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Arkon FREESTYLE NAVIGATOR PRT03831-xxx User Manual

Arkon blood glucose meter user manual
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Customer Care available 24 hours a day,
7 days a week at: 1-866-597-5520
User's Guide
www.continuousmonitor.com
This product and its use are protected under U.S. Patent Numbers:
5,262,035; 5,264,104; 5,264,105; 5,593,852; 5,899,855; 5,918,603; 5,965,380; 6,071,391; 6,103,033;
6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,162,611; 6,175,752; 6,284,478; 6,299,757; 6,329,161;
6,338,790; 6,461,496; 6,484,046; 6,503,381; 6,514,718; 6,560,471; 6,565,509; 6,591,125; 6,592,745;
6,605,200; 6,605,201; 6,616,819; 6,618,934; 6,676,816; 6,749,740; 6,893,545; 6,932,894; 6,942,518;
6,973,706; 6,990,366; 7,003,340; 7,003,341; 7,074,308; 7,090,756; 7,299,082.
Abbott Diabetes Care Inc., 1360 South Loop Road, Alameda, CA 94502 ©2008 Abbott
CAUTION:
Federal law restricts this device to sale by or on the order of a physician.
ART16072 Rev. A 05/08

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  • Page 1 Customer Care available 24 hours a day, 7 days a week at: 1-866-597-5520 User’s Guide www.continuousmonitor.com This product and its use are protected under U.S. Patent Numbers: 5,262,035; 5,264,104; 5,264,105; 5,593,852; 5,899,855; 5,918,603; 5,965,380; 6,071,391; 6,103,033; 6,120,676; 6,121,009; 6,134,461; 6,143,164; 6,162,611; 6,175,752; 6,284,478; 6,299,757; 6,329,161; 6,338,790;...

  • Page 3: Indications For Use

    FreeStyle Navigator® Continuous Glucose Monitoring System, traditional blood glucose tests must be performed. The FreeStyle Navigator® Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result.

  • Page 5: How To Use This Guide

    How to Use this Guide? This guide has many Sections arranged in a logical sequence that will be useful for the first time use and every use thereafter. Most Sections begin with a purpose for that Section, when to perform the steps in that Section, materials required to perform the steps in that Section and important cautions, warnings and helpful information.

  • Page 6: Table Of Contents

    Table of Contents Section 1: n  Getting Acquainted........... . 1 – 12 Parts of the System.
  • Page 7 Section 10: n  Respond to Alarms, Errors, and Problems ......89 – 108 Alarm Messages: What are they, What do they mean, and What you should do.

  • Page 9: Getting Acquainted

    1 Getting Acquainted...
  • Page 10 Section 1 – Key Terms Alarms Blood Glucose Mode   Continuous Monitoring Mode   FreeStyle Navigator Continuous Glucose   Monitoring System FreeStyle Test Strips   in vitro Interstitial Fluid LeFT/RIGhT Option Buttons Receiver Receiver Display Screen Receiver Test Strip Port Reports Sensor Sensor Delivery Unit...
  • Page 11 Memory to hold up to 60 days worth of data. • Wireless communication capabilities to a personal computer. • Built-in FreeStyle® Blood Glucose Meter for performing blood glucose measurements. • Event entry capabilities (like meals, exercise, insulin and other). •...
  • Page 12 Section 1 Getting Acquainted How are the parts packaged? Your FreeStyle Navigator system comes with two kits: • A System kit. • A Sensor kit. The System Kit 1 FreeStyle Navigator Receiver in a Receiver Skin • 2 AAA Alkaline Batteries (for the receiver) •...
  • Page 13 Note: The receiver also has a built-in FreeStyle Blood Glucose Meter that can be used for blood glucose testing. The receiver should always be kept with you on a belt, in a pocket, or in a purse.
  • Page 14 Section 1 Getting Acquainted Key features of the System Your receiver comes with backlight capability to see the screen in dark environments. The backlight can be turned on by pressing and releasing the DOWN Arrow button and then pressing and releasing the RIGHT Option button.
  • Page 15 Using your system For Daily Activities You will be wearing a sensor and a transmitter at all times while you are using the system. Keep the following in mind as you go about your normal routine. • Only wear the sensor and transmitter on a flat surface of either your abdomen or the back of your upper arm.
  • Page 16 Section 1 Getting Acquainted How do I prepare my system for the first time? When you are setting up your receiver for the first time, perform all of the procedures listed below in the order that they are listed. Check each procedure off when you complete it. Install batteries in the transmitter first and then in the receiver (see Section 2).

  • Page 17: Warnings, Cautions And Important Notes

    Warnings, Cautions And Important Notes Important Notes About System Performance The following items describe situations that could lead to inaccurate or unreliable continuous glucose results. Cautions: • Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and cause the sensor to dislodge.
  • Page 18 Section 1 Getting Acquainted Important Things to Remember About System Calibration Important: In clinical trials, we observed that the sensor signal sometimes temporarily decreases from the true value. This typically happens at night during sleep, and recovers rapidly when the user moves or is awakened.
  • Page 19 Before You Get Started Cautions: • Low or high glucose measurements can indicate a potentially serious medical condition. • If you have hypoglycemia, or hypoglycemia unawareness, then test ONLY on your fingers. • The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia.
  • Page 20 Section 1 Getting Acquainted Before You Get Started • If your results from the continuous monitoring mode do not reflect how you feel, test your glucose using the Blood Glucose mode. • If you observe a significant change in your continuous glucose readings that you think is erroneous, or if you feel the blood glucose measurement in the Blood Glucose mode is erroneous and you are close to an electromagnetic interference source, move away from the source of interference and check to see if the condition fades away.

  • Page 21: Hypoglycemia Unawareness

    What is Hypoglycemia Unawareness? Hypoglycemia unawareness is a condition where you are having hypoglycemia but you do not have any of the usual warning symptoms (such as rapid heartbeat, sweating, shakiness, anxiety, or a tingling sensation in your fingers or toes). Those warning symptoms are either absent or greatly reduced. Instead, the first sign may be confusion or impaired thinking, which makes it even more difficult to know if you are experiencing low blood glucose.

  • Page 22: Blood Glucose Mode (Bg))

    • “Glucose BG ” at the top left of the display. – Built-in FreeStyle Blood Glucose Meter. • Measures glucose from a blood sample that you supply. • Uses a FreeStyle Test Strip to measure blood glucose levels.

  • Page 23: Install Or Replace Transmitter And Receiver Batteries

    2 Install or Replace Transmitter and Receiver Batteries...
  • Page 24 Section 2 – Key Terms Alarm Icon Receiver Transmitter Battery Life Alkaline Batteries 357 hC Silver Oxide Battery Reconnect Customer Care: 1-866-597-5520...
  • Page 25 2 Install or Replace Transmitter and Receiver Batteries Purpose To ensure that your FreeStyle Navigator system has power to operate properly. Start Do this procedure: • The first time you use your FreeStyle Navigator system. • When the receiver displays the Low Battery message and alarm and the battery icon • When the receiver sounds an alarm and displays the “Replace TX Battery with Next Sensor” message. Materials Gather these materials before you begin: • 2 new AAA alkaline batteries for the receiver. We recommend Energizer® Max®, Energizer®...
  • Page 26 Section 2 Install or Replace Transmitter and Receiver Batteries Install or Replace the Transmitter Battery Install or Replace the Receiver Batteries Battery door Turn the circular battery door counterclockwise with either a coin or your fingernail. (Fig. 1) Carefully remove the battery door. Remove the old battery, if any, and discard it properly.
  • Page 27 Match what you see on your Receiver with ONE of the screen shots shown below. If the display is Glucose CM 08:30A Main Set Date/Time 08:30A 08 : 30 A 05 - 10 - 2005 Next Select Mode 08:30A Continuous Mode CM Blood Glucose BG Install or Replace Transmitter and Receiver Batteries Then...
  • Page 28 Section 2 Install or Replace Transmitter and Receiver Batteries Reconnect the Receiver to the Transmitter. System Menu 08:30A Reconnect Data Upload Status Link Set Date/Time Main Select Check your work. Place the receiver within 10 feet of the transmitter. Press the RIGHT Option button twice to display the Main Menu screen.

  • Page 29: Set The Time And Date

    3 Set the Time and Date...
  • Page 30 Section 3 – Key Terms LeFT/RIGhT Option Buttons   Main Menu   Receiver   System Menu   Transmitter UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 31 3 Set the Time and Date Purpose To ensure the correct time and date are associated with your data. Start Do this procedure: • The first time you use your FreeStyle Navigator system. • When you install new batteries. Materials Your FreeStyle Navigator Receiver. Helpful Information Important: Be sure to set the date and time correctly. The correctness of the line graph and statistical reports depends upon the date and the time being correct.
  • Page 32 Section 3 Set the Time and Date Steps Go to the System screen. Main 08:30A Glucose Alarms Reports System Add Event Select Select Set Date/Time from the System Menu screen. System Menu 08:30A Reconnect Data Upload Status Link Set Date/Time Main Select Set the time.
  • Page 33 Steps Set the date. Check your work. Do This a. Press the LEFT Option button (Next) to move to the Month field. b. Use the UP/DOWN Arrow buttons to set the current month. c. Press the LEFT Option button (Next) to move to the Date field.
  • Page 34 Customer Care: 1-866-597-5520...

  • Page 35: Perform A Control Solution Test

    4 Perform a Control Solution Test...
  • Page 36 Section 4 – Key Terms Control Solution Test FreeStyle Control Solution   FreeStyle Test Strips   LeFT/RIGhT Option Buttons   Receiver   UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 37 4 Perform a Control Solution Test Purpose The purpose of the control solution test is to: • Ensure that your receiver and test strips are working properly prior to calibration or blood glucose testing. • Check that you are following the correct testing procedure. • Practice Blood Glucose mode testing without having to use your own blood.
  • Page 38 Section 4 Perform a Control Solution Test Steps Verify that your FreeStyle Control Solution is current. Prepare test strip. Do This Note: FreeStyle Control Solution is good for three months after opening the bottle, or until the expiration date printed on the label, whichever comes first.
  • Page 39 Steps Insert test strip into the receiver. Compare code numbers. • The numbers match. • The numbers do NOT match. • The screen changes to the Apply Sample screen. Strip Code 08:30A Cancel Do This a. Turn the test strip so “FreeStyle” text faces up. b. Grasp the test strip by the end with the two half circles. c.

  • Page 40: Control Solution

    Section 4 Perform a Control Solution Test Steps Apply control solution. Confirm that you used a control solution. Do This Important: Do NOT apply control solution to both edges of the test strip. Notes: • Gently touch ONLY ONE EDGE of the test strip to the control solution next to one of the dark half-circles.
  • Page 41 Steps Evaluate the test results. If the result • Falls WITHIN the range. • Falls OUTSIDE of the range. • Is an error message. Glucose BG 08:30A mg/dL Control Solution? Check your work. Perform a Control Solution Test Do This Compare the test results displayed on the screen to the range printed on the vial of test strips.
  • Page 42 Customer Care: 1-866-597-5520...

  • Page 43: Insert Or Remove Your Sensor

    5 Insert or Remove Your Sensor...
  • Page 44 Section 5 – Key Terms Calibration Sensor Inserter Reconnect Sensor Insertion Button Sensor Sensor Insertion Site Sensor Delivery Unit Sensor Locking Pin Now that you are ready to insert a sensor, here are a few helpful tips. • onnect your transmitter and receiver BEFORE inserting a new sensor. •...
  • Page 45 5 Insert or Remove Your Sensor Purpose To insert, remove, or replace a small, thin, plastic sensor under your skin so that your FreeStyle Navigator system can continuously monitor your glucose level. Start Do this procedure: • The first time you use your FreeStyle Navigator system. • Every 5 days after that.

  • Page 46: Insert Your Sensor

    Section 5 Insert or Remove Your Sensor Important Things to Know About Getting Reliable Results Caution: Movement of the sensor support mount or excessive perspiration at the sensor insertion site due to activities like vigorous exercise or bumping against objects may lead to poor adhesion of the support mount to the skin and then cause the sensor to dislodge.
  • Page 47 Steps Remove the sensor. Fig. 1 Fig. 2 Insert or Remove Your Sensor Do This a. Wipe a small amount of isopropyl alcohol around the edges of the sensor support mount. Note: You can use a regular alcohol prep pad from your local drugstore.

  • Page 48: The Transmitter

    Section 5 Insert or Remove Your Sensor Steps End sensor session. 08:30A Did You Remove The Sensor? Reconnect the receiver to the transmitter. System Menu 08:30A Reconnect Data Upload Status Link Set Date/Time Main Select Select an insertion site. Abdomen Back of upper arm Do This a.

  • Page 49: Prepare The Insertion Site

    Steps Prepare the insertion site. Remove the sensor delivery unit from package. Remove the protective liner from the sensor support mount. Insert or Remove Your Sensor Do This a. Wash your hands thoroughly with soap and water. b. Clean the selected insertion site area with soap and water.
  • Page 50 Section 5 Insert or Remove Your Sensor Steps Attach the sensor delivery unit to your skin. Top of the Sensor Support Mount • Inserting the sensor on the back of your arm. • Inserting the sensor on your abdomen. Ensure that the adhesive pad is adhered to your skin. Do This a.
  • Page 51 Steps Remove the locking pin. Insert sensor. Remove inserter Insert or Remove Your Sensor Do This a. Grasp the top of the locking pin with your thumb and index finger. b. Twist the locking pin a 1/4 turn in either direction until the locking pin clicks.
  • Page 52 Section 5 Insert or Remove Your Sensor Steps Check the sensor support mount. Do This a. Confirm the sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion.
  • Page 53 Steps Discard the sensor inserter safely. Check your work. Insert or Remove Your Sensor Do This We recommend a sharps container or a puncture-proof container with a tight lid. Result: An inserted sensor, a removed sensor, or a replaced sensor. You have done this procedure correctly when: o ...
  • Page 54 Customer Care: 1-866-597-5520...

  • Page 55: Attach Your Transmitter

    6 Attach Your Transmitter...

  • Page 56: Sensor Code

    Section 6 – Key Terms LeFT/RIGhT Option Buttons Receiver   Sensor Code Sensor Support Mount System Transmitter UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 57 6 Attach Your Transmitter Purpose To enable the transmitter to send glucose data to the receiver. Start Do this procedure after inserting a new sensor. Materials Your FreeStyle Navigator Transmitter with battery installed. Helpful Information Important: Do NOT remove or replace the transmitter from the sensor support mount while wearing a sensor.
  • Page 58 Section 6 Attach Your Transmitter Steps Attach the transmitter to the sensor support mount. Fig. 1 Fig. 2 Confirm the transmitter is correctly attached to the sensor support mount. • No • Yes Do This a. Position the transmitter over the sensor support mount so that the battery side faces the mount.
  • Page 59 Steps Apply an over-bandage (Optional). Caution: If your results from the Continuous Monitoring mode seem erroneous, check and make sure that the sensor has not dislodged. If you notice the sensor is dislodged from the skin, or if you see that the adhesive on your overbandage or the sensor support mount is coming loose, discard the old sensor and insert a new sensor.
  • Page 60 Section 6 Attach Your Transmitter Steps Check your work. Do This Result: A transmitter ready to send glucose data. You have done this procedure correctly when: The transmitter is securely attached to the sensor support mount. You have applied an over-bandage as necessary to hold down the transmitter and the sensor support mount.

  • Page 61: Calibrate Your System/Test Blood Glucose Manually

    7 Calibrate Your System/Test Blood Glucose Manually...
  • Page 62 Section 7 – Key Terms BG Mode Calibrate Calibration BG Control Solution FreeStyle Test Strips Icon Lancet Lancing Device Lancing Device Cocking handle Lancing Device Depth Indicator window Lancing Device Depth Setting Lancing Device Lancet Cup holder LeFT/RIGhT Option Buttons Receiver Test Strip Port Sharps Container UP/DOwN Arrow Buttons...
  • Page 63 (performed in the Blood Glucose mode using the built-in FreeStyle Blood Glucose Meter). In order to calibrate, the receiver compares the reading it gets from the blood to the reading the sensor takes from the interstitial fluid.
  • Page 64 Section 7 Calibrate Your System/Test Blood Glucose Manually Helpful Information (con’t) • MUST successfully complete 4 calibration tests. You will calibrate at approximately 10, 12, 24 and 72 hours after sensor insertion. If you do not complete calibration tests successfully in the allotted time periods, your glucose readings will NOT be displayed and alarms will be inactive.
  • Page 65 Helpful Information (con’t) Some common reasons for unsuccessful calibrations • Your BG test result is below 60 mg/dL (3.3 mmol/L) or above 300 mg/dL (16.7 mmol/L). Perform the calibration test when your blood glucose is within the above range. • Your blood glucose is changing too rapidly.
  • Page 66 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Insert a FreeStyle Test Strip into the receiver’s test strip port. Ensure that the code number on the screen matches the code number on the test strip vial. • The numbers match. a. Press the RIGHT Option button (Set). • The numbers do NOT match.
  • Page 67 Steps Select a test site. • You are calibrating the system. • You are simply doing a manual glucose test and NOT calibrating. Calibrate Your System/Test Blood Glucose Manually Do This Caution: If you have hypoglycemia, or hypoglycemia unawareness, then test ONLY on your fingers. Note 1: Vary the sites from test to test to avoid tenderness and to avoid creating calluses.
  • Page 68 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Prepare for lancing. If your test site is • A finger. • Your forearm or a test site other than the finger. Do This a. Wash your hands and the selected test site with soap and water.
  • Page 69 Steps Prepare for lancing. (con’t) If you are lancing • A finger. • Your forearm. If you are using • A finger. • Your forearm. Calibrate Your System/Test Blood Glucose Manually Do This g. Select the lancing device depth setting. Then Set the depth setting to its shallowest depth (1). Start at Level (2) or higher if your experience with setting 2 does not produce a usable sample.
  • Page 70 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Lance the site. Do This To lance your finger (grey cap): a. Lightly touch the lancing device against the side of your fingertip. b. Press the release button. c. Put the lancing device down. d.
  • Page 71 Steps Test the sample. Proccessing 08:30A Cancel • The stopwatch icon does NOT appear within 5 seconds. • The receiver BEEPS ONCE (only if Progress Tones are turned on). • The stopwatch icon appears. • The receiver BEEPS TWICE (only if Progress Tones are turned on). • Your blood glucose results appear in the display (takes an average of 7 seconds).
  • Page 72 Section 7 Calibrate Your System/Test Blood Glucose Manually Steps Interpret the blood glucose results. • Lo appears in the display. Lo appears when the measured glucose result is less than 20 mg/dL (1.1 mmol/L). • Hi appears in the display. Hi appears when the measured glucose result is more than 500 mg/dL...
  • Page 73 Steps Remove and discard the test strip Discard the lancet. Check your work. Calibrate Your System/Test Blood Glucose Manually Do This Important: Test strips may be used only once. Discard used test strips. Note: Use a sealed container such as a sharps container to avoid biohazards.
  • Page 74 Customer Care: 1-866-597-5520...

  • Page 75: Set, Review, Or Change The Alarm Settings

    8 Set, Review, or Change the Alarm Settings...
  • Page 76 Section 8 – Key Terms Alarm Menu Alarm Sensitivity Alarm Type Data Loss high Glucose Alarm high Glucose Threshold LeFT/RIGhT Option Buttons Low Glucose Alarm Low Glucose Threshold Main Menu Progress Tones Projected high Alarm Projected Low Alarm Receiver System System Alarms UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 77 8 Set, Review, or Change the Alarm Settings Purpose To set the receiver to: • Alert you when your glucose conditions change. • Notify you when the receiver needs attention. • Notify you when the receiver begins or completes certain activities. Start Do this task: • Immediately after you finish the first set up of your FreeStyle Navigator system. • When your healthcare team gives you new glucose threshold numbers. • Anytime you get a “Preferences Lost Reconfigure” alarm message on the receiver. • Anytime you replace your receiver. • Anytime you want to change your alarm settings. • Anytime you want to review your alarm settings. Materials • Your FreeStyle Navigator Receiver. • Low and high glucose threshold values (from your healthcare team). Helpful Information Caution: The high and low alarms are intended to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia.

  • Page 78: About Glucose Alarms

    Section 8 Set, Review, or Change the Alarm Settings About Glucose Alarms The FreeStyle Navigator® system is designed to alert you when your glucose levels reach preset low or high values. These values or ‘threshold values’ can be programmed in the receiver for any individual.
  • Page 79 About Glucose Alarms (con’t) Follow the guidelines below when selecting your alarm settings for detection of high and low glucose conditions. When the detection rate is maximum, you will get the greatest number of alarms. When the detection rate is minimum, you will get the fewest number of alarms. Threshold Alarm Caution: Do NOT rely solely on the projected glucose alarms for detection of low or high glucose conditions.
  • Page 80 Section 8 Set, Review, or Change the Alarm Settings Steps Access the Alarms menu from the Main menu. Main 08:30A Glucose Alarms Reports System Add Event Select Decide what to do. • Set, review or change the Low glucose alarm. • Set, review or change the High glucose alarm. • Set, review or change the PROJECTED Low glucose alarm. • Set, review or change the PROJECTED High glucose alarm. • Set, review or change the Data loss alarms. • Set, review or change the System alarms.

  • Page 81: Mute Alarms

    Steps Set, review, or change the Low Glucose alarm. Alarm Settings 08:30A Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Main Select Decide what settings you want: • Alarm on or off. • Your threshold value. Note: The alarm can only be set between 60 and 139 mg/dL (3.3 mmol/L and 7.7 mmol/L).
  • Page 82 Section 8 Set, Review, or Change the Alarm Settings Steps Set, review, or change the High Glucose alarm. Alarm Settings 08:30A Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Main Select Decide what settings you want: • Alarm on or off.
  • Page 83 Steps Set, review, or change your Projected Low glucose alarm. Alarm Settings 08:30A Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Data Loss Main Select Decide what settings you want: • Alarm on or off. • Sensitivity. • Alarm type (Setting). –...
  • Page 84 Section 8 Set, Review, or Change the Alarm Settings Steps Set, review, or change your Projected High glucose alarm. Alarm Settings 08:30A Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Data Loss Main Select Decide what settings you want: • Alarm on or off.
  • Page 85 Steps Set, review, or change the Data Loss alarms. Alarm Settings 08:30A Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Data Loss Main Select Decide what settings you want: • Alarm on or off. • Alarm type (Setting). – Low, medium, or high beep. –...
  • Page 86 Section 8 Set, Review, or Change the Alarm Settings Steps Set System Alarms. Alarm Settings 08:30A High Glucose (275) Projected Low (On) Projected High (O ) Data Loss System Alarms Main Select Decide what settings you want: • Alarm on or off. • Alarm type (Setting). –...
  • Page 87 Steps Set Progress Tones. Alarm Settings 08:30A Projected Low (On) Projected High (O ) Data Loss System Alarms Progress Tones Main Select Decide what settings you want: • Turn progress tones on or off. • Set progress tones volume low or high. • You want to mute alarms. • You are finished setting, reviewing, and changing alarms. Set, Review, or Change the Alarm Settings Do This a.
  • Page 88 Section 8 Set, Review, or Change the Alarm Settings Steps Mute all audible alarms for 1 hour. Alarm Settings Mute Alarms Low Glucose (70) High Glucose (275) Projected Low (On) Projected High (O ) Main Select Alarm Settings Mute Alarms For One Hour? Cancel Select...

  • Page 89: Daily Use

    9 Daily Use...
  • Page 90 Section 9 – Key Terms BG Mode CM Mode Directional Glucose Trend Arrows Icon Receiver Transmitter Transmitter Receiver Connection Customer Care: 1-866-597-5520...
  • Page 91 9 Daily Use Purpose To read and understand your display screen. Start Do this procedure: • Anytime you are using your system in the Continuous Monitoring mode. Materials Your receiver. Helpful Information • Your receiver and transmitter must be linked, connected, and calibrated in order to use the system in the Continuous Monitoring mode. • When you sleep, place the receiver on a high headboard or on a nearby dresser rather than clipping it to your bed clothing or taking it to bed. Be aware that if the receiver is set to vibrate and if you place it too far from you, you may not hear it vibrate.
  • Page 92 Section 9 Daily Use Steps Decide what to do. • Connect your receiver and transmitter. • Reconnect your receiver and transmitter. • Interpret the CM screen. • Interpret icons on the CM screen. • Interpret icons on the Main screen. • Turn the receiver backlight on. Reconnect the receiver to the transmitter. If the receiver has lost connection • For less than 30 minutes. • For 30 minutes or more. System Menu Reconnect Data Upload Status Link...
  • Page 93 Steps Interpret the CM screen. Location Glucose Glucose CM Glucose CM Glucose CM Glucose CM Caution: Before adjusting treatment for diabetes management based on the continuous glucose results from your FreeStyle Navigator system, perform a Blood Glucose mode test to confirm the continuous result. Do This Press the RIGHT Option button to turn the display on.
  • Page 94 Section 9 Daily Use Steps Interpret the icons. This Icon Do This Note: The directional trend arrows are different from the projected glucose alarms (Section 8). For example, you can have a projected low glucose alarm and still have a relatively stable trend arrow.
  • Page 95 Steps Turn the Backlight on. Press First Press Second Check your work. Do This a. In order to turn the backlight on, your receiver has to be turned off. If the receiver is on, wait for 12 seconds to allow the receiver to turn off. b.
  • Page 96 Customer Care: 1-866-597-5520...

  • Page 97: Respond To Alarms, Errors, And Problems

    10 Respond to Alarms, Errors, and Problems...
  • Page 98 Section 10 – Key Terms Alarms Menu Calibration BG CM Status Calibration   high Glucose Alarm Icon Low Glucose Alarm Projected high Alarm Projected Low Alarm Receiver Status Sensor Sensor Support Mount Status Information Transmitter Transmitter Receiver Connection Transmitter Status Customer Care: 1-866-597-5520...
  • Page 99 10 Respond to Alarms, Errors, and Problems Purpose To resolve alarm messages, error codes, or problems. Start Do this any time you: • Receive either an alarm or an error code in the Continuous Monitoring mode or the Blood Glucose mode. • Experience problems with your FreeStyle Navigator system. Materials Your FreeStyle Navigator system. Helpful Information Caution: For ALL alarms, if you do not turn on the display of the receiver within the first hour of the notification of an alarm, the receiver will stop beeping (or vibrating).
  • Page 100 Section 10 Respond to Alarms, Errors, and Problems Status Information The receiver can provide you with a number of different types of Status Information. Available Status Information is listed in the following table. To access the Status information, press the RIGHT option button twice to get to the Main menu and use the UP or DOWN arrow button to highlight System.
  • Page 101 Status Information (con’t) Status Information CM Status. CM Status 08:30A Last Reset: OK Can’t Cal: Cal Failed: BG High Sensor Err: 207 Back Main Calibration BG. 08:30A Do You Want To Calibrate? Alarms and Errors Display Glucose CM 03:00A mg/dL Projected Low Glucose Acknowledge...
  • Page 102 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 103 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 104 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 105 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 106 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 107 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 108 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 109 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 110 Section 10 Respond to Alarms, Errors, and Problems...
  • Page 111 Troubleshoot problems The problems you can troubleshoot in this Section are listed below and are arranged in the order of appearance. Receiver • The receiver will not turn on. • The blood glucose test won’t start after you apply a sample. •...
  • Page 112 Section 10 Respond to Alarms, Errors, and Problems The receiver will not turn on. The Blood Glucose test won’t start after you apply a sample. a. Was the test strip inserted correctly (the “FreeStyle” side was up as you inserted the end with the dark rectangle)? If YES, go to Step c.
  • Page 113 Unexpected characters on the receiver display screen, unusual or unexpected receiver screen appearance. The batteries are installed correctly. The batteries are installed incorrectly. Respond to Alarms, Errors, and Problems If you are close to a source of electromagnetic interference (see Appendix C for further details), move away from the interfering source and see if the problem goes away.
  • Page 114 Section 10 Respond to Alarms, Errors, and Problems There is no glucose value on the screen. You are waiting for the first calibration. It has been more than 10 hours after insertion of the sensor. It has been more than 10 hours after insertion of the sensor.
  • Page 115 Skin irritation at sensor insertion site. If the irritation is Around the edges of the adhesive or tape. Wherever the adhesive touches skin. The sensor support mount is not sticking to your skin. Respond to Alarms, Errors, and Problems a. Ensure that seams, waistbands, or other constrictive clothing or accessories do not cover the site causing friction.
  • Page 116 Section 10 Respond to Alarms, Errors, and Problems Discomfort when inserting the sensor. The system does not recognize a new sensor after attaching the transmitter to the sensor support mount. Your transmitter and receiver are not connected. Your receiver and transmitter are connected.
  • Page 117 You are not sure whether your receiver and transmitter are connected. You do not see the on the screen. You see the You see the the reconnect procedure was unsuccessful. You continue to see the icon even after replacing the battery in the transmitter.
  • Page 118 Section 10 Respond to Alarms, Errors, and Problems The system does not prompt you with a message to do BG test for calibration. The system did not prompt you with a message recognizing a new sensor after you attached the transmitter to the sensor support mount.

  • Page 119: Add Events

    11 Add Events...
  • Page 120 Section 11 – Key Terms events exercise event Generic event Insulin event LeFT/RIGhT Option Buttons Meal event State Of health event UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 121 11 Add Events Purpose To create a record of events that may affect your glucose levels. Start Do this procedure any time you observe anything that may affect your glucose levels, including your state of health and daily activities such as meals, exercise, and insulin dosages.
  • Page 122 Section 11 Add Events Steps Select the type of event you want to record. • Meals or snacks. • Details of an insulin dose. (injection or pump) • Exercise. • Your state of health. • Symptoms. • Other health related observations. •...
  • Page 123 Steps Record insulin events. History 08:30A Insulin 04-09-05 08:30 A Type: Rapid Units: 0.25 SAVE SAVE CANCEL Next Rapid Pre-Mix Intermediate Long Acting Record exercise events. History 08:30A Exercise 04-09-05 08:30 A Type: Jogging Duration: 0:30 Intensity: None SAVE SAVE Next CANCEL Aerobics...
  • Page 124 Section 11 Add Events Steps Record generic events. History 08:30A Generic 04-09-05 08:30 A Event: SAVE Next Check your work. Do This a. Use the LEFT Option button (Next) to select which item to enter or change (Event, SAVE/CANCEL, Date, Time). b.

  • Page 125: Review Reports And Edit Events

    12 Review Reports and Edit Events...
  • Page 126 Section 12 – Key Terms event history Reports events exercise event Generic event Glucose Targets Insulin event LeFT/RIGhT Option Buttons Line Graph Main Menu Meal event Multi-Day Statistics Reports Single-Day Statistics State Of health event Statistical Reports UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 127 12 Review Reports and Edit Events Purpose • To review your glucose levels. • To help you and your healthcare team detect patterns in your glucose levels relative to your targets. • To review a history of events that are important to your treatment plan. • To edit event history. Start • When you or your healthcare team want to know about your glucose levels or about events that may either explain your glucose levels or influence your treatment plan.
  • Page 128 Section 12 Review Reports and Edit Events Steps Decide what you want to do. • Set glucose targets. • See a line graph showing a history of your glucose levels. • See a statistical summary of your glucose levels over time. •...
  • Page 129 Steps View a line graph of your glucose level history. Select Time Period 08:30A 2 Hour 4 Hour 6 Hour 12 Hour 24 Hour back Select Note: The line graph display range is between 20 mg/dL (1.1 mmol/L) and 350 mg/dL (19.4 mmol/L).
  • Page 130 Section 12 Review Reports and Edit Events Steps View a statistical summary of your glucose levels. Stats 3 day Highest CM: 298 mg/dL Lowest CM: 61 mg/dL Ave. CM: 160 mg/dL Std. Dev: 80 mg/dL Above Target: 19% Next back Do This a.
  • Page 131 Steps Select the desired statistical reading. If you want to know • Your highest glucose reading. • Your lowest glucose reading. • Your average glucose reading. • How well you are maintaining your levels near the average value. • The percentage of readings that are above your high glucose target. • The percentage of readings that are within your glucose targets (between the high and low targets).
  • Page 132 Section 12 Review Reports and Edit Events Steps Review or change your event history. Select Filter CM 60 CM 120 CM 10 Insulin Back Select If you want to review/edit your • Continuous glucose measurements.* • Blood glucose readings.* • Insulin events. • Meal events. • Exercise events.
  • Page 133 Steps Interpret your events. Event (CM 60, CM 120, and CM 10) Insulin Meals Exercise State of Health Generic Alarm History User Events Review Reports and Edit Events Do This a. Interpret the events using the notes about each type of event in the table below: Notes • Each recorded measure is displayed on one screen with its...
  • Page 134 Section 12 Review Reports and Edit Events Steps Edit the event. Check your work. Do This Note: You CANNOT edit your glucose measurements. a. Press the RIGHT Option button (Edit). b. Use the LEFT Option button (Next) to select the item you want to change.

  • Page 135: Clean Your System

    13 Clean Your System...
  • Page 136 Section 13 – Key Terms Receiver Transmitter Contact Points Customer Care: 1-866-597-5520...
  • Page 137 13 Clean Your System Purpose To maintain the appearance of your system. Start Do this procedure: • Every time you change your sensor (transmitter). • Any time the system needs cleaning. Materials Make sure you have access to these materials before you begin: • Mild soap. • Running water. • A clean, soft, lint-free towel for cleaning and drying. For example, a dish towel. • 70% isopropyl alcohol. Helpful Information • Your FreeStyle Navigator system needs minimal maintenance aside from cleaning and battery replacement.

  • Page 138: Clean Your Transmitter

    Section 13 Clean Your System Steps Clean your transmitter. Clean your receiver skin. Clean your receiver. Check your work. Do This a. Wash the transmitter with mild soap and water. b. Rinse the transmitter thoroughly under running water. c. Dry the transmitter thoroughly with a clean, soft, lint- free towel.

  • Page 139: Link And Unlink Your Transmitter And Receiver

    14 Link and Unlink Your Transmitter and Receiver...
  • Page 140 Section 14 – Key Terms BG Mode CM Mode Link/Unlink Receiver Transmitter Customer Care: 1-866-597-5520...
  • Page 141 14 Link and Unlink Your Transmitter and Receiver Purpose To enable secure communication between your transmitter and your receiver. Start Do this procedure: • When you replace either your transmitter or your receiver. Materials Gather these materials before you begin: • Your receiver. • Your transmitter. Note: Your system may need fresh batteries if it cannot establish communication. Helpful Information Important: You will NOT receive continuous glucose data while the transmitter and receiver are unlinked and all alarms associated with the Continuous Monitoring mode will be turned off.
  • Page 142 Section 14 Link and Unlink Your Transmitter and Receiver Steps Decide what you want to do. • Unlink your receiver from your transmitter. • Link your receiver to your transmitter. • Check your work. Unlink your receiver from your transmitter. Link Blood Glucose Mode Relink to Transmitter Relink Do This If you want to a. Press the RIGHT Option button twice to display the 08:30A Main menu.
  • Page 143 Steps Link your receiver to your transmitter. Link 08:30A Searching For Transmitter Allow 70 Seconds Cancel Link 08:30A Transmitter ID: AAAF293-80359 located Is this yours? ID numbers • Are the same. • Are NOT the same. Verify that the ID number displayed on the screen is the same as the ID number on the bottom of your...
  • Page 144 Customer Care: 1-866-597-5520...

  • Page 145: Reset User Settings

    15 Reset User Settings...
  • Page 146 Customer Care: 1-866-597-5520...
  • Page 147 15 Reset User Settings Purpose To reset the user settings to the default values. Start Do this procedure anytime you feel a need to return your settings to the factory defaults. Materials Your FreeStyle Navigator Receiver. Helpful Information • If you don’t press any button within 12 seconds, the receiver screen will go blank and the last change will be lost if you haven’t pressed the Select button.
  • Page 148 Section 15 Reset User Settings Steps Access the Reset User Settings screen. System Menu 08:30A Status Link Set Date/Time Country Settings Reset User Settings Main Select Reset your settings. • Return your system to its default settings. • Change your mind. Are You Sure You Want To Reset to Default? Check your work.

  • Page 149: Change Country Settings

    16 Change Country Settings...
  • Page 150 Section 16 – Key Terms LeFT/RIGhT Option Buttons Receiver   System Menu   UP/DOwN Arrow Buttons Customer Care: 1-866-597-5520...
  • Page 151 16 Change Country Settings Purpose To set the date and time formats, the language, and the decimal format. Start Do this procedure when your requirements differ from the country setting currently being used by the system. Materials Gather these materials before you begin: • Your requirements for displaying date, time format and the other items mentioned in the purpose statement.
  • Page 152 Section 16 Change Country Settings Steps Access the Country Settings menu. System Menu Data Upload Status Link Set Date/Time Country Settings Main Select • Language. • Date. • Time. • Decimals. • None of the above. (you are done changing the country settings.) Change the Language. Country Settings Language (English) Date Format...
  • Page 153 Steps Change the Date Format. Country Settings 08:30A Language (English) Date Format (mm-dd-yy) Time Format (12h) Decimal Format (x. y) Back Select Change the Time Format. Country Settings 08:30A Language (English) Date Format (mm-dd-yy) Time Format (12h) Decimal Format (x. y) Back Select Change Country Settings...
  • Page 154 Section 16 Change Country Settings Steps Change the Decimal Format. Country Settings 08:30A Language (English) Date Format (mm-dd-yy) Time Format (12h) Decimal Format (x. y) Back Select Check your work. Do This a. Use the UP or DOWN Arrow button to highlight Decimal Format.

  • Page 155: Appendix A: Site Maintenance

    17 Appendix A: Site Maintenance...
  • Page 156 Section 17 – Appendix A Adhesive enhancers Antiseptics Dressings Site Rotation Skin Barriers Customer Care: 1-866-597-5520...
  • Page 157 17 Appendix A: Site Maintenance Introduction Careful site selection, preparation, and maintenance can help to lower the risk of infection and improve sensor adhesion. In addition to site selection, a number of helpful products are available. Site Selection Site rotation helps prevent discomfort, irritation, bruising, skin rashes, and sensitivity to adhesives. It is important for you to rotate across several sites and to insert sensors only in the abdomen or in the back of the upper arm.
  • Page 158 Customer Care: 1-866-597-5520...

  • Page 159: Appendix B: Specifications

    18 Appendix B: Specifications...
  • Page 160 Section 18 – Appendix B Calibration hematocrit Interstitial Fluid Receiver Transmitter Customer Care: 1-866-597-5520...

  • Page 161: System Specifications

    18 Appendix B: Specifications System Specifications Your FreeStyle Navigator system specifications are listed in the following table: Operating Temperature Storage Temperature Operating Humidity (Receiver) Operating and Storage Altitude Operating Pressure Sensor Life Sensor Operating Skin Surface Temperature Glucose Result Range Glucose Assay Method (for CM mode) Power Source...
  • Page 162 Depth: 0.88 in. (2.2 cm). 3.5 oz. (99.2 grams) – including batteries. Up to 60 days. Built-in blood glucose meter: 2 minutes after last user action. Receiver: 12 seconds after last user action. • 60 days of normal use including continuous glucose readings (stored every 10 minutes) and daily blood glucose readings.

  • Page 163: Performance Characteristics

    The FreeStyle Navigator system was calibrated with capillary finger- stick measurements using the built-in FreeStyle Blood Glucose Meter at approximately 10, 12, 24 and 72 hours after insertion of the sensor.All measurements were performed by a trained clinic study staff or the subject.
  • Page 164 Section 18 Appendix B: Specifications 18 Appendix B: Specifications Accuracy Table 1 below shows the distribution of all the data from the In-Clinic study on the Clarke Error Grid. Accuracy was assessed by comparing the differences between the FreeStyle Navigator system and the YSI laboratory reference. The Clarke Error Grid Analysis evaluates the clinical relevance of the differences by dividing a correlation plot (Figure 1) into five zones as described in Table 1.
  • Page 165 18 Appendix B: Specifications Table 2 is a summary of the statistics that describe how well data from the FreeStyle Navigator system correlates to the results from the reference method. Glucose results from the FreeStyle Navigator system and the corresponding results from the YSI (a total 20362 pairs of data points) in the In- Clinic study were used to determine the correlation.
  • Page 166 Section 18 Appendix B: Specifications 18 Appendix B: Specifications Performance Relative to the Reference (YSI) Error grid analysis (like the Clarke Error Grid Analysis and Continuous Glucose-Error Grid Analysis) is one way to evaluate the accuracy of the FreeStyle Navigator system. The accuracy can also be assessed by analyzing the difference in the glucose results from the FreeStyle Navigator system when compared to the results from the YSI.
  • Page 167 18 Appendix B: Specifications Performance Over the Duration of Wear This section presents the performance data in a variety of ways to demonstrate the performance of the system over time during the entire sensor wear period. The sensor is worn on the body for up to 5 days, during which time the system has to be calibrated 4 times.
  • Page 168 Section 18 Appendix B: Specifications 18 Appendix B: Specifications Stability of Sensor Calibration FreeStyle Navigator system typically requires a calibration at 10, 12, 24 and 72 hours after insertion of the sensor. This section presents information about the performance of the system by the 4 calibration periods.
  • Page 169 18 Appendix B: Specifications Figure 2. Sample of a Representative ‘Excellent’ Glucose Trace FreeStyle Navigator YSI Reference Figure 3. Sample of a Representative ‘ A verage’ Glucose Trace FreeStyle Navigator YSI Reference Figure 4. Sample of a Representative ‘Poor’ Glucose Trace FreeStyle Navigator YSI Reference (con’t)
  • Page 170 Section 18 Appendix B: Specifications 18 Appendix B: Specifications Determination of Alarm Performance The threshold alarm is characterized below. The projected alarm performance has not been established. The performance of low and high glucose alarms was assessed in an in-clinic study using 58 subjects with type 1 diabetes wearing one FreeStyle Navigator sensor on the arm and one sensor on the abdomen.
  • Page 171 18 Appendix B: Specifications Detection of Low Glucose See Table 7 below for detection of low glucose. As an example, when the threshold alarm was set at 70 mg/dL (during the day), 56 % of the low glucose events were detected by FreeStyle Navigator. Table 7.
  • Page 172 Section 18 Appendix B: Specifications 18 Appendix B: Specifications Measuring Glucose in Interstitial Fluid FreeStyle Navigator system measures glucose in the interstitial fluid (ISF) by means of a sensor that is inserted about 5 mm under the skin. Interstitial fluid is the fluid between the body’s cells. Physiologic differences between the interstitial fluid and capillary blood may result in differences in glucose measurements.

  • Page 173: Appendix C: Fcc Compliance Information

    19 Appendix C: FCC Compliance Information...
  • Page 174 Section 18 Appendix B: Specifications Customer Care: 1-866-597-5520...
  • Page 175 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information Electromagnetic Interference and Your FreeStyle Navigator® Continuous Glucose Monitoring System Important Information about Electromagnetic Interference The FreeStyle Navigator® Transmitter and Receiver communicate using radio frequency waves. The FreeStyle Navigator system has been designed to be reliable and immune to common electromagnetic interference so that it is not influenced by such interference.
  • Page 176 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t)
  • Page 177 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t)
  • Page 178 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t)
  • Page 179 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information (con’t)
  • Page 180 Section 19 Appendix C: Classification/Compliance/Declaration 19 Appendix C: FCC Compliance Information Caution: The radio receiver and transmitter of your FreeStyle Navigator system operate on the frequency of 433.6 MHz. Primary users of this frequency band include amateur “HAM” radio transmitters. Because of the coexistence of the FreeStyle Navigator radio connection and HAM transmitters, there may be instances where the connection between your transmitter and receiver may be lost when in proximity to HAM radio equipment.

  • Page 181: Declaration Of Conformity

    19 Appendix C: FCC Compliance Information Receiver Model Number: PRT03410-xxx. Operating Environment: For Home or Office Use. DECLARATION OF CONFORMITY Declare under our sole responsibility that the product Complies with Part 15 of FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
  • Page 182 Customer Care: 1-866-597-5520...

  • Page 183: Glossary

    20 Glossary...
  • Page 184 Section 19 Appendix C: Classification/Compliance/Declaration Customer Care: 1-866-597-5520...
  • Page 185 (performed in the Blood Glucose mode using the built-in FreeStyle Blood Glucose Meter). The receiver compares the reading it gets from the blood to the reading the sensor takes from the interstitial fluid. Based on the calibration, the receiver calculates real-time glucose readings.
  • Page 186 A test done with FreeStyle Control Solution in the Blood Glucose mode using the built-in Control FreeStyle Blood Glucose Meter to ensure that the system is working properly in the Blood Solution Test Glucose mode.
  • Page 187 20 Glossary (con’t) Glucose Trend Arrows shown on the receiver that let you know whether your glucose levels are stable, increasing, or decreasing, and how quickly they are changing. Arrows Hematocrit A measure of the amount of red blood cells in your body. High Glucose Notifies you when you go above your high glucose threshold (a number you and your healthcare Alarm...
  • Page 188 The receiver also has a built-in FreeStyle Blood Glucose Meter that works as a traditional blood glucose meter when a FreeStyle Test Strip is inserted into the test strip port. You can wear the receiver on your belt or carry it in your pocket or purse.
  • Page 189 20 Glossary (con’t) Reports Information about your glucose levels shown in a way to help you and your healthcare team analyze changes in your glucose levels and your treatment plan (such as changes in insulin doses, carbohydrate intake, etc.) Several types of reports are available. The part of the system that you insert under your skin.
  • Page 190 Section 20 Glossary 20 Glossary State of Health A record of health-related events, symptoms, and other observations that may help you see Event patterns in your glucose levels. A comprehensive summary of glucose results relative to your glucose targets. You can view Statistical Reports statistical reports for 1, 3, 7, 14, 21, or 28-day periods.

  • Page 191: Index

    21 Index...
  • Page 192 Customer Care: 1-866-597-5520...
  • Page 193 21 Index Add events 111 Adhesive Adhesion To Skin 40, 105 Adhesive Enhancers 147 Adhesive Removers 37 Alarms Change The Alarms 67 Mute Alarms 78 Respond To Alarms 89, 92 Glucose Alarms 67-74, 160, 161 Arrow Directional Glucose Trend Arrow 83, 84 Arrow Buttons 3 Average 121 Backlight 4, 85...
  • Page 194 Section 21 Index 21 Index (con’t) Icons 84 Insertion Sensor Insertion 41 Insertion Site 38, 39 Insulin 112, 113 Interference 165 Interstitial Fluid 1, 10, 162 Line Graph 4, 119 Link 131 Meals 112 Mode Continuous Monitoring Mode 12 Blood Glucose Mode 12 Mute Alarms 78 Receiver Clean Your Receiver 128...

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