SPINAL elements

Neuro Check System

Neuro Check Device Instructions for Use Rev U July 2019

Instructions for Use

34 Pages

Instructions for Use Neuro Check® device with Wire DEVICE DESCRIPTION: The Neuro Check® device assists in the localization of nerve roots during spinal surgery where visualization is  limited. The Neuro Check is designed to route electrical stimulus signals from a standard Electromyography (EMG) System to two sets of electrodes on the device in order to make an assessment as to relative nerve root location. It is comprised of a proximal handle, a rigid shaft, and a thin flexible distal platform featuring an array of electrodes on the top and bottom surfaces with embedded radiopaque markers (See Figure 1 below). Flexible Platform  Cable  Rigid Shaft  Switch  Figure 1: Neuro Check device Electrodes  Tip  Radiopaque Markers  Figure 2: Flouroscopic Image of Flexible Electrode Platform HOW SUPPLIED: The iO-Flex® Neuro Check device is supplied sterile for single-patient use and is packaged with the iO-Flex® Wire to facilitate placement of the Neuro Check device and other iO-Flex®devices. Order Number  Description  iO-NCW  iO-Flex Neuro-Check with Wire  LBL1210 Rev. U (DCR 19-0013, Effective Date: 2019-07-25)  Page 1 - 17
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