36C10G20Q0002-002.docx

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NX EQ Tympanometers (VA-19-00093479)
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36C10G20Q0002
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36C10G20Q0002 ATTACHMENT B _ MINIMUM SALIENT CHARACTERISTICS_PRODUCT DESCRIPTION.docx

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PRODUCT DECRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Welch Allyn MicroTymp 4 Portable Tympanometer and TM 286 AutoTymp Tympanometric System: Middle Ear Analyzers

Prepared By:

Strategic Acquisition Center Department of Veterans Affairs 10300 Spotsylvania Avenue, Suite 400 Fredericksburg, VA 22408

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified the Welch Allyn MicroTymp 4 Portable Tympanometer and the TM 286 AutoTymp Tympanometric System, Brand Name or Equal Middle Ear Analyzers as candidates for a VA-wide (otherwise referred to as “national”) single award Requirements contract.

The Welch AllynMicroTymp 4 Portable Tympanometer Middle Ear Analyzer is a hand-held probe that is placed in the ear to measure energy transmission through the middle ear. It can be used to test the condition of the middle ear, determining whether it is functioning normally, contains fluid, or whether the tympanic membrane has been punctured.

The Welch Allyn TM 286 AutoTymp Tympanometric System is an audiometric screening product that offers basic pure tone audiometry, an tympanometry reflex. The TM286 Auto Tymp is available with both 226Hz and 1Khz probe tones to accommodate testing for patients between the ages of birth through geriatric. An acoustic reflex occurs when a very loud sound (stimulus) is presented to the auditory pathway. During acoustic reflex testing, the stimulus is presented to the ear canal through a probe (ipsilateral-Micro Tymp 4 Portable). This stimulus then travels through the middle ear to the cochlea. From the cochlea, frequency and intensity information is transmitted via the 8th nerve to the brain stem where a determination is made as to whether the intensity of the stimulus is high enough to elicit a reflex response.

The Vendor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Middle Ear Analyzers to be used by clinicians throughout the VA medical centers and facilities. The period of performance will be for one 12-month base period with two 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the vendor indicate that each product being offered is an “equal” product to the Welch Allyn Middle Ear Analyzers listed below in Table A.

For each equal product, the vendor must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The vendor must also clearly identify the item by brand name (if any) and make/model number. Finally, the vendor must include descriptive literature, such as illustrations or drawings and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

TABLE A

CLIN
Manufacture
Part Number
Description
0001
Welch Allyn
93700
MicroTymp 4 Portable Tympanometer System

Complete System Includes:

Part Number 93700, MicroTymp 4 Portable Part Number 93710, MT4 Charging Cradle Part Number 93715, MT4 Power Supply Part Number 93720, MT4 Ear Tip Starter Set† Part Number 93730, MT4 Probe Tip Cleaning Kit Part Number 93750, MT4 Four-Volume Test Cavity Part Number 39414, MT4/OAE USB Data Cable Part Number 93771, MT4 Printer Cable Part Number 39410, MPT-II Thermal Printer Kit

0002
Welch Allyn
28600
TM 286 AutoTymp Tympanometric System

Complete System Includes:

Part Number 28600, TM 286 AutoTymp Part Number 26100, TM Eartips (6 sizes, 2 each) Part Number 26241, TM Test Cavity Part Number 28203, DD45 Audiometry Headset External Part Number 28206, Threshold Audiometry Card Part Number 28600, TM286 Probe Assembly Part Number 28601, TM286 Power brick (for devices with serial numbers GS0077116 and earlier) Part Number 729243, Power supply AM282, TM 286, 4th Edition (for devices with serial numbers GS0077117 and later) Part Number 28603, TM286 Directions for Use Manual (printed, English only) Part Number 28604, TM286 Quick Reference Guide Part Number 28607, TM Wall Chart for Tymp tracings Part Number 52600, Thermal Paper 4" wide (3 rolls shipped with system)

The Department of Veterans Affairs (VA) is seeking vendors who can provide the Welch Allyn MicroTymp 4 Portable Tympanometer and the TM 286 AutoTymp Tympanometric System as listed above or Brand Name or Equal Middle Ear Analyzers which meet all the following salient characteristics:

CLIN 0001 MicroTymp 4 Portable Tympanometer System Part Number 93700

SC #
SALIENT CHARACTERISTICS
METHOD OF EVALUATION
LOCATION IN LITERATURE
SC 1
Must have Probe Tone frequency, intensity range 226 Hz ± 2%, 85 dB SPL in 2 cm³
Literature Review
SC 2
Must have a Pressure Range of +200daPa to -400daPa +/-10daPa10
Literature Review
SC 3
Must provide a Volume Range & Accuracy of 0.2ml to 5ml +/- 0.1ml
Literature Review
SC4
Must be capable of Acoustic Reflex test method of Ipsilateral or Contralateral
Literature Review
SC 5
Must provide Reflexes frequencies of 500Hz, 1kHz, 2kHz, 4kHz +/- 3%
Literature Review
SC 6
Battery capacity minimum 100-240Vac; 50/60Hz; or rechargeable battery
Literature Review
SC 7
Must be able to Display measurement results
Literature Review
SC 8
Must meet Safety Standards IEC 60601-1
Literature Review

CLIN 0002 TM 286 AutoTymp Tympanometric System Part Number 28600

SC #
SALIENT CHARACTERISTICS
METHOD OF EVALUATION
LOCATION IN LITERATURE
SC 1
Must have Probe Tone frequency, intensity range 226 Hz ± 2%, 85 dB SPL in 2 cm³
Literature Review
SC 2
Must have a Pressure Range of +200daPa to -400daPa +/-10daPa10
Literature Review
SC4
Must be capable of Acoustic Reflex test method of Ipsilateral or Contralateral
Literature Review
SC7
Must be able to Display measurement results
Literature Review
SC8
Must meet Safety Standards IEC 60601-1
Literature Review

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