Online Manuals

Safety Alert letters listed below are being provided to the reader on important safety information about the VNS system. This information should be used as supplemental information and therefore physicians should be familiar with the contents of these letters.

Safety Alert, Demipulse Inaccurate Battery Longevity Projection

Safety Alert, EOS Indicator Use of Electrocautery or Exposure to Static Electricity Surgeon Letter

Safety Alert, DemiPulse EOS Indicator Following Physician

VNS Therapy Model 250 Programming System Low Impedance measurements.

Generator reset events on VNS Therapy™Demipulse/Demipulse Duo Generators (Model 103 and Model 104) for generators sold before April 15, 2008.

Lead strain relief configuration on VNS Therapy Lead™ Model 302 and the VNS Therapy Perennia Lead™ Model 303.

Lead breaks and dissolution events on the VNS Therapy™ System Lead Model 300 and Model 302 and the VNS Perennia Lead™ Model 303.

8.0 milliamp programming anomaly on the NCP pulse generators Model 100 and Model 101 and the VNS Therapy™ Pulse Generators Model 102 and Model 102R.

Handheld Screen Freeze using the VNS Therapy™ Programming System (Model 250) containing the Dell X5 handheld computer.

Document Name

Size (MB)

Implantable Components

Epilepsy Physician's Manual, NeuroCybernetic Prosthesis System NCP Pulse Generator Models 100 and 101

1.11

Insert, Model 100-101 24-Hour Rollover

0.05

Insert, Model 100-101 Low Impedance Update

0.08

Insert, Model 100-101 Tolerances Update

0.08

Physician's Manual, VNS Therapy Demipulse Model 103 Generator and VNS Therapy Demipulse Duo Model 104 Generator

0.05

Part I – Introduction—Indications, Warnings, and Precautions

0.19

Part II -- Technical Information -- VNS Therapy Demipulse Model 103 Generator and Demipulse Duo Model 104 Generator

0.97

Part III – Depression Information

0.39

Part IV – Epilepsy Information

0.2

Part V -- Implantation Procedure

1.51

Part VI – Revision - Replacement - Removal Procedure

0.23

Part VII – MRI with the VNS Therapy System

0.06

Part VIII – Glossary—VNS Therapy System

0.15

Physician’s Manual, VNS Therapy Pulse Model 102 Generator and VNS Therapy Pulse Duo Model 102R Generator

0.05

Insert, Model 102-102R, 24-Hour Rollover

0.05

Part I – Introduction—Indications, Warnings, and Precautions

0.19

Part II – Technical Information—VNS Therapy Pulse Model 102 Generator and Pulse Duo Model 102R Generator

0.72

Part III – Depression Information

0.39

Part IV – Epilepsy Information

0.2

Part V – Implantation Procedure

1.44

Part VI – Revision - Replacement - Removal Procedure

0.23

Part VII – MRI with the VNS Therapy System

0.06

Part VIII – Glossary—VNS Therapy System

0.15

Insert, Lead Precaution Update, Model 300

0.17

Physician's Manual, NeuroCybernetic Prosthesis (NCP) Bipolar Lead, Model 300

0.43

Physician’s Manual, VNS Therapy Lead, Model 302 and 304

0.05

Part I – Introduction—Indications, Warnings, and Precautions

0.19

Part II – Technical Information—VNS Therapy Lead, Model 302 and 304

0.1

Part III – Implantation Procedure

1.44

Part IV – Revision - Replacement - Removal Procedure

0.23

Part V – MRI with the VNS Therapy System

0.06

Part VI – Glossary—VNS Therapy System

0.15

Physician’s Manual, VNS Therapy Perennia Lead, Model 303

0.05

Part I – Introduction—Indications, Warnings, and Precautions

0.19

Part II – Technical Information—VNS Therapy Lead, Model 303

0.14

Part III – Implantation Procedure

1.44

Part IV – Revision - Replacement - Removal Procedure

0.23

Part V – MRI with the VNS Therapy System

0.06

Part VI – Glossary—VNS Therapy System

0.15

Disposable Components

Directions for Use, VNS Therapy Accessory Pack, Model 502

0.2

Directions for Use, VNS Therapy Tunneler, Model 402

0.2

Programming Components

Handheld Computer Connection Instructions - Dell Axim

0.23

Handheld Computer Connection Instructions - Dell Axim X50

0.23

Handheld Computer Connection Instructions - HP

0.26

Handheld Computer System Information Guide – Dell Axim

--

Handheld Computer System Information Guide – Dell Axim X50

--

Handheld Computer User Guide - HP

--

Insert, Update--Model 250 Programming Software, Versions 6.1 and 7.0

0.07

Instruction Card, Model 250 V7+ Programming Software

0.05

Physician’s Manual, NeuroCybernetic Prosthesis (NCP) Programming Software, Model 250 Version 4.6—Laptop Computer

0.18

Physician’s Manual, VNS Therapy Programming Software, Model 250 Version 6.1 (including Version 6.1.7)—Handheld Computer

1.58

Physician’s Manual, VNS Therapy Programming Software, Model 250 Version 7.0—Handheld Computer

0.32

Physician’s Manual, VNS Therapy Programming Software, Model 250 Version 7.1—Handheld Computer

0.81

Programming Instruction Card, Model 250 Version 6.1

0.08

Physician's Manual, NeuroCybernetic Prosthesis (NCP) Programming Wand, Model 201

0.46

Other

Implant Warranty and Registration Card

0.16

Returned Product Form, English

0.07

Patient Information

Depression Patient's Manual For Vagus Nerve Stimulation with the VNS Therapy System

1.83

Epilepsy Patient’s Manual for Vagus Nerve Stimulation with the VNS Therapy System

1.86

E-Labeling Software Version 2.0