DRAFT SOW CT X-Ray.docx

Statement of Work Computed Tomography (CT) X-Ray Cabinet Fleet Readiness Center Southwest (FRCSW) Coronado, CA

1. SCOPE: Fleet Readiness Center Southwest (FRCSW) requires a Computed Tomography (CT) system. This new capability is necessary to support the inspection of flight components and future additive manufacturing (AM) fabricated aircraft parts and components at the FRCSW maintenance facility on board Naval Air Station (NAS) North Island in California. The contractor shall be responsible for the complete installation of all new equipment, training personnel, rigging, quality assurance, and necessary equipment to provide a turn-key system in shop KF75820, building 250 located at FRCSW North Island, CA.

2. APPLICABLE DOCUMENTS: The documents listed in this section are cited in Sections 3.0, 4.0 and 5.0 of this specification. While every effort has been made to ensure the completeness of this list, document users are cautioned that they must meet all requirements of documents cited in Sections 3.0, 4.0, and 5.0, whether or not they are listed in Section 2. Unless otherwise specified, the documents listed in the solicitation or contract shall be the current edition at time of solicitation.

2.1. Government Documents.

a.) Specifications, Standards, and Instructions. The following specifications, standards and instructions from a part of this document to the extent specified herein.

Code of Federal Regulations (CFR)

21 CFR 1020.40: Performance Standards for Ionizing Radiation Emitting Products: Cabinet X-Ray Systems

29 CFR 1910.1096: Ionizing Radiation Safety Enablement

29 CFR 1910.147: Control of Hazardous Energy (Lockout/Tagout)

29 CFR Subpart S: Electrical Safety-Related Work Practices

29 CFR 1910.212: General Requirements for all machines

29 CFR 1910.1200: Hazardous Material Communication

Department of Defense Instructions (DODI)

DODI 8500.2; Information Assurance (IA) Implementation

DODI 6055.08; Occupational Ionizing Radiation Protection Program

(Applications for copies should be requested at www.esd.whs.mil/DD/DoD-Issuances/) b.) Other Government Documents, Drawing, and Publications The following other Government documents, drawings, and publications form a part of this document to the extent specified herein. Unless otherwise specified, the documents listed in the solicitation or contract shall be the current edition at time of solicitation.

LOCAL DOCUMENTS

FRCSWINST 5104.2L w-CH-1 IONIZING RADIATION SAFETY PROGRAM (Distribution A)

Layout Drawing

Building 250 CT X-Ray Cabinet System Area Layout (Distribution A)

2.2. Non-Government Publications, Specifications, Standards, and Handbooks.

American Society for Testing and Materials (ASTM)

ASTM E2597/E2597M - 22 Standard Practice for Manufacturing Characterization of Digital Detector Array

ASTM E2737-23 Standard Practice for Digital Detector Array Performance Evaluation and Long-Term Stability

ASTM E2339-20 Standard Practice for Digital Imaging and Communication in Nondestructive Evaluation (DICONDE)

(Applications for copies should be addressed to ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428.)

National Fire Protection Association (NFPA)

NFPA 70, National Electrical Code

(Applications for copies should be addressed to the National Fire Protection Association, ATTN: Support Services, 11 Tracy Drive, Avon, MA 02322)

American Society of Mechanical Engineers (ASME)

ASME Y14.5-2018 Dimensioning and Tolerancing

ASME Y14.100 Engineering Drawing Practices

(Applications for copies should be addressed to ASME International Three Park Avenue, New York, NY 10016-5990 or www.asme.org)

International Organization for Standardization

ISO 10303, Industrial automation systems and integration — Product data representation and exchange.

2.3. Order of Precedence. In the event of a conflict between the text of this document and the references cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained

3. REQUIREMENTS: The contractor shall provide and install a complete CT system in the designated space as shown in the Layout Drawing. It is the responsibility of the contractor to get the entire unit or assembled components to the prescribed space and meet all requirements as set below as a complete system.

3.1. System Capabilities: System shall meet all functions described below:

a.) Advanced 2-Dimensional X-Ray inspection b.) 2-Dimensional CT slice visualization c.) CT volume reconstruction for 3-Dimensional inspection d.) 3-Dimensional internal and external surface inspection and visualization e.) Measurement, visualization, and analysis tools f.) X-Ray tube types and configuration shall be a dual-tube configuration consisting of a 225 kV micro-focus & 450kV mini-focus tube.

g.) The system shall have a voltage range of 20 kV – 450kV.

h.) Single-pass acquisition method for elongated objects: The system shall perform automated acquisition for elongated objects that typically do not fit in a single exposure without requiring volume stitching. The object length is only limited by the systems scanning area. This method reduces or eliminates the cone angle artifacts caused by flat, planar features common in non-spiral CT techniques. This method must support continuous scan operation.

i.) Method for expanding imagining field beyond detector panel size to cabinet size: The system shall fully scan a part that is larger than the detector panel. The system shall perform scanning in step and continuous modes while moving the detector to a series of locations to increase the scanned volume without changing the system geometry.

j.) Method of achieving resolution beyond detector panel resolution: The designed motion of the manipulator and the software shall display and analyze scan data utilizing sub-pixel analysis routines. Resolution shall be at least triple the detector’s native resolution. This method must support continuous scan operation.

k.) The system shall export an executable dataset that allows others to view, slice, rotate, window, and manipulate the dataset on a traditional laptop or desktop computer in an analysis-only viewer. The viewer module shall have the equivalent post-processing capabilities of the CT workstation such as slicing and others mentioned above.

l.) The system shall create and analyze moving or changing parts as dynamic time-based data sets. The system shall acquire time-based data in either a continuous or stepped mode. Continuous scan mode refers to repeatedly scanning the part while motion or change is occurring at a speed that is slow relative to the time it takes to complete a full scan. Stepped scanning refers to re-scanning the part multiple times after the part is removed from the CT cabinet, subjected to some condition that will cause motion or change I the part. The system shall generate time sequenced images (video) showing the motion or change in the part resulting from the continuous or stepped scans.

m.) Based on the location of this equipment, including all space required to operate and maintain the system, shall not exceed the following dimensions: 16’ x 9’ x 9.5’ (L x W x H). The space to process data and control the system through a workstation shall be made to operate at a separate space 10 meters away from the cabinet and the workstation shall not exceed the following dimensions: 5’ x 4’ x 7’ (L x W x H).

n.) The offeror shall ensure that the proposed system layout complies with all current Occupational Safety and Health Regulations (OSHA), Food and Drug Administration regulations, and provides adequate means of personal egress all of which is subject to review and approval by the government.

o.) Equipment weight shall not exceed the maximum loading capacity of the existing 6” thick concrete slab in the designated location for this equipment. The contractor/manufacturer shall provide the weight of the equipment as well as a drawing detailing the feet/support system.

p.) The system shall have a dual detector configuration that meets the requirements described in sections 3.6, 3.7, 3.8, and 3.9 below.

q.) The system shall achieve a scan with an effective voxel resolution of 6 μm or better on a part 0.5 inches in diameter while maintaining a geometric sharpness at the detector of less than 200 μm (1 pixel).

r.) The system shall be closed looping and shall conform to all codes and regulations and have interlocks on doors.

s.) The system shall use externally provided compressed air.

t.) The system after delivery and installation shall be turnkey and fully operational and pass all verification tests before releasing to the government.

u.) The system shall perform automatic scan Geometry Corrections v.) The system shall include Process control Software and routine that can verify and validate the system checks prescribed in ASTM E2737-23.

3.2. Designated Location: Designated location is in NAS-North Island, Building 250, in the south side of the building.

3.3. Radiation Shielded Cabinet: Enclosure shall meet or exceed 21 CFR 1020.40 a.) Shielding Location and Performance

1.) Radiation leakage shall not exceed 0.5 mr/hr (milliroentgen per hour) at any point 5 cm away from the outer surface of the enclosure. This applies to all outer surfaces of the enclosure.

2.) Primary radiation shielding shall reduce the energy of the maximum kVp (Kilovolt Potential) constant attainable by system to the leakage requirement described above and below for all surfaces exposed to the primary beam.

3.) Secondary shielding for all other surfaces shall reduce back scatter and stray radiation to the leakage requirement described above under any operating conditions.

4.) The supplied equipment and all ancillary items necessary to meet the requirements set in this document shall fit in the space prescribed in Layout Drawing.

5.) The equipment shall be fully operational with all capabilities unimpeded by the ancillary items within the space described.

6.) The equipment shall be fully functional including:

i.) All operations/functions shall be accessible and within reach of the equipment operator without shifting from an initial position or having to bend or twist awkwardly.

ii.) Access shall not be restricted to any point below operational envelope/capability.

7.) Equipment shall be fully maintainable. All maintenance points specified in the OEM Maintenance Manual shall be accessible without safety hazards such as pinch points, sharp edges, falls from height (greater than 4 feet), or clearances that create interference for the hand and/or tools/equipment required to perform the maintenance task.

8.) Equipment provided shall be equipped with an automated door to workspace.

9.) The portal shall be fully accessible and designed to handle a part the full size and weight of the work envelope/table/space provided.

10.) All doors shall be equipped with primary and secondary safety interlocks with all supplied X-Ray generation equipment.

11.) Equipment shall be supplied with a warning lamp indicating X-Rays are being generated and labeled.

12.) The warning lamp shall illuminate when X-Ray generation is initiated and remain on until X-Rays have stopped.

13.) The warning lamp shall include backlit lettering ‘X-RAY ON’.

14.) The warning lamp shall be ‘fail-safe’ and not allow X-Ray generation if the bulb is not illuminated for any reason.

15.) The cabinet shall have a tag or label certifying that the cabinet X-Ray conforms to 21 CFR 1020.40.

16.) Equipment shall include cameras for observation of parts inside the cabinet. These cameras shall be provided in sufficient number at field of view and resolution to observe process and diagnose any issues with operation of the unit.

3.4. Object Placement and Control

a.) A flat, level surface shall be provided for placement of objects to be inspected. Surface shall be provided with sufficient details to hold part fixtures securely in place during inspection – some examples would be tee slots or holes. These details shall be sub-flush to flat, level surface provided – no permanent or semi-permanent detail shall be proud of the surface.

b.) For purposes of describing motion control, components in this section shall be referred to as the ‘Part’ in the remainder of this document.

3.5. Environmental Control and Operation Environment

a.) The system shall contain any necessary climate (temperature/humidity) controls required to ensure reliable/repeatable measurements. The vendor shall specify any facility requirements that must be supplied by the customer (power, ventilation, foundation, pneumatic) for proper installation of the proposed system. This system will be placed in an environmentally controlled location.

b.) The system shall have the capability of operating in a temperature of 68°F to 85°F and a maximum atmospheric relative humidity of 60%.

c.) The system shall be designed to be stored in an environment of 0°F to 100°F and a maximum of 80% non-condensing relative humidity without degrading system capabilities.

3.6. Motion Control

a.) The system shall have manipulator with at least 6-axis that utilizes motorized drives to control all axis’s independently at variable speeds and is tethered to the desktop control console.

1.) The inspection envelope is defined as the volume required to physically fit a part for 2-D inspection. The inspection envelope of the supplied equipment shall have the following MINIMUM dimensions:

i.) 30 inches in diameter.

ii.) 45 inches in height.

iii.) 400 pounds weight.

2.) The scan envelope is defined as the volume required to perform a complete CT scan. The scan envelope of the equipment supplied shall have the following MINIMUM dimensions:

i.) 30 inches in diameter.

ii.) 45 inches in height.

iii.) 400 pounds weight.

3.) The part manipulator shall have an X-axis (front-to-back) translation of 32” and Z-axis / focal distance tube to detector translation of 48”

4.) All motion axes shall have resolution as described below.

i.) 0.001 inches for translational axes.

ii.) 0.001 degrees for rotational axes.

b.) Devices Included in Motion Control 1.) For purposes of describing motion control, components listed in this section shall be referred to as ‘Device’ or ‘Devices’ in the remainder of this document.

i.) Digital Detector Array (DDA) as described in Section 3.8 below.

ii.) 225 kV X-Ray ionizing tube as described in Section 3.7 below.

iii.) 450 kV X-Ray ionizing tube as described in Section 3.7 below.

iv.) Part Manipulator as described in Section 3.9 below.

v.) Detector Manipulator as described in Section 3.10 below.

c.) Part Views 1.) The base view shall be with the surface provided as described in Section 3.4 above parallel to the ground/floor. The part shall also be viewed continuously through revolutions of 360 degrees about a vertical axis through the center of the part envelope.

2.) The base view shall have to ability to be tilted on an axis transverse to the X-Ray/detection path a minimum of 20 degrees in either direction. This view shall not inhibit the function in the base view in any way.

d.) Motion Limits 1.) Motion shall meet the following requirements at a minimum:

i.) Acquire an image of the edge/limit/boundary of a part that maximizes the envelope as described above. The system shall be display the image of the edge/limit/boundary of the part with at least 1 inch visible outside/beyond the edge/limit/boundary in the field of view at all possible settings and combinations of settings are described distance from source to part and distance from source to detector.

ii.) In addition to axis/axes required to adjust distance from source to detector, system shall have capability of translating the detector transverse to the source-to-detector path in both horizontal and vertical directions with sufficient range to adjust effective pixel-pitch during image acquisition (Sub-Pixel).

3.7. X-ray Source

a.) 225 kV Open microfocus ionizing tube minimum requirements 1.) Tube voltage 225 kV

2.) Minimum of reaching a throughput power of 320 Watts

3.) Detail Recognition < 4 microns

4.) Obtain a minimum variable focal spot size of 3 μm

5.) Obtain a minimum Focus Object Distance of less than 6 mm

6.) Closed Loop Liquid Cooling 100% duty cycle at 100% power

7.) Oil free vacuum system

8.) High Tension Cable Length to support safety / 100% motion

9.) The system shall be an open tube design.

10.) Complete Control Unit i.) Automatic tube warm-up routine including high voltage, filament current ii.) Automatic focus, electron beam alignment, and target loading control b.) 450 kV X-Ray ionizing tube minimum requirements 1.) Tube voltage 450 kV

2.) Minimum of reaching a throughput power of 1800 Watts for dense materials

3.) Target angle: 11 degrees

4.) Radiation coverage: 40 degrees x 30 degrees

5.) Obtain a minimum of 400 μm and 1000 μm focal spot size

6.) High tension cables of sufficient length to support full function safely c.) X-Ray Control Unit 1.) Windows Based

2.) Automatic Tube Warm up routine including high voltage, filament current

3.) Automatic focus

4.) Electron beam alignment

5.) Target loading control

3.8. Digital Detector Array (DDA)

a.) DDA shall be delivered with objective evidence that it meets or exceeds all qualifications for ASTM E2597-22 with the following specifications:

1.) Size: 17” x 17”

2.) Pixel Pitch 150 μm

3.) Bit Depth: 16 bit

4.) Array size 2048 x 2048

5.) Dynamic range 16-bit (65,536 level grey scale)

6.) Acquisition speed of 15 frames per second (fps) at full resolution

7.) Virtual Detector size 46” x 39”

8.) Shielded housing shall protect the DDA from energy when the unit is run to full power

9.) Minimum Spatial Resolution (SRb) of 0.2mm or smaller measure per ASTM E2597-22

3.9 Part Manipulator shall have the following minimum requirements:

a.) X-axis (front-to-back) translation: 32” b.) Z-axis (focal distance tube to detector translation): 48” c.) Title: +20 / -20 Degrees d.) Stage: 360 Degrees with 0.001 Degree resolution e.) Static Capacity: 400lbs (not including tilt)

3.10 Detector Manipulator shall have the following minimum requirements:

a.) Focal Distance: 0 – 48” b.) Detector and tube Vertical Axis: 48”

3.11 Electrical Power Limit Requirements

a.) The system shall operate with available power as listed below due to facility constraints and will be compliant with NFPA 70, National Electrical Code (the system need not use all these options, this is what will be available):

b.) 240 VAC 1PH/PE c.) 110 VAC 1PH d.) Voltage Fluctuations: +6% to -10% e.) Frequency: 50/60 Hz f.) Max Nominal power: 15 kW g.) Current consumption (max): 50 A

3.12 Workstations:

a.) The delivered workstations shall fit in the prescribed areas. The reconstruction workstation shall fit in the area described in Layout Drawing. The image analysis workstation shall be placed once of the office spaces used by the operators for them to analyze the scans. All workstations shall be modular so that they can be positioned in a way that allows all peripheral hardware to easily be accessed and fit in their respective prescribed areas and shall allow all CT scanning activities to be conducted without moving the workstation. Both workstations shall be ergonomic friendly for the operator. The workstations control console shall include the following:

b.) Image Analysis workstation:

1.) OS: Windows 11

2.) Processor: Six Core Processor (at minimum)

3.) 64GB DDR5 RAM (at minimum)

4.) Hard Drive: 3 TB Hard Drive (at minimum)

5.) Disk Drive: DVD +/- RW

6.) Interface: 10/100/1000 Network

7.) High resolution monitor, keyboard, and mouse c.) CT Reconstruction workstation:

1.) OS: Windows 11

2.) Processor: 24 Core Processor (at minimum)

3.) RAM: 1 TB (at minimum)

4.) Hard Drive: 24 TB Hard Drive with High-Speed Raid 5 capabilities (at minimum)

5.) Disk Drive: DVD +/- RW

6.) GPU: 4 GPU NVIDIA Supercomputer, including at minimum:

i.) 80 GB of GPU Memory ii.) 3D Rendering capabilities iii.) High resolution monitor, keyboard, and mouse

3.13 Software

a.) Supporting Software is all software needed to set up, scan, analyze and visualize data. The supporting software shall include all drivers and programs needed to operate the following functions:

1.) User Interface

2.) Acquisition:

i.) Technique sheet creation for operator record ii.) Performance monitor and alert system iii.) Continuous acquisition mode

3.) Archival i.) The system shall support, at a minimum, the DICONDE network service classes Image storage to send data to an archival system and Query/Retrieve to search for and retrieve data from an archival system.

4.) Image Processing/Analysis:

i.) All image data and metadata generated by the system shall be exported in a format, fully compliant with ASTM E2339-20 to ensure non-proprietary multiple image format output/inputs.

ii.) Live imaging iii.) Live averaging iv.) Video capture v.) Automatic Statistical Process Control calculations and export to spreadsheet

5.) Combination of two or more datasets regardless of initial acquisition settings

6.) Measurement functions on voxel, point cloud, mesh, and CAD data shall include the following:

i.) Geometry element fitting optimized for voxel, CAD, and mesh data ii.) Registration of boundary conditions iii.) Alignment and registration of scan data iv.) Generation and creation of datum systems

7.) Porosity/Inclusion Detection and Analysis i.) Calculation of various defect parameters (e.g. position, size, geometry)

8.) Wall Thickness Analysis

9.) 3-Dimensional Volume Rendering i.) Real-time rendering ii.) Export slices at any angle iii.) Video creation iv.) Localized reconstruction

10.) Image Reconstruction i.) Cone-Beam reconstruction ii.) Fan-Beam reconstruction

11.) CAD Import and Compare i.) Import CAD files with PMI (PTC-CREO) ii.) Import STEP files (ISO 10303) iii.) Nominal/Actual Comparison shall perform alignment of acquired data to nominal model based on datum systems. The system shall compare acquired data to a nominal model with applied Geometric and Dimensional Tolerancing IAW ASME Y14.5-2018. Perform reporting of surface deviation from virtual condition with pass/ fail indication based on permissible tolerance range.

12.) Export:

i.) The following types of files: STL (Stereolithography), cloud points, OBJ, DXF, WRL, PLY.

ii.) Executable viewer module with a dataset to allow others to view, slice, rotate, window and manipulate the dataset on a traditional laptop or desktop computer.

13.) Automatic Detector Roll, Pitch, Yaw Measurement and Calibration: The system shall have a method for automatically calculating and compensating for detector roll, pitch, and yaw. This technology will provide precise measurements needed for metrology and reverse engineering capabilities.

14.) System Geometry Verification: The system shall have ring reduction based on detector movement. Ring reduction technology shall add no more than 20% of time increase to the scan.

15.) Dead Pixel Compensation: The system shall have a mechanism for compensation of dead pixels to preserve full detector capabilities even after some individual pixels stop working.

16.) Motion Control Programming

17.) Embedded Operating System

18.) Any operating system shall incorporate an IA Enabled Operating System that has been validated or is being evaluated by NIAP or CC scheme and shall:

i.) Be configurable in accordance with applicable DoD Security Technical Implementation Guides (STIGs). DoD Security Technical Guides are available at https://public.cyber.mil/stigs/.

ii.) Incorporate the DoD Information Assurance Vulnerability Management Program (IAVMP) in accordance with DoDI 8500.2.

iii.) Be supportable for the expected lifecycle of the system.

3.14 Safety

a.) The contractor shall deliver a system that is designed and documented to enable the Governments compliance with all applicable Occupational Safety and Health Administration (OSHA) standards and with DODI 6055.08.

b.) In addition to DODI 6055.08 the system shall enable the Government to maintain their local ionizing radiation protection program as described in FRCSWINST 5104.2L w-CH-1. The system’s hardware, software, and supporting documentation must meet the following requirements. The system shall be designed to ensure that when properly operated, no employee is exposed to radiation levels that would require personnel dosimetry under 29 CFR 1910.1096(d).

c.) Contractor shall provide a radiation survey procedure as described in section 5 of this SOW.

d.) All Electrical systems, components, wiring, and installation practices shall be designed, constructed, and installed to ensure safety from fire and electrical shack hazards. The system shall fundamentally comply with the principles and practices outlines in NFPA 70, National Electrical Code (NEC). To confirm that the system is following NFPA 70 the system shall be certified by a Nationally Recognized Testing laboratory (NRTL) (e.g., UL, ETL, CSA).

e.) The system shall be equipped with a single, clearly labeled, lockable primary energy isolation device that de-energizes all hazardous energy sources, including electrical and mechanical motion systems IAW 29 CFR 1910.147. This procedure shall be included in the technical manual and will serve as the basis for the Governments own internal LOTO safety program. The procedure must identify all energy sources and detail the steps to isolate, lock, and verify a zero-energy state before any service or maintenance is performed.

f.) The CT X-ray Cabinet system, as delivered and installed, shall be certified, listed, or labeled by a Nationally Recognized Testing Laboratory (NRTL). All internal moving components, including the CT gantry, part manipulator, and shall be guarded to prevent employee injury from pinch, crush, or entanglement hazards when access to the cabinet interior is required for maintenance or setup (under LOTO conditions) IAW 29 CFR Subpart S and 29 CFR 1910.212.

g.) The contractor shall provide a complete inventory of all hazardous materials used in the construction of the system. For each identified hazardous material (e.g., shielding, dielectric fluids), the contractor shall provide a current Safety Data Sheet (SDS) that is compliant with the requirements of 29 CFR 1910.1200. This documentation is required for Government acceptance of the system.

h.) The CT X-Ray cabinet shall conform to radiation safety and labeling requirements as outlined in 21 CFR 1020.40.

i.) Each door of the cabinet CT X-Ray NDI system shall have a minimum of two safety interlocks. One, but not both, of the required interlocks shall be such that the door opening results in physical disconnection of the energy supply circuit to the high-voltage generator and such disconnection shall not be dependent upon any moving part other than the door. The primary door interlock shall be of conventional design. The second door interlock must physically disconnect the energy supply circuit to the high voltage generator. Physical disconnection means opening the energy supply circuit by removing a piece of the circuit. This is usually accomplished with a “knife-edge and finger stock” or “plug and socket” type connection. Each access panel shall have at least one safety interlock. Access panel interlocks are not required to physically disconnect the energy supply circuit. Following interruption of x-ray generation by the functioning of any safety Interlock, use of a control provided, shall be necessary for resuming x-ray generation. Failure of any single component of the cabinet X-Ray system shall not cause failure of more than one required safety interlock the key switch shall be made to prevent the initiation of X-Ray production when in the “OFF” position. It must comply with all applicable regulations described in 21 CFR 1020.40.

j.) The CT X-Ray NDI system shall have emergency stop latching switches IAW 21 CFR 1020.40 and at a minimum emergency stop switches shall be available in the following locations:

1.) Mounted to the CT X-Ray NDI system

2.) Wall mountable with wire tether no less than 30ft in length.

k.) The workstation shall have a control or controls to initiate and terminate the generation of X-Rays other than by functioning of a safety interlock or the main power control.

l.) The CT X-Ray NDI system should provide an output signal indicating the systems current status. Instructions for interpreting this signal shall be provided. The following status indications shall be available at a minimum:

i.) Machine Idle ii.) Machine Running (Radiation on light with proper labeling and X-Ray system in operation) iii.) Machine Fault (Operator Intervention Required) iv.) Emergency Stop

3.15. Supporting material

a.) Software support, all proprietary software required for the complete functioning of the machine shall be provided. The system shall be provided with at least 1 software license for the government to install and delete multiple times on at least the number of machines covered by the contract. The contractor shall disclose a price at the time of the proposal for additional copies/licenses for the software in the event it would be to the advantage of the government to utilize the software on computers other than the ones that are dedicated to running the machine. Support shall include updates and troubleshooting support. Updates shall be provided at any time that they are made available. The government shall be supplied with any updates by the time they are offered on the open market at the latest. If no software updates are issued within a calendar year, the contractor shall issue a letter on its company letter addressed to the TPOC to serve as proof that the software is up to date. Support scan includes online support and/or telephone support during normal working hours. Support shall be sufficient for government IT professionals to troubleshoot and resolve any issues that may arise due to software performance or conflicts. Other services that are not covered in this section shall be made available as an option to the government. Prices for these additional services shall be disclosed at the time of proposal.

b.) The following documents shall be supplied with the CT X-Ray NDI system: Operation Manual, Radiation Safety Manual, Maintenance Manual, and Installation Manual. Each document listed is described in section 5 of this SOW.

c.) All manuals and documentation pertaining to the operation, assembly, installation, and engineering designs of the system shall be delivered at least 60 days after contract award to Naval Air Station North Island. These manuals must include any facility requirements for the system. Details of these documents are described in section 5.1.b.

3.16. Installation

a.) The contractor shall provide all qualified personnel and equipment to ensure complete installation of all new equipment. The contractor shall provide all materials and tools necessary for complete installation of the CT X-Ray. The contractor shall take into consideration the artisans’ safety with respect to 29 CFR 1910.1096, 29 CFR 1910.14, 29 CFR Subpart S and 29 CFR 1910.212. Installation shall be accomplished in the space shown in Layout Drawing and follow FRCSW Work Restrictions regarding access for contractors and all involved.

b.) Complete installation shall include:

1.) Transportation

2.) Preparation

3.) Assembly

4.) Testing

3.17 Reserved Space

3.18 Training

a.) Training shall be performed at FRCSW utilizing the equipment and O&M manuals provided. Onsite training by the supplier of the equipment shall be for up to a total of six (6) Engineers and Engineering Technicians. It is understood that some training notably for image analysis may be beneficial to the Government and convenient for the supplier to be performed by the company that developed the software supplied with the unit. Such arrangements shall be disclosed at the proposal stage of the project with a clear statement that at least two (2) seats shall be provided for that training at no additional cost to the government. Onsite training by the supplier shall include two parts as described in paragraphs “b” and “c” below.

b.) Onsite Training

1.) Definitions

2.) Theory of Operation

3.) Typical qualitative values under normal conditions

4.) Image analysis training c.) Hands-on Training

1.) Startup after an extended period of non-use

2.) Startup of system for normal/daily operation

3.) Process Control monitoring and checks

4.) Set up of part to be inspected

5.) Inspection of part including all functions

6.) Shut down procedure for normal/daily operation

7.) Shut down procedure for an extended period

4 VERIFICATION & ACCEPTANCE

4.1 Requirement Applicability

a.) Required Verifications

1.) The basic objective of verification is to ensure compliance with the applicable requirements of Sections 2 and 3.

2.) All the certifications mentioned shall be delivered with the system and have official marks present for acceptance. All deliverables mentioned above shall be available when the system installation is complete and destination testing has started.

3.) Responsibility for Inspection: Contractor shall perform inspection requirements specified herein. The Government reserves the right to perform any inspections set forth in the SOW where such inspections are deemed necessary to ensure supplies and services conform to prescribed requirements.

4.2 Acceptance Test Plan

a.) Contractor shall prepare an Acceptance Test Plan (ATP) as described in section 5 of this SOW.

4.3 Verification Methods

a.) Verification of the Computed Tomography X-Ray Cabinet System requirements will be accomplished by 1) documentation and 2) demonstration samples and 3) destination testing.

1.) Documentation refers to official signed documents which provide verification of a vendor’s claims.

2.) Demonstration samples are defined as samples provided by the vendor or government that verify the claims that the requirement has been met during destination testing. If the vendor supplies the demonstration sample, they must provide documentation stating why the samples provided sufficiently proves that the requirements have been met.

3.) Final Inspection Acceptance at Destination: The final acceptance test shall be performed only after the system is assembled and installed at its final location. The acceptance test will consist of the following:

i.) The final examination of the equipment shall be examined for design, dimensions, construction, materials, components, electrical equipment and workmanship to determine compliance with the requirements.

ii.) Motion control tests will consist of initiating movement and measure for accuracy for each axis provided. Motion limits shall meet or exceed the defined parameters from Section 3 of this SOW. Each axis will be moved to its limits and measured for accuracy both simultaneously and independently of all other axis to determine if there are any conflicts with the motion of the gantry.

iii.) The operational test will consist of the system successfully and accurately scanning the demonstration sample and perform all post scanning operations such as producing a 3d model, imagery, and analysis as described in Sections 2 and 3 of this SOW.

iv.) Unless otherwise specified within this document, instruments, materials, material handling equipment, qualified personnel, and tools required to perform and evaluate the tests shall be furnished by Contractor.

v.) The vendor shall provide a Post Installation Radiation Survey as described in Section 5 of this SOW.

5 DELIVERABLES: Contract Data Requirement List (CDRL)

5.1 Site Prep Requirements – (CRDL A001)

5.1.1 Facility Requirements Document (FRD): This document shall include all facility requirements that are needed to fully install and operate the system. The information should include at a minimum: fixture space, footprint requirements, floor loads, surface finish, anchors, tie downs, humidity, utility, room temp, and vibration requirements.

5.2 Manuals - (CDRL A002)

5.2.1 Installation Manual: This manual shall contain, at a minimum, the facility requirements regarding power, foundation, environmental controls, pneumatic requirements, and hydraulic requirements to maintain and operate the system at capacity. This manual will be used as a guide to assist with organizing the arrival of the machine for planned routes and closure of areas to assist with delivery. The manual shall contain all safety requirements and equipment necessary to assist with delivery and installation of the machine.

5.2.2 Operational and Radiation Safety Manual: This manual shall contain at a minimum instructions and procedures for proper operation of the equipment provided. This manual shall contain all necessary resources for a trained engineer, engineering technician, or production artisan to start up the machine from a cold start after being down for an extended period of time. This manual shall describe how to operate the machine at capacity meeting all performance parameters as set forth in this document. This document shall contain instructions to properly shut down and restart for short periods(e.g. – 15-60 minute periods.), continuing operations, and shutting down for extended periods of time (e.g. – up to and extended period beyond 7 days). Instructions and procedures set forth shall allow continued operations as necessary and keep the equipment operating at capacity and identify radiation safety procedures when operating this machine.

5.2.3 Maintenance Manual: This manual or portion of a single O&M manual shall contain, at a minimum, the theory of operation, detailed preventative/periodic maintenance procedure, list of required expendables, list of recommended spare parts, a section that covers corrective maintenance, electrical schematics, and original equipment manufacturer literature. All drawings and schematics shall be compliant with ASME: Y14.100 Engineering Drawing Practices. Theory of operations shall include the basis of design including the concepts from physics and chemistry that make the machine work properly. The contractor shall provide a single compiled section for Preventative Maintenance (PM). This portion of the manual shall include all recommended PM prescribed in parameters of both usage in units of displacement covered or hours of use and by absolute time as measures by a clock or calendar. PM tasks shall be listed in an orderly format that is intuitive with the necessary sequence to keep the equipment operating at capacity and meeting the performance prescribed in this document. A list of expendable items shall be included. The list of expendable items shall identify all spare parts including the manufacturer and specific identification numbers (model number/part number) of each item to procure the exact item required later from an authorized dealer. In addition, the contractor shall use this manual to identify any suitable substitutes should the original item be unavailable at the time it is required. It is understood that not all items will have a substitute, but every effort shall be made to locate alternative items that could be used to repair the machine. A section of Corrective maintenance shall include a listing of the most severe and the most likely modes of failure alone with the most likely causes of each failure. Likely causes shall also be linked to alternative solutions to failure. This portion of the guide shall be formatted so that it can be used by an operator of the system as a resource in the field when diagnosing issues on the machine.

5.3 Testing, Inspection, & Report (CDRL A003)

5.3.1 Acceptance Test Plan: The contractor shall prepare an Acceptance Test Plan (ATP). The ATP shall be a step-by-step written instruction on how to verify compliance during the final acceptance test specified in Section 4.3. The ATP shall incorporate the manufacture’s standard testing procedures and supplement them with specific test protocols using vendor provided test objects fully demonstrate compliance with Sections 2 and 3 of this SOW. At a minimum, these protocols must verify the following:

1.) Documentation: All required certifications, including NRTL electrical safety, and 21 CFR 1020.40 radiation compliance.

2.) System Capability: All advanced imaging functions, including dual-tube operations, 2D inspection, 3D volume reconstruction, sub-pixel resolution, single-pass scanning for elongated objects, and CAD-to-scan comparison.

3.) Key performance benchmarks such as achieving 6 µm voxel resolution and precise manipulator control within the specified travel limits.

4.) Safety Mechanisms: The functionality of all safety systems, including door interlocks, emergency stops, fail-safe warning lamps, and a certified post-installation radiation survey confirming leakage does not exceed 0.5 mR/hr.

The initial ATP shall be submitted within sixty (60) calendar days after post award conference to FRCSW’s TPOC and Contracting Agency for review. FRCSW reserves the right to comment on the draft plan.

A final acceptance test plan shall then be delivered to the FRCSW TPOC at least thirty (30) days prior to the Final Acceptance Test.

6 WARRANTY

6.1 Upon final acceptance, an industry standard commercial warranty shall be provided, that follows “start-up, system(s) testing, and acceptance/recognition of project completion,” by the Government/FRCSW and final payment acceptance by the Contractor.

7 SPECIAL REQUIREMENTS

7.1 Security and Base Access:

7.1.1 Security Forms: The Contractor shall coordinate with the TPOC to obtain, complete and submit SECNAV Form(s) 5512/1 and FRCSW Form 5512/5.

7.1.1.1 SECNAV Form 5512/1:

Contractor shall submit one SECNAV Form 5512/1 for each individual Contractor personnel requiring base access.

7.1.1.2 FRCSW Form 5512/5:

Contractor shall submit one FRCSW Form 5512/5 listing all contractor personnel.

7.1.2 Upon arrival, all Contractor personnel shall report to the Visitor Control Center (VCC) Bldg.680, which is located near the Main Gate to Naval Base Coronado (NBC), NAS North Island, San Diego, CA. Contractor personnel shall check in and request a Defense Biometric Identification System (DBIDS) card. Only personnel in compliance with Section 6.1.1 will receive a DBIDS. Contractor personnel that do not possess a DBIDS will be refused entry to NBC.

7.1.3 Following receipt of a DBIDS, Contractor personnel shall coordinate with the TPOC to obtain visitor badges through the FRCSW Quarterdeck, located in Building 94. Contractor personnel shall submit a federally issued identification card to obtain a Visitor badge.

7.1.4 Contractor personnel shall report to FRCSW Quarterdeck at Building 94 before start of daily work to obtain visitor badges. Visitor badges shall be worn and visible at all times while on FRCSW work site.

7.1.5 After completion of daily work Contractor personnel shall return visitor badges to FRCSW Quarterdeck at Building 94.