SOURCES SOUGHT
65 -- AFICA Portable Ultrasound System
- Notice Date
- 7/10/2015
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- AFICA - AFICA- CONUS
- ZIP Code
- 00000
- Solicitation Number
- AFICA-15-RFI-PortableUltrasoundSystem
- Archive Date
- 8/25/2015
- Point of Contact
- Ashley Fredlock, Phone: 301-619-8600
- E-Mail Address
-
AFMSA.SG5T.Market@us.af.mil
(AFMSA.SG5T.Market@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT. 1. SUBJECT: The Air Force Medical Evaluation Support Activity (AFMESA) is conducting market research for a portable ultrasound system with viewer (i.e., iPad, iPhone, etc.) for the identification and imaging capabilities outside the radiology department with a point-of-care system for immediate results. Responses are due to this request for information (RFI) by 2:00 P.M. (EST) on August 10, 2015. 2. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided as a response to the RFI will not be returned. AFMESA will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future request for proposal (RFP). 3. BACKGROUND: The Air Force Special Operations Command Surgeon's Medical Modernization Branch (AFSOC/SGR) is interested in new and novel ultrasound technology which can provide high resolution imaging and recording in a portable device or system for use at the point of injury in austere environments. The mission sets include peace time operations, humanitarian, noncombatant evacuation operations, and Joint/combined contingency operations where medics may be located far-forward of any military treatment facilities. Medics are interested in using an ultrasound to perform a focused assessment with sonography in trauma (FAST) exam, pneumothorax detection, and limited musculoskeletal (MSK) presentations. Additionally, if the technology is capable of detecting broken bones or fractures and may be useful as an off-label solution, then include this in the response too. The handheld viewer will permit the operator or user to view, manipulate, and identify the image. AMC/SGR prefers commercial off-the-shelf (COTS), government off-the-shelf (GOTS), and foreign off-the-shelf (FOTS), and research and development (R&D) options that fulfill the capabilities outlined below. Manufacturers are encouraged to submit a response to this RFI, even if a system does not meet all the requirements at this time. For requirements that are not met, trade-off considerations will also be considered. 4. REQUIREMENTS: Information is currently being sought on the system meeting the requirements listed below. Responses should address the requirements identified in this RFI, particularly those outlined in 4A and 4B below. 4A. MANDATORY REQUIREMENTS: The candidate system must satisfy the following top-level requirements: •· Device must be "approved for market" (PMA), "cleared to market" (FDA 510k approval); or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR807.97 (a) (3) for Class I and II devices). 4B. FURTHER SPECIFICATIONS/CHARACTERISTICS: •· System shall conform to all applicable IEC standards (i.e., IEC 60601-1, Medical Electrical Equipment, General Requirements for Basic Safety and Essential Performance; and others as applicable). •· Shall be portable and operable in wet, dry and dusty environments (i.e., IP-67, MIL-STD-810, etc.). •· Impact "drop" testing. •· Shall operate from both external electrical power source and battery power. •· Electrical power configurations: 110 - 240VAC, 50 and 60HZ (@110VAC), 12/24V DC. •· Battery Operation: 12/24VDC. •· Shall be capable of providing imaging of the abdomen, pelvis, fractures or breaks, chest, head, neck, eyes, and extremities. •· Government shall have access to OEM repair parts, proprietary software and tools and service literature for DOD trained biomedical equipment techs (BMETs) without requiring attendance at OEM factory training. •· Operational temperature range: -4 to +120 deg F (-20 to +46.4 deg C). •· Humidity (RH) Operations: < 95% •· No proprietary tools or equipment required for repair, unpacking, setup, tear-down, or packing of the instrument. •· Vendor shall provide operator and maintainer training. •· Quality control modules and test equipment shall be included to allow for testing, repair, and calibration by BMETs. •· Service and operator manuals shall be available both electronically and in print. Shall also include, but not limited to: all schematics (e.g., electronic, pneumatic, and as applicable), troubleshooting guide, and theory of operation. Service manual should include parts layout with part numbers for each replaceable component. Service manuals should be identical to vendor service technician's manual and should not require vendor service. •· The system shall have Unique Item Identification markings in compliance with DFARS 252.211-7003. •· Shall operate in 2-D real time, M-mode, and simultaneous 2-D real time and M-Modes. •· Shall perform zoom and freeze frame image capture. •· Shall provide color Doppler; power Doppler, and duplex color capability. •· System shall provide capability to export DICOM, MPEG 4, JPEG, and BMP formatted images. •· The supplier shall provide training on the device for operator and maintenance training, both for initial and future deployment, as well as the cost of available training courses and materials. Training materials and courses and materials. Training materials and courses used in commercial deployment of the monitor devices are preferred. Training material can be via CD, web-based or in manual form. •· System shall support musculoskeletal (MSK) ultrasound presentation. •· System shall support Focused Assessment with Sonography in Trauma (FAST) and pneumothorax detection. •· Weight: < 10 pounds (threshold); < 5 lbs (objective). •· Size: < 2 cubic feet •· Display - Low/Extreme Light Capable. •· System shall be impervious to damage secondary to contact from spills, gel or bodily fluids. This may include membrane-like cover over controls or internal/subpanel seal or other methods. •· System shall provide (internal) data storage capability. •· System start-up time: < 15 seconds (threshold); < 5 seconds (objective). •· System shall be capable of software updates. •· System shall include handheld viewer for imaging (i.e., iPad, tablet, etc.). •· System display screen size: > 5.0 inches •· Shall include the following transducers: curved or sector array (under 5.0MHz); linear array (7.0MHz or higher); endo-cavitary probe; trans-esophageal probe). AFMESA seeks information about academic, prototype, developmental, foreign and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above. 5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Ashley Fredlock, Market Research Analyst, via e-mail to AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify Ms. Fredlock at the above listed email address. Each RFI response will receive a confirmation email; if a confirmation is not received please call 301-619-8600. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail. Responses must be received by this office on or before 2:00 P.M. (EST) on August 10, 2015. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information. The response should describe the company's capability to offer, field, and sustain the system as characterized by the requirements addressed in this RFI. If unable to provide a system capable of meeting all requirements, the respondent should offer trade-off considerations. Please ensure responses specifically address each requirement listed in section 4. Requirements. Additional detailed information is encouraged. 6. LATE SUBMISSIONS: Failure to respond to this RFI does not preclude participation in any future competition, nor will information provided in response to this RFI be used to exclude anyone from responding to any future requests for proposals. Communications with AFMESA in regard to this RFI will only be permitted in writing during the RFI response period. Responses to the RFI received by AFMESA after the submittal deadline and time indicated may be considered. The respondent assumes the risk of the method of dispatch chosen. Postmarking by the submittal date and time shall not substitute for actual response receipt. 7. OWNERSHIP OF RESPONSE TO RFI: All informational material submitted in response to this request becomes property of AFMESA. Physical samples will be returned to the vendor at the owner's expense. 8. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall AFMESA be responsible for any response preparation expenses, submission costs, or any other expenses, costs, or damages of whatever nature incurred as a result of the respondent's participation in this RFI process. Respondent understands and agrees that they submit a response at their own risk and expense, and release AFMESA from any claim for damages or other liability arising out of the RFI process. 9. ERRORS IN RESPONSE: AFMESA shall not be liable for any errors in respondent's response. Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all error or omissions contained in their responses. 10. ADDENDUM: AFMESA reserves the right to issue an addendum to this RFI at any time for any reason. 11. CONTACT INFORMATION: Ms. Ashley A. Fredlock Air Force Medical Evaluation Support Activity (AFMESA) 1270 Montevue Lane (Area B) Fort Detrick, MD 21702 Phone: 301-619-8600 AFMSA.SG5T.Market@us.af.mil
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/c3173da498f11dc3c09938293ec7de78)
- Place of Performance
- Address: Air Force Medical Evaluation Support Activity (AFMESA), 1270 Montevue Lane (Area B), Fort Detrick, MD 21702, United States
- Zip Code: 21702
- Zip Code: 21702
- Record
- SN03793371-W 20150712/150710235355-c3173da498f11dc3c09938293ec7de78 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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