Portable Respiratory Monitoring System
Monitors and detects changes in pulmonary gas exchange in diseased states.
The MediPines AGM100 provides real-time measurements of 12 respiratory metrics by sampling a patient’s normal breathing and can be used to detect respiratory impairments such as those resulting from COVID-19. The device is non-invasive, portable, and displays all respiratory measurements in one output screen.
This product was selected for inclusion in WHO’s 2021 Compendium of Innovative Health Technologies for Low‐Resource Settings.
This product is available from the manufacturer.
Goal 3: Good health and well-being
Any trained healthcare professional with the need for portable respiratory measurements of patients.
Manufactured in the United States
Users can obtain the product directly from the manufacturer.
As of October 2020, between 0-100 units have been distributed.
LEDs, audio alarm w/dB level, etc.
temperature, oxygen saturation, HR, etc.
- PIO₂: Partial Pressure of Inspired Oxygen, mmHg
- PETO₂: End Tidal Partial Pressure of Oxygen, mmHg
- PETCO₂: End Tidal Partial Pressure of Carbon Dioxide, mmHg
- RR: Respiratory Rate, Br/m
- Pleth: Plethsymogram
- SpO₂: Oxygen Saturation, %
- Pulse Rate: Pulse rate
- BPMgPaO₂TM: Calculated Arterial Partial Pressure of Oxygen, mmHg
- O₂ Deficit: Alveolar and Arterial Oxygen Difference (PAO₂-PaO₂), mmHg
- gPaO₂TM/PAO₂: Ratio of Arterial to Alveolar Oxygen Partial Pressure, %
- gPaO₂TM/FiO₂: Ratio of Arterial to Fraction of Inspired Oxygen
- RQ: Respiratory Quotient
While wearing a pulse oximeter and nose clip, the patient breathes normally through a provided breathing circuit. Over the course of the 2-minute test, the monitor will display either real-time breathing gas waveforms or clinical parameters. After the test, the results can be saved or printed. The device is portable and can utilize its internal rechargeable battery when not connected to a direct power source. The backup battery can provide up to 2 hours of power at full charge, and takes 4 hours to fully recharge the battery. The device weighs ~ 1.7 kg.
Provided by the manufacturer.
The oxygen sensor is available on the open market and can also be purchased through MediPines.
0-2 year lifetime, includes a 1-year warranty
The manufacturer specified performance targets include automatic calibration, high accuracy, 1-2 minute reading turnaround, non-invasive, push-button operation, portable, economical, and efficient.
Testing performed by academic institutions found that the device “provided a valid and reliable measure against directly measured arterial blood gasses at rest and during hypoxic exercise“. Another study found that this device is “very sensitive to the presence of disease and may discard the need for arterial punctures in many instances” for patients with lung disease. Additionally, this device has been tested for water ingress/mechanical strength testing, Electrical Safety testing (60601-1-2), and Medical Device Safety Standards Testing (60601-1, 80601-2-55, 80601-2-61).
Testing has been completed by the manufacturer, NEMKO, MECA, University of British Columbia (Canada), Duke University (United States), Bangor University (United Kingdom), and The University of California, San Diego
The device should be operated by a trained individual with appropriate decontamination between use.
SpO2 sensor, MediPines Single Patient Use Breathing Circuit Kit, Noseclip, and power source for charging the battery/use.
Howe, C., et. al, 2020, Validation of a Non-invasive Assessment of Pulmonary Gas Exchange During Exercise in Hypoxia. Chest, Vol. 158(4), pp. 1644-1650.
West J.B., et. al, 2018, A New, Noninvasive Method of Measuring Impaired Pulmonary Gas Exchange in Lung Disease: An Outpatient Study. Chest. Vol. 154(2), pp. 363-369.
AAMI / ANSI ES60601-1:2005/ (R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012
ISO 80601-2-61: 2011
IEC 62304: 2006
This device is evaluated for measuring 12 respiratory metrics.
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