6515--NX EQ Cardiopulmonary Diagnostic Systems

Page 11 of 11

Solicitation Number: 36C10G24R0018

Notice Type: Combined Synopsis/Solicitation

Synopsis: COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation number 36C10G24R0018 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular 2024-06, dated 29August 2024.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Cardiopulmonary Diagnostic Systems product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award.

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Vyaire® Cardiopulmonary Diagnostic Systems. 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 quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter 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.

A Brand Name or Equal (BNOE) single award Requirements contract will be awarded IAW FAR 13.303 by all terms, conditions, provisions, specifications, and schedule of this solicitation herein.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 Surgical Appliance and Supplies Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies, and the associated size standard is 800 employees. This procurement action is issued as full and open competition.

All interested companies shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEM.

The proposed acquisition is for a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract.

The type of Cardiopulmonary Diagnostic Systems required for this program has been identified as most advantageous to the Government to be incorporated into a national Requirements Contract. The salient characteristics (SC) for these commercial items are identified in the NX EQ Cardiopulmonary Function Diagnostic Systems Product Description.

The period of performance is for a base of 12 months with four 12-month option periods. Delivery is FOB destination. Firm-fixed price Orders will be placed against this Requirements contract in writing and will provide the delivery locations, delivery dates, and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including the attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also apply to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. The addendum is attached.

Clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause apply to the acquisition. The addendum is attached.

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting a proposal. You may access SAM at https://sam.gov/SAM/. Proposals shall contain the terms for cost/price and technical capabilities of the equipment. The Government reserves the right to award without discussions. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on October 29, 2024, to Contract Specialist, Lisa Thompson at Lisa.Thompson10@va.gov and Contracting Officer, Sharon Redman at Sharon.Redman@va.gov. No calls will be accepted.

Proposals are due via email by 11:59 PM EST on November 6, 2024, to Contract Specialist, Lisa Thompson at Lisa.Thompson10@va.gov and Contracting Officer, Sharon Redman at Sharon.Redman@va.gov.

1. SCOPE OF WORK

The Cardiopulmonary Diagnostic Systems are a diagnostic modality used to evaluate a patient's functional capacity. Cardiopulmonary Diagnostic Systems can identify cardiac or pulmonary disease in patients with marginally abnormal diagnostics or in those who appear more clinically disabled than their diagnostic tests indicate. Collected data allows the clinician to assess a patient s overall cardiopulmonary function. This can be useful in pre-operative risk assessment, the diagnosis of various cardiopulmonary diseases, the evaluation of post-operative recovery, or more general assessment of an individual s exercise capacity. The test can provide a wealth of knowledge about both cardiac and pulmonary disease processes, while also aiding in the development of individualized therapy and rehabilitation programs.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Cardiopulmonary Diagnostic Systems to be used by clinicians throughout the VA medical centers and facilities. 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 quoter to indicate that each product being offered is an equal product to the Vyaire Cardiopulmonary Diagnostic Systems. 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 quoter 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 Item#

Brand

Part Number

Description

0001

Vyaire

31797-001

VYNTUS BODY PC Diffusion System. Includes 1110L body

plethysmograph with 551-pound patient bench and 25 inches

telescoping arm, breathing circuit (including Ultrasonic sensor,

Flow Path Valve, and Demand Valve), SentrySuite software,

validated WIN 10 PC with sanitizable medical keyboard/mouse,

27-inch flat panel monitor, Office Jet printer, 3-L manual syringe,

DLCO pressure regulator, 6-cylinder gas stand, box of 80

MicroGard IIB filters. Tests performed: Spirometry (FVC, SVC,

MVV), Lung subdivisions (VTG, FRCpl, RV, TLC, Raw,

Conductance and specific resistance and Resistance Volume

Loops), Real-time DLCO (both Single Breath and Intrabreath,

MIP/MEP, and pre/post bronchodilator. Standard software

includes: Guidance and Stabilitrac instructional applications, preformatted reports, and reference sets with design tools for

modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1st year warranty included. Vyntus Standard Cart (V-859140-13) is not included.

0002

Vyaire

V-859140-13

VYNTUS STANDARD CART with 2 shelves, top half cart is

adjustable up/down height, left/right mousepad, monitor mount,

mounting mechanism for arm, isolation transformer, and cable management spine.

0003

Vyaire

001-375420

ITGV SIMULATOR - Body Box quality control device

0004

Vyaire

760707

POWER CORD HOSPITAL GRADE - required for ITGV 001-375420

0005

Vyaire

32925-001

Additional Breathing Circuit for Vyntus BODY. Includes: 1 each of USS Module with polytube adapter, Flow Path Valve, Shutter and 1 pk of 5 Silicone Valves.

0006

Vyaire

31776-001

VYNTUS ONE PC System for PFT and CPET testing. Includes analyzer module (O2, CO2, Multigas), breathing circuit (including Ultrasonic sensor, Flow Path Valve, Demand Valve, and DVT sensor, 2 bxb sample lines), built-in pulse oximeter (finger,

forehead and ear clip sensors included), 2 Hans Rudolph 7450

Oro Nasal face masks (S and M), SentrySuite software, standard cart and arm with adjustable height and left/right mousepad, validated WIN 10 PC with sanitizable medical keyboard/mouse, 34 inch flat panel monitor, Office Jet printer, 3-L manual syringe, O2, DLCO and calibration gas regulators, 6 cylinder gas stand, 1 box of MicroGard IIB and IIC (80 each) filters. Tests performed: Spirometry (FVC, SVC, MVV), Lung subdivisions (FRC-N2, RV, TLC), Real-time DLCO (both Single Breath and Intrabreath, MIP/ MEP, pre/post bronchodilator, and CPET (O2, CO2, VE, thresholds, and slopes, compare tests). Standard software includes: Guidance and Stabilitrac instructional applications, preformatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates, CPET screen layout and protocol editor. 1st year warranty included. Not included: Cardiosoft 12 lead ECG (29838-001), Ergometer (30244-001) and/or treadmill (25382-001), and Automated blood pressure cuff (25384-001).

0007

Vyaire

V-707326

DVT VOLUME SENSOR, COMPLETE, VYNTUS CPX

0008

Vyaire

29832-001

LASER PRINTER KIT, COLOR, VYNTUS

0009

Vyaire

23884-001

6.73 GE OPTION, PDF REPORT PDF report creation and export: Auto-formats selected or customized final reports into PDF documents for storage, archiving or offline use. (EPDF)

0010

Vyaire

29838-001

CARDIOSOFT ECG FOR VYNTUS - 12 lead EKG for use with Vyntus CPX or Vyntus One.

0011

Vyaire

31783-001

VYNTUS ONE-PFT PC System. Includes analyzer module (O2,

CO2, Multigas), breathing circuit (including Ultrasonic sensor,

Flow Path Valve, and Demand Valve), SentrySuite software,

standard cart and arm with adjustable height and left/right

mousepad, validated WIN 10 PC with sanitizable medical

keyboard/mouse, 27 flat panel infinity-edge monitor, Office Jet

printer, 3-L manual syringe, O2, DLCO and calibration gas

regulators, 6 cylinder gas stand, 1 box of MicroGard IIB and IIC

(80 each) filters. Tests performed: Spirometry (FVC, SVC, MVV),

Lung subdivisions (FRC-N2, RV, TLC), Real-time DLCO (both

Single Breath and Intrabreath), MIP/MEP, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports, and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1st year warranty included.

0012

Vyaire

31803-001

VYNTUS BODY DIFF ADD Diffusion system, no PC, no cart.

System will connect to shared computer and license of

SentrySuite. Includes: 1110L body plethysmograph with 551

pound patient bench and 25 inch telescoping arm, breathing

circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve), SentrySuite software, 3-L manual syringe, DLCO pressure regulator. On board analyzers to perform in box: Spirometry (FVC, SVC, MVV), Lung subdivisions (VTG, FRCpl, RV, TLC, Raw, Conductance and specific resistance and Resistance Volume Loops), Real-time DLCO (both Single Breath and Intrabreath), MIP/MEP, and pre/post bronchodilator. 1st year warranty included.

0013

Vyaire

V-720000

JQM SYRINGE FOR VA-TEST - Quality control tool for DLCO linearity.

0014

Vyaire

32924-001

Additional Breathing Circuit for Vyntus ONE. Includes: 1 each of

USS Module with polytube adapter, Flow Path Valve, Shutter, and 1 pk of 5 Silicone Valves.

0015

Vyaire

31810-001

VYNTUS ONE-PFT MOBILE System. Includes analyzer module

(O2, CO2, Multigas), breathing circuit (including Ultrasonic

sensor, Flow Path Valve, and Demand Valve), SentrySuite

software, mobile cart (including adjustable arm, supplies drawer, and integrated 3-cylinder gas tank holder), validated WIN 10

laptop, Office Jet printer, 3-L manual syringe, O2, DLCO and

calibration gas regulators, 1 box of MicroGard IIB and IIC (80

each) filters. Tests performed: Spirometry (FVC, SVC, MVV),

Lung subdivisions (FRC-N2, RV, TLC), Real-time DLCO (both

Single Breath and Intrabreath), MIP/MEP, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1st year warranty included.

0016

Vyaire

31790-001

VYNTUS ONE-DL PC System. Includes analyzer module,

breathing circuit (including Ultrasonic sensor, Flow Path Valve,

and Demand Valve), SentrySuite software, standard cart and arm with adjustable height and left/right mousepad, validated WIN 10 PC with sanitizable medical keyboard/mouse, 27 flat panel infinityedge monitor, Office Jet printer, 3-L manual syringe, DLCO and calibration gas regulators, 6-cylinder gas stand, 1 box of MicroGard IIB and IIC (80 each) filters. Tests performed:

Spirometry (FVC, SVC, MVV), Real-time DLCO (both Single

Breath and Intrabreath), MIP/MEP, pre/post bronchodilator.

Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1 year warranty included.

0017

Vyaire

31817-001

VYNTUS ONE-DL MOBILE L/T System. Includes analyzer checks and physician interpretation templates, module, breathing circuit (including Ultrasonic sensor, Flow Path Valve, and Demand Valve), SentrySuite software, mobile cart (including adjustable arm, supplies drawer, and integrated 3- cylinder gas tank holder), validated WIN 10 laptop, Office Jet printer, 3-L manual syringe, DLCO and calibration gas regulators,

1 box of MicroGard IIB and IIC (80 each) filters. Tests performed: Spirometry (FVC, SVC, MVV), Real-time DLCO (both Single Breath and Intrabreath), MIP/MEP, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates. 1 year warranty included.

0018

Vyaire

29820-001

VYNTUS CPX CARDIOSOFT ECG BIG CINEMA. Vmax Vyntus

CPX metabolic cart system for the measurement of O2, CO2 and associated parameters combined with Cardiosoft Stress 12-lead ECG. System includes: 1 Vmax Vyntus CPX analyzer module, 1 Cardiosoft 12-Lead ECG, 1 Nonin SpO2 (with reflectance, ear clip, and adult and pediatric finger sensors), 1 3.0 cart with medical grade isolation transformer, 1 validated Win 10 PC, 1 34 inch curved monitor, 1 Dell color laser printer kit, 1 receiver for Polar HR (Polar belt not included), 1 ambient module, 1 regulator, 2 complete DVT volume sensors (transducer and volume sensor insert), 2 additional volume sensor inserts, 4 Twin Tube bxb sample lines, 2 Hans Rudolph 7450 Oro Nasal face masks (S and M), 1 SentrySuite software with MS SQL Server Software 2014 and license code sheet, nose clips, and 2 boxes MicroGard 2 filters (50 ea.). 2 years Premium Care warranty. Not included: Ergometer (30244-001) and/or treadmill (25382-001) and Automated blood pressure cuff (25384-001).

0019

Vyaire

30244-001

VIASPRINT BIKE WITH BP AND CUFFS. Electromagnetically braked bicycle ergometer especially designed for exercise tests

with integrated blood pressure. Load 20-999 watts, revolution

range 30-130 rpm, and integrated isolation transformer. 3 cuff

sized are supplied- small, standard, and large. Blood pressure

may be initiated via software or manually from display unit head.

Manual adjustment of saddle height from 120-210 cm and

adjustable handlebar. Dimensions (L 35.4-inch x W 18.1-inch x H 52.4 inch), bike weight 134.5 lbs., power supply 90-264V. The

ergometer is certified for a maximum weight of 308 lbs.

0020

Vyaire

31428-001

Ergoselect 600P. Microprocessor controlled recumbent ergometer constructed and approved for weight up to 300 kg. Includes 6-999 W load, 30-130 rpm, 54 cm seat width, with adjustable back rest and adjustable width pedal shoes. L 65 in x W 30 in x h 42 in, 190 lbs., 90-265 V. One year warranty.

0021

Vyaire

31427-001

Ergoselect 600P with BP Microprocessor controlled recumbent ergometer with Blood Pressure constructed and approved for weight up to 300 kg. Includes 6-999 W load, 30-130 rpm, 54 cm seat width, S, M, and L BP cuffs, adjustable back rest, and adjustable-width pedal shoes. L 65 in x W in cm x h 42 in, 190 lbs., 90-265 V. One year warranty.

0022

Vyaire

25382-001

TRACKMASTER TMX428CP TREADMILL Trackmaster medical

treadmill with Programmable controller. User Weight capacity of 500lbs, 22-inch x 63 inch running surface. Electrical Requirements: 208-240Vm 50/60 Hz, dedicated 15A service.

0023

Vyaire

25384-001

TANGO M2 KIT, VMAX Tango M2 non-invasive blood pressure

monitor for resting and exercise stress testing BP. Includes Tango with ECG, 4 adult cuff sizes, and all cables necessary for

connection with the Vmax Encore stress testing systems and PC.

0024

Vyaire

V-375650

OPTION HIGH/LOW FIO2 VYNTUS CPX, Hardware and software kit includes software code sheet, 1 complete Hans Rudolph (HR) Y-Valve 2730, 1 DVT for Hi/Low FiO2, 1 HR Inhaler Adapter, 1 Filling Assembly, 1 of each (coupling hose from bag to gas tank, Reducing Nipple for hose to connect to bag or reducer, O-Ring D 18, Reducer Assembly, and O-Ring D 21), and 1 Breathing Bag 20L 30PK. Option does not include gas, regulator, or blender.

0025

Vyaire

29819-001

VYNTUS CPX METABOLIC CART 24-inch MONITOR. Vmax

Vyntus CPX metabolic cart system for the measurement of O2,

CO2 and associated parameters. System includes: 1 Vmax

Vyntus CPX analyzer module, 1 Nonin SpO2 (with reflectance,

ear clip, and adult and pediatric finger sensors), 1 3.0 cart with

medical grade isolation transformer, 1 validated Win 10 PC, 1 Dell 24 inch monitor, 1 Dell color printer, 1 receiver for Polar HR (Polar belt not included), 1 ambient module, 1 regulator, 2 complete DVT volume sensors (transducer and volume sensor insert), 2 additional volume sensor inserts, 4 Twin Tube bxb sample lines, 2 Hans Rudolph 7450 Oro Nasal face masks (S and M), 1 SentrySuite software with MS SQL Server Software 2014 and license code sheet, nose clips, and 2 boxes MicroGard 2 filters (50 ea.). 2 years Premium Care warranty. Not included: 12 lead ECG (29838-001), Ergometer (30244-001) and/or treadmill (25382-001), and Automated blood pressure cuff (25384-001).

0026

Vyaire

464695

RS232 Cable to PC, Case or CardioSoft to Suntech Tango Non-

Invasive BP Monitor

0027

Vyaire

V-859142-13

VYNTUS BASIC CART, Portable laptop cart for Vyntus SPIRO.

Includes: drawer for paper or other small items, syringe holder, transport handle, mouse tray that will accommodate the mouse on left or right side, basket for filters, shelf on bottom for optional printer. Unpacking and setup by our field service

team can be purchased separately.

0028

Vyaire

34571-001

LAPTOP LOCK-KEYED

0029

Vyaire

25626-001

VYNTUS SPIRO LAPTOP. PC Based Spirometer with direct USB connection to Laptop Computer. Validated Windows 10 Laptop Computer Included. Vyntus Spiro performs all the essential spirometry tests; FVC with Flow Volume Loop, Slow Vital Capacity (SVC), Maximum Voluntary Ventilation (MVV). Pre and Post Bronchodilator testing levels and Bronchial Challenge Testing software also included. SentrySuite software provides user guidance and feedback regarding test quality according to ATS/ERS or other author's standards. Other software features included; powerful report designer, 10 parameter-linked animated incentives, interactive guided calibration, customizable reference modules, and offline data entry. Device can be used as standalone or can take advantage of our growing family of SentrySuite solutions for workflow and

connectivity such as Sentry.Net and SentryConnect. Box of 80

Microgard filters included. 1-year complete warranty included. Not included: Printer (29225-001), Syringe 3 Liter Manual Calibration (720254), USB Ambient module (V-378560), Vyntus Basic Cart (V-859142-13), Laptop Lock-keyed (34571-001), and Installation (34588-101).

0030

Vyaire

29225-001

KIT, OFFICE JET PRINTER

0031

Vyaire

720254

SYRINGE 3 LITER MANUAL CALIBRATION

0032

Vyaire

33120-001

VYNTUS SPIRO PNEUMOTACH/ELBOW KIT Pneumotach supply kit for Vyntus SPIRO. Contains 4 pneumotachs and 5 elbows.

0033

Vyaire

34588-101

SERVICE-RDX-SM DEVICE FIELD INSTALL-1ST DEVICE

0034

Vyaire

V-378560

USB AMBIENT MODULE

0035

Vyaire

25627-001

VMAX VYNTUS SPIRO DESKTOP. PC Based Spirometer with

direct USB connection to Desktop PC. Validated Windows 10

Desktop PC, 22" MONITOR and Sound Bar Included. Vmax

Vyntus Spiro performs all the essential spirometry tests; FVC with Flow Volume Loop, Slow Vital Capacity (SVC), Maximum

Voluntary Ventilation (MVV). Pre and Post Bronchodilator testing levels and Bronchial Challenge Testing software also included. SentrySuite software provides user guidance and feedback regarding test quality according to ATS/ERS or other author's standards. Other software features included; powerful report designer, 10 parameter-linked animated incentives, interactive guided calibration, customizable reference modules, and offline data entry. Device can be used as standalone or can take advantage of our growing family of SentrySuite solutions for

workflow and connectivity such as Sentry.Net and SentryConnect. Box of 80 Microgard filters included. 1-year complete warranty included. Not included: Printer (29225-001), Syringe 3 Liter Manual Calibration (720254), USB Ambient module (V-378560), and Installation (34588-101).

0036

Vyaire

V-178501

VYNTUS WALK TABLET WITH SPO2

Training

0037

Vyaire

34552-142

SERVICE-RDX-SM DEVICE PFT FUNDMTLS TRG-2 DAYS CUST HOSTED This 2-day program provides training for up to 2 small PFT devices (e.g., Vyntus SPIRO, Vyntus WALK, MasterScreen PNEUMO, MasterScreen IOS) or 1 small PFT device and Bronchial Challenge Testing. Provides training at a single customer location for up to 4 participants. Provides 14 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device.

0038

Vyaire

34553-142

SERVICE-VYN-LG DEVICE PFT FUNDMTLS TRG-2 DAYS CUST HOSTED This 2-day course is designed to teach PFT operators how to perform quality diagnostic tests using the Vyntus pulmonary function testing devices. Provides training at a single customer location for up to 4 participants. Provides 14 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device.

0039

Vyaire

34553-143

SERVICE-VYN-PFT FUNDMTLS TRG-3 DAYS-CUST HOSTED

This 3-day course is designed to teach PFT operators how to

perform quality diagnostic tests using the Vyntus pulmonary

function testing devices. Provides training at a single customer

location for up to 4 participants. Provides 21 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device.

0040

Vyaire

34553-144

SERVICE-VYN-PFT FUNDMTLS TRG-4 DAYS-CUST HOSTED

This 4-day course is designed to teach PFT operators how to

perform quality diagnostic tests using the Vyntus pulmonary

function testing devices. The fourth day of training provides

participants with a supplemental training day for additional side-by- side practice with the Clinical Educator. This Program provides training at a single customer location for up to 4 participants and 28 AARC CRCE contact hours for each of the 4 participants when training is purchased in conjunction with a new device.

0041

Vyaire

34554-142

SERVICE-VYN-CPET FUNDMTLS TRG-2 DAYS-CUST HOSTED This 2-day course is designed to teach novice CPET operators how to perform fundamental exercise testing using the Vyntus ONE and/or Vyntus CPX medical device and SentrySuite software. Provides training at a single customer location for up to 4 participants. Provides 14 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device.

0042

Vyaire

34554-143

SERVICE-VYN-CPET FUNDMTLS TRG-3 DAYS-CUST HOSTED This 3-day course is designed to teach novice CPET operators how to perform fundamental exercise testing using the Vyntus ONE and/or Vyntus CPX medical device and SentrySuite software. Provides training at a single customer location for up to 4 participants. Provides 21 AARC CRCE contact hours for 4 participants when training is purchased in conjunction with a new device.

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Gases/Regulators

0043

Vyaire

768093

DLCO GAS .3%CO .3%CH4 21%02 BAL N2 (ED)

0044

Vyaire

V-892590-13

Vyntus Calibration GAS 16%O2 5%CO2 0.3%CO/CH4/BAL N2 E CYL

0045

Vyaire

761819

GAS- 99.00% OXYGEN(USP)

0046

Vyaire

773867

Vyntus CPX Calibration GAS 16%O2 4%CO2 BAL N2 8D CYL

0047

Vyaire

673666

Vyntus CPX Calibration GAS 16% 02 4% C02 BAL N2 CGA973 FTG

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IOS

0048

Vyaire

27271-001

MS IOS SES WITH LAPTOP. MasterScreen IOS system,

SentrySuite software, validated WIN 10 laptop computer, color

desk jet printer included. Tests performed- quiet breathing Airways Resistance, Forced Vital Capacity, Slow Vital Capacity and Maximum Voluntary Ventilation, pre/post bronchodilator. Standard software includes: Guidance and Stabilitrac instructional applications, pre-formatted reports and reference sets with design tools for modification, automated interpretation algorithms, QA checks and physician interpretation templates, Patient Data management, multiformat output, SeS SQL DB interface for queries. Device can be used as standalone or can take advantage of our growing family of SentrySuite solutions for workflow and connectivity such as Sentry.Net and SentryConnect. 3-liter calibration syringe included. Box of 80 Microgard filters included. 1-year complete warranty.

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Network

0049

Vyaire

33284-001

SENTRYSUITE WORKFLOW BASIC - CONNECTION TO SOMNOWARE The SentrySuite Workflow Basic package includes the standard SentrySuite workflow, set up of a network SQL database, standard predicted sets, the full SentrySuite report library, a custom report header and footer, and self-help tools for migrating data from existing Vyaire devices. This package also includes a bi-directional interface to the EMR to incorporate inbound ADT or ORM and an outbound PDF report; facilitator-led web-based advanced workflow training to cover an EMR workflow process; role-based security; a test workstation license; and a Vyaire Project Manager to guide the Pulmonary Lab through the project to completion. This package does not include custom workflow, custom predicted sets, custom reports, or outbound discrete data elements.

0050

Vyaire

V-577201-100

SENTRYCONNECT SEAT LICENSE FOR SES Single Seat

license to connect to SentryConnect gateway- SentrySuite

instrument, SentrySuite reading station, Sentry.NET remote

access.

0051

Vyaire

33287-001

PROFESSIONAL SERVICES -- CUSTOMIZED REPORTS

Provides a Vyaire Professional Services resource to create

custom reports within the existing environment. Limited to a single round of customization/revisions with final sign off by customer. Once the customized reports are signed off by the facility, future revisions to those same reports will be subject to additional charges.

0052

Vyaire

34352-101

SERVICE-SES-CLIENT/DEVICE SW MGMT-1 YEAR Maintains

SentrySuite/Vmax software application on workstation(s);

provides proactive notification of maintenance package releases

for bug fixes and cybersecurity updates; provides software

upgrades when available; provides direct phone line into

Professional Services; provides priority response and resolution

for calls into Professional Services; supports report and predicted set customization.

0053

Vyaire

34352-301

SERVICE-SES-INTERFACE WORKFLOW SUPPORT-1 YEAR

Maintains SentrySuite/Vmax application services and databases

(including IT test environment, administrative, and reading stations); maintains Mobile Review; maintains bi-directional

interface with EMR system; supports issue resolution and testing

requirements due to EMR system updates; support server

migration; provides administrative maintenance web-based

training for super users; provides proactive notification of

maintenance package releases for bug fixes and cybersecurity

updates; provides software upgrades when available; provides

direct phone line into Professional Services; provides priority

response and resolution for calls into Professional Services;

supports report and predicted set customization.

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Accessories

0054

Vyaire

V-861935

FPV HOUSING CLAMP VYNTUS ONE

0055

Vyaire

923015

OXYGEN-SENSOR TYPE UFO-140, VYNTUS CPX

0056

Vyaire

V-707326

DVT VOLUME SENSOR, COMPLETE, VYNTUS CPX

0057

Vyaire

29856-001

34'' CURVED ULTRAWIDE MONITOR

0058

Vyaire

V-707744

FPV SHUTTER MECHANISM, C SHAPE

0059

Vyaire

V-707722

VYNTUS ONE SAMPLE LINE

0060

Vyaire

V-707388

FPV SHUTTER MECHANISM

0061

Vyaire

V-707389

FPV BLOCK (TOP PARTS FPV)

0062

Vyaire

V-852556

DRYING TUBE ME SERIES,48IN

0063

Vyaire

V-982186

ORO NASAL 7450 V2 MASK W/HG SIZE L

0064

Vyaire

V-982185

ORO NASAL 7450 V2 MASK W/HG SIZE M

0065

Vyaire

V-982184

ORO NASAL 7450 V2 MASK W/HG SIZE S

0066

Vyaire

V-982187

ORO NASAL 7450 V2 MASK W/HG SIZE XS

0067

Vyaire

V-982188

ORO NASAL 7450 V2 MASK W/HG SIZE XXS

0068

Vyaire

V-707327

TWIN TUBE SAMPLE LINE, VYNTUS CPX 2.40M

0069

Vyaire

V-861078

ADAPTER JAEGER CONE, DVT VYNTUS CPX

0070

Vyaire

001-982094

ROTARY FLOW SENSOR FOR TRIPLE V

0071

Vyaire

V-707746

VOLUME SENSOR INSERT/SINGLE USE DVT 50PK

0072

Vyaire

V-861109

Y-VALVE 2730 HR FOR CPET, Complete Hans Rudolph one-way breathing kit

The Department of Veterans Affairs (VA) is seeking vendors who can provide Vyaire® Cardiopulmonary Diagnostic Systems or equal as listed above which meet all of 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.

SC #

Salient Characteristics

Method Of Evaluation

Location in Technical Literature Where SC is Met

SC 1

Must offer a combination of system components necessary to perform Pulmonary Function Testing (PFT) and Cardiopulmonary Exercise Testing (CPET).

Literature Review

SC 2

Must interface with the VA national Somnoware platform for Sleep and Pulmonary interpretation ensuring compatibility and data exchange within the VA healthcare network.

Literature Review

SC 3

Individual components must connect to a computer system with software to perform all required testing calculations and generate a customizable report.

Literature Review

SC 4

Must meet the American Thoracic Society (ATS) and American Association of Respiratory Care (AARC) standards.

Literature Review

Vendors may propose any product solution or configuration so long as they meet the salient characteristics. Products proposed in the technical volume must be captured on the Vendor s pricing volume (Attachment A - Price Cost Schedule) of the solicitation. Vendors may propose 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.

INSTALLATION

Not Applicable for this requirement. Stand-alone equipment doesn t require installation.

SOFTWARE INSTALLATION AND UPDATES

SERVICE-SES-INTERFACE WORKFLOW SUPPORT-1 YEAR. Maintains Sentry Suite/Vmax application services and databases (including IT test environment, administrative, and reading stations); maintains Mobile Review; maintains bi-directional interface with EMR system; supports issue resolution and testing requirements due to EMR system updates; support server migration; provides administrative maintenance web-based training for super users; provides proactive notification of maintenance package releases for bug fixes and cybersecurity updates; provides software upgrades when available; provides direct phone line into Professional Services; provides priority response and resolution for calls into Professional Services; supports report and predicted set customization.

Coverage exclusions:

Windows upgrades, hardware replacements, spare parts, on-site service, field service repair, work performed outside normal business hours (7 am to 7 pm CT), IT support for problems not caused by or the result of an issue with Vyaire equipment or software, and requests for customization outside contract scope (e.g., custom database scripts and discrete data filters).

Customers should have their contract number ready when they call. Calls will be returned on the same day by the next available resource if a voicemail is left. For hardware related assistance, customer must continue to contact Technical Support at 800.231.2466. Calls into the Professional Services contract line

are limited to support for contract benefits.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer s specifications. Maintenance, repairs and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC.

PRODUCT REFRESHÂ Â

Product refresh is when a current CLIN is no longer being manufactured due to

obsolescence and the product item is being replaced with a newer, and more often, a

superior version of the same item. The current CLIN product will be revised to reflect the

refreshed product information, manufacturer s part number, IDIQ price (inclusive of

Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under

product refresh. The contractor will be notified in writing if a product refresh is not

accepted. All products offered shall be provided with the warranty that is agreed upon

for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products

meet American with Disabilities Act (ADA) and Health Information Portability and

Accountability Act (HIPAA) Federal requirements, see attachment 5.

The contractor shall provide the COR and CO the following information for product

refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule

(to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA

fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared

to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to

those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government. The manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer

Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from

customers and the contract number assigned as a result of an issuance on

the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective

action.

A copy of the notification will be provided to:

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this Combined Synopsis/Solicitation Notice.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT E SALES REPORTING TOOL - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT F - PAST PERFORMANCE REFERENCE - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX EQ CARDIOPULMONARY DIAGNOSTIC SYSTEMS.

See attached document: Attachment 1 Cardiopulmonary Diagnostic Systems CLINs Structure

See attached document: Attachment 2 VA Handbook 6500.6