Attachment B - Compliance_Checklist.xlsx

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RFI- Aeromedical Certified Ventilator
Solicitation number
SPE2D1-26-RFI-0001
Issued by

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This is a Compliance Checklist for a Request for Information (RFI) solicitation for aeromedical certified portable and transport ventilators issued by the Defense Logistics Agency Troop Support Medical. Vendors must respond with compliance codes indicating whether their products currently comply (C), have planned compliance (P), do not comply (N), or the product is not offered (NA), along with supporting technical documentation and vendor comments.

The required transport ventilator must be FDA-cleared or approved (PMA, 510(k), or legally marketed under 21 CFR 807.97(a)(3)), comply with AAMI MCIP standards (ANSI/AAMI ID26), and hold Joint Airworthiness Certification including a USAF Safe-to-Fly letter and US Army Fleet Airworthiness Release and Aeromedical Certification Letter for use on all military aircraft platforms. The ventilator must serve all patient populations (infant, pediatric, adult) with specifications including tidal volume control of 50-2,000 mL, respiration rate of 0-60 breaths/min, FiO2 of 21-100%, PEEP/CPAP of 0-25 cm H₂O, and support for multiple operating modes including Assist/Control, SIMV, CPAP, and non-invasive ventilation. Physical requirements specify dimensions not exceeding 13"H x 9"W x 5"D and weight not exceeding 13 lbs (with 10 lbs or less preferred), operation on 110-220 VAC (50-60 Hz) with automatic switching and rechargeable internal battery providing 4-10 hours of operation, operating temperature range of 32-104°F, and a ruggedized, de-contaminable carrying case. The device must display comprehensive monitored parameters and alarms, include Night Vision Goggle-compatible display readable in low-light environments, possess an internal air compressor, and transition seamlessly between ambulances and fixed/rotary-wing aircraft without requiring ventilator changes. Vendors must provide initial and distance learning training, two sets of operating and service manuals (electronic and hard copy), one-year minimum manufacturer warranty (two years preferred), maintenance capability by military Biomedical Equipment Technicians using standard tools without voiding warranty, and repair parts availability through ECAT for direct customer ordering.

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Sheet1

Transport Ventilator Detailed Requirement Description
Functional AreaThreshold (T) (Minimum Acceptable)ObjectivePlease include in the vendor response the following compliance codes: C- Current offerred product fully complies; P- Not part of current product but planned in schedule release (Vendor shall indicate the time when the requirement will be available); N- Product does not comply: NA - Product not offeredReferenced Technical literature, and pages in technical literature validating complianceVendor Comments/feedback
Description: Mechanical ventilators provide temporary or permanent ventilatory support for patients who cannot breathe on their own or who require assistance maintaining adequate ventilation because of illness, trauma, congential defects, or the effects of drugs (e.g., anesthetics). A transport ventilator normally consists of a flexible breathing circuit, a control system, a gas supply, and some type of monitoring and alarm system. Portable transport ventilators are designed to take the place of manual ventilation or "bagging" during emergency or transport situations. Portable transport ventilators are well suited for both prehospital and in-hospital applications. Prehospital applications include use in ground and air ambulances and in emergency field hospitals. In healthcare facilities, portable ventilators are used for short term mechanical ventilation and to facilitate transport of ventilator-dependent patients to and from various areas of the facility (e.g., ICU, OR, Radiology).
FDA ClearanceDevice 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) and comply with current versions of the Association for the Advancement of Medical Instrumentation (AAMI) MCIP standards (ANSI/AAMI ID26)T=O
Approved for Aircraft UseShall 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.Proof of this Joint Aeromedical Certification shall be provided with proposal submittal. Shall be acceptable for use during all phases of flight on all military aircraft platforms (including small and large body, fixed and rotary wing) while operating on battery or 110-120VAC 60 Hz in the Aeromedical Evacuation environment. Airworthiness assessment will be conducted in accordance to the JECETS standard.T=O
Shall be used with all ranges of patients (infant, pediatric, adult) and should include an option of closed-loop mechanical ventilation as a safety mechanism for the non-provider operator.Adult, pediatric, infantT=O
Controls
Tidal volume, mL50 - 2,000T=O
Respiration rate, breaths/min0-60T=O
Trigger mechanismPressureT=O
FiO2, %21-100T=O
Inspiratory flow rate, L/min>100T=O
Inspiratory time, sec0 - 2%T=O
Inspiratory pressure, cm H2O10-60, 80 with confirmationT=O
IE ratio1:1 to 1:99T=O
PEEP/CPAP, cm H2O0-25T=O
Pressure support, cm H2O (measured in ref to PEEP)0-60T=O
Panel lockNo - Not necessary / YES is acceptableT=O
Pressure rampYEST=O
Accuracy shall be within +/- 10% of settings for all measured values and controls if not further specifiedYEST=O
Operating Modes
Assist/control modeYEST=O
A/C volume breathsYEST=O
A/C pressure breathsYEST=O
SIMV modeYEST=O
SIMV volume breathsYEST=O
SIMV pressure breathsYEST=O
SIMV pressure supportYEST=O
Spontaneous/CPAP modeYEST=O
CPAP pressure supportYEST=O
Non-invasive ventilationYEST=O
Apnea-backup vent modeYEST=O
Monitored/ Displayed Parameters
Peak inspiratory pressure (PIP)YEST=O
Mean airway pressure (MAP)YEST=O
PEEP pressureYEST=O
Tidal volumeYEST=O
Minute volumeYEST=O
FiO2YEST=O
Respiratory rateYEST=O
Inspiratory timeYEST=O
Expiratory TimeYEST=O
IE ratioYEST=O
O2 in useYEST=O
SpO2YEST=O
Battery %YEST=O
Patient Alarms
Low/high FiO2YEST=O
Low/high minute volumeYEST=O
Low/ high pressureYEST=O
Loss of PEEPYEST=O
High PEEPYEST=O
ApneaYEST=O
Continuous high pressure/occlusionYEST=O
Inverse IEYEST=O
High respiratory rateYEST=O
Breathing circuit disconnectYEST=O
SpO2YEST=O
Equipment Alarms
Gas-supply failureYEST=O
Power failureYEST=O
Vent inoperativeYEST=O
Low batteryYEST=O
Self-diagnosticYEST=O
On-Board Air Compressor
Internal compressorYEST=O
Power Requirements, VAC
Shall be a portable device that operates on 110VAC, 60 Hz and 220VAC, 50 Hz and incorporated rechargeable battery. Automatic switching between these power sources required110v - 220 VAC; 50-60 HzT=O
Rechargeable internal battery4 hr10 hr
Physical Features
Shall have Shipping and Storage temperature ranges of not less than -4°F to 140°F (-20°C to 60°C) and an Operating range of not less than 32°F to 104°F (0°C to 40°C)YEST=O
Shall measure no greater than 13 inches (H), 9 inches (W), and 5 inches (D) (33x23x13 cm)YEST=O
Shall weigh no greater than 13lbs (5.8 Kg)YES10lbs (4.5 Kg) or less
Portable Ventilator display shall be easily readable in low-light environments and Night Vision Goggle compatible and provide Audible and visual alarms in multiple colors according to level of severity allowing continuous visual alarm monitoring by crew during all phases of flight. Consider limitations due to aircraft ambient noise degrading effectiveness of audio alarms.YEST=O
Shall be capable of blending oxygen concentrationYEST=O
Shall include a ruggedized, carrying case that is de-contaminable and designed to prevent damage to the device during operation and transport.YEST=O
Patients are transported by ambulance, Am Bus, rotary wing aircraft and fixed wing aircraft. Ventilator should be applied/ attached to patient at hospital and transition through levels of care without requirement of movement to another ventilatorYEST=O
Training
Vendor must provide initial trainingYEST=O
Vendor must provide alternative training methods utilizing the latest distance learning technologyYEST=O
Vendor will provide training materials for users on new functionality and enhancementsYEST=O
Maintenance
Shall contain two (2) sets of operating and service manualsElectronic and hard copyT=O
Must have manufacture warranty1 year2 years
Device must be able to be cleaned and disinfected with a solution in accordance with infection control guidance Per AFI 44-108 Infection Control ProgramYesT=O
Maintainability at military location with Vendor training to military personnel.The Device shall be maintainable by military Biomedical Equipment Technicians (BMET) using standard tools (as provided in standard BMET kit; no special tools required) without voiding warranty and shall be capable of being cleaned by commonly accepted methods. Repair parts and/or telephone consultation before and after warranty period will be provided to DoD BMETs without need to attend manufacture specific training or incurring additional telephone consultation costs.T=O
The vendor shall include in their proposal all repair parts for the ventilator, and agree to allow the Government to add these parts to the resultant contract(s) and make the parts available on ECAT for direct customer ordering.YesT=O
Vendor point of contact:
Name:
Job title:
Phone:
Email address:

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Sheet3

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