medtronic
990018 GENius RF Ablation Generator Operators Manual
Operators Manual
84 Pages
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990018 GENius™ Multi-Channel RF Ablation Generator
Operator’s Manual
990018 GENius™ Multi-Channel RF Ablation Generator Operator’s Manual
A guide for setting up and using the 990018 generator and its components.
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The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners. Ablation Frontiers, GENius, Multi-Array Ablation Catheter, MAAC, Multi-Array Septal Catheter, MASC, Medtronic, Pulmonary Vein Ablation Catheter, PVAC, Tip Versatile Ablation Catheter, T-VAC
Contents Explanation of symbols 1
7
Introduction to the generator Description and intended use Warnings
12
12
Precautions
17
Indications
18
Contraindications
2
11
18
Potential adverse events
18
Compatible components
19
Generator controls and connections System overview
22
Operating modes
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Front panel
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Remote control panel
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Rear panel 28 3
Display screens 31 Language selection instruction display
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Patient return electrode placement image 34 Setup Screen
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Standby Screen
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Ablation Screen
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Sample system message display 4
Preparing for ablation
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Inspecting the system components
42
Ensuring the catheter interface cable is sterile 42 Connecting non-sterile cables
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Connecting the remote control (optional) Initializing the generator
Applying patient return electrodes 5
45
Performing an ablation procedure Attaching the catheter
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44 47
48 GENius Generator Operator’s Manual
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Contents
Setting generator parameters Performing ablation
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Shutting down and disconnecting the system
50
Remove and dispose of the patient return electrodes 6 7
Troubleshooting
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System messages
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Generator maintenance, handling, and specifications Maintenance 64 Storage and handling Cleaning
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Technical specifications of the generator A GENius generator components 67 GENius Jr. Remote Control Remote control cable 70 ECG interface box
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ECG interface box cable ECG amplifier cable
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Catheter interface cable Power Cord
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Explanation of symbols
Explanation of symbols Explanation of symbols Refer to the package label and the product to see which symbols apply. The symbols that immediately follow appear on packaging. Serial number Reorder number Caution Warning (yellow) Lot number Keep dry Manufacturer Sterilized using ethylene oxide Do not use if package is damaged Use by Authorized representative in the European Community Package contents GENius Multi-Channel RF Ablation Generator
GENius Jr. Remote Control
ECG Interface Box
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Explanation of symbols Cable
Power cord Consult instructions for use Follow instructions for use (blue)
Product documentation Temperature limitations Humidity limitations
The symbols that follow appear on the generator or its components. Duration up
Duration down
Temperature up Temperature down Equipotentiality (chassis ground) Output power (non-ionizing electromagnetic radiation) Alternating current Caution: use only fuse rated at the indicated voltage, current, operating speed, and breaking capacity
GENius Generator Operator’s Manual
Explanation of symbols Defibrillation Proof Type CF applied part Patient return electrode Start button Stop button Standby button System meets the applicable Canadian and U.S. electrical safety standards. Conformité Européenne (European Conformity) This symbol means that the device fully complies with applicable European Union acts. Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. See http://recycling.medtronic.com for instructions on proper disposal of this product.
GENius Generator Operator’s Manual
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Introduction to the generator
1
Description and intended use Warnings
12
Precautions
17
Indications
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Contraindications 18 Potential adverse events
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Compatible components
19
12
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Chapter 1 Description and intended use
Description and intended use The Model 990018 Medtronic GENius Multi-Channel RF Ablation Generator (the generator) delivers temperature-controlled radiofrequency (RF) energy to user-selectable electrodes on compatible Medtronic multi-electrode cardiac ablation catheters. The generator automatically recognizes the attached cardiac ablation catheter and programs preset default temperature, ablation duration, and energy mode setting parameters. Ablation parameters, including ablation duration, energy mode, target temperature, and channels (electrode pairs), can also be manually selected. A display screen monitor is available for viewing real-time system and ablation parameters. The generator features the following RF energy mode selections: bipolar only, unipolar only, and combination ratios of bipolar:unipolar energy mode selections of 1:1, 2:1, and 4:1. An ECG interface box connects the catheter with the generator, patient return electrodes, the external monitoring equipment, and the pacing equipment that can be used during the procedure.
Warnings Note: For catheter-specific warnings, refer to the technical manual for the catheter being used. X-ray and fluoroscopic exposure – Minimize x-ray and fluoroscopic exposure. Due to the x-ray beam intensity and the duration of the fluoroscopic imaging during ablation procedures, patients and laboratory staff may be subjected to acute radiation injury and increased risk for somatic and genetic effects. Take all appropriate measures to minimize x-ray exposure to both patients and clinical staff. The long-term effects of protracted fluoroscopy have not been established.
GENius Generator Operator’s Manual
Introduction to the generator Warnings High electrode temperatures – Only use catheters as recommended, maintain catheter contact with cardiac tissue during ablation, and monitor the displayed electrode temperatures and power delivery, in order to avoid high instantaneous electrode temperatures. Temperatures above 80 °C during ablation may increase the patient’s risk of thromboembolic events (formation of coagulum), steam pops, and cardiac perforation, depending on the catheter type used. ■
Only use the catheter in the recommended anatomical location.
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Maintain catheter contact with cardiac tissue by holding the catheter during the ablation.
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Do not reposition, rotate, slide, drag or otherwise intentionally disengage and then re-engage the catheter electrodes with cardiac tissue while ablating. Stop ablation prior to performing any of these actions.
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During ablation, make sure that the electrodes are separated by at least as much distance as is present when the catheter is in the neutral position. Failure to maintain adequate separation may increase bipolar current between electrodes, resulting in high temperatures between electrodes.
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Monitor the displayed electrode temperature and power delivery during ablation. For Medtronic’s PVAC GOLD, MAAC, T-VAC, and MASC, deselect the affected electrode pair or discontinue ablation if the electrode does not reach 50 °C and is receiving maximum power delivery.
Use of RF energy near implanted devices – Implantable devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs), may be inhibited or otherwise affected by RF energy. Since RF ablation therapy may affect implantable devices: ■
Have temporary pacing and defibrillation equipment available.
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Program pacemaker sensing parameters to VOO or DOO to ensure that RF energy is not sensed as an intrinsic event.
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Program ICD detection parameters to OFF or MONITOR to ensure that the RF energy is not sensed and inappropriately treated as a ventricular fibrillation episode.
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Monitor surface and/or intracardiac electrograms and/or vital signs during RF energy delivery to assess for device interaction. Take appropriate action if any interaction is detected.
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Chapter 1 Warnings ■
Reprogram and confirm all parameters of implantable devices after an RF ablation procedure.
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Exercise extreme caution when delivering ablation energy in close proximity to implanted leads.
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Refer to the appropriate implantable device technical manual for additional information.
Electrical isolation during ablation – Do not allow the patient to contact grounded equipment that might produce electrical current leakage during ablation or DCCV (Direct Current Cardioversion). Patient should not contact earthed metal parts or parts with appreciable capacitance to earth. Electrical current leakage may induce arrhythmias that may result in the patient’s death. Placement of monitoring electrodes – Use monitoring systems that incorporate HF current-limiting devices. Do not use needle monitoring electrodes. Place all physiological monitoring electrodes as far away as possible from the patient return electrodes and their leads to avoid RF interference affecting the ability to interpret patient electrocardiograms (ECGs). Generator settings or equipment failure – Do not increase target temperature or ablation duration settings before checking for obvious defects or misapplication, as patient injury may occur. Apparent low power output or failure of the equipment to function correctly at normal settings may indicate faulty application of the patient return electrodes or failure of an electrical lead. Electromagnetic interference (EMI) radiated – The generator emits RF energy during ablation at a frequency level that may cause EMI with unshielded electronic equipment. To minimize EMI, the generator should be moved away from any other electronic device. If EMI is apparent during the application of RF energy, EMI may be reduced by repositioning the generator or other equipment. Electromagnetic interference (EMI) susceptibility – The generator has been designed to minimize electromagnetic interference (EMI). If interference should occur, move the generator away from the device generating the interference or place the generator at a different angle.
GENius Generator Operator’s Manual
Introduction to the generator Warnings Cable positioning – Position all cables associated with the generator so they do not come in contact with the patient or other leads. RF interference may affect the ability to interpret patient ECGs. Leakage current from connected devices – Use only isolated amplifiers, pacing equipment, and ECG equipment (IEC 60601-1 Type CF equipment, or equivalent), as patient injury or death may occur. Do not allow leakage current from any connected devices to the patient to exceed 10 microamperes (µA) under any circumstances. Equipment modification – Do not modify this equipment. Modifications may reduce system effectiveness and impact safety. Flammable materials – Do not allow flammable material in the area where RF ablation procedures are performed. The risk of igniting flammable gases, flammable agents used for cleaning or disinfecting, or other materials is inherent in the application of RF energy. Long-term risk – The long-term risks of lesions created by RF ablation have not been established. In particular, the long-term effects of lesions in proximity to the specialized conduction system or coronary vasculature are unknown. No direct skin contact during system testing – Do not test the operation of the ablation system through direct contact with the electrodes. Testing through direct skin contact may cause damage to healthy tissue. EP recording systems – Use only high-frequency, current-limiting EP recording systems or patient injury may occur. Equipment stability during use – Do not disturb or move the generator, ECG interface box, or cables while the catheter is positioned within the patient, as patient injury may occur.
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Chapter 1 Warnings System compatibility – Use only the following components with the Medtronic GENius Multi-Channel RF Ablation Generator: the supplied Medtronic ECG interface box and cable, GENius Jr. Remote Control and cable, compatible Medtronic multi-electrode cardiac ablation catheters, compatible Medtronic catheter interface cables, the supplied Medtronic ECG amplifier cable, and compatible patient return electrodes (two required; ValleyLab Models E7506 and E7507, ConMed Thermogard® Model 51-7810). Associated equipment and active accessories have a rated accessory voltage equal to or greater than the maximum output voltage. The safety and use of the system with other catheters or components have not been tested. Proper use of patient return electrodes – Use only the compatible patient return electrodes (two required; ValleyLab Models E7506 and E7507, ConMed Thermogard® Model 51-7810) when operating the ablation system. Prepare the area where the patient return electrodes are attached in accordance with the patient return electrode manufacturer documentation. For best contact, avoid areas with adipose tissue, bony prominences, fluid invasion, scar tissue, and excess hair (shave the patient if necessary). Do not use a patient return electrode that is beyond its expiration date, in damaged packaging, dry, or if it has been re-sterilized. Do not use electrode gel with the patient return electrodes. Do not attempt to reuse or sterilize the patient return electrode. Incorrect use of the patient return electrodes may reduce efficacy and patient safety during ablation. Grounded wall outlet – To avoid the risk of electric shock, this equipment must only be connected to supply mains with protective earth (grounded receptacle). Unintentional power output – Failure of the ablation equipment can result in an unintentional power output increase. An unintentional power output increase may impact patient safety. Stimulation equipment – Certain stimulation equipment may alter the RF energy waveform, which may trigger arrhythmias on rare occasions. To eliminate the influence of stimulation equipment during ablation, disconnect the stimulation equipment while ablating.
GENius Generator Operator’s Manual
Introduction to the generator Precautions Generator and power cord positioning – Position the generator and power cord so that the power cord can be easily accessed and disconnected. The power cord can be used to remove power from the generator and stop unintentional power output; this is not recommended during a normal procedure.
Precautions Related product literature – Do not attempt to operate this Medtronic cardiac ablation system prior to completely reading and understanding the GENius Multi-Channel RF Generator operator’s manual and the technical manual of the compatible Medtronic cardiac ablation catheter. Required use environment – Cardiac ablation procedures should be performed only in a fully equipped electrophysiology laboratory. Qualified users – This equipment should be used only by or under the supervision of physicians trained in left atrial ablation procedures using this Medtronic multi-channel RF ablation generator and compatible catheters. Regular inspection – Regularly inspect reusable cables for visual evidence of damage. Disposal of system components – Contact Medtronic for the return of non-disposable components. The following components are considered non-disposable: generator, ECG interface box, remote control, and cables. Generator placement – Place the generator on a level surface. Do not place other equipment on top of the generator. Do not place the generator on top of other equipment. Overheating the generator – Do not place the generator near heat-generating equipment. Do not block cooling inlets or outlets on the generator. Fluid incursion – The generator may not function correctly if the electronic circuitry or the connectors are wet: GENius Generator Operator’s Manual
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Chapter 1 Indications ■
Do not allow any fluid or moisture into the generator, the ECG interface box, or the cables.
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Do not hang fluids above the generator.
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Do not immerse the cables into fluids.
Unintentional patient burns – To avoid unintentional burns to the patient during RF energy delivery, do the following: ■
Minimize the distance between the dispersive electrode and the operating field.
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Minimize skin-to-skin contact between parts of the patient's body by covering these areas with dry gauze.
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Place monitoring electrodes as far as possible from surgical electrodes to minimize burns at the site of the monitoring electrodes.
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When using multiple ablation devices, remove those devices not actively in use from patient contact. In all cases, monitoring systems incorporating high frequency current-limiting devices are recommended.
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Ensure the entire area of each patient return electrode makes reliable contact with the patient’s body during ablation. Using the START button to initiate an ablation results in continuous activation of RF energy output for the programmed duration. Do not remove the patient return electrodes while the system is ablating.
Indications See the technical manual for the catheter being used.
Contraindications See the technical manual for the catheter being used.
Potential adverse events See the technical manual for the catheter being used.
GENius Generator Operator’s Manual
Introduction to the generator Compatible components
Compatible components The following components are used with the generator. For more details, see Appendix A GENius generator components on page 67. ■
ECG Interface Box, Model 990028
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ECG Interface Box Cable, Model 990020
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ECG Amplifier Cable, Model 990027
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Catheter Interface Cable, Model 990004 (supplied sterile)
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Two compatible patient return electrodes (ValleyLab Models E7506 and E7507, ConMed Thermogard® Model 51-7810) (required but not supplied)
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Compatible Medtronic multi-electrode cardiac ablation catheters (not supplied)
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GENius Jr. Remote Control, Model 990029 (optional)
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Remote Control Cable, 15 ft (4.57 m), Model 990041(optional)
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Remote Control Cable, 25 ft (7.62 m), Model 990042 (optional)
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Generator controls and connections System overview
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Operating modes
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Front panel
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Remote control panel 27 Rear panel
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Chapter 2 System overview
System overview Figure 2-1 shows connections among the generator, its components, the patient return electrodes, and a compatible catheter. 2
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10 13 9 11
1 GENius cardiac ablation generator
7 ECG amplifier cable
2 Monitor
8 ECG interface box cable
3 VGA monitor cables (not included)
9 Patient return electrodes (not included)
4 Equipotentiality (chassis ground) cable (not included)
10 Catheter interface cable
5 Power cord
12 (Optional) Remote control cable
6 ECG interface box
11 Catheter (not included) 13 (Optional) GENius Jr. remote control
Figure 2-1. The generator, its components, patient return electrodes, and catheter
GENius Generator Operator’s Manual
Generator controls and connections Operating modes
Operating modes The GENius Multi-Channel RF Ablation Generator incorporates three separate modes of operation: Setup, Standby, and Ablation.
Setup mode The Setup mode is used to set the following parameters prior to initiating an ablation: ■
Channels (system default is Off)
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Duration (system default is 60 seconds)
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Target temperature (system default is 60 °C)
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Energy mode (system default provided for each catheter) see “Energy mode power limits” on page 49
Standby mode The Standby mode displays electrode temperature information for all selected channels.
Ablation mode The Ablation mode starts the ablation sequence according to the front panel settings.
Front panel Figure 2-2 shows the front panel of the generator, where controls are available for operation. The panel also provides receptacles for the ECG interface box and the optional remote control.
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