Indications For Use/Contraindications
Caution: United States law restricts this device to sale by or on order of a physician.
Indications For Use:
The IBI-1500T9 Generator is intended for use with compatible St. Jude Medical temperature controlled ablation catheters for creating endocardial lesions to treat arrhythmias (i.e. superventricular tachycardias and atrial flutter).
• Therapy™: The generator is internally limited to 50 watts when used with 4mm Therapy™ catheters
• Therapy™ Dual 8™: The generator is limited to 100 watts when used with the Therapy™ Dual 8™ catheters.
• Therapy™ Cool Path™: The generator is internally limited to 50 watts when used with Therapy™ Cool Path™ catheters. A compatible external infusion pump must be connected when used with Therapy™ Cool Path™ catheters.
Contraindications:
The use of this device with a Therapy™ family ablation catheter is contraindicated:
• In patients with active systemic infection.
• If the patient has intracardiac mural thrombus or has had a ventriculotomy or atriotomy within the preceding four weeks.
Warnings, Precautions, Adverse Reactions
Warnings:
• Cardiac ablation procedures should be performed only by physicians thoroughly trained in the techniques of radiofrequency catheter ablation in a fully equipped electrophysiology laboratory.
• Catheter ablation procedures present the potential for significant x-ray exposure, which can result in acute radiation injury as well as an increased risk for somatic and genetic effects, to both patients and laboratory staff due to the x-ray beam intensity and duration of the fluoroscopic imaging. Catheter ablation should only be performed after adequate attention has been given to the potential radiation exposure associated with the procedure, and steps have been taken to minimize this exposure. Careful consideration must therefore be given for this use of the device in pregnant women. The long-term risk of protracted fluoroscopy has not been established. Therefore, careful consideration must be given for the use of the device in prepubescent children.
• Pacemakers and implantable cardioverter/defibrillators can adversely be affected by Radiofrequency (RF) signals. It is important to: a) have temporary external sources of pacing and defibrillation available during ablation, b) deactivate implantable cardioverter defibrillators (ICD’s) as they could discharge and injure the patient or be damaged by the ablation procedure, c) exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads, and d) perform complete pacing system analysis on all patients after ablation.
• RF Ablation within and in close proximity to the coronary arterial vasculature has been associated with myocardial infarction and death.
• When using an electrophysiology (EP) recording system, the equipment must be front-end isolated, or have an isolated patient cable.
• Failure of RF ablation generator could result in an unintended power output increase. In case of system malfunction, shut off RF power delivery by turning the rocker switch to the off position or disconnect the power cord.
Warnings Specific to the Therapy™ Cool Path™ Catheter:
• When the IBI-1500T9 generator is used with a Therapy™ Cool Path™ catheter, the temperature shown on the front panel temperature display is not the temperature of the tissue being ablated. It is the temperature of the irrigated tip electrode only.
• When the B. Braun Vista® basic pump is initialized, the ablation rate is 800ml/hr and the standby rate is 120ml/hr. If the pump rate is set by using the pump key pad (pump manual operation), the generator will not control the flow rates. To establish generator control, initialize the pump by following the set-up procedure.
• Do not perform ablation without sufficient irrigation when using the IBI-1500T9 with the Therapy™ Cool Path™ Catheter.
Precautions:
• Peri-procedural anticoagulation therapy is recommended for patients in persistent or chronic atrial flutter and those undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing right-sided procedures.
• The catheter impedance display on the cardiac ablation generator should be continuously monitored during RF power delivery. If a sudden increase in impedance is noted, power delivery should be discontinued. The catheter should be removed and inspected. Clean the distal tip of the catheter with a sterile gauze pad dampened with sterile saline to eliminate any coagulum.
• Do not immerse the cable connector in fluids; electrical performance could be affected.
• Adequate filtering must be used to allow continuous monitoring of the electrogram (EGM) during Radiofrequency power applications. Monitoring systems incorporating high frequency current-limiting devices are recommended.
• Desired ablation parameters must be set by the user; otherwise, the default values will be used.
• The long-term risk of lesions created by RF ablation has not been established. In particular, any long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown.
• Refer to the Operator Manual of the manufacturer’s Dispersive Indifferent Patch (DIP). Use of the 3M brand indifferent electrode is recommended with the IBI-1500T9 generator.
• Standard grounding procedures should be followed.
• The cardiac ablation generator is capable of delivering significant electrical energy. Patient or operator injury can result from improper handling of the catheter and DIP electrode, particularly when operating the device. During power delivery, the patient should not be allowed to come in contact with grounded metal surfaces. This can be achieved by placing a non-conductive material between the patient and the grounded metal surfaces. DIP electrode attachments are to be as close to operating field as possible.
• Position connecting cables such that contact with patient or other catheter, cables or connections is avoided.
• To minimize the possible hazard caused by the summation of leakage currents when several equipments are interconnected, this generator must be connected to the recommended power distribution system.
• Accessory equipment connected to the analog and digital interfaces must comply with the respective IEC standards (i.e. IEC 60950 for data processing equipment and IEC 60601-1 for medical equipment). Additional equipment connected to the signal input or signal output connections comprise a medical system and therefore, must comply with the requirements of IEC 60601-1-1.
• Apparent low power output, high impedance or failure of the equipment to function correctly at normal settings may indicate faulty application of the DIP electrode or failure of an electrical lead. Do not increase the power before checking for obvious defects or improper setup.
• The risk of igniting flammable gases or other materials is inherent in the application of RF power. Precautions must be taken to restrict flammable materials or oxidizing gasses from the surgical site and near the patient.
• Use non-flammable agents for cleaning and disinfection of the generator and accessories.
• This equipment has been tested and found to comply with the limits for medical devices as defined by IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation.
• This equipment generates, uses and can radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
1. Reorient or relocate the receiving device.
2. Increase the separation between the equipment.
3. Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.
4. Contact your Biomedical Engineer for help.
5. Consult the manufacturer for help.
• Ensure that reusable cables and accessories are inspected regularly and are functional.
• Output power selected is to be as low as possible for intended purpose.
• Do not connect items which are not specified as part of the system.
• Follow the system installation to achieve optimal use.
Precautions Specific to the Therapy™ 8mm catheters:
• Two Dispersive Pad electrodes must be used when power levels exceed 50 watts to minimize the potential of skin burns.
Precautions Specific to the Therapy™ Cool Path™ Catheter:
• When using the Therapy™ Cool Path™ Catheter, assess any pump alarms before continuing the procedure. If the B. Braun Vista® basic pump alarm sounds (when used with the Therapy™ Cool Path™ Catheter), irrigation and RF energy stop. Communication and flow must be evaluated. Remove and inspect the catheter for damage and the electrodes for coagulum. If necessary, clean the electrodes with a sterile saline and gauze pad. Ensure that the 6 irrigation ports are patent and that flow is continuous. Inspect irrigation tubing for obstructions, such as kinks and air bubbles. If during this inspection the flow through the catheter has been interrupted for any amount of time, repeat initial preparation of catheter and pump by purging the fluid in the catheter and irrigation tubing per standard technique.
• When using the Therapy™ Cool Path™ Catheter, inspect the IV tubing for air bubbles and sufficient continuous flow prior to its use in the procedure. Air bubbles may cause emboli. Non-continuous flow may lead to coagulation within and around the distal electrode resulting in blockage of irrigation ports.
• When a using B. Braun Vista® basic pump with the IBI-1500T9 generator, use the recommended interface cables and connectors.
• Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablating near structures such as the sino-atrial node, atrioventricular node, and arterial structures.
Potential Adverse Reactions:
Potential adverse events that maybe associated with catheterization and/or cardiac ablation include the following:
• Abnormal vision
• Adult Respiratory Distress Syndrome (ARDS)
• Air embolism
• Anaphylaxis
• Anemia
• Allergic reaction (anesthesia)
• Arrhythmias
• AV fistula
• Cardiac perforation/tamponade
• Cardiac thromboembolism
• Cerebrovascular accident (CVA)
• Chest pain/discomfort
• Complete heart block
• Component damage to ICD or implantable pacemaker
• Congestive heart failure/exacerbation
• Coronary artery spasm
• Death
• Dislodgement of implantable cardioverter defibrillator or permanent pacing leads
• Dizziness
• Endocarditis
• Esophageal injury (fistula)
• Exacerbation of pre-existing atrial fibrillation
• Expressive aphasia
• Heart Failure
• Hemothorax
• Hypoxia/shortness of breath
• Increased phosphokinase level
• Infections/sepsis
• Laceration
• Local hematomas/ecchymosis
• Myocardial infarction
• Neck/pain/groin pain
• Obstruction or perforation or damage to the vascular system
• Palpitations
• Pericardial effusion
• Pericarditis
• Phrenic nerve damage
• Pleural effusion
• Pneumonia
• Pneumothorax
• Pseudoaneurysm
• Pulmonary edema
• Pulmonary embolism
• Radiation injury
• Respiratory Depression
• Seizure
• Skin burns
• Syncope/near syncope
• Temporary complete heart block
• Thrombi
• Thromboembolism
• Transient ischemic attack (TIA)
• Unintended (in)complete AV, sinus node or other heart block or damage
• Valvular damage/insufficiency
• Vascular bleeding
• Vasovagal reactions
• Ventricular tachycardia
• Worsening chronic obstructive pulmonary disease
