MediGuide™ Technology

MG1000

Software Version 17.1

Instructions for Use

Disclaimer
St. Jude Medical shall not be liable nor obligated in any manner in respect of bodily injury and/or property damage arising from the use of this manual if such
use is not in strict compliance with instructions and safety precautions contained in the relevant operating manuals and in all supplements thereto, in all
product labels, and according to all terms of warranty and sale of this system, nor if any change not authorized by St. Jude Medical is made to the system
contained herein.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the
nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.
Pat. http://patents.sjm.com
© 2016 St. Jude Medical, Inc. All Rights Reserved.
Contents
Preface ...........................................................................................................................................................................1
Symbols..........................................................................................................................................................................2
Definitions Acronyms, and Abbreviations .........................................................................................................................6
Safety .............................................................................................................................................................................7
Conventions ................................................................................................................................................................................. 7
Safety Guidelines ......................................................................................................................................................................... 7
Safety Data .................................................................................................................................................................................. 9
System Description ....................................................................................................................................................... 10
Indications for Use ..................................................................................................................................................................... 10
Contraindications ....................................................................................................................................................................... 10
System Physical Structure .......................................................................................................................................................... 10
System Functionalities ................................................................................................................................................................ 12
System Limitations ..................................................................................................................................................................... 17
System Specifications ................................................................................................................................................................. 17
User Interface and Operating Controls ......................................................................................................................................... 18
Using MediGuide™ Technology .................................................................................................................................... 21
Conventions ............................................................................................................................................................................... 21
System Start-up and Shutdown ................................................................................................................................................... 21
Preparations for a New Procedure............................................................................................................................................... 29
MediGuide™ Technology Key Features ....................................................................................................................................... 42
MediGuide™ Technology Procedure Guidelines .......................................................................................................................... 66
User-Level Maintenance................................................................................................................................................ 75
Maintenance.............................................................................................................................................................................. 75
Data Management...................................................................................................................................................................... 75
Tools Window Description........................................................................................................................................................... 75
Feedback ..................................................................................................................................................................... 78
Safety and Compliance Standards ................................................................................................................................. 79
Electromagnetic Emissions & Immunity ......................................................................................................................... 80
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ........................................................................................ 80
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity ......................................................................................... 80
Preface
This Instructions for Use (IFU) describes the operation of the MediGuide™ System while connected to one or more MediGuide
Enabled™/Sensor Enabled™ device(s).
Prior to use, read this entire document.
This IFU is recyclable. Dispose of all packaging materials as appropriate. Dispose of delivery systems and accessories per standard solid
biohazard waste procedures. St. Jude Medical (SJM) recommends contacting SJM Technical Support before removing this system from
service and disposing of it.

1
Symbols
Symbol Definition

Defibrillation-proof Type CF equipment

Defibrillator-proof type BF applied part

Nonsterile

Do not reuse

Fragile

Keep dry

Temperature limitations

Manufacturer

Date of Manufacture

Use-by date

Lot number

Reorder number

Serial number

Finished good

Consult instructions for use

Consult instructions for use on this website

Do not use if package is damaged

Quantity

Non-ionizing radiation

This End Up

Dispose of hardware in accordance with local law

CAUTION: Federal law (U.S.) restricts this device to sale by or on the order of
a physician.

2
Notified Body Mark

Authorized Representative in the European Community

Caution

Warning

Flammable

X-ray radiation

Explosion Hazard

Electrical Shock Hazard

Dangerous Voltage

Voltage Hazard Sign

ON/OFF button

AC Power

Internal functional earth terminal

Earth (ground)

Earth (ground)

Software version

FUSE, 5 x 20 mm, 10A, 250V, High Breaking Capacity

ETL Listed
Conforms to
UL STD 60601-1
IEC STD 60601-1
Certified to CAN/CSA STD C22.2 NO.601.1

Application PC

Cable

Cable Kit

3
Cable Tester Kit

Cart

CAS Kit (C-Arm Sensor Kit)

Cath Connect

Cath Connect Bracket

Cath Connect Holder

Cath Connect Kit

Connect

Cover Proximity Switch

Cover Proximity Switch

CPS Component

Display

ECG (Electrocardiogram)

ECG Cable

ECG Kit

Floor Mount

Fuse

Keyboard

Large Detector

Large Detector Upgrade Kit

Magnetic Transmitter Assembly

MPS Control Application

Medical Electrical Equipment

Mouse

MediGuide™ System Console

Magnetic Transmitter Assembly Control

MTAC (Magnetic Transmitter Assembly Control)

MTAC Cable Adaptor

MTAC Polarization Cable

Patient Reference Sensor

Power Control

4
Power Splitter

Power Supply

PRS Patch

Rear Mount

Real Time Unit

Software Installation

Software Media

Software upgrade kit

System

System Installation Tool

Technology

Table Side Unit

Upgrade Kit

VC21

VC21 Compatible System

VD10 Compatible System

Workstation

XIU (X-Ray Interface Unit)

Fluoroscopy Interface Unit

5
Definitions Acronyms, and Abbreviations
Table 1. Definitions, Acronyms, and Abbreviations

Cine A recorded fluoroscopy sequence used for playback

CRT Cardiac Resynchronization Therapy
CS Coronary Sinus
MediGuide™ Connect Electronic Box
DICOM Digital Imaging and Communications in Medicine
ECG Electrocardiogram
EMI Electromagnetic Interference
EP Electrophysiology
FD Fluoroscopy system’s flat detector
fps Frames per second
GUI Graphical User Interface
Master Power Switch Switch located on the bottom left corner of the MediGuide™ System Console. This switch shuts off power
to all MediGuide™ System components, both inside and outside the MediGuide™ System Console.
MediGuide™ Cath Connect Interconnection Box
ICD Implantable Cardioverter Defibrillator
IVC Inferior Vena Cava
LA Left Atrium, Left Atrial
LV Left Ventricle, Left Ventricular
MB Motion Box
MPSC MediGuide™ System Console
MTA Magnetic Transmitter Assembly
Os, OS Ostium
P&O Position and Orientation
PACS Picture Archiving and Communication System
Power Switch Switch located on the Table Side Unit, controlling ON/OFF of the MediGuide™ System.
pps Pulses per second
MediGuide™ Patient Patient Reference Sensor/Motion Sensor; herein referred to as PRS
Reference Sensor (PRS)
RA Right Atrium, Right Atrial
RAM Random Access Memory
Ref Reference
ROI Region of Interest
RV Right Ventricle, Right Ventricular
SVC Superior Vena Cava
SID Source to Image Distance
SCP Filter Semi-Constant PRS Filter
System The combined hardware and software comprising the MediGuide™ Technology
System Circuit Breaker A circuit breaker switch that allows disconnecting MAINS to the MediGuide™ System. This switch is
external to the MPSC or any other MediGuide™ System component.
TSU Table Side Unit
XIU Fluoroscopy Interface Unit

6
Safety
Conventions
The safety instructions in this IFU are used for the protection of the patient, Healthcare personnel, and service personnel. These
instructions identify hazards that might occur if instructions are ignored or not followed correctly. The identified hazards are defined and
classified as follows:
WARNING: WARNING indicates that PERSONAL INJURY OR DEATH might occur to the patient and/or user if the user
does not observe the provided information.
CAUTION: CAUTION indicates that DAMAGE TO EQUIPMENT might occur if the user does not observe the provided
information.
NOTE: NOTE indicates that the USER MAY BE INCONVENIENCED and subsequent problems may result if the user does not
observe and follow the provided information.

Safety Guidelines
 Before use, carefully read this IFU and the precautionary information and follow the instructions in this IFU while using the system.
 This product was designed and manufactured to ensure maximum safety of operation. It should be operated and maintained in strict
compliance with the safety precautions, warnings, and operating instructions contained herein.
 This product should be operated only by qualified personnel after completing the St. Jude Medical training. Inappropriate use of the
MediGuide™ System may lead to inaccurate information presented to the clinician, which may lead to patient injury.
 Unauthorized personnel should not be allowed access to the system.
 There are no user serviceable parts in this system. The product should be installed, maintained, and serviced by qualified service
personnel authorized by St. Jude Medical.
 The system in whole or in part should only be modified by St. Jude Medical authorized personnel.
 The MediGuide™ System must be operated by, or under the supervision of, a medical professional specifically trained in the
operation of the MediGuide™ System supported by other qualified personnel trained in the field of cardiac electrophysiology (EP).
 If the product does not operate properly or if it fails to respond to the controls as described in this IFU, the operator should:
- First ensure the safety of the patient and then the safety of the equipment
- Follow the safety precautions as specified in this IFU
- Perform system shutdown
- Immediately contact a St. Jude Medical representative, report the incident, and await further instructions.
 The MediGuide™ System can be used with single use, disposable sterile covers for the following elements: Table Side Unit (TSU)
and Magnetic Transmitters Assembly (MTA).
These items might be contaminated and must be handled properly. The proper disposal of the sterile covers should be done
according to the common practice of the specific Catheterization Laboratory (Cath Lab), together with the other Cath Lab disposable
equipment.
 Introduction of any MediGuide Enabled™/Sensor Enabled™ device should be used only for suitable patients as specified in the
device's Instructions for Use.
 The images/calculations provided by this system are intended as tools for the qualified user. They are explicitly not to be regarded as
a sole incontrovertible basis for clinical diagnosis.

ELECTRICAL SHOCK
HAZARD:
Do not remove or open system covers or plugs. Internal circuits use high voltage capable of causing serious
injury.

ELECTRICAL
HAZARD: An electrical hazard might exist if any light, display or visual indicator stays on after the system is turned off. To
prevent possible injury, turn the switch in the mains power supply box off, and contact your service office
immediately.

 Fuses blown immediately after being replaced may indicate malfunctioning electrical circuits within the system. Do not continue
replacing a fuse if it blows immediately after replacing it. Have the system checked by St. Jude Medical's qualified service personnel,
and do not continue to replace the same fuse.

7
 FLAMMABLE:
Conductive fluids that come in contact with any active circuit components of the system might cause short
circuits that can result in electrical fires. Do not allow liquids to contact any part of the system

 To avoid electrical shocks or burns caused by the use of the wrong type of fire extinguisher, make sure your fire extinguisher has
been approved for use on electrical fires.

EXPLOSION HAZARD: Do not operate the equipment in the presence of explosive liquids, vapors or gases. Do not plug in or turn the
system on, if hazardous substances are detected in the environment. If these substances are detected after the
system has been turned on, do not attempt to turn off or unplug the unit. Evacuate and ventilate the area before
turning the system off.

 There are possible explosion hazards if the system is used in the presence of flammable anesthetics.
 Overheating - DO NOT block the ventilation ports of the electronic equipment. Always maintain at least 12 cm (5 inches) clearance
around the ventilation ports to prevent overheating and damage to the electronic hardware.
 If the temperature in the MTA exceeds 70°C (158°F), the system will stop tracking and a corresponding warning will be displayed on
the MediGuide™ System display.
 Patients and Cath Lab employees with an implanted device other than the devices listed below should not enter the room while the
system is Powered ON.
The following devices are safe for use with MediGuide™ Technology:
- St. Jude Medical Atlas™ II Cardiac Resynchronization Therapy (CRT) device
- St. Jude Medical Affinity™ DR Pacemaker
- St. Jude Medical Identity™ Pacemaker
- St. Jude Medical Victory™ Pacemaker
- St. Jude Medical Current™ DR RF Implantable Cardioverter Defibrillator (ICD)
- Medtronic EnPulse 1 E2SR01 Pacemaker
- Medtronic Marquis 2 VR 7230Cx ICD
 Patients with any implantable device might undergo a MediGuide™ Technology procedure provided that the implantable device
complies with ANSI/ AAMI PC69 and the implantable device manufacturer's recommendations regarding the type of invasive
procedure and exposure to electromagnetic interference (EMI) are strictly followed. In addition, it is recommended to turn off the
magnetic field of the system (refer to the figure, Turn Magnet OFF button (page 24) and the note preceding it) during telemetry or
communication between an external programmer and the implanted device.
WARNING: In any case of abnormal behavior of the implanted device, turn the system's magnetic field off (refer to the
figure, Turn Magnet OFF button (page 24) and the note preceding it).
WARNING: Whenever device programming has been performed before or during the procedure, it is recommended,
following the procedure, to:
- Program the device back to its original pre-procedure settings or other settings according to the patient's clinical indications.
- Perform a routine device evaluation.
NOTE: In any case of uncertainty regarding device programming, please consult with a relevant device expert
 While the MediGuide™ System is being powered ON, it is recommended to keep a minimum distance of 5 cm (2 in) from the MTA
that is positioned on the Fluoroscopy system's Flat Detector. However, a momentary approach to the Fluoroscopy system's Flat
Detector is acceptable.
 Any changes in the Cath Lab configuration should be communicated to St. Jude Medical Technical Support.

X-RAY RADIATION:
It is required to follow your facility's internal Radiation Safety Practices.

WARNING: An X-ray hazard is present during live fluoroscopy.

 Before starting the first MediGuide™ Technology procedure, perform the daily tests specified in Using MediGuide™ Technology
(page 21).

1
EnPulse is a trademark of Medtronic.
2
Marquis is a trademark of Medtronic.

8
 The system continuously monitors its operation and displays status information on the MediGuide™ System display. In case of
malfunction, a corresponding warning appears on the display. Carefully watch the MediGuide™ System display for status
information and warnings, and proceed correspondingly.
 DO NOT bring items containing metallic elements closer than 20 cm (8 inches) to the transmitters. Contact a St. Jude Medical
authorized technician when introducing new/untested devices containing metallic elements into the Cath Lab that are intended to
stand in vicinity to MediGuide™ Technology.
 The additional monitors in the control room (where applicable) should be powered from the system's isolation-transformer output.
 Do not place the Patient Reference Sensor (PRS) patch on skin sites with established erythema, lesions, and injuries of any kind nor
use it on patients with shown skin irritating effects upon direct PRS patch contact.
 Do not operate the system in a room where air conditioning is not available. Full performance of the system is guaranteed only when
ambient temperature is 15°–27°C (59°–80.6°F).
 In case of emergency or to turn mains power off to the MediGuide™ System, switch off the System Circuit Breaker, typically located
next to the MPSC, or near the Cath Lab breaker switch.
NOTE: The System Circuit Breaker shall not be used to shut down the MediGuide™ System in normal operation. Refer to
System Shutdown (page 28) for normal shutdown procedure.
NOTE: Ensure the patient is a minimum distance of 8 cm (3 inches) from the patient table to avoid magnetic interference from
the Cath Lab table. A MediGuide™ Technology compatible mattress should always be sourced from Siemens AG and used with
MediGuide™ Technology.
MediGuide™ Technology is approved for use with the following Siemens Artis™ tabletop mattresses depending on the tabletop
width:
- Thick Mattress for Tabletop Wide, MediGuide™ Technology compatible
- Thick Mattress for Tabletop Narrow, MediGuide™ Technology compatible
CAUTION: The filter plate within the Siemens Flat Detector assembly must remain within its housing while using
MediGuide™ Technology. Removal of this filter plate may impact the accuracy of the system.
CAUTION: The input/output ports of the MPSC cabinet are intended only to be used with MediGuide™ compatible
equipment. Using the ports with incompatible equipment might result in system damage. Do not connect any externally
powered devices (e.g. monitors) to any accessible ports within the MediGuide™ System.
WARNING: Within the MediGuide™ Technology coordinate system, proper registration is dependent on correct
identification and placement of fiducials on anatomical locations within the 2 dimensional X-Ray image and 3
dimensional CT model. The CT model represents a previously acquired anatomy and may not correspond to the X-Ray
image. Do not use the registered surface model as the means of navigation. Confirm catheter position relative to the
anatomy using conventional means (e.g., fluoroscopy, intracardiac echocardiography).

Safety Data
1. BEFORE starting a new MediGuide™ Technology procedure, verify that correct patient identification information has been entered
as instructed in this IFU. The MediGuide™ Technology application allocates a unique procedure ID to each procedure
2. The Clinical Screen includes an indicator of remaining disk space at the bottom. Refer to Data Management (page 75) for more
details regarding handling low disk space. To free hard disk space, either export or delete patient studies.

9
System Description
Indications for Use
The MediGuide™ Technology system is intended for the evaluation of vascular and cardiac anatomy. It is intended to enable real time tip
positioning and navigation of a MediGuide Enabled™/Sensor Enabled™ (equipped with a magnetic sensor) invasive device used in
vascular or cardiac interventions in the Cath Lab environment, on both live fluoroscopy or recorded background. The System is indicated
for use as an adjunct to fluoroscopy.

Contraindications
There are no known contraindications.

System Physical Structure

MediGuide™ Technology
MediGuide™ Technology consists of the following hardware units:

Figure 1. Room Layout of MediGuide™ Technology

1. Magnetic Transmitter Assembly (MTA)

2. MediGuide™ Cath Connect, Sensor
Enabled™
3. MediGuide™ Cath Connect
4. MediGuide™ Connect
5. Table Side Unit (TSU)
6. MediGuide™ Displays
7. MediGuide™ ECG patches, Patient
Reference Sensor (PRS), and PRS
Patch

Description of Layout
 MediGuide™ System Console (MPSC) - system computing and communication units.
CAUTION: In order to assure adequate system performance, verify that the MPSC ventilation openings are not blocked.
Blocking the MPSC ventilation may result in system overheating and shutdown. Additionally, do not place any liquids or
powders in the vicinity of the MPSC ventilation vents.
 MTA - assembled on the Fluoroscopy system’s Flat Detector. It generates a controlled magnetic field around the patient's chest.
 MediGuide™ Cath Connect - an electronic interface between the MediGuide™ Connect and MediGuide Enabled™ devices. The
MediGuide™ Cath Connect itself is placed on the patient table or on the provided bed rail mount. When in use, MediGuide
Enabled™ devices are connected to the MediGuide™ Cath Connect.
 MediGuide™ Cath Connect, Sensor Enabled™ - an electronic interface between the MediGuide™ Connect and Sensor Enabled™
devices. The MediGuide™ Cath Connect, Sensor Enabled™ itself is placed on the patient table, next to the MediGuide™ Cath
Connect or on the provided bed rail mount. When in use, Sensor Enabled™ devices are connected to the MediGuide™ Cath
Connect, Sensor Enabled™.
CAUTION: All table side units, especially the MediGuide™ Cath Connect and the MediGuide™ Cath Connect, Sensor
Enabled™, should be situated at least 70 cm (28 in) away from the MTA. Placing the units in close vicinity to the MTA
might lead to inaccurate tracking.
NOTE: Between procedures, the MediGuide™ Cath Connect and the MediGuide™ Cath Connect, Sensor Enabled™ should be
stored in a non-obstructive location on the patient table rail to avoid disturbance to other operations.

10
 MediGuide™ Connect - used to connect the MediGuide™ Patient Reference Sensor (PRS), the MediGuide™ Cath Connect, the
MediGuide™ Cath Connect, Sensor Enabled™, and the ECG cable to the Console. The MediGuide™ Connect is either mounted on
the patient table rails, or installed beneath the patient table in an area not to impede the movement of the patient table.
 TSU - a standard mouse and slide surface through which the user operates the system. The TSU is attached to the patient table
rails. In addition, the power switch of the system is located on the TSU.
CAUTION: To avoid damage and possible malfunction of the units attached to the patient table (MediGuide™
Connect/MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™/TSU), do not place any liquid in
their vicinity. In order to avoid system over-heating, it is important to verify that all units attached to the patient table
(MediGuide™ Connect/MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™/TSU) have proper
heat convection (meaning units are in open space and not covered) at all times.

NOTE: All cables of the units attached to the patient table (MediGuide™ Connect/MediGuide™ Cath Connect/MediGuide™
Cath Connect, Sensor Enabled™/TSU) should be handled with care in order to prevent cable functionality problems.
 MediGuide™ Display - MediGuide™ Technology output is displayed in the Cath Lab and is also displayed on the Technician
Interface Station, typically in the control room. The output display includes the fluoroscopy acquired images as well as the
superimposed MediGuide™ Technology visualization information (e.g., device tracking and landmark positioning), and it covers two
screens. The left screen, named the Primary Display, displays superimposed device projections and landmarks onto 2D X-ray
images, either live (currently acquired) or previously recorded, according to the projection direction of each image. In addition, the
system controls reside on the Primary Display. The right screen, named the Secondary Display, displays by default an interactive 3D
display of the tracked MediGuide Enabled™/Sensor Enabled™ devices and 3D overlays (landmarks, lesions, registered surface
models, catheter shaft renderings, and Angio Survey™ 3D models). This interactive view can be freely rotated, panned, or zoomed
in/out by the user, since it is not projected on fluoroscopy where the viewing angle is dictated. The second monitor can also display
fluoroscopic acquired images, as well as the superimposed MediGuide™ Technology visualization information (e.g., device tracking
and landmark positioning). The MediGuide™ System is supplied with two monitors to be installed in the control room, while the Cath
Lab display is executed by a St. Jude Medical technician in accordance with the configuration of each Cath Lab. Two Cath Lab
display options are currently enabled:
- Two commercially available high resolution color monitors dedicated to the MediGuide™ System output display.
- A large display that emulates several monitors and can dedicate two monitors to the MediGuide™ Technology output. In both
options the monitors should comply with the MediGuide™ Technology specifications for display and monitor.
CAUTION: Monitors should be situated at least 70 cm (28 in) away from the MTA to avoid potential interference.
 PRS - the Patient Reference Sensor is used to compensate the calculated positioning of the MediGuide Enabled™/Sensor
Enabled™ device during patient motions and to sense respiration motion. The proximal end of the PRS (its connector), is connected
to the MediGuide™ Connect, while its distal end (the sensor) is externally attached to the patient chest at a predefined position via
the PRS Patch.
 MediGuide™ System ECG - a dedicated 3-lead ECG signal display used to synchronize between all signals (the fluoroscopy
acquired images, the position and orientation (P&O) signal, and MediGuide™ Technology generated 3D objects) and the patient
cardiac cycle. The ECG cable is connected to the MediGuide™ Connect and the 3 ECG cables are attached to the patient's chest at
predefined locations via off-the-shelf ECG electrodes.
CAUTION: The MediGuide™ System ECG is not intended for patient monitoring.

NOTE: The ECG signal is not to be used as the primary/sole patient monitor during an Electrophysiology study.
 Technician Interface Station - located in the Cath Lab control room. It includes two monitors, which mirror the display on the table-
side monitors, a keyboard, and a mouse. The Technician Interface Station is used for typing in alpha-numeric patient data, clinical
system operation, and maintenance purposes such as archiving and deleting study data.
 MediGuide Enabled™/Sensor Enabled™ device - a single-use, sterilized device with a magnetic sensor. The proximal end of the
device (its connector) is connected to the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™ (up to 3
devices simultaneously in each respective MediGuide™ Cath Connect device).

MediGuide Enabled™/Sensor Enabled™ Devices

MediGuide Enabled™/Sensor Enabled™ devices are equipped with a miniaturized magnetic localization sensor. This tracks P&O of the
device.
The magnetic sensors are electrically connected through electric cables threaded along the device body, extended proximally to the hub
and terminated by electric connectors to be connected to the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™.
When located in the Motion Box (MB, a volume around the relevant anatomical structure of the patient where MediGuide™ Technology
generates a low intensity magnetic field) during system operation, electrical voltage is induced on the magnetic sensor, which is measured
by the MPSC via the electric cable and connector to the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™, for
the calculation of the sensor's P&O.

11
System Functionalities
Overview
MediGuide™ Technology consists of hardware and software elements, which are installed in conjunction with the existing fluoroscopy
Imaging System in a Cath Lab. The conventional fluoroscopy Imaging System, equipped with MediGuide™ Technology elements,
continues to perform safely and effectively per its intended use as fluoroscopic imaging while enabling device tracking and enhanced
visualization tools supplied by MediGuide™ Technology capabilities.
The navigation/tracking data is acquired by MediGuide Enabled™/Sensor Enabled™ devices, which are invasive devices equipped with
miniaturized magnetic localization sensors. The sensor's real time three-dimensional position and orientation are calculated and displayed
to the user when located in a controlled, low intensity magnetic field (less than 200 µTesla nominal value).
MediGuide™ Technology, in conjunction with conventional fluoroscopy, is then intended to provide the following capabilities:
 Tracking the position and orientation of MediGuide Enabled™/Sensor Enabled™ devices that are within the MB, a volume around
the relevant anatomical structure of the patient, where the system generates a low intensity magnetic field. The system can track up
to six devices simultaneously (three in the MediGuide™ Cath Connect and three in the MediGuide™ Cath Connect, Sensor
Enabled™).
 Continuously displaying the MediGuide Enabled™/Sensor Enabled™ device position superimposed on live fluoroscopy images
 Continuously displaying the MediGuide Enabled™/Sensor Enabled™ device position on ECG synchronized playback of pre-
recorded fluoroscopy
 Allowing landmark assignment of points of interest in the inspected anatomy and displaying these landmarks on live and pre-
recorded fluoroscopy and cine playback

Magnetic System’s Positioning and Navigation Principle

The principle of MediGuide™ Technology positioning and navigation, in conjunction with a MediGuide Enabled™/Sensor Enabled™
device, is based on capturing and processing the signals received from a P&O sensor upon the activation of a controlled low AC magnetic
field (less than 200 µTesla nominal value). The MTA generates the magnetic field around the relevant patient's anatomical structure in a
defined 3D space, named the Motion Box.
NOTE: Because the MTA emits a magnetic field, it is recommended to keep at least 15 cm (6 in) away from the MTA while the
system is being operated.
When a magnetic sensor is located in the MB, it senses the magnetic field and the system can calculate its real time position and
orientation. The position and orientation of each sensor is expressed as the position (X, Y and Z axis) and orientation (Azimuth, Elevation,
and in some sensors, Roll) of the P&O sensor relative to the transmitters. This concept is illustrated in the next figure.
MediGuide™ Technology tracks the position and orientation (P&O) of MediGuide Enabled™/Sensor Enabled™ devices to within 1 mm
and 5 degrees.
WARNING: When a sensor moves outside the MB or a sensor is not located by the system, its calculated position and
orientation is unknown and the operator is notified.

Figure 2. Magnetic tracking system concept

1. MediGuide™ Technology
2. MTA
3. Motion Box
4. P&O Sensor

Projection on Live Fluoroscopy

MediGuide™ Technology tracks any MediGuide Enabled™/Sensor Enabled™ device on live fluoroscopy images. This feature is facilitated
by the calibration between the MB volume and the fluoroscopy images. As a result, the P&O of any tracked magnetic sensor can be
projected on live fluoroscopy. Depending on the context, P&O, or just the position of the device is displayed.

12
Tracking on Images Acquired from Different Angulations
In addition to the sensor, the system uses the PRS for correlation of the patient's position and orientation relative to the transmitters. As a
result, the current P&O of any MediGuide Enabled™/Sensor Enabled™ device can be projected on a previous X-ray image, even if taken
from different C-Arm angulations. The transformation between the current and previous angulations of the C-Arm is performed using the
PRS’s P&O as a known location in space or fiducial marker.

Motion Compensation
MediGuide™ Technology includes a motion compensation function, handling the following motion components:
 Motion of the patient with respect to the Fluoroscopy system’s Flat Detector, motion of the C-Arm, the patient table, or the patient's
body.
- This compensation is performed by using the position and orientation of the PRS positioned on the relevant part of the patient's
body and correlates between the patient and MediGuide™ transmitters. The system maintains the registration of the
MediGuide™ System to fluoroscopy.
 Motion of the patient's heart with respect to the patient's body due to the cardiac motion.
- This compensation is performed by correlation of the motion of a MediGuide Enabled™/Sensor Enabled™ device with real time
cardiac phase computed from the ECG signal.
 Motion of the patient's heart due to respiration.
- This compensation is performed by correlation of the motion of a MediGuide Enabled™/Sensor Enabled™ device with a
respiration signal computed from the motion of the PRS. The respiratory compensation is also cross-correlated with the cardiac
compensation, due to the complex relationships between these two motion components.

Tracking on Previously Acquired Fluoroscopy Images

The combined effect of the principles and features described in the sections Overview (page 12) through Motion Compensation (page 13)
is the ability of MediGuide™ Technology to track a MediGuide Enabled™/Sensor Enabled™ device on previously acquired fluoroscopic
images. To project the current P&O of a MediGuide Enabled™/Sensor Enabled™ device on a previously acquired image, the system
computes the required compensation function between current P&O (with the current cardiac phase, current respiration status, and
current patient position relative to the Fluoroscopy system’s Flat Detector) and the position and orientation of the volume surrounding the
device at the time when the selected fluoroscopy image was acquired (with its corresponding cardiac phase, respiration status, and
patient position relative to the Fluoroscopy system’s Flat Detector).
MediGuide™ Technology enables real time tracking of a MediGuide Enabled™/Sensor Enabled™ device on previously acquired
fluoroscopy images. A common mode of operation can use a previously acquired cine as a road map on which the MediGuide
Enabled™/Sensor Enabled™ devices are tracked, in addition to using live fluoroscopy at the operator's discretion.

Landmarks
MediGuide™ Technology enables the operator to place and visualize landmarks based on a magnetic sensor's position and orientation
data. The landmarks, once placed by the operator, can be tracked on live and previously acquired fluoroscopy images, similar to
MediGuide Enabled™/Sensor Enabled™ device tracking. Custom landmarks may also be placed, if previously defined in a Landmark
Preset (refer to the section, Landmarks Presets (page 41)). The following landmarks can be assigned:

Table 2. Landmarks

Landmark Acronym Graphic

Inferior Vena Cava IVC

Superior Vena Cava SVC

Coronary Sinus Ostium CS OS

Coronary Sinus Parking Position CS Park

Coronary Sinus Reference CS Ref

Fossa Ovalis Ostium OS

13
Tricuspid Valve TCV

Right Ventricular Outflow Tract RVOT

Right Atrial Appendage RAA

Right Inferior Pulmonary Vein Ostium RIPV

Right Superior Pulmonary Vein Ostium RSPV

Left Inferior Pulmonary Vein Ostium LIPV

Left Superior Pulmonary Vein Ostium LSPV

Apex Apex

Lesion Lesion

Catheter Shaft Rendering

NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application.
MediGuide™ Technology features an option to display an approximation of the shaft of a MediGuide Enabled™/Sensor Enabled™ device
(for example, outer guide catheter). The approximated shaft is displayed between a pre-defined SVC landmark and the tip of the
MediGuide Enabled™/Sensor Enabled™ device, as seen in the next figure. The purpose is to demonstrate how the device's shaft
behaves, in addition to the tip, which is tracked by the system. This may be useful, for example, when an outer guide catheter is
manipulated in the right atrium during Coronary Sinus (CS) cannulation. It should be noted that the rendered shaft is only an
approximation, and not necessarily an accurate representation of the catheter. The shaft rendering can be turned off at any time.

Figure 3. Shaft Rendering

14
Angio Survey™ 2D Fusion
NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application
MediGuide™ Technology features an option to display live fluoroscopy with a fused overlay of any previously recorded acquired
fluoroscopy loop, as seen in the next figure. The purpose of this feature is to display previously imaged anatomy (e.g., an angiogram of the
anatomy) in a synchronized way while the operator uses live fluoroscopy to view the device and associated MediGuide Enabled™/Sensor
Enabled™ and non-MediGuide Enabled™/Sensor Enabled™ tools. This enables the operator to visualize the tools and devices with
respect to the anatomy.

Figure 4. Angio Survey™ 2D Fusion

1. Venogram overlay
2. Lead tip under live fluoroscopy
3. MediGuide Enabled™/Sensor Enabled™ device tips

Angio Survey™ 3D
NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application
MediGuide™ Technology features a capability to reconstruct a 3D model of a vascular anatomical structure from two cines where contrast
agent is used, recorded at different projections. The reconstructed model can be displayed in 3D and projected on live and pre-recorded
fluoroscopy, as seen in the next figure.

Figure 5. Angio Survey™ 3D

15
Angio Survey 2D ROI
NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application
The 2D ROI may be used to identify the path of the vessel on a selected venogram in order to optimize MediGuide Enabled™/Sensor
Enabled™ tool projection on the venogram, as seen in the next figure.

Figure 6. Angio Survey™ 2D ROI

Surface Modality Registration

MediGuide™ Technology is capable of fiducial-based registration using DICOM 3-formatted CT/MRI/Dyna CT surface files, imported from a
USB device, CD/DVD, a network drive, an EnSite™ Cardiac Mapping System or a hospital PACS server. The surface model can then be
displayed in 3D or be projected on fluoroscopy, live or pre-recorded, as shown in the next figure.

Figure 7. Surface Modality Registration

3
DICOM is a trademark of the National Electrical Manufacturers Association.

16
System Limitations
Due to the MediGuide™ Technology magnetic field characteristics, the following limitations apply to operation of the fluoroscopy system
during MediGuide™ Technology procedures:
 Fluoroscopy system’s Flat Detector up/down movement is limited to an SID range of 90 cm–115 cm, due to magnetic interference of
the Fluoroscopy system’s Flat Detector metal base
 The distance between the Fluoroscopy system’s Flat Detector and the patient's body should not exceed 15 cm (6 in), due to MB
dimensions
The MediGuide Enabled™ C-Arm rotation angle from home position is limited as follows:
 LAO-RAO axis to ±60°
 CAU-CRA axis to ±45°
 Rotation angle axis to ±6°

MediGuide™ Technology Compatible Fluoroscopy Systems

MediGuide™ Technology is designed to work in conjunction with a fluoroscopy system. Currently, MediGuide™ Technology is compatible
to work with the following fluoroscopy systems, under detailed limitations.
MediGuide™ Technology works in combination with the following fluoroscopy systems:
 Siemens AXIOM Artis 4 dFC and dBC (VB35) Small Flat Detector (20 x 20 cm)
 Siemens Artis Zee 5 (VC14) Small Flat Detector (20 x 20 cm)
 Siemens Artis Zee dFC and dBC* (VC21) Small Flat Detector (20 x 20 cm) and Large Flat Detector (30 x 40 cm)
 Siemens Artis Q.zen 6 dFC and dBC* (VD10) Mid-Size Flat Detector (26 cm x 30 cm)
 Siemens Artis Q™ 7 dFC and dBC* (VD10) Small Flat Detector (20 x 20 cm) and Large Flat Detector (30 x 40 cm)
 Siemens Artis Zee dFC and dBC* (VD11) Small Flat Detector (20 x 20 cm) and Large Flat Detector (30 x 40 cm)
 Siemens Artis Q.zen dFC and dBC* (VD11) Mid-Size Flat Detector (26 cm x 30 cm)
 Siemens Artis Q dFC and dBC* (VD11) Small Flat Detector (20 x 20 cm) and Large Flat Detector (30 x 40 cm)
NOTE: For all the supported bi-plane (dBC) systems the support is for plane A (floor mounted C-arm) and only if plane B is in
parking position.
MediGuide™ Technology works with the above fluoroscopy systems under the following limitations:
 Siemens System Frame Rate: Fluoro - 2-30 pps (pulses per second); Angio/Cine - 2-30 fps (frames per second)
 Source to image distance: 90-115 cm
 MediGuide™ Technology is automatically synchronized to the fluoroscopy system’s Flat Detector Zoom.
 Fluoroscopy exam set is assigned to a dedicated gMPS exam set with supported features. For all other fluoroscopy system exam sets
and any non-supported features selected, MediGuide™ Technology is disabled.
 Bi-plane mode is not supported. Whenever plane B is moved from the parked position the system stops transmissions, and resumes
functionality when plane B is repositioned to the parked position.
 Small Flat Detector (20 x 20 cm)
 Mid-Size Flat Detector (26 x 30 cm)
 Large Flat Detector (30 x 40 cm)
CAUTION: The filter plate within the Siemens Flat Detector assembly must remain within its housing while using
MediGuide™ Technology. Removal of this filter plate may impact the accuracy of the system.

MediGuide™ Technology Interference with Other Systems

Before placing a new system/device near a MediGuide™ Technology device, contact a St. Jude Medical authorized technician to find out
if any magnetic interference is known to occur.
If any interference is suspected to be MediGuide™ System related, turn the magnets off and verify that the interference disappears. If it
does, contact St. Jude Medical Technical Support to explore options for eliminating the interference.

System Specifications
This section provides the electrical, magnetic, display, physical, and environmental specifications of MediGuide™ Technology. For the
specifications of a particular MediGuide Enabled™/Sensor Enabled™ device, refer to the IFU packaged with the device.

Table 3. System Specifications

Type Parameter Value

Input Power 100-240 V AC 50-60 Hz
Electrical Max Input Current 8 A @ 110 V AC
4 A @ 240 V AC

4
AXIOM and Artis are trademarks of Siemens.
5
ARTIS ZEE is a trademark of Siemens.
6
ARTIS Q.ZEN is a trademark of Siemens.
7
ARTIS Q is a trademark of Siemens.

17
Table 3. System Specifications

Type Parameter Value

Max Power Consumption 1kW
Patient Isolation The unit is classified as Class I system continuously
operated, ordinary equipment with type BF and CF applied
parts. Patient leakage current is limited to the levels
specified in IEC-EN-UL 60601-1, 60601-1-1
Nominal Patient Magnetic Field Flux <200 µT @ audio frequency
Nominal Personnel Magnetic Field Flux <10 µT @ audio frequencies
Magnetic Field
Minimal MB Dimensions 340 mm x 280 mm x 200 mm
(W x H x D)
Patient Electric Field <420 V/m @ audio frequencies
Electric Field
Personnel Electric Field <30 V/m max @ audio frequencies
Physical Display Resolution 1280 x 1024
Dimensions 80 cm x 199 cm x 44 cm
Console (W x H x D)
Weight 200 kg max
Dimensions 19 inches
Monitor (each)
Weight 15 lbs. (6 kg)
Environmental conditions Ambient Temperature -13°F – +158°F (-25°C – +70°C)
(transport and storage) Relative Humidity 15%–95%
Environmental conditions Ambient Temperature +59°F – +80.6°F (+15°C – +27°C)
(operations) Relative Humidity 20%–75%

User Interface and Operating Controls

The following sections describe the system operation using the software's Graphic User Interface (GUI) and hardware operating controls.

Operating Controls
MediGuide™ Technology is operated via a GUI and Physical Controls.
Application Controls/Software User Interface Components
 The GUI appears on two system monitors. The Primary Monitor (on the left) displays the live fluoroscopy images and cines. The
Secondary Monitor (on the right) displays status information and MediGuide™ Technology objects in a 3D space or a dual cine view,
if selected by the user. The GUI consists of display windows, menus, buttons, and slider bar controls. In addition, it displays system
warnings, measurements, status information, and other system messages.
 Table Side Unit (TSU), which functions as a point and select device, used by the physician to operate the GUI during a clinical
procedure. For a detailed description refer to the section, Table Side Unit (page 19).
 MediGuide™ Technology Technician Interface Station, which mirrors the display of the bedside monitors and includes a keyboard
for typing in alpha-numeric patient data, clinical system operation, and maintenance purposes such as archiving and deleting study
data.
Hardware Controls
The fluoroscopy system’s Fluoroscopy and Cine Pedals are located on the floor next to the physician. These pedals (refer to the next
figure) are used to start/stop fluoroscopy and cine recording. These pedals are not part of the MediGuide™ System. Follow your facility's
authorized operator requirements for the use of the fluoroscopy and cine pedals, and the Fluoroscopy System.

18
Figure 8. Fluoroscopy and Cine Pedal

1. Cine Pedal
2. Fluoroscopy Pedal

Accidentally stepping on this pedal at any time will result in an x-ray with the subsequent known hazards.
X-RAY RADIATION
The pedal functionality exposes the user and patient to x-ray radiation.

Table Side Unit

The Table Side Unit (TSU) depicted in next figure is used to select a menu item or activate a button on the MediGuide™ Technology GUI
or to manipulate a displayed 2D image or the 3D display on the Secondary Monitor using the approved connected mouse.

Figure 9. Table Side Unit

To select a specific GUI element:

 While watching the MediGuide™ System displays, move the mouse pointer over the desired GUI element (menu item or button).
 Press the <left> mouse button. The operation corresponding to the selected GUI element will be performed.
The display of 2D images and 3D objects can be manipulated via the mouse.
To zoom a 2D image or 3D display in or out:
Place the mouse cursor over the relevant display, press down the <right> mouse button, move the cursor up (to zoom in) or down (to
zoom out) until you get the desired zoom, and then release the mouse button.
To pan a 2D image or 3D display:
Move the mouse cursor over the relevant display, press down the <middle> mouse button, move the cursor to the desired location, and
release the mouse button.

19
To rotate the 3D display:
Move the mouse cursor over the 3D display, press the <left> mouse button, move the cursor in the desired directions, and release the
mouse button. This action can only be performed in the Secondary Display, when a fluoroscopy image is not being shown.

20
Using MediGuide™ Technology
Conventions
The following conventions are used when describing the interaction with the MediGuide™ system:
 Hardware System Parts are stated in initial caps, e.g., Patient Reference Sensor
 System modes are stated in initial caps, e.g., System Mode
 Menu entries, user messages, windows, and control names are specified in bold-faced characters, e.g., Patient Setup window
 Hardware controls (such as pushbuttons, levers, and switches) are indicated within angled brackets, e.g., <Shift>
 Software buttons are indicated in bold-faced characters within square brackets, e.g., [OK]
 Operations where special care should be taken are stated in capital and bold letters, e.g., OFF

System Start-up and Shutdown

It is recommended to start-up and shut down the MediGuide™ System at the beginning and end of the day, respectively.
NOTE: Before starting or using the system, verify that all equipment in the procedure room is approved for use in the facility.
NOTE: The system requires a 7 minute warm-up period.

System Start-up
System start-up consists of two steps, to be performed in the following order:
1. System Power-up.
2. Start-up Verification Procedure (Morning Test).

System Power-up
To power-up MediGuide™ Technology:
1. Ensure the fluoroscopy system is powered on.
2. Push the TSU Power Switch located within the TSU. Refer to the next figure.
NOTE: If the system was shut down immediately prior to an intended power-up, wait for at least 2 minutes before powering up.
CAUTION: Only connect the supplied mouse to the USB port on the TSU. Take precaution to not connect any other
device.
NOTE: If system does not power up with a push of the TSU Power Switch, ensure the On/Off switch in MediGuide™ System
Console is in the On position. Once verified, repeat step 1.

Figure 10. TSU Power Switch

Power ON verification can be done by MediGuide™ Connect LEDs indication as shown in the next figure.

21
Figure 11. MediGuide™ Connect Green and Red LEDs

1. Red LED - The red LED will be either on or blinking when the
MediGuide™ System is either in the power-up /shutdown process or in
modes indicating system failure.
2. Green LED - If the green LED is blinking, the system power is ON.

NOTE: During system power up and shut down, both the red and green LEDs will blink until the MediGuide™ System
applications are completely initialized or shut down. This is normal operation.
3. In the Login Screen (refer to the next figure) select the appropriate user name. For clinical procedures, choose the user name
"Clinical". Type in the password and FCE Name. Click the [Login] button.

Figure 12. Login Screen

NOTE: Before proceeding to the next step, wait until all diagnostic tests have successfully been completed (refer to the next
figure).

22
Figure 13. System Diagnostic tests completed

4. Select the appropriate application from the MediGuide™ Clinical Screen (refer to the next figure) for the type of procedure to be
conducted:
- Select the Cardiac Navigation Application for electrophysiology ablation procedures.
- Select the Cardiac Navigation with Angio Survey™ Application for implant procedures.
NOTE: Prior to launching an application, ensure that the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor
Enabled™ device(s) to be used during the procedure are connected (refer to the section, Preparing MediGuide™ Cath
Connect and MediGuide™ Cath Connect, Sensor Enabled™ (page 37)).

Figure 14. Clinical Screen

23
 The selected application will then display (refer to the next two figures).

Figure 15. Cardiac Navigation Application

Figure 16. Cardiac Navigation with Angio Survey™ Application

NOTE: If at any time during MediGuide™ Technology operation there is a need to turn off the magnetic field generated by it,
immediate transmission shut-down can be done via the [Turn Magnet OFF] button. The magnetic field can be immediately
turned on via the [Turn Magnet ON] button (refer to the next two figures).

Figure 17. Turn Magnet OFF button

24
Figure 18. Turn Magnet ON button

Startup Verification Procedure ("Morning Test")

This procedure should be performed once a day after powering-up the MediGuide™ System and before starting MediGuide™ Technology
procedures.

X-RAY RADIATION:
The test requires X-ray radiation. Known radiation protection measures should be taken such as using lead
aprons, etc.

1. Verify that the MediGuide™ Cath Connect, MediGuide™ Cath Connect, Sensor Enabled™, and PRS are connected to the
MediGuide™ Connect.
2. Set the PRS and Morning Test device(s) at least 20 cm (8 in) from the table top and ~15–25 cm (6–10 in) from the Fluoroscopy
system's Flat Detector bottom, in the fluoroscopy field-of-view. If desired, place a small object on the patient table to image, such as
a syringe, plastic bowl, etc.
3. Connect a Morning Test device (i.e. a MediGuide Enabled™ device) to the MediGuide™ Cath Connect and connect a Morning Test
device (i.e. a Sensor Enabled™ device) to the MediGuide™ Cath Connect, Sensor Enabled™. Place the device tips in the MB.
4. Remove any moveable objects from under the table.
5. Set the Imaging System into nominal position (not parked).
6. In Bi-plane systems, ensure that Plane B is in a parked position.
7. Ensure the Imaging System Exam Set control is set to gMPS Exam set.
8. Start a new MediGuide™ Technology procedure, using Morning Test as the patient name.

Figure 19. Enter Morning Test as Patient Name

9. From the MediGuide Connect Setup window, select the PRS number that matches the one used (refer to the next figure). The PRS
serial number is found on the proximal connector of the PRS.

25
 NOTE: The last-used PRS number will be selected in a dropdown menu as a default. If a PRS number is already selected,
verify that the number matches the connected PRS.
10. From the MediGuide Connect Setup window, define the Morning Test device(s) in the dropdown menu of their corresponding
connection port (refer to next figure).

Figure 20. Select/Verify PRS number and define Morning Test device(s)

Figure 21. Patient Setup window

11. When the Patient Setup window is displayed, select No for all Patient Conditions parameters and then click [Start Procedure] (refer
to the previous figure).

26
12. In the Confirm Start Procedure window, click [Bypass Verification] (refer to next figure).

Figure 22. Confirm Start Procedure

13. Verify magnetic system functionality:

NOTE: Do not press the fluoroscopy pedal in steps a-d:
a. Hold the Patient Reference Sensor (Motion Sensor) inside the MB and verify the PRS indication is green in the status area
as shown in the next figure.
b. Hold the Morning Test device tip inside the MB and verify the catheter status in the status area on the Secondary Monitor.
Also verify that the device name displays in white.
NOTE: Do not press the fluoroscopy pedal in this step.
c. Hold the PRS outside the MB and verify the appearance of the "!" Out of MB indication in the status area.
d. Hold the Morning Test device tip outside the MB and verify the appearance of the "!" Out of MB indication in the status
area.

Figure 23. Motion Sensor Valid Status

14. Verify the system is functioning correctly (to be conducted by authorized operator):
X-RAY RADIATION:
The pedal functionality exposes the user and patient to x-ray radiation.

a. Start in LAO60 view.

b. Press down on the fluoroscopy pedal (not cine pedal) to verify imaging of the object on the Primary Display.
Make sure no "interference" is seen on the imaging system's display.
Verify the catheter projection on the fluoroscopy image is accurate.
c. Repeat step b for all three MediGuide™ Cath Connect and all three MediGuide™ Cath Connect, Sensor Enabled™ ports.
Use the MediGuide Enabled™ device to test the MediGuide™ Cath Connect ports and the Sensor Enabled™ device to
test the MediGuide™ Cath Connect, Sensor Enabled™ ports.
d. Repeat step b while rotating the C-Arm from LAO60 to RAO60.
e. Rotate the C-Arm to AP view.
f. Rotate the C-Arm to CRAN40 view.
g. Repeat step b while rotating the C-Arm from CRAN40 to CAUD40.
h. Rotate the C-Arm to AP view.
i. Lower the Fluoroscopy system's Flat Detector height SID to 90 cm.

27
 j. Repeat step b while raising the Fluoroscopy system's Flat Detector height SID from 90 cm to115 cm (or until out of the
MB).
k. Verify that ECG and respiration "flat lines" are refreshed.
15. Close the Morning Test procedure.
16. Disconnect the Morning Test devices and store them. When the PRS is not in use, it should be coiled and stored in the MediGuide™
Connect side panel.

System Shutdown

Figure 24. Clinical Screen - Log off

To shut down the System:

1. Click the [Exit] button in the MediGuide™ Technology Application.
2. A confirmation window displays.
3. Select [Yes] to exit the application, or select [No] to cancel. If [Yes] is selected, the application will exit to the Clinical Screen.
4. Select the Log off icon on the lower left corner of the MediGuide™ System Clinical Screen (refer to the previous figure) to return to
the Login Screen.
5. Select the Shutdown icon on the lower left corner of the Login screen to shut down the system (refer to the next figure).
NOTE: Wait for at least 2 minutes before powering up.

28
Figure 25. Login Screen - Shut Down

NOTE: Pressing and holding the TSU Power Switch for more than 10 seconds will result in an instant and complete hardware
shutdown. Do not use the TSU Power Switch to shut down the system unless absolutely necessary, e.g., if the software
becomes completely unresponsive or the software shutdown method is not working. Contact St. Jude Medical Technical
Support if this occurs.
CAUTION: If the system becomes unresponsive or an unexpected software shutdown occurs, it must be followed by a
full shutdown of the system. Press and hold the TSU Power Switch for 10 seconds. Wait 2 minutes before turning it
back on by pressing the TSU Power Switch.
6. Disconnect the PRS from the MediGuide™ Connect, carefully coil it and store in the MediGuide™ Connect side panel.
7. Carefully coil and store the ECG cable and store it in the MediGuide™ Connect side panel.
8. If desired, disconnect the MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™ until the next
MediGuide™ Technology procedure.

Preparations for a New Procedure

The preparation instructions provided in this section should be performed before the initiation of a MediGuide™ Technology patient
procedure.
NOTE: It is recommended to turn on the system before patient preparation in order to ensure that the system has warmed up
before starting the procedure. Users should also ensure the Morning Test procedure is completed without complication on the
day of the procedure prior to proceeding.
NOTE: Metallic equipment used in the magnetic field during the procedure, such as a sterile drape holder, may affect tracking
and tool projection accuracy.
Perform the following steps to prepare for a new MediGuide™ Technology procedure:
1. Ensure the fluoroscopy system is on and set to a compatible gMPS mode.
2. If the MediGuide™ System has not already been turned on, turn it on and follow the steps in the section, Startup Verification
Procedure ("Morning Test") (page 25).
3. Prepare the patient as required, including the PRS patch and standard ECG electrodes.
4. Connect the PRS cable to the MediGuide™ Connect PRS 2 port, as described in the section, PRS (Motion Sensor) Attachment
(page 30).
5. Connect the PRS to the PRS Patch as described in the section, PRS (Motion Sensor) Attachment (page 30), and the MediGuide™
System ECG cable to standard ECG electrodes.

29
6. In the Login Screen select the appropriate user name. For clinical procedures, choose the user name "Clinical". Type in the
password and FCE Name. Click the [Login] button.
7. Select the appropriate application from the MediGuide™ Clinical Screen for the type of procedure to be conducted:
- Select the Cardiac Navigation Application for electrophysiology ablation procedures.
- Select the Cardiac Navigation with Angio Survey™ Application for implant procedures.
8. Click the [New] button in the Procedure tab to initiate a new procedure.
9. In the Patient Setup Dialog window, verify that the patient data is correct and click [OK].
NOTE: Patient information is imported from the Siemens system. If a patient is not yet entered in the Siemens system, select
[Cancel], have an authorized user input patient information into the Siemens system and select [New] again.
NOTE: If patient information is changed in the Siemens system after beginning a MediGuide™ Technology case, the
MediGuide™ System will prompt the operator to end the current procedure and begin a new procedure. Action: Close
procedure and begin a new one. All cines, fluoroscopy loops, landmarks, etc. will need to be re-acquired in new case.
10. Select the serial number of the PRS being used in the MediGuide Connect Setup window and click [OK].
11. Verify that the patient setup is correct and stable (refer to the section, Patient Setup Verification (page 35)). Click [Start Procedure]
after the delivery catheter/short introducer are introduced and you are ready to acquire fluoroscopy.
NOTE: For accurate projection on recorded fluoroscopy, it is important to minimize the patient's head and arm movement
during the procedure.
NOTE: If Patient Setup indications are not in an acceptable range per Patient Setup Verification (page 35) and the user selects
[Start Procedure], a pop-up window asking the user to "Confirm Start Procedure" will appear. Be sure to select [Return to
Patient Setup], re-evaluate patient connections and parameters until they are within an acceptable range, and choose [Start
Procedure] again.
12. Connect the MediGuide Enabled™ devices to the MediGuide™ Cath Connect and/or Sensor Enabled™ devices to the MediGuide™
Cath Connect, Sensor Enabled™ (refer to Preparing MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™
(page 37)).
NOTE: It is recommended to test each tool in the MB prior to use on patients.
13. If desired, select the devices being used in the MediGuide Connect Setup window and click [OK]. Once a tool is defined in the
MediGuide Connect Setup window, it may be assigned a custom color in the Device Status area as described in the section,
Connecting MediGuide Enabled™ and Sensor Enabled™ Devices (page 38). Tool selection and color customization can be
performed at any other time during the procedure. Alternatively, select a Tool Preset (refer to the section, Tool Presets (page 40)).
NOTE: Do not attempt to connect a MediGuide Enabled™/Sensor Enabled™ device to the MediGuide™ Connect.
NOTE: Before starting a new procedure, verify that no metal objects are present within 20 cm (8 inches) to the MTA or 10 cm
(4 inches) to the MB.

PRS (Motion Sensor) Attachment

CAUTION: Before connecting the PRS to the MediGuide™ Connect, visually inspect it (including its cable) to verify that
it is mechanically intact. If the PRS or its cable is damaged, replace it with a new PRS. Using a damaged PRS may
result in not being able to use MediGuide™ Technology during the procedure.
The PRS should be connected to the MediGuide™ Connect at the port marked "PRS 2" as shown in the next figure.
NOTE: To connect the PRS to the MediGuide™ Connect, lift the cover over the PRS connection ports, connect the PRS, and
then close the cover.
Connecting the PRS to a MediGuide™ Connect port other than "PRS 2" will disable the PRS.

30
Figure 26. PRS Connection to MediGuide™ Connect

1. Verify that the PRS connector is firmly connected to the MediGuide™ Connect port.
2. Attach the PRS to the PRS patch as shown in the next figure.
NOTE: The PRS should only be attached with a St. Jude Medical™ PRS Patch. The PRS has a locating pin and the patch has
a matching groove to ensure that the PRS is oriented in the correct direction and with its motion controlled, as shown in the
next figure.

Figure 27. Patch with PRS attached

3. Peel off the liner of the PRS Patch as shown in the next figure.

Figure 28. PRS Patch Liner

31
4. Choose appropriate site for placing the PRS Patch on the patient's manubrium sternum.
CAUTION: Placing the PRS in other locations on the patient's body might impair the performance of MediGuide™
Technology.

NOTE: Make sure the skin is dry, clean, and free of excessive hair.
5. Attach the PRS patch to the patient's chest as shown in the next figure. The PRS cable must be routed where it does not cause
visual interferences or interferences with the sterile field, and should be secured with tape.
NOTE: The PRS Patch must be attached in the correct direction. Refer to the next figure.

Figure 29. PRS Patch Attachment

WARNING: Do not place the PRS Patch on skin sites with established erythema, lesions, and injuries of any kind. Do
not use the PRS on patients with prior skin irritation after direct PRS Patch contact. Do not leave the PRS patch
attached to the patient's skin for more than 29 days. The PRS Patch in this package is for use only with the
MediGuide™ Technology Motion Sensor PRS and intended for single-use.
NOTE: Any adverse skin reactions observed during or after use should be reported to St. Jude Medical Technical Support.

ELECTRICAL SHOCK
HAZARD:
Using a damaged PRS may result in an electric shock to the patient.

NOTE: Do not place the PRS patch on an EnSite™ surface electrode or defibrillator patch.
NOTE: Affix the PRS patch to the patient's chest such that the PRS cable is directed according to the procedure's needs.
Make sure that blankets, sheets, etc. do not touch or cover the PRS on the patient's body. Covering or touching the PRS may impact
accuracy of projection on cine.
CAUTION: The PRS is intended for multiple uses. Therefore, it must be cleaned after each patient as described in the
section, PRS Maintenance (page 75). When the PRS is not in use, it should be stored in the MediGuide™ Connect side
panel.
CAUTION: In order for the system to operate properly, it is essential that the PRS is not moved. If the PRS is moved
after the acquisition of cines or fluoroscopy recordings, projection of the cines acquired previously may be inaccurate.
In such an event, to use cine background, record new cines after the PRS has been re-attached and DO NOT use the
previously-acquired cines.
CAUTION: A patient's movements, including head-tilting, may cause the PRS to move, resulting in a catheter shift. It is
recommended to minimize these movements. If needed, a comfortable pillow can be used to reduce head motion.
6. Select the PRS number from the MediGuide Connect Setup window (refer to next figure). The window opens automatically at
procedure startup, and can later be opened at any time using the [Tools Setup] button.
NOTE: The last-used PRS number will be selected in a dropdown menu as a default. If a PRS number is already selected,
verify that the number matches the connected PRS.

32
Figure 30. PRS Number Selection

PRS Troubleshooting
Functional Troubleshooting
If after connecting the PRS to the MediGuide™ Connect port marked "PRS2" and attaching the PRS into its patch inside the MB, the PRS
status in the System Display Status Area remains disconnected, replace the Patient Reference Sensor.
If the status remains disconnected after replacing the PRS, contact your St. Jude Medical authorized service representative.
Physiologic Monitoring
During procedures, the cardiac rate and patient respiratory pattern are monitored and the system compensates for these motions for
better projection accuracy.
A window for monitoring the cardiac and respiratory activity can be opened at any time during the procedure. The window for monitoring
both cardiac and respiratory activity is the Patient Setup window.
The Patient Setup window includes the ECG graph, respiration graph, connection status with an EnSite Precision™ system, and a list of
parameters. In this view the current values of the listed parameters, detailing information about ECG signal detection and patient
respiration are displayed. Based on the information in this view, the clinician can initiate corrective actions, before a procedure starts or
during the procedure.
PRS Movement
Once fluoroscopy is acquired, it cannot be used for catheter projection if the PRS is moved or repositioned. The detailed respiration
parameters description is depicted in the next table:

Table 4. Respiration Parameters

Parameter Name Parameter Description Expected Threshold Value Failure Modes

Respiration Motion The angle between the Z-axis of the
Angle PRS (up-down relative to the table) to
the main respiration direction.
Respiration Pattern This parameter summarizes
characteristics of the PRS motion and
analysis of its correspondence to
respiration
0–45= green Failure may indicate an incorrect PRS
45–60= yellow positioning. Verify PRS and patch.
It is mandatory to check
PRS placement if value is
>60 (amber)
> 8 sec If the parameter is continuously amber
while the patient is not moving and the
PRS is valid, check that the PRS is
properly attached and that nothing is
touching it. If needed, reposition the
PRS.

33
 NOTE: In some conditions the respiration parameter might not meet system requirements i.e. small respiration amplitude in
patients using JET ventilation. If this is the case, the [Ignore Resp] button may be used. The use of this option should be
carefully considered before activating.

ECG Connection
1. Verify that the MediGuide™ System ECG cable is connected to the MediGuide™ System ECG port in the MediGuide™ Connect, as
shown in the next figure.
CAUTION: While handling the ECG cable, ensure that conductive parts of the ECG cable do not contact other
conductive parts, including ground, during the MediGuide™ Technology procedure.

Figure 31. ECG cable connection

2. Attach MediGuide™ System ECG electrodes to the patient's chest as shown in the next figure.
NOTE: MediGuide™ System ECG cables are attached to the patient's body using standard off-the-shelf ECG patch electrodes.
3. Attach the 3 MediGuide™ System ECG cable connectors to the electrodes according to their label. Refer to the next two figures for
proper ECG connector attachment.

Figure 32. ECG electrodes and PRS patch placement

1. Right Arm (RA) Patch

2. Left Arm (LA) Patch
3. Left Leg (LL) Patch
4. Patient Reference Sensor and PRS
Patch

34
Figure 33. 3-connector-ECG cable with labels

1. Right Arm (RA) connector

2. Left Arm (LA) connector
3. Left Leg (LL) connector

4. Verify the PRS and ECG cables are securely connected.

5. Route the wires away from the MB area (close to the neck and shoulders) in order to assure that no visual interference will be
caused by the cables.

Patient Setup Verification

After connecting the PRS to the PRS patch and the ECG cables to the ECG electrodes, it is important to verify that the setup is ready for
using the system. Two important signals need to be verified:
 ECG signal
 Respiration signal
These signals may be observed in the Patient Setup window (refer to next figure), which automatically pops up after the PRS has been
selected and confirmed.
Check the appropriate options in the Patient Conditions area:
 Is the patient under General Anesthesia?
 Is the Head Stabilized to prevent PRS movement?
NOTE: Checking No for Head Stabilized will deactivate the Semi-Constant PRS Filter. (This feature is only available in the
Cardiac Navigation with Angio Survey™ Application and is activated by default.)
Observing the Patient Setup window, verify the following items while the patient is in a stable position:
 ECG signal is free of noise, QRS complexes are clearly visible, and the HR displayed matches with the one shown by the Cath Lab's
ECG.
 Respiration signal displays a respiration pattern. The pattern need not be identical, a longer or shorter, as well as deeper or shallower
respiration are acceptable. It is important to verify that at least at some periods of time the respiration graph is green. If the graph
remains amber for a long period of time, while the patient is not moving, refer to the table, Respiration Parameters (page 33) for
respiration signal troubleshooting.
 Below the respiration graph, there are two indicators of the respiration signal, which can be used for verifying that the PRS has been
attached properly. Respiration Motion Angle indicates how close the respiration motion is to an up-down motion (relative to the
chest of the patient, where the PRS is attached). The lower this angle is, higher the expected rate at which respiration will be
correctly identified by the system. Higher values mean that the PRS is sliding more parallel to the skin rather than moving up and
down. The indicator of the angle values is color coded:
- Green: Up to 45°. (considered low values)
- Yellow: 45°–60°. While this is still a legal range, it is advised to observe the positioning of the PRS and see if a better position
can be found.
- Amber: Above 60°. Indicates that the PRS is not positioned correctly.
 Respiration Pattern is an aggregation of motion components of the PRS. Fast or large-amplitude motion, changes in motion
direction, etc. mean that the PRS motion cannot be indicative of respiration. In these cases, the indicator will turn amber. This is not
expected while the patient is still and the PRS is in the MB. If the indicator is amber for a long period of time while the patient is still,
not speaking, and not touched, this may signify that the PRS is not affixed properly to the sternum of the patient.

35
 The system will analyze the patient ECG and respiration parameters continuously as long as the Patient Setup window is displayed.
When the parameters are suitable for starting a procedure, the [Start Procedure] button's frame will become green. Otherwise, it will
be amber.
It is very important to ensure that these signals are clean and stable, as projection on acquired fluoroscopy may be affected by them.
NOTE: Keep the Patient Setup window open until MediGuide Enabled™ and Sensor Enabled™ tools are actually connected
and used. Then click [Start Procedure] to close it.

Figure 34. Patient Setup Verification (ECG and Respiration Signal)

1. ECG signal
2. ECG settings
3. ECG status
4. Respiration signal
5. Respiration analysis
6. Patient Conditions
7. [Ignore Resp]/[Apply Resp] button
8. [Reset Resp] button
9. [Start Procedure] button

Once the MediGuide™ Technology portion of the procedure is about to begin, verify that the frame around the [Start Procedure] button is
green. Click the button. If the frame is amber, make sure that the patient does not move or speak, and that no motion of the patient, C-
Arm, or table is performed for approximately 30 seconds. If the patient setup was performed properly (the frame around the [Start
Procedure] button was green before beginning the procedure), the frame will become green again. If the frame is not green, refer to the
section, PRS Troubleshooting (page 33).
Clicking the [Reset Resp] button the system will re-calculate the patient's respiration motion angle.
NOTE: The [Reset Resp] button is only active before hitting [Start Procedure]. The re-calculation cannot be completed after
starting the procedure.
In some conditions the respiration parameter might not meet system requirements i.e. small respiration amplitude in patients using JET
ventilation. If this is the case, the [Ignore Resp] button may be used to disable the respiration compensation feature. Users may re-enable
respiration compensation by clicking the [Apply Resp] button. Respiration compensation may be disabled/enabled before the procedure
has started and during the procedure. Refer to the section, PRS and System Status Area (page 30) for information on the conditions that
may cause respiration parameters to be invalid.
NOTE: Performance may be deteriorated if the respiration compensation is disabled.
If the [Start Procedure] button was clicked while the frame was amber, the following window shown in the next figure will display.

36
Figure 35. Confirm Start Procedure

It is recommended to click the [Return to Patient Setup] button and verify readiness. If this is not possible, select [Bypass Verification].
NOTE: Performance may be deteriorated if the verification is bypassed. Specifically, the system might not be Ready for Cine
for long periods of time, and projection accuracy on pre-acquired cines may be harmed.

System ECG Settings

MediGuide™ Technology's ECG is designed to detect the ECG R wave for system internal use only. No diagnostic medical data regarding
the patient can be deduced from it. Given the variability in signal morphologies, a per-case adjustment by the user can improve the ECG
R wave detection accuracy. In order to optimize the detection rate, and for signal plotting adjustments, the following parameters can be
changed by the user, before the procedure starts and during the procedure:
 ECG Lead Selection - Select ECG leads I, II, or III. The default setting is lead II. Use this control as often as necessary to optimize
ECG detection.
 ECG Blanking [msec] - Defines the minimum refractory period from a detected R-wave during which the next R wave cannot be
detected. The default setting is 260 ms.
 ECG Sensitivity - Select from high, medium, or low. The default setting is medium. Increase the ECG detection sensitivity if R-waves
are not being detected, and decrease the ECG detection sensitivity if non-R waves are being detected (double triggering on the T
wave, for example).
 Auto-gain - Affects the ECG signal amplitude in the ECG signal area. Use this to change the signal amplitude manually or
automatically. It does not affect R wave detection.
 ECG Timeout [sec] - Defines the minimum time period of undetected ECG to display the message Loss of ECG on the recorded
images.
NOTE: The ECG signal is dynamic, and can change during the procedure depending on signal quality, patient arrhythmias,
cardiac pacing, and other anatomical factors. If the ECG cable is disconnected, the signal display is not refreshed.

Preparing MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™
The MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™ should be connected prior to launching the Cardiac
Navigation or Cardiac Navigation with Angio Survey™ Application.
Once either application has been launched to begin a new study, the configuration in which these device(s) are connected must remain
unchanged or the system will enter an inoperable state. If this occurs, restore the system to an operable state by reconnecting the
device(s) as they were connected prior to starting the study. To change the configuration in which the device(s) are connected after a
study has been started, close the application and initiate a new study with the updated configuration.
1. Verify that the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™ are properly connected to the
MediGuide™ Connect. The MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™ cables should each be
inserted into the MediGuide™ Connect via the one of the connector ports: IB-1, IB-2, or IB-3. Connect the device(s) using one of
the three configurations listed below:
- A single MediGuide™ Cath Connect connected to the MediGuide™ Connect
- A single MediGuide™ Cath Connect, Sensor Enabled™ connected to the MediGuide™ Connect
- Both the MediGuide™ Cath Connect and the MediGuide™ Cath Connect, Sensor Enabled™ connected to the MediGuide™
Connect.
NOTE: A new procedure cannot be initiated unless one of the three listed configurations is used.
2. Mount the MediGuide™ Cath Connect/MediGuide™ Cath Connect, Sensor Enabled™ to the patient table rails at the end of the bed
away from the fluoroscopy flat detector and MTA.
CAUTION: Ensure that the MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™ are securely
mounted on the patient table rail, and handle it with care to minimize the risk of falling and being damaged. Keep a
minimal distance of 70 cm (28 in) between the MediGuide™ Cath Connect and the MTA, when the C-Arm is positioned
at 45° caudal.

37
 NOTE: The MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™ are non-sterile. Care must be taken
when disconnecting devices to keep the connector end of the cable outside of the sterile field in order to avoid contamination of
the sterile field.
WARNING: To avoid overheating, do not cover the MediGuide™ Cath Connect or the MediGuide™ Cath Connect,
Sensor Enabled™.

Connecting MediGuide Enabled™ and Sensor Enabled™ Devices

NOTE: MediGuide Enabled™ devices must only be connected to a MediGuide™ Cath Connect port (A1, A2, or A3) and Sensor
Enabled™ devices must only be connected to a MediGuide™ Cath Connect, Sensor Enabled™ port (B4, B5, or B6).
Connect MediGuide™ Enabled/Sensor Enabled™ device(s) as follows:
1. Connect a MediGuide Enabled™ device to the MediGuide™ Cath Connect or a Sensor Enabled™ device to the MediGuide™ Cath
Connect, Sensor Enabled™ by pushing the connector to its mate in the MediGuide™ Cath Connect/MediGuide™ Cath Connect,
Sensor Enabled™ until it locks in. To adjust the mating orientation, a gentle rotation of the connector might be needed.
NOTE: Refer to the MediGuide Enabled™/Sensor Enabled™ device's Instructions for Use for specific details regarding its
connection.
2. Use the dropdown menu to define each device by the corresponding MediGuide™ Cath Connect/MediGuide™ Cath Connect,
Sensor Enabled™ connection port, as shown in the next figure.

Figure 36. MediGuide Connect Setup window - Define tool

WARNING: Do not connect a MediGuide Enabled™ or Sensor Enabled™ device unless the device has been selected in
the MediGuide Connect Setup window. Connect only devices that match their type as selected in the MediGuide
Connect Setup window. Connecting a device in a different way may interfere with the effectiveness of
cardioversion/defibrillation.
NOTE: Up to three devices may simultaneously be connected to the MediGuide™ Cath Connect and MediGuide™ Cath
Connect, Sensor Enabled™, respectively. Devices may be connected, disconnected, and reconnected throughout the
procedure.
3. Verify that the system indicates recognition of connected MediGuide Enabled™/Sensor Enabled™ device(s) by a change in the
relevant device field status from Disconnected to one of the following statuses, depending on the sensor's position or attachment to
the system:
- Out of MB
- MB Edge
- Disengaged
NOTE: If the catheter name is displayed in white, the status is valid.

38
 NOTE: A default color is assigned to each MediGuide Enabled™/Sensor Enabled™ device. The color may be changed by
clicking on the corresponding port in the Device Status area and selecting the desired color from the color palette (see next
figure).

Figure 37. Customize tool color in the Device Status area

Figure 38. MediGuide™ Cath Connect and MediGuide™ Cath Connect, Sensor Enabled™

1. MediGuide™ Cath Connect, Sensor

Enabled™
2. MediGuide™ Cath Connect

Projection of a MediGuide Enabled™/Sensor Enabled™ device with a distal loop

Figure 39. Magnetic sensor and distal loop projection in display screen

1. Magnetic Sensor – MediGuide™ Technology tracks the device by

its magnetic sensor and displays its real time P&O in the display
screen.
2. Distal loop – The projection of a device’s distal loop in the
MediGuide™ Technology display screen is only a rendering for
reference only. To visualize the location of the distal loop, use
conventional electrophysiology methods such as fluoroscopy, or
visualize using a cardiac mapping system.

39
Users have the option to turn the rendering of the distal loop on or off by clicking on the device’s corresponding port in the Device Status
area and selecting the desired visualization preference.

Table 5. Distal loop visualization options

Distal loop visible Distal loop hidden

Visualization control

Device projection in display screen

Landmark and Tool Presets

Users have the option to create custom tool and landmark configurations and as save them as presets. Once saved, Tools Presets and
Landmark Presets may be loaded during future procedures from the MediGuide Connect Setup window.

Figure 40. Landmark and Tool Preset controls

1. Landmark Preset button

2. Landmark Preset dropdown menu
3. [Save] button
4. [Delete] button
5. Tool Preset dropdown menu

Tool Presets
After setting up the tools in the MediGuide Connect Setup window, users may save the configuration as a Tool Preset. To save a Tool
Preset:
1. Defining tools by connection port using the dropdown menus in the MediGuide Connect Setup window.
2. After all tools have been defined, click the [Save] button.
3. When prompted, input a name for the Tool Preset and click [OK].

40
 NOTE: "CN" will automatically be added as a prefix to the name of Tool Presets saved in the Cardiac Navigation Application and
"CNAS" will automatically be added as a prefix for Tool Presets saved in the Cardiac Navigation with Angio Survey™
Application.
The Tool Preset will now be saved and listed in the Tool Preset dropdown menu. It can be loaded during future studies by selecting it in
the Tool Preset dropdown menu and clicking [OK]. When using the Cardiac Navigation Application, "CN" Tool Presets will be listed first in
the dropdown menu, while "CNAS" Tool Presets will be listed first in the Cardiac Navigation with Angio Survey™ Application.
NOTE: After loading a Tool Preset, verify that devices are connected to the same ports in which they were saved in the Tool
Preset.

Landmark Presets
NOTE: Creating or loading Landmark Presets must be done prior to starting the procedure. Once a study has been started, the
Landmark Preset controls will be disabled.
Users have the option to change the name and color of landmarks, change the order that landmarks will appear in the Landmark tab, or
create custom landmarks. These changes may be saved as a Landmark Preset and loaded during future studies. To create a Landmark
Preset:
1. Open the Landmark Presets window by clicking the Landmark Presets button in the MediGuide Connect Setup window or the [LM
Presets] button in the Procedure tab.
2. There will be a default preset for the Cardiac Navigation Application and the Cardiac Navigation with Angio Survey™ Application.
Users may create a new preset, or edit an existing user-created preset. Default presets may not be edited.
- To create a new preset, select an existing preset and click the [Copy Preset] button. When prompted, type in a name for the
new preset and click [OK]. Proceed to the next step.
NOTE: "CN" will automatically be added as a prefix to the name of Landmark Presets saved in the Cardiac Navigation
Application and "CNAS" will automatically be added as a prefix for Landmark Presets saved in the Cardiac Navigation with
Angio Survey™ Application.
- To edit an existing preset, select it and proceed to the next step.
3. Choose the desired customization options for the Landmark Preset:
- To change the color of a landmark, select it and select a new color from the color palette.
- To change the name of a landmark, select it and input a new name into the Edit Name field.
- Click and drag landmarks to change the order that they will appear in the Landmark tab.

Figure 41. Creating a General Landmark

4. If desired, add General landmarks to the Landmark Preset. General landmarks are generic landmarks created and customized by
the user. Up to four General landmarks may be created.
- Click on the General landmark icon and select a shape for the landmark (refer to previous figure).
- Input a name and select a color for the landmark.
- Icons for General Landmarks will contain a "+" in the top left corner (refer to next figure).
- To delete a General landmark, select it and click the [Delete General] button.
5. Click [Apply] to save changes.

41
6. Click [Close] to exit.
The Landmark Preset will now be saved and listed in the Landmark Presets dropdown menu. It can be loaded before starting a study by
selecting it in the Landmark Presets dropdown menu and clicking [OK]. When using the Cardiac Navigation Application, only "CN"
Landmark Presets will be available in the dropdown menu and in the Cardiac Navigation with Angio Survey™ Application, only "CNAS"
Landmark Presets will be available.

Figure 42. General Landmark added to Landmark Preset

MediGuide™ Technology Key Features

MediGuide™ Technology is designed to meet the needs of various clinical applications. Each application may have its associated
MediGuide Enabled™/Sensor Enabled™ devices and clinical protocols. This section describes core features and available operations
using this platform, regardless of the MediGuide Enabled™/Sensor Enabled™ device used.

Graphical User Interface (GUI)

The MediGuide™ System includes two monitors: the Primary Monitor and the Secondary Monitor.
The controls on the Primary Monitor are organized around the main display screen. At the bottom, the control area comprises a horizontal
set of toolbars, arranged in tabs, that control the various operations of the procedure. On the left, a vertical cine list enables selection of
prerecorded cines for playback on both the Primary and Secondary Monitors.
The GUI of the Secondary Monitor consists of a status bar area under the main display screen. The next few figures show an example of a
Primary and a Secondary Monitor display layout that features a typical MediGuide™ System live fluoroscopy image and a typical 3D
display.
The GUI consists of the following sections:
Display Screen
The Display Screen is the main part of the viewed area and shows 2D and 3D displays. The display window on the Primary Monitor
displays real time fluoroscopy and cines. The display window on the Secondary Monitor displays 3D objects and, when selected, a dual
cine display. By default, both displays show blank screens, until a new patient is initiated or a previous procedure is resumed using the
Last Patient feature (page 66).
Warnings and system messages - system errors are displayed in a window on the secondary display.
Turn Magnet OFF- this control enables immediate shutdown of the MediGuide™ System's magnetic field (refer to the figure, Turn Magnet
OFF button (page 24)). This might be needed when there is a concern of an interference caused by the magnetic field.

Figure 43. Detector Zoom

For small Fluoroscopy system's Flat Detectors the available Detector Zoom modes are:
 25, 20, 16

42
For mid-size Fluoroscopy system's Flat Detector, the available Detector Zooms are:
 39, 32, 26, 20, 16, 10
For large Fluoroscopy system's Flat Detector, the available Detector Zoom modes are:
 48, 42, 32, 22, 16, 11
NOTE: Detector Zoom buttons are not functional on the MediGuide™ System's GUI and are only for display purposes. Detector
Zoom settings can be modified only on the Siemens Axiom Artis 8 system.

Primary Monitor

Figure 44. Primary Monitor Layout - Cardiac Navigation Application

1. Cine List
2. Control area
3. Primary Display screen
4. Edit windows (Edit Landmark, Edit
CT/MR, Edit Fiducial)

8
AXIOM and Artis are trademarks of Siemens.

43
Figure 45. Primary Monitor Layout - Cardiac Navigation with Angio Survey™ Application

1. Cine List
2. Control area
3. Primary Display screen
4. Edit windows (Edit Landmark, Edit
CT/MR, Edit Fiducial)

Cine List
The Cine List is a list of cines recorded during the procedure. Select to display a specific cine by clicking the arrow next to the cine icon.
When Dual Cine is selected, the Cine List enables the action of selecting a cine separately for the left and right display screens by
selecting the appropriate arrow next to the cine icon.
Right click on a cine to display two options: Edit cine name and Delete cine. Click and drag on the cine to move the order of the cine. A
green check mark displays when the cine has been moved in the list order. Refer to the next two figures.

Figure 46. Cine list options

44
Figure 47. Move cine order

Secondary Monitor

Figure 48. Secondary Monitor Layout

1. Secondary Display screen

2. Status Area
3. Model List
4. Motion Box Graphics
5. Edit Panel (with Landmark,
Lesion and Registration
subpanels)

Model List
A list of 3D models and surface models will appear in the Model List on the Secondary Display. The type of models that may appear in the
Model List will depend on the application:
 Surface models will appear in the Model List in both the Cardiac Navigation and Cardiac Navigation with Angio Survey™
Applications.
 3D Angio Survey™ models will only appear in the Model List in the Cardiac Navigation with Angio Survey™ Application.
NOTE: A Surface model and a 3D Angio Survey™ model cannot not be displayed simultaneously.
Right click on a model to display two options: Edit model name and Delete model. Click and drag on the model to move the order of the
model. A green check mark displays when the model has been moved in the list order.

45
Figure 49. Model List in Cardiac Navigation Application

NOTE: Multiple surfaces can be imported. Only one registration can be displayed at any given time. The Surface model icon
with yellow arrows is currently being shown (refer to previous figure).

Figure 50. Model List in Cardiac Navigation with Angio Survey™ Application

NOTE: Only one Angio Survey™ 3D model can be displayed at any given time. The model icon with a yellow check mark is
currently being shown (refer to previous figure). The projection of the model in the display screen can be turned off at any time
via the View tab.

Status Area and Procedure Information

Displayed on the Secondary Monitor, this area provides status and information pertaining to the following system elements:
 MediGuide Enabled™/Sensor Enabled™ device status
 PRS status
 Respiration and ECG status and readiness for cine in terms of motion compensation
The following items are displayed on the Status Area (refer to next figure):
1. Device Status area - lists connected tools, the status of each tool, and the MediGuide™ Cath Connect/MediGuide™ Cath Connect,
Sensor Enabled™ port the tool is connected to.
2. PRS and System Status (Readiness to record a cine, PRS status, and respiration invalidation icons).
3. ECG and Respiration Graphs

46
Figure 51. Status Area

Device Status Area

Once a tool has been defined in the MediGuide Connect Setup window (see Connecting MediGuide Enabled™ and Sensor Enabled™
Devices (page 38)), it will be displayed in the Device Status area. Tools connected to MediGuide™ Cath Connect will appear in ports A1,
A2 and A3. Tools connected to MediGuide™ Cath Connect, Sensor Enabled™ will appear in ports B4, B5 and B6. Change color of a
device by clicking on it and selecting a color from the palette that appears.
When the status of a device is valid (must be defined, connected, and inside the MB), the device's name will appear in white text. If a
device is not operational, its name will be amber colored and the reason will be displayed next to it.

Table 6. Invalid device statuses

Device status message Explanation

Device is currently out of range of the Motion Box.

Device is located at the edge of the Motion Box.

Device selected is defined but physically disconnected from the MediGuide™

Cath Connect or MediGuide™ Cath Connect, Sensor Enabled™.
Device may be defective or the MediGuide Enabled™/Sensor Enabled™ cable
may not be properly connected.

PRS and System Status Area

This area indicates the status of the PRS and whether the system is ready for cine recording. The PRS Indicator icon and Cine Readiness
icon are both green in the next figure indicating that the PRS is valid and the system is ready to record a cine.

Figure 52. PRS valid and system ready to record cine

1. PRS Indicator icon

2. Cine Readiness icon

47
Figure 53. System is not ready to record cine

If the conditions for recording a valid cine are not met, due to either imaging system geometry or setup, irregular respiration, or heart rate,
the readiness for cine indicator will turn amber and the reason for the error will displayed underneath the indicator icons. The next table
shows status icons that may be displayed in this area when the PRS is invalid or conditions have not been met to allow for the recording of
a cine.

Table 7. Status Icons

Icon Icon Name Explanation

PRS Indicator When icon is amber with exclamation point, the PRS is invalid. Read error
message below icon and troubleshoot.

Cine Readiness When icon is amber with exclamation point, the system is not ready to record
a cine. Read error message below icon and troubleshoot.

Big Amplitude Invalidation Respiration amplitude is too large

Velocity Invalidation Respiration velocity above the limit

Small Amplitude Invalidation Respiration amplitude is too small

Angle Invalidation Fast PRS direction

Unstable PRS Invalidation PRS is not stable.

Deviation Invalidation Deviation from respiration motion direction

ECG and Respiration Graphs

The graph area displays real-time graphs of the ECG and respiration readings. Select between the three ECG leads using the drop-down
menu.

48
Figure 54. ECG and Respiration Graphs

Motion Box Graphic

The Motion Box graphic appears in the Secondary Display to allow users to visualize the location of the PRS and MediGuide
Enabled™/Sensor Enabled™ devices within the Motion Box. Connected devices will be visualized by its assigned color. Devices with a
Disconnected status will not be displayed.
A device exiting the Motion Box will remain at the edge of the Motion Box graphic boundary at the point where it exited and the device
status will be shown as Out of MB, as shown in the next figure.

Figure 55. Motion Box Graphic - Device has left MB

In the case that a device has an invalid P&O, the device status will also be shown as Out of MB, but its actual position is unknown so the
device is visualized at the bottom of the Motion Box graphic and its color will be amber, as shown in the next figure.

Figure 56. Motion Box Graphic - Device has invalid P&O

49
Control Area
The Control Area is available on the Primary Monitor only. It is divided into two regions, a top banner where certain operations available
throughout the procedure are accessible and a bottom banner where the structured functionality tabs and toolbars reside. The operations
presented on the top banner are available during the entire procedure, and include:

Table 8. Control Area buttons

Button Title Functionality

Tools Setup Opens a device window where the connections of MediGuide Enabled™/Sensor
Enabled™ devices to the MediGuide™ Cath Connect/MediGuide™ Cath
Connect, Sensor Enabled™ ports can be configured.

Fuse Cine Acts as a toggle button. Activates the Angio Survey™ 2D Fusion feature (only
available for the Cardiac Navigation with Angio Survey™ Application described in
the section, Angio Survey™ 2D Fusion (page 56)).
NOTE: The [Fuse Cine] button will remain active until the feature is deactivated.
Live as Cine Acts as a toggle button. When selected, any fluoroscopy run will be regarded by
the system as a cine, which will be added to the cine list for playback.
NOTE: The [Live as Cine] button will remain active until the feature is
deactivated.
Reset Zoom Resets zoom on the Primary Monitor.
Sets the zoom and viewing direction in the Secondary Monitor display screen to
match the zoom and viewing direction of the fluoroscopy-based display screen
(Primary Monitor).
Single/Dual Cine Acts as a toggle button. Select this button for Dual Cine mode and unselect it for
Single Cine mode.

Screen Capture Saves the current screens to an image file.

Image files (*.jpg) are stored within the procedure directory.

Video Recording Captures a video of both displays. Click button to begin recording. Click button
again to end recording. If not stopped earlier, recording will automatically stop at
1 minute (maximum recording time).
Video files (*.mp4) are stored within the procedure directory.
Virtual Keyboard Acts as a toggle button to turn the virtual keyboard option on or off. When
selected, a virtual keyboard will automatically be opened in the software interface
when the user clicks into any text input field. The mouse may be used with the
virtual keyboard to input characters into the text field.

The bottom banner includes the main procedure work flow controls, set up as tabs dividing the controls according to their functionalities.
Each tab includes a group of buttons, used to activate specific MediGuide™ System operations and settings. Each button is assigned a
specific operation, indicated by a label and/or symbol. The status of the buttons visually indicates as follows:

Figure 57. Button Status

1. Enabled buttons are indicated by white-faced characters and symbols on

a blue background.
2. Currently selected (active) buttons are indicated by yellow-faced
characters and symbols on a blue background and a yellow frame.
3. Disabled buttons are in gray scale.

Selecting an enabled button activates its stated operation, or displays a window, which requires additional user interaction.
In addition to buttons, sliders are controls specifically designed to be used in selection of a specific frame from a cine.
The tabs are used to arrange the control into functionality groups:
NOTE: The specific available controls may vary according to the application. The following figures serve as examples.
 The Procedure tab groups controls (refer to the next figure) that handle the entire procedure, such as starting and ending a
procedure, importing segmented CT/MR models, and restoring. It includes the following operations:

50
Figure 58. Procedure tab

- [New] - Starts a new procedure

- [Close] - Closes a current procedure
- [Patient Setup] - Opens the Patient Setup window
- [LM Presets] - Opens the Landmark Presets window
- [Import CT/MR] - Import a segmented CT/MR image file
- [Preview CT/MR] - Opens a dialog box that can be used to preview imported CT/MR image files
- [Tools] - Opens a software tools window
- [About] - Displays information about the application version
- [Exit] - Exits the application and returns to the MediGuide™ System Clinical Screen.
 The Landmark tab (refer to the next figure) includes buttons for the three MediGuide™ Cath Connect ports (Port 1, Port 2, and Port
3) and the three MediGuide™ Cath Connect, Sensor Enabled™ ports (Port 4, Port 5, Port 6) and a list of landmarks. Landmark
assignment is done from this tab.

Figure 59. Landmark Tab

 The View tab (refer to the next figure) controls whether graphic objects generated during the procedure are visible or not. Each
graphic object may be turned on or off using the buttons on this tab. The options available for the Cardiac Navigation with Angio
Survey™ Application are listed:

Figure 60. View Tab - Cardiac Navigation with Angio Survey™ Application

- [Outer Shaft] - View/hide the device shaft (refer to the section, Catheter Shaft Rendering (page 14)). The [Outer Shaft] button
is selected as a default. To hide the device shaft, press this button.
- [Shaft Clip] - View/hide the Shaft Clip. The Shaft Clip clips the proximal section of the device shaft, thus displaying only the
distal portion of the Shaft Rendering.
- [CS OS Lock] - Renders device shaft trajectory through the CS OS landmark.
- [Correct Shaft] - Enables the use of MediGuide Enabled™/Sensor Enabled™ tools to improve the catheter shaft rendering. The
system locks the shaft of the outer catheter to these MediGuide Enabled™/Sensor Enabled™ tools if they are inside the lumen
of the outer catheter.
- [3D] - View or hide a 3D model (refer to the section, Angio Survey™ 3D (page 57)).
- [Snap to ROI] - Enables/disables the snap of the device projected tip to the ROI (refer to the section, Angio Survey™ 2D ROI
(page 59)), if such a ROI has been created.

51
 The Cine tab enables stopping the cine playback and selecting a specific frame. It has separate controls for the primary and
secondary (if active) cine displays.
- When the [Road Map] button is selected, the cine playback is stopped and an individual frame can be selected using the
yellow frame selection slider or the frame forward/backward buttons. All P&Os of MediGuide Enabled™/Sensor Enabled™
devices and landmarks are projected on the selected still frame. The valid part of the cine will be green. Invalid parts of the
cine will be amber.
- The cine may be cropped by manually moving the cropping editing markers to the desired start and end point. The next two
figures show the Cine tab when single cine view is selected and when dual cine view is selected.

Figure 61. Cine Tab (Single Cine) - Cardiac Navigation with Angio Survey™ Application

Figure 62. Cine Tab (Dual Cine) - Cardiac Navigation with Angio Survey™ Application

NOTE: The Cine tab is available in both Cardiac Navigation and Cardiac Navigation with Angio Survey™ Application.
 The Angio Survey™ 3D tab provides access to all the buttons controlling the flow of 3D model and 2D ROI reconstruction, and
displays relevant text messages. The next figure shows an example of one of the steps of the process.
NOTE: The Angio Survey™ 3D tab is only available in the Cardiac Navigation with Angio Survey™ Application.

Figure 63. Angio Survey™ 3D Tab

 The Imaging Modality tab provides access to all the buttons controlling the flow of surface modality registration. The next figure
shows an example of one of the steps in the process.
NOTE: The Imaging Modality tab is available in both Cardiac Navigation and Cardiac Navigation with Angio Survey™
Applications.

Figure 64. Imaging Modality Tab

52
Key Features Available During Procedure
After the preparation steps are performed and at least one MediGuide Enabled™/Sensor Enabled™ device is connected to the system
and inserted into the patient, the following features are available to the operator according to the procedural sequence of the specific
device:
Fluoroscopy
The operator may take, at any time during a MediGuide™ Technology procedure, a fluoroscopic view of the anatomy using the standard
C-Arm fluoroscopy pedal.

X-RAY RADIATION:
The pedal functionality exposes the user to x-ray radiation.

The fluoroscopy images will be displayed on the Primary Monitor (on the left).
During fluoroscopy, any valid MediGuide Enabled™/Sensor Enabled™ device present in the imaged anatomy will be tracked on the
fluoroscopy images. Whenever Shaft Rendering is applicable (depending on the application in use, the MediGuide Enabled™/Sensor
Enabled™ device and the flow), the device shaft is rendered. To hide the rendered shaft, select the [Outer Shaft] button on the View tab.
Cine Recording and Playback
The operator may record, at any time during a MediGuide™ Technology procedure, a fluoroscopic cine of the anatomy using the standard
C-Arm cine recording pedal.

X-RAY RADIATION:
The pedal functionality exposes the user to x-ray radiation.

During recording, the cine will be displayed on the display screen of the Primary Monitor. Recording status messages are displayed on the
top right corner of the cine.
After the recording is complete, the cine is added to the Cine List. The cine is played back in a loop in synchronization with real time ECG.
Any cine may be selected from the cine list at any time. The most recently selected cine will be played back in a loop. When Dual Cine
mode is selected, a cine may be selected for playback in each display screen separately. To select a cine for a certain display screen,
click the left/right arrows next to the selected cine icon. The arrow will turn yellow when selected.
The operator may select a Roadmap image from the selected cine to be displayed as a still image.
NOTE: When the [Road Map] button is selected, catheter movement may appear less fluid on the display screen.
When a cine is played back, any MediGuide Enabled™ or Sensor Enabled™ device present at the imaged anatomy will be tracked on the
cine. If a Roadmap image was selected, MediGuide Enabled™ and Sensor Enabled™ devices will be tracked on the Roadmap image. In
addition to MediGuide Enabled™/Sensor Enabled™ devices, other 3D objects such as landmarks will also be displayed on the underlying
selected images.
Cine Cropping/Uncropping
If the recorded cine has a valid region of at least two seconds in duration, the recorded cine is automatically processed and invalid
segments are cropped out and not displayed. If the recorded cine does not have a valid region of at least two seconds in duration, no
automatic cropping occurs and the cine is invalid.

Table 9. Recorded Cines

Cine Description Cine Frame (in Cine Tab) Cine List Icon
Entire recorded cine is valid.
Valid cine icon in Cine List.

Recorded cine has valid region of more than two seconds in

duration.
Valid cropping region detected. Invalid regions automatically
cropped out.
Valid cine icon in Cine List.

53
Table 9. Recorded Cines

Cine Description Cine Frame (in Cine Tab) Cine List Icon
Recorded cine does not have valid region of more than two
seconds.
No valid cropping region detected. No automatic cropping
performed.
Invalid cine icon in Cine List.
NOTE: Invalid cines will be marked with the amber exclamation point ! in the Cine List, as well as a banner reading Non
compensated cine selected. While they may be used, the projection accuracy of invalid cines may be degraded.
The user has the option to override automatic cropping and manually select the portion of the cine to be played back. To access the cine
cropping feature, navigate to the Cine tab and press the [Road Map] button (see next figure). In the Dual Cine view, use the left or right
arrow next to the Cine Selection icon to select the desired cines for cropping.

Figure 65. Road Map button

When the [Road Map] button is activated, the cropping sliders will become white. Users may move the sliders to the select the start and
end point for cine playback. If one or more frames from an invalid region of the cine is included when cropping, the cine will become
invalid. The icon in the Cine List will be changed to show that the cropped cine has become invalid.
The icon for any cropped cines (valid or invalid) will have a partial border in the Cine List, as shown in the next table.

Table 10. Cropped Cines

Cine Description Cine Frame (in Cine Tab) Cine List Icon
System automatically crops out invalid region of recorded
cine.

User-cropped cine is valid. Cropped region contains only

valid frames.

User-cropped cine is invalid. Cropped region contains invalid

frames.

Landmark Assignment
The operator may place landmarks of anatomical features of interest using a magnetic sensor's P&O to place a landmark. Select the
MediGuide Enabled™/Sensor Enabled™ device for landmark assignment in the Landmark tab and then select the landmark to be
assigned, as shown in next figure.
NOTE: When assigning a landmark using a catheter with a non-rigid distal tip, e.g. a circular mapping catheter, the landmark
will be placed at the location of the magnetic sensor.
Multiple lesion landmarks may be assigned by the user (up to 1024 assigned lesions can be supported at one time by the system).
Lesions may be assigned using the method described above, or by using the shortcut key <F6>. To do so, select a device in the
Landmark tab and press <F6> when the tool tip is positioned in the desired location.

54
Figure 66. Landmark Assignment

1. While in the Landmark tab,

select the MediGuide
Enabled™/Sensor
Enabled™ device that will
be used to assign the
landmark.
2. Select a landmark. It will be
assigned at the the tip of the
magnetic sensor of the
selected device.
3. View a list of assigned
landmarks by opening the
Landmark subpanel.
Assigned lesions may be
viewed in the Lesion
subpanel.

Once a landmark is created, it may be displayed on all 2D and 3D displays. For anatomic landmarks (e.g. LIPV, CS OS, etc.), only one of
the given landmark can be shown at any time. Multiple non-anatomic landmarks (e.g. lesions, point mark) may be shown simultaneously.
The next two figures show an example of Landmarks projected on a cine in 2D and the same Landmarks in 3D.

Figure 67. Landmarks viewed in 2D

55
Figure 68. Landmarks viewed in 3D

An assigned landmark or lesion may be customized by the user. Features that may be customized include color, name, size, and
orientation. For more information on landmark customization, refer to the section, Customizing a Landmark (page 69).

Angio Survey™ 2D Fusion

NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application.
Angio Survey™ 2D Fusion enables the user to view live fluoroscopy with an overlay of matched pre-recorded fluoroscopy. This feature can
be used to fluoroscopically view the tools used in the procedure with an overlay showing an angiogram or venogram of a relevant vascular
anatomical structure, e.g., the coronary sinus (CS). This enables the user to locate the tools with respect to the anatomy. To use the Angio
Survey™ 2D Fusion, the following steps need to be performed:
1. Record a cine imaging a desired anatomy (for example, an angiogram of the anatomy) from your preferred projection.
2. If the C-arm has moved from the angiogram acquisition position, reposition the C-arm to the acquisition position. Select the [Fuse
Cine] button as seen in the next figure.

Figure 69. Fuse Cine Control- Cardiac Navigation with Angio Survey™ Application

NOTE: If desired, assign the CS Ref landmark inside the CS. The CS Ref landmark is used for cardiac compensation of Angio
Survey™ 2D Fusion.
3. Activate live fluoroscopy by depressing the fluoroscopy pedal. When live fluoroscopy is used, the recorded cine will display and
overlay in shades of green. Manipulate the tools as needed using the anatomical information projected by the fused cine.
X-RAY RADIATION:
The pedal functionality exposes the user to x-ray radiation.

NOTE: If the C-arm is moved more than 10 degrees or more than 10 cm of SID from the angiogram acquisition position, Angio
Survey™ 2D Fusion will temporarily disable. Minor motion of the patient or the table is permitted and will be compensated for.

56
4. To control the opacity of the overlay, use the arrow controls at the left of the display (refer to the next figure).

Figure 70. Angio Survey™ 2D Fusion Opacity Control

5. To deactivate the Angio Survey™ 2D Fusion, select the Fuse Cine control again.

Angio Survey™ 3D
NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application
With Angio Survey™ 3D, it is possible to reconstruct a 3D model of a vascular anatomy using two angiograms taken from different
projections. The reconstructed vascular model can then be displayed in 3D or be projected on fluoroscopy, live or prerecorded.
To reconstruct an Angio Survey™ 3D model, the following steps need to be performed:
1. Record two angiograms of the anatomy, keeping in mind the following:
- The angiograms have to be taken at least 40º apart.
- It is recommended to position the patient's heart in the center of the field of view of the fluoroscopy to ensure all parts of the
anatomy are visible in the acquired angiogram.
- It is recommended to isocenter the patient so no table movement will be required between the two C-arm angles.
- It is recommended to select projections where the region of interest in the anatomy has the overall minimum foreshortening.
2. Select the Angio Survey™ 3D tab (refer to the next figure).
3. Select the cine with the less foreshortening (typically LAO) of the two for the left display, and the other cine selected for the right
display. After assigning the two cines to be used, the [Next] button will be enabled.
4. Click [Next].
5. Using the frame controls, select a frame on the left cine. Once selected, only frames matching the cardiac phase of the selected
frame will be available on the right cine. These are indicated by a blue dot appearing above the frame.
6. Using the forward/backward arrows, select a frame on the right cine.
7. Click [Next].

57
Figure 71. Angio Survey™ 3D

8. Mark the region of interest (ROI): Refer to the next figure.

- Starting from the proximal part of the anatomy, mark a point on the left cine by clicking the left mouse button.
- A line crossing the anatomy (epi-polar line, the projection of the point selected on the left cine) will appear on the right cine
image. Its crossing point with the vessel serves as a hint to where the corresponding point should be marked. Mark the point on
the right cine.

Figure 72. Angio Survey™ 3D- Marking ROI

NOTE: The epi-polar line is an approximation of the plane on which the corresponding point may be located. Use it only as a
hint and mark the exact corresponding point based on his or her judgment.
- Repeat steps 1 and 2 until the ROI meets your needs.
NOTE: If a point was entered incorrectly, select the [Undo Last] button to undo its marking.
- Select the [Apply] button to reconstruct the model. The projection of the reconstructed model will show on both angiograms
(refer to the next figure).

58
Figure 73. Angio Survey™ 3D model projection on Cine

NOTE: If the lumen boundaries of the model deviate from the actual vessel boundaries, use the [Edit Lumen] button to correct
them on the primary display. Lumen is edited by dragging the mouse with the left button pressed over the correct path of the
wall.
9. To add a branch to the reconstructed model (refer to the next figure):
a. Select the [Add Branch] button.
b. Mark points along the desired branch using the mouse on the left angiogram.
c. Mark the corresponding points on the right angiogram, with the help of the epi-polar lines that will display.
d. Upon completion, select the [Apply] button to create the branch.
e. If needed, adjust the branch's boundaries by dragging them using the mouse.
f. Select the [Apply] button.
10. To add multiple branches, repeat steps a through f.
11. When all desired branches are added, select [Finish]. MediGuide™ Technology will return to cine playback in both displays with the
newly constructed Angio Survey™ 3D model overlaid.

Figure 74. Angio Survey™ 3D Add Branch

Angio Survey™ 2D ROI

NOTE: This feature is only available for the Cardiac Navigation with Angio Survey™ Application.

59
With Angio Survey™ 2D ROI, it is possible to improve the display of projected devices on the cine playback. 2D ROI will stabilize the tool
marker within the ROI and thus help the physician to track the tool especially when moving in small sub-branches.
NOTE: A constructed Angio Survey™ 2D ROI model will only display on the cine on which it was created. It cannot be
extrapolated through other cines (unlike an Angio Survey™ 3D model).
To reconstruct an Angio Survey™ 2D ROI model, the following steps need to be performed:
1. Record a cine imaging a desired anatomy (for example, an angiogram of the CS) from your preferred projection.
2. Press the Angio Survey™ 3D tab. Instructions will be displayed in a sequence of windows that lead the user through a series of well-
defined steps.
3. Select the same cine for both displays (Primary and Secondary Display).
4. Using the slider or arrow buttons, select a frame on the left angiogram where the anatomy is adequately seen.
5. Mark the ROI directly on the angiogram.
NOTE: It is recommended to mark the first point of the 2D ROI distally to the angiogram balloon projection on the screen.
6. When the ROI is complete, click the [Apply] button.
7. Select the [Add Branch] button on the Angio Survey™ 3D tab.
8. Mark a point close to the bifurcation on the main ROI.
9. Mark more points on the branch moving proximal to distal.
10. Select the [Apply] button.
11. Repeat steps 7-10 until all desired branches are marked.
12. Select the [Enhance 3D] button in the Angio Survey™ 3D tab. The application will display the next frame on the left display screen
with the updated ROI superimposed.
13. Click through the frames using the forward/backward arrows to check the accuracy of the system’s extrapolation of the ROI. In the
case that the ROI is incorrect, move any incorrect point placement by left clicking and dragging a point to the correct position. Select
[Apply] after each movement.
14. Select [Next] to proceed to the next pair of frames.
When a complete cardiac cycle has been covered, the [Next] button will be disabled.

Figure 75. Angio Survey™ 2D Propagation

15. Select [Finish].

60
It is recommended to mark the first point of the 2D ROI distally to the angiogram balloon projection on the screen.
NOTE: ROI is not seen onscreen, rather only when a device enters the ROI. When the device is positioned within the assigned
ROI position, a magenta-colored ring displays around the device tip. The guidewire will change to a magenta color.
NOTE: To disable device position optimization on a cine, enter the View tab and deactivate [Snap to ROI]. This may be
enabled or disabled throughout the procedure.

Surface Modality Registration

MediGuide™ Technology is capable of fiducial-based registration using DICOM-formatted CT/MRI/Dyna CT surface files, imported from a
USB device, CD/DVD, an EnSite™ Cardiac Mapping System, a network drive, or a hospital PACS server. The surface model can then be
displayed in 3D or be projected on fluoroscopy, live or pre-recorded.
WARNING: Within the MediGuide™ Technology coordinate system, proper registration is dependent on correct
identification and placement of fiducials on anatomical locations within the 2 dimensional X-Ray image and 3
dimensional CT model. The CT model represents a previously acquired anatomy and may not correspond to the X-Ray
image. Do not use the registered surface model as the means of navigation. Confirm catheter position relative to the
anatomy using conventional means (e.g., fluoroscopy, intracardiac echocardiography).
NOTE: When using this feature, the system switches to Road Map mode, which may cause tool projection to appear less fluid
on the display screen.
NOTE: If a Sensor Enabled™ device has been advanced into the coronary sinus during the study, assign the CS Park or CS OS
landmark at the appropriate anatomical location or registration compensation accuracy may be affected.
To register a surface model, perform the following steps:
1. Record a cine and load it on the Primary Display.
2. Click the Imaging Modality tab.
3. Press the [Load CT/MR] button. A dialog box will open contain a list of models files that may be loaded.
4. Select a model and click [OK] to load it. Once the model is loaded, it will be displayed in the Secondary Display.
NOTE: A model must be imported into the MediGuide™ System before it can be loaded for registration. Click the [Import
CT/MR] button to go to the Archive utility and import a segmented model. The model will automatically be loaded once the
import process is complete. If it is desired to register a model imported from an EnSite™ Cardiac Mapping System, it must be
imported via the EnSite™ Cardiac Mapping System’s data archiving system from outside the EnSite™ Cardiac Mapping System
case.
5. Place fiducial points with one of the options described below:
NOTE: To assist in verifying 2D fluoroscopy locations for registration to a 3D model, use alternate fluoroscopy views or
conventional means (e.g., fluoroscopy, intercardiac echocardiography).
To place a fiducial point at the tip of a MediGuide Enabled™/Sensor Enabled™ device, follow the steps below, as shown in the next
figure.
- Select the device that shall be used to place the fiducial point in the Imaging Modality tab.
- When the device tip is satisfactorily positioned, double-click on the matching location on the surface model to assign a pair of
corresponding fiducial points - one at the tip of the device and one on the surface model. Be as accurate as possible when
selecting the corresponding location on the surface model to assign the fiducial.
NOTE: Fiducial will be placed at the tip/sensor’s location. This is particularly important to note on devices with non-rigid ends,
e.g. circular mapping catheters.

61
Figure 76. Placing fiducial points at tool tip

NOTE: If the catheter is moving too fast when a fiducial point is placed, it may not be compensated correctly and the system
will display a message suggesting the user delete and replace the fiducial point (see next figure).

Figure 77. System Message - Replace fiducial point

To place a fiducial at a landmark, follow the steps below, as shown in next figure:
- Select the landmark that the fiducial point shall be placed at. Select by clicking directly on the landmark displayed in the
Primary Display or choosing from the list of assigned landmarks in the Landmark subpanel.
- Double-click at the matching location on the surface model to assign a pair of corresponding fiducial points - one at location of
the landmark and one on the surface model. Be as accurate as possible when selecting the corresponding location on the
surface model to assign the fiducial.

62
Figure 78. Placing fiducial point at landmark

6. When one or more pairs of fiducial points have been placed, registration can be completed by pressing the [Register] button.
NOTE: The registered surface model is a guide to the user which represents a previously acquired anatomy.

NOTE: Confirm the catheter position relative to the anatomy using conventional means (e.g., fluoroscopy, intercardiac
echocardiography).
NOTE: Once a surface model has been registered, it will appear in the Model List with a green border.

NOTE: Using the Delete button to remove all placed fiducial points for a registered model will remove registration. Models that
are not registered will appear in the Model List with an amber border.
The [Undo] button removes previously placed fiducial points in order of placement, but does not undo registration. To delete a surface
model after it has been registered, right-click on the appropriate surface model icon in the model list and select Delete model.
NOTE: Fiducials may be deleted or deactivated from the Fiducials list in the Registration subpanel in the Edit Panel.

Figure 79. Deleting a registered surface model

To repeat the registration process for a previously registered model, load the same model using the [Load CT/MR] button in the Imaging
Modality tab and repeat the steps listed above. The new surface model will be added to the model list upon completion of registration.

Manual Adjustment of Model

The positioning of the model may be manually adjusted by users after registration. It is recommended to perform manual adjustment in
the 3D window; however, manual adjustment may be done in either screen. It is also recommended to observe the model from different
views during manual adjustment by using the torso views or using the mouse to change the viewing angle in the 3D window.
1. Open the Edit Panel.
2. In the Edit Panel, select the Registration subpanel.
3. In the Registration subpanel, select the model. A bounding box around the model will appear.
4. In the Edit CT/MR window, activate the Move/Rotate button. A new bounding box will appear allowing for manual adjustment.
5. To adjust the positioning of the model, place the cursor in the bounding box and use the options described below.

63
Figure 80. Manual Adjustment of Model

1. Move Cursor – Click and drag with

this cursor to move the model on
the x- or y-axis
2. Rotate Cursor – Click and drag
with this cursor for free 3D
rotation. Rotate may only be
performed in the Secondary
Display.
3. Roll Cursor – Click and drag with
this cursor to rotate the model
clockwise or counterclockwise.

NOTE: The [Register] button does not need to be clicked after finishing manual adjustment.
NOTE: Fiducial points will not move in the display screens when doing manual adjustment.

Editing Surfaces and Fiducials

Models and fiducials may be edited using the editing options contained in the Edit Fiducial and Edit CT/MR windows. If a model has
multiple surfaces, the sub surfaces may be individually selected and edited as well.
1. Open the Edit Panel.
2. In the Edit Panel, select the Registration subpanel.
3. In the Registration subpanel, select the model, sub surface, or fiducial to be edited.
4. Edit the selected model or sub surface using the options in the Edit CT/MR window:

64
 1. Delete – Delete selected model or sub surface
2. Undo – Undo last action
3. Redo – Redo last action
4. Move/Rotate – Click button to enable manual adjustment of the selected model
(move, rotate, roll)
5. Show/Hide – Show or hide the selected model or sub surface
6. Show/Hide Text – Show or hide the name of model or sub surface
7. Change Color – Change the color of selected model or sub surface
8. Edit Name – Edit name of selected model or sub surface
9. Opacity – Adjust opacity of selected model

5. Edit a selected fiducial using the options in the Edit Fiducial window:
1. Delete – Delete selected fiducial
2. Undo – Undo last action
3. Redo – Redo last action
4. Activate/Deactivate – Click to activate/deactivate a fiducial pair. When
deactivated, a fiducial pair will be ignored when calculating registration
5. Change Color – Change the color of selected object

65
MediGuide™ Technology Procedure Guidelines
Setup
1. Follow the startup and patient preparation steps as described in the section, Preparations for a New Procedure (page 29).
2. Start a new procedure by pressing the [New] button.
3. Verify the patient procedure data in the appropriate fields in the Patient Data Dialog window (refer to the next figure). This
information is automatically obtained from the Siemens Axiom Artis 9 system.
NOTE: If a new patient is registered on the Siemens system after beginning a MediGuide™ Technology case, the MediGuide™
System will prompt the operator to end the current procedure and begin a new procedure. Action: Close procedure and begin a
new one. All cines, fluoroscopy loops, landmarks, etc. will need to be re-acquired in the new case.

Figure 81. Patient Data Dialog Window

Last Patient Feature

A previous session can be recovered and continued from where it was stopped, using the [Last Patient] button.
A previous procedure can be resumed, using all acquired data and definitions. This is useful in cases of a session aborting abnormally,
where the user wishes to proceed with the case using all acquired data.
After shut down, select the [Last Patient] button in the Patient Data Dialog window (see previous figure) before clicking [Next].
Select the last patient and the procedure resumes with all the previously acquired cines, landmarks, etc.
The [Last Patient] feature can be used multiple times, as long as the patient name was not changed. Users may switch from the Cardiac
Navigation Application to the Cardiac Navigation with Angio Survey™ Application (or vice versa) when resuming a procedure.

MediGuide Enabled™/Sensor Enabled™ Device Connection and Use

1. Connect, reconnect or disconnect a MediGuide Enabled™/Sensor Enabled™ device whenever appropriate during the procedure.
NOTE: The available MediGuide Enabled™/Sensor Enabled™ devices for selection will be configured by a technician,
according to device availability and procedure type.
2. Configure the device type (select the relevant type of device from the list that opens below each MediGuide™ Cath
Connect/MediGuide™ Cath Connect, Sensor Enabled™ port) and connection port using the MediGuide Connect Setup window.
NOTE: Before using a device invasively, it is recommended to test its functionality after it is connected to the MediGuide™
Cath Connect by placing it under the Fluoroscopy system's Flat Detector and verifying that the status has changed and the
catheter position is tracked.

9
AXIOM and Artis are trademarks of Siemens.

66
3. Use the MediGuide Enabled™/Sensor Enabled™ devices according to the device's user manual, and observe their tracking on the
relevant system displays. Once a MediGuide Enabled™/Sensor Enabled™ device is connected and placed in the MB, it will be
tracked by the system and displayed in all active display screens, either in 3D or superimposed on fluoroscopy.
NOTE: Like any other invasive device, MediGuide Enabled™/Sensor Enabled™ devices may be tracked on the imaging
system's displays using standard fluoroscopy.

Fluoroscopy Recording and Viewing

During the procedure, fluoroscopy may be used. To take advantage of MediGuide™ Technology's capability of displaying device and
landmark tracking on previously acquired fluoroscopy, record one or more cines from any selected C-Arm angulation, within MediGuide™
Technology limits specified in the section, System Specifications (page 17). The most recently recorded cine will be played back on the
display screen of the Primary Monitor automatically. A different cine may be chosen by selecting it on the cine list. Whenever live
fluoroscopy is taken, whether using the fluoroscopy pedal or the cine pedal, the live fluoroscopy will be displayed instead of the cine on
the Primary Monitor, with the MediGuide Enabled™/Sensor Enabled™ devices and landmarks superimposed.

X-RAY RADIATION:
The pedal functionality exposes the user and patient to x-ray radiation.

To record a cine, follow these steps:

1. Position the C-Arm at the desired angulation.
2. Verify that the PRS icon is green, and that no status message appears next to it (refer to the next figure).
3. Wait for the Cine indicator in the Status Area to display Ready for Cine in green (refer to the next figure).

Figure 82. PRS indicator and Cine indicator

1. PRS indicator
2. Cine indicator

4. Press the cine pedal and hold until the Recording Cine banner on the top of the display window turns green. The cine will be added
to the Cine List and will be played back on the primary display.

X-RAY RADIATION:
The pedal functionality exposes the user to x-ray radiation.

5. If the cine duration is too short (< 2 sec), an error message will display and it will not be added to the cine list.
6. If during the cine recording an abrupt change of the patient's ECG, respiration, or position has occurred, the banner at the top of the
image will turn cyan and the displayed cine will not be validated. The cine will be added to the cine list with an amber exclamation
point "!". Invalid Cines will not be automatically played back (unless it is the first Cine). To select this cine, click the left or right arrow
next to its icon on the cine list.
NOTE: It is suggested to record a cine using the regular fluoroscopy pedal. To do that, press the [Live as Cine] button in the
control area, as explained in the section, Status Area and Procedure Information. As long as this button is selected, any
fluoroscopy will be treated as a cine, added to the cine-list, and used as a background for projection.

X-RAY RADIATION:
The pedal functionality exposes the user to x-ray radiation.

CAUTION: Using a cine with an amber exclamation point ! might result in deteriorated projection accuracy for catheters
and landmarks.

67
A 3D display of the MediGuide Enabled™/Sensor Enabled™ devices and landmarks will show on the Secondary Monitor if the dual cine
view is not selected.
To select Dual Cine view, use the Dual Cine button in the top banner of the Control Area. Click the left or right arrow next to the cine icon
to display the cine on the Secondary Monitor. Whenever two cines are selected, they will both be played back with MediGuide
Enabled™/Sensor Enabled™ devices and landmarks superimposed.
If Dual Cine view is selected while live fluoroscopy is taken, it will show on the Primary Monitor, and the cine selected for the Secondary
Monitor will continue playing.
To use a still image rather than cine playback for projection background, use the [Road Map] button in the Cine tab.

Landmark Assignment
Landmarks may be assigned at anatomical points of interest. To assign a landmark:
1. Select an available MediGuide Enabled™/Sensor Enabled™ device from the Landmarks tab.

Figure 83. Assigning Landmarks - Cardiac Navigation Application

2. When the device tip is positioned at the target anatomy, select the appropriate landmark from the list in the Landmark tab as shown
in previous figure. Refer to the section, Landmarks (page 13) for the complete list of available landmarks.
NOTE: When assigning a landmark using a catheter with a non-rigid distal tip, the landmark will be placed at the location of the
magnetic sensor.
NOTE: Up to 1024 lesions may be assigned.
3. From this point on, the landmark will be displayed on all active MediGuide™ System displays.
NOTE: If the catheter is moving too fast when a landmark is placed, it may not be compensated correctly and the system will
display a message suggesting the user delete and replace the affected landmark (see the next figure).

68
Figure 84. System message - Replace landmark

Customizing a Landmark
User-assigned landmarks may be customized. To customize a landmark:
1. Select the desired landmark/lesion by clicking on it in a display screen or selecting it from the Landmark or Lesion subpanel. A
bounding box will display around the selected landmark or lesion.
NOTE: Multiple lesions may be customized at the same time. To select multiple lesions to customize, hold <Shift> or <Ctrl>
while selecting lesions in the Lesion subpanel. Users may select all assigned lesions with the [All Lesions] button.
2. Customize using the available options in the Edit Landmark window:
1. Delete – Delete selected landmark
2. Undo – Undo last action
3. Redo – Redo last action
4. Move – Enables user to manually move landmark in display screen
5. Show/Hide – Show or hide selected landmark in display screens
6. Show/Hide Text – Show or hide landmark name in display screens
7. Change Color – Change color of landmark
8. Edit Name – Edit name of landmark
9. Scale – Edit the size of landmark
10. Rotate – Rotate landmark by holding the left mouse button and moving cursor
NOTE: Lesions, CS Ref, Apex, RVOT and RAA may not be rotated
11. Show/Hide All LM – Show or hide all landmarks in display screens
12. Show/Hide All Text – Show or hide all landmark names in display screens
NOTE: Lesion text is hidden by default. The system can display text for up to 300
lesions when this option is turned on.

Closing the Procedure

After the clinical procedure, the procedure can be closed using the [Close] button in the Procedure tab. Closing a procedure saves it on
the system's hard drive for further viewing or archive operations.
Alternatively, click the [Exit] button to exit the application and return to the Clinical Screen. The patient data can be archived there or the
system can be shut down by following the proper shutdown procedure.

69
Archive Utility
MediGuide™ Technology users may archive and import study data using the Archive utility. Data may be archived to or imported from the
following sources - a hospital PACS server, a network drive, a USB device, or a CD/DVD drive.

Figure 85. Archive Utility Interface

The following tasks may be performed in the Archive utility:

 Archive Study – Store MediGuide™ Technology studies
 Archive Media – Store screenshots and videos taken during MediGuide™ Technology studies
 Import Study - Import MediGuide™ Technology studies
NOTE: Must be logged in as an SJM-Expert user to import a study. When logged in as a Clinical user, the Import Study screen
will not appear in the Archive utility.
 Import Model/Map - Import 3D models created from the segmentation of CT or MR images
Click the [Archive] button in the bottom left corner of any launcher screen to open the Archive utility. When opened from a launcher
screen, all archive/import tasks may be performed - Archive Study, Archive Media, Import Study, and Import Model/Map.
The Archive utility may also be opened from the Cardiac Navigation or Cardiac Navigation with Angio Survey™ Application by clicking on
the [Import CT/MR] button in the Procedure tab or the Load Modality dialog window. When the Archive utility is opened from the Cardiac
Navigation or Cardiac Navigation with Angio Survey™ Application, only the Import Model/Map screen will be available.
Archive Study
To avoid running out of disk space on the MediGuide™ Technology local hard drive, it is recommended that studies are frequently
archived and deleted from the local hard drive.
1. Navigate to the Archive Study screen in the Archive utility. A list of MediGuide™ Technology studies stored on the hard drive will
appear.
2. Select one or more studies from the list to archive.
3. Select the desired Archive Destination in the bottom left corner of the screen.
NOTE: Enable the Delete the selected studies from the local drive after successful archiving checkbox to remove the study
from the local hard drive after archiving.
4. Click the [Archive] button.
To delete a study from the local hard drive without archiving, select the study in the Archive Study screen and click the [Delete selected
studies without archiving] button.

70
Archive Media
1. Navigate to the Archive Media screen in the Archive utility. A list of MediGuide™ Technology studies stored on the hard drive with
videos/screenshots will appear.
2. Select the study that contains the media to be archived. A preview window on the right side of the screen will show the videos and
screenshots from the study.
3. Select the desired Archive Destination in the bottom left corner of the screen.
4. Click the [Archive] button. All media from the selected study will be archived.

Import Study
NOTE: This feature is only available when logged in as an SJM-Expert user.
1. Navigate to the Import Study screen in the Archive utility.
2. Ensure the EPS modality is selected by enabling the EPS checkbox in the upper right corner of the screen.
NOTE: Some PACS servers may not support EPS modality type and may modify that field when a MediGuide™ Technology
study is stored. If a query with EPS modality type checked does not return the expected MediGuide™ Technology study in the
query result, clear all modality checkboxes and try the query again.
3. Select the external source that the study will be imported from in the dropdown menu in the upper left corner of the screen.
NOTE: The Retrieval History will display the most recent files imported from the hospital PACS server.
4. Find the study by browsing or performing a query (the external source selected will determine which option(s) are available):
Browse – Browse through the files/directories listed in the screen to find study.
Perform a Query - Specify the search criteria and then click the [Query] button to search.
NOTE: The asterisk (*) may be used as a wildcard, if supported by your PACS server.
- At least one of the following must be entered: Patient ID, Patient Name, Accession Number, or Study
- Inputs into the Patient Name and Referring Physician field must be entered using the following format:
"LastName^FirstName".
If the expected record is not returned, try using a wildcard search: "LastName^FirstName*", "LastName^*", "Last Name*", or
"*^FirstName"
5. Select the desired study and click the [Import Study] button.
NOTE: If the PACS server supports Series level retrieval, select the series with Series Description "Study Data".
6. If only one study is retrieved, the study will be imported. If multiple studies are retrieved, a study selection window will be displayed.
Select the desired study, and then click on the [Continue . . .] button to import the study into the MediGuide™ System.
NOTE: Only one study can be imported at a time.
7. If the selected study already exists on the local hard drive, a warning will be displayed: This study already exists on the system.
Overwrite? Select [Yes] to replace the existing study with the newly-imported study.
8. When the import is complete, the Archive utility will close.

Import Model/Map
1. Navigate to the Import Model/Map screen in the Archive utility.
2. Select the external source that the model will be imported from in the dropdown menu in the upper left corner of the screen.
NOTE: The Retrieval History will display the most recent files imported from the hospital PACs server.
3. Find the model file by browsing or performing a query (the external source selected will determine which option(s) are available):
Browse – Browse through the files/directories listed in the screen to find model.
Perform a Query - Specify the search criteria and then click the [Query] button to search.
NOTE: The asterisk (*) may be used as a wildcard, if supported by your PACS server.
- At least one of the following must be entered: Patient ID, Patient Name, Accession Number, or Study
- Inputs into the Patient Name and Referring Physician field must be entered using the following format:
"LastName^FirstName".
If the expected record is not returned, try using a wildcard search: "LastName^FirstName*", "LastName^*", "Last Name*", or
"*^FirstName"
4. Select the model and click the [Retrieve] button or the [Select] button (whichever button appears in the bottom of the screen).
5. After successful retrieval or selection, all retrieved or selected models are listed for in a preview window. Select the desired model
and click the [Load Model/Map] button.

71
Archive Troubleshooting
Settings icon – Click to open the Settings window
NOTE: The Settings icon is will only available to SJM-Expert users. This icon will not appear when logged in as a
Clinical user.

Log icon – Click to open the Log window

Log
The Log is used to troubleshoot communication-related issues. Access the Log by clicking on the Log icon.
 Log Level – The Log Level determines the type of information that is included in the Log. The following levels are available:
- INFO – (default) User Operation (Query, Retrieve, Criteria, Operation Status).
- WARNING – General warning messages in addition to INFO.
- DEBUG – General debug messages in addition to INFO, WARNING
- TRACE – Trace messages in addition to INFO, WARNING, DEBUG.
The default Log Level is INFO. The Log Level may be set higher. However, in most cases DEBUG is sufficient to debug any
communication related issues. The Log Level will stay in effect until the Archive utility is closed, or until it is changed.
NOTE: Log messages may be truncated. Click on [Log History] to load the untruncated log entries.
 MB – This text box may be used to specify the megabytes of log messages from the end of the file to load.
 [Log History] – When the Log window is displayed, only the tail of the log file is displayed. The user can load extra log history by
clicking [Log History].
 [Clear Screen] – Click this button to clear the entire log text window.
 [Refresh] – Click this button to load the newly added log entry to the log file.
 Close – Click the [Close] button to close the Log window.
Query Failed
Follow these steps to troubleshoot a failed query:
1. Check that the Ethernet cable is properly connected.
2. Open the Settings window and click on the PACS Servers tab.
3. Make sure the Q/R checkbox is checked.
4. Click [Test Connection] to verify the connection. If the connection is successful, skip steps 5 and 6.
5. Check that the AE Title, IP Address, and Port Number are correctly typed. If they are not correct, correctly type the parameters and
click [Test Connection] to verify the connection.
6. If the PACS server was moved, check with the PACS Administrator to verify that the AE Title, IP Address, and Port Number are still
valid. If they are not valid, correct the parameters and go to step 5.
7. Do a simple test query. If the test query is not successful, go to step 9.
8. Do the original query. If the original query is successful, stop here.
9. Increase the Log Level to DEBUG and perform the original query.
10. Call Technical Support to report the problem. Be sure to have logs available.

Retrieve Failed
1. Open the Settings window.
2. Have the PACS Administrator verify that the MediGuide™ System is properly registered and that the AE Title, IP Address, and Port
Number are correct. If more than one MediGuide™ System is in use, each must be properly registered and have a unique AE Title.
3. Verify that the Timeout setting is sufficient and increase it if needed.
4. Have the PACS Administrator perform an echo test from the server to the MediGuide™ System. Make sure that this operation is
successful before proceeding.
5. Check the Log for the presence of disk IO error messages. If the error is not present, skip step 6.
6. Open the Settings window and click on the History Management tab. Click the [Edit] button and then click the [Delete Retrieval
History] button. At the prompt, Delete Retrieval History? select Yes.
7. Retry the retrieve. If the retrieve is successful, stop here.
8. Restart the Archive utility and retry the retrieve. If the retrieve is successful, stop here.

72
9. Reboot the PACS server, and retry the retrieve. If the retrieve is successful, stop here.
10. Increase the Log Level to DEBUG and perform the original retrieve.
11. Call Technical Support to report the problem. Be sure to have logs available.

Storage Failed
1. Open the Settings window and click on the PACS Servers tab.
2. Make sure that the Storage checkbox is checked.
3. If a pre-processing error occurs, the disk space may be full. Follow step 6 of the "Retrieve Failed" section to clean the disk and try
storage again.
4. If a transmission error occurs, follow steps 1 to 2 and steps 4 to 6 of the "Query Failed" section.
5. Repeat the original storage. If it is successful, stop here.
6. Increase the Log Level to DEBUG and perform the original storage.
7. Call Technical Support to report the problem. Be sure to have logs available.

Storage Commitment Failed

1. Open the Settings window and click on the PACS Server tab.
2. Confirm that the Storage Commitment setting (SYNCHRONOUS, ASYNCHRONOUS, NOT SUPPORTED) matches the setting on the
PACS server.
3. If ASYNCHRONOUS has been selected for Storage Commitment, confirm that the Port Number setting is registered correctly on the
PACS server.
4. If ASYNCHRONOUS has been selected for Storage Commitment, the Archive utility does not time out waiting for the PACS server
response. Click on [Cancel] button on the Store in Progress bar to stop the storage operation.
5. The message Storage Commitment not attempted occurs when the Storage Commitment option on the PACS Server Settings
window is set to Not Supported.
6. The message Storage Commitment request failed occurs when the Storage Commitment request is rejected by the PACS server or
there is no response from the PACS server before timeout occurs. Try increasing the timeout.
7. If a Committed Partial error is received, contact the PACS Administrator for assistance.
8. If Storage Commitment continues to fail, collect log and call Technical Support to report the problem.

Media Export
Videos and screenshots may be exported to a USB device, CD/DVD, or network location:
1. Click the [Media Export] button on one of the launcher screens. The Media Export window will be displayed.
2. Within the Media Export window, select a study.
3. Select the video/screenshot from the study to be exported.
4. Click the [Save] button.
5. When prompted, choose the location to save the file to and click [OK].

73
Figure 86. Media Export Interface

74
User-Level Maintenance
NOTE: Maintaining the system on a periodic basis, both by the user and/or by St. Jude Medical personnel, is crucial for
ensuring system performance.
It is the responsibility of the user to perform the following maintenance operations:
 Maintenance
 Data Management
All other maintenance operations should be performed by a qualified technician only.
CAUTION: Do not perform any kind of maintenance to the system in the presence of explosive materials.

Maintenance
PRS Maintenance
The PRS is intended for multiple uses. After each use, it must be cleaned and maintained as follows:
 Clean the PRS (not including its connector) by wiping it with a cloth saturated with 70% alcohol solution.
 Inspect the PRS and replace if it is damaged.
 At the end of the day, disconnect the PRS and coil and store it in MediGuide™ Connect side panel.
WARNING: It is recommended to clean the PRS with a cloth saturated with 2% glutaraldehyde solution (such as Cidex 10
solution) once a month.

General Cleaning of the MediGuide™ Connect, MediGuide™ Cath Connect, MediGuide™ Cath Connect, Sensor
Enabled™ and MTA
If needed, clean the MediGuide™ Connect, MediGuide™ Cath Connect, MediGuide™ Cath Connect, Sensor Enabled™ and MTA by
wiping them gently with a cloth saturated with 70% alcohol.

Data Management
The Clinical Screen includes an indicator of disk space as shown in the next figure.

Figure 87. Sufficient disk space

When the disk space is low, the indicator will display a warning as shown in the next figure.

Figure 88.

NOTE: Proceeding without freeing up disk space will result in automatic deletion of the data of the earliest procedure on the
disk.

Tools Window Description

The [Tools] button opens the Tools window (refer to the next figure). It provides the technician's tools options for the St. Jude Medical
operator only.

10
Cidex is a trademark of Johnson & Johnson.

75
Figure 89. Tools Window

Table 11. Utility Button Descriptions

Utility name Operation Description Use

Patient Info. Displays patient data Patient data verification during procedure
Filter Comp. Cine Removes invalidated cines Acts as a toggle button. When active, eliminates the
non-compensated cines from the Cine List
MCA Snap Shot Saves real time hardware status As part of troubleshooting
Show Error Bar Shows error message history statically on Secondary System problem troubleshooting
Display.

Filter Comp. Cine

This feature filters out invalid cines from the Cine List so that only the valid cines will be visible. The [Filter Comp. Cine] button will
become enabled when at least one valid cine has been recorded. Turn this feature on by selecting this button. When this feature is
activated, invalid cines will become hidden in the Cine List. In addition, any invalid cines recorded while this feature is activated will not
appear in the Cine List.
Turn off this feature by unselecting the [Filter Comp. Cine] button. When the feature is turned off, all previously recorded invalid cines will
become visible again in the Cine List. In addition, any invalid cines that were recorded while the feature was activated will now be visible
in the Cine List.

Show Error Bar

The [Tools] window offers the option to display a static error log history at any time on the Secondary Display. The error log history will
contain any errors recorded during the patient procedure in process. Displaying the Error Log History window is recommended whenever
the system status is not clear and specifically under the following circumstances:
 If the [New] button is not available
 At the end of Siemens bi-plane mode,
 At the end of Siemens bypass mode,
 After the use of the non-gMPS Exam_Set in the Siemens imagining system,
 After the magnetic field of the system had been turned off and is being turned on again, by the user
The Error Log History window can be called up at any time during a procedure from the Primary Display.
To display the error log:
1. In the Procedure tab, select the [Tools] button.
2. The Tools window is displayed containing the [Show Error Bar] button.
3. Select the [Show Error Bar] button.
4. The Error Log History window is shown on the Secondary Display.
5. If any other error messages are open, the Error Log History window will supersede all other error messages. A scroll option is
provided for the user's convenience.

76
Figure 90. Error Log History Window

77
Feedback
If you have any comments, contact St. Jude Medical Technical Support.

St. Jude Medical

One St. Jude Medical Drive
St. Paul, MN
55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com

St. Jude Medical Coordination Center BVBA

The Corporate Center
DaVincilaan 11 Box F1
1935 Zaventum
Belguim
+32 2 774 68 11
sjm.com

In some cases, St. Jude Medical may use on-site satisfaction survey forms. Please help us by completing the form with all relevant details.

78
Safety and Compliance Standards
The MediGuide™ Technology in conjunction with any MediGuide Enabled™/Sensor Enabled™ device must meet the safety and
compliance standards and requirements listed below.
General Safety Description
EN 60601-1 (2nd and 3rd Edition) (+amnd. 1,2) General Safety requirements for Medical Electrical Equipment
Risk Management Description
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices.
Magnetic Field Safety Description
ICNIRP Guidelines 1998 Guidelines for limiting exposure to time-varying electric, magnetic and
electromagnetic fields (up to 300 GHz)
ANSI/IEEE C95.1-1999 Standard for safety levels with respect to human exposure to radio-frequency
electromagnetic fields, 3 kHz to 300 GHz
ACGHI (2004 edition) Threshold limit values for chemical substances and physical agents.
EMC Compliance Description
EN 60601-1-2 (2nd and 3rd Edition) Electromagnetic Compatibility - Requirements and Tests

79
Electromagnetic Emissions & Immunity
Guidance and Manufacturer’s Declaration - Electromagnetic Emissions
MediGuide™ Technology is intended for use in the electromagnetic environment specified below. The customer or the user of
MediGuide™ Technology should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions Group 1 MediGuide™ Technology uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF emissions Class A MediGuide™ Technology is suitable for use in all establishments other than
CISPR 11 domestic and those directly connected to low-voltage power supply network,
which supplies buildings used for domestic purposes.
Harmonic emissions Not applicable
IEC 61000-3-2
Voltage fluctuations/ Not applicable
flicker emissions
IEC 61000-3-3

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity

MediGuide™ Technology is intended for use in the electromagnetic environment specified below. The customer or the user of
MediGuide™ Technology should assure that it is used in such an environment.
Immunity Test IEC 60601 Compliance Level Electromagnetic Environment -
Test Level Guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile.
(ESD) ±8 kV air ±8 kV air If floors are covered with synthetic material, the
IEC 61000-4-2 relative humidity should be at least 30%.
Electrical fast ±2 kV for power supply lines ±2 kV for power supply Mains power quality should be that of a typical
transient/burst ±1 kV for input/output lines lines commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/output
lines
Surge ±1 kV line(s) to line(s) ±1 kV differential mode Mains power quality should be that of a typical
IEC 61000-4-5 ±2 kV line(s) to earth ±2 kV common mode commercial or hospital environment.
Voltage dips, short <5% UT <5% UT Mains power quality should be that of a typical
interruptions and voltage (>95% dip in UT) (>95% dip in UT) commercial or hospital environment.
variations on power Continued operation, during power mains
for 0.5 cycle for 0.5 cycle
supply input lines interruptions, is not required for MediGuide™
IEC 61000-4-11 Technology.
40% UT 40% UT
(60% dip in UT) (60% dip in UT)
for 5 cycles for 5 cycles

70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles

<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 s for 5 s
Power frequency (50/60 3 A/m 3 A/m in X,Y,Z The power frequency magnetic field should be
Hz) measured in the intended installation location to
magnetic field assure that it is sufficiently low.
IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.

80
Immunity Test IEC 60601 Compliance Electromagnetic Environment - Guidance
Test Level Level
Conducted RF 3 Vrms 3 Vrms Portable and mobile RF communications
IEC 61000-4-6 150kHz to 80 MHz [V1=3] equipment should be used no closer to any part
of MediGuide™ Technology, including cables,
than the recommended separation distance
Radiated RF 3 V/m 3 V/m calculated from the equation applicable to the
IEC 61000-4-3 80 MHz to 2.5 GHz [E1=3] frequency of the transmitter.

Recommended separation distance

d = [3.5/E1]·√P
d = [12/E1]·√P 80 MHz to 800 MHz
d = [23/E1]·√P 800 MHz to 2.5 GHz

where P is the maximum output power rating of

the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a
should be less than the compliance level in each
frequency range.b

Interference may occur in the vicinity of

equipment marked with the following symbol:

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which MediGuide™ Technology is used exceeds the applicable RF compliance level above, MediGuide™ Technology should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating MediGuide™ Technology.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

81
82

St. Jude Medical
One St. Jude Medical Drive
St. Paul, MN 55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com
*600005265*
Australian Sponsor:
St. Jude Medical Australia Pty. Limited
17 Orion Road
St. Jude Medical Lane Cove NSW 2066
Coordination Center BVBA Australia
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
2016-12
ARTUS600005265 A