6515-- Symplicity G3 Renal Denervation Generator Brand name or equal to

RDN Symplicity G3 Generator

2

STATEMENT OF WORK (SOW)

MEDICINE SERVICE/ CARDIOLOGY DIVISON

DEPARTMENT OF VETERANS AFFAIRS

CORPORAL MICHAEL J CRESCENZ VA MEDICAL CENTER

3900 WOODLAND AVE, PHILADELPHIA, PA 19104

GENERAL DESCRIPTION: The cardiology service of Michael J Crescenz, Medical Center 3900 Woodland Avenue, Philadelphia, PA 19104has a new brand name or equal to requirement for Symplicity G3 renal denervation RF generator which is used with sterile disposable catheters to treat Veterans with uncontrolled hypertension.

The renal denervation RF generator will provide additional treatment to Veterans with high blood pressure that are resistant to optimal medical therapy alone. Components include the Symplicity G3 generator and remote control. The generator features a real-time responsive algorithm that automatically adjusts power based on temperature and impedance feedback to ensure the safe distribution of energy delivered by the

SUPPLIES/SERVICES

The Corporal Michale J. Crescenz VA Medical Center Philadelphia requires a brand name or equal to purchase of the following equipment:

Item description of QTY/Unit/No. Supplies/Services

Item #

Description

Unit

QTY

MDTR RDNG3A

RDNG3A Symplicity G3 Generator

EA

1

DELIVERY

Corporal Michael J. Crescenz Veterans Affairs Medical Center Philadelphia

3900 Woodland Avenue

Philadelphia, PA 19104

45 Days from time of order. Anything other, please notify us.

SALIENT CHARACTERISTICS

The Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMC VAMC) Philadelphia requires that the RDN G3A Symplicity G3 Generator or equal, meet the following specifications:

Generator RDNG3A

Painted and nonpainted sheet metal

Polycarbonate/acrylonitrile butadiene styrene blend (external covers)

Thermoplastic elastomer (cord management strap)

Glass (projected capacitance touchscreen)

RF output power 6.5 W maximum per electrode (26 W total)

±20% accuracy with impedance of 175 to 200

±10% accuracy with impedance of 201 to 1200

Impedance measurement

175 to 250 , ±20%

251 to 700 , ±10%

701 to 1200 , ±15%

Fuse 2 Slow-Blow (T3.15A L, 250 V), 20 x 5 mm

Temperature range Measurement 37 °C to 65 °C, ±3 °C

Input power 100 to 240 V ~, 50/60 Hz universal power supply, 200 VA input power rating

Disconnecting the AC power cord removes AC mains power from the unit

AC power cables NEMA 5-15 3.0 m

Rated accessory voltage 150 Vp

Maximum output voltage 150 Vp

Maximum current rating 700 mA averaged over 60 s

STATEMENT OF WORK (SOW)

Project Scope

The Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMCVAMC) will be providing treatment to Veterans with high blood pressure that is resistant to optimal medical therapy alone. This request is for an MDT RGN GA-3 generator that is used with sterile disposable catheters to treat Veterans with uncontrolled hypertension. This request is for the capital portion of this service, the generator. The Symplicity G3 renal denervation RF generator, the only approved RF generator for renal denervation, is designed to deliver low-level radiofrequency (RF) energy, via the Symplicity Spyral multi-electrode renal denervation catheter, through the wall of the renal artery to achieve renal denervation. Components include the Symplicity G3 generator and remote control. The generator features a real-time responsive algorithm that automatically adjusts power based on temperature and impedance feedback to ensure the safe distribution of energy delivered by the catheter to the target site. The remote control provides a method for channel selection and RF activation from the sterile field.

Delivery Location

CMCVAMC Philadelphia

3900 Woodland Avenue

Philadelphia PA, 19104

Warranty and Support

Warranty of the equipment must be provided for a minimum of one year upon receipt, acceptance of equipment. The warranty must cover all manufacture defects and issues unrelated to typical use. Warranty and support should include a 4-hour call back response during normal business hours of 7:30AM- 4:30 PM Monday thru Friday (except holidays). Any service reports sent to all appropriate points of contact. The vendor shall provide all service reports with details of issues found to the clinical service as well as Biomedical Engineering.

Repairs or services that are performed during normal working hours should be covered by warranty/contract. A PM should be conducted on the probe prior to warranty expiration.

Installation

All work shall be coordinated with the department Nurse Manager, site Biomedical Engineering team and the Contracting Officer Representative (COR) and a phasing and work-schedule shall be provided. All work is to be executed as to not interfere or interfere as little as possible with normal functions of the Medical Center and department. The contractor is responsible for inspection of all parts, assembling the equipment, conducting an electrical safety check, and ensuring functionality of all features before the Medical Center will accept all equipment. The contractor shall keep work, storage, and staging areas clean and neat during this process.

Testing

The contractor shall verify to Biomedical Engineering and Interventional Cardiology Staff that the Generator meet all requirements through demonstration and validation. The contractor shall have no access to VA sensitive information during testing.

Manuals

The contractor will provide either hard copies or electronic copies of service manuals and instructions for use.

Work Hours

Normal business hours are 7:30 AM to 4:30 PM Monday thru Friday excluding Federal Holidays. Work completed outside this time must be requested through Facility Biomedical Engineering.

PERIOD OF PERFORMANCE Single procurement. No base or option period of performance.

MISCELLANEOUS INFORMATION: Payment Net 30 days.

POC INFORMATION: For any additional information contact Jill Neill, Nurse Manager Medicine- Cardiology, 215-823-5800 x203233 or Kaylee Updegrave, Biomedical Engineering 215-823-5800 x203387.