Smartbox G Series Manual page 15

Intended use, user and environment
G10 has been tested as a Class 1 medical
device. Specifications and standards have
been listed in the Compliance section of this
manual.
Please consider these safety warnings to
ensure safe operation of your G10.
Application
Intended Use
• It is used as a voice output communication
aid (VOCA)
• It is used to control a Windows computer
• It is used to operate external devices via
environmental control (EC)
Intended User
It is designed for individuals with complex
communication and/or access needs.
Complex communication and/or access needs
may arise as a result of a variety of conditions
including but not limited to:
• Developmental disorders, e.g. cerebral
palsy, developmental verbal dyspraxia,
autistic spectrum disorder (ASD),
developmental language disorder (DLD),
global delay.
• Acquired disorders, e.g. cardiovascular
accident (CVA/stroke), dementia,
traumatic/acquired brain injury (TBI/ABI)
It may also be used by individuals with complex
access needs in the absence of communication
difficulties for computer control, environmental
control and non-face-to-face communication
e.g. including but not limited to individuals with:
• Spinal cord injury
• Degenerative neuromuscular disease (e.g.
muscular dystrophy, spinal
muscular atrophy)
Intended environment
Although designed to assist with expressive
communication, it should be used in
combination with a range of augmentative and
alternative communication (AAC) methods and
therefore should not be relied on in isolation to
enable an individual to communicate
expressively.
Other methods of AAC may include the use of
paper-based systems, sign language or the use
of eye pointing frames. Despite this, it is
recognised that individuals with signification
communication and/or access difficulties will
rely heavily on a VOCA (in this instance Grid
Pad) to communicate given the significant
enhancement to expressive communication
that a VOCA often brings.
Although designed and manufactured to be
extremely robust and reliable, it is possible to
lose function due to power loss or other
technical issues. For this reason, it should not;
• be used as a life supporting device
• be relied upon for well-being
• be relied upon as the user's only way of
making an emergency call or alarm
• be used to administer medicine.
• be relied upon as the only method of
interaction with EC devices.
It is also not intended to provide information
which is used to takevdecisions with diagnosis
or therapeutic purposes.
When the device is working with other
equipment, there may be interference. For this
reason, G10 should not be used:
• in an MRI environment.
• in an X-ray environment
• in a military environment
• in a harsh RF environment
Accessories
G10 is compatible with a number of accessories
that can be combined together to adjust its
function as a VOCA.
For information on compatible accessories that
are currently available visit:
hub.thinksmartbox.com/topic/us-partner/g-
series/g10
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