Endoscopic System

 

 

 

 

 

BLACK EYE™ is a sterile, non-pyrogenic ink designed to be used as an endoscopic marker for marking polyps and lesions in the gastrointestinal tract.
It is supplied syringe contain 5ml of the marker.
Ink is sterilized and ascetically packaged in the syringe, It is supplied sterile and disposable.
BLACK EYE™ is indicated for endoscopically marking lesion in the GI track when the endoscopist anticipates the lesion will require surgical removal within 30 days.

BLACK EYE™ is substantially equivalent to the predicate colon marker.
BLACK EYE™ and the predicate device have same indications for use.
Both are carbon black formulations that are used for endoscopically tattoing or marking the colon.

Advantages of Black Eye™

Safe from Contamination
The use of India ink or methylene blue can be contaminated easily during the preparation or use of the injection solution.
As the Black Eye™ is supplied sterile and disposable, you can be safe from the danger of contamination of the patient.

Biocompatible
The India ink for industrial use contains micro-organisms, heavy metals and dangerous chemicals like phenol, ammonia, etc.
The Black Eye™ is made of only safe and biocompatible materials which are passed through the cytotoxicity, sensitization and irritation tests by ISO 10993 standards.

Clear Identification
As the methylene blue or Indocyanine green are dye, it is soluble in the body around a couple of days.
However the main materials of the Black Eye™ are insoluble pigments, they remain in the body as markings permanently.

Easy to use
It would be very complicated and irritating to use the India ink, methylene blue or Indocyanine etc.
The use of the Black Eye™ is just to take from the package and connect it to the injection needle.


BLUE EYE™ Submucosal Injection Agent

Blue EYE™ is a medical device that is an injectable liquid composition intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to removal with a snare or endoscopic device.

It facilitates endoscopic resection procedures during endoscopic examinations in the upper and lower gastrointestinal tract, such as the esophagus, the stomach.

1. Blue EYE™ is easy to use.

Unlike conventional ampoule products, Blue EYE™ is easy to use because it can be connected directly with the injection needle.

2. Blue EYE™ is safe from contamination.

Blue EYE™ is packaged in a ready-to-use syringe with steam-sterilized solution that connects directly to the injection needle with a Luer-lock to eliminate the risk of cross-contamination by preventing air exposure.

3. Blue EYE™ is effective.

Blue EYE™ has twice longer-lasting mucosal elevation than normal saline, which reduces entire procedure time and side effects such as perforation, which increases the success rate of the endoscopic procedure.

4. Blue EYE™ is biocompatible.

Blue EYE™ is biocompatible; it contains hyaluronic acid, a biopolymer naturally present in the human dermis.

TS-905 Blue Eye™

ready-to-use Submucosal Injection Agent with methylene blue.

Advantages of Blue Eye™

Important Safety Information

– WARNINGS AND PRECAUTIONS

º The safety of Blue EYE™ has not been established in pregnant or lactating women, or in children under 18 years of age.

º The endoscopist injecting Blue EYE™ must be experienced in the administration technique.

– ADVERSE REACTIONS

º Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Blue EYE™.

– CONTRADICTIONS

º Patients with known sensitivity to any of the components contained in Blue EYE™. Please see Instructions for Use for complete Important Safety Information.


See More. Diagnose Smarter.

Experience the 360°difference with the all-new CapsoCam Plus® Video Capsule Endoscopy.

CapsoCam Plus video capsule endoscopy  is designed to improve diagnostic confidence by providing a full 360º panoramic lateral view of the small bowel mucosa. More detailed imaging and a larger vertical field of view allow for better tissue characterization.

Higher Resolution. Greater Clarity.

The imaging hardware in CapsoCam Plus has been redesigned and optimized to deliver a more thorough view of the small bowel mucosa. With higher resolution and double the memory, CapsoCam Plus provides the most comprehensive imaging available today. More detailed imaging allows for greater diagnostic confidence.

ampulla of vater

Ampulla of Vater

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Crohn’s Disease

ectasia

Ectasia

Melanoma

Melanoma

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Submucosal Mass


 

 

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