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NT-500
Service manual
15 pgs1.27 Mb2
Technical guide
9 pgs83.14 Kb0
User manual
32 pgs730.34 Kb0

Neurotherm NT-500 User manual

NT-500 Lesion Generator ™
OPERATORS MANUAL
TABLE OF CONTENTS
1 GENERAL INTRODUCTION WITH WARNINGS AND CAUTIONS ................1-1
2 TECHNICAL DATA.......................................................................................... 2-1
3 DESCRIPTION OF CONTROLS...................................................................... 3-1
3.1.1 STANDBY MODE.........................................................................3-2
3.1.2 STIMULATE MODE......................................................................3-3
3.1.3 LESION MODE.............................................................................3-4
3.1.4 DISPLAYS ....................................................................................3-6
4 CHECK AND TEST PROCEDURES................................................................4-1
5 STERILISATION PROCEDURES.................................................................... 5-1
6 LESION PROCEDURES.................................................................................. 6-1
7 MAINTENANCE...............................................................................................7-1
8 UNPACKING AND ACCEPTANCE TESTING.................................................8-1
9 EC DECLARATION OF CONFORMITY ..........................................................9-1
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
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 August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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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 August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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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 August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
2-1
OPERATORS MANUAL
2 TECHNICAL DATA
2.1 SPECIFICATION
SIZE
Width 12” (300mm) Height 6 ½“ (160mm) Depth 14½” (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 With respect to electrical shock fire and mechanical Equipment hazards only in accordance with UL60601-1, IEC60601-1, CAN/CSA C22.2 No 601.1 and IEC60601-2-2
0473 CE mark
Attention: Consult accompanying documents
!
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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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 480 KHz (±10%) sine wave
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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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 (Optional When ordering unit) RF bursts of 20mS at a frequency of 2.0 Hz
Pulse Temp limit 42º C (option of no limit when ordering) Pulse Dose Limit 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 (optional when ordering unit)
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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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 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) Time Indicator Clock indicates the amount of time remaining for lesioning. Lesion Time Defalt is 60 Seconds
Timer/Count Time set button cycles 30, 60, 90, 120 and 240 seconds (Pulsed RF Version) default 120 Seconds Count Pulse Dose Count set cycles 120, 240, 360, and 480 counts (Pulse dose Version) default 240 Seconds Audible Indicator A one second “tick” indicates the clock is operating.
TEMPERATURE MONITOR
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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OPERATORS MANUAL
Meter Range 30ºC to 100º C Bar Display
The Bar Display has 3 colour segments 30ºC - 42ºC Amber 42ºC - 95ºC Green 95ºC - 100ºC Red Temperature set Modes 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 RF Power is automatically reduced if temperature reaches set limit as determined by Maximum Temperature Control, (either 70ºC, 80ºC or 90ºC). RF Power will automatically proceed again once the temperature of the tip of the probe drops1ºC.
Safety Interlock 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.
2.2 EARTH LEAKAGE DATA
Tests carried out as per IEC 601-1
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
NT-500 RF Lesion Generator ™
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OPERATORS MANUAL
Typical Max Allowable
1 Enclosure leakage current
Normal Reverse Single Fault condition Normal Reverse
2 Patient Leakage Current
Normal (AC) Reverse (AC) Single Fault condition Normal (AC) Reverse (AC)
3 Patient Leakage Current
Normal (DC) Reverse (DC) Single Fault Condition Normal (DC) Reverse (DC)
4 Patient Auxiliary Leakage
Normal (AC) Reverse (AC) Single Fault condition Normal (AC) Reverse (AC)
5 Patient Auxiliary Leakage
Normal (DC) Reverse (DC) Single Fault condition Normal (DC) Reverse (DC)
6 Patient Leakage Floating Type
Normal Reverse Single Fault condition Normal Reverse
40 microamps 40 microamps
40 microamps 40 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
4 microamps 4 microamps
25 microamps 25 microamps
25 microamps 25 microamps
100 microamps 40 microamps
500 microamps 500 microamps
100 microamps 100 microamps
500 microamps 500 microamps
10 microamps 10 microamps
50 microamps 50 microamps
100 microamps 100 microamps
500 microamps 500 microamps
10 microamps 10 microamps
50 microamps 50 microamps
5000 microamps 5000 microamps
5000 microamps 5000 microamps
Document Number 111/00 Operators Manual August 2007
NT-500 Lesion Generator
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