1. Scope of application: for medical units to disinfect the internal circuit of anesthesia machine ventilator.
2. Disinfection method: ozone, atomization device (compound alcohol or hydrogen peroxide can be selected and the corresponding qualification certificate can be provided).
3. Human-computer dialogue mode: ≥7-inch embedded color touch screen, screen protection (180-degree peel strength: 240-260gf; temperature resistance: 150-180℃ instantaneous; adhesion: 8-12G).
IV. Working mode:
4.1. Only two disinfection modes are displayed on the same screen, simplifying the complex and getting it done with one touch;
4.2. A fully automatic disinfection mode (you can enter the quick start to disinfect the anesthesia machine or ventilator with one click in the fully automatic disinfection mode);
4.2.1. Fully automatic disinfection mode: 15min atomization, 60min disinfection, 30min purification;
4.3. A custom disinfection mode (you can disinfect the anesthesia machine or ventilator after manual adjustment in the custom disinfection mode);
4.3.1. Custom disinfection mode: (20~240)min adjustable, step value 5min.
V. Authoritativeness of disinfection level: The supporting disinfectant and products used in this product must be sent to the manufacturer of this product for inspection, and unified supporting experiments and authoritative testing and filing must be carried out. It can kill the 6th generation of Bacillus subtilis black variant spores with an average killing logarithm value of ≥3.0, which meets the requirements of the Ministry of Health's "Disinfection Technical Specifications" for high-level disinfection of disinfection equipment, and provide relevant qualification certificates.
VI. Disinfection effect: The average killing logarithm of Escherichia coli for 5 generations is ＞5.39, the average killing logarithm of Staphylococcus aureus for 5 generations is ＞5.78, the average killing logarithm of Pseudomonas aeruginosa for 5 generations is ＞5.45, the average killing logarithm of Aspergillus niger for 6 generations is ＞5.51, the average killing logarithm of Staphylococcus aureus for 6 generations is ＞5.70, the average killing logarithm of Bacillus subtilis black variant spores for 6 generations is ＞5.78, the average killing logarithm of Mycobacterium chelonae abscessus subspecies for 5 generations is ＞5.86, the average killing logarithm of Candida albicans for 5 generations is ＞5.61, the average inactivation logarithm of poliovirus type I vaccine strain is ＞4.00, and the average inactivation logarithm of human coronavirus 229E is ＞4.40. All of the above meet the evaluation requirements of the "Technical Specifications for Disinfection" and relevant inspection reports can be provided.
VII. Relative humidity: The relative humidity at the disinfection load is ≥70%.
8. Harmless detection of disinfected equipment:
8.1. Gas flow rate of atomizer: (5~12) L/min;
8.2. Working pressure range of atomizer: (150~350) KPa;
8.3. Gas supply purification device: filter membrane pore size of disinfection gas supply end filter device: ≤0.1µm;
8.4. Non-corrosive detection: Disinfection is non-corrosive, and a non-corrosive test report can be provided.
9. Non-toxic detection to human body: Disinfection is non-toxic to human body, and a test report can be provided.
10. Disinfection stability detection and monitoring:
10.1. Gas transmission speed: (6.5±1.5) L/min;
10.2. Exhaust speed: (5±2) L/min;
10.3. Input ozone concentration: ≥100mg/m³;
10.4. Atomization volume: (0.1～0.4)mL/min;
10.5. Atomization rate: (0.1～0.4)mL/min;
10.6. Time accuracy detection: The accuracy of the set working time and the actual running time is within the range of ±1min;
10.7. Disinfection gas self-check and alarm: Automatic alarm when invalid disinfection or abnormal monitoring disinfection data. During the disinfection process, the concentration of disinfection gas generated inside the disinfection machine is dynamically and real-time monitored, and the concentration change value is displayed on the same screen, and the ozone concentration is within the range of ±10% of the indicated value;
10.8. Automatic temperature monitoring and alarm: Built-in temperature monitoring device, dynamic and real-time monitoring of the temperature of the core parts, and the temperature change value is displayed on the same screen to ensure that the internal temperature of the machine is ≤50℃ (accurate value within ±3℃ range), and the data is automatically alarmed to avoid the impact of high temperature on the product disinfection effect and use safety.
XI. Harmless to human body detection:
11.1. Ozone emission concentration: ≤0.16mg/m³ (better than national standards);
11.2. Ozone residual: ≤0.16mg/m³ (better than national standards);
11.3. Leakage: ≤0.16mg/m³ (better than national standards);
11.4. The concentration of nitrogen oxides produced by the equipment is not more than 2.5% of the concentration of disinfection gas (better than national standards);
11.5. Air filtration device (gas emission): It must adopt the relevant technology or patents of the breathing tube for anesthesia machine and ventilator, which can be reused, can automatically recycle, purify (dry), and decompose the residual disinfection factors to ensure that the internal circuit is fully purified (dried), green emission, and human-machine coexistence.
XII. Injection method: automatic injection, manual injection (manual injection is recommended, following the principle of "ready to use, one injection and one disinfection").
13. Liquid injection volume: In the fully automatic disinfection mode, ≤2mL of disinfectant is injected each time. While achieving a high level of disinfection effect, the energy consumption is lower and the amount of liquid medicine is saved.
14. Single-channel disinfection: Single-channel single-cycle dynamic disinfection can be used to perform closed-loop disinfection inside the anesthesia machine or ventilator circuit.
15. Pathway cabin: The equipment accessories that need to be disinfected can be implanted in it for cyclic disinfection.
15.1. Quantity: one path cabin;
15.2. Sealing method: mechanical knob-type expansion seal;
15.3. Switch mark: available;
15.4. Warning mark: available;
15.5. Instructions for use: registered and filed.
16. The product structure comes with four sets of embedded dust-proof arm vertebrae design to avoid secondary contamination caused by exposed pipes or interfaces.
17. The machine must have an independent track pull-out storage space to facilitate the storage of disinfectants and random accessories to avoid confusion or loss of items.
18. This series of products has NMPA certification, disinfection product manufacturer health license, disinfection product health safety evaluation report, EU CE certification, anesthesia breathing circuit disinfection machine R&D technology operation and maintenance system software copyright registration certificate, and patent certificate.
19. You can choose to add (non-standard) hydrogen peroxide compound factor disinfection machine of the same brand to achieve internal and external disinfection.
19.1. Scope of application: Applicable to the disinfection of air and surface of objects in the space;
19.2. Disinfection method: Five composite factors combined disinfection;
19.3. Disinfection factors: Hydrogen peroxide, ozone, ultraviolet lamp, photocatalyst and high-efficiency filtration components;
19.4. Disinfection level: Meet the high-level disinfection requirements of the Ministry of Health for disinfection equipment, and can quickly eliminate drug-resistant bacteria;
19.5. Human-computer dialogue mode: ≥7-inch color touch screen, screen protection (180-degree peel strength: 240-260gf; temperature resistance: 150-180℃ instantaneous; adhesion: 8-12G);
19.6. According to the needs of different scenarios, active disinfection (human-machine separation) and passive disinfection (human-machine coexistence) can be realized.
