MODIFICATION
65 -- AFICA Medical Refrigeration Devices - Actively Cooled Devices RFI Response Form - Passively Cooled Devices RFI Response Form
- Notice Date
- 7/24/2015
- Notice Type
- Modification/Amendment
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- AFICA - AFICA- CONUS
- ZIP Code
- 00000
- Solicitation Number
- AFICA-15-RFI-MedicalRefrigerationDevices
- Archive Date
- 9/8/2015
- 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
- Passively Cooled Devices RFI Response Form Actively Cooled Devices RFI Response Form 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 a medical refrigeration device suitable in the military expeditionary medical environment. 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 Combat Command Surgeon's Medical Modernization Division (ACC/SGR) and the Air Force Special Operations Command Surgeon's Medical Modernization Division (AFSOC/SGR) are interested in new and novel medical refrigeration devices in two categories (1) actively cooled mobile medical coolers and refrigerators (battery operated), and (2) passively cooled high duration portable coolers. These devices are intended to p rovide the capability to store and transport blood, blood products and drugs while maintaining a controlled temperature. This technology must safe and suitable to operate in the military expeditionary medical environment. Information is being sought on both types of devices under this single request for information. ACC/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. Manufacturers are encouraged to submit all devices meeting the requirements below, and responses are not limited to a single device. 4. REQUIREMENTS: Information is currently being sought on medical refrigeration devices meeting the requirements listed below. Responses should address the requirements identified in this RFI, and the attached Vendor RFI Response Survey should be completed based on the category of the device (either 4A or 4B below). 4A. ACTIVELY COOLED DEVICE REQUIREMENTS: Essential Characteristic Threshold Objective Comment Shall have a Joint Airworthiness Certification (JAC) consisting of a "Safe-to-Fly" letter from the USAF for fixed and rotary wing aircraft and a Fleet Airworthiness Release (AWR) and an Aeromedical Certification Letter (AWC) from the US Army Required T=O Or willingness/ability to obtain prior to fielding 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) Required T=O 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) Yes T=O Shall be portable and impact-resistant and operable in wet, dry and dusty environments Yes T=O Shall operate from both external source and battery power Yes T=O Shall operate from internal battery supply/auto charge/auto switching Yes T=O Unit will auto switch to battery backup if AC power is interrupted. Auto charge battery when plugged in. Shall auto charge the battery when operating on AC power Yes T=O Shall operate with various power configurations 110/220V 50/60Hz 110/220VAC, 50/60/400HZ, 12/24 VDC Shall have visual alarms Yes T=O Visual alarms for temperature, battery use, low battery, charging, % battery power, door open, etc. Government shall have access to OEM repair parts, proprietary software and tools and service literature for DoD trained Bio Medical Repair Technicians without requiring attendance at OEM factory training Yes T=O 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, 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 manuals and should not require vendor service Yes T=O The system shall have Unique Item Identification markings in compliance with DFARS 252.211-7003 No Yes The supplier shall provide training on the device for operator and maintenance training (includes applicable costs of available training courses and materials). Training materiel can be via CD, web-based or in a manual form. Yes T=O Total Weight (Empty) < 150 lb < 50 lb CUBE (LxWxH) Exterior 40" x 24" x 24" 30" x 22" x 22" CUBE (LxWxH) Interior 18" x 14" x 13" T=O Internal battery (Reserve power) 48 Hr 96 Hr Maintain internal temp (Refrigeration) 2° - 8°C (35.6 - 46.4° F) T=O Operational temperature extremes -20° - 49° C (-4° - 120° F) -29° - 60° C (-20° - 140° F) Alarms Power loss / power less than 10% No Yes LOW temp alarm w/ time No Yes HIGH temp alarm w/time No Yes Door open No Yes Audible Alarm No Yes Display Temperature (Internal) No Yes Ambient Temperature No Yes Battery Level indicator 0 - 100% T=O Charging Indicator LED and/or LCD display T=O BATTERY POWER/ALT. Power / AC Power Indicator LED and/or LCD display T=O Power (dual toggle) Manual Switching Auto Switching Power system should automatically adjust to applicable power or revert automatically to battery backup. Should operate and charge internal battery while plugged into any external power source (automatic switching preferred). Ability to lock (w/padlock) No Yes Reinforced hinge No Yes Refrigerator will be used to store medications Ingress protection rating IP 33 IP55 Impact testing 1 m drop 2 m drop Reference: MILSTD 810G(can include case) Static weight loading 350 LBS 500 LBS Device itself should be able to tolerate the weight of a normal person with full equipment (350Lb Plus) - weight placed on the device Access Latch Deliberate action required T=O Prevent inadvertent opening, breach of thermal barrier. Internal (individual product rack or buffer system) No Yes Hold individual products upright. Should also provide some padding between blood products and interior of device. Separated compartment for medication 4B. PASSIVELY COOLED DEVICE REQUIREMENTS: Essential Characteristic Threshold Objective Comment TOTAL WEIGHT Empty < 75 lb < 25 lb CUBE (LxWxH) 30" x 24" x 24" 22" x 22" x 22" External dimensions CUBE (LxWxH) - Internal storage 15" x 15" x 15" (56 Liters/2scf) 10" x 10" x 10" (16L/0.5scf) Requires Ridgid Wall YES T=O Must be ridgid wall to meet ruggedness requirements; non-crushable under load ( > 100 lbs; 400 lb or greater is ideal) Maintain internal temp (Refrigeration/Cooler) 4 ± 2° C (39 ± 3° F) T=O Duration 48 Hr 96 Hr Duty cycle of cooler once internal temperature is cooled for use. Operational temperature extremes (-) 40° C to (+) 60° C (-40 ͦF to 140 ͦ F) T=O Ability to lock (w/padlock) Design of cooler should accommodate a standard padlock or combination lock. Cooler will be used to store medications. Reinforced hinge Cooler will be used to store medications Ingress protection rating IP 33 IP55 MILSTD 810G water/dust resistance (can include case) Impact testing 1 m drop 2 m drop MILSTD 810G (can include case) Access Latch Deliberate action required T=O Prevent inadvertent opening, breach of thermal barrier. Access Axis (top opening) YES T=O Internal (individual product rack or buffer system) YES T=O For storage of blood products: Hold individual products upright. Should also provide some padding between blood products and interior of device. Internal divider YES T=O Adjustable divided compartment (separate meds from blood products) Attachment Points NO YES Should be able to tie town inside vehicle and still open container. Attatchment points for carabiner or tie downs - that do not interfere with opening of unit. Device has integrated attachment points (crash worthy rated) that allow it to be secured to an aircraft without restricting access to the compartment. (For all approved placement orientations.) 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 medical refrigeration device as characterized by the requirements addressed in this RFI. If unable to provide a medical refrigeration device capable of meeting all requirements, the respondent should offer trade-off considerations. Please ensure responses specifically address each requirement listed in section 4. Requirements. At a minimum, please complete and return the table provided. 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/b249e2596409d70ca1c8093b99119ced)
- 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
- SN03810079-W 20150726/150724235512-b249e2596409d70ca1c8093b99119ced (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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