36C10G18Q0158-002.docx

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

Pacemakers: Cardiac External

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 Pacemakers: Cardiac External as a candidate for VA-wide (otherwise referred to as “national”) single award Requirements contract. Pacemakers: Cardiac External is designed to provide temporary pacing of the heart. The Pacemakers: Cardiac External generates impulses outside the body and delivers them to the heart through electrodes, either externally through the chest wall or invasively (e.g., through intravenous or transesophageal electrodes).

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Pacemakers: Cardiac External 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 each product that is being offered as an “equal” product to the Medtronic® brand of Pacemakers: Cardiac External. For each equal product, the quoter must include a description reflecting the characteristics 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 also must 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.

Pacemakers: Cardiac: External

The following SC apply to both dual chamber and single chamber External Pacemakers (CLIN 0001 and 0002)

SC1 The Pacemaker: Cardiac: External must be FDA approved and must comply with the International Electrotechnical Commission (IEC) 60601 standards.

SC2 The Pacemaker: Cardiac: External must have an easy to view screen and pacemaker indicators, including but not limited to, pacing rate, sensitivity, output values, pacing status, sensing status, pacing mode, delivery of a pacing pulse, indication of a sensed event, battery status, lock status and warnings.

SC3 The Pacemaker: Cardiac: External must have user controls that enable the user to adjust the pacemaker parameters, including but not limited to, pacing mode, rate, output, and sensitivity.

SC4 The Pacemaker: Cardiac: External must be battery powered with a minimum of 7 days of battery life at a rate setting of 80 pulses per minute (ppm) and other parameters set at nominal values.

SC5 The Pacemaker: Cardiac: External must provide a self-test function at start up.

SC6 The Pacemaker: Cardiac: External must provide a lock out feature to prevent unintended changes in pacemaker settings.

SC7 The Pacemaker: Cardiac: External must provide, at a minimum, electrostatic protection, defibrillation shock protection and pacing runaway protection.

The following SC applies to CLINs 0003 – 0018

SC8 The Pacemaker: Cardiac: External must provide compatible accessories, including but not limited to, IV pole hanger, covers, cases, cardiac pacing cables and lead wires. (CLINS 0003 through 0018)

The following salient characteristics apply to Pacemakers: Cardiac: External, “Dual Chamber” (CLIN 0001)

SC9 The Pacemaker: Cardiac: External (Dual Chamber) must provide, at a minimum, safe and effective battery powered short term (temporary) dual chamber external cardiac pacing indicated for therapeutic, prophylactic, or diagnostic purposes, including but not limited to heart blocks, bradycardia, atrial arrhythmias, ventricular arrhythmias, cardiac arrest, patient evaluation and support prior to implanting or replacing a permanent pacemaker and support during or after cardiac surgical procedures.

SC10 The Pacemaker: Cardiac: External (Dual Chamber) must provide both single and dual chamber pacing modes.

The following salient characteristics apply to Pacemakers: Cardiac: External, “Single Chamber” (CLIN 0002)

SC11 The Pacemaker: Cardiac: External (Single Chamber) must provide, at a minimum, safe and effective battery powered short term (temporary) single chamber external cardiac pacing indicated for therapeutic, prophylactic, or diagnostic purposes, including but not limited to heart blocks, bradycardia, atrial arrhythmias, ventricular arrhythmias, cardiac arrest, patient evaluation and support prior to implanting or replacing a permanent pacemaker and support during or after cardiac surgical procedures.

SC12 The Pacemaker: Cardiac: External (Single Chamber) must provide single chamber pacing modes.

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