RFI Attachment 2 Company and Product Information Surgical Sterilizer.pdf

RFIATTACHMENT2_TEMPLATE_6 MARCH 2020 |

Attachment 2 Company Information

RFI No. W81K04-25-Q-1970

Instructions: Please fill in the information below for each question below.

Questions: Response:

RFI Number Company Name Company Address Point of Contact Phone Number E-mail Address Tax Identification Number (TIN) UEI Number Cage Code

NAICS

Currently registered in SAM.gov Company Web Page Company Location(s) Company is / is not a Small Business Company is / is not SAM Registered Company is / is not ORCA Registered Other Socio-Economic Classifications (e.g. 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program

Respondent has a current Indirect Rate Agreement or a Forward Pricing Rate Agreement

Respondent has an acceptable cost accounting system as defined by DFARS 252.242-7006

OR

Has received a pre-award survey of prospective accounting system (SF 1408)

NOTE: 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 supportability and maintainability of the medical device.

Product Support Elements

Supply Support Parts and Supplies

Is your company familiar with the Defence Logistics Agency (DLA) electronic catalog (E-CAT)?

- 2 -

(reference:

http://www.dla.mil/TroopSupport/M edical/ECAT.aspx Is the medical device currently available for purchase via the Defense Logistics Agency’s E-CAT program?

Identify repair parts:

(i.e. Item Name, Part number, Pictures of repair parts, Price, Weight or/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/estimate 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

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

Operator and Maintainer Telephone Support

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

- 3 -components and accessories) in a hardened case (i.e. pelican, hardening case, etc.).

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?

Copyrights License

Do you see any challenges with providing the government limited copyrights for the system’s operator and maintainer manual(s)?

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(s) cover the basic content requirements: (reference MIL-PRF- 32216B)

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.

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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?

(End of Attachment 2 – Company & Product Information)