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Medtronic, Inc. (“Medtronic”) offers RemoteView, which permits a user (“Programmer User”) of the Medtronic CareLink® 2090 Programmer (“Programmer”) to allow the viewing of information presently displayed on the Programmer screen with one or more individuals in remote locations anywhere in the world (“Remote Viewer”), including remote health care professionals or Medtronic representatives.
Limited License Grant. You are hereby granted a nonexclusive, nontransferable, terminable, nonassignable, nonsublicensable, limited license to install and use a copy of the Licensed Software solely for authorized and legitimate purposes. You may not otherwise copy, use, modify, reverse engineer, decompile, disassemble, create derivative works based on, or integrate with other systems or programs the Licensed Software without the prior written consent of Medtronic. You shall have sole responsibility for any fees or charges, including service or data charges, incurred by you in connection with your use of the Licensed Software. You shall not remove any proprietary or other legend or restrictive notice contained or included in the Licensed Software or other documentation associated with such Licensed Software. You agree to maintain any and all copyright, trademark, and other notices on the Licensed Software and any associated documentation.
Licensed Software Functionality and Data Use, Collection, Viewing, and Transfer.
“Active Remote Viewer” as referred to herein shall mean a Remote Viewer that has installed the Licensed Software and has at the relevant point in time an active network connection to a Medtronic server via the Licensed Software.
By installing or using the Licensed Software or clicking any acceptance button in connection with this Agreement, you acknowledge, understand, agree to, and consent to all of the following, including when you are an Active Remoter User:
) Registration. To obtain access to the Licensed Software, you must register at the Medtronic RemoteView website and establish a user name and password. All information that you provide in connection with such registration must be complete, accurate, and truthful. The user name and password are personal to you and must not be shared with anyone else. You will also not attempt, directly or indirectly, to disable, bypass, or defeat any password protection associated with the Licensed Software. Medtronic reserves the right to deny or disable any user name or password or request for any user name or password.
) Your Personal Information. Medtronic will collect information in connection with your registration and installation and use of the Licensed Software, including your first and last name, your email address, a selected security question(s) and your corresponding answer(s), your address, and your telephone number. You agree that Medtronic may store this personal information about you on a Medtronic server, including a server located in the United States of America.
) Session Key. To view the information on the Programmer, the Remote Viewer must generate a Session Key that must be shared with and entered by the Programmer User. “Session Key” as used herein means a unique token active for a limited period of time generated by the Remote Viewer. You agree not to share this Session Key with anyone other than the Programmer User who has initiated the specific session.
) Logging of Session Activity. Each time you log in to the Licensed Software, Medtronic will collect information about your activity, including in an aggregated log or database, regarding you and your session, including your name, username, computer name, IP address, operating system details, and session details (including transferring and sharing activity, start and end times, view only or control activity, and any chat messages between or among any Active Remote Viewers. You agree that Medtronic may store any personal information about you on a Medtronic server, including a server located in the United States of America.
) Active Remote Users. When you are an Active Remote Viewer: (1) you will be able to view the name and/or user name of any other Active Remote Viewer who is logged into the same Medtronic server; and (2) any other Active Remote Viewer who is actively logged into the same Medtronic server will be able to view your name and/or user name. The Licensed Software also permits one Active Remote Viewer to share the information being viewed to any other Active Remote Viewer. You must not share any information from the Medtronic programmer, including with any other Active Remote Viewer, absent the express permission from the Programmer User that is allowing you to view the information.
) Availability. Medtronic has limitations on the number of users that can concurrently log in to the Licensed Software at any given time. Thus, installation of or accessing the Licensed Software does not guarantee that it will be available to you for use at any time.
Permissions. By installing and using the Licensed Software, you represent that you have permission to do so from any associated clinic, hospital, or medical practice and that your use of the Licensed Software complies with any policies or requirements of such associated clinic, hospital, or medical practice. You are also responsible for confirming that the Programmer User has obtained any necessary patient consent before allowing you to view any patient information via the Licensed Software.
Your Acknowledgements. You acknowledge that the Licensed Software is not the exclusive method of viewing information from the Programmer and that the Licensed Software is not the exclusive method by which to obtain a patient’s implanted cardiac device data, including any data on the Programmer. You also acknowledge that the Licensed Software is not intended to be used as a life-sustaining or interventional tool during medical emergencies. You further acknowledge that Medtronic is not, and shall not be deemed to be, a provider of patient health care services by virtue of its provision of access to the Programmer screen information via the Licensed Software. You also acknowledge that information from the Licensed Software is not an electronic medical record and use of the Licensed Software does not in any way relieve you from using your best medical judgment to determine a proper course of treatment for patients.
Security/Privacy of Patient Data. Your use of the Licensed Software and any Session Keys shall be solely for legitimate and lawful purposes and not for any malicious purpose. You are solely responsible for and will use your best efforts in maintaining the confidentiality and security of any copies of the Licensed Software as well as any user name, password credentials, and any Session Keys that can be used in accessing the Licensed Software, a Medtronic server, or any information from a Programmer. You are solely responsible for and will use your best efforts in keeping any patient information you may receive or view in connection with the Licensed Software confidential and secure, and you will not attempt to capture or copy any patient information you view in any electronic or hard copy format without the express permission of the Programmer User. You will be responsible for any obligations or liabilities associated with any lost, stolen, or otherwise compromised patient information.
Reporting Issues and Feedback. You agree that you will report any issues or questions, technical or otherwise, regarding the Licensed Software promptly and directly to Medtronic. If you submit any comments or ideas to Medtronic, in the absence of a separate agreement regarding such submissions, you grant to Medtronic an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit, and distribute such ideas in any medium and agree that Medtronic is free to use them for any purpose. In addition, Medtronic has no obligation to provide continued maintenance and support to you in connection with the Licensed Software. Any maintenance and support services provided by Medtronic shall be at Medtronic’s sole discretion.
Limitations of Liability.
THE LICENSED SOFTWARE IS PROVIDED TO YOU “AS IS,” AND MEDTRONIC EXPRESSLY DISCLAIMS ANY AND ALL WARRANTIES WITH RESPECT TO THE LICENSED SOFTWARE AND YOUR USE THEREOF, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, AND NONINFRINGEMENT. MEDTRONIC DOES NOT WARRANT THAT THE USE OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR-FREE.
Legal Compliance. You shall at all times use the Licensed Software in compliance with all applicable laws. You shall ensure that your installation and use of the Licensed Software complies with all applicable export and import laws, regulations, orders, and policies of the United States of America and any other applicable jurisdiction. You represent and warrant that (i) you are not located in a country that is subject to a U.S. Government embargo, or that has been designated by the U.S. Government as a “terrorist supporting” country, and (ii) you are not listed on any U.S. Government list of prohibited or restricted parties.
Term, Termination, Modifications, and Support. This Agreement shall be in effect from the date when you first install or use the Licensed Software. Medtronic may modify, amend, or terminate this Agreement at any time, including by providing notices or an updated version of this Agreement on a Medtronic website. Medtronic may modify, disable, or terminate your use or Medtronic’s support of the Licensed Software at any time, including by providing notices on a Medtronic website. All obligations which are ongoing in nature shall survive termination or expiration of this Agreement. At any time upon Medtronic’s request (including via a notice on a Medtronic website), you agree to promptly delete and terminate use of any and all copies of the Licensed Software. In addition, upon Medtronic’s request, you agree to provide written verification that you have destroyed all copies of the Licensed Software together with the manner, date, and time of such destruction.
NayaMed International Sárl Customers: Whether the RemoteView feature shall be used in connection with NayaMed customers or devices shall be solely within the discretion of NayaMed International Sárl. If the Licensed Software is used connection with NayaMed customers or devices, this Agreement shall be directly between you and NayaMed with respect to those uses.
It’s important for the healthcare provider to be familiar with all indications, warnings, and precautions for this device.
The Strata II valve is a shunt component designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata II valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. Additionally, the Strata II valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).
Shunting of CSF into the peritoneal cavity or other areas of the body should not be carried out if there is infection in any areas in which the various components of the shunt system will be implanted. These include infections of the scalp and other skin area through which the shunt system will traverse, the meninges and cerebral ventricles, peritoneum and intraperitoneal and retroperitoneal organs, pleura and blood stream. CSF shunting is contraindicated if there is infection present in any area of the body. Additionally, shunting into the atrium of patients with congenital heart disease or other serious cardiopulmonary abnormalities is contraindicated.
The valve pressure level setting should always be verified following patient exposure to high magnetic fields.
Devices known to contain magnets should be kept away from the immediate valve implant location, as they may have an effect on the performance level setting of the Strata-type valve. All magnets have an exponentially decreasing effect on the valve the further away they are located. Common environmental levels of electromagnetic (radio frequency) radiation generated by security scanners, metal detectors, microwave ovens, mobile telephones, high voltage lines, and transformers should not affect the performance level settings.
Valve function and performance level setting should be checked in the event that the valve is subjected to significant mechanical shock or trauma.
Use Medtronic Neurosurgery PS Medical Adjustment Kit REF 45805 to change Performance Level in the Strata II valve.
The Adjustment Tool contains strong magnets. Care should be taken when using the tool near magnetically sensitive medical implants (e.g. pacemakers and vagal nerve stimulators), electronic equipment, data storage devices such as computer diskettes or credit cards.
The Locator Tool, Indicator Tool, and Adjustment Tool should NOT be sterilized.
Ferromagnetic substances may impede the ability of the adjustment tools to change and confirm the Performance Level setting.
Refer to Adjustment Kit insert for instructions, warnings, precautions and complications.
The appropriate product and size must be chosen for the specific patient's needs, based on diagnostic tests and physician experience. Product labeling specifies applicable product performance levels or ranges.
Lint, fingerprints, talc, other surface contaminants, or residues from latex gloves can cause foreign body or allergic reactions.
Improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components. Such damage may lead to loss of shunt integrity, and necessitate premature surgical revision of the shunt system.
Care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling. Introduction of contaminants could result in improper performance of the shunt system. Particulate matter that enters the shunt system may result in shunt occlusion, or may also hold pressure/flow controlling mechanisms open, resulting in overdrainage.
In securing catheters to connectors, the encircling ligatures should be securely, but not too tightly, fastened, lest they eventually cut through the silicone tubing.
Care must be taken in the routing of catheters to prevent kinking and needless abrasion along their course. Abrasion can result in premature catheter failure (fracture). The rim of the twist drill or burr hole may be trimmed to provide a beveled notch where the ventricular catheter emerges and is curved to lie adjacent to the skull.
“Small” size catheters have thinner walls and lower overall strength as compared with “Standard” size catheters. These characteristics result in a comparatively greater potential failure (fracture) rate and, therefore, shorter life expectancy for “Small” size catheters. Physicians who implant “Small” size catheters for cosmetic reasons must acknowledge the potentially higher rate of catheter revision and weight this against the cosmetic benefit.
Patients with hydrocephalus shunt systems must be kept under close observation in the postoperative period for signs and symptoms that suggest shunt malfunction. The clinical findings may indicate shunt malfunction. The clinical findings may indicate shunt obstruction or overdrainage of CSF.
Shunt obstruction may occur in any of the components of the shunt system. The system may become occluded internally due to tissue fragments, blood clots, tumor cell aggregates, bacterial colonization or other debris. Catheters which contact internal body structures can become kinked or blocked at their tips (e.g., investment of a ventricular catheter tip into the choroid plexus or of the distal catheter tip into the greater omentum or loops of the bowel). Finally, shunt obstruction may occur due to growth of an infant or child, or physical activities which result in disconnection of the shunt components or withdrawal of a distal catheter from its intended drainage site.
Shunt obstruction may occur in any of the components of the shunt system. The ventricular catheter may become occluded by particulate matter such as blood clots or brain fragments, by investment of the catheter tip in choroid plexus, by embedding of the catheter in brain tissue, or by coaptation of the ventricular walls in the presence of overdrainage (“slit ventricle”).
Disconnected shunt components may further migrate.
Shunt systems may fail due to mechanical malfunction, leading to under- or overdrainage.
Malfunction or obstruction of the shunt system may lead to signs and symptoms of increased intracranial pressure if the hydrocephalus is not compensated. In the infant, the common symptoms are increased tension of the anterior fontanelle, congestion of scalp veins, listlessness, drowsiness and irritability, vomiting and nuchal rigidity. In older children and adults, the common symptoms are headaches, vomiting, blurring of vision, nuchal rigidity, deterioration of consciousness, and various abnormal neurological findings.
Overdrainage of CSF may predispose development of a subdural hematoma or hydroma or collapse of the lateral ventricular walls leading to obstruction of the ventricular catheter.
If the ventricular catheter becomes bound to the choroid plexus or adjacent brain tissue by fibrous tissue adhesions, it is suggested that it should not be forcibly removed. It is suggested that gentle rotation of the catheter may help to free it. It is advised that the catheter be left in place rather than risk intraventricular hemorrhage which may be caused by forcible removal.
Subcutaneous catheter passers can break at welds or component assembly points, or due to extreme deformation of the malleable shaft. Sudden breakage can lead to trauma of tissues or organs, and damage to the shunt system. Instruments must be inspected prior to use to ensure continued integrity and functionality. Disposable instruments must never be reused, or injury to the patient and physician is possible.
The Strata® II valve is considered Magnetic Resonance Conditional in accordance with ASTM F2503.
MRI systems of up to 3.0 Tesla may be used any time after implantation and will not damage the Strata® II valve mechanism, but can change the performance level setting. The performance level setting should always be checked before and after MRI exposure.
The results of the tests performed to assess magnetic field interactions, artifacts, and heating, indicated the presence of the valves evaluated should present no substantial risk to a patient undergoing an MRI procedure using the following conditions:
Using the GE 3.0T Excite® HD Magnetic Resonance Imaging System, the valve experienced a maximum temperature change of 0.4°C over a 15-minute exposure period. The table provides maximum signal voids (artifact sizes) for standard imaging pulse sequences at 3.0 Tesla per ASTM F2119.
|Valve||Pulse Sequence||Plane Imagine||Max. Signal Void (Artifact), cm2|
Do NOT take the Adjustment Tool into an MRI facility as these magnets could potentially be a safety hazard to the patient and/or user.
Proximity to MRI suite may impede the mechanism in the Indicator Tool due to the field strength of an MRI magnet. Move out of the vicinity prior to attempting to verify a valve setting.
Complications associated with ventriculoperitoneal CSF shunting systems may be similar to those experienced in any surgical procedure carried out under local and/or general anesthesia. These include reactions to drugs and anesthetic agents, electrolyte imbalance and excessive blood loss, particularly in infants. A patient may rarely exhibit a reaction due to sensitivity to the implant.
In CSF shunting procedures, the most common complications are due to obstruction of the system as described under “Warnings.” Obstruction may occur in any component of the system due to plugging by brain fragments, blood clots, and/or tumor cell aggregates at some point along its course. Obstruction may also occur because of separation of the system components or kinking and/or coiling of the catheter. This may predispose migration of the ventricular catheter into the lateral ventricle and the distal catheter into the peritoneum, or other structure in which the catheter is implanted. As noted previously, growth of the infant or child may cause the distal catheter to be withdrawn from the atrium into the internal jugular vein or from the peritoneum into tissue planes where the fluid cannot be absorbed.
There are other potentially serious complications. Local and systemic infections are not uncommon with shunting procedures. Usually, they are due to organisms inhabiting the skin, particularly Staphylococcus epidermidis. Other pathogens circulating in the blood stream may colonize the shunt and, in the majority of patients, require its removal.
In 1973, Robertson et al. summarized the incidence of infection in ventriculoperitoneal shunts reported up to that time. Infection in ventriculoperitoneal shunting occurred in 5 to 10% of the patients in most of the reports.
In 1993, Kestle et al. reported significant reductions in infection (less than 4%) with the use of antibiotics, short duration of surgery (surgical experience) and control of the operating room environment (e.g., designated operating room, limited personnel and traffic, covered skin surfaces). The article states that results can also be obtained without the use of antibiotics, but with rigorous perioperative control of the environment.Using prophylactic antibiotics in shunted patients is somewhat controversial as their use may predispose infection by more resistant organisms. Therefore, the decision to use antibiotics prophylactically rests with the attending physician and/or surgeon.
Shunting into the peritoneum may fail because of investments of the catheter in loops of bowel or in the greater omentum. Perforation of the bowel by the peritoneal catheter with subsequent development of peritonitis has been described.
CSF overdrainage may result in excessive reduction of CSF pressure and predispose the development of a subdural hematoma or hygroma, and excessive reduction of ventricular size leading to obstruction because of impingement of the ventricular walls on the inlet holes in the catheter. In the infant, this excessive pressure reduction will cause marked depression of the anterior fontanelle, overriding of cranial bones and may convert communicating into obstructive hydrocephalus.
The incidence of epilepsy after ventricular shunting procedures has been reported. This study also indicated that the incidence of seizures increased with multiple catheter revisions.
StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type valve Performance Level (PL) setting and display that information numerically in terms of PL level and the equivalent pressure reading in millimeters of water (mm H2O).
The StrataVarius allows the user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.
The Medtronic Neurosurgery StrataVarius system should not be used as a diagnostic tool, but rather only for confirmation of, or to change a pressure level in, a Strata-type valve.StrataVarius should not be used on any fixed pressure valve. Use only on PS Medical Strata-type adjustable valves.
StrataVarius should not be used in a sterile environment.
Although no known complications have been reported, the StrataVarius system should be used at the discretion of the attending physician.
View the Indications, Safety, and Warnings information for Ares™ Antibiotic-Impregnated Catheters.
View the Indications, Safety, and Warnings information for StealthStation® Navigation Systems.
This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please contact us at 1-800-468-9710.
For further information, please call Medtronic NT at 1-800-468-9710, or contact your Medtronic NT sales representative.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Refer to product package insert for instructions, warnings, precautions and complications.
Disclaimer: This page may include information about products that may not be available in your region or country. Please consult the approved indications for use. Content on specific Medtronic products is not intended for users in markets that do not have authorization for use.