CARDIOBLATE® 68000
SURGICAL ABLATION SYSTEM
Technical Manual
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 i
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
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 iii
iv Cardioblate® 68000 Technical Manual
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 1-5
Adverse Events 1-10
2 Generator Description 2-1
Components 2-2
Displays, Connectors, and Controls 2-3
Audible Tones 2-9
Specifications 2-9
Output Power Diagrams 2-12
Electromagnetic Emissions and Immunity Declaration
(EN60601-1-2) 2-14
Applicable Standards 2-18
3 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
Verifying Generator Recognition of Attached Devices 3-8
Disconnecting the Cardioblate
Setting the RF Energy Mode and Parameters 3-9
Monopolar Mode Selection and Use 3-9
Bipolar Mode Selection and Use 3-14
Options 3-17
Powering Down the Generator 3-23
®
Ablation Device 3-6
®
Ablation Devices 3-9
4 Safety Shutdown and Troubleshooting 4-1
Safety Shutdown Conditions 4-2
Safety Shutdown Messages 4-3
Cardioblate® 68000 Technical Manual v
Other Messages 4-7
System Shutdown 4-7
5 Device Maintenance and Service 5-1
Replacing the Generator Fuse 5-2
Cleaning the Generator 5-2
Periodic Technical and Safety Inspection 5-3
Service 5-4
6Warranty6-1
Medtronic Warranty Information 6-2
A Index A-1
vi Cardioblate® 68000 Technical Manual
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
and the accessories that compose the Cardioblate
Generator
®
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
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.
®
68000 Generator.
Cardioblate® 68000 Technical Manual vii
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
■
Spanish
■
French
■
Italian
■
Greek
Note: At any time, the backwards arrow button can be used
to return to a previous screen.
Cardioblate® 68000 Technical Manual ix
x Cardioblate® 68000 Technical Manual
System Description 1-2
Indications for Use 1-4
Contraindications 1-5
Warnings and Precautions 1-5
Adverse Events 1-10
Overview1
1
Cardioblate® 68000 Technical Manual 1-1
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
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.
®
surgical ablation
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:
■
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.
1-2 Cardioblate® 68000 Technical Manual
Package Contents
1
3
2
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.
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
Figure 1-1. 68000 Generator
Cardioblate® 68000 Technical Manual 1-3
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
Caution: Cardioblate
be used with the Cardioblate
Caution: Only use Medtronic
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 cm
IEC 60601-2-2).
■
Model 60889 - Medtronic® Cardioblate® Diagnostic Kit
®
68000 Generator as an external device
®
bipolar device, Model 60821, cannot
®
68000 Generator.
®
ablation devices and
2
(must be compliant with
Indications for Use
The Cardioblate® Surgical Ablation System is intended to ablate
cardiac tissue during cardiac surgery using radiofrequency
energy.
1-4 Cardioblate® 68000 Technical Manual
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
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.
Overview
Contraindications
®
Surgical Ablation System
®
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 1-5
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:
■
Keep external sources of pacing and defibrillation available
during ablation.
■
Deactivate ICD detection during RF energy delivery.
1-6 Cardioblate® 68000 Technical Manual
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 1-7
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 Cardioblate® 68000 Technical Manual
Overview
Warnings and Precautions
Necessary environment – Ablation procedures should be
performed only by trained personnel in a fully equipped operating
room as follows:
■
An emergency cardiovascular team should be available during
the ablation procedure in case of a cardiovascular emergency.
■
The ablation device should be used only by or under the
supervision of physicians trained in cardiac surgery and
experienced in surgical ablation procedures.
Generator storage temperature – If the generator has been
stored at temperatures greater than 30°C or less than 15°C, allow
the generator to reach room temperature or wait at least
60 minutes before use, whichever is greater.
Fluid ingress – The generator may not function correctly if the
electronic circuitry or the connectors are wet; note the following:
■
Do not allow any fluid or moisture into the generator or any
connector or cables.
■
Do not hang fluids above the generator.
■
Do not immerse the cables into fluids.
Electromagnetic interference (EMI) – EMI produced by the
generator during normal operation may adversely affect the
performance of other equipment.
Please refer to applicable standards for additional information.
Cardioblate® 68000 Technical Manual 1-9
Chapter 1
Adverse Events
Adverse Events
The potential adverse events related to the use of ablation
systems include, but are not limited to, the following:
■
tissue perforation
■
extension of extracorporeal
bypass
■
perioperative heart rhythm
disturbances (atrial and/or
ventricular)
■
postoperative embolic
complications
■
pericardial effusion or
tamponade
■
injury to the great vessels
■
valve leaflet damage
■
conduction disturbances
(SA/AV node)
■
acute ischemic myocardial
event
■
thrombus formation
■
nerve damage
■
unintentional burns
■
pericarditis
■
pleural effusion
■
esophageal perforation
■
death
■
coronary sinus
perforation
■
coronary artery spasm
■
atrial lead dislodgement
■
hypotension
■
pulmonary vein stenosis
■
cerebrovascular accident
■
transient ischemic attack
■
blood loss
1-10 Cardioblate® 68000 Technical Manual
Generator Description2
Components 2-2
Displays, Connectors, and Controls 2-3
Audible Tones 2-9
Specifications 2-9
Output Power Diagrams 2-12
Electromagnetic Emissions and Immunity Declaration
(EN60601-1-2) 2-14
Applicable Standards 2-18
2
Cardioblate® 68000 Technical Manual 2-1
Chapter 2
3
4
5
2
1
6
7
8
9
Components
Components
Introduction
The Model 68000 Cardioblate® Generator (Figure 2-1) is
lightweight and portable with state of the art electronics and design
features that provide the user with a safe and effective
Cardioblate
®
Surgical Ablation System.
Front View Back View
Figure 2-1. Model 68000 Cardioblate® Generator Case
The following are the basic user components:
1. Bezel Light Panel
2. USB Port
3. Transport Handle
4. Display Release Button
5. Display Screen
6. Therapy Connector Panel
7. Cooling Fan
8. Optional Device Connector
9. AC Power Panel
At the top of the cover assembly there is a bezel light panel with
three LEDs: two blue and one green. When the center green LED
is lit, it indicates that the AC power is on. When the two blue LEDs
are flashing, the generator software is performing its self-test.
When the blue LEDs are solid, RF energy is being applied and a
lesion is in progress.
2-2 Cardioblate® 68000 Technical Manual
Displays, Connectors, and Controls
1
3
4
2
Displays, Connectors, and Controls
Right Side Panel
The applicable Medtronic® Cardioblate® surgical ablation devices
and the dispersive electrode cable can be connected to the
Cardioblate
on the right side of the generator.
1. Cardioblate
This multipin connector provides the interface to a bipolar ablation
device.
2. Cardioblate
This multipin connector provides the interface to a monopolar
ablation device.
®
Generator via the therapy connector panel located
Figure 2-2. Right Side Therapy Connector Panel
®
Bipolar ablation device connector
®
Monopolar ablation device connector
Generator Description
3. Dispersive electrode connector
This connector provides the interface to the dispersive electrode via
the dispersive electrode cable.
4. EGM Connection
This multipin connector provides the interface to EGM monitoring
equipment.
Cardioblate® 68000 Technical Manual 2-3
Chapter 2
USB Port
Displays, Connectors, and Controls
Left Side Panel
On the left side panel there is a Universal Serial Bus (USB) port,
which is intended for Medtronic field service personnel. It allows
the field service personnel to connect a USB flash memory device
to the generator. The flash memory device can be used for
uploading application updates and for downloading stored data
from the generator.
The Cardioblate
loaded via this USB port. Refer to the product literature for detailed
instructions.
®
Diagnostic Kit (Model 60889) application is also
Figure 2-3. USB Port location
2-4 Cardioblate® 68000 Technical Manual
Touch Screen Display
1
2
3
4
5
6
7
8 9
10 11 12
Display Screen
The color (640x480 pixels), liquid-crystal-display (LCD) screen
closes into the case for storage and flips open on a hinge for use.
The display screen provides users with real-time treatment
information in graphical and digital formats. The screen’s hinge
allows adjustment for different viewing angles. When the
generator is on, the screen also remains on at all times and in all
positions; there is no “screen saver” mode. Figure 2-4 details the
touch screen display present upon start-up.
Generator Description
Displays, Connectors, and Controls
Figure 2-4. Touch screen display
1.
Total RF time
The cumulative amount of RF energy delivery time, since the
generator was powered ON, is displayed. The counter resets to
0:00 when the generator is powered OFF and then ON.
2.
RF timer measurement display
This displays the duration (minutes:seconds) of each RF delivery
cycle. The display automatically resets to 0:00 when the RF energy
delivery begins and measures until RF energy delivery stops. The
elapsed time of the delivered RF cycle is displayed until the next
RF cycle begins.
Cardioblate® 68000 Technical Manual 2-5
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