AgaMatrix Jazz Wireless 2, Owner'S Manual

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Page 2: ... 2 Meter uses Bluetooth wireless technology for an easy to use wireless connection to supported devices Seamlessly Sync Results to App Use the AgaMatrix Jazz Wireless 2 Meter with the AgaMatrix Diabetes Manager App to sync glucose results directly to your iOS or Android de vice The App can be used to conveniently store and manage your diabetes information review trends or share with your healthcar...

Page 3: ...t at any time rely on any information presented on your Apple Product as the basis for health care medical or other decisions that may result in injury or other ill effects You agree to take sole responsibility for your health care decisions including contacting a physician or other health care professional regarding all medical conditions tests diagnoses and treatment options and agree that Apple...

Page 4: ...nd 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 and other countries App Store is a service mark of Apple Inc Android is a trademark of Google Inc Google Play is a ...

Page 5: ... 2 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 Important Health related Information How to Test Your Blood Glucose Level Viewing Past Test Results on Your Meter 5 10 11 11 16 23 26 30 33 42 ...

Page 6: ...E 11 12 13 14 15 16 17 Important Cleaning and Disinfection Procedures Batteries Error Messages Troubleshooting AgaMatrix Jazz Wireless 2 System Specifications Electrical Safety and Standards Warranty 43 48 50 55 60 61 64 ...

Page 7: ...t home as an aid to monitor the effectiveness of diabetes control The AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System is not intended for use in diagnosis of or screening for diabetes and not intended for use in neonates For use with AgaMatrix Jazz Test Strips and AgaMatrix Control Solution only Do not use other brands of test strips and con trol solution with this meter as this may prod...

Page 8: ...ites other than samples drawn from the fingertip Getting Started This Owner s Guide is intended to instruct the user on how to use the meter Your meter is ready to use right out of the box Unpack your system Check that all system kit contents are included there is a list of kit contents in this Owner s Guide Ensure that the retail carton has not been damaged You should sync your meter to the AgaMa...

Page 9: ...r town Follow your healthcare professional s instructions for disposal In case of emergency contact your healthcare professional or emergency medical response Keep the meter and testing supplies away from young children 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 Jazz Wireles...

Page 10: ...0 mg dL glucose Capillary whole blood samples with a hematocrit range of 20 to 60 can be measured The AgaMatrix Jazz Wireless 2 Meter is calibrated to provide a glucose concentration for a capillary whole blood sample that is equivalent to the plasma glucose concentration of that sample AgaMatrix Jazz Test Strips AgaMatrix Jazz Test Strips are for use with the AgaMatrix Jazz Wireless 2 Blood Gluco...

Page 11: ...hould sync your meter to 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 See Chapter 5 for more information Supported Devices The AgaMatrix Diabetes Manager the App is an application that allows users to add modify and view health data includ ing glucose insulin carbs and weight The App works on a variety of iOS and A...

Page 12: ...instructions for disinfecting your meter and lanc ing device please read Chapter 11 The Food and Drug Administration FDA and the Center for Disease Control CDC have issued warning and notifications regarding the risk of bloodborne pathogen transmission when blood glucose monitoring systems have been used by more than one individual Please read the following references for more information FDA Publ...

Page 13: ...cing Device with Cap 10 Sterile Lancets Compact Carrying Case 1 Vial of 10 AgaMatrix Jazz Test Strips AgaMatrix Jazz Test Strip Insert AgaMatrix Jazz Wireless 2 Owner s Guide Getting Started Meter Pairing Syncing Guide Registration Card The System Kit Contains About the AgaMatrix Jazz Wireless 2 Meter Please note the correct orientation of the device in the sample image below About the Meter Test ...

Page 14: ...Meter Button The button is the circle on the front of the meter 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 Jazz Test Strip with the contact bars facing up into the test strip port Note The batteries are pre installed in the meter About the AgaMatrix Jazz Test Strips With your system ...

Page 15: ...ont of the test strip facing towards you into the meter s test strip port 4 Sample Area Blood or control solution should be applied to the tip of the test strip here 5 Visual Fill Window This window will turn red when enough blood has been applied or blue when enough control solution has been applied Important Test Strip Information Store the AgaMatrix Jazz Blood Glucose Test Strip vial in a cool ...

Page 16: ...ation date or 180 days after first open ing the vial This may cause inaccurate results Write the discard date 180 days from the first opening on the test strip vial Do not bend cut or alter AgaMatrix Jazz Blood Glucose Test Strips Apply only fresh capillary blood or control solution to the sample area of the AgaMatrix Jazz Blood Glucose Test Strip Use AgaMatrix Jazz Blood Glucose Test Strips only ...

Page 17: ...Depth Indicator Window Displays the depth setting of the lancing device 4 Release Button Fires the lancet 5 Lancet Holder Cup Holds the lancet into place inside the lancing device 6 Lancing Device Cap Covers the lancet when in lancing device 7 Lancet Lances the skin to produce a drop of blood 8 Lancet Cover Covers the lancet for safety Remove after inserting into the lancet holder cup ...

Page 18: ...he meter screen is activated Compatibility The app works on a variety of iOS and Android devices To see an updated list visit your meter manufacturer s website The App can be downloaded for free from the App StoreSM on your iPhone or iPod touch or on Google Play on your Android device IMPORTANT Please note that the App stores sensitive health related information on your supported device We recomme...

Page 19: ...ity 10 feet of your paired device and the meter screen is activated Pairing for the First Time Before pairing your meter with the App for the first time the App must be installed on your supported device Ensure that the date and time on your supported device is correct Note Test results without a set time and date will be saved to the meter in chronological order but will not sync to the App when ...

Page 20: ...der the meter battery door 7 Enter the passkey A 6 digit passkey will appear on the meter Type the number into the App Example image of a passkey 8 Confirm pairing is successful Both the meter and the App will indicate that pairing was successful The meter will have a check symbol and the App will show a message Example image of a check symbol The meter and the App must be within 10 feet of each o...

Page 21: ...e meter cannot be deleted from the App To prevent test results from other people being sent to your supported device 1 Do not let another person test their blood glucose with your meter This meter is for single patient use only 2 Do not pair or sync a meter used by another person with your supported device If you pair with another person s meter the data from each meter will be combined in the App...

Page 22: ...shown on the serial number label You can find this label under the meter battery door 3 Swipe left on the selected meter Tap on forget The meter will no longer transfer data to the App Automatic Data Transfer Sync The first time your meter pairs with your supported device it will set the date and time on your meter Every time your meter and supported device are within 10 feet of each other and the...

Page 23: ...c 10 if your supported device is set to DD MM 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 and will not sync to the App 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 and in place of the time and date Airpla...

Page 24: ...e are no meters listed you must pair your meter to your App See pairing instructions at the start of this chapter 3 If you see your meter listed tap on the Sync button 4 Press the Meter Button on your meter to activate the screen All new data will transfer to the App and the meter will be set with the time and date of your supported device All test result scorecards in the App that have been synce...

Page 25: ...ure that your meter and test strips are working together properly 2 Practice testing without having to use your own blood Control Solution Tests Should Be Performed When You 1 First get your meter 2 Suspect that your meter or test strips are not working properly 3 Think your test results are not accurate 4 Have dropped or damaged your meter or exposed your meter to liquids 5 Are advised by your he...

Page 26: ... control solution bottle immediately after use 5 Do not add water or any other liquid to control solution 6 Control solution tests should be performed within the system operating temperature range of 50 F to 104 F 10 C to 40 C and an operating relative humidity range of 10 90 Out of Range Test Results May Be Caused by 1 Expired or defective control solution 2 Expired or defective test strip 3 Erro...

Page 27: ...rol solution and to wipe the bottle tip clean IMPORTANT Control solution should only be used for 90 days after first opening the bottle or until the expiration date printed on the label whichever comes first CAUTION Results from control solution tests do not reflect your blood glucose level The control solution range is a target range for control solution only It is not a target range for your blo...

Page 28: ...nsert 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 2 Meter Ready for Test The meter will then display the Ap ply Sample to Test Strip Animation indicating it is now ready for you to apply control solution You do not need to set a calibration code for this meter ...

Page 29: ...urface such as an unused resealable plastic bag 5 Avoid handling the test strip s sample area where con trol solution should be applied 6 Bring the tip of the test strip to the control solution sample at a 90 degree angle immediately so that the control solution does not evaporate The meter will automatically detect if a test is performed with control solution Apply control solution here This is t...

Page 30: ...ating 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 5 Viewing Control Solution Test Result The control solution test result will appear on the meter display The date time and unit of measure mg dL will scroll to the right of the control solution test result The c...

Page 31: ...ange Example Result If Your Control Solution Test Results Are Out of the Range Repeat the test and refer to Chapter 13 of this guide to see potential causes of error If the results from the control solution tests continue to fall outside that range do not use the meter to test your blood glucose Call Customer Service The phone number is printed at the start of this guide and also printed on the ba...

Page 32: ... Information 8 CHAPTER 1 Inaccurate results may occur in severely hypotensive individuals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycemic hyperosmolar state with or without ketosis This device should not be used to test critically ill patients 2 Severe dehydration and excessive water loss may yield inaccurate results If you believe you are sufferi...

Page 33: ...not consistent with your blood glucose test and you have followed all instructions described in this Guide follow your healthcare professional s recommendations 8 If you get repeated error messages and are experiencing symptoms of hypo or hyperglycemia contact your healthcare professional immediately as this may indicate low or high glucose If this error code persists on retesting consult your hea...

Page 34: ...t using blood from the tip of any finger CAUTION To ensure accurate results and reduce chance of infection and disease spread by blood wash your hands and the test site with warm soapy water rinse and dry thoroughly before every test Unwashed hands and test sites may lead to inaccurate results Make sure there is no grease oil or lotion on the test site Use lancets only once Do not use any lancing ...

Page 35: ... a set time and date will be displayed on your meter with and in place of the time and date 1 Prepare the Lancing Device Remove Lancing Device Cap Snap off the cap from the lanc ing device Insert New Lancet Insert a new lancet firmly into the lancet holder cup 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 ...

Page 36: ...ice offers 8 depth settings Rotate the dial to the desired setting as shown in the depth indicator window Level 1 is the shallowest level 8 is the deep est 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 The lancing device is now ready...

Page 37: ...s now ready for you to apply blood You do not need to set a calibration code for this meter Apply Sample to Test Strip Animation 4 Lance the Test Site Keep your hand warm or gently mas sage the site you are lancing to stimulate blood flow Press the lancing device against the site to be lanced Press the release button 5 Obtain a Drop of Blood Squeeze from the base of your finger up towards the tip ...

Page 38: ...ediately bring the meter with the inserted test strip to the blood sample at a 90 degree angle The test strip fills from the tip Do not try to smear blood on the top surface 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 ...

Page 39: ...emove the test strip from the blood sample CAUTION If the visual fill window does not completely fill you may get an inaccurate result Retest and ensure that the 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 T...

Page 40: ...e meter Do not put blood or foreign objects into the test strip port Do not apply more blood after the test strip s visual fill window completely turns red and the calculating anima tion begins on the meter s display 8 Viewing Blood Glucose Test Result The blood glucose test result will appear on the meter display The date time and unit of measure mg dL will scroll to the right of the blood glucos...

Page 41: ...tistics in the App ACTIONS If you feel symptoms such as weakness sweating nervousness headache or confusion follow your healthcare professional s recommendations If you get a low glucose test result but have no symptoms of low blood glucose then retest with a new test strip If you still get a low test result follow the treatment plan recommended by your healthcare team or contact your healthcare p...

Page 42: ...ur healthcare professional s recommendations Checking ketones may be advisable If you feel that your results do not match with how you are feeling contact your doctor or nurse 9 Remove the Used Test Strip From the Meter Test Strip Port Avoid touching the test strip s sample area where blood was applied Removing the used test strip will turn off your meter If you leave the test strip in your meter ...

Page 43: ... recover the used lancet You can then safely handle the used lancet Extract the lancet from the lancet holder cup by pulling and twisting on the plastic collar of the lancet near the middle of the lancet Replace the lancing device cap onto the lancing device until it snaps or clicks into place Discard the used lancet properly Follow your healthcare professional s instructions for disposal ...

Page 44: ...p User s Guide accessible from the App The meter will store up to 300 of the most recent blood glucose and control solution test results When the meter reaches the 300 result capacity the oldest test results will be deleted so that new test results can 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 45: ... animation before the most recent reading is displayed again 3 Turning Off Your Meter The meter will turn off automati cally time out 30 seconds after the last button press Important Cleaning and Disinfection Procedures 11 CHAPTER When using your meter avoid getting dirt dust blood control solution water or any other foreign substance into the test strip port You should wash your hands thoroughly ...

Page 46: ...ncing device helps ensure that no infection is passed on when you or oth ers come in contact with the meter and lancing device The meter and lancing device should be cleaned with a separate wipe prior to each disinfection Cleaning and disinfecting your AgaMatrix Jazz Wireless 2 Meter and Lancing Device CAUTION Never immerse the meter or the body of the lancing device in water or any other liquid s...

Page 47: ...ecting wipes used simulates cleaning and disinfecting your meter once a week for 5 years What can you use to clean and disinfect your meter and lancing device See Table 1 for the suggested disinfecting wipe You should use wipes that are pre saturated with disinfectant Do not im merse your meter or body of the lancing device in any liquid solution If you suspect your meter is not working properly a...

Page 48: ...om 2 Minutes Active ingredient Quaternary ammonium chlorides and isopropanol How do you clean and disinfect your meter and lancing device 1 Before you disinfect your meter and lancing device clean the outside of the meter and lancing device with a disinfect ing wipe listed in the table above Wipe each side of your meter and lancing device with moder ate pressure 3 times using the following method ...

Page 49: ...method a Wipe up and down 3 times b Wipe left and right 3 times c Avoid getting disinfectant inside the test strip port 4 After 2 minutes of contact time let air dry You should wash your hands thoroughly with soap and water after handling the meter lancet lancing device and test strips If you require technical assistance regarding cleaning and disinfecting your AgaMatrix Jazz Wireless 2 Meter or l...

Page 50: ...es as soon as possible Use only CR2032 or DL2032 batteries DEAD BATTERY MESSAGE The batteries in your meter do not have enough power to activate your meter and perform a test batteries must be replaced 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...

Page 51: ... environmental regulations How to Replace the Batteries 1 Open Battery Door Make sure the meter is off Turn the meter so you are looking at the battery door Slide the battery door off the meter 2 Remove the Old Batteries To remove the used batteries use a non metallic tool 3 Install the New Batteries Install the new batteries with the positive sign facing up towards you ...

Page 52: ...error without wasting valuable test strips When you are presented with an error message check for possible problems related to each message listed in this chapter CAUTION In certain cases the meter may return an error code or provide an inaccurate result if it is being used near electrical equipment like a power generator CAUTION If you get repeated error messages and are expe riencing symptoms of...

Page 53: ...he meter has detected an irregularity with the sample 1 The test strip may be partially filled Retest using a new test strip Ensure that enough blood is applied to the test strip when retesting 2 The sample may not be blood or control solution Retest using a new test strip Ensure that the test site is clean prior to performing a blood glucose test or that the control solution bottle tip is wiped c...

Page 54: ...umber 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 1 This error may be caused by extremely high glucose If you are experiencing symptoms of hyperglycemia contact your healthcare professional immediately If this error code persists on retesting call Customer Service or co...

Page 55: ... this error code persists on retesting call Customer Service The phone number is printed on the back of your meter Error 7 Meter problems have occurred that are beyond your control Contact Customer Service for assistance The phone number is printed on the back of your meter Error 8 A problem has occurred related to the meter hardware Contact Customer Service for assistance The phone number is prin...

Page 56: ...strips 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 system operating temperature range of 50 F to 104 F 10 C to 40 C ACTIONS Move to an area with an ambient temperature range of 50 F to 104 F 10 C to 40 C and relative humidity range of 10 to 90 Wait for the meter and test strips to reach the new tempe...

Page 57: ...test strip from the meter s test strip port Reinsert the test strip with the black side up and the end of the test strip with contact bars inserted up into the meter s test strip port Ensure that the test strip is fully inserted 3 CAUSE Defective meter or defective test strips ACTION Call Customer Service The phone number is printed on the back of your meter 4 CAUSE Blood or foreign objects put in...

Page 58: ...eshooting Situation 3 Meter results are not syncing to the supported device 1 CAUSE The meter and supported device are not properly paired or were not initially synced ACTION See Chapter 5 to pair your meter with your supported 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 the supported device is turned...

Page 59: ...gn in to your account on both devices results will sync between the devices through the cloud Alternately you can turn off the Bluetooth on one device The results will then sync to your other supported device 6 CAUSE Pairing between the meter and the supported device is not functioning properly and needs to be repaired ACTION In the App find the page that lists your meter and swipe to forget your ...

Page 60: ...ported device Troubleshooting Situation 5 Meter does not appear in the App when adding a new meter 1 CAUSE The meter cannot be detected ACTION On your meter press and hold the Meter Button until the Bluetooth symbol appears The meter should appear in the list of available devices in the App 2 CAUSE Bluetooth on the supported device is turned off ACTION Go to the settings menu in your supported dev...

Page 61: ... meter each meter is identified by the serial number found under the meter battery door Ensure that the correct meter is selected Troubleshooting Situation 7 The time and date do not ap pear on blood glucose test results 1 CAUSE The meter is not paired with a supported device ACTION See Chapter 5 to pair your meter with your supported device The date and time will be set to the date and time on yo...

Page 62: ...ds Measurement Units mg dL Result Range 20 to 600 mg dL Hematocrit 20 to 60 Operating Relative Humidity Range 10 to 90 System Operating Temperature Range 50 F to 104 F 10 C to 40 C 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 me ter do not match the time and...

Page 63: ...use in the presence of flammable mixtures When disposing of your meter follow all local environmental regulations Electrical Safety and Standards 16 CHAPTER In locations where cell phone use is not permitted such as some hospitals and some healthcare professional offices the meter should be off The meter has been tested and found to be appropriate for use at home In most cases it should not interf...

Page 64: ...ollowing 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 FCC guidelines help ensure that the AgaMatrix Jazz Wireless 2 Meter will not affect the operation of other nearby electronic devices Additionally other electronic devices should not af fect the use of your meter T...

Page 65: ... range 80MHz to 2 5GHz at 3V m as specified in IEC 61000 4 3 Electromagnetic emissions requirements as per EN 61326 2 6 and IEC 60601 1 2 Its electromagnetic emission is therefore low The recommended wireless security measures include AES encryption Contains Transmitter Module FCC ID QOQBLE113 ...

Page 66: ... it has not been modified altered or mis used Under this warranty we will replace free of charge Your Meter if it is defective in material or workmanship In order to have Your Meter replaced under this warranty please call customer service No other warranties express or implied are made We will not be liable for any incidental or conse quential damages You may incur This warranty gives You specifi...

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