Rapid Programmer System, Version 3.7. Model Clinician s Manual

Transcription

1 Rapid Programmer System, Version 3.7 Model 3834 Clinician s Manual

2 CAUTION: The Rapid Programmer system is part of a regulated medical device system and any changes to the system may be performed only with express written authorization from St. Jude Medical. Changes to the system include the installation of any software, addition of hardware that is not approved by St. Jude Medical, or modifications to the operating system of the personal digital assistant (PDA). The result of these actions may cause the PDA to malfunction or become inoperable. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. Information in this document is subject to change without notice and does not represent a commitment on the part of St. Jude Medical. The Rapid Programmer system software, excluding any user-input data, is furnished under a license agreement or nondisclosure agreement and may be used or copied only in accordance with the terms and conditions of the applicable agreement. Bluetooth is a registered trademark of Bluetooth SIG, Inc. 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. Pat St. Jude Medical, Inc. All rights reserved.

3 Clinician s Manual Contents Prescription and Safety Information Intended Use Prescription Information Warnings Precautions Device Compatibility Guidelines Product Description Contents of Package Parts of the Rapid Programmer System Setting Up the Rapid Programmer System Inserting the System Battery Charging the System Turning the System On and Off Connecting a Patient Programmer Connecting an MTS System Inserting a Database Card Removing a Database Card Replacing the System Battery Getting Started Navigating the Main Menu Screen Adjusting Backlight Settings Adjusting Screen Brightness Setting the Time and Date Checking the Programmer Battery Status Adjusting the Automatic Shutoff Settings Calibrating the Touch Screen Adjusting the Volume Starting the Demo Rapid Programmer System Clinician s Manual i

4 Intraoperative and Postoperative Programming Buttons and Icons on the Programming Screens Starting an Intraoperative Testing Session Starting a New Programming Session or Resuming the Previous Session Selecting the Lead Configuration Resetting the Hours Used for the MTS System Adding a New Program Copying a Selected Program Editing a Selected Program Deleting a Selected Program, Stim Set, or Burst Pulse Switching Between Tonic Mode and BurstDR Stimulation Mode Configuring Electrode Polarities Adjusting Pulse Width Adjusting Frequency for Tonic Programs Adjusting Frequency for BurstDR Stimulation Programs Adjusting Amplitude and Step Size Setting Perception and Comfort Amplitudes for Tonic Programs Setting the Target Amplitude for BurstDR Stimulation Programs Adding a Stim Set or a Burst Pulse to a Program Using the MultiSteering Programming Feature Creating a Stimulation Map Using the Dynamic MultiStim Programming Feature Viewing the Test Log Measuring Impedance Modifying IPG Modes Saving a Program Using the Active Balancing Programming Feature Downloading Programs Overriding the Usage Range for Amplitude Managing Patient Records Buttons and Icons on the Patient Database Screens Accessing the Patient Database Changing the Password for the Patient Database Adding a Patient to the Database Editing a Patient s Information Deleting a Patient From the Database Combining Patient Data Merging and Copying Patient Databases Exporting Patient Records Restoring a Database ii Rapid Programmer System Clinician s Manual

5 Printing Types of Printable Reports Printing a Neurostimulation Record Printing the Patient List Printing a Lead Diagnostics Report Cleaning and Maintaining the Rapid Programmer System Handling the Programmer Cleaning the Programmer Storing and Transporting the Programmer Troubleshooting Troubleshooting Chart Performing a Soft Reset Reinstalling the Software Copying Log Files Returning the Rapid Programmer System for Service Service and Ordering Information Technical Support Ordering Information Appendix A: Printable Reports of the Rapid Programmer System Neurostimulation Record Patient List Lead Diagnostics Report Appendix B: Specifications Appendix C: Regulatory Statements Statement of FCC Compliance Declaration of Conformity (Industry Canada) Notice to Users of Radio and Television Disposal Guidelines for Battery-Powered Devices Appendix D: Symbols and Definitions Appendix E: Electromagnetic Compatibility Guidelines Index Rapid Programmer System Clinician s Manual iii

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7 Prescription and Safety Information Read this section for important prescription and safety information. NOTE: The information contained in this manual is provided solely for operating the Rapid Programmer system and must not be considered all-inclusive with respect to a St. Jude Medical neurostimulation system or other system components. Before using the Rapid Programmer system to program a patient, you should thoroughly read this manual and become familiar with using the components of the neurostimulation systems that the Rapid Programmer system supports. Intended Use The Rapid Programmer system is intended to help clinicians determine the best performance of a neurostimulation system by leading the patient through a series of parameter combinations for the neurostimulation system and recording the stimulation effects. The system is intended to be used for programming while it is disconnected from an external power source. Prescription Information Refer to the clinician s manual for the appropriate device to get specific instructions and other important information, including indications for use, contraindications, warnings, precautions, and adverse effects related to those components. Warnings The following warnings apply to the programming system: Explosive or flammable gases. Do not use programming devices in an environment where explosive or flammable gas vapors are present. The operation of programming devices could cause these vapors to ignite resulting in severe burns, other injuries, or death. Battery warning. This device contains a lithium ion rechargeable battery. To reduce the risk of fire or burns, do not disassemble, crush, puncture, short external contacts on, or dispose of the battery in fire or water. Do not insert metal objects into the charging or communications ports of the device. This can short-circuit the battery and result in danger. Replace the battery with only an authorized spare. A risk of explosion is possible if the battery is replaced by an incorrect battery type. Keep battery packs away from children. Rapid Programmer System Clinician s Manual 1

8 Case damage. If the programmer case is pierced or ruptured, injury could result from exposure to the battery chemicals or sharp edges. Inspect programmer integrity before use. Do not use if the device shows signs of damage. Return to St. Jude Medical for evaluation. Shock hazards. To prevent electrical shock, (1) Use this device to program a patient programmer or a trial system only when it is operating under battery power and is not connected to a power outlet or to any external accessories; (2) do not expose the system to rain or moisture; and (3) do not open the outer case of the system or the system s power supply. No part of this product is serviceable by the user. Refer servicing to qualified personnel only. 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. Precautions The following precautions apply to the programming system: Nonsterile device. The medical device system comprised of the programmer and other St. Jude Medical devices as specified in this document must be used in accordance with IEC for patient programming. This device is a nonsterile device and must be kept out of the sterile field (patient environment). Clinician training. Clinicians should be familiar with neurostimulation therapy and be experienced diagnosing and treating the indication for which the neurostimulation system components are being used. Device inspection. Before operating the system each time, inspect the device and all its components for mechanical and electrical integrity. Avoid using the system if the device or its components are damaged. Return damaged components to St. Jude Medical for evaluation. Position the power cord carefully. Position the power adapter so that it will not be walked on, tripped over, or pinched by items placed upon or against it. Pay particular attention to the plug, electrical outlet, and the point where the power adapter exits the product. 2 Rapid Programmer System Clinician s Manual

9 Unplug the power cord properly. When unplugging the power adapter from an electrical outlet, do not pull on cords and cables. Grasp and pull from the plug. Avoid hot areas. The product should be placed away from heat sources such as radiators, heat registers, stoves, and other products that produce heat. If the product shows noticeable signs of damage due to overheating, do not use it. Return damaged components to St. Jude Medical for evaluation. Avoid blocking the vents. Slots and other openings are provided for ventilation. To prevent overheating, do not obstruct vents. Using the device on a soft surface, such as a pillow, blanket, rug, or thick clothing may block airflow. Battery inspection. Periodically before using the programmer, check the programmer battery for bulging due to aging or other damage. Avoid using the programmer if the battery is deformed. Device modification. To prevent damage to the system, do not modify the device in any way. Patient contact. Avoid making contact with the patient when using the device. Electromagnetic interference (EMI). Certain commercial electrical equipment (e.g., some computer monitors, arc welders, induction furnaces, and resistance welders), communication equipment (e.g., microwave transmitters, linear power amplifiers, and high-power amateur transmitters), and high-voltage power lines may generate sufficient EMI to interfere with the operation of a neurostimulation system if they are approached too closely. Wireless use restrictions. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on. Rapid Programmer System Clinician s Manual 3

10 Device Compatibility Guidelines Only the following St. Jude Medical components may be used with the Rapid Programmer system: Patient Programmer, Models 3850, 3851, 3852, 3853, 3855, and 3856 MTS system Bluetooth printer, Model 3823 Rapid Programmer system accessories (see the Ordering Information section) No other components may be connected to the Rapid Programmer system. Use only St. Jude Medical-approved accessories with the Rapid Programmer system. Use only the power adapters and power supply that are supplied with the system or from St. Jude Medical as a replacement. 4 Rapid Programmer System Clinician s Manual

11 Product Description The Rapid Programmer system interfaces with St. Jude Medical neurostimulation systems and is intended to be used to noninvasively control device parameters. The Rapid Programmer system software is installed only on a St. Jude Medical-approved PDA. Users interface with the software and enter data using a stylus. Contents of Package The Rapid Programmer system (Model 3834) comes with the following items. Table 1: Package contents of the Rapid Programmer system Item Description Rapid Programmer Interfaces with St. Jude Medical (Model 3834) neurostimulation systems and allows you to noninvasively control device parameters Power adapter (included with Model 3834) Allows you to use a wall outlet as a power source to charge the Rapid Programmer system MTS communication cable (Model 1273) Connects an MTS system to the CF card cable IrDA communication cable (Model 1280) Connects a patient programmer to the CF card cable AAA batteries (included with Model 1280) Provide power for the IrDA communication cable Rapid Programmer System Clinician s Manual 5

12 Item Compact flash to DB9 cable (CF card cable, Model 1291) Description Connects the Rapid Programmer system to the MTS communication cable or IrDA communication cable Stylus for RP Model 3834 (Model 1626) Allows you to operate the touch screen of the Rapid Programmer system Extended battery for RP Model 3834 (Model 1629) Provides power for the Rapid Programmer system Rapid Programmer database card (Model 3805) Stores patient data and Rapid Programmer system information 6 Rapid Programmer System Clinician s Manual

13 Parts of the Rapid Programmer System The following images provide information about the parts of the Rapid Programmer system: Legend: 1. Power button 2. Light sensor 3. Power and Bluetooth LEDs 4. Touch screen 5. Inactive button 6. Inactive button 7. Inactive button 8. Inactive button 9. Inactive button Figure 1: Front of the Rapid Programmer system Legend: 1. Back speaker 2. Battery compartment cover 1 2 Figure 2: Back of the Rapid Programmer system Rapid Programmer System Clinician s Manual 7

14 1 2 Legend: 1. CF card slot 2. Database card slot 3. Not used 4. AC 24-pin adapter port 5. Charger port 6. Not used Figure 3: Top and bottom of the Rapid Programmer system 2 Legend: 1. Inactive button 2. Stylus 3. Soft reset button 1 3 Figure 4: Sides of the Rapid Programmer system 8 Rapid Programmer System Clinician s Manual

15 Setting Up the Rapid Programmer System The following sections provide instructions for setting up the Rapid Programmer system. Inserting the System Battery When you receive your system, the programmer s rechargeable lithium ion battery is removed and needs to be inserted. To insert the programmer battery, follow these steps: 1. Using your thumbnail, press in at the notch on the side of the battery compartment cover. 2. Pull up to remove the cover from the back of the programmer. 2 1 Figure 5: Sequence for removing the battery compartment cover Rapid Programmer System Clinician s Manual 9

16 3. Hold the end of the battery release ribbon outside the battery compartment, and insert the new battery by aligning the pins on the bottom of the battery with the housing in the battery compartment. Ensure that the ribbon is exposed after pressing the battery into place. Figure 6: Inserting the battery 4. Insert the left side of the battery compartment cover into the notches in the left side of the battery compartment, and press the cover closed. Charging the System Before you use the system for the first time, you need to fully charge the system. You can charge the system using either the power adapter or the car charger (sold separately). NOTE: A solid amber light on the front of the programmer indicates that the battery is charging. When the battery is fully charged, the light turns solid green. WARNING: Do not program a patient while the system is being charged. 10 Rapid Programmer System Clinician s Manual

17 Using the Power Adapter To charge the system using the power adapter, follow these steps: 1. Insert the appropriate plug accessory into the slot on the power adapter. 2. Plug the power adapter into an electrical outlet. 3. Insert the other end of the power adapter into the 24-pin power adapter port on the bottom of the programmer Figure 7: Sequence for connecting the power adapter for charging Using the Car Charger To charge the system using the car charger, follow these steps: 1. Assemble the car charger by connecting the cable to the socket plug. 2. Plug the car charger into the automobile s cigarette lighter socket. 3. Insert the other end of the car charger into the corresponding charger port on the bottom of the programmer. Turning the System On and Off To turn the system on or off, press the power button on the upper right corner on the front of the programmer. Rapid Programmer System Clinician s Manual 11

18 Connecting a Patient Programmer To connect a patient programmer to the Rapid Programmer system, follow these steps: NOTE: To keep the CF card connected to its cable, handle all cables with care while inserting and connecting them. CAUTION: To avoid damaging the IrDA communication cable, do not remove the ribbon from the battery compartment end of the IrDA communication cable. 1. If necessary, remove the protective plastic card from the CF card slot on the top of the Rapid Programmer system. 2. Insert the CF card cable into the Rapid Programmer system (see the following figure, left). Ensure the proper orientation of the card; the FRONT label on the CF card should face the front the programmer. 3. If needed, insert three AAA batteries (included) into the battery compartment end of the IrDA cable. 4. Connect the 9-pin connection end of IrDA cable to the CF card cable, and then connect the battery compartment end of the IrDA cable to the patient programmer (see the following figure, right). Figure 8: Connecting the CF card cable Figure 9: Connecting the IrDA cable 12 Rapid Programmer System Clinician s Manual

19 Connecting an MTS System To connect an MTS system to the Rapid Programmer system, follow these steps: NOTE: To keep the CF card connected to its cable, handle all cables with care while inserting and connecting them. 1. If necessary, remove the protective plastic card from the CF card slot on the top of the Rapid Programmer system. 2. Insert the CF card cable into the Rapid Programmer system (see the previous figure, left). Ensure the proper orientation of the card; the FRONT label on the CF card should face the front of the programmer. 3. Open the communication port door on the MTS system. NOTE: You may need to unlock the communication port door before connecting the communication cable to the MTS system. To unlock the communication port door, insert the stylus or a similar object into the release port of the MTS system, and slide the door until the communication port is exposed. After you are finished using the MTS system, close and lock the communication port door. 4. Insert the MTS communication cable plug into the MTS communication port. Legend: 1. Communication port 2. Communication port door 3. Release port Figure 10: Plugging the MTS communication cable into the communication port Rapid Programmer System Clinician s Manual 13

20 5. Connect the 9-pin connection end of the MTS communication cable to the CF card cable. Figure 11: Connecting the MTS communication cable to the CF card cable 14 Rapid Programmer System Clinician s Manual

21 Inserting a Database Card To insert a database card into the programmer, follow these steps: 1. If necessary, remove the protective plastic card from the database card slot. 2. With the database card label facing toward the front of the programmer and the gold pins facing toward the back, insert the card into the database card slot and press until the card is seated flush with the top edge of the programmer. CAUTION: To avoid damaging the system, insert the database card with the label facing toward the front of the programmer. Figure 12: Inserting the database card Rapid Programmer System Clinician s Manual 15

22 Removing a Database Card To remove a database card from the programmer, follow these steps: 1. Ensure that the system is turned off or that you are on the Main Menu screen. NOTE: The system database can be corrupted if a user removes the database card while the programmer is writing to the card. If the database gets corrupted, all data will be lost. 2. Push down slightly on the database card and release to unseat it. 3. When the card pops up, pull it from the database card slot. Figure 13: Removing the database card 16 Rapid Programmer System Clinician s Manual

23 Replacing the System Battery If the system battery reaches the end of its life, you will need to replace the battery with a St. Jude Medical-approved spare. To replace the system battery, follow these steps: 1. Ensure that the system is turned off. 2. Using your thumbnail, press in at the notch on the side of the battery compartment cover and then pull up to remove the cover from the back of the programmer. 3. To release the battery, gently pull the ribbon straight out from the programmer. Figure 14: Releasing the battery 4. Remove the battery. 5. Hold the end of the battery release ribbon outside the battery compartment, and insert the new battery by aligning the pins on the bottom of the battery with the housing in the battery compartment. Ensure that the ribbon is exposed after pressing the battery into place. 6. Insert the left side of the battery compartment cover into the notches in the left side of the battery compartment, and press the cover closed. Rapid Programmer System Clinician s Manual 17

24 Getting Started This section contains information about icons and buttons and provides instructions for performing basic functions, such as adjusting programmer settings. Navigating the Main Menu Screen When you turn on the Rapid Programmer system, the Main Menu screen appears. From the Main Menu screen, you can access the different user screens and menus. The following table provides definitions of the buttons and menu options that are available on the Main Menu screen. Table 2: Buttons and menu options on the Main Menu screen Button or Menu Option Definition New Session enables you to start a new programming session with a patient. Last Session allows you to resume the last programming session. Intra-Op allows you to perform intraoperative testing. During intraoperative testing, programs will not be uploaded from or downloaded to the patient programmer or MTS system. Print Last Session allows you to print the last programming session. Patient List displays patient records. Tools Settings View Demo enables you to see a demonstration of the software without having a device connected to the Rapid Programmer system. Within the Tools menu, you can restore the database, copy log files, reset the Rapid Programmer system, and reinstall the Rapid Programmer system software. Within the Settings menu, you can change preferences for the following settings: backlight, brightness, clock, power, regional, screen, and volume. 18 Rapid Programmer System Clinician s Manual

25 Adjusting Backlight Settings While you are working with the programmer, backlighting illuminates the screen. To help preserve the battery capacity, you can set the backlight to turn off after a period of inactivity. You can adjust this setting for the programmer when it operates on battery power or on external power. To adjust backlight settings, follow these steps: 1. On the Main Menu screen, tap Settings, then Backlight. The Backlight screen appears. Figure 15: The Backlight screen 2. Do one of the following: To change settings for battery power, tap the Battery Power tab. To change settings for external power, tap the External Power tab. 3. To turn off the backlight after a period of inactivity, ensure that the first check box is selected, and then tap the list to select the amount of time before the backlight turns off. 4. Adjust other settings as desired by tapping the appropriate check boxes and lists. Rapid Programmer System Clinician s Manual 19

26 Adjusting Screen Brightness You can adjust the level of brightness of the backlighting on the screen for the programmer when it operates on battery power and external power. A lower brightness level help preserve battery capacity when operating the programmer on battery power. To adjust the screen brightness, follow these steps: 1. On the Main Menu screen, tap Settings, then Brightness. The Brightness Level screen appears. Figure 16: The Brightness Level screen 2. Tap and drag the desired slider to adjust the brightness level for battery power or external power. NOTE: A light sensor on the front of the programmer detects the environmental light level and automatically adjusts the screen brightness in a small range based on the current setting. 20 Rapid Programmer System Clinician s Manual

27 Setting the Time and Date The time and date appear on printable reports. To set the time and date for your home location or a visited location, follow these steps: 1. On the Main Menu screen, tap Settings, then Clock. The Clocks & Alarms screen appears. Figure 17: The Clocks & Alarms screen NOTE: When you first start using the programmer or if you remove the programmer battery, you may be prompted to set the time and date, which means that the Clocks & Alarms screen automatically opens. 2. Do one of the following: To set the time and date for your home location, tap the Home option button. To set the time and date for a visited location, tap the Visiting option button. Rapid Programmer System Clinician s Manual 21

28 3. To adjust the time zone, tap arrow beside the time zone box and select the correct zone from the list that appears. 4. To adjust the time, tap the hour, minute, second, or morning or afternoon designation, and then tap the increase and decrease buttons to adjust the value. 5. To adjust the date, tap the arrow beside the date box to expand a calendar, and do any of the following: To adjust the month, tap the name of the month and select the correct month from the list that appears. To adjust the year, tap the year and then tap the increase and decrease buttons. To adjust the day, tap the correct day in the calendar. 6. Tap the Home or Visiting option button to select the time that you want to use. Checking the Programmer Battery Status To check the status of the programmer battery, follow these steps: 1. On the Main Menu screen, tap Settings, then Power. The Power screen appears. 2. Ensure that the Battery tab is selected to view the amount of power remaining in the battery. Figure 18: The Power screen showing battery power information 22 Rapid Programmer System Clinician s Manual

29 Adjusting the Automatic Shutoff Settings You can set the programmer to turn off after a period of inactivity, and you can adjust this setting for the programmer when it operates on battery power or on external power. To adjust these automatic shutoff settings, follow these steps: 1. On the Main Menu screen, tap Settings, then Power. The Power screen appears. 2. Tap the Advanced tab. Figure 19: The Power screen showing automatic shutoff settings 3. To set the automatic shutoff time on battery power, ensure that the battery power check box is selected, and then tap the list to select the amount of time before the programmer turns off. 4. To set the automatic shutoff time for external power, tap the external power check box, and then tap the list to select the amount of time before the programmer turns off. Rapid Programmer System Clinician s Manual 23

30 Calibrating the Touch Screen The touch screen display will occasionally require calibration to increase the accuracy of screen taps. To calibrate the touch screen, do the following action: On the Main Menu screen, tap Settings, then Screen. The align screen screen appears. Follow all on-screen instructions carefully, and ensure that the stylus touches the center of the target graphic for proper calibration. NOTE: The Main Menu screen appears automatically after you are finished. Figure 20: The align screen screen 24 Rapid Programmer System Clinician s Manual

31 Adjusting the Volume To adjust the volume of the programmer, follow these steps: 1. On the Main Menu screen, tap Settings, then Volume. The Sound screen appears. 2. Tap and drag the slider to the desired volume. Figure 21: The Sound screen Rapid Programmer System Clinician s Manual 25

32 Starting the Demo The demo feature allows you to practice creating a program for systems without having an actual patient or device. To start a demo session, follow these steps: 1. From the Main Menu screen, tap. The Demo Session dialog box appears. Figure 22: The Demo Session dialog box 2. In the Select a demo list, tap the type of device that will be represented in the demo. 3. Tap OK. The demo simulates a postoperative programming session. Refer to sections in Intraoperative and Postoperative Programming for instructions on how to select lead configurations and program in demo mode. NOTE: While you can perform the demo with any of the available lead configurations, only specific lead configurations contain default programs, which have demonstration program parameters and test log data. If you select a configuration other than one of these specific lead configurations, a Lead Change message appears. When you tap OK in this message, all the default programs are deleted for the demo session. 26 Rapid Programmer System Clinician s Manual

33 Intraoperative and Postoperative Programming This section provides instructions and information about intraoperative and postoperative testing and programming. Before programming with a patient, you may want to view the demo to familiarize yourself with the programmer functions (refer to Starting the Demo ). NOTE: To keep the CF card connected to its cable, handle all cables with care while programming. Buttons and Icons on the Programming Screens The following table provides definitions for buttons and icons that you may encounter while testing and programming. NOTE: Not all buttons or icons will be available on all screens. You can also access the definitions of on-screen buttons and icons by tapping the help icon ( ) in the upper righthand corner of many of the screens. Table 3: Buttons and icons on the programming screens Button or Icon Definition Access definitions of on-screen buttons and icons. Turn the on-screen keyboard on or off. Add a new program. Copy the selected program. Edit the selected program. Delete the selected program or stimset on the Programs screen. Print a report or list. Balance the selected program. Automatically return the amplitude to the programmed perception value while steering stimulation. (When this feature is active, the icon on this button is blue.) Rapid Programmer System Clinician s Manual 27

34 Button or Icon Definition Use the MultiSteering programming feature to steer the electrical field up. Use the MultiSteering programming feature to steer the electrical field down. Use the MultiSteering programming feature to steer the electrical field left. Use the MultiSteering programming feature to steer the electrical field right. Shift the electrode polarities up. Shift the electrode polarities down. Increase the value of a parameter (Increase button). Decrease the value of a parameter (Decrease button). Change the polarity of the IPG can. Set the target, comfort, or perception amplitude to the current amplitude level. Ramp the current amplitude to the target, comfort, or perception level. Map where the patient feels stimulation. Stop stimulation immediately for all active stim sets. Add a new stimset or burst pulse to the program. Delete a stimset or burst pulse from the program. Turn the selected stimset on. Turn the selected stimset off. View the test log. 28 Rapid Programmer System Clinician s Manual

35 Button or Icon Definition Check impedance on the lead configuration. Edit the timing and magnet mode of the program. Activate or inactivate BurstDR stimulation programming. (When this feature is active, the icon on this button is blue.) Starting an Intraoperative Testing Session To start intraoperative testing, follow these steps: 1. Ensure the system is connected to the patient programmer or MTS unit to be programmed. NOTE: If testing using a patient programmer, ensure that the patient programmer is communicating with the generator before starting the testing session. For instructions on communicating with the generator, refer to the clinician s manual or user s guide for the appropriate system. NOTE: Once the system has successfully established communication with the device to be programmed, the screen of the patient programmer or MTS unit displays COMPUTER COMMUNICATIONS. 2. On the Main Menu screen, tap. The Select Lead dialog box appears. Rapid Programmer System Clinician s Manual 29

36 3. In the Select a lead configuration for intra-operative testing list, tap the appropriate lead configuration. Figure 23: The Select Lead dialog box 4. Tap OK. The Testing screen appears. Figure 24: The intraoperative testing screen 30 Rapid Programmer System Clinician s Manual

37 5. Perform intraoperative testing. To enhance the speed of an intraoperative testing session, the testing functions are limited to the following. Refer to the corresponding sections in this manual for instructions on performing these functions. Setting electrode polarities Adjusting amplitude and amplitude step size Adjusting frequency and pulse width Measuring impedance Using the MultiSteering programming feature Rapid Programmer System Clinician s Manual 31

38 Starting a New Programming Session or Resuming the Previous Session To start a new programming session or resume the previous session, follow these steps: 1. Ensure the system is connected to the patient programmer or MTS unit to be programmed. NOTE: Before programming a patient, ensure you are not in demo mode. NOTE: If programming using a patient programmer, ensure that the patient programmer is communicating with the generator before starting the programming session. For instructions on communicating with the generator refer to the clinician s manual or user s guide for the appropriate system. NOTE: Once the system has successfully established communication with the device to be programmed, the screen of the patient programmer or MTS unit displays COMPUTER COMMUNICATIONS. 2. On the Main Menu screen, tap one of the following as appropriate. Begin programming a new patient or a different device, or program the same device and discard the unsaved programming information from the previous session. Return to the last programming session. NOTE: Do not use this option when using the system to program a different patient or if a change has been made to the patient programmer or MTS unit while disconnected from the system. 3. If a message appears stating, All information from the prior session will be deleted. Continue?, tap OK. 4. When using the MTS system, if a message appears stating, Is this a new patient?, tap Yes to delete all the programs on the MTS system or tap No to keep the existing programs. The Uploading Programs screen and then the Programs screen appears. The Programs screen displays the Device Info tab. NOTE: When the Is this a new patient? message appears, if you tap Yes by mistake, you can prevent the programs on the MTS system from being deleted by tapping Cancel Session on the Programs screen. 32 Rapid Programmer System Clinician s Manual

39 Figure 25: The Programs screen 5. If needed, in the Device Info tab, tap (edit) next to the patient s name. The Patient Details screen appears, which displays the Patient Info and Comments tabs. NOTE: Tap in the bottom of the screen to display the on-screen keyboard. Tap the 123 button in the upper left corner of the keyboard to switch between numbers and letters. Figure 26: The Patient Details screen Rapid Programmer System Clinician s Manual 33

40 6. In the Patient Info and Comments tabs, use the on-screen keyboard to enter information in the boxes as needed. 7. When finished, tap Save. Selecting the Lead Configuration To select the patient s lead configuration for postoperative programming, follow these steps: On the Device Info tab on the Programs screen, select the patient s lead configuration from the Lead Configuration list. NOTE: If single lead is inserted into the top header of a dual-header generator, you should not select a single lead configuration. Instead select the dual-lead option (indicated by x2 ) of the lead you want to program. Program the lead numbered 9 to 16 (for an Octrode lead) or 5 to 8 (for a Quattrode lead). Resetting the Hours Used for the MTS System When programming the MTS system for a new patient, you can reset the usage counter to zero. To reset the hours used, follow these steps: 1. On the Device Info tab on the Programs screen, tap (reset). 2. When the Confirm Reset message appears, tap OK. Figure 27: The Confirm Reset message 34 Rapid Programmer System Clinician s Manual

41 Adding a New Program To add a new program, follow these steps: 1. On the Programs tab on the Programs screen, tap. The Testing screen appears. 2. Set the desired parameters Figure 28: Features of the Testing screen Copying a Selected Program To copy a program, follow these steps: Legend: 1. Shifts the electrode polarities or the electrical field 2. Automatically returns the amplitude to the programmed perception level when steering stimulation 3. Adds a new stim set to the program 4. Deletes the current stimset 5. Switches to BurstDR stimulation programming mode 6. Shows the test log 7. Checks impedance on the electrode configuration 8. Edits the timing and magnet mode of the program 9. Selects the stim set for testing. 10. Turns the stim set on or off 11. Sets the comfort amplitude to the current level. 12. Ramps the current amplitude to the comfort level 13. Sets the perception amplitude to the current level 14. Ramps the current amplitude to the perception level 15. Maps the location of perceived stimulation 16. Stops stimulation on all stim sets 1. On the Programs tab on the Programs screen, select the program from the list that you want to copy. 2. Tap. The duplicated program appears as the next available program number. Rapid Programmer System Clinician s Manual 35

42 Editing a Selected Program To edit a program, follow these steps: 1. On the Programs tab on the Programs screen, select the program from the list that you want to edit. 2. Tap. The Testing screen appears. 3. Edit the desired parameters. Deleting a Selected Program, Stim Set, or Burst Pulse To delete a program or stim set, follow these steps: 1. On the Programs tab of the Programs screen, select the program or stim set from the list that you want to delete. 2. Tap. The Confirm Delete message appears. 3. Tap OK. NOTE: If you select and delete the pulses of a BurstDR stimulation program on the Programs screen, you will delete the entire program. NOTE: You can also delete a stim set or a burst pulse while viewing it on the Testing screen. While on the Testing screen, tap the number of the stim set or burst pulse you want to delete, tap, and follow the on-screen prompts. Figure 29: The Confirm Delete message 36 Rapid Programmer System Clinician s Manual

43 Switching Between Tonic Mode and BurstDR Stimulation Mode Some systems allow you to create and modify two types of programs: BurstDR stimulation 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 group. This type of program is available only on some systems that the Rapid Programmer system supports. Tonic program. A program where the stimulation frequency consists of a single, repeating pulse. This program type is available on all neurostimulation systems that the Rapid Programmer system supports. If the system you are programming is capable of BurstDR stimulation, you can switch to BurstDR stimulation programming mode on the Testing screen. NOTE: When creating a new program, you start programming in tonic programming mode by default. NOTE: When you switch between BurstDR stimulation mode and tonic mode, all programmed values reset to default except the electrode configuration. To switch between tonic mode and BurstDR stimulation mode, follow these steps: 1. On the Testing screen, tap. When BurstDR stimulation mode is active, the icon turns blue, the screen background turns blue, and the Testing screen displays the features for BurstDR stimulation programming (see the following figure). 2. To return to tonic mode, tap. When BurstDR stimulation mode is inactive, the icon turns gray, the screen background turns white, and the Testing screen displays the features for tonic programming. Rapid Programmer System Clinician s Manual 37

44 Figure 30: Features of the Testing screen in BurstDR stimulation mode 4 6 Legend: 1. Displays the overall frequency of the BurstDR stimulation program 2. Displays the frequency of each burst pulse in a pulse group 3. Sets the target amplitude to the current level 4. Ramps the target amplitude to the target level 5. Maps the location of perceived stimulation 6. Stops stimulation on all stim sets 7. Adds a burst pulse to the pulse group 8. Deletes a burst pulse 9. Displays the number of burst pulses 10. Turns stimulation on or off 11. Inactivates BurstDR stimulation programming mode 12. Checks impedance on the electrode configuration 13. Edits the timing and magnet mode of the program Configuring Electrode Polarities Individual electrodes on a lead can be set to positive (anode), negative (cathode), or neutral. The IPG (also called a can ) also may be configured as positive (anode) or neutral. NOTE: The IPG can be used as an anode only for tonic programs. NOTE: When the IPG is used as an anode, lead polarities can be only negative or neutral. All lead polarities that are configured as anodes are automatically set to neutral. NOTE: If you manually change polarities while stimulation is active, stimulation turns off. If you manually change polarities after you have set values for perception and comfort amplitude, a Reset Parameters message appears. If you tap OK, the perception and comfort amplitude values reset to zero and the stimulation map is erased. To configure electrode polarities, follow these steps: 1. On the Testing screen, tap a numbered electrode button on the lead diagram. The first tap changes a neutral electrode to a negative polarity (cathode); the second tap changes the electrode to a positive polarity (anode); and the third tap returns the electrode to a neutral state. 38 Rapid Programmer System Clinician s Manual

45 2. To use the IPG as an anode, tap in the lower left of the Testing screen. This icon turns red and shows a plus sign when activated. To return the IPG to a neutral state, tap. Adjusting Pulse Width During intraoperative testing and postoperative testing for new programs, the PW (pulse width ) box on the Testing screen displays default values, which are determined by the system type and programming mode (tonic or BurstDR stimulation). To change values for pulse width, do either of the following: Tap the Increase/Decrease buttons next to the PW box. Tap the PW box, and then tap a value in the drop-down list. Adjusting Frequency for Tonic Programs During intraoperative testing and postoperative testing for new tonic programs, the Freq (frequency ) box on the Testing screen displays system default values To change values for frequency, do either of the following: Tap the Increase/Decrease buttons next to the Freq box. Tap the Freq box, and then tap a value in the drop-down list. Adjusting Frequency for BurstDR Stimulation Programs BurstDR stimulation programs have two frequency values that you can set: the overall frequency (Burst Rate) and the frequency of each individual pulse in a pulse group (Intra-burst). During postoperative testing for new BurstDR stimulation programs, the Burst Rate and Intra-burst boxes on the Testing screen display system default values. To change the frequency values for a BurstDR stimulation program, do either of the following: Tap the Increase/Decrease buttons next to the respective box. Tap the respective box, and then tap a value in the drop-down list. Rapid Programmer System Clinician s Manual 39

46 Adjusting Amplitude and Step Size On the Testing screen, you can adjust amplitude and step size. Amplitude is the strength of the electrical pulse that is delivered from the lead. Step size is the increment at which amplitude will change when you adjust amplitude during programming. Programs that use a higher amplitude setting deplete the neurostimulation system battery faster. NOTE: At any time during testing, you can immediately stop the patient s stimulation by tapping. NOTE: When the generator reaches its energy limit, the Energy Limit dialog box appears. To reduce the energy output of the generator, tap ok and follow the on-screen suggestions. NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow. To reduce the output of the generator, try reducing the amplitude or pulse width or try setting additional anodes or cathodes on the lead configuration. To adjust amplitude, follow these steps: 1. If stimulation is off, tap the Increase button next to the Amp box to start stimulation. 2. To change the step size, tap the Increase/Decrease buttons next to the Step box, or tap the Step box and then tap a value in the drop-down list. 3. Tap the Increase/Decrease buttons next to the Amp box to increase or decrease stimulation accordingly. Setting Perception and Comfort Amplitudes for Tonic Programs To complete a tonic program during postoperative programming, you must set values for perception (Perc) and comfort (Comf) amplitudes for each stim set. The perception amplitude is the value at which the patient first feels stimulation. The comfort amplitude is the value at which the stimulation feels comfortable to the patient. NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow. To reduce the output of the generator, try reducing the amplitude or pulse width or try setting additional anodes or cathodes on the lead configuration. NOTE: During programming, if you change electrode polarities after you have set the values for perception and comfort amplitude, the perception and comfort amplitude values will reset to zero. 40 Rapid Programmer System Clinician s Manual

47 NOTE: Once you have set the comfort and perception amplitudes, you can tap next to the Comf and Perc boxes to ramp the amplitude to the respective comfort or perception value. To set a patient s perception and comfort amplitudes, follow these steps: 1. Tap the Increase/Decrease buttons next to the Amp box to reach the patient s perception amplitude. 2. To set the perception amplitude, tap next to the Perc box. 3. Tap the Increase/Decrease buttons next to the Amp box to reach the patient s comfort amplitude. 4. To set the comfort amplitude, tap next to the Comf box. Setting the Target Amplitude for BurstDR Stimulation Programs To complete a BurstDR stimulation program during postoperative programming, you must set the value for the target amplitude. The target amplitude is the value at which stimulation feels comfortable to the patient. NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow. To reduce the output of the generator, try reducing the amplitude or pulse width or try setting additional anodes or cathodes on the lead configuration. NOTE: During programming, if you change electrode polarities after you have set the value for target amplitude, the target amplitude value will reset to zero. NOTE: Once you have set the target amplitude, you can tap ramp the amplitude to the target value. next to the Target box to To set a patient s target amplitude, follow these steps: 1. Tap the Increase/Decrease buttons next to the Amp box to reach the patient s target amplitude. 2. Tap next to the Target box. Adding a Stim Set or a Burst Pulse to a Program To add another stim set to a tonic program or another burst pulse to a BurstDR stimulaton program, follow these steps: 1. On the Testing screen, tap. 2. Set the electrode polarities and other parameters as needed. Rapid Programmer System Clinician s Manual 41

48 Using the MultiSteering Programming Feature The MultiSteering programming feature provides a simplified method for shaping and fine-tuning the electrical field in real time. During testing, certain electrode combinations can be shifted while stimulation remains active. NOTE: This programming feature is available only for tonic programs. NOTE: When programming dual Octrode leads, you can steer stimulation laterally between the two leads. Confirm that the electrodes on the patient s leads are aligned as they appear on the Testing screen. NOTE: Because some nerve fibers may be more sensitive to electrical fields than others, you should adjust the amplitude to the patient s perception level (Perc) each time before steering to the next combination. NOTE: If you have set the Perc value and the return-to-perception button ( ) is active, the system automatically reduces the amplitude to the perception level each time you steer stimulation. If the button is active, the icon is blue. NOTE: If,,, or appear dimmed, it means that the selected electrode combination cannot be steered in that direction. Try adding or removing polarities until the MultiSteering buttons become active. NOTE: When the generator reaches its output limit, the parameter boxes will turn yellow and MultiSteering programming will be temporarily unavailable. To use MultiSteering programming, reduce the output by adjusting pulse width or amplitude. 42 Rapid Programmer System Clinician s Manual

49 To use the MultiSteering programming feature Tap,,, or to steer the stimulation through a set of optimized electrode combinations designed to incrementally shift the stimulation Legend: 1. Shift up 2. Shift left (dimmed) 3. Shift right 4. Shift down 5. Return the amplitude to the programmed perception value (when active) 5 4 Figure 31: MultiSteering programming buttons available on the Testing screen Creating a Stimulation Map During testing, you can create a stimulation map that shows where the patient feels stimulation with a specific stimulation set for tonic programs or with a pulse group for BurstDR stimulation programs. The stimulation map appears as an icon on the user s patient programmer or MTS unit. Rapid Programmer System Clinician s Manual 43

50 To create a stimulation map, follow these steps: 1. On the Testing screen, tap. A screen appears with a graphic representation of the human body and the Draw option selected. Figure 32: The stimulation map screen 2. Tap the areas on the graphic that correspond to the areas where the patient feels stimulation. The tapped areas are highlighted in green. 3. To remove a highlighted area, tap Erase and then the area on the graphic. 4. To save the stimulation map, tap Done. 44 Rapid Programmer System Clinician s Manual

51 Using the Dynamic MultiStim Programming Feature The Dynamic MultiStim programming feature allows you to actively turn a stim set on or off to assess how well the stim sets work separately and together as a program. NOTE: This programming feature is available only for tonic stimulation programs. NOTE: During Dynamic MultiStim program ming, all stim sets must have the same frequency. If you change frequency in one stim set, frequency automatically changes in the program s other stim sets. NOTE: When you add a stim set, the amplitude of all the stim sets returns to zero. The following list describes the stim set buttons used for Dynamic MultiStim programming : 1 When the number of a stim set is blue, you are viewing that stim set. Tap the number to select the stim set and adjust that stim set s settings. When the amplitude is more than zero (active) for that stim set, the Stim Set button is on (green). If stimulation is off, tap the Stim Set button to ramp the amplitude to the last value that was reached for the stim set during the same testing session. When amplitude is zero for that stim set, the Stim Set button is off. If stimulation is more than zero (active) for a stim set, tap the Stim Set button to turn off stimulation. Rapid Programmer System Clinician s Manual 45

52 Legend: 1. Stim set selected 2. Stim set button on 3. Stim set button off Figure 33: Buttons for Dynamic MultiStim programming 46 Rapid Programmer System Clinician s Manual

53 Viewing the Test Log The test log allows you to view stim sets that have been tested on the patient and to add or replace them within the current program. NOTE: The test log is available only for tonic stimulation programs. NOTE: Test log data is only kept within a single programming session. If you start a new session, the test log contains only the stim sets that were uploaded from the device. NOTE: On the Test Log screen (see the following figure), if you select the Show valid stimsets only check box, the test log will show only the stim sets that are compatible with the present program. For program compatibility, see the clinician s manual for the appropriate device. To view the test log, do either of the following: From the Testing screen, tap. From the Programs tab on the Programs screen, select the desired stim set from the list, and tap. Figure 34: The Test Log screen Rapid Programmer System Clinician s Manual 47

54 To Add a Stim Set From the Test Log You can select a stim set from the Test Log screen to add to the current program. NOTE: To be able to add a stim set to an existing program, the parameters of the program must match the device s capabilities and the program must not contain its maximum number of stim sets, which is determined by the device type. If your parameters are outside of acceptable ranges for the device, an error message appears. To add a stim set from the test log, follow these steps: 1. On the Test Log screen, tap the Add tab. 2. Select a stim set from the list. 3. Tap Add. To Replace a Stim Set From the Test Log You can also replace the current stim set with a selected stim set from the Test Log screen. To replace a stim set from the test log, follow these steps: 1. On the Test Log screen, tap the Replace tab. 2. Select a stim set from list. 3. Tap Replace. Measuring Impedance During testing, you may want to periodically measure the impedance on the electrode array as a diagnostic tool to ensure that current is flowing through the system properly. Impedance measurements may help you troubleshoot issues with the neurostimulation system. NOTE: If the parameter boxes on the Testing screen turn yellow, your impedance measurement will probably be high. See the Troubleshooting section for more information. To measure impedance for the programmed electrode array, follow these steps: 1. On the lower left corner of the Testing screen, tap. The Impedance Results dialog box appears (see the following figure, left). 48 Rapid Programmer System Clinician s Manual

55 2. If the option is available, tap Diagnostics in the Impedance Results dialog box to get diagnostic details for the entire lead configuration. The Diagnostic Summary details the condition and the impedance values for each electrode by number (see the following figure, right). If desired, tap Print to print a lead diagnostics report (see Printing ). Figure 35: The Impedance Results dialog box Figure 36: The Diagnostic Summary screen 3. Refer to the applicable clinician s manual for information on interpreting the results of the impedance measurement. 4. When you are finished, do one of the following to return to the Testing screen: In the Impedance Results dialog box, tap Done. On the Diagnostic Summary screen, tap OK. Rapid Programmer System Clinician s Manual 49

56 Modifying IPG Modes From the Edit Modes screen, you can modify IPG modes by performing the following functions: Set the magnet mode Set the program mode Set the on and off times for cycle and bolus mode s Set the ramp time for continuous and bolus modes To modify IPG modes, follow these steps: 1. On the Testing screen, tap. The Edit Modes screen appears. 2. Modify the settings as desired. The following subsections provide more information about using these settings. 3. When you are finished, tap Save. Figure 37: The Edit Modes screen To Set the Magnet Mode The magnet mode settings control how the IPG responds when it senses a magnet. To set the magnet mode, tap the desired option button: Off, which means the IPG will turn off when it senses a magnet On/Off, which means the IPG will toggle between on and off each time it senses a magnet 50 Rapid Programmer System Clinician s Manual

57 To Set the Ramp Time Ramp time is the approximate number of seconds that the IPG takes when starting stimulation to arrive at the perception amplitude for tonic programs or the target amplitude for BurstDR stimulation programs. Ramp time is saved to the IPG; it is not the ramp time that you use while programming. You can adjust the ramp time for the IPG when it is set to continuous or bolus mode (see the To Set the Program Mode section for more information). The default ramp time is 4 seconds. To change the ramp time, tap the Increase/Decrease buttons next to the Ramp Time box. To Set the Program Mode You can set the stimulation mode of a program. The following table provides definitions of the three program modes that may be available. Table 4: Definitions of IPG Program Modes Mode Continuous Cycle Bolus Definition Stimulation is delivered continuously while the IPG is on and the program is running. Stimulation is on for a programmed amount of time (on time) and off for a programmed amount of time (off time). The cycle alternates between on and off time until the IPG is turned off or the program is stopped. Stimulation is on for a programmed amount of time (on time) and then enters a phase of off time. During the off time phase, stimulation cannot be restarted. After the off time has passed, stimulation must be restarted manually. To set the program mode, follow these steps: 1. Under Program Mode, tap the desired check box. If you tap Bolus or Cycle, the On Time and Off Time timer boxes become available. 2. Tap the Increase/Decrease buttons beside the timer boxes to set the on and off phase times. NOTE: You can set the on and off cycle times to a maximum of 24 hours and a minimum of 5 seconds. NOTE: You can set the on and off bolus times to a maximum of 18 hours and a minimum of 1 second. Rapid Programmer System Clinician s Manual 51

58 Saving a Program During postoperative programming, you must save a program before downloading it. To save the program, tap Save on the Testing screen. NOTE: During intraoperative testing, you do not need to save the program. To exit an intraoperative testing session and return to the Main Menu screen, simply tap Done on the Testing screen. NOTE: If any parameters of a stim set are incomplete for a program, a Stimset Error message appears when you try to save the program. To correct this issue, ensure that you have configured valid electrode polarity combinations and have set values for comfort and perception amplitude on all stim sets. Using the Active Balancing Programming Feature The Active Balancing programming feature allows you to individually adjust the amplitudes of each stim set within a program, which helps balance the feeling of stimulation that is delivered to a patient. NOTE: This programming feature is available only for tonic stimulation programs. To balance a program, follow these steps: 1. On the Programs tab on the Programs screen, select a program from the list. 2. Tap. The Balancing screen appears. 52 Rapid Programmer System Clinician s Manual

59 Figure 38: The Balancing screen 3. Tap the Increase button beside the master amplitude box. The amplitude ramps up to the perception value (Perc). NOTE: To stop stimulation, tap Stop. This button turns off the master amplitude but does not change the slider values. 4. Tap the Increase/Decrease buttons to adjust the master amplitude until the patient indicates that stimulation is comfortable. 5. Tap above or below the slider to increase or decrease the amplitude level of a stim set. NOTE: To reset all sliders to zero, tap Reset. 6. If the program contains more than four stim sets, tap More to display the remaining stim sets, and adjust the stim sets if necessary. 7. Tap Save. Rapid Programmer System Clinician s Manual 53

60 Downloading Programs After completing a programming session, you can download programs to the patient programmer or MTS unit that is communicating with the system. All programs are downloaded at once. To download programs, follow these steps: 1. On the Programs tab of the Programs screen, select the program from the list that will be the active program on the patient programmer or MTS unit. Figure 39: A program selected on the Programs screen 54 Rapid Programmer System Clinician s Manual

61 2. Tap Download, and then tap OK in the Replace Programs message that appears (see the following figure). The Downloading Programs screen appears; and after the programs have been downloaded to the patient programmer or MTS unit, the Main Menu screen appears. NOTE: If downloading programs to an IPG, ensure that the programs have finished downloading before moving the programming wand from over the IPG site. Figure 40: The Replace Programs message 3. To ensure that the device has completed the download process, turn the patient programmer or MTS unit off and then on again. Overriding the Usage Range for Amplitude Before downloading programs, you can override the usage range for amplitude. The Override Usage Range screen allows you to override the tested amplitude range by increasing the maximum tolerable amplitude or decreasing the perception amplitude setting by up to 25 percent without testing stimulation on the patient. NOTE: The feature to override the usage range is available only for tonic stimulation programs. NOTE: If you override the amplitude usage range of a MultiStim program that has been balanced using the Active Balancing programming feature, you may need to rebalance the program (see Using the Active Balancing Programming Feature ). Rapid Programmer System Clinician s Manual 55

62 To override the usage range 1. On the Programs tab of the Programs screen, tap and hold Download for 5 seconds until the Override Usage Range screen appears. Figure 41: The Override Usage Range screen 2. Tap the Increase/Decrease buttons to change the maximum tolerable amplitude and perception amplitude percentages as desired. 3. Select one or more program check boxes to which you want to apply the changes. -OR- Select the Apply to all programs check box to select all check boxes. 4. Tap Download, and then tap OK in the Replace Programs message that appears. The programs are downloaded to the patient s device. 56 Rapid Programmer System Clinician s Manual

63 Managing Patient Records The Rapid Programmer system allows you to manage patient records by adding, editing, or deleting patient data. To manage patient data, ensure that a database card that is compatible with the Rapid Programmer system is inserted. Buttons and Icons on the Patient Database Screens The following table provides definitions for buttons and icons that you may encounter while managing patient records. NOTE: Not all buttons or icons will be available on all screens. You can also access the definitions of on-screen buttons and icons by tapping the help icon ( ) in the upper righthand corner of many of the screens. Table 5: Buttons and icons on the patient database screens Button or Icon Definition Access definitions of on-screen buttons and icons. Turn the on-screen keyboard on or off. Add a new patient. Edit a selected (highlighted) patient. Combine two checked patients into one record. Delete checked patients. Print the patient list (on the Patients screen). Print the programs for the patient (on the Patient Details screen). Export checked patient records to the database card. Rapid Programmer System Clinician s Manual 57

64 Accessing the Patient Database To access the patient database, you must enter a password. Contact Technical Support for the default password related to your software version. Once you have the password, follow these steps: 1. From the Main Menu screen, tap. The Enter Password screen appears. Figure 42: The Enter Password screen displaying the on-screen keyboard 2. If necessary, tap at the bottom of the screen to display the on-screen keyboard. Tap the 123 button in the upper left corner of the keyboard to switch between symbols and letters. 3. Enter the password in the Enter Password box. Passwords can be up to 11 characters. See Changing the Password for Viewing Patients to change the password. NOTE: The password is case sensitive. 58 Rapid Programmer System Clinician s Manual

65 4. Tap OK. The Patients screen appears. You can sort list items by tapping the column heading. 5. If desired, tap to print the patient list (see Printing ). Figure 43: The Patients screen Rapid Programmer System Clinician s Manual 59

66 Changing the Password for the Patient Database To change the password for the patient database, follow these steps: 1. On the Patients screen, tap Database, and then tap Change Password. The Change Password screen appears. 2. Use the on-screen keyboard to fill in the boxes, and tap OK when finished. Figure 44: The Change Password screen 60 Rapid Programmer System Clinician s Manual

67 Adding a Patient to the Database To add a patient to the database, follow these steps: 1. From the Patients screen, tap. The Patient Details screen appears. Figure 45: The Patient Details screen 2. On the Patient Info and Comments tabs, tap a box you want to complete and enter the information using the on-screen keyboard. 3. If desired, tap to print the selected patient s neurostimulation record (see Printing ). 4. Tap Save to save the patient s information and return to the Patients screen. Rapid Programmer System Clinician s Manual 61

68 Editing a Patient s Information To edit a patient s information in the database, follow these steps: 1. From the list on the Patients screen, tap the name of the patient you want to edit. The selected name is highlighted. Figure 46: Highlighting a patient on the Patients screen 2. Tap. The Patient Details screen appears. Figure 47: The Patient Details screen 62 Rapid Programmer System Clinician s Manual

69 3. Using the on-screen keyboard, edit the information on the Patient Info and Comments tabs. 4. Tap Save to save the patient s information and return to the Patients screen. Deleting a Patient From the Database To delete a patient from the database, follow these steps: 1. On the Patients screen, select the check boxes that correspond with the patients whom you want to delete (see the following figure, left). To select all patients, tap in the header. Tap again to deselect all patients. 2. Tap, and then tap OK when the Confirm Delete message appears (see the following figure, right). Figure 48: Selecting patient check boxes on the Patients screen Figure 49: The Confirm Delete message Rapid Programmer System Clinician s Manual 63

70 Combining Patient Data The combining patient data feature allows you to combine information from two patient records into one record. The patient name from only one patient is kept, and only the most recent session of the two patients is retained. In order for the two patient record s to be combined, either must be true: The generator in each record must share the same model number and serial number The generator in one of the patient records must not have a model number and serial number assigned To combine patient data, follow these steps: 1. On the Patients screen, select the check boxes from the list for the two records you want to combine (see the following figure, left). 2. Tap. The Combine Patients screen appears (see the following figure, right). Figure 50: Selecting patient check boxes on the Patients screen Figure 51: The Combine Patients screen 3. Select which patient s record will store the combined information by tapping the button next to that patient s name. NOTE: The patient information from the most recent session will be saved. 4. Tap OK. The records are combined and the unselected patient record is deleted. 64 Rapid Programmer System Clinician s Manual

71 Merging and Copying Patient Database s The merge feature allows you to combine two patient databases from two separate database cards. The copy feature allows you to copy the patient database from one database card to another. To merge or copy data, follow these steps: 1. In the lower left corner of the Patients screen, tap Database, and then tap either Merge or Copy. 2. When the Confirm Merge or Confirm Copy message appears, tap OK, and follow the on-screen instructions. Figure 52: The Database menu on the Patients screen Rapid Programmer System Clinician s Manual 65

72 Exporting Patient Records On the Patients screen, you can export patient records to a database card as a file (PatientExport.txt) that can be opened on a computer using a database card reader. CAUTION: When viewing files on the database card with a database card reader, view only the PatientExport.txt file and do not edit or delete any other files on the card. Otherwise, you may inadvertently delete the database from the card. To export patient records, follow these steps: 1. Ensure that the database card containing the records is inserted in the programmer. 2. From the list on the Patients screen, select the check boxes of the patient records to export. 3. Tap. The Confirm Export message appears (see the following figure, left). 4. Tap OK. 5. When the Export Complete message appears, tap ok (see the following figure, right). Figure 53: The Confirm Export message Figure 54: The Export Complete message 66 Rapid Programmer System Clinician s Manual

73 Restoring a Database The programmer automatically backs up the database before every major database operation. The programmer stores up to seven daily backup files that are captured at the start of the first session of each day, as well as up to three monthly backup files that are captured at the start of the first session of the month. If something unwanted happens to the database, you can try to restore it from one of these backup files. To restore a database, follow these steps: 1. Ensure that the database card containing the patient database is inserted. 2. On the Main Menu screen, tap the Tools menu, and then tap Restore Database. The Restore Database screen appears. Figure 55: The Restore Database screen 3. From the list of available files, tap the date of the file you want to restore. 4. Tap OK. When the Restore Complete message appears, tap ok to return to the Main Menu screen. Rapid Programmer System Clinician s Manual 67

74 Printing You may print programming and database data from the Rapid Programmer system using the St. Jude Medical Bluetooth printer (Model 3823). NOTE: The Rapid Programmer system can print to the Bluetooth printer from a distance up to 10 m (33 ft). NOTE: It may take up to a minute to start printing after you tap Print. Types of Printable Reports The following table lists the types of reports you can print and the locations from which you can print them. To see full examples and to learn more about the information contained on these reports, see Appendix A. Table 6: Types of printable reports Report Type Description Print From... Neurostimulation record Patient list Lead diagnostics report Contains a record of all programs, as well as generator and lead information, for a selected patient Lists patient names from the database and the dates of their last revisions Shows the results of the diagnostic testing performed on a generator and leads for a specific program NOTE: This report is available only for the Eon, Prodigy, Protégé, and MTS systems. The Main Menu screen (prints the record from the last testing session only). The Programs tab on the Testing screen. The Patient Details screen for a selected patient in the database. The Patient History Details screen in the patient records database. The Diagnostic Summary screen after measuring impedance. 68 Rapid Programmer System Clinician s Manual

75 Printing a Neurostimulation Record To print a neurostimulation record, follow these steps: 1. Do one of the following: If printing from the Main Menu screen, tap. If printing from the Testing screen or Patient Details screen, tap. 2. Ensure that the printer is turned on. 3. On the Print Preview screen, tap Print. 4. If a Multiple Printers Found message appears, tap the box in the message to open a list of nearby printers, select a printer from the list, and then tap OK. 5. After you have finished printing, tap Done and turn off the printer. Figure 56: The Print Preview screen for a neurostimulation record Rapid Programmer System Clinician s Manual 69

76 Printing the Patient List To print the patient list, follow these steps: 1. On the Patients screen, tap. 2. Ensure the printer is turned on. 3. On the Print Preview screen, tap Print. 4. If a Multiple Printers Found message appears, tap the box in the message to open a list of nearby printers, select a printer from the list, and then tap OK. 5. After you have finished printing, tap Done and turn off the printer. Figure 57: The Print Preview screen for a patient list 70 Rapid Programmer System Clinician s Manual

77 Printing a Lead Diagnostics Report To print a lead diagnostics report, follow these steps: 1. Ensure the printer is turned on. 2. On the Diagnostic Summary screen, tap Print. 3. If a Multiple Printers Found message appears, tap the box in the message to open a list of nearby printers, select a printer from the list, and then tap OK. 4. When you have finished printing, tap OK and turn off the printer. Figure 58: The Diagnostic Summary screen Rapid Programmer System Clinician s Manual 71

78 Cleaning and Maintaining the Rapid Programmer System This section provides tips and other information to help you clean and maintain the Rapid Programmer system and keep it running its best. Handling the Programmer To properly handle the programmer, follow these tips: Handle the programmer with care. It is a sensitive electronic device that can be damaged by rough handling (e.g., dropping it on the ground). Do not expose the programmer to prolonged direct sunlight. Use the programmer within a safe range of environmental conditions (see Appendix B). Avoid exposing the programmer to sand, dust, and other environmental hazards. Keep the programmer away from food and beverages, and avoid doing things that might get the programmer wet. The programmer is not waterproof. If the programmer does get wet, do not use it. Contact Technical Support for help. Cleaning the Programmer To properly clean programmer, follow these tips: When cleaning or disinfecting the programmer, turn off the programmer and unplug the power adapter. Use a soft, dry cloth to remove dust from the screen. Never use glass cleaners. Clean the programmer by wiping off the outer surface using a damp, lint-free cloth and a small amount of mild soap. Do not submerge the programmer or use a cloth that is soaking wet. Do not use alcohol, cleaning solutions, or solvents to clean the programmer. They may damage the surface finishes of the programmer. 72 Rapid Programmer System Clinician s Manual

79 Storing and Transporting the Programmer To properly store and transport the programmer, follow these tips: If storing the programmer for a month or longer, turn the programmer off, fully charge the programmer battery, and remove and store the programmer battery separately to maximize its life. Store the programmer and the programmer battery in a cool, dry place (see Appendix B). Transport the programmer in a carrying case. If you are carrying the programmer in a briefcase, purse, or any other carrying case, make sure no objects in the case are pressing on the device. Do not put heavy or sharp objects on the programmer. Rapid Programmer System Clinician s Manual 73

80 Troubleshooting This section provides troubleshooting suggestions for issues you might have with the Rapid Programmer system. For additional information, call Technical Support. When you call, be ready to give the representative information about what you were doing when the error occurred and what error messages appeared. Troubleshooting Chart Typically, the Rapid Programmer system displays a message for issues associated with programming patients and managing records. If you are experiencing issues, check the programmer screen for a message and follow any instructions it gives to correct the issue. If you still experience the issue or if you experience an issue without receiving an on-screen message, refer to the following table for possible causes and solutions. NOTE: In the following table, the term programmer refers to the Rapid Programmer system. The term patient programmer refers to the patient programmer for the neurostimulation system. Table 7: Possible causes and solutions for potential issues Problem Possible Cause Possible Solution Programmer has no power or has lost power. Programmer will not charge. Programmer s battery is drained. Programmer s battery is depleted or defective. Programmer is damaged or malfunctioning. Power adapter or car charger is disconnected from the programmer. Correct plug adapter (voltage converter) is not connected to the power adapter s plug. Power adapter or car charger is defective. Programmer s battery is depleted or defective. Programmer is damaged or malfunctioning. Recharge the battery using the power adapter or the car charger. Replace the battery. Replace the programmer. Connect the power adapter or car charger to the programmer. Connect the appropriate plug adapter (voltage converter) to the power adapter s plug. Replace the power adapter or car charger. Replace the battery. Replace the programmer. 74 Rapid Programmer System Clinician s Manual

81 Problem Possible Cause Possible Solution Nothing is displayed on the screen. Programmer will not respond to input. Report will not print from the printer (Model 3823). Programmer is off or has timed out. Programmer s battery is drained. Programmer s battery is depleted or defective. Screen is damaged or malfunctioning. Turn on the programmer. Recharge the battery using the power adapter or the car charger. Replace the battery. If the programmer appears to be powered on but without display, the screen may be defective. Contact Technical Support. Programmer has locked up. Perform a soft reset. Touch-screen interface is damaged Replace the programmer. or malfunctioning. Printer is off. Printer is out of paper. Interference is disrupting Bluetooth communication. Turn on the printer. Add a paper roll to the printer. Turn off or remove the source of the interference. -OR- Printer is damaged or malfunctioning. Move away from the interference. Replace the printer. Rapid Programmer System Clinician s Manual 75

82 Problem Possible Cause Possible Solution Programmer is not communicating with the IPG. Programmer is in demo mode. Patient programmer is off or has timed out and is in standby mode. Batteries in the patient programmer are depleted. Exit the programming session and return to the Main Menu screen. Restart the programming session by tapping the New Session button or the Intra-Op button as desired. Turn on the patient programmer. Ensure that the screen displays COMPUTER COMMUNICATIONS. Replace the batteries in the patient programmer. Programmer battery is drained. Charge the programmer battery. IrDA cable is disconnected. Connect the IrDA cable to the CF card cable and the patient programmer. CF card cable is disconnected or improperly seated in the programmer Connect the CF card cable to the IrDA cable, and properly seat the CF card cable in the programmer. NOTE: When removing the CF card cable, wait about 3 seconds before reinserting it into the programmer. Communication wand is not connected to the patient programmer. Communication wand is not directly over the IPG site. IrDA cable is damaged or malfunctioning. CF card cable is damaged or malfunctioning. Communication wand is damaged or malfunctioning. Patient programmer is damaged or malfunctioning. Programmer is damaged or malfunctioning. Connect the wand to the patient programmer. Center the wand directly over the IPG site. Replace the IrDA cable. Replace the CF card cable. Replace the wand. Replace the patient programmer. Replace the programmer. 76 Rapid Programmer System Clinician s Manual

83 Problem Possible Cause Possible Solution Programmer is not communicating with the MTS system. Programmer is in demo mode. MTS system is off or has timed out and is in standby mode Batteries in the MTS system are depleted. Exit the programming session and return to the Main Menu screen. Restart the programming session by tapping the New Session button or the Intra-Op button as desired. Turn on the MTS system. Ensure that the screen displays COMPUTER COMMUNICATIONS. Replace the batteries in the MTS system. Programmer battery is drained. Charge the programmer battery. MTS communication cable is disconnected. CF card cable is disconnected or improperly seated in the programmer Connect the MTS communication cable to the programmer and the MTS system. Connect the CF card cable to the MTS communication cable, and properly seat the CF card cable in the programmer. NOTE: When removing the CF card cable, wait about 3 seconds before reinserting it into the programmer. MTS communication cable is damaged or malfunctioning. CF card cable is damaged or malfunctioning. MTS system is damaged or malfunctioning. Programmer is damaged or malfunctioning. Replace the MTS communication cable. Replace the CF card cable. Replace the MTS system. Replace the programmer. Rapid Programmer System Clinician s Manual 77

84 Problem Possible Cause Possible Solution Patient is not receiving stimulation. Programmer is in demo mode Stimulation is off. IPG battery is low and stimulation shut off (rechargeable IPGs). Lead is damaged or has become disconnected. Exit the programming session and return to the Main Menu screen. Restart the programming session by tapping the New Session button or the Intra-Op button as desired. Turn on stimulation. Recharge the IPG. Check impedance on the lead using the programmer. If impedance is high, then the lead may be damaged or disconnected. Check the connections or consider replacing the lead. Parameter boxes on the Testing screen turn yellow. IPG battery is depleted (nonrechargeable) or unable to hold a charge (rechargeable). IPG is damaged or malfunctioning. Generator has reached its output limit Lead is damaged or has become disconnected. Refer to Measuring Impedance for more information. Replace the IPG. Contact Technical Support. Replace the IPG. Contact Technical Support. Reduce the amplitude or pulse width. -OR- Set additional polarities (anode or cathode) on the lead. Check impedance on the lead using the programmer. If impedance remains high despite changes to program settings, then the lead may be damaged or disconnected. Check the connections or consider replacing the lead. Refer to Measuring Impedance for more information. 78 Rapid Programmer System Clinician s Manual

85 Problem Possible Cause Possible Solution Patient record will not export to database card. Database is not restored from the database card. Database card is not seated properly in the card slot on the programmer. Remove and reseat the database card to ensure it is inserted properly. Database card is full. Use another database card. Database card is locked from editing. Database card is damaged or corrupt. Database card is not seated properly in the card slot on the programmer. Programmer will not read the data stored on the database card. Exit the patient database and return to the Main Menu screen, remove the database card and slide the lock on the side of the card to a down (unlocked) position, and reinsert the database card. Replace the database card. Remove and reseat the database card to ensure it is inserted properly. Try to view files on the database card using another programmer. Database card is locked from editing. Database card is damaged or corrupt. If the files are viewable, then the programmer may be malfunctioning. Contact Technical Support. Exit the patient database and return to the Main Menu screen, remove the database card and slide the lock on the side of the card to a down (unlocked) position, and reinsert the database card. Replace the database card. (You will not be able to restore your database.) Rapid Programmer System Clinician s Manual 79

86 Performing a Soft Reset If the programmer is locked and will not respond to input, you can use the soft reset feature to restart the system. This is similar to rebooting your computer. When you soft reset the system, stored patient records and configured settings are unaffected. Note that even if the programmer is locked, you can still turn off stimulation to the patient using the power key on the patient programmer or MTS system. CAUTION: When performing a soft reset, you will lose any unsaved data. If the Device Is Locked Using the stylus, press the small recessed button located on the right side of the programmer. The system will reset and return to the Main Menu screen. Figure 59: Using the stylus to perform a soft reset If the System Responds to Input 1. On the Main Menu screen, tap the Tools menu, and then tap Reset PDA. The Confirm Reset message appears. 2. Tap OK. The programmer resets. 80 Rapid Programmer System Clinician s Manual

87 Reinstalling the Software If you are having problems operating your system after performing a soft reset, you may try reinstalling the software to reinitialize the system. When you reinstall the software, stored patient records and configured settings except system volume are unaffected. To reinstall the software, follow these steps: 1. On the Main Menu screen, tap Tools, then tap Reinstall Software. The Confirm Reinstall message appears. Figure 60: The Confirm Reinstall message 2. Tap OK. The Installing Rapid Programmer 3.7 screen appears and the PDA reinstalls the programmer software. 3. When the Installation Complete screen appears, tap Finish. The programmer restarts. Copying Log Files If an error occurs and you are unable to operate the programmer, you can copy the log files to a database card and then send the card to St. Jude Medical for inspection or call Technical Support for further instructions. To copy log files to a database card, follow these steps: 1. Insert a database card in the card slot on top of the programmer. Rapid Programmer System Clinician s Manual 81

88 2. On the Main Menu screen, tap the Tools menu, and then tap Copy Log Files. 3. When the Copy Complete message appears, tap OK. Returning the Rapid Programmer System for Service If you must return the Rapid Programmer system for service, keep your database card and erase the database from the programmer before you return it. To do this, follow these steps: 1. Remove the database card containing the patient data, and store the database card in a safe place to maintain data integrity (see Appendix B for storage conditions). 2. From the Main Menu screen, tap Settings, then Brightness. The Brightness Level screen appears. 3. If the on-screen keyboard is not visible, tap to open it. 4. Type clear and then tap the ENTER key ( ). 5. In the Clear All Patient Data message that appears, tap OK. All backup databases are deleted from the Rapid Programmer system. Figure 61: The Clear All Patient Data message 6. When the message appears confirming that the patient data has been deleted, tap OK. 7. Return the programmer to St. Jude Medical (see Technical Support ). 82 Rapid Programmer System Clinician s Manual

89 Service and Ordering Information This section provides information for contacting Technical Support and for ordering parts and accessories. Technical Support For technical questions and support for you St. Jude Medical neuromodulation product, use the following information: (toll-free within North America) For additional assistance, call your local St. Jude Medical representative. Rapid Programmer System Clinician s Manual 83

90 Ordering Information The following table lists model numbers for ordering the kit, kit components, and accessories for the Rapid Programmer system. Table 8: Accessories and kit components for the Rapid Programmer system Model Number Description 1273 MTS communication cable 1280 IrDA communication cable 1291 Compact flash to DB9 cable 1300 Printer paper 1303 Battery for Bluetooth printer 1304 Car charger, RP Model Power adapter for Bluetooth printer 1601 Rapid Programmer case 1622 Power adapter for RP Model Stylus for RP Model MTS joining sleeve for RP Model Extended battery for RP Model Rapid Programmer database card 3823 Bluetooth printer 3834 Rapid Programmer 84 Rapid Programmer System Clinician s Manual

91 Appendix A: Printable Reports of the Rapid Programmer System This section provides examples of the types of reports that you can print from the Rapid Programmer system and provides information about what information is available on each report. For more information on printing reports, see the Printing section. The Rapid Programmer system can print the following types of reports : Neurostimulation record Patient list Lead diagnostics report Neurostimulation Record A neurostimulation record contains a record of all programs, as well as lead and generator information, for a selected patient. The following figure shows the location of information on the report Legend: 1. Patient information. 2. Generator and lead information, including the initial session date and the serial number of the generator. 3. Information about the device the patient uses to control stimulation, including the serial number of the device and the number of hours that stimulation has been on. 4. Date of the programming session. 5. Program number for the stim set settings that follow. 6. Stimulation map of the associated program. 7. Stim set settings of the associated program. Stim set are listed in ascending order (1, 2, 3, etc.). Figure 62: Parts of a neurostimulation record Rapid Programmer System Clinician s Manual 85

92 Patient List The patient list shows patient names from the database and provides the dates of their last revisions. The following figure shows the location of information on the report. 1 2 Legend: 1. Patient name. 2. Date of the patient s last programming session. Figure 63: Parts of a patient list Lead Diagnostics Report A lead diagnostics report shows the results of the diagnostic testing (impedance testing) performed on a generator and leads for a program on an Eon, Prodigy, Protégé, or MTS system. The following figure shows the location of information on the report Legend: 1. Patient name and information about the system being calibrated, including stimulator and lead information. 2. Session date of the diagnostic test. 3. Number of the electrode that was tested. 4. Impedance reading of the associated electrode. Figure 64: Parts of a lead diagnostics report 86 Rapid Programmer System Clinician s Manual

93 Appendix B: Specifications The following tables show hardware specifications for the Rapid Programmer system (Model 3834). Table 9: Rapid Programmer system specifications System Specifications OEM Model Memory Display Communications Indicator Lights Battery HP ipaq 200 series 128 MB SDRAM 256 MB flash ROM 4.0-in. VGA TFT, resolution px Bluetooth wireless technology 2.0, 10 meter range (approximately 33 feet), high-speed, low-power, short-range wireless communication with other Bluetooth devices, support collaborative coexistence with IEEE b/g Solid amber: battery charging Solid green: battery charge complete Solid blue: Bluetooth wireless technology is on 3800 mah, lithium ion, removable, rechargeable battery Table 10: Rapid Programmer system physical specifications Physical Specifications Metric U.S. Height cm 5.27 in Width 7.54 cm 2.97 in Depth 2.41 cm 0.95 in Weight g 8.40 oz Table 11: Rapid Programmer system storage and operating conditions Storage and Operating Conditions Metric U.S. Temperature Range Operating 10 C 40 C 50 F 104 F Storage -10 C 55 C 14 F 131 F Humidity Range (Noncondensing) Operating 30% 75% 30% 75% Storage 30% 90% 30% 90% Pressure Range Operating kpa psi Storage kpa psi Rapid Programmer System Clinician s Manual 87

94 Appendix C: Regulatory Statements This section contains regulatory statements about the system or its accessories. Statement of FCC Compliance This equipment has been tested and found to comply with the limits for a Class B digital 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 radiate radiofrequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to 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. Consult the dealer or an experienced radio/tv technician for help. Operation is subject to the following two conditions: This device may not cause harmful interference. This 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 operate the equipment under FCC rules. 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. 88 Rapid Programmer System Clinician s Manual

95 Disposal Guidelines for Battery-Powered Devices This device contains a battery and the label is affixed to this device in accordance with European Council directives 2002/96/EC and 2006/66/ EC. These directives call for separate collection and disposal of electrical and electronic equipment and batteries. 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. Rapid Programmer System Clinician s Manual 89

96 Appendix D: Symbols and Definitions The following symbols may be used in this document and on some of the products and packaging. Table 12: Symbols and definitions Symbol Description Caution, consult accompanying documents Consult instructions for use Follow instructions for use on this website Magnetic Resonance (MR) Unsafe, an item poses unacceptable risks to the patient, medical staff, or other persons within an MR environment Expiration date Date of manufacture Manufacuring facility Temperature limits for storage conditions Humidity limits Pressure limits Catalog number Manufacturer Contents quantity Programmer Accessories SN Serial number 90 Rapid Programmer System Clinician s Manual

97 Symbol Description Batch code Prescription use only 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 consequences for the environment 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 product for recycling, please contact St. Jude Medical. Complies with AS/NZS standards: AS/NZS 4268:2003 This device is listed by Underwriters Laboratories (UL) Inc. as certified This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. Rapid Programmer System Clinician s Manual 91