Fesia Fesia Walk User manual

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: [e-mail]
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
1General 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
2Symbols and definitions ........................................................................ 3
3Fesia Walk system description .............................................................. 5
3.1 General description..............................................................................................................................................5
3.2 System components.............................................................................................................................................6
4Fesia 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
5Software 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
6Maintenance and cleaning.................................................................. 26
6.1 Transport ............................................................................................................................................................26

6.2 Disposal of equipment and accessories............................................................................................................26
7Troubleshooting.................................................................................. 27
8Technical 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
9Contact information............................................................................ 33

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1GENERAL 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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2SYMBOLS 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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3FESIA 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 multi-
field 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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4FESIA 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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5SOFTWARE 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: