Instructions for Use
Fesia Walk
Instructions for Use
Guide
Fesia Walk
Rev.: 1.21
Date: 11/2018
English
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
INDEX
1 General information .............................................................................. 1
1.1 Indications of use ................................................................................................................................................. 1
1.2 Contraindications ................................................................................................................................................. 1
1.3 Warnings ............................................................................................................................................................... 1
1.4 Precautions ........................................................................................................................................................... 1
1.5 Adverse reactions ................................................................................................................................................. 2
2 Symbols and definitions ........................................................................ 3
3 Fesia Walk system description .............................................................. 5
3.1 General description .............................................................................................................................................. 5
3.2 System components ............................................................................................................................................. 6
4 Fesia Walk operating instructions ......................................................... 8
4.1 Verification ........................................................................................................................................................... 8
4.2 Placement ............................................................................................................................................................. 8
4.3 Turning On/Off ................................................................................................................................................... 11
4.4 Luminous/acoustic indicators ............................................................................................................................ 12
4.4.1 Stimulator ....................................................................................................................................................... 12
4.4.2 Sensor ............................................................................................................................................................. 12
4.5 Battery charge .................................................................................................................................................... 12
4.6 Electrode replacement ...................................................................................................................................... 13
4.7 Skin care .............................................................................................................................................................. 13
5 Software application ........................................................................... 14
5.1 General description ............................................................................................................................................ 14
5.2 Installation .......................................................................................................................................................... 14
5.3 Pre-configuration ............................................................................................................................................... 15
5.4 Screenshots ........................................................................................................................................................ 16
5.4.1 Starting the application ................................................................................................................................. 16
5.4.2 User accounts ................................................................................................................................................ 17
5.4.3 Configuration ................................................................................................................................................. 19
5.4.4 Patient management ..................................................................................................................................... 20
5.4.5 Add / Modify Patient ..................................................................................................................................... 21
5.4.6 Evaluation ....................................................................................................................................................... 21
5.4.7 Configuration ................................................................................................................................................. 22
5.4.8 Optimization .................................................................................................................................................. 23
5.4.9 Gait ................................................................................................................................................................. 25
6 Maintenance and cleaning .................................................................. 26
6.1 Transport ............................................................................................................................................................ 26
6.2 Disposal of equipment and accessories ............................................................................................................ 26
7 Troubleshooting .................................................................................. 27
8 Technical information ......................................................................... 28
8.1 Stimulator specifications.................................................................................................................................... 28
8.2 Sensor specifications .......................................................................................................................................... 29
8.3 Electrode specifications ..................................................................................................................................... 29
8.4 Charger specifications ........................................................................................................................................ 30
8.5 EMI Tables .......................................................................................................................................................... 30
8.5.1 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
Instructions for Use: Fesia Walk
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1 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.
Functional electrical stimulation may also enhance motor relearning, muscle strength, prevent or slow down muscle
atrophy, increase local blood flow and / or maintain / increase the range of motion.
1.2 Contraindications
• People with cardiac pacemakers or other electrical or metallic implants, unless recommended
by a physician.
• People with severe epilepsy or a recent history of frequent seizures.
• Tumors or cancerous lesions in the area where electrical stimulation is applied.
1.3 Warnings
• Do not use this device to control machines, drive or perform any activity where an involuntary
movement could pose a risk of injury.
• Do not place the electrode on the head, eyes, mouth, throat (carotid sinus), chest or back.
Place the electrode on the leg only as indicated in the manual.
• Simultaneous use of Fesia Walk and other high frequency medical devices could cause skin
burns in the electrode area and could damage the stimulator.
• Using the system less than one meter away from shortwave or microwave therapy equipment
may cause instability in the output of the stimulator.
• Electrode placement near the thorax may increase the risk of atrial fibrillation.
• Do not attempt to repair the Fesia Walk or open the stimulator under any circumstances. In
case of breakdown contact Fesia technician.
• Prolonged use of the electrode increases the risk of skin irritation.
• Use of worn electrodes could cause skin burns or loss of function of the system.
• Improper use or use of a defective system may cause skin burns, muscle damage or falls.
1.4 Precautions
• This device must be used under the supervision of a physician or clinician, physiotherapist or
care giver and may only be operated by personnel trained specifically for this purpose.
• The system should not be used if there is presence of lesions and/or wounds of any kind (skin,
muscle, tendon, bone...) in the area and at the time of applying electrical stimulation.
• Do not use this device if you experience any symptoms of malfunction or if any of the
components are in poor condition.
• Should not be exposed to liquids and splashes.
• Should not be exposed to extreme temperatures.
• Should not be exposed to direct sunlight.
• Should not be used near flammable products.
• Store the system under protection from moisture, dust and direct sunlight.
• Only use electrodes supplied by Fesia.
• Use only the charger and charging cable supplied and / or approved by Fesia.
• This device should be kept out of reach of children.
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• 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.
• The electrode is personal, it should not be exchanged between different people.
• Make sure both the stimulator and the sensor are charged before each use.
• The long-term effects of chronic electrical stimulation are unknown.
• The safety of using electrical stimulation during pregnancy has not been determined.
1.5 Adverse reactions
• Electrical stimulation could cause an uncomfortable feeling or very mild pain in the first usess
until the feeling becomes familiar.
• It is normal for the area where stimulation has been applied to appear red after removing the
device, this redness should disappear in about an hour.
• Electrical stimulation or gel contact with the skin may cause irritation or allergic reaction on
the contact surface in some cases.
• The patient should immediately stop using the system in the following cases:
• Redness or irritation at the site of application of stimulation for more than one hour
after removing the electrode.
• Blisters or sores in the area of application of stimulation.
• Feel a significant increase in muscle spasticity.
• Tachycardias heart feels stress or during stimulation
• It has swelling of the leg, knee, ankle or foot.
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2 SYMBOLS AND DEFINITIONS
Symbol
Meaning
Caution
0051
Complies with European Medical Device Directive
Manufacturer and date of manufacture
Device reference number
Serial Number
FWxx-aassyy
xx Device version
aass aa (year) ss (week) of fabrication
Yy Correlative number of the same batch
Consult the instructions
Double insulation (equivalent to Class II according to IEC 536)
Type BF applied parts
Continuous load current
Non-Ionizing Radiation
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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.
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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.
The main feature of this device is its multi-field electrode which allows better selectivity of movement and shorter setup
times since it can automate the search for an optimal configuration. The device consists of a stimulator, a multi-field
electrode, a sensor, a textile garment and a software application.
The stimulator generates electrical pulses, which are transmitted to the skin through the multi-field electrode. It is a
matrix electrode designed to cover both the posterior and lateral areas of the knee and thus be able to stimulate the
peroneal and posterior tibial nerves. It consists of 16 cathodes (output fields) and four anodes (return fields) that can
be activated independently or in combination, thus allowing adaptation to the different patient physiology. The multifield electrode is personal and disposable, with an estimated life of two weeks of daily use. The textile garment ensures
proper electrode- skin contact and, on the other hand, serves as a support for both the stimulator and electrode.
Figure 3-2: Electrode Fesia Walk and Textile Garment.
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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. During gait, the sensor is able to detect the
takeoff and foot contact times in order to trigger the stimulation with the corresponding parameters.
Finally, Fesia Walk has a software application that can run on different operating systems and platforms (PC, tablet,
mobile) 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. The application is specifically designed for
use by healthcare personnel. Chapter 5 details the characteristics of the system.
3.2 System components
Check the case and ensure that the Fesia Walk kit contains all of the following components:
1. Stimulator
2. Sensor
3. Charger and splitter 2x1
4. Textile garment
5. 2-electrodes (1 Left, 1 Right)
6. Pre-configured Tablet (optional)
Figure 3-3: Components of the Fesia Walk System.
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Which, in turn, contain the following elements:
Figure 3-4: Elements of Fesia Walk.
Number
Element
1
Stimulator
2
Battery indicator LED
3
Power and connectivity LED
4
Stimulation LED
5
Intensity increase button '+'
6
On / off button
7
Intensity decrease button '-'
8
Electrode base
9
Electrode
10
Textile Garment
11
Locking system
12
Reference of central axis
13
Power LED (sensor)
14
Battery indicator LED (sensor)
15
On / off LED (sensor)
16
Collet (sensor)
Table 3-1: Fesia Walk Elements Description.
15
13
14
16 1 2
3 4 5 7 6
8
9
10
11
11
12
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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.
To do this, perform steps 5 and 6 of placement, avoiding placing the electrode on the leg; turn on the stimulator and
sensor, and use the system normally, checking that the light and acoustic signals are working properly. Then turn off the
stimulator and sensor and perform the placement steps again from the beginning, placing the electrode on your leg.
Start by applying low stimulation parameters (amplitudes <5 mA) and gradually increase them to ensure correct
operation.
4.2 Placement
1. 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.
2. Carefully remove the electrode gel protective layer. Keep this protective layer as you will need it to store
it at the end of its use. This layer protects the gel from dirt and dust.
Figure 4-1: Separation of the Protective Layer from the Electrode.
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3. 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.
4. Close the garment using the magnetic fastener (11) and adjust it to suit.
Figure 4-3: Closing and Adjustment of the Textile Garment.
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5. 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.
6. Place the sensor in the shoe by inserting the collet (16) of the sensor between the laces or velcro of the
shoe.
Figure 4-5: Sensor Placement.
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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. It will remain flashing until it is paired with the sensor.
To turn the sensor on and off, press and hold the on / off button (15) for a few seconds. When the sensor has been
turned on, the power LED (13) will start flashing. It will remain flashing until it is paired with the stimulator.
When both devices are turned on, they will try to pair automatically, switching from a blue flashing light to a permanent
lighting when paired.
Once all system components are properly placed and turned on, use the software application described in the next
chapter to configure the system and use it while walking. Make sure not to use the software application more than 5
meters away from the stimulator.
Use the increase (5) and decrease (7) controls marked with '+' and '-' symbols respectively to adjust the stimulation
intensity level during walking. These changes will act simultaneously for both plantar and dorsal configurations.
To switch off the stimulator press and hold the on / off button (6) for a few seconds. When the stimulator is turned off,
all LEDs will turn off. Also, to turn off the sensor, press and hold the on / off button (15) for a few seconds. When the
sensor is turned off, all LEDs will turn off.
Finally, carefully remove the garment and place the protective layer back on the electrode gel. If the electrode gel is
dry, pour a few drops of water over it before placing the protective layers on it.
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4.4 Luminous/acoustic indicators
4.4.1 Stimulator
Indicator
State
Meaning
Red light
Off
Suitable battery level (between 100-40%)
Slow blinking (5 sec.)
Low battery level (40-20%)
Fast blinking (1sec.)
Very low battery level (20-0%)
Continuous
Battery charging
Blue light
Off
Stimulator off
Blinking
The stimulator is waiting for connection
Continuous
The stimulator is connected to the sensor or PC
Orange light
Off
No active stimulation
Continuous
Active stimulation
Sound
Single tone short beep
Increase / decrease button pushed
Two-tone beep
Failed stimulation attempt (no current is emitted)
Table 4-1: Stimulator Indicators.
4.4.2 Sensor
Indicator
State
Meaning
Blue light
Off
Sensor off
Blinking
The sensor is waiting for connection
Continuous
The sensor is connected to the stimulator
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. Make sure that the plug is fully inserted. The red stimulator LED
will light while charging and will turn off when charging is complete.
One of the accessories provided is a USB cable splitter, with which using a single charger, you can charge the two
elements (stimulator and sensor).
The battery may only be replaced by authorized personnel.
Make sure both the stimulator and the sensor are fully charged before each use.
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Figure 4-7: Fesia Walk Loading.
4.6 Electrode replacement
The electrode is a disposable item that should be replaced at least every 15 days of daily use or every 10-15 sessions.
However, it must be replaced if any defect or anomaly is observed. The multi-field electrodes are attached to a socket,
which is necessary for correct connection to the stimulator and to facilitate electrode replacement.
Whenever the electrode needs to be changed, remove the old electrode carefully with its socket and insert the new
electrode by matching the socket in the cavity of the garment for this purpose.
4.7 Skin care
Lack of proper skin care and improper or prolonged use of electrical stimulation may result in skin irritation or an adverse
skin reaction. Skin irritation may occur after approximately three months of use. Therefore, it is important to follow a
daily skin care routine in order to use the system for a long time without damaging the skin.
- Clean the skin where the electrodes are attached with a damp cloth before each use. If there is presence
of oils or lotions on the skin, then wipe it off with soap and water.
- 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.
- Excessive body hair in the area where the electrodes are attached may reduce skin contact. If necessary,
remove excess body hair in the place where electrodes are attached with scissors or wax. Do not use a
razor blades, as they may irritate the skin.
- When placing the garment, make sure that the electrodes make contact with the skin evenly.
- Remove the garment and electrode for at least 15 minutes every three to four hours in order to let the
skin breathe.
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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:
• Fesia Walk configuration.
• Management of patients associated with the doctor.
• System status monitoring (battery level, connectivity, operating mode, etc).
It is important to ensure not to use the application more than 5 meters away from the stimulator to not lose the
connection.
5.2 Installation
The device on which the application is installed must meet the following requirements:
• Operating system Windows 7/8/10, Chrome OS or Apple OS and OSX computers
• Chrome browser version 35 or above
• V.2.0 Bluetooth connection or higher
• Minimum screen size 10 "
The application is called FES Manager and is available in the App Store Google Chrome Web Store. By searching for the
application using the text "FES Manager" can accessed the information portal directly:
Figure 5-1: Application Portal.
To install the application, simply click on the "Add to Chrome" option at the top. The installation process will start
automatically once consent to give the application permission to access system resources has been accepted:
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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.
5.3 Pre-configuration
Once the application is installed, it is necessary to pair the stimulator with the computer in order to be able to carry out
Bluetooth communication between the application and the device. Here are the steps to register the stimulator on a
Windows 7 computer:
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1. Switch on the stimulator. The device will remain visible for 1 minute for all other Bluetooth devices, so that it
can be paired up.
2. Open the Bluetooth Wizard and perform a Bluetooth search for the stimulator on the computer. The identifier
is made up as follows:
"Fesia Walk" + SN
Figure 5-5: Device Search.
3. Pairing the device without using any code.
Figure 5-6: Pairing Device.
5.4 Screenshots
Below are the complete operating instructions within the application.
5.4.1 Starting the application
Once the stimulator has been paired with the mobile device, the stimulator can be configured via application. To start
the application, click the shortcut from the desktop, taskbar or application list in Chrome.
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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.
To create a new user account, click the available text next to the Start button
Figure 5-9: Create New Account.
You will then need to fill out the form in order to login successfully:
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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.
Figure 5-11: Login.
You will be taken directly to the Patient Management screen. If this is the first time that the application is accessed with
that account, it will ask you to select a directory to save the data related to the user´s interaction with the application.
Figure 5-11: Directory Selection.
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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.
From Settings the doctor can perform the following operations:
Figure 5-13: Setup Screen.
1. Device selection. If more than one stimulator is available, the system to be used can be selected. All devices
paired with your computer will appear in the list. From this same control, the stimulator can be switched off.
Figure 5-15: Device List.
2. Language selection. The user can choose between Spanish and English as the languages of the application.
3. Maximum amplitude. From the configuration screen, the maximum amplitude value that the stimulator can
exert is displayed
4. System information. Basic information of the system connected to the application and version of the
application.
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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.
5.4.4 Patient management
The doctor has a Patient Management screen to manage the end users of the system associated with your account.
Actions such as creating, editing or deleting patients are available, as well as initiating a new user session. This screen
will always be available from the top Patients icon.
Figure 5-15: Patient Management.
As an initial presentation, previously added patients appear in a table where they can be selected for editing, deleting
or logging in.
The Add / Edit Patient screen allows you to add or edit the selected patient.
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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.
Figure 5-17: Patient Edition.
The information recorded contains data related to the patient´s identification, data related to their pathology and the
medical center to which it belongs.
5.4.6 Evaluation
The evaluation screen makes it easy to evaluate the patient's progress in terms of foot movement. It measures the angle
reached by the foot in the Dorsal and Plantar movements. Passive movement (with the help of the doctor) and active
movement (without the doctor's help) are distinguished. To start the evaluation, press the Neutral Position button, so
that the application evaluates the rest of the positions according to the initial position.
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Figure 5-20: Neutral Position Evaluation.
Once the initial process has been completed, the rest of the positions can be evaluated and the maximum degree of the
angle acquired can be indicated graphically.
Figure 5-21: Plantar Assessment and Active.
The data will be stored to be displayed in the report section, where the patient's progress will be indicated in the
different evaluations carried out.
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
movement during the scan.
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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.
It is advisable to modify the amplitude with caution!
This parameter is related to the comfort and safety of the application of the electrical stimulation, so
it is advisable to increase it gradually, always respecting the user´s comfort threshold.
The available controls are described below:
• Start / Restart: Starts the configuration process or restarts it from the beginning.
• Skip Step: Removes the active cathode and discards it for further optimization.
• Stop / Resume Pause the stimulation process during configuration or restores it.
Figure 5-23: Configuration Control.
5.4.8 Optimization
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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.
Figure 5-19: Optimization Screen.
The Optimization screen is divided into 2 parts:
• Dorsal Flexion: This is the set of cathodes that best responded during configuration for dorsal movement. It is
divided into the primary movements Left, Up and Right.
• Plantar Flexion: This is the set of cathodes that best responded during configuration for plantar movement. It
is divided into the primary movements Left, Down and Right.
Once the cathodes have been selected and the amplitude and anode data corresponding to the blending have been
modified, the configuration is sent to the stimulator to be used during the gait.
It is advisable to modify the amplitude with caution!
This parameter is related to the comfort and safety of the application of the electrical stimulation, so
it is advisable to increase it gradually, always respecting the user´s comfort threshold.
Figure 5-20: Sending the Flexion Configuration.
The gait configuration will not be completed until both flexion movements are sent.
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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.
Figure 5-21: Gait Screen.
The corresponding controls are shown below:
• Start / Pause: Starts the gait or stops it.
• Amplitude in Dorsal and Plantar Flexion: Increases or decreases the value of the amplitude intensity in a unit,
in the corresponding bending movement. The values are in the range of 1 and a maximum current amplitude
value corresponding to the setting.
The gait screen allows real-time monitoring of the patient´s movement. Shows the bending performed and the cathodes
and anodes activated in the stimulation.
Figure 5-22: Active Gait.
As additional information, the Gait screen indicates the session time since it was started and the steps taken by the
patient during that session.
It is advisable to modify the amplitude with caution!
This parameter is related to the comfort and safety of the application of the electrical stimulation, so
it is advisable to increase it gradually, always respecting the user´s comfort threshold.
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6 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.
Although it is recommended to change the electrode at least after 15 days of daily use or when any defect or anomaly
is noticed, the electrode may sometimes appear dry or lose its adhesion properties during this time. In that case, once
the protective plastic has been removed, pour about 10 drops of water on it and spread this water over the entire gel
with your fingers. Wait 3-4 minutes until the gel has absorbed the water.
The electrode is personal, it must not be exchanged between different people.
Figure 6-1: Electrode Maintenance.
You can clean the stimulator and sensor housings using a clean, soft cloth.
You can wash the textile garment with soap and water after removing the electrode from the band.
Store the Fesia Walk properly after each use to prolong its life.
• Turn off the stimulator and the sensor.
• Replace the protective plastics on the electrode gel.
• Store the system in a place protected from moisture, dust and direct sunlight.
6.1 Transport
Transport equipment should always be in the case provided for this purpose and provided RESPECTING environmental
conditions described in Section 8 Technical information.
6.2 Disposal of equipment and accessories
At the end of the useful life of this product, follow local regulations for disposal or recycling of Fesia Walk equipment
and accessories.
This symbol means that the product contains an integrated rechargeable battery that complies with
the European Directive 2013/56 / EU, and cannot be disposed of with normal household waste. We
strongly recommend that you take the product to an official collection point or to Fesia Technology
for a professional removal of the rechargeable battery. Find out more about the local selective
collection system for rechargeable batteries and electrical and electronic products. Follow local
regulations and never dispose of the product or batteries with normal household waste. Proper
disposAL of used products and batteries helps to avoid negative consequences for the environment
and human health.
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7 TROUBLESHOOTING
Fault description
Troubleshooting
Action
The stimulator does not turn on
The stimulator does not turn on
unless it is connected to the
electrode
Connect to the electrode and try again
The stimulator / sensor does not
turn on
There is a problem with the
battery or microprocessor
Load equipment
The stimulator unit beeps during
configuration or during the gait
There is a connection problem
between the electrode and
stimulator
Check electrode alignment at the base
Check electrode integrity
Replace the electrode and / or base
The stimulator gives indications of
stimulation but no stimulation is
felt
The equipment may have
suffered an internal failure
Restart your computer and check again
The software stops responding or
does not connect to the stimulator
/ sensor
There is a communication failure
or an application failure
Restart the application and the tablet
No movement found
The electrode is not properly
positioned or the parameters are
not correct
Make sure the electrode / textile are well placed and
tightened
Adjust the stimulation parameters manually to user´s
tolerance
Slightly change the position of the textile garment
and repeat the process from the beginning
Instructions for Use: Fesia Walk
28
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
Controls
On / off button
Intensity increase button (+)
Intensity decrease button (-)
Indicators
Three status LEDs
• Communication (Blue)
• Battery / Alarms (Red)
• Active stimulation (Yellow)
Audio (buzzer)
Dimensions
26 mm x 76 mm x 52 mm
Weight
91 gr.
Load characteristics
5V - 0.5A
Environmental conditions
Operating temperature: 5ºC to 40ºC
Charging temperature: 5 ° C to 40 ° C
Transport and storage temperature: -20 to 60 ° C
Relative humidity: 15% to 90%
Atmospheric pressure: 1060hPa 700hPa to
Wireless communication
Two Bluetooth modules: Bluetooth 3.0 and Bluetooth 4.0 - Dual mode
Maximum load
5000Ω
Maximum output power
1.5W
Protection
IP22
Generated pulse parameters
Pulse type
Symmetrical biphasic or compensated biphasic
Pulse intensity
0 - 60mA, 1mA resolution (for loads <5000Ω)
Pulse width
150us -. 300 us, resolution of 10us
Pulse frequency
1 - 40Hz resolution of 1 Hz
Maximum output voltage
180V
Maximum output frequency
1KHz
Instructions for Use: Fesia Walk
29
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
Indicators
Two status LEDs
• Communication (Blue)
• Battery / Alarms (Red)
Dimensions
43 mm x 46 mm x 16 mm
Weight
22 gr.
Load characteristics
5V - 0.5A
Environmental conditions
Operating temperature: 5ºC to 40ºC
Charging temperature: 5 ° C to 40 ° C
Transport and storage temperature: -20 to 60 ° C
Relative humidity: 15% to 90%
Atmospheric pressure: 1060hPa 700hPa to
Protection
IP22
Wireless communication
Bluetooth 3.0
8.3 Electrode specifications
Parameter
Description
Models
Right FesialWalk v01 (right) and FesialWalk Left v01 (left)
Materials
Base: 100um PET
Fields electrode: silver ink bio-medical supports.
Contacts: protected graphite
Hydrogel
0.9mm thick (approx.)
pH 4.2 (± 0.5%)
Approved tests: Cytotoxicidad, Primary Skin Irritation, Delayed
Hypersensitivity
External dimensions
270mm x 140mm
Cathodes
16 distributed in two rows and 8 columns
Area: 270mm2 (18mm x 15mm)
Anodes
4 distributed in one row and four columns
Area: 600mm2 (30mm x 20mm).
Environmental conditions
Operating temperature: 5ºC to 40ºC
Transport and storage temperature: 0 to 40
Optimum temperature for long-term storage: 5°C to 27°C
Recommended storage time: 3 months (sealed)
Maximum storage time: 1 year (sealed)
Relative humidity: 35% to 50%
Atmospheric pressure: 1060hPa 700hPa to
Instructions for Use: Fesia Walk
30
8.4 Charger specifications
Parameter
Description
Maker
FRIWO
Model
F0X6-XM
Connector
IP42 approved interchangeable plug system as additional accessories
B connector
Micro-USB
Output Voltage
5 VDC
Supply voltage
100-240 VAC 50-60Hz
Current
1400mA
Others
IEC 60601-1 approved
Protection
Class II
8.5 EMI Tables
System Characteristics
Module 1
Module 2
Module 3
Function
Stimulator Main
Stimulator- Sensor
Sensor-Stimulator
Module
Lairdtech BT900
ST SPBT3.0DP2
ST SPBT3.0DP2
Frequency (MHz)
2402-2480
2402-2480
2402-2480
Max. declared output power (dBm)
8
2,6
2,6
Max. antenna gain (dBi)
+0,5
+0,5
+0,5
Max. E.I.R.P (dBm)
8,5
3,1
3,1
Max. E.I.R.P (mW)
7,08
2,04
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
Compliance
Electromagnetic environment guidance
RF emmisions
CISPR 11
Group 1
The Fesia Walk device uses RF energy only for its internal
function. Therefore, its RF emissions are very low and are
not likely to cause any interference in nearby electronic
equipment.
RF emmisions
CISPR 11
Class B
The Fesia Walk device is suitable for use in establishments
other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
Flickers emissions
IEC 61000-3-3
Fulfill
Instructions for Use: Fesia Walk
31
8.5.2 Guidance and manufacturer’s declaration – electromagnetic immunity
The Fesia Walk device is intended for use in the electromagnetic environment specified below. The customer or user
of this device should assure that it is used in such an environment
Immunity test
IEC 60601 test
level
Compliance level
Electromagnetic environment guidance
Electrostatic Discharge (ESD)
IEC 61000-4-2
±6 kV Contact
±8 kV Air
±6 kV Contact
±8 kV Air
Floors should be Wood, concrete or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/bursts
IEC 61000-4-4
±2 kV for Power
supply lines
±1 kV for I/O lines
(input/output)
±2 kV for Power
supply lines
±1 kV for I/O lines
(input/output)
Mains power quality should be that of a typical
commercial and/or hospital environment.
Surges
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±1 kV differential
mode
±2 kV common mode
Mains power quality should be that of a typical
commercial and/or hospital environment.
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
<5% Ut
( >95% dip in Ut)
for 0,5 cycles
40% Ut
(60% dip en Ut)
for 5 cycles
70% Ut
(30% dip en Ut)
for 25 cycles
>5% Ut
(>95% dip en Ut)
for 5 sec
<5% Ut
( >95% dip in Ut)
for 0,5 cycles
40% Ut
(60% dip en Ut)
for 5 cycles
70% Ut
(30% dip en Ut)
for 25 cycles
>5% Ut
(>95% dip en Ut)
for 5 sec
Mains power quality should be that of a typical
commercial and/or hospital environment.
If the user of the Fesia Walk device requires continued
operation during power mains interruption, it is
recommended that the be powered from and
uninterruptible power supply.
Frequency (50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical
commercial or hospital environment.
Portable and mobile RF communications equipment should be used no closer to any part of the Fesia Walk
device, including cables, than the recommended separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance:
Conducted RF
IEC 61000-4-6
3 v
rms
150 kHz to 80 MHz
3 V
rms
d = 1,17 √P 150 kHz to 80 MHz
Radiated RF
IEC 61000-4-3
3 v/m
80 MHz to 2,5 GHz
3 V/m
d =1,17√P 80 MHz to 800 MHz
d=2,33√P 800 MHz to 2,5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m).
b
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less
than the compliance level in each frequency range. b
Interference may occur in the vicinity of the equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: Ut is the AC mains voltage prior to application of the test level.
Note 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic environment due to
fixed 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.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Instructions for Use: Fesia Walk
32
8.5.3 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.
Rated maximum output
power of transmitter [W]
Separation distance according to frequency of transmitter [m]
150 kHz to 80 MHz
d = 1,17 √P
80 MHz to 800 MHz
d =1,17√P
800 MHz to 2,5 GHz
d=2,33√P
0,01
0,12
0,12
0,23
0,1
0,37
0,37
0,74
1
1,17
1,17
2,33
10
3,70
3,70
7,37
100
11,70
11,70
23,30
For transmitters rated at a maximum output power nor listed above, the recommended separation distance d in meters
(m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output
power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Notes:
• 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
33
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
Fesia Technology SL
Pº Mikeletegi 1
E-20009 Donostia
SPAIN
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