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AgaMatrix WaveSense JAZZ Owner's Manual

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  • Page 2 It can be downloaded from the App Store or on Google Play Small size – The AgaMatrix WaveSense Jazz Wireless Meter is small and portable, for easy testing on the go. System Requirements (Meter and App) A compatible iOS or Android device.
  • Page 3 In case of emergency, contact your healthcare professional or emergency medical response. By using the AgaMatrix WaveSense JAZZ Wireless Blood Glucose Monitor- ing System (Meter) with the AgaMatrix Diabetes Manager (the App). You agree that the use of this software together with an iPod, iPhone or iPad (“Apple Product”) shall only be as a personal organization or supplemental...
  • Page 4 The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by AgaMatrix, Inc. is under license. Other trademarks and trade names are those of their respective owners. Apple, the Apple logo, iPhone and iPod touch are trademarks of Apple Inc., registered in the U.S.

  • Page 5: Table Of Contents

    Contents CHAPTER TITLE PAGE Important Information About Your AgaMatrix WaveSense JAZZ Wireless System The AgaMatrix WaveSense JAZZ Wireless System Kit About the Meter, Test Strips, and Lancing Device Meter and Lancing Device Basics Pairing and Syncing Your Meter with the App...
  • Page 6 CHAPTER TITLE PAGE Viewing Past Test Results on Your Meter Caring For Your Meter and Lancing Device Batteries Error Messages Troubleshooting AgaMatrix WaveSense JAZZ Wireless Meter Specifications Electrical Safety and Standards Symbols...

  • Page 7: Important Information About Your

    Owner’s Guide. Ensure that the retail carton has not been damaged. You should sync your meter to the AgaMatrix Diabetes Man- ager App (the App) to set your meter’s time and date before testing.
  • Page 8 The AgaMatrix WaveSense JAZZ Wireless blood glucose moni- toring system measures a glucose concentration in a sample of fresh capillary whole blood. WaveSense™ is the technology used in AgaMatrix Meters. After insertion of a test strip into the AgaMatrix WaveSense...
  • Page 9 [2] For self testing outside the body (In vitro diagnostic use), by people with diabetes at home (over the counter (OTC)), or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. [3] With AgaMatrix WaveSense JAZZ Test Strips and AgaMatrix...
  • Page 10 [5] Alternative site results should never be used to calibrate a continuous glucose monitor (CGM). [6] Alternative site results should never be used in insulin dose calculations. AgaMatrix WaveSense JAZZ Test Strips AgaMatrix WaveSense JAZZ Test Strips are for use with the AgaMatrix WaveSense JAZZ Wireless Blood Glucose Meter to...
  • Page 11 AgaMatrix Control Solutions are for use with the AgaMatrix WaveSense JAZZ Wireless Blood Glucose Meter and AgaMatrix WaveSense JAZZ Test Strips to check that the meter and test strips are working together properly and that the test is per- forming correctly.

  • Page 12: The Agamatrix Wavesense Jazz Wireless System Kit

    • Clear AST Lancing Device Cap • 30 Sterile Lancets • Compact Carrying Case • 1 Vial of 25 AgaMatrix WaveSense JAZZ Test Strips • AgaMatrix WaveSense JAZZ Test Strip Insert • AgaMatrix Control Solution • AgaMatrix Control Solution Insert •...

  • Page 13: About The Meter, Test Strips, And Lancing Device

    It is on the opposite side of the meter’s strip port. It is used to turn on the meter and view past glucose test results. (3) Test Strip Port: Insert the AgaMatrix WaveSense JAZZ Test Strip, with the contact bars facing up, into the test strip port.
  • Page 14 About the AgaMatrix WaveSense JAZZ Test Strips With your system, you can test your blood glucose on your fingertips. Testing with the system requires a small sample size, 0.5µL of blood, about the size of a pinhead. (1) Front of the Test Strip: The front of the test strip is black in color.
  • Page 15 Test Strips in their original vial only; never store them in another vial, any other container or outside the vial. • With clean, dry hands you may gently handle the AgaMatrix WaveSense JAZZ Blood Glucose Test Strip when removing it from the vial or inserting it into the meter.
  • Page 16 Glucose Test Strip. • Use AgaMatrix WaveSense JAZZ Blood Glucose Test Strips only once. • Only use AgaMatrix WaveSense JAZZ Blood Glucose Test Strips with the AgaMatrix WaveSense JAZZ and AgaMatrix WaveSense JAZZ Wireless Meters. • Dispose of used test strips properly.

  • Page 17: Meter And Lancing Device Basics

    Meter and Lancing Device Basics Meter Basics [1] Battery Installation: The batteries are pre-installed in the AgaMatrix WaveSense JAZZ Wireless Meter. [2] To Pair with a Secondary Device (iOS/Android): The meter is ready to be used right out of the box, however, if you want to sync readings from your meter to the App and set your meter’s time and date, you must pair your meter with the App.
  • Page 18 can manually add these readings to the App to include them in your statistics. [3] Review Mode: While the meter is off enter review mode by pressing the Meter Button. The most recent glucose test result will display. Each time the Meter Button is pressed the display will scroll to the next result in history.
  • Page 19 [4] Replace Lancing Device Cap: Replace the lancing device cap until it snaps into place. Be careful not to touch the ex- posed needle on the lancet. [5] Set the Lancing Level: The AgaMatrix Lancing Device offers 8 depth settings. Rotate the dial to the desired setting as shown in the depth indicator window.

  • Page 20: Pairing And Syncing Your Meter With The App

    The lancing device is now ready for use. Pairing and Syncing Your Meter with the App The AgaMatrix Diabetes Manager (“the App”) is an application that allows users to add, modify, and view health data, including glucose, insulin, carbs, and weight.
  • Page 21 Pair Versus Sync All devices that communicate via Bluetooth® wireless technology need to first “pair” with each other so they can establish a connection and get authorized to communicate with each other. You will only have to pair your meter to another device one time.
  • Page 22 [3] Tap on “Meters” [4] Tap “Add a new meter” [5] On your meter, press and hold the Meter Button. [6] Select your meter when it appears in the App. A 6-digit passkey will appear on the meter. Example image of a passkey: [7] Type the number into the App.
  • Page 23 How to Pair an Additional Meter You can pair your meter with up to 8 supported devices. Follow the same steps above to pair additional meters. How to Un-pair the App from the Meter [1] In the App, tap on the Menu icon, then tap on “Meters.” [2] Find the meter you wish to disassociate with your App by matching the serial number shown in the App to the number shown on the serial number label.
  • Page 24 For example: if your supported device is set to 12 hour time, the meter’s time will be set to 12 hour time. If your device is set to 12 hour time, you will see an “a” or “p” next to the time. Example of 12 hour time: Example of 24 hour time: For example: a date of “10/12”...

  • Page 25: Important Information About Performing Control Solution Tests

    All test result scorecards in the App that have been synced from the meter cannot be deleted. Important Information about Performing Control Solution Tests The AgaMatrix WaveSense JAZZ Wireless Blood Glucose Monitoring System should only be used with AgaMatrix Control Solution. The Control Solution is Used to: [1] Ensure that your meter and test strips are working together properly.

  • Page 26: Control Solution Tests

    [5] Are advised by your healthcare professional to do so. Important AgaMatrix Control Solution Information: [1] Use only AgaMatrix Control Solution with your AgaMatrix WaveSense JAZZ Wireless Meter. [2] Always shake the control solution bottle before use.
  • Page 27 Out-of-Range Test Results May Be Caused by: [1] Expired or defective control solution. [2] Expired or defective test strip. [3] Error in performing test. [4] Watered-down control solution. [5] Meter malfunction. [6] Control solution test done outside the system operating temperature of 10°C to 40°C (50°F to 104°F).

  • Page 28: How To Perform A Control Solution Test

    How to Perform a Control Solution Test [1] Inserting a Test Strip: Insert a test strip into the meter’s test strip port. Make sure you insert the test strip into the strip port with the contact bars facing towards you. The meter will turn on when the test strip is inserted.
  • Page 29 Apply Sample to Test Strip Animation: [3] Applying Control Solution: 1. Shake the control solution bottle. 2. Discard the first drop of control solution. 3. Wipe the bottle tip clean using a clean tissue or paper towel. 4. Dispense a second drop onto a clean surface, such as an unused resealable plastic bag.
  • Page 30 [4] Remove the Test Strip from Control Solution Sample When the Test Strip’s Visual Fill Window Completely Turns Blue: The entire visual fill window will turn blue. The sample applied symbol will appear on the meter’s screen and will beep when the meter recognizes the control solution and has enough to calculate a result.
  • Page 31 The control solution test result is stored in the meter’s memory but will not transfer to the App during syncing. Example Result: Compare the result of your control solution test to the range printed on your test strip vial label for the control solution level that you used.

  • Page 32: Before You Test Your Blood - Important Health-Related Information

    [6] Remove the Used Test Strip From the Strip Port: Control solution test results will not be sent to the App on your supported device. Removing the used test strip will turn off your meter. [7] Dispose of Used Materials Properly: Follow your healthcare professional’s instructions for disposal.
  • Page 33 inaccurate results. [4] Results below 3.9 mmol/L may mean low blood glucose levels (hypoglycaemia). [5] Results over 13.3 mmol/L may mean high blood glucose levels (hyperglycaemia). Checking ketones may be advisable. [6] If you get results below 3.9 mmol/L or above 13.3 mmol/L and do not have symptoms of hypoglycaemia or hypergly- caemia, repeat the test.
  • Page 34 [11] Always follow your healthcare professional’s recommendations. [12] Treatment goals are individualized for each patient. Speak with your healthcare professional about the target blood glucose ranges that are right for you. [13] Prior to performing a blood glucose measurement be sure the testing environment is between the operating temperature range of your system (found at the back of this guide).
  • Page 35 eating, taking insulin, or exercise. Changes in blood glucose may be detected in the fingertips, before the palm (at the base of the thumb) and forearm. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). It is recommended that you use a fingertip sample if: [1] You are testing for hypoglycaemia or if you suffer from hypoglycaemia unawareness.

  • Page 36: How To Test Your Blood Glucose Level

    How to Test Your Blood Glucose Level IMPORTANT: You must pair your meter to the App to be able to sync readings from your meter to the App and set your meter’s time and date. For instructions on how to pair refer to Chapter 5.
  • Page 37 [3] Lance the Test Site: Press the lancing device against the site to be lanced. Press the release button. For instructions on how to test on your palm or forearm, please refer to Chapter 10. Release Button [4] Obtain a Drop of Blood: Squeeze from the base of your finger up towards the tip, milking your finger, until a small blood drop forms.
  • Page 38 The test strip acts like a sponge and draws the blood into the test strip through the sample area. The visual fill window of the test strip will turn red indicating blood has been absorbed in the test strip. This is the visual fill window.
  • Page 39 visual fill window is completely full. The calculating animation will begin on the meter display. This animation indicates that a sample has been applied to the test strip and the meter is calculating the test result. Calculating Animation: IMPORTANT: • Remove the test strip from the blood sample as soon as the test strip’s visual fill window completely turns red (you will also hear a beep).
  • Page 40 [7] Viewing Blood Glucose Test Result: The blood glucose test result will appear on the meter display. Results will be dis- played in mmol/L. Example Result: The test result is stored in the meter’s memory. Carefully read the test results on the meter screen before making any treatment decisions.
  • Page 41 follow the treatment plan recommended by your healthcare team or contact your healthcare professional immediately. HIGH MESSAGE: Glucose test result is above 33.3 mmol/L. This high result may indicate hyperglycaemia (high blood glucose). The high result is stored in the meter. On the App it will be saved as a test result of >33.3 mmol/L with time and date.
  • Page 42 Removing the used test strip will turn off your meter. If you leave the test strip in your meter, it will time out after 90 seconds. [9] Final Steps: Remove the Lancet: When you have finished testing, snap off the cap from the lancing device. Be careful not to touch the lancet tip.
  • Page 43 snaps or clicks into place. Discard the used lancet properly. Follow your healthcare professional’s instructions for disposal. WARNING: The information from the App should only be used as a reference. Do not make treatment decisions based solely on the information provided by the App. All health-related decisions should be made in conjunction with the advice of a qualified healthcare professional (HCP).

  • Page 44: Obtaining A Blood Sample From Alternative Sites

    Obtaining a Blood Sample From Alternative Sites (Palm or Forearm) Testing glucose levels with blood obtained from the palm (at the base of the thumb) or forearm may reduce the pain of testing. The technique for testing on the palm and forearm is slightly different than testing on the finger.
  • Page 45 Alternative site results should never be used to calibrate a continuous glucose monitor (CGM). Alternative site results should never be used in insulin dose calculations. It is recommended that you use a fingertip sample if: • You are checking for hypoglycaemia or if you suffer from hypoglycaemia unawareness, •...
  • Page 46 [2] Follow Chapter 9 to prepare for glucose testing. [3] Rub Test Site: To increase the blood flow in your palm (at the base of the thumb) or forearm, rub the area that you will be testing. Ensure that your palm or forearm is facing up and held level.

  • Page 47: Viewing Past Test Results On Your Meter

    Viewing Past Test Results on Your Meter The meter will store up to 300 of the most recent blood glucose and control solution test results. When the meter reaches the 300 test result capacity, the oldest test result will be deleted and a new test result will be saved. Note: If the meter has been synced with the App, glucose test results can be reviewed in the App even after they have been deleted from the meter.

  • Page 48: Caring For Your Meter And Lancing Device

    recent and ending with the oldest. When you reach the oldest reading stored on the device, you will see a brief animation before the most recent reading is displayed again. [3] Turning Off Your Meter: The meter will turn off (time out) automatically after 30 seconds.

  • Page 49: Batteries

    Batteries CR2032 CR2032 Your meter comes with two pre-installed CR2032, 3 volt, lithium batteries. CR2032 CR2032 Two replacement CR2032, 3 volt, lithium batteries are included in the pocket of your meter’s carrying case. Batteries are harmful if swallowed. Keep away from small children.
  • Page 50 and date. To sync your meter, see instructions in Chapter 5. Removing the batteries does not affect the stored glucose records. NOTE: Dispose of used batteries according to your local environ- mental regulations. Your meter is also an electronic device. When disposing of your meter, follow all local environmental regulations.
  • Page 51 [3] Install the New Batteries: Install the new batteries with the positive (+) sign facing up towards you. CR2032 CR2032 [4] Close Battery Door: Slide the battery door onto the meter. Make sure that the battery door is completely closed before using the meter.

  • Page 52: Error Messages

    Error Messages The AgaMatrix WaveSense JAZZ Wireless Meter is designed to work accurately under most usual conditions. On rare occasions, the meter will display an error message instead of a glucose result. The meter is able to detect specific problems which may allow you to determine the cause of the error without wasting valuable test strips.
  • Page 53 have been removed too early. Retest using a new test strip. [3] If this message appears after the 1-2-3 countdown instead of a result, it may indicate that you applied more blood after testing began. Error 2: The meter has detected an irregularity with the sample. [1] The test strip may be partially filled.
  • Page 54 [4] The test strip port on your meter may be dirty. Call Customer Care for assistance. The phone number is printed on the back of your meter. Error 4: The meter was unable to produce a result or unusual test strip problems have occurred that may be related to ex- treme conditions.
  • Page 55 [1] This may be caused by a combination of cold operating temperature and high haematocrit levels. Retest in a warmer location. [2] If this error code persists on retesting, call Customer Care. The phone number is printed on the back of your meter. Error 7: Meter problems have occurred that are beyond your control.

  • Page 56: Troubleshooting

    to reach the new temperature (usually 10-20 minutes) before using the meter or performing a test. HIGH TEMPERATURE MESSAGE: The meter is above its operating temperature range of 10°C to 40°C (50°F to 104°F). ACTIONS: Move to an area with an ambient temperature of 10°C to 40°C (50°F to 104°F).
  • Page 57 the back of your meter. [4] CAUSE: Blood or foreign objects put into the meter test strip port. ACTION: Call Customer Care. The phone number is printed on the back of your meter. Troubleshooting Situation #2: After applying the blood sample, the meter doesn’t begin the Calculating Animation and no test result is displayed.
  • Page 58 device. If the meter is already paired, but not syncing, follow the instructions in that chapter to force sync your devices. [2] CAUSE: Bluetooth on supported device is not on. ACTION: Go to the settings menu in your supported device and ensure that Bluetooth is turned on.

  • Page 59: Agamatrix Wavesense Jazz Wireless

    AgaMatrix WaveSense JAZZ Wireless Meter Specifications Assay Method: Dynamic Electrochemistry Maximum Altitude: 3,048 meters Calibration: Plasma equivalent Coding: No Code Control Solution Storage Temperature: 2°C to 30°C (36°F to 86°F) Sample: Whole blood, capillary Blood Sample Size: 0.5 microliters Average Glucose Test Time: 5 seconds Measurement Units: mmol/L Result Range: 1.1 to 33.3 mmol/L...

  • Page 60: Electrical Safety And Standards

    If you continue to experience interference, contact Customer Care. The AgaMatrix WaveSense JAZZ Wireless Meter complies with U.S. federal guidelines, Part 15 of the FCC rules. These rules state two conditions specific to the operation of the device:...
  • Page 61 This device must accept any interference received, including interference that may cause undesirable operation. FCC guidelines help ensure that the AgaMatrix WaveSense JAZZ Wireless Meter will not affect the operation of other nearby electronic devices. Additionally, other electronic de- vices should not affect the use of your meter.

  • Page 62: Symbols

    Symbols Serial Number: Manufacturer: In Vitro Diagnostic Medical Device: Batch Code: Consult Instructions For Use: Do Not Reuse: Temperature Limitation: Use By: Catalogue Number: Sterile: European Authorised Representative:...
  • Page 64 8100-10145 Rev B...

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