Invacare® Softform®
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1 General
1.1 Introduction
This user manual contains important information about the
handling of the product. To ensure safety when using the
product, read the user manual carefully and follow the safety
instructions.
Note that there may be sections in this document, which are
not relevant to your product, since this document applies
to all available models (on the date of printing). If not
otherwise stated, each section in this document refers to all
models of the product.
The models and configurations available in your country can
be found in the country-specific sales documents.
Invacare reserves the right to alter product specifications
without further notice.
Before reading this document, make sure you have the latest
version. You find the latest version as a PDF on the Invacare
website.
If you find that the font size in the printed document is
difficult to read, you can download the PDF version from the
website. The PDF can then be scaled on screen to a font size
that is more comfortable for you.
For more information about the product, for example product
safety notices and product recalls, contact your Invacare
distributor. See addresses at the end of this document.
In case of a serious incident with the product, you should
inform the manufacturer and the competent authority in
your country.
1.2 Symbols in this Document
Symbols and signal words are used in this document and
apply to hazards or unsafe practices which could result in
personal injury or property damage. See the information
below for definitions of the signal words.
WARNING
Indicates a hazardous situation that could result
in serious injury or death if it is not avoided.
CAUTION
Indicates a hazardous situation that could result
in minor or slight injury if it is not avoided.
IMPORTANT
Indicates a hazardous situation that could result
in damage to property if it is not avoided.
Tips and Recommendations
Gives useful tips, recommendations and
information for efficient, trouble-free use.
1.3 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 Regulation 2017/745 Class I. The launch date
of this product is stated in the CE declaration of conformity.
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 Warranty Information
We provide a manufacturer’s warranty for the product
in accordance with our General Terms and Conditions of
Business in the respective countries.
Warranty claims can only be made through the provider from
whom the product was obtained.
1.5 Limitation of Liability
Invacare accepts no liability for damage arising from:
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Non-compliance with the user manual
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Incorrect use
•
Natural wear and tear
•
Incorrect assembly or set-up by the purchaser or a third
party
•
Technical modifications
•
Unauthorised modifications and/or use of unsuitable
spare parts
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.
2 Safety
2.1 Safety Information
Education, clinical judgement and action-based planning
based on vulnerability are fundamental factors in prevention
of pressure injuries.
A range of assessment scales can be used as a formal method
of assessing risk from pressure injury development, and
should be used in conjunction with an informal assessment
(informed nursing judgement). Informal assessment is
considered to be of greater importance and clinical value.
WARNING!
Risk of Serious Injury or Damage
Improper use of this product may cause injury
or damage.
– If you are unable to understand the warnings,
cautions or instructions, contact a health care
professional or provider before attempting to
use this equipment.
– Do not use this product or any available
optional equipment without first completely
reading and understanding these instructions
and any additional instructional material such
as user manual, service manual or instruction
sheet supplied with this product or optional
equipment.
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