YY 0042-2018High-frequency jet ventilators (English PDF)

1 Scope

This Standard specifies the basic safety, performance, marking and information provided by the manufacturer for high-frequency jet ventilator (hereinafter referred to as ventilator).

This Standard applies to high-frequency jet ventilator with both exhalation and inhalation open.

The device is suitable for use by patients who need respiratory support, respiratory therapy and emergency resuscitation under the supervision of medical staff.

2 Normative References

The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.

GB/T 4999 Anesthetic Equipment and Breathing Machine - Vocabulary

GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety

GB 18278.1 Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

GB 18279.1 Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

GB 18280.1 Sterilization of Health Care Products - Radiation - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

GB 18281.1 (all parts) Sterilization of Health Care Products - Biological Indicators

YY/T 0466.1-2016 Medical Devices - Symbols to be Used with Medical Device Labels, Labelling and Information to be Supplied - Part 1: General Requirements

YY 0600.3-2007 Lung Ventilators for Medical Use - Particular Requirements for Basic Safety and Essential Performance - Part 3: Emergency and Transport Ventilators

YY 0601 Medical Electrical Equipment - Particular Requirements for Basic Safety and normally within the input pressure range of 280kPa~600kPa

4 Gas-Source Supply

It shall not cause any hazard when the pressure of the air inlet is up to 1000kPa. When the gas source pressure is 280kPa, the average gas flow measured at the high-pressure gas input port of the ventilator shall not exceed 60L/min (over 10s time-weighted average).

5 Power Supply

6 Mechanical Strength

The ventilator that can be used for out-of-hospital transport shall be able to withstand the stress caused by rough operation during working; and the ventilator shall continue to work during and after the vibration impact test according to 21.6a), 21.6b) and 21.6aa) of YY 0600.3-2007.

7 Waterproof

The waterproof rating of ventilators that can be used for out-of-hospital transport shall be IPX4.

8 Fireproof

In normal or single fault conditions, combustible materials shall not be in both of the following conditions at the same time:

--- the material temperature reaches the minimum ignition temperature;

--- the presence of oxidizing agents.

9 Cleaning, Disinfection or Sterilization

Accessories and components in the ventilator breathing system that may be contaminated with rebreathing gases shall be removable for cleaning, disinfection, or sterilization.

If the label indicates that the product is sterile, the product should be sterilized by appropriate and effective methods in accordance with the relevant descriptions in GB 18278.1, GB 18279.1,

GB 18280.1 and GB 18281.

Packaging systems without passing through the sterilized equipment shall maintain product cleanliness prior to sterilization, use; and minimize the risk of bacterial contamination. (0.1kPa + 10% of the setting value).

11 Accuracy of Work Data

12 Prevention of Dangerous Outputs

14 Marking

14.4 All components that are sensitive to the direction of airflow, if the operator can disassemble and install them without tools; measures shall be taken to prevent misconnection. If not, the components shall be marked with clear, easy-to-recognize and permanently attached arrow to indicate the airflow direction.

14.5 If the needle advancing method is used to adjust the oxygen concentration, the advancing direction of the needle when the oxygen concentration increases shall be marked.

15 Information Provided by the Manufacturer

The manufacturer shall provide the following information:

a) the manufacturer's address or the name and address of an authorized representative;

b) cleaning, disinfection or sterilization for reuse, and details of any other means of restriction, if applicable;

c) if the ventilator has internal and/or external backup power supply, the manufacturer shall indicate the corresponding parameters in the relevant documents, including at least:

- voltage;

- current;

- amp-hour rating or operating time from a fully charged power supply;

- a method for determining the status of the backup power supply.

d) if the ventilator is supplied by high-pressure gas, the supply pressure and flow range shall be stated;

e) a warning that the ventilator shall not be covered or placed in a location that affects the operation and performance of the ventilator (e.g., the ventilator shall not be placed next to a barrier, which shall prevent the flow of cool air and overheat the equipment), if applicable; […]