RFI Attachment 1_ CODS _Mixer Laboratory.pdf
PDF 127 KB Posted
- Attached to
- RFI-Laboratory Mixer
- Solicitation number
- W81K0425Q1963
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Critical Operational Device Specification (CODS) for a laboratory mixer required by the Program Executive Office (PEO) Soldier, Soldier Medical Devices (SMD). The specifications detail both minimum and desired requirements for a device that maintains uniform solution suspension of specimen tube samples through rocking or rotating motion.
Key technical requirements include: FDA clearance as Class I or II medical device, ability to mix at least 10 samples simultaneously (desired: 18 samples), support for 7mm sample tubes, operation at 20 RPM ±1 (desired: adjustable 20-100 RPM), dual voltage capability (110-120VAC/60Hz and 220-240VAC/50Hz) with auto-detection, and manual timer controls. The device must meet MIL-STD testing requirements for environmental conditions including temperature, humidity, shock, and vibration. Logistical requirements include a minimum 1-year warranty (desired: 3 years), physical and digital manuals, TAA compliance, hardened reusable transport cases, and comprehensive repair parts support with documentation of high-failure components.
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| File | Type | Posted |
|---|---|---|
| RFI Attachment 2 Company Product Information Lab Mixer.pdf | ||
| RFI Labortory Mixer.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 Minim um Y/N?
Meets Desired
Y/N? Comments
Food and Drug Administration (FDA) Regulatory Oversight
The Sink Unit Scrub 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 Mixer Tape
The system shall be able to maintain the uniform solution suspension of specimen tube samples by utilizing one of the following motion types:
- Rocking
- Rotating
Minimum Requirement
N/A
3 Counter Surface Tilt Angle
The mixer shall be able to accommodate a counter surface tilt angle of at least 3 percent degrees.
4 Revolutions Per Minute
(RPM)
The mixer shall support up to 20 RPM plus or minus one.
Desired characteristic of the mixer can be adjustable from 20 RPMs to 100 RPMs.
5 Sample Capacity
The mixer shall be able to hold 7mm sample tubes.
6 Number of Samples
The mixer shall be able to mix at least 10 samples at one time.
The mixer can mix at least 18 samples at one time.
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
Mixing Timer
The mixer should be able to be set for a specific time through manual controls on the device itself.
2. 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
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 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
Minimum
(Type I- Environmental and Type II- Internally Excited)
3. ADDITIONAL PERFORMANCE PARAMETERS
These are desired Additional Performance Parameters (APPs) but are not essential.
Additional Performance Parameters
(APPs) Minimum Requirement
Meets Minium Requirements
1 Additional Battery The system will come with an extra battery.
(End of CODS)
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