NT2000iX Quick Start Guide May 2018

POWERING ON

1. Insert the power cord into the power cord connector on the generator’s rear panel. 2. Plug the other end of the power cord into a hospitalgrade AC outlet. 3. Flip the power switch located on the rear panel to turn the generator on. 4. The system will run a self-test and then display the Welcome screen shown above.

NOTE: In this guide, we use green boxes to indicate where you will tap the touchscreen to complete the steps. They do not appear on the display screen itself.

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

DOCTOR AND PATIENT PROFILES

1. From the Welcome screen, tap Doctor.

2. The Doctor Profile screen appears. • To change the settings for an existing profile, tap the doctor’s name. Then tap Edit. • To create a new profile, tap a blank field. • To select an existing profile to perform a procedure with, go to Step 4.

3. Tap in each field to either edit or enter new information. When everything is complete and accurate, tap Save.

4. Tap the doctor profile you would like to use. If desired, change treatment settings for that doctor profile on the left. Then tap Save to return to the Welcome screen.

NOTE: To edit or add a new patient profile, tap Patient from the Welcome screen. Then follow the same procedure as above.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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EDITING TREATMENT SETTINGS FROM THE WELCOME SCREEN 1. Tap Doctor.

2. On the left, tap the treatment mode you want to edit. The settings for that treatment then appear on the right. To select a different treatment mode to edit, first tap Save or Cancel.

FROM THE LESION PROCEDURE SCREEN 1. Tap the treatment settings button in the lower left corner to change the settings for the current procedure only.

DEFAULT SETTINGS

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Thermal Lesion RF default: 80 °C for 60 seconds

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Pulsed RF default: 42 °C for 2 minutes with a pulse width of 20 ms and a frequency of 2 Hz

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The Default doctor profile settings cannot be edited. To edit preferences, a new profile must be created.

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

DOCUMENTS AND PREFERENCES

On the Welcome screen, tap Documents to view, delete, print or copy document files to a USB.

On the Welcome screen, tap Preferences to access the Site Labels, Date and Time, Self Test, Service and Advanced preferences screens.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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GETTING STARTED

1. On the Welcome screen, tap Start.

2. The Electrode Configuration screen appears. Set the electrode configuration for the procedure and then tap Continue.

3. The Electrode Warning message appears whether or not electrodes are connected. Check to ensure the electrodes are connected properly, and then tap anywhere on the screen to continue.

4. The Choose Treatment screen appears. Select the desired treatment and then tap Continue.

NOTE: Confirm that the electrodes and grounding pad are properly connected to the appropriate ports.

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

STIMULATION AND TREATMENT IF YOU SELECTED SENSORY OR MOTOR ON THE CHOOSE TREATMENT SCREEN:

3. T urn the Stim Output knob back to its starting position and repeat for any additional sites.

1. Turn the Stim Output knob located on the left side of the generator clockwise to increase voltage. 2. Tap Log to record the value in the procedure record. The bar value will remain on the screen.

IF YOU SELECTED LESION ON THE CHOOSE TREATMENT SCREEN: 1. Tap Lesion, Pulsed or Dosed at the top of the screen to choose your treatment mode.

2. For Lesion and Pulsed modes, tap Manual or Auto to start the procedure. • For a manual procedure, use the RF Output knob located on the right side of the generator.

3. For Dosed mode, tap Auto to start the procedure. 4. To stop before the procedure is complete, tap Stop on the screen* at any time.

*NOTE: Pressing the red “Emergency Stop” button on the generator’s front panel will require a reboot of the machine.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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SIMPLICITY™ PROBE

1. To use the Simplicity™ III procedure, choose the desired setting on the Electrode Configuration screen.

2. Tap Auto to start treatment.

3. To stop before the procedure is complete, tap Stop on the screen* at any time. For a full explanation of the Simplicity™ probe procedure, refer to the Simplicity Radiofrequency (RF) Denervation Probe Technique Guide

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

CUSTOM SETTINGS

1. Tap the treatment settings button in the lower left corner of the Lesion Procedure screen.

2. Tap Custom.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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SITE LABELS

1. From the Lesion Procedure screen, tap the Site # you would like to name.

2. On the Site Labels screen, you can customize the target nerve name according to the location of the probe. Custom names can be created by tapping Custom name. Tap Save to record your changes.

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

FREQUENTLY ASKED QUESTIONS Q: DO I NEED TO USE A GROUNDING PAD WHEN LESIONING IN DUAL-ELECTRODE MODE? A: A grounding pad is still required for the initial Sensory and Motor stimulation, but not when creating the dual lesion. When creating a lesion using the Dual-Electrode setting, one of the electrodes is the set temperature electrode (controlling electrode) while the other electrode is passive and serves to complete the circuit.

Q: WHILE LESIONING IN DUAL-ELECTRODE MODE AT A SET TEMPERATURE OF 90 °C, SOME CHANNELS DO NOT REACH THE SET TEMPERATURE. WHY? EXAMPLE (TWO DUAL LESIONS): PORT 1 IS AT 85 °C, PORT 2 IS AT 90 °C. PORT 3 IS AT 75 °C AND PORT 4 IS AT 90 °C. A: One electrode can be warmer than the other. The NT2000iX™ RF generator will automatically select the electrode with the higher temperature to be the controlling, or active electrode. The active electrode will achieve set temp while the passive electrode will often be lower than set temp due to factors such as proximity to bone, blood vessels or other fluid (e.g., lidocaine).

Q: WHAT IS THE DIFFERENCE BETWEEN BIPOLAR AND DUAL-ELECTRODE ON ABBOTT RF UNITS? A: Duel-electrode refers to two electrodes and two needles. Bipolar refers to a special needle with two electrodes on the shaft.

Q: WHEN PERFORMING SENSORY AND MOTOR STIMULATION USING ABBOTT RF NEEDLES, IS THE CURRENT CARRIED BY THE ENTIRE ACTIVE TIP (E.G., 10 MM) OR JUST THE VERY TIP OF THE NEEDLE? A: The entire active tip.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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TROUBLESHOOTING NO TEMPERATURE READING ON THE THERMOCOUPLE ELECTRODE •

Check the electrode for any visual defects.

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Plug the electrode into the NT2000iX™ RF generator and set the machine to Lesion mode. Ensure the Probe 1 LED changes from red to green on the front panel of the generator. If it stays red, the thermocouple may be damaged. Replace the electrode.

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Place the electrode tip into 50 °C water to see if the temperature display changes to the water temperature. If it does not, the thermocouple may be damaged.

NO STIMULATION FELT BY PATIENT •

Is the grounding pad affixed to the patient correctly? (Refer to the grounding pad “Instructions for Use” for proper placement.)

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Is the grounding pad the correct size (16 square inches of surface area)?

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Is the grounding pad cable connected to the NT2000iX RF generator?

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Is the electrode connected to the correct input socket as shown by the Probe LED?

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Is the electrode the correct length for the needle, for example, 10 cm electrode with a 10 cm needle?

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Are thermocouple electrodes and RF needles being used?

WILL NOT REACH TEMPERATURE •

Is the grounding pad affixed to the patient correctly?

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Is the grounding pad cable connected to the NT2000iX RF generator?

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Is the electrode the correct length for the needle, for example, 10 cm electrode with a 10 cm needle?

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Is the needle placed close to a blood vessel? High blood flow may cool the needle.

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Is the average impedance reading of the patient normal (200 to 800 ohms)? If not, try to reduce the impedance by repositioning the needle/electrode.

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

CAUTIONS •

When positioning the grounding pad, select a well-vascularized muscular site within proximity to the procedure.

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Failure to achieve good skin contact by the entire surface of the grounding pad may result in significant electrosurgical burns at the pad location. Check the pad contact thoroughly before treatment. Stop treatment immediately and check grounding pad contact if the measured impedance is > 800 ohms or any significant impedance increases (> 100 ohms) are observed during RF delivery.

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Only use grounding pad listed in the Recognized Accessory List (Section 1.3 of the NT2000iX™ RF generator Operator’s Manual).

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Always alert the patient to inform personnel if any heating sensation is felt at the grounding pad site during RF treatment. If sedating the patient, monitor the grounding pad temperature throughout the treatment. Suspend treatment and check grounding pad contact if heating during RF treatment is felt.

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Check the dispersive port and the grounding pad before applying power to the patient.

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Do not cut or modify the grounding pad in any way.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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ERROR MESSAGES ERROR MESSAGE

DESCRIPTION

CORRECTIVE ACTION

Probe X over 98 °C, press back*

The temperature exceeded 98 °C on one or more of the electrodes. As a safety measure, the generator discontinued power to the electrodes disconnecting the patient from the machine.

Tap Back and then re-enter the lesion screen and attempt to continue the procedure. If the problem persists, please contact your local Sales Representative.

No thermocouple on probe X*

The temperature reading device similar to a thermostat in the electrode is potentially damaged or has failed due to wear.

Disconnect the electrode and reconnect. If the problem persists, exchange the electrode and contact your local Sales Representative.

Check connector and probe

The generator detects a connector but does not recognize a completed circuit.

Disconnect the electrode(s) and reconnect. If the problem persists, exchange the electrode(s) and contact your local Sales Representative.

An error has occurred

The generator was unable to complete the procedure and disconnected power to the patient as a safety precaution.

Disconnect all of the electrodes, restart the machine using the power switch and attempt to complete the procedure. If the problem persists, please contact your local Sales Representative.

Emergency stop has been pressed

The red “Emergency Stop” button on the front panel was pressed, disconnecting power to the electrodes.

Disconnect all of the electrodes, restart the machine using the power switch and attempt to complete the procedure. If the problem persists, please contact your local Sales Representative.

Fuse blown

An inline fuse in the machine was blown during the procedure.

Please contact your local Sales Representative.

Invalid MAC address

The printer’s MAC address is invalid or not set.

Ensure that the MAC address of your printer is entered correctly in the Printer Set Up screen of your generator. Check your printer to ensure it is working correctly and try again.

Amplifier fault

A hardware component has potentially failed.

Please contact your local Sales Representative.

USB stick not connected

The generator does not recognize the USB storage device plugged into the port on the back of the machine.

Remove the storage device, reinsert it and reattempt the file download. If the download does not work, the storage device may need to be formatted. Using a Windows‡ based computer, complete a full format of the storage device. When complete, reattempt the file download. If the problem persists, please contact your local Sales Representative.

*“X” indicates the electrode number(s) stated on the generator error message

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This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

This document is a guide. For complete details, always refer to the NT2000iX™ RF Generator Operator’s Manual.

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1. Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99–11 2. Cigna Medical Coverage Policy. Minimally Invasive Treatment of Back and Neck Pain. July 15, 2014. 3. Humana Medical Coverage Policy. Neuroablative Techniques for Chronic Spinal Pain. October 23, 2014. 4. Cohen, S. (2005). Sacroiliac joint pain: a comprehensive review of anatomy, diagnosis, and treatment. Anesthesia and Analgesia, 101, 1440-1453. 5. Yin, W., Willard, F., Carreiro, J., & Dreyfuss, P. (2003). Sensory stimulation-guided sacroiliac joint radiofrequency neurotomy: technique based on neuroanatomy of the dorsal sacral plexus. Spine, 28, 2419-2425.

Abbott One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 SJM.com St. Jude Medical is now Abbott. Product referenced is CE marked. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third party trademark, which is property of its respective owner. © 2018 Abbott. All Rights Reserved. 26928-SJM-NET-0815-0023(1) | Item approved for international use only.