RFI Attachment1_ CODS_ OGFP (1).pdf
PDF 158 KB Posted
- Attached to
- RFI-Oxygen Generator Field Portable
- Solicitation number
- W81K0425Q8921
- Issued by
-
Department of the Army Medical Command
About this file
This is a Critical Operational Device Specification (CODS) document outlining the minimum and desired requirements for an Oxygen Generator Field Portable (OGFP) device for the Department of the Army Medical Command.
The specifications detail critical operational requirements including: FDA clearance/registration for human use, oxygen generation capability of USP 93±3% (with 99% desired), maximum weight not exceeding 19.5 lbs (with 13 lbs desired), power requirements of 110/220 VAC or 10-20VDC, rechargeable battery backup for 30 minutes minimum (1 hour desired), and airworthiness release for Army rotary wing aircraft. Maintenance requirements specify 360 hours mean time between operational failures (540 desired) and 95% operational availability over 30 days (98% desired). Additional logistics requirements include comprehensive repair parts support, reusable hardened transport case, minimum 1-year warranty (3 years desired), physical and digital manuals, and Trade Agreements Act compliance. All equipment must be new from OEM-authorized dealers.
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| File | Type | Posted |
|---|---|---|
| RFI _OGFP (1).pdf | ||
| RFI Attachment 2_ Company and Product Information_OGFP.pdf |
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Text version
Attachment 1
Critical Operational Device Specification (CODS)
Critical Specifications: The below are critical specifications and the minimum must be met in order for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.
Instructions: Indicate “yes” or “no” under both minimum and desired columns below. Additional comments may be added.
1. Critical Operational Device Specifications
Number Essential
Characteristic Minimum
Requirement Desired
Characteristics
Meets Minimum
Y/N
Meets Desired
Y/N
Comments
Food and Drug Administration (FDA) Regulatory Oversight
The oxygen generator field portable shall be cleared by the FDA with a 510 (K) approval for human use if it is Class II medical device.
If the system is a Class I medical device, it shall be registered with the
FDA for human use.
Minimum Requirement
N/A
2 Quality of Oxygen The OGFP shall generate oxygen, USP 93+/-3 %
The OGFP can generate oxygen, USP, 99%
3 Weight of Device
The weight of the OGFP will not exceed the weight of a filled “D” oxygen cylinder (i.e. 13 pounds (lbs.)) by more than 50 %.
Desired OGFP weigh the same as filled “D” oxygen cylinder
(i.e., 13 lbs.)
4 Power
The OGFP will operate on 110/220 VAC, 60/50 Hz, or
10-20VDC.
Minimum Requirement
N/A
5 Battery Backup
The OGFP will have a rechargeable battery capable of operating ½ hour if external power is lost. Battery shall
Desired rechargeable battery capable of operating 1 hour if external power is lost. Battery recharge when external power is applied should recharge when external power is applied.
6 Airworthiness Release
Airworthiness release for Army rotary wing, aeromedical evacuation aircraft (UH-60) will be obtained
Desired Airworthiness release for all Services rotary and fixed wing aeromedical evacuation and aircraft and selected vehicles of opportunity will be obtained
7 Maintenance
The mean time between Operational Mission Failure will be at least 360 hours.
The operational availability will be .95 when operated over a 30- day period.
The mean time to repair will be 3 hours
The mean time between Operational Mission Failure will be at least 540 hours.
The operational availability will be .98 when operated over a 30- day period.
The mean time to repair will be 1 hour
2. Critical Logistic Specifications
Number
Operational Characteristic
Minimum Required
Desired Characteristics
Meets
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
N/A each item shall be provided on the list.
The contractor shall provide a full list of special tools needed to do repairs or maintenance.
2 Reuseable Hardened Transport Case
The Contractor shall provide the system with all its components and accessories packaged safely, and securely in one self-contained a reusable hardened transport case (e.g. Hardigg or Pelican) with laser foam cut outs.
The hardened transport case shall have the approved marked data plates. Information will be provided after award.
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
4 Trade Agreements Act (TAA) Compliance
The system shall be compliant with TAA regulations.
3. ADDITIONAL REQUIREMENTS
All equipment, parts, and accessories shall be new from the manufacturer. Used or refurbished equipment, or equipment obtained from a third party shall NOT be accepted. Offeror shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system such that
OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.
| N/A |
| Food and Drug Administration (FDA) Regulatory Oversight |
| Minimum Requirement |
| 1 |
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