Multi-Lumen Catheter Leak Test System
The FDA requires process validation of medical devices such as a multi-lumen catheter, and, the design of a multi-lumen catheter must permit each lumen to be tested during the production process. Our Multi-lumen Catheter Leak Test System (MLC) provides an efficient and convenient way to validate up to 4 multi-lumen catheters simultaneously.
The Multi-Lumen Catheter test system uses Dynamic Mass Flow Technology providing direct readout of leak/flow rate and maximum speed and accuracy, enabling compliance to ISO 10555-1.
Capable of testing multi-lumen catheters for:
- External Leakage
- Inter-Lumen Leakage
- Flow Restriction Test for Occlusions
Results of each test are displayed on the front panel digital readout and can be permanently recorded by the optional printer or host computer.
User Friendly and Versatile
- Easy to Operate Menu Driven Programming
- 30 Part Number Holders
- RS-232C / Ethernet
- Data Acquisition
- Quick Change Catheter Sealing Cartridges
Robust Design Capable of ProductionRequirements
- Operator inserts the catheter in the sealing cartridge
- Attaches the luer fittings and presses “start”
- Lumens are then individually leak and flow tested in a matter of seconds
- Luer fittings automatically released on accepted parts
For greater productivity, a second station can be added to the MLC System so that one station is leak testing while the other is unloaded/loaded. Automatic removal of the fittings from the tester at the end of test is another option that accelerates the testing process.
For versatility and easy setup, a color menu-driven touch screen operator-interface displays available options. Also, individual test readings and batch reports are menu accessible via the operator-interface; the RS-232C data port or the external printer.
Fully Automated Leak and FlowTest
- Fast—complete test cycles in seconds
- Easy to operate
- 2, 3, 4 or 5 lumen catheters
- Leak rate sensitivity from 1cc/minute
- Pneumatic testing uses dry air or any gas
- Direct readout of leakage in cc/minute and flow rates in liters/minute (or other units if desired)
- Optional digital printout for permanent record
- Front panel pushbutton or remote switch input.
- Leak Rate Ranges: 0-10, 0-100, 0-1000 sccm pressures, minimum leak rate 1sccm.
- Flow Test Ranges: 0-1, 0-10, and 0-100 slpm ranges, typical.
- Available Test Ranges: 0-2, 0-5, 0-20, 0-100 psi.
- PanelView® 5.7” color LCD display with resistive touch screen for menu driven test setup.
- RS-232C output port provided for transmission of individual test readings and batch data reports.
- Integral panel mount or desktop printer
- Audible Alarm for reject parts
- Depends on options selected, typically: 17”(432mm) H x 20”(508mm) W x 24”(610mm) D.
- 105-125 VAC, 50/60 Hz
- 220 VAC, 50/60 Hz
Product information is subject to change without notice. Product images may include options or accessories not included with the base model.