safety. Then, it is highly recommended to increase it gradually taking the motor threshold into account. INSTRUCTIONS FOR USE | Fesia Walk 55 54 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 29 The session can be Start gait gait” to proceed to the next started/stopped at any time. screen. INSTRUCTIONS FOR USE | Fesia Walk 57 56 INSTRUCTIONS FOR USE | Fesia Walk...

  • Page 30: Technical Support

    TECHNICAL SUPPORT...

  • Page 31: Troubleshooting

    Make sure you have checked the following steps before contacting Fesia: Once you have taken the previous steps, if your problem is not already solved, you can Check that your Fesia Pro app or MyWalk app are updated (Google Play Store, "Menu", "Apps and games"). contact Fesia with the 'Support' button at the Settings screen preferably.

  • Page 32: Maintenance

    MAINTENANCE...

  • Page 33: Electrode Maintenance

    To disinfect it, immerse in a 1% hydrogen peroxide solution for 5 minutes. If possible, use a UV device to disinfect the surface. Make sure to place it on both sides. Regarding the drying time, check with the supplier of the UV equipment. 64 INSTRUCTIONS FOR USE | Fesia Walk INSTRUCTIONS FOR USE | Fesia Walk 65...

  • Page 34: Skin Care

    Instead use a beard trimmer or scissors. If you are in any doubt, stop using your FES device and wait to speak to your FES clinician. 66 INSTRUCTIONS FOR USE | Fesia Walk INSTRUCTIONS FOR USE | Fesia Walk 67...

  • Page 35: Technical Information

    TECHNICAL INFORMATION...

  • Page 36: Sensor Specifications

    Measured at 45 strides per minute. Dorsal and Plantar Flexion or only Dorsal Flexion, 4 cathodes, 40mA. Dorsal and Plantar Flexion or only Dorsal Flexion, 2 cathodes, 20mA. INSTRUCTIONS FOR USE | Fesia Walk 71 70 INSTRUCTIONS FOR USE | Fesia Walk...

  • Page 37: Charger Specifications

    Optimum temperature for long-term storage: 5ºC to 27ºC Recommended storage time: 3 months (sealed) Class II Protection Expiration time: 3 years (sealed) Relative humidity: 35% to 50% Atmospheric pressure: 700hPa to 1060hPa INSTRUCTIONS FOR USE | Fesia Walk 73 72 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 38 Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey should be less than the compliance level in each frequency range. Interference may occur in the vicinity of the equipment marked with the following symbol: INSTRUCTIONS FOR USE | Fesia Walk 75 74 INSTRUCTIONS FOR USE | Fesia Walk...
  • Page 39 Between 80 MHz and 800 MHz, the separation distance is applied in the highest frequency range. • These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, object and people. INSTRUCTIONS FOR USE | Fesia Walk 77 76 INSTRUCTIONS FOR USE | Fesia Walk...

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