General; Introduction; Symbols In This Manual; Intended Use - Invacare Sonata User Manual

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Invacare® Sonata

1 General

1.1 Introduction

This user manual contains important information about the
handling of the product. In order to ensure safety when
using the product, read the user manual carefully and follow
the safety instructions.
To ensure correct use, the bed must be tested and adjusted
by qualified personnel.
All references to left and right are based on a person lying
on his back in the bed, with his head in the head end.
If a problem should arise in connection with the delivered
product, please contact your Invacare® dealer. An address
list is shown on the back side at this manual.

1.1.1 Symbols in this manual

Symbols and signal words are used in this manual 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.
This product complies with Directive 93/42/EEC
concerning medical devices. The launch date
of this product is stated in the CE declaration
of conformity.
Manufacturer of the product.

1.2 Intended Use

The bed has been developed for domestic care and long
term care:
Application environment 3; Long-term care in a
medical area where medical supervision is required
and monitoring is provided if necessary and medical
electrical equipment used in medical procedures may
be provided to help maintain or improve the condition
of the patient.
Application environment 4; Care provided in a domestic
area where medical electrical equipment is used to
alleviate or compensate for an injury, disability or
disease.
The bed is intended for indoor use only.
The bed is intended for adult users, having a physical
size equal to or more than 146 cm, a weight equal to
or more than 40 kg and a body mass index (BMI) equal
to or more than 17.
4
The bed is not intended for transportation of users. It
is mobile within a room with a user in it. Castors are
lockable.
The bed is not intended for psychiatric patients.
Maximum user weight and safe working load are listed
on the product label and in the technical data section
in this manual.
WARNING!
Any other or incorrect use could lead to hazardous
situations.
Invacare accepts no liability for any use, change
or assembly of the product, other than stated in
this user manual.

1.3 Service life

The expected service life of this product is seven 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.

1.4 Compliance

Quality is fundamental to the company's operation, working
within the disciplines of ISO 13485.
We are continuously working towards ensuring that the
company's impact on the environment, locally and globally,
is reduced to a minimum. We use only REACH and RoHS
compliant materials and components.
The product is compliant with the European Directive
93/42/EEC concerning Class 1 medical devices.
The product has been tested and conforms to IEC 60601-2-52
– Medical Beds and all related standards. This includes tests
regarding flammability and biocompatibility.

1.5 Warranty

The warranty covers all material and production defects
for two years from the date of delivery, provided it can
be demonstrated that such defects were present before
delivery. All manufacturing faults or defects must be
promptly reported.
Invacare® may repair the fault or replace the component.
The warranty provided by Invacare® does not cover
additional costs (transport, packaging, labour, sundry
expenses, etc. are for the customer's account).
The warranty does not cover:
Damage caused during transport that is not directly
reported to the forwarder at the moment of delivery.
Repairs performed by unauthorized centers and
personnel.
Parts subject to normal wear.
Malicious damages or damaged caused by improper
use of the bed.

1.6 Limitation of liability

Invacare accepts no liability for damage arising from:
Non-compliance with the user manual
Incorrect use
Natural wear and tear
1574228-E

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