AS/3 ESTPR MODULE
Device Facts
| Record ID | K953175 |
|---|---|
| Device Name | AS/3 ESTPR MODULE |
| Applicant | Datex Division Instrumentarium Corp. |
| Product Code | MLD · Cardiovascular |
| Decision Date | Feb 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1025 |
| Device Class | Class 2 |
Intended Use
The AS/3™ ESTPR module is intended to be used in the Datex AS/3™ Anaesthesia Monitor or in the AS/3™ Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.
Device Story
AS/3™ M-ESTPR module; component of AS/3™ modular anesthesia monitoring system. Inputs: ECG, SpO2, 2 invasive pressure, 2 temperature, impedance respiration. Operation: module hardware captures signals; respiration signal processed by module software; data transmitted to AS/3™ central monitor unit. Central unit performs waveform analysis, respiration rate calculation, alarm management, trending, and display. Used in anesthesia departments, recovery rooms, ORs; operated by clinicians. Benefits: integrated multi-parameter monitoring for patient safety during anesthesia.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Modular anesthesia monitor component. Parameters: ECG, SpO2, 2x invasive pressure, 2x temperature, impedance respiration. Connectivity: integrated with Datex AS/3™ Anaesthesia or Compact Monitor central units. Software-based signal processing for respiration waveform analysis.
Indications for Use
Indicated for patients requiring monitoring of ECG, SpO2, invasive pressure, temperature, and impedance respiration in anesthesia, recovery, or operating room settings.
Regulatory Classification
Identification
The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
Predicate Devices
- M-ESTP (K953175)
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