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Fesia Grasp Instructions For Use Manual

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Instructions for Use
Fesia Grasp

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  • Page 1 Instructions for Use Fesia Grasp...
  • Page 3 Instructions for Use Guide Fesia Grasp Rev.: 3.00 Date: 02/2020 English...
  • Page 4 MANUFACTURER: Fesia Technology S.L. Pº Mikeletegi, 1 20009 Donostia / San Sebastián Spain MAIL: support@fesiatechnology.com WEB: www.fesiatechnology.com SUPPORT: https://fesiatechnology.freshdesk.com/support/home COMERCIALIZED BY: Fesia Technology S.L. Pº Mikeletegi, 1 20009 Donostia / San Sebastián Spain 0051...

  • Page 5: Table Of Contents

    Warnings ................................1 Precautions ................................1 Adverse reactions ..............................2 2 Symbols and definitions ..............3 3 Fesia Grasp system description ............5 General description .............................. 5 System components ............................. 6 4 Fesia Grasp operating instructions ............. 7 Placement ................................7 Turning On/Off ..............................
  • Page 6 Guidance and manufacturer’s declaration– electromagnetic emissions ........... 29 8.1.2 Guidance and manufacturer’s declaration – electromagnetic immunity ..........30 8.1.3 Recommended separation distance between portable and mobile rf communications equipment and the Fesia Grasp device ............................... 31 9 Contact information ................. 32...

  • Page 7: General Information

    1.1 Indications of use Fesia Grasp is an electrical stimulation device designed to provide flexion and extension of the wrist and fingers in people with motor dysfunction of the hand after an injury or disease of the central nervous system. During grasping, Fesia Grasp electrically stimulates the appropriate muscles of the affected forearm to provide flexion and extension of the wrist and fingers to improve the grip of the individual.

  • Page 8: Adverse Reactions

    Instructions for Use: Fesia Grasp • This device should be kept out of reach of children. • 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 arm.

  • Page 9: Symbols And Definitions

    Instructions for Use: Fesia Grasp 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 Grasp 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 Grasp System Description

    Instructions for Use: Fesia Grasp 3 FESIA GRASP SYSTEM DESCRIPTION 3.1 General description The Fesia Grasp device operation is based on surface electrical stimulation of the forearm muscles to provide flexion and extension of the wrist and fingers. Figure 3-1: Device Fesia Grasp The main feature of this device is its multi-field electrode which allows better selectivity of movement and more natural movements.

  • Page 12: System Components

    Instructions for Use: Fesia Grasp Finally, Fesia Grasp has a software application that allows, on one hand, to control and configure the stimulation parameters and, on the other, to monitor the evolution of the different patients / users in an easy and intuitive way.

  • Page 13: Fesia Grasp Operating Instructions

    Instructions for Use: Fesia Grasp 4 FESIA GRASP OPERATING INSTRUCTIONS 4.1 Placement Clean and dry the skin before electrode placement for optimal adhesion. The skin must be cleaned of cream and oil residues before applying the electrode. If the area where the electrode is going to be placed has a lot of hair, it is advisable to shave the area for hygienic reasons and to ensure proper stimulation.

  • Page 14: Turning On/Off

    Instructions for Use: Fesia Grasp It is very important to leave the styloids uncovered by the textile band so that they are totally free when closed and the wrist has total freedom of movement. Then close the three parts of the textile band with the Velcro fastener.

  • Page 15: Luminous/Acoustic Indicators

    Table 4-1: Stimulator Indicators 4.4 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 16: Skin Care

    Always check for redness or rashes on the skin when placed or removed Fesia Grasp 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 17: Software Application

    5 SOFTWARE APPLICATION 5.1 General description The Fesia Pro application connects wirelessly via Bluetooth to the Fesia Grasp device. It is an Android application that can be run on any tablet that meets the minimum requirements specified in section Installation.

  • Page 18: Logging In

    Instructions for Use: Fesia Grasp Figure 5-2: Installed applications 5.4 Logging in The application has user accounts to customize the operation of the application to independently manage patients and associated devices. Therefore, the first time the application is run, you will be asked to log in. Once the user has logged in, they will no longer be required to log in until a logout action is performed.

  • Page 19: Bluetooth Connection To The Device

    Instructions for Use: Fesia Grasp You must fill in the requested fields. Those fields indicated with an * are the mandatory fields to be filled in. To finish this action, click on "Create account" and the Patient Management screen will automatically open.

  • Page 20: Selecting A Patient

    Instructions for Use: Fesia Grasp Figure 5-9: Fill in patient information 5.6.2 Selecting a patient Once created, the patient can be selected, modified or removed from the patient list. To start a session, select the patient by clicking on his/her name.

  • Page 21: Fesia Grasp Protocols

    "" button on the header. 5.7 Fesia Grasp protocols After selecting the Grasp function, the hand icon at the bottom of the page, the user can choose between 2 protocols: Training and Grasp. Figure 5-12: Fesia Grasp protocols 5.8 Training protocol...
  • Page 22 Instructions for Use: Fesia Grasp Figure 5-13: Configuration of the parameters of the Training Protocol To start the session, you need to set the training parameters: parameters: • Type of training: individual or couples scanning. All fields will be activated randomly, one by one or in pairs, alternating between flexors and extenders.

  • Page 23: Grasp Protocol

    5.9 Grasp protocol The Grasp protocol consists of two screens: configuration and grasp. 5.9.1 Configuration In this screen you can configure the 8 primitive movements that are used during the Grasp session: • Wrist flexion and extension • Thumb flexion and extension •...
  • Page 24 Instructions for Use: Fesia Grasp Figure 5-15: Configuration of primitive movements You must set the fields to be activated and the intensity of the stimulation for each of the primitive movements you want to use. The activated fields will appear in blue as in the following figure:...

  • Page 25: Grasp

    You can also execute 4 complex functions if their corresponding primitive movements have been previously configured. These functions are: palmar grasp, lateral grasp, pinch grasp and open hand.

  • Page 26: Sessions

    Instructions for Use: Fesia Grasp Figure 5-19: Grasp Once you have selected the movements and functions to be trained and the number of repetitions, you can start and stop the stimulation whenever you want. The following information will appear during the training: •...
  • Page 27 Instructions for Use: Fesia Grasp Figure 5-20: Saved sessions By clicking on the "Documents" button, symbolized by a paper page, the Session Report screen will open, where the videos can also be viewed if you have made recordings during that session.

  • Page 28: Settings

    Instructions for Use: Fesia Grasp 5.11 Settings Puede acceder a la configuración de la cuenta de usuario actual pulsando sobre el icono de los 3 puntos verticales en el encabezado. Figure 5-22: Settings On this screen you can: Select the language of the application.

  • Page 29: Daily Use

    To access a previous configuration, from "Sessions", click on the session to be repeated. Figure 5-25: Select session 3. Select protocol You can also start a session from the Grasp protocols, as explained in section 5.4. In either protocol the last used configuration will be shown.
  • Page 30 Instructions for Use: Fesia Grasp Figure 5-26:Select protocol 4. Start session selected Once the type of session to be carried out has been selected, the configuration of that session can be modified or the session can be started directly.

  • Page 31: Maintenance And Cleaning

    The Fesia Grasp 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 Grasp or open the stimulator under any circumstances. In case of breakdown contact a Fesia technician.

  • Page 32: Troubleshooting

    Instructions for Use: Fesia Grasp 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 unit beeps during...

  • Page 33: Technical Information

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

  • Page 34: Electrode Specifications

    Instructions for Use: Fesia Grasp Electrode specifications Parameter Description Models Right FesialGrasp v01 (right) and FesialGrasp Left v01 (left) Base: 100um PET Materials Fields electrode: silver ink bio-medical supports. Contacts: protected graphite 0.9mm thick (approx.) pH 4.2 (± 0.5%) Hydrogel...

  • Page 35: Guidance And Manufacturer's Declaration- Electromagnetic Emissions

    Instructions for Use: Fesia Grasp 8.1.1 Guidance and manufacturer’s declaration– electromagnetic emissions The Fesia Grasp 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 36: 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 Grasp 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 Grasp device.

  • Page 37: Fesia Grasp Device

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

  • Page 38: Contact Information

    Instructions for Use: Fesia Grasp 9 CONTACT INFORMATION If you need further assistance, please contact: Fesia Technology S.L. Pº Mikeletegi, 1 20009 Donostia / San Sebastián Spain Website: https://fesiatechnology.freshdesk.com/support/home e-mail: support@fesiatechnology.com...
  • Page 42 Fesia Technology S.L. Pº Mikeletegi, 1 20009 Donostia / San Sebastián Spain...

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