Exhibit A Anterior Vitrectomy System - Requirements Matrix.xlsx
XLSX spreadsheet 15 KB Posted
- Attached to
- Anterior Vitrectomy System Federal contract opportunity
- Solicitation number
- W81XWH20Q0070
- Issued by
- Department of the Army Medical Command
About this file
This combined synopsis/solicitation document requests quotations for an anterior vitrectomy system to fulfill a requirement of the U.S. Army Medical Materiel Development Activity. The end item must be a small, lightweight, portable, durable, and reliable system capable of operation in forward field hospital settings. Interested offerors must submit proposals by May 14, 2020. Award will be made on a competitive basis using tradeoff procedures. The solicitation is open to all interested parties on an unrestricted basis and is not set aside for small businesses. The North American Industry Classification code is 339115 and size standard is 1,000 employees. The point of contact for any questions is Brandon Roebuck at the email address provided.
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Other files for this federal contract opportunity
| File | Type | Posted |
|---|---|---|
| Questions for Anterior Vitrectomy System REVISED 51320.docx | DOCX document | |
| Combined Synopsis_Solicitation Vitrectomy System REVISED 4302020.docx | DOCX document | |
| Questions for Anterior Vitrectomy System.docx | DOCX document | |
| Appendix A - Cybersecurity Evaluation Example Questions.pdf | ||
| Exhibit B - Pricing Sheet.xlsx | XLSX spreadsheet | |
| Combined Synopsis_Solicitation Vitrectomy System.pdf |
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Text version
Sheet1
| Requirements | Offeror Instruction | Offeror Input | |||
| Army Requirement | Minimum Essential Characteristic | Objective | Offeror Qualification | ||
| [Offeror enter data here] | Reference Location |
[provide reference document and location to confirm qualification]
FDA Clearance Shall have FDA 510k approval for use in ophthalmic surgery. N/A Please confirm that the device is approved by the FDA.
Provide FDA approval date.
| Vitrector Cutting Speed | Shall include vitrector which utilizes speeds of at least 2000 cuts per minute (cpm). | Vitrector speeds up to 2500 cuts per minute (cpm). | Please indicate the vitrector's cutting speed in cuts per minute (cpm). |
| Trocar/Surgical Wound Diameter | The minimum trocar/surgical diameter shall be at least 23 gauge. | Trocar/surgical diameter 27 gauge. | Please indicate your device's trocar/surgical gauge. |
| Console | Shall have a console for powering and controlling the device functions. | N/A | Please provide details on the vitrector's physical controls and console. |
| Foot Switch | Shall have a multifunction foot switch to operate the functions of the system. | N/A | Please confirm that the vitrector has a foot switch. |
Provide details of functions controlled by foot switch.
Ruggedized case(s) System shall be packed in ruggedized case(s) for transport and storage Ability to store items (non-operating) in their ruggedized cases up to 140oF, up to 90% Rh, and able to survive shock and/or jarring that would be typical of transport. Please indicate Min/Max temperature range – operating, and Min/Max temperature range - storage.
| Aspiration Vacuum Range | The aspiration vacuum should have a minimum range encompassing 30 mmHg to 600 mmHg. | N/A | Please provide the aspiration vacuum pressure in millimeters of mercury (mmHg). | |
| Phacoemulsification capability | The unit should have phacoemulsification capability. | N/A | Please note whether or not the device has phacoemulsification capability. If so, please provide the specifications. | |
| Shipping Cube | The total system in its cases should not exceed approximately 1.0 cu m (35.3 cubic ft). | Not exceed approximately 0.3 cu m (10.6 cubic ft). | Please provide the dimensions of the transport case(s) containing the device as packed for transport. | |
| System Weight | 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. | Not exceed 50 lbs. | Please provide the total weight of the device and all of its components in the case. |
If more than one case is needed, provide details for each.
| Ophthalmic Diathermy | Unit should include an embedded diathermy unit. | N/A | Please note whether the device has an embedded diathermy unit. If so, please provide the specifications. |
| Power Requirements | System should be able to operate on standard 110/220V, 50/60 Hz power supplies. | N/A | Please supply the device's operating power requirements and typical power consumption. |
| Manuals | Two copies each of Users' and Maintainers' manuals shall be included with each system. | |||
| Electronic copies of manuals must be made available. | Please confirm manuals will be provided with equipment. | |||
| Ancillary Items | - Information Requested - | N/A | Please indicate what ancillary items are needed (ex. Power cords, vacuum etc.) | |
| Maintenance | - Information Requested - | N/A | • Please provide high level summary of anticipated maintenance actions and frequency. |
• Please indicate any unique tools or equipment needed for preventive or corrective maintenance.
Electronics - Information Requested - N/A • Electronic Storage: Is job information stored electronically on the unit? If yes, are job details user selectable? (Intent is to NOT store PHI/PII)
• Updates: Will electronics require periodic update? If yes, what frequency is expected, and what is method for update?
| Customer Support | - Information Requested - | N/A | What are hours of availability for technical support? |
| Production lead-time | - Information Requested - | N/A | What is your lead-time for delivery of equipment for use as test articles? |
What is your typical production lead-time, and any min/max order constraints?
(END)
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