Technical Manual
90 Pages
Preview
Page 1
Cardioblate_FCV.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
CARDIOBLATE® 68000 SURGICAL ABLATION SYSTEM
Technical Manual
M948371A001 Rev. 1A
Medtronic Confidential CS0017
Cardioblate_FCV.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
M948371A001 Rev. 1A
Medtronic Confidential CS0017
Medtronic Confidential CS0017
cardioblate_SYM.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
Explanation of symbols European Conformity. This symbol means that the device fully complies with European Council Directive 93/42/EEC. Attention, See Instructions for Use Dangerous Voltage Reorder Number Serial Number Manufacturer Temperature Limitation Nonsterile Content Atmospheric Pressure Limitation Humidity Limitation Date of Manufacture Type CF Applied Part Neutral Electrode Isolated from Earth High Frequency Dispersive Electrode Pad Electrogram Monopolar Bipolar Danger: Risk of explosion if used in the presence of flammable anesthetics With Respect To Electric Shock Fire And Mechanical Hazards Only In Accordance With UL60601-1/CAN/CSA C22.2 No. 601.1
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
i
Medtronic Confidential CS0017
cardioblate_SYM.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
ETL Listing (US/CAN) This device meets the requirement of UL60601, CAN/CSA C22.2 No. 601-1M90 and IEC60601-2-2 Non-ionizing Radiation Fuse Marking: Replace Fuses as Marked 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. Bipolar Device Monopolar Device Overall RF Energy Delivery Time Transmural Remote Control Foot Switch Graph Mode Volume Level Impedance Wattage Ohms, Unit of Impedance Measurement RF Energy Delivery Button Active Ablation Time Universal Serial Bus (USB) Port Connector Error Message Explanation Watts, Unit of Energy Measurement Maximum Limit Minimum Limit
ii
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
Medtronic Confidential CS0017
cardioblate_SYM.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
OFF (AC Power) ON (AC Power) Warning or Error Message For US Audiences Only China RoHS Standard (SJ/T11364-2006) Electronic Information Products Pollution Control Symbol. The number represents the years the device can be used before it must be recycled (environmental protection use period). Authorized Representative in the European Community
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
iii
cardioblate_SYM.fm 7/21/11 1:15 pm 7 x 9 inches (178 mm x 229 mm)
iv
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
Medtronic Confidential CS0017
cardioblateTOC.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Table of Contents How to Use This Manual vii Changing the Language Option vii 1
Overview
1-1
System Description
1-2
Indications for Use
1-4
Contraindications
1-5
Warnings and Precautions Adverse Events 2
1-10
Generator Description Components
1-5
2-1
2-2
Displays, Connectors, and Controls Audible Tones
2-9
Specifications
2-9
Output Power Diagrams
2-3
2-12
Electromagnetic Emissions and Immunity Declaration (EN60601-1-2) 2-14 3
Applicable Standards
2-18
Generator Operation
3-1
Quick Reference Guide
3-2
Selecting and Attaching a Dispersive Electrode 3-3 Preparing and Powering Up the Generator
3-4
Connecting a Cardioblate® Ablation Device
3-6
Verifying Generator Recognition of Attached Devices Disconnecting the Cardioblate® Ablation Devices Setting the RF Energy Mode and Parameters Monopolar Mode Selection and Use Bipolar Mode Selection and Use Options
3-9
3-9
3-9
3-14
3-17
Powering Down the Generator 4
3-8
3-23
Safety Shutdown and Troubleshooting Safety Shutdown Conditions
4-2
Safety Shutdown Messages
4-3
4-1
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
v
cardioblateTOC.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Other Messages System Shutdown 5
4-7 4-7
Device Maintenance and Service 5-1 Replacing the Generator Fuse Cleaning the Generator
5-2
5-2
Periodic Technical and Safety Inspection Service 6
5-4
Warranty 6-1 Medtronic Warranty Information
A Index
vi
A-1
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
6-2
5-3
cardioblate_Intro_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
How to Use This Manual This guide presents information for users of the Model 68000 Cardioblate® Generator. It contains information about the following: ■
Overview This chapter is a brief overview of the Cardioblate® Generator and the accessories that compose the Cardioblate® Surgical Ablation System.
■
Generator Description This chapter identifies and describes the generator case, controls, connectors, touch-screen information fields, and touch-screen interactive fields.
■
Generator Operation This chapter provides instructions for preparing the patient, setting up the generator system, and treating the patient.
■
Safety Shutdown and Troubleshooting This chapter provides information on safety shutdown conditions and messages and trouble-shooting.
■
Device Maintenance and Service This chapter identifies how to replace the fuse and clean the generator and provides information on technical and safety inspections.
■
Warranty This chapter describes the device and accessories warranties.
Changing the Language Option This information is also provided in Chapter 3. Note: English is the default language for the Medtronic Cardioblate® 68000 Generator. To change the language option: 1. Access the Options Menu To access the Options Menu, press the Options button located in the lower-right side of the RF panel screen.
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
vii
cardioblate_Intro_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
2. Select the Advanced screen Select the Advanced option, which will bring up the Advanced Options screen.
3. Select the Language button Press the Language button located in the lower left-side of the Advanced Options screen. Select the desired language. The following languages are available for use: ■
English
■
German
viii Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
cardioblate_Intro_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
■
Spanish
■
French
■
Italian
■
Greek
Note: At any time, the backwards arrow button to return to a previous screen.
can be used
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
ix
cardioblate_Intro_EN.fm
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
x
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
Medtronic Confidential CS0017
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Overview
System Description
1
1
1-2
Indications for Use 1-4 Contraindications 1-5 Warnings and Precautions 1-5 Adverse Events
1-10
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
1-1
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Chapter 1 System Description
System Description The Medtronic® Cardioblate® Surgical Ablation System Model 68000 consists of a generator and included accessories. The surgical ablation system is designed to deliver radiofrequency (RF) energy to selected sites via a Cardioblate® surgical ablation device (hereafter referred to only as the ablation device). The generator is line-powered and is designed to be placed on a table. The high-impact plastic generator case has a convenient carrying handle and a display screen. An easy-to-use latch mechanism secures and releases the display screen. The display screen provides users with real-time treatment information in graphical and digital formats. Message fields on the display screen also provide critical information during the treatment procedure. The user interface includes a touch-screen that responds to gloved and ungloved touch. When the user touches a control-button icon on the screen, the system performs the function selected if no errors exist. The user interface also provides unique audible tones to automatically notify the user of the treatment status or alert condition. Key features include the following: Touch screen operation – The generator parameters can be easily set and adjusted using the touch screen panel. RF energy modes – The generator controls the amount of energy being delivered through the ablation device in one of the following energy modes:
1-2
M948371A001 Rev. 1A
■
In monopolar mode, the generator monitors and controls the amount of RF energy delivered to the tissue between the ablation device and the dispersive electrode at a preselected power setpoint throughout the ablation.
■
In bipolar and enhanced bipolar modes, the generator monitors tissue impedance and adjusts the amount of power delivered to the tissue between the active electrode jaws to create transmural lesions.
■
EGM throughput is available in monopolar mode only.
Cardioblate® 68000 Technical Manual
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Overview System Description Safety shutdowns – RF energy delivery stops if the operator-selected or manufacturer-programmed impedance, power, or temperature limits are exceeded. If a warning message appears, see Chapter 4, “Safety Shutdown and Troubleshooting,” for detailed information.
Package Contents The Cardioblate® Surgical Ablation System (Model 68000) package may contain the following items (Figure 1-1): ■
One Model 68000 generator
■
One Model 60883 remote control foot switch
■
One power cord: Model 4807
■
Product literature
1
3
2 Figure 1-1. 68000 Generator
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
1-3
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Chapter 1 Indications for Use 1. Model 68000 generator 2. Power cord 3. Remote control foot switch
Other Applicable Accessories The following accessories are applicable to the Cardioblate® Surgical Ablation System but are not included in the Model 68000 package: ■
Medtronic® Cardioblate® surgical ablation devices ■
Model 60813 - Cardioblate® Surgical Ablation Pen
■
Model 60814 - Cardioblate® Surgical Ablation XL Pen
■
Model 60831 - Cardioblate® Surgical Ablation BP2 Device
■
Model 60841 - Cardioblate® Surgical Ablation LP Device
■
Models 49260/49261 - Cardioblate® Gemini™ Surgical Ablation Devices
■
Medtronic released products labeled for use with the Cardioblate® 68000 Generator as an external device
Caution: Cardioblate® bipolar device, Model 60821, cannot be used with the Cardioblate® 68000 Generator. Caution: Only use Medtronic® ablation devices and Medtronic recommended accessories. The safety of use with other surgical ablation devices, catheters, or accessories has not been assessed. ■
Dispersive electrode with a conductive adhesive and a minimum surface area of 100 cm2 (must be compliant with IEC 60601-2-2).
■
Model 60889 - Medtronic® Cardioblate® Diagnostic Kit
Indications for Use The Cardioblate® Surgical Ablation System is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.
1-4
M948371A001 Rev. 1A
Cardioblate® 68000 Technical Manual
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Overview Contraindications
Contraindications The Cardioblate® Surgical Ablation System is contraindicated for patients with active endocarditis at the time of surgery.
Warnings and Precautions General Product literature – Do not attempt to operate the Cardioblate® Surgical Ablation System or connect the ablation device to the generator prior to completely reading and understanding the product literature for the Cardioblate® Surgical Ablation System and the ablation device. System compatibility – Only use Medtronic ablation devices and Medtronic-recommended accessories. The safety of use with other surgical ablation devices, catheters, or accessories has not been assessed. Single Use Devices – Medtronic ablation devices designed for use with this generator are intended for single-time use. The Cardioblate Generator has functionality to prevent the reuse of the surgical ablation devices. Accessories – Regularly inspect and test reusable cables and accessories. Do not use any cable or accessory that appears to be damaged, and take the following precautions: ■
Inspect for insulation damage, such as brittleness, cracking, thinning or bare spots.
■
Replace damaged accessories.
See Chapter 2, “Generator Description,” for detailed information regarding accessories. Electrical shock and/or burns – To avoid the risk of electrical shock and/or burns to the patient, do not touch the patient while touching the outer housing or connections on the Cardioblate® generator. Do not allow the patient to come into contact with grounded metal surfaces during RF energy delivery.
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
1-5
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Chapter 1 Warnings and Precautions Electrostatic Discharge (ESD) is the sudden transfer or discharge of static electricity from one object to another. Human bodies can create ESD charges of up to 25,000 volts. ■
Connector pins identified with the ESD warning symbol should not be touched. NO connections should be made to these connectors unless ESD precautionary procedures are followed. ESD applied to one of these connectors may cause the generator to display an error message and interrupt RF energy delivery until the message is acknowledged and/or removed.
■
Precautionary procedures include the following: – Prevent electrostatic charge build-up (eg, air conditioning, humidification, conductive floor coverings, and nonsynthetic clothing); – Discharge one’s body to the frame of the equipment or system, to earth, or a large metal object prior to making a contact; – Bond oneself by means of a wrist strap to the equipment or system, or to earth prior to making a contact.
Ablation Therapy Hazards Lesions – The long-term effects of lesions created by RF ablation have not been established; note the following: ■
Any long-term effects of lesions in proximity to the conduction system or coronary vasculature are unknown.
■
The risks/benefits in asymptomatic patients have not been studied.
Artrioventricular (AV) node modification or septal accessory pathway ablation – Patients undergoing AV node modification or septal accessory pathway ablation are at risk for complete AV blockage: ■
Closely monitor AV conduction after RF energy delivery
Using RF energy near implanted devices – RF energy may adversely affect implanted devices, such as pacemakers and implantable cardioverter-defibrillators (ICDs). To avoid this, do the following:
1-6
M948371A001 Rev. 1A
■
Keep external sources of pacing and defibrillation available during ablation.
■
Deactivate ICD detection during RF energy delivery.
Cardioblate® 68000 Technical Manual
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Overview Warnings and Precautions ■
Exercise extreme caution when delivering ablation energy in close proximity to implanted leads.
■
Perform complete implantable device testing before and after ablation.
Electrosurgery near flammable materials – The risk of igniting flammable gases or other materials is inherent in electrosurgery and cannot be eliminated by device design. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of high frequency surgery. There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. Any fluid pooled in these areas should be mopped up before RF surgical equipment should be used. Attention should be called to the danger of ignition of endogenous gases. 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.
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.
■
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.
■
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.
Handling RF devices during therapy – The generator is capable of delivering significant RF energy. Do not touch the ablation electrode of the ablation device or the dispersive electrode or both electrodes on a bipolar device while operating the generator.
Cardioblate® 68000 Technical Manual
M948371A001 Rev. 1A
1-7
cardioblate_1_EN.fm
Medtronic Confidential CS0017
7/21/11 1:15 pm
7 x 9 inches (178 mm x 229 mm)
Chapter 1 Warnings and Precautions Equipment failure – The failure of the generator or hand piece could result in an unintended increase of output power. See Chapter 4, “Safety Shutdown and Troubleshooting,” for detailed information.
Generator Operation High impedance – Monitor the device impedance measurement display during RF energy delivery. If abnormally high impedance is observed, examine the ablation electrode for coagulum. If coagulum is present or any irrigation opening is found to be blocked, remove coagulum or replace the ablation device prior to continuing the procedure. If high impedance is preventing ablation from occurring, do the following: ■
Check all connections.
■
Check for obvious defects or misapplication of the dispersive electrode (if the monopolar device is in use).
■
If a patient must be repositioned during a procedure, verify that there is proper contact between the patient and the dispersive electrode after the patient has been moved.
Low impedance – Some patients may have an abnormally low impedance between the ablation device and dispersive electrode, causing a safety shutdown. Moving the dispersive electrode to a location on the body that is farther from the device may correct this situation. Fan – Do not obstruct the cooling fan located on the rear of the generator (Figure 2-5). Obstruction of the cooling fan could result in over-heating and device shutdown.
Cardioblate® Ablation Device Use See Directions for Use for Cardioblate® ablation devices being used during the procedure.
Medical Environment Line-powered equipment – Properly ground all line-powered equipment used on or in the vicinity of the patient. An ablation device connected to an RF generator constitutes a direct, low-resistance current pathway to tissue, including the myocardium. 1-8
M948371A001 Rev. 1A
Cardioblate® 68000 Technical Manual