The ManoScan™ system provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of Oddi, small bowel, colon, duodenum, and anorectal organs. It is used in a medical clinical setting to acquire pressures and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by medically-trained personnel for diagnostic and analytic purposes. The ManoScan™ HRM modules provide high-resolution and/or 3D (three dimensional) display of the pressure and impedance data. The ManoScan™ CLT module provides conventional line trace mapping of the pressure data and can be used as a stand-alone system or as a module of the ManoScan™ high-resolution manometry system.
To avoid risk of electric shock, this equipment must only be connected to a mains supply with protective earth. Do not position the system in a way that would make it difficult to disconnect the system from the mains power supply. Do not modify this equipment in any way. Do not use the device around anesthetic gases mixed with air, oxygen, or nitrous oxide. Danger of electrical ignition. The device is not compatible for use in an MRI magnetic field. Electrical equipment for medical use requires special EMC precautions and needs to be installed and serviced according to the EMC documentation of the device.
Portable and mobile RF communication equipment can affect electrical equipment for medical use. Given imaging is only responsible for the reliability and performance of the device if the following guidelines are strictly observed:
If these guidelines are violated, the warranty will be invalid.
The use of the ManoScan™ system for pharyngeal/esophageal motility study and proximal gut (gastric/duodenal) manometry is contraindicated for the following:
The use of the ManoScan™ system for anorectal manometry is contraindicated for patients with known anal stricture/obstruction preventing insertion of the instrument.
Nasal passage insertion
Potential adverse events associated with the use of this system and catheter insertion into the nasal passage may include:
Potential adverse events associated with the use of this system and catheter insertion into the anorectum may include: