Automatic Catheter Hydraulic Leakage Tester device

Whats/App: +86 156 1874 6768

Web: standard-groups.com

Standards

GB/T 15812.1: Disposable sterile catheters - Part 1: General requirements

Features

1. Large-Sized LCD Touchscreen Display: The instrument is equipped with a large-sized LCD touchscreen display, allowing users to intuitively and conveniently view real-time displays of test curves. In addition, the display screen features multiple shortcut buttons for easy test operation.

2. Dual Positive and Negative Pressure Testing Modes: The instrument utilizes both positive and negative pressure testing modes, comprehensively covering various types of leakage problems. The positive pressure method detects leaks or ruptures by filling the sample with a certain pressure of gas; the negative pressure method detects leaks by vacuuming the sample or sealed container.

3. High-Precision Pressure Sensor: The instrument uses a high-precision pressure sensor, capable of accurately capturing subtle changes in the sample under different pressure conditions, thus ensuring the accuracy and reliability of test results.

4. Diverse Testing Modes: In addition to the two basic testing modes mentioned above, the instrument also provides several independent testing modes, such as burst strength testing, gross leak testing, bottle cap seal testing, etc., to meet the testing needs of users in different scenarios.

5. Intelligent Operation: The instrument adopts an intelligent operation method; users can complete the testing process by simply pressing the corresponding buttons. The instrument also features various intelligent operation modes such as automatic pressure maintenance, automatic bursting, and rapid leak detection, which users can freely select according to their actual needs.

6. Automatic Test Report Printing: To facilitate users in recording and analyzing test results, the instrument has a built-in miniature printer that can automatically print detailed test reports.

7. Automatic Vacuum Maintenance and Back-Flushing Discharge Function: The instrument features automatic vacuum maintenance and automatic back-flushing discharge after testing, making the entire testing process more automated and efficient.

8. Automatic Constant Pressure Gas Supply Function: The instrument has an automatic constant pressure gas supply function, ensuring fully automatic testing under set vacuum conditions, further improving testing efficiency and accuracy.

9. GMP Permission Management Function: The instrument complies with relevant GMP (Good Manufacturing Practice) regulations and has strict permission management functions, ensuring the security and confidentiality of test data.

Technical Parameters

Parameter	Specification
Test Flow	Usually 30L/min, with an error ≤ ±5%; ensures stable and accurate flow during testing
Pressure Range	Generally 0 - 500KPa, with a resolution of 0.01KPa and an error ≤ ±1%; covers the pressure range most catheters withstand in actual use (ensures test comprehensiveness)
Measurement System Holding Time	Usually 1 minute (configurable); maintains a stable measurement environment during testing (improves test accuracy)
Test Duration	Generally 1 second - 99.9 minutes, with an error ≤ ±1 second; allows flexible setting of test time according to actual needs (ensures test adequacy and effectiveness)
Applicable Catheter Types	Applicable to various medical device products: infusion sets, blood transfusion sets, infusion needles, filters, pipelines, catheters, quick-connect fittings, etc. (meets testing needs of different products)

Accessoriess

Main unit, hydraulic tank, miniature printer

Test Procedures

1. Pre-test preparation

Check the equipment power supply and hydraulic system sealing, and prepare the test tubing and adapter fittings;

2. Sample installation

Connect the tubing to the equipment's hydraulic circuit using a special connector, ensuring a sealed connection;

3. Parameter setting

Select the corresponding standard (e.g., GB/T 15812.1) via the touchscreen, and set parameters such as test flow rate, pressure range, and pressure holding time;

4. Start testing

The equipment automatically fills with fluid and pressurizes, maintaining the set parameters and monitoring for leaks;

5. Process monitoring

Observe pressure changes to confirm whether there are any leakage abnormalities;

6. Completion

After the equipment depressurizes, remove the tubing, record the results, and clean the pipeline.

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