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
Contents
- 1. Users manual
- 2. Users Manual 2
- 3. Users Manual 3
- 4. Users Manual 4
- 5. Users Manual 5
Users Manual 5
MP6025958-022 / A WARNING: If you receive a critical error on your pump, the following screen displays and the pump sirens. Immediately disconnect from your insulin pump and discontinue use. Contact your local representative for assistance. Remember, your body still needs insulin while your pump is removed. It is important that you consult your healthcare professional to determine an alternate method of receiving insulin while your pump is removed. Alarms An alarm warns you that the pump detected something that prevents insulin from being delivered. It is important that you respond to an alarm. WARNING: Do not ignore your pump when it has an alarm because all insulin delivery is stopped, which may lead to high blood glucose and ketoacidosis. 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 a continuous repeating pattern. The notification light is shown in Using the buttons, on page 20. 200 Chapter 12 MP6025958-022 / A Audio: Depending on your Audio Options settings, the pump emits an alarm tone, a continuous three-pulse-and-pause vibration pattern, or both the alarm tone and vibration. Alerts An alert makes you aware of a situation that may require your attention. An alert is less serious than an alarm. When an alert occurs: Display: The pump displays a notification with a yellow icon and instructions. Notification light: The red notification light on your pump blinks once, followed by a pause, then blinks once again in a continuous repeating pattern. The notification light is shown in Using the buttons, on page 20. Audio: Depending on your Audio Options settings, the pump either beeps or vibrates in a continuous three-pulse-and-pause pattern, or does both. To clear an alert, press and then make a selection. If you do not respond to an alert, the pump beeps every five minutes or every fifteen minutes, depending on the alert. Some alerts will also escalate to a loud emergency siren after ten minutes. For more information, see Alarm and alert escalation, on page 247. Note: If an alert occurs when you are in a screen other than the Home screen, the alert message may appear after you return to the Home screen. Alarms, alerts, and messages 201 alarms, alerts, and messages If you do not respond to an alarm, after ten minutes the alarm tone escalates to a loud emergency siren. For more information, see Alarm and alert escalation, on page 247. ■ 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 alarm repeats until the underlying problem is fixed. MP6025958-022 / A Messages A message informs you about the status of your pump or if you need to make a decision. When a message occurs: Display: The pump displays a notification with a blue icon and instructions. Notification light: Does not illuminate or blink. Audio: Depending on the message, the pump emits a message tone, an alert tone, or no tone. Depending on your Audio Options settings, you may hear a tone, feel a one-pulse-only vibration, or hear a tone and feel a vibration. You clear the message by pressing and make a selection. Pump alarms, alerts, and messages The following table lists the most common or serious alarms, alerts, and messages related to your pump. The table also explains the meaning, consequences, and the reasons why these notifications appear, and provides steps for problem resolution. EA Title and text Explanation EL Active Insulin cleared Any Active Insulin amount has been cleared. An alarm has cleared your active insulin amount. Your active insulin amount is now at 0 units. Next steps • Select OK to clear the alarm. • The active insulin tracked prior to pump restart is not included in new Bolus Wizard calculations. Consult your healthcare professional for how long you need to wait after active insulin is cleared before you can rely on the active insulin calculation of your Bolus Wizard • You can check Daily History for the time and amount of your last bolus. For more information, see Daily History, on page 121. 202 Chapter 12 MP6025958-022 / A Title and text Explanation Next steps Auto Suspend You have not pressed any buttons during the time specified in the Auto Suspend settings. • To clear the alarm and resume basal insulin delivery, select Resume Basal. The pump battery does not have enough power. • Select OK to clear the alarm. Insulin delivery suspended. No buttons pressed within time set in Auto Suspend. • Remove the old battery and insert a new AA battery. For details, see About batteries, on page 21. Battery not compatible. See User Guide. • To clear the alarm, remove the incompatible battery. pump is not compatible. • Insert a new AA battery. For ED Bolus not delivered. Bolus entry timed out before delivery. If bolus intended, enter values again. The battery that you inserted into the Bolus values entered, but bolus LE was not delivered within 30 seconds. Bolus stopped Cannot resume bolus or cannula fill. XX.XXX of YY.YYY U delivered. ZZ.ZZZ U not delivered. If needed, enter values again. The battery power was exhausted while a bolus or Fill Cannula was in progress. compatible battery types, see About batteries, on page 21. • Select OK to clear the alert. • If bolus delivery was intended, check your BG, re-enter bolus values and deliver bolus. • Note the amount of insulin not delivered. • Replace the AA battery. • Select OK to clear the alarm. • Deliver the remaining bolus amount if needed. Alarms, alerts, and messages 203 alarms, alerts, and messages Insert a new AA battery. ■ Battery failed • Check your BG and treat as necessary. MP6025958-022 / A Title and text Explanation Next steps Cannot connect device • You may be trying to connect a device that is not compatible with your pump. • Select OK to clear the alert. This device is incompatible with your pump. See User Guide. • You are trying to connect a transmitter to your pump but another transmitter is already wirelessly connected to your pump. Check settings Startup Wizard settings complete. Check and set up your other settings. Critical pump error • If you are replacing your transmitter, make sure that you first delete the old transmitter from your pump before you try to connect your new transmitter. Only one transmitter can be connected to your pump. For details, see Deleting the transmitter from your pump, on page 181. • Select OK to clear the alert. Delivery stopped. Pump not working properly. Stop using pump. Remove infusion set from body. Consider other insulin treatment. See User Guide. Some settings have been cleared or reverted to factory default values. • Check the list of devices that are compatible with your pump in Optional devices, on page 14. Your pump has encountered a critical error. • Review any settings that you have not already set in Startup Wizard and re-enter the values, if necessary. The pump is not able to deliver insulin. Remove your infusion set and stop using your pump. • Consider another form of insulin delivery. • Check your BG, and treat as necessary. • Write down the error code that appears on the alarm screen. • Call your local representative for assistance with your pump. 204 Chapter 12 MP6025958-022 / A Title and text Explanation Next steps Delivery limit exceeded You have attempted to deliver more insulin than expected based on your Max Bolus and Max Basal settings. • Check your BG. You had the Fill Cannula screen displayed for 15 minutes. • To proceed and fill the cannula, select Fill. The battery was removed from the pump. • Insert a new AA battery. Delivery stopped. Check BG. See User Guide for more information. Insert battery Delivery stopped. Insert a new battery now. • Continue to monitor your BG. • If you do not need to fill the cannula, select Done to skip this process. • The alarm clears when you insert a new battery. ED • The pump powers off after 10 minutes unless you insert a new battery. Alarms, alerts, and messages 205 alarms, alerts, and messages Select Fill to fill cannula or select Done if not needed. • Check Bolus History and reevaluate your need for insulin. ■ Fill Cannula? • Select Resume Basal. MP6025958-022 / A Title and text Explanation Next steps Insulin flow blocked Your pump has detected that the basal or bolus insulin flow was blocked. • Check your blood glucose. Consider checking ketones and take an injection if needed. Check BG. Consider injection and testing ketones. Change reservoir and infusion set. • Remove your infusion set and reservoir. • Select Rewind to start the new reservoir process using a new infusion set and reservoir. If a bolus delivery was in progress when the alarm occurred: • Check the Daily History screen for the amount of bolus already delivered before the pump alarmed. ED 206 Chapter 12 • Consider delivering remaining bolus, if the bolus insulin was not included in an insulin injection. MP6025958-022 / A Title and text Explanation Next steps Insulin flow blocked Your pump has detected that the insulin flow was blocked and there is no insulin in the reservoir. • Check your blood glucose. Consider checking ketones and take an injection if needed. • Remove your infusion set and reservoir. • Select Rewind to start the new reservoir process using a new infusion set and reservoir. ■ Check BG. Consider injection and testing ketones. Estimated 0 U insulin in reservoir. Change reservoir and infusion set. when the alarm occurred: • Check the Daily History screen for the amount of bolus already delivered before the pump alarmed. ED • Consider delivering remaining bolus, if the bolus insulin was not included in an insulin injection. Alarms, alerts, and messages 207 alarms, alerts, and messages If a bolus delivery was in progress MP6025958-022 / A Title and text Explanation Next steps Insulin flow blocked Your pump has detected the insulin flow was blocked while filling the cannula. • Check your blood glucose. Consider checking ketones and take an injection if needed. Fill Cannula stopped. Remove infusion set from body. Change reservoir and infusion set. • Remove your infusion set and reservoir. • Select Rewind to start the new reservoir process using a new infusion set and reservoir. If a fill cannula was in progress when the alarm occurred: • Check the Daily History screen for the amount of bolus already delivered before the pump alarmed. ED 208 Chapter 12 • Consider delivering remaining bolus, if the bolus insulin was not included in an insulin injection. MP6025958-022 / A Title and text Explanation Next steps Insulin flow blocked Your pump has detected the insulin flow was blocked while filling the tubing. Possible connection issue between the tubing and reservoir. • Remove the reservoir and select Rewind to restart the fill tubing process. Fill Tubing stopped. Remove reservoir and select Rewind to restart. • Disconnect tubing from reservoir. • If this alarm occurs again, use a new infusion set. If a fill tubing delivery was in progress when the alarm occurred: • Check the Daily History screen for the amount of bolus already delivered before the pump alarmed. Loading incomplete You pressed Remove reservoir and select Rewind to restart loading. after loading began. Low battery Pump The battery in the pump is low on power. Replace battery soon. • Consider delivering remaining bolus, if the bolus insulin was not included in an insulin injection. • Remove the reservoir to start again. • Select Rewind and follow the onscreen instructions. • Select OK to clear the alert. • Replace the AA battery as soon as possible. Otherwise, insulin delivery stops, and the Replace Battery Now alarm occurs. • If the pump is delivering a bolus or filling the cannula, wait until delivery is complete to replace battery. Alarms, alerts, and messages 209 alarms, alerts, and messages • Continue following the steps displayed on the pump using the same infusion set and reservoir. ■ • Be sure tubing is not crimped or bent. MP6025958-022 / A Title and text Explanation Next steps Low reservoir Your reservoir is low on insulin, according to the number of hours or units set in the Low Reservoir Reminder. • Select OK to clear the alert. A pump error has occurred, and you need to restart your pump. Your backup settings have been lost, but your current settings are unchanged. • Select OK to restart your pump. Your current settings are unchanged. Only your backup settings are lost. XX hours remaining. Change reservoir. or: XX units remaining. Change reservoir. Manage settings error Delivery stopped. Backup settings cleared from Manage Settings. Current settings are working properly. Select OK to restart. See User Guide. 3X.X U. Did you see drops at the end of tubing? 210 Chapter 12 • If you do not change the reservoir after you receive this alert, you will receive a second Low reservoir alert when the insulin level reaches half of your original alert amount. For more details, see Low Reservoir reminder, on page 132. ED Max Fill reached • Change the reservoir soon. You have exceeded the number of units expected to fill the tubing. By now, insulin should be at the end of the tubing. • When the pump restarts, follow instructions on the pump display. • If the pump was delivering a bolus or filling the cannula, check Daily History and evaluate your need for insulin. • Consider saving your current settings. For details, see Saving your settings, on page 142. • If you see drops at the end of the tubing, select Yes. • If you do not see drops, select No. • Follow instructions displayed on the pump. MP6025958-022 / A Title and text Explanation Next steps Max Fill reached You have exceeded the number of units expected to fill the tubing. By now, insulin should be at the end of the tubing. • Remove the reservoir. There is no reservoir in the pump or the reservoir is not properly locked into place. • Select Rewind. The internal power source in your pump is unable to charge. Your pump is operating on the AA battery only. • Select OK to clear the alert. 4X.X U. Remove reservoir and select Rewind to restart New Reservoir procedure. Power error detected Delivery stopped. Record your settings by uploading to CareLink or write your settings on paper. See User Guide. AA battery was removed for more than 10 min or power was lost. Select OK to re-enter time and date. • When prompted, ensure that your reservoir is inserted and properly locked into place. EA Power loss • Ensure that your reservoir is filled with insulin. Your pump battery has been out for more than ten minutes, and your pump has lost power. You must reset your time and date. • Check your BG and treat as necessary. • Record your settings as soon as possible because your AA battery may not last long. • Call your local representative for assistance with your pump. • Select OK to go to the Time & Date screen. • Enter the current time, time format, and date. Alarms, alerts, and messages 211 alarms, alerts, and messages Rewind before loading reservoir. • Select Rewind to restart the new reservoir procedure. ■ No reservoir detected • Check if you still have insulin in the reservoir. If you do, you can continue using the same reservoir. MP6025958-022 / A Title and text Explanation Next steps Pump error Your pump encountered an error and will restart. Your pump settings will return to factory default values. • When the pump restarts, follow instructions on the pump display. Delivery stopped. Current settings cleared. Pump restart needed. Select OK to restart and then reenter your settings. See User Guide. • After restart, check settings and re-enter values as needed. • If you recently saved backup settings in Manage Settings, use Restore Settings. • If the pump was delivering a bolus or filling the cannula, check Daily History and reevaluate your need for insulin. • If this alarm recurs frequently, write down the error code displayed on the alarm screen (you can also find it in your Alarm History) and contact your local representative for assistance with your pump. Pump error A pump error has occurred, you need to restart your pump. Delivery stopped. Settings unchanged. Pump restart needed. Select OK to restart. See User Guide. • Select OK to restart your pump. • If the pump was delivering a bolus or filling the cannula, check Daily History and reevaluate your need for insulin. • If this alarm recurs frequently, write down the error code displayed on the alarm screen (you can also find it in your Alarm History) and contact your local representative for assistance with your pump. 212 Chapter 12 MP6025958-022 / A Next steps Pump error Your pump encountered an error but a restart is not necessary. The issue is resolved. Your settings are not changed. • Select OK to resume basal delivery. Your pump has encountered a problem and has restarted. Your settings have not been changed. • Select OK to continue. Battery life is low and will be exhausted within 30 minutes. • Select OK to clear the alert. Delivery stopped. Settings unchanged. Select OK to continue. See User Guide. Pump restarted Battery life less than 30 minutes. To ensure insulin delivery, replace battery now. • If this alarm recurs frequently, write down the error code displayed on the alarm screen (you can also find it in your Alarm History) and contact your local representative for assistance with your pump. ED Delivery stopped. Settings unchanged. Select OK to continue. See User Guide. Replace battery • If the pump was delivering a bolus or filling the cannula, check Daily History and reevaluate your need for insulin. • If the pump was delivering a bolus or filling the cannula, check Daily History and re-evaluate your need for insulin. • If this alarm recurs frequently, write down the error code displayed on the alarm screen (you can also find it in your Alarm History) and contact your local representative for assistance with your pump. • Replace the AA battery. Alarms, alerts, and messages 213 alarms, alerts, and messages Explanation ■ Title and text MP6025958-022 / A Title and text Explanation Next steps Replace battery now Insulin delivery has stopped due to low power. Battery was not replaced after the Low battery Pump alert. Replace the battery immediately to resume insulin delivery. For details, see Removing the battery, on page 23. Your reservoir level is estimated at 0 units. • Select OK to clear the alert. A normal bolus delivery has been • Check the message to see how much of the bolus was actually Delivery stopped. Battery must be replaced to resume delivery. Reservoir estimate at 0 U To ensure insulin delivery, change reservoir. Resume bolus? XXX of YYY U delivered. Resume delivery of ZZZ U? interrupted because the pump battery was removed. If it is within 10 minutes since this interruption, you • Change the reservoir now. delivered. • To cancel remaining amount of bolus, select Cancel. ED • To resume remaining amount of bolus, select Resume. can resume this bolus. Resume Dual bolus? XX of YY U delivered. Resume delivery of ZZ U for XX:XX hr? The Square portion of Dual Bolus delivery has been interrupted. If it is within 10 minutes since this interruption, you can resume this bolus. 214 Chapter 12 • Check the message to see how much of the Dual Wave bolus was actually delivered. • To cancel remaining amount of bolus, select Cancel. • To resume remaining amount of bolus, select Resume. MP6025958-022 / A Title and text Explanation Next steps Resume Dual bolus? The Now portion of a Dual Wave bolus delivery has been interrupted because the pump battery was removed. If it is within 10 minutes since this interruption, you can resume this bolus. • Check the message to see how much of the Dual Wave bolus was actually delivered. The Square Wave bolus delivery was interrupted. If it is within 10 minutes since this interruption, you can resume this bolus. • Check the message to see how much of the Square Wave bolus was actually delivered. The pump has detected that a button has been pressed for an unusually long time. • Select OK to clear the alarm. XX of YY U delivered. Resume delivery of ZZ U now, and AA U Square for XX:XX hr? Stuck button Button pressed for more than 3 minutes • To cancel remaining amount of bolus, select Cancel. • To resume remaining amount of bolus, select Resume. • If this alarm occurs again, contact your local representative for assistance with your pump. If you are unable to clear the alarm: • Consider another form of insulin, because your pump is not delivering insulin. • Check your BG and treat as necessary. • Contact your local representative for assistance with your pump. Alarms, alerts, and messages 215 alarms, alerts, and messages XX of YY U delivered for XX:XX hr. Resume delivery of ZZ U for XX:XX hr? • To resume remaining amount of bolus, select Resume. ■ Resume Square bolus? • To cancel remaining amount of bolus, select Cancel. MP6025958-022 / A Title and text Explanation Next steps Wrong key pressed Wrong button selected while unlocking the pump. • Select OK to clear the alert. Try again • Try to unlock the pump. Select the highlighted key when prompted. For more information, see Unlocking your pump, on page 26. CGM (sensor) alarms, alerts, and messages The following table lists the most common or serious alarms, alerts, and messages related to your sensor glucose readings, as well as the status of your transmitter and sensor. The table also explains the meaning, consequences, and the reasons why these notifications appear, and provides steps for problem resolution. Title and text Explanation Alert before high Your SG value is approaching your specified high limit. ED Sensor glucose approaching High Limit. Check BG. Alert before low Sensor glucose approaching Low Limit. Check BG. 216 Chapter 12 Alert on high XXX mg/dL High sensor glucose. Check BG. Next steps • Select OK to clear the alert. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. Your SG value is approaching your specified low limit. • Select OK to clear the alert. Your SG value is at or above your specified high limit. • Select OK to clear the alert. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. MP6025958-022 / A Title and text Explanation Next steps Alert on low XXX mg/dL Your SG value is at or below your specified low limit. • Select OK to clear the alert. Your SG value is at or below your specified low limit, and the pump has suspended insulin delivery due to a Suspend on low or Suspend before low event. • Select OK to clear the alert. Low sensor glucose. Check BG. Basal delivery resumed at XX:XX after suspend by sensor. Check BG. Your pump is resuming basal insulin delivery after a Suspend on low or Suspend before low event occurred. • Select OK to clear the alert. Your pump is resuming basal insulin delivery after a Suspend before low or a Suspend on low event occurred, because you have turned off the Suspend before low or the Suspend on low feature. • Select OK to clear the alert. Low settings change caused basal to be resumed at XX:XX. Check BG. • Follow instructions from your healthcare professional and continue to monitor your BG. ED Basal delivery resumed Basal delivery resumed • Check your BG. alarms, alerts, and messages Low sensor glucose. Insulin delivery suspended since XX:XX. Check BG. • Follow instructions from your healthcare professional and continue to monitor your BG. ■ Alert on low XXX mg/dL • Check your BG. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. Alarms, alerts, and messages 217 MP6025958-022 / A Title and text Explanation Next steps Basal delivery resumed Your pump is resuming basal insulin delivery two hours after a Suspend before low or Suspend on low event occurred. • Select OK to clear the alert. Your pump is resuming basal insulin delivery two hours after a Suspend before low or Suspend on low event occurred. • Your pump has resumed basal insulin delivery; however, your SG value is still at or below your low limit. Maximum 2 hour suspend time reached. Check BG. Basal delivery resumed Maximum 2 hour suspend time reached. SG is still under Low limit. Check BG. Place pump close to transmitter. Select OK to resend BG to transmitter. The transmitter was unable to receive the calibration BG meter readings from the pump. Chapter 12 • Follow instructions from your healthcare professional and continue to monitor your BG. • Select OK to clear the alert. • Check your BG. • Follow instructions from your healthcare professional and continue to monitor your BG. BG not received 218 • Check your BG. • Move your pump and transmitter closer together. • Select OK. Your pump tries again to send your BG to your transmitter for sensor calibration. MP6025958-022 / A Next steps Calibrate now A BG meter reading is needed immediately to calibrate your sensor so that you can continue receiving sensor glucose readings. • Take a BG meter reading and enter for calibration. After you receive a Calibrate now alert, it takes up to 15 minutes after you calibrate for your pump to receive SG values. For details, see Calibrating your sensor, on page 183. Check BG and calibrate sensor. • If you are unable to calibrate now, you can use the Snooze feature. Set the desired time, and select Snooze. If you do not calibrate before the Snooze time is up, the Calibrate Now alert occurs again. Calibration not accepted Recheck BG and calibrate sensor. ED Your system was unable to use the BG meter readings you entered to calibrate your sensor. LE • Wash and dry hands thoroughly. See Guidelines for calibrating, on page 186. • Enter a new BG meter reading for calibration as instructed in Calibrating your sensor, on page 183. If you receive a Calibration not accepted alert on your second calibration, a Change sensor alert occurs. • Call your local representative if you have questions. Alarms, alerts, and messages 219 alarms, alerts, and messages Explanation ■ Title and text MP6025958-022 / A Title and text Explanation Next steps Cannot find sensor signal The pump has not received a signal from the transmitter. • Disconnect and reconnect your transmitter and sensor. Disconnect and reconnect transmitter, then select OK. Notice if transmitter light blinks. • See if the light on your transmitter blinks when connected to the sensor. You may need this information for troubleshooting later. • Select OK. Your pump searches for your sensor. If your pump receives a signal from your sensor, you do not need to do anything else. If your pump does not receive a signal from the sensor, another message appears to let you know. Change sensor Insert new sensor and Start New Sensor. Change sensor Second calibration not accepted. Insert new sensor. Change sensor Sensor not working properly. Insert new sensor. 220 Chapter 12 You selected No in the Check sensor insertion message, indicating that your sensor is not fully inserted. • Select OK to clear the alert. This alert occurs when you receive two Calibration not accepted errors in a row. • Select OK to clear the alert. Sensor signal is no longer reliable. • 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, on page 182. • Change your sensor. For details, see your sensor user guide. • Change your sensor. For details, see your sensor user guide. MP6025958-022 / A Title and text Explanation Next steps Check connection The pump fails to detect the transmitter and is unable to receive sensor signal. • Select OK to clear the alert. Ensure transmitter and sensor connection is secure, then select OK. • If your sensor is fully inserted, select Yes. If your sensor is not fully inserted, select No. ■ • If your sensor was not fully inserted, insert a new sensor. Transmitter signal has not been received for 30 minutes during or after initialization. Lost sensor signal Move Pump closer to transmitter. May take 15 minutes to find signal. • Move your pump closer to your transmitter. It can take up to 15 minutes for your pump to start communicating with your transmitter. ED • Select OK to clear the alert. Low battery transmitter Recharge transmitter within 24 hours. Medical device CALL FOR EMERGENCY ASSISTANCE. I have diabetes. The battery in the transmitter needs to be recharged within 24 hours. • Select OK to clear the alert. Your pump is suspended due to low SG, and you have not responded to the alarm within 10 minutes. • Select Dismiss. • Recharge your transmitter as soon as possible. • Immediately call for emergency assistance. Alarms, alerts, and messages 221 alarms, alerts, and messages • If you still cannot connect your sensor, see My pump cannot find the sensor signal, on page 234. MP6025958-022 / A Title and text Explanation Next steps No calibration occurred The transmitter was unable to receive the calibration BG meter readings from the pump. • Select OK to clear the alert. Confirm sensor signal. Calibrate by XX:XX. • Check the status bar on your pump to ensure that your pump has a signal from your sensor. If there is no sensor signal, see My pump cannot find the sensor signal, on page 234. • Calibrate again by the time shown on the pump screen to ensure you continue SG monitoring. No calibration occurred Confirm sensor signal. Check BG again to calibrate sensor. The transmitter was unable to receive the required calibration BG from the pump. • Select OK to clear the alert. • Take another BG meter reading and calibrate again. Calibration is required by the system for SG values to resume. "Calibration required" appears on your sensor graph. Possible signal interference There may be interference from • Move away from other electronic devices. It can take up to Move away from electronic devices. May take 15 minutes to find signal. another electronic device that is affecting the communication between your pump and 15 minutes for your pump to start communicating with your transmitter. transmitter. 222 Chapter 12 • Select OK to clear the alert. MP6025958-022 / A Title and text Explanation Next steps Rise Alert Your SG value has been rising as fast or faster than your preset Rise Alert Limit. • Select OK to clear the alert. Sensor alert occurred when Alert Silence is on. • Select OK to clear the alert. Sensor glucose rising rapidly. • Check the Alarm History screen to see which alerts were silenced. For more information about accessing the Alarm History screen, see Alarm History, on page 122. • Select the alert to open the Alarm Detail screen. ED • Take action based on the selected alert. Sensor connected If new sensor, select Start New. If not, select Reconnect. Insert new sensor. • If you have connected a new sensor, select Start New Sensor. The sensor has been used for 6 days (144 hours). It has reached the end of its useful life. Change your sensor. For details, see your sensor user guide. Sensor expired The transmitter has detected that you have connected a sensor. The pump needs to know if this is a new sensor or if you have reconnected your old sensor. • If you have reconnected a sensor you have been using, select Reconnect Sensor. • In either case, a "warm-up" messages appears on your Home screen, and you are prompted to calibrate your sensor. Your pump starts receiving your SG values again after the two-hour initialization is complete. Alarms, alerts, and messages 223 alarms, alerts, and messages Check Alarm History for silenced alerts. • Follow instructions from your healthcare professional. ■ Sensor alert occurred • Monitor trend and glucose level. MP6025958-022 / A Title and text Explanation Next steps Sensor signal not found The pump has still not received a signal from the transmitter. When you reconnected the transmitter to the sensor, did you see a blinking green light on the transmitter? Did transmitter light blink when connected to sensor? • Select Yes or No and follow the instructions on the screen. Sensor signal not found See User Guide. After multiple attempts, the pump failed to detect the transmitter and is unable to receive sensor signal. • Select OK to clear the alert. • Repeat the connection process. Remove the transmitter from the sensor for about ten seconds, and then reconnect it to the sensor. • It can take up to 15 minutes for your pump to find the sensor signal. • Move your pump closer to your transmitter to improve reception. • Make sure you are away from any electronic devices that might cause interference, such as cellular phones and other wireless devices. • If your pump still cannot find the sensor signal, call your local representative for assistance. SG value not available If problem continues, see User Guide. The sensor signals are either too high or too low. • Select OK to clear the alert. • You do not need to change the sensor. If the alert persists, test your transmitter with the tester. Refer to your transmitter user guide for instructions on testing the transmitter. 224 Chapter 12 MP6025958-022 / A Title and text Explanation Next steps Suspend before low Your SG value is falling. Insulin delivery is suspended according to your Suspend before low setting and your SG is approaching your specified low limit. • Select OK to clear the alert. Your SG value is at or below the low limit you specified. • Select OK to clear the alert. Transmitter battery depleted The battery in the transmitter needs to • Select OK to clear the alert. Recharge transmitter now. be recharged. SG values are not recorded or transmitted until you recharge transmitter. Delivery stopped. Sensor glucose approaching Low Limit. Check BG. • Check your BG. If necessary, treat your BG as directed by your healthcare professional. ED • Recharge your transmitter. CareLink alert and message The following table lists the most common or serious alarms, alerts, and messages related to CareLink. The table also explains the meaning, consequences, and the reasons why these notifications appear, and provides steps for problem resolution. Alarms, alerts, and messages 225 alarms, alerts, and messages Delivery stopped. Sensor glucose XXX mg/dL. Check BG. ■ Suspend on low • Check your BG. If necessary, treat your BG as directed by your healthcare professional. MP6025958-022 / A Title and text Explanation Next steps Connect Device? The CareLink USB software is attempting to connect to your pump in preparation for data download. • Select Yes to allow connection, only if you are expecting or performing a data download. The download of pump data is taking • Select OK to clear the alert. Device with SNis trying to connect to your pump. Allow connection? Download slow Insulin delivery not affected. CareLink download may take longer than usual. Select OK to continue. See User Guide. longer than expected. Data will not be affected. 226 Chapter 12 If no selection is made, the screen will timeout after 30 seconds and will automatically reject the request. • Wait for the data to finish downloading. • If problem still persists or if there • Select No to deny connection. is no progress in download, call your local representative for assistance. MP6025958-022 / A troubleshooting MP6025958-022 / A MP6025958-022 / A ■ This chapter contains procedures and information to help you understand and address conditions that might occur with your pump. For a list of alarms, alerts, and messages that may appear on your pump, see Pump alarms, alerts, and messages, on page 202. Troubleshooting pump issues WARNING: If you receive a critical error on your pump, the following screen displays and the pump sirens. Immediately disconnect from your insulin pump and discontinue use. Contact your local representative for assistance. Remember, your body still needs insulin while your pump is removed. It is important that you consult your healthcare professional to determine an alternate method of receiving insulin while your pump is removed. Troubleshooting 229 troubleshooting Troubleshooting MP6025958-022 / A 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 Startup Wizard settings. The Check Settings alarm is letting you know that other settings may have been cleared or reverted to factory default values. Review any settings that you have not already set in Startup Wizard and re-enter the values, if necessary. My pump is asking me to rewind WARNING: Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin, which may cause low BG. You always rewind your pump when changing the reservoir. Rewinding returns the piston in the reservoir compartment to its starting position. It is normal for your pump to ask you to rewind anytime you must remove and replace the reservoir, such as when resolving an Insulin Flow Blocked alarm or addressing a problem loading the reservoir. I dropped my pump Caution: If your pump has been dropped or you suspect your pump is damaged, carefully inspect your pump to ensure there are no cracks before exposing your pump to water. Do the following: 1. Check that all connections are still tightly in place. 2. Check the display, button area, and pump case for cracks or damage. 3. Check the infusion set, including the tubing connector and tubing for cracks or damage. 4. Review the status screen, basal rates and other pump settings. 5. Perform the Self Test procedure by going to: 230 Chapter 13 MP6025958-022 / A Menu > Utilities > Self Test For details, see Self Test, on page 145. 6. If the Self Test does not complete successfully, or if you are concerned about your pump, call your local representative for assistance and check your BG. I cannot get to the Manage Settings screen ■ If you go to Menu > Utilities > Manage Settings, a message appears telling you that the feature is not normally accessible and to consult your user guide. To access the Manage Settings screen: Menu > Utilities > Manage Settings 2. Simultaneously press and hold and for about two seconds. The Manage Settings screen appears. For more information, see Managing your pump settings , on page 142. My pump display times out too quickly Your pump display times out after 15 seconds by default in order to conserve battery power. You can increase this setting up to three minutes. Go to Menu > Utilities > Display Options, and then adjust the Backlight setting as desired. For more information, see Display Options, on page 141. Note: Be aware that using a longer Backlight time causes your pump to use more battery power. When your pump battery is low, the timeout for the backlight on your pump screen is automatically reduced. Where is my pump status screen? 1. To go to the Status screen, highlight and select the status bar at the top of your Home screen. Troubleshooting 231 troubleshooting 1. MP6025958-022 / A 17:00 BG 110 mg/dL Active Insulin Bolus 1.0 U Basal The Status screen appears. 2. From the Status screen, you can select the type of status information you want to view. For example, to see a quick status of your pump and recent insulin deliveries, go to Quick Status. For details, see Status screens, on page 31. My pump is asking me to L enter my settings Certain pump errors can clear your settings and return them to their factory default values. This also happens if you intentionally clear your settings. Do not clear your settings unless directed to do so by your healthcare professional. If you have saved your settings using the Save Settings option, you can restore them using the Restore Settings option. If you restore your settings, ensure the restored settings match the settings prescribed most recently by your healthcare professional. The Startup Wizard appears automatically when your pump restarts. The wizard guides you through entering the following information. Be sure to have these values ready when you begin. • Time format, time, and date • Carb unit • Active Insulin Time 232 Chapter 13 MP6025958-022 / A • Basal patterns After you enter your pump settings, you have the option of entering the following Bolus Wizard settings: • Carb ratio or Exchange ratio • Insulin sensitivity factor • BG target ■ To enter your pump settings: Begin entering your settings by selecting your language. Click Next to go to each new screen. 2. When the Select Time Format screen appears, select a 12-hour or a 24-hour time format. 3. When the Enter Time screen appears, adjust the setting to the current time. If you are using a 12-hour clock, be sure to specify AM or PM. 4. When the Enter Date screen appears, adjust the Year, Month and Day to the current date. 5. When the Select Carb Unit screen appears, select Grams or Exchanges as the unit your pump uses to display carbohydrate information. 6. When the Active Insulin Time screen appears, enter the Duration. For details, see About active insulin, on page 71. 7. Enter your first basal rate by entering the End time and the Rate. You can enter more basal patterns after you complete the startup wizard. For details, see Adding a new basal pattern, on page 42. After you complete your basal pattern, a screen appears to allow you to review your basal information. 8. When the message appears asking if you want to setup the Bolus Wizard settings, do one of the following: • Select Yes to continue entering your settings, then continue to the next section. • Select No if you do not want to enter your Bolus Wizard settings. A message appears letting you know that your settings are complete. Select OK to continue using your pump. Troubleshooting 233 troubleshooting 1. MP6025958-022 / A To enter your Bolus Wizard settings: 1. When your pump shows a list of settings for the Bolus Wizard, make sure you have the values you need before continuing. 2. Depending on the Carb Unit you set earlier, either the Carb Ratio or the Exch Ratio screen appears. Enter your carb ratio or exchange ratio by entering the End time and the Rate. You can adjust your carb or exchange ratio at any time. For details, see Changing your carb or exchange ratio, on page 69. 3. When the Edit Sensitivity screen appears, enter your insulin sensitivity factor by entering the End time and the mg/dL per unit. You can adjust your insulin sensitivity factor at any time. For details about entering insulin sensitivity factors, including how to set multiple time periods, see Changing your insulin sensitivity factor, on page 70. 4. When the BG Target screen appears, enter your BG Target range by entering the End time and your Lo (low) and Hi (high) limits. You can adjust your BG Target ranges at any time. For details, see Changing your Bolus Wizard BG target, on page 70. A message appears confirming that your setup is complete. 5. Select Next to display the Home screen, and continue using your pump. Troubleshooting sensor issues My pump cannot find the sensor signal If your pump cannot find the sensor signal after you connect your sensor and transmitter, follow the instructions on the pump screen to troubleshoot the issue as described below. If your pump finds the sensor signal at any time during troubleshooting, your pump beeps or vibrates, and "Warm up" appears on your sensor graph. It can take up to two hours for your sensor to warm up. 234 Chapter 13 MP6025958-022 / A Note: If you are using Alert Silence and currently have all sensor alerts silenced, your pump does not display the troubleshooting screens. Any glucose alerts you received are displayed in the Alarm History screen. 1. Make sure your setup meets the following requirements: • Your transmitter is fully charged. You have only one transmitter connected to your pump. Delete the current transmitter that is connected to your pump before continuing. For details, see Deleting the transmitter from your pump, on page 181. • Your transmitter is placed next to your pump. • Your transmitter is reconnected to the pump, if your pump has been recently reset. For details, see Wirelessly connecting your pump and transmitter using Auto Connect, on page 175. • The Airplane Mode is turned off on your pump. • You have applied the tape correctly, as instructed in the sensor user guide. 2. Disconnect the transmitter from the sensor for at least 10 seconds. 3. While the light on the transmitter is blinking, reconnect the transmitter with the sensor to restart communication and select OK on the pump to acknowledge the alert. 4. Depending on whether the light blinked when you connected the transmitter to the sensor, select Yes or No on your pump and do one of the following: Troubleshooting 235 troubleshooting • ■ If both lights on the charger are off, your transmitter is fully charged. For details, see your transmitter user guide. MP6025958-022 / A • If the transmitter light did not blink, you need to charge your transmitter. When your transmitter is charged, start your sensor. For details, see Starting the sensor, on page 182. • If your transmitter light blinked, but you still have no sensor signal, continue to the next step. 5. Move your pump closer to your transmitter and select OK. It can take up to 15 minutes for your pump to find the sensor signal. 6. If your pump still cannot find the sensor signal, make sure you are away from any electronic devices that might cause interference, such as cellular phones and other wireless devices, and select OK. 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 graph displays "Sensor signal not found. See User Guide," call your local representative for assistance. Calibration not accepted Calibration not accepted alert occurs when one of the following happens: • System was unable to use the BG meter readings you entered to calibrate your sensor. • System rejects two calibrations in a row from the same sensor. • The transmitter was unable to receive the calibration BG meter readings from the pump due to failed sensor signal. For details on when and how to calibrate your sensor, see Calibrating your sensor, on page 183. Why does the SmartGuard suspend by sensor icon on my Home screen appear gray? The SmartGuard suspend by sensor icon appears gray on the Home screen when either the Suspend on low or Suspend before low feature is unavailable. The suspend features may be unavailable due to the following conditions: • 236 A suspend event has occurred recently. Chapter 13 MP6025958-022 / A After a Suspend before low or Suspend on low event occurs, there is a period of time when the suspend functionality is unavailable. This time will vary depending on whether or not you respond to the suspend event. Typically, the suspend features will be unavailable for 30 minutes after your basal insulin delivery is resumed. For details, see When Suspend before low is unavailable, on page 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 your sensor, on page 183. • Your pump has lost connection to the sensor. Move your pump closer to the sensor. For more details, see My pump cannot find the sensor signal, on page 234. • The sensor glucose value received was outside the expected range and was not displayed. Select OK to clear the alert. If the issue continues, you may need to replace the sensor. If the issue persists, call your local representative for assistance. Troubleshooting 237 troubleshooting • MP6025958-022 / A 238 Chapter 13 MP6025958-022 / A maintenance MP6025958-022 / A MP6025958-022 / A ■ maintenance Maintenance Read your warranty statement included with your pump for information about what is covered during your warranty period. Cleaning your pump Caution: Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump. Never use lubricants with your pump. When cleaning your pump, be sure to keep the reservoir compartment dry and away from moisture. Make sure you have the following supplies ready for cleaning your pump: three or four small, clean, soft cloths, a mixture of water with a mild detergent, clean water, 70% alcohol, and a few clean cotton tips and cotton balls. To clean your pump: 1. Dampen a cloth with water mixed with a mild detergent. 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 battery compartment opening. Maintenance 241 MP6025958-022 / A Cleaning your transmitter Always refer to your transmitter user guide for instructions on cleaning the transmitter. Storing your pump Storage mode allows you to safely place your pump in storage while not in use. Note: If you place your pump in storage mode, it is important to insert a new AA battery for 8 to 12 hours every six months to recharge the internal power source. WARNING: Active insulin is now cleared. Any active insulin tracked prior to the pump entering storage mode is not included in any new Bolus Wizard calculations. Placing your pump in storage mode: 1. Remove the AA battery from the pump. For details, see Removing the battery, on page 23. Note: When you remove the battery, your pump issues an Insert Battery alarm for 10 minutes or until you place your pump into storage mode. 2. Press and hold until your screen turns off. Caution: Store your pump at room temperature. While in storage, the pump should never be exposed to temperatures above 35°C (95°F). Waking your pump from storage mode 1. 242 Insert a new AA battery into your pump. For details, see Inserting the battery, on page 22. Chapter 14 MP6025958-022 / A A Pump Error message appears. 2. Select OK. Your pump displays a Power Loss alarm. 3. Select OK. The Time & Date screen appears. Enter the current Time, Time Format and Date. 5. Select Save. ■ 4. 6. Select OK. Make sure that all of your settings, such as basal rate, are set as desired. If you need to, reapply your last saved settings by using the Restore Settings option as instructed in Restoring your settings, on page 143. Storing your transmitter Always refer to your transmitter user guide for instructions on storing your transmitter. Maintenance 243 maintenance Your pump displays an Active Insulin Cleared alert. MP6025958-022 / A 244 Chapter 14 MP6025958-022 / A product specifications and safety information MP6025958-022 / A MP6025958-022 / A Product specifications This section provides detailed information on product specifications. Alarm and alert escalation The following alerts may escalate to a siren: • Alert before high • Alert before low • Alert on high • Check connection • Lost sensor signal • 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 information This chapter provides detailed product specifications and safety information. ■ Product specifications and safety information MP6025958-022 / A Minutes from Audio Audio and alarm or Vibration vibration alert Audio Audio and vibrate Vibrate Audio Audio and vibrate Vibrate Audio Audio and vibrate Vibrate Audio Audio and vibrate Vibrate Audio Audio and vibrate Vibrate Audio Audio and vibrate Vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate Audio and vibrate 10 Siren and vibrate Siren and vibrate ED Siren and vibrate Note: The Medical device alarm sirens immediately. Altitude range • Pump operating range is from 70.33 kPa (10.2 psiA) to 106.18 kPa (15.4 psiA) • Storage range is from 49.64 kPa (7.2 psiA) to 106.18 kPa (15.4 psiA) Audio frequency The following table lists the various audible tones and their corresponding frequencies: Tone name Frequency tolerance (+/- 1%) Alarm 1655 Hz followed by 3310 Hz Alternate Alarm 1850 Hz Siren (escalated alarm) 1655 Hz, followed by 3310 Hz Alert 934 Hz 248 Chapter 15 MP6025958-022 / A High Sensor Glucose 1312 Hz, followed by 1410 Hz, 1500 Hz, 1619 Hz, 1722 Hz Low SG 1722 Hz, 1619 Hz, 1500 Hz, 1410 Hz, 1312 Hz Lost SG 1485 Hz, followed by 1395 Hz, 1320 Hz, 1395 Hz Message tone 1655 Hz Reminder tone 934 Hz Fill tubing tone 1850 Hz Bolus delivery cancellation tone 1485 Hz, followed by 1655 Hz and 1485 Hz Loading complete tone 934 Hz Reservoir loading in progress tone 1850 Hz Easy Bolus activation 1045 Hz Easy Bolus step 1 increment 1175 Hz Easy Bolus step 2 increment 1320 Hz Easy Bolus step 3 increment Easy Bolus step 4 increment Easy Bolus step 5 increment product specifications and safety information Frequency tolerance (+/- 1%) ■ Tone name 1395 Hz 1570 Hz 1760 Hz Backlight Type LED (Light-emitting Diode) Time out 15 seconds (default), 30 seconds, one minute, three minutes Time out when battery is low 15 seconds (default), 30 seconds Basal delivery Delivery rate range 0 to 35 units per hour or the Max Basal Rate amount, whichever is lower. Max Basal Rate default 2 units per hour Product specifications and safety information 249 MP6025958-022 / A Basal patterns Maximum of 8 patterns. Each pattern covers a 24 hour period and can have up to 48 rates. Rates are set in 30 minute increments. Basal pattern names Fixed names: Basal 1, Basal 2, Basal 3, Basal 4, Basal 5, Workday, Day Off, Sick Day Increments • 0.025 units per hour for basal amounts in the range 0 to 0.975 units • 0.05 units per hour for basal amounts in the range 1 to 9.95 units • 0.1 units per hour for basal amounts of 10 to 35 units BG Target Maximum targets Range 60 to 250 mg/dL Default value for High BG targets and Low BG targets None BG meter value The most recent BG value received from the meter. If you are using a compatible Bayer meter, this value appears on the Home screen when the Sensor feature is off. This value also appears in the Bolus Wizard screen when setting up a bolus. Expiration 12 minutes Range 20 to 600 mg/dL Bolus delivery Bolus Speed options • Standard: 1.5 units/minute • Quick: 15 units/minute Bolus programming increments • 0.025 units • 0.05 units • 0.1 units 250 Chapter 15 MP6025958-022 / A 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 settings Default Limits Increments Carb units grams Insulin to carb (or exchange) ratio None 1–200 g/u (0.075–15.0 u/exch) 0.1 g/u for 1–9.9 g/u; 1 g/u for ratios of 10 g/u to 200 g/u (0.001 u/exch for 0.075–0.099 u/exch 0.01 u/exch for 0.10–9.99 u/exch; 0.1 u/exch for 10–15 u/exch) Insulin Sensitivity Factor None 5–400 mg/dL 1 mg/dL BG Target None 60–250 mg/dL 1 mg/dL Active Insulin Time 6 hours 2 to 8 hours 15 minutes EA Bolus Wizard featureR specifications There are four different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current BG. The following formulas apply only when the carb units are in grams. 1. If your current BG is greater than your High BG Target, the Bolus Wizard feature subtracts active insulin from the BG correction estimate, then adds this to the food estimate to get the total bolus estimate. However, if the result of subtracting active insulin from BG correction estimate is a negative number (less than zero), the total bolus estimate is based only on the food estimate. Product specifications and safety information 251 product specifications and safety information ■ Item MP6025958-022 / A (food estimate) total bolus estimate = (correction estimate) C-D - active insulin where: A = food (grams) B = carb ratio C = current BG D = High BG Target E = insulin sensitivity Food estimate: Carb grams ÷ Carb ratio = Units of insulin Correction estimate: (Current BG - High BG Target) ÷ Insulin sensitivity - Active insulin = Units of insulin Total bolus estimate: Food estimate + Correction estimate = Units of insulin 2. If your current BG is less than your Low BG Target, the Bolus Wizard feature adds the BG correction estimate to the food estimate to get the total bolus estimate. (food estimate) total bolus estimate = (correction estimate) C-D where: A = food (grams) B = carb ratio C = current BG D = Low BG Target E = insulin sensitivity Food estimate: Carb grams ÷ Carb ratio = Units of insulin Correction estimate: (Current BG - Low BG Target) ÷ Insulin sensitivity = Units of insulin Total bolus estimate: 252 Chapter 15 MP6025958-022 / A Food estimate + Correction estimate = Units of insulin 3. If your current BG is between or equal to your High or Low BG Target, the total bolus estimate is based only on the food estimate. (food estimate) food (grams) ■ total bolus estimate = carb ratio Carb grams ÷ Carb ratio = Units of insulin Note: When the current BG is below the Low BG Target, an active insulin amount is not considered in the Bolus Wizard feature calculations. Total bolus estimate = Food estimate 4. If you do not enter a BG, the total bolus estimate is based only on the food estimate. Following are some notes about using the Bolus Wizard: • If a Dual Wave bolus is less than the estimate due to the Max Bolus limit or a change that you make, the Square portion is reduced first. • Based on the Active Insulin Time setting you choose, your pump keeps track of how much insulin is still active in your body. This is shown as Active Insulin or Act. Ins. on the Home screen, Bolus screen, Manual Bolus screen, Preset Bolus, and Daily History screens. This prevents stacking of insulin, and lowers the chances of hypoglycemia. • The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, and active insulin to calculate your estimated bolus. • Active Insulin Curve Product specifications and safety information 253 product specifications and safety information Food estimate: MP6025958-022 / A Active Insulin Curve 100% 90% 8 Hour 80% 7 Hour 6 Hour 5 Hour % Insulin Remaining 70% 4 Hour 3 Hour 2 Hour 60% 50% 40% 30% 20% 10% 0% Time (hours) Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501. Carb ratios Maximum ratio settings Range 1 to 200 grams/unit 0.075 to 15 units/exch Delivery accuracy • Delivery accuracy: ±5%. • All Normal boluses are delivered within 50 minutes ±3 seconds at Standard rate (75 units, at 1.5 units per minute), and within 5 minutes ±3 seconds at Quick rate (75 units, at 15 units per minute). • The maximum infusion pressure generated and the occlusion threshold pressure is 86.12 kPa (12.49 psi). The bolus volume generated is 0.01225 mL. • The following is a representative delivery accuracy curve. 254 Chapter 15 MP6025958-022 / A Trumpet Curve for MMT−1511/1512 25 20 10 ■ product specifications and safety information Percent Error [%] 15 −5 −10 −15 −20 10 30 20 40 50 60 Overall Error Maximum Error Minimum Error 70 80 90 100 Observation Window [Minutes] Easy Bolus Allows user to set up and deliver a Normal Bolus when the pump is in Sleep Mode. 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, whichever comes first Vibrate mode range 0 to 20 increments or Max Bolus limit, whichever comes first Default step size 0.1 unit Adjustable step size 0.1 to 2 units per increment up to Max Bolus limit Environmental conditions • 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 255 MP6025958-022 / A • 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 of 0.025 units. • The standard fill rate is 1.5 units per minute. The quick fill rate is 15 units per minute. • When filling the tubing, a warning occurs at 30 units, and thereafter at every 10 units. • Insulin used to fill the infusion set is recorded in the Daily History. Infusion pressure The maximum infusion pressure and occlusion pressure is 86.12 kPa (12.49 psi). Insulin delivery default settings Bolus settings EA Item Default setting Limits Increments Bolus Wizard feature: Off Easy bolus: Off Easy bolus step size: 0.1 U 0.1 U to 2 U Bolus increment: 0.10 U 0.025 U 0.05 U EL 0.10 U Dual/Square bolus: Off Max bolus: 10 U 0 to 75 U (per single bolus) Bolus BG Check Reminder: Off 0:00 to 5:00 0:30 256 Chapter 15 MP6025958-022 / A Basal settings Limits Increments Max Basal Rate 2 U/h 0–35 U/h 0.025 U for 0.025–0.975 U/h 0.05 U for 1.00–9.95 U/h 0.1 U for rates of 10.0 U/h or more Basal Rate 0.000 U/h 0.000 U/h to Max Basal Rate setting 0.025 U for 0.025–0.975 U/h 0.05 U for 1.00–9.95 U/h 0.1 U for rates of 10.0 U/h or more Temp Basal Type Percent Percent, Rate N/A Temp Basal Percent 100% 0-200% 5% Temp Basal Rate Current basal rate 0.0 U/hr to Max Basal Rate ED 0.025 U for 0.025–0.975 U/h 0.05 U for 1.00–9.95 U/h 0.1 U for rates of 10.0 U/h or more Insulin sensitivity factor Maximum settings Default None. Insulin sensitivity is set during Startup of the Bolus Wizard. Range 5 to 400 mg/dL/unit Low Reservoir reminder The values are based on displayed amount, not actual amount. Product specifications and safety information 257 product specifications and safety information Default setting ■ Item MP6025958-022 / A Alert Alert range Increment type Default value Time First reminder occurs at 2 to 24 hours. Second reminder occurs one hour before empty. The 30 min 8 hours 1 unit 20 units second reminder is automatic and cannot be changed by the user. Units First reminder occurs at 5 to 50 units. Second reminder occurs at 50 percent of the remaining specified amount. The second reminder is automatic and cannot be changed by the user. Max Bolus Range 0 to 75 units Default 10 units Normal bolus Range is 0.025 to 75 units of insulin, and limited by the Max Bolus setting. Occlusion detection When occlusion is detected, the Insulin flow blocked alarm occurs. The occlusion alarm is triggered by an average of 2.23 units of missed insulin (standard bolus) or 1.97 units of missed insulin (quick bolus). The MiniMed pump is intended for use with U100 insulin. This table shows occlusion detection for four different situations when using U100 insulin. Rate Minimum time Average time Maximum time before alarm before alarm before alarm bolus delivery (10 units at standard speed) 71 seconds 95 seconds 136 seconds bolus delivery (10 units at quick speed) 9 seconds 10 seconds 14 seconds basal delivery (1.0 u/h) 2.00 hours 2.50 hours 3.80 hours basal delivery (0.025 u/h) 123.38 hours 142.03 hours 178.33 hours 258 Chapter 15 MP6025958-022 / A Percent temp basal The default value is 100 percent of basal programming. Range 0 to 200% Default 100% of basal programming Increment 5% ■ A single fault condition will cause the pump to suspend insulin delivery. Maximum infusion with a single fault condition is 0.2 units. Pump dimensions The MMT-1512 pump dimensions in inches are approximately 2.1 width x 3.34 length x 0.96 depth. The MMT-1512 pump dimensions in centimeters are approximately 5.3 width x 8.5 length x 2.44 depth. The MMT-1712 pump dimensions in inches are approximately 2.1 width x 3.78 length x 0.96 depth. The MMT-1712 pump dimensions in centimeters are approximately 5.3 width x 9.6 length x 2.44 depth. Pump memory User settings and pump history are stored in non-volatile memory which will retain data. The memory size will hold 90 days of pump history before it becomes full and has to be written over. This means that at any time the user can review a maximum of 90 days of history. Pump weight The mass of the MiniMed 640G insulin pump (MMT-1512) is approximately 91.9 grams. The mass of the MiniMed 640G insulin pump (MMT-1712) is approximately 95.7 grams. Product specifications and safety information 259 product specifications and safety information Program safety checks MP6025958-022 / A Sensor default settings High sensor settings Item Default Limits Increments setting High SG alert limit 250 mg/dL 100 to 400 mg/dL 5 mg/dL Alert before high Off Alert on high Off Time before high 15 minutes 5 to 30 minutes 5 minutes Rise Alert Off Rise Limit Two up arrows • 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 Item 1 hour Default 5 minutes to 3 hours 5 minutes Low sensor settings Limits Increments setting Low SG alert limit 60 mg/dL 50 to 90 mg/dL 5 mg/dL Suspend before low Off Suspend on low Off Alert before low Off Alert on low Off Low Snooze 20 minutes 5 minutes to 1 hour 5 minutes 260 Chapter 15 MP6025958-022 / A Low sensor settings Item Default Limits Increments setting Resume basal alert Off ■ product specifications and safety information Product specifications and safety information 261 MP6025958-022 / A Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the MiniMed insulin pump should make sure that it is used in such an environment. Emissions Test Compliance RF emissions • 6 dB and 99% Bandwidths: Pass Test: 47 CFR Part 15, Subpart C Section 15.247(a)(2)/RSS-210 FHSS– DAOO-705, DTS-KDB 558074, ANSI C63.4, RSS-Gen, FCC Part 15 Section 15.109, Class B/ANSI c63.4 (2009) • Maximum Output Power: Pass RF emissions Class B EN55011 (2009)+A1 RTCA DO 160G (2010) 20.5 and 21.5 ARIB STD-T66 262 Chapter 15 • TX Spurious Emissions: Pass • Power Spectral Density: Pass Complies Complies The MiniMed insulin pump must emit electromagnetic energy in order to perform its intended function. Nearby electronic equipment may be affected. Electromagnetic Environment Guidance The MiniMed insulin pump is suitable for use in all establishments, including domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. MP6025958-022 / A Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below. The customer or the user of the MiniMed insulin pump should assure that it is used in such an environment. Immunity Test ±15 kV air IEC 61000-4-2 Electrical fast transient/ burst ±2 kV for power supply lines IEC 61000-4-4 ±1 kV for input/ output lines Surge ±1 kV line(s) to line(s) IEC 61000-4-5 ±30 kV air (<5% relative humidity) For use in a typical domestic, commercial, or hospital environment. Not applicable Requirement does not apply to this battery powered device. ED Not applicable Requirement does not apply to this battery powered device. Not applicable (>95% dip in UT Requirement does not apply to this battery ) for 0.5 cycle powered device. ±2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply lines Electromagnetic Environment Guidance <5% UT IEC 61000-4-11 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 400 A/m (continuous field at 60 seconds) 400 A/m 4000 A/m (short duration at 3 seconds) 4000 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note: UT is the a.c. mains voltage prior to application of the test level. Product specifications and safety information 263 product specifications and safety information ±8 kV contact Compliance Level ■ Electrostatic discharge (ESD) IEC 60601 Test Level MP6025958-022 / A Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below. The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment. Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the MiniMed insulin pump, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. 264 Chapter 15 MP6025958-022 / A Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below. The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment. IEC 61000-4-3 80 MHz to 800 MHz 10 V/m 80 MHz to 800 MHz 10 V/m 800 MHz to 2.5 GHz 10 V/m 800 MHz to 6 GHz Recommended separation distance d = [12/E1] P 80 MHz to 800 MHz d = [23/E1] P 800 MHz to 6 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). EA EL Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol: Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption, and reflection from structures, objects and people. Note: The table is per IEC (EN) 60601-1-2 Edition 3. Product specifications and safety information 265 product specifications and safety information 10 V/m ■ Radiated RF MP6025958-022 / A Guidance and Manufacturer's Declaration - Electromagnetic Immunity The MiniMed 640G insulin pump is intended for use in the electromagnetic environment specified below. The customer or user of the MiniMed insulin pump should assure that it is used in such an electromagnetic environment. aField strengths from fixed transmitters, such as base stations for radio (cellular/ cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the MiniMed insulin pump is used exceeds the applicable RF compliance level above, the insulin pump should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the MiniMed insulin pump. bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. 266 Chapter 15 MP6025958-022 / A Recommended separation distances between the MiniMed 640G insulin pump and common household radio transmitters Household RF Transmitter Frequency Recommended Separation Distance (meter) Recommended Separation Distance (inch) Cordless Household 2.4 GHz 0.3 12 Cordless Household 5.8 GHz 0.3 12 TDMA-50 Hz (cell phone) 1.9 GHz 0.3 12 TDMA-50 Hz (cell phone) 800 MHz 0.3 12 PCS (cell phone) 1.9 MHz 0.3 12 DCS (cell phone) 1.8 MHz 0.3 12 GSM (cell phone) 900 MHz 0.3 12 GSM (cell phone) 850 MHz 0.3 12 CDMA (cell phone) 800 MHz 0.3 12 Analog (cell phone) 824 MHz 0.3 12 CDMA (cell phone) 1.9 MHz 0.3 12 2.4 GHz 39.5 802.11g 2.4 GHz 39.5 802.11n 2.4 GHz 39.5 Bluetooth 500 kb/s 2.4 GHz 0.1 3.93 ZigBee 250 kb/s 2.4 GHz 0.1 3.93 Telephones Product specifications and safety information product specifications and safety information 802.11b ■ WiFi Networks 267 MP6025958-022 / A Recommended separation distances between portable and mobile RF communications equipment and the MiniMed 640G insulin pump The insulin pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the MiniMed insulin pump can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the MiniMed insulin pump as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W) Separation distance according to the frequency of transmitter (m) 80 MHz to 800 MHz 800 MHz to 6 GHz d=1.2 P d=2.3 P 0.01 0.12 0.23 0.1 0.38 0.73 1.2 2.3 10 3.8 7.3 12 23 ED 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Wireless communication Quality of service The CGM transmitter and MiniMed insulin pump are associated as part of an 802.15.4 network for which the pump functions as the coordinator and the CGM transmitter as an end node. In an adverse RF environment the MMT-1512/1712 pump will assess channel changing needs based on "noise" levels detected during 268 Chapter 15 MP6025958-022 / A an energy scan. The pump will perform the energy scan if after 10 minutes no CGM transmitter signal has been received. If the channel change occurs the pump will send beacons on the new channel. product specifications and safety information In normal operation the CGM transmitter will transmit a packet every 5 minutes and retransmit the packet if the data is corrupted or missed. Radio frequency (RF) communications specifications Utilizes the IEEE 802.15.4 protocol with the proprietary data format. Pump frequency 2.4 GHz; proprietary Medtronic protocol; range up to 1.8 meters (6 feet). Maximum output power (EIRP) -1.59 dBm Operating frequencies 2420 MHz, 2435 MHz, 2450 MHz, 2465 MHz, 2480 MHz Bandwidth 5 MHz which is allocated channel bandwidth per the IEEE protocol Data security The MiniMed 640G insulin pump is designed to only accept radio frequency (RF) communications from recognized and linked devices (you must program your pump to accept information from a specific device). The MiniMed 640G system ensures data security via proprietary means and ensures data integrity using error checking processes, such as cyclic redundancy checks. Product specifications and safety information ■ The CGM transmitter will initiate a channel search when beacon detection fails on the associated channel. The search will be conducted across all five channels. When the beacon is located the transmitter will rejoin on the identified channel. Upon re-association any missed packets (up to 10 hours) will be transmitted from the CGM transmitter to the pump. 269 MP6025958-022 / A Icon table Follow instructions for use Manufacturer Date of manufacture (year - month) Use by (year - month) Catalogue number Device serial number Storage temperature range Storage humidity range Magnetic Resonance (MR) unsafe Type BF equipment (protection from electrical shock) Radio communication Pump: Protected against the effects of continuous immersion in water (12 feet or 3.6 meters for 24 hours). Signifies compliance with Australian EMC, EME and Radio communications requirements Signifies compliance with Industry Canada EMC and Radio communications requirements This symbol means that the device fully complies with MDD 93/42/EEC (NB 0459) and R&TTE Directive 1999/5/EC. 270 Chapter 15 MP6025958-022 / A appendix a: end user software license agreement MP6025958-022 / A MP6025958-022 / A ■ End user software license agreement NOTICE TO USER: Certain portions of software contained in this product may be covered by the GNU General Public License, Version 2 or Version 3 (“Open Source”), which can be obtained through the GNU web site at www.gnu.org/copyleft/ gpl.html. The source code for any Open Source can be obtained, for a nominal fee to cover the cost of shipping and media, by contacting Medtronic MiniMed, Inc., Director of Software Development, 18000 Devonshire Street, Northridge, CA 91325-1219, USA, tel: +1-866-948-6633. End user software license agreement 273 appendix a: end user software license agreement End user software license agreement MP6025958-022 / A 274 Appendix A MP6025958-022 / A glossary MP6025958-022 / A MP6025958-022 / A ■ glossary Glossary active insulin Bolus insulin that has been delivered by the pump and is still working to lower your blood glucose levels. active insulin adjustment The amount of insulin that is subtracted from your BG correction bolus to account for the active insulin that is tracked by the Bolus Wizard. Active Insulin Time A Bolus Wizard setting that lets you set the length of time that bolus insulin is tracked as active insulin. Activity Guard An attachment that can be used to ensure that the reservoir stays secure during activity, or when the pump is worn by a child. Airplane Mode A feature that temporarily stops your device from communicating wirelessly. alarm An audible beep or vibration with a message to inform you that the pump is no longer delivering insulin. Alarms require immediate action. Alarm History A feature that stores information about recent alarms and alerts. alert An audible beep or vibration with a message to inform you of a situation that may require your attention. Alert before low An alert that occurs when you are approaching your low sensor glucose value. Alert Limits The values that you set to determine when low and high glucose alerts are triggered. Glossary 277 MP6025958-022 / A Alert on low An alert that occurs when your sensor glucose value reaches or falls below your low limit. Auto Suspend An alarm that you set to suspend insulin delivery and trigger an alarm if no buttons are pressed for a specified period of time. Clearing the alarm resumes insulin delivery. Awake mode A state in which the pump screen is on. Unless you are actively using another screen, your Home screen appears. basal insulin Insulin that is continuously delivered by the pump to meet your individual insulin needs between meals and during sleep. basal pattern A set of one or more basal rates that covers a 24-hour period. basal rate The amount of continuous basal insulin that you program 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 is corrected when using the Bolus Wizard. Block Mode A feature that restricts the ability to change all settings. You can still perform certain functions, such as suspending insulin delivery, reviewing history, testing your pump, or clearing alarms and alerts. 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 glucose when the time period that you specified has passed. bolus insulin Insulin used to cover an expected rise in glucose levels from carbohydrates, or to lower a high blood glucose value down to your target range. Bolus Speed A feature that lets you choose the speed at which your device delivers bolus insulin. 278 Glossary MP6025958-022 / A A feature that uses your individual Bolus Wizard settings to calculate an estimated bolus amount based on the BG values and carbs that you enter. These settings include Carb Ratio, Insulin Sensitivity Factor, BG Target Range, and Active Insulin Time. calibrate The process of using a meter blood glucose reading to calculate sensor glucose values. Calibration reminder A reminder you can set to let you know when your next calibration is due. cannula Short, thin, and flexible tube placed in the tissue below the skin. Insulin is delivered through the cannula into the body. carb ratio The number of grams of carbohydrates covered by one unit of insulin. The carb ratio is used to calculate bolus amounts. carb unit The unit of measure for carbohydrates, either grams (g) or exchanges (exch). CGM Abbreviation for continuous glucose monitoring. See continuous glucose monitoring. continuous glucose monitoring (CGM) A monitoring tool that uses a glucose sensor placed below the skin to continuously measure the amount of glucose in your interstitial fluid. correction bolus Insulin used to lower a high blood glucose value down to your target range. Daily History A feature that displays the actions that you performed using your device. Dual Wave™ Bolus A type of bolus that provides a dose of insulin delivered as a combination of a Normal Bolus followed by a Square Wave Bolus. Easy Bolus™ A feature that lets you deliver a Normal Bolus in preset increments using only audio or vibrate confirmation. Event Marker A feature that allows you to record events, such as blood glucose readings, injections, carbohydrates, and exercise. Glossary 279 ■ glossary Bolus Wizard MP6025958-022 / A exchange ratio The number of insulin units that are needed to cover 1 carbohydrate exchange. The exchange ratio is based on your individual needs and is used to calculate bolus amounts. food bolus A dose of insulin you give to cover an expected rise in glucose levels from carbohydrates. High limit The value you set to determine when the pump will alert you of a high sensor glucose condition. infusion set Tubing that connects to the reservoir on one end, and has a needle or cannula on the other end, that you insert into your body. Insulin travels from the pump through the infusion set into your body. infusion site The location on the body where the infusion set is inserted. insulin sensitivity factor The amount that blood glucose is reduced by one unit of insulin. The insulin sensitivity factor is used to calculate 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 calculate your sensor glucose value. Typically used by Medtronic technical support representatives when troubleshooting. lock A pump feature that prevents accidental button presses. Low limit The value you set to determine when the pump will alert of a low sensor glucose condition, and also used for determining if insulin delivery should be suspended. Manual Bolus A feature that allows you to enter and deliver a dose of insulin in the amount that you have determined is necessary. Max Basal Rate A feature that allows you to set the maximum amount of basal insulin that can be delivered per hour. Max Bolus A feature that allows you to set the maximum bolus amount that can be delivered in one dose. meter A term for any blood glucose meter. 280 Glossary MP6025958-022 / A A reminder that a bolus was not delivered during time periods that you specify, often set around your meal times. Normal Bolus A type of bolus that provides an entire dose of insulin immediately. notifications All notifications are designed to get your attention and convey different types of information. They include alarms, alerts, reminders, and messages. occlusion A blockage or crimp of the cannula or tubing that prevents proper insulin flow. piston The part of the insulin pump that engages the reservoir and moves insulin through the tubing. Power save mode A state in which your pump is fully functional, but the screen goes dark to save power. You can set how long it takes for your screen to enter power save mode by changing the Backlight setting. Preset Bolus A feature that allows you to set up and save a bolus for specific meals or snacks that you frequently eat or drink. Preset Temp Basal A feature that allows you to set up and save temporary basal rates for repeated use. Rate alert ■ glossary Missed Meal Bolus reminder An alert that notifies you if your sensor glucose value has been rising or falling faster than the Rise Limit or Fall Limit that you have set. reminder A type of notification that you can set to help you remember to do something. reservoir The small container that you fill with insulin and insert into your delivery device. Resume basal alert An alert that can be set to occur when your pump has automatically resumed basal insulin delivery after a Suspend before low or Suspend on low event because your sensor glucose values have met the necessary criteria. This alert will always occur if basal insulin delivery has resumed because the two hour maximum suspend time has elapsed. Glossary 281 MP6025958-022 / A Rewind A feature used when changing a reservoir. It returns the piston to its starting position and allows a new reservoir to be placed into the pump. sensitivity See insulin sensitivity factor. sensor (glucose sensor) The small part of the continuous glucose monitoring system that you insert just below your skin to measure glucose levels in your interstitial fluid. sensor glucose (SG) Refers to glucose (sugar) that is present in the interstitial fluid 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 the screen is dark. Your pump automatically enters sleep mode when you have not pressed any buttons for about two minutes. SmartGuard™ A feature that can automatically stop and resume insulin delivery based on your sensor glucose values and low limit. Square Wave™ Bolus A bolus delivered evenly over a specified time period. Suspend before low A feature that suspends insulin delivery when the sensor predicts sensor glucose value is approaching your low limit. 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 your sensor glucose value reaches or falls below your low limit. Temp Basal Rate (temporary basal rate) A feature that allows you to temporarily increase or decrease your current basal rate for a duration of time that you specify. transfer guard The plastic piece that comes attached to the reservoir. It is used to connect the reservoir to the insulin vial while filling the reservoir with insulin. 282 Glossary MP6025958-022 / A transmitter A device that connects to a glucose sensor. The transmitter collects data measured by the sensor and wirelessly sends this data to monitoring devices. ■ glossary Glossary 283 MP6025958-022 / A 284 Glossary MP6025958-022 / A index MP6025958-022 / A MP6025958-022 / A ■ Index accessories 15 active insulin about 71 adjustment 71 clearing settings 144 Home screen 26 injection warning 71 viewing amount 27 Active Insulin cleared alert 202 Active Insulin Time about 66 changing 71 Airplane Mode setting up 138 status bar 29 using 137 Alarm History 122 alarms about 199 audio options 201 Auto Suspend 203 Battery failed 203 Battery not compatible 203 Bolus not delivered 203 Bolus stopped 203 CGM 216 Critical pump error 204 Delivery limit exceeded 205 emergency siren 201 Fill Cannula? 205 Insert battery 205 Insulin flow blocked 206, 207, 208, 209 Loading incomplete 209 Manage Settings error 210 Max Fill reached 210, 211 No reservoir detected 211 notification light 200 overview 200 pump 202, 225 Pump error 212, 213 Pump restarted 213 red icon 200 Replace battery 213 Replace battery now 214 sensor 216 siren 201 Stuck button 215 Alert before high SG setting 156 Alert before low about 160 summary screen 120 Alert on high SG setting 156 Alert on low about 163 summary screen 120 Alert Silence 193 alerts about 199 Active Insulin cleared 202 audio options 201 BG not received 218 Calibrate now 219 Calibration not accepted 219 Cannot connect device 204 Index 287 index MP6025958-022 / A Cannot find sensor signal 220 CGM 216 Change sensor 220 Check connection 221 Check settings 204 Download slow 226 Lost sensor signal 221 Low battery Pump 209 Low battery transmitter 221 Low reservoir 210 No calibration occurred 222 notification light 201 overview 201 Possible signal interference 222 pump 202, 225 Reservoir estimate 214 Rise alert 223 sensor 216 Sensor alert occurred 223 Sensor expired 223 Sensor signal not found 224 SG value not available 224 silencing 193 Transmitter battery depleted 225 yellow icon 201 areas, for inserting infusion set 103 arrows, trend 192 audio options 33 settings 138 silencing 193 vibrate 29 auto connect 175 Auto Suspend alarm 203 awake mode 34 backlight battery use 21 setting up 141 basal about 39 current delivery 52 288 Index daily delivery amount 118 delivery 39 history 117, 118 Home screen 26 Max Basal Rate 41 patterns 41 Preset Temp basal rate 49 rate 39 settings 40 summary 117 Temp Basal 47 basal patterns about 42 adding 46 changing 46 deleting 46 example 42 battery about 21 alarm 203, 205, 213, 214 alert 209 belt clip 23 compartment location 19 disposal 23 inserting 22 removing 23 replacing 22 status bar icon 28 types 21 Battery failed alarm 203 Battery not compatible alarm 203 belt clip part number 15 remove battery cap 23 BG Home Screen 26 sensor calibration 185 BG meter readings average 119 manual high 120 manual low 120 meter high 120 meter low 119 summary 119 MP6025958-022 / A bolus types DualWave 60 examples 60 Normal 59 Square Wave 60 Bolus Wizard Active Insulin Time 66 BG target 66 Carb ratio 65 Dual Wave 79 Exchange ratio 65 High BG warning 72 injection warning 71 Insulin Sensitivity Factor 65 Low BG warning 72 Max Bolus Exceeded warning 73 Normal bolus 73 Square Wave 77 warnings 72 CD ■ index BG not received alert 218 BG target Bolus Wizard 66 setting up 70 Block Mode status bar 31 using 139 blood glucose Home screen 26 sensor calibration 185 bolus about 59 daily delivery amount 118 delivery speed 63 history 117, 118 increment setting 63, 64 Max bolus 62 reminders 131 setting delivery speed 63 settings 62 summary 117, 118 types 59 Bolus BG Check reminder, about 130 bolus deliveries about 59 Bolus Wizard 61, 65 delivery rate 63 Dual Wave 79 Easy Bolus 62, 82 Manual Bolus 61, 75 Max Bolus setting 62 Normal bolus 73, 75 options 61 Preset Bolus 61, 85 resume message 214, 215 Square Wave 76 stopping 88 types 59 Bolus not delivered alarm 203 Bolus stopped alarm 203 calibrate error 220, 221 sensor 183 when to 186 Calibrate now alert 219 calibration guidelines 186 icon 30 Calibration not accepted alert 219 Calibration reminder 133 Cannot connect device alert 204 Cannot find sensor signal alert 220 cannula alarm 205 carb ratio 69 Carb Units 140 CareLink Personal Software 124 Change sensor alert 220 Check connection alert 221 Check settings alert 204 cleaning pump 241 transmitter 242 Index 289 MP6025958-022 / A clearing active insulin 144 pump settings 143 Connect Device message 226 connecting pump, transmitter automatically 175 manually 178 connection, failure 178 Consumable infusion set 13 reservoir 13 continuous glucose monitoring about 151 airplane mode 137 alarms 216 alerts 216 calibrating sensor 183 connecting pump, transmitter 175 examples 164 High Settings 156 home screen 152 Low Settings 157 messages 216 sensor feature, turning on 167 sensor glucose reading 191 sensor graph 191 settings 155 correction estimate 251, 252 Critical pump error 204 example 60 Manual bolus 81 resume message 214, 215 setting up 79 Daily History 121 date changing 148 Startup Wizard 24 delivery stop bolus 33 suspend all 33 Delivery limit exceeded alarm 205 Download slow alert 226 Dual Wave 60 about 79 Bolus Wizard 79 290 Index Easy bolus about 82 Manual bolus 84 setting up 83 step size 83 electromagnetic emissions 262 Electromagnetic environment 267, 268 electromagnetic immunity 263 emergency kit 4 siren 201 emergency kit 4 emissions 262 event markers about 124 blood glucose 125 exercise 125 food 125 injection 125 setting up 124 exchange ratio 69 Fill Cannula? alarm 205 food estimate 251, 252, 253 glucose alerts, silencing 193 graph, sensor 191 High BG, Bolus Wizard warning 72 High Limit SG setting 156 High Settings about 156 entering 167 MP6025958-022 / A icons Home Screen 28 sensor status 152 SmartGuard 155, 159, 162 suspend by sensor 155 infusion set about 93 best insertion sites 103 disconnect Quick-set 107 fill cannula alarm 205 fill tubing 101 inserting 103 reconnect Quick-set 107 reservoir alarm 209 reservoir and tubing 33 reservoir removal 93 rotating sites 104 setting up 93 type 13 Insert battery alarm 205 inserting infusion set 103 reservoir 99 sensor 181 insulin basal 39 basal patterns 41 bolus 59 flow blocked alarm 206, 207, 208, 209 icon 29 Max Fill reached alarm 210, 211 settings 33 insulin delivery Block Mode 139 resuming 54, 163, 174 stopping 54, 88 suspending 54, 139, 158, 161 Insulin flow blocked alarm 206, 207, 208, 209 Insulin Sensitivity Factor about 65 setting up 70 ISIG view 124 language changing 141 starting 24 light, red 200 Loading incomplete alarm 209 Lost sensor signal alert 221 Low battery Pump alert 209 Low battery transmitter alert 221 Low BG, Bolus Wizard warning 72 Low limit 158 Low Reservoir alert 132, 210 reminder 132 Low Settings about 157 entering 171 examples 164 Index 291 ■ index history about 117 menu 33 pump settings, viewing 145 summary 117 Home Screen about 26 active insulin amount 26 basal delivery 26 blood glucose reading 26 bolus delivery 26 CGM, with 152 display 21 sensor glucose 152 sensor glucose reading 152 sensor graph 152 sensor status icons 152 status bar 26 time 26 trend arrows 152 MP6025958-022 / A maintenance 241 Manage Settings error alarm 210 managing, pump settings 142 Manual bolus Dual Wave 81 Easy bolus 84 Normal bolus 75 Square Wave 78 Max Basal alarm 205 rate 40 Max Basal Rate setting 41 Max Bolus alarm 205 exceeded 73 setting 62 warning 63 Max Fill reached alarm 210, 211 Menu screen about 32 accessing 32 audio options 33 display 21 event markers 33 history 33 insulin settings 33 reminders 33 reservoir and tubing 33 sensor settings 33 suspend delivery 33 utilities 33 messages about 199 audio options 202 blue icon 202 CGM 216 Connect Device 226 continuous glucose monitoring 216 overview 202 pump 202, 225 Resume bolus 214 Resume Dual bolus 214, 215 Resume Square bolus 215 sensor 216 Sensor connected 223 Missed Meal Bolus reminder 131 modes Block 139 power 34 mute alerts 193 292 Index No calibration occurred alert 222 No reservoir detected alarm 211 Normal bolus about 73 Bolus Wizard 73 delivery 73 example 60 Manual bolus 75 resume message 214 notification light 200, 201 notifications 31 ordering supplies 15 patterns, basal about 42 adding 46 changing 46 copying 46 deleting 46 example 42 personal reminder 129 Possible signal interference alert 222 power save mode 34 Preset Bolus about 85 changing 86 deleting 86 delivering 87 MP6025958-022 / A Quick-set infusion set disconnecting 107 reconnecting 108 quick status 31 rate, basal about 39 Preset Temp 40 Temp 40, 47 rate of change arrows 152 red light 200, 201 reminders about 129 Bolus BG Check 130 Calibration 133 Low Reservoir 132 Menu screen 33 Missed Meal Bolus 131 Personal 129 Set Change 133 remote bolus 62, 112 Replace battery alarm 213, 214 reservoir about 93 compartment image 19 inserting 99 Loading incomplete alarm 209 Low Reservoir alert 210 Max Fill reached alarm 210, 211 Menu screen 33 No reservoir detected alarm 211 ordering 15 plunger rod 97 removal 93 Reservoir estimate at 0 U 214 setting up 93 transfer guard 97 type 13 Reservoir estimate alert 214 restoring, pump settings 143 Resume basal alert 163, 164 Resume bolus message 214 Resume Dual bolus message 214, 215 ■ index Dual Wave 85 renaming 86 setting up 85 Square Wave 85 Preset Temp Basal rate about 40 starting 51 Preset Temp basal rate about 49 editing 50 managing 49 setting up 49 previous screen 21 pump alarms 202, 225 alerts 202, 225 buttons 20 cleaning 241 connecting, transmitter 175, 178 connection status 29 deleting, transmitter 181 messages 202, 225 navigation 24 notification light 20 overview 19 parts illustration 19 rewinding 94 settings 232 storing 242 unlocking 26 Pump error alarm 212, 213 Pump restarted alarm 213 pump settings clearing 143 managing 142 restoring 143 saving 142 specifications 247 viewing history 145 Index 293 MP6025958-022 / A Resume Square bolus message 215 resuming suspended delivery 54, 163, 174 return to previous screen 21 RF communications 267, 268 Rise Alert responding to 223 SG setting 157 summary screen 120 Rise Limit SG setting 157 saving power 34 pump settings 142 screen Active Insulin Time 71 Airplane Mode 138 Alarm History 122 Audio Options 139 Auto Suspend 139 Basal Pattern Setup 46 BG Check 130 BG Target 70 Block Mode 140 Bolus Increment 64 Bolus Speed 64 Bolus Wizard Setup 66, 71 Carb Ratio 69 Carb Unit 140 Display Options 141 Dual/Square Wave 77 Easy Bolus 83 Enter Date Screen 25 Enter Time 25 Event Markers 124 Exchange Ratio 69 Fill Cannula 106 Fill Tubing 102 Home Screen 26, 152 Language 24, 141 Low Reservoir 133 Manual bolus 75 Max Bolus 63 294 Index Missed Meal Bolus 131 New Reservoir 95 Personal reminder 129 Preset Bolus Setup 86 Preset Temp Setup 50 Select Time Format 24 Self Test 146 Sensitivity 70 Sensor Demo 147 Sensor Glucose Review 122 Sensor Settings 167 Set Change 133 Summary 117 Suspend Delivery 54 Temp Basal 48 Time and Date 148 Welcome screen 24 scroll bar 21, 34 select 21 sensor airplane mode 137 alarms 216 alerts 216 BG not received alert 218 calibrating 183, 186 calibration alert 219 calibration icon 30 connecting, transmitter 182 disconnecting, transmitter 187 expired alert 223 feature, turning off 187 feature, turning on 167 graph 152 inserting 181 life icon 30 messages 216 pair 175, 178 removing 187 settings 33, 167 signal alert 220 starting 182 status icons 152 MP6025958-022 / A Square Wave 60 about 76 Bolus Wizard 77 example 60 Manual bolus 78 resume message 214, 215 setting up 76 starting sensor 182 Startup Wizard about 24 re-entering settings 232 using 24 status bar about 28 Airplane Mode 29 audio mode 29 battery 28 Block Mode 31 CGM, with 152 CGM, without 26 Connection icon 29 icons 28 insulin amount 29 sensor calibration 30 sensor life 30 time 26 status screens about 31 notifications 31 pump 31 quick status 31 sensor 31 settings review 32 stopping bolus 88 insulin delivery 54 storage mode 242 Stuck button alarm 215 summary screen about 117 basal 118 BG meter readings 119 bolus 118 ■ index summary 120 trend arrows 152 wireless connection 175, 178 Sensor alert occurred responding to 223 Sensor connected message 223 Sensor Demo 146 Sensor expired alert 223 sensor glucose arrows 192 graph 191 high settings 156 history 191 low settings 157 review 122 rise alert 223 sensor alert occurred 223 sensor graph about 191 trend arrows 192 Sensor signal not found alert 224 serial number, pump 12 Set Change reminder 133 settings basal 40 bolus 62 Bolus Wizard 65 CGM 155 low SG 157 product specifications 247 startup 24 troubleshooting 229 SG average 120 SG Std. Dev. 120 SG value not available alert 224 silencing alerts 193 siren 201 sleep mode 35 SmartGuard about 152 icon 155, 159, 162 summary 121 Index 295 MP6025958-022 / A overview 118 total carbs 118 total daily dose 118 viewing 117 supplies, ordering 15 Suspend before low about 158 examples 164, 165, 166 unavailable 159 suspend by sensor icon 155 Suspend on low about 161 examples 166 unavailable 162 suspended delivery, resuming automatically 163 manually 54, 174 suspending insulin delivery 54, 139, 158, 161 unavailable Suspend before low 159 Suspend on low 162 unlocking 26 utilities 33 viewing history, pump settings 145 wireless connection automatic 175 failure 178 manual 178 temp basal rate about 47 percent 47 preset 40 rate 47 starting 48 types 47 Time before high SG setting 156 time, current changing 148 transmitter communication 29 connecting, pump 175, 178 deleting, from pump 181 signal alert 220 Transmitter battery depleted alert 225 trend arrows 192 troubleshooting 229 tubing filling 101 image 19 Max Fill reached alarm 210, 211 296 Index MP6025958-022 / A ■ index Index 297 MP6025958-022 / A 298 Index MP6025958-022 / A MP6025958-022 / A 6025958-022_a MP6025958
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