Ascensia Diabetes Care US N1 Wireless Blood Glucose Monitoring System User Manual

Bayer HealthCare Diabetes Care Wireless Blood Glucose Monitoring System

Contents

Manual 2

Options28 Need Help ? Bayer Diabetes Care: 1-800-348-8100Options29www.bayerdiabetes.com/usSetting the Markers and Test Reminder AlarmThe fl ashing bell symbol will now appear on the display, along with the word “ .”This option controls whether you want to hear the “beeps” during testing. Press ▲ or ▼ to choose whether to turn the buzzer on or off. (You will hear a beep when you switch to the screen.) Press M to set.Setting the 12 or 24 Hour Clock:12H will now fl ash on the display. Press ▲ or ▼ to choose the 12H or 24H setting. This option lets you set the meter to display the time as a 12 hour setting with AM and PM or as a 24 hour display (military time). Press M to set.Setting the Month and Day format:m/d will now fl ash on the display. Press ▲ or ▼ to choose how you want the date to appear (month/day or day.month). Press M to set.Setting the Sound:Setting the Time, Date, and SoundSetting the Markers and Test Reminder Alarm:You will now see three markers displayed on your meter, along with the word “ .”Your CONTOUR LINK meter can give you the option of marking your test results by turning this option on.(See pages 30–35 to learn how to use these options!)Press ▲ or ▼ to turn the marker option on or off.Press M to set. You can now select the timing for the alarm to sound. The default set-ting is 2.0 hours (); this can be changed to 1.0, 1.5 or 2.5 hours.Press ▲ or ▼ to change the alarm time.Press M to set. You have now completed the setup of your meter!The fi nal display will remain on for 3 seconds, showing all the options you have chosen. If you ever want to change the options you have chosen, simply go back to page 26 and follow the Setup instructions.Setting the Test Reminder Alarm Time:CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 28-29CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 28-29 2/7/11 4:00:25 PM2/7/11 4:00:25 PM
Options30 Need Help ? Bayer Diabetes Care: 1-800-348-8100Options31www.bayerdiabetes.com/usUsing the Markers and Test Reminder AlarmUsing the Markers and Test Reminder Alarm:If you have set your meter with the marker option on (see page 29), your meter will display three markers next to your blood glucose test result. (If the Send option is on, the markers will not be displayed until after the result has been sent to the Medtronic device and the display stops fl ashing.) Pre-meal = Marks a test result that was taken before a meal. Post-meal = Marks a test result that was taken after a meal. Logbook = Marks any result as being unique or different in some way and for which you may want to make notes in your Clinilog® logbook. Seeing a result with this symbol next to it in the memory will help remind you that there is more information recorded about this test result.Be sure to leave the used test strip in the meter until you have finished marking the results.Press M or remove the used test strip to automatically save the test result in the meter memory.ORPress ▲ or ▼ until all three markers disappear from the display. Press M and remove the used test strip.Dispose of the used test strip and lancet properly to prevent injury or contamination to others.If you want to mark the test result:If you do not want to mark the test result:Press ▲ or ▼ to move to the marker you want to set. You will know when you have chosen a marker when you see the box around it fl ashing on the display. Press M to set. If you mark a result with the , the will appear with a box fl ashing around it.This allows you to set an alarm that will go off in 2 hours (or whatever time you have selected in the Setup mode), to remind you to run a post-meal test.If you want to set the alarm, press M.If you do not want to set the alarm, press ▲ or ▼. The will disappear showing an empty fl ashing box. Press M to set.Using the Markers and Test Reminder AlarmCTS-103_CntrLINK_UG_Master_FpB4_v7.indd 30-31CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 30-31 2/7/11 4:00:27 PM2/7/11 4:00:27 PM
Options32 Need Help ? Bayer Diabetes Care: 1-800-348-8100Options33www.bayerdiabetes.com/usWhen the alarm sounds, the meter will auto-matically turn on, the alarm will sound, and the display will show the pre-meal test result you marked when you set the alarm. Pressing any but-ton will silence the alarm.You can now run another test by placing a test strip in the test strip port and following the testing instructions (page 10). When you have completed this test and the result is shown on the display, you may want to mark this test with the symbol to identify this test result as your post-meal result. If you do not want to run another test immediately after the alarm sounds, press any button to turn your meter off.The meter will only set one alarm. It will remember the last alarm set. Any previous alarm setting will be lost.Test Reminder Alarm:To Cancel a Test Reminder Alarm:Press M to enter the meter memory. The 14 day average will appear along with the .Press M again and a box will appear and flash around the .Press ▲ or ▼. The empty box ( ) will now indicate the alarm has been turned off. Press M to set.For example: An alarm has been set. You decide to re-test before that alarm goes off. If you mark the new test result with a pre-meal marker () and set a new alarm(), the old alarm setting will be ignored and only the new setting will sound in 2 hours (or in the time you selected in the Setup mode).Using the Markers and Test Reminder AlarmUsing the Markers and Test Reminder AlarmCTS-103_CntrLINK_UG_Master_FpB4_v7.indd 32-33CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 32-33 2/7/11 4:00:29 PM2/7/11 4:00:29 PM
Options34 Need Help ? Bayer Diabetes Care: 1-800-348-8100Options35www.bayerdiabetes.com/usTO MARK RESULTS YOU WILL SEE TO SET YOU WILL SEE WHAT IT MEANS Pre-MealPress ▲ or ▼(ON)Press M Result is marked as a pre-meal test. You can now set an alarm. AlarmPress ▲ or ▼(ON)Press M Alarm is set to go off after a set amount of time to remind you to run a post-meal test. Post-MealPress ▲ or ▼(ON)Press M Result is marked as a post-meal test. LogbookPress ▲ or ▼(ON)Press M Result is marked in memory as unique. You should note this in your Logbook.Using the Markers and Test Reminder AlarmUsing the Markers and Test Reminder AlarmCTS-103_CntrLINK_UG_Master_FpB4_v7.indd 34-35CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 34-35 2/7/11 4:00:31 PM2/7/11 4:00:31 PM
Options36 Need Help ? Bayer Diabetes Care: 1-800-348-8100Options37www.bayerdiabetes.com/usViewing Stored ResultsUsing the Memory:With the meter off, press the Mbutton on the meter to view stored test results. The 14 day average will appear on the display with the average for test results taken over the last 14 days. If you have set an alarm that has not sounded yet, you will also see a symbol.Number of results: The number of results included in the average is shown at the top of the display. Your control results are not included in this 14 day average. Press ▲ to view the 7 day total. 7 day total: Your meter will display the total number of results taken during the last seven days.High and low results: At the top of the display you will see the number of high results (above 180 mg/dL) and low results (below 72 mg/dL) during that seven day period.Viewing Stored ResultsPress ▼ to review previous results.Previous results: Results will be shown starting with the most recent. Each result will show the date and time the test was taken, as well as any symbols you chose to mark the test result.You can press ▲ or ▼ to scroll forward or backward through the results. You can press and release the button to view stored results one at a time or you can hold it to move through results continuously.When appears on the display, you have viewed all of the results in the memory.The meter will hold 480 results in the memory. When the maximum is reached, the oldest test result will be removed as a new test is completed and saved to the memory.Press M to turn the meter off, or it will automatically turn off after three minutes.CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 36-37CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 36-37 2/7/11 4:00:33 PM2/7/11 4:00:33 PM
Help38 Need Help ? Bayer Diabetes Care: 1-800-348-8100Help39www.bayerdiabetes.com/usError Codes and SymbolsWHAT YOU SEE WHAT IT MEANS WHAT YOU SHOULD DO (will remain on the display)Low batteries.Replace the batteries as soon as possible to avoid the risk of a test result not being stored in your meter. Call Bayer Diabetes Care Customer Service at 1-800-348-8100 for free replacement batteries. (will fl ash for 10 seconds then the meter will turn off)Dead batteries. Replace the batteries immediately to avoid the risk of a test result not being stored in your meter.E 1 Temperature out of range.Move to an area that is within the operating range for the meter (41°F – 113°F). Let the meter adjust to this temperature for twenty minutes before testing.E 2 The test strip has not fi lled with enough blood for an accurate test.Remove the test strip and retest using a new test strip.E 3 The meter is de-tecting a used test strip or blood was applied before the meter was ready.Remove the test strip and retest using a new test strip. Wait until you see the fl ashing blood drop on the display before adding the blood sample.E 4 Test strip is not inserted correctly.Remove and reinsert the test strip properly (see page 11).E 5 E 9E 6 E 12E 8 E 13Potential software or hardware issue.Remove the test strip and retest using a new test strip. If you continue to have problems, contact Bayer Diabetes Care Customer Service.E 7 Wrong test strip. Remove the test strip and retest using a CONTOUR test strip.If you do not resolve the problem, contact Bayer Error Codes and Symbols:Diabetes Care Customer Service at 1-800-348-8100.WHAT YOU SEE WHAT IT MEANS WHAT YOU SHOULD DOE 10 Invalid date or time.See Setup instructions (page 27) to set the date and time on your meter. If you continue to have problems, contact Bayer Diabetes Care Customer Service: 1-800-348-8100.E 11 Abnormal result.Remove the test strip and retest using a new test strip. Carefully follow testing instructions in your User Guide. If you continue to have problems, contact Bayer Diabetes Care Customer Service: 1-800-348-8100.E 15 The meter has detected an error and cannot send the result to your Medtronic device.Turn the Send option off (see page 26), then retest using a new test strip. (You can then manually enter your result into your Medtronic device.)Then contact Bayer Diabetes Care Customer Service. (You can still use your meter for testing, but results cannot be sent to your Medtronic device.)HI Test result is above 600 mg/dL.• Wash your hands and the test site. Repeat the test using a new test strip.• If your result is still “HI,” contact your physician or healthcare professional immediately.WARNING: Glucose levels above 250 mg/dL may indicate a potentially serious medical condition.LO Test result is below 10 mg/dL.• Repeat the test using a new test strip.• If your result is still “LO,” contact your physician or healthcare professional immediately.WARNING: Glucose levels below 50 mg/dL may indicate a potentially serious medical condition.Error Codes and SymbolsCTS-103_CntrLINK_UG_Master_FpB4_v7.indd 38-39CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 38-39 2/7/11 4:00:34 PM2/7/11 4:00:34 PM
Help40 Need Help ? Bayer Diabetes Care: 1-800-348-8100Help41www.bayerdiabetes.com/usSymptoms of High or Low Blood GlucoseError Codes and SymbolsWHAT YOU SEE WHAT IT MEANS WHAT YOU SHOULD DOTest result con-tinues to fl ash for 60 seconds, then stops.The Medtronic device did not acknowledge receipt of the test result within 60 seconds.• Be sure the Medtronic device is located within 4 feet of the CONTOUR LINK meter.• Check that the Medtronic device is set to accept meter results and the meter ID has been programmed into the device.• Check the Medtronic device display to determine if the glucose result has been received by the device. If it has not, you can enter the test result manually.If you continue to have prob-lems, contact Bayer Diabetes Care Customer Service.Control test result is out-of-range (too high or too low).• Test strip or control solution is past the expiration date or is past the discard date.• Test strip is deter-iorated due to heat or exposure to moisture.• Control solution is not at room temp-erature or may not be mixed well.• Incorrect control solution was used.• Check all expiration dates and discard dates. Do not use expired testing materials.• Make sure you are using CONTOUR control solution.• Gently rock the control bottle to ensure the control solution is mixed well.• Run another control test.• If result is still out of range, retest with a new test strip and new control solution.• If result is still out of range, call Bayer Diabetes Care Customer Service.Some display segments do not appear when the meter initially turns on.Possible meter electronics failure.Compare meter display with the illustration on page 4. If the display is not correct, contact Bayer Diabetes Care Customer Service.Results are not displayed in expected units of measure mg/dL. This may affect the way you see your results.Contact Bayer Diabetes Care Customer Service.If you do not resolve the problem, contact Bayer Diabetes Care Customer Service at 1-800-348-8100.Symptoms of High or Low Blood GlucoseYou can better understand your test results by being aware of the symptoms of high or low blood glucose; this will also help you decide what to do if your results seem unusual. Some of the most common symptoms are:*High blood glucose (Hyperglycemia):• frequent urination • excessive thirst • blurred vision • increased fatigue • extreme hunger • irritabilityKetones (Ketoacidosis): • shortness of breath • nausea and vomiting • very dry mouth * For additional information and a complete list of symptoms, contact your healthcare professional or refer to the website for the American Diabetes Association: www.diabetes.orgLow blood glucose (Hypoglycemia):• shakiness• sweating• fast heartbeat• blurred vision• confusion• passing out• seizureCTS-103_CntrLINK_UG_Master_FpB4_v7.indd 40-41CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 40-41 2/7/11 4:00:34 PM2/7/11 4:00:34 PM
Bayer offers the Free Batteries for Life program. When your batteries are low, please call 1-800-348-8100 for your free batteries.Extras42 Need Help ? Bayer Diabetes Care: 1-800-348-8100Extras43www.bayerdiabetes.com/usChanging the Batteries:Batteries should be replaced when the meter continually displays or the meter briefly shows and then turns off (See Error Codes and Symbols, page 38).Turn off your meter before chang-ing your batteries.Press firmly on the battery cover and slide in the direction of the arrow.NOTE: If you put the new batteries in the meter within 5 minutes of taking the old ones out, all your settings and results will be saved. If you take more than 5 minutes, you will need to reset the date and time although your other settings and results will be saved.Remove the old batteries by pressing the top of the battery which will raise the bottom of the battery up.Place new batteries under the prongs and into the battery compartment with the “+” side up. (Battery part numbers are DL2032 or CR2032.)Caring for the SystemWARNING: When a low battery warning displays on the meter, replace the battery as soon as possible to avoid a test result not being stored in the meter memory.Changing the BatteriesCaring for the System:• When a low battery warning displays on the meter, replace the battery as soon as possible to avoid a test result not being stored in the meter memory.• Store the meter in the carrying case provided whenever possible.• Wash your hands and dry thoroughly before handling to keep the meter and test strips free of oils and other contaminants.• Handle the meter carefully to avoid damaging the elec-tronics or causing other malfunctions.• Avoid exposing the meter and test strips to excessive humidity, heat, cold, dust, or dirt.Please see page 18 for details on cleaning and disinfecting your meter.Slide the battery cover back into place, lining up with the open slots, and close fi rmly. WARNING: Keep batteries away from children. Lithium batteries are poisonous. If swallowed, immediately contact your physician or poison control center. Discard batteries according to your local environmental regulations.CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 42-43CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 42-43 2/7/11 4:00:34 PM2/7/11 4:00:34 PM
For complete instructions on disinfecting and cleaning your meter and lancing device, please see page 18.WARNING: Do not allow solution to run down into the test strip port or around the buttons. Doing so may cause a malfunction.Extras44 Need Help ? Bayer Diabetes Care: 1-800-348-8100Extras45www.bayerdiabetes.com/usTransferring Results to a ComputerTechnical InformationTransferring Results to a Computer:You can easily transfer test results from the CONTOUR LINK meter to a computer that includes the Bayer's GLUCOFACTS® DELUXE Diabetes Management Software or Medtronic CareLink® Therapy Management Software. The results can then be summarized into easy-to-read reports that you can share with your physician. A Bayer data cable is required to use this feature.For more information, call our Bayer Diabetes Care Customer Service (1-800-348-8100), or visit our website at www.bayerdiabetes.com/us.For CareLink information, visit www.medtronicdiabetes.com.NOTE: If the cable is connected to the data port (even if the cable is not connected to a PC), results will NOT be sent to the Medtronic device.IMPORTANT: The CONTOUR LINK meter has not been tested or certifi ed by Bayer for use with any software other than Bayer's GLUCOFACTS® DELUXE diabetes management software or CareLink Software. Bayer is not responsible for any erroneous results from the use of other software.AccuracyDiabetes experts have suggested that glucose meters should agree within 15 mg/dL of a laboratory method when the glucose concentration is lower than 75 mg/dL, and within 20% of a laboratory method when the glucose concentration is 75 mg/dL or higher. The chart below displays how often the CONTOUR LINK meter achieves this goal. The chart is based on a study done on 100 patients to see how well the CONTOUR LINK compared to laboratory results.For glucose results lower than 75 mg/dL, the percent (and number) of meter results that match the laboratory method within 15 mg/dL :98.7% (75/76)For glucose results at 75 mg/dL or higher, the percent (and number) of meter results that match the laboratory method within 20%: 98.5%(319/324)Note: When meter results are compared to the laboratory results, results below 75 mg/dL are compared in mg/dL. PrecisionA study was conducted with the CONTOUR LINK blood glucose monitoring system with fi ve heparinized whole blood specimens with glucose levels from 44 to 332 mg/dL. Multiple replicates (n=100) were tested using multiple CONTOUR LINK blood glucose meters and one lot of CONTOUR blood glucose test strips. The following precision results were obtained:Plasma/SerumMean SD Coeffi cient of variation 41.8 mg/dL 1.26 mg/dL 3.02% 78.1 mg/dL 1.99 mg/dL 2.55% 125.7mg/dL 2.67 mg/dL 2.12% 198.0 mg/dL 4.32 mg/dL 2.18% 312.3 mg/dL 5.01 mg/dL 1.60%Technical Information:CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 44-45CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 44-45 2/7/11 4:00:44 PM2/7/11 4:00:44 PM
Extras46 Need Help ? Bayer Diabetes Care: 1-800-348-8100Extras47www.bayerdiabetes.com/usSpecifi cationsSpecifi cationsSpecifi cations:Test Sample: Whole bloodTest Result : Referenced to plasma/serum glucoseSample Volume: 0.6 µLMeasuring Range: 20- 600 mg/dL Measuring Time: 5 secondsMemory Feature: Stores most recent 480 test resultsRadio Frequency: 916.5 MHzBattery Type: Two 3-volt lithium batteries (DL2032 or CR2032)Battery Life: Send option off: About 1000 tests (1 yr. average use). Send option on: About 244 tests (2 months at 4 transmitted results per day). Operating Temperature Range: 41°F–113°FHumidity: 10 –93% RHDimensions: 77 mm (H) x 57 mm (W) x 23 mm (T)Weight: 1.85 ouncesAlarm: “Beeps” whenever a test strip is inserted into or removed from the meter, when the test strip is fi lled with blood or control solution, and when a test result appears in the display. Two beeps will sound for an error. Twenty beeps will sound when a pro-grammed alarm goes off. CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 46-47CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 46-47 2/7/11 4:00:45 PM2/7/11 4:00:45 PM
Extras48 Need Help ? Bayer Diabetes Care: 1-800-348-8100Extras49www.bayerdiabetes.com/usWarrantyWarrantyother than CONTOUR test strips or when the CONTOUR test strip is altered or modifi ed in any manner.5. Bayer HealthCare makes no warranty of the performance of the CONTOUR® LINK meter or test results when used with any control solution other than CONTOUR control solution.BAYER HEALTHCARE MAKES NO OTHER EXPRESS WARRANTY FOR THIS PRODUCT. THE OPTION OF REPLACEMENT, DESCRIBED ABOVE, IS BAYER HEALTHCARE’S ONLY OBLIGATION UNDER THIS WARRANTY. IN NO EVENT SHALL BAYER BE LIABLE FOR INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, EVEN IF BAYER HEALTHCARE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.Some states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you. This warranty gives you specifi c legal rights and you may also have other rights which vary from state to state.For warranty service: Purchaser must contact the Customer Service Department of Bayer Diabetes Care, by calling toll free 1-800-348-8100, for assistance and/or instructions for obtaining service of this instrument.Warranty:Manufacturer’s Warranty: Bayer HealthCare warrants to the original purchaser that this instrument will be free from defects in materials and workmanship for 5 years from the date of original purchase (except as noted below). Dur-ing the stated 5-year period, Bayer HealthCare shall, at no charge, replace a unit found to be defective with an equiva-lent or current version of the owner’s model.Limitations of Warranty: This warranty is subject to the following exceptions and limitations:1. A 90-day warranty only will be extended for consumable parts and/or accessories.2. This warranty is limited to replacement due to defects in parts or workmanship. Bayer HealthCare shall not be required to replace any units which malfunction or are damaged due to abuse, accidents, alteration, misuse, neglect, maintenance by someone other than Bayer HealthCare, or failure to operate the instrument in accordance with instructions. Further, Bayer HealthCare assumes no liability for malfunction or damage to Bayer HealthCare instruments caused by the use of reagents other than reagents (i.e., CONTOUR® test strips) manufactured or recommended by Bayer HealthCare.3. Bayer HealthCare reserves the right to make changes in design of this instrument without obligation to incorporate such changes into previously manufactured instruments.4. Bayer HealthCare has no knowledge of the performance of the CONTOUR LINK blood glucose meter when used with any test strips other than CONTOUR test strips, and therefore makes no warranty of the performance of the CONTOUR LINK meter when used with any test strips CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 48-49CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 48-49 2/7/11 4:00:45 PM2/7/11 4:00:45 PM
Extras50 Need Help ? Bayer Diabetes Care: 1-800-348-8100Extras51www.bayerdiabetes.com/usService and SuppliesService and SuppliesSupplies:When calling or writing for supplies, be sure to include the number with the name of the replacement part or accessory item.Replacement PartsPart Number* Item40030030 3-volt Lithium Battery (DL2032 or CR2032) — 2 (Free Batteries for Life program. Call 1-800-348-8100.)CTS-103 CONTOUR® LINK User Guide40453291 Bayer’s USB Data Cable * Part numbers are subject to change without noticeREFERENCES1 FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication" (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm2 CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens" (2010)http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html3 American Diabetes Association. Standards of Medical Care in Diabetes - 2011. Diabetes Care 2011; 34 (1):S11-S61. Service Information:If you have a problem and none of the problem-solving steps in the User Guide help, call a Bayer HealthCare Representative. We have trained specialists to help you.Important: Speak to a Bayer HealthCare Representative before returning your meter for any reason. He/she will give you the information needed to get your problem handled correctly and effi ciently. Have your CONTOUR LINK blood glucose meter and CONTOUR test strips available when you phone. It would also be helpful to have a bottle of CONTOUR control solution nearby.CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 50-51CTS-103_CntrLINK_UG_Master_FpB4_v7.indd 50-51 2/7/11 4:00:45 PM2/7/11 4:00:45 PM
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Bayer HealthCare LLCMishawaka, IN 46544 USAwww.bayerdiabetes.com/usBayer, the Bayer Cross, CONTOUR, MICROLET, Clinilog, GLUCOFACTS and the No Coding logo are registered trademarks of Bayer. No Coding is a trademark of Bayer. Paradigm, Guardian, CareLink and Bolus Wizard are registered trademarks of Medtronic MiniMed, Inc.CTS-103 © 2010 Bayer. All rights reserved. Rev. 11/10CTS-103_CntrLINK_UG_Master_FpB4_v7.indd obc54CTS-103_CntrLINK_UG_Master_FpB4_v7.indd obc54 2/7/11 4:00:45 PM2/7/11 4:00:45 PM

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