Introduction - Care of Sweden CuroCell S.A.M. PRO User Manual

1. Introduction

CuroCell S.A.M.® PRO is a constant low pressure reactive air mattress system that can be used
in all kinds of healthcare environments.
Always read the instructions for use prior to use.
For further questions regarding installation, use or maintenance please contact Care of
Sweden or your local distributor.
1.1 General information
This system is a medical device with CE marking in accordance with MDR (EU) 2017/745.
The system has been fully or partially designed and verified in accordance with the standards
listed in section 8.2. Standards.
According to statutory regulations made by the authorities regarding medical devices, the
manufacturer is required to report all accidents or incidents involving the products. We would
be very grateful for all information involving accidents or incidents relating to our products, by
reporting them immediately to us, at Care of Sweden.
1.2 Intended use
The system consists of a pump and a mattress and is intended to be used as an aid for
prevention and in the treatment of pressure ulcers/pressure injuries (PU/PI).
1.3 Indications
Suitable for a wide range of persons with increased risk for pressure ulcers/injuries, including
those with superficial ulcers, up to category 3 (in association with an individualised plan of
care)¹. The mattress system is available in three versions.
S.A.M.® PRO CF10 are top mattresses and are placed on an underlying mattress.
S.A.M.® PRO CF16 is a replacement mattress placed directly on the bed base. The
recommended user weight is up to 250 kg.
1.4 Contraindications
There are no known contraindications.
1.5 Intended user
The mattress systems are intended to be used by all kind of users, including lay persons.
1.6 Intended use environment
The mattress systems can be used in all kinds of health care environments, including
homecare.
CuroCell S.A.M.® PRO and CuroCell
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CuroCell