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the prior written permission of the publisher.
Copyright protection claimed includes all forms and matters of copyrightable material and information allowed by
statutory or judicial law or hereafter granted, including without limitation, material generated from the software programs which are displayed on the screen such as screen
displays, menus, etc.
The information contained in this document is proprietary
to Tobii Dynavox. Any reproduction in part or whole without
prior written authorization by Tobii Dynavox is prohibited.
Products that are referred to in this document may be either trademarks and/or registered trademarks of the respective owners. The publisher and the author make no
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While every precaution has been taken in the preparation
of this document, the publisher and the author assume no
responsibility for errors or omissions, or for damages resulting from the use of information contained in this document or from the use of programs and source code that
may accompany it. In no event shall the publisher and the
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Content subject to change without notice.
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www.TobiiDynavox.com for updated versions of this
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Contact Information:
Tobii Dynavox AB
Karlsrovägen 2D
182 53 Danderyd
Sweden
+46 8 663 69 90
Tobii Dynavox LLC
2100 Wharton Street, Suite
400
Pittsburgh, PA 15203
USA
+1-800-344-1778
The following products are protected by U.S. Patents 7,572,008, 6,659,611, 8,185,845 and 9,996,159:
●I–13
●I–16
You can locate the Type of Tobii Dynavox I-Series device on the label on the back side.
Thank you for purchasing a Tobii Dynavox I-Series device from Tobii Dynavox!
To ensure the optimal performance of this product, please take the time to read this manual carefully.
The Tobii Dynavox I-Series device is available in two different sizes: the Tobii Dynavox I–13 with a 13.3" screen and the Tobii Dynavox I–16 with a 15.6" screen. The Tobii Dynavox I-Series is a Eye Gaze device but can be ordered without the Eye
Gaze function.
Dispose of in accordance with your country's requirements
CE is the abbreviation of the European Communities and
this mark tells customs officials in the European Union that
the product complies with one or more of the EC
Directives
This mark is a certification mark employed on electronic
products manufactured or sold in the United States which
certifies that the electromagnetic interference from the device is under limits approved by the Federal Communications Commission
UL Classification Marks for Canada and the United States
Recognized component mark for Canada and the United
States
This mark shows the pin out polarity on the AC/DC Power
Adapter
1 Introduction
7
Symbol or MarkingsDescription
Enclosure ingress protection code per IEC 60529
China Compulsory Certificate
The most recognized International Safety mark. This
safety listing signifies that the product was tested to
IEC60601–1
China RoHS compliance.
RoHS directive compliance.
1.3Intended Use
The Tobii Dynavox I-Series is an Augmentative and Alternative Communication (AAC) product, a purpose-built Speech
Generating Device (SGD) designed to provide to its users increased communication ability and greater independence.
The Tobii Dynavox I-Series is intended primarily to provide, and act as, a compliment to everyday communication for people who have challenges in their ability to speak due to injury, disability or illness. This intended use is reflected in design
features such as long lasting batteries, superior sound quality, high durability, built-in environmental control and alternative
input methods.
The Tobii Dynavox I-Series is a device with an optional Tobii Eye Tracker and a capacitive touch screen for touch access.
The device is intended to be used on a mounting arm, or standing upright on an appropriate surface. In addition to eye
gaze and touch, the device can be operated through switch scanning, mouse, keyboard, or a combination thereof.
The Tobii Dynavox I-Series is designed primarily for face-to-face communication and secondarily for long distance communication, computer access, and environmental control. The Tobii Dynavox I-Series allows the user to communicate via text
or symbols to generate text-to-speech or play back recorded messages for face-to-face communication. The user can also
display their messages on the outwards facing display on the back of the device. The Tobii Dynavox I-Series allows users
to compose text messages (SMS) and e-mails through adapted interfaces or access third party apps and services for online communication, such as Skype or Facebook.
With the Tobii Dynavox I-Series, users have the freedom and flexibility provided via the Microsoft
environment.
The Tobii Dynavox I-Series meets the definition for medical equipment; and is registered as a Class I medical device with
the Swedish Medical Products Agency, and as Class II durable medical equipment with the US FDA. The Tobii Dynavox ISeries is available in two sizes (13.3 and 15.6); and is available as a dedicated (locked) Speech Generating Device. The
Tobii Dynavox I-Series device does not sustain or support life. In case of failure of the Tobii Dynavox I-Series device, the
user should have a low-tech backup solution for communication.
®
Windows 10
Contraindication: The Tobii Dynavox I-Series device should never be, for the user, the only means of communicating important information.
In case of failure of the Tobii Dynavox I-Series device, the user cannot communicate using it.
1.3.1Intended User Profile
The Primary Users of the Tobii Dynavox I-Series I–13 and I–16 are those individuals who, due to physical and/or cognitive
conditions, require an AAC device for Speech and environmental controls. It is appropriate for users of all ages.
A portable Tobii Dynavox I-Series can be used in two (2) different positions.
●Upright orientation
●Mounted (see section 1.3.3 Mounted Use)
Upright Orientation
1.3.3Mounted Use
The mounting plate on the device connects to Connect IT/REHAdapt mounts. If using a Daessy mount, an adapter plate is
needed.
1.4Package Contents
It is recommended to keep the original packaging materials for the Tobii Dynavox I-Series.
If device needs to be returned to Tobii Dynavox for Warranty related issues or repair, it is beneficial that the original packaging or equivalent is used for shipping. Most shipping carriers require at least 2 inches of packing material around the device.
Note: Due to Joint Commission regulations, any shipping materials including boxes sent to Tobii Dynavox must
be discarded.
1.4.1Tobii Dynavox I-Series with Snap Core First / Communicator 5
The items below are included with your Tobii Dynavox I-Series package:
●1 Device (13.3″ or 15.6″)
●1 Adjustable Base
●1 Eye Tracker (built in)
●1 Mounting plate for Connect IT/REHAdapt (mounted)
The Tobii Dynavox I-Series device has been tested and approved as compliant to all the Specifications and Standards
listed in Appendix B Compliance Information, page 47 of this manual and in the Appendix D Technical Specifications, page52 – including, but not limited to, the Medical Device Standard (Class 1/Type B). Nevertheless, in order to ensure safe operation of your Tobii Dynavox I-Series device, there are a few safety warnings to bear in mind:
No modification of this equipment is allowed
Contraindication: The Tobii Dynavox I-Series device should never be, for the user, the only means of communi-
cating important information.
In case of failure of the Tobii Dynavox I-Series device, the user cannot communicate using it.
The Tobii Dynavox I-Series is not to be used as a life supporting device, and it shall not be relied on in case of
loss of function due to power loss or other causes.
There could be a choking hazard risk if small parts detach from the Tobii Dynavox I-Series device.
The Tobii Dynavox I-Series device shall not be exposed to or used in weather conditions outside the Technical
Specification of the Tobii Dynavox I-Series device.
The Tobii Dynavox I-Series device shall only be used with Tobii Dynavox I-Series specific Accessories that have
a mounting instruction included with the accessory.
The charging cable could present strangulation hazards to young children. Never leave small children unattended with the charging cable.
Young children or people with cognitive disabilities should not have access to, or the use of, the Tobii Dynavox ISeries device without parental or guardian supervision.
Do no attach any decorations, post it notes or similar on the screen side of the Tobii Dynavox I-Series device.
These may interfere with the Eye Gaze or touch screen performance.
2.1Avoiding Hearing Damage
Permanent hearing loss may occur if earphones, headphones or speakers are used at high volume. To prevent
this, the volume should be set to a safe level. You can become desensitized over time to high sound levels which
may then sound acceptable yet still could be damaging your hearing. If you experience symptoms such as ringing in your ears, please lower the volume or stop using the earphones/headphones. The louder the volume, the
less time is required before your hearing could be affected.
Hearing experts suggest the following measures to protect your hearing:
●Limit the amount of time you use earphones or headphones at high volume.
●Avoid turning up the volume to block out noisy surroundings.
●Turn the volume down if you cannot hear people speaking near you.
To establish a safe volume level:
●Set your volume control at a low setting.
●Slowly increase the sound until you can hear it comfortably and clearly, without distortion.
The Tobii Dynavox I-Series device can produce sounds in decibel ranges that may cause hearing loss for a normal hearing person, even when exposed for less than a minute. The Maximum sound level of the unit is in parity
with the sound levels that a healthy young man can produce while screaming. Since the Tobii Dynavox I-Series
device is intended as a voice Prosthetic, it shares the same possibilities and potential risks of causing harm to
hearing. The higher decibel ranges are offered to enable communication in a noisy environment and should be
used with care and only in said noisy environments.
When used in direct sunshine or in any other hot environment, the Tobii Dynavox I-Series device may have hot
surfaces. There are built-in temperature sensors that monitors the temperature. If the sensors detects temperatures above the temperature specified in Table E.1 Maximum Allowed Temperature, page 56, the device will au-
tomatically trigger a Windows Shut Down or Hibernate (depending on Windows Power Button configuration) to
prevent risk of harm to the user. It may take a while before the Tobii Dynavox I-Series device can be restarted, as
the unit may need time to cool down.
Do not touch the area specified in Figure E.1 Temperature Threshold Area, page 56 when the Tobii Dynavox ISeries device is running. The specified area can reach temperatures which may cause permanent bodily harm in
the event of prolonged direct skin contact. Use appropriate precautions to avoid injury.
2.3Power Supply and Batteries
The Tobii Dynavox I-Series device uses lithium-ion batteries. These batteries have a storage temperature range
of between -20 ℃/-4 ℉ and 40 ℃/104 ℉ within 3 months.
If you are in a hot environment, be aware that it can affect the ability to charge the batteries. The internal temperature has to be between 0 ℃/32 ℉ and 45 ℃/113 ℉ for the batteries to charge. If the internal battery temperature
raises above 45 ℃/113 ℉ the batteries will not charge at all.
Move the Tobii Dynavox I-Series device and the batteries to a cooler environment to let the batteries charge
properly.
Avoid exposing the batteries to fire or to temperatures above 50 ℃/122 ℉. These conditions may cause a battery
to malfunction, generate heat, ignite or explode. Be aware that it is possible, in a worst case scenario, for temperatures to reach greater than those stated above in, for example, the trunk of a car on a hot day. So, storing the
device, with batteries installed, in a hot car trunk could conceivably lead to a malfunction.
Do not disassemble or harm the battery. Follow the environmental laws and regulations which apply in your area
when disposing of batteries.
The battery may only be replaced by the user with a TDG G1 battery pack sold by Tobii Dynavox. There is a risk
of explosion if the battery is replaced with an incorrect type.
For safe operation of the Tobii Dynavox I-Series device, use only chargers, batteries, and accessories approved
by Tobii Dynavox.
Do not open (except for the battery cover), or modify, the metal casing of the Tobii Dynavox I-Series device or of
the power supply, since you may be exposed to potentially hazardous electrical voltage. The device contains no
serviceable parts. If the Tobii Dynavox I-Series device or its accessories are mechanically damaged, do not touse them.
If the battery is not charged or the Tobii Dynavox I-Series is not powered up by the power supply, the Tobii Dynavox I-Series device will shut down.
If the Power Supply Cord becomes damaged, contact Tobii Dynavox for replacement.
Do not connect any devices with a non-medical grade power supply to any connector on the Tobii Dynavox I-Series device. Furthermore, all configurations shall comply with the system standard IEC 60601-1-1. Anyone who
connects additional equipment to the signal input part or signal output part is configuring a medical system and is
therefore responsible for ensuring that the system complies with the requirements of the system standard IEC
60601-1-1. The unit is for exclusive interconnection with IEC 60601-1 certified equipment in the patient environment and IEC 60XXX certified equipment out-side of the patient environment. If in doubt, consult the technical
services department or your local representative.
The appliance coupler of the power supply or separable plug is used as the Mains Disconnection Device, please
do not position the Tobii Dynavox I-Series device so that it is difficult to operate the disconnection device.
Special regulations apply to shipping Lithium-ion batteries. If dropped, crushed, or short-circuited, these batteries
can release dangerous amounts of heat and may ignite, and are dangerous in fires.
Please reference IATA regulations when shipping lithium metal or lithium-ion batteries or cells: http://www.iata.
The Tobii Dynavox I-Series should be mounted according to MANUFACTURER instructions of approved mounts.
Tobii Dynavox or its agents are not liable for damage or injuries to a person or its property due to a Tobii Dynavox
I-Series falling from a mounted configuration. The mounting of a Tobii Dynavox I-Series is done entirely at the
user’s own risk.
2.5Emergency
Do not rely on the device for emergency calls or banking transactions. We recommend having multiple ways to
communicate in emergency situations. Banking transactions should only be carried out with a system recommended by, and approved according to the standards of your bank.
2.6Infrared
The Tobii Dynavox I-Series emits pulsed infrared (IR) light both from the eye tracker and from the Environmental
Control Unit. Other devices controlled by IR or susceptible to disturbance by IR light might be affected by the IR
light emitted from the Tobii Dynavox I-Series. Do not use the Tobii Dynavox I-Series in the vicinity of such devices
if their functionality is of critical importance.
2.7Epilepsy
Some people with Photosensitive Epilepsy are susceptible to epileptic seizures or loss of consciousness when
exposed to certain flashing lights or light patterns in everyday life. This may happen even if the person has no
medical history of epilepsy or has never had any epileptic seizures.
A person with Photosensitive Epilepsy would also be likely to have problems with TV screens, some arcade
games, and flickering fluorescent bulbs. Such people may have a seizure while watching certain images or patterns on a monitor, or even when exposed to the light sources of an eye tracker. It is estimated that about 3-5%
of people with epilepsy have this type of Photosensitive Epilepsy. Many people with Photosensitive Epilepsy experience an "aura" or feel odd sensations before the seizure occurs. If you feel odd during use, move your eyes
away from the eye tracker.
2.8Electricity
Do not open the casing, except for the battery cover, of the Tobii Dynavox I-Series device, since you may be exposed to potentially hazardous electrical voltage. The device contains no user serviceable parts.
2.9Software
Windows 10 comes with Windows Defender included, providing protection from viruses, malware, and other potential threats. Regardless of whether you use Windows Defender or a third party anti-virus software, we recommend that you always keep your antivirus software up-to-date.
Software other than that which is pre-installed on the Tobii Dynavox I-Series is installed at the user's own risk. External software could cause the Tobii Dynavox I-Series to malfunction and might not be covered by the warranty.
The Tobii Dynavox I-Series are advanced computer systems and electronic devices. As such they are composed
of numerous separate, assembled parts. In the hands of a child these parts have the possibility of being separated from the device, possibly constituting a choking hazard or another danger to the child.
Young children should not have access to, or the use of, the device without parental or guardian supervision.
2.11Environmental Control
The Programmable IR Remote Control — Environmental Control Unit (ECU) is not to be relied on as the only
method of interaction with IR controlled devices.
2.12 Eye Gaze
Some people may experience a certain amount of fatigue (due to intentional eye focusing and hard concentration) or even a dryness of the eyes (due to less frequent blinking) when first getting used to Eye Gaze. If you are
experiencing fatigue or dry eyes start off slowly and limit the length of your Eye Gaze sessions to your comfort
level. Remoisturizing eye drops can be helpful to combat dryness.
2.13 Third Party
Tobii Dynavox assumes no responsibility for any consequence resulting from use of the Tobii Dynavox I-Series in
a manner inconsistent with its intended use, including any use of the Tobii Dynavox I-Series with third-party software and/or hardware that changes the intended use.
The Tobii Dynavox I-Series has several built-in features. Some of these come standard and some can be ordered as additional features.
Standard features: 2 × Camera, 1 × microphone, 2 × speakers, 1 × IR ECU (Environmental Control Unit), 1 × Bluetooth®
and 1 × WLAN (Wireless Local Area Network)
3.2Product Layout
A Tobii Dynavox I-Series device has a color capacitive touch, LED Backlight screen. The Tobii Dynavox I–13 has a 13.3″
screen with a 1920 × 1080 pixel resolution. The Tobii Dynavox I–16 has a 15.6″ screen with a 1920 × 1080 pixel resolution.
3.2.1The Tobii Dynavox I–13 and Tobii Dynavox I–16
Never force a connector into a port. If the connector and port do not join with reasonable ease, they probably do
not match. Make sure that the connector matches the port and that you have positioned the connector correctly
in relation to the port.
Be extra careful with the USB connectors.
3.3Preinstalled Software
The Tobii Dynavox I-Series device is delivered with all pre-ordered and required software installed and ready to use.
Should a reinstallation become necessary at any stage, perform a Factory Recovery. For more information, see 5.11 Resetthe Tobii Dynavox I-Series, page 40.