Guidewires Tip Flexibility Tester

The Guidewires Tip Flexibility Tester is designed and manufactured in accordance with the relevant clauses of YY/T 1554-2017 and YY 0450.1-2003. It is specifically designed for testing the flexibility of interventional guidewires and catheters, and is suitable for determining the tip flexibility of various interventional guidewires and catheters.

Applications

The guidewire tip flexibility tester is a specialized device used to evaluate the flexibility of the tips of medical guidewires. Its main uses include: Ensuring Quality and Safety in Clinical Use: By testing the flexibility and bendability of the guidewire tip during puncture procedures, it ensures that the guidewire can smoothly enter blood vessels or other target positions and adapt to different puncture angles and bending situations, thus improving the effectiveness and safety of puncture operations. Assisting Manufacturers in Quality Control: In the medical device manufacturing field, this tester can be used by manufacturers for quality control of guidewire products, ensuring that guidewire products meet relevant medical standards and regulatory requirements. Biomedical Research and Bioengineering Applications: The tester can also be used to measure the flexibility and bendability of various biological materials, evaluate the toughness of biological stents and biological materials, and provide technical support for biomedical research and the bioengineering field.

Standards

FDA-16007 FDA Guidance: Coronary, Peripheral, and Neurovascular Guidewires –Performance Tests and Recommended Labeling

ISO 11070:Cardiovascular implants and extracorporeal systems — Balloon dilatation catheters

YY 0450.1-2003:Disposable sterile intravascular catheters — Part 1: General requirements

YY/T 1554-2017:Medical devices — Surface lubricious coatings — Test method for coefficient of friction

Features

1. Intelligent Operation: A large LCD screen displays the testing process in real time. Built-in standard testing programs enable one-click operation and automatic completion of the experiment.

2. High-Precision Sensors: Utilizes advanced displacement sensors to ensure accurate speed and displacement transmission, making testing more scientific and reliable.

3. Secure and Compliant Design: Supports hierarchical access control and password protection to prevent unauthorized operations and ensure data traceability.

4. Complete Data Output: Equipped with a mini printer, it can directly print information on test personnel, testing time, and results, ensuring complete retention of experimental records.

5. Personalized Upgrades: The system program supports ISP online upgrades and can provide customized services based on user needs.

Technical Parameters

Technical Parameter	Specification
Testing Speed	It can be adjusted within a certain range, such as 3mm/min or 8mm/min. Some testers can reach 100mm/s and can be set arbitrarily with stepless speed regulation, and the speed accuracy can reach 0.01mm/s.
Displacement Range and Resolution	The displacement range is generally 0.001 - 40.000mm, and the displacement resolution is 0.001mm.
Force - measuring Mechanism	Mostly built - in, using high - precision force sensors.
Control System	Commonly, there is a PLC (Programmable Logic Controller). The operation interface is generally a color touch screen, which can be switched between Chinese and English.
Clamping Device	It is used to fix the guidewire tip to ensure the stable position of the guidewire during the testing process. It is generally made of high - quality materials such as 304 stainless steel.

Accessoriess

The package includes: 1 main unit, 1 set of fixtures, 1 set of testing software, 1 set of sensors, 1 power cord, 1 instruction manual, 1 operation video, and 1 certificate of conformity.

Test Procedures

1.Device Preparation

Check the instrument’s power supply, connection status, and external components (e.g., clamps, sensors) for integrity.

Power on the device and preheat it to the required working state (if specified by the instrument).

2.Sample Preparation

Take the guidewire to be tested, confirm its model/specification meets the test requirements, and clean the guidewire surface (to avoid contamination affecting test results).

3.Sample Installation

Fix the guidewire on the instrument’s clamping device (use 304 stainless steel clamps as mentioned), and accurately position the tip part of the guidewire at the test station (ensure stable fixation without affecting the tip’s flexibility).

4.Parameter Setting

Operate the color touch screen (PLC control system) to set test parameters (e.g., testing speed, displacement range, data storage quantity) according to the test standard (e.g., YY/T 1554-2017) or test requirements.

5.Initiate Testing

Start the test via the operation interface; the instrument will automatically apply force/bending action to the guidewire tip according to the set parameters.

6.Data Acquisition & Recording

The instrument will automatically collect and store test data (e.g., flexibility, bendability data) during the process (supports storing multiple groups like 200/500 groups).

7.Post-Test Operation

After the test is completed, stop the instrument, safely remove the tested guidewire, and check the integrity of the collected data.

8.Data Processing & Report Generation

Export the test data via the system, analyze the flexibility performance of the guidewire tip, and generate a test report (if the instrument supports report output).

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