Minimum Technical Requirements.pdf

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6515--Anesthesia Units Extend due date/time
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36C24125R0116
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This document is a Minimum Technical Requirements (MTR) catalog for Anesthesia Units – Non Expendable Equipment. The document outlines nine specific technical requirements for anesthesia units, focusing on safety, functionality, and technical compatibility. Key requirements include FDA clearance, safety systems for gas connections, hypoxic mixture prevention, ventilation modes supporting CPAP, precise respiratory control parameters, monitor capabilities, and system interface compatibility with VA health records systems. The MTRs specify technical specifications such as respirator frequency range (3-100 breaths per minute), ventilator inspiratory gas flow range (1-180 L/min), and the ability to have severable unit packages for flexible purchasing of components including freight, warranty, and technical support.

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36C24125R0116_4.docx DOCX document
36C24125R0116_3.docx DOCX document
36C24125R0116 Amend 0002.pdf PDF
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Anesthesia Units – Non Expendable Equipment Catalog

Minimum Technical Requirements

MTR 1 – The anesthesia units must be cleared by the Food & Drug Administration

(FDA).

MTR 2 – The anesthesia units’ pipeline connections must have a diameter-indexed safety system (DISS) or other equivalent means to prevent connection of dangerous gasses.

MTR 3 – The anesthesia units must have a hypoxic mixture fail-safe system control to prevent the unit from being set to dispense a hypoxic mixture. The N20 and O2 flow must be interlocked in ratio proportions with a minimum value of 25% to produce a breathing mixture.

MTR 4 – The anesthesia units’ ventilation modes should support continuous positive airway pressure (CPAP) volume and pressure control.

MTR 5 – The anesthesia units’ respirator frequency must be able to be set within a range of 3-100 breaths per minute.

MTR 6 – The anesthesia unit’s ventilator inspiratory gas flow range must be between 1-180 L/min.

MTR 7 – The anesthesia unit’s monitors must include a continuing pressure alarm capable of sensing high gas pressure and include minimum selectable threshold levels in the patient’s breathing circuit.

MTR 8 – The anesthesia units must be able to interface with VA VISTA, CPRC, CERNER, and anesthesia health records keeping systems.

MTR 9 – The anesthesia unit packages must be severable such that separately priced items can be purchased to complete bundles (to include freight, warranty, and technical support).

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