Interacoustics TRV chair, Instructions For Use Manual

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D-0125111-A – 2020/04
TRV chair – Instructions for Use - EN Page 14
Even though all the materials are skin-friendly, it is recommended to use
normal clothing covering arms, legs and feet during the examination. There
might be a minimal risk of skin reactions with bare skin in contact with the
safety harness, pads or straps.
Potential side effects:
•
Patients presenting with moderate headache may experience a worsened condition after the
treatment.
• Patients presenting with nausea may be at risk of vomiting during the diagnostic and therapeutic
maneuvers. They must be requested to alert the operator as early as possible if they are about to
vomit so the operator can terminate the procedure, put the patient in the upright position, remove
the goggles and open the harness and leg strap. A container must be kept available to collect any
vomit.
Connection to other medical devices:
• The TRV chair is constructed for use with the IEE1394a FireWire™ Video Frenzel or VNG
systems from Interacoustics A/S. Eye images are recorded by means of infra-red video cameras
mounted on the goggles. A cable connection with two sets of slip-rings conducts the video signal
from the cameras, through the two axles, to a computer. The eye images are analyzed and
displayed on an external screen for optimal observation of nystagmus during the diagnostic and
therapeutic procedures.
Precautions to be taken in the event of changes in the performance of the device:
•
The manufacturer should be advised of any change in the performance of the device. The device
should be taken out of use and not returned to use until the necessary corrective actions, as
specified by the manufacturer, have been carried out.
WARNING