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FedBizOppsCombined Synopsis/Solicitation Notice*******CLASSIFICATION CODESUBJECTCONTRACTING OFFICE'S ZIP-CODESOLICITATION NUMBERRESPONSE DATE (MM-DD-YYYY)ARCHIVE DAYS AFTER THE RESPONSE DATERECOVERY ACT FUNDSSET-ASIDENAICS CODECONTRACTING OFFICE ADDRESSPOINT OF CONTACT(POC Information Automatically Filled from User Profile Unless Entered)DESCRIPTION*See AttachmentAGENCY'S URLURL DESCRIPTIONAGENCY CONTACT'S EMAIL ADDRESSEMAIL DESCRIPTION ADDRESSPOSTAL CODECOUNTRYADDITIONAL INFORMATIONGENERAL INFORMATIONPLACE OF PERFORMANCE* = Required FieldFedBizOpps Combined Synopsis/Solicitation NoticeRev. March 201065(ACT) 436 BILLINGS ACTIVATION IMPEDANCE MANOMETRY PACKAGE80246VA259-15-Q-061109-14-201515N2339112Department of Veterans AffairsNetwork Contracting OfficeNCO 194100 E. Mississippi Avenue, Suite 900Glendale CO 80246Brooke Barkerbrooke.barker@Department of Veterans AffairsBillings Clinic1766 Majestic LaneBillings, MT 5901259012USAThis is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.The solicitation number is: VA259-15-Q-0611, and it is issued as a request for quotation (RFQ).The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-82.This solicitation is set-aside for Small Business. NAICS: 339112.Contract Line Items:ITEMDESCRIPTIONQTY.0001ULT1-H-TD: inSIGHT Ultima High Resolution Impedance Manometry System, OR EQUAL. Includes an inSIGHT Ultima Base unit, HRiM 2 Probe with 32 circumferential pressure sensors & 16 impedance channels (12 FR), BioVIEW Acquisition Software, calibration accessories and cables, computer, 19” Touch-Screen Monitor, Mobility Cart & Printer. Training included. ***See specifications below on page 4-6 ***1 EA0002Z07-2000B-SB: ZepHr I2.5 Z/pH kit- Impedance/pH reflux monitoring kit OR EQUAL. Includes 1 ZepHr Z/pH recorder, software, calibration kit & accessories. ***See specifications below on page 7-8***1 EA0003ZAN-BS-01: ComforTEC Z/pH Single-use Probe, 18cm Esophageal length non-infused, 6 impedance, 1 pH channel, Diameter 6.4FR/2.13mm; OR EQUAL5 EA0004ZAN-BG-44: ComforTEC Z/pH Single use Probe, Gastric, non-infused, 18cm Esophageal length, 6 impedance 2 pH channels -15 & 0, Diameter 6.9FR/2.3mm; OR EQUAL5 EAVendor must be able to provide all of the listed or equal items. The quoted items shall meet or exceed the items listed on the schedule. If an equal product is quoted the vendor shall submit documentation stating why/how their product meets or exceeds each item. Specifications are included on pages 4-8.Delivery (FOB Destination) Department of Veterans AffairsBillings Majestic Clinic1766 Majestic LaneBillings, MT 59102The provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition.The provision at 52.212-2, Evaluation – Commercial Items, does not apply to this acquisition. Evaluation will be made by LPTA. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications – Commercial Items, with the offer.The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition.Any additional contract requirements or terms and conditions: FAR 52.203-99, FAR 52.232-40, FAR 52.247-34, VAAR 852.203-70, VAAR 852.211-73, VAAR 852.232-72, VAAR 852.246-70, VAAR 852.246-71. All Contractors must be registered in to do business with the federal government and annually ensure the information is current at .The Defense Priorities and Allocations System (DPAS) does not apply.Date and Time offers are due: September 14, 2015 by 1200 Mountain Time to brooke.barker@.Name and telephone number of the individual to contact for information regarding the solicitation:Brooke BarkerContract SpecialistBrooke.barker@inSIGHT, or equal, SpecificationsinSIGHT Ultima PlatformA single hardware platform that has the capability for multiple diagnostic testing modules, including:High Resolution Impedance Manometry (HRiM)High Resolution Impedance Manometry Smal Idameter (HRiMSD)High Resolution Manometry (HRM)Anorectal ManometryHigh Resolution Anorectal Manometry (HRAM)Low Resolution Anorectal Manometry (Air-charged)Sphincter of Oddi Manometry (SOM)Solid-stateWater perfusedA single hardware platform capable of supporting multiple technology configurations, including:Solid-stateWater perfusedAir chargedCatheter specific guided protocols with data acquisition software to guide the user through the study leading to reduced study complexity & optimized data consistency.Application specific system cart, including:Hydraulic movement allowing the user to stand when performing a study or in a seated position to analyze the studyIntegrated power isolation transformerLarge lockable storage drawerPrinter shelf24” medical grade touch screen monitorSolid-State Catheter Configurations:High Resolution Impedance Manometry (HRiM):12 FR, with at least 32 true circumferential pressure sensors spaced at 1cm intervals & 16 impedance channels spaced at 2cm intervalsSmall Dianeter High Resolution Impedance Manometry (HRiMSD)8 FR, with at least 32 directional pressure sensors spaced at 1cm intervals & 16 impedance channels spaced at 2cm intervalsHigh Resolution Manometry (HRM)12 FR, with at least 32 true circumferential pressure sensors spaced at 1cm intervalsHigh Resolution Anorectal Manometry (HRAM)12 FR, with at least 23 directional pressure sensors, including 5 rings with 4 sensors positioned Posterior, Left, Anterior, & RightHigh Resolution Anorectal Manometry (HRCA)12 FR, with at least 6 circumferential pressure sensors, linear configuration spaced at 1cm intervalsAll solid state catheters should be protected against submersion in approved cleaning & disinfectionThe system should be upgradeable of other GI functional tests, including Biofeedback, Pudendal Nerve Latency Testing, antro-duodenal manometrySystem must have a computer using Microsoft Windows 7 OSBioVIEW Software for inSIGHT, or equalFor HRiM analysis, bolus transit should be able to be displayed either as a separate image or an overlay with the manometric findingsThe analysis software should include the capability to automatically analyze manometric data using the Chicago Classifications or Conventional Manometric Analysis functionsSoftware must support real-time SyncVIEW using Wire Frame Multi-Dimensional Display Technology capable of showing “virtual esophagus” playback using advanced wire frame multi-dimensional display technology included as an integral element of both the acquisition & analysis softwareThe report should contain a data table including all Chicago Classification analysis metrics, including IRP, DCI, CFV, Distal Latency & Peristatic BreaksThe report should contact a data table including Conventional Manometry findingsThe report should provide LES Profile Data as well as Bolus Transit metrics (Impedance catheter only)The acquisition software should provide the capability of viewing using either HREPT (High Resolution Esophageal Pressure Topography), standard waveforms, SyncVIEW using Wire Frame Multi-Dimensional Display TechnologyAcquisition software should have catheter specific guided protocols to guide the user through the study leading to reduced study complexity & optimized data consistencyAnalysis software should be loadable on an unlimited number of PCs at no additional charge. No user license should be requiredShould provide free software updates for the life of the projectDuring data acquisition, there should be a facility for pausing & restarting the recording, which should be automatically saved on the computerThere should be facility for marking events like the type of swallow, the position of the catheter, respiration, cough/sneeze, catheter pull-through, etc.Operation requirementAmbient temperature: 10 to 40 degrees CAltitude: -400 to 2200 meters MSLPower specs: 100-230V; 50-60HzTrainingProvide access to the following clinical training opportunities:A comprehensive training program in a dedicated classroom environment to practice hands0on exercisesCyber-coaching from a Registered Nurse experienced in motilityOnline training program with downloadable teaching modulesComprehensive warrantyTwo years comprehensive hardware warrantySpare parts & required consumables should be available for a period of at least 7 years from the date of purchaseThe High Resolution Manometry Catheter should have a two-year/200 use warranty including repair of original catheter when warranted claim is validatedThe equipment should follow international standards & safety requirement. Should be UD FDA approvedTechnical supportThe manufacturer should provide 24/7/365 technical supportThe manufacturer should have on-line diagnostic capabilities for the system & software, free of charge to the end userZepHr, or equal, SpecificationZepHr Reflux RecorderA single, portable recording hardware platform that must have the capability for multiple diagnostic testing modules, including:pH monitoringImpedance/pH monitoringAcid (pH) Laryngopharyngeal Reflux (LPR) monitoringImpedance/pH LPR monitoringA single, portable, recording hardware platform capable of supporting multiple catheter technology configurations, including, but not limited to:1 distal esophageal pH channel, internal reference, infused or not infused1 distal esophageal pH channel, internal reference, with impedance, infused or non-infused1 proximal esophageal pH & 1 distal esophageal pH channels, with impedance, infused or non-infused1 distal esophageal pH & 1 1 gastric pH channel, internal reference, with or without impedanceSingle branch LPR catheters with distal & proximal pharyngeal impedance sensors surrounding a pH channel in addition to esophageal impedance & pH channelsPortable recorder must be able to directly interface with a Lower Esophageal Sphincter locator working with disposable Infused pH or Infused Impedance/pH catheters to accurately locate the proximal border of the Lower Esophageal Sphincter (LES) for pH Sensor placementPortable recorder device must have at least 3 programmable buttons for patient-specific symptoms, in addition to dedicated buttons for start/stop meals & dedicated buttons for upright/supine positionsPortable recorder device must operate on 2 AA-cell batteries for at least 24 hoursPortable recorder must interface with catheters, which allow data analysis for reporting gastric acid analysis, distal acid/non-acid analysis & proximal (LPR) acid/non-acid analysisRecorded data should be stored on a SD memory card to allow for rapid “turn-over” between patient studiesThe system should operate on a PC using Microsoft Windows 7 OSBioVIEW Analysis Software, or equalThe analysis software must include the capability to automatically analyze pH & impedance/pH data to identify Reflux Events using advanced neuronet architectureThe analysis software must include the capability to associate Reflux Events with Symptoms automatically, including the Symptom Index & Symptom Association Probability data.The analysis software must allow printed reports in multiple formats, including MS Word & PDF filesReport must contain a data table for Acid, Weakly Acidic, & Non-Acidic Reflux Events, as well as a data table for correlating reflux events with symptomsAcquisition software should have catheter specific guided protocols to guide the user through the study leading to reduced study complexity & optimized data consistencyThe system must have the ability to detect incompatibility between catheter & study protocolThe acquisition software should provide the capability of viewing using either standard waveforms, color contour mapping or Wire Frame Multi-Dimensional Display TechnologySoftware must support real-time SyncVIEW using Wire Frame Multi-Dimensional Display Technology capable of showing “virtual esophagus” playback using advanced wire frame multi-dimensional display technology included as an integral element of the analysis software programRaw data must be loadable on an unlimited number of PCs at no additional charge. No user license should be requiredUpdates to analysis software should be provided free of charge for the life of the productOperation requirement:Ambient temperature: 10 to 40 degrees CAltitude: -400 to 2200 meters MSLPower specs: 100-230V; 50-60HzTrainingProvide access to the following clinical training opportunities:A comprehensive training program in a dedicated classroom environment to practice hands0on exercisesCyber-coaching from a Registered Nurse experienced in motilityOnline training program with downloadable teaching modulesComprehensive warrantyTwo years comprehensive hardware warrantySpare parts & required consumables should be available for a period of at least 7 years from the date of purchaseThe equipment should follow international standards & safety requirement. Should be UD FDA approvedTechnical supportThe manufacturer should provide 24/7/365 technical supportThe manufacturer should have on-line diagnostic capabilities for the system & software, free of charge to the end user ................
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