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

1. Introduction

CuroCell S.A.M.® PRO is a static air mattress that can be used in all kinds of caring
environments and it is very functional and cost effective.
Always read the user manual prior to use.
1.1 General information
This system is a medical device with CE marking 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 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.
This system has been tested and approved according to the following standards: EN 60601-1,
SS-EN ISO 12182, SS-EN ISO 14971, SS-EN ISO 10993, EN 597-1, EN 597-2 and EN 14126.
1.2 Intended use
CuroCell S.A.M.® PRO can be used in all types of medical environments and is intended to
assist in the prevention and treatment of pressure ulcers, up to category 3
also be used as an aid in pain therapy. CuroCell S.A.M.
designed for continuous use.
1.3 Variants
The product is available as a mattress overlay (CuroCell S.A.M.® PRO, CuroCell S.A.M.® PRO
CF10) to be placed on top of an existing mattress or as a combi mattress (CuroCell S.A.M.® PRO
CF16), with an integrated foam core, that is placed directly on the bed base.
The recommended user's weight for this system is up to 250 kg.
We recommend that position changes are made regularly. The time interval must be assessed
by the responsible personnel, depending on user's status, diagnostic and general condition.
The mattress must always be cleaned between users.
NOTE:
• When used together with positioning pillows, read the pillow user manual carefully for
correct positioning of the user.
• If you are using this product with an evacuation sheet, it is the user's responsibility to
ensure that it is safe to use for evacuation.
• Remember that the underlying mattress is important for the product's functionality.
• The mattress is unsuitable for X-ray examinations because of the risk of blurred images
or artefacts that may lead to diagnostic errors.
• Do not store or use the product in direct sunlight. The product may be damaged by the
elevated temperature and UV light.
(1) National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury
Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media:
Osborne Park, Western Australia; 2014.
PRO is a static air mattress system
®
4
. The system can
(1)