Real IMMERSIVE SYSTEM User manual

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REAL
®IMMERSIVE SYSTEM
USER MANUAL

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Table of Contents
Warning 3
Device Description 3
Indication for Use 4
Contraindications 4
Warnings 4
Precautions 4
Potential Adverse Eects/Events 4
Operating Prole 5
Operating Procedure 5
• Getting Started & Charging Components 5
• Internet Connectivity 6
• Start-Up System for Patient Use 6
• Therapy Activities 8
• System Removal 9
• Software Description 10
Technical Specications 15
Symbol Glossary 15
Technical Information 15

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WARNING! CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL
WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS.
FAILURE TO DO SO MAY RESULT IN COMPLICATIONS.
DEVICE DESCRIPTON
The REAL
®
Immersive System is a digital hardware and software medical device plat-
form using a combination of virtual environments and full presence tracked avatars for
visual feedback. The use of the REAL Immersive System is intended to be in a clinical
environment, supervised by a medical professional trained in rehabilitation therapy.
The REAL Immersive System consists of a clinician tablet, headset (HMD), small sensors,
large sensor, sensor charger, router, router battery, headset controller, power cords, and
USB cables. Note: Bands sold separately.
Tablet is tted with a touch screen, a power/lock key that turns the component on or
o, and a charger/accessory port.
The headset contains a power button that turns the component on or o and a charger/
accessory port. The headset also provides visual feedback of virtual reality applications
in concert with the REAL Immersive System tablet and small and large sensors.
Large and small sensors (WTM and WSMs) are equipped with mechanical and
electrical components that measure motion and direction in physical space and then
translate that information into a virtual environment.
The sensor charger powers the sensors.
Headset controller (Only to be used in certain troubleshooting and administrative
tasks. Not used during patient therapy.)
At full charge, the entire system can last at a minimum of 60 minutes and it is recom-
mended that a therapy session does not exceed 60 minutes. Please suciently charge
all components between use for a minimum of 60 minutes.
In the event of electromagnetic disturbances, the performance of the REAL Immersive
System may be aected.
The REAL Immersive System is a Type B Applied Part.
Frequently used features and functions:
Headset
• Plug headset power cord into wall outlet and headset to charge device.
• Press power button to power on headset or restart headset. The power
button is on top of the headset.
Headset Controller
• Buttons on the controller are used to control power, connect to headset,
access settings, or control volume.
Large Sensor and Small Sensors
• Components are removed or placed back into the sensor charger
(charging station) to activate or charge device.
• Components are placed into the sensor bands.
Tablet
• Plug tablet power cord into wall outlet and tablet to charge device.
• Press power button to power on tablet or restart tablet. The power button is
on the edge of the device.
• User Interface:
- Selecting the application
- Logging in
- Adding or selecting patient
- Initializing and syncing to sensors
- Selecting, starting, modifying, or ending therapy session
- Viewing data
- Logging out
Sensor Charger
• Plug sensor charger power cord into wall outlet and sensor charger to power
on device to charge sensors.
Router/Router Battery
• Power router with router battery.
• Plug router battery power cord into wall outlet and router battery to charge device.
Sensor Bands
• Place or remove sensor bands on or from patient.
There is no preventive inspection, calibration, and maintenance necessary for the
REAL Immersive System besides the initial set up procedure. During the one-year
product lifespan of the REAL Immersive System, the system will continue to perform
safely without any routine maintenance. No parts within the REAL Immersive System
will require inspection nor maintenance by a service personnel to ensure basic safety
during the one-year product lifespan. Circuit diagrams and calibration instructions
are not provided because service or parts repair is not necessary.
At the end of the one-year product lifespan, the user should contact the local REAL
representative or Penumbra if the following event occurs:
• The system no longer stays powered on and connected through the entire
recommended duration of a therapy session.
Supply mains are electrically isolated in medical equipment to maintain basic safety.
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 suciently low enough so that movement can be quickly detected.

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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
patients 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 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, router,
router battery, 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.
Do not touch the router and patient at the same time. Patients are not allowed to
touch the router at any time.
During use, 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, utility carts, smart watches, and mobile devices.
Headset tracking can be lost or compromised if large objects obscure 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 modication of this equipment is allowed.
Use of accessories, transducers, and cables other than those specied 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 ca-
bles and external antennas, smart watches, and mobile devices) should be used no
closer than 30 cm (12 inches) to any part of the REAL Immersive System, including
cables specied 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. Out-
bound 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:
• 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
Should any of the above occur, stop using the device immediately.

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OPERATOR PROFILE
Operators of the REAL
®
Immersive System should be trained in rehabilitation therapy.
Follow hospital guidelines for use and access to account login credentials. The same account
login credentials shall not be used by more than one REAL System at any given time.
Note: These rehabilitation exercises are intended to be conducted in a clinical environment
and prescribed and supervised by a medical professional trained in rehabilitation therapy.
Rehabilitation therapy treatment and technique decisions will vary based on the clinical
judgement of the treating medical professional. A medical professional must be present at
all times to provide direct supervision throughout course of therapy.
OPERATING PROCEDURE
Note: Prior to rst time use, router must be congured and connected to the local internet.
Note: Over-the-air software updates may occur throughout the lifespan of the REAL System.
User may be prompted/required to complete software updates to continue using the product.
Note: These rehabilitation exercises are intended to be conducted in a seated position.
The patient must be seated at all times when the system is in use.
SECTION 1: GETTING STARTED AND CHARGING COMPONENTS
1. Remove REAL Immersive System case from the shipping container.
2. Connect the REAL Immersive System
case to its power cord (AC adapter
power cord). Plug the power cord into
a grounded electrical outlet, making
sure that it is the same voltage as
indicated on the unit nameplate.
Ensure the power receptacle is
connected to a supply mains with
protective earth.
3. Ensure sensors with white sides facing forward are in their corresponding size
slots on the sensor charger. LED lights on sensors will show the following:
4. Ensure the headset is connected to its power cord (USB-C cord). LED lights
on top of headset will only show blinking green or solid green to indicate
charging status.
5. Ensure the tablet is connected to its power cord (USB-C cord).
Solid Green: Full battery
LED Off: Battery dead or sensor asleep
Solid Blue: Connected
Blinking Red: Low battery, charging
Blinking Green: Charging
Blinking Blue: Connecting

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SECTION 2: INTERNET CONNECTIVITY
1. Turn on tablet by pressing power button for approximately 5 seconds.
(May take up to 30 seconds if tablet was fully drained of battery).
2. Launch TherapyView™ if it is not already open.
3. On the log in page, click on the “Network Setup” button.
4. Enter the username and password below to login into the router:
a. Username: realadmin
b. Password: realsystem
5. Connect using the desired wireless network name and password.
a. To connect using a network name and password:
i. Select “Wireless 5 GHz” from the menu. If the desired
network is a not a 5 GHz network, select “Wireless 2.4 GHz”.
Wireless 5 GHz is preferred to Wireless 2.4 GHz.
ii. Select “Scan” to search for local networks.
iii. Select “Connect” next to the desired network.
iv. Enter the password into the corresponding eld.
v. Select “Save”.
vi. The REAL Immersive System should now be connected.
6. Click the button at the top left of the screen to return to the TherapyView
home screen.
Continue to Section 3 when the components are suciently charged, and the system
has secure internet connectivity.
SECTION 3: START-UP SYSTEM FOR PATIENT USE
1. Unplug power cords from tablet and headset when ready to use.
2. If tablet is not turned on, turn on.
3. Turn on headset by pressing and holding power button for
approximately 5 seconds.
4. Ensure the patient is in a seated position away from metal components and
remains seated at all times for the duration of the therapy session.
5. Place headset on patient’s head in the sequence numbered below. Patient
can immediately begin visually interacting with the environment.
Note: Size of headset strap and interpupillary distance can be adjusted for t. Top of
head pad may be removed temporarily for better t on larger heads.
Note: Patient can keep eyeglasses on.
6. Remove sensor bands from reusable packaging (sold separately). Each
patient should have their own sensor bands and bands should not be shared
between patients.
7. Remove all sensors from sensor charger.
Hold 5 seconds
1
2
3
4

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8. Place small sensors onto bands by sliding them into elasticized loops. For
the hand sensor bands, tighten elasticized loop using the buckle. Place large
sensor into pocket of shoulder band.
9. Once sensors are placed in the bands, put each band onto its corresponding
body part (see image below). Connect hook and loop fasteners of shoulder
band if desired. Make sure the elbow sensor is sitting behind the patient’s
elbow. Adjust bands for comfortable t, if necessary .
10. Log in to TherapyView on the tablet. Add new patient or select patient from
directory; edit patient information as needed.
Front View Back View
11. Once a patient is selected or created, the healthcare provider (HCP) may
initiate the session by pressing “Start Session.”
12. Have the patient sit in a neutral position, facing forward with hands on knees
or thighs. Press the “Map Sensors” button on the tablet screen to calibrate
the sensors.
13. Patient’s avatar appears immediately after mapping sensors. Edit the default
avatar settings to match the patient. If the avatar looks correct, press “Continue”.
If not, recalibrate the sensors by selecting the “Remap Sensors” button.

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14. The HCP may navigate to additional therapy activities by selecting the corre-
sponding icon from the display. Once the activity is loaded, the HCP can
press the “Start Session” button to begin the activity.
See Section 6 for more information.
Section 4: THERAPY ACTIVITIES
1. Conrm patient’s avatar in VR space corresponds to actual patient’s
physical movement.
2. Conrm application audio can be heard but doesn’t block out HCP’s
communication; adjust volume on headset as needed .
3. Conduct rehabilitation session as planned. (See Section 6 which includes a
software description for details of therapeutic activities).
4. Always remain with the patient throughout therapy session to provide
direct supervision.
5. Monitor patient view on tablet; select and begin new activities as desired.
Note: If sensors lose synchronization or headset loses tracking, turn o entire
system then back on to reset. Headset is turned o and on using the power button.
TherapyView should be relaunched on the tablet. Sensors are turned o and on by
placing them in the powered charging station (while the REAL® Immersive System is
plugged in) and removing them again.
6. When planned therapy activities are complete, press “End Session” on tablet.
Patient will be returned to the Hide and Seek activity.
7. View patient results on tablet. You may also switch to the Notes tab for a
summary of session and activity times.

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Section 5: SYSTEM REMOVAL
1. Remove sensors and bands.
2. Remove headset from patient’s head.
3. Power o headset by pressing and holding onto the power button for
approximately 5 seconds.
4. Log out of TherapyView.
5. Clean headset and sensors with institutional approved sanitizing wipes*.
6. Ensure REAL Immersive System Case is plugged in.
7. Connect tablet and headset to their respective power cords.
8. Return all sensors to sensor charger. Red or green LEDs should be noted on
sensors when placed correctly in the charging station.
9. Store and label bands for future individual patient use.
10. Suciently charge all components after each use and prior to next use
for 60 minutes.
Note: Standard operation is to power cycle and relaunch application between therapy
sessions to reestablish system connections.
*Handle the lenses on the headset carefully to avoid smears or scratches. Wipe
lenses with a soft cloth for cleaning as needed. Clean outer and inner plastic
components of headset with institutional approved sanitizing wipe. Do not use
petroleum-based compounds, acids, caustics, or chlorinated solvents to clean
or lubricate any parts. Use only water-based solvents for cleaning.
REAL®Immersive System Case Instructions:
The REAL Immersive System is housed in a travel case that may be locked with the
attached combination lock that secures the zipper. The combination lock should
be turned to the red dot position at all times. If the combination lock is turned away
from the red dot, turn it to the red dot position.
How to reset the combination lock:
1. Set all combination dials to the following: (0-0-0 default)
2. Find the hole located to the right of the dials. Use a paper clip or similar
tool to press down on the reset button until an audible “click” is heard.
3. Set personal combination by turning the dials to display the desired set of
numbers, e.g. 2-8-7.
4. Push the slide button located on the left of the dials towards the direction
of the arrow and the reset button will push back up. An audible “click” will
be heard.
5. Remember the personal combination and repeat the steps above to
reset the personal combination, if necessary.
How to use the combination lock:
1. To unlock: Turn the dials to the correct combination. Push the slide
button on the left of the dial towards the direction of the arrow to unlock.
2. To lock: Put the loop portion of the zipper into the slots of the lock,
then turn the dials randomly to conceal the personal combination to lock.

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Section 6: SOFTWARE DESCRIPTION
The REAL
®
Immersive System contains a variety of activities that incorporate clinically
recognized, existing therapeutic and functional exercises to facilitate motor and
cognitive rehabilitation as well as activities to support general wellness. Settings for
each activity will involve parameters such as turning on and o avatar features and
environmental factors. While using the REAL Immersive System, the HCP remains
responsible for the patient’s safety and the appropriateness of individual exercises
including range of motion (ROM) attempted and any other limb or joint limitations
unique to that patient.
Hide and Seek
Hide and Seek can be used with or without a displayed avatar tracking the patient’s
upper body as it primarily relies on cervical proprioception and range of motion (ROM).
Hide and Seek puts the patient in a pastoral setting with a number of animated
animals that react to the patient’s acknowledgement of them. Visually scanning the
environment, patients are tasked with nding a small penguin by hovering a blue
gaze pointer on the penguin by turning and rotating their head to exercise their
cervical range of motion. The penguin will then disappear and reappear in a dierent
location. The pointer is positioned to represent the patient’s upper body vertical
midline and is itself a useful tool as some patients in neurorehabilitation have lost
their sense of body position resulting in “midline shift.” The blue pointer provides a
visual, external cue to their true body midline helping them relearn centering themselves.
The Hide and Seek exercise encourages visual scanning of their environment, an
important functional ability, and cognitive recognition of nameable animals, objects,
and environmental locations in their immediate surrounding. This is both the rst
and last experience for the patient. At the end of the patient’s session, the patient can
visualize overall progress they made during the session in the form of virtual “rewards.”
HCPs may adjust various activity parameters through the tablet.
Catch & Glow
Catch & Glow is designed to help the patient exercise cervical proprioception and
ROM. This activity takes place in a low-stimulation, nighttime environment, where the
patient is tasked to focus on and control a small penguin with their head movement
to catch reies that appear in a specic pattern. This activity provides a range of
challenges to help focus on the patient’s gaze stability, oculomotor and visual control,
and postural and cervical control. The HCP can control the complexity of the activity
by adjusting various activity parameters through the tablet.
Hot Air Balloon
Hot Air Balloon is a family of activities designed to help the patient work on core