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datex-ohmeda s 5 interface module e-int
Ge Healthcare
Summary: The Datex-Ohmeda S/5 Interface Module E-INT by GE Healthcare is a medical device used in clinical settings for interfacing with monitoring systems. It is primarily used by anesthesiologists and other perioperative care providers.
FDA Clearance Information
Pathway
510K
Number
K052880 ↗
Decision Date
November 2, 2005
Product Code
CCK
Device Class
Class 2
Evidence
0 studies
The Datex-Ohmeda S/5 Interface Module E-INT was cleared through the FDA 510(k) pathway on November 2, 2005. Manufactured by GE Healthcare, it is classified as a Class 2 device under product code CCK.
What It Is
The Datex-Ohmeda S/5 Interface Module E-INT is a component of the S/5 monitoring system, designed to facilitate communication between various monitoring modules and the central display unit. It integrates data from multiple sources, allowing clinicians to monitor vital signs and other parameters efficiently. This interface module is crucial in operating rooms and intensive care units, where continuous patient monitoring is essential.
Clinical Applications
This device is commonly used in surgical and critical care settings, where real-time monitoring of patient vitals is critical. Anesthesiologists and critical care specialists rely on it to track parameters such as heart rate, blood pressure, and respiratory status. It is particularly useful in complex surgeries and in managing patients with critical illnesses, providing a comprehensive view of the patient's physiological status.
Indications for Use
The FDA indications for the Datex-Ohmeda S/5 Interface Module E-INT involve its use in integrating and displaying patient monitoring data. It is intended for patients requiring continuous monitoring, such as those undergoing surgery or in intensive care units.
Practical Considerations
The module is designed to be compatible with the Datex-Ohmeda S/5 monitoring system, ensuring seamless integration. Clinicians should be familiar with the interface to optimize its use. Proper setup and calibration are essential for accurate data display.
Related Literature
The linked study, titled 'The Datex-Ohmeda M-NMT Module: a potentially confusing user interface,' was conducted in 2006. Although the abstract is not available, the study likely explored user interface challenges associated with the module. Key findings might include potential areas for user error or confusion, emphasizing the importance of proper training. The study's limitations include the lack of an abstract and potentially limited sample size.
Frequently Asked Questions
What is the Datex-Ohmeda S/5 Interface Module E-INT used for?
It is used for integrating and displaying patient monitoring data in surgical and critical care settings.
What specialties typically use this device?
Anesthesiology and critical care medicine are the primary specialties that use this device.
What are the FDA-cleared indications?
The device is indicated for use in integrating and displaying data from patient monitoring systems, particularly in surgical and intensive care environments.
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.