NT-500 Operators Manual Aug 2007

NT-500 RF Lesion Generator ™ 1-1 OPERATORS MANUAL

1

GENERAL INTRODUCTION WITH WARNINGS AND CAUTIONS

The NT-500 has been designed to offer the full range of features required to perform Radiofrequency denervation. The front panel has been ergonomically designed and allows the clinician direct manipulation of the controls. Each functional effect of the device is defined within its own discrete area. It is designed for safe use in a doctor’s office, surgery centre or hospital environment. Linear Bar Displays are used to facilitate immediate visual interpretation of temperature, RF current and RF voltage, and digital displays are used for impedance, stimulate voltage and lesion time. The NT-500 has full electronic interlocking to prevent accidental switching to lesion power and stimulation voltage. The internal settings of the machine have been factory set and should not be adjusted except by approved technicians authorised by the company. The machine is designed for use with NT-500 Thermocouple Probes only. The use of probes from other manufacturers could give serious errors in the temperature reading and may compromise the safety of the patient, and would negate the warranty. Regularly inspect the accessories of the NT-500, in particular electrode cables should be checked for possible damage to the insulation. The accessories are not appropriate for endoscopic use. Warnings A warning indicates a potentially harmful situation to yourself or others. Ensure you read this Operators Manual before operating the NT-500. 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. DO NOT use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 1-2 OPERATORS MANUAL

Should the power cord or plug become cracked, frayed, broken or otherwise damaged, it must be replaced immediately. If the equipment has in any way suffered mechanical damage, it should be returned to the Supplier for Inspection and Test before further use. The power cord should always be unplugged before cleaning or service. The operator should not perform any servicing of the equipment. Any servicing should only be performed by qualified personnel. EXPLOSION HAZARD: - This equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air, oxygen or nitrous oxide. EXPLOSION SHOCK HAZARD:-Always turn the equipment off before cleaning and DO NOT allow ANY fluid to enter the ventilation holes or sockets. ELECTRIC SHOCK HAZARD:- DO NOT touch any exposed wiring or conductive surface while cover is off and the equipment is energised. The voltage present when the electric power is connected to the equipment can cause injury or death. NEVER wear a grounding wrist strap when working on energised equipment. FUSE REPLACEMENT:- For continued protection against fire hazard, replace only with same type and rating of fuse as displayed on the rear Serial Number Plate. When carrying out treatment take care to avoid the following risks:RISK OF RF BURNS TO PATIENT:- Ensure the patient does not come into contact with metal parts of the table and its accessories – antistatic sheeting recommended. RISK OF RF BURNS TO PATIENT: - Avoid skin to skin contact between different parts of patient’s body (for example between the arms and the body of the patient, or between legs) – use dry gauze if necessary. RISK OF RF BURNS TO PATIENT: - Avoid using physiological monitoring equipment during a procedure – if monitoring is required, monitoring electrodes should be placed as far as possible from the NT-500 cannula. Monitoring devices which use needle electrodes are not recommended. RISK OF RF BURNS TO PATIENT: - Position all cables to the NT-500 cannula and dispersive plate in such a way to avoid contact with the patient or other leads. INTERFERENCE WITH ACTIVE INPLANTS: - Check whether the patient has a cardiac pacemaker or any other active implant. A possible hazard exists because interference with the action of the pacemaker may occur or the pacemaker may be damaged. In case of doubt, obtain qualified advice. Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 1-3 OPERATORS MANUAL

INTERFERENCE WITH OTHER EQUIPMENT: - During RF Treatment procedures the radiated electrical fields may interfere with other electrical medical equipment. (See Section 2.5 to Minimise Electromagnetic Interference) USE OF FLUIDS: - Ensure that if fluids (saline etc.) are being used during a procedure they should be positioned away from the NT-500. RISK OF RF BURNS TO PATIENT; - In Lesion Mode select the lowest possible power for intended purpose. RISK OF RF BURNS TO PATIENT: - Check the Dispersive (Neutral) Lead and the Dispersive Pad before applying power to the patient. PROBES: - Use only “NT-500 “probes. Cautions A CAUTION indicates a condition that may lead to equipment damage or malfunction. DO NOT Activate the output of the NT-500 until the probe is properly positioned in the patient. DO NOT Remove the top cover of the NT-500, as it will expose voltage which can cause injury or death. Servicing of the equipment in accordance with the appropriate service manual. This process 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. To reduce risk of electrical shock DO NOT remove the back panel of the NT-500. Refer servicing to qualified personnel. When cleaning the outer casing of front panel of the equipment DO NOT use abrasive agents or solvents. If erratic readings of voltage, current or impedance or temperature are observed, the procedure should be halted until a determination of the source is identified. If at any time the device is behaving erratically, turn the RF Power off.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 2-1 OPERATORS MANUAL

2

TECHNICAL DATA

2.1

SPECIFICATION

SIZE Width 12” Height 6 ½“ Depth 14½”

(300mm) (160mm) (365mm)

WEIGHT 15.20 lbs

(6.90kg)

ELECTRICAL USA

110 volt 60Hz Fused 2 Ampere on live and neutral

UK

230 volt 50Hz Fused 1 Ampere on live and neutral

Rated Power Consumption

100 Watts

The power supply is built to Class II standard. The instrument is not connected to mains earth. (Class II BF).

Medical Equipment

0473

!

With respect to electrical shock fire and mechanical hazards only in accordance with UL60601-1, IEC60601-1, CAN/CSA C22.2 No 601.1 and IEC60601-2-2 CE mark Attention: Consult accompanying documents

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 2-2 OPERATORS MANUAL

STANDARDS

This instrument complies with EN 60601-1: 2003 IEC 60601-1-2: 2001 IEC 60601-2-2: 1998 IEC 60601-1-4:

IMPEDANCE Measuring frequency

53 KHz approx

Digital Display

0-2000 Ohms (in 1 ohm steps)

Accuracy

± 5% ± 10 Ohms

Digital Display Reading

Digital display reads biological impedance

STIMULATION Voltage Amplitude

Continuously variable between 0 - 3 volts ±10%. The voltage supplied is displayed on the Digital Meter in 0.01 Volt steps.

Accuracy

± 10 %

Pulse Rates

2 (Motor) (pulses per second) 50 or 100 (Sensory) (Default 110v units 50Hz and 100 Hz for 230 V units)

Pulse Rate Accuracy

±5%

Pulse Width

1mSec ± 10 %

Waveform

Biphasic pulses. Negative pulse leading

Lamp Indicator

Green LED flashes at pulse rate according to the switch which has been selected (Motor or Sens) Indicator only lights when output is present.

Safety Interlock

When stimulate Mode is selected Stimulation Voltage cannot be delivered unless the Stimulate Output Voltage Control is first set to the “Off” position (fully anticlockwise). A buzzer will sound if this is attempted.

RF LESION POWER RF frequency Document Number 111/00 Operators Manual

NT-500 Lesion Generator

480 KHz (±10%) sine wave August 2007

NT-500 RF Lesion Generator ™ 2-3 OPERATORS MANUAL

Power Output

Continuously variable. Maximum power output 25 Watts into 200 Ohms.

Voltage Indication

Bar Graph 0 -80 Volts RF

Current Indication

Bar Graph 0-800mA RF

Lamp Indicator

Amber Lesion Power LED Flashes when Lesion Power is being delivered

Audible Tone

When Lesion is complete an audible tone will sound until the RF Output control is turned off (fully anticlockwise)

Pulsed / Pulse Dose Pulse Temp limit Pulse Dose Limit

(Optional When ordering unit) RF bursts of 20mS at a frequency of 2.0 Hz 42º C (option of no limit when ordering) 42º C

Pulsed RF Option (optional when ordering unit) If the unit has the option to perform a procedure using Pulsed RF the concept is the same as conventional RF lesions, except that the Physician selects the pulsed option by pressing the “Pulsed” button. In Pulsed RF Mode the unit will deliver a Burst of RF 20mS long at a frequency of 2 pulses per second. The default temperature limit is set to 42ºC (or no limit as ordered with unit) And the default time is set to 120 seconds. The physician can select other time options from the “Time / Count” button these are 120, 240, 30, 60, and 90 seconds The sensory and motor stimulation should be carried out to ensure the correct placement of the electrodes. When the physician is satisfied that the electrode is in the correct position. Select the RF Output button and rotate the Control anticlockwise until the RF Voltage indicator reads 45 volts It should be noted that this is not performing a Thermal Lesion in pulsed RF Mode, and it is quite normal for the Temperature to not reach the 42ºC setting. The perfect treatment delivers 45 volt pulses for the full duration of the treatment. If the 42ºC limit is reached the NT-500 will reduce the width of the RF Burst until the temperature is below 42ºC. Below 42ºC the pulse will return to 20 mS full width pulses.

Pulse Dose Option

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

(optional when ordering unit)

August 2007

NT-500 RF Lesion Generator ™ 2-4 OPERATORS MANUAL

Pulse Dose delivers a pre determined number of full 20mS bursts of RF. Set the RF output to 45 volts on the RF Voltage indicator. If the unit temperature reaches 42ºC then the counter will stop and no further Pulses will be delivered, until the temperature falls below 42ºC at this point the count will continue until the counter reaches the set limit. As only full pulses are being delivered the physician can set the number of pulses from 240 (Default) 360, 480, or 120. This removes the variables of other Pulse applications and ensures repeatable results. To Use Pulse Dose (optional when ordering unit) Set up the NT-500 to enable the electrode to be placed as for a conventional lesion. Carry out the sensory and motor stimulation tests until the Physician is satisfied with the placement of the electrode. Make an X-Ray record for the patient file and prepare the patient for the procedure. Press the Pulsed button and if required change the number of pulses by pressing the Time/Count button. The count will cycle through the option of count numbers release the button when the count number is reached. Select RF Output and rotate the RF Output control anticlockwise until the RF volt indicator reads 45 volts and press the Start button. The counter will count down to zero, if the temperature goes above 42ºC, the count will stop until the temperature is below 42ºC. The count will resume at this point until the process is complete. At the end of the procedure the power will be switched off and a tone will sound. To stop the tone set the RF Output to the off position LESION TIMER Time Start

Time Indicator Lesion Time

The timer will start after the Timer start button is pressed, At the end of the procedure an alarm tone will sound and RF power is removed from the output. The timer resets to the default setting. The Alarm tone can be stopped by turning the RF output Control off. (Fully anticlockwise) Clock indicates the amount of time remaining for lesioning. Defalt is 60 Seconds

Timer/Count Count Pulse Dose Audible Indicator

Time set button cycles 30, 60, 90, 120 and 240 seconds (Pulsed RF Version) default 120 Seconds Count set cycles 120, 240, 360, and 480 counts (Pulse dose Version) default 240 Seconds A one second “tick” indicates the clock is operating.

TEMPERATURE MONITOR Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 2-5 OPERATORS MANUAL

Meter Range

Temperature set Modes

30ºC to 100º C Bar Display The Bar Display has 3 colour segments 30ºC - 42ºC Amber 42ºC - 95ºC Green 95ºC - 100ºC Red The lesion Temperature can be selected from the front panel buttons 70, 80, and 90ºC (Default setting 80ºC)

Probes

Use only NT-500 probes - no individual adjustment necessary.

Thermocouple Indicator

LED shows Green when probe is connectedor Red when disconnected or faulty.

SAFETY FEATURES Safety Cut Out

Power

Safety Interlock

2.2

RF Power is automatically reduced if temperature reaches set limit as determined by Maximum Temperature Control, (either 70ºC, 80ºC or 90ºC). RF will automatically proceed again once the temperature of the tip of the probe drops1ºC. a)

RF Power cannot be delivered unless the RF Power Control is first set to the OFF position, this prevents any accidental application of the RF power. If the lesion power is selected and power control is on, a warning tone is given out and no RF Power is provided to the probe.

b)

The Lesion Power will also be cut off if any of the conditions listed below occur. a) Measured temperature goes above 95ºC b) RF Power Oscillator detects a short circuit or low patient impedance.

EARTH LEAKAGE DATA

Tests carried out as per IEC 601-1 Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 2-6 OPERATORS MANUAL

Typical 1

2

3

4

5

6

Enclosure leakage current Normal Reverse Single Fault condition Normal Reverse Patient Leakage Current Normal (AC) Reverse (AC) Single Fault condition Normal (AC) Reverse (AC) Patient Leakage Current Normal (DC) Reverse (DC) Single Fault Condition Normal (DC) Reverse (DC) Patient Auxiliary Leakage Normal (AC) Reverse (AC) Single Fault condition Normal (AC) Reverse (AC) Patient Auxiliary Leakage Normal (DC) Reverse (DC) Single Fault condition Normal (DC) Reverse (DC) Patient Leakage Floating Type Normal Reverse Single Fault condition Normal Reverse

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

Max Allowable

40 microamps 40 microamps

100 microamps 40 microamps

40 microamps 40 microamps

500 microamps 500 microamps

4 microamps 4 microamps

100 microamps 100 microamps

4 microamps 4 microamps

500 microamps 500 microamps

4 microamps 4 microamps

10 microamps 10 microamps

4 microamps 4 microamps

50 microamps 50 microamps

4 microamps 4 microamps

100 microamps 100 microamps

4 microamps 4 microamps

500 microamps 500 microamps

4 microamps 4 microamps

10 microamps 10 microamps

4 microamps 4 microamps

50 microamps 50 microamps

25 microamps 25 microamps

5000 microamps 5000 microamps

25 microamps 25 microamps

5000 microamps 5000 microamps

August 2007

NT-500 RF Lesion Generator ™ 2-7 OPERATORS MANUAL

2.3

ENVIRONMENTAL CONDITIONS Transport Temperature Humidity Pressure

-10ºC to 70ºC 0 to 95% RH Non condensing 140-760mmHg (0 to 12,200 metres) (0 to 40,000 ft)

Storage Temperature Humidity Pressure

10ºC to + 60ºC 10 to 80% RH 520-760mmHg

(0 - 3000 metres) (0 -10,000 ft)

Operating Temperature Humidity

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

10ºC to 40ºC 10 to 80% RH

August 2007

NT-500 RF Lesion Generator ™ 2-8 OPERATORS MANUAL

2.4

ACCESSORIES SUPPLIED

1

Mains Lead

1

Dispersive Plate Lead

8

Fuses

1

Operators Manual

1

Basic Operating Procedures.

A range of Temperature Monitoring Probes, Cannula and Dispersive Plates are available from Neurotherm Inc – address given in section 7. Note When ordering the NT-500 the customer should specify the options required for the unit, These are:1) Pulsed RF With fixed 42ºC limit 2) Pulsed RF With no temperature limit Or the option of Pulse Dose 3) Pulse Dose

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 2-9 OPERATORS MANUAL

2.5

MINIMISING ELECTROMAGNETIC INTERFERENCE

Although the NT-500 meets the EMC requirement for a device of this type, it is good practice to follow certain guidelines to minimise the risk of interference between the NT-500 and other devices. 1

Do not twist the cables from the NT-500 with those of other devices.

2

Unless absolutely necessary, avoid putting the NT-500 on top of other operating equipment or other operating equipment on top of the NT-500.

3

The NT-500 generates 480 KHz at up to 25 watts during the RF Lesion Treatment phase. If any interference occurs to other equipment, it will be most noticeable under this condition.

To check this, connect a NT-500 Test Box, (set at 200 ohms) into the machine, turn to full power and observe any reading changes or interference on other equipment. To minimise any interference, position the machine as far apart as the source and the device being interfered with.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-1 OPERATORS MANUAL

3

DESCRIPTION OF CONTROLS

3.1

OPERATING PANEL LAYOUT

The front panel of the NT-500 machine is segmented into four main panels.

1. Standby Mode 2. Stimulate Mode 3. Lesion Mode 4. Displays

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-2 OPERATORS MANUAL

3.1.1 STANDBY MODE

STANDBY

On switching on the NT-500 the machine goes into ‘STANDBY’ MODE and the LED on STANDBY Button is lit. In this mode the machine can read the Impedance of the patient.

TIME/COUNT

The time/count button is used to set the the time for the Lesion or Pulsed RF. For a Pulse Dose unit unit the time/count button, sets the Count number of full RF pulse bursts

START

The ‘TIMER START’ Button is only active when the NT-500 is switched to ‘LESION MODE’ and is used to start the timer.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-3 OPERATORS MANUAL

3.1.2

STIMULATE MODE

STIMULATE

The ‘STIMULATE’ Button is used to select the STIMULATE Mode. When this mode is active the LED on the button is lit.

SENS 50Hz

When the Stimulate Mode is selected, the SENS mode is also selected- this mode gives a stimulation frequency of 50 pulses/second When this mode is active the LED on the button is lit.

SENS 100Hz

To select 100Hz press 100 Hz button When this mode is active the LED on the button is lit.

MOTOR

When the NT-500 is in Stimulate Mode the Motor Mode can be selected and gives a stimulation frequency of 2 pulses/second. STIMULATE OUTPUT CONTROL The Stimulate Output controls can be used to adjust the Stimulation Output. Up to 3.0 volts can be applied. The voltage supplied is displayed on the Stimulate Display.If when the Stimulate Function is selected and Stimulate Output Control is not in its OFF position no Stimulate voltage will be supplied to the probe. The Stimulate Output Control needs to be turned to OFF position before power can be applied. When a Stimulate Rate has been selected the LED will flash at appropriate rate in the selected button. Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-4 OPERATORS MANUAL

3.1.3

LESION MODE

Lesion

The ‘LESION’ Button is used to select the LESION Mode. When this mode is active the LED on the button is lit.

70ºC

When the NT-500 is in lesion mode the 70ºC can be selected This mode will limit the temperature at which treatment is given to 70ºC.

80ºC

When the Lesion Mode is selected the 80ºC Mode is also selected – this mode will limit the temperature at which treatment is given to 80 ºC.

90ºC

When the NT-500 is in Lesion Mode the 90ºC Mode can be selected- this mode will limit the temperature at which treatment is given to 90ºC.

Pulsed

Selects Pulsed RF or Pulse Dose depending on the units Specified Mode of operation (See ordering options)

RF Output Control

The RF Output Control controls the supply of radio frequency power to the lesioning probe. The power is variable from 0 - 25 watts. The RF Output Control must initially be in the OFF position (fully anticlockwise) otherwise no lesion power can be delivered and an alarm will sound. When power is being delivered, the Lesion Power Amber LED will flash and the RF Current and Voltage meters will indicate the amount of RF Current and Voltage being delivered.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-5 OPERATORS MANUAL

When carrying out a Treatment, the RF Output Control is slowly turned up, and the power delivered will produce a temperature rise at the treatment site – this will be seen on the temperature display.Once the site temperature is near the selected treatment temperature (70ºC, 80ºC or 90ºC) as selected by the buttons, the Timer Start button is pressed and the timer counts down to zero at which point the RF Power is removed and an alarm sounds.The RF Output Control needs to be turned off (fully anticlockwise) to silence the alarm. NOTE: - WHEN CARRYING OUT A TREATMENT THE 70ºC, 80ºC AND 90ºC TEMPERATURE LIMITS ARE SAFETY LIMITS AND SHOULD NOT BE USED TO CONTROL THE TEMPERATURE OF THE LESION EXCEPT WHEN BEING CONTINUOUSLY OBSERVED BY THE OPERATOR.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-6 OPERATORS MANUAL

3.1.4

DISPLAYS

The Displays occupy the top section of the Front Panel and comprise. RF Voltage and Current Displays These 10 segment bar meters show the amount of electrical voltage and current being delivered to the lesion site. (These displays are only active on the Lesion Mode) Temperature Display

This 30 segment bar meter shows the Temperature at the Lesion site. It is a three colour display. 30º C - 42ºC Amber 42º C - 95º C Green 95º C - 100º C Red (This Display is only active in the Lesion Mode)

Impedance Display

This 3½ digit display shows the impedance measurement between the tip of the probe and the dispersive plate. The readout is in ohms. It should be noted that this measurement is of biological impedance. (This Display is only active in the Standby Mode)

Stimulate Display

This 3 digit display shows the Stimulate Output Voltages in a range of 0- 3.0 volts. (This display is only active in the Stimulate Mode)

Time/Count

Displays the time set for the Lesion or Pulsed RF For a Pulse Dose unit the number of pulse counts will be displayed.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007

NT-500 RF Lesion Generator ™ 3-7 OPERATORS MANUAL

Mains on LED

This Green LED is illuminated if all the power supplies in the NT-500 are correct. If this LED fails to light check the internal fuses by removing the rear panel and checking the LEDs on the Fuse Board.

Thermocouple LED

This LED shows the status of the Probe. If it shows: Green – the thermocouple is connected and operational. Red – the thermocouple is either disconnected or faulty.

Lesion Power LED

This Amber LED will flash when RF Power is being delivered to the patient.

Document Number 111/00 Operators Manual

NT-500 Lesion Generator

August 2007