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+1-215-667-8990
1.1. CONTACT INFORMATION
This manual is valid for the Insight Infrared Video Goggles.
The manufacturer Vestibular First is located at:
9 Mather Ave
Broomall, PA, 19008
United States
They can be contacted at:
Online:
VestibularFirst.com/support
Email :
Phone:
+1-215-667-8990
The country of origin is the United States of America
1.2. INDICATIONS OF USE
The Insight Infrared Video Goggles are intended for viewing and recording eye
movements in support of identifying vestibular disorders in patients. The device
is intended for use only by a trained healthcare professional in an appropriate
healthcare setting. This device provides no diagnoses nor does it provide
diagnostic recommendations. The target population is 12+ years of age.
1.3. PRODUCT DESCRIPTION
The system consists of a head-mounted goggles made up of modular units including
a body unit, removable front cover (camera unit), two infrared video cameras inside
the camera unit, cable with two USB connectors, and an off-the-shelf (OTS) video
viewing software application running on a clinician-supplied computer. The Insight
Infrared Video goggles are designed to be used by clinicians to visualize and record
eye movements with and without fixation. These goggles can be used wherever a
clinician may need to examine a patient, including but not limited to hospitals, rehab
facilities, outpatient clinics, urgent care centers, and patients’ home environments.
1. Introduction