Adjusting Settings 9 Diagnostics Check alarms To verify that your PDM and Pod's alarms and vibration functions are working properly, you can test them as follows: 1. Navigate to: Settings icon ( ) > PDM Device > Check Alarms. 2. If you have an active Pod, tap SUSPEND INSULIN and tap YES. 3. Tap CHECK ALARMS to initiate the alarm check. 4. Listen and feel: The PDM beeps and vibrates three times. Then, if you are wearing a Pod, the Pod beeps several times and sounds the alarm tone for several seconds. 5.
9 Adjusting Settings To reset your PDM: 1. Prepare a list of your personalized settings so you can re-enter them after you reset your PDM. Consult with your healthcare provider to ensure that the settings are appropriate for you. Tip: Record your current settings on the pages at the end of this User Guide. 2. Navigate to: Settings icon ( ) > PDM Device > Reset PDM. 3. If you have an active Pod, tap DEACTIVATE POD, then tap DEACTIVATE POD again. 4. Tap RESET PDM, and then tap RESET PDM again.
Adjusting Settings 9 Before you begin Before you begin downloading and installing a software update, make sure the following requirements are met: • No active Pod. If you have an active Pod, deactivate it. • Wi-Fi is ON. If your Wi-Fi is OFF, turn it ON and connect to a Wi-Fi network. (See "Wi-Fi" on page 100.) • PDM battery charge is at least 30%. If below 30%, plug in the PDM until the charge is above 30%. After you confirm meeting these requirements, proceed to the following steps.
9 Adjusting Settings 6. Read the message about battery power and PDM use during the software installation, and plug in your PDM if the charge is below 30%. Once above 30%, tap OK. Warning: The software update process will take a few minutes. Please refrain from excessive operations during the update and make sure your device is plugged into a power source or has more than a 30% charge before starting the installation process. 7. Wait for several minutes while the software update is installed.
Adjusting Settings 9 Reminder Settings Reminders and notifications bring items related to PDM and Pod function to your attention (see "Notifications List" on page 129 and "Informational Signals List" on page 131). Pod expiration The Pod expiration notification tells you when the Pod is nearing its expiration so you can plan to change your Pod at a convenient time. You can set this notification to appear from 1 to 24 hours before the Pod expiration advisory alarm.
9 Adjusting Settings 3. If Auto-off is enabled, tap the Inactivity Timer field and select the length of time for the countdown timer. This setting can range from 1 to 24 hours. Example: If you choose 10 hours, you must wake up your PDM and unlock it at least once every 10 hours, day and night, to prevent the Auto-off alarm. 4. Tap SAVE. Warning: You must use the PDM within 15 minutes of the onset of the Auto-off advisory alarm.
Adjusting Settings 9 Enable or disable a single missed bolus reminder To turn an individual missed bolus reminder on or off: 1. Navigate to: Settings icon ( ) > Reminders > Missed Bolus. 2. Tap the toggle next to an individual missed bolus reminder to turn it on or off. Add a new missed bolus reminder To add a new missed bolus reminder: 1. Navigate to: Settings icon ( ) > Reminders > Missed Bolus. 2. Tap Add Reminder. The Add Reminder button does not appear if missed bolus reminders are disabled. 3.
9 Adjusting Settings Confidence reminders When confidence reminders are on, you will hear a tone at the start and end of a bolus, extended bolus, or temp basal: • The PDM beeps at the start. • The Pod beeps at the end. Confidence reminders are especially useful when you are getting familiar with your PDM and Pod. To turn confidence reminders on or off: 1. Navigate to: Settings icon ( ) > Reminders. 2. Tap the Confidence Reminders toggle to turn confidence reminders on or off.
Adjusting Settings 9 Edit or turn on or off an individual custom reminder If custom reminders are enabled, you can edit or turn on or turn off an individual custom reminder: 1. Navigate to: Settings icon ( ) > Reminders > Custom Reminders. 2. Tap the name of a custom reminder. 3. Tap the toggle next to Custom Reminder to turn this custom reminder on or off. 4. Make any desired changes to the frequency, day(s), time, name, and text. 5. Tap SAVE. Add a new custom reminder To add a new custom reminder: 1.
9 Adjusting Settings Blood Glucose Settings The Blood Glucose settings allow you to change the BG Goal Range and to pair or unpair BG meters. BG Goal Range The goal of using the Omnipod DASH™ System is to keep your blood glucose within a certain range. This is called your BG Goal Range. You define this range by setting the upper and lower limits of your BG Goal Range.
Adjusting Settings 9 The PDM scans for available CONTOUR® NEXT ONE BG meters, and then displays a list of paired and available BG meters. 4. Turn your BG meter over to find its seven digit serial number. Verify that this number matches the one on the PDM screen. 5. To pair to a new BG meter: a. Tap PAIR below your BG meter's serial number. Note: A CONTOUR® NEXT ONE BG meter can only be paired to one PDM at a time.
9 Adjusting Settings Basal and Temp Basal Settings The following sections describe how to change settings that control basal insulin delivery: the Maximum Basal Rate and temp basal settings. Maximum Basal Rate The Maximum Basal Rate defines an upper limit for any basal rate used in your Basal Programs and temp basals. Consult your healthcare provider before changing this setting. To change your Maximum Basal Rate: 1. Navigate to: Settings icon ( ) > Basal & Temp Basal > Max Basal Rate. 2.
Adjusting Settings 9 Bolus Delivery Settings These settings allow you to change your Maximum Bolus, extended bolus, and Bolus Calculator settings. Maximum Bolus The Maximum Bolus defines the upper limit for a bolus. The Bolus Calculator informs you if it calculates a bolus that is over this amount. The largest allowed value of the Maximum Bolus is 30 units. Caution: Check with your healthcare provider before adjusting this setting. To change your Maximum Bolus: 1.
9 Adjusting Settings Turn the Bolus Calculator on or off To turn the Bolus Calculator on or off: 1. Navigate to: Settings icon ( ) > Bolus. 2. Tap the toggle on the Bolus Calculator row to turn it on or off. 3. If this is the first time you have turned the Bolus Calculator on, follow the screen's instructions or see "Target BG and Correct Above values" on page 33. The following sections tell you how to edit these settings.
Adjusting Settings 9 Insulin to Carb Ratio (IC Ratio) The insulin to carbohydrate ratio (IC Ratio) defines how many grams of carbohydrates are covered by one unit of insulin. The Bolus Calculator uses your IC Ratio to calculate a meal bolus when you are going to eat. To edit this value: 1. Write a list of all of the desired IC Ratio segments to guide you through reentering the values for each segment. Tip: You can write this list on the pages at the end of this User Guide. 2.
9 Adjusting Settings Reverse Correction The Reverse Correction setting determines how the Bolus Calculator handles meal boluses when your blood glucose value is below your Target BG (see "Reverse Correction" on page 158 for more details). To turn Reverse Correction on or off: 1. Navigate to: Settings icon ( ) > Bolus. 2. Tap the toggle on the Reverse Correction line to turn it on or off.
CHAPTER 10 Alarms, Notifications, and Communication Errors Overview Warnings: Respond to hazard alarms as soon as possible. Pod hazard alarms indicate that insulin delivery has stopped. Failure to respond to a hazard alarm can result in hyperglycemia. If you need to return the PDM for replacement, contact your healthcare provider for instructions about using injections to ensure appropriate insulin delivery.
10 Alarms, Notifications, Communication Errors Responding to Alarms To respond to a hazard alarm or advisory alarm: 1. Wake up your PDM. The Lock screen shows an alarm message along with the hazard alarm ( ) icon or advisory alarm ( ) icon. 2. Unlock your PDM. After you enter your PIN, a full-screen alarm message appears. Note: If you are using your PDM when an alarm occurs, the alarm message appears as a full-screen message. 3.
Alarms, Notifications, Communication Errors 10 If you are using your PDM when a notification is triggered, the notification message appears at the top of the screen. To remove the message from the screen: • Do nothing. The message disappears after several seconds and is saved as a new message. • Swipe up to remove the message immediately and save it as a new message. • Swipe right to remove the message immediately and save it as an acknowledged message.
10 Alarms, Notifications, Communication Errors You can prevent these hazard alarms by responding to their advisory alarm in a timely manner. Note: As an extra alert, a Pod Expiration ( Expired advisory alarm. ) notification precedes the Pod Sounds and Vibrations The Omnipod DASH™ System uses sounds and vibrations to attract your attention to an alarm or notification. Tip: To test the sounds and vibrations, see "Check alarms" on page 105.
Alarms, Notifications, Communication Errors 10 The Sound/vibrate button The PDM's Sound/vibrate button, located on the upper right edge of the PDM, controls whether the following reminders use vibrations or audible tones: Check BG after Pod change, Check BG after bolus, Missed bolus, No Pod, and Custom reminders. • To turn vibrations on, press and hold the lower end of the Sound/vibrate button until the vibrate icon ( ) appears on the indicator.
10 Alarms, Notifications, Communication Errors Auto-Off—The Pod has stopped delivering insulin because you did not respond to the Auto-off advisory alarm. Both the Pod and PDM sound the alarm. To change the Auto-off setting, see "Pod Auto-off" on page 109. For more information about how Auto-off works, see "Auto-off" on page 148. Message: Auto-Off. Insulin delivery stopped. Your PDM and Pod have not communicated in the last . To resume insulin delivery, change your Pod.
Alarms, Notifications, Communication Errors 10 PDM Error—An unexpected error is detected in the PDM. The PDM sounds the alarm. Message: PDM Error. Remove Pod now. Call Customer Care. Ref: . What to do: Tap OK to silence the alarm. Remove your Pod. Call Customer Care immediately. Check your blood glucose. PDM Error Message: PDM Error. Tap "OK" to reset clock. What to do: Tap OK. Reset the clock. Change your Pod. Check your blood glucose.
10 Alarms, Notifications, Communication Errors Advisory Alarm List Advisory alarms inform you of a situation that needs your attention in the near future. Warnings: Three advisory alarms (Pod Expired, Low Reservoir, and Auto-off) become hazard alarms and result in a stoppage of insulin delivery if ignored. Be sure to respond to all advisory alarms when they occur. The individual advisory alarms are summarized here. Pod Expired—Your Pod will stop delivering insulin soon.
Alarms, Notifications, Communication Errors 10 Resume Insulin—The time period that you specified for insulin suspension has passed. If you do not resume insulin delivery, you could develop hyperglycemia. Both the Pod and PDM sound the alarm. Vibration/tone: Once a minute for 3 minutes. Repeats every 15 minutes until insulin delivery is resumed. Message on Lock screen: Resume Insulin. The insulin suspension period has ended.
10 Alarms, Notifications, Communication Errors The notifications are: Pod Expiration—Tells you how much time is left before the Pod expiration advisory alarm. To change the timing of this notification, see "Pod expiration" on page 109. Both the Pod and PDM sound the notification. Vibration/tone: A set of three beeps. Repeats periodically until acknowledged. Message: Pod Expiration. Pod expires at
Alarms, Notifications, Communication Errors 10 Custom Reminder—The PDM shows a message of your choice. To create or edit these reminders, see "Custom reminders" on page 112. Vibration/tone: Every 15 min until acknowledged. Message: . What to do: Acknowledge the message (see "Acknowledging notifications" on page 123). Wireless Update (Software Update)—This message reminds you that a software update has been wirelessly downloaded but not yet installed. Message: Wireless Update.
10 Alarms, Notifications, Communication Errors Pod activation—These tones or vibrations occur at various times during the Pod activation process to indicate progress. You cannot turn these off. Pod beeps: Twice when it has been filled with the minimum amount of insulin needed for activation (see page 41). PDM tones/vibrations: When the Pod and PDM are successfully paired.
Alarms, Notifications, Communication Errors 10 Warnings: If you are unable to deactivate a Pod, it continues to pump insulin. Be sure to remove the old Pod before activating a new Pod. Giving too much insulin can cause hypoglycemia. If your PDM is damaged or not working as expected, call Customer Care for assistance. Be sure to check your blood glucose frequently. Remove your Pod and contact your healthcare provider for treatment guidelines.
10 Alarms, Notifications, Communication Errors If the PDM has sent the Pod the instruction and hasn't received confirmation that it was carried out, the PDM offers these options: • CHECK STATUS: Move to a new location, then select this option to recheck for confirmation that the instruction was carried out. • DEACTIVATE POD: Select this option and follow the PDM's instructions for replacing your Pod.
Alarms, Notifications, Communication Errors 10 temporarily disabled." You can deliver a manually-calculated bolus when the Bolus Calculator is disabled. Silencing an Alarm You can usually silence Pod or PDM alarms by tapping a button on the alarm screen. If the alarm continues, or if you are discarding a Pod and want to prevent a future alarm, follow the directions in this section. Pod alarm To permanently silence a Pod alarm: 1. If the Pod is on your body, remove it. 2.
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CHAPTER 11 Taking Care of Your PDM and Pod The Omnipod DASH™ Insulin Management System has no user-serviceable parts. If you require assistance operating or maintaining the Omnipod DASH™ System, call Customer Care. Warnings: Store all Omnipod DASH™ System products and supplies, including unopened Pods, in a cool, dry place. Products or supplies that have been exposed to extreme temperatures may not function properly. Pod and Insulin Care This section describes proper care of your Pod.
11 Taking Care of Your PDM and Pod Warning: Do NOT expose a Pod to direct sunlight for long periods of time. Remove your Pod prior to using hot tubs, whirlpools, or saunas. These conditions could expose the Pod to extreme temperatures and may also affect the insulin inside the Pod. If you remove your Pod to avoid exposing it to extreme temperatures, remember to check your blood glucose levels frequently. Check with your healthcare provider for guidelines if you will not use a Pod for extended periods.
Taking Care of Your PDM and Pod 11 PDM storage When you are not using your PDM, store it in a convenient, nearby location that is cool and dry. If the PDM is not safe from children or others who may press the buttons by accident, do not share your PDM's PIN number with anyone. Also, store the PDM in a safe place. Long term storage of the PDM If you are not going to use your PDM for an extended period of time, allow your battery to reach approximately 50% charge.
11 Taking Care of Your PDM and Pod 4. Leave the battery compartment door open until the PDM is thoroughly dry. 5. After the PDM has thoroughly air-dried, replace the battery and replace the door to the battery compartment. 6. Turn on the PDM to see if it is working. 7. If the PDM is not working, call Customer Care. Caution: The PDM is not waterproof. Do NOT place it in or near water.
Taking Care of Your PDM and Pod 11 Every time you clean your PDM, examine the entire PDM for discoloration, cracks, or separations. Also check for deteriorating performance, such as illegible messages, button malfunction, or repeated communication failures. If you notice any signs of deterioration, stop using the PDM. Call Customer Care if you have questions or for information about PDM replacement. If you drop the PDM Shock or a severe impact can damage your PDM.
11 Taking Care of Your PDM and Pod • Do not connect the battery poles with pieces of metal, such as keys or jewelry. Doing so may short-circuit the battery and cause injuries or burns. • Do not expose the battery or its charger to liquids, including water, rain, or snow, as this can cause malfunction. If the battery or charger is exposed to liquid, allow it to dry. • Do not allow anyone, including children and pets, to put the battery in their mouth. Doing so may result in damage or explosion.
Taking Care of Your PDM and Pod 11 Note: If the PDM battery is critically low and the PDM has turned off, your Pod continues to deliver basal insulin according to the active Basal Program or temp basal. If you do not charge your PDM battery, this insulin delivery continues until the Pod expires. Note: The history records stay in memory for 60 days even if the battery power is critically low or the battery is removed.
11 Taking Care of Your PDM and Pod 4. If a battery is in place, put your fingernail in the slot just below the battery on the right-hand side and lift out the battery. 5. Orient the new battery so the three gold tabs on the battery line up with the three gold pins in the battery compartment. The "-" and "+" signs on the battery label should face you. Caution: Do not remove the label from the battery. Caution: Be careful not to damage any of the small metal parts inside the battery compartment. 6.
CHAPTER 12 Understanding PDM and Pod Function This chapter explains how the PDM and Pod interact, features such as basal and bolus insulin delivery, and how the Bolus Calculator works. PDM and Pod Interactions This section describes how the PDM controls the Pod, and what the Pod can do without input from the PDM.
12 Understanding PDM and Pod Function When you are not actively using the PDM, store it in a nearby location, such as a shirt pocket or in a drawer, briefcase, or purse. Status checks: How the PDM checks Pod function The PDM periodically queries the Pod about its status, called a "status check." The PDM performs a status check: • When you wake up the PDM. • When you navigate to the Pod Info tab. • Periodically, whether the PDM is awake or asleep.
Understanding PDM and Pod Function 12 When the PDM cannot communicate with the Pod When the PDM attempts to communicate with an active Pod that is in range, communication usually occurs quickly. The PDM cannot communicate with the Pod when: • The PDM is, or has temporarily been, too far from the Pod; for example, when you attend a meeting, leaving your PDM back at your desk. • The PDM's battery has run down.
12 Understanding PDM and Pod Function What the Pod can do between PDM instructions Once activated, the Pod can perform the following without input from the PDM: • Deliver insulin according to the active Basal Program's schedule. The Pod has a built-in clock that allows it to track the timing of the Basal Program's segments. • Stop delivery of a temp basal at the scheduled time and resume delivery of the active Basal Program.
Understanding PDM and Pod Function 12 PDM and Paired BG Meter Interaction The following actions occur whenever you sync your PDM with a paired BG meter: • The PDM transmits its time, date and goal/target range information to the BG meter, overwriting the BG meter’s time, date and goal/target range if they differ. This ensures that the time of blood glucose readings and boluses can be compared accurately.
12 Understanding PDM and Pod Function Approximately 50% of a person’s total daily insulin dose typically comes from basal insulin delivery; the remaining 50% typically comes from bolus doses. This section describes the Omnipod DASH™ System's two modes for delivering continuous basal insulin: Basal Programs and temp basals. Basal Programs A basal rate is the number of units of insulin delivered per hour. A basal segment defines the time of day during which a given basal rate is delivered.
Understanding PDM and Pod Function 12 You may have different routines on different days of the week; for example your weekend routine may differ from your weekday routine. To handle these predictable changes in your routine, you can create up to 12 different Basal Programs (see "Basal Programs" on page 81). This figure shows two possible Basal Programs, one for weekdays and the other for weekends. Basal Rate (U/hr) 1.0 Weekday Basal Program Weekend Basal Program 0.8 0.6 0.4 0.
12 Understanding PDM and Pod Function Temp basal set to U/hr set to 0.9 U/hr 1.0 Basal Rate (U/hr) 0.8 set to 0.1 U/hr 0.6 0.4 0.2 0 12 AM 12 AM 12 AM Noon Noon 12 AM Temp basal set to % 50% increase 1.0 Basal Rate (U/hr) 0.8 50% decrease 0.6 0.4 0.
Understanding PDM and Pod Function 12 Temp basal limitations Prohibited temp basals: You cannot set a temp basal of 0%, as there would be no change from the active Basal Program. Maximum temp basal: • When using percent (%), you can set the temp basal up to 95% more than your active Basal Program's rate with the following exception: You cannot set a temp basal that would go above your Maximum Basal Rate during any time segment covered by the temp basal duration.
12 Understanding PDM and Pod Function Methods to temporarily stop insulin delivery There may be times when you want to stop all insulin delivery, or at least all basal insulin delivery, for a period of time. If you do not want to deactivate your current Pod, you can request a temporary halt of insulin delivery as follows: • Suspend insulin delivery: Menu icon ( • ) > Suspend Insulin. Set a temp basal to turn off insulin delivery: Menu icon ( ) > Set Temp Basal. Then select 100% decrease or 0 U/hr.
Understanding PDM and Pod Function 12 Immediate and Extended Boluses A bolus is an extra dose of insulin that is delivered in addition to the continuous basal rate of insulin delivery. Use boluses to bring down high blood glucose levels and to cover the carbohydrates (carbs) in a meal. You have the option of delivering the entire bolus at once. This is referred to as an "immediate bolus" or, simply, a "bolus.
12 Understanding PDM and Pod Function The Bolus Calculator The PDM's Bolus Calculator can do a lot of the work of calculating a bolus for you. The Bolus Calculator uses your personal settings and also takes into account any insulin that remains from recent boluses (referred to as insulin on board or IOB).
Understanding PDM and Pod Function 12 When the Bolus Calculator does not work The Bolus Calculator does not work when it is disabled or when it is set to off. You control whether the Bolus Calculator is turned on or off, but the PDM controls when it is disabled. If the Bolus Calculator is set to off, the PDM does not track IOB and does not suggest a bolus. If the Bolus Calculator is set to on, the PDM may disable it in a few situations.
12 Understanding PDM and Pod Function Target BG When calculating a correction bolus, the Bolus Calculator aims to bring your blood glucose down to the Target BG. Correct Above threshold The Bolus Calculator only suggests a correction bolus if your blood glucose reading is above your Correct Above setting. This feature can prevent corrections to blood glucose values that are only slightly higher than your Target BG.
Understanding PDM and Pod Function 12 Boundaries of the Bolus Calculator suggestions The following figure shows the boundaries between the types of calculations performed by the Bolus Calculator. For example, the Bolus Calculator suggests a meal bolus, but not a correction bolus, if your blood glucose reading is between your Target BG and your Correct Above settings.
12 Understanding PDM and Pod Function Insulin on board (IOB) After a bolus is delivered, the amount of insulin that is active in the body decreases over several hours. The Bolus Calculator approximates this decrease in insulin by calculating an ‘insulin on board’ (IOB) value. The calculated IOB value decreases over time and reaches zero at the time set by the Duration of Insulin Action value.
Understanding PDM and Pod Function 12 Insulin on board (IOB) calculations Duration of insulin action – time since previous bolus x previous bolus Duration of insulin action IOB from a previous correction bolus is called a “correction IOB.” IOB from a previous meal bolus is called a “meal IOB.
12 Understanding PDM and Pod Function Bolus Calculator equations The Bolus Calculator first calculates a preliminary correction and meal bolus. It then adjusts these preliminary values for IOB, if applicable. The final suggested bolus is equal to the sum of the resulting correction bolus and meal bolus. Preliminary correction bolus = Current BG - Target BG Correction Factor Example: Current BG: 200 mg/dL, Target BG: 100 mg/dL Correction Factor (CF): 50 200 mg/dL – 100 mg/dL = 2 U prelim.
Understanding PDM and Pod Function 12 Bolus Calculator rules The Bolus Calculator applies the following rules to the suggested bolus doses: • Suggested bolus doses are rounded down to the nearest 0.05 U. • If the total of the suggested bolus calculation (correction bolus plus meal bolus) is less than zero, the suggested bolus dose is 0.00 U. • The Bolus Calculator does not suggest a bolus dose if your current blood glucose reading is below your Minimum BG for Calcs.
12 Understanding PDM and Pod Function Overview of the Bolus Calculator CALCULATIONS screen The Bolus Calculator's screen can be accessed by tapping VIEW BOLUS CALCULATIONS from the Insulin & BG history screen or by tapping CALCULATIONS from the Bolus Calculator screen. Your current blood glucose reading and Target BG setting are listed here. Your Correction Factor setting is listed here. A correction bolus is adjusted for meal IOB first ... ... then for correction IOB.
Understanding PDM and Pod Function 12 The preliminary and final boluses in the CALCULATIONS screen The Bolus Calculation screen shows the calculations for a preliminary bolus first (correction and meal bolus), and then shows the IOB adjustments that produce the final correction bolus and final meal bolus. See "Bolus Calculator equations" on page 162 for a step-by-step description of these calculations.