A02 Attachment 1 Minimum Essential Characterics.pdf
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- Attached to
- Veterinary Centrifuge
- Solicitation number
- HT9425-24-RFI-Veterinary-Centrifuge
- Issued by
-
Defense Health Agency
About this file
This document is a Request for Information (RFI) for a Veterinary Centrifuge. The RFI outlines the minimum essential characteristics (MEC) for the centrifuge, which must meet requirements such as FDA clearance, compatibility with various tube sizes, a relative centrifugal force range of 650 to 10,500 g, and specific controls and features. The centrifuge must also be compliant with the Trade Agreements Act and come with manuals, a transportation case, and a 1-year warranty.
The government is conducting market research to determine if a commercial solution can meet the requirements for this veterinary centrifuge, which will be provided to Role of Care 1 & 2 units. The RFI is being issued by the Defense Health Agency's Military Field System Program Management Office. Respondents are asked to indicate whether they can meet the minimum and desired characteristics for the centrifuge.
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Text version
Attachment 1
RFI No. HT9425-24-RFI-Veterinary-Centrifuge
MINIMUM ESSENTIAL CHARACTERISTS (MEC)
ESSENTIAL CHARACTERISTICS: The below are essential characteristics 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.
Number
Essential
Characteristic Minimum Required Desired
Characteristics
Meets Minimum
Y/N?
Meets Desired
Y/N? Comments
Food and Drug Administration
(FDA)
Regulatory Oversight
The Centrifuge shall be cleared by the FDA with a 510(k) approval, if it is a 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 Core Function
The Centrifuge shall be able to process biological samples such as blood, urine, and fecal samples. In addition, the Centrifuge shall be able to accommodate microhematocrit determinations.
Tube Size Compatibility
The Centrifuge shall be compatible with microhematocrit, small, 2 to 5 milliliters (mL), and large, 12 to 15 mL, tubes.
The Centrifuge shall be compatible with microhematocrit, small, 0.5 to 5 mL, and large, 12 to 15 mL, tubes.
4 Tube Capacity able to accommodate no fewer than six tube samples simultaneously.
The Centrifuge shall be able to accommodate no fewer than 12 tube samples simultaneously.
5 Angle of a fixed-angle design.
The Centrifuge shall be of a swinging-head design.
Relative Centrifugal Force (RCF)
The Centrifuge shall support a RCF range from 650 Gravity-Force
(g) to, at least, 10,500 g.
The Centrifuge shall support a RCF range from 350 g to greater than 10,500 g.
7 Controls and Features
The Centrifuge shall have the following controls and features:
• Timer
• Varying speeds/RCF modes
• Lid with emergency release
The Centrifuge shall have the following controls and features:
• Brake control
• Timer
• Varying speeds/R CF modes
• Lid with emergency release
Power able to support 110 or 120 Volts Alternating Current (VAC) and 60 Hertz (HZ).
The Centrifuge shall be able to support 110 or 120 VAC, 60Hz, and/or 220-240 VAC, 50Hz, with the ability to auto-detect and auto-switch between the two.
Trade Agreements Act
(TAA)
Compliance
The Centrifuge shall be compliant with TAA regulations.
10 Manuals
The vendor must provide 1 hardcopy and 1 digital User and Operator Service. In addition, 1 service manual must be provided.
11 Transportation Case
The vet centrifuge shall be configured in one or multiple reusable hardened transport cases with protective foam, designed to meet military standard MIL- STD810H (1), see standard.
12 Storage Instruction
Vendor shall provide storage instructions for both short-term (less than 6 months) and long-term (greater than 6 months) storage to include required maintenance before returning to use.
14 Warranty The vendor must provide a 1-year warranty
(end of MEC)
File details come from the government source that posted it. Updated .