INTELLAGEN™ Cardiac Ablation System

INTENDED USE/INDICATIONS FOR USE
The INTELLAGEN™ RF Generator is a specialized device intended for use during RF ablation therapy of the human heart. This device is used in conjunction with specialized therapeutic catheters and a dispersive pad (indifferent electrode) to create a closed electrical circuit capable of delivering specified doses of RF energy. The RF energy is delivered to cardiac tissue that forms unwanted electrical pathways that either drive or maintain arrhythmias. The RF energy heats the tissue such that it becomes denatured and no longer functional. This interrupts and/or destroys the unwanted electrical pathways, thereby restoring normal heart function.

Indications are defined for the respective applied part (ablation catheters).

CONTRAINDICATIONS
Contraindications are defined for the respective applied part (ablation catheters).
No contraindication known for the RF Ablation System.

WARNINGS
Warnings: Generator Usage
• Read this user manual carefully before using the INTELLAGEN™ RF Generator for the first time. Note especially the instructions in Section 4.5, Setup.
• Cardiac ablation procedures should be performed only by physicians who have been thoroughly trained in RF catheter ablation techniques. Catheter ablations should be performed only in medical rooms in compliance with IEC/EN 60601-1.
• In catheter ablation procedures, fluoroscopy is commonly used. When using fluoroscopy, there is the risk of exposure to considerable radiation. The intensity of the X-rays and the duration of the radiation can lead to acute radiation damage or to an increased risk of a physical or genetic defects for both patients and medical personnel. Therefore, perform catheter ablations only after carefully considering the potential radiation dose. The advantages and disadvantages of X-ray exposure should be considered carefully before catheter ablation is performed in pregnant women. Also, the long-term risk of prolonged X-ray imaging has not been researched. Therefore, the advantages and disadvantages should be considered carefully before this procedure is performed in prepubertal children. Consider using a navigation system without fluoroscopy to reduce exposure to X-rays.
• Do not apply RF energy while a stimulator is connected to the generator unless specifically indicated by the stimulator's instructions for use. Doing so might induce ventricular fibrillation.
• Always verify that the generator’s visual and acoustic alarms are working before using the generator (see Section 6.1.1, System Startup).
• When the generator has been turned off, power continues to be supplied to the generator through the mains cable. To completely cut off power to the generator, disconnect the mains cable from the generator. To allow easy disconnection in the event of severe power failure, make sure that the generator is located where there is easy access to the mains cable on the back of the generator.
• After turning on the generator, always wait until the automatic self-test has been successfully completed before starting the first steps of the procedure on the patient (for example, before anesthesia or before creating percutaneous access). Also, if using a remote control, a pump, a mapping system, or an electrophysiology recording system, verify that the connections to those systems are functional prior to starting the first steps of the procedure. Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient's health. Also perform a visual inspection of the accessories (see Section 5.3, Caring for Accessories).
• Use only catheters that have been approved for use with the maximum voltage specified in this user manual (see Section 8.1, Specifications).
• Use only accessories that have been provided by or recommended by the generator's manufacturer (see Chapter 5, Accessories). The use of other accessories can have a negative effect on the technical specifications. Do not modify accessories. Visually inspect all accessories on a regular basis. Make sure that the connected cables are not damaged. When using sterile accessories, be sure to maintain the sterility of those accessories.
• Place the generator on a secure, non-slip surface. If the generator is placed on a mounting plate, make sure it is securely fastened. Do not place the generator directly above another device and do not place any other device directly on the generator. Make sure that there is enough free space on all sides of the generator to allow the heat created by the generator to escape.

• The entire surface of the indifferent electrode must be as close as possible to the operating field and must have fully reliable contact with the patient's body. The skin surface must be free of excessive oil and body hair (see Section 3.3, Warnings and Precautions: During an Ablation Procedure.)
• The generator is equipped with a contact quality monitoring feature for split indifferent electrodes. If the contact quality falls below a defined value, the generator displays an alert message.
• The patient must not be in contact with grounded metal components or with metal components that have a large grounded area (for example, the operating table supports). For this purpose, the use of sufficiently insulating antistatic covers on the operating table is recommended. Electrostatic discharge (ESD) can give rise to extremely high current densities at the catheter tip, which can injure the patient. Therefore, do not touch the pins in the plug at the end of the catheter or the pins in the plug at the end of the cable after the catheter has been placed in the patient's body.
• Skin contact between parts of the patient's body (for example, between the arms and the body) should not occur. Such contact can be avoided by using dry gauze, for example.
• If the generator and physiological monitoring devices are used on a patient at the same time, all monitoring electrodes without protective resistances or RF filters should be applied to the patient’s body as far away as possible from the ablation electrodes. Needle electrodes are not recommended for monitoring purposes. In all cases, it is appropriate to use monitoring electrodes and other monitoring devices that limit the RF current.
• Position the connection cables of the ablation electrodes in such a way that they do not touch either the patient or other cables. Keep active electrodes that are temporarily not in use at a safe distance from the patient.
• Set the RF power at only moderate output to avoid charring and clotting at the catheter ablation electrode. Refer to the instructions for use of the connected catheter for recommended power settings.
• When the INTELLAGEN™ RF Generator is used with irrigated catheters, monitor the irrigation flow rate to avoid hazards caused by insufficient irrigation flow. The approximate flow rate can be estimated by observing the drip speed in the drip chamber. The hospital staff is responsible for determining and monitoring the flow rate to avoid insufficient flow of the irrigation solution. The hospital staff is responsible for monitoring the total amount of solution delivered to the patient to avoid an excessive loading of the irrigation solution in the patient. For recommended flow rates, refer to the catheter’s instructions for use.
• Avoid using flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen (O2) if the procedure is being performed in the region of the thorax or head, unless the gases are being aspirated off or an anesthesia-safe device is being used. Before starting RF ablation, allow time for flammable substances that are used as cleaning agents, disinfectants, or solvents to evaporate. There is a risk associated with flammable liquids under the patient or in the patient’s body cavities. Wipe away the liquid in these places away before the generator is turned on. Beware of flammable endogenous gases. Materials such as cotton and gauze, when saturated with oxygen, can be ignited by sparks that arise even during normal use of the generator. (The foot pedal is suitable for use in operating rooms.)
• Be aware during ablation procedures that in patients with intracardiac pacemaker, intracardiac defibrillator or relating leads, there is a risk of interference with the pacemaker or defibrillator that could lead to malfunction or damage of the same resulting in no therapy or inappropriate therapy. In case of doubt, consult the manufacturer of the implanted device.
• The electromagnetic radiation emitted by the generator can interfere with the function of other electrical devices. Conversely, other electrical devices can influence the function of the generator if they are operated at the same time in the immediate vicinity of the generator.
• The plugs on the catheter and the catheter connection cable must not be brought into contact with parts that have high voltage (such as mains outlets) or metallic objects. This can lead to the patient’s death by electrocution.

• To avoid damage to the connection cables, do not wrap the cables around the generator or other apparatus. Coiling the connection cables during normal operation of the generator creates inductive components, which can lead to measurement errors. The values indicated in error can lead to misinterpretations.
• Special safety measures with regard to electromagnetic compatibility (EMC) must be taken with electrical medical devices. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with this user manual, may cause harmful interference to radio communications. Similarly, portable and mobile communication devices may cause harmful interference to the functioning of the generator.
• If error messages repeatedly appear, stop using the generator and contact Customer Support.
• To avoid damage to the generator and its accessories, use only appropriate cleaning agents (see Sections 4.6, Preparing the Generator for Use/Reuse, and 5.4, Cleaning, Disinfecting, and Sterilizing Accessories).
• To avoid the risk of electric shock, connect the mains cable from the generator mains socket (see Item 6 in Section 4.3, Controls on the Back of the Generator) to a mains wall socket that meets the specifications in Section 8.1, Specifications. Do not connect electrical components of the generator to a multiple socket power strip. Using a multiple socket power strip may affect safety or performance.
• The generator may be opened only by persons authorized by the manufacturer. When the generator is open, parts that have high voltage or are very hot are accessible and can cause injury. If the generator is opened by an unauthorized person, any claims on the warranty are void. No modification of the generator is permitted.
• If fluid penetrates the generator, stop using the generator and contact Customer Support.
• In the unlikely event that there is a fatal system error (the system will stop and the Alarm indicator will flash red), immediately disconnect the mains cable from the generator.
• Electrodes and probes for monitoring and stimulation devices can be electrical conductors of RF current. Reduce the risk of burns by placing the electrodes and probes as far away as possible from the site of ablation and from the indifferent electrode.
• To avoid possible injury to patients and medical personnel, do not start RF power application until the catheter is positioned in the intended ablation area and the ablation parameters (temperature and impedance) are within the expected range.
• To minimize electrical noise on the ECG recordings, position catheter connection cables so that they do not touch either the patient or other cables. For an optimal ECG trace, keep unused active surface electrodes at a distance from the patient.
• To prevent fluid from impairing system performance, ensure that sterile catheters and cable plugs are completely dry.
• To prevent a system malfunction, inspect all reusable accessories regularly. Do not use damaged cables.
• Ablation data stored electronically must not be used for diagnosis or therapy. The intended use is for archiving or research only.

Warnings: System Safety and Connections
The INTELLAGEN™ RF Generator can be connected directly or indirectly to certain other devices and accessories. The generator and the connected group of devices and accessories are referred to in the following warnings as the “system.”

• The generator connections for the ECG signals and for the stimulator are galvanically connected with the ablation catheter. Only cables and plugs approved for a CF type of device (CF safety classification) may be used (see Section 5.2, Accessory Lists).
• All devices with these cables and plugs must fulfill the requirements stated in IEC/EN 60601-1-1. Fulfillment of the requirements must be monitored and documented in a suitable way.
• The person who connects the generator and accessories to each other or who uses the generator and accessories is responsible and liable for installation and operation that complies with IEC/EN 60601-1-1.
• All system components must comply with all applicable requirements and standards and be labeled pursuant to these standards.
• If there are any concerns regarding the use of a component, contact the distributor of the component to obtain further information.
• If several devices are connected to the generator and to each other, they should be as safe, both individually and together, as specified in IEC/EN 60601-1 and its sub-standards and IEC/EN 60601-1-2. All devices and accessories, when located within the patient area, must comply with IEC/EN 60601-1 and its sub-standards.

Keep in mind that the ECG connection cable for the generator creates a direct electrical connection to the patient's heart. Incorrect use of this connection can endanger the patient's life. Make sure that the leakage current of the connected system (in any combination) never exceeds the maximum permissible value (patient leakage current ≤ 0.05 mA).

Take into account that the system's RF leakage current can be negatively influenced by other system components. The maximum allowable values are specified in IEC/EN 60601-2-2. Displacements of the ECG baseline surface signals is a sign of uncontrolled RF current leakage through the body surface ECG electrodes. Heating of these electrodes gives rise to a shift in direct current voltage which, in turn, leads to a displacement of the baseline. In this case, check the whole system combination to avoid uncontrolled current leakage. It may also be the case, however, that the electrocardiograph is unsuitable for this use or that the body surface ECG electrodes have a too high contact impedance. Make sure that the ECG device is appropriate for this application. Skin burns at the body surface ECG electrodes can be a sign of uncontrolled current leakage.

• There are many electrocardiographs to which a stimulator can be directly connected. The stimulator must be galvanically isolated (or physically disconnected) before the RF current is turned on. The reason for this is the parallel connection between the output of the generator and the stimulator. If the connection is not isolated, the stimulator's patient interface and safety insulation may be damaged. The transfer of RF energy into the electrodes connected to the stimulator can also cause injury to the patient.
• Only classified electrical medical devices may be connected to the generator. If a PC system does not fulfill the requirements of IEC/EN 60601-1 / UL 60601-1 and their sub-standards, the distance between the PC system and the patient must be at least 1.83 m (6 ft) and the PC system must fulfill the requirements of IEC 950 / UL 60950-1. All medical devices that are connected electrically to the generator must fulfill the requirements of IEC/EN 60601-1-1, the standard for medical systems.
• When the RHYTHMIA HDx™ Mapping System is connected to the INTELLAGEN™ RF Generator, the impedance reading on the generator may be higher than expected. Consult the instructions for use provided with the RHYTHMIA HDx™ Mapping System for further information and restrictions.
• Do not use the INTELLAGEN™ ablation system with its accessories and catheters 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.

Warnings and Precautions: During an Ablation Procedure
• Blood vessel perforation is a risk inherent in the placement of an electrophysiology catheter. The catheter needs to be moved carefully to avoid damage or perforation of blood vessels.
• When performing ablation of the posterior wall of the left atrium, beware of the risk of forming a lesion in the esophagus.
• Avoid high ablation temperatures. High ablation temperatures can lead to clot formation, charring of the heart tissue or blood, and/or evaporation of interstitial intracellular fluid.

Note: The temperature indicated on the generator is not the tissue temperature. The indicated temperature is the temperature of the catheter’s ablation electrode, which does not necessarily represent the tissue temperature. This applies especially when catheters with saline-cooled ablation electrodes are used.

When catheters with cooled ablation electrodes are used, the temperature measurement reflects the temperature of the cooled electrode, not the temperature of the tissue. The temperature of the tissue may be distinctly higher and the risk of steam pops (explosion of steam bubbles) may increase. Therefore, use only moderate RF power output. Follow the recommendations in the instructions for use provided with the therapeutic catheters that are used with the system.

• Keep in mind when setting the temperature that only the temperature of the electrode and not the temperature of the heart tissue is measured. Because of the cooling effect of blood flow, the temperature of the heart tissue may be higher than the temperature measured at the ablation electrode.
• Avoid sudden increases in impedance to minimize charring at the ablation electrode. Charring at the ablation electrode can result in reduced RF energy delivery and/or an embolism.
• Make sure that the active RF electrode of the ablation catheter is not in contact with another catheter or with another metallic conductor, such as an implanted pacemaker lead. This could lead to uncontrolled conduction of the RF energy to other parts of the body, or to an uncontrolled increase in the effective size of the active RF electrode.
• Do not set any extreme, unrealistic limit values. The limit values serve to trigger an alarm when a limit value is exceeded. If unrealistic values are set, important alarm functions will be triggered too late or not at all.
• To minimize the risk to the patient, do not exceed the ablation duration specified in the instructions for use for the catheter.
• When using the usual operating settings, a low output RF power or a problem with the ablation device can be a sign that the indifferent electrode is not correctly positioned or has poor contact with its connection cable.
• Continuously monitor the generator's impedance measurement during RF energy application. If a sudden increase in impedance is observed, stop the RF energy delivery. Remove the catheter from the patient's body and clean the ablation electrode of the catheter with a sterile cloth to remove any adherent materials.
• If there is any doubt about an unintended increase in RF energy or the proper functioning of the touch screen, Data Entry Knob , foot pedal, or remote control during RF delivery, immediately stop the RF energy delivery by pressing the Stop button on the generator, releasing the foot pedal, or pressing the Stand-by button. If none of these measures stops the RF energy delivery, disconnect the mains cable from the generator.
• For patients with electrically conductive implants, a possible hazard exists due to concentration or re-direction of high-frequency (HF) currents. In case of doubt, qualified advice should be obtained.
• This device is not intended for use as an electrosurgical cutting device. The use of RF ablation devices at high temperature may lead generation of smoke plume. Care should be taken by the operator to reduce exposure to smoke plume by using smoke plume extraction.

Handling Indifferent Electrodes
An indifferent electrode is used for unipolar ablations (see Section 2.4, Unipolar Application Method).

When connected to the system, the generator monitors the impedance at the indifferent electrode, which is an indicator of the quality of adhesion of the electrode to the patient skin.

• To ensure patient protection, the generator prevents unipolar ablation in the absence of an indifferent electrode.
• If the indifferent electrode is not correctly connected to the generator, the generator immediately stops RF energy delivery and displays a message.
• The generator is equipped with a contact quality monitoring feature for split indifferent electrodes. When a split indifferent electrode is used, the generator displays an alert message as soon as skin contact with the electrode surface decreases by 40% from the best achieved contact quality. This value is reset every time the indifferent electrode is disconnected from the patient.

The generator provides the option of connecting two separate split indifferent electrodes. Contact quality monitoring described herein works independently for each connected split indifferent electrodes.
It is strongly recommended to use two separate split indifferent electrodes in ablations with high output (> 50 watts), for heavy patients with a low muscle mass and in the case of prolonged RF energy delivery (> 60 seconds). If two split indifferent electrodes are used, apply one electrode to the left side of the ablation site and the other electrode to the right side of the ablation site, both at approximately the same distance from the ablation site. The two indifferent electrodes must not overlap.

Guide to the Use of Indifferent Electrodes with the INTELLAGEN™ RF Generator
• Use only compatible indifferent electrodes. For a list of compatible indifferent electrodes for the INTELLAGEN™ RF Generator please contact Customer Support.
• Solid and non-split indifferent electrodes shall not be used due to IEC 60601-2-2.
• Read the instructions for use for the indifferent electrodes carefully and take special note of the warnings and precautions sections.
• For a single-use electrode: Make sure that the electrode contact surface is not dry. If it is dry, replace it with a new, unused electrode before continuing with the ablation procedure. Do not use any contact gel with single-use electrodes. Use the single-use electrode for only one procedure. If the indifferent electrode becomes loose or needs to be moved, use a new indifferent electrode. Repeated use of an already applied electrode can mean a loss of adhesiveness and thus reducing contact quality.
• For a reusable electrode: Make sure that the electrode contact surface is not dry. If it is dry, use a small, evenly distributed quantity of conductive gel.
• Carefully select the contact area: Choose a muscular area on the back of the patient that is as near the heart as possible and that has sufficient blood flow. Do not place the indifferent electrode near wounds.

• Carefully prepare the contact area: Prepare the contact area on the patient and on the indifferent electrode according to the instructions for use provided with the indifferent electrode. Place the indifferent electrode closer to the ablation site than any ECG electrode or other products that could represent an alternative lead. Shave and degrease the skin.
• Carefully apply the indifferent electrode to the contact area: Make sure that the whole surface of the indifferent electrode forms a closed contact with the patient's back. There should be no pockets of air between the skin and the indifferent electrode. Oil, hair, dirt, repeatedly used adhesive electrodes, and electrodes of low quality can impair contact quality and increase the risk of a skin burn.
• Heat produced by thermal blankets or other sources of heat adds to the heat arising under the indifferent electrode. This increases the risk of skin burns. Do not use such sources of heat in immediate proximity to the indifferent electrode.

An unsuitable indifferent electrode or an incorrectly applied indifferent electrode can lead to burns on the skin surface. Check the indifferent electrode and the connection cable before use. Do not use these if they are damaged or modified.

Icons regarding Indifferent Electrodes in the Navigation Bar (see 6.1.4 Screen Features)

PRECAUTIONS

Precautions are included within the warnings documented in the previous section.

POTENTIAL ADVERSE EVENTS

Reported adverse events or complications for cardiac RF ablation procedures include, but are not limited to the following:
• Skin burns
• Cardiac tamponade
• Peripheral vascular complications (hematomas, pseudoaneurysms, arteriovenous fistulas)
• Cerebrovascular events (stroke, transient ischemic attack)
• Pulmonary vein stenosis
• Phrenic nerve injury
• Atrio-esophageal fistula
• Death
For a full list of potential adverse events, please refer to the instructions for use of the respective applied part (ablation catheter).

97246162 Rev. A
 

INTENDED USE/INDICATIONS FOR USE

The INTELLAGEN™ RF Generator is a specialized device intended for use during RF ablation therapy of the human heart. This device is used in conjunction with specialized therapeutic catheters and a dispersive pad (indifferent electrode) to create a closed electrical circuit capable of delivering specified doses of RF energy. The RF energy is delivered to cardiac tissue that forms unwanted electrical pathways that either drive or maintain arrhythmias. The RF energy heats the tissue such that it becomes denatured and no longer functional. This interrupts and/or destroys the unwanted electrical pathways, thereby restoring normal heart function.

Indications are defined for the respective applied part (ablation catheters).

CONTRAINDICATIONS
Contraindications are defined for the respective applied part (ablation catheters).

No contraindication known for the RF Ablation System.

WARNINGS

Note: The warnings in this section cover the INTELLAGEN™ Remote Control specifically. See the INTELLAGEN™ RF Generator User Manual for additional warnings.

1. Read this user manual carefully before using the INTELLAGEN™ Remote Control for the first time. Note especially the instructions in Section 3.4, Setup.
2. Always verify that the remote control’s visual and acoustic alarms are working before using the remote control (see Section 5.1, Remote Control Startup).
3. When the remote control has been turned off, power continues to be supplied to the remote control through the mains cable. To completely cut off power to the remote control, disconnect the mains cable from the remote control. To allow easy disconnection in the event of severe power failure, make sure that the remote control is located where there is easy access to the mains cable on the back of the remote control.
4. After turning on the remote control, always wait until the automatic self-test has been successfully completed and the remote control has been made the Master of the system (see Section 5.3, Assigning the System Master) before starting the first steps of the procedure on the patient (for example, before anesthesia or before creating percutaneous access). Also, if using accessories that connect to the remote control, verify that the connections to those systems are functional prior to starting the first steps of the procedure. Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient's health.
5. Use only accessories that have been provided by or recommended by the remote control’s manufacturer (see Chapter 4, Accessories). The use of other accessories can have a negative effect on the technical specifications. Do not modify accessories. Visually inspect all accessories on a regular basis. Make sure that the connected cables are not damaged.
6. Make sure that the cable to the INTELLAGEN™ RF Generator is properly connected and that the remote control can be moved easily without disconnecting it from the generator (see Sections 3.4.1, Setting Up the and 3.4.3, Circular Plug Connections).
7. Place the remote control on a secure, non-slip surface as described in Section 3.4.1,Setting Up the Remote Control. Make sure that there is enough free space on all sides of the remote control to allow the heat created by the remote control to escape.
8. Other electrical devices can influence the function of the remote control if they are operated at the same time in the immediate vicinity of the remote control.
9. To avoid damage to the connection cables, do not wrap the cables around the remote control or other apparatus. Coiling the connection cables during normal operation of the remote control creates inductive components, which can lead to interruption of the operation of the remote control.
10. Special safety measures with regard to electromagnetic compatibility (EMC) must be taken with electrical medical devices. This equipment generates, uses, and can radiate radiofrequency energy and, if not installed and used in accordance with the user manual, may cause harmful interference to radio communications. Similarly, portable and mobile communication devices may cause harmful interference to the functioning of the remote control.
11. If error messages repeatedly appear, stop using the remote control and contact Customer Support.
12. To avoid damage to the remote control and its accessories, use only appropriate cleaning agents (see Sections 3.5, Preparing the Remote Control for Use/Reuse and 4.3, Caring for Accessories).

13. To avoid the risk of electric shock, connect the mains cable from the remote control mains socket (see Item 1 in Section 3.2, Controls on the Back of the Remote Control) to a mains wall socket that meets the specifications in Section 7.1, Specifications. Do not connect electrical components of the remote control to a multiple socket power strip. Using a multiple socket power strip may affect safety or performance.
14. The remote control may be opened only by persons authorized by the manufacturer. When the remote control is open, parts that have high voltage or are very hot are accessible and can cause injury. If the remote control is opened by an unauthorized person, any claims on the warranty are void. No modification of the remote control is permitted.
15. If fluid penetrates the remote control, stop using the remote control and contact Customer Support.
16. If there is any doubt about an unintended increase in RF energy or the proper functioning of the remote control’s touch screen, Data Entry Knob, or foot pedal, or the functioning of the generator during RF delivery, immediately stop the RF energy delivery by pressing the Stop button on the remote control or generator, releasing the foot pedal, or pressing the Stand-by button on the remote control or generator. If none of these measures stops the RF energy delivery, disconnect the mains cable from the remote control.
17. Take care when using the INTELLAGEN™ Remote Control and accessories. Although ablation cannot be started from the remote control when it is the system Monitor, ablation is automatically stopped when the Stop button is pressed or the foot pedal is released.
18. The person who connects the remote control and accessories to each other or who uses the remote control and accessories is responsible and liable for installation and operation that complies with IEC/EN 60601-1-1.
19. If several devices are connected to each other, they should be as safe, both individually and together, as specified in IEC/EN 60601-1 and its sub-standards and IEC/EN 60601-1-2.
20. Only classified electrical medical devices may be connected to the remote control. If a PC system does not fulfill the requirements of IEC/EN 60601-1 / UL 60601-1 and their sub-standards, the distance between the PC system and the patient must be at least 1.83 m (6 ft) and the PC system must fulfill the requirements of IEC 950 / UL 60950-1. All medical devices that are connected electrically to the generator must fulfill the requirements of IEC/EN 60601-1-1, the standard for medical systems.

PRECAUTIONS
Precautions are included within the warnings documented in the previous section.

POTENTIAL ADVERSE EVENTS
Reported adverse events or complications for cardiac RF ablation procedures include, but are not limited to the following:

• Skin burns
• Cardiac tamponade
• Peripheral vascular complications (hematomas, pseudoaneurysms, arteriovenous fistulas)
• Cerebrovascular events (stroke, transient ischemic attack)
• Pulmonary vein stenosis
• Phrenic nerve injury
• Atrio-esophageal fistula
• Death

For a full list of potential adverse events, please refer to the instructions for use of the respective applied part (ablation catheter).

97246163 Rev. A
 

INTENDED USE/INDICATIONS FOR USE

The INTELLAGEN™ Irrigation Pump is a peristaltic pump designed to work in conjunction with the INTELLAGEN™ RF Generator to deliver irrigation solution at specified flow rates to irrigated catheters for cooling purposes. The pump is used with the compatible Irrigation Tubing Set that conducts the irrigation solution from an external source to the compatible irrigated catheters.

Indications are defined for the respective applied part (ablation catheters).

CONTRAINDICATIONS

Contraindications are defined for the respective applied part (ablation catheters).

No contraindication known for the RF Ablation System.

WARNINGS

1. Before setting up the INTELLAGEN™ Irrigation Pump for the first time, carefully read this user manual. Pay special attention to the instructions in Chapter 3, Pump Setup. Also, read the user manuals for the compatible RF generator and the accessories and familiarize yourself with their use.
2. Always verify that the pump’s visual and acoustic alarms are working before using the pump (see Section 5.1, Turning the Pump on and Off).
3. When the pump has been turned off, power continues to be supplied to the pump through the mains cable. To completely cut off power to the pump, disconnect the mains cable from the pump. To allow easy disconnection in the event of severe power failure, make sure that the pump is located where there is easy access to the mains cable.
4. After turning on the pump, always wait until the automatic self-test has been successfully completed before starting the first steps of the procedure on the patient (for example, before anesthesia or before creating percutaneous access). Doing this helps to detect problems with the device before the patient is in a phase of the intervention in which interruption could lead to an increased risk to the patient's health.
5. Use only accessories that have been provided by or recommended by the pump’s manufacturer (see Chapter 4, Accessories). The use of other accessories can have a negative effect on the technical specifications. Do not modify accessories. Visually inspect all accessories on a regular basis. Make sure that the connected cables are not damaged. When using sterile accessories, be sure to maintain the sterility of those accessories.
6. Inspect the pump for damage before each use (see Section 7.5, Maintenance).
7. Special safety measures with regard to electromagnetic compatibility (EMC) must be taken with electrical medical devices. Portable and mobile communication devices may cause harmful interference to the functioning of the pump. Do not use portable or mobile communication devices in the vicinity of the INTELLAGEN™ Irrigation Pump.
8. Radio interference and electromagnetic fields can trigger false alarms and malfunctions in electrical units such as the INTELLAGEN™ Irrigation Pump. Furthermore, use of electrical units such as this pump can occasionally result in wrong values on ECG monitors that are not operated under optimal conditions. Although the pump is designed to avoid such interference, when the pump is used with electromagnetic navigation systems and ECG monitors, verify correct operation of the connected devices before use on a patient. If interference occurs, move the pump to another location.
9. If error messages repeatedly appear, stop using the pump and contact Customer Support.
10. To avoid damage to the pump and its accessories, use only appropriate cleaning agents (see Section 3.12, Cleaning and Disinfecting the Pump).
11. There are no parts in the INTELLAGEN™ Irrigation Pump that may be serviced by the user. (Exception: The fuses may be replaced per Section 3.6, Fuses.)
12. The pump enclosure may be opened only by persons authorized by the manufacturer. When the pump enclosure is open, parts that have high voltage or are very hot are accessible and can cause injury. If the pump enclosure is opened by an unauthorized person, any claims on the warranty are void. No modification of the pump is permitted.
13. The INTELLAGEN™ Irrigation Pump was calibrated by the manufacturer. Changing pump settings other than those described in Chapter 5, Pump Operation, will result in improper functioning and will void the warranty.
14. If fluid penetrates the pump, stop using the pump and contact Customer Support.
15. Use the INTELLAGEN™ Irrigation Pump only in combination with a compatible tubing set. If unsuitable tubing is used, the pump will not function properly, and improper irrigation will result.
16. A compatible sterile tubing set is intended for one-time patient use. To avoid biological contamination and ensure proper functioning, do not reuse or resterilize a sterile tubing set.
17. The INTELLAGEN™ Irrigation Pump monitors the flow of irrigation solution. If there is a problem with the solution flow, the pump stops the flow and issues an alarm. Correct alarm situations and restart the flow as quickly as possible.
18. The hospital staff is responsible for ensuring that the pump is functioning properly and that the solutions and irrigated catheters that are used in the overall irrigation process are compatible with each other. The INTELLAGEN™ Irrigation Pump and a compatible tubing set are intended for use with a standard irrigation solution such as a normal isotonic saline solution. The precision of the flow rate stated in the technical data may not be maintained if incompatible fluids and/or incompatible irrigated catheters are used.
19. The INTELLAGEN™ Irrigation Pump may be operated in the immediate vicinity of a compatible RF generator. However, do not operate the pump in the immediate vicinity of devices that are not approved for electromagnetic compatibility (EMC) with the pump. If such operation is unavoidable, regularly monitor the pump to ensure proper functioning.
20. Do not connect the INTELLAGEN™ Irrigation Pump to other infusion systems, including gravity intravenous (IV) infusion systems.
21. To prevent explosions, do not use the pump near explosive anesthetics.
22. To prevent electric shock and fires, do not expose the pump to excessive humidity.
23. To avoid the risk of electric shock, connect the pump to a mains wall socket that meets the specifications in Section 7.1, Specifications. Do not connect electrical components of the pump to a multiple socket power strip. Using a multiple socket power strip may affect safety or performance.
24. Parts such as the intravenous (IV) pole clamp, the rotating pump head, and the door that covers the pump head are designed for safe operation but must be used with caution.
25. The INTELLAGEN™ Irrigation Pump is intended for use with irrigated catheters. Monitor the irrigation flow rate to avoid hazards caused by insufficient irrigation flow. Monitoring the flow rate on the pump display alone is not sufficient because the flow rate is calculated from the pump motor speed. If the pump fails to rotate at the speed set by the user, the pump issues an alarm. However, because it is possible for a situation to arise during which the motor head is rotating but there is no flow, it is important to repeatedly monitor the approximate flow rate by observing the drip speed in the drip chamber. The drip chamber should be half to three-quarters filled to ensure no bubbles enter the tubing and provide visibility of the drip speed. The hospital staff is responsible for determining and monitoring the flow rate to avoid insufficient flow of the irrigation solution. The hospital staff is responsible for monitoring the total amount of solution delivered to the patient to avoid an excessive loading of the irrigation solution in the patient. For recommended flow rates, refer to the catheter’s instructions for use.
26. The person who connects the devices and accessories to each other or who uses the devices and accessories is responsible and liable for installation and operation that complies with IEC/EN 60601-1-1.
27. All system components must comply with all applicable requirements and standards and must be labeled pursuant to these standards.
28. If there are any concerns regarding the use of a component, contact the distributor of the component to obtain a further information.
29. The pump, the generator, and all accessories connected to the pump or generator, when located within the patient area, must comply with IEC/EN 60601-1 and its sub-standards.
30. If several devices are connected to each other, they should be as safe, both individually and together, as specified in IEC/EN 60601-1 and its sub-standards and IEC/EN 60601-1-2.
31. Do not put any labels or stickers on the front of the pump that will obscure the buttons or indicator lights.
32. The pump should be used only when the use of irrigation solution is appropriate relative to the medical condition of the patient. If it is not known what influence irrigation solution might have on a patient, consult with appropriate medical professionals before using this device.
33. When the pump is used alone for an ablation procedure, without being controlled by an RF generator, high flow of the irrigation solution should be started before the RF energy is turned on to allow the desired flow rate to be reached at the tip of the catheter. High flow should be continued for a few seconds after the RF energy is turned off to avoid thrombus formation on the ablation electrode.
34. Do not use the INTELLAGEN™ ablation system with its accessories and catheters 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.
35. Avoid using flammable anesthetics or oxidizing gases such as nitrous oxide (N2O) and oxygen (O2) if the procedure is being performed in the region of the thorax or head, unless the gases are being aspirated off or an anesthesia-safe device is being used. Before starting RF ablation, allow time for flammable substances that are used as cleaning agents, disinfectants, or solvents to evaporate. There is a risk associated with flammable liquids under the patient or in the patient’s body cavities. Wipe away the liquid in these places away before the generator is turned on. Beware of flammable endogenous gases. Materials such as cotton and gauze, when saturated with oxygen, can be ignited by sparks that arise even during normal use of the generator. (The foot pedal is suitable for use in operating rooms.)

PRECAUTIONS
Precautions are included within the warnings documented in the previous section.

POTENTIAL ADVERSE EVENTS
Reported adverse events or complications for cardiac RF ablation procedures include, but are not limited to the following:

• Skin burns
• Cardiac tamponade
• Peripheral vascular complications (hematomas, pseudoaneurysms, arteriovenous fistulas)
• Cerebrovascular events (stroke, transient ischemic attack)
• Pulmonary vein stenosis
• Phrenic nerve injury
• Atrio-esophageal fistula
• Death

For a full list of potential adverse events, please refer to the instructions for use of the respective applied part (ablation catheter).

97246165 Rev. A
 

INTENDED USE/INDICATIONS FOR USE

This Foot Pedal was developed to start and stop the corresponding function of the INTELLAGEN™ Cardiac Ablation System. The Foot Pedal is solely intended to be connected to the INTELLAGEN™ RF Generator, INTELLAGEN™ Irrigation Pump or INTELLAGEN™ Remote Control.

CONTRAINDICATIONS

No contraindication known for the Foot Pedal as part of the RF Ablation System.

WARNINGS

1. This product must not be present in the StereotaxisTM RMT lab. Using the Foot Pedal in RMT lab may inadvertently trigger the pedal to start delivering RF energy.
2. Do not use the Foot Pedal if it is mechanically damaged.
3. Do not transport the Foot Pedal by holding it by the cable.
4. Do not wrap the cable tightly around the Foot Pedal.
5. The person putting the Foot Pedal into operation is responsible for compliance of the whole system according to IEC/EN 60601-1.
6. The Foot Pedal must not be sterilized and is not suitable for automated cleaning and disinfection.

PRECAUTIONS

Precautions are included within the warnings documented in the previous section.

POTENTIAL ADVERSE EVENTS

No potential adverse events known for the Foot Pedal as part of the RF Ablation System.

97246166 Rev. A
 

INTENDED USE/INDICATIONS FOR USE

The tubing is intended to be used together with the INTELLAGENTM Irrigation Pump to deliver irrigation solution to irrigated catheters.

The tubing is indicated for use with irrigated catheters (together with the INTELLAGENTM Irrigation Pump).
Note: Further indications are defined for the compatible catheter.

CONTRAINDICATIONS

No contraindications are known for the tubing as a stand-alone product.

WARNINGS

• Use the tubing only with the INTELLAGENTM Irrigation Pump (see section “Compatibility” in this document for more information). Refer to the pump user manual for additional warnings, precautions, and product usage.
• Refer to the instructions for use provided with the specific catheter used, for additional warnings, precautions, usage, and
• recommended parameters.
• Use the tubing prior to the “Use-by” date printed on the package label.
• Inspect the sterile packaging before opening. Do not use the tubing if the packaging is opened or damaged.
• Inspect the tubing prior to use and do not use if damaged. Do not modify the tubing.
• Do not reuse, resterilize or reprocess the tubing due to the risk of contamination with microbiological organisms or a negative impact on the performance characteristics.
• The tubing can be damaged if inserted incorrectly. Follow these instructions for use as well as the pump user manual carefully.
• The tubing is intended for use with a standard irrigation solution, such as an isotonic saline solution.
• Make sure to repeatedly monitor the approximate flow rate by observing the drip speed in the drip chamber. This mitigates against a possible situation where the motor head is rotating but there is no flow.
• Do not use the tubing for longer than eight (8) hours, as it may compromise its performance characteristics (e.g. flow rate). Replace it after 8 hours before continuing with the procedure.
• With each new procedure, always use a new sterile tubing obtained from its original packaging.

PRECAUTIONS

Precautions are included within the warnings documented in the previous section.

POTENTIAL ADVERSE EVENTS

No contraindications are known for the tubing as a stand-alone product.

Potential Adverse Events are defined for the respective applied part (INTELLAGEN Irrigation Pump)

97246171 Rev. A
 

INTENDED USE/INDICATIONS FOR USE

The RHYTHMIA HDx Ablation Connection Box is intended for use with a compatible cardiac ablation system and associated catheters during mapping and ablation procedures.

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS

The RHYTHMIA HDx Ablation Connection Box is intended for use with other medical devices in an Electrophysiology (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. 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.

• Use only INTELLAGEN RF Generators with the RHYTHMIA HDx Ablation Connection Box. Do not use with other RF generators. Compatibility with other RF generators has not been demonstrated.

• Carefully read respective generator IFUs before beginning the mapping study. Do not exceed power limits set by the manufacturer, as this may increase the risk of patient injury.

• Carefully read the RHYTHMIA HDx Mapping System IFU before beginning the mapping study.

PRECAUTIONS

General
• Carefully inspect the device prior to each use. Do not use any component that shows evidence of being damaged or defective.
• Do not drop the device or subject it to extreme shock. Dropping the device or forcefully hitting it against hard objects may damage components and cause device malfunction. Contact Boston Scientific Support for device repair or replacement.

Cables
• Do not use excessive force when connecting or disconnecting cable connectors. Excessive force can damage the connectors, which may cause device malfunction.
• Do not kink or bend cables. Kinks and sharp bends can damage the cables, which may cause device malfunction.

Environmental
• Avoid exposing the device to excessive moisture, heat or cold. Using the device in environmental conditions that exceed recommendations may affect operation. For specific environmental guidelines, see How Supplied section.
• When connecting or disconnecting device cables, protect the cable connectors from water or moisture. Wet connectors may affect device operation.
• Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may damage connectors, which may cause device malfunction.
• Always follow guidelines for equipment storage and transport. Storage or transport in extreme environmental conditions can damage device. For specific storage and handling guidelines, see How Supplied section.

Cleaning and Disinfecting
• Do not immerse device components in water, cleaning solutions, or liquid. Ensure connectors stay dry. Failure to follow cleaning guidelines may cause device damage or 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 use the device if it is 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 use. Do not use disinfectants such as glutaraldehyde or hydrogen peroxide to clean device. Do not use solvents such as acetone to clean device. Failure to follow cleaning guidelines may cause device damage or malfunction.

Repair or Replacement
• Use only the equipment, supplies, and accessories supplied or recommended by Boston Scientific. The use of other equipment, supplies, and accessories may cause equipment damage or malfunction.
• Do not attempt to repair, modify, or open any part of the device. Repair attempts by untrained, unauthorized individuals may cause user injury, equipment damage, or malfunction. Contact Boston Scientific Support for device repair or replacement.

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 RHYTHMIA HDx Mapping System rather than the system itself. In order to identify potential adverse events, the user is instructed to read pertinent IFU documents associated with the catheters and RF generators that will be employed during an EP procedure.
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 device, 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 RHYTHMIA HDx Mapping 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 3D 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.

97246172 Rev. A

INTENDED USE / INDICATIONS FOR USE

The RHYTHMIA HDx Ablation Connection Box is intended for use with a compatible cardiac ablation system and associated catheters during mapping and ablation procedures.

CONTRAINDICATIONS

There are no known contraindications.

WARNINGS
The RHYTHMIA HDx Ablation Connection Box is intended for use with other medical devices in an Electrophysiology (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. 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.
• Use only INTELLAGEN RF Generators with the RHYTHMIA HDx Ablation Connection Box. Do not use with other RF generators. Compatibility with other RF generators has not been demonstrated.
• Carefully read respective generator IFUs before beginning the mapping study. Do not exceed power limits set by the manufacturer, as this may increase the risk of patient injury.
• Carefully read the RHYTHMIA HDx Mapping System IFU before beginning the mapping study.

PRECAUTIONS

General
• Carefully inspect the device prior to each use. Do not use any component that shows evidence of being damaged or defective.
• Do not drop the device or subject it to extreme shock. Dropping the device or forcefully hitting it against hard objects may damage components and cause device malfunction. Contact Boston Scientific Support for device repair or replacement.

Cables
• Do not use excessive force when connecting or disconnecting cable connectors. Excessive force can damage the connectors, which may cause device malfunction.
• Do not kink or bend cables. Kinks and sharp bends can damage the cables, which may cause device malfunction.

Environmental
• Avoid exposing the device to excessive moisture, heat or cold. Using the device in environmental conditions that exceed recommendations may affect operation. For specific environmental guidelines, see How Supplied section.
• When connecting or disconnecting device cables, protect the cable connectors from water or moisture. Wet connectors may affect device operation.
• Do not immerse any cable connectors in water or liquid. Immersion in water or liquid may damage connectors, which may cause device malfunction.
• Always follow guidelines for equipment storage and transport. Storage or transport in extreme environmental conditions can damage device. For specific storage and handling guidelines, see How Supplied section.
Cleaning and Disinfecting
• Do not immerse device components in water, cleaning solutions, or liquid. Ensure connectors stay dry. Failure to follow cleaning guidelines may cause device damage or 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 use the device if it is 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 use. Do not use disinfectants such as glutaraldehyde or hydrogen peroxide to clean device. Do not use solvents such as acetone to clean device. Failure to follow cleaning guidelines may cause device damage or malfunction.

Repair or Replacement
• Use only the equipment, supplies, and accessories supplied or recommended by Boston Scientific. The use of other equipment, supplies, and accessories may cause equipment damage or malfunction.
• Do not attempt to repair, modify, or open any part of the device. Repair attempts by untrained, unauthorized individuals may cause user injury, equipment damage, or malfunction. Contact Boston Scientific Support for device repair or replacement.

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 RHYTHMIA HDx Mapping System rather than the system itself. In order to identify potential adverse events, the user is instructed to read pertinent IFU documents associated with the catheters and RF generators that will be employed during an EP procedure.
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 device, 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 RHYTHMIA HDx Mapping 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 3D 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 User Operator 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.

97246173 Rev. A