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datex-ohmeda s 5 device interfacing solution
Ge Healthcare
Summary: The Datex-Ohmeda S 5 Device Interfacing Solution by GE Healthcare is a medical device cleared by the FDA for interfacing with anesthesia equipment. Key evidence highlights potential user interface challenges and explores speech interaction technology.
FDA Clearance Information
Pathway
510K
Number
K051634 ↗
Decision Date
July 19, 2005
Product Code
MSX
Device Class
Class 2
Evidence
0 studies
The Datex-Ohmeda S 5 Device Interfacing Solution was cleared via the FDA 510(k) pathway on July 19, 2005. It is manufactured by GE Healthcare and classified as a Class 2 device under product code MSX.
What It Is
The Datex-Ohmeda S 5 Device Interfacing Solution is designed to facilitate communication between anesthesia devices and monitoring systems. It is intended for use in clinical settings to enhance data integration and workflow efficiency.
Clinical Applications
This device is commonly used in operating rooms and anesthesia departments to streamline the monitoring and documentation of anesthetic procedures. It supports clinicians in managing patient data and device interactions.
Evidence Summary
The available literature includes two studies published between 2003 and 2006. These studies explore user interface challenges and the potential for speech interaction technology in clinical settings.
Reported Outcomes
Published studies report that the Datex-Ohmeda S 5 Device Interfacing Solution may present user interface challenges. Additionally, the potential for speech interaction technology to improve documentation processes in anesthesia settings has been noted.
Safety Profile
Reported complications include potential confusion due to the user interface, as highlighted in one study. No specific adverse events or complications were detailed in the available evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety and efficacy outcomes. Further research is needed to evaluate the long-term impact of the device and its integration with emerging technologies.
Frequently Asked Questions
What are the clinical indications for Datex-Ohmeda S 5 Device Interfacing Solution?
The device is indicated for use in interfacing anesthesia equipment with monitoring systems to enhance data integration and workflow efficiency.
What outcomes have been reported in clinical studies?
Studies have reported potential user interface challenges and the possibility of using speech interaction technology to improve documentation.
What complications have been reported?
Safety data from evidence indicates potential confusion due to the user interface, but no specific adverse events were detailed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.