St. Jude Medical Axium, User Manual

Page 1: ...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 ...

Page 2: ...l 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 ...

Page 3: ...es 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 U...

Page 4: ...timulation to a Body Region 21 DEVICE PHYSICIAN AND CLINIC INFORMATION 22 My Info Tab 22 Device Tab and Physician Tab 22 Stimulator Identification 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 MANUFACTURE...

Page 5: ...rrying 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 rest...

Page 6: ...ur 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 func...

Page 7: ...s 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 tiss...

Page 8: ...iteria and agreed to rename reflex 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 ...

Page 9: ...f external defibrillator discharges on those receiving neurostimulation has not been established External defibrillation can cause induced currents in the lead extension portion of the neurostimulation system After defibrillation confirm the neurostimulation system is still working Magnetic Resonance Imaging The Axium Neurostimulator system is MR unsafe Be advised to not undergo any elective magne...

Page 10: ... output ultrasound Uses high frequency sound waves to treat bone and muscle injuries or to stimulate muscle or improve blood flow RF Ablation Uses radio frequency energy to cause controlled tissue damage Microwave Ablation Uses high speed alternating electric field to cause controlled tissue damage Dental procedures electrolysis static field therapeutic magnets and diagnostic X ray Ultrasonic Scan...

Page 11: ...ystem Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes resulting in severe injury or death Diathermy is further prohibited because it may also damage the neurostimulation system components This damage could result in loss of therapy requiring additional surgery for system removal and replacement Injury or dama...

Page 12: ... adversely affect the operation of the implanted device including areas protected by a warning notice preventing entry by patients fitted with a pacemaker 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 continue...

Page 13: ...o gently wipe the devices if needed Do not use abrasive or caustic cleaning products on your Programmer or TNS device Avoid contact with body fluids for the TNS and Programmer Contamination may cause damage to the devices Do not shower or bathe with the TNS device You may take a sponge bath You must take care not to get the TNS device wet Do not use any equipment or accessories that are not suppli...

Page 14: ...the event of a battery leak do not allow the liquid to come in contact with the skin or eyes 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 They will also wipe the battery terminals with a clean d...

Page 15: ...lectronic circuitry of an implanted neurostimulation system although no testing has been performed and no definite information on radiation effects is available Sources of therapeutic radiation include x rays cobalt machines and linear accelerators If radiation therapy is required the area over the implanted INS should be shielded with lead Long Term Effectiveness of DRG Stimulation The long term ...

Page 16: ...nts as uncomfortable stimulation jolting or shocking sensation Formation of reactive tissue in the epidural space around the lead can result in delayed spinal cord compression and paralysis requiring surgical intervention Time to onset can range from weeks to many years after implant Additional risks as a result of the placement and stimulation of the lead in the area of the DRG include pain due t...

Page 17: ...luding interference that may cause undesired operation 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 Your doctor will explain how to use the Programmer to a...

Page 18: ...our hours to fully charge the battery The Programmer Status Bar at the bottom of the screen shows the battery charge level The device is charging when the amber light is on 1 Plug the Charger into a power outlet 2 Connect the Charger to your Programmer When the battery is charging the battery icon on the screen shows AC When charging is complete the amber light becomes green Your Programmer will o...

Page 19: ... two years with normal use Programmer Power Up Press the button to turn ON your Programmer screen The Main Menu will display NOTE If your Programmer does not turn ON charge the battery and try again Main Menu The Programmer Main Menu displays two main functions Connect Allows you to connect to your Stimulator also allows you to adjust stimulation settings Programmer Setup Allows you to set your Pr...

Page 20: ...ar section in this User Manual for more detail Programmer status bar Programmer Setup button You can change the time and date and access the Programmer Info screen from the Setup screen You can also view your Stimulator serial number and your patient ID The Programmer Info screen displays your programmer serial number programmer software version firmware version and manufacturing date ...

Page 21: ...chimes when it is connected to your Stimulator Hold your Programmer steady over your Stimulator for a few seconds after the chime The Pain Control screen will then display Connected shows in the status bar at the bottom left of the screen If your Programmer cannot connect to your Stimulator 10 s an error message displays Disconnected shows in the status bar If your Programmer cannot connect to you...

Page 22: ...trol tab and the My Info Information tab See the Adjusting Your Stimulator Settings section in this User Manual for more detail The Exit button at the bottom right side of the screen returns you to the Main Menu ID Heading Located at the top of the screen the ID Heading displays the following information ID Displays your identification number ID Stimulator Serial Number Displays your Stimulator s ...

Page 23: ...p name the Stimulator switches settings to the new group NOTE When changing Groups temporary discomfort may be experienced To avoid sudden change in stimulation set Lead Enable to OFF before leaving a Group Back to Main Menu The Exit button closes the Pain Control window The session ends and returns to the Main Menu NOTE When programming is complete select the Exit button Turn off the Programmer t...

Page 24: ...ed when the Programmer is connected to the Stimulator Shows Disconnected when the Programmer is disconnected from the Stimulator Battery Level Shows the Programmer battery charge level Clock Shows the time See the Main Menu section in this User Manual for more detail Adjusting Your Stimulator Settings You can adjust your Stimulator settings from the Pain Control screen Stimulation can be turned ON...

Page 25: ... the stimulation level for each body region Turn Stimulation On or Off for a Body Region Your Programmer shows the names of one to four designated body regions that your leads affect To turn stimulation ON or OFF for a body region Select the body region by pressing the desired tab Press the OFF button to stop stimulation to that region When stimulation is OFF the OFF button is black Press the ON b...

Page 26: ...imulation level Be sure that Enable is ON when adjusting the Stimulation Level If Enable is OFF the button will not respond Device Physician and Clinic Information My Info Tab The My Info Information tab contains three tabs the Device tab the Physician tab and the Clinic tab Device Tab and Physician Tab The Device tab and Physician tab display the following information Stimulator Identification In...

Page 27: ... Physician Information Name Your doctor s name Phone Your doctor s contact phone number Email Your doctor s email contact Clinic Tab Clinic tab displays the following information Clinic Name Your clinic s name Address Your clinic s address After Hours Contact A phone number to call in case of an emergency ...

Page 28: ...n after pressing either button you must connect with your Programmer and turn the stimulation back on To Use with Your INS Device 1 2 3 4 To connect your Programmer to your INS push the Connect button on the Programmer Move the Programmer magnet over the implant location in a circular motion The Programmer will chime when connection is made You may then use the Programmer to adjust your stimulatio...

Page 29: ...tended 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 Emissions test Compliance Electromagnetic Environment Guidance RF Emissions 1 Group 2 The Spinal Modulation Neurostimulator System must emit electromagnetic energy in order to perform its intended function Ne...

Page 30: ...such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 3 V Portable and mobile RF communications equipment should be used no closer to any part of Spinal Modulation Neurostimulator System than 0 2 meter based on transmitters of 80 MHz to 2 5 GHz Interference may occur in the vicinity of equipm...

Page 31: ...or power supply lines 1 kV for input output lines Pass Mains power quality should be that of a typical commercial or home environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or home environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5...

Page 32: ...nd mobile RF communications equipment transmitters and the System Rated maximum output power of transmitter W Separation distance according to frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12m 0 12m 0 23m 0 1 0 37m 0 37m 0 74m 1 1 17m 1 17m 2 33m 10 3 70m 3 70m 7 37m 100 11 70m 11 70m 23 30m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NO...

Page 33: ...n Please contact your physician during normal business hours Contact your doctor during normal business hours to set up an appointment Your battery has reached the Elective Replacement Interval ERI Your Stimulator battery needs to be replaced Stimulation has been turned OFF permanently Please contact your physician during normal business hours Contact your doctor during normal business hours to se...

Page 34: ...tact your doctor during normal business hours All other messages Attempt to perform the actions again if possible Contact your doctor during normal business hours if the problem does not go away Troubleshooting Other Issues Condition Resolution Your Programmer is unresponsive frozen screen unable to power on etc Locate the reset pinhole on the back of your Programmer Insert a straightened paper cl...

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Page 36: ...Manufacturer St Jude Medical 6901 Preston Road Plano Texas 75024 USA 1 972 309 8000 ARTEN600010294 2017 06 600010294 ...