Related Manuals for Inspire 4063
Summary of Contents for Inspire 4063
- Page 1 SYSTEM IMPLANT MANUAL Inspire II Implantable Pulse Generator Model 3024 Stimulation Lead Model 4063 Sensing Lead Model 4323 Rx Only...
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Page 3: Table Of Contents
Connecting the Leads and IPG 29 Implanting the IPG 32 Completing the Implant Procedure 33 Postoperative Follow-up 33 Physician Instructions to Patient 34 Patient Registration 34 Therapy Activation 34 Therapy Titration 34 Inspire System Models 3024, 4063, 4323 English 3... - Page 4 Patients Studied 36 Study Design and Methods 37 Study Results 38 IPG Specifications 42 Factory Settings 42 Configurable Settings 43 Battery Information 44 Physical Description 45 Inspire Medical Systems Limited Warranty 46 4 English Inspire System Models 3024, 4063, 4323...
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Page 5: Explanation Of Symbols On Product Or Package Labeling
Lead that inserts into SENSE (sensing) port of IPG Lead that inserts into STIM (stimulation) port of IPG Caution, consult accompanying documents Consult instructions for use Date of manufacture Manufacturer Reference number The Inspire therapy system is MR unsafe Inspire System Models 3024, 4063, 4323 English 5... - Page 6 ® The following is a trademark of Inspire Medical Systems, Inc.: Inspire 6 English Inspire System Models 3024, 4063, 4323...
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Page 7: Indications For Use
(OSA) (apnea-hypopnea index [AHI] of greater than or equal to 15 and less than or equal to 65). Inspire UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level. -
Page 8: Overview Of The Manual
The patient uses their Inspire sleep remote to turn therapy on before they go to sleep and to turn therapy off when they wake up. The sleep remote also provides the ability to pause therapy and adjust stimulation amplitude within physician defined limits. -
Page 9: Implanted Component Descriptions
Implanted Component Descriptions The implanted components of the Inspire system consist of an IPG, a respiratory sensing lead, and a stimulation lead. All implanted Inspire system components are intended for single-use only. The IPG (Figure 2) contains the battery and electronics that deliver Inspire therapy and store the therapy settings. -
Page 10: Leads
The stimulation lead (Figure 5) delivers stimulation to the hypoglossal nerve. The lead has a flexible, self-sizing stimulation cuff. The stimulating electrodes are on the inner surface of the cuff. Connector pin Sealing rings Connector Sigmoid lead body Self-sizing cuff Anchor Figure 5. Stimulation lead 10 English Inspire System Models 3024, 4063, 4323... -
Page 11: Contraindications
• Patients who will require magnetic resonance imaging (MRI) • Patients with an implantable device that may be susceptible to unintended interaction with the Inspire system. Consult the device manufacturer to assess the possibility of interaction. Adverse Effects Possible adverse effects include, but are not limited to, the following patient related conditions: •... -
Page 12: Warnings And Precautions
• Body Mass Index (BMI) — BMI greater than 32 was not studied as part of the pivotal trial. Based on data from the feasibility study, it may be associated with decreased likelihood of response to treatment. Use of Inspire UAS in higher BMI patients is not recommended due to unknown effectiveness and safety. -
Page 13: Precautions
(e.g., less than 12 years of age). • Expiration date — Do not use any Inspire system product after its expiration date. • Component handling — Precautions related to component handling during the implant procedure are located on page 18. - Page 14 IPG. Inspire therapy is intended for use during sleep only and should be turned off otherwise. • Equipment operation — Patients should not operate potentially dangerous equipment, such as power tools, during stimulation.
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Page 15: Storage And Handling
Inspect the IPG and the lead sterile packages prior to opening. If the IPG package is damaged, the IPG may be damaged as well. Return a damaged package to Inspire Medical Systems; see the back cover of this manual for addresses. -
Page 16: Leads
Leads If the lead sterile package seal is broken or the package is otherwise damaged, return the package to Inspire Medical Systems. Leads cannot be resterilized. Table 2. Lead Storage, Handling, and Resterilization Handling and Storage: Acceptable Unacceptable Store and transport leads within the Do not implant a lead that was dropped. -
Page 17: Physician Training
Physician Training Prior to implanting an Inspire system, surgeons will receive classroom instruction on Inspire implant techniques as well as cadaver training. Sleep physicians and sleep technicians will receive classroom instruction on how to titrate the device including hands on operation of the programmer. -
Page 18: Procedure Overview
The implant procedure begins with preoperative planning. It is recommended that the stimulation lead be the first Inspire component to be implanted. Secondly, a subcutaneous pocket is created for the IPG. The connector end of the leads will be tunneled to this pocket. - Page 19 IPG. • After tunneling, if the lead is not immediately connected to the IPG, the black, U-shaped shorting bar must be reattached. Inspire System Models 3024, 4063, 4323 English 19...
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Page 20: Stimulation Lead Implant
To place the stimulation lead cuff, the cuff’s short inner and long outer flaps (Figure 8) are wrapped around the hypoglossal nerve. Short inner flap Long outer Electrodes flap Figure 8. Stimulation lead cuff flaps 20 English Inspire System Models 3024, 4063, 4323... - Page 21 4. Make sure both flaps encircle the nerve. 5. Irrigate the cuff and nerve with sterile saline to facilitate adequate electrical contact between the electrodes and the nerve. Figure 9. Placing the cuff around the hypoglossal nerve Inspire System Models 3024, 4063, 4323 English 21...
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Page 22: Test Stimulation
The external stimulator will require sterile wires to interface with the connector of the stimulation lead. c. Repeat the stimulation process described in steps 3 and 4 above to ensure proper placement of the cuff. 22 English Inspire System Models 3024, 4063, 4323... -
Page 23: Securing The Stimulation Lead
• Surgical instruments should not be used to handle the lead body directly. The lead is easily kinked and the insulation is easily damaged. Care should be used when handling the lead. Surgical instruments may be used for handling the lead anchor. Inspire System Models 3024, 4063, 4323 English 23... - Page 24 Lead anchor (attached to digastric muscle) Digastric muscle Strain relief loop Hypoglossal nerve Cuff Lead passes under digastric muscle and does not touch itself when crossing Figure 11. Anchoring the stimulation lead 24 English Inspire System Models 3024, 4063, 4323...
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Page 25: Making The Ipg Pocket
• To avoid damage to the collet, do not attach it to the tunneling tool until the tunnel is established from the lead implant site to the IPG pocket. Inspire System Models 3024, 4063, 4323 English 25... -
Page 26: Respiratory Sensing Lead Implant
Leave the black U-shaped clip on the connector in place except during tunneling and connection to the IPG. • Do not touch the recessed sensing membrane of the sensor with surgical tools as this will damage the sensor. 26 English Inspire System Models 3024, 4063, 4323... - Page 27 3. Use sharp and blunt dissection to expose the intercostal muscle layers. • Dissection is required to reach and identify the internal intercostal muscle. • The sensor will be inserted between the internal intercostal muscle and the external intercostal muscle layers. Inspire System Models 3024, 4063, 4323 English 27...
- Page 28 9. Tunnel the connector end of the respiratory sensing lead to the IPG pocket using the tunneling tool. Refer to “Tunneling the Lead” on page 25 for instructions. 28 English Inspire System Models 3024, 4063, 4323...
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Page 29: Connecting The Leads And Ipg
• Prior to tightening the setscrew nearest to the lead port, gently tug the lead to confirm that the first setscrew has secured the lead in place. • After tightening both setscrews, confirm that the seals covering the setscrews are fully closed. Inspire System Models 3024, 4063, 4323 English 29... - Page 30 Place the telemetry cable into a sterile sleeve and hold the telemetry head centered over the IPG. b. Verify sensor function by observing a sensor waveform on the using the programmer. c. Once function has been verified, turn the therapy off. 30 English Inspire System Models 3024, 4063, 4323...
- Page 31 • After tightening both setscrews, confirm that the seals covering the setscrews are fully closed. Figure 18. Tighten the two upper setscrews Inspire System Models 3024, 4063, 4323 English 31...
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Page 32: Implanting The Ipg
Place the telemetry cable into a sterile sleeve and hold the telemetry head centered over the IPG. b. To check stimulation function, evaluate both the stimulation response and the sensor waveforms. Refer to the physician programming manual for instructions. 32 English Inspire System Models 3024, 4063, 4323... -
Page 33: Completing The Implant Procedure
To allow for healing after surgery, the system should not be activated for about 1 month following implant. Refer to the Inspire programmer manual for additional information. Regular patient follow-up should be scheduled to monitor the condition of the IPG battery and to confirm that the therapy values are appropriate. -
Page 34: Physician Instructions To Patient
Upon completion of the registration form by the clinician, this form serves as a permanent record of facts related to the implanted device. A copy of this form should be returned to Inspire Medical Systems. Refer to the back cover of this manual for mailing address. -
Page 35: Surgical Revision And Explant
When replacing an IPG, (due to battery depletion or explanting the IPG at the death of a patient who is to be cremated) return the IPG to Inspire Medical Systems for analysis and disposal. See the back cover of this manual for mailing address. -
Page 36: Clinical Summary
Clinical Summary Stimulation Therapy for Apnea Reduction (STAR) Clinical Trial The Inspire Upper Airway Stimulation (UAS) system was evaluated in a multicenter trial at study centers in the United States and Europe for the indication of moderate to severe obstructive sleep apnea (OSA) in patients who were not effectively treated by continuous positive airway pressure (CPAP). -
Page 37: Study Design And Methods
13-month visit. The therapy withdrawal group had the sleep study performed with Inspire therapy OFF, and the therapy maintenance group had the sleep study performed with the Inspire therapy ON. The mean change of AHI for each arm was compared to determine the extent of treatment effect from Inspire therapy. -
Page 38: Study Results
3.3 (range 2–6) titration studies. Safety Of the 126 patients implanted with the Inspire UAS system in the STAR trial, 124 were followed through 18 months. There were no unanticipated events and only 2 events required surgical intervention. - Page 39 There were 3 deaths over the course of the study, all of which were unrelated to Inspire therapy. There were 32 serious adverse events (SAE), 2 of which were related to Inspire therapy.
- Page 40 18 months show the durability of Inspire therapy's treatment effect. The randomized controlled therapy withdrawal study provided further evidence that improvements were attributed directly to the Inspire therapy. AHI increased significantly in the therapy withdrawal (OFF) group compared to AHI scores in the therapy maintenance (ON) group.
- Page 41 (p-value of 0.22). Conclusion Upper Airway Stimulation is a safe and effective treatment for patients with moderate to severe OSA who are not effectively treated by CPAP. Inspire System Models 3024, 4063, 4323 English 41...
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Page 42: Ipg Specifications
IPG Specifications Factory Settings Table 9. Inspire II IPG (Model 3024) Factory Settings Parameter Value General Therapy On/Off Usage Start Delay 30 mins Pause Time 15 mins Therapy Duration 8 hrs Stimulation Amplitude Rate 30 Hz Pulse Width 90 μs... -
Page 43: Configurable Settings
Configurable Settings The parameters in Table 10 can be changed using an Inspire programmer. See the physician programmer manual for more information. Table 10. Inspire II IPG (Model 3024) Configurable Settings Parameter Values Increment Stimulation Start Delay 0–75 mins 5 mins Pause Time 5–30 mins... -
Page 44: Battery Information
Battery Information Table 11. Inspire II IPG (Model 3024) Battery Information Description Value Chemistry Lithium primary cell Manufacturer Inspire Medical Systems Longevity 10.6 years average (0.7 years standard deviation) Longevity data is based on STAR trial therapy settings at the 12-month endpoint. IPG longevity will vary based on usage and therapy settings. -
Page 45: Physical Description
Physical Description Table 12. Inspire II IPG (Model 3024) Physical Description Description Value Height 52 mm (2 in) Length 60 mm (2.4 in) Thickness 10 mm (0.4 in) Volume 23 cm (1.66 in Mass 49 g (2 oz) Radiopaque identification... -
Page 46: Inspire Medical Systems Limited Warranty
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. - Page 47 Maple Grove, MN 55369 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.
- Page 48 48 English Inspire System Models 3024, 4063, 4323...
- Page 50 Manufacturer Inspire Medical Systems, Inc. 9700 63rd Avenue North Maple Grove, MN 55369 Tel. 844-672-4357 763-205-7970 Fax 763-537-4310 www.inspiresleep.com © Inspire Medical Systems 2017 All Rights Reserved 200-079-101 Rev B...
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