Bemer Therapy System Evo Instrucciones De Uso página 8

2.1.8 Intended patient group
The device is intended for use on people aged 14 years or older in accordance with the respective
indications for use and contraindications.
Children under 14 years of age and individuals with impaired physical, sensory or mental capabilities
must be supervised and / or instructed by a suitable person who accepts responsibility for their safety.
2.1.9 Body regions
The body region to be treated is defined by the applicators.
The whole-body applicators (B.Body Evo and B.Bed Evo) are designed for systemic application of
the PEMF therapy. Due to the distribution of the coils, all regions of the body are reached by the
magnetic field.
The local applicators (B.Spot Evo, B.Pad Evo and B.Sit Evo) are optionally used for targeted application
of the magnetic field in specific areas of the body.
The LLLT applicators are optionally used for targeted application of LLLT on specific areas of the body.
2.1.10 Intended environment and field of application
The product is intended exclusively for the application of PEMF and LLLT in conjunction with the
applicators by laypersons in a home environment and by professional users in a clinical setting.
The PEMF applicators and LLT applicator modules, in combination with the B.Box Evo, are intended
for use by laypersons in a home environment and by medically trained personnel in a clinical or
outpatient setting.
2.2 Clinical benefits
The B.Box Evo itself has no clinical utility.
Users of PEMF therapy benefit from improved blood flow to the capillary network, in particular in
the smaller and smallest blood vessels, and thus from improved tissue supply, which is desirable
for various health conditions.
The application of LLLT using the B.Light Clear Evo leads to an improvement in the skin's appearance,
especially in cases of mild to moderate acne vulgaris.
The application of LLLT using the B.Light Restore Evo leads to an improvement in the skin's appearance.
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2.3 General safety instructions
WARNING
Interference with active implants due to electromagnetic forces (PEMF)
Active implants (e.g., pacemakers, insulin pumps, etc.) may be disrupted by electro-
magnetic forces.
z Do not use the BEMER Therapy System Evo (PEMF) under any circumstances if
you are a patient with an active implant.
Risk of strangulation due to loose cables
Loose cables and leads pose a risk of injury, e.g., caused by tripping or strangulation.
z Lay the cables flat to ensure they do not create a tripping hazard.
z Use the supplied fastening aids to lay the cables.
Risk of burns due to damaged or worn out B.Box Evo Battery Stand
The failure of safety mechanisms may lead to spontaneous combustion or explosions.
z Never open or use lithium batteries or accumulators that are swollen, deformed,
outgassed, have "leaked", or are covered with a "greasy film" or external deposits in
the area of the poles are damaged. Damaged batteries are associated with an
increased hazard risk.
z Therefore, dispose of these batteries and rechargeable batteries immediately,
preferably at an electronics store or recycling center – and in a manner that ensures
that the staff there can accept them.
z Speak to the qualified personnel there and point out the damage.
Life-threatening hazards due to non-compliance with the safety instructions
Failure to follow the instructions for use correctly may result in operating errors and
life-threatening hazards.
z Always read and familiarize yourself with the instructions for use included
in the scope of delivery.
z Observe the safety notes.
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