User Manual
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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 1
INTRODUCTION 1.1
Overview ... 7
1.2
Symbols ... 8 1.2.1 1.2.2 1.2.3
SECTION 2
11
2.1
Overview ... 11
2.2
Safety Features of the Generator ... 12
2.3
Contraindications ... 12
2.4
Warnings... 12
2.5
Arrhythmia Risk ... 12 Electrodes ... 13 Electrocution Hazard ... 13
Precautions ... 14 2.5.1
Side Effects ... 15
SYSTEM COMPONENTS
17
3.1
Overview ... 17
3.2
Generator Description ... 18 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9
SECTION 4
Standard Symbols ... 8 Specific Part Symbols ... 9 Icons ... 10
SAFETY INSTRUCTIONS
2.4.1 2.4.2 2.4.3
SECTION 3
7
Generator Front/Right Side Elements ... 18 Generator Front/Lower Panel Elements ... 19 Generator Power Unit’s Back/Lower Panel Elements ... 20 Generator Back Handle ... 21 Equipment and Supplied Components ... 21 LCD Display Controls Description ... 22 LCD Display Settings ... 23 Console Components ... 24 Electrode Probe Components ... 25
INSTALLATION AND START UP 4.1
System Location ... 27 3
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4.2
SECTION 5
Generator Start-Up and Warm-Up ... 28
OPERATION 5.1
31
Overview ... 31 5.1.1 Table of Buttons ... 32 5.1.2 Information Screen ... 34 5.1.3 Probe Selection Screen ... 40 5.1.4 Probe Placement Process Screen ... 46 5.1.5 Pulse Generation Screen ... 58 5.1.6 Ablation Delivery ... 60 5.1.7 Additional information ... 67
SECTION 6
SECTION 7
SECTION 8
SECTION 9
SECTION 10
EXTERNAL ECG SYNCHRONIZATION 6.1
Overview ... 71
6.2
External R-Wave Detector ... 71
PROBES AND ABLATION AREA
77
7.1
Electrode Probes ... 77
7.2
Ablation Area ... 77
TROUBLE SHOOTING
79
8.1
Overview ... 79
8.2
Documented Problems and Solutions ... 80
8.3
Error Messages ... 81
MAINTENANCE AND SERVICE
83
9.1
Overview ... 83
9.2
Preventive Maintenance and Periodical Verifications ... 84
9.3
Cleaning ... 84
9.4
Replacing Main Fuses ... 84
TECHNICAL DATA
87
10.1
General Information... 87
12.1
Power Supply Specifications... 87
12.2
Fuse Type Specifications... 88
10.4
Environmental Conditions ... 88 4
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10.4.1
SECTION 11
Operating Conditions ... 88
10.5
Classifications ... 88
10.6
Use Conditions ... 89
10.7
Technical Specifications ... 89
10.8
Radio Frequency Identification ... 90
WARRANTY AND ELECTROMAGNETIC COMPATIBILITY 11.1
Warranty ... 91
11.2
Electromagnetic Compatibility ... 91
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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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S E C T I O N
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
Symbol
Meaning
Location
BF Applied Parts (Output separated from earth)
Printed on the data plate, on Generator’s back panel. Marks protection ground. Check inside the device. Marks every part inside the Generator where a dangerous High-Voltage potential difference might be present, except main voltage.
Protection Ground Outlet Dangerous High Voltage
I
Caution: Indicates that the User should read the accompanying documentation in order to understand and/or correctly use the part marked by the symbol. Open: When a main switch is pressed in the position marked by this symbol, the Generator is switched OFF. Closed: When a main switch is pressed in the position marked by this symbol, the Generator is switched ON. Alternating Current: Indicates the kind of current required to be supplied. Generator and all its parts should be disposed of according to local regulation for disposal of electronic devices.
On the LCD display and data plate
Printed on the main switch
Printed on the main switch Printed on the data plate
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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Symbol
Meaning
Location
Defibrillator Proof (Body protected)
1.2.2
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
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
Hard Disk Driver Status Indicator HDD
It is intermittently lighted when the Hard Disk Driver is operating.
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Above console’s keyboard
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. Icon
Function
Description
Generator
User 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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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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S E C T I O N
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. 12
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2.4.2
•
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.
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. 13
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2.5
•
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.
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. 14
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2.5.1
•
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.
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
Figure 3-1 includes the following: •
LCD Display
•
Console and Keyboard
•
Power Unit and Power Cord
•
Double Footswitch/Foot Pedal
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S E C T I O N
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 Table 3-1. 3.2.1
Generator Front/Right Side Elements Table 3-1: Generator Front/Right Side Elements
Figure 3-2 1
LCD Display
2
Display Control Button
3
Keyboard
4
Indicators
5
Tray
6
Side Pockets
7
Front Wheel Brakes
Figure 3-2: Generator Front/Right Side Elements
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Component
Description Displays a graphic User interface Adjusts the display settings Serves to input data and interact with generator Show current status of the generator Provides a place for needed equipment Designed as a container for the pedal, electrodes and other accessories, such as the manual Each front wheel is supplied with a lever to stop the wheel; a lowered lever stops the wheel, a raised lever frees the wheel
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
Component
Figure 3-3 1
2
3
4
Description
Six Electrode Connectors Plug-in for electrodes When pressed, internally disconnects the electrode connectors. Allows interruption of Red Stop Button identified procedure without removing electrodes from the by the label "STOP" patient. Accumulated energy in the power component is discharged. Rotate clockwise to release. When lighted indicates that Stop button is released and procedure can commence. If NOT Stop Button status lighted, the Stop button is engaged and unit is in indicator safety mode. Stop button must be released to proceed with procedure. Pedal Connector, identified by the label Connection for the double trigger foot pedal "Input 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
1
Power Supply Group
Groups the main switch, cord connector and protection fuses slide
2
Protection Fuses Slide
Insertion site for protection fuses; allows selection of the main voltage
3
Main Switch
Turns the Generator ON/OFF
4
Cord Connector
Connects the main power supply cord
5
Appliance Data Plate
Indicates the unit name, model, serial number, manufacturer, power supply specifications, and power fuse specifications
6
Connects an external synchronization device External Sync Connector e.g., QRS detection device
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3.2.4
Generator Back Handle
Back Handle – Assists when moving the Generator. The Generator can be lifted from the handle to move it over an obstacle. It is also suitable for winding the Main Power Supply Cord around, see Figure 3-5.
Figure 3-5: Generator Back Handle
3.2.5
Equipment and Supplied Components
Table 3-4 lists the Generator components and supplied quantities. Table 3-4: Equipment and Supplied Components
Quantity
Component
1
Generator
1
Double Foot Pedal
1
Power Cord
Optional
Electrodes (Purchased separately)
NOTE: The Double Foot Pedal is an essential part of the NanoKnife. It is graded IPX-8. It is recommended to use only genuine parts supplied by the NanoKnife’s manufacturer or authorized distributor.
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