Introduction
1.3 Applications
1.4 System description
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Use
•
The device is intended for use by physicians or medical professionals.
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Use the device in a clean treatment room.
•
Position the device on a flat, straight floor surface.
•
Frequency of use: Can be used daily.
•
Mobility: There are four wheels on the underside of the device for transport.
Applications
1.3 Applications
High-frequency therapy is a method of electrotherapy for the reliable relief of
musculoskeletal pain. It generates deep heat (diathermy) in the body using high-
frequency alternating current. The high-frequency therapy with the reModel device is
indicated in a variety of indications, for example, in painful diseases of the
musculoskeletal system or in chronic inflammation. (Source: pschyrembel.de, keyword
“high
-
frequency therapy”)
The many preset, indication-based treatment programs make the treatment easy and
safe.
Side effects
1.3.1 Possible side effects
Swelling, burns, erythema
System description
1.4 System description
1.4.1 Classifications
In accordance with the directive for medical devices, the high-frequency therapy
device corresponds to class IIa in accordance with appendix IX rule 9.
In accordance with EN60601-1 (2007) the following classifications are used:
Protection against electric shock Class I ME device.
Applied part of type BF
Sterilisation method: not applicable.