Page 1 OWNER’S GUIDE Dose Helper and blood glucose meter...
Page 2 Salem, NH 03079 USA Germany ©2019 AgaMatrix, Inc. All rights reserved. Device Firmware ©2015-2019 AgaMatrix, Inc. All trademarks and/or copyrights are the property of their respective owners. WaveSense Jazz and the Jazz logo are trademarks owned by AgaMatrix, Inc. DoseCoach is a registered trademark of Sanofi.
Page 3 Notes on your treatment plan Ask your healthcare professional to help you fill out this page – use it to record important information about your treatment plan. The information should also be recorded on your Quick Reference Guide (included in the box). Name: Your starting dose: Your usual dose time:...
Page 4: Table Of Contents
Section 3. USING YOUR BLOOD GLUCOSE METER Important safety information Important health-related information About the lancing device About the AgaMatrix WaveSense JAZZ test strips Getting the lancing device ready Measure your blood glucose Dispose of the lancet and the test strip...
Page 5 Multiple fasting Section 4. USING DOSE HELPER Important safety information Dose Helper general principles How Dose Helper suggests insulin doses Using Dose Helper for the first time Normal use of Dose Helper Getting dose suggestions again (if a dose suggestion is not possible) Section 5.
Page 6 Changing the usual tag times (fasting and meal times) Changing your user icon Changing the blood glucose (BG) limits Changing the volume Changing the language Changing the dose reminder Changing Dose Helper settings Changing the usual dose time Reviewing the “Fasting BG rules” Reviewing the “Hypo rules”...
Page 7 Blood Glucose Meter error messages Questions and answers on tagging a blood glucose reading “Seek guidance” messages and what to do Section 10. QUESTIONS AND ANSWERS ON DOSE HELPER General questions and answers on Dose Helper Sick days, travel or vacation, changes in diet or activity “Dose Helper unavailable”...
Page 8 This page has been left blank on purpose.
Page 9: Section 1. Key Information About Jazz™ Dosecoach
Section 1: KEY INFORMATION ABOUT JAZZ™ DOSECOACH ® This section gives you important safety information about your JAZZ™ DoseCoach ®...
Page 10: Introduction
Introduction This section gives you important safety information about your JAZZ™ DoseCoach ® It also gives you a summary of the key information that is explained in more detail throughout this owner’s guide. You should refer back to this section to remind yourself of this key information, to find definitions of key terms, or for descriptions of icons you will see on the screen.
Page 11: Jazz™ Dosecoach ® - Key Information
JAZZ™ DoseCoach – key information ® Read all of the instructions in this owner’s guide before using your JAZZ™ DoseCoach ® About JAZZ™ DoseCoach Before you start using JAZZ™ ® DoseCoach you must: JAZZ™ DoseCoach is for people with ® ®...
Page 12 How to care for and dispose of JAZZ™ Who to contact for help and further DoseCoach information ® • • All parts of the kit are considered If you have any questions about your ‘biohazardous’. This means JAZZ™ treatment, contact your healthcare DoseCoach and the lancing device professional.
Page 13: Key Terms Used In This Owner's Guide
• Blood Glucose Meter: the JAZZ™ • Strip vial: the container that the DoseCoach function that you use to AgaMatrix WaveSense JAZZ test strips ® measure your blood glucose level. are kept in. • Dose Helper: the JAZZ™ DoseCoach •...
Page 14 • Fasting blood glucose reading: • Hypoglycaemia (hypo): you might fasting blood glucose is measured get symptoms of hypoglycaemia if after sleeping and before breakfast, your blood glucose is too low (below when you have not eaten or had a 3.9 mmol/L).
Page 15: Icons And Symbols Used In This Owner's Guide
Icons and symbols used in this owner’s guide These pages contain descriptions of the blood glucose tag icons and other icons you will see on the JAZZ™ DoseCoach screen. ® Blood glucose icons Insulin dose icons Fasting tag. Insulin dose recorded. Before meal tag.
Page 16 Dose suggestion icons History icons Fasting blood glucose target Warning triangle (for low blood range. glucose readings or reported low blood glucose or hypo Shooting star on the dose saved symptoms). screen. The number of filled sections show the number Dose Helper.
Page 17 Screen type icons Menu icons Question screen. History. Information screen. Settings. Warning screen. Logbook. Fasting blood glucose history. Averages. Advanced history menu. Standard day. Other icons Battery icon showing the level of power left in the batteries.
Page 18: Dose Helper - Key Information
Dose Helper – key information About Dose Helper • Dose Helper is a tool built in to JAZZ™ Only use Dose Helper to suggest DoseCoach ® doses for the type of insulin your • It helps you self-adjust your insulin doctor or nurse has activated it for.
Page 19 Dose Helper works best if: Always run Dose Helper before you • take a dose. You measure your fasting blood • glucose every day. Use Dose Helper to save all doses you • You run Dose Helper and save the take.
Page 20 What to do if you cannot get a dose You make the decision on what dose suggestion you will take • • Dose Helper might not be able to give Dose Helper is a guide. It gives you a you a dose suggestion if it does not suggested dose.
Page 21 Tell Dose Helper about hypo symptoms If you change your daily routine, you or low blood glucose might need to take a different dose • • It is important to tell Dose Helper Dose Helper adjusts your dose based about any hypo symptoms, or low on past information.
Page 22 Do not Use Dose Helper once a day at Do not use Dose Helper if you your usual dose time. have gestational diabetes. Contact your doctor or nurse Do not use Dose Helper if if you are not sure what dose you do not take your insulin to take.
Page 23: Blood Glucose Meter - Key Information
• Use with AgaMatrix WaveSense It is used to measure the level of JAZZ test strips and AgaMatrix glucose in fresh, capillary whole control solution only. blood – this helps you to monitor the effectiveness of glycaemic control.
Page 24 Tagging your blood glucose readings >> See page 13 for descriptions of the • tag icons. A tag will be suggested based on the time of day you measure your blood >> glucose, your usual fasting time, and See page 50 for information on usual meal times.
Page 25 What to do if your blood glucose If you have hypo or hyper symptoms readings are high or low. that are not consistent with your blood If you get blood glucose readings glucose readings, follow your treatment below 3.9 mmol/L or above 13.3 mmol/L plan or contact your healthcare and you have hypo or hyper symptoms, professional right away.
Page 26 This page has been left blank on purpose.
Page 27: Section 2. Getting Started With Jazz™ Dosecoach
Section 2: GETTING STARTED WITH JAZZ™ DOSECOACH ® This section shows you how to get started with JAZZ™ DoseCoach ®...
Page 28: What Comes In The Box
Other box contents (not shown): • Carrying case. • This owner’s guide. • Quick reference guide. • Test strip insert • Registration card. • Prescription card. • 1 vial of 10 AgaMatrix AgaMatrix Log book. WaveSense JAZZ control test strips solution...
Page 29 Do not Store AgaMatrix WaveSense Do not use JAZZ™ DoseCoach ® JAZZ test strips in their original or any other items included in vial in a cool, dry place at 8°C the box if the box seal is broken to 30°C.
Page 30: Get To Know Jazz™ Dosecoach
Left and right soft information. keys : select Strip port: insert an options shown in the black band at the AgaMatrix WaveSense bottom of the screen. JAZZ test strip here (see page 50) Power/back button : press this button to turn on JAZZ™...
Page 31 Each time you turn on There are three possible start-up screens that might JAZZ™ DoseCoach , it be shown (see below). ® will perform a meter system check. Note: Your user icon may be different to the icon shown in the examples below. Do not use JAZZ™...
Page 32: The Main Menu
The main menu The main menu appears on the screen when JAZZ™ DoseCoach is turned on ® by pressing You will see a start-up screen for a few seconds before it appears. Date and time. Battery icon. User icon. History menu option. Settings menu option.
Page 33: Getting Started
Getting started Remember to read all of the instructions Set the language. in this owner’s guide • The first time you use Press to turn on before using your JAZZ™ JAZZ™ DoseCoach JAZZ™ DoseCoach ® ® DoseCoach ® you will be asked to Choose the set the language.
Page 34 Review navigation buttons. • Do not use JAZZ™ DoseCoach if any ® areas of the screen appear to be missing. • The first time you use JAZZ™ DoseCoach ® you will be shown how to use the navigation buttons. Press “Next” to go through all the screens.
Page 35 Read the welcome Select your user icon. message. The user icon helps you The user icons you can • Read the welcome identify your own JAZZ™ choose from are shown message the first DoseCoach and helps below. ® time you use JAZZ™ to prevent getting it DoseCoach .
Page 36 Do not Check your user icon is shown Do not use JAZZ™ DoseCoach ® each time you use JAZZ™ if you see a user icon that is DoseCoach not yours. ® Do not share your JAZZ™ DoseCoach or use someone ®...
Page 37 Press to go back to previous screens. Check the time and date. • Setting the correct If time and time and date is date are correct, press “Yes”. important for JAZZ™ DoseCoach ® If not, press • If the time and date “No”.
Page 38 Read the definition of • If you pressed “No”, • Fasting BG. Repeat this to set JAZZ™ DoseCoach month, day, hour and ® • Read the fasting will ask you to correct minutes. blood glucose the clock settings. “Save” the definition carefully.
Page 39 Press to go back to previous screens. So Dose Helper can suggest next insulin glargine doses, it needs to know your fasting blood glucose reading each day. It is important to understand what time you should set as your usual fasting time. Read the definition carefully before you set the fasting time: Fasting blood glucose is measured...
Page 40 Set your usual fasting time. • >> The usual fasting time See page 140 for sets the middle point changing the usual of a 6 hour fasting fasting time. window. Congratulations, >> See page 50 for • You can only tag your JAZZ™...
Page 41: Section 3. Using Your Blood Glucose Meter
Section 3: USING YOUR BLOOD GLUCOSE METER This section shows you how to measure your blood glucose using JAZZ™ DoseCoach ®...
Page 42: Important Safety Information
Important safety information Do not Only use JAZZ™ DoseCoach Do not use AgaMatrix ® within a temperature range of WaveSense JAZZ test strips 10°C to 40°C. after the expiry date or 180 days after first opening the Only use JAZZ™ DoseCoach ®...
Page 43: Important Health-Related Information
JAZZ™ DoseCoach does not require a ® calibration code. If you are critically ill do not Insert an AgaMatrix WaveSense JAZZ use the Blood Glucose Meter. test strip and you are ready to measure Inaccurate blood glucose readings your blood glucose.
Page 44 >> get results that fall below 3.9 mmol/L See page 177 for information on Blood Glucose Meter error messages. or rise above 13.3 mmol/L follow your treatment plan or contact your healthcare professional right away. Always follow your healthcare professional’s recommendations. If you have symptoms that are not consistent with your blood glucose readings and you have followed all instructions described in this...
Page 45: About The Lancing Device
About the lancing device The lancing device is a medical tool for Always use a new lancet, collecting capillary blood samples for placed into the lancing device glucose monitoring or other tests which directly before measuring your require one or two small drops of blood. blood glucose.
Page 46 (highest setting). the lancet for safety. Remove after inserting Release button: fires into the lancet holder. the lancet. Available lancets Lancet ejector: safely The following lancets can ejects the used lancet. be used with this device: • AgaMatrix lancets...
Page 47: About The Agamatrix Wavesense Jazz Test Strips
About the AgaMatrix WaveSense JAZZ test strips • Sample area: blood or The AgaMatrix WaveSense The front of the AgaMatrix WaveSense JAZZ test strips let you control solution should be measure your blood JAZZ test strip is black. applied to the tip of this...
Page 48: Getting The Lancing Device Ready
Getting the lancing device ready Wash your hands with Remove the cap. Insert a new lancet. soap and warm water. • • Twist the cap Load a new sterile Rinse and thoroughly off the lancing lancet directly into dry your hands. device by turning it the bottom of the counter-clockwise...
Page 49 Remove the lancet Put the cap of the cover. lancing device back on by turning it clockwise • While holding the until it is fully into lancet firmly, twist/ place. pull the lancet cover in a straight direction to remove. •...
Page 50 Set the lancing depth. • • The lancing device The 5 dots represent offers 5 depth settings the 5 levels of depth Select the skin settings, with the penetration depth largest dot (highest by sliding the depth setting) on the left selector to the desired progressing to the depth.
Page 51 Do not Cock the lancing device. Do not lance • Pull the cocking your finger handle out until it before JAZZ™ clicks. This will cock DoseCoach ® the lancing device. the test strips are ready to use.
Page 52: Measure Your Blood Glucose
(“use by”) on the fingertip fingertip you are your AgaMatrix (excluding thumb going to use. WaveSense JAZZ and index finger). test strips before Keep your hand you use them.
Page 53 Wash your hands carefully with soap and warm water to increase the circulation of the blood into the fingers. • • Make sure there is no Keep your hand warm grease, oil or lotion on or gently massage the the fingertip you are site you are lancing to going to use.
Page 54 Insert a new AgaMatrix WaveSense JAZZ test strip into the strip port. • • Insert the AgaMatrix If you do not apply WaveSense JAZZ test blood within 4 minutes strip with the black of inserting the side facing up. AgaMatrix WaveSense •...
Page 55 Use the lancing device. • • Hold the lancing Press the release device firmly against button to get a blood the side of the sample. fingertip, with the cap resting on the fingertip. • Note: the harder you press the lancing device against the finger the deeper the puncture.
Page 56 Do not Get blood sample. Do not squeeze • Squeeze from the directly around base of your finger up the lanced area. towards the tip, until a small drop of blood appears. • If you do not see enough blood, set a deeper lancing level and try again.
Page 57 Bring the AgaMatrix WaveSense JAZZ test strip to the drop of blood. • • The test strip fills from An animation will the tip. appear on the • The fill window of the screen while JAZZ™ test strip will turn red.
Page 58 Measure your blood Do not press the blood sample and that glucose again with test strip too you apply blood to the a new AgaMatrix hard against the tip of the test strip. WaveSense JAZZ test test site. If the problem continues...
Page 59 Press to go back to previous screens. Review the blood A tag is a description glucose reading. label that you add to blood glucose readings. • Review your blood glucose reading carefully. What is fasting blood glucose and why is it important? >>...
Page 60 Tagging a fasting blood glucose reading. When you measure your If it is a fasting reading, press “Yes”. blood glucose inside the 4-hour fasting window, If it is not a JAZZ™ DoseCoach ® fasting reading, press will ask you to confirm “No”.
Page 61 How to tag a blood glucose reading. • >> When you have fasting tag will not be See page 13 for measured your blood available and will be descriptions of the tag glucose and the greyed out. icons. reading is displayed, >>...
Page 62 Check saved tag. Remove the AgaMatrix If you choose the WaveSense JAZZ test wrong tag and the • Check that you saved strip. blood glucose reading the correct tag and is still shown on the • review the blood The JAZZ™...
Page 63: Dispose Of The Lancet And The Test Strip
Dispose of the lancet and the test strip Remove the cap. Used test strips, lancets and lancing • Twist the cap devices may present off the lancing a risk to the health device by turning it of humans, animals counter-clockwise or the environment while holding the (biohazardous medical...
Page 64 Dispose of the lancet and the test strip. Put the cap of the lancing device back on by turning it clockwise until it is fully into place. • container. Carefully re-cap the • used lancet. Be careful Do not dispose of the not to touch the lancing device.
Page 65: How To Interpret The Blood Glucose Reading Screen
How to interpret the blood glucose reading screen Blood glucose Message area: not all When you have measured reading: the large your blood glucose, the blood glucose readings blood glucose reading will numbers on the screen have messages. be shown on the screen. show the measured blood >>...
Page 66 33.3 mmol/L Orange is for High blood readings above glucose limit the high blood glucose limit. 10.0* mmol/L Yellow is for readings above Blue is for 10.0* mmol/L. General readings BG target between the limits lower general BG target and 10.0* mmol/L.
Page 67 Messages on the blood glucose reading screen High blood glucose In fasting blood glucose target Blood glucose readings over When your doctor 13.3 mmol/L may or nurse turns Dose mean high blood Helper on for you, they glucose levels will set your fasting (hyperglycaemia).
Page 68 Low blood glucose Blood glucose You might get symptoms of readings below hypoglycaemia if your blood glucose 3.9 mmol/L may is too low (below 3.9 mmol/L). mean low blood Common symptoms of glucose levels hypoglycaemia are: palpitations, (hypoglycaemia). sweating, hunger, dizziness, tingling, blurred vision, difficulty in thinking, >>...
Page 69 What to do if your blood glucose If you have hypo or hyper readings are high or low: symptoms that are not consistent with If you get blood glucose your blood glucose readings, follow readings below 3.9 mmol/L or above your treatment plan or contact your 13.3 mmol/L and you have hypo or healthcare professional right away.
Page 70: Tag Times
Tag times This screen will appear the first time you tag a Check the tag times. before meal or after meal If the tag reading. times are correct, press • Check if the times are “Yes”. correct for your eating habits.
Page 71: Fasting Check
Fasting check Press to go back to previous screens. This screen will appear: • If you are tagging a Check if this is really a Fasting blood glucose fasting blood glucose fasting blood glucose is measured after reading for the first reading.
Page 72: Multiple Fasting
Multiple fasting This screen will appear if you have tagged more Select the correct than one fasting blood fasting reading. glucose reading and need Choose the fasting to choose one for Dose blood glucose Helper to use. reading to be used for Dose Helper.
Page 73: Section 4. Using Dose Helper
Section 4: USING DOSE HELPER This section shows you how to use your Dose Helper to help you adjust your insulin glargine dose. Dose Helper needs to be set up for you by your doctor or nurse.
Page 74: Important Safety Information
Important safety information Read all of this section before If your doctor or nurse told you using Dose Helper. If you do to take your once-daily insulin not follow these instructions, glargine dose in the morning, you may get too much or too measure your fasting blood little insulin glargine –...
Page 75 be able to give a dose If you are not sure Dose Helper might not suggestion. about what dose to always be able to give take, talk to your you a dose suggestion. Only use Dose Helper doctor or nurse. For example, because: to suggest doses for the type of insulin your...
Page 76: Dose Helper General Principles
Dose Helper general principles Dose Helper is only available to help with the adjustment of your insulin glargine dose if your doctor or nurse has turned it on for you. Dose Helper can help you adjust your insulin glargine dose to get your fasting blood glucose (fasting BG) to the fasting blood glucose target range set by your doctor or...
Page 77 When you reach your fasting blood glucose target range, you can still use Dose Helper to help you adjust your dose to keep your fasting blood glucose in your fasting blood glucose target range. • The suggested dose is meant for you only. Do glucose is above your fasting blood glucose not share your JAZZ™...
Page 78: How Dose Helper Suggests Insulin Doses
How Dose Helper suggests insulin doses Required information Dose Helper works best if: • You measure your fasting blood Dose Helper needs your fasting blood glucose every day. glucose (fasting BG) readings. It can • You run Dose Helper and save the only use these if you also entered amount of insulin glargine that you your previous insulin dose.
Page 79 To give a dose suggestion, Dose Helper needs three fasting blood glucose readings from the last three days, and that you took a consistent dose each day.
Page 80 Calculations Dose Helper may suggest dose increases Dose Helper helps you adjust your every three days if: insulin glargine dose based on past • Two of the last three fasting blood information. It cannot plan ahead glucose readings are above your for sudden changes, for example: fasting blood glucose target range.
Page 81: Using Dose Helper For The First Time
Using Dose Helper for the first time Start using Dose Helper when it is time for you to take your dose. Before you start using Dose Helper Dose Helper needs three fasting blood you need to know: glucose readings from the next three •...
Page 82 Run Dose Helper. >> When it is time for your If you get a message dose, press to start on the screen after Dose Helper. pressing the Dose Helper button, see page • The first time you run 187 for questions and Dose Helper you will answers on using Dose be told about the Dose...
Page 83 Press to go back to previous screens. Dose Helper menu. >> The Dose Helper menu See page 133, for appears on the screen how to change the Dose each time you run Dose Helper settings. Helper by pressing Choose “Take a dose”.
Page 84 Press to go back to previous screens. Read the user agreement. Read the welcome message. • Read to the end. Dose Helper will only • work if you confirm This shows the next Then the user agreement. steps you will go “Confirm”...
Page 85 Read the hypo The most common Correctly reporting definition. hypo symptoms are: any hypo symptoms Palpitations, sweating, or low blood glucose Then go to hunger, dizziness, readings is important the “Next” screen. tingling, blurred vision, to get correct dose difficulty in thinking, suggestions.
Page 86 Answer the hypo questions. • If you pressed “Yes”, If you have not had any low blood you will be asked glucose readings or hypo another hypo question symptoms in the last to find out how bad day(s), press “No”. your hypo was.
Page 87 Read the previous So that Dose Helper dose message. can provide dose suggestions, all The first time you run previous doses must Dose Helper you do be recorded. not need to enter any previous doses. Press “OK”.
Page 88 Press to go back to previous screens. Read about how to get a dose suggestion. Decide whether to take a dose. • • Dose Helper needs Therefore, follow the three fasting blood instructions on the If you will glucose readings from screen every day for take a dose now, press “Yes”.
Page 89 Decide what dose to take. Remember that you have to use Dose • Enter the insulin Until you enter an Helper every day, for glargine dose that insulin glargine dose, at least three days “Next” will be grey you will take now (as before Dose Helper advised by your doctor and you cannot go on.
Page 90 Press to go back to previous screens. Check the dose. Take your insulin glargine dose. • Check that you will • save the correct Take your insulin dose. glargine dose immediately after “Save” the you have saved dose. your dose on JAZZ™ DoseCoach ®...
Page 91 Exit Dose Helper. • >> Doses not suggested See page 76 for by Dose Helper have a more information about grey background. the shooting star. • The number of filled sections on the shooting star shows the number of pairs (dose + fasting blood glucose) you have collected.
Page 92: Normal Use Of Dose Helper
Normal use of Dose Helper This section explains the steps for when you use Run Dose Helper Dose Helper every day and When it is time for your Dose Helper has enough dose, press to start information to make dose Dose Helper.
Page 93 Dose Helper menu. >> The Dose Helper menu See page 147 for appears on the screen how to change the Dose each time you run Dose Helper settings. Helper by pressing Choose “Take a dose”. Then go to the “Select” screen. Or press “Exit”...
Page 94 Press to go back to previous screens. Answer the hypo questions. • If you pressed “Yes”, If you have not had any low blood you will be asked glucose readings another hypo question (on another blood to find out how bad glucose meter) or hypo your hypo was.
Page 95 The most common hypo symptoms are: Palpitations, sweating, hunger, dizziness, tingling, blurred vision, difficulty in thinking, faintness, anxiety. These symptoms may vary and you may have other symptoms. Contact your healthcare professional for more details.
Page 96 Answer the previous dose question. • If you pressed “Yes”, If you have not taken any dose of insulin you will be asked to glargine since the last enter the dose. saved dose, press “No”. Enter the dose date. If you have, press “Yes”.
Page 97 • >> Repeat this to enter If you get a message the dose time and on the screen after dose amount. answering this question, see page 187 for If you are not questions and answers sure what dose you took, on using Dose Helper.
Page 98 Decide what dose to take. • Read the suggestion If you will take Enter the insulin for your insulin a different dose, press glargine dose that “Change”. glargine dose carefully. you will take now. • Find out more If you pressed Go to the “Change”, you will “Next”...
Page 99 Check the dose. Take your insulin glargine dose. • Check that you will • save the correct Take your insulin dose. glargine dose immediately after “Save” the you have saved dose. your dose on JAZZ™ DoseCoach ® • For details about taking insulin glargine, please read the instructions...
Page 100 Exit Dose Helper. • >> Dose suggestions from Turn JAZZ™ See page 76 for “Off”. Dose Helper have a DoseCoach more information about ® blue background. the shooting star. Or press • Doses not suggested “Menu”. by Dose Helper (i.e., doses entered manually) have a grey background.
Page 101: Getting Dose Suggestions Again (If A Dose Suggestion Is Not Possible)
Getting dose suggestions again (if a dose suggestion is not possible) Dose Helper might not be able to give Dose Helper needs three fasting blood you a dose suggestion if it does not have glucose readings from the last three enough information.
Page 102 Run Dose Helper When it is time for your dose, press to start Dose Helper. • Check the user icon on the start-up screen. • Never use a JAZZ™ DoseCoach that is ® not yours. >> If you get a message on the screen after pressing the Dose Helper button,...
Page 103 Press to go back to previous screens. Dose Helper menu. • >> The Dose Helper See page 147 for menu appears on the how to change the Dose screen each time you Helper settings. run Dose Helper by pressing Choose “Take a dose”.
Page 104 Read the warning message. • >> • The warning message To find out about Therefore, follow the will explain why a dose Dose Helper warning instructions on the suggestion cannot be messages, see screen every day for made. page 187 for questions the next three days.
Page 105 If you are not sure Decide whether to take a dose. about what dose to • • Check if it is time for Always record your take, contact a doctor your dose and you insulin glargine dose or nurse. know what dose to in Dose Helper.
Page 106 Press to go back to previous screens. Decide what dose to Check the dose. Take your insulin take. glargine dose. • Check that you will • Enter the insulin save the correct Take your insulin glargine dose that dose. glargine dose you will take now.
Page 107 Exit Dose Helper. • Doses not suggested Turn JAZZ™ “Off”. by Dose Helper have a DoseCoach ® grey background. Or press • The number of filled “Menu”. sections on the >> shooting star shows See page 76 for the number of pairs more information about (dose + fasting blood the shooting star.
Page 108 This page has been left blank on purpose.
Page 109: Section 5. Reviewing Your History Data
Section 5: REVIEWING YOUR HISTORY DATA JAZZ™ DoseCoach keeps your blood glucose readings ® and other information you enter. You can view this data on graphs and tables in the history. This section shows you how to read your history data.
Page 110: About Your History Data
About your history data There are four options in the “History” menu: • Logbook: lists your blood glucose readings and insulin glargine doses with time and date. • Fasting BG: three graphs that show your fasting blood glucose (fasting BG) readings and insulin glargine doses over the last 3 days, 7 days and 6 weeks.
Page 111 Press to go back to previous screens. There are two options in the “Advanced” history menu: • Standard day: this graph shows your before meal and after meal blood glucose readings (breakfast, lunch, dinner) for the last 7, 14 and 30 days, grouped by their tag.
Page 112 Accessing the “History” menu: Press to go back to previous screens. Press to turn on Select “History”. JAZZ™ DoseCoach ® Choose “History”. • Check the user icon on the start-up Then press screen. “Select”. • Never use a JAZZ™ DoseCoach that is ®...
Page 113 Select an option. Choose an option. Then press “Select”. More information about the “History” menu options is included on the following pages.
Page 114: Logbook
Logbook About the “Logbook” Date: any blood glucose readings and insulin glargine doses are shown below the date they were saved on. More information: use to show more information. >> See page 13 for a list of all blood glucose icons.
Page 115 Press to go back to previous screens. Blood glucose Insulin doses readings This example shows a This example shows blood glucose reading an insulin glargine entry. dose entry. Time: time of the Time: time of the blood glucose reading. insulin glargine dose. Tag icon: shows Insulin dose icon: the tag selected for...
Page 116 Clock changes High blood glucose readings This example shows a This example shows clock change entry. a high blood glucose reading entry. • You will see this • when the time or Blood glucose date on JAZZ™ readings above your DoseCoach high blood glucose ®...
Page 117 Low blood glucose Hypo symptoms readings This example shows This example shows a low blood glucose an entry of reported reading entry. low blood glucose or hypo symptoms. • Blood glucose • readings below your On days where you low blood glucose had a low blood limit are shown with glucose reading...
Page 118 Severe hypo symptoms • This example shows On days where an entry of reported you had a very low blood glucose low blood glucose less than 3.1 mmol/L reading or you or severe hypo reported very low symptoms. blood glucose (below 3.1 mmol/L) or severe hypo symptoms in Dose...
Page 119 This page has been left blank on purpose.
Page 120: Fasting Blood Glucose (Fasting Bg)
Fasting blood glucose (Fasting BG) About “Fasting BG” history “3 days” shows your “7 days” shows your “6 weeks (averages)” fasting blood glucose fasting blood glucose shows weekly averages of readings and insulin readings and insulin your fasting blood glucose glargine doses for the last glargine doses for the last readings and of your...
Page 121 Press to go back to previous screens. Press to move between the three graphs. Colored bubbles or squares: show Green area: shows your fasting your fasting blood glucose readings for blood glucose target range if Dose a day or average fasting blood glucose Helper is turned on.
Page 122 Press to go back to previous screens. Hypo triangle • • On days where you The number in the had a low blood triangle is the number glucose reading or of days within that you reported low week with a low blood blood glucose (below glucose reading, 3.9 mmol/L) or hypo...
Page 123 High blood glucose readings above 20.1 mmol/L • Blood glucose readings above 20.1 mmol/L are marked with an orange circle on the graph and are shown at the same vertical position. >> See page 63 for the different color ranges.
Page 124 Multiple doses in one day • If you see on a graph, it means that more than one insulin glargine dose was saved that day. Only use Dose Helper if you take insulin glargine once daily.
Page 125 Dose unknown • If you see on a graph, it means you confirmed that you took an insulin glargine dose but that you were unsure about the amount of insulin glargine you took.
Page 126 Clock change If you see a zig-zag line on a graph, it means that the time or date was changed. The start of the date range is not shown if there has been a time or date change. Changing the time or date can affect Dose Helper.
Page 127: Averages
Averages Press to go back to previous screens. About “Averages” Number of days: the Standard deviation number of recent days (±SD) of all blood glucose included in the calculations readings or readings with for averages and standard the same tag. deviation.
Page 128 • The averages, standard are not included in averages, standard deviations and trend graphs are calculated deviations and trend using the average of all graphs. • blood glucose readings Missing dose values and all doses within the are not included in given time period (7, 14, averages, standard 30 or 90 days).
Page 129: Standard Day
Standard day Press to go back to previous screens. About the “Standard day” graph The Standard day graph to dinner then before bed. is accessed from the For each meal, the before “Advanced” history meal and after meal menu. readings are shown in separate columns.
Page 130 Orange line: shows your high blood glucose limit. Grey dots: show your blood glucose readings. • When readings overlap, the dots appear darker. Red line: shows your low blood glucose limit. Before meal tag. After meal tag. Meal name.
Page 131: Dose Helper History
Dose Helper history Press to go back to previous screens. The Dose Helper history is accessed from the “Advanced” history menu. About “Dose Helper” History Suggested dose The Dose Helper history shows the (from Dose Helper). suggested dose and Taken (saved) the taken (saved) dose dose.
Page 132 Press to go back to previous screens. Changed doses Unknown taken doses If the taken dose means you was different to the confirmed that suggested dose, it will you took an insulin be shown in black, as glargine dose but in this example.
Page 133 Missing dose Dose suggestion not suggestions possible The empty box shows icon means you did not get a dose that a dose suggestion suggestion from Dose was not possible that Helper that day. day. For example, Dose Helper did not have enough data to suggest a dose.
Page 134 Clock changes This example shows a clock change entry in the “Dose Helper” history. Changing the time or date can affect Dose Helper. >> See page 198 for more details.
Page 135: Section 6. Changing The Jazz™ Dosecoach ® Settings
Section 6: CHANGING THE JAZZ™ DOSECOACH ® SETTINGS If you need further help after reading these instructions, please contact your healthcare professional, or call customer service at 0800 093 1812.
Page 136: Accessing The Settings Menu
Accessing the settings menu Press to turn on Select “Settings”. JAZZ™ DoseCoach ® Choose “Settings” • Check the user icon on the start-up Then press screen. “Select”. • Never use a JAZZ™ DoseCoach that is ® not yours.
Page 137 Press to go back to previous screens. Select an option. Choose an option. There are eight options in the “Settings” menu: Then press “Select”. • Clock. • These settings are Tagging. • described in more detail User icon. • on the following pages. BG limits.
Page 138: The Clock Setting Menu
The clock setting menu There are four options in the “Clock” menu: Changes to the time or date may affect Dose • Time: the current time Choose an option. Helper. will be shown. • Date: the current date Check the information Press “Select”...
Page 139: Changing The Time Or Date
Changing the Time or Date Read the message. Set the time and date. • “Save” the If this message does Set the correct year. not appear, go to clock changes at the last Step 2. setting step. Go to the Press “OK”. “Next”...
Page 140: Changing The Time Format
Changing the time format Changing the date format Set the time format. Set the date format. Choose an option. Choose an option. • • 24 hour (e.g. 13:00) or day-month-year (e.g. • 12 hour (e.g. 1:00pm). 26 March, 2019) or •...
Page 141 Changing the usual tag times (fasting and meal times) What is fasting blood glucose and why is it important? Fasting blood glucose are fasting. Telling hours after your usual readings: Fasting blood JAZZ™ DoseCoach fasting time. ® • glucose is measured which blood glucose If you adjust the after sleeping and before...
Page 142 Changing the usual tag times (fasting and meal times) A tag is a description label that you add to The different shaded blocks show the tags that blood glucose readings. JAZZ™ DoseCoach will suggest across the day. ® These are based on the usual fasting time and usual meal times that you can change in the settings.
Page 143 Note: These are Before meal tags will be suggested between two example values and hours before a meal time to one hour after a may not reflect your meal time. In this example, before lunch tags will treatment plan. be suggested from 10:30 to 13:30. Usual lunch time Usual dinner time time (here 12:30)
Page 144 Press to go back to previous screens. Select the usual tag Set the usual time. time you would like to Change the change. selected tag time. Choose an “Save” your option. changes. Then press Or press “Select”. “Cancel”.
Page 145 Changing your user icon Set your user icon. • You must check the Choose your user user icon on the icon. start-up screen each “Save” your time you turn JAZZ™ changes. DoseCoach ® • Never use a JAZZ™ Or press “Cancel”.
Page 146 Changing the blood glucose (BG) limits Select the BG limit you Set the BG limit. If Dose Helper is would like to change. turned off, you can Change the blood set your “High BG”, Choose an glucose (BG) limits. “General BG target” option.
Page 147 Changing the volume Changing the language Set the volume. Set the language. Change the Choose an volume. option. “Save” your “Save” your changes. changes. Or press Or press “Cancel”. “Cancel”.
Page 148 Changing the dose reminder If the dose reminder option is turned on by Set the dose reminder. your doctor or nurse, Choose when JAZZ™ DoseCoach will ® you would like to remind you when your be reminded to take dose of insulin glargine is your dose.
Page 149 Changing Dose Helper settings Dose Helper settings. • Fasting BG rules: You can access the Dose Choose an Helper settings through you can view these option. the JAZZ™ DoseCoach but only your doctor ® Then press settings menu, or or nurse can change “Select”.
Page 150 Changing the usual dose time Read the message. Set the usual dose time. Changes to dose time may affect Dose • If this message does Dose Helper can be run Helper. Ask your not appear, go to three hours either side doctor or nurse what Step 2.
Page 151 Reviewing the “Fasting BG rules” • These rules describe how Dose Helper calculates a dose increase or decrease suggestion based on your fasting blood glucose (fasting BG or FBG). • You can view these rules but only your doctor or nurse can change them.
Page 152 Reviewing the “Hypo rules” • These rules describe how Dose Helper calculates a dose decrease suggestion if you report low blood glucose (below 3.9 or 3.1 mmol/L), or hypo symptoms. • You can view these rules but only your doctor or nurse can change them.
Page 153 Reviewing the user agreement Read the message. In the user agreement you can check the type Read the rest of of insulin Dose Helper the user agreement. can be used with.
Page 154 Turning Dose Helper off Read the message. Only your doctor or nurse can turn Dose If you want Helper back on. to turn Dose Helper off now, press “Yes”. If you do not want to turn Dose Helper off, press “No”.
Page 155 Section 7: MAINTAINING YOUR JAZZ™ DOSECOACH ® If you need further help after reading these instructions, please contact your healthcare professional, or call customer service at 0800 093 1812.
Page 156 Performing a control solution test The control solution is used to: • Make sure that the AgaMatrix WaveSense JAZZ test strips work with Control solution should only JAZZ™ DoseCoach ® be used for 90 days after first • Practice measuring without having to opening the bottle or until the use your own blood.
Page 157 Insert a new AgaMatrix WaveSense JAZZ test strip into the strip port. • • Wash your hands If you do not apply with soap and warm control solution within water. Rinse and dry 4 minutes of inserting thoroughly before the test strip, JAZZ™...
Page 158 Prepare the AgaMatrix control solution. • • JAZZ™ DoseCoach Put a drop of control ® has two different solution on a tissue levels of control then throw the tissue solution: away. Wipe the tip - normal or of the bottle using a - high.
Page 159 Apply the AgaMatrix control solution. • • Put a second drop JAZZ™ DoseCoach ® of AgaMatrix control will beep once to tell solution on a clean you when you surface such as a should remove plastic bag. the tip of the •...
Page 160 JAZZ™ DoseCoach ® calculating your test result. If the fill window on the AgaMatrix WaveSense JAZZ test strip does not completely fill, you may get an inaccurate test result. Test again with a new test strip and make sure the fill window is completely full.
Page 161 View control solution test results. Results from control solution tests do not • • The results of the Make sure you look at give you information control solution the control solution about your blood test will be shown level (normal or high) glucose level.
Page 162 Control solution checks If the results from the control Out of range test results may be due to: solution tests continue to be • Out of date or faulty control solution. out of range, do not use JAZZ™ • Out of date or faulty test strip. DoseCoach to test your blood ®...
Page 163 Important disinfection procedures • When using JAZZ™ DoseCoach ® avoid getting dirt, dust, blood, control solution, water, or any other liquid Be careful when cleaning inside the test strip port, battery and disinfecting JAZZ™ compartment and mini-USB port. DoseCoach ® •...
Page 164 Cleaning and disinfecting JAZZ™ DoseCoach and the lancing device ® See the table below for the validated disinfecting wipe. Other brands of wipes have not been tested and may cause cosmetic damage to JAZZ™ DoseCoach and the ® lancing device. Brand Name Manufacturer Available at...
Page 165 Pre-clean. • Make sure JAZZ™ and the lancing device DoseCoach is turned with a disinfecting ® off. wipe. • Before you clean and disinfect JAZZ™ DoseCoach and the ® lancing device, pre clean the outside of JAZZ™ DoseCoach ®...
Page 166 Clean and disinfect with a new wipe. Avoid getting disinfectant inside the test strip port and the mini-USB port. • • Use a new disinfecting Wipe each side of wipe listed in the table JAZZ™ DoseCoach ® on page 162. and the lancing •...
Page 167 Let the disinfectant take effect. If you have any questions about • Wash your hands cleaning and thoroughly with disinfecting JAZZ™ soap and water after DoseCoach or the ® handling JAZZ™ lancing device, call DoseCoach , the ® customer service at lancet, lancing device 0800 093 1812 and test strips.
Page 168 If you suspect JAZZ™ DoseCoach Stop using JAZZ™ DoseCoach ® ® not working properly after cleaning the lancing device after cleaning and and disinfecting, check that your disinfecting in the following cases: system is working properly by • If you notice any signs of performing a control solution test.
Page 169 Looking after JAZZ™ DoseCoach ® • To help stop JAZZ™ DoseCoach from ® getting damaged, always keep it in If you think JAZZ™ the carrying case when you are not DoseCoach may be ® using it. damaged, do not use it. •...
Page 170 Changing your JAZZ™ DoseCoach batteries ® Remove the battery door. Change the batteries. • • JAZZ™ DoseCoach DoseCoach to lose To remove the used ® ® comes with two the clock time. primary (non- • primary (non- Slide open the battery rechargable) AA rechargable) AA door on the back of...
Page 171 Only use AA lithium batteries in your JAZZ™ DoseCoach ® Discard batteries according to your local environmental regulations. >> See page 170 for discarding batteries.
Page 172 Discarding your JAZZ™ DoseCoach and batteries ® • JAZZ™ DoseCoach ® an electronic device. Remove the coin cell battery before discarding. When you discard • Slide open the battery JAZZ™ DoseCoach ® door on the back of you should follow all JAZZ™...
Page 173 Section 8: QUESTIONS AND ANSWERS ON JAZZ™ DOSECOACH ® If you need further help after reading these instructions, please contact your healthcare professional, or call customer service at 0800 093 1812.
Page 174 General questions and answers on JAZZ™ DoseCoach ® What happened What this could mean and what to do JAZZ™ DoseCoach The JAZZ™ DoseCoach batteries have insufficient power. ® ® does not turn on Change the batteries (see page 168). OR: The JAZZ™ DoseCoach when you press batteries are not installed ®...
Page 175 What happened What this could mean and what to do The history shows You may have just started using JAZZ™ DoseCoach ® no information. have not collected enough information. Measure your blood glucose and use Dose Helper (if turned on). The history will fill automatically.
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Page 177 Section 9: BLOOD GLUCOSE METER MESSAGES If you need further help after reading these instructions, please contact your healthcare professional, or call customer service at 0800 093 1812.
Page 178 Check both batteries mode after inserting are installed correctly or replace the batteries (see an AgaMatrix page 168). OR: The test strip has not been inserted fully, or has been WaveSense JAZZ test strip.
Page 179: Blood Glucose Meter Error Messages
Blood Glucose Meter error messages JAZZ™ DoseCoach might show error ® messages after you have measured your In certain cases, JAZZ™ DoseCoach ® blood glucose, or warning messages may return an error code or provide about your insulin treatment. an inaccurate blood glucose reading This section gives information about the if it is being used near electrical Blood Glucose Meter error messages.
Page 180 Error messages and what to do If this message appears the moment the test strip is inserted, the test strip may be wet or damaged. Measure your blood glucose with a new test strip (see page 50). OR: If this message appears during a test, the test strip may have been removed too early.
Page 181 Error messages and what to do The test strip may be partially filled. You should check the window of the test strip to make sure that it is full. Measure your blood glucose again with a new test strip. Ensure that enough whole blood is applied to the test strip when measuring again (see page 50).
Page 182 Error messages and what to do The test strip may have been improperly stored (for example, in hot or humid conditions) or may have expired. Check the test strip vial for the expiry date. Do not use test strips after the expiry date or 180 days after first opening the vial.
Page 183 Error messages and what to do The meter was unable to produce a result or unusual test strip problems have occurred that may be related to extreme conditions. This error may be caused by extremely high blood glucose. If you have symptoms of hyperglycaemia, contact your healthcare professional right away.
Page 184 Error messages and what to do This may be caused by a combination of cold operating temperature and high haematocrit levels. Measure your blood glucose again in a warmer location. OR: If this error code persists on measuring again, call customer service at 0800 093 1812.
Page 185 Error messages and what to do A problem has occurred related to the meter hardware. This may be caused by connecting a mini-USB cable to the meter while testing. Disconnect the cable and measure your blood glucose again. OR: If this error code persists on measuring again, call customer service at 0800 093 1812.
Page 186: Questions And Answers On Tagging A Blood Glucose Reading
Questions and answers on tagging a blood glucose reading What is fasting blood glucose and why is it important? Fasting blood glucose readings: Fasting blood glucose is measured after sleeping and before breakfast, when you have not eaten or had a drink containing sugar/glucose for at least 8 hours.
Page 187 What happened What this means and what to do The fasting blood You can only use the fasting tag within three hours either glucose tag is side of your usual fasting time. not available (greyed out). Check if this is really a fasting blood glucose reading. If not, choose a different tag.
Page 188: Seek Guidance" Messages And What To Do
“Seek guidance” messages and what to do What happened What this means and what to do You had a blood glucose (BG) reading less than 3.1 mmol/L. Contact your healthcare professional before your next dose - they may want to adjust your treatment plan. You had three or more hypos or low blood glucose readings in the last three weeks.
Page 189: Section 10. Questions And Answers On Dose Helper
Section 10: QUESTIONS AND ANSWERS ON DOSE HELPER If you need further help after reading these instructions, please contact your doctor or nurse, or call customer service at 0800 093 1812.
Page 190: General Questions And Answers On Dose Helper
General questions and answers on Dose Helper What happened What this means and what to do You forgot to take If you are not sure about what to do or what dose to your dose (and take, contact your doctor or nurse. did not run Dose Helper).
Page 191 What happened What this means and what to do You ran Dose Helper If you are not sure about what to do or what dose to and saved the dose, take, contact your doctor or nurse. but you forgot to take the suggested If you will take a dose now, run Dose Helper to dose.
Page 192 What happened What this means and what to do You took a dose Run Dose Helper when it’s time for your next insulin without running glargine dose. You will be able to enter any recent doses Dose Helper. at this time by answering the previous dose question (see page 94).
Page 193 What happened What this means and what to do Dose reminder went The dose reminder goes off if you have not used off but you already Dose Helper to save a dose by then. took your dose. • If you already took your dose but did not use Dose Helper, do not run Dose Helper now.
Page 194 What happened What this means and what to do Dose reminder goes Dose reminder is normally set by your doctor or nurse off at an unexpected to go off 30 minutes after your usual dose time. The time. reminder only goes off if you have not already used Dose Helper to save a dose.
Page 195: Sick Days, Travel Or Vacation, Changes In Diet Or Activity
Sick days, travel or vacation, changes in diet or activity What happened What this means and what to do You have a sick day. Follow your doctor’s advice on how to manage your diabetes on sick days. If you are not sure what to do or what dose to take, contact your doctor or nurse.
Page 196 What happened What this means and what to do You had a sudden If you are making significant changes to your diet or change in your diet level of activity, contact your doctor to get advice on or activity. how to manage your diabetes during this time. Sudden changes in diet or your activity can cause changes in your blood glucose.
Page 197: Dose Helper Unavailable" Warnings
“Dose Helper unavailable” warnings What happened What this means and what to do You tried to run Dose Helper outside of your usual dose time range. You can only run Dose Helper within three hours either side of your usual dose time. Check if the clock time on JAZZ™...
Page 198 What happened What this means and what to do You tried to run Dose Helper when your last dose was less than 18 hours ago. You can only run Dose Helper at least 18 hours after your last dose, and within three hours either side of your usual dose time.
Page 199: More Information Needed" Messages
“More information needed” messages What happened What this means and what to do You have not collected fasting blood glucose (BG) readings or insulin doses every day. Dose Helper cannot increase your suggested dose if you have not collected three of the last four fasting blood glucose readings and the insulin dose that you took each day.
Page 200: Dose Suggestion Not Possible" Warnings
“Dose suggestion not possible” warnings When you receive a “Dose suggestion not possible” warning, do the following: If you are not sure about what to do or what dose to take, contact your doctor or nurse. Dose Helper needs three fasting blood glucose readings from the last three days and the insulin dose that you took each day before giving you dose...
Page 201 What happened What this means Dose Helper needs Dose Helper cannot suggest a dose because you more fasting have not collected enough fasting blood glucose (BG) BG and/or dose readings or insulin doses. Dose Helper needs a minimum information. amount of fasting blood glucose readings and the insulin dose that you took before each fasting blood glucose reading to give suggestions (see page 76).
Page 202 What happened What this means You recently took a Dose Helper cannot suggest a dose because you took a dose outside your dose outside the usual dose time. usual dose time of If the usual dose time does not fit your daily routine you 19:00* (16:00* to can change it in the settings menu.
Page 203 What happened What this means 2 doses taken less Dose Helper cannot suggest a dose because you took than 18 hours apart. two doses within 18 hours. Taking two doses too close together may cause low blood glucose and affects Dose Helper.
Page 204 What happened What this means You changed your Dose Helper cannot suggest a dose because you took dose. different doses from the suggested dose. Dose Helper needs a minimum amount of fasting blood glucose readings and insulin doses. These insulin doses need to be at a consistent dose.
Page 205 What happened What this means Dose Helper cannot Dose Helper cannot restart because you recently had restart if you two or more fasting blood glucose (BG) readings below recently had BG your fasting blood glucose target range. Dose Helper needs to gather new fasting blood glucose below your fasting BG target range.
Page 206 What happened What this means Dose Helper cannot Dose Helper cannot restart because you recently entered restart unless you differing doses. Dose Helper needs a minimum amount consistently take the of fasting blood glucose readings and insulin doses at same dose. the same daily dose in order to give suggestions (see page 76).
Page 207: Seek Guidance" Warnings
“Seek guidance” warnings When you see a “Seek guidance” warning, contact your doctor or nurse. Press “OK” to confirm the warning. Press “Details” to get more information.
Page 208 What happened What this means You had very low BG. You had a blood glucose (BG) reading less than 3.1 mmol/L. You had very low BG You had a blood glucose (BG) reading less than or hypo symptoms 3.1 mmol/L or you reported very low blood glucose needing help.
Page 209 What happened What this means Dose Helper will You have almost reached the maximum dose that turn off if your dose Dose Helper can suggest for you. Dose Helper will stop reaches 200 Units. suggesting doses when you reach the maximum dose limit.
Page 210: Dose Helper Off" Warnings
“Dose Helper off” warnings When you see a “Dose Helper off” warning, do the following: If you are not sure about what to do or what dose to take, contact your doctor or nurse. To use Dose Helper it must be turned on by your doctor or nurse.
Page 211 What happened What this means Dose Helper has not Your doctor or nurse has not turned Dose Helper on for been turned on. you. You did not provide You have not used Dose Helper to get a dose suggestion Dose Helper with in the last 30 days.
Page 212 What happened What this means You turned off Dose You or your doctor or nurse turned off Dose Helper. Helper. Dose Helper is You indicated to Dose Helper that you switched to only for use with multiple dosing. Dose Helper can only be used with once-daily insulin insulin glargine taken once-daily.
Page 213: Dose Helper Interrupted" Warning
“Dose Helper interrupted” warning What happened What this means JAZZ™ DoseCoach was turned off or timed out during ® your last use of Dose Helper. Press “OK” to confirm the warning. Dose Helper will restart (see page 99) and may show additional warnings.
Page 214: Back Button Unavailable" Warning
“Back button unavailable” warning What happened What this means You pressed the back button when Dose Helper was unable to go back in dose calculations. If you need to enter missing hypo or dose information you should restart Dose Helper. Press “OK”...
Page 215: Expiration Warnings
Expiration warnings What happened What this means During Dose Helper setup your doctor or nurse will set an expiry date for your treatment plan. After this period, Dose Helper activation expires. It can be renewed by your doctor or nurse. JAZZ™...
Page 216 What happened What this means JAZZ™ DoseCoach has an internal coin cell battery. ® This battery has run empty. Therefore, Dose Helper has expired and can no longer be used or activated. JAZZ™ DoseCoach can continue to be used for ®...
Page 217: At And Out Of Fasting Blood Glucose Target Messages
At and out of fasting blood glucose target messages What happened What this means Your fasting blood glucose (BG) readings have been consistently within your fasting blood glucose target range. Dose Helper should still be used but no further dose increases will be suggested unless your fasting blood glucose regularly goes out of fasting blood glucose target.
Page 218 What happened What this means Your recent fasting blood glucose (BG) readings were above the fasting blood glucose target range. Use Dose Helper to get suggestions for adjusting your insulin glargine dose. >> See page 99 for getting dose suggestions again.
Page 219: Section 11. Jazz™ Dosecoach ® Specifications
Section 11: JAZZ™ DOSECOACH ® SPECIFICATIONS If you need further help after reading these instructions, please contact your healthcare professional, or call customer service at 0800 093 1812.
Page 220: Jazz™ Dosecoach ® Specifications
JAZZ™ DoseCoach specifications ® Assay method: dynamic Operating relative humidity: 25% to electrochemistry. 90%. Maximum altitude: 10,000 feet Operating temperature: 10°C to 40°C. (3,048 meters). Control solution storage temperature: Calibration: plasma equivalent. 2°C to 30°C. Coding: no code. Test strip storage temperature: 8°C to 30°C.
Page 221 Weight: 100g (3.5oz) including batteries. between JAZZ™ DoseCoach and the ® Equipment not suitable for use in the affected device. presence of flammable mixtures. SEGGER is a licensor of the JAZZ™ This JAZZ™ DoseCoach complies DoseCoach software. ® ® with the applicable standards for Electromagnetic Compatibility;...
Page 222: Jazz™ Dosecoach ® Performance Results
JAZZ™ DoseCoach Performance Results ® N= 600 Range of reference values: <1.68 to 29.1 mmol/L Finger stick summary of system accuracy results for glucose concentrations <5.5 mmol/L: Within ± 0.28 mmol/L Within ± 0.56 mmol/L Within ± 0.83 mmol/L 113/180 (62.8%) 162/180 (90.0%) 180/180 (100.0%) Finger stick summary of system accuracy results for glucose concentrations...
Page 223 Summary of total number of acceptable results per EN ISO 15197:2015 Total (percent) Acceptance criterion of 95% within ± 0.83 mmol/L and within ± 15% 581/600 (96.8%) Meets Criterion All results were within the clinically acceptable A and B zones of the Parkes Error Grid with 100% falling within zone A.
Page 224 Precision: The repeatability of the test strips and meter was evaluated with blood samples and control solution in the laboratory. Repeatability (Within Run) Blood Level 1 Level 2 Level 3 Level 4 Level 5 Average, 12.4 21.4 mmol/L SD, mmol/L 0.13 0.18 0.20...
Page 225 Accuracy for Lay Users: A study evaluating glucose values from fingertip capillary blood samples obtained by 101 lay persons showed the following results: 94.1% within ±0.83 mmol/L of the medical laboratory values at glucose concentrations below 5.5 mmol/L, and 98.8% within 15% of the medical laboratory values at glucose concentration at or above 5.5 mmol/L.
Page 226: Symbols Used On Packaging
Symbols used on packaging Serial Number: a unique number Temperature limitation: store that belongs to your JAZZ™ at a temperature above 8°C DoseCoach and below 30°C. ® Manufacturer. Use by. In Vitro Diagnostic Medical Catalogue number. Device. European Authorised Batch code. Representative.
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Page 228 8100-10395 Rev A...

AgaMatrix JAZZ DoseCoach Owner's Manual

Section 1. KEY INFORMATION about JAZZ™ DOSECOACH

Section 2. GETTING STARTED with JAZZ™ DOSECOACH

Section 3. USING YOUR BLOOD GLUCOSE METER

Section 4. USING DOSE HELPER

Section 5. REVIEWING YOUR HISTORY DATA

Section 6. CHANGING the JAZZ™ DOSECOACH ® SETTINGS

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