D9U001EZ3-0101_0024
3 Intended use of the Essenza 300 Medical Bed
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 specic positions needed for the preventive reasons, routine nursing, treatments, mobilization, physio-
therapy, examinations, sleeping, and relaxation.
► 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/benet 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 specic 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), alternatively in Application Environment 1 and 5
► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)
3.2 Contraindications
► The medical device is not intended for the pediatric patients use.
► Limited patient handling leads to development of pressure injury.
► Certain positions are not suitable for specic diagnoses/medical conditions (e.g. spinal cord injuries vs. Fowler position,
higher ICP patients vs. Trendelenburg). Sta 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 Product Description
Following pictures show basic visible features of the Essenza 300 medical bed in Essenza 300 with Lateral Tilt conguration and
Essenza 300 without Lateral Tilt conguration together with 3 types of the siderails.
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