6515-- Vyntus System

5. PROJECT NUMBER (if applicable) CODE 7. ADMINISTERED BY 2. AMENDMENT/MODIFICATION NUMBER CODE 6. ISSUED BY 8. NAME AND ADDRESS OF CONTRACTOR 4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE 9A. AMENDMENT OF SOLICITATION NUMBER 9B. DATED PAGE OF PAGES 10A. MODIFICATION OF CONTRACT/ORDER NUMBER 10B. DATED BPA NO. 1. CONTRACT ID CODE FACILITY CODE CODE Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers E. IMPORTANT: is extended, (a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended. 12. ACCOUNTING AND APPROPRIATION DATA (REV. 11/2016) is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A. 15C. DATE SIGNED B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b). RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF: D. OTHER Contractor 16C. DATE SIGNED 14. DESCRIPTION OF AMENDMENT/MODIFICATION 16B. UNITED STATES OF AMERICA Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect. 15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER 15B. CONTRACTOR/OFFEROR STANDARD FORM 30 PREVIOUS EDITION NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.) (Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.) (If required) (SEE ITEM 11) (SEE ITEM 13) (X) CHECK ONE 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS, IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. 11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT (Signature of person authorized to sign) (Signature of Contracting Officer) 1 9 0002 08-19-2020 PR 605-20-4-077-0670 00262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 00262 Department of Veterans Affairs Network Contracting Office 22 4811 Airport Plaza Drive Suite 600 Long Beach CA 90815 To all Offerors/Bidders 36C26220Q1236 08-19-2020 X X X 1 08-25-2020 at 11:00 AM PDT See CONTINUATION Page X 1 The purpose of this Amendment is as follows: 1. To DELETE Line Item 0008 and Line Item 0009 2. To ADD Line Item 0022 and Line Item 0023 3. To update the Salient Characteristics format 4. Submit quotes to Mayra Barbosa at contact@example.gov 5. See subsequent pages for changes All other terms and conditions remain unchanged. Adriana Garcia Contracting Officer CONTINUATION PAGE A.1 PRICE/COST SCHEDULE ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 2.00 EA __________________ __________________ Vyntus ONE PFT System. ITEM# 31788-001 LOCAL STOCK NUMBER: 31788-001 0002 2.00 EA __________________ __________________ GAS .3%CO .3%CH4 21%02 BAL N2 (ED). ITEM# 768093 LOCAL STOCK NUMBER: 768093 0003 1.00 EA __________________ __________________ GAS- 99.00% OXYGEN(USP)... ITEM# 761819 LOCAL STOCK NUMBER: 761819 0004 1.00 EA __________________ __________________ GAS 16%O2 5%CO2 0.3%CO/CH4/BAL N2 E CYL... ITEM# V-892590-13 LOCAL STOCK NUMBER: V-892590-13 0005 1.00 EA __________________ __________________ PULMONARY OR EXERCISE ONSITE TRAINING 3 DAYS. ITEM# 97075-PM3-OS LOCAL STOCK NUMBER: 97075-PM3-OS 0006 1.00 EA __________________ __________________ SES CLIENT Device to be configured as a network client... ITEM# 28567-001 LOCAL STOCK NUMBER: 28567-001 0007 1.00 EA __________________ __________________ VYNTUS BODY DIFF ADD 5PR SYSTEM Whole Body Plethysmograph ITEM# 31808-001 LOCAL STOCK NUMBER: 31808-001 0008 0.00 EA __________________ __________________ *** LINE ITEM DELETED 0009 0.00 EA __________________ __________________ *** LINE ITEM DELETED 0010 1.00 EA __________________ __________________ GAS .3%CO .3%CH4 21%02 BAL N2 (ED)... ITEM# 768093 LOCAL STOCK NUMBER: 768093 0011 1.00 EA __________________ __________________ GAS 16%O2 5%CO2 0.3%CO/CH4/BAL N2 E CYL... ITEM# V-892590-13 LOCAL STOCK NUMBER: V-892590-13 0012 1.00 EA __________________ __________________ SES CLIENT Device to be configured as a network client... ITEM# 28567-001 LOCAL STOCK NUMBER: 28567-001 0013 1.00 EA __________________ __________________ Vyntus ONE System for PFT and CPET testing. ITEM# 31781-001 LOCAL STOCK NUMBER: 31781-001 0014 1.00 EA __________________ __________________ GAS .3%CO .3%CH4 21%02 BAL N2 (ED)... ITEM# 768093 LOCAL STOCK NUMBER: 768093 0015 1.00 EA __________________ __________________ GAS- 99.00% OXYGEN(USP)... ITEM# 761819 LOCAL STOCK NUMBER: 761819 0016 1.00 EA __________________ __________________ GAS 16%O2 5%CO2 0.3%CO/CH4/BAL N2 E CYL... ITEM# V-892590-13 LOCAL STOCK NUMBER: V-892590-13 0017 1.00 EA __________________ __________________ TANGO M2 KIT, VMAX Tango M2 non-invasive blood pressure monitor... ITEM# 25384-001 LOCAL STOCK NUMBER: 25384-001 0018 1.00 EA __________________ __________________ CARDIOSOFT ECG FOR VYNTUS... ITEM# 29838-001 LOCAL STOCK NUMBER: 29838-001 0019 1.00 EA __________________ __________________ EXT WARRANTY CARDIOSOFT 4 YR CardioSoft Extended Warranty 4 Year... ITEM# 769585-ECG-104 LOCAL STOCK NUMBER: 769585-ECG-104 0020 1.00 EA __________________ __________________ PULMONARY OR EXERCISE ONSITE TRAINING 3 DAYS ITEM# 97075-PM3-OS LOCAL STOCK NUMBER: 97075-PM3-OS 0021 1.00 EA __________________ __________________ SES CLIENT Device to be configured as a network client... ITEM# 28567-001 LOCAL STOCK NUMBER: 28567-001 0022 3.00 EA __________________ __________________ Additional breathing circuit for Vyntus one. Item 32924-001 0023 1.00 EA __________________ __________________ Ext war-tango parts only. Item 97018-104 0024 1.00 __________________ __________________ Additional breathing circuit for the Vintus body. Item: 32925-001 GRAND TOTAL __________________ A.2 SALIENT CHARACTERISTICS Salient Characteristics 1. Pulmonary Function Testing (FPT) and Cardiopulmonary Stress Testing in a single device. 1.1. Contain a Spirometry ( FVC, FEV1, Flow Volume Loop) and Slow Vital Capacity ( SVC, ERV, IC) 1.2. Must have a Maximum Voluntary Ventilation (MVV). 1.3. CO-Diffusion SB Real-time: with continuous, high speed gas analysis for calculation of DLCO, VA, DL/VA. 1.4. Contain a CO Diffusion Intrabreath or equal: an alternative diffusion method with a non-breath hold maneuver with continuous, high speed gas analysis for calculation of DLCO, VA, DL/A etc. 1.5. Lung Volumes: using the N2 washout method for FRCN2, ERV, RV, TLC, VC, IC and determination of the Lung Clearance Index (LCI). 1.6. Must have a Pre and post medication testing for therapy control. 1.7. Maximal Inspiratory and Expiratory Pressures (MIP/MEP) 1.8. Bronchial Challenge Testing 1.9. Contain an approved Breath by Breath Exercise Testing 2. Hardware: 2.1. The main unit must contain all gas analyzers (CO/CH4/O2/CO2) in one module. 2.2. Fast Multigas analyzer (CO/CH4) for the Diffusion measurements with response time <150ms. 2.3. Must have a Fully digital, high speed O2 analyzer, based on electrochemical principle. 2.4. Must be fully digital, high speed CO2 analyzer, based on infrared absorption 2.5. O2 cell must be exchangeable without opening the analyzer unit 2.6. Automatic gas calibration for calibration of all gases must be within one minute to complete. 2.7. Must have an USB ambient module for continuously reading ambient data temperature, humidity and barometric pressure. 2.8. Factory Calibrated Ultrasonic sensor with 1000Hz sampling rate and double shot technology. Volume accuracy of 2.5%, meeting 2017 ATS/ERS DLCO guidelines. 2.9. Ultrasonic flow sensor must be waterproof 2.10. Shutter system must be free of balloons 2.11. Must contain an Electronically controlled gas demand valve for proper gas flow. 2.12. Must be capable of validating bacterial/viral applicable filters to include complete hygiene documentation and concept. 2.13. Must contain Breath by breath measurement CPET measurement system or equal. 2.14. Must be equipped with Digital bidirectional volume sensor suited for CPET testing and weighing no more than 45g 2.15. System must have CPET Volume sensor offered with both reusable and disposable concepts. 2.16. Sp02-sensor must directly connectable to analyzer 2.17. Height of cart must be able adjustable for sitting and standing position to accommodate the needs of the technician 2.18. Adjustable arm for measuring in sitting and standing position to accommodate personnel. 2.19. Keyboard and mouse must be sealed to prevent spread of bacteria. 3. General software functions must consist of the following: 3.1. Software must be in compliance with ATS/ERS guidelines including the 2017 DLCO and Reporting guidelines. 3.2. Digital Questionnaire must be integrated into patient record. 3.3. Contain mobile review application to allow physicians to interpret testing from any device. 3.4. System must be capable of integrated digital signature for reports 3.5. Capable of reporting output format selectable as print, monitor view, PDF, TIFF, RTF, JPG 3.6. Support online coaching for technician and patient 3.7. Quality feedback must be based on ATS/ERS guidelines 3.8. Capability of having GLI reference and ability to create custom user sets and equations. 3.9. Contain the capability of facilitating different patient types for BIO QC, QM validation and BIO controls to help keep Internal quality control data separated from patient data. 3.10. Contain exercise protocol due to reference values and spirometry data. 3.11. Be able to edit and post exercise test evaluation workflow steps. 4. Salient Characteristics: Body of System. 4.1. Must consist of a Spirometry (FVC, FEV1, Flow Volume Loop) and Slow Vital Capacity ( SVC, ERV, IC) 4.2. Contain a Maximum Voluntary Ventilation (MVV). 4.3. CO-Diffusion SB Real-time: with continuous, high speed gas analysis for calculation of DLCO, VA, DL/VA. 4.4. CO Diffusion Intrabreath: an alternative diffusion method with a non-breath hold maneuver with continuous, high speed gas analysis for calculation of DLCO, VA, DL/A. 4.5. Consist of a Pre and post medication testing for therapy control. 4.6. System must have a Maximal Inspiratory and Expiratory Pressures (MIP/MEP) or equal. 4.7. Ability to analyze the Bronchial Challenge Testing 4.8. Contain Lung Volumes and Airway Resistance by Body Plethysmography programs (TLC, FRC, sRaw.) 5. Hardware: 5.1. System must be made of glass cabin with open vision on all four sides to monitor patient safety 5.2. Contain at least a 1100L Volume Cabin 5.3. Door must contain an Electromagnetic door closure that does not require any gas pressure to seal cabin. 5.4. Door must be capable of being opened by patient via release button inside the cabin 5.5. Handgrip must be stable for safety of the patient to allow easy entry and exit 5.6. Bench must be capable of withstanding at a minimum of 551lbs. 5.7. Flexible, telescoping arm that extends 25 outside the cabin to test patients in wheelchairs or for whatever reason cannot enter the cabin. 5.8. Low entry step must be is less than 3 for patient safety 5.9. Contain a Digital Pressure Compensation 5.10. Must have a minimum of 3 frequency calibration 5.11. Contain a LED status lights for durability 5.12. Fast Multigas analyzer (CO/CH4) for the Diffusion measurements with response time <150ms. 5.13. Fully digital, high speed CO2 analyzer, based on infrared absorption for accuracy 5.14. Must have single gas tank, as space is limited in the facility. 5.15. Must contain an USB ambient module for continuously reading ambient data temperature, humidity and barometric pressure. 5.16. Factory Calibrated Ultrasonic sensor with 1000Hz sampling rate and double shot technology. Volume accuracy of 2.5%, meeting 2017 ATS/ERS DLCO guidelines. 5.17. Ultrasonic flow sensor must be waterproof for cleaning and disinfection. 5.18. Magnetically-controlled shutter system must reduce dead space to meet ATS standards. 5.19. Shutter system must be free of balloons 5.20. Must have the capability to validated bacterial/viral filters, along with complete hygiene documentation and concept. 5.21. Optional Height adjustable cart for sitting and standing position to accommodate the needs of the technician 5.22. Keyboard and mouse must be sealed so that it can be cleaned and disinfected. 6. General software functions: 6.1. Must be in compliance with ATS/ERS guidelines including the 2017 DLCO and reporting guidelines. 6.2. Contain Resting and Panting testing techniques 6.3. Digital Questionnaire must be able to integrate into the patient record. 6.4. Web based Mobile review application to allow physicians to interpret testing from any device. 6.5. Capability of processing digital signature for reports 6.6. Capable of reporting output format selectable as print, monitor view, PDF, TIFF, RTF, JPG 6.7. Ability to upload PDF s into any patient visit and add comments to them for inclusion in workflow 6.8. Must be able to have access to online coaching for technician and patient 6.9. Quality feedback must be based on ATS/ERS guidelines 6.10. GLI reference must have the ability to create custom user sets and equations. 6.11. Different patient types for BIO QC, QM validation and BIO controls to help keep Internal quality control data separated from patient data must be part of the system. 6.12. Must contain a centralized network administration and monitoring. The information identified above is intended to be descriptive, not restrictive and to indicate the quality that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the brand name or equal to supplies being requested. 7. Vendor Requirements: 7.1. Vendor shall provide delivery (Destination) 7.2. Vendor shall provide manufacture standard warranty on the product starting from the first day of delivery. 7.3. The pricing terms and conditions of the quotation shall be valid for at least 90 days unless a longer time is stated in the quote. 7.4. All Items quoted must be new. 8. WARRANTY Vendor shall provide standard warranty for these products. 9. DELIVERY Vendor must deliver to VA Loma Linda. Delivery 30 Days, After Receipt of Order (ARO) 10. INSPECTION AND ACCEPTANCE The VA Loma Linda will inspect the equipment to ensure serviceability and condition. 11. GRAY MARKET ITEMS No remanufactures or gray market items will be acceptable. Vendor shall be an Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller verified by an authorization letter or other documents from the OEM.