Technical Specifications.pdf

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Attached to
6515-- Bundle M5 Microdebrider w/Instra Tray Federal contract opportunity
Solicitation number
36C25924Q0119
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19

About this file

This technical specification document outlines requirements for a Medtronic Integrated Power Console system and associated handpieces and accessories for ENT surgeries at the Rocky Mountain Regional VA Medical Center. The system includes an integrated power console, foot pedal, connection cables and assorted handpieces. Delivery is required within 14 days of award to the specified VA location, with operation between 0700-1500 hours Monday through Friday, excluding federal holidays. The contractor must provide two each of operation and maintenance manuals in binders and digital format delivered to the points of contact. Security background checks and system access are not required as the contractor will not handle protected health information or remove equipment from the VA.

The related federal contract opportunity is a solicitation from the Department of Veterans Affairs for bundle M5 Microdebrider kits with instrument trays to be provided under solicitation number 36C25924Q0119. Pricing and response dates are not specified in the documentation provided.

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Technical Specifications Eastern Colorado HealthCare System

Rocky Mountain Regional VA Medical Center

1. Purpose:

1.1 The Department of Veterans Affairs, Eastern Colorado HealthCare System, Rocky Mountain Regional Hospital is requesting a Firm-Fixed Contract for the delivery of a Medtronic Integrated Power Console and the M5 Straight shot microdebrider hand piece. This system is a multispecialty surgical power console for removing soft tissue, hard tissue, and bone during ENT surgeries. It will be used for sinus and turbinate surgeries.

2. Salient Characteristics:

2.1 The Integrated Power Console 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, cannulae and saws. It includes integrated irrigation pumps for irrigation of blades, burs and for motor coolant.

2.2 Essential/significant physical, functional, or performance characteristics.

Integrated Power Console:

Physical Dimensions

Size: 277 mm Width x 353 mm Height x 267 mm Depth

Weight: 7.3 kg

Operational Environment Temperature: +10 °C to +33 °C

Humidity: 30 % to 75 % RH

Barometric Pressure: 700 - 1060 hPa

Transport and Storage Environment Temperature: -40 °C to +70 °C

Humidity: 10 % to 95 % RH

Barometric Pressure: 500 to 1060 hPa

Display / Touchscreen: High contrast, digital, graphic color, visible in complete darkness

Resolution. Display 21 cm diagonal, resolution 480 X 640 pixels

Audio Output Baseline Audio Sound Level: 60 dBA minimum SPL (1 m)

Electrical Input Voltage: 100 V-240 V ± 10%

Frequency: 50/60 Hz

Power Consumption: 500 VA

Auxiliary AC output: 200 VA Max.

Internal Fuse:5 x 20 mm T. L. 5 A, 250 V

Medtronic Xomed P/N 11270066

Duty Cycle for Applied Part: Maximum On Time 120 Seconds. Minimum Off Time 180 Seconds

Disposable supplies for the equipment shall be readily available

StraightShot M5:

Size 12.5 cm Length x 2.0 cm Width (1899200)

Weight 203 g 1899200

Speed 50-7500 rpm oscillate.

50-30000 rpm forward

Duty Cycle for Applied Part: The StraightShot™ M5 handpiece under full load is rated for intermittent operation per the following: Maximum On Time: 60 seconds. Minimum Off Time: 30 seconds

2.3 The purchase shall include manufacturer’s warranty.

2.4 Nomenclature and Part Number(s):

CLIN Part Number Nomenclature Unit of Measure Quantity 0001 IPCES2SYSKIT Bundle IPC SYS and

Endoscrub 2 Access

EA 1

0002 1898001 Console 1898001 IPC EA 1 0003 1898430 Foot Switch 1898430 ROHS EA 1 0004 1897821 Power Cord 1897821 6 Meter

IEC320 115V

EA 1

0005 1898851 Manual 1898851 Integrated Pwr Console EN

EA 1

0006 1897510 Basket 1897510 XPS IV Pole Storage

EA 1

0007 1852000 Footswitch 1852000 Endo- Scrub 2

EA 1

0008 1991015 Finger Switch 1991015 Endo- Scrub 2 ROHS

EA 1

0009 M5KIT1 Bundle M5 Microdebrider w/Instra Tray

EA 3

0010 1899200 Microdebrider 1899200 M5

ROHS

EA 1

0011 1899076 Instrument Tray 1899076 M5 EA 1

3. Delivery:

3.1 Delivery will be made within 14 days of award unless specified differently within the scope of the contract.

3.2 Delivery Location:

Rocky Mountain Regional VA Medical Center (Station 554)

1700 North Wheeling Street

Aurora, CO 80045-7211

3.3 Delivery Hours of Operation: Monday – Friday; 0700hrs – 1500hrs; excluding all Federal Holidays and any other day specifically declared a National Holiday by the President of the United States.

New Year’s Day Dr. Martin Luther King Jr’s Birthday Presidents’ Day Memorial Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

3.4 When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by US Government Agencies.

3.5 Delivery Markings: Contractor shall deliver items in manufacturer's original sealed containers with manufacturer’s name marked thereon. Deliveries shall be marked with the following information:

• Purchase Order Number

• Contract Number

• Mark For Attention: Danielle Winslow

3.6 Delivery POCs: Danielle Winslow, 720-642-0099, Danielle.winslow@va.gov

Richard Moya, (720) 723-6622, Richard.moya@va.gov

3.7. Operation and Maintenance Deliverables:

3.7.1 Operation and Maintenance Manuals:

3.7.1.1 Binders; Quantity of 2 each for items listed in Paragraph 2, Section 2.

3.7.1.2 Digital Copies; Quantity of 2 each for items listed in Paragraph 2, Section 2.

3.7.1.3 Deliver compilation of all manufacturers recommended maintenance schedule and operation materials packaged in binder (s) to the POC listed in the Paragraph 3, Section 4.

4 Security Requirements:

4.1 Security background checks are not required.

mailto:Danielle.winslow@va.gov mailto:Richard.moya@va.gov

4.2 The Contractor will not have access to VA Desktop computers they will not have access to online resources belonging to the government.

4.3 The Contractor will not have access to protected Patient Health Information (PHI), nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required; any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

4.4 The C&A Requirements do not apply.

4.5 The Security Accreditation Package is not required.

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