đź“Š Evidence-Based Reference
As 3 Tm Anesthesia Monitor Syst Interface Board
Datex Division Instrumentarium
Summary: The AS 3 TM Anesthesia Monitor System Interface Board by Datex Division Instrumentarium is an FDA-cleared device used in anesthesia monitoring. Key evidence includes studies on its application in various clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K935477 ↗
Decision Date ?
August 1, 1994
Product Code ?
CCK
Device Class ?
Class 2
Evidence ?
0 studies
The AS 3 TM Anesthesia Monitor System Interface Board was cleared by the FDA via the 510(k) pathway on August 1, 1994. It is manufactured by Datex Division Instrumentarium and classified as a Class 2 device.
What It Is
The AS 3 TM Anesthesia Monitor System Interface Board is designed to integrate with anesthesia monitoring systems, providing clinicians with real-time data on patient vitals during surgical procedures. It is intended for use in perioperative settings to enhance patient monitoring.
FDA-Cleared Indications
- For use as an interface component within the AS 3 TM Anesthesia Monitor System.
- For monitoring and communicating patient physiologic information during anesthesia and perioperative care, when used with the compatible monitoring system.
Clinical Applications
- Integration of monitoring signals within an anesthesia monitoring system.
- Monitoring patient physiologic parameters during surgical procedures performed under anesthesia.
- Use in operating rooms and other perioperative care settings with compatible anesthesia-monitoring equipment.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and other study types, published between 2016 and 2025. These studies explore the device's efficacy and safety in various clinical scenarios.
Reported Outcomes
Published studies report that the AS 3 TM Anesthesia Monitor System Interface Board effectively supports perioperative monitoring, potentially reducing postoperative complications. Specific outcomes include improved intraoperative management and enhanced patient safety.
Safety Profile
Reported complications include potential device malfunctions and data inaccuracies, which could impact patient monitoring. However, no significant adverse events have been consistently documented in the reviewed studies.
Evidence Limitations
The evidence base is limited by the small number of studies directly evaluating the device's long-term impact. Further research is needed to assess its efficacy across diverse patient populations and surgical settings.
Practical Considerations
- This is an interface board or system component, not an independent patient-monitoring device; it requires compatible Datex or Instrumentarium equipment.
- Confirm system compatibility, connector configuration, software requirements, and service documentation before installation or replacement.
- The available FDA record does not specify a universal patient size range, vessel access requirement, or standalone use.
- MRI compatibility is not established by the information provided. Do not bring the component into an MRI environment unless the complete system has been specifically labeled for that setting.
- Follow the manufacturer’s instructions for installation, electrical safety, cleaning, maintenance, and replacement; malfunction may affect monitoring-system information.
Frequently Asked Questions
What are the clinical indications for AS 3 TM Anesthesia Monitor System Interface Board?
The device is indicated for use in anesthesia monitoring during surgical procedures, providing real-time data on patient vitals.
What outcomes have been reported in clinical studies?
Studies have reported improved intraoperative management and reduced postoperative complications with the use of this device.
What complications have been reported?
Reported complications include potential device malfunctions and data inaccuracies, though significant adverse events are not consistently documented.
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.