St. Jude Medical Prodigy 3855 User Manual
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St. Jude Medical Prodigy 3855 User Manual

Patient programmer
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Prodigy™ Patient Programmer
User's Guide
ARTEN100147784A.pdf 1
9/15/2016 12:42:32 PM

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Summary of Contents for St. Jude Medical Prodigy 3855

  • Page 1 Prodigy™ Patient Programmer User's Guide ARTEN100147784A.pdf 1 9/15/2016 12:42:32 PM...
  • 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, Inc. and its related companies.

  • Page 3: Table Of Contents

    Contents About This Guide................... 1 Symbols and Definitions ................1 Additional Symbols for Product Labels ............2 Terms Used in This Document ..............3 Prescription and Safety Information ............... 3 Intended Use ................... 3 Indications for Use ................... 3 Contraindications ..................3 Warnings ....................
  • Page 4 Saving an X Program ................32 Troubleshooting Other Potential Problems ..........32 Service and Ordering Information ..............34 Customer Service Information ..............34 Ordering Information ................35 Appendix A: Regulatory Statements ............. 35 Statement of FCC Compliance ..............35 Disposal Guidelines for Battery-Powered Devices ........36 Appendix B: Electromagnetic Compatibility Guidelines .........

  • Page 5: About This Guide

    About This Guide This guide explains how to use the St. Jude Medical™ Prodigy™ patient programmer (Model 3855 or 3856) with your Prodigy™ neurostimulation system. If you have any questions about your system, contact Customer Service. Symbols and Definitions The following symbols may be used in this document and on some of the...

  • Page 6: Additional Symbols For Product Labels

    Authorized European representative 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...

  • Page 7: Terms Used In This Document

    Genesis™ programmer case Prodigy™ patient programmer Terms Used in This Document This section contains definitions of some of the terms used in this document. Amplitude. A measure of the strength of the stimulation. Burst program. A program where the stimulation frequency consists of a group of pulses in rapid succession followed by a period without pulses before repeating the pulse group.

  • Page 8: Warnings

    Warnings The following warnings apply to the use of this neurostimulation system: Diathermy therapy. You cannot have any short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on your body if you have any part of a neurostimulation system implanted.

  • Page 9: Precautions

    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. Precautions The following precautions apply to the use of this neurostimulation system: Keep the programmer dry.
  • Page 10 Previous Screen key. Device components. The use of components that are not approved by St. Jude Medical with this system may result in damage to the system and increased risk to the patient. Magnet usage. The magnet provided with the system is a high-powered magnet intended for use solely with the system.

  • Page 11: Adverse Effects

    Adverse Effects In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary  movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.) Undesirable changes in stimulation, which may be related to cellular ...

  • Page 12: About Your Programmer

    The following image shows how the major system components are intended to interact. Interaction between main system components Figure 1. 1. Rapid Programmer system (clinician only) 2. Patient Programmer 3. IPG 4. Leads 5. Charging System NOTE: This manual provides instructions for using the patient programmer. For instructions about the charging system, see the charging system's user guide.

  • Page 13: Your Personal Identification Card

    Patient Communication Battery pack AAA batteries (3) programmer wand Patient magnet Programmer Patient binder case Your Personal Identification Card A personal medical identification card is included in the package of your programmer. This card does the following things: Identifies you as having an implanted medical device ...

  • Page 14: Parts Of The Patient Programmer

    Parts of the Patient Programmer The following image shows the different parts of the patient programmer. Parts of the Patient Programmer Figure 2. 1. Amplitude Decrease key 2. Amplitude Increase key 3. Display screen 4. Power key 5. Balance key 6.

  • Page 15: Setting Up The Patient Programmer

    Each time before using the system, inspect the device and its accessories for damage. Avoid using a damaged device or accessory. Return it to St. Jude Medical for evaluation. Turning the Programmer On and Off To turn the programmer on, press the Power key.
  • Page 16 Plug the wand into the programmer Figure 3. 3. Press the Power key to turn on the programmer. The Diagnostic Test screen appears. 4. Place the flat, circular end of the wand over the IPG site. Place the wand over the IPG site Figure 4.

  • Page 17: About The Operational Display Screen

    NOTE: The programmer will try to locate the IPG for about 5 seconds before a screen appears to retry communication. If the programmer does not establish communication, move the wand slowly over the IPG site in small circular movements until you achieve communication. NOTE: After you have established communication with the IPG, keep the wand in place.

  • Page 18: Changing Programmer Settings

    is blank. To allow you to enter other modes, it displays one of the following icons:  The Program icon (P) indicates program selection mode. The Menu icon (M) indicates the menu mode.  The Battery icon (B) indicates IPG battery capacity mode. ...

  • Page 19: Displaying Ipg And Programmer Information

    The Menu screen Figure 9. 1. Backlighting icon 2. Contrast icon 3. Volume icon 4. Authorization icon 5. Information icon 3. Press either Scroll key until the arrow is under the icon of the setting that you want to change: backlighting, contrast, or volume. 4.

  • Page 20: Replacing The Programmer Batteries

    4. Press the Select key. A screen appears showing information about the programmer and its remaining battery power. Programmer information screen Figure 12. 5. To view the screen showing IPG information, press the Scroll key on the right. To view the screen showing the programmer information again, press the Scroll key on the left.

  • Page 21: Using The Programmer

    Remove the battery pack from the programmer Figure 14. 3. Remove the AAA batteries from the battery pack, and insert new AAA batteries into the battery pack, ensuring that the + and - signs on the batteries line up with the signs in the battery pack. 4.
  • Page 22 Scroll to the Program icon (P) Figure 15. 2. Press the Select key. The Program Selection screen appears showing the currently selected program in the center of the screen. Access the Program Selection screen Figure 16. 3. Press either Scroll key until the program you want appears in the center of the screen.

  • Page 23: Starting Stimulation

    Starting Stimulation To start stimulation, follow these steps: 1. From the Operational Display screen, press or press and hold the Amplitude Increase key. The amplitude level shown on the active amplitude bar will increase. 2. Press the Amplitude Increase key to increase stimulation or the Amplitude Decrease key to decrease stimulation to a comfortable level.
  • Page 24 Stopping Stimulation Using the Magnet The system comes with a magnet that can turn off the IPG or turn it on and off. How the IPG functions depends on the program settings. A program can be set with one of the following magnet modes: Magnet off.

  • Page 25: Using The Stim Set Balance Feature

    Take the keeper bar off the magnet Figure 22. 1. Magnet 2. Keeper bar 2. Place the magnet directly over the IPG. 3. Hold the magnet in place for two seconds. 4. Remove the magnet, replace the keeper bar, and store the magnet. 5.

  • Page 26: About The Stimulation Modes

    Stim Set Balance screen Figure 23. NOTE: The previous figure shows adjustment bars for eight stim sets. If a program has only one stim set, only one adjustment bar will be displayed. NOTE: If the amplitude is at zero, the following screen will be displayed. To use the Stim Set Balance feature for a stimulation program, press the Amplitude Increase key to increase amplitude;...
  • Page 27 Continuous Mode Continuous mode provides continuous stimulation to the patient. When the system is turned on, it delivers therapy until it is manually turned off. Continuous mode is the default mode and does not display a mode indicator on the Operational Display screen. The Operational Display screen in continuous mode Figure 25.

  • Page 28: Using The Mri Mode Features

    program is set to bolus mode, the letter B is displayed on the Operational Display screen with information about the “on” or “off” time remaining. Description of the Operational Display screens in bolus mode Table 3. Operational Description Display Screen Stimulation is on for the time displayed (in hours and minutes or in minutes and seconds).

  • Page 29: Preparing For An Mri Scan

    technician to help them find out if you have the components of an MR conditional system. Your patient programmer also provides information about whether your IPG is part of an MR conditional system. To see if you have an IPG that is approved to be a part of an MR conditional system, do the following: 1.

  • Page 30: Disabling The Mri Mode

    Scroll the the MRI mode icon Figure 27. 2. Press the Select key on the programmer. The following screen appears. Enter MRI mode screen Figure 28. 3. Press the Select key. The programmer stops stimulation, checks the impedance on the lead electrodes, and checks the remaining battery capacity of the IPG.

  • Page 31: Recharging Your Ipg

    MRI mode screen Figure 30. 2. Press the Select key. The following screen appears. Exit MRI mode screen Figure 31. 3. Press the Select key. The programmer disables MRI mode, and a screen appears similar to the following Operational Display screen showing that stimulation is off.

  • Page 32: Checking The Remaining Ipg Battery Capacity

    Checking the Remaining IPG Battery Capacity To check the remaining battery capacity of the IPG, follow these steps: NOTE: To get an accurate measurement, wait two minutes after charging the IPG before checking the IPG battery capacity. 1. Establish communication with the IPG. See “Communicating With the IPG”...

  • Page 33: Troubleshooting

    Safe storage and operating conditions Table 4. Temperature Storage -10°C–55°C (14°F–131°F) Operating 10°C–40°C (50°F–104°F) Relative humidity Storage 10%–90% (noncondensing) Operating 30%–75% Pressure Storage 70–150 kPa (10.2–21.8 psi) Operating 70–106 kPa (10.2–15.4 psi) Troubleshooting This section provides troubleshooting procedures to help you identify and solve problems that may occur.
  • Page 34 Programmer Screen Solution Message Corrupt Have your physician edit the current program. program (off) Corrupt Select another program or have your program physician edit the current program. (reselect program) Diagnostic Call Customer Service. error IPG battery Stimulation continues, but the IPG battery is low.

  • Page 35: Troubleshooting Messages For Mri Mode

    Troubleshooting Messages for MRI Mode The following table shows programmer screens that you may see while setting MRI mode before a scan. If you see any of these screens, follow the guidelines to help troubleshoot the issue. Troubleshooting screens for MRI mode Table 6.

  • Page 36: Saving An X Program

    The system check failed Contact Customer Service for because of a problem with technical support. the IPG. Saving an X Program Your programmer is authorized to work specifically with your IPG. If your programmer is not available, your physician can use another programmer to adjust the stimulation parameters in your IPG.
  • Page 37 Problem Possible Cause Possible Solution IPG is in the "off" phase in Check to see if the IPG is in the cycle or bolus mode. the off phase in the cycle or bolus mode. Wait until the phase is completed. IPG is in MRI mode.

  • Page 38: Service And Ordering Information

    This section provides information for contacting Customer Service and for ordering replacement parts and accessories. Customer Service Information For help with a St. Jude Medical™ neuromodulation product, including technical service or repair, contact Customer Service using the following information: ARTEN100147784A.pdf 38...

  • Page 39: Ordering Information

    St. Jude Medical St. Jude Medical 6901 Preston Road Coordination Center BVBA Plano, TX 75024 The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem +1 972 309 8000 Belgium +1 972 309 8150 Fax +32 2 774 68 11 Ordering Information To order parts, contact Customer Service.

  • Page 40: Disposal Guidelines For Battery-Powered Devices

    Sorting such waste and removing it from other forms of waste lessens the contribution of potentially toxic substances into municipal disposal systems and into the larger ecosystem. Return the device to St. Jude Medical at the end of its operating life. Appendix B: Electromagnetic Compatibility Guidelines The Prodigy™...
  • Page 41 Emissions Compliance Electromagnetic Environment Guidance Test RF emissions Group 1 The device uses RF energy for its internal and system interface functions. Therefore, CISPR 11 its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
  • Page 42 Guidance and Manufacturer's Declaration — Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should ensure that it is used in such an environment. Immunity Test IEC 60601 Compliance Electromagnetic Test Level...
  • Page 43 Guidance and Manufacturer's Declaration— Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below. The customer or user of the device should ensure that it is used in such an environment. Immunity Compliance Electromagnetic Environment Test 60601 Level Guidance...
  • Page 44 measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device. Over the frequency range 150 kHz and 80 MHz, field strengths should be less than 3 V/m.

  • Page 45: Appendix C: Ce Mark Date

    NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. Appendix C: CE Mark Date The following table lists the year in which the CE mark was awarded by model number.

  • Page 46: Index

    Index Patient programmer Description ......8, 9 Information ......14 Setup ........10 Adverse effects ......7 Precautions ........ 5 Ampliude ....... 3, 13, 18 Recharging the IPG .. 7, 27, 28, 31 Backlighting ......14 Replacing the batteries ..... 16 Cleaning the programmer ..
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  • Page 50 +32 2 774 68 11 Manufacturing Site: Manufacturing Site: St. Jude Medical Puerto Rico LLC St. Jude Medical Operations (M) Sdn. Bhd. Lot A Interior - #2 Rd Km. 67.5 Plot 102, Lebuhraya Kampung Jawa, Santana Industrial Park Bayan Lepas Industrial Zone...

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Prodigy 3856

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