file: n:\article\cos101676-en\20210629_cos101676-en_hpcosmos_airwalk_ap_unweighting_ifu_iim_manual.docx
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3.
Intended use
3.1.
Intended use
N
Body weight support of a subject (during treadmill therapy / training)
N
Fall protection of a subject (during treadmill therapy / training)
N
Emergency stop in case of falling during treadmill therapy / training
N
Balance training under unweighted and/or secured conditions
N
Functional movement and gait training under unweighted and/or secured conditions
N
Overspeed / hyperspeed and excess frequency training in athletics (only for sports applications)
Prescribed fall prevention device for any application where falling might cause an unacceptable risk (e.g. high speed or
special applications, applications with subjects not able to support their weight properly, physically impaired, newly
operated hip patients, invasive probes, osteoporosis, etc.)
3.2.
Intended operator
N
Medical staff only
N
that has been carefully trained according to these instructions for use
N
that is working according to the prescription of the medical doctor, where applicable and necessary
N
The subject is not the intended operator.
But the intended operator is authorized to allow the subject to control the device according to the instructions of the intended
operator and under the permanent observation of the intended operator.
This means the operation of the device remains the responsibility of the intended operator at all times, taking the physical
and mental condition of the subject into account.
The intended operator has to be within reach of at least one emergency stop / off at all times
3.3.
Intended location
N
Medical facilities only
N
No use at home or in home healthcare environments (acc. to IEC 60601-1-11)
N
No outdoor use
N
No direct sunlight
N
Sufficiently lighted for proper readability of warning, labels, displays and operation elements
N
Proper environmental conditions (see “Technical Data”)
N
Stationary training equipment: Not moved during use
3.4.
Intended duration
N
Depending on the prescription of the medical doctor
3.5.
Contraindications
Absolute contraindications
(have to be excluded before the treadmill is used)
N
Acute myocardial infarction (within 2 days)
N
Instable angina pectoris
N
Cardiac arrhythmia pathology and/or limited hemodynamics
N
Symptomatic massive aortic stenosis
N
Uncompensated / uncontrolled heart insufficiency
N
Acute pulmonary embolism or pulmonary infarction