Medtronic MiniMed 1510 620G/630G/640G/670G Insulin Delivery Pump User Manual 5

Medtronic MiniMed, Inc. 620G/630G/640G/670G Insulin Delivery Pump Users Manual 5

Users Manual 5

WARNING: If you receive a critical error on your pump, thefollowing screen displays and the pump sirens.Immediately disconnect from your insulin pump and discontinueuse. Contact your local representative for assistance.Remember, your body still needs insulin while your pump isremoved. It is important that you consult your healthcareprofessional to determine an alternate method of receiving insulinwhile your pump is removed.AlarmsAn alarm warns you that the pump detectedsomething that prevents insulin from beingdelivered. It is important that you respond to analarm.WARNING: Do not ignore your pumpwhen it has an alarm because allinsulin delivery is stopped, which maylead to high blood glucose andketoacidosis.When an alarm occurs: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 acontinuous repeating pattern. The notification light is shown in Using the buttons,on page 20.200 Chapter 12MP6025958-022 / ARELEASED
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 andvibration.You must resolve the underlying problem that triggered the alarm. In most cases,you clear an alarm by pressing and then you make a selection. In some cases,however, clearing the alarm does not fix the underlying problem. The alarmrepeats until the underlying problem is fixed.If you do not respond to an alarm, after ten minutes the alarm tone escalates to aloud emergency siren. For more information, see Alarm and alert escalation, onpage 247.AlertsAn alert makes you aware of a situation that mayrequire your attention. An alert is less serious thanan alarm.When an alert occurs:Display: The pump displays a notification with ayellow icon and instructions.Notification light: The red notification light on your pump blinks once, followedby a pause, then blinks once again in a continuous repeating pattern. Thenotification light is shown in Using the buttons, on page 20. Audio: Depending on your Audio Options settings, the pump either beeps orvibrates in a continuous three-pulse-and-pause pattern, or does both.To clear an alert, press and then make a selection. If you do not respond to analert, the pump beeps every five minutes or every fifteen minutes, depending onthe alert. Some alerts will also escalate to a loud emergency siren after tenminutes. For more information, see Alarm and alert escalation, on page 247.Note: If an alert occurs when you are in a screen other than the Homescreen, the alert message may appear after you return to the Homescreen. ■ alarms, alerts, and messages Alarms, alerts, and messages 201MP6025958-022 / ARELEASED
MessagesA message informs you about the status of yourpump or if you need to make a decision.When a message occurs:Display: The pump displays a notification with ablue icon and instructions.Notification light: Does not illuminate or blink.Audio: Depending on the message, the pump emits a message tone, an alerttone, 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 and make a selection.Pump alarms, alerts, and messagesThe following table lists the most common or serious alarms, alerts, and messagesrelated to your pump. The table also explains the meaning, consequences, and thereasons why these notifications appear, and provides steps for problem resolution.Title and text Explanation Next stepsActive Insulin clearedAny Active Insulin amounthas been cleared.An alarm hascleared your activeinsulin amount.Your active insulinamount is now at0 units.• Select OK to clear the alarm.• The active insulin tracked prior topump restart is not included innew Bolus Wizard calculations.Consult your healthcareprofessional for how long youneed to wait after active insulin iscleared before you can rely onthe active insulin calculation ofyour Bolus Wizard• You can check Daily History forthe time and amount of your lastbolus. For more information, seeDaily History, on page 121.202 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsAuto SuspendInsulin deliverysuspended. No buttonspressed within time set inAuto Suspend.You have notpressed any buttonsduring the timespecified in theAuto Suspendsettings.• To clear the alarm and resumebasal insulin delivery, selectResume Basal.• Check your BG and treat asnecessary.Battery failedInsert a new AA battery.The pump batterydoes not haveenough power.• Select OK to clear the alarm.• Remove the old battery andinsert a new AA battery.For details, see About batteries, onpage 21.Battery not compatible.See User Guide.The battery that youinserted into thepump is notcompatible.• To clear the alarm, remove theincompatible battery.• Insert a new AA battery. Forcompatible battery types, seeAbout batteries, on page 21.Bolus not delivered.Bolus entry timed outbefore delivery. If bolusintended, enter valuesagain.Bolus valuesentered, but boluswas not deliveredwithin 30 seconds.• Select OK to clear the alert.• If bolus delivery was intended,check your BG, re-enter bolusvalues and deliver bolus.Bolus stoppedCannot resume bolus orcannula fill. XX.XXX ofYY.YYY U delivered.ZZ.ZZZ U not delivered. Ifneeded, enter valuesagain.The battery powerwas exhaustedwhile a bolus or FillCannula was inprogress.• Note the amount of insulin notdelivered.• Replace the AA battery.• Select OK to clear the alarm.• Deliver the remaining bolusamount if needed.■ alarms, alerts, and messages Alarms, alerts, and messages 203MP6025958-022 / ARELEASED
Title and text Explanation Next stepsCannot connect deviceThis device isincompatible with yourpump. See User Guide.• You may be tryingto connect adevice that is notcompatible withyour pump.• You are trying toconnect atransmitter to yourpump but anothertransmitter isalready wirelesslyconnected to yourpump.• Select OK to clear the alert.• Check the list of devices that arecompatible with your pump inOptional devices, on page 14.• If you are replacing yourtransmitter, make sure that youfirst delete the old transmitterfrom your pump before you tryto connect your new transmitter.Only one transmitter can beconnected to your pump. Fordetails, see Deleting thetransmitter from your pump, onpage 181.Check settingsStartup Wizard settingscomplete. Check and setup your other settings.Some settings havebeen cleared orreverted to factorydefault values.• Select OK to clear the alert.• Review any settings that youhave not already set in StartupWizard and re-enter the values, ifnecessary.Critical pump errorDelivery stopped. Pumpnot working properly.Stop using pump.Remove infusion set frombody. Consider otherinsulin treatment. SeeUser Guide.Your pump hasencountered acritical error.The pump is not able to deliverinsulin. Remove your infusion setand stop using your pump.• Consider another form of insulindelivery.• Check your BG, and treat asnecessary.• Write down the error code thatappears on the alarm screen.• Call your local representative forassistance with your pump.204 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsDelivery limit exceededDelivery stopped. CheckBG. See User Guide formore information.You have attemptedto deliver moreinsulin thanexpected based onyour Max Bolus andMax Basal settings.• Check your BG.• Select Resume Basal.• Check Bolus History andreevaluate your need for insulin.• Continue to monitor your BG.Fill Cannula?Select Fill to fill cannulaor select Done if notneeded.You had the FillCannula screendisplayed for15 minutes.• To proceed and fill the cannula,select Fill.• If you do not need to fill thecannula, select Done to skip thisprocess.Insert batteryDelivery stopped. Insert anew battery now.The battery wasremoved from thepump.• Insert a new AA battery.• The alarm clears when you inserta new battery.• The pump powers off after10 minutes unless you insert anew battery.■ alarms, alerts, and messages Alarms, alerts, and messages 205MP6025958-022 / ARELEASED
Title and text Explanation Next stepsInsulin flow blockedCheck BG. Considerinjection and testingketones. Change reservoirand infusion set.Your pump hasdetected that thebasal or bolusinsulin flow wasblocked.• Check your blood glucose.Consider checking ketones andtake an injection if needed.• Remove your infusion set andreservoir.• Select Rewind to start the newreservoir process using a newinfusion set and reservoir.If a bolus delivery was in progresswhen the alarm occurred:• Check the Daily History screen forthe amount of bolus alreadydelivered before the pumpalarmed.• Consider delivering remainingbolus, if the bolus insulin was notincluded in an insulin injection.206 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsInsulin flow blockedCheck BG. Considerinjection and testingketones. Estimated 0 Uinsulin in reservoir.Change reservoir andinfusion set.Your pump hasdetected that theinsulin flow wasblocked and there isno insulin in thereservoir.• Check your blood glucose.Consider checking ketones andtake an injection if needed.• Remove your infusion set andreservoir.• Select Rewind to start the newreservoir process using a newinfusion set and reservoir.If a bolus delivery was in progresswhen the alarm occurred:• Check the Daily History screen forthe amount of bolus alreadydelivered before the pumpalarmed.• Consider delivering remainingbolus, if the bolus insulin was notincluded in an insulin injection.■ alarms, alerts, and messages Alarms, alerts, and messages 207MP6025958-022 / ARELEASED
Title and text Explanation Next stepsInsulin flow blockedFill Cannula stopped.Remove infusion set frombody. Change reservoirand infusion set.Your pump hasdetected the insulinflow was blockedwhile filling thecannula.• Check your blood glucose.Consider checking ketones andtake an injection if needed.• Remove your infusion set andreservoir.• Select Rewind to start the newreservoir process using a newinfusion set and reservoir.If a fill cannula was in progresswhen the alarm occurred:• Check the Daily History screen forthe amount of bolus alreadydelivered before the pumpalarmed.• Consider delivering remainingbolus, if the bolus insulin was notincluded in an insulin injection.208 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsInsulin flow blockedFill Tubing stopped.Remove reservoir andselect Rewind to restart.Your pump hasdetected the insulinflow was blockedwhile filling thetubing. Possibleconnection issuebetween the tubingand reservoir.• Remove the reservoir and selectRewind to restart the fill tubingprocess.• Disconnect tubing from reservoir.• Be sure tubing is not crimped orbent.•Continue following the stepsdisplayed on the pump using thesame infusion set and reservoir.• If this alarm occurs again, use anew infusion set.If a fill tubing delivery was inprogress when the alarm occurred:• Check the Daily History screen forthe amount of bolus alreadydelivered before the pumpalarmed.• Consider delivering remainingbolus, if the bolus insulin was notincluded in an insulin injection.Loading incompleteRemove reservoir andselect Rewind to restartloading.You pressed after loading began.• Remove the reservoir to startagain.• Select Rewind and follow the on-screen instructions.Low battery PumpReplace battery soon.The battery in thepump is low onpower.• Select OK to clear the alert.• Replace the AA battery as soonas possible. Otherwise, insulindelivery stops, and the ReplaceBattery Now alarm occurs.•If the pump is delivering a bolusor filling the cannula, wait untildelivery is complete to replacebattery.■ alarms, alerts, and messages Alarms, alerts, and messages 209MP6025958-022 / ARELEASED
Title and text Explanation Next stepsLow reservoirXX hours remaining.Change reservoir.or:XX units remaining.Change reservoir.Your reservoir is lowon insulin,according to thenumber of hours orunits set in the LowReservoir Reminder.• Select OK to clear the alert.• Change the reservoir soon.• If you do not change thereservoir after you receive thisalert, you will receive a secondLow reservoir alert when theinsulin level reaches half of youroriginal alert amount. For moredetails, see Low Reservoirreminder, on page 132.Manage settings errorDelivery stopped. Backupsettings cleared fromManage Settings. Currentsettings are workingproperly. Select OK torestart. See User Guide.A pump error hasoccurred, and youneed to restart yourpump. Your backupsettings have beenlost, but yourcurrent settings areunchanged.• Select OK to restart your pump.Your current settings areunchanged. Only your backupsettings are lost.• When the pump restarts, followinstructions on the pump display.•If the pump was delivering abolus or filling the cannula, checkDaily History and evaluate yourneed for insulin.• Consider saving your currentsettings. For details, see Savingyour settings, on page 142.Max Fill reached3X.X U. Did you see dropsat the end of tubing?You have exceededthe number of unitsexpected to fill thetubing. By now,insulin should be atthe end of thetubing.• If you see drops at the end ofthe tubing, select Yes.• If you do not see drops, selectNo.• Follow instructions displayed onthe pump.210 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsMax Fill reached4X.X U. Remove reservoirand select Rewind torestart New Reservoirprocedure.You have exceededthe number of unitsexpected to fill thetubing. By now,insulin should be atthe end of thetubing.• Remove the reservoir.• Check if you still have insulin inthe reservoir. If you do, you cancontinue using the samereservoir.• Select Rewind to restart the newreservoir procedure.No reservoir detectedRewind before loadingreservoir.There is no reservoirin the pump or thereservoir is notproperly locked intoplace.• Select Rewind.• Ensure that your reservoir is filledwith insulin.• When prompted, ensure thatyour reservoir is inserted andproperly locked into place.Power error detectedDelivery stopped. Recordyour settings byuploading to CareLink orwrite your settings onpaper. See User Guide.The internal powersource in yourpump is unable tocharge. Your pumpis operating on theAA battery only.• Select OK to clear the alert.• Check your BG and treat asnecessary.• Record your settings as soon aspossible because your AA batterymay not last long.• Call your local representative forassistance with your pump.Power lossAA battery was removedfor more than 10 min orpower was lost. Select OKto re-enter time and date.Your pump batteryhas been out formore thanten minutes, andyour pump has lostpower. You mustreset your time anddate.• Select OK to go to the Time &Date screen.• Enter the current time, timeformat, and date.■ alarms, alerts, and messages Alarms, alerts, and messages 211MP6025958-022 / ARELEASED
Title and text Explanation Next stepsPump errorDelivery stopped. Currentsettings cleared. Pumprestart needed. Select OKto restart and then re-enter your settings. SeeUser Guide.Your pumpencountered anerror and willrestart. Your pumpsettings will returnto factory defaultvalues.• When the pump restarts, followinstructions on the pump display.• After restart, check settings andre-enter values as needed.• If you recently saved backupsettings in Manage Settings, useRestore Settings.•If the pump was delivering abolus or filling the cannula, checkDaily History and reevaluate yourneed for insulin.• If this alarm recurs frequently,write down the error codedisplayed on the alarm screen(you can also find it in yourAlarm History) and contact yourlocal representative for assistancewith your pump.Pump errorDelivery stopped. Settingsunchanged. Pump restartneeded. Select OK torestart. See User Guide.A pump error hasoccurred, you needto restart yourpump.• Select OK to restart your pump.•If the pump was delivering abolus or filling the cannula, checkDaily History and reevaluate yourneed for insulin.• If this alarm recurs frequently,write down the error codedisplayed on the alarm screen(you can also find it in yourAlarm History) and contact yourlocal representative for assistancewith your pump.212 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsPump errorDelivery stopped. Settingsunchanged. Select OK tocontinue. See User Guide.Your pumpencountered anerror but a restart isnot necessary. Theissue is resolved.Your settings arenot changed.• Select OK to resume basaldelivery.•If the pump was delivering abolus or filling the cannula, checkDaily History and reevaluate yourneed for insulin.• If this alarm recurs frequently,write down the error codedisplayed on the alarm screen(you can also find it in yourAlarm History) and contact yourlocal representative for assistancewith your pump.Pump restartedDelivery stopped. Settingsunchanged. Select OK tocontinue. See User Guide.Your pump hasencountered aproblem and hasrestarted. Yoursettings have notbeen changed.• Select OK to continue.•If the pump was delivering abolus or filling the cannula, checkDaily History and re-evaluate yourneed for insulin.• If this alarm recurs frequently,write down the error codedisplayed on the alarm screen(you can also find it in yourAlarm History) and contact yourlocal representative for assistancewith your pump.Replace batteryBattery life less than 30minutes. To ensure insulindelivery, replace batterynow.Battery life is lowand will beexhausted within 30minutes.• Select OK to clear the alert.• Replace the AA battery.■ alarms, alerts, and messages Alarms, alerts, and messages 213MP6025958-022 / ARELEASED
Title and text Explanation Next stepsReplace battery nowDelivery stopped. Batterymust be replaced toresume delivery.Insulin delivery hasstopped due to lowpower. Battery wasnot replaced afterthe Low batteryPump alert.Replace the battery immediately toresume insulin delivery. For details,see Removing the battery, onpage 23.Reservoir estimate at 0 UTo ensure insulin delivery,change reservoir.Your reservoir levelis estimated at0 units.• Select OK to clear the alert.• Change the reservoir now.Resume bolus?XXX of YYY U delivered.Resume delivery ofZZZ U?A normal bolusdelivery has beeninterrupted becausethe pump batterywas removed. If it iswithin 10 minutessince thisinterruption, youcan resume thisbolus.• Check the message to see howmuch of the bolus was actuallydelivered.• To cancel remaining amount ofbolus, select Cancel.• To resume remaining amount ofbolus, select Resume.Resume Dual bolus?XX of YY U delivered.Resume delivery of ZZ Ufor XX:XX hr?The Square portionof Dual Bolusdelivery has beeninterrupted. If it iswithin 10 minutessince thisinterruption, youcan resume thisbolus.• Check the message to see howmuch of the Dual Wave boluswas actually delivered.• To cancel remaining amount ofbolus, select Cancel.• To resume remaining amount ofbolus, select Resume.214 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsResume Dual bolus?XX of YY U delivered.Resume delivery of ZZ Unow, and AA U Square forXX:XX hr?The Now portion ofa Dual Wave bolusdelivery has beeninterrupted becausethe pump batterywas removed. If it iswithin 10 minutessince thisinterruption, youcan resume thisbolus.• Check the message to see howmuch of the Dual Wave boluswas actually delivered.• To cancel remaining amount ofbolus, select Cancel.• To resume remaining amount ofbolus, select Resume.Resume Square bolus?XX of YY U delivered forXX:XX hr. Resume deliveryof ZZ U for XX:XX hr?The Square Wavebolus delivery wasinterrupted. If it iswithin 10 minutessince thisinterruption, youcan resume thisbolus.• Check the message to see howmuch of the Square Wave boluswas actually delivered.• To cancel remaining amount ofbolus, select Cancel.• To resume remaining amount ofbolus, select Resume.Stuck buttonButton pressed for morethan 3 minutesThe pump hasdetected that abutton has beenpressed for anunusually long time.• Select OK to clear the alarm.• If this alarm occurs again, contactyour local representative forassistance with your pump.If you are unable to clear thealarm:• Consider another form of insulin,because your pump is notdelivering insulin.• Check your BG and treat asnecessary.• Contact your local representativefor assistance with your pump.■ alarms, alerts, and messages Alarms, alerts, and messages 215MP6025958-022 / ARELEASED
Title and text Explanation Next stepsWrong key pressedTry againWrong buttonselected whileunlocking thepump.• Select OK to clear the alert.• Try to unlock the pump. Selectthe highlighted key whenprompted.For more information, seeUnlocking your pump, on page 26. CGM (sensor) alarms, alerts, and messagesThe following table lists the most common or serious alarms, alerts, and messagesrelated to your sensor glucose readings, as well as the status of your transmitterand sensor. The table also explains the meaning, consequences, and the reasonswhy these notifications appear, and provides steps for problem resolution.Title and text Explanation Next stepsAlert before highSensor glucoseapproaching High Limit.Check BG.Your SG value isapproaching yourspecified high limit.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Alert before lowSensor glucoseapproaching Low Limit.Check BG.Your SG value isapproaching yourspecified low limit.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Alert on high XXX mg/dLHigh sensor glucose.Check BG.Your SG value is ator above yourspecified high limit.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.216 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsAlert on low XXX mg/dLLow sensor glucose.Check BG.Your SG value is ator below yourspecified low limit.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Alert on low XXX mg/dLLow sensor glucose.Insulin delivery suspendedsince XX:XX. Check BG.Your SG value is ator below yourspecified low limit,and the pump hassuspended insulindelivery due to aSuspend on low orSuspend before lowevent.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Basal delivery resumedBasal delivery resumed atXX:XX after suspend bysensor. Check BG.Your pump isresuming basalinsulin delivery aftera Suspend on lowor Suspend beforelow event occurred.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Basal delivery resumedLow settings changecaused basal to beresumed at XX:XX. CheckBG.Your pump isresuming basalinsulin delivery aftera Suspend beforelow or a Suspendon low eventoccurred, becauseyou have turned offthe Suspend beforelow or the Suspendon low feature.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.■ alarms, alerts, and messages Alarms, alerts, and messages 217MP6025958-022 / ARELEASED
Title and text Explanation Next stepsBasal delivery resumedMaximum 2 hour suspendtime reached. Check BG.Your pump isresuming basalinsulin delivery twohours after aSuspend before lowor Suspend on lowevent occurred.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.Basal delivery resumedMaximum 2 hour suspendtime reached. SG is stillunder Low limit. CheckBG.Your pump isresuming basalinsulin delivery twohours after aSuspend before lowor Suspend on lowevent occurred.• Your pump has resumed basalinsulin delivery; however, your SGvalue is still at or below your lowlimit.• Select OK to clear the alert.• Check your BG.• Follow instructions from yourhealthcare professional andcontinue to monitor your BG.BG not receivedPlace pump close totransmitter. Select OK toresend BG to transmitter.The transmitter wasunable to receivethe calibration BGmeter readings fromthe pump.• Move your pump and transmittercloser together.• Select OK. Your pump tries againto send your BG to yourtransmitter for sensor calibration.218 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsCalibrate nowCheck BG and calibratesensor.A BG meter readingis neededimmediately tocalibrate yoursensor so that youcan continuereceiving sensorglucose readings.• Take a BG meter reading andenter for calibration. After youreceive a Calibrate now alert, ittakes up to 15 minutes after youcalibrate for your pump toreceive SG values. For details, seeCalibrating your sensor, onpage 183.• If you are unable to calibratenow, you can use the Snoozefeature. Set the desired time, andselect Snooze. If you do notcalibrate before the Snooze timeis up, the Calibrate Now alertoccurs again.Calibration not acceptedRecheck BG and calibratesensor.Your system wasunable to use theBG meter readingsyou entered tocalibrate yoursensor.• Wash and dry hands thoroughly.See Guidelines for calibrating, onpage 186.• Enter a new BG meter reading forcalibration as instructed inCalibrating your sensor, onpage 183. If you receive aCalibration not accepted alert onyour second calibration, aChange sensor alert occurs.• Call your local representative ifyou have questions.■ alarms, alerts, and messages Alarms, alerts, and messages 219MP6025958-022 / ARELEASED
Title and text Explanation Next stepsCannot find sensorsignalDisconnect and reconnecttransmitter, then selectOK. Notice if transmitterlight blinks.The pump has notreceived a signalfrom thetransmitter.• Disconnect and reconnect yourtransmitter and sensor.• See if the light on yourtransmitter blinks whenconnected to the sensor. Youmay need this information fortroubleshooting later.• Select OK. Your pump searchesfor your sensor. If your pumpreceives a signal from yoursensor, you do not need to doanything else. If your pump doesnot receive a signal from thesensor, another message appearsto let you know.Change sensorInsert new sensor andStart New Sensor.You selected No inthe Check sensorinsertion message,indicating that yoursensor is not fullyinserted.• Select OK to clear the alert.• Change your sensor. For details,see your sensor user guide.• After you change your sensor,refer to Starting the sensor, onpage 182.Change sensorSecond calibration notaccepted. Insert newsensor.This alert occurswhen you receivetwo Calibration notaccepted errors in arow.• Select OK to clear the alert.• Change your sensor. For details,see your sensor user guide.Change sensorSensor not workingproperly. Insert newsensor.Sensor signal is nolonger reliable.• Select OK to clear the alert.• Change your sensor. For details,see your sensor user guide.220 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsCheck connectionEnsure transmitter andsensor connection issecure, then select OK.The pump fails todetect thetransmitter and isunable to receivesensor signal.• Select OK to clear the alert.• If your sensor is fully inserted,select Yes. If your sensor is notfully inserted, select No.• If your sensor was not fullyinserted, insert a new sensor.• If you still cannot connect yoursensor, see My pump cannot findthe sensor signal, on page 234.Lost sensor signalMove Pump closer totransmitter. May take15 minutes to find signal.Transmitter signalhas not beenreceived for30 minutes duringor after initialization.• Move your pump closer to yourtransmitter. It can take up to15 minutes for your pump tostart communicating with yourtransmitter.• Select OK to clear the alert.Low battery transmitterRecharge transmitterwithin 24 hours.The battery in thetransmitter needs tobe recharged within24 hours.• Select OK to clear the alert.• Recharge your transmitter assoon as possible.Medical deviceCALL FOR EMERGENCYASSISTANCE. I havediabetes.Your pump issuspended due tolow SG, and youhave not respondedto the alarm within10 minutes.• Select Dismiss.• Immediately call for emergencyassistance.■ alarms, alerts, and messages Alarms, alerts, and messages 221MP6025958-022 / ARELEASED
Title and text Explanation Next stepsNo calibration occurredConfirm sensor signal.Calibrate by XX:XX.The transmitter wasunable to receivethe calibration BGmeter readings fromthe pump.• Select OK to clear the alert.• Check the status bar on yourpump to ensure that your pumphas a signal from your sensor. Ifthere is no sensor signal, see Mypump cannot find the sensorsignal, on page 234.• Calibrate again by the timeshown on the pump screen toensure you continue SGmonitoring.No calibration occurredConfirm sensor signal.Check BG again tocalibrate sensor.The transmitter wasunable to receivethe requiredcalibration BG fromthe pump.Calibration isrequired by thesystem for SGvalues to resume."Calibrationrequired" appearson your sensorgraph.• Select OK to clear the alert.• Take another BG meter readingand calibrate again.Possible signalinterferenceMove away fromelectronic devices. Maytake 15 minutes to findsignal.There may beinterference fromanother electronicdevice that isaffecting thecommunicationbetween yourpump andtransmitter.• Move away from other electronicdevices. It can take up to15 minutes for your pump tostart communicating with yourtransmitter.• Select OK to clear the alert.222 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsRise AlertSensor glucose risingrapidly.Your SG value hasbeen rising as fastor faster than yourpreset Rise AlertLimit.• Select OK to clear the alert.• Monitor trend and glucose level.• Follow instructions from yourhealthcare professional.Sensor alert occurredCheck Alarm History forsilenced alerts.Sensor alertoccurred when AlertSilence is on.• Select OK to clear the alert.• Check the Alarm History screento see which alerts were silenced.For more information aboutaccessing the Alarm Historyscreen, see Alarm History, onpage 122.• Select the alert to open theAlarm Detail screen.• Take action based on theselected alert.Sensor connectedIf new sensor, select StartNew. If not, selectReconnect.The transmitter hasdetected that youhave connected asensor. The pumpneeds to know ifthis is a new sensoror if you havereconnected yourold sensor.• If you have connected a newsensor, select Start New Sensor.• If you have reconnected a sensoryou have been using, selectReconnect Sensor.• In either case, a "warm-up"messages appears on your Homescreen, and you are prompted tocalibrate your sensor. Your pumpstarts receiving your SG valuesagain after the two-hourinitialization is complete.Sensor expiredInsert new sensor.The sensor hasbeen used for6 days (144 hours).It has reached theend of its useful life.Change your sensor. For details,see your sensor user guide.■ alarms, alerts, and messages Alarms, alerts, and messages 223MP6025958-022 / ARELEASED
Title and text Explanation Next stepsSensor signal not foundDid transmitter light blinkwhen connected tosensor?The pump has stillnot received asignal from thetransmitter.When you reconnected thetransmitter to the sensor, did yousee a blinking green light on thetransmitter?• Select Yes or No and follow theinstructions on the screen.Sensor signal not foundSee User Guide.After multipleattempts, the pumpfailed to detect thetransmitter and isunable to receivesensor signal.• Select OK to clear the alert.• Repeat the connection process.Remove the transmitter from thesensor for about ten seconds,and then reconnect it to thesensor.• It can take up to 15 minutes foryour pump to find the sensorsignal.• Move your pump closer to yourtransmitter to improve reception.• Make sure you are away fromany electronic devices that mightcause interference, such ascellular phones and otherwireless devices.• If your pump still cannot find thesensor signal, call your localrepresentative for assistance.SG value not availableIf problem continues, seeUser Guide.The sensor signalsare either too highor too low.• Select OK to clear the alert.• You do not need to change thesensor. If the alert persists, testyour transmitter with the tester.Refer to your transmitter userguide for instructions on testingthe transmitter.224 Chapter 12MP6025958-022 / ARELEASED
Title and text Explanation Next stepsSuspend before lowDelivery stopped. Sensorglucose approaching LowLimit. Check BG.Your SG value isfalling. Insulindelivery issuspendedaccording to yourSuspend before lowsetting and your SGis approaching yourspecified low limit.• Select OK to clear the alert.• Check your BG. If necessary, treatyour BG as directed by yourhealthcare professional.Suspend on lowDelivery stopped. Sensorglucose XXX mg/dL.Check BG.Your SG value is ator below the lowlimit you specified.• Select OK to clear the alert.• Check your BG. If necessary, treatyour BG as directed by yourhealthcare professional.Transmitter batterydepletedRecharge transmitter now.The battery in thetransmitter needs tobe recharged. SGvalues are notrecorded ortransmitted untilyou rechargetransmitter.• Select OK to clear the alert.• Recharge your transmitter. CareLink alert and messageThe following table lists the most common or serious alarms, alerts, and messagesrelated to CareLink. The table also explains the meaning, consequences, and thereasons why these notifications appear, and provides steps for problem resolution.■ alarms, alerts, and messages Alarms, alerts, and messages 225MP6025958-022 / ARELEASED
Title and text Explanation Next stepsConnect Device?Device with SN<XXXXXXXXXX> is tryingto connect to your pump.Allow connection?The CareLink USBsoftware isattempting toconnect to yourpump inpreparation for datadownload.• Select Yes to allow connection,only if you are expecting orperforming a data download.• Select No to deny connection.If no selection is made, thescreen will timeout after 30seconds and will automaticallyreject the request.Download slowInsulin delivery notaffected. CareLinkdownload may takelonger than usual. SelectOK to continue. See UserGuide.The download ofpump data is takinglonger thanexpected. Data willnot be affected.• Select OK to clear the alert.• Wait for the data to finishdownloading.• If problem still persists or if thereis no progress in download, callyour local representative forassistance. 226 Chapter 12MP6025958-022 / ARELEASED
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TroubleshootingThis chapter contains procedures and information to help you understand andaddress conditions that might occur with your pump.For a list of alarms, alerts, and messages that may appear on your pump, see Pumpalarms, alerts, and messages, on page 202.Troubleshooting pump issuesWARNING: If you receive a critical error on your pump, thefollowing screen displays and the pump sirens.Immediately disconnect from your insulin pump and discontinueuse. Contact your local representative for assistance.Remember, your body still needs insulin while your pump isremoved. It is important that you consult your healthcareprofessional to determine an alternate method of receiving insulinwhile your pump is removed. Troubleshooting 229■ troubleshootingMP6025958-022 / ARELEASED
What is a Check Settings alarm?This alarm occurs when a condition causes your pump to reset to factory settings.You see this alarm after your pump guides you through re-entering the StartupWizard settings.The Check Settings alarm is letting you know that other settings may have beencleared or reverted to factory default values. Review any settings that you have notalready set in Startup Wizard and re-enter the values, if necessary.My pump is asking me to rewindWARNING: Make sure the infusion set is disconnected from yourbody before you rewind your pump or fill the infusion set tubing.Never insert the reservoir into the pump while the tubing isconnected to your body. Doing so could result in an accidentalinfusion of insulin, which may cause low BG.You always rewind your pump when changing the reservoir. Rewinding returns thepiston in the reservoir compartment to its starting position. It is normal for yourpump 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 problemloading the reservoir.I dropped my pumpCaution: If your pump has been dropped or you suspect your pumpis damaged, carefully inspect your pump to ensure there are no cracksbefore 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 tubing for cracksor damage.4. Review the status screen, basal rates and other pump settings.5. Perform the Self Test procedure by going to:230 Chapter 13MP6025958-022 / ARELEASED
Menu > Utilities > Self TestFor details, see Self Test, on page 145.6. If the Self Test does not complete successfully, or if you are concerned aboutyour pump, call your local representative for assistance and check your BG.I cannot get to the Manage Settings screenIf you go to Menu > Utilities > Manage Settings, a message appears telling youthat the feature is not normally accessible and to consult your user guide. Toaccess the Manage Settings screen:1. Menu > Utilities > Manage Settings2. Simultaneously press and hold and for about two seconds. The ManageSettings screen appears. For more information, see Managing your pumpsettings , on page 142.My pump display times out too quicklyYour pump display times out after 15 seconds by default in order to conservebattery power. You can increase this setting up to three minutes. Go to Menu >Utilities > Display Options, and then adjust the Backlight setting as desired. Formore information, see Display Options, on page 141.Note: Be aware that using a longer Backlight time causes your pump touse more battery power. When your pump battery is low, the timeout forthe backlight on your pump screen is automatically reduced. Where is my pump status screen?1. To go to the Status screen, highlight and select the status bar at the top ofyour Home screen.■ troubleshooting Troubleshooting 231MP6025958-022 / ARELEASED
17:00Bolus Basal110mg/dLActive Insulin1.0UBGThe Status screen appears.2. From the Status screen, you can select the type of status information youwant to view. For example, to see a quick status of your pump and recentinsulin deliveries, go to Quick Status. For details, see Status screens, on page 31.My pump is asking me to enter my settingsCertain pump errors can clear your settings and return them to their factorydefault values. This also happens if you intentionally clear your settings. Do notclear your settings unless directed to do so by your healthcare professional.If you have saved your settings using the Save Settings option, you can restorethem using the Restore Settings option. If you restore your settings, ensure therestored settings match the settings prescribed most recently by your healthcareprofessional.The Startup Wizard appears automatically when your pump restarts. The wizardguides you through entering the following information. Be sure to have thesevalues ready when you begin.• Time format, time, and date•Carb unit•Active Insulin Time232 Chapter 13MP6025958-022 / ARELEASED
• Basal patternsAfter you enter your pump settings, you have the option of entering the followingBolus Wizard settings:• Carb ratio or Exchange ratio• Insulin sensitivity factor•BG target To enter your pump settings:1. Begin entering your settings by selecting your language. Click Next to go toeach new screen.2. When the Select Time Format screen appears, select a 12-hour or a 24-hourtime format.3. When the Enter Time screen appears, adjust the setting to the current time. Ifyou 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 thecurrent date.5. When the Select Carb Unit screen appears, select Grams or Exchanges as theunit 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 71.7. Enter your first basal rate by entering the End time and the Rate. You canenter 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 toreview your basal information.8. When the message appears asking if you want to setup the Bolus Wizardsettings, do one of the following:• Select Yes to continue entering your settings, then continue to the nextsection.• Select No if you do not want to enter your Bolus Wizard settings. Amessage appears letting you know that your settings are complete. SelectOK to continue using your pump.■ troubleshooting Troubleshooting 233MP6025958-022 / ARELEASED
 To enter your Bolus Wizard settings:1. When your pump shows a list of settings for the Bolus Wizard, make sure youhave the values you need before continuing.2. Depending on the Carb Unit you set earlier, either the Carb Ratio or the ExchRatio screen appears. Enter your carb ratio or exchange ratio by entering theEnd time and the Rate. You can adjust your carb or exchange ratio at anytime.For details, see Changing your carb or exchange ratio, on page 69.3. When the Edit Sensitivity screen appears, enter your insulin sensitivity factorby entering the End time and the mg/dL per unit. You can adjust your insulinsensitivity factor at any time.For details about entering insulin sensitivity factors, including how to setmultiple time periods, see Changing your insulin sensitivity factor, on page 70.4. When the BG Target screen appears, enter your BG Target range by enteringthe End time and your Lo (low) and Hi (high) limits. You can adjust your BGTarget 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.5. Select Next to display the Home screen, and continue using your pump.Troubleshooting sensor issuesMy pump cannot find the sensor signalIf your pump cannot find the sensor signal after you connect your sensor andtransmitter, follow the instructions on the pump screen to troubleshoot the issueas described below.If your pump finds the sensor signal at any time during troubleshooting, yourpump beeps or vibrates, and "Warm up" appears on your sensor graph. It can takeup to two hours for your sensor to warm up.234 Chapter 13MP6025958-022 / ARELEASED
Note: If you are using Alert Silence and currently have all sensor alertssilenced, your pump does not display the troubleshooting screens. Anyglucose alerts you received are displayed in the Alarm History screen. 1. Make sure your setup meets the following requirements:• Your transmitter is fully charged.If both lights on the charger are off, your transmitter is fully charged. Fordetails, see your transmitter user guide.• You have only one transmitter connected to your pump.Delete the current transmitter that is connected to your pump beforecontinuing. For details, see Deleting the transmitter from your pump, onpage 181.• Your transmitter is placed next to your pump.• Your transmitter is reconnected to the pump, if your pump has beenrecently reset. For details, see Wirelessly connecting your pump andtransmitter using Auto Connect, on page 175.• The Airplane Mode is turned off on your pump.• You have applied the tape correctly, as instructed in the sensor userguide.2. Disconnect the transmitter from the sensor for at least 10 seconds.3. While the light on the transmitter is blinking, reconnect the transmitter withthe sensor to restart communication and select OK on the pump toacknowledge the alert.4. Depending on whether the light blinked when you connected the transmitterto the sensor, select Yes or No on your pump and do one of the following:■ troubleshooting Troubleshooting 235MP6025958-022 / ARELEASED
• If the transmitter light did not blink, you need to charge your transmitter.When your transmitter is charged, start your sensor. For details, seeStarting the sensor, on page 182.• 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 to15 minutes for your pump to find the sensor signal.6. If your pump still cannot find the sensor signal, make sure you are away fromany electronic devices that might cause interference, such as cellular phonesand other wireless devices, and select OK.7. If 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 graphdisplays "Sensor signal not found. See User Guide," call your localrepresentative for assistance.Calibration not acceptedCalibration not accepted alert occurs when one of the following happens:• System was unable to use the BG meter readings you entered to calibrateyour sensor.• System rejects two calibrations in a row from the same sensor.• The transmitter was unable to receive the calibration BG meter readings fromthe pump due to failed sensor signal.For details on when and how to calibrate your sensor, see Calibrating your sensor,on page 183.Why does the SmartGuard suspend by sensor icon on my Home screenappear gray?The SmartGuard suspend by sensor icon appears gray on the Home screenwhen either the Suspend on low or Suspend before low feature is unavailable. Thesuspend features may be unavailable due to the following conditions:• A suspend event has occurred recently.236 Chapter 13MP6025958-022 / ARELEASED
After a Suspend before low or Suspend on low event occurs, there is a periodof time when the suspend functionality is unavailable. This time will varydepending on whether or not you respond to the suspend event. Typically,the suspend features will be unavailable for 30 minutes after your basal insulindelivery is resumed. For details, see When Suspend before low is unavailable, onpage 159 or When Suspend on low is unavailable, on page 162.• No SG values are available.SG values may be unavailable because:• 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 yoursensor, on page 183.• Your pump has lost connection to the sensor.Move your pump closer to the sensor. For more details, see My pumpcannot find the sensor signal, on page 234.• The sensor glucose value received was outside the expected range andwas not displayed.Select OK to clear the alert. If the issue continues, you may need toreplace the sensor.If the issue persists, call your local representative for assistance.■ troubleshooting Troubleshooting 237MP6025958-022 / ARELEASED
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maintenanceMP6025958-022 / ARELEASED
MP6025958-022 / ARELEASED
MaintenanceRead your warranty statement included with your pump for information aboutwhat is covered during your warranty period.Cleaning your pumpCaution: Never use organic solvents, such as lighter fluid, nail polishremover, or paint thinner to clean your pump. Never use lubricantswith your pump. When cleaning your pump, be sure to keep thereservoir compartment dry and away from moisture.Make sure you have the following supplies ready for cleaning your pump: three orfour 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.2. Using the cloth, wipe the outside of the pump.3. Dampen a clean cloth with water and wipe to remove any detergent residue.4. Dry with a clean cloth.5. Wipe your pump with a 70% alcohol wipe for disinfection.6. Using a dry clean cotton tip, remove any battery residue from the battery cap.7. Using a dry clean cloth, remove any battery residue from the batterycompartment opening. Maintenance 241■ maintenanceMP6025958-022 / ARELEASED
Cleaning your transmitterAlways refer to your transmitter user guide for instructions on cleaning thetransmitter.Storing your pumpStorage 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 anew AA battery for 8 to 12 hours every six months to recharge theinternal power source. WARNING: Active insulin is now cleared. Any active insulin trackedprior to the pump entering storage mode is not included in anynew 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 InsertBattery alarm for 10 minutes or until you place your pump intostorage mode. 2. Press and hold until your screen turns off.Caution: Store your pump at room temperature. While instorage, the pump should never be exposed to temperaturesabove 35°C (95°F). Waking your pump from storage mode1. Insert a new AA battery into your pump. For details, see Inserting the battery,on page 22.242 Chapter 14MP6025958-022 / ARELEASED
A Pump Error message appears.2. Select OK.Your pump displays a Power Loss alarm.3. Select OK.The Time & Date screen appears.4. Enter the current Time, Time Format and Date.5. Select 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 youneed to, reapply your last saved settings by using the Restore Settings optionas instructed in Restoring your settings, on page 143.Storing your transmitterAlways refer to your transmitter user guide for instructions on storing yourtransmitter.■ maintenance Maintenance 243MP6025958-022 / ARELEASED
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product specifications and safety informationMP6025958-022 / ARELEASED
MP6025958-022 / ARELEASED
Product specifications and safetyinformationThis chapter provides detailed product specifications and safety information.Product specificationsThis section provides detailed information on product specifications.Alarm and alert escalationThe following alerts may escalate to a siren:• Alert before high • Check connection• Alert before low • Lost sensor signal• Alert on high • No calibration occurred• Alert on low • Possible signal interference• Basal delivery resumed • Rise Alert• BG not received • Sensor expired• Calibration not accepted • Sensor signal not found• Calibrate now • SG value not available• Cannot find sensor signal • Suspend before low (only if Alert before low is on)• Change sensor • Transmitter battery depleted Product specifications and safety information 247■ product specifications and safety informationMP6025958-022 / ARELEASED
Minutes fromalarm oralertAudio Audio andvibrationVibration0 Audio Audio and vibrate Vibrate1 Audio Audio and vibrate Vibrate2 Audio Audio and vibrate Vibrate3 Audio Audio and vibrate Vibrate4 Audio Audio and vibrate Vibrate5 Audio Audio and vibrate Vibrate6 Audio and vibrate Audio and vibrate Audio and vibrate7 Audio and vibrate Audio and vibrate Audio and vibrate8 Audio and vibrate Audio and vibrate Audio and vibrate9 Audio and vibrate Audio and vibrate Audio and vibrate10 Siren and vibrate Siren and vibrate Siren and vibrateNote: 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 frequencyThe following table lists the various audible tones and their correspondingfrequencies:Tone name Frequency tolerance (+/- 1%)Alarm 1655 Hz followed by 3310 HzAlternate Alarm 1850 HzSiren (escalated alarm) 1655 Hz, followed by 3310 HzAlert 934 Hz248 Chapter 15MP6025958-022 / ARELEASED
Tone name Frequency tolerance (+/- 1%)High Sensor Glucose 1312 Hz, followed by 1410 Hz, 1500 Hz, 1619 Hz,1722 HzLow SG 1722 Hz, 1619 Hz, 1500 Hz, 1410 Hz, 1312 HzLost SG 1485 Hz, followed by 1395 Hz, 1320 Hz, 1395 HzMessage tone 1655 HzReminder tone 934 HzFill tubing tone 1850 HzBolus delivery cancellation tone 1485 Hz, followed by 1655 Hz and 1485 HzLoading complete tone 934 HzReservoir loading in progresstone1850 HzEasy Bolus activation 1045 HzEasy Bolus step 1 increment 1175 HzEasy Bolus step 2 increment 1320 HzEasy Bolus step 3 increment 1395 HzEasy Bolus step 4 increment 1570 HzEasy Bolus step 5 increment 1760 Hz BacklightType LED (Light-emitting Diode)Time out 15 seconds (default), 30 seconds, one minute,three minutesTime out when battery is low 15 seconds (default), 30 seconds Basal deliveryDelivery rate range 0 to 35 units per hour or the Max Basal Rateamount, whichever is lower.Max Basal Rate default 2 units per hour■ product specifications and safety information Product specifications and safety information 249MP6025958-022 / ARELEASED
Basal patterns Maximum of 8 patterns. Each pattern covers a24 hour period and can have up to 48 rates. Ratesare set in 30 minute increments.Basal pattern names Fixed names: Basal 1, Basal 2, Basal 3, Basal 4, Basal 5,Workday, Day Off, Sick DayIncrements • 0.025 units per hour for basal amounts in therange 0 to 0.975 units• 0.05 units per hour for basal amounts in the range1 to 9.95 units• 0.1 units per hour for basal amounts of 10 to35 units BG TargetMaximum targets 8Range 60 to 250 mg/dLDefault value for High BGtargets and Low BG targetsNone BG meter valueThe most recent BG value received from the meter. If you are using a compatibleBayer meter, this value appears on the Home screen when the Sensor feature isoff. This value also appears in the Bolus Wizard screen when setting up a bolus.Expiration 12 minutesRange 20 to 600 mg/dL Bolus deliveryBolus Speed options • Standard: 1.5 units/minute• Quick: 15 units/minuteBolus programming increments • 0.025 units•0.05 units•0.1 units250 Chapter 15MP6025958-022 / ARELEASED
Fluid delivered/stroke • 0.25 μL (microliter) for 0.025 unit pump stroke• 0.5 μL for 0.05 unit pump stroke• 2.0 μL for 0.2 unit pump stroke Bolus Wizard feature default settingsItem Default Limits IncrementsCarb units grams - -Insulin to carb (orexchange) ratioNone 1–200 g/u(0.075–15.0u/exch)0.1 g/u for 1–9.9 g/u;1 g/u for ratios of 10 g/u to200 g/u(0.001 u/exch for0.075–0.099 u/exch0.01 u/exch for 0.10–9.99 u/exch;0.1 u/exch for 10–15 u/exch)Insulin SensitivityFactorNone 5–400 mg/dL 1 mg/dLBG Target None 60–250 mg/dL 1 mg/dLActive InsulinTime6 hours 2 to 8 hours 15 minutes Bolus Wizard feature specificationsThere 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 carbunits are in grams.1. If your current BG is greater than your High BG Target, the Bolus Wizardfeature subtracts active insulin from the BG correction estimate, then adds thisto the food estimate to get the total bolus estimate. However, if the result ofsubtracting 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 Product specifications and safety information 251MP6025958-022 / ARELEASED
(food estimate)where:=(correction estimate)total bolus estimateA = food (grams)B = carb ratioC = current BGD = High BG TargetE = insulin sensitivity- active insulin+ABC - DEFood estimate:Carb grams ÷ Carb ratio = Units of insulinCorrection estimate:(Current BG - High BG Target) ÷ Insulin sensitivity - Active insulin = Units ofinsulinTotal bolus estimate:Food estimate + Correction estimate = Units of insulin2. If your current BG is less than your Low BG Target, the Bolus Wizard featureadds the BG correction estimate to the food estimate to get the total bolusestimate.(food estimate)where:=(correction estimate)total bolus estimateA = food (grams)B = carb ratioC = current BGD = Low BG TargetE = insulin sensitivity+ABC - DEFood estimate:Carb grams ÷ Carb ratio = Units of insulinCorrection estimate:(Current BG - Low BG Target) ÷ Insulin sensitivity = Units of insulinTotal bolus estimate:252 Chapter 15MP6025958-022 / ARELEASED
Food estimate + Correction estimate = Units of insulin3. If your current BG is between or equal to your High or Low BG Target, thetotal bolus estimate is based only on the food estimate.(food estimate)=total bolus estimate carb ratiofood (grams)Food estimate:Carb grams ÷ Carb ratio = Units of insulinNote: When the current BG is below the Low BG Target, an activeinsulin amount is not considered in the Bolus Wizard featurecalculations. Total bolus estimate = Food estimate4. If you do not enter a BG, the total bolus estimate is based only on the foodestimate.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 achange that you make, the Square portion is reduced first.• Based on the Active Insulin Time setting you choose, your pump keeps trackof how much insulin is still active in your body. This is shown as Active Insulinor Act. Ins. on the Home screen, Bolus screen, Manual Bolus screen, PresetBolus, and Daily History screens. This prevents stacking of insulin, and lowersthe chances of hypoglycemia.• The Bolus Wizard feature may utilize your current BG measurement,carbohydrate consumption, and active insulin to calculate your estimatedbolus.•Active Insulin Curve■ product specifications and safety information Product specifications and safety information 253MP6025958-022 / ARELEASED
% Insulin RemainingTime (hours)Active Insulin Curve100%90%80%70%60%50%40%30%20%10%0%01 2 3456 9788 Hour7 Hour6 Hour5 Hour4 Hour3 Hour2 HourGraph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22,Number 9, Sept. 1999, page 1501.Carb ratiosMaximum ratio settings Range81 to 200 grams/unit0.075 to 15 units/exch Delivery accuracy• Delivery accuracy: ±5%.• All Normal boluses are delivered within 50 minutes ±3 seconds at Standardrate (75 units, at 1.5 units per minute), and within 5 minutes ±3 seconds atQuick rate (75 units, at 15 units per minute).• The maximum infusion pressure generated and the occlusion thresholdpressure is 86.12 kPa (12.49 psi). The bolus volume generated is 0.01225 mL.• The following is a representative delivery accuracy curve.254 Chapter 15MP6025958-022 / ARELEASED
010 20 30 40 50 60 70 80 90 100−20−15−10−50510152025Trumpet Curve for MMT−1511/1512Observation Window [Minutes]Percent Error [%]Overall ErrorMaximum ErrorMinimum ErrorEasy BolusAllows user to set up and deliver a Normal Bolus when the pump is in SleepMode. This is done using the and with the help of audio and vibration cues.Audio mode range 0 to 20 increments or Max Bolus limit, whichevercomes firstVibrate mode range 0 to 20 increments or Max Bolus limit, whichevercomes firstDefault step size 0.1 unitAdjustable step size 0.1 to 2 units per increment up to Max Bolus limit Environmental conditions• Pump operating temperature range is from 5°C (41°F) to 40°C (104°F).• Air pressure range is from 10.2 psi to 15.4 psi (700 hPa to 1060 hPa).■ product specifications and safety information Product specifications and safety information 255MP6025958-022 / ARELEASED
• Operating humidity range of the case: 20% to 90%.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 of0.025 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 every10 units.• Insulin used to fill the infusion set is recorded in the Daily History.Infusion pressureThe maximum infusion pressure and occlusion pressure is 86.12 kPa (12.49 psi).Insulin delivery default settingsBolus settingsItem Default setting Limits IncrementsBolus Wizardfeature:Off - -Easy bolus: Off - -Easy bolus stepsize:0.1 U 0.1 U to 2 U -Bolus increment: 0.10 U 0.025 U0.05 U0.10 U-Dual/Squarebolus:Off - -Max bolus: 10 U 0 to 75 U (persingle bolus)-Bolus BG CheckReminder:Off 0:00 to 5:00 0:30256 Chapter 15MP6025958-022 / ARELEASED
Basal settingsItem Default setting Limits IncrementsMax Basal Rate 2 U/h 0–35 U/h 0.025 U for0.025–0.975 U/h0.05 U for 1.00–9.95 U/h0.1 U for rates of 10.0 U/hor moreBasal Rate 0.000 U/h 0.000 U/h to MaxBasal Rate setting0.025 U for0.025–0.975 U/h0.05 U for 1.00–9.95 U/h0.1 U for rates of 10.0 U/hor moreTemp Basal Type Percent Percent, Rate N/ATemp BasalPercent100% 0-200% 5%Temp Basal Rate Current basalrate0.0 U/hr to MaxBasal Rate0.025 U for0.025–0.975 U/h0.05 U for 1.00–9.95 U/h0.1 U for rates of 10.0 U/hor moreInsulin sensitivity factorMaximum settings 8Default None. Insulin sensitivity is set during Startup of the BolusWizard.Range 5 to 400 mg/dL/unit Low Reservoir reminderThe values are based on displayed amount, not actual amount.■ product specifications and safety information Product specifications and safety information 257MP6025958-022 / ARELEASED
AlerttypeAlert range Increment DefaultvalueTime First reminder occurs at 2 to 24 hours. Secondreminder occurs one hour before empty. Thesecond reminder is automatic and cannot bechanged by the user.30 min 8 hoursUnits First reminder occurs at 5 to 50 units. Secondreminder occurs at 50 percent of theremaining specified amount. The secondreminder is automatic and cannot be changedby the user.1 unit 20 units Max BolusRange 0 to 75 unitsDefault 10 units Normal bolusRange is 0.025 to 75 units of insulin, and limited by the Max Bolus setting.Occlusion detectionWhen occlusion is detected, the Insulin flow blocked alarm occurs. The occlusionalarm is triggered by an average of 2.23 units of missed insulin (standard bolus) or1.97 units of missed insulin (quick bolus). The MiniMed pump is intended for usewith U100 insulin. This table shows occlusion detection for four different situationswhen using U100 insulin.Rate Minimum timebefore alarmAverage timebefore alarmMaximum timebefore alarmbolus delivery (10 units atstandard speed)71 seconds 95 seconds 136 secondsbolus delivery (10 units atquick speed)9 seconds 10 seconds 14 secondsbasal delivery (1.0 u/h) 2.00 hours 2.50 hours 3.80 hoursbasal delivery (0.025 u/h) 123.38 hours 142.03 hours 178.33 hours258 Chapter 15MP6025958-022 / ARELEASED
Percent temp basalThe default value is 100 percent of basal programming.Range 0 to 200%Default 100% of basal programmingIncrement 5% Program safety checksA single fault condition will cause the pump to suspend insulin delivery. Maximuminfusion with a single fault condition is 0.2 units.Pump dimensionsThe MMT-1512 pump dimensions in inches are approximately2.1 width x 3.34 length x 0.96 depth.The MMT-1512 pump dimensions in centimeters are approximately 5.3 width x 8.5length x 2.44 depth.The MMT-1712 pump dimensions in inches are approximately2.1 width x 3.78 length x 0.96 depth.The MMT-1712 pump dimensions in centimeters are approximately 5.3 width x 9.6length x 2.44 depth.Pump memoryUser settings and pump history are stored in non-volatile memory which will retaindata. The memory size will hold 90 days of pump history before it becomes fulland has to be written over. This means that at any time the user can review amaximum of 90 days of history.Pump weightThe mass of the MiniMed 640G insulin pump (MMT-1512) is approximately 91.9grams.The mass of the MiniMed 640G insulin pump (MMT-1712) is approximately 95.7grams.■ product specifications and safety information Product specifications and safety information 259MP6025958-022 / ARELEASED
Sensor default settingsHigh sensor settingsItem DefaultsettingLimits IncrementsHigh SG alertlimit250 mg/dL 100 to 400 mg/dL 5 mg/dLAlert before high Off - -Alert on high Off - -Time before high 15 minutes 5 to 30 minutes 5 minutesRise Alert Off - -Rise Limit Two uparrows• 1up arrow(1 mg/dL/min)• 2 up arrows(2 mg/dL/min)• 3 up arrows(3 mg/dL/min)•Custom limit(1.0 to 5.0 mg/dL/min)High Snooze 1 hour 5 minutes to 3 hours 5 minutesLow sensor settingsItem DefaultsettingLimits IncrementsLow SG alertlimit60 mg/dL 50 to 90 mg/dL 5 mg/dLSuspend beforelowOff - -Suspend on low Off - -Alert before low Off - -Alert on low Off - -Low Snooze 20 minutes 5 minutes to 1 hour 5 minutes260 Chapter 15MP6025958-022 / ARELEASED
Low sensor settingsItem DefaultsettingLimits IncrementsResume basalalertOff - - ■ product specifications and safety information Product specifications and safety information 261MP6025958-022 / ARELEASED
Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic EmissionsThe MiniMed 640G insulin pump is intended for use in the electromagneticenvironment specified below. The customer or the user of the MiniMed insulinpump should make sure that it is used in such an environment.Emissions Test Compliance Electromagnetic Environment -GuidanceRF emissionsTest: 47 CFR Part 15,Subpart C Section15.247(a)(2)/RSS-210FHSS– DAOO-705,DTS-KDB 558074,ANSI C63.4, RSS-Gen,FCC Part 15 Section15.109, Class B/ANSIc63.4 (2009)•6 dB and 99%Bandwidths: Pass•Maximum OutputPower: Pass• TX SpuriousEmissions: Pass• Power SpectralDensity: PassThe MiniMed insulin pump must emitelectromagnetic energy in order toperform its intended function. Nearbyelectronic equipment may beaffected.RF emissionsEN55011 (2009)+A1Class B The MiniMed insulin pump is suitablefor use in all establishments,including domestic and those directlyconnected to the public low-voltagepower supply network that suppliesbuildings used for domestic purposes.RTCA DO 160G (2010)20.5 and 21.5CompliesARIB STD-T66 Complies262 Chapter 15MP6025958-022 / ARELEASED
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe MiniMed 640G insulin pump is intended for use in the electromagneticenvironment specified below. The customer or the user of the MiniMed insulinpump should assure that it is used in such an environment.Immunity Test IEC 60601 TestLevelComplianceLevelElectromagneticEnvironment -GuidanceElectrostatic discharge(ESD)IEC 61000-4-2±8 kV contact±15 kV air±30 kV air(<5% relativehumidity)For use in a typicaldomestic, commercial,or hospitalenvironment.Electrical fast transient/burst±2 kV for powersupply linesNot applicable Requirement does notapply to this batterypowered device.IEC 61000-4-4 ±1 kV for input/output linesSurgeIEC 61000-4-5±1 kV line(s) toline(s)±2 kV line(s) toearthNot applicable Requirement does notapply to this batterypowered device.Voltage dips, shortinterruptions andvoltage variations onpower supply linesIEC 61000-4-11<5% UT(>95% dip in UT) for 0.5 cycleNot applicable Requirement does notapply to this batterypowered device.Power frequency (50/60 Hz) magneticfieldIEC 61000-4-8400 A/m(continuousfield at 60seconds)4000 A/m (shortduration at 3seconds)400 A/m4000 A/mPower frequencymagnetic fields shouldbe at levelscharacteristic of atypical location in atypical commercial orhospital environment.Note: UT is the a.c. mains voltage prior to application of the test level.■ product specifications and safety information Product specifications and safety information 263MP6025958-022 / ARELEASED
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe MiniMed 640G insulin pump is intended for use in the electromagneticenvironment specified below. The customer or user of the MiniMed insulin pumpshould assure that it is used in such an electromagnetic environment.ImmunityTestIEC 60601LevelComplianceLevelElectromagnetic EnvironmentGuidancePortable and mobile RFcommunications equipment shouldbe used no closer to any part of theMiniMed insulin pump, includingcables, than the recommendedseparation distance calculated fromthe equation applicable to thefrequency of the transmitter.264 Chapter 15MP6025958-022 / ARELEASED
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe MiniMed 640G insulin pump is intended for use in the electromagneticenvironment specified below. The customer or user of the MiniMed insulin pumpshould assure that it is used in such an electromagnetic environment.Radiated RFIEC 61000-4-310 V/m 80 MHz to800 MHz10 V/m800 MHz to2.5 GHz10 V/m80 MHz to800 MHz10 V/m800 MHz to 6GHzRecommended separation distanced = [12/E1]P 80 MHz to 800 MHzd = [23/E1]P 800 MHz to 6 GHzWhere P is the maximum outputpower rating of the transmitter inwatts (W) according to thetransmitter manufacturer and d is therecommended separation distance inmeters (m).Field strengths from fixed RFtransmitters, as determined by anelectromagnetic site surveya, shouldbe less than the compliance level ineach frequency rangeb.Interference may occur in the vicinityof equipment marked with thefollowing symbol:Note: At 80 MHz and 800 MHz, the higher frequency range applies.Note: These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption, and reflection from structures, objects and people.Note: The table is per IEC (EN) 60601-1-2 Edition 3.■ product specifications and safety information Product specifications and safety information 265MP6025958-022 / ARELEASED
Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe MiniMed 640G insulin pump is intended for use in the electromagneticenvironment specified below. The customer or user of the MiniMed insulin pumpshould assure that it is used in such an electromagnetic environment.aField strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radiobroadcasts and TV broadcast cannot be predicted theoretically with accuracy. To assessthe electromagnetic environment due to fixed RF transmitters, an electromagnetic sitesurvey should be considered. If the measured field strength in the location in whichthe MiniMed insulin pump is used exceeds the applicable RF compliance level above,the insulin pump should be observed to verify normal operation. If abnormalperformance is observed, additional measures may be necessary, such as re-orienting orrelocating the MiniMed insulin pump.bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10V/m.266 Chapter 15MP6025958-022 / ARELEASED
Recommended separation distances between the MiniMed 640G insulinpump and common household radio transmittersHousehold RFTransmitterFrequency RecommendedSeparationDistance (meter)RecommendedSeparationDistance (inch)TelephonesCordless Household 2.4 GHz 0.3 12Cordless Household 5.8 GHz 0.3 12TDMA-50 Hz (cell phone) 1.9 GHz 0.3 12TDMA-50 Hz (cell phone) 800 MHz 0.3 12PCS (cell phone) 1.9 MHz 0.3 12DCS (cell phone) 1.8 MHz 0.3 12GSM (cell phone) 900 MHz 0.3 12GSM (cell phone) 850 MHz 0.3 12CDMA (cell phone) 800 MHz 0.3 12Analog (cell phone) 824 MHz 0.3 12CDMA (cell phone) 1.9 MHz 0.3 12WiFi Networks802.11b 2.4 GHz 1 39.5802.11g 2.4 GHz 1 39.5802.11n 2.4 GHz 1 39.5Bluetooth 500 kb/s 2.4 GHz 0.1 3.93ZigBee 250 kb/s 2.4 GHz 0.1 3.93■ product specifications and safety information Product specifications and safety information 267MP6025958-022 / ARELEASED
Recommended separation distances between portable and mobile RFcommunications equipment and the MiniMed 640G insulin pumpThe insulin pump is intended for use in an electromagnetic environment in whichradiated RF disturbances are controlled. The customer or user of the MiniMedinsulin pump can help prevent electromagnetic interference by maintaining aminimum distance between portable and mobile RF communications equipment(transmitters) and the MiniMed insulin pump as recommended below, according tothe maximum output power of the communications equipment.Rated maximum outputpower of transmitter (W)Separation distance according to the frequency oftransmitter (m)80 MHz to 800 MHzd=1.2 P800 MHz to 6 GHzd=2.3 P0.01 0.12 0.230.1 0.38 0.7311.22.310 3.8 7.3100 12 23For transmitters rated at a maximum output power not listed above, the recommendedseparation distance d in meters (m) can be estimated using the equation applicable tothe frequency of the transmitter, where p is the maximum output power rating of thetransmitter in watts (W) according to the transmitter manufacturer.Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency rangeapplies.Note: These guidelines may not apply in all situations. Electromagnetic propagation isaffected by absorption and reflection from structures, objects and people. Wireless communicationQuality of serviceThe CGM transmitter and MiniMed insulin pump are associated as part of an802.15.4 network for which the pump functions as the coordinator and the CGMtransmitter as an end node. In an adverse RF environment the MMT-1512/1712pump will assess channel changing needs based on "noise" levels detected during268 Chapter 15MP6025958-022 / ARELEASED
an energy scan. The pump will perform the energy scan if after 10 minutes noCGM transmitter signal has been received. If the channel change occurs the pumpwill send beacons on the new channel.The CGM transmitter will initiate a channel search when beacon detection fails onthe 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 fromthe CGM transmitter to the pump.In normal operation the CGM transmitter will transmit a packet every 5 minutesand retransmit the packet if the data is corrupted or missed.Radio frequency (RF) communications specificationsUtilizes the IEEE 802.15.4 protocol with the proprietary data format.Pump frequency 2.4 GHz; proprietary Medtronic protocol; range up to1.8 meters (6 feet).Maximum outputpower (EIRP)-1.59 dBmOperating frequencies 2420 MHz, 2435 MHz, 2450 MHz, 2465 MHz, 2480 MHzBandwidth 5 MHz which is allocated channel bandwidth per the IEEEprotocol Data securityThe MiniMed 640G insulin pump is designed to only accept radio frequency (RF)communications from recognized and linked devices (you must program yourpump to accept information from a specific device).The MiniMed 640G system ensures data security via proprietary means and ensuresdata integrity using error checking processes, such as cyclic redundancy checks.■ product specifications and safety information Product specifications and safety information 269MP6025958-022 / ARELEASED
Icon tableFollow instructions for useManufacturerDate of manufacture (year - month)Use by (year - month)Catalogue numberDevice serial numberStorage temperature rangeStorage humidity rangeMagnetic Resonance (MR) unsafeType BF equipment (protection from electrical shock)Radio communicationPump: Protected against the effects of continuous immersion in water (12feet or 3.6 meters for 24 hours).Signifies compliance with Australian EMC, EME and Radio communicationsrequirementsSignifies compliance with Industry Canada EMC and Radio communicationsrequirementsThis symbol means that the device fully complies with MDD 93/42/EEC (NB0459) and R&TTE Directive 1999/5/EC.270 Chapter 15MP6025958-022 / ARELEASED
appendix a: end user software license agreementMP6025958-022 / ARELEASED
MP6025958-022 / ARELEASED
End user software licenseagreementEnd user software license agreementNOTICE TO USER: Certain portions of software contained in this product may becovered 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 feeto cover the cost of shipping and media, by contacting Medtronic MiniMed, Inc.,Director of Software Development, 18000 Devonshire Street, Northridge, CA91325-1219, USA, tel: +1-866-948-6633. End user software license agreement 273■ appendix a: end user software license agreementMP6025958-022 / ARELEASED
274 Appendix AMP6025958-022 / ARELEASED
glossaryMP6025958-022 / ARELEASED
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Glossary active insulin Bolus insulin that has been delivered by the pump and isstill working to lower your blood glucose levels.active insulin adjustment The amount of insulin that is subtracted from your BGcorrection bolus to account for the active insulin that istracked by the Bolus Wizard.Active Insulin Time A Bolus Wizard setting that lets you set the length oftime that bolus insulin is tracked as active insulin.Activity Guard An attachment that can be used to ensure that thereservoir stays secure during activity, or when the pumpis worn by a child.Airplane Mode A feature that temporarily stops your device fromcommunicating wirelessly.alarm An audible beep or vibration with a message to informyou that the pump is no longer delivering insulin. Alarmsrequire immediate action.Alarm History A feature that stores information about recent alarmsand alerts.alert An audible beep or vibration with a message to informyou of a situation that may require your attention.Alert before low An alert that occurs when you are approaching your lowsensor glucose value.Alert Limits The values that you set to determine when low and highglucose alerts are triggered.Glossary 277■ glossaryMP6025958-022 / ARELEASED
Alert on low An alert that occurs when your sensor glucose valuereaches or falls below your low limit.Auto Suspend An alarm that you set to suspend insulin delivery andtrigger an alarm if no buttons are pressed for a specifiedperiod of time. Clearing the alarm resumes insulindelivery.Awake mode A state in which the pump screen is on. Unless you areactively using another screen, your Home screen appears.basal insulin Insulin that is continuously delivered by the pump tomeet your individual insulin needs between meals andduring sleep.basal pattern A set of one or more basal rates that covers a 24-hourperiod.basal rate The amount of continuous basal insulin that youprogram your pump to automatically deliver per hour.BG Abbreviation for blood glucose. See blood glucose.BG Targets The high and low values to which your blood glucose iscorrected when using the Bolus Wizard.Block Mode A feature that restricts the ability to change all settings.You can still perform certain functions, such assuspending insulin delivery, reviewing history, testingyour pump, or clearing alarms and alerts.blood glucose (BG) Refers to glucose (sugar) that is present in the blood,commonly measured by a blood glucose meter.blood glucose meter A device that measures glucose levels in the blood.Bolus BG Check reminder A reminder that you set just after you program a bolus.The reminder notifies you to check your blood glucosewhen the time period that you specified has passed.bolus insulin Insulin used to cover an expected rise in glucose levelsfrom carbohydrates, or to lower a high blood glucosevalue down to your target range.Bolus Speed A feature that lets you choose the speed at which yourdevice delivers bolus insulin.278 GlossaryMP6025958-022 / ARELEASED
Bolus Wizard A feature that uses your individual Bolus Wizard settingsto calculate an estimated bolus amount based on the BGvalues and carbs that you enter. These settings includeCarb Ratio, Insulin Sensitivity Factor, BG Target Range,and Active Insulin Time.calibrate The process of using a meter blood glucose reading tocalculate sensor glucose values.Calibration reminder A reminder you can set to let you know when your nextcalibration is due.cannula Short, thin, and flexible tube placed in the tissue belowthe skin. Insulin is delivered through the cannula into thebody.carb ratio The number of grams of carbohydrates covered by oneunit of insulin. The carb ratio is used to calculate bolusamounts.carb unit The unit of measure for carbohydrates, either grams (g)or exchanges (exch).CGM Abbreviation for continuous glucose monitoring. Seecontinuous glucose monitoring.continuous glucosemonitoring (CGM)A monitoring tool that uses a glucose sensor placedbelow the skin to continuously measure the amount ofglucose in your interstitial fluid.correction bolus Insulin used to lower a high blood glucose value downto your target range.Daily History A feature that displays the actions that you performedusing your device.Dual Wave™ Bolus A type of bolus that provides a dose of insulin deliveredas a combination of a Normal Bolus followed by aSquare Wave Bolus.Easy Bolus™ A feature that lets you deliver a Normal Bolus in presetincrements using only audio or vibrate confirmation.Event Marker A feature that allows you to record events, such as bloodglucose readings, injections, carbohydrates, and exercise.■glossaryGlossary 279MP6025958-022 / ARELEASED
exchange ratio The number of insulin units that are needed to cover1 carbohydrate exchange. The exchange ratio is basedon your individual needs and is used to calculate bolusamounts.food bolus A dose of insulin you give to cover an expected rise inglucose levels from carbohydrates.High limit The value you set to determine when the pump willalert you of a high sensor glucose condition.infusion set Tubing that connects to the reservoir on one end, andhas a needle or cannula on the other end, that youinsert into your body. Insulin travels from the pumpthrough the infusion set into your body.infusion site The location on the body where the infusion set isinserted.insulin sensitivity factor The amount that blood glucose is reduced by one unitof insulin. The insulin sensitivity factor is used tocalculate correction bolus amounts.interstitial fluid The fluid that surrounds the cells in the body.ISIG The signal created by the sensor that is used to calculateyour sensor glucose value. Typically used by Medtronictechnical support representatives when troubleshooting.lock A pump feature that prevents accidental button presses.Low limit The value you set to determine when the pump willalert of a low sensor glucose condition, and also used fordetermining if insulin delivery should be suspended.Manual Bolus A feature that allows you to enter and deliver a dose ofinsulin in the amount that you have determined isnecessary.Max Basal Rate A feature that allows you to set the maximum amountof basal insulin that can be delivered per hour.Max Bolus A feature that allows you to set the maximum bolusamount that can be delivered in one dose.meter A term for any blood glucose meter.280 GlossaryMP6025958-022 / ARELEASED
Missed Meal BolusreminderA reminder that a bolus was not delivered during timeperiods that you specify, often set around your mealtimes.Normal Bolus A type of bolus that provides an entire dose of insulinimmediately.notifications All notifications are designed to get your attention andconvey different types of information. They includealarms, alerts, reminders, and messages.occlusion A blockage or crimp of the cannula or tubing thatprevents proper insulin flow.piston The part of the insulin pump that engages the reservoirand moves insulin through the tubing.Power save mode A state in which your pump is fully functional, but thescreen goes dark to save power. You can set how long ittakes for your screen to enter power save mode bychanging the Backlight setting.Preset Bolus A feature that allows you to set up and save a bolus forspecific meals or snacks that you frequently eat or drink.Preset Temp Basal A feature that allows you to set up and save temporarybasal rates for repeated use.Rate alert An alert that notifies you if your sensor glucose value hasbeen rising or falling faster than the Rise Limit or FallLimit that you have set.reminder A type of notification that you can set to help youremember to do something.reservoir The small container that you fill with insulin and insertinto your delivery device.Resume basal alert An alert that can be set to occur when your pump hasautomatically resumed basal insulin delivery after aSuspend before low or Suspend on low event becauseyour sensor glucose values have met the necessarycriteria. This alert will always occur if basal insulin deliveryhas resumed because the two hour maximum suspendtime has elapsed.■glossaryGlossary 281MP6025958-022 / ARELEASED
Rewind A feature used when changing a reservoir. It returns thepiston to its starting position and allows a new reservoirto be placed into the pump.sensitivity See insulin sensitivity factor.sensor (glucose sensor) The small part of the continuous glucose monitoringsystem that you insert just below your skin to measureglucose levels in your interstitial fluid.sensor glucose (SG) Refers to glucose (sugar) that is present in the interstitialfluid and is measured by a glucose sensor.Set Change reminder A reminder that you can set to change your infusion set.SG Abbreviation for sensor glucose. See sensor glucose.Sleep mode A state in which your pump is fully functional, but thescreen is dark. Your pump automatically enters sleepmode when you have not pressed any buttons for abouttwo minutes.SmartGuard™ A feature that can automatically stop and resume insulindelivery based on your sensor glucose values and lowlimit.Square Wave™ Bolus A bolus delivered evenly over a specified time period.Suspend before low A feature that suspends insulin delivery when the sensorpredicts sensor glucose value is approaching your lowlimit.Suspend Delivery This feature stops all insulin delivery until you resume it.Only the basal insulin restarts when delivery is resumed.Suspend on low A feature that suspends insulin delivery when yoursensor glucose value reaches or falls below your lowlimit.Temp Basal Rate(temporary basal rate)A feature that allows you to temporarily increase ordecrease your current basal rate for a duration of timethat you specify.transfer guard The plastic piece that comes attached to the reservoir. Itis used to connect the reservoir to the insulin vial whilefilling the reservoir with insulin.282 GlossaryMP6025958-022 / ARELEASED
transmitter A device that connects to a glucose sensor. Thetransmitter collects data measured by the sensor andwirelessly sends this data to monitoring devices.■glossaryGlossary 283MP6025958-022 / ARELEASED
284 GlossaryMP6025958-022 / ARELEASED
indexMP6025958-022 / ARELEASED
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Index Aaccessories 15active insulinabout 71adjustment 71clearing settings 144Home screen 26injection warning 71viewing amount 27Active Insulin cleared alert 202Active Insulin Timeabout 66changing 71Airplane Modesetting up 138status bar 29using 137Alarm History 122alarmsabout 199audio options 201Auto Suspend 203Battery failed 203Battery not compatible 203Bolus not delivered 203Bolus stopped 203CGM 216Critical pump error 204Delivery limit exceeded 205emergency siren 201Fill Cannula? 205Insert battery 205Insulin flow blocked 206, 207, 208, 209Loading incomplete 209Manage Settings error 210Max Fill reached 210, 211No reservoir detected 211notification light 200overview 200pump 202, 225Pump error 212, 213Pump restarted 213red icon 200Replace battery 213Replace battery now 214sensor 216siren 201Stuck button 215Alert before high SG setting 156Alert before lowabout 160summary screen 120Alert on high SG setting 156Alert on lowabout 163summary screen 120Alert Silence 193alertsabout 199Active Insulin cleared 202audio options 201BG not received 218Calibrate now 219Calibration not accepted 219Cannot connect device 204Index 287■ indexMP6025958-022 / ARELEASED
Cannot find sensor signal 220CGM 216Change sensor 220Check connection 221Check settings 204Download slow 226Lost sensor signal 221Low battery Pump 209Low battery transmitter 221Low reservoir 210No calibration occurred 222notification light 201overview 201Possible signal interference 222pump 202, 225Reservoir estimate 214Rise alert 223sensor 216Sensor alert occurred 223Sensor expired 223Sensor signal not found 224SG value not available 224silencing 193Transmitter battery depleted 225yellow icon 201areas, for inserting infusion set 103arrows, trend 192audiooptions 33settings 138silencing 193vibrate 29auto connect 175Auto Suspend alarm 203awake mode 34Bbacklightbattery use 21setting up 141basalabout 39current delivery 52daily delivery amount 118delivery 39history 117, 118Home screen 26Max Basal Rate 41patterns 41Preset Temp basal rate 49rate 39settings 40summary 117Temp Basal 47basal patternsabout 42adding 46changing 46deleting 46example 42batteryabout 21alarm 203, 205, 213, 214alert 209belt clip 23compartment location 19disposal 23inserting 22removing 23replacing 22status bar icon 28types 21Battery failed alarm 203Battery not compatible alarm 203belt clippart number 15remove battery cap 23BGHome Screen 26sensor calibration 185BG meter readingsaverage 119manual high 120manual low 120meter high 120meter low 119summary 119288 IndexMP6025958-022 / ARELEASED
BG not received alert 218BG targetBolus Wizard 66setting up 70Block Modestatus bar 31using 139blood glucoseHome screen 26sensor calibration 185bolusabout 59daily delivery amount 118delivery speed 63history 117, 118increment setting 63, 64Max bolus 62reminders 131setting delivery speed 63settings 62summary 117, 118types 59Bolus BG Check reminder, about 130bolus deliveriesabout 59Bolus Wizard 61, 65delivery rate 63Dual Wave 79Easy Bolus 62, 82Manual Bolus 61, 75Max Bolus setting 62Normal bolus 73, 75options 61Preset Bolus 61, 85resume message 214, 215Square Wave 76stopping 88types 59Bolus not delivered alarm 203Bolus stopped alarm 203bolus typesDualWave 60examples 60Normal 59Square Wave 60Bolus WizardActive Insulin Time 66BG target 66Carb ratio 65Dual Wave 79Exchange ratio 65High BG warning 72injection warning 71Insulin Sensitivity Factor 65Low BG warning 72Max Bolus Exceeded warning 73Normal bolus 73Square Wave 77warnings 72Ccalibrateerror 220, 221sensor 183when to 186Calibrate now alert 219calibrationguidelines 186icon 30Calibration not accepted alert 219Calibration reminder 133Cannot connect device alert 204Cannot find sensor signal alert 220cannula alarm 205carb ratio 69Carb Units 140CareLink Personal Software 124Change sensor alert 220Check connection alert 221Check settings alert 204cleaningpump 241transmitter 242■indexIndex 289MP6025958-022 / ARELEASED
clearingactive insulin 144pump settings 143Connect Device message 226connecting pump, transmitterautomatically 175manually 178connection, failure 178Consumableinfusion set 13reservoir 13continuous glucose monitoringabout 151airplane mode 137alarms 216alerts 216calibrating sensor 183connecting pump, transmitter 175examples 164High Settings 156home screen 152Low Settings 157messages 216sensor feature, turning on 167sensor glucose reading 191sensor graph 191settings 155correction estimate 251, 252Critical pump error 204DDaily History 121datechanging 148Startup Wizard 24deliverystop bolus 33suspend all 33Delivery limit exceeded alarm 205Download slow alert 226Dual Wave 60about 79Bolus Wizard 79example 60Manual bolus 81resume message 214, 215setting up 79EEasy bolusabout 82Manual bolus 84setting up 83step size 83electromagnetic emissions 262Electromagnetic environment 267, 268electromagnetic immunity 263emergencykit 4siren 201emergency kit 4emissions 262event markersabout 124blood glucose 125exercise 125food 125injection 125setting up 124exchange ratio 69FFill Cannula? alarm 205food estimate 251, 252, 253Gglucose alerts, silencing 193graph, sensor 191HHigh BG, Bolus Wizard warning 72High Limit SG setting 156High Settingsabout 156entering 167290 IndexMP6025958-022 / ARELEASED
historyabout 117menu 33pump settings, viewing 145summary 117Home Screenabout 26active insulin amount 26basal delivery 26blood glucose reading 26bolus delivery 26CGM, with 152display 21sensor glucose 152sensor glucose reading 152sensor graph 152sensor status icons 152status bar 26time 26trend arrows 152IiconsHome Screen 28sensor status 152SmartGuard 155, 159, 162suspend by sensor 155infusion setabout 93best insertion sites 103disconnect Quick-set 107fill cannula alarm 205fill tubing 101inserting 103reconnect Quick-set 107reservoir alarm 209reservoir and tubing 33reservoir removal 93rotating sites 104setting up 93type 13Insert battery alarm 205insertinginfusion set 103reservoir 99sensor 181insulinbasal 39basal patterns 41bolus 59flow blocked alarm 206, 207, 208, 209icon 29Max Fill reached alarm 210, 211settings 33insulin deliveryBlock Mode 139resuming 54, 163, 174stopping 54, 88suspending 54, 139, 158, 161Insulin flow blockedalarm 206, 207, 208, 209Insulin Sensitivity Factorabout 65setting up 70ISIGview 124Llanguagechanging 141starting 24light, red 200Loading incomplete alarm 209Lost sensor signal alert 221Low battery Pump alert 209Low battery transmitter alert 221Low BG, Bolus Wizard warning 72Low limit 158Low Reservoiralert 132, 210reminder 132Low Settingsabout 157entering 171examples 164■indexIndex 291MP6025958-022 / ARELEASED
Mmaintenance 241Manage Settings error alarm 210managing, pump settings 142Manual bolusDual Wave 81Easy bolus 84Normal bolus 75Square Wave 78Max Basalalarm 205rate 40Max Basal Ratesetting 41Max Bolusalarm 205exceeded 73setting 62warning 63Max Fill reached alarm 210, 211Menu screenabout 32accessing 32audio options 33display 21event markers 33history 33insulin settings 33reminders 33reservoir and tubing 33sensor settings 33suspend delivery 33utilities 33messagesabout 199audio options 202blue icon 202CGM 216Connect Device 226continuous glucose monitoring 216overview 202pump 202, 225Resume bolus 214Resume Dual bolus 214, 215Resume Square bolus 215sensor 216Sensor connected 223Missed Meal Bolus reminder 131modesBlock 139power 34mute alerts 193NNo calibration occurred alert 222No reservoir detected alarm 211Normal bolusabout 73Bolus Wizard 73delivery 73example 60Manual bolus 75resume message 214notification light 200, 201notifications 31Oordering supplies 15Ppatterns, basalabout 42adding 46changing 46copying 46deleting 46example 42personal reminder 129Possible signal interference alert 222power save mode 34Preset Bolusabout 85changing 86deleting 86delivering 87292 IndexMP6025958-022 / ARELEASED
Dual Wave 85renaming 86setting up 85Square Wave 85Preset Temp Basal rateabout 40starting 51Preset Temp basal rateabout 49editing 50managing 49setting up 49previous screen 21pumpalarms 202, 225alerts 202, 225buttons 20cleaning 241connecting, transmitter 175, 178connection status 29deleting, transmitter 181messages 202, 225navigation 24notification light 20overview 19parts illustration 19rewinding 94settings 232storing 242unlocking 26Pump error alarm 212, 213Pump restarted alarm 213pump settingsclearing 143managing 142restoring 143saving 142specifications 247viewing history 145Qquick status 31Quick-set infusion setdisconnecting 107reconnecting 108Rrate, basalabout 39Preset Temp 40Temp 40, 47rate of change arrows 152red light 200, 201remindersabout 129Bolus BG Check 130Calibration 133Low Reservoir 132Menu screen 33Missed Meal Bolus 131Personal 129Set Change 133remote bolus 62, 112Replace battery alarm 213, 214reservoirabout 93compartment image 19inserting 99Loading incomplete alarm 209Low Reservoir alert 210Max Fill reached alarm 210, 211Menu screen 33No reservoir detected alarm 211ordering 15plunger rod 97removal 93Reservoir estimate at 0 U 214setting up 93transfer guard 97type 13Reservoir estimate alert 214restoring, pump settings 143Resume basal alert 163, 164Resume bolus message 214Resume Dual bolus message 214, 215■indexIndex 293MP6025958-022 / ARELEASED
Resume Square bolus message 215resuming suspended delivery 54, 163, 174return to previous screen 21RF communications 267, 268Rise Alertresponding to 223SG setting 157summary screen 120Rise Limit SG setting 157Ssavingpower 34pump settings 142screenActive Insulin Time 71Airplane Mode 138Alarm History 122Audio Options 139Auto Suspend 139Basal Pattern Setup 46BG Check 130BG Target 70Block Mode 140Bolus Increment 64Bolus Speed 64Bolus Wizard Setup 66, 71Carb Ratio 69Carb Unit 140Display Options 141Dual/Square Wave 77Easy Bolus 83Enter Date Screen 25Enter Time 25Event Markers 124Exchange Ratio 69Fill Cannula 106Fill Tubing 102Home Screen 26, 152Language 24, 141Low Reservoir 133Manual bolus 75Max Bolus 63Missed Meal Bolus 131New Reservoir 95Personal reminder 129Preset Bolus Setup 86Preset Temp Setup 50Select Time Format 24Self Test 146Sensitivity 70Sensor Demo 147Sensor Glucose Review 122Sensor Settings 167Set Change 133Summary 117Suspend Delivery 54Temp Basal 48Time and Date 148Welcome screen 24scroll bar 21, 34select 21sensorairplane mode 137alarms 216alerts 216BG not received alert 218calibrating 183, 186calibration alert 219calibration icon 30connecting, transmitter 182disconnecting, transmitter 187expired alert 223feature, turning off 187feature, turning on 167graph 152inserting 181life icon 30messages 216pair 175, 178removing 187settings 33, 167signal alert 220starting 182status icons 152294 IndexMP6025958-022 / ARELEASED
summary 120trend arrows 152wireless connection 175, 178Sensor alert occurredresponding to 223Sensor connected message 223Sensor Demo 146Sensor expired alert 223sensor glucosearrows 192graph 191high settings 156history 191low settings 157review 122rise alert 223sensor alert occurred 223sensor graphabout 191trend arrows 192Sensor signal not found alert 224serial number, pump 12Set Change reminder 133settingsbasal 40bolus 62Bolus Wizard 65CGM 155low SG 157product specifications 247startup 24troubleshooting 229SG average 120SG Std. Dev. 120SG value not available alert 224silencing alerts 193siren 201sleep mode 35SmartGuardabout 152icon 155, 159, 162summary 121Square Wave 60about 76Bolus Wizard 77example 60Manual bolus 78resume message 214, 215setting up 76startingsensor 182Startup Wizardabout 24re-entering settings 232using 24status barabout 28Airplane Mode 29audio mode 29battery 28Block Mode 31CGM, with 152CGM, without 26Connection icon 29icons 28insulin amount 29sensor calibration 30sensor life 30time 26status screensabout 31notifications 31pump 31quick status 31sensor 31settings review 32stoppingbolus 88insulin delivery 54storage mode 242Stuck button alarm 215summary screenabout 117basal 118BG meter readings 119bolus 118■indexIndex 295MP6025958-022 / ARELEASED
overview 118total carbs 118total daily dose 118viewing 117supplies, ordering 15Suspend before lowabout 158examples 164, 165, 166unavailable 159suspend by sensoricon 155Suspend on lowabout 161examples 166unavailable 162suspended delivery, resumingautomatically 163manually 54, 174suspending insulin delivery 54, 139, 158, 161Ttemp basal rateabout 47percent 47preset 40rate 47starting 48types 47Time before high SG setting 156time, current changing 148transmittercommunication 29connecting, pump 175, 178deleting, from pump 181signal alert 220Transmitter battery depleted alert 225trend arrows 192troubleshooting 229tubingfilling 101image 19Max Fill reached alarm 210, 211UunavailableSuspend before low 159Suspend on low 162unlocking 26utilities 33Vviewing history, pump settings 145Wwireless connectionautomatic 175failure 178manual 178296 IndexMP6025958-022 / ARELEASED
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298 IndexMP6025958-022 / ARELEASED
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