MediPines Advanced Single Patient Breathing Circuit

AGM100 (5)

The MediPines Single Patient Use Breathing Circuit is specially designed to work with The MediPines Gas Exchange Monitor (AGM100®).

  • Specifically engineered and optimized for sampling challenged patients’ normal breathing gas.
  • Advanced engineering to provide optimal results from MediPines AGM100®.

Specially Engineered and Optimized for Breathing Gas Sampling

Cleared for use with the AGM100 under FDA 510(k) K180902, the circuits consist of a polycarbonate mouthpiece attached to a co-extruded PVC/PE sampling line. The materials have passed biocompatibility testing for contact durations up to 24 hours. The testing included rigorous tests per ISO 10993 for cytotoxicity, irritation, and sensitization.

Designed to Eliminate Pathogen Exposure

The breathing circuits are compatible with standard hospital aerosol procedures, relevant for infectious disease management.

  • The monitor end of the breathing circuit sample line contains a special PTFE (Polytetrafluoroethylene) membrane filter to protect the monitor from pathogen-containing droplets from patient breath samples. This prevents the re-circulation of pathogens into room air via the monitor’s exhaust system.
  • All joints and sections of the circuits are air-tight and are tested for leakage at a state of the art ISO 13485:2016 facility, heat-sealed in individual packaging, and finally stored at our MDSAP/ISO 13485:2016 facility. US manufactured, assembled, and tested.

Patient-Centric Design

  • Ergonomic design of the patient-side opening reduces leakages of exhaled breathing gases and supports patient comfort and high compliance.
  • The breathing circuit incorporates a handle-connector piece that was engineered specifically to serve multiple functions. It facilitates circuit handling, provides more surface area for sampling tube bonding, creates an air-tight seal, and discourages kinking in the tubing.
  • The sampling line material prevents gas absorption from the gases as they travel from the patient to the MediPines Gas Exchange Monitor to allow for precise and accurate measurements.

Built-In Hydrophobic Membranes

  • The breathing circuit incorporates an enclosed monitor-side filtration system that blocks particulates at a micron level from entering and contaminating the unit.
  • MediPines designed the entire gas pathway from the breathing circuit to the internal sensors with a uniform inner diameter to retain laminar flow and minimize measured waveform distortion
  • The monitor-end connector slides over an annular O-ring to prevent gas leakage or contamination of the sampled gas.

 

 

Proven Medical Grade Materials

  • Optimized for steady state use with the MediPines Gas Exchange Monitor
  • Incorporates medical grade materials and tubing. MediPines has tested the materials extensively through cytotoxicity, sensitization, and irritation studies per ISO 10993 to ensure the absence of patient biocompatibility issues.
  • Passed extensive compliance testing to the IEC 60601-1 safety standard and the ISO 80601-2-55 respiratory monitor standard for qualified use with the MediPines Gas Exchange Monitor.

 

 

Designed to Maximize Laminar Flow

  • Using the fluid dynamics principles of flow, the breathing circuit features an inner fluid volume profile to ensure sampling of laminar flow during patient breathing. Laminar flow sampling is crucial for precise measurement of the composition of mixed gases being exhaled and inhaled by the patient.
  • The converging design on the patient side of the mouthpiece prevents mixing with ambient air. The opposite side facilitates rapid displacement of exhaled gases by ambient air during inhalation.
  • The flattened ovular opening on the patient side in combination with the circular distal opening of the breathing circuit have been optimized to allow the patient to breathe comfortably for the entire duration of a measurement session. These dimensions facilitate unrestricted bidirectional flow during a patient’s breathing cycle.
Ergonomic Breathing Circuit