General; Introduction; Symbols In This Document; Intended Use - Invacare Medley Ergo Manual Del Usuario

Invacare® Medley® Ergo

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.

1.1.1 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.

1.2 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.
4
• 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.
• 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.

1.2.1 Intended Operator

A healthcare professional or private person who has received
proper training is the intended operator of this product.
The hand control can also be operated by the occupant of
the bed.

1.3 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.

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 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.
We comply with the current environmental legislations WEEE
and RoHS.

1.4.1 Product-specific standards

The product has been tested and conforms to IEC 60601-2-52
(Particular requirements for the basic safety and essential
performance of medical beds) and all related standards.
For further information about local standards and regulations,
contact your local Invacare representative. See addresses
at the end of this document.
1556305-H