W81XWH20Q0131 _Attachment 1 - Vendor Responses to the Minimum Essential Characteristics.pdf

Vendor Responses to the Minimum Essential Characteristics

The following information, at a minimum, is requested in response to each minimal essential characteristic listed below. Vendors should include additional information to clarify their ability to meet each MEC as well as diagrams, pictures, etc. as required in order for the Government to clearly evaluate the ability of the device to meet or exceed the MECs.

Essential Characteristic Threshold (T) Minimum Requirement Questions

1. Regulatory Approvals Shall meet IEC standards: 61010-1

(1:2010) Testing and Measuring Equipment 61674 (2:2012): Dosimeters with ionization chambers and/or semiconductor detectors as used in X-Ray diagnostic imaging

Does device meets IEC Standards?

Confirm it meets IEC Standard 61010-1(1:2010) declaration.

2. Current Measurement The system shall be able to measure current in radiographic systems in the following parameters:

- mA (milliAmpere-second)

- Pulse

- Pulse Rate

Does device measure mA, mAs, Pulse and Pulse rate?

If not, which one(s) and why?

What other parameters not listed above, if any, does it measure?

3. Radiography/Fluoroscopy (R/F) Measurement

The system shall be able to measure the performance of X-Ray and Fluoroscopic devices by the following parameters:

- kVp (kiloVolt potential)

- HVL (Half-Value Layer)

- Dose

- Dose Rate

- Pulse Rate

Does device measure kVP, HVL, Dose, Dose Rate, and Pulse Rate for R/F?

If not, which one(s) and why?

What other parameters not listed above, if any, does it measure?

4. Mammography Measurement

The system shall be able to measure the performance of Mammographic devices by the following parameters:

- kVp

- HVL

- Dose

- Dose Rate

- Pulse Rate

Does device measure kVP, HVL, Dose, Dose Rate, and Pulse Rate for Mammography?

If not, which one(s) and why?

What other parameters not listed above, if any, does it measure?

5. Computed Tomography (CT) Measurement

The system shall be able to measure the performance of Computed Tomography (CT) devices by the following parameter:

computed tomography dose index (CTDI) using a 100-mm pencil ionization chamber that fits commonly available acrylic CTDI phantoms.

Does device measure dose index?

Explain how.

6. Survey Measurement The system shall be able to measure leakage and scatter resulting from diagnostic X-Ray devices in the following parameters or equivalent:

- H*(10) (Ambient Dose Equivalent)

- H*(10) Rate

- Air Kerma

- Air Kerma Rate

- Mean Energy

Does device measure H*(10), H*(10) Rate, Air Kerma, and Mean Energy?

If not, which one(s) and why?

What other parameters not listed above, if any, does it measure?

7. Light Measurement The system shall be able to perform luminance and illuminance measurements

Describe how the device performs light measurement:

8. Display The system shall be able to display key measurements and waveforms in real time

List what measurements and waveforms are displayed in real time: What other measurements or information is displayed?

9. Rechargeable Battery

The system shall be able to perform all expected calibration functions per device for 8 hours of continuous use on a single charge

How long does the battery last while in use on a single charge? How long does the battery take to recharge? Is the battery hot-swappable? Can the device be charged while plugged in and in operation?

10. Operational Power The system shall be able to operate on A/C power when not charged

Indicate power required:

11. Data Generation The system shall be able to export measurement data

Describe how date is exported and format:

12. Sustainment Vendor shall provide access to all resources necessary to allow the Army to sustain the system at the Tracy and United States Army Medical Materiel Center, Europe (USAMMCE) depots.

Sustainment shall be IAW the vendor's calibration, services, and repair procedures. Such program shall be validated and approved by the vendor.

The vendor shall provide the Original Equipment Manufacturers (OEM) calibration procedures, Standard Operating Procedures (SOPs), and copy of the NIST standards used.

Unit requires the ability of the Services to sustain the system using Service’s personnel globally IAW with OEM requirements. Please indicate your understanding of this requirements and how your program will facilitate/meet this requirement.

13. Field Maintainability Unit will be equipped with tools, supplies, and accessories required for immediate setup and day-to-day operations, to be included in ruggedized case.

Unit requires minimum tools, supplies and accessories as indicated, regardless of your typical shipped configuration.

Please describe what tools are required to maintain and calibrate this equipment including part numbers and cost. Please provide a maintenance plan that clearly describes what maintenance can be performed by Army personnel (users and OEM trained maintainers) and what maintenance needs to be performed by the OEM if applicable.

14. Weight The system with all accessories and ruggedized cases for transport shall be no more than 15 pounds

Provide weight in pounds of the calibrator in carrying case – including accessories: Provide picture of the device, device accessories, and device in case.

15. Cube The system in its active use configuration shall be no larger than 50 cubic inches

Provide measurements of the device in use in inches and diagram if applicable:

16. Accuracy The system shall be able to measure all data with no greater than a 5% error margin

Does the device measurements fall within the accuracy range?

17. Precision The system shall be able to demonstrate repeatability of measurements with no greater than a 2% error margin

Does the device measurements fall within the precision range?

18. Display Quality The system shall be equipped with a legible display that can show the full array of real-time data

Describe what type of lighting is used for the display (LED, etc.)

19. Internal Memory Shall display, print, store or export the readings from the current test being conducted

Describe internal memory capability

20. Stand-By Charge Describe charging capability

The system shall have 48 hours of stand-by power on a single charge

21. Calibration Frequency

The system shall demonstrate a calibration requirement of no more than once in 12 months

List out calibration requirements and frequency. List of any equipment (TMDE) that is required to calibrate the device and a copy of the calibration procedure. Any proprietary equipment that is needed shall be provided as part of the configuration or available for purchase by the Army.

22. Calibration Certification The system shall come packaged with a NIST traceable certificate of calibration

Please indicate your understanding of this requirement and a copy of the certificate.

23. Documentation The system shall come packaged with a hard copy of the operator manual and service manual.

Unit requires manuals as indicated, regardless of your typical shipped configuration. Please indicate your understanding of this requirement:

Please provide an electronic copy of both the service and operator manual with your response.

24. Ruggedized case(s) Ruggedized, reusable transportation and carrying case configured to include device and accessories needed. Additional case for ancillary equipment, if needed for protection during transport

Unit requires ruggedized case(s) as indicated, regardless of your typical shipped configuration. Please indicate your understanding of this requirement:

25. Warranty Contractor will provide a minimum 12 month warranty that includes all parts, software updates, labor, and technical support during the warranty period

Minimum 12 month warranty is required. Please indicated the length and coverages of the warranty be offered as part of the proposal. Provide copy of the warranty. Describe available extended warranty and/or service agreements that are available.

26. Repair Parts and High Failure Rate Accessories

Vendor will provide a list of all repair parts including National Stock Number

Vendor will provide list as well as summary explanation of how high failure rate accessories were identified.

(if applicable), part number, size, weight, picture, country of origin, and cost for all repair parts and consumables.

27. Training Plan

Vendor will provide training plan to include SOP and costs

Vendor shall provide a training plan along with a copy of the syllabus, copy of the course materials, and an example or description of how trainees will be evaluated.