LEGAL STATEMENT

Product Information

3D Electronic Endoscope applies chip-on-tip structure including two high-resolution imaging objective lenses. On the basis of providing the full HD resolution of dual images, 3D Electronic Endoscope reduces the weight of the endoscope largely by avoiding applying the traditional optical structure. The 3D imaging and rich color performance allow the details of the surgical field to be presented accurately. The enhanced visualization and the precise display of the anatomy of human organs provide greater convenience for surgeons and shorten their learning curves.

 

 

Intended Purpose

3D Electronic Endoscope is intended for direct visual inspection of thoracic cavity and abdominal cavity for diagnostic or therapeutic purposes. It is designed to be used with an endoscopic imaging processor which could display images on a video monitor and make photography for targeted regions.

 

Instructions for Use (IFU)

The paper IFU is provided for and only for customers who have purchased this product. To obtain one, please contact Customer Service. Mailing service is available.
Customer service hotline: 00-86-400-900-3155
Customer service E-mail: MB_customer@microport.com

 

 

Please Note

For clarifications for and help, please contact your local representative. This product and its IFU are applicable to the European Union and comply with applicable laws and regulations of the European Union, especially the Regulation (EU) 2017/745(MDR).

 

 

Technical Data

 

 

 

Compatibility

This product should be used with an endoscopic imaging processor (model: EVP-G2) produced by Shanghai MicroPort MedBot (Group) Co., Ltd., and a medical cold light source that meets the requirements of local regulations and standards.

 

 

Safety

 

 

 

Contraindications

This product should not be used if any of the following contraindications exists:

(1)Patients who should not or need not accept endoscopic surgery / examination, probably due to inappropriate health condition or lack of necessary indications specified by relevant medical and health authorities or endoscopy societies.

(2)Usage of the product with incompatible instruments.

(3)Other contraindications specified by relevant medical and health authorities or endoscopy societies.

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