Safety; Intended Age Of Use; Indications For Use; Contraindications - Bemer Evo Manual De Instrucciones

2. SAFETY

BEMER products may only be used for the purposes described in this chapter. Any use of the
product beyond the scope of the intended use is regarded as improper.

2.1 INTENDED AGE OF USE

The device is intended for use by patients aged 18 years or older who have the necessary
capabilities and experience to read and understand the instructions for use.

2.2 INDICATIONS FOR USE

To temporarily increase local blood circulation in healthy leg muscles
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To stimulate healthy muscles in order to improve and facilitate muscle performance
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2.3 CONTRAINDICATIONS

Individuals fitted with active medical implants (e.g., medication pumps, pacemakers)
―
Recipients of organ transplants, allogeneic cell transplants, bone marrow or stem cell
―
transplants in combination with immunosuppressive therapy
(= intentional suppression of the immune system)
Do not use the device if you have been diagnosed with deep-vein thrombosis (DVT)
―

2.4 SIDE EFFECTS

When applied via the corresponding applicators, the following short-term side effects may
occur in very rare cases:
Change in pulse rate
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Change in blood pressure
―

2.5 BODY REGION

Depending on the applicator, different forms of application are possible:
B.Body Evo and B.Bed Evo are used for treatment on lower extremities and upper torso.
―
B.Pad Evo, B.Sit Evo, and B.Spot Evo are additionally used for local treatment.
―
The B.Grip Evo holder module is required for use of the B.Spot Evo.
―

2.6 INTENDED ENVIRONMENT

The applicators and 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.
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