Indications, Safety, and Warnings

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.

Caution

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:

• Only authorized given imaging personnel perform all repairs and modifications.
• The device is only used for the intended use and in accordance with instructions in this documentation.

If these guidelines are violated, the warranty will be invalid.

Contraindications

The use of the ManoScan™ system for pharyngeal/esophageal motility study and proximal gut (gastric/duodenal) manometry is contraindicated for the following:

• Patients with an inability to tolerate nasal intubation.
• Patients with significant bleeding disorders for whom nasal intubation is contraindicated.
• Patients with a known esophageal obstruction preventing passage of the instrument.

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:

• Discomfort, nasal pain, minor bleeding, runny nose, throat discomfort, irregular heartbeat with dizziness, and perforation.
• In rare instances, the catheter may be misdirected into the trachea causing coughing or choking, the catheter may curl during intubation, and catheter position may move during the procedure.

Anorectum insertion

Potential adverse events associated with the use of this system and catheter insertion into the anorectum may include:

• Discomfort, pain, minor bleeding, irregular heartbeat with dizziness, and perforation.
• In rare instances, the catheter may curl during insertion and catheter position may move during the procedure.
• Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.
• The system is not compatible for use in an MRI magnetic field.