Strata® Valves and Magnetic Fields

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Strata Valves and Magnetic Fields ® The Medtronic Strata® products are a valve technology used in the Because magnets are used to adjust the valve setting, it…

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Strata Valves and Magnetic Fields ® The Medtronic Strata® products are a valve technology used in the Because magnets are used to adjust the valve setting, it is reasonable for a treatment of hydrocephalus. Strata valve products contain a magnet inside the person to be concerned about the potential effects other magnets may have valve mechanism that allows the neurosurgeon to change the pressure setting of on their Strata valve setting. It is very important to know that the strength of a the valve in his office. Changing the pressure setting of the valve does not require magnet weakens dramatically with distance. Medtronic has tested a number of a revision or surgical procedure. The change is made using a set of simple hand representative products to demonstrate that the risk to a Strata patient is very tools that rely on magnetic coupling with the valve through the skin. The same minimal. The following table highlights examples of how magnetic strength hand tools are used to verify that the change has been made correctly, without weakens with distance. the need for x-ray confirmation. Typical Magnetic Typical Magnetic Since the Strata valves contain a magnet, the patient should observe certain Product Tested4 Strength Strength at 2” (5 cm) precautions. at Source (Gauss) Distance (Gauss) iPad® 2 & Smart Cover 2060 1.3 Magnetic Resonance Imaging (MRI) Cellphone – Clam Shell Type 525 1.5 Extensive testing of the Strata valve was conducted using MRI with a static Headphones (Earbud-Type) 350 0.0 magnetic field capacity of 3.0 Tesla. Results of the testing indicate that the valve is “MRI Safe”. That is, exposure of the valve to MRI will not damage the valve, but may Refrigerator Door Seal 340 0.2 change the valve pressure setting. Therefore, immediately after MRI exposure, Adjustable Strata® Valves and Adjustment Tools Flexible Decorative the valve pressure setting needs to be checked by your neurosurgeon or 305 0.0 Refrigerator Magnet attending physician. Noise-Canceling magnets are too weak to interfere with the valve 115 1.1 Headphones setting. Caution should be used around professional- Other Magnets Walk-Thru Metal Detectors 1.5 0.0 type audio headphones. Magnets are common in many products in our everyday life. Magnets are found in Handheld Security Wand 1.0 0.0 Walk-thru security detectors in stores and airports, electronic equipment, refrigerator door seals, some computer tablets such as the iPad®, audio speakers and in some children’s toys. The magnets in these devices and hand-held security wands, do not have enough can vary in strength and are so common we may not even know they are present. Medtronic realizes that there may be unique situations that can impact the Strata magnetic strength to change the pressure setting of valve setting, so it recommends that all products with magnets be kept at a the valve. The newer full body imaging systems used The Strata valve also contains an internal magnet which is designed to be minimum of 2” (5 cm)* from the Strata valve implant site. Magnetic therapy pads at some airports are x-ray based systems, and will not adjusted using a strong external magnetic tool. In order to adjust the valve setting, and pillows should not be used at all. For devices that must be used close to the interfere with the Strata valve setting. There should be a minimum of 90 gauss1-3 directly adjacent to the valve is required. “Gauss” is a head (e.g., cell phone, cochlear implant, etc.) it is recommended that they be used no concern with airport travel, or entering stores with measure of magnetic field strength. The external Strata adjustment tool is a very on the side of the head opposite the valve implant. Most headphone speaker security systems. strong magnet (over 3000 gauss) to ensure reliable valve adjustment through a patient’s scalp and hair. Electromagnetic fields such as those caused by a high voltage wire will not have any influence on the valve Radiopaque Flow Direction Indicator pressure setting. Check with your Silicone Dome Reservoir Distal Occluder While it is impossible to quantify all the various magnets health care team Proximal Occluder Integral Inlet Delta Chamber in our day-to-day lives, the vast majority will not impact about specific neuro- Connector Integral Outlet Connector the Strata valve as long as the recommended distance imaging procedures from the valve implant site of 2” or more is maintained. related to your Radiopaque Valve Firm Plastic Base Adjustable Valve Radiopaque Valve * Some unusual industrial work environments may ongoing treatment. to Catheter Indicator Mechanism to Catheter Indicator require a further separation than 2 inches (5 cm). iPad® is a registered trademark of Apple, Inc. Cutaway Illustration of a Strata® Valve 1. MNS Report RD9310-04, “Kronos” Valve Resistance to Spontaneous PL Setting changes”; Dec 15, 1998. 2. MNS Technical Document TD-02843, “Strata II Valve Design Verification Report: Strata Valves Resistance to Inadvertent Switching”; Sept 3, 2004. ® 3. MNS Technical Document TD-02864, “Magnetic Inadvertent Switching: Non- homogeneous Dynamic Magnetic Influence Characterization of the Strata NSC Valve and Codman Hakim Programmable Valve”; Nov 15, 2004. MAGNETIC FIELD INFLUENCES 4. Data available upon request. For more information, please contact us at 800-510-6735, or refer to www.medtronic.com This therapy is not for everyone. Please consult your physician. A prescription is required. Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician. Refer to product package insert for instructions, warnings, precautions and complications. Strata® is a registered trademark of Medtronic, Inc. iPad® is a registered trademark of Apple, Inc. LIT59349 Rev. D 02.12 ©Medtronic, Inc. 2012 All Rights Reserved Printed in USA For more information: www.medtronic.com
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