D9U001ES1-0101_0814
3 Intended use (Sprint 100)
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► Patient transport in the stretcher in the indoor environment. For the outdoor environment specic precautions in the in-
structions for use are valid.
► Adjustment of the positions needed for the, examinations, treatments, physiotherapy, sleeping, relaxation, preventive and
mobilization reasons, routine nursing. These positions are further specied and described in the clinical evaluation of this device,
together with their potential clinical outcomes and benets.
► 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.
► 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 emergency and one day care units (Application Envi-
ronment 1, 2 and 5 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.
► The medical device is not intended for the use with patients exceeding the Maximum Patient Weight and whose body
constitution is disproportionate to the size of Mattress Support Platform.
► The medical device is not intended for the long-term hospitalization with respect to dimensional parameters of the device
and the used mattress.
► 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 Intended use (Sprint 100 mattresses)
The intended use is provide basic support surface for patient being treated on LINET’s sprint range of Stretchers only. They are
designed to provide comfort and reduce likelihood of pressure ulcers during short term use. The use of these mattresses does not
remove the need for regular repositioning in line with best clinical practice (ref: NPUAP, EPUAP).
4.1 User population
► Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the emergency and one day care units (Application Envi-
ronment 1, 2 and 5, as in IEC 60601-2-52)
► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)
4.2 Contraindications
► patient with higher risk of pressure ulcers than the mattress is designed for
► patients with higher weight than mattress weight limit
► patient’s showing signs of pressure related tissue damage should be stepped on onto an alternative support surface ba-
sed on risk assessment, clinical reasoning and best clinical practice (EPUAP, NPUAP guidelines)
4.3 Operator
► Caregiver
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