Etac Clean Manual Del Usuario página 14

Etac / Clean / www.etac.com
General
Thank you for choosing an Etac product. In order to avoid
damage during assembly, handling and use, it is important
to read this manual and save it for future reference. You
can also find it at
www.etac.com. You can select your language via the
"International" and "Local websites" link. Here you will
also find other product documentation, such as prescriber
information, pre purchase guide, and reconditioning
instructions.
In the manual, the user is the person sitting in the chair.
The carer is the person helping the user.
Item list: = Applies to,
See the item list on the right which displays the information
applicable to each product.
The images which are referred to on each page are
found at the start of the manual (pages 3 to 9). See
Figures A to F for the corresponding text.
Device description
The Clean family is a range of mobile shower commode
chairs whereof Clean and Clean Height adjustable are
assistant propelled and Clean 24" can be propelled by the
user.
Intended purpose
Clean, Clean 24" and Clean Height adjustable (hereafter
also referred to as "the device" or "the product"), are medi-
cal devices intended for alleviation of or compensation for
a functional impairment due to an injury or disability. The
device is designed to be used when performing hygiene
tasks in the shower, at a sink, or over the toilet, as well as
for transfers to and from the hygiene room.
Intended user group
The user group for the device is based on the individual's
functional ability and not on a specific diagnosis, health
condition or age. It is intended for individuals with a height
of 146 cm or more, or a mass of 40 kg or more.
Secondary users of the device are caregivers providing
assistance and clinicians/technicians who set up the
device.
Intended environment
The device is intended for indoor use at home environ-
ments or institutions and is suitable for use in bathrooms,
but not swimming pools or similar corrosive environments.
Intended application
The device is intended for short-term and long-term use
and can be applied several times per day.
The device is intended for use with intact skin. The device
is intended for refurbishment and reuse.
Expected service life
The expected service life is 7 years. For complete infor-
mation regarding the service life of the device, see
www.etac.com.
Indications
Indication for use is disability, including, but not limited to,
an individual with physical disabilities who needs backrest
and/or armrests to maintain a sitting position and assis-
tance with transfers to/from the chair.
= Accessories
Contra indications:
There are no known contraindications.
Warnings
Warnings describing a risk element for a specific action or
setting of the device can be found in the relevant section.
Check user sensitiveness for pressure ulcer before
use
A defective device must not be used.
Heated device can cause burns
Body parts may get squeezed while applying or remov-
ing the pan
Ignoring installation or assembly instructions may
result in injury.
Declaration of conformity
The device meets the requirements of the Medical Device
Regulation (EU) 2017/745.
The device is tested and meets the requirements of
the EN ISO 10993-1, SS EN 12182.
Pre-purchase information
Pre-purchase information can be found at www.etac.com.
Adverse event
In case of an adverse event occurred in relation to use of
the device, it should be reported to your local dealer and
the national competent authority in a timely manner. The
local dealer will forward information to the manufacturer.
Customization
is everything that goes beyond the manual's instructions
and settings. Device specially adapted by the customer
must not retain Etac's CE marking. Etac's warranty expires.
If there is any uncertainty regarding the execution of the
customization, consult Etac. Device coupled with another
device may not retain either device's CE mark unless
combination agreements exist. Contact Etac for current
information.
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