The Interventional Device Testing Equipment
The Interventional Device Testing Equipment (Push Track Tester IDTE 2000) from MSI is the state of the art catheter testing equipment. The IDTE is designed to comparatively and quantitatively tests and records the performance features of interventional devices including: catheters, guidewires, stent delivery systems, colonoscopes,endoscopes and scope tools. IDTE’s PC controls and versatile test configurations allow for simple and repeatable test setups and instantaneous feedback on device design changes, there by reducing design timelines. Test results can be used for regulatory submissions, competitive product testing and R&D device evaluation. This catheter testing equipment was designed with several international testing standards in mind. These include: ASTM F2394-07 for preconditioning of the stent on the deployment system prior to retention testing, ISO Standard 25539-1:2003(E) Titled “Cardiovascular Implants – Endovascular Devices” and ISO/TS15539:2000(E) Titled “Cardiovascular Implants Endovascular Prostheses”. While still adhering to published guidance standards, the IDTE allows users to distinguish their products from competitors by creating and testing in extremely challenging conditions.
IDTE 2000 - Catheter Testing Equipment features:
- Set-up and calibration
- Data Acquisition system; data is saved in a CSV (Comma Separated Variable) format and a PDF format for a secure copy. Machine Options:
- Integrated video capture system, with data and video linked in time
- Torque measurement package for Torquability, Torque to Failure and Steerability testing
- Two live roller systems
- Double roller system with 3kg load cell
- High force roller system with 6 or 12kg load cell
- Custom size water bath
• Adjustable track configuration with two dimensional and three dimensional • testing capabilities. • Semi-enclosed heated water bath system (+/- 2°C). • Adjustable flow control through the path with luer fitting. • PC with Windows XP operating system. • Touch screen machine operation. • Catheter holding tray. • Two (2) auxiliary load cell inputs for optional equipment. • One (1) push test distal load cell fixture (1kg). • Spring activated segmental alignment mechanism.
• Stepper motor driven flip top urethane roller system for easy product loading. • Micrometer adjustment for various product diameters and repeatable product • compression. • Encoder position feedback.• Integrated load cell (1kg).• Adjustable position to accommodate various introducer lengths.
• Software written with Visual Basic 6.0. • Adjustable testing parameters include: advancement distance, advancement • rate, data averaging rate, direction of motion, and track, push, cycle • or torque testing. • Sequential numbering system for rapid batch testing. • Unlimited testing profiles. • Password protected areas: set-up and calibration. • Data Acquisition system; data is saved in a CSV (Comma Separated • Variable) format and a PDF format for a secure copy.
• Integrated video capture system, with data and video linked in time.• Torque measurement package for Torquability, Torque to Failure and • Steerability testing.• Two live roller systems• Double roller system with 3kg load cell. • High force roller system with 6 or 12kg load cell. • Custom size water bath.
IDTE 2000 – ASIS configuration:
- Machine Voltage: 240V
- Manufactured – 09/2008
- 1 Double roller system (motor 2) with 3kg load cell and encoder
- 1 Single roller system (motor 1) with 1kg load cell and encoder
- 1 Windows XP control system
- 1 Long tank 45"Lx19"Wx16"D
- 1 Distal load cell 1kg
- 2 Auxiliary Load cell 100g
- 1 Video cam system
- 1 Plane laser beam generator Laser Line Generator Assembly
- 1 Vision assembly with 2 lights
- 2 Constant flow pump
- 1 Level sensor
- 1 Temperature control system with heater
- 2 Proximal calibration pulley
- 2 Proximal calibration cable
- 1 Distal/auxiliaire calibration pulley
- 2 Distal/auxiliaire calibration cable
- 1 Side straight port assembly
- Power cords type E only – Type J not included
- Prewired - No torque module