Standards And Regulations; Intended Use; Service Life - Invacare Essential Care User Manual

1.4 Standards and regulations

Quality is fundamental to the company's operation, working
within the disciplines of ISO 13485.
All Invacare mattress products feature the CE mark, in
compliance with the Medical Device Directive 93/42/EEC
Class 1.
Invacare is continuously working towards ensuring that the
company's impact on the environment, locally and globally,
is reduced to a minimum. We only use REACH compliant
materials and components.
The foam and cover used to manufacture the Invacare
range of mattresses are independently tested and certified
in accordance with EN 597-1 and EN 597-2 (Assessment of
the ignitability of mattresses and upholstered bed bases -
ignition source: smouldering cigarette (1) and match flame
equivalent (2)).
All products in the range are individually tested as a
composite in accordance with BS 7177 ignition sources 0, 1
and crib 5, both top and bottom tests comply.
For further information contact your Invacare representative.
See addresses at the end of this manual.

1.5 Intended use

This pressure redistribution mattress is intended to be used
in conjunction with an appropriately sized bed frame, as
part of an overall pressure ulcer prevention program of care.
Any other use is prohibited.
This product has been designed to deliver effective pressure
redistribution to users, when the product is in normal use
1587276-C
which is defined by Invacare as when the support surface
is covered with a cotton, cotton combination or linen
bed sheet, and any one of these would be the only item
deployed between the support surface and the user.

1.6 Service life

We estimate a life expectancy of five years for these
products, provided they are used in strict accordance
with the intended use as set out in this document and
all maintenance and service requirements are met. The
estimated life expectancy can be exceeded if the product
is carefully used and properly maintained, and provided
technical and scientific advances do not result in technical
limitations. The life expectancy can also be considerably
reduced by extreme or incorrect usage.
The fact that we estimate a life expectancy for these
products does not constitute an additional warranty.
General
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