Intended Use:

The Multiband Ligator (FOCUZ BAND TM) is used via endoscope to legate esophageal varies at and above the esophago-gastricl junction. The Multiband Ligator and Set is supplied non-sterile and is intended for single use only.

Contraindication:

The contraindications include without being limited to cricopharyngeal or esophageal narrowing/stricture, tortuous esophageal diverticulitis, known or suspected esophageal perforation, asymptomatic rings or webs, coagulopathy. Use of ligation bands is contraindicated in patients with a known hyper sensitivity to latex.

Possible Complications:

Possible complications associated with the gastrointestinal endoscopy include but not limited to perforations, fever, aspirations, hemorrhage, infections, hypotension, allergic reactions to medication, cardiac arrhythmia or arrest, and respiratory depression or arrest. Furthermore, complications that may occur with esophageal banding include but not limited to chest tightness, retrosternal pain, dysphasia or odynophagia, post-EVL ulcer with or without bleeding, increase of portal hypertensive gastropathy, bacteremia, nausea, laryngeal, retrosternal pain, laceration, stricture formation, esophageal perforation and obstructions.

Precautions

It is vital that biopsy channel size of the endoscope is co-ordinate with compatible devices in order to obtain the optimal results during the procedure. The minimum biopsy channel diameter required is 2.8 mm and length of up to 150 cm. The outer diameter of the scope to be used must be from 8.6 mm up to 10.8 mm. Band ligation may not be effective when applied to small varices. It is vital to ensure the understanding of the technical principles, clinical applications and associated risks with endoscopy as well as endoscopic banding before using this product. This product must only be used by or under direct supervision of physician thoroughly trained in therapeutic endoscopy as well as variceal banding. Esophageal ligators are not intended for ligation of varices below the gastro-esophageal junction. Banding should begin at the gastro-esophageal junction and proceed up the esophagus in spiral manner, respecting a minimum of 2cm in between two band ligations. Passing the endoscope over an already legated varix may dislodge the FOCUZ BAND™ from its position. Routine endoscopic examination by the physician is recommended to confirm the diagnosis requiring treatment of esophageal varices or internal hemorrhoids prior to assembling the Multiband Ligator and Set.

Product Description

1. Multiband Ligator and Set is composed of the following parts:

   

2. Materials Required:

   • Handle: ACRILIC/ABS
   • Trigger code: LINEN
   • Barrel cap: POLYCARBONATE and POLYURETHANE/SILICON
   • O-Ring: LATEX

Warnings:

1. Please ensure that inner package has not been opened or damaged.
2. Only physician/surgeon who has received appropriate training should perform the treatment.
3. Treatment should only be performed at hospitals where surgery can be readily performed.
4. This device must not be reused in another procedure.
5. This product is not intended or approved for other applications.

Operating Procedure:

1. Unpack and check all parts of the system carefully. Ensure that all parts are in the package. Check the barcode or QR code and look for the expiry date.
2. The tracking wire of the Multiband Ligator should be mounted into an introduction catheter which is 150 cm long with a hook at its proximal end to catch the tracking wire.
3. Straighten the endoscope. We recommend the use of a biopsy valve. Keep its lid open. Fix the handle inside the biopsy channel port. Insert the catheter into the biopsy channel until it comes out of the distal tip of the scope.
4. Take the band barrel loop and connect it with the tracking wire loop properly as shown below making a flat knot.
5. Mount the band barrel on the tip of the scope and ensure that the soft part is properly fixed on the scope in a way that it cannot fall off.
6. Rotate the band barrel clockwise in order to prevent the tracking wire being in front of the endoscope camera.
7. Lubricate the scope and exterior part of the band barrel ensuring that no lubricant has entered the barrel.
8. Roll back the big wheel 180° to permit that the tracking wires is not fully straightened so that no band is shot while inserting the endoscope into the patient.
9. Locate the selected varix and aspirate it into the band barrel. When in place, tension again the tracking wire using the small wheel to prepare for the shooting.
10. Be sure that the alignment arrows on the handle are facing each other. Release the suction button of the scope, insufflate air and then withdraw the scope slightly to release the ligated varices. Locate the selected varix and aspirate it into the band barrel.
11. In case additional bands are needed, remove the endoscope and attach a new Multiband Ligator starting from 7.
12. Once the ligation procedure is completed, remove the endoscope from the patient carefully.
13. If any unused bands are still on the barrel shoot all remaining bands and discard. Remove the Multiband Ligator handle from the biopsy channel by pulling it; the remaining tracking wire attached with the handle should be removed. Remove the band barrel from the scope tip.

Target Population:

This device is intended for use in adult patients (≥18 years of age).

Intended Users:

This device is intended for use by trained and qualified healthcare professionals experienced in endoscopic and/or interventional procedures.

Product Disposal:

After use, this product may be a potential biohazard. Handle and dispose of in accordance with hospital, local and administrative laws and regulations.

Product support:

In case of questions or difficulties concerning our instruments please Contact your local distributor or Focuz Medical Technologies LLP directly during Regular working hours.

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