Summary of Contents for St. Jude Medical Axium
- Page 1 Axium™ Neurostimulator System Patient Programmer User Manual Model MN10600-02 Caution: Federal (USA) law restricts the use of this device by or on the order of a physician.
- Page 2 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 services marks of St. Jude Medical, LLC and its related companies.
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Page 3: Table Of Contents
Table of Contents EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING 1 INTRODUCTION ..................3 Description ....................3 Trial Neurostimulator (TNS) ..............3 Implantable Neurostimulator (INS)............3 Implant Leads / Trial Leads / Lead Extension .......... 3 Connector Cable ..................3 Additional Accessories ................ - Page 4 CONNECTING WITH YOUR STIMULATOR ..........17 Pain Control Screen ................18 ID Heading ..................... 18 Select Group ..................19 Back to Main Menu ................19 Programmer Status Bar ................. 20 ADJUSTING YOUR STIMULATOR SETTINGS ........20 Turn OFF All Stimulation ................ 20 Pain Control Tab ..................
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Page 5: Explanation Of Symbols On Product Or Package Labeling
Explanation of Symbols on Product or Package Labeling Model Number Read the Manual Serial Number Consult the Manual Accessories Programmer Manufacturing Date Manufacturer Quantity Keep Dry Contents of Package are Non-Sterile STERILE Protected against Electric Shock Not waterproof. Applies to the Programmer when it is not in its carrying case. Limited waterproof. - Page 6 Glossary Lead – Surgical wire: takes electrical signals from the neurostimulator to the stimulation area Stimulation – Small electrical pulses: produces a tingling sensation and replaces pain signals Stimulator – Device that makes electrical pulses that will stimulate the nerves in your spine: can refer to either the Trial Neurostimulator or Implantable Neurostimulator Trial Neurostimulator (TNS) –...
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Page 7: Introduction
Connector Cable or the lead and the Implantable Neurostimulator. The Lead Extension is intended for chronic implantation as a component of the Axium Neurostimulator System. Connector Cable • The Connector Cable connects the Leads or Lead Extension to the... -
Page 8: Additional Accessories
• The safety and effectiveness of this therapy has not been established for pregnancy, nursing, the unborn fetus, or delivery. • The safety and effectiveness of the Axium Neurostimulator System has not been established for pediatric use. • Do not use your Programmer until your doctor has set up your Stimulator. - Page 9 • Please contact your doctor if you experience unusual pain or discomfort during stimulation, or if the implant site is swollen, reddened, tender, or painful. • Other Active Implantable Devices - The Axium Neurostimulator system may interfere with other implanted stimulators, such as cardiac pacemakers and defibrillators which have sensing features, and may result in sensing problems or inappropriate responses.
- Page 10 ◦ You should turn your Axium Neurostimulator system device back on. ◦ Check that the Axium Neurostimulator system is working properly. ◦ Contact your doctor as soon as possible if you suspect the Axium system is not functioning properly after a CT scan.
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Page 11: Warnings Regarding The Trial Neurostimulator
• Non-Emergency Procedures – Do not have non-emergency procedures while undergoing trial stimulation. • Emergency Procedures – Designate a representative (family member or close friend) to notify any emergency medical personnel of your neurostimulator implant, if emergency care is required. You will be provided with a Medical Alert Card to carry with you to inform emergency medical personnel of your implant. - Page 12 • Scuba Diving and Hyperbaric Chambers – Avoid scuba diving and entering hyperbaric chambers above 150 kPa. These activities may damage the Axium system. • Cell Phones - While interference with cell phones is not anticipated, cell phone technology continues to change, and interaction with a neurostimulator system is possible.
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Page 13: Precautions - For Your Programmer And Your Stimulator
rare cases, as a result of the unexpected change in stimulation, patients have fallen down and been injured. Sources of potentially strong EMI include the following: ◦ Microwave transmitters ◦ Communication equipment such as microwave transmitters, linear power amplifiers, and high voltage power lines and power generators ◦... -
Page 14: Precautions - For Your Therapy
If contact has been made, wash the affected area with copious amounts of water and seek medical advice. • In case of a non-responding unit, St. Jude Medical personnel will observe the plus (+) and minus (–) marks on the battery and equipment and ensure correct use. -
Page 15: Adverse Events
The implantation of a neurostimulation system involves risk. In addition to those risks commonly associated with surgery, the following risks are also associated with implantation and use of the Axium Neurostimulator System: • Pain (where the needle has been inserted) •... - Page 16 • Clumsiness • Numbness • Temporary muscle activation • Cerebral Spinal Fluid (CSF) leakage • Tissue damage • Nerve damage • Spinal cord compression • Paralysis • Hematoma • Swelling • Seroma • Sensory loss • Skin erosion around the INS or leads •...
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Page 17: Rf Operating Frequencies
Programmer Overview Your Axium Patient Programmer is a portable, hand-held device. It is powered by an internal rechargeable battery. The Programmer can also be plugged into a power outlet for use or for recharging. Your Programmer communicates with your Stimulator to control your stimulation. -
Page 18: Programmer Features
Programmer Features With your Axium Patient Programmer, you can: • Turn stimulation ON or OFF for each body region • Adjust the stimulation level for each body region • Change the Group for stimulation - See “Select Group” under the “Pain Control Screen”... -
Page 19: Programmer Power Up
The battery can be expected to last at least 500 discharge cycles with normal use. Once it fails to hold a charge, it should be replaced by St. Jude Medical personnel only. Do not attempt to change the battery. Your Programmer and Charger can be expected to last up to two years with normal use. - Page 20 The Programmer status bar is at the bottom of the Main Menu. It displays your Programmer–Stimulator connection status, the battery charge level and the time. See the “Programmer Status Bar” section in this User Manual for more detail. Programmer Programmer Setup status bar button You can change the time and date and access the Programmer Info screen from the...
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Page 21: Stimulator Binding
Stimulator Binding Your doctor will bind and unbind your Stimulator to your Programmer. You cannot edit this information. Magnet A magnet is located under the magnet symbol on the back side of the Programmer. Place the magnet over the Stimulator to initiate connection between the Programmer and Stimulator. -
Page 22: Pain Control Screen
Pain Control Screen The ID Heading is at the top of the Pain Control Screen. The “Turn OFF All Stimulation” button is just below the ID Heading. Two tabs are below the “Turn OFF All Stimulation” button: the “Pain Control” tab and the “My Info”... -
Page 23: Select Group
Select Group The “Group” button is in the center of the Pain Control screen. Press the displayed “Group” to show a drop down menu. The drop down menu has up to four groups defined by your doctor. When you select a group name, the Stimulator switches settings to the new group. -
Page 24: Programmer Status Bar
Programmer Status Bar The Programmer Status Bar is located at the bottom of the Programmer screen. The status bar shows the Programmer-Stimulator connection status, the battery charge level and the time. • Programmer-Stimulator Connection Status: ◦ Shows “Connecting” when the Programmer is trying to connect to the Stimulator. -
Page 25: Pain Control Tab
• Press the “Turn OFF All Stimulation” button to stop all stimulation therapy. A window appears, asking you to confirm that you want to turn OFF all stimulation. NOTE: After turning OFF all stimulation, you can restore stimulation therapy for each of the body regions individually. -
Page 26: Device, Physician And Clinic Information
Stimulation Level Indicator: The stimulation level indicator is between the “-” and “+” buttons. The indicator moves up or down as you adjust the stimulation level for the selected body region. The indicator shows the current stimulation level as compared to the maximum set by your doctor. -
Page 27: Physician Information
• Implant Date: The date the INS device was implanted. This information is not for the external TNS device. Physician Information • Name: Your doctor’s name • Phone: Your doctor’s contact phone number • Email: Your doctor’s email contact Clinic Tab “Clinic”... -
Page 28: To Use With Your Tns Device
To Use with Your TNS Device To connect your Programmer to your TNS, push the “Connect” button on the Programmer. Move the Programmer magnet over the TNS in a circular motion. The Programmer will chime when connection is made. You may then use the Programmer to adjust your stimulation settings. -
Page 29: Disposal Of Your Programmer
Disposal of your Programmer Return your Programmer and your TNS to your doctor at the end of the trial period or when no longer being used. Do not discard or burn the TNS or Programmer. Fire may cause the internal batteries to explode. Do not attempt to dispose of the TNS or Programmer yourself. - Page 30 GUIDANCE AND MANUFACTURER’S DECLARATION Electromagnetic Immunity The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spinal Modulation Neurostimulator System should assure that it is used in such an environment. IEC 60601 Test Compliance Immunity Test...
- Page 31 GUIDANCE AND MANUFACTURER’S DECLARATION Electromagnetic Emissions The Spinal Modulation Neurostimulator System is intended for use in the electromagnetic environment specified below. The customer or the user of the Spinal Modulation Neurostimulator System should assure that it is used in such an environment. IEC 60601 Compliance Electromagnetic...
- Page 32 Recommended separation distances between portable and mobile RF communications equipment and the Spinal Modulation Neurostimulator System The Spinal Modulation Neurostimulator System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Spinal Modulation Neurostimulator System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the System.
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Page 33: Appendix I: Troubleshooting
Appendix I: Troubleshooting Pop Up Message Possible Solution Connection with your Stimulator was lost. • Move your Programmer over your Stimulator to Please reconnect. establish connection and reconnect to the device. • If you still have difficulty connecting, bring your Programmer closer to your Stimulator and continue to move the magnet over your Stimulator. -
Page 34: Troubleshooting Other Issues
Pop Up Message Possible Solution You have turned OFF all Stimulation. You have turned off the device by pressing the Please use your Programmer to restore switch on the TNS or by pushing the “Turn OFF All stimulation. Stimulation” button on your Programmer. •... - Page 36 Manufacturer: St. Jude Medical 6901 Preston Road Plano, Texas 75024 +1 972 309 8000 *600010294* ARTEN600010294 2017-06...
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