Multi-band Hemorrhoids Ligation Device Use Manual

Multi-band hemorrhoids ligation device is made of medical polymer materials, in line with the requirements of the production environment. The production process is in strictly accordance with the relevant regulations of product standards for registration.

Product Registration number:

Production License No.: Producing Certificate No.20081661 of Guangdong Food & Drug Instrument Administration

Implementation of Standards:YZB/GD0352-2009

Product Name: Multi-band hemorrhoids ligation device

Model Specifications: ZDFR-TZQ-01-type

Production Enterprises Name：Guangzhou Furui Medical Technology Company of Sun Yat-sen University

Production address: Main building 1102, C2 District, Science Road 182, Guangzhou Science City, China.

Phone: 020-32219976

Fax: 020-32219976

Contact：su xiaobin

Postal Code：510663

After-sales service Units: Guangzhou Furui Medical Technology Company of Sun Yat-sen University

Production use: Multi-band hemorrhoids ligation device is used for the following diseases:①various-phases internal hemorrhoids；②various-phases mixed hemorrhoid；③Rectal focally benign lesions, as rectal polyps and rectal hemangioma (vascular malformation), etc. Multi-band hemorrhoids ligation device has been sterilized in the factory.

Use Methods:

1. Unseal it along the part of packaging mouth, take out the multi-band hemorrhoids ligation device.

2. Check out whether there is a pollution or deterioration phenomenon prior to the use of the device.

3. The procedure of Multi-band hemorrhoid ligation device

— Place the patient in lateral decubitus ,knee-chest,or lithotomy position and sterilize the skin of surgical field.

— Insert the anoscope to expose the dentate line and the internal hemorrhoids. Sterilize the rectum and anal canal.

— Connect the negative pressure suction adapter to the negative pressure system and make sure the negative pressure releasing switch is closed.

— Place the barrel of the ligation device through the anoscope toward the target tissue..Aspirate the target tissue into the barrel under negative pressure. Maintain suction until the pressure reaches the value of －0.08～－0.1MPa,rotate the ratchet to expel rubber band around the hemorrhoid.

— Turn on the negative pressure releasing switch to release the ligated hemorrhoid (same as little finger tip in size).With the same method, move to the next hemorrhoid.

4. Main points for handling the device

— There are two methods for hemorrhoids ligation, one is direct hemorrhoid ligation and the other is suprahemorrhoid mucosa ligation. The former methods is to ligate the base mucosa of hemorrhoid ( 2cm above the denate line) and the latter one is to ligate the suprahemorrhoid mucosa( over 3~4cm above the denate line )respectively.

— Generally, for mild and moderate internal hemorrhoid, direct ligation alone is enough. For severe internal hemorrhoid, it would be better to combine the two methods .

— There are two combination pattern. One is either series connection pattern,with two ligation points ,one in the base ,the other on the hemorrhoid exactly over the base one ,the other is inverse isosceles triangle pattern, with three ligation points including one in the base and two on the hemorrhoid .

— Ligation can be applied at point of 1~2 o’clock, 5~6 o’clock and 9 o’clock in knee-chest position. Other points may also be available, depending on the location of specific hemorrhoid.

— It is better to ligate 2 to3 points, no more than 3 position at a time(It may also depend on individual experience).

— Repeat ligations at more than 4-week intervals if the hemorrhoid doesn’t shrink completely or hematochezia still exists, until remission or the symptoms disappear.

— Ligation should only be performed at least at 1.5cm above the dentate line in either method.Avoid ligating the dentate line or anal skin.Otherwise, it may cause sharp pain or a severe sense of fullness in rectum.Severe cases may expect bleeding or infection.

— Patient preparation:defecation or glycerine enema prior to procedure

— Ensure smooth bowel movements after the operation. And no spicy, alcohol .etc. Hip bath, ointment for external use, and the anal suppository medicines can be used. Antibiotics are rarely needed unless oral administration in special circumstances.

— Some cases may experience a sense of urgency or fullness in rectum which will resolve by symptomatic treatment. In patients with post-operation bleeding, Re-ligation or stitch is necessary under an anoscope.

Indications:

— Various-phases internal hemorrhoids

— Various-phases mixed hemorrhoids

— It can be used as a addition treatment for the patients whose retraction of hemorrhoids or anal “cushion” is incomplete after the procedure of hemorrhoids mucosal Circumcision (PPH) or other therapy.

— Other diseases: rectal focally lesions, such as colorectal polyps, colorectal hemangioma (vascular malformations) and so on.

Contraindications

— A simple external hemorrhoids.

— patients with the obstacles of hemorrhage and coagulation mechanisms

— The existence of other diseases for which clinicians do not consider it appropriate for ligation treatment.

Post- operation process

— The use of analgesics is allowed，as for patients who are more sensitive to pain.

— Choose appropriate ointment to squeeze into the anus and smear on the perianal skin after the procedure.

— Generally, the use of antibiotics is not necessary after the operation,unless the doctors make an administration in special circumstances.

— Avoid pungent food and alcohol. Rrecommended more water and foods that contain high cellulose including vegetables, fruits, bananas and so on.

— According to the patient’s condition, one can take a hip bath using appropriate solution after procedure

— The occasional postoperative bleeding can be stopped by supplementary ligations or sutures through an anoscope.

Technologic Specifications: Appearance, physical size, reduced substance(easily be oxidized), Aprons tensile strength, pH, biological performance, sterile, ethylene oxide residues.

Notes:

1. Do not open the package if not use.

2. One-time use, prohibite reusing or using a product that the sterile-grade packaging was damaged.

3. After use, please abide the one-time use medical supplies management to proceed the destruction.

Storage methods: Stored in a cool and dry place, where is non-corrosive gases, well-ventilated and the relative humidity is not more than 80%.

Production date or lot number (No.):

Expiration date for use: The product is valid within two years from the date of sterilization.

Manual Publication Date: 2008-08-15