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1 Introduction
Always read the user manual prior to use.
1.1 General information
These systems are medical devices with CE-marking in accordance with MDD 93/42/EEC.
According to statutory regulations made by the authorities regarding medical devices, the
manufacturer the manufacturer is required to report all accidents incidents involving there
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
systems has been tested and approved according to the following standards: SS 876 00 01, SS
876 00 02, SS 876 00 04, SS 876 00 11, SS 876 00 20, SS-EN ISO 12182, SS-EN ISO 14971, SS-EN
ISO 10993-1, EN 14126, EN 597-1, EN 597-2.
1.2 Intended use
Optimal Standard mattresses are hygiene mattresses and are used in all kinds of caring envi-
ronments. They are replacement mattresses except PRIMA BM that is an overlay mattress.
PRIMA 6 is a reversible distance/elevation pad.
We recommend that position changes are made regularly. The time interval must be evaluated
by responsible personnel, depending on the patient´s status, diagnosis and general condition.
Mattresses with the Evac-cover have handles and Velcro straps for emergency evacuation. If
the cover has side handles, these are intended for lifting the empty mattress. All other use is
at your own risk and is not covered in the product guarantee.
1.3 Other information
Action plan Pressure ulcers
To achieve the best possible result for these products it is recommended that a well-planned
and well-structured working environment be used. In our guideline "Action plan" you will find
examples which can be applied and put into practice when using our products.
Mattress guide
This practical guide gives you as a care giver, help in choosing the correct mattress from the
Care of Swedens range. Optimal mattresses are mattresses in function group A. This
information can be found on our website www.careofsweden.com or you can order a copy
from our Customer services by sending your details to info@careofsweden.se.