Resources
Manual library
Instructions for use and product manuals for healthcare professionals.
Enterra™ II Gastric Neurostimulator: prescribing and indications manuals
| Title | Manual type |
|---|---|
| Indications – Enterra® Therapy This manual presents information on the disease states approved for treatment with the therapy and system. Manual Document Number: M954474A001 REV. B | Indications |
| Enterra™ Therapy using neurostimulation for gastric electrical stimulation – Information for prescribers This manual presents information on the contraindications, warnings, precautions, and patient counseling and selection criteria associated with the use of the system. Manual Document Number: M942857A011 REV. A | Information for prescribers |
Implant manual
| Title | Manual type |
|---|---|
| Enterra™ II 37800 Neurostimulator – Implant manual This manual presents information on the specifications of the implantable device and instructions for implanting the device. Manual Document Number: M943021A019 REV. A | Implant manual |
Clinician programming manual
| Title | Manual type |
|---|---|
| N’Vision® Clinician Programmer with software 8840 8870 Enterra® II Neurostimulation system – 03/14 Programmer guide for software version A This manual presents instructions for programming the implantable device. Manual Document Number: M943022A027 REV. A | Programming manual |
Patient therapy guide
| Title | Manual type |
|---|---|
| Enterra Therapy gastric electrical stimulation system – Patient therapy guide This manual presents information to help patients understand the Enterra Therapy system. It provides information about the system’s parts and explains how they are implanted. It also suggests various questions patients should discuss with their doctor. Manual Document Number: M943023A025 REV. A | Patient therapy guide |
Clinical study / summary
| Title | Manual type |
|---|---|
| Enterra® Therapy gastric electrical stimulation system – Clinical summary This manual presents information related to the clinical studies performed in association with the therapy and implantable system. Manual Document Number: M954480A001 REV. A | Clinical study / summary |
Technical manual
| Title | Manual type |
|---|---|
| Electromagnetic compatibility declaration (EN 60601-1-2) – Reference manual This manual presents declaration information, such as electromagnetic compatibility, associated with the system. Manual Document Number: M954928A005 REV. C | Declarations |
Enterra™ Gastric Neurostimulator: prescribing and indications manuals
| Title | Manual type |
|---|---|
| Indications – Enterra® Therapy This manual presents information on the disease states approved for treatment with the therapy and system. Manual Document Number: M954474A001 REV. B | Indications |
| Enterra™ Therapy using neurostimulation for gastric electrical stimulation – Information for prescribers This manual presents information on the contraindications, warnings, precautions, and patient counseling and selection criteria associated with the use of the system. Manual Document Number: M942857A011 REV. A | Information for prescribers |
Implant manuals
| Title | Manual type |
|---|---|
| Enterra® Therapy 4351 unipolar lead kit for gastric electrical stimulation – Implant manual This manual presents information on the specifications of the implantable device and instructions for implanting the device. Manual Document Number: MA01352A013 REV. A | Implant manual |
| Enterra® Therapy 3116 gastric electrical stimulation system This manual presents information on the specifications of the implantable device and instructions for implanting the device. Manual Document Number: M220490A005 REV. D | Implant manual |
Clinician programming manuals
| Title | Manual type |
|---|---|
| N’Vision® Clinician Programmer with software 8840 8870 Enterra® Therapy Neurostimulation system for gastric electrical stimulation (GES) – 02/03 Programmer guide for software version A This manual presents instructions for programming the implantable device. Manual Document Number: M939930A031 REV. A | Programming manual |
| N’Vision® Clinician Programmer with software 8840 8870 Enterra® II Neurostimulation system – 03/14 Programmer guide for software version A This manual presents instructions for programming the implantable device. Manual Document Number: M943022A027 REV. A | Programming manual |
Clinical study / summary
| Title | Manual type |
|---|---|
| Enterra® Therapy gastric electrical stimulation system – Clinical summary This manual presents information related to the clinical studies performed in association with the therapy and implantable system. Manual Document Number: M954480A001 REV. A | Clinical study / summary |
Technical manual
| Title | Manual type |
|---|---|
| Electromagnetic compatibility declaration (EN 60601-1-2) – Reference manual This manual presents declaration information, such as electromagnetic compatibility, associated with the system. Manual Document Number: M954928A005 REV. C | Declarations |
Not all products listed for manuals are approved in all geographies.
MKT-D-0006, Rev F
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?