3
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
The mattress is intended to be used for prevention and as an aid in alleviation of pressure
ulcers and pressure injuries (PU/PI).
1.3
Intended user
The mattresses are intended to be used by all kind of users, including lay persons.
1.4
Intended use environment
The mattresses are intended to be used in all kinds of healthcare environments,
including home care.
1.5
Indications
Suitable for persons with increased risk for pressure ulcers/injuries (PU/PI).
1.6
Contraindications
There are no known contraindications.
1.7
Clinical benefit
The clinical benefit for the mattresses included in this instruction for use are:
• Safety
• Comfort
• Easy to handle
