MANOSCAN CLT CONVENTIONAL LINE TRACE ......pioneering technology for high-resolution gastrointestinal (GI) manometry used to assess GI motility. Today, it remains the PRVW DGYDQFHG

MANOSCAN™ CLT CONVENTIONAL LINETRACE MANOMETRY SYSTEM

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QUICK GUIDE

WHAT IS THIS?

Introducing the ManoScan™

CLT conventional line trace manometry system from Medtronic. The ManoScan

™ CLT system is the newest

addition to the ManoScan™

Platform, the premier technology for GI manometry worldwide

The ManoScan™

CLT system is the successor of the legacy Polygraf ID™/GastroTrac™ system.

| MSE-7002 ManoScan™ CLT

system upgrade (for existing HRM users and customers not preferring a cart)

Versatility

The ManoScan™

more precise data acquisition.

are included for esophageal, anorectal, antroduodenal, colonic and sphincter of Oddi manometry data.

air-charged and solid-state catheter technology

Ease-of-Use

Manometry procedures are easy to

™ CLT program’s procedure guide feature.

ManoScan™ data acquisition software makes it easier for you to interpret

trace data to an anatomical display for esophageal, anorectal and antroduodenal manometry.

The ManoView™ CLT data analysis software provides semi-automated analysis reducing your need to perform manual steps when studying manometry results.

The Study Manager feature of the ManoView™ CLT software saves you time

All-In-One Upgradeable System

When you’re ready, upgrade to the advanced ManoScan™ HRM system while still keeping the additional

™ CLT system.

To add antroduodenal, colonic and sphincter of Oddi manometry to your existing ManoScan™ HRM

ManoScan™ CLT module and software.

The ManoScan™ platform’s modular design and common user interface ensure that the CLT and HRM modules will integrate seamlessly into a

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WHY MANOSCAN™ SYSTEM? WHY THE MANOSCAN™ CLT SYSTEM?

The ManoScan™ conventional line trace (CLT) manometry system is the newest module of the ManoScan™ platform. It is the successor to the legacy Polygraf ID™/GastroTrac™

and makes operation easier for physicians using conventional line trace manometry.

The physician using the ManoScan™

acquisition and analysis modes for esophageal, anorectal, antroduodenal, colonic and sphincter-of-Oddi manometry. For additional versatility,

charged and solid state catheters.

Physicians will appreciate the intuitive ease of using the ManoScan™ software and semi-automated ManoView™ CLT software. They can count on receiving in-person training, technical service and warranty protection after the sale.

™

A modular upgrade from ManoScan™ CLT system to ManoScan™ HRM system requires only incremental cost. Adding

means simply adding a CLT module. All ManoScan™ modules integrate

The ManoScan™ platform is the pioneering technology for high-resolution gastrointestinal (GI) manometry used to assess GI motility. Today, it remains the

diagnosis of GI functional disorders.

The ManoScan™ platform provides physicians the complete picture of the patient’s GI functionality that they need to make appropriate treatment decisions. They can use the ManoScan™ platform

prevent complication or loss of function and increase the chances for successful surgical interventions. Whatever therapy is required, physicians using the ManoScan™

patient’s GI disorder.

The unique modular design of the ManoScan™ platform also makes it a versatile solution. Physicians can easily modify or upgrade the ManoScan™ manometry system through the seamless addition of other diagnostic modalities, while maintaining one technology platform.

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UPGRADING LEGACY CONVENTIONALMANOMETRY CUSTOMERS

EXPANDING CAPABILITIES OF YOURMANOSCAN™ HRM SYSTEM CUSTOMERS

If your Polygraf ID™/GastroTrac™ system customers prefer to continue performing conventional line trace manometry, sell them the modular,

™ CLT system with or without cart.

existing ManoScan™ HRM system customers ™ CLT (A550)

module and ManoView™ CLT software which

Then, when the time is right, upgrade them to the ManoScan™ HRM system. They’ll keep the ManoScan™ v3.0 software and the workstation as the core of their new HRM system.

adds easily to their system. This will allow them to perform Antroduodenal, Colonic and Sphincter of Oddi manometry.

ManoScan™ HRM Modules

ManoScan™ CLT Module

ManoScan™ CLT ModuleAdd-on ManoScan™ CLT Module

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ULTIMATELY UPGRADING ALLYOUR CUSTOMERS TO MANOSCAN™ HRM SYSTEM

THREE MAIN MESSAGES ABOUTMANOSCAN™ CLT SYSTEM

Your ultimate goal is to upgrade all of your manometry customers

ManoScan™ HRM system.

1 | VERSATILE

The ManoScan™

for more precise data acquisition.

analysis are included for esophageal, anorectal, antroduodenal, colonic and sphincter of Oddi manometry data.

air-charged and solid-state catheter technology.

2 | EASY TO USE

Manometry procedures are easy to perform when you follow the

™ software’s procedure guide feature.

ManoScan™ data acquisition software makes it easier for you to interpret

line trace data to an anatomical display for esophageal, anorectal and antroduodenal manometry.

The ManoView™ CLT data analysis software provides semi-automated analysis reducing your need to perform manual steps when studying manometry results.

The Study Manager feature of the ManoView™ CLT software saves

3 | UPGRADEABLE SYSTEM

When you’re ready, upgrade to the advanced ManoScan™ HRM system while still keeping the additional modalities

™ CLT system.

To add antroduodenal, colonic and Sphincter of Oddi manometry to your existing ManoScan™ HRM

ManoScan™ CLT module and software.

The ManoScan™ platform’s modular design and common user interface ensure that the CLT and HRM modules will integrate seamlessly

that step right now. The modular, all-in-one ManoScan™

needs at a time that’s right for them.

Video Module

Impedance Module

3D HRM Module

Base HRM Module

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POLYGRAF

ID™

/GASTROTRAC™

SYSTEM CUSTOMERS MANOSCAN™

HRM SYSTEM CUSTOMERS

GI PHYSICIANS

Easy to use

ManoView™ CLT software provides semi-automated analysis, reducing need to perform manual steps when

ManoView™ CLT software, which is part of ManoScan™ CLT system, provides

compared to legacy GastroTrac™ software.

ManoView™ CLT software’s Study Manager

NURSES

Easy to use


™ software Guide feature.


New CLT catheter setup window in ManoScan™

to legacy Polygraf ID™/GastroTrac™ system.

ADMINISTRATORS



™ CLT system.

ManoScan™ platform’s modular design and common user interface ensure that CLT and HRM modules will integrate

GI PHYSICIANS

Versatile

Can perform three additional diagnostic modalities (antroduodenal, colonic and sphincter of Oddi) as part of ManoScan™ platform.

Additional features with ManoScan™ software v3.0 such as HIS support and

ManoScan™ CLT system supports HL7 interface to transfer patient data directly to electronic medical records or hospital information systems (HIS)

NURSES

All-In-One System




New CLT catheter setup window in ManoScan™

to legacy Polygraf ID™/GastroTrac™ system.

ADMINISTRATORS



™ CLT system.


Versatile

esophageal, anorectal, antroduodenal, colonic and sphincter-of-Oddi manometry all in one system.

for greater sensing area of anatomy.

Easy modular upgrade to advanced ManoScan™ HRM system in future.

Easy To Use

Similar to HRM, ManoView™ CLT software provides semi-automated analysis, reducing need to perform manual steps


esophageal, anorectal, antroduodenal, colonic and sphincter-of-Oddi manometry

Versatile


and solid state catheter technology.

Easy modular upgrade to advance

Easy To Use

Similar to HRM, manometry procedures

™ software Guide.


and auto-setting of analysis.

Versatile


ManoScan™

with Microsoft Windows 7 and Windows 8 operating systems.

Versatile


ManoScan™

with Microsoft Windows 7 and Windows 8 operating systems.

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NEWMANOMETRY CUSTOMERS

MANOSCAN™ CLT SYSTEM PROMOTIONALMATERIALS FOR YOU TO USE

GI PHYSICIANSEasy To Use

ManoView™ CLT software provides semi automated analysis, reducing need to perform manual steps when

ManoScan™ CLT system makes

data to anatomical display in esophageal, anorectal and antroduodenal modalities.

ManoView™ CLT software’s Study

NURSESEasy To Use



ManoScan™ CLT system supports HL7 interface to transfer patient data directly to electronic medical records or hospital information systems (HIS).

ADMINISTRATORSAll-In-One Upgradeable System

cost to advanced ManoScan™ HRM system.


1 | 1-Page Sell Sheet

2 | “ Complete Solutions for Your Patients” Gastrointestinal Functional Diagnostics Brochure (highlights Medtronic GI’s entire functional diagnostics product portfolio including Bravo™, Digitrapper™, and ManoScan™ systems)

Versatile

channels for more precise sensing.

analysis for esophageal, anorectal, antroduodenal, colonic and sphincter-of-Oddi manometry all in one system.


Versatile



Upgrade to the advanced ManoScan™ HRM system while still keeping the additional

™ CLT system

Versatile

ManoScan™

Windows 8 operating systems

ManoScan™ CLT system supports HL7 interface to transfer patient data directly to electronic medical records or hospital information systems (HIS).

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IMPORTANT PRODUCT FEATURES COMPARISON TO POLYGRAF ID™/GASTROTRAC™ SYSTEM AND MANOSCAN™ HRM SYSTEM

COMPARISON TO COMPETITOR CLT SYSTEMS

MANOSCAN™

Supports water-perfused, air-charged and solid

RoHS compliant USB 2.0/3.0 interface to computer

MANOSCAN™ V3.0 DATA ACQUISITION SOFTWARE

1 | Esophageal (ESO) 2 | Anorectal (AR) 3 | Antroduodenal (ADM) 4 | Colonic (CLN) 5 | Sphincter of Oddi (SOM) Includes Study Manager Imports patient information from HIS Multi-language GUI

MANOVIEW™ CLT V3.0 DATA ANALYSIS SOFTWARE

Includes Study Manager Exports patient information to HIS Multi-language GUI

MANOSCAN™ CART WITH WORKSTATION PORTABLE Holds all system components Built-in isolation transformer 22" touch screen monitor Small form factor PC (Dell 3020 or similar) Laser printer

Features

Supports conventional line trace technology

Operating System supported

Manometry modalities supported

Circumferential pressure sensing, Impedance

Software features like Study Manager, Smart mouse, HIS support

RoHS compliant

Polygraf ID™/ GastroTrac™ System

Yes(Water-perfused, air-

charged, solid state)

Up to 8 CLT channels/sensors channels with 'white'

legacy product)

Win XP

ESO, AR, ADM, CLN, SOM

No

No

No

No

ManoScan™ CLT System

Yes(Water-perfused, air-

charged, solid state)

channels/sensors

Win 7, Win 8

ESO, AR, ADM, CLN, SOM

Yes

No

Yes

Yes

ManoScan™ HRM System

No

sensors

Win 7, Win 8 (ManoView™ ESO/AR soft-

ESO, AR

N/A

Yes

Yes (with ManoScan™

v3.0 software)

Yes

Key Customer Need

Ease of use

ManoScan™ CLT System

Study Manager saves time

Supports HIS export/Import

step acquisition instructions;

Excellent post sale support

ManoScan™ System "look and feel"

ManoScan™ v3.0 Software for HRM & CLT

HRM/CLT integrates on same cart & PC

perfused, air-charged and solid state manometry

from competitors

High

High

Medium

ManoScan™ v3.0 Data Acquisition Software

ManoView™ CLT v3.0 Data Analysis Software

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PRODUCT ORDERING INFORMATION

Stand-alone System++

Upgrade* ++ for ManoScan™ HRM system users

Sales BOM Part Number

MSE-7001

MSE-7002

QTY

1

1

1

1

1

1

1

1

1

1

1

1

1

Contents

FGS-0559 ManoScan™ A550 Manometry Module

FGS-0571 ManoScan™ v3.0 software kit

FGS-0572 ManoView™ CLT v3.0 software kit

FGS-8039 Assy, ManoScan™ Cart

3283 Assy, Modular Cart Accessory kit

FGS-0582 ManoScan™ HRM/CLT WS, Dell 3020 W7

80201 ManoScan™ v3.0 license (virtual item)

80202 ManoView™ CLT v3.0 license (virtual item)

FGS-0559 ManoScan™ A550 Manometry Module

FGS-0571 ManoScan™ v3.0 software kit

FGS-0572 ManoView™ CLT v3.0 software kit

80201 ManoScan™ v3.0 license (virtual item)

80202 ManoView™ CLT v3.0 license (virtual item)

* ManoScan™ WS PC (if required) is purchased separately

and approved disinfectants.

Technology

Solid State

Manometry Modality

Antroduodenal

Colonic

Sphincter of Oddi

Catheter P/N

Custom-ordered

to customer's

K53-74L3-0479D,

Adapter Cables

Multiples of

AD0-0712-00138,

AD7-4712-00551

AD0-0712-00138,

AD7-4712-00551

Misc. Accessories

ZMK-AL01-

MP0148, MSS-

3987

Manufacturer

(formerly Unisensor AG)

Technology

Air-charged (Latitude series)

Manometry Modality

Esophageal

Anorectal

Misc. Accessories

Manufacturer

(formerly Clinical Innovations)

Catheter P/N

GIM-

Technology

Water-perfused

Manometry Modality

Antroduodenal

Colonic

Sphincter of Oddi

Esophageal

Anorectal

Catheter P/N

2270, 2271, 2271, 2273, 2274, 2288

CK-SOM-18-S-LEHMAN-NG

CK-SOM-18-L-LEHMAN-NG

9012P1202, 9012P1212, 9012P1222,

9012P1302, 9012P1322, 9012P1392,

9012P1412, 9012P1422

Adapter Cables

9012C1033,

9012C1053

Misc. Accessories

9012K1013,

9012K1022,

9012K1002

Manufacturer

MediPlus

Cook

Medical

Medtronic

CONTRAINDICATIONS FOR MANOSCAN™ PRODUCT USEThe ManoScan™

(upgrade) to the ManoScan™ HRM system.

RECOMMENDED CATHETERSAir-Charged

RECOMMENDED CATHETERSSolid State

RECOMMENDED CATHETERSWater-Perfused

Adapter Cables

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CONNECTING CATHETER TO A550 MODULE

1 | 2 | 3 | Connect transducer to catheter

1 | 2 |

A550 module

SOLID STATE SYSTEM

1 | 2 |

A550 module

1 1 1

2 2 23

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CALIBRATING SELECTED CATHETER

SOLID STATE TECHNOLOGY

Calibration Steps

1 | 2 | 3 | Make sure gauge reads 0.0 mmHg

4 | 5 | Increase pressure to 100 mmHg

7 | 8 |

Calibration Steps

1 | Move transducer

"open" end

2 | Now move

towards "charge" end

3 | Once charged, sensors will

4 | Insert catheter into

5 | Make sure gauge reads 0.0 mmHg

window

7 | Increase pressure to 100 mmHg

8 |

9 |

10 | successful, press

successful,

Calibration Steps

1 | Start water pump and place catheter in container, making sure water drips through hole in catheter

2 | Keep catheter at 0.0 mmHg scale.

3 | section of the catheter straight and at 0.0mmHg on the scale

4 | Raise and keep catheter at 50.0 mmHg scale

5 |

7 |

1

2

2 1

4

3 5

3

4

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Documents

MANOSCAN CLT CONVENTIONAL LINE TRACE ......pioneering technology for high-resolution gastrointestinal (GI) manometry used to assess GI motility. Today, it remains the PRVW DGYDQFHG