AS/3 NMT MODULE
Device Facts
| Record ID | K955026 |
|---|---|
| Device Name | AS/3 NMT MODULE |
| Applicant | Datex Medical Instrumentation, Inc. |
| Product Code | KOI · Anesthesiology |
| Decision Date | Apr 28, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.2775 |
| Device Class | Class 2 |
Indications for Use
The product is designed to be used for monitoring relaxation of patient during and after anesthesia and for regional block stimulation for nerve location. The intended environment of use is anesthesia department, including operation rooms (OR) and post-anesthesia care units (PACU) etc.
Device Story
AS/3 M-NMT module; component of AS/3 anesthesia monitoring system. Function: neuromuscular transmission monitoring and nerve location via regional block stimulation. Operation: module stimulates patient; measures response; transmits data to AS/3 anesthesia or compact monitor central unit. Central unit software calculates NMT values, displays data, manages trends, and provides monitoring features. Used in OR and PACU by anesthesia clinicians. Output assists in assessing patient relaxation levels and guiding nerve block procedures.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Modular anesthesia monitoring component; hardware-based stimulation and response measurement; integrates with AS/3 anesthesia or compact monitor central unit; software-driven calculation and display.
Indications for Use
Indicated for monitoring neuromuscular relaxation in patients undergoing anesthesia and for regional block stimulation for nerve location in clinical settings including OR and PACU.
Regulatory Classification
Identification
An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.
