Introduction - Care of Sweden CuroCell 4 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 recovery or to
prevent skin damage.
Always read the user manual prior to use.
1.1 General information
This system is a medical device and is CE-marked 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 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® 4 is an alternating pressure relief mattress replacement system. The mattress can be
used in all kinds of caring environments to prevent pressure ulcers, as well as treatment up to
Category 4 pressure ulcers. The mattress is meant for use for persons of a recommended
(1)
minimum length of 120 cm. The recommended user weight is up to 200 kg. CuroCell® is a
replacement mattress and shall be placed directly on the bed frame. 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 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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