Motility testing diagnostic systems

ManoScan™ ESO high resolution manometry system

<p>The ManoScan™ ESO high resolution manometry system enables healthcare providers to assess the pressure and motor function of a patient’s esophagus.</p>

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Indications, Safety, and WarningsThe material on this website should not be considered the exclusive source of information, it does not replace or supersede information contained in the device manual(s).Please note that the intended use of a product may vary depending on geographical approvals.See the device manual(s) for detailed information regarding the intended use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.For a MRI compatible device(s), consult the MRI information in the device manual(s) before performing a MRI.If a device is eligible for eIFU usage, instructions for use can be found at Medtronic’s website manuals.medtronic.com.Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.Medtronic products placed on European markets comply with EU and UK legislation (if applicable) on medical devices. For any further information, contact your local Medtronic representative.Medtronic medical devices marketed in Spain are in compliance with the Spanish legislation in force.

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ManoScan™ ESO acquisition software

ManoScan™ acquistion software provides the capability of viewing data from all high-resolution sensor channels simultaneously as a contour map in real time, or as line tracings selectable for any location along the sensors.

Software is included with purchase of the ManoScan™ ESO high resolution manometery system.

Indications, Safety, and WarningsIndications for UseThe 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.Warnings and PrecautionsTo 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.CautionPortable 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.ContraindicationsThe 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.Adverse EventsNasal passage insertionPotential 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 insertionPotential 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.

ManoScan™ ESO high resolution manometry system

ManoScan™ ESO analysis software

This software provides necessary tools for detailed analysis of pressure, impedance, and/or video data acquired during ManoScan™ ESO system procedures. The program is intended to provide stand-alone and enhanced functionality relative to the analysis capability incorporated in the ManoScan™ ESO system software.