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

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
09-11-2017

から入手可能:

Integra Neurosciences Pty Ltd

クラス:

Class III

製:

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

治療領域:

30204 - Electrode, ion selective, oxygen

適応症:

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.

認証ステータス:

A

承認日:

2014-01-06

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