AgaMatrix JAZZ DoseCoach Owner'S Manual Download Page 2

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CAUTION: Please read all the instructions provided in this owner’s guide and practice the testing

procedures before using the JAZZ™ DoseCoach

Blood Glucose Meter. Self blood glucose monitoring

should be done under the guidance of a healthcare professional.

Customer Service:

UK Careline number 0800 093 1812

www.agamatrix.co.uk

In case of emergency, contact your healthcare professional or emergency medical response.

Manufacturer:

AgaMatrix, Inc.

7C Raymond Avenue

Salem, NH 03079 USA

MDSS GmbH

Schiffgraben 41

30175 Hannover

Germany

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. For patent

information, see www.agamatrix.com/patents.

Key features of JAZZ™ DoseCoach

•  Dose Helper.
•  Blood Glucose Meter.
•  Tagging blood glucose readings.
•  No coding required: The JAZZ™ DoseCoach

Blood Glucose Meter does not require a calibration

code. After inserting an AgaMatrix WaveSense JAZZ test strip, JAZZ™ DoseCoach

is ready to

measure your blood glucose.

Summary of Contents for JAZZ DoseCoach

Page 1: ...Dose Helper and blood glucose meter OWNER S GUIDE ...

Page 2: ...SA MDSS GmbH Schiffgraben 41 30175 Hannover 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 For patent information see www agamatrix com patents Key features of JAZZ D...

Page 3: ...ecord 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 What to do in case of sick days changes to diet or activity travel or vacation Healthcare professional contact details ...

Page 4: ...H JAZZ DOSECOACH 25 What comes in the box 26 Get to know JAZZ DoseCoach 28 The main menu 30 Getting started 31 Section 3 USING YOUR BLOOD GLUCOSE METER 39 Important safety information 40 Important health related information 41 About the lancing device 43 About the AgaMatrix WaveSense JAZZ test strips 45 Getting the lancing device ready 46 Measure your blood glucose 50 Dispose of the lancet and the...

Page 5: ...Getting dose suggestions again if a dose suggestion is not possible 99 Section 5 REVIEWING YOUR HISTORY DATA 107 About your history data 108 Logbook 112 Fasting blood glucose Fasting BG 118 Averages 125 Standard day 127 Dose Helper history 129 Section 6 CHANGING THE JAZZ DOSECOACH SETTINGS 133 Accessing the settings menu 134 The clock setting menu 136 Changing the Time or Date 137 Changing the tim...

Page 6: ...e Hypo rules 150 Reviewing the user agreement 151 Turning Dose Helper off 152 Section 7 MAINTAINING YOUR JAZZ DOSECOACH 153 Performing a control solution test 154 Important disinfection procedures 161 Looking after JAZZ DoseCoach 167 Changing your JAZZ DoseCoach batteries 168 Discarding your JAZZ DoseCoach and batteries 170 Section 8 QUESTIONS AND ANSWERS ON JAZZ DOSECOACH 171 General questions an...

Page 7: ...n diet or activity 193 Dose Helper unavailable warnings 195 More information needed messages 197 Dose suggestion not possible warnings 198 Seek guidance warnings 205 Dose Helper off warnings 208 Dose Helper interrupted warning 211 Back button unavailable warning 212 Expiration warnings 213 At and out of fasting blood glucose target messages 215 Section 11 JAZZ DOSECOACH SPECIFICATIONS 217 JAZZ Dos...

Page 8: ...Contents 6 This page has been left blank on purpose ...

Page 9: ...Section 1 Key information about JAZZ DoseCoach 7 Section 1 KEY INFORMATION ABOUT JAZZ DOSECOACH This section gives you important safety information about your JAZZ DoseCoach ...

Page 10: ...ey 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 If you are not sure where to find information remember to use the contents page at the beginning of the owner s guide to help you ...

Page 11: ...d glucose and keep a record of your blood glucose readings JAZZ DoseCoach is for single patient use only Do not share JAZZ DoseCoach with anyone else including other members of your family Before you start using JAZZ DoseCoach you must Select a user icon so you know which JAZZ DoseCoach is yours Remember to check this icon each time you turn JAZZ DoseCoach on Your healthcare professional should al...

Page 12: ...ce Before you dispose of JAZZ DoseCoach make sure you remove the batteries including the coin cell battery See page 168 for how to remove the batteries Who to contact for help and further information If you have any questions about your treatment contact your healthcare professional See page 1 for your healthcare professionals contact details If you have any problems using JAZZ DoseCoach call cust...

Page 13: ...stions Usual dose time the time you are meant to run Dose Helper to get dose suggestions Your doctor or nurse sets this on your JAZZ DoseCoach See page 148 for changing the usual dose time Lancet needle the lancet unit used to lance pierce the skin Strip port the opening in the base of your JAZZ DoseCoach where you insert your test strip Strip vial the container that the AgaMatrix WaveSense JAZZ t...

Page 14: ... settings It is important that your usual fasting time is set correctly so it matches your daily routine Hypoglycaemia hypo you might get symptoms of hypoglycaemia if your blood glucose is too low below 3 9 mmol L 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 s...

Page 15: ...ons and other icons you will see on the JAZZ DoseCoach screen Blood glucose icons Fasting tag Before meal tag After meal tag Before bedtime tag No tag Warning triangle high or low blood glucose reading Fasting blood glucose in target Insulin dose icons Insulin dose recorded No dose suggestion given Unknown dose amount saved Multiple doses saved in one day ...

Page 16: ...ed sections show the number of pairs dose fasting blood glucose you have collected In fasting blood glucose target star on the dose saved screen The star is filled when the most recent pair dose fasting blood glucose has been collected History icons Warning triangle for low blood glucose readings or reported low blood glucose or hypo symptoms Dose Helper Time Date ...

Page 17: ...Screen type icons Question screen Information screen Warning screen Menu icons History Settings 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: ...d glucose readings Dose increases or decreases are suggested in line with the treatment plan set up by your doctor or nurse Dose Helper should be used as one part of your self titration treatment program lead by your doctor or nurse See Section 4 for more information on Dose Helper Only use Dose Helper to suggest doses for the type of insulin your doctor or nurse has activated it for You can check...

Page 19: ...stion or it could be incorrect If you took any dose s in the last day that you did not save in Dose Helper then you will be given the chance to enter it when you next run Dose Helper Always run Dose Helper before you take a dose Use Dose Helper to save all doses you take Dose Helper needs at least three days of dose and fasting blood glucose data to give dose suggestions When you first use Dose He...

Page 20: ...e page 99 for getting dose suggestions again You make the decision on what dose you will take Dose Helper is a guide It gives you a suggested dose It is not a substitute for your judgement or for advice given by your doctor or nurse You must make the final decision on what dose you will take This is because you know more about your situation than Dose Helper does for example if you feel ill if you...

Page 21: ...w and you may get symptoms of hypoglycaemia If you change your daily routine you might need to take a different dose Dose Helper adjusts your dose based on past information It cannot plan ahead for days when you are ill or significantly change your daily routine such as the amount you eat or activity you do Changes to your daily routine can affect your blood glucose levels and you may need to take...

Page 22: ...er before you take a dose When Dose Helper suggests an insulin glargine dose take your dose straight away Do not 8 8Do not use Dose Helper if you have gestational diabetes 8 8Do not use Dose Helper if you do not take your insulin glargine dose once daily or if you do not take it at around the same time every day 8 8Do not use Dose Helper if you take any insulin other than insulin glargine 8 8Do no...

Page 23: ... control Blood glucose measurements are done outside the body in vitro use See Section 3 for more information on the Blood Glucose Meter Do not 8 8Do not use the Blood Glucose Meter to diagnose diabetes 8 8Do not use the Blood Glucose Meter for measuring blood glucose of neonates children under 4 weeks old 8 8Do not use the Blood Glucose Meter if you are testing blood from somewhere other than you...

Page 24: ...er to suggest insulin glargine doses To tag a blood glucose reading as fasting select the fasting tag when prompted on the screen You can only tag a blood glucose reading as fasting if you have measured your blood glucose during the 4 hour fasting window See page 13 for descriptions of the tag icons See page 50 for information on how to measure your blood glucose and tag your reading See page 140 ...

Page 25: ... If you do not have hypo or hyper symptoms measure your blood glucose again carefully following the instructions in this owner s guide If you get hypo or hyper symptoms or continue to get blood glucose readings below 3 9 mmol L or above 13 3 mmol L follow your treatment plan or contact your healthcare professional right away 3 If you have hypo or hyper symptoms that are not consistent with your bl...

Page 26: ...Section 1 Key information about JAZZ DoseCoach 24 This page has been left blank on purpose ...

Page 27: ...Section 2 Getting Started with JAZZ DoseCoach 25 Section 2 GETTING STARTED WITH JAZZ DOSECOACH This section shows you how to get started with JAZZ DoseCoach ...

Page 28: ...ts not shown Carrying case This owner s guide Quick reference guide Test strip insert Registration card Prescription card Log book JAZZ DoseCoach 2 AA lithium batteries 1 vial of 10 AgaMatrix WaveSense JAZZ test strips AgaMatrix control solution Lancing device with cap 10 sterile lancets ...

Page 29: ...ed with 8 8Do not bend cut or alter AgaMatrix WaveSense JAZZ test strips Do 4 4 Store AgaMatrix WaveSense JAZZ test strips in their original vial in a cool dry place at 8 C to 30 C 4 4 Tightly close the vial of AgaMatrix WaveSense JAZZ test strips after you have removed a test strip 4 4 Store your lancing device at room temperature protected from sunlight and moisture ...

Page 30: ...own in the black band at the bottom of the screen d Power back button press this button to turn on JAZZ DoseCoach or to go back a step Press and hold this button to turn JAZZ DoseCoach off e Dose Helper button press this button to launch Dose Helper see page 71 f Up and down buttons press these buttons to choose an option or to show more information g Strip port insert an AgaMatrix WaveSense JAZZ ...

Page 31: ...orm a meter system check Do not use JAZZ DoseCoach and call customer service at 0800 093 1812 if any areas of the start up screen appear to be missing There are three possible start up screens that might be shown see below Note Your user icon may be different to the icon shown in the examples below ...

Page 32: ...menu a a a b a c a d a e 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 a Date and time b Battery icon c User icon d History menu option e Settings menu option ...

Page 33: ...ons in this owner s guide before using your JAZZ DoseCoach Set the language The first time you use JAZZ DoseCoach you will be asked to set the language If the language has already been set by your healthcare professional go to Step 2 Press to turn on JAZZ DoseCoach Choose the language Then press Save 1 ...

Page 34: ...Coach 32 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 2 ...

Page 35: ...ugh 3 Select your user icon The user icon helps you identify your own JAZZ DoseCoach and helps to prevent getting it confused with someone else s Every time you turn on JAZZ DoseCoach your user icon will appear The user icons you can choose from are shown below It is also shown on some other screens such as when you receive a dose suggestion Choose an icon Save your selection 4 ...

Page 36: ...seCoach 34 Do 4 4 Check your user icon is shown each time you use JAZZ DoseCoach Do not 8 8Do not use JAZZ DoseCoach if you see a user icon that is not yours 8 8Do not share your JAZZ DoseCoach or use someone else s it is meant for you only ...

Page 37: ...Setting the correct time and date is important for JAZZ DoseCoach If the time and date are not set correctly Dose Helper will not work properly If the time and date have not been set before this screen will not be shown You will be asked to set the clock If time and date are correct press Yes If not press No 5 ...

Page 38: ... you to correct the clock settings Set the correct year Go to the Next setting step Repeat this to set month day hour and minutes Save the clock changes at the last setting step Read the definition of Fasting BG Read the fasting blood glucose definition carefully Then go to the Next screen 6 ...

Page 39: ...eading 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 after sleeping and before breakfast when you have not eaten or had a drink containing sugar glucose for at least 8 hours Press to go back to previous screens ...

Page 40: ...ng time sets the middle point of a 6 hour fasting window You can only tag label blood glucose readings as fasting during this 6 hour window Choose a time for fasting that will fit your sleeping and eating habits Save the usual fasting time See page 140 for changing the usual fasting time See page 50 for how to tag your blood glucose readings 7 ...

Page 41: ...Section 3 USING YOUR BLOOD GLUCOSE METER This section shows you how to measure your blood glucose using JAZZ DoseCoach Section 3 Using your Blood Glucose Meter 39 ...

Page 42: ...lood or control solution to the AgaMatrix WaveSense JAZZ test strip never apply blood or control solution directly to the strip port on JAZZ DoseCoach This might cause a system failure Do not 8 8Do not use AgaMatrix WaveSense JAZZ test strips after the expiry date or 180 days after first opening the vial They may give inaccurate blood glucose readings 8 8Do not use AgaMatrix WaveSense JAZZ test st...

Page 43: ...t blood glucose readings below 3 9 mmol L or above 13 3 mmol L and do not have symptoms of hypoglycaemia or hyperglycaemia repeat the test If you have symptoms or continue to If you are critically ill do not use the Blood Glucose Meter Inaccurate blood glucose readings may occur If your haematocrit levels are below 20 or above 60 If your blood pressure is very low hypotension or if you are in shoc...

Page 44: ... all instructions described in this owner s guide follow your healthcare professional s recommendations 5 If you get repeated error messages and have symptoms of hypo or hyperglycaemia contact your healthcare professional right away as this may mean low or high blood glucose If this error code persists on measuring again contact your healthcare professional See page 177 for information on Blood Gl...

Page 45: ...cing device Do 4 4 Always use a new lancet placed into the lancing device directly before measuring your blood glucose 4 4 Discard the lancet after measuring your blood glucose 4 4 Clean the lancing device cap after using it 4 4 Always dispose of the used lancet in a safe way for example in a puncture resistant container according to local regulations Follow your healthcare provider s instructions...

Page 46: ...o the largest dot highest setting d Release button fires the lancet e Lancet ejector safely ejects the used lancet f Lancet holder holds the lancet into place inside the lancing device g Lancing device cap covers the lancet when in lancing device h Lancet lances the skin to produce a drop of blood i Lancet cover covers the lancet for safety Remove after inserting into the lancet holder Available l...

Page 47: ...ix WaveSense JAZZ test strip is white a Contact bars this end is inserted into the JAZZ DoseCoach strip port b Fill window this window will turn red when enough blood has been applied This window will turn blue when enough control solution has been applied c Sample area blood or control solution should be applied to the tip of this area When blood is applied to the AgaMatrix WaveSense JAZZ test st...

Page 48: ...roughly dry your hands 1 Remove the cap Twist the cap off the lancing device by turning it counter clockwise while holding the base firmly 2 Insert a new lancet Load a new sterile lancet directly into the bottom of the lancet holder In case you accidently cocked the device at this point press the release button before you move on 3 ...

Page 49: ...ncet cover While holding the lancet firmly twist pull the lancet cover in a straight direction to remove To avoid injury be careful not to touch the lancet tip 4 Put the cap of the lancing device back on by turning it clockwise until it is fully into place 5 ...

Page 50: ...e skin penetration depth by sliding the depth selector to the desired depth The 5 dots represent the 5 levels of depth settings with the largest dot highest setting on the left progressing to the smallest dot lowest setting on the right If you have never lanced before it is recommended that you start at the third dot 6 ...

Page 51: ... Blood Glucose Meter 49 Cock the lancing device Pull the cocking handle out until it clicks This will cock the lancing device 7 Do not 8 8Do not lance your finger before JAZZ DoseCoach and the test strips are ready to use ...

Page 52: ...rtip excluding thumb and index finger 4 4 Make sure there is no grease oil or lotion on the fingertip you are going to use 4 4 Keep your hand warm or gently massage the site you are lancing to help your blood flow 4 4 Check the expiration date use by on your AgaMatrix WaveSense JAZZ test strips before you use them Measure your blood glucose ...

Page 53: ...carefully with soap and warm water to increase the circulation of the blood into the fingers Make sure there is no grease oil or lotion on the fingertip you are going to use Keep your hand warm or gently massage the site you are lancing to help your blood flow 1 ...

Page 54: ...seCoach will turn on when the test strip is fully inserted Check the user icon on the start up screen Never use a JAZZ DoseCoach that is not yours You will see this screen when JAZZ DoseCoach is ready for a sample of blood If you do not apply blood within 4 minutes of inserting the AgaMatrix WaveSense JAZZ test strip JAZZ DoseCoach will turn off To restart remove the test strip and reinsert it 2 ...

Page 55: ...lancing device Hold the lancing device firmly against the side of the fingertip with the cap resting on the fingertip Note the harder you press the lancing device against the finger the deeper the puncture Press the release button to get a blood sample 3 ...

Page 56: ...m the base of your finger up 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 You might need to use a larger lancet to produce enough blood 4 Do not 8 8Do not squeeze directly around the lanced area ...

Page 57: ...rn red When you hear the beep remove the AgaMatrix WaveSense JAZZ test strip from the blood sample Do not apply any more blood to the AgaMatrix WaveSense JAZZ test strip after the beep An animation will appear on the screen while JAZZ DoseCoach is calculating your blood glucose reading Keep the AgaMatrix WaveSense JAZZ test strip inserted until you have completed the remaining steps 5 ...

Page 58: ...est strip If the problem continues call customer service at 0800 093 1812 If the fill window on the AgaMatrix WaveSense JAZZ test strip does not completely fill you may get an inaccurate blood glucose reading Measure your blood glucose again with a new AgaMatrix WaveSense JAZZ test strip and make sure the fill window is completely full Do not 8 8Do not put blood on the top surface of the AgaMatrix...

Page 59: ...t 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 Your fasting blood glucose readings are used to decide if your insulin dose should be increased or decreased You have to tag or mark your readings when they are fa...

Page 60: ... window JAZZ DoseCoach will ask you to confirm if the reading is a fasting blood glucose reading You have 1 additional hour on either side to manually tag the reading as a fasting blood glucose measurement If it is a fasting reading press Yes If it is not a fasting reading press No If you pressed No you will be asked to choose the correct tag 7 ...

Page 61: ...reen appears one of the options is highlighted The suggested tag changes with the time of day based on the tag time settings If you measure your blood glucose outside the 6 hour fasting window the fasting tag will not be available and will be greyed out Select the correct tag option Then press Save See page 13 for descriptions of the tag icons See page 140 for messages that may be triggered by tag...

Page 62: ...rip The JAZZ DoseCoach will turn off See page 175 for questions and answers on using the Blood Glucose Meter 10 If you choose the wrong tag and the blood glucose reading is still shown on the screen you can go back and change the tag If you turn JAZZ DoseCoach off or move to the main menu you will not be able to go back and change the tag You will need to measure your blood glucose again if you ne...

Page 63: ...while holding the base firmly 1 Dispose of the lancet and the test strip Used test strips lancets and lancing devices may present a risk to the health of humans animals or the environment biohazardous medical waste in your city or town Dispose of used materials properly Follow your healthcare provider s instructions for disposal ...

Page 64: ... Push the lancet ejector downward with your thumb ejecting the lancet safely into an appropriate sharps container Do not dispose of the lancing device Wash your hands thoroughly after handling JAZZ DoseCoach the lancet lancing device and test strips 2 Put the cap of the lancing device back on by turning it clockwise until it is fully into place 3 g to ody ...

Page 65: ...he screen The color of the screen will depend on your blood glucose reading a Blood glucose reading the large numbers on the screen show the measured blood glucose b Units of measurement mmol L c Date of blood glucose reading d Time of blood glucose reading e Tag f Message area not all blood glucose readings have messages See page 65 for possible messages a a a b a c a d a e a f ...

Page 66: ...lucose limit Blue is for readings between the lower general BG target and 10 0 mmol L Red is for readings below the low blood glucose limit If Dose Helper is turned off this value is set by the higher general BG target limit Pink is for readings below the general BG target 33 3 mmol L 10 0 mmol L 1 1 mmol L General BG target limits Low blood glucose limit High blood glucose limit ...

Page 67: ...be advisable See page 67 for what to do if your blood glucose readings are high or low In fasting blood glucose target When your doctor or nurse turns Dose Helper on for you they will set your fasting blood glucose target range The fasting blood glucose in target icon will be shown if you tag a blood glucose reading as fasting and the reading is within your fasting blood glucose target range and D...

Page 68: ...our blood glucose readings are high or low You might get symptoms of hypoglycaemia if your blood glucose is too low below 3 9 mmol L Common symptoms of hypoglycaemia are palpitations sweating hunger dizziness tingling blurred vision difficulty in thinking faintness anxiety Your symptoms may vary and you may have other symptoms Contact your healthcare professional for more details ...

Page 69: ...L and you have hypo or hyper symptoms follow your treatment plan or contact your healthcare professional right away 2 If you do not have hypo or hyper symptoms measure your blood glucose again carefully following the instructions in this owner s guide If you get hypo or hyper symptoms or continue to get blood glucose readings below 3 9 mmol L or above 13 3 mmol L follow your treatment plan or cont...

Page 70: ...al reading Check if the times are correct for your eating habits These times will determine the meal for which your before meal and after meal tags are saved Check the tag times If the tag times are correct press Yes If not press No You will be forwarded to the usual tag time settings See page 140 for changing the tag times 1 ...

Page 71: ...g blood glucose reading close to a reading that you tagged as a before meal or after meal reading Check if this is really a fasting blood glucose reading Press Yes to save the fasting blood glucose reading If you do not want to tag a fasting blood glucose reading press No 1 Press to go back to previous screens Fasting blood glucose is measured after sleeping and before breakfast when you have not ...

Page 72: ...ll appear if you have tagged more than one fasting blood glucose reading and need to choose one for Dose Helper to use Select the correct fasting reading Choose the fasting blood glucose reading to be used for Dose Helper Press Select Or press Details to get more information 1 ...

Page 73: ...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 Section 4 Using Dose Helper 71 ...

Page 74: ... your usual dose time Ask your doctor or nurse what time of the day you should take your insulin glargine dose Always run Dose Helper if you intend to take a dose 4 4 If your doctor or nurse told you to take your once daily insulin glargine dose in the morning measure your fasting blood glucose before running Dose Helper and taking your dose 4 4 Dose Helper requires you to have consistent diet act...

Page 75: ...t run Dose Helper You did not take your insulin glargine dose See page 198 for other cases where Dose Helper may not be able to give a dose suggestion Only use Dose Helper to suggest doses for the type of insulin your doctor or nurse has activated it for You can check the type of insulin Dose Helper can be used with in the user agreement See page 151 for how to review the user agreement If you are...

Page 76: ...t by your doctor or nurse The grey bars show the insulin glargine dose taken each day b a 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 nurse Dose Helper will help you adjust your insulin glargine dose If Dose Helper has all the information needed it may suggest a dose increase...

Page 77: ...blood glucose target range The suggested dose is meant for you only Do not share your JAZZ DoseCoach with anyone else Dose Helper can be run 3 hours either side of the usual dose time glucose is above your fasting blood glucose target range See page 76 for adjustment details It can take between one to three months to find the dose that works for you Do not worry if it takes some time to get there ...

Page 78: ...mation needed See page 198 if you get a message Dose suggestion not possible a Dose Helper needs your fasting blood glucose fasting BG readings It can only use these if you also entered your previous insulin dose Dose Helper pairs these together For example a pair might be yesterday s dose and today s fasting blood glucose reading b The number of pairs dose fasting blood glucose collected is shown...

Page 79: ...Section 4 Using Dose Helper 77 c 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: ... fasting blood glucose readings are below your fasting blood glucose target range You get any low blood glucose readings or report any hypo symptoms Dose Helper helps you adjust your insulin glargine dose based on past information It cannot plan ahead for sudden changes for example Sick days Travel or vacation Changes in diet or activity If you are not sure what dose to take in these situations ch...

Page 81: ...se Measure your fasting blood glucose every day Run Dose Helper and enter your insulin glargine dose every day Before you start using Dose Helper you need to know How to measure your blood glucose and tag fasting blood glucose readings How to recognise and treat hypo symptoms How to use your insulin glargine safely What to do in case of sick days travel or vacation or changes in diet or activity W...

Page 82: ... The first time you run Dose Helper you will be told about the Dose Helper button 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 see page 187 for questions and answers on using Dose Helper 1 ...

Page 83: ...elper menu appears on the screen each time you run Dose Helper by pressing Choose Take a dose Then go to the Select screen Or press Exit to go back to the main menu See page 133 for how to change the Dose Helper settings 2 Press to go back to previous screens ...

Page 84: ... to the end Then Confirm the user agreement Or press Decline Dose Helper will only work if you confirm the user agreement 3 Read the welcome message This shows the next steps you will go through Then go to the Next screen 4 Press to go back to previous screens ...

Page 85: ...symptoms may vary and you may have other symptoms Contact your healthcare professional for more details Correctly reporting any hypo symptoms or low blood glucose readings is important to get correct dose suggestions Dose Helper knows about any low blood glucose measured with JAZZ DoseCoach These questions tell Dose Helper about any hypo symptoms you had or if you measured low blood glucose with a...

Page 86: ... you have not had any low blood glucose readings or hypo symptoms in the last day s press No If you have press Yes If you pressed Yes you will be asked another hypo question to find out how bad your hypo was When you are asked to confirm your hypo press Save 6 ...

Page 87: ...ose Helper 85 Read the previous dose message The first time you run Dose Helper you do not need to enter any previous doses Press OK 7 So that Dose Helper can provide dose suggestions all previous doses must be recorded ...

Page 88: ...give a dose suggestion on day 4 See page 76 for more information Therefore follow the instructions on the screen every day for the next three days Go to the Next screen Or press Details to get more information 8 Decide whether to take a dose If you will take a dose now press Yes If you will not take a dose now press No This will take you back to the main menu 9 Press to go back to previous screens...

Page 89: ... nurse is shown on the screen It is 10 units in this example After you have entered an insulin glargine dose press Next to take you to the next step Until you enter an insulin glargine dose Next will be grey and you cannot go on Go to the Next screen Or press Cancel 10 Remember that you have to use Dose Helper every day for at least three days before Dose Helper can suggest a first dose ...

Page 90: ...Save the dose 11 Take your insulin glargine dose Take your insulin glargine dose immediately after you have saved your dose on JAZZ DoseCoach For details about taking insulin glargine please read the instructions that came with your injection device 12 Press to go back to previous screens ...

Page 91: ...ested by Dose Helper have a grey background The number of filled sections on the shooting star shows the number of pairs dose fasting blood glucose you have collected Turn JAZZ DoseCoach Off Or press Menu See page 76 for more information about the shooting star 13 ...

Page 92: ...een Never use a JAZZ DoseCoach that is not yours If you get a message on the screen after pressing the Dose Helper button see page 187 for questions and answers on using Dose Helper 1 Normal use of Dose Helper This section explains the steps for when you use Dose Helper every day and Dose Helper has enough information to make dose suggestions ...

Page 93: ...per menu The Dose Helper menu appears on the screen each time you run Dose Helper by pressing Choose Take a dose Then go to the Select screen Or press Exit to go back to the main menu See page 147 for how to change the Dose Helper settings 2 ...

Page 94: ...lucose readings on another blood glucose meter or hypo symptoms in the last day s press No If you did press Yes If you pressed Yes you will be asked another hypo question to find out how bad your hypo was When you are asked to confirm your hypo press Save 3 Press to go back to previous screens ...

Page 95: ...t 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: ...er the previous dose question If you have not taken any dose of insulin glargine since the last saved dose press No If you have press Yes If you pressed Yes you will be asked to enter the dose Enter the dose date Go to the Next screen 4 ...

Page 97: ...5 Repeat this to enter the dose time and dose amount If you are not sure what dose you took press Not sure If you get a message on the screen after answering this question see page 187 for questions and answers on using Dose Helper ...

Page 98: ...efully Find out more details about your suggested dose If you will take the suggested dose press Next If you will take a different dose press Change If you pressed Change you will be asked to enter the different dose Enter the insulin glargine dose that you will take now Go to the Next screen Or press Cancel 5 ...

Page 99: ...ve the correct dose Save the dose 6 Take your insulin glargine dose Take your insulin glargine dose immediately after you have saved your dose on JAZZ DoseCoach For details about taking insulin glargine please read the instructions that came with your injection device 7 ...

Page 100: ... Doses not suggested by Dose Helper i e doses entered manually have a grey background The number of filled sections on the shooting star shows the number of pairs dose fasting blood glucose you have collected Turn JAZZ DoseCoach Off Or press Menu See page 76 for more information about the shooting star 8 ...

Page 101: ...e of insulin glargine at your usual time You should still complete the Dose Helper steps in order to enter your dose information 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 suggestions again on day 4 In these three days Measure your fasting blood glucose every day Run Dose Helper and enter your i...

Page 102: ... 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 see page 187 for questions and answers on using Dose Helper 1 ...

Page 103: ...Helper menu appears on the screen each time you run Dose Helper by pressing Choose Take a dose Then go to the Select screen Or press Exit to go back to the main menu See page 147 for how to change the Dose Helper settings 2 Press to go back to previous screens ...

Page 104: ... suggestion cannot be made Go to the Next screen To find out about Dose Helper warning messages see page 187 for questions and answers on using Dose Helper Therefore follow the instructions on the screen every day for the next three days Go to the Next screen Or press Details to get more information 3 ...

Page 105: ...your dose and you know what dose to take If you will take a dose now press Yes If you will not take a dose now press No This will take you back to the main menu Always record your insulin glargine dose in Dose Helper 4 If you are not sure about what dose to take contact a doctor or nurse ...

Page 106: ... glargine dose that you will take now Go to the Next screen Or press Cancel 5 Take your insulin glargine dose Take your insulin glargine dose immediately after you have saved your dose on JAZZ DoseCoach For details about taking insulin glargine please read the instructions that came with your injection device 7 Press to go back to previous screens ...

Page 107: ...gested by Dose Helper have a grey background The number of filled sections on the shooting star shows the number of pairs dose fasting blood glucose you have collected Turn JAZZ DoseCoach Off Or press Menu See page 76 for more information about the shooting star 8 ...

Page 108: ...Section 4 Using Dose Helper 106 This page has been left blank on purpose ...

Page 109: ...ta 107 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: ...s 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 Averages shows the average and standard deviation a measure of variability for different categories of readings taken in the last 7 14 30 and 90 days Advanced this option takes you to the Advanced history menu ...

Page 111: ...ag Dose Helper lists the doses suggested by Dose Helper and the doses that you saved to Dose Helper See page 107 for more information on the Advanced history menu See page 13 for a list of icons used in the history Do not 8 8Do not make treatment decisions based on stored blood glucose readings doses averages and graphs All health related decisions should be made with guidance from your healthcare...

Page 112: ...110 Accessing the History menu Press to turn on JAZZ DoseCoach Check the user icon on the start up screen Never use a JAZZ DoseCoach that is not yours 1 Select History Choose History Then press Select 2 Press to go back to previous screens ...

Page 113: ...Section 5 Reviewing your history data 111 Select an option Choose an option Then press Select More information about the History menu options is included on the following pages 3 ...

Page 114: ...112 Logbook About the Logbook a Date any blood glucose readings and insulin glargine doses are shown below the date they were saved on b More information use to show more information See page 13 for a list of all blood glucose icons a a a b ...

Page 115: ...lucose reading in this example the fasting blood glucose tag c Blood glucose reading shows the measured blood glucose Insulin doses This example shows an insulin glargine dose entry a Time time of the insulin glargine dose b Insulin dose icon shows that an insulin glargine dose was saved c Units the number of units of the insulin glargine dose a a a a a b a b a c a c Press to go back to previous s...

Page 116: ... on JAZZ DoseCoach has been changed Entries above the clock change are saved in the new time or date See page 136 for more information about changing the clock High blood glucose readings This example shows a high blood glucose reading entry Blood glucose readings above your high blood glucose limit are shown with an orange background ...

Page 117: ... your low blood glucose limit are shown with a red background Hypo symptoms This example shows an entry of reported low blood glucose or hypo symptoms On days where you had a low blood glucose reading or you reported low blood glucose below 3 9 mmol L or hypo symptoms in Dose Helper a logbook entry marked with a red triangle is made once for that day ...

Page 118: ...of reported low blood glucose less than 3 1 mmol L or severe hypo symptoms On days where you had a very low blood glucose reading or you reported very low blood glucose below 3 1 mmol L or severe hypo symptoms in Dose Helper a logbook entry marked with a red triangle is made once for that day ...

Page 119: ...Section 5 Reviewing your history data 117 This page has been left blank on purpose ...

Page 120: ...ng blood glucose readings and insulin glargine doses for the last 3 days 7 days shows your fasting blood glucose readings and insulin glargine doses for the last 7 days 6 weeks averages shows weekly averages of your fasting blood glucose readings and of your insulin glargine doses for the last 6 weeks a b a a aa aa ac ad ae ...

Page 121: ...stretched so that blood glucose readings for lower values get more space To see your exact blood glucose readings please consult your Logbook c Green area shows your fasting blood glucose target range if Dose Helper is turned on d Timescale runs from the starting date shown on the left to today shown on the right e Grey bars show the insulin glargine dose for a day or average dose for a week Insul...

Page 122: ...e you had a low blood glucose reading or you reported low blood glucose below 3 9 mmol L or hypo symptoms in Dose Helper a red triangle is shown once for that week The number in the triangle is the number of days within that week with a low blood glucose reading or with reported low blood glucose measured with another meter or hypo symptoms Press to go back to previous screens Note The hypo triang...

Page 123: ...ry data 121 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: ... Reviewing your history data 122 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: ...ion 5 Reviewing your history data 123 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: ...ange a If you see a zig zag line on a graph it means that the time or date was changed b 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 See page 198 for more details a b ...

Page 127: ...ays Then press Select b Average of all blood glucose readings or readings with the same tag c Standard deviation SD of all blood glucose readings or readings with the same tag d Shows the tag icon tag description and the number of blood glucose readings included in the calculation of the average and standard deviation 7 fasting blood glucose readings in this example e More information Scroll to sh...

Page 128: ...include the current day in their calculations Blood glucose readings of 33 3 mmol L or above and 1 1 mmol L or below will be included as values of 33 3 mmol L and 1 1 mmol L respectively Blood glucose readings without a valid time or date as well as control solution test results are not included in averages standard deviations and trend graphs Missing dose values are not included in averages stand...

Page 129: ... Select b The tags are ordered in sequence across the day from breakfast to lunch to dinner then before bed For each meal the before meal and after meal readings are shown in separate columns The first column shows the fasting and or before breakfast blood glucose readings If there are only fasting blood glucose readings the fasting icon is shown If there are any before breakfast readings then the...

Page 130: ... Orange line shows your high blood glucose limit d Grey dots show your blood glucose readings When readings overlap the dots appear darker e Red line shows your low blood glucose limit f Before meal tag g After meal tag h Meal name c d e g f a h ...

Page 131: ...ved a dose Each row shows a Date the date of the dose entry or entries a a a b a c Dose Helper history The Dose Helper history is accessed from the Advanced history menu b Suggested dose from Dose Helper c Taken saved dose If the taken dose was the same as the suggested dose it will be shown in blue as in this example Press to show more information Press to go back to previous screens ...

Page 132: ...e was different to the suggested dose it will be shown in black as in this example Unknown taken doses The means you confirmed that you took an insulin glargine dose but that you were unsure about the amount of insulin glargine you took Press to go back to previous screens ...

Page 133: ... you did not get a dose suggestion from Dose Helper that day Dose suggestion not possible The icon means that a dose suggestion was not possible that day For example Dose Helper did not have enough data to suggest a dose See page 71 for the information Dose Helper needs to suggest a dose ...

Page 134: ...Section 5 Reviewing your history data 132 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: ...he JAZZ DoseCoach settings 133 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: ...ZZ DoseCoach settings 134 Accessing the settings menu Press to turn on JAZZ DoseCoach Check the user icon on the start up screen Never use a JAZZ DoseCoach that is not yours 1 Select Settings Choose Settings Then press Select 2 ...

Page 137: ...ack to previous screens Select an option There are eight options in the Settings menu Clock Tagging User icon BG limits Volume Language Dose reminder Dose Helper Choose an option Then press Select These settings are described in more detail on the following pages 3 ...

Page 138: ...the 24 hour 13 00 or 12 hour 1 00pm format Date format you can choose between the day month year 26 March 2019 or month day year March 26 2019 format Choose an option Press Select to change the settings 1 The clock setting menu Changes to the time or date may affect Dose Helper Check the information recorded on page 1 or ask your doctor or nurse what to do if you travel or change your daily routin...

Page 139: ...r go to Step 2 Press OK 1 Set the time and date Set the correct year Go to the Next setting step Repeat this to set month day hour and minutes Save the clock changes at the last setting step If you get a Clock reset message it means you will need to change the clock again 2 Changing the Time or Date ...

Page 140: ... an option 24 hour e g 13 00 or 12 hour e g 1 00pm Save your changes Or press Cancel 1 Set the date format Choose an option day month year e g 26 March 2019 or month day year e g March 26 2019 Save your changes Or press Cancel 1 Changing the time format Changing the date format ...

Page 141: ...creased or decreased You have to tag or mark your readings when they are fasting Telling JAZZ DoseCoach which blood glucose readings are fasting is important for Dose Helper The fasting time sets the middle point of a 6 hour fasting window You can tag blood glucose readings as fasting during this 6 hour window However the fasting tag will only be suggested by JAZZ DoseCoach for two hours before an...

Page 142: ...gs Usual fasting time here 07 00 Usual breakfast time here 07 30 a The different shaded blocks show the tags that 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 b Fasting tags will be suggested two hours either side of the usual fasting time In this example from 5 00 to 9 00 ...

Page 143: ... a meal time to one hour after a meal time In this example before lunch tags will be suggested from 10 30 to 13 30 d After meal tags will be suggested from one hour to a maximum of four hours after a meal time if not limited by other blocks In this example after lunch tags will be suggested from 13 30 to 16 30 Note These are example values and may not reflect your treatment plan ...

Page 144: ...oseCoach settings 142 Select the usual tag time you would like to change Choose an option Then press Select 1 Set the usual time Change the selected tag time Save your changes Or press Cancel 2 Press to go back to previous screens ...

Page 145: ...on You must check the user icon on the start up screen each time you turn JAZZ DoseCoach on Never use a JAZZ DoseCoach that is not yours The user icons you can choose from are shown below Choose your user icon Save your changes Or press Cancel 1 Changing your user icon ...

Page 146: ... Change the blood glucose BG limits Save your changes Or press Cancel 2 Changing the blood glucose BG limits If Dose Helper is turned off you can set your High BG General BG target and Low BG limits If Dose Helper is turned on you can only set your High BG limit The Low BG and General BG target limits will be automatically set to default values ...

Page 147: ...ing the JAZZ DoseCoach settings 145 Set the volume Change the volume Save your changes Or press Cancel 1 Set the language Choose an option Save your changes Or press Cancel 1 Changing the volume Changing the language ...

Page 148: ...u when your dose of insulin glargine is due It does this by playing a sound The dose reminder goes off if you have not used Dose Helper to save a dose by the reminder time You can also change the dose reminder in the Dose Helper settings menu See page 133 Set the dose reminder Choose when you would like to be reminded to take your dose Save your changes Or press Cancel 1 ...

Page 149: ... options in the Dose Helper menu Dose time this is the time you usually take your insulin glargine dose Fasting BG rules you can view these but only your doctor or nurse can change them Hypo rules you can view these but only your doctor or nurse can change them User agreement here you can re read the user agreement that you confirmed before using Dose Helper Turn off this will turn Dose Helper off...

Page 150: ... either side of your usual dose time Change the dose time Save your changes Or press Cancel 2 Changing the usual dose time Changes to dose time may affect Dose Helper Ask your doctor or nurse what to do if you travel or change your daily routine Do 4 4 Take your dose at the usual time as told by your doctor or nurse Contact your doctor or nurse before changing your usual dose time ...

Page 151: ... 149 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: ... 150 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: ... Changing the JAZZ DoseCoach settings 151 Reviewing the user agreement Read the message Read the rest of the user agreement 1 In the user agreement you can check the type of insulin Dose Helper can be used with ...

Page 154: ...AZZ DoseCoach settings 152 Turning Dose Helper off Read the message If you want to turn Dose Helper off now press Yes If you do not want to turn Dose Helper off press No 1 Only your doctor or nurse can turn Dose Helper back on ...

Page 155: ...AINING YOUR JAZZ DOSECOACH Section 7 Maintaining your JAZZ DoseCoach 153 If you need further help after reading these instructions please contact your healthcare professional or call customer service at 0800 093 1812 ...

Page 156: ...You should only use AgaMatrix control solution with JAZZ DoseCoach 4 4 Always put the cap on the control solution bottle right after you have used it 4 4 Do not add water or any other liquid to the control solution 4 4 Control solution tests should be performed within the temperature range of 10 C to 40 C Control solution tests should be done when you First get your JAZZ DoseCoach Think your JAZZ ...

Page 157: ...fore every test Insert the test strip with the black side facing up JAZZ DoseCoach will turn on when the test strip is fully inserted You will see this screen when JAZZ DoseCoach is ready for the AgaMatrix control solution If you do not apply control solution within 4 minutes of inserting the test strip JAZZ DoseCoach will turn off To restart remove the test strip and reinsert it 1 ...

Page 158: ...nt levels of control solution normal or high Choose the level of AgaMatrix control solution you want to use Gently swirl the control solution bottle to make sure the control solution is mixed well Put a drop of control solution on a tissue then throw the tissue away Wipe the tip of the bottle using a clean tissue 2 ...

Page 159: ...trol solution on a clean surface such as a plastic bag Bring the tip of the test strip to the drop of AgaMatrix control solution The test strip fills from the tip The fill window of the test strip will turn blue JAZZ DoseCoach will beep once to tell you when you should remove the tip of the test strip from the drop 3 ...

Page 160: ...e 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 This image will appear on the screen while JAZZ DoseCoach is calculating your test result ...

Page 161: ...l solution level normal or high that you used when you compare the results Your control solution test result should fall within this range If your control solution test results are out of this range repeat the test 4 Results from control solution tests do not give you information about your blood glucose level The control solution range is a target range for control solution only It is not a targe...

Page 162: ...olution The JAZZ DoseCoach is not working properly The control solution test was done outside the temperature range of 10 C to 40 C Not mixing the control solution enough before using Not throwing away the first drop of control solution and wiping the bottle tip clean If the results from the control solution tests continue to be out of range do not use JAZZ DoseCoach to test your blood glucose Cal...

Page 163: ...hat you cannot see If JAZZ DoseCoach is being used by a second person who is caring for the patient JAZZ DoseCoach and the lancing device should be cleaned and disinfected before they are used by the second person To clean the lancing device cap take the cap off wash it in warm water rinse well and dry Do 4 4 Be careful when cleaning and disinfecting JAZZ DoseCoach 4 4 Avoid getting liquid inside ...

Page 164: ...smetic damage to JAZZ DoseCoach and the lancing device EPA Brand Name Manufacturer Available at Contact time 9480 4 Super Sani Cloth Germicidal Disposable Wipes Professional Disposables International Inc PDI Online Amazon com Officedepot com 2 minutes Active ingredient Quaternary ammonium chlorides and isopropanol Note Availability of disinfecting wipe may vary For updated information call custome...

Page 165: ... JAZZ DoseCoach 163 Pre clean Make sure JAZZ DoseCoach is turned off Before you clean and disinfect JAZZ DoseCoach and the lancing device pre clean the outside of JAZZ DoseCoach and the lancing device with a disinfecting wipe 1 ...

Page 166: ...Follow the instructions on the disinfecting wipe container label for safe handling of the wipes Wipe each side of JAZZ DoseCoach and the lancing device with moderate pressure using the following method a Wipe up and down three times b Wipe left and right three times 2 Avoid getting disinfectant inside the test strip port and the mini USB port ...

Page 167: ... let JAZZ DoseCoach and the lancing device air dry Wash your hands thoroughly with soap and water after handling JAZZ DoseCoach the lancet lancing device and test strips 3 2 mins If you have any questions about cleaning and disinfecting JAZZ DoseCoach or the lancing device call customer service at 0800 093 1812 ...

Page 168: ...ng device plastic housing or cracking of plastic housing display or buttons If JAZZ DoseCoach does not turn on If the lancing device does not work after cleaning and disinfecting In these cases call customer service at 0800 093 1812 Note The disinfection instructions in this section were validated for 260 cleaning and disinfecting cycles for a total of 520 wipes 260 cleaning wipes plus 260 disinfe...

Page 169: ... after JAZZ DoseCoach To help stop JAZZ DoseCoach from getting damaged always keep it in the carrying case when you are not using it Do not drop JAZZ DoseCoach If you think JAZZ DoseCoach may be damaged do not use it Call customer service at 0800 093 1812 ...

Page 170: ... to lose any data JAZZ DoseCoach also has an internal coin cell battery As long as this coin cell battery has not reached the end of its lifetime changing the batteries will not cause JAZZ DoseCoach to lose the clock time Slide open the battery door on the back of JAZZ DoseCoach 1 Change the batteries To remove the used primary non rechargable AA lithium batteries use a non metallic tool at the po...

Page 171: ...ection 7 Maintaining your JAZZ DoseCoach 169 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: ...nternal coin cell battery When this battery runs out Dose Helper will come to the end of its lifetime This battery should only be removed when JAZZ DoseCoach is ready to be discarded Remove the coin cell battery before discarding Slide open the battery door on the back of JAZZ DoseCoach Open the coin cell battery cover using a screwdriver and remove the coin cell battery Discard the battery accord...

Page 173: ... ANSWERS ON JAZZ DOSECOACH Section 8 Questions and answers on JAZZ DoseCoach 171 If you need further help after reading these instructions please contact your healthcare professional or call customer service at 0800 093 1812 ...

Page 174: ...ZZ DoseCoach may be damaged Call customer service at 0800 093 1812 When turning on JAZZ DoseCoach areas of the start up screen appear to be missing Compare your start up screen with the ones shown on page 29 Do not use JAZZ DoseCoach and call customer service at 0800 093 1812 if any areas of the start up screen appear to be missing Low battery warnings are shown soon after you change the batteries...

Page 175: ...se Dose Helper if turned on The history will fill automatically OR You may not have tagged your blood glucose readings Some of the history only show tagged blood glucose readings Use the tag function when measuring your blood glucose and the history will fill automatically OR The meter has been activated for a different type of insulin This would happen if you were given a different prescription b...

Page 176: ...Section 8 Questions and answers on JAZZ DoseCoach 174 This page has been left blank on purpose ...

Page 177: ...ood Glucose Meter messages 175 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: ...own or the other way around Remove the test strip from the strip port Reinsert the test strip with the black side up so the contact bars are inserted into the strip port see page 52 Ensure that the test strip is fully inserted OR Your test strip may be damaged Measure your blood glucose with a new test strip Check the expiration date of your test strips OR JAZZ DoseCoach may be damaged or blood or...

Page 179: ...ection gives information about the Blood Glucose Meter error messages If you see a message read it carefully and follow the instructions In certain cases JAZZ DoseCoach may return an error code or provide an inaccurate blood glucose reading if it is being used near electrical equipment like a power generator or a computer monitor If this is the case move JAZZ DoseCoach away from the source of elec...

Page 180: ... a new test strip see page 50 OR If this message appears during a test the test strip may have been removed too early Measure your blood glucose again with a new test strip see page 50 OR If this message appears after the calculation animation instead of a blood glucose reading it may mean that you applied more blood after testing began Measure your blood glucose again with a new test strip see pa...

Page 181: ...od glucose again with a new test strip Ensure that enough whole blood is applied to the test strip when measuring again see page 50 OR The sample may not be blood or control solution Measure your blood glucose again with a new test strip Make sure the test site is clean before measuring your blood glucose and that the control solution bottle tip is wiped clean before performing a control solution ...

Page 182: ...re your blood glucose again with a new test strip from a new vial of test strips OR The test strip may have been mishandled by vigorous bending or shaking Measure your blood glucose again with a new test strip see page 50 OR Parts of the test strip may have become covered in grease oil or lotion Measure your blood glucose again with a new test strip see page 50 OR The test strip port connector may...

Page 183: ...ptoms of hyperglycaemia contact your healthcare professional right away Measure your blood glucose again where it is closer to a room temperature of 21 C to 24 C If this error code persists on retesting contact your healthcare professional This may be caused by a non blood sample or a combination of high glucose and other medical conditions see page 39 Measure your blood glucose again OR If this e...

Page 184: ...glucose again in a warmer location OR If this error code persists on measuring again call customer service at 0800 093 1812 Have the JAZZ DoseCoach serial number located on the back of JAZZ DoseCoach available A problem has occurred related to the meter hardware Call customer service at 0800 093 1812 Have the JAZZ DoseCoach serial number located on the back of JAZZ DoseCoach available ...

Page 185: ...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 Have the JAZZ DoseCoach serial number located on the back of JAZZ DoseCoach available Move to an area with an ambient temperature of 10 C to 40 C Wait for JAZZ DoseCoach and test strips to reach the new temperature usually 10 to 20 minutes and measure a...

Page 186: ...lucose is measured after sleeping and before breakfast when you have not eaten or had a drink containing sugar glucose for at least 8 hours Your fasting blood glucose readings are used to decide if your insulin dose should be increased or decreased You have to tag or mark your readings when they are fasting Telling JAZZ DoseCoach which blood glucose readings are fasting is important for Dose Helpe...

Page 187: ...ut You can only use the fasting tag within three hours either side of your usual fasting time 1 Check if this is really a fasting blood glucose reading If not choose a different tag 2 Check if the fasting time fits your daily routine Change the fasting time settings if needed See page 140 for changing the usual tag times fasting and meal times ...

Page 188: ...treatment plan You had three or more hypos or low blood glucose readings in the last three weeks Contact your healthcare professional they may want to adjust your treatment plan Your recent fasting blood glucose readings were above the fasting blood glucose BG target range Use Dose Helper to get suggestions for adjusting your insulin glargine dose See page 99 for getting dose suggestions again See...

Page 189: ...ONS AND ANSWERS ON DOSE HELPER Section 10 Questions and answers on Dose Helper 187 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: ...do or what dose to take contact your doctor or nurse 2 If you will take a dose now run Dose Helper If Dose Helper is available within usual dose time range run through the Dose Helper steps as usual If Dose Helper is unavailable outside usual dose time range record this dose information Press Yes to the Record dose question to record a dose General questions and answers on Dose Helper 1 ...

Page 191: ...u ran Dose Helper and saved the dose but you forgot to take the suggested dose If you are not sure about what to do or what dose to take contact your doctor or nurse 2 If you will take a dose now run Dose Helper to record this dose information Press Yes to the Record dose question to record a dose 1 ...

Page 192: ...r but you are planning to take a dose that is different to the suggested dose for example because your doctor or nurse told you to Follow the steps on page 96 to enter the changed dose You have or have had hypo symptoms but Dose Helper is not available to report them If you are experiencing hypo symptoms now follow your treatment plan or contact your doctor or nurse right away 2 Run Dose Helper wh...

Page 193: ... you already took your dose The dose reminder goes off if you have not used Dose Helper to save a dose by then If you already took your dose but did not use Dose Helper do not run Dose Helper now Instead remember to run Dose Helper just before you take your next dose You will be able to enter any recent doses at this time 1 ...

Page 194: ...t already used Dose Helper to save a dose 1 Check if the usual dose time fits your daily routine Change the usual dose time settings if needed see page 148 2 Check if the dose reminder time fits your daily routine Change the dose reminder settings if needed see page 146 3 Check the clock time Change the clock settings if needed see page 137 Do 4 4 Take your dose at the usual time as instructed by ...

Page 195: ...head for sudden changes such as sick days You are planning to travel or to go on vacation to a different time zone Contact your doctor or nurse before you travel or go on vacation to get advice on how to manage your diabetes during this time Dose Helper cannot plan ahead for sudden changes such as travel and vacation When you arrive at your travel destination change the time and date on your JAZZ ...

Page 196: ...or activity If you are making significant changes to your diet or level of activity contact your doctor to get advice on how to manage your diabetes during this time Sudden changes in diet or your activity can cause changes in your blood glucose Dose Helper cannot plan ahead for sudden changes such as changes to your diet or activity ...

Page 197: ...oach is set correctly Set the clock to the correct local time if needed see page 137 2 Check if the usual dose time fits your daily routine Change the usual dose time settings if needed see page 148 3 If you decide to take a dose now use Dose Helper to save the dose you decide to take see page 90 If you are not sure what to do or what dose to take contact your doctor or nurse Do 4 4 Take your dose...

Page 198: ...o 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 Taking two doses too close together may cause low blood glucose 1 If you decide to take a dose now use Dose Helper to save the dose you decide to take see page 90 If you are not sure what to do or what dose to take contact your doctor or nurse ...

Page 199: ...ted three of the last four fasting blood glucose readings and the insulin dose that you took each day Dose Helper can still suggest increases if you missed measuring your fasting blood glucose on one day out of four as long as you entered your insulin dose for all days This may delay your treatment 1 To have enough information for a possible increase Measure your fasting blood glucose every day Us...

Page 200: ...ose to take contact your doctor or nurse 2 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 suggestions again on day 4 In these three days Measure your fasting blood glucose every day Run Dose Helper and enter your insulin glargine dose every day See page 99 for getting dose suggestions again Go to th...

Page 201: ...ause you have not collected enough fasting blood glucose BG readings or insulin doses Dose Helper needs a minimum 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 Dose Helper needs to gather new fasting blood glucose readings and insulin doses in order to give suggestions again ...

Page 202: ...ose because you took a dose outside the usual dose time If the usual dose time does not fit your daily routine you can change it in the settings menu Dose Helper needs to gather new fasting blood glucose readings and insulin doses in order to give suggestions again See page 148 for changing the usual dose time Do 4 4 Take your dose at the usual time as instructed by your doctor or nurse Contact yo...

Page 203: ...e suggestions again You changed the clock time and or your usual dose time significantly Dose Helper cannot suggest a dose because You changed your clock time by more than three hours OR You changed your usual dose time by more than three hours OR You changed your clock time and the usual dose time The combined change is more than three hours Dose Helper needs to gather new fasting blood glucose r...

Page 204: ... be at a consistent dose Dose Helper needs to gather new fasting blood glucose readings and insulin doses in order to give suggestions again Dose Helper cannot restart if you recently had low BG or hypo symptoms Dose Helper cannot restart because you recently had a low blood glucose BG reading less than 3 9 mmol L or you reported low blood glucose measured with another meter or hypo symptoms Dose ...

Page 205: ...glucose target range Dose Helper needs to gather new fasting blood glucose readings and insulin doses in order to give suggestions again Your recent taken doses have been consistently higher than suggested doses Talk to your doctor or nurse about continued use of Dose Helper The recent doses you entered into Dose Helper were too far above the dose that Dose Helper suggested Dose Helper needs to ga...

Page 206: ... suggestions see page 76 Dose Helper needs to gather new fasting blood glucose readings and insulin doses in order to give suggestions again Dose information was missing when the clock was changed This information cannot be interpreted You recently changed your clock time while some previous dose information was missing Missing doses or doses entered in the previous dose questions cannot be reliab...

Page 207: ...ion 10 Questions and answers on Dose Helper 205 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: ...urse may want to adjust your treatment You had frequent low BG You had three or more hypos or blood glucose BG readings less than 3 9 mmol L in the last three weeks Your doctor or nurse may want to adjust your treatment Your dose is low Your suggested dose has gone below a minimum number of units Your doctor or nurse may want to adjust your treatment Your fasting BG is not decreasing as expected Y...

Page 209: ...uggest for you Dose Helper will stop suggesting doses when you reach the maximum dose limit Your doctor or nurse may want to adjust your treatment You may need a dose reduction but Dose Helper does not have enough information You had a blood glucose reading less than 3 9 mmol L or you reported low blood glucose measured with another meter or hypo symptoms Your doctor may want to adjust your treatm...

Page 210: ...ings When you see a Dose Helper off warning do the following 1 If you are not sure about what to do or what dose to take contact your doctor or nurse 2 To use Dose Helper it must be turned on by your doctor or nurse Go to the Next screen Then press OK to confirm the warning ...

Page 211: ... a dose suggestion in the last 30 days Dose Helper activation has expired 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 You reached the maximum dose amount You reached the maximum dose that was set by your doctor or nurse Contact your doctor or nurse Your dose ...

Page 212: ... is only for use with once daily insulin glargine You indicated to Dose Helper that you switched to multiple dosing Dose Helper can only be used with insulin glargine taken once daily Contact your doctor or nurse There was a problem while using Dose Helper Dose Helper was disabled JAZZ DoseCoach may have lost power or it may have been dropped Contact your doctor or nurse ...

Page 213: ...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 If you get additional warnings please find them in this questions and answers section ...

Page 214: ... to enter missing hypo or dose information you should restart Dose Helper Press OK to continue in Dose Helper Press Exit to leave Dose Helper Use to restart Dose Helper Dose Helper will start from the beginning and allow you to add information for example hypos or previous doses You cannot change or delete information that you saved before If you are not sure about what dose to take contact your d...

Page 215: ...atment plan After this period Dose Helper activation expires It can be renewed by your doctor or nurse JAZZ DoseCoach has an internal coin cell battery This battery will run empty shortly Dose Helper will expire then and can no longer be used or activated JAZZ DoseCoach can continue to be used for measuring blood glucose Talk to your doctor or nurse about getting a new JAZZ DoseCoach ...

Page 216: ...s 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 measuring blood glucose Talk to your doctor or nurse about getting a new JAZZ DoseCoach ...

Page 217: ...ting 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 When using Dose Helper and saving doses the in fasting blood glucose target star will be shown instead of the shooting star The star is filled when the most recent pair dose fasting blood glucose has be...

Page 218: ...6 What happened What this means Your recent fasting blood glucose BG readings were above the fasting blood glucose target range 1 Use Dose Helper to get suggestions for adjusting your insulin glargine dose See page 99 for getting dose suggestions again ...

Page 219: ...Z DOSECOACH SPECIFICATIONS Section 11 JAZZ DoseCoach specifications 217 If you need further help after reading these instructions please contact your healthcare professional or call customer service at 0800 093 1812 ...

Page 220: ...ds Measurement units mmol L Result range 1 1 to 33 3 mmol L Haematocrit 20 to 60 Operating relative humidity 25 to 90 Operating temperature 10 C to 40 C Control solution storage temperature 2 C to 30 C Test strip storage temperature 8 C to 30 C Dose reminder programmable alarm Power source two replaceable primary AA lithium batteries and one non replaceable coin cell battery If the coin cell batte...

Page 221: ...ng electromagnetic fields When using JAZZ DoseCoach keep away from sources of electromagnetic disturbances such as electric motors mobile phones computer monitors or radio transmitting equipment JAZZ DoseCoach should not affect the normal operation of other devices If this does occur provide more distance between JAZZ DoseCoach and the affected device SEGGER is a licensor of the JAZZ DoseCoach sof...

Page 222: ...inger 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 5 5 mmol L Within 5 Within 10 Within 15 200 420 47 6 351 420 83 6 401 420 95 5 ...

Page 223: ...r 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: ...ol solution in the laboratory Repeatability Within Run Blood Level 1 Level 2 Level 3 Level 4 Level 5 Average mmol L 2 0 4 9 7 0 12 4 21 4 SD mmol L 0 13 0 18 0 20 0 32 0 62 CV N A 3 7 2 8 2 6 2 9 Intermediate precision Day to Day Control Low Level 1 Normal Level 2 High Level 4 Average mmol L 3 1 7 2 17 7 SD mmol L 0 11 0 24 0 72 CV N A 3 3 4 1 ...

Page 225: ...ues 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: ...r a unique number that belongs to your JAZZ DoseCoach Manufacturer In Vitro Diagnostic Medical Device Batch code Consult instructions for use Do not reuse Temperature limitation store at a temperature above 8 C and below 30 C Use by Catalogue number European Authorised Representative ...

Page 227: ...Section 11 JAZZ DoseCoach specifications 225 This page has been left blank on purpose ...

Page 228: ...8100 10395 Rev A ...

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