Background:
In 1928, Warren E. Collins, Inc., manufactured the first modern iron lung machine. Collins is better known as the maker of respiratory diagnosis instruments. Collins GEM (Gas Exchange Module) Repair is spirometer. The device is available in Europe and North America exclusively as it is hard to locate them overseas. The GEM is intended to function as a non-invasive pulmonary function testing device (PIT) that can be customized for specific applications and indications. It is designed to be used for diagnostic purposes in the treatment of pulmonary disorders. It is recommended for Pulmonary Technicians, Respiratory Therapists for pulmonary testing.
Identification:
The electric device has a glass tower box appearance with Diaphragm assembly which has a balloon valve, cable assembly for external flow and it contains a breathing house for pulmonary flow. The gas analyzers are made up of an electrochemical sensor for measuring fast-response oxygen and a fast-response Infrared analyzer for measuring gases. The model number for the electric device is place on side of it and some manufacturers put it on top so it is easily located.
Technical Specifications:
The electric device runs on battery with power of 115-240 VAC, 50-60 Hz, at 3.15 Amp. It weighs about 18 pounds; 8.2 Kg. Gas operated specification includes Single screen pressure device that describe pulmonary gas flow.
Linearity: 2%
Resistance: 0.5 cm, HaO/L/Sec @ 14 L/Sec
Accuracy: +/- 3%
Flow Range: +/- 15 L/Sec
Source: Center for Devices and Radiological Health. (n.d.). Medical device databases. U.S. Food and Drug Administration. Retrieved January 30, 2023, from https://www.fda.gov/medical-devices/devi...
Additional information:
1. 510(k) SUMMARY Collins Medical, Inc. 's GEM: This source helped me understand the roles of GEM devices and technical specifications and detailed about the usage and predicate devices. Therefore, I learn about the background and technical specifications of the device from this source.
2. Predicate device VMAX Manual: This pdf consists of predicate devices by GEM that helps in pulmonary functions and their manual usage and directions to use them.
3. Respirometer helps in Pulmonary flow: This page is credible as it is from a Museum organization’s page. This source helped me understand the history of Collins devices and respirometers.
4. Combined Nitrogen Washout method: This paper helps me understand the equipment usage in Breath washout and how it helps.