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3  Warnings and Precautions

The T.O.V.A. provides objective measures of attention and inhibitory control. The T.O.V.A. does not diagnose any disease or disorder or make a recommendation of treatment. T.O.V.A. performance should always be considered in the context of all available clinical information and should only be interpreted by a qualified professional.

WARNING: Repetitive flashing of display may cause eye strain, headaches, or seizures. Please seek medical help if you experience any eye strain, headaches, or seizures.

The T.O.V.A. microswitch is a Type B Applied Part, i.e., a part of the System meant to be handled by the subject. The T.O.V.A. USB device and associated cables are not applied parts, and are not meant to be handled by the subject.

The T.O.V.A. can only be connected via the USB connector: Only connect the USB input to equipment that is certified to UL 60950-1 and IEC 60950-1.

The T.O.V.A. microswitch should be cleaned in between subjects. See section 9 for directions.

The T.O.V.A. is designed to be stored, operated and transported in a standard indoor environment: a temperature of 10 to 40 C (50 to 104 F), 0 to 100% relative humidity, and an atmospheric pressure of 64.4 to 106.6 kPa.

T.O.V.A. results should be interpreted only by qualified professionals.

Do not interrupt the T.O.V.A. test while it’s being administered. Selecting ‘Esc’ will result in the test being interrupted.

Do not open the T.O.V.A. hardware enclosures; there are no user serviceable parts inside the T.O.V.A. hardware.

Do not unplug the T.O.V.A. hardware when in use (during a test). This will result in lost session data.

Always make sure that your PC is plugged into a power outlet during Session mode. A low battery during a test session may cause the test data to be lost.

Caution: If a new display or new PC is used, the display must be recalibrated prior to administration of the T.O.V.A. test.

The T.O.V.A. Precision Test Environment does not support the use of multiple monitors/screens.

The T.O.V.A. does not support network share databases. Storing data on a server or network share will most likely result in lost data. Please only use the T.O.V.A. with a local database.

We always recommend that you back up your T.O.V.A. database before installing or uninstalling the T.O.V.A. . Automatic local database backups are built into the T.O.V.A. application and enabled by default, but we recommend that you also regularly back up your database (and the rest of your PC) to a secure location.

Warning: The surface of the T.O.V.A. microswitch may become hot (41 C / 106 F) during use. Discontinue use if holding the switch becomes uncomfortable.

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.

This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical 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 other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, 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:


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