CO2 Rebreathing Tester | ISO 17510:2015 Carbon Dioxide Rebreathing Tester

Professional Construction & Technical Precision

The CO2 Rebreathing Tester is built with premium laboratory-grade components and a high-performance PLC control system integrated with a 7-inch color touchscreen, delivering precise parameter control and intuitive real-time monitoring for operators of all experience levels. The anatomically accurate PVC head mold features a quick-install breathing pipe and a built-in 200 mL dead space that faithfully replicates human respiratory physiology, while the high-precision infrared CO2 analyzer—paired with an integrated sampling pump—provides fast, stable, and highly repeatable gas concentration readings.

A fully programmable breathing simulator generates realistic sinusoidal waveforms at 15 breaths per minute with a 0.5 L tidal volume and 1:2 inspiratory-to-expiratory ratio. Combined with differential pressure sensors (0–2000 Pa) and adjustable positive airway pressure up to 30 kPa, the system ensures comprehensive and repeatable testing across the exact conditions defined in ISO 17510:2015 Annex F.

Testing Principle

The CO2 Rebreathing Tester quantifies the effectiveness of exhaust ports in sleep apnoea masks and patient interfaces by simulating realistic breathing conditions and measuring the amount of exhaled carbon dioxide that is re-inhaled. A breathing simulator delivers a controlled mixture of CO2-enriched gas through the PVC head mold and test mask under regulated positive airway pressure. The infrared analyzer continuously samples and records CO2 levels inside the mask during both normal operation and defined single-fault conditions, such as a blocked breathing tube.

According to ISO 17510:2015 Annex F, the relative CO₂ increase must remain below 20 % under normal conditions (tested at the minimum rated pressure, 5 hPa, and 10 hPa) and must not exceed 60 % under single-fault conditions. This precise, quantitative evaluation confirms that the mask design effectively vents exhaled gases, safeguarding patients against the risks of hypercapnia and ensuring compliance with international patient-safety requirements.

Common Error Mitigation

To achieve consistently accurate, repeatable, and fully ISO 17510:2015-compliant results with the CO2 Rebreathing Tester, the following best practices are strongly recommended:

• Calibrate the infrared CO2 analyzer and differential pressure sensors immediately before each test series using certified reference standards.
• Verify that the test mask is securely and leak-free fitted onto the PVC head mold with the breathing circuit properly connected.
• Confirm that all breathing simulation parameters (rate, tidal volume, waveform, and pressure settings) exactly match the requirements of ISO 17510:2015 Annex F.
• Always use clean, dry compressed air and the supplied high-purity CO2 source to prevent contamination or measurement drift.
• Log complete test data—including full CO2 concentration curves, pressure profiles, fault conditions, and timestamps—for complete traceability and regulatory audit readiness.

Primary Use Cases & Business Value

The CO2 Rebreathing Tester serves as a critical validation tool for medical device manufacturers developing CPAP, BiPAP, and other sleep apnoea therapy masks. It enables early detection of exhaust-port design flaws during the development phase, streamlines regulatory submission processes, and significantly reduces the likelihood of costly post-market safety issues or patient complaints. By delivering reliable, repeatable test data, the system helps companies accelerate product certification, enhance overall device performance, and build stronger confidence among clinicians and patients worldwide.

Industrial Applications & Lab Scenarios

• Sleep Apnoea Mask Manufacturers — Comprehensive CO2 rebreathing validation for nasal, full-face, hybrid, and pediatric masks
• Positive Airway Pressure Device Producers — Full interface compatibility and performance testing per ISO 17510:2015
• Medical Device Certification Laboratories — Independent type approval and regulatory compliance verification
• R&D and Product Development Teams — Rapid iteration and performance benchmarking of new mask designs

Strategic Procurement Advantages & Global Support

• Complete ISO 17510:2015 Annex F compliance with a single, ready-to-use testing platform
• Intuitive 7-inch touchscreen PLC interface that dramatically reduces operator training time and testing cycle duration
• Fully integrated system—including head mold, breathing simulator, CO2 supply, and calibration documentation—for immediate laboratory deployment
• Robust, long-term reliability backed by traceable factory calibration and premium component selection
• Manufactured under ISO 9001 and ISO 17025 certified quality management with responsive global technical support