Fesia F0X6-XM, Instructions For Use Manual

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INDICATIONS OF USE
CONTRAINDICATIONS
- Do not use the device with people with
cardiac pacemakers or other electrical or metallic implants
, unless recommended by a
doctor or clinical staff.
- Do not use the device with people with
severe epilepsy
or a recent history of frequent seizures.
- Do not use the device with people with
tumors or cancerous lesions in the area
where electrical stimulation is applied.
WARNINGS
- Do not use the 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.
- Do not use this
device simultaneously with other medical devices
. Ignoring this warning can result in
skin burns
in the electrode
are and could damage the stimulator.
- Do not use this device in
less than one meter away
from shortwave or microwave therapy equipment. Ignoring this warning could
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 faulty device
may cause
skin burns, muscle damage or falls
.
PRECAUTIONS
- The device must be used
under the supervision of a physician or clinician, physiotherapist or care giver
and may only be oper -
ated 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 or 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
.
- 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
.
- The
electrode is personal
, it should not be exchanged between different people.
- Make sure the
stimulator and 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.
ADVERSE REACTIONS
- Electrical stimulation could cause an
uncomfortable feeling or very mild pain
in the first uses 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 disap -
pear 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
within the area of stimulation application.
- Feel a
significant increase
in muscle
spasticity
.
- Suffer from
tachycardia or cardiac rhythm disturbances
during stimulation.
- It has swelling of the leg, knee, ankle or foot.
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 nervous system disease or injury.
Manufacturer must be informed of any serious incident involving the use of this product. !
GENERAL INFORMATION
01 01
GENERAL INFORMATION
INSTRUCTIONS FOR USE |
Fesia
Walk 09
08 INSTRUCTIONS FOR USE |
Fesia
Walk