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The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-111
In Commercial Distribution
- 00855728005741 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-101
In Commercial Distribution
- 00855728005642 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-053
In Commercial Distribution
- 00855728005611 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-003
In Commercial Distribution
- 00855728005598 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-073
In Commercial Distribution
- 00855728005550 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead.
The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years.
The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.
Inspire Medical Systems, Inc.
900-003-020
In Commercial Distribution
- 00855728005437 ()
3024
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-071
In Commercial Distribution
- 00855728005413 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-061
In Commercial Distribution
- 00855728005338 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-051
In Commercial Distribution
- 00855728005307 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non‐invasively interrogate
and program the IPG. It is the only component in the Inspire system that contains software. This
programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates
with the IPG through the skin via short‐range radio‐frequency (RF) telemetry; telemetry communication
allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered
by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician
programmer tablet. The physician programmer has the capability to monitor respiratory waveforms,
program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-041
In Commercial Distribution
- 00855728005277 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system