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

Active

Contract Opportunity

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.

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