Table of Contents
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1
GENERAL INTRODUCTION ......................................................................................................... 1-1
General Considerations ..................................................................................................................... 1-1
Indications for Use...........................................................................................................1-2
2
WARNINGS AND CAUTIONS ....................................................................................................... 2-1
Warnings ........................................................................................................................................... 2-1
Cautions ............................................................................................................................................ 2-3
Contraindications ............................................................................................................................... 2-3
3
TECHNICAL DATA ....................................................................................................................... 3-1
Specification ...................................................................................................................................... 3-1
Earth Leakage ................................................................................................................................... 3-7
Environmental Conditions .................................................................................................................. 3-8
Minimising Electromagnetic Interference ........................................................................................... 3-8
Symbols ............................................................................................................................................ 3-9
4
UNPACKING AND ACCEPTANCE TESTING ............................................................................... 4-1
Electrical Safety Testing .................................................................................................................... 4-2
5
DESCRIPTION OF THE CONTROLS ........................................................................................... 5-1
Front Panel Keyboard Layout ............................................................................................................ 5-2
RF Lesion Operation........................................................................................................5-4
Connector Panel Layout...................................................................................................5-6
Back Panel Layout..........................................................................................................5-7
6
GETTING STARTED ..................................................................................................................... 6-1
General description of screen displays .............................................................................................. 6-1
Setting up the machine for the first time ............................................................................................ 6-8
Undertaking Simple Procedures ................................................................................................... 6-13
Motor and Sensory Stimulation........................................................................................6-15
7
MORE ADVANCED USE .............................................................................................................. 7-1
General terminology, logging, messages and simple operation ......................................................... 7-1
USB and Printing Records. ................................................................................................................ 7-1
RF Pulse Mode.................................................................................................................................. 7-6
Pulse Dose ........................................................................................................................................ 7-7
Two electrodes RF ............................................................................................................................ 7-8
Two Electrode Thermal Lesion .......................................................................................................... 7-9
Dual Electrode Operation ................................................................................................................ 7-10
Dual Electrode Lesion ..................................................................................................................... 7-12
Caution ............................................................................................................................................ 7-12
Simplicity II and III Procedure Mode...................................................................................7-13
Three Electrode RF...................................................................................................... 7-13
Document 109.00
NEUROTHERM RADIO FREQUENCY LESION GENERATOR
OPERATORS MANUAL
TABLE OF CONTENTS
®
MODEL NT1100
10September2012 Issue 06
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Table of Contents
Summary of Contents for NeuroTherm NT1100
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Page 1: Table Of Contents
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL TABLE OF CONTENTS GENERAL INTRODUCTION ......................1-1 General Considerations ........................1-1 Indications for Use……………………………………………………………………………………………..1-2 WARNINGS AND CAUTIONS ....................... 2-1 Warnings ............................2-1 Cautions ............................2-3 Contraindications ..........................2-3 TECHNICAL DATA ........................3-1 Specification ............................ - Page 2 List of Error / Fault Messages ......................8-1 Hierarchy of Screens ........................8-12 STERILISATION PROCEDURES ....................9-1 Cleaning Procedure for the NeuroTherm NT1100 ................9-1 PRINCIPLES OF LESIONING, TYPICAL LESION SIZES AND BASIC PROCEDURES ..... 10-1 Principles of Lesioning ........................10-1 Simplicity II and Simplicity III Procedure Addendum ..............
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Page 3: General Introduction
At the end of a patient session a patient record is printed out on the NeuroTherm printer. This printer is not electrically connected to the NeuroTherm, but gets its information via a ‘Bluetooth’ wireless link. -
Page 4: Indications For Use
OPERATORS MANUAL Indications for Use The NT1100 is intended for use to create lesions in neural tissue. The NT1100 is to be used with separetly approved lesion/temperature probes such as NeuroTherm radiofrequency probes, Smith & Nephew Spinecath and Acutherm catheters, and Radionics DiskTrode radiofrequency probes. -
Page 5: Warnings And Cautions
Warnings A warning indicates a potentially harmful situation to yourself or others. Ensure you read this Operators Manual before operating the NeuroTherm. HAZARDOUS ELECTRICAL OUTPUT - The equipment is for use ONLY by qualified medical personnel. DO NOT under any circumstances perform any Testing or Maintenance on the equipment while it is being used on a patient. - Page 6 NeuroTherm cannula. Monitoring devices which use needle electrodes are not recommended. RISK OF RF BURNS TO PATIENT: - Position all cables to the NeuroTherm cannula and dispersive plate in such a way to avoid contact with the patient or other leads.
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Page 7: Cautions
In monopolar applications, ensure that the Dispersive or return electrode is connected to the patient and to the NeuroTherm. Do not remove the top cover of the NeuroTherm, as it will expose voltage which can cause injury or death. Servicing of the equipment in accordance with the appropriate service manual should never be undertaken in the absence of proper tools, test equipment and the most recent revision of the service manual which is clearly and thoroughly understood. - Page 8 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Relative • Patients using anti-coagulants whose treatment can be suspended temporarily, or in whom bleeding can be rapidly and readily reversed, should it occur. • Patients using pacemaker equipment. •...
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Page 9: Technical Data
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL TECHNICAL DATA Specification SIZE Width 400 mm (15 ¾”) Height 300 mm (11 ¾”) Depth 415 mm (16 ½”) WEIGHT 12.5 Kg. (28 lbs) ELECTRICAL Europe 230 Volt 50Hz – 60Hz Fused 1 Amp on live and neutral... - Page 10 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL IMPEDANCE Measuring Frequency 53 KHz (± 3KHz) Measuring Source Voltage Less than 500 mV AC Measurement Display 50-2000 ohms (one ohm resolution) Accuracy ± 5% Features Internal 500 ohm Test Resistor...
- Page 11 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Features Hardware and Software lockout if voltage / current control not initially set to zero Warning on screen if stimulation control is not initially at zero. Flashing LED on front panel indicates machine is...
- Page 12 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Auto Mode With Lesion Power Control Off, the procedure can be carried out under Automatic control by pressing the ‘Auto start’ button. The temperature will ramp up at 8°C per second and time will start when the measured temperature is within 5°C of desired temperature.
- Page 13 The Simplicity II procedure is complete after the tone sounds and the RF is switched off See Addendum on NT1100 Simplicity II and III Section Number 10-11. Document 109.00...
- Page 14 Only accessible by service engineers for keyboard + mouse Any equipment connected to rear socket must comply with IEC60950 and IEC60601-1 Use only parts supplied by NeuroTherm Ltd. Any other parts will void the warranty and may cause danger to the patient. Document 109.00...
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Page 15: Earth Leakage
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Earth Leakage Typical Maximum Allowable Enclosure leakage current Normal 40 microamps 100 microamps Reverse 40 microamps 100 microamps Single Fault Condition Normal 40 microamps 500 microamps Reverse 40 microamps 500 microamps... -
Page 16: Environmental Conditions
(The return addresses are shown in section 11-1 of this manual). Minimising Electromagnetic Interference Although the NeuroTherm NT1100 meets the EMC requirements for a device of this type, it is good practice to follow certain guidelines to minimise the risk of interference between the NeuroTherm and other devices. -
Page 17: Symbols
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Symbols The following symbols are displayed on the machine and the meaning of them is shown below ETL Mark Attention: Consult accompanying documents Floating output (not connected to ground) 0086 CE mark Document 109.00... -
Page 18: Unpacking And Acceptance Testing
Do not attempt to alter the voltage selector on the rear of the machine. This is for factory setting only. Place the NeuroTherm on a flat surface, connect the machine into the mains and switch on using the ON/OFF switch on the rear of the machine. The following will be observed:... -
Page 19: Electrical Safety Testing
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Electrical Safety Testing If an Automatic or Manual Electrical Safety Analyser is used, the following settings must be used: Machine Class: Class II Type BF To test the various leads of the output, use the following plugs:... -
Page 20: Description Of The Controls
OPERATORS MANUAL DESCRIPTION OF THE CONTROLS The NeuroTherm NT1100 viewed from the front is shown below In operation, control of the generator is via a Front Panel Keyboard and the screen will show the current settings of the machine, what is being delivered to the patient and any error or warning messages. -
Page 21: Front Panel Keyboard Layout
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Front Panel Keyboard Layout The keyboard is divided into 3 segments: Stimulate RF Power Control Stimulate Section This section consists of:- 2 buttons- ‘Sensory’ and ‘Motor’ each of which contains an integral green LED... - Page 22 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL The frequency, voltage or current range are selected in the original setup of the machine for both sensory and motor functions and these will be indicated on the display together with the actual amplitude of the stimulation being delivered to the patient.
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Page 23: Rf Lesion Operation
OPERATORS MANUAL RF Lesion operation The NT1100 has a unique heating algorithm for multi electrode heating control The algorithm senses the difference in the heating capacity between the different electrodes, and will be able to deliver different amounts of power to each electrode. - Page 24 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Control Section This section consists of: 1 pair of ‘Select’ buttons 2 other buttons ‘Log’ and ‘End Session’ 1 Mains LED The Up/Down Select Buttons are used under certain stimulation modes to select options that appear on the Display Screen.
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Page 25: Connector Panel Layout
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Connector Panel Layout Dispersive Socket This 4mm socket is for the lead of the Dispersive Patient Plate which should be at least 135 sq cm (21 square inches) Test Socket... -
Page 26: Back Panel Layout
Fuses and Voltage Changes The NeuroTherm is protected by two in-line fuses, one on the live line and one on the neutral line. These fuses are located to the right hand side of the IEC socket. The fuses are 20mm Anti-Surge to BS 4265. - Page 27 Contact Address If the NeuroTherm requires a routine service or in the unlikely event of the machine malfunctioning, the contact address of NeuroTherm Ltd is shown on the back plate. The full address, telephone and contact details are shown in Section 11.
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Page 28: Getting Started
OPERATORS MANUAL GETTING STARTED The NeuroTherm NT1100 is a Generator set up by its touch screen and operated by its Membrane Front Control Panel. From the “Procedure Setting” screen the Doctor can select the parameters they want to use, for the treatment of a patient, which are then stored by the machine. - Page 29 MODEL NT1100 OPERATORS MANUAL Touch Screens & System Navigation The NeuroTherm NT1100 uses a touch screen to allow the user to navigate through menus, input Data and setup key options parameters. Setting the date and time functions. From the welcome screen select the “Options” button.
- Page 30 At the bottom of all screens there is a long white bar, which shows information of the Software version number, Shot Number, Log Number, and Patient Name The log number is a unique number that is automatically created by the NT1100 for every session.
- Page 31 OPERATORS MANUAL Entering & Storing Doctor Details The NT1100 has the capability to record and store twelve Doctor detail profiles and set up parameters. The benefit of this system is that a Doctor can quickly and easily retrieve their preferred settings.
- Page 32 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL To recall a stored Doctor Profile use the drop down menu to select the Doctors name, or create a new Doctor profile using the ‘add’ selection. The machine has storage capacity for twelve individual profiles. If there is already twelve Doctors saved onto the machine you must overwrite a profile, by deleting the Doctor’s name...
- Page 33 Doctor or patient details select the Finish Button. Then select Doctor or patient buttons to amend the details. The NT1100 will then require the user to select the electrode they require to use for a procedure. By touching the hi lighted drop down box, the following menu will be displayed Electrode Selection Screen The Electrode selection screen gives the user the choice to select from a list of Ten options.
- Page 34 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Setting Operating Parameters The right hand side of the screen shows a series of five coloured boxes, each representing the different operational states, Sensory Stimulation, Motor Stimulation, Thermal Lesion, Pulsed RF and Pulsed Dose To enter each of the operational state menus, touch the relevant coloured box using the touch screen.
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Page 35: Setting Up The Machine For The First Time
Setting up the machine for the first time 1. Turn the NT1100 on using the power switch on the rear of the unit 2. The machine will boot, to the self- test screen, where all of the hardware is initialised and diagnostic tests are performed. - Page 36 OPERATORS MANUAL Entering Doctor Details 5. The NT1100 has the capacity to store up to twelve Doctors, each with their own user profile, which stores all preferred operating parameters. As standard the default profile is selected. To set up a Doctor profile for the first time press the drop down box next to ‘Doctor’ and select the ‘add’...
- Page 37 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 6-10 ® MODEL NT1100 OPERATORS MANUAL 7. The name of the Doctor will be filled out in the ‘Doctor’ Box. If editing of any stored parameters is required, press the ‘Doctor’ button. The next step is to press the ‘Patient’...
- Page 38 MODEL NT1100 OPERATORS MANUAL Patient details are stored between sessions. This allows the NT1100 to be switched off once all of the patient’s information has been entered without loss of entered data. This will make the situation simple if all patient details are entered for the day and a delay or problem means that all the planned sessions cannot take place on that day.
- Page 39 At the bottom of the screen is a reading of impedance at the active site. The box at the foot of the grey area shows the active site. It must be noted that during stimulation of a patient, the NT1100 will not read Impedance.
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Page 40: Undertaking Simple Procedures
The Electrode selection screen will then give the user a list of all of the electrode modes supported by the NT1100. For this example we will be performing a thermal lesion using single electrode only. To make this choice, touch the screen labelled single electrode Set up single electrode Select the “Accept”... - Page 41 On the right hand side of the screen are all of the operating parameters for the various modes on the NT1100. At this stage we will use the default parameters. Press “Accept” to go to the Motor/Sensory screen. Connecting the dispersive lead You may now plug in a dispersive lead into the far left socket on the front of the unit labelled ‘Dispersive’...
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Page 42: Motor And Sensory Stimulation
OPERATORS MANUAL Motor and Sensory Stimulation 1. The NT1100 will now have progressed to the Sensory stimulation screen. The machine is now in an active state. The control panel and not the touch screen now perform most of the activation of the NT1100. - Page 43 Dispersive electrode is connected to the patient, and that it is connected to the Dispersive connector on the NT1100 The NT1100 is now ready to apply power through the electrode in socket 1. To begin press the ‘Auto Start’...
- Page 44 ‘Stop’ button was pressed. Ending a Session Once the NT1100 enters an active state it enters what is known as a ‘session’. A session can be made up of a series of individual tasks, albeit a combination of stimulation and lesion tasks, the activity of which, being automatically logged.
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Page 45: More Advanced Use
GENERAL TERMINOLOGY, LOGGING, MESSAGES AND SIMPLE OPERATION Data Logging during a procedure The NT1100 has the capability to log and store all data from a procedure on a second by second basis. By pressing the ‘log’ button, the NT1100 saves all data simultaneously which can be printed or saved to the NeuroTherm USB memory Stick (Part #: NT-USB) at the end of the procedure. -
Page 46: Usb And Printing Records
The NT1100 has two printing options The NT1100 has always allowed the user to a print brief summery of the patient’s procedure to an optional printer as well as output of a complete data file to the memory stick. These functions have now been separated into individual selections on the File Control screen. - Page 47 Once downloaded to a personal Computer, This report can be viewed in Microsoft Word or another text file Application. The report file name will be a file number assigned by the NT1100, and matches the file number displayed within the full report.
- Page 48 “Site Labels” A site labels function is incorporated into the NT1100 that will allow the Doctors to identify each site that is to be lesioned Up to eight sites labels can be identified per session. Once a site label has been created for the procedure, it will appear on the stimulation and lesion screens, and will be incorporated into the printed reports and exported files.
- Page 49 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL HANGE SITE LABLELS DURING A SINGLE ELECTRODE PROCEDURE In singe electrode mode, the site labels should be all updated before the procedures are begun, then the Doctor can cycle through the labels during stimulation and lesions.
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Page 50: Rf Pulse Mode
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL RF Pulse Mode From the welcome screen select the “Accept” button to show the “Procedure Settings” screen 1. To access the Pulsed RF set up Menu, press the blue ‘Pulse RF’ box on the right hand side of the display. -
Page 51: Pulse Dose
NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Pulse Dose To access the Pulse Dose RF parameter Set Up Menu, press the Purple ‘Pulsed Dose’ box on the right hand side of the display in the ‘Doctor’ or “Procedure Setting” Screen. -
Page 52: Two Electrodes Rf
The procedure is now complete. Press “end session” to return to the “Procedure Setting” screen. Note In pulse Dose mode The NT1100 will deliver full 20ms Pulses of 45 volts, should the temperature exceed 42ºC the pulse will not be delivered and the counter will stop until the temperature is below 42ºC. -
Page 53: Two Electrode Thermal Lesion
When the Doctor has the electrodes in the correct position, from the sensory and motor. stimulation the lesion can be started 3. In Two Electrode RF mode, the NT1100 will only function using Auto mode. Once ready to perform the procedure, press the button. -
Page 54: Dual Electrode Operation
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 7-10 ® MODEL NT1100 OPERATORS MANUAL Dual Electrode Operation (A Dual Lesion is one that is created between two separate electrodes) 1. Dual electrode RF is also only controlled in Auto mode. It is selected at the “Procedure Setting”... - Page 55 3. In the Lesion screen the controlling electrode is shown on the graph by having the label ‘Control’ under the electrode name. Once the button is pressed the NT1100 will automatically set the control electrode and the lesion will continue until the set time is reached. Once the procedure has finished the tone will sound.
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Page 56: Dual Electrode Lesion
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 7-12 ® MODEL NT1100 OPERATORS MANUAL Dual Electrode Lesion Caution When using dual electrode mode, the operator must insure that the two electrodes are not touching, as this will prevent any heating and thus will not heat the tissue. If the electrodes are in physical contact at their exposed tips, the impedance will read 0 ohms, and a warning-short circuit will be displayed. -
Page 57: Simplicity Ii And Iii Procedure Mode
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 7-13 ® MODEL NT1100 OPERATORS MANUAL 7.13 Simplicity II and III Procedure Modes The Simplicity Procedure allows the Physician to produce a long strip lesion using a simple automated procedure and single uniquely designed electrode Note: To use the Simplicity functionality Auto Dispersive must be ON. -
Page 58: Three Electrode Rf
MODEL NT1100 OPERATORS MANUAL The Simplicity lll procedure is complete after the tone sounds and the RF is switched off See Addendum on the NT1100 Section Number 10-11 for additional detail on the Simplicity ll and Simplicity lll Functionality. 7.10 Three electrodes RF 1. - Page 59 Three Electrodes Stimulation Three Electrode Lesion 3. In Three Electrode RF mode, the NT1100 will only function using Auto mode. When the Doctor has completed the sensory and motor test, “Log “each test as required. With the electrodes in the correct place, press the “Auto Start’...
- Page 60 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 7-16 ® MODEL NT1100 OPERATORS MANUAL TESTING SITES MID-LESION Now there is the ability to test site locations if the patient experiences pain during a treatment that includes using multiple electrodes. This function is called Lesion Paused state.
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Page 61: Cordotomy
1000-ohm load with the maximum voltage not exceeding 126 Volts. In stimulate mode NT1100 will generate an audio tone that is in line with the Impedance at the probe tip. Select the audio tone from the “Options Screen” select “More” and then select Date / Time. -
Page 62: Bipolar And Two Bipolar
Control during all active modes is identical to the Two Electrode RF modes, and is only available in Auto mode. No Thermocouple Operation When the NT1100 is used with No Temperature Control Electrodes, care must be taken to ensure that the, electrode temperature is limited by the level of RF volts applied Warning... -
Page 63: Preset Step Profiles
Then press the ‘Auto Start’ button to begin the lesion. The NT1100 will automatically control the procedure, displaying the temperature and time on the graph. When the procedure completes the tone will sound and the power will switch off. -
Page 64: Custom Step Profiles
Custom Step Profiles The custom step profile facility gives the user the ability to create three lesion profiles. Custom step profiles are only supported by single electrode or dual Electrode. The NT1100 defines a step profile using the following variables: Start Temperature: The initial temperature in degrees centigrade that the profile should hold before the making the first step rise. - Page 65 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 7-21 ® MODEL NT1100 OPERATORS MANUAL 1. To access the custom step lesion firstly access the Thermal Lesion by pressing the green Thermal Lesion box on the right hand side of the display in the ”Procedure Setting” Screen.
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Page 66: Maintenance Screen
OPERATORS MANUAL Maintenance Screen Access to further functions for the NT1100 is available by selection of a Maintenance screen. From the Welcome screen press and hold the “Auto Stop” button for approximately 7-10 seconds the screen will change to show a Maintenance screen. This screen cannot be accessed until a password is entered and the login accepted. - Page 67 At the Welcome screen select “Options” then select “Copy BMP Files” Insert USB Stick into the NT1100 USB Port. The NT1100 will chirp as each captured screen is saved to the memory stick. Wait until the Screen reverts back to the File Control Screen. The memory stick can now...
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Page 68: Error / Advice Messages
OPERATORS MANUAL ERROR / ADVICE MESSAGES If the NT1100 detects a fault or condition that the user should be advised of, it will automatically generate a message on the screen. There are 4 classifications of message, based on the severity of the operating condition: Level 1 –... - Page 69 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Level 1 - User Advice Message Scenario Message Text Message code When setting defaults in Doctor setup screen These setting will be saved as defaults 1-001 When the user presses the log button...
- Page 70 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL When the accept button is pressed in the setup No probe detected 1-020 confirmation screen with any mode selected, but Output 3 there is no probe or a faulty probe connected to...
- Page 71 When the NT1100 is printing the procedure details Printing patient record 2-001 for the patient file message will disappear after printing is finished When the NT1100 is writing the log file to the USB Writing LOG file to USB device 2-002 memory stick Time left mm:ss...
- Page 72 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Level 3 - User warning Message Scenario Message Text Message code When trying to print, but there is an error with the Printing error - check printer 3-001 printer. Fix problem, press <retry> or press <cancel> to E.g.
- Page 73 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL When the temperature goes over 98 degrees while High temperature shutdown 3-122 you are in any of the procedure screens Machine set to safe state When the auto stop button is pressed while in...
- Page 74 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL When automatically starting the RF output in Unable to deliver RF power 3-132 lesion mode with the impedance of probe 2 open circuit. Impedance open circuit on probe 1. Check probe and connection of the reference plate and restart procedure.
- Page 75 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL When manually starting the RF output in any Unable to deliver RF power 3-139 mode with the impedance of probe 3 less than 50 Ohms Impedance is lower than 50 Ohms on probe 3.
- Page 76 NEUROTHERM RADIO FREQUENCY LESION GENERATOR ® MODEL NT1100 OPERATORS MANUAL Probe 1 reached temperature fault with stimulate Unable to deliver stimulation 3-146 control turned on in any mode Probe 1 has been disconnected or may have a fault. Turn off stimulation control, check probe and...
- Page 77 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 8-10 ® MODEL NT1100 OPERATORS MANUAL Level 4 - Critical fault Message Scenario Message Text Message code An un recognized error has occurred #900000 Fuse error - A fuse has failed #100001 Impedance error. Impedance measurement is out of #100002 tolerance.
- Page 78 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 8-11 ® MODEL NT1100 OPERATORS MANUAL Lesion automatic interlock failed to trigger, #500008 hardware set safe Invalid parameters passed to pulsed RF state #600001 Invalid sub state entered #600002 Invalid parameters passed to Pulsed dose state...
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Page 79: Hierarchy Of Screens
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 8-12 ® MODEL NT1100 OPERATORS MANUAL Hierarchy of Screens Document 109.00 10September2012 Issue 06... -
Page 80: Sterilisation Procedures
Note: It is advised that sterilization equipment should have validation certification and performance qualification tests undertaken of their process cycles for efficient processing. Cleaning Procedure for the NeuroTherm NT1100 Wipe with a soapy water solution do not use solvents or bleach on any part of the machine. For extreme contamination isopropyl alcohol can be used, but it may smear the touch screen and should be followed by a wipe of soapy water. -
Page 81: 10 Principles Of Lesioning, Typical Lesion Sizes And Basic Procedures
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-1 ® MODEL NT1100 OPERATORS MANUAL 10 PRINCIPLES OF LESIONING, TYPICAL LESION SIZES AND BASIC PROCEDURES Principles of Lesioning 10.1.1 The basic physical principles of radiofrequency ablation Figure 10.1 shows the fundamental radiofrequency circuit. The RF lesion generator or power source provides a source of RF. - Page 82 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-2 ® MODEL NT1100 OPERATORS MANUAL the frequency of the RF current. It is this radio frequency motion which causes the ions to rub against the surrounding fluid medium, causing friction which results in the tissue heating. The temperature at any point is controlled by the frictionally induced power dissipation at that point, mediated by thermal diffusion and thermal convection.
- Page 83 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-3 ® MODEL NT1100 OPERATORS MANUAL Figure 10.3 Figure 10.3 shows a schematic diagram of the temperature of the tissue as a function of distance from the electrode tip. It should be noted that the temperature is not isotropic for a non-spherical electrode, and thus these curves may differ at different orientations on a non-spherical electrode tip.
- Page 84 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-4 ® MODEL NT1100 OPERATORS MANUAL to inconsistent results, and resulted in the acknowledgment of the equilibrium lesion size as being the optimum methodology. It is noteworthy that impedance monitoring has a great value in assessing the progress of a heat lesion.
- Page 85 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-5 ® MODEL NT1100 OPERATORS MANUAL It is a natural reaction to think of pulsed radiofrequency as being analogous to the neural modulation effects achieved using spinal cord stimulators or TENS units. However, these two modalities are very different.
- Page 86 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-6 ® MODEL NT1100 OPERATORS MANUAL Figure 10.7 There is very little conclusive research to date on the mode of action of PRF. A few preliminary studies have shown that a modification of CFOS and DNA expression has been observed in cells of rat DRG after exposure to PRF.
- Page 87 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-7 ® MODEL NT1100 OPERATORS MANUAL The following diagrams depict the different modes- Figure 10.8 shows Historical Pulsed RF-amplitude control- Figure 10.8 The beginning pulses are the desired pulses of 45 volts amplitude and 20 ms duration. Note that the moment the set temperature limit is reached the voltage is changed (reduced) in order to keep the temperature below this limit.
- Page 88 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-8 ® MODEL NT1100 OPERATORS MANUAL Figure 10.9 shows Historical Pulsed RF- pulse width control Figure 10.9 When the temperature limit is reached the pulse width is changed as opposed to the pulse amplitude. Note that the pulse width is changed the moment the temperature limit is reached, the width is varied to keep the temperature below the temperature limit.
- Page 89 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-9 ® MODEL NT1100 OPERATORS MANUAL Figure 10.10 Pulse Dose- a new more consistent approach Figure 10.10 Figure 10.10 In the pulse dose mode, only amplitudes that are the full set voltages and widths that are the full set pulse width are delivered.
- Page 90 10.11 Simplicity II and Simplicity III Addendum NT1100 Radio Frequency Generator This addendum to the NT1100 Radio frequency Generator Operator’s Manual explains the updates and added features for software and introduces two additional Electrode Procedure Options with Simplicity ll and Simplicity lll.
- Page 91 Electrode 1 is displayed on the left, with Electrode 2 being displayed on the right. Stimulation is done as in two electrode mode. Refer to NT1100 Manual sec. 9.5 Multiple Electrode Lesioning for lesion temperature and time settings. Press “Lesion”...
- Page 92 First a dual lesion is made between electrode one and two. Each graph shows the temperature of each electrode. The NT1100 will control the temperature of each probe automatically. At the top left of the screen there is a read out of time remaining until the end of the procedure.
- Page 93 Stimulation” screen. Note each electrode has its own graphical area. Stimulation is done as in three electrode mode. Refer to NT1100 Manual sec. 9.5 Multiple Electrode Lesioning for lesion temperature and time settings. Press “Lesion” Electrode 1 is displayed on the left, with Electrode 2 in the middle and Electrode 3 being displayed on the right.
- Page 94 Each graph shows the temperature of each electrode. The NT1100 will control the temperature of each probe automatically. At the top left of the screen there is a read out of time remaining until the end of the procedure.
- Page 95 NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-15 ® MODEL NT1100 OPERATORS MANUAL Next a Single lesion is created at electrode one. Next a Single lesion is created at electrode two. Finally a Single lesion is created at electrode three. At the end of the procedure the Unit will sound a tone and turn off the RF Power Document 109.00...
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Page 96: Typical Heat Lesion Sizes
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 10-16 ® MODEL NT1100 OPERATORS MANUAL Typical heat lesion sizes Typical lesion sizes are categorized below in figures 10.11, 10.12, and 10.13, for different tip temperatures, tip exposures and needle gauges. Though lesion size can vary considerably depending on tissue electrical and thermal conductivity, presence of heat sinking by blood, and thermal insulation such as the presence of bone, some qualitative observations can be made. -
Page 97: Basic Procedures For Stimulation And Lesion
To use the basic default settings follow the “Seven Steps Procedure” 10.3.2 Seven Steps Stimulation and Lesion Procedure Step 1 Switch on power to the NT1100 (wait for self test) Step 2 “Accept” Default Profile (ensure the settings are correct for the procedure) Step 3 “Accept”... -
Page 98: 11 Maintenance
OPERATORS MANUAL 11 MAINTENANCE Each time the NeuroTherm NT1100 is switched on, the computer within it carries out a number of self tests. These tests not only check the operation of the machine but also the performance of the Impedance and RF Functions. Should any of these fail, the NeuroTherm is automatically disabled from use. -
Page 99: 12 Ec Declaration Of Conformity
NEUROTHERM RADIO FREQUENCY LESION GENERATOR 12-1 ® MODEL NT1100 OPERATORS MANUAL 12 EC DECLARATION OF CONFORMITY Document 109.00 10September2012 Issue 06...