Attachment 1 CODS Portable Oxygen Systems.pdf
PDF 184 KB Posted
- Attached to
- PORTABLE OXYGEN GENERATOR SYSTEM
- Solicitation number
- W81K0425Q1969
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Critical Operational Device Specification (CODS) for a Portable Oxygen Generator System (POGS) that outlines the minimum and desired requirements for the device. The specifications detail both operational and logistical requirements for a medical-grade oxygen generating system capable of supplying oxygen at 93% ±3% USP concentration at 33 Lpm, while also generating greater than or equal to 30 Lpm of Medical Air at 50 PSI for anesthesia equipment and ventilators.
Key requirements include FDA clearance (510(k) for Class II or registration for Class I devices), dual voltage capability (110-120 VAC and 220-240 VAC), maximum weight of 900 lbs (desired under 700 lbs), four-person portability (desired two-person), and specific monitoring systems for power failure, carbon monoxide, dew point, and purity. The logistical specifications mandate a minimum one-year warranty (desired three years), both physical and digital manuals, TAA compliance, in-person and video training, and packaging in a hardened case. Additional desired performance includes the ability to refill size "D" cylinders within 12 minutes per cylinder.
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| File | Type | Posted |
|---|---|---|
| Attachment 2 Company and Product Information.pdf |
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
1. Critical Specifications: The below are critical specifications and the minimum must be met for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
2. Instructions: Indicate “yes” or “no” under both minimum and desired columns below. Additional comments may be added.
3. Critical Operational Device Specifications
Operational Characteristic Minimum Required
Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Food and Drug Administration (FDA) Regulatory Oversight
The system must be, cleared by the FDA with a 510(k) approval for human use if it is a Class II medical device.
If the system is Class I medical device, it must be registered with the FDA for human use.
Minimum Requirement
N/A
2 Power The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220-240 VAC, 50Hz. It must include auto-detection and simultaneous switching capability between both voltage ranges. Additionally, if battery charging is necessary, the device must support charging for both voltage ranges
Minimum Requirement N/A
3 Oxygen Concentration
The system shall be able to supply oxygen at a concentration of at least 93%+-3% USP
Minimum Requirement
4 Weight The system shall weight no more than 900 lbs The system shall weight less than 700 lbs.
5 Oxygen Demand
The system shall generate 33 Lpm of USP 93%+-3% oxygen.
6 Anesthesia/ Ventilator Unit Compatibility
The system must generate greater than or equal to 30 Lpm of Medical Air to operate anesthesia equipment and ventilators at
50 PSI.
Minimum Requirement N/A
7 Portability The system shall be four-person portable, compact, reliable, completely self-contained
The desired characteristic is a Two-person portable, compact, reliable, completely self-contained
8 Monitors and Alarms The system shall include the following alarms with the ability to silence for noise discipline:
- Power failure
- Carbon Monoxide
- Dew Point Monitor
- Purity
4. Critical Logistic Specifications
Operational Characteristic Minimum Required
Desired Characteristics
Meets Minimum Y/N?
Meets Desired Y/N? Comments
1 Repair Parts
Support
Contractor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.
2 Warranty The contractor shall provide a warranty for at least
(1) year. This warranty shall include all parts, In-
House labor, and technical support during the warranty period
Desired the contractor provides a warranty for at least 3 years.
This warranty shall include all parts, In-house labor, and technical support during the warranty period.
3 Manuals The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system
Trade Agreements Act (TAA) Compliance
The system shall be compliant with TAA regulations.
Minimum Requirement N/A
5 Training The vendor shall provide in person training and video training on the use of the system.
Minimum Requirement N/A
6 Reusable Hardened
Case
The system shall come with packaging (configuration, all components and accessories) in a hardened case (i.e. pelican, hardening case, etc.).
3. ADDITIONAL PERFORMANCE PARAMETERS
These are desired Additional Performance Parameters (APPs) but are not essential.
Number Additional Performance
Parameters (APPs) Minimum Requirement
1 Refilling Cylinders The system must be capable of refilling a size "D" cylinder at a rate of no more than 12 minutes per cylinder.
***End of CODS***
File details come from the government source that posted it. Updated .