Version V2C22021 Vesticam™ User Manual Page | 3
1.Introduction
This user manual is valid for Vesticam2 IR video googles, monocular (V2C22021) and binocular (V2C2C22021)
Manufactured by:
Vesticam Pty Ltd
ABN: 22 625 062 295 (registered for GST)
p: 1300 141 488
f: 02 6638 9618
e: info@vesticam.com
w: www.vesticam.com
Registered office: 29 Endeavour Drive, Bellingen NSW 2454
1.1 Intended Use
Vesticam IR video goggles are intended for use by qualified health care professionals/ medical specialists/
trained clinicians working with patients who have various degrees of dizziness or vertigo (vestibular conditions), and
for research and education purposes. The standard and accepted assessment of vestibular conditions involves
general history taking, a thorough and detailed vestibular specific subjective assessment, testing for differential
diagnoses, and the clinician’s choice of over 15 standard and clinically proven bedside tests. Some of these tests are
performed in complete darkness or require patient head movement, making the rapid and often fleeting eye
movements even more difficult to observe clearly.
Vesticam IR video goggles are an active medical device intended by the manufacturer to be used for the
specific purpose of improving observation of eye movement during some of the currently accepted and used 15
clinical bedside tests. The user/clinician remains entirely responsible for their choice of specific bedside tests, any
clinical interpretation of the eye movement, and any further subjective or objective assessment. The intended
outcome of providing eye movement recordings is that the user/ clinician can more confidently support their own
clinical judgement with regard to the need for more detailed assessment.
Vesticam IR video goggles are not intended by their manufacturer to replace the clinical judgement of a
health professional in relation to making a clinical diagnosis or decision about the treatment of patients. Vesticam IR
video goggles do not have a measuring function and are not intended by the manufacturer to measure quantitatively
a physiological or anatomical parameter.
Vesticam IR video goggles are powered by connection to the clinician’s recording device: android phone,
tablet or computer. Any of these devices can allow viewing and recording using the clinician’s or organization’s own
software. Clinicians must follow their own, or their organization’s normal Electronic Medical Record pathways in the
recording, storage and transfer of eye movement videos taken using Vesticam IR video goggles.
1.2 Product Description
(a) System Configuration