Intended Use; User Population; Contraindications; Operator - LINET Image 3 B Instructions For Use And Technical Description

3 Intended use

The intended use is the hospitalization of the patient in the acute and long-term care units, which includes above all the
following aspects:
► Adjustment of the specific positions needed for the preventive reasons, routine nursing, treatments, mobilization, physio-
therapy, 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.

3.1 User population

► Adult overweight patients in the standard care units (based on individual patient status assessment by caregiver the pati-
ent can utilize dedicated device functions)
► 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)

4 Incorrect Use

Image 3 B is not suitable for:
■ Use
□ Other than described in the instructions for use
NOTE For information concerning uses other than those outlined in the "Intended use" section above, please contact LINET®.
LINET®'s efforts in research, design and manufacture ensure LINET® products are of the highest quality and fit
for their intended purpose. However, LINET® can take no responsibility for any damage to the products or any harm to patients,
staff or other individuals resulting from:
► Not following the instructions in the manual, including warning notices.
► Using the product for a purpose other than the intended purpose stated in the relevant documentation provided by
LINET® (see Intended use).
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