LICOX Combined Oxygen and Temperature Probe, CC1.P1 - Electrode, ion selective, oxygen

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Laporan Penilaian Awam Laporan Penilaian Awam (PAR)
09-11-2017

Boleh didapati daripada:

Integra Neurosciences Pty Ltd

Kelas:

Class III

Dikeluarkan oleh:

Integra NeuroSciences Implants SAS 2905 Route Des Dolines, Sophia Antipolis, Cedex, 06921 France

Kawasan terapeutik:

30204 - Electrode, ion selective, oxygen

Tanda-tanda terapeutik:

The combined oxygen and temperature probe may be used for monitoring of oxygen partial pressure as well as temperature in the cerebral white matter. The probe may be implanted after craniotomy through a burr or drill hole at the margin of an existing bone flap. The oxygen sensing starts 4 to 6 mm from the tip of the probe. The temperature sensing part starts 13 to 15 mm from the end of the probe?s oxygen sensing part. The system is designed for no more than five days of continuous monitoring A flexible sensor probe that is part of the Licox Brain Oxygen Monitoring System measures intracranial oxygen and temperature and is intended as an adjunct monitor of trends of these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. Licox System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice in cases where hypoxia or ischemia are a concern.

Status kebenaran:

A

Tarikh kebenaran:

2014-01-06

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