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D9U001MC0-0101_1618

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 specic positions needed for the preventive reasons, routine nursing, treatments, mobilization,

physiotherapy, examinations, sleeping, and relaxation. These positions are further specied and described in the clinical

evaluation of this device, together with their potential clinical outcomes and benets.

► 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/benet ratio. The relevant safety issues are the

part of the risk management le.

► Patient in-bed indoor transport out of the patient room.

► Providing the suitable working conditions for the caregivers to perform the routine and specic 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 specic 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)

LINET Multicare User Manual

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