NT2000iX Instructions for Use Jan 2017

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies. Pat. http://patents.sjm.com © 2017 St. Jude Medical, Inc. All Rights Reserved.

Contents Indications for Use ... 1 Procedural Overview ... 1 Accessories ... 1 Warnings ... 2 Cautions ... 3 Procedural Guidance ... 4 Technical Data ... 4

Specification ... 4 Ground Leakage... 7 Environmental Conditions ... 7 Electromagnetic Compatibility ... 8 Minimizing Electromagnetic Interference ... 10 Symbols ... 10

Unpacking and Acceptance Testing ... 12 Description of the Controls ... 13 Front Panel ... 14 Connector Panel Layout... 14 Back Panel Layout ... 15

Procedure Configuration Matrix ... 15 Description of Displays ... 16 Welcome Screen ... 16 Doctor ... 17 Patient... 25 Preferences Screen ... 26 Electrode Selection... 30

Stimulation Procedures ... 31 Stimulation Design and Operation Rationale ... 31 Treatment Screen ... 32 Sensory Stimulation... 32 Motor Stimulation ... 33 Multiple Electrode Stimulation... 33 Stimulation Settings... 34

Lesion Treatment Procedures ... 34 Lesion Design and Operation Rationale ... 34 Treatment Screen ... 35 Single Lesion ... 35 Lesion Settings ... 36 Custom Mode ... 36 Multiple Lesions ... 37

Pulsed RF... 37 Pulsed RF Design and Operation Rationale... 37 Treatment Screen ... 38 Single Electrode Pulsed RF ... 39 Pulsed Settings ... 39 Multiple Electrode Pulsed RF ... 40

Pulsed Dose ... 40 Pulsed Dose Design and Operation Rationale ... 40 Treatment Screen ... 41 Single Electrode Dosed ... 41 Pulsed Dose Settings ... 42 Multiple Electrode Pulsed Dose ... 42

Dual Electrode Lesion... 42 Dual Electrode Design and Operation Rationale ... 42 Dual Electrode Operation ... 43 When To Use Dual Lesion ... 43

Simplicity II and Simplicity III... 44 Simplicity Design and Operation Rationale ... 44 Electrode Selection... 45

Cordotomy Mode ... 51 Electrode Selection... 51 Cordotomy Lesion ... 51

No Temperature Sensor Mode ... 52

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Electrode Selection ... 52 Single Electrode No Temperature Sensor ... 52 Multiple Electrode No Temperature Sensor ... 53

Documentation ... 53 Documents Screen ... 53 Saving Data to the USB Memory Stick... 53 Viewing Reports ... 54

Messages ... 54 Cleaning Procedures... 55 Cleaning Procedure for the NT2000iX™ RF Generator... 55 Cleaning Procedure for NT2000iX™ Accessories / Equipment ... 55

Testing, Electrode Connections, Lesion Sizes and Basic Procedures... 55 Using The NeuroTherm™ Stimulation Test Kit ... 55 Electrode Connections ... 57 Lesion Size Graphs ... 59 Monopolar Lesions ... 60 Lesion Size Tables ... 65

Troubleshooting ... 68 Electrode(s) Stop Working ... 68 Electrode(s) Not Getting Up To Temperature ... 68 No Stimulation To Patient ... 68 Patient Complains of Heating at the Grounding Pad ... 68

Disposal ... 68 Unit Disposal ... 69 Accessory Disposal ... 69

Maintenance ... 69 General ... 69 Basic Battery and Fuse Information ... 69 Sales, Customer Service, and Maintenance Contact Information ... 69

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Indications for Use The NT2000iX™ generator is intended for lesioning neural tissue. The NT2000iX™ generator is intended to be used for pain management. The NT2000iX™ generator is to be used only with separately cleared/approved lesion/temperature probes (NeuroTherm™ radiofrequency probes and SPINECATH™ and ACUTHERM™ catheters). The NT2000iX™ generator is indicated for use in the peripheral nervous system.

Procedural Overview Clinician Requirements: This device is only to be operated by a medical doctor trained in pain management. Diagnosis: The patient’s pain is located using various diagnostic techniques. The clinician should use the results of these tests, as well as experience and training, to determine whether radiofrequency (RF) lesions of identified neural tissue will improve the patient’s symptoms. Published guidelines are available to assist the clinician in determining when neural ablation is indicated, and in selecting the appropriate ablation technique and application. 1, 2, 3, 4, 5 Patient preparation/electrode placement: The patient is positioned on an appropriate treatment table and is prepped using standard techniques. Fluoroscopic guidance or some other type of anatomical localization technique is used to place the treatment cannula/electrode. Before the commencement of treatment, treatment settings are selected and the patient information can optionally be entered. For in depth descriptions on electrode connections, lesion sizes, and basic operation procedures refer to Testing, Electrode Connections, Lesion Sizes and Basic Procedures (page 55). Nerve localization: Sensory and motor stimulation are used to further fine tune electrode placement for many procedures. Published studies provide further guidance on these techniques. 6, 7 Both sensory and motor stimulation frequencies are available with the NT2000iX™ RF generator. Typically, low threshold responses are pursued for sensory stimulation, while high threshold responses are desired for motor stimulation. This implies proximity to the sensory nerves, while assuring distance from the motor nerves. Stimulation cannot be performed during the RF treatment process, and only one output channel can deliver stimulation pulses at any one time. 0F

5F

1F

2F

3F

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RF treatment: RF energy is delivered to the target nerves during treatment, thus causing the tissue to heat to a selected set temperature under feedback control. Energy can be delivered in Monopolar Mode using 1, 2, 3, or 4 electrodes, in Dual Mode between electrodes 1-2, 3-4, or 1-2 and 3-4, or in Simplicity Mode. Parameters such as temperature, voltage, current, and impedance are continuously displayed during energy delivery. Treatment time is selectable. RF energy can be delivered in continuous output mode, pulsed output mode, or pulsed dose output mode, depending on desired treatment. In continuous output mode, the RF is delivered in an uninterrupted fashion. In pulsed and pulsed dose modes, the RF is delivered in short bursts of energy. In general, continuous output mode is used when a thermally destructive lesion is desired and pulsed or pulsed dosed modes are used when stronger electric fields are desired with or without destructive heating. See sections 1 of Stimulation Procedures (page 31) to Simplicity II and Simplicity III (page 44), and all of Testing, Electrode Connections, Lesion Sizes and Basic Procedures (page 55) , for detailed descriptions of each of these techniques.

Accessories Table 1. NeuroTherm™ Accessories Model List Model Number

Description

AC-BI-P AC-BP-TC2 AC-CN-R AC-CN-S AC-IDET-4 AC-IDET-8 AC-NT-B AC-NT-COS AC-NT-SN

Adapter Cable-Bi Polar to NeuroTherm™ Generator Adapter Cable Adapter Cable-NT Generator to RFK Connector Adapter Cable-NT Generator to SMK Connector IDET 4 Pin Connector IDET 8 Pin Connector Adapter Cable-NT Generator to Baylis Medical 8 Reusable Electrode Adapter Cable-NT Generator to Cosman 9 Reusable Electrode Adapter Cable-NT Generator to S&N Reusable Electrode 7F

8F

Bogduk, N. Percutaneous radiofrequency lumbar medial branch neurotomy. In Practice Guidelines for Spinal Diagnostic and Treatment Procedures; Bogduk, N., Ed. International Spine Intervention Society (ISIS): San Francisco, 2004a: 188-218 2 Bogduk, N. Percutaneous radiofrequency cervical medial branch neurotomy. In Practice Guidelines for Spinal Diagnostic and Treatment Procedures; Bogduk, N., Ed. International Spine Intervention Society (ISIS): San Francisco, 2004b: 249-284. 3 Schwarzer AC, Aprill CN, Bogduk N. The sacroiliac joint in chronic low back pain. Spine 1995; 20: 31-37. 4 Fortin JD, Dwyer AP, West S, Pier J. Sacroiliac joint: Pain referral maps upon applying a new injection – arthrography technique. Part I: Asymptomatic volunteers. Spine 1994; 19:1475-1482. 5 Ferrante FM, King LF, Roche EA, Kim PS, Aranda M, et al. Radiofrequency sacroiliac joint denervation for sacroiliac syndrome. Regional Anesthesia and Pain Medicine 2001; 26 (2) 137-142. 6 Kapural L, Mekhail N. Radiofrequency ablation for chronic pain control. Curr Pain Headache Rep. 2001; 5(6): 517-525. 7 Yin W, et al Sensory stimulation guided Sacroiliac Joint Radiofrequency Neurotomy: Technique Based on Neuroanatomy of the Dorsal Sacral Plexus. Spine Vol 28, No. 20, pp 2419-2425 8 Baylis Medical is a trademark of Baylis Medical Company, Inc. 9 Cosman is a trademark of Chenes LLC. 1

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Table 1. NeuroTherm™ Accessories Model List Model Number

Description

AC-NT-TC2 AC-POLE-NT AC-SI-III DAC-NT DACUK-NT DACUK-NT-L NRFE-10 NRFE-15 NRFE-5 RF-DGP-S RFDE-10 RFDE-15 RFDE-20 RFDE-5 RFDE-SI RFDEUK-10 RFDEUK-15 RFDEUK-20 RFDEUK-5 RFE-10 RFE-10-L RFE-10-RFK RFE-15 RFE-15-D RFE-15-RFK RFE-20 RFE-5 STIM-KIT PWR-US PWR-UK PWR-AMS Various

Adapter Cable-NT Generator to TC2 Connector Adapter Cable-Pole Needle to NT Generator Adapter Cable-Simplicity III (Molded) for NT1100™ Radiofrequency Generator Adapter Cable-NT Generator to NT Disposable Electrode, US Adapter Cable-NT Generator to NT Disposable Electrode, UK Adapter Cable-NT Generator to NT Disposable Electrode, UK (Long) Nitinol RF Reusable Electrode, 10cm Nitinol RF Reusable Electrode, 15cm Nitinol RF Reusable Electrode, 5cm RF Disposable Reference Pad RF Disposable Electrode, 10cm, US RF Disposable Electrode, 15cm, US RF Disposable Electrode, 20cm, US RF Disposable Electrode, 5cm, US Simplicity III Electrode RF Disposable Electrode, 10cm, UK RF Disposable Electrode, 15cm, UK RF Disposable Electrode, 20cm, UK RF Disposable Electrode, 5cm, UK RF Reusable Electrode, 10cm RF Reusable Electrode, 10cm Long RF Reusable Electrode - RFK, 10cm RF Reusable Electrode, 15cm RF Reusable Electrode, 15mm RF Reusable Electrode-RFK, 15cm RF Reusable Electrode, 20cm RF Reusable Electrode, 5cm Stimulation Test Kit RF Generator Power Cord - USA RF Generator Power Cord - UK RF Generator Power Cord - AMSTERDAM Compatible NeuroTherm™ Radiofrequency Needles

NOTES: •

The NT2000iX™ RF generator is the only repairable device of the generator system and can only be serviced by a NeuroTherm™ company qualified technician. None of the accessories listed above are repairable.

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Do not use accessories that are not listed above or accessories from competitors, as this could compromise safety and void warranty.

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Refer to accessory Instructions for Use (IFU) for additional accessory information.

Warnings         

Read the Instructions for Use before operating the NT2000iX™ RF generator. HAZARDOUS ELECTRICAL OUTPUT – The equipment is for use only by qualified medical personnel. ELECTRIC SHOCK HAZARD – Do not under any circumstances perform any testing or maintenance on the equipment while it is being used on a patient. FIRE HAZARD – DO NOT use extension cords or adapters of any type. The power cord and plug must be intact and undamaged. ELECTRIC SHOCK HAZARD – Should the power cord or plug become cracked, frayed, broken, or otherwise damaged, it must be replaced immediately. ELECTRIC SHOCK HAZARD – Unplug the power cord before cleaning or service. ELECTRIC SHOCK HAZARD – The operator should not perform any servicing of the equipment. 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 anesthetic mixture with air or with oxygen or nitrous oxide. ELECTRIC SHOCK HAZARD – Always turn the equipment off before cleaning and do not allow any fluid to enter the ventilation holes or sockets.

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ELECTRIC SHOCK HAZARD – Do not touch any exposed wiring or conductive surface while cover is off and the equipment is energized. 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 energized equipment. ELECTRIC SHOCK HAZARD – Do not remove the top cover of the NT2000iX™ RF generator, as it will expose voltage which can cause injury or death. FIRE HAZARD – Use non-flammable agents for cleaning and disinfection wherever possible. FIRE HAZARD – Flammable agents for cleaning, disinfecting, or as solvents of adhesives shall be allowed to evaporate before application of RF surgery. POOLING HAZARD – There is a risk of pooling of flammable solutions under the patient or in body depressions such as the umbilicus, and in body cavities such as the vagina. POOLING HAZARD – Fluids pooled in the body depressions and cavities should be mopped up before the NT2000iX™ RF generator is used. IGNITION HAZARD – Attention is called to the danger of ignition of endogenous gasses (e.g., cotton and gauze saturated with oxygen may be ignited by sparks produced during normal use of the NT2000iX™ RF generator). 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. RISK OF RF BURNS TO PATIENT – Ensure patient does not come into contact with metal parts of the table and its accessories – antistatic sheeting is 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) – 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 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 grounding pad (also known as dispersive pad or reference pad) in such a way to avoid contact with the patient or other leads. RISK OF RF BURNS TO PATIENT – Place temporarily unused electrodes connected to the generator in a container or area that is electrically isolated from the patient. Never place a generator-connected electrode that is not being used in contact with the patient. RISK OF RF BURNS TO PATIENT – If unexpected readings of parameters are observed that do not correspond to the preset values, the procedure should be halted immediately by pressing the STOP button on the front panel. Do not operate the equipment again until a determination of the source of the problem has been identified and corrected. RISK OF RF BURNS TO PATIENT – If patient is sedated, place your hand on the backside of the grounding pad, while still leaving it attached to the patient, and STOP the procedure if the grounding pad gets unreasonably hot (a temperature greater than 46°C). RISK OF RF BURNS TO PATIENT – When positioning grounding pad, select a well-vascularized muscular site with proximity to the procedure. RISK OF RF BURNS TO PATIENT – Only use grounding pads listed in the Accessories (page 1). RISK OF RF BURNS TO PATIENT – Entire area of grounding pad should be reliably attached to a suitably prepared and appropriate area of the patient’s body as defined by the Grounding Pad IFU. INTERFERENCE 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 pacemaker may be damaged. In case of doubt, obtain qualified advice. INTERFERENCE WITH OTHER EQUIPMENT – During RF lesioning procedures, the radiated electrical fields may interfere with other electrical medical equipment. (See Minimizing Electromagnetic Interference (page 10).) RISK OF PATIENT INJURY – DO NOT USE ENDOSCOPICALLY- The accessories are not appropriate for endoscopic use. RISK OF RF BURNS TO PATIENT – In Manual Lesion Mode, select the lowest possible power for intended purpose. RISK OF RF BURNS TO PATIENT – Check the grounding pad before applying power to the patient. RISK OF RF BURNS TO PATIENT – If patient complains of heating at the grounding pad, stop the procedure and remove the grounding pad from patient. PROBES – Use only NeuroTherm™, SPINCATH™, or ACUTHERM™ probes or other probes cleared/approved by NeuroTherm listed in Accessories (page 1). Data log only can hold a certain number of files. Check log number before using to make sure no previous data will be over written.

Cautions CAUTION indicates a condition that may lead to equipment damage or malfunction.  Do not activate the output of the NT2000iX™ RF generator until the probe is properly positioned in the patient.  GENERAL CONSIDERATIONS – Regularly inspect the accessories of the generator. In particular, electrode cables should be checked for possible damage to the insulation.  GENERAL CONSIDERATIONS – If the equipment has in any way suffered mechanical damage, it should be returned to the supplier for inspection and test before further use.  IMPROPER LINE VOLTAGE – The voltage selector on the mains input socket is factory-set and should not be changed by the user. The serial number plate shows the correct mains input voltage for the machine and the rating of the fuses to be

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used in the mains input unit fuse holder. An incorrect voltage setting may result in generator malfunction and potential damage. USE OF FLUIDS – Ensure that, if fluids (saline etc.) are being used during a procedure, they are positioned away from the generator. DISPERSIVE CONNECTIONS – In monopolar applications, ensure that the grounding or return electrode is connected to the patient and to the Generator. CLEANING – When cleaning the outer casing touch panel or screen of the equipment; do not use abrasive agents or solvents. CONNECTION OF EQUIPMENT TO REAR OF MACHINE – Any equipment connected to the rear socket must comply with IEC 60950 and IEC 60601-1. EMERGENCY STOP – For safety, always have someone positioned next to the STOP button during operation. If at any time the device is behaving erratically, press the red STOP button, which will return the device to a safe state. An example would include if the displayed temperature and graph do not match the desired set temperature.

Procedural Guidance               

No modification of this equipment is allowed. Ensure that the electrode length and cannula length match prior to cannula placement. Always visibly inspect electrodes for kinks and wear. Be sure the electrode is fully inserted into the cannula. Failure to do so will result in potentially erroneous temperature readings. Avoid positioning the cannula in a blood vessel or with the active tip on a bone, which may act as thermal heat sinks and insulators. Use of Bipolar techniques may be desirable in order to avoid unwanted tissue damage for surgical procedures where RF current could flow through relatively small cross-sectional area of body. In Monopolar Mode, do not place multiple electrodes closer than 20 mm apart. If electrodes are to be used closer than this distance, use Dual Electrode Mode. Always ensure that, when a temperature monitoring probe is inserted into the body, it reads body temperature ± 3°C before beginning treatment. When using NeuroTherm™ accessories, please refer to the IFU for those accessories. When using SPINECATH™ or ACUTHERM™ catheters, please refer to the IFU for those devices. It is strongly recommended that motor stimulation be performed to ensure no motor nerves are in the vicinity of the active cannula tip. When positioning grounding pad, select a well-vascularized muscular site with proximity to the procedure. Do not place the grounding pad on a fatty area such as the buttocks. Immediately stop the treatment if patient complains of any warmth or heat at the pad site. The device was designed for use in a procedure room or office environment. The device is not for outdoor use.

Technical Data Specification Size Width Height Depth Weight

370 mm (14.5") 320 mm (12.6") 430 mm (17.0") 12 kg (26.4 lb)

Electrical Voltage Input Europe USA/Canada

230 Volt 110 Volt

50Hz – 60Hz 50Hz – 60Hz

Fused 1 Amp on live and neutral Fused 2 Amp on live and neutral

Power Supply and Grounding Power Consumption

150 VA

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. Poly switches are fitted into all primary and secondary windings. The enclosure and exposed parts are not connected to mains ground (class 2).

Standards This machine complies with:

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IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-1-4: 1996 (First Ed.) + Am.1: 1999 (Consolidated 1.1 Ed.) for use with IEC 60601-1 (1988), Amts 1 (1991) and 2 (1995) IEC 60601-1-6:2010 IEC 60601-1-6: 2004 IEC 60601-2-2: 2009 IEC 60601-2-2:2006 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.

Impedance Measuring Frequency Measuring Power Measurement Display Accuracy Features

460 KHz (± 3 %) Less than 200 mW 0-2000 Ω (1 Ω resolution) 50-199 Ω ± 20%; 200-799 Ω ± 10%; 800-2000 Ω ± 20% Internal 200 Ω Test Resistor Impedance in all Lesion Modes and in Stimulation Standby Mode Audible tone available in Cordotomy Stimulation Mode where frequency varies with impedance over full impedance range (50-2500 Ω). Audible tone is adjustable and mutable.

Stimulation Mode Signal Shape Output Range Voltage Stimulation Load Regulation Pulse Rates Pulse Rate Accuracy Pulse Widths Pulse Width Accuracy

Biphasic square wave with negative edge leading. This wave is available in a variety of frequencies and widths. 0-5 V ± 5% ± 5% into 50-2000 Ω Motor 2 or 5 Hz (default 2Hz) Sensory 10, 20, 50, 75, 100, 150, 180, 200 Hz (default 50 Hz) ± 3% 0.1, 0.2, 0.5, and 1.0 mS (default 1.0 mS) ± 15%

Stimulate Features     

Hardware and software lockout if voltage / current not initially set to zero. Warning on screen if stimulation control is not initially at zero. Flashing LED on front panel indicates machine is delivering stimulation pulses. Stimulation test socket is provided on front of machine to interface with the standard stimulation test kit. Various screen displays for displaying amplitude of each stimulation procedure.

Lesion Mode RF Waveform Power Output (1-4 Electrodes) Maximum Power Output Limit

Voltage Display on Screen Current Display on Screen Self Test LED Indicator Temperature Range

Timer

Special Temperature Profiles Lesion Start

460 KHz ± 3% sinusoidal Continuously variable. Maximum power output 50 W into 100 Ω. Maximum total power output (the sum of all the RF power entering the patient from all active electrodes) is hardware and software-limited to 50 W total. This power is distributed as necessary to raise the electrodes to the desired set temperature. Depending on physiological conditions, different electrodes can have different power delivered to them. The only constraint is that the total power never exceeds 50W. 0-80 RF V (RMS) ± 20% 0-625 RF mA (RMS) ± 20% 200 Ω internal load resistor built into machine LED flashes when Lesion Power is being delivered Selectable 50 – 90°C ±3˚C for Thermal Lesion (default 80°C) and selectable in 5°C steps in initial screen setups. Selectable in 1°C steps when in Lesion Mode, using ‘Temp Up’ and ‘Temp Down’ buttons. (Output is disabled if temperature is above 98°C.) Selectable 1-600 seconds (default 60 seconds) Selectable in 30-second steps in initial screen set-ups Selectable in 1-second steps when in Lesion Mode using ‘Time Up’ and ‘Time Down’ buttons One preset profile – Default – is programmed into the generator. The user can also program nine custom profiles Lesion timer starts as soon as temperature is within 5°C of desired temperature.

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Auto Mode

Display Audible Indicator

With lesion power control off, the procedure can be carried out under automatic control by pressing the ‘Auto’ button. The temperature will ramp up and time will start when the measured temperature is within 5°C of desired temperature. The lesion can be stopped at any time by pressing the touch screen "Stop" button or the red emergency "STOP" button. Temperature/Time/Voltage/Current are displayed simultaneously. An audible alarm tone will indicate the end of the procedure.

Figure 1. Power Curve 1. Output Power vs. Impedance 2. Output Power, W 3. Impedance, Ohm 4. Full Power, W

Pulsed RF Mode (1-4 electrodes) Pulsed Waveform Pulse Widths Pulse Rates Temperature Limit Time Set Voltage Range

Sinusoidal RF waves 5ms, 8ms, 20ms, 50 ms (default 20 ms) 1Hz, 2Hz, 5Hz, 10 Hz, (default 2 Hz) Selectable 42-90°C range ±3°C (default 42°C) Selectable 0 to 30 minutes (default 2 minutes) Pulsed RF can be carried out in Auto Mode at fixed voltages. Voltage range 30-75 V (default 45 V).

Custom Profile One Custom Profile and nine Programmable Profiles

Pulsed Dose Mode (1-4 electrodes) In Pulsed Dose Mode, the numbers of pulses of RF are counted until the full quantity of pulses have been delivered to the patient. Pulsed Dose Procedures are carried out in Auto Mode. Temperature Range 42-90 °C ± 3°C (Default 42°C) Pulse Counts 120-960 count (Default 240 counts) Pulse Rates 1Hz, 2Hz, 5Hz, 10Hz, (default 2Hz) Pulse Widths 5ms, 8 ms, 20 ms, 50 ms (default 20 ms) Pulsed Dose RF can be carried out in Auto Mode at fixed voltages. Voltage range 30Set Voltage Range 75 Volts (default 45 Volts). NOTE: When the electrode reaches set temperature, the RF power is switched off and the count is stopped. When the temperature is below the set temperature, the counter will start and the RF power is switched on. This will ensure only full RF pulse bursts are delivered to the patient. The procedure will end when the total selected number of pulses is reached.

Simplicity II and Simplicity III This algorithm is used with a two or three-electrode probe and can be used in radiofrequency lesion treatment to shape lesion sizes. For Simplicity II, the lesion sequence consists of a dual electrode lesion between electrodes 1 and 2, a monopolar lesion between electrode 1 and the grounding pad, and a monopolar lesion between electrode 2 and the grounding pad. There is a short time delay between the dual lesion to allow for a reduction in temperature in the lesion area. For Simplicity III, the lesion sequence consists of a dual electrode lesion between electrodes 1 and 2, a dual electrode lesion between electrodes 2 and 3, a monopolar lesion between electrode 1 and the grounding pad, a monopolar lesion between electrode 2 and the grounding pad, and lastly a monopolar lesion between electrode 3 and the grounding pad. There is a short time delay between the dual lesions to allow for a reduction in temperature in the lesion area.

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NOTE: The generator will automatically disconnect the grounding pad from the patient during the dual electrode section of this procedure.

Multiple Probes The NT2000iX™ RF generator can be operated with 1, 2, 3, or 4 probes. When in Stimulation Mode, each probe is selected by the operator for Stimulation. In RF Lesion, Pulse RF, or Pulsed Dose Mode, the generator energizes all connected probes with a control circuit to limit the total RF output to a maximum of 50 Watts. In multiple probe operation, all pulse rates are available. Features:  Hardware and Software lockout if RF Power Control not initially set to zero during Manual Mode  LED Flashes on front panel to indicate machine is delivering power  Four output sockets to accept a variety of probes  Hardware lockout if temperature exceeds 98°C  Operation of the "Stop" button sets the generator to a safe state NOTE: Independent procedure settings are not settable on individual channels.

Ground Leakage 1

2

3

4

5

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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 Current Normal (AC) Reverse (AC) Single Fault Condition Normal (AC) Reverse (AC) Patient Auxiliary Leakage Current Normal (DC) Reverse (DC) Single Fault Condition Normal (DC) Reverse (DC) Patient Leakage Floating Type Normal Reverse Single Fault Condition Normal Reverse

Typical

Maximum Allowable

40 microamps 40 microamps

100 microamps 100 microamps

40 microamps 40 microamps

500 microamps 500 microamps

5 microamps 4 microamps

100 microamps 100 microamps

7 microamps 7 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

6 microamps 6 microamps

500 microamps 500 microamps

4 microamps 4 microamps

10 microamps 10 microamps

4 microamps 4 microamps

50 microamps 50 microamps

27 microamps 27 microamps

5000 microamps 5000 microamps

36 microamps 35 microamps

5000 microamps 5000 microamps

NOTE: Leakage measurements must be made as is appropriate for Class II design. See Electrode Connections (page 57) for more information referring to how leakage measurements were attained.

Environmental Conditions 1

Transport and Storage

Temperature Humidity Pressure

-10°C to 70°C 10-95% RH 140-760 mm Hg

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Non-Condensing 0-12,200 m (0-40,000 ft)

2

Operating

Temperature Humidity Pressure

10°C to 35°C 10 to 80% RH 520-760 mm Hg

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

Electromagnetic Compatibility Electromagnetic Emissions Declaration The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment Guidance

RF emissions CISPR 11

Group 1

RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage fluctuations/ flicker emissions IEC 61000-3-3

Class A

The device uses RF energy for its internal and system interface functions. Its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded:

Class A

Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the device or shielding the location.

Complies

Electromagnetic Immunity Declaration I The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic discharge (ESD) EN61000-4-2 (IEC 1000-4-2) Electrical fast transient/burst EN61000-4-4 (IEC 1000-4-4)

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material the relative humidity should be at least 30%.

±2 kV for power supply lines

±2 kV

±1 kV for input/output lines ±1 kV differential mode

±1 kV

±2 kV common mode <5 % UT >95 % dip in UT for 0.5 cycle

±2 kV >95 % dip in VNOM for 0.5 line cycle

Surge EN61000-4-5 (IEC 1000-4-5) Voltage dips, short interruptions and voltage variations on power supply input lines. IEC 61000-4-11

40 % UT 60 % dip in UT for 5 cycles

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV

Mains power quality should be that of a typical commercial or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a 60 % dip in VNOM for battery. 5 line cycles

70 % UT 30 % dip in UT for 25 cycles

30 % dip in VNOM for 25 line cycles

<5 % UT >95 % dip in UT for 5 sec 3 A/m

>95 % of VNOM for 5 sec

Power frequency 3 A/m (50/60 Hz) magnetic field IEC 61000-4-8 NOTE: UT is the AC mains voltage prior to application of the test level. Electromagnetic Immunity Declaration II

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Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Conducted RF IEC 61000-4-6

3 Vrms 150kHz to 80MHz

3 Vrms [V1 = 3]

80 MHz to 800 MHz Radiated RF IEC 61000-4-3

3 V/m 80MHz to 2.5GHz

3 V/m [E1 = 3] 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m) Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m. Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W

0.01

Separation distance according to frequency of transmitter m 150 kHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

.117

.117

.233

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.10 .369 .369 .737 1 1.167 1.167 2.33 10 3.69 3.69 7.37 100 11.67 11.67 23.33 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacture. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Minimizing Electromagnetic Interference Although the NT2000iX™ RF generator meets the EMC requirements for a device of this type, it is good practice to follow certain guidelines to minimize the risk of interference between the generator and other devices. 1.

Do not twist the cable of the generator with those of other devices.

2.

Avoid putting the generator on top of other operating equipment or putting other operating equipment on top of the generator.

3.

The generator generates 460 KHz at up to 50 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 high-wattage 200 Ω Test Box to the machine, turn to full power in RF Lesion Mode and observe any reading changes or interference on other equipment. To minimize any interference, position the generator as far away as possible from the device with which it might interfere.

Symbols The following symbols may be found on the product or product label: Symbol

Description

Type BF equipment

Class II equipment

ETL Mark

General Warning Sign

Floating Output (Not Connected to Ground)

Follow the instructions for use

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Symbol

Description

Emergency Stop

Notified Body Mark

Consult instructions for use

Manufacturer

Manufacturing Facility

Reorder number

Serial number

Finished good

Keep dry

Caution

Prescription only

Authorized Representative in the European Community

Date of Manufacture

Lot number

11

Symbol

Description

Do not use if package is damaged

Dispose of hardware in accordance with local law

Quantity

Temperature limitations

Humidity limitation

Cable

Fuse Power Cord Kit Radiofrequency Generator Medical Electrical Equipment

Software

Unpacking and Acceptance Testing 1.

Upon receipt, the machine should be unpacked and inspected for any physical damage.

2.

Check that the voltage shown on the rear serial number plate matches the local supply. If not, contact your local distributor. Do not attempt to alter the voltage selector on the rear of the machine. This is for factory setting only.

3.

Place the NT2000iX™ RF generator 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: a.

The mains LED will light and the Red/Green LEDs for the probes will sequence showing the machine is booting up

After displaying a splash screen, the generator will then switch to its Welcome screen.

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Figure 2.

The generator is now ready for use.

Electrical Safety Testing If an Automatic or Manual Electrical Safety Analyzer 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:  Dispersive plug (4mm Safety Socket)  Four of the active Plugs (Lemo 4 pin) and 10 Pin Simplicity Connector There is no specified GROUND POINT, as the output is floating and could possibly induce operational errors. If a ground point is needed, attach onto any of the three bolts on the rear of the machine. Refer to Ground Leakage (page 7) for appropriate leakage limits.

Description of the Controls The NT2000iX™ RF generator viewed from the front is shown below. Figure 3.

In operation, control of the generator is via the touch screen. The screen will show the current settings of the machine, what is being delivered to the patient, and any error or warning messages. The touch screen is also used to set up a whole series of conditions including parameters for the treatment as well as the Doctor and Patient details. This information then forms part of the patient treatment record which can be printed out (and downloaded to a memory stick) at the end of a treatment session.

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The control of the stimulation voltage and RF power is by the two rotary controls on the front of the unit. The "Stop" button is situated close to the controls on the front panel.

Front Panel Figure 4. 1. Stimulate Control 2. RF Lesion Control 3. Stop Button

The Front Panel contains the following controls and indicators: Stimulate Control For manually setting stimulate voltage RF Lesion Control For setting RF Output in Manual Mode Stop Button For stopping a procedure in an emergency Mains ON LED To indicate all internal fuses are OK These will sequence during start up to show the computer is booting up. In the LED’s located above the input sockets procedure screens, they will: 1.

Show RED when a probe is selected but NOT detected

2.

Show GREEN when a probe is selected and detected

3.

Flash when power is being delivered.

Connector Panel Layout Figure 5. 1. Input Connectors

Dispersive Socket This 4mm socket is for the lead of a NeuroTherm™ Generator compatible dispersive grounding pad. Test Socket This 2mm socket is used to connect the test block for use in testing the thermocouple probes in the Stimulate Mode. Probe Sockets 1-4 These 6-pin sockets are used to connect electrodes for standard RF Lesion, Pulsed RF, Lesion Pulsed Dose, and Cordotomy procedures. Probe Socket 5 10-pin Socket is used for Simplicity II and Simplicity III procedures.

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Back Panel Layout Figure 6.

1.

Mains On/Off Switch This is a rocker-type switch, combined with an I.E.C. connector socket with twin ‘in-line’ anti-surge fuses in a single unit to IEC 950. This switch is used to turn the unit both On and Off. When positioning the device, make sure that the mains On/Off switch is easily accessible to the doctor and/or doctor’s assistant.

2.

Mains IEC Connector The three-pin plug of the mains must be pushed into this socket. This cannot be done incorrectly, i.e., with the live and neutral reversed, because of the orientation of the unused ground pin.

3.

Fuses and Voltage Changes The NT2000iX™ RF generator 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 2x 20mm T2AH250V for a 120V rated supply and 2x 20mm T1AH250V for a 230V rated supply. To access the fuse holder, lift the protective lid from the right hand edge and hinge back. The fuse carrier can then be removed. The mains input unit also contains a small printed circuit card which allows the mains input voltage to be changed. Note: This is for factory setting only and should not be altered. This device is not user serviceable. Maintenance should only be carried out by authorized personnel. Qualified companies and technicians can refer to the NT2000iX™ Service and Support Manual for more information.

4.

Rear Connector (Located in the black plastic plate) The Connector is a USB Memory socket available on all machines for use only with the NeuroTherm™ Memory Stick (NTUSB). DO NOT CONNECT ANY OTHER DEVICE TO THIS SOCKET.

5.

Ventilation Apertures These apertures are to ensure the correct air circulation within the generator and should not be blocked or obstructed.

Procedure Configuration Matrix Procedure Type

Number of Electrodes

Output 1

Output 2

Output 3

Output 4

Grounding Pad Connector

Monopolar procedure configurations: Current passes between each electrode and the common grounding pad. Probe 1 1 X X monopolar Probe 2 1 X X monopolar Probe 3 1 X X monopolar Probe 4 1 X X monopolar Probe 1,2 2 X X X monopolar Probe 1,3 2 X X X monopolar

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Figure Number

79 79 79 79 80 80

Procedure Type

Number of Electrodes

Output 1

Output 2

Output 3

Output 4

Grounding Pad Connector

Figure Number

Probe 1,4 2 X X X 80 monopolar Probe 2,3 2 X X X 80 monopolar Probe 2,4 2 X X X 80 monopolar Probe 3,4 2 X X X 80 monopolar Probe 1,2,3 3 X X X X 81 monopolar Probe 1,2,4 3 X X X X 81 monopolar Probe 1,3,4 3 X X X X 81 monopolar Probe 2,3,4 3 X X X X 81 monopolar Probe 1,2,3,4 4 X X X X X 82 monopolar Dual procedure configurations: Current passes between two monopolar electrodes. The generator monitors both electrode temperatures and controls the higher of the two electrode temperatures. Both temperatures are displayed on the screen. Probe 1-2 Dual* 2 X X X* 83 Probe 3-4 Dual* 2 X X X* 83 Probe 1-2, 3-4 4 X X X X X* 83 Dual* Simplicity combines both dual and monopolar to make large uniform lesions Simplicity II 2 X X X 84 Simplicity III 3 X X X X 84 * In Dual Lesion mode, a grounding pad is only needed, if doing stimulation. NOTES: •

The multi-lesion capability allows the generator to lesion tissue using multiple electrodes simultaneously. The total maximum power output is 50 W for all modes.

•

The NT2000iX™ RF generator does not allow stimulation on more than one channel at a time. Voltages for stimulation may only be applied to one electrode at a time.

•

Simplicity II and III electrode configuration is determined during set-up.

Description of Displays Welcome Screen This is the main entry screen. Upon entry, the current date, time (updated every second), and the name of the last doctor and patient selected are displayed.

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