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Fesia Walk Instructions For Use Manual

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Instructions for Use
Fesia Walk

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Maxine Farr
June 12, 2025

The Fesia walk movement configuration is locked and asking for a password. However when we put the password the done button doesn't lit up to click it or we may not have the correct password

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Summary of Contents for Fesia Fesia Walk

  • Page 1 Instructions for Use Fesia Walk...
  • Page 3 Instructions for Use Guide Fesia Walk Rev.: 1.21 Date: 11/2018 English...
  • Page 4 MANUFACTURER: Fesia Technology SL Pº Mikeletegi 1 E-20009 Donostia SPAIN MAIL: support@fesiatechnology.com WEB: www.fesiatechnology.com SUPPORT: https://fesiatechnology.freshdesk.com/support/home COMERCIALIZED BY: Fesia Technology SL Pº Mikeletegi 1 E-20009 Donostia SPAIN 0051...

  • Page 5: Table Of Contents

    Warnings ................................1 Precautions ................................1 Adverse reactions ..............................2 2 Symbols and definitions ................ 3 3 Fesia Walk system description .............. 5 General description .............................. 5 System components ............................. 6 4 Fesia Walk operating instructions ............8 Verification ................................8 Placement ................................
  • Page 6 Guidance and manufacturer’s declaration– electromagnetic emissions ........... 30 8.5.2 Guidance and manufacturer’s declaration – electromagnetic immunity ..........31 8.5.3 Recommended separation distance between portable and mobile rf communications equipment and the Fesia Walk device ................................ 32 9 Contact information ................33...

  • Page 7: General Information

    1.1 Indications of use Fesia Walk is a rehabilitation device designed to provide dorsal and plantar ankle flexion for people suffering from foot drop/ equine as a result of central nervous system disease or injury. During gait, Fesia Walk electrically stimulates the motor nerves of the affected leg to achieve dorsal and plantar flexion of the foot, so that the user’s gait is improved.

  • Page 8: Adverse Reactions

    Instructions for Use: Fesia Walk • Caution when using the system if you have heart disease, epilepsy, or vascular or circulation problems is recommended. • Do not turn on the stimulator until it is properly placed on your leg. •...

  • Page 9: Symbols And Definitions

    Instructions for Use: Fesia Walk 2 SYMBOLS AND DEFINITIONS Symbol Meaning Caution Complies with European Medical Device Directive 0051 Manufacturer and date of manufacture Device reference number Serial Number  Device version aass  aa (year) ss (week) of fabrication FWxx-aassyy ...
  • Page 10 Instructions for Use: Fesia Walk Keep out of sunlight Keep dry This product should not be disposed with other household products Indicates low battery (red light) Indicates that the stimulation is active (yellow light) Indicates the intensity increase button Indicates the intensity reduction button Indicates the button on / off system Table 2-1: List of Symbols.

  • Page 11: Fesia Walk System Description

    3 FESIA WALK SYSTEM DESCRIPTION 3.1 General description The Fesia Walk device operation is based on surface electrical stimulation of the peroneal nerve and the posterior tibial nerve to cause plantar flexion and dorsiflexion in the corresponding gait phases. Figure 3-1: Device Fesia Walk.

  • Page 12: System Components

    Instructions for Use: Fesia Walk The Fesia Walk sensor is an inertial sensor that is placed in the foot and has two functions: the search of optimal stimulation parameters (configuration) and detection of the phases of gait. In the configuration phase the sensor is capable of measuring dorsiflexion, plantarflexion, eversion and inversion of the foot, and helps determining the optimum parameters and fields stimulation for each of these movements.
  • Page 13 Instructions for Use: Fesia Walk Which, in turn, contain the following elements: Figure 3-4: Elements of Fesia Walk. Number Element Stimulator Battery indicator LED Power and connectivity LED Stimulation LED Intensity increase button '+' On / off button Intensity decrease button '-'...

  • Page 14: Fesia Walk Operating Instructions

    Instructions for Use: Fesia Walk 4 FESIA WALK OPERATING INSTRUCTIONS 4.1 Verification It is important to check that the system is working properly before using it for the first time and it is also advisable to check it again after a long period of inactivity or if there are doubts about its correct operation.
  • Page 15 Instructions for Use: Fesia Walk Place the reference of central axis (12) of the garment two or three centimeters below the patella. Figure 4-2: Placement of the System with Central Reference. Close the garment using the magnetic fastener (11) and adjust it to suit.
  • Page 16 Instructions for Use: Fesia Walk Insert the stimulator into the base ot the electrode (8). Tighten until it clicks and make sure it is properly inserted. Figure 4-4: Stimulator Insertion. Place the sensor in the shoe by inserting the collet (16) of the sensor between the laces or velcro of the shoe.

  • Page 17: Turning On/Off

    Instructions for Use: Fesia Walk Once placed, the system should look approximately as shown in the following figure. Figure 4-6: Fesia Walk Placement. 4.3 Turning On/Off To switch the stimulator on and off, press and hold the On/Off button (6) for two seconds. When the stimulator has been switched on, the power LED (3) will start flashing.

  • Page 18: Luminous/Acoustic Indicators

    Table 4-2: Sensor Indicators. 4.5 Battery charge Use only the charger and charging cable supplied and / or approved by Fesia. Before the first use, the batteries must be fully charged. The charging process takes about 3 hours. Connect the charger to the network and the connector to the stimulator.

  • Page 19: Electrode Replacement

    Always check for redness or rashes on the skin when placed or removed Fesia Walk system. Be sure to replace the electrodes at least every 15 days and / or 10 sessions, even if they appear to be in good condition.

  • Page 20: Software Application

    5 SOFTWARE APPLICATION 5.1 General description The FES Manager Software Application connects wirelessly via Bluetooth to the Fesia Walk. This is a Chrome extension that can be run as tablet and PC application. These are the main functions of the FES Manager application: •...

  • Page 21: Pre-Configuration

    Instructions for Use: Fesia Walk Figure 5-2: Consent to Access Resources. After a waiting time, the application will appear along with all other extensions that the user has installed. Figure 5-3: Chrome Applications. To make the application accesible from the desktop or taskbar, right-click on the application and create shortcuts: Figure 5-4: Create Shortcut.

  • Page 22: Screenshots

    Instructions for Use: Fesia Walk Switch on the stimulator. The device will remain visible for 1 minute for all other Bluetooth devices, so that it can be paired up. Open the Bluetooth Wizard and perform a Bluetooth search for the stimulator on the computer. The identifier is made up as follows: "Fesia Walk"...

  • Page 23: User Accounts

    Instructions for Use: Fesia Walk Figure 5-7: Direct Access to FES Manager. When you start the application, the user account login screen will appear. Figure 5-8: Home Screen. 5.4.2 User accounts The application has user accounts to customize the operation of the application to each user and thus be able to independently manage the patients associated with it and the settings with the associated stimulator.
  • Page 24 Instructions for Use: Fesia Walk Figure 5-10: User Registration. To complete the registration, click on the Register button and a new doctor session will immediately begin. If you have a doctor account, enter your credentials directly and click "Start" on the initial screen.

  • Page 25: Configuration

    Instructions for Use: Fesia Walk 5.4.3 Configuration From the user account you can configure several parameters that will be associated with that session. To access this configuration, click on the tools icon at the top. Figure 5-12: Access to Configuration.

  • Page 26: Patient Management

    Instructions for Use: Fesia Walk If the connection of the application to the stimulator is lost, the application screen will be locked during the patient session and the connection must be restored through the Setup screen as indicated above. Figure 5-14: Session Lock Screen.

  • Page 27: Add / Modify Patient

    Instructions for Use: Fesia Walk Figure 5-16: Edit Patient. To start a new patient session, select the patient and click on the New Session button and you will immediately be taken to the Evaluation screen. 5.4.5 Add / Modify Patient The Add / Modify Patient screen allows you to edit patient data.

  • Page 28: Configuration

    5.4.7 Configuration The configuration is an important process to properly configure the Fesia Walk system before its implementation process. Performs a scan function on the cathodes and anodes available to stimulate the different possible configurations. The process allows to assess which is the optimal set of cathodes to use depending on the patient´s...

  • Page 29: Optimization

    Instructions for Use: Fesia Walk Figure 5-18: Configuration Screen. The doctor will be able to select the cathodes to be stimulated whth the associated anode configuration. Other configurations are also available such as the range of intensity amplitude for stimulation, as well as the pulse rate and frequency of stimulation.
  • Page 30 Instructions for Use: Fesia Walk As a result of the configuration, the set of cathodes and amplitudes that have best responded to this process is obtained. This information is displayed on the Optimization screen, where you can select the cathodes to be used while driving, and offer the possibility of adding new cathodes to the configuration.

  • Page 31: Gait

    Instructions for Use: Fesia Walk 5.4.9 Gait Once the configuration and optimization processes have been carried out, the gait screen allows the patient´s gait status to be monitored, as well as the amplitude data corresponding to dorsal and plantar flexion to be modified.

  • Page 32: Maintenance And Cleaning

    The Fesia Walk system it does not require maintenance, but caution in handling to avoid damage from unexpected knocks or falls. Do not attempt to repair the Fesia Walk or open the stimulator under any circumstances. In case of breakdown contact a Fesia technician.

  • Page 33: Troubleshooting

    Instructions for Use: Fesia Walk 7 TROUBLESHOOTING Fault description Troubleshooting Action The stimulator does not turn on The stimulator does not turn on unless it is connected to the Connect to the electrode and try again electrode The stimulator / sensor does not...

  • Page 34: Technical Information

    Instructions for Use: Fesia Walk 8 TECHNICAL INFORMATION 8.1 Stimulator specifications Parameter Description Classification Internal power, continuous operation with applied parts type BF Battery Type Rechargeable Lithium-Polymer 3,7V, 1400mAh Operating modes Gait, configuration and standby On / off button Controls...

  • Page 35: Sensor Specifications

    Instructions for Use: Fesia Walk 8.2 Sensor specifications Parameter Description Classification Internal power, continuous operation (without applied parts) Battery Type Rechargeable Lithium-Polymer 3.7V, 660mAh Operating modes Up, configuration and Hold Controls On / off button Two status LEDs • Indicators Communication (Blue) •...

  • Page 36: Charger Specifications

    2,04 8.5.1 Guidance and manufacturer’s declaration– electromagnetic emissions The Fesia Walk device intended for use in an electromagnetic environment specified below. The customer or user of the device should assure that it is used in such an environment Emissions test...

  • Page 37: Guidance And Manufacturer's Declaration - Electromagnetic Immunity

    RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the Fesia Walk device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocation the Fesia Walk device.

  • Page 38: Recommended Separation Distance Between Portable And Mobile Rf Communications Equipment And The Fesia Walk Device

    Recommended separation distance between portable and mobile rf communications equipment and the Fesia Walk device The Fesia Walk device is intended for use in a electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the Fesia Walk device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitter) and the Fesia Walk device as recommended below, according to the maximum output power of the communication equipment.

  • Page 39: Contact Information

    Instructions for Use: Fesia Walk 9 CONTACT INFORMATION If you need further assistance, please contact: Fesia Technology SL Pº Mikeletegi 1 E-20009 Donostia SPAIN Website: https://fesiatechnology.freshdesk.com/support/home e-mail: support@fesiatechnology.com...
  • Page 42 Fesia Technology SL Pº Mikeletegi 1 E-20009 Donostia SPAIN...

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