Indications, Safety, and Warnings

The GI Genius™ intelligent endoscopy system is intended to be used by trained clinicians as an adjunct to video colonoscopy for the purpose of highlighting regions suspected to have visual characteristics consistent with different types of mucosal abnormalities. The whole colonoscopy video and highlighted regions still must be independently assessed by the clinician and appropriate actions taken according to the standard clinical practice.

The GI Genius™ intelligent endoscopy system is intended to be used as an adjunct to colonoscopy procedures and is not intended to replace endoscopist assessment or histopathological sampling.

The GI Genius™ intelligent endoscopy system does not make any elaboration or alteration of the colonoscopy video streaming, it only overlays graphical markers.

Device Description

The GI Genius™ intelligent endoscopy system is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology.

• Danger: Do not use this system for any purpose other than its intended use.
• Danger: The system does not perform any diagnosis.
• The GI Genius™ intelligent endoscopy system is compliant with IEC/EN 60601-1 and IEC/EN 60601-1-2 to be placed in the patient environment and to be safety connected to other IEC IEC/EN 60601-1 equipment.

Electrical risks

• DANGER: Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock. Keep fluids away from the system. If fluids are spilled on or into the system, immediately stop any operation of the system and refer to the IFU.
• DANGER: Do not use the system when not properly closed. Do not touch electrical contacts inside any component of the system.

Fire or Explosion Risks

• DANGER: In order to prevent fire and explosion, do not expose the system where:
  • there is a high concentration of oxygen
  • air contains oxidizing agents (e.g., N₂O)
  • air contains any flammable gases
  • there are flammable liquids nearby

Interferences

• WARNING: System may interfere with other equipment. Please refer to the IFU for further information.
• CAUTION: Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary such as reorienting or relocating this instrument or shielding the location. Do not use -CB-17-08 and its cable closer than 30 cm (12 inches). 

Electromagnetic fields

• WARNING: Do not use the system where there is a strong electromagnetic field (e.g., Magnetic Resonance, wireless devices, microwaves emitting devices, etc.).

Mechanical Forces

• CAUTION: While pressing buttons or touching the system, do not use hard or pointed objects or apply excessive force otherwise damage to the equipment will occur.

Connection and disconnections

• CAUTION: Do not connect/disconnect any cable of the system while any component is powered on, otherwise damage to the equipment will occur.