Introduction; General Information; Intended Use - Care of Sweden CuroCell NEO 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 system is a medical device with CE-marking in accordance with 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 their 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® NEO CX is an alternating pressure mattress that can be used in all kinds of health
care environments, to prevent pressure ulcers, as well as treatment up to and including
category 4 pressure ulcers. It is available in two versions, as an overlay (CuroCell® NEO CX13)
(1)
or as a mattress replacement (CuroCell® NEO CX19). The mattress is meant for use for persons
of a recommended minimum lenght of 120 cm. The recommended user weight is up to 160 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.
We recommend that position changes are made regularly. The time interval must be evaluated
by the responsibel personnel, depending on the patient´s status diagnosis and general
condition.
The mattress must always be cleaned between patients.
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