SAM #36C26326Q0918

Market Research for American-Made Compact Spirometer for VA Central Iowa

This opportunity involves market research by the Department of Veterans Affairs Central Iowa Health Care System for a compact, American-made spirometer system. - Government Buyer: - Department of Veterans Affairs (VA), Network Contracting Office 23, Central Iowa Health Care System - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Products/Services Requested: - One compact, desktop spirometer for pulmonary function testing - Must perform spirometry (FEV, FVC, SVC, MVV), lung volume (TLC, FRC, RV) without plethysmography, and DLCO single-breath diffusing capacity measurements - Flow sensor with 0.18 L/s range and 2.5% accuracy - Multi-gas analyzer (CO/CH or equivalent) - Automated calibration and FDA-cleared bacterial/viral filter - Touchscreen interface (8-12 inch HD) - Data export in standard formats with HL7-compliant interfaces for EHR integration - Accessories: carry case, DLCO gas regulators, HL7 configuration, 3-liter calibration syringe - Certified for inpatient and outpatient hospital use - Compatible with VA-approved disinfectants - Operates on standard hospital AC power - Includes 1-year manufacturer's warranty, technical support, delivery, installation, and on-site operator training - Unique/Notable Requirements: - Device must be manufactured in the United States (Buy American Act applies) - Must be FDA-cleared and compliant with ATS/ERS, IEC 60601, and NFPA 99 standards - Must provide documentation of compliance with all listed standards - Integration with electronic health record systems via HL7 is required

Description

The Central Iowa Health Care System requires the purchase of one spirometer with the salient characteristics listed below.

This is a SOURCES SOUGHT NOTICE only looking for American manufactured equipment as listed below for market research purposes. No proposals are being requested or accepted with this notice. THIS IS NOT A SOLICITATION FOR PROPOSALS OR PRICING AND NO CONTRACT SHALL BE AWARDED FROM THIS NOTICE. This notice shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. The Buy American Act, FAR 52.225-1, applies. Interested vendors shall include the place of manufacture in their responses.
Responses to this notice will be treated only as information for the Government to consider as part of their market research efforts. The information provided will be used by the Government in developing its acquisition strategy regarding possible set aside for Veteran Owned and other socio-economic categories of small business. Interested parties are responsible for adequately marking proprietary, restricted or competition sensitive information contained in their response. The Government does not intend to pay for the information submitted in response to this notice and parties responding will not be entitled to payment for direct or indirect costs incurred in responding to this notice.
The North American Industry Classification System (NAICS) code for this requirement is 339112 Surgical and Medical Instrument Manufacturing with an SBA Small Business Size Standard of 1,000 employees. The deadline for this information is 4:00 PM Central Time on Monday, July 20th 2026. Be a compact, desktop PFT suitable for loading & transportation by PFT Therapist via automobile. Weight range 10 lb. to 25 lb. and measuring between 20 H x 18.5 D x 12 W and 24 H × 20 D × 15 W. Provide spirometry testing (FEV , FVC, SVC, MVV, at a minimum). Provide lung volume measurements (TLC, FRC, RV) without use of plethysmography box. Provide DLCO single-breath diffusing capacity measurements including DLCO, VA, and DLCO/VA. Use a flow sensor with 0 18 L/s range, ±2.5% accuracy or ±0.05 L/s. Include a multi-gas analyzer (CO /CH or equivalent) with response time no greater than 1 minute. Automated calibration/zeroing, warm-up <10 minutes. Calibration done per American Thoracic Society 3 -Liter syringe. Operating temperature range 65 F to 75 F. Use an FDA-cleared bacterial/viral filter with 99.99% cross-contamination prevention. Operate on universal medical-grade power (100 240 VAC, 50 60 Hz). Include a touchscreen interface (screen measuring between 8-12 HD).

Provide data export in standard formats, generate user defined reports, and enable integration with electronic health record systems through HL7 compliant interfaces standard formats, generate user defined reports, and enable integration with electronic health record systems through HL7 compliant interfaces (PDF, CSV, JSON, etc.) Be compliant with ATS/ERS standards for spirometry, lung volumes, and DLCO. Hold applicable FDA clearance for clinical diagnostic use and comply with applicable IEC 60601 and NFPA 99 electrical safety requirements. Required accessories included with the system: Carry Case DLCO Gas Regulators HL7 Configuration (1 device) 3-Liter Calibration Syringe Unit Requirements Certified for inpatient & outpatient hospital use Exterior surfaces compatible with VA-approved hospital-grade disinfectants (e.g., Super Sani-Cloth, PDI bleach wipes, or equivalent) 1 year manufacturer's warranty included in price (parts and labor); warranty period begins on date of Government acceptance Manufacturer technical support (telephone and/or remote diagnostic) included for the full warranty period Operates on standard hospital AC power (100 240 VAC) with a medical-grade power supply Delivery, installation, and on-site operator training by a qualified manufacturer representative or certified technician included in price Operations manuals & IFU Cleaning instruction provided by manufacturer Offerors must provide documentation demonstrating compliance with all listed standards

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