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MiniMed™ 640G System User Guide RELEASED

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1. 5 le MP6025957 024 A Showing the effects that your diet exercise and medication can have on your glucose levels e Giving you additional tools to help you prevent high and low glucose levels P Note If you lose sensor functionality you will no longer have access to CGM features For details on restoring sensor functionality see Troubleshooting sensor issues on page 234 To learn more about the accuracy of sensor glucose SG readings versus blood glucose BG meter readings see Enlite Sensor Performance for the MiniMed 640G Insulin Pump SmartGuard SmartGuard is a feature that can automatically stop and resume insulin delivery based on your sensor glucose values and low limit Your low limit should be set based on recommendations from your healthcare professional When a SmartGuard suspend by sensor event occurs basal insulin delivery automatically resumes if your sensor glucose values are rising and have met the specified criteria or if the maximum suspend time of two hours is reached The following table shows the different SmartGuard settings you can use and where to find out more information To learn more about Go to this section How to use SmartGuard to automatically suspend Suspend before low on page 158 your insulin delivery before you reach your low limit How to use SmartGuard to automatically suspend Suspend on low on page 161 your insulin delivery when you reach your
2. A feature that allows you to set up and save temporary basal rates for repeated use An alert that notifies you if your sensor glucose value has been rising or falling faster than the Rise Limit or Fall Limit that you have set A type of notification that you can set to help you remember to do something The small container that you fill with insulin and insert into your delivery device An alert that can be set to occur when your pump has automatically resumed basal insulin delivery after a Suspend before low or Suspend on low event because your sensor glucose values have met the necessary criteria This alert will always occur if basal insulin delivery has resumed because the two hour maximum suspend time has elapsed Glossary 281 ED c u un 0 lt MP6025957 024 A Rewind sensitivity sensor glucose sensor sensor glucose SG Set Change reminder SG Sleep mode SmartGuard Square Wave Bolus Suspend before low Suspend Delivery Suspend on low Temp Basal Rate temporary basal rate transfer guard 282 Glossary A feature used when changing a reservoir It returns the piston to its starting position and allows a new reservoir to be placed into the pump See insulin sensitivity factor The small part of the continuous glucose monitoring system that you insert just below your skin to measure glucose levels in your interstitial fluid Refers to glucose sugar that
3. Brasil Medtronic Comercial Ltda Tel 11 2182 9200 Medtronic Directo 24 7 0800 773 9200 Bulgaria Interagro 90 Ltd Tel 359 888 636 033 Canada Medtronic of Canada Ltd Tel 1 800 284 4416 toll free sans frais Chile Medtronic Chile Tel 9 66 29 7126 Medtronic Directo 24 7 1 230 020 9750 Medtronic Directo 24 7 From Santiago 2 595 2942 China Medtronic Shanghai Ltd 24 Hour Help Cell 4 86 400 820 1981 24 Hour Help Landline 86 800 820 1981 Colombia Medtronic Latin America Inc Sucursal Colombia Tel 1 742 7300 Medtronic Directo 24 7 Landline 01 800 710 2170 Medtronic Directo 24 7 Cellular 1 381 4902 Croatia Oktal Pharma Tel 385 1 659 57 77 Croatia Medtronic Adriatic doo Tel 385 1 488 11 20 Fax 385 1 484 40 60 Danmark Medtronic Danmark A S Tel 45 32 48 18 00 Deutschland Medtronic GmbH Gesch ftsbereich Diabetes Telefon 49 2159 8149 370 Telefax 49 2159 8149 110 24 Stdn Hotline 0800 6464633 Eire Accu Science LTD Tel 353 45 433000 Espana Medtronic Ib rica SA Tel 34 91625 05x42 Fax 3491 625 03 90 24 horas 34900 120 330 Europe Medtronic Europe SA Europe Middle East and Africa Headquarters Tel 41 0 21 802 7000 France Medtronic France SAS Tel 33 0 1 55 38 17 00 Hellas Medtronic Hellas S A Tel 30 210677 9099 Hong Kong Medtronic International Ltd Tel 852 2919 1300 To order supplies 852 2919 1322 24 hour
4. Responding to a Suspend on low event When you clear the Suspend on low alarm the SmartGuard suspend by sensor icon flashes and Suspended on low appears on your Home screen When a Suspend on low event occurs the pump alerts you When a Suspend on low event occurs insulin delivery remains suspended for at least 30 minutes unless you manually resume your basal delivery For details see Manually resuming basal delivery during a suspend by sensor event on page 174 After the minimum 30 minute suspend time basal insulin delivery will automatically resume if the following conditions are met Your SG is at least 1 1 mmol L above your low limit Your SG is estimated to be more than 2 2 mmol L above your low limit within 30 minutes Your basal insulin delivery will be suspended for a maximum of two hours unless these criteria are met during the suspend or unless you manually resume your basal insulin For details see Manually resuming basal delivery during a suspend by sensor event on page 174 If you do not respond to the Suspend on low alarm your pump resumes insulin delivery after two hours and continues to display an emergency message 162 Chapter 10 MP6025957 024 A When Suspend on low is unavailable After a Suspend on low event occurs there is a period of time when the suspend functionality is unavailable This time will vary depending on whether or not you respond to the Suspend on low event You can ma
5. write down the error code displayed on the alarm screen you can also find it in your Alarm History and contact your local representative for assistance with your pump Select OK to clear the alert e Replace the AA battery Alarms alerts and messages 213 EY s 2 D et di gt 3 D N M MP6025957 024 A Title and text Replace battery now Delivery stopped Battery must be replaced to resume delivery Reservoir estimate at O U To ensure insulin delivery change reservoir Resume bolus XXX of YYY U delivered Resume delivery of 222 9 Resume Dual bolus XX of YY U delivered Resume delivery of ZZ U for XXX hr 214 Chapter 12 Explanation Insulin delivery has stopped due to low power Battery was not replaced after the Low battery Pump alert Your reservoir level is estimated at O units A normal bolus delivery has been interrupted because the pump battery was removed If it is within 10 minutes since this interruption you can resume this bolus Me Square portion of Dual Bolus delivery has been interrupted If it is within 10 minutes since this interruption you can resume this bolus Next steps Replace the battery immediately to resume insulin delivery For details see Removing the battery on page 23 Select OK to clear the alert e Change the reservoir now e Check the message to see how much of
6. MP6025957 024 A appendix a end user software license agreement MP6025957 024 A MP6025957 024 A End user software license agreement End user software license agreement NOTICE TO USER Certain portions of software contained in this product may be covered by the GNU General Public License Version 2 or Version 3 Open Source which can be obtained through the GNU web site at www gnu org copyleft gpl html The source code for any Open Source can be obtained for a nominal fee to cover the cost of shipping and media by contacting Medtronic MiniMed Inc Director of Software Development 18000 Devonshire Street Northridge CA 91325 1219 USA tel 1 866 948 6633 x b x Y M o N M un le y A M un b O b D 5 et End user software license agreement 273 MP6025957 024 A 2 4 Appendix A MP6025957 024 A 50 6 MP6025957 024 A MP6025957 024 A Glossary active insulin active insulin adjustment Active Insulin Time Activity Guard Airplane Mode alarm Alarm History alert Alert before low Alert Limits Bolus insulin that has been delivered by the pump and is still working to lower your blood glucose levels The amount of insulin that is subtracted from your BG correction bolus to account for the active insulin that is tracked by the Bolus Wizard A Bolus Wizard setting t
7. e Consider delivering remaining EY s 2 D et di gt 3 D N M un bolus if the bolus insulin was not included in an insulin injection Alarms alerts and messages 207 MP6025957 024 A Title and text Insulin flow blocked Fill Cannula stopped Remove infusion set from body Change reservoir and infusion set 208 Chapter 12 Explanation Your pump has detected the insulin flow was blocked while filling the cannula Next steps e Check your blood glucose Consider checking ketones and take an injection if needed e Remove your infusion set and reservoir Select Rewind to start the new reservoir process using a new infusion set and reservoir If a fill cannula was in progress when the alarm occurred e Check the Daily History screen for the amount of bolus already delivered before the pump alarmed e Consider delivering remaining bolus if the bolus insulin was not included in an insulin injection MP6025957 024 A Title and text Insulin flow blocked Fill Tubing stopped Remove reservoir and select Rewind to restart Loading incomplete Remove reservoir and select Rewind to restart loading Low battery Pump Replace battery soon Explanation Your pump has detected the insulin flow was blocked while filling the tubing Possible connection issue between the tubing and reservoir You pressed amp after lo
8. Cordless Household TDMA 50 Hz cell phone TDMA 50 Hz cell phone PCS cell phone DCS cell phone 1 8 MHz 1 CDMA cell phone 1 9 MHZ WiFi Networks Lo 5 je Q c A et N Lo D A e A 0 Uu 0 Q N et lt O 3 0 O Product specifications and safety information 267 MP6025957 024 A Recommended separation distances between portable and mobile RF communications equipment and the MiniMed 640G insulin pump The insulin pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the MiniMed insulin pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the MiniMed insulin pump as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to the frequency of power of transmitter W transmitter m 80 MHz to 800 MHz 800 MHz to 6 GHz For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note At 80 MHz and 800 MHz the separation distanc
9. E un e o N M 3 o zi le 5 MP6025957 024 A Historical sensor glucose readings for the last 3 hour 6 hour 12 hour or 24 hour periods Your high and low glucose alert limit The bolus deliveries you have given during the time period shown on the graph Any suspend events that have occurred If an SG reading does not appear on the graph some possible reasons for this include An error condition or a sensor related alert is occurring A new sensor that you just inserted is still initializing A new sensor that just initialized is still calibrating An existing sensor that you have recently reconnected is not ready More than six hours have passed since the initial sensor calibration More than 12 hours have passed since the last sensor calibration To view the sensor graph 1 Select the graph area of the Home screen A full screen view ofthe 3 hour graph appears 2 Select to navigate to the 6 hour 12 hour and 24 hour graphs 3 Select lt to view SG readings and event details 4 To exit the full screen view press Identifying rapid changes in sensor glucose When you use a sensor trend arrows appear on the Home screen if your SG has been rising or falling faster than a certain per minute rate The number of arrows that appear tell you how quickly your SG has been changing The following table shows the trend arrows and their corresponding rates SG has been rising at a rate of
10. Max Basal Rate Basal patterns Adding a new basal pattern Editing copying or deleting a basal pattern Changing from one basal pattern to another Temporary basal rates About Temp Basal rates Starting a Temp Basal rate Preset Temp basal rates Canceling a Temp Basal or Preset Temp basal rate Viewing your basal information Stopping and resuming your insulin delivery About bolus deliveries Bolus types Bolus type example Bolus delivery options Contents MP6025957 024 A 62 O9 64 64 65 65 66 69 71 72 2 29 4 5 76 77 77 79 9 80 80 82 83 83 94 94 86 86 88 88 Bolus settings Max Bolus Bolus Increment Bolus Speed Bolus Wizard Understanding your Bolus Wizard settings Setting up the Bolus Wizard feature Changing your Bolus Wizard settings Turning off the Bolus Wizard feature About active insulin Bolus Wizard warnings Normal bolus Delivering a Normal bolus with the Bolus Wizard Delivering a Normal bolus using Manual Bolus Square Wave bolus Turning on or off Square Wave bolus Delivering a Square Wave bolus with the Bolus Wizard Delivering a Square Wave bolus using Manual Bolus Dual Wave bolus Turning on or off Dual Wave bolus Delivering a Dual Wave bolus with the Bolus Wizard Delivering a Dual Wave Bolus using Manual Bolus Easy Bolus Understanding Easy Bolus step sizes Setting up Easy Bolus Delivering a bolus using Easy Bolus Preset Bolus Setting up and managing Preset
11. Note f you change your bolus amount the word Modified appears next to the new bolus amount Select Next to review your bolus information Select Dual The Bolus Wizard screen appears with the food amount split evenly between the Now and Square portions If you need to change the amounts select the area of the screen with the Now value and adjust the Now amount When you adjust the Now amount the Square amount adjusts automatically Bolus Wizard 03 05 Bolus 2 60 Now 21 0 7 u 73 1 9u 3 00 nr oquare Duration Adjust the Duration over which you want the Square Wave portion to be delivered The duration can be from 30 minutes to 8 hours Select Deliver Bolus to start your bolus During a Dual Wave delivery the Home screen shows the progress of the Now portion of your delivery When the Now portion is complete the Bolus button on your Home screen appears as Bolus D You can select Bolus D Bolus 8 MP6025957 024 A to stop the bolus to see details on the amount of bolus insulin delivered or to access the Bolus menu The Bolus menu provides access to the Bolus Wizard Manual Bolus Preset Bolus and Insulin Settings options Delivering a Dual Wave Bolus using Manual Bolus The Dual Wave option is available in the Manual Bolus screen only after you turn on the Dual Wave feature To deliver a Dual Wave bolus using Manual Bolus 1 82 Go to the Manual Bolus screen Home screen gt
12. T 2 mmol L Active Ins adjust Carbs 35 If you want to change the bolus amount select Bolus and make any desired adjustment If you change your bolus amount the word Modified appears next to the new bolus amount 6 Select Next to review your bolus information Your bolus amount appears 2 Note If you modified your bolus amount in the previous step Bolus Calculated displays your original bolus amount Modification displays the amount you added or subtracted from your bolus and Bolus displays the actual bolus amount Bolus Wizard Bolus Select Deliver Bolus to start your bolus Your pump beeps or vibrates and displays a message when your bolus starts The Home screen shows your bolus amount as it is being delivered Your pump beeps or vibrates when your bolus is complete Delivering a Normal bolus using Manual Bolus The following section describes how to deliver a Normal bolus using the Manual Bolus feature Bolus 75 MP6025957 024 A To deliver a Normal bolus using Manual Bolus 1 Goto the Manual Bolus screen Home screen Bolus Manual Bolus Note If the Bolus Wizard is turned off the Manual Bolus screen A appears when you select Bolus Manual Bolus 08 01 BG a e Active Insulin 0 0u Deliver Bolus The Manual Bolus screen shows your current BG value if applicable and any insulin that is still active from previous boluses For more information about active insu
13. A gt Note When you enter your settings you first define the time segment and then select the high settings you want on during that time segment To set up the High Settings le 168 Go to the High Settings screen Menu gt Sensor Settings gt High Settings The High Settings screen appears High Settings Select High Settings to turn on the feature The High Setup screen appears High Setup Start End Hi mmol L 00 00 24 00 Select the time segment The End time starts flashing The Start time of the first time segment is always 00 00 You can set up to eight time segments each with a different high limit If you set more than one time segment the time segments must cover a 24 hour period Set the End time Set your Hi limit You can enter a value from 5 6 to 22 2 mmol L in increments of 0 2 mmol L Select the arrow to the right of the End time to select the high settings for this time segment Chapter 10 MP6025957 024 A A screen appears showing the high alerts for the selected time segment 00 00 24 00 13 8 mmo Off i Alert on high Rise Alert Next Set the following alerts as desired a Select Alert before high if you want to receive an alert before you reach your high limit If you turned on Alert before high enter the Time before high to set how soon you want to be alerted before reaching your high limit You can enter a value from 5 to 30 minutes C Select Aler
14. A Basal Basal insulin is the background insulin that you need throughout the day and night to maintain your target blood glucose values when you are not eating Your basal insulin accounts for approximately one half of your daily insulin requirements Your pump mimics a pancreas by delivering insulin continuously over 24 hours Your basal insulin is delivered according to a basal pattern Basal patterns and other basal settings are described in the following sections Basal rate Your basal rate is the specific amount of basal insulin that your pump continuously delivers each hour While some people use one basal rate all day others require different rates at different times of the day Your basal rates are set in one or more basal patterns Each basal pattern covers 24 hours For specific information about basal patterns see Basal patterns on page 41 Basal 39 MP6025957 024 A Basal insulin settings Your basal insulin delivery settings are described in the following table Setting Basal Pattern Temp Basal Preset Temp Max Basal Rate 40 Chapter 3 What it is A set of one or more basal rates that cover a 24 hour period A basal rate that you use in place of your scheduled basal rate for short term situations A temporary basal rate that you can define ahead of time Maximum amount of basal insulin that your pump can deliver per hour What it does for you Determines the amount of
15. BG meter readings 119 bolus 118 Index 295 MP6025957 024 A overview 118 U total carbs 118 total daily dose 118 viewing 117 supplies ordering 15 unavailable Suspend before low 160 Suspend on low 163 unlocking 26 Suspend before low utilities 33 about 158 examples 165 166 V unavailable 160 suspend by sensor viewing history pump settings 145 icon 155 Suspend on low W about 161 wireless connection examples 166 automatic 175 unavailable 163 failure 179 suspended delivery resuming automatically 164 manually 54 174 suspending insulin delivery 54 139 158 161 manual 179 T temp basal rate about 47 percent 47 preset 40 rate 47 starting 48 types 47 Time before high SG setting 157 time current changing 148 transmitter communication 29 connecting pump 175 179 deleting from pump 181 signal alert 220 Transmitter battery depleted alert 225 trend arrows 192 troubleshooting 229 tubing filling 101 image 19 Max Fill reached alarm 210 211 296 Index MP6025957 024 A MP6025957 024 A 298 Index MP6025957 024 A MP6025957 024 A Medironic est Medtronic MiniMed 18000 Devonshire Street Northridge CA 91325 USA 800 646 4633 818 576 5555 REP Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands 6025957 024 a MP6025957 MiniMed 640G
16. Bolus gt Manual Bolus The Manual Bolus screen appears Set your bolus delivery amount in units and then select Next Select Dual The Manual Bolus screen appears with the Now and Square portions split evenly 4 0u 4 0u 0 30 nr If you need to change the amounts select the area of the screen with the Now value and adjust the Now amount When you adjust the Now amount the Square amount adjusts automatically Adjust the Duration over which you want the Square Wave portion to be delivered The duration can be from 30 minutes to 8 hours Select Deliver Bolus to start your bolus During a Dual Wave delivery the Home screen shows the progress of the Now portion of your delivery When the Now portion is complete the Bolus button on your Home screen appears as Bolus D You can select Bolus D Chapter 4 MP6025957 024 A to stop the bolus to see details on the amount of bolus insulin delivered or to access the Bolus menu The Bolus menu provides access to the Bolus Wizard Manual Bolus Preset Bolus and Insulin Settings options Easy Bolus The Easy Bolus feature allows you to quickly deliver a Normal bolus using only the A button Your pump must be in sleep mode to use the Easy Bolus feature Before using Easy Bolus you must turn on the feature and set the step size The step size determines the number of units the bolus amount increases each time you press the A button Your Easy Bolus delivery is limited to 20
17. How to enter your calibration BG Enter a BG meter reading specifically for calibration Enter a BG meter reading specifically for calibration Select the Calibrate Sensor option to calibrate your sensor with the current BG meter readings When you enter a BG meter reading in Event Markers the Event Markers screen has an option to use the BG value for calibration When you enter a BG meter reading to deliver a bolus using the Bolus Wizard the Bolus Wizard gives you the option to use the BG value for calibration after the bolus is delivered The following table describes when to calibrate your sensor Do your first sensor calibration Your pump displays a Calibrate now alert within two hours after starting a new sensor Your first sensor glucose reading appears about 5 to 15 minutes after you calibrate 186 Chapter 10 MP6025957 024 A Calibrate Description Six hours after your Do your second sensor calibration first calibration Six hours after you calibrate for the first time a Calibrate now alert appears and your pump stops calculating your SG values It takes about 5 to 15 minutes after you calibrate to receive SG values again Within 12 hours after After you do your second calibration you need to calibrate at your second least every 12 hours calibration and at If you do not calibrate for more than 12 hours a Calibrate now least every 12 hours alert appears It takes about 5 to 15 minutes aft
18. Product specifications and safety information 265 MP6025957 024 A Guidance and Manufacturer s Declaration Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the MiniMed insulin pump is used exceeds the applicable RF compliance level above the insulin pump should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the MiniMed insulin pump POver the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m 266 Chapter 15 MP6025957 024 A Recommended separation distances between the MiniMed 640G insulin pump and common household radio transmitters Household RF Frequency Recommended Recommended Transmitter Separation Separation Distance meter Distance inch Telephones Cordless Household 2 4 GHz
19. The Summary screen separates information into five categories overview bolus BG meter sensor SmartGuard Summary screen overview The following table describes the overview portion of the Summary screen 4 Note If you are viewing a single day of Summary results then the values shown are the actual results for the selected day If you are viewing more than one day of Summary results then the value is an average of the days that you selected Name Description TDD Total daily dose of insulin units Basal e Insulin units devoted to basal delivery e Percentage of insulin devoted to basal delivery Bolus e Insulin units devoted to bolus delivery e Percentage of insulin devoted to bolus delivery Total Carbs Daily carbohydrate amount in grams or exchanges Summary screen bolus The following table describes the bolus portion of the Summary screen 118 Chapter 7 MP6025957 024 A P Note If you are viewing a single day of Summary results then the values shown the actual results for the selected day If you are viewing more than one day of Summary results then the value is an average of the days that you selected Name Description Carb bolus only e Total insulin units delivered using the Bolus Wizard with food E amount only Number of times the Bolus Wizard delivered a food bolus un O only lt CU BG Correction only e Total insulin units delivered using the Bolus Wizard with BG zl correcti
20. active insulin tracked prior to pump restart is not included in new Bolus Wizard calculations Consult your healthcare professional for how long you need to wait after active insulin is cleared before you can rely on the active insulin calculation of your Bolus Wizard e You can check Daily History for the time and amount of your last bolus For more information see Daily History on page 121 To clear the alarm and resume basal insulin delivery select Resume Basal e Check your BG and treat as necessary Select OK to clear the alarm e Remove the old battery and insert a new AA battery For details see About batteries on page 21 To clear the alarm remove the incompatible battery Insert a new AA battery For compatible battery types see About batteries on page 21 Alarms alerts and messages 203 EY s 2 D et di gt 3 D N M MP6025957 024 A Title and text Bolus not delivered Bolus entry timed out before delivery If bolus intended enter values again Bolus stopped Cannot resume bolus or cannula fill XX XXX of YY YYY U delivered 77 227 U not delivered If needed enter values again Cannot connect device This device is incompatible with your pump See User Guide Check settings Startup Wizard settings complete Check and set up your other settings 204 Chapter 12 Explanation Bolus value
21. basal rate for the duration you set When the duration is complete your basal insulin automatically returns to the active basal pattern To start a temp basal rate 48 Go to the Temp Basal screen Home screen Basal Temp Basal Duration is flashing Set the Duration for this temp basal rate The Duration can be set from 30 minutes to 24 hours in 15 minute increments Temp Basal 16 27 Current rate 0 050 uhr Select Next The Type defaults to Percent You can switch between Percent and Rate by selecting Type Temp Basal 10 28 Current rate 0 050 U hr Type Rate Percent Review Begin Chapter 3 MP6025957 024 A 5 Depending on the Type you selected do one of the following Enter a percentage Current rate 0 050 U hr Type Rate Percent Review Begin Enter a basal rate making sure you do not exceed your max basal rate emp Basal 19 25 Current rate 0 050 U hr Type Rate Percent Review Begin 6 If desired select Review to review your temp basal setting Select Begin to start the temp basal rate Your Temp Basal rate continues for the duration you set The Basal option on the Home screen appears as Basal T during your temp basal delivery Your scheduled basal rate automatically starts again when your Temp Basal rate finishes J Note If you need to cancel your temp basal select Basal T from the Home screen then select Cancel Temp Basal Pres
22. pump settings viewing 145 summary 117 Home Screen about 26 active insulin amount 26 basal delivery 26 blood glucose reading 26 bolus delivery 26 CGM with 153 display 21 sensor glucose 153 sensor glucose reading 153 sensor graph 153 sensor status icons 153 status bar 26 time 26 trend arrows 153 icons Home Screen 28 sensor status 153 SmartGuard 155 160 163 suspend by sensor 155 infusion set about 93 best insertion sites 103 disconnect Quick set 107 fill cannula alarm 205 fill tubing 101 inserting 103 reconnect Quick set 107 reservoir alarm 209 reservoir and tubing 33 reservoir removal 93 rotating sites 104 setting up 93 type 13 Insert battery alarm 205 inserting infusion set 103 reservoir 99 sensor 182 insulin basal 39 basal patterns 41 bolus 59 flow blocked alarm 206 207 208 209 icon 29 Max Fill reached alarm 210 211 settings 33 insulin delivery Block Mode 139 resuming 54 164 174 stopping 54 88 suspending 54 139 158 161 Insulin flow blocked alarm 206 207 208 209 Insulin Sensitivity Factor about 66 setting up 70 ISIG view 124 L language changing 141 starting 24 light red 201 Loading incomplete alarm 209 Lost sensor signal alert 221 Low battery Pump alert 209 Low battery transmitter alert 221 Low BG Bolus Wizard warning 73 Low limit 158 Low Reservoir alert 132 210 reminder 132 Index 291 MP6025957 024 A Low Settings
23. 0 056 mmol L per minute or more but less than 0 111 mmol L per minute v SG has been falling at a rate of 0 056 mmol L per minute or more but less than 0 111 mmol L per minute 192 Chapter 11 MP6025957 024 A SG has been rising at a rate of 0 111 mmol L per minute or more but less than 0 167 mmol L per minute way SG has been falling at a rate of 0 111 mmol L per minute or more but less than 0 167 mmol L per minute SG has been rising at a rate of 0 167 mmol L minute or more MEME SG has been falling at a rate of 0 167 mmol L per minute or more Silencing Glucose Alerts The Alert Silence feature allows you to make sensor glucose alerts silent for a set period of time This is useful in situations where you do not want to disturb others such as when you are in a business meeting or in a movie theater When using this feature your system still records the time and glucose value for any alerts that occur You can view this information in the Alarm History screen See Alarm History on page 122 for details If a glucose alert occurs when you are using the Alert Silence feature the notification light begins to flash and the Sensor alert occurred message appears letting you know an alert was silenced but there is no vibration or beep If you have not cleared the alert by the end of the preset alert silence duration your pump begins to beep or vibrate periodically until the alert is cleared The following
24. 0 to 7 8 mmol L a message appears asking you to confirm your setting 4 When you have made your changes select Save Changing your Active Insulin Time The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus Your healthcare professional will prescribe the active insulin time that is best for you To change your active insulin time 1 Go to the Active Insulin Time screen Menu Insulin Settings Bolus Wizard Setup Active Insulin Time 2 Select Duration then adjust your active insulin time in hours using 15 minute increments 3 Select Save Turning off the Bolus Wizard feature You can turn off the Bolus Wizard feature at any time Your Bolus Wizard settings remain in your pump When the Bolus Wizard is turned off the Bolus Wizard option does not appear in the Bolus Menu and you cannot edit your Carb Ratio Insulin Sensitivity Factor or BG Target settings from the Bolus Wizard Setup screen To turn off the Bolus Wizard feature 1 Go to the Bolus Wizard Setup screen Menu Insulin Settings Bolus Wizard Setup Bolus 71 MP6025957 024 A 2 Select Bolus Wizard to turn the feature off About active insulin Active insulin is the bolus insulin that has already been delivered to your body and is still working to lower your blood glucose levels The pump considers your active insulin time set
25. 181 un M er er 5 e E o A 3 er 5 c un c A un b 5 perit le 5 e MP6025957 024 A Identify and select your transmitter by the serial number The serial number can be found on the back of the transmitter Medtronic Guardian Link REF MMT 7763A FCC ID XXXXXXX IC XXXXX XXXX Select Delete A screen appears confirming that you would like to delete the device Select Yes to confirm or No to cancel Inserting the sensor Always refer to the serter user guide for instructions on how to insert the sensor Connecting the transmitter to the sensor Always refer to your transmitter user guide for instructions on connecting the transmitter to the sensor Starting the sensor After you insert your sensor and connect your sensor and transmitter your pump starts communicating with the transmitter The pump notifies you when the sensor is ready to use To start a new sensor using the Start New Sensor message I 182 Select Start New Sensor when it appears on the pump screen The Sensor warm up started message appears Select OK Warm up appears on the Home screen until the sensor is ready for first calibration Note If you do not see the Start New Sensor option then follow the procedure for manual connection described below Chapter 10 MP6025957 024 A To start a new sensor using manual connect is Go to the Sensor Connections
26. 215 resuming suspended delivery 54 164 174 return to previous screen 21 RE communications 267 268 Rise Alert responding to 223 5G setting 157 summary screen 120 Rise Limit SG setting 157 S saving power 34 pump settings 142 screen Active Insulin Time 71 Airplane Mode 138 Alarm History 122 Audio Options 139 Auto Suspend 139 Basal Pattern Setup 46 BG Check 130 BG Target 71 Block Mode 140 Bolus Increment 64 Bolus Speed 64 Bolus Wizard Setup 67 71 Carb Ratio 70 Carb Unit 140 Display Options 141 Dual Square Wave 77 Easy Bolus 84 Enter Date Screen 25 Enter Time 25 Event Markers 124 Exchange Ratio 70 Fill Cannula 106 Fill Tubing 102 Home Screen 26 153 Language 24 141 Low Reservoir 133 294 Index Manual bolus 76 Max Bolus 63 Missed Meal Bolus 131 New Reservoir 95 Personal reminder 129 Preset Bolus Setup 87 Preset Temp Setup 50 Select Time Format 24 Self Test 146 Sensitivity 70 sensor Demo 147 Sensor Glucose Review 122 sensor Settings 167 Set Change 133 summary 117 Suspend Delivery 54 Temp Basal 48 Time and Date 148 Welcome screen 24 scroll bar 21 34 select 21 sensor airplane mode 137 alarms 216 alerts 216 BG not received alert 218 calibrating 184 187 calibration alert 219 calibration icon 30 connecting transmitter 182 disconnecting transmitter 188 expired alert 224 feature turning off 188 feature turning on 167 graph 153 inserting 182 life icon 30 messages 216 pair 175 179 removi
27. Bolus A bolus is the amount of insulin taken to cover an expected rise in blood glucose typically when you eat a meal or snack You can also use a bolus to correct a high blood glucose reading About bolus deliveries There are different types of bolus deliveries you can use depending on your insulin needs at the time There are also different ways you can deliver a bolus Discuss these options with your healthcare professional to determine what is best for you Bolus types The following table provides general information about the available bolus types Type How it works When to use it Normal Provides a single This is the typical bolus type you use to immediate dose of cover your food intake or to correct a high insulin BG meter reading For details about using the Normal bolus feature see Normal bolus on page 73 Bolus 59 MP6025957 024 A Type How it works When to use it Square Delivers a single bolus You might use a Square Wave bolus Wave evenly over an extended If you have delayed food digestion due to period of time gastroparesis or meals high in fat 30 minutes to 8 hours e When snacking over an extended period of time e Normal bolus drops your blood glucose too rapidly For details about using the Square Wave bolus feature see Square Wave bolus on page 76 Dual Delivers a combination You might use a Dual Wave bolus Wave of an immediate Normal When you eat meals that are bo
28. Bolus Wizard settings e Carb ratio or Exchange ratio e Insulin sensitivity factor BG target To enter your pump settings 1 Begin entering your settings by selecting your language Click Next to go to each new screen 2 When the Select Time Format screen appears select a 12 hour or a 24 hour time format et le a Uu gt je je et le 3 When the Enter Time screen appears adjust the setting to the current time If you are using a 12 hour clock be sure to specify AM or PM 4 When the Enter Date screen appears adjust the Year Month and Day to the current date 5 When the Select Carb Unit screen appears select Grams or Exchanges as the unit your pump uses to display carbohydrate information 6 When the Active Insulin Time screen appears enter the Duration For details see About active insulin on page 72 Enter your first basal rate by entering the End time and the Rate You can enter more basal patterns after you complete the startup wizard For details see Adding a new basal pattern on page 42 After you complete your basal pattern a screen appears to allow you to review your basal information 8 When the message appears asking if you want to setup the Bolus Wizard settings do one of the following Select Yes to continue entering your settings then continue to the next section Select No if you do not want to enter your Bolus Wizard settings message appears lett
29. Bolus deliveries Delivering a Preset Bolus Stopping a bolus delivery Contents vii E A gt ct D un MP6025957 024 A B Reservoir and infusion set 22 10 BH Meter 111 112 112 112 Setting up the reservoir and infusion set Disconnecting and reconnecting your infusion set About your compatible Bayer meter Wirelessly connecting your pump and meter Setting up Remote Bolus Deleting a meter from your pump B History and events 117 117 118 121 122 122 124 124 History Summary screen Understanding the Summary screen Daily History Alarm History Using Sensor Glucose Review ISIG History Event Markers BH Reminders 129 130 131 152 133 133 Personal reminders Bolus BG Check reminder Missed Meal Bolus reminder Low Reservoir reminder Set Change reminder Calibration reminders B General settings 137 138 139 viii Airplane Mode Audio Options Auto Suspend Contents MP6025957 024 A 139 140 141 141 142 145 146 148 Block Mode Carb Unit Display Options Language Managing your pump settings Self Test Sensor Demo Time and date B Setting up Continuous Glucose Monitoring 151 152 153 156 156 192 167 167 171 174 175 179 181 182 182 182 184 185 195 186 187 188 Understanding Continuous Glucose Monitoring CGM SmartGuard Home screen with CGM Understanding glucose settings High settings Low settings Turning on
30. Cleaning your pump on page 241 Infusion sets and sites For precautions related to the infusion sets and sites refer to the user guides provided with those devices Sensor For precautions related to the sensor refer to the user guide provided with that device Transmitter For precautions related to the transmitter refer to the user guide provided with that device Meter For precautions related to compatible Bayer meters refer to the user guide provided with that device Adverse reactions For adverse reactions related to the sensor refer to the user guide provided with that device Notice Radio Frequency RF communication This device complies with the United States Federal Communications Commission FCC and international standards for electromagnetic compatibility 10 Chapter 1 MP6025957 024 A This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the devices from unwanted electromagnetic interference This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to Part 15 of the FCC rules These limi
31. Hz Message tone 1655 Hz Reminder tone 934 Hz Fill tubing tone 1850 Hz Bolus delivery cancellation tone 1485 Hz followed by 1655 Hz and 1485 Hz Loading complete tone 934 Hz Reservoir loading in progress 1850 Hz tone Easy Bolus activation 1045 Hz Fasy Bolus step 1 increment 1175 Hz y Easy Bolus step 2 increment NT Easy Bolus step 3 increment 139 a Easy Bolus step 4 increment 1570 Hz Lo je Q c A et Uu Lo D A e N lo un tU Q N D et lt z o 3 0 5 Fasy Bolus step 5 increment 1760 Hz Backlight Type LED Light emitting Diode Time out 15 seconds default 30 seconds one minute three minutes Time out when battery is low 15 seconds default 30 seconds Basal delivery Delivery rate range O to 35 units per hour or the Max Basal Rate amount whichever is lower Max Basal Rate default 2 units per hour Product specifications and safety information 249 MP6025957 024 A Basal patterns Basal pattern names Increments BG Target Maximum targets Range Default value for High BG targets and Low BG targets BG meter value Maximum of 8 patterns Each pattern covers a 24 hour period and can have up to 48 rates Rates are set in 30 minute increments Fixed names Basal 1 Basal 2 Basal 3 Basal 4 Basal 5 Workday Day Off Sick Day e 0 025 units per hour for basal amounts in the range 0 to 0 975 units e 0 05 units per hour f
32. Limit Within Limits Below Low Limit Alert before high Alert on high Rise Alert Alert before low Alert on low 120 Chapter 7 Description Average sensor glucose value Standard deviation of the SG readings Percentage of SG readings that were above your high glucose alert limit If not set a high glucose alert limit your pump uses the default values For more details on setting your high glucose alert limit see High settings on page 156 Percentage of SG readings that were between your high and low glucose alert limits If you have not set your high and low glucose alert limits your pump uses the default values For more details on setting your high and low glucose alert limits see High settings on page 156 and Low settings on page 157 Percentage of SG readings that were below your low glucose alert limit If you have not set a low glucose alert limit your pump uses the default values For more details on setting your low glucose alert limit see Low settings on page 157 Number of Alert before high alerts that occurred Number of Alert on high alerts that occurred Number of Rise alerts that occurred Number of Alert before low alerts that occurred Number of Alert on low alerts that occurred MP6025957 024 A Summary screen SmartGuard The following table describes the SmartGuard portion of the Summary screen For details on the SmartGuard feature see SmartGuard on page 152 Name Des
33. U Remove reservoir and select Rewind to restart New Reservoir procedure No reservoir detected Rewind before loading reservoir Power error detected Delivery stopped Record your settings by uploading to CareLink or write your settings on paper See User Guide Power loss AA battery was removed for more than 10 min or power was lost Select OK to re enter time and date Explanation You have exceeded the number of units expected to fill the tubing By now insulin should be at the end of the tubing There is no reservoir in the pump or the reservoir is not properly locked into place The internal power source in your pump is unable to charge Your pump is operating on the AA battery only Your pump battery has been out for more than ten minutes and your pump has lost power You must reset your time and date Next steps e Remove the reservoir e Check if you still have insulin in the reservoir If you do you can continue using the same reservoir Select Rewind to restart the new reservoir procedure Select Rewind e Ensure that your reservoir is filled with insulin e When prompted ensure that your reservoir is inserted and properly locked into place Select OK to clear the alert e Check your BG and treat as necessary Record your settings as soon as possible because your AA battery may not last long e Call your local representative for
34. about 157 entering 171 examples 165 M maintenance 24 Manage Settings error alarm 210 managing pump settings 142 Manual bolus Dual Wave 82 Easy bolus 85 Normal bolus 75 Square Wave 79 Max Basal alarm 205 rate 40 Max Basal Rate setting 41 Max Bolus alarm 205 exceeded 73 setting 62 warning 63 Max Fill reached alarm 210 211 Menu screen about 32 accessing 32 audio options 33 display 21 event markers 33 history 33 insulin settings 33 reminders 33 reservoir and tubing 33 sensor settings 33 suspend delivery 33 utilities 33 messages about 199 audio options 202 blue icon 202 CGM 216 292 Index Connect Device 226 continuous glucose monitoring 216 overview 202 pump 202 226 Resume bolus 214 Resume Dual bolus 214 215 Resume Square bolus 215 sensor 216 Sensor connected 223 Missed Meal Bolus reminder 131 modes Block 139 power 34 mute alerts 193 N No calibration occurred alert 222 No reservoir detected alarm 211 Normal bolus about 73 Bolus Wizard 73 delivery 73 example 60 Manual bolus 75 resume message 214 notification light 201 notifications 31 O ordering supplies 15 p patterns basal about 42 adding 46 changing 46 copying 46 deleting 46 example 42 personal reminder 129 Possible signal interference alert 222 power save mode 34 MP6025957 024 A Preset Bolus about 86 changing 87 deleting 87 delivering 88 Dual Wave 86 renaming 87 setting up 86 Square Wave 86 Preset Tem
35. amount of insulin left in your reservoir The color and the fill level of the icon indicate the status When your reservoir is full the icon is solid green As your insulin is used the icon becomes emptier and the color of the icon changes as shown in the following example For more information about your reservoir see Reservoir and infusion set on page 93 The audio mode you using vibrate only audio y i fe only 4 or vibrate and audio q For more information about your audio settings see Audio Options on page 136 First steps 29 MP6025957 024 A Icon 30 Icon name Calibration Sensor Life Chapter 2 What it means The approximate time left until your next sensor calibration is due Appears only when the Sensor feature is turned on The color and the fill level of the icon indicate the status When your sensor is fully calibrated the icon is solid green As the time for your next sensor calibration approaches the icon becomes emptier and the color of the icon changes as shown in the following example For more information about calibrating your sensor see Calibrating your sensor on page 184 0006460 When your sensor is initializing the Calibration icon appears with three dots If the time to your next sensor calibration is unavailable the Calibration icon A appears with a question mark 2 The number of days remaining in the life of your
36. are available during the Square Wave bolus Turning on or off Square Wave bolus The Square Wave bolus delivery option is available only after you turn on the Square Wave feature To turn on or turn off the Square Wave feature 1 Go to the Dual Square screen Menu Insulin Settings Dual Square Wave 2 Select Square Wave to turn the feature on or off 3 Select Save Delivering a Square Wave bolus with the Bolus Wizard The Square Wave option is available in the Bolus Wizard only after you turn on the Square Wave feature Also you must have entered a Carbs value To deliver a Square Wave bolus with the Bolus Wizard 1 Go to the Bolus Wizard screen Home screen Bolus Bolus Wizard Bolus 77 MP6025957 024 A 8 The Bolus Wizard screen shows your current BG meter reading if applicable and any insulin that is still active from previous boluses For more information about active insulin see About active insulin on page 72 For more information see About your compatible Bayer meter on page 111 J Note Be aware that if you already have the Bolus Wizard open prior to wirelessly sending your BG meter reading to your pump you must close the Bolus Wizard and open it again in order for that reading to appear If you are not using a wirelessly connected compatible Bayer meter you can select BG to manually enter your BG meter reading Note If you choose not to enter a BG meter reading three dashes appear o
37. cannot find the sensor signal on page 234 e Calibrate again by the time shown on the pump screen to ensure you continue SG monitoring Select OK to clear the alert e Take another BG meter reading and calibrate again Move away from other electronic devices It can take up to 15 minutes for your pump to start communicating with your transmitter Select OK to clear the alert MP6025957 024 A Title and text Rise Alert Sensor glucose rising rapidly Sensor alert occurred Check Alarm History for silenced alerts Sensor connected If new sensor select Start New If not select Reconnect Sensor connected Start new sensor Explanation Your SG value has been rising as fast or faster than your preset Rise Alert Limit Sensor alert occurred when Alert Silence is on The transmitter has detected that you have connected a sensor The pump needs to know if this is a new sensor or if you have reconnected your old sensor The transmitter has detected that you have connected a sensor Next steps Select OK to clear the alert e Monitor trend and glucose level Follow instructions from your healthcare professional Select OK to clear the alert e Check the Alarm History screen to see which alerts were silenced For more information about accessing the Alarm History screen see Alarm History on page 122 e Select the alert to open the Alarm Detail scree
38. delivery Maximum infusion with a single fault condition is 0 2 units Pump dimensions The MMT 1511 pump dimensions in inches are approximately 2 1 width x 3 34 length x 0 96 depth The MMT 1511 pump dimensions in centimeters are approximately 5 3 width x 8 5 length x 2 44 depth The MMT 1711 pump dimensions in inches are approximately 2 1 width x 3 78 length x 0 96 depth The MMT 1711 pump dimensions in centimeters are approximately 5 3 width x 9 6 length x 2 44 depth Pump memory User settings and pump history are stored in non volatile memory which will retain data The memory size will hold 90 days of pump history before it becomes full and has to be written over This means that at any time the user can review a maximum of 90 days of history Pump weight The mass of the MiniMed 640G insulin pump MMT 1511 is approximately 91 9 grams The mass of the MiniMed 640G insulin pump MMT 1711 is approximately 95 7 grams Product specifications and safety information 259 Lo je Q c A et Uu Lo D A e A 0 Uu 0 Q N et lt 3 0 O MP6025957 024 A 260 Item High SG alert limit Alert before high Alert on high Time before high Rise Alert Rise Limit High Snooze Item Low SG alert limit Suspend before low Suspend on low Alert before low Alert on low Low Snooze Chapter 15 Sensor default settings High sensor se
39. enters sleep mode about two minutes after your pump enters power save mode if no buttons are pressed At this time your pump automatically locks If any button is pressed your pump returns to the Home screen Z Note In some cases if there is an action you need to take your pump returns to the screen last displayed This includes startup settings loading your reservoir filling your tubing filling your cannula and any screen where you have an action pending To put your pump into sleep mode press and hold the Menu button for about two seconds If you remove your pump You may have an occasion when you need or want to remove your pump If you have to remove and store your pump it is recommended that you do the following Write down a record of your current basal rates and use the Save Settings feature See Saving your settings on page 142 for more information e Remove the battery See Storing your pump on page 242 for more information Remember your body still needs insulin while your pump is removed Consult your healthcare professional to determine an alternate method of receiving insulin Disconnecting from your pump for less than one hour may not require an insulin adjustment If you remove your pump for more than one hour you should take your insulin another way as prescribed by your healthcare professional First steps S MP6025957 024 A 36 Chapter 2 eseq MP6025957 024 A MP6025957 024
40. exercise Glossary 279 ED c u un 0 lt MP6025957 024 A exchange ratio food bolus High limit infusion set infusion site insulin sensitivity factor interstitial fluid ISIG lock Low limit Manual Bolus Max Basal Rate Max Bolus meter 280 Glossary The number of insulin units that are needed to cover 1 carbohydrate exchange The exchange ratio is based on your individual needs and is used to calculate bolus amounts A dose of insulin you give to cover an expected rise in glucose levels from carbohydrates The value you set to determine when the pump will alert you of a high sensor glucose condition Tubing that connects to the reservoir on one end and has a needle or cannula on the other end that you insert into your body Insulin travels from the pump through the infusion set into your body The location on the body where the infusion set is inserted The amount that blood glucose is reduced by one unit of insulin The insulin sensitivity factor is used to calculate correction bolus amounts The fluid that surrounds the cells in the body The signal created by the sensor that is used to calculate your sensor glucose value Typically used by Medtronic technical support representatives when troubleshooting A pump feature that prevents accidental button presses The value you set to determine when the pump will alert of a low sensor glucose condition and also use
41. fill the cannula Select Done when the system prompts you to continue with the fill process To fill the cannula 106 After you fill your tubing and insert your infusion set the Fill Cannula screen appears Fill Cannula 1 Insert infusion set into body 2 Select Fill to fill cannula or Done if not needed Note If your screen turns off before you are ready to fill your A cannula press any button on your pump to turn it on again To fill your cannula now select Fill If you are using an infusion set with a needle you do not need to fill the cannula Select Done to skip this step The Fill Cannula screen appears Fill Cannula 1 Verify Fill amount 2 Select Fill Now when ready Select Back to cancel Fill Now Adjust the Fill amount for your particular infusion set and then select Fill Now If you are unsure about the fill amount see the instructions that came with your infusion set As the cannula starts filling your screen displays the amount of units being delivered The pump beeps or vibrates when the delivery is complete Chapter 5 MP6025957 024 A After the cannula is filled the Home screen appears Your pump is now ready to deliver insulin To stop filling the cannula 1 Select Stop Filling to stop filling the cannula Fill Cannula Total 0 300 2 Select Yes The Fill Stopped screen appears confirming amount delivered 3 Select Done D un M 4 lt
42. for Max Fill Reached Select Next to continue Follow the instructions in the next section to insert the infusion set into your body before filling the cannula Chapter 5 MP6025957 024 A Inserting the infusion set WARNING Do not remove the reservoir from the pump while the infusion set is connected to your body This could lead to over or under delivery of insulin You must have completed the following procedures as described previously before inserting the infusion set into your body Rewinding your pump Filling your reservoir Inserting the reservoir into pump Filling the tubing with insulin Shown here are the best body areas shaded for infusion set insertion Avoid the 5 0 cm 2 inch area around the navel to help ensure a comfortable infusion site 3 D un M _ 5 lt ar 5 5 E m 5 N M et and to help with adhesion AN Caution Rotate the infusi insertion sites so that they do not become overused QU x A Caution Change your infusion set every two to three days to avoid infusion set occlusion or site infection Reservoir and infusion set 103 MP6025957 024 A To keep sites healthy some people find it helpful to use a visual scheme to help them rotate their insertion sites in an organized way For example here are two commonly used methods For maximum effectiveness use both methods alternating between them Visualize an imaginary clock drawn on your
43. helpline 852 2919 6441 India India Medtronic Pvt Ltd Tel 4 91 80 22112245 32972359 Mobile 91 9611633007 Indonesia Medtronic International Ltd Tel 65 6436 5090 or 65 6436 5000 Israel Agentek Tel 972 3649 3111 Italia Medtronic Italia SpA Tel 39 02 24137 261 Fax 39 02 24138 210 Servizio assistenza tecnica verde 24h 800 20 90 20 Japan Medtronic Japan Co Ltd Tel 81 3 6430 2019 24 Hr Support Line 0120 56 32 56 Kazakhstan Medtronic BV in Kazakhstan Tel 7 727 311 05 80 Almaty Tel 7 717 224 48 11 Astana Latin America Medtronic Inc Tel 1 305 500 9328 Fax 1 786 709 4244 Latvija Ravemma Ltd Tel 371 7273780 Macedonia Alkaloid Kons Dooel Tel 389 2 3204 430 Magyarorsz g Medtronic Hung ria Kft Tel 36 1 889 0688 Malaysia Medtronic International Ltd Tel 603 7946 9000 Middle East and North Africa Regional Office Tel 961 1 370 670 Montenegro Glosarij Tel 382 20 642 495 Fax 382 20 642 540 M xico Medtronic Servicios S de R L de CV Tel M xico DF 11 029 058 Tel Interior 01 800 000 7867 Medtronic Directo 24 7 from M xico DF 55 36 869 787 Medtronic Directo 24 7 01 800 681 1845 Nederland Luxembourg Medtronic BV Tel 31 0 45 566 8291 Gratis 0800 3422338 New Zealand Medica Pacifica Phone 64 9 414 0318 Free Phone 0800 106 100 MP6025957 024 A Norge Medtronic Norge A S Tel 47 67 10 32 00 F
44. is present in the interstitial fluid and is measured by a glucose sensor A reminder that you can set to change your infusion set Abbreviation for sensor glucose See sensor glucose A state in which your pump is fully functional but the screen is dark Your pump automatically enters sleep mode when you have not pressed any buttons for about two minutes A feature that can automatically stop and resume insulin delivery based on your sensor glucose values and low limit A bolus delivered evenly over a specified time period A feature that suspends insulin delivery when the sensor predicts sensor glucose value is approaching your low limit This feature stops all insulin delivery until you resume it Only the basal insulin restarts when delivery is resumed A feature that suspends insulin delivery when your sensor glucose value reaches or falls below your low limit A feature that allows you to temporarily increase or decrease your current basal rate for a duration of time that you specify The plastic piece that comes attached to the reservoir It is used to connect the reservoir to the insulin vial while filling the reservoir with insulin MP6025957 024 A transmitter A device that connects to a glucose sensor The transmitter collects data measured by the sensor and wirelessly sends this data to monitoring devices 5016 Glossary 283 MP6025957 024 A 284 Glossary MP6025957 024 A Xapul M
45. line s to powered device earth Voltage dips short lt 5 Uy Not applicable Requirement does not interruptions and gt 95 dip in apply to this battery voltage variations on powered device for 0 5 cycle power supply lines IEC 61000 4 1 1 Power frequency 400 A m 400 A m Power frequency 50 60 Hz magnetic continuous magnetic fields should field field at 60 be at levels IEC 61000 4 8 seconds characteristic of a typical location in a 4000 A m short 4000 A m duration at 3 typical commercial or hospital environment seconds Note Uy is the a c mains voltage prior to application of the test level Product specifications and safety information 263 Lo je Q c A et N Lo D A e N 0 un 0 Q N et lt O 3 0 le MP6025957 024 A Guidance and Manufacturer s Declaration Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment Immunity IEC 60601 Compliance Electromagnetic Environment Test Level Level Guidance Portable and mobile RF communications equipment should be used no closer to any part of the MiniMed insulin pump including cables than the recommended separation distance calculated from the equation applicable to
46. not detect a problem the display returns to the Utilities screen If Self Test detects a problem a message appears with more information about the problem If Self Test displays an error message or you observe the pump not behaving as indicated during the test contact the 24 Hour HelpLine or your local representative Sensor Demo Sensor Demo lets you see what the Home screen would look like if you were using the optional Continuous Glucose Monitoring CGM feature For more information about sensor graphs please see The sensor graph on page 191 146 Chapter 9 MP6025957 024 A WARNING Do not use Sensor Demo to make any decisions related to your therapy Information seen in the Sensor Demo is not real data It is an example of the type of information you can access when using the sensor feature Making treatment decisions based on data that is not real can lead to low or high blood glucose conditions To view the sensor graphs li 4 Go to the Sensor Demo screen Menu Utilities Sensor Demo A screen appears as an example of what your Home screen looks like when you are using the optional CGM feature Sensor Sensor Demo ni u Act Ins 0 30 Alert Demo Press Select to access the sensor graph examples From the sensor screen examples you can e Press the lt or gt buttons to move the cursor across the graph Examples of sensor data appear for the different time periods Pr
47. o 5 h v o N M et Disconnecting and reconnecting your infusion set As an example these steps show you how to disconnect and reconnect the Quick set infusion set If you are using an infusion set other than Quick set always refer to the instructions that shipped with the infusion set Disconnecting the Quick set infusion set The Quick set infusion set allows you the freedom to temporarily disconnect from your pump without removing the infusion set from your body 1 Hold the side grips of the connector part with your fingers 2 Twist the connector counter clockwise 3 Remove the connector from the site Reservoir and infusion set 107 MP6025957 024 A Reconnecting the Quick set infusion set Place the connector part flat side facing down on the infusion site until it is fully seated Do not squeeze the connector part by the flat side grips 108 Chapter 5 1A9 9UU MP6025957 024 A MP6025957 024 A Meter You can wirelessly connect up to six compatible Bayer meters to your pump If you do not connect a meter to your pump you must enter your blood glucose readings manually To wirelessly connect your pump and meter you will need the following items MiniMed 640G insulin pump Compatible Bayer meter Compatible Bayer meter user guide About your compatible Bayer meter You can set up your pump to automatically receive blood glucose readings from your compatible Bay
48. obtained using a home blood glucose monitor and not based on the value displayed by the pump Before you begin 5 cb 1 M lt O Q MP6025957 024 A Contraindications Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms General warnings Pump The pump is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Never rely on the pump beeps or vibrations alone to navigate through the pump screens or menus because this may result in incorrect menu selection or setting Do not rely on preset pump alarms or reminders alone to prompt you to check your blood glucose Set additional reminders on other devices such as your cell phone to avoid forgetting to check your blood glucose Standard Luer sets are not compatible with the MiniMed 640G insulin pump MiniMed reservoirs and MiniMed compatible infusion sets are specifically designed for use with the MiniMed 6406 insulin pump Do not modify your MiniMed reservoir or MiniMed compatible infusion set Only use U100 insulin that has been prescribed by your healthcare professional
49. range up to 1 8 meters 6 feet Maximum output 1 59 dBm power EIRP Operating frequencies 2420 MHz 2435 MHz 2450 MHz 2465 MHz 2480 MHz Bandwidth 5 MHz which is allocated channel bandwidth per the IEEE protocol Data security The MiniMed 640G insulin pump is designed to only accept radio frequency RF communications from recognized and linked devices you must program your pump to accept information from a specific device The MiniMed 640G system ensures data security via proprietary means and ensures data integrity using error checking processes such as cyclic redundancy checks Product specifications and safety information 269 Lo 5 je Q c A et Uu Lo A e A 0 Uu 0 Q N et lt 3 0 le MP6025957 024 A Icon table CN GN Emme NN ee Sd Catalogue number Storage temperature range Storage humidity range Magnetic Resonance MR unsafe Type BF equipment protection from electrical shock Radio communication Pump Protected against the effects of continuous immersion in water 12 feet or 3 6 meters for 24 hours Signifies compliance with Australian EMC EME and Radio communications requirements Signifies compliance with Industry Canada EMC and Radio communications requirements This symbol means that the device fully complies with MDD 93 42 EEC NB 0459 and R amp TTE Directive 1999 5 EC 2 0 Chapter 15
50. reevaluate your need for insulin e If this alarm recurs frequently write down the error code displayed on the alarm screen you can also find it in your Alarm History and contact your local representative for assistance with your pump MP6025957 024 A Title and text Pump error Delivery stopped Settings unchanged Select OK to continue See User Guide Pump restarted Delivery stopped Settings unchanged Select OK to continue See User Guide Replace battery Battery life less than 30 minutes To ensure insulin delivery replace battery now Explanation Your pump encountered an error but a restart is not necessary The issue is resolved Your settings are not changed Your pump has encountered a problem and has restarted Your settings have not been changed Battery life is low and will be exhausted within 30 minutes Next steps Select OK to resume basal delivery e If the pump was delivering a bolus or filling the cannula check Daily History and reevaluate your need for insulin e If this alarm recurs frequently write down the error code displayed on the alarm screen you can also find it in your Alarm History and contact your local representative for assistance with your pump Select OK to continue e If the pump was delivering bolus or filling the cannula check Daily History and re evaluate your need for insulin e If this alarm recurs frequently
51. remaining amount of bolus select Resume Select OK to clear the alarm e If this alarm occurs again contact your local representative for assistance with your pump If you are unable to clear the alarm Consider another form of insulin because your pump is not delivering insulin e Check your BG and treat as necessary e Contact your local representative for assistance with your pump Alarms alerts and messages 215 EY s 2 D et di gt 3 M N M un MP6025957 024 A Title and text Explanation Next steps Wrong key pressed Wrong button e Select OK to clear the alert Try again selected while Try to unlock the pump Select unlocking the the highlighted key when purnp prompted For more information see Unlocking your pump on page 26 CGM sensor alarms alerts and messages The following table lists the most common or serious alarms alerts and messages related to your sensor glucose readings as well as the status of your transmitter and sensor The table also explains the meaning consequences and the reasons why these notifications appear and provides steps for problem resolution Title and text Explanation Next steps Alert before high Your SG value is Select OK to clear the alert Sensor glucose approaching your Check your BG approaching High Limit PATE Followinstiuctions nom your Check BG healthcare professional and continue to
52. residue from the battery compartment opening Maintenance 241 MP6025957 024 A Cleaning your transmitter Always refer to your transmitter user guide for instructions on cleaning the transmitter Storing your pump Storage mode allows you to safely place your pump in storage while not in use Note If you place your pump in storage mode it is important to insert a new AA battery for 8 to 12 hours every six months to recharge the internal power source WARNING Active insulin is now cleared Any active insulin tracked prior to the pump entering storage mode is not included in any new Bolus Wizard calculations Placing your pump in storage mode 1 Remove the AA battery from the pump For details see Removing the battery on page 23 Note When you remove the battery your pump issues an Insert Battery alarm for 10 minutes or until you place your pump into storage mode 2 Press and hold amp until your screen turns off AN Caution Store your pump at room temperature While in storage the pump should never be exposed to temperatures above 35 C 95 F Waking your pump from storage mode 1 Insert a new AA battery into your pump For details see Inserting the battery on page 22 242 Chapter 14 MP6025957 024 A A Pump Error message appears 2 Select OK Your pump displays a Power Loss alarm 3 Select OK The Time amp Date screen appears 4 Enter the current Time Time Format and Date 5 Selec
53. screen Menu Sensor Settings Sensor Connections Select Start New Sensor The Start New Sensor screen appears If you have not done so already connect the transmitter to your sensor For details about connecting your transmitter and sensor see your transmitter user guide Your pump searches for your transmitter signal It can take up to six minutes for your pump and transmitter to start communicating Select OK The Sensor warm up started message appears on the screen Select OK Warm up appears on the Home screen until the sensor is ready for first calibration Your pump begins displaying SG data up to 15 minutes after you successfully calibrate your sensor For details about calibration see Calibrating your sensor on page 184 If you receive a message that your pump cannot find the sensor signal continue to the next section If your pump cannot find the sensor signal 1 If your pump cannot find the sensor signal follow the instructions on your pump screen Your pump guides you through the following steps a Disconnect and reconnect the transmitter from the sensor Pay attention to the transmitter and notice if the transmitter light blinks when connected to the sensor If the transmitter light does not blink you need to charge your transmitter 0 Move your pump closer to your transmitter It can take up to 15 minutes for your pump to find the sensor signal C If your pump is still unable to find the se
54. status of your system The status bar contains the icons that are described in the following table along with the current time For information on viewing detailed status screens see Status screens on page 31 Icon 28 Icon name What it means Battery The charge level of your pump battery The color and the fill level of the icon indicate the status When your battery is full the icon is solid green As your battery life is used the icon changes as shown in the following example For more details about batteries see About batteries on page 21 22233 Chapter 2 MP6025957 024 A Icon Icon name Y Connection 3 Airplane Mode F Reservoir lt Audio What it means The connection icon appears green T when the Sensor feature is on and your transmitter is successfully communicating with your pump The connection icon appears gray SA when the Sensor feature is turned on but the transmitter is not connected or communication with your pump has been lost For more information about the Sensor feature see Understanding Continuous Glucose Monitoring CGM on page 151 Appears in place of the Connection icon if Airplane Mode is turned on When Airplane Mode is turned on the pump cannot receive wireless communication from other devices The pump also cannot send wireless communication to other devices For more information about using Airplane Mode see Airplane Mode on page 137 Shows the approximate
55. steps or your max bolus limit whichever comes first To help you count your Easy Bolus steps each time you press the A button your pump makes a different tone There are five different tones that repeat if you use more than five steps Understanding Easy Bolus step sizes When setting up Easy Bolus you set the step size from 0 1 to 2 0 units Your step size cannot be higher than your max bolus Set the step size to a number that is convenient to use and easy to multiply The following example shows how your bolus amount is increased with each step or each press of the A button when using the Easy Bolus feature to deliver a bolus In this example the step size is 0 5 units For a delivery of 2 0 units you would need four steps or press the A button four times when using the Easy Bolus feature Bolus 83 MP6025957 024 A Total number steps 4 Total number button presses 4 4 steps 2 0 units 2 steps 1 0 units 1 step 0 5 units 1 5 Total number units Setting up Easy Bolus The Easy Bolus option is available only after you turn on the feature To set up Easy Bolus 1 Go to the Easy Bolus screen A Menu Insulin Settings Easy Bolus 2 Select Easy Bolus to turn on the feature 3 Set the Step Size amount in units You can set the step size from 0 1 to 2 0 units Your step size cannot be higher than your max bolus 4 Select Save Delivering a bolus u
56. the frequency of the transmitter 264 Chapter 15 MP6025957 024 A Guidance and Manufacturer s Declaration Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment Radiated RF 10 V m 10 V m Recommended separation distance IEC 61000 4 3 80 MHz to 80 MFZ to d 12 E JP 80 MHz to 800 MHz 800 MHz 10 V m 10 V m 23 E VP 800 MHz to 6 GHz 800 MHz to 800 MHz to 6 25 GHz SIME Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in 5 O c A et Uu i A e 25 A 0 O un 0 Uu 2 et lt 5 O 3 0 et O 5 each frequency range Interference may occur in the vicinity of equipment marked with the following symbol te Note At 80 MHz and 800 MHz the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Note The table is per IEC EN 60601 1 2 Edition 3
57. the Sensor feature Setting up the High Settings Setting up the kow Settings Manually resuming basal delivery during a suspend by sensor event Wirelessly connecting your pump and transmitter using Auto Connect Wirelessly connecting your pump and transmitter using Manual Connect Deleting the transmitter from your pump Inserting the sensor Connecting the transmitter to the sensor Starting the sensor Calibrating your sensor Setting up Auto Calibration Where to enter your calibration BG meter reading When to calibrate Guidelines for calibrating Disconnecting the transmitter from the sensor Contents ix E A gt ct D un MP6025957 024 A 188 188 Removing the sensor Turning off Sensor Settings B Using continuous glucose monitoring 191 192 193 The sensor graph Identifying rapid changes in sensor glucose Silencing Glucose Alerts B Alarms alerts and messages 199 200 201 202 202 216 226 About alarms alerts and messages Alarms Alerts Messages Pump alarms alerts and messages CGM sensor alarms alerts and messages CareLink alert and message m Troubleshooting 229 230 230 230 231 231 231 232 234 234 230 236 Troubleshooting pump issues What is a Check Settings alarm My pump is asking me to rewind dropped my pump cannot get to the Manage Settings screen My pump display times out too quickly Where is my pump status screen My pump is asking m
58. the next section to fill the tubing with insulin Filling the tubing You need to fill the infusion set tubing with insulin before you insert the set into the body Reservoir and infusion set 101 MP6025957 024 A WARNING Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing Never insert the reservoir into the pump while the tubing is connected to your body Doing so could result in an accidental infusion of insulin which may cause low BG WARNING Always check your tubing for air bubbles Continue to press Fill until the bubbles have been removed from the tubing Air bubbles may result in inaccurate insulin delivery To fill the tubing ls 102 After you load your reservoir and select Next from the Load Reservoir screen the Fill Tubing screen appears Fill Tubing DO NOT CONNECT TO BODY Hold Fill until drops appear Then select Next 0 0u Next Select and hold Fill Your pump beeps six times to let you know it is positioning the reservoir Continue holding Fill until insulin droplets form on the tip of the infusion set needle then release Your pump beeps as it fills the tubing and the amount of insulin you are using appears on the screen If you get the Max Fill Reached alarm it means you have used more than 30 units of insulin to fill your tubing For details go to Pump alarms alerts and messages on page 202 and see the description
59. to restart See User Guide Max Fill reached 3X X U Did you see drops at the end of tubing 210 Chapter 12 Explanation Your reservoir is low on insulin according to the number of hours or units set in the Low Reservoir Reminder A pump error has occurred and you need to restart your pump Your backup settings have been lost but your current settings are unchanged You have exceeded the number of units expected to fill the tubing By now insulin should be at the end of the tubing Next steps e Select OK to clear the alert e Change the reservoir soon If you do not change the reservoir after you receive this alert you will receive a second Low reservoir alert when the insulin level reaches half of your original alert amount For more details see Low Reservoir reminder on page 132 e Select OK to restart your pump Your current settings are unchanged Only your backup settings are lost When the pump restarts follow instructions on the pump display e If the pump was delivering bolus or filling the cannula check Daily History and evaluate your need for insulin e Consider saving your current settings For details see Saving your settings on page 142 If you see drops at the end of the tubing select Yes If you do not see drops select No Follow instructions displayed on the pump MP6025957 024 A Title and text Max Fill reached AX X
60. to deliver a bolus For details on using the Bolus Wizard see Bolus Wizard on page 65 For details on entering events see Fvent Markers on page 124 Active Displays the amount of bolus insulin the pump estimates is still working Insulin to lower your blood glucose levels For more details on active insulin see About active insulin on page 72 First steps 27 MP6025957 024 A Item Bolus Basal Description Allows you to access your bolus delivery options and provides access to all of your insulin settings For details about entering your bolus settings and delivering bolus insulin see the Bolus chapter on page 59 If you have not set up the Bolus Wizard and Preset Bolus features you only have access to Manual Bolus from this screen For details about setting up the Bolus Wizard feature see Bolus Wizard on page 65 For details about setting up the Preset Bolus feature see Preset Bolus on page 86 Allows you to access your basal delivery options and provides access to all of your insulin settings For details about entering your basal settings and delivering basal insulin see the Basal chapter on page 39 To access all of your basal options from this screen you must have set up a Preset Temp basal rate For details about setting up Preset Temp basal rates see Preset Temp basal rates on page 49 Status bar The status bar appears at the top of the Home screen to provide a way for you to quickly check the
61. 025957 024 A Title and text Insulin flow blocked Check BG Consider injection and testing ketones Change reservoir and infusion set 206 Chapter 12 Explanation Your pump has detected that the basal or bolus insulin flow was blocked Next steps e Check your blood glucose Consider checking ketones and take an injection if needed e Remove your infusion set and reservoir Select Rewind to start the new reservoir process using a new infusion set and reservoir If a bolus delivery was in progress when the alarm occurred e Check the Daily History screen for the amount of bolus already delivered before the pump alarmed e Consider delivering remaining bolus if the bolus insulin was not included in an insulin injection MP6025957 024 A Title and text Explanation Next steps Insulin flow blocked Your pump has e Check your blood glucose Chede PC Ferdi detected that the Consider checking ketones and injection and testing insulin flow was take an injection if needed ketones Estimated 0 U blocked and there iS Remove your infusion set and insulin in reservoir no insulin in the reservoir reservoir Change reservoir and e Select Rewind to start the new infusion set reservoir process using a new infusion set and reservoir If a bolus delivery was in progress when the alarm occurred e Check the Daily History screen for the amount of bolus already delivered before the pump alarmed
62. 209 Low battery transmitter 221 Low reservoir 210 No calibration occurred 222 notification light 201 overview 201 Possible signal interference 222 pump 202 226 Reservoir estimate 214 Rise alert 223 sensor 216 Sensor alert occurred 223 Sensor expired 224 Sensor signal not found 224 SG value not available 225 silencing 193 Transmitter battery depleted 225 yellow icon 201 areas for inserting infusionsset 103 arrows trend 192 audio options 33 settings 138 silencing 193 vibrate 29 auto connect 1 5 Auto Suspend alarm 203 awake mode 34 B backlight battery use 21 setting up 141 basal about 39 current delivery 52 288 Index daily delivery amount 118 delivery 39 history 117 118 Home screen 26 Max Basal Rate 41 patterns 41 Preset Temp basal rate 49 rate 39 settings 40 summary 117 Temp Basal 47 basal patterns about 42 adding 46 changing 46 deleting 46 example 42 battery about 21 alarm 203 205 213 214 alert 209 belt clip 23 compartment location 19 disposal 23 inserting 22 removing 23 replacing 22 status bar icon 28 types 21 Battery failed alarm 203 Battery not compatible alarm 203 belt clip part number 15 remove battery cap 23 BG Home Screen 26 sensor calibration 185 BG meter readings average 119 manual high 120 manual low 120 meter high 120 meter low 119 summary 119 MP6025957 024 A BG not received alert 218 BG target Bolus Wizard 66 setting up 70 Block Mode status bar 31 using 139
63. 3 0 et O Allows user to set up and deliver a Normal Bolus when the pump is in Sleep Mode This is done using the A and with the help of audio and vibration cues Audio mode range to 20 increments or Max Bolus limit whichever comes first Vibrate mode range to 20 increments or Max Bolus limit whichever comes first Default step size 0 1 unit Adjustable step size 0 1 to 2 units per increment up to Max Bolus limit Environmental conditions e Pump operating temperature range is from 5 C 41 F to 40 C 104 F e Air pressure range is from 10 2 psi to 15 4 psi 700 hPa to 1060 hPa Product specifications and safety information 235 MP6025957 024 A Operating humidity range of the case 2096 to 9096 This requirement exceeds IEC 60601 1 subclause 7 9 3 1 30 to 75 Filling the infusion set and cannula The cannula can be filled from 0 025 units to 5 1 units in increments of 0 025 units The standard fill rate is 1 5 units per minute The quick fill rate is 15 units per minute When filling the tubing a warning occurs at 30 units and thereafter at every 10 units Insulin used to fill the infusion set is recorded in the Daily History Infusion pressure The maximum infusion pressure and occlusion pressure is 86 12 kPa 12 49 psi Insulin delivery default settings Bolus settings Item Bolus Wizard feature Easy bolus Easy bolus step size Bolus increment Dual Square bolu
64. Chapter 5 MP6025957 024 A New Reservoir 1 Fill reservoir 2 Connect tubing to reservoir DO NOT CONNECT TO BODY The New Reservoir screen now instructs you to place the reservoir in your pump New Reservoir 3 Place reservoir into pump and lock DO NOT CONNECT TO BODY Note If the New Reserveir screen has timed out and the Home A Screen appears select Load Reservoir from the Home screen 15 Follow the instructions im the next section to insert the reservoir into the reservoir compartment of your pump immediately after filling it Inserting the reservoir into your pump Be sure to perform the following steps in the order they are presented AN Caution Do not insert the reservoir into your pump for the first time until you have received training Reservoir and infusion set 99 D un M _ 5 lt o 5 5 h 5 N M et MP6025957 024 A WARNING Never insert the reservoir into the pump while the tubing is connected to your body Doing so could result in an accidental infusion of insulin which may cause low BG You must rewind your pump before installing a new reservoir to ensure correct insulin amount To insert the reservoir into your pump la 100 If you are using the pump for the first time remove the shipping cap from the reservoir compartment Rewind your pump if you have not yet done so See Rewinding your pump on page 94 for more info
65. D A e N Uu tU Q N D et lt o 3 0 o MP6025957 024 A Minutes from Audio Audio and vibration Vibration alarm or alert 0 1 Audio Audio Audio Audio Audio Audio Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Siren and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Siren and vibrate Vibrate Vibrate Vibrate Vibrate Vibrate Vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Siren and vibrate Z Note The Medical device alarm sirens immediately Altitude range Pump operating range is from 70 33 kPa 10 2 psiA to 106 18 kPa 15 4 psiA Storage range is from 49 64 kPa 7 2 psiA to 106 18 kPa 15 4 psiA Audio frequency The following table lists the various audible tones and their corresponding frequencies Tone name Alarm Alternate Alarm Siren escalated alarm Alert 248 Frequency tolerance 1 1655 Hz followed by 3310 Hz 1850 Hz 1655 Hz followed by 3310 Hz 934 Hz Chapter 15 MP6025957 024 A Tone name Frequency tolerance 1 High Sensor Glucose 1312 Hz followed by 1410 Hz 1500 Hz 1619 Hz 1722 Hz Low 5G 1722 Hz 1619 Hz 1500 Hz 1410 Hz 1312 Hz Lost SG 1485 Hz followed by 1395 Hz 1320 Hz 1395
66. MP6025957 024 A MiniMed 640G System User Guide MP6025957 024 A MP6025957 024 A MiniMed 640G System User Guide MP6025957 024 A Copyright amp trademarks 02015 Medtronic MiniMed Inc All rights reserved CareLink Guardian Bolus Wizard Enlite MiniLink Dual Wave Square Wave MiniMed and SmartGuard are trademarks of Medtronic MiniMed Inc Bayer is a trademark of Bayer Humalog is a trademark of Eli Lilly and Company NovoLog and NovoRapid are trademarks of Novo Nordisk A S SN Medtronic e Medtronic MiniMed 18000 Devonshire Street Northridge CA 91325 USA 800 646 4633 818 576 5555 C Een Ro 0459 Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands REF MMT 1511 MMT 1711 6025957 024_a MP6025957 024 A Contacts Africa Medtronic Africa Pty Ltd Tel 27 0 11 677 4800 Argentina Corpomedica SA Tel 11 4814 1333 Medtronic Directo 24 7 0800 333 0752 Australia Medtronic Australasia Pty Ltd Tel 1800 668 670 product orders Tel 1800 777 808 customer help Azerbaijan Isomed Tel 994 12 464 11 30 Bangladesh Sonargaon Healthcare Pvt Ltd Mobile 4 91 9903995417 or 880 1714217131 Belarus Badgin Ltd Tel 375 17 313 0990 Belgi Belgique NV Medtronic Belgium SA Tel 0800 90805 Bosnia and Herzegovina Medimpex doo Tel 4 387 33 476 444 or 4 387 33 476 400 Fax 387 33 476 401 or 387 33 432 24
67. Mode is turned on the Remote Bolus feature is not available and you must enter BG meter readings manually When Airplane Mode is turned off use your compatible Bayer meter normally Use your non linked BG meter normally whether Airplane Mode is on or off General settings 137 Q D 5 2 N M et a Q N MP6025957 024 A When using Do this this device Sensor and When Airplane Mode is turned on your pump does not receive transmitter sensor readings from your transmitter Your transmitter continues to collect your sensor readings and can store up to 10 hours of sensor data When Airplane Mode is turned off it can take up to 15 minutes before the pump and the transmitter start to wirelessly communicate again The transmitter begins to send the last 10 hours of your sensor information to the pump When you turn off Airplane Mode e If Airplane Mode was turned on for six hours or less wait 15 minutes for the sensor and transmitter to wirelessly send your pump the missing sensor glucose readings e If Airplane Mode was turned on for more than six hours disconnect and reconnect the transmitter and sensor and then select Reconnect Sensor when it appears on the pump screen To turn on or turn off Airplane Mode 1 Go to the Airplane Mode screen Menu Utilities Airplane Mode 2 Select Airplane Mode to turn the feature on or off 3 Select Save When Airplane Mode is turned on the status bar show
68. Now portion delivery and how to stop a Square Wave bolus or a Dual Wave bolus during the Square portion delivery 88 Chapter 4 MP6025957 024 A Note This procedure describes how to stop a bolus that is in progress It does not stop your basal insulin delivery If you need to stop all insulin delivery use the Suspend Delivery feature Menu Suspend Delivery To stop a Normal bolus delivery or the Now portion of a Dual Wave bolus delivery 1 While your pump is delivering your Normal bolus or the Now portion of a Dual Wave bolus select Stop Bolus from the Home screen 2 To stop your bolus select Yes to confirm Note If you are delivering a Normal bolus and a Square Wave bolus at the same time or a Normal bolus and the Square portion of Dual Wave bolus at the same time both boluses are stopped The Bolus Stopped screen appears and shows the amount of bolus delivered and the original bolus amount you set up To stop a Square Wave bolus delivery or the Square portion of a Dual Wave bolus delivery 1 Select Bolus S or Bolus D from the Home screen 2 Select Stop Bolus 3 To stop your bolus select Yes to confirm Note If you are delivering a Normal bolus and a Square Wave bolus at the same time or a Normal bolus and the Square portion of a Dual Wave bolus at the same time both boluses are stopped Bolus 89 MP6025957 024 A The Bolus Stopped screen appears and shows the amount of bolus del
69. OK again to confirm your settings When you have set all the high settings for the selected time segment select Next to continue IF you entered an End time of anything other than 00 00 another time segment appears When you are finished entering high settings select Done Review your settings and select Save To change your High Settings Em Wy d we 1 170 Go to the High Settings screen Menu Sensor Settings High Settings The High Settings screen appears Select Setup Select Edit Select and if needed adjust the time segment you would like to change Select any alert setting to turn it on or off or to adjust the setting Select Next Select Done Chapter 10 MP6025957 024 A 8 Review your settings and select Save High Snooze High Snooze is available once you have set your High Settings High Snooze allows you to set the amount of time that you want to wait before you are reminded that an alert condition still exists After a high alert is received and cleared you will be alerted again only if the high alert condition still exists after the snooze time you have set Setting the High Snooze 1 Go to the High Settings screen Menu Sensor Settings High Settings The High Settings screen appears 2 Select Snooze and enter a value from 5 minutes to 3 hours in 5 minute increments Setting up the Low Settings The steps below guide you through setting up the Low Settin
70. P6025957 024 A MP6025957 024 A Index A accessories 15 active insulin about 72 adjustment 72 Clearing settings 144 Home screen 26 injection warning 72 viewing amount 27 Active Insulin cleared alert 203 Active Insulin Time about 66 changing 71 Airplane Mode setting up 138 status bar 29 using 137 Alarm History 122 alarms about 199 audio options 201 Auto Suspend 203 Battery failed 203 Battery not compatible 203 Bolus not delivered 204 Bolus stopped 204 CGM 216 Critical pump error 205 Delivery limit exceeded 205 emergency siren 201 Fill Cannula 205 Insert battery 205 Insulin flow blocked 206 207 208 209 Loading incomplete 209 Manage Settings error 210 Max Fill reached 210 211 No reservoir detected 211 notification light 201 overview 200 pump 202 226 Bump error 212 213 Pump restarted 213 red icon 201 Replace battery 213 Replace battery now 214 sensor 216 siren 201 Stuck button 215 Alert before high SG setting 157 Alert before low about 161 summary screen 120 Alert on high SG setting 157 Alert on low about 164 summary screen 120 Alert Silence 193 alerts about 199 Active Insulin cleared 203 audio options 201 BG not received 218 Calibrate now 219 Calibration not accepted 219 Cannot connect device 204 Index 287 MP6025957 024 A Cannot find sensor signal 220 CGM 216 Change sensor 220 Check connection 221 Check settings 204 Download slow 226 Lost sensor signal 221 Low battery Pump
71. Select the desired Preset Bolus 3 Select Options 4 Do one of the following Bolus 87 MP6025957 024 A Select Edit to adjust the Bolus value and Type if applicable If you change to a Square Wave bolus you need to enter the Duration If you change to a Dual Wave bolus you need to enter the Now and Square amounts and the Duration Select Rename to assign a different name to this Preset Bolus When the Select Name screen appears you can select any available name from the list Select Delete to delete this Preset Bolus Delivering a Preset Bolus Follow these steps to deliver a Preset Bolus You must set up Preset Bolus deliveries before you can use the Preset Bolus feature For more information see Setting up and managing Preset Bolus deliveries on page 86 To deliver a Preset Bolus 1 2 Go to the Home screen Select Bolus The Bolus screen appears Select Preset Bolus The existing preset bolus settings appear showing your current BG value if applicable and any insulin that is still active from previous boluses For more information about active insulin see About active insulin on page 72 Select the Preset Bolus you want to deliver Verify your bolus amounts and then select Deliver Bolus Your pump beeps or vibrates and displays a message when your bolus starts Stopping a bolus delivery The following procedures describe how to stop a Normal bolus or a Dual Wave bolus during the
72. Teknoloji Ticaret Ltd Sirketi Tel 90 216 4694330 USA Medtronic Diabetes Global Headquarters 24 Hour HelpLine 1 800 646 4633 To order supplies 1 800 843 6687 Ukraine Med EK Service Ltd Tel 380 44 545 7705 United Kingdom Medtronic Ltd Tel 44 1928 205167 Osterreich Medtronic Osterreich GmbH Tel 43 0 1 240 44 0 24 Stunden Hotline 0820 820 190 Cesk republika Medtronic Czechia sro Tel 420 233 059 401 Non stop help line 420 233 059 059 MP6025957 024 A Contents B Before you begin 3 A OW WN NH A 10 10 12 13 13 14 15 15 Using this user guide Emergency kit User safety Indications Contraindications General warnings General precautions Adverse reactions Notice Keeping track of your system information Insulin guidelines Consumables Optional devices Accessories Ordering supplies and accessories B First steps 19 20 21 22 23 Your pump Using the buttons About batteries Inserting the battery Removing the battery Contents E A le eh Uu MP6025957 024 A 24 24 26 26 28 2 32 34 34 33 B Basal 39 40 4 4 42 46 46 47 47 48 49 22 52 54 B Bolus 59 59 60 61 vi Getting to know your pump Entering your startup settings Unlocking your pump Home screen Status bar Status screens Using the Menu screen Scroll bar Power modes If you remove your pump Basal rate Basal insulin settings
73. a period of time after giving a manual injection of insulin by syringe or pen Manual injections are not accounted for in the active insulin amount Therefore the Bolus Wizard could prompt you to deliver more insulin than needed Too much insulin may cause hypoglycemia Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard For details on pump safety see User safety on page 5 User safety Indications MiniMed 640G system The MiniMed 640G system is indicated for the continuous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin In addition the system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin and detecting possible low and high glucose episodes When using a sensor and transmitter the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management This data can be uploaded to a computer for analysis of historical glucose values The continuous sensor glucose values provided by the MiniMed 640G system are not intended to be used directly for making therapy adjustments Rather they provide an indication that a confirmation fingerstick measurement may be required All therapy adjustments should be based on measurements
74. abdomen surrounding your belly button Rotate infusion set insertion sites by starting at 12 o clock and then rotate the site clockwise to 3 o clock 6 o clock and so on e Imagine a letter M or a letter W on either side of your belly button Start at the end of one letter and proceed through the letter rotating to each intersection in turn MW Medtronic Diabetes offers a variety of infusion sets for your pump The instructions for the Quick set infusion set are provided here as an example After your infusion set is inserted see Filling the cannula on page 105 to fill the infusion set cannula 104 Chapter 5 MP6025957 024 A Quick set infusion set with Quick serter There are different infusion sets that you can use with your pump As an example the following procedure shows how to insert the Quick set infusion set Always refer to the instructions that shipped with your infusion set Filling the cannula Filling the soft cannula with insulin is required after the infusion set is inserted into your body and the introducer needle is pulled out The insulin amounts required to fill the cannula depend on the type of infusion set you are using Refer to your infusion set instructions for this information Reservoir and infusion set 105 D un M 3 lt o 5 5 N M er MP6025957 024 A gt Note If you are using an infusion set with a needle you do not need to
75. ach or fall below a level that is 1 1 mmol L above your low limit within approximately 30 minutes Responding to a Suspend before low event When you clear the Suspend before low alert the SmartGuard suspend by sensor icon Q flashes and Suspended before low appears on your Home screen If your 5G reaches your low limit an Alert on low occurs When a Suspend before low event occurs insulin delivery will remain suspended for at least 30 minutes unless you manually resume your basal delivery For details see Manually resuming basal delivery during a suspend by sensor event on page 174 After the minimum 30 minute suspend time basal insulin delivery will automatically resume if the following conditions are met Your SG is at least 1 1 mmol L above your low limit Your SG is estimated to be more than 2 2 mmol L above your low limit within 30 minutes Setting up Continuous Glucose Monitoring 159 M m c e o A le 5 ct 5 un A un b le er e MP6025957 024 A Your basal insulin delivery will be suspended for a maximum of two hours unless these criteria are met during the suspend or unless you manually resume your basal insulin For details see Manually resuming basal delivery during a suspend by sensor event on page 174 IF you do not respond to the Suspend before low alert your pump resumes insulin delivery after two hours and displays a Basal delivery resu
76. ading began The battery in the pump is low on power Next steps e Remove the reservoir and select Rewind to restart the fill tubing process e Disconnect tubing from reservoir e Be sure tubing is not crimped or bent e Continue following the steps displayed on the pump using the same infusion set and reservoir e If this alarm occurs again use a new infusion set If a fill tubing delivery was in progress when the alarm occurred e Check the Daily History screen for the amount of bolus already delivered before the pump alarmed e Consider delivering remaining bolus if the bolus insulin was not included in an insulin injection Remove the reservoir to start again Select Rewind and follow the on screen instructions Select OK to clear the alert e Replace the AA battery as soon as possible Otherwise insulin delivery stops and the Replace Battery Now alarm occurs e If the pump is delivering a bolus or filling the cannula wait until delivery is complete to replace battery Alarms alerts and messages 209 EY s 2 D et di gt 3 D N M MP6025957 024 A Title and text Low reservoir XX hours remaining Change reservoir or XX units remaining Change reservoir Manage settings error Delivery stopped Backup settings cleared from Manage Settings Current settings are working properly Select OK
77. al Wave bolus with the Bolus Wizard The Dual Wave option is available in the Bolus Wizard only after you turn on the Dual Wave feature To deliver a Dual Wave bolus with the Bolus Wizard 80 For a correction bolus or afood bolus with a correction use your BG meter to check your blood glucose For a food bolus only skip this step Go to the Bolus Wizard screen Home screen Bolus Bolus Wizard The Bolus Wizard screen shows your current BG meter reading if applicable and any insulin that is still active from previous boluses For more information about active insulin see About active insulin on page 72 For more information see About your compatible Bayer meter on page 111 Y Note Be aware that if you already have the Bolus Wizard open prior to wirelessly sending your BG meter reading to your pump you must close the Bolus Wizard and open it again in order for that reading to appear If you are not using a wirelessly connected compatible Bayer meter you can select BG to manually enter your BG meter reading Chapter 4 MP6025957 024 A J Note If you choose not to enter a BG value three dashes appear on the screen in place of the BG value For a food bolus select Carbs to enter the carb count of your meal For a correction bolus where no food was eaten leave the Carbs value as 0 Review your calculated Bolus amount If you want to change the amount select Bolus and make your desired change
78. alues you entered for the last SG Review or the default values of 10 mmol L for the High Limit and 3 9 mmol L for the Low Limit Chapter 7 MP6025957 024 A SG Review Low Li m it 3 JQ mmol L Days to Average 1 Next Enter the High Limit and Low Limit that you want to use for the sensor glucose review There must be a minimum of 1 1 mmol L difference between the high and low SG limits Enter the number of days of sensor glucose history to average and select Next A graph of your SG data appears If you specified one day of history to view the graph shows details about when your SG was above below or within your specified limits You can scroll down to view the number of hours and percentage of time you were above within and below your SG limits If you have no data saved a message appears on the screen letting you know there is no data available SG Review 49 12 1 1 L Y Fri Jan 18 If you view information for multiple days the graph shows the average percentage of time that your SG was above below or within your specific limits History and events 123 N et 2 lt 0 5 b lt b et N MP6025957 024 A oG Review 7 Days Avg Day Se Within 9 00 hr 38 ISIG History ISIG represents a signal measured by the sensor that is used to calculate your sensor glucose value The ISIG History feature shows the history of your ISIG values over the pr
79. an insulin injection Monitor your BG 72 Chapter 4 MP6025957 024 A Warning What it means What to do Low BG Your BG meter reading is below Treat your low BG Do not give 3 9 mmol L yourself a bolus until your BG returns to normal Max Bolus The bolus amount entered Check the bolus amount Select Exceeded exceeds your Max Bolus setting to cancel or Yes to continue If you select Yes the bolus amount that you entered is reduced to your max bolus limit Let your healthcare professional know if you routinely receive the Max Bolus exceeded warning so that they can adjust your pump settings Note In the event that you do not clear the High BG Low BG or Max Bolus exceeded warning the warning will remain on your pump indefinitely If you clear the message after more than 12 minutes have passed do not deliver the bolus amount shown That bolus amount was based on a BG value that is no longer current Instead return to the Home screen and check your BG again with your meter Enter the new value into the Bolus Wizard and give a bolus if needed Normal bolus A Normal bolus provides a single immediate dose of insulin You use a Normal bolus to cover your food intake or to correct a high BG meter reading You cannot access the Reservoir amp Tubing Insulin Settings or Sensor Settings menu options during a Normal bolus delivery Note Your pump allows you to deliver a Normal bolus while a Square Wave bolus or t
80. and then selecting Quick Status Go to the Basal Patterns screen Home screen gt Basal gt Basal Patterns Basal Patterns screen shows the basal patterns you have set up and the 24 hour insulin total for each basal pattern A check mark appears next to the active basal pattern Basal Patterns To see the individual basal rates select the desired basal pattern Basal 53 MP6025957 024 A Stopping and resuming your insulin delivery Use Suspend Delivery if you need to stop all active basal and bolus insulin deliveries When you suspend your insulin delivery your pump beeps and vibrates every 15 minutes to remind you that insulin is not being delivered When you are ready to continue your basal insulin delivery use the Resume feature When you use the Resume feature your pump starts your programmed basal pattern but does not start any previously programmed bolus deliveries Note If you want to stop a bolus delivery only without stopping your basal delivery see Stopping a bolus delivery on page 88 WARNING A bolus delivery or fill cannula that was suspended does not restart when you resume To avoid a high BG and ketoacidosis always check the pump s Daily History after you resume insulin delivery to determine the amount that was delivered If needed program a new bolus or fill cannula delivery A Caution When using Audio or Vibrate it is possible that an Audio or Vibration notification may not o
81. appear in the list but are not available for use Basal 5 MP6025957 024 A 2 Select the preset temp basal rate that you want to use and then select Begin emp 1 0 100 U hr for 0 30 hr End Temp U hr 17 39 0 100 Your preset temp basal rate continues for the duration you set The Basal option on the Home screen appears as Basal T during your preset temp basal delivery Your scheduled basal rate automatically starts again when your preset temp basal rate finishes Canceling a Temp Basal or Preset Temp basal rate You can cancel a temp basal or preset temp basal rate at any time When you do so your scheduled basal pattern automatically starts again To cancel a temp basal rate 1 Go to the Basal screen Home screen Basal T The Temp Basal screen displays the name Preset Temp only current basal rate the set duration and the remaining time 2 Select Cancel Temp Basal Viewing your basal information The following table describes how you can view your basal rates and patterns 52 Chapter 3 MP6025957 024 A To do this View your current basal rate View your basal patterns Do this Go to the Basal screen Home screen Basal The active basal pattern and current basal rate appear at the top of the Basal screen Current Rate 0 025 ushr Basal Patterns Insulin Settings You can also view your current basal rate by selecting the Status Bar at the top of the Home screen
82. ars Insulin that is continuously delivered by the pump to meet your individual insulin needs between meals and during sleep A set of one or more basal rates that covers a 24 hour period The amount of continuous basal insulin that you program your pump to automatically deliver per hour Abbreviationfor blood glucose See blood glucose The high and low values to which your blood glucose is corrected when using the Bolus Wizard A feature that restricts the ability to change all settings You can still perform certain functions such as suspending insulin delivery reviewing history testing your pump or clearing alarms and alerts Refers to glucose sugar that is present in the blood commonly measured by a blood glucose meter A device that measures glucose levels in the blood A reminder that you set just after you program a bolus The reminder notifies you to check your blood glucose when the time period that you specified has passed Insulin used to cover an expected rise in glucose levels from carbohydrates or to lower a high blood glucose value down to your target range A feature that lets you choose the speed at which your device delivers bolus insulin MP6025957 024 A Bolus Wizard calibrate Calibration reminder cannula carb ratio carb unit CGM continuous glucose monitoring CGM correction bolus Daily History Dual Wave Bolus Easy Bolus Event Marker A feature th
83. assistance with your pump Select OK to go to the Time amp Date screen Enter the current time time format and date Alarms alerts and messages 211 EY s 2 D et di gt 3 D N M MP6025957 024 A Title and text Pump error Delivery stopped Current settings cleared Pump restart needed Select OK to restart and then re enter your settings See User Guide Pump error Delivery stopped Settings unchanged Pump restart needed Select OK to restart See User Guide 212 Chapter 12 Explanation Your pump encountered an error and will restart Your pump settings will return to factory default values A pump error has occurred you need to restart your pump Next steps When the pump restarts follow instructions on the pump display After restart check settings and re enter values as needed If you recently saved backup settings in Manage Settings use Restore Settings e If the pump was delivering a bolus or filling the cannula check Daily History and reevaluate your need for insulin e If this alarm recurs frequently write down the error code displayed on the alarm screen you can also find it in your Alarm History and contact your local representative for assistance with your pump Select OK to restart your pump e If the pump was delivering a bolus or filling the cannula check Daily History and
84. at uses your individual Bolus Wizard settings to calculate an estimated bolus amount based on the BG values and carbs that you enter These settings include Carb Ratio Insulin Sensitivity Factor BG Target Range and Active Insulin Time The process of using a meter blood glucose reading to calculate sensor glucose values A reminder you can set to let you know when your next calibration is due Short thin and flexible tube placed in the tissue below the skin Insulin is delivered through the cannula into the body The number of grams of carbohydrates covered by one unit of insulin The carb ratio is used to calculate bolus amounts The unit of measure for carbohydrates either grams or exchanges exch Abbreviation for continuous glucose monitoring See continuous glucose monitoring A monitoring tool that uses a glucose sensor placed below the skin to continuously measure the amount of glucose in your interstitial fluid Insulin used to lower a high blood glucose value down to your target range A feature that displays the actions that you performed using your device A type of bolus that provides a dose of insulin delivered as a combination of a Normal Bolus followed by a Square Wave Bolus A feature that lets you deliver a Normal Bolus in preset increments using only audio or vibrate confirmation A feature that allows you to record events such as blood glucose readings injections carbohydrates and
85. ax 47 67 10 32 10 Medtronic B V Tel 4 7 495 580 73 77 24h 8 800 200 76 36 Philippines Medtronic International Ltd Tel 65 6436 5090 or 65 6436 5000 Polska Medtronic Poland Sp Zoo Tel 48 22 465 6934 Portugal Medtronic Portugal Lda Tel 351 21 7245100 Fax 351 21 7245199 Puerto Rico Medtronic Puerto Rico Tel 787 753 5270 Republic of Korea Medtronic Korea Co Lia Tel 82 2 3404 3600 Romania Trustmed SRL Tel 40 0 21 220 6477 Schweiz Medtronic Schweiz AG Tel 41 0 31 868 0160 24 Stunden Hotline 0800 633333 Fax Allgemein 41 0 318680199 Serbia Epsilon Tel 381 11 311 5554 Fax 381 11 311 5554 Serbia Medtronic BV Serbia Tel 381 11 2095 900 Fax 381 11 2095 985 Singapore Medtronic International Ltd Tel 65 6436 5090 or 65 6436 5000 Slovenija Zaloker amp Zaloker brezpla na tevilka 080 1880 Tel 386 1 542 51 11 24 h 386 51 316 560 Slovensk republika Medtronic Slovakia s r o Tel 421 26820 6942 HelpLine 421 26820 6986 Sri Lanka Swiss Biogenics Ltd Mobile 4 91 9003077499 or 94 777256760 Suomi Medtronic Finland Oy Tel 4 358 20 7281 200 Help line 4 358 400 100 313 Sverige Medtronic AB Tel 4 46 8 568 585 20 Fax 46 8 568 585 11 Taiwan Medtronic Taiwan Ltd Tel 886 2 2183 6068 Toll Free 886 0800 005 285 Thailand Medtronic Thailand Ltd Tel 662 232 7400 T rkiye Medtronic Medikal
86. be wirelessly connected and the Remote Bolus option on your pump must be turned on Consult your healthcare professional before using the Remote Bolus feature The following procedure describes how to turn the Remote Bolus feature on or off For information on using Remote Bolus user guide that came with your compatible Bayer meter 2 Note Remote Bolus default setting is on To turn on or off Remote Bolus 1 Make sure that your pump and compatible Bayer meter are connected 2 the Remote Bolus screen Menu Utilities Remote Bolus The Remote Bolus screen appears 3 Select Remote Bolus to turn the feature on or off 4 Select Save Deleting a meter from your pump Follow this procedure to delete your compatible Bayer meter from the pump To delete the meter from the pump 112 Chapter 6 MP6025957 024 A 1 Go to the Manage Devices screen Menu Utilities Device Options Manage Devices The Manage Devices screen appears 2 Identify and select your meter by the serial number See your compatible Bayer meter user guide for instructions on locating your serial number 3 Select Delete 4 screen appears confirming that you would like to delete the device Select Yes to confirm or No to cancel Meter 113 MP6025957 024 A 114 Chapter 6 history and events MP6025957 024 A MP6025957 024 A History and events This chapter describes the History and Event Markers featu
87. bing for cracks or damage 4 Review the status screen basal rates and other pump settings 5 Perform the Self Test procedure by going to 230 Chapter 13 MP6025957 024 A Menu Utilities Self Test For details see Self Test on page 145 6 If the Self Test does not complete successfully or if you are concerned about your pump call your local representative for assistance and check your BG cannot get to the Manage Settings screen If you go to Menu Utilities Manage Settings a message appears telling you that the feature is not normally accessible and to consult your user guide To access the Manage Settings screen 1 Menu gt Utilities gt Manage Settings 2 Simultaneously press and hold gt and for about two seconds The Manage Settings screen appears For more information see Managing your pump settings on page 142 My pump display times out too quickly Your pump display times out after 15 seconds by default in order to conserve battery power You can increase this setting up to three minutes Go to Menu Utilities gt Display Options and then adjust the Backlight setting as desired For more information see Display Options on page 141 Note Be aware that using a longer Backlight time causes your pump to use more battery power When your pump battery is low the timeout for the backlight on your pump screen is automatically reduced Where is my pump status screen 1 To go to the Status scr
88. blood glucose Home screen 26 sensor calibration 185 bolus about 59 daily delivery amount 118 delivery speed 63 history 117 118 increment setting 63 64 Max bolus 62 reminders 131 setting delivery speed 63 settings 62 summary 117 118 types 59 Bolus BG Check reminder about 130 bolus deliveries about 59 Bolus Wizard 61 65 delivery rate 63 Dual Wave 79 Easy Bolus 62 83 Manual Bolus 61 75 Max Bolus setting 62 Normal bolus 73 75 options 6 Preset Bolus 61 86 resume message 214 215 Square Wave 76 stopping 88 types 59 Bolus not delivered alarm 204 Bolus stopped alarm 204 bolus types DualWave 60 examples 60 Normal 59 Square Wave 60 Bolus Wizard Active Insulin Time 66 BG target 66 Carb ratio 66 Dual Wave 80 Exchange ratio 66 High BG warning 72 injection warning 72 Insulin Sensitivity Factor 66 Low BG warning 73 Max Bolus Exceeded warning 73 Normal bolus 73 Square Wave 77 warnings 72 C calibrate error 220 221 sensor 184 when to 186 Calibrate now alert 219 calibration guidelines 187 icon 30 Calibration not accepted alert 219 Calibration reminder 133 Cannot connect device alert 204 Cannot find sensor signal alert 220 cannula alarm 205 carb ratio 69 Carb Units 140 CareLink Personal Software 124 Change sensor alert 220 Check connection alert 221 Check settings alert 204 cleaning pump 241 transmitter 242 Index 289 MP6025957 024 A clearing active insulin 144 pump settings 143 Conne
89. can change the language that your pump uses to display information To change the Language setting 1 Goto the Language screen Menu Utilities Language General settings 141 D 5 2 N M et a Q N MP6025957 024 A A checkmark indicates which language is active 2 Select your desired language 3 Select Yes when the confirmation message appears Managing your pump settings Manage Settings lets you save restore or clear your settings The following table describes the Manage Settings options Save Settings Saves a record of your current settings that you can use if a future event requires you to re enter your settings Restore Settings Allows you to restore your settings using the backup settings that you saved using the Save Settings feature Clear All Erases your settings and returns them to the factory defaults Settings To use your pump again after clearing all settings you must use Restore Settings This enables you to restore a previous version of your settings or enter your settings again Clear Active This option appears only if you have never cleared your Insulin active insulin Use this feature when you are ready to use your pump with insulin for the first time You can only clear your active insulin once Settings History Displays a history of recent activities that relate to managing your settings such as saving clearing and restoring your settings Saving your setting
90. ccur as expected if the speaker or vibrator in your pump malfunctions This is most important when using the Easy Bolus feature or when your pump is in Manual Suspend where a missed notification may cause an over or under delivery of insulin Contact the 24 Hour HelpLine or your local representative with any concerns To suspend all insulin delivery 1 Go to the Suspend Delivery screen Menu Suspend Delivery 2 A confirmation message appears To suspend your pump and stop all insulin delivery select Yes The Home screen indicates that your insulin is suspended Your pump functions are limited until you resume your insulin delivery 54 Chapter 3 MP6025957 024 A To resume basal insulin delivery 1 p While insulin is suspended go to the Home screen Select Resume A confirmation message appears To resume your basal insulin delivery select Yes If a Temp Basal was active when you suspended your pump it resumes if the time is still within the duration that you set Note If you still need a bolus delivery that was in progress before you suspended your delivery check the Daily History screen for the actual bolus units delivered and the intended bolus amount Then you can set up a new bolus amount as needed See Daily History on page 121 for details about using the Daily History screen Basal 55 MP6025957 024 A 56 Chapter 3 MP6025957 024 A sn oq MP6025957 024 A MP6025957 024 A
91. conditions suivantes 1 l appareil ne doit pas produire de brouillage et 2 l appareil doit accepter tout brouillage radio lectrique subi m me si le brouillage est susceptible d en compromettre le fonctionnement Keeping track of your system information The serial number SN is located on the back of your pump If you are using the belt clip you need to remove the belt clip to view the serial number It also displays in your Pump status screen For more details on the status screens see Status screens on page 31 For future reference enter the serial number of your pump and the purchase date in the following table 12 Chapter 1 MP6025957 024 A Pump serial number and purchase date Serial Number Purchase Date Insulin guidelines WARNING Never start on insulin until directed by your healthcare professional Doing so could result in an unintended delivery of insulin which may cause hypoglycemia The pump is intended for use with U100 insulin The following insulins have been tested by Medtronic Diabetes and found to be safe for use with the MiniMed 640G insulin pump Humalog NovoLog NovoRapid Before using different insulin with this pump check the insulin label to make sure the insulin can be used with the pump Consumables The pump uses disposable single use MiniMed reservoirs and infusion sets for insulin delivery WARNING Only use reservoir and infusion sets manufactured by Medtron
92. cription Suspend before low average number of Suspend before low events per day The Daily History screen displays a list of actions you performed on your pump or event entries that you made for the selected day such as your BG meter readings bolus deliveries any temp basal rates you have used and so on The list displays the most recent action or event first From this list you can display further details Suspend on low The average number of Suspend on low events per day Time suspended by average duration amount of time suspended as a result of m sensor Suspend on low or Suspend before low events per day et SG readings Number of SG readings per day E CU a Daily History x a about any action or event To view your Daily History 1 Go to the Daily History screen Menu gt History gt Daily History A list of dates appears 2 Select a specific date of history to view A list appears with any pump actions or events entered on the specified day 3 You can select any item in the list to open the Detail screen which displays more information about the selected action or event For example if you view the details of a bolus delivered using the Bolus Wizard the Detail screen shows you all of the data associated with that bolus such as the BG correction amount active insulin adjustment carbs entered and calculated bolus History and events 121 MP6025957 024 A Alarm History The Ala
93. ct Device message 226 connecting pump transmitter automatically 175 manually 179 connection failure 178 Consumable infusion set 13 reservoir 13 continuous glucose monitoring about 15 airplane mode 137 alarms 216 alerts 216 calibrating sensor 184 connecting pump transmitter 175 examples 165 High Settings 156 home screen 153 Low Settings 157 messages 216 sensor feature turning on 167 sensor glucose reading 191 sensor graph 191 settings 156 correction estimate 251 252 Critical pump error 205 D Daily History 121 date changing 148 Startup Wizard 24 delivery stop bolus 33 suspend all 33 Delivery limit exceeded alarm 205 Display Options setting up 141 Download slow alert 226 290 Index Dual Wave 60 about 79 Bolus Wizard 80 example 60 Manual bolus 82 resume message 214 215 setting Up 80 E Easy bolus about 83 Manual bolus 85 setting Up 84 step size 83 electromagnetic emissions 262 Electromagnetic environment 267 268 electromagnetic immunity 263 emergency kt 4 siren 201 emergency kit 4 emissions 262 event markers about 124 blood glucose 125 exercise 125 food 125 injection 125 setting up 124 exchange ratio 69 Fill Cannula alarm 205 food estimate 251 252 253 G glucose alerts silencing 193 graph sensor 191 H High BG Bolus Wizard warning 72 High Limit SG setting 157 MP6025957 024 A High Settings about 156 entering 167 history about 117 menu 33
94. ct Remote Bolus to turn the feature on or off 6 Select Save Carb Unit The Carb Unit setting determines whether to enter and display carbohydrates in grams g or exchanges exch You enter carbohydrate information when using the Bolus Wizard and recording food in Event Markers To change the Carb Unit setting 1 Go to the Carb Unit screen 140 Chapter 9 MP6025957 024 A Menu gt Utilities gt Carb Unit 2 Select either Grams or Exchanges 3 Select Save Display Options The Display Options allow you to increase or decrease the brightness of your screen From the Display Options screen you can also adjust the amount of time the backlight stays on after you press a button To adjust the display options 1 Go to the Display Options screen Menu Utilities Display Options 2 Select Brightness to adjust the brightness of your screen You can set a level from 1 to 5 or select Auto to have the screen automatically adjust to your current environment Note The brightness setting you select can affect the life of your battery For a longer lasting battery consider using a lower level setting 3 Select Backlight to adjust the timeout for the backlight on your pump screen You can select 15 seconds 30 seconds 1 minute or 3 minutes Note The backlight can affect the life of your battery For a longer lasting battery consider setting the screen timeout to 15 seconds 4 Select Save Language You
95. ctive Insulin Curve Product specifications and safety information 253 Lo 5 je Q c A et Uu Lo A e A 0 lo un 0 Q N et lt O 3 0 le MP6025957 024 A Active Insulin Curve 8 Hour 7 Hour 6 Hour 5 Hour 4 Hour 3 Hour 2 Hour E tc 3 aS 4 5 Time hours Graph adapted from Mudaliar and colleagues Diabetes Care Volume 22 Maximum ratio settings 1 to 200 grams unit 0 075 to 15 units exch Delivery accuracy 254 Delivery accuracy for basal rate is 3 596 Delivery accuracy for bolus volumes lt 0 1 unit is 20 and delivery accuracy for bolus volumes gt 0 1 unit is 3 596 All Normal boluses are delivered within 50 minutes 3 seconds at Standard rate 75 units at 1 5 units per minute and within 5 minutes 3 seconds at Quick rate 75 units at 15 units per minute The maximum infusion pressure generated and the occlusion threshold pressure is 86 12 kPa 12 49 psi The bolus volume generated is 0 01225 mL Chapter 15 MP6025957 024 A he following is a representative delivery accuracy curve Trumpet Curve for MMT 1511 1512 Percent Error 96 0 10 20 30 40 50 60 70 80 90 100 Observation Window Minutes Easy Bolus 5 O o c e et Uu o A e zh A 0 O un 0 5 o Uu _ er lt 5 O um
96. d attached to the reservoir compartment on your pump remove it now 4 Turn the tubing connector a half turn counter clockwise then pull the reservoir and connector out from the pump tubing connector 5 Dispose of the used reservoir and infusion set according to local regulations Rewinding your pump WARNING Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing Never insert the reservoir into the pump while the tubing is connected to your body Doing so could result in an accidental infusion of insulin which may cause low BG When you rewind your pump the piston in the reservoir compartment returns to its starting position and allows a new reservoir to be placed into the pump 94 Chapter 5 MP6025957 024 A Note The piston is located in the reservoir compartment of your pump lt engages the reservoir and pushes insulin through the tubing piston ES SRI V PA AA D NS S To rewind your pump 1 Goto the New Reservoir screen Menu Reservoir amp Tubing New Reservoir The New Reservoir screen appears If you have not yet removed the infusion set and reservoir do so now D un M lt o 2 5 c v o N M et New Reservoir 1 Remove infusion set from body 2 Remove reservoir from pump 2 Select Rewind The piston in the r
97. d cannot be changed by the user Units First reminder occurs at 5 to 50 units Second 1 unit 20 units reminder occurs at 50 percent of the remaining specified amount The second reminder is automatic and cannot be changed by the user Max Bolus Range Default Normal bolus O to 75 units 10 units Range is 0 025 to 75 units of insulin and limited by the Max Bolus setting Occlusion detection When occlusion is detected the Insulin flow blocked alarm occurs The occlusion alarm is triggered by an average of 2 23 units of missed insulin standard bolus or 1 97 units of missed insulin quick bolus The MiniMed pump is intended for use with U100 insulin This table shows occlusion detection for four different situations when using U100 insulin Rate bolus delivery 10 units at standard speed bolus delivery 10 units at quick speed basal delivery 1 0 u h basal delivery 0 025 u h 258 Chapter 15 Minimum time before alarm 71 seconds 9 seconds 2 00 hours 123 38 hours Average time before alarm 95 seconds 10 seconds 2 50 hours 142 03 hours Maximum time before alarm 136 seconds 14 seconds 3 80 hours 178 33 hours MP6025957 024 A Percent temp basal The default value is 100 percent of basal programming Range 0 to 200 Default 100 of basal programming Increment 5 Program safety checks A single fault condition will cause the pump to suspend insulin
98. d for determining if insulin delivery should be suspended A feature that allows you to enter and deliver a dose of insulin in the amount that you have determined is necessary A feature that allows you to set the maximum amount of basal insulin that can be delivered per hour A feature that allows you to set the maximum bolus amount that can be delivered in one dose A term for any blood glucose meter MP6025957 024 A Missed Meal Bolus reminder Normal Bolus notifications occlusion piston Power save mode Preset Bolus Preset Temp Basal Rate alert reminder reservoir Resume basal alert A reminder that a bolus was not delivered during time periods that you specify often set around your meal times A type of bolus that provides an entire dose of insulin immediately All notifications are designed to get your attention and convey different types of information They include alarms alerts reminders and messages A blockage or crimp of the cannula or tubing that prevents proper insulin flow The part of the insulin pump that engages the reservoir and moves insulin through the tubing A state in which your pump is fully functional but the screen goes dark to save power You can set how long it takes for your screen to enter power save mode by changing the Backlight setting A feature that allows you to set up and save a bolus for specific meals or snacks that you frequently eat or drink
99. decision When a message occurs Start new sensor Display The pump displays a notification with a blue icon and instructions Notification light Does not illuminate or blink Audio Depending on the message the pump emits a message tone an alert tone or no tone Depending on your Audio Options settings you may hear a tone feel a one pulse only vibration or hear a tone and feel a vibration You clear the message by pressing v a selection Pump alarms alerts and messages The following table lists the most common or serious alarms alerts and messages related to your pump The table also explains the meaning consequences and the reasons why these notifications appear and provides steps for problem resolution 202 Chapter 12 MP6025957 024 A Title and text Active Insulin cleared Any Active Insulin amount has been cleared Auto Suspend Insulin delivery suspended No buttons pressed within time set in Auto Suspend Battery failed Insert a new AA battery Battery not compatible See User Guide Explanation An alarm has cleared your active insulin amount Your active insulin amount is now at O units You have not pressed any buttons during the time specified in the Auto Suspend settings The pump battery does not have enough power The battery that you inserted into the pump is not compatible Next steps Select OK to clear the alarm
100. dy Consider other insulin treatment See User Guide Delivery limit exceeded Delivery stopped Check BG See User Guide for more information Fill Cannula Select Fill to fill cannula or select Done if not needed Insert battery Delivery stopped Insert a new battery now Explanation Your pump has encountered a critical error You have attempted to deliver more insulin than expected basegeoN your Max Bolus and Max Basal settings You had the Fill Cannula screen displayed for 15 minutes The battery was removed from the pump Next steps The pump is not able to deliver insulin Remove your infusion set and stop using your pump Consider another form of insulin delivery e Check your BG and treat as necessary e Write down the error code that appears on the alarm screen e Call your local representative for assistance with your pump e Check your BG Select Resume Basal e Check Bolus History and reevaluate your need for insulin e Continue to monitor your BG e To proceed and fill the cannula select Fill If you do not need to fill the cannula select Done to skip this process e Insert a new AA battery alarm clears when you insert a new battery pump powers off after 10 minutes unless you insert a new battery Alarms alerts and messages 205 EY s 2 D et di gt D un M un MP6
101. e 184 e Your pump has lost connection to the sensor Move your pump closer to the sensor For more details see My pump cannot find the sensor signal on page 234 The sensor glucose value received was outside the expected range and was not displayed Select OK to clear the alert If the issue continues you may need to replace the sensor If the issue persists call your local representative for assistance Troubleshooting 237 E le c N gt O le tQ MP6025957 024 A 238 Chapter 13 MP6025957 024 A MP6025957 024 A MP6025957 024 A Maintenance Read your warranty statement included with your pump for information about 3 5 et D Y gt A M what is covered during your warranty period Cleaning your pump Make sure you have th ving supplies ready for cleaning your pump three or four small clean soft cloths a mixture of water with a mild detergent clean water 70 alcohol and a few clean cotton tips and cotton balls To clean your pump 1 Dampen a cloth with water mixed with a mild detergent Using the cloth wipe the outside of the pump Dampen a clean cloth with water and wipe to remove any detergent residue Wipe your pump with a 7096 alcohol wipe for disinfection 2 3 4 Dry with a clean cloth 5 6 Using a dry clean cotton tip remove any battery residue from the battery cap Using a dry clean cloth remove any battery
102. e are four different formulas the Bolus Wizard feature uses to estimate a bolus depending on your current BG The following formulas apply only when the carb units are in grams 1 If your current BG is greater than your High BG Target the Bolus Wizard feature subtracts active insulin from the BG correction estimate then adds this to the food estimate to get the total bolus estimate However if the result of subtracting active insulin from BG correction estimate is a negative number less than zero the total bolus estimate is based only on the food estimate Product specifications and safety information 251 MP6025957 024 A 252 food estimate correction estimate total bolus A C D p estimate B 4 EC active insuli where A food grams B carb ratio C current BG D High BG Target E insulin sensitivity Food estimate Carb grams Carb ratio Units of insulin Correction estimate Current BG High BG Target Insulin sensitivity Active insulin 2 Units of insulin Total bolus estimate Food estimate Correction estimate Units of insulin If your current BG is less than your Low BG Target the Bolus Wizard feature adds the BG correction estimate to the food estimate to get the total bolus estimate food estimate correction estimate total bolus A C D estimate B T E where A food grams B carb ratio C current BG D Low BG Target E insulin sensitivity Food estimate Carb g
103. e following happens when you start the search process On your pump a message appears to let you know your pump is searching Chapter 10 MP6025957 024 A e On your transmitter a green light flashes briefly and then turns off Note The search process can take up to two minutes You cannot access your pump screens or suspend your pump during the search process 6 Place the transmitter next to the pump If the connection is successful your pump displays a success message If the Sensor feature is turned on the Connection icon T appears on the status bar If your pump does not connect to your transmitter 1 If your pump does not connect to the transmitter do one of the following Select Retry to return to the Enter Device SN screen on your pump and then return to step 4 of the procedure above and follow the instructions to search again Select Cancel to return to the Connect Device screen where you search again using Manual Connect or Auto Connect 2 f you have tried to connect multiple times without success see My pump cannot find the sensor signal on page 234 Deleting the transmitter from your pump Follow this procedure to delete the transmitter from your pump Use this process when you are replacing your transmitter To delete your transmitter from your pump 1 Go to the Manage Devices screen Menu Utilities Device Options Manage Devices Setting up Continuous Glucose Monitoring
104. e for the higher frequency range applies Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Wireless communication Quality of service The CGM transmitter and MiniMed insulin pump are associated as part of an 802 15 4 network for which the pump functions as the coordinator and the CGM transmitter as an end node In an adverse RF environment the MMT 1511 1711 pump will assess channel changing needs based on noise levels detected during 268 Chapter 15 MP6025957 024 A an energy scan The pump will perform the energy scan if after 10 minutes no CGM transmitter signal has been received If the channel change occurs the pump will send beacons on the new channel The CGM transmitter will initiate a channel search when beacon detection fails on the associated channel The search will be conducted across all five channels When the beacon is located the transmitter will rejoin on the identified channel Upon re association any missed packets up to 10 hours will be transmitted from the CGM transmitter to the pump In normal operation the CGM transmitter will transmit a packet every 5 minutes and retransmit the packet if the data is corrupted or missed Radio frequency RF communications specifications Utilizes the IEEE 802 15 4 protocol with the proprietary data format Pump frequency 2 4 GHz proprietary Medtronic protocol
105. e to enter my settings Troubleshooting sensor issues My pump cannot find the sensor signal Calibration not accepted Why does the SmartGuard suspend by sensor icon on my Home screen appear gray Contents MP6025957 024 A m Maintenance 241 242 242 243 Cleaning your pump Cleaning your transmitter Storing your pump Storing your transmitter B Product specifications and safety information 247 247 248 248 249 249 250 250 250 251 221 254 254 225 255 256 256 256 251 257 258 258 258 259 Product specifications Alarm and alert escalation Altitude range Audio frequency Backlight Basal delivery BG Target BG meter value Bolus delivery Bolus Wizard feature default settings Bolus Wizard feature specifications Carb ratios Delivery accuracy Easy Bolus Environmental conditions Filling the infusion set and cannula Infusion pressure Insulin delivery default settings Insulin sensitivity factor Low Reservoir reminder Max Bolus Normal bolus Occlusion detection Percent temp basal Contents xi E A gt ct D un MP6025957 024 A 239 259 259 259 260 262 268 268 269 269 270 Program safety checks Pump dimensions Pump memory Pump weight Sensor default settings Guidance and manufacturer s declaration Wireless communication Quality of service Radio frequency RF communications specifications Data security Icon table B Appendix A End u
106. e total amount of bolus insulin you can program for a single bolus delivery For details about setting the max bolus amount see Max Bolus on page 63 MP6025957 024 A Setting Bolus Increment Bolus Speed Max Bolus What it is The amount of insulin in units that is increased or decreased with each button press when adjusting your bolus amount The Bolus Wizard will also use the increment to display the bolus total and adjustment amounts This setting does not apply to Easy Bolus The speed that your pump delivers your bolus insulin What it does for you Allows you to set your increment value according to your typical bolus amounts For details about setting the bolus increment see Bolus Increment on page 64 Allows you to set your bolus insulin delivery speed to Standard or Quick For details about setting your bolus speed see Bolus Speed on page 64 Max Bolus limits the amount of insulin that can be delivered in a single bolus Your pump prevents single bolus insulin deliveries that exceed the max bolus you set You can set your max bolus from 0 to 75 units Set your max bolus as prescribed by your healthcare professional If you are setting your max bolus after you have set up your Preset Bolus deliveries you cannot set your max bolus lower than any of your Preset Bolus amounts To set your max bolus 1 Go to the Max Basal Bolus screen Menu Insulin Settings Max Basal Bolu
107. e unavailable because the pump is not currently delivering insulin Trend arrows Shows the rate at which the most recent sensor glucose level is rising or falling For more information about trend arrows see Identifying rapid changes in sensor glucose on page 192 Setting up Continuous Glucose Monitoring 155 MP6025957 024 A Note Several items appear on both your Home screen without CGM and your Home screen with CGM For more information see Home screen on page 26 and Status bar on page 28 Understanding glucose settings There are several types of glucose alerts you can set to notify you if your glucose values are changing at a particular rate or if they are approaching or have reached a specified low or high limit You can also set your pump to automatically suspend insulin delivery before or when you reach your low limit The following graph shows the different high and low glucose alerts you can use High Limit Alert on high Alert before high Resume basal alert Sensor Rise Alert 5 a Glucose Suspend before low Alert before low Suspend on low Alert on low Low The high alerts are described in the High settings section on page 156 For details on low alerts and suspend options see Low settings on page 157 High settings These settings alert you if your sensor glucose is rising rapidly Rise Alert is approaching your high limit Alert before high has reached your high limit Alert on high T
108. ect Next 3 Select Square 4 Select Duration and set the amount of time over which you want your Square Wave bolus to be delivered The duration can be from 30 minutes to 8 hours and is set in 15 minute increments 5 Select Deliver Bolus to start your bolus During a Square Wave delivery the Bolus button on your Home screen appears as Bolus S You can select Bolus S to stop the bolus to see details on the insulin that has been delivered or to access the Bolus menu The Bolus menu provides access to the Bolus Wizard Manual Bolus Preset Bolus and Insulin Settings options Dual Wave bolus The Dual Wave bolus feature meets both immediate and extended insulin needs by delivering a combination of an immediate Normal bolus followed by a Square Wave bolus Dual Wave bolus can be useful in these situations When you need to correct elevated blood glucose before a meal and you also need a delayed bolus for food that is absorbed slowly Bolus 9 MP6025957 024 A When you eat meals with mixed nutrients such as carbs fats and proteins that are absorbed at different rates Turning on or off Dual Wave bolus The Dual Wave bolus delivery option is available only after you turn on the Dual Wave feature To turn on or turn off the Dual Wave feature l Go to the Dual Square screen Menu Insulin Settings Dual Square Wave Select Dual Wave to turn the feature on or off Select Save Delivering a Du
109. een highlight and select the status bar at the top of your Home screen Troubleshooting 23 et le a Uu gt je je et le MP6025957 024 A Bolus Basal The Status screen appears Status Jan 1 13 Quick Status Pump 127 UE Settings Review 2 From the Status screen you can select the type of status information you want to view For example to see a quick status of your pump and recent insulin deliveries go to Quick Status For details see Status screens on page 31 My pump is asking me4o enter my settings Certain pump errors can clear your settings and return them to their factory default values This also happens if you intentionally clear your settings Do not clear your settings unless directed to do so by your healthcare professional If you have saved your settings using the Save Settings option you can restore them using the Restore Settings option If you restore your settings ensure the restored settings match the settings prescribed most recently by your healthcare professional The Startup Wizard appears automatically when your pump restarts The wizard guides you through entering the following information Be sure to have these values ready when you begin Time format time and date e Carb unit e Active Insulin Time 232 Chapter 13 MP6025957 024 A e Basal patterns After you enter your pump settings you have the option of entering the following
110. en a condition causes your pump to reset to factory settings You see this alarm after your pump guides you through re entering the Startup Wizard settings The Check Settings alarm is letting you know that other settings may have been cleared or reverted to factory default values Review any settings that you have not already set in Startup Wizard and re enter the values if necessary My pump is asking me to rewind WARNING Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing Never insert the reservoir into the pump while the tubing is connected to your body Doing so could result in an accidental infusion of insulin which may cause low BG You always rewind your pump when changing the reservoir Rewinding returns the piston in the reservoir compartment to its starting position It is normal for your pump to ask you to rewind anytime you must remove and replace the reservoir such as when resolving an Insulin Flow Blocked alarm or addressing a problem loading the reservoir dropped my pump AN Caution If your pump has been dropped or you suspect your pump is damaged carefully inspect your pump to ensure there are no cracks before exposing your pump to water Do the following 1 Check that all connections are still tightly in place 2 Check the display button area and pump case for cracks or damage 3 Check the infusion set including the tubing connector and tu
111. end on low feature Next steps Select OK to clear the alert e Check your BG Follow instructions from your healthcare professional and continue to monitor your BG Select OK to clear the alert e Check your BG Follow instructions from your healthcare professional and continue to monitor your BG Select OK to clear the alert e Check your BG Follow instructions from your healthcare professional and continue to monitor your BG Select OK to clear the alert e Check your BG Follow instructions from your healthcare professional and continue to monitor your BG Alarms alerts and messages 217 s 2 D et di gt 3 M N M un MP6025957 024 A Title and text Basal delivery resumed Maximum 2 hour suspend time reached Check BG Basal delivery resumed Maximum 2 hour suspend time reached SG is still under Low limit Check BG BG not received Place pump close to transmitter Select OK to resend BG to transmitter 218 Chapter 12 Explanation Your pump is resuming basal insulin delivery two hours after a Suspend before low or Suspend on low event occurred Your pump is resuming basal insulin delivery two hours after a Suspend before low or Suspend on low event occurred The transmitter was unable to receive the calibration BG meter readings from the pump Next steps Select OK to clear the alert e Check y
112. ensor and transmitter follow the instructions on the pump screen to troubleshoot the issue as described below If your pump finds the sensor signal at any time during troubleshooting your pump beeps or vibrates and Warm up appears on your sensor graph It can take up to two hours for your sensor to warm up 234 Chapter 13 MP6025957 024 A Note If you are using Alert Silence and currently have all sensor alerts silenced your pump does not display the troubleshooting screens Any glucose alerts you received are displayed in the Alarm History screen 1 Make sure your setup meets the following requirements e Your transmitter is fully charged If both lights on the charger are off your transmitter is fully charged For details see your transmitter user guide e You have only one transmitter connected to your pump Delete the current transmitter that is connected to your pump before continuing For details see Deleting the transmitter from your pump on E le a o N gt O O et tQ page 181 Your transmitter is placed next to your pump Your transmitter is reconnected to the pump if your pump has been recently reset For details see Wirelessly connecting your pump and transmitter using Auto Connect on page 175 e The Airplane Mode is turned off on your pump e You have applied the tape correctly as instructed in the serter user guide 2 Disconnect the transmitter from the sensor
113. er meter When the pump is on the Home screen it beeps or vibrates when it receives a blood glucose reading from the meter Your BG Meter screen appears where you can view your current blood glucose reading and if necessary deliver a bolus Once received your BG values will appear on your pump screen for 12 minutes along with any insulin that is still active from any previous boluses If your blood glucose reading is outside the range of 3 9 to 13 9 mmol L the pump displays an alert In this case treat your low blood glucose or high blood glucose as directed by your healthcare professional Note In order to ensure accuracy do not use a BG meter reading if B more than 12 minutes have passed since you have taken the reading The compatible Bayer meter may not be available in all countries Meter 111 MP6025957 024 A You can also deliver a Normal Bolus or Preset Bolus from your compatible Bayer meter For more information about setting up your pump to use the Remote Bolus feature see Setting up Remote Bolus on page 112 Consult your healthcare professional before using the Remote Bolus feature Wirelessly connecting your pump and meter Always refer to your compatible Bayer meter user guide for instructions on connecting the meter to the pump Setting up Remote Bolus Remote Bolus allows you to send a Normal Bolus or Preset Bolus remotely from your meter To access this option your compatible Bayer meter and pump must
114. er you calibrate thereafter to receive SG values again Guidelines for calibrating Follow these guidelines for best sensor calibration results e Calibrate three to four times spread out throughout the day to improve accuracy For details see When to calibrate on page 186 e You can calibrate anytime However calibrating with two or three trend arrows may temporarily decrease accuracy until the next calibration For an example of trend arrows on the Home screen see Home screen with CGM on un D er em 5 o A 5 er 5 un ES A un M 3 5 zt e page 153 e Always calibrate immediately after testing your BG Never calibrate with a BG meter reading that you have taken more than 12 minutes earlier as that BG value would no longer be considered valid Always use clean dry fingers when you test your blood glucose levels Use only your fingertips when obtaining blood samples for calibration Note If your BG meter readings are significantly different than your sensor glucose readings you need to wash your hands and calibrate again Setting up Continuous Glucose Monitoring 187 MP6025957 024 A Disconnecting the transmitter from the sensor Always refer to your transmitter user guide for instructions on disconnecting the transmitter from the sensor Removing the sensor Always refer to the sensor user guide for instructions on how to remove the sensor T
115. ers along with the specific reminders for BG Check and Medication To create a new Personal reminder dl Go to the Personal screen Menu Reminders Personal Select Add New The Select Name screen appears showing the available reminders Select the reminder that you want to set The Edit screen appears for the selected reminder Enter the time that you want the reminder to occur Select Save The Personal reminder occurs at the specified time each day unless you change or delete it To change rename or delete an existing Personal reminder l Go to the Personal screen Reminders 129 MP6025957 024 A Menu gt Reminders gt Personal 2 Select the reminder that you want to change 3 Do one of the following Select Reminder to turn this reminder on or off Select Edit to change the time of the reminder Select Rename to select a new name for this reminder Select Delete to delete this reminder Bolus BG Check reminder Bolus BG Check reminder helps you remember to check your blood glucose after a bolus After you start a bolus the pump asks you when you want to be reminded to check your blood glucose The timer counts down from the time the bolus started Note The Bolus BG Check reminder is not available when you deliver a bolus using the Remote Bolus feature from your compatible Bayer meter To turn on or turn off Bolus BG Check reminders 1 Go to the BG Check screen Menu Reminders Bolu
116. es steps for problem resolution Next steps Select Yes to allow connection only if you are expecting or performing a data download e Select No to deny connection If no selection is made the screen will timeout after 30 seconds and will automatically reject the request Select OK to clear the alert Wait for the data to finish downloading e If problem still persists or if there is no progress in download call your local representative for assistance MP6025957 024 A MP6025957 024 A Troubleshooting This chapter contains procedures and information to help you understand and address conditions that might occur with your pump et O un gt je je et le For a list of alarms alerts and messages that may appear on your pump see Pump alarms alerts and messages on page 202 Troubleshooting pump issues WARNING If you receive a critical error on your pump the following screen displays and the pump sirens Immediately disconnect from your insulin pump and discontinue use Contact your local representative for assistance Remember your body still needs insulin while your pump is removed It is important that you consult your healthcare professional to determine an alternate method of receiving insulin while your pump is removed Troubleshooting 229 MP6025957 024 A What is a Check Settings alarm This alarm occurs wh
117. eservoir compartment of your pump returns to its starting position This may take several seconds During this process a Rewinding message appears Another message appears to let you know that your pump has finished rewinding and then the New Reservoir screen appears Reservoir and infusion set 95 MP6025957 024 A New Reservoir 1 Fill reservoir 2 Connect tubing to reservoir DO NOT CONNECT TO BODY 3 Follow the instructions in the next section to fill your reservoir Filling the reservoir WARNING Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or inside the tubing connector as shown in the image Liquid can temporarily block the vents This may result in the delivery of too little or too much insulin which can cause hypoglycemia or hyperglycemia If any liquid gets on the top of the reservoir or inside the tubing connector start over with a new reservoir and infusion set Tubing Top of connector reservoir WARNING Always allow your insulin to reach room temperature before use Cold insulin can cause air bubbles in the reservoir and tubing which may result in inaccurate insulin delivery 96 Chapter 5 MP6025957 024 A To fill the reservoir do these steps 1 Remove the reservoir from the package and fully extend the plunger reservoir transfer plunger 2 Swab the vial with alcohol not shown 3 Press the transfer guard onto the vial w
118. ess the A or buttons to view graphs that cover different time periods You can view 3 hour 6 hour 12 hour and 24 hour graphs Sensor Demo simulates a sensor glucose graph showing an example of the general trend of glucose as it rises and falls over time The top of the graph indicates the time of day while the side bar shows the sensor glucose SC reading markers To exit Sensor Demo press To see and hear examples of sensor related alerts la Go to the Sensor Demo screen General settings 147 5 4 t un D e UM MP6025957 024 A Menu gt Utilities gt Sensor Demo 2 Select Alert Demo 3 To see and hear sensor related alerts select any of the listed alerts 4 To exit an alert example press then select OK to clear the alert To exit Sensor Demo press Time and date Make sure the time and date are always set correctly on your pump This is necessary to ensure the correct basal insulin delivery and to keep an accurate record of pump functions You may need to change the time or the date if you travel to a different time zone or practice daylight saving time After the time and date are changed the pump adjusts all settings automatically To change the time and the date 1 Goto the Time amp Date screen Menu Utilities Time amp Date 2 Select and change the Time Time Format or Date as necessary If you are using a 12 hour clock be sure to specify AM
119. et Temp basal rates The Preset Temp feature allows you to set up basal rates for recurring short term situations where you need to temporarily change your basal rate Basal 49 MP6025957 024 A There are four names you can use to match your preset temp basal rate to a situation High Activity Moderate Activity Low Activity and Sick There are also four additional preset temp rates available to use for other circumstances Temp 1 through Temp 4 Setting up and managing Preset Temp basal rates This section describes how to set up edit rename or delete a preset temp basal rate For information on how to start using a preset temp basal rate see Starting a Preset Temp basal rate on page 51 To set up a preset temp basal rate 1 Go to the Preset Temp Setup screen Menu gt Insulin Settings gt Preset Temp Setup 2 Select Add New 3 Select a name for the preset temp basal rate you want to set Temp 1 High Activity Moderate Activity Low Activity or Sick 4 The Type defaults to Percent You can switch between Percent and Rate by selecting Type 5 f you are using Percent enter the percentage you want to use If you are using Rate enter the rate in units per hour You cannot exceed your max basal rate 6 Set the Duration from 30 minutes to 24 hours in 15 minute increments that you want this preset temp basal to be active Select Save To change rename or delete a preset temp basal rate 1 Go to t
120. ettings 2 Simultaneously press and hold gt and until the Manage Settings menu appears 3 Select Settings History The Settings History screen appears Self Test Self Test is a safety utility that allows you to check if your pump is operating properly This self diagnostic feature can be used for maintenance or to check that your pump is operating properly Self Test is additional to the routine tests that run independently while the pump operates General settings 145 2 u D u MP6025957 024 A WARNING Your insulin is suspended for up to two minutes while your pump runs the self test Self Test includes the following tests Test Description Display Turns on the display for up to 30 seconds Notification light Turns on the notification light for three seconds and then turns it off Vibration Generates two vibration cycles Tone Generates an alert tone an Easy Bolus step 1 tone and an alarm tone The pump will run through a series of tests as listed in the previous table Self Test requires you to observe the pump during the test To run the Self Test to the Self Test screen Menu Utilities Self Test A message indicates that the Self Test is in progress Self Test takes up to two minutes to complete During that time the display briefly turns white the notification light blinks the pump vibrates and the pump beeps If Self Test does
121. evious 24 hour period This information is primarily used by support personnel for troubleshooting and is available only after you have turned on the Sensor feature To view your ISIG History 1 Go to the ISIG History screen Menu gt History gt ISIG History 2 Select a time for which yourwant to view the ISIG history The ISIG history appears for the hour you selected Event Markers The Event Markers feature allows you to electronically save certain types of information When using this feature enter events when they happen because the system records the time of the entry You cannot change entries after you have put the information into your pump You can view your saved events in the Daily History screen The entered information can be sent to CareLink Personal therapy management software There it can be used to generate reports you can share with your healthcare professional To enter Event Markers 1 Goto the Event Markers screen Menu Event Markers 124 Chapter 7 MP6025957 024 A 2 Select and enter event information for any of the following categories BG Injection Food Exercise Other 9 e 5 If you are not using the Bolus Wizard or a compatible Bayer meter to record your BG meter readings in your pump you can enter them here If you are using a sensor you may use a BG meter reading you enter here for calibration You can also enter non calibration BG meter readings such as t
122. f D Select Alert before low to receive an alert before you reach your low limit If Suspend before low is also on you are alerted when insulin is suspended Chapter 10 MP6025957 024 A C Select Suspend on low to have insulin suspended when you reach or fall below your low limit The Alert on low alert is automatically turned on and cannot be turned off d Select Alert on low if you want to receive an alert when your SG reaches or falls below your low limit If either suspend feature is on this will already be on e Select Resume basal alert if you want an alert when basal insulin delivery is resumed based on SG values during a suspend by sensor event If you do not turn on the alert the Basal delivery resumed message will still appear on the pump but you will not be alerted 2 Note When setting your low alerts e If you turn on the Suspend before low or the Suspend on low feature then the Alert on low feature is turned on automatically e Only one suspend by sensor feature can be used during each time segment You cannot use both the Suspend before low and the Suspend on low features in the same time segment If you entered an End time of anything other than 00 00 another time segment appears When you are done entering your low settings select Done Review your settings and select Save To make changes to your Low Settings 1 Go to the Low Settings screen Menu gt Sensor Settings gt Low Setting
123. for use with an infusion pump Do not put any other drugs or medications inside your reservoir for use with this pump Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing Never insert the reservoir into the pump while the tubing is connected to your body Doing so could result in an accidental infusion of insulin Do not insert the reservoir in the pump if you did not rewind your pump Doing so could result in an accidental infusion of insulin While the infusion set is connected to your body do not unscrew or retighten the tubing connector on the reservoir 6 Chapter 1 MP6025957 024 A Do not use the MiniLink transmitter MMT 7703 with the MiniMed 640G insulin pump as this device does not communicate with this insulin pump Do not modify this product as modification could result in a safety hazard Do not use your pump if the screen appears broken or unreadable In some instances impact to the pump can damage the screen while the buttons continue to function If the screen is broken or unreadable do not press any buttons Remove the pump and begin using your backup insulin plan per the direction of your healthcare professional If the pump is accidentally programmed while the screen is broken or unreadable this could result in high or low blood glucose levels If your screen is damaged contact the 24 Hour HelpLine or your local representative to arrange for sh
124. for at least 10 seconds 3 Reconnect the transmitter with the sensor to restart communication While the light on the transmitter is blinking select OK on the pump to acknowledge the alert 4 Depending on whether the light blinked when you connected the transmitter to the sensor select Yes or No on your pump and do one of the following Did transmitter light blink when connected to sensor Yes Troubleshooting 235 MP6025957 024 A e If the transmitter light did not blink you need to charge your transmitter When your transmitter is charged start your sensor For details see Starting the sensor on page 182 e If your transmitter light blinked but you still have no sensor signal continue to the next step 5 Move your pump closer to your transmitter and select OK It can take up to 15 minutes for your pump to find the sensor signal 6 If your pump still cannot find the sensor signal make sure you are away from any electronic devices that might cause interference such as cellular phones and other wireless devices and select OK f you have gone through all the troubleshooting steps on your pump screen and your pump still cannot find the sensor signal or if your sensor graph displays Sensor signal not found See User Guide call your local representative for assistance Calibration not accepted Calibration not accepted alert occurs when one of the following happens System was unable to u
125. g your pump and transmitter using Manual Connect on page 179 If your pump found multiple devices B 178 Write down the serial number for your transmitter The serial number can be found on the back of your transmitter Place the transmitter back on the charger and make sure your transmitter is fully charged before continuing Select Next from the Multiple Devices Found message to display the Enter Device SN screen Manually enter your device serial number by following the instructions starting with step 4 in Wirelessly connecting your pump and transmitter using Manual Connect on page 179 Chapter 10 MP6025957 024 A Wirelessly connecting your pump and transmitter using Manual Connect The Manual Connect process requires you to enter the serial number of the transmitter into your pump Use this process if you are unsuccessful using the Auto Connect process or when multiple people in close range are connecting their pumps with other devices such as a group training session 4 Note You can connect only one transmitter to your pump If you already have a transmitter connected to your pump you must delete it before continuing For instructions on deleting a transmitter from your pump see Deleting the transmitter from your pump on page 181 Connecting your pump and transmitter using Manual Connect 1 You need the serial number for your transmitter during the connection process Write down the serial number in the f
126. gs For details on the Low Settings see Low settings on page 157 Note When you enter your settings you first define the time segment and then select the low settings you want on during that time segment To set up the Low Settings 1 Goto the Low Settings screen Menu Sensor Settings Low Settings The Low Settings screen appears Setting up Continuous Glucose Monitoring 171 un M er em o A 5 er 5 un c e un b 5 le e MP6025957 024 A 192 Select Low Settings to turn on the feature The Low Setup screen appears Select the time segment The End time starts flashing The Start time of the first time segment is always 00 00 You can set up to eight time segments each with a different low limit If you set more than one time segment the time segments must cover a 24 hour period Set the End time Set your low limit You can enter a value from 2 8 to 5 0 mmol L in increments of 0 2 mmol L Select the arrow to the right of the End time to select the low settings for this time segment A screen appears showingthe available settings for the selected time period 00 00 24 00 3 4 mmo Alert before low Suspend on low Alert on low Next Set the following as desired a Select Suspend before low to have insulin suspended before you reach your low limit The Alert on low alert is automatically turned on and cannot be turned of
127. hat lets you set the length of time that bolus insulin is tracked as active insulin An attachment that can be used to ensure that the reservoir stays secure during activity or when the pump is worn by a child A feature that temporarily stops your device from communicating wirelessly An audible beep or vibration with a message to inform you that the pump is no longer delivering insulin Alarms require immediate action A feature that stores information about recent alarms and alerts An audible beep or vibration with a message to inform you of a situation that may require your attention An alert that occurs when you are approaching your low sensor glucose value The values that you set to determine when low and high glucose alerts are triggered Glossary 277 E 2 O u u Q lt MP6025957 024 A Alert on low Auto Suspend Awake mode basal insulin basal pattern basal rate BG BG Targets Block Mode blood glucose BG blood glucose meter Bolus BG Check reminder bolus insulin Bolus Speed 278 Glossary An alert that occurs when your sensor glucose value reaches or falls below your low limit An alarm that you set to suspend insulin delivery and trigger an alarm if no buttons are pressed for a specified period of time Clearing the alarm resumes insulin delivery A state in which the pump screen is on Unless you are actively using another screen your Home screen appe
128. he Preset Temp Setup screen Menu Insulin Settings Preset Temp Setup 2 Select the desired preset temp basal J Note You cannot select a preset temp basal rate that is currently in use 3 Select Options and then do one of the following 50 Chapter 3 MP6025957 024 Select Edit to adjust the Type Percent or Rate the Percentage or Rate amount and the Duration for this preset temp basal rate Select Rename to assign a different name to this preset temp basal rate When the Select Name screen appears you can select any available name from the list e Select Delete to delete this preset temp basal rate Starting a Preset Temp basal rate You must set up preset temp basal rates before you can use the Preset Temp feature For more information see Preset Temp basal rates on page 49 To start a preset temp basal rate 1 Goto the Preset Temp screen The Preset Temp option only appears if you have set up preset temp basal rates Home screen Basal Preset Temp The Preset Temp screen displays the preset temp basal rates you have set up along with their percentage or rate amounts Preset Temp 17 08 Current rate 0 025 umr 0 100 unr High Activity 25 Moderate 50 2 Note Depending on your active basal pattern it is possible for a percentage preset temp basal rate to exceed your max basal limit Because you cannot use a preset temp basal rate that exceeds your max basal limit these rates
129. he Square portion of a Dual Wave bolus is being delivered Bolus 73 MP6025957 024 A Delivering a Normal bolus with the Bolus Wizard To deliver a Normal bolus using the Bolus Wizard ls 74 For a correction bolus or a food bolus with a correction use your BG meter to check your blood glucose For a food bolus only skip this step Go to the Bolus Wizard screen Home screen gt Bolus gt Bolus Wizard The Bolus Wizard screen shows your current BG meter reading if applicable and any insulin that is still active from previous boluses For more information about active insulin see About active insulin on page 72 For more information see About your compatible Bayer meter on page 111 Z Note Be aware that if you already have the Bolus Wizard open prior to wirelessly sending your BG meter reading to your pump you must close the Bolus Wizard and open it again in order for that reading to appear Bolus Wizard Active Ins adjust 0 If you are not using a wirelessly connected compatible Bayer meter you can select BG to manually enter your BG meter reading Note If you choose not to enter a BG value three dashes appear on the screen in place of the BG value For a food bolus select Carbs to enter the carb count of your meal For a correction bolus where no food was eaten leave the Carbs value at 0 Your calculated bolus appears in the Bolus field Chapter 4 MP6025957 024 A Bolus Wizard B
130. he Status screen appears Status Jan 1 13 Quick Status Pump TUM fe H Settings Review 3 Select the status screen that you want to view Refer to the table at the beginning of this section for a description of the different status screens Using the Menu screen The Menu screen is where you access the various features and functions of your system To display the Menu screen press l 32 Chapter 2 MP6025957 024 A Menu Audio Options History Reservoir amp Tubing Insulin Settings The following options are available from the Menu screen Select this To do this Suspend Delivery Stop your current basal and bolus insulin delivery Audio Options Set your audio vibrate and volume options for the notifications you receive History Access the Summary Daily History and Alarm History screens If you are using a sensor you can access the SG Review 1516 History screens Reservoir amp Start the process of changing your reservoir and infusion set Tubing Insulin Settings Set up and manage your insulin delivery options including your Basal and Bolus settings Sensor Settings Set up your optional continuous glucose monitoring device settings Event Markers Save information about events such as exercise blood glucose readings carbs you eat or injections you take If you are using a sensor the blood glucose readings may be used for calibration Reminders Set up reminders to help monitor your sy
131. he following table describes the High Settings 156 Chapter 10 MP6025957 024 A High glucose Description setting High limit Your high limit is the value on which your other high settings are based Your high limit can be set from 5 6 mmol L to 22 2 mmol L You can set up to eight high limits for different time segments throughout the day or night Alert before When Alert before high is on you will receive an alert any time the high sensor glucose is predicted to reach the high limit This makes you aware of potential highs before they occur Time before Time before high is only available when using Alert before high Time high before high determines when you will receive an Alert before high You can set a time between 5 and 30 minutes Alert on high When Alert on high is on your system alerts you when your SG reading reaches or exceeds your High Limit Rise Alert The Rise Alert notifies you when your glucose is rising rapidly This alert helps you understand how much your glucose levels are affected by meals or for example when forgetting to give a bolus Rise Limit The Rise Limit determines when you will receive a Rise Alert Rise Limit is only available when using Rise Alert un D er em 5 o A 5 er 5 un ES A un M 3 5 zt e To set up your high settings see Setting up the High Settings on page 167 Low settings The low settings allow you to be alerted a
132. he icon indicate the status When you insert a new sensor the icon is solid green As your sensor life is used the icon becomes emptier The icon turns yellow when less than 24 hours remains in the life of your sensor It turns red when less than 12 hours remains in the life of your sensor rom 6 rom rom ma io om 6 If the number of days remaining in the life of your sensor is 6 unavailable the Sensor Life icon appears with a question mark b 5G reading Shows your current SG reading which is sent wirelessly to your pump by the transmitter SmartGuard The SmartGuard suspend by sensor icon appears only when either the suspend by Suspend before low or Suspend on low feature is set to on For details sensor icon on the SmartGuard feature see SmartGuard on page 152 The SmartGuard suspend by sensor icon indicates the current status of the suspend features as follows N M er e j A 5 er 5 O un ES e un M 3 er 5 The icon is solid gold Q when either the Suspend on low or Suspend before low is turned on and ready e The gold icon flashes if your insulin delivery is currently suspended due to a Suspend on low or Suspend before low event The icon appears gray with a line through it when neither suspend feature is available The suspend features might be unavailable due to a recent suspend or because there are no SG values available It might also b
133. hose readings taken when eating or when your BG is rising or falling rapidly Enter the number of units of any insulin you have given by injection Note Insulin units entered using the injection event marker are not added to your Active Insulin amount tracked on the pump Enter the amount of carbohydrates that you have eaten or drunk that have not been entered in the Bolus Wizard For example you might enter carbs that you ate to correct a low BG Do notventer carbs here that you have already entered in the Bolus Wizard Enter the length of time you exercised It is helpful to be consistent and enter the information either before or after each time you exercise Examples of Other event markers can include when you take medications when you feel ill or when you are under stress History and events 125 F N et O lt 5 o b lt 5 et N MP6025957 024 A 126 Chapter 7 SEITEN MP6025957 024 A MP6025957 024 A Reminders Reminders help you remember to do important routine activities There are specific reminders that prompt you to check your BG after a bolus give a food bolus check your reservoir level and change your infusion set There are also personal reminders you can use for any purpose If you have the sensor feature turned on the calibration reminder prompts you to calibrate your sensor Personal reminders The Personal reminders include six numbered remind
134. ic Diabetes The pump has undergone extensive testing to confirm appropriate operation when used with compatible reservoirs and infusion sets manufactured or distributed by Medtronic Diabetes We cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third parties and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use Before you begin 13 o lt G MP6025957 024 A Reservoirs Use only Medtronic reservoirs For the MMT 1511 pump model use the MMT 326A 1 8 ml 180 unit reservoir Look on the back of your pump for your model number For the MMT 1711 pump model use either the MMT 332A 3 0 ml 300 unit reservoir or the MMT 326A 1 8 ml 180 unit reservoir depending on your insulin needs Infusion sets Medtronic Diabetes provides a variety of infusion sets to fit your needs Contact your healthcare professional for help in choosing an infusion set Change your infusion set every two to three days per your infusion set manufacturer s instructions Optional devices Compatible Bayer blood glucose meter 640G system comes with a compatible Bayer blood glucose meter It wirelessly connects to your pump allowing you to send BG meter readings to your pump The Remote Bolus feature allows you to use your meter to start a bolus on your pump You can also
135. ies you of a potential hazard which if not avoided may result in minor or moderate injury or damage to the equipment A WARNING A warning notifies you of a potential hazard which if not avoided could result in death or serious injury It may also describe potential serious adverse reactions and safety hazards Keep an emergency kit with you at all times to make sure that you always have necessary supplies Tell a family member co worker or friend where you keep your emergency kit It is important that you test your blood glucose BG more frequently while you are traveling The routine hassle of travel including stress changes in time zones schedules and activity levels meal times and types of food can all affect your diabetes control Be extra attentive to monitoring your BG frequently and be prepared to respond if needed Your emergency kit should include these items Fast acting glucose tablets Blood glucose monitoring supplies Urine or blood ketone monitoring supplies Extra MiniMed compatible infusion set and MiniMed reservoir Extra new AA lithium or alkaline batteries or fully charged NiMH batteries 4 Chapter 1 MP6025957 024 A Insulin syringe and fast acting insulin with dosage instructions from your healthcare professional Wallet card packaged with your pump accessories Adhesive dressing Glucagon emergency kit WARNING Do not use the Bolus Wizard to calculate a bolus for
136. ight sensor with your finger while using your pump Covering the light sensor may adjust the brightness on the screen when brightness is set to Auto See Display Options on page 141 for more information 20 Chapter 2 MP6025957 024 A The following table describes how to use the buttons To do this Scroll up or down a menu or list or increase or decrease the value of a setting Select an item on a screen or Menu Enter a value into a field Return to the previous screen Display the Menu screen Display the Home screen Put the pump in sleep mode Wake up the pump About batteries Follow these steps Press the A or V buttons Press the A v or gt buttons to select the desired item and then press the O button Press the A v or gt buttons to select the desired field and then press the O button The field you select flashes Press the A or v buttons to enter the desired value and then press the O button Press the button Press the amp button When you are on any screen other than the Home screen press and hold the a button for about one second Press and hold amp for about two seconds Press any button The pump requires one new AA 1 5 V battery For best results use a new AA lithium FR6 battery The pump also accepts an AA alkaline LR6 or a fully charged AA NiMH HR6 nickel metal hydride rechargeable battery Caution Do not use a carbon zinc ba
137. ignal from the sensor another message appears to let you know Select OK to clear the alert e Change your sensor For details see your sensor user guide e After you change your sensor refer to Starting the sensor on page 182 Select OK to clear the alert e Change your sensor For details see your sensor user guide Select OK to clear the alert e Change your sensor For details see your sensor user guide MP6025957 024 A Title and text Check connection Ensure transmitter and sensor connection is secure then select OK Lost sensor signal Move Pump closer to transmitter May take 15 minutes to find signal Low battery transmitter Recharge transmitter within 24 hours Medical device CALL FOR EMERGENCY ASSISTANCE have diabetes Explanation The pump fails to detect the transmitter and is unable to receive sensor signal Transmitter signal has not been received for 30 minutes during or after initialization The battery in the transmitter needs to be recharged within 24 hours Your pump is suspended due to low SG and you have not responded to the alarm within 10 minutes Next steps Select OK to clear the alert e If your sensor is fully inserted select Yes If your sensor is not fully inserted select No e If your sensor was not fully inserted insert a new sensor If you still cannot connect your sensor see My pu
138. ing devices such as in a training class use the Manual Connect process on page 179 Connecting your pump and transmitter using Auto Connect 1 Attach your transmitter to the charger and make sure the transmitter is fully charged Keep your transmitter attached to the charger Setting up Continuous Glucose Monitoring 175 MP6025957 024 A i 176 charger transmitter Note Both lights on the charger are off when the transmitter is fully charged For more information see your transmitter user guide Go to the Auto Connect screen Menu gt Utilities gt Device Options gt Connect Device gt Auto Connect Auto Connect Before using uto Connect be sure no other nearby Medtronic devices are in search mode v Make sure there are no other devices in search mode nearby scroll down to the bottom of the Auto Connect screen and select Continue Auto Connect are in search mode Cancel The New Device screen appears Place the transmitter still attached to the charger next to the pump Chapter 10 MP6025957 024 A Select Search on your pump and immediately remove the transmitter from the charger New Device See User Guide to connect new device Select Search below when ready The following happens when you start the search process On your pump a message appears to let you know your pump is searching e On your transmitter a green light flashes briefly and then tu
139. ing you know that your settings are complete Select OK to continue using your pump Troubleshooting 233 MP6025957 024 A To enter your Bolus Wizard settings 1 When your pump shows a list of settings for the Bolus Wizard make sure you have the values you need before continuing Depending on the Carb Unit you set earlier either the Carb Ratio or the Exch Ratio screen appears Enter your carb ratio or exchange ratio by entering the End time and the Rate You can adjust your carb or exchange ratio at any time For details see Changing your carb or exchange ratio on page 69 When the Edit Sensitivity screen appears enter your insulin sensitivity factor by entering the End time and the mmol L per unit You can adjust your insulin sensitivity factor at any time For details about entering insulin sensitivity factors including how to set multiple time periods see Changing your insulin sensitivity factor on page 70 When the BG Target screen appears enter your BG Target range by entering the End time and your Lo low and Hi high limits You can adjust your BG Target ranges at any time For details see Changing your Bolus Wizard BG target on page 70 A message appears confirming that your setup is complete Select Next to display the Home screen and continue using your pump Troubleshooting sensor issues My pump cannot find the sensor signal If your pump cannot find the sensor signal after you connect your s
140. insulin delivery resumes the SmartGuard suspend by sensor features will be unavailable for an additional 10 minutes Setting up Continuous Glucose Monitoring 163 un M er em O o A 3 er 5 un c e un b 5 le e MP6025957 024 A If you respond 30 minutes to four hours after your basal insulin delivery resumes the SmartGuard suspend by sensor features will be available immediately If you do not respond the SmartGuard suspend by sensor features will be unavailable for four hours after basal delivery resumes Alert on low The Alert on low feature is automatically turned on when either the Suspend before low feature or the Suspend on low feature is turned on When Alert on low is set to on you receive an alert when your SG reading reaches or falls below your low limit If your pump is suspended and you have not responded an emergency message appears Automatically resuming basal delivery after a SmartGuard suspend by sensor event In addition to suspending insulin delivery the pump can also automatically resume delivery of basal insulin If insulin has been suspended by either the Suspend before low or the Suspend on low feature insulin delivery will automatically be resumed if either of the following conditions are met e if insulin has been suspended for a minimum of 30 minutes and SG values are at least 1 1 mmol L above the low limit and expected to be more tha
141. insulin you receive per hour throughout the day and night Allows you to vary your basal rate according to your needs You can set up to eight basal patterns For details on setting up basal patterns see Adding a new basal pattern on page 42 For details about starting a basal pattern see Changing from one basal pattern to another on page 46 Allows you to temporarily change your current basal rate for a duration of time that you specify For details about starting a temp basal rate see Starting a Temp Basal rate on page 48 Allows you to set and save temporary basal rates for known short term situations such as when you are sick or have times of increased or decreased activity For details about setting up a preset temp basal rate see Preset Temp basal rates on page 49 For details about starting a preset temp basal rate see Starting a Preset Temp basal rate on page 51 Provides a safety measure by limiting the total amount of basal insulin your pump can deliver per hour For details about setting your Max Basal rate see Max Basal Rate on page 41 MP6025957 024 A Max Basal Rate Max Basal Rate limits the amount of basal insulin that can be delivered per hour based on the maximum rate you set You are unable to set any basal rates temp basal rates or preset temp basal rates that exceed the max basal rate amount You can set your max basal rate from 0 to 35 units per hour Set your max basal rate as prescribed b
142. ipment of a replacement pump Exposure to magnetic fields and radiation WARNING Keep the pump away from magnetic fields and avoid direct contact with any magnets If you are going to have an X ray MRI diathermy treatment CT scan or other type of exposure to radiation take off your pump sensor transmitter and meter before entering a room containing any equipment of this kind The magnetic fields and radiation in the immediate vicinity of this equipment can make your devices nonfunctional or damage the part of the pump that regulates insulin delivery possibly resulting in over delivery and severe hypoglycemia Do not expose your pump to a permanent magnet such as pump cases that have a magnetic clasp Exposure to a permanent magnet may interfere with the motor inside the pump Reservoir and infusion sets Only use reservoir and infusion sets manufactured by Medtronic Diabetes The pump has undergone extensive testing to confirm appropriate operation when used with compatible reservoirs and infusion sets manufactured or distributed by Medtronic Diabetes We cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third parties We are not responsible for any injury or malfunctioning of the pump that may occur in association with such use Before you begin 7 O 1 M lt O c e MP6025957 024 A Only use U100 insulin that has been prescribed by your hea
143. is turned on The color and the fill level of the icon indicate the status When your sensor is fully calibrated the icon is solid green As the time for your next sensor calibration approaches the icon becomes emptier and the color of the icon changes as shown in the following example For more information about calibrating your sensor see Calibrating your sensor on page 184 0006460 When your sensor is initializing the Calibration icon appears with three dots If the time to your next sensor calibration is unavailable the Calibration icon appears with a question mark The connection icon appears green QD when the Sensor feature is on and your transmitter is successfully communicating with your pump The connection icon appears gray 63 when the Sensor feature is turned on but the transmitter is not connected or communication with your pump has been lost For more information about the Sensor feature see Understanding Continuous Glucose Monitoring CGM on page 151 Displays your SG readings over a period of 3 hours The red lines represent your high and low SG limits The blue line represents your SG trends during the specified period For more information see The sensor graph on page 191 154 Chapter 10 MP6025957 024 A Item Description Sensor Life The number of days remaining in the life of your sensor The sensor icon life icon appears only when the Sensor feature is turned on The color and the fill level of t
144. ithout pushing down on the plunger D un M 3 lt ar 5 5 h N M er vial 4 Push down on the plunger to pressurize the vial Hold down the plunger rod 5 While still holding down the plunger rod flip the vial over so the vial is on top Slowly pull down on the plunger to fill the reservoir 6 Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir Y Reservoir and infusion set 97 MP6025957 024 A Slowly push up on the plunger just enough to remove any air bubbles from the reservoir Slowly pull down on the plunger to fill the reservoir to the number of units desired To avoid getting liquid on the top of the reservoir flip the vial over so that it is upright Turn the reservoir counter clockwise then pull straight up to remove the reservoir from the transfer guard Place the tubing connector onto the reservoir Turn the connector clockwise pressing gently against the reservoir until you feel it slide in Push in and continue turning until the reservoir and the connector lock with a click Tap the side of the reservoir to remove any air bubbles To purge air bubbles that have risen to the top of the reservoir push up on the plunger until you see insulin in the tubing Without pulling turn the plunger counter clockwise to remove it from the reservoir 14 Select Next from the New Reservoir screen 98
145. ivered and the original bolus amount you set up 90 Chapter 4 reservoir and infusion set MP6025957 024 A MP6025957 024 A Reservoir and infusion set Setting up the reservoir and infusion set When you are ready to use your pump with insulin make sure the time and date are correct on your pump For details on changing the time and date on your pump see Time and date on page 148 You must also program your settings as instructed by your healthcare professional You will need these items MiniMed 640G insulin pump Vial of insulin U100 MiniMed reservoir MiniMed compatible infusion set and its user guide WARNING If this is the first time you are using your pump with insulin and you have practiced giving boluses on your pump you need to clear the active insulin value before starting on insulin For details see Clearing your active insulin on page 144 Removing the reservoir If this is the first time you are inserting a reservoir into your pump and you do not currently have a reservoir loaded skip to Rewinding your pump on page 94 Reservoir and infusion set 93 D un M 4 lt 5 5 h v o N M et MP6025957 024 A WARNING Make sure the infusion set is disconnected from your body before you remove the reservoir from your pump To remove your reservoir 1 Wash your hands 2 Remove the entire infusion set from your body 3 f you have the optional activity guar
146. izard feature Get your prescribed settings from your healthcare professional and always consult your healthcare professional before changing your settings The setup procedure begins on page 66 Bolus 65 MP6025957 024 A Setting Carb Ratio Exchange Ratio Insulin Sensitivity Factor BG Target Active Insulin Time What it does Used for food bolus calculations e If you count carbs the number of carb grams that are covered by 1 unit of insulin e If you count exchanges the number of insulin units that are needed to cover 1 carb exchange Used to calculate correction bolus amounts Your insulin sensitivity factor is the amount that blood glucose is reduced by one unit of insulin The Bolus Wizard calculates your estimated bolus based on your BG target range The high and low values you set are the values to which your blood glucose is corrected To use a single target value rather than a range set the same value for High and Low If your BG value is above the high target value a correction dose is calculated If your BG value is below the low target value a negative correction is calculated and subtracted from your food bolus Active insulin is the bolus insulin that has been delivered by the pump and is still working to lower your blood glucose levels Active insulin time is the length of time that bolus insulin is tracked as active insulin Work with your healthcare professional to get the active insu
147. l pattern to a new basal pattern When the Select Name screen appears you can select any available name from the list Use the Edit option to adjust the new basal pattern as desired Select Delete to delete the selected basal pattern You cannot delete the active basal pattern Changing from one basal pattern to another When you change to a new basal pattern your pump delivers your basal insulin according to the basal pattern you selected To change to a different basal pattern 46 Go to the Basal Patterns screen Home screen Basal Basal Patterns The Basal Patterns screen shows the basal patterns you have set up The active basal pattern is indicated with a check mark Select the basal pattern you want to start The Basal screen displays the details for the selected basal pattern To start this pattern select Begin Chapter 3 MP6025957 024 A Temporary basal rates The Temp Basal feature and Preset Temp feature allow you to set temporary basal rates to manage blood glucose levels during short term activities or conditions that require a basal rate different than your current one such as an illness or a change in physical activity You can make an immediate change to your basal insulin for a set period of time 30 minutes to 24 hours up to your max basal rate About Temp Basal rates A temp basal rate temporarily overrides all other basal programming Your programmed basal pattern resumes after the
148. lect Save Changing your insulin sensitivity factor The Insulin Sensitivity Factor option is only available if the Bolus Wizard feature is turned on To change your insulin sensitivity factor 1 4 Go to the Sensitivity screen Menu Insulin Settings Bolus Wizard Setup Insulin Sensitivity Factor Select Edit Select the sensitivity factor to adjust the Start time the End time and the Sensitivity amount You can set up to eight different sensitivity amounts using different time segments The time segments must cover a 24 hour period If you set a value that is outside the typical range of 1 1 to 5 6 mmol L per unit a message appears asking you to confirm your setting When you have made your changes select Save Changing your Bolus Wizard BG target Your target range can be from 3 3 to 13 9 mmol L The Bolus Wizard BG Target option is only available if the Bolus Wizard feature is turned on 70 Chapter 4 MP6025957 024 A To change your Bolus Wizard BG target range 1 Goto the BG Target screen Menu Insulin Settings Bolus Wizard Setup BG Target 2 Select Edit 3 Select the BG target to adjust the Start time the End time and the Lo low and Hi high BG Target values Your high value cannot be less than your low value You can set up to eight different values using different time segments The time segments must cover a 24 hour period If your BG target is outside the typical range of 5
149. lerted if she reaches her low limit Example 3 Suspend before low responsive stays suspended Doug has just finished his evening jog on the beach As he is walking home he receives a Suspend before low alert He sees that his pump has automatically suspended his insulin delivery Doug clears the alert by selecting OK on his pump He knows that his pump is now suspended and insulin delivery has been stopped He checks his BG to confirm and keeps his insulin suspended A while later Doug receives another alert He looks at his pump and sees that he has received an Alert on low His SG has reached his low limit He clears the alert and checks his BG to confirm He eats carbohydrates to treat the low glucose as instructed by his healthcare professional Doug keeps his insulin suspended as directed by his healthcare professional He knows that once his SG is above his low limit and trending upward or reaches the maximum suspend time of two hours basal insulin delivery will automatically resume Example 4 Suspend on low response after basal delivery resumes Michael is on his college hockey team He played in a hockey tournament all day and is so exhausted that he falls asleep watching television His sensor glucose value begins to drop When his sensor glucose value reaches his low limit the pump begins to alarm It automatically suspends all insulin delivery Michael does not respond to the alarm After ten minutes his pump begins to si
150. lin see About active insulin on page 72 2 Select Bolus to set your bolus delivery amount in units Select Deliver Bolus to start your bolus Your pump beeps or vibrates and displays a message when your bolus starts The Home screen shows your bolus amount as it is being delivered Your pump beeps or vibrates when your bolus is complete Square Wave bolus A Square Wave bolus delivers a bolus evenly over a period of time 30 minutes to 8 hours When using the Bolus Wizard a Square Wave bolus is available only when giving a food bolus without a correction for an elevated BG A Square Wave bolus is not available for a correction bolus alone or a correction bolus with food bolus A Square Wave bolus can be useful in these situations If you have delayed food digestion due to gastroparesis or meals high in fat e When you are snacking over an extended period of time e Normal bolus drops your blood glucose too rapidly 6 Chapter 4 MP6025957 024 A Since the Square Wave bolus extends delivery over a period of time the insulin is more likely to be available as you need it Note You cannot perform these functions during a Square Wave bolus delivery Change the Max Bolus or the Active Insulin Time settings Turn off or deliver Dual Wave or Square Wave boluses Turn the Bolus Wizard feature on or off Fill the cannula Rewind your pump Run a self test Access the Manage Settings menu All other functions
151. lin time that best represents the insulin type you use and your physiological insulin absorption rate For more information about how the Bolus Wizard uses your active insulin amount see About active insulin on page 72 Setting up the Bolus Wizard feature Before you can use the Bolus Wizard to calculate a bolus you must turn on this feature and enter your Bolus Wizard settings 66 Chapter 4 MP6025957 024 A To set up the Bolus Wizard feature l Go to the Bolus Wizard Setup screen Menu Insulin Settings Bolus Wizard Setup The Bolus Wizard Setup screen appears with the Bolus Wizard turned off Bolus Wizard Setup Active Insulin Time Select Bolus Wizard to turn on the feature If this is the first time you have turned on the Bolus Wizard feature your pump displays information about the settings you need to enter Bolus VVizard The following values are needed for Bolus Wizard setup Carb Ratio Insulin Sensitivity BG Target Active Insulin Make sure you have the values you need and then select Next to continue Note As you enter your personal settings your pump displays information about each setting Click Next to continue when you have read each explanation When the Edit Carb Ratio screen appears enter your carb ratio If you are setting a carb ratio set the grams per unit g U If you are setting an exchange ratio set the units per exchange U exch You can set up to eight carb
152. livery being resumed the SmartGuard suspend by sensor features will be unavailable for a total of 30 minutes For example e f you respond 10 minutes after your basal insulin delivery resumes the SmartGuard suspend by sensor features will be unavailable for an additional 20 minutes e If you respond 20 minutes after your basal insulin delivery resumes the SmartGuard suspend by sensor features will be unavailable for an additional 10 minutes If you respond 30 minutes to four hours after your basal insulin delivery resumes the SmartGuard suspend by sensor features will be available immediately If you do not respond the SmartGuard suspend by sensor features will be unavailable for four hours after basal delivery resumes Alert before low When Alert before low is on you will receive an alert when you are approaching your low limit This makes you aware of potential lows before they occur The Alert before low feature can be used with the Suspend before low and Suspend on low features The Alert before low feature works as follows e if Alert before lows on both suspend by sensor features are off you receive the Alert before low 30 minutes before you reach your low limit If Suspend on low is on and Alert before low is on you receive an Alert before low 30 minutes before you reach your low limit If Suspend before low is on and Alert before low is on you receive a Suspend before low alert when insulin delivery is
153. low limit How SmartGuard automatically resumes your basal Automatically resuming basal insulin delivery after a suspend by sensor event delivery after a SmartGuard suspend by sensor event on page 164 To set up SmartGuard suspend by sensor settings see Setting up the Low Settings on page 171 152 Chapter 10 MP6025957 024 A Home screen with CGM When you turn on the Sensor feature the Home screen on your pump changes to display a real time graph that shows your sensor glucose SG information For more information see Turning on the Sensor feature on page 167 sensor status icons trend arrows sensor graph SG reading SmartGuard suspend by sensor icon The following items appear on your Home screen with CGM Item Description Airplane The Airplane Mode icon x appears in place of the Connection icon Mode icon if Airplane Mode is turned on When Airplane Mode is turned on the pump cannot receive wireless communication from other devices For more information about using Airplane Mode see Airplane Mode on un M er 5 o A 3 er 5 un c e un b 5 le e pagi J Setting up Continuous Glucose Monitoring 153 MP6025957 024 A Item Calibration icon Connection icon Sensor graph Description The approximate time left until your next sensor calibration is due The calibration icon appears only when the Sensor feature
154. lthcare professional for use with an infusion pump Do not put any other drugs or medications inside your reservoir for use with this pump For additional warnings related to the reservoir and infusion set refer to the user guides provided with those devices Sensor While there is no evidence of an Enlite sensor breaking in a patient s body if you suspect that sensor breakage has occurred do not attempt to remove the sensor yourself Contact your healthcare professional for assistance in removing the sensor For warnings related to the sensor refer to the user guide provided with that device Transmitter Keep the transmitter away from children This product contains small parts and may pose a choking hazard For warnings related to the transmitter refer to the user guide provided with that device Meter For warnings related to compatible Bayer meters refer to the user guide provided with that device General precautions Although the pump has multiple safety alarms it cannot notify you if the infusion set is leaking or the insulin has lost its potency It is essential that you test your blood glucose levels at least four times per day If your blood glucose is out of range check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered Waterproof capabilities At the time of manufacture and when the reservoir and tubing are properly inserted your pump is waterproof It is
155. lus you want to set The Edit screen for that particular Preset Bolus appears 4 Select Bolus to set the bolus amount 5 Select Type to set this as a Normal bolus Square Wave bolus or Dual Wave bolus 86 Chapter 4 MP6025957 024 A Note Ihe Type field appears only when you have the Dual Wave bolus or Square Wave bolus features turned on If you set the type to Square Wave or Dual Wave additional settings appear 6 df you are setting up a Square Wave bolus or Dual Wave bolus do the following For a Square Wave bolus set the Duration of time for the bolus delivery For a Dual Wave bolus adjust the Now Square percentages as needed then set the Duration of time for the Square Wave portion of the bolus Note If you later turn off the Dual Wave or Square Wave feature your existing Preset Bolus settings are still available for use Select Save Changing renaming or deleting a Preset Bolus You cannot delete rename or edit a Preset Bolus while it is delivering Z Note You cannot edit a Dual Wave or Square Wave Preset Bolus when the Dual Wave or Square Wave features are turned off You can however rename or delete a Dual Wave or Square Wave Preset Bolus when the features are turned off To change rename or delete a Preset Bolus 1 Go to the Preset Bolus Setup screen Menu Insulin Settings Preset Bolus Setup The Preset Bolus Setup screen appears showing any existing Preset Bolus settings 2
156. m after ten minutes the alarm tone escalates to a loud emergency siren For more information see Alarm and alert escalation on page 247 Alerts An alert makes you aware of a situation that may Low battery require your attention An alert is less serious than Pump an alarm 00 00 When an alert occurs Replace battery soon Display The pump displays a notification with a yellow icon and instructions Notification light The red notification light on your pump blinks once followed by a pause then blinks once again in a continuous repeating pattern The notification light is shown in Using the buttons on page 20 Audio Depending on your Audio Options settings the pump either beeps or vibrates in a continuous three pulse and pause pattern or does both To clear an alert press v and then make a selection If you do not respond to an alert the pump beeps every five minutes or every fifteen minutes depending on the alert Some alerts will also escalate to a loud emergency siren after ten minutes For more information see Alarm and alert escalation on page 247 Alarms alerts and messages 201 0 3 D et 0 Q Uu un tp le un MP6025957 024 A Note If an alert occurs when you are in a screen other than the Home screen the alert message may appear after you return to the Home screen Messages A message informs you about the status of your pump or if you need to make a
157. m of notifications Notifications include alarms alerts and messages 7 Note When you receive a notification while your pump is locked you will be able to clear the alarm alert or message without having to unlock your pump After you clear the notification you will be redirected to the Home screen You must unlock your pump before navigating away from the Home screen For more information see Unlocking your pump on page 26 When you have received more than one notification and there are multiple messages to view a small white flap appears on the notification icon in the upper right corner of the screen E When you clear the first notification the next notification becomes visible Note It is important that you promptly respond to all notifications and confirmations that appear on your pump In the event that you do not respond your pump may remain on that screen until addressed Alarms alerts and messages 199 EY s 2 D et di gt 3 D N M MP6025957 024 A When you respond to a message there may be times when another message appears Always be sure to address all notifications you have received A white triangle in the lower right corner means you must press to continue WARNING If you receive a critical error on your pump the following screen displays and the pump sirens Immediately disconnect from your insulin pump and discontinue use Contact yo
158. m your pump clear any active alarms or alerts 2 Use the belt clip to loosen and remove the battery J Note Use your belt Clip to remove and retighten the battery cap If the belt clip is unavailable you may use a coin 3 Remove the battery 4 Dispose of old batteries according to local disposal requirements 5 After removing your battery wait until the Insert Battery screen appears before inserting a new battery First steps 23 MP6025957 024 A If you are removing the battery to place your pump in storage see Storing your pump on page 242 for more information Getting to know your pump This section shows you how to navigate through the screens and menus on your pump It also helps you learn how to enter information and view the status of your pump Entering your startup settings Your pump has a Startup Wizard that begins when you insert your battery for the first time The Startup Wizard guides you through setting the language the time format the current time and the current date Z Note Use this procedure when you are entering your settings for the first time If this is not the first time you are entering your pump settings and your pump is asking you to re enter your settings see My pump is asking me to enter my settings on page 232 To use the Startup Wizard 1 The Startup Wizard begins after the Welcome screen appears When the Language screen appears select your language La
159. me of this reminder Reminders 131 MP6025957 024 A Select Delete to delete this reminder Low Reservoir reminder The Low Reservoir reminder alerts you when the insulin level in your reservoir is low This feature allows you to program your pump to generate a reminder before your reservoir is empty You can select one of the following types of Low Reservoir reminders Units alerts you when your reservoir has a specified number of units remaining and then alerts you again when half of remaining units are used Time alerts you when there is a specified amount of time remaining before your reservoir is empty and then again one hour before insulin runs out depending on your programmed basal insulin delivery Note Ihe amount of time or units remaining in your reservoir can be found on the Quick Status screen For more information on accessing the Status Screens see Viewing the Status screens on page 32 If you use Time for your Low Reservoir reminder be aware that the reminder time is based only on your basal insulin delivery rate If you give a bolus the time remaining will decrease more quickly For example if your reservoir has 10 hours remaining when you go to bed at night and you sleep for eight hours without giving any bolus insulin you will still have two hours of basal insulin remaining when you wake up In contrast suppose your reservoir has 10 hours remaining when you leave the house for work in the mo
160. med alert When Suspend before low is unavailable After a Suspend before low event occurs there is a period of time when the Suspend before low functionality is unavailable This time will vary depending on whether or not you respond to the Suspend before low event You can manually suspend your insulin delivery at any time For details see Stopping and resuming your insulin delivery on page 54 Note The maximum amount of time the Suspend before low feature will be unavailable is four hours When the SmartGuard suspend by sensor features are unavailable the SmartGuard suspend by sensor icon on the Home screen appears gray A When a Suspend before low event occurs and you respond within two hours and Stay suspended for the two hour maximum suspend time the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes Your insulin automatically resumes due to your rising SG levels the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes Manually resume your basal insulin delivery the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes If your pump has been suspended for two hours and you have not responded basal insulin delivery automatically resumes 160 Chapter 10 MP6025957 024 A If you respond within 30 minutes of basal insulin de
161. monitor your BG Alert before low Your SG value is Select OK to clear the alert Sensor glucose approaching your Check your BG specified low limit approaching Low Limit Follow instructions from your Check BG healthcare professional and continue to monitor your BG Alert on high XX X Your SG value is at e Select OK to clear the alert mmol L or above your Check your BG High sensor glucose Follow instructions from your Check BG healthcare professional and continue to monitor your BG 216 Chapter 12 MP6025957 024 A Title and text Alert on low XX X mmol L Low sensor glucose Check BG Alert on low XX X mmol L Low sensor glucose Insulin delivery suspended since XX XX Check BG Basal delivery resumed Basal delivery resumed at XX XX after suspend by sensor Check BG Basal delivery resumed Low settings change caused basal to be resumed at XX XX Check BG Explanation Your SG value is at or below your specified low limit Your SG value is at or below your specified low limit and the pump has suspended insulin delivery due to a Suspend on low or Suspend before low event Your pump is resuming basal insulin delivery after a Suspend on low or Suspend before low event occurred Your pump is resuming basal insulin delivery after a Suspend before low or a Suspend on low event occurred because you have turned off the Suspend before low or the Susp
162. mp and the front of the belt clip Skins also provide additional protection against surface scratches noA 8 Ordering supplies and accessories To order supplies or accessories contact your local representative Before you begin 15 MP6025957 024 A 16 Chapter 1 MP6025957 024 A sd34s 1511 MP6025957 024 A MP6025957 024 A First steps This chapter gives you an overview of your pump so you can become familiar with the buttons and screens Read this entire chapter to understand the basic features and initial setup before using your pump to deliver insulin Your pump The following illustration shows the different parts of your pump The reservoir with the tubing connector attached is inserted into the reservoir compartment tubing connector battery compartment reservoir compartment screen buttons First steps 19 MP6025957 024 A Using the buttons AN Caution Do not use sharp objects to press the buttons on your pump Using sharp objects can damage your pump The following picture shows the buttons the notification light and the light sensor on your pump The notification light flashes when your pump has an alarm or alert The notification light is not visible unless flashing The keypad has a backlight that lights up the buttons when in use notification light left down light sensor menu select right Z Note Do not cover the l
163. mp cannot find the sensor signal on page 234 Move your pump closer to your transmitter It can take up to 15 minutes for your pump to start communicating with your transmitter Select OK to clear the alert Select OK to clear the alert e Recharge your transmitter as soon as possible Select Dismiss e Immediately call for emergency assistance Alarms alerts and messages 221 EY s 2 D et di gt 3 M N M un MP6025957 024 A Title and text No calibration occurred Confirm sensor signal Calibrate by No calibration occurred Confirm sensor signal Check BG again to calibrate sensor Possible signal interference Move away from electronic devices May take 15 minutes to find signal 222 Chapter 12 Explanation The transmitter was Unable to receive the calibration BG meter readings from the pump The transmitter was unable to receive the required calibration BG from the pump Calibration is required by the system for SG values to resume Calibration required appears on your sensor graph There may be interference from another electronic device that is affecting the communication between your pump and transmitter Next steps Select OK to clear the alert e Check the status bar on your pump to ensure that your pump has a signal from your sensor If there is no sensor signal see My pump
164. n Take action based on the selected alert If you have connected a new sensor select Start New Sensor If you have reconnected a sensor you have been using select Reconnect Sensor e In either case a warm up messages appears on your Home screen and you are prompted to calibrate your sensor Your pump Starts receiving your SG values again after the two hour initialization is complete Select Start New Sensor For more information see Starting the sensor on page 182 Alarms alerts and messages 223 EY s 2 D et di gt 3 M N M un MP6025957 024 A Title and text Sensor expired Insert new sensor Sensor signal not found Did transmitter light blink when connected to sensor Sensor signal not found See User Guide 224 Chapter 12 Explanation The sensor has been used for 6 days 144 hours It has reached the end of its useful life The pump has still not received a signal from the transmitter After multiple attempts the pump failed to detect the transmitter and is unable to receive sensor signal Next steps Change your sensor For details see your sensor user guide When you reconnected the transmitter to the sensor did you see a blinking green light on the transmitter Select Yes or No and follow the instructions on the screen Select OK to clear the alert e Repeat the connection pr
165. n 22 mmol L above the ow limit in 30 minutes after a maximum of two hours Resume basal alert When the Resume basal alert is on you will be alerted when insulin is automatically resumed If the Resume basal alert is off basal insulin resumes but you do not receive an alert However you will get a message indicating that the basal has automatically resumed If basal resumes after the maximum suspend time of two hours you will be alerted even if the Resume basal alert is set to off It is important that you check your BG and ensure your glucose is at a safe level For details on setting up the Resume basal alert see Setting up the Low Settings on page 171 164 Chapter 10 MP6025957 024 A SmartGuard suspend by sensor examples The following examples describe several scenarios that illustrate different types of suspend events user actions in response to these events and what happens to insulin delivery in each case Example 1 Suspend before low non responsive auto resume basal trending upwards Sarah has been experiencing low sensor glucose values Her healthcare professional has recommended she use the Suspend before low feature While at a concert Sarah s sensor glucose values are approaching her low limit Her pump recognizes that her glucose will be at or within 1 1 mmol L above her low limit within 30 minutes and suspends her insulin Sarah has her Alert before low set to off so that she is not alerted when thi
166. n one rate each with a separate start and end time The following example represents one basal pattern with three basal rates set for three different time periods 1 000 00 00 8 00 18 00 24 00 0 900 U hr 8 00 18 00 0 900 U hr U hr 00 00 600 12 00 18 00 24 00 24 Hours Your healthcare professional will determine what rates are right for you Note If you have alreadyset up basal patterns and want to switch from using one basal pattern to another see Changing from one basal pattern to another on page 46 Adding a new basal pattern This procedure shows you how to add a new basal pattern To add a new basal pattern 1 Go to the Basal Pattern Setup screen Menu Insulin Settings Basal Pattern Setup 42 Chapter 3 MP6025957 024 A The Basal Pattern Setup screen appears Your active basal pattern appears with a check mark and the 24 hour delivery amount as shown in the following example Basal Pattern Setup 0 04 Add New 2 If this is your first time setting up a basal pattern the unit amount will be 0 0 Select Basal 1 and proceed to step 5 If this is not your first time setting up a basal pattern proceed to the next step to add a new pattern 3 To add a new basal pattern select Add New The Select Name screen appears Select Name Basal 2 Day Off sick Day Note The Workday Day Off and Sick Day patterns are available so that you can match a basal pattern name t
167. n the screen instead Select Carbs to enter the amount of carbs in your food Review your calculated bolus amount in the Bolus field If you want to change the bolus amount select Bolus and make your desired change Remember if there is a correction bolus amount calculated you are not able to give a Square Wave bolus Note f you change your bolus amount the word Modified appears next to the new bolus amount Select Next to review your bolus information Select Square The Bolus Wizard screen appears with your bolus amounts To change the time period over which your bolus is delivered select Duration to adjust the time The duration can be from 30 minutes to 8 hours in 15 minute increments Select Deliver Bolus to start your bolus Chapter 4 MP6025957 024 A During a Square Wave bolus delivery the Bolus button on your Home screen appears as Bolus S You can select Bolus S to stop the bolus to see details on the insulin that has been delivered or to access the Bolus menu The Bolus menu provides access to the Bolus Wizard Manual Bolus Preset Bolus and Insulin Settings options Delivering a Square Wave bolus using Manual Bolus The Square Wave option is available in the Manual Bolus screen only after you turn on the Square Wave feature To deliver a Square Wave bolus manually 1 Go to the Manual Bolus screen Home screen Bolus Manual Bolus 2 Set your bolus delivery amount in units and then sel
168. nction Nearby Subpart C Section Power Pass electronic equipment may be 15 247 a 2 RSS 210 T og affected FAss DADO 705 DTS KDB 558074 ANSI C63 4 RSS Gen FCC Part 15 Section 15 109 Class B ANSI c63 4 2009 Emissions Pass Power Spectral Density Pass RF emissions Class B The MiniMed insulin pump is suitable for use in all establishments EN55011 2009 A1 including domestic and those directly RTCA DO 160G 2010 Complies connected to the public low voltage 20 5 and 215 power supply network that supplies buildings used for domestic purposes 262 Chapter 15 MP6025957 024 A Guidance and Manufacturer s Declaration Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below The customer or the user of the MiniMed insulin pump should assure that it is used in such an environment Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment Guidance Electrostatic discharge 8 kV contact 30 kV air For use in a typical ESD EEIE lt 5 relative domestic commercial IEC 61000 4 2 humidity or hospital environment Electrical fast transient 2 kV for power Not applicable Requirement does not burst supply lines apply to this battery IEC 61000 4 4 1 kV for input powered device output lines Surge 1 kV line s to Not applicable Requirement does not IEC 61000 4 5 line s apply to this battery 2 kV
169. nd or have insulin delivery suspended when you are either approaching or have reached your low limit This is done by using alerts and the SmartGuard feature described on page 152 The following graph shows the different low settings you can use Setting up Continuous Glucose Monitoring 157 MP6025957 024 A Suspend before low Alert before low Suspend on low Alert on low Low Limit WARNING SmartGuard suspend by sensor features are not intended to be a treatment for low blood glucose Having insulin suspended when glucose is low may not bring your blood glucose back to your target range for several hours Always confirm your blood glucose readings with your BG meter and treat according to the recommendations of your healthcare professional The following sections describe the SmartGuard feature and the low settings For details on setting up SmartGuard and your low settings see Setting up the Low Settings on page 171 Low limit The low limit is the value on which the other low settings are based The low limit can be set from 2 8 mmol L to 5 0 mmol L You can set up to eight low limits for different periods of the day or night Suspend before low The Suspend before low feature stops insulin delivery when your sensor glucose values are approaching your low limit This feature is intended to suspend insulin delivery to minimize the amount of time spent low The default setting for the Suspend before low feature is off C
170. ng 188 settings 33 167 signal alert 220 starting 182 status icons 153 MP6025957 024 A summary 120 trend arrows 153 wireless connection 175 179 Sensor alert occurred responding to 223 Sensor connected message 223 sensor Demo 146 Sensor expired alert 224 sensor glucose arrows 192 graph 191 high settings 156 history 191 low settings 157 review 122 rise alert 223 sensor alert occurred 223 sensor graph about 191 trend arrows 192 Sensor signal not found alert 224 serial number pump 12 Set Change reminder 133 settings basal 40 bolus 62 Bolus Wizard 65 CGM 156 low SG 157 product specifications 247 Startup 24 troubleshooting 229 SG average 120 SG Std Dev 120 SG value not available alert 225 silencing alerts 193 siren 201 sleep mode 35 SmartGuard about 152 icon 155 160 163 summary 121 Square Wave 60 about 76 Bolus Wizard 77 example 60 Manual bolus 79 resume message 214 215 setting up 77 starting sensor 182 Startup Wizard about 24 re entering settings 232 using 24 status bar about 28 Airplane Mode 29 audio mode 29 battery 28 Block Mode 31 CGM with 153 CGM without 26 Connection icon 29 icons 28 insulin amount 29 sensor calibration 30 sensor life 30 time 26 Status screens about 31 notifications 31 pump 31 quick status 31 sensor 31 settings review 32 stopping bolus 88 insulin delivery 54 storage mode 242 Stuck button alarm 215 summary screen about 117 basal 118
171. nge the sensor If the alert persists test your transmitter with the tester Refer to your transmitter user guide for instructions on testing the transmitter Select OK to clear the message For more information see Starting the sensor on page 182 Select OK to clear the alert e Check your BG If necessary treat your BG as directed by your healthcare professional Select OK to clear the alert e Check your BG If necessary treat your BG as directed by your healthcare professional Select OK to clear the alert e Recharge your transmitter Alarms alerts and messages 225 EY s 2 D et di gt 3 M N M un MP6025957 024 A CareLink alert and message The following table lists the most common or serious alarms alerts and messages related to CareLink The table also explains the meaning consequences and the Title and text Connect Device Device with SN XXXXXXXXXX IS trying to connect to your pump Allow connection Download slow Insulin delivery not affected CareLink download may take longer than usual Select OK to continue See User Guide 226 Chapter 12 Explanation The CareLink USB software is attempting to connect to your pump in preparation for data download The download of pump data is taking longer than expected Data will not be affected reasons why these notifications appear and provid
172. nguage Select Language 2 When the Select Time Format screen appears select a 12 hour or a 24 hour time format 24 Chapter 2 MP6025957 024 A otartup 1 3 Select Time Format 24 Hour When the Enter Time screen appears adjust the setting to the current time If you are using a 12 hour clock be sure to specify AM or PM Select Next otartup 2 3 Enter Time When the Enter Date screen appears adjust the Year Month and Day to the current date Select Next otartup 3 3 Enter Date Month Day A message confirms that your initial setup is complete and then the Home screen appears After you enter your initial settings see the following sections in this chapter to become familiar with the buttons and screens on your pump First steps 25 MP6025957 024 A Unlocking your pump Your pump automatically locks when entering sleep mode When you wake up your pump from sleep mode you must unlock your pump before navigating away from the Home screen When you press menu 8 or select O you will be shown a screen asking you to unlock your pump Press the highlighted button to unlock your pump Press key to unlock IN ve The pump will take you to your selected screen after you press the correct button If you press an incorrect button the following screen appears and you will need to select OK to return to your Home screen and try again After your pump is unlocked it will remain unlocked
173. nimum of every 12 hours throughout the life of the sensor If you are using a compatible Bayer meter you can set up your pump to calibrate automatically with each valid BG meter reading For more details see Setting up Auto Calibration on page 185 Note Sensor calibration is successful only if your BG entry is in the range of 2 2 to 22 2 mmol L Remember to calibrate three to four times throughout the day for optimal results To calibrate your sensor 1 Take a BG meter reading 2 Goto the Calibrate Sensor screen Menu Sensor Settings Calibrate Sensor 3 Select BG and enter the value 4 Select Calibrate 184 Chapter 10 MP6025957 024 A You can set up a reminder to notify you when your next calibration is due For more information see Calibration reminders on page 133 Setting up Auto Calibration The Auto Calibration feature determines how to calibrate the pump when using a wirelessly linked compatible Bayer meter When the Auto Calibration feature is turned on the pump uses any BG value in the range of 2 2 to 22 2 mmol L for calibration When this feature is turned off the pump asks you every time if you want to use the compatible Bayer meter for calibration To turn on Auto Calibration 1 Goto the Auto Calibration screen Menu Sensor Settings Auto Calibration 2 Select Auto Calibration to turn on the feature 3 Select Save Y Note f you decide not to use the Auto Calibration in the future selec
174. nsor signal make sure you are away from any electronic devices that might cause interference Setting up Continuous Glucose Monitoring 183 un M er em O o A 3 er 5 un c e un b 5 le e MP6025957 024 A 2 lf you have gone through all of the troubleshooting on your pump screen and your pump still cannot find the sensor signal contact your local help line or representative for assistance Calibrating your sensor Calibration is the process of entering a BG meter reading to calculate sensor glucose values You must calibrate your sensor regularly to ensure you continue to receive sensor glucose data For details see Guidelines for calibrating on page 187 Within two hours after you use your pump to start the sensor your pump displays a Calibrate now alert to let you know that a calibration is due This BG meter reading is the first calibration for your sensor lt takes up to 15 minutes after calibration to see the first sensor glucose reading on your Home screen You enter your second calibration within six hours after your first calibration After you have entered your first two calibrations you must calibrate your sensor again within 12 hours If you do not enter a BG meter reading within 12 hours your pump displays the Calibrate now alert and stops calculating sensor glucose values until a calibration BG is successfully entered The sensor must be calibrated at a mi
175. nt You should hear a confirmation tone or feel a vibration for each button press Count to ensure the amount is correct If the amount is not correct press and hold v until you hear a tone and then start again from step 1 Bolus 85 MP6025957 024 A 4 When the bolus amount is confirmed press and hold for about one second to deliver your bolus Your pump beeps or vibrates Your bolus starts immediately after the confirmation Note If you do not start your bolus within 10 seconds your Easy Bolus is cancelled and you receive a message letting you know that your bolus was not delivered Preset Bolus The Preset Bolus feature allows you to set up in advance bolus deliveries you expect to use frequently There are four Preset Bolus names that allow you to match a bolus to a meal with a known carb content Breakfast Lunch Dinner and Snack There are four additional Preset Bolus names that can be set for other circumstances Bolus 1 through Bolus 4 Note To set up a Dual Wave bolus or Square Wave bolus the Dual Wave or Square Wave feature must be turned on Setting up and managing Preset Bolus deliveries To set up Preset Bolus amounts 1 Go to the Preset Bolus Setup screen Menu Insulin Settings Preset Bolus Setup The Preset Bolus Setup screen appears showing any existing Preset Bolus settings 2 Select Add New The Select Name screen appears with the available Preset Bolus names 3 Select the Preset Bo
176. nually suspend insulin delivery at any time For details see Stopping and resuming your insulin delivery on page 54 Note The maximum amount of time the Suspend on low feature will be unavailable is four hours When the SmartGuard suspend by sensor features are unavailable the SmartGuard suspend by sensor icon on the Home screen appears gray A When a Suspend on low event occurs and you respond within two hours and Stay suspended for the two hour maximum suspend time the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes Your insulin automatically resumes due to your rising SG levels the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes Manually resume your basal insulin delivery the SmartGuard suspend by sensor features will be unavailable for 30 minutes after your basal insulin delivery resumes If your pump has been suspended for two hours and you have not responded basal insulin delivery automatically resumes If you respond within 30 minutes of basal insulin delivery being resumed the SmartGuard suspend by sensor features will be unavailable for a total of 30 minutes For example If you respond 10 minutes after your basal insulin delivery resumes the SmartGuard suspend by sensor features will be unavailable for an additional 20 minutes If you respond 20 minutes after your basal
177. o manually resume basal delivery 174 Chapter 10 MP6025957 024 A 1 From the Home screen select Suspended before low or Suspended on low The SmartGuard screen appears 2 Select Resume Basal 3 Select Yes to resume basal delivery Note Always remember to promptly respond to any confirmation messages shown on the pump screen Your prompt response is needed to complete the task Wirelessly connecting your pump and transmitter using Auto Connect Before you can start using your sensor you must first wirelessly connect your pump to your transmitter so they can begin communicating with each other The Auto Connect process locates your transmitter without having to enter the serial number of the transmitter into your pump manually Note the following before trying to connect your pump and transmitter e You can connect only one transmitter to your pump If you already have a transmitter connected to your pump you must delete it before continuing un M er em O E o A 3 er 5 un c e un b 5 le e For instructions on deleting a transmitter from your pump see Deleting the transmitter from your pump on page 181 Ensure that you are not close to other Medtronic devices that are in search mode before using Auto Connect For example if another household member is connecting a BG meter or transmitter to his or her insulin pump If you know multiple people are connect
178. o your insulin needs on those particular days 4 Select the basal pattern that you want to set up An edit screen appears for the pattern you selected The following example shows the Edit Workday screen Basal 43 MP6025957 024 A Edit Workday Start End 00 00 A Caution Insulin is delivered in units per hour If you set a basal rate of 0 025 U hr for a 30 minute time period this might result in no insulin delivered for that 30 minute period 5 To create one continuous 24 hour basal rate for your basal pattern continue with this step To create more than one basal rate for your new basal pattern skip to step 6 a Leave End time at 24 00 to set a 24 hour rate The Start time of the first time segment is always 00 00 D Set your rate in units per hour End Ufhr Opel rage 0788 C Skip to Step 7 6 To create more than one basal rate for your new basal pattern enter one basal rate at a time as described in the following steps a Set the End time and the Rate for your first basal rate You set your rates in 30 minute increments If you set the End time to anything other than 24 00 a second basal rate setting appears 44 Chapter 3 MP6025957 024 A Edit Workday Start End U hr 00 00 07 30 0 075 07 30 08 00 The Start time for the next rate is always the same as the End time of the previous rate 2 Note If you need to make a change you can press A to scroll up to the rate you wan
179. ocess Remove the transmitter from the sensor for about ten seconds and then reconnect it to the sensor e t can take up to 15 minutes for your pump to find the sensor signal e Move your pump closer to your transmitter to improve reception Make sure you are away from any electronic devices that might cause interference such as cellular phones and other wireless devices e If your pump still cannot find the sensor signal call your local representative for assistance MP6025957 024 A Title and text SG value not available If problem continues see User Guide Sensor warm up started Warm up takes up to 2 hours You will be notified when calibration is needed Suspend before low Delivery stopped Sensor glucose approaching Low Limit Check BG Suspend on low Delivery stopped Sensor glucose XX X mmol L Check BG Transmitter battery depleted Recharge transmitter now Explanation The sensor signals are either too high or too low Your sensor is warming up Your SG value is falling Insulin delivery is suspended according to your Suspend before low setting and your SG is approaching your specified low limit Your SG value is at or below the low limit you specified The battery in the transmitter needs to be recharged SG values are not recorded or transmitted until you recharge transmitter Next steps Select OK to clear the alert e You do not need to cha
180. ollowing space provided Find your serial number here Write it here Write your serial number here include any SN GTXXXXXXXX letters Medtronic Guardian Link REF MMT 7763A FCC ID XXXXXXX IC XXXXX XXXX 2 Attach your transmitter to the charger and make sure the transmitter is fully charged Keep your transmitter attached to the charger charger transmitter Setting up Continuous Glucose Monitoring 179 un D er em j A 5 er 5 O un ES e un M 3 er 5 MP6025957 024 A 2 180 1 Note Both lights on the charger are off when the transmitter is fully charged For more information see your transmitter user guide If you remove the transmitter from the charger to write down the serial number the green charger light may start flashing when you attach the transmitter to the charger again You can continue the connection process without waiting for the charger light to stop flashing On the pump go to the Enter Device SN screen Menu Utilities Device Options Connect Device Manual Connect Enter Device SN Use the pump navigation buttons to enter the serial number of the transmitter and select OK The New Device screen appears Select Search on your pump and immediately remove the transmitter from the charger New Device See User Guide to connect new device Select Search below when ready Th
181. on amount only D e Number of times the Bolus Wizard delivered a BG correction bolus only 4 Carb bolus BG e Total insulin units delivered using the Bolus Wizard with food Correction and BG correction amount Number of times the Bolus Wizard delivered a carb and BG correction bolus Manual Bolus e Total bolus insulin units delivered using Manual Bolus Preset Bolus or Easy Bolus Number of bolus deliveries using Manual Bolus Preset Bolus or Easy Bolus Summary screen BG meter The following table describes the BG meter portion of the Summary screen Name Description BG Total number of BG meter readings including readings from a compatible Bayer meter and BG meter readings entered manually Average BG Average BG meter readings Meter Low Lowest BG meter readings received from a compatible Bayer meter History and events 119 MP6025957 024 A Name Description Meter High Highest BG meter readings received from a compatible Bayer meter Manual Low Lowest BG meter readings entered manually Manual High Highest BG meter readings entered manually Summary screen sensor The following table describes the sensor portion of the Summary screen If the sensor feature has never been turned on this portion of the screen does not appear If the sensor feature was turned on at least once but is currently turned off this portion of the screen appears gray Name 5G Average 5G Std Dev Above High
182. onsult your healthcare professional for the Suspend before low setting that is best for you If you turn on Suspend before low then Alert on low is automatically turned on You also have the option to turn on Alert before low e If Alert before low is on your pump alerts you when insulin delivery is suspended For details see Alert before low on page 161 158 Chapter 10 MP6025957 024 A f Alert before low is off then Suspend before low appears on the screen but the pump will not beep or vibrate when insulin delivery is suspended WARNING The Suspend before low feature uses the sensor glucose value not your blood glucose value to automatically suspend insulin delivery Your pump automatically suspends insulin delivery when your sensor glucose is approaching the low limit However your blood glucose reading may be higher than the sensor glucose value This could result in hyperglycemia Likewise your pump may not suspend insulin delivery because your sensor glucose is not approaching the low limit However your blood glucose may be lower than the sensor glucose value This could result in hypoglycemia Always check your blood glucose and treat as appropriate Suspend before low conditions When a Suspend before low event occurs all insulin delivery is suspended For a Suspend before low event to occur both of these must happen Your SG value is at or within 3 9 mmol L above your low limit e Your SG is predicted to re
183. or PM 3 Select Save 148 Chapter 9 MP6025957 024 A setting up continuous glucose monitoring MP6025957 024 A MP6025957 024 A Setting up Continuous Glucose Monitoring This chapter explains how to wirelessly connect your pump and transmitter and how to enter your sensor settings and set up continuous glucose monitoring CGM on your pump You will need the following MiniMed 640G insulin pump Sensor glucose settings provided by your healthcare professional Enlite sensor Guardian 2 Link transmitter kit WARNING Do not make therapy treatment decisions based on sensor glucose values because sensor glucose and blood glucose values may differ If your sensor glucose reading is low or high or if you feel symptoms of low or high glucose confirm your blood glucose with your BG meter prior to making therapy decisions to avoid severe low or high glucose conditions Understanding Continuous Glucose Monitoring CGM The Sensor feature on the pump lets you integrate and use continuous glucose monitoring CGM CGM is a sensor glucose monitoring tool that uses a glucose sensor that is placed below your skin to continuously measure the amount of glucose in your interstitial fluid CGM helps you better manage your diabetes by Recording your glucose values throughout the day and night Setting up Continuous Glucose Monitoring 151 un M er em O o A 3 er 5 un c e un b
184. or basal amounts in the range to 9 95 units e 0 1 units per hour for basal amounts of 10 to 35 units 8 3 3 to 13 9 mmol L None The most recent BG value received from the meter If you are using a compatible Bayer meter this value appears on the Home screen when the Sensor feature is off This value also appears in the Bolus Wizard screen when setting up a bolus Expiration Range Bolus delivery Bolus Speed options Bolus programming increments 250 Chapter 15 12 minutes 1 1 t 33 mmol L e Standard 1 5 units minute e Quick 15 units minute 0 025 units e 0 05 units e 0 1 units MP6025957 024 A Fluid delivered stroke e 0 25 uL microliter for 0 025 unit pump stroke e 05 uL for 0 05 unit pump stroke e 20 uL for 0 2 unit pump stroke Bolus Wizard feature default settings Item Default Limits Increments Carb units grams Insulin to carb or None 1 200 g u 0 1 g u for 1 9 9 g u exchange ratio 0 075 15 0 u exch 1 g u for ratios of 10 g u to 200 g u 0 001 u exch for 0 075 0 099 u exch 0 01 u exch for 0 10 9 99 u exch 0 1 u exch for 10 15 u exch Insulin Sensitivity None 0 3 22 2 mmoalfL 0 1 mmol L Factor BG Target None 3 3 13 9 mmol L 0 1 mmol L Active Insulin 6 hours 2 10 8 hours 15 minutes Time Lo je Q c A et Uu Lo D A e A 0 Uu 0 Q N et lt 3 0 O Bolus Wizard feature specifications Ther
185. our BG Follow instructions from your healthcare professional and continue to monitor your BG e Your pump has resumed basal insulin delivery however your SG value is still at or below your low limit Select OK to clear the alert e Check your BG Follow instructions from your healthcare professional and continue to monitor your BG e Move your pump and transmitter closer together Select OK Your pump tries again to send your BG to your transmitter for sensor calibration MP6025957 024 A Title and text Calibrate now Check BG and calibrate Sensor Calibration not accepted Recheck BG and calibrate Sensor Explanation A BG meter reading is needed immediately to calibrate your sensor so that you can continue receiving sensor glucose readings Your system was unable to use the BG meter readings you entered to calibrate your Sensor Next steps e Take BG meter reading and enter for calibration After you receive a Calibrate now alert it takes up to 15 minutes after you calibrate for your pump to receive SG values For details see Calibrating your sensor on page 184 If you are unable to calibrate now you can use the Snooze feature Set the desired time and select Snooze If you do not calibrate before the Snooze time is up the Calibrate Now alert occurs again e Wash and dry hands thoroughly See Guidelines for calibrating on page 187 e Ente
186. p Basal rate about 40 starting 51 Preset Temp basal rate about 49 editing 50 managing 49 setting Up 49 previous screen 21 pump alarms 202 226 alerts 202 226 buttons 20 cleaning 241 connecting transmitter 175 179 connection status 29 deleting transmitter 18 messages 202 226 navigation 24 notification light 20 overview 19 parts illustration 19 rewinding 94 settings 232 storing 242 unlocking 26 Pump error alarm 212 213 Pump restarted alarm 213 pump settings clearing 143 managing 142 restoring 143 saving 142 specifications 247 viewing history 145 Q quick status 31 Quick set infusion set disconnecting 107 reconnecting 108 R rate basal about 39 Preset lemp 40 Temp 40 47 rate of change arrows 153 red light 201 reminders about 129 Bolus BG Check 130 Calibration 133 Low Reservoir 132 Menu screen 33 Missed Meal Bolus 131 Personal 129 Set Change 133 remote bolus 62 112 Replace battery alarm 213 214 reservoir about 93 compartment image 19 inserting 99 Loading incomplete alarm 209 Low Reservoir alert 210 Max Fill reached alarm 210 211 Menu screen 33 No reservoir detected alarm 211 ordering 15 plunger rod 97 removal 93 Reservoir estimate at OU 214 setting up 93 transfer guard 97 type 13 Reservoir estimate alert 214 restoring pump settings 143 Resume basal alert 164 Index 293 MP6025957 024 A Resume bolus message 214 Resume Dual bolus message 214 215 Resume Square bolus message
187. protected against the effects of being underwater to a depth of up to 3 6 meters 12 feet for up to 24 hours 8 Chapter 1 MP6025957 024 A If the pump is dropped hit against a hard object or otherwise damaged the waterproof characteristics of the outer casing of the pump may be compromised IF your pump has been dropped or you suspect your pump is damaged carefully inspect your pump to ensure there are no cracks before exposing your pump to water If you believe that water has entered your pump or you observe any other possible pump malfunction check your blood glucose and treat high blood glucose as necessary using an alternative source of insulin Contact your local representative for further assistance Always contact your healthcare professional if you experience excessively high or low blood glucose levels or if you have any questions about your care Electrostatic discharge Although your MiniMed 640G insulin pump is designed to be unaffected by typical levels of electrostatic discharge ESD very high levels of ESD can result in a reset of the pump s software and a pump error alarm After clearing the alarm verify that your pump is set to the correct date and time and that all other settings are programmed to the desired values because the software reset could erase your previously programmed settings For more information on pump alarms see Pump alarms alerts and messages on page 202 For more information on re ente
188. pump prior to using your pump with insulin you must clear the active insulin This ensures that the Bolus Wizard has an accurate active insulin amount for bolus calculations You can clear your active insulin only once After you clear your active insulin the feature is no longer available 1 144 Go to the Manage Settings screen Menu gt Utilities gt Manage Settings Simultaneously press and hold gt and until the Manage Settings menu appears The Manage Settings screen appears If you have never cleared your active insulin the Clear Active Insulin option appears Chapter 9 MP6025957 024 A Manage Settings Save Settings Restore Settings Clear All Settings Settings History Note If the Clear Active Insulin selection does not appear on the Manage Settings screen it means that you have already cleared your active insulin on the pump 3 Select Clear Active Insulin A confirmation screen appears asking if you want to continue 4 Select Clear to clear your active insulin value from your pump If you do not want to clear your active insulin at this time select Cancel A message appears confirming that your active insulin value is cleared Viewing your pump setting history The Settings History shows you a history of activities you have performed in the Manage Settings area such as saving restoring or clearing your settings 1 Goto the Manage Settings screen Menu Utilities Manage S
189. r a new BG meter reading for calibration as instructed in Calibrating your sensor on page 184 If you receive a Calibration not accepted alert on your second calibration a Change sensor alert occurs Call your local representative if you have questions Alarms alerts and messages 219 EY s 2 D et di gt 3 D N M MP6025957 024 A Title and text Cannot find sensor signal Disconnect and reconnect transmitter then select OK Notice if transmitter light blinks Change sensor Insert new sensor and Start New Sensor Change sensor Second calibration not accepted Insert new sensor Change sensor Sensor not working properly Insert new sensor 220 Chapter 12 Explanation The pump has not received a signal from the transmitter You selected No in the Check sensor insertion Message indicating that your sensor is not fully inserted This alert occurs when you receive two Calibration not accepted errors in a rOW Sensor signal is no longer reliable Next steps Disconnect and reconnect your transmitter and sensor e See if the light on your transmitter blinks when connected to the sensor You may need this information for troubleshooting later e Select OK Your pump searches for your sensor If your pump receives a signal from your sensor you do not need to do anything else If your pump does not receive a s
190. r the reminder 3 Select Save Calibration reminders The Calibration reminder is available if you are using the Sensor feature This feature helps you remember to calibrate your sensor For example if you set your reminder to four hours you receive a Calibrate By alert four hours before the next BG meter reading is due To turn on or off or change the Calibration reminder 1 Goto the Calibration screen Menu Reminders Calibration Reminders 133 MP6025957 024 A 2 Select Reminder to turn the reminder on or off 3 f you turn on the reminder select Time and enter a time between 5 minutes and 6 hours A Select Save 134 Chapter 8 MP6025957 024 A spuras e19usb MP6025957 024 A MP6025957 024 A General settings This chapter provides information about common tasks for various settings Airplane Mode Airplane Mode temporarily stops wireless communication with your pump Use this mode during airline travel when you are instructed to turn off wireless devices Check airline policies for specific instructions about operating medical devices during a flight Check local airport policies for specific instructions about medical devices and security procedures The following table provides special instructions when using Airplane Mode and additional devices with your pump When using this device Compatible Bayer meter Non linked BG meter Do this When Airplane
191. rams Carb ratio Units of insulin Correction estimate Current BG Low BG Target Insulin sensitivity Units of insulin Total bolus estimate Chapter 15 MP6025957 024 A Food estimate Correction estimate Units of insulin If your current BG is between or equal to your High or Low BG Target the total bolus estimate is based only on the food estimate food estimate total bolus food grams estimate carb ratio Food estimate Carb grams Carb ratio Units of insulin Note When the current BG is below the Low BG Target an active insulin amount is not considered in the Bolus Wizard feature calculations Total bolus estimate Food estimate If you do not enter a BG the total bolus estimate is based only on the food estimate Following are some notes about using the Bolus Wizard If a Dual Wave bolus is less than the estimate due to the Max Bolus limit or a change that you make the Square portion is reduced first Based on the Active Insulin Time setting you choose your pump keeps track of how much insulin is still active in your body This is shown as Active Insulin or Act Ins on the Home screen Bolus screen Manual Bolus screen Preset Bolus and Daily History screens This prevents stacking of insulin and lowers the chances of hypoglycemia The Bolus Wizard feature may utilize your current BG measurement carbohydrate consumption and active insulin to calculate your estimated bolus A
192. ratios using different time segments The time segments must cover a 24 hour period Bolus 67 MP6025957 024 A 68 Edit Carb Ratio 1 4 Start End 00 00 24 00 Note Your pump uses grams as the default carb unit If you would like to change your carb unit to exchanges see Carb Unit on page 140 If your ratio value is outside the range of 5 to 50 grams per unit or 0 3 to 3 units per exchange a message appears asking you to confirm your setting When the Edit Sensitivity screen appears enter your insulin sensitivity factor You can set up to eight different sensitivity factors using different time segments The time segments must Cover a 24 hour period Edit Sensitivity 2 4 Start End mmol L per U 00 00 24 00 If the value you enter is outside the range of 1 1 to 5 6 mmol L a message appears asking you to confirm your setting When the Edit BG Target screen appears enter your Bolus Wizard BG target range You can set up to eight different BG target ranges using different time segments The time segments must cover a 24 hour period Chapter 4 MP6025957 024 A Edit BG Target 3 4 Start End Lo Hi mmol L 00 00 24 00 If your BG target is outside the range of 5 0 to 7 8 mmol L a message appears asking you to confirm your setting 6 When the Active Insulin Time screen appears enter your active insulin time value Select Save A message appears letting you know the Bolus Wiza
193. rd setup is complete You can now use the Bolus Wizard to calculate a bolus Changing your Bolus Wizard settings This section shows you how to make changes to your personal settings after you initially set up the Bolus Wizard These settings are available only if the Bolus Wizard is turned on Changing your carb or exchange ratio You can change either your carb ratio or exchange ratio setting depending on whether you use grams or exchanges as your carb unit The carb ratio and exchange ratio settings are available only if the Bolus Wizard is turned on Note Your pump uses grams as the default carb unit If you would like to change your carb unit to exchanges see Carb Unit on page 140 Bolus 69 MP6025957 024 A To change your carb or exchange ratio 1 4 Go to the Carb Ratio screen or the Exchange Ratio screen depending on the carb units you use Menu Insulin Settings Bolus Wizard Setup Carb Ratio or Menu gt Insulin Settings gt Bolus Wizard Setup gt Exchange Ratio Select Edit Select the carb or exchange ratio to adjust the Start time the End time and the ratio You can set up to eight different carb or exchange ratios using different time segments The time segments must cover a 24 hour period If you set a value outside the typical range of 5 to 50 grams per unit or 0 3 to 3 units per exchange a message appears asking you to confirm your setting When you have made your changes se
194. re You select from specific bolus settings Wave bolus Dual Wave that you define ahead of time for bolus recurring situations For details about using the Preset Bolus feature see Preset Bolus on page 86 Bolus 6 MP6025957 024 A Delivery Type of bolus available method Easy Bolus Normal bolus Remote Bolus Normal bolus or any from your Preset Bolus set up on compatible your pump Bayer meter Bolus settings How it works After the Easy Bolus feature is set up you can deliver a Normal bolus by using the A button when the pump is in sleep mode For details about using the Easy Bolus feature see Fasy Bolus on page 83 For information on using the Remote Bolus feature on your compatible Bayer meter see the user guide that came with your compatible Bayer meter For information on turning on the Remote Bolus feature on your pump see Setting up Remote Bolus on page 112 The following table describes some bolus settings that may need to be changed before you use your bolus options Consult with your healthcare professional for the settings that are right for you Note There are additional settings required if you want to use the Bolus Wizard These are described in the section Bolus Wizard on page 65 Setting What it is Max Bolus Maximum amount of bolus insulin in units your pump can deliver in a single bolus 62 Chapter 4 What it does for you Provides a safety measure by limiting th
195. ren and displays the emergency message 166 Chapter 10 MP6025957 024 A About three hours later Michael s roommate comes home He hears the pump sirening and wakes up Michael Michael clears any messages by selecting OK He sees that his basal insulin was suspended for the two hour maximum and had automatically been resumed He checks his blood sugar and sees that it is within the target range 1 1 above Low Limit A E E mmm ei mum nd my va gt a f S Low Limit 2 hours aD Since Michael has responded to his alert the pump will suspend insulin delivery and alarm again if his sensor value reaches or falls below his low limit again Turning on the Sensor feature You must turn on the Sensor feature before you can set up your glucose alerts and start monitoring your sensor glucose To turn on the Sensor feature 1 Go to the Sensor Settings screen Menu Sensor Settings 2 Select Sensor to turn on the sensor feature The sensor settings become accessible Setting up the High Settings The steps below guide you through setting up your high settings For details on your high settings see High settings on page 156 Setting up Continuous Glucose Monitoring 167 un D er em 5 o A 5 er 5 un ES A un M 3 5 zt e MP6025957 024
196. res The History screens provide personal pump therapy details including information about your insulin deliveries BG meter readings sensor glucose SG readings and any alarms and alerts you received The Event Markers feature allows you to enter and save information such as manual BG readings carbohydrates eaten and exercise History The History feature includes the Summary Daily History and Alarm History screens The SG Review and ISIG History screens are available if you are using the Sensor feature Summary screen The Summary screen shows details about past insulin deliveries and meter readings If you are using a sensor the Summary screen also shows information about your sensor alerts and sensor glucose readings You can view historical details for a single day or you can select multiple days to view an average of all the results for the number of days that you selected To view your Summary screen 1 to the Summary screen Menu History Summary 2 Select the time period for the Summary screen The Summary screen appears showing information for the number of days that you selected History and events 117 H N et 2 lt 5 o b lt b et un MP6025957 024 A 3 You can scroll down to view the entire screen If you are using the 1 Day view you can use the lt and gt buttons on your pump to view the results for each day in history Understanding the Summary screen
197. ring your pump settings see My pump is asking me to enter my settings on page 232 If you are unable to re enter your pump settings or otherwise believe there is a problem with your pump contact your local representative Avoid extreme temperatures Exposure to extreme temperatures can damage your device which can adversely affect safety and effectiveness of your device Avoid the following conditions 1 Avoid exposing your pump to temperatures above 40 C 104 F or below 5 C 41 F because this may damage your device 2 Insulin solutions freeze near 0 C 32 F and degrade at high temperatures If you are outside in cold weather wear your pump close to your body and cover it with warm clothing If you are in a warm environment take measures to keep your pump and insulin cool Before you begin 9 O 1 lt O c MP6025957 024 A 3 Do not steam heat sterilize or autoclave your pump Exposure to high temperatures may damage your device Lotion sunscreen and insect repellent Some skin care products such as lotion sunscreen and insect repellents can cause damage to plastics which is a material used in your pump case After using such products be sure to wash your hands prior to handling your pump If you get any skin care products or insect repellents on your pump wipe them off as soon as possible with a damp cloth and mild soap For instructions on cleaning your pump see
198. rm History screen displays a list of alarms and alerts that occurred on the selected day The list displays the most recent alarm or alert first From this list you can display further details about any alarm or alert To view your Alarm History ls Go to the Alarm History screen Menu History Alarm History A list of dates appears Select a specific date of alarm history to view A list appears showing any alarms or alerts that occurred on the specified day You can select any alarm or alert in the list to open the Alarm Detail screen which displays more information about the selected alarm or alert Using Sensor Glucose Review The Sensor Glucose Review feature allows you to view a graph of your SG history based on high and low limits you enter You can view information for one day or view an average of your SG data over a number of days This Sensor Glucose Review feature is available if you are using the Sensor feature Z Note The limits that you set in this screen are for the purpose of viewing your sensor glucose data only and are not the same as the High and Low Alert Limits used for your sensor alerts Changing your Sensor Glucose Review limits does not affect your high and low glucose limits To review your sensor glucose history lla 122 Go to the SG Review screen Menu gt History gt Sensor Glucose Review The SG Review screen appears The high and low limits that appear are either the v
199. rmation Insert the reservoir into the top of the reservoir compartment Turn the tubing connector approximately a half turn clockwise until the connector is locked The tubing connector should be aligned horizontally with the pump case as shown in the following example Your pump should be displaying the New Reservoir screen shown in the following example Select Next to continue New Reservoir 3 Place reservoir into pump and lock DO NOT CONNECT TO BODY Chapter 5 MP6025957 024 A Note If the New Reservoir screen has timed out and the Home screen appears select Load Reservoir from the Home screen After the New Reservoir screen appears you may have to select Next to get to the screen shown previously Vis 6 When the reservoir is inserted select and hold Load until you see a checkmark on the screen and your pump beeps or vibrates Holding Load moves the piston up in the reservoir compartment until it engages with the bottom of the reservoir Load Reservoir Select Load and hold until complete DO NOT CONNECT TO BODY D un M lt o 2 5 c v o N M et Note If you press the Back button after the loading process begins a Loading incomplete alarm will occur When the loading process is completed the following screen appears Load Reservoir Complete DO NOT CONNECT TO BODY Select Next to continue 8 Follow the instructions in
200. rning If you give boluses to cover your mid morning snack and your lunch the number of hours remaining decreases accordingly and your insulin will run out before you end your eight hour work day WARNING When the pump detects a low reservoir condition during a bolus or fill cannula delivery the Low reservoir alert displays When delivery has finished check the amount left in the reservoir to make sure your pump does not run out of insulin as this could lead to an under delivery of insulin 152 Chapter 8 MP6025957 024 A Low Reservoir reminder setup 1 Go to the Low Reservoir screen Menu Reminders Low Reservoir 2 Select Type to set the reminder using either Units or Time 3 Depending on the type you selected do one of the following Select Units to enter the number of units You can set a value from 5 units to 50 units Select Time to enter the number of hours you want to use for your reminder You can enter from 2 to 24 hours 4 Select Save Set Change reminder The Set Change reminder helps you remember to change your infusion set After you turn on this reminder it automatically tracks the time between infusion set changes and reminds you to change your infusion set To turn on or off or change the Set Change reminder 1 Goto the Set Change screen Menu gt Reminders Set Change 2 Select Reminder to turn the reminder on or off If you turn on the reminder select Time and choose two or three days fo
201. rns off Z Note The search process can take up to two minutes You cannot access your pump screens or suspend your pump during the search process When your pump finds the transmitter the Confirm Device SN screen appears Ensure the transmitter serial number on your pump screen matches the serial number on the back of your transmitter and then select Confirm Setting up Continuous Glucose Monitoring 177 un D er em 5 o A 5 er 5 un ES A un M 3 5 zt e MP6025957 024 A Confirm Device SN New Device SN GT6004343M Cancel If the connection is successful your pump displays a success message If the Sensor feature is turned on the Connection icon appears on the status bar If your pump does not find your transmitter see the following procedure f your pump does not find your transmitter If your pump finds multiple devices skip to the steps on page 178 If your pump does not find your transmitter ly Place the transmitter back on the charger and make sure your transmitter is fully charged before continuing Place your pump and transmitter within an arm s length of each other Select Retry on your pump and immediately remove the transmitter from the charger to start the search process If the search is unsuccessful the second time select Cancel when the No Devices Found message appears and then follow the instructions in Wirelessly connectin
202. rom the list For more information on alarms and alerts see the Alarms alerts and messages chapter A summary of status information including your last bolus last BG meter reading current basal rate reservoir level and pump battery charge level If you are using a sensor this screen also displays the time that your next calibration is due and the SmartGuard status Provides a detailed view of your pump status including whether your pump is in a specific mode the reservoir status battery status the pump serial number and other details about your pump The Sensor status screen is available only if your sensor feature is turned on The Sensor status screen indicates if any alert silence options are turned on It also shows the status of your calibrations your sensor life ISIG transmitter battery serial number and version number of your transmitter and the SmartGuard status First steps 3 MP6025957 024 A Status screen Displays this information Settings The Settings Review screen provides a list of all your pump settings Review The settings are organized by where they appear in the menu for your pump For example your bolus settings appear under the Insulin Settings section and your brightness level setting appears under the Utilities section Viewing the Status screens 1 Go to the Home screen 2 Select the status bar that appears at the top of the Home screen E Active Insulin 1 00 Bolus Basal T
203. s Max bolus Bolus BG Check Reminder 256 Chapter 15 Default setting Off Off ou 0 10 U Off 10 U Off Limits 0 1 Uto 2 U 0 025 U 0 05 U 0 10 U O to 75 U per single bolus 0 00 to 5 00 Increments 0 30 MP6025957 024 A Basal settings Item Default setting Limits Increments Max Basal Rate 2 U h 0 35 U h 0 025 U for 0 025 0 975 U h 0 05 U for 1 00 9 95 U h 0 1 U for rates of 10 0 U h or more Basal Rate 0 000 U h 0 000 U h to Max 0 025 U for Basal Rate setting 0 025 0 975 U h 0 05 U for 1 00 9 95 U h 0 1 U for rates of 10 0 U h or more Temp Basal Type Percent Percent Rate N A Temp Basal 10096 0 200 5 Percent 0 025 U for 0 025 0 975 U h 0 05 U for 1 00 9 95 U h 0 1 U for rates of 10 0 U h Temp Basal Rate Current basal rate Lo je Q c A et Uu Lo A e A Q Uu tU Q N et lt 5 3 0 O or more Insulin sensitivity factor Maximum settings 8 Default None Insulin sensitivity is set during Startup of the Bolus Wizard Range 0 3 to 22 2 mmol L unit Low Reservoir reminder The values are based on displayed amount not actual amount Product specifications and safety information 257 MP6025957 024 A Alert Alert range Increment Default type value Time First reminder occurs at 2 to 24 hours Second 30 min 8 hours reminder occurs one hour before empty The second reminder is automatic an
204. s 2 Select Max Bolus 3 Because the Max Bolus setting determines your bolus insulin limit a warning message appears any time you go to the screen to change the value To continue to the Max Bolus screen select Continue Bolus 63 MP6025957 024 A 4 Select Max Bolus and then set the maximum number of insulin units your pump can deliver in one bolus 5 Select Save Bolus Increment The Bolus Increment setting determines the number of units that are increased or decreased with each button press when you adjust your bolus delivery amount in the Bolus Wizard Manual Bolus and Preset Bolus screens Depending on your typical bolus amount you can set your increment to 0 1 units 0 05 units or 0 025 units Note Fasy Bolus uses a setting called Step Size to determine the number of insulin units for each button press See Setting up Easy Bolus on page 84 for more information To set your Bolus Increment 1 Go to the Bolus Increment screen Menu Insulin Settings Bolus Increment 2 Select Increment to set your desired increment value 3 Select Save Bolus Speed Bolus Speed sets the rate at which your pump delivers bolus insulin You can set a Standard rate 1 5 units per minute or a Quick rate 15 units per minute To set your Bolus Speed 1 Go to the Bolus Speed screen Menu Insulin Settings Bolus Speed 2 Select Standard or Quick 3 Select Save 64 Chapter 4 MP6025957 024 A Bol
205. s Saving a record of your settings allows you to restore your settings at a later date if necessary To save your current settings 1 Go to the Manage Settings screen Menu Utilities Manage Settings 2 Simultaneously press and hold gt and amp until the Manage Settings menu appears 3 Select Save Settings 142 Chapter 9 MP6025957 024 A If these are the first settings you have saved a message appears telling you that your settings are saved If you have previously saved settings a message appears asking if you would like to replace your previous settings with your current settings Select Yes to accept Select No to cancel Restoring your settings This option allows you to replace your current pump settings with the last settings that you have saved The Restore Settings menu option is available only if you have previously saved your settings To restore your previous settings 1 Go to the Manage Settings screen Menu Utilities Manage Settings 2 Simultaneously press and hold gt and amp until the Manage Settings menu appears 3 Select Restore Settings 4 replace your current settings with your previous settings select Yes To cancel select No Clearing your settings The Clear All Settings feature erases your current settings and returns them to the factory defaults After you clear your settings your pump displays the Startup Wizard where you can re enter your pump settings You m
206. s entered but bolus was not delivered within 30 seconds The battery power was exhausted while a bolus or Fill Cannula was in progress e You may be trying to connect a device that is not compatible with your pump You are trying to connect a transmitter to your pump but another transmitter is already wirelessly connected to your pump Some settings have been cleared or reverted to factory default values Next steps Select OK to clear the alert e If bolus delivery was intended check your BG re enter bolus values and deliver bolus Note the amount of insulin not delivered e Replace the AA battery Select OK to clear the alarm e Deliver the remaining bolus amount if needed Select OK to clear the alert Check the list of devices that are compatible with your pump in Optional devices on page 14 e If you are replacing your transmitter make sure that you first delete the old transmitter from your pump before you try to connect your new transmitter Only one transmitter can be connected to your pump For details see Deleting the transmitter from your pump on page 181 Select OK to clear the alert e Review any settings that you have not already set in Startup Wizard and re enter the values if necessary MP6025957 024 A Title and text Critical pump error Delivery stopped Pump not working properly Stop using pump Remove infusion set from bo
207. s The Low Settings screen appears Select Setup Select Edit Select and if needed adjust the time segment you would like to change Setting up Continuous Glucose Monitoring 173 un M er em E o A 5 er 5 un c e un b 5 le e MP6025957 024 A 5 Select any alert setting to turn it on or off or to adjust the setting 6 Select Next Select Done 8 Review your settings and select Save Low Snooze Low Snooze is available once you have set your Low Settings Low Snooze allows you to set the amount of time that you want to wait before you are reminded that an alert condition still exists After a low alert is received and cleared you will be alerted again only if the low alert condition still exists after the snooze time you have set Setting the Low Snooze 1 Goto the Low Settings screen Menu Sensor Settings Low Settings The Low Settings screen appears 2 Select Snooze and enter a time between 5 minutes and 1 hour Manually resuming basal delivery during a suspend by sensor event When your pump suspends insulin due to a Suspend before low or Suspend on low event the bottom of your Home screen displays either Suspended before low or Suspended on low depending on which is active If you do not want to wait for your pump to automatically resume your basal insulin you can follow the procedure below to manually resume your basal delivery T
208. s BG Check 2 To turn the reminder on or off select Reminder 3 Select Save To use a Bolus BG Check reminder when delivering a bolus 1 After you turn on the Bolus BG Check reminder each time you start a bolus the following screen appears 130 Chapter 8 MP6025957 024 A BG Check No Reminder 2 Enter a time from 30 minutes to 5 hours in 30 minute increments Select OK If you do not want a reminder after the bolus select the dashes without adding a time and then select OK If needed press v to return to the dashes Missed Meal Bolus reminder The Missed Meal Bolus reminder alerts you if a bolus is not delivered within a time period that you set These time periods are usually set around your typical meal times to help ensure a meal bolus is not missed You can set up to eight Missed Meal Bolus reminders To create a new Missed Meal Bolus reminder 1 Goto the Missed Meal Bolus screen Menu gt Reminders gt Missed Meal Bolus 2 Select Add New 3 Select Start Time and enter a time 4 Select End Time and enter a time The time range is from one minute to 24 hours 5 Select Save To turn on or off change or delete existing Missed Meal Bolus reminders 1 Go to the Missed Meal Bolus screen Menu Reminders Missed Meal Bolus 2 Select one of the reminders that you have already created 3 Change any of the following Select Reminder to turn this reminder on or off Select Edit to change the ti
209. s occurs 3 9 above Low Limit 1 1 above Low Limit Low Limit An hour later her sensor glucose values are 1 2 mmol L above her low limit Her pump estimates her sensor glucose values will be 2 4 mmol L above her low limit within 30 minutes Her pump automatically resumes her basal insulin delivery When the concert ends Sarah sees that her pump automatically suspended and resumed her insulin delivery and a potential low was avoided She clears the messages by selecting OK Setting up Continuous Glucose Monitoring 165 un D er e j A 5 et 5 O un ES e un M 3 er 5 MP6025957 024 A Example 2 Suspend before low responsive manually resume basal Kate decides to meet her friends at the mall While shopping she gets a Suspend before low alert This indicates that her sensor glucose values are approaching the low limit she has set She clears the alert and sees that her insulin has been suspended Kate checks her BG to confirm Based on her healthcare professional s recommendation Kate stops for a snack to help avoid hypoglycemia Knowing the carbohydrate will make her glucose rise Kate manually resumes her basal insulin delivery by selecting Suspended before low from the Home screen and choosing Resume basal Kate knows that after she has manually resumed her basal insulin delivery the suspend functions will be unavailable for 30 minutes However she will be a
210. s the Airplane Mode icon X in place of the Connection icon Audio Options The Audio Options screen lets you change the volume of most alerts and notifications and set the audio and vibrate settings You can choose one of the three audio options 4 audio le e vibrate 2 138 Chapter 9 MP6025957 024 A audio and vibrate 2 The audio option that you are currently using displays on the status bar For more information see Status bar on page 28 To adjust the audio and vibrate settings 1 Go to the Audio Options screen Menu Audio Options 2 Select the Audio or Vibrate option you want to use 3 f Audio or Audio amp Vibrate option is selected the volume can be changed Select Volume and use left or right button to the desired level 4 Select Save Auto Suspend Auto Suspend is a safety feature that stops all insulin delivery and sounds an alarm if you do not press any buttons for a specified period of time For example your healthcare professional may have you set the time based on the number of hours that you typically sleep at night Discuss with your healthcare professional how to best use this feature To set up Auto Suspend 1 Go to the Auto Suspend screen Menu Insulin Settings Auto Suspend 2 Select Alarm 3 Select Time and enter the number of hours that you want to set 4 Select Save Block Mode The Block Mode feature allows caregivers such as parents of a young child
211. se the BG meter readings you entered to calibrate your sensor System rejects two calibrations in a row from the same sensor transmitter was unable to receive the calibration BG meter readings from the pump due to failed sensor signal For details on when and how to calibrate your sensor see Calibrating your sensor on page 184 Why does the SmartGuard suspend by sensor icon on my Home screen appear gray The SmartGuard suspend by sensor icon appears gray A on the Home screen when either the Suspend on low or Suspend before low feature is unavailable The suspend features may be unavailable due to the following conditions suspend event has occurred recently 236 Chapter 13 MP6025957 024 A After a Suspend before low or Suspend on low event occurs there is a period of time when the suspend functionality is unavailable This time will vary depending on whether or not you respond to the suspend event Typically the suspend features will be unavailable for 30 minutes after your basal insulin delivery is resumed For details see When Suspend before low is unavailable on page 160 or When Suspend on low is unavailable on page 163 e No SG values are available SG values may be unavailable because e Your pump is in Airplane Mode For more information see Airplane Mode on page 137 Sensor calibration is required For details on when and how to calibrate your sensor see Calibrating your sensor on pag
212. sensor Appears only when the Sensor feature is turned on The color and the fill level of the icon indicate the status When you insert a new sensor the icon is solid green As your sensor life is used the icon becomes emptier The icon turns yellow when less than 24 hours remains in the life of your sensor It turns red when less than 12 hours remains in the life of your sensor datada If the number of days remaining in the life of your sensor is unavailable the Sensor Life icon appears with a question mark 2 MP6025957 024 A Icon Icon name What it means Block Mode Indicates that the pump is in Block Mode and that 3 certain functions are restricted Caregivers such as parents of a young child can use Block Mode to restrict access to critical pump settings For more information about Block Mode see Block Mode on page 139 Temporary Appears while you are temporarily connected to a 9 Network remote upload device Connection Status screens The Status screens provide information about your pump any notifications you have received your current settings and optional sensor The Status screens are described in the following table Status screen Notifications Quick Status Pump Sensor Displays this information A list of alarms alerts and r minders that have occurred over the past 24 hours You can display further details about a particular alarm alert or reminder by selecting it f
213. ser software license agreement 2 3 End user software license agreement B Glossary B Index xii Contents no MP6025957 024 A MP6025957 024 A Before you begin This user guide is designed to help you understand the operation of your MiniMed 640G system Work closely with your healthcare professional when starting insulin pump therapy Using this user guide This user guide contains valuable information about using your new insulin pump To help you find the information you need you can use the table of contents at the beginning of the user guide and the index at the end of the user guide There is also a glossary of terms which starts on page 277 The following table describes certain terms conventions and concepts used in this user guide Convention What it means Select To activate a screen item accept a value or initiate an action Select and To perform an action using your pump screen press the Select hold button and hold until the action is complete Press To push and then release a button Press and To push and keep pressure on a button hold Bold text To indicate screen items and buttons For example Select Next to continue Before you begin 3 1 lt O c MP6025957 024 A Convention Note Caution WARNING Emergency kit What it means 7 Note note provides helpful information AN Caution A caution notif
214. sing Easy Bolus Initially you should use the Easy Bolus feature while looking at the pump screen as you count the tones or vibrations 84 Chapter 4 MP6025957 024 A Caution When using Audio Vibrate is possible that an Audio or Vibration notification may not occur as expected if the speaker or vibrator in your pump malfunctions This is most important when using the Easy Bolus feature or when your pump is in Manual Suspend where a missed notification may cause an over or under delivery of insulin Contact the 24 Hour HelpLine or your local representative with any concerns To use the Easy Bolus feature you need to put your pump into sleep mode by pressing and holding the Menu button for about two seconds To deliver a bolus using Easy Bolus 1 While your pump screen is in sleep mode press and hold for about one second After your pump beeps or vibrates release a You can now start programming your Easy Bolus J Note If your pump does not respond when you press it may not be in sleep mode even if the screen is dark 2 Press A the number of times needed to set your bolus amount Each time you press your pump sounds a tone or vibrates and your bolus amount increases by the number of units set for the step size Note You cannot use v to select the Easy Bolus values Pressing v cancels the Easy Bolus 3 When you have reached the desired bolus amount press and hold A to confirm the amou
215. stem and to help you manage your diabetes You can also create reminders for personal events Utilities Set up and manage the features and functions of your system First steps 23 MP6025957 024 A Scroll bar The scroll bar is located on the right side of the display as shown in the following example It appears only when there is more information available to view on the screen Press A or to move up or down the screen Menu Audio Options scroll bar History Reservoir amp Tubing Insulin Settings Power modes Your pump is designed to conserve battery power when you are not actively using the pump screens In this Your pump behaves like this mode Awake Your pump screen is on Unless you are actively using another screen your Home screen appears To wake up your pump from being in power save or sleep mode press any button If your pump has been in sleep mode the pump is locked To unlock your pump see Unlocking your pump on page 26 Power Your pump is fully functional but the screen goes dark to save power You save can set how long it takes for your screen to enter power save mode by changing the Backlight setting For more information see Display Options on page 141 f any button is pressed while the pump is in Power save mode the pump returns to the screen that was last displayed 34 Chapter 2 MP6025957 024 A In this Your pump behaves like this mode Sleep Your pump automatically
216. suspended For details see Suspend before low on page 158 You can also choose to have the Alert before low off Suspend on low The Suspend on low feature stops insulin delivery when your sensor glucose value reaches or falls below the low limit that you set When a Suspend on low event occurs all insulin delivery is suspended This feature is used for situations when you cannot respond to a low glucose condition It is intended to suspend insulin delivery and minimize the amount of time spent low Setting up Continuous Glucose Monitoring 161 un M er em O o A 3 er 5 un c e un b 5 le e MP6025957 024 A The default setting for the Suspend on low feature is off Consult your healthcare professional for the Suspend on low setting that is best for you If you turn on Suspend on low then Alert on low is turned on automatically For more information see Alert on low on page 164 A WARNING The Suspend on low feature uses the sensor glucose value not your blood glucose value to automatically suspend your pump Your pump may automatically suspend when your sensor glucose is at or below the low limit while your blood glucose is above that limit This could result in hyperglycemia Likewise your pump may not suspend even though your blood glucose is at or below the low limit This could result in hypoglycemia Always check your blood glucose and treat as appropriate
217. t Auto Calibration to turn off the feature Where to enter yourycalibration BG meter reading There are several screens on the pump where you can enter a BG meter reading for calibration These screens are described in the following table These options are available only if you are using a sensor and your transmitter is wirelessly connected with your pump 27 Note If you using a compatible Bayer meter want to calibrate using every valid BG meter reading sent to your pump you can use the Auto Calibration feature For details about Auto Calibration see Setting up Auto Calibration on page 185 Setting up Continuous Glucose Monitoring 185 un M er em O E o A 3 er 5 un c e un b 5 le e MP6025957 024 A Pump screen Home screen When the calibration option is available you can access the Calibrate Sensor screen First highlight the sensor graph on the Home screen Then press and hold the O button to access the calibration screen Calibrate Sensor screen Menu gt Sensor Settings gt Calibrate Sensor BG Meter screen The BG Meter screen appears automatically when your compatible Bayer meter sends a BG meter readings to your pump BG screen in Event Markers Menu gt Event Markers gt BG BG field in the Bolus Wizard screen Home screen Bolus Bolus Wizard When to calibrate Calibrate Description After warm up is complete
218. t Save Your pump displays an Active Insulin Cleared alert 6 Select OK Make sure that all of your settings such as basal rate are set as desired If you need to reapply your last saved settings by using the Restore Settings option as instructed in Restoring your settings on page 143 Storing your transmitter Always refer to your transmitter user guide for instructions on storing your transmitter Maintenance 243 5 et D Y gt e D MP6025957 024 A 244 Chapter 14 product specifications and safety information MP6025957 024 A MP6025957 024 A Product specifications and safety information This chapter provides detailed product specifications and safety information Product specifications This section provides detailed BROS Alarm and alert escalation C 9 5 The following alerts may escal iren oduct specifications e Alert before high Check connection e Alert before low x e Lost sensor signal e Alert on high e No calibration occurred e Alert on low e Possible signal interference Basal delivery resumed e Rise Alert e BG not received e Sensor expired Calibration not accepted e Sensor signal not found e Calibrate now e SG value not available Cannot find sensor signal Suspend before low only if Alert before low is on e Change sensor Transmitter battery depleted Product specifications and safety information 247 Lo Q c A et Uu Lo
219. t on high if you want an alert when you reach your high limit d Select Rise Alert if you want to receive an alert when your SG is rising quickly Skip to step 11 if you do not select Rise Alert If you turned on the Rise Alert you need to set the Rise Limit Scroll down and select Rise Limit to access this option The Rise Limit screen appears Y Custom 0 220 mmol min OK Select the arrow option one two or three arrows that corresponds to the rise rate you want to use To use a custom rate skip to the next step Select for an alert when your SG has been rising at a rate of 0 056 mmol L per minute or more Setting up Continuous Glucose Monitoring 169 un M er 5 o A 3 er 5 E un c e un b 5 le e MP6025957 024 A 13 Select for an alert when your SG has been rising at a rate of 0 111 mmol L per minute or more Select PP for an alert when your SG has been rising at a rate of 0 167 mmol L per minute or more Select OK and skip to step 11 Note These arrows appear on your Home screen to let you know the rate at which your SG has been rising To enter a custom rise limit do the following a Select Custom The Custom Limit screen appears D Select Rise Limit and set a rise rate from 0 050 to 0 275 mmol L min You set the rate in 0 005 mmol L min increments C Select OK to return to the Rise Limit screen and then select
220. t to change Adjust the End time or Rate values as desired Note that pressing A or v when a field is selected flashing adjusts the value of that field When there is no field selected pressing A or v allows you to scroll up or down the list of basal rates b Continue setting rates for different time periods as needed The End time for your last rate must be 24 00 as shown in the example below End Ufhr 00 00 07 30 UDS 07 30 0 025 18 00 24 00 0 050 When you finish setting your basal pattern select Done The Done option appears only when the last End time in your basal pattern is set to 24 00 A screen appears that allows you to review your basal pattern If you need to make any changes press to return to the previous screen Select Save To activate your basal pattern see Changing from one basal pattern to another on page 46 Basal 45 MP6025957 024 A Editing copying or deleting a basal pattern To edit copy or delete a basal pattern ls Go to the Basal Pattern Setup screen Menu Insulin Settings Basal Pattern Setup The Basal Pattern Setup screen displays all of your existing basal patterns Select the basal pattern you want to edit copy or delete Select Options Do one of the following Select Edit to adjust the End time or rate values for one or more of the basal rates in this basal pattern Select Copy to copy the basal rate information from the selected basa
221. table describes the glucose alerts that are silenced with each option This Alert Silences these alerts Silence setting High Alerts Only Alert on high Alert before high and Rise Alert High amp Low Alert on high Alert before high Rise Alert Alert on low Alert Alerts before low Suspend before low and Resume Basal Alert Using continuous glucose monitoring 193 E 5 A le 5 5 le E un a A o N M 3 le zi le 2 5 MP6025957 024 A This Alert Silences these alerts Silence setting All Sensor Alerts All of the alerts listed previously for High Low Alerts plus the following e All calibration alerts reminders or error messages e All alerts relating to sensor insertion including alerts about sensor warm up changing your sensor sensor expiration sensor errors connection issues and so on All alerts related to your transmitter including all alerts about your transmitter battery and all connection issues To silence Glucose alerts 1 194 Go to the Alert Silence screen Menu Sensor Settings Alert Silence Alert Silence High amp Low Alerts All Sensor Alerts Duration Select High Alerts Only High Low Alerts or All Sensor Alerts to set the alerts you want silenced Refer to the previous table for details about the alerts silenced with each selection 2 Note If you select All Sensor Alerts you will not receive any alerts rela
222. ted to your sensor glucose readings your sensor calibration requirements or your transmitter If a glucose alert occurs the notification light flashes and a message appears on your pump to let you know a silenced alert occurred but there is no vibration or beep You can view the specific alert in Alarm History For more information see Alarm History on page 122 Chapter 11 MP6025957 024 3 Set the Duration time from 30 minutes to 24 hours for which the alerts will be silenced and then select OK 4 Select Begin The Alert Silence settings immediately take effect and you are returned to the Sensor Settings screen To cancel Alert Silence 1 Go to the Alert Silence screen Menu Sensor Settings Alert Silence Alert Silence All Sensor Alerts silenced Time Remaining 0 30 hr 2 Select Cancel Alert Silence E un LJ A le 5 5 le E un e o u M 3 o pe le LJ Using continuous glucose monitoring 195 MP6025957 024 A 196 Chapter 11 MP6025957 024 A pue sya e suueye MP6025957 024 A MP6025957 024 A Alarms alerts and messages This chapter describes the general behavior of the most common and the most serious notifications and how to resolve them About alarms alerts and messages Your pump has a sophisticated safety network If this safety network detects anything unusual it conveys this information in the for
223. temp basal rate delivery is completed or cancelled The Temp Basal feature allows you to set and start a temporary basal rate immediately The Preset Temp feature allows you to set up a temp basal rate ahead of time for known situations You define temp basal rates and preset temp basal rates using either a percentage of your current basal pattern or by setting a specific rate as described in the following table This temp basal type Works like this Percent Delivers a percentage of the basal rates programmed in your active basal pattern for the duration of the temp basal rate The temp basal amount is rounded down to the next 0 025 units if your basal rate is set at less than 1 unit per hour or to the next 0 05 units if your basal rate is set at more than 1 unit per hour Temp basal rates can be set to deliver from 0 to 200 of your scheduled basal rate The percent amount you can use however is based on the largest basal rate scheduled during the temp basal duration and is limited by your max basal rate Rate Delivers a fixed basal insulin rate in units per hour for the duration of your temporary basal limited by your max basal rate To use the Temp Basal feature see Starting a Temp Basal rate on page 48 To use the Preset Temp Basal feature see Preset Temp basal rates on page 49 Basal 47 MP6025957 024 A Starting a Temp Basal rate When you start a temp basal rate your basal delivery changes to the temporary
224. th high in bolus followed by a carbs and fat which may delay digestion e When your meal bolus is combined with correction bolus for an elevated blood glucose For details about using a Dual Wave bolus see Dual Wave bolus on page 79 Bolus type example The following example shows how the different bolus types work Normal N bolus Square Wave S bolus Dual Wave D bolus E 5 e Bolus Ll o now an c Bolus over time Bolus over time 0 1 2 3 Hours Hours Hours 60 Chapter 4 MP6025957 024 A Bolus delivery options The following table describes the different ways you can deliver a bolus Delivery Type of bolus available How it works method Bolus Wizard Normal bolus Square You enter your BG meter reading and Wave bolus Dual Wave your carbs you plan to eat and then the bolus Bolus Wizard calculates an estimated bolus amount based on your individual settings For details about using the Bolus Wizard feature see Bolus Wizard on page 65 To deliver a e Normal bolus using Bolus Wizard see page 4 Square Wave bolus using Bolus Wizard see page 77 e Dual Wave bolus using Bolus Wizard see page 80 Manual Normal bolus Square You do your own calculation and Wave bolus Dual Wave manually enter your bolus amount bolus To deliver a e Normal bolus see page 75 e Square Wave bolus see page 79 e Dual Wave bolus see page 82 Preset Bolus Normal bolus Squa
225. the bolus was actually delivered e To cancel remaining amount of bolus select Cancel e To resume remaining amount of bolus select Resume e Check the message to see how much of the Dual Wave bolus was actually delivered e To cancel remaining amount of bolus select Cancel e To resume remaining amount of bolus select Resume MP6025957 024 A Title and text Resume Dual bolus XX of YY U delivered Resume delivery of ZZ U now and AA U Square for XX XX hr Resume Square bolus XX of YY U delivered for XX XX hr Resume delivery of ZZ U for hr Stuck button Button pressed for more than 3 minutes Explanation The Now portion of a Dual Wave bolus delivery has been interrupted because the pump battery was removed If it is within 10 minutes since this interruption you can resume this bolus The Square Wave bolus delivery was interrupted If it is within 10 minutes since this interruption you can resume this bolus The pump has detected that a button has been pressed for an unusually long time Next steps e Check the message to see how much of the Dual Wave bolus was actually delivered e To cancel remaining amount of bolus select Cancel e To resume remaining amount of bolus select Resume e Check the message to see how much of the Square Wave bolus was actually delivered e To cancel remaining amount of bolus select Cancel e To resume
226. ting in determining if any active insulin is still in your body from prior boluses This may help prevent hypoglycemia caused by over correcting for high blood glucose Your current active insulin amount displays on the Home screen and includes only the bolus insulin you have already received When you are using the Bolus Wizard the Bolus Wizard calculator uses your current active insulin value to determine if there is an active insulin adjustment needed The active insulin adjustment calculation considers both the bolus insulin that has already been delivered the amount shown on the Home screen as well as any insulin that is going to be delivered by an active Square Wave bolus WARNING Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen Manual injections are not accounted for in the active insulin amount Therefore the Bolus Wizard could prompt you to deliver more insulin than needed Too much insulin may cause hypoglycemia Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard Bolus Wizard warnings When you use the Bolus Wizard there may be times when you see one of the following Warning What it means What to do High BG Your BG meter reading is above Check for an occlusion 13 9 mmol L e Check ketones e Consider
227. to restrict access to critical pump settings AN Caution You can still manually suspend the pump while in block mode This could result in high blood glucose and ketoacidosis General settings 139 5 4 t un D e UM MP6025957 024 A When Block Mode is on you cannot start a new bolus delivery start a new basal pattern or start a new temp basal delivery However any previous bolus and basal deliveries continue normally and the pump user can stop a bolus delivery at any time When your pump is in Block Mode you can suspend insulin delivery receive SG values receive BG values from a compatible Bayer meter review history test the pump and clear alarms and alerts However you cannot change any settings WARNING Block Mode does not prevent Remote Bolus deliveries from your compatible Bayer meter When your pump is in Block Mode you can still deliver a bolus from your compatible Bayer meter using the Remote Bolus feature To turn Block Mode on or off 1 Go to the Block Mode screen Menu Utilities Block 2 Select Block Mode to turn the feature on or off 3 Select Save While Block Mode is turned on a lock icon displays on the status bar If you are turning on Block Mode a message appears asking if you would like to change your Remote Bolus setting as well This message appears only if the Remote Bolus setting was on 4 Select Yes to change Remote Bolus setting 5 Sele
228. ts are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures Reorient or relocate the receiving antenna e Increase the separation between the equipment and the receiver This device can generate use and radiate radio frequency energy and if installed and used in accordance with the instructions may cause harmful interference to radio communications If the device does cause interference to radio or television reception you are encouraged to try to correct the interference by one or more of the following measures e Decrease the distance between the transmitter and the insulin pump to 1 8 meters 6 feet or less e Decrease the distance between the meter and the insulin pump to 1 8 meters 6 feet or less e Increase the separation between the transmitter and the device that is receiving emitting interference If other devices that employ radio frequencies are in
229. ttery in your pump 4 Note Do not use cold batteries because the battery life may incorrectly appear as low This can cause a Battery Failed alarm on your pump Allow cold batteries to reach room temperature before you insert them in your pump First steps 21 MP6025957 024 A Inserting the battery Your pump does not ship with the battery cap on The battery cap is located in the pump box separate from the pump To insert the battery 1 Insert the new or fully charged AA battery making sure to insert the negative end first After you insert the battery the positive end is visible 22 Chapter 2 MP6025957 024 A 3 If this is the first time you have inserted a battery in your pump the Startup Wizard begins For more information about the Startup Wizard see Entering your startup settings on page 24 If this is not the first time you have inserted a battery into your pump the Home screen appears and the pump resumes your basal delivery Removing the battery Caution Do not remove the battery unless you inserting a new one or if you are storing your pump Your pump cannot deliver insulin while the battery is removed After removing an old battery be sure to replace it with a new battery within 10 minutes to clear the Insert battery alarm and avoid a Power loss alarm If power loss occurs you must re enter your time and date settings To remove the battery 1 Before removing a battery fro
230. ttings Default setting 13 8 mmol L Off Off 15 minutes Off Two up arrows 1 hour Low Default setting 3 4 mmol L Off Off Off Off 20 minutes Limits 5 6 to 222 mmol L 5 to 30 minutes up arrow 0 056 mmol L min 2 Up arrows 0 111 mmol L min 3 Up arrows 0 167 mmol L min Custom limit 0 050 to 0 275 mmol L min 5 minutes to 3 hours sensor settings Limits 2 8 to 5 0 mmol L 5 minutes to 1 hour Increments 0 2 mmol L 5 minutes 5 minutes Increments 0 2 mmol L 5 minutes MP6025957 024 A Low sensor settings Item Default Limits Increments setting Resume basal Off alert Uo 5 A et N o al e S c O 5 un h D et lt 5 h ES 3 D et 5 Product specifications and safety information 261 MP6025957 024 A Guidance and manufacturer s declaration Guidance and Manufacturer s Declaration Electromagnetic Emissions The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below The customer or the user of the MiniMed insulin pump should make sure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions 6 dB and 99 The MiniMed insulin pump must emit Bandwidths Pass electromagnetic energy in order to Test 47 CFR Part 15 Maximum Output perform its intended fu
231. until you re enter sleep mode For information about the different power modes or to put your pump to sleep see Power modes on page 34 Home screen The Home screen appears by default after you change the battery when you wake the pump from sleep mode and when you are not actively using another screen You can navigate to the Home screen from any other screen by pressing and holding the button for about one second 26 Chapter 2 MP6025957 024 A To see what your Home screen looks like if you use a sensor see Home screen with CGM on page 153 status bar current time BG meter readings Active Insulin 1 00 active insulin Basal amount bolus delivery basal delivery options options The following items appear on your Home screen Item Description Status bar Displays icons that show a quick status of your pump system For more information see Status bar on page 28 By selecting the status bar you can access more detailed status screens For more information see Status screens on page 31 Current Displays the current time of day For details on setting the time see Time time and date on page 148 BG meter If you have taken a BG meter reading using your compatible Bayer meter readings or manually entered a BG meter reading within the last 12 minutes the BG meter reading appears on the Home screen You can enter your BG meter reading manually using the Event Markers feature or when you use the Bolus Wizard
232. ur local representative for assistance Remember your body still needs insulin while your pump is removed It is important that you consult your healthcare professional to determine an alternate method of receiving insulin while your pump is removed Alarms An alarm warns you that the pump detected Insulin flow something that prevents insulin from being blocked delivered It is important that you respond to an 00 00 alarm Fill Tubing stopped Remove reservoir and WARNING Do not ignore your pump select Rewind to restart when it has an alarm because all insulin delivery is stopped which may lead to high blood glucose and ketoacidosis When an alarm occurs 200 Chapter 12 MP6025957 024 A Display The pump displays a notification with a red icon and instructions Notification light The red notification light blinks twice followed by a pause in a continuous repeating pattern The notification light is shown in Using the buttons on page 20 Audio Depending on your Audio Options settings the pump emits an alarm tone a continuous three pulse and pause vibration pattern or both the alarm tone and vibration You must resolve the underlying problem that triggered the alarm In most cases you clear an alarm by pressing v and then you make a selection In some cases however clearing the alarm does not fix the underlying problem The alarm repeats until the underlying problem is fixed If you do not respond to an alar
233. urning off Sensor Settings You can turn off Sensor Settings at any time If you disconnect the transmitter from the sensor turn off the Sensor Settings to avoid getting a sensor alert Your sensor settings remain in your pump You cannot make changes to the settings until you turn on the Sensor Settings again To turn off Sensor Settings 1 Go to the Sensor Settings screen Menu Sensor Settings 2 Select Sensor 3 Select Yes to turn off the sensor feature 188 Chapter 10 using continuous glucose monitoring MP6025957 024 A MP6025957 024 A Using continuous glucose monitoring This chapter provides information on how to use CGM on your pump and view your sensor glucose data This information helps you identify sensor glucose trends including being notified if your sensor glucose is falling or rising rapidly You can also view historical sensor glucose readings in a graph format Information is also included on how to silence your glucose alerts The sensor graph The sensor graph displays your current sensor glucose SG reading that is wirelessly sent to your pump by the transmitter SmartGuard suspend by sensor high limit SG values low limit 6 continuous VL bolus marker Bio mmol SD SG reading selected reading or event The sensor graph includes the following information e The most recent sensor glucose reading Using continuous glucose monitoring 191 E a A le 5 5 le
234. us Wizard The Bolus Wizard is a feature that uses your individual Bolus Wizard settings to calculate an estimated bolus amount based on the BG values and carbs that you enter Work with your healthcare professional to define your personal settings which include your carb or exchange ratio insulin sensitivity BG target range and active insulin time Note If you do not know how to count carbs consult with your healthcare professional before using the Bolus Wizard After you set up the Bolus Wizard you can use it to calculate and deliver a food bolus a correction bolus or a food plus correction bolus using a Normal bolus see page 74 Square Wave bolus see page 77 or Dual Wave bolus see page 80 Always remember these two things when you are using the Bolus Wizard e Never give a bolus that was calculated more than 12 minutes ago That bolus amount was based on a BG value that is no longer current Instead take a new BG meter test and have the Bolus Wizard re calculate the necessary bolus amount When using the Bolus Wizard promptly respond any message displayed on the pump screen Your prompt response is needed to complete the task The following sections describe how to set up the Bolus Wizard Bolus delivery instructions are provided in the individual sections for each bolus type Understanding your Bolus Wizard settings Your pump guides you through entering the following settings when you first turn on the Bolus W
235. use such as cell phones cordless phones and wireless networks they may prevent communication between the transmitter and the insulin pump This interference does not cause Before you begin 11 O 1 lt O c MP6025957 024 A any incorrect data to be sent and does not cause any harm to your devices Moving away from or turning off these other devices may enable communication If you continue to experience RF interference please contact your local representative AN Caution Changes or modifications to the internal RF transmitter or antenna not expressly approved by Medtronic could void the user s authority to operate this insulin delivery system Directive 1999 5 EC Medtronic declares that this product is in conformity with the essential requirements of Directive 1999 5 EC on Radio and Telecommunications Terminal Equipment For additional information contact Medtronic MiniMed at the address or phone number provided on the back cover For Canada only This device complies with Industry Canada licence exempt RSS standard s Operation is subject to the following two conditions 1 this device may not cause interference and 2 this device must accept any interference including interference that may cause undesired operation of the device Le pr sent appareil est conforme aux CNR d Industrie Canada applicables aux appareils radio exempts de licence L exploitation est autoris e aux deux
236. use this meter to upload system data to your diabetes management software using the USB port on your computer For more details see your meter user guide Note Ihe compatible Bayer meter may not be available in all countries Guardian 2 Link transmitter MMT 7731 used with your pump for Continuous Glucose Monitoring CGM A device that connects to a glucose sensor The transmitter collects data measured by the sensor and wirelessly sends this data to monitoring devices Enlite glucose sensor MMT 7008 used with your pump for CGM The small part of the continuous glucose monitoring system that you insert just below your skin to measure glucose levels in your interstitial fluid The sensor Is a single use device CareLink USB MMT 7306 used to upload system data to the diabetes management software using a USB port on your computer Chapter 1 MP6025957 024 A Accessories The following accessories may be used with your MiniMed 640G system Belt clip ACC 1599 used to wear the pump on your belt Also you can use the tip of the belt clip to open the battery compartment on your pump Activity guard ACC 1520 used if you are active in sports or if a child is wearing the pump Using the activity guard prevents the reservoir from being rotated or removed from the pump Skins used to personalize the look of your pump Skins are decorative overlays Your pump is designed to have skins attached to the back of the pu
237. ust re enter your settings to continue using your pump The Clear All Settings feature does not delete wireless connections to other devices such as your transmitter or compatible Bayer meter AN Caution Do not clear the settings on the pump unless directed by your healthcare professional If you clear your settings you must re enter all your personal settings as directed by your healthcare professional General settings 143 D 5 b 28 un et ET 2 N MP6025957 024 A To clear all your settings ls 2 Make sure the pump is not connected to your body Go to the Manage Settings screen Menu gt Utilities gt Manage Settings Simultaneously press and hold gt and until the Manage Settings menu appears Select Clear All Settings A confirmation screen appears asking if you want to clear all your settings To continue clearing your settings select Yes If you do not want to clear your settings select No If you clear your settings your pump displays the Welcome screen and continues to the Startup Wizard For more details on entering your startup settings see Entering your startup settings on page 24 Clearing your active insulin Use this feature when you are ready to use your pump with insulin for the first time This feature clears any active insulin values that your pump has tracked and sets the active insulin value to zero If you have practiced delivering a bolus with your
238. y your healthcare professional 4 Note If you are setting your max basal rate after you have set up your basal patterns or preset temp basal rates you cannot set your max basal rate lower than any of your existing basal rates You cannot access this feature during a bolus delivery To set your Max Basal Rate 1 Go to the Max Basal Bolus screen Menu Insulin Settings Max Basal Bolus 2 Select Max Basal to set the maximum number of basal insulin units that can be delivered each hour Because the Max Basal Rate setting determines your basal insulin limits a warning message appears any time you enter the screen to change the value To continue setting the value select Continue 3 n the Max Basal Rate screen select Max Basal to set the maximum units per hour 4 Select Save Basal patterns Your basal pattern determines the amount of basal insulin you receive throughout the day and night Because your basal insulin needs can vary you can set up to eight basal patterns For example you might use one basal pattern during the week and a different basal pattern during the weekend Basal 41 MP6025957 024 A A basal pattern is made up of one to 48 basal rates that you set up to cover a full 24 hour period If you only need one basal rate throughout the day you set only one rate for the 24 hour period If you need the basal rates to change during the day or night to better match your insulin needs you can set more tha

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