MicroTransponder Vivistim Paired VNS System Manuals

Manuals and User Guides for MicroTransponder Vivistim Paired VNS System. We have 1 MicroTransponder Vivistim Paired VNS System manual available for free PDF download: Manual

MicroTransponder Vivistim Paired VNS System Manual (63 pages)

Non-implantable Device

Brand: MicroTransponder | Category: Medical Equipment | Size: 1 MB

Table of Contents
3
Device Description
7
Figure 1.1: (A) Device Placement, (B) In-Office Set-Up
7
Intended Use / Indication
8
SAPS Warnings
9
SAPS Package Contents
9
WT Package Contents
9
Getting Started
10
Stroke Application & Programming Software (SAPS) Hardware Setup
10
Figure 2.1: SAPS Hardware Set-Up Overview
10
How to Use the Stroke Application & Programming Software (SAPS)
11
Figure 2.22: Startup Menu Screen-Welcome Menu
11
Using the Software (Saps)
13
Figure 3.1: Log in
13
Buttons Versus Tabs
14
Figure 3.2: Startup Menu Screen-Physician Mode
14
Figure 3.3: Buttons Versus Tabs
14
Parameter Text Color
15
Overview of SAPS Menus (Tabs) Used for Therapy
15
Program Implant Overview
15
VNS Pairing Therapy Overview
15
Figure 3.4: Blue Text Indicates Settings Have Not Been Saved
15
Patient Log File Overview
16
Programming the Implant
17
Connecting to a Specific IPG
17
Figure 4.1: Program Implant
17
Figure 4.2: Disconnect
17
Figure 4.3: Blank Serial
17
Figure 4.4: Interrogate Button on Screen
18
Figure 4.5: Contact Implant
18
Figure 4.6: Select Button
18
Figure 4.7: Serial # and Battery Status
19
Figure 4.8: Time Button
19
Figure 4.9: Time
19
Patient Information (Optional)
20
Implant Settings
20
Figure 4.10: Patient ID
20
Figure 4.11: Implant Setting Parameters
21
Figure 4.12: Amplitude
21
Figure 4.13: Frequency
22
Figure 4.14: Train Duration
22
Therapy Modes
23
Stim Test Mode
23
Figure 4.15: Pulse Width
23
Figure 4.16: Stim Test Mode
24
Figure 4.17: Implant Settings
24
Therapist Trigger Mode
25
Figure 4.18: Therapist Trigger Mode
25
Impedance
26
Figure 4.19: Implant Settings
26
Figure 4.20: Lead Impedance Check
27
Figure 4.21: High Lead Impedance Notification
27
Figure 4.22: Low Lead Impedance Notification
28
Figure 4.23: Lead Impedance Displayed
28
Delivering Paired Vns
29
Therapist Triggered Therapy
29
Select VNS Pairing Therapy Menu
29
Select Task
29
Start Task
30
Deliver Stimulation
31
End Task
33
Magnet Mode
34
Stopping Stimulation
36
Magnet Mode
36
Therapist Trigger Mode
36
Resetting the IPG / Safe Mode
36
Figure 6.1: Reset Button
37
Figure 6.2: Password Prompt
37
Figure 6.3: Accept Reset
38
Sending the Patient Home
39
Things to Review with the Patient
39
Magnet Mode
40
Figure 7.1: Magnet Mode
40
Figure 7.2: Magnet Mode Session History
41
Figure 7.3: Magnet Mode Prompt
41
Patient Log File
43
Figure 8.1: Patient Log File-Read Statistics
43
Figure 8.2: Patient Log File-Export Log
44
Intentionally Blank
45
Ipg Settings for Mri Procedures
46
Figure 10.1: IPG Settings for MRI Procedures
46
Maintenance , Handling , and Storage
47
Precautions , Warnings , Contraindications , and Hazards
48
Troubleshooting
50
General Recommendations
50
Non-Responsive Laptop
50
Other Hardware Issues
50
Troubleshooting at Patient Follow-Up Visits
50
Telemetry Lost in Therapy Visits
50
Figure 13.1: Telemetry Lost
50
Unable to Initiate Communication
51
Device Lifetime
51
IPG Lifetime, Removal, and Replacement
51
Signs of End of Life for the Vivistim System
51
Replacement Based on Battery Status Indicators
51
Device Disposal
52
Vivistim ® System Devices
53
Conventions
53
Communication Signals
53
Wireless Transmitter
53
Figure 16.1: Wireless Transmitter
53
Stroke Application & Programming Software (SAPS)
54
Other Applicable Microtransponder
54
Products
54
Applicable Commercial Devices for Use with Microtransponder IPG
54
Table 16.1: Characteristics of the Wireless Transmitter
54
Guidance and Manufacturer ' S Declaration -Electromagnetic Immunity
55
Table 17.1: Guidance and Manufacturer's Declaration-Electromagnetic Emissions
55
Table 17.2: Guidance and Manufacturer's Declaration-ESD and Power Fluctuations
56
Table 17.3: Guidance and Manufacturer's Declaration-Radiated Electromagnetic Fields
57
Table 17.4: Recommended Separation Distance between Portable and Mobile RF Communication Equipment and the Wireless Transmitter
58
Information and Support
59
Glossary
60
Definitions
60
Symbols
61

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MicroTransponder Vivistim Paired VNS System Manual (63 pages)

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