Care of Sweden CuroCell AUTO4, Инструкция по эксплуатации

Страница: 5 / 24

5
1. Introduction
CuroCell® air mattresses work according to the alternating pressure principle, a technique that
is thoroughly tried and tested and has been used for a long time. Alternating pressure means
that the pressure is alternated regularly between the cells in order to simulate the body’s own
movements. Periods are created in which the pressure is lower or completely absent. This
provides good conditions for the skin to recover and to prevent injury.
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 Medical Device Regulation
MDR (2017/745).
The system has been fully or partially designed and verified in accordance with the standards
listed in section 9.2. 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 are 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 4 and
unclassified PU/PI (unstageable and suspected deep tissue injury¹). As well as for users in risk
of PU/PI.
1.4 Contraindications
There are no known contraindications.
1.5 User application
The systems can be used in all kinds of health care environments. It is available in two
versions. CuroCell ® AUTO4 CX13 is an overlay mattress and is placed on an underlying
mattress. CuroCell ® AUTO4 is a replacement mattress placed directly on the bed base. The
mattress is intended to be used for people with a recommended minimum height of 120 cm
and a recommended user weight of up to 180 kg.