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Wireless Technology Information

The following table summarizes the technical details
of the Bluetooth

Smart wireless technology as it is

implemented in the device.

Table 12. Bluetooth Smart wireless technology

information

Antenna type

Embedded patch antenna in
header

Antenna dimensions

8.1 mm x 5.1 mm x 4.9 mm

Modulation

GFSK

Magnetic field strength
(at 2 m distance)

16.3 µA/m

Electric field strength
(at 2 m distance)

6.1 mV/m

Output power (EIRP*)

1 mW (0 dBm) typical, 10 mW
(+10 dBm) maximum

Range

1–2 m typical

Center frequency

2.44 GHz

Channel

40 logical channels

Bandwidth

2 MHz per channel

Data flow

Bi-directional

Protocol

Bluetooth Smart wireless
technology

*EIRP = Equivalent isotropically radiated power

Содержание St.Jude Medical Patient Controller 3875

Страница 1: ...St Jude Medical Patient Controller For Deep Brain 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: ...fects 24 Patient Expectations 28 Product Description 30 About Your System 31 Overview of the Patient Controller 33 Items You Will Receive 37 Your Personal Identification Card 38 Directions for Use 39...

Страница 4: ...Support 83 Appendix A Downloading the Patient Controller App 84 Appendix B Pairing the Patient Controller to the Generator 86 Appendix C Regulatory Statements 87 Statement of FCC Compliance 87 Statem...

Страница 5: ...and packaging NOTE For symbols and definitions for 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 contr...

Страница 6: ...R environment within the defined conditions At a minimum address the conditions of the static magnetic field the switched gradient magnetic field and the radiofrequency fields Additional conditions in...

Страница 7: ...trusion of solid foreign objects as small as 12 5 mm in diameter and is protected from vertically dripping water when the device is tilted at an angle up to 15 degrees Expiration date Date of manufact...

Страница 8: ...finitions Symbol Definition Do not use if the product sterilization barrier or its packaging is compromised Contents quantity Programmer Accessories Serial number Batch code Unique Device Identificati...

Страница 9: ...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 10: ...s 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 patient to receiv...

Страница 11: ...em is indicated for the following conditions Bilateral stimulation of the subthalamic nucleus STN or the internal globus pallidus GPi as an adjunctive therapy to reduce some of the symptoms of advance...

Страница 12: ...wave diathermy microwave diathermy or therapeutic ultrasound diathermy Electroshock therapy and transcranial magnetic stimulation TMS MRI Safety Information You may be implanted with the parts that ma...

Страница 13: ...efer to Using the MRI Mode Features page 51 in this guide Warnings The following warnings apply to these components NOTE For nontherapy related warnings regarding the St Jude Medical Patient Controlle...

Страница 14: ...ormation contact your physician Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement Stimulation at high outputs may cause unpleasant sensations or mot...

Страница 15: ...tivities feeling of hopelessness mood swings weight loss or weight gain or impulse control contact your physician If you are having thoughts of suicide contact your physician or emergency services imm...

Страница 16: ...RF or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established Induced electrical currents may cause heating especially at the lead electrode...

Страница 17: ...efibrillator or another type of neurostimulator Conversely the other active implanted device may interfere with operation of the neurostimulation system Case damage If the case of the implantable puls...

Страница 18: ...l receive an identification card to carry that will inform emergency medical personnel of your implanted system Use caution when undergoing any procedure that could include radiofrequency RF or microw...

Страница 19: ...ecautions The following precautions apply to these components NOTE For nontherapy related precautions for the St Jude Medical Patient Controller refer to the user guide available at support apple com...

Страница 20: ...blishments and airport security screening devices may affect stimulation Additionally RFID devices which are often used to read identification badges as well as some tag deactivation devices such as t...

Страница 21: ...for Parkinson s disease and VIM for essential tremor patients with an active implantable device patients requiring MRI Handling and Implantation Component manipulation Do not rub or press on implante...

Страница 22: ...try of an implanted neurostimulation system Electrical medical treatment In the case that a medical treatment is administered where an electrical current is passed through the body from an external so...

Страница 23: ...herapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system although no testing has been done and no definite information on radiation effects is available Sources...

Страница 24: ...or vehicles injure others or bring injury upon themselves Activities requiring excessive twisting or stretching Patients should avoid activities that may put undue stress on the implanted components...

Страница 25: ...tains High altitudes should not affect the neurostimulator however the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the...

Страница 26: ...ou how to control stimulation and safely use the system Magnet usage The magnet provided with the system is a high powered magnet intended for use solely with the system Keep it away from watches cred...

Страница 27: ...ugh handling such as dropping it on the ground Control of your device Keep your device out of the hands of children in order to avoid potential damage or unauthorized change in stimulation parameters...

Страница 28: ...houlder and arm postoperative pain stress or discomfort neuropathy nerve degeneration hemiparesis muscular weakness or partial paralysis on one side of body ballism or hemiballism uncontrollable movem...

Страница 29: ...tions or lead fracture Loss of therapeutic benefit as a result of change in electrode positions loose electrical connections or lead or extension fracture Initial jolt or tingling during stimulation j...

Страница 30: ...procedure to manage one of the above complications or to replace a malfunctioning component Stimulation related complications or other complications Worsening of motor impairment and Parkinson s disea...

Страница 31: ...or fatigue mania or hypomania psychosis aggression emotional lability sleep disturbance anxiety apathy drowsiness alteration of mentation postural instability and disequilibrium Restless leg syndrome...

Страница 32: ...arkinson s disease or ET who achieve these improvements deep brain stimulation may improve their quality of life and reduce the need for medications As with any surgery or therapy deep brain stimulati...

Страница 33: ...amming session the clinician will explore a range of stimulation variables to determine the optimal settings for you You will likely need to visit your deep brain stimulation team a few times to optim...

Страница 34: ...e programs that your physician has prescribed The St Jude Medical Patient Controller communicates wirelessly with the generator NOTE In this document the term patient controller refers to the St Jude...

Страница 35: ...ng the Patient Controller App page 84 The IPG connects to the implanted extensions which connect to the leads implanted in the brain The IPG delivers electrical pulses through the extensions and leads...

Страница 36: ...32 Figure 1 Interaction between major system components 1 Patient controller 2 IPG 3 Extensions 4 Leads 5 Patient magnet...

Страница 37: ...ide available at support apple com manuals for the Apple iOS device you are using to run the patient controller app The patient controller app is available from the Apple App Store and can be download...

Страница 38: ...34 Figure 2 Patient controller features 1 Power button 2 Patient controller Home button...

Страница 39: ...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 40: ...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 41: ...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 42: ...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 43: ...p automatically connects to your generator If you have multiple generators you will need to select the generator from the list NOTE If you need to pair your patient controller and generator see Append...

Страница 44: ...e following Start up screen NOTE The patient controller app times out after 3 minutes of inactivity Figure 3 Start up screen Overview of the Therapy Screen After the patient controller app connects wi...

Страница 45: ...41 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 Strength button...

Страница 46: ...ors 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 See System Information page 6...

Страница 47: ...er Displays the amount of time until therapy turns off Tap to display the Sleep Timer screen See Mode page 46 for more information Therapy button Displays whether therapy is on or off Tap to turn ther...

Страница 48: ...e Starting and Stopping Stimulation Using the Patient Controller To start or stop stimulation using the patient controller app do the following Tap the Therapy is ON or Therapy is OFF button on the Th...

Страница 49: ...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 50: ...rgy to tissue A difference in dose in this context does not imply differences in expected effectiveness response as it would with a drug There is no demonstrated difference in safety or effectiveness...

Страница 51: ...he screen to turn Airplane Ready on or off For instructions about turning Bluetooth wireless technology on see Troubleshooting page 67 For more information about Surgery Mode see Using the Surgery Mod...

Страница 52: ...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 53: ...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 54: ...e Surgery Mode to restart stimulation To disable Surgery Mode follow these steps 1 Launch the patient controller app and connect with your generator You should see the following screen showing that th...

Страница 55: ...This section provides information and instructions about what you need to do before and after an MRI scan NOTE Contact your clinician before receiving an MRI scan to find out if you can undergo the p...

Страница 56: ...receive an MRI scan follow these guidelines Charge your patient controller before the procedure Bring your identification card and patient controller to the procedure Set your IPG to MRI mode before t...

Страница 57: ...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 58: ...message appears and the MRI mode is on NOTE If a warning screen appears such as those shown in Troubleshooting Messages for MRI Modes page 78 do not proceed with the scan Disabling the MRI Mode After...

Страница 59: ...5 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 60: ...To navigate 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 progra...

Страница 61: ...57 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 62: ...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 63: ...to open the Strength screen On the Strength screen you can modify strength for the selected side Tap the or buttons to increase or decrease strength The number and green bar above the buttons will in...

Страница 64: ...60 Figure 12 Strength screen 1 Done button 2 Side 1 tab 3 Side 2 tab 4 Physician prescribed strength setting 5 Decrease button 6 Increase button...

Страница 65: ...de 1 tab Tap to view and modify strength for Side 1 Side 2 tab Tap to view and modify strength for Side 2 Physician prescribed strength setting The white notch indicates the strength setting prescribe...

Страница 66: ...g screen Figure 13 Strength screen with MultiStim programming feature System Information Tap on the Therapy screen to display the system information From these screens you can view the information for...

Страница 67: ...63 Figure 14 System information Generator screen 1 Done button 2 Manuals button 3 Generator button 4 Leads Extensions button 5 Patient Controller button...

Страница 68: ...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 69: ...ood is displayed and when the battery is approaching the end of service is displayed How long the battery lasts depends on the programmed stimulation settings how often stimulation is used and how oft...

Страница 70: ...e patient controller using only the Apple charging cord and wall outlet plug provided with your device NOTE Keep the patient controller charged or have a power supply nearby Familiarize yourself with...

Страница 71: ...care for 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 Troubleshooting This section pro...

Страница 72: ...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 73: ...Generator Battery Status page 65 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 generato...

Страница 74: ...his device was not ready to find the generator Try connecting to your generator again If you continue to encounter this problem contact Technical Support Replace Generator Soon The generator is approa...

Страница 75: ...rogram Strength was Decreased The generator could not deliver the desired strength Contact your clinician if the problem persists Try adjusting strength again If you continue to encounter this problem...

Страница 76: ...orted Device This application is not compatible with this device Use the device provided by Abbott Medical or a compatible personal Apple iOS device NOTE For more information on compatible devices see...

Страница 77: ...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 78: ...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 79: ...atient controller appears to be powered on but without display the screen may be defective Contact Technical Support Patient controller will not respond to input Patient controller has locked up Perfo...

Страница 80: ...s off or has timed out and is in standby mode Wake up the patient controller Patient controller battery is drained Charge the patient controller battery Bluetooth wireless technology connection is not...

Страница 81: ...ential issues Problem Possible Cause Possible Solution Do not operate other wireless devices at the same time Disconnect any Bluetooth wireless technology media accessories such as headphones or speak...

Страница 82: ...ller is damaged or malfunctioning Replace the patient controller Troubleshooting Messages for MRI Mode The following tables show issues you may encounter while setting MRI mode The first table shows p...

Страница 83: ...splayed instead of the MRI Mode option on the Mode screen A part of the system is not MR Conditional Contact your clinician for help identifying the models of your system If you have any implanted par...

Страница 84: ...rformed MRI is Not Advised There may be a problem with the implanted lead s Contact your clinician Your clinician can perform an additional check to see if MRI Mode can be set The generator is not in...

Страница 85: ...e cybersecurity of your patient device Protecting Access to the Patient Controller To prevent unauthorized access to your Apple device set up a passcode or other supported method of biometric security...

Страница 86: ...uthorized user from attempting to pair with the generator Guidelines for Secure Use Users should adhere to the following guidelines when using the system Do not use the application if the operating sy...

Страница 87: ...f the Patient Controller App from the App Store Install iOS software upgrades on your device as they are made available by Apple after verifying iOS software version compatibility with the Patient Con...

Страница 88: ...nt controller app is compatible with Apple iOS mobile digital devices as specified on the Abbott neuromodulation patient resources page at www NMmobiledevicesync com dbs Be sure your patient controlle...

Страница 89: ...ou will need it to verify your account and update 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 a...

Страница 90: ...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 91: ...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 92: ...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 93: ...vice has a label that contains among other information a product identifier in the following format Table 11 St Jude Medical Infinity DBS System Registration identification information Identifier Type...

Страница 94: ...antenna in header Antenna dimensions 8 1 mm x 5 1 mm x 4 9 mm Modulation GFSK Magnetic field strength at 2 m distance 16 3 A m Electric field strength at 2 m distance 6 1 mV m Output power EIRP 1 mW 0...

Страница 95: ...z Channel 40 logical channels using AFH Modulation GFSK Radiated output power 10 mW 10 dBm maximum Magnetic field strength at 2 m distance 16 3 A m Duty cycle Variable but low 5 Semi duplex capability...

Страница 96: ...service QoS should allow wireless data to be transferred at a net rate of 2 5 kB sec Each connection interval includes a semi duplex transmission with a required acknowledge a transmission latency in...

Страница 97: ...istance between the devices Move the devices so they share line of sight Move the devices away from other devices that may be causing interference Close the patient controller application and turn the...

Страница 98: ......

Страница 99: ......

Страница 100: ...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 ARTEN600090479 A 6...

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