REAL™ IMMERSIVE SYSTEM USER MANUAL 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 • 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 Specifications 13 Symbol Glossary 13 Technical Information 13 WAR
DEVICE DESCRIPTON The REAL® Immersive System is a digital hardware and software medical device platform utilizing virtual reality technology designed for use in a clinical environment, or any other facility that may facilitate rehabilitation, setting that focuses on physical, neurorehabilitation and/or wellness needs.
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. Headset tracking can be lost or compromised if large objects obscure the headset.
• skin irritation Should any of the above occur, stop using the device immediately. 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.
4. Ensure the headset is connected to its power cord (USB-C cord). LED lightson top of headset will only show blinking green or solid green to indicate charging status. 3. Turn on headset by pressing and holding power button for approximately 5 seconds. 5. Ensure the tablet is connected to its power cord (USB-C cord). 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.
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 fi t, if necessary. 12.
Section 4: THERAPY ACTIVITIES 1. Confirm patient’s avatar in VR space corresponds to actual patient’s physical movement. 7. View patient results on tablet. You may also switch to the Notes tab for a summary of session and activity times. 2. Confirm 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.
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. Therapy Activity 1: Hide and Seek 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.
Therapy Activity 2: Hot Air Balloon Therapy Activity 3: Sunrise 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.
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. Sub-Activity 3: Ice Cave The Ice Cave sub-activity involves freeing a variety of Cave Penguins from ice blocks by raising and lowering one’s arms a number of times in order to trigger the appearance of day-night cycles.
Therapy Activity 4: Bird Forest Therapy Activity 5: Penguin Sports Park The Bird Forest activity incorporates standard functional exercises including dynamic reaching and pronation/supination into a virtual reality activity by requiring the patient to reach out with one or both hands to allow a bird to jump into their hand. Patients have opportunities to reach from low to high, high to low, from left to right and vice versa to practice functional reach.
TECHNICAL SPECIFICATIONS TECHNICAL INFORMATION Sensor Accuracy* ± 2 cm at a max distance of 75 cm Sensor Precision* 2 cm or less Latency ≤35 milliseconds Operating Temperature 15°C to 30°C Operating Pressure 102 kPa or less Operating Relative Humidity 30% to 90% Operating Elevation 2,500 meters or less Radio Module Output power (EIRP*): 6.31 mW (8 dBm) max Frequency Band: ISM (Industrial, Scientific, and Medical) Typical Center frequency: 2.
Immunity to RF Wireless Communications Equipment REAL™ Immersive System is intended for use in the electromagnetic environment specified below. The customer or the user of REAL Immersive System should assure that it is used in such an environment. Immunity test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 test level Compliance level 3 Vrms 150 kHz to 80 MHz (6 Vrms in ISM radio Bands within 150kHz – 80MHz) 10 V/m 80 MHz to 2.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential setting. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications.
Manufacturer: Penumbra Inc. One Penumbra Place Alameda, CA 94502 USA Tel: 1.855.REAL-SYS 1.855.732.5759 13661.
