APDM Opal V2R - Intended Use Statement; Opal V2 R System Description; Contraindications; Warnings and Precautions

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INFORMATION
Parts
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Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Parts
Setup M.L. How to
M.L. Software Download Troubleshooting
Hardware Cong
Tech Stats/Info
Information about Opal V2R System
Intended Use Statement
The Opal V2R is a small worn monitor designed for documenting physical movement associated with applications in research and
engineering. The Opal V2R can be used in any instance where quantiable analysis of physical motion is desirable. Intended uses include
motion detection, quantication of motion. quantication of movement, and quantication of human movement. Application uses include
motion research, biomechanics, sports, tness, and animation.
Opal V2R System Description
The Opal V2R System (“Opal System”) is a research-grade system comprised of one or more Opal V2R (“Opal”) wearable sensors, a Docking
Station to recharge the Opal’s battery and transfer the raw sensor data logged to a computer, an Access Point to enable wireless streaming,
adjustable straps for a variety of body locations, and Opal application software (Motion Studio, Mobility Lab, or Moveo Explorer) that
provides functionality for 1) conguring the Opals, 2) collecting and storing Opal data, 3) analyzing and visualizing the collected data, and 4)
exporting the data in various formats.
Contraindications
Do not apply Opals or the Opal straps to broken or otherwise non-intact skin. Opals and straps should not be used in conjunction with an
MRI. Not a medical device. Medical uses require APDM’s Opal V2C System (FDA Class II Medical Device, CE Class I Medical Device; Rx
Only).
Warnings and Precautions
The Motion Studio system Opal is a Type B Applied Part, i.e., a part of the system which comes into contact with the patient. The Motion
Studio system Docking Station, Access Point, USB cables, and Docking Station power supply are not applied parts, and are not intended to
come into contact with the subject. Opals should be cleaned in between subjects. SeeTips section on page 35 for cleaning directions.
Do not open any Motion Studio hardware enclosures; there are no user serviceable parts inside. The Opals contain a rechargeable lithium
ion battery which is not intended to be replaced by the user.
The Motion Studio Docking Station should only be powered by the provided 12V 2A center positive power adapter. Do not use other power
adapters with the Docking Station.
The Motion Studio Docking Station has a spare USB Type A port. Only attach USB peripherals and cables that comply with the USB 2.1
specication. The Motion Studio system can only be connected to a host computer via the USB Micro-B connector.