Deep Vein Thrombosis (DVT) Prevention and Treatment Product(QJ-B300)

Technical Specifications

1. Screen and Operation

   • 5-inch capacitive touchscreen

   • Based on the T5L1 chip

   • DGUS II operating system

   • Resolution: 480 × 854

   • 16.7 million colors

2. Treatment Modes

   The system provides five treatment modes: Manual Treatment, Gradient Treatment, Standard Treatment, Advanced Treatment, and Customized Treatment, with at least 30 treatment programs available.

   a) Manual Treatment:
   All treatment parameters can be adjusted manually, allowing the user to select appropriate parameters for treatment. The treatment pressure output error shall not exceed ±3 kPa.

   b) Gradient Treatment:
   Only the pressure of the distal chamber needs to be set. The pressure of each subsequent chamber toward the proximal end decreases by 15 mmHg sequentially. The maximum set pressure is 150 mmHg. The treatment pressure decreases by 15 mmHg from the distal chamber to the proximal chamber. The treatment pressure output error shall not exceed ±3 kPa.

   c) Standard Treatment:
   All chambers operate at the same pressure, with different treatment modes available according to different inflation sequences. The treatment pressure output error shall not exceed ±3 kPa.

   d) Advanced Treatment:
   Based on Standard Treatment, this mode provides a function that allows the chamber corresponding to an injured area to remain unpressurized. The treatment pressure output error shall not exceed ±3 kPa.

   e) Customized Treatment:
   Healthcare professionals can create customized treatment programs according to individual patient requirements and can store treatment programs for at least 15 patients. The treatment pressure output error shall not exceed ±3 kPa.

3. Treatment Pressure

   • Adjustable treatment pressure range: 0–300 mmHg

   • Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

4. Operating Time

   • Adjustable treatment time: 0–9999 minutes

5. Dual Treatment Functions

   • The device provides both:

     • Low-pressure gradient compression for antithrombotic applications

     • High-pressure air-wave massage

   • Separate semi-wrap and full-wrap limb pressure cuffs are provided for the corresponding treatment functions.

   • Treatment-site selection is supported, including the function to exclude an injured area or designated treatment area from pressurization.

6. Device Indication Functions

   • During operation, the screen displays treatment time and pressure.

   • The deviation between the displayed pressure and the actual measured pressure shall not exceed ±5 mmHg.

   • Overpressure warning

   • Underpressure warning

   • Fault warning

   • Dynamic treatment-site indication: the treatment site currently being treated flashes on the screen.

7. Overpressure Protection

   • The device incorporates dual overpressure protection through both software and hardware safeguards.

   • In the event of overpressure, the device provides an overpressure warning and automatically releases the air pressure inside the chambers.

   • Under a single-fault condition, the system is designed to release the maximum pressure in the chambers and connecting tubing.

   • The pressure delivered to the limb shall not exceed 120% of the maximum treatment pressure for more than 1 second.

   • Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

8. Function Control

   • The device is equipped with an output stop switch, allowing the treatment procedure to be interrupted at any time.

9. Fault Self-Inspection

   • The device is equipped with a fault self-inspection function.

   • Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

10. Pulse Width and Refill Time

• Adjustable pulse width: 0–20 seconds

• When the pulse width is set to 5 seconds, the error shall not exceed ±5% of the set value.

• Adjustable refill time: 0–120 seconds

• Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

11. Inflation Speed

• 12-level adjustable inflation speed: Levels 1–12

• At Level 12, the maximum inflation speed, the time required to fully inflate a single air chamber in Gradient Treatment mode shall be less than 10 seconds.

• Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

12. Pressure Release Measures

The device provides automatic pressure release under the following conditions:

a) Manual pressure release:
The patient pressure can be manually released under various operating conditions. Disconnecting the ventilation tubing is sufficient to release the pressure.

b) Completion of treatment:
Automatic pressure release occurs when the preset treatment time is reached and the treatment program is completed.

c) Power interruption:
Automatic pressure release occurs in the event of sudden loss of power.

d) Device fault:
Automatic pressure release occurs when a fault is detected and a fault warning is triggered.

e) Temporary treatment interruption:
Automatic pressure release occurs when the treatment program is temporarily interrupted.

In all of the above situations, pressure release shall be completed with a single action. The time required for the patient pressure to decrease from the maximum pressure to 2 kPa shall not exceed 10 seconds.

13. Installation and Mounting

• Suitable for bedside use.

• Can also be placed on a dedicated medical trolley.

14. Pressure Resistance

• The chambers and connecting tubing shall withstand a pressure of 450 mmHg for 1 minute without rupture or permanent (plastic) deformation.

• Connections shall remain secure without loosening or visible deformation.

• The chambers and connecting tubing shall withstand sudden external forces without localized bulging or rupture.

• Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

15. Air Tightness

• The air chambers and connecting tubing shall provide good air tightness.

• When maintained at the device's specified maximum output pressure for 1 minute, the pressure drop of the air chamber shall not exceed 10%.

• Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

16. Connection Identification

• The connecting tubing shall be equipped with a mechanism or identification mark to prevent incorrect connection.

• Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

17. Screen Control Functions

a) Screen Lock Function:
During operation, tapping the lock icon locks the treatment parameters to prevent accidental operation. The parameters can be adjusted after tapping the unlock icon.

b) Screen Brightness and Night Mode:
Screen brightness is adjustable to at least 8 levels, with support for Night Mode.

c) Automatic Screen-Off Function:
The automatic screen-off time can be set from 1 to 60 minutes. When enabled, the screen automatically turns off after the preset time.

Supporting documentation shall be provided in the response documents. Failure to provide such documentation shall be considered a deviation.

18. Electrical Safety and EMC Compliance

• Complies with GB 9706.1-2020, Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance.

• Complies with YY 9706.102-2021, Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.

19. Limb Pressure Cuffs

• A three-chamber split limb pressure cuff is used in Gradient Treatment mode.

• A full-leg limb pressure cuff is used in other treatment modes.

• Both reusable and single-patient-use versions are available as optional configurations.

• The supplied limb pressure cuffs must have a separate medical device registration certificate.

20. Blood Refill Detection Technology

• Equipped with blood refill detection technology.

• Patent certificate documentation shall be provided as supporting evidence.

21. ISO 13485 Certification

• A valid ISO 13485 Quality Management System Certificate shall be provided.

22. Unique Device Identification (UDI)

• Each device is incorporated into the global Unique Device Identification (UDI) system.

• Every device is assigned a unique medical device UDI code.

• The UDI can be parsed through the IDCODE platform to access detailed product information, facilitating product verification and information retrieval.

23. CE Certification

• A valid CE Certificate shall be provided.

24. Supporting Documentation

• The supporting documentation referred to in the response documents consists of the technical requirements specified in the product registration certificate and its attachments.