INTELLAMAP ORION™ Mapping Catheter

INTENDED USE/INDICATIONS FOR USE

The IntellaMap Orion Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

CONTRAINDICATIONS

The IntellaMap Orion Catheter should not be used:

• in patients who are not candidates for transvascular catheter procedures.
• in patients with a hypercoagulable state or who cannot tolerate heparin or an acceptable alternative to achieve adequate anticoagulation therapy.
• in patients with prosthetic or stenotic valves, in the chamber where the prosthetic or stenotic valve reside.
• in patients with active systemic infection.
• in pediatric patients.
• in pregnant and/or nursing patients.
• for radio frequency (RF) ablation.
• near or inside an MRI machine.
• in patients with conditions where insertion into or manipulation in the cardiac chambers is unsafe as these conditions (e.g., presence of intracardiac thrombus or myxoma, history of recent cardiac surgery with atriotomy, etc.) may increase the risk of systemic embolism or cardiac perforation.
• in patients who have vena cava embolic protection filter devices and/or known femoral thrombus who require catheter insertion from the femoral approach.
• in patients who are hemodynamically unstable.
• via transseptal approach in patients with intraatrial baffle or foramen ovale patches.
• via retrograde transaortic approach in patients with a prosthetic aortic valve.
• near or inside an MRI machine.
• Do not use this device:
  • with a long sheath or a short introducer < 8.5 F
  • in the coronary vasculature

WARNINGS

• To avoid causing cardiac damage, perforation, or tamponade, do not operate the catheter against resistance. If resistance is felt during advancement, retraction, articulation, deployment or un-deployment, stop and evaluate device location under fluoroscopy.
• Do not advance or retract the catheter through a sheath when deployed or articulated. Doing so may compromise the physical integrity of the catheter and cause patient injury.
• In order to reduce the risk of clot formation:
  • Maintain an activated clotting time (ACT) of greater than 300 seconds at all times during use of the catheter, and continuously flush the electrode array with saline via the irrigation port at the proximal end.
• Cardiac mapping and ablation procedures should be performed only by physicians thoroughly trained in invasive cardiology and in the techniques of catheter mapping and RF powered ablation, and in the specific approach to be used, in a fullyequipped electrophysiology lab.
• Before using, inspect the IntellaMap Orion Catheter for any defects or physical damage, including electrical insulation on the cables and the catheter shaft that, if used, may cause patient and/or user injury. Do not use defective or damaged devices. Replace damaged equipment if necessary. No modification of this equipment is allowed.
• If a broken, fractured, or open spline is identified during the manipulation of the IntellaMap Orion Catheter, remove the catheter immediately and replace it to reduce the risk of embolism and/or pericardial effusion, perforation, or tamponade.
• If the visibility of the IntellaMap Orion Catheter is compromised for any reason, the user should stop and not resume mapping until catheter visibility is established in order to prevent patient injuries such as perforation, heart block and injury to adjacent structures.
• Contents are supplied STERILE using an Ethylene Oxide (EO) process and should be used by the “Use By” date on the device package. Do not use the device if past the “Use By” date. Do not use if sterile barrier is damaged as use of non-sterile devices may result in patient injury. If damage is found, call your Boston Scientific representative.
• Before insertion, ensure that the IntellaMap Orion Catheter passes smoothly through the guiding sheath without the use of excessive force to avoid catheter entrapment/entanglement and reduce the risk of a delay or interruption in the procedure.
• In order to prevent catheter vascular entrapment, use a sheath that is long enough to extend past the inferior vena cavae (IVC) and always keep the IntellaMap Orion Catheter inside the sheath when advancing or withdrawing the catheter in the vessel(s).
• Electromagnetic Interference (EMI) from any source during normal operation may adversely affect the visualization and tracking of the catheter during the procedure, which can cause patient injuries such as perforation, heart block and injury to adjacent structures.
• Ensure that the cable/catheter connection remains dry throughout the procedure in order to prevent electric shock or other patient injuries as well as to prevent loss of device function.
• Electrodes and stimulating devices can provide paths of high frequency current. The risk of burns can be reduced but not eliminated by placing the electrodes as far away as possible from the ablation site and the Dispersive Pad. Protective impedances may reduce the risk of burns and permit continuous monitoring of the Electrocardiogram (ECG) during energy delivery.
• When using the IntellaMap Orion Catheter with a steerable guiding introducer sheath, ensure under fluoroscopy that the guiding introducer sheath distal end is straight or in neutral position, and, if necessary, only minimally curved prior to advancing or retracting the catheter through the sheath to avoid catheter entrapment/entanglement and reduce the risk of damage to cardiac tissue and/or structure.
• Do not advance or retract the catheter through a sheath when deployed or articulated. Doing so may compromise the physical integrity of the catheter and cause patient injury.
• The use of this device in conjunction with RF ablation, as part of the diagnosis and treatment of arrhythmias, may pose an increased risk of adverse events, such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion.
• Always fully undeploy the catheter basket prior to removal from the patient. Use visualization (such as fluoroscopy) to verify undeployment. Inadvertent damage to cardiac tissue/structure during withdrawal of the catheter basket may result in embolism, perforation, tamponade and in rare cases, death.
• Fibrin may accumulate in or on the sheath/catheter basket assembly during the procedure, which could result in embolism.
• Prior to insertion into vasculature, ensure removal of all air from the catheter lumen; use a pressured saline bag to flush saline through the catheter shaft and electrode array to reduce risk of embolism.
• Electrical recording or stimulation equipment must be isolated. Current leakage from any electrical equipment that is connected to the patient must not exceed 10 microamps for intracardiac electrodes.
• Care must be taken to ensure that any equipment used in connection with the BSC catheters be type CF, be defibrillation proof, meet IEC 60601-1 electrical
  safety requirements, and comply with all local regulatory requirements for specified intended use to reduce the potential risk of inadvertent electrical shock.
• Always move the articulation control level to its neutral position to straighten the catheter prior to removal from the patient in order to prevent entanglement/ entrapment within cardiac valves and/or other devices that may result in valvular injury, myocardial trauma and/or may require additional medical/surgical intervention.
• Stimulation of cardiac tissues caused by pacing stimulus and/or RF energy may lead to inadvertent induction of arrhythmias. These arrhythmias may require defibrillation that could also result in skin burns.
• Warnings for patients with implantable pacemakers and Implantable Cardioverter/Defibrillators (ICDs):
  • Follow manufacturer guidelines for device programming prior to procedure. Temporary programming changes, such as changing to non-tracking mode or disabling tachy therapy, may be necessary prior to pacing maneuvers, arrhythmia induction or RF energy delivery.
  •  Have temporary external sources of pacing and defibrillation available.
  •  Fluoroscopic guidance or appropriate imaging and care must be taken during catheter advancement, manipulation, and withdrawal to avoid lead dislodgment.
  •  Perform a complete analysis of the implanted device and leads (sensing, impedance, thresholds) post procedure to confirm lead integrity and device function.
  •  Restore permanent device programming post procedure, if applicable.
• Do not apply RF energy on an ablation catheter that is in direct contact with the electrodes on the IntellaMap Orion Catheter, as this may alter the function of the catheter and may lead to thrombus, coagulum, or char formation that may result in embolism.
• To avoid causing cardiac damage, perforation, or tamponade, do not operate the catheter against resistance. If resistance is felt during advancement, retraction, articulation, deployment or undeployment, stop and evaluate device location under fluoroscopy.
• Catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures. The potential for catheter entrapment may be increased when the catheter is overtorqued and/or positioned in the chordae tendineae. The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.
• Catheter mapping and ablation procedures present the potential for significant radiation exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the radiation beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Careful consideration must therefore be given for this use of the device in pregnant women and/or prepubescent children.
• Excessive curves or kinking of the catheter may damage internal wires and components This damage may affect catheter performance and may cause patient injury.
• Manual bending and/or twisting of the distal curve and/or basket can damage the electrodes or electronic circuit, steering mechanism, and irrigation lumens and may cause catheter failure and patient injury.
• Use both fluoroscopy, or other visualization technique such as echocardiography, and electrograms to monitor the advancement of the catheter to the area of the endocardium under investigation and for undeployment and removal of the catheter to avoid conduction pathway injury, cardiac perforation or tamponade.
• Patients undergoing left sided ablation procedures should be closely monitored during and post procedure for clinical manifestations of infarction, pulmonary vein injury, nerve damage, embolism and/or atrial esophageal fistula.
• Patients with hemodynamic instability or cardiogenic shock are at increased risk for life-threatening adverse events and extreme caution must be taken.
• Guiding catheters and/or long introducer sheaths present the potential for thromboembolic events. Pre-flush and maintain lumen patency with heparinized intravenous infusion.
• Do not wipe the IntellaMap Orion Catheter with organic solvents such as alcohol or immerse the handle cable connector in fluids. This may result in electrical or mechanical catheter failures. It may also result in an allergic reaction for the patient.
• If there is uncertainty regarding the patient’s anticoagulation status or rhythm prior to the procedure, there should be a low threshold to perform a Transesophageal Echocardiogram (TEE) prior to the procedure to confirm absence of mural thrombus and/or thrombus in the left atrial appendage.
• Pre-procedural anticoagulation therapy is at the discretion of the physician. Administer appropriate levels of peri-procedural and post procedural anticoagulation therapy for patients undergoing right and left-sided and transseptal cardiac procedures. There is an increased risk of thromboemboli if appropriate anticoagulation levels are not maintained while the transseptal sheath and/or catheter is in the left side of the heart. However, patients with a history of thromboembolic events may require therapeutic anticoagulation therapy, pre-, during and post-ablation to reduce the incidence of major complications.
• Patients undergoing long procedures have the potential for greater anticoagulation and therefore Activated Coagulation Time (ACT) should be monitored closely due to the increased risk for bleeding from all causes / hemorrhage and/or embolism.
• The safety and/or efficacy of epicardial use of the IntellaMap Orion Catheter has not been evaluated in a clinical trial.
• The Transseptal Puncture (TSP) presents a potential risk for perforation/ tamponade; echocardiography and/or fluoroscopic images should be used to guide the transseptal puncture and a real-time arterial blood pressure monitor shouldbe applied. TSP may induce an air embolus; use proper aspiration and flushing techniques to minimize air embolus.
• Care should be used during multiple sheath/catheter exchanges through the transseptal puncture to avoid causing a residual atrial septal defect that would require repair.
• To avoid patient injury, manipulate the sheath carefully when performing the transseptal puncture especially if the patient has any of the following conditions:
  •  Enlarged aortic root
  •  Marked right atrial enlargement
  • Small left atrium
  • Marked skeletal deformity or distortion of the thoracic configuration (e.g., scoliosis)
• Any serious incident that has occurred in relation to the device should be reported to BSC and the competent authority of the Member State in which the user and/or patient is established.

PRECAUTIONS

• Electrophysiology catheters and systems are intended for use only in radiation shielded rooms due to electromagnetic compatibility requirements and other hospital safety guidelines.

ADVERSE EVENTS

Potential adverse events related to the mapping, the ablation catheter(s), and/or the interventional procedure include, but are not limited to:

• Pain or discomfort, for example:
  • Angina
  • Chest pain
  • Non-cardiovascular pain
• Cardiac arrest
• Death
• Electric shock
• Hypertension
• Hypotension
• Infection/inflammation (including pericarditis and pleuritis)/ exposure to biohazardous materials
• Edema/heart failure/pleural effusion
• Procedural related side effects, for example:
  • Allergic reaction (including anaphylaxis)
  • Genitourinary complication
  • Side effects related to medication or anesthesia
  • Radiation injury/tissue burn
  • Renal failure/insufficiency
  • Vasovagal response
  • Fluid volume overload
• Respiratory distress/insufficiency/failure/dyspnea
• Injury related to tissue damage (for example: catheter entrapment/entanglement, physical trauma, and other events that may require surgical intervention)
• Lead dislodgement
• Arrhythmia (new or exacerbated)
• Conduction pathway injury (for example: heart block, injury to sinus or AV node, etc.)
• Nerve injury, for example:
  • Phrenic nerve injury
  • Vagal nerve injury
• Gastrointestinal disorders
• Vessel trauma, including:
  • Perforation
  • Dissection
  • Coronary artery injury
  • Vasospasm
  • Occlusion
  • Hemothorax
• Cardiac trauma, for example:
  • Cardiac perforation/cardiac tamponade/pericardial effusion
  • Valvular damage
• Fistula (for example, atrio-esophageal fistula)
• PV stenosis and its symptoms, for example:
  • Cough
  • Shortness of breath
  • Fatigue
  • Hemoptysis
• Surgical and access complications, for example:
  • Hematoma/seroma
  • AV fistula
  • Bleeding or hemorrhage
  • Pseudoaneurysm
  • Pneumothorax
  • Residual atrial septal defect
• Thrombosis
• Injury due to embolism/thromboembolism/air embolism/foreign body embolism:
  • Cerebrovascular Accident (CVA)/stroke
  • Transient Ischemia Attack (TIA)
  • Myocardial infarction
  • Neurological impairment and its symptoms, for example:
    • Cognitive changes, visual disturbances, headache, motor impairment, sensory impairment, and speech impairment
  • Pulmonary embolism
  • Asymptomatic cerebral embolism

The severity and/or the frequency of these potential adverse events may vary and may result in prolonged procedure time and/or additional medical and/or surgical intervention, implantation of a permanent device such as a pacemaker, and in rare cases, may result in death.

91078319 (Rev. AB)

INTENDED USE/INDICATIONS FOR USE

The Rhythmia™ Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system's display screen.

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS AND PRECAUTIONS

• The use of the Rhythmia Mapping System in conjunction with radio frequency ablation and other medical devices, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose a risk of adverse events, such as cardiac perforation and arrhythmias (new and/or exacerbation of existing arrhythmias) that may require additional intervention.
• Do not operate the Rhythmia Mapping System near flammable anesthetics. System operation near flammable anesthetics may cause an explosion that could cause injury or death to the patient or user.
• All devices that are connected to the Rhythmia Mapping System must meet IEC 60601-1 requirements and any other relevant safety standards. When connected to other devices, the combined systems’ configuration must meet the IEC 60601-1-1 safety standards. The use of the Rhythmia™ Mapping System with accessories and devices that do not comply with relevant standards may reduce the safety of the system, cause equipment damage or system malfunction, or harm to the patient or user.
• Only stimulators that are certified for IEC 60601 should be used with the Rhythmia Mapping System.
• Do not connect life-sustaining pacing through the Rhythmia Mapping System. The system is not intended to provide life-sustaining therapy and should not be used as such. In case of need for emergency pacing, or any failure of stimulator routing, directly connect the desired paced channel to the stimulator.
• The Rhythmia Mapping System is only designed to route the stimulation signal to the desired channel. To start or stop stimulation, always use the controls on the external stimulator.
• Use the Rhythmia Mapping System only with one of the following RF ablation generators: Maestro 3000™, Stockert™, or IBI™. Do not use the system with other RF ablation generators. Compatibility with other RF ablation generators has not been demonstrated.
• Do not apply RF energy larger than 150W to ablation catheters that are connected to the Maestro 3000 RF generator and the Rhythmia Mapping System.
• Do not apply RF energy larger than 70W to ablation catheters that are connected to the Stockert RF generator and the Rhythmia Mapping System.
• Do not apply RF energy larger than 50W to ablation catheters that are connected to the IBI RF generator and the Rhythmia Mapping System.
• To reduce the risk of electric shock or equipment damage, do not clean the Rhythmia Mapping System when it is plugged in, turned on, or connected to a patient. Cleaning the system while it is in use and connected to a power source may cause an electrical shock that could cause injury or death to the patient or user.
• To reduce the risk of electric shock, assure that any ECG cables and electrodes are not in contact with any other conductive parts, including ground.
• To reduce the risk of electric shock during defibrillation, assure that the exposed connector tips on the ECG output box are covered at all times with the protective, non-conductive material provided with the ECG output boxes. Do not use the ECG output box if the protective cover is damaged (see ECG Output Box).
• The system generates electrical impedance fields as part of its normal operation. Do not use other systems that also generate electrical impedance fields in the same procedure, as this may interfere with the system’s normal operation and reduce the quality of catheter localization, and signals.

Magnetic Localization System

• Do not operate the Localization Generator within 200 mm of installed cardiac implantable electronic devices (CIEDs). Doing so may affect pacing, temporarily suspend tachycardia therapy delivery, or lead to patient discomfort.

Signal Station

• To minimize the risk of electric shock, connect the Signal Station only to supply mains with a protective ground (earth) connection. Use only a functioning, properly tested supply main with protective ground (earth) to power the Rhythmia Mapping System. The use of a faulty, ungrounded supply main increases the risk of electrical shock and system malfunction.
• To minimize the risk of electric shock, prior to using the Rhythmia Mapping System, connect the equipotential socket (located on the Signal Station rear panel) to a common ground. This connection grounds the Rhythmia Mapping System and must remain connected at all times (see Signal Station Setup in the DFU).
• The Signal Station requires a dedicated, 24V DC power supply, which is provided by Boston Scientific with the Signal Station. To reduce the risk of Signal Station damage, use only the power supply provided by Boston Scientific for use with the Signal Station.
• To reduce the risk of Signal Station damage, do not connect or disconnect the Signal Station to its power supply while the Signal Station is turned on.
• To minimize potential exposure to water or liquid, prevent fluids from entering air vents. Do not place beverages or containers of water or liquid directly on or near the Signal Station or other system components.
• Do not block the air vent on the Signal Station during Signal Station use. Blocking the air vent during Signal Station use can cause the Signal Station to overheat, which may affect system operation.
• Use only a flat stable surface to hold the Signal Station and Signal Station-related accessories.

Workstation

• To minimize potential exposure to water or liquid, do not place beverages or containers of water or liquid directly on or near the Workstation or other system components.
• Use only a flat stable surface to hold or transport the Workstation and Workstation-related accessories.
• To prevent loss of data, frequently back up the data by archiving cases no longer needed for immediate access.

Cables

• Use only the ECG cables supplied by Rhythmia™ Medical for use with the Rhythmia Mapping System. ECG cables provided by Rhythmia Medical are designed and tested to protect the Signal Station from defibrillation energy. Using other ECG cables may cause serious damage to the system hardware.
• Prior to using the Rhythmia Mapping System, inspect all external connections and cable connectors. Make sure all connections are secure. Tighten any loose connections prior to using the system.
• Do not use excessive force when connecting or disconnecting cable connectors. Excessive force can damage the connectors, which may cause system malfunction.
• Do not kink or sharply bend cables. Kinks and sharp bends can damage the cables, which may cause system malfunction.
• To minimize the risk of damage, store unused system cables in a clean, dry, and secure location, consistent with storage guidelines (see Equipment Storage & Transporting in the DFU).

Electrical

• Never use ungrounded electrical outlets to power any system components. Do not use extension cords or adapters for ungrounded outlets. Using ungrounded outlets, extension cords, or adapters may cause equipment damage, system failure or malfunction.

Body Surface Electrodes

• Use care when attaching the body surface electrodes to lead connectors. To minimize the risk of electric shock, make sure that electrodes and lead connectors do not contact one another or contact ground.
• To prevent low quality signals from body surface electrodes, properly prepare the skin prior to attaching the electrodes. Do not use excessive gel as this may lead to shorts between different electrodes.

Environmental

• Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may damage connectors, which may cause system malfunction.

Magnetic Localization System

• Manually disabling the Localization Generator disables all catheter visualization and localization capabilities, including impedance tracking.
• Do not place the Localization Unit (SCU) or Sensor Interface Unit (SIU) within 1m of the Localization Generator. Doing so may lead to inaccurate tracking.
• Do not place cables used with the Rhythmia Mapping System within 30mm of the Localization Generator cable. If these cables are within 30mm or less, particularly if they are parallel to each other, inaccurate tracking or “noisy” signals may occur.
• Do not coil the Localization Generator cable. Doing so can disturb the magnetic field of the Localization Generator, which may lead to inaccurate tracking.
• Do not use the Magnetic Localization System in the presence of other magnetic fields or large metal objects. Doing so may lead to inaccurate tracking.

Localization Generator

• Manually disabling the Localization Generator disables all catheter visualization and localization capabilities, including impedance tracking.

During the Procedure

• To reduce catheter configuration mistakes, when connecting catheters to the system, always verify the signals by reviewing the signal display and recording system to ensure correct configuration of catheter electrodes to displayed channels.
• To ensure correct clinical decisions, use fluoroscopy, ultrasound, pace mapping or other visualization techniques to verify mapping results and catheter position. Always compare the anatomical map to the patient’s expected anatomy.
• When a catheter localization error is encountered, use fluoroscopy or other visualization techniques to verify catheter location.
• Imported geometrical shells should only be used as a reference, for example to identify anatomical features in advance of mapping. Use other visualization tools, such as fluoroscopy or echocardiography to verify catheter location.
• During the mapping procedure, do not disconnect the Localization Unit from the Signal Station and/or the Localization Generator from the Localization Unit. Ensure caps are installed on Localization Unit SIU connection ports that are not in use.

91078317(REV AA)

INTENDED USE

The RHYTHMIA HDx™ Mapping System (the system) is a 3D mapping and navigation system used in EP procedures. The SiS and related accessories provide data connection pathways for external input/output devices (e.g. catheters and recording systems) and serve as the data conduit to the system workstation and software.

INDICATIONS FOR USE

The RHYTHMIA HDx Mapping System and accessories are indicated for catheter-based atrial and ventricular mapping. The mapping system allows real-time visualization of intracardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intracardiac electrograms, may also be recorded and displayed on the system’s display screen.

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS

• Diagnosis and treatment of cardiac arrhythmias using the system in conjunction with radio frequency (RF) ablation and other medical devices may pose a risk of adverse events. Adverse events (e.g. cardiac perforation, new arrhythmias, exacerbation of existing arrhythmias) may require additional intervention.
• Do not use the system to route life-sustaining pacing signals. Only diagnostic stimulation signals (e.g. induction) may be routed through the system.
• All devices that are connected to system hardware must independently meet IEC 60601-1 requirements as well as any other relevant safety standards. The combined hardware configuration must also meet IEC 60601-1 safety standards. The use of system hardware with accessories and devices that do not comply with relevant standards may reduce the safety of the system, cause equipment damage or system malfunction, or harm to the patient or user.
• System hardware must be connected solely to a functional, properly-tested supply main with protective ground (earth). Do not use extension cords or adapters for ungrounded outlets. The use of a faulty or ungrounded supply main increases the risk of electrical shock and system malfunction.
• Do not connect more than one ablation catheter simultaneously to the Ablation System when used with Rhythmia HDx Mapping System.
• The system generates electrical impedance fields as part of its normal operation. Do not use other systems that also generate electrical impedance fields in the same procedure, as this may interfere with the system’s normal operation and reduce the quality of catheter localization, and signals.
• Do not operate the localization generator within 200 mm of an implanted CIED (cardiac implantable electronic device.) Doing so may affect CIED pacing, temporarily suspend tachycardia therapy delivery, or lead to patient discomfort.

CAUTIONS

• Use care when attaching the body surface electrodes to lead connectors. To minimize the risk of electric shock, make sure that electrodes and lead connectors do not contact one another or contact ground.
• Properly prepare the skin prior to attaching the electrodes to prevent receiving low quality signals from body surface electrodes. Do not use excessive gel as this may lead to signal crossover between electrodes.
• To minimize signal interference, route the surface ECG cables across the torso instead of alongside it.
• To ensure correct clinical decisions, use fluoroscopy, ultrasound, pace mapping or other visualization techniques to verify mapping results and catheter position. Always compare the anatomical map to the patient’s expected anatomy. Incorrect catheter localization may lead to incorrect clinical conclusion or patient injury.
• The localization generator may interfere with implanted cardiac implantable electronic devices (CIEDs). When mapping a patient with such a device, consider interrogating the device pre – and post-procedure. This will identify any changes in programmed parameters which could then be corrected before transferring the patient from the procedure room. Consult the CIED manufacturer instructions for additional information.
• If it becomes necessary to interrogate or program an implanted CIED while using the system, temporarily turn off the localization generator by using the on-screen button located on the annotating and editing maps toolbar.

POTENTIAL ADVERSE EVENTS

Any potential clinical complications are in large part expected to be related to the accessory diagnostic and/or ablation catheters that are used with the system, rather than the system itself. In order to identify potential adverse events, the user is instructed to read pertinent directions for use documents associated with the catheters and ablation generators that will be employed during a mapping session. As with other mapping systems, the RHYTHMIA HDx™ Mapping System can be incidentally associated with minor or major clinical complications intrinsic to intracardiac procedures. Potential adverse events associated with the use of the system include, but are not limited to, the following:

Arrhythmias

Due to the programmed electrical stimulation performed during EP diagnostic procedures and catheter manipulations, patients undergoing EP procedures are at potential risk of arrhythmia. The patient may experience discomfort from the rapid pacing and/or the initiation of an arrhythmia. While the system has no active role in RF ablation, a risk does exist that the effectiveness of an RF ablation procedure could be suboptimal and cause the targeted arrhythmia to reoccur.

Misinterpretation of data

Poor catheter localization may lead to clinical data misinterpretation and the potential of resultant patient injury. To ensure correct clinical decisions, the physician must use fluoroscopy, ultrasound, pace mapping or other visualization techniques to verify 3-D mapping results and catheter position.

Electrical Hazards

With any electrical system there is a potential risk of electrical shock to the user, patient, and service representative.

92106607(Rev. E)