REAL® SYSTEM 2 User Manual Table of Contents Abbreviations?? Warning Device Description Indication for use Contraindications Warnings Precautions Potential Adverse Effects/Events Operating Profile Operating Procedure • Getting Started & Charging Components • Internet Connectivity • Start-Up System for Patient Use • Therapy Activities • System Removal • Software Description Technical Specifications Symbol Glossary Technical Information Troubleshooting Guide 3 3 4 4 4 4 4 5 5 5 6 6 8 9 10 13 13 13 WARNING
• • • • • • All-In-One Headset with Software Application Headset Controller Large Sensor Small Sensors Sensor Charger (charging station) REAL Sensor Bands The headset contains a power button that turns the component on or off and a charger/accessory port. The headset also provides visual feedback of virtual reality applications in concert with the REAL System 2 small and large sensors.
• Large Sensor and Small Sensors Activate or charge sensor devices by removing or placing back into the sensor charging station. • Place sensor devices into the sensor bands. Sensor Bands • See Section 3 in Operating Procedures on instructions to put on sensor bands.
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 System 2 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.
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.
OPERATING PROCEDURE Note: These rehabilitation exercises are intended to be conducted in a seated position. Be seated at all times when the system is in use. SECTION 1: GETTING STARTED AND CHARGING COMPONENTS 1. Remove REAL System 2 components from the product box. 2. Connect sensor charger base to its power cable supplied in the Accessories box. The wire will go through the grommet hole supplied in the box. Plug into a wall outlet.
3. Connect the headset to its power cord supplied in the Accessories box and plug into a wall outlet. LED lights on top of headset will show either blinking green or solid green to indicate charging status.
1. Unplug power cords from headset when ready for use. 2. Turn on headset by pressing and holding power button for approximately 2 seconds. 3. Turn on the headset controller by pressing the small circular button. The controller will vibrate once it has been turned on. Note: If the headset controller does not vibrate, press and hold both the headset controller’s small circular button and the headset’s Volume Down button – the singular dot on the left underside of the headset.
. Once connected, the headset will display your home Wi-Fi at the top of the WLAN list and the status will read ‘Connected’. 10. To exit, power off the headset before starting a session. 11. Ensure patient’s personal device such as computer, tablet or smartphone is connected to desired Wi-Fi 12. Reset password to log into patient portal using the login information provided in the welcome email HCP: 1.
4. Once sensors are placed in the bands, put each band onto its corresponding body part (see image below). Connect hook and loop fasteners of the torso band if desired. Adjust bands for comfortable fit, if necessary. 5. Be in a seated position away from metal components and remain seated at all times for the duration of the therapy session. Initiate the session by pressing “Start Session”. Put on the headset per in the sequence numbered below and begin visually interacting with the environment. 6. 7.
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: Eyeglasses may be worn during device use. 8. Sit in a neutral position, farcing forward with hands on knees or thighs. Press the button on the screen to calibrate the sensors. After the sensors are calibrated, begin the activity.
HCP: Patient Rehabilitation Activities: 1. Log into the HCP Portal and locate the patient profile. 2. Select the designated activity and click “Start Session”. Patient Wellness Activities: 1. Log into the HCP Portal and locate the patient profile. 2. Review patient’s session results. See Section 4 and 6 for more information. Section 4: ACTIVITY NAVIGATION User 1. Conduct rehabilitation session as planned. (See Section 6 which includes a software description for details of therapeutic activities).
Note: If sensors lose synchronization or headset loses tracking, turn off entire system then back on to reset. Headset is turned off and on using the power button. App should be relaunched on the tablet. Sensors are turned off and on by placing them in the powered charging station (while the REAL System 2 is plugged in) and then removing them again. 5. When planned therapy activities are complete, press “End session”. Patient will be returned to the Hide and Seek activity. 6. View patient results.
3. Power off headset by pressing and holding onto the power button for approximately 2 seconds. 4. Clean headset and sensors with institutional approved sanitizing wipes*. 5. Connect headset to the power cord. 6. Ensure REAL System 2 sensor charger is plugged in. 7. Return all sensors to sensor charger. Red or green LEDs should be noted on sensors when placed correctly in the charging station. 8. Store and label bands for future use. 9.
Hide and Seek can be used with or without a displayed avatar tracking the patient’s upper body as it primarily relies on head movement and visual scanning ability. 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. This is both the first 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.
Hot Air Balloon is an introductory activity to help the patient work on core control and strength as well as centering and postural proprioception. By leaning their torso from a sitting position in a certain direction, and holding it there against gravity, they fly a hot air balloon in that same direction. There are a number of objectives the patient can achieve by flying the balloon around.
Therapy Activity 3: Sunrise This activity is based on simple shoulder flexion. The patient holds their arms out straight in front of them and raises their arms up and over their head in a motion that ideally, is pure shoulder flexion with a maximum, healthy ROM of 180 degrees. This exercise may be done passively with HCP assistance or actively by the patient themselves. This exercise encourages postural alignment and symmetrical seated shoulder flexion.
The Harvest sub-activity involves growing a variety of vegetables by raising and lowering one’s arms a number of times in order to trigger the appearance of day-night cycles. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patient’s rehabilitation plan.
The patient should use their hand(s) to pick up a bird and move it to a colored target nest in a specific order under time pressure. This sub-activity will exercise both the patient’s functional and cognitive ability. When a target nest has been filled, a new target nest will appear, and the patient will have to move the bird from the previous nest to the new target. Sub-Activity 3: Bird Match A bird will need to be picked up and matched to the corresponding colored nest.
environment can also serve as targets. The HCP can control how fast the ball travels towards the patient, the distance the patient must reach to block the ball, and the number of balls to be kicked at the patients. Sub-Activity 3: Flying Fish Flying fish is similar to Chuckleball where the patient must deflect a fish being pitched at them with their head or hands. This may elicit a defensive response movement from the patient in VR.
SYMBOL GLOSSARY Refer to User Guide (Instruction manual) Type BF Applied Part WEEE Manufacturer Catalog Number Lot Number Date of Manufacture Both Direct and Alternating Current Class II Equipment Serial Number US and Canada Certification Medical Device Keep Dry Protection against ingress of solid foreign objects level 2 and water level 1 Protection against ingress of solid foreign objects level 2 and water level 2 TECHNICAL INFORMATION REALTM System 2 is intended for use in the electromagnetic environme
Emissions Test RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage Fluctuations/ Flicker emissions Group 1 Compliance Class B REAL System 2 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. REAL Immersive System is suitable for use in all establishments other than domestic and those directly connected to the public mains.
(50/60 Hz) magnetic field IEC 61000-4-8 Voltage Interruptions > 95% reduction, 250/300 periods 30 A/m Voltage Interruptions > 95% reduction, 250/300 periods 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical residential or rehabilitation environment. REALTM System 2 is intended for use in the electromagnetic environment specified below. The customer or the user of REAL System 2 should assure that it is used in such an environment.
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating REAL System 2. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and REAL System 2 REAL System 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
modulation b) 217 Hz 745 780 810 870 Pulse modulation b) 18 Hz 2 0.3 28 Pulse modulation b) 217 Hz 2 0.3 28 2400 – 2570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Pulse modulation b) 217 Hz 2 0.3 28 5100 – 5800 WLAN 802.11 a/n Pulse modulation b) 217 Hz 0.2 0.
2. L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Les changements ou les modifications qui n’ont pas été expressément approuvés par la partie responsable de la conformité peuvent faire perdre à l’utilisateur son droit d’utiliser l’appareil.
Device WSM WTM Antenna Make HMD Penumbra, Inc. Johanson Antenna Model P/N 2450AT43B100E P/N 17107 Antenna Gain Peak Gain 1.3 dBi Average Gain -0.5 dBi Peak Gain 0.7 dBi Average Gain -2.6 dBi Power Output and Data Rate: Device WSM WTM HMD Power Output Programmed by the firmware to +8dBm. Programmed by the firmware to +4dBm. Programmed by the firmware to +8dBm. Data Rate GFSK modulation, 2 Mbps data rate. Product availability varies by country. Please see www.realsystem.com for more information.
Remove the exposed equipment from the body. Power down the headset if possible and do not put the sensors back in the charging station. Do not use the equipment. Pat dry the wet equipment. Call the REAL help line. 10. Web application does not launch on the computing device: Make sure the computing device is connected to internet and the URL is correct (list URL HERE). 11. Cannot log in to the web application: Make sure the username and/or password is correct. 12.
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