Publicité
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
12). See Figures A to F for the corresponding text.
Device description
The Swift Mobil-2 family is a range of mobile shower
commode chairs whereof Swift Mobil-2 and Swift Mobil
Tilt-2 are assistant propelled and Swift Mobil 24"-2 can
be propelled by the user. The devices can be adapted to
specific user´s needs through several adjustments and
accessories.
Intended purpose
Swift Mobil-2, Swift Mobil-2 XL, Swift Mobil 24"-2, Swift
Mobil Tilt-2 and Swift Mobil Tilt-2 XL (hereafter also
referred to as "the device" or "the product"), are medical
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. They are 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
environments 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 10 years. For complete
information regarding the service life of the device,
see www.etac.com.
= Accessories
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 assistance with transfers to/from the chair.
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.
Make sure the castors are locked when the user
sits down or gets up from the chair. Risk of injury.
A defective device must not be used. Risk of
injury.
Check user sensitiveness for pressure ulcer before
use
A heated device can cause burns
Body parts may get pinched while applying or remo-
ving the pan.
Ignoring the instructions for use 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 and ISO 17699:2016.
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 must 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.
17
Etac / Swift Mobil-2 / www.etac.com
en
Publicité
