22 Taking Care of Your Controller and Pod The Omnipod 5 Automated Insulin Delivery System has no user-serviceable parts. If you require assistance operating or maintaining the Omnipod 5 System, call Customer Care. Warning: Store all Omnipod 5 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. 22.1. Pod and Insulin Storage and Care This section describes proper care of your Pod.
Taking Care of Your Controller and Pod 22 Water and your Pod The Pod is waterproof up to a depth of 25 feet (7.6 meters) for up to 60 minutes (IP28). After swimming or similar exposure to water, rinse off the Pod with clean water and gently dry it with a towel. Warning: Do NOT expose your Pod to water at depths greater than 25 feet (7.6 meters) or for longer than 60 minutes. Cleaning your Pod Pods are waterproof.
22 Taking Care of Your Controller and Pod Water and your controller The controller is not waterproof. Do not place it in water or leave it near water where it can accidentally fall in. If it gets wet: 1. Dry the outside of the controller with a clean, lint-free cloth. Caution: Never use a blow dryer or hot air to dry the controller. Extreme heat can damage the electronics. 2. After the controller has thoroughly air-dried, turn ON the controller to see if it is working. 3.
Taking Care of Your Controller and Pod 22 To clean your controller: 1. Press the Power button briefly to put your controller to sleep. 2. Wipe the outer surface of the controller with a damp, lint-free cloth. If necessary, use a solution of a mild detergent mixed in warm water. 3. Dry the outer surface with a dry, lint-free cloth. Caution: While cleaning, do NOT allow debris or liquid to get into the USB port, speaker, earphone jack socket, Sound/vibrate button, or Power button.
22 Taking Care of Your Controller and Pod To safely use the rechargeable battery: • To prolong battery life, store and charge it in a cool, dry place out of direct sunlight. Avoid leaving the battery in a car where temperature extremes can permanently damage the battery. • Your controller may become warm after prolonged use or when exposed to high temperatures. If your controller or battery become hot to the touch, unplug the USB cable if it is plugged in, and avoid touching or holding the controller.
Taking Care of Your Controller and Pod 22 Charging the controller battery Under normal use, the battery should hold its charge for more than one day. An Omnipod 5 app message alerts you when the battery charge is low. The battery icon in the status bar tracks the remaining charge in the battery (see "3.3. Status Bar" on page 24). To charge the battery, see "Charge the battery" on page 46. You can charge your battery many times, but all batteries have a limited lifespan.
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Chapter 23: Understanding Insulin Delivery and Calculations Contents 23.1. Basal Insulin Delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 Manual Mode Basal Programs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 Temporary basal rates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
23Understanding Insulin Delivery and Calculations 23.1. Basal Insulin Delivery Even without eating, our bodies need a small, constant supply of insulin for normal daily living, which is referred to as "basal" insulin. In people without diabetes, the pancreas continuously delivers this basal insulin. For people using the Omnipod 5 System, the Pod can mimic a healthy pancreas by delivering basal insulin continuously as your wear the Pod.
Understanding Insulin Delivery and Calculations23 To create the Basal Program shown in the preceding figure, the following basal segments are programmed into the Omnipod 5 app: Segment Basal rate 1: Midnight–10:00 am 0.20 U/hr Between midnight and 10:00 am, the Pod delivers 0.20 units of insulin per hour. 2: 10:00 am–2:00 pm 0.60 U/hr Between 10:00 am and 2:00 pm, the Pod delivers 0.60 units of insulin per hour. 3: 2:00 pm–midnight 0.30 U/hr Between 2:00 pm and midnight, the Pod delivers 0.
23Understanding Insulin Delivery and Calculations Temp basal settings: Units per hour (U/hr) or percent (%) Temp basals can be set using percent (%) or units per hour (U/hr). Setting temp basals to units per hour (U/hr) means that the Pod delivers insulin at a flat rate for the duration of the temp basal. In other words, the details of the currently scheduled Basal Program are ignored during these temp basals.
Understanding Insulin Delivery and Calculations23 Segment boundaries* Basal rate of 50% increase Basal Program (U/hr) (U/hr) Resulting temp basal rate: (U/hr) Midnight–7:00 am 0.20 7:00 am–10:00 am 0.20 0.20 x 50%=0.10 0.20 + 0.10 = 0.30 10:00 am–2:00 pm 0.60 0.60 x 50%=0.30 0.60 + 0.30 = 0.90 2:00 pm–4:30 pm 0.30 0.30 x 50%=0.15 0.30 + 0.15 = 0.45 4:30 pm–midnight 0.30 * Segments are defined by the currently scheduled Basal Program.
23Understanding Insulin Delivery and Calculations Temp basal presets Some temporary changes in your daily routine are easy to predict, and you may know from experience how they affect your insulin needs. For example, you might join a summer soccer league or attend an exercise class. For women, your monthly hormonal change can affect blood glucose in a predictable manner.
Understanding Insulin Delivery and Calculations23 Beeps at end of specified duration Must be used when Pause insulin Temp basal of 0 U/hr Every 15 min until you tap Start One beep, then insulin starts automatically Editing a Basal Program in progress Changing the time zone Testing alarm and vibrate feature How to cancel the pause Use is never required Home:Temp Basal tab > CANCEL Menu icon ( ) > Start Insulin 23.2.
23Understanding Insulin Delivery and Calculations 23.3. About Manual Boluses A manual bolus is a bolus that you have calculated without the help of the Bolus Calculator. You can use manual boluses when the Bolus Calculator is temporarily disabled or when you choose not to use the Bolus Calculator. Consult your healthcare provider for instructions about how to calculate a bolus. You can extend some or all of a manual bolus in Manual Mode. 23.4.
Understanding Insulin Delivery and Calculations23 When the Bolus Calculator does not work The Bolus Calculator does not work when it is disabled or when there is no Pod communication. Being disabled means that the Bolus Calculator is temporarily unable to calculate a suggested bolus. Your Omnipod 5 app may disable the Bolus Calculator in a few situations. Conditions that disable The Bolus Calculator is the Bolus Calculator: disabled until: Your glucose reading is below your Minimum BG for Calcs setting.
23Understanding Insulin Delivery and Calculations CGM trend The CGM trend is used to suggest up to 30% more correction insulin when your values are rapidly rising, or suggest a subtraction if your values are rapidly falling, compared to just a BG value alone. Target BG When calculating a correction bolus, the Bolus Calculator aims to bring your glucose down to your Target BG.
Understanding Insulin Delivery and Calculations23 Note: In Automated Mode, if using a CGM and trend in the Calculator, the Bolus Calculator may subtract insulin even if your reverse correction setting is OFF, in situations with a decreasing CGM trend. Boundaries of the Bolus Calculator suggestions The following figure shows the boundaries between the types of calculations performed by the Bolus Calculator.
23Understanding Insulin Delivery and Calculations Considerations about Bolus Calculator recommendations Keep the following in mind when using the Bolus Calculator and reviewing its recommendations: • The Bolus Calculator uses your Bolus Calculator settings for the time you are requesting a bolus (See "Bolus Calculator settings" on page 164). • The Bolus Calculator refreshes values every 5 minutes.
Understanding Insulin Delivery and Calculations23 Bolus IOB depletion The graph below shows the IOB from an 8 unit bolus depleting over the set Duration of Insulin Action of 4 hours.
23Understanding Insulin Delivery and Calculations 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.
Understanding Insulin Delivery and Calculations23 Bolus Calculator equations The Bolus Calculator first calculates a preliminary (prelim.) 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. Note: Your adjustments from CGM trend can add or subtract insulin from the correction and/or the meal portion.
Understanding Insulin Delivery and Calculations A Reverse Correction is only applied to the meal bolus. In this example, the meal bolus is reduced by 1.5 units, resulting in a meal bolus of 1.0 U. Bolus Calculator rules The Bolus Calculator applies the following rules to the suggested bolus doses: Rule Rounding Detail Boluses will always be rounded down to the nearest 0.05 U. IOB will always be rounded up to the nearest 0.05 U. Bolus and IOB will never be below 0 U.
Understanding Insulin Delivery and Calculations23 Overview of the Bolus Calculator CALCULATIONS screen You can tap VIEW BOLUS CALCULATIONS from the Insulin & BG history screen or tap CALCULATIONS from the Bolus Calculator screen if you want to view bolus calculation details. Bolus Calculator CALCULATIONS screen (using CGM value) When your CGM value and trend are available, the Bolus Calculator internally calculates your suggested bolus .
23Understanding Insulin Delivery and Calculations 23.5. Bolus Calculator Examples Example 1 Eating 50 g carbs, and 0.6 U meal IOB and 0.5 U correction IOB from previous meal and correction boluses. CGM is not available and BG not entered. Correction Bolus -- U BG = N/A, Target BG = N/A Correction Factor = N/A Meal IOB adjustment Meal IOB = 0.6 U N/A: No BG reading The Bolus Calculator does not adjust your correction bolus by the meal IOB since there is no BG reading.
Understanding Insulin Delivery and Calculations23 Total Bolus = 7U The Total Bolus is the sum of the calculated bolus and any adjustments you made. Example 2 Eating 30 g carbs, no meal or correction IOB. Used CGM value of 180 mg/dL, with rising trend. 1.2 U CGM = 170, Target BG = 130 Correction Factor = 50 (180-130) / 50 = 1 U Meal IOB adjustment Meal IOB = 0 U 1U–0U=1U The Bolus Calculator does not adjust your correction bolus by the meal IOB since there is no meal IOB.
23Understanding Insulin Delivery and Calculations Correction IOB adjustment Remaining correction IOB = 0 U 3U–0U=3U The Bolus Calculator does not adjust your meal bolus by the correction IOB since there is no correction IOB. Adjusted meal bolus = 3.6 U Adjusted for CGM: Rising The meal bolus is increased to account for your rising CGM trend. Calculated Bolus 4.8 U The calculated bolus is the sum of your correction bolus and meal bolus that has been adjusted for rising CGM value. Total Bolus 4.
Understanding Insulin Delivery and Calculations23 Example 3 No carbs entered, used CGM of 180 mg/dL with decreasing trend. There is 0.8 U meal IOB and 0.5 U correction IOB from previous meal and correction boluses. Correction Bolus 0U CGM = 180, Target BG = 130 Correction Factor = 50 (180 -130) / 50 = 1 U Meal IOB adjustment Since you have 0.8 U of meal IOB remaining from a previous meal bolus, this is subtracted from the initial correction bolus of 1 U, and you have 0.2 U of correction bolus remaining.
23Understanding Insulin Delivery and Calculations Calculated Bolus 0U Total Bolus 0U Even though your glucose is above target, you have enough IOB. As a result, the Bolus Calculator recommends that you do not deliver any additional insulin.
Chapter 24: Living with Diabetes Contents 24.1. Infusion Site Checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272 24.2. Being Aware of Your Blood Glucose Levels. . . . . . . . . . . . . . . . . . . . . . . 272 24.3. Traveling and Vacations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 274 Keep supplies accessible. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
24Living with Diabetes 24.1. Infusion Site Checks At least once a day, use the Pod's viewing window to inspect the infusion site. Check the site for: • Leakage or scent of insulin, which may indicate the cannula has dislodged • Signs of infection, such as pain, swelling, redness, discharge, or heat Warning: If an infusion site shows signs of infection: • Immediately remove the Pod and apply a new Pod at a different infusion site. • Contact your healthcare provider.
Living with Diabetes24 usually means your glucose is very low, but your CGM value shows as in your acceptable range, you should confirm by testing with your BG meter. If your BGs are verified too low or too high, consider treatment. A sensor calibration may also be needed; consult your compatible CGM User Guide for more information.
24Living with Diabetes 24.3. Traveling and Vacations It is important that you check your glucose level more frequently while you are traveling. Changes in time zones, activity levels, and meal times can all affect your glucose levels. Proper preparation is important when traveling. The following sections will help you prepare for your travels.
Living with Diabetes24 Plan for changing time zones If you’re planning a vacation or business trip to a different time zone, you may need to adjust Basal Programs that you would typically follow while in Manual Mode. For changes of just a few hours, basal rate adjustments are minor and easy to calculate. For long-distance travel, however, figuring out the correct Basal Program can be more challenging. Your healthcare provider can help with these adjustments.
24Living with Diabetes The Omnipod 5 app sends and receives information from the Pod using Bluetooth® wireless technology. Before flying, check your airline's policy regarding the use of Personal Medical Electronic Devices that communicate using Bluetooth® technology. If use of a Personal Medical Electronic Device using Bluetooth® technology is allowed, set your Omnipod 5 app to airplane mode while on the airplane (see "Airplane mode" on page 153).
Living with Diabetes24 Hypoglycemia (low blood glucose) Hypoglycemia can occur even when a Pod is working properly. Never ignore the signs of low glucose, no matter how mild. If left untreated, severe hypoglycemia can cause seizure or lead to unconsciousness. If you suspect that your glucose level is low, check your glucose level to confirm.
24Living with Diabetes • Keep a glucagon kit with your emergency supplies. Teach friends and family members how to administer a glucagon dosage in case you have severe hypoglycemia and become unconscious. Periodically check the expiration date of your glucagon kit to make sure it has not expired. Note: Always carry medical identification (such as an emergency wallet card) and wear an emergency medical necklace or bracelet such as the Medic Alert tag.
Living with Diabetes24 Possible causes of hypoglycemia Suggested action Adjust insulin delivery as instructed by your healthcare provider. Prolonged or intense exercise Check blood glucose before, during, and after activity and treat as necessary. Note: Effects of exercise can last several hours— even a full day—after activity ends. Consult your healthcare provider about adjusting your Basal Programs or using a temp basal (Manual Mode) or HypoProtect™ (Automated Mode) to avoid hypoglycemia.
24Living with Diabetes Symptoms of hyperglycemia (high glucose) Never ignore the following symptoms, as they could be a sign of hyperglycemia: • Fatigue • Frequent urination, especially during the night • Unusual thirst or hunger • Unexplained weight loss • Blurred vision • Slow healing of cuts or sores To avoid hyperglycemia (high glucose) Check your glucose levels: • At least 4–6 times a day (when you wake up, before each meal, and before going to bed); unless you are using a continuous gluco
Living with Diabetes24 Possible causes of hyperglycemia Empty Pod Incorrect Basal Program (Manual Mode) Suggested action Deactivate and remove the used Pod. Apply a new Pod in a different location. Confirm that the correct Basal Program is active. Consult your healthcare provider about adjusting your Basal Programs or using a temp basal. Check carb intake. Incorrect bolus timing or bolus too small Take bolus with food. Check blood glucose before giving meal bolus. If necessary, adjust bolus.
24Living with Diabetes To treat hyperglycemia (high glucose) Always check your glucose levels frequently while treating hyperglycemia. You don’t want to over-treat the condition and cause your glucose levels to drop too far. 1. Check your glucose levels. The result will help you to find out how much insulin is needed to return your glucose level to your glucose goal. 2. If your glucose is 250 mg/dL or above, check for ketones. If ketones are present, follow your healthcare provider’s guidelines. 3.
Living with Diabetes24 Symptoms of DKA • • • • • • • • Nausea and vomiting Abdominal pain Dehydration Fruity-smelling breath Dry skin or tongue Drowsiness Rapid pulse Labored breathing The symptoms of DKA are much like those of the flu. Before assuming you have the flu, check your glucose level and check for ketones to rule out DKA. To avoid DKA The easiest and most reliable way to avoid DKA is by checking your glucose levels at least 4–6 times a day.
24Living with Diabetes flu, check your glucose level to rule out DKA (see "To treat hyperglycemia (high glucose)" on page 282). To handle sick days: • Treat the underlying illness to promote faster recovery. • Eat as normally as you can. Your body still needs carbohydrates and insulin for energy. • Adjust bolus doses, if necessary, to match changes in meals and snacks. • Always continue your basal insulin, even if you are unable to eat.
Living with Diabetes24 X-rays, MRIs, and CT scans The Pod and controller can tolerate common electromagnetic and electrostatic fields, including airport security and cellular phones. Warning: The Pod and controller may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove and dispose of your Pod and place your controller outside the treatment area. Check with your healthcare provider on Pod removal guidelines.
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Appendix Summary of Settings and Options The options for the various Omnipod 5 Automated Insulin Delivery System settings are: Time format 12-hour Time zone GMT-11:00 to GMT+13.00. Daylight Savings Time ON or OFF. Default based on date and time zone. Date format MM/DD/YYYY Screen time-out 30, 60, 120 seconds. Default is 30 seconds. PIN 4 digits from 0 to 9. CGM G6 transmitter 6 characters. serial number Maximum Basal Rate 0.05-30 U/hr. Default is 3.00 U/hr. Basal rate Units/hr.
Appendix Correct Above threshold Maximum of 8 segments; Target BG to 200 mg/dL in 1 mg/dL increments. Minimum BG for Calcs 50 to 70 mg/dL in 1 mg/dL increments Default is 70 mg/dL. Insulin-to-carb (IC) Maximum of 8 segments; 1 to 150 g carb/U in ratio 0.1 g carb/U increments. Correction (sensitivity) Maximum of 8 segments; 1 to 400 mg/dL in 1 mg/dL factor increments. Default is 50 mg/dL. Reverse Correction ON or OFF. Default is ON. Duration of insulin 2 to 6 hours in 30-minute increments.
Appendix Waterproof rating: IP28 (25 feet (7.6 meters) for up to 60 minutes) Insulin concentration: U-100 Alarm type: Audible.
Appendix Controller Specifications Size: 5.67” high x 2.66” wide x 0.49” deep (143.92 mm x 67.57 mm x 12.33 mm) Weight: 5.82 oz (165 grams) Screen active area: 2.21" wide x 4.75" high (56.16 mm x 120.58 mm) Communication distance: The controller and Pod should be • At startup: Adjacent and touching, either in or out of tray, to ensure proper communication during priming. • During normal operation: Within 5 feet (1.5 m) of each other.
Appendix Protection from Over-infusion or Under-infusion The Pod software monitors the infusion rate. If an error that would result in overor under-infusion is detected and cannot be corrected, insulin delivery stops, and an alarm sounds. Blockage detection A blockage is an interruption in insulin delivery from the Pod. If the Omnipod 5 System detects a blockage, it sounds a hazard alarm and prompts you to deactivate and change your Pod.
Appendix Performance Characteristics The Omnipod 5 insulin pump delivers insulin in two ways: basal insulin delivery (continuous) and bolus insulin delivery. The following accuracy data was collected on both types of delivery in laboratory studies performed by Insulet. Delivery performance characterization Basal Delivery: To assess basal delivery accuracy, 12 Pods were tested by delivering at low, medium, and high basal rates (0.05, 1.00, and 30.0 U/hr). Water was used as a substitute for insulin.
Appendix Bolus Delivery: To assess bolus delivery accuracy, 12 Pods were tested by delivering a minimum, intermediate, and maximum bolus amount (0.05, 5.00, and 30.0 Units). Water was used as a substitute for insulin. The water was pumped into a container on a scale and the weight of the liquid delivered was used to assess pumping accuracy. The following table summarizes the typical bolus performance observed for the requested minimum, intermediate, and maximum size bolus for all pumps tested.
Appendix The tables below show for each requested bolus size the range of amount of insulin that was observed delivered compared to the requested amount. Each table provides the number and percent of delivered bolus sizes observed within the specified range. Amount of Insulin Delivery for a Minimum (0.05 U) Bolus Request Amount (Units) <0.0125 0.01250.0375 (% of settings) (<25%) (25-75%) (75-90%) (90-95%) (95-105%) Number and percent of boluses within range 61/5987 (1%) 639/5987 (10.
Appendix Amount of Insulin Delivery for an Intermediate (5.00 U) Bolus Request Amount (Units) <125 1.25-3.75 3.75-4.50 4.50-4.75 4.75-5.25 (% of settings) (<25%) (25-75%) (75-90%) (90-95%) (95-105%) Number and percent of boluses within range 0/300 (0%) 0/300 (0%) 1/300 (0.3%) 4/300 (1.3%) 287/300 (95.7%) 5.25-5.50 5.50-6.25 6.25-8.75 8.75-12.50 >12.50 (% of settings) (105-110%) (110-125%) (125-175%) (175-250%) (>250%) Number and percent of boluses within range 8/300 (2.
Appendix CGM-Informed Bolus Calculator Clinical Study A study was conducted in 25 participants with type 1 diabetes aged 6-70 years to assess the Omnipod 5 CGM-informed Bolus Calculator. During Phase 1, participants used the Omnipod 5 system in Manual Mode for the first 7 days without a connected CGM (standard Bolus Calculator). In Phase 2, participants used the Omnipod 5 system in Manual Mode with a connected CGM (CGMinformed Bolus Calculator) for 7 days.
Appendix Omnipod 5 System Label Symbols The following symbols appear on the Omnipod 5 System or its packaging: Symbol Meaning Single use only Consult accompanying documents Sterilized using ethylene oxide Date of manufacture Batch code Use by date Reference number Serial number Symbol Meaning MR unsafe Do not use if package is damaged Type BF applied part Manufacturer Keep dry Storage temperature, Operational temperature Storage relative humidity, Operational relative humidity Storage atmospheric press
Appendix Omnipod 5 System Notice Concerning Interference The Omnipod 5 Automated Insulin Delivery System is designed to comply with Part 15 of the Federal Communications Commission (FCC) Rules. Operation is subject to the following two conditions: 1. These devices may not cause harmful interference. 2. These devices must accept any interference received, including interference that may cause undesirable operation.
Appendix electrical equipment; older equipment may be particularly susceptible to interference. General Notes Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this document and the instructions for use. If the Omnipod 5 System fails due to electromagnetic disturbances, you may need to replace it.
Appendix CISPR B Emissions Classification Electromagnetic Emissions Class B The System is suitable for use in all establishments including domestic establishments. Electromagnetic Immunity The System is intended for use in the electromagnetic environment specified below. You should observe these requirements in the use of the System.
Appendix Customer's Bill of Rights Mission Statement Insulet Corporation is dedicated to designing, developing, and distributing products that provide superior treatment options and lifelong health benefits for people with diabetes. Scope of Services Insulet Corporation’s scope of services is limited to providing the Omnipod 5 Automated Insulin Delivery System.
Appendix Customer's Bill of Rights and Responsibilities You have the right to: 1. Receive considerate and respectful service. 2. Receive service without regard to race, creed, national origin, sex, age, disability, sexual orientation, illness, or religious affiliation. 3. Expect confidentiality of all information pertaining to you, your medical care and service. Please review our HIPAA Privacy Notice later in this section. 4. Receive a timely response to your request for service. 5.
Appendix Limited Express Warranty, Disclaimer, and Limitation of Remedies for the Controller and Pods LIMITED EXPRESS WARRANTY, DISCLAIMER OF IMPLIED WARRANTIES AND LIMITATION OF REMEDIES FOR THE Omnipod 5 AUTOMATED INSULIN DELIVERY SYSTEM HANDHELD CONTROLLER AND PODS (United States of America) LIMITED EXPRESS WARRANTY COVERAGE Limited Warranty Coverage for the Omnipod 5 Automated Insulin Delivery System Handheld Controller Subject to the terms and conditions stated herein (“Limited Express Warranty”), Ins
Appendix not limited to, a repair kit or replacement part(s) Insulet provides) or refers you to a third party, you must obtain a prior authorization and return the Controller or the Pod to Insulet. The Controller or Pod must be properly packaged and returned to Insulet according to the instructions provided in the Return Merchandise Authorization, or RMA, Kit.
Appendix INCIDENTAL, OR CONSEQUENTIAL DAMAGES CAUSED BY A DEFECT IN THE CONTROLLER OR A POD OR BY A BREACH OF THE ABOVE LIMITED EXPRESS WARRANTY, WHETHER SUCH CLAIM IS BASED IN WARRANTY, CONTRACT, TORT OR OTHERWISE.
Appendix HIPAA Privacy Notice THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
Appendix Family, Friends and Emergencies: If you require emergency treatment and we are unable to obtain your consent, we may disclose your Medical Information to a family member or relative who is involved in your care. Marketing: We may use or disclose your Medical Information to provide you with marketing communications about the health-related products and services that we provide, and about products, services, treatment or healthcare providers that may be of interest to you.
Appendix Criminal Activity: Consistent with applicable federal and state laws, we may disclose your Medical Information, if we believe the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. We may also disclose Medical Information if it is necessary for law enforcement authorities to identify or apprehend an individual.
Appendix You Have the Right to Request a Restriction of Your Medical Information: You may ask us not to use or disclose any part of your Medical Information for the purposes of treatment, payment or healthcare operations. You may also request that any part of your Medical Information not be disclosed to family members or friends who may be involved in your care or for notification purposes as described in this HIPAA Privacy Notice.
Appendix Our Duties Generally: We are required by law to maintain the privacy and security of your Medical Information and to provide you with notice of our legal duties and privacy practices with respect to Medical Information, and to notify you if there is a breach resulting in disclosure of your unsecured Medical Information. Revisions and Modifications: We may change this HIPAA Privacy Notice at any time.
Index A About screen 36 Action Item Notifications Compatibility App Not Compatible 206 Attention - Use at Own Risk 207 Not Compatible 208 OS Not Compatible 210 Phone Settings Connect to a Wireless Network 207 Device Not Secure 209 Not Enough Storage 209 Stop Optimizing Battery Usage 211 Turn Bluetooth ON 211 Turn Notifications On 213 Time Changes Daylight Savings Time Change 208 Turn On Automatic Date and Time 212 Updates Update Omnipod 5 - App No Longer Supported 214 Update Omnipod 5 - Software Update 214
Index flow accuracy 289 maximum, setting 162 basal segment 250 battery, App stop optimization 211 battery, controller charge 46 preserve 153 battery, PDM charge 247 blockage detection 291 Hazard Alarm 195 blood glucose HIGH and LOW results 114, 131 Target BG 164, 257–270 Bluetooth controller 153 turn on 211 Bolus Calculator bolusing with 90 disabled 96, 257 Food Library 101 sample calculations 263 settings 164–166 using CGM 93 bolus, extended based on blood glucose 90 based on carbs 90–91 cancel 99 deliver
Index create new basal program 78 temp basal preset 85 CT scans 285 Customer Care, contact i custom food, create 106 custom reminder notification 221 setting 160 D damaged PDM 245 Dashboard tab 27 data entry, how to 18 date Automatic date and time on. See also Action Item Notifications: Time Changes: Turn On Automatic Date and Time daylight savings time 208 default settings 287 device not compatible.
Index System Error 199 HIPAA privacy notice 306 history records and time change 179 blood glucose 172–180 carbs 172–180 insulin, basal and bolus 172–180 hospitalization 285 hyperglycemia 279–281 avoiding 280 symptoms 280 treating 282 hypoglycemia 276–280 avoiding 277 symptoms 277 treating 279 Hypo Protect activate 147 cancel 147 I IC Ratio 165, 257 illness 283 indications for use 6 infusion site guidelines for selection 65 preparation 68 insulin cleared for use 8 history records 172–180 rapid-acting vs.
Index application 206 device 208 OS (operating system) 210 not enough storage 209 Notifications Action Item Notification.
Index electrical 298–310 screen brightness 154 protector 17 sensitivity 17 time-out 153 Searching for CGM 132 security application 49 controller 48 set temp basal activating 83 settings airplane mode 153 Bolus Calculator 164–166 check BG after bolus 158 confidence reminders 160 Correct Above 164 Correction Factor 166 custom reminders 160 Duration of Insulin Action 166 extended bolus configuration 163 IC Ratio 165 lock screen image 154 lock screen message 154 low reservoir 157 Maximum Basal Rate 162 Maximum
Index insulin 61, 242 PDM storage 243 Pod 61, 288 text, entering 18 time-out, controller screen 153 Time Zone device time zone (controller) 155 touchscreen 17 brightness 154 sensitivity 17 time-out 153 Transmitter Error 132 Transmitter Not Found 132 travel 275–276 U U-100 insulin 8 unconfirmed bolus 177 unlock controller 25 Urgent Low Glucose advisory alert 205 USB cable 244 V vacation 275 vibration or sound notifications 192 W wake up controller 25 warranty 303 water and the PDM 244 and the Pod 243 webs
My Settings Chapter 20: Notes Use these pages to keep track of your important settings. Remember to update your information if you change or add settings.
My Settings Insulin-to-Carbohydrate Ratio (IC Ratio) Correction Factor Correction Factor for each time segment midnight 1 unit of insulin IC Ratio for each time decreases BG by segment 1 unit of insulin covers to mg/dL midnight to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb to mg/dL to g carb Duration of Insulin Action Time that insulin remains “active” in the body after a bolus hrs Temp Basal P
My Notes Effective Date: 22DEC2020, PCO-000267
® Omnipod 5 Automated Insulin Delivery System User Guide Insulet Corporation 100 Nagog Park Acton, MA 01720 1-800-591-3455 | 1-978-600-7850 omnipod.com Pod shown without the necessary adhesive. FCC ID: #TBD Controller # TBD FCC ID: #TBD Pod © 2020 Insulet Corporation. Omnipod and the Omnipod logo are trademarks or registered trademarks of Insulet Corporation in the United States of America and other various jurisdictions. All rights reserved.
