RFI_Vitrectomy_Response_Spreadsheet.xlsx
XLSX spreadsheet 17 KB Posted
- Attached to
- Request For Information Vitrectomy System
- Solicitation number
- Vitrectomy_RFI_2018
- Issued by
-
Department of the Army Medical Command
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Vendor Response excel spreadsheet
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| File | Type | Posted |
|---|---|---|
| RFI_Vitrectomy_USAMMA.pdf |
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Sheet1
| Requirement | Definition | Vendor Compliant (Yes/No/Partial) | Vendors Comments | Location of Supporting Documentation |
| Essential Characteristics (EC) | These characteristics are essential and must be met in order for the device to be considered acceptable. They may be subdivided into a threshold (T) and an objective (O). The threshold (T) is the minimum acceptable value while the objective is a desired level of performance above the threshold. | |||
| FDA Clearance | Shall have FDA 510k approval for use in ophthalmic surgery (T) | |||
| Aspiration Vacuum Range | The aspiration vacuum shall have a minimum range encompassing 25 mmHg to 600 mmHg (T) | |||
| Vitrector Cutting Speed | Shall include a high speed vitrector which utilizes speeds up to 5000 cuts per minute (cpm) (T) or utilize equivalent alternative technology such as hypersonic technology (O) | |||
| Trocar/Surgical Wound Diameter | The trocar/surgical diameter shall have a minimum range encompassing 23-25 gauge (T) | |||
| Pressure Range | Shall operate on a range of pressures of approximately 70 to 120 PSI with no gases other than medical air or nitrogen (T) or utilize alternative technologies that provide equivalent or superior clinical results with no gases required (O) | |||
| Light Source | Shall have an integrated light source (T) to illuminate the eye during vitreoretinal procedures or LED is the preferred light source (O) | |||
| Fluid Transfer System | Shall permit the replacement of vitreous fluid with filtered air (T) | |||
| Additional Performance Parameter (APP) | These are additional desired performance parameters but not essential. They allow for technical trade space and assist in best value determination. If these areas of support are met, they will be rated as strengths and if unavailable as weaknesses. | |||
| Console | Shall have a console for powering and controlling the device functions. | |||
| Ophthalmic Diathermy | Unit shall include an embedded diathermy unit | |||
| Foot Switch | Shall have a multifunction foot switch to operate the functions of the system | |||
| System Weight | The total system in its cases shall not exceed 200 lbs | |||
| Shipping Cube | The total system in its cases shall not exceed approximately 1.36 cu m (48 cu ft) | |||
| Trocar/Surgical Diameter | Shall include 27 gauge surgical/wound diameter | |||
| Laser | Shall include an integrated laser capability | |||
| Fragmatome | Shall include an integrated fragmatome | |||
| Integrated Expansile Gas | Shall include integrated expansile gas capability (C3F8/SF6) delivery | |||
| Fluid Delivery | Shall include an integrated viscous fluid delivery/removal capability | |||
| Integrated Logistics Support (ILS) Elements | These are areas of desired support including logistics, maintenance, training, parts, and others which allow for the sustainment of the device during storage, transport, and use. They allow for technical trade space and assist in best value determination. If these areas of support are met, they will be rated as strengths and if unavailable as weaknesses. | |||
| ILS Supply Support | ||||
| Accessories and Consumables Support | Vendor shall provide a full listing of consumables, accessories, and optional items. This listing shall include a description, part number, and pricing. It is desirable for these items to be placed on a procurement contract allowing for rapid purchase. These items must be available for procurement throughout the useful life of the system. | |||
| Repair Parts Support | Vendors shall provide a full listing of repair parts. The list must provide the country of origin and identify any high failure rate parts. This listing shall include a description, part number, and pricing. It is desirable for these items to be placed on a procurement contract allowing for rapid purchase. These items must be available for procurement throughout the useful life of the system. | |||
| Obsolescence | The vendor shall notify the USAMMA and DLA that their system and/or parts are coming to the end of useful life, or that they are no longer available for procurement within 12 months of such date. System shall be supportable for a minimum of 8 years. | |||
| Parts and Supplies Request | Vendor shall allow DoD personnel, including maintenance and logistics, to contact manufacturer to request information, verify data, and order accessories, consumables, and spare parts as required to support the system throughout the useful life of the system. | |||
| ILS Maintenance Planning | ||||
| Maintenance Concept | Vendor shall work with the USAMMA to develop a maintenance plan that allows the device to be maintained during storage, transport, and use. The maintenance plan should include areas such as inspection, lubrication, cleaning, preventative maintenance, calibration, troubleshooting, diagnostics, software upgrade, security, safety, parts replacement, and repair. System shall be supportable by a combination of Army Biomedical Equipment Specialists (MOS 68A), the Army depot sustainment enterprise, and the manufacturer. | |||
| Warranty | Vendor shall provide a minimum 12 month warranty from time of delivery that includes all parts, software updates, labor, technical support, shipping, and repair during the warranty period. Extended warranty options are desirable. | |||
| Maintenance Agreement, Optional | Vendor shall provide a maintenance agreement option after the warranty expires. The maintenance agreement shall include a variety of levels of support from parts only to full maintenance support. The agreement shall provide specifics as to each level of support, time frames, and costs. | |||
| Software/Firmware Obsolescence | Vendor shall provide a software obsolescence plan for addressing the maintenance of any software that reaches end of life whether company produced or produced by a third party vendor. i.e. Windows XP or WIN7. | |||
| Software/Firmware Support | Vendor shall make available support and upgrades to system software/firmware throughout the life of the system. It is desired that system software upgrades be able to be performed in the field by Biomedical Equipment Specialists (MOS 68A) or remotely over the network. | |||
| Operator and Maintainer Technical Support | Vendor shall provide operator/maintainer telephone technical support during vendor's normal business hours for the useful life of the system. | |||
| Alerts, Recalls and Field Change Order Notifications | Vendor shall notify the government, including DLA and the Services of all field change orders, alerts, recalls and equipment notices affecting the system's effectiveness and/or safety for the useful life of the system. | |||
| ILS Package, Handling, Storage, Transport | ||||
| Transport | Components of the system shall be able to be disassembled for storage and to facilitate transport. The system shall be able to be removed from the case, assembled, and made ready for use by the operator using only the instruction manual. | |||
| System Packaging | The transport cases shall meet the appropriate handle and lifting requirements for the weight and cube of the proposed system, IAW MIL-STD-1472G. | |||
| Transport Case Labeling | Each case shall have a permanent marked data plate with the following information: National Stock Number, Item Unique Identification (IUID), IAW DFARS 252.211-7003, Item Unique Identification and Valuation (MAR 2016), System Nomenclature, and Manufacturer Name. | |||
| Storage Temperature (low) | The system shall be capable of low temperatures storage testing to -33°C (-27.4°F) IAW MIL-STD-810G-502.5: Basic Cold (C1). | |||
| Storage Temperature (high) | The system shall be capable of high temperatures storage testing to +71°C (159.8°F) IAW MIL-STD-810G-501.5: Hot Dry (A1). | |||
| Operational Temperature (low) | The system shall withstand low operating temperatures IAW the OEM technical literature without degradation of performance. | |||
| Operational Temperature (high) | The system shall withstand high operating temperature IAW the OEM technical literature without degradation of performance. | |||
| Loose Cargo Transportation | The system shall be fully operational after being subjected to the shock and vibration encountered during military transport operation. This test will be conducted IAW MIL-STD-810G, Method 514.6 on the device in its packaged shipping container. | |||
| Settling Dust | The system while in its case shall withstand a settling dust environment without degradation of performance. This procedure is performed to ascertain the ability of the test item to resist the effects of dust particles which may penetrate the test item. | |||
| Altitude | The system shall be able to function properly at altitudes of at least 4,572 meters above sea level. Upon test completion, the device is removed from the test chamber, and the post-test validation procedure performed. | |||
| Transit Drop | The system shall remain fully operational after being subjected to drops associated with transportation, in accordance to MIL-STD-810G Test Method 516.6 Procedure IV. | |||
| ILS Technical Data | ||||
| Technical Data Support | Vendor shall provide all operator and maintainer technical literature, with copy-right release. The following shall be provided: One (1) hard copy and one (1) digital copy of the operator and maintenance manuals and one (1) digital copy of the operator and maintenance training materials. Searchable PDF is the preferred format. | |||
| Technical Data Availability | It is desired that the vendor provide access to all technical and training literature via their website. Vendor may create a portal for the DoD for technical support. | |||
| Service Manual and Operator Format | Vendor shall meet the intent of the DoD Performance Specification, MIL-PRF-32216A, Evaluation of Commercial Off-the-Shelf (COTS) Manuals and Preparation of Supplemental Data. | |||
| Technical Data Update | Vendor shall keep the technical literature and training materials up-to-date for the useful life of the system. Updates to the manuals and other technical data shall be made available when released. | |||
| ILS Support Equipment | ||||
| Specialized or Propriety Tools | The vendor shall identify any specialized or proprietary tool requirements. A list of these tools will be provided and include: description, part number, and cost. It is desired that the system be supportable with the standard tools found in a DoD Biomedical Equipment Specialist's tool set. A listing of this set will be provided. | |||
| Specialized or Proprietary Test Measurement Diagnostic Equipment (TMDE) | The vendor shall identify any specialized or proprietary TMDE requirements. A list of these items will be provided and include: description, part number, and cost. It is desired that the system be supportable with the TMDE found in a DoD Biomedical Equipment Specialist's TMDE set. A listing of this TMDE will be provided. | |||
| Specialized or Proprietary Support Equipment | The vendor shall identify any specialized or proprietary support equipment requirements. A list of these items will be provided and include: description, part number, and cost. It is desired that the system be supportable with limited or no specialized support equipment. | |||
| ILS Training and Training Support | ||||
| Maintainer and Operator Training | Vendor shall provide an operator and maintainer training plan. Training topics will include: principles of operation, preparation for use, installation, software applications, startup/shutdown, operating instructions, emergency shutdown, maintenance, servicing instructions, cleaning and lubrication, performance verification, inspection, troubleshooting, software updates and security patch instructions, preparation for shipment and long term storage, safety hazard identification and mitigation, and required tools, test equipment, and consumables. | |||
| Clinical Training Support, Optional | The vendor shall provide the option for additional clinical training that can be procured on an as needed basis. It is desired that this training be on a contract vehicle that will allow for rapid purchase and execution. | |||
| Maintainer Training Support, Optional | The vendor shall provide the option for additional maintenance training that can be procured on an as needed basis. It is desired that this training be on a contract vehicle that will allow for rapid purchase and execution. | |||
| On-line Training Support | It is desired that operator and maintenance training be available on-line. This training can be the comprehensive or abbreviated. It must provide the basic knowledge required to setup, operate, and store the system as well as basic preventive and corrective maintenance procedures. | |||
| ILS Manpower and Personnel | ||||
| System Start-Up | The clinical user shall be able to unpack, setup, and prepare the system for operation using the operator’s manual. | |||
| Device Configuration | The clinical user shall be able to configure the system (i.e. foot control) using the operator’s manual. | |||
| System Preparation for Storage and Transport | The clinical user shall be able to teardown, pack, and prepare the system for transport and storage using the operator’s manual. | |||
| ILS Computer Resources | ||||
| Cybersecurity Testing Requirement (Questionnaire) | Vendor shall provide a completed Cybersecurity Questionnaire with their RFO/RFP response (Government will provide questionnaire). | |||
| Cybersecurity Testing Requirement (Testing) | The vendor shall pass cybersecurity testing prior to starting any performance and delivering any items to the Government. Testing will be based on DoD Instruction 8500.01, “Risk Management Framework (RMF)” (Government will provide all pertinent cybersecurity references). | |||
| Cybersecurity Testing Requirement (Testing Timeline) | Vendor shall adhere to specified cybersecurity timeline and complete cybersecurity testing within 240 working days (Government will provide a timeline for testing). | |||
| Cybersecurity Testing Requirement (Operating System/ Application Software) | Vendor shall provide a system that has an approved operating system by the current RMF guidelines. | |||
| Cybersecurity Testing Requirement (Remote Diagnostic Access) | System shall have the remote diagnostic access capabilities to maintain, support and update software remotely. | |||
| Application Software Licensing | System shall include an enterprise software license that does not require an external device or key (such as a “dongle” or soft key) to operate, update, or maintain the system. |
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