| Item | Specification Description |
|---|---|
|
Product Name |
Water making equipment for hemodialysis |
|
System Water Production Capacity |
≥2500L/H (at 25℃), suitable for ≤50 dialysis beds |
|
Microorganism Content |
Bacteria ≤100 CFU/mL, Endotoxin ≤0.25 EU/mL |
|
System Recovery Rate |
50-75% (adjustable) |
|
Product Process |
Raw water multi-stage treatment → Intelligent two-stage reverse osmosis → Dialysis pipeline thermal disinfection → Dead-leg-free circulating direct supply |
|
Disinfection Method |
Chemical disinfection, thermal disinfection |
|
Equipment Power |
Main unit 11KW±10%, Thermal disinfection device 18KW±10% |
|
Operation Method |
PLC + Intelligent display screen |
|
Operation Mode |
Automatic operation, Manual operation |
|
Operating Weight |
Approximately 2080Kg (including filter), Thermal disinfection device approximately 150Kg |
|
Working Power Supply |
AC380V±10% three-phase five-wire system, Frequency: 50-60HZ |
|
Site Requirements |
Room area ≥18M², Floor with waterproof treatment, Equipped with drainage pipe network |
|
Working Environment |
Room temperature 5~40℃, Relative humidity ≤80%RH |
|
Raw water requirements |
Flow rate ≥8T/H, pressure 0.2~0.45Mpa, water temperature 5-40℃ |
|
Working Pressure |
1.0–1.5 MPa |
|
Structural Material |
304/316L stainless steel pipeline, FRP (Fiberglass Reinforced Plastic) storage tank, Medical-grade connector |
|
1. Product Water Quality Standards |
|
1.1 YY0572-2015 "Water for Hemodialysis and Related Therapies" |
|
1.2 American AAMI and ASAIO Water Quality Standards for Hemodialysis |
|
2. Electrical Safety Standards |
|
2.1 GB 9706.1-2020 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance |
|
2.2 GB 9706.102—2021 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests |
|
3. Product Quality Standards |
|
3.1 YY/T 0793.1-2022 Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies - Part 1: Water Treatment Equipment for Hemodialysis and Related Therapies |
|
3.2 GB/T17219-1998 Safety Evaluation Standard for Drinking Water Distribution Equipment and Protective Materials |
|
3.3 YY/T0316-2008 Application of Risk Management to Medical Devices |