36C10G18Q0094-002.pdf

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

RADIOFREQUENCY GENERATOR

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) Non-Expendable Equipment National Program has identified the Radiofrequency Generator product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

Radiofrequency Generators are used for surgical cutting or to control bleeding by causing coagulation (hemostasis) at the surgical site. They deliver high-frequency electrical currents and voltages through an active electrode, causing desiccation, vaporization, or charring of the target tissue. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Radiofrequency Generators to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one (1) 12 month base period with two

(2) twelve (12) month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires that the quoter indicate that each product that is being offered as an “equal” product to the Medtronic® brand of Radiofrequency Generators. For each equal product, the offeror 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 quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract Line Items

Item Description Part Number

0001 AEX™ Generator AEX™Generator provides radio frequency (RF) energy to disposable Monopolar and Bipolar electrosurgical hand pieces.

The AEX™ Generator accepts a Patient Return Electrode for monopolar applications, and includes a rotary peristaltic pump for simultaneous delivery of saline for a hemostatic sealing.

40-405-1

The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® brand of Radiofrequency Generators as listed above or equal commodities that meet all of the following salient characteristics:

SC # SALIENT CHARACTERISIT METHOD OF

EVALUATION

SC 1 Must Operate in Cut Mode, Coagulation Mode and Hemostatic Sealing Mode Literature Review

SC 2 Capable of supporting multiple Aquamantys Bipolar Literature Review

Sealers that range in size from 2.3mm to 6.0mm

SC 3 Epidural Vein Sealer need to have a mini epidural vein sealer Literature Review

SC 4 Have an Endo DBS 8.7 Bipolar sealer Literature Review SC 5 Be able to adapt to a 9.5 XL Bipolar sealer Literature Review

SC 6 Must have multiple power settings in each mode Literature Review

SC 7 Device must have had controls as well as footswitch control (infrared wireless footswitch) Literature Review

SC 8

Device must have a minimum of 4 preset memory buttons to retain and recall user preferences (default set points and volume level)

Literature Review

SC 9 Device must connect to Patient return Electrode and impedance sensing feature Literature Review

SC 10

Device must have Color LCD with touch screen feature to prompt user for input and to display informational, error, and fault messages

Literature Review

SC 11 Device must have audio feedback—activation and alarm tones Literature Review

SC 12 Device must have Monopolar and Bipolar connectors Literature Review

SC 13 Alarm Tones must meet the requirements for IEC 60601- 2-2 Literature Review

SC 14 Must conform to electromagnetic compatibility standard EN/IEC 60601-1-2 Literature Review

SC 15 Generator and Wireless Footswitch must be warranted for a minimum of 1 year, parts and labor. Literature Review