Manual library
Patient therapy guide
| Title |
|---|
| Enterra® Therapy: Gastric Electrical Stimulation System This manual helps patients understand the Enterra® Therapy System. It provides information about the system’s parts and explains how they are implanted. It also provides answers to some common questions. Manual Document Number: 800-0013-003, Rev A |
Prescribers manual
| Title |
|---|
| Using Neurostimulation for Gastric Electrical Stimulation: Enterra® Therapy Information for Prescribers This manual presents information on the contraindications, warnings, precautions, and patient counseling and selection criteria associated with the use of Enterra Therapy. Manual Document Number: 800-0012-003, Rev C |
Implant manuals
| Title |
|---|
| Enterra® II 37800 This manual presents information on the specifications of the Enterra II Neurostimulator and instructions for implanting the device. Manual Document Number: 800-0009-003, Rev A |
| Enterra® Therapy 4351: Unipolar Lead Kit for Gastric Electrical Stimulation This manual presents information on the specifications of the Enterra II Neurostimulator and instructions for implanting the device using Enterra lead model 4351. Manual Document Number: 800-0017-003, Rev A |
| N’Vision® Clinician Programmer with Software 8840 & 8870 This manual presents instructions for programming the Enterra® II Neurostimulator. Manual Document Number: 800-0020-001, Rev A |
MRI guidelines
| Title |
|---|
| Patient Guide | Enterra® Therapy: Gastric Electrical Stimulation System This manual helps patients understand the guidelines and conditions in which they may receive an MRI with the Enterra II System. Manual Document Number: 800-00939-001, Rev B |
| Physician Guide | Enterra® Therapy: Gastric Electrical Stimulation System This manual presents information on MRI guidelines and conditions of the Enterra II System. Manual Document Number: 800-00938-001, Rev C |
Not all products listed for manuals are approved in all geographies.
MKT-D-0006, Rev L
IMPORTANT SAFETY INFORMATION
Enterra Therapy for treatment of chronic, resistant to medication nausea and vomiting associated with gastroparesis caused by diabetes or an unknown origin in patients aged 18 to 70 years: patients should always discuss potential risks and benefits of the device with their physician.
HUMANITARIAN DEVICE
Authorized by Federal law for use in the treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology in patients aged 18 to 70 years. The effectiveness of this device for this use has not been demonstrated. What does this mean?