Attachment 1 Salient Characteristics DRAFT.pdf

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Vasculab GSX FDA K131860 (Brand Name or Equal) Non-invasive physiologic testing system
Solicitation number
W81K0225QA037
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About this file

The document is an attachment listing salient characteristics for a medical device procurement by the Department of the Army Medical Command. The requirement is for a Vasculab GSX (FDA K131860) non-invasive physiologic testing system to replace an aging machine at Madigan Army Medical Center. The system must provide diagnostic measurements for various vascular exams including ABI, WBI, Raynaud's, TOS, and other peripheral vascular disease assessments.

Key specifications include a 12-channel multi-port inflator, medical-grade antimicrobial computer with Windows 10, wireless remote control, 8 MHz & 4 MHz Doppler, arterial PPG channels, multiple cuff sizes, and a 2-year equipment warranty. Additional requirements mandate IAC standards compliance, PACS/DICOM compatibility, 12-hour battery operation, a high-definition web camera, and an infrared thermometer. The procurement is being conducted as a sources sought notice, potentially set aside for small businesses, with the NAICS code 339112 and a small business size standard of 1,000 employees.

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Text version

The list of components:

Brand name or Equal: Vasculab GSX (FDA K131860) with Ergonomic Variable Height Cart 12-Channel Multi-Port lnflator, Air Hoses for ABIITBI, Thigh, Calf, Upper Extremity Exams Medical Grade Antimicrobial /Washable All-In-One Computer with PCAP touchscreen Windows 10 OS or higher, Intel® Wireless Chip, Ethernet, WiFi, Bluetooth, Headset Enabled Antimicrobial / Washable Keyboard with Touchpad 24 Function Wireless Remote Control with Programmable Keys 8 MHz & 4 MHz Bi-Directional Doppler, Integrated Speaker 2-Channel Right and Left Arterial PPG with Clips, Cuffs: 2-12L EZ-Clean, 6-12 EZ-Clean, 4-10 EZ-Clean, 2-1.9 x 9 digit, 2-2.5 x 12 digit Warranty: 2-years on Equipment including Control Unit, Computer, and Hoses, 6 Months Patient Applied Parts Include at least One Full Day On-Site Installation / Training The performance requirements the product must meet: Must provide diagnostic, non-invasive physiologic measurements for a variety of exams such as ABI, WBI, Raynauds, TOS, TBIs, DBIs, etc.

The product to be used for Non-invasive vascular exams to aid in diagnosis of peripheral vascular disease.

The supply is required as soon as possible as the current machine is 3 years past life expectancy and has been showing signs of decline in performance since beginning of 2023.

Must be a reputable supplier with a product that meets IAC standards, allows for proper ergonomics of the operator and allows for transfer of exam into PACs Must meet IAC standards for producing diagnostic exams.

Must communicate with PACS/DICOM and contain the following: DICOM Modality Worklist (MWL) Storage (Store) and Structure Reporting (SR) System must be portable and be able to run solely on battery for up to 12 hours.

System must include a camera equivalent to LOGI-C920 Logitech C920 High- Definition Web Camera, USB-A Connection that incorporates any pictures, as needed for clarifying wounds or amputations or TOS positions and incorporate this data into the report page.

System must also include an Infrared Thermometer that is equivalent to TEMPLXTA DT-RS232 (Model: LXTA)

File details come from the government source that posted it. Updated .