Gastric Calibration Tube 36fr - without balloon

Instruction for Use

—— I Type

[Product name] 

Gastric calibration tube

[Model specification] 

I Type： 32 Fr, 34 Fr, 36 Fr, 38 Fr, 40 Fr.

The basic size of the I Type                  Size:mm

[Structural composition] 

The gastric calibration tube is composed of catheter, inner cone joint, silicone head, universal connector and check clip. The product is provided sterile, sterilized by ethylene oxide and disposable use. 

[Scope of application]

The gastric calibration tube is used to calibrate the dimensions and position of the gastric pouch during a Gastric Bypass, Mini Gastric Bypass or Sleeve Gastrectomy procedure, as well as during revision surgery for these procedures. The gastric calibration tube can also be used to test the gastric pouch for leaks.

[Usage method]

The Calibration Tube is introduced orally until it reaches the positioning site. Once the gastric pouch has been completed, a leak test can be performed. For this purpose, a syringe is connected using the universal connector and air or liquid is introduced into the stomach segment. The tube can be closed as required using the tube closure clip. Following completion of the leak test, the liquid is aspirated via the holes in the gastric calibration tube.

[Age group suitability]

Adults older than 18 years old

[Intended patient population]

Patients who suitable for laparoscopic sleeve gastrectomy and is use for determining that volume of the require residual stomach.

[Intended user]

Healthcare professional.

[Intended environment]

Medical institution.

[Performance characteristics]

Conforms to Standard EN1618 1997 IDT，ASTM F2528-06:2023

[Warning]

• This product is suitable for adults who need to empty, clean and irrigate the stomach during gastric surgery.

•Do not use if the product is contaminated or has foreign bodies, defects or ruptured.

• To prevent cross infection, use for one person only.

• This product is a disposable product, do not reuse, must be used under the guidance of medical personnel.

• Check whether the package is intact before sterile use. If the package is found damaged, it is strictly prohibited to use.

• Confirm the packaging mark, production date and validity period before use, and use within the validity period.

•The stomach tube is made of silicone rubber. In special cases, follow the doctor's advice.

•This product is for one-time use, please follow the local health authority waste disposal method.

•A notice to the user and/or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

[Contraindication] 

• Zenker's diverticulum  

• Oesophageal varices  

• Oesophageal stricture  

• Upside-down stomach