(59 days)
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.
The CO2 Mainstream module is a non-dispersive infrared gas analyzer with an auto-zero adjustment systemand gain control. The operation of the CO2 Mainstream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to theenergy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the module's memory. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent(%), or kilopascals (kPa). In addition, a CO2 waveform (Capnogram) may be displayed, which is a valuable clinical tool that can be used to assess patient airway integrity and proper endotracheal tube placement. Respiration rate is calculated by measuring the time interval between detected breaths.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Unimed CO2 Mainstream Module:
1. A table of acceptance criteria and the reported device performance
The provided document describes acceptance criteria in the context of "EtCO2 Accuracy" and "Respiration Rate Accuracy." It also states that the device complies with ISO 80601-2-55. The table below combines the reported performance with these accuracy criteria.
| Metric | Acceptance Criteria (Specified in the text as EtCO2 Accuracy / Respiration Rate Accuracy) | Reported Device Performance (Implied by the criteria, stated as matching the predicate) |
|---|---|---|
| EtCO2 Accuracy (at 760 mmHg, ambient temperature of 25°C) | 0~40 mmHg ±2 mmHg | |
| 41~70 mmHg ±5% of reading | ||
| 71~100 mmHg ±8% of reading | ||
| 101~150mmHg ±10% of reading | 0~40 mmHg ±2 mmHg | |
| 41~70 mmHg ±5% of reading | ||
| 71~100 mmHg ±8% of reading | ||
| 101~150mmHg ±10% of reading | ||
| Respiration Rate Accuracy | ±1% of reading or ±1 breaths/min, whichever is greater | ±1% of reading or ±1 breaths/min, whichever is greater |
| CO2 Response Time |
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).