Catheter Vacuum Leak Tester
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Web: standard-groups.com
Applications
The catheter vacuum leak tester is a professional device used to detect leaks in medical catheter systems under vacuum conditions. It is mainly used to ensure the sealing and safety of catheters during use and prevent medical accidents caused by leaks. This tester can be widely applied to the leak detection of various medical catheters, such as suction catheters, drainage catheters, anesthesia catheters, endotracheal tubes, etc.
Standards
GB 15812.1 - 2005 :Non - Vascular Intravascular Catheters - Part 1: General Performance Test Methods
GB 8368 :Disposable Infusion Sets
YY 0489 - 2004 :Test Method for Piston Tightness of Disposable Sterile Syringes
Features
1. High-precision measurement: It can quickly and accurately detect the location and size of leaks in the pipeline system, enabling precise measurement of minute pressure changes and flow differences.
2. Safe and reliable: It prevents safety accidents and quality problems caused by leaks, ensuring the safety and stability of the production process.
3. Easy to operate: The operation interface is simple and clear, allowing users to complete the testing process by following the prompts. Some testers also feature user-level access control and a comprehensive password protection scheme to ensure data integrity, standardization, and traceability.
4. Multifunctional: Some advanced testers offer features such as real-time data display, data recording and analysis, test report generation, and multiple testing modes, meeting the needs of different users.
Technical Parameters
| Parameter | Specification |
|---|---|
| Measuring Range | Usually 0 to -90kPa, which can meet the negative-pressure testing requirements of various catheters |
| Accuracy | Generally reaching level 0.1 to ensure the accuracy of test results |
| Vacuum Maintenance Performance | Equipped with an automatic pressure-holding function to ensure the stability of the vacuum during the test |
| Test Time | Setting range: 1 to 9999 seconds; error ≤ ±1 second |
| Power Supply | Usually 220VAC 50Hz or 120VAC 60Hz, adapting to voltage requirements of different regions |
| Net Weight | Approximately 20kg (varies by model) |
Accessoriess
Standard accessories include: specialized connection adapters for different sizes of medical catheters (compatible with various catheter interfaces such as suction tubes and drainage tubes), vacuum-sealed connecting tubing (for connecting the main unit to the vacuum tank), sample fixing clamps (to secure the catheter under test), standard leak calibration components (to ensure the accuracy of the equipment's measurements), operating instructions, and a calibration certificate.
Test Procedures
Open-system catheter: Open the catheter vacuum control device to the release position, turn on the vacuum pump, and adjust the flow rate to the specified value (e.g., 30 L/min).
Closed-system catheter: Remove the pressure gauge, turn on the vacuum control device and vacuum pump, adjust the flow rate to the specified value, then switch the vacuum control device to the closed position, and reattach the pressure gauge. Read and record the residual vacuum value measured on the pressure gauge, which is usually expressed in kPa. For respiratory tract suction catheters, the residual vacuum should not exceed the specified value (e.g., 0.33 kPa or 3.4 cmH₂O).
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