Appendix B: Compliance Information - Saltillo TouchChat Express 8 Guia Del Usuario

Appendix B: Compliance Information

Electronic Interference Information
This device complies with Part 15 of the FCC Rules. Operation is subject to 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.
Warning! Changes or modifications to this product which are not authorized by PRC-Saltillo could exceed FCC limits and negate your authority
to use this product.
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. You can determine whether
this product is causing interference in your radio or television by turning this product off. If the interference stops, it was probably caused by
this product or one of its accessories. You can attempt to correct the interference by using 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.
•
Canadian Requirements Statement
This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. Cet appareil numérique de
la classe B respect toutes les exigences du Règlement sur le matériel brouiller du Canada.
Wireless Communications Equipment
Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations, and
walkie-talkies can affect this device and should be kept a least six (6) inches away from the device.
Third Parties and Data Loss
PRC-Saltillo assumes no responsibility for any loss or claims by third parties which may arise through the use of this product.
•
PRC-Saltillo assumes no responsibility for any damage or loss caused by the deletion of data as a result of malfunction repairs or
•
battery replacement. Be sure to back up all important data on other media (computer) to protect against its loss.
Connectivity of Peripheral Ports
External equipment intended for connection to signal input, signal output, or other connectors comply with the applicable standards of the IEC
60601 series. In addition, all such combinations—systems—comply with the IEC 60601-1 safety requirements for medical electrical systems. Any
person who connects external equipment to signal input, signal output, or other connectors has formed a system and is therefore responsible for
the system to comply with the requirements of IEC 60601-1. If in doubt, contact a qualified technician or your local representative.
Device Intended Purpose
TouchChat Express is a speech generating device that augments communication for an individual with speech/language impairment. This device
and its language programs give the user the ability to initiate conversation, seek information, state opinions, and share feelings. It can be hand-
held, used with a table stand, or mounted to a wheelchair. It is accessed by using the touchscreen or a variety of available switch accessories.
The device does not incorporate in any way medicinal substances, human blood or plasma derivatives, nor is it manufactured using tissues of
animal origin.
Expected Service Life
The expected service life of the device is five years.
Intended Operators
The individual using the device to communicate, the individual's communication partner, and/or the person changing device settings,
maintaining software files, etc. are the intended operators of the device. The pictures and text in this document will help these operators
achieve the intended use of the device.
Expected Position of Operators
In normal use, the device is expected to be within 12 to 14 inches of the individual's body. The distance will vary according to whether the
device is hand-held or mounted on a wheelchair or table.
Instructions for Use
• All functions of the device are safe for use by the user. For best results, follow the instructions in this manual.
• There is no need to turn the device or amplifier off when using the device on a daily basis. It is recommended to restart the device
once per week and put it to sleep daily.
• To report any serious incident associated with the device, contact PRC-Saltillo and your national authority.
• For information on cleaning the device, see "Cleaning and Disinfecting".
TouchChat Express User's Guide 125