← Product Code [MLD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD) · K953175

# AS/3 ESTPR MODULE (K953175)

_Datex Division Instrumentarium Corp. · MLD · Feb 6, 1997 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K953175

## Device Facts

- **Applicant:** Datex Division Instrumentarium Corp.
- **Product Code:** [MLD](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD.md)
- **Decision Date:** Feb 6, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1025
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Indications for 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.

## Regulatory 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](/device/K953175.md))

## Submission Summary (Full Text)

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{0}

Datex

K953175

FEB - 6 1997

510(k) SUMMARY

05.07.95

Datex Division
Instrumentarium Corp.
P.O. Box 446
FIN-00101 Helsinki
Finland
Tel: +358 0 39411
Fax: +358 0 1463310

Contact person: Rauno Ruoho

## PRODUCT NAMES

Device name: AS/3™ M-ESTPR

Common name: Electrocardiographic Device

## DESCRIPTION OF THE DEVICE

The AS/3™ ESTPR Module is a part of the modular anesthesia monitoring system AS/3™. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements.

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.

The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration signal. Then the signal is sent to the AS/3™ Anaesthesia or Compact Monitor central unit. The AS/3™ monitor software receives the respiration signal from the ESTPR module, analyzes the respiration waveform, displays respiration rate and waveform, handles the alarms, trending and other general monitor features.

The hardware and software of ECG, SpO2, pleth, invasive pressure and temperature measurements of M-ESTPR are same as in the M-ESTP.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K953175](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MLD/K953175)

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