Safety
The TD Pilot device has been tested and approved as compliant to all the Specifications and Standards listed in Compliance Information of this manual and in the Technical Specifications -- including, but not limited to, the Medical Device Standard (Class 1/Type B). Nevertheless, in order to ensure safe operation of your TD Pilot device, there are a few safety warnings to bear in mind:
Any serious incident that has occurred in relation to the TD Pilot should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established
No modification of this equipment is allowed.
Repairs to a Tobii Dynavox device must only be performed by Tobii Dynavox or a Tobii Dynavox authorized and approved repair center.
Contraindication: The TD Pilot device should never be, for the user, the only means of communicating important information.
In case of failure of the TD Pilot device, the user cannot communicate using it.
The TD Pilot 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 TD Pilot device.
The TD Pilot device shall not be exposed to or used in weather conditions outside the Technical Specification of the TD Pilot device.
The TD Pilot device shall only be used with TD Pilot 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 TD Pilot device without parental or guardian supervision.
In case the TD Pilot device malfunctions or an ESD event, restart the device.
Do not attach any decorations, stickers, papers, or similar on the screen side of the TD Pilot device. These may interfere with the Eye tracking or touch screen performance.
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.
Avoiding 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 damage 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 TD Pilot device can produce sounds in decibel ranges that may cause hearing loss for a normal hearing person, even when exposed to for less than a minute. The maximum sound level of the unit is in parity with the sound levels that a healthy young person can produce while screaming. Since the TD Pilot 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 when needed in noisy environments.
Power Supply and Batteries
The TD Pilot device uses lithium-ion batteries. These batteries have a storage temperature range of between -20 °C/-4 °F and 40 °C/104 °F within 3 months.
Move the TD Pilot 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 °C/122 °F. 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 TDBW1 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 TD Pilot device, use only the chargers, batteries and accessories approved by Tobii Dynavox.
Do not open (except for the battery cover), or modify, the casing of the TD Pilot device or of the power supply, since you may be exposed to potentially hazardous electrical voltage. The device contains no serviceable parts. If the TD Pilot device or its accessories are mechanically damaged, do not to use them.
If the battery is not charged or the TD Pilot is not connected to the power supply, the TD Pilot 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 TD Pilot device. Furthermore, all configurations shall comply with the system standard IEC 60601-1. 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. The unit is for exclusive interconnection with IEC 60601-1 certified equipment in the patient environment and IEC 60601-1 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 TD Pilot device so that it is difficult to operate the disconnection device.
Special regulations apply to shipping Lithium-ion batteries. If dropped, crushed, punctured, thrown, abused 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.org/whatwedo/cargo/dgr/Pages/lithium-batteries.aspx
Do not leave batteries uncharged for long periods to avoid deep discharge.
The TD Pilot should only be used with the NGE60-TD power supply.
Mounting
The TD Pilot should be mounted according to the instructions of the approved mounts used. Tobii Dynavox or its agents are not liable for damage or injuries to a person or its property due to a TD Pilot falling from a mounted configuration. The mounting of a TD Pilot is done entirely at the user’s own risk.
Emergency
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.
Infrared
The TD Pilot emits pulsed infrared (IR) light from the eye tracker. Other devices controlled by IR or susceptible to disturbance by IR light might be affected by the IR light emitted from the TD Pilot. Do not use the TD Pilot in the vicinity of such devices if their functionality is of critical importance.
Epilepsy
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.
Electricity
Do not open the casing, except for the battery cover, of the TD Pilot device, since you may be exposed to potentially hazardous electrical voltage. The device contains no user serviceable parts.
Software
Software other than that which is pre-installed on the TD Pilot is installed at the user's own risk. External software could cause the TD Pilot to malfunction and might not be covered by the warranty.
Child Safety
The TD Pilot is an advanced computer system and electronic device. As such it is 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.
Eye Tracking
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 tracking. If you are experiencing fatigue or dry eyes start off slowly and limit the length of your Eye tracking sessions to your comfort level. Remoisturizing eye drops can be helpful to combat dryness.
Third Party
Tobii Dynavox assumes no responsibility for any consequence resulting from use of the TD Pilot in a manner inconsistent with its intended use, including any use of the TD Pilot with third-party software and/or hardware that changes the intended use.