Service Manual
2
INDICATION FOR USE
The REAL
Immersive System is an immersive virtual reality and display system that
interactively displays and tracks upper-extremity rehabilitation exercises for adult pa-
tients using a combination of virtual environments and full presence tracked avatars
for visual feedback. These rehabilitation exercises are intended to be conducted in a
seated position in a clinical environment and prescribed and supervised by a medical
professional trained in rehabilitation therapy.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
If a patient experiences motion sickness, dizziness, headache, eye strain, or fatigue
when using the device, stop use of device immediately.
Use caution when using this device if a patient has a history of vestibular issues or
motion sickness.
PRECAUTIONS
Ensure a safe environment for the patient while performing activities with the device
(e.g. remove any surrounding obstacles to prevent injury). As this device is to be
used for upper body rehabilitation, the patient must remain seated to avoid a fall.
Be aware of the patient’s limitations in range of motion and avoid device or program
use that could lead to excessive gestures that could injure a patient.
Extended use of the headset can cause discomfort or eye strain.
Incorrect placement of the sensors on the patient may result in the avatar appearing
incorrectly or distorted on the headset and tablet.
Device should not be dropped. Device is not intended for continued use if dropped
from higher than 1 meter (3 feet). Damage (mechanical and electrical) may result if
the tablet, headset, sensors, router, router battery, and/or sensor charger are dropped
or struck against another object.
Do not touch the router and patient at the same time. Patients using the device
should not be allowed to touch the router at any time.
During use and while charging, the surface of the equipment will not exceed 41°C.
Sensors will transmit inaccurate position data if used near metal including, but not
limited to, wheelchairs, walkers, and utility carts.
Headset tracking may be lost or compromised if close or low-contrast objects or
surfaces obscure the tracking cameras on the front of the headset.
To avoid risk of electric shock, this equipment must only be connected to a supply
mains with protective earth.
At no time should liquid products be allowed near any device component.
No modification of this equipment is allowed.
Use of accessories, transducers, and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
Portable RF communications equipment (including peripherals such as antenna cables
and external antennas) should be used no closer than 30 centimeters (12 inches) to any
part of the REAL Immersive System, including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
Accessories such as power adapters and cords should not be replaced by the end
user and should only be replaced by the manufacturer. Any changes or replacements
of accessories could impact FCC compliance of REAL Immersive System.
Use of this device should be in a secure information technology environment.
Outbound https communication channels must be open.
POTENTIAL ADVERSE EFFECTS/EVENTS
Visual stimulation through head-mounted displays have a small possibility of provok-
ing an epileptic seizure. Should this occur, stop using the device immediately.
Other possible complications include, but are not limited to, the following:
•
discomfort or pain in the head or eyes
•
dizziness
•
drowsiness
•
eye strain
•
headache
•
light-headedness
•
migraine
•
motion sickness
•
nausea
•
pain
•
vertigo
•
vision problems
Should any of the above occur, stop using the device immediately.