Portable Respiratory Monitoring System

Target Users (Target Impact Group)

Distributors / Implementing Organizations

This product is available from the manufacturer.

Manufacturing/Building Method

Manufactured in the United States

Intellectural Property Type

Patent Protected

User Provision Model

Users can obtain the product directly from the manufacturer.

Distributions to Date Status

As of October 2020, between 0-100 units have been distributed.

Design Specifications

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.

Technical Support

Provided by the manufacturer.

Replacement Components

The oxygen sensor is available on the open market and can also be purchased through MediPines.

Lifecycle

0-2 year lifetime, includes a 1-year warranty

Manufacturer Specified Performance Parameters

The manufacturer specified performance targets include automatic calibration, high accuracy, 1-2 minute reading turnaround, non-invasive, push-button operation, portable, economical, and efficient.

Vetted Performance Status

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).  

Safety

The device should be operated by a trained individual with appropriate decontamination between use.

Complementary Technical Systems

SpO2 sensor, MediPines Single Patient Use Breathing Circuit Kit, Noseclip, and power source for charging the battery/use.

Academic Research and References

Compliance with regulations

AAMI / ANSI ES60601-1:2005/ (R)2012 + A1:2012 + C1:2009/(R)2012 + A2:2010/(R)2012 IEC 60601-1-2:2014 ISO 80601-2-61: 2011 ISO 80601-2-55:2011 IEC 62304: 2006 IEC 60068-2-27:2008 IEC 60068-2-64:2008 ISO 10993-1:2009/(R)2013 ISO 10993-5:2009 ISO 10993-10:2010 ISO 14971:2007

Other Information

None