D-0126440-A – 2020/08
VisualEyes™ 515/525 Instructions for Use - US Page 7
1.6 Safety features and complaints handling
1.6.1 Complaints/safety reporting:
Please contact your local distributor in case of any incident related to product defects (hardware
defects or software bugs) or adverse events (which does not necessarily have a causal association
to the product). It is recommended for a user to report all the known facts about the incident. Upon
receipt of any serious incident with serious health impact for the patient or user (serious adverse
events), Interacoustics shall ensure that the regulatory authority in patient’s home country is
informed according to the vigilance requirements. Interacoustics shall handle all the product complaints and
adverse events as per the internal procedure.
1.6.2 Safety features of the product
The VisualEyes™ system provides various safety features to ensure patient safety and various error messages
as check points for the better performance of tests especially with all rotational chair options. Refer to section 4.8
for details on the error messages. Other safety features are described below.
1.6.3 All types of rotational chairs
All types of rotational chairs (Orion Reclining/Auto Traverse/Comprehensive, System 2000 Reclining/Auto
Traverse/Comprehensive and Nydiag 200) have an emergency stop button which resides at the operator’s
station and the operator can manually override the system to stop the chair, laser, and OKN drum by pressing
the button. Rotating the emergency stop button will release the devices and the system is ready for operation.
The operator can restart the test from the software.
Rotational chair has seat belt to secure the patient from falling during the tests. Rotational chair tests do not
respond to the RF remote as an additional patient safety measure. Refer to additional information guide for more
details.
1.6.4 Orion and System 2000 reclining chairs
The VisualEyes™ system does not allow a rotational chair to spin at the reclining position and the operator
immediately gets an alert message from the software.
1.6.5 Orion Auto Traverse/Comprehensive chairs
The Orion Auto Traverse/Comprehensive chairs come with a booth enclosure. The booth enclosure is wired to
ensure that the booth door is closed before testing. If the door is open, the test will not start. If you open the door
during testing, the test will be stopped, and the operator gets an alert message.
Note: the chair, laser and drum are disabled for any test when the booth remains open.
The patient-controlled stop button is secured on the right side of the head support of the Orion
Auto Traverse/Comprehensive chairs. The patient can press the stop button during testing. Pressing the button
during a test will stop the chair, laser and OKN drum.
The chair has a built-in watchdog timer that checks if the software and chair are communicating. If there is no
communication, the watchdog timer will stop the chair, laser and OKN drum. Following, the operator shall exit
the test or go to home screen and restarting the test will reset the watchdog timer (refer to section 4.8.9 to know
more). If the fault repeats, the operator shall address the issue before proceeding with the test.
1.6.6 N
ydiag 200 reclining chair
The patient-controlled stop button is located underneath the right armrest. Pressing the button during a test will
cause the chair to stop.
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