đź“Š Evidence-Based Reference
datex-ohmeda s 5 device interfacing solution n-disxxxx 01 with n-disvent 02
Ge Healthcare
Summary: The Datex-Ohmeda S 5 Device Interfacing Solution by GE Healthcare is used for interfacing with anesthesia devices. It is FDA 510(k) cleared. Key evidence highlights potential user interface challenges.
FDA Clearance Information
Pathway
510K
Number
K070421 ↗
Decision Date
March 13, 2007
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 March 13, 2007. Manufactured by GE Healthcare, it is classified as a Class 2 device.
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 device interoperability.
Clinical Applications
This device is commonly used in operating rooms and intensive care units to integrate anesthesia machines with patient monitors, ensuring seamless data exchange and improving workflow efficiency.
Evidence Summary
The available literature includes two studies from 2003 and 2006. These studies explore user interface challenges and potential improvements through speech interaction technology.
Reported Outcomes
Published studies report challenges with the user interface of the Datex-Ohmeda M-NMT Module, suggesting potential confusion for users. Another study discusses the potential of speech interaction to address interaction problems in anesthesia settings.
Safety Profile
Reported complications include user interface confusion, which may impact device usability. No specific adverse events or complications are detailed in the provided evidence.
Evidence Limitations
The evidence is limited to two studies, with a focus on user interface and interaction challenges. Further research is needed to explore broader clinical outcomes and safety data.
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 machines with monitoring systems to improve data integration and workflow in clinical settings.
What outcomes have been reported in clinical studies?
Studies have reported on user interface challenges and the potential for speech interaction to improve device usability.
What complications have been reported?
Safety data from evidence indicates potential user interface confusion, but no specific adverse events are 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.