MODIFICATION
65 -- Attach 1 Spec VA-263-07-RQ-0110
- Notice Date
- 7/30/2007
- Notice Type
- Modification
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Veterans Affairs;VA Midwest Health Care System;Attention: Network Contract Manager;One Veterans Drive, Building 68;Minneapolis MN 55417
- ZIP Code
- 55417
- Solicitation Number
- VA-263-07-RQ-0110
- Response Due
- 8/6/2007
- Archive Date
- 10/5/2007
- Small Business Set-Aside
- N/A
- Description
- ATTACHMENT 1 VA-263-07-RQ 0110 Product Description: Cataract Extraction Units - Phacoemulsification systems are used to break up and remove cataractous lenses of the eye. A cataract is a foggy area in the normally transparent lens, which inhibits the transmission of light to the retina and causes a painless blurring of vision. Phacoemulsification is widely used by ophthalmic surgeons because the entire procedure - cataract extraction and implantation of an intraocular lens - can be done through a single small incision that may help control and reduce surgically induced astigmatism, quicken visual rehabilitation, and decrease surgical complications. Functional Requirements: Requirements Description Operational Modes The Phaco Emulsifier Unit shall include the following modes of operation: " Irrigation " Irrigation/Aspiration " Ultrasound " Diathermy " Vitrectomy HandPiece Type The Phacoemulsification system shall include seven (7) hand pieces, which meet the following requirements: " Material - Hand pieces shall be constructed of an autoclavable titanium. " Weight - Hand pieces shall be light weight. Less than 5 oz (142 g). " Frequency - Hand pieces shall use a piezoelectric transducer to vibrate the hand piece tips at a frequency between 25 and 80 kHz. Handpieces type shall also include aqualase liquefaction technology. " Modes - Hand pieces shall posses a Pulse Mode Irrigation/Aspiration System The Phacoemulsification system shall include a Irrigation/Aspiration (I/A) System with the following functions: " I/A shall include a peristaltic pump capable of 500 mmHg maximum vacuum. " I/A shall include an atmospheric vent(s) " I/A shall includegravity or pump reversal reflux " I/A shall include autoclavable ports with diameters between 0.2 and 0.5 mm. Foot Control The Phacoemulsification system shall be operational via remote (foot) control. The spare foot control shall also be provided. Biomed staff will store the spare foot control. Warranty The vendor shall provide details of standard warranty. In addition, vendor shall indicate availability and cost of extended parts warranty options. Trade-In The vendor seller shall provide trade-in values (or other promotional initiatives) for the following phacoemulsification system: " Alcon Labs - Series 20000 Legacy. Service and Operator Manuals The vendor shall provide the following documentation for the proposed system: 1. Two copies of the Operator 's Manual. 2. Two copies of complete technical service manuals including troubleshooting guides, necessary diagnostic software and equipment, schematic diagrams, and parts lists. On-Site User Training Qualified instructors must provide user training. Training shall be for an appropriate, standard period of time for the equipment. Vendor shall provide a description of the user training planned. Other purchase considerations include: " Construction Quality - 1. The equipment should have no sharp edges. 2. All external components should be securely mounted. 3. The equipment should be secure and provide adequate protection against moving and electrically energized parts. 4. The equipment should be well constructed with durable materials to withstand typical abuse and cleaning. 5. Switches, knobs, and other controls should be designed for conditions of heavy use. 6. Connections should be secure to resist accidental disconnection and should maintain sterility, when appropriate. " Controls - 1. The controls (e.g., switches, knobs) should be visible and clearly identified, and their function should be self-evident. 2. Device design should prevent misinterpretation of displays and control settings. 3. Switches and controls should be protected against accidental setting changes (i.e., due to someone brushing against the panel). 4. Controls should be sealed against penetration of liquids. " Labeling - 1. Labels and markings should be clear and legible. 2. Labels and markings should be durable enough to withstand routine cleaning and normal wear. 3. Appropriate warning labels should be provided on the equipment. " Ease of Use- 1. The equipment should be simple to use, operate, and maintain. 2. Abbreviated operating instructions should be included on or with the equipment. 3. The equipment should be easy to clean, disinfect, and/or sterilize, as appropriate. 4. The equipment should be designed to provide easy access to serviceable parts.
- Record
- SN01356200-W 20070801/070730220643 (fbodaily.com)
- Source
-
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