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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 mattresses are intended to be used by all kind of users, including lay persons.
1.4
Intended user environment
The mattresses are 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 included category 3 (in association with an
individualised plan of care). The mattress system is available in three versions. CuroCell
S.A.M.® PRO and CuroCell S.A.M.® PRO CF10 are top mattresses and are placed on an
underlying mattress. CuroCell S.A.M.® PRO CF16 is a replacement mattress placed directly on
the bed base. The recommended user weight is up to 250 kg
1.6
Contraindication
It is necessary for the prescriber of the mattress to make an individual assessment of the user
and decide whether the characteristics of the mattress is beneficial for the user based on
diagnosis.
1.7
Clinical benefit
Care of Sweden's clinical benefits and claims for CuroCell® CLP reactive air mattresses systems
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.
• Remember that the underlying mattress is important for the product's functionality.
• Do not store or use the product in direct sunlight. The product may be damaged by the
elevated temperature and UV light.
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