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Summary of Contents for WaveSense JAZZ

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Page 2: ... a code Insert a test strip and you are ready to test Pre Post Tagging After you test tag your reading with the mealtime Better organize your data and see how your test results change before and after meals Positive Feedback AgaMatrix WaveSense JAZZ will display a smiley face icon if your result is within the target range ...

Page 3: ...nufacturer AgaMatrix Inc 7C Raymond Avenue Salem NH 03079 USA 2005 2011 AgaMatrix Inc Meter Firmware 2004 2011 AgaMatrix Inc US and International Patents Pending All rights reserved All trademarks and copyrights are the property of their respective owners 8100 02301 Rev F MDSS GmbH Schiffgraben 41 30175 Hannover Germany ...

Page 4: ...Meter Performing a Control Solution Test How To Test Your Blood Glucose Level Testing on Your Palm or Forearm Data Management Features Viewing Individual Results Viewing 14 Day Statistics Viewing 14 30 and 90 Day Averages Viewing Pre Post Mealtime Averages and Glucose Variability Tracking Viewing 1 Month 2 Week and 3 Day Trend Graphs 1 2 3 4 5 6 7 8 9 10 10 1 10 2 10 3 10 4 10 5 CHAPTER PAGE 4 4 5...

Page 5: ...rms Setting Hyperglycaemic Warning Alarms Setting the Glucose Target Range Setting Alarms Errors and Troubleshooting Display Messages Batteries Caring For Your Meter and Lancing Device Meter Specifications Symbols 11 12 13 14 15 16 17 18 19 20 21 22 23 24 PAGE CHAPTER 41 41 42 43 45 46 47 49 51 55 59 62 62 64 TITLE ...

Page 6: ...nsive indi viduals or patients in shock Inaccurate low results may occur for individuals experiencing a hyperglycaemic hyperosmolar state with or without ketosis Critically ill patients should not be tested with blood glucose meters 2 Severe dehydration and excessive water loss may yield inaccurate results If you believe you are suffering from severe dehydration consult your healthcare professiona...

Page 7: ... with your blood glucose test and you have followed all instructions described in the AgaMatrix WaveSense JAZZ Owner s Guide follow your healthcare professional s recom mendations 8 Do not use test strips that are expired or appear to be damaged as they may return inaccurate results 9 Healthcare professionals should follow their institution s infection control protocols 10 Always follow your healt...

Page 8: ...e the AgaMatrix WaveSense JAZZ System for 1 The diagnosis of diabetes 2 Testing the glucose levels of neonates children under 4 weeks 3 Testing glucose levels of arterial or venous blood 4 Testing glucose from sites other than the fingertip palm at the base of the thumb or forearm Possible test sites The AgaMatrix WaveSense JAZZ System requires only 0 5 μL of blood to perform a glucose test For be...

Page 9: ...t 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 or medication exercising or 3 Your blood glucose results obtained from the palm at the base of the thumb or forearm are not consistent with the way you feel CAUTION Please read all the instructions provided ...

Page 10: ...strips properly IMPORTANT Use AgaMatrix WaveSense JAZZ Test Strips only once Contact Bars Insert this end facing up into the meter s test strip port Visual Fill Window The window will turn red when enough blood has been applied or blue when enough control solution has been applied Sample Area Apply blood or control solution to the tip of the test strip here AgaMatrix WaveSense JAZZ Blood Glucose M...

Page 11: ... in their original vial only never store them in another vial any other container or outside the vial 5 After removing an AgaMatrix WaveSense JAZZ Test Strip from the vial immediately close the vial cap tightly 6 With clean dry hands you may gently handle the AgaMatrix WaveSense JAZZ Test Strip when removing it from the vial or inserting it into the meter 7 Do not use AgaMatrix WaveSense JAZZ Test...

Page 12: ...tton Use the CHECK button to confirm an option or make a selection in a menu 3 UP Arrow Button Use the UP arrow button to scroll backward through options 4 DOWN Arrow Button Use the DOWN arrow button to scroll forward through options 5 BACKLIGHT Button Use the BACKLIGHT button to turn the backlight ON and OFF 6 Test Strip Port Insert the AgaMatrix WaveSense JAZZ Test Strip with the contact bars fa...

Page 13: ...nning low 4 Dead Battery Message Appears when battery 2 in your meter is dead 5 Temperature Symbol Appears when the meter is outside its operating temperature range of 10 C to 40 C 50 F to 104 F 6 Ketone Symbol Appears when your glucose test results are higher than 13 3 mmol L 7 Control Solution message Appears after you have performed a control solution test 8 Units of Measurement symbol Results ...

Page 14: ...2 1 2 3 Countdown The 1 2 and 3 symbols will appear during a glucose test 13 Graphing Area Areas of the dot matrix will appear during a test and when displaying graphs 14 Happy Face Symbol The happy face is displayed with glucose test results that fall within specific pre and post meal target ranges 15 Mealtime Tags The mealtime tags appear after a test is complete and will help categorize your re...

Page 15: ...g device 4 Release Button Fires the lancet 5 Lancet Lances the skin to produce a drop of blood 6 Lancet Cover Covers the lancet for safety 7 Lancing Device Cap Covers the lancet when in lancing device 8 Alternate Site Testing Cap An AST clear lancing device cap used for obtaining a blood sample on the palm at the base of the thumb or forearm 9 Lancet Holder Cup Holds the lancet into place inside t...

Page 16: ... HOW TO ACTIVATE THE METER AND ENTER MENU MODE 1 When your meter is deactivated press the CHECK but ton to enter the menu mode 2 Press the DOWN or UP arrow buttons to view the options MEM STATS AVG MEAL GRAPH TIME DATE TAG RANGE BEEP HYPO HYPER and ALARM To view alter any of these options or settings press the CHECK button HOW TO ACTIVATE THE METER AND VIEW INDIVIDUAL RESULTS 1 When your meter is ...

Page 17: ...ayed Press the DOWN or UP arrow buttons until the word MEAL appears in the lower part of the display Press the CHECK button again to see your mealtime averages 2 Press the DOWN or UP arrow buttons repeatedly to scroll through your Breakfast Lunch Dinner and Bedtime Averages HOW TO DEACTIVATE THE METER To deactivate the meter press and hold the CHECK for 2 seconds If the meter is inactive for 3 min...

Page 18: ... you do not start the test within 5 minutes the meter will be deactivated To reactivate your meter press the CHECK button or remove the unused AgaMatrix WaveSense JAZZ Test Strip and reinsert it into the meter 2 Meter Ready for Test The meter now displays the blood drop symbol and the word Fill The AgaMatrix WaveSense JAZZ System is now ready for you to apply control solution or blood Preparing Fo...

Page 19: ... 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 healthcare professional to do so Control solution should only be used for 90 days after first opening the bo...

Page 20: ...d water or any other liquid to control solution 4 Control solution tests should be performed within the system operating temperature range of 10 C to 40 C 50 F to 104 F How to perform a control solution test 1 Inserting an AgaMatrix WaveSense JAZZ Test Strip Insert a new AgaMatrix WaveSense JAZZ Test Strip into the meter The meter will be activated when the test strip is fully inserted 2 Meter Rea...

Page 21: ... if a test is performed with AgaMatrix Control Solution When control solution is applied the visual fill window on the AgaMatrix WaveSense JAZZ Test Strip turns blue Your meter will beep once indicating that you should remove the tip of the AgaMatrix WaveSense JAZZ Test Strip from the control solution sample On the meter display the droplet symbol fills The scrolling bar and 1 2 3 indicates that t...

Page 22: ...test result is stored in memory To deactivate the meter remove the used AgaMatrix WaveSense JAZZ Test Strip Dispose of used materials properly If your control solution test results are out of the range repeat the test If the results from the control solution tests continue to fall outside that range do not use the AgaMatrix WaveSense JAZZ System to test your blood glucose Call Customer Care IMPORT...

Page 23: ...o 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 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 blood glucose level ...

Page 24: ...reparing the AgaMatrix Lancing Device Use the gray cap for testing on a fingertip and the clear cap for testing on the palm at the base of the thumb or forearm Remove Lancing Device Cap Snap off the cap from the lancing device Insert New Lancet Insert a new AgaMatrix Lancet firmly into the lancet holder cup Pushing the lancet into the lancet holder cup may cock the device this is OK Twist the Lanc...

Page 25: ...d to fill the test strip 0 5 μL Cock the Handle Pull the cocking handle out until it clicks You may have already cocked the handle accidentally while inserting the lancet this is OK The lancing device is now ready for use 2 Insert an AgaMatrix WaveSense JAZZ Test Strip Insert a new AgaMatrix WaveSense JAZZ Test Strip into the strip port of the meter Make sure you insert the test strip with the con...

Page 26: ...lm or forearm please refer to chapter 9 Note Keep your hand warm or gently massage the site you are lancing to stimulate blood flow Lance Test Site Press the lancing device against the site to be lanced Press the release button Express Blood Drop When testing on a finger tip wipe away the first blood drop that appears using a clean tissue or paper towel Squeeze from the base of your finger up towa...

Page 27: ...lood on the top surface of the test strip The AgaMatrix WaveSense JAZZ Test Strip acts like a sponge and draws the blood into the test strip through the sample area The vi sual fill window of the AgaMatrix WaveSense JAZZ Test Strip will turn red This is the visual fill window DONOT PUTBLOODHERE Apply blood here The entire visual fill window will turn red WARNING If the visual fill window does not ...

Page 28: ...apply blood to the AgaMatrix WaveSense JAZZ Test Strip when the test strip is out of the meter 6 Do not put blood or foreign objects into the AgaMatrix WaveSense JAZZ test strip port Doing so may lead to system failure 7 Do not apply more blood after beep 8 Carefully read the test results on the display before making any treatment decisions Remove Test Strip from Blood Sample when you hear the bee...

Page 29: ...ults allows you to view averages before and after meals to see what effect food has on your blood glucose levels After your result appears a tag will flash on the display suggesting a mealtime tag Breakfast Post Breakfast Lunch Post Lunch Dinner Post Dinner and Night For example if you test at 12 30 the meter will flash the word POST LUNCH If the tag is incorrect you can change it by pressing the ...

Page 30: ...in the menu mode Tagging Values The AgaMatrix WaveSense JAZZ Meter suggests mealtime tagging values according to this chart Feedback Depending on the mealtime tag and your test result the meter will display positive feedback in the form of a happy face The happy face symbol is displayed with glucose test results that fall within specific pre and post meal target ranges Example of Mealtime Tag POST...

Page 31: ...dy used test strip Remove the Lancet When you have finished testing snap off the cap from the lancing device Be careful not to touch the lancet tip Place the lancet cover onto a hard even surface such as a tabletop with the open end facing up 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 handle the used lance...

Page 32: ... properly WARNING The lancing device and lancets should only be used by one person Never share lancing devices or lancets Used test strips lancets and lancing devices may be considered biohazardous or medical waste in your city or town Follow all local regulations for proper disposal ...

Page 33: ... or use a larger lancet to obtain enough whole blood to perform a test Consult your healthcare professional for a recommendation CAUTION To ensure accurate results wash your hands with warm soapy water and dry before every test Clean and make sure there is no grease oil or lotion on the test site Testing on Your Palm or Forearm 9 CHAPTER Follow Chapter 8 steps 1 2 to begin blood glucose testing Fo...

Page 34: ...nds before pressing the release button 4 Express Blood Drop After lancing hold the lancing device against your skin until a blood droplet forms Make sure the blood drop is large enough to completely fill the visual fill window of the test strip Pull the lancing device directly off your palm or forearm to ensure that you do not smear the blood drop Return to Chapter 8 step 4 to continue with testin...

Page 35: ...tatistics 14 30 and 90 Day Averages Pre Post Mealtime Averages and Glucose Variability Tracking 1 Month 2 Week 3 Day Trend Graphs How to access all data management features All past test results are accessed the same way The following instructions will explain how to get to the different types of data 1 When your meter is deactivated press the CHECK but ton to enter menu mode The word MEM is displ...

Page 36: ...ns The standard deviation is an expression of the variation of readings from the average reading The greater this value the more variation exists between individual readings and the average The standard deviation feature is a way to track your glucose variability 1 When your meter is deactivated press the CHECK button once to enter menu mode The word MEM is displayed 2 Press the CHECK button again...

Page 37: ...rs on the display 3 Press the CHECK button again to enter the statistics section Note To return to the menu press the CHECK button Viewing 14 30 and 90 Day Averages 10 3 1 When your meter is deactivated press the CHECK but ton once to enter menu mode The word MEM is displayed 2 Press the DOWN or UP arrow buttons until the word AVG appears on the display 3 Press the CHECK button again to enter the ...

Page 38: ... vary by time of day The pre post mealtime averages and standard deviations only include the first instance of a particular mealtime tag breakfast post breakfast lunch post lunch etc per day over the last 14 day period The second and subsequent tests marked with the same time tag on the same day are not included The standard deviation feature is a way to track your glucose variability Note Standar...

Page 39: ...erage 4 Press the DOWN arrow button The display now shows your post breakfast average 5 Press the DOWN arrow button The display now shows your lunch average 6 Press the DOWN arrow button The display now shows your post lunch average 7 Press the DOWN arrow button The display now shows your dinner average 8 Press the DOWN arrow button The display now shows your post dinner average 9 Press the DOWN a...

Page 40: ... trend graph Note Press the UP arrow button to scroll backwards When scrolling you will cycle through the Trend Graphs To return to the menu press the CHECK button 1 When your meter is deactivated press the CHECK button once to enter menu mode The word MEM is displayed 2 Press the DOWN or UP arrow but Note Press the UP arrow button to scroll backwards When scrolling you will cycle through the Pre ...

Page 41: ...al unit represents about 2 8 mmol L Themostrecent resultisontherightsideofthescreen Each bar represents a test result average from 1 day Each vertical unit represents about 2 8 mmol L Themostrecent resultisontherightsideofthescreen Days mmol L 16 7 13 9 11 1 8 3 5 6 2 8 Days mmol L 16 7 13 9 11 1 8 3 5 6 2 8 ...

Page 42: ...s about 2 8 mmol L Themostrecent resultisontherightsideofthescreen IMPORTANT Averages above 16 7 mmol L will not be represented in the trend graphs Any bars represented at 16 7 mmol L may represent a value higher than 16 7 mmol L Days mmol L 16 7 13 9 11 1 8 3 5 6 2 8 mmol L 16 7 13 9 11 1 8 3 5 6 2 8 0 ...

Page 43: ...d 3 Press the CHECK button to enter and edit the tag setting 4 Turn the tagging feature ON or OFF with the DOWN or UP arrow buttons Your selection will be highlighted by the blinking of the symbol Press the CHECK button to confirm your selection and return to the menu 1 When your meter is deactivated press the CHECK button once to enter menu mode The word MEM is displayed 2 Press the DOWN or UP ar...

Page 44: ...y from the test strip You will hear this sound if the volume is set to ON or OFF IMPORTANT Check the Time and Date settings before testing In order to properly use the meter it is important to ensure that the time and date are set correctly 1 When your meter is deactivated press the CHECK but ton once to enter menu mode The word MEM is displayed 2 Press the DOWN or UP arrow but tons until the word...

Page 45: ...k display option is indicated by a 12hr The 24 hour clock display option is indicated by a 24hr Your selection will be highlighted by the blink ing of the symbol Press the CHECK button to confirm your selection and continue on to the hour setting 4 Set the hour flashing with the DOWN or UP arrow buttons Press the CHECK but ton to confirm your selection and continue on to the minute setting 5 Set t...

Page 46: ... to confirm your selection and move on to the year setting 4 Set the year flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection and move on to the month setting 5 Set the month flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection 6 Set the day flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm yo...

Page 47: ...et the hypoglycaemic threshold flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection and return to the menu Setting Hypoglycaemic Warning Alarms 15 CHAPTER The Hypoglycaemic Warning Alarm alerts you when your glucose test results are below the hypoglycaemic threshold you have set The meter is pre set to a hypoglycaemic threshold of 3 9 mmol L Always consult yo...

Page 48: ...ton to confirm your selection and move on to the hyperglycaemic threshold setting 5 Set the hyperglycaemic threshold flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection and return to the menu The Hyperglycaemic Warning Alarm alerts you when your glucose test results are above the hyperglycaemic threshold you have set The meter is pre set to a hyperglycaemic ...

Page 49: ...ed thresholds before making changes within the glucose target range menu refer to chapters 15 16 for setting these alarms Note The glucose target range is limited by the values set for your hypoglycaemic and hyperglycaemic warning alarms Your meter will not allow you to select a number beyond these alarm settings even if the warning alarm is turned off For example If you want the pre meal target r...

Page 50: ... on to the upper limit pre meal setting 5 Set the upper limit of the pre meal glucose target range flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your se lection and continue on to the lower limit post meal setting 6 Set the lower limit of the post meal glucose target range flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection and...

Page 51: ...ssing any button 3 The alarms will not appear during menu and test modes If an alarm is set to sound or flash while using these modes it will alarm after the meter is deactivated CAUTION Follow your healthcare professional s recom mendations on when and how often to test your glucose How to set alarms 1 Enter MEM Mode When your meter is deactivated press the CHECK button once to enter menu mode Th...

Page 52: ... the hour flashing numbers with the DOWN or UP arrow buttons Accel erated change is possible by holding down the arrow buttons Press the CHECK button to confirm the hour and advance to the minutes Set the minute flashing numbers with the DOWN or UP arrow buttons Press the CHECK button to confirm the minutes and return to the MENU Mode Note The volume of an alarm will be affected by your meter s vo...

Page 53: ... error 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 or a comput er monitor If this is the case move the meter away from the source of electrical interference Error 1 Problems have occurred that are related to test strip use 1 If this message appears the moment the test strip is in se...

Page 54: ...rip is in poor condition 1 The test strip may have been improperly stored e g hot humid conditions or may be expired 2 The test strip may have been mishandled by vigorous bending or shaking 3 Parts of the test strip may have become covered in grease oil or lotion 4 The test strip port connector may be dirty Error 4 Unusual test strip problems have occurred that may be related to extreme conditions...

Page 55: ...on of cold operating temperature and high haematocrit levels Retest in a warmer location 2 If this error code persists on retesting consult your healthcare professional Error 7 Meter problems have occurred that are beyond your control Contact Customer Care for assistance Temp Icon Test was performed outside the system operating temperature range of 10 C to 40 C 50 F to 104 F Move to an area with a...

Page 56: ... been inserted upside down wrong end in or incompletely inserted into the meter ACTION Insert the AgaMatrix WaveSense JAZZ Test Strip with the black side up and the contact bars of the test strip in the meter Ensure that the test strip is fully inserted 4 CAUSE Defective meter or defective AgaMatrix WaveSense JAZZ Test Strips ACTION Call customer care 5 CAUSE Blood or foreign objects introduced in...

Page 57: ...ache or confusion follow your healthcare Display Messages 20 CHAPTER with a new AgaMatrix WaveSense JAZZ Test Strip If problem persists call Customer Care and have the test strip LOT number available located on the test strip vial 2 CAUSE Sample applied after meter times out and deactivates ACTION Repeat the test using a new AgaMatrix WaveSense JAZZ Test Strip Wait until you see the blood drop sym...

Page 58: ...e memory with time and date It will be included in averages as a value of 33 3 mmol L ACTIONS If you feel symptoms such as fatigue thirst exces sive urination or blurry vision follow your healthcare profes sional s recommendations If you get a Hi glucose test result but have no symptoms of high blood glucose then retest with a new AgaMatrix WaveSense JAZZ Test Strip If you still get a Hi glucose t...

Page 59: ...Follow your healthcare professional s recommendations TEMPERATURE MESSAGE Flashing message with double beep if volume is ON MEANING The test has been performed outside the operat ing temperature range ACTIONS Move to an area with an ambient temperature of 10 C to 40 C 50 F to 104 F Wait for the meter and test strips to reach the new temperature usually 10 20 minutes and retest LOW BATTERY MESSAGE ...

Page 60: ...CKLIGHT BATTERY Backlight flashes when user presses the BACKLIGHT button MEANING Battery 1 which powers the backlight is low ACTIONS If the backlight flashes when user presses the BACKLIGHT button battery 1 must be replaced If the backlight does not turn on battery 1 is dead and must be replaced Battery numbers are indicated by the numbers printed on the pull tabs ...

Page 61: ...2 When replacing bat tery 2 the time and date information may be lost after the battery is removed from the meter If this happens activate the meter after installing the new battery and it will prompt you to set the time and date Correct time and date settings are needed to get correct averages Removing the batteries does not affect the meter s memory or previously stored user settings such as tim...

Page 62: ... the used battery pull the appropriate tab to pop out the battery Install the new battery with the positive sign facing up towards you 4 Close Battery Door Angle the battery door back onto the meter and swing down until it snaps gently into place Make sure that the battery door is completely closed before using IMPORTANT When the meter is deactivated and you are replacing battery 2 the time and da...

Page 63: ...d M Day Month 1 Set the year flashing with the DOWN or UP arrow buttons Press the CHECK but ton to confirm your selection 2 Set the month flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection 3 Set the day flashing with the DOWN or UP arrow buttons Press the CHECK button to confirm your selection 4 Set the hour flashing with the DOWN or UP arrow buttons Press ...

Page 64: ...tside of the meter or the lancing device using a cloth dampened with mild detergent or mild soap If you wish to clean the lancing device cap only remove the cap wash it in warm water rinse well and dry CAUTION Never immerse the meter or the body of the lancing device in water or any other liquid solution Caring For Your Meter and Lancing Device 22 CHAPTER 5 Set the minute flashing with the DOWN or...

Page 65: ... Automatic Deactivation 3 minutes after last user action Size 4 6 cm x 8 3 cm x 2 0 cm 1 81 x 3 27 x 0 79 Weight 48 g including batteries Equipment not suitable for use in the presence of flammable mixtures This meter complies with the applicable standards for Electromagnetic Compatibility however it is not recommended that it be used in the presence of strong electromagnetic fields When using thi...

Page 66: ...owing symbols may appear on the equipment packages or in the documents Serial Number Manufacturer In Vitro Diagnostic Medical Device Batch Code Consult Instructions For Use Do Not Reuse Temperature Limitation Use By Catalogue Number ...

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