Single-use disposable laparoscopic/endoscopic devices, such as access ports and trocars, and disposable handheld and robotic laparoscopic/endoscopic instruments have become important tools used in many common patient surgeries. These devices include a wide variety of trocars and access ports, staplers, suturing devices, forceps, retractors, and more.
Due to the vital and precise role these devices play in the field, 100% of devices often need to be accurately and reliably leak tested to ensure proper functioning. CTS delivers trusted instruments for reliable seal testing and blockage testing, offering precise measurement and sensitivity required for repeatable testing of these critical medical devices.
Testing of these types of assemblies often requires a multi-step process to detect both leaks and potential blockages. These tests are designed to catch any leaks that may be caused during the assembly process where various engineered slitted aperture seals exist.
We typically suggest using dry compressed air mass flow methods, with testing pressures ranging from 10 - 20 mmHg or 0.2 – 0.4 psig (approximate typical laparoscopic insufflation pressure). Download the application bulletin below for a full review of the leak and blockage testing steps and methods for laparoscopy/endoscopy access ports and trocars.
Due to the function of these devices in the field, many of these instruments have complex structures and may contain a network of seals designed to prevent loss of insufflated gasses once inserted. Thus, testing of these types of assemblies for leaks is performed to confirm correct placement of each seal within the cannula of the instrument and ensure gross leaks will not allow massive gas loss during procedures.
Leak testing is a critical part of your manufacturing process. We understand the needs of medical manufacturers and have the experience and instruments to meet your test requirements, helping you reduce cycle time, ensure accuracy, and control product quality. Contact us to learn how the single-channel Sentinel Blackbelt or multi-channel Sentinel Blackbelt Pro could be implemented on your medical device manufacturing line.