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 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

• 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.
• Do not use the system to route life-sustaining pacing signals. Only diagnostic stimulation signals (e .g ., induction) may be routed through the system. Using the system to route life-sustaining pacing may result in prolonged bradycardia.
• 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. Using the system to route life-sustaining pacing may result in prolonged bradycardia.
• Do not condition an IntellaMap Orion mapping catheter when it is in contact with the patient, either external or indwelling. Conditioning when in contact with a patient may lead to patient injury, including new arrhythmias or exacerbation of existing arrhythmias.
• Avoid increasing power or duration of RF application beyond your standard of care to target a specific change in local impedance. Doing so may result in damage to adjacent structures, perforation caused by steam pop, arrhythmias, and/or embolism.
• Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.
• 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.
• 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.
• Confirm catheter proximity to sheath using tools such as fluoroscopy or intracardiac echo.
• Sheath detection is to be used with compatible Agilis™, Zurpaz™, and Direx™ sheaths. The performance of sheath detection with other sheaths has not been tested. Refer to the Instructions for Use for the catheter for information on compatible sheaths for that catheter family.

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 Instructions 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. F)