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Abbott St.Jude Medical Patient Controller 3875 User Manual
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Abbott St.Jude Medical Patient Controller 3875 User Manual

Abbott St.Jude Medical Patient Controller 3875 User Manual

For deep brain stimulation systems
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St. Jude Medical™ Patient
Controller
For Deep Brain Stimulation Systems
Model 3875
User's Guide

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Summary of Contents for Abbott St.Jude Medical Patient Controller 3875

  • Page 1 St. Jude Medical™ Patient Controller For Deep Brain Stimulation Systems Model 3875 User's Guide...
  • Page 2 CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. ™ 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 Bluetooth SIG, Inc.

  • Page 3: Table Of Contents

    Contents About This Guide ............1 Symbols and Definitions ........1 Terms Used in This Document ......6 Prescription and Safety Information ......7 Intended Use ............7 Indications for Use ..........7 Contraindications ..........8 MRI Safety Information ........8 Warnings .............
  • Page 4 Maintaining the Generator and Patient Controller ..65 Checking the Generator Battery Status ....65 Checking the Patient Controller Battery Status ... 66 Caring for the Patient Controller ......67 Troubleshooting ............67 Troubleshooting Messages for MRI Mode ..78 Cybersecurity ............

  • 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 and on some of the products and packaging: NOTE: For symbols and definitions for the patient controller, refer to the user guide...
  • Page 6 Table 1. Symbols and definitions Symbol Definition Follow instructions for use on this website Device 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 safety in the MR environment within the defined conditions.
  • Page 7 Table 1. Symbols and definitions Symbol Definition Keep dry Ingress protection rating for a device that is protected from the intrusion 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 manufacture...
  • Page 8 Table 1. Symbols and definitions 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 Identification Prescription use only...
  • Page 9 Abbott Medical. Authorized European representative European conformity, affixed in accordance with the relevant provisions of AIMD directive 90/385/EEC. Hereby, Abbott Medical declares that this device is in compliance with the essential requirements and other relevant provisions of this directive.

  • Page 10: Terms Used In This Document

    Table 1. Symbols and definitions Symbol Definition Australian Communications and Media Authority (ACMA) and New Zealand Radio Spectrum Management (RSM) Regulatory Compliance Mark (RCM) This equipment is certified for type certification pursuant of Article 38-24 of the Japan Radio Law Terms Used in This Document This section contains definitions of some of the terms used in this document.

  • Page 11: Prescription And Safety Information

    Prescription and Safety Information Read this section to gather important prescription and safety information. Intended Use This 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 programs.

  • Page 12: Contraindications

    Contraindications This system is contraindicated for patients who meet the following criteria: Are unable to operate the system  Have unsuccessful test stimulation  The following procedures are contraindicated for patients with a deep brain stimulation system. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave ...

  • Page 13: Warnings

    Additionally, before receiving an MRI scan, inform the healthcare professional that you are implanted with a neurostimulation system. If you do not have an MR Conditional system, you cannot receive an MRI. Do not bring your patient controller into the scanner magnet room.
  • Page 14 High amplitudes 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/cm , a screen will...
  • Page 15 Device components. The use of components not approved for use by Abbott Medical may result in damage to the system and increased risk to the patient.
  • Page 16 Electrosurgery devices. Electrosurgery devices may harm you or damage your neurostimulation system. If you need to receive a procedure using an electrosurgery device, place your generator in Surgery Mode. Your physician may only use bipolar electrosurgery devices and they should keep the device as far away from your neurostimulation system as possible.
  • Page 17 Cremation. The IPG should be explanted before cremation because the IPG could explode. Return the explanted IPG to Abbott 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 18 Return of symptoms and rebound effect. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). In rare cases, this can create a medical emergency.

  • Page 19: Precautions

    To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Application modification. To prevent unintended stimulation, do not modify the operating system in any way. Strangulation.
  • Page 20 Avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high-voltage power lines, radio- frequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).
  • Page 21 Long-term safety and effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Safety and effectiveness has not been established for patients with neurological disease other than Parkinson’s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression;...
  • Page 22 Hospital and Medical Environments Medical tests and procedures. Before undergoing medical tests or procedures (such as therapeutic radiation or electrolysis), contact your physician to determine if the procedure will cause you injury or damage your neurostimulation system. Specifically, you should be aware that medical devices such as electrohydraulic lithotriptors, therapeutic X rays, computerized tomography (CT) scans, cobalt machines, and linear accelerators may cause damage...
  • Page 23 Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted device. External defibrillators. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. External defibrillation can cause induced currents in the lead- extension portion of the neurostimulation system.
  • Page 24 Home and Occupational Environments Patient activities and environmental precautions. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly.
  • Page 25 implant site. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Scuba diving or hyperbaric chambers. Avoid scuba diving below 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA).
  • Page 26 Therapeutic magnets. Patients should be advised to not use therapeutic magnets. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. Physician instructions. Always follow the programs and therapy instructions established for you by your physician.
  • Page 27 Return it to Abbott Medical for proper disposal. 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 Abbott Medical for service.

  • Page 28: Adverse Effects

    Adverse Effects Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); subcutaneous hemorrhage or seroma; hematoma; cerebrospinal fluid leakage or cerebrospinal fluid abnormality;...
  • Page 29 paralysis (loss of motor function, inability to move); stroke and death. Possible deep brain stimulation complications. Deep brain stimulation complications include, but are not limited to, the following: Device-related complications  Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture Loss of therapeutic benefit as a result of...
  • Page 30 Persistent pain, tightness, or redness at the incision sites or general pain General erosion or local skin erosion over the Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck) Impaired wound healing (e.g., incision site drainage) or abscess formation Additional neurosurgical procedure to manage one of the above complications or to replace a...
  • Page 31 Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural...

  • Page 32: Patient Expectations

    Sweating Fever Hiccups Cough Cramps Worsening existing medical conditions 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.
  • Page 33 be surgically removed. You also need to be aware that you cannot undergo diathermy procedures, electroshock therapy, transcranial magnetic stimulation or MRIs as discussed in “Contraindications” (page 8). Talk to your doctor about the risks associated with placement and use of a deep brain stimulation system.

  • Page 34: 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: In this document, the term "patient controller"...

  • Page 35: About Your System

     Patient magnet  Patient controller (a device provided by  Abbott Medical or a compatible personal Apple‡ iOS‡ device) NOTE: For more information on compatible devices, see "Appendix A: Downloading the Patient Controller App" (page 84). The IPG connects to the implanted extensions, which connect to the leads implanted in the brain.
  • Page 36 Figure 1. Interaction between major system components 1. Patient controller 2. IPG 3. Extensions 4. Leads 5. Patient magnet...

  • Page 37: Overview Of The Patient Controller

    App" (page 84) for more information on compatible devices and for instructions on downloading the patient controller app. Using a Provided Device If you are using a patient controller provided by Abbott Medical, refer to the following figure for the patient controller features.
  • Page 38 Figure 2. Patient controller features 1. Power button 2. Patient controller Home button...
  • Page 39 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 40 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 41: Items You Will Receive

    Items You Will Receive If you are using a patient controller provided by Abbott Medical, you will receive the following items to use with your system: Patient controller and charging cord  Protective case for the patient controller  Patient magnet ...

  • Page 42: Your Personal Identification Card

    Your physician will complete the card and give it to you. Once you or your physician submit a patient registration form, Abbott will mail you a permanent identification card. The registration card does the following things: Identifies you as having an implanted medical ...

  • Page 43: Directions For Use

    NOTE: In some cases, use of Bluetooth ® wireless technology media devices (such as headphones or speakers) may prevent the patient controller from connecting to your generator. Abbott Medical recommends disconnecting these accessories before you attempt to adjust your therapy.

  • Page 44: Overview Of The Therapy Screen

    While your app starts up, you will see the 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 with the generator, the Therapy screen appears.
  • Page 45 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...
  • Page 46 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 47 Table 3. Therapy screen descriptions Screen Section Description or Button Name Mode Displays the active dosage (Continuous or Intermittent). Tap to display the Mode screen and enable Airplane Ready mode, Surgery Mode, or MRI Mode. See "Mode" (page 46) for more information.

  • Page 48: Starting And Stopping Stimulation

    Starting and Stopping Stimulation You may start and stop stimulation using the patient controller app or the included magnet if your physician has enabled magnet use. 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 ...
  • Page 49 Starting and Stopping Stimulation Using the Magnet If your physician has enabled magnet use, you may start and stop stimulation with a magnet. To start or stop stimulation using the magnet, follow these steps: 1. Take the keeper bar off the magnet. Figure 5.

  • Page 50: Mode

    Mode Depending on the programmed dosage, Continuous or Intermittent is displayed on the Therapy screen. Continuous – provides nonstop stimulation  Intermittent – automatically alternates stimulation  on and off for the preset periods in the selected program; displays the remaining time in the current on or off period NOTE: In neurostimulation therapy, “dose”...
  • Page 51 To enable Airplane Ready mode, tap Airplane  Ready to view the Airplane Ready screen. Follow the instructions on the 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 ...

  • Page 52: 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 Abbott Medical before your procedure. Contact your clinician before your procedure to learn more about any risks.
  • Page 53 Setting the IPG to Surgery Mode To set your IPG into Surgery 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.
  • Page 54 Disabling the Surgery Mode After your procedure, you need to disable 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 the IPG is in Surgery Mode. Figure 8.

  • Page 55: Using The Mri Mode Features

    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. Using the MRI Mode Features You may be implanted with the parts that make up a Magnetic Resonance (MR) Conditional system, which allows you to receive an MRI scan if all the requirements for the implanted parts and scanning...
  • Page 56 Tap Mode on the Therapy screen to display the Mode screen. The MRI Mode option is available if implanted parts of your system are approved MR Conditional models. Preparing for an MRI Scan If you have an MR Conditional system and will receive an MRI scan, follow these guidelines: Charge your patient controller before the ...
  • Page 57 Setting 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 screen...
  • Page 58 3. Tap the MRI Mode toggle button to turn on MRI mode. 4. When the "Set Generator to MRI Mode" message appears, tap Continue. Stimulation stops, and the patient controller app checks the system for any issues. If the checks are successful, the "Proceed with MRI"...
  • Page 59 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 OFF.

  • Page 60: 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 61 Figure 11. Programs screen 1. Cancel button 2. Program name 3. Left arrow 4. Right arrow 5. Program indicator 6. Select This Program button...
  • Page 62 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 63: 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 64 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...
  • Page 65 Table 5. Strength screen descriptions Screen Section Description or Button Name Done button Tap Done to save changes and return to the Therapy screen. Side 1 tab Tap to view and modify strength for Side 1. Side 2 tab Tap to view and modify strength for Side 2.

  • Page 66: System Information

    If the MultiStim™ programming feature is included as part of your therapy, you will see the following screen. Figure 13. Strength screen with MultiStim programming feature System Information on the Therapy screen to display the system information. From these screens, you can view the information for your generator, leads and extensions, and patient controller app by tapping the corresponding buttons.
  • Page 67 Figure 14. System information Generator screen 1. Done button 2. Manuals button 3. Generator button 4. Leads/Extensions button 5. Patient Controller button...
  • Page 68 Table 6. System information descriptions Screen Section Description or Button Name Done button Tap Done to save changes and return to the Therapy screen. Manuals button Tap to view information about how to download the MRI Procedure Information manual. Generator button Tap to view information about your generator, such as the generator model number.

  • Page 69: 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 Generator information screen shows the battery status.

  • Page 70: Checking The Patient Controller Battery Status

    Checking the Patient Controller Battery Status Be sure to monitor the patient controller battery status (indicated in the top right corner of the screen). As the battery is used, the battery indicator shows the remaining charge. Recharge the patient controller using only the Apple‡...

  • Page 71: Caring For The Patient Controller

    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 cloth and a small amount of mild soap. Do not use a cloth that is saturated.
  • Page 72 System Problem Try the action again. If you continue to encounter this The system encountered problem, contact Technical a problem. Contact Support. Abbott if this problem persists.
  • Page 73 Table 7. 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 65)), then try connecting to your generator again.
  • Page 74 Table 7. 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 75 Table 7. Troubleshooting messages Message Solution 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. You will need to select another program. Strength was Decreased Try adjusting strength again.
  • Page 76 Table 7. Troubleshooting messages Message Solution Unsupported Device Use the device provided by Abbott Medical or a This application is not compatible personal compatible with this Apple‡ iOS‡ device. device. NOTE: For more information on compatible devices, see "Appendix A: Downloading the Patient Controller App"...
  • Page 77 Table 8. 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 the iOS search...
  • Page 78 Table 8. 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 79 Table 8. 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. Patient controller Patient controller Perform a soft will not respond...
  • Page 80 Table 8. 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 81 Table 8. Possible causes and solutions for potential 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 speakers). Wait a few minutes and try connecting again.

  • Page 82: Troubleshooting Messages For Mri Mode

    Table 8. Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Turn on Bluetooth ® wireless technology using the instructions in the "Troubleshooting messages" table. Patient controller Replace the is damaged or patient malfunctioning. controller. Troubleshooting Messages for MRI Mode The following tables show issues you may encounter while setting MRI mode.
  • Page 83 Table 9. Possible causes and solutions for potential issues with opening the MRI Mode screen from the Mode screen Problem Possible Cause Solution MRI is Not A part of the Contact your Permitted is system is not clinician for help displayed MR Conditional.
  • Page 84 Table 10. Troubleshooting messages for MRI mode Message Description MRI is Not Advised The generator is not in MRI mode, and an MRI There may be a problem scan cannot be performed. with the implanted lead(s). Contact your clinician. MRI is Not Advised The generator is not in MRI mode, and an MRI There may be a problem...

  • Page 85: Cybersecurity

    Cybersecurity To protect the devices, products, and systems that connect patients to healthcare professionals and institutions, Abbott takes a broad and deep approach to ensuring safety, privacy, and security. Visit the information page available at www.NMCybersecurity.Abbott to learn more about the Abbott neuromodulation cybersecurity program.

  • Page 86: Guidelines For Secure Use

    A unique key for each unit that is checked during  each transmission. Built-in pairing that specifies valid and legitimate  pairing among units. Proprietary authentication in addition to the  pairing procedure specified in Bluetooth Smart ® wireless technology, which includes an element of proximity.

  • Page 87: Technical Support

    Controller App via www.NMmobiledevicesync.com/dbs. Technical Support For technical questions and support for your product, use the following information: +1 855 478 5833 (toll-free within North America)  +1 651 756 5833  For additional assistance, call your local Abbott Medical representative.

  • Page 88: Appendix A: Downloading The Patient Controller App

    You must download the patient controller app to your patient controller (either a device provided by Abbott Medical or a compatible personal Apple‡ iOS‡ device) in order to use the patient controller with your generator. The patient controller app is compatible...
  • Page 89 1. Make sure the device is connected to a Wi-Fi‡ network. 2. Tap the App Store icon on the patient controller Home screen. 3. Enter Abbott Patient Controller in the Search field. 4. Once you locate the correct app, follow the onscreen prompts.

  • Page 90: Appendix B: Pairing The Patient Controller To The Generator

    Appendix B: Pairing the Patient Controller to the Generator The following instructions outline the steps for pairing the patient controller to the generator. 1. Place the magnet perpendicular to the generator for 10 seconds. 2. Tap the patient controller app. The patient controller app launches.

  • Page 91: Appendix C: Regulatory Statements

    Appendix C: Regulatory Statements NOTE: These statements are applicable to the generator. For Regulatory Statements regarding 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; or, on the patient controller Home screen, tap Settings >...

  • Page 92: Statement Of Compliance With License-Exempt Rss Standard (Canada)

    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. Consult the dealer or an experienced radio/TV ...

  • Page 93: Declaration Of Conformity (Industry Canada) Notice To Users Of Radio And Television

    Declaration of Conformity (Industry Canada) Notice to Users of Radio and Television This Class B digital apparatus meets all the requirements of the Canadian interference-causing 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 11.

  • Page 94: 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 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...

  • Page 95: Radio Transmitter, Cables, Transducers

    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  Bandwidth (-15dB): 2.398 to 2.4855 GHz  Channel: 40 logical channels using AFH  Modulation: GFSK ...

  • Page 96: Quality Of Service For Wireless Technology

    Quality of Service for Wireless Technology Bluetooth Smart wireless technology enables ® communication between the generator and the patient controller. The quality of the wireless communication link varies 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 patient controller screen.
  • Page 97 For information on how to improve connection issues, please refer to “Troubleshooting for Wireless and Coexistence Issues” (page 93). 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 100 Abbott Medical 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 *600090479*...

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