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Manual library

Instructions for use and product manuals for healthcare professionals.

Enterra™ II Gastric Neurostimulator: prescribing and indications manuals

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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

TitleManual 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 E

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?