SOLICITATION NOTICE
65 -- ladarwave; custom cornea wavefront syst
- Notice Date
- 8/25/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1 38400 Bob Wilson Drive, San Diego, CA, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- N00295-03-T-0092
- Response Due
- 8/27/2003
- Archive Date
- 9/11/2003
- Point of Contact
- Patricia Hargis, Purchasing Agent, Phone 619-532-8110, Fax 619-532-5596, - Frank Aspuria, Supervisory Contract Specialist, Phone 619-532-8093, Fax 619-532-5596,
- E-Mail Address
-
pjhargis@nmcsd.med.navy.mil, fcaspuria@nmcsd.med.navy.mil
- Description
- The proposed contract action is for supplies or services for which the Naval Medical Center San Diego intends to solicit from only one source, Alcon Laboratories, 6201 South Freeway, Fort Worth, Texas under the authority of FAR 6.302. Interested contractors/persons may identify their interest and capability to respond to the requirement or submit quotations. This notice of intent is not a request for competitive quotations. However, all quotes received August 27, 2003 @ 2:30 p.m. Pacific Standard time, will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-03-T-0092 is issued as a request for quotation (RFQ). Clin 0001.Custom Cornea Wave, Custom Cornea Wavefront System. This requirement is for a wavefront measurement device for use with a government owned Alcon Ladarvision machine. This machine uses a Hartman-Shack based wavefront measurement to determine the aberrations in a human eye including classical refractive errors, coma, spherical and higher order aberrations. The resulting description of these wavefront errors is displayed graphically and described mathematically. Configuration Requirements are: ? Line voltages from 100 - 240 volts AC, +/-10%, RMS, 50 or 60Hz, +/-5%. ? Measurement range without additional aberrations: +8 D to -14 D maximum curvature in any meridian for a 2.5 - 8 mm diameter pupil. ? Astigmatism: Valid measurement data for up to 8D maximum curvature difference between two meridians separated by 90? ? Sphere and cylinder accuracy: Magnitude of error in measurements shall be less than 1% or 0.05D, whichever is larger. ? Generate a mathematical description of the measured wavefront shape, and display graphical image of the measured wavefront. ? Calculate the effective clinical prescription (sphere, cylinder axis) from the wavefront data, compute how well the wavefront can be described by spherical and cylindrical powers, and shall present this information to the operator. ? Display the real-time Hartmann-Shack image whenever the probe beam is active. ? Automatically process wavefront images. ? The number of images comprising a measurement session shall be a password-protected, software configurable parameter. ? For eyes where centration has been performed, display the frozen video image of each measurement to the operator. ? Determine the position of the limbus relative to the instrument optical axis with an accuracy of +/-0.1 mm, 2 sigma. ? Incorporate a floppy drive for data transfer to other systems. ? Patient details (including patient name and identification number), measurement data and eye registration information can to be written to the floppy disk. ? System design shall accommodate wheel chair patients. ? Power delivered to the eye shall be controlled to within the predefined eye-safe limit as defined in ANSI Z136.1-2000 American National Standard and IEC TR60826-9. ? The power circuit shall have overdrive shutdown protection in case the primary circuit has component failure. ? Headrest and chinrest shall use low absorption thermoplastic materials and withstand cleaning with isopropyl alcohol ? Shall satisfy the International Medical Devices Directive Classification 93/42/EEC and be CE approved for international sales. The product shall must comply with the following standards: EN 60601-1, EN 60601-1-1, EN 60601-1-2 CISPR 11 (Emission) - Class A IEC 801-2, IEC 801-3, IEC 801-4, IEC 801-5. EN 60601-1-4, EN 1041, EN 1441 ? Software shall have two defined modes for diagnostic wavefront measurement and FDA approved surgery use and provide for both positive and negative cylinder conventions ? The GUI shall provide the capability of determining and recording eye registration information for use with the Laser tracking system. ? The LADARWave shall automatically fog the patient by presenting the fixation target beyond the patient's far point by an amount that is configurable under password protection. ? Eye illumination lights at 940 nm and 520nm wavelengths, and shall not interfere with simultaneous wavefront measurements. ? The intensity of the eye illumination lights shall be preset but shall be configurable by persons with password access. ? Push button switches for activating image capture accepting or rejecting captured images. ? Left/right eye sensing providing fail-safe identification of the eye. Single point failure shall not produce erroneous indications of the eye under test. Detection of a failure shall terminate the measurement sequence. The system shall not make measurements if there is a mismatch between the selected eye and the head alignment. ? Fogging of the eye shall be performed in less than 15 seconds. ? Optometer (fixation path optics) capable of neutralizing -20D to +19D spherical equivalent and 6D of astigmatism, at any angle from 0 through 179 degrees. ? Optometer spherical equivalent accuracy 1/4D from -10D to +10D, 1/2D between +/- 10D and +/- 15D, and 1D outside that range. ? Optometer cylinder accuracy +/-0.125D in magnitude +/-3degrees in axis. Measurements: ? 85 cm wide by 120 cm long by 150 cm high, with measurement module dimensions of 610 +/-50 mm (L) x 420 +/-50 mm (W) x 475 +/-50 mm (H) ? The weight of the LADARWave shall not exceed 135 Kg. The system shall operate under the following atmospheric conditions: ? Ambient temperature: +15 to +30C High accuracy ? Ambient temperature: +10 to +40C Operational with degraded accuracy ? Relative humidity: 30% to 75% ? Atmospheric pressure: 700 to 1060 hPa (70 to 106 kPa) The instrument will withstand the following transport and storage conditions without damage or performance deterioration: ? Ambient temperature: -40 to +70?C ? Relative humidity: 10% to 100% including condensation PART NUMBER: 8065990310 Location; Naval Training Center, 34800 Bob Wilson Drive, San Diego, CA 92134. The solicitation document and incorporated provisions and clauses are those in effect through FAC 2001-15. This acquisition incorporates the following FAR clauses: 52.212-1 Instruction to Offers- Commercial Item (Oct1995): 52.212-3 Offeror representations and certification - Commercial Items (Oct1995) must be completed and submitted along with the quote (Please contact Patty Jo Hargis 619-532-8083), e-mail pjhargis@nmcsd.med.navy.mil, if a copy is needed; in accordance with 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Aug1996) the following clauses are incorporated by reference in paragraph (a) 52.233-3 Protest after Award (31 U.S.C. 3533) paragraph (b): 52.222-26 Equal Opportunity (E.O.11246); 52.222-21 Prohibition of Segregated Facilities 52.222-35 Affirmative Action for Special Disabled and Vietnam ERA Veteran (28U.S.C.4212); 52.222-37 Employment Reports on Special Disabled Veterans and Veterans of the Vietnam ERA (38 U.S.C.4212), 52.222-36 Affirmative Action for Handicapped Workers (29 U.S.C. 793), 52.212-4 Contract terms and conditions Commercial Items (OST 95). 52.232-36 Payment by Third Party (31 U.S.C. 3332) , 52.212-2, Evaluation - Commercial Items (1999), 52.211-6, Brand Name or Equal (Aug 1999). 52.252-2, Clauses Incorporated by References (Feb 1998) DFARS 252.204-7004, Required central contractor Registration (MAR 1989); DFARS 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Order Applicable to Defense Acquisitions of Commercial Item (APR2003), SIC: 3841, NAICS 339112. This soliicitation is unresticted procurement. All interested Bidders must submit quotation plus product specification to Patty Jo Hargis, Naval Medical Center San Diego, Material Management Dept., Acquisitions Division, 34800 Bob Wilson Drive, San Diego, CA 92134, or by FAX (619) 532-5596 or by e-mail pjhargis@nmcsd.med.navy.mil. All quotation must be received by August 27, 2003, @ 2:30 p.m. Pacific Standard time to be considered responsive.
- Place of Performance
- Address: Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134
- Zip Code: 92134
- Country: United States
- Zip Code: 92134
- Record
- SN00411704-W 20030827/030825213917 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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