(254 days)
The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.
The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control. The operation of the CO2 Sidestream 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 the energy 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. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for 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). Respiration rate is calculated by measuring the time interval between detected breaths.
The provided text describes the acceptance criteria and a study demonstrating the device's compliance.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| EtCO2 Measurement Range | 0-150 mmHg, 0-19.7%, 0-20 kPa |
| EtCO2 Accuracy | 0-40 mmHg: ±2 mmHg |
| 41-70 mmHg: ±5% of reading | |
| 71-100 mmHg: ±8% of reading | |
| 101-150 mmHg: ±10% of reading | |
| Respiration Rate Measurement Range | 3 - 150 breaths/minute (RPM) |
| Respiration Rate Accuracy | ±1% of reading or ±1 breaths/min, whichever is greater |
| In Vitro Cytotoxicity | Viability%: 87.9% (No toxicity) |
| Skin Sensitization | 0% skin sensitization rate (No evidence of sensitization) |
| Skin Irritation | Primary irritation index: 0 (Negligible) |
| Emissions of Particulate Matter | Particulate Matter: $3.2 \times 10^{-3}$ µg/m3 (Particle size ≤2.5 μm) |
| $3.2 \times 10^{-3}$ µg/m3 (Particle size ≤10 μm) (Qualified) | |
| Emissions of Volatile Organic Compounds | Each VOC |
§ 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).