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Table 1. Symbols and definitions

Symbol Definition

Temperature limits for storage conditions

Humidity limits

Pressure limits

Manufacturer

Do not use if the product sterilization
barrier or its packaging is compromised

Contents quantity

Programmer

Accessories

Serial number

Batch code

Unique Device Identification

Prescription use only

Содержание St. Jude Medical Patient Controller 3875

Страница 1: ...St Jude Medical Patient Controller For Spinal Cord Stimulation Systems Model 3875 User s Guide...

Страница 2: ...sician Indicates a trademark of the Abbott group of companies Indicates a third party trademark which is property of its respective owner Bluetooth and the Bluetooth logo are registered trademarks of...

Страница 3: ...20 Product Description 21 About Your System 22 Overview of the Patient Controller 24 Items You Will Receive 28 Your Personal Identification Card 29 Directions for Use 30 Start up Screen 30 Overview of...

Страница 4: ...curity Measures 77 Guidelines for Secure Use 78 Technical Support 79 Appendix A Downloading the Patient Controller App 80 Appendix B Pairing the Patient Controller to the Generator 82 Appendix C Regul...

Страница 5: ...iii Radio Transmitter Cables Transducers 88 Quality of Service for Wireless Technology 89 Appendix D Electromagnetic Compatibility Guidelines 91 Radio Frequency Information 99...

Страница 6: ......

Страница 7: ...Support Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging NOTE For symbols and definitions for the patient controller refer to the u...

Страница 8: ...evice contains a type BF applied part to protect you from shock The device is internally powered and is intended for continuous operation Magnetic Resonance MR Conditional an item with demonstrated sa...

Страница 9: ...requency RF transmitter which may cause RF interference with other devices near this device Keep dry Ingress protection rating for a device that is protected from the intrusion of solid foreign object...

Страница 10: ...ts for storage conditions Humidity limits Pressure limits Manufacturer Do not use if the product sterilization barrier or its packaging is compromised Contents quantity Programmer Accessories Serial n...

Страница 11: ...and human health which could be caused by inappropriate waste handling of this product The recycling of materials will help to conserve natural resources For more information about how to return this...

Страница 12: ...Radio Law Terms Used in This Document This section contains definitions of some of the terms used in this document Magnetic Resonance MR Conditional system A group of implanted parts that allows a pa...

Страница 13: ...stimulation programs Indications for Use This neurostimulation system is indicated as an aid in the management of chronic intractable pain of the trunk and or limbs including unilateral or bilateral...

Страница 14: ...anning under different conditions may cause device malfunction severe injury or death Contact your physician before receiving an MRI scan to find out if you can undergo the procedure and to learn more...

Страница 15: ...you have any part of a neurostimulation system implanted Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes...

Страница 16: ...system Be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system such as a pacemaker or defibrillator Electrical pulses from a neurostimulation s...

Страница 17: ...at least six weeks after implantation These activities may cause lead movement resulting in understimulation or overstimulation Excessive lead migration may require reoperation to replace the leads Em...

Страница 18: ...implanted cardioverter defibrillators Device Warnings Explosive or flammable gases Do not use the device in an environment where explosive or flammable gas fumes or vapors are present Operating the de...

Страница 19: ...the operating system in any way Strangulation The cords in this system pose a strangulation risk To avoid strangulation be careful when using cords and keep cords out of the reach of children Precaut...

Страница 20: ...n system If using a trial system and radiation therapy is required disconnect the trial generator from the leads or extensions Damage to the system may not be immediately detectable Component manipula...

Страница 21: ...devices and some medical procedures such as therapeutic radiation and electromagnetic lithotripsy Postural changes Changes in posture or abrupt movements can change the level of stimulation and poten...

Страница 22: ...ulation and proceed with caution being sure to move through the device quickly Scuba diving or hyperbaric chambers Avoid scuba diving below 30 m 100 ft of water or entering hyperbaric chambers above 4...

Страница 23: ...c lithotriptor may cause damage to the electronic circuitry of an implanted device If lithotripsy must be used do not focus the energy near the device Ultrasonic scanning equipment The use of ultrason...

Страница 24: ...ion to use it before turning it on Additional Precautions Only Applicable to the Permanent System External defibrillators Safety for use of external defibrillator discharges on a patient receiving neu...

Страница 25: ...not use the device when engaging in activities that might cause it to get wet such as swimming or bathing Handle the device with care The device is a sensitive electronic device that can be damaged b...

Страница 26: ...nges in tissue around the electrodes changes in electrode position loose electrical connections or lead failure Stimulation in unwanted places such as radicular stimulation of the chest wall Lead migr...

Страница 27: ...you to view select and control the programs that your physician has prescribed The St Jude Medical Patient Controller communicates wirelessly with the generator NOTE In this document the term patient...

Страница 28: ...OTE For more information on compatible devices see Appendix A Downloading the Patient Controller App page 80 The EPG or IPG delivers electrical pulses through the leads to electrodes near selected ner...

Страница 29: ...23 Figure 1 Interaction between major system components 1 Patient controller 2 EPG or IPG 3 Leads 4 Patient magnet...

Страница 30: ...related information on how to use the patient controller refer to the user guide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app The pa...

Страница 31: ...evice If you are using a patient controller provided by Abbott Medical refer to the following figure for the patient controller features Figure 2 Patient controller features 1 Power button 2 Patient c...

Страница 32: ...ff bar appears and then slide the bar to the right To wake the patient controller from sleep mode press the Power button To unlock the patient controller press the Home button To place the patient con...

Страница 33: ...left up or down Using a Compatible Personal Device If you are using a compatible personal Apple iOS device be sure you are familiar with how to perform these basic operational functions on your patie...

Страница 34: ...tient controller and charging cord Protective case for the patient controller Patient magnet Product documentation If you are using a compatible personal Apple iOS device you will receive the followin...

Страница 35: ...ation card does the following things Identifies you as having an implanted medical device Identifies the model numbers and locations of your implanted system parts to help determine if you can safely...

Страница 36: ...tors you will need to select the generator from the list NOTE If you need to pair your patient controller and generator see Appendix B Pairing the Patient Controller to the Generator page 82 for instr...

Страница 37: ...31 Figure 3 Start up screen Overview of the Therapy Screen After the patient controller app connects with the generator the Therapy screen appears...

Страница 38: ...32 Figure 4 Therapy screen 1 Screen title 2 Generators button 3 Information icon 4 Program name 5 Mode 6 Sleep Timer 7 Therapy button 8 Stimulation map 9 Strength button...

Страница 39: ...button to display the Generator List screen and end the session with the current generator Information icon Tap the Information icon to display the system information screen See System Information pag...

Страница 40: ...ation Sleep Timer Displays the amount of time until therapy turns off Tap to display the Sleep Timer screen See Mode page 37 for more information Therapy button Displays whether therapy is on or off T...

Страница 41: ...To start or stop stimulation using the patient controller app do one of the following Tap the Therapy is ON or Therapy is OFF button on the Therapy screen to turn stimulation on and off Adjust stimula...

Страница 42: ...e magnet Figure 5 Magnet and keeper bar 1 Magnet 2 Keeper bar 2 Hold the magnet perpendicular to and centered directly over the generator site 3 Hold the magnet in place for 2 seconds 4 Remove the mag...

Страница 43: ...programmed amount of time after which stimulation turns off and stays off until it is manually turned on trial system only The Sleep Timer which is only available with the permanent system displays th...

Страница 44: ...he screen to turn Airplane Ready on or off For instructions about turning Bluetooth wireless technology on see Troubleshooting page 63 For more information about Surgery Mode see Using the Surgery Mod...

Страница 45: ...ng steps contact Abbott Medical before your procedure Contact your clinician before your procedure to learn more about any risks Preparing for a Surgical Procedure If you are going to undergo a surgic...

Страница 46: ...Mode follow these steps 1 From the Therapy screen tap Mode to display the Mode screen 2 Tap Surgery Mode to view the Surgery Mode screen Figure 7 Surgery Mode screen 3 Tap the Surgery Mode toggle butt...

Страница 47: ...he patient controller app and connect with your generator You should see the following screen showing that the IPG is in Surgery Mode Figure 8 Generator is in Surgery Mode screen 2 Tap Exit Surgery Mo...

Страница 48: ...out if you can undergo the procedure and to learn more about any risks You have two ways to learn if the implanted parts of your system are MR Conditional Your personal identification card which your...

Страница 49: ...rive for your procedure See Setting the IPG to MRI Mode page 44 for instructions Charge your patient controller before the procedure Bring your identification card and patient controller to the proced...

Страница 50: ...tting the IPG to MRI Mode To set your IPG into MRI mode follow these steps 1 From the Therapy screen tap Mode to display the Mode screen 2 Tap MRI Mode to view the MRI Mode screen Figure 9 MRI Mode sc...

Страница 51: ...f a warning screen appears instead of the Proceed with MRI message you cannot set the IPG to MRI mode and cannot receive an MRI scan Refer to Troubleshooting page 63 for more information 5 Tap OK Disa...

Страница 52: ...6 Figure 10 MRI Mode screen 2 Tap Exit MRI Mode The patient controller app disables MRI mode The Therapy screen appears showing that stimulation therapy is off 3 To start stimulation tap Therapy is OF...

Страница 53: ...avigate between the saved programs either Swipe the screen right or left in the area containing the program information Tap the right or left arrows To select a program When you locate the program you...

Страница 54: ...48 Figure 11 Programs screen 1 Cancel button 2 Program name 3 Left arrow 4 Right arrow 5 Program indicator 6 Select This Program button...

Страница 55: ...e current Programs screen A check mark next to the program name indicates the currently selected program Left and right arrows Tap the left and right arrows to scroll through your saved programs Progr...

Страница 56: ...modify the active program strength or the strength of an individual area For instructions on modifying the strength of an Area see Adjusting Areas Strength page 54 Tap the or buttons to increase or d...

Страница 57: ...51 Figure 12 Strength screen Program tab Multiple Areas 1 Done button 2 Program tab 3 Areas tab 4 Increase button 5 Decrease button...

Страница 58: ...52 If the active program has only one programmed area you will see the following screen Figure 13 Strength screen One Area...

Страница 59: ...ram only has one Area the Program tab will not appear on the screen Areas tab Tap the Areas tab to open the Areas screen If the program only has one Area the Area tab will not appear on the screen See...

Страница 60: ...f other areas To modify the strength for an Area 1 Tap the Area you want to modify The selected Area displays with a white background and the stimulation map displays the affected area in dark blue 2...

Страница 61: ...55 Figure 14 Strength screen Areas tab 1 Done button 2 Program tab 3 Areas tab 4 Selected Area 5 Stimulation map 6 Increase button 7 Decrease button...

Страница 62: ...Area in the active program on this screen Area name Tap to select the Area you want to modify The stimulation map displays the affected area Increase button Tap to increase the strength for the select...

Страница 63: ...57 Figure 15 System information Generator screen 1 Done button 2 Manuals button 3 Generator button 4 Leads Extensions button 5 Patient Controller button...

Страница 64: ...n about how to download the MRI Procedure Information manual Generator button Tap to view information about your generator such as the generator model number Leads Extensions button Tap to view inform...

Страница 65: ...used and how often you communicate with the generator so communicate with your generator only when necessary NOTE You may also receive low battery warnings regarding the patient controller so make sur...

Страница 66: ...system contact your physician for replacement batteries if your battery indicator shows 2 or less as shown in the figure below Do not attempt to replace the batteries Figure 16 EPG battery indicator p...

Страница 67: ...e trial system Abbott Medical does not recommend charging the provided patient controller with a computer since personal information may be transferred to the patient controller which will be returned...

Страница 68: ...t Technical Support for help Caring for the Patient Controller If you are using a patient controller provided by Abbott Medical clean the protective case by wiping off the outer surface using a moist...

Страница 69: ...hat may occur NOTE If you encounter problems other than those described in this section contact Technical Support NOTE Refer to the terms and conditions for repair or replacement of Abbott Medical neu...

Страница 70: ...atient controller Home screen and tap Settings 2 Tap Bluetooth then tap the Bluetooth toggle button NOTE If you turn Bluetooth wireless technology off and on or reset the app it will take longer to re...

Страница 71: ...the Generator Battery Status then try connecting to your generator again If your generator does not have enough battery power contact your physician Generator Not Connected Connect to the generator to...

Страница 72: ...tact Technical Support Connection Not Ready This device was not ready to find the generator Try connecting to your generator again If you continue to encounter this problem contact Technical Support L...

Страница 73: ...le a replacement Contact your physician Replace Generator The generator has reached the end of its service Contact your physician to schedule a replacement Contact your physician Missing Program Infor...

Страница 74: ...herapy is OFF Therapy was turned off because the program needed to be reset Tap Dismiss Therapy is OFF You will need to select another program Tap View Programs to select another program Strength was...

Страница 75: ...blem contact your physician Increasing Strength is Not Recommended Contact your clinician to modify the program if necessary Contact your physician to modify your program Unsupported Device This appli...

Страница 76: ...patient controller Home screen to locate app Search for the app using the iOS search function Patient controller has no power or has lost power Patient controller s battery is drained Recharge the bat...

Страница 77: ...nnect the appropriate plug adapter voltage converter to the charger Charger is defective Replace the charger Patient controller is damaged or malfunctioning Replace the patient controller Nothing is d...

Страница 78: ...be defective Contact Technical Support Patient controller will not respond to input Patient controller has locked up Perform a soft reset by turning the patient controller off and back on Touchscreen...

Страница 79: ...drained Charge the patient controller battery Bluetooth wireless technology connection is not strong or turned off Decrease the distance between the devices Move the devices away from other devices t...

Страница 80: ...nect any Bluetooth wireless technology media accessories such as headphones or speakers Wait a few minutes and try connecting again Turn on Bluetooth wireless technology using the instructions in the...

Страница 81: ...RI mode Follow the guidelines to help troubleshoot the issue Table 10 Possible causes and solutions for potential issues with opening the MRI Mode screen from the Mode screen Problem Possible Cause So...

Страница 82: ...e patient controller Try connecting to the IPG again Table 11 Troubleshooting messages for MRI mode Message Description MRI is Not Advised There may be a problem with the implanted lead s Contact your...

Страница 83: ...te with important messages related to the cybersecurity of your patient device Protecting Access to the Patient Controller To prevent unauthorized access to your Apple device set up a passcode or othe...

Страница 84: ...hich includes an element of proximity A proprietary algorithm that detects and prevents an unauthorized user from attempting to pair with the generator Guidelines for Secure Use Users should adhere to...

Страница 85: ...rly check and upgrade to the latest available version of the Patient Controller App from the App Store Install iOS software upgrades on your device as they are made available by Apple after verifying...

Страница 86: ...bile digital devices as specified on the Abbott Neuromodulation patient resources page at www NMmobiledevicesync com cp Be sure your patient controller is running an Apple released iOS version before...

Страница 87: ...your app 3 Click Verify now in the e mail sent to your e mail address 4 Follow the onscreen prompts to finish creating your Apple ID To download the app 1 Make sure the device is connected to a Wi Fi...

Страница 88: ...Tap The Add Generator screen opens 4 Tap an available generator in the Select a Generator list If no generators are found you will see the No Generators Found message Tap to search for available gene...

Страница 89: ...device pursuant to part 15 of the FCC rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can...

Страница 90: ...device must accept any interference received including interference that may cause undesired operation Modifications not expressly approved by the manufacturer could void the user s authority to opera...

Страница 91: ...using equipment regulations Identification Information for Product Registration This device has a label that contains among other information a product identifier in the following format Table 12 EPG...

Страница 92: ...SPR 11 Class B This product is class B equipment which is intended primarily for use in the domestic environment Wireless Technology Information The following table summarized the technical details of...

Страница 93: ...10 m distance 0 000145 A m maximum IPG Magnetic Field Strength at 2 m distance 16 3 A m EPG Electric Field Strength 0 055 V m maximum IPG Electric Field Strength at 2 m distance 6 1 mV m Output power...

Страница 94: ...vice contains a radio transmitter receiver with the following parameters Radio transmitter parameters Frequency range 2 4000 to 2 4835 GHz Bandwidth 15 dB 2 398 to 2 4855 GHz Channel 40 logical channe...

Страница 95: ...s depending on the use environment operating room recovery room and home environment After the patient controller is paired with a generator the Bluetooth wireless technology symbol is visible on the...

Страница 96: ...n difficulty pairing devices and a need to decrease the distance between connected devices For information on how to improve connection issues please refer to Troubleshooting for Wireless and Coexiste...

Страница 97: ...ce Appendix D Electromagnetic Compatibility Guidelines The EPG hereafter the device is medical equipment and should be used with the following guidance The device requires special precautions with reg...

Страница 98: ...011 2016 and ETSI EN 300 328 V2 1 1 2016 11 However the device may cause radio interference or may disrupt the operation of nearby equipment It may be necessary to mitigate this effect by reorienting...

Страница 99: ...ts RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The device is suitable for use in all establishments including do...

Страница 100: ...V for power supply lines 1 kV for input output lines Not applicable No guidance for battery powered devices Surge IEC 61000 4 5 1 kV line to line 2 kV line to ground Not applicable No guidance for bat...

Страница 101: ...t in which radiated RF disturbances are controlled The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF...

Страница 102: ...r higher immunity test levels where P is the maximum power in watts W d is the recommended separation distance in meters m and E is the immunity test level in volts per meter V m NOTE UT is the AC mai...

Страница 103: ...0 4 3 385 MHz 27 V m 18 Hz pulse modulation 27 V m Recommended minimum separation distance d 0 3 m 450 MHz 28 V m FM modulation 28 V m 710 MHz 745 MHz 780 MHz 9 V m 217 Hz pulse modulation 9 V m 810 M...

Страница 104: ...nment Guidance 5240 MHz 5500 MHz 5785 MHz 9 V m 217 Hz pulse modulation 9 V m WARNING Do not use portable RF communications equipment including peripherals such as antenna cables and external antennas...

Страница 105: ...1 and ETSI EN 301 489 17 NOTE Maintain a reasonable distance between other electronic equipment and the device CAUTION The ISM band used by this device has been approved by the Federal Communications...

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Страница 108: ...edical 6901 Preston Road Plano Texas 75024 USA 1 855 478 5833 1 651 756 5833 Abbott Medical The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium 32 2 774 68 11 2020 04 ARTEN600090481 A 6...

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