CHANNEL CLEANER

Mechanical manual cleaning of endoscopes is the most critical part of instrument treatment: the use of microspheres consisting of more than one million fibers only a few microns in size enables effective, safe, repeatable, and fast channel brushing. Channel Cleaner is a unique disposable product, an alternative to traditional toothbrushes.

Description This disposable device is intended to brush and clean the inner walls of endoscope channels by suction of spheres. It was designed and developed to complement and enhance the manual cleaning and brushing phase. After treating the endoscope with the device follow the recommendations of local guidelines regarding manual cleaning and brushing as well as the endoscope manufacturer’s instructions regarding the same. Parts of the endoscope that cannot be brushed by the device should be cleaned and brushed according to local guidelines and the endoscope manufacturer. It is recommended not to use the device for purposes other than the one indicated. Use should be reserved for trained personnel. Operation and composition At the end of the endoscopic examination, the operator aspirates a cleaning solution into the channels of the endoscope in order to remove coarse dirt from patient secretions, mucus, or blood. Channel Cleaner is used at this stage of the cleaning process. The product is, in fact, sucked into the channels along with the cleaning solution. By suction, the spheres are aspirated from the tip of the endoscope, pass through the biopsy and suction channel, and are ejected through the outlet of the suction channel. The balls are retrieved by means of a trap by which the operator is able to verify the proper ejection of all three balls. Suction of the balls through the channels allows them to be cleaned and the walls brushed. The device consists of a cartridge containing the balls and a container for the cleaning solution in which the cartridge itself is housed.

Upon completion of daily procedures, immerse the trap in a cleaning solution and then wash with ultrasound. After washing, disinfect the trap, rinse and dry. The trap is reusable. The cartridge is disposable: do not reuse. Specifications and compatible endoscopes Below are the insertion tube and biopsy channel diameters of the endoscopes to which the product fits. Biopsy channel diameter:

• 1.8/2.2 mm, e.g., bronchoscope (product code CMD-BB1120D; green cartridge);
• 2.8 mm, e.g., gastroscope (product code CMD-BB1128D; yellow cartridge);
• 3.2/3.8 mm, e.g., colonoscope (product code CMD-BB1132D; orange cartridge).

Outer diameter of the endoscope: 8 – 18 mm. The device should be used only on channels of the above diameters. The device should not be used for duodenoscopes. Materials Cartridge: polypropylene; Trap: polymethylpentene; Container: polypropylene. Storage Store in a clean place, away from direct light, at room temperature and normal humidity. It is recommended to store in a capable container suitable for maintaining clean conditions and not exposed to water or heat sources. Cartridges and containers should be stored in suitable boxes to prevent sagging due to weight, etc… The balls contained in a cartridge may dislodge. It is recommended to store the boxes in places protected from vibration. Disposal of the device Subject to local regulations. Directives and compliance Channel Cleaner is designed and manufactured in accordance with the provisions of the Medical Device Directive 93/42/EEC of June 14, 1993 implemented by Decree-Law No. 24 February 1997. 46 as amended (class I medical device, nonsterile, CE mark). The harmonized standards applicable to the product are as follows: ISO 9001/2008, ISO 14971/2000.