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                            NEUROTHERM RADIO FREQUENCY LESION GENERATOR

                        3-1 

MODEL NT1100

®

 

OPERATORS MANUAL 

 

Document 109.00

 

 

 10September2012 Issue 06

 

3 

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 

USA/Canada 

110 Volt  60Hz – 50Hz  Fused 2 Amp on live and neutral 

Other 

220 Volt     60Hz   

Fused 1 Amp on live and neutral  

Voltage change via rear connector 

Power Consumption 

150 watt 

The power supply is built to Class 2 Standard. The mains transformer and all mains 
related parts are double insulated from the Main Enclosure. The mains Transformer 
has separate isolated bobbins for mains and low voltage windings. Thermal fuses 
(rated to fail at 125° C) are fitted into all primary and secondary windings. 

The machine is not connected to mains earth (class 2). 

STANDARDS

 

This machine complies with: 

EN 60601-1 : 1997 
IEC 60601-1-2 : 1993 
IEC 60601-2-2 : 1998 
IEC 60601-2-10 : with Canadian deviations 

With respect to electrical shock, fire and mechanical hazards only in accordance with 
UL 60601-1, IEC 60601-1, CAN/CSA C22.2 No. 601.1 and IEC 60601-2-2 

Содержание NT1100

Страница 1: ...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...

Страница 2: ...8 ERROR ADVICE MESSAGES 8 1 List of Error Fault Messages 8 1 Hierarchy of Screens 8 12 9 STERILISATION PROCEDURES 9 1 Cleaning Procedure for the NeuroTherm NT1100 9 1 10 PRINCIPLES OF LESIONING TYPICA...

Страница 3: ...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...

Страница 4: ...012 Issue 06 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 radiofr...

Страница 5: ...ment Any servicing should only be carried out by qualified personnel EXPLOSION HAZARD This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen...

Страница 6: ...RFERENCE WITH ACTIVE INPLANTS Check whether the patient has a cardiac pacemaker or other active implant A possible hazard exists because interference with the action of the pacemaker may occur or the...

Страница 7: ...ch is clearly and thoroughly understood To reduce risk of electrical shock do not remove the back panel of the NeuroTherm Refer servicing to qualified personnel When cleaning the outer casing touch pa...

Страница 8: ...nduct of the procedure Co existing disease producing significant respiratory or cardiovascular compromise that may affect the safe and comfortable conduct of the procedure Immunosuppression Unrealisti...

Страница 9: ...n 150 watt The power supply is built to Class 2 Standard The mains transformer and all mains related parts are double insulated from the Main Enclosure The mains Transformer has separate isolated bobb...

Страница 10: ...dible tone is adjustable and mutable d Warning on screen if impedance is less than 50 ohms or greater than 2000 ohms STIMULATION MODE Signal Shape Biphasic square wave with negative edge leading This...

Страница 11: ...t into machine Lamp Indicator LED flashes when Lesion Power is being delivered Temperature Range Selectable 50 90 C for Thermal Lesion Default 80 C Selectable in 5 C steps in initial screen set ups Se...

Страница 12: ...with impedance are also displayed Audible Indicator An alarm tone with a volume adjustment will indicate the end of the procedure PULSE RF MODE In pulsed mode the waveform is pulsed rather than conti...

Страница 13: ...electrode lesion is performed between electrode 1 and 2 the next lesion is to electrode1 followed by a further lesion to electrode 2 There is a short time delay between lesions to allow the lesion ar...

Страница 14: ...machine is delivering power d Three output sockets to accept a variety of probes including Cordotomy optional extra and enable multiple probe operation e Hardware lockout if temperature exceeds 95 C M...

Страница 15: ...Normal DC Reverse DC Single fault condition Normal DC Reverse DC 4 microamps 4 microamps 4 microamps 4 microamps 10 microamps 10 microamps 50 microamps 50 microamps 4 Patient Auxiliary Leakage Curren...

Страница 16: ...ual 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...

Страница 17: ...OPERATORS MANUAL Document 109 00 10September2012 Issue 06 F Symbols The following symbols are displayed on the machine and the meaning of them is shown below ETL Mark 0086 CE mark Attention Consult ac...

Страница 18: ...he ON OFF switch on the rear of the machine The following will be observed a The Mains LED will light b After a few seconds during which the computer within the NeuroTherm is going through a boot sequ...

Страница 19: ...following settings must be used Machine Class Class II Type BF To test the various leads of the output use the following plugs Dispersive plug 4mm Safety Socket One of the active Plugs Lemo 4 pin Ther...

Страница 20: ...atient and any error or warning messages In set up mode when the generator is not connected to the patient the screen is transformed into a touch screen and a whole series of conditions can be set up...

Страница 21: ...tons selects that function and a green LED within the button indicates that either Sensory or Motor function has been selected The Stimulate Output Control knob is used to adjust the Stimulation ampli...

Страница 22: ...for Time Count and Set Temp 2 other buttons Auto Start and Auto Stop Red Pressing either of the large buttons selects that function and the green LED within the button indicates that either Lesion or...

Страница 23: ...ose Mode the Time starts when the Auto Start button is pressed or RF power is applied to the patient In both Auto and Manual mode when the time set for the procedure has elapsed a warning tone is hear...

Страница 24: ...tone The Log button is used to highlight an event In the stimulate mode when a stimulation signal is being delivered to a patient a coloured bar orange for Sensory yellow for Motor is drawn on the scr...

Страница 25: ...ock for use in testing the thermocouple probes in the Stimulate Mode Probe Socket No1 This 4 pin socket is used to connect single electrodes for standard RF Lesion and Pulsed RF Lesion Procedures Prob...

Страница 26: ...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 A...

Страница 27: ...Therm Video Unit NT VD this unit provides Opto isolated connection to a remote display DO NOT CONNECT ANY OTHER DEVICE TO THIS SOCKET AS IT WILL COMPROMISE THE SAFETY OF THE PATIENT Connector C Remote...

Страница 28: ...ct the parameters by selecting the name on the Doctor Screen from the drop down list Once the machine is set up the treatment of a patient it is controlled via the front Control Panel with some adjust...

Страница 29: ...avigation 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...

Страница 30: ...ms Navigation for the selections 25 50 75 and 100 The procedure tone is a selection of when the loudspeaker will produce a tone proportional to impedance during a procedure This can be set as None Cor...

Страница 31: ...Profiles thus allowing the Doctors to set up the NT1100 to their preferred settings simply by selecting their name from the pull down list This feature can be used to 1 Create default settings for ea...

Страница 32: ...rnatively if parameters are not required to be stored the Doctor can select the default profile this recalls the standard factory parameters and any selections are not saved to the machine CAUTION Rev...

Страница 33: ...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 Scr...

Страница 34: ...0 75 100 150 180 200 Width 0 1 0 2 0 5 1 0 Volts Current 0 0 5V 0 3 0V 5 0 V 0 1 0mA 0 6 0mA 0 10 0mA Motor Stimulation Frequency 2 5 Width 0 1 0 2 0 5 1 0 Volts Current 0 0 5V 0 3 0V 5 0 V Thermal Le...

Страница 35: ...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 3 The NT1100 will then show the following screen 4 The date and...

Страница 36: ...d 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 option 6 The Doctor screen will then appear Type the Doctor s...

Страница 37: ...details will appear as screen below 9 To add a new patient press the New button to display the following screen Enter the patient s details as normal and press Accept button to add this patient to th...

Страница 38: ...for the day may be deleted in one go by selecting the delete all button on the patient s screen Once entered the new patient will be added to the patient list in the patient s screen To select a parti...

Страница 39: ...he stimulation control is turned on in Motor and Sensory modes the NT1100 creates a colour coded vertical line see above for colour table Above this line is a single digit that represents the active s...

Страница 40: ...The Doctor name and patient name will be shown in the relevant fields The electrode selection must then be made by touching the drop down box next to Electrode The Electrode selection screen will the...

Страница 41: ...ed for the given procedure For single electrode RF socket 1 and the dispersive lead are labelled active for use in this procedure On the right hand side of the screen are all of the operating paramete...

Страница 42: ...shown as a numerical reading at the top of the screen When the level of sensory stimulation is achieved press the log button The bar will remain showing the level of stimulation logged Turn the stimu...

Страница 43: ...erforming a Lesion To switch the unit to lesion mode press the button The lesion screen will appear For this quick start example we will perform an automatic thermal lesion Ensure that the correct siz...

Страница 44: ...e switched off The lesion is now complete Stopping a Procedure If at any point during a procedure it is necessary to end the procedure either in the event of an emergency or not press the button This...

Страница 45: ...l active procedures This data can be copied and used on any Microsoft windows compatible computer and viewed using Microsoft Excel For reference the files are saved as CSV comma separated value text f...

Страница 46: ...mple View Print Files will display a list of Print files any file can be selected for a detailed report select Display File button to show patient data record The options for delete selected file copy...

Страница 47: ...gned by the NT1100 and matches the file number displayed within the full report Notes The brief summery report file will be deleted from the generators memory after finish is selected The report canno...

Страница 48: ...ouch screen the labels are displayed as numbers not the entered value So site 2 will be displayed as site 2 rather than C4 RS Site labels are displayed below the graphics for stimulation and lesion Th...

Страница 49: ...e Settings screen Alternative method to update site labels e Update site labels for all sites to be lesioned f Stimulate all sites sequentially by pressing Select Up and Select Down buttons to cycle t...

Страница 50: ...gress to an active state Carry out the Stimulation and Motor sensory checks and log the results by selecting the Log Button To switch the unit to RF Pulse mode press the button The Pulsed RF screen wi...

Страница 51: ...are set in the same way to those of all other modes select the options from the drop down menus and press Accept This will return to the Procedure Setting Screen Once all parameters are set press the...

Страница 52: ...the temperature exceed 42 C the pulse will not be delivered and the counter will stop until the temperature is below 42 C The count will resume at this point to ensure the correct amount of energy is...

Страница 53: ...ill only function using Auto mode Once ready to perform the procedure press the or button Press the Auto Start button to begin the procedure Two Electrode Thermal Lesion Each graph shows the temperatu...

Страница 54: ...Document 109 00 10September2012 Issue 06 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 se...

Страница 55: ...the user has set the Auto Dispersive disconnect to ON in the Machine control Screen the warning will not appear and the Dispersive lead will be automatically disconnected when RF Lesion is selected o...

Страница 56: ...ng short circuit will be displayed The NT 1000 is short circuit protected and cannot be damaged by shorting the outputs Dual Electrode size and shapes Additionally it is important to realize the relat...

Страница 57: ...ollows The dual electrode lesion is performed between electrode 1 and 2 the next lesion is performed with electrode 1 followed by a further lesion performed by electrode 2 There is a short time delay...

Страница 58: ...10 Three electrodes RF 1 As with Two electrodes RF Three electrodes RF are only available in Auto mode It is selected at the Procedure Setting menu Highlight the choice Three electrodes and press Acce...

Страница 59: ...e press the Auto Start button to begin the lesion The RF heating has an advanced temperature control algorithm to ensure that each electrode will operate to the correct temperature even though the imp...

Страница 60: ...played Screen 1 Thermal Lesion Paused Screen 1 The user can choose one of two actions from the Thermal Paused Lesion screen where Up Select Arrow sends the NT1000 into the Lesion Paused state for test...

Страница 61: ...with the Impedance at the probe tip Select the audio tone from the Options Screen select More and then select Date Time From the Procedure Tone highlight the Cordotomy press Finish twice to return to...

Страница 62: ...trode connects to Active socket 2 or 2 and 3 with the other end of the bifurcated cable plugged into the Dispersive connector on the NT1100 Control during all active modes is identical to the Two Elec...

Страница 63: ...mal Lesion by pressing the green Thermal Lesion box on the right hand side of the display Under the drop down for Step select the requested profile and press Accept to continue to the Stimulation scre...

Страница 64: ...ore the making the first step rise Step Time The time in minutes the profile should hold at each step temperature Step Rise The increase in Temperature in degrees centigrade of each step Final Tempera...

Страница 65: ...85 90 C Final Time 1 00 2 00 4 00 6 00 8 00 10 00 Min 2 This will give the user a menu for custom step profile for the Thermal lesion Use the dropdown boxes to enter the profile variables Start Tempe...

Страница 66: ...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 th...

Страница 67: ...t Letter or A4 Printer Com Port Port 1 or Port 2 Machine Control Screen To return to the Welcome Screen Select the finish button twice Capture Screen Facility The Doctor can use the capture screen to...

Страница 68: ...in the NT1100 Level 3 User Warning User warnings are recoverable They alert the user with a central message box which will overlay any graphs menus or active screens The user will have to acknowledge...

Страница 69: ...er than 45 degrees is selected Selected temperature above 45 degrees 1 009 In Pulsed RF Pulse Dose setup screen when a voltage higher than 45 volts is selected Voltage above 45 V 1 010 In custom step...

Страница 70: ...al electrode or two bipolar electrodes is selected and you are in the procedure screen for RF lesion pulsed RF or pulse dose with the output switched off Auto start only 1 028 When custom step lesion...

Страница 71: ...stick Message will disappear after 5 sec LOG file transferred to USB device USB device xx full 2 003 When the accept button is pressed in the Doctor setup screen message will disappear after 5 sec Sa...

Страница 72: ...stimulate probe 1 Impedance probe 1 open circuit Turn off stimulate control and check probe and reference plate 3 006 Open circuit condition on Probe 2 with stimulate control turned on Unable to stim...

Страница 73: ...and machine set to safe state Press lesion to go back to procedure screen 3 126 When manually starting the RF output in any mode with the impedance of probe 1 open circuit Unable to deliver RF power...

Страница 74: ...back to procedure screen 3 134 When automatically starting the RF output in pulse mode with the impedance of probe 2 open circuit Unable to deliver RF power Impedance open circuit on probe 2 Check pro...

Страница 75: ...When automatically starting the RF output in lesion mode with the impedance of probe 3 less than 50 Ohms Unable to deliver RF power Impedance is lower than 50 Ohms on probe 3 Check probe and connecti...

Страница 76: ...h stimulate control turned on in any mode Unable to deliver stimulation Probe 3 has been disconnected or may have a fault Turn off stimulation control check probe and restart procedure 3 148 Probe 1 r...

Страница 77: ...output detected with stimulate board switched off 300005 Invalid parameters passed to sensory stimulation 300006 Invalid state reached during sensory stimulation 300007 Sensory stimulation un recogni...

Страница 78: ...cument 109 00 10September2012 Issue 06 Lesion automatic interlock failed to trigger hardware set safe 500008 Invalid parameters passed to pulsed RF state 600001 Invalid sub state entered 600002 Invali...

Страница 79: ...NEUROTHERM RADIO FREQUENCY LESION GENERATOR 8 12 MODEL NT1100 OPERATORS MANUAL Document 109 00 10September2012 Issue 06 Hierarchy of Screens...

Страница 80: ...cles Temperatures should be Pre vacuum 1320 C 2700 F for minimum of 4 minutes Gravity Displacement Gravity displacement should also be 1320 C for a minimum of 15 minutes Ensure the cable does not cont...

Страница 81: ...0 2 The active electrode with its smaller surface area has much higher field densities in the tissue adjacent to it This higher field density causes significant heating near the active electrode surfa...

Страница 82: ...45 C the 45 degree isotherm can be considered to be the outer border of the lesion since tissue within this volume will be thermally destroyed and tissue outside of this volume will experience lower...

Страница 83: ...ng was caused by the tip temperature exceeding 100 C and the subsequent gas formation at the tip to the electrode This obviously was not a controlled lesion technique and led to unpredictable and dang...

Страница 84: ...onset of boiling the impedance rises very rapidly In summary it is clear that the monitoring of temperature and impedance are both of great significance 10 1 2 Pulsed radiofrequency Historically radio...

Страница 85: ...ncy component is at two Hz and falls off as the frequency increases At frequencies above 1000 Hz the amplitude of the frequency component is getting very small There is a very different situation with...

Страница 86: ...cientific basis these parameters have been arbitrarily modified by clinicians and thus there is no consensus as to what the optimum parameters are One of the major variables in pulsed radiofrequency t...

Страница 87: ...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 vo...

Страница 88: ...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 va...

Страница 89: ...ls below the temperature limit This guarantees that every treatment delivers the full set amplitude and pulse width The number of pulses or doses are set by the operator as opposed to time thus ensuri...

Страница 90: ...ng OPTIONS from the welcome screen pressing MORE pressing AUTO DISPERSIVE pressing ON and pressing FINISH 1 Procedure Setting Screen Electrode Selection Menu Simplicity ll and Simplicity lll Electrode...

Страница 91: ...pull down menu Press Simplicity ll Electrode and it will highlight press Accept This will automatically display the Sensory Stimulation screen Note each electrode has its own graphical area Electrode...

Страница 92: ...s 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 procedu...

Страница 93: ...ode and it will highlight Then press Accept From the Procedure Settings screen press Accept This will automatically display the Sensory Stimulation screen Note each electrode has its own graphical are...

Страница 94: ...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 The graphical interface...

Страница 95: ...AL Document 109 00 10September2012 Issue 06 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 t...

Страница 96: ...ive observations can be made It is clear that the lesion shape is that of prolate spheroid where the major axis is always along the needle shaft and whose length is virtually the length of the tip exp...

Страница 97: ...ult settings or optimising the settings to their requirements 6 For a standard default procedure the electrode would be a single electrode in socket 1 7 To use the basic default settings follow the Se...

Страница 98: ...you should immediately call your local distributor Maintenance should only be carried out by authorised personnel A periodic full service on an annual basis is recommended Main Distributors In the USA...

Страница 99: ...NEUROTHERM RADIO FREQUENCY LESION GENERATOR 12 1 MODEL NT1100 OPERATORS MANUAL Document 109 00 10September2012 Issue 06 12 EC DECLARATION OF CONFORMITY...

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