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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:
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Adjustment of the specific positions needed for the preventive reasons, routine nursing, treatments, mobilization, physio
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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.
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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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Patient in-bed indoor transport out of the patient room.
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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 acute and long-term care units (Application Environ
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ment 2 and 3, 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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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)
4 Incorrect Use
The bed is not suitable for:
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Patients
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Not fulfilling conditions stated in chapter “Intended 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 make sure LINET® products are of the highest quality and fit for their inten
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ded purpose. However, LINET® can take no responsibility for any damage to the products or any harm to patients, staff or other
individuals resulting from:
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Not following the instructions in the manual, including warning notices.
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Using the product for a purpose other than the intended purpose stated in the relevant documentation provided by
LINET® (see Intended use).