YY 0950-2015Extracorporeal pressure wave therapy devices by compressed air (English PDF)

3.1 Extracorporeal pressure wave therapy devices by compressed air

The extracorporeal pressure wave therapy devices by compressed air refer to the therapy devices that use the projectiles in the energy-driven therapy handles generated by compressed air to conduct impulse-type impact to the therapy heads, and use the pressure waves generated by the elastic collision between projectiles and therapy heads to act on the locations of pain by means of percutaneous conduction.

3.2 Control handle

The operators hold the devices in hands to control the pressure waves generated by the collision between projectiles and therapy heads driven by compressed air.

5.1 Operating conditions

The operating conditions shall conform to the provisions formulated by manufacturers. If not specified, the operating conditions shall meet the requirements specified in the Chapter 10 of GB 9706.1-2007.

5.4 Energy density

The manufacturers shall declare the maximum energy density of each therapy head in the accompanying files. The error shall not be greater than ±20%.

5.5 Depth of penetration

The manufacturers shall declare the maximum depth of penetration of devices in the accompanying files. The error shall not be greater than ±20%.

5.6 Collision frequency

The collision frequency of projectiles and therapy heads shall be adjustable. The error of the collision frequency shall not exceed ±10%.

5.7 Timer or counter

The devices shall have at leave one of the following functions for single therapy counting.

5.8 Pulse width

The manufacturers shall declare the pulse width of output pressure waves in the accompanying files. The error shall not be greater than ±10%.

5.11 Fatigue performance of therapy heads

The manufacturers shall declare the life cycle of devices (calculated by number of times) in the accompanying files. Furthermore, the output energy density of devices throughout the entire cycle shall meet the requirements specified in the Article 5.4.

5.12 Corrosion resistance

The outer surfaces of therapy heads shall have good corrosion resistance. After being conducted with the corrosion resistance test, the therapy heads shall have no corrosion marks, or shall only have slight marks that can be removed after wiping and simple cleaning.

5.14 Functions

5.14.1 The devices shall have the function of displaying, setting or adjusting the operating pressure, collision frequency, time of therapy, or number of collisions.

5.14.2 The devices shall have the function of prompting the insufficient air pressure.

5.14.3 Besides the counting function required in the Article 5.7, each device shall also have a separate counter (or counting function) to record the total number of collisions of projectiles and therapy heads. Furthermore, the above-mentioned counters can only be reset by manufacturers.

5.15 Appearance

The appearance of devices shall be clean and without any mechanical damages, scratches or other defects. The marks shall be clear and distinct. The operating and regulating mechanisms shall be flexible and reliable. The fasteners shall be tight

5.16 Safety requirements

The safety requirements of devices shall meet the requirements specified in GB 9706.1-2007.

6.1 Test devices

The following devices or the test devices whose accuracies are higher than those of the following devices are recommended to be used during the tests.

6.2 Operating pressure

CONNECT the pressure gauge to the input end of compressed air on the control handle in series.

6.3 Energy stability

MEASURE the output energy of devices by converting the energy of output pressure waves into gravitational potential energy. Closely CONNECT the therapy head with the device shown in Figure 1.The mass block shall be completely in contact with the probe.

6.8 Pulse width

The duration of pulse width refers to the corresponding time interval value at 50% of the pulse peak read from the pressure waves displaying on the oscilloscope during the test described in the Article 6.5. The results shall meet the requirements specified in the Article 5.8.

6.13 Biocompatibility

6.13.1 USE the therapy heads made of the proven materials conforming to the biocompatibility. The manufacturers shall declare the materials of therapy heads and the material standards used as basis, and provide relevant evidences as well. The material composition can be verified if necessary.

6.15 Appearance

The verification shall be performed by visual inspection and actual operation.

The results shall meet the requirements specified in the Article 5.15.

6.16 Safety requirements

The test shall be conducted according to the methods specified in the GB 9706.1-2007.

7.1 Inspection category

The quality inspection of devices is divided into exit-factory inspection and type inspection.

7.2 Exit-factory inspection

The quality inspection department of the manufacturer shall inspect devices one by one before they leave the factory.

7.2.2 Determination of exit-factory inspection. The exit-factory inspection can only be determined as qualified after all the inspection items are qualified. Otherwise, the exit-factory inspection will be determined as unqualified.

7.3 Type inspection

7.3.1 The type inspection shall be conducted in the case of one of the following conditions.

7.3.2 The samples for type inspection shall be taken from the qualified exit-factory products. SEE Table 1 for the inspection items.

8.1 Marks

8.1.1 Nameplate

The nameplates shall be installed on the proper locations of devices. The nameplates shall include the following contents at least.

8.1.3 Qualification certificate of product inspection

The qualification certificate of product inspection shall include the following contents at least.

8.1.4 Labels, marks, and the symbols providing information

They shall meet the requirements specified in the YY/T 0466.1-2009.

8.2 Instructions for use

The instructions for use shall include the following contents at least.

9.1 Packaging

9.1.3 Solidly FIX the devices in the boxes to prevent the looseness and scratches during the transportation.

9.1.4 The nude packing of devices shall be performed according to the provisions specified in the purchase contact. It is necessary to take protective measures for nude packing during the transportation. The specific requirements shall conform to the provisions specified in the purchase contact.

9.1.5 The devices shall have the following accompanying files.

9.2 Transportation

The transportation shall conform to the provisions specified in the purchase contact.

9.3 Storage

The devices shall be stored in the well-ventilated rooms without any corrosive gases at -40°C~55°C. The relative humidity shall not be greater than 90%. […]