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PRODUCT DESCRIPTION
For
NON-EXPENDABLE EQUIPMENT:
Recorders, Physiologic, pH, Upper Gastrointestinal Tract
Medtronic® Bravo™ Reflux Testing System Recorder
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 Recorders, Physiologic, pH, Upper Gastrointestinal Tract product line as a candidate for a VA-wide (otherwise referred to as “national”) contract for Recorders, Physiologic, pH, Upper Gastrointestinal Tract.
Electronic data storage recorders that include wireless transmitters, catheters (e.g., esophageal, biliary) and an electronic amplifier. There are two basic types of recorders: real time and retrospective, according to the point at which analysis is performed. These recorders are commonly used in ambulatory patients to correlate pH data (e.g., data related to gastroesophageal reflux) to patient symptoms.
The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Recorders, Physiologic, pH, Upper Gastrointestinal Tract to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months with four 12-month option periods.
2. REQUIREMENT
This requirement will be solicited and awarded as a sole source requirement which requires the quoter to provide the Medtronic® Bravo™ Reflux Testing System. 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.
| Contract Line Items |
| Manufacture |
| Part Number |
| Description |
| 0001 |
| Medtronic |
| FGS-0634 |
| Bravo CF Reflux Recorder |
| 0002 |
| Medtronic |
| FGS-0306 |
| Bravo Vacuum Pump (110V) Medela brand pump |
| 0003 |
| Medtronic |
| FGS-0309 |
| Bravo Vacuum Pump Kit Includes silicone tubing with coupling, 180 cm tubing (no fingertip control), 0.25 L canister, and lid with overflow protection |
| 0004 |
| Medtronic |
| ASM-0550-01 |
| Carry Case for BR2 Receiver Case only; straps sold separately USD 31.00 |
| 0005 |
| Medtronic |
| FGS-0340 |
| Bravo Vacuum Pump Tubes (10-pack) For Medela brand pump |
| 0006 |
| Medtronic |
| FGS-0493 |
| Calibration Stand – Bravo/Digitrapper Includes four 2793 tubes (250 mm x 18 mm) |
| 0007 |
| Medtronic |
| FGS-0687 |
| Bravo Pump Virus Filters (10-pack) |
| 0008 |
| Medtronic |
| FGS-0516 |
| Bravo pH Recorder Straps (5-pack) |
| 0009 |
| Medtronic |
| FGS-0656 |
| Reflux Software v6.1 Includes 10 licenses: for use with Bravo Calibration-Free (CF) |
| 0010 |
| Medtronic |
| PSP-0023-LF |
| 15W AC-DC Adaptor with Mini USB Plug |
| 0011 |
| Medtronic |
| PSP-0024-LF |
| Wall charger: plug adapter sold separately |
| 0012 |
| Medtronic |
| WIR-0075-LF |
| Interchangeable AC Plug Kit |
| 0013 |
| Medtronic |
| 80263 |
| Includes EU, UK, Australia, and US adapters |
| 0014 |
| Medtronic |
| 80264 |
| USB 1.1 Cable (A Male to B Mini, 1 m) USB cable only |
| 0015 |
| Medtronic |
| 80265 |
| Reflux Recorder – 1 Year Service Plan |
| 0016 |
| Medtronic |
| 80268 |
| Service Plan Reflux Recorder 1 Year, First Recorder |
| 0017 |
| Medtronic |
| 80269 |
| Reflux Recorder – 2 Year Service Plan Service Plan Reflux Recorder 2 Year, First Recorder (Bravo or Digitrapper) |
| 0018 |
| Medtronic |
| 80270 |
| Reflux Recorder – 3 Year Service Plan Service Plan Reflux Recorder 3 Year, First Recorder |
The Department of Veterans Affairs (VA) is seeking vendors who can provide Medtronic® Bravo™ Calibration-Free Wireless Esophageal pH Monitoring System Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.
CLIN’s 0001-0018 apply to the following SC’s:
| SC # |
| SALIENT CHARACTERISTICS |
| METHOD OF EVALUATION |
| SC – Literature Map |
| SC 1 |
| FDA Clearance – 510K required |
| Literature Review |
| Attached 510K approval letter from Vendor |
| SC 2 |
| Calibration-Free pH wireless Sensor Technology |
| Literature Review |
| User Manual Page 1 and Page 4 |
| SC 3 |
| Extended 96-Hour recording capability or better |
| Literature Review |
| User Manual Page 3 |
| SC 4 |
| Must be a wearable wireless external receiver capable of uninterrupted data collection |
| Literature Review |
| User Manual Page 9 |
| SC 5 |
| Receivers shall allow patients to record symptoms, meals, and body position changes |
| Literature Review |
| User Manual Page 9 |
| SC 6 |
| system shall include manufacturer-provided reflux analysis software specifically designed for use with the recorder |
| Literature Review |
| User Manual Page 41 |
| SC 7 |
| Must include Service Plans for the repair, maintenance and updating of system and software |
| Literature Review |
| Vendor’s website |
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