BWI F58 CARTO 3 System and the EP Lab/Study

equipment in the Control Room

- 3D mapping system - recording system - SMARTABLATE Generator remote - Pacing Stimulator - Fluoroscopy monitor

EP fellow

- EP trainee - scrubs in with physician - measures, documents, and records body surface and intracardiac EGMs - perform pacing maneuvers

components of the CARTO 3 System Tower

- Patient Interface Unit (PIU) - Power Supply - Location Pad

anesthesiologist

- administers anesthesia - monitors vitals - performs intubation - manages patients airway

FAM

- allows geometry to be built as fast as physician can move Sensor-based catheter around chamber - applies a special volumetric algorithm to build geometry unique to each patients endocardial anatomy - every location the catheter visits is represented by orange 3D geometry; a gray exterior is created and represents the endocardial surface

C-suite

- approve capital budgets and spending - oversee hospital business decisions

PbP Mapping

- built by moving a Sensor-based catheter to different places in the heart and acquiring points, which contain location and electrical data - areas between points are created through interpolation

CARTO 3 Hybrid technology

- combines the accuracy of magnetic location with a non-sensor based catheter of current-based technology - as the physician navigates a sensor-based catheter (i.e. ablation catheter), every location the catheter visits is stored along with the Current Ratio of each electrode on the catheter - the system links each Current Ratio with its respective magnetic X,Y,Z location, resulting in a Visualization Matrix - able to visualize Non-Sensor based catheters because the system matches its electrodes specific Current Ratios to the Current Ratios and XYZ location previously defined with a Sensor-Based catheter

BWI rep

- creates map geometry - helps physicians interpret map - expert on BWI products

lab manager

- ensures staff are properly trained - manages EP budget - creates lab assignments - schedules cases

equipment in the Procedure Room

- fluoroscopy machine - Monitor Bank - patient table - BOOM

scrub nurse / tech

- preps patient - assists physician - protects sterile field - maneuvers patient table

EP physician

- responsible for everything that happens during a procedure - manages EP staff - prescribes medications - monitors vitals - teaches fellow - performs EP study

radiology tech

- sets up fluoroscopy equipment - steps on fluoroscopy pedal - adjusts fluoroscopy images during the case

impedance-based technology

- several patches placed on patient body (patches are in pairs) - single-frequency current is sent from one patch to its pair and a baseline impedance is measured between patches - when a catheter is inserted between the patches, its creates additional impedance; this change in impedance is measures and allows for visualization of the catheter on the mapping system

monitor tech

- sits at recording system; measures, documents, records, interprets - performs pacing maneuvers as ordered by physician

current-based technology

- system generates a small current and sends it to the electrodes of all catheters - on the catheter, EACH electrode emits a current with its OWN unique frequency, which is then collected by the patches - when the patches collect this information, they are also calculating the strength of the current each patch receives - average of the currents that all 6 patches receive is unique to each electrodes location --> Current Ratio

magnetic technology

- uses positions of back patches and the Location Pad relative to each other to calculate a Virtual Location Reference or BCS - system monitors the BCS for any changes throughout the study - when a Sensor-based catheter is inserted into the patient's heart (or Mapping Zone), the sensor in the catheter measures the strength of the magnetic field based off its distance from each coil on the Location Pad - this allows the system to identify catheter tip location and orientation in 3D space

circulating nurse

- verify patient - proper prep - monitor vital signs - administer meds - ready equipment - status updates to recovery room

components of the Workstation

- workstation - DVI cable - USB cable

3 required components of current-based technology

1. Back patches 2. Chest patches 3. Any catheter with electrodes

3 elements of magnetic technolgoy:

1. Location Pad 2. 3 Back Patches 3. Sensor-based catheter

two ways to build 3D anatomical maps

1. Point-by-point Mapping (PbP) 2. Fast Anatomical Mapping

rooms in the EP Lab

1. Procedure Room 2. Control Room

advantages of the CARTO 3 hybrid technology

1. allows visualization of any catheter with electrodes 2. creates a linear field 3. is not effected by biological changes 4. very accurate

phases of the diagnostic portion of EP study

1. baseline conduction system measurements (tells the physician a story about the patients conduction system) 2. pacing protocol (gain more info about patient's health and conduction system) 3. arrhythmia induction 4. drug challenge (if inducing arrhythmia with pacing does not work)

disadvantages of impedance-based technology

1. creates a non-linear field (part of the catheter will appear distorted in certain areas) 2. sensitive to biological/physical changes in the patient (i.e. fluid delivery, perspiration) 3. impedance measurements change with each catheter inserted

three mapping technologies

1. impedance-based technology 2. magnetic technology 3. current-based technology

disadvantages of magnetic technology

1. only supports NAV-based catheters (if a catheter does not have a magnetic sensor, it will not be visualized on the system)

steps of an EP study

1. patch placement 2. obtain sterile field 3. begin procedure (common: via femoral vein) 4. diagnostic portion 5. therapeutic portion 6. post-testing

CARTO 3 system set-up sequency

1. plug PIU to Power Source 2. plug Workstation into Power Source 3. connect Fiberoptic from PIU to Workstation 4. connect DVI cable from Workstation to secondary monitor 5. connect secondary monitor USB cable 6. place Location Pad under table 7. turn on PIU power 8. turn on Workstation power 9. connect ECG Out cable 10. connect IOIOI 1 from SMARTABLATE Generator to recording system 11. connect IOIOI 2 from SMARTABLATE Generator to Workstation 12. connect SMARTABLATE Remote cable from back of generator to remote 13. connect SMARTABLATE Foot Pedal cable back to generator 14. connect SMARTABLATE Pump cable from back of generator to back of SMARTABLATE Pump 15. power on SMARTABLATE 16. power on SMARTABLATE remote 17. connect Pacing Stim cable to PIU 18. connect SMARTALATE System cable to RF port on PIU 19. connect ablation cable to catheter 20. connect ablation cable to Red MAP Port on PIU 21. connect CS cable to catheter 22. connect CS cable to Blue Port on PIU 23. connect PENTARAY Eco Catheter cable to catheter 24. connect PENTARAY Eco Catheter adapter to cable 25. connect PENTARAY Eco Catheter adapter to 20A Blue Port on PIU 26. connect Pin Box to 20B Blue Port on PIU 27. connect SOUNDSTAR Eco Catheter to cable 28. connect SOUNDSTAR cable to Green Port on PIU 29. connect body surface ECG In cable to front of PIU 30. connect grounding pad to SMARTABLATE Generator 31. connect grounding pad to patient 32. connect green patches to patient back 33. connect ECG leads to patient front 34. connect yellow patches to patient front

System power up sequence

1. power on PIU 2. power on Workstation 3. power on SMARTABLATE Generator 4. power on SMARTABLATE Remote 5. power on SMARTABLATE Pump

advantages of magnetic technology

1. provides high level of accuracy 2. not affected by biological changes within patient

advantages of impedance-based technology

1. you can visualize any catheter

by providing X, Y, Z, Roll, Pitch, Yaw measurements, the CARTO 3 System provides ____________________

6 degrees of freedom

magnetic- + current-based technology =

Advanced Current Location (ACL)

BCS stands for

Body Coordinate System

Virtual Location Reference =

Body Coordinate System (BCS)

FAM stands for

Fast Anatomical Mapping

magnetic technology shows catheter tip orientation via...

Roll, Pitch, Yaw

the CARTO 3 hybrid technology allows for the creation of a _________________________

Visualization Matrix

magnetic technology shows catheter tip location on....

XYZ plane

fluoroscopy machine

allows EP to visualize anatomy and catheters in real time

Foot Pedal

allows user to control on/off of RF delivery by pressing/releasing

SMARTABLATE Pump cable

connects RF generator to pump; allows communication between the two

IOIOI 1

connects SMARTABLATE Generator to recording system

Remote cable

connects SMARTABLATE remote to RF generator; allows communication between the two

Fiberoptic

connects Workstation to PIU; transfers data between the two

SMARTABLATE Generator Cable

connects the PIU to the RF generator; transfers data between the two

IOIOI 2

connects the SMARTABLATE Generator to CARTO 3 System

DVI Cable

connects the secondary monitor to the CARTO 3 System Workstation; allows primary monitor image to display on secondary monitor in real time

Patch Unit

connects to patches on patient used for mapping; transfers data from patches to the PIU

3D mapping system

creates detailed 3D anatomical map with the use of X-rays

Pitch

degree of slope of catheter tip

Pacing Stimulator

delivers electrical impulses to the heart to see how it responds; pacing helps diagnose arrhythmias

recording system

displays and records heart activity during an EP procedures; contains ECGs and EGMs

CARTO 3 System

electro-anatomical mapping system that creates real time, 3D maps of the inside of a patients heart; also shows the location of the catheters in the hearts' chambers

Workstation

gathers data transmitted from the PIU; creates 3D electro-anatomical map of the heart during an EP study

Location Pad

generates a low amplitude magnetic field to enable accurate location data; placed under patient table

6 degrees of freedom

highly precise measurements of a catheter in space and orientation within the heart

Patient Interface Unit (PIU)

interfaces catheters and other equipment; processing unit for implementing all real-time location and ECG calculations

Patches

measures high frequency, low power current emitted from each catheter electrode connected to the system; determines the initial Body Coordinate System (BCS) based on the three back patches and their positions relative to each other and the Location Pad

Fluoroscopy monitor

monitors total dose and time of radiation exposure

a physician must _________________________________ in order to increase the Visualization Matrix

move a Sensor-based catheter to areas for a long enough period of time; this allows Non-Sensor based catheters to be visualized

USB cable

powers the DVI cable that connects to the secondary monitor; supplements power for the DVI fiberoptic cable

SMARTABLATE Generator remote

provides full control of RF ablation

Roll

rotation of the catheter tip

patient table

serves as a sterile field for patient and equipment

Ya

side-to-side orientation of catheter tip

Power Supply

supplies electrical power; provides surge protection to the PIU

ECG Out

transfers body surface ECG signals from PIU to recording system

ECG In

transfers the heart rhythm data from the patient to the PIU

IC Out

transmits intracardiac signals from the PIU to recording system

components of post-testing

validation of therapy; post-conduction system measurements

BOOM

where PIU, SMARTABLATE Generator, and Recording System Amplifier equipment are location; provides grounding area for electrical equipment (eliminates noise)

Monitor Bank

where the physician and staff view all information during the case