APDM Mobility Lab

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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 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 Mobility Lab system Opal is a Type B Applied Part, i.e., a part of the system which comes into contact with the patient. The Mobility Lab

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 Mobility Lab 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 Mobility Lab 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 Mobility Lab 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 Mobility Lab system can only be connected to a host computer via the USB Micro-B connector.

INFORMATION

Parts

Setup M.L. How to