OPAL HDx™ Mapping System

INTENDED USE
The OPAL 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 OPAL 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 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 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. The change in local impedance during RF delivery should not be used independent of established clinical indicators of RF tissue response (e.g. temperature limit, irrigation flow rate, power level, RF duration). Select ablation settings and limits (e.g. temperature limit, irrigation flow rate, power level, RF duration) in accordance with the compatible catheter Instructions for Use. Increases in contact force, ablation duration, or power in pursuit of a specific change in local impedance are not recommended.
• 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 OPAL HDx Mapping System. Doing so may lead to harm to the patient
• 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.
• The OPAL HDx Mapping System (the system) is intended for use with other medical devices in an EP laboratory. Carefully read the instructions for use (IFU) documents for every medical device that will be used during a study, prior to each study. Observe all contraindications, warnings, and cautions. Failure to do so may result in user harm, patient illness, injury, or death.
• Carefully read this entire document and all other product IFUs before beginning the mapping study. Be sure to fully understand and consistently follow all warnings, cautions, and instructions. Failure to properly follow the instructions may cause equipment damage, system malfunction, or harm to the patient or user.
• Always use the controls on the external stimulator to start or stop stimulation. The system only routes externally generated-and-controlled stimulation signals to the selected electrode and channel.
• During EP procedures, do not use the OPAL HDx Mapping System as an ECG monitoring device. To prevent delays in treatment of life-threatening arrhythmias, the system must always be used in conjunction with an ECG recording/ monitoring device.
• Do not use the OPAL HDx Mapping System and its accessories in an oxygen rich environment or near flammable anesthetics.
• Carefully read respective RF ablation generator IFUs before beginning the mapping study. Do not exceed power limits set by the manufacturer.
• To reduce the risk of electric shock or equipment damage, do not clean system hardware 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 enclosed at all times by the non-conductive protective cover that is built onto the ECG output boxes. Do not use the ECG output box if the protective cover is damaged. Only IEC 60601 compliance-certified stimulators should be used with the OPAL HDx Mapping System.
• The OPAL HDx Mapping System is intended for use by healthcare professionals only. This system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measure such as re- orienting or relocating the OPAL HDx Mapping System or shielding the location.
• When a catheter localization error is encountered, use fluoroscopy or other visualization techniques to verify catheter location. Incorrect catheter localization may lead to incorrect clinical conclusion or patient injury.
• To ensure correct clinical decisions, Field Tags should be used in conjunction with conventional verification techniques (e.g. assessing electrograms, pacing maneuvers, fluoroscopy/ echocardiography etc.) for the diagnosis and treatment of cardiac arrhythmias. To prevent patient injuries such as perforation, heart block, and injury to adjacent structures, do not rely solely on the Field Tag visualization to make clinical decisions.

PRECAUTIONS
• 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 CIEDs (cardiac implantable electronic device). 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.
• RF Catheter Sheath detection is to be used with compatible Agilis™ 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.
• Carefully inspect all system components prior to using system hardware. Do not use any component that shows evidence of being damaged or defective.
• Do not drop system components or subject them to extreme shock. Dropping components or forcefully hitting them against hard objects may damage components and cause system malfunction. Contact Boston Scientific Support for device repair or replacement.
• To minimize the risk of dropping and damaging equipment, use care when inserting/ removing components. If needed, use two people to attach or remove devices such as the localization generator.
• Do not use the OPAL HDx system closer than 30 cm (12 inches) to any Wireless Power Transfer (WPT) and 5G cellular devices, otherwise electromagnetic interference from those devices could result in degradation of the performance of this equipment.
• Do not position the signal station (SiS) in a manner that would make it difficult to disconnect the power supply from the power mains. Disconnect the power cord if the SiS needs to be isolated from the power mains.
• Connect the equipotential port on the rear panel of the SiS to an equipotential receipt box prior to using system hardware to minimize the risk of electric shock. This connection should remain connected at all times.
• Use only the SiS power supply and power supply cable provided by Boston Scientific with the system. Using another power supply or power supply cable may damage the SiS.
• Do not connect or disconnect the SiS power supply while the unit is turned on. This will minimize the risk of equipment damage.

• Disconnect SiS from its power supply prior to cleaning in order to minimize the risk of electric shock.
• Do not place containers of water or other liquids directly on or near the SiS or other system components. This reduces the risk of electric shock and/or damage to the SiS.
• Do not block the air vent on the SiS during use. Blocking the air vent can cause the SiS to overheat, which may affect system operation.
• Do not use SiS stacked or adjacent to other devices or equipment.
• Always use two hands to carry the SiS.
• Only place the SiS and SiS-related accessories on flat, stable surfaces. This will minimize the risk of dropped or toppled equipment.
• Disconnect all patient inputs from the SiS prior to pulsed field ablation. If available, accessories which automatically disconnect patient inputs prior to pulsed field ablation may be utilized. Leaving patient inputs connected during pulsed field ablation delivery may damage the SiS.
• In the event that routing of the stimulation signal through the mapping system software fails, direct stimulation may be required. Connect the stimulator jumper cables to any single pair of the direct stimulation ports located above input ports M, A, B, or ABL. The direct stimulation ports above input ports M, A, and B connect an external stimulator to channels 61 and 62 of the connected breakout box. The direct stimulation ports above the ABL port connect to channels 1 and 2 of the ablation catheter.
• Use only ECG cables provided with the SiS by Boston Scientific. The ECG trunk is part of the SiS’s defibrillation protection.
• The localization generator may interfere with other systems that use magnetic-field based technology. Consult the supplier of these systems before using them in the presence of the magnetic localization system.
• Use only the equipment, supplies, and accessories supplied or recommended by Boston Scientific for use with the OPAL HDx Mapping System. The use of other equipment, supplies and accessories may cause equipment damage or system malfunction. • Do not connect or disconnect the localization generator from the SiS while the unit is turned on. This will minimize the risk of equipment damage.
• Manually disabling the localization generator disables all catheter visualization and localization capabilities, including impedance tracking.
• Do not immerse system components in water, cleaning solutions, or liquid. Prevent fluids from entering air vents. Ensure connectors stay dry. Failure to follow cleaning guidelines may cause equipment damage or system malfunction, and may also void any warranties or service agreements.
• To avoid equipment damage and malfunction, do not attempt to sterilize equipment that is provided non-sterile.
• To avoid equipment damage and malfunction, do not insert anything (e.g., cotton swabs or pins) into cable connectors or equipment ports or openings.
• Do not attempt to clean system components during system operation. Cleaning equipment during use increases the risk of electrical shock, system malfunction, and device drop.
• Use a frequent back-up routine to archive cases that are no longer needed for immediate access. This will reduce the risk of data loss.
• 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.
• 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 generator from the signal station.
• The software monitors location reference back patch (back patch) and ECG electrode connections during a study. If the color-coded patch quality indicators on the patient alignment (user interface) turn from green to red (indicating a poor quality connection), adjust or replace the problem patch(es).
• The ECG cables (one trunk cable, chest leads set, and limb leads set) are provided nonsterile. They can be reused with multiple patients. Always clean and disinfect the ECG cables consistent with facility protocol prior to reuse.
• Do not enter patient identifiable data into any open fields that are not dedicated to patient information, or as part of file names being imported into the OPAL HDx Mapping System.
• Please refer to the Instructions for Use for the compatible catheter prior to enabling the display of DIRECTSENSE technology during RF energy application.
• Sheath detection is enabled for FARAWAVE Catheters with compatible FARADRIVE Sheath. 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.
• DIRECTSENSE local impedance is not an indicator of contact force.
• The OPAL HDx Mapping System should only be connected to a secure network.
• Do not place containers of water or other liquids directly on or near the workstation or other system components. This reduces the risk of electric shock and/or damage to the workstation.
• Use only a flat, stable surface to hold or transport the workstation and workstation-related accessories. This will minimize the risk of dropped or toppled equipment.
• Use only the ECG cables supplied by Boston Scientific for use with the system. ECG cables provided by Boston Scientific are designed and tested to protect the SiS from defibrillation energy. Using other ECG cables may cause damage to the system hardware.
• Inspect all external connections and cables before using the SiS and secure any connections that are loose. Loose connections may impact the accuracy of mapping results.
• 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 bend cables. Kinks and sharp bends can damage the cables, which may cause system malfunction.
• Store unused system cables in a clean, dry, and secure location consistent with storage guidelines to minimize the risk of damage. For specific storage guidelines, see Section 19 in the IFU.
• Direct stimulation is not compatible with the FARAWAVE catheter. The FARAWAVE catheter does not utilize electrodes 61 & 62. If direct stimulation is required, another catheter should be used.
• Do not 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.
• Avoid exposing system hardware to excessive moisture, heat or cold. Using the system in environmental conditions that exceed recommendations may affect system operation.
• When connecting or disconnecting system cables, protect the cable connectors from water or moisture. Wet connectors may affect system operation.
• Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may damage connectors, which may cause system malfunction.
• Always follow guidelines for equipment storage and transport. Storage or transport in extreme environmental conditions can damage system components.
• Do not place cables used with the system hardware within 30 mm of the localization generator cable. Inaccurate tracking or “noisy” signals may occur if these cables are within 30 mm distance between each other, particularly if they are parallel.
• 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 ferrous metal objects. Doing so may lead to inaccurate tracking
• Do not connect or disconnect the localization generator from the SiS while the unit is turned on. This will minimize the risk of equipment damage.
• The localization generator may interfere with fluoroscopy or other imaging modalities. Consult the supplier of these systems before using them in the presence of the magnetic localization system.
• Do not use the ECG cables or any other cables or system components if they are soiled or contaminated with infectious, or potentially infectious, materials. Using soiled or contaminated items increases the risk of patients acquiring serious infections or contaminating other patients or users. Soiled or contaminated cables and equipment must be removed from use and either cleaned according to established facility protocol procedures or replaced.
• Always clean multiple-use equipment according to established facility protocol prior to each reuse
• Do not use disinfectants such as glutaraldehyde or hydrogen peroxide to clean system components.
• Do not use solvents such as acetone to clean system components.
• Do not attempt to repair, modify, or open any part of system hardware. Repair attempts by untrained, unauthorized individuals may cause user injury, equipment damage, or system malfunction. Contact Boston Scientific Support for device repair or replacement.
• All external and accessible surfaces of this system should be cleaned and disinfected per the 51933747. Include any common detachable cables (power cord, video cables, accessories, etc.). Do not dispose of by incineration, burial or placement into common waste stream. System should be safely disposed of in accordance with hospital, administrative, and/or local government policy.

POTENTIAL ADVERSE EVENTS
Any potential clinical complications are in large part expected to be related to the accessory diagnostic 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 OPAL 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 Localization 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. Incorrect Force Measurements Incorrect force measurement displayed or misinterpretation of the force displayed may lead to the user to apply more force than desired during mapping or ablating. User must observe any system messages displayed. If the user applies more force than desired during mapping or ablating, myocardial perforation, myocardial contusion, or myocardial injury could result. Electrical Hazards With any electrical system there is a potential risk of electrical shock to the user, patient, and service representative.

97291991 (Rev. A.1)