Care of Sweden Curera 2022-06-09, Инструкция по эксплуатации

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2
1 Introduction
Always read the instructions for use prior to use.
1.1 General information
The product is a medical device with CE marking in accordance with MDR (EU) 2017/745.
According to this regulation the manufacturer is required to report all accidents or incidents
involving the products. All information involving accidents or incidents relating to our
products, shall be reported immediately to Care of Sweden.
1.2 Intended purpose
Curera® seat cushions are intended to be used for positioning, as an aid for prevention of
pressure ulcers/pressure injuries (PU/PI).
1.3 Intended user
Curera® seat cushions are intended to be used by all kind of users, including lay persons.
1.4 Intended user environment
Curera® seat cushions are designed to be used in wheelchairs and on furniture, for pressure
redistribution and positioning, in all kinds of healthcare environments, including home care.
1.5 Indications
For users having difficulty maintaining a stable seated position.
1.6 Contraindications
There are no known contraindications.
1.7 Clinical benefit
The clinical benefit for Curera Seat cushions included in these instructions for use are:
• Pressure redistribution
• Safety
• Comfort
•
Easy to handle