CArm MECs.docx

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C-Arm X-Ray with Annual Maintenance and Calibration
Solicitation number
0012269399
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This document is a Minimum Essential Characteristics (MEC) specification for a C-Arm X-Ray System required by the U.S. Army Aeromedical Research Laboratory (USAARL). The system must be mobile, compact (≤800 lbs), and feature a sophisticated imaging and operational capability, including a 30 cm image intensifier, CMOS detector, high-voltage generator, and multiple operating modes such as digital radiography, fluoroscopy, and digital cine mode. The system requires advanced digital imaging software with interactive user interface, dose management capabilities, and comprehensive post-processing functions.

Key additional requirements include DICOM format compatibility, 300,000 image storage capacity, data security compliance with DoD standards, USB/DVD data transfer capabilities, and a portable peripherals cart. The procurement includes on-site training (minimum 24 hours), a 12-month parts and labor warranty, and delivery to USAARL at Fort Novosel, AL. The system will be used for biomechanical research to establish human injury tolerances and develop protective equipment design metrics, specifically for analyzing medical images of human anatomical regions with and without personal protective equipment.

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Minimum Essential Characteristics- C-Arm X-ray System One C-Arm X-ray System with the following qualities is required:

1. C-arm must be mobile, compact, and lightweight (less than or equal to 800 lbs)

2. C-arm must have a braking system for wheels/casters

3. C-arm must be adjustable in a minimum of 6 degrees of freedom

4. C-arm must have at least a 30 cm image intensifier with a minimum 1952 x 1952 CMOS detector and:

· Contains a high-voltage generator, at least 2.3 kW

· Has a handle for easy placement over subject

5. C-arm must have a control unit with a minimum of the following functions:

· control position, operating mode, dose and frame settings, and image manipulation

6. The System must be capable of the following operating modes, but not limited to:

· Digital (single image) radiography

· Fluoroscopy

· Digital Cine Mode

· At least 30 fps for up to 15 sec

7. The System must have a digital online imaging software

· Must have an interactive graphic user interface

· Must have algorithms or workflows for specified applications and body regions

· Must allow manual subject registration and import of existing subject information

8. The System must be capable of direct dose level selection

9. The System must be capable of measuring and displaying the dose area product or air kerma value real-time

· The System must be capable of automatically storing this data with subject image data

10. The System must have a foot or hand switch for radiation release

11. The System must have acquisition capabilities to automatically control dose, contrast, and brightness

12. The System must have at least two high resolution x-ray tv monitors

· A minimum of 19” each

· Capable of 1280 x 1024 at a minimum

· A minimum of black/white display

· Monitors must be able to move in a minimum 170° to allow the user maximum adjustability in relation to subject

· Monitors must have anti-glare

13. The System must have post processing capabilities to include, but not limited to:

· Image rotation

· Absolute and relative rotation angle display

· Left/right, top/bottom image reversal

· Accessible database of common optimum contrast and brightness for specified applications

· In/out zoom

· Digital shutters

· Positive/negative image display

· Movie function

· Text function that allows for comments on images

· 2D measurement of angles and distances

14. The System must be capable of DICOM formats and support DICOM software

15. The System must have a storage capacity of 300,000 images

· Capable of automatic storage for digital radiography

· Available for continuous and pulsed fluoroscopy to include single and multiple images

16. The System must have a USB interface and a DVD-R / CD-ROM read / write drive at a minimum to transfer data

17. The System must have data security in compliance with DoD security standards

18. The System must have ability to define user/role-based functionality, set data access permissions, and keep an audit trail to log system and data access

19. The System must have a data back-up in place (Ethernet connectivity to server and/or back-up power, etc)

20. The System must have portable cart for peripherals (monitor, keyboard, mouse, controls, etc) with:

· locking breaks

· integrated cable routing

· cable deflectors on all castors

21. Additional accessories are required to include, but not limited to:

· Connection for an external live monitor via VGA plug

· Keyboard – English (US) with alphanumeric pad and function, control, and cursor keys

· Remote Control- must be capable to control position, operating mode, dose and frame settings, and image manipulation at a minimum

· Spacer for increasing the minimum source-skin distance to at least 30 cm

· Integrated laser aimer for precise radiation-free positioning

· A minimum of two sets of service and operation manuals

22. On-site Training is required:

· A minimum of 24 hours of on-site clinical education training

· Training covers agenda items on the ASRT approved checklist

· Complimentary training course is offered

23. Warranty is required:

· A minimum of 12 months for parts and labor

· Additional warranty options and renewals must be available

24. Price includes delivery to USAARL, Building 6901, Fort Novosel, AL.

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