Compliance; Product-Specific Standards; Intended Use; Service Life - Invacare Aquatec Ocean Ergo User Manual

Warranty claims can only be made through the provider
from whom the product was obtained.

1.4 Compliance

Quality is fundamental to the company's operation, working
within the disciplines of ISO 13485.
This product features the CE mark, in compliance with the
Medical Device Directive 93/42/EEC Class 1.
We are 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.

1.4.1 Product-specific standards

The product has been tested and conforms to the standard
ISO 17966 (Assistive products for personal hygiene that
support users) and related standards. This includes testing
concerning flammability. Progressive smouldering ignition
and flaming ignition do not occur.
For further information about local standards and
regulations, contact your local Invacare representative. See
addresses at the end of this document.

1.5 Intended use

The shower and toilet commode is designed exclusively as
an aid for showering or bathing, going to the toilet, for use
during personal hygiene (e.g. in front of the basin) or for
transferring patients while indoors. It is intended to be used
by youth and adult patients with or without caregiverˈs
assistance, who have:
1639501-B
• Difficulty standing or keeping their balance
• Weak legs or lower limb disability
• Medical conditions that impair their balance
The product is intended for institutional and private house
hold use. Any other use is prohibited.
WARNING!
Risk of injury
– Never use the product as an aid for getting into
or out of a bathtub, for climbing or descending,
as a support or for similar purposes.
– Do not use the product outdoors.
As a toilet commode, the product can be used over
a standard toilet or independently with the toilet pan
(optional).
The shower and toilet commode may only be used as a
bathing stool in a pool, if the pool does not contain salt
water and an attendant is present at all times.
Temperature for use: 10 - 65 °C

1.6 Service life

The expected service life of this product is five years when
used daily and in accordance with the safety instructions,
maintenance intervals and correct use, stated in this manual.
The effective service life can vary according to frequency
and intensity of use.
General
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