YY/T 1685-2020 in English

This standard applies to expectoration equipment that generates pulsed airflow through an air pulse generator and transmits it to an inflatable air bag through a air guide hose to act on the chest cavity. It explicitly excludes vibrating percussion expectoration machines and stipulates that the pneumatic pulse oscillation function in multi-function equipment must separately comply with the requirements of this standard.

Safety Warning: When the maximum pneumatic pressure exceeds 6kPa, risk identification must be carried out and preventive measures must be noted in the instructions.

Parts in contact with the human body must be evaluated for biocompatibility according to GB/T 16886.1, and the environmental test must comply with the following:

• Climate environment Group II requirements
• Mechanical environment Group II requirements

Clinical use recommendations:

1. Frequency settings should follow the principle of gradual progression from low to high
2. Strictly distinguish between pediatric and adult airbag sizes
3. Establish a list of contraindications for patients with fractures, pneumothorax, etc.

Maintenance requirements:The airbag cleaning and disinfection methods and replacement cycles must be clearly stated in the instructions

This standard was first published in 2020, filling the gap in the special standard for pneumatic pulsed sputum removal equipment. Compared with traditional vibrating sputum removal equipment, this technology has the advantages of directional oscillation and controllable pressure, and is particularly suitable for postoperative airway management. During the formulation of the standard, GB 9706.1 electrical safety requirements and YY 0505 electromagnetic compatibility standards were mainly referenced.