Acoustic Stethoscope

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 on stethoscopes suitable for use in assessing patients in the aeromedical evacuation (AE) environment. Responses are due to this request for information (RFI) by 4:00 PM EDT four weeks from the date of posting. 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 Assistant Surgeon General for Modernization, Office of the Air Force Surgeon General (AF/SGR) has identified a need for a stethoscope with noise cancelling properties for use in AE missions undertaken by Critical Care Air Transport Teams (CCATT). CCATTs have identified a need for a stethoscope that will allow caregivers to more accurately assess patients in the AE environment. The background noise of aircraft in the AE environment averages 85 decibels (dB); this precludes the effective use of a standard stethoscope. Accurately hearing the presence or absence of heart, lung, and bowel sounds, and other physical findings may assist in detecting clinically significant changes in the patient's condition and/or may assist in averting adverse clinical events. Noise interference occurs via multiple venues including the ear pieces, the tubing, and the sensor/interface, where the sensor is most likely the entry point. AF/SGR prefers commercial off-the-shelf (COTS), foreign off-the-shelf (FOTS) or Government off-the-shelf (GOTS) and research and development (R&D options that fulfill the capabilities outlined below. 4. REQUIREMENTS: The stethoscope sought must operate in a high noise AE environment with the ability to detect the presence or absence of heart, lung, and bowel sounds, and other physiological sounds of a patient. Responses should address the requirements identified in this RFI, particularly those outlined in 4A and 4B below. 4A. MANDATORY REQUIREMENTS: The candidate stethoscope must satisfy the following top-level requirements: 1. Must be capable of passing air worthiness certification/safe-to-fly testing; this testing will be completed after the selection process 2. Must provide capability to determine the presence or absence of heart and lung sounds in the AE environment 3. Must provide proof of compliance with FDA regulations, Title 21 of the Code of Federal Regulations 4B. FURTHER SPECIFICATIONS/CHARACTERISTICS: 1. Must be able to detect the presence or absence of various types of sounds/tones in the AE environment including heart, lung, bowel, and Korotkoff sounds 2. Device can be battery operated and should include the following: a. Continuous use without replacing or recharging battery for extended periods of time b. Should maintain a full charge in the OFF position c. Must have an auto-off power save feature d. Should run on off-the-shelf batteries e. Should have a charge level indicator 3. Device must pass pre-flight test 4. Device should weigh no more than 3 pounds including batteries 5. Bell size should be standard size 6. Headset configuration should be a minimum and usable with airborne wireless intercom system (AWIS) 7. Device should be portable with carrying case 8. Device should have minimum parts excluding container/carrier 9. Must be easily adapted for use in multiple types of patients such as a pediatric or adult patient 10. Device must be water/liquid resistant 11. Must be reusable 12. Must be sustainable by the biomedical equipment repair technician (BMET) using common tools; no proprietary tools 13. Must have operator's and service manuals 14. Parts should be obtainable by any Department of Defense (DoD) entity without additional constraints 15. Shall meet standard infection control guidance 16. Device must not interpret Pulseless Electrical Activity as a heartbeat 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. CONTACT INFORMATION: Response to this RFI must be submitted to Virginia Wolcott, Medical Market Research Manager, via e-mail Virginia.Wolcott.CTR@detrick.af.mil. Responses must be received by this office on or before 4:00 PM EDT four weeks from the date of posting. 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. 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. The response should describe the company's capability to offer, field, and sustain a stethoscope as characterized by the requirements addressed in this RFI. If unable to provide a stethoscope capable of meeting all requirements, the respondent should offer tradeoff considerations. 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 with 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 become property of AFMESA. Physical samples will be returned to 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 it submits its response at its own risk and expense, and releases 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.