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 the treatment of pressure
ulcers/pressure injuries (PU/PI).
1.3
Intended user
The mattress is intended to be used by all kind of users, including lay persons.
1.4
Intended user environment
The mattress is intended to be used in all kinds of healthcare environments, including home
care.
1.5
Indications
Suitable for a wide range of persons with increased risk for pressure ulcers/injuries, including
those with superficial ulcers, up to and including category 3 (in association with an
individualised plan of care). The user weight is up to 230 kg.
1.6
Contraindication
There are no known contraindications.
1.7
Clinical benefit
Care of Sweden’s clinical benefits and claims for CuroCell® hybrid mattresses consist of
•
Safety
•
Comfort
•
Pressure redistribution
•
Easy to handle
Note!
• When used together with positioning pillows, read the pillow instructions for use
carefully for correct positioning of the user.
• If you are using this product with an evacuation sheet, it is the user’s responsibility to
ensure that it is safe to use for evacuation.
• The mattress must not be lifted with a person lying on it or used for any other type of
transport other than a possible evacuation using an evacuation sheet.
