AS/3 LIGHT MONITOR

K961247 · Datex Division Instrumentarium Corp. · DPS · Oct 23, 1996 · Cardiovascular

Device Facts

• Record ID: K961247
• Device Name: AS/3 LIGHT MONITOR
• Applicant: Datex Division Instrumentarium Corp.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Indications for Use

AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient’s vital signs.

Device Story

Portable patient monitor; measures ECG, invasive blood pressure, SpO2, temperature, and NIBP. Configurations: LM (ECG, SpO2, 1 temp, NIBP) or LMP (ECG, SpO2, 2 invasive pressures, 2 temps, NIBP). Operates on battery or mains power. Used in clinical settings for continuous vital sign monitoring. Provides real-time physiological data to clinicians to support patient assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device tested against established specifications of the predicate AS/3 Compact Monitor to confirm equivalent performance.

Technological Characteristics

Portable patient monitor; measures ECG, invasive/non-invasive blood pressure, SpO2, and temperature. Powered by battery or mains. Utilizes same measurement techniques and algorithms as predicate AS/3 Compact Monitor.

Indications for Use

Indicated for patients requiring stationary or mobile indoor monitoring of vital signs, including ECG, invasive blood pressure, SpO2, temperature, and non-invasive blood pressure (NIBP).

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Datex AS/3™ Compact Monitor with ESTP and NIBP modules

Submission Summary (Full Text)

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Datex
K961247

510(k) SUMMARY
OCT 23 1996
27 March, 1996

Datex-Engström Division
Instrumentarium Corp.
P.O. Box 446
FIN-00101 Helsinki
Finland
Tel: [phone]
Fax: [phone]

Contact person: Rauno Ruoho

## PRODUCT NAMES

Device name: AS/3™ Light Monitor

Common name: Hemodynamic measurement device

## DESCRIPTION OF THE DEVICE

AS/3 Light Monitor is a portable patient monitor which measures ECG, 2 invasive blood pressures, oxygen saturation SpO₂, 2 temperatures and non-invasive blood pressure NIBP. The measurement technics are similar to the AS/3 Compact Monitor with ESTP module and NIBP module. See section 3 for details.

AS/3 Light Monitor will be available in two following configurations:
- LM which measures ECG, SpO₂, 1 temperature and NIBP
- LMP which measures ECG, SpO₂, 2 invasive blood pressures, 2 temperatures and NIBP.

The monitor can be driven with battery or with mains power.

## INTENDED USE

AS/3 Light Monitor is intended for stationary and mobile indoor monitoring of a patient’s vital signs.

## SUBSTANTIAL EQUIVALENCE

In terms of overall functions and parameters measured, the AS/3™ Light Monitor is substantially equivalent in safety and effectiveness to Datex AS/3™ Compact Monitor with ESTP and NIBP modules.

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Measurement parameters are the same as in Datex AS/3™ Compact Monitor with ESTP and NIBP modules. Measurement units are redesigned, but measurement technics and algorithms are the same.

The specifications of the monitors were compared and AS/3™ Light Monitor was tested against the specifications. The results showed that AS/3™ Light Monitor is substantially equivalent with AS/3™ Compact Monitor.