Search Results

The AS/3™ ESTPR module is intended to be used in the Datex AS/3" Anaeshesia Monitor or in the AS/3" Compact Monitor in anesthesia department, in recovery rooms, operation theatres etc.

The AS/300 ESTPR Module is a part of the modular anesthesia monitoring system AS/300. It provides ECG, SpO2, 2 invasive pressure and 2 temperature channels and impedance respiration measurements. The impedance respiration measurement hardware is in the ESTPR module. The ESTPR Module software measures the respiration 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.

I am sorry, but the provided text only details a 510(k) summary for a medical device called "AS/3™ M-ESTPR," an electrocardiographic device. It describes its function as part of a modular anesthesia monitoring system and lists the physiological parameters it measures (ECG, SpO2, invasive pressure, temperature, and impedance respiration).

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance for specific clinical outcomes.
• Details of any study that proves the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC, standalone).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Ask a specific question about this device