Download
Share
Print this page
AgaMatrix Agile Owner's Manual
  1. Manuals
  2. Brands
  3. AgaMatrix Manuals
  4. Blood Glucose Meter
  5. Agile
  6. Owner's manual
AgaMatrix Agile Owner's Manual

AgaMatrix Agile Owner's Manual

Advanced blood glucose monitoring system
Hide thumbs Also See for Agile:

Advertisement

Quick Links

Download this manual

Advertisement

loading
Need help?

Need help?

Do you have a question about the Agile and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for AgaMatrix Agile

Summary of Contents for AgaMatrix Agile

  • Page 2 Welcome to Your New AgaMatrix Agile™ Blood Glucose Monitoring System The AgaMatrix Agile Blood Glucose Meter is designed to work with the AgaMatrix Diabetes Manager, an iOS or Android application (app) installed on a supported device. Data is transmitted between the AgaMatrix Agile Meter and the AgaMatrix Diabetes Manager app via Bluetooth®...
  • Page 3 In case of emergency, contact your healthcare professional or emergency medical response. By using the AgaMatrix Agile Blood Glucose Monitoring 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 organisation or supplemental...
  • Page 4 For patent information, see www.agamatrix.com/patents 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.

  • Page 5: Table Of Contents

    CHAPTER TITLE PAGE Important Information About Your AgaMatrix Agile System The AgaMatrix Agile System Kit About the Meter, Test Strips, and Lancing Device Pairing and Syncing Your Meter with the App Important Information about Performing Control Solution Tests How to Perform a Control Solution Test Before you Test your Blood –...
  • Page 6 CHAPTER TITLE PAGE Caring For Your Meter and Lancing Device Batteries Error Messages Troubleshooting AgaMatrix Agile Meter Specifications Electrical Safety and Standards Symbols...

  • Page 7: Important Information About Your Agamatrix Agile System

    Owner’s Guide. Ensure that the retail carton has not been damaged. You should sync your meter to the AgaMatrix Diabetes Manager app (the app) to set your meter’s time and date before testing. This will ensure that results from meter are sent wirelessly to the app.
  • Page 8 Small items such as test strips, lancets, protective covers on the lancets, and control solution vial cap are choking hazards. Do not ingest or swallow any items. AgaMatrix Agile Blood Glucose Monitoring System Test Principle: The AgaMatrix Agile blood glucose monitoring system measures a glucose concentration in a sample of fresh capillary whole blood.
  • 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 Agile Test Strips and AgaMatrix Control...
  • Page 10 [6] Alternative site results should never be used in insulin dose calculations. AgaMatrix Agile Test Strips AgaMatrix Agile Test Strips are for use with the AgaMatrix Agile Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the...
  • Page 11 AgaMatrix Control Solutions AgaMatrix Control Solutions are for use with the AgaMatrix Agile Blood Glucose Meter and AgaMatrix Agile Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

  • Page 12: The Agamatrix Agile System Kit

    • Two Pre-installed CR2032, 3 Volt, Lithium Batteries • Lancing Device with Cap • 10 Sterile Lancets • Compact Carrying Case • 1 Vial of 10 AgaMatrix Agile Test Strips • AgaMatrix Agile Test Strip Insert • AgaMatrix Control Solution • AgaMatrix Control Solution Insert •...

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

    About the Meter, Test Strips, and Lancing Device About the AgaMatrix Agile meter Please note the correct orientation of the device in the sample image below. (1) Display Area: Glucose test results, symbols, and messages appear here. Inspect the display for damage by viewing the Intro Animation.
  • Page 14 About the AgaMatrix Agile 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 colour.
  • Page 15 • Apply only fresh capillary blood or control solution to the sample area of the test strip. • Use AgaMatrix Agile Blood Glucose Test Strips only once. • Only use AgaMatrix Agile Blood Glucose Test Strips with the AgaMatrix Agile meter.
  • Page 16 About the AgaMatrix Lancing Device (1) Cocking Handle: Cocks the device so it is ready to lance. (2) Depth Selector Dial: Adjusts how deep the lancet will lance the skin. (3) Depth Indicator Window: Select from 5 levels of depth for skin penetration.

  • Page 17: Pairing And Syncing Your Meter With The App

    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. We recommend downloading the latest version of the app.
  • Page 18 the latest security software. For more information on keeping your supported device and information safe, please contact the manufacturer of your supported device. 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 authorised to communicate with each other.
  • Page 19 [2] Navigate to the Menu: Tap on the icon made of three lines. [3] Tap on “Meters” [4] Tap “Add a new meter” [5] On your meter, press and hold the Meter Button. [6] Tap on your meter’s serial number when it appears in the app.
  • Page 20 Note: Test results taken prior to the time and date being set will not have a time and date associated with them on the meter. You can manually add these readings to the app to include them in your statistics. Test results without a set time and date will be displayed on your meter with “--:--“...
  • Page 21 How to Pair with Multiple Supported Devices You can pair your meter with up to 7 supported devices. Before pairing with an additional supported device, turn off Bluetooth® on any devices already paired with your meter. This will ensure connection with your additional supported device.
  • Page 22 Time and Date The time and date settings on the meter are configured to match the supported device’s time and date settings. 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”...
  • Page 23 Airplane Mode You can keep your meter paired with your supported device while flying, just turn Bluetooth on while the device is in Airplane mode. Force Data Transfer (Sync) If you suspect that data is not being transferred from the meter to the app, you can force the two to sync.

  • Page 24: Important Information About Performing Control Solution Tests

    Important Information about Performing Control Solution Tests The AgaMatrix Agile 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 25 Important AgaMatrix Control Solution Information: [1] Use only AgaMatrix Control Solution with your AgaMatrix Agile Meter. [2] Always shake the control solution bottle before use. [3] Always discard the first drop of control solution and wipe the bottle tip clean using a clean tissue or paper towel.
  • Page 26 [6] Control solution test done outside the system operating temperature of 10°C to 40°C (50°F to 104°F). [7] Failure to shake the control solution bottle vigorously before using. [8] Failure to discard the first drop of control solution and to wipe the bottle tip clean.

  • Page 27: 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 28 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 29 [4] Remove test strip from the control solution sample when the visual fill window completely turns blue and the meter beeps: The entire visual fill window will turn blue. The sample applied symbol will appear on the meter’s screen. Sample Applied Symbol: The calculating animation will begin on the meter display.
  • Page 30 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. Your control solution result should fall within this range. Example Result: Normal (Level 2): 5.0-9.5 mmol/L High (Level 4) : 12.2-17.8 mmol/L FOR EXAMPLE ONLY.

  • Page 31: Before You Test Your Blood - Important Health-Related Information

    Removing the used test strip will turn off your meter. [7] Dispose of Used Materials Properly: Follow your healthcare professional’s instructions for disposal. Before you Test your Blood – Important Health-Related Information [1] Inaccurate results may occur in severely hypotensive individuals or patients in shock.
  • Page 32 [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 hyperglycaemia, repeat the test.
  • Page 33 [12] Treatment goals are individualised 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 34 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. [2] You are testing your blood glucose within 2 hours of eating, taking insulin, medication, exercise.

  • Page 35: 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 4.
  • Page 36 Insert New Lancet: Insert a new lancet firmly into the lancet holder as shown in the picture below. Pushing the lancet into the lancet holder cup may cock device; this is OK. Twist the Lancet Cover Off: Hold the lancet firmly in place with one hand and use your other hand to twist off the lancet cover.
  • Page 37 Level 1 is the shallowest; level 5 is the deepest. If you have never lanced before, it is recommended that you start at level 3. Cock the Handle: Pull the cocking handle out until it clicks. You may have already cocked the handle while inserting the lancet, this is OK.
  • Page 38 [4] 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 9. Release Button [5] 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 39 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. Do not apply blood here. APPLY BLOOD HERE [7] Remove Your Finger From the Test Strip When the Test Strip’s Visual Fill Window Completely Turns Red and the Meter Beeps: the sample applied symbol will appear on the...
  • Page 40 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 41 glucose test result. 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. Glucose Display Messages CAUTION: Low or high blood glucose test results can indicate a potentially serious medical condition.
  • Page 42 HIGH MESSAGE: Glucose test result is above 33.3 mmol/L. This high result may indicate hyperglycaemia (high blood glucose). It also indicates that the result is above our measuring range. 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 43 If the Fasting Tag is selected, Fasting Tag icon will scroll to the right of the blood glucose test result along with the date, time, and unit of measure (mmol/L). Example Result with Fasting Tag: IMPORTANT: By default, the blood glucose result will not be marked with a Fasting Tag.
  • Page 44 Place the lancet cover onto a hard, even surface (such as a tabletop). While the lancet is still in the lancing device, bring the lancet tip to the lancet cover to recover the used lancet. You can then safely remove the used lancet.
  • Page 45 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). It is important that you and your HCP understand how the statistics are calculated before making any adjustments to treatment.

  • Page 46: Obtaining A Blood Sample From Alternative

    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 frequent testing. The technique for testing on the palm and forearm is slightly different than testing on the finger.
  • Page 47 Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly). 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: •...
  • Page 48 [2] Follow Chapter 8 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 49: Viewing Past Test Results On Your Meter

    Viewing Past Test Results on Your Meter The meter will store up to 1,000 of the most recent blood glucose and control solution test results. When the meter reaches the 1,000 test result capacity, the oldest test result will be deleted and a new test result will be saved. Note: If the meter is synced with the app, glucose test results can be reviewed in the app even after they have been deleted from the meter.

  • Page 50: Caring For Your Meter And Lancing Device

    These readings will not sync to the app. [2] Viewing All Stored Test Results: Continue pressing the Meter Button to view every test result, starting from the most 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.

  • Page 51: Batteries

    Batteries Your meter comes with two pre-installed CR2032, 3 volt, lithium batteries. CR2032 CR2032 Batteries are harmful if swallowed. Keep away from small children. LOW BATTERY MESSAGE: (This message appears for 2 seconds.) You can still perform a test when you see a low battery message, but you should replace your batteries as soon as possible.
  • Page 52 IMPORTANT: When the batteries are replaced, the time and date will be erased from your meter. You must sync your meter with your supported device to ensure your readings have time and date. To sync your meter, see instructions in Chapter 4.
  • Page 53 [3] Install the New Batteries: Install the new batteries with the positive (+) sign facing up towards you. [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 54: Error Messages

    Error Messages The AgaMatrix Agile 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 55 [2] If the message appears during a test, the test strip may 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.
  • Page 56 [3] Parts of the test strip may have become covered in grease, oil, or lotion. Retest using a new test strip. [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.
  • Page 57 Error 6: The test strip has taken too long to generate a signal. [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.
  • Page 58 If there is a temperature warning or error, the thermometer symbol is displayed for 5 seconds and then the meter turns off. LOW TEMPERATURE MESSAGE: The meter is below 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 59: Troubleshooting

    Troubleshooting Troubleshooting Situation #1: Meter does not display the Apply Sample to Test Strip Animation after inserting a test strip. [1] CAUSE: The meter’s batteries have insufficient power. ACTION: The meter’s batteries must be changed immediately. Sync the meter with your supported device to set the date and time.
  • Page 60 [1] CAUSE: Defective test strip. ACTION: Repeat the test with a new test strip. If this does not work, call Customer Care. The phone number is printed on the back of your meter. [2] CAUSE: Sample was applied after 90 seconds of inserting a test strip.
  • Page 61 metres of each other. ACTION: Bring your meter and supported device next to each other and attempt to force sync the two devices. [4] CAUSE: The blood glucose test results do not have a time and date and show “--:--“ and “--/--“ in place of the time and date.
  • Page 62 Troubleshooting Situation #4: Meter is paired with more than one supported device but results are not syncing to all supported devices. (For example, your meter is paired with an iPhone® and Android™ phone, but results are only syncing to the iPhone®). CAUSE: Meter only establishes a connection with one supported device at a time.
  • Page 63 Troubleshooting Situation #6: Passkey does not appear on the meter when pairing with a supported device. [1] CAUSE: The meter has previously been paired with the supported device. ACTION: If the meter was paired with a supported device and then unpaired, a passkey may not be required when pairing again with the same supported device.
  • Page 64 ACTION: Remove batteries, wait 30 seconds, then re-install batteries. Sync meter with your supported device before attempting another test. If this problem continues please call customer service. Troubleshooting Situation #8: The time and date on the meter do not match the time and date on the supported device. CAUSE: Meter has not recently synced with your supported device.

  • Page 65: Agamatrix Agile Meter Specifications

    AgaMatrix Agile 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 ° ° ° ° Sample: Whole blood, capillary Blood Sample Size: 0.5 microliters...

  • Page 66: Electrical Safety And Standards

    If you continue to experience interference, contact Customer Care. The AgaMatrix Agile 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 67 This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesirable operation. FCC guidelines help ensure that the AgaMatrix Agile Meter will not affect the operation of other nearby electronic devices. Additionally, other electronic devices should not affect the use of your meter.

  • Page 68: 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: Units of Measure:...
  • Page 70 8100-10554 Rev B...