Requirements Document_Critical Operational Device Specifications.docx
DOCX document 42 KB Posted
- Attached to
- Centrifuge
- Solicitation number
- W81K0425Q2725
- Issued by
-
Department of the Army Medical Command
About this file
This Requirements Document outlines the specifications for a military centrifuge procurement by Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices. The government plans to award a full and open contract for two different centrifuge models, initially purchasing six units (three of each model) for operational and environmental testing. The requirement stems from the discontinuation of the current Becton Dickinson Triac Centrifuge, with the Army seeking to maintain service capability for veterinary and medical sample processing.
The document details critical operational device specifications, including FDA regulatory requirements, core functionality for processing biological samples, and specific technical parameters. Key specifications include compatibility with microhematocrit and various tube sizes, ability to process at least six simultaneous tube samples, and a relative centrifugal force range from 300g to over 10,000g. The government's long-term intent is to procure an estimated 129 centrifuges over five years, with the goal of integrating the device into the Defense Logistics Agency's Electronic Catalogue (ECAT) to facilitate easy procurement for military users.
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| File | Type | Posted |
|---|---|---|
| A02 WK8104Q2725-Veterinary-Centrifuge.pdf | ||
| _Centrifuge -EBOM.xlsx | XLSX spreadsheet |
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Requirements Document: Critical Operational Device Specifications (CODS) / Additional Performance Parameters (APP) Title: Centrifuge
Requiring Activity/Agency Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD)
Purpose: The government anticipates awarding a full and open contract for two different centrifuge models. The government will procure three units of each model for a total of six units. These centrifuges will undergo operational testing conducted by the Medical Test and Evaluation Activity (MTEAC) and environmental testing conducted by the US Army Medical Research and Development Command (MRDC), in accordance with Military Standard 810-H (Mil-STD-810H).
Background: The current device is a Becton Dickinson (BD) Triac Centrifuge, a portable bench top unit used by veterinarians to separate plasma/serum from blood collection tubes and urine sedimentation, for direct reading microhematocrit determinations, and for the diagnosis and care of military-owned animals. The current BD centrifuge and OEM parts are no longer procurable as the manufacturer has discontinued the item in 2019. As a result, the Army is updating this device to maintain service ability.
Government Intent: After successfully completing operational and environmental testing, in FY27 the government intends to procure an estimated 129 centrifuges for up to 5 years. To easily get the centrifuges to the warfighter, it is the government’s wish that the awarded vendor works with the Defense Logistics Agency (DLA) to have the device added to Electronic Catalogue (ECAT).
The Defense Logistics Agency (DLA) Electronic Catalog (ECAT) is a crucial online system used by the Department of Defense and government agencies to procure supplies and equipment. Acting as a centralized online store, ECAT provides access to millions of National Stock Numbers (NSNs) with detailed product information, including descriptions, pricing, and availability. This system streamlines the procurement process, allowing users to easily search for items, place orders, and track shipments, ultimately saving time and money while ensuring all branches have access to the same standardized products. Please access how to do business with ECAT @ https://www.dla.mil/Troop-Support/Medical/ECAT/, for specific questions, recommend contacting the ECAT Help Desk @ dscpecathelp@dla.mil.
1.Critical Operational Device Specifications (CODS): The below are essential characteristics and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
| # |
| Operational Characteristic |
| Minimum Required |
| Desired Characteristics |
| 1 |
| 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
| 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. |
| Minimum Requirement |
| 3 |
| 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 |
| The Centrifuge shall be 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 |
| The Centrifuge shall be of a fixed-angle design. |
| The Centrifuge shall be of a swinging-head design. |
| 6 |
| Relative Centrifugal Force (RCF) |
| The Centrifuge shall support an RCF range from 300 Gravity-Force (g) to greater than 10,000 g. (RCF should be 300 g to <10,000 g) |
| Minimum Requirement |
| 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/RCF modes
• Lid with emergency release
| 8 |
| Power |
| The Centrifuge shall be 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. |
| 9 |
| 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. |
| Minimum Requirement |
| 10 |
| System only weight |
| The vendor shall provide a centrifuge that weighs no more than 50lbs. |
| The centrifuge weighs 25lbs or less. |
| 11 |
| Motor |
| The Centrifuge shall have a brushless motor. |
| Minimum Requirement |
2. Critical Logistical Specifications The below are essential logistical characteristics and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
| # |
| Logistical Characteristic |
| Minimum Required |
| Desired Characteristics |
| 1 |
| Trade Agreements Act (TAA) Compliance |
| The Centrifuge and repair parts shall be compliant with TAA regulations. |
The vendor must complete the attached TAA compliant sheet (see Attachment 1TAA Compliant Verification).
Minimum Requirement
| 2 |
| Repair Parts Support |
| The Vendor 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. |
| Minimum Requirement |
| 3 |
| Maintenance Requirement |
| The Centrifuge shall not have any proprietary-scheduled maintenance actions that occur more than once per year. |
| Minimum Requirement |
| 4 |
| Special Tools |
| The Centrifuge shall not require any |
special tools for maintenance actions.
Minimum Requirement
| 5 |
| Manuals |
| The vendor shall provide 1 physical and 1 digital User/Operator manual for each system. |
The vendor shall provide 1 physical and 1 digital Maintenance/Service Manual with each system procured.
Minimum Requirement
| 6 |
| Training |
| The vendor shall provide on-site operator and maintainer training. |
| Minimum Requirement |
| 7 |
| Risk Management Framework (RMF) / Authority to Operate (ATO) |
| If deemed relevant, the vendor shall provide supporting documentation as required by the client to complete Risk Management Framework (RMF) procedures and Authority to Operate (ATO) activities for cybersecurity protections. |
| Minimum Requirement |
| 8 |
| Copyright Release |
| The vendors will provide an operational and maintenance copyright/ distribution release for supporting Army technical manuals to be distributed throughout the force. |
| Minimum Requirement |
| 9 |
| Reusable Hardened Transport Case |
| The centrifuge shall be configured in one or multiple reusable hardened transport cases designed to endure MIL-STD-810H transport shock and drop exposures. |
| The centrifuge shall be configured in one reusable hardened transport case designed to endure MIL-STD-810H transport shock and drop exposures. |
| Storage Temperatures |
| The system shall endure high storage temperatures as high as 60°C, and low storage temperatures as low as -20°C. |
| The system shall endure high storage temperatures as high as 71°C, and low storage temperatures as low as -30°C. |
| Operating Temperatures |
| The system shall remain operational at temperatures as high as 35°C (95°F) and as low as 4°C (40°F). |
| The system shall remain operational at temperatures as high as 40°C (104°F) and as low as 0°C (32°F). |
| Operating Humidity |
| The system shall endure up to 75% humidity during operation. |
| The system shall endure up to 90% humidity during operation. |
| 13 |
| Warranty |
| The vendor must provide a 3-year manufacturer warranty. |
| Vendor provides 5-year manufacturer warranty |
| 14 |
| Packaging |
| The supplier shall provide the Centrifuge with all its components and accessories packed safely and securely in self-contained, hardcases. The cases shall have approved marked data plates with the following information: |
· National Stock Numbers (NSNs); actual NSN(s) to be provided after award.
· Item Unique Identification (IUID) on each system/unit, in accordance with Defense Federal Acquisition Regulation Supplement 252.211-7003, IUID and Valuation, December 2013.
· Shall include a waterproof list of case contents with picture showing location and position of item in the case.
Inserts shall be of protective material capable of sustaining the system throughout transport and environmental conditions.
Minimum Requirement
3. Additional Performance Parameters (APPs): The below are non-essential additional characteristics that the government desired but not required to be deemed acceptable.
| # |
| Additional Performance Parameters |
| Minimum Required |
| 1 |
| Support of Device |
| The vendor can support the device until the next modernization, ~10 years. |
| 2 |
| Defense Logistics Agency, Electronic Catalog (ECAT) |
| The vendor currently has a DLA ECAT contract or is willing work with a Prime Vendor to get centrifuge added to the electronic catalog to provide a process that streamlines the procurement, allowing users to easily search for items, place orders, and track shipments, ultimately saving time and money while ensuring all branches have access to the same standardized products |
4. Delivery Location Attn: Kristyn Rivera / Robert Charnichko Tobyhanna US Army Medical Agency Medical Maintenance Operations Division (MMOD) Tobyhanna Army Depot 11 Hap Arnold Blvd Bldg 7 Bay 1 Tobyhanna, PA 18466-5063
Mrs. Kristyn Rivera
(570) 615-6787 kristyn.s.rivera.civ@army.mil
Mr. Robert Charnichko
(570) 615-5363 robert.l.charnichko.civ@army.mil
5. Delivery Timeframe: 30-60 days after award
File details come from the government source that posted it. Updated .