PROGRAMMER MANUAL Programmer Model 2740 ONLY
The following is a trademark of Inspire Medical Systems, Inc.: Inspire® This product and/or the use of this product in a method may be covered by one or more patents or patent applications, available at www.inspiresleep.com/patents.
TABLE OF CONTENTS Explanation of Symbols iii Explanation of Symbols on Package Labeling and Device iii How to Use this Guide ix Chapter 1: Therapy Overview 1 Introduction 1 Terminology 2 Therapy Icons 7 Chapter 2: Programmer Components 9 Package Contents 9 Chapter 3: Getting Started 17 Turning On the Programmer 17 Starting a Session 20 Exiting a Session and Turning Off the Programmer 29 Chapter 4: Screen Descriptions 31 Common Screen Elements 31 Start Screen 34 Programmer Settings Screen 35 Home Screen
Programmer Cable - Error Mode 85 Settings 85 Therapy 86 Waveforms 88 Reports 88 Abnormal Impedances 88 Generator Reset 89 Exporting 89 Chapter 7: Warnings and Precautions 91 Warnings 91 Precautions 91 Chapter 8: Supplemental Information 95 Programmer Maintenance 95 Default Settings 96 Device Specifications 97 Protected Health Information 99 Introduction 99 Essential Performance 99 FCC Notice (USA) 99 Electromagnetic Compatibility Declarations 101 Unused Tablet Features 107 Disposing of Programmer 110 Cha
Explanation of Symbols Explanation of Symbols on Package Labeling and Device Refer to the package label and device labels to see which symbols apply.
Symbol Description Temperature limitation Atmospheric pressure limitation Relative humidity limitation Federal Communications Commission notice (USA) For US audiences only Manufacturer Product complies with 2002/96/EC Non-ionizing electromagnetic radiation iv English Programmer Model 2740
Symbol Description 2797 Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive 90/385/EEC. Conformité Européenne; compliance to EMC Directive and Low Voltage Directive of the European Union. European authorized representative Compliance with Underwriters Laboratories for general product safety in accordance with UL 60950-1 (ITE) and CAN/CSA C22.2 No.
Symbol Description CEC Level V compliant UL recognized component mark IECEE CB compliant Indoor use only TUV/T-Mark for IEC/EN 60601-1 Compliance Degree of ingress protection per EN60529 Degree of ingress protection per EN60529 The Inspire Programmer is MR unsafe vi English Programmer Model 2740
Symbol Description The Technical Conformity mark signifies that this device complies with Japan Radio Law The Regulatory Compliance Mark (RCM) signifies that this device complies with Australian Communications and Media Authority requirements Programmer Model 2740 English vii
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How to Use this Guide This guide presents information for users of the Inspire Programmer (Model 2740) for programming an Inspire Generator. The chapters are organized as follows: • Therapy Overview This chapter is a brief overview of Inspire therapy and its indications along with programmer terminology and icons. • Programmer Components This chapter describes the programmer tablet, programmer cable, and accessories.
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Chapter 1: Therapy Overview This chapter is a brief overview of the Inspire system technology and icons. Introduction The Inspire® Upper Airway Stimulation (UAS) system (Figure 1-1) stimulates the hypoglossal nerve, synchronous with respiration, to elicit a neuromuscular response at the base of the tongue and to maintain airway patency in patients with moderate to severe obstructive sleep apnea (OSA).
Intended Use Inspire Upper Airway Stimulation therapy is intended to treat OSA patients meeting specific criteria. Please refer to the Inspire System Implant Manual for a detailed list of the indications for use and contraindications, clinical warnings/precautions, and clinical summary. Therapy Phases The Inspire therapy takes place in four phases: (1) implant procedure, (2) therapy acclimation, (3) titration, and (4) therapy maintenance.
General Therapy Terms Table 1-1 defines general therapy terms related to Inspire therapy. Table 1-1. General Therapy Terms Term Definition Current generator settings The stimulation and sensing settings currently used by the generator. The combined stimulation and sensing settings are also known as the therapy settings. Default settings Default therapy settings determined by the generator manufacturer.
Stimulation Setting Terms Table 1-2 defines terms related to stimulation settings. Table 1-2. Stimulation Setting Terms Term Definition Amplitude The stimulation level measured in volts. Increasing amplitude will increase stimulation strength; decreasing amplitude will decrease stimulation strength. Electrode configuration The electrodes and polarities used to deliver the stimulation.
Sensing Setting Terms Table 1-3 defines terms related to sensing settings. Table 1-3. Sensing Setting Terms Term Definition Exhalation The end of inhalation as determined by the generator. The generator detects that exhalation has occurred when a decrease in the sensor signal meets the exhalation sensitivity and threshold criteria.
Table 1-3. Sensing Setting Terms Term Maximum stimulation time Definition The maximum time that stimulation is delivered during one respiratory cycle. This setting also controls the length of the stimulation burst used for test stimulation. Note: This is an advanced setting. Off period (Hard) A percentage of the respiratory period during which stimulation will not be delivered. The hard off period follows immediately after the generator detects an exhalation.
Therapy Icons Electrodes Electrodes are used to deliver stimulation to the patient. There are three electrodes in the Inspire system, two on the lead and one that is integrated into the generator case. The two lead electrodes are designed so that one center electrode is placed between the outer electrode. Table 1-4 describes the icons used to represent electrodes on the programming screens. See “Electrode” on page 47 for more information. Table 1-4.
Generator Communication A communication icon (Figure 1-3) is used on certain programming buttons to indicate when communication with the generator is required to execute an action, such as: • • • • • • Connect to generator Configure generator Test Connection Turn On/Off Therapy Test Stimulation Start Waveform Figure 1-3. Communication Icon When the programmer communicates with the generator, a large communication icon displays (Figure 1-4).
Chapter 2: Programmer Components This chapter describes the programmer components and accessories. Package Contents The programmer comes packaged with all components needed to work with an Inspire generator.
LCD screen Status lights Figure 2-1. Tablet Front Table 2-1.
Table 2-2.
Tablet Right Side The right side of the tablet (Figure 2-2) contains the USB port. Unused controls are listed in Chapter 8. USB port Figure 2-2. Tablet Right Side Tablet Left Side The left side of the tablet (Figure 2-3) contains the power adapter port. Unused controls are listed in Chapter 8. Figure 2-3.
Tablet Back The back of the tablet (Figure 2-4) has a hand strap to assist in holding the tablet. Hand Strap Figure 2-4. Tablet Back Tablet Battery The tablet has a high-capacity lithium-ion battery. When fully charged, the tablet can run on battery power for more than three hours. For information about battery status indicators and charging the battery, see “Charging Status” and “Charging Battery” on page 17. Warning: To avoid personal injury, handle the battery with care.
Programmer Cable The programmer cable is the communications interface between the generator and the tablet. The programmer cable includes the programmer head, the controller, and a medical-grade power supply with power cord (Figure 25). The programmer cable has two operating ranges, one for very short range communications with the generator (up to 5 cm or 2 in) and another for short range communication with the tablet (approximately 5 to 10 m or 16 to 33 ft). Controller Programmer Head Figure 2-5.
Portability Kit The portability kit provides a convenient way to safely transport the programmer. The portability kit consists of a computer bag and a luggage tag for your contact information (Figure 2-7). Figure 2-7.
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Chapter 3: Getting Started This chapter describes how to start and end a programming session. Turning On the Programmer This section describes how to turn on the programmer. The tablet can be operated either on battery power or plugged into an electrical outlet. The battery should be fully charged prior to operating the programmer on battery power.
1 2 3 Figure 3-1. Tablet Power Supply Connections Powering On Tablet Press and hold the power button on the top of the tablet (Figure 3-2) until the power light is illuminated. Once the tablet powers on and the software loads, the Start screen displays. . Power Button Figure 3-2.
Connecting Programmer Cable to Power The programmer cable must be plugged into an electrical outlet to operate. Complete the following instructions to connect the programmer cable to power (Figure 3-3). 1. Connect the programmer cable power supply to the programmer cable. 2. Connect the power cord to the programmer cable power supply. 3. Connect the power cord to an electrical outlet (100–240 VAC). . 2 1 Figure 3-3.
Starting a Session Navigating the Start Screen Once the programmer is powered on, the Start screen displays (Figure 3-4). Figure 3-4.
The buttons on the Start screen are described in Table 3-1. Table 3-1. Start Screen Button Descriptions Button Connect to Generator Description • Starts a programming session with a generator. • Accesses the Home screen and all session activities. Note: Button is disabled until the tablet has established a connection to the programmer cable. Test Connection • Evaluates communication strength before connecting to the generator and is used to determine best position for programmer cable and head.
Programmer Cable Status The programmer cable connection status displays one of the following messages in the lower-left corner of all programming screens. • Programmer Cable Connected — Wireless link between tablet and programmer cable is established. Status background color is blue. Programmer cable controller status light is fully lit (see Figure 3-5). Connection buttons are enabled. • Searching for Programmer Cable — Wireless link between tablet and programmer cable is not established.
Using the Touchscreen To select a programming button, gently touch the displayed button on the tablet screen (Figure 3-6). Figure 3-6. Select Programming Buttons on Touchscreen Adjusting Programmer Settings Before starting a session, it is important to adjust the programmer settings to ensure the accuracy of the data collected. Note: Settings adjustments can be made without a generator present. To adjust the programmer settings: 1. 2. 3. 4. 5. 6. Select the Settings button from the Start screen.
Setting Data Controls Select the Settings button from the Start screen to adjust the following: • USB Export — Select this check box to enable or disable the option to transfer session reports to the Inspire USB flash drive. • Patient Information Storage — Select this check box to enable or disable the storage/editing of patient name and ID. • Patient Information Export — Select this check box to enable or disable the exporting of patient details.
Testing Connection Strength Complete the following steps to evaluate programmer head positioning before connecting to the generator. Start the process from either the programmer cable or tablet. Starting the process from the programmer cable: 1. 2. 3. 4. 5. Ensure the programmer cable is connected to power. Position the programmer head directly over the generator (Figure 3-7). Press the Test Connection button on the controller. The strength gauge will display one of the following ratings in Table 3-2.
Table 3-2. Communication Strength Ratings Generator not found Electrical Interference Figure 3-7. Correct Positioning of Programmer Head over Generator Programmer Head Strength Gauge A strength gauge is located on the top of the programmer head (Figure 3-7) so that it can be observed when the programmer head is positioned over the generator. The strength ratings are described in Table 3-2.
Table 3-3. Communication Screens Message Connecting to generator Event Displays when the Connect to Generator button has been selected. Action Wait for connection to be established. Configuring generator Displays when the Wait for connection to be established. generator is being updated for the start of a session. Generator Not Found or Electrical Interference Displays when the programmer head is not correctly positioned over the generator.
Table 3-4. Communications Troubleshooting Problem Action No Connection Between Tablet Ensure that the tablet is within wireless range. Move tablet closer and Programmer Cable to programmer cable if necessary. Ensure programmer cable is powered on. Check for loose cord connections and restore power to the programmer cable. Communication Buttons Disabled Connect programmer cable to power. Generator Not Found Reposition programmer head directly over generator.
Exiting a Session and Turning Off the Programmer Allow all communications to complete before a patient leaves. If a patient is allowed to leave during a test or impedance measurement, the generator may not be restored to therapy settings. Verify that all setting changes have been made on the Home screen before exiting a session. Always end sessions properly, according to the following instructions: 1. From any screen, select the Home button to access the Home screen. 2.
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Chapter 4: Screen Descriptions This chapter provides descriptions of the programmer screens. Common Screen Elements All programmer screens, with the exception of the Start screen, Programmer Settings screen and Select a Patient screen, display common information in the screen header (Figure 4-1). Screen Header Information Figure 4-1. Common Information Screen Header • Therapy Status — When the therapy is on, the therapy status displays Therapy is On.
Figure 4-2. Start Therapy Screen Screen Footer Information All programmer screens also display common information in the screen footer. (Figure 4-3): Programmer cable status Programmer battery status appears here if capacity is low Figure 4-3.
Programmer Cable Status The programmer cable connection status displays one of the following messages in the lower-left corner of all programming screens. • Programmer Cable Connected — Wireless link between tablet and programmer cable is established. Status background color is blue. Programmer cable controller status light is fully lit (see Figure 3-5). Connection buttons are enabled. • Searching for Programmer Cable — Wireless link between tablet and programmer cable is not established.
Start Screen Figure 4-4. Start Screen The buttons on the Start screen (Figure 4-4) are described in Table 4-1. Table 4-1. Start Screen Button Descriptions Button 34 English Description Connect to Generator • Starts a programming session with a generator. • Accesses the Home screen and all session activities. Note: Button is disabled until the tablet has established a connection to the programmer cable.
Table 4-1. Start Screen Button Descriptions Shut Down • Powers off the tablet. Day Mode • Sets the programmer cable to Day Mode. Night Mode • Sets the programmer cable to Night Mode. Programmer Settings Screen Figure 4-5. Programmer Settings Screen The Programmer Settings screen (Figure 4-5) allows the modification of general programmer settings, including: • • • • Patient data management Date and time Language Number format See “Adjusting Programmer Settings” on page 23 for more information.
Home Screen Figure 4-6.
Therapy Status It is important to review this information at the start of each session. • Amplitude Change — Displays No Patient Change when the patient has not changed the therapy amplitude set during the last session. If the patient has changed the therapy amplitude since the last session, both the last session value and the new patient-selected value display along with a gold change flag as shown in Figure 4-7.
Sleep Study • Button accesses the Sleep Study workflow which guides the user through relevant activities and records any setting changes made. See“Sleep Study” on page 76 for more information. • Status Indicators: – Not Performed indicates activity has not been started. – Started indicates the Sleep Study workflow has been started but not fully completed (Figure 4-8). – Done with a check mark indicates activity has been completed.
Settings Summary A summary of the settings, that are configured to the generator, display in this section of the Home screen. The following items are displayed here. • • • • Amplitude Patient Control Timing — The number of timing settings that have been changed during the session Advanced Stimulation — The number of advanced stimulation settings that have been changed during the session. • Sensing — The number of sensing settings that have been changed during the session.
System Check • Button accesses the System Check workflow which guides the user through troubleshooting activities. See “Start System Check Workflow” on page 63 for more information. • Status Indicators: – Not Performed indicates activity has not been started. – Started indicates the System Check workflow has been started but not fully completed. – Done with a check mark indicates activity has been completed.
Patient Details Screen Figure 4-10. Patient Details Screen Access the Patient Details screen (Figure 4-10) from the Home screen. • • • • Select any field to enable the on-screen keyboard. Use the on-screen keyboard to enter or edit patient information. Select the Save button to save updated patient information and return to the Home screen. Select the Cancel button to reject changes made to patient information and return to the Home screen without saving.
On-Screen Keyboard The keyboard is only enabled when an editable field has been selected. Capital letters display by default on the keyboard. Table 4-2 describes the keyboard buttons and their functions. Table 4-2. On-Screen Keyboard Buttons Button Description Change letter case Backspace Access special characters Move cursor within a field Patient Details Information Fields • Patient Name — Enter the patient’s name. • Patient ID — Enter a patient identifier, such as a medical record number.
Adjust Stimulation Screen The Adjust Stimulation screen is used to modify and test stimulation settings (Figure 4-11). The setting values initially displayed on the screen are the values currently in use by the generator. When setting values are changed and differ from the current generator settings, the fields are highlighted in blue (Figure 4-12). Selecting the Configure button will configure the generator with the highlighted values and clear the highlighting. Figure 4-11.
Timing Use the arrow buttons to increase or decrease the following timing settings. • Start Delay • Therapy Duration • Pause Time See Table 1-2 for definitions of these terms. Figure 4-12. Changed Settings on Adjust Stimulation Screen Programming Buttons The programming buttons on the Adjust Stimulation screen are disabled until a connection to the programmer cable is established. Test Stimulation • The Test Stimulation button requires that the programmer cable is connected.
Configure Select the Configure button to configure the generator with all displayed settings that differ from the current generator settings. It is important to note that if the Configure button is not pressed before leaving this screen, the setting changes will not be saved to the generator. Notes: • The Configure button requires that the programmer cable is connected.
Advanced Screen View Figure 4-13. Adjust Stimulation Screen, Advanced View To modify advanced stimulation settings, select the Advanced tab at the bottom of the screen. • Use the arrow buttons to increase or decrease the following settings. – Rate – Pulse Width – Electrode See Table 1-2 on page 4 for definitions of these terms. • Select the Test Stimulation button to test the settings displayed on the screen.
Electrode Select the Electrode button to change the location at which stimulation is delivered. Electrodes are used to deliver stimulation to the patient. There are three electrodes in the Inspire system, two on the lead and one that is integrated into the generator case. The two lead electrodes are designed so that one center electrode is placed between the outer electrode (Figure 4-14). Generator Case Center Outer Figure 4-14.
Table 4-3.
Adjust Sensing Screen The Adjust Sensing screen (Figure 4-16) allows for real-time evaluation of the respiratory sensor waveform and adjustment of sensing settings. Adjustments to sensing settings can modify when stimulation is delivered during the respiratory cycle. The setting values initially displayed on the screen are the values currently in use by the generator. When setting values are changed and differ from the current generator settings, the fields are highlighted in blue.
Programming Buttons The programming buttons on the Adjust Sensing screen are disabled until a connection to the programmer cable is established. Start Waveform • Select this button to start the generator waveform mode, during which the generator sends real-time data that is graphed on the programmer. Notes: – Starting the waveform will turn therapy on at the current generator settings. If the generator amplitude is 0V, the programmer will automatically change the amplitude to 0.1V.
Figure 4-17. Screenshot Screen Configure Select the Configure button to configure the generator with all displayed settings that differ from the current generator settings. It is important to note that if the Configure button is not pressed before leaving this screen, the setting changes will not be saved to the generator. Notes: • The Configure button requires that the programmer cable is connected. Confirm connection by checking the programmer cable status in the screen footer (Figure 4-3).
Select a Preset Use the Select a Preset button to change sensing settings to one of the following: • Initial Session Settings — Selects the generator sensing settings from the start of the current programming session. • Current Generator Settings — Selects the sensing settings currently in use by the generator. Note: Selecting the Current Generator Settings preset clears all highlighting. • Default Settings — Selects the default sensing settings (see “Default Settings” on page 96 for more information).
Select a Patient Screen The Reports button on the Start screen accesses the Select a Patient screen (Figure 4-19). All patients with whom the programmer has communicated are listed here. Figure 4-19. Select a Patient Screen Patient name, ID, deidentified-ID, date of last session, and generator serial number display for each patient. By default, patients are organized by last session date with the most recent session appearing at the top.
Table 4-4. Select a Patient Screen Buttons To: View patient Do This: Highlight patient name and select View Patient button to access Reports screen. Note: View Patient Button is disabled unless a patient name is highlighted. View next or previous group of patients Select the up or down arrow buttons at the bottom of the screen. Note: If arrow buttons are disabled, there are no additional patients to view.
Figure 4-20. Delete Report Screen Reports Screen Figure 4-21.
The Current Report button on the Home screen accesses the Reports screen (Figure 4-21), where all session reports for the current generator are organized by date and time. The Reports screen can also be accessed by selecting the View Patient button on the Select a Patient screen. Each report summarizes the patient therapy status, recorded levels, and stimulation and sensing settings for a given session. Blue highlighted information with a check mark indicates changes made during the session.
Table 4-5. Reports Screen Buttons Delete a session report Highlight report and select the Delete button to display the Delete Report screen (Figure 4-20). • Select the Delete Selected Report option to remove current report, or • Select the Delete All Reports Before option and specify the date using the arrow buttons to remove multiple reports for the current patient. • Select Cancel button to return to Reports screen.
Figure 4-22.
Stimulation History Screen Figure 4-23. Stimulation History Screen The Stim History button, located in various workflows on the Adjust Stimulation screen and on the Stim History tab of the Reports screen, accesses the Stimulation History screen (Figure 4-23). This screen displays a summary of usage, stimulation levels, and final stimulation settings for a particular date. Refer to Table 4-6 for information about the functions of the buttons on the Stimulation History screen. Table 4-6.
Sensing History Screen Figure 4-24. Sensing History Screen The Sense History button on the Adjust Sensing screen and the Sense History tab on the Reports screen access the Sensing History screen (Figure 4-24). This screen displays a summary of the final sensing settings for a particular date. Refer to Table 4-7 for information about the functions of the buttons on the Sensing History screen. Table 4-7.
Chapter 5: Clinical Programming Sessions This chapter describes implant, device check, and sleep study sessions. Introduction The programmer is used during implant, device checks, and sleep studies to select stimulation and sensing settings that maintain airway patency. When To Use Workflows The tablet software includes workflows intended to guide the user through common clinical scenarios.
Enter Patient Details The first time you connect to a generator, the programmer displays the Patient Details screen before the Home screen. • • • • Select any field to enable the on-screen keyboard. Use the on-screen keyboard to enter or edit patient information. Select the Save button to save updated patient information and return to the Home screen. Select the Cancel button to reject changes made to patient information and return to the Home screen without saving.
Start System Check Workflow 1. Select the drop down arrow next to Advanced Tools on the Session Home Screen. 2. Select the Start button, next to System Check, to start the System Check Workflow. Figure 5-1. Session Home Screen 3. Ensure Stimulation Levels and Waveform are selected, then select the Next Step button from the System Check Workflow Screen. Note: The Electrode Impedances option can be selected if desired. Figure 5-2.
Save Functional Level After the stimulation lead is connected to the generator, complete the following steps to confirm correct electrode placement and correct lead-generator connection: 1. Use the arrow buttons to select the test stimulation amplitude value. 2. Select the Test Stimulation button to deliver one burst of stimulation at the selected amplitude; observe the patient's tongue response. 3. Repeat Steps 1 and 2 until the functional level is reached.
Note: The amplitude will automatically return to its initial value when the workflow was started (for Implant, this should be 0 V). Note: During surgery, the patient’s respiratory rate is controlled by the ventilator. Sensor signal quality typically improves after surgical wounds heal. Figure 5-4. System Check - Waveforms Screen Review Data The Summary screen will allow for the review of data that was collected during the workflow. 1. Review Stimulation Levels data. 2. Review Waveform data. 3.
End Session Before ending the implant session: 1. 2. 3. 4. Confirm that therapy is turned off. Confirm that the amplitude is programmed to 0 V. Confirm that the System Check Workflow has been completed. Select the Exit button on the Home screen. Figure 5-6.
Retain Records Export a session report if desired. Initial Activation The goal during Initial Activation is to program the patient with stimulation and timing settings that will promote effective and comfortable use of Inspire therapy. Initial Activation Overview • • • • Start Session Start Initial Activation Workflow End Session Retain Records Start Session Turn on the programmer and start a programming session by connecting to the generator.
Figure 5-7. Initial Activation - Determine Stimulation Levels Screen Observe Waveform 1. It is recommended to start with the functional level. Select the Set Amplitude button. 2. Select the Start Waveform button and observe the waveform for 3 minutes. Note: This will turn on therapy and deliver stimulation based on the current generator settings. 3. If stimulation is uncomfortable for the patient, decrease the amplitude and select the Set Amplitude button. 4.
Figure 5-8. Initial Activation - Observe Waveform Screen Stimulation Summary 1. Review the Stimulation and Timing settings. 2. If desired, make any final changes. 3. Select the Configure button. 4. Select the Done button. Figure 5-9.
End Session Before ending the Initial Activation session: 1. 2. 3. 4. Confirm that therapy is turned off. Confirm the patient has the desired amplitude and control range. Confirm that the Initial Activation Workflow has been completed. Select the Exit button on the Home screen. Figure 5-10. End Initial Activation - Home Screen Retain Records Export a session report if desired. See “Exporting a Report” on page 81 for instructions.
Start Follow Up Workflow From the Home screen select Start for the Follow Up workflow. If minor amplitude and timing adjustments are desired, select the following Workflow option: 1. Select the Basic option. 2. Select the Next Step button. If advanced programming and improvements in therapy effectiveness are desired, select the following Workflow option: 1. Select the Advanced option. 2. Select the stimulation settings to be evaluated. One or both options can be chosen. 3. Select the Next Step button.
Figure 5-12. Basic Follow-up Screen Advanced Follow Up The following steps apply only to the Advanced Follow Up. Electrodes Complete these steps if the Electrodes option was selected. Evaluate Electrodes 1. Select an electrode option for evaluation. 2. Use the arrow buttons to select the test stimulation amplitude value. 3. Select the Test Stimulation button to deliver one burst of stimulation at the selected electrode and amplitude; observe the patient’s tongue response. 4.
Figure 5-13. Advanced Follow Up - Evaluate Electrodes Screen Select Electrode Amplitude 1. Review the level and tongue motion data that was saved on the previous screen. 2. Select the desired electrode. 3. Select the desired stimulation level if two levels are available. Note: Therapy Amplitude is equivalent to the “Similar to Current Therapy” level. 4. Select Configure to program the new electrode and amplitude. 5. Select the Next Step button. Figure 5-14.
Pulse Width and Rate Complete these steps if the Pulse Width and Rate option was selected. Evaluate Pulse Width and Rate 1. Select a pulse width/rate option for evaluation. 2. Use the arrow buttons to select the test stimulation amplitude value. 3. Select the Test Stimulation button to deliver one burst of stimulation at the selected amplitude and pulse width / rate combination; observe the patient’s tongue response. 4.
4. Select Configure to program the new pulse width / rate and amplitude if the desired settings are new. 5. Select the Next Step button. Figure 5-16. Advanced Follow Up - Select Pulse Width and Rate Screen Settings Summary 1. 2. 3. 4. Review the recommended settings. If desired, make additional changes using the arrows and select the Test Stimulation button to evaluate. If there are new settings to program in the generator, select the Configure button. Select the Done button.
Figure 5-17. End Follow-Up - Home Screen Retain Records Export a session report if desired. See “Exporting a Report” on page 81 for instructions. Sleep Study The goal of a Sleep Study is to evaluate the patient’s response to therapy. A polysomnogram (PSG) is used to evaluate sleep quality.
Table 1: Signal Strength Indicators Good Moderate Low Generator Not Found Electrical Interference 4. Affix programmer head in optimal (good) position. 5. Confirm communications signal strength in all sleep positions. Place Programmer Cable in Night Mode (Optional) Full programmer cable lighting may disrupt a patient’s sleep. To disable and dim programmer cable lighting: 1. Turn on the programmer. 2. Select Night Mode from the Start screen.
Figure 5-18. Sleep Study - Setup Screen Adjust Stimulation 1. After the patient has fallen asleep, select the Turn On therapy button and then select the Now or Delay button from the Start Therapy screen. Note: While waiting for the patient to fall asleep, review the patient’s sleep history to determine which sleep positions and stages contribute most to overall AHI. Target these sleep positions and stages to provide the maximum therapeutic benefit to the patient. 2.
Figure 5-19. Sleep Study - Adjust Stimulation Screen Stimulation Settings Summary 1. Review the final sleep study amplitude and current settings. 2. New control limits may be recommended. Select Configure to program any changes. Note: Consult the managing physician if a change to the amplitude is desired. 3. Select the Done button. Figure 5-20.
End Session Before ending the Sleep Study Session: 1. Confirm that the Sleep Study workflow has been completed. 2. Select the Exit button on the Home screen. Figure 5-21. Ending the Sleep Study Session - Home Screen Retain Records Export a session report if desired. See “Exporting a Report” on page 81 for instructions.
Exporting a Report 1. Attach the Inspire USB flash drive to the tablet. 2. Select the Reports button on the Start screen. 3. Highlight the patient’s name and select the View Patient button. 4. Confirm that the correct session report is displayed and select the Export button. Note: If Export button is disabled, go to Programmer Settings screen to enable USB export. Select Export Selected Report button to export the current report only. 5.
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Chapter 6: Troubleshooting This chapter contains solutions to problems that may be encountered during programmer use. Communications For problems commonly associated with communications, see "Testing Connection Strength" on page 25. If those steps do not resolve the problem, review the following solutions. Electrical Interference The presence of electrical equipment near the programmer cable or generator may interfere with communications.
Cannot Establish Connection to Programmer Cable If the programmer cable status line in the screen footer always displays “searching for programmer cable”: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Navigate to the Start screen. Ensure that the programmer cable is powered on. Move tablet to within 1 m (3 ft) of the programmer cable. If this does not resolve the problem, navigate to the Home screen and select the Exit button to end the session and display the Start screen.
Abnormal Charging Condition A blinking power status light indicates an abnormal charging condition. Check that the tablet power cord is properly inserted into the tablet and that the device is not charging in high temperature conditions. Programmer Cable - Error Mode If the programmer cable detects an error, it will enter a error mode and will display orange lights as shown below (Figure 6-2).
Programmer Settings Screen Start Screen Settings button Language menu Save button Figure 6-3. Change Language Buttons If programmer screens do not display the correct number format, use the Programmer Settings screen to change the number format. Therapy Setting Changes Not in Generator If setting changes made during a session do not appear on the Home screen, in a session report, or in the generator: 1. Return to the appropriate programming screen and repeat the desired setting changes. 2.
Jerky or Halting Stimulation Jerky or halting stimulation can occur as a result of connection interrupting stimulation. To reduce the likelihood of halting stimulation: 1. Turn off therapy before testing stimulation or changing generator settings. 2. Reposition programming head to achieve stronger signal strength. Measure Impedances The Measure Impedances screen (Figure 6-4) can be accessed from the System Check workflow.
Waveforms Waveform Is Not Moving First, confirm that waveform mode is turned on. Then press the arrow button pictured below to return to the live waveform image. Figure 6-5. Arrow Button to Navigate to Live Waveform Image Waveform Is Flat or Orange If the waveform is flat: 1. Wait for 30 seconds. 2. Select the Stop Waveform button and then select the Start Waveform button to restart waveform. Wait for 30 seconds after the waveform displays.
Generator Reset A generator reset can occur in response to a low generator battery or severe electromagnetic disturbance. The generator serial number is cleared by the reset and must be re-entered during the next programming session. When prompted by the generator reset screen, 1. Enter the numeric portion of the serial number which can be found in the patient’s medical records. 2. Select the Check button. a.
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Chapter 7: Warnings and Precautions This chapter contains the programmer warnings and precautions. Warnings • Do not modify this equipment without authorization of the manufacturer. • Battery capacity — The generator battery capacity can be measured using the programmer. Patients should schedule an appointment with their physician when the generator battery status displays Low or Depleted.
• The programmer is not certified for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. The consequences of using the programmer near flammable atmospheres are unknown. • Operate the system at the recommended temperature range of 5°C to 30°C (41°F to 86°F). Store it at a temperature of -20°C to 60°C (-4°F to 140°F). • Certain environments may contain particles or debris that can adhere to the tablet LCD screen.
Power Cord and Other Cables • Do not touch mains connected parts (power cords) and the patient simultaneously because of a risk of electrical shock to the patient and user. • Power cord sets used in other countries must meet the requirements of that country. Use the appropriate power cord for your locale. For information about power cord set requirements, contact Inspire Medical Systems. • Do not plug the power cord into an extension cord or multiple portable socket outlet (MPSO).
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Chapter 8: Supplemental Information This chapter describes how to maintain, clean, and service the programmer. It also includes default settings, device specifications, protected health information safeguards, regulatory information, and a description of unused tablet features. Programmer Maintenance Tablet Cleaning and Disinfecting When necessary, clean the tablet according to the following guidelines. • • • • • • Always shut down and unplug the programmer before cleaning.
Default Settings Table 8-1 lists the default values for all basic and advanced settings. Table 8-1. Default Setting Values Amplitude Setting 0.
Device Specifications Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment). Furthermore, all configurations shall comply with the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the third edition of IEC 60601-1, respectively).
Programmer Cable Table 8-3. Programmer Cable for Model 2740a Description Temperature with power on Temperature: 5°C–37°C (41°F–99°F) Humidity: 20–80% Air pressure: 697–1060 hPa (10–15.4 psi) Temperature with power off for storage or transportation Temperature: -20°C–60°C (-4°F–140°F) Humidity: RH 10–90% RH Air pressure: 187–1060 hPa (2.7–15.
Protected Health Information Introduction The following information is intended to assist customers in safeguarding electronic protected health information (ePHI) and complying with the requirements of the USA Health Insurance Portability and Accountability Act (HIPAA) Security Rule, 45 C.F.R. 165.514 and European privacy laws. This information is not intended as a comprehensive or exhaustive list of issues and recommendations.
This device complies with Part 15 of the Federal Communications Commission (FCC) Rules. 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. Class A Equipment This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules.
Electromagnetic Compatibility Declarations The Inspire Programmer (Model 2740) utilizes RF communications between the tablet and programmer cable. RF communications utilize the 2.4 to 2.485GHz ISM band and frequency shift keying modulation. Frequency-hopping spread spectrum is utilized to avoid interference with other devices. Effective radiated power from RF communications are less than 10mW.
Table 8-5. Electromagnetic Immunity The Inspire Programmer (Model 2740) is intended for use in the electromagnetic environment specified below. The customer or the user of the programmer should ensure that it is used in such an environment. Immunity Test Electrostatic discharge (ESD): EN/IEC 61000-4-2 EN/IEC 60601 Test Level Compliance Level +/-8 kV contact +/-8 kV contact +/-15 kV air +/-15 kV air Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile.
Table 8-5. Electromagnetic Immunity (continued) The Inspire Programmer (Model 2740) is intended for use in the electromagnetic environment specified below. The customer or the user of the programmer should ensure that it is used in such an environment.
Table 8-6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Inspire Programmer (Model 2740) is intended for use in the electromagnetic environment specified below. The customer or the user of the programmer should ensure that it is used in such an environment.
Table 8-6. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (continued) The Inspire Programmer (Model 2740) is intended for use in the electromagnetic environment specified below. The customer or the user of the programmer should ensure that it is used in such an environment.
Table 8-7. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Model 2740 Inspire Programmer The Model 2740 Inspire Programmer is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Unused Tablet Features The tablet has several controls, indicators, and other features that are not used by the programmer software. These features are not operational and do not affect the operation of the programmer. This section provides a brief overview of the unused features. Tablet Front The unused features on the front of the tablet (Figure 8-1) are described in Table 8-8. Figure 8-1. Unused Tablet Features, Front Table 8-8.
Tablet Right Side The unused features on the right side of the tablet (Figure 8-2) are described in Table 8-9. HDMI port SIM port Figure 8-2. Unused Tablet Features, Right Side Table 8-9.
Tablet Left Side The unused features on the left side of the tablet (Figure 8-3) are described in Table 8-10. Figure 8-3. Unused Tablet Features, Left Side Table 8-10. Unused Tablet Features, Left Side Item Audio port Function None Tablet Back The unused features on the back of the tablet (Figure 8-4) are described in Table 8-11. Camera Speaker Figure 8-4. Unused Tablet Features, Back Table 8-11.
Disposing of Programmer Do not dispose of the programmer or its components if it is no longer being used or if it becomes inoperable. It must be returned to Inspire Medical Services.
Chapter 9: Inspire Medical Systems, Inc. Limited Warranty This chapter describes the limited warranty. Inspire Medical Systems, Inc. Limited Warranty Summary Inspire provides a limited warranty against defects. The warranty period for implanted products is 3 years. All other products have a warranty period of 2 years or less. The warranty information below is intended for doctors (referred to as physicians in the warranty), but is included here for reference. Ask your doctor if you have any questions.
A. • For patient products, for example, generator, lead, Inspire Sleep Remote, Inspire Medical Systems will issue a credit to the hospital conducting replacement surgery on behalf of the original patient. Any cost reductions extended as a result of this warranty shall be fully and accurately reflected on the patients' bill and reported to that applicable payor using the appropriate methodology.
Manufacturer Inspire Medical Systems, Inc. 5500 Wayzata Blvd, Suite 1600 Golden Valley, MN 55416 USA Tel: +1-844-672-4357 +1-763-205-7970 Fax: +1-763-537-4310 www.inspiresleep.
