RFI Attachment 1 CODS centrifuge lab centrifuge.pdf
PDF 128 KB Posted
- Attached to
- RFI-Centrifuge, Lab General
- Solicitation number
- W81K0425Q1967
- Issued by
-
Department of the Army Medical Command
About this file
This is a Critical Operational Device Specification (CODS) attachment to an RFI from the Department of the Army Medical Command for a laboratory centrifuge. The document outlines minimum and desired specifications for the centrifuge, which must be FDA-cleared with 510(k) approval if Class II or FDA-registered if Class I, capable of producing centrifugal force between 1000-2000g, hold at least 12 tubes (3-10mL capacity), and include features like digital display, lid-lock emergency release, and programmable timer and speed controls. The system must support both 110-120 VAC and 220-240 VAC power.
The RFI (W81K0425Q1967) responses are due by January 24, 2025 at 3:00 PM CT to werner.b.martin.civ@health.mil. The centrifuge will be used for blood grouping, cross matching, Coombs test, and cell washing procedures. Additional requirements include compliance with Trade Agreements Act, one-year minimum warranty, hardened reusable transport cases meeting various MIL-STD testing requirements, and provision of both physical and digital user/operator manuals. The NAICS code is 333998, and this is being procured by PEO Soldier, Soldier Medical Devices (SMD) at Fort Detrick, MD.
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Other files
| File | Type | Posted |
|---|---|---|
| RFI Attachment 2 Company Product Information centrifuge lab general.pdf | ||
| RFI Centrifuge Lab General.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
Operational
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 Operability
The system shall be acceptable for use by both healthcare personnel processing blood samples and by personnel in general laboratory settings.
Relative Centrifugal Force
(RCF)
The centrifuge shall be able to produce a centrifugal force (RCF) between 1000- 2000 g.
Desired characteristi c is to be able to produce a centrifugal force (RCF) >2000 g.
4 Tubes Capacity have the capability of holding at least twelve (12) tubes at the same time
5 Rotor Capacity have a rotor fitting of 3mL – 10mL tubes, with or without spacers/adapters.
c of a rotor fitting 0.5mL
– 15mL tubes, with or without spacers/ada pters
6 Rotor Type have a fixed angle or swing bucket type of rotor.
c a system with an interchange able rotor
7 Lid Attributes have a lid with a lid-lock emergency release function.
cs a lid with a lid-lock emergency release function, and a lid-lock/unlock visual and/or audial indicator(s).
8 Display have a digital display.
9 Run Timer
The centrifuge shall be able to perform a timed run between 1 – 30 minutes.
c of the system is the ability to perform a timed run between 1 – 99 minutes.
10 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.
Minimum
Additionally, if battery charging is necessary, the device must support charging for both
Programma ble Features or Controls have the following programmable features or controls:
- Timer
- Speed (RPM)
Desired characteristi cs of the system in addition to Timer and Speed (RPM), one or more of the following programma ble features or controls:
- Braking modes/spee d
- Repeat previous run parameters
- Save and recall one or more set program(s)
2. Critical Logistic Specifications
Number
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
Desired the contractor for at least (1) year.
This warranty shall include all parts, In- House labor, and technical support during the warranty period 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
Minimum Requirement
N/A
4 Trade Agreements Act (TAA) Compliance
The system shall be compliant with TAA regulations.
5 Harden Reusable Transport Case
A.) The system and all accessories should be securely contained in harden reusable transport cases (e.g. Hardigg, Pelican, ECS Case or Equivalent).
B.) The system should be designed to withstand MILSTD testing in accordance with (IAW) the following paragraphs:
501.7 High Temperature
502.7 Low Temperature
507.6 Humidity
511.7 Explosive Atmosphere
514.8 Vibration
516.8 Shock
517.3 Pyroshock
528.1 Mechanical Vibrations
of Shipboard Equipment (Type I- Environmental and Type II- Internally Excited)
(End of CODS)
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