Portable Reverse Osmosis Water Purification System

a sole source contract to Fresenius USA Marketing, Inc. via SAC mandatory national contract no. 36C10G22D0012. SOL: 36C24226Q0751 DUE: 07/03/2026 SET ASIDE: N/A NAICS: 334516 POP STATE: 30 Days ARO AGENCY: Department of Veterans Affairs; VA Healthcare System, 130 West Kingsbridge Road, Bronx, NY 10468. Email: [email protected] The Department of Veterans Affairs, Margaret Cochran Corbin VA Campus, intends to award a one-time firm fixed-price, sole source contract to Fresenius USA Marketing, Inc. the authority of Federal Acquisition Regulation (FAR) 13.106-1(b) (1)(ii) to Fresenius USA Marketing, Inc. located at 920 Winter Street Waltham, MA 02451 for their Portable Reverse Osmosis Water Purification System.

Background This Statement of Work (SOW) establishes the

requirements for the one-time procurement of four (4) brand name only AquaC 20 Amp portable reverse osmosis (RO) water purification systems with AAMI Water Profile Kit. The systems are required to support hemodialysis operations and to ensure a safe, AAMI-compliant water supply for patient care. The current portables require immediate replacement due to frequent, high-level bacterial contamination. Despite rigorous, in-depth disinfection and ongoing maintenance, the units advanced age and deterioration prevent effective sanitization. Scope Purchase of AquaC UNO RO 20 amp water purification system which includes equipment installation and training Specific Tasks The contractor shall furnish and deliver the following equipment: Four (4) AquaC 20 Amp Portable Reverse Osmosis Systems (Product No. 24-0970-1) Four (4) AAMI Water Profile Kits (Product No. 24-AAMI-0) The contractor shall provide complete installation of all four (4) AquaC RO units, including mounting on existing Marcor carts, plumbing connections, and system commissioning. The contractor shall provide on-site or training-center technical training for Medical Center clinical staff in accordance with the following parameters: Service: AquaC System Tech Training at Training Center (Product No.

111122) Initial training shall consist of a minimum of twenty-four (24) hours, not to exceed forty (40) hours, for up to five (5) healthcare professionals. One (1) follow-up training session is included within the contract price. Training must be initiated within thirty (30) calendar days after system installation; the follow-up training must be initiated within ninety (90) calendar days after installation. Failure to initiate within these windows shall result in expiration of included training, and additional fees will apply. Additional attendees beyond five (5) and any additional training beyond initial plus one follow-up session are not included in this SOW and will incur additional charges. AquaC Salient Characteristics: System Type Portable, single-patient reverse osmosis (RO) water purification system Configuration Modular cart-mounted unit; compact design for bedside/in-unit placement Height 500 mm (1.64 ft) unit only, excluding cart Width 520 mm (1.71 ft) Depth 195 mm (0.64 ft) Weight (Empty) Approximately 35 kg (77.2 lb) Weight (Full) Approximately 37.5 kg (82.7 lb) Cart Compatibility Must be compatible with Marcor cart platform; designed for mounting on AquaC Cart US option Portability Must be cart-mounted and portable within the clinical environment; no permanent plumbing required Water Quality Standard Must meet or exceed ANSI/AAMI RD52 hemodialysis water quality standards for bacteria, endotoxins, and chemical contaminants Permeate Output Minimum 85 L/h (±10%) at 15°C (59°F) water inlet temperature Bacterial / Endotoxin Rejection Greater than 99% rejection rate for bacteria and endotoxins Dissolved Salt Rejection Greater than 96% average rejection rate for dissolved salts Membrane Type Spirally-wound RO membrane Yield (Low Hardness) Up to 70% at feed water hardness <1 °dH (<17.8 ppm CaCO3) Yield (Higher Hardness) Up to 60% at feed water hardness >1 °dH (>17.8 ppm CaCO3) Concentrate Pressure (Max) Maximum 290.1 psi Noise Level (SUPPLY mode) 44 46 dB(A) measured at 1 meter distance Permeate Output (Disinfection) 12 L/h (±10%) during ring heat disinfection cycle Bacterial / Endotoxin Rejection Greater than 99% rejection rate for bacteria and endotoxins Dissolved Salt Rejection Greater than 96% average rejection rate for dissolved salts Membrane Type Spirally-wound RO membrane Yield (Low Hardness) Up to 70% at feed water hardness <1 °dH (<17.8 ppm CaCO3) Yield (Higher Hardness) Up to 60% at feed water hardness >1 °dH (>17.8 ppm CaCO3) Concentrate Pressure (Max) Maximum 290.1 psi Noise Level (SUPPLY mode) 44 46 dB(A) measured at 1 meter distance Permeate Output (Disinfection) 12 L/h (±10%) during ring heat disinfection cycle Bacterial / Endotoxin Rejection Greater than 99% rejection rate for bacteria and endotoxins Dissolved Salt Rejection Greater than 96% average rejection rate for dissolved salts Membrane Type Spirally-wound RO membrane Yield (Low Hardness) Up to 70% at feed water hardness <1 °dH (<17.8 ppm CaCO3) Yield (Higher Hardness) Up to 60% at feed water hardness >1 °dH (>17.8 ppm CaCO3) Concentrate Pressure (Max) Maximum 290.1 psi Noise Level (SUPPLY mode) 44 46 dB(A) measured at 1 meter distance Permeate Output (Disinfection) 12 L/h (±10%) during ring heat disinfection cycle Electrical Supply 120 V AC, 60 Hz, 20 Amp dedicated circuit Nominal Power Variants 120 V 1000 VA or 120 V 1700 VA (per voltage variant) Operating Mode Continuous operation (Standby); SUPPLY mode used periodically during treatment Electrical Safety Classified per EN 60601-1:2006 + A1:2013 / IEC 60601-1:2005 + A1:2012 Grounding Requirement Must be connected to supply network with protective conductor (grounded outlet); no ungrounded connections permitted Fuse Protection Internal fuses for voltage component protection; replaceable only by trained/certified personnel EMC Compliance Compliant with applicable electromagnetic compatibility (EMC) standards; no stacked installation with other electrical devices Interface / Connectivity Fresenius hemodialysis device interface port; LAN port (RJ-45); compatible with Fresenius 2008T BlueStar dialysis machines Thermal Disinfection Module Module heat disinfection up to 82°C (179.6°F) Thermal Disinfection Ring Ring heat disinfection up to 90°C (194°F) Membrane Service Life Minimum expected life of 120 heat disinfection cycles Chemical Disinfection Compatible with peracetic acid solution (~0.2% effective concentration); system volume 2.5 L (0.66 gal) Decalcification Compatible with approximately 20% citric acid solution; automated decalcification program required Rinse Interval Automated rinse cycle: minimum every 4 hours; rinse volume 10 L (3 gal) or 10-minute rinse time AutoSTART / AutoSTOP System shall support automatic start in SUPPLY mode via communication cable connection to dialysis machine Disinfection Validation System must provide auditable disinfection reporting and daily operational data acquisition logs Biocompatibility Standard All components in contact with permeate must be biocompatible per DIN EN ISO 10993-1 Tubing / Piping Material FEP, silicone, or stainless steel; food-grade with chemical resistance Sensors Titanium (Ti), Aluminum Oxide (Al O ), PBT Module Tube V4A stainless steel Membrane Material PSU/PA (polysulfone/polyamide) Hydraulic Blocks / Valves iPP, PVDF, Noryl GTX Seals EPDM (ethylene propylene diene monomer) Sampling Ports Integrated permeate sampling ports for microbiological and chemical analysis Permeate Connection Permeate nipple; optional permeate coupling; compatible with Fresenius hemodialysis machine water inlet Feed / Concentrate Flow Feed flow: 0.0 20 L/min (±10%); Concentrate flow: 0.0 20 L/min (±10%) Permeate Consumption 0 6 L/min (±10%) during normal supply operation Drain Connection System drain must connect to available outlet; no recontamination of permeate circuit permitted Water Supply Hose Must connect to potable water supply meeting pre-treatment feed water

requirements Installation Type Portable; no permanent wall or floor mounting required; Marcor cart-based Stacking / Adjacency System must NOT be stacked with other electrical devices; minimum separation distances from radiation sources required per IFU Operational Qualification Vendor must perform Installation and Operational Qualification (IQ/OQ) at time of installation Display Integrated digital display with operating mode status bar; multilingual support Permeate Conductivity Monitoring Continuous real-time permeate conductivity measurement and display; alarm on out-of-range condition Feed Water Conductivity Continuous real-time feed water conductivity measurement and display Temperature Monitoring Permeate and concentrate temperature display; heater temperature 1.0 135°C (±1°C); concentrate temperature 1.0 135°C (±1°C) Rejection Rate Display Real-time rejection rate display: 0.0 99% (±1%) Effective Yield Display Effective yield display: 0.0 70% (±5%) Alarm System Audible and visual alarms for: no water supply, fault drain, conductivity fault, sensor error, and other abnormal conditions; alarm must halt dialysis supply automatically Operational Data Logging System must support manual and automated daily operational data acquisition and reporting per AAMI

requirements Visual Status Indicator Green visual indicator must illuminate to confirm system is ready for treatment