Balloon inflation deflation device
Balloon Inflation Deflation: Equipment features
- Inflation pressures up to 30 bars
- Pressure controlled testing or flow controlled testing
- Variable inflation ramp rate
- High fidelity pressure difference sensor (accuracy +/- 1 mmHg FS)
- Sampling frequency = 1Khz
- Dedicated control software to set number of test cycles (balloon fatigue test), automatic leak detection, dwell times
- Dedicated support for balloon catheters on demand
- Thermo regulated bath on demand
Balloon Inflation Deflation: Scope
- Angioplasty balloon catheter testing
- PTA, PTCA balloon catheter testing
- Any interventional systems with balloon technology testing
- Any delivery system with balloon technology testing
Balloon Inflation Deflation: Applicable standard
- ISO 10555-1 2009 - STERILE, SINGLE-USE INTRAVASCULAR CATHETERS — PART 1: GENERAL REQUIREMENTS
- ISO 25539-2 - CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 2: VASCULAR STENTS
- FDA GUIDANCE. CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT FOR CERTAIN PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETERS.
- FDA GUIDANCE. GUIDANCE FOR INDUSTRY AND FDA STAFF NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS
Balloon Inflation Deflation: Associated tests
- Balloon fatigue assessment
- Inflation and deflation time measurement
- Rate burst pressure determination
- Balloon compliance assessment
- Acute particulate evaluation
- Radiopacity
- Optical Inspection
- Any balloon expandable stent performance tests
Our automatic inflation/deflation device includes a dilation syringe and a software controlled stepping motor. Automatic and precise measurement of pressure signal vs. time to characterize any balloon catheter functional performance. Repeatability of measurements. Operator unbiased comparative testing.
Balloon Inflation Deflation: Equipment specification
- Inflation pressures up to 30 bars
- Pressure controlled testing or flow controlled testing
- Variable inflation ramp rate
- High fidelity pressure difference sensor (accuracy +/- 1 mmHg FS)
- Sampling frequency = 1Khz
- Dedicated control software to set number of test cycles ( balloon fatigue test), automatic leak detection, dwell times
- Customized design for all balloon catheters and balloon based delivery systems
- Thermo regulated bath available on demand