Attachment C - Compliance Spreadsheet1.xlsx
XLSX spreadsheet 18 KB Posted
- Solicitation number
- SPE2D1-24-R-0002
About this file
This document is an attachment to a federal Request for Proposal (RFP) for an Aeromedically Certified Suction Apparatus. It outlines the compliance requirements and key system attributes for the proposed suction apparatus, including operating modes, power sources, control features, performance characteristics, environmental requirements, maintenance and training specifications, and warranty terms.
The suction apparatus must possess Joint (Dual) Airworthiness Certification (JAC) consisting of a Safe to Fly (STF) letter from the U.S. Air Force for fixed-wing aircraft, and a Fleet Airworthiness Release (AWR) and Aeromedical Certification letter from the U.S. Army for rotary aircraft. Key performance parameters include the ability to operate in continuous and intermittent suction modes, adjustable vacuum ranges, extended battery life, and ruggedness to withstand transportation and environmental stresses. The device must be maintainable by military biomedical technicians using standard tools and diagnostic equipment. Vendors must provide training materials, support parts and consumables, and comply with Trade Agreement Act (TAA) requirements.
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| File | Type | Posted |
|---|---|---|
| SF1449_SPE2D124R0002.PDF | ||
| Attachment A.pdf | ||
| Attachment B - MediPrice Template.xlsx | XLSX spreadsheet |
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Sheet1
| Please use the following compliance codes when respond in this column ("COMPLIES"): C- Current 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 offered. | ||||||
| Essential Characteristic | Threshold (T) | Objective (O) | Complies | Explanation of conformance or nonconformance with proposal reference | ||
| 1.00 | Key Performance Parameters | |||||
| 1.01 | Shall be able to operate in both continuous and intermittent suction modes. | YES | T=O | |||
| 1.02 | The apparatus shall be capable of operating from multiple power sources including a component battery. Shall be capable of operating from any of the specified external AC or DC power sources while the internal battery is being recharged via the component battery charging circuit. Simultaneous operation and recharge shall not effect recharge time. | Shall operate from 110~240 VAC, 50/60 Hz, and an internal rechargeable battery. Automatic switching between these power sources is strongly preferred. | Shall operate from 110˜240 VAC, 50/60/400 Hz and 12-28 VDC, and an internal rechargeable battery. Automatic switching between these power sources is strongly preferred. | |||
| 1.03 | Vendor shall provide the option of power plug adapters. | YES | T=O | |||
| 1.04 | The unit must have an integral battery charger and operate and charge at the same time. | YES | T=O | |||
| 1.05 | Shall have FDA Clearance and comply with applicable sections of title 21, Code of Federal Regulations (21 CFR). | YES | T=O | |||
| 1.06 | Controls for the device shall include: Mode control switch - off/continuous/intermittent, On Time Selector Control - Continuously variable, Off Time Selector Control, Vacuum Adjust Control , AC/DC Voltage Protector , and a Safety Lockout | Controls for the device shall include: Mode control switch - off/continuous/intermittent, On Time Selector Control - Continuously variable, at least 5 thru 40 seconds, Off Time Selector Control - Continuously variable, at least 5 thru 40 seconds at all combinations, Vacuum Adjust Control - Continuously variable over the low and high ranges, AC/DC Voltage Protector - Fuse or circuit breaker, and a Safety Lockout - No intermittent suction in high range | T=O | |||
| 2.00 | Key System Attributes | |||||
| 2.01 | Shall be in compliance with the Trades Agreement Act (TAA) | YES | T=O | |||
| 2.02 | Shall be able to perform suctioning for the following clinical applications: | |||||
| oropharyngeal, tracheal, wound draining and abdominal/thoracic decompression. | YES | T=O | ||||
| 2.03 | The suction apparatus shall provide two adjustable ranges of vacuum. | The low range shall be adjustable from 10 to a maximum of 200 mmHg for intermittent suction procedures. The high range shall be adjustable from 0 to at least 550 mmHg for continuous high vacuum procedures. | T=O | |||
| 2.04 | Device must run continuously on battery power on a single charge on max suction | 2 hrs | 6 hrs |
(System being used during ground transportation, extended lines of evacuation and speed will require systems to last longer. Ground platforms do not have the electrical capacity to manage charging needs en route.)
| 2.05 | Device must fully charge (> = 90 %) a depleted battery | 6 hrs | 4 hrs | |
| 2.06 | Must have spare power adapter | NO | YES | |
| 2.07 | Device must have a battery capacity gauge | YES | T=O | |
| 2.08 | Device must have battery shelf Life | 2 years connected/4 years not connected | T=O | |
| 2.09 | Certificate of Airworthiness prior to final selection. (Guidance's involved concerning airspace equipment are the following: AFMAN 10-2909, DAFI 48-107, AFMAN 11-2AE (Checklist), AFMAN 11-2AE Vol 1 to 3.) | Device shall have a Joint Airworthiness Certification (JAC) consisting of a safe-to-fly letter from the U.S. Air Force (for Fixed and Rotary Wing), Fleet Airworthiness Release (AWR) and an Aeromedical Certification Letter (AWC) from the U.S. Army. (Above testing results are not required prior to being considered for submission by vendor) | T=O | |
| 2.10 | The Device shall have Operational and Storage temperature ranges within allowable limits for cold and hot storage and operational environments per Joint Enroute Care Equipment Test Standard (JECETS) which specifies temperature limits and specifies using the test methods in 810G for Tactical-Standby to Operational environmental Tests. | Yes | T=O | |
| 2.11 | Securing of device while operational | Device must be operational while secured vertically and horizontally with accessibility of controls | T=O | |
| 2.12 | Pressure adjustment - Pediatric to Adult | Continuous pressure must be adjustable. Must be = to or > than 550 mmHg , adjustable "0" to maximum settings | Greater than 600mmHg | |
| 2.13 | Vacuum Measurement | Must be able to measure vacuum in mmHg within 10% of indicated rate | T=O | |
| 2.14 | Device must have a suction gauge. | Amount of negative suction provided by device will be easily discernable to the operator. Numeric Negative suction displayed, preferred digitally. | T=0 Amount of negative suction provided by device will be easily discernable to the operator. | |
| 2.15 | Flow Rate Vacuum | Flow rate at max vacuum, liters per minute of air = 30 | Greater than 30 | |
| 2.16 | Intermittent pressure adjustability | The pressure range should be from 10 to 200 mmHg | T=O | |
| 2.17 | Device must be able to accommodate adult patients | YES | T=O | |
| 2.18 | Device must be able to accommodate pediatric patients | YES | T=O | |
| 2.19 | The Device shall have visual and audible alarms with the ability to silence active alarms and all-alarm suspension; silence duration in seconds configurable by user. Active alarm visual indicators must remain visible while audible alarm is silenced. | Alarm conformance IAW IEC 60601-1-8, Medical Electrical Equipment - General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. The high and low alarm limits shall be independently adjustable and read on the display. | T=O | |
| 2.20 | Low-light and NVG compatible | The Device display should have low-light and NVG compatible modalities. | T=O | |
| 2.21 | Equipment Weight | Less than or equal to 10lbs | 5lbs | |
| 2.22 | Device must be one handed carry with accessories / supplies | YES | T=O | |
| 2.23 | Shall have a portable configuration, with the ability to be mounted onto a IV pole or rail. Shall have the ability to be secured to a standard NATO litter and SMEED. | YES | T=O | |
| 2.24 | Device must have operating temperature range | 0 degrees Fahrenheit to 120 degrees Fahrenheit | Minus 25 to 150 Fahrenheit | |
| 2.25 | Shall be ruggedized to withstand transportation over secondary roads and cross country. Will be validated via Environmental Testing events: Transit Drop and Road Shock & Vibration testing in accordance to MIL STD 810G. Airworthiness assessment will be conducted in accordance to the JECETS standard. | YES | T=O | |
| 2.26 | Device must be impact resistant /durable. Drop tests are performed to assure that the device can withstand the drop shocks that may be encountered in handling, transportation, and service environments. | safe operation after a 3 foot drop | safe operation after a 6 foot drop | |
| 2.27 | Must have pump contamination prevention | Bacterial filter between the canister and the pump. | Hydrophobic filter between the canister and the pump. | |
| 2.28 | Must be water resistant | YES | T=O | |
| 2.29 | Must operate at low noise level | Shall not exceed 60dbA for high and 50dbA for low vacuum (@ one meter from all sides) | Less than 40 dbA for high vacuum and 30 dbA for low vacuum (@ one meter from all sides) | |
| 2.30 | Device and canister must have back flow prevention | YES | T=O | |
| 2.31 | Collection canisters | Canister for apparatus shall be able to contain up to 2000mL, and apparatus shall be capable of holding a reusable or disposable canister. Collection canisters shall be configurable to operate singly or in tandem with one another. Each canister shall include an overflow shutoff valve cartridge that can be removed and reinstalled without the use of tools to facilitate and make possible tandem use. Collection canisters shall be constructed from clear, non-breakable, autoclavable material if reusable. Canister lids shall be self-sealing to prevent leakage. | Canister lids shall be self-sealing to prevent leakage and be autoclavable. Tube fittings and the overflow shutoff valve cartridge and any other components comprising the complete collection canister/lid assembly shall be autoclavable if reusable. Disposable canisters will be collapsible to save space during storage. Device can accept multiple size canisters from 200 ml to 2000ml. | |
| 2.32 | As an optional capability, a vehicle power cord assembly shall be provided, at least 4 feet in length, having a vehicle cigar lighter plug on one end and a mating suction apparatus plug on the other end | NO | YES | |
| 2.33 | Vendor Provided Training | Vendor must provide initial training via classroom, cd, online | T=O | |
| 2.34 | Vendor will provide training materials for users on new functionality and enhancements | YES | T=O | |
| 2.35 | Vendor must provide alternative training methods utilizing the latest distance learning technology | YES | T=O | |
| 2.36 | Training material must either be CD or manuals. | YES | T=O | |
| 2.37 | Shall contain two (2) sets of operating/maintenance manuals. (Service manual will include theory of operation, trouble shooting, all maintenance and calibration requirements, illustrated parts breakdown (IPB) with part numbers for each replaceable component, all applicable schematics [electronic, pneumatic, hydraulic, etc]; manuals will be the same as provided to OEM service engineers). | Electronic and hard copy | T=O | |
| 2.38 | Shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government SMEs). The country of origin, availability, proprietary parts, and purchaseability of each item shall be provided on the list. Requirements for these items would be solicited under separate delivery orders issued in accordance with FAR Part 16.5. | YES | T=O | |
| 2.39 | Consumables must be non-proprietary / universal | YES | T=O | |
| 2.40 | Shall provide a full listing of consumables, accessories and optional items. The country of origin, availability, proprietary parts, and purchaseability of each item shall be provided on the list. Requirements for these items would be solicited under separate delivery orders issued in accordance with FAR Part 16.5. | YES | T=O | |
| 2.41 | Shall agree to support all repair parts, accessories, consumables and optional items under their existing IDIQ contract. Shall indicate which items are on their IDIQ contract and shall agree to add those items that are not currently on their IDIQ contract prior to delivery order selection under this RFQ. This includes agreement to add the items on the DLA Electronic Catalog (ECAT) for direct online ordering by DLA customers, if implemented by DLA. For those items listed as not on contract and which are TAA compliant, the vendor must provide an acceptable contract addition request along with their proposal. Any such items that cannot be added to the IDIQ contract (i.e. pricing cannot be determined as fair and reasonable, etc.) may result in rejection of the quote. | YES | T=O | |
| 2.42 | Shall allow biomed personnel who maintain the equipment and the unit supply/logistics support personnel to contact manufacturer to request information, verify, and order supplies as required (i.e. Fed-ex, or DHL, or UPS tracking Number) | YES | T=O | |
| 2.43 | Device must be able to be cleaned and disinfected with a solution in accordance with Medical Infection Prevention and Control Program guidance Per AFI 44-108 Infection Control Program | YES | T=O | |
| 2.44 | Must have manufacture warranty | 2 years. | ||
| Shall provide a manufacturer warranty for all Parts and In-House Labor and Technical Support during the warranty period. Operator / maintainer telephone support shall be provided 24 hours per day, 7 days per week for the entire life of the system. | 5 years | |||
| 2.45 | Maintainability at military location with Vendor training to military personnel | The Device shall be maintainable by military or civilian BMETs using standard tools (as provided in standard BMET kit; no special tools required), using non-proprietary diagnostic equipment (TMDE) 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. | T=O | |
| 2.46 | Device system software shall be upgradeable in the field by military Biomedical Repair Technicians, with or without internet connection, using a computer interface, the internet or a CD supplied by the OEM without requiring changing hardware components of the device; OEM shall provide notification of product software modifications and/or updates to customer and outdated software shall not render the device unusable | Device system software that may require modification during system life shall be upgradable in the field by military BMETs using a computer interface , the Internet, or a CD supplied by the manufacturer without changing hardware components of the device. Manufacturer notification of product software modification and/or updates sold to customers is required. | T=O | |
| 2.47 | The Device shall have Shipping and Storage temperature ranges within allowable limits for cold and hot storage and operational environments per Joint Enroute Care Equipment Test Standard (JECETS) which specifies temperature limits and specifies using the test methods in 810G for Tactical-Standby to Operational environmental Tests. | Conforms to Joint Enroute Care Equipment Test Standard (JECETS) via MIL-STD-810G requirements. | T=O | |
| 2.48 | OEM Service and Operator manuals shall contain the current DoD Performance Specification (MIL-PRF- 32216A) EVALUATION OF COMMERCIAL OFF- THE-SHELF (COTS) MANUALS AND PREPARATION OF SUPPLEMENTAL DATA. | YES | T=O | |
| 2.49 | Vendor must notify the Defense Logistics Agency and Services Points of Contact of all field change orders, alerts, recalls and equipment notices affecting the system for the life cycle of the system. | YES | T=O | |
| 2.50 | The system shall have Unique Item Identification markings in compliance with DFARS 252.211-7003 | Yes | T=O | |
| Vendor point of contact: | ||||
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| Job title: | ||||
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| Email address: |
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