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2.1 Additional safety instructions for Extra Safe Bed
► Use of removable accessories (lifting pole, infusion stand, Protector, accessories on the accessory rail etc.) is not
recommended. Using this type of accessories must be considered by responsible personnel after evaluation of patient’s
health and mental condition.
► Hospital personnel must consider leaving handset at the bed and leaving bed in the mains while the patient is without
supervision. It is recommended for mentally unstable patients to remove handset and to lock mains cable to the box under
head board.
► Use of bed extension is not recommended for mentally unstable patients.
► Periodically check if the bed placed on the psychiatric department is not damaged. In case of any damage of the bed,
replace the damaged parts.
► Always check grounding of the bed in case the bed is equipped with grounding chain.
► Fixation of the bed to the floor must be done only by qualified personnel.
► Always fix the bed to the ground using 8 screws.
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,
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.
3.1 User population
►
Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the acute and long-term care units (Application
Environment 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
contraindication.
3.3 Operator
►
Caregiver
►
Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)
4 Incorrect Use
Eleganza 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
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).