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1 Introduction
Always read the instructions for use prior to use.
1.1 General information
This product is a medical device and is CE-marked according to MDR (EU) 2017/745. Accord-
ing to statutory regulations made by the authorities regarding medical devices, the manufac-
turer is required to report all accidents or incidents involving their products. We would be very
grateful for all information involving accidents or incidents relating to our products, by report-
ing them immediately to us here at Care of Sweden.
1.2 Intended use
The preventative support surface/-s can be used as aid for prevention and in the treatment of
pressure ulcers/pressure injuries (PU/PI).
1.3 Indications
Suitable for a wide range of persons with increased risk for pressure ulcers/injuries, including
those with superficial ulcers, up to category 1-2 (in association with an individualised plan of
care). The Optimal 5zon®, Optimal 5zon® Plus, Optimal Care, Optimal Cura, Optimal Mono,
Optimal Solett, Optimal Maxx and Prima 12 mattresses are replacement mattresses to be
placed directly on the base of the bed. Optimal 5zon®BM and Optimal Solett BM are overlay
mattresses to be placed on top of an existing mattress.
1.4 Contraindications
There are no known contraindications.
1.5 Intended user
The mattress systems are intended to be used by all kind of users, including lay persons.
1.6 Intended use environment
The mattresses can be used in all kinds of health care environments, including home care.
1.7 Other information
Action plan Pressure ulcers/pressure injuries
For the best possible results when using this product, we recommend a structured and
planned approach. Examples that can be applied to the use of our products can be found in
the ‘Action plan for pressure ulcers’ guidelines.