Advanced Neuromodulation Systems St Jude Medical Neuromodulation Division 001 Low Power Transmitter User Manual 37 0426 01A

Advanced Neuromodulation Systems Inc., dba. St. Jude Medical Neuromodulation Division Low Power Transmitter 37 0426 01A

Manual

Genesis Programmer User’s GuideUSER’S GUIDENeurostimulation has been shown to benefit patients with certain types of chronic intractable pain conditions.It uses a method of pain control that replaces areas of chronic pain with a more pleasant tingling or massagingsensation called paresthesia.This manual will help you understand how to use and care for your Genesis Implantable Pulse Generator (IPG)and Programmer. Thoroughly review this manual before using your system and ask anyone involved in yourcare to also read it.If you have questions beyond those addressed in this manual, or if an unusual situation arises, consult yourphysician. Your physician is familiar with your medical history and can give you more detailed information.For assistance or questions about the system not covered in this manual call:1 (800) 727-7846 or (972) 309-8000© October 2001 by Advanced Neuromodulation Systems, Inc. All Rights Reserved.GenesisTM is a trademark and MultiStim®, PC-Stim®and Patient Controlled Stimulation®are registered trademarks of Advanced Neuromodulation Systems, Inc.CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.37-0426-01A.qxd 2/13/02 10:08 AM Page ii
Genesis Programmer User’s Guide 1CONTENTS PageIndications for Use, Contraindication, Warnings, Precautions and Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2Genesis (IPG) Neurostimulation System Clinical Summary . . . . . . . . . . . 6System Registration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Patient Accessories and Ordering Information . . . . . . . . . . . . . . . . . . . 10System Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12The Genesis Programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13The Operational Display Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Starting Your Genesis System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18To Begin Stimulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20Introduction to Program Selection* (Optional Features) . . . . . . . . . . . 21Using the Balance Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23Fine-Tuning Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Partially Authorized Programmers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Programmer Battery Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Battery Removal and Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28To End Stimulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29Using Your Magnet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Genesis System End of Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31Caring For Your Programmer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33Changes in the Stimulation Sensation . . . . . . . . . . . . . . . . . . . . . . . . . . 34Troubleshooting Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39Customer Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4437-0426-01A.qxd 2/13/02 10:08 AM Page 1
2 Genesis Programmer User’s GuideINDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS,PRECAUTIONS AND ADVERSE EFFECTSINDICATIONS FOR USEThe Genesis (IPG) Neurostimulation System is indicated as an aid in the management of chronicintractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with anyof the following: failed back surgery syndrome, and intractable low back and leg pain.CONTRAINDICATIONSThe system is contraindicated for patients with demand type cardiac pacemakers.If you are unable to operate the system or fail to receive effective pain relief during trial stimulationyou cannot be implanted with a SCS.WARNINGSThis section lists the potential hazards associated with spinal cord stimulation that you mustbe aware of to avoid serious outcomes that may cause injury or death.You should not use Spinal Cord Stimulation (SCS) if you are a poor surgical risk, have multipleillnesses or active general infections.Diathermy Therapy – You cannot have any short-wave diathermy, microwave diathermy ortherapeutic ultrasound diathermy (all now referred to as diathermy) on your body if you have anypart of a spinal cord stimulator implanted. Energy from diathermy can be transferred through theimplanted system and can cause tissue damage at the location of the implanted electrodes, resultingin severe injury or death.Diathermy is further prohibited because it may also damage the neurostimulation systemcomponents resulting in loss of therapy, requiring additional surgery for system implantation andreplacement. Injury or damage can occur during diathermy treatment whether the neurostimulationsystem is turned "On” or “Off." You are advised to inform their health care professional that youcannot be exposed to diathermy treatment.Operation of Machines, Equipment, and Vehicles — Do not drive, operate heavy machinery orpower tools with the stimulator turned on. Postural changes or abrupt movements could cause over-stimulation (jolting sensation) that might cause you to lose control of your vehicle or equipment.Magnetic Resonance Imaging (MRI) — You should NOT be subjected to an MRI. Theelectromagnetic field generated by an MRI may dislodge implanted components, damage the deviceelectronics, and induce voltage through the lead that could cause a jolting or shocking sensation.Theft Detectors and Metal Screening Devices — Certain types of antitheft devices such as thoseused at entrances/exits of department stores, libraries, and other public establishments, and/orairport security screening devices may affect stimulation. It is possible that patients who are37-0426-01A.qxd 2/13/02 10:08 AM Page 2
Genesis Programmer User’s Guide 3implanted with non-adjacent multiple leads and/or patients that are sensitive to low stimulationthresholds may experience a momentary increase in their perceived stimulation, which has beendescribed by some patients as uncomfortable or jolting. It is recommended that patients use cautionwhen approaching such a device and request assistance to bypass the device. If they must proceedthrough the device the patient should turn off the stimulator and proceed with caution, ensuring tomove through the detector quickly.Lead Movement — Avoid bending, twisting, stretching, or lifting objects over five pounds, for sixto eight weeks post-implantation. Extension of the upper torso or neck may cause lead movementand alter the stimulation field (especially with leads in the cervical area), resulting inoverstimulation or ineffective stimulation.Explosive or Flammable Gases — Do not use the programmer in an environment where explosiveor flammable gasses are present.Cardiac Pacemakers — Implanted neurostimulation systems may adversely affect the operation ofimplanted cardiac demand pacemakers.Pediatric Use — Safety and effectiveness of spinal cord stimulation has not been established forpediatric use.Pregnancy — Safety for use during pregnancy has not been established.Cardioverter Defibrillators — Neurostimulation systems may adversely affect the programmingof implanted cardioverter defibrillators.Postural Changes — Changes in posture or abrupt movements can change the level of stimulationand potentially cause unpleasant sensations. Turn your IPG off or lower the amplitude beforestretching, lifting your arms over your head, or exercising. If unpleasant sensations occur, the IPGshould be turned off.PRECAUTIONSThis section lists the actions you should be aware of and avoid to prevent situations that maycause uncomfortable sensations or damage to your neurostimulation system.Keep the Programmer Dry — Do not use the programmer when engaging in activities that mightcause the programmer to get wet, such as exposure to rain, swimming, bathing, etc. Yourprogrammer is not waterproof and should be kept dry to avoid damage.Handle the Programmer With Care — The programmer is a sensitive electronic device that canbe damaged by rough handling, including dropping on the ground or being crushed.Battery Care — Batteries can explode, leak or melt if disassembled, shorted (when batteryconnections contact metal), or exposed to high temperature or fire.37-0426-01A.qxd 2/13/02 10:08 AM Page 3
4 Genesis Programmer User’s GuideDisconnecting the Wand — Do not pull directly on the cord to disconnect the wand from theprogrammer. Doing so can damage the cord and make the wand inoperable. To disconnect thewand, grasp the connector at the contoured finger grips and pull gently downward.Medical Tests and Procedures — Before undergoing medical tests or procedures, contact yourphysician to determine if the procedure will cause you injury or damage your neurostimulationsystem. Specifically, you should be aware that medical devices such as electrohydrauliclithotriptors, therapeutic x-rays, cobalt machines, and linear accelerators may cause damage to theelectronic circuitry of an implanted neurostimulation system.Electromagnetic Interference (EMI) — Certain commercial electrical equipment (arc welders,induction furnaces, resistance welders), communication equipment (microwave programmers, linearpower amplifiers, high-power amateur transmitters), and high-voltage power lines may generatesufficient EMI to interfere with neurostimulation operation if approached too closely. Use cautionwhen approaching such devices and turn your IPG off if you feel any unusual sensations. Do notturn the IPG on again until you are away from the area of EMI interference.Control of Your Programmer — Keep your programmer out of the hands of children in order toavoid the potential of damage or unauthorized change in stimulation parameters.Physician Instructions — Always follow the programs and therapy instructions established for youby your physician. Failure to do so may cause the therapy to be less effective in providing pain relief. Unauthorized Programming Changes — Do not make unauthorized changes to physicianestablished stimulation parameters. If you find yourself in an unfamiliar screen display, press theprevious screen key.Magnet Usage — The magnet provided with your Genesis system is a high powered magnetintended for use solely with the Genesis system. Keep it away from watches, credit cards, computerdisks and other magnetic sensitive items to avoid damaging them. Always place the “Keeper Bar”on the magnet when not in use.FCC Statement — FCC ID: PX 2001 — This device (Patient Programmer) complies with part 15of the FCC Rules. Operation is subject to the following two conditions: (1) This device may notcause interference, and (2) this device must accept any interference received, including interferencethat may cause undesired operation. NOTE: Changes or modifications to this product notauthorized by ANS could void the FCC certification and negate your authority to operate thisproduct.Case Damage — If the IPG case is pierced or ruptured, severe burns could result from exposure tothe battery chemicals.Cellular Phones — The effect of cellular phones on spinal cord stimulators is unknown andpatients should avoid placing cellular phones directly over the device.37-0426-01A.qxd 2/13/02 10:08 AM Page 4
Genesis Programmer User’s Guide 5High Output Ultrasonics and Lithotripsy — The use of high output devices such as anelectrohydraulic lithotriptor may cause damage to the electronic circuitry of an implanted IPG. Iflithotripsy must be used, do not focus the energy near the IPG.Ultrasonic Scanning Equipment — The use of ultrasonic scanning equipment may cause mechanicaldamage to an implanted neurostimulation system if used directly over the implanted device.External Defibrillators — The safety of discharge of an external defibrillator on patients withimplanted neurostimulation systems has not been established.Therapeutic Radiation — Therapeutic radiation may damage the electronic circuitry of animplanted neurostimulation system, although no testing has been done and no definite informationon radiation effects is available. Sources of therapeutic radiation include therapeutic x-rays, cobaltmachines, and linear accelerators. If radiation therapy is required the area over the implanted IPGshould be shielded with lead.ADVERSE EFFECTSThe implantation of a neurostimulation system involves risk. In addition to those risks commonlyassociated with surgery, the following risks are also associated with implantation, and/or use of aneurostimulation system:●Undesirable changes in stimulation may occur over time. These changes in stimulation arepossibly related to cellular changes in tissue around the electrodes, changes in the electrodeposition, loose electrical connections and/or lead failure.●Placement of a lead in the epidural space is a surgical procedure that may expose the patientto risks of epidural hemorrhage, hematoma, infection, spinal cord compression, and/orparalysis.●Stimulation at high outputs may cause unpleasant sensations or motor disturbances(including movement). If unpleasant sensations occur, turn the IPG off immediately.●Battery failure and/or battery leakage may occur.●Radicular chest wall stimulation.●CSF leakage.●Persistent pain at the electrode or IPG site.●Seroma at the implant site.●Lead migration, which can result in changes in stimulation and subsequent reduction in painrelief.●Allergic or rejection response to implant materials.●Implant migration and/or local skin erosion.●Paralysis, weakness, clumsiness, numbness or pain below the level of implantation.37-0426-01A.qxd 2/13/02 10:08 AM Page 5

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