6515--RFI - Portable Dialysis Reverse Osmosis Systems

es capable of meeting requirements and salient characteristics below to provide the Wilmington VA Medical Center with Portable Reverse Osmosis Systems. WILMGTON VA MEDICAL CENTER SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR PORTABLE REVERSE OSMOSIS SYSTEMS Background Wilmington VAMC requires two brand name or equal to Aqua C 15 Amp, portable reverse osmosis (RO) water purification systems. 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. Project Scope The Department of Veterans Affairs, Wilmington VA Medical Center requests a brand name or equal procurement for the purchase of new Aqua C UNO PORTABLE RO 15-amp water purification system which includes equipment installation and training. This is a brand name or equal for the following: Aqua C 15 Amp portable reverse osmosis (RO) water purification systems with Softener Portable incl. salt tablet kit, AquaCaddy V2 Backflow Prevention/RPZ, AquaCaddy V2 Bolt on HD Connection kit, AquaCaddy V2 Booster Pump, Aqua Caddy - Dual Carbon Block AAMI Water Profile Kit and Aqua C Uno RO Install with Isopure Cart. SPECIFIC TASK: The contractor shall furnish and deliver the following equipment: o Two (2) AquaC 15 Amp Portable Reverse Osmosis Systems (Product No. 24-10VA-1) o Two Softener Portable includes salt tablet kit (Product No. 24-0479-0) o Two AquaCaddy V2 Backflow Prevention/RPZ (Product No. o 24-ACBF-0) o Two AquaCaddy V2 Bolt on HD Connection. Kit (Option) (Product No. 24-ACCK-0) o Two AquaCaddy V2 Booster Pump (Product No.24-ACBP-0) o Two Aqua Caddy - Dual Carbon Block (Product No. 24-AC02-0) o Two AAMI Water Profile Kit (Product No.24-AAMI-0) o Two Aqua C Uno RO Install with Isopure Cart (Product No.111147) The contractor shall provide complete installation of all two (2) AquaC RO units, including accessories, plumbing connections, and system commissioning. The contractor shall provide on-site training for Medical Center clinical dialysis staff and Bio-Med techs in accordance with the following parameters: o Service: AquaC System Training (Product No. 111122) o One (1) follow-up training session is included within the contract price. o 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. o Portable RO must be compatible with Fresenius 2008T BlueStar dialysis machines. Required salient characteristics the unit must meet the following: System Type Portable, single-patient reverse osmosis (RO) water purification system Height 50cm unit only, excluding cart Width 52cm Depth 20cm Weight (Empty) Approximately 35 kg (77.2 lb) Weight (Full) Approximately 37.5 kg (82.7 lb) 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, 15.5 Amp 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 Classification 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; 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; o