BMEG 456 Chapter Notes - Chapter 1: Sphygmomanometer, Minimally Invasive Procedures, Camera Control Unit
Document Summary
Intended use statement: risk classification according to canadian medical device regulations, brief summary of principle of operation, at least one example of a commercial device (manufacturer, model, endoscopes. Endoscopes are classified as class ii as they are invasive devices meant to penetrate the body by rule. The intended use for endoscopic surgical procedures in order to view and look inside the body with a camera for both diagnostic and therapeutic interventions in a minimally invasive surgery. The device typically consists of a camera control unit and a camera at the end of the endoscope. The endoscope is entered through the mouth into the gastrointestinal tract to look into the organs. The camera can be controlled and typically a light is also part of the device. There are also come that can be used through a small incision on the body. An example is 3 ccd hd endocam 5550 by richard wolf medical instruments corp.
