Need Help?
Contact Us

INTELLAMAP ORION™ Mapping Catheter

Indications, Safety and Warnings


Prescriptive Information

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

  

INTELLAMAP ORION™ Mapping Catheter

INTENDED USE/INDICATIONS FOR USE

The IntellaMap Orion High Resolution Mapping 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.
  • Patients with a hypercoagulable state or who cannot tolerate heparin anticoagulation therapy.
  • Patients with prosthetic or stenotic valves, in the chamber where the prosthetic or stenotic valve reside.
  • Patients with active systemic infection.
  • Pediatric patients.
  • Pregnant and/or nursing patients.
  • Patients with any other condition where catheter manipulation may not be safe.
  • The IntellaMap Orion Catheter should not be used for radio frequency (RF) ablation.
  • The IntellaMap Orion Catheter should not be used inside an MRI machine.

WARNINGS

  • Keep the connector dry; wet connector pins may affect performance. Do not allow the handle or cabling to be immersed in fluid.
  • Do not use the catheter to deliver ablation therapy.
  • Do not expose the catheter to alcohol or other cleaning solvents.
  • 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.
  • 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.
  • Do not use the catheter with equipment (such as stimulators or recording systems) that is not isolated.

PRECAUTIONS

  • To avoid cardiac damage, do not use excessive force when manipulating the catheter in vivo. Specifically, use caution when maneuvering while undeployed. Note that mapping and recording data do not require the use of force on the tissue.
  • Always undeploy the catheter prior to removal from the patient. Use visualization (such as fluoroscopy) to verify undeployment.
  • Always move the articulation control lever to its neutral position to straighten the catheter prior to removal from the patient.
  • Only use guiding sheaths with curves that allow passage of the catheter without using excessive force.
  • When used with a steerable guiding introducer sheath:
  • Ensure under fluoroscopy that the guiding introducer sheath distal end is straight or, if necessary, only minimally curved prior to advancing or retracting the catheter through the sheath.
  • Do not articulate the sheath while the catheter array is inside the articulating section.
  • Do not deploy or articulate the catheter while the distal end is inside a sheath.
  • Do not apply RF energy on an ablation catheter that is in direct contact with the electrodes on the IntellaMap Orion Catheter.
  • To prevent entanglement, use care when using the catheter in the proximity of other catheters.
  • When pacing, verify desired waveform is observed.
  • 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.

POTENTIAL ADVERSE EVENTS

Serious adverse events have been reported in the literature in relation to cardiac catheterization including: stroke, cardiac tamponade, perforation, myocardial infarction, pulmonary embolism, and death. Complications reported included also (in alphabetical order): air embolism, arrhythmia, AV fistula, hematomas, hemothorax, pneumothorax, pseudoaneurysm, thromboembolism, valvular damage, vascular bleeding, and vasovagal reactions.

(Rev AA)

  

RHYTHMIA Mapping System

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.

(REV AA)

  

RHYTHMIA HDx™ Mapping System

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 its accessories are indicated for catheter-based atrial and ventricular mapping. The system enables 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.
  • Use only Maestro™ or EP-Shuttle RF ablation generators with the system. Do not use the system with other RF ablation generators. Compatibility with other RF ablation generators has not been demonstrated.
  • 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. 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.

(Rev B)

Top