Inspire Medical Systems, Inc. 3024 Inspire

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.

Implant Placement Guide

GE OEC Elite CFD 31cm Flat Detector Super C-Arm - VAS 15 Software. GE OEC Elite CFD C-Arm 31 cm Flat Detector w/ Bumper VAS 15 Vascular Software, SUPER C Motorized C Refurbished, Calibrated, Ready for Use 31 cm CMOS Flat Detector (CFD) - CMOS - Complementary metal-oxide semiconductor detector - DQE(0): 72% - Active amplification inside pixel for ultra-fast electron mobility - Active Matrix: 1548x1524 pixels - Pixel Pitch: 190.0 um - Nominal resolution (at display): 31 cm: 2.7 lp/mm; 21 cm: 2.8 lp/mm; 15 cm: 2.9 lp/mm - Quad-mode magnification: Live Zoom fluidly from 1 to 4X with no change in dose; Fixed try-mode Mag settings: 31cm/21cm/15cm Workstation Display - 13.6 in Live and Reference Image displayed size - 1 to 1 detail imaging chain from CMOS detector to 4K display resolution - Squircle shaped image retains 100% of image when rotated and no cropped or changed view. - 4K, 32" Ultra high definition (UHD) Color Display - Monitor displays two split screens for equivalent view of two 20in displays - 3840x2160 display resolution - 600 cd/m2 maximum brightness - Touchscreen interface with anti-reflection, anti-fingerprint - Easily position monitor to surgical line of sight with display mount on an articulating arm with five movements What's Included: GE OEC Elite CFD C-Arm, Super C; (REF OEC Elite) Qty: 1 GE Beam Limiting Device; (REF 5455288-03) Qty: 1 GE Laser Aiming Device; (REF 5440087) Qty: 1 GE Image Receptor; (REF 5457729-02) Qty: 1 GE Remote User Interface; (REF 5719003-01) Qty: 1 GE Hand Control OEC ELITE; (REF 5819193); Qty; 1 GE Foot Switch; (REF 1482807); Qty: 1 GE Skin Spacer - Squircular; (REF 5436688-01) Qty: 2

NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include:At every bedsideOn medication cartsInjection traysPhlebotomy traysCritical Care UnitsEndoscopy SuitesPharmacyAnesthesia/SurgeryPathologyEmergency DepartmentPsychiatric wardsNeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.

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.

Mastoid diamond burr sterile 5.0 mm x 70 mm stainless steel disposable

VAGINAL SPECULUM WITH LIGHT SOURCE SINGLE-USE SIZE MEDIUM - STERILE

Burr, Oval, 10 flute, 3.0mm

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.

Implant Placement Guide

GE OEC Elite CFD 31cm Flat Detector Super C-Arm - VAS 15 Software. GE OEC Elite CFD C-Arm 31 cm Flat Detector w/ Bumper VAS 15 Vascular Software, SUPER C Motorized C Refurbished, Calibrated, Ready for Use 31 cm CMOS Flat Detector (CFD) - CMOS - Complementary metal-oxide semiconductor detector - DQE(0): 72% - Active amplification inside pixel for ultra-fast electron mobility - Active Matrix: 1548x1524 pixels - Pixel Pitch: 190.0 um - Nominal resolution (at display): 31 cm: 2.7 lp/mm; 21 cm: 2.8 lp/mm; 15 cm: 2.9 lp/mm - Quad-mode magnification: Live Zoom fluidly from 1 to 4X with no change in dose; Fixed try-mode Mag settings: 31cm/21cm/15cm Workstation Display - 13.6 in Live and Reference Image displayed size - 1 to 1 detail imaging chain from CMOS detector to 4K display resolution - Squircle shaped image retains 100% of image when rotated and no cropped or changed view. - 4K, 32" Ultra high definition (UHD) Color Display - Monitor displays two split screens for equivalent view of two 20in displays - 3840x2160 display resolution - 600 cd/m2 maximum brightness - Touchscreen interface with anti-reflection, anti-fingerprint - Easily position monitor to surgical line of sight with display mount on an articulating arm with five movements What's Included: GE OEC Elite CFD C-Arm, Super C; (REF OEC Elite) Qty: 1 GE Beam Limiting Device; (REF 5455288-03) Qty: 1 GE Laser Aiming Device; (REF 5440087) Qty: 1 GE Image Receptor; (REF 5457729-02) Qty: 1 GE Remote User Interface; (REF 5719003-01) Qty: 1 GE Hand Control OEC ELITE; (REF 5819193); Qty; 1 GE Foot Switch; (REF 1482807); Qty: 1 GE Skin Spacer - Squircular; (REF 5436688-01) Qty: 2

NeedleSafe II is a medical safety device that enables single-handed recapping of needles, I.V. catheters and phlebotomy sets. Mounted horizontally or vertically, NeedleSafe II provides vital protection whenever and wherever needed. Examples of service locations include:At every bedsideOn medication cartsInjection traysPhlebotomy traysCritical Care UnitsEndoscopy SuitesPharmacyAnesthesia/SurgeryPathologyEmergency DepartmentPsychiatric wardsNeedleSafe II may be steam autoclaved, gas sterilized, or disinfected by wiping with or soaking in alcohol.