Appendix

Support, Warranty, Training Resources and Trouble-shooting

Customer Support

For support, please contact your local representative or Support at Tobii Dynavox. In order to receive assistance as quickly as possible, make sure you have access to your TD Pilot device and, if possible, an internet connection. You should also be able to supply the serial number of the device, which you find under the Adjustable Stand on the TD Pilot Base.

For further product information and other support resources, please visit the Tobii Dynavox website www.tobiidynavox.com.

Warranty

Please read the Manufacturer’s Warranty paper included in the package.

iPads purchased together with TD Pilot are not covered by this manufacturer's warranty

Tobii Dynavox does not warrant that the Software on the TD Pilot will meet your requirements, that the operation of the software will be uninterrupted or error-free, or that all software errors will be corrected.

Tobii Dynavox does not warrant that the TD Pilot will meet Customer requirements, that the operation of the TD Pilot will be uninterrupted, or that the TD Pilot is free from bugs or other defects. Customer acknowledges that the TD Pilot will not function for all individuals and in all light conditions.

Please read this User’s Manual carefully before using the device. The warranty is only valid if the device is used according to the User’s Manual. Disassembling the TD Pilot Base will void the warranty.

It is recommended to keep the original packaging materials for the TD Pilot.

If the 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.

Training Resources

No specific training is required for the safe and effective use of the primary operating functions of the TD Pilot.

Tobii Dynavox offers a range of training resources for the TD Pilot products and related communication products. You can find them on the Tobii Dynavox website, www.tobiidynavox.com, including Getting Started Guides, webinars and Software Training Cards. The TD Pilot Getting Started Guide and Software Training Cards are delivered with the TD Pilot device.

Trouble-shooting Guide

If the TD Pilot does not Power up

Connect the power supply and wait a couple of minutes to allow charging before trying to power up the device again. If the device does not start up correctly, please contact Customer Support. See Customer Support for contact information.

How do I carry out a Power Reset on the TD Pilot?

Hold down the power button of the device for 10 seconds. Doing so will power off the device regardless of what it was doing. To turn it back on, momentarily press the power button and the device will start up and turn on.

This will not reset the iPadOS device; that must be done as a separate step.

If the device does not start up correctly, please contact Customer Support. See Customer Support for contact information.

How can I tell if the TD Pilot Base is Connected to the iPadOS Device?

In iPadOS go to: Settings > General > About.

If the TD Pilot Base is powered on and properly connected to the iPad you should see Tobii Dynavox Pilot near the bottom.

Refining Eye Gaze

If you are having difficulty using eye gaze with the TD Pilot, this list of common issues and solutions may help you. Try one or more of the solutions, since sometimes a combination results in successfully resolving the problem.

Issue	Solution
Eye tracker does not detect eyes.	Be sure TD Pilot is charged and powered on. Make sure AssistiveTouch is enabled, see Setting up AssistiveTouch. Verify that the cable connecting the TD Pilot device to the iPad is securely plugged in . Check positioning of device and person. Review information on glare from glasses
Accuracy is not good.	Check positioning of device and person, then recalibrate. Review solutions for problems noted below. More than one may apply.
Accuracy gets worse over time.	Recalibrate. Remember to check positioning before doing so. Look away or close eyes for a moment to refocus. Decrease brightness of display: iPad OS Settings > Display & Brightness Increase the text size to make text-based targets larger: iPad OS Settings > Display & Brightness > Text Size See Experiencing eye strain or dryness” below.
Glare from glasses seems to be interfering.	Clean glasses. Limit or eliminate light coming from behind the person using the device. If the user wears multifocal lenses, try repositioning the device to take advantage of the portion of the lens meant for computer use.
Pointer response lags.	Increase Responsiveness setting: TD CoPilot Settings > AssistiveTouch
Difficulty holding dwell for sufficient time.	Shorten dwell time: Assistive Touch: iPad OS Settings > Accessibility > Touch > AssistiveTouch > Dwell Control Seconds TD Talk Keyboard Buttons:TD Talk > Settings > Keyboard TD Talk Non-Keyboard Buttons: TD Talk > Settings > Activation TD Snap Global: Edit > User > Access Method > Selection Type > Dwell Time TD Snap for Specific Buttons: Edit > Select button(s) > Access Method > Dwell Time Turn off Match User settings > Dwell Time Adjusting dwell time in iPadOS Settings affects AssistiveTouch only. Adjusting dwell time in TD Talk or TD Snap affects your communication software only. Increase Movement Tolerance: iPad OS Settings > Accessibility > Touch > AssistiveTouch Decrease Responsiveness setting: TD CoPilot Settings > AssistiveTouch
Selections happen too fast or accidentally.	Lengthen dwell time: Assistive Touch: iPad OS Settings > Accessibility > Touch > AssistiveTouch > Dwell Control Seconds TD Talk Keyboard Buttons: TD Talk > Settings > Keyboard TD Talk Non-Keyboard Buttons: TD Talk > Settings > Activation TD Snap Global: Edit > User > Access Method > Selection Type > Dwell Time TD Snap for Specific Buttons: Edit > Select button(s) > Access Method > Dwell Time >Turn off Match User settings > Dwell Time Adjusting dwell time in iPadOS Settings affects AssistiveTouch only. Adjusting dwell time in TD Talk or TD Snap affects your communication software only. Decrease Movement Tolerance: iPad OS Settings > Accessibility > Touch > AssistiveTouch
Pointer is jumpy or drifts.	Decrease Responsiveness setting: TD CoPilot Settings > AssistiveTouch Remove color from the Pointer: iPad OS Settings > Accessibility > Pointer Control > Color Adjust the size of the Pointer: iPad OS Settings > Accessibility > Pointer Control
Cannot see Pointer.	Modify the size and color of the Pointer to make it stand out: iPad OS Settings > Accessibility > Pointer Control
AssistiveTouch Menu button interferes or distracts.	Move the AssistiveTouch Menu button on the screen. Decrease Idle Opacity of the AssistiveTouch Menu button: iPad OS Settings >Accessibility > Touch > AssistiveTouch
Feeling of motion sickness.	Reduce Brightness of screen: iPad OS Settings >Display & Brightness Remove color from Pointer: iPad OS Settings > Accessibility > Pointer Control Enable Reduce Motion setting: iPad OS Settings > Accessibility > Motion Enable Prefer Cross-Fade Transitions setting: iPad OS Settings > Accessibility > Motion
Experiencing eye strain or dryness.	Take breaks. Reduce Brightness: iPad OS Settings > Display & Brightness Increase text size: iPad OS Settings > Display & Brightness > Text Size Consult physician.
Eyes do not move together (strabismus).	Identify the stronger eye and calibrate with that eye only. Consult physician.
Involuntary eye movements (nystagmus).	Reposition the device to see if there is an area in the visual field in which nystamoid movement decreases.

Compliance Information

The TD Pilot is CE marked in accordance with Regulation (EU) 2017/745 (MDR) and complies with applicable harmonized standards and the General Safety and Performance Requirements (GSPR).

FCC Statement

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference and (2) this device must accept any interference received, including interference that may cause undesired operation.

Modifications not expressly approved by Tobii Dynavox could void the user’s authority to operate the equipment under FCC rules.

For P15B Equipment

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications.

However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.

For Portable Devices

FCC RF Radiation Exposure Statement:

This Transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.
This equipment complies with FCC RF radiation exposure limits set forth for an uncontrolled environment. This device was tested for typical hand held operations with the device contacted directly to the human body to the sides of the device. To maintain compliance with FCC RF exposure compliance requirements, avoid direct contact to the transmitting antenna during transmitting.

CE Statement

This product is CE marked as an accessory to a medical device in accordance with Regulation (EU) 2017/745 (MDR) and conforms to the applicable General Safety and Performance Requirements (GSPR).

Directives and Standards

The TD Pilot complies with the following directives:

Medical Device Regulation (EU) 2017/745
Low voltage Directive 2014/35/EU
Electromagnetic Compatibility (EMC) Directive 2014/30/EU
RoHS2 Directive 2011/65/EU
WEEE Directive 2012/19/EU
Reach Directive 2006/121/EC, 1907/2006/EC Annex 17
ISO 14971:2019
ISO 13485:2016

The TD Pilot device has been tested to comply with IEC/EN 60601-1 Ed 3.1, IEC/EN 62368-1, ISO 14971:2019 and other relevant standards for the intended markets.

Status LED Information

LED Information
State		Meaning
LED	Power Adapter Connected?	TD Pilot Power	TD Pilot Battery	iPad Battery
OFF	NO	OFF	Unknown
OFF	YES		Charged	Unknown
BLUE	(YES)		Charging	Unknown
PULSING BLUE	(YES)	ON	Charging
PULSING GREEN	YES		Charged
PULSING GREEN	NO		Discharging
RED	-	FAULT

Technical Specifications

Device

Model	TD Pilot
Type	TD Pilot
Operating System	Apple iPadOS
CPU	Apple M4 chip (9-core CPU) or newer
Storage	256 GB
Screen Resolution	2752 x 2064
Screen Size	13"
Rear Display	480 × 128 pixels
Dimensions (WxHxD) TD Pilot	30,4 × 25,5 × 9,0 cm 12.0 × 10.0 × 3.5 inches
Weight TD Pilot	2.11 kg 4.65 lbs
Microphone	1×Microphone
Speakers	2 × 10 W Closed Box Speakers
Connectors	1 × Thunderbolt/USB 4 (iPadOS device) 1 × USB-C 2 × 3.5 mm Switch connector interface, (Pin out for mono plug: Sleeve = Common ground, Tip = Signal) 1 × 3.5 mm” Headphone jack (stereo) with jack detection 1×USB-C Power Connector
Buttons	1 × Top button (iPadOS device) 1 × Volume up/down (iPadOS device) 1 × Power On 1 × Track Status
Bluetooth®	Bluetooth 5.3
Eye Tracker (optional)	Tobii IS5TDL Module
Expected Service Life	5 years
Typical Average Battery Run Time	~10 hours
Battery Charge Time	Maximum 4 h
Deskstand	Integrated
Mounting Systems Supported	Tobii Dynavox QR adapter plate for Daessy and REHAdapt
Power Supply	15VDC, 3A, 45 W or 20VDC, 3A, 60 W AC Adapter
IP class	IP54 Pass for device only, with I/O covers in place.
IP class	IP22 Without I/O covers.

Power Adapter

Item	Specification
Trademark	Tobii Dynavox
Manufacturer	MEAN WELL Enterprise Co., Ltd
Model Name	NGE60-TD
Rated Input	100-240Vac, 50/60Hz, 1.5-0.8A
Rated Output	5V/9V/12V/15V/20Vdc, 3A, 60W max
Output Plug	Compatible with USB-C Power Delivery up to 60W

Battery pack

Item	Specification	Remark
Battery Technology	Li-Ion rechargeable battery pack with gas gauge (SMBus v1.1 interface)
Cell	6× NCR18650GA
Battery Pack Capacity	71,28 Wh	Initial capacity, new battery pack
Nominal Voltage	10.8 Vdc, 6600mAh
Charge Time	Maximum 4 h	Charge from 10 to 90%
Cycle Life	300 cycles	Minimum 75% of initial capacity remaining
Allowable Operating Temperature	0 – 45 °C, 45-85%RH	Charge condition
Allowable Operating Temperature	-20 – 60 °C, 45-85%RH	Discharge condition
Storage Temperature	-20 – 35 °C, 45-85%RH	1 year
	-20 – 40 °C, 45-85%RH	6 months
	-20 – 45 °C, 45-85%RH	1 month
	-20 – 50 °C, 45-85%RH	1 week
Storage Time ¹	Maximum 6 months @ charge ≥ 40%	Do not store battery packs for a long time with less than 40% charge level.
It is recommended that the battery shall not be stored in the device if the device is not going to be used within 6 months. If the battery is removed, the battery will not be drained as quickly as when stored in the device.

Eye Tracker

If installed

Technical Specifications	Tobii IS5TDL Module
Working Distance	45 — 95 cm 20 — 37 inches
Freedom of Head Movement ¹ (Width x Height)	˜20 × 20cm (7.9 × 7.9 inches) @ 50 cm from screen ˜35 × 35 cm (13.8 × 13.8 inches) between 65 – 80 cm from screen
Positioning Distance (from screen) Track box size (Width × Height) Track box depth	45 — 95 cm (20 — 37 in) 20 × 20 — 35 × 35 cm (7.9 × 7.9 — 13.8 × 13.8 in) 50 cm (19.7 in)
Gaze Data Rate	33 Hz
Gaze Sample Rate	133 Hz
Eye tracking technique	Video-based pupil- and corneal- reflection eye tracking with dark and bright pupil illumination modes.
Outdoor Usage Possible	Yes
User Calibration (former tracking robustness)	>98%
Detect Gaze Interaction >30Hz	98% for 95% of population²
Gaze Accuracy Across 95% of population³	<1.58 degrees
Gaze Precision Across 95% of population³	<0.2°
Max Head Movement Speed Eye Position Gaze Data	40 cm/s (15.7 in/s) 10 cm/s (3.9 in/s)
Max Head Tilt	25°
Max Yaw, pitch	25°
Data Flow and Data Rate Gaze Latency Gaze Recovery	17 ms 0 ms
Mounting	Built-in
Power Supply	Built-in
Freedom of head movement describes the volume in front of the tracker in which the user must have at least one of the eyes. The numbers are specified parallel/orthogonal to screen surface. The test population excluded those who would wear correctional glasses with a +5.00 diopter or higher or suffer from an eye disease. The degree-of-accuracy and precision over percentage-of-population numbers result from extensive testing across representatives of the whole population. We have made use of hundreds of thousands of diagnostic images and performed tests on approximately 800 individuals with different conditions, vision, ethnicities, everyday dust, smudges or blemishes around their eyes, with eyes out of focus, etc. This has resulted in a much more robust and high-performance eye tracking experience and a much more realistic representation of true performance across the whole population, not just in a mathematically “ideal” scenario. The “ideal” degree numbers are the previous standard of measuring accuracy and precision, both previously from Tobii and presently from all eye tracking competitors. Though “ideal” numbers are useful to get a general feel about comparative quality and performance, they are not applicable to real world usage in the same way as quantitative degree-of-accuracy and precision over percentage-of-population numbers based on extensive testing across representatives of the whole population.

Guidance and Manufacturer’s Declaration

Below cables information are provided for EMC reference

Cable	Max. cable length	Shielded/unshielded	Number	Cable classification
AC Power Cord	0.9 m	Unshielded	1 Set	AC Power
DC Power Cord	1.65 m	Shielded	1 Set	DC Power
Two Switch Button Cables	1.44 m	Shielded	1 Set	Signal
USB cable	0.26 m	Shielded	1 Set	Signal

Important information regarding Electro Magnetic Compatibility (EMC)

This electrical medical equipment needs special precautions regarding EMC and put into service according to the EMC information provided in the user manual; The equipment conforms to this IEC 60601-1-2:2014+A1:2020 standard for both immunity and emissions. Nevertheless, special precautions need to be observed:

The equipment with no ESSENTIAL PERFORMANCE is intended used in Home healthcare environment.
WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally”.
The use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the TD Pilot, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”
WARNING: If the use location is near (e.g. less than 1.5 km from) AM, FM or TV broadcast antennas, before using this equipment, it should be observed to verify that it is operating normally to assure that the equipment remains safe with regard to electromagnetic disturbances throughout the expected service life.

STATEMENT: For the purpose of its operation, the equipment has wireless communication function, it includes RF transmitter and receiver, 2.4 GHz, Pulse modulation.

STATEMENT: The equipment is designed compatible with high frequency surgical equipment; the condition includes working or standby in close proximity to high frequency surgical equipment.

EMI Compliance Table — Emission
Phenomenon	Compliance	Electromagnetic environment
RF emissions	CISPR 11 Group 1, Class B	Home healthcare environment
Harmonic distortion	IEC 61000-3-2 Class A	Home healthcare environment
Voltage fluctuations and flicker	IEC 61000-3-3 Compliance	Home healthcare environment

EMS Compliance Table — Enclosure Port
Phenomenon	Basic EMC standard	Immunity test levels
Phenomenon	Basic EMC standard	Home healthcare environment
Electrostatic Discharge	IEC 61000-4-2	±8 kV contact ±2kV, ±4kV, ±8kV, ±15kV air
Radiated RF EM field	IEC 61000-4-3	10 V/m 80MHz-2.7GHz 80% AM at 1kHz
Proximity fields from RF wireless communications equipment	IEC 61000-4-3	Refer to table
Rated power frequency magnetic fields	IEC 61000-4-8	30A/m 50Hz or 60Hz

EMS Compliance Table — Proximity fields from RF wireless communications equipment
Test frequency (MHz)	Band (MHz)	Immunity test levels
Test frequency (MHz)	Band (MHz)	Home healthcare environment
385	380-390	Pulse modulation 18Hz, 27V/m
450	430-470	FM, ±5kHz deviation, 1kHz sine, 28V/m
710	704-787	Pulse modulation 217Hz, 9V/m
745
780
810	800-960	Pulse modulation 18Hz, 28V/m
870
930
1720	1700-1990	Pulse modulation 217Hz, 28V/m
1845
1970
2450	2400-2570	Pulse modulation 217Hz, 28V/m
5240	5100-5800	Pulse modulation 217Hz, 9V/m
5500
5785

EMS Compliance Table — Input a.c. power Port
Phenomenon	Basic EMC standard	Immunity test levels
Phenomenon	Basic EMC standard	Home healthcare environment
Electrical fast transients/burst	IEC 61000-4-4	±2 kV 100 kHz repetition frequency
Surges Line-to-line	IEC 61000-4-5	±0.5 kV, ±1 kV
Conducted disturbances induced by RF fields	IEC 61000-4-6	3V, 0.15 MHz - 80 MHz 6 V in ISM bands and amateur radio bands between 0.15 MHz and 8 0MHz 80% AM at 1 kHz
Voltage dips	IEC 61000-4-11	0% U_T; 0.5 cycle At 0º, 45º, 90º, 135º, 180º, 225º, 270º and 315º
Voltage dips	IEC 61000-4-11	0% U_T; 1 cycle and 70% U_T; 25/30 cycles Single phase: at 0º
Voltage interruptions	IEC 61000-4-11	0% U_T; 250/300 cycles

EMS Compliance Table — Signal input/output parts Port
Phenomenon	Basic EMC standard	Immunity test levels
Phenomenon	Basic EMC standard	Home healthcare environment
Conducted disturbances induced by RF fields	IEC 61000-4-6	3V, 0.15 MHz - 80 MHz 6 V in ISM bands and amateur radio bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz

Approved Accessories

Description	Model	Tobii Dynavox Part No.
TD Pilot AC Adapter (Power Supply)	NGE60-TD	1000769
Battery pack	TDBW1	13000162
Eye Gaze for TD Pilot	Tobii IS5L Module	520223

For information about the latest approved Tobii Dynavox Accessories, please visit the www.tobiidynavox.com website or contact your local Tobii Dynavox reseller.

Local Certification Partners

The listed companies are the partners for our local certifications in their countries.

Contact Information:

Swiss Authorized Representative
Beratung assistive Technologien
Chamstrasse 33
8934 Knonau
Switzerland

+41 44 597 50 55

SOLUCIONES EN TECNOLOGÍA ADAPTADA MEXICO S.A DE C.V
Av. Rio Mixcoac 164 Col. Acacias Del Valle Deleg
Benito Juarez. CP. 03240
Mexico

+1-800-344-1778