Introduction - Care of Sweden CuroCell Nova CX13 User Manual

1. Introduction
CuroCell® air mattresses operate according to the alternating pressure principle, a technique
that is well proven and been used for a long time. Alternating pressure is when the pressure
regularly alternates between the mattress cells to replicate body movement. Variable pressure
cycles are set up where there is little or no pressure. This is optimal for skin improvement or to
prevent skin damage.
Always read the user manual prior to use.
1.1 General information
This CuroCell® mattress is a medical device in accordance to MDD 93/42/EEC. According to
statutory regulations made by the authorities regarding medical devices, the manufacturer is
required to report all accidents or incidents involving there products. We would be very
grateful for all information involving accidents or incidents relating to our products, by
reporting them immediately to us, here at Care of Sweden. The system has been tested and
approved according to the following standards: IEC 600601‐1, IEC 60601‐1‐2, SS‐EN ISO 12182,
SS‐EN ISO 14971, SS‐EN ISO 10993, EN 597‐1, EN 597‐2, EN 14126.
1.2 Intended use
CuroCell® Nova CX is an alternating pressure mattress system that can be used in all kinds of
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caring environments to prevent pressure ulcers, as well as treatment up to category 2
pressure ulcers. It is available in two versions, as an overlay (CuroCell® Nova CX13) or as a
replacement mattress (CuroCell® Nova CX19). We recommend that position changes are made
regularly. The time interval must be evaluated by the responsible personnel, depending on the
patient´s status diagnosis and general condition. The mattress is meant for use for persons of a
recommended minimum length of 120 cm. The recommended user weight is up to 150 kg.
The mattress should only be used lying in the lengthwise direction on the
mattress with the feet at the end marked with the feet symbol.
The mattress must always be cleaned between patients.
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