Provide medical equipment

LOW-TEMPERATURE PLASMA DECONTAMINATION DEVICE

1

Female

I. General Requirements - Manufacturing Year: 2025 and later, 100% new - International Quality Standards: ISO 9001, ISO 13485, ISO 14001, CE (EU) 2017/745 Medical Device Regulation or equivalent - Power Supply: AC 380V - 50Hz - Equipment Operating Conditions: + Ambient Temperature: 10ºC - 40ºC + Maximum Humidity: 75% - Main Machine Origin: Group of G20 Countries II. Equipment Configuration: Main Machine: 1 unit Standard accessories include: Integrated thermal printer: 1 piece Integrated vacuum pump inside the machine: 1 piece Steam, Plasma, EO sterilization technology ≥3: 1 piece 30-minute rapid biological indicator reading: 50 pieces Plasma chemical indicator: 250 tests Stainless steel instrument tray: 2 pieces Thermal paper: 1 roll Hydrogen Peroxide disinfectant: 5 cassettes Standard accessories (H2O2 filter core, vacuum pump oil, funnel): 1 set User manual: 1 set III. Technical Requirements Capacity: 135 liters Effective capacity: 110 liters Overall dimensions (LxWxH)mm: 1030x760x1760 Weight (Kg): 400 Power Supply: 380V 50Hz Power: 3.8 KW Sterilization Chamber Chamber size (LxWxH)mm: 750x450x400 Rectangular chamber, aluminum alloy material, 8mm thick, good heat conduction, ensures 100% hydrogen peroxide in gaseous form. Aluminum alloy electrodes, sheet type, thickness ≥ 2mm. Chamber insulation with silicone and flame-retardant fiber, low thermal conductivity, good fire resistance, easy to maintain and remove, strong aging resistance, non-toxic and environmentally friendly Sterilization chamber heating power: 1200W Heating time ≤ 30 minutes Door: 1 door, automatic sliding door The door is made of high-quality aluminum alloy, thickness ≥ 20mm. There are 2 separate heaters for the sterilization chamber door to prevent hydrogen peroxide gas condensation, affecting the sterilization efficiency Door temperature: 50±2°C Temperature control sensor for the door: 1 per door, high accuracy temperature sensor, resolution ≤ 0.1°C, accurately detects and controls the disinfection temperature. Pressure converter: 3 sets to control the entire device There is a door opening switch on the touch screen and a button. It has a function to prevent the door from closing, avoiding hand and instrument clamping, sterilization. Vacuum pump: Deep vacuum, limit ≤ 50 Pa and corrosion resistance to H2O2. The vacuum pump has a phase change protection mechanism to prevent reverse operation due to changes in power supply phase. Plasma Power: 380~550W Vacuum pump power: 0.75kW HEPA H13 filter, size ≤ 0.2μm, efficiency 99.97% After sterilization, the remaining H2O2 in PTFE tube <0.003mg/cm2, the remaining amount in stainless steel tube <0.01mg/cm2 Display and control: Touch screen color 5.7'' display temperature, pressure, time, cycle, status, chemical usage quantity, warning information Control system: Siemens S7-1200 PLC Integrated biological indicator steaming unit Integrated thermal printer for printing cycle information Real-time power monitoring and recording, automatically detects and handles abnormal power failures. Sterilization program There are 3 sterilization programs: standard, rapid, flexible. It can sterilize instruments with tubes: + Teflon or polyethylene tube diameter ≥ 1mm, length ≤ 2000mm + Stainless steel tube: diameter ≥ 1mm, length ≤ 500mm Sterilization temperature: 50℃±5℃ Disinfectant cassette Hydrogen Peroxide solution 56-60% in cassette (12 tubes * 5ml/cassette) RFID chemical recognition There is a 1-cycle standard sterilization time: 55 minutes (Standard cycle for instruments with and without tubes); RAPID: 26 minutes (Rapid cycle) FLEXIBLE: 45 minutes (Flexible cycle for two soft tube instruments with diameter ≥ 1mm, length ≤ 1000mm) H2O2 consumption: 2 tubes per cycle Standard, Flexible 1 tube per cycle Rapid Information Smart reminder for intelligent maintenance of key components, real-time monitoring of physical parameters (chamber pressure, temperature, plasma power and sterilization time), touch screen displays data and prints with thermal printer. Automatic biological indicator steaming and reading unit Used to steam and read biological indicators for 4 types of sterilization: steam, EO, Plasma VH2O2, Formaldehyde Temperature steaming: 37ºC and 60ºC Steaming and result time: Steam: 20 minutes; VH2O2: 30 minutes; Formaldehyde: 2h; EO: 4h Integrated thermal printer, USB connection for data storage and traceability Meets FDA standards US FDA Biological indicator reading in 30 minutes for Plasma sterilization - Each tube contains ≥ 10^6 Geobacillus stearothermophilus spores - Steaming temperature: 60 degrees C - Results in 30 minutes. - Complies with standards: ISO 13485; FDA; ISO 11138-1:2017; IRAM 37102-1:1999 Plasma chemical indicator - Test conditions: 50 degrees C, for 6 minutes with H2O2 concentration: 2.3 mg/L - Color change: Red to yellow - Complies with standards: ISO: 13485: 2016; ISO 11140-1:2014; FDA IV. WARRANTY – MAINTENANCE >= 12 months from the date of equipment handover

Da Nang Orthopedic and Rehabilitation Hospital

- The specifications in this Appendix are minimum requirements, intended only for description and not to restrict suppliers' bids. Any brand names or codes (if applicable) in the detailed technical specifications are used solely to illustrate quality standards and technical features. Therefore, suppliers can offer products with equivalent or superior specifications and features. - Units are encouraged to contact the Organization – Administration – Management department for guidance and preliminary assessment before submitting bids.