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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 Medical Device Regulation MDR
(2017/745). According to statutory regulations made by the authorietes 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.
1.2 Intended use
CuroCell® Nova is an alternating pressure mattress system that can be used in all kinds of
caring environments to prevent pressure ulcers, as well as treatment up to and including
category 2
(1)
. CuroCell® Nova is a mattress overlay system to be placed on top of an existing
mattress. We recommend that position changes are made regularly. The time interval must be
evaluated by the responsibel personnel, depending on the users 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.
