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PRIMED INSTRUMENTS INC.

SuperDART® is the most sophisticated flexible endoscope channel cleaning device on the market today.

We conducted an independent study on the cleaning efficacy of the device in just ONE PASS ™ through the channel.

The study was done at an independent lab specializing in this type of work.
The protein reduction was significant and the residual protein levels were way below the 6.4 µg/cm2.
AAMI TIR:2020 calls for a protein level less than 6.4 µg/cm2 after cleaning and prior to sterilization/high level disinfection processes.
AAMI stands for Association for the Advancement of Medical Instrumentation.
TIR:2011 stands for A COMPENDIUM OF PROCESSES, MATERIALS, TEST METHODS, AND ACCEPTANCE CRITERIA FOR CLEANING REUSABLE MEDICAL DEVICES.

The protocol was established and followed for the most extreme soiling (channel full of soil) and extra long dwell time between the time of soiling and the time of processing (2hr, normal time is usually much shorter, plus bedside cleaning solutions are often used right after the scoping).
Used (scratched inside) channels were used for the study.

Results of the study confirmed very high efficacy of the device and we declare the SuperDART® to be suitable for cleaning contaminated channels in just one single swipe.

Click Here - Declaration of Product Performance Effectiveness for ONE PASS™

ONE PASS™ , validated manual cleaning, has significant advantages vs. standard brushes cleaning.

Standard brushes have to be passed through the channels 3-4 times, as all IFUs state, until there is no visible debris on the bristles. This is a very subjective criteria that depends on many uncontrolled factors, such as clarity of the detergent solution, lighting, operators’ alertness, operators’ vision, etc.… This uncertainty is eliminated when using SuperDART®


Furthermore, reducing the number of brush passes through the channels, reduces the processing time and operators’ fatigue and potential repetitive movement strain problems.

It is important to understand the difference between the SuperDART® and other squeegee type brushes. We incorporate three stage cleaning: Leading Brush, Squeegee Wiper and Tail Brush.

The Tail Brush at the end of the device is very important and differentializes our product from others. This brush scrubs off the debris from any scratches, dents, imperfections in the channel after the squeegee pass. Squeegees can not remove the bioburden from these imperfections (in fact the squeegees push the debris into these imperfections). The tail brush also removes any biofilm left by the squeegees in the channels.

Our competitors show flashy promotional videos of other squeegee-type devices where they "clean" a tube filled with red colored liquid. After two passes, the tube is squeaky clean with no visible red dyed liquid. These videos are misleading; all channels have scratches, dents, seams and other imperfections. Brand new perfectly smooth tubes were used for these videos. If this was a real channel the red liquid would have stayed in these imperfections.

The Squeegee Wiper in our device is securely attached onto a pair of the twisted wires which is part of the Tail Brush*. This provides for much greater flexibility of the squeegee element vs other products where the squeegee is placed on the stiff catheter tubes.

Flexibility is important for pulling the device through any bends in the scopes’ channels.

There are three important SuperDART® instructional notes for the users:

  • Aways use WET with a detergent/enzymatic solution - scope and the brush. NEVER use dry.
  • Only use for specified channels sizes
  • SuperDART® is a PULL THOUGH device. Always push the Leading Brush First (with white bullet) through the channel until it appears on its opposite end. Next, Pull Through the Squeegee Wiper and the Tail Brush through the channel to complete the process.

NEVER try to push the squeegee and tail brush section of the device into a channel.

*Patents pending


The devices are supplied non-sterile and are intended for single use only.          



DOWNLOAD THE SuperDART® BROCHURE IN PDF FORMAT


Prior to use, please read Instructions for Use insert.

DOWNLOAD THE SuperDART® IFU IN PDF FORMAT

WATCH THE SuperDART® INSTRUCTIONAL VIDEO THAT IS SUPPLEMENTARY TO THE IFU.








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