User Manual; Product Overview - Invacare Flo-Tech Xtra Benutzerhandbuch

Flo-tech® Xtra Accessories
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.
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.
In case of a serious incident with the product, you should
inform the manufacturer and the competent authority in
your country.
1.2 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.
This product features the UKCA mark, in compliance with
Part II UK MDR 2002 (as amended) Class I.
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.
1.3 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.
1.4 Limitation of Liability
Invacare accepts no liability for damage arising from:
• Non-compliance with the user manual
• 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
2
IenI

2 Product Overview

2.1 Product Description
A
Pelvic obliquity pad
A
Clinical fluid sac
B
Fluid pack
C
Side wedges
D
Lateral wedges
E
Front wedge
F
Deep pommel
G
Standard pommel
H
Thigh aligner
I
Hip aligner
J
2.2 Intended Use
These accessories are intended to be used in conjunction
with a compatible cushion to meet the specific positioning
needs of the end user. Cannot be used on their own.
Intended users
Flo-tech accessories can be used for users who need pelvic
stability and are at very high risk of developing pressure
ulcers.
Indications / contra-indications
There are no contra-indications known.
3 Accessories / Options
3.1 Installing accessories
All the parts are installed using the hook and loop strips.
ALWAYS remove the clinical fluid sac B before fitting
the accessories.
Installing Fluid pack
B
1486370-C