Tremitas Tremipen, Instructions For Use Manual

Page: 17 / 42

The Tremipen® is intended to be used by the patients
themselves (lay person), since the intended functioning
requires the patient to hold the object.
Medical experts and professionals can assist during
the preparation or the implementation of the intended
operation.
The Tremipen® itself does not require special training
and knowledge, but the IfU must be understood and
complied with.
The Tremipen® shall only be used for the following
symptoms or diseases (according to
ICD-10-GM-2017
):
• G20.- (Primary Parkinson Syndrome)
• G20.- (Primary Parkinson Syndrome)
• G20.0 (Primary Parkinson Syndrome with
missing or low-level impairment)
• G20.1 (Primary Parkinson Syndrome with
moderate or high-level impairment)
• G25.0 (Essential Tremor)
• G25.2 (Other, not further specified forms of
tremor)
• Additionally, tremor as a symptom.
• The Tremipen® can be used in clinical
environments, such as hospitals and doctors’
offices, and in home environments.
• The Tremipen® is NOT meant to be used outdoors.
• The measurement process of the Tremipen® takes
approximately 30 seconds.
• Including the activation and other usability
features, the typical duration of use is still below
60 seconds.
• The Tremipen® is intended for multiple
applications.
4.2 User (Training, Knowledge)
4.3 Medical Indications
4.4 Where, how long and how often should
the Tremipen® be used?
Currently, no contraindications are known regarding
the use of the Tremipen®.
4.5 Contraindications
15