AngioDynamics NanoKnife User manual
ii
160-104694 Rev 01
Version 2.2.0
NanoKnife®
User Manual
Copyright © 2009-2010 AngioDynamics. All rights reserved. AngioDynamics is a
registered trademark and NanoKnife is a registered trademark of AngioDynamics with
patents pending in the United States and foreign countries.
This documentation contains proprietary information of AngioDynamics. No part of this
manual may be reproduced or transmitted in any form or by any means, electronic or
mechanical, for any purpose, without the written permission of AngioDynamics.
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CONTENTS
SECTION 1INTRODUCTION 7
1.1Overview.................................................................................7
1.2Symbols..................................................................................8
1.2.1Standard Symbols................................................................ 8
1.2.2Specific Part Symbols .......................................................... 9
1.2.3Icons .................................................................................. 10
SECTION 2SAFETY INSTRUCTIONS 11
2.1Overview...............................................................................11
2.2Safety Features of the Generator .......................................12
2.3Contraindications ................................................................12
2.4Warnings...............................................................................12
2.4.1Arrhythmia Risk.................................................................. 12
2.4.2Electrodes .......................................................................... 13
2.4.3Electrocution Hazard.......................................................... 13
2.5Precautions ..........................................................................14
2.5.1Side Effects ........................................................................ 15
SECTION 3SYSTEM COMPONENTS 17
3.1Overview...............................................................................17
3.2Generator Description.........................................................18
3.2.1Generator Front/Right Side Elements ................................ 18
3.2.2Generator Front/Lower Panel Elements............................. 19
3.2.3Generator Power Unit’s Back/Lower Panel Elements ........ 20
3.2.4Generator Back Handle...................................................... 21
3.2.5Equipment and Supplied Components............................... 21
3.2.6LCD Display Controls Description ...................................... 22
3.2.7LCD Display Settings ......................................................... 23
3.2.8Console Components......................................................... 24
3.2.9Electrode Probe Components ............................................ 25
SECTION 4INSTALLATION AND START UP27
4.1System Location ..................................................................27
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4.2Generator Start-Up and Warm-Up......................................28
SECTION 5OPERATION 31
5.1 Overview...............................................................................31
5.1.1 Table of Buttons.................................................................. 32
5.1.2Information Screen............................................................. 34
5.1.3Probe Selection Screen ..................................................... 40
5.1.4Probe Placement Process Screen ..................................... 46
5.1.5 Pulse Generation Screen ................................................... 58
5.1.6Ablation Delivery ................................................................ 60
5.1.7Additional information......................................................... 67
SECTION 6EXTERNAL ECG SYNCHRONIZATION 71
6.1 Overview...............................................................................71
6.2External R-Wave Detector...................................................71
SECTION 7PROBES AND ABLATION AREA 77
7.1Electrode Probes .................................................................77
7.2Ablation Area .......................................................................77
SECTION 8TROUBLE SHOOTING 79
8.1Overview...............................................................................79
8.2 Documented Problems and Solutions...............................80
8.3 Error Messages....................................................................81
SECTION 9MAINTENANCE AND SERVICE 83
9.1 Overview...............................................................................83
9.2Preventive Maintenance and Periodical Verifications .....84
9.3Cleaning................................................................................84
9.4Replacing Main Fuses .........................................................84
SECTION 10TECHNICAL DATA 87
10.1General Information.............................................................87
12.1Power Supply Specifications..............................................87
12.2Fuse Type Specifications....................................................88
10.4Environmental Conditions ..................................................88
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10.4.1 Operating Conditions ...................................................... 88
10.5 Classifications ....................................................................88
10.6Use Conditions ...................................................................89
10.7Technical Specifications.....................................................89
10.8Radio Frequency Identification .........................................90
SECTION 11WARRANTY AND ELECTROMAGNETIC COMPATIBILITY 91
11.1Warranty ..............................................................................91
11.2Electromagnetic Compatibility...........................................91
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SECTION
INTRODUCTION
1.1 Overview
The NanoKnife System transmits non-thermal energy from the
NanoKnife Generator to electrodes placed in a target area. The
electrodes work in a two-pole operating mode, and up to six
electrodes can be placed at a fixed distance apart in soft tissue
to create several two-pole electrode configurations.
Intended Use: The NanoKnife System with six outputs is
indicated for surgical ablation of soft tissue.
Components
The NanoKnife System includes multiple components. The first
component of the system is the Generator. The Generator
operates outside of the sterile field. The second component of
the NanoKnife System is a Footswitch for the Generator. The
footswitch connects to the Generator and also operates outside
the sterile field. The last component of the NanoKnife System is
the single-use, disposable Electrode. The electrodes operate in
the sterile field and are packaged and shipped sterile. The
NanoKnife System has six probe outputs, which allow Users to
connect up to six electrodes at one time. Only one pair can be
operated at a time. See Section 5.1"System Operation" for
more details.
Sections
The NanoKnife User Manual contains Sections that are
progressive. Read this User Manual thoroughly before operating
the system. Do not hesitate to contact your local supplier or the
manufacturer in case of doubt on the correct usage of the
system.
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1.2 Symbols
As with any custom software, the NanoKnife System uses specific symbols and icons. The
following is a list of the standard symbols and icons used in this manual. All of the symbols
used on the NanoKnife System are in conformity with CEI 62-5 Directives.
1.2.1 Standard Symbols
SymbolMeaningLocation
BF Applied Parts (Output separated
from earth)
Printed on the data plate, on
Generator’s back panel.
Protection Ground Outlet
Marks protection ground. Check inside
the device.
Dangerous High Voltage
Marks every part inside the Generator
where a dangerous High-Voltage
potential difference might be present,
except main voltage.
Caution: Indicates that the User
should read the accompanying
documentation in order to
understand and/or correctly use the
part marked by the symbol.
On the LCD display and data plate
Open: When a main switch is
pressed in the position marked by
this symbol, the Generator is
switched OFF.
Printed on the main switch
I
Closed: When a main switch is
pressed in the position marked by
this symbol, the Generator is
switched ON.
Printed on the main switch
Alternating Current: Indicates the
kind of current required to be
supplied.
Printed on the data plate
Generator and all its parts should be
disposed of according to local
regulation for disposal of electronic
devices.
Printed on the data plate
Manufactured By
Printed on the data plate
Keep Dry
Printed on the crate label
Transport and Storage Temperature
Printed on the crate label
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SymbolMeaningLocation
Defibrillator Proof (Body protected) Printed on the front of the Generator in
between the probe connectors
Federal Communications
Commission
Printed on the data plate
European Conformity Marking with
notified body identification number
Printed on the data plate
1.2.2 Specific Part Symbols
Symbol Meaning Location
USB Port Connector, for USB
storage device (e.g., USB Flash
Drive). It is not recommended to
connect any other kind of device.
On the side of the console
Console Power ON Indicator
It is lit when the Console is turned
ON.
Above console’s keyboard
Caps Lock Keyboard Indicator
If lighted, the keyboard writes in
capital letters.
Above console’s keyboard
HDD
Hard Disk Driver Status Indicator
It is intermittently lighted when the
Hard Disk Driver is operating.
Above console’s keyboard
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1.2.3 Icons
Icons are image files that are meant to resemble the task you wish to complete and will
launch that task when "clicked" or are graphical User interface elements that provide
options.
IconFunctionDescription
GeneratorUser login icon
Radio or Option Button
Various procedure screens on the console
allow the User to choose only one of a
predefined set of options. When the User
selects a radio button, any previously
selected button in the same group becomes
deselected.
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SECTION
SAFETY
INSTRUCTIONS
2.1 Overview
The Generator must be operated by trained personnel only.
The Safety Instructions included in this manual are divided into
"Warnings" and "Precautions":
Warnings are safety instructions that, if neglected, might lead to
serious adverse events involving the patient, User, any other
person or the environment.
Precautions are safety instructions that, if neglected, might lead
to undesired events, of marginal or negligible severity, that might
involve the patient, User, any other person, or might lead to a
failure of the device.
Federal or USA law restricts the use of the system by or on the
order of a physician.
Intended Use: The NanoKnife System with its six outputs is
indicated for the surgical ablation of soft tissue.
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2.2 Safety Features of the Generator
The Generator incorporates the following safety features to assist the User in delivering a
safe application:
a. Output Current Restriction
When the Generator senses that the current between the electrodes exceeds
the operating parameters, the pulses are aborted. This safety feature protects
against applying output energy that exceeds maximum current settings.
b. Double Trigger Foot Pedal
The system incorporates a double trigger foot pedal system that prevents
accidental delivery of procedure pulses. The foot pedals require the User to
first arm the system by depressing the "Arm" foot pedal, and then sequentially,
depressing the "Pulse" foot pedal within 10 seconds of arming to deliver energy
to the patient.
c. Test Pulse
After electrodes are placed and prior to the procedure, the Generator sends a
low-energy test pulse to the ablation site to confirm the tissue impedance is
within an acceptable range. This prevents initiating a procedure if the probes
are too far apart or too close together.
2.3 Contraindications
Procedures based on high-voltage pulses are not recommended in the following cases:
•Ablation of lesions in the vicinity of implanted electronic devices or implanted
devices with metal parts.
•Ablation of lesions of the eyes, including the eyelids.
•Patient history of Epilepsy
•Recent history of Myocardial Infarction.
2.4 Warnings
2.4.1 Arrhythmia Risk
•Patients with Q-T intervals greater than 550 ms (milliseconds) are at an
increased risk for inappropriate energy delivery and arrhythmia. Verification of
proper function of a synchronization device before initiating energy delivery is
essential in these patients.
•Asynchronous energy delivery (240 PPM (Pulses Per Minute) or 90 PPM
modes) might trigger atrial or ventricular fibrillation, especially in patients with
established arrhythmias or structural heart disease. Ensure that interventions
(defibrillator, etc.) and appropriately trained personnel are readily available for
dealing with cardiac arrhythmias.
•Using QRS synchronization devices whose output is not compatible with the
specifications listed in this manual may result in ventricular fibrillation.
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•Patients with established arrhythmias (i.e., Atrial Fibrillation, PVC’s) should be
carefully monitored for proper synchronization during energy delivery.
•Adequate precautions should be taken for patients with implantable electrical
devices.
2.4.2 Electrodes
•To avoid risks of infection for the patient and for the operators, always maintain
the electrodes’ protective packaging (cap, tubes, etc.) when the electrodes are
not placed in the patient.
•To preserve the electrode’s sterility do not remove the electrodes from the
packaging until the User is ready to apply the electrode to the patient.
•Do not use the electrodes after the expiration date printed on their packaging.
Observe the electrodes manufacturer’s specific instructions (e.g., printed on the
electrodes’ packaging).
•Only use AngioDynamics electrode probes with the NanoKnife System
Generator (BF Applied Parts Classification).
•Maintain electrical separation of the electrodes from safety ground by doing the
following:
a. Disconnect any electrode from the Generator that is not applied to the
patient.
b. Avoid any clamping of the electrode’s cable, unless explicitly instructed or
authorized by the electrode’s manufacturer.
c. Do not connect any devices (e.g., measurement) to the electrodes unless
they have been supplied by and specifically indicated for such a use by the
manufacturer.
2.4.3 Electrocution Hazard
•Electrocution Hazard! The Generator internally produces voltages that are
dangerous and may be fatal. The Generator does not contain parts serviceable
by the User, and should not be opened.
•Do not use the Generator in the presence of flammable or explosive gas
mixtures.
•For electrical safety, the Generator needs grounding. Use only medical level
main power supply cords, e.g., those supplied by the manufacturer.
•The Generator should be used by trained personnel only.
•Before plugging the Generator to the main, ensure that the main power cords
are not damaged. Replace them if any damage is noticed—main cords cannot
be repaired.
•Do not connect or disconnect the Generator from the main power cord with
wet hands.
•Confirm that the main power cord will be connected to a properly grounded
electrical outlet.
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•Whenever necessary, replace Generator fuses only with spare fuses specified
in this manual, see Section.
•Maintenance should be carried out only by trained personnel. The Generator
must undergo periodic preventative maintenance as specified in the
Maintenance and Service section.
•The NanoKnife User Manual is a fundamental part of the Generator and should
always accompany it. Users must refer to this manual for correct and complete
information on the use of the Generator.
2.5 Precautions
•Electrodes that are not parallel to each other may result in an incomplete
ablation.
•Inappropriately positioned electrodes or metal implants in the field may distort
the desired IRE ablation field.
•Read this User Manual thoroughly before operating the Generator. Do not
hesitate to contact your local supplier or the manufacturer in case of doubt on
the correct usage of the Generator.
•Electrodes are subjected to potentially harmful electric energy. Do not touch
the metal part of the electrodes while a procedure is in progress.
•The effects of IRE on a fetus are not known. Procedure on pregnant women
should be contemplated only after ensuring that the procedure benefits
outweigh the risks.
•Procedure safety and efficacy may be affected if electrodes other than those
supplied by AngioDynamics or by an authorized distributor are used.
•Unless there is a reasonable doubt that a site has been ablated ineffectively,
repeating an ablation on the same site is not advisable, since it is not believed
to increase procedure efficacy.
•Avoid unnecessarily high voltage or excessive number of pulses.
•Use of operator-defined parameters increases the risk of ineffective procedures
or post-procedure complications, with respect to validated standard
procedures.
•Avoid short-circuiting the electrodes when delivering pulses. Electrode to
electrode contact or electrode to electrode spacing less than 5 mm
(millimeters) may result in short circuiting during energy delivery resulting in
incomplete ablation.
•Ensure the Generator is connected to the proper main power supply value (see
Section 9.4 and that the main power supply outlet is able to supply the required
power.
•Do not use the Generator if a malfunction is suspected. Contact the
manufacturer or the local authorized supplier.
•Avoid intentional or accidental spilling of liquids on the Generator. In particular,
do not keep containers of liquids on the Generator. Do not handle the
equipment with wet hands.
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•Store the Generator away from direct sunlight, heat sources, and dust; in
particular, do not expose the LCD display to direct sunlight for long periods of
time.
•Respect environmental operating and storing conditions, as specified in
Section 10.4. Ensure that nothing obstructs the ventilation grids, which are on
the rear panel of the Generator and also under the console, in order to allow
the correct ventilation of the internal circuits.
•Avoid moving the device when powered ON. Avoid jarring the equipment
during transport.
•Avoid scratching the LCD display.
•Before carrying out any cleaning of the device, power it OFF and disconnect
the main cord from the Generator.
•Turn OFF the Generator before connecting external devices.
•Connect only devices complying with relevant regulations.
2.5.1 Side Effects
Side effects of procedures based on the administration of high-voltage pulses are reported
in literature. These include involuntary muscle contraction at the time of the electric pulse,
which stops at the end of the pulse.
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SYSTEM
COMPONENTS
3.1 Overview
The NanoKnife System Generator utilizes single-use disposable
electrode probes to transmit energy from the Generator to a
target ablation area.
The Generator Trolley in
Figure3‐1includes the following:
•LCD Display
•Console and Keyboard
•Power Unit and Power Cord
•Double Footswitch/Foot Pedal
SECTION
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Figure 3-1: Generator Trolley
3.2 Generator Description
The User’s interaction with the Generator is similar to utilizing a personal computer; the User
operates the Generator through the console and LCD display. The console includes a
conventional keyboard with Power-On, Caps Lock and Hard Disk Drive function light
indicators, a touch pad with two buttons, and two USB ports located on the right side panel.
The details of the Generator front/right sides, including the console are shown in Figure 3-2
while the names of the Generator elements are listed in Table3‐1.
3.2.1 Generator Front/Right Side Elements
Table 3-1: Generator Front/Right Side Elements
Figure 3-2: Generator Front/Right Side Elements
Figure
3‐2Component Description
1LCD Display Displays a graphic User
interface
2Display Control
Button
Adjusts the display
settings
3Keyboard
Serves to input data
and interact with
generator
4Indicators Show current status o
f
the generator
5Tray Provides a place for
needed equipment
6Side Pockets
Designed as a
container for the pedal,
electrodes and other
accessories, such as
the manual
7Front Wheel
Brakes
Each front wheel is
supplied with a lever to
stop the wheel; a
lowered lever stops the
wheel, a raised lever
frees the wheel
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3.2.2 Generator Front/Lower Panel Elements
There are four front/lower panel elements of the Generator as shown in Figure 3-3 and
described in Table 3-2.
Figure 3-3: Generator Front/Lower Panel Elements
Table 3-2: Generator Front/Lower Elements
Refer to
Figure3‐3Component Description
1
Six Electrode Connectors
Plug-in for electrodes
2Red Stop Button identified
by the label "STOP"
When pressed, internally disconnects the
electrode connectors. Allows interruption of
procedure without removing electrodes from the
patient. Accumulated energy in the power
component is discharged. Rotate clockwise to
release.
3Stop Button status
indicator
When lighted indicates that Stop button is
released and procedure can commence. If NOT
lighted, the Stop button is engaged and unit is in
safety mode. Stop button must be released to
proceed with procedure.
4
Pedal Connector,
identified by the label
"Input Pedal"
Connection for the double trigger foot pedal
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3.2.3 Generator Power Unit’s Back/Lower Panel Elements
The power unit of the Generator performs all procedure activity for ablation delivery and
measurement. The operator interacts with the power unit through the double foot pedal that
starts the procedure. Figure 3-4 and Table 3-3 provide details on the Generator’s back view
features. The back panel of the Generator’s power unit incorporates the power supply switch
and connectors for the power supply unit and external synchronization of the ablation.
Figure 3-4: Generator Power Unit’s Back/Lower Panel Elements
Table 3-3: Generator Power Unit’s Back/Lower Panel Elements
Refer to
Figure 3-4 Component Description
1Power Supply GroupGroups the main switch, cord connector and
protection fuses slide
2Protection Fuses SlideInsertion site for protection fuses; allows
selection of the main voltage
3Main SwitchTurns the Generator ON/OFF
4Cord ConnectorConnects the main power supply cord
5Appliance Data Plate
Indicates the unit name, model, serial number,
manufacturer, power supply specifications, and
power fuse specifications
6External Sync Connector
Connects an external synchronization device
e.g., QRS detection device
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