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. |
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