ATTACHMENT B - PRODUCT DESCRIPTION - NX EQ Heart Lung Bypass Units.pdf

PRODUCT DESCRIPTION

For

NON-EXPENDABLE EQUIPMENT:

LivaNova® Essenz Perfusion System (Heart-Lung Bypass Units) or Equal

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 Heart-Lung Bypass Units product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

The LivaNova® Essenz Perfusion System (Heart-Lung Bypass Units) or equal are designed to provide temporary external circulatory support to the cardio-pulmonary functions by oxygenating the body's venous supply of blood and pumping it back into the arterial system; bypass units perform circulation oxygenation and filtration of the blood. These units are usually assembled in a console, are modular, and contain main components consisting of an arterial pump, a backup arterial pump, one or two suction pumps, an arterial vent pump, a cardioplegia pump, and a backup unit along with some disposable components such as an oxygenator/heat exchanger, a cardiotomy reservoir, blood filters, and tubing. Heart-Lung Bypass Units are mostly used during open heart surgery, bypassing the heart to facilitate surgery on the organ (e.g., cardiac valve replacement, coronary artery bypass grafting) and are also used for extracorporeal membrane oxygenation in patients with severe respiratory disorders.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide Heart-Lung Bypass Units to be used by clinicians throughout the VA medical centers and facilities located in the Continental United States (CONUS) or Outside of the Continental United states (OCONUS). The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the Offeror to indicate that each product being offered as an “equal” product to the LivaNova® Essenz Perfusion System (Heart-Lung Bypass Units). For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The Offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the Offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

Contract Line

Items Brand Part Number Description

0001 LivaNova Base Unit

LivaNova Base Unit (Essenz Perfusion System / Heart-Lung Bypass Unit) 4 Pump Console (includes: Timer, power supply, emergency power supply, electronic and power supply pack, mast system, hand crank, hand crack bracket, poles, uninterruptable power supply/battery back-up, and vacuum regulator), Focus Data Yr1 (MPN 80700046), and Data Connectivity Installation

0002 LivaNova CP Long Centrifugal Pump Long 0003 LivaNova CP Short Centrifugal Pump Short 0004 LivaNova 49-00-10 Console 0005 LivaNova EGB10L Electronic Gas Blender - 10L 0006 LivaNova EGB2L Electronic Gas Blender - 2L 0007 LivaNova EGB5L Electronic Gas Blender - 5L 0008 LivaNova CP Kin Assist Centrifugal Pump Kinetic Assist 0009 LivaNova 60-04-50 Centrifugal Pump Drive 0010 LivaNova ILBM - VA In-Line Blood Monitor Complete

0011 LivaNova RP150 Large Large Roller Pump, Large Roller Pump Support, and Large Roller Tube Part Short

0012 LivaNova 10-90-00 Large Roller Pump Only

0013 LivaNova RP85 Small Small Roller Pump, Small Roller Pump Support, and Small Roller Tube Part Short

0014 LivaNova VC Ven Clamp Venous Clamp 0015 LivaNova 96-415-140 Perfusion System Monitor 0016 LivaNova 12-80-40 Electronic Venous Clamp 0017 LivaNova 10-95-00 Small Roller Pump Only 0018 LivaNova ILBM - V In-Line Blood Monitor Venous 0019 LivaNova 96-414-180 Arterial Sensor & Reference Element 0020 LivaNova 60-05-35 Arterial Clamp - Long Arm 0021 LivaNova 60-05-30 Arterial Clamp - Short Arm 0022 LivaNova 49-10-01 Cabinet Assembly Right 0023 LivaNova 49-10-99 Cabinet Assembly Left 0024 LivaNova 96-414-170 Venous Sensor & Reference Element 0025 LivaNova 28-97-10 Cockpit 0026 LivaNova 25-95-10 B-Capta Module Adapter 0027 LivaNova 96-490-042 Mechanical Gas Blender, O2 & Air 0028 LivaNova 12-40-00 Mechanical Venous Line Clamp

0029 LivaNova Control Unit Control Unit (Includes 28-96-00 (Control Unit) and 97-102-244 (System Cable))

0030 LivaNova Level Level 0031 LivaNova 23-65-10 Bubble Module 0032 LivaNova 28-96-00 Control Unit Only, No Cable

0033 LivaNova 19-03-00 Bracket for Gas Bottles 0034 LivaNova 23-41-10 Level Module 0035 LivaNova 49-10-30 Main Interface Box 0036 LivaNova 96-490-131 Air Tubing Set for Mechanical Gas Blender 0037 LivaNova 96-490-132 O2 Tubing Set for Mechanical Gas Blender 0038 LivaNova 96-414-220 Flow Sensor 3/16" 0039 LivaNova 96-414-230 Flow Sensor 1/4" 0040 LivaNova 96-414-240 Flow Sensor 3/8" 0041 LivaNova 96-414-250 Flow Sensor 1/2" 0042 LivaNova 49-05-65 Cable Box 0043 LivaNova 60-04-55 Centrifugal Pump Emergency Drive 0044 LivaNova 22-20-10 Pressure Module 0045 LivaNova 49-05-11 Support Plate 0046 LivaNova 28-96-60 Control Unit Arm 0047 LivaNova 96-414-320 Bubble Sensor 3/16" 0048 LivaNova 96-414-330 Bubble Sensor 1/4" 0049 LivaNova 96-414-340 Bubble Sensor 3/8" 0050 LivaNova 96-414-350 Bubble Sensor 1/2" 0051 LivaNova 25-60-10 Flow Module 0052 LivaNova 050350000 PAS SECHRIST 3500 CP-G Adapter 0053 LivaNova 50-70-57 C-Shaped Mast

0054 LivaNova 80700046

FOCUS Data Fee - Annual - Essenz Perfusion System focus data annual software license and subscription. Required annual renewal to maintain active updates and software functionality. Included in first year purchase of Base Unit.

0055 LivaNova 20-30-10 Temperature Module 0056 LivaNova 49-05-29 Extension Arm 0057 LivaNova 49-05-24 Arterial Extension Arm 0058 LivaNova 12-30-90 Mechanical Venous Clamp Holder 0059 LivaNova 41-02-98 Perfusion Chair 0060 LivaNova 49-10-61 Shelf 0061 LivaNova 28-96-50 Control Unit Double Holder 0062 LivaNova 45-04-03 Medex Transducer 0063 LivaNova 73-200-520 Cockpit Arm 0064 LivaNova 10-95-80 Twin Holder

0065 LivaNova 96-403-072 Power Plug 230V 0066 LivaNova 23-41-50 Level Sensor 0067 LivaNova 49-05-20 Table Set Mast 0068 LivaNova 35-05-85 Lamp 0069 LivaNova 25-95-70 Venous Sensor Holder 0070 LivaNova 25-95-80 Arterial Sensor Holder 0071 LivaNova 96-490-111 Air Tubing Set for Electronic Gas Blender 0072 LivaNova 96-490-112 O2 Tubing Set for Electronic Gas Blender 0073 LivaNova 96-490-113 CO2 Tubing Set for Electronic Gas Blender 0074 LivaNova 96-403-073 Power Plug 120V 0075 LivaNova 97-102-244 Control Unit System Cable 0076 LivaNova 0395-2049 SPD Truwave Xducer Cable 0077 LivaNova 24-10-10 Mast Holder with Fast Clamp Connector 0078 LivaNova 45-12-74 Dräger Infinity, SC9000 Adapter

0079 LivaNova 25-30-50 Accessories Kit for plugging into Mechanical Blender

0080 LivaNova 23-41-51 Level Pads - 100 pcs 0081 LivaNova 45-12-64 Marquette Monitor 5m Adapter 0082 LivaNova Long Support Long Support 0083 LivaNova 042229000 Inspire Oxygenator Temp Probe 0084 LivaNova 45-10-50 Equalization Cable 0085 LivaNova Short Support Short Support

0086 LivaNova 24-30-15 Mast Holder for Power Adapter with Fast Clamp Connector

0087 LivaNova 10-61-92 Variolock Tubing Clamp Insert 2:1

0088 LivaNova 10-61-94 Variolock Tubing Clamp Insert 4:1 (USA only)

0089 LivaNova 48-30-75 INFUSION RACK CPL Essenz 0090 LivaNova 10-61-72 Insert Varilock, BLUE 0091 LivaNova 10-61-73 Insert Varilock, RED 0092 LivaNova 10-61-91 Variolock Tubing Clamp Insert 1:1 0093 LivaNova 49-05-35 Tray - Right Side 0094 LivaNova 49-05-39 Tray - Left Side 0095 LivaNova 49-05-41 Pump Support 0096 LivaNova 050350100 SECHRIST IV308 Hose Air 14 FT Adapter 0097 LivaNova 050350200 SECHRIST IV309 Hose Oxy 14 FT Adapter 0098 LivaNova 45-09-10 Cable Holding and Organizing System

0099 LivaNova 49-05-80 Pump Support Caps (6 pieces) 0100 LivaNova 28-96-40 Control Unit Holder 0101 LivaNova 43-42-61 Cap for Fast Clamp (6 pcs.)

0102 LivaNova 000-11-0001 Connection Cable Data Pad II 0103 LivaNova 97-102-239 Heater Cooler Cable 0104 LivaNova 97-102-250 Electronic Gas Blender Cable 0105 LivaNova 49-05-44 Centrifugal Tube Part - Long 0106 LivaNova 45-12-46 Extension Cable 3m 0107 LivaNova 45-12-47 Extension Cable 5m 0108 LivaNova 45-12-57 Medtronic Biotrend 3m Adapter 0109 LivaNova 45-12-58 Xtra 3m Adapter 0110 LivaNova 45-12-61 CDI500, CDI550 3m Adapter 0111 LivaNova 45-12-62 Datamaster Adapter 0112 LivaNova 45-12-63 Cobe Sat/Crit 3m Adapter 0113 LivaNova 45-12-65 HP Merlin 3m Adapter 0114 LivaNova 45-12-66 Datex AS/3 3m Adapter 0115 LivaNova 45-12-67 Hemochron Signature 3m Adapter 0116 LivaNova 45-12-68 Medtronic ACT II 3m Adapter 0117 LivaNova 45-12-69 Philips InterlliVue 3m Adapter 0118 LivaNova 45-12-70 Somanetics Invos 5100 3m Adapter 0119 LivaNova 45-12-72 Marquette 8000M, Vamos 3m Adapter 0120 LivaNova 97-102-268 HC AUX Can Adaptor Cable 0121 LivaNova 97-102-306 Adaptor Power Cable US 0122 LivaNova Clips + Roofs Clips and Roofs 0123 LivaNova 49-05-42 Centrifugal Tube Part - Short 0124 LivaNova 49-05-42 Large Roller Tube Part - Short 0125 LivaNova 49-05-42 Small Roller Tube Part - Short

0126 LivaNova 10-07-21 Mechanical Venous Clamp Insert 1/4" x 3/32"

0127 LivaNova 10-07-22 Mechanical Venous Clamp Insert 3/8" x 1/16"

0128 LivaNova 10-07-24 Mechanical Venous Clamp Insert 1/2" x 1/16"

0129 LivaNova 10-07-26 Mechanical Venous Clamp Insert 5/8" x 3/32"

0130 LivaNova 10-07-27 Mechanical Venous Clamp Insert 1/8" x 1/16"

0131 LivaNova 10-07-28 Mechanical Venous Clamp Insert 3/16" x 1/16"

0132 LivaNova 97-102-309 Elongation Power Cable 0133 LivaNova 45-12-03 Connection Cable, Essenz, Patient Monitor 0134 LivaNova 28-96-80 Color Knob Rings & Stickers 0135 LivaNova 050111090 PAS Water FTG RT ANG 0136 LivaNova 45-12-08 Connection Cable, Essenz, Special Convert 0137 LivaNova 49-05-70 Cable Clips (6 pieces) 0138 LivaNova 49-05-22 Hook for Clamps 0139 LivaNova 97-102-227 Power Cord HLM (USA/Canada) 0140 LivaNova 97-102-307 Power Cord Perfusion System Monitor 0141 LivaNova 97-102-302 Power Cord EPM (2m, USA/Canada) 0142 LivaNova 97-102-303 Power Cord EPM (6m, USA/Canada) 0143 LivaNova 49-05-71 Cable Clip Roof (3 pieces) 0144 LivaNova 10-96-10 Tubing Clamp Block 1/8" x 1/16" 0145 LivaNova 10-96-11 Tubing Clamp Block 3/16" x 1/16" 0146 LivaNova 10-96-12 Tubing Clamp Block 1/4" x 1/16" 0147 LivaNova 10-96-13 Tubing Clamp Block 1/4" x 3/32" 0148 LivaNova 10-96-14 Tubing Clamp Block 5/16" x 1/16" 0149 LivaNova 10-96-15 Tubing Clamp Block 5/16" x 3/32" 0150 LivaNova 050114000 Hansen Male-Male Water Fitting Adapter 0151 LivaNova 28-95-34 Power Pack Blind Cover 0152 LivaNova 76-102-997 Color Coding Stickers 0153 LivaNova 75-521-603 Level Sensor Holder 0154 LivaNova 76-102-996 Cable Flags, WHITE

The Department of Veterans Affairs (VA) is seeking vendors who can provide LivaNova® Heart-Lung Bypass Units or equal as listed above which meet all the salient characteristics listed below. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. 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.

SCs 1 through 8 apply to CLIN 0001:

SC # SALIENT CHARACTERISTICS METHOD OF

EVALUATION

SC 1

Heart-Lung Bypass Units must be designed for cardiopulmonary bypass and/or extracorporeal circulation procedures

Literature Review

SC 2 Heart-Lung Bypass Units must include an uninterruptable power supply (UPS) or back-up battery Literature Review

SC 3 Heart-Lung Bypass Units must have a user interface Literature Review

SC 4 Heart-Lung Bypass Units must be modular; allowing various and additional configurations Literature Review

SC 5 Heart-Lung Bypass Units must monitor and display parameters Literature Review

SC 6 Heart-Lung Bypass Units must provide alarms and warnings Literature Review

SC 7 FDA Approval Literature Review

SC 8

Manufacturer Warranties - should outline any length and coverage of warranties/guarantees associated with their products, as these can provide assurance of quality and reliability to the government.

Literature Review