Standards And Regulations; Intended Use; Service Life - Invacare Softform Premier Active 2 User Manual

If a defect or fault is discovered the Invacare® customer or Local
Business 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 defective 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.

1.4 Standards and regulations

Quality is fundamental to the company's operation, working within
the disciplines of ISO 9001 and ISO 13485.
All Invacare® Softform® 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 comply with the current environmental legislation (e.g.
WEEE and RoHS directives).
•
We only use REACH compliant materials and components.
The foam and cover used to manufacture the Invacare® Softform®
range of mattresses are independently tested and certified in
accordance with EN 597-1, EN 597-2 and BS 7177 Crib 5.
The control unit is tested to EC Directive 2004/108/EEC and EN
55011. Manufactured to comply with EN 60601-1.
For further information please contact Invacare® in your country
(addresses see back page of this manual).
1576248-C

1.5 Intended use

This pressure redistribution mattress and control unit are intended
to be used in conjunction with an appropriately sized bed frame, as
part of an overall pressure ulcer prevention program of care.
It can be used safely in static mode (deflated) for static pressure
redistribution, or in dynamic mode (inflated) should an alternating
pressure support surface be required. *
Any other use is prohibited.
This product has been designed to deliver effective pressure
reduction to users, when the product is in normal use which is
defined by Invacare 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.
* Operator action is required to change settings only.

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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