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DEC™ Video Duodenoscope ED34-i10T2

Raising the standard of health

PENTAX Medical is delivering a unique and innovative advancement in cleaning capabilities for infection prevention and control: the Video Duodenoscope ED34-i10T2, with the single-patient use, sterile, disposable elevator cap (DEC™). 

This pioneering solution for diagnostic and therapeutic endoscopic retrograde cholangio-pancreatography (ERCP) procedures combines improved medical device hygiene clinical control with HD image quality (HD+) and procedural performance. 

DEC™, with its disposable elevator, responds to the need for enhanced patient safety in endoscopy. This need comes as a result of increasing incidences of Carbapenem-resistant Enterobacteriaceae (CRE) and other infections, which may also be linked to improper cleaning and/or disinfection of a duodenoscope’s elevator mechanism.

The PENTAX Medical Video Duodenoscope ED34-i10T2 combines a sterile disposable elevator cap (DEC™) for single-patient use and simple disposal that advances cleaning capability of the duodenoscope to help reducing risk of cross-contamination and improve patient care with High-Definition image quality for detailed endoscopic visualization during ERCP procedures.

Maximize infection prevention, reduce risk

The DEC™ allows simplified reprocessing and increased cleaning capability, and thus helps reducing the risk for cross-contamination.

Reliable therapeutic performance

PENTAX Medical’s first duodenoscope with a disposable elevator that offers HD+ image quality for detailed visualization of the papilla for high precision in ERCP prodcedures.

Reprocessing operational efficiency

35% reduction in distal end reprocessing* due to better access for cleaning and disinfection as well as disposability of the elevator.

*In comparison to the standard duodenoscopes of the major manufacturers. Source: PENTAX Medical internal benchmarking.

Maximize infection prevention, reduce risk

Risks factors associated with endoscope infection outbreaks

Bacterial contamination of duodenoscope and accessories in U.S. Report dated from 2012 to 2017. The data might vary in the future according to new reports. Source: FDA Maude Report.

"ERCP is associated with the highest risk of infectious complications among all gastrointestinal endoscopic procedures."

Verfaillie et al, Endoscopy 2015; 47: 493–502


The PENTAX Medical solution

The innovative design of the PENTAX Medical DECTM Duodenoscope introduces a unique solution in the market and simplifies the overall reprocessing process.


The elevator cap is designed as a disposable component

The elevator area of the duodenoscope is one of the most difficult components to clean. With the DECTM Duodenoscope design, this challenge is overcome through the elevator integration into the disposable distal end cap.

"Manufacturers may consider enhanced design to ensure the adequate reprocessing of ERCP endoscopes and other complex reusable instrumentation, to further minimize the risk of disease transmission during GI endoscopy."

Muscarella et al. World J Gastrointest Endosc 2014 October 16; 6(10): 457-474 ISSN 1948-5190

Reliable therapeutic performance

Confidence when delivering therapy 

The ED34-i10T2 is a duodenoscope providing High-Definition endoscopic images
for routine and therapeutic ERCP procedures. HD+ combined with i-scan allows for better visualization of the lesion and fascilitates easier cannulation. Combined with i-scan and i-scan OE, detailed visualization of the mucosal structures is possible to support detection and characterization of lesions and help locate the minor papillae.


Precise control

Material couplings and the disposable design allow the use of a new elevator every time a procedure is performed, with no risk of wear-out-effects. The improved elevator shape and ergonomic design of the duodenoscope facilitate easy cannulation as well as precise and controlled positioning of devices during ERCP procedures.


Optimized visualization

HD+ imaging  allows better visualization and anatomical interpretation of papillary structures, for an easier cannulation of the ducts. i-scan can be used to highlight and assess lesions.

i-scan facilitates the visualization of the orifice of the papilla
i-scan OE increases contrast and visualizes vascular patterns
i-scan can be used to highlight adenomas pit pattern structures
i-scan OE can help to precisely visualize the area to be ablate

Reprocessing operational efficiency

The re-engineered and innovative distal end of the PENTAX Medical DECTM Duodenoscope allows direct access and exposure to critical surfaces for brushing, cleaning and disinfection.


The disposable elevator cap: better benefit through disposability 

Thanks to the distal end cap’s single-patient-use design with its integrated elevator there is no need for elevator reprocessing.


Distal end with open access

The DEC™ Duodenoscope distal end, a crucial element for the prevention of patient infection, has been designed to offer easier access for brushing. PROfILE single-use cleaning brushes were made to meet the high-quality standards of PENTAX Medical engineering.These brushes have been specifically designed for PENTAX Medical and were tested to reduce residual soil compared to legacy brushes.

PENTAX Medical recommends to reprocess the DECTM Duodenoscope by using PROfILE single-use cleaning brushes.

35%

reduction in steps for distal end reprocessing*

* In comparison to the standard duodenoscopes of the major manufacturers. Source: PENTAX Medical internal benchmarking.