Attachment 1_Equipment Maintenance Database.pdf

REQUEST FOR INFORMATION

1.0 RFI TITLE: Subscription for Equipment Maintenance Database, Associated Support and Services

2.0 AGENCY: Army Contracting Command (ACC)/ Aberdeen Proving Ground (APG), NATICK

3.0 OFFICE: Solider Medical Devices (SMD) Program Management Office (PMO)

4.0 LOCATION: Frederick, Maryland

5.0 SUBJECT: The Government is conducting market research to determine whether a commercial solution can be provided to meet requirements for a subscription for equipment maintenance database, associated support and services. This market research may also assist with the further development and/or refinement of the requirements.

6.0 DISCLAIMER: This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

• This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI.

• Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders.

• Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information request.

• All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly.

• Responses to the RFI will not be returned.

• At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

7.0 DESCRIPTION: PEO Solder’s SMD PMO has a requirement to provide a commercially available, subscription for equipment maintenance database portable benchtop centrifuge used by veterinarians and animal care specialists during the diagnosis and care of sick and wounded animals. This centrifuge will be provided to Role of Care 1 &2.

8.0 SUBMISSION INSTRUCTIONS: Responses from all capable and qualified sources are encouraged to respond to this request.

9.0 White papers should adhere to the following formatting and outline instructions:

• All submissions shall be made electronically and be in one of the following formats: Microsoft

Word or Adobe PDF.

• Cover Page (1page) o Title o Organization o Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses) o Topic area(s) addressed

• Specifications o Complete the below table for Logistics and Integrated Product Support o Complete the below table for ECs

10.0 Please note that responses are due no later than 15 days after publishing of RFI. The preferred method of submission is via email. The point of contact for this action is ACC-APG Natick Division.

Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. Currently, no solicitation exists; therefore, please do not request a copy of the solicitation.

NO PHONE CALLS PLEASE. It is the responsibility of any potential Offeror to monitor this site for the release of any solicitation or synopsis.

11.0 SUBMISSION CONTACT INFORMATION: Interested entities shall forward submissions to

Trisha R. Scott at trisha.r.scott.civ@army.mil and Patrick Wallace at Patrick.j.wallace3.civ@army.mil no later than 10:00 AM EST on 25 July 2025. Telephonic communication will not be considered as submission nor receive response.

mailto:trisha.r.scott.civ@army.mil mailto:Patrick.j.wallace3.civ@army.mil

Logistics and Integrated Product Support

Logistics and Integrated Product Support: This information is required to develop and execute successful sustainment strategies to areas of desired support, including logistics, maintenance, training, parts, technical data and others which allow for the sustainment of the medical device during storage, transport, setup and use.

All medical devices will be operated and maintained in an austere environment. Maintenance will be supported by Army Biomedical Equipment Specialist. The following requirements help determine best value, supportability, and maintainability of the medical device. (NOTE: Answer can be provided on a second sheet, if required.)

Instructions: This will need to be completed by the vendor. Additional questions may be added to the document by inserting a new row to the table.

Required Information Vendor Response

Product Support Elements

Supply Support Parts and Supplies Is your company familiar with the DLA E-CAT program? DLA in general?

http://www.dla.mil/TroopSupport/Medical/ECAT.aspx

Is the proposed system (etc.) currently available via the Defense Logistics Agency’s E-CAT program?

Identify repair parts by (Item Name, Part number, Pictures of repair parts, Price, Weight and Shipping dimension of each repair part)

Identify any repair part kits.

Identify the Means Time To Repair (MTTR) and Means Time Between Failure (MTBF) for the device and identify the associated repair parts. This will allow DoD to plan and budget to sustain the device within the US Army.

Identify the amount of time to perform repairs, calibration, electrical safety and preventive maintenance for this product.

Maintenance Planning and Management Maintenance Concept

Identify your maintenance strategy to support this device (i.e., operator and technician level maintenance; schedule maintenance requirement -annually, semi-annually, or quarterly).

Maintenance Agreement

Is there any type of maintenance agreements/service contracts available for this device?

Operator and Maintainer Telephone Support

Is there operator (applications) and maintainer (technical) telephonic support for the proposed system?

Alerts, Recalls and Field Change Order Notifications

How does the OEM notify and-or address Alerts, Recalls and Field Change Order Notifications for the proposed system?

Level of Repair Analysis (LORA)

Provide Level of Repair Analysis (LORA) for the device.

Packaging, Handling, Storage and Transportation Storage Identify Hi/Low Storage temperatures, operating temperatures, and humidity.

Packaging Identify challenges in packaging your device (configuration, all components and accessories) in a hardened case (i.e. pelican, hardening case, etc.).

http://www.dla.mil/TroopSupport/Medical/ECAT.aspx

Transport Case Labeling

Identify any challenges in labeling each case with a National Stock Number(s) and Item Unique Identification (IUID)

Technical Data (Refers to all operator and maintainer manuals, schematics, drawings, etc. related to the operation and maintenance of the proposed device?

Technical Data Accessibility

Do you see any challenges with providing limited copy rights for the system’s operator and maintainer manual?

Operator and Service Manual

The manufacturer will receive a Copyright release form.

This form will be provided by the Government.

Service Manual and Operator Format

Does your operator and maintainer manual cover, (based on MIL-PRF-32216A) the basic content requirements:

a. Cover or title page, table of contents, and safety precautions.

b. Introduction.

c. Preparation for use and installation.

d. Theory of Operation (Principles of operation).

e. Operating instructions.

f. Maintenance and servicing instructions (preventive and corrective).

g. Reprogramming.

h. Preparation for shipment.

i. Storage.

j. Parts list.

k. Operational and maintenance illustrations.

l. Overhaul instructions (as applicable).

m. schematics

Support Equipment Specialized tools and-or performance testing equipment

Identify any proprietary support equipment or tools to operate/maintain to support the device, if any.

Training and Training Support Clinical Applications and Maintainer Training Plan

Identify any operator and maintainer training, and training support plan (strategy) for your device.

On-line Maintainer and Operator Sustainment Training

Identify if there are any On-line Maintainer (Maintenance Support) and Operator (Clinical and software) Sustainment Training resources for your device.

Training Videos Identify if there are any training videos that allow for the operation and maintenance (support: repairs and preventive maintenance).

Facilities and Infrastructure Power Requirements

AC or DC Volts Amps Watts Hertz Battery Type Battery Charge Time, minutes Battery Size, Inches (H x W x L)

Battery Weight, lbs./kg Computer Resources and Design Interface Operating System

Identify your operating system, if any.

Application Software

Identify application software for your device.

DoD Risk Management Framework (RMF) and Cybersecurity Testing Requirement

Does your system have an Authorization to Operate (ATO) within the DoD Network?

ESSENTIAL CHARACTERISTICS: These characteristics are essential and must be met in order for the device to be considered acceptable. They may be subdivided into a threshold (T) and an objective (O). The threshold (T) is the minimum acceptable value while the objective is a desired level of performance above the threshold.

Instructions: This will need to be completed by the vendor. Additional questions may be added to the document by inserting a new row to the table.

Number Essential

Characteristic (EC) Minimum Required

Desired Characteristics

Meets Threshold

Y/N?

Meets Objective

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

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 be able to accommodate no fewer than six tube samples simultaneously.

f

The Centrifuge shall be able to accommodate no fewer than 12 tube samples simultaneously.

5 Angle be 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 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 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.

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 endure transport shock, drop, and vibration. The case shall meet military standard MIL- STD810H(1), see standard 501.7 and be certified

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