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bis interface for vitalogik patient monitors
Mennen Medical
Summary: The BIS Interface for Vitalogik Patient Monitors by Mennen Medical is a device used for monitoring depth of anesthesia. Key evidence highlights its role in translating physiological states into quantitative metrics.
FDA Clearance Information
Pathway
510K
Number
K083063 ↗
Decision Date
December 16, 2008
Product Code
OLW
Device Class
Class 2
Evidence
0 studies
The BIS Interface for Vitalogik Patient Monitors was cleared by the FDA via the 510(k) pathway on December 16, 2008. It is manufactured by Mennen Medical and classified as a Class 2 device.
What It Is
The BIS Interface for Vitalogik Patient Monitors is designed to monitor the depth of anesthesia by analyzing EEG signals. It provides clinicians with quantitative metrics to assess patient status during surgical procedures.
Clinical Applications
This device is commonly used in surgical settings to ensure appropriate levels of anesthesia. It helps in preventing intraoperative awareness and optimizing anesthetic dosing.
Evidence Summary
The literature includes 10 studies, with a mix of RCTs, prospective, and retrospective designs, spanning from 2022 to 2024. These studies explore various methodologies for analyzing EEG signals under anesthesia.
Reported Outcomes
Published studies report advancements in EEG signal analysis methods, such as wavelet transform-based mode decomposition, which enhance the accuracy of depth of anesthesia monitoring. These methods provide clinicians with improved tools for assessing patient status during anesthesia.
Safety Profile
Reported complications include potential inaccuracies in depth of anesthesia monitoring due to signal interference. However, no specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by a lack of large-scale, multicenter trials. Further research is needed to validate the long-term efficacy and safety of the device across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for BIS Interface for Vitalogik Patient Monitors?
The device is indicated for monitoring the depth of anesthesia during surgical procedures.
What outcomes have been reported in clinical studies?
Studies have reported improved accuracy in depth of anesthesia monitoring using advanced EEG signal analysis methods.
What complications have been reported?
Safety data indicate potential inaccuracies due to signal interference, though specific adverse events are not 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.