Strata Valve ADJUSTMENT REFERENCE GUIDE

Strata Valve ADJUSTMENT REFERENCE GUIDE

Strata Valve Adjustment Tools Preoperative Procedures READING THE PERFORMANCE LEVEL 1 2 1. Position the Locator Tool above the valve while it is still in the sterile packaging, so the blue arrows are pointing in the same direction as the arrow on the valve. Ensure that the white circular portion of the valve is located between the two lines labeled Valve Mechanism. ADJUSTING THE PERFORMANCE LEVEL 3 4 2. Set the Indicator Tool (compass) into the Locator Tool while aligning the red bands on the tools. Read the current Performance Level setting of the valve, indicated by the blue triangle mark on the Indicator Tool. 3. Keeping the Locator Tool in position, remove the Indicator Tool. Place the Adjustment Tool (magnet) into the Locator Tool with the blue triangle pointing at the current Performance Level setting. 4. Turn the Adjustment Tool to the desired Performance Level setting. 5 6 5. Holding the Locator Tool in place, remove the Adjustment Tool by withdrawing it straight up and place at least 60 cm (24 ) away from the valve. 6. To confirm that the desired Performance Level setting change has been accomplished, repeat Step 2.

StrataVarius Adjustment System Postoperative Procedures READING THE PERFORMANCE LEVEL 1 2 1. Insert the Smart Card (face-up) corresponding to the valve to be read. 2. Press the POWER button and allow the system time to complete the self-test. 3 4 3. Holding the system 10 cm above the valve and with the red arrow pointing in the direction of flow, press the Calibration Button. 4. When the locating screen appears, slowly lower the system towards the patient while staying aligned and parallel to the valve. 5 6 5. Adjust the lateral position as indicated by the directional arrows on the screen, until the center of the circle is filled in and the green light is lit indicating you are directly over the valve. 6. Once centered over the valve, the Performance Level setting and the corresponding pressure in mm H20 will be displayed on the screen.

ADJUSTING THE PERFORMANCE LEVEL 7 8 7. Position the system directly over the valve, with the red arrow pointing in the direction of fluid flow. 8. Lower the Adjustment Tool (magnet) straight into the cutout, with the blue arrow pointing to the current valve setting. The magnet icon and calibration prompt will appear on the screen. 9 10 9. Hold the system in place, and rotate the Adjustment Tool until the blue arrow points to the desired Performance Level setting. 10. Remove the Adjustment Tool by withdrawing it straight up from the system, and place it at least 60 cm (24 ) away from the valve site. 11 The information provided in this document should not be considered a substitution for the Instructions for Use or for the physician s own medical judgement. 11. To confirm that the desired Performance Level setting change has been accomplished, repeat Steps 3-6.

StrataVarius Adjustment System Frequently Asked Questions Q: Can the StrataVarius System be used to read and adjust a Strata-type valve before it is implanted? A: Yes, but we suggest using the Strata Hand Tools while the valve is in the sterile packaging. Q: Can the StrataVarius System be used to read and adjust all types of implanted Strata valves? A: Yes. Q: What does the magnet symbol mean when it appears on the screen? A: It means the Adjustment Tool (magnet) has been in close proximity to the system. Recalibration is necessary to read the Performance Level setting of the valve (see Step 3). Q: Why won t the corresponding pressure (mm of H 2 O) reading display when I read the Performance Level? A: Most likely the Smart Card is not inserted properly. Verify that the Smart Cart is inserted face-up. Q: What can cause the StrataVarius to flash between two Performance Level settings? A: If the valve s magnet is between two PL settings, two PL values will alternately display in the LCD. Check the alignment of the StrataVarius. If the alternating displays continue, repeat the change to desired PL setting (see Step 7-10). Q: What can cause the Performance Level not to display? A: This can be caused by several things: 1. The system is less than 10 cm away from the valve when the calibration button is pushed (see Step 3). 2. The Adjustment Tool (magnet) is less than 60 cm (24 ) away from the system when the calibration button is pushed. (see Step 3). 3. The batteries are low. 4. The patient is laying on a metal table.

Ordering Information StrataVarius Adjustment System REF No. 45806 Included with Product: StrataVarius System Adjustment Tool Strata II Smart Card Strata NSC Smart Card Batteries Storage/Carrying Case X-Ray Templates Instruction Manual Additional Accessories: REF No. Description 45807 Strata (II) Smart Card (Replacement) 45808 Strata NSC Smart Card (Replacement) 45809 StrataVarius Magnet (Replacement) Strata Valve Adjustment Tools REF No. 45805 Indicator Tool Locator Tool Adjustment Tool For more information, contact your Medtronic Neurosurgery sales representative or refer to www.medtronicneurosurgery.com. Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117-5500 USA (800) 468-9710 USA/Canada (901) 344-0645 International (800) 468-9713 FAX (901) 396-2698 FAX International International Telephone Numbers Adriatic Region 385-1-488-1120 Australia 1-800-668-670 Baltic Region 37-1-67560226 Belgium 32-2456-09-09 Canada 1-800-217-1617 China 86-21-50800998 Czech Republic 420-2-9657-9580 France 33-155-381-700 Germany 49-2159-8149-209 Greece 30-210-67-79-099 Hong Kong 852-2919-1312 Hungary 36-30-5052987 India 91-22-26836733 Israel 972-9-972-4400 Italy 39-02-24137-324 Japan 81-3-6430-2017 Korea 82-2-3404-3600 Lebanon 961-1-370-670 Luxembourg 32-2456-09-09 Netherlands 31-45-566-8800 Poland 48-22-465-6900 Portugal 351-21-724-51-28 Russian Fed. 7-495-580-73-77 South Africa 27-11-466-1820 Spain 34-91-625-05-40 Taiwan 886-2-2183-6000 UK 44-1923-205-168 USA 1-901-344-0645 Rx only. Refer to product instruction manual/package insert for instructions, warning, precautions and contraindications. Caution: Federal Law (USA) restricts this device for sale by or on the order of a physician. Please consult www.medtronicneurosurgery.com. Strata and StrataVarius are registered trademarks of Medtronic, Inc. 2013 Medtronic, Inc. All rights reserved. UC201402051a EN 09.2013 2014-134