User Manual; Standards And Regulations; Intended Use; Service Life - Invacare Matrx Mini Back Manual Del Usuario

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Invacare® Matrx® Mini Back
1.2 Symbols in this user manual
In this User Manual warnings are indicated by symbols. The warning
symbols are accompanied by a heading that indicates the severity of
the danger.
WARNING
Indicates a potentially hazardous situation which if not
avoided could result in death or serious injury.
CAUTION
Indicates a potentially hazardous situation which if not
avoided could result in product damage, minor injury
or both.
IMPORTANT
Indicates a hazardous situation which if not avoided
could result in damage to the product.
Gives useful tips, recommendations and information
for efficient, trouble-free use.
This product complies with the directive 93/42/EEC
for medical products. The launch date for this product
is specified in the CE declaration of conformity.
Manufacturer
1.3 Warranty
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 appliance was obtained.

1.4 Standards and regulations

Quality is of the utmost importance for our company; all processes
are based on the ISO 9001 and ISO 13485 standards.
This product features the CE mark, in compliance with the Medical
Device Directive 93/42/EEC Class 1.
The product meets the requirements of the standards DIN EN 12182
(Technical aids for disabled persons - general requirements and test
methods), DIN EN ISO 14971 (Medical devices - Application of risk
management to medical devices) and DIN EN ISO 10993–1 (Biological
evaluation of medical devices - Part 1: Evaluation and testing within a
risk management system).
Invacare® is 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.
For further information please contact Invacare® in your country (for
addresses, see back page of this manual).

1.5 Intended use

The Matrx® Mini back is designed to be used on a pediatric wheelchair
to maximize seating comfort.
1.6 Scope of delivery (Fig. 1)
The following components are included in the scope of delivery:
Pos.
Designation
A
Mini mounting plates (2x)
B
Cane clamp assembly (2x)
C
Cane plastic inserts Ø 22 mm (2x)
D
Cane plastic inserts Ø 19 mm (2x)
E
Depth/Recline adjustment screws (4x)
F
Cane clamp screws (2)
G
Cane clamp nut plates (2)
4
Pos.
Designation
Long mounting pins (optional)
Tools
Wrench (22 mm) / Allen key (4 mm / 5 mm)

1.7 Service life

The expected service life of this product is three years when used in
accordance with safety instructions and intended use, stated in this
manual. The effective service life can vary according to frequency
and intensity of use.

2 Safety information

WARNING!
– Do not use this product or any available optional
equipment without first completely reading and
understanding the user manual supplied. Invacare®
product manuals are available on your local Invacare
website or at your local dealer. If you are unable
to understand the warnings, cautions or instructions
please contact a health care professional, dealer or
technical personnel before attempting to use this
equipment – otherwise, injury or damage may occur.
WARNING!
Risk of injury
– Invacare® products are specifically designed and
manufactured for use in conjunction with Invacare®
accessories. Accessories designed by other
manufacturers have not been tested by Invacare®
and are not recommended for use with Invacare®
products.
WARNING!
– Skin condition must be checked very frequently after
the installation of any new seating system. Your
therapist and physician should be consulted if you
have any questions regarding individual limitations and
needs. Working with your therapist, physician, and
equipment supplier is the best way to ensure that a
seating choice matches your individual needs. As the
needs of the individual become more complex, the
seating evaluation becomes more important.
WARNING!
Risk of severe injury when transporting the client
within a wheelchair fitted with an Invacare®
Matrx® Mini back in a motor vehicle.
– Wherever practicable Invacare recommends that the
client is transferred out of the wheelchair into a vehicle
seat using a lap and diagonal seat belt or an appropriate
child safety seat.
– Invacare® Matrx® Mini backs may only be used in
conjunction with wheelchairs that comply with the
performance requirements of RESNA WC19 or ISO
7176–19.
– For safe transportation of a client within a wheelchair
in a motor vehicle, refer to the user manuals of the
wheelchair and the tie-down and occupant restraint
system (WTORS).
1625175-A

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