Disposable Savary Gillard Dilator Bougie Dilator

• Type: Endoscopic Device
• Material: Plastic
• Ethylene Oxide Sterilization: Ethylene Oxide Sterilization
• Quality Guarantee Period: Two Years
• Group: Adult
• Logo Printing: With Logo Printing
• Model NO.: JHK
• Certification: CE, SGS, ISO13485
• O.D: 5-12mm
• Mark: with
• Transport Package: Cartons
• Specification: CE, ISO
• Trademark: Global, Jiuhong, OEM
• Origin: China
• HS Code: 90189090
• Production Capacity: 500000000

Product Description

1.2  Intended use
It is intended to use for the dilation therapy of digestive tract and cardia stricture.
1.3 Product Classification
    In terms of Rule 5, Annex IX in Medical Device Directive (MDD), Non-sterilized Bougie Dilator Set is an invasive device and the classification is Class I, Sterilized ones belong to Class I*.
1.4 Types
    According to different diameters of Bougie Dilator Set, it can be classified into 16 specifications, including Φ5, Φ6, Φ7, Φ8, Φ9,Φ10, Φ11, Φ12, Φ13, Φ14, Φ15, Φ16, Φ17,Φ18, Φ19 and Φ20.
1.5 Product features
Our Bougie has a medium softness; it can dilate easily and won't bring too much trauma with the smooth anterior taper, it also has stable chemical properties, good biocompatibility.
1.6 Indication
Patients with Esophageal stenosis and cardia stenosis
1.7Contraindications
Esophagus anastomotic stenosis tumor recurrence; anastomotic stenosis after esophageal surgery in 3 weeks; acute inflammatory period after burn of esophagus; serious hypertension, coronary heart disease, pulmonary incompetence patient, actual situation of patients shall be judged by professional physicians.
1.8 Cautions
(1) Read Instructions for use carefully before use;
 (2) The operators shall be trained physicians;
(3) The product is classified into sterilized and non-sterilized: the sterilized product is single use; while non-sterilized product shall be cleaned and disinfected before use. After application, clean the outer surface of bougie with fluid water and wash the inner bore with injector; wash the guide wire with ultrasonic cleaner.
(4) Dilate with bougie should be slowly and carefully, choose suitable diameter of bougie, do not use too big bougie directly.
(5) Do not use if the bougie appears undesirable phenomenon such as crack and rigidity. Do not use if the bougie has been worn or deformed.
 
    (6) Guide wire shall be checked carefully before use, do not use if there is any damage or corrosion.

1. 2 Materials

The materials of Bougie Dilator Set should be in accordance with the requirements in Table 1:
Table1 Materials

Component	Material	Standard
Bougie	PVC	EN ISO 1060-1-1999
Radiopaque Mark	X5CrNi18-10	EN10088-1-2005
Guide wire	Niti wire	ASTM F 2063-05
Safety spring	X5CrNi18-10	EN10088-1-2005
Inner Developing Pipe	X5CrNi18-10	EN10088-1-2005

Guide wire is made of Niti wire which has better flexibility and not easy to bend. It is often used for medical instruments and its biocompatibility, safety and reliability has been proven.

Specifications:

Model	O.D.(mm)	Length(mm)	Characteristics
JHK	5,7,9,11,13,15	850	Each set is equipped with 6 dilators and 1guidewire. With sign of visualization under X-ray and sign of calibration.