LINET D9U001F10-0101, Инструкция по использованию и техническое описание, Страница: 13 / 46

D9U001F10-0101_06 13
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 patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the acute and long-term care units (Application Environ -
ment 2 and 3, 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 contrain -
dication.
3.3 Operator
► Caregiver
► Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)
4 Incorrect Use
Praktika 1 is not suitable for:
■ Patients
□
Not fulfilling conditions stated in chapter Intended Use.
■ Use
□ Home care
□ 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 indivi -
duals resulting from:
► Not following the instructions in the instructions for use, 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).