RF Generators

Atakr® II RF Ablation System

(60 Watt output)

(Atakr^® II) The Atakr II RF Generator provides high power output with the integral safety of closed-loop temperature control using the embedded thermocouples in Medtronic RF ablation catheters.

Features:

• 60 Watt output
• Closed-loop temperature control
• Operates in power or temperature mode
• LEM feature provides tip to tissue contact
• Adjustable impedance parameters
• Adjustable power and temperature limits for safety
• Remote control electronic foot pedal
• Line powered
  

The System comes equipped with the following:

1 – 60 Watt RF Generator
1 – Electronic foot pedal
1 – Atakr to RF catheter cable
1 – Dispersive electrode cable
1 – Atakr to EGM cable

Warning

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Atakr^® II RF Ablation System

Indications for use
The Atakr II ablation system is indicated for use for the following:

• Interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia
• Treatment of AV nodal re-entrant tachycardia
• Creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia

Contraindications
The Atakr II ablation system is contraindicated for the following:

• Patients with active systemic infection
• The transeptal approach in patients with left atrial thrombus or myxoma or interatrial baffle or patch
• The retrograde transaortic approach in patients with aortic valve replacement

Warnings and precautions
System compatibility – Only use Medtronic RF catheters and accessories. The safety of use with other electrophysiology catheters or accessories has not been assessed.

Long term risks – The long-term effects of lesions created by
RF ablation have not been established.

• Any long-term effects of lesions in proximity to the conduction system or coronary vasculature are unknown.
• The risk/benefit in asymptomatic patients has not been studied.

AV node modification or septal accessory pathway ablation –
Immediately terminate RF energy delivery if partial or complete AV block is noted. Patients undergoing AV node modification or septal accessory pathway ablation are at risk for complete AV block. Closely monitor AV conduction during RF energy delivery.

Left-sided ablation – Patients undergoing left-sided ablation procedures should be closely monitored during the post-ablation period for clinical manifestations of infarction, thromboembolus or stroke.

Left-sided catheter insertions – Anticoagulate patients undergoing left-sided catheter insertions.

High ablation temperature – High ablation electrode temperatures, often caused by coagulum formation on the ablation electrode, may lead to charring of the cardiac tissue, or a vaporization of interstitial and intracellular fluid. To reduce the possibility of hazards associated with high temperatures:

• Use an RF catheter that features a thermocouple and adjust the temperature setpoint/limit to the maximum acceptable measured temperature (± 5C) for the ablation electrode. See “Setting the control mode, parameters, and options” in the manual for further information on adjusting the temperature setpoint/limit.
• Remove the RF catheter and examine the ablation electrode for
  coagulum. Remove any coagulum found.

Handling RF catheters –

• Use fluoroscopy during catheter manipulation and placement. RF power application within a coronary artery has been associated with myocardial infarction and death.
• Do not touch the ablation electrode of the RF catheter and the dispersive electrode at the same time while operating the RF power generator. Operator injury may occur.

Sudden impedance rise – Discontinue application of RF energy if a sudden impedance rise is observed. Remove the RF catheter and examine the ablation electrode for coagulum. Remove any coagulum found.

Non-thermocouple (NTC) RF catheters – NTC RF catheters do not provide temperature measurement. The RF power generator will operate only in power control mode when using NTC RF catheters:

• When using an NTC RF catheter, use an RF catheter interface cable designed for using NTC RF catheters with the Atakr II ablation system. Follow the directions provided in the RF catheter interface cable product literature when using the RF power generator with these NTC RF catheters.
• Do not use an RF interface cable designed for NTC RF catheters with an RF catheter that features a thermocouple.

X-ray and fluoroscopic exposure – Minimize x-ray exposure. Significant x-ray exposure can result in acute radiation injury as well as dose-related risk for somatic and genetic effects. Take all appropriate measures to minimize x-ray exposure to both patients and clinical staff.

Electrosurgery near flammable materials – The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Take precautions to restrict flammable materials and substances from the electrosurgical site. Flammable materials may come in the following forms:

• Anesthetics or skin preparation agents
• Natural chemicals produced within body cavities
• Chemicals originating in surgical drapes or other materials

Incidental patient burns – Avoid unintentional burns on the patient during RF energy delivery:

• Minimize the distance between the dispersive electrode and the operating field.
• Minimize skin-to-skin contact between parts of the patient's body by covering these areas with dry gauze.
• Place monitoring electrodes as far as possible from surgical electrodes to minimize burns at the site of the monitoring electrodes.

Using RF energy near implanted devices – Implanted devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), may be adversely affected by RF energy:

• Keep external sources of pacing and defibrillation available during ablation.
• Deactivate ICD detection during the delivery of RF energy.
• Exercise extreme caution when delivering ablation energy in close proximity to implanted leads.
• Perform complete implantable device testing before and after ablation.

DC energy – Do not deliver DC energy through the RF power generator. No testing has been performed on the RF power generator regarding the delivery of DC energy through it.

Fluid incursion – The RF power generator may not function correctly if the electronic circuitry or the connectors are wet:

• Do not allow any fluid or moisture into the RF power generator or any connector or cables.
• Do not hang fluids above the RF power generator.
• Do not immerse the cables into fluids.

Electrical shock – Do not touch the patient while touching the outer housing or connections on the Atakr II, to avoid the risk of electrical shock to the patient. Do not allow the patient to come into contact with grounded metal surfaces during RF energy delivery.

Line-powered equipment – An inserted RF catheter or an RF catheter connected to an RF catheter cable constitutes a direct, low-resistance current pathway to the myocardium. Due to the danger of tachyarrhythmias resulting from alternating current leakage, extreme caution must be taken to properly ground all line-powered equipment used on or in the vicinity of the patient.

Monitoring systems – Monitoring systems incorporating high-frequency, current-limiting devices are recommended. Monitoring electrodes should be placed as far as possible from surgical electrodes. Needle monitoring systems are not recommended.

Information technology equipment – All information technology equipment that is attached to the Atakr II ablation system must be approved by a third party to the requirements of UL 1950 or EN 60950.

Stimulation equipment – Certain stimulation equipment alters the RF energy waveform, which may lead to rare occasions of atrial or ventricular fibrillation. To eliminate the influence of stimulation equipment during ablation, use the options menu to disconnect the electrogram (EGM) device.

Electromagnetic interference (EMI) – This device is a non-ionizing emitter of radiation and may cause EMI with other devices. In order to minimize EMI, the generator should be at least 6 in. away from any other electronic device.

• If EMI is apparent during the application of RF energy, EMI may be reduced by repositioning the RF power generator or other equipment.
• If EMI occurs in electrogram or ECG recording equipment during RF energy delivery after re-adjusting the ablation electrode, use the options menu to disconnect the EGM device. If the EMI persists, unplug the ablation EGM electrode.

RF power generator failure – Failure of the Atakr II RF power generator could result in an unintended increase of output power. However, RF energy delivery stops if the operator selected or manufacturer programmed impedance, power, or temperature limits are exceeded.

RF power generator storage temperature – If the RF power generator has been stored at temperatures greater than 30°C or less than 15°C, allow the RF power generator to reach room temperature by waiting at least 30 minutes before use. The RF power generator may not function correctly if the electronic circuitry is too cold or too hot.

Adverse events
The potential adverse events related to the use of ablation systems include, but are not limited to, the following:

• Death
• Cardiac tamponade
• Cerebrovascular accident
• Myocardial infarction
• Coronary sinus perforation
• Bacterial endocarditis
• Ventricular fibrillation
• Coronary artery spasm
• Valvular insufficiency
• Femoral artery laceration
• Thrombus/embolic event
• Bowel obstruction
• Brachial plexus injury
• Pneumonia
• Inferior vena cava clot
• Deep vein thrombosis
• Pericardial effusion
• Pericarditis
• Pleural effusion
• Respiratory depression
• Atrial lead dislodgment
• Infected IV site
• Hypotension
• Bradycardia
• Vasovagal reaction
• Thrombophlebitis
• Temperature elevation
• Puncture site hematoma
• Phlebothrombosis
• High CPK
• Pulmonary embolism
• Thromboembolism
• Nerve or blood vessel injury
• Phrenic nerve injury
• Transient ischemic attack
• Infection
• Unintended AV or bundle branch block requiring
pacemaker implantation

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