Winncare PITCHOUNE KALIN, Руководство пользователя

Страница: 5 / 36

5
The user and staff must be trained and aware of the risks associated with
using the bed. He must not allow it by children and be vigilant when used by
confused or disoriented people.
3.1.2. Indications
Suitable for patients with temporary or permanent decreased independence due to their illness or disability.
3.1.3. Contraindications
To be determined by the prescribing doctor based on the patient’s condition, the medical treatment and the
type of relevant accessories. Patient weight higher than the safe operating load defined.
3.2. Clinical benefit, device performance, action mechanism depending on the functions,
options or accessories used
3.2.1. Device performance characteristics
Variable height (ergonomics of care, transfer aid), low bed (reduces the severity of falls from the bed),
Trendelenburg, reverse Trendelenburg, chest rest, leg rest, flat, chair position (preserves or improves the
patient’s physical and/or psychological state, helps with administering care), 30° chest rest and/or with Fowler
or semi-Fowler positions (helps prevent pressure sores), According to our bed models 5° Trendelenburg (helps
lift the patient), rails (protects the patient and/or caregivers), lateral stop (stabilizes the mattress), removable
bed panels (prevents the patient from falling out of bed, acts as a fixed walking aid, helps with head and foot
care).
3.2.2. Expected clinical benefits
To preserve the patient’s state of health, mobility, activity and transfers. To reduce the repercussions of the
immobilization syndrome. To protect the health and safety of users or others.
3.2.3. Information for healthcare professionals
Identify possible combinations of risks and benefits for each intended use. Assess the patient’s ability to use
and understand the overhead remote control and the caregivers’ knowledge of how the medical bed and its
accessories work.
Any serious incident occurring in connection with the device must be reported to the manufacturer and to the
competent authority of the Member State in which the user and/or patient is established. Inform the competent
authority if you think or have a reason to believe that the device presents a serious risk or is faulty.
3.3. Precautions for use
Although the bed is conforming with Electromagnetic Compatibility, some devices may alter how it functions,
in which case they must be used at a distance or not used at all.
The bed is a medical device and must not be modified under any circumstances. You must ensure its
traceability, including that of the boards and its accessories.
If you assemble medical devices not provided by the supplier, you shall meet the manufacturer's general
obligations in accordance with Article 10 of Regulation (EU) 2017/745.