Motility testing diagnostic systems

ManoScan™ AR high resolution manometry system

<p>The ManoScan™ AR high resolution manometry system enables healthcare providers to assess the pressure in the rectum and anal sphincter.</p>

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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 3-D (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 electromagnetic compatibility (EMC) precautions and needs to be installed and serviced according to the EMC documentation of the device.CautionPortable and mobile radiofrequency (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.

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ManoScan™ AR acquisition software

ManoScan™ 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™ AR high resolution manometery system.

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.

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.

ManoScan™ ESO high resolution manometry system

ManoView™ AR analysis software

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

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

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.

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.

ManoScan™ hardware modules

The ManoScan™ HRM modules provide high-resolution and/or 3-D (three dimensional) display of the pressure and impedance data.

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.

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.

ManoShield™ disposable catheter sheath

The ManoShield™ disposable catheter sheath is a latex-free, disposable, catheter protector cover.

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.

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.

ManoScan™ AR high-resolution manometry catheters probe

The high-resolution AR manometry catheter incorporates advanced pressure sensing technology. The ManoScanTM AR 3-D probe features 256 points of measurement generated by 16 axial × 16 circumferential sensors, providing the highest resolution of any available manometry system. And with the 5.6 cm length of continuous circumferential sensing, the ManoScanTM AR 3-D catheter eliminates patient involuntary squeeze artifact and the need for catheter repositioning.

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.

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.