zebris Medical GmbH FDM Technical Data and Operating Instructions Page 7/542 Scope and security2.1 Intended UseMain function of the force distribution measurement system FDM is the spatially resolvedforce distribution measurement under human feet for the analysis of static and dynamicstrains as well as the individual gait parameters.Operation as well as data evaluation and storage are software-aided by using a computer.The measuring systems are suitable for the use with patients that are mentally capable offollowing the operator’s instructions without limitations in the period of application.The patient’s weight is limited by the maximum permissible weight of the treadmill. For theapplication of the FDM-T with children or patients with severe movement disorders, a fallstop safety is strongly recommended.Professional facilities (medical practices, clinics, scientific institutions, rehabilitation centres,and orthopaedic specialist shops) are specified as application environment.The application and operation of the system may only be carried out by thoroughly trainedqualified personnel such as clinical doctors, physiotherapists, orthopedics which posses theability to evaluate the output data in medical aspects as a aid for the diagnosis, treatment orpatient care and taking into account the clinical history of the patient in the context of otherdiagnostic tests.2.1.1 Indications Stance and gait analysis of the “normal” as well as the pathological stance and gait. Diagnosis support with foot malpositions and foot corrections Diagnosis support and therapy of imbalances / incorrect gait pattern Detection of inappropriate mechanical stress and overstraining for the prevention of phys-ical problems and for rehabilitation with disabilities after injury, accidents or surgeries. Support with the development, adjustment and verification of orthopaedic aids for theindividual patient care Balance analysis and balance training Gait training in combination with dynamic visual stimulation (cueing) and feedback train-ing as therapy/rehabilitation measures after a surgery, stroke, with the Parkinson’s dis-ease as well as other neurologic and orthopaedic disorders Success control of therapy/rehabilitation measures2.1.2 Contraindications The FDM system must not be applied for a barefoot measurement with patients havingopen wounds and/or infections on the feet.