St. Jude Medical MediGuide MG1000 User manual

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 f
rom 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 auth
orized 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
Reference Sensor (PRS)
Patient Reference Sensor/Motion Sensor; herein referred to as 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 EnPulse1E2SR01 Pacemaker
-Medtronic Marquis2VR 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).
1EnPulse is a trademark of Medtronic.
2Marquis 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
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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
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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
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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 DICOM3-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
3DICOM is a trademark of the National Electrical Manufacturers Association.
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