St. Jude Medical Axium User manual

Caution: Federal (USA) law restricts the use of this device by or
on the order of a physician.
Axium™
Neurostimulator System
Patient Programmer
User Manual
Model MN10600-02

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.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, LLC. All Rights Reserved.
Spinal Modulation is a wholly-owned subsidiary of St. Jude Medical, LLC.

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Table of Contents
EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING1
INTRODUCTION......................................................................................... 3
Description............................................................................................... 3
Trial Neurostimulator (TNS) ..................................................................... 3
Implantable Neurostimulator (INS)........................................................... 3
Implant Leads / Trial Leads / Lead Extension.......................................... 3
Connector Cable ..................................................................................... 3
Additional Accessories............................................................................. 4
Indications for Use ................................................................................... 4
Contraindications ..................................................................................... 4
Warnings and Precautions....................................................................... 4
Warnings.................................................................................................. 4
Warnings Regarding the Trial Neurostimulator ........................................ 7
Warnings - For Use in Home or Work Environments............................... 7
Precautions – For Your Programmer and Your Stimulator....................... 9
Precautions – For Your Therapy ............................................................ 10
Adverse Events...................................................................................... 11
RF Operating Frequencies..................................................................... 13
PROGRAMMER OVERVIEW.................................................................... 13
Programmer Features............................................................................ 14
Charging the Battery.............................................................................. 14
Programmer Power Up ......................................................................... 15
MAIN MENU.............................................................................................. 15
STIMULATOR BINDING............................................................................ 17
Magnet................................................................................................... 17

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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 .................................................................................... 21
Turn Stimulation On or Off for a Body Region ....................................... 21
Adjust Stimulation to a Body Region...................................................... 21
DEVICE, PHYSICIAN AND CLINIC INFORMATION................................. 22
My Info Tab ............................................................................................ 22
Device Tab and Physician Tab ............................................................... 22
Stimulator Identication Information....................................................... 22
Physician Information............................................................................. 23
Clinic Tab ............................................................................................... 23
TO USE WITH YOUR TNS DEVICE ......................................................... 24
TO USE WITH YOUR INS DEVICE .......................................................... 24
CLEANING YOUR PROGRAMMER ......................................................... 24
DISPOSAL OF YOUR PROGRAMMER.................................................... 25
ENVIRONMENTAL CONDITIONS FOR STORAGE AND OPERATION... 25
GUIDANCE AND MANUFACTURER’S DECLARATIONS ........................ 25
APPENDIX I: TROUBLESHOOTING ........................................................ 29
TROUBLESHOOTING OTHER ISSUES................................................... 30

1
Explanation of Symbols on Product or Package Labeling
Model Number Read the Manual
Serial Number
i
Consult the Manual
Accessories Programmer
Manufacturing Date Manufacturer
Quantity Keep Dry
NON
STERILE
Contents of Package are Non-Sterile
Protected against Electric Shock
I P
20
Not waterproof. Applies to the Programmer when it is not in its carrying case.
I P
22
Limited waterproof. Applies to the TNS. Applies to the Programmer in its carrying
case.
Turns the Programmer ON and OFF. Turns stimulation OFF on the TNS.
-10°C
50°C
Store between -10°C and 50°C (14°F and 122°F)
Store between 0 and 93% humidity
The device is a radio transmitter
Magnet. Shows the location of the Programmer magnet.
Do not use if package is damaged.
Caution: Federal (USA) law restricts the use of this device by or on the order of
a physician.
MR Unsafe
Electrical Safety Certication
Follow instructions for use on this website.

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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)– External Stimulator that clips onto your belt: attaches
to the connector cable, which is connected to the leads that are implanted in the area
near your spine
Implantable Neurostimulator (INS) – Stimulator implanted in your back or abdomen:
attaches to leads implanted in the area near your spine
Connector Cable – Cable that connects the leads to your Trial Neurostimulator
Programmer – Portable, hand-held device: allows you to adjust your stimulation
settings
Clinical Programmer – Portable, hand-held device: allows the physician to program
your Stimulator.
Computer Tomography (CT) Imaging – Computerized X-ray imaging: produces
electronic images of tissues and organs
Diathermy – High energy heat: used to cut or cauterize during surgery or a type of
therapy
Electromagnetic Interference (EMI) – Electrical signals that interfere with the device
function
Magnetic Resonance Imaging (MRI) – Medical imaging: produces electronic images
of tissues and organs
Paresthesia – Tingling sensation felt during therapy delivery: produced by dorsal root
ganglion stimulation
Precaution – Situation that could cause uncomfortable stimulation and possible
damage to the Stimulator or Programmer
Program – Instructions or changes to stimulation settings that are put into the
Programmer and transmitted to the Stimulator
Stimulation Level – Amount of stimulation: can be increased or decreased within a
range set up by your doctor
Warning – Potentially serious hazard that could cause injury or death

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Introduction
Your Axium™Patient Programmer is used to program your Trial or Implantable
Stimulator. This User Manual gives detailed instructions on how to safely use your
Programmer and your Stimulator. See your doctor if you have any questions.
Description
The Axium Patient Programmer is a
portable, hand-held device. It is used to
communicate with your Stimulator. Your
Programmer contains information about
your Stimulator. You will use it to adjust your
stimulation settings or turn stimulation off. It
can run on its rechargeable battery. It can
also be plugged into a power outlet.
A Clinical Programmer is used by your
doctor to initially set up your Stimulator and
make adjustments later if needed. Only
your doctor and/or St. Jude Medical clinical
personnel use the Clinical Programmer.
Trial Neurostimulator (TNS)
The external TNS device connects to the Trial Lead(s) or
Lead Extensions and is worn for up to 30 days during the trial
period. The TNS device has a belt clip for your convenience.
Implantable Neurostimulator (INS)
The Axium™Implantable Neurostimulator (INS) is a non-rechargeable,
4-channel electronic device. It uses microelectronic circuitry, powered
by a hermetically sealed battery, to generate a pulsed waveform to
stimulate neural tissue.
Implant Leads / Trial Leads / Lead Extension
• Implant / Trial Leads: The Leads are designed for implant into
your body. Leads are comprised of surgical wire which takes
electrical signals from the neurostimulator to the stimulation
area.
• Lead Extension: The Lead Extension is intended to extend the length of the
lead and provide a connection between the lead and the 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
external TNS.
LP0xxx Rev x
1
2
3
4

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Additional Accessories
• Medical Alert Card: Identies you as a user of the Neurostimulator System.
• Programmer Charger: To be used with the Patient Programmers to charge the
battery or allow use of the Programmers while plugged into standard electrical
outlets.
• Programmer Carrying Case: Protects the Programmer from water.
• Auxiliary Magnet: Allows you to turn off or communicate with the TNS or INS.
Indications for Use
The Axium Neurostimulator System is indicated for spinal column stimulation via
epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the
management of moderate to severe chronic intractable* pain of the lower limbs in
adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.**
*Study subjects from the ACCURATE clinical study had failed to achieve adequate
pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug
classes and continued their pharmacologic therapy during the clinical study.
**Please note that in 1994, a consensus group of pain medicine experts gathered by
the International Association for the Study of Pain (IASP) reviewed diagnostic criteria
and agreed to rename reex sympathetic dystrophy (RSD) and causalgia, as complex
regional pain syndrome (CRPS) types I and II, respectively.
Contraindications
Patients contraindicated for the Axium Neurostimulator System are those who:
• Are unable to operate the system
• Are poor surgical risks
Patients who fail to receive effective pain relief during trial stimulation are contraindicated
to proceed to the INS procedure.
Warnings and Precautions
• Physicians should refer to the Physician Implant Manual for a complete list of
warnings and precautions for the Axium Neurostimulator System.
Warnings
• Do not use your Programmer or the Stimulator until your doctor has trained you.
• 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.
• Before having a CT scan, tell your doctor that you have an implanted device.
All stimulation for your device should be turned OFF before the procedure.
After the scan, your doctor should turn it back on and make sure the system is
working properly.
• Do not remove your leads or Connector Cable by yourself. This may cause
serious injury and could cause an infection.

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• Do not open or modify the Programmer or TNS. Keep them closed to protect
them. Modications to the device may cause improper operation.
• Do not transport the Programmer outside of its carrying case. Operate it only in
a moisture-free environment. The Programmer may malfunction if it becomes
wet.
• Power generators, arc welders and large magnetized speakers may cause
interference. Do not stand near these or similar devices.
• Be aware of where you place your Charger. Pets, children or you can become
entangled in the cord, which could cause a fall or strangulation.
• If contact with the Stimulator System causes a rash, report this to your doctor. If
your throat or tongue starts to swell, get emergency aid immediately.
• 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
debrillators which have sensing features, and may result in sensing problems
or inappropriate responses. The effect of other implanted devices, including
deep brain stimulators, peripheral nerve stimulators, implanted drug delivery
pumps, and cochlear implants on the Axium system are unknown.
• External Debrillators – Safety for use of external debrillator discharges
on those receiving neurostimulation has not been established. External
debrillation can cause induced currents in the lead-extension portion of the
neurostimulation system. After debrillation conrm the neurostimulation system
is still working.
• Magnetic Resonance Imaging – The Axium Neurostimulator system is MR
unsafe. Be advised to not undergo any elective magnetic resonance imaging
(MRI) with the entire system, or (in the case of removal of the implanted
generator) leads or lead fragments in place. Use of MRI in the vicinity of
the lead(s) may result in forceful dislodgment of the lead(s), or damage to
the Neurostimulator. If a voltage is induced through the lead, it may cause
uncomfortable (“jolting” or “shocking”) levels of stimulation or injury. MRI may
cause heating at the lead tip and unintended stimulation could result in tissue
damage.
• Computed Tomography (CT) – Please inform your doctor and medical
personnel conducting your CT scan that you have an implanted DRG system.
You must turn your device off temporarily while the scan is being conducted. It
is important that the person conducting your CT scan does the following:
◦Determines the device type;
◦If practical, tries to move external devices out of the scan range;
◦Minimizes x-ray exposure to the implanted or externally worn electronic
medical device by:
◦Using the lowest possible x-ray tube current consistent with obtaining the
required image quality; and
◦Making sure that the x-ray beam does not dwell over the device for more
than a few seconds.

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Important note: For CT procedures that require scanning over the medical device
continuously for more than a few seconds, as with CT perfusion or interventional
exams, attending staff should be ready to take emergency measures to treat
adverse reactions if they occur.
After CT scanning directly over the implanted or externally worn electronic
medical device:
◦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.
• Tell your regular doctors or healthcare providers that you have a Stimulator.
Do not have any elective medical procedures without rst discussing them with
your doctor. Some medical devices or therapies, such as those listed below,
may interfere with your Stimulator:
◦Electrocautery – Uses an electric probe to cauterize blood vessels and stop
bleeding during surgery.
◦Lithotripsy – Uses high-output shock waves to break up gallstones and kidney
stones.
◦Therapeutic Radiation – Uses ionizing radiation to destroy cancer cells.
◦High-output ultrasound – Uses high frequency sound waves to treat bone and
muscle injuries, or to stimulate muscle or improve blood ow.
◦RF Ablation – Uses radio frequency energy to cause controlled tissue damage.
◦ Microwave Ablation – Uses high speed alternating electric eld to cause
controlled tissue damage.
◦ Dental procedures, electrolysis, static eld therapeutic magnets and diagnostic
X-ray.
• Ultrasonic Scanning – Inform your doctor and medical personnel that ultrasonic
equipment may cause mechanical damage to the lead if used directly over the
site.
• Electrosurgery Devices – Inform your doctor and medical personnel that
electrosurgery devices should not be used in close proximity to implanted lead(s).
Contact between an active lead and the electrosurgical pencil can cause direct
stimulation of the contacted nerve and can cause severe injury. Electrosurgery
devices may also damage the lead and cause a loss of stimulation.
• Implantation at Vertebral Levels above T10 – The safety and efcacy of
implantation of leads implanted above the T10 vertebral level has not been
evaluated.
• Number of Leads Implanted – The safety and efcacy of the implantation of
greater than 4 leads has not been evaluated.
• Back Pain - The safety and efcacy for the treatment of patients who have back
pain as the greatest region of pain has not been evaluated.