RFI-XRAY-Calibration-PANMRA-20-P-0000-002995-Attachment-2.pdf

Attachment 1 – RFI TMDE X-ray Calibrator Set

Fill in columns under green highlight, “Vendor Provides”. (Any comments or clarifications are optional.)

TMDE X-Ray Calibrator Set Requirements Matrix

Edging Machine Ophthalmic Lens Vendor Provides

Characteristic Threshold Note degree to which each parameter is met

Comments or clarifications *

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):

2. Current

Measurement

The system shall be able to measure current in radiographic systems in the following parameters:

- mA (milliAmpere)

- mAs (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?

4. Mammography

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?

TMDE X-Ray Calibrator Set Requirements Matrix

Edging Machine Ophthalmic Lens Vendor Provides

Characteristic Threshold Note degree to which each parameter is met

Comments or clarifications *

5. Computed

Tomography (CT)

Measurement

The system shall be able to measure the performance of Computer Tomography

(CT) devices by the following parameters:

- Dose

- Dose Length Product

- Dose Rate

Does device measure Dose, Dose Length Product, and Dose

Rate for CTs?

6. Survey

The system shall be able to measure leakage and scatter resulting from diagnostic X-Ray devices in the following parameters:

- 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?

7. Light

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

Describe how the device performs light measurement:

8. Display 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?

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 110/220 VAC, 50/60 Hz 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:

Characteristic Threshold Note degree to which each parameter is met

Comments or clarifications *

12. System

Sustainment

Resources

Vendor shall provide access to all resources necessary to allow the

Army to sustain the system at the Tracy and

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:

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 indicate your understanding of this requirement:

14. Weight

The system with all accessories and cases for transport should be no more than 15lbs.

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 measure all data with no greater than a 5% error margin.

Does the device measurements fall within the accuracy range?

17. Precision demonstrate repeatability of measurements with no greater than a 2% error margin.

Does the device measurements fall within the precision range?

Characteristic Threshold Note degree to which each parameter is met

Comments or clarifications *

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

System shall display, print, store or export the readings from the current test being conducted.

Describe internal memory capability

20. Stand-By

Charge

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

Describe charging capability

21. Calibration

Frequency

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

List out calibration requirements and frequency

22. Calibration

Certification

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

Please indicate your requirement

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

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

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 indicate your

* Please use this column to provide any clarifications or additional information we should consider in evaluating your offering.

Additionally, please answer the following questions:

1. Electronic Storage: Is job information stored electronically on the unit? If yes, are job details user selectable?

2. Updates: Will electronics or software require periodic update? If yes, what frequency is expected, and what is the method for updates?

3. Customer Support: Is technical support available 24/7? If no, what is availability?

4. Production lead-time: What is vendor’s typical production lead-time, and any min/max order constraints?

5. Risk Management Framework: Does this system have or been submitted for an Authority to

Operate on DOD computer systems?

6. Training: What training is offered or can be offered by vendor (e.g. train-the-trainer, within

USA, outside of USA, maintainer versus operator)?