2 | MDT Confidential N’Vision: Therapy Management easy to use and transport programming efficiency reduces the patient management burden reduces the programming burden patient and practice friendly “Put therapy management In the palm of your hand”
3 | MDT Confidential Versatile and flexible: N’Vision does it all!
4 | MDT Confidential Hardware Highlights Therapy Stop Hard Key Touch-screen display Docking Port/Serial connection Programming Button (“P” button) Scroll Wheel (Not used with Enterra) IR Port Application Card Port Application Card Eject Button Power Key Front View Left Side P
5 | MDT Confidential Stylus Storage Magnet Port Programming Head Audio Speaker Cable Reel Battery Compartment Rear View Right Side Hardware Highlights
6 | MDT Confidential Software Highlights Windows-like interface Instant On All software on one card Store 100 programming sessions for printing later General purpose calculator
8 | MDT Confidential Start a Session Tap here Next, tap here print memory used
9 | MDT Confidential Programming Screen Therapy Measurement Window Electrode programming Pulse Width Rate Programming screen allows for quick set- up or modification of stimulation programs using the graphical tools or one-touch tables. Nominal Programming Button Current (in mA) Advanced programming Voltage
10 | MDT Confidential Profile Screen Patient Information Profile screen is used for first time setup of patient information. Information is stored on the application card for future use. Implant Date Physician Name Keyboard appears when input field is selected
11 | MDT Confidential Automated Electrode Impedance Measurement Therapy or System Impedance Measurement Battery Check The Data Screen is used to troubleshoot or establish baseline impedance measurements. Automation makes it easy! Data Screen
12 | MDT Confidential To practice programming for Enterra Therapy, use built-in demo mode in software.
13 | MDT Confidential Enterra Therapy for Gastroparesis: Product technical manual must be reviewed prior to use for detailed disclosure. Indications: The Medtronic Enterra Therapy System for gastric electrical stimulation (GES) is indicated for use in the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology. Contraindications: The Enterra Therapy System is contraindicated in patients whom the physician determines are not candidates for surgical procedures and/or anesthesia due to physical or mental health conditions. Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Diathermy is further prohibited because it can also damage the neurostimulation system components resulting in loss of therapy, requiring additional surgery for system explantation and replacement. Warnings: This system has not been evaluated for pregnancy, pediatric use, or patients under the age of 18, or over the age of 70. Strong sources of electromagnetic interference (EMI) can result in serious injury, system damage, or operational changes to the system. Strong sources of EMI include MRI, electrocautery, radiofrequency (RF)/microwave ablation, external defibrillators, ultrasonic equipment, radiation therapy, and theft detectors. Patients on anticoagulation therapy may be at a greater risk for post-operative complications. The system may be affected by or adversely affect other implantable devices such as cardiac pacemakers and cardioverters/defibrillators. Rupture or piercing of the neurostimulator can result in severe burns. The use of non-Medtronic components with this system may result in damage to Medtronic components, loss of therapy, or patient injury. When possible, identify and treat any infections remote to the implant site prior to surgery. It is recommended that the neurostimulator implant site be irrigated with antibiotic solution during surgery and that IV antibiotics be administered perioperatively. Infections at the implant site almost always require the surgical removal of the implanted system. Avoid excess lead slack in the abdominal cavity. The lead can become entangled with or erode into the bowel, which may result in bowel obstruction, bowel perforation, intra-abdominal infection, bowel resection and may require system revision. Precautions: Clinicians and patients should follow programming guidelines and precautions provided in product manuals. Patients should avoid manipulating or rubbing the neurostimulator system components, which can cause component damage, skin erosion, or stimulation at the implant site. Patients should be detoxified from narcotics prior to implant so that the effects of stimulation can be properly assessed. Patients should avoid activities that may put undue stress on the implanted neurostimulation system components. Patients should not scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0 atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other activities may cause shocking or jolting. Adverse Events: Adverse events related to the system include infection, stomach wall perforation, migration/erosion of the neurostimulator, programming difficulty, undesirable change in stimulation, implant site pain, hemorrhage, hematoma, migration/dislodgement of the lead, extra- abdominal pain, seroma, concomitant muscle stimulation, allergenic or immune system response to implanted materials, loss of therapeutic effect, and gastrointestinal complications including upper and lower gastro-intestinal (GI) symptoms. 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. The effectiveness of this device for this use has not been demonstrated. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. USA Rx Only. Rev 0709