YY/T 1685-2020Pneumatic impulse oscillation equipment for sputum excretion (English PDF)

3.1 Pneumatic impulse oscilation equipment for sputum excretion

The pulsed air flow generated by the air pulse airflow generator enters the inflatable airbag through the air guide tube and acts on the chest to assist in expelling the airway. Secretion equipment.

3.2 Inflatable airbag

A component of the device, used to store pulsed airflow and act on the patient's chest, generally inflatable vest and (or) inflatable chest strap.

3.3 Airhose

The hose used to connect the air outlet of the host and the air bag.

3.4 Manualmode

The operating mode of pneumatic frequency, pneumatic pressure and treatment time is set and adjusted by the operator within the allowable setting range of the equipment. The device does not have a storage function.

3.5 Fixedmodel

The manufacturer will fix the output pneumatic frequency and pneumatic pressure in the output mode of the equipment according to a certain time rule before leaving the factory.

3.6 Custommode

The manufacturer allows the operator to set the pneumatic frequency, pneumatic pressure and/or treatment within the allowable setting range of the equipment according to the needs of use.

Treatment time, and store this setting in the device in a self-named way.

4.1 Classification

Divided by the applicable crowd. children type, adult type, mixed type of children and adults. Divided by output mode. manual mode, fixed mode, custom mode.

4.2 Composition

It is generally composed of a host, an inflatable air bag, an air guiding hose, and (or) a handheld controller.

5.1 Pneumatic frequency setting upper limit and output accuracy

5.1.1 Pneumatic frequency setting upper limit. adult type should not exceed 25Hz, and child type should not exceed 15Hz.

5.1.2 Pneumatic frequency output accuracy. the error between the output value and the set value should not exceed ±20% or ±2Hz, whichever is greater.

5.2 Pneumatic pressure safety and effective range and output accuracy

The manufacturer shall specify the adjustment range of pneumatic pressure, and the error between the output value and the set value shall not exceed ±0.2kPa; if the equipment is If the pressure exceeds 6kPa, it should be marked in the corresponding position and the possible risks and preventive measures should be notified in the manual.

5.3 Working noise

When the equipment is working normally, the noise should not exceed 65dB(A).

5.4 Treatment time

The manufacturer should specify the treatment time setting range, the treatment time setting range should not exceed 60min, and the setting error should not exceed ±10%.

5.5 Requirements for inflatable airbags and air hoses

5.5.1 Inflatable airbag specifications

The manufacturer shall specify the size and tolerance of different specifications of inflatable airbags.

5.5.2 Maximum air pressure bearing capacity of inflatable airbag

The inflatable air bag should be able to withstand a pressure twice the maximum pneumatic pressure output of the equipment.

5.5.3 Connection reliability of air hose

The air hose of the equipment should be connected reliably.

5.6 Fixed mode output

If the device has a fixed mode output, the manufacturer shall specify the combination of device output parameters and the law of change, and the output accuracy of each parameter is incorrect The difference should meet the requirements of 5.1, 5.2, and 5.4.

5.7 Device function

5.7.1 The equipment should have a setting indicating device to indicate the working pressure and pneumatic frequency under the current program.

5.7.2 If the device is equipped with a handheld controller, the handheld controller should at least have the function of suspending vibration or stopping the output.

5.7.3 The equipment should have a pressure relief function. After the pressure relief is started, the time for the pressure of the inflatable bag to drop from the maximum pressure to 0.2kPa should not be greater than 10s.

5.7.4 If the device has the function of a custom mode, the parameters of the custom mode should not be changed when the power supply of the device is restored after a short interruption.

5.8 Power adaptability

The power supply of the equipment is within ±10% of the rated voltage, and the output pneumatic frequency and the maximum pneumatic pressure change rate of the equipment should not exceed ±10%.

5.9 Biocompatibility

Parts and accessories that are expected to come into contact with the human body should be evaluated and documented in accordance with the guidelines and principles given in GB/T 16886.1.

5.10 Appearance

5.10.1 The surface of the equipment should be clean and tidy, and the text, symbols and signs should be clear, free of corrosion, peeling of the coating, obvious scratches, damage and deformation, etc. damage.

5.10.2 The equipment fasteners should be connected firmly, and the function switches and output control mechanisms should be installed accurately and adjusted reliably.

5.11 Specification requirements

5.11.1 The instructions should suggest that the operator's pneumatic frequency setting should be gradually increased from low to high, which can be adjusted according to patient tolerance.

5.11.2 The instructions should specify the treatment sites of different inflatable airbags and the suitable population.

5.11.3 The cleaning and disinfection method and service life of the inflatable air bag shall be given in the instruction manual.

5.11.4 The instructions should provide warnings of contraindications for people with fractures, osteoporosis, pneumothorax, breast implants, etc.

5.12 Electrical safety

The electrical safety of the equipment should meet the requirements of GB 9706.1.

5.13 Electromagnetic compatibility

The equipment should meet the requirements of YY 0505.

5.14 Environmental test

The environmental test of the equipment should be carried out in accordance with the requirements of climate environment group II and mechanical environment group II in GB/T 14710.

6.1 Test conditions

6.1.1 Pretreatment

Before the test, the equipment should be parked at the test site without power for at least 24h. Before the actual series of tests, the Requires warm-up and operation of equipment.

6.1.2 Test environment

It shall be specified by the manufacturer itself, if not specified, it shall be carried out in accordance with the requirements of GB 9706.1.

6.2 Pneumatic frequency setting upper limit and output accuracy

In actual operation, check the adjustment range of the pneumatic frequency setting of the equipment, and it should meet the requirements of 5.1.1; use a vibrometer to test and select to cover At least 4 test points of the minimum, middle, maximum, and manufacturer-defined frequency range of the equipment set frequency range, perform the test, and output the actual measured value and The error of the set value should meet the requirements of 5.1.2.

6.3 Safe and effective range of pneumatic pressure and output accuracy

Use a pressure tester to select the minimum, intermediate, and maximum values that cover the set pressure range of the device, turn on the pressure output, and test the device The error of static inflation pressure at the outlet should meet the requirements of 5.2.

6.4 Working noise

The device is not connected to the airbag, and the front, rear, left, and right positions are 1m away from the device, and the noise generated under the maximum pressure and maximum frequency output is measured. The sound should meet the requirements of 5.3.

6.5 Treatment time

Select the middle and maximum set point of the equipment treatment time, and use a universal stopwatch to measure the treatment time, which should meet the requirements of 5.4.

6.6 Inflatable air bag and air guide hose

6.6.1 Inflatable airbag specifications

According to the manufacturer's description or schematic diagram, measuring the size of the inflatable airbag should meet the requirements of 5.5.1.

6.6.2 Maximum air pressure bearing capacity of inflatable airbag

Connect the air guide hose, and inflate the air bag through the hose with gas twice the maximum pneumatic pressure of the equipment. After maintaining for 10 minutes, the air bag is inflated There should be no rupture or permanent deformation, and the air guide hose should not detach; if the inflatable airbag has an overpressure release device, and the release pressure is less than 2 times the equipment The maximum pneumatic pressure value, the test pressure can be reduced to the critical value of the airbag release pressure.

6.6.3 Reliability of air hose connection

Assemble the inflatable airbag according to the connection method of the air guide hose in the manual, apply a force of 20N in the direction of the pipeline connection, keep it for 1min, and guide it.

The air hose should not be separated from the equipment and the inflatable airbag, and should meet the requirements of 5.5.3.

6.7 Fixed output mode

According to the fixed output mode parameters specified by the manufacturer, the output accuracy should meet the requirements of 5.6.

6.8 Device function

Actual operation, to be verified, should meet the requirements of 5.7.

6.9 Power adaptability

Under the test voltage of 10% of the upper limit of the rated voltage and -10% of the lower limit of the rated voltage claimed by the manufacturer, in accordance with the test of 6.2 and 6.3 Method, measuring the aerodynamic vibration frequency and pneumatic pressure, and the error of the vibration frequency and pressure under the rated working voltage should meet the requirements of 5.8.

6.10 Biocompatibility

The biocompatibility test should be performed according to the methods and procedures specified in GB/T 16886.1, and should meet the requirements of 5.9.

6.11 Appearance

Visual observation and hand feel inspection should meet the requirements of 5.10.

6.12 Manual

Check the contents of the manual and should meet the requirements of 5.11.

6.13 Electrical safety

According to the test method specified in GB 9706.1, it should meet the requirements of 5.12.

6.14 Electromagnetic compatibility

According to the test method of YY 0505, it should meet the requirements of 5.13.

6.15 Environmental test

According to the methods and procedures specified in GB/T 14710, it should meet the requirements of 5.14.