PRESOL | 65 | Small, portable medical oxygen generation systems. The preferred system will include a battery power source, external power capability and the capability to restart the system and control oxygen flow rates.

FBO DAILY ISSUE OF MARCH 22, 2009 FBO #2673
SOLICITATION NOTICE

65 -- Small, portable medical oxygen generation systems. The preferred system will include a battery power source, external power capability and the capability to restart the system and control oxygen flow rates.

Notice Date: 3/20/2009
Notice Type: Presolicitation
NAICS: 339999 — All Other Miscellaneous Manufacturing
Contracting Office: Department of the Air Force, Air Force Materiel Command, 77AESG -Aeronautical Systems Group, 7980 Lindbergh Landing, Brooks City-Base, Texas, 78235-5119, United States
ZIP Code: 78235-5119
Solicitation Number: DOGS-S-1
Archive Date: 5/2/2009
Point of Contact: Terry Wilkinson,, Phone: 2105364109
E-Mail Address: terry.wilkinson@brooks.af.mil
Small Business Set-Aside: N/A
Description: Request For Information for Deployable Oxygen Generation System -Small (DOGS-S) Background and Purpose: The Human Systems Group is seeking information from sources that can provide a small, portable oxygen generation system for the Ground Medical, Aeromedical Evacuation (AE) and Special Operations missions. The preferred system characteristics include a battery power source, external power capability, and the capabilities to restart the system and control oxygen flow rates This RFI is for information and planning purposes only and is not to be construed as a commitment by the government. This is NOT a Request for Proposal, Invitation for Bid, or an announcement of a solicitation. Response to this RFI is strictly voluntary and will not affect any corporation's ability to submit an offer if a solicitation is released. There is no bid package or solicitation document associated with this announcement. The purpose of this document is to identify potential sources. Any requests for a solicitation package will be disregarded. The Government does not intend to award a contract on the basis of this RFI or otherwise pay for the information solicited. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of preparing submissions in response to this RFI and the Government's use of such information. Submittals will not be returned to the sender. Respondents of this RFI may be requested to provide additional information/details based on their initial submittals. For submissions to be considered developers/sponsors must electronically supply (.doc or.pdf format) the preceding information in the order and format in which it is presented to terry.wilkinson@brooks.af.mil no later than 1700 hrs, 17 April 2009. Telephonic responses will not be accepted. Electronic Media can be mailed to 77 AESG/PSK, 7980 Lindbergh Landing, Brooks City-Base TX 78235-5119, ATTN: Mr. Terry Wilkinson. The Government recognizes that proprietary data may be part of this effort. If so, clearly mark such restricted or proprietary data and present it as an addendum to the non-restricted/non-proprietary information. The Government shall not be liable for or suffer any consequential damages for any improperly identified proprietary information. Proprietary information will be safeguarded in accordance with the applicable Government regulations. The Government reserves the right to select one, some, or none of the submissions for further investigation. Submissions shall not exceed twenty (20) 8.5 X 11 inch, single-sided pages per product. Product MSDS, independent technical reports, and laboratory reports may be attached in an appendix and will not count against the length requirement. Vendors who submit packages for review do so with the understanding that U.S. Government personnel as well as their support contractors will review their material and data. Respondents will not be contacted regarding their submission or information gathered as a result of this notice nor the outcome of the Government's review of the solicited information. Submitted information packages will be retained by the Government and not returned to the contractor. Contracting Office Address: Department of the Air Force, Air Force Materiel Command, 77th AESG/PSK, 7980 Lindbergh Landing, Brooks City-Base, TX, 78235-5119 Point of Contact(s): Mr. Terry Wilkinson, Contracting Specialist, Phone 210 536-4109, Fax 210 536-4109, Email terry.wilkinson@brooks.af.mil. RESPONSE GUIDANCE Request comment from interested parties to the following questions: DOGS-S Focus Questions 1. To your knowledge, have any advancement occurred in oxygen generation technology over the past 2 years that might benefit the DOGS-S program? 2. Please elaborate on your participation in any other efforts in relation to the DOGS-S program or similar commercial equivalents. 3. Can your system battery charge with a 110-220 vac power cable adaptor at 50, 60, and 400 Hertz? Provide technical data on your charger and battery. Please refer to draft P-Spec attached hereto. 4. For battery power operation what would be the longest duration providing the specified flow rates? 5. What is the storage shelf-life of your battery? 6. What types of monitoring and alarms does your system have? 7. Does your system work on a closed feedback with a pulse oximeter or re-breather? 8. Have any medical studies been conducted on your system? If so, please provide a copy. 9. Has Electromagnetic Interference (EMI) testing been conducted on your system? If so, please specify the tests conducted and the results. 10. The DOGS-S flow requirement is 10 LPM with 15 LPM as an objective. Does your system achieve this flow requirement within the specified weight, volume, and power? If not, what do you propose for weight, volume, and power to achieve these flows while meeting all other specified requirements? 11. What night vision compatible specification does your oxygen concentrator meet? 12. Does your oxygen concentrator meet MIL-STD-3009 for Night Vision Compatibility? If yes, please identify the sections of MIL-STD-3009 met. 13. What is your Rough Order of Magnitude (ROM) to build 7 prototypes to include testing and FDA approval (in terms of time)? How long would it take to fully develop DOGS-S based on these requirements? 14. The cost for this developmental effort is estimated to be between $750,000 to $1,200,000. Is this a reasonable estimate? If no, what is a reasonable range? 15. For planning purposes, what would be your estimated price per unit for 100 production units meeting the aforementioned requirements? 16. What would your estimated lead time (in days or months) be for these production units? What degree of confidence would you have on your production estimate? 17. Reference Section 4, Environmental Test Requirements of the DOGS-S PS. What would you consider to be the biggest challenge and present the highest risk for meeting the specified requirements. 18. What major components currently exist for your proposed system? What components would require a new design effort for your proposed system? 19. How much experience do you have with the FDA certification process? Would you require third party assistance for FDA certification of DOGS-S? 20. Can you meet the MTBF requirement in the DOGS-S PS? 21. What is your business size? If you are a Small Business, do you also qualify under any of the sub-categories (8(a), Small Disadvantaged Business, Woman Owned Small Business, Veteran Owned Small Business, HubZone Small Business, Service Disabled Veteran Owned Small Business, and HBCU/MI)? 22. If you are a Small Business, would you consider submitting a proposal as a prime contractor? 23. In what socio-economic programs do you now participate (e.g. Mentor Protégé, Indian Incentive, etc.)? What is the extent of your participation in these programs? ********************************************* STATEMENT OF OBJECTIVES FOR THE DEPLOYABLE OXYGEN GENERATION SYSTEM-Small (ENGINEERING AND MANUFACTURING DEVELOPMENT) STATEMENT OF OBJECTIVES (SOO) FOR DEPLOYABLE OXYGEN GENERATION SYSTEM-SMALL (DOGS-S) 1. INTRODUCTION This SOO describes the top-level objectives and requirements for the System Development and Demonstration phase of the DOGS-S. This SOO is intended to provide potential offerors a basis from which to develop and propose a contractor generated Statement of Work (CSOW), an Integrated Master Schedule (IMS) and, for proposal purposes, a Work Breakdown Structure (WBS). 2. SCOPE The Air Force requires a Food and Drug Administration (FDA) approved oxygen concentration system that generates gaseous oxygen at a purity of 93 percent USP from ambient air. The system will be used to administer therapeutic oxygen directly to patients. This system will be forward deployed to mature and immature Joint Operating Areas around the world to support a wide range of military operations under austere conditions for extended periods of time. The system will undergo an Integrated Defense Acquisition framework through design, development, build, and test that will demonstrate government requirements are satisfied. 3. OBJECTIVES A. Program Management □ Provide manpower, management expertise, facilities and materials to design, develop, build, test and demonstrate seven fully functional Engineering Demonstration Models (EDMs) to be delivered to the Government □ Develop, maintain and use a CSOW and IMS which are fully integrated to support delivery of the EDM units, all Government identified Contract Data Requirement List (CDRLs) items, and any contractor identified CDRLs □ Attend biweekly teleconferences, conduct and co-chair quarterly program management reviews (PMRs) and report meeting minutes for all events. Location and timing of quarterly PMRs shall be event driven and be mutually agreed upon. □ Develop, track, manage and report program cost, schedule, performance and risk through the Risk Management Plan (RMP), Monthly Status Report (MSR), Contract Funds Status Report (CFSR) and Cost/Schedule Status Report (CSSR). □ Obtain FDA certification prior to delivery of the first EDM. B. Financial Management □ Implement, maintain, and use a cost control reporting system that integrates the IMS, is traceable to the contractor's statement of work and provides program cost/schedule status reports through the CFSR and CSSR. C. Engineering □ Design, develop, build, test and deliver seven fully functional EDMs that meet all of the DOGS-S Performance Specification requirements. □ Design the system to minimize logistics support. □ Apply sound Systems Engineering principles that incorporate design reviews and audits (to include System Requirements Review (SRR) to be held during the post award conference, Preliminary Design Review (PDR), Critical Design Review (CDR), Functional Configuration Audit (FCA) and Physical Configuration Audit (PCA)), risk management, and periodic technical interchange meetings. These reviews and audits shall be event driven, consistent with the accepted (Government approved) entrance and exit criteria. The Government will chair the SRR, PDR, CDR, FCA and PCA. The contractor shall prepare agendas and minutes for these reviews and audits. □ Develop a systems engineering approach/plan that details entrance and exit criteria for each engineering review and audit. This plan shall be presented and delivered at SRR. □ Agenda and presentation slides for all formal reviews shall be submitted to the government 5 working days prior to each review. Once the slides have been submitted, any updates prior to the actual review shall be presented during the review. D. Logistics □ Provide Commercial Technical Manuals in two volumes for the EDM units. Volume I shall cover Operation of the system including but not limited to setup, operation, tear down, safety warnings and cautions, operators maintenance, storage and packaging instructions. Volume II shall cover Maintenance of the system including sufficient level of detail to include all schematics/drawings and illustrated parts breakdown (IPB) necessary to accomplish organizational/depot level maintenance by AFSC 4A2X1, Biomedical Equipment Repair Technician (BMET), at skill level 5. □ Identify Life Cycle Cost (LCC) drivers based on defined service life, consumable replacement, and spares replacement. □ A separate technical event for review of the commercial technical manual will be held to include M-Demo (Maintenance Demonstration) for government verification of the manual. E. Test and Evaluation □ Develop test plans and test procedures applicable for conducting qualification testing, first article acceptance testing to verify all of the DOGS-S Performance Specification requirements. □ Conduct qualification testing in accordance with the Government-approved test procedures to verify the EDM units meet the DOGS-S Performance Specification. □ Report on test results by delivery of a Failure Item Analysis Report and Final Test Report. □ Provide technical service to include training to support Government Operational Testing and Evaluation (OT&E). □ Support development of a Government generated Test and Evaluation Master Plan (TEMP) and participate as a member of the Test Plan Working Group (TPWG). □ Conduct Test Readiness Review (TRR) prior to qualification testing. The contractor shall co-chair the TRR and prepare the agenda and minutes of this meeting. TABLE OF CONTENTS 1.0 SCOPE 4 1.1 THRESHOLDS / OBJECTIVES 4 2.0 APPLICABLE DOCUMENTS 4 2.1 GENERAL 4 2.2 GOVERNMENT DOCUMENTS 4 2.2.1 Specifications, Standards, and Handbooks 4 2.2.2 Other Government Documents, Drawings, and Publications 5 2.3 NON-GOVERNMENT PUBLICATIONS 5 2.4 ORDER OF PRECEDENCE 5 3.0 SYSTEM REQUIREMENTS 5 3.1 SYSTEM DESCRIPTION 5 3.1.1 DOGS-S SYSTEM DESCRIPTION 6 3.2 CHARACTERISTICS 6 3.2.1 DOGS-S Key Performance Characteristics 6 3.2.2 Other Characteristics 7 3.2.4 Environmental Requirements 8 3.2.5 Reliability and Maintainability 9 3.2.6 Logistics 9 3.2.7 Human Systems Integration 9 3.2.8 Safety & Interchangeability 9 4.0 VERIFICATION 10 4.1 SCOPE 10 4.1.1 Responsibility for Verifications 10 4.1.2 Verification Method Definitions 10 4.2 VERIFICATION METHODS 11 4.2.1 DOGS-S Key Performance Characteristics 11 4.2.5 Reliability and Maintainability 16 4.2.6 Logistics 16 4.2.7 Human Systems Integration 16 4.2.8 Safety & Interchangeability 17 4.2.10 Packaging & Handling 17 5.0 PACKAGING, HANDLING, and TRANSPORTATION 17 6.0 NOTES 18 6.1 ABBREVIATIONS 18 6.2 DEFINITIONS (Not Used) 18 6.3 INTERFACE CHARACTERISTICS (Not Used) 18 6.4 OTHER REFERENCE DOCUMENTS 19 1.0 SCOPE The joint medical mission includes provisions for air, sea, and ground-based medical support for the full spectrum of medical care in deployed scenarios, including wartime operations, deterrence and contingency operations, peacetime engagement, crisis response, humanitarian relief, and Special Operations. Both ground-based and medical support and Special Operations require therapeutic oxygen. In response to these mission requirements, the AF has identified alternative material solutions utilizing the family of systems approach where gaseous therapeutic oxygen is generated at point of use using variety of technologies. One of the alternatives identified in the CDD is Deployable Oxygen Generation System Small (DOGS-S). This specification states the performance and verification requirements for the DOGS-S. 1.1 THRESHOLDS / OBJECTIVES In this specification a threshold requirement is defined in any sentence with the verb "shall." Where applicable, objective or desired requirements are included within the threshold requirement and are identified in braces {}. Key performance parameters (KPP) are identified with the @ symbol. 2.0 APPLICABLE DOCUMENTS 2.1 GENERAL The documents listed in this section are specified in sections 3 and 4 of this specification. This section does not include documents cited in other sections of this specification or recommended for additional information or as examples. While every effort has been made to ensure the completeness of this list, document users are cautioned that they must meet all specified requirements from documents cited in sections 3 and 4 of this specification, whether or not they are listed. 2.2 GOVERNMENT DOCUMENTS 2.2.1 Specifications, Standards, and Handbooks The following specifications, standards, and handbooks form a part of this document to the extent specified herein. MIL-STD-130N Identification Marking of US Military Property MIL-STD-461E Requirements for the Control of Electromagnetic Interference Characteristics of Subsystems and Equipment MIL-STD-810F Environmental Engineering Considerations and Laboratory Tests MIL-STD-1472F Human Engineering Design Criteria for Military Systems (Unless otherwise indicated, the most recent revision of the above documents available before contract award shall be used. Copies of these documents are available from the Standardization Document Order Desk, 700 Robbins Avenue, Building 4D, Philadelphia, PA 19111-5094.) 2.2.2 Other Government Documents, Drawings, and Publications The following other Government documents, drawings, and publications form a part of this document to the extent specified herein. Unless otherwise specified, the issues are those cited in this specification. 21CFR 800-1299 Federal Food and Drug Act - Medical Devices (As applicable) 21CFR 807 Subpart E Premarket Notification Procedures 2.3 NON-GOVERNMENT PUBLICATIONS The following documents form a part of this document to the extent specified herein. IEC 60601-1 Medical Electrical Equipment, General Requirements for Safety ISO 8359 Oxygen Concentrators for Medical Use, Safety Requirements ASTM F1464-93 Standard Specification for Oxygen Concentrators for Domiciliary Use ASTM F1463-93 Standard Specification for Alarm Signals in Medical Equipment Used in Anesthesia and Respiratory Care 2.4 ORDER OF PRECEDENCE In the event of a conflict between the text of this document and the applicable documents cited herein, the text of this document takes precedence. Nothing in this document, however, supersedes applicable laws and regulations unless a specific exemption has been obtained. 3.0 SYSTEM REQUIREMENTS 3.1 SYSTEM DESCRIPTION 3.1.1 DOGS-S SYSTEM DESCRIPTION DOGS-S shall generate therapeutic gaseous oxygen and continuously supply its product directly to patients. It shall operate on external power source using UL standard wall outlet and battery power source. DOGS-S shall be small enough to fit in a rucksack and light enough to be one man-portable. It shall be operationally used for ground-based medical assemblages, such as the Mobile Aeromedical Staging Facility (MASF). It shall be operational in the following aircraft: C-5, C-17, C-130, C-141, KC-10, KC-135, and CV-22 [T]. The following aircraft are objectives only: C-2A, HH-46D, CH-46E, CH-47, SH-60 series, UH-60 series UH-1N, KC-130 series, C-9N and associated Army aircraft {O}. 3.2 CHARACTERISTICS 3.2.1 DOGS-S Key Performance Characteristics [1] DOGS-S shall provide oxygen at a purity of 93% USP {99%} concentration. @ [2] DOGS-S shall be approved by the U.S. Food and Drug Administration as a medical device IAW 21CFR 807-Subpart E. @ [3] DOGS-S shall generate and deliver gaseous oxygen at a flow rate of 10 {15} LPM through an outlet. [4] DOGS-S shall have one outlet port for patient use, supplying the required flow rate at 5 psig minimum. [5] DOGS-S shall have the capability of regulating oxygen at flow rates ranging from 1.0 to its maximum flow generation rate at its outlet at 1.0 LPM increments. [6] DOGS-S shall be a single module excluding the power kit {including the power kit}. [7] DOGS-S shall operate at a maximum peak power consumption of 1.0 kW {0.1kW} at 110-220 VAC, 50/60/400 Hz, single phase. [8] DOGS-S shall also operate on rechargeable battery power running continuously for 2 {8} hours at maximum flow rate. [8.1]The battery shall be able to charge on 110-220 VAC, 50, 60, and 400 Hz, single phase. [9] DOGS-S shall fit within a rucksack occupying a total volume of 1.6 {0.026} cubic feet. [10] DOGS-S shall not exceed 15 {10} pounds total system weight NOT including rechargeable battery or power kit 3.2.2 Other Characteristics [11] DOGS-S shall have a system failure diagnostic Built-In-Test (BIT) capability, which provides the operator with fault indicator for pressure, oxygen purity, compressor, low battery, and filter change following ASTM F1464-93, section 10. [12] DOGS-S shall be equipped with a non-resettable elapsed time indicator showing the total system operating time in hours. [13] DOGS-S shall be capable of withstanding bacterial and/or viral disinfection with standard hospital disinfectants and five percent bleach solution without deterioration of material, surface finish and performance. [14] DOGS-S shall have an operational life of 10 {15} years and storage life of 15 years. (Note: This excludes the battery.) [15] DOGS-S shall operate on any orientation without performance degradation. [16] DOGS-S shall be capable of being set-up and be fully operational within 45 minutes after being removed from long-term storage in a non-environmentally controlled storage facility. [17] DOGS-S shall have indicators for monitoring delivery and generation of oxygen (i.e., pressure gage, oxygen purity, flow meter, and regulators). [18] DOGS-S shall have an audible alarm distinctly different from the sounds generated by the system during normal operations and visual alarms for low oxygen purity and pressure following ASTM F1463-93. 3.2.3 Interfaces [19] DOGS-S shall interface with the 110 VAC standard UL electrical plug. [20] DOGS-S outlet port shall interface with resuscitator, hand operated NSN 6951-01-279-8276UM. [20.1] DOGS-S outlet port shall interface with Mask, oronasal NSN 6515-01-282-1194UM. [21] DOGS-S shall interface with litters using litter straps and other securing method. (Note: This interface shall support requirement [32] for surviving acceleration exposure.) [22] DOGS-S shall interface/attach to the frame/harness of the combat rucksack. 3.2.4 Environmental Requirements Note: The context of "operate" as used in Section 3.2.4 shall meet all the threshold requirements of this specification while in operation. 3.2.4.1 Natural Environment [23] DOGS-S shall operate in relative humidity levels of 98% Rh, at 90 F, {100 % at 140 F }. [24] DOGS-S shall operate after exposure to storage temperatures of -40 F to +140 F [T], and {-65 F to 160 F }. [25] DOGS-S shall operate in ambient temperatures of 0F to +120 F [T], and -65 F to 160 F [O]. [26] DOGS-S shall operate during exposure to settling dust at a deposition rate of 6 g/m²/day. [27] DOGS-S shall operate after storage in a settling dust environment at a deposition rate of 6 g/m²/day. [28] DOGS-S shall operate during and after exposure to moisture with a salt content of 5% ± 1% by weight for a minimum of 48 hours. [29] DOGS-S shall operate during and after exposure to altitude of 15,000 ft. 3.2.4.2 Induced Environment [30] DOGS-S shall operate during and after exposure to the vibration curves representing jet, helicopter {O}, and turboprop aircraft, as specified in Section 4. [31] DOGS-S shall operate during and after exposure to the vibration levels of mission/field transportation on - truck, two-wheeled trailer and wheeled vehicle as a restrained cargo. [32] DOGS-S shall remain operational after exposure to functional shock pulse of in each orthogonal direction; X, Y, and Z. [33] DOGS-S shall operate during and after exposure to rapid decompression from 8,000 ft to 45,000 ft at 1, 7, and 60-second intervals, and shall not create a hazard to personnel or equipment. [34] DOGS-S and its securing device shall remain structurally intact so as not to create a hazard after exposure to the following accelerations; 9 G's forward, 1.5 G's aft, 4 G's left and right, 8 G's down, and 4 G's up. [35] DOGS-S shall operate in the electromagnetic environments of the ground-based medical assemblages and AE aircraft environment without causing or sacrificing any performance degradation due to electromagnetic interference to or from other equipment. [36] DOGS-S shall operate in explosive vapor atmosphere. 3.2.5 Reliability and Maintainability [37] DOGS-S shall have a Mean Time Between Failure (MTBF) of 2880 hours. [38] DOGS-S Mean Time to Repair (MTTR) shall be no greater than one hour at point of repair. [39] Not currently used. 3.2.6 Logistics [40] DOGS-S in its storage configuration shall be capable of allowing periodic inspection, preventive maintenance and corrective maintenance. [41] Technicians shall be capable of meeting all organizational level maintenance requirements using stock-listed tools as shown in Appendix A. 3.2.7 Human Systems Integration [42] DOGS-S shall emit no more than 60dB (A) of noise when measured at a radius of 1 meter from DOGS-S. [43] DOGS-S shall be designed to comply with the applicable portions of MIL-STD-1472F, Sections 4, 5.1, 5.2, 5.4, 5.6, 5.8.2.2, 5.9, and 5.11.1. [44] DOGS-S shall be designed to allow one skill level 5, technician to operate after initial training. [45] DOGS-S shall be designed so that calibration and maintenance actions can be accomplished by a skill level 5, biomedical equipment repair technician (AFSC 4A2X1). [46] DOGS-S shall be operable by a personnel wearing any level of Mission-Oriented Protective Posture (MOPP) gear (to include markings and labeling legibility). [47] DOGS-S shall be operable by a personnel wearing cold weather clothing to include standard military issue gloves or mittens. [48] DOGS-S shall have carrying capability to accommodate one-man portability. 3.2.8 Safety & Interchangeability [49] DOGS-S shall be designed to comply with all safety standards applicable to medical equipment and oxygen system IAW all applicable sections of IEC 60601-1 and other applicable Commercial/Industry standards. [50] DOGS-S markings and labeling shall meet the requirements of MIL-STD-130N (including UID). [51] Disposal of any of the DOGS-S components shall not pose a threat to the environment. [52] DOGS-S shall pose no safety hazard in the event of a single fault condition. [53] DOGS-S shall be designed for functional and dimensional interchangeability between each DOGS-S unit. [54] DOGS-S shall be equipped with a high efficiency product gas particulate filter rated at 0.1 micron to protect the patient in the worst case scenario that the concentrator molecular sieve material would dust. 4.0 VERIFICATION 4.1 SCOPE This section specifies the verification requirements to qualify the DOGS-S in meeting all of the requirements in sections 3 and 5. 4.1.1 Responsibility for Verifications Unless otherwise specified in the contract or this specification, the contractor shall be responsible for the performance of the verification methods specified herein. The contractor may use facilities of his own choosing suitable for the performance of the verifications, unless disapproved by the Government, the Government reserves the right to perform any of the verifications in this specification, where such verifications are deemed necessary to ensure that the DOGS-S complies with prescribed requirements. The verification descriptions in this specification are intentionally brief. The contractor shall fully develop the system's test procedures in accordance with the contract, including parameters or procedures not specified. 4.1.2 Verification Method Definitions One or more of the following methods shall be used for verification: Inspection: Verification without the use of special laboratory appliances or procedures. May include visual examination, simple physical manipulation, and/or mechanical and electrical gauging and measurement. Analysis: Verification that utilizes established technical or mathematical models or simulations, algorithms, charts, graphs, or other scientific principles and procedures Demonstration: Verification that involves actual operation, adjustment, or reconfiguration of an item under specific scenarios. Items may be instrumented and quantitative limits of performance measured. Test: Verification that involves thorough exercising of an item under specified conditions with instrumentation and data analysis accomplished IAW a set of applicable test procedures. 4.2 VERIFICATION METHODS In the following list of verification methods, test descriptions are denoted by the symbols "<" and ">". The term, "contractor's discretion," allows the contractor to determine the most appropriate verification method(s), contingent on the approval of the Government. The term, "system shall operate during and/or after this test" means that the system will operate IAW Sec 3.2 of this specification without any performance degradation. 4.2.1 DOGS-S Key Performance Characteristics (1) Oxygen purity shall be verified by Test. @ (2) FDA approval shall be verified by obtaining approval in accordance with FDA regulatory requirements for this type of medical device. @ (3) Oxygen generation rate shall be verified by Test < DOGS-S shall be tested IAW ASTM F1464-93, section 8>. (4) Oxygen outlet pressure shall be verified by Test. (5) The capability of regulating oxygen at flow rates ranging from 1.0 LPM to the maximum flow rate at 1.0 LPM increment shall be verified by Test. (6) Single module shall be verified by Demonstration. (7) Power consumption shall be verified by Test. (8) Continuous operation for 2 hours on battery power shall be verified by Test. (8.1) The charging of the battery shall be verified by Demonstration. (9) Dimensions shall be verified by Inspection. (10) Total system weight shall be verified by Demonstration. 4.2.2 Other Characteristics (11) Built-In-Test (BIT) capability which provides the operator with fault indicators shall be verified by Test and Demonstration. (12) Elapsed time indicator operation shall be verified by Demonstration. (13) Cleaning and disinfection shall be verified by Demonstration. (14) Operational and storage life shall be verified by Analysis. (15) Operation on any orientation shall be verified by Test. (16) Unit capable of being set-up and fully operational within 45 minutes after being removed from long-term storage in a non-environmentally controlled storage facility shall be verified by Demonstration. (17) Indicators for monitoring delivery and generation of oxygen (i.e., pressure gage, oxygen purity, flow meter, and regulators) shall be verified by Demonstration. (18) Audible and visual alarms shall be verifiedby Test and Demonstration. 4.2.3 Interfaces (19) Interface with 110 VAC standard UL electrical plug shall be verified by Demonstration. (20) Compatibility with hand operated resuscitator shall be verified by Demonstration. (20.1) Compatibility with oronasal mask shall be verified by Demonstration. (21) Interface with AE litters shall be verified by Demonstration. (22) Interface with the frame/harness of medical rucksack shall be verified by Demonstration. 4.2.4 Environmental Requirements 4.2.4.1 NaturaI Environment (23) High humidity operation shall be verified by Test. (24) High and low temperature storage shall be verified by Test. (25) High and low ambient temperature operation shall be verified by Test. (26) Operation during settling dust shall be verified by Test. (27) Operation after storage in settling dust shall be verified by Test. (28) Salt moisture operation shall be verified by Test. (29) Operation at an altitude of 15,000 ft shall be verified by Test. < DOG-S, in its operational configuration, is to be tested IAW MIL-STD-810F, method 500.4, procedure 2. DOGS-S shall operate at altitude for 30 minutes. 4.2.4.2 Induced Environment (30) DOGS-S aircraft vibration exposure operation shall be verified by Test. For the Jet Vibration Curve: Fig 514.5C-6 for C-17 and General Exposure curves. Exposure will be for 30 minutes per orthogonal axis (X, Y, Z). For the Propeller [T] and Helicopter Vibration {O} Curves: Exposure will be for 1 hour per orthogonal axis (X, Y, Z). Figure 514.5C-6, MIL-STD-810F is for reference only. Jet aircraft vibration exposure initial frequency shall be 15 Hz at an acceleration spectral density of.01 g²/Hz. Acceleration spectral density shall be maintained at.01 g²/Hz from 15 Hz to 105.94 Hz. The acceleration spectral density shall increase from.01 g²/Hz to.02 g²/Hz from 105.94 Hz to 150 Hz on a slope of +6 dB/octave and remain at.02 g²/Hz to 500 Hz. The acceleration spectral density shall then decrease from.02 g²/Hz to.0013 g²/Hz from 500 Hz to 2000 Hz on a slope of -6 dB/octave. Figure 514.5C-9, MIL-STD-810F, Propeller aircraft vibration exposure, shall be replaced with the following schedule: PROPELLER AIRCRAFT VIBRATION SCHEDULE [T] BP Frequency (Hz) Acceleration spectral density (g2/Hz) 1 15 0.010 2 48.45 0.010 3 48.45 0.3 4 53.55 0.3 5 53.55 0.010 6 64.6 0.010 7 64.6 0.300 8 71.4 0.300 9 71.4 0.010 10 96.9 0.010 11 96.9 0.300 12 107.1 0.300 13 107.1 0.010 14 129.2 0.010 15 129.2 0.0754 16 142.8 0.0754 17 142.8 0.0336 18 160.65 0.0336 19 160.65 0.010 20 193.8 0.010 21 193.8 0.0336 22 214.2 0.075 23 214.2 0.075 24 258.4 0.010 25 258.4 0.0189 26 290.7 0.0189 27 290.7 0.034 28 321.3 0.034 29 321.3 0.01 30 387.6 0.01 31 387.6 0.019 32 428.4 0.019 33 428.4 0.01 34 2000 0.010 5.5 grms The spikes are those frequencies whose acceleration spectral densities are other than 0.010 g2/Hz. The system shall operate during and after this test.> Figure 514.5C-10, MIL-STD-810F, Helicopter vibration exposure, shall be replaced with the following schedule and sinusoid tone values: With an initial slope of 99.00 dB/oct and final slope of -99.00 dB/oct. HELICOPTER VIBRATION EXPOSURE SCHEDULE {O} BP Frequency (Hz) Acceleration spectral density (g2/Hz) 1 10.0 0.0007 2 100.0 0.007 3 300.0 0.007 4 500.0 0.0007 SINUSOID TONE VALUES TONE FREQUENCY AND AMPLITUDES FREQ (Hz) ACCELERATION (g) X-AXIS Y-AXIS Z-AXIS 4.85 0.042 0.042 0.042 10.8 0.648 0.648 0.648 17.2 1.032 1.032 1.032 33.4 1.5 1.5 1.5 51.6 0.9 0.9 0.9 The system shall operate during and after this test.> (31) Ground-vehicle vibration exposure shall be verified by Test. (32) Functional shock shall be verified by Test. (33) Rapid decompression survival shall be verified by Test. (34) Acceleration exposure shall be verified by Test. (35) Electromagnetic interference emissions and susceptibility shall be verified by Test in accordance with the requirements and limits of MIL-STD-461E, requirements RE 102, CE 102, RS 103, CS101, CS114, CS115 and CS 116 {O}. (36) Explosive atmosphere performance shall be verified by Test. < DOGS-S is to be tested IAW MIL-STD-810F, method 511.4 (with change notice 1) at 120°F and altitude of 10,000 feet. DOGS-S will be exposed to a fuel-air explosive atmosphere. DOGS-S will be turned on and off three times. The test will be repeated at ground level.> 4.2.5 Reliability and Maintainability (37) Mean Time Between Failure (MTBF) shall be verified by Analysis. (38) Mean Time to Repair shall be verified by Demonstration. (39) Operational Availability shall be verified by Analysis. 4.2.6 Logistics (40) Access for periodic inspection, preventive maintenance and corrective maintenance while in storage configuration shall be verified by Demonstration. (41) Maintenance using stock-listed tools shall be verified by Demonstration. 4.2.7 Human Systems Integration (42) Noise level shall be verified by Test.. (43) This compliance with applicable portions of MIL-STD-1472 shall be verified by Analysis. (44) Ease of operation shall be verified by Demonstration. (45) Maintainability shall be verified by Demonstration. (46) MOPP gear compatibility shall be verified by Demonstration. (47) Cold weather clothing, gloves & mittens compatibility shall be verified by Demonstration. (48) Carrying capability for one-man carry shall be verified by Demonstration. 4.2.8 Safety & Interchangeability (49) Compliance with safety standards shall be verified by Analysis. (50) Markings and labeling shall be verified by Inspection and Analysis. (51) Compatibility with the environment when disposed of shall be verified by Analysis. (52) The requirement that DOGS-S shall pose no safety hazard in the event of a single fault condition shall be verified by Analysis. (53) Interchangeability shall be verified by Analysis. (54) Effectiveness of high efficiency product gas particulate filter shall be verified by Analysis. 4.2.10 Packaging & Handling (55) Packaging to meet air, sea, and surface transportation shall be verified by Analysis. (56) Packaging strength withstanding the vibration levels of requirements [30] & [31 shall be verified by Test. (57) Shipping container design to fit DOGS-S and accessories shall be verified by Demonstration. 5.0 PACKAGING, HANDLING, and TRANSPORTATION [55] DOGS-S shall be packaged to meet air, sea, and surface transportation. [56] DOGS-S when packaged for transport (initial delivery and operational use) shall be capable of withstanding the vibration levels of requirements [34] & [35] and the shock pulse level of requirement [37] without damage to the packaging and any components of DOGS-S. [57] DOGS-S reusable shipping container shall be designed to fit DOGS-S and its accessories (i.e., rechargeable battery(s), battery charger, any special tools, consumables, operator maintenance manual, etc.). 6.0 NOTES 6.1 ABBREVIATIONS AE - Aeromedical Evacuation AF - Air Force AFI - Air Force Instruction BIT - Built-In-Test CFR - Code of Federal Regulations CP-EMEDS - Collectively Protected Expeditionary Medical Support DOGS-S - Deployable Oxygen Generation System Small DOS - Deployable Oxygen System EMEDS - Expeditionary Medical Support FDA - Food and Drug Administration 77 AESG - Human Systems Group Hz - Hertz IAW - In Accordance With IEC - International Engineering Consortium ISO - International Organization for Standardization in/hr - inch per hour KPP - Key Performance Parameters KW - Kilowatt lbs - pounds LPM - Liters Per Minute (oxygen flow rate referenced to ambient pressure and 70F) MASF - Mobile Aeromedical Staging Facility MIL-STD - Military Standard MOPP - Mission Oriented Protective Posture MSL - Mean Sea Level MTBF - Mean Time Between Failure MTTR - Mean Time To Repair m/sec - meters per second PMI - Patient Movement Item psi - pounds per square inch psig - pound per square inch gauge Rh - Relative Humidity TBD - To Be Determined USP - United States Pharmacopoeia VAC - Volts Alternating Current 6.2 DEFINITIONS (Not Used) 6.3 INTERFACE CHARACTERISTICS (Not Used) 6.4 OTHER REFERENCE DOCUMENTS AFI 41-203 Electrical Safety In Medical Treatment Facilities APPENDIX A Biomedical Equip Technician Tool Kit NSN 5180-00-117-3414 List Of Contents # Quantity NSN # Description 1 1 3439-00-009-2334 Desoldering wick 2 1 3934-00-132-1331 Desoldering tool 3 1 3439-00-317-2732 Heating unit, electric soldering iron 4 1 3439-00-611-7136 Soldering aid tool 5 1 3439-00-631-6821 Handle, electric soldering iron 6 1 3439-00-801-0952 Tip, electric soldering iron 7 1 3439-NSL-0000 Solder, tin alloy, 22ft 8 1 3439-01-215-6406 Tip, electric soldering iron 9 1 5110-00-186-7107 Chisel, cold, ½" 10 1 5110-00-204-2685 File set, swiss pattern, needle, 12 pc 11 1 5110-00-234-6532 File, 6" flat smooth 12 1 5110-00-240-5943 Knife, electricians 13 1 5110-00-241-9147 File, 6" half round bastard 14 1 5110-00-246-0975 Stripper, wire, hand 15 1 5110-00-255-0420 Scissors, electricians' 16 1 5110-00-263-0349 Handle, file, wood 17 1 5110-00-935-0890 Pliers, diagonal, 4", CG 18 1 5110-01-314-1814 Pliers, diagonal, 6", CG 19 1 5120-00-056-3938 Nutdriver blade, 7/32" 20 1 5120-00-056-3940 Nutdriver blade, 9/32" 21 1 5120-00-056-3942 Nutdriver blade, 11/32" 22 1 5120-00-056-3943 Nutdriver blade, 3/8" 23 1 5120-00-056-3945 Nutdriver blade, ½" 24 1 5120-00-061-8541 Hammer, ball peen, 8 oz 25 1 5120-00-081-2305 Wrench set, socket, ¼" dr., 13 pc 26 1 5120-00-087-6415 Spline key wrench set, spline, 7 pc 27 1 5120-00-089-0874 Pliers, retaining ring 28 1 5120-00-112-9599 Hex key wrench set, metric, 7 pc 29 1 5120-00-152-2298 Nutdriver blade, 3/16" 30 1 5120-00-152-2299 Nutdriver blade, 7/16" 31 1 5120-00-159-8881 Nutdriver blade, ¼" 32 1 5120-00-159-8882 Nutdriver blade, 5/16" 33 1 5120-00-221-1542 Awl, scratch 34 1 5120-00-224-7446 Punch, prick 35 1 5120-00-240-5328 Wrench, adjustable, 8" 36 1 5120-00-240-5330 Wrench, adjustable, 4" 37 1 5120-00-240-6082 Punch, drive pin, 1/16" 38 1 5120-00-241-5521 Handle, nutdriver 39 1 5120-00-242-5966 Punch, drive pin, 1/8" # Quantity NSN # Description 40 1 5120-00-255-4458 Burnisher, contact, hand 41 1 5120-00-277-4243 Wrench, plier, 7" 42 1 5120-00-278-0326 Screwstarter, hand 43 1 5120-00-278-0351 Pliers, groove joint, 7", CG 44 1 5120-00-278-2423 Crimping tool, terminal hand 45 1 5120-00-288-7781 Alignment tool (GCT 8276) 46 1 5120-00-288-8739 Screwdriver set, jewelers 47 1 5120-00-293-0149 Tweezers, Craftsman's 48 1 5120-00-448-3924 Hook, spring adjusting (push) 49 1 5120-00-448-3927 Hook, spring adjusting (pull) 50 1 5120-00-508-9755 Alignment tool (GCT 5004) 51 1 5120-00-529-1475 Hex key wrench set, 11 pc 52 1 5120-00-851-4247 Screwdriver bit set (99PS-40) 53 1 5120-00-962-7580 Wrench set, O.E. ignition 8 pc 54 1 5120-00-965-0604 Wrench, plier, 5" 55 1 5120-00-NSL-0000 Hex key wrench set, 13 pc 56 1 5120-00-NSL-0001 Pliers, long nose 4-1/2", CG 57 1 5120-01-064-1943 Screwdriver bit set and handle (M60) 58 1 5120-01-106-3753 Screwdriver bit set 59 1 5120-01-188-3879 Pliers, slip joint, 6", CG 60 1 5120-01-197-5408 Pliers, long nose, 6", CG 61 1 5120-01-261-6873 Pliers, groove joint, 10", CG 62 1 5120-01-313-4096 Mirror, inspection 63 1 5120-01-335-6882 Screwdriver, cross tip #1 X 3" HP 64 1 5120-01-335-6884 Screwdriver, cross tip #2 X 1-1/2" HP 65 1 5120-01-335-6885 Screwdriver, cross tip #2 X 4" HP 66 1 5120-01-335-8531 Screwdriver, flat tip ¼" X 4" HP 67 1 5120-01-335-8542 Screwdriver, flat tip 5/16" X 6" HP 68 1 5120-01-335-8546 Screwdriver, flat tip ¼" X 2" HP 69 1 5120-01-335-8556 Screwdriver, flat tip 1/8" X 4" HP 70 1 5120-01-335-8558 Screwdriver, flat tip 1/8" X 8"HP 71 1 5120-01-335-8560 Screwdriver, flat tip 3/16" X 3" HP 72 1 5120-01-335-8564 Screwdriver, flat tip 3/32" X 2" HP 73 1 5120-01-335-3639 Tool case, portable 73a 1 5340-01-346-7462 Pad lock (Part of case #73) 74 1 5210-00-031-1504 Gage, gap setting 75 1 5210-00-078-3905 Tape, measuring, 12 ft 76 1 5210-00-223-9604 Level, pocket 77 1 5210-00-234-5223 Rule, steel, machinists, 6" 78 1 6230-01-115-2019 Flashlight, penlight (disposable) 79 1 6625-00-489-3700 Receptacle circuit tester 80 1 6625-01-101-1766 Test lead kit 81 1 6625-01-168-6856 Multimeter 82 1 7920-01-127-4376 Brush, wire, scratch
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65 -- Small, portable medical oxygen generation systems. The preferred system will include a battery power source, external power capability and the capability to restart the system and control oxygen flow rates.