Professional Supplier Disposable Stone Extraction Balloon

1. Intended Use:
Stone removal in biliary tract, including biliary sludge and residual gallstone left in biliary tract after Mechanical Lithotripsy.


2. Characteristics:
* Innovational design of three lumens(lumens for guide wire, injection and inflation)
makes the insertion and radiography easier and more convenient.
* Three different sizes for each balloon, meets demands of different patients.
* Equipped with Radiopaque marks on both ends of balloon, convenient for locating under X-ray.
* Unique design of tapering catheter, improves the insertion into palilla.


3. Specifications: 

4. Product Packaging:
1) Inner Packaging: The inner package is PE+ Dupont paper.
2) Middle Package: The middle package is 3-layer corrugated paper.
3) Outer Package: The outer package is 5-layer corrugated paper.

Operation Procedure
(1)Take product out of package, check if any twist or damage.
            (2)Assemble the inflator with the two-way valve, inflate the balloon to check if any leak. Do not use if any leakage.
            (3)Insert the deflated balloon into endoscope channel slowly until it comes out from the distal end of endoscope.  If guide wire is used for placing balloon, disinfectant or normal saline should be used to flush the guidewire channel. Recommend to use guidewire with φ0.88mm (0.0035"), length 4500mm.
            (4) Before insert balloon into bilary duct, contrast-medium shall be injected into the injection lumen to drive out the air.
(5) Guide balloon into biliary duct and place it upon the stone under the observation of X-ray. If necessary, inject contrast-medium.
            (6) Inflate the balloon by injectors with prearranged volume, turn off the two way valve, and pull the inflated balloon towards the papilla slowly. If the stones can't pass, EST should be considered.
            (7) Turn on the two-way valve, and withdraw the deflated balloon through the endoscope channel.   
            (8) Dispose the instrument as per the regulations in located institution.
            Note: Disposable stone extraction balloon is designed as two lumens and three lumens type, the three lumens type has one more injection lumen compared with the two lumens type. Three lumens type should be chosen if contrast-medium will be injected; two lumens type could be chosen if it is no need to inject contrast-medium.
Cautions 1. Do not use if package is damaged.
2. Do not use if product is over the expiry date.
3. This product is sterilized product, only for single use. Do not reuse it. After using this product, dispose it in an appropriate manner.
4. Contrast-medium must be injected under the observation of X-ray in ERCP operations.
5. Excess may cause pancreatitis.
6. Choose inflator with nominal volume as per the requirements of operation, only once injection is allowed, twice injection is forbidden.
7. This product can only be used by trained and experienced physicians and nurses.
Contraindications) Including but not limited to:
1. Patients contraindicated to ERCP and any particular simultaneous operation with extracting stones by balloons.
            2. Patients allergic to latex.
            3. Patients have coagulation functional disorder or hemorrhagic disease.
            4. Patients have acute inflammation or anabrosis in upper gastrointestinal tract
            5. Patients allergic to latex, contrast-medium or other chemicals used in operation.
            6. Patients do not grant to cooperate.

Package & Storage
The single package uses paper-poly bag; the middle package uses paper box and the outer package uses paper carton.
The product should be stored in ventilated, dry and non-corrosive room and the relative humidity should be not higher than 80%