User's Manual
Table Of Contents
- Table of Contents
- DEVICE DESCRIPTON
- INDICATION FOR USE
- WARNINGS
- PRECAUTIONS
- POTENTIAL ADVERSE EFFECTS/EVENTS
- OPERATOR PROFILE
- OPERATING PROCEDURE
- SECTION 1: GETTING STARTED AND CHARGING COMPONENTS
- SECTION 2: INTERNET CONNECTIVITY
- SECTION 3: START-UP SYSTEM FOR PATIENT USE
- Section 4: THERAPY ACTIVITIES
- Section 5: SYSTEM REMOVAL
- Section 6: SOFTWARE DESCRIPTION
- Therapy Activity 1: Hide and Seek
- Therapy Activity 2: Hot Air Balloon
- Sub-Activity 1: Balloon Pilot
- Sub-Activity 2: Bumper Band
- Sub-Activity 3: Summit Rescue
- Therapy Activity 3: Sunrise
- Sub-Activity 1: Sunrise
- Sub-Activity 2: Harvest
- Sub-Activity 3: Ice Cave
- Therapy Activity 4: Bird Forest
- Sub-Activity 1: Free Birds
- Sub-Activity 2: Nest Hop
- Sub-Activity 3: Bird Match
- Therapy Activity 5: Penguin Sports Park
- Sub-Activity 1: Chuckleball™
- Sub-Activity 2: Chuckleball Arena
- Sub-Activity 3: Flying Fish
- TECHNICAL SPECIFICATIONS TECHNICAL INFORMATION
- SYMBOL GLOSSARY
3 (15)
The full expected latency of the device, including movement detection, processing,
and visual representation is 35 milliseconds or less. This value is considered minimal
and sufficiently low enough so that movement can be quickly detected.
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 or any other facility that may facilitate
rehabilitation and prescribed and supervised by a medical professional trained in
rehabilitation therapy.
CONTRAINDICATIONS
There are no known contraindications.
WARNINGS
If a patient complains of 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 and ensure that the patient is unlikely to trip
or fall). As this device is to be used for upper body rehabilitation, we recommend that
the patient 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.
Damage (mechanical and electrical) may result if the tablet, headset, sensors, and/or
sensor charger are dropped or struck against another object. Device is not intended
for continued use if dropped from higher than 1 meter.
Surface temperature around the headset exhaust may reach 46°C if operating above
nominal room temperature.
3rd conductor of the AC cord is only a functional earth. To avoid risk of electric shock,
this equipment must only be connected to a supply mains with protective earth.
Sensors will transmit inaccurate position data if used near metal including, but not
limited to, wheelchairs, walkers, and utility carts.
Headset tracking can be lost or compromised if large objects obscure the headset.
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 cm (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 Penumbra. Any changes or replacements of
accessories will likely impact compliance of REAL Immersive System.
Use of this device should be in a secure information technology environment.
Outbound https communication channels must be open.
AC power cord must not exceed 6 feet in length.
POTENTIAL ADVERSE EFFECTS/EVENTS
Visual stimulation through head-mounted displays have a small possibility of
provoking an epileptic seizure. Should this occur, stop using the device immediately.
Other possible complications include, but are not limited to, the following:
• claustrophobia
• discomfort or pain in the head or eyes
• disorientation/vertigo/dizziness
• drowsiness
• eye strain
• falls or fractures
• headache/migraine
• insomnia
• light-headedness
• motion sickness
• nausea• pain
• seizure
• repetitive strain injury
• vision problems