ADVERSE EFFECTS
•
Patients may feel irritation and skin burns under the stimulation
electrodes applied to the skin.
•
Patients may experience headaches and other painful sensations
during or after the application of electrical stimulation near the eyes,
on the head or the face.
•
Patients should stop using the device and consult a doctor if they
experience an adverse reaction.
•
Some patients may experience extra sensitivity or skin irritation due
to the electrical stimulation or the electrical conductor (Gel). Irritation
may be alleviated by using a different conductor or by placing
the electrodes differently.
•
Some patients may experience redness under the electrodes after
the session. This redness generally disappears within a few hours.
If skin redness persists after a few hours, the patient should consult
a doctor. Do not begin another stimulation session on the same area
if redness is still visible. Do not scratch red areas.
SAFETY MEASURES
•
Keep out of the reach of children.
•
Risk of electric shock.
•
Near other equipment. Do not use the device when it is placed
near to or above other equipment. If it is necessary to use it in such
a situation, make sure that ALL THE PERIPHERAL EQUIPMENT
IS OPERATING CORRECTLY under these conditions.
•
Do not use the device at the same time as monitoring equipment
(e.g. ECG equipment) that uses electrodes. The signals generated
by the device could interfere with those of the monitoring equipment.
•
Accessories. Use this device only with manufacturer-recommended
electrodes, probes and accessories. Using other accessories may
harm the performance of the device, increase electromagnetic
emissions or reduce the electromagnetic immunity of the device.
•
Do not modify. No modifications to the equipment are authorized.
•
Battery or stimulator heating up. Under extreme use conditions,
some parts of the casing may reach 43°C (109°F). Handle the battery
and hold the device carefully immediately after use. This temperature
may cause an unpleasant sensation but does not pose a particular
health risk.
•
Strangulation. Never wrap the wires around the patient's neck and
always keep out of the reach of children. Tangled wires may lead
to strangulation.
•
Falls. Pay attention to wires on the ground to prevent falls.
•
Damaged device or accessories. Never use the device or accessories
if damaged (casing, wires, etc.) or if the battery compartment is open
because there is a risk of electric shock. Carefully inspect the wires
and connectors before each use.
•
Foreign body. Do not allow any type of foreign body (dirt, water,
metal, etc.) to get into the device or the battery compartment.
•
LI-ION BATTERY. Do not carry the battery in a pocket, wallet or any
other place in which the terminals could cause a short-circuit.
This may generate intense heat and cause injury. Never open
the battery compartment cover during stimulation due to the risk
of electric shock. Remove the battery from the device if you do not
plan to use it for a long period, i.e., more than three (3) months.
Leaving the battery in the device for a long period may damage
the battery and the device.
•
To avoid damage to the wires, it is best to leave them connected
to the stimulator between two (2) sessions. Do not shake the wires
and connectors.
•
Equipment with internal power supply, type BF applied parts are
not suitable for:
_ Use in the presence of a flammable anaesthetic mixture with air,
oxygen or nitrous oxide.
_ Continuous use
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