Dynatek dalta | CDT Medical Device Testing

CDT

Coating Durability Tester

Insertion of medical devices into the vascular system, particularly coated devices, poses the risk of causing embolic events from particulate loss. Dynatek’s Coating Durability Tester provides for accelerated evaluation of particulate loss from coated and drug-eluting stents and other medical devices where particulate generation is of concern.

How it Works:

Dynatek’s Coating Durability Tester utilizes Dynatek’s Hyper Drive electromagnetic motor to produce an adjustable bellows compression at rates up to 150Hz, which allows for physiologically-relevant stent loading conditions at physiological or highly-accelerated rates. In addition, a unidirectional-flow of pre-filtered testing solution through the test samples and through in-line laser particle counters allows for particle counting in real-time.

Coating Durability Tester

Dynatek’s CDT offers the following particulate loss testing capabilities:

Highly-controlled stent loading (expansion and contraction) in a pulsatile environment with pulse rates from 1 to 150Hz. Testing speed, sample pressures, and stent deflection are easily adjusted on-the-fly without affecting data collection.
Laser particle counting to detect shed particles in real-time, and identify the size and number of shed particles. The user will know the precise time period in which particles are shed.
Ability to test multiple samples simultaneously.
Unique bypass filtration system that allows for removal of the filters without interrupting the test.
Parameter modification capabilities let the user choose the size of particles to be detected, and group the particles by size range.
Compatibility with compliant silicone vessels allows for the closest in vitro representation of in vivo environments.
Frequency, temperature and pressure controls give the user the ability to determine the techniques and parameters for testing.
Combination of flow volume control and known data logging intervals allows data to be readily evaluated against U.S. Pharmacopeia Standard 788 for large volume infusions.

CDT Specifications:

Footprint: 48” x 60”
Power Requirements: 115V AC
Dry Weight: 300 lbs.
Flow Rate through each sample: 100 ml/min
Sample Tube Diameter: up to 15mm
Sample Tube Length: up to 20cm
Number of Samples: 5
Number of Pressure Transducers: 5
Temperature Range: up to 45°C
Speed: 1-150 Hz
Measurable Pressure Range: 0 to 6 psi
Temperature Accuracy: ± 0.3°C
Particle Counters: 5
Particle Size Range: 4-100 micron
Particle Count Range: 4-1000 micron
Calibration of Particle Counters: ASTM Standard
Filter Assembly: 0.2 micron particulate filtration