ATTACHMENT A-Salient Characteristics-NIM STIMULATOR 0823.docx

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6515--(C) (E) Forecast 575 - Replacement NIM stimulator / EER 154543 (VA-22-00068214)
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36C25922Q0660
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Attachment B- VAAR Clause 852.219-78 VA Notice of Limitations on Subcontracting-Certificate of Compliance 0823.docx DOCX document

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ATTACHMENT A

Salient Characteristics

The system may be used for EMG monitoring in support of surgical procedures including intracranial, extracranial, intra-temporal, extratemporal and surgeries associated with the neck, spine, thorax, and upper and lower extremities. The system is an intraoperative EMG monitor that enables users to locate and confirm the integrity of nerves during surgical procedures. The system stimulates nerves (propagates an action potential) through a variety of stimulation probes that causes the muscle associated with the nerve to contract. The system then picks up these electric signals from the muscles through a variety of electrodes and converts this information into meaningful graphs and sounds that the system displays on the monitor. The system also continuously monitors EMG activity from the muscles innervated by the nerve at risk Must have setting specific to thyroidectomy. Must have Nerve Integrity Monitoring ET tubes. Must have audio and visual clues to ensure no damage done to nerves intraoperatively.

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