SON Medtronic M5 Microdebrider---646 (002).docx

VA Pittsburgh Healthcare System (VAPHS)

STATEMENT OF NEED AND GENERAL SPECIFICATIONS

FOR

Medtronic M5 Microdebrider Kit

1. Background The VA Pittsburgh Healthcare System currently has a New Brand Name requirement for four (4) Medtronic M5 Microdebrider w/Instr Tray Bundle to be used in the ENT Department and the OR.

2. Scope of Work The IP System is a powered microdebrider, drill and saw system that will remove soft tissue, hard tissue, and bone during surgical procedures. The system consists of a power control console, foot pedal, connection cables and assorted handpieces to drive various burs, blades, drills, rasps, cannula, and saws. It includes integrated irrigation pumps for irrigation of blades, burs and for motor coolant.

In addition to the handpieces and pumps there is a connection for continuous stimulation of the Visa straight burs that enables nerve integrity monitoring during surgical procedures. The Nerve Integrity Monitor (NIM) is a separate device that stimulates and monitors the nerve. This system has connections that allow the NIM to relate to the Visao handpiece and stimulating bur guard, enabling the NIM to stimulate and monitor the nerve at the surgical site.

3. General Requirement: Medtronic M5 Microdebrider w/Instr Tray Bundle (Brand Name Only)

4. Additional Information A Microdebrider that can reach speeds up to 30K with only one gear. We need a system that will operate smooth and give ZERO push back to our surgeons as they navigate some of the most delicate regions of the body. This system should also be able to accept as well as provide many attachments that can be easily changed out at a moment’s notice. We also need a straight suction system that will eliminate the need for external suctions pumps which tend to clog.

5. Delivery Location Delivery should be coordinated with the POC of the contract prior to shipping of any equipment.

POC:

Scott Deluisio, Scott.Deluisio@va.gov, 412-360-3508.

Delivery Location:

VA Pittsburgh Healthcare System University Drive C, Room 2A118 Attn: Scott Deluisio / Emily Moore Pittsburgh PA 15240 412-360-3508 Scott.deluisio@va.gov

The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government.

Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with POC once a ship date is established. The POC, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the POC. Failure the coordinate shipment with POC, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number