Real Y Series User manual

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REAL y-Series™
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 Effects/Events 4
Operating Profile 5
Operating Procedure 5
• Section 1: Getting Started and Charging Components 5
• Section 2: Internet Connectivity (Online Configurations Only) 6
• Section 3: Start-Up System for Patient Use 6
• Section 4: Managing a Therapeutic or Wellness Session 8
• Section 5: System Removal 10
• Section 6: Software Description 10
Technical Specifications 24
Symbol Glossary 24
Technical Information 24

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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 y-Series™ is a digital hardware and software medical device platform
utilizing virtual reality technology designed for use in healthcare and focusing on
physical, neurorehabilitation and/or wellness needs.
REAL y-Series consists of following components:
∙ All-In-One Headset (HMD) with Software Experiences
∙ HMD Controller
∙ Large Sensor
∙ Small Sensors
∙ Sensor Charger (charging station)
∙ Tablet
∙ Router
∙ Router Battery
∙ REAL Sensor Bands
Frequently used features and functions:
Headset (HMD)
∙ The headset provides visual feedback of virtual reality experiences in concert
with the REAL y-Series tablet and large and small sensors.
∙ Plug headset power cord into headset to charge device, ensure y-Series
power cord is plugged into wall outlet.
∙ Press power button to turn on/off headset. The power button is located on
top of the headset.
∙ Press the volume buttons to adjust volume. The volume buttons are located
on the left side of the headset.
HMD Controller
∙ Headset controller is to only be used for troubleshooting or administrative
tasks. It is not used during patient therapy.
∙ The controller is used to access headset settings or control volume.
Large Sensor and Small 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.
∙ Components are removed or placed back into the sensor charger (charging
station) to activate or charge device.
∙ Components are placed into the sensor bands.
Sensor Charger
∙ The sensor charger charges the sensors. Ensure y-Series power cord is
plugged into wall outlet.
Tablet
∙ Tablet is fitted with a touch screen that allows the user to:
- Launch REAL TherapyView™ application on the tablet
- Log in
- Add or select patient
- Select a therapy experience or activity
- Initialize and sync to sensors
- Select, start, modify, or end therapy session
- View data
- Log out
∙ Plug tablet power cord into tablet to charge device, ensure y-Series power
cord is plugged into wall outlet.
∙ Press power button to power on/off tablet. The power button is on the edge
of the device.
Router and Router Battery
∙ Router allows the REAL y-Series components to communicate with each
other
∙ Router battery provides power to the router when system is not connected to
wall outlet.
∙ Online Configurations Only: Router connects the REAL y-Series to internet
Sensor Bands
∙ Place or remove sensor bands on or from patient.
At full charge, the entire system can last a minimum of 60 minutes and it is
recommended that a therapy session does not exceed 60 minutes. Please sufficiently
charge all components between each session for a minimum of 60 minutes.
In the event of electromagnetic disturbances, the performance of the REAL y-Series
may be affected.
The REAL y-Series is a Type BF Applied Part.
There is no preventive inspection, calibration, or maintenance necessary for the
REAL y-Series besides the initial set up procedure. During the three-year product
lifespan of the REAL y-Series, the device will continue to perform safely without
any routine maintenance. No parts within the REAL y-Series will require inspection
nor maintenance by a service personnel to ensure basic safety during the three-
year product lifespan. Circuit diagrams and calibration instructions are not provided
because service or parts repair is not necessary.
Contact the local REAL representative or Penumbra if the system no longer
stays powered on and connected through the entire recommended duration of a
therapy session.

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REAL Sensor Bands are recommended for one hundred uses or until the sensor
bands no longer hold the sensors or its orientation.
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 sufficiently low enough so that movement can be quickly detected.
INDICATION FOR USE
The REAL y-Series is an immersive virtual reality and display system that interactively
displays and tracks rehabilitation exercises using a combination of virtual
environments and full presence tracked avatars for visual feedback.
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
(i.e. remove any surrounding obstacles and ensure that the patient is unlikely to trip or
fall). Ensure a medical professional is with the patient at all times to prevent any injury.
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.
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.
Sensors will transmit inaccurate position data if used near metal including, but not
limited to, wheelchairs, walkers, utility carts, smartwatches and mobile devices.
Headset tracking can be lost or compromised if the front facing camera sensors on
the headset are obstructed or facing highly reflective surfaces.
Third conductor of the AC cord is a functional earth. 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, external antennas, smart watches, and mobiles devices) should be used
no closer than 30 cm (12 inches) to any part of the REAL y-Series, 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 y-Series.
Use of system with online configurations should be in a secure information
technology environment. Https communication channels must be open.
POTENTIAL ADVERSE EFFECTS/EVENTS
Visual stimulation through head-mounted displays has 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
∙ skin irritation
Should any of the above occur, stop using the device immediately.

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OPERATOR PROFILE
Operators of the REAL y-Series should be trained in rehabilitation therapy. Follow
facility guidelines for use and access to account login credentials (if applicable). For
systems with online configurations, the same account login credentials shall not be
used by more than one REAL y-Series 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 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 the course of
therapy.
OPERATING PROCEDURE
SECTION 1: GETTING STARTED AND CHARGING COMPONENTS
1. Remove REAL y-Series case from the shipping container and inspect for
damaged or missing components.
2. Connect the REAL y-Series 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:
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
4. Ensure the headset is connected to its power cord (USB-C cord). LED light on
top of headset will show blinking red, blinking green or solid green to indicate
charging status.
Large Sensors
Tablet
All-in-One Headset (HMD)
Small Sensors
Sensor Charger
Power Cord

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5. Ensure the tablet is connected to its power cord (USB-C cord).
SECTION 2: INTERNET CONNECTIVITY (Online Configurations Only)
Note: Prior to first time use, the REAL y-Series must be configured and connected to
the local internet. To continue using the REAL y-Series over its lifespan, user may be
prompted/required to complete over-the-air software updates.
Connecting to Wi-Fi
1. Turn on tablet by pressing and holding down power button for approximately
5 seconds.
2. Launch the TherapyView application if it is not already open.
3. Press “OK” on the REAL Service prompt.
4. On the log in page, click on the “Network Setup” button in the bottom right
corner.
5. Connect using the desired wireless network name and password.
6. Press the button at the top left of the screen to return to the TherapyView
application home screen.
See Get Connected Guide section in the REAL y-series Quick Start Guide for more
detailed instructions. Continue to Section 3 when 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 and sufficiently
charged.
2. If tablet is not turned on, turn on.
3. Turn on headset by pressing and holding power button for approximately 5
seconds.
4. Place headset on patient’s head in the sequence numbered below. Patient can
immediately begin visually interacting with the environment.
1
2
3
4
Note: Size of headset strap and interpupillary distance can be adjusted for fit. Top of
head pad may be removed temporarily for better fit on larger heads.
Note: Patient can keep eyeglasses on.

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5. Confirm audio can be heard but does not block out the patient’s ability to
communicate; adjust volume on headset as needed.
Hold 5 seconds
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.
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 fit, if necessary.
Front View Back View
10. Launch the TherapyView application if it is not already open.
11. Log in and select an existing patient or add new patient. Edit patient
information and avatar settings to match your patient as needed.
Online Configurations Only: Patient information and avatar settings will be
saved to the patient’s profile for subsequent sessions.
12. Once a patient is selected or created, initiate the session by pressing “Start
Session.”

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SECTION 4: MANAGING A THERAPEUTIC OR WELLNESS SESSION
1. Select a therapy or wellness experience and press “Run Experience”.
2. Have the patient sit in a neutral position away from metal components, facing
forward with hands on thighs. Press the button on the tablet screen to calibrate
the sensors.
3. Confirm patient’s avatar in VR space corresponds to patient’s physical
movement. If the avatar looks correct, press “Continue”. If not, recalibrate the
sensors by selecting “Remap Sensors”.
4. Press “Start” to begin an activity. You may also use the Activity Menu to
select a new activity or return to the Experience Selector to switch to other
experiences.
(See Section 6 for more details about therapeutic and wellness experiences).

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5. Always remain with the patient throughout therapy session to provide direct
supervision.
6. Monitor patient view on tablet; select and begin new experiences or activities
as desired.
Note: After 20 minutes of inactivity in TherapyView, the user will be automatically
logged out of the TherapyView application. To start a new session, exit out of
TherapyView completely and return to step 10 in Section 3.
Note: If sensors lose synchronization or headset loses tracking, reset the entire
system. Headset should be turned off and on using the power button. TherapyView
application should be relaunched on the tablet. Sensors should be reset by placing
them in the powered charging station (while the REAL y-Series is plugged in) and
then removing them.
7. When planned therapy activities are complete, press “End” on tablet.
8. View patient results on tablet. You may also switch to the Notes tab for a
summary of session and activity times.
Online Configurations Only: Patient information will be saved to the patient’s
profile for subsequent sessions.

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Section 5: SYSTEM REMOVAL
1. Remove sensors and bands.
2. Remove headset from patient’s head.
3. Power off headset by pressing and holding onto the power button for
approximately 5 seconds.
4. Log out of the TherapyView application.
5. Clean headset and sensors with institutional approved sanitizing wipes* as
needed.
6. Ensure REAL y-Series Case is plugged in.
7. Connect tablet and headset to their respective power cords. Red or green LEDs
should be noted on the headset.
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. Sufficiently charge all components after each use and prior to next use for a
minimum of 60 minutes.
Note: Standard operation is to power cycle and relaunch the system between therapy
sessions to re-establish system connections.
*Handle the lenses on the headset carefully to avoid smears or scratches. Wipe
lenses with a soft cloth for cleaning. 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 water-based solvents for cleaning. UV light can be used to clean plastic
components of sensors but should be avoided for the headset. Neoprene side of
sensor bands can be wiped down using an institutional approved sanitizing wipe.
REAL y-Series Case Instructions:
REAL y-Series 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. If reset is necessary, set the dials to
the previous set combination and repeat steps 2 to 4 above.
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.
Section 6: SOFTWARE DESCRIPTION
REAL y-Series contains a variety of experiences with a multitude of activities that
incorporate clinically recognized, existing therapeutic, functional, and wellness
exercises to facilitate motor learning, cognitive function, memory, and relaxation.
Settings for each experience and their activities will involve parameters such as
turning on and off avatar features and environmental factors. While using the
REAL y-Series, 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.