D9U001ES2-0101_02
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3 Intended use (Sprint 200 without scales)
The intended use is the short term hospitalization of the patient in the emergency departments and one day care de-
partments, or other applicable departments, which includes above all the following aspects:
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Patient transport in the stretcher in the indoor environment. For the outdoor environment specific precautions in the in
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structions for use are valid.
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Adjustment of the positions needed for the, examinations, treatments, physiotherapy, sleeping, relaxation, preventive and
mobilization reasons, routine nursing. These positions are further specified and described in the clinical evaluation of this device,
together with their potential clinical outcomes and benefits.
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Providing the safe environment for the patient during all relevant procedures. The particular requirements on patient safety
are the subject of the clinical evaluation, including evaluation of the risk/benefit ratio. The relevant safety issues are the part of the
risk management file.
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Providing the suitable working conditions for the caregivers to perform the routine and specific tasks during the patient
hospitalization.
3.1 User population
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Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the emergency and one day care units (Application Envi
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ronment 1, 2 and 5 as in IEC 60601-2-52)
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Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)
3.2 Contraindications
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The medical device is not intended for the pediatric patients use.
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The medical device is not intended for the use with patients exceeding the Maximum Patient Weight and whose body
constitution is disproportionate to the size of Mattress Support Platform.
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The medical device is not intended for the long-term hospitalization with respect to dimensional parameters of the device
and the used mattress.
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Certain positions are not suitable for specific diagnoses/medical conditions (e.g. spinal cord injuries vs. Fowler position,
higher ICP patients vs. Trendelenburg). Staff expert assessment / nursing consideration is needed in all individual case of contrain
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dication.
3.3 Operator
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Caregiver
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Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)