6540--RETeval Electroretinogram CS: Maureen Sundstrom

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

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*= Required Field

Combined Synopsis/Solicitation Notice

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DESCRIPTION

Combined Synopsis/Solicitation Notice

Effective Date: 02/01/2022

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This is a combined synopsis/solicitation for commercial products prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Products, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This is a Brand Name or Equal To Request for Quote (RFQ), and the solicitation number is 36C26023Q0812. The Government anticipates awarding a firm-fixed price supply order from this solicitation.

This is a solicitation for RETeval Electroretinogram. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 Effective June 02, 2023.

This solicitation is 100% set-aside for Small Business. The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 employees and the PSC is 6540.

All interested companies shall provide quotations that are Brand Name or Equal To for the following:

Equipment Needed:

LKC Technologies

1 00857901006033 RETeval Complete (USA)

1 95-076 RETeval Flash Electrode & Supply Kit

4 95-068 Sensor Strip Electrodes (Box of 50 pairs)

1 Extended Warranty RETeval Complete Extended Warranty 1 year

Salient Characteristics: Electroretinogram

must be Portable, handheld - device can be used anywhere in various clinic settings

must have Constant pupil tracking - allows for non-dilated testing

must have Noninvasive Electrodes and not require corneal electrodes

Testing on both eyes can be completed in only few minutes

Appropriate for any age

Color-coded report to simplify interpretation

must have Diabetic retinopathy score

must have Automated dimming and reddening of the display during dark-adapted testing

must Dynamically measure and compensate for pupil size to create a consistent retinal stimulation

must Measure and report ambient light levels

Display must show real-time view

must have Objective test ability

used for management of diabetic, retinopathy, CRVO and glaucoma patients, at all stages

must include device training

must include report interpretation training

must be small enough to fit in a drawer or similar small area no larger than 14X8X5 inches

must have cordless ability with minimum 4 hour battery life

must be FDA approved for use with dilated and undilated pupils

must have minimum 1 year warranty

Should meet the Specifications of the RETeval Device

Light source

Red LED

(621 nm)

Green LED

(530 nm)

Blue LED

(470 nm)

White

RGB

Flash luminance energies(cd/m2)

0.0001-15

0.001-17

0.0001-5

0.002-30

Background Luminance (cd/m2)

0.03-3000

0.2-3500

0.03-1200

0.4-6000

Input type

Custom 3 pin connector with positive, negative, and right leg drive signal

Noise

100 dB at 50-60Hz

Frq. Range

DC-Couple

Flicker Frq.

Approximately 71nV /bit

Data resolution

Approx 71 nV / bit

Input range

+/- 0.6V

Sampling rate

Approx.. 2KHz

Timing accuracy

< +/- 0.1ms

Timing Precision

Typically, < +/-1 ms

Pupil Measurement

1.3mm 9.0mm -