Etac Cross 5 - Miscellaneous

3
Etac / Cross 5 / www.etac.com
1. General
Explanation for list of points
Applies to model
Standard for this model
Cross 5 XL
Cross 5
Cross 5 Cross 5 XL
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 nd it at www.
etac.com. You can select your language via the “International” and
“Local websites” link. Here you will also nd other product docu-
mentation, such as prescriber information, pre purchase guide, and
reconditioning instructions.
In this manual the user is the person sitting in the chair. The
caregiver is the person helping the user.
To avoid damage or injury during handling and use, this
manual should always accompany the device.
Device description
Cross 5 and Cross 5XL (hereafter also referred to as ”the device” or
”the product”) are manual wheelchairs with cross-folded frames. They
are adaptive and congurable through adjustable settings, options
and accessories.
Intended purpose
Cross 5 and Cross 5XL are assistive devices intended for the allevi-
ation of or compensation for a physical impairment due to an injury or
disability. The device is designed for mobility. The device is designed
for hand and/or foot propulsion and/or to be pushed and steered by
an assistant.
Intended user group
The user group for the device is based on the individual’s functional
ability and not on a specic diagnosis, health condition or age. The
device 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 attendants providing assistance
and clinicians/technicians who set up the device.
Intended environment
The device is intended for indoor and outdoor use on levelled
ground and accessible terrain. It is not to be exposed to salt water.
The device has xation points for transport in motor vehicle.
Intended application
The device is intended for short-term and long-term use. The device
is intended to be used with a seat cushion. The device is intended
for use with intact skin only. The device is intended for refurbish and
reuse.
Expected service life
The expected service life of the device is 10 years. Preventive main-
taince is recommended. Lack of maintenance may reduce the expec-
ted service life of the device. For full information on the expected
service life, see www.etac.com.
Indications
Indication for use is disability, including, but not limited to, an
impaired ability to ambulate.
Contraindications
There are no known contraindications.
Warnings
Warnings describing a risk element for a specic action or setting
of the device can be found in the relevant section.
Risk of burns and blisters! Device temperature can
increase when exposed to direct sunlight.
Tipping risk! Always check the anti-tips function after
adjusting seat height and angle, centre of balance,
back support angles, height and upholstery, and/or
added accessories that can affect the balance of the
chair.
This device can be adjusted beyond safe use! Adjust-
ments should only be carried out by a person who
understands the use of the device.
CE marking, tests
The device conforms with MDR (EU) 2017/745.
The device is tested and conforms with EN 12183 (which includes
re testing according to ISO 8191-2) and ISO 7176-19.
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
Actions outside the instructions and settings in the manual will
invalidate the CE marking according to MDR 2017/745 and void the
warranty.
Combinations
Risk-managed combinations between Etac devices and devices
from other suppliers are presented in the combination list on
www.etac.com.
Miscellaneous
Etac regularly improves its products. We therefore reserve the right
to modify the products without prior notice. The dimensions given on
drawings or other material are solely for guidance.
We are not responsible for printing errors or incomplete information.
Tools
Allen key
3, 4, 5, 6 mm
Socket spanner
8, 10, 13, 24 mm
Socket wrench
19 mm
In the centre spread of this manual you will
find a removable section that contains user
information.