1300802890_Eval_Xray_Equip1_Redacted.pdf

� JUSTIFICATION FOR SOLE SOURCE (Simplified Acquisitions S2,500 TO SISOK)

0 JUSTIFICATION FOR LIMITED SOURCE/BRAND NAME (GWAC TO SISOK)

KPT 4200-09

The service or material listed on (PR Number) PR 1300802890 is sole/limited source and competition/fair opportunity is precluded for reasons indicated below. There are no substitutes available for this matcriaVservice.

Restricted to the following source. Provide original manufacturer's name. (If a sole source manufacturer distributes via dealers, ALSO provide dealer information.)

Manufacturer: Yxlon.

Manufacturer POC & Phone #:

Mfr. Address: 5675 Hudson Industrial Park\vay / Hudson, OH 44236 Manufacturers Dealer/Rep:

Dealer/Rep Address/Phone Number

Description of the item or service required, the estimated cost, and required delivery date.

The X-ray system turns on and pulls a vacuum, but not able to generate X-rays. The services required are to trouble shoot the error codes and detennine why the tube will not turn on. Attempts over the phone have failed to find problem. The delivery date for trouble shooting would be as soon as Yxlon is able to come to Kevport hopefullv in the next six weeks. Until the evaluation is perfonned for an estimated cost of . the cabinet X-rav svstem is rendered not operational for non-destructive radiographic inspection of various components. As long as this X-ray system is not operational. Code 224 has lost all X-rav capabilitv since it is our only system. The inspection and option for repair shall not exceed All repairs to be evaluated at the time of service by government to ensure the repairs are done and are acceptable.

Specific characteristics of the material or service that limit the availability to a sole/limited source (unique features, function of the ite� etc.). Describe in detail why only ihis suggested source can furnish the requirements to the exclusion of other sources.

The evaluation for the cabinet X-rav svstem must be limited to the sole source of the Original Equipment Manufacturer (OEM) because of the unique features of the system's Yxlon X-rav tube that produces ionizing radiation. The cause of the damage and the extent of the damae.e is at this time unknown based on the limited tools and procedures that the authori1.ed users are permitted to conduct under the Radiation Affairs Support Office program related to a source of ionizing radiation. The expertise of the OEM is needed to assess the extent of the damaee and offer a path forward for possible svstem repair. If the repair to the tube head reqtiires the sleeve material be replaced it is a very delicate operation requiring precise alignment of the sleeve material within the tube head that onlv the OEM can achieve.

The cabinet X-rav svstem is under the oversight of the Naval Sea Svstems Command (NAVSEA) Detachment Radiation Affairs Support Office and its operations must be compliant with the requirements ofNAVSEA S0420-AA-RAD-010. Radiological Affairs Support Program Manual. and 21 CFR 1020.40. Radiological Affairs Support Program (RASP) Guidance for the Use of Cabinet X-Rav Svstems.

RASP Regulatory Guide 7 Rev. 0, states that authorized users are prohibited from performing any maintenance or repairs to a cabinet X rav svstem that may result in a modification to the system. even if recommended bv the manufacturer's instructions. Repair or maintenance of cabinet X-rav machines shall be conducted bv an authorized manufacturer representative except for routine maintenance that is designed to be performed by the user as stated in the manufacturer's technical manual.

TI1e X-ray svstem is five vears old. Purchasing a new machine equal to our current model at between $300.000 to $500.000, is not cost efficient nor called for in this case. These factors dictate the only feasible and economically responsible sourcing of this contract must be with repair through Yxlon.

_ Yes_The requested material or service represents the minimum requirements of the government

FILL IN ALL APPLICABLE BLANKS BELOW

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed. Describe the equipment you have now and how the new item/service must coordinate, connect, or interface with the existing system.

This evaluation seivice contract shall maintain the Yxlan X-ray tube specifications and perfonnance benchmarks per the manufacturer's levels and to applicable standards for all related peripherals. The cabinet X-ray system consists of the following items:

Tube: Yxlon 11077573 Generator: Yxlon 4033�0612 System Software: FXE Control Version 2.13.1.22954 Cabinet: National X-Ray NX522-225M, 5/N 021513

NUWC Keyport 4200/09 (Rev 5-2013)