General; Device Description - Etac Alto Mode D'emploi

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.
The images which are referred to on each page are found
at the start of the manual (pages 3 to 13). See Figures A
to F for the corresponding text.

Device description

Alto (hereafter also referred to as "the device" or "the product"),
is an assistant propelled shower commode chair with a battery-
powered seat raise-and-tilt.
Intended purpose
Alto is a medical device intended for alleviation of or compensa-
tion 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 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 8 years. For complete information
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 assistance with
transfers to/from the chair.
Contraindications:
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.
Ignoring the instructions for use may result in injury.
A defective device must not be used. Risk of injury.
The device must not be modified. Risk of injury.
Check user sensitiveness for pressure ulcer before use.
Body parts may get pinched while applying or removing the
pan.
A heated device can cause burns.
The hand control must not be used by persons with cogni-
tive impairment.
Keep children away from the device. Risk of strangulation
due to cables.
Keep children away from the device. Risk of squeezing due
to moving parts.
Risk of squeezing due to moving parts.
Do not use accessories or parts not described in the
instructions for use. Risk of 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 ISO
17966, IEC 60601-1 and IEC 60601-1-2.
Pre-purchase information
Pre-purchase information can be found at www.etac.com.
Instructions for replacement of parts
When installing accessories and spare parts, the assembly
instructions must be followed. Assembly instructions can be
found at www.etac.com
Contact information
For questions regarding use, maintanance or problems, contact
your local dealer.
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.
Device description
1. Frame lower part.
2. Leg support with foot plate and heel strap.
3. Seat unit.
4. Arm support.
5. Back support upholstery.
6. Item no label (serial.no., date of manufacture).
7. Label electrical information.
19
Etac / Alto / www.etac.com
See Figure A