Intended Use; User Population; Contraindications; Operator - LINET Multicare LE Instructions For Use And Technical Description

3 Intended use

The intended use is the hospitalization of the patient in the intensive and acute care units, which includes above all the
following aspects:
► Adjustment of the specific positions needed for the preventive reasons, routine nursing, treatments, mobilization,
physiotherapy, examinations, sleeping, and relaxation. These positions are further specified and described in the clinical
evaluation of this device, together with their potential clinical outcomes and benefits.
► 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.
► Patient in-bed indoor transport out of the patient room.
► Providing the suitable working conditions for the caregivers to perform the routine and specific tasks during the patient
hospitalization.
► Indicative measurement of the patient weight, used as supportive feature without direct diagnostic effect. It helps staff to
assess the general patient status and apply the nutrition and medicaments (valid for the version of the beds with in-bed
scales).

3.1 User population

► Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the intensive and acute care units (Application
Environment 1 and 2 as in IEC 60601-2-52)
► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)

3.2 Contraindications

► The medical device is not intended for the pediatric patients use.
► 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
contraindication.

3.3 Operator

► Caregiver
► Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)
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