Safety; Contraindications And Side Effect; Contraindications; Side Effects - Winback Back4 Manuel Utilisateur

2. SAFETY

2.1 CONTRAINDICATIONS AND SIDE EFFECTS

2.1.1 Contraindications

The practitioner must refrain from any treatment for the following cases:
• Pregnant women
• Minor
• Cancer and cancerous lesions
• Skin disorders (Eczema, Shingles) - Skin burns - Open wounds
• Coagulation disorders – Phlebitis – Thrombophlebitis
• Insensitivity to heat
• Local insensitivity to pain and/or touch
• Fever – Bacterial infection – Infectious disease
• Severe hypertension or hypotension
• Electrical implants (pacemaker, insulin pump, neurostimulator)
The practitioner must refrain from any treatment involving direct application (direct contact with the electrode)
on the following areas: the brain area, the eyes and around the eyes, and the heart area. We recommend the practitioner
to make patients sign an informed consent before the first treatment. You should inform the patient about how the
device works, the expected benefits, possible side effects, warnings, precautions and contraindications.

2.1.2 Side effects

• In some cases, a transient increase in pain may be felt within 24 hours after the session if the intensity is too
high. This feeling fades spontaneously. In this case, it is advisable to work in athermal mode (low intensity)
during the first three sessions.
• In very rare cases, the patient may be subject to an allergy to the conductive cream or superficial burns.
• In rare cases when the entire body is being treated, reactive hypotension my be observed. If the patient is
lying down, be sure to raise them gradually after the treatment. In case of marked hypotension, hyperthermia
is not recommended.
Important notes:
Prefer athermal treatments in the following cases:
• In case of treatment on a bone area (the thermal effect being faster).
• In case of anatomical vascular damage.
• In case of major inflammation, during the first three sessions.
In the event of any serious incident occurring in connection with the device, please inform the SWIMS S.A.S./WINBACK
company by contacting the customer service (sav@swims.team). SWIMS S.A.S./WINBACK will then inform the
manufacturer and the competent authority of the Member State in which the user and/or the patient is based.

2.2 PRECAUTIONS FOR USE

Operation:
• Do not operate the device when treating patients who are connected to other equipment.
• The accessories must always be entirely in contact with the patient's skin.
• Never use a sharp or pointed object like the tip of a pen or pencil on the screen.
• The accessories must be used with care. Inappropriate handling may damage them and impact their
proper functioning.
• Check the device and all its accessories before each use.
• The device should only be used under the constant supervision of a trained and authorized practitioner.
• You must have been trained by an authorized person from SWIMS S.A.S./WINBACK before using the
device.
• Keep the device out of the reach of children.
• Improper use of the controls or settings, or the carrying out of procedures other than those specifie
herein, may result in damage to the equipment or its accessories.
• Choose the position of the neutral electrode carefully. Never place the return plate on an area of the
patient's skin that is delicate or in a bony area.
• The values displayed on the main screen may vary between +/-10%.
• The emergency stop button must always be plugged in and accessible to the patient.
• Always make sure that the patient does not have any contraindication before using the device.
• To use hands-free mode with fixed electrodes, take care not to exceed an intensity of 40% and use LOW
mode.
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