Care of Sweden CuroCell S.A.M., Инструкция по эксплуатации

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1. Introduction
CuroCell S.A.M.® is a constant low pressure reactive air mattress system that can be used in all
kinds of caring environments and it is very functional and cost effective.
Always read the instructions for use prior to use.
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 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 are used for prevention and as an aid in the
treatment of pressure ulcers/pressure injuries (PU/PI). The system can also be used in pain
therapy.
1.3 Indications
For users with pressure ulcers/pressure injuries (PU/PI) up to and including category 2 ¹. 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 three
versions. CuroCell S.A.M.® and CuroCell S.A.M.® CF10 are overlay mattresses and are placed
on an underlying mattress. CuroCell S.A.M.® CF16 is a replacement mattress placed directly on
the bed base. The recommended user weight is up to 200 kg.