St. Jude Medical 3875 User Manual

Patient controller for deep brain stimulation systems

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St. Jude Medical™ Patient

Controller

For Deep Brain Stimulation Systems

Model 3875

User's Guide

Table of Contents

Summary of Contents for St. Jude Medical 3875

Page 1 St. Jude Medical™ Patient Controller For Deep Brain Stimulation Systems Model 3875 User's Guide...
Page 2 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 service marks of St. Jude Medical, LLC and its related companies.
Page 3: Table Of Contents
Contents About This Guide ............1 Symbols and Definitions ........1 Terms Used in This Document ......6 Prescription and Safety Information ......6 Intended Use ............6 Indications for Use ..........7 Contraindications ..........7 Warnings ............. 8 Precautions ............14 Adverse Effects ..........
Page 4 Checking the Patient Controller Battery Status ... 55 Caring for the Patient Controller ......55 Protecting Access to the Patient Controller ..56 Troubleshooting ............56 Technical Support ..........68 Appendix A: Downloading the Patient Controller App ..............68 Appendix B: Pairing the Patient Controller to the Generator.............
Page 5: About This Guide
About This Guide This guide explains how to use the St. Jude Medical™ Patient Controller application (Model 3875) with your neurostimulation system. If you have any questions about your system, contact Technical Support. Symbols and Definitions The following symbols may be used in this document...
Page 6 Table 1. Symbols and definitions Symbol Definition Consult this document for important safety-related information (This symbol is blue and white on the device.) Consult instructions for use Device contains a type BF applied part to protect you from shock. The device is internally powered and is intended for continuous operation.
Page 7 Table 1. Symbols and definitions Symbol Definition Manufacturing facility Manufacturer Do not use if the product sterilization barrier or its packaging is compromised Contents quantity Batch code Prescription use only...
Page 8 Definition This product shall not be treated as household waste. Instead it is the user’s responsibility to return this product to St. Jude Medical for reprocessing. By ensuring that this product is disposed of properly, you will help prevent potential negative...
Page 9 Table 1. Symbols and definitions Symbol Definition European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, St. Jude Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive. Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum...
Page 10: Terms Used In This Document
The St. Jude Medical™ neurostimulation system is designed to deliver electrical stimulation to targets in the brain. The St. Jude Medical™ Patient Controller app is intended to be used as part of the system to help the patient manage prescribed stimulation...
Page 11: Indications For Use
Indications for Use The St. Jude Medical™ deep brain stimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus  (STN) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinson’s disease that are not adequately controlled by medications.
Page 12: Warnings
(TMS) Warnings The following warnings apply to this neurostimulation system. NOTE: For non-therapy related warnings regarding the St. Jude Medical™ Patient Controller, refer to the Apple™ manual available at http://www.apple.com/support/ipodtouch/. System Warnings Pregnancy and nursing. Do not use the neurostimulation system if you are pregnant or nursing.
Page 13 and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. If the programming of stimulation parameters exceeds the charge density limit of 30 μC/cm2, a screen will appear warning you that the charge density is too high.
Page 14 Device components. The use of components not approved for use by St. Jude Medical may result in damage to the system and increased risk to the patient.
Page 15 Implanted cardiac devices. Physicians need to 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 system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately.
Page 16 Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to St. Jude Medical. Low frequencies. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency).
Page 17 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 device could cause it to ignite, causing severe burns, injury, or death. Interference with other devices. This equipment can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices.
Page 18: Precautions
Precautions The following precautions apply to this neurostimulation system. NOTE: For nontherapy related precautions for the St. Jude Medical™ Patient Controller, refer to the Apple™ manual available at http://www.apple.com/support/ipodtouch/. General Precautions Infection. Follow proper infection control procedures. Infections may require that the device be explanted.
Page 19 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 those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Use caution when approaching such a device and request help to bypass the device.
Page 20 Handling and Implantation Component manipulation. Do not rub or press on implanted components through the skin. This may cause the leads to move leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection.
Page 21 electrodes to off, turning stimulation off, and setting the stimulation strength to zero. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. High-output ultrasonics and lithotripsy. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted device.
Page 22 area over the implanted IPG should be shielded with lead. Damage to the system may not be immediately detectable. Electrocardiograms. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results.
Page 23 may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Component manipulation by patient. Patients should avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site).
Page 24 parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Mobile phones. The effect of mobile phones on deep brain stimulation is unknown. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components.
Page 25 Patient training. Do not use your neurostimulation system until an authorized clinician has trained you 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.
Page 26: Adverse Effects
Device modification. This equipment is not serviceable by the customer. To prevent injury or damage to the system, do not modify the equipment. If needed, return the equipment to St. Jude Medical for service. Adverse Effects Deep brain stimulation potentially has the following adverse effects: Possible surgical complications.
Page 27 (nerves to chest, shoulder 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 movements on both or only one side of the body); confusion—transient, nocturnal or ongoing;...
Page 28 Initial jolt or tingling during stimulation; jolting or shocking sensations Infection Paresthesia Lead fracture, migration, or dislodgement Misplaced lead Extension malfunction, fracture, or disconnect Deep brain stimulation system failure or battery failure within the device Deep brain stimulation system malfunction or dislodgement Spontaneous turning on or off of the IPG Allergic or rejection response to implanted...
Page 29 Stimulation-related complications or other complications Worsening of motor impairment and Parkinson’s disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia Paresis, asthenia, hemiplegia, or hemiparesis Dystonia Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance...
Page 30 Supranuclear gaze palsy Hypersexuality or increased libido Decreased therapeutic response Urinary incontinence or retention Diarrhea or constipation Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope) Difficulty breathing Increased salivation Weight gain or loss Eye disorder including eye apraxia or blepharospasm Nausea or vomiting Sweating...
Page 31: Patient Expectations
Patient Expectations You and your doctor should discuss the benefits and risks of deep brain stimulation. The primary goal of deep brain stimulation for Parkinson's disease is to increase the amount of time that you are not bothered by dyskinesias, i.e. involuntary movements. The primary goal of deep brain stimulation for essential tremor (ET) is to reduce your tremor.
Page 32 about the risks associated with placement and use of a deep brain stimulation system. Your deep brain stimulation team will work with you to adjust programming and medication (if appropriate) to find the best possible combination for your symptoms and lifestyle. Programming will be done using a device that can “talk”...
Page 33: Product Description
Product Description The St. Jude Medical™ Patient Controller application (Model 3875) allows 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: Do not install additional applications on the St.
Page 34: About Your System
About Your System This neurostimulation system is designed to deliver electrical stimulation to targets in the brain. The neurostimulation system includes the following primary components: Implantable pulse generator (IPG)  Extensions  Leads  Patient controller  Patient magnet  The IPG connects to the implanted extensions, which connect to the leads implanted in the brain.
Page 35: Overview Of The Patient Controller
Interaction between major system Figure 1. components 1. Patient controller 2. IPG 3. Extensions 4. Leads 5. Patient magnet Overview of the Patient Controller Refer to the following figure for the patient controller features. NOTE: For nontherapy related information on how to use the patient controller, refer to the Apple™...
Page 36 Patient controller features Figure 2. 1. Power button 2. Patient controller Home button...
Page 37 Table 2. Patient controller feature descriptions Power button To turn the patient controller on, press and hold the Power button until the Apple™ icon appears. To turn the patient controller off, press and hold the Power button until the slide to power off bar appears, and then slide the bar to the right.
Page 38: Items You Will Receive
Table 2. Patient controller feature descriptions Touch screen To swipe the screen to the right, swipe touch the left side of the screen functionality and briefly drag your finger to the right side, and then lift your finger from the screen. Use the same general steps to swipe the screen left, up, or down.
Page 39: Directions For Use
Provides information that allows your physician to  be contacted in an emergency If you have questions about your card, contact Technical Support. Directions for Use Read this section for instructions on how to use the patient controller app. If you do not have the app downloaded, see "Appendix A: Downloading the Patient Controller App"...
Page 40: Overview Of The Therapy Screen
Start-up screen Figure 3. Overview of the Therapy Screen After the patient controller app connects with the generator, the Therapy screen appears.
Page 41 Therapy screen Figure 4. 1. Screen title 2. Generators button 3. Information icon 4. Program name 5. Mode 6. Sleep Timer 7. Therapy button 8. Strength button...
Page 42 Table 3. Therapy screen descriptions Screen Section Description or Button Name Screen title Displays the name of the screen you are viewing. Generators Tap the Generators button to button display the Generator List screen and end the session with the current generator.
Page 43 Table 3. Therapy screen descriptions Screen Section Description or Button Name Mode Displays the active program mode (Continuous or Cycle). Tap to display the Mode screen and enable Airplane Ready mode or Surgery Mode. See "Program Mode" (page 42) for more information.
Page 44: Starting And Stopping Stimulation
Table 3. Therapy screen descriptions Screen Section Description or Button Name Strength button Displays the active program stimulation strength level. Tap to display the Strength screen. You will not see this button if your physician has not programmed you to modify your program strength. See "Adjusting Program Strength"...
Page 45 To start or stop stimulation using the magnet, follow these steps: 1. Take the keeper bar off the magnet. Magnet and keeper bar Figure 5. 1. Magnet 2. Keeper bar 2. Hold the magnet perpendicular to and centered directly over the generator site. 3.
Page 46: Program Mode
Program Mode Depending on the programmed mode, Continuous or Cycle is displayed on the Therapy screen. Continuous – provides nonstop stimulation  Cycle – automatically alternates between on and  off for the preset stimulation periods in the selected Program; displays the remaining time in the current Cycle –...
Page 47: Using The Surgery Mode Feature
Using this feature turns therapy off while you undergo your procedure. NOTE: If you feel uncomfortable completing the following steps, contact St. Jude Medical before your procedure. Contact your clinician before your procedure to learn more about any risks.
Page 48 Preparing for a Surgical Procedure If you are going to undergo a surgical procedure, follow these guidelines: Set your IPG to Surgery Mode before your  procedure. See "Setting the IPG to Surgery Mode" (page 44) for instructions. Charge your patient controller before the ...
Page 49 Surgery Mode screen Figure 7. 3. Tap the Surgery Mode toggle button. Stimulation stops and you may undergo your surgical procedure. Disabling the Surgery Mode After your procedure, you need to disable Surgery Mode to restart stimulation. To disable Surgery Mode, follow these steps: 1.
Page 50 Generator is in Surgery Mode screen Figure 8. 2. Tap Exit Surgery Mode. The patient controller app disables Surgery mode. The Therapy screen appears, showing that stimulation therapy is off. 3. To start stimulation, tap Therapy is OFF.
Page 51: Viewing And Selecting A Program
Viewing and Selecting a Program Tap the program name on the Therapy screen to open the Programs screen. On the Programs screen you can view and select any of the saved programs. To navigate between the saved programs, either: Swipe the screen right or left in the area ...
Page 52 Programs screen Figure 9. 1. Cancel button 2. Program name 3. Left arrow 4. Right arrow 5. Program indicator 6. Select This Program button...
Page 53 Table 4. Programs screen descriptions Screen Section Description or Button Name Cancel button Tap Cancel to return to the Therapy screen. No program changes will be made. Program name Displays the program name of the current Programs screen. A check mark next to the program name indicates the currently selected program.
Page 54: Adjusting Strength
Adjusting Strength Tap Strength on the Therapy screen 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 increase or decrease as you increase or decrease strength.
Page 55 Strength screen Figure 10. 1. Done button 2. Decrease button 3. Increase button...
Page 56: System Information
Table 5. Strength screen descriptions Screen Section Description or Button Name Done button Tap Done to save changes and return to the Therapy screen. Increase button Tap to increase the strength for the selected side. Decrease button Tap to decrease the strength for the selected side.
Page 57 System screen Figure 11.
Page 58: Maintaining The Generator And Patient Controller
Maintaining the Generator and Patient Controller This section provides tips and other information about maintaining your generator and patient controller. Checking the Generator Battery Status As the battery is used, the generator battery indicator on the System screen shows the battery status. When the battery status is good, is displayed;...
Page 59: Checking The Patient Controller Battery Status
Checking the Patient Controller Battery Status You can view the patient controller battery status in the top right corner of the screen, see "Start-up Screen" (page 35). As the battery is used, the battery indicator shows the remaining charge. Recharge the patient controller using only the provided Apple™...
Page 60: Protecting Access To The Patient Controller
Protecting Access to the Patient Controller To prevent unauthorized access to your patient controller app, set up a passcode using the instructions provided in the Apple™ manual at http://www.apple.com/support/ipodtouch/. Troubleshooting This section provides troubleshooting procedures to help you identify and solve problems that may occur. NOTE: If you encounter problems other than those described in this section or if your device is lost or damaged, contact Technical...
Page 61 Table 6. Troubleshooting messages Message Solution 2. Tap Settings on the patient controller Home screen. 3. Tap Bluetooth, and then tap the Bluetooth wireless technology toggle button. NOTE: If you turn Bluetooth wireless technology off and on or reset the app then it will take longer to reconnect to your...
Page 62 Table 6. Troubleshooting messages Message Solution Generator Unavailable Make sure your generator is in range and the battery Make sure the generator has enough charge (see is in range and has "Checking the Generator enough battery power. Battery Status" (page 54)), then try connecting to your generator again.
Page 63 Table 6. Troubleshooting messages Message Solution Connection Lost Try connecting to your generator again. A magnet was used to place the generator in If you continue to the Bluetooth pairing encounter this problem, mode. contact Technical Support. Connection Not Ready Try connecting to your generator again.
Page 64 Table 6. Troubleshooting messages Message Solution Replace Generator Contact your physician. The generator has reached the end of its service. Contact your physician to schedule a replacement. Therapy is OFF Tap Dismiss. Therapy was turned off because the program needed to be reset. Therapy is OFF Tap View Programs to select another program.
Page 65 The generator could not deliver the desired If you continue to strength. encounter this problem, contact your physician. Contact your clinician if the problem persists. Unsupported Device Use the device provided by St. Jude Medical. This application is not compatible with this device.
Page 66 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Cannot locate Patient controller Swipe through patient controller app is not on screens from the app. patient controller patient controller Home screen. Home screen to locate app. Search for the app using iOS software search...
Page 67 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Correct plug Connect the adapter (voltage appropriate plug converter) is not adapter (voltage connected to the converter) to the charger. charger. Charger is Replace the defective. charger.
Page 68 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Screen is If the patient damaged or controller malfunctioning. appears to be powered on but without display, the screen may be defective. Contact Technical Support.
Page 69 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient controller Patient controller Perform a soft will not respond has locked up. reset. to input. 1. Press and hold the Power button until the slide to power off bar appears.
Page 70 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient controller Patient controller Wake up the is not is off or has patient communicating timed out and is controller. with the in standby generator. mode. Patient controller Charge the battery is...
Page 71 Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Move the devices so they share line of sight. Do not operate other wireless devices at the same time. Wait a few minutes and try connecting again.
Page 72: Technical Support
Table 7. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Patient controller Replace the is damaged or patient malfunctioning. controller. Technical Support For technical questions and support for your product, use the following information: +1 855 478 5833 (toll-free within North America) ...
Page 73 1. Make sure the device is connected to a Wi-Fi network. 2. Tap the App Store icon on the patient controller Home screen of your device. 3. Enter St. Jude Medical in the Search field. 4. Once you locate the correct app, follow the onscreen prompts.
Page 74: Appendix B: Pairing The Patient Controller To The Generator
NOTE: If you do not have an Apple ID, create one using the onscreen prompts and the instructions above. NOTE: If you encounter problems downloading the app, contact Technical Support. Appendix B: Pairing the Patient Controller to the Generator The following instructions outline the steps for pairing the patient controller to the generator.
Page 75: Appendix C: Regulatory Statements
6. Tap Pair to pair the patient controller and generator. The "Connecting to Generator…" message displays while the patient controller is connecting to the generator. Appendix C: Regulatory Statements NOTE: These statements are applicable to the generator. For Regulatory Statements regarding the patient controller, refer to the Apple™...
Page 76: Statement Of Compliance With License-Exempt Rss Standard (Canada)
correct the interference by one or more of the following measures: Reorient or relocate the receiving antenna.  Increase the separation between the equipment  and receiver. Connect the equipment into an outlet on a circuit  different from that to which the receiver is connected.
Page 77: Declaration Of Conformity (Industry Canada) Notice To Users Of Radio And Television
Identification Information for Product Registration This device has a label that contains, among other information, a product identifier in the following format: Table 8. St. Jude Medical Infinity™ Registration identification information Identifier Type Registration Identifier FCC Registration Number...
Page 78: Wireless Technology Information
Wireless Technology Information The following table summarizes the technical details of the Bluetooth Smart wireless technology as it is ® implemented in the device. Table 9. 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...
Page 79: Radio Transmitter, Cables, Transducers
Table 9. Bluetooth Smart wireless technology information Protocol Bluetooth Smart wireless technology *EIRP = Equivalent isotropically radiated power Radio Transmitter, Cables, Transducers The device contains a radio transmitter/receiver with the following parameters. Radio transmitter parameters: Frequency (range): 2.4000 to 2.4835 GHz ...
Page 80: Quality Of Service For Wireless Technology
The radio receiver in the device is using the same frequency and bandwidth as the transmitter. Cables and transducers: Cables and transducers are not used during normal use of the device nor while programming the device. Quality of Service for Wireless Technology Bluetooth Smart wireless technology enables ®...
Page 81 resent if not successfully received. Each key press may transmit up to 4 data packets with up to 20 bytes per packet, depending on the number of packets that need to be transmitted (i.e., if there is only one packet to transmit, only one packet will be transmitted).
Page 82 A proprietary algorithm that detects and prevents  an unauthorized user from attempting to pair with the generator. Troubleshooting for Wireless and Coexistence Issues If you experience issues with the wireless communication between the generator and the patient controller, try the following: Decrease the distance between the devices ...
Page 83: Appendix D: Electromagnetic Compatibility Guidelines
Appendix D: Electromagnetic Compatibility Guidelines The generator, hereafter the device, is medical equipment and should be used with the following guidance. The device requires special precautions with regard to electromagnetic compatibility (EMC) and should be used in accordance with the information provided in this manual.
Page 84 CAUTION: To avoid increasing emissions or decreasing immunity from a device or system, use only St. Jude Medical- approved components with this system. Do not use St. Jude Medical components with other non-St. Jude Medical devices or systems. Table 10.
Page 85 Table 11. Guidance and manufacturer’s declaration – electromagnetic immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Electrostatic ±8 kV contact ±8 kV contact The relative humidity should discharge (ESD) ±15 kV air ±15 kV air be at least 5%. IEC 61000-4-2 Electrical fast ±2 kV for...
Page 86 Table 11. Guidance and manufacturer’s declaration – electromagnetic immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Power 30 A/m 30 A/m Power frequency frequency magnetic fields (50/60 Hz) should be at magnetic field levels IEC 61000-4-8 characteristic of a typical location in a typical...
Page 87 Table 11. Guidance and manufacturer’s declaration – electromagnetic immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Recommended separation distance d=0.58√P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the...
Page 88 Table 11. Guidance and manufacturer’s declaration – electromagnetic immunity Immunity Test IEC 60601 Compliance Electromagnetic Test Level Level Environment Guidance Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Page 89 absorption and reflection from structures, objects, and people. Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
Page 90 Table 12. Guidance and manufacturer’s declaration – proximity fields Proximity IEC 60601 Test Compliance Electromagne Test Level Level Environment Guidance 385 MHz: 27 V/m 27 V/m Recommende 61000-4-3 @ 18 Hz pulse d separation modulation distance d = 0.3 m 450 MHz: 28 V/m 28 V/m @ FM modulation...
Page 91 30 cm (12 inches) to any part of the EPG, including cables specified by St. Jude Medical. Otherwise, performance degradation may occur. NOTE: For the frequency bands in the table above, use the specified recommended separation distance.
Page 92 Table 13. Recommended separation distances between portable and mobile RF communications equipment and the device Rated Separation Distance According to Frequency of Maximum Transmitter (m) Output Power 150 kHz to 80 to 800 MHz to of Transmitter 80 MHz 800 MHz 2.5 GHz d=1.17√P d=0.18√P...
Page 93: Radio Frequency Information
NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Radio Frequency Information The effective radiated power is below the limits as specified in: USA: FCC 47 CFR Part 15:2012...
Page 96 St. Jude Medical 6901 Preston Road Plano, Texas 75024 USA +1 855 478 5833 +1 651 756 5833 St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium +32 2 774 68 11 sjm.com...