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Inspire 2740 Programmer's Manual

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PROGRAMMER MANUAL
Programmer Model 2740
ONLY

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Summary of Contents for Inspire 2740

  • Page 1 PROGRAMMER MANUAL Programmer Model 2740 ONLY...
  • Page 2 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.

  • Page 3: Table Of Contents

    Chapter 5: Clinical Programming Sessions 61 Introduction 61 When To Use Workflows 61 Generator Implant 61 Initial Activation 67 Follow Up 70 Sleep Study 76 Exporting a Report 81 Chapter 6: Troubleshooting 83 Communications 83 Tablet 84 Programmer Model 2740 English i...
  • Page 4 Essential Performance 99 FCC Notice (USA) 99 Electromagnetic Compatibility Declarations 101 Unused Tablet Features 107 Disposing of Programmer 110 Chapter 9: Inspire Medical Systems, Inc. Limited Warranty 111 Inspire Medical Systems, Inc. Limited Warranty 111 ii English Programmer Model 2740...

  • Page 5: Explanation Of Symbols

    Refer to the package label and device labels to see which symbols apply. Symbol Description Caution, consult accompanying documents Consult electronic instructions for use (eIFU) Consult instructions for use Nonsterile Fragile Keep dry Serial number Programmer Model 2740 English iii...
  • Page 6 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...
  • Page 7 Compliance with Underwriters Laboratories for general product safety in accordance with UL 60950-1 (ITE) and CAN/CSA C22.2 No. 60950-1 (ITE) Power button Type BF Applied part protection against electrical shock Output connector polarity Class II double insulated Programmer Model 2740 English v...
  • Page 8 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...
  • Page 9 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...
  • Page 10 English Programmer Model 2740...

  • Page 11: How To Use This Guide

    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.
  • Page 12 English Programmer Model 2740...

  • Page 13: Chapter 1: Therapy Overview

    (OSA). The implanted components of the Inspire system consist of an Inspire Generator, the Inspire Stimulation Lead, and the Inspire Respiration Sensing Lead.

  • Page 14: Intended Use

    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.
  • Page 15 Therapy settings that determine how stimulation is delivered. Therapy When therapy is turned on, the generator delivers stimulation based on the current sensing and stimulation settings. Usage The total time the patient has used Inspire therapy since the last programming session. Programmer Model 2740 English 3...
  • Page 16 The length of time that therapy is delivered once it is turned on. This should correspond to the amount of time the patient will spend asleep. Timing A term referring to the start delay, pause time, and therapy duration settings. 4 English Programmer Model 2740...
  • Page 17 A feature that switches the polarity of the sensor signal before the generator processes it for inhalations and exhalations. This feature could be used to correct a situation in which stimulation is being delivered during exhalation instead of inhalation. Programmer Model 2740 English 5...
  • Page 18 Note: This is an advanced setting. Respiratory period The generator measures the respiratory period from exhalation to exhalation. The respiratory period is used for the calculation of the off period. 6 English Programmer Model 2740...

  • Page 19: 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.
  • Page 20 When the programmer communicates with the generator, a large communication icon displays (Figure 1-4). The color of this icon corresponds to the connection status: blue indicates different levels of communication success and orange indicates communication failure. Figure 1-4. Communication Screen 8 English Programmer Model 2740...

  • Page 21: Chapter 2: Programmer Components

    Tablet The tablet screen is controlled by the user with the touchscreen. The Inspire system uses the buttons and controls that are specified in this programming guide. Some of the buttons and controls on the tablet are not used when programming the Inspire system.
  • Page 22 LCD screen Status lights Figure 2-1. Tablet Front Table 2-1. Tablet Front Icon/Item Description Function Status lights WiFi Charging Power Docking connector Interface connector for use with docking station (not included) 10 English Programmer Model 2740...
  • Page 23 Table 2-2. Tablet Status Lights Light Status Description WiFi Green N/A - WiFi not used Charging Red (solid) Charging Fully charged Red (flashing) Abnormal charging condition Power Blue System ON Yellow Standby (unused) Programmer Model 2740 English 11...
  • Page 24 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 Left Side 12 English Programmer Model 2740...
  • Page 25 A medical-grade tablet power supply provides power to the tablet and charges the battery. A power cord is included. Warning: Use only the tablet power supply provided with the tablet. Do not use the tablet power supply to power any other electronic devices. Programmer Model 2740 English 13...

  • Page 26: Data Backup Kit

    (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. Programmer Cable Data Backup Kit The included USB flash drive allows the user to download and back up session reports. Figure 2-6. Data Backup Kit 14 English Programmer Model 2740...
  • Page 27 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. Portability Kit Programmer Model 2740 English 15...
  • Page 28 16 English Programmer Model 2740...

  • Page 29: Chapter 3: Getting Started

    1. Open the cover on the tablet power adaptor port and insert the single-prong end of the tablet power supply cable into the tablet. 2. Insert the power cord into the tablet power supply. 3. Insert the end of the power cord into the electrical outlet (100–240 VAC). Programmer Model 2740 English 17...
  • Page 30 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. Tablet Power Button 18 English Programmer Model 2740...
  • Page 31 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). Figure 3-3. Programmer Cable Power Supply Connections Programmer Model 2740 English 19...

  • Page 32: Starting A Session

    Starting a Session Navigating the Start Screen Once the programmer is powered on, the Start screen displays (Figure 3-4). Figure 3-4. Start Screen 20 English Programmer Model 2740...
  • Page 33 Important status notifications appear at the bottom of the Start screen along with the current date and time (Figure 3-5). Current date and time Programmer cable status Programmer battery status appears here Figure 3-5. Start Screen Footer Information Programmer Model 2740 English 21...
  • Page 34 The current date and time display in the lower-right corner of all programming screens as follows. • Current date — Displays on all screens in a DD Month YYYY format. • Current time — Displays on all screens in a 24-hour format. 22 English Programmer Model 2740...

  • Page 35: Using The Touch Screen

    5. Set the appropriate number format for your region. 6. Set the programmer cable lighting mode. Day mode will enable all lights on the programmer cable and night mode will disable lights for nighttime use. After modifying programmer settings select the Save button. Programmer Model 2740 English 23...
  • Page 36 • 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.
  • Page 37 – remove the source of interference. 7. Select the Done button when the programmer head is positioned properly and the communication strength has reached a rating of good shown in Table 3-2. Table 3-2. Communication Strength Ratings Good Moderate Programmer Model 2740 English 25...
  • Page 38 After testing the connection, maintain the good programmer head position and select the Connect to Generator button on the Start screen. As the programmer connects to the generator, the tablet displays one or more of the following Communication Screens described in Table 3-3. If necessary, take the recommended actions. 26 English Programmer Model 2740...
  • Page 39 Figure 3-8. Communication Screen Table 3-4 describes common problems associated with establishing a wireless connection between the tablet, programmer cable, and generator along with their solutions. Programmer Model 2740 English 27...
  • Page 40 1. Ensure that the tablet is on. 2. Select the Demo button from the Start screen. Note: Demonstration Mode is displayed in the programmer cable status line located in the lower-left corner of the tablet screen. 28 English Programmer Model 2740...

  • Page 41: Exiting A Session And Turning Off The Programmer

    5. To disconnect the tablet power supply from mains power, unplug the power cord from the electrical outlet. Note: The programmer is not designed for use over extended periods of time (>24 hours) without restarting. Programmer Model 2740 English 29...
  • Page 42 30 English Programmer Model 2740...

  • Page 43: Chapter 4: Screen Descriptions

    • De-ID — Deidentified ID, an anonymous identifier assigned to the patient for use when confidentiality is required. • Serial Number — Generator serial number. • Home/Back Button — Select button to access the Home screen or the previous screen visited. Programmer Model 2740 English 31...
  • Page 44 All programmer screens also display common information in the screen footer. (Figure 4-3): Programmer cable status Current date and time Programmer battery status appears here if capacity is low Figure 4-3. Common Information in Screen Footer 32 English Programmer Model 2740...
  • Page 45 The current date and time display in the lower-right corner of all programming screens as follows. • Current date — Displays on all screens in a DD Month YYYY format. • Current time — Displays on all screens in a 24-hour format. Programmer Model 2740 English 33...

  • Page 46: Start Screen

    Demo • Starts a practice programming session. • Makes it possible to practice using the programmer with a simulated generator when a patient is not present. 34 English Programmer Model 2740...

  • Page 47: 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. Programmer Model 2740 English 35...

  • Page 48: Home Screen

    Home Screen Figure 4-6. Home Screen The Home screen (Figure 4-6) is divided into five sections: • Therapy Status • Workflows • Setting Summary • Patient Details • Advanced Tools 36 English Programmer Model 2740...
  • Page 49 Figure 4-7. • Usage — The number of hours Inspire therapy has been used since the last programming session. The average usage per week also displays in parentheses.
  • Page 50 – Not Performed indicates activity has not been started. – Started indicates the Initial Activation workflow has been started but not fully completed. – Done with a check mark indicates activity has been completed (Figure 4-8). Figure 4-8. Action Status Indicators 38 English Programmer Model 2740...

  • Page 51: Settings Summary

    Patient information can be updated at any time by selecting the Patient Details button, which accesses the Patient Details screen (see the following section). Advanced Tools This option is hidden by default. When the dropdown arrow is selected, three additional activities are available to the user if desired. Programmer Model 2740 English 39...

  • Page 52: System Check

    • 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. 40 English Programmer Model 2740...

  • Page 53: Patient Details Screen

    Note: The ability to edit the Patient Name and Patient ID fields is controlled from the Programmer Settings screen (Patient Information Storage). Programmer Model 2740 English 41...

  • Page 54: On-Screen Keyboard

    • Sense Lead Model Number — Enter the model number of the sensing lead. • Sense Lead Serial Number — Enter the serial number of the sensing lead. • Sense Lead Location — Enter the location of the sensor in the body. 42 English Programmer Model 2740...

  • Page 55: Adjust Stimulation Screen

    The difference will remain constant as the limit values track changes in the amplitude. • Review flags indicate that the patient has changed the amplitude value, and thus the amplitude values should be reviewed. Programmer Model 2740 English 43...

  • Page 56: Programming Buttons

    Testing stimulation will not change the current generator settings. • During test stimulation, the generator delivers stimulation for the duration of the maximum stimulation time. • It is recommended to test stimulation with the therapy off. 44 English Programmer Model 2740...
  • Page 57 • Default Settings — Selects the default stimulation settings. See “Default Settings” on page 96 for more information. Stim History Select the Stim History button to access stimulation levels and settings stored in the programmer from earlier in the session or from previous sessions. Programmer Model 2740 English 45...
  • Page 58 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. • Select the Configure button to configure the generator with all displayed settings that differ from the current generator settings. 46 English Programmer Model 2740...
  • Page 59 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.
  • Page 60 Table 4-3. Electrode Options Default electrode 48 English Programmer Model 2740...

  • Page 61: Adjust Sensing Screen

    • Hard Off Period Select the Invert Signal box to invert the sensor signal before it is processed. See Table 1-3 on page 5 for more information about the terminology and settings used on this screen. Programmer Model 2740 English 49...
  • Page 62 • Select Cancel button to return to Adjust Sensing screen without saving the waveform. • Select Save button to add an image of the waveform and any selected labels to the session report. Note: The Screenshot button is disabled until the Start Waveform button has been selected. 50 English Programmer Model 2740...
  • Page 63 • When therapy is turned on or setting changes are made with the therapy on, the generator needs approximately 3 minutes to resynchronize with respiration. For this reason, it is recommended to make changes only after observing therapy performance for 3–5 minutes. Programmer Model 2740 English 51...
  • Page 64 • Select Check Pressure button to measure the current peak-to-peak sensor pressure. Measurement results are most accurate when the sensing has been allowed to synchronize with the patient’s respiration for several minutes. Note: This button is enabled only when therapy is on. 52 English Programmer Model 2740...

  • Page 65: Select A Patient Screen

    Note: A sample patient named John Doe may appear on this screen and is associated with all demonstration mode reports. Refer to Table 4-4 for information about the functions of the buttons on the Select a Patient screen. Programmer Model 2740 English 53...
  • Page 66 Delete button, reports for all patients will be deleted. Export patient reports to Attach the Inspire USB flash drive to the tablet. external USB flash drive • Highlight patient name and select the Export button to display Export Report screen (Figure 4- 22).

  • Page 67: Reports Screen

    Figure 4-20. Delete Report Screen Reports Screen Figure 4-21. Reports Screen Programmer Model 2740 English 55...
  • Page 68 Select the Show Settings or Hide Settings button. displayed waveform View additional waveform Select the right or left arrow buttons above the waveform image. screenshots Note: If arrow buttons are disabled, there are no additional screenshots to view. 56 English Programmer Model 2740...
  • Page 69 • Select Delete button to confirm that you wish to permanently remove the selected report(s). Export session report to Attach the Inspire USB flash drive to the tablet. external USB flash drive • Highlight report and select the Export button to display Export Report screen (Figure 4-22).
  • Page 70 Figure 4-22. Export Report Screen 58 English Programmer Model 2740...

  • Page 71: Stimulation History Screen

    View additional sets of recorded Select the right or left arrow buttons in the levels section of the stimulation levels screen. Note: If arrow buttons are disabled, there are no additional levels to view. Programmer Model 2740 English 59...

  • Page 72: Sensing History Screen

    Reports screen. View the next or previous set of dates Select the left and right arrow buttons at the top of the screen. Note: If arrow buttons are disabled, there are no additional dates to view. 60 English Programmer Model 2740...

  • Page 73: Chapter 5: Clinical Programming Sessions

    • Assess Sensor Performance • End Session • Retain Records Start Session With the generator still in its sterile box, follow the steps for “Turning On the Programmer” on page 17 and “Starting a Session” on page 20. Programmer Model 2740 English 61...
  • Page 74 Note: The ability to edit the Patient Name and Patient ID fields is controlled from the Programmer Settings Screen (Patient Information Storage). Check Generator Status Verify that the generator battery status is good. 62 English Programmer Model 2740...
  • Page 75 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. Check Workflow Screen Programmer Model 2740 English 63...
  • Page 76 Select Anesthetized under the Sleep Type labels. Additional labels may be selected if desired. b. Select the Save button to save the displayed waveform in the session report. 5. Select the Next Step button. Stimulation and the real-time waveform will stop. 64 English Programmer Model 2740...

  • Page 77: 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. Select the Done button to complete the workflow. Figure 5-5. System Check - Summary Screen Programmer Model 2740 English 65...

  • Page 78: End Session

    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. End Implant Session - Home Screen 66 English Programmer Model 2740...

  • Page 79: Initial Activation

    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 •...
  • Page 80 4. If necessary, repeat step 3 until a comfortable amplitude is achieved. 5. Select the Screenshot button to annotate and save the displayed waveform in the session report. 6. Select the Next Step button. Note: This will stop stimulation and the real-time waveform. 68 English Programmer Model 2740...
  • Page 81 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. Initial Activation - Stimulation Summary Screen Programmer Model 2740 English 69...

  • Page 82: Follow Up

    Review the information displayed in the Therapy Status section of the Home screen. Note usage hours and any amplitude changes that the patient has made since the last visit, which are indicated by gold change flags. Talk to the patient to assess how effectively the patient is using the therapy. 70 English Programmer Model 2740...
  • Page 83 Note: Pay attention to any Review flags that may appear. 2. Make desired changes using the arrows. 3. If there are any new settings to program in the generator, select the Configure button. 4. Select the Done button. Programmer Model 2740 English 71...
  • Page 84 9. Repeat steps 2-7 for the new electrode selection. 10. If desired, select additional electrodes for evaluation and repeat steps 2-7 for each selection. 11. Select the Next Step button. 72 English Programmer Model 2740...
  • Page 85 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. Advanced Follow Up - Select Electrode and Amplitude Screen Programmer Model 2740 English 73...
  • Page 86 1. Review the level and tongue motion data that was saved on the previous screen. 2. Select the desired pulse width/rate option. 3. Select the desired stimulation level if two levels are available. Note: Therapy Amplitude is equivalent to the “Similar to Current Therapy” level. 74 English Programmer Model 2740...
  • Page 87 1. Confirm that therapy is turned off. 2. Review the Settings Summary and confirm desired changes. 3. Confirm that the Follow Up Workflow has been completed. 4. Select the Exit button on the Home screen. Programmer Model 2740 English 75...

  • Page 88: Sleep Study

    2. Select the Test Connection button from the tablet or the programmer cable. 3. Move programmer head around implanted generator to find best location for a good signal strength considering all sleep positions. Monitor the strength gauge on the tablet screen or programmer head. 76 English Programmer Model 2740...
  • Page 89 The amplitude will return to its starting value when the sleep study is ended or when the workflow is exited. 5. Select the Next Step button. 6. If desired, change the programmer cable lights mode. Programmer Model 2740 English 77...
  • Page 90 Amplitude, and wait for the patient to fall back asleep. Note: Changes to the amplitude, therapy on/off state, and advanced stimulation settings will be logged and can be reviewed during the study. 3. Once the sleep study is completed, select the End Study button. 78 English Programmer Model 2740...
  • Page 91 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. Sleep Study - Stimulation Settings Summary Screen Programmer Model 2740 English 79...
  • Page 92 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. 80 English Programmer Model 2740...

  • Page 93: Exporting A Report

    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.
  • Page 94 82 English Programmer Model 2740...

  • Page 95: Chapter 6: Troubleshooting

    3. If the patient’s remote cannot communicate with the generator either, wait 24 hours and try using the patient’s remote again to turn off therapy. 4. If still unsuccessful, the generator may need to be replaced. Contact Inspire Medical Systems. Programmer Model 2740...

  • Page 96: Tablet

    9. If these steps do not resolve the problem, confirm that the programmer serial number (e.g., 101) displays on the Programmer Settings screen. 10. If the programmer serial number does not display, use a different programmer and call Inspire Medical Systems.

  • Page 97: Programmer Cable - Error Mode

    1. Select the Settings button on the Start Screen. 2. Choose the correct language from the drop-down menu. 3. Select the Save button. Refer to Figure 6-3 to locate these buttons if you cannot read the programmer screens. Programmer Model 2740 English 85...

  • Page 98: Therapy

    (See "Exiting a Session and Turning Off the Programmer" on page 29 for more information.) • Never let a patient leave after a forced programmer shutdown until you reconnect to the generator and confirm the generator settings. 86 English Programmer Model 2740...
  • Page 99 • A measured impedance < 200 ohms may indicate a short between lead conductors preventing stimulation from reaching the patient. • Additionally, certain combinations of impedance results may indicate a problem. These will be flagged as abnormal if they occur. Impedance values should be considered for information only. Programmer Model 2740 English 87...

  • Page 100: Waveforms

    Impedance values greater than 2000 ohms are outside the generator measurement range and should be considered for information only. Certain combinations of impedance results may be flagged as abnormal. Repeat the measurement; and, if the flagged results persist, contact Inspire Medical Systems. 88 English Programmer Model 2740...

  • Page 101: Generator Reset

    If the Export button is disabled, select the Enable USB Report Export check box on the Programmer Settings screen. Export Failure Screen If an export failure screen displays, follow these steps: 1. Disconnect the Inspire USB flash drive from the tablet. 2. Reconnect the Inspire USB flash drive to the tablet. 3. Wait 30 seconds and retry export.
  • Page 102 90 English Programmer Model 2740...

  • Page 103: Chapter 7: Warnings And Precautions

    • Do not place the system components in direct sunlight or next to equipment that generates heat. This can damage the programmer and may generate heat or fire. • Do not use the Model 2740 power supplies for other equipment. This can generate heat or fire. In addition, do not use other power supplies with the system.
  • Page 104 • Do not open or attempt to service this product. Opening or servicing the system components can result in electric shock. • Restrict access to the Model 2740 to authorized users as the tablet does not provide user authentication. Tablet Wi-Fi and general-purpose Bluetooth functionality are disabled, therefore network security controls such as firewalls are not required.

  • Page 105: Power Cord And Other Cables

    • Do not use or leave the tablet and its battery pack near a heat source. Heat can melt the insulation and damage other safety features, possibly causing it to leak, overheat, emit smoke, burst and/or ignite. Programmer Model 2740 English 93...
  • Page 106 94 English Programmer Model 2740...

  • Page 107: Chapter 8: Supplemental Information

    Servicing Programmer The system has been carefully engineered, manufactured, and tested to provide trouble-free service. Contact Inspire Medical Systems if service or repair is required. Contact information is printed on the back cover of this programming guide. If possible, please ship the programmer back to Inspire Medical Systems in its original shipping container. If the original container is not available, contact Inspire Medical Systems regarding packaging the programmer for shipment.

  • Page 108: Default Settings

    Exhalation threshold Hard off period Inhalation sensitivity Inhalation threshold Invert signal Maximum stimulation time Patient control Pause time 15 m Pulse width 90 μs Rate 33 Hz Soft off period Start delay 30 m Therapy duration 96 English Programmer Model 2740...

  • Page 109: Device Specifications

    Anyone connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Local laws take priority over the requirements mentioned above. Contact Inspire Medical Systems with any questions.
  • Page 110 Programmer Cable Table 8-3. Programmer Cable for Model 2740 Description Specifications 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 Temperature: -20°C–60°C (-4°F–140°F) transportation Humidity: RH 10–90% RH Air pressure: 187–1060 hPa (2.7–15.4 psi)

  • Page 111: Protected Health Information

    Inspire Programmer (Model 2740) The Inspire Programmer (Model 2740) retains in memory all patient identifiers and data entered during a programming session. The option not to store PHI is available on the Programmer Settings screen. Disable (uncheck) the Patient Information Storage feature if you do not want PHI to be stored.

  • Page 112: Class A Equipment

    Cables Only Inspire Medical Systems provided cables should be used with the Inspire system. Use of other cables may result in unacceptable interference with other devices or the programmer itself might become more vulnerable to interference from other devices.

  • Page 113: Electromagnetic Compatibility Declarations

    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.
  • Page 114 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 EN/IEC 60601 Test...
  • Page 115 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. Immunity Test...
  • Page 116 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.
  • Page 117 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.
  • Page 118 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. The customer or the user of the programmer can...

  • Page 119: Unused Tablet Features

    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. Unused Tablet Features, Front Item Function Function button None WiFi Light Indicates WiFi connection (unused) Programmer Model 2740 English 107...
  • Page 120 The unused features on the right side of the tablet (Figure 8-2) are described in Table 8-9. HDMI port SD port SIM port Figure 8-2. Unused Tablet Features, Right Side Table 8-9. Unused Tablet Features, Right Side Item Function HDMI port None SIM port None SD port None 108 English Programmer Model 2740...
  • Page 121 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. Unused Tablet Features, Back Item Function Camera None Speaker None Programmer Model 2740 English 109...

  • Page 122: Disposing Of Programmer

    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. 110 English Programmer Model 2740...

  • Page 123: Chapter 9: Inspire Medical Systems, Inc. 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.
  • Page 124 2. For implantable products, this limited warranty applies only for a product replacement in the original patient. 3. All registration materials must be completed and returned to Inspire Medical Systems within 30 days of first use. 4. The product must be replaced with an Inspire Medical Systems product.
  • Page 126 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.com © Inspire Medical Systems 2020 All Rights Reserved 200-349-101 Rev A...

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