RFI Attachment 1_ Large CT Tool Kits.pdf

REQUEST FOR INFORMATION

1.0 RFI TITLE: Large CT Tool Kit

2.0 AGENCY: Program Executive Office (PEO) Solider

3.0 OFFICE: Soldier Medical Devices (SMD)

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 Siemen’s computed tomography (CT) maintenance tool kit. This market research may also assist with the further development and/or refinement of the requirements.

6.0 SIEMEN’S PURCHASING: known government distributers – Parts Source

7.0 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.

8.0 DESCRIPTION: PEO Soldier, SMD has a requirement to provide a commercially available, maintenance tool kit for the Sieman’s CT machine which will be used by Army biomedical technicians

(BMETS).

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

10.0 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 Attachment_2 Company & Product Information

11.0 Please note that responses are due no later than 15 days after publishing of the RFI. The preferred method of submission is via email. 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.

12.0 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 1000 AM EST on 28 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

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