Introduction - Care of Sweden CuroCell AREA Zone Instructions For Use Manual

1. Introduction

Always read the user instructions for use prior to use.
1.1 General information
This CuroCell® mattress is a medical device in accordance to Medical Device Regulation
(2017/745). 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: SS-EN ISO 12182,
SS-EN ISO 14971, SS-EN ISO 10993, EN 597-1, EN 597-2, EN 14126.
Unprevented/untreated pressure ulcers/pressure injuries can very quickly deteriorate
resulting in higher risk of complications, pain and suffering for the user.
1.2 Intended use
The CuroCell® hybrid mattresses can be used for prevention and as an aid in the treatment of
pressure ulcers/pressure injuries (PU/PI).
1.3 Indications
For users with pressure ulcers/pressure injuries (PU/PI) up to and including category 3. As well
as for users in risk of PU/PI.
1.4 Contraindications
There are no known contraindications.
1.5 User application
CuroCell® AREA Zone can be used in all kinds of healthcare environments and is a full
replacement mattress to be used for users up to and including 230 kg.
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.
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