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Manual
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6
English
Inspir
e S
yst
em Models 3024, 4063, 4323
200-0
79-1
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.
62
5 x
6 i
n
ches
(1
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7
m
m
x 1
5
2
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m
)
Insp
ir
e Med
i
cal Co
nf
i
d
en
tial
The f
ollo
w
ing is a tr
ademark
of Insp
ire
Medical S
y
st
ems, Inc.
: Inspir
e
®
5
7
Table of Contents
Main Page
Default Chapter
3
Table of Contents
3
Explanation of Symbols on Product or Package Labeling
5
Indications for Use
7
Therapy Overview
7
Overview of the Manual
8
Sterile Package Contents
8
Implanted Component Descriptions
9
Ipg
9
Leads
10
Contraindications
11
Adverse Effects
11
Warnings and Precautions
12
Warnings
12
Precautions
13
Storage and Handling
15
Ipg
15
Leads
16
Physician Training
17
System Implant
17
Implantable Components
17
Procedure Overview
18
Patient Preparation
18
Surgical Materials
18
Precautions for Handling Components
18
Stimulation Lead Implant
20
Test Stimulation
22
Securing the Stimulation Lead
23
Making the IPG Pocket
25
Tunneling the Lead
25
Respiratory Sensing Lead Implant
26
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
Surgical Revision and Explant
35
Lead Repositioning
35
System or IPG Explant
35
Explant Disposition
35
Clinical Summary
36
Stimulation Therapy for Apnea Reduction (STAR) Clinical Trial
36
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
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