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Requirements Document Critical Operations Device Specifications (CODS) / Critical Logistical Specifications / Additional Performance Parameters (APPs)
Title: Anterior Vitrectomy System
Requiring Activity/ Agency Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Devices (SMD)
Background: The government requires an Anterior Vitrectomy System for use in a deployed settings (Role of Care (ROC) 3). The anterior vitrectomy system is used to remove vitreous bodies, other fluids, and debris from patients’ eyes. The system is used by ophthalmologists and directly contributes to the retention of eyesight. The current anterior vitrectomy system is no longer procurable. As a result, the Army is updating this device to maintain service ability. The government is looking to procure an anterior vitrectomy system that can meet the Army’s needs as described in this document, see below.
Purpose: The government expects to award a single contract for the procurement of five (5) Anterior Vitrectomy System to complete the Army’s requirement.
The Defense Logistics Agency (DLA) Electronic Catalog (ECAT) is a crucial online system used by the Department of Defense and government agencies to procure supplies and equipment. Acting as a centralized online store, ECAT provides access to millions of National Stock Numbers (NSNs) with detailed product information, including descriptions, pricing, and availability. This system streamlines the procurement process, allowing users to easily search for items, place orders, and track shipments, ultimately saving time and money while ensuring all branches have access to the same standardized products. Please access how to do business with ECAT @ https://www.dla.mil/Troop-Support/Medical/ECAT/, for specific questions, recommend contacting the ECAT Help Desk @ dscpecathelp@dla.mil.
1. Critical Operational Device Specifications: The following are essential characteristics, and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
| # |
| Operational Characteristic |
Minimum Required
Desired Characteristics
| 1 |
| FDA Clearance |
| The system shall have FDA 510k approval for use in ophthalmic surgery. |
| Minimum Requirement |
| 2 |
| Vitrector Cutting Speed |
| The system shall include a vitrector which utilizes speeds of at least 2000 cuts per minute (cpm). |
| The system has vitrector speeds up to 2500 cuts per minute (cpm). |
| 3 |
| Trocar/Surgical Wound Diameter |
| The minimum trocar/surgical diameter shall be at least 23 gauge. |
| Trocar/surgical diameter 27 gauge. |
| 4 |
| Console |
| The system shall have a console for powering and controlling the device functions. |
| Minimum Requirement |
| 5 |
| Foot Switch |
| Shall have a multifunction foot switch to operate the functions of the system. |
| Minimum Requirement |
| 6 |
| Aspiration Vacuum Range |
| The aspiration vacuum should have a minimum range encompassing 30 mmHg to 600 mmHg. |
| Minimum Requirement |
| 8 |
| Phacoemulsification capability |
| The unit should have phacoemulsification capability. |
| 9 |
| Ophthalmic Diathermy |
| Unit should include an embedded diathermy unit. |
| 10 |
| Power Requirements |
| System should be able to operate on standard 110/220V, 50/60 Hz power supplies. |
| Minimum Requirement |
Anterior Capability
The system should have capability for anterior, not posterior procedures.
| 12 |
| Vitrector Speeds/Cuts |
| The surgical system should utilize speeds up to 5000, B and L stellari cuts per minute. |
2. Critical Logistic Specifications: The following are essential logistical characteristics, and the minimum must be met to be considered acceptable by the government. They are separated by “minimum” and “desired” column.
Operational Characteristic
Minimum Required
Desired Characteristics
| 1 |
| Trade Agreements Act (TAA) Compliance |
The anterior vitrectomy system and repair parts shall be compliant with TAA regulations.
The vendor must complete the attached TAA compliant sheet Minimum Requirement
| 2 |
| Repair Parts Support |
| The Vendor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list. |
| Minimum Requirement |
| 3 |
| Manuals |
| The vendor shall provide 1 physical and 1 digital User/Operator and 1 physical and 1 digital Maintenance/Service Manual with each system procured. |
| Minimum Requirement |
| 4 |
| Risk Management Framework RMF/ Authority to Operate (ATO) |
| The vendor shall provide supporting documentation as required by the client to complete Risk Management Framework procedures and Authority to Operate activities for cybersecurity protections if deemed relevant |
| Minimum Requirement |
| 5 |
| Copywrite Release |
| The vendors will provide an operational and Maintenance copyright/ distribution release for supporting Army Technical manuals to be distributed throughout the force. |
| Minimum Requirement |
| 6 |
| Ruggedized Case |
| The total system in its cases shall not exceed approximately 1.0 cu m (35.3 cubic ft). |
| Not exceed approximately 0.3 cu m (10.6 cubic ft). |
| The total system in its cases should not exceed approximately 1.0 cu m (35.3 cubic ft). |
| Minimum Requirement |
The total system in its cases should not exceed 70 lbs.
If more than one case is required, no one case may exceed 70 lbs.
Minimum Requirement
| 9 |
| Storage and Shipping |
| The surgical system should have ruggedized case(s) for transport and storage. |
| Minimum Requirement |
| The system and case should have the ability to store items (non-operating) in their ruggedized case up to 140oF and 90% Rh. |
| Minimum Requirement |
| 13 |
| Training |
| The vendor shall provide user and maintenance training for the 9 devices. |
| Minimum Requirement |
| 14 |
| Warranty |
| The vendor shall provide a standard 2 year warranty for the 5 devices and a 1 year warranty after training for the previously procured 4 devices located at MMOD. |
| Minimum Requirement |
3. ADDITIONAL PERFORMANCE PARAMETERS: The below are non-essential additional characteristics that the government desired but not required to be deemed acceptable
| Number |
| Additional Performance Parameters (APPs) |
| Additional Performance Parameters |
| 1 |
| Defense Logistics Agency Electronic Catalog (ECAT) |
| The vendor will work with DLA troop support to get their products on the ECAT contract vehicle for future procurement and make available any service contracts ECAT as well |
| 2 |
| Maintenance kits. |
| If requested by the client, the vendor shall work on creating maintenance kits. |
| 3 |
| Manufacturing capability, order quantities and schedule |
| The vendor will provide information on manufacturing capability to help support the client in understanding supportable order quantities and schedule |
| 4 |
| Test, Measurement, Diagnostic, and Evaluation Equipment |
| The vendor will inform the client if there's any test, measurement, diagnostic, and evaluation equipment associated with the device. |
| 5 |
| Maintenance/service manuals |
| The vendor will, upon request, work with the client on identifying tasks within the maintenance/service manuals that can be conducted by the client and identify which tools are needed. |
***End of Requirements Document***
CUI
Defense Health Agency