Intended Use; Product Description; Service Life - Invacare Softform Premier Active 2 Manual Del Usuario

General
If a defect or fault is discovered the Invacare
Development Manager from whom the appliance was obtained must be
notified immediately.
The manufacturer will not accept responsibility for damage caused by
misuse or non-observance of the instructions set out in this user guide.
During the period of the warranty any products that have become de-
fective due to faulty workmanship or materials will be renewed without
charge.
The warranty will be forfeited should any unauthorized alteration be
made to the equipment.
Both warranty and fire retardancy Certification will become null and
void if non-Invacare spares are used on any Invacare
®
Mattress products.
The purchaser's statutory rights under the Consumer Protection Act
are not affected.
Quality and Flame Retardancy
Quality is fundamental to the company's operation, working within the
disciplines of ISO 9001 and ISO 13485.
The Softform Premier Active 2
®
compliance with the Medical Device Directive.
The foam and covers used to manufacture the Invacare
ge of mattresses are independently tested and certified in accordance
with EN 597-1 and EN 597-2 and BS 7177 Crib 5.
The pump unit is tested to EC Directive 89/336/EEC, EN 55022 and
EN 61001-1, 2. Manufactured to comply with EN 60601-1.
For further information please contact Invacare in your country
(addresses see back page of this manual).

1.5 Intended use

This pressure redistribution mattress and pump is intended to be used
in conjunction with an appropriately sized bed frame, as part of an
overall pressure ulcer prevention program of care.
dealer or Local Business
®
Softform
®
Mattress features the CE mark, in
Softform
®
It can be used safely in static mode (deflated) for static pressure redis-
tribution, or in dynamic mode (inflated) should an alternating pressure
support surface be required.
This product has been designed to deliver effective pressure reduction
to users, when the product is in normal use which is defined by Inva-
care Ltd 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 Product Description

The Softform ® Premier
sure reducing support/mattress for patients at high risk that can, by
facilitating the air pump, introduce effective alternating pressure if the
®
patients condition requires alternating pressure therapy.
The water-resistant cover provides a vapour-permeable, multi stretch
surface, to promote patient comfort and to maximise the effectiveness
of the foam core.
The complete system comprises of:
A mattress insert comprised of alternate air cells that connect to a
twin air connector hose.
A Micro-processor controlled air pump unit.
A 5 meter power lead.
ran-
®

1.7 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 care-
fully 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.
Softform ® Premier Active 2 Mattresses
Active 2 mattress system acts as a static pres-
5