Motility testing diagnostic systems

ManoScan™ AR high resolution manometry system

<p>The ManoScan™ AR high resolution manometry system allows you to obtain a comprehensive assessment of pressure activity in the rectum and anal sphincter with a single catheter placement.<sup>1</sup></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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Product image of the ManoScan™ ESO high resolution manometry system

ManoScan™ AR acquisition software

Intuitive interface makes it easy to acquire pressure and impedance data points by matching the line trace data to an anatomical display for esophageal, anorectal and antroduodenal manometry.

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.

ManoScan™ ESO high resolution manometry system

ManoView™ AR analysis software

Highly sensitive, intuitive, and easy to use software that decreases interpretation time and enables accurate diagnosis for anorectal disorders.

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™ ESO high resolution manometry module enables seamless acquisition and recording of manometry studies.

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

This single-use, hygienic catheter protector cover is intended to prevent gross contamination and reduce cleaning and disinfecting efforts. The sheaths serve as a disposable protective outer cover that is removed and discarded immediately after the procedure.

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 manometery catheter incorporates advanced pressure sensing technology. The ManoScanTM AR 3D probe features 256 points of measurement generated by 16 axial x 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 3D 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.

Ordering information

Item number	Description	Units per box
2192	ManoScan™ high resolution anorectal catheter	1
2195	ManoScan™ high resolution anorectal pedi catheter	1
3885-3D	ManoScan™ high resolution anorectal 3D catheter	1
FGS-0571	ManoScan™ AR acquisition software	1
FGS-8030	ManoView™ AR analysis software v3.0	1
MSS-3599	ManoShield™ AR disposable catheter sheaths	10
MSS-2155	ManoShield™ disposable catheter sheaths	20
MSS-4360	ManoShield™ AR 3D disposable catheter sheaths	20
MSS-4581-3D	ManoShield™ AR 3D disposable catheter sheaths	10

Resources

European Esophageal Product Family brochure,EMEA-SE-2100161 - 21-weu-esophageal-product-family-brochure-5632155, EMEA‑SE‑2100161-esophageal-product-family-brochure-en-we-8899883

Esophageal product family brochure (open in new window)

View a sales tool brochure for healthcare professionals presenting the esophageal and gastric portfolio with new messages regarding transforming esophageal care and endoscopy.

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