neo monitor

Device Name

neo monitor system

Model / Reference

ES-820

Primary DI / UDI-DI

+B195ES820

Basic UDI-DI

++B195ES820V8

EMDN Code

Z12100302 Electroencephalographs

Device Class

Class IIa

Medical Purpose

nëo monitor is indicated for use on healthy and (critically) ill neonates to record and review the cerebral activity of newborn infants, to monitor patients for: • brain state and development • sleep-wake cycles • abnormal background patterns (burst suppression, flat trace, etc.) and for monitoring / diagnosis of patients: • with hypoxic-ischemic encephalopathy (HIE) • with clinical seizures (or suspicion thereof) • for whom there is an indication for hypothermia therapy • at high risk of brain injury NB. The device is a reusable instrument sold in a non-sterile state. Decontamination between patient monitoring episodes is advised.

EUDAMED SRN

DE-PR-000053067

• waveguard original

  Class I

  CE/MDR

• waveguard net

  Class I

  CE/MDR

• waveguard

  Class I

  CE/MDR

• waveguard original

  Class I

  CE/MDR

• waveguard original

  Class I

  CE/MDR

• waveguard original

  Class I

  CE/MDR

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