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1 | User Manual | Users Manual | 4.35 MiB | February 10 2021 / August 08 2021 | delayed release |
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.
Explanation of Symbols on Package Labeling and Device iii
TABLE OF CONTENTS
Explanation of Symbols 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
Chapter 5: Clinical Programming Sessions 61
Common Screen Elements 31
Start Screen 34
Programmer Settings Screen 35
Home Screen 36
Patient Details Screen 41
Adjust Stimulation Screen 43
Adjust Sensing Screen 49
Select a Patient Screen 53
Reports Screen 55
Stimulation History Screen 59
Sensing History Screen 60
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
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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
Chapter 9: Inspire Medical Systems, Inc. Limited Warranty 111
Inspire Medical Systems, Inc. Limited Warranty 111
ii
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Programmer Model 2740
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
Caution, consult accompanying documents
Consult electronic instructions for use (eIFU)
Consult instructions for use
Nonsterile
Fragile
Keep dry
Serial number
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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
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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. 60950-1 (ITE)
Power button
Type BF Applied part protection against electrical shock
Output connector polarity
Class II double insulated
Programmer Model 2740
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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
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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
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viii
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Programmer Model 2740
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.
• Getting Started
This chapter provides instructions on how to set up and start the programmer and how to start and end
a programming session.
• Screen Descriptions
• Clinical Programming Sessions
This chapter provides detailed descriptions of the programmer screens.
This chapter provides instructions for programming procedures (workflows) at implant, initial
activation, follow up, and sleep studies.
This chapter contains solutions to problems that may be encountered during programmer use.
• Troubleshooting
• Warnings and Precautions
• Supplemental Information
This chapter provides programmer warnings and precautions.
This chapter provides general reference information, such as device specifications and proper
procedures for cleaning, servicing, and maintaining the programmer. This chapter also includes HIPPA
and regulatory information.
• Limited Warranty
This chapter describes the device limited warranty. This warranty applies only in the United States.
Areas outside the United States should contact an Inspire Medical Systems representative for exact
warranty terms.
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x
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Programmer Model 2740
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).
The implanted components of the Inspire system consist of an Inspire Generator, the Inspire Stimulation Lead, and
the Inspire Respiration Sensing Lead.
The implanted system is programmed using the Inspire programmer. The patient uses a patient remote to turn
therapy on and off and to temporarily pause stimulation. Patients may also be allowed the option of adjusting the
strength of stimulation within a selected range.
Stimulation lead
Generator
Sensing lead
Figure 1-1. Inspire System Implanted Components
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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.
Implant Procedure
During this procedure, the generator, stimulation lead, and sensing lead are surgically implanted. The Inspire
programmer is used to test the implanted system during surgery.
Therapy Acclimation
Therapy acclimation typically lasts for 1–3 months following implantation. During this phase, the device is
activated and patients learn how to use the patient remote to increase the amplitude to a therapeutic level.
Titration
During this phase, patients undergo 1–2 polysomnograms (PSGs) or sleep studies, during which the physician
determines the optimal stimulation and sensing settings.
Therapy Maintenance
On an annual or semi-annual basis, patients return for an office visit to monitor therapy use and efficacy.
Titrations are performed as needed.
Terminology
This section introduces and defines common terms used throughout this programming guide for setting the
setting values, reading on-screen information, and evaluating patient responses. More information about these
terms will be presented in later chapters.
The definitions are divided into the following three categories.
• General Therapy Terms
• Stimulation Settings
• Sensing Settings
Settings that appear on the advanced screen views are labeled as advanced settings in the definitions that follow.
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General Therapy Terms
Table 1-1 defines general therapy terms related to Inspire therapy.
Term
Current generator
settings
Functional level
Impedance
Table 1-1. General Therapy Terms
Definition
The stimulation and sensing settings currently used by the generator.
The combined stimulation and sensing settings are also known as the
therapy settings.
Lowest amplitude at which a significant tongue motion is observed, such
as the tongue protruding past the lower teeth.
The resistance to the flow of stimulation energy. Impedance
measurements can be used to assess the integrity of leads, lead
electrodes, and the lead–generator connection.
Default settings
Default therapy settings determined by the generator manufacturer.
Initial session settings
The therapy settings at the start of the current programming session.
Generator
Inspire generator.
Generator battery status
The current state of the generator battery. If the battery status is Low or
Depleted, schedule a generator replacement procedure.
Sensation level
The lowest amplitude at which a patient can feel stimulation.
Sensing
Defines how the generator determines inhalation and exhalation in
order to time the delivery of stimulation.
Sensing settings
Therapy settings that determine when the generator delivers
stimulation.
Session
(programming session)
A series of interactions between the Inspire programmer and generator
during which the therapy settings are reviewed and/or modified.
Stimulation (Stim)
Mild electrical signals delivered to the hypoglossal nerve to elicit a
neuromuscular response at the base of the tongue and to maintain
airway patency.
Stimulation settings
Therapy settings that determine how stimulation is delivered.
Therapy
Usage
When therapy is turned on, the generator delivers stimulation based on
the current sensing and stimulation settings.
The total time the patient has used Inspire therapy since the last
programming session.
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Stimulation Setting Terms
Table 1-2 defines terms related to stimulation settings.
Term
Amplitude
Electrode
configuration
Pause time
Pulse width
Table 1-2. Stimulation Setting Terms
Definition
The stimulation level measured in volts. Increasing amplitude will increase
stimulation strength; decreasing amplitude will decrease stimulation
strength.
The electrodes and polarities used to deliver the stimulation.
Note: This is an advanced setting.
Patient amplitude
control
This feature allows the patient to use the patient remote to adjust the
stimulation amplitude within predefined limits set by the physician.
The length of time that the patient is allowed to suspend therapy if
needed during the night.
The stimulation pulse duration. Increasing pulse width will increase
stimulation strength; decreasing pulse width will decrease stimulation
strength.
Note: This is an advanced setting.
Rate
Number of stimulating pulses delivered per second. Increasing rate will
increase stimulation strength; decreasing rate will decrease stimulation
strength.
Note: This is an advanced setting.
Start delay
The period between the time the patient activates the therapy for the
night and the time stimulation begins. This interval allows the patient to
fall asleep before therapy starts.
Therapy duration
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.
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Sensing Setting Terms
Table 1-3 defines terms related to sensing settings.
Term
Exhalation
Exhalation sensitivity
Exhalation threshold
Inhalation
Inhalation sensitivity
Table 1-3. Sensing Setting Terms
Definition
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. When therapy is turned on, the
generator starts to deliver stimulation when it determines that inhalation has
occurred, and it stops stimulation when it determines that exhalation has
occurred or when the maximum stimulation time expires.
This setting determines at what speed (slope) of decrease in the sensor signal the
generator will detect an exhalation. Increasing exhalation sensitivity configures
the generator to detect exhalations on more gradual decreases in the sensor
signal; decreasing exhalation sensitivity configures the generator to only detect
exhalations on more rapid decreases in the sensor signal.
This setting controls the height that the sensor signal must reach before the
generator will attempt to detect an exhalation. Increasing the exhalation
threshold causes the generator to look for exhalations more often; decreasing the
exhalation threshold decreases how often the generator looks for exhalations.
This setting allows for the management of signal artifacts that can cause the
generator to detect extraneous exhalations.
Note: This is an advanced setting.
The start of inhalation as determined by the generator. The generator detects that
inhalation has occurred when an increase in the sensor signal meets the inhalation
sensitivity and threshold criteria. When therapy is turned on, the generator starts
to deliver stimulation when it determines that inhalation has occurred, and it
stops stimulation when it determines that exhalation has occurred or when the
maximum stimulation time expires.
Inhalation sensitivity determines at what speed (slope) of increase in the sensor
signal the generator will detect an inhalation. Increasing inhalation sensitivity
configures the generator to detect inhalations on more gradual increases in the
sensor signal; decreasing inhalation sensitivity configures the generator to only
detect inhalations on more rapid increases in the sensor signal.
Note: This is an advanced setting.
Inhalation threshold
This setting controls the height that the sensor signal must reach before the
generator will attempt to detect an inhalation. Increasing the inhalation threshold
causes the generator to look for inhalations more often; decreasing the inhalation
threshold decreases how often the generator looks for inhalations.
Note: This is an advanced setting.
Invert signal
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.
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Term
Definition
Table 1-3. Sensing Setting Terms
Maximum
stimulation time
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.
Off period (Soft)
A percentage of the respiratory period during which the generator may detect an
inhalation if the sensitivity and threshold criteria are met. When the soft off
period expires, only inhalation sensitivity criteria is used to detect inhalation. The
soft off period occurs during the final portion of the hard off period.
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.
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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. Electrode Icons
Icon
Description
Negative lead electrode
Positive lead electrode
Unused (off) lead electrode
Positive generator case electrode
Unused (off) generator case electrode
These icons are used to indicate the polarity of all system electrodes. For example, the default electrode is shown
in Figure 1-2.
Outer electrode
Center electrode
Figure 1-2. Default Electrode
Case electrode
In this configuration, the three square lead electrode icons indicate that the outer electrode is positive and the
center electrode is negative. The round, filled-in case electrode indicates that the electrode is off and not used in
this configuration.
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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). 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
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Programmer Model 2740
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.
• Tablet
– Handheld computer
– Inspire programmer software
– Medical-grade power supply and power cord
• Programmer cable
– Programmer head
– Bluetooth wireless communications interface
– Medical-grade power supply and power cord
• Inspire universal serial bus (USB) flash drive
• Portability kit
– Inspire computer bag
– Luggage tag
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.
Tablet Front and Bottom
The front of the tablet (Figure 2-1) contains an LCD screen and status lights. The status lights and docking
connector are described in Table 2-1 and Table 2-2. Unused controls are listed in Chapter 8.
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LCD screen
Status lights
Icon/Item
Description
Function
Figure 2-1. Tablet Front
Table 2-1. Tablet Front
Status lights
WiFi
Charging
Power
Docking connector
Interface connector for use
with docking station (not
included)
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Table 2-2. Tablet Status Lights
Light
Status
Description
WiFi
Green
N/A - WiFi not used
Charging
Red (solid)
Charging
Off
Fully charged
Red (flashing)
Abnormal charging condition
Power
Blue
Yellow
System ON
Standby (unused)
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The right side of the tablet (Figure 2-2) contains the USB port. Unused controls are listed in Chapter 8.
Tablet Right Side
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
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Programmer Model 2740
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. Do not puncture, short, or expose it to fire
or water.
Tablet Power Supply
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.
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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 2-
5). 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
Data Backup Kit
The included USB flash drive allows the user to download and back up session reports.
Figure 2-5. Programmer Cable
Figure 2-6. Data Backup Kit
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Programmer Model 2740
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
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Programmer Model 2740
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.
Charging Status
The battery status light that is located on the front, upper-right corner of the tablet (see Figure 2-1) indicates the
charging status of the battery.
• Steady red — The battery is charging.
• Off — The battery is fully charged.
Note: In storage, the battery slowly self-discharges. If the tablet is not used regularly, plug it into an electrical
outlet for 2 hours every 4 weeks to maintain the battery charge.
Charging Battery
The battery automatically charges to full capacity while the tablet is powered by an electrical outlet. The tablet
does not need to be on to charge the battery. The battery should be fully charged prior to storing the programmer.
Only charge the battery when its temperature is between 0°C and 40°C. If the battery has been subjected to
extreme temperatures, wait until it cools to room temperature before recharging.
Connecting Tablet to Power
To connect the tablet to an electrical outlet (Figure 3-1):
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.
Insert the power cord into the tablet power supply.
Insert the end of the power cord into the electrical outlet (100–240 VAC).
2.
3.
Programmer Model 2740
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1
3
2
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. Tablet Power Button
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Programmer Model 2740
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. Programmer Cable Power Supply Connections
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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
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Programmer Model 2740
The buttons on the Start screen are described in Table 3-1.
Button
Connect to Generator
Table 3-1. Start Screen Button Descriptions
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
Reports
Settings
Demo
generator and is used to determine best position for
programmer cable and head.
Note: Button is disabled until the tablet has established a
connection to the programmer cable.
• Accesses reports for previous programming sessions.
• Reports can be reviewed and exported.
• Accesses the Programmer Settings screen; allows access to
data management controls and adjustments to date and time,
language, number format, and programmer cable mode.
• Starts a practice programming session.
• Makes it possible to practice using the programmer with a
simulated generator when no patient is present.
Shut Down
• Powers off the tablet.
Programmer Cable
Lights Mode
• Day mode uses full lighting.
• Night mode turns visible lights off and activates infrared
lighting.
Important status notifications appear at the bottom of the Start screen along with the current date and time
(Figure 3-5).
Programmer cable status
Programmer battery status appears here
Current date and time
Figure 3-5. Start Screen Footer Information
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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. Status background color is white with pulsing border. Controller status light is partially lit
(see Figure 3-5). Communication buttons are disabled.
• Demo Mode — Wireless link between tablet and programmer cable is not active, but programmer may
be used for demonstration. Status background color is pink.
Programmer Battery Status
The programmer battery status displays one of the following messages in the bottom-center of all screens if
the battery is low or depleted.
• Battery Low — The programmer battery is nearing depletion and should be connected to power supply
• Recharge Battery — The programmer must be attached to the power supply to prevent an automatic
soon.
shutdown.
Current Date and Time
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.
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Programmer Model 2740
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. Select the Settings button from the Start screen.
2. Set data control options.
3. Set the correct date and time.
4. Set the language to your native language.
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.
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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.
name and ID.
• Patient Information Storage — Select this check box to enable or disable the storage/editing of patient
• Patient Information Export — Select this check box to enable or disable the exporting of patient details.
Select the Save button to save the new data control settings.
Setting Language
1. Select the Settings button from the Start screen.
2. Select the Language menu and choose one of the languages.
3. Select the Save button to save the new language.
Setting Number Format
1. Select the Settings button from the Start screen.
2. Select the Number Format drop-down menu and choose one of the formats that displays below.
3. Select the Save button to save the new number format.
Setting Date and Time
1. Select the Settings button from the Start screen.
2. Select the arrow buttons to adjust the day, month and year.
3. Select the arrow buttons to adjust the 24-hour clock.
4. Select the Save button to save the new date and time.
Note: The programmer does not automatically adjust for daylight savings time. Manually update the date
and time when local time changes occur.
Positioning Programmer Head and Connecting to Generator
The programmer head must be properly positioned over the generator to establish the signal strength required
to connect to the generator.
Confirming Connection
The programmer cable status line in the lower-left corner of the screen will indicate that a communication
link between the tablet and the programmer cable is established. See “Programmer Cable Status” on
page 22“ for more information.
A fully lit status light displays on the programmer cable controller when the tablet and programmer cable
establish a connection.
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Programmer Model 2740
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. Ensure the programmer cable is connected to power.
2. Position the programmer head directly over the generator (Figure 3-7).
3. Press the Test Connection button on the controller.
4. The strength gauge will display one of the following ratings in Table 3-2.
5.
If signal strength is not good, reposition the programmer head directly over the generator for a
stronger signal or remove the source of interference.
6. Wait 30 seconds for the process to end or press the Test Connection button, again, to cancel.
Starting the process from the tablet:
1. Ensure that the tablet and programmer cable are on.
2. Confirm that a wireless link between the tablet and programmer cable has been established by
checking the programmer cable status line in the screen footer.
3. Position the programmer head directly over the generator (Figure 3-7).
4. Select the Test Connection button on the Start screen or on a screen within a programming session.
5. The screen will display one of the following strength ratings shown in Table 3-2.
6.
If signal strength is not good, follow the on-screen instructions:
– reposition the programmer head directly over the generator for a stronger signal, or
– 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
Low
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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.
Note: The programmer head strength gauge will illuminate whenever communication is active, not just when
testing the connection.
Connecting to Generator
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.
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Table 3-3. Communication Screens
Message
Event
Action
Connecting to generator
Wait for connection to be established.
Configuring generator
Wait for connection to be established.
Generator Not Found or
Electrical Interference
Reposition programmer head over generator
or remove source of interference. After 30
seconds of communication failure, the Exit
Session button is available to end the current
session.
A large communication icon displays on all Communication Screens (Figure 3-8). The icon corresponds to the
programmer head status light to indicate communication success or failure.
Displays when the
Connect to Generator
button has been selected.
Displays when the
generator is being updated
for the start of a session.
Displays when the
programmer head is not
correctly positioned over
the generator.
Table 3-4 describes common problems associated with establishing a wireless connection between the tablet,
programmer cable, and generator along with their solutions.
Figure 3-8. Communication Screen
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Table 3-4. Communications Troubleshooting
Problem
No Connection Between Tablet
and Programmer Cable
Action
Ensure that the tablet is within wireless range. Move tablet closer
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.
Ensure tablet is within wireless range to establish connection and
enable all communication buttons.
Generator Not Found
Reposition programmer head directly over generator.
Electrical Interference
Remove cause of interference and reposition programmer head
directly over generator. Electrical equipment, such as inductive
plethysmography, CRT monitors, and electrical power supplies are
possible causes of interference.
Using Demonstration Mode
Use Demonstration Mode to practice using the programmer with a simulated generator. The programmer cable
is not needed for Demo Mode.
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.
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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. Select the Exit button to end the session and display the Start screen.
3. Select the Shut Down button to power off the tablet.
Note: The tablet will continue to charge when powered off and should be fully charged before storing. The
charging light will turn off when the tablet is fully charged.
4. To power off the programmer cable and disconnect it from mains power, unplug the power cord from the
5. To disconnect the tablet power supply from mains power, unplug the power cord from the electrical
electrical outlet.
outlet.
Note: The programmer is not designed for use over extended periods of time (>24 hours) without restarting.
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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. This means that
therapy is being delivered or will be delivered once the start delay or pause time has expired.
When the therapy is off, the therapy status displays Therapy is Off. This means therapy is not being
delivered and will not be delivered until a therapy on command is received by the generator.
• Turn On/Turn Off Therapy Button — Select button to turn stimulation on or off. Turning stimulation on
accesses the Start Therapy screen (Figure 4-2), where you may choose to start therapy immediately or
postpone until the start delay expires.
• Patient Name — As entered on the Patient Details screen.
• Patient ID — As entered on the Patient Details screen.
• 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.
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Screen Footer Information
All programmer screens also display common information in the screen footer. (Figure 4-3):
Figure 4-2. Start Therapy Screen
Programmer cable status
Current date and time
Programmer battery status appears
here if capacity is low
Figure 4-3. Common Information in Screen Footer
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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. Status background color is white with pulsing border. Controller status light is partially lit
(see Figure 3-5). Communication buttons are disabled.
• Demo Mode — Wireless link between tablet and programmer cable is not active, but programmer may
be used for demonstration. Status background color is pink.
The programmer battery status displays one of the following messages in the bottom-center of all screens if
the battery is low or depleted.
• Battery Low — The programmer battery is nearing depletion and should be connected to power supply
• Recharge Battery — The programmer must be attached to the power supply to prevent an automatic
Programmer Battery Status
soon.
shutdown.
Current Date and Time
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.
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Start Screen
The buttons on the Start screen (Figure 4-4) are described in Table 4-1.
Figure 4-4. Start Screen
Button
Connect to
Generator
Test Connection
Table 4-1. Start Screen Button Descriptions
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.
• Evaluates communication strength before
connecting to the generator and is used to
determine best position for programmer cable and
head.
Note: Button is disabled until the tablet has
established a connection to the programmer cable.
Reports
• Accesses reports for previous programming
sessions.
• Reports can be reviewed and exported.
Settings
Demo
• Accesses the Programmer Settings screen.
• Allows access to data management controls and
adjustments to date and time, language, and
number format.
• Starts a practice programming session.
• Makes it possible to practice using the
programmer with a simulated generator when a
patient is not present.
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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
The Programmer Settings screen (Figure 4-5) allows the modification of general programmer settings, including:
Figure 4-5. Programmer Settings Screen
• Patient data management
• Date and time
• Language
• Number format
See “Adjusting Programmer Settings” on page 23 for more information.
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Home Screen
The Home screen (Figure 4-6) is divided into five sections:
Figure 4-6. Home Screen
• Therapy Status
• Workflows
• Setting Summary
• Patient Details
• Advanced Tools
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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.
• Usage — The number of hours Inspire therapy has been used since the last programming session. The
average usage per week also displays in parentheses.
• Battery — The generator battery has three status values: Good, Low, and Depleted. If the battery status
displays Low or Depleted, the physician should plan to replace the patient's generator.
• Last Session — The date of the most recent programming session.
Last session value
Patient selected value
Change flag
Figure 4-7. Patient Therapy Status
Workflows
This section provides access to guided clinical activities that may be performed during a session and displays the
status of those activities for the current session.
The workflow activities performed are determined by the clinician. The activities do not need to be performed in
any specific order, and the programmer has no requirements for how many activities are performed in a session.
Follow up
• Status Indicators:
• Button accesses the Follow Up screen which guides the user through adjusting settings to improve
comfort or efficacy. See “Follow Up” on page 70 for more information.
– Not Performed indicates activity has not been started (Figure 4-8).
– Started indicates the Follow up workflow has been started but not fully completed.
– Done with a check mark indicates activity has been completed.
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Sleep Study
• Status Indicators:
Initial Activation
• Status Indicators:
• 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.
– 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.
• Button accesses the Initial Activation workflow which guides the user through activities to be
performed when a patient’s therapy is first activated after implant. See “Initial Activation” on page 67
for more information.
– 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
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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.
(See Table 1-2 on page 4 and Table 1-3 on page 5 for an explanation of these terms.)
When settings change during a session, the values on the Home screen update and a blue setting value and check
mark indicates the setting has changed (Figure 4-9). Initial values from the start of the session are displayed in gray
and in parentheses.
Data from the current session can be viewed at any time by selecting the Current Report button which accesses
the Reports screen (see Figure 4-21).
Check mark indicates
change, and new value
displays in blue
Initial value displays in
parentheses
Figure 4-9. Status Indicators for Setting Summary
Patient Details
The physician’s name and implant date display in this section of the Home screen if that information has been
entered on the Patient Details screen.
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.
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System Check
• Status Indicators:
• Button accesses the System Check workflow which guides the user through troubleshooting activities.
See “Start System Check Workflow” on page 63 for more information.
– 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.
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Patient Details Screen
Access the Patient Details screen (Figure 4-10) from the Home screen.
Figure 4-10. Patient Details 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.
Note: The information entered on this screen is stored in the programmer, not the generator. If a different
programmer is used to communicate with the patient’s generator, this information will need to be entered
into that programmer as well.
Note: The ability to edit the Patient Name and Patient ID fields is controlled from the Programmer Settings
screen (Patient Information Storage).
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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.
• De-Identified ID — Enter the anonymous identifier. This will be the only patient information included
on de-identified reports.
• Physician Name — Enter the name of the physician responsible for the patient.
• Implant Date — Enter the date that the patient’s generator was implanted.
• Location — Enter the location of the generator in the body.
• Stim Lead Model Number — Enter the model number of the stimulation lead.
• Stim Lead Serial Number — Enter the serial number of the stimulation lead.
• Stim Lead Location — Enter the location of the stimulation lead electrodes in the body.
• 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.
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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. Adjust Stimulation Screen, Basic View
Basic Screen View
The basic screen view divides the settings into two sections: stimulation and timing.
Stimulation
• Use the arrow buttons to increase or decrease amplitude values.
• Select the Enable Patient Control box to allow (check) or disallow (uncheck) patients to adjust
amplitude within a predetermined range.
– Use the arrow buttons to set the upper and lower limits of this range.
– When Patient Control is enabled, changing the amplitude value will cause the upper and lower
limit values to change as well, tracking the amplitude value.
– The values displayed in parentheses next to the upper and lower limits indicate the relative value,
or difference, between the amplitude value and the limit value. 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.
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Use the arrow buttons to increase or decrease the following timing settings.
Timing
• 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. Confirm connection by
checking the programmer cable status in the screen footer (Figure 4-3).
• Select the Test Stimulation button to test the displayed settings, which may differ from those currently
configured in the generator. 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.
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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:
generator.
• 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)
• The Configure button is enabled when changes are made to the settings currently in use by the
• After selecting the Configure button, the highlighting is cleared because the displayed values now
match the newly configured generator settings.
• When therapy is turned on or setting changes are made with the therapy on, the generator needs
approximately 1–3 minutes to resynchronize with respiration. For this reason, it is recommended to
make changes only after observing therapy performance for 3–5 minutes.
Select a Preset
Use the Select a Preset button to change stimulation settings to one of the following:
• Initial Session Settings — Selects the generator stimulation settings from the start of the current
programming session.
• Current Generator Settings — Selects the stimulation settings currently in use by the generator.
Note: Selecting the Current Generator Settings preset clears all highlighting.
• 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.
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Advanced Screen View
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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.
• Select the Configure button to configure the generator with all displayed settings that differ from the
current generator settings.
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. Inspire System Electrodes
Icons are used on the Electrode button to indicate the polarity of all system electrodes. For example, the
default electrode is shown in Figure 4-15.
Outer electrode
Case electrode
Center electrode
Figure 4-15. Default Electrode Configuration
In this configuration, the three square lead electrode icons indicate that the outer electrode is positive and the
center electrode is negative. The round, filled-in case electrode indicates that the electrode is off and not used
in this configuration.
See Table 1-4 on page 7 for more information about these icons.
There are five electrode options to choose from, starting with A (default) and moving to E (least used). See
Table 4-3 on page 48.
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Table 4-3. Electrode Options
Default electrode
A
B
C
D
E
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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. Selecting the
Configure button will configure the generator with the highlighted values and clear the highlighting.
Exhalation (Red)
Inhalation (Blue)
Stimulation (Green)
Hard Off Period (Dark)
Figure 4-16. Adjust Sensing Screen, Basic View
Basic Screen View
Use the arrow buttons to increase or decrease the following sensing settings.
• Exhalation Sensitivity
• 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.
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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.
– When therapy is turned on or setting changes are made with the therapy on, the generator needs
approximately 1–3 minutes to resynchronize with respiration. For this reason, it is recommended
to make changes only after observing therapy performance for 3–5 minutes.
• The Stop Waveform button stops the waveform. If therapy was on when the waveform started, therapy
will remain on. If therapy was off when the waveform was started, therapy will turn off.
• Select the left and right arrow buttons to scroll through the waveform. Select the left and right arrow
buttons with a solid bar to jump to the beginning or end of the waveform.
Screenshot
Select this button to save an image of the displayed waveform in the session report and to
access the Screenshot screen (Figure 4-17).
• Choose one or more of the following optional labels to include with the waveform screenshot: sleep
type, position, and polarity.
• Select the Clear Selections button to remove label selections.
• 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.
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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:
generator.
• 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).
• The Configure button is enabled when changes are made to the settings currently in use by the
• After selecting the Configure button, the highlighting is cleared because the displayed values now
match the newly configured generator settings.
• 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.
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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).
Sense History
Select the Sense History button to access sensing settings stored in the programmer from earlier in the
session or from previous sessions.
Advanced Screen View
Figure 4-18. Adjust Sensing Screen, Advanced View
To modify advanced sensing settings, select the Advanced tab at the bottom of the screen (Figure 4-18).
• Use the arrow buttons to increase or decrease the following settings.
– Exhalation Threshold
– Soft Off Period
– Inhalation Sensitivity
– Inhalation Threshold
– Amplitude
– Max Stim Time
• 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.
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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.
• To reverse the order in which reports display, select the last session column header.
• To sort by another identifier, select a different column header.
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.
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To:
View patient
Table 4-4. Select a Patient Screen Buttons
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.
Delete a patient
Export patient reports to
external USB flash drive
Note: If arrow buttons are disabled, there are no
additional patients to view.
Highlight patient name and select Delete button to
display the Delete Reports screen (Figure 4-20).
• Specify a date using the arrow buttons to remove
all reports saved prior to that date.
• Select Delete button to confirm that you wish to
permanently remove all reports older than the
specified date for that patient.
Note: If a patient name is not highlighted before
selecting the Delete button, reports for all patients will
be deleted.
Attach the Inspire USB flash drive to the tablet.
• Highlight patient name and select the Export
button to display Export Report screen (Figure 4-
22). If Export button is disabled, go to Programmer
Settings screen to enable USB export.
• Specify a date using the arrow buttons to export all
reports since that date.
• Select the information to be included in the export
by checking one or more of the following boxes:
patient information, device information, waveform
screenshots, and advanced settings.
• Select Export button to complete export.
Note: If a patient name is not highlighted before
selecting the Export button, reports for all patients will
be exported.
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Reports Screen
Figure 4-20. Delete Report Screen
Figure 4-21. Reports Screen
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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.
Advanced settings display only if the initial or final value differs from the default value. Saved waveforms also
display.
From this screen, session reports for the current patient can be deleted or retained for records.
Refer to Table 4-5 for information about the functions of the buttons on the Reports screen.
Table 4-5. Reports Screen Buttons
To:
View selected report
View additional reports
Do This:
Select the date and time of the desired report in the left column of the screen.
Select the up or down arrow buttons below the list of reports in the left column
of the screen.
Note: If arrow buttons are disabled, there are no additional reports to view.
View additional sets of
recorded levels
Select the right or left arrow buttons above the levels information.
Note: If arrow buttons are disabled, there are no additional levels to view.
Select the Show Settings or Hide Settings button.
Show or hide settings for the
displayed waveform
View additional waveform
screenshots
Select the right or left arrow buttons above the waveform image.
Note: If arrow buttons are disabled, there are no additional screenshots to view.
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Delete a session report
Highlight report and select the Delete button to display the Delete Report screen
(Figure 4-20).
Table 4-5. Reports Screen Buttons
Export session report to
external USB flash drive
Attach the Inspire USB flash drive to the tablet.
• 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.
• Select Delete button to confirm that you wish to permanently remove the
selected report(s).
• Highlight report and select the Export button to display Export Report screen
(Figure 4-22). If Export button is disabled, go to Programmer Settings screen
to enable USB export.
• Select Export Selected Report button to export current report, or
• Select Export Combined Visit Report button to export a report that combines
programming sessions from the same visit, or
Note: The option to export combined reports will only be available if multiple
reports are detected within a +/-24-hour period.
• Select Export All Reports Since button and specify the date using the arrow
buttons to export multiple reports for the current patient.
• Select the information to be included in the export by checking one or more
of the following boxes: patient information, device information, waveform
screenshots, and advanced settings.
Note: Session reports will be exported as PDF (portable document format) files.
The programming log contains a CSV (comma separated value) file of all
generator setting changes for the session and a CSV file of the raw waveform
data.
• Select Cancel button to return to Reports screen.
• Select Export button to complete export.
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Figure 4-22. Export Report Screen
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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. Stimulation History Screen Buttons
To:
View more detailed information about
the sessions for a given date
Do This:
Select that date in the header row to review the relevant session
reports on the 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.
View additional sets of recorded
stimulation levels
Select the right or left arrow buttons in the levels section of the
screen.
Note: If arrow buttons are disabled, there are no additional levels
to view.
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Sensing History Screen
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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. Sensing History Screen Buttons
To:
View more detailed information about
the sessions for a given date
Do This:
Select that date in the header row to review the relevant session
reports on the 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.
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.
• System Check - Use this workflow to assess the integrity of the implanted system by checking
stimulation levels, observing waveforms, or measuring impedances. This is commonly done during
surgical implant or advanced troubleshooting.
• Initial Activation - Use this workflow when first turning on a patient’s therapy after the implant
procedure.
• Sleep Study - Use this workflow when the patient is undergoing an overnight sleep study.
• Follow Up - Use this workflow to make basic and advanced adjustments to the patient’s stimulation
settings. This can be done to improve patient comfort or therapy effectiveness.
The following sections contain additional detail on the activities performed during clinical programming sessions.
Generator Implant
Implant programming occurs during the surgical implant procedure. The programming goals of this session are to
verify stimulation function, sensor performance, and proper lead connections to the generator.
Implant Session Overview
• Start Session
• Enter Patient Details
• Check Generator Status
• Record Functional Level
• 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.
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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.
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.
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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. Check Workflow Screen
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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. If the electrode is correctly placed, the tongue
will move distinctly forward when stimulated at the functional level. If a tongue response cannot be
obtained at any amplitude, the stimulation lead may not be properly connected to the generator or nerve.
Note: If no tongue response is observed, alternate stimulation settings may be attempted. In addition, the
Impedances portion of the System Check Workflow may be utilized for troubleshooting.
4. Select the Save button next to the functional level to save the stimulation level.
Note: The sensation level is not recorded during implant.
5. Select Next Step.
Figure 5-3. System Check - Stimulation Levels Screen
Assess Sensor Performance
After the sensing lead is connected to the generator, complete the following steps to confirm sensor performance
and correct lead-generator connection:
1. On the Waveforms screen, change the amplitude to 1.5 V and select the Set Amplitude button.
2. Select the Start Waveform button to start the real-time waveform.
3. Review the waveform and verify that the waveform moves up or down with inhalation and exhalation. If
the waveform contains sharp high-frequency artifacts or a series of very short stimulation bursts, the
sensor lead may not be properly connected to the generator.
4. Select the Screenshot button to access the Screenshot screen and document the sensor performance.
a. 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.
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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. Select the Done button to complete the workflow.
Figure 5-5. System Check - Summary Screen
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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. End Implant Session - Home Screen
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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.
Start Initial Activation Workflow
From the Home screen select Start for the Initial Activation workflow.
Determine Stimulation Levels
Therapy must be turned off prior to starting the Initial Activation workflow.
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 patient can feel stimulation.
4. Select the Save button for the Sensation level to record the amplitude value.
5. Repeat steps 1 and 2 until a functional tongue motion is observed.
6. Select the Save button for the Functional level to record the amplitude value.
7. Select a description of the patient’s tongue motion at the Functional level.
8. Select the Next Step button.
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Figure 5-7. Initial Activation - Determine Stimulation Levels Screen
Observe Waveform
1.
2. Select the Start Waveform button and observe the waveform for 3 minutes.
It is recommended to start with the functional level. Select the Set Amplitude button.
3.
Note: This will turn on therapy and deliver stimulation based on the current generator settings.
If stimulation is uncomfortable for the patient, decrease the amplitude and select the Set Amplitude
button.
If necessary, repeat step 3 until a comfortable amplitude is achieved.
4.
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.
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Figure 5-8. Initial Activation - Observe Waveform Screen
Stimulation Summary
1. Review the Stimulation and Timing settings.
2.
3. Select the Configure button.
4. Select the Done button.
If desired, make any final changes.
Figure 5-9. Initial Activation - Stimulation Summary Screen
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End Session
Before ending the Initial Activation session:
1. Confirm that therapy is turned off.
2. Confirm the patient has the desired amplitude and control range.
3. Confirm that the Initial Activation Workflow has been completed.
4. 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.
Follow Up
The goal during Follow Up is to review and adjust stimulation settings to promote effective and comfortable use
of Inspire therapy.
Follow Up Overview
• Start Session
• Review Therapy Status
• Start Follow Up Workflow
• Basic Follow Up
• Advanced Follow Up
• End Session
• Retain Records
Start Session
Turn on the programmer and start a session by connecting to the generator.
Review Therapy Status
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.
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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 5-11. Follow Up Screen
Basic Follow Up
The following steps apply only to the Basic Follow Up.
1. Review the Stimulation and Timing settings.
Note: Pay attention to any Review flags that may appear.
2. Make desired changes using the arrows.
3.
4. Select the Done button.
If there are any new settings to program in the generator, select the Configure button.
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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. Repeat steps 2 and 3 until the patient experiences a tongue motion similar to current therapy.
5. Select the Save button for the Similar to Current Therapy level to record the amplitude value.
6. Select a description of the patient’s tongue motion at the Similar to Current Therapy level.
7.
If desired, repeat steps 2 and 3 until a functional tongue motion is observed. Select the Save button for
the Functional level and select a description of the patient’s tongue motion.
Note: Saving a Functional level is optional.
8. Select a different electrode option for evaluation.
Note: It is recommended to evaluate at least two electrode options.
Note: Selecting a different electrode option will clear the saved stimulation levels. These levels can be
viewed again if the previous electrode option is selected.
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.
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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. Advanced Follow Up - Select Electrode and Amplitude Screen
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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. Repeat steps 2 and 3 until the patient experiences a tongue motion similar to current therapy.
5. Select the Save button for the Similar to Current Therapy level to record the amplitude value.
6. Select a description of the patient’s tongue motion at the Similar to Current Therapy level.
7.
If desired, repeat steps 2 and 3 until a functional tongue motion is observed. Select the Save button for
the Functional level and select a description of the patient’s tongue motion.
Note: Saving a Functional level is optional.
8. Select a different pulse width/rate option for evaluation. These levels can be viewed again if the previous
pulse width/rate option is selected.
Note: It is recommended to evaluate at least two pulse width/rate options.
Note: Selecting a different pulse width/rate option will clear the saved stimulation levels.
9. Repeat steps 2-7 for the new pulse width/rate selection.
10. If desired, select additional pulse width/rate options for evaluation and repeat steps 2-7 for each
selection.
11. Select the Next Step button.
Figure 5-15. Advanced Follow Up - Evaluate Pulse Width and Rate Screen
Select Pulse Width/Rate and Amplitude
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.
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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
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.
Settings Summary
1. Review the recommended settings.
2.
3.
4. Select the Done button.
End Session
Before ending the Follow Up session:
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.
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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.
Sleep Study Overview
• Attach Programmer Head
• Place Programmer Cable in Night Mode (Optional)
• Start Session
• Review Therapy Status
• Start Sleep Study Workflow
• End Session
• Retain Records
Attach Programmer Head
After the sleep technician wires the patient for the PSG, complete the following steps to attach the programmer
head:
1. Route programmer cable over the patient’s shoulder.
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.
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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.
Start Session
Start a session by connecting to the generator.
Review Therapy Status
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.
Start Sleep Study Workflow
From the Home screen select Start for the Sleep Study Workflow.
Setup
1. Once the PSG recording has started, use the arrow buttons to select the test stimulation amplitude value.
It is recommended to start the sleep study 0.2 V below the incoming amplitude.
2. Select the Test Stimulation button to deliver one burst of stimulation at the selected amplitude. Confirm
that the stimulation is visible on the chin or submental EMG signal.
3. Determine inhalation and exhalation on PSG. During bio-calibrations, identify the direction of inhalation
on the PSG flow sensors.
Note: It is recommended to have both a nasal pressure canula and a nasal/oral thermistor to reliably
determine inhalation from exhalation during the sleep study.
4. Select Set Amplitude to program the amplitude.
Note: Amplitudes that are set are different from amplitudes that are configured. To set an amplitude is to
make a temporary change. 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.
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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. Monitor the patient’s response to therapy and if necessary, make adjustments throughout the study as
follows:
a. If persistent obstructive events occur, increase the amplitude and select Set Amplitude. Observe the
airflow response for at least 10 minutes and reevaluate the effectiveness of the amplitude setting.
b. If the programmed amplitude wakes the patient, turn therapy off, reduce the amplitude, select Set
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.
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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. Sleep Study - Stimulation Settings Summary Screen
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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.
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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. Select Export Combined Visit Report button to export a report that combines programming sessions from the
same visit.
Note: The option to export combined reports will only be available if multiple reports are detected within a
+/-24-hour period.
6. Select the information to be included in the export by checking one or more of the following boxes: patient
information, waveform screenshots, and advanced settings.
7. Select Export button to complete the export.
Note: Session reports will be exported as PDF (portable document format) files. The programming log contains a
CSV (comma separated value) file of all generator setting changes for the session and a CSV file of the raw
waveform data.
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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. When electrical interference is detected, the symbol below (Figure 6-1) is displayed on the
programmer head and on the tablet screen. When this error is encountered, remove any possible sources of
interference and reposition the programmer head over the generator.
Figure 6-1. Electrical Interference Symbol
Loss of Power to Programmer Cable
If power is disconnected from the programmer cable, reconnect to power. Normal operation resumes after power
is restored. Review generator settings by accessing the Home screen.
1. Make sure tablet is within range of the programmer cable.
2. Wait 60 seconds for the connection process to continue.
3. Tap the touchscreen. If this allows connection to proceed, continue tapping and restart the tablet at the
earliest convenience.
Programmer Cannot Find Generator
Refer to the steps described in "Testing Connection Strength" on page 25. If those measures do not resolve the
problem, the generator battery may be depleted. Try the following:
1. Use the patient’s remote to turn off the generator therapy. Try this several times if not immediately
successful.
If the patient’s remote is able to turn off the generator, retry communication using the programmer.
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.
If still unsuccessful, the generator may need to be replaced. Contact Inspire Medical Systems.
2.
3.
4.
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process.
illuminated.
8. Repeat steps 1–3.
9.
Systems.
Cannot Establish Connection to Programmer Cable
If the programmer cable status line in the screen footer always displays “searching for programmer cable”:
1. Navigate to the Start screen.
2. Ensure that the programmer cable is powered on.
3. Move tablet to within 1 m (3 ft) of the programmer cable.
4.
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.
5. Select the Shut Down button to power off the tablet and wait for the software to complete the shutdown
6. Disconnect the programmer cable.
7. Reconnect the programmer cable and press and hold the tablet power button until the power light is
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
Tablet
Tablet Will Not Power On
If the tablet will not power on, the battery may be fully discharged.
1. Connect the tablet to an electrical outlet.
2. Press and hold the power button on the side of the tablet until the power light is illuminated.
If this does not resolve the problem, contact Inspire Medical Systems.
Tablet is Slow to Respond or Freezes
If the programmer is not responsive to touchscreen input for more than 2 minutes:
1. Press and hold the power button until the tablet shuts off.
2. Disconnect and reconnect the programmer cable from power.
3. Power on the tablet and proceed from where you left off.
Note: Never let a patient leave after a forced programmer shut-off until you reconnect to the generator
and confirm the generator settings.
If the tablet is slow or appears to freeze during connection (progress bar stops for 30 seconds on the
communication screen, the light on the programmer head is not flashing, and you have waited for 30 seconds),
take these steps:
Storage Full Notification
A storage full notification displays when the tablet’s memory has reached full capacity. Session reports must be
deleted to free up space.
1. Select the Reports button from the Start screen.
2.
3. Select the Shut Down button on the Start screen and restart the programmer before the next
Identify reports that may be deleted.
programming session, otherwise the next session report will not be stored.
Battery Life
If the length of the battery life is poor (e.g., lasts for less than 45 minutes) even when the battery is fully charged,
contact Inspire Medical Systems.
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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). Disconnect and reconnect power to the programmer cable, and if the error is not resolved, contact
Inspire Medical Systems.
Figure 6-2. Error Mode Indicator
Settings
Daylight Savings Time
The programmer does not automatically adjust for daylight savings time. Use the Programmer Settings screen to
manually update the date and time when local time changes occur.
Wrong Language or Number Format
If programmer screens do not display your native language:
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.
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Start Screen
Programmer Settings 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. Push the Configure button. If you leave a screen before pushing this button, the changes will not be saved
to the generator.
3. Review settings on the Home screen before ending the session.
4. Always allow all communications to complete before a patient leaves. If a patient is allowed to leave during
a test stimulation or impedance measurement, the generator may not be restored to therapy settings.
Usage
The therapy usage status displays red on the Home screen when therapy has been on for less than 4 hours per
night since the last programming session. Reference the last session date on the Home screen.
Therapy Is On But Stimulation Is Not Active
If you have selected the Therapy On button but therapy appears to be inactive, the generator may be in start delay
or pause time.
Patient Amplitude Change Is Incorrect
If the previous programming session was not ended properly or was conducted with an earlier version of the
programmer software, the patient amplitude change information that displays on the Home screen may be
incorrect.
To ensure that patient amplitude change information is correct follow these guidelines:
• Always review therapy settings and properly end the programming session before the patient leaves.
(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.
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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. This screen is used
to assess the integrity of leads, lead electrodes, and the lead-generator connection.
Figure 6-4. Measure Impedances Screen
Follow the numbered steps on screen to measure impedances:
1. Review Amplitude.
• Use the arrow buttons to increase or decrease amplitude.
• The default amplitude setting is 1.5 V. Higher amplitudes increase measurement accuracy, but may be
uncomfortable for the patient.
2. Select the Measure Impedances button.
comfortable.
3. Analyze impedance measurement results.
• It is recommended to measure impedances at 1.5, 2.0, 2.5, 3.0, and 3.5 V while the patient remains
• 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.
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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.
If the waveform is orange, the generataor is in start delay or pause time, or the programming head is out of
connection range.
1. Select the Turn Off therapy button on the Adjust Sensing screen.
2. Select the Start Waveform button to restart therapy in waveform mode.
3.
If that does not resolve the problem, the programmer head may not be properly positioned. Reposition
the programmer head directly over the generator.
Note: The programmer head may shift when the patient changes sleep positions. Assess connection
performance in all sleep positions.
Reports
Report Data Display as “---”
When data such as levels or peak pressure display as “---”, it means that a value was not collected during the
programming session.
If settings such as amplitude display as “---”, the report may be corrupted. The data may be available in a previous
or later report.
Reports Do Not Contain Patient Information
Review the data controls on the Programmer Settings screen. Select the check box for Enable Patient Information
Storage.
Cannot Find a Report
If you cannot locate a particular report and the generator underwent a reset, then the report may be stored under
the serial number 000001 or 300000.
If you cannot locate a particular report and a generator reset did not occur, the programmer may have run out of
storage space. See "Storage Full Notification" on page 84 for more information.
Abnormal Impedances
Impedance measurement results less than 200 ohms may indicate a lead–generator connection problem. Test
stimulation to confirm a good lead–generator connection.
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.
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Programmer Model 2740
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.
b.
If the patient information displayed is correct, select the Configure button to configure the generator
with the entered serial number.
If the patient information is incorrect, enter the correct serial number and select the Check button.
Confirm that patient information is correct and select the Configure button.
Note: The generator will reset to default parameters.
3.
If the serial number is unavailable, select the Cancel button. When prompted, select the generator model
and select the Configure button. The generator will be configured with a temporary serial number and the
session report will be stored under the temporary serial number without a patient name or ID.
Exporting
Cannot Export Report
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.
4.
If these measures do not resolve the problem, use a different USB drive with FAT32 formatting.
Missing Information
If an exported report is missing patient information, screenshots, or advanced settings such as electrode
configuration or level measurement settings, select the check box that corresponds to the desired information on
the Export Report screen and repeat the export.
Note: The option to include patient information, screenshots, and advanced settings in an exported report always
displays regardless of whether the content is available for a particular report. Review the report on screen to
determine if the content is available.
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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. Depending on generator battery settings and usage, the generator may last for days or
weeks after the battery status displays Low.
• Only charge the battery when its temperature is between 0°C and 40°C.
• Use only the tablet power supply provided with the tablet. Do not use the tablet power supply to power
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective
any other electronic devices.
earth.
• The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use
is necessary, the programmer and other equipment should be observed to verify normal operation.
Precautions
Defibrillation
When a patient is in ventricular or atrial fibrillation, the first consideration is patient survival. Use of external
defibrillation or cardioversion while the programmer head is in contact with the patient may induce currents into
the device that may damage the device. It is recommended to remove the programmer head from the patient prior
to the use of defibrillation.
Setup
• When moving the system between environments with very different humidity and/or temperature
ranges, allow sufficient time to adjust to the new humidity or temperature.
• Do not drop the system components or subject them to other mechanical shocks.
• Do not apply heavy pressure to the system components or subject them to strong impact. Excessive
pressure or impact can cause damage to tablet components or otherwise cause malfunctions.
• Do not place the system components in an unsteady location. If the tablet is placed in an unsteady
location, such as on an unstable stand or incline, the tablet may fall or tip over and cause injury.
• 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.
• When using the tablet for long periods of time, rest your eyes for approximately 10–15 minutes every
hour. Failing to rest your eyes can cause eye strain and other deterioration of eye health.
• The programmer can be susceptible to electromagnetic interference and must be used according to the
electromagnetic compatibility (EMC) guidelines found in this manual.
Operating Environment
• To avoid possible electric shock, do not allow the patient to touch the programmer or use the
programmer in the patient environment (within 1.5 meters/5 feet).
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• 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. To
avoid damaging the display, clean it frequently by diluting a household, water-based glass cleaner to a
50/50 ratio with water, and spray a small amount on a clean, soft cloth and gently wipe the screen.
Always shut down and unplug the programmer before cleaning. Do not spray cleaner directly on the
tablet.
• Electromagnetic disturbances from the programmer may interfere with other equipment or the
programmer could be interfered with by other equipment, including portable and mobile Radio
Frequency (RF) communications equipment. If interference occurs, relocate the equipment.
• Do not bring the programmer into Zone 4 (magnet room), as defined by the American College of
Radiology. The programmer is MR Unsafe.
• Electromagnetic interference could be caused by unseen sources such as radio frequency identification
(RFID) devices or wireless charging (Qi). If interference is suspected, relocate the equipment and use
the Test Connection feature to evaluate connection performance.
• 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. Tablet operation system (Microsoft
Windows) is protected using write filtering, therefore, anti-virus software is not required nor
supported. Return system components to Inspire Medical Systems for secure decommissioning. Notify
Inspire Medical Systems of any suspected security event.
• Do not dispose of the system components if they are no longer being used or if they become
inoperable. They must be returned to Inspire Medical Systems.
• Dispose of the tablet (containing a lithium-ion battery pack) only at approved disposal sites. To locate
an appropriate site, contact the solid waste disposal officials where you live, or look for a rechargeable
battery recycling Web site that lists disposal locations.
• Do not dispose of tablets (containing a lithium-ion battery pack) in a fire. They may explode. Dispose
of used batteries according to the manufacturer’s instructions. The label on the battery lists the
manufacturer’s name.
Disposal
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Programmer Model 2740
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). The
device has not been tested for safety or electromagnetic emissions in this configuration, and proper
performance cannot be guaranteed. Plug the power cord directly into an electrical outlet.
• When using the power cord, make sure to position it around objects so it will not be cut or punctured.
• Make sure the connection where the power cord connects to the mains power is easily accessible and
can be easily disconnected by the user.
Tablet Battery Pack
the battery pack.
• The tablet contains an internal lithium-ion (Li-ion) battery pack. Do not attempt to remove or replace
• Always store the programmer with the battery charged and attached to the tablet.
• If the programmer is stored for more than 4 weeks without use, connect it to power until it is fully
charged. The tablet does not need to be turned on to charge.
• 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.
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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.
• Keep liquid, including the cleaning fluid, out of any openings.
• Test cleaning products on a small portion of the programmer before use.
• Do not spray cleaner directly on the tablet.
• Clean the exterior case of the programmer with a soft cloth lightly dampened with water.
• To clean the LCD screen, dilute a household, water-based glass cleaner to a 50/50 ratio with water and
spray a small amount on a clean, soft cloth and gently wipe the screen.
• Periodically disinfect the tablet, stylus, and programmer cable according to your institutional polices for
surface and equipment safety and cleanliness.
Storing the Programmer
Always store the programmer with the battery fully charged.
If the programmer is stored for more than 4 weeks without use, connect it to power until the battery is fully
charged. The tablet does not need to be turned on to charge.
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.
Please write the programmer serial number on all correspondence. The programmer serial number is located on
the programmer head and on the back of the tablet.
Contact Inspire Medical Systems for replacement parts.
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Default Settings
Table 8-1 lists the default values for all basic and advanced settings.
Table 8-1. Default Setting Values
Setting
Value
Amplitude
0.0 V
Electrode configuration
Configuration A
Exhalation sensitivity
Exhalation threshold
Hard off period
Inhalation sensitivity
Inhalation threshold
Invert signal
Maximum stimulation time
Patient control
Pause time
Pulse width
Rate
Soft off period
Start delay
Therapy duration
-4
-1
38%
0
+1
Off
4 s
Off
15 m
90 μs
33 Hz
13%
30 m
8 h
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Programmer Model 2740
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).
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.
Tablet
Table 8-2. Tablet Specificationsa
Description
Specifications
Temperature with power on
Temperature with power off for
storage or transportation
Tablet power supply Sinpro
M/N: HPU3*-105
(UL agency approval under
UL 60601-1)
Temperature: 5°C–30°C (41°F–86°F)
Humidity: 20–80%
Air pressure: 700–1013 hPa (10.2–14.7 psi)
Temperature: -20°C–60°C (-4°F–140°F)
Humidity: RH 10–90% RH
Air pressure: 700–1013 hPa (10.2–14.7 psi)
Input: 100–240 VAC, 47–63 Hz, 0.6-0.4A.
Output: 12V, 2.5A.
Ingress protection
IP65
Mode of operation
(continuous or non-continuous)
a All measurements are approximate
Continuous
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Programmer Cable
Description
Temperature with power on
Table 8-3. Programmer Cable for Model 2740a
Specifications
Temperature: 5°C–37°C (41°F–99°F)
Humidity: 20–80%
Air pressure: 697–1060 hPa (10–15.4 psi)
Temperature: -20°C–60°C (-4°F–140°F)
Humidity: RH 10–90% RH
Air pressure: 187–1060 hPa (2.7–15.4 psi)
Input: 100–240 VAC, 50-60 Hz, 6 A
Output: 12 VDC, 1.5A, 18W
175 kHz Short-range inductive link
2.4 GHz ISM band
IP22
Continuous
Temperature with power off for storage or
transportation
Programmer cable power supply (Class I)
Globtek P/N: TR9CE1500CCP-IMR6B
(Type BF applied part, Class I system)
(UL agency approval under
UL 60601-1)
Telemetry
Bluetooth
Ingress protection
Mode of operation (continuous or
non-continuous)
a All measurements are approximate
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Programmer Model 2740
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. Your
organization's particular needs and security requirements may call for additional actions and controls. Each
organization must reach its own decisions on how to implement appropriate safeguards.
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. Also, the option not to allow
the export of PHI is available on the Programmer Settings screen. Disable (uncheck) the Patient Information Export
feature if you do not PHI to be exported. In general, we recommend treating the programmer as if it contains PHI.
It is also recommended that reports retained from the device be treated in the same manner as any other medical
record, particularly if any patient identifier (such as a patient name or record label) has been included in the report.
Essential Performance
Essential performance of the Model 2740 Inspire programmer has been determined to be uninterrupted
performance or recovery from performance interruption with or without a restart of the programmer.
FCC Notice (USA)
Electromagnetic disturbances can potentially disrupt, degrade, or otherwise interfere with authorized electronic
emissions, which may include television, AM/FM broadcasts, cellular services, radar, air traffic control, and pagers.
The Federal Communications Commission (FCC) Rules and Regulations have established Radio Frequency (RF)
emission limits to provide an interference-free RF spectrum. Many electronic devices, including computers,
generate RF energy incidental to their intended function and are, therefore, covered by these rules.
The Inspire Programmer (Model 2740) tablet, programmer cable, and all accessories meet the U.S. and European
regulatory limits for Electromagnetic Compatibility (EMC). EMC is the ability of electronic devices, including
computers, to function properly together in the electronic environment. However, there is no guarantee that in a
specific installation it will not cause interference. Should this equipment cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, you are encouraged to try to
correct the interference by one or more of the following measures:
• Reorient the receiving antenna.
• Relocate the programmer.
• Separate the equipment and the programmer.
• Plug the equipment and the programmer into different electrical outlet circuits.
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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.
Embedded in the programmer are various Radio Frequency (RF) wireless communication devices. It may contain
one or more radio-type devices that operate in the 450–1550 KHz band, 13.56 MHz, as well as devices that operate
in the 2.4 or 5.4 GHz band. All radio-type devices embedded in your tablet have met all the qualifications for use
under FCC regulations and guidelines.
This equipment complies with FCC Radio Frequency Electromagnetic Signal (RF) exposure limits set forth for an
uncontrolled environment of portable transmission. This product has been evaluated for RF exposure at a distance
of 20 cm (8 inches). Operation at a separation distance less than 20 cm (8 inches) from the radiating element to
nearby persons will not expose nearby persons to RF levels that exceed the FCC rules for RF exposure.
Warning: Do not attempt to service the wireless communication devices built into the programmer yourself. Such
action may void the warranty on the tablet. Contact Inspire Medical Systems for information about servicing your
wireless communication device.
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.
FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits for radio frequency devices used in an uncontrolled
environment. To satisfy the grant limitations of co-location and simultaneous operation, the device should not be
operated within 20 cm of any other antenna or transmitter.
This equipment contains an internal antenna transmitter whose effective use may be affected if it is co-located or
operating in conjunction with any other antenna or transmitter.
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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.
Additional non-standardized testing was performed to demonstrate that the Bluetooth wireless communications
of the programmer can coexist with potential interfering devices like a Wi-Fi router. With the source of
interference located 1 meter (3 feet) from the programmer tablet or programmer cable, the programmer’s
Bluetooth suffered no decrease in performance.
Table 8-4. Electromagnetic Emissions
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.
Emissions Test
Compliance
Electromagnetic Environment Guidance
Radio frequency
(RF) emissions
CISPR 11
Group 1
RF emissions CISPR
11
Class A
Class A
Complies
Harmonic
emissions
EN 61000-3-2
Voltage
fluctuations/flicker
emissions EN
61000-3-3
The programmer uses RF energy for its internal
function. Therefore, its RF emissions are very
low and are not likely to cause any interference
in nearby electronic equipment.
The programmer is suitable for use in
professional healthcare facility environments.
Note: The emissions characteristics of this
equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR 11
class B is normally required) this equipment
might not offer adequate protection to radio
frequency communication services. The user
might need to take mitigation measures, such as
relocating or re-orienting the equipment.
Warning: This system is intended for use by
health care professionals only.
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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
Compliance Level
Electromagnetic Environment Guidance
Electrostatic
discharge (ESD):
EN/IEC
61000-4-2
Electrical fast
transient/burst:
EN/IEC 61000-4-4
Surge: EN/IEC 61000-
4-5
EN/IEC 60601 Test
Level
+/-8 kV contact
+/-8 kV contact
+/-15 kV air
+/-15 kV air
±2 kV for power
supply lines
±1 kV for input/
output lines
+/-2kV for input AC
power port
+/-1 kV for
signal I/O port
100 kHz repetition
frequency
+/-0.5 kV, +/-1
kV line-to-line
+/-0.5 kV, +/-1
kV, +/-2 kV
line-to-ground
±2 kV for power
supply lines
(no input/output
lines)
+/-2kV for input AC
power port
+/-1 kV for
signal I/O port
100 kHz repetition
frequency
+/-0.5 kV, +/-1kV
line-to-line
+/-0.5 kV, +/-1kV,
+/-2 kV
line-to-ground
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrostatic discharge may result in a
temporary loss of function, requiring the
user to restart the programmer.
Mains power quality should be that of a
typical commercial or hospital
environment.
Electrical fast transients or bursts in mains
power may result in temporary loss of
function.
Mains power quality should be that of a
typical commercial or hospital
environment.
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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
Compliance Level
Electromagnetic Environment Guidance
Voltage dips, short
interruptions and
voltage variations on
power supply
input lines:
EN/IEC
61000-4-11
EN/IEC 60601 Test
Level
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
Voltage Dips
0% UT; 0.5
cycle at 0, 45, 90,
135, 180, 225, 270,
and 315°
0% UT; 1 cycle and
70% UT;
25/30 cycles Single
phase: at 0°
Voltage
Interruptions
0% UT; 250/300
cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT) for
25 cycles
Voltage Dips
0% UT; 0.5
cycle at 0, 45, 90,
135, 180, 225, 270,
and 315°
0% UT; 1 cycle and
70% UT;
25/30 cycles Single
phase: at 0°
Voltage
Interruptions
0% UT; 250/300
cycle
Note: UT is the A.C. mains voltage prior to application of the test level.
Mains power quality should be that of a
typical commercial or hospital
environment. The tablet contains an
integrated battery that must be charged
for use without mains power. The
programmer cable requires uninterrupted
mains power to operate.
Interruptions in mains power may result in
temporary loss of function.
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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.
Immunity Test
EN/IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Portable and mobile RF communications
equipment should be used no closer to any
part of the programmer, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
6 Vrms in ISM
bands between
0.15 MHz and
80 MHz
80% AM at
1 kHz
6 Vrms in ISM
bands between
0.15 MHz and
80 MHz
80% AM at
1 kHz
3 V/m
80 MHz - 2.7
GHz
80% AM at
1 kHz
3 V/m
80 MHz - 2.7
GHz
80% AM at
1 kHz
30 A/m
30 A/m
Conducted RF
EN/IEC 61000-
4-6
Radiated RF EN/
IEC
61000-4-3
Power
frequency
magnetic field:
EN/IEC 610000-
4-8
d
=
1.2 P
d
=
1.2 P
80 MHz to 800 MHz
d
=
2.3 P
800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.
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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.
Immunity Test
EN/IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment
Guidance
Interference may occur in the vicinity of
equipment marked with the following symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the programmer is used exceeds the applicable RF compliance level above, the programmer should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the programmer
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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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
help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the programmer as recommended
below, according to the maximum output power of the communications equipment.
Rated
maximum
output power
of transmitter
W
0.01
0.1
1
10
100
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
d
=
1.2 P
d
=
1.2 P
d
=
2.3 P
0.12
0.38
1.2
3.8
12
0.12
0.38
1.2
3.8
12
0.23
0.73
2.3
7.3
23
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency
range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
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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. Unused Tablet Features, Front
Item
Function
Function button
None
WiFi Light
Indicates WiFi connection
(unused)
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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
SD port
Figure 8-2. Unused Tablet Features, Right Side
Table 8-9. Unused Tablet Features, Right Side
Function
Item
HDMI port
SIM port
SD port
None
None
None
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Programmer Model 2740
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
Function
Audio port
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. Unused Tablet Features, Back
Item
Function
Camera
Speaker
None
None
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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.
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Programmer Model 2740
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. The information below takes
precedence over the information contained in this Summary.
Inspire Medical Systems' products consist of generators, tools to connect the generator to implantable leads, leads,
Inspire Sleep Remotes, and physician programmers.
1. EXCLUSION OF WARRANTIES, NO WARRANTIES FOR TOOLS. The implied warranties of
MERCHANTABILITY and fitness for a particular purpose and all other warranties, express or implied with
regard to tools are EXCLUDED from any transaction and shall not apply. Inspire Medical Systems will not
be liable for any damages, whether direct, consequential, or incidental caused by tool defects, failures, or
malfunctions, whether such claims are based on warranty, contract, tort or otherwise. No person has any
authority to bind Inspire Medical Systems to any representation or warranty with respect to tools. You may
have other rights, which vary from state to state. If one or more of the provisions of this exclusion of
warranties for tools shall be deemed void or unenforceable, the remaining provisions shall continue to
have full force and effect.
LIMITED WARRANTY FOR PRODUCTS OTHER THAN TOOLS. This limited warranty is available if products
other than tools fail to function within normal tolerances due to defects in materials or workmanship that
manifest during the specified warranty period.
2.
During the operational life of an generator, battery energy is consumed to monitor the patient's breathing and
provide therapy. On the basis of individual patient physiology, certain patients may require more frequent therapy,
thus requiring replacement of the generator in less than the warranty period shown below. This is considered
normal for those patients and not a malfunction or defect in the generator.
If the purchaser complies with the Terms and Conditions, Inspire Medical Systems will issue a limited warranty
toward the purchase of a new Inspire Medical Systems generator product. The limited warranty credit amount will
be the full purchase price of either the original unit or the replacement unit, whichever is less.
Programmer Model 2740
English 111
• 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.
• For physician products, for example, physician programmer, Inspire Medical Systems will issue a credit
to the original purchaser of the product.
A.
Terms and Conditions
1. The product labeling must indicate a limited warranty exists.
2. For implantable products, this limited warranty applies only for a product replacement in the original
3. All registration materials must be completed and returned to Inspire Medical Systems within 30 days of
patient.
first use.
4. The product must be replaced with an Inspire Medical Systems product.
5.
If the product is implantable, it must be implanted before the product expires and implanted with other
Inspire Medical Systems products.
6. The product must be returned to Inspire Medical Systems, 5500 Wayzata Blvd., Suite 1600, Golden Valley,
MN 55416 within 30 days that the product first fails to function within normal tolerances. The product
may be returned at no cost to you. Contact your Inspire Medical Systems representative for information
on how to return the product.
Inspire Medical Systems will inspect the returned product and determine whether a limited warranty
credit is due.
7.
8. All products returned to Inspire Medical Systems become its property.
This limited warranty represents the entire obligation of Inspire Medical Systems for products other than tools and
is made IN LIEU OF any other warranties, whether express or implied, including MERCHANTABILITY or fitness for
a particular purpose.
Inspire Medical Systems will not be liable for any damages, whether direct, consequential, or incidental caused by
product defects, failures, or malfunctions, whether such claims are based on warranty, contract, tort or otherwise.
No person has any authority to bind Inspire Medical Systems to any warranty or representation except those
specifically contained herein.
This limited warranty gives specific legal rights, and you may also have other rights, which vary from state to state.
If one or more of the provisions of this limited warranty shall be deemed void or unenforceable, the remaining
provisions shall continue to have full force and effect.
B.
Limited Warranty Period
The applicable limited warranty period for each product is listed and calculated as follows:
• Within the United States:
• Outside the United States:
1 Three (3) years from date a generator or lead is implanted in the patient.
2 One (1) year from the date a physician programmer or Inspire Sleep Remote is first used.
1 Three (3) years from date a generator or lead is implanted in the patient.
2 Two (2) years from the date a physician programmer or Inspire Sleep Remote is first used.
112 English
Programmer Model 2740
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
1 | Internal Photos | Internal Photos | 1.51 MiB | February 09 2021 / August 08 2021 | delayed release |
1 | External Photos | External Photos | 2.32 MiB | February 09 2021 / August 08 2021 | delayed release |
1 | ID Label | ID Label/Location Info | 304.84 KiB | February 09 2021 / February 10 2021 |
D C B A 8 7 6 5 4 3 2 1 1.439 REV DESCRIPTION A INITIAL PRODUCTION RELEASE B UPDATE FCC LABEL CONTENT ECO NUMBER DATE DRFT APRV 20-00675 21-00755 7/17/2020 1/15/2021 TY TY KV AR REVISION
.015 SELECTIVE REAR ADHESIVE NOTES:
CTQ-1 UV MATTE TOP PRINT, ALL EXCEPT WINDOW WINDOW PRINT TO CUT TOLERANCE
+/-.010 GRAPHITE
(UN7994, RGB:
38,45,51) WHITE 3.308.015 CTQ-2 1. MATERIAL: 10 MIL MARNOT XL HARDCOATED CLEAR GLOSS PC WITH 3M 7952MP REAR ADHESIVE (2 MIL). MATERIAL CERTIFICATION TO BE PROVIDED WITH EACH LOT. 2. SEE ART FILES FOR COMPLETE GEOMETRY DEFINITION. P/N'S 200-334-001 & 200-334-002 HAVE THE SAME GEOMETRY WITH DIFFERENT ART AND SHARE THIS DRAWING (200-334-002 SHOWN). 3. CTQ ARE CRITICAL INSPECTION DIMENSIONS (2). 4. UNLESS OTHERWISE SPECIFIED GENERAL TOLERANCES APPLY: CUT-TO-CUT & PRINT-TO-
CUT
.020, PRINT TO PRINT
.010. 5. THE PARTS SHALL BE PACKAGED IN A MANNER THAT PREVENTS DAMAGE OR CONTAMINATION FROM FOREIGN MATERIAL. EACH MANUFACTURING LOT SHALL BE LABELED IN ACCORDANCE WITH INSPIRE SPEC 700-006-000. 6. UPON APPROVAL BY INSPIRE MEDICAL SYSTEMS OF THE INITIAL DESIGN, ANY PROCESS CHANGES, DESIGN CHANGES, PACKAGING CHANGES, RAW MATERIAL CHANGES, OR DEVIATIONS CONSIDERED BY THE MANUFACTURER MUST BE SUBMITTED TO INSPIRE IN WRITNG FOR PRE-APPROVAL. THE INFORMATION SUBMITTED SHALL INCLUDE A COMPLETE DESCRIPTION OF THE CHANGE AND THE EFFECT THE CHANGE WILL HAVE ON ALL THE CHARACTERISTICS OF THE DEVICE/MATERIAL. UPON REQUEST, THE MANUFACTURER SHALL SUBMIT SAMPLES OF THE PROPOSED DEVICE/MATERIAL FOR EVALUATION AND APPROVAL BY INSPIRE MEDICAL SYSTEMS. D C B A IMS P/N REV 200-334-001 200-334-002 B B DESCRIPTION BACK LABEL, PROGRAMMER CABLE, US BACK LABEL, PROGRAMMER CABLE, GLOBAL
.012 8 7 6 5 4 3 PROPERTY AND CONFIDENTIAL The information contained in this drawing is the sole property of Inspire. Any reproduction in part or as a whole without the express written permission of Inspire is strictly prohibited. 1
.01 X.X X.XX X.XXX ANGLES
.005 2.0 Inspire Medical Systems, Inc. Golden Valley, MN USA TITLE: BACK LABEL, PROGRAMMER CABLE DOCUMENT CREATED BY:
DATE 11/25/2019 APPROVED A. RASMUSSEN DATE 11/25/2019 All dimensions in inches unless otherwise noted 200-334-000 REV. SHEET B 1 OF 1 1 T. YOCH DWG NO. SIZE B 2
1 | Agent Authorization Letter | Cover Letter(s) | 27.69 KiB | February 09 2021 / February 10 2021 |
& Inspire Agent Authorization Letter Sleep Apnea Innovation Inspire Medical Systems, Inc. 5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416 844-OSA-HELP | InspireSleep.com 07 January 2021 o whom it may concern, le, the undersigned, hereby authorize Joel Aaberg to act on our behalf, as our agent, in the following matters related to the FCC and/or Industry Canada approval of our products: report submittal, related correspondence, the signing of all documents relating to these matters, and any other lawful activity necessary to obtain such certification. Any act carried out by Joel Aaberg within the scope of this authorization shall have the same affect as our own. Dave Dieken rogram Director, Product Development
1 | Antenna Info | Operational Description | 75.48 KiB | February 09 2021 / February 10 2021 |
Antenna Info List of Antennas:
Coil loop antenna located in programmer head Manufacturer: Inspire Medical Systems, Inc. Frequency: 175.8 kHz Number of Turns: 36 (see attached drawing) Description: Loop antenna Drawing or Photograph See Telemetry Head Measurements.pdf. FCC 15.203 Compliance This antenna is permanently attached, thus complying with 15.203. Two ceramic loop antennae located in the programmer cable controller Gain: Peak 2.5 dBi Description: Loop Antenna Drawing or Photograph See Antenna 1+2 Datasheet.pdf. FCC 15.203 Compliance These antennae are permanently attached, thus complying with 15.203. Inspire Medical Systems, Inc. 5500 Wayzata Blvd., Suite 1600, Golden Valley, MN 55416 844-OSA-HELP | InspireSleep.com
1 | Cover Letter | Cover Letter(s) | 36.98 KiB | February 09 2021 / February 10 2021 |
In pire Inspire Medical Systems, Inc. 5500 Wayzata Blivd., Suite 1600, Golden Valley, MN 55416 844-OSA-HELP | InspireSleep.com Date (26 January 2021) Sleep Apnea Innovatio Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: FCC Application FCC ID: 2AGO22740PGC To whom it may concern, We, Inspire Medical Systems Inc., hereby apply for original certification of the Programmer Cable radios included in the Model 2740 Physician Programmer system. The programmer head intentional radiator operates at 175kHz and is compliant to 47 CFR 15.209. The Wi-Fi and Bluetooth radios operate at 2.4GHz. Each of these radios are compliant to 47 CFR 15.247. Sincerely, elas la Oe Aaberg elephone Number: 763-205-7972 Email:
1 | Request for Confidentiality | Cover Letter(s) | 65.75 KiB | February 09 2021 / February 10 2021 |
ln pi of Regulatory Sleep Apnea Innovation Ss re 25 January 2021 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2AGO22740PGC a Kee re) r mia tie ee lie 0a F Pursuant to Sections 0.457(d) and 0.459 of the Commissions Rules, Inspire Medical Systems, Inc. hereby requests long-term confidential treatment of information accompanying this application as outlined el) [e) Block Diagram Operational Description Schematics Internal Photos (Telemetry Head)*
*Confidentiality of Internal Photos Pursuant to Sections 0.457(d) and 0.459 of the Commission's Rules, internal photos may be eligible for long-term confidentiality in the following circumstance:
e May be held confidential if the circuit board or internal components are not accessible to users. For example, it is acceptable if the circuit board is enclosed in epoxy. The telemetry head of the device (the subject of the filing) is encased in overmolded Thermoplastic elastomer (TPE) and prevents user access to internal components. Accordingly, Inspire Medical Systems, Inc. requests that the internal photos pertaining to the telemetry head be withheld from public disclosure following grant of the application. Inspire Medical Systems, Inc. also hereby requests short-term confidential treatment of information accompanying this application as outlined below for a period of 180 days:
ee =)amut-la let) e External Photos e Test Set-up Photographs e Internal Photos (Programmer Controller) The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the Applicant and provide unjustified benefits to its competitors. The Applicant understands that pursuant to Rule 0.457(d)(1)(ii), disclosure of this Application and all accompanying materials will not be made before the date of the Grant for this Application. You sincerely, Name: Joel Aaberg itle: Senior Director Inspire Medical Systems Inc 5500 Wayzata Blivd., Suite 1600, Golden Valley MN 55416 844-OSA-HELP | InspireSleep.com
1 | Test Setup Photos | Test Setup Photos | 1.18 MiB | February 10 2021 / August 08 2021 | delayed release |
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2021-02-10 | 2412 ~ 2462 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2021-02-10
|
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1 | Applicant's complete, legal business name |
Inspire Medical Systems, Inc.
|
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1 | FCC Registration Number (FRN) |
0025086356
|
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1 | Physical Address |
5500 Wayzata Blvd Suite 1600
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1 |
5500 Wayzata Blvd
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1 |
Golden Valley, MN
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1 |
United States
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app s | TCB Information | |||||
1 | TCB Application Email Address |
r******@element.com
|
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1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
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app s | FCC ID | |||||
1 | Grantee Code |
2AGO2
|
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1 | Equipment Product Code |
2740PGC
|
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app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D******** D********
|
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1 | Title |
Program Director
|
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1 | Telephone Number |
763-2********
|
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1 | Fax Number |
763-5********
|
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1 |
d******@inspiresleep.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/08/2021 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | 2740 | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Output power is conducted. This device supports 802.11b and 802.11g with a 20 MHz bandwidth and 802.11n with 20 MHz and 40 MHz bandwidth modes. This device also supports Bluetooth Low Energy. The antenna(s) used for this transmitter must not be collocated or operating in conjunction with any other antenna or transmitter within a host device, except in accordance with FCC multi-transmitter product procedures | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Element Materials Technology Minneapolis
|
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1 | Name |
R****** W****
|
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1 | Telephone Number |
503-8******** Extension:
|
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1 | Fax Number |
503-8********
|
||||
1 |
r******@element.com
|
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | CC | 2412 | 2462 | 0.037 | |||||||||||||||||||||||||||||||||||
1 | 2 | 15C | CC | 2402 | 2480 | 0.005 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC