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1. 0 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 Time min l Appendices Flow rate error The following trumpet curve shows the accuracy of the delivery rate in relation to the observation period The measurements were made using a Pod with a basal rate of 1 0 U h at high oper ating temperature The overall mean percentage flow error was 1 94 100 Error of Flow O 100 200 300 400 500 600 700 800 900 1000 1100 1200 1300 1400 1500 Observation Interval min 145 Appendices Personal Diabetes Manager Specifications Size 2 5 wide x 4 5 long x 1 0 high 6 4cm x 11 4cm x 2 5cm Weight with batteries 125 grams 4 4 oz Screen 1 4 wide x 1 9 long 3 6cm x 4 8cm 2 4 diagonal 6 1cm LCD Battery Powered by 2 AAA alkaline batteries Battery life Approximately 3 weeks Operating temperature range 40 F to 104 F 5 C to 40 C Storage temperature range 14 F to 122 F 10 C to 50 C Operating relative humidity range 5 to 90 noncondensing Storage relative humidity range 5 to 90 noncondensing Operating atmospheric pressure 700 hPA to 1060 hPA Storage atmospheric pressure 700 hPA to 1060 hPA Communication distance Up to 24 61cm Alarm type Audible Warranty 4 years Blood Glucose Meter Specifications Assay method Coulometric electrochemical sensor Calibration Plasma equivalent
2. Bo 00 ant BO zoop 2m Are you going to eat Suggested bolus 1 00u now BG 150 mg dL Insulin on board 0 00 u 1 00uU Cancel No Yes Back Enter To view detailed information about the calcula TPLA tions used for this suggested bolus press the User Info Support button and scroll through the infor mation screens Press Close to return to the Suggested Bolus screen 32 Understanding and Delivering Bolus Doses 4 3 If you are going to eat now a Press Yes Figure 4 2 on previous page enter the number of carbohydrates you are about to eat then press Enter If you ve previously entered a carb preset then either e Use the Up Down Controller buttons to choose enter manually then press Select Enter the num ber of carbohydrates that you are going to eat then press Enter Use the Up Down Controller buttons to choose favorites snacks or meals From there select a carb preset you have previously entered see Carb Presets later in this chapter then press Select u The OmniPod System includes a reference food library For more information see Reference Food Library at the end of this chapter b Press Enter to accept the suggested bolus Figure 4 4 ak 3 00p 2 11 Suggested bolus 5 00 u Carbs 60g BG 150 mg dL Insulin on board 0 00 u Back Extend Enter 5 00u Or press the User Info Support button to view calculation in
3. ccc cece ccc ec cece ceeeceeneeeenes 39 Change or edit a carb preset ccc cc cece ce eeeceeeeees 40 Delete a carb preset inada 41 Reference Food Library cee ce cee cececeeeeeeenes 42 Access the reference food library eeeeeeceeeeees 42 USING the POG 55 65 5406 nie ieeddaesied siutaweseeewsasess 43 The Pod Change Process cccecececeeeeeeeeeeenes 43 Gather equipment and supplies cece eee eeeeeee 44 Deactivate the current Pod sssssnssssenessesssssssss 44 Fla RCW POCA caissoisdvrelatalcnmiaigcutidoaneneahianerass 46 Select TNE IMIUSIONSILG see onc tad a E 49 Prepare the infusion Site cece cece eee cece ce eeeeees 50 Apply the new Pod cccccceeeecceeeeeeeeeceeneeees 51 Insert cannula and begin insulin delivery 66 52 Check Pod StatuS ccc cece e cece eee EEEa 54 Suspend Insulin Delivery c cece cece cece ee eeees 55 Resume Insulin Delivery ccceceeeeeeeeeeeneees 56 Avoid Infusion Site Infections cece cence eee eeees 56 Get the Most From Your Pod cece cence ence eeees 57 Avoid extreme temperatures ccc cece cece eee eeceeees 57 Water and your Pod sis ssersrscrer isens e E 57 Sale StOVAGE eae e a a a 57 Using the Personal Diabetes Manager 58 The Status ScreCNS verserer an iara REET 58 Insulin gauge and display ccc cece ee
4. b Press the middle soft key labeled with the right arrow to note Asa Safety feature the words Invalid basal program move the underscore to the next character a name Figure 3 4 appear if the name you entered c Enter each character one at a time For example if your does not have at least one character or if the name is weekend schedule is different from your weekday sched being used for another basal program Capitals and ule you might enter W e e k e n d Figure 3 3 A blank lowercase letters are considered the same Press OK character or space is the first and last option in the scroll to return to the previous screen and enter a different ing menu paG 5 Enter the rate in U hr for the first basal segment from 0 05 to p z000 2 11 A EINA the maximum you entered during setup then press Next Edit name Invalid basal program 6 Review the list showing your new basal program Weekenii name To use the same basal rate for the entire 24 hour program press Done and continue with step 7 m Enter a unique name Or to add basal segments and rates for example a higher basal rate between 8 00 am and 3 00 pm a Choose an existing basal segment then press Edit Or choose add new then press New b Enter the start time for example 8 00 am then press Se eee eee Next Basal segments are in 30 minute increments Back Next OK c Enterthe end time for example 3 00 pm the
5. USB Port grea OmniPod N t O 3 00p 2 11 a ee a i More actions i amp Temp basal LCD Screen D My records Soft Key d Labels Soft Keys Home User Info Power i Support Up Down Test Strip Port Controller Your New OmniPod Insulin Management System 1 Buttons that program and control the OmniPod System Home Power Gn Up Down Controller 9 Soft Keys Select Save Back Pressing and holding turns the PDM on and off When the PDM is on pressing this button displays the Home screen from which you can choose a menu item or view the Status screens shown later in this chapter Pressing scrolls through a list of available menu options or numbers so you can pick the one you want Holding the button scrolls faster Soft key labels and functions depend on the menu or screen you are viewing The label appears on the screen directly above the phys ical button you press Select Save and Back are just three examples of the soft key labels on your PDM User Info Support Pressing opens a User Info Support screen that displays additional information about the current screen you are viewing The User Info Support icon appears when additional infor mation can be viewed It may be displayed at the top of the screen to the right of an event detail such as a suggested bolus or to the right of a record item such as a BG history record See Personal
6. 5 Investigate possible cause for hypoglycemia to avoid similar problems in the future see Possible causes of hypoglycemia low blood glucose on the next page How much is 15 grams of carbohydrate Examples of fast acting foods Three 5 gram glucose tablets or four 4 gram tablets 4 ounces 118 milliliters of apple or orange juice 6 Lifesavers or similar hard candy 1 2 can of regular non diet soda 2 tablespoons 30 milliliters of table sugar honey or corn syrup Teach people you trust like family members and close friends how to give a glucagon injection You will need to rely on them to give it to you if you have severe hypoglycemia and become unconscious Include a copy of the glucagon instructions in your emergency kit and periodically review the proce dure with family and friends 112 Possible causes of hypoglycemia low blood glucose Incorrect basal program Incorrect bolus timing Bolus too large Confirm that correct basal program is active Confirm that PDM time is set cor rectly Consult your healthcare provider about adjusting your basal pro grams or using a temporary temp basal rate Take bolus with food Check blood glucose before giving meal bolus if necessary adjust bolus Check bolus size and timing Do NOT overcorrect for post meal glucose levels Check carb intake Consult healthcare provider for guidance Living with Diabetes 9 Incorrect tar
7. If the PDM is not safe from children or others who may press the buttons by accident consider using the optional PDM lock safety feature to prevent accidental program changes see Chapter 6 Using the Personal Diabetes Managers 136 Appendices Cleaning You can clean the outside of the PDM with a clean damp cloth CAITR Do NOT use IV Prep wipes alcohol wipes soap W detergent or solvents Never put any liquid into the battery compartment If the battery compartment becomes soiled gently shake out the debris or use a dry lint free cloth to remove it Replacing batteries The PDM uses two 2 AAA alkaline batteries You can purchase them at any grocery hardware or convenience store Do not use any other type of batteries than AAA alkaline batteries to power the PDM Never use old or used batteries the PDM may not work properly Using any kind of batteries other than alkaline may reduce battery life and cause damage to the PDM On average a pair of batteries powers the PDM for 3 weeks The battery life indicator on the PDM shows the battery power level See Personal Diabetes Manager Icons on page 147 for the vari ous battery power levels and their respective icons The PDM automatically alerts you when its battery power gets low see Figure A 1 When you see the Low PDM battery alert press OK to turn off the alert Replace the batteries as soon as you can A 3 00p 2 11 Low PDM batter
8. Some settings have preset defaults but all settings are changeable See the Appendices for a list of Sys tem specifications including preset default settings u For additional details on bolus and basal settings see Chapter 3 Understanding and Adjusting Basal Rates and Chapter 4 Understanding and Deliver ing Bolus Doses 65 6 Using the Personal Diabetes Manager Alerts and Reminders In addition to automatic safety alarms see Chapter 10 Errors Advisories and Hazard Alarms the OmniPod System offers a number of alerts and reminders that you can set to help you manage your diabetes These features are optional You can turn alerts and reminders on or off at any time Alerts and reminders you can use are BG blood glucose reminder Reminds you to check your blood glucose Choose from On or Off The default setting is Off When the reminder is on the PDM asks you each time you enter a bolus dose whether you want to set a BG reminder and you can then choose a time interval in 1 2 hour increments Expiration Alerts you when the Pod is nearing the 72 hour expi ration time Choose an alert period from 1 to 24 hours before expiration in 1 hour increments The default setting is 4 hours Low reservoir Alerts you when insulin in the Pod reaches a cer tain level so you can plan ahead to change the Pod Choose a level from 10 to 50 units in 5 unit increments The default setting is 10 units Auto off
9. Home screen Midnight program or selected history record BG tag gt Submenu Temperature out of range OmniPod System Federal Communications Commission FCC Notice Concerning Interference The OmniPod Insulin Management System both the Pod and the Personal Diabetes Manager or PDM complies with Part 15 of the 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 includ ing interference that may cause undesirable operation Changes or modifications not expressly approved by Insulet could void the user s authority to operate the equipment Both the Pod and the PDM generate use and can radiate radio frequency energy and may cause harmful interference to radio communications There are no guarantees that interference will not occur in a particular installation Ifthe OmniPod System does cause harmful interference to radio and television reception the interference may be corrected by one of the following measures Move or relocate the OmniPod System e Increase the distance between the OmniPod System and the other device that is emitting or receiving interference 148 Appendices Electromagnetic Compatibility The information contained in this section such as separation distances is in general specifically written with regard to the OmniPod System The numbers provided will not guara
10. See Chapter 5 Using the Pod for details on activating a Pod Your New OmniPod Insulin Management System 1 Home screen Lists all the major menus Figure 1 4 on previous page Bolus menu to deliver bolus doses e More actions menu to change the Pod manually enter blood glucose readings and assign and edit tags for BG read ings that are less than 2 hours old Temp basal menu to deliver temporary basal rates This submenu does not appear if Temp basal is turned Off in Settings My records menu to review insulin delivery blood glucose history alarm history carb history and personal user informa tion e Settings menu to edit enter and name basal programs temp basal carbohydrate and bolus presets and to custom ize System settings e Food library menu to display a reference library of over 1 000 common food items BG history menu to open the Blood Glucose History screen e Suspend menu to suspend cancel or resume insulin delivery programs note YOU can go to the Status screen at any time by i pressing Status from the Home screen Safety Features The OmniPod System s state of the art design includes the latest safety technology Its built in safety features include Automatic priming safety checks and insertion Every time you activate a new Pod the System automatically primes and performs a safety check on the Pod then inserts and primes the cannula see Chapter 5 Using the Pod Micro
11. Time date and total amount of last bolus delivered Name and rate of active basal program or temp basal program Ext bolus the amount of insulin and the delivery time remaining if an extended bolus is being delivered m 50 U 3 00p 2 11 Last BG 150 mg dL 1 00p today Last bolus 1 00u 1 00p today basal 1 0 70 Uhr Pod exp 9 37a 2 14 Home INSULIN SUSPENDED if insulin delivery has been suspended Time and date when the Pod will expire 58 Using the Personal Diabetes Manager 6 the screen displays No active Pod Would you like to acti vate a Pod now See Chapter 5 Using the Pod for details on activating a Pod If a Pod has not yet been activated as during Pod changes Insulin gauge and display One of the important icons on the Status screen is the insulin gauge at the top of the screen It indicates how much insulin is left in the Pod s reservoir As the reservoir empties the icon changes to indicate the amount of insulin remaining Next to the insulin gauge the PDM displays the number of units remaining in the Pod As long as more than 50 units remain the gauge displays 50 U Once the reservoir volume drops to 50 units the gauge counts down unit by unit When the volume falls below 5 units the display changes to LOW u Regularly checking the insulin gauge enables you to plan Pod changes easily For example if you know you will need app
12. processor technology makes it possible to complete thousands of safety checks in only a few seconds The OmniPod System also performs safety checks on the PDM If it detects any problems in the PDM or the Pod or in commu nication between them it informs you with beeps and on screen messages Rapid occlusion detection An occlusion is a blockage or interruption in insulin delivery If the OmniPod System detects an occlusion it sounds a hazard alarm and prompts you to deactivate and change your Pod see Chapter 10 Errors Advisories and Hazard Alarms 1 Your New OmniPod Insulin Management System Alerts and alarms For your safety the OmniPod System provides a range of alerts and alarms to tell you that your attention is needed or to warn you of hazardous situations See Chapter 6 Using the Personal Diabetes Manager for a description of alerts and reminders and how to set them See Chapter 10 Errors Advisories and Hazard Alarms for a list of safety alarms built into the OmniPod System and how to respond to them Getting Started The OmniPod Starter Kit Your Starter Kit contains everything you need to begin using the OmniPod System note Please refer to the Starter Kit for a complete list of package contents If you are a first time OmniPod System user you need to meet with your healthcare provider for training and System setup before using it To get a head start on learning about your new OmniPod S
13. 9 04a today Last bolus 1 15u 8 44 today t 3 00p 2 11 t3 3 00p 2 11 Press Confirm to Pod deactivated ee oo i begin the pod change E yon a ane process Remove and discard the ONG ean en pod and then press This will deactivate your Next current pod Your temp basal will be P b Use soap and water to remove any adhesive that remains cancelled on the skin or if necessary use an adhesive remover Back Confirm Next Check the infusion site for signs of infection See Avoid Infusion Site Infections later in this 5 After you press Confirm you will see the message in chapter Figure 5 4 To remove the old Pod a Gently lift the edges of the adhesive tape from your skin c Discard the used Pod according to local waste disposal and remove the entire Pod Figure 5 5 regulations l 6 After removing the old Pod press Next Figure 5 4 u Removing the Pod slowly will help to avoid l possible skin irritation 7 Press Yes to fill a new Pod Figure 5 6 45 5 Using the Pod Filla new Pod 3 Pull outward to remove the protective cap from the needle Figure 5 8 Save the cap you will need it later Before filling a Pod with insulin ensure that the Pod is above 50 Fahrenheit 10 Celsius If the Pod has Use care aier removing the needle cap and been exposed to temperatures below 50 F 10 C Tos then allow the Pod to be brought back to room tem perature
14. Automated cannula insertion With the OmniPod System you don t have to insert the infusion set manually or carry around a separate inserter You simply press a button on the PDM and the Pod s automated insertion system safely and consistently inserts the cannula beneath the skin vir tually pain free It then begins delivering insulin according to your programmed basal rate A fully integrated design with blood glucose monitoring With a fully integrated two part design there s no need to carry separate infusion sets reservoirs or inserters It s all integrated into the Pod With the PDM you can check your blood glucose level using FreeStyle blood glucose test strips but without the hassle of carrying a separate blood glucose meter If you prefer to use another blood glucose meter you can enter the readings manually into the PDM 1 Data on file at Insulet Corporation Your New OmniPod Insulin Management System 1 Suggested bolus calculation Calculating bolus doses has never been easier After you check your blood glucose enter the carbs for your snack or meal Based on your individual settings the System displays a suggested bolus dose You can accept the suggestion change it or cancel it Reference food library and carb presets To make carbohydrate counting easier the OmniPod System includes a reference food library You can look up the carbs and other values for many standard food items Foods are organized
15. If a Pod is active and fails to to choose Settings then press Select beep change the Pod immediately see Chapter 5 2 Choose System setup then press Select Using the Pod Continuing to use the System in these situations may put your health and safety at risk To check alarms 1 Choose Check alarms then press Select Reset PDM soft reset Restores all settings in the PDM to the 2 Press OK The PDM beeps three times If a Pod is active the factory defaults Pod then beeps three times Resetting the PDM deletes all basal programs temp S Z__ Check the alarm function at every Pod change basal presets carb presets bolus presets and all sug ule gested bolus settings Before you use this feature and delete these settings be sure you have a written To reset the PDM record of the information you need History records will not be deleted 3 Choose Diagnostics then press Select 1 Choose Reset PDM then press Select 2 Ifthe Pod is deactivated the PDM asks for confirmation and reminds you that you will lose all user settings Figure 6 14 on note As a safety feature you cannot reset the PDM when a the following page Press Confirm to reset the PDM Pod is active You must first deactivate the Pod be ante aes If the Pod is still active you will be unable to reset the PDM Figure 6 15 on the following page Press OK to return to the Diagnostics menu 73 6 Using the Personal Diabetes Manager
16. feel resistance when you depress the plunger These conditions can result in underdelivery of insulin 10 Remove the needle from the insulin fill port The port is self sealing insulin will not leak after the needle is removed Z Avoid using insulin from more than one vial which ei in reduce aintac ie nae COTS TT Do not insert the fill syringe into the fill port more V than once 8 Remove the needle from the vial and insert it straight down into the insulin fill port on the underside of the Pod AN Figure 5 10 ganung NEVER inject air into the fill port Doing so may result in unintended or interrupted insulin delivery 4 5 Using the Pod 11 Place the protective cap back on the needle and remove the needle from the syringe 12 Place the capped needle in a sharps container Dispose of used needles according to local waste disposal regulations U The fill syringe is intended for single use only and W should be used only with the OmniPod System 13 After you fill the Pod it will beep twice After you hear the beeps press Next Figure 5 11 The Pod will only beep if you have filled it with at least 85 units of insulin If you have filled the Pod with more than 85 units and still do not hear the 2 beeps call Customer Care 800 591 3455 from outside the United States 781 457 5098 14 The System performs a series of safety checks and automati cally primes the Pod
17. lost If this occurs the PDM will not new ones at hand The longer the batteries are display insulin totals for any day containing lost removed the more the memory is at risk records Y The record for this item is unconfirmed nore When you power on the PDM it will request a status update from the active Pod and then update the this task It automatically stores records of insulin delivery his tory blood glucose readings alarms and carbohydrates Special symbols in record screens In the record screens you may encounter several special symbols insulin history If the PDM does not receive a status update from the Pod the PDM will update history Records with a question mark symbol next to them have with unconfirmed records The next time the PDM additional information available To see this information use receives a status update it will update these records the Up Down Controller buttons to highlight the record oe a then press the User Info Support button to view details C This insulin delivery item spans midnight The date given about that record is the start date 97 8 Understanding Your Records Insulin Delivery Records The PDM stores e Basal rates including any rate changes and temporary basals Bolus doses both normal and extended e Dates times and how long insulin delivery was suspended and dates and times when it was resumed e Total daily doses basal plus boluses
18. you will see the screen in Failure During Bolus Cancellation ij Figure 11 11 instead When you instruct the PDM to cancel a bolus if the PDM cannot send your instruction to the Pod within a few seconds it displays the Communication error screen Figure 11 12 A 3 00p 2 11 Pod status not available Pod has passed expiration time Change pod now A 300p 2 11 A 3 00p 2 11 Communication error Communication error Bolus status unknown Move to a new area and Last status 2 11 2 35p C then press Retry or A press Discard to deactivate pod Move PDM close to pod Status Home At either Pod status not available screen press Home to return to the Home screen or press Status to send another status I request Discard Retry Move the PDM close to the Pod The PDM tries to communi cate with the Pod again If the PDM still cannot communicate with the Pod you will see the Bolus status unknown message Figure 11 13 133 11 Communication Failures 3 Move across the room or to a different room Then either a Press Discard to begin the deactivation process b Press Retry to repeat the attempts to communicate with the Pod The PDM tries to communicate with the Pod again If it cannot communicate it displays the same screen as in Figure 11 13 then finally a second Bolus status unknown screen Figure 11 14 Press OK to chec
19. 2 43p 1 00 Uhr 11 36a 1 40u 2 43p Pod activated Back Event Basal For a temporary basal the display shows the adjustment to the default basal So in Figure 8 3 1 10 temp U hr 10 means that you delivered a temporary basal of 1 10 units per hour which was 10 more than the default basal Notice that two hours later the basal rate returns to the default Also the Pod activated entry shows what time you applied a new Pod Press the Up Down Controller buttons for earlier or later dates Understanding Your Records 8 Press Event to use the Up Down Controller buttons to scroll through the list of information on the screen Choose a record then press the User Info Support button to view details about that record Record details may include insulin delivery that was interrupted due to a Pod alarm Pod deacti vation or user cancellation The screen shows the amount of the bolus or basal that remained undelivered 4 Press Day to return to dates To review your bolus history by day press Bolus The display indicates whether the bolus was normal or extended marked e Figure 8 4 Normal and extended boluses are displayed separately even if they were pro grammed at the same time Extended boluses are shown with time and duration If an extended bolus is active a dia mond icon appears next to it If a bolus was cancelled only the amount delivered before cancellation is shown unit increm
20. 7 19 This number must match the code on the side of the vial 3 00p 2 11 S 300p 2 11 Enter code Apply a blood sample to the strip 4 gt 27 Calibration code 27 Light Light To change the code number press the Up Down Controller buttons until the number matches the number on your vial The numbers are between 1 and 50 If you do not adjust the code number within 2 seconds the next screen appears automatically Figure 7 20 86 Checking Your Blood Glucose 7 note Ifyou need to adjust the code number after the PDM 5 Gently squeeze your finger if needed until a blood drop the has moved to the next screen just press the Up Down size of a pinhead forms Controller buttons The code screen reappears and you can adjust the number The code number remains on the PDM screen for your reference until you have completed the BG test The code number on the screen should match the code number on the side of your test strip vial Fig ure 7 5 They must always match or your results will be inaccurate 0 Lance your finger 1 To stimulate blood flow keep your hand warm or lower your hand to waist level and gently massage your finger 2 Set the depth setting on the lancing device to its shallowest depth 1 Figure 7 21 3 Lightly touch the lancing device with the gray cap against the side of your fingertip Figure 7 22 4 Depress the rel
21. Adjusting Basal Rates Choose the segment to change then press Edit Figure 3 9 E 3 00p 2 11 amp 3 00p 2 11 Weekend Press Save to update Segment U hr Weekend add new my 12 00a 8 00a 0 60 8 00a 3 00p 0 80 3 00p 12 00a 0 70 0 50 ooo lt 12a 6a 12p 6p 12a Back Edit Cancel Save List Or choose add new then press New Enter a start time for the segment you want to change then press Next 4 Enter an end time for this segment then press Next Ov U Enter a basal rate for the new segment then press Enter To save the newly entered segment into the basal program press Save Figure 3 10 If you want to make additional edits repeat steps 2 5 To see the program as alist press List To see the graph again press Graph To rename a basal program 1 After choosing a program from the list choose Rename then press Select Press the Up Down Controller buttons to enter the charac ters that spell out the new name you want Press the middle soft key labeled with the right arrow to move the under score to the next character then press Save To copy a basal program 1 After choosing a program from the list choose Copy then press Select Press the Up Down Controller buttons to enter the charac ters that spell out the name you want for the copied file Press the middle soft key labeled with the right arrow to move the
22. Figure 5 12 Once complete the PDM beeps letting you know that the priming and safety checks were successful 3 00p 2 11 e 3 00p 2 11 Filla new pod with insulin After filling pod listen for 2 beeps then press Z Next Priming Cancel Next note After filling the Pod with insulin you should complete the Pod change process within 60 minutes As a reminder that the Pod has been filled it will beep every 5 minutes to indicate that time is passing If you do not set up the Pod within 60 minutes you must deactivate and discard it PDM it can only receive commands from that PDM Once a Pod is activated and communicates with the not from any other 48 Select the infusion site Before applying a new Pod you must first select an appropriate infusion site Due to ease of access and viewing the abdomen is often used Your healthcare provider may suggest other poten tial sites that like the abdomen typically have a layer of fatty tissue such as the hip back of upper arm upper thigh or lower back Figure 5 13 and Figure 5 14 on the following page Avoid sites where belts waistbands or tight clothing may rub against disturb or dislodge the Pod Also avoid sites where the Pod will be affected by folds of skin q Change the site each time you apply a new Pod A q new infusion site should be at least 1 away from the last site Using the same location repeated
23. Next to set up your Personal Diabetes Manager PDM Next Set date and time 1 Use the Up Down Controller buttons to increase or decrease the time If you prefer a 24 hour clock press 12 24hr Then press Next Enter the current year then press Next Choose the current month then press Next Enter the current day then press Next Si ee OTS Choose the date format you prefer then press Next 2 Getting Started Enter basal settings 1 Choose a maximum basal rate then press Next The default maximum basal rate is 3 U hr Choose the initial basal rate to use then press Next The initial basal program created with the Setup Wizard is named basal 1 You can change the name in the Settings gt Basal programs menu see Chapter 3 Understanding and Adjusting Basal Rates Press Done to confirm the basal program shown on the screen To add more basal segments to the program or to change the rate shown see Chapter 3 Understanding and Adjusting Basal Rates To see the basal program as a list press List To return to the graphic view press Graph Press Save to accept the basal program you have set Choose a temporary basal feature then press Next Choose to show temporary basal rates as a percent increase or decrease of your current basal rate Choose U hr to show temporary basal rates in units per hour Or choose Off to turn off the temporary basal feature For details a
24. Started 2 Tosave the ratio press Done To change the ratio select the segment you wish to change and press Edit You can define up to 4 insulin to carbohydrate time seg ments To enter additional ratios choose add new then a Press New b Enter a start time for the segment then press Next c Enter an end time for the segment then press Next d Enter the insulin to carb ratio for the new time segment then press Next e To save the new ratio press Done 3 Tosee the ratios as a list press List To return to the graphic view press Graph 4 Press Save to accept the ratios you have set Enter correction factor 1 Use the Up Down Controller buttons to enter how much one unit of insulin decreases your blood glucose then press Next 2 To save the correction factor press Done To change the factor select the segment you wish to change and press Edit You can define correction factors for up to 4 time segments To enter additional correction factors choose add new then a Press New Enter a start time for the segment then press Next Enter an end time for the segment then press Next oo g0 Enter the correction factor then press Next e To save the new correction factor segment press Done 3 Tosee the factors as a list press List To return to the graphic view press Graph 4 Press Save to accept the correction factors you have set Set reverse correction 1 To set reverse correc
25. Suggested bolus dose 1 correction 3 meal 0 IOB 4U Example 3 Current BG level 100 mg dL Carb intake 45 carbs Insulin on board 1 unit Correction bolus 100 mg dL current 100 mg dL target 0 0 50 CF 0 units Meal bolus 45 carbs 15 I C ratio 3 units Suggested bolus dose 0 correction 3 meal 1 IOB 2U Example 4 Current BG level 150 mg dL Carb intake 45 carbs Insulin on board 1 unit Correction bolus 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 45 carbs 15 I C ratio 3 units Suggested bolus dose 1 correction 3 meal 1 IOB 3U 141 Appendices Calculator guidelines e Areverse correction only occurs if the meal bolus is greater When the suggested bolus calculator is turned On the OmniPod than 0 00U System applies these guidelines to the suggested bolus doses If your blood glucose value is below the target blood glucose Suggested bolus doses are rounded down to the nearest value and you have set reverse correction to On the sug 0 05U gested correction bolus is subtracted from the suggested e Ifthe total of the suggested bolus calculation correction les eee ee AAE E a oe bolus plus meal bolus is less than zero the suggested bolus y gg bolus dose dose is 0 00U If you manually increase or decrease the suggested bolus the e The System will not suggest a bolus dose if your current following rale are
26. The Communication Process cece cece eee eee ees 129 Failure During Pod Activation or Operation 129 Failure During Pod Deactivation ceceeeeeees 131 Failure During Request for Status 0cec eee eens 132 Failure During Bolus Cancellation cce cece ees 133 Failure During a Hazard Alarm cceceeeeeeeees 135 ADDENGICES Hecacccdetsaccwcicdedissedee dateciaatavences 136 Pod Care and Maintenance cece eee ee eeeeees 136 SOMA Ce re a E iets gcteltas ER 136 CENING c arsercter tacnitiea A E 136 Personal Diabetes Manager Care and Maintenance 136 SOLAS saree vances eda taendine eat ers ehusaas eeaemune ees 136 GIGGING eeraa dubs se a a a tenses eileen 137 Replacing batteries cece cece cece eee eeeneeeeenees 137 If the PDM becomes submerged in water 0065 138 If you drop the PDM ccceeeeeeeeceeeeeeeeeeeeees 139 Storage and SUPPMIES vis0csswsdasvereaetnaeaawesieeeaes 139 SOGE Mele tiatis aiaadetsdia a aT me tcneminas tatamemsaeanes 139 Ordering SUPpIieS ccc cece ccc ce eee e cent eeeeneeees 139 Suggested Bolus Calculator Examples 0045 140 Meal bolus calculation c cece cceeeeceeeeceeeeees 140 Insulin on board calculation ccc ec ceeeeeeeeeees 140 Examples of suggested bolus calculations 6 141 Calculator guidelines ccccccceeeceeeneeeeeeeee
27. To ensure accurate results wash your hands and the f 7 test site for example your forearm with soap and A M water Do not leave any cream or lotion on the test Sa site Thoroughly dry your hands and the test site aN Clear cap for testing sites other than the finger Gray cap for finger testing 83 7 Checking Your Blood Glucose Prepare the lancing device 4 Replace the cap until it snaps or clicks into place Figure 7 14 1 Snap off the cap on the lancing device at an angle Be careful not to touch the exposed needle on the lancet Figure 7 11 2 Insert anew FreeStyle lancet firmly into the white lancet holder cup Figure 7 12 Pushing the device into the cup may cock the device which is fine wore Use the clear cap to lance at the following test sites forearm upper arm hand thigh and calf Use the gray cap for finger tests only 3 Hold the lancet firmly in place with one hand With your other hand twist off the rounded top Figure 7 13 84 Checking Your Blood Glucose 7 5 Thelancing device offers four different depth settings Level 1 6 Pull out the dark gray cocking handle until it clicks Figure 7 is the shallowest depth level 4 is the deepest Move the dial 16 You may have already cocked the handle in step 2 This is to the desired setting as shown in the depth indicator win okay dow Figure 7 15
28. after resetting the PDM As a safety feature you can change date and time settings only when the Pod is deactivated or when insulin delivery is sus pended see Chapter 5 Using the Pod 1 Suspend insulin delivery time without suspending by changing the date or lf you are changing the Pod you can reset the date or time before activating the new Pod 2 Onthe Home screen use the Up Down Controller buttons to choose Settings then press Select 3 Choose System setup then press Select 4 Choose Date time then press Select 5 Choose either Time or Date then press Edit Reset the time 1 To enter the current time press the Up Down Controller buttons Press and hold the button to increase or decrease the time faster 60 Using the Personal Diabetes Manager 6 2 Press 12 24 hr to choose either a 12 hour or 24 hour clock 4 Choose the date format to be displayed by the PDM then then press Enter Figure 6 3 press Select 5 Press Confirm to accept the new date and format If you suspended insulin delivery to change the aT 3 00p 2 11 aT 3 00p 2 11 me Confirm time or date remember to resume insulin deliv Enter current time a Irm to ery If you changed the time or date during the Pod change process remember to activate a new Pod New time 1 36p 1 36 gt Change Bolus and Basal Settings You and your healthcare provider entered initial bolus and basal System settings using the
29. avoid potential problems by knowing the signs of hypoglycemia low blood glucose hyperg lycemia high blood glucose and diabetic ketoacidosis DKA The easiest and most reliable way to avoid these conditions is to check your blood glucose often General precautions e Keep careful records and discuss changes and adjustments with your healthcare provider Tell your healthcare provider if you have extreme highs or lows or if highs or lows are occurring more often than usual e Ifyou have technical problems with your OmniPod System and cannot resolve them do not hesitate to call our 24 hour Customer Care line at 800 591 3455 from outside the United States 781 457 5098 Hypoglycemia low blood glucose Hypoglycemia can occur even when a Pod is working properly Never ignore the signs of low blood glucose no matter how mild If left untreated severe hypoglycemia can cause seizures or lead to unconsciousness If you suspect that your blood glu cose level is low check your BG level to confirm Hypoglycemia unawareness is a condition in which you do not realize when your blood glucose level is low If you are prone to hypoglycemia unawareness you may want to use the OmniPod System s blood glucose reminder and check your blood glucose more frequently See Alerts and Reminders in Chap ter 6 Using the Personal Diabetes Manager for how to set the reminder i Symptoms of hypoglycemia Never ignore these symptoms
30. before filling it with insulin CENTON Only use room temperature insulin when filling 1 Use an alcohol prep swab to clean the top of the insulin vial the Pod then discard the prep swab 2 Securely twist the fill needle onto the syringe Figure 5 7 4 Determine the amount of insulin you need to insert into the Pod For example if you will use this Pod for 48 hours you need enough insulin to last you 48 hours Your healthcare provider will help you determine the correct amount begin operation The Pod can deliver up to 200 units of insulin 5 Draw air into the syringe up to the amount of insulin you want 6 Insert the needle into the insulin vial and inject the air This makes it easier to withdraw insulin from the vial The Pod requires a minimum of 85 units of insulin to 46 Using the Pod 5 7 Turn the vial and syringe upside down Withdraw insulin from S Z__ Toensure proper fill do not insert fill syringe at an the vial into the syringe expelling any air bubbles Fill at least ee angle into the fill port to the MIN minimum fill line Figure 5 9 Do not use any other type of needle or filling device besides the syringe provided with each Pod 9 Depress the syringe plunger to completely empty the insulin into the Pod The Pod will beep indicating that the System is ready to proceed to the next step NEVER use a Pod if you hear a crackling noise or
31. by date The PDM can store over 5 000 records or approximately 90 days worth of information Once the memory is full new information begins to replace the oldest information View insulin delivery records 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select 2 Choose Insulin delivery then press Select Figure 8 1 The PDM displays a summary of today s information including total boluses delivered total basal amount deliv ered and total daily dose delivered Figure 8 2 Press the Up Down Controller buttons to view the summary for previous days Wherever you see the symbol press the User Info Support button to see additional information i 1 00p 2 11 i 1 00p 2 11 Insulin delivery Insulin totals today IBGhistory sis Bolus 52 23 90u Alarm history Basal 48 22 30u Carb history Total daily 46 20u All history My info Back __ Select Back Bolus Basal 3 To review your basal history by day press Basal The display shows the basal deliveries that have occurred for the current day most recent first Figure 8 3 on the next page The active basal rate or program is indicated by a dia mond icon 4 98 Back Event Bolus A 11 00p 2 11 r 11 00p 2 11 Basal history today Bolus history today 5 00p 1 00 U hr 2 37p 2 90u 2 00 e 3 00p temp me ioe u A 37p 1 25u LISU pYA LOM 11 36a 2 65u 1 00e
32. closely mimics the insulin release ofa healthy pancreas Since the landmark 10 year Diabetes Control and Complications Trial DCCT the long term health benefits of maintaining near normal blood glucose levels have been widely recognized 1 Your New OmniPod Insulin Management System How Does the OmniPod System Work The Pod is a small lightweight self adhesive device that you fill with insulin and wear directly on your body The Pod delivers precise personalized doses of insulin into your body through a small flexible tube called a cannula based on instructions that you program into its wireless companion the Personal Diabetes Manager The cannula is inserted only once with each Pod The Personal Diabetes Manager PDM is a wireless handheld device that Programs the Pod with your personalized insulin delivery instructions Wirelessly monitors the Pod s operation e Incorporates a FreeStyle blood glucose meter With just two parts you ll enjoy all the functionality and benefits of continuous insulin delivery and blood glucose monitoring Plus you ll enjoy the safety convenience and freedom of No tubing There is no tubing connecting the Pod to the PDM You wear the Pod comfortably and discreetly under your clothes You can carry the PDM separately in a backpack briefcase or purse With the OmniPod Insulin Management System you don t have to worry about snagging tangling or feeling tethered by tubing
33. connect a USB cable from your PDM or attempt to download your data to a computer using a non Windows based operating system as the PDM may alarm and require a reset When you connect a USB cable to the PDM only use a cable that is less than or equal to 9 feet 2 7 meters in length 15 Checking Your Blood Glucose The Built in FreeStyle Blood Glucose Meter We recommend that you test on your fingers if you are checking for hypoglycemia low blood glucose or if you suffer from hypoglycemia unawareness Blood from the fingertips may show changes in blood glu cose sooner than blood from other sites With the FreeStyle blood glu cose meter you can check your blood glucose on your finger hand forearm upper arm Illustration of thigh or calf Figure 7 1 test areas on the body You may also want to test for low blood glucose Checking with the FreeStyle blood glucose meter requires a very small sample size just 1 3 When you feel symptoms such as weakness sweating nervousness headache or confusion or 0 3 microliter of blood e When you have delayed a meal after taking insulin about the size of a pinhead When your healthcare provider advises you to do so Most healthcare providers rec ommend checking on your Keep the OmniPod Insulin Management System and hand arm or leg when blood the FreeStyle accessories away from young children glucose values are stable as they contain small pa
34. 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 Insulin Management System The System consists of the handheld wireless Personal Diabetes Manager PDM which programs the Pod with insulin delivery instructions and the compact lightweight Pod which is worn discreetly beneath clothing and delivers insulin based on instructions from the PDM The PDM contains a fully integrated blood glucose meter and is very similar in materials construction and appearance to a personal digital assistant The Pod features no tubing and virtu ally pain free automated cannula insertion Compliance The OmniPod Insulin Management System is manufactured and distributed by Insulet Corporation The company is committed to complying with all federal and state regulations If you have any questions or concerns regarding any of our activities please contact us at 1 800 591 3455 from outside the United States 781 457 5098 Supply Shipment Insulet Corporation contacts customers to schedule quarterly supply shipments approximately two weeks prior to delivery Inquiries Representatives are available to answer product related inquiries 24 hours per day at our toll free number 1 800 591 3455 from outside the United States 781 457 5098 For all other questions concerns or complaints please conta
35. does appear NOTE 2 Press Cancel The Pod beeps to confirm the bolus is canceled An on screen message tells you how much insulin was delivered before you canceled the bolus Figure 4 10 a 3 00p 2 11 Bolus canceled 1 00 u delivered OK 3 Press OK to return to the Status screen If your suggested bolus contains both a correction bolus and a meal bolus the correction bolus is always delivered first Bolus presets are bolus amounts that you program for frequent use For example if you often take the same bolus at lunchtime you can create a bolus preset for that amount and name it Lunch NOTE Bolus presets are available only when the suggested bolus calculator feature is turned Off If the suggested bolus calculator is turned On you can still use carb pre sets See Carb Presets on page 39 Create a bolus preset 1 A a oS On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Presets then press Select Choose Bolus presets then press Select Choose add new then press New To use the OmniPod System s default naming system simply press Next The default naming system automatically assigns program names in numerical order such as bolus 1 bolus 2 bolus 3 37 4 Understanding and Delivering Bolus Doses Or to give a different name to the program a Press the Up Down Controller buttons to enter the char acters
36. dressings red meat and whole milk dairy foods Fiber The indigestible part of plant foods Foods that are high in fiber include broccoli beans raspberries squash whole grain bread and bran cereal Fiber is a type of carbohydrate but does not raise blood glucose levels as other carbohydrates do Glucose A simple sugar also known as dextrose used by the body for energy Without insulin the body cannot use glucose for energy Hazard alarm Notification by the PDM that a dangerous condition exists Healthcare provider A professional who practices medicine or teaches people how to manage their health All healthcare providers are a resource for valuable diabetes management information 165 Hemoglobin A1c HbA1c A test that measures a person s average blood glucose level over the past 2 to 3 months Also called glycosylated hemoglobin the test shows the amount of glucose that sticks to the red blood cell which is proportional to the amount of glucose in the blood Hyperglycemia high blood glucose A higher than normal level of glucose in the blood generally 180mg dL or higher Hypoglycemia low blood glucose A lower than normal level of glucose in the blood generally 70mg dL or lower Hypoglycemia unawareness A condition in which a person does not feel or recognize the symptoms of hypoglycemia Infusing Introducing a liquid substance under the skin into the body Infusion site Place on the body w
37. edit an existing target BG time segment choose the segment then press Edit Use the Up Down Controller buttons to choose a new start time end time target BG value and correct above value correction threshold Press Next after each entry To add a segment choose add new then press New Use the Up Down Controller buttons to choose a start time end time target BG value and correct above value correction threshold Press Next after each entry When you have completed all the time segments you want press Done then Save Min BG for calcs minimum blood glucose value allowed for calculating boluses Use the Up Down Controller buttons to enter a new minimum BG then press Next Using the Personal Diabetes Manager 6 3 Insulin to carb IC ratio You can edit existing time seg c When you have completed all time segments press ments and add segments up to a total of four Done then Save a To edit an existing C ratio time segment choose the seg 4 Correction factor You can edit existing time segments and ment then press Edit Figure 6 6 Use the Up Down add segments up to a total of four Controller buttons to choose a new start time end time a To edit an existing correction factor time segment choose and IC ratio Press Next after each entry the segment then press Edit Use the Up Down Control ler buttons to choose a new start time end time and cor rection factor Press Next after each
38. highs and DKA avoid 110 M maximum basal rate 28 65 maximum boluS aeee 15 65 meal bolus 31 140 142 167 Medic Alert Foundation 162 Medic Alert tag cece eens 120 medical electrical equipment 149 152 Menus BG PISTO 42 6 oe aan 7 Food Dra oss eedavetcdedseccatensece 7 SUSDENG eatd chen T 7 173 menus Bolus basal calcs 00 000s 61 IOI seternieasaneseeeePeeseateleses 7 More actions c ecceeees 7 32 My records ccceceeeeeeeeees 7 LE ALE e EEA aise EE ETE 7 System setup cece cece eee 60 Temp basSal ccc ee eee eee 7 microwave OVenS ccc cece ence eee 75 Min BG for calcs 065 13 62 64 missed bolus reminder 66 68 More actions Menu 2eeees 32 IRS iter tetera tneeteies 120 multiple daily injections MDIs 167 multiple day trends BG history 101 N National Institute of Diabetes amp Digestive amp Kidney Disease NIDDK 162 normal DOIUS 0 cece eee eee 30 31 O OCCIUSION 00005 7 114 118 167 occlusion detected hazard alarm 127 OmniPod label symbols 00000s 147 OmniPod Setup Wizard 11 OmniPod Starter Kit 06 9 OmniPod System ec eee e ees 2 OmniPod Web site 0 008 xi one time temporary basal rate 23 CANCE EEE T EEE 24 enDi e
39. insulin See the warning on page x of the Introduction for insulins approved for use in the Omni Pod System NEVER use insulin that is cloudy it may be old or inac ARIS tive Failure to use rapid acting U 100 insulin or using insulin that is old or inactive may lead to hyperglyce mia or diabetic ketoacidosis DKA e Anunopened Pod e Alcohol prep swab If you are a first time OmniPod System user your healthcare provider will guide you through the steps for initializing and applying your first Pod Do NOT attempt to apply or use a Pod until you have been trained by your healthcare provider Use of the Sys tem with inadequate training or improper setup could put your health and safety at risk Deactivate the current Pod 1 On the Home screen use the Up Down Controller buttons to choose More actions then press Select 2 Choose Change Pod Figure 5 1 then press Select 3 Press Confirm Figure 5 2 to deactivate the current Pod IChangepod Press Confirm to Add BG reading begin the pod change Assign Edit BG tags process This will deactivate your current pod Back Select Back Confirm 44 Using the Pod 5 4 Ifan extended bolus or temporary basal or both are actively running you will see the message in Figure 5 3 Press Con firm to accept the cancellation 3 00p 2 11 Last BG 110 mg dL Or press Back to return to the More actions menu
40. insulin QAUGE cee eee eee ee 59 NESS aa 25 tde swt oetudecaaswseaees 119 INTE CUON onee aE ETER 56 106 infusion set automated insertion 2 infusion site 49 56 106 166 infusion site inspection 106 insulin 7 29 43 46 47 107 109 139 166 insulin action See duration of insulin action insulin delivery FOSUING ercran ene tees 56 SUSDCNG a s uscsaeutbestesncatees ad 55 insulin delivery records 97 99 insulin delivery continuous 1 insulin gauge ICON 2 eee ee eee 59 insulin on board IOB 29 31 140 142 166 insulin FESErVOIl 6 eee e eee eee 59 insulin rapid acting vs long acting 118 insulin to carb IC ratio x 13 29 63 64 166 interference a cscaxecncceeeenadee 148 International Association for Medical Assistance to Travelers 162 interruption in communication 75 IV Prep wipes cece eee ees 74 137 J Juvenile Diabetes Research Foundation International i44cs5ssdaevessesas 162 K ketoacidosis cceeeeeeeeeee See DKA KELONES watiuries sucess tacvons 95 118 167 L ACE aa Aai 84 lancing iia E S PEE AEA EEE EE 87 other locations 0 00 88 lancing device oeaan 83 88 long acting insulin 04 118 low battery alert 0000e 137 low blood glucose See hypoglycemia low reservoir alert 15 66 127 lows
41. is used to cover predictable short term changes in basal insulin need Temporary rates are often used during exer cise and for sick day insulin adjustments Temporary basal preset An adjustment in a basal rate in either or U hr that can be assigned a custom name and preprogrammed into the PDM Time segment see basal segment 168 activate a new Pod basal segment or rate bolus reminder user information advisory alarms airport security history records alert escalation 0000e 126 alerts and reminders 8 66 69 IO O ekeen e A 66 BG reminder c cece eens 66 confidence alerts 06 67 CUSTOM alerts cece cece eee 67 low reservoir cece cece eee 15 66 missed bolus cece eee es 66 Pod expiration cece eens 66 American Diabetes Association 162 aseptic technique 43 56 163 automated cannula insertion 2 52 B backlight time out 006 71 SCL E E eonteat ne 72 basal history c cece cece ee eees 98 basal program 12 17 23 163 add segment or rate 21 CODY liasa na erties cis a 22 ClO G eae oes E E fares 18 ac seem nee ee eee oer ee 23 edit segment or rate 21 Cha DIE ised china ones eaennconer en 20 FEM AING cote tecwet done tient aneden 22 basalrate 1 12 17 28 163 MAAN setae aE 28 temporal
42. it to your skin nore When you remove the needle cap a few drops of For the Pod to work best apply it insulin should be visible at the end of the needle 1 Crosswise or at a slight angle on your abdo men hip upper back or buttocks see A A B 2 Up and down or ata slight angle on your upper arm or thigh see B 3 Atleast one inch away from the last site 3 days However if necessary several products are available to enhance adhesion Ask your healthcare provider about these products Avoid getting body lotion creams or oils near the infusion site these products may loosen the adhesive The Pod s adhesive keeps it securely in place for up to 51 5 Using the Pod 4 After you securely apply the Pod press Next Figure 5 17 Insert cannula and begin insulin delivery 1 To insert the soft cannula press Start Figure 5 18 3 00p 2 11 Prepare infusion site 3 00p 2 11 Press Start to insert Remove needle cap and cannula and begin basal adhesive backing from delivery pod Place pod on your site and then press Next Next Start aa The adhesive is designed for one time use Once V removed a Pod cannot be reapplied If you are applying a Pod ina place that does not have a lot of fatty tissue or is very lean pinch the skin around the Pod Figure 5 19 after you press Start and hold it until the cann
43. lotion creams or oils near the infusion site these products may loosen the adhesive e Check for ketones when blood glucose is 250 mg dL or P y higher For some contact sports you may want to remove the Pod 119 9 Living with Diabetes Be sure to check your blood glucose levels before removing the Pod and after applying a new one Pods are designed for one time use Do not attempt to reapply a used Pod If possible avoid wasting Pods by planning removal TIP times that coincide with a scheduled Pod replace ment If you will need to remove the Pod for more than 1 hour ask your healthcare provider to recommend appropriate guidelines X rays MRIs and CT scans Som The Pod and PDM may be affected by strong radia NY tionor magnetic fields Before having an X ray MRI or CT scan or any similar test or procedure remove your Pod and put it and the PDM outside the treat ment area Check with your healthcare provider on Pod removal guidelines The Pod and PDM can tolerate common electromag netic and electrostatic fields including airport security and cellular phones NOTE Surgery or hospitalization For scheduled surgeries or hospitalization you should tell the doctor surgeon or hospital staff about your insulin Pod It may be necessary to remove it for certain procedures or treatments Remember to replace the basal insulin that was missed while the Pod was removed Your healthcare provider can help y
44. manage your list of tags and to add custom tags see Manage the Blood Glucose Tags List in Chapter 6 Using the Personal Diabetes Manager 91 7 Checking Your Blood Glucose Blood Glucose Results and the Suggested Bolus Calculator 4 9 3 00p 2 11 If the suggested bolus calculator feature is turned On when you Enter current BG check your blood glucose the PDM will display the result From here press Next to enter carbs if eating and have the System calculate a suggested bolus See Suggested Bolus Calculator in Chapter 4 Understanding and Delivering Bolus Doses 105 mg dl note Ifyou use the suggested bolus calculator within 10 Use for bolus calcs minutes after taking a blood glucose reading or if you store a BG reading for example one you enter manually within the same 10 minutes the BG value will be popu lated automatically for use in the suggested bolus Back No Yes calculator process Figure 7 34 note The Bolus Entry screen does not open if If the suggested bolus calculator feature is turned Off the Next we A regular bolus is currently in process soft key does not appear Instead The meter temperature is out of range Pr I n a screen wher n enter ess Bolus to open a screen where you can enter a bolus You have tagged this BG reading as a Control manually Or press Done to return to the Status screen to see the most e The BG reading is less than your Min BG for cal
45. mg dL in 1 mg dL incre Maximum basal rate 30 U hr use by the suggested bolus ments Default is 3 00 U hr cacuator Default is 70 mg dL Basal programs 7 Insulin to carb IC ratio k ns eels 1 to 1 g carb in 1g carb U increments aa ee Correction sensitivity 4time segments T to 300 mg dL factor in 1 mg dL increments Temp pasa presek i Reverse correction On or Off a Sga eats oron Default is On 30 minutes to 12 hours in 30 Duration of insulin action 2 to 6 hours in 30 minute incre minute increments ments Default is Off _ Default is 4 hours Blood glucose BG goal for Upper and lower limits 70 to 200 Bolus increment 0 05 0 1 0 5 or 1 0 units BG history mg dL in 1 mg dL increments Default isO 1 nite Blood glucose reminder On or Off maximum of 4 Maximum bolus size 30 units Reminder time of 1 to 4 hours after every bolus dose in 30 minute increments Default is Off Default is 10 units 143 Appendices Extended bolus Bolus presets Carbohydrate presets Suspend Low reservoir volume indicator Pod expiration alert Auto off alert PDM lock Screen time out Backlight time out History storage Language Units or Off 30 minutes to 8 hours in 30 minute increments Default is Off 7 36 30 minutes to 2 hours 10 to 50 units in 5 unit increments Default is 10 0 units 1 to 24 hours in 1 hour increments Default is 4 hours 1 to 24 hours or Off in 1 hour increments Default is Off On or
46. or 3 00p 2 11 Press Confirm to reset PDM to factory default settings This will delete all user settings History records will not be deleted Back Confirm A 3 00p 2 11 Cannot reset PDM while pod is active OK Use the form at the end of this User Guide to write down all your settings from the Setup Wizard You can also attach a copy of the pump therapy orders that you used during your training session If you ever need to reset your PDM having these settings handy will make setup very easy These forms are also available on Insulet s Web site MyOmniPod com Get the Most from Your PDM Keep it handy Wireless communication technology means you don t have to keep the PDM right next to the Pod for the Pod to work Once you set your basal program the Pod continues to deliver your basal program 24 hours a day regardless of the location of the PDM However you still need the PDM to deliver a bolus change the basal rate reference a food item and so on You can store the PDM conveniently inside an article of clothing like a shirt pocket or put it discreetly into a drawer briefcase or purse Communicating with the Pod When you use the PDM to communicate with the Pod hold the PDM within 24 61 cm of the Pod If you wear the Pod on your abdomen holding the PDM in your hands when pressing the buttons should be close enough Water and your PDM The PDM is not waterproof Do NOT
47. reach your healthcare ing on page x of the Introduction for insulins provider approved for use in the OmniPod System Syringes for injecting insulin Water and Your Pod Instructions from your healthcare provider about The Pod is watertight to a depth of 8 feet for up to 30 minutes how much insulin to inject if delivery from the IPX8 After the Pod gets wet rinse it off with clean water and dry Pod is interrupted it with a towel Blood glucose test strips Ketone test strips S Do NOT expose your Pod to water at depths greater than 8 feet or for longer than 30 minutes Check the Wy Lancing device and lancets infusion site often to make sure the Pod and soft can nula are securely applied and in place If the cannula is not properly inserted hyperglycemia may result Glucose tablets or another fast acting source of carbohydrate Alcohol prep swabs A copy of the letter from your healthcare pro EA The Personal Diabetes Manager PDM is not water vider for airline security see Minimize airport w proof Do NOT place it in or near water security delays later in this chapter 107 9 Living with Diabetes Traveling and Vacationing Plan for changing time zones If you re planning a vacation or business trip to a different time zone you may need to adjust your basal rate programs For changes of just a few hours basal rate adjustments are minor and easy to calculate For long distance travel however figu
48. subcategory then press Select Choose a food item from the subcategory then press View HI 3 00p 2 11 HI 3 00p 2 11 Food library Food library Bread muffins bagels Vegetables Cereals grain pasta Milk milk products Crackers snacks Sweets desserts other Beans peas lentils Meat meat substitutes Fruit fruit juices Fats Vegetables Combination foods Milk milk products Fast foods Sweets desserts other Free foods Done Index Select Done Index Select To choose from an alphabetical list of foods press Index Enter the first letter of the food item then press Select Choose a food item from the alphabetical list then press View The screen displays the food item s e Name Serving size e Grams of carbohydrate fiber fat and protein e Total calories 4 Press OK to return to the list of main food categories 42 Using the Pod Refer to the insulin labeling and follow your healthcare provider s The Pod Change Process directions for how often to replace the Pod If you like you can set the PDM to alert you when it is time to replace the Pod see Chapter 6 Using the Personal Diabetes Manager i WARNINGS Do NOT apply or use a Pod if its sterile packaging is open or damaged as this may increase the risk of infection Pods are sterile unless packaging has been opened or damaged Do NOT apply or use a Pod if it is damaged in any way A dam aged Pod may not work properly To minimize the
49. that spell the name you want An up and down arrow symbol on the screen indicates which character you are changing b Press the middle soft key labeled with the right arrow to move the underscore to the next character c Enter each character one at a time For example if you frequently take the same bolus at lunchtime you might enter L u n c h Figure 4 11 d Press Next A 3 00p 2 11 a 3 00p 2 11 Edit name Bolus presets Bunch enter manually x Lunch 2 20 u Back Next Back Select Enter the new bolus preset amount up to the maximum bolus you entered during setup then press Next Review the bolus preset name and amount press Save to accept it Enable an existing bolus preset 1 4 On the Home screen use the Up Down Controller buttons to choose Bolus then press Select Choose the bolus preset you want to use from the list Figure 4 12 then press Select Press Enter to confirm the bolus preset amount or if neces sary use the Up Down Controller buttons to adjust the bolus amount Press Confirm to deliver the bolus shown on the screen Change rename or delete a bolus preset 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Presets then press Select Choose Bolus presets then press Select Choose a preset from the list then press Edit 38 Understanding and Delivering Bolu
50. these programs also appear in the menu If message lets you know that insulin delivery is indeed sus these options appear choose Suspend insulin delivery pended Figure 5 24 The Pod beeps every 15 minutes until the end of the suspen sion period The Status screen shows INSULIN SUSPENDED until you resume insulin delivery see Resume Insulin Deliv ery below 55 5 Using the Pod At the end of the suspend time a Pod Advisory alarm occurs Figure 5 25 A 3 00p 2 11 fi m 300p 211 End of insulin suspend A Bolus e More actions gt Press Ok to resume E Tanoba basal rate delivery hie j b My records gt ST Settings gt Food library BG history amp Resume OK Status Select 4 Toresume your programmed basal rate press OK NOTE CEATA Insulin delivery will not resume until you press OK If V you do not press OK to resume insulin delivery you The Advisory alarm repeats every 15 minutes until you press OK could develop hyperglycemia high blood glucose Resume Insulin Delivery Onthe Home screen use the Up Down Controller buttons to choose Resume Figure 5 26 then press Select Press Confirm to restart the basal program for that time seg ment Avoid Infusion Site Infections Always wash your hands and use aseptic technique to pre pare the infusion site before applying a Pod Do not apply a Pod to any area of skin with an
51. underscore to the next character then press Next To use the same basal program for the entire 24 hour period press Save To edit or add segments to the newly copied basal program fol low the steps under To edit or add a segment or rate in the basal program earlier in this chapter Instead of suspending changing and then resuming 7 the active basal program try this Copy the active program rename it make the changes save it then enable it 22 Understanding and Adjusting Basal Rates 3 To delete a basal program 1 After choosing a program from the list choose Delete and then press Select 2 Press Delete to permanently delete the program NOTE As a Safety feature you cannot delete the active basal program Temporary Basal Rates and Presets What is a temporary basal rate A temporary basal rate lets you adjust your basal rate for a pre determined period of time On occasion you may need to change the active basal rate for only a short time For example if you are going cross country skiing for several hours you may want to lower the basal rate during and after you exercise This is called a one time tempo rary basal rate Some temporary changes are easy to predict and respond to They happen routinely and you may know from experience how they affect your insulin needs For example you might take the same exercise class twice a week for a few weeks or months or join asumme
52. with the not from any other Deliver an Extended Bolus The extended bolus feature lets the OmniPod System deliver some or no insulin now and the remainder over a period of time you choose Deliver an extended bolus instead of a normal bolus 1 After you get your suggested bolus press Extend instead of Enter see Figure 4 5 ak 3 00p 2 11 Suggested bolus 5 00 u Carbs 60 g BG 150 mg dL Insulin on board 0 00 u 5 00u Back Extend Enter 34 Understanding and Delivering Bolus Doses 4 note Ifyou have set the Extended bolus option to Off 3 Enter the time up to 8 hours in 30 minute increments over the PDM will not display the Extend soft key For which to deliver the remainder of the bolus then press Enter information on turning this feature on and off see Figure 4 7 In Figure 4 8 you can see a detail of the extended Chapter 6 Using the Personal Diabetes Manager bolus 2 Enter the units of insulin or percentage of the bolus that you want to take immediately Figure 4 6 then press Enter A ST A ETD Extended bolus 3 00 u Start bolus Extend for how long EREA 2 00u a 3 00p 2 11 Enter amount of meal aot 3 00v bolus to deliver now 1 O br Pe Meal 4 00 u Total 5 00u Correction 1 00 u 1 00uU lt Back Enter Back Confirm 4 Ifthe blood glucose reminders feature is turned On you can now set a blood glucose reminder Back En
53. 000 4 6 150 kHz to 80 Mhz be used no closer to any part of the OmniPod System than the recommended separation distance calculated from the equa Radiated RF 80 MHz 2 5 GHz 10V m tion applicable to the frequency of the transmitter as below IEC 61000 4 3 Recommended separation distance d 1 17 VP d 0 35 VP 80 MHz to 800 MHz d 0 7 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmit ter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compli ance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol i Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflections from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast 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 equipment is use
54. 15 I C ratio 3 units meal bolus Insulin on board calculation Duration of insulin action time since your previous correction bolus duration of insulin action previous correction bolus Example of insulin on board Duration of insulin action 3 hours Time since previous correction bolus 1 hour Previous correction bolus 3 units 3 hours 1 hour 2 hours 2 hours 3 hours 2 3 2 3 3 units 2 units IOB In other words one hour after your correction bolus you have received only 1 unit of insulin from your previous correction bolus 2 units of insulin are still working to correct your BG This feature prevents delivering too much insulin when correcting a high BG 140 Appendices Examples of suggested bolus calculations The examples below use these settings e Target BG 100 mg dL e Cratio 1 15 e Correction factor CF 50 e Duration of insulin action 3 hrs Example 1 Current BG level 150 mg dL Carb intake 0 grams of carbohydrate carbs Insulin on board 0 units Correction bolus 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 0 carbs 15 I C ratio 0 units Suggested bolus dose 1 correction 0 meal 0 IOB 1U Example 2 Current BG level 150 mg dL Carb intake 45 carbs Insulin on board 0 units Correction bolus 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 45 carbs 15 I C ratio 3 units
55. 800 591 3455 from outside the United States 781 457 5098 and Fax 877 467 8538 The claim must include the date of purchase model number serial number and a descrip tion of the claimed defect Insulet Corporation s authorization must be obtained prior to returning the PDM If authorized the PDM must be prop erly packaged and returned to Insulet Corporation Insulet Corporation will pay all freight and transportation charges where applicable incurred in shipping a PDM to be repaired or replaced under this Warranty Conditions Proof of Purchase in the form of a bill of sale or receipted invoice showing that the PDM is within the warranty period must be presented to obtain warranty service Exclusions This Warranty covers only the original purchaser and cannot be transferred with sale rental or other transfer of the PDM to any other person or entity Appendices THIS WARRANTY DOES NOT APPLY IF THE PDM HAS BEEN changed or modified by any person or entity other than Insulet Corporation e serviced or repaired by any person or entity other than Insulet Corporation e damaged by an act of God misuse abuse negligence accident wear and tear unreasonable use or by other causes unrelated to defective materials or workmanship Miscellaneous REPAIR OR REPLACEMENT AS PROVIDED UNDER THIS WARRANTY IS YOUR EXCLUSIVE REMEDY ANY APPLICABLE IMPLIED WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PAR
56. 98 79 7 Checking Your Blood Glucose Performing a Control Solution Test note Ifyou need to adjust the code number after the PDM 7 at ae fos a aman lane ues cn ae ma has moved to the next screen just press the Up Down 1 Grasp the bottom of the test strip with the name FreeStyle Controller buttons The code screen reappears and you facing up Figure 7 3 can adjust the number The code number remains on the PDM screen for your reference until you have completed the control test if Top to insert into meter FreeStyle test strip Code 27 so AS90I4 Bottom edges for blood sample 2 Insert the top of the test strip into the test strip port Figure 7 4 until it stops This turns on the PDM and displays the code number on the screen Nore Be ready to adjust the code on the PDM to match the code number on the test strip vial Figure 7 5 80 Checking Your Blood Glucose 7 From some PDM screens you cannot access the Free style blood glucose meter For example you cannot use the meter while you are activating a Pod or when 6 00p 211 an alert alarm or communication error screen is dis Apply a blood sample to played In these cases if you insert a test strip the the strip PDM beeps to alert you 3 To help you see the test strip port in reduced lighting when you insert a test strip into the PDM you can turn on the port lig
57. Alerts you if the PDM does not receive a Pod status within a predefined period of time Obtain Pod status by press ing and holding the PDM s Power button This alert can be especially reassuring if you are prone to hypoglycemia unaware ness Choose a time period from 1 to 24 hours in 1 hour increments or choose Off The default setting is Off EATON Turning the PDM on by inserting a blood glucose W test strip does not send a Pod status to the PDM SCAT Many hazard alarms such as Auto off will cause wW alert escalation and deactivation of the active Pod if you ignore them Be sure to respond to all alerts and alarms when they occur Bolus reminders Alerts you if you have not delivered a meal bolus manually or using the suggested bolus calculator between the times you specify Choose On or Off and choose up to 6 time segments Reminder alerts Pod beeps when a program is in process see Chapter 3 Understanding and Adjusting Basal Rates and Chap ter 4 Understanding and Delivering Bolus Doses for details These include e Temporary basal in process Extended bolus in process Choose On or Off The default setting is On 66 Using the Personal Diabetes Manager 6 Confidence alerts The Pod or PDM beeps in response to your 4 Choose the reminder or alert you want to set Figure 6 8 instructions so you become familiar with the operation of the then press Select OmniPod System and feel confident that you are gett
58. Configure the list of available BG tags v Ketones trace v Ketones small v Ketones moderate v Ketones large New 1 To hide or show a standard BG tag choose the tag and press Show if it is marked as hidden or Hide Tags you choose to show will be checkmarked hidden ones will not be 2 Toadd a custom tag choose add new at the end of the list of custom tags then press New In the Edit name screen either a Press Save to save the new tag with the default name custom tag1 custom tag2 and so on or b Use the Up Down Controller key to choose letters and numbers for a name followed by the middle soft key to move forward one space Then press Save 3 To delete a custom tag choose the tag press Delete then press Delete again Or press Cancel to leave the tag unchanged Change BG sound To change BG sound choose On or Off then press Select 70 Using the Personal Diabetes Manager 6 Customize the Personal Diabetes Manager Additional options let you customize how the PDM operates PDM lock Locks the buttons on the PDM The default setting is Off This safety feature can help avoid accidentally changing basal rates or giving boluses Screen time out The screen turns off after a time interval that you set which occurs if you have not pressed any buttons on the PDM This setting preserves battery power by turning off the screen when you are not using it Choose an interval o
59. Diabetes Manager Icons in the Appendices In addition pressing and holding this button for 2 seconds enables a bright mode on the PDM screen 1 Your New OmniPod Insulin Management System Primary screens Messages on the screen either Tell you how the System is operating e List menu choices Explain how to perform certain tasks The System s primary screens are the Status screen Figure 1 3 and the Home screen Figure 1 4 mr 50 U 3 00p 2 11 i 8 3 00p 2 11 LastBG 150 mg dL B Bous pone today iis Moreactions gt Last bolus 1 00u 1 00p today amp Temp basal I My records gt Foss ST Settings gt 070 Uhr Food library BG history amp Suspend Pod exp 9 37a 2 14 Home Status Select Status screen Lists the System s current operating status From top to bottom the Status screen displays Time date and result of last blood glucose checked or entered manually e Time date and total amount of last bolus delivered e Name and rate of active basal program or temp basal program e Ext bolus the amount of insulin and the delivery time remaining if an extended bolus is being delivered INSULIN SUSPENDED if insulin delivery has been suspended e Timeand date when the Pod will expire note Ifa Pod has not yet been activated as during Pod changes the screen displays No active Pod Would you like to activate a Pod now
60. Hazard Alarms 10 ffomthe Customer Care tabonourWeb site ec Se eee TPLA from the Customer Care tab on our Web site MyOmniPod com Empty reservoir Pod Press OK to acknow Among these resources are an online copy of this Insulin delivery stopped and ledge User Guide and the My OmniPod System Information Change pod now PDM Change Pod form which you will also find at the end of this guide Check blood glucose Occlusion detected Pod Press OK to acknow If the PDM cannot communicate with the Pod to accept or shut l ledge Insulin delivery stopped ge off a hazard alarm you can shut it off manually a sod 1 Remove the Pod from your body if you have not already cange PRONON eke sac done so Check blood glucose 2 Press the end of a paper clip or similar item into the manual Bodiexnirad Pod Press OK toacknow alarm shut off port on the top side of the Pod See Chapter a 7 ledge 11 Communication Failures Figure 11 17 Insulin delivery stopped l Change pod now Change Pod Check blood glucose Auto off Pod Press OK to acknow Remove pod now at ledge Change Pod Check blood glucose 127 10 Errors Advisories and Hazard Alarms SS CC Pod deactivation required PDM Press OK to acknow PDM Error Press OK to acknow Press Ok to deactivate ledge Press Ok to reset clock ledge Change Pod Reset clock Check blood glucose Check blood glucose Pod Error Pod Press OK to acknow PDM Error PDM Pre
61. Hematocrit 15 to 65 Measurement units mg dL Result range 20 to 500 mg dL Sample Whole blood capillary Sample size 300 nanoliters 1 3 or 0 3 microliter Test time Average of 7 seconds 146 Appendices OmniPod System Label Symbols Do not reuse this device single use only Storage temperature Caution Consult accompanying documents amp Do not use if package is damaged Consult instructions for use Personal Diabetes Manager Icons N oxx Epia Hre TERI Sterilized by ethylene oxide Manufacture date year month jl Expiration date use by date year month A Communication Reference model number reorder number PF Pod Podchange Podchange Communication failure Device serial number ST ae Ue Up Down Type BF medical device settings protection from electrical shock K Temp basal B Up Down on color Latex free ia 9 Suspend cancel Status Non pyrogenic fluid pathway only re TE REN y Records O ext entry rig Te e Watertight to 8 feet for 30 minutes A A aes alternating Apply blood sample Keep dry AL Hazard alarm Blood glucose records 6 gt lt co Ay 147 Appendices A N oman Q PDM lock Battery full mar Battery 3 4 ful E gt Battery half full fe Battery 1 4 full ma Battery empty H Basal program Food library Lost history User Information record Support Unconfirmed Y soye PE C Delivery Spans i Active default
62. MyOmniPod com Contacts and Important Information Use the spaces below to record important health and product information Name Address Telephone and Fax Email Address Name Address Telephone and Fax Email Address Name Address Telephone Number s Policy Number Name Address Telephone and Fax Email Address Script Name Dose Frequency OmniPod System Start Date PDM Model UST200 Serial Number Emergency Services Dial 911 USA only not available in all communities Insulet Corporation 9 Oak Park Drive Bedford MA 01730 Customer Care 24 hours 7days 800 591 3455 When calling from outside the United States 781 457 5098 Customer Care Fax 877 467 8538 Web Site MyOmniPod com a OmniPod gt eee Insulin Management System Model UST200 2009 Insulet Corporation All rights reserved OmniPod is a registered trademark of Insulet Corporation U S Patent No 6 740 059 FreeStyle is a registered trademark of Abbott Laboratories Windows is a registered trademark of Microsoft Corporation Contents troduction 0 5c5i0 5 iacsewasesie ia aa iX Before You Get Started isss rarr iraan ane A ix Macaon seess tea artant E E N iX CONtrAINGICATIONS eessen N ix You and your healthcare provider cccceeeeeeeeees X Your Role Safely Using the OmniPod System xi About This User Guide ccc cece ence e cece eeeeenes xii Conventions ANd TerM
63. Off Default is Off 10 20 or 30 seconds Default is 20 seconds 5 10 or 20 seconds or Always on Default is 10 seconds 5400 records 90 days English Pod Specifications Size 1 6 wide x 2 4 long x 0 7 high 4 1cm x 6 2cm x 1 7cm Weight with full reservoir 34 grams 1 2 oz Operating temperature range 40 F to 104 F 5 C to 40 C Under normal circumstances your body temperature will keep the Pod well within this range Startup temperature above 50 F 10 C Storage temperature range 14 F to 122 F 10 C to 50 C Reservoir volume deliverable 200 units Cannula insertion depth 6 5mm Watertight rating PX8 8 feet for 30 minutes Insulin concentration U 100 Alarm type Audible Operating relative humidity range 20 85 noncondensing Storage relative humidity range 20 85 noncondensing Operating atmospheric pressure 700 hPA to 1060 hPA Storage atmospheric pressure 700 hPA to 1060 hPA Delivery accuracy tested per IEC 60601 2 24 Basal 5 at rates gt 0 1 U hr Bolus 5 for all set values gt 0 1 units 144 Accuracy Test Results The following graphs are designed to show flow accuracy of the Pod against given time periods Flow rate from startup The following graph shows changes in the flow rate over the stabilization period The measurements were made using a Pod with a basal rate of 1 0 U h at high operating temperature 2 00 Actual Flow Rate
64. Pod System s default naming system simply press Next The default naming system automatically assigns program names in numerical order such as carb preset 1 carb preset 2 carb preset 3 Or to give a different name to the program a Press the Up Down Controller buttons to enter the char acters that spell the name you want An up and down arrow symbol on the screen indicates the character you are changing 39 4 Understanding and Delivering Bolus Doses b Press the middle soft key the right arrow to move the 7 Enter the grams of carbohydrate in the meal then press Next underscore to the next character 8 Ifyou want enter the grams of fiber fat and protein in the c Enter each character one at a time For example if you meal and the total calories Press Next after each entry frequently eat a breakfast of plain low fat yogurt with O l l blueberries sweetener and cinnamon you might enter note These additional units are not required If you prefer not B u e space Y o g u r t Figure 4 13 to enter them simply press Next repeatedly to step through the screens note lf you do include grams of fiber in step 8 above the PI 3 00p 2 11 Ld 3 00p 2 11 p suggested bolus calculator uses carbs minus fiber Alter Edit name Carb presets natively in step 7 you can enter the total of carbs minus Blue Yogurt Favorites fiber yourself Your healthcare provider can best advise saaks S you how to make t
65. Pod is watertight to a depth of 8 feet for up to 30 minutes IPX8 After exposure to water rinse off the Pod with clean water and gently dry it with a towel Do not expose your Pod to water at depths greater than 8 feet or for more than 30 minutes Check often to make sure the Pod and soft cannula are securely attached and in place If the cannula is not properly inserted hyperglycemia may result The PDM is not waterproof Do not place it in or near V water Safe storage Store unopened Pods in a cool dry place Extreme heat or cold can damage Pods and cause them to malfunction If Pods are exposed to extreme temperatures allow them to return to room temperature before use Pods are sterile unless their packaging is opened or damaged Do NOT apply or use a Pod if its sterile packaging is opened or damaged as this may increase the risk of infection or serious injury 57 Using the Personal Diabetes Manager When a Pod is active and the PDM is turned on the PDM estab The Status Screens lishes Communication with the Pod to obtain a status check During the status check the PDM collects information from the Pod about bolus deliveries active basal programs and Pod expi ration The information obtained is then displayed in the status screen which shows the System s current operating status The Status screen Figure 6 1 displays Time date and result of last blood glucose checked or entered manually
66. S ccc cceeeeeccceeeeeceeeeeneees xii NADOS e A A O xii 1 Your New OmniPod Insulin Management System 1 Insulin Delivery with the OmniPod System 6 1 How Does the OmniPod System Work ceee ees 2 NOUD reassess riseire ae E UNTE ERA 2 Automated cannula insertion ceeeeeceeeeeeeeeees 2 A fully integrated design with blood glucose monitoring 2 Suggested bolus calculation ccc cece cece cence eees 3 Reference food library and carb presets cceeeeees 3 Record Keeping cece cece ccc ceeececeeneeeeeneeeeeueeees 3 Personalizing your System c cece cece cece ceeeeeeeeeeas 3 WNC ROO ics ecu aE le weinectaen tauren roan 4 The Personal Diabetes Manager 0cececeeeeeees 4 Buttons that program and control the OmniPod System 5 Primary SCKCCMS icons recat Gates aaa a a a ai 6 Safety Features ena Aa ONET 7 Automatic priming safety checks and insertion 7 Rapid occlusion Aetection cece cece cceeeceeneeeenes 7 Alerts ANG AlANINS 344945450 s aks Jota a a 8 Getting Started o45ivcscendevcuiseasesindespaleweaeneee 9 The OmniPod Starter Kit reres eee eee ence eeees 9 Set Up the Personal Diabetes Manager PDM 10 Tumron the PDM eein rea eaea EE NTA 10 The OmniPod Setup Wizard cc ccc cece cece ee eens 11 SEC date and TMC is sacswisi Hind awe oben tama Leesa tence 11 Enter Basal se
67. S ic a6 eocaerew tas aekanwiwotaademenede 162 Glossa yos eainiie Gedenssisse ses eee ews 163 INGOX E E T E EE T T 169 viii Introduction Before You Get Started aS TI US Federal law restricts this device to sale by or on V V the order of a physician Indication The OmniPod Insulin Management System is intended for sub cutaneous below the skin delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requir ing insulin and for the quantitative measurement of glucose in fresh whole capillary blood in vitro Contraindications Insulin pump therapy is NOT recommended for people who are either e Unable to perform at least four 4 blood glucose tests per day e Unable to maintain contact with their healthcare provider e Unable to use the System according to instructions Do not use the integrated FreeStyle Blood Glucose Monitoring System for Testing on newborns e Testing arterial blood e Diagnosing diabetes EATON This User Guide is intended for use only with PDM W model UST200 To learn which version of the PDM you have turn it over On the back of the PDM look for the symbol If you see UST200 to the right of it this is the correct User Guide If you do not see UST200 please call Customer Care immediately to receive the correct User Guide 800 591 3455 When calling from outside the United States 781 457 5098 If you are unable
68. Setup Wizard Using the System setup menu you can edit all the OmniPod System bolus and basal set tings as your needs change Check with your healthcare provider Back 12 24hr Enter Cancel Confirm before making any changes 3 Press Confirm to accept the new time Figure 6 4 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Reset the date 2 Choose System setup then press Select 1 Press the Up Down Controller buttons to choose the cur 3 Choose Bolus basal calcs then press Select rent year then press Next 2 Choose the current month then press Next 3 Choose the current day then press Next 61 6 Using the Personal Diabetes Manager 4 Choose one of the options Figure 6 5a and Figure 6 5b then press Select Each option is described below Bolus calcs Off Extended Units Bolus increment 0 05 u Max bolus 8 00 u Max basal 1 50 uhr Back Select or 3 00p 2 11 Temp basal U hr or 3 00p 2 11 Bolus calcs On Ratios factors targets Temp basal U hr Extended Units Bolus increment 0 05 u Max bolus 8 00 u Max basal 1 50 uhr Back Select Bolus calcs When the suggested bolus calculator is turned Off and you want to turn it On press On and follow these steps 1 Target BG and correct above value You can edit existing time segments and add segments up to a total of four a To
69. TICULAR PURPOSE ARE LIMITED IN DURATION TO THE DURATION OF THIS WAR RANTY IN NO EVENT SHALL INSULET CORPORATION ITS SUPPLIERS OR ITS DISTRIBUTORS BE LIABLE FOR CONSEQUENTIAL OR INCIDENTAL DAM AGES FOR BREACH OF ANY EXPRESS OR IMPLIED WARRANTY ON THE PDM Some states do not allow limitation on how long an implied warranty lasts and some states do not allow the exclusion or limitation of conse quential or incidental damages so the above limitations or exclusions may not apply to you This Warranty gives you specific legal rights and you may also have other rights which vary from state to state This Warranty is valid only in the United States No Other Warranty Unless modified in writing and signed by both parties this Warranty is understood to be the complete and exclusive agreement between the par ties superseding all prior agreements oral or written and all other communications between the parties relating to the subject matter of this agreement No employee of Insulet Corporation or any other party is authorized to make any warranty in addition to those made in this Warranty 155 Appendices HIPAA Privacy Notice THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO IT PLEASE REVIEW IT CAREFULLY This notice of privacy practices the HIPAA Privacy Notice describes how we may use and disclose your Medical Information to carry out treatment payment or health
70. We recommend that you start atlevel2for yoy are now ready to perform a blood glucose test most sites except the finger Insert the blood glucose test strip 1 Insert a new blood glucose test strip into the test strip port until it stops The test strip port is at the bottom of the PDM style blood glucose meter For example you cannot use the meter while you are activating a Pod or when an alert alarm or communication error screen is dis played In these cases if you insert a test strip the PDM beeps to alert you From some PDM screens you cannot access the Free 2 Tohelp you see the test strip port in reduced lighting press the middle soft key labeled Light To turn the light off press 4 Light again _ To lance your finger we recommend that you start at level 1 the shallowest Be sure to use the gray cap 85 7 Checking Your Blood Glucose 3 Insert only the top end of the strip into the test strip port with the dark colored rectangle going into the meter Figure 7 17 and Figure 7 18 i Top Ty g E O op o Bottom NOTE Ifyou do not start the test within 2 minutes the PDM powers off To restart the PDM take out the unused strip and reinsert it or simply press and hold the Power but ton to turn on the PDM Set the blood glucose test strip code After you insert the strip the PDM displays a code number Figure
71. about you provided however that applicable law may limit your ability to inspect or copy certain types of records In certain circumstances if we deny your request to review Medical Information you may have a right to have this decision reviewed If you would like to make a request to review your Medical Information please download our Request Form at http www myomniPod com images upload HIPAA_Privacy_Notice_Request_Form pdf and follow the directions included on that form We will respond to your request in a reasonable amount of time If your request is honored we may charge a nominal fee for photocopying expenses Please contact our Privacy Officer if you have questions about access to your Medical Information You May Have the Right to Amend Your Medical Information If you believe that the Medical Information we have about you is incorrect or incomplete you may ask us to make an amendment to your Medical Information You may request an amendment as long as the Medical Information is still maintained in our records If you would like to make a request to review your Medical Information please download our Request Form at http www myomniPod com images upload HIPAA_Privacy_Notice_Request_Form pdf and follow the directions included on that form We will respond to your request in a reasonable amount of time Please contact our Privacy Officer if you have questions about requesting an amendment to your Medical Informatio
72. active infec tion If you are unsure whether to use a specific site ask your healthcare provider At least once a day use the Pod s viewing window to check the site for signs of infection and to confirm that the soft can nula is securely in place Be aware of the signs of infection including pain swelling redness discharge or heat at the site If you suspect an infec tion immediately remove the Pod and apply a new one ina different location Then call your healthcare provider Change the Pod as instructed by your healthcare provider 56 Using the Pod 5 Get the Most From Your Pod Avoid extreme temperatures The Pod s operating temperature is between 40 F and 104 F between 5 Cand 40 C Under normal circumstances your body temperature will keep the Pod well within this range Soa Do NOT expose a Pod to direct sunlight for long peri NY ods of time It is recommended that you 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 Remember to check your blood glucose levels frequently before and after removing the Pod Check with your healthcare provider for guidelines on removing the Pod for extended periods NOTE NOTE Insulin degrades at high temperatures and will freeze near 32 F 0 C Check the insulin manufacturer s instructions for use Water and your Pod The
73. ain If the PDM still cannot send the instruction you will see Figure 11 7 again Follow step 2 131 11 Communication Failures 2 Press Discard The PDM will consider the Pod lost and ask whether you want to activate a new Pod note Ifyou have an unconfirmed correction bolus when you W discard a Pod then the bolus calculator will be temporar ily disabled In this situation the bolus calculator is dis abled until the duration of insulin action period passes Figure 11 8 If you have any questions call Insulet Cus tomer Care 800 591 3455 24 hours 7days from outside the United States 781 457 5098 A 300p 2m Due to a recent clock reset or unconfirmed bolus information bolus calculations cannot be used until 6 59p OK Failure During Request for Status If you turn on the PDM or press Status and the PDM cannot communicate with the Pod it displays a communication icon Figure 11 9 Below the icon is a soft key labeled Skip Either 1 Wait until you see the Pod status not available screen Figure 11 10 re 3 00p 2 11 LA mm 3 00p 2 11 Last BG 150 mg dL 1 02p today Last bolus 1 00u D 1 00p today Pod status not available Last status today 3 00p Pod exp 9 38a 2 14 Skip Status Home Or press Skip to skip the communication process and imme diately bring up Figure 11 10 132 Communication Failures 11 note If the Pod has expired
74. ain 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 Additional Categories of Uses and Disclosures Required by Law We may use or disclose your Medical Information to the extent that applicable law requires the use or disclosure of such Medical Information Where the use and or disclosure of Medical Information is by law the use or disclosure will be made in compliance with the law and will be limited to the relevant requirements of the law You will be notified as required by law of any such uses or disclosures Appendices Public Health We may disclose your Medical Information for public health activities and purposes to a public health authority that is permitted by law to collect or receive the information The disclosure will be made for the purpose of controlling disease injury or disability We may also disclose your Medical Information if directed by the public health authority toa foreign government agency that is collaborating with the public health authority Communicable Diseases We may disclose your Medical Information if authorized by law to a person who may have been exposed to a co
75. alphabetically and by category You can also enter your own favorite foods snacks or entire meals as carb presets Presets contain the grams of carbohy drate in the food item or meal Next time you eat this same food you don t have to count the carbs just select your carb preset and the System does the calculating for you The System stores up to 36 carb presets Record keeping Another convenient part of the OmniPod System is record keep ing Paper charts are useful but sometimes they can be inconvenient to carry or use The data storage system in the Personal Diabetes Manager PDM displays up to 90 days worth of information This includes blood glucose readings basal rates and bolus doses carbohydrates and alarms Personalizing your System You can personalize your OmniPod System in other ways too Enter and name basal programs Name and save temporary basal presets e Add your own customized reminders Enter your name phone number doctor s names and numbers and other emergency information 1 Your New OmniPod Insulin Management System The Pod The Pod Figure 1 1 is applied to your skin with an adhesive backing similar to a Band Aid Top Bottom Fill port Adhesive backing Viewing window Needle cap The Personal Diabetes Manager All Pod operations are programmed and controlled through the palm sized Personal Diabetes Manager PDM Figure 1 2
76. and Hazard Alarms 10 Meter Error 3 See user manual for further instructions Meter Error 4 See user manual for further instructions Meter Error 6 See user manual for further instructions Incorrect test procedure For example putting blood on the test strip before inserting the test strip into the meter or applying blood before the Blood Drop and Test Strip symbols display Problem with the test strip Problem with the meter Problem with the test strip Problem with the meter Blood sample was applied while the code number was being changed 1 Be sure you see the Blood Drop and Test Strip symbols on the display screen before you apply blood or control solution Conduct a control solution test using a new test strip If the results of the control solution test are within the range printed on the side of the test strip vial retest using blood and a new test strip Ifthe control solution test does not work or the error persists call Customer Care at 800 591 3455 from outside the United States 781 457 5098 Conduct a control solution test using a new test strip If the results of the control solution test are within the range printed on the side of the test strip vial retest using blood and a new test strip Ifthe control solution test does not work or the error persists call Customer Care at 800 591 3455 from outside the United States 781 457 5098 Retest using a new te
77. and IC ratio Press Next after each entry 64 Using the Personal Diabetes Manager 6 c When you have completed all time segments press Done then Save 4 Correction factor You can edit existing time segments and add segments up to a total of four a Toeditan existing correction factor time segment choose the segment then press Edit Use the Up Down Control ler buttons to choose a new start time end time and cor rection factor Press Next after each entry b To add a segment choose add new then press New Use the Up Down Controller buttons to choose a start time end time and correction factor Press Next after each entry c When you have completed all time segments press Done then Save 5 Reverse correction Choose On or Off then press Select 6 Insulin action duration Use the Up Down Controller buttons to choose a duration of insulin action then press Enter Temp basal Choose U hr or Off to set the mode for temporary basal rates and presets then press Select Extended Choose Units or Off to set the mode for extended boluses then press Select Bolus increment Choose 0 05 0 10 0 50 or 1 00 units for bolus increments then press Select Max bolus Use the Up Down Controller buttons to enter the maximum bolus dose you can take then press Enter Max basal rate Use the Up Down Controller buttons to enter the maximum basal rate you can choose then press Enter
78. applied blood glucose BG reading is below the minimum BG you l l have set for bolus calculation see Chapter 2 Getting Started Ifyou increase a suggested bolus the increase is applied to and Chapter 6 Using the Personal Diabetes Manager the meal bolus unless there is no meal bolus in which case it The System suggests a correction bolus only when your BG is applied to the correction bolus reading is above the correction threshold or correct above e If you decrease a suggested bolus the decrease is applied to value you have set see Chapter 2 Getting Started and the meal bolus until it reaches zero then it is applied to the Chapter 6 Using the Personal Diabetes Manager correction bolus If there is no meal bolus the decrease is Insulin on board active insulin is subtracted first from a cor applied to the correction bolus rection bolus if any until it is zero At that point the remain ing insulin on board is subtracted from the meal bolus e The calculated insulin on board is rounded up to the nearest 0 05U 142 Appendices OmniPod System Options and Settings Time 12 hour or 24 hour clock Blood glucose meter sound On or Off Default is 12 hour Default is On Date MM DD YY Suggested bolus calculator On or Off DD MM YY Default is On MM DD YY Target BG value and 4 time segments 70 to 200 mg dL DD MM YY correction threshold in 1 mg dL increments Default is MM DD YY Minimum BG allowed for 50 to 70
79. apply blood to both edges Figure 7 28 Only use strips 1 Make sure that the strip is in the PDM and the PDM is pow once Discard used strips ered on If the PDM has powered off take out the strip and The strip acts like a sponge and pulls the blood into the strip reinsert it Figure 7 26 or simply press and hold the Power through the edge Figure 7 29 button to turn on the PDM mm Ty Q D U lt O Edge of test strip 89 7 Checking Your Blood Glucose Do not Press the strip against the test site Scrape the blood onto the strip Apply blood to the flat side of the strip Apply blood to the strip when it is out of the meter Put blood or foreign objects into the test strip port Wait for the reading 1 Do not lift up the strip until you hear 1 beep or see the word Checking on the screen Figure 7 30 This means you applied enough blood and the meter is reading your glucose 300p 2m 300p 2 11 AN Checking mg dL in E Calibration code 27 Done Tag Next If after 5 seconds the PDM does not display Checking the sample may be too small If needed add more blood to the same edge of the strip for up to 60 seconds from the time of the first application The strip port light turns off when the blood sample is accepted The reading is complete when you hear 2 beeps if BG sound is turned On and the PDM shows your reading on the sc
80. arm hand thigh and calf You may see differences in blood glucose measurements between the other test sites and your finger or palm at the base of the thumb after eat ing insulin medication or exercise You may see changes in blood glucose in blood samples from the finger or palm at the base of the thumb sooner than in blood samples from the forearm and other alternate sites Vigorous rubbing of the alternate test sites before lanc ing helps to minimize these differences Intravenous therapy solutions such as some immunoglobu lin preparations and peritoneal dialysis solutions containing icodextrin or compounds of Galactose 13 mg dL Maltose gt 20 mg dL or Lactose 10 mg dL can cause overestimation of blood glucose results The lancing device is for individual use only and must not be shared 96 Understanding Your Records E Record Keeping Therecordforthis item has been lost Record keeping is an important part of successful diabetes man nore lf the PDM can no longer mine Aian agement The Personal Diabetes Manager PDM helps simplify active Pod then you must activate a new Pod The PDM may not be able to communicate with the active Pod because of signal interference or because you have discarded the Pod If you change the Pod If the PDM batteries run out data in the memory is at without getting a Status update any unconfirmed risk Do NOT remove the old batteries until you have records will be
81. ater aaa 23 operating temperatures 75 144 146 options BONUS CalGS sii Sukasetdaaiei sles sues 62 EXTERNE scccuiesieedeadsorveeden 65 Max basal rate 0 eae 65 Wane DOIUS sorient 65 Ratios factors targets 64 TEMP Dasal vssadevesewaneesasenets 65 Options and settings 143 order SupplieS cc cece eens 139 P POM aE 4 58 75 backlight time out 71 batterieS cc cece eee 10 137 BG QOaliinesociekGloteusinann riers 69 blood glucose sound 70 ClEANING aarre varia i 137 communication with Pod 129 135 CUSTOMIZE erreser see teecds snes 71 72 a 0 6 01210 PEENE PETET ene E nn 139 ICONS naen EE neues 147 PINGOCK vnssinecodeuwevtess 71 72 136 PDM options 0ce eens 71 repair or replacement 126 screen time out 6 71 72 SCUINGS s daccstmdeveay hehe dcnsdew wees 59 SOLU hes see ouda ced E TETEA 10 Specifications cece ees 146 Storage esaea ne ba eines eee 136 submerged in water 74 VEISION sac iureaeseeseuandadwaians ahs iX PDM error hazard alarm 126 128 personal contact information 103 Personal Diabetes Manager See PDM physical exertion ec eens 119 playing Sports e cece ee eee 119 POG aah a E wewaannuce 4 43 57 174 ADDIVING dirr n A 51 change ProCeSs 0 cece eens 43 check SLAtUS i555 dew Eaa 54 CICANIING
82. blood glucose to the BG goal 2 If your blood glucose is 250 mg dL or above check for ketones If ketones are present follow your healthcare provider s guidelines 3 If ketones are not present take a correction bolus as pre scribed by your healthcare provider 4 Check blood glucose again after 2 hours If blood glucose levels have not decreased take a second bolus by injection using a sterile syringe Ask your healthcare provider whether to inject the same amount of insulin as in step 3 lf you feel nauseated at any point check for ketones and call your healthcare provider immediately see Diabetic ketoaci dosis DKA later in this chapter If blood glucose remains high after another 2 hours a total of 4 hours replace the Pod Use a new vial of insulin to fill the new Pod Then e Contact your healthcare provider for guidance Drink eight ounces of water every 30 minutes until blood glucose is within BG goal If you need emergency attention ask a friend or family member to take you to the emergency room or call an ambulance Do NOT drive yourself Investigate possible cause for hyperglycemia to avoid similar problems in the future see Possible causes of hyperglyce mia high blood glucose below 115 9 Living with Diabetes Possible causes of hyperglycemia high blood glucose Expired insulin Insulin exposed to extreme temperatures Infusion site in or
83. bout setting tem porary basals see Chapter 3 Understanding and Adjusting Basal Rates NoTE You can add up to 7 basal programs and set 24 segments per program Enter blood glucose sound setting and BG goal 1 To set the sound for the blood glucose meter choose On or 2 Off then press Next Use the Up Down Controller buttons to enter the lower limit for your blood glucose BG goal then press Next Enter the upper limit for your BG goal then press Next NOTE Press Save to accept the BG goal NOTE The lower and upper BG limits are only used when viewing BG History see Chapter 8 Understanding Your Records Check with your healthcare provider before adjusting these settings Set the suggested bolus calculator 1 To set the suggested bolus calculator feature choose On or Off then press Next NOTE lf the suggested bolus calculator is set to On perform the following steps If set to Off you will be prompted to Select bolus increment and Enter maximum bolus Getting Started 2 Enter target blood glucose value 1 Use the Up Down Controller buttons to enter a target blood glucose BG value then press Next Use the Up Down Controller buttons to enter the correct above value or correction threshold the BG value above which you want the PDM to suggest a correction bolus then press Next NOTE If the suggested bolus calculator is On a correction bolus will be suggest
84. breath odor and rapid breathing It is important to rule out ketoacidosis when you experience symptoms that might otherwise indicate the flu Ketones Acidic by products that result from the breakdown of fat for energy The presence of ketones indicates that the body is using stored fat and muscle instead of glucose for energy Meal bolus also known as carbohydrate bolus An amount of insulin administered before a meal or snack to ensure that blood glucose levels stay within the desired BG goal after a meal The OmniPod System calculates a meal bolus by dividing the grams of carbohydrates you are about to eat by your insulin to carbohydrate ratio Multiple daily injections MDIs Introducing insulin into the body with a syringe several times a day Occlusion A blockage or interruption in insulin delivery Prime bolus An amount of insulin used to fill the cannula preparing it to begin delivering insulin under your skin Protein One of the three main energy sources in food the other two are carbohydrate and fat Protein is necessary for the growth main tenance and repair of body cells and tissues Protein contains 4 calories per gram Foods high in protein include meat poultry fish legumes and dairy products Reverse correction negative correction Using an individual s correction factor sensitivity factor the reverse correction is a calculation that reduces a portion of a meal bolus dose when the patient
85. care operations and for other purposes that are permitted or required by law including by the Health Insurance Portability and Accountability Act HIPAA and all regulations issued thereunder It also describes your rights to access and control your Medical Information As used herein Medical Information is information about you including demographic information that may identify you and that relates to your past present or future physical or mental health or condition and related health care services Uses and Disclosures of Medical Information We will only use and disclose your Medical Information as permitted by law Except for disclosures outlined in this HIPAA Privacy Notice and or permitted by law we will obtain your written authorization before using your Medical Information or disclosing it to any outside persons or organizations You may revoke any written authorization you have provided to us at any time except to the extent that we have made any uses or disclosures of your Medical Information in reliance on such authorization To revoke a previously issued authorization please send your request in writing along with a copy of the authorization being revoked to our Privacy Officer If a copy of the applicable authorization is not available please provide a detailed description and date of the same to our Privacy Officer There are some situations in which we may use or disclose your Medical Information without
86. cking Pod status again or press Discard to begin the deactivation process 3 Ifat any point in this process the PDM can communicate again with the Pod you will see either a Figure 11 5 indicating that your original instruction or command was successfully sent to the Pod When you press OK or within 5 seconds the System displays the next screen in the command sequence you were entering b Figure 11 6 indicating that your last command was not sent to the Pod Press OK If you were activating a Pod the System returns to the pre vious screen where you can continue activation If you were issuing any other command the System returns to the Status screen where you can reissue the command A 3 00p 2 11 Communication successful OK x 3 00p 2 11 Communication error Last bolus command not received Refer to settings or history screens to review last action Communication Failures 11 Failure During Pod Deactivation To review the deactivation process see Deactivate the current Pod in Chapter 5 Using the Pod If you press Confirm to deactivate the active Pod and the PDM cannot send your instruction to the Pod you will see the screen in Figure 11 7 e 300p 2 11 Communication error Remove pod To retry deactivation press Retry Otherwise press Discard Retry Discard Either 1 Press Retry to try deactivating the Pod ag
87. clusion may result from a blockage Pod mal function or from using old or inactive insulin If insulin delivery is interrupted by an occlusion check your blood glucose level and follow the treatment guidelines established by your healthcare provider Hyperglycemia could result if appropriate actions are not taken Symptoms of hyperglycemia high blood glucose Fatigue Frequent urination especially during the night Unusual thirst or hunger Unexplained weight loss Blurred vision Slow healing of cuts or sores Hyperglycemia symptoms can be confusing Always check your blood glucose before you treat for hyperglycemia 114 Living with Diabetes 9 To avoid hyperglycemia high blood glucose Check your blood glucose at least 4 6 times a day when you wake up before each meal and before going to bed In addi tion always check it e Ifyou feel nauseated or sick Before driving a car Whenever your blood glucose has been running unusually high or low e Ifyou suspect that your blood glucose is high or low e Before during and after exercise e Asdirected by your healthcare provider To treat hyperglycemia high blood glucose Always check your blood glucose levels frequently while treating hyperglycemia You don t want to over treat the condition and cause your BG level to drop too far 1 Check your blood glucose level The result will help you to find out how much insulin is needed to return your
88. command authorities ii for the purpose of a determination by the Department of Veterans Affairs of your eligibility for benefits or iii to foreign military authority if you are a member of that foreign military service We may also disclose your Medical Information to authorized federal officials for conducting national security and intelligence activities Workers Compensation We may disclose your Medical Information as authorized to comply with workers compensation laws and other similar legally established programs Inmates We may use or disclose your Medical Information if you are an inmate of a correctional facility and your physician created or received your Medical Information in the course of providing care to you 158 Appendices Required Uses and Disclosures Under the law we must make disclosures to you when required by the Secretary of the Department of Health and Human Services to investigate or determine our compliance with the requirements of HIPAA Nonidentifiable Information We may use or disclose your Medical Information if we have removed from it any information that is personally identifiable to you Your Rights The following is a statement of your rights with respect to your Medical Information and a brief description of how you may exercise these rights You Have the Right to Inspect and Copy Your Medical Information This means you may inspect and obtain a copy of Medical Information
89. cs recent BG result e Insulin is suspended The BG result either from the PDM or from manual entry is stored in the System s history whether suggested bolus calcula tor is turned On or Off See Blood Glucose Records in Chapter 8 Understanding Your Records 92 Checking Your Blood Glucose 7 Entering Blood Glucose Readings Manually Editing Tags You can enter blood glucose readings manually into the PDM Within 2 hours of a blood glucose reading you can remove or This is particularly helpful if you use a separate blood glucose change a tag or add one However you cannot alter a Control tag meter 1 Onthe Home screen use the Up Down Controller buttons 1 On the Home screen use the Up Down Controller buttons to choose More actions then press Select to choose More actions then press Select 2 Choose Assign Edit BG tags then press Select 2 Choose Add BG reading then press Select 3 Use the Up Down Controller buttons to choose a reading 3 Use the Up Down Controller buttons to enter the BG read then press Tag Figure 7 35 A User Info Support icon is ing from your separate meter shown to the right of any reading to which you have already assigned one or two tags FF To enter a LOW reading press the Up Down 7 Controller buttons down until you reach the mini mum value 20 then press down one more time 3 00p 2 11 To enter a HIGH reading press up until you reach Select a recent BG the max
90. ct us between the hours of 8 30am and 6 00pm Eastern Time Monday through Friday at 1 800 591 3455 from outside the United States 781 457 5098 We will respond immediately whenever possible some issues may take up to 14 days to resolve 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 affili ation 3 Expect confidentiality of all information pertaining to you your medical care and service Please review our HIPAA Pri vacy Notice later in this section 4 Receive a timely response to your request for service 5 Receive continued service 153 Appendices Select the medical equipment supplier of your choice Make informed decisions regarding your care planning Understand what services will be provided to you YO 0 NO Obtain an explanation of charges including policy for pay ment 10 Agree to or refuse any part of the plan of service or plan of care 11 Voice complaints without fear of termination of service or other reprisals 12 Have your communication needs met You have the responsibility to 1 Ask questions about any part of the plan of service or plan of care that you do not understand Use the equipment for the purpose for which it was pre scribed following instructions provided for u
91. d 68 Bolus basal calcs Menu 6 61 bright Mode e cece eee 5 71 buttons Home POWEFL cc eee e cence 5 Up Down Controller 5 User Info Support 065 5 C CONE aa aL E A 164 cancel DOIUS saata aae ee 36 DOIUS PrE SE bannerin ne 39 one time temporary basal rate 24 temporary basal presets 26 CANMUN A ka d sisarsis oh oevied Saaatnd alae 2 164 automated insertion 7 52 carb preset change category 00ee 41 EKE EEEE TEEI ES E E EE 39 delete EEE EEEE AE 41 Se i E EE ETET 41 fCNAMC sen geeeecletiatesdesiaad 41 carb presets 006 3 39 41 164 carbohydrate 0eeeees 1 164 COUIMING seas era ee 3 164 MISTO aE eames ewes 102 carbohydrate bolus See meal bolus care and maintenance 136 cellular PHONES ccc eee eee 120 change basal prograMms eeeees 21 basal SettingS cce eens 61 bolus presets cce cece eens 39 170 bolus settings ce eee 61 Carb presets ccc cece cee ees 40 temporary basal presets 27 user information 66 104 CHECKAIANNS U aks ewecasteebenes 72 check blood glucose 76 96 CICANING eere aaraa 136 clock 12 hour or 24 hour sessen 61 code number test strip vial 81 87 communication distance to Pod 74 146 interruption 0c e
92. d exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal perfor mance is observed additional measures may be necessary such as reorienting or relocating the equipment 151 Appendices You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi cations equipment transmitters and the OmniPod System as recommended below according to the maximum output power of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter in meters of transmitter in watts 80 MHz to 800 MHz d 0 35 vP 800 MHzto 2 5 GHz d 0 7 vE D 0070 a1 022 i 07 i 221 0 70 For transmitters rated at a maximum output power not listed above the recommended separation distances 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 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 152 Appendices Customer Bill of Rights Mission Statement Insulet Corporation is dedicated to designing developing and
93. e Shakiness e Fatigue e Unexplained sweating Cold clammy skin Weakness Blurred vision or a headache Sudden hunger e Rapid heart rate e Confusion Tingling in the lips or tongue e Anxiety 110 To avoid hypoglycemia low blood glucose Make sure your blood glucose is at least 100 mg dL before driving or working with dangerous machinery or equipment Hypoglycemia may cause you to lose control of a car or dangerous equipment Also when you focus intently on a task you may miss the symp toms of hypoglycemia e Work with your healthcare provider to establish individual ized blood glucose targets and guidelines e Keep a fast acting carbohydrate with you at all times to respond quickly to low blood glucose Examples of fast acting carbs are glucose tablets hard candies or juice e Teach your friends family members and colleagues to recognize the signs of hypoglycemia so they can help if you develop hypoglycemia unawareness or a severe adverse reaction e Keep a glucagon injection kit with your emergency supplies Teach friends and family members how to give a glucagon injection in case you have severe hypoglycemia and become unconscious NOTE Periodically check the expiration date of your glucagon kit to make sure it has not expired Living with Diabetes 9 Always carry medical identification emergency wallet card and wear an emergency medical neck lace or bracelet such as the Med
94. e cence cence 59 POM SEIMO S oee er aa sh mae Te erate eaten teat N 59 The System Setup Menu cece cece eee ee ee eeeees 60 Reset the Date or TIME 6 cece cece eee ence eens 60 RESCUING TING iad baru sins adearenadvadcebuidetaeiedesandess des 60 RESCUING Cale xa se eu tacduskletbewalisi te bisueduabesapadalvstas 61 Change Bolus and Basal SettingS ceceeeeeees 61 BOlUS Cal a inant caine atopiddaakanteaawhess mouanamiaes 62 Ratios factors targets c ccc cccceeeeeceeeeeeeeeeeeeees 64 TEMP Dasal erraien r rE E 65 aS Nla E a ME E E E O T 65 BOLUS INCEMEN regisora N NE 65 WaXDOLUSi eeraa T E E 65 Wax DaSali Fate serron a a S 65 Alerts and Reminders ccc cece cece aa a 66 Set alerts and reMiNders cece cece eee eeeeceeeeeeees 67 Change Blood Glucose Meter SettingS 006 69 Change BG goal limits cece cece eee eeeeeeeeeeees 69 Manage the Blood Glucose Tags List cceeeeeees 70 Change BG SOUNG reerd EE 70 Customize the Personal Diabetes Manager 71 set PDM ODON S aided seats tess coin a a 71 Set Diagnostic FUNCTIONS 0c cece cece e een ee eeeee 72 Diagnostic OPTIONS osaccch cecnast akin erenr yee actenenatiees 73 Get the Most from Your PDM cccceceeeeeeeeees 74 KECD IPN ANGY lt cienncotcocad eeakerd TN A S 74 Communicating with the Pod cccceeeceeeeeeees 74 Water and your PDM 0ccccce
95. e general standard for electromagnetic compatibility IEC 60601 1 2 149 Appendices This equipment is intended for use in the electromagnetic environment specified below The user of this equipment should assure that is used in such an environment Emissions Compliance according to Electromagnetic environment RF Emissions CISPR 11 Group 2 The Pod and the PDM emit low level electromagnetic energy RF in order to communicate Although unlikely nearby electronic equip ment may be affected CISPR B Class B The OmniPod System is suitable for use in all establishments includ Emissions Classification ing domestic establishments The OmniPod System is intended for use in the electromagnetic environment specified below You should observe these require ments in the use of the OmniPod System IEC 60601 1 2 Compliance level Immunity against test level of this device Electromagnetic environment ElectroStatic Discharge contact discharge 8 kV If floors are covered with synthetic material try to avoid electro ESD IEC 61000 4 2 6kV 15kV Static discharges air discharge 8 kV Power Frequency mag 3 A m 400 A m Suitable for most environments Magnetic field strengths in netic fields 50 60 Hz excess of 400 A m would be unlikely except in close proximity IEC 61000 4 8 to industrial magnetic devices 150 Appendices Conducted RF 3 Vrms 3 V m Portable and mobile RF communications equipment should IEC 61
96. e grams of carbohydrate carbs for short you are about to eat Normal bolus When you need a dose of insulin right away to cover a meal or snack you are about to eat or to reduce a high blood glucose level Extended bolus When you are eating high fat or high protein foods which take longer to digest and are slower to affect blood glucose or when you are eating for an extended period for example at a party or during a holiday meal While an extended bolus is active you cannot deliver another extended bolus However you can deliver a normal bolus while an extended bolus is active NOTE The bolus features in the OmniPod System are designed for flexibility and convenience You can easily transition from anormal to an extended bolus with just a few button presses Suggested Bolus Calculator The suggested bolus calculator lets the OmniPod System recom mend your bolus based on your personal settings To review or adjust these settings including turning the suggested bolus calculator On or Off see Chapter 6 Using the Personal Diabe tes Manager If the suggested bolus calculator is turned On the System automatically calculates a bolus dose If the suggested bolus calculator is turned Off you must enter a bolus amount manually CAUTION The suggested bolus calculator will display a sug W gested bolus dose based on the settings you have programmed into the PDM Check with your health care provider before using this f
97. ease button then put down the lancing device 87 7 Checking Your Blood Glucose Lance your forearm upper arm hand thigh or calf 1 To bring fresh blood to the surface of the test site rub the site vigorously for a few seconds Figure 7 23 until you feel it get ting warm a 2 Set the depth setting on the lancing device to 2 Figure 7 24 3 Hold the lancing device with the clear cap against the top of your test site 4 Depress the release button Do not lift up the lancing device instead continue to hold it and gradually increase pressure for several seconds Figure 7 25 5 While holding the lancing device on your test site look through the clear cap The blood sample should be about the size of a pinhead 6 Lift the lancing device straight up be careful not to smear the blood sample on your test site Checking Your Blood Glucose 7 Avoid lancing areas with obvious veins or moles 2 Bring the strip to the blood sample at a slight angle to avoid excess bleeding Also avoid lancing Figure 7 27 areas where tendons or bones stick out for If you do not apply the sample within 10 seconds the strip example hand bones and ankle bones port light turns off To turn it on again press Light Use only one edge of the blood glucose test strip per test Do Fill the blood glucose test strip with blood not
98. eature or adjusting these settings How a suggested bolus is calculated The suggested bolus calculator estimates the suggested amount for each bolus portion based on your personal settings and inputs 30 Understanding and Delivering Bolus Doses 4 The settings used to calculate a suggested bolus are e target BG _insulin to carbohydrate IC ratio e correction factor CF e duration of insulin action The inputs used to calculate a suggested bolus are e current BG e carbs entered insulin on board IOB A suggested bolus can have a correction bolus only a meal bolus only or both Correction bolus The correction bolus as the name suggests corrects for a blood glucose BG level above your target BG level Meal bolus The meal bolus provides insulin for the carbohy drates you enter into the System Insulin on board IOB IOB is the amount of insulin still working in your body from previous correction boluses The amount of time insulin remains on board or active depends on what you set for your duration of insulin action note The OmniPod System can only subtract insulin on board io from a suggested bolus when the current BG is known For formulas for each element of the suggested bolus calcula tion detailed examples and additional guidelines of how the suggested bolus calculator works see the Appendices Deliver a Normal Bolus Deliver a bolus when suggested bolus calcula
99. ed only when your BG is above the value shown in brackets on the screen To save the target BG value press Done To change these set tings select the segment you wish to change and press Edit You can define up to 4 target BG time segments To enter additional segments choose add new then a Press New b Enter a start time for the target BG segment then press Enter c Enter an end time for the target BG segment then press Next d Enter a target blood glucose value then press Next 4 5 e Use the Up Down Controller buttons to enter the cor rect above value or correction threshold the BG value above which you want the PDM to suggest a correction bolus then press Next f When you have finished entering segments press Done To see the segments as a list press List To return to the graphic view press Graph Press Save to accept the target BG profile you have set Enter minimum BG allowed for use in bolus calculation 1 2 Use the Up Down Controller buttons to enter a minimum blood glucose value below which the System will not calcu late a suggested bolus The values are in 1 mg dL increments and range from 50 to 70 mg dL Press Next Enter insulin to carbohydrate ratio 1 Use the Up Down Controller buttons to enter your insulin to carbohydrate ratio then press Next Insulin to carbohy drate ratio is the number of carbs covered by 1 unit of insulin 2 Getting
100. ee 75 129 communication failure 129 135 bolus cancellation 133 hazard alarm c eee eee 135 Pod activation 0008 129 Pod deactivation 04 131 Pod operation e eens 129 request for statuS 8 132 complications diabetes related 1 164 confidence alerts ce cee 67 contact information 103 continuous subcutaneous insulin MUSOMA 164 control SOIUtION ccc eee ee eee es 78 OXDIATON oc sssdsde an a e 78 LESU enia a 78 E E dusaene 80 83 copy basal program sssessssssss 22 correct above value See correction threshold correction bolus 31 140 164 correction factor 14 29 63 65 164 correction threshold 29 62 64 164 create basal program eeee eee 18 DOIUS DhESCbissdahciudarncsacasulelss 37 Cal Dreset eeoa EET 39 temporary basal presets 25 CSi merer See continuous subcutaneous insulin infusion COTS CAINS eene es T AA 120 custom alerts cece eee eee 67 68 Customer Care TAX NUMO Eeen xi phone number 006 ix XI WED SiE erii eaaa 16 customize PDM 0cece eee 71 D date and time 000 11 60 dawn phenomenon 08 164 deactivation See Pod deactivating Pod removal dehydration c cece cece eeeee 96 delete basal program eceeeees 23 bolus pres
101. eeeeececeeeeeeeeneees 74 Avoid extreme temperatures cece cece eee ceeneeees 75 Electrical INTEMeENCE lt p2osc20g dances a a a 75 Checking Your Blood Glucose ssessoessocsoeso 76 The Built in FreeStyle Blood Glucose Meter 76 The FreeStyle Blood Glucose Test Strips 0 77 Important test strip information c cece cece eee ees 77 The FreeStyle Control Solution ce cece eee eeees 78 When to perform a control solution test 0006 78 Check that the meter and test strips are working 78 Control solution expiration date c cece eee ee ee ees 78 Ensure accurate control solution results 00eeee 78 Out of range control solution results c cece eee 79 Performing a Control Solution Test 0cee eens 80 Performing a Blood Glucose Test ccc cece cece eees 83 Prepare the lancing GeVICE cece cee eee e eee eeeeees 84 Insert the blood glucose test Strip cece eee e eee ees 85 Set the blood glucose test strip COd cece eee eee eee 86 Lance yOUur fINGEr ccc cece e cece ete cece eee e e 87 Lance your forearm upper arm hand thigh or calf 88 Fill the blood glucose test strip with blood 89 Wait for the reading cc cece ce ceeeeeeeeeeeeeeeeeenes 90 Remove the lancet cceeecccceeeeeceeeeeeeeeeeneees 91 Blood Gluco
102. entry sT 300p 2 11 b To add a segment choose add new then press New Insulin to carb IC ratio Use the Up Down Controller buttons to choose a start Segment gcarb U time end time and correction factor Press Next after 2 each entry 200 1200 5 c When you have completed all time segments press Done then Save 5 Reverse correction Choose On or Off then press Next 6 Insulin action duration Use the Up Down Controller buttons to choose a duration of insulin action then press Done Back Edit Done 7 Press OK b To add a segment choose add new then press New Use the Up Down Controller buttons to choose a start time end time and IC ratio Press Next after each entry 63 6 Using the Personal Diabetes Manager Ratios factors targets When the suggested bolus calculator is turned On you can view and change all the settings using the Ratios factors targets menu option Choose Review all settings then press Select Figure 6 7a Or choose one setting from the menu then press Select Figure 6 7b The steps are the same whether you choose all settings or individual ones note When the suggested bolus calculator is turned Off the i Ratios factors targets option does not appear in the Bolus basal calcs menu Review all settings Target BG Mlin BG for calcs 70 mg dL IC ratio Correction factor Reverse correction On Insulin action 3 5 hr or 300p 2 11 Re
103. ents even though you may have pro The amount shown after cancellation may be in 0 05 grammed the bolus increment to be in 0 10 units Press the Up Down Controller buttons for different dates Press Event to use the Up Down Controller buttons to scroll through the list of information on the screen Press Day to return to dates 99 8 Understanding Your Records Blood Glucose Records The PDM stores blood glucose records for the past 90 days You i 100p 2 11 in 1 00p 2 11 can choose to view individual readings single day trends with 1 day n 7 today BG today individual readings or trends for the previous 7 14 30 60 or 90 4 54p 134 mg dl days Avg BG 114 mg dL 3 54p 90 mg dl Min max 72 166 mg dL 2 54p 99 mg dl View single day trends 1 54p 124 mg dl 1 On the Home screen use the Up Down Controller buttons BG goal 80 150 mg dL ee i ien to choose My records then press Select Within goal 71 EEEN Above goal 14 2 Choose BG history then press Select Below goal 14 The PDM displays the current day trends first Figure 8 5 including Back Trends List e Number of days and number of blood glucose readings n e Average blood glucose Avg BG e Lowest and highest blood glucose Min max e The BGgoal you have set 3 Press List to see a list of the current day s readings e Percentage of readings within the BG goal Figure 8 6 e Percentage of readings above the BG goal e Percentage of readin
104. epare for Emergencies cece cece eee eee cece eees 107 Water and Your Pod ccc cece cece cece eeeeeeeeeees 107 Traveling and Vacationing cce cee ce cece eee ees 108 Plan for changing time ZONES cece cece eee eeeeeees 108 Take enough supplies cece ccc eee e ce eeeeeeeeeeeees 108 Minimize airport security delayS ccc cece eee eeee 109 vi Keep supplies accessible cece cece cee eee eeeeeenes 109 Avoid Lows Highs and DKA ccecececeeeeeee 110 General DIECAUTIONS 43 635 cveduncovdiwaeentatiateanataaereieus 110 Hypoglycemia low blood glucose cceeeeeees 110 Hyperglycemia high blood glucose eeeeees 114 Diabetic ketoacidosis DKA ccccceeeeeeceeeeeees 118 Handling Special Situations cece cece eee eee es 119 SICK AVS age ous e hoon ous ciesedeiaaianauauiadmad saan R 119 Exercising playing sports or working hard 119 X rays MRIs ANd CT SCANS ccc cceee eee eeeeeeeeeeeeees 120 Surgery or hospitalization cceeeeeceeeeeeeeeenes 120 10 Errors Advisories and Hazard Alarms 121 Salley CNE K onora aaa nama reaxdos 121 Blood Glucose Meter Error Message S eeeeeees 121 AGMISONY Alaris cece cass wh sana tueauae de smteh ee venee 124 Hazard Alar S oes tic sisrach vec A paca namie 126 11 Communication Failures ececceccccccccvecs 129
105. er if communication does not work the PDM will walk page you through the necessary steps to re establish communication 1 Move the PDM closer to the Pod The PDM will try to commu Communication can fail ifthe PDM is nicate with the Pod again If communication still fails you will Too far from the Pod It must be within 24 61 cm when a Sa dt ENEKE AIE you are entering or changing settings e Interrupted by outside interference See the OmniPod System Federal Communications Commission FCC Notice Concerning Interference in the Appendices 129 11 Communication Failures A 3 00p 2 11 Communication error C D Move PDM close to pod A 3 00p 2 11 Communication error Move to a new area and then press Retry Retry 2 Move across the room or to a different room Then press Retry a 130 Ifyou press Retry within 2 minutes the PDM tries to communicate with the Pod again If it cannot communi cate it displays the same screen as in Figure 11 2 then finally the Communication timeout screen Figure 11 3 Press OK to check the Pod status A 3 00p 2 11 Communication timeout Press Ok to check pod status OK A 3 00p 2 11 Communication timeout Press Ok to check pod status or press Discard to deactivate pod Discard OK b Ifthe status check fails you will see Figure 11 4 Press OK to try che
106. es 142 OmniPod System Options and Settings 64 143 Pod Specifications ices hsiaivccwods chdantadaabierdoeetdsweesd 144 Accuracy Test Results ccc cece eee eeeeceeneneeenes 145 Flow rate from Startup ccc ccc cece cece eee eeeeeceeeeees 145 FIOW Tate CNOT i555 season ones a E E cue weea sae siaals 145 Personal Diabetes Manager Specifications 146 vil Blood Glucose Meter Specifications ce cece ees 146 OmniPod System Label Symbols 0ceceeees 147 Personal Diabetes Manager ICONS 0ccceeeeeees 147 OmniPod System Federal Communications Commission FCC Notice Concerning Interference 148 Electromagnetic Compatibility cc eee eee ee 149 Customer Bill of Rights 324 o4 ciisada neletaceatain s cee wdekods 153 MISSION Statement weceed eteeuiete coercniedn tees ee tees 153 SCOPE OL SENICE S oi A EE 153 COMPAN aeos ee a Ml AAN 153 SUPDIY SNIDMEN tee eren TEA IRAN 153 MANES aaa Se cea era tarot E a es E N AAS 153 Customer s Bill of Rights and Responsibilities 153 Limited Warranty for the Personal Diabetes Manager 155 HIPAA Privacy Notice ccccceceeceeeeceeenects 156 Uses and Disclosures of Medical Information 156 YOUIRIGMIUS orere naonana cicetatunt cule a a 159 Qur DUNES ca waase sence hades E eclecaswnatueneec 161 What To Do If You Have a Problem or Question 161 Helpful RESOU E
107. esets to use on occasions when you need to adjust your basal rate for a short period of time See Temporary Basal Rates and Presets later in this chapter Create a basal program The Personal Diabetes Manager can store up to 7 different basal programs Each program can contain 24 rates programmed in half hour increments Once you enter a basal program into the PDM you only need to press a few buttons to pick the program you want The Pod continues to deliver insulin at those rates until you change that program or switch to another one note Check with your healthcare provider before adjusting these settings Onthe Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Basal programs Figure 3 1 then press Select pt 300p 2 11 aT 3 00p 2 11 Basal programs Presets gt System setup gt Back Select Basal programs basal 1 add new Back New Choose add new Figure 3 2 then press New 4 Touse the default naming system simply press Next The default naming system automatically assigns program names in numerical order such as basal 1 basal 2 basal 3 If you want to give a different name to the program a Press the Up Down Controller buttons to scroll through the list of characters An up and down arrow symbol on the screen indicates the character you are changing 18 Understanding and Adjusting Basal Rates 3
108. est strip from the vial imme diately replace the vial cap and close it tightly e Withclean dry hands you can gently touch the test strip any where when removing it from the vial or inserting it into the test strip port Do not bend cut or alter blood glucose tests strips in any way Soa Do not use strips beyond the expiration date printed NY onthe package as this may cause inaccurate results For detailed storage and usage information refer to the package insert in the box containing the test strip vial Keep the test strip vial away from children The cap is a choking hazard The cap or vial contains drying agents that may be harmful if inhaled or swallowed and may cause skin or eye irritation 11 7 Checking Your Blood Glucose The FreeStyle Control Solution The FreeStyle control solution Figure 7 2 is a red liquid that contains a fixed amount of glu cose and has three important uses e Toensure that your meter and test strips are working together properly e Tocheck that you are following the correct testing procedure ERE e To practice testing without having to use your own blood FreeStyle Control Solution When to perform a control solution test You should perform a control solution test e When you first get your OmniPod System before doing a blood glucose test When you open and begin using a new vial of test strips e When you suspect t
109. ets c cece eee es 39 bolus reminder 0 008 68 Carb preset cece cece eee ees 41 temporary basal presets 27 depth settings lancing device 85 diabetes ac Gites edre aaa 165 Diabetes Control and Complications Trial DECT oeren A 165 diabetes emergency kit 107 diabetes mellitus ix 165 diabetic ketoacidosis See DKA diagnostic functions 06 72 171 check alarMsS ceeeeeeees 72 temporary basal presets 26 G FOSCUPDIVicicuientae tener acuteae ot 73 EMET aer E Ea 91 GINCAG ON aaa a 108 DRA ortsa eaa 167 error messages BG meter 121 123 oTe E E E EE EEE ix 165 AVOIGING EE E E EO 118 OXEICISE ere cece cece E 114 119 H SVIMIDLOINS wad cet ee alan bade 118 expiration FPA AOE Scecsitexseccoceraaxteandceetacacte cee 119 PCAUING iiss si yutlecsaneandeanaae 118 control solution 00 78 kaar E fecsace sacs tier 126 128 165 duration of insulin action x 15 31 POO aan R eneeeeeneds 66 shut off manually 00 127 140 141 165 test 9 77 healthcare provider secsiuuseevssoan x 165 E expiration alert cc cece cence 66 hemoglobin Alc HDAC 06 166 edit extended bolus 15 30 34 36 165 high blood glucose See hyperglycemia basal segment or rate 21 Extended option ceeeees 65 HIPAA privacy notice 156 161 bo
110. f 10 20 or 30 seconds Set it at the lowest setting 10 seconds to maximize battery life The default is 20 seconds NOTE Press and hold the Power button to turn the screen back on In some cases if it has been less than 5 minutes since the screen timed out pressing the Power button returns you to the same screen you were using If it has been lon ger than 5 minutes the PDM brings you to the Status screen Backlight time out The backlight is on by default while you are using the PDM The time out setting dims the backlight and causes the screen to dim when you have not used it within the time interval that you set Choose an interval of 5 10 or 20 sec onds Set at the lowest setting 5 seconds to maximize battery life The default is 10 seconds For extra brightness on the PDM screen press and hold the User Info Support button for 2 seconds This enables a bright mode The screen will remain in this mode until the PDM times out or you turn it off To preserve battery life use this feature only when necessary Set PDM options 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose System setup then press Select 3 Choose PDM options Figure 6 12 then press Select Date time Bolus basal calcs Alerts reminders BG meter PDM options Diagnostics Yi iv vw Y Y Back Select 71 6 Using the Personal Diabetes Manager 4 Choose o
111. for ketones reading but have no symp toms of high blood glucose retest with a new strip If you still get a HIGH Check for ketones reading follow your healthcare pro vider s recommendation to treat hyperglycemia NOTE You can add and edit tags for LOW and HIGH BG readings just as you would to any other reading To add tags see page 91 to edit tags see page 93 95 7 Checking Your Blood Glucose Important Health Related Information y_N WARNINGS Severe dehydration and excessive water loss may cause false low results If you believe you are suffering from severe dehy dration consult your healthcare provider immediately Test results below 70 mg dL mean low blood glucose hypo glycemia Test results greater than 250 mg dL mean high blood glucose hyperglycemia If you get results below 70 mg dL or above 250 mg dL but do not have symptoms of hypoglycemia or hyperglycemia see Chapter 9 Living with Diabetes repeat the test If you have symptoms or continue to get results that fall below 70 mg dL or above 250 mg dL follow the treatment advice of your healthcare provider If you are experiencing symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide call your healthcare provider immediately Blood circulation is different between the finger or palm at the base of the thumb and other test sites like the forearm upper
112. formation used for this suggested bolus Press Close to return to the Suggested Bolus screen then press Enter NOTE NOTE If the reverse correction feature is turned On and if your blood glucose level is below your target the System subtracts a correction amount from the meal portion of the bolus If the reverse correction setting is turned Off the System does not subtract anything for a blood glu cose level below your target 33 4 Understanding and Delivering Bolus Doses 5 Ifyou have set the blood glucose reminder option to On and you want to add a reminder a Press Yes b Enter the time for the reminder then press OK Press Confirm to begin the bolus delivery Deliver a bolus manually suggested bolus calc is Off 1 On the Home screen use the Up Down Controller buttons to choose Bolus then press Select Enter the number of units you want to deliver then press Enter If the blood glucose reminders feature is turned On you can now set a blood glucose reminder Press Confirm to begin the bolus delivery note As a safety feature the OmniPod System only allows a you to give a bolus at or below the maximum bolus dose you have set See Chapter 6 Using the Personal Diabetes Manager for information on resetting your maximum bolus dose Consult your healthcare pro vider before changing this setting PDM it can only receive commands from that PDM Once a Pod is activated and communicates
113. g kiana c Press Done issed bolus x 7 Ifyou do not want to mark the test as a control solution test Carb guess l press Next instead of Tag Basal evaluation start Basal evaluation stop nore Ifthe suggested bolus calculator feature is turned Off Skipped meal the Bolus soft key appears instead of Next OK Select note Ifyou marka test as a control solution test by mistake you can unmark it Press Tag select Control then Do not apply control solution to both edges of the test strip press Clear If BG sound is set to On the PDM beeps twice The result 8 Compare the control solution test result to the range printed appears on the screen in about 7 seconds on average on the test strip vial label If the result does not fall within the range repeat the test If the result still does not fall within the range call Customer Care 800 591 3455 24 hours 7 days from outside the United States 781 457 5098 82 Checking Your Blood Glucose 7 9 Remove the test strip If the strip port light was turned on it now turns off If you remove the test strip before this step you will still see the available soft keys Cocking handle k Depth settings dial o y Depth indicator window nore Be sure to discard used test strips You can only use test strips once Performing a Blood Glucose Test Figure 7 10 shows the parts of the FreeStyle lancing device Release button
114. get blood glucose levels Incorrect correction factor sensitivity factor Incorrect insulin to carb ratio Prone to severe hypo glycemia Hypoglycemia unawareness Unplanned physical activity Consult healthcare provider about refining these settings as needed Consult healthcare provider about hypoglycemia unawareness and about raising target blood glucose levels If blood glucose is below 100 mg dL eat a snack before activity Consult your healthcare provider about using a temporary temp basal rate 113 9 Living with Diabetes Prolonged or intense exercise Low carbohydrate intake prior to activity Alcohol consumption Adjust insulin delivery as instructed by your healthcare provider Check blood glucose before dur ing 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 pro grams or using a temporary temp basal rate Consume carbohydrate before activity especially if you have not decreased insulin beforehand Check blood glucose before going to bed Consult healthcare provider for guidance Hyperglycemia high blood glucose Insulin Pods use rapid acting insulin so you have no long acting insulin in your body If an occlusion interruption of insulin deliv ery from the Pod occurs your blood glucose can rise rapidly An oc
115. getables fruits and dairy products Carbohydrate counting A method of meal planning based on counting the number of grams of carbohydrate in a given food Carb preset A favorite food item snack or entire meal that can be assigned a custom name and preprogrammed into the PDM You set the carbohydrate value and optionally the fat protein fiber and total calories for each carb preset Complications of diabetes Harmful effects of diabetes such as damage to the eyes kidney heart blood vessels nervous system teeth and gums feet and skin Correction bolus An amount of insulin taken to compensate for high blood glucose levels The OmniPod System calculates the correction bolus by taking the difference between your current blood glucose level and your target blood glucose value then dividing the result by your correction factor Correction factor also known as sensitivity factor A value that indicates how much one unit of insulin will lower your blood glucose For example if your correction factor is 50 one unit of insulin will lower your blood glucose by 50mg dL Correction threshold The blood glucose level above which you would like to take insu lin to reduce an elevated blood glucose CSII continuous subcutaneous insulin infusion Delivering insulin continuously under the skin subcutaneously on a programmed schedule Dawn phenomenon An early morning rise in blood glucose level caused by the n
116. gs below the BG goal Back Event Graph notre LOW and HIGH readings are included in the number of BG readings n but not in calculations or averages 100 In the List view press Event to select individual readings Readings with a question mark icon next to them have addi tional information available Figure 8 7 To see this informa tion use the Up Down Controller buttons to choose the reading Then press the User Info Support button to view details about that reading Figure 8 8 i 11 00p 2 11 i 1800p 2m BG today 7 56p 85 mg dL 3 35p 95 mg dL Z 11 46a 90 mg dL T 7 55a 150 mg dL G Back Day Graph Close BG reading was manually entered BG tag Post meal 4 Press Close to return to the List view 5 Press Graph to see a graph of the data Figure 8 9 Understanding Your Records 8 View multiple day trends 1 2 2 On the Home screen use the Up Down Controller buttons to choose My records then press Select Choose BG history then press Select Press Trends to display blood glucose data for the past 7 days Continue pressing the middle soft key to view trends for the previous 14 30 60 and 90 days The PDM displays the same details for multiple days as for single days plus the average number of BG measurements taken per day Figure 8 10 A 11 00p 2 11 Fy 11 00p 2 11 1 day n 7 today 90 day n 360 TA Avg Read
117. hat your meter or test strips are not work ing properly e When you think your test results are not accurate or if your test results are not consistent with how you feel When you drop or damage your PDM or expose it to liquids e When your healthcare provider advises you to do so Check that the meter and test strips are working A control solution test follows the same procedure as a blood glucose test except that you use a sample of control solution instead of a drop of blood See Performing a Blood Glucose Test later in this chapter When you perform a control solution test if the reading is within the control solution acceptable range the meter is working properly Control solution expiration date FreeStyle control solution is good for 3 months after opening the bottle or until the expiration date printed on the label whichever comes first Count forward 3 months from the date you open a new bottle of control solution This is your discard date Write this date on the side of the control solution bottle For example if you open the control solution on January 15 count forward 3 months to April 15 This is the discard date to record on the bottle and the date to discard it and begin using a new bottle Ensure accurate control solution results e Replace the cap on the control solution bottle immediately after using it 78 Checking Your Blood Glucose 7 Use only FreeStyle control solution with the O
118. here an infusion set or Pod is placed and cannula is inserted Insulin A hormone that helps the body use glucose for energy The beta cells of a healthy pancreas make insulin Insulin on board active insulin The amount of insulin that is still active in the body from a previ ous correction bolus dose The amount of time insulin remains on board or active depends on each individual s duration of insulin action Talk with your healthcare provider to determine your duration of insulin action The OmniPod System continually calculates the IOB to help prevent stacking of correction bolus doses which is a major cause of hypoglycemia Insulin reaction see hypoglycemia Insulin to carbohydrate ratio Number of grams of carbohydrate covered by one unit of insulin For example if your insulin to carbohydrate ratio is 1 15 then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat In vitro Literally in glass Refers to a biological function taking place in a laboratory dish rather than in a living organism 166 Ketoacidosis diabetic ketoacidosis or DKA A very serious condition in which extremely high blood glucose levels and a severe lack of insulin cause the body to break down fat for energy The breakdown of fat releases ketones into the blood and urine DKA can take hours or days to develop with symptoms that include stomach pain nausea vomiting fruity
119. his entry Meals 9 Press Save to add the preset to the category Change or edit a carb preset 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select ee EEE 2 Choose Presets then press Select Back Next Back Select 3 Choose Carb presets then press Select d Press Next 4 Choose the category of the preset you want to change then press Select Figure 4 14 40 Understanding and Delivering Bolus Doses 4 To change the category for a carb preset 1 Choose the carb preset you want to move to another cate gory then press Tag Figure 4 15 300p 2 11 Favorites Blue Yogurt Banana add new Back Tag Edit 2 Choose a new category then press Select To edit a carb preset 1 Choose the carb preset you want to change then press Edit 2 Press Edit again on the next screen 3 Torename the carb preset press the Up Down Controller buttons to enter the characters that spell out the name you want then press Next To erase characters press either Up or Down until you reach the end of the characters which is a blank 4 Enter the grams of carbohydrate in the meal then press Next If you want enter the grams of fiber fat and protein in the meal and the total calories Press Next after each entry not to enter them simply press Next repeatedly to These additional units are not required If you prefer
120. hly dry CATO Never use a blow dryer or hot air to dry the Pod or PDM Extreme heat can damage the electronics 5 Do not put in fresh batteries or attempt to use the PDM until Insert 2 new AAA alkaline batteries into the compartment it has thoroughly air dried 138 Appendices If you drop the PDM The PDM is built to withstand reasonable amounts of abuse but shock or a severe impact can damage it If you drop the PDM or if it is otherwise subjected to severe impact 1 Inspect the outside of the PDM for visible signs of damage 2 Press and hold the Power button to see whether the PDM turns on and whether the LCD screen is damaged 3 Inspect the inside of the battery compartment for visible signs of damage 4 DoNOT use the PDM if it appears damaged or is not working as it should See the warranty coverage on page 155 For 24 hour Customer Care call 800 591 3455 from outside the United States 781 457 5098 Storage and Supplies Storage EEN Wy Store all OmniPod System products and supplies including unopened Pods in a cool dry place Prod ucts or supplies that have been exposed to extreme temperatures may not function properly It is especially important to store your insulin in a well controlled environment Inspect insulin before using it never use insulin that looks cloudy or discolored Insulin that is cloudy or discolored may be old conta minated or inactive Check the insul
121. ht Press the middle soft key labeled Light To turn the light off press Light again Calibration code 27 The code number on the screen should match Light the code number on the side of your test strip vial Figure 7 5 on previous page They must 5 Gently touch only ONE EDGE of the test strip to the control solution Specifically apply the control solution to the test strip edge next to one of the dark colored half circles Figure 7 7 If BG sound is set to On the PDM beeps when the test Strip is full always match or your results will be inaccurate See Set the blood glucose test strip code later in this chapter 4 Wait for the PDM to display Apply a blood sample to the strip on the screen Figure 7 6 If you do not apply the sample within 10 seconds the strip port light turns off To turn it on again press Light 81 7 Checking Your Blood Glucose The Checking screen appears while the sample is process 6 To mark the result as a control solution result rather than a ing Figure 7 8 The strip port light turns off when the sam blood glucose test ple is accepted a Press Tag b Use the Up Down Controller buttons to select Control Figure 7 9 then press Select You can select a second tag rs 300p 2 11 300p 2 11 for the test result in the same way Select BG tag Nore You can select a maximum of 2 tags Control AN Pre meal Checkin
122. hy drate covered by one unit of insulin For example if your insulin to carbohyadrate ratio is 1 15 then you need to deliver one unit of insulin to cover every fifteen grams of carbohydrate you eat Correction or Sensitivity Factor How much one unit of insulin will lower blood glucose For example if your sensitivity factor is 50 one unit of insulin will lower your blood glucose by 50 mg dL Target Blood Glucose Value The blood glucose level you want to achieve For example you may want to keep your blood glu cose close to 100 mg dL Duration of insulin action The length of time that insulin remains active and available in your body after a correction bolus Your individual needs influence the initial settings you and your healthcare provider will enter into the Personal Diabetes Manager PDM during setup see Chapter 2 Getting Started Introduction Your healthcare provider must help you enter these initial set Your Role Safely Using the OmniPod System tings Soon you will enter and change your own settings with ee confidence and ease The OmniPod System is more user friendly Your healthcare provider will give you all the tools and training than most electronic devices you use every day In fact technol you need to be successful with the OmniPod Insulin Manage ogy is what makes the OmniPod System so easy to use ment System However in the end your success depends on YOU You must become actively involved in your own d
123. iabetes management to enjoy the outstanding control freedom and flexibility that is possible with the OmniPod System Your healthcare provider is a valuable resource You will rely on him or her for a lot of critical information about your OmniPod System especially during the first few weeks and months When you have questions about diabetes management after starting Being actively involved means on the OmniPod System do not hesitate to talk with your health e Frequently monitoring blood glucose levels care provider For nonmedical emergencies or for technical questions about your OmniPod System setup or operation you can call Insulet Corporation 24 hours a day 7 days a week at Customer Care 24 hours 7 days 800 591 3455 Learning how to operate your OmniPod System and practic ing proper techniques Visiting your healthcare provider Customer Care Fax 877 467 8538 y with your blood glucose test and you have followed Web site MyOmniPod com all instructions described in this User Guide call your This User Guide is periodically updated Visit MyOmniPod com ne alineale protes sonal to see the most recent version and to find other helpful information Z Do NOT attempt to use the OmniPod Insulin NT 7 Management System before you receive training from your healthcare provider Inadequate training could put your health and safety at risk Xi Introduction About This User Guide C
124. ic Alert tag See the end of the Appendicesfor address telephone and web site information for obtaining these items Again frequent blood glucose checks are the key to avoiding potential problems Detecting low blood glucose early lets you treat it before it becomes a problem Check with your healthcare provider for guidance in any and all areas listed above To treat hypoglycemia low blood glucose Any time your blood glucose is low treat it immediately Check it every 15 minutes while you are treating to make sure you don t overtreat the condition and cause blood glucose levels to rise too high S Even if you cannot check your blood glucose do NOT NY wait to treat symptoms of hypoglycemia especially if you are alone Waiting to treat symptoms could lead to severe hypoglycemia which can quickly lead to shock coma or death 111 9 Living with Diabetes 1 If blood glucose is below 70 mg dL eat or drink 15 grams of fast acting carbohydrate such as glucose tablets juice or hard candy see How much is 15 grams of carbohydrate below Do NOT use chocolate or candy bars to treat low blood glucose Their fat content slows down glucose absorption 2 Check blood glucose again after 15 minutes 3 If blood glucose remains low take another 15 grams of carbohydrate Contact your healthcare provider as needed for guidance 4 Repeat steps 2 and 3 until blood glucose is within the BG goal
125. ies Change batteries soon OK nore When your PDM alerts you that battery power is getting low the PDM will maximize remaining battery life by Disabling bright mode e Disabling the test strip port light Once the batteries are replaced these functions resume 137 Appendices If the batteries run out data in the memory is at risk note The diagram inside the compartment shows you DO NOT remove the old batteries until you have which direction to insert the batteries new ones at hand The longer the batteries are removed the more the memory is at risk 3 Replace the battery door 4 Turn the PDM face up The PDM powers on automatically To replace batteries The PDM is now ready to use Dispose of the old batteries in 1 Open the battery compartment on the back of the PDM by accordance with local waste disposal regulations pushing the compartment latch inward and then upward Figure A 2 No special tools are necessary If the PDM becomes submerged in water The PDM is not waterproof Do not place it in water or leave it near water where it can accidentally fall in If it becomes sub merged in water 1 Dry the outside of the PDM with a clean lint free cloth 2 Open the battery compartment remove the batteries and discard them 3 Use a clean lint free cloth to gently absorb any water in the battery compartment 4 Leave the battery compartment door open until the PDM is thoroug
126. if you have questions about requesting an accounting of the disclosures of your Medical Information 160 Appendices 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 privacy practices with respect to Medical Information Revisions and Modifications We may change our HIPAA Privacy Notice at any time Before we make a significant change in our policies we will change this HIPAA Privacy Notice and post our new notice the Revised HIPAA Privacy Notice We are required to abide by the terms of this HIPAA Privacy Notice until a Revised HIPAA Privacy Notice becomes effective The Revised HIPAA Privacy Notice will be effective for all Medical Information that we maintain as of the effective date of the Revised HIPAA Privacy Notice even if we collected or received the Medical Information prior to the effective date of the Revised HIPAA Privacy Notice The current HIPAA Privacy Notice is posted on our Web sites at Insulet com MyOmniPod com You can also request a hard copy of the HIPAA Privacy Notice at any time by contacting our Privacy Officer What To Do If You Have a Problem or Question If you have any questions relating to this HIPAA Privacy Notice or if you have a problem or complaint please contact us by writing to Insulet Corporation Attn Privacy Officer 9 Oak Park Drive Bedford MA 01730 or by e mailing us at
127. ight These values are used by the suggested bolus calculator 12 00 AM to to to to Suggest correction when BG is above mg dL mg dL mg dL mg dL Name 12 00 AM to to to to to to Insulin to carbohydrate ratio for each time segment defined starting at midnight 12 00 AM to to to to 1 unit of insulin covers g carb g carb g carb g carb My PDM Settings Time that insulin will remain active in the body from a previous correction bolus Correction factor for each time segment defined 1 unit of insulin starting at midnight decreases BG by 12 00 AM to mg dL to mg dL to mg dL mg dL Grams of carbohydrate g carb Rate circle g carb measurement g carb U hr or g carb U hr or g carb U hr or g carb U hr or g carb U hr or g carb U hr or g carb U hr or g carb ZN OmniPod So Insulin Management System Insulet Corporation 9 Oak Park Drive Bedford MA 01730 USA 800 591 3455 781 457 5098 MyOmniPod com 2009 Insulet Corporation All rights reserved Printed in USA FreeStyle is a registered trademark of Abbott Laboratories Windows is a registered trademark of Microsoft Corporation PDM imagery is for illustrative purposes only PDM screens may vary based on model or user settings Model UST200 13705 AW Rev B No strings attached
128. ilures 11 135 Appendices note The OmniPod Insulin Management System has no user serviceable parts If you require assistance operating or maintaining the System please contact Customer Care at 800 591 3455 from outside the United States 781 457 5098 Pod Care and Maintenance Storage Store unopened Pods in a cool dry place Extreme heat or cold can damage Pods and cause them to malfunction If Pods are exposed to extreme temperatures inspect them carefully before use Pods are sterile unless packaging is opened or damaged Do not apply or use a Pod if its sterile packaging is opened or damaged Cleaning Pods are watertight If you need to clean a Pod you can gently wash it with a clean damp cloth Or you can use mild soap and water However do not use strong detergents or solvents They can damage the Pod s casing or irritate the infusion site Hold the Pod securely and take care while cleaning it so the cannula doesn t kink and the Pod doesn t become detached from your skin Personal Diabetes Manager Care and Maintenance Storage When you are not actively using the Personal Diabetes Manager PDM to enter or change programs you can store it in a conve nient nearby location The storage location should be cool and dry RTI Do not store or leave the PDM where it may be W exposed to extreme temperatures such as inside a car Extreme heat or cold can cause the device to malfunction
129. imum bolus you can give at one time then press Next nore The maximum bolus default is 10 units Check with your healthcare provider before adjusting these settings No Yes Set extended bolus doses e Press Yes if you are ready to activate a new Pod See Chap 1 To set the units for an extended bolus dose choose for per tera ae the Pod to learn how EEAO poe cent of the total bolus or choose Units for units of insulin To Press No if you do not want to activate a Pod at this time turn off the extended bolus feature choose Off Then press The PDM displays the Home screen Next 2 Getting Started NOTE You can press and hold the Power button to turn off the PDM at any time during setup Otherwise it turns off automatically after 5 minutes If you do not complete the entire setup within 60 minutes when you turn on the PDM again you will return to the beginning of the Setup Wizard Your healthcare provider will help you fill and apply your first Pod The process is easy because on screen messages walk you through every step Please refer to Chapter 5 Using the Pod for detailed instructions i You may want to adjust the PDM screen time out and backlight time out For more information on how to do this see Chapter 6 Using the Personal Diabetes Manager Use the form at the end of this User Guide to write down all your settings from the Setup Wizard You can also attach a copy of the pum
130. imum value 500 then press up one more time today oO 2 58p 97 mg dL 4 Press Tag to assign a tag to the reading Press OK when fin 2 5 1p 95 mg dL ished For an explanation of entering tags see page 91 5 Press Save to save the reading Or press Cancel to return to the More actions menu without saving the reading Done Tag Or press Done to return to the More actions menu 93 7 Checking Your Blood Glucose 4 Use the Up Down Controller buttons to choose the first tag you want then press Select Figure 7 36 A diamond icon appears next to selected tags as in Pre meal in the figure You can select up to two tags for each BG reading To remove a selected tag highlight it and press Clear The soft key changes from Select to Clear when you highlight the tag o 3 00p 2 11 Select BG tag Pre meal Post meal Missed bolus Carb guess Basal evaluation start Basal evaluation stop Skipped meal Exercise light OK Select 3 00p 2 11 No BG readings in the past 2 hours 6 Press OK to return to the list of readings If no BG readings have been entered into the PDM within the past 2 hours you will see the screen in Figure 7 37 Press OK to return to the More actions menu To learn how to manage your list of tags and to add custom tags see Manage the Blood Glucose Tags List in Chapter 6 Using the Personal Diabetes Manage
131. in manufacturer s instructions for use and expiration date Ordering supplies You can order all OmniPod System products and supplies directly from Insulet Corporation You can order them by calling 800 591 3455 from outside the United States 781 457 5098 Monday Friday 8 30am 8pm Eastern Time We use established reliable carriers to insure fast safe delivery Special or overnight delivery is possible to most parts of the continental United States 139 Appendices Suggested Bolus Calculator Examples A suggested bolus is equal to correction bolus meal bolus insulin on board Examples of each of these elements are shown below Example of correction bolus Target BG 100 mg dL Current BG 200 mg dL Correction factor CF 50 200 mg dL current 100 mg dL target 100 mg dL 100 mg dL 50 CF 2 units correction bolus If the reverse correction feature is turned On and if your current BG is below your target BG the suggested bolus calculator sub tracts a correction amount from the meal bolus Example of reverse correction bolus Target BG 100 mg dL Current BG 75 mg dL Correction factor CF 50 75 mg dL current 100 mg dL target 25 mg dL 25 mg dL 50 CF 0 5 units reverse correction bolus subtracted from meal bolus Meal bolus calculation Carbs entered insulin to carb I C ratio Example of meal bolus Carbs entered 45 grams of carb Insulin to carb ratio 15 45 carbs
132. in the temporary basal rate shown on the screen The Pod beeps to indicate that the chosen tempo rary basal preset is running Cancel an active temporary basal preset 1 On the Home screen use the Up Down Controller buttons to choose Suspend cancel then press Select 2 Choose Cancel temp basal then press Select 3 Press Confirm to cancel the actively running temporary basal preset note Ifyou suspend insulin delivery while a temp basal is i running the temp basal will be cancelled when you resume Change rename or delete a temporary basal preset 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose Presets then press Select 3 Choose Temp basal presets then press Select 4 Choose a temporary preset from the list then press Edit nore You cannot edit change or delete a temporary basal ra preset that is actively running 5 Follow the steps below 26 Understanding and Adjusting Basal Rates 3 To change a temporary basal preset 1 Choose Edit then press Select Figure 3 16 K 3 00p_2 11 Aerobics Rate 0 20 Uhr Duration 2 0hr Edit Rename Delete Done Select 2 Enter a new rate or new percent change for the preset then press Next 3 Enter anew duration for the preset then press Save 4 Press Done To rename a temporary basal preset 1 Choose Rename then press Select 2 Press the Up Down Controller but
133. ing the insulin you need These alerts include Bolus delivery started Bolus delivery completed eta atas Sa oh ae Extended bolus started Expiration 4 hr Extended bolus completed Low reservoir 10 00u Temporary basal rate started Auto off Off Bolus reminders Off Reminder alerts On Confidence alerts On e Temporary basal completed Choose On or Off The default setting is On Custom alerts Displays text reminders that you enter at times Custom alerts that you select You can choose to receive an alert Daily One time only or Off You can change or delete these custom alerts Back T Select at any time 5 For all except Bolus reminders and Custom alerts choose Set alerts and reminders the desired option or set the desired value then press Select 1 On the Home screen use the Up Down Controller buttons or Enter to choose Settings then press Select 2 Choose System setup then press Select 3 Choose Alerts reminders then press Select 67 6 Using the Personal Diabetes Manager 6 For Bolus reminders Use the Up Down Controller buttons to choose On or Off then press Select If you chose On you are taken to a new screen where you can add edit or delete reminders To add a Bolus reminder a Use the Up Down Controller buttons to choose add new then press New b Choose a start time then press Next c Choose an end time then press Save To edit a Bolus reminder a Choo
134. ion such as pain swelling redness discharge or heat If an infusion site shows signs of infection 1 Immediately remove the Pod and apply a new one at a different site see Chapter 5 Using the Pod 2 Contact your healthcare provider 3 Treat the infection according to instructions from your healthcare provider Refer to Chapter 5 Using the Pod for how to prepare and care for a site u Consider making infusion site checks a part of your regular daily routine like showering or brushing your teeth That way it s easy to remember If you observe blood in the cannula check your blood glucose more frequently to ensure insulin delivery has not been affected If you experience unexpected elevated blood glucose levels change your Pod 106 Living with Diabetes 9 Prepare for Emergencies p g Phone numbers for your healthcare provider and or doctor in case of an emergency Keep an emergency kit with you at all times to quickly respond to any diabetes emergency The kit should include Several new sealed Pods Extra new PDM batteries at least two AAA alka Glucagon kit and written instructions for giving an injection if you are unconscious see Avoid Lows Highs and DKA later in this chapter Ask your healthcare provider to help you develop ine o o plans for handling emergency situations including A vial of rapid acting U 100 insulin See the warn what to do if you cannot
135. isplays the date time and grams of carbohydrate you have entered Figure 8 13 on the following page 102 A 11 00p 2 11 A 11 00p 2 11 Carb history today All history today 6 32p 86g 8 52a basal 0 05 u hr E 29 8 50a bolus0 70u cee g 8 50aBG80mg d g 8 50a carb 17 g 8 49a basal temp 0 06 Urhr 420 Back Event Back Event 3 Press the Up Down Controller buttons to see additional days Press Event to use the Up Down Controller buttons to scroll through the list of information on the screen Press Day to use the Up Down Controller for dates All Records The PDM displays the combined insulin delivery blood glucose alarm and carbohydrate records 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select Understanding Your Records 8 2 Choose All history then press Select The PDM displays all history for the most recent date Figure 8 14 3 Press the Up Down Controller buttons to see additional days Press Event to use the Up Down Controller buttons to scroll through the list of information on the screen Press Day to use the Up Down Controller for dates User Information Support You or your healthcare provider may have entered personal contact information during your start up visit To view this infor mation press the User Info Support button to the right of the Power button while on the Home screen Or follow the s
136. ith it to turn off the alarm you can turn it off manually See the end of Chapter 11 Communication Fail ures for instructions 54 Using the Pod 5 Suspend Insulin Delivery 2 Enter how long you want to stop all insulin delivery from 30 eh le minutes to 2 hours in 30 minute increments Figure 5 23 Sometimes you may need to briefly stop insulin delivery for then press Enter example when editing an active basal program or changing the time or date The OmniPod System lets you suspend all insulin delivery for up to 2 hours While in suspension the Pod beeps once every 15 minutes reminding you that insulin delivery is 3 00p 2 11 m 50 U 3 00p 2 11 suspended Suspend insulin delivery LastBG 110 mg dL 9 08a today note At any time during a suspension period press Resume Enter duration Last bolus 1 15u to resume the basal program that was running when you 8 44a today suspended insulin delivery 10h r INSULIN SUSPENDED note Extended boluses and temporary basal rates will be can i celled when you suspend insulin delivery 1 On the Home screen use the Up Down Controller buttons to choose Suspend then press Select Back __ Enter Home NOTE Ifa temporary basal or extended bolus isin process the 3 Press Confirm to confirm that you want to halt all insulin i menu item is Suspend cancel instead and options for delivery basal and bolus The PDM beeps and an on screen canceling
137. k the Pod status or press Discard to begin the deactivation process A 3 00p_ 2 11 Communication timeout Bolus status unknown Press Ok to check pod status or press Discard to deactivate pod Discard OK 4 lf at any point in this process the PDM can communicate again with the Pod you will see Figure 11 15 The message indicates that your original instruction to cancel the bolus was successful a Press OK The PDM displays the screen in Figure 11 16 showing how much insulin was delivered before the bolus was canceled AN 3 00p 2 11 a 300p 2 11 Communication Bolus canceled successful 0 75u delivered OK LOK b Press OK again to return to the Status screen 134 Failure During a Hazard Alarm lf you respond to a hazard alarm see Chapter 10 Errors Adviso ries and Hazard Alarms but the PDM cannot communicate with the Pod to acknowledge or shut off the alarm you can shut off the alarm manually 1 Remove the Pod from your body if you have not already done so 2 Press the end of a paper clip or similar item straight down into the manual alarm shut off port Figure 11 17 on the top side of the Pod Figure 11 18 The port can be found by following the bright white trail on the top of the Pod Move the paper clip back and forth until the alarm stops Then discard the Pod according to local waste disposal regulations Communication Fa
138. lus reminder 000005 68 extreme temperatures 72 history Carb preset s eee ee eeee eee 41 F INS ea EE uk eteie ee 102 electrical interference 75 failure See communication failure Si e cette che cateae es ote it wae 103 electrical safety Sea a ee oe ee 165 ee E cid evince anit rebate 98 electromagnetic compatibility 149 152 FCC NOC is wie oaa a 148 blood glucose ee ee ee ee 100 electromagnetic fields 75 eE EE E T 40 165 bOIUS r eare l 99 emergency Kitsccentheutaois 105 107 108 fill syringe Gane Gita wi arate E EAE 46 48 carbohyd VAL OS scien too dscns tains 102 empty reservoir hazard alarm 127 Flowaccuracy insulin delivery 0 0e00 97 98 enable POG 424i tiidon ands E 145 HOME SCIEN cc cccccccccccccccce 6 7 Dasal Progra sarerea ap 20 Flow rate erfor 145 Home Power button bolus preset eeeee eee 38 foundations 162 _ hospitalization 0 eeeeeee 120 one time temporary basal rate 23 172 hyperglycemia 96 105 114 117 166 AVOIGING eere ese aTe nas 115 CAUSES naa E R ENG 116 SVIMDLOMIS iuran aa 114 ThEATING oo vein hi nn E 115 hypoglycemia 76 96 105 110 114 166 AVOICING signees and daw tees wriausan 111 CAUSES prorina eaa aah 113 SYMPTOMS roa arn ans 76 110 Mea ueria E 111 hypoglycemia unawareness 76 111 166 l CONS esana aOR 147
139. ly may reduce insulin absorption Do NOT apply the Pod within 2 of your navel or over a mole or scar where insulin absorption may be reduced q To help avoid condensation from occurring in the viewing window make sure both your Pod and your insulin are at room temperature z Using the Pod 5 lt Front Back __ 49 5 Using the Pod lt Front Back gt Prepare the infusion site You can reduce the risk of infection at the infusion site by follow ing aseptic technique and disinfecting the infusion site Before applying a new Pod always 1 Wash hands with soap and water 2 Use soap to wash the infusion site nore Antibacterial soap may irritate skin especially at the i infusion site Ask your healthcare provider how to treat any skin irritation 3 Dry the site with a clean towel 4 Usean alcohol prep swab to disinfect the infusion site Start at the center of the site and gently rub outward in a circular motion 5 Let the site air dry thoroughly Do not blow on the site to dry it 50 Using the Pod 5 Apply the new Pod 2 Using the pull tabs remove and discard the white paper Prepare the Pod for applying to your infusion site backing from the adhesive tape Figure 5 16 1 To remove the needle cap on the underside of the Pod pullit 3 Apply the Pod to the prepared infusion site Press firmly to upward Figure 5 15 secure
140. ly orericcder sarnane 23 basal segment 008 12 17 basal SettingS e cece acne 12 batterieS cece eee 10 97 137 BG1AG eee See tag a BG result blood glucose BG QOdllintii ceseuienawnees 12 69 163 BG reminder ce cece eee 66 Checking eeeeees x 76 96 COOG sn A 80 86 MISLORY soc xe eran gata sake ernest 100 E E TE TET 29 163 MONRONING eesairerereaitin xi 2 SOUNO es 0tsing cdtoueGaenasabuws 12 70 test sites 4 u 0i discudsccaciens 76 87 88 test SMD erisin ina e 85 blood glucose meter 2 76 96 163 error messages 121 123 readings cece cece cence eens 3 90 SEMINO S rese 69 specifications sssrin sr beeing 146 blood glucose readings enter manually 00 93 lowand high ceeeees 95 DOUS saone e 1 3 29 31 CNCE sra Aa OSN 36 OSE EEPE EENT 29 163 extended 005 30 34 165 NISLOLY Era 99 manual delivery 0008 34 a101i 1T PERE 30 31 PresetS cc cece ee eeee 37 39 163 ratios factors targets 64 FOMINGELS s 55 acces u escsatons 66 68 SENOS ice sedate a 61 65 suggested bolus calculator 30 34 140 142 bolus presets 008 37 39 163 CANCE nei sauae sh ra ER 39 ECMANGE s scua ore a E airs 39 COAG wraith nando samara aesdiaates 37 a E E e E AE EAE 39 Shale orean EEEN ee 38 eNA nese loess eee EE 39 bolus reminder AOC ahs iets tient eee yada se
141. mmunicable disease or may otherwise be at risk of contracting or spreading the disease or condition Health Oversight We may disclose Medical Information to a health oversight agency for activities authorized by law such as audits investigations and inspections Oversight agencies seeking this information include government agencies that oversee the healthcare system government benefit programs other government regulatory programs and civil rights laws Food and Drug Administration We may disclose your Medical Information to a person or company as directed or required by the Food and Drug Administration i to report adverse events or similar activities with respect to food or dietary supplements product defects or problems including problems with the use or labeling of a product or biological product deviations ii to track FDA regulated products iii to enable product recalls 157 Appendices repairs or replacement or lookback including locating and noti fying individuals who have received products that have been recalled withdrawn or are the subject of lookback or iv to con duct post marketing surveillance Legal Proceedings We may disclose your Medical Information in the course of any judicial or administrative proceeding in response to an order of a court or administrative tribunal to the extent such disclosure is expressly authorized in certain conditions in response to a subpoena discovery re
142. mniPod System Other brands of control solu tion may produce inaccurate results with this System Koa Do not use control solution past the expiration q 7 date or you may get inaccurate results Do not add water or any liquid to control solution e Control solution tests are specified to be accurate only when performed between 59 and 104 F 15 and 40 C SEATON Results from FreeStyle control solution tests do W not reflect your blood glucose level e Thecontrol solution test results should fall within the range printed on the test strip vial label NOTE If control solution results are out of this range REPEAT THE TEST The control solution range is a target range for control solution only It is not a target range for your blood glucose Out of range control solution results Out of range test results may be caused by Expired or bad control solution Expired or bad test strip Error in performing test Watered down control solution Code on test strip vial does not match code set in the PDM e Malfunction of the OmniPod System e Control solution test done outside 59 to 104 F 15 to 40 C If your control solution test results continue to fall outside the range printed on the test strip vial 1 The OmniPod System may not be working properly 2 Donot use the System to test your blood glucose 3 Call Customer Care 800 591 3455 24 hours 7 days from outside the United States 781 457 50
143. n 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 159 Appendices Your request must state the specific restriction requested and to whom you want the restriction to apply We are not required to agree to a restriction that you may request but if we do agree to the requested restriction we may not use or disclose your Medi cal Information in violation of that restriction unless it is needed to provide emergency treatment If you would like to request a restriction of the use of your Medical Information please down load our Request Form at http www myomniPod com images upload HIPAA_Privacy_Notice_Request_Form pdf and follow the directions included on that form We will respond to your request in a reasonable amount of time Please contact our Privacy Officer if you have questions about requesting a restriction of the use of your Medical Information You Have the Right to Request to Receive Confidential Communications from Us by Alternative Means or at an Alternative Location We will accommodate reasonable requests to receive confidential commu
144. n press Enable de 3 00p 2 11 Basal programs basal 1 basal 2 Weekend add new Back Enable Select Understanding and Adjusting Basal Rates 3 c 3 00p 2 11 Weekend View Edit Rename Copy Delete Done Select is active You cannot select the active program to enable it because it is already running A diamond icon appears next to the program that 4 Press Enable again to start the selected basal program If a Pod is active the PDM beeps to indicate that the chosen basal program is running program while a temporary basal preset is in process see Temporary Basal Rates and Presets later in this chapter you must first cancel the active temporary basal preset As a Safety feature you cannot enable a new basal Change rename copy or delete a basal program 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose Basal programs then press Select 3 Choose a program from the list then press Select To view the segments of the basal program 1 Choose View then press Select Figure 3 8 To edit or adda segment or rate in the basal program 1 Choose Edit then press Select note Asa Safety feature you must suspend insulin delivery i before editing an active basal program see Chapter 2 Getting Started Remember to resume delivery after the edits are made 21 3 2 Understanding and
145. n press d Press Next Next d Enter the rate for the new basal segment for example 0 80U hr then press Next 3 Understanding and Adjusting Basal Rates Basal rates outside the changed segment do not change he 3 00p 2 11 i 3 00p 2 11 Press Save to add Press Save to add e Repeat steps a d for each new segment and rate you Weekend to your Weekend to your want then press Done basal program list basal program list 1 00 Segment U hr 12 00a 8 00a 0 60 8 00a 3 00p 0 30 3 00p 12 00a 0 70 back on In some cases if it has been less than 5 minutes since the screen timed out pressing the 0 50 Power button returns you to the same screen you were using If it has been longer than 5 minutes the Press and hold the Power button to turn the screen PDM brings you to the Status screen n ea 1p 6p 12a amp Wis Graph 7 Review the graph of the new basal program Figure 3 5 Sates Goal REE cl sian Lael el 8 Tosee the program as a list press List Figure 3 6 To see the Enable an existing basal program graph again press Graph 1 On the Home screen use the Up Down Controller buttons 9 To add the program to the PDM s memory press Save to choose Settings then press Select Repeat steps 1 through 9 above for each basal program up to 7 2 Choose Basal programs then press Select you want to create l l l 20 3 Choose the program you want from the list Figure 3 7 the
146. n the back of the PDM or used batteries the PDM may not work properly by pushing the compartment latch and lifting upward Figure 2 1 No special tools are necessary 3 Replace the battery door 4 Turn the PDM face up The PDM has begun to power on automatically 2 Insert two 2 new AAA alkaline batteries into the compart ment Getting Started 2 The OmniPod Setup Wizard The first time you turn on the Personal Diabetes Manager the Setup Wizard comes on automatically Although setup is easy with the Wizard if you are a first time user your healthcare pro vider must guide you through the process Setup takes only a few minutes and is easy to do Use the Up Down Controller buttons to increase or decrease a number or to move up or down alist note Initial settings are blank for target blood glucose i value insulin to carbohydrate ratio correction factor and duration of insulin action e Press the soft key labeled Next Select Done or Save to con tinue to the next screen e Press Back to return to the previous screen Nore YOU can adjust these settings later as your needs change or you fine tune your OmniPod System See OmniPod System Options and Settings in the Appendices The Wizard s Welcome screen Figure 2 3 gets you started Press Next to begin setting up your PDM an Welcome to the OmniPod Insulin Management System Press
147. ne of the options Figure 6 13 then press Select or 3 00p 2 11 PDM lock Off Screen time out 20 sec Backlight time out 10 sec Back Select Set PDM lock Choose On or Off then press Select If you choose On other PDM options and most other soft keys are locked and will not respond to button presses To use them you must first set PDM lock to Off Set the Screen time out Choose a time interval of 10 20 or 30 seconds then press Select When the screen times out and goes black turn it on again by pressing the Home Power button Set the Backlight time out Choose a time interval of 5 10 or 20 seconds then press Select When the screen dims turn it on again by pressing any button The PDM will ignore the usual command and relight the screen The lowest setting 5 seconds will drain the battery the least Set Diagnostic Functions The Diagnostics screen allows you to instantly confirm how the System is working or to completely update settings entered dur ing setup see Chapter 2 Getting Started Options include Check alarms Confirms that all alarms work properly when needed When you select this function the PDM beeps then the Pod beeps 72 Using the Personal Diabetes Manager 6 If the PDM fails to beep immediately call Customer Diagnostic options Care at 800 591 3455 from outside the United 1 On the Home screen use the Up Down Controller buttons States 781 457 5098
148. near a scar or mole Infected infusion site Dislodged cannula Deactivate and remove used Pod Apply new Pod filled with insulin from a new vial Deactivate and remove used Pod Apply a new Pod in a different location Deactivate and remove used Pod Apply a new Pod in a different loca tion and consult your healthcare provider Deactivate and remove used Pod Apply a new Pod in a different location note Avoid sites near a waistband belt or other areas where fric tion may dislodge the cannula Empty Pod Incorrect basal program Incorrect bolus timing Bolus too small Deactivate and remove used Pod Apply a new Pod in a different location Confirm that correct basal program is active Confirm that PDM time is set correctly Consult your healthcare provider about adjusting your basal pro grams or using a temporary temp basal rate Check carb intake Take bolus with food Check blood glucose before giving meal bolus if necessary adjust bolus Consult healthcare provider for guidance 116 High protein or high fat meal Less activity than normal Blood glucose value greater than 250 mg dL with ketones present before exercise Infection or illness Medication change Calculate protein fat intake and account for it in your bolus timing and bolus type Consult healthcare provider about using the extended bolus option Consult your healthcare provider ab
149. ner ee eee e ee 168 SNOOK rarr pars aire tus tao et ORR 43 SICK CaYSieidct oeer a LRE 119 soap solvent cece eee eee 74 136 SON KOV Suorsa eeen xii 5 168 soft reset ccc vanwwecicreventa See reset PDM special symbols in record screens 97 specifications BG meter osssnosesuserneserss 146 PON arere eee cevewyoaouesans 146 FOO ereraa nearness 144 SOOMMS cessu E TaT ESNS 119 SEF K erreostatoa 9 Status screen i staat iA iwksGnedeaswias 6 7 Status SCFEENS eee eee ee eee 58 59 storage temperature 144 146 Stuck key advisSOry 0ceeees 125 suggested bolus calculator 3 12 30 34 92 168 OXAMPIES cece eee eee 140 141 guidelines c cece eee 142 supplies OFGELING anaana eaS 139 packing for travel 6 108 SUVOCIY inet on schon r NE 120 suspend insulin delivery 55 symbols in history records 000 97 OSEE tixcnieucs uments eine 147 System labels 0 0085 147 symptoms DORA REEE A IE A E 118 hyperglycemia 008 114 hypoglycemia 76 110 System error hazard alarm 126 128 System options and settings 143 System Setup MENU eee eee ees 60 T tag a BG test result 0 82 tags AIE tar iuiitereceund tances 70 91 target BG 8 29 62 64 168 target blood glucose value 13 temperatures CXILCIMC E E E E 75 ope
150. ng are only general alternate between sugar free beverages and those guidelines containing sugar When you are ill check your blood glucose more often at least once every 2 hours to avoid DKA The symptoms of DKA are Call your healthcare provider immediately if you have much like those of the flu Before assuming you have the flu Persistent nausea check your blood glucose to rule out DKA see Diabetic ketoaci Vomiting for more than 2 hours dosis DKA earlier in this chapter Iing e High blood glucose or ketones that stay high even To handle sick days though you take extra insulin e Treat the underlying illness to promote faster recovery Low blood glucose with nausea and vomiting Eat as normally as you can a e Adjust bolus doses if necessary to match changes in meals Exercising playing sports or working hard and snacks Check your blood glucose levels before during and after exercis acili ing playing sports or doing unusually hard physical labor Always continue your basal insulin even if you are unable to 9 Playing gt P g y pny eat Contact your healthcare provider for suggested basal The Pod s adhesive keeps it securely in place for up to 3 days rate adjustments during sick days However if necessary several products are available to enhance scheck yout Boodglucosseveny 2 hoursand keep cared adhesion Ask your healthcare provider about these products records of results Avoid getting body
151. nications from us by alternate means or at an alternative location We may also limit this accommodation by asking you for information as to how payment will be handled or specification of an alternative address or other method of contact We will not request an explanation from you as to the basis for the request Please make this request in writing to our Privacy Officer You Have the Right to Receive an Accounting of Certain Disclosures We Have Made if any of Your Medical Information This right applies to disclosures for purposes other than treatment payment or healthcare operations as described in this HIPAA Privacy Notice It excludes disclosures we may have made to you for a facility directory to family members or friends involved in your care or for notification purposes You have the right to receive specific information regarding these disclosures that occurred after April 14 2003 or as otherwise provided for under applicable law You may request a shorter time frame The right to receive this information is subject to certain exceptions restrictions and limitations If you would like to request an accounting of certain disclosure of your Medical Information please download our Request Form at http www myomniPod com images upload HIPAA_Privacy_Notice_Request_Form pdf and follow the directions included on that form We will respond to your request in a reasonable amount of time Please contact our Privacy Officer
152. ns 25 Enable an existing temporary basal preset 6 26 Cancel an active temporary basal preset 0008 26 Change rename or delete a temporary basal preset 26 Maximum Basal Rate cccceeceeececeeeeeeeenees 28 What is the maximum basal rate c cece cece eeeees 28 Change the maximum basal rate cece eee ee ees 28 4 Understanding and Delivering Bolus Doses 29 What ls a BOUS 3 240005 Paes ania deuS weed iti ade Tea 29 Bolus DOSE ODTIONS irere irere eu AE TE KEEA 30 Suggested Bolus Calculator ccc cece cence eee eees 30 How a suggested bolus is calculated 00eee eee 30 Deliver a Normal Bolus 0 cece cece cece cece ee eeees 31 Deliver a bolus when suggested bolus calculator is On 31 Deliver a bolus manually suggested bolus calc is Off 34 Deliver an Extended Bolus cc cece cece cece cece 34 Deliver an extended bolus instead of anormal bolus 34 Cancel Active BOIUSES cece cece cece cece eee eeenees 36 BONUS PrO SEE lt asia ponies sare eaten Ga euee or eaues eae 37 Create a bolus preset cece cece cece cece ne een eeeenees 37 Enable an existing bolus preset cceeecceeeeeeeee 38 Change rename or delete a bolus preset 006 38 Cancel an active bolus preset c cece cece ec eeeeeeees 39 CarD PrE SEIS orar ren E ES 39 Create a carb preset
153. ntee faultless operation but should provide reasonable assurance of such This information may not be applicable to other medical electrical equipment older equipment may be particularly sus ceptible 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 Portable and mobile RF communications equipment can affect medical electrical equipment Cables and accessories not specified within the instructions for use are not authorized Using other cables and or accessories may adversely impact safety performance and electromagnetic compatibility increased emission and decreased immunity Care should be taken if the OmniPod System is used adjacent to other electrical equipment if adjacent use is inevitable such as in work environments the OmniPod System should be observed to verify normal operation in this setting The OmniPod System communicates by low level RF energy As with all RF receivers the potential for disturbance exists even with equipment that complies with FCC and CISPR emissions requirements The OmniPod System communicates with the following characteristics Frequency 13 56 Mhz ASK modulation with an effective radiated power of 16mW The OmniPod System greatly exceeds the immunity require ments of th
154. o give a different name to the program a Press the Up Down Controller buttons to scroll through Back Next the list of characters An up and down arrow symbol on i d Press Next the screen indicates the character you are changing 6 Enter the new temporary basal rate or percent change then b Press the middle soft key to move the underscore to the press Next next character 7 Enter the duration of the temporary basal rate from 0 5 hours c Enter each character one at a time For example if you to 12 hours then press Next take an aerobics class two nights a week you might enter l A r o b i s Figure 3 14 on the next page A blank Review the temporary basal name rate and duration then character or space is the first and last option in the scroll press Save to accept it ing menu Capitals and lowercase letters are considered the Co same 25 3 Understanding and Adjusting Basal Rates Enable an existing temporary basal preset 1 2 On the Home screen use the Up Down Controller buttons to choose Temp basal then press Select Choose the temporary basal preset you want to use from the list Figure 3 15 then press Select K 3 00p_ 2 11 Temp basal presets enter manually Aerobics 0 20 U hr 2 0hr Back Select Ifyou want change the duration for the temporary rate in half hour increments then press Enter Press Confirm to beg
155. od expiration advisory Pod 2 sets of beeps that repeat periodically Press OK to acknowledge Change pod now Repeats every 15 minutes during the lasthourof Change Pod see Chapter 5 Using the the Pods life Pod Escalates to Pod expired hazard alarm 124 Errors Advisories and Hazard Alarms 10 End of insulin suspend 2 sets of beeps every minute for 3 minutes Press OK to resume insulin delivery at programmed basal rate Press Ok to resume basal Repeats every 15 minutes until insulin delivery is rate delivery resumed Auto off advisory Pod 2 sets of beeps every minute for 15 minutes Press OK to acknowledge ane Escalates to Auto off hazard alarm if not Reset clock PDM be acknowledged within 15 minutes Stuck key detected PDM 2 sets of beeps every 5 minutes Check the key described on the Check Home button to screen In this example the stuck key resolve is the Home button Press the key to unstick it For technical support call 800 591 3455 If this does not work call Customer Care at 800 591 3455 for assistance from outside the United States 781 457 5098 125 10 Errors Advisories and Hazard Alarms Hazard alarms occur either when the Pod is in a very serious con Hazard Alarms dition or something is wrong with the PDM Hazard alarms are continuous tones and each has an on screen message Follow the instructions in the message to fix the alarm situation For details see the table bel
156. onventions and Terms Soft keys A row of three unlabeled buttons on the PDM whose label or function appears on the screen directly above the button The label changes depending on the task you Bold Names of buttons soft keys menus and are performing screens are in bold Italics Words in italics are defined in the Symbols Glossary at the end of this User Guide Press Press and release a button or soft key TEN Warning Describes potential serious adverse WARNING reactions or indicates conditions that Hold Keep pressing a button until its function is could cause death or serious injury complete T7 Caution Indicates conditions that could cause Alist of ooti the PDM Opti l ue minor or moderate injury to you or Menu ist of options on the Options allow damage to the device you to perform tasks NOTE Note Provides helpful information Screen Displays programming operating and alarm alert information Ply ie ee a gt Tip Offers a suggestion for successful use Button oe are on the PDM such as the TPG of the OmniPod Insulin Management ome Power button System Icon An image on the PDM screen that indi cates a menu option or item of informa tion A table of screen icons appears in the Appendices xii Your New OmniPod Insulin Management System Insulin Delivery with the OmniPod System Continuous insulin delivery at preset rates eliminates the need lt lt lt for injection
157. or example if you want to enter your address you might enter 5 6 5 space M a i n space S t period A blank character or space is the first and last option in the scrolling menu For your healthcare provider and local phone number you might enter J a n e space S m i t h Comma space 5 5 5 hyphen 1 2 3 4 Figure 8 16 Press Save Repeat steps 3 7 for each line of personal information you want to enter or change Twenty lines are available 104 Living with Diabetes Your Role Safely Using the OmniPod System Before deciding on the OmniPod Insulin Management System you and your healthcare provider discussed the advantages and benefits of the OmniPod System as well as the responsibilities that come with insulin pump therapy Remember safe use begins and ends with you If you have questions or doubts about being able to safely use the OmniPod System at any time consult your healthcare provider immediately Most problems are easily avoided by e Learning all you can about successful diabetes management e Being actively involved in your treatment e Checking your blood glucose levels frequently e Washing your hands and disinfecting infusion sites to reduce the possibility of infection Being aware of the signs of hypoglycemia low blood glu cose hyperglycemia high blood glucose and diabetic ketoacidosis DKA See Avoid Lows Highs and DKA later in this chap
158. or more basal rates that together cover a 24 hour period from midnight to midnight Basal rate A small base or background amount of insulin that is delivered at a preset rate continuously for a specified period of time Basal rates are measured in units per hour U hr Basal segment time segment The time period during which a specific basal rate is delivered BG goal A range of blood glucose levels that you are trying to achieve dur ing acertain period of the day For example you may want one BG goal before meals a different BG goal two hours after meals and yet another BG goal for bedtime Blood glucose see glucose Blood glucose level The amount of glucose or sugar in the blood Blood glucose meter A device used to check blood glucose content Bolus dose A dose of insulin taken to correct an elevated blood glucose level or to cover carbohydrates in a meal or snack Bolus preset A bolus dose of insulin in units that can be assigned a custom name and preprogrammed into the PDM 163 Calorie A unit of measurement used to express the energy value of food Calories come from carbohydrate protein fat and alcohol Cannula A small thin tube inserted below the skin which serves to intro duce a liquid medication into the body Carbohydrate carb One of the three main nutrients found in food The other two are protein and fat Foods that contain carbohydrates include starches sugars ve
159. ormal release of hormones that block insulin s effect 164 Diabetes Control and Complications Trial DCCT A study by the National Institute of Diabetes and Digestive and Kidney Diseases NIDDK conducted from 1983 to 1993 in people with type 1 diabetes which showed that good blood glucose control significantly helped prevent or delay diabetes complications Diabetes diabetes mellitus A condition characterized by hyperglycemia high blood glucose resulting from the body s inability to use blood glucose for energy In type 1 diabetes the pancreas no longer makes insulin and therefore blood glucose cannot enter the cells to be used for energy In type 2 diabetes either the pancreas does not make enough insulin or the body is unable to use insulin correctly Diabetic ketoacidosis see Ketoacidosis Duration of insulin action The length of time that certain types of insulin remain active and available in your body after a correction bolus This duration can vary greatly depending on the type of insulin you take Only use rapid acting insulin with the OmniPod Insulin Management System Extended bolus A feature of the OmniPod System that allows a meal bolus dose to be given over an extended period of time Fat One of the three main energy sources in food the other two are carbohydrate and protein Fat is a concentrated source of energy providing 9 calories per gram Foods high in fat include oils mar garine salad
160. ost reliable way to avoid DKA is by checking your blood glucose at least 4 6 times a day Routine checks allow you to identify and treat high blood glucose before DKA develops To treat DKA Once you have begun treatment for high blood glucose check for ketones Check for ketones any time your blood glucose is 250 mg dL or above e If ketones are negative or trace continue treating for high blood glucose e If ketones are present and you are feeling nauseated or ill immediately call your healthcare provider for guidance e If ketones are positive but you are not feeling nauseated or ill replace the Pod using a new vial of insulin Check blood glucose again after 2 hours If blood glucose level has not declined immediately call your healthcare provider for guidance If you need emergency attention ask a friend or family member to take you to the emergency room or call an ambulance Do NOT drive yourself 118 Living with Diabetes 9 Handling Special Situations Follow your healthcare provider s guidelines for taking addi en a tional insulin on sick days Sick days Drink plenty of noncaffeinated fluids to prevent dehydration Any physical stress can cause your blood glucose to rise and ill Note Ifyou are well enough to eat drink sugar free bever ness is a physical stress Your healthcare provider can help you ages However if you are too sick to eat solid foods make a plan for sick days The followi
161. ou pre pare for these situations Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag See the end of the Appendices for address telephone and web site information 120 Errors Advisories and Hazard Alarms Safety Checks The OmniPod System has a very important safety feature It can check its own functions and let you know when something needs attention When you turn on the Personal Diabetes Man ager PDM the System automatically performs a series of safety checks To make you aware of a serious or potentially serious condition the System sounds an alarm and displays an on screen message The message has instructions for taking care of the alarm condition Alarm conditions are easy to handle They are not a problem if you attend to them promptly Check your blood glucose level frequently Blood Glucose Meter Error Messages These messages let you know about an error in the blood glu cose meter test strip sample or results The PDM beeps and displays an error message number as in Figure 10 1 A m 3 00p 2 11 Meter Error 1 See user manual for further instructions Status The following table explains what the message could mean and what you should do 121 10 Errors Advisories and Hazard Alarms Meter Error 1 See user manual for further instructions Meter Error 2 See user manual for further ins
162. out adjusting your basal pro grams or using a temporary temp basal rate Do NOT exercise when ketones are present Blood glucose increases with exercise when ketones are present Consult healthcare provider for guidance See Sick days later in this chapter Consult your healthcare provider about sick day guidelines and about medication changes Living with Diabetes 9 Weight loss or gain Consult your healthcare provider for guidance Menstrual cycle Pregnancy note Check with your healthcare provider for guidance on any i of the causes or suggested actions above 117 9 Living with Diabetes Diabetic ketoacidosis DKA Insulin Pods use rapid acting insulin so you have no long acting insulin in your body If insulin delivery from the Pod is interrupted an occlusion your blood glucose can rise rapidly and lead to diabetic ketoacidosis DKA DKA is a serious but totally pre ventable emergency that can occur if you ignore high blood glucose levels Somme If left untreated DKA can cause breathing difficulties NY shock coma and eventually death 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 blood glucose and check for ketones to rule out DKA To avoid DKA The easiest and m
163. ow AEN Wy V When a hazard alarm occurs in the Pod all insulin delivery stops Failing to address the situation could result in hyperglycemia If you had a temp basal or extended bolus running when the hazard occurred the PDM will remind you of this Many hazard alarms such as Auto off will cause alert escalation and deactivation of the active Pod if ignored Be sure to respond to all alerts and alarms when they occur For a hazard alarm caused by a PDM error or System error that displays Call customer support remove the Pod and call 800 591 3455 immediately for Customer Care from outside the United States 781 457 5098 C CAUTION V Due to the serious nature of hazard alarms you must act promptly to resolve them 1 Acknowledge the alarm condition by pressing OK which silences the alarm 2 Deactivate and remove the active Pod see Chap ter 5 Using the Pod 3 Activate and apply a new Pod see Chapter 5 Using the Pod If you ever need to return the PDM for repair or replacement contact your healthcare provider for instructions on going back to treatment by injections Use the form at the end of this User Guide to write down all your settings from the Setup Wizard You can also attach a copy of the pump therapy orders that you used during your training session If you ever need to reset your PDM having these settings handy will make setup very easy 126 Errors Advisories and
164. ow the rates then press Enter to choose Suspend cancel then press Select 2 Choose Cancel temp basal Figure 3 13 then press Select K 3 00p 2 11 K 3 00p 2 11 Enter temp basal rate Enter temp basal o ETT change es Cancel temp basal Suspend insulin delivery 0 50uh 20 Back Enter Back Enter Back Select note During initial setup you and your healthcare provider ma either turned Off temporary basal rates or chose to 3 Press Confirm to cancel the temporary basal shown on the show the rates as or U hr To change this setting see screen Chapter 6 Using the Personal Diabetes Manager 4 Enter the duration for the temporary rate then press Enter 5 Press Confirm to start the temporary basal rate shown on the screen The Pod beeps to indicate that the temporary basal rate is running 24 Understanding and Adjusting Basal Rates 3 Create a temporary basal preset 1 On the Home screen use the Up Down Controller buttons A A OOP AT to choose Settings then press Select Sol 00p 2 11 Edit name Choose Presets then press Select Aerobics Choose Temp basal presets then press Select Choose add new then press New Mt oe wN To use the OmniPod System s default naming system simply press Next The default naming system automatically assigns program names in numerical order such as temp basal 1 temp basal 2 temp basal 3 Or t
165. p therapy orders that you used during your training session If you ever need to reset your PDM having these settings handy will make setup very easy Resources for OmniPod System users are available from the Customer Care tab on our Web site MyOmniPod com Among these resources are an online copy of this User Guide and the My OmniPod System Information form which you will also find at the end of this guide Understanding and Adjusting Basal Rates What Is a Basal Rate A basal rate is a small base or background amount of insulin that is delivered at a preset rate continuously for a specified period of time Even without eating our bodies need a small constant supply of insulin for normal daily living In people without diabetes the pancreas continuously delivers this basal insulin For people using the OmniPod Insulin Management System the Pod mim ics a healthy pancreas by delivering insulin at the rate that you ve programmed into the Personal Diabetes Manager PDM note Approximately 50 of a person s total daily insulin dose m typically comes from basal insulin delivery the remain ing 50 typically comes from bolus doses see Chapter 4 Understanding and Delivering Bolus Doses Personalized Basal Programs Insulin needs vary throughout the day Therefore most people set their basal rates to deliver slightly more or less insulin at certain times For example one person may need to deliver a higher ra
166. place it in or near water Do NOT use IV Prep wipes alcohol swabs soap detergent or solvents to clean the screen or any other part of the PDM 74 Using the Personal Diabetes Manager Avoid extreme temperatures Extreme operating temperatures can affect PDM batteries and interfere with System operation Avoid using the PDM in temper atures below 40 F 5 C or above 104 F 40 C Do not store or leave the PDM where it may be exposed to extreme temperatures such as inside a car Extreme heat or cold can cause the device to malfunction Never attempt to test your blood glucose while your PDM is connected via USB cable to a computer Doing so could result in electrical shock Electrical interference The PDM is designed to withstand normal radio interference and electromagnetic fields However as with all wireless communica tion technology certain operating conditions can interrupt communication For example electric appliances such as micro wave ovens and electric machinery located in manufacturing environments may cause interference In most cases interrup tions are easy to resolve see Chapter 11 Communication Failures ATAA Wy 6 Only connect a USB cable to your PDM when down loading data to a computer Other PDM functions are disabled while a USB cable is connected and the PDM cannot communicate with the Pod The PDM is compatible only with Windows based operating systems Do not
167. possibility of site infection do NOT apply a Pod without first using aseptic technique This means to e Wash your hands e Clean the insulin vial with an alcohol prep swab e Clean the infusion site with soap and water e Keep sterile materials away from any possible germs Do NOT use a Pod if you are sensitive to or have allergies to acrylic adhesives or have fragile or easily damaged skin Check often to make sure the Pod and soft cannula are securely attached and in place A loose or dislodged cannula may interrupt insulin delivery Do NOT apply a new Pod until you have deactivated and removed the old Pod A Pod that has not been deactivated properly may continue to deliver insulin as programmed put ting you at risk of overinfusion and possible hypoglycemia Because insulin Pods use only rapid acting insulin users are at increased risk for developing hyperglycemia high blood glucose if insulin delivery is interrupted If it is untreated severe hyperglycemia can quickly lead to diabetic ketoacido sis DKA DKA can cause breathing difficulties shock coma or death If insulin delivery is interrupted for any reason you may need to replace the missing insulin usually with an injection of rapid acting insulin Ask your healthcare provider for instructions on handling interrupted insulin delivery 43 5 Using the Pod Gather equipment and supplies Gather the following before you begin e Vial of rapid acting U 100
168. pport 103 reference food library 4 3 reminder alerts ceceeeaes 66 remove a Pod 5 44 45 119 rename basal program e cece ees 22 bolus presets ccc cece eens 39 custom alerts cece ees 68 temporary basal presets 27 replace batteries 0c e eee 138 reset GAlO i sakeindedhaesusekedentuddeain 61 POM eerie OEE ERT 73 NE ederr ern EE 60 FOSOUICES anauen EE ER 162 American Diabetes Association 162 International Association for Medical Assistance to Travelers 162 Juvenile Diabetes Research Founda tion International 162 Medic Alert Foundation 162 National Institute of Diabetes amp Diges tive amp Kidney Disease NIDDK 162 resume insulin delivery 56 reverse correction 14 33 63 65 140 167 175 alerts and alarms 00 8 automatic PriMiINg ee eee 7 automatic safety checks 7 electrical 005 149 152 occlusion detection 7 Safety CHECKS ecceceeeeeees 121 screen time out cece eee eee 71 sensitivity factor See correction factor set backlight time out 72 PDOMINOCK stances cnaswspentiecasmunss 72 screen time OUt 0005 72 settings BG meter cece eens 69 Setup Wiad escenari 11 SEa E E E A A E T 168 sharps contai
169. privacy insulet com Furthermore if you believe that Insulet has violated your privacy rights with respect to your Medical Information you have the right to file a complaint in writing with our Privacy Officer or with the Secretary of Health and Human Services at 200 Independence Avenue S W Washington D C 20201 or by calling 202 619 0257 161 Appendices Helpful Resources American Diabetes Association 1660 Duke Street Alexandria VA 22314 800 342 2383 www diabetes org International Association for Medical Assistance to Travelers List of doctors in foreign countries who speak English and who received post graduate education in the US or Great Britain 417 Center Street e Lewiston NY 14092 716 754 4883 Juvenile Diabetes Research Foundation International 120 Wall Street e New York NY 10005 4001 800 533 2873 www jdf org Medic Alert Foundation To order medical ID necklaces and bracelets PO Box 1009 Turlock CA 95381 1009 800 432 5378 www medicalert org National Institute of Diabetes amp Digestive amp Kidney Disease NIDDK National Institutes of Health Building 31 Center Drive MSC 2560 Bethesda MD 20892 2560 www niddk nih gov health diabetes diabetes htm 162 Glossary Alc see Hemoglobin A1c Advisory alarm Notification by the PDM that a serious condition exists Aseptic technique A method for maintaining sterilization and preventing contamination Basal program One
170. quest or other lawful process Law Enforcement We may disclose Medical Information as long as applicable legal requirements are met for law enforcement purposes These law enforcement purposes include i legal processes otherwise required by law ii limited information requests for identification and location purposes iii pertaining to victims of a crime iv suspicion that death has occurred as a result of criminal conduct v in the event that a crime occurs on the premises of the practice and vi medical emergency in which it is likely that a crime has occurred Research We may disclose your Medical Information to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your Medical Information 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 Military Activity and National Security When the appropriate conditions apply we may use or disclose Medical Information of individuals who are Armed Forces personnel i for activities deemed necessary by appropriate military
171. r 94 Checking Your Blood Glucose 7 Low and High Blood Glucose Readings y_N WARNINGS LOW or HIGH blood glucose readings can indicate a poten tially serious condition requiring immediate medical attention If left untreated this situation can quickly lead to diabetic keto acidosis DKA shock coma or death Low readings If your reading is below 20 mg dL the PDM displays LOW Treat your low BG This indicates severe hypoglycemia low blood glucose Low reading with symptoms If you get a LOW Treat your low BG reading and feel symptoms such as weakness sweating nervousness headache or confu sion follow your healthcare provider s recommendation to treat hypoglycemia Low reading without symptoms If you get a LOW Treat your low BG reading but have no symp toms of low blood glucose retest with a new strip If you still get a LOW Treat your low BG reading follow your healthcare pro vider s recommendation to treat hypoglycemia High readings If your reading is above 500 mg dL the PDM displays HIGH Check for ketones This indicates severe hyperglycemia high blood glucose High reading with symptoms If you get a HIGH Check for ketones reading and feel symp toms such as fatigue thirst excess urination or blurry vision follow your healthcare provider s recommendation to treat hyperglycemia High reading without symptoms If you get a HIGH Check
172. r soccer league For women a monthly hormonal change that affects blood glucose is an example of predictable change To easily handle predictable short term changes you can preset a temporary basal rate so it is ready whenever you need it The PDM can remember up to 7 temporary basal presets You can set a temporary basal rate for a duration of 30 minutes to 12 hours Once the time limit is reached the PDM returns to the active basal program When using units per hour the OmniPod System allows you to set temporary basal rates from 0 0 U hr up to your max basal rate When using percent rate you can set temporary basal rates from 100 to 95 of your active rate as long as the temporary rate is less than or equal to your max basal rate See the sections below on creating enabling canceling and changing temporary basal presets Enable a one time temporary basal rate 1 On the Home screen use the Up Down Controller buttons to choose Temp basal then press Select 2 Ifyou have created temp basal presets choose enter manu ally from the list then press Select If you have not created any temp basal presets the PDM skips this step 23 3 Understanding and Adjusting Basal Rates 3 Enter the temporary basal rate in either units per hour Figure Cancel a one time temporary basal rate 3 11 or percent change Figure 3 12 depending on how 1 On the Home screen use the Up Down Controller buttons you chose to sh
173. rate delivered through out the day and night see Chapter 3 Understanding and Adjusting Basal Rates The size of a bolus dose depends on the factors current at the time you deliver the bolus Your blood glucose level Your insulin to carbohydrate ratio Your correction factor e Your target blood glucose The amount of insulin on board active insulin e Your correction threshold the BG level above which you would like to take insulin to reduce an elevated blood glucose e Your activity level e The type and amount of food you eat With the OmniPod System it is easy to adapt to any situation With just a few button presses you can adjust to unexpected or changing insulin needs During setup you entered bolus dose settings in the PDM see Chapter 2 Getting Started You can adjust these settings as you fine tune your System or when your needs change see Chapter 6 Using the Personal Diabetes Manager nore Check with your healthcare provider before you adjust these settings 29 4 Understanding and Delivering Bolus Doses Bolus Dose Options So that you can fully enjoy freedom and flexibility in your life the OmniPod System offers the following bolus dose options Suggested bolus calculator When you want the System to calculate your suggested bolus based on your personal settings your current blood glucose the amount of insulin still active in your body from previous correction boluses and th
174. rating 75 144 146 Storage esnaera nadra aR 144 temporary basal 12 65 temporary basal presets 25 27 168 CANGGl EE E nevausae 26 MANGE eisai EE 27 EEE EE tla cee ees 25 delete 6d slew daieu dane nalbaene daa as 27 enable c cece cece eee eeeees 26 176 FENEIMEC serrera 27 temporary basal rate 23 27 168 temporary basal rate one time 23 test SDS Midvanivdsdosavaaaee 2 77 79 85 GOCE E T E E 86 EX DINAUION eee a a 77 text entering and changing18 22 25 27 38 39 time segment See basal segment TIME ZONES h dcusccdewsGatdasctteaase 108 CHANING sets ceoseiee wn saeseow ees asases 9 travel Concerns cece eee ee eens 108 U Up Down Controller button 5 xii User Info Support DURON orana ere RA 5 103 COM EEE E E E E 5 SCEN e A ANNEE 103 V VAGAUION catair TN EEATT 108 W WINAY eias i aAA EET 155 Watel eani eiA 74 107 138 WV ED SIG aaar EA xi wireless communication technology 75 X KNANS EEEE clam eduaeeagied s 109 120 177 My PDM Settings Use this form to keep track of your important PDM settings Remember to update your information as you change or add settings This form along with other resources is available on the Insulet Corporation Web site MyOmniPod com Name 12 00 AM to to to to to to Target BG correct to values for Target BG each time segment defined starting at midn
175. reen Figure 7 31 The time the test takes depends on your blood glucose level The higher your glucose level the longer it takes to get a result When your blood glucose level is in the range of 100 to 150 mg dL a result appears in an average of 7 seconds 90 Checking Your Blood Glucose 7 4 Tomarkthe result as a pre or post meal test to indicate a b Press OK to return to the reading screen Figure 7 31 on level of exercise or to indicate other situations connected to the previous page then press Next this blood glucose reading press Tag Then a Use the Up Down Controller buttons to select a tag l then press Select Figure 7 32 You can select a second note lf the suggested bolus calculator feature is turned Off tag for the reading in the same way the Bolus soft key appears instead of Next 5 Ifyou do not want to mark the test press Next instead of Tag 6 Remove the test strip If the strip port light was turned on it now turns off 3 00p 2 11 Select BG tag Remove the lancet Control When you have finished testing snap off the cap from the Pre meal lancing device Hold the lancet over a sharps container or a Post meal puncture proof container with a lid Pinch the white clip that Missed bolus holds the lancet until the lancet falls out Figure 7 33 Carb guess Basal evaluation start LnF Basal evaluation stop p Skipped meal at a OK Select d To learn how to
176. ring out the correct program can be more challenging Your health care provider can help with these adjustments Take enough supplies Keeping your emergency kit with you during trips or vacations is especially important see Prepare for Emergencies earlier in this chapter It may be difficult or impossible to get insulin or supplies in an unfamiliar place If traveling by air be sure to pack your supplies in your carry on luggage When packing for travel take more supplies than you think you ll need Be sure to include e Diabetes emergency kit packed in your carry on luggage Enough Pods for your trip plus a backup supply Extra new PDM batteries e Additional blood glucose meter Insulin syringes or pens in case you need injections Several vials of insulin or insulin cartridges if you use a pen Glucagon kit Make sure any person you are traveling with knows how to give the injection Alcohol prep swabs Written prescriptions for all medications and supplies Generic medications may be easier to find than brand names outside the US When you travel outside the country or for long periods of time be sure to take extra Pod supplies Call 800 591 3455 from outside the United States 781 457 5098 to order additional supplies for your trip 108 Living with Diabetes 9 Minimize airport security delays Contact the airlines in advance for information on their current security requirements To make ai
177. roximately 20 units during your work day and the insulin gauge shows only 17 units remaining you can either take a new Pod with you or change it before you leave for the day PDM settings You can adjust the PDM settings to meet your individual needs 1 From the Status screens press Home 2 Use the Up Down Controller buttons to choose Settings 3 4 Choose an option from the System setup list then press then press Select Choose System setup then press Select Select Figure 6 2 Check with your healthcare provider before making any changes PP 300p 2m1 Date time gt Bolus basal calcs gt Alerts reminders gt BG meter gt PDM options Diagnostics gt Back Select 59 6 Using the Personal Diabetes Manager The System Setup Menu The System setup menu lets you personalize the settings that control the OmniPod System These include e Date and time e Bolus doses basal rates and bolus calculator settings e Alerts and reminders e Blood glucose meter settings e Blood glucose tags e PDM options e Diagnostics You and your healthcare provider entered initial System settings using the Setup Wizard see Chapter 2 Getting Started After setup you can use the System setup menu to customize or change those settings as described in this chapter Reset the Date or Time Occasionally you need to change date and time settings for example to adjust for daylight savings time or
178. rport security checks go smoothly be sure you have the following easily accessible A signed letter from your healthcare provider explaining that you need to carry insulin supplies and OmniPod System equipment An emergency kit see Prepare for Emergencies earlier in this chapter A list of the supplies you must carry including the contents of your emergency kit Prescriptions for insulin and all supplies clearly marked with their original pharmacy labels If the security detector goes off tell the security screener that you have diabetes and wear an insulin Pod pump NOTE Pods and PDMs can safely pass through airport X ray machines see the FCC notice in the Appendices Keep supplies accessible On airplanes and trains keep these items with you rather than checking them Personal Diabetes Manager PDM An emergency kit Vials of insulin cargo area temperatures may affect insulin A copy of your healthcare provider s letter see Minimize air port security delays Prescriptions for insulin and supplies Snacks in case food is not available Bottled water especially on planes to prevent dehydration The name and phone number of a physician at your final destination in case of emergency 109 9 Living with Diabetes Avoid Lows Highs and DKA You can avoid most risks related to using the OmniPod System by practicing proper techniques and by acting promptly at the first sign of trouble You can
179. rts that may be dangerous if before meals and before bed swallowed time However when blood glucose is changing it is best to test on your fingers Blood from the fingertips may show these changes sooner than blood from other sites 76 Checking Your Blood Glucose 7 Only use FreeStyle test strips and FreeStyle control solution with the OmniPod System Using other brands of test strips and control solutions with the OmniPod System can produce inaccurate results Please read all the instructions provided in this User Guide and practice the testing procedures before using the OmniPod System and FreeStyle accesso ries Follow the guidance of a healthcare professional for proper blood glucose monitoring Never attempt to test your blood glucose while your PDM is connected via USB cable to a computer Doing so could result in electrical shock The FreeStyle Blood Glucose Test Strips Important test strip information Store the blood glucose test strip package in a cool dry place between 37 and 86 F 3 and 30 C Use test strips only when the System is within its operating temperature range between 40 and 104 F 5 and 40 C e Keep test strips away from direct sunlight and heat e Store test strips in their original vial only never transfer them to another vial or any other container e Never store individual test strips outside the vial After removing a blood glucose t
180. s Doses 4 Change a bolus preset 1 Choose Edit then press Select 2 Enter anew insulin amount for the bolus then press Save Rename a bolus preset 1 Choose Rename then press Select 2 Press the Up Down Controller buttons to enter the charac ters that spell out the name you want then press Next Delete a bolus preset 1 Choose Delete and then press Select 2 Press Delete to permanently delete the preset Cancel an active bolus preset 1 Press and hold the Power button to turn on the PDM if it is not already on An on screen message appears as long as a bolus is being delivered 2 Press Cancel The Pod beeps to confirm the bolus is canceled An on screen message tells you how much insulin was delivered before you canceled the bolus 3 Press OK to return to the Status screen For more details see Cancel Active Boluses earlier in this chapter Carb Presets Carb presets are favorite food items snacks or meals that you eat frequently After you enter these items you can quickly select one when entering carbs during the suggested bolus calculator process Create a carb preset 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Presets then press Select Choose Carb presets then press Select Choose the category for this carb preset Favorites Snacks or Meals then press Select Choose add new then press New To use the Omni
181. s and the interruptions that come with them In addi The OmniPod Insulin Management System is an innovative tion with the OmniPod System insulin delivery can be changed continuous insulin delivery system that provides all the proven with the press of a button to adapt to snacks or unexpected benefits of continuous subcutaneous insulin infusion CSII therapy changes in daily routine The OmniPod System is a great option ina Way No conventional insulin pump can The System s innova for people with diabetes who require insulin tive design and features allows you to live your life and manage your diabetes with unprecedented freedom comfort convenience and ease The OmniPod System works much like the pancreas of a person without diabetes by delivering insulin in two ways e Asmall constant background supply of insulin called a basal The long term health benefits of better blood glucose control rate is delivered automatically at a programmed rate all day are well known Maintaining near normal blood glucose levels E i and night can help you live a longer healthier life with fewer diabetes J no l related complications The OmniPod System also has many Anextra dose of insulin called a bolus can be delivered practical everyday benefits including convenience freedom when you need it to match the carbohydrates in a meal or flexibility and ease of use snack or to correct a high blood glucose Continuous insulin delivery most
182. s blood glucose level is below their blood glucose target This feature is an option in the OmniPod Insulin Management System which should be turned on or off according to the advice of a healthcare provider Sensitivity factor see correction factor 167 Sharps Any medical item that may cause punctures or cuts to those handling them Sharps include needles syringes scalpel blades disposable razors and broken medical glassware Dispose of used sharps according to local waste disposal regulations Sharps container A puncture proof container used for storage and disposal of used sharps Soft key A button on the PDM whose label or function appears on the screen directly above the button The label changes depending on the task you are performing Subcutaneous Under the skin Suggested bolus calculator A feature that calculates bolus doses with user specific settings and inputs The settings used to calculate a suggested bolus are target BG insulin to carbohydrate IC ratio correction factor CF and duration of insulin action The inputs used to calculate a sug gested bolus are current BG carbs entered and insulin on board from previous correction boluses The bolus calculator can be turned Off or On in the PDM Target blood glucose level The ideal number at which you would like your blood glucose level to be The OmniPod System uses this number in calculating bolus doses Temp basal A basal rate that
183. s day 4 Avg BG 106 mg dL Min max 76 155 mg dL 200 BG goal 80 150 mg dL Within goal 86 Above goal 6 Below goal 6 Back 7 day 101 8 Understanding Your Records 5 Forthe 7 14 and 30 day trends press Graph to see a graph of the trends Figure 8 11 Graphs are not available for 60 or 90 day trends Press Stats to return to the detail view Alarm Records The PDM lists the entire alarm history for the OmniPod System i 12a 6a 12p 6p 12a Back 7 day Stats Back 6 Press Back to return to the single day trends The PDM can store over 90 days worth of alarm records Is On the Home screen use the Up Down Controller buttons to choose My records then press Select le 11 00p 2 11 D 1200p 2M l 30 day n 30 Alarm history 2 Choose Alarm history then press Select 300 3 11 08 The PDM displays the date time and type of each alarm EE Figure 8 12 3 02p Check pod Figure si 500 zag 3 Press the Up Down Controller buttons to see additional bessere lene echt 6 00p Suspend done SCT SSL 100 Gia oa 4 Choose an alarm record then press User Info Support to ME SO on see more information Carbohydrate Records The PDM displays the record of carbohydrates you have entered 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select Choose Carb history then press Select The PDM d
184. se handling care safety and cleaning Supply Insulet Corporation with insurance information nec essary to obtain payment for services Be accountable for charges not covered by your insurance You are responsible for settlement in full of your account Notify us immediately of a Equipment failure damage or need of supplies b Any change in your prescription or physician c Any change or loss in insurance coverage d Any change of address or telephone number whether permanent or temporary 154 Limited Warranty for the Personal Diabetes Manager Limited Warranty Coverage Insulet Corporation warrants to the original purchaser you that the Per sonal Diabetes Manager the PDM will be free from defects in materials and workmanship under normal use and conditions for a period of four 4 years from the date of purchase If Insulet Corporation determines that the PDM is defective during the warranty period Insulet Corporation will either repair or replace at its option the PDM at no charge to you subject to the conditions and exclusions stated herein This Warranty applies only to new devices and in the event the PDM is repaired or replaced the warranty period shall not be extended Warranty Claim Procedure You must notify Insulet Corporation of the claimed defect within the war ranty period by writing or calling Insulet Corporation 9 Oak Park Drive Bedford Massachusetts 01730 Telephone
185. se Results and the Suggested Bolus Calculator 92 Entering Blood Glucose Readings Manually 93 Editing lags eccrine E A T Cake euameas 93 Low and High Blood Glucose ReadingS 06 95 LOW FOAGINGS trora a n O N 95 PHigntreaddinhgs srsaisosss enia i a tad AO 95 Important Health Related Information 06 96 8 Understanding Your Records ccccccsssceees 97 RECON KECDING oys ade tweeted ee rE EEEN PUNKERA 97 Special symbols in record screens cece cece eee ee ees 97 Insulin Delivery Records ccc ce cece cece eeeeeeeees 98 View insulin delivery records ceeeeccceeeeeeeeeees 98 Blood Glucose Records ccceceececececncnceenes 100 View single day trends cecccccseecccceeeneeeeees 100 View multiple day trends ccceeeeeeceeeeeeeeeees 101 Alain RECONDS ise caceide gerrara S agndeaeuas 102 Carbohydrate Records cceceecececeeeeeeneeees 102 Pl REGOWOS dutta gcse cay ulasamamieaian wast ayaa ened 103 User Information Support cece cece cece ences 103 Add or change user information cccceeeeeeeees 104 Living with Diabetes cccccccccccccccccccees 105 Your Role Safely Using the OmniPod System 105 Daily Diabetes Management Activities 06 106 Check your blood glucose frequently 00 eee eee 106 Inspect the infusion site daily cce cece eeeeeeees 106 Pr
186. se the bolus reminder you wish to edit then press Edit b Choose Edit then press Select c Enter anew start time then press Next d Enter anew end time then press Save To delete a Bolus reminder a Choose the bolus reminder you wish to delete then press Edit b Choose Delete then press Select c Press Delete to remove the bolus reminder 7 For Custom alerts Use the Up Down Controller buttons to choose add new then press New To use the OmniPod System s default naming system sim ply press Next The default naming system automatically assigns alert names in numerical order such as alert 1 alert 2 alert 3 If you want to give a different name to the custom alert a Use the Up Down Controller buttons to scroll through the list of characters An up and down arrow symbol on the screen indicates the character you are changing b Press the middle soft key to move the underscore to the next character c Enter each character one at a time For example fora reminder to pick up a prescription you might enter R x Figure 6 9 on next page A blank character or space is the first and last option in the scrolling menu 68 Using the Personal Diabetes Manager 6 Change Blood Glucose Meter Settings wr 300p_ 2 11 S 3800p 2 11 You can adjust blood glucose BG meter settings Edit name BG goal 100 110 mga BG goal lower and upper limits for BG history Rx Manage BG tag lis
187. sesivie vanes ud areata 136 Ceactivating ececeeeees 44 TING E E E 46 flow ACCULACY 0 cece e eee e ees 145 flow rate error eee eee eee 145 in water ssnssensssesereesso 57 inserting cannula 52 olaan la o E E E A E ET 48 FOMOVAl ey aa 44 45 119 Safety CHECkKS 0ceeeeeees 48 Specifications ece cece 144 Oe e ecb w uae ede 57 136 Pod error hazard alarm 128 Pod expiration cece cee ee es 66 Pod expiration advisory 124 Pod expiration alert 5 124 Pod expired hazard alarm 127 Pod occlusion hazard alarm 127 DIESCIIDTIONS Akexecc casuesaetiewedscures 109 TOR WAVE linc sssceoeietiadeeSaeateures 108 prime DOlUS cece cece eee 53 167 priming automatic cea 7 product information 103 program alerts See reminder alerts Proteo reine sea eenesect ees 167 R radio interference ccc e eee 75 rapid acting insulin 118 Ratios factors targets option 64 65 record keeping 3 97 104 record SCFEENS cece cece eee 97 104 eE a AEE EEE ET E 102 o EES AEE ATES 103 blood glucose 008 100 carbohydrates 008 102 combined records 103 insulin delivery ceeees 98 personal contact information 103 Special symbols 97 101 User Info Su
188. ss OK to acknow Insulin delivery stopped z i ledge Memory corruption ledge Change pod now Change Pod Press Ok to reset PDM Change Pod and delete all user set Check blood glucose tings History records will Check blood glucose PDM Error PDM Press OK to acknow not be deleted Remove pod now ledge System Error PDM Press OK to acknow Call customer support Remove Pod Remove pod now or ledge A Call Customer Care at Call customer support Pod Remove Pod Ref 05 100 0618 00000 800 591 3455 f 800 591 3455 O AE om E TT Call Customer Care at outside the United ef 0 gt 100 j 800 591 3455 from States 781 457 5098 outside the United Check blood glucose States 781 457 5098 Check blood glucose 128 Communication Failures The Communication Process Failure During Pod Activation or Operation When you turn on or use the Personal Diabetes Manager PDM When you send an instruction from the PDM such as Start to it establishes communication with the active Pod Usually com begin bolus delivery or Enable to begin using a different basal munication occurs quickly Occasionally communication takes program the Pod usually responds quickly However if the longer and the PDM displays the communication icon during PDM cannot send your instruction within a few seconds it dis that time in the upper left hand corner of the current screen plays the Communication error screen Figure 11 1 on the next Howev
189. st strip Do not press any buttons or soft keys while applying blood or control solution to the test strip Ifthe error persists call Customer Care at 800 591 3455 from outside the United States 781 457 5098 123 10 Errors Advisories and Hazard Alarms Advisory Alarms Some advisory alarms are controlled by levels you set in the Set tings screen One example is the level at which the Low Advisory alarms tell you about a condition that requires your reservoir volume alarm sounds attention Each advisory alarm beeps intermittently When you hear an advisory alarm first turn on the PDM to display the Sta tus screen The PDM communicates with the Pod if necessary and the screen displays a message describing the alarm and how All advisory alarms are time sensitive and require a response Some advisory alarms escalate to hazard alarms if you do not respond within a certain time period as noted in the table to resolve it GEO Low reservoir Pod 2 sets of beeps every minute for 3 minutes Press OK to acknowledge Replace pod soon A Repeats every 60 minutes until acknowledged Escalates to hazard alarm when empty See This is based on the volume Hazard Alarms later in this chapter level you selected Expiration alert Pod 2 sets of beeps every minute for 3 minutes Press OK to acknowledge Pod expires at 5 00 pm 2 11 Repeats every 15 minutes until acknowledged Change Pod see Chapter 5 Using the Pod P
190. step through the screens 6 Press Save to update the preset Delete a carb preset 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Presets then press Select Choose Carb presets then press Select Choose the category of the preset you want to change then press Select Choose the carb preset you want to delete then press Edit Press Delete 7 Press Delete again to permanently delete the preset 41 4 Understanding and Delivering Bolus Doses Reference Food Library The OmniPod System includes a reference library of over 1 000 common food items The library shows each item s carbohydrate fat protein fiber and calories for a single portion You can use this information to determine the carbs for a meal or snack you are going to eat You can also use it to help you create carb pre sets for your favorite meals The items in the food library are derived from the USDA data base USDA National Nutrient Database for Standard Reference Release 16 published by the U S Department of Agriculture Agricultural Research Service in 2004 Access the reference food library 1 On the Home screen use the Up Down Controller buttons to choose Food library then press Select The screen displays a list of main food categories Figure 4 16a and Figure 4 16b 2 To choose directly from the food categories choose a main category then press Select Choose a
191. t Manage BG tags list z BG sound On e BGsound On or Off 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose System setup then press Select ee a SS es 3 Choose BG meter then press Select Back r Next Laa eee 4 Choose the setting you want to change Figure 6 10 then d Press Next press Select e Enter the time of day for the alert in 30 minute incre ments then press Next e Choose Daily One time only or Off then press Select nore Custom alerts will repeat every 15 minutes until acknowledged _ You can change or delete alerts and reminders at anytime Change BG goal limits To change the BG goal limits press Edit change either or both values then press Save 69 6 Using the Personal Diabetes Manager Manage the Blood Glucose Tags List You can create up to 15 custom blood glucose tags and hide any of the standard tags you do not plan to use Standard BG tags are shown first on the screen Figure 6 1 1a followed by custom tags then add new Figure 6 1 1b For more information about tagging BG readings see Chapter 7 Checking Your Blood Glucose 3 00p 2 11 Configure the list of available BG tags Standard BG tags v Control v Pre meal v Post meal v Missed bolus v Carb guess v Basal evaluation start Done Hide v Pre bedtime Custom BG tags add new Done 3 00p 2 11
192. te of insulin during the early morning and a lower rate during the late evening A basal program describes the amount of insulin to be delivered during an entire 24 hour period A basal program contains at least one basal rate for the 24 hour period but for most people it will be broken into several time segments or basal segments each delivering a different rate of insulin A sample basal program with three basal segments might be 12 00 am 8 00 am 8 00 am 3 00 pm 3 00 pm 12 00 am 0 60U hr 0 80U hr 0 70U hr Between 12 00 am midnight and 8 00 am the Pod delivers 0 60 units of insulin per hour Between 8 00 am and 3 00 pm the Pod delivers 0 80 units of insulin per hour Between 3 00 pm and 12 00 am midnight the Pod delivers 0 70 units of insulin per hour 3 Understanding and Adjusting Basal Rates In addition to normal daily changes insulin needs can vary with different routines or days of the week For example regular school or workday routines may differ from weekend routines and insulin needs may differ too With your healthcare provider you will decide on the basal rates that best match your lifestyle and insulin needs You will enter at least one basal program your Basal 1 program into your PDM during the setup process see Chapter 2 Getting Started You can add other programs later as you fine tune your System settings or when your needs change You can also create temporary basal pr
193. teps below to view the information You can add or change the user information at any time You may want to include your name address phone email address emergency contact and phone doctor s or healthcare provider s name and phone prescription numbers or other information The user information screen also displays contact information for Insulet Corporation and product information for your OmniPod System make model serial number You cannot change this information 103 8 Understanding Your Records The User Info Support icon is also displayed on the suggested bolus screen For information about the support information displayed on these screens see Chapter 4 Understanding and Delivering Bolus Doses Add or change user information 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select Choose My info then press Select Choose My info Figure 8 15 then press Edit i 4200p 2 711 1100p 2 11 John Doe My info Jane Smith 555 1234 My info z My info My info My info My info My info Back Edit Back Save Press the Up Down Controller buttons to scroll through the list of characters An up and down arrow symbol on the screen indicates the character you are changing Press the middle soft key to move the underscore to the next character Enter each character one at a time F
194. ter Keeping a diabetes emergency kit with you at all times See Prepare for Emergencies later in this chapter Knowing how to contact your healthcare provider in case of an emergency Koa If you are unable to use the OmniPod Insulin Man NY agement System according to instructions you may be putting your health and safety at risk Talk with your healthcare provider if you have questions or con cerns about using the OmniPod System 105 9 Living with Diabetes Daily Diabetes Management Activities To ensure proper OmniPod System operation and your contin ued good health Check your blood glucose frequently e Inspect the infusion site daily Check your blood glucose frequently When you routinely check your blood glucose level you can iden tify and treat high or low blood glucose before it becomes a problem see Avoid Lows Highs and DKA later in this chapter Check your blood glucose BG e Atleast 4 to 6 times a day when you wake up before every meal and before going to bed e Whenever you feel nauseated or sick e Before driving a car Whenever your blood glucose has been running unusually high or low e Ifyou suspect that your blood glucose is high or low e Before during and after exercise e As directed by your healthcare provider Inspect the infusion site daily At least once a day use the Pod s viewing window to inspect the infusion site Check the site for signs of infect
195. ter ack Enter 5 Press Confirm to begin the bolus delivery To learn how to set extended boluses in percentages or units see Chapter 6 Using the Personal Diabetes Manager 35 4 Understanding and Delivering Bolus Doses NOTE NOTE As a safety feature the correction bolus is always delivered first and cannot be extended Only the meal bolus can be extended For example Total bolus 5 units Correction bolus 1 unit Meal bolus 4 units Deliver now 2 units 100 of correction bolus 1 unit 25 of meal bolus 1 unit Extend 3 units 75 of meal portion 3 units As a Safety feature you cannot deliver two extended boluses at the same time You can deliver a normal bolus while an extended bolus is being delivered Cancel Active Boluses The OmniPod System is extremely flexible so you can use it to respond to your changing insulin needs It is easy to cancel an active bolus one that is currently being delivered even after insulin delivery has started 1 Press and hold the Power button to turn on the PDM if it is not already on An on screen message appears as long as a normal bolus is being delivered Figure 4 9 0 300p 2 11 Delivering bolus we 1 50u Cancel 36 Understanding and Delivering Bolus Doses 4 NOTE Bolus Presets If the bolus has already been completely delivered the Delivering bolus message and Cancel do not appear but the Status screen
196. tion use the Up Down Controller buttons to choose On or Off then press Next If you enter carbs and reverse corrections are On the System will subtract insulin from the suggested meal bolus to compensate for a low blood glucose below the BG target you set With reverse correction Off the System will not subtract insulin from the sug gested meal bolus dose due to a low BG Follow your healthcare provider s recommendation to set reverse correction On or Off 14 Getting Started 2 Enter the duration of insulin action Set low reservoir alert 1 Use the Up Down Controller buttons to enter the duration 1 Choose the level of insulin in the reservoir at which the of insulin action how long insulin lasts in your body then PDM should give you an alarm Choose from 10 to 50 units press Next in 5 unit increments then press Next note The duration of insulin action setting is used to The PDM now asks whether you want to activate a Pod calculate the amount of insulin on board IOB from Figure 2 4 a previous correction bolus when you use the sug gested bolus calculator A 00211 Select bolus increment and enter maximum bolus Your OmniPod Insulin 1 Choose a bolus increment how much each press of the a System Is Up Down Controller buttons will increase or decrease a ready to use bolus amount either 0 05 0 10 0 50 or 1 00 units of insu lin then press Next beat cael ag activate a pod now 2 Choose the max
197. to use the System according to instructions you may be putting your health and Safety at risk Talk with your healthcare provider if you have questions or concerns about using the System properly Introduction ee Wy The OmniPod System is designed to use rapid act ing U 100 insulin The following U 100 rapid acting insulin analogs have been tested and found to be safe for use in the Pod Novolog Humalog or Apidra Before using a different insulin with the OmniPod System check the insulin drug label to make sure it can be used with a pump Refer to the insulin labeling and follow your healthcare provider s directions for how often to replace the Pod Please read all the instructions provided in this User Guide and practice the blood glucose testing proce dures before using the System Monitor your blood glucose with the guidance of your healthcare pro vider Undetected hyperglycemia or hypoglycemia can result without proper monitoring Screen displays shown in this User Guide are for illustra tive purposes only and should not be considered suggestions for user settings Consult with your health care provider to determine the appropriate settings for you You and your healthcare provider Work with your healthcare provider to establish diabetes man agement guidelines and settings that best fit your needs These may include Insulin to Carbohydrate Ratio Number of grams of carbo
198. tons to enter the charac ters that spell out the name you want then press Save 3 Press Done To delete a temporary basal preset 1 Choose Delete then press Select 2 Press Delete to permanently delete the preset 27 3 Understanding and Adjusting Basal Rates Maximum Basal Rate What is the maximum basal rate The maximum basal rate is a safety feature that limits the basal rate U hr that the Pod can deliver Once you enter it into the PDM memory the maximum applies to both regular basal pro grams and temporary basal rates You and your healthcare provider will enter an initial maximum basal rate into your PDM during the setup process see Chapter 2 Getting Started You can change it later as you fine tune your System settings or when your needs change Change the maximum basal rate 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose System setup then press Select Choose Bolus basal calcs then press Select Choose Max basal then press Select ie ape 0 Enter anew maximum basal rate then press Enter 28 Understanding and Delivering Bolus Doses What Is a Bolus A bolus is an extra dose of insulin delivered when needed to e Match the carbohydrates sugar content in a meal or snack also known as a meal bolus e Lower blood glucose when it gets too high also known as a correction bolus This extra dose is in addition to the basal
199. tor is On 1 After you check your blood glucose the PDM displays the results Figure 4 1 see the end of Chapter 7 Checking Your Blood Glucose Press Next 300p 2 11 mg dL Calibration code 27 Done Tag Next 31 4 Understanding and Delivering Bolus Doses NOTE NOTE NOTE NOTE A blood glucose value is current for up to 10 minutes after it is tested So you can wait up to 10 minutes restart the bolus process and not have to retest your blood glucose in order to include it in the suggested bolus calculator When your blood glucose result reads HIGH or LOW the suggested bolus calculator will be disabled If you use a separate blood glucose meter not the Personal Diabetes Manager PDM you will need to enter your blood glucose manually On the Home screen choose Bolus then press Select Use the Up Down Controller buttons to enter your current BG value then press Yes if you want this value to be used by the suggested bolus calculator You can also enter a BG manually by choosing the More actions menu then choosing Add BG Read ing See the end of Chapter 7 Checking Your Blood Glucose 2 Ifyou are not going to eat now press No Figure 4 2 The Suggested Bolus screen appears Figure 4 3 Press Enter to accept the suggested bolus Or if you wish press the Up Down Controller buttons to increase or decrease the suggested bolus Then press Enter to accept the bolus
200. tructions Blood sample is too small Problem with the test strip Problem with the meter Very low blood glucose less than 20 mg dL Problem with the test strip Problem with the meter Very high blood glucose above 500 mg dL HIGH control solution applied when temperature is too cold This applies only to control solution labeled HIGH 1 If you have symptoms such as weakness sweating nervousness head ache or confusion follow the recommendations of your healthcare provider for treating hypoglycemia Conducta control solution test using a new test strip If the results of the control solution test are within the range printed on the side of the test strip vial retest using blood and a new test strip Ifthe control solution test does not work or the error persists call Customer Care at 800 591 3455 from outside the United States 781 457 5098 Ifyou have symptoms such as thirst fatigue excess urination or blurry vision follow the recommendations of your healthcare provider for treating hyperglycemia Conducta control solution test using a new test strip If the results of the control solution test are within the range printed on the side of the test strip vial retest using blood and a new test strip Ifthe control solution test does not work or the error persists call Customer Care at 800 591 3455 from outside the United States 781 457 5098 122 Errors Advisories
201. ttings eessen nnn ENEA 12 Enter blood glucose sound setting and BG goal 12 Set the suggested bolus calculator cece eee ee 12 Enter target blood glucose value ccc cece cence ees 13 Enter minimum BG allowed for use in bolus calculation 13 Contents Enter insulin to carbohydrate ratio c ccc eeee eens 13 Enter correction factor cece cece cece ce eeeeeeeeneees 14 Set reverse correction cece cece ence eccenseseesceeenes 14 Enter the duration of insulin action 0ec eee eees 15 Select bolus increment and enter maximum bolus 15 Set extended bolus doses cece cece cece cece cece eees 15 Set low reservoir alert cccc ccc cceeeeeeeeeeeeeeeeees 15 3 Understanding and Adjusting Basal Rates 17 What Is a Basal Rate ccc cece cece cece cee eeeeeeees 17 Personalized Basal Programs ccececeeeeeeeeeee 17 Create a basal program cccccceeececeeeeeeeeeneees 18 Enable an existing basal program seeeeceeeeeeees 20 Change rename copy or delete a basal program 21 Temporary Basal Rates and Presets ceeeeeeeees 23 What is a temporary basal rate cece cece cece eeeees 23 Enable a one time temporary basal rate 00 00 23 Cancel a one time temporary basal rate 6006 24 Create a temporary basal preset cccceeee cece ee
202. ula inserts Occlusions may result in lean areas if you do not use this technique 52 Using the Pod 5 The Pod automatically inserts the soft cannula below your Check the infusion site after insertion to ensure skin It takes a few seconds to complete the insertion process that the cannula was properly inserted It is also a Once the cannula is inserted the Pod delivers a prime bolus to good idea to check your blood glucose about fill the cannula with insulin Figure 5 20 two hours after after each Pod change and to check the infusion site periodically If the cannula is not properly inserted hyperglycemia may result E 3 00p 2 11 3 00p 2 11 Pod is active If you observe blood in the cannula check your blood glucose more frequently to ensure insulin basal 1 has been delivery has not been affected If you experience oa e etl ea eee unexpected elevated blood glucose levels eck infusion site an E ponera change your Pod ls cannula properly Once the soft cannula is inserted the PDM indicates that the inserted Pod is active Figure 5 21 Figure 5 21 also displays a reminder to check the infusion site No Yes and cannula Make sure the Pod is securely attached to your skin You can see the cannula through the small viewing window on the Pod note You will hear a click when the cannula inserts To help avoid condensation from occurring in the viewing window make sure both your Pod and
203. view all settings Target BG Min BG for calcs 70 mg dL IC ratio Correction factor Reverse correction On Insulin action 3 5 hr Back Select Back Select or 3 00p 2 11 1 Target BG and correct above value You can edit existing segments and add segments up to a total of four a To edit an existing target BG time segment choose the segment then press Edit Use the Up Down Controller buttons to choose a new start time end time target BG value and correct above value correction threshold Press Next after each entry To add a segment choose add new then press New Use the Up Down Controller buttons to choose a start time end time target BG value and correct above value correction threshold Press Next after each entry When you have completed all the time segments you want press Done then Save Min BG for calcs minimum blood glucose value allowed for calculating boluses Use the Up Down Controller buttons to enter a new minimum BG then press Enter Insulin to carb IC ratio You can edit existing time seg ments and add segments up to a total of four a To edit an existing IC ratio time segment choose the seg ment then press Edit Use the Up Down Controller but tons to choose a new start time end time and IC ratio Press Next after each entry To add a segment choose add new then press New Use the Up Down Controller buttons to choose a start time end time
204. your insulin are at room temperature 53 5 Using the Pod 2 Press Yes if you can see that the cannula is properly inserted The PDM returns to the Status screen Or press No if you see a problem with the cannula The PDM instructs you to deactivate the new Pod Figure 5 22 Press Discard to restart the process with a new Pod ZA 3 00p 2 11 Press Discard to deactivate pod Back Discard Or press Back to return to the previous screen NEVER inject insulin or anything else into the fill port while the Pod is on your body Doing so may result in unintended or interrupted insulin delivery Check Pod Status To check Pod status if the PDM is turned off press and hold the Power button to display the Status screen If the PDM is on press Back until you reach the Status screen If you press and hold the Power button you will turn off the PDM instead Or from the Home screen press Status The PDM automatically checks the status of the Pod The PDM then displays the current reservoir volume PDM battery level last blood glucose last bolus dose active basal program and any alarm conditions See Chapter 6 Using the Personal Diabetes Manager for details of what you see on the Status screen PDM it can only receive commands from that PDM Once a Pod is activated and communicates with the not from any other If the Pod goes into hazard alarm condition and the PDM is unable to communicate w
205. your prior written authorization as described further below Uses and Disclosures of Your Medical Information Related to the Treatment and Services Provided by Us Treatment Payment and Health Care Operations We may use your Medical Information for treatment to obtain payment for treatment for administrative purposes and to evaluate the quality of care that you receive without your authorization We may use or disclose Medical Information about you without your authorization for several other reasons Example of Treatment In connection with treatment we may use your Medical Information to provide you with one of our medical devices Example of Payment We may use your Medical Information to generate a health insurance claim and to collect payment on invoices for services and or medical devices provided Example of Health Care Operations We may use your Medical Information in order to process and fulfill your orders and to provide you with customer service 156 Appointment Reminder and Other Communications We may use or disclose your Medical Information without your prior written authorization to provide you or others with among other things i appointment reminders ii product supply reorder notifications and or iii information about treatment alternatives or other health related products and services that we provide Family Friends and Emergencies If you require emergency treatment and we are unable to obt
206. ystem review this User Guide and the Pre Training section of OmniPod s online Interactive Training Program found in the Customer Care section of MyOmniPod com If you have a basic understanding of the System in advance you will get more out of your training sessions After you unpack the Starter Kit use the Contents list to make sure you have everything Then complete the warranty card and promptly mail it to us Returning the card allows us to contact you with important product updates or warranty information You can also complete the warranty form online at MyOmniPod com Do NOT use the OmniPod Insulin Management System until you have been trained by your healthcare provider He or she will initialize the System based on your individual needs Inadequate training or improper setup could put your health and safety at risk note Prepare and keep an emergency kit with you at all times i to quickly respond to any diabetes emergency For details see Chapter 9 Living with Diabetes 2 Getting Started E Set Up the Personal Diabetes Manager PDM _ The diagram inside the compartment shows you which Chapter 6 describes the PDM options in detail The instructions direction to insert the batteries Figure 2 2 in this chapter are simplified to help you get started Do not use any other type of batteries than AAA Turn on the PDM alkaline batteries to power the PDM Never use old 1 Open the battery compartment o

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