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Ust400 - New OmniPod Training & Resources

1. Bring the strip to the blood sample at a slight angle Figure 7 25 If you do not apply the sample within 10 seconds the strip port light turns off To turn it on again press Light Use only one edge of the blood glucose test strip per test Do not apply blood to both edges Figure 7 26 on the next page Only use strips once Discard used strips The test strip pulls the blood into the strip through the edge Figure 7 27 on the next page 90 Checking Your Blood Glucose 7 Edge of test strip WARNING The lancing device is intended for individual use and should not be shared If the device is being operated by a second person who is providing testing assis tance to the user the meter and lancing device should be decontaminated prior to use by the sec ond person see Appendix A 1 Do not e Press the strip against the test site e Scrape the blood onto the strip e Apply blood to the flat side of the strip e Apply blood to the strip when it is out of the meter e Put blood or foreign objects into the test strip port Do not pull the test strip away from the sample until you hear 1 beep or see the word Checking on the screen Figure 7 28 This means you applied enough blood and the meter is reading your glucose 3 00p 2 11 6 3 00p 2 11 Checking mg dL N Calibration code 16 Done Tag Next
2. 65 71 temporary basal presets 28 replace batteries 06 141 reset Gale A buss A EA 64 POM ererek 75 76 LING eea aa a 64 resume insulin delivery 59 reverse correction 15 34 66 67 143 169 S Sal E E EE T ES 8 106 alerts and alarmS 06 8 automatic primMing 6 8 automatic safety checks 8 CICCINIGAl ists odedussieeeees 153 156 Safety checks 0cc eee eees 122 screen time out ce eee 73 SCE Mcrae E E A 75 sensitivity factor See correction factor set backlight time out 75 ID Srei s nerra aawedmcusaies 74 PDM lOCKitvenc ands cobedateawnsen 75 screen time OUt 08 75 settings Ba meter 6 72 Setup Wizard ccc ccc e eens 10 AELA c AEL TE neon ENS 169 sharps container 000s 169 SHOCK oeresneer aeoe aeee 45 shut off manual 64 131 SIEK AIV erinan 120 sap Solvent oisirtersrtisi 77 138 SOFt KEYS cece cece eee es ix 5 169 SOM OSCE sae a See reset PDM special symbols in record screens 98 specifications BOTETE eera e E 150 PONI 2 v4sedoasoteeeeronesoneses 150 POO E E E ATE EE 148 SOOMS eana EA 120 Status screen 600 6 7 61 62 storage temperatures 148 150 stuck key advisory 0005 128 suggested bolus calculator2 13 30 34 93 169 examples emetic acwercssets 143 145 g
3. Bottom edges for blood sample Insert the top of the test strip into the test strip port Figure 7 3 on the next page until it stops This turns on the PDM and dis plays the code number on the screen Refer to page 57 to check Pod status and to Confirm ID 82 Checking Your Blood Glucose 7 on the PDM to match the code number on the lt a Always verify and be prepared to adjust the code p test strip vial Figure 7 4 The code number on the screen must match the code number on the side of your test strip vial They must always match or your results will be inaccurate See Set the blood glucose test strip code later in this chapter If you need to adjust the code number after the PDM has moved to the next screen just press the Up Down 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 control test 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 ie From some PDM screens you cannot access the Free 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 light Press the middle S
4. 26 Cancel an active temporary basal preset 0005 27 Change rename or delete a temporary basal preset 27 Maximum Basal Rate cece ese ce cece eee eeeeeeeeeenes 28 What is the maximum basal rate cc cece eee ees 28 Change the maximum basal rate ccc cece e ence e ee 28 Understanding and Delivering Bolus Doses 29 Whats a BOIUS cacnaneedosseeaniesacedeunser seme anicdagracaanes 29 Bolus DOSE O DUIONS sac Sccce ness ar eae N andes 30 Suggested Bolus Calculator 0 cece cence cece ee eeeeee 30 How a suggested bolus is calculated 0c eens 31 Deliver a Normal Bolus cece cece cece cee e cece eneneee 32 Deliver a bolus when suggested bolus calculator is On 32 Deliver a bolus manually suggested bolus calc is Off 34 Deliver an Extended BolUuS cc cccece cece cee eeeeeees 35 Deliver an extended bolus instead of a normal bolus 35 Cancel Active BOIUSES sisi ccdets coed adden ae ieaeec 36 Replace an Extended BoluS cece cece cece ee eeeeeenes 37 Bolus Presets a nccisreerwstaedunig oei a a 38 Create a DOIUS Preset e e A Ta EA aN 38 Enable an existing bolus preset c cece cece eens 39 Change rename or delete a bolus preset 04 39 Cancel an active bolus preset cece cece eee eee e eens 40 Car PhESEUS sian da rnins as E a Wee banan
5. Back Enter Back Confirm 4 Ifthe blood glucose reminders feature is turned On you can now set a blood glucose reminder 5 Press Confirm to begin the bolus delivery Figure 4 12 wore As a safety feature you cannot deliver two extended p boluses at the same time You can however cancel the first extended bolus and replace it with another see Replace an Extended Bolus on page 37 You can deliver a normal bolus while an extended bolus is being delivered Nore 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 correction bolus 1 unit meal bolus 1 unit Extend 3 units meal portion 3 units 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 To check the Pod status refer to page 57 for detailed instruc tions The ID screen must be confirmed before you can check Pod status An on screen message appears for as long as a normal bolus is being delivered Figure 4 13 on the next page 36 Understanding and Delivering Bolus Doses 4 a 3 00p 2 11 Bolus canceled A m 3 00p 2 11 Delivering bolus 1 00u deliv
6. 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 OmniPod System Start Date PDM Model UST400 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 7 days 800 591 3455 When calling from outside the United States 781 457 5098 Customer Care Fax 877 467 8538 Web site MyOmniPod com 2012 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 Third party trademarks used herein are the trademarks of their respective owners 14421 AW Rev C Contents INTFOQUCHION eessen aa aaa viii About This User Guide cece cece cece cece ceenceeneee viii SVMS EE beter aera ceraitactntes viii Conventions and TerMS ccc ce cece cece ceceeneneees Ix Important Information cece cece cece eee nent en enees ix INCICATION EE E E T E EE EE E T E ix Contraindicatii NS saredconnewhadomiseatsata anes amanemaesas moder X Your Role Safely Using the OmniPod System 04 xi
7. cece eee eee ee 69 70 Settings iccccndiactesiosceseseee 64 68 suggested bolus calculator 30 35 143 146 bolus presets 6 38 40 164 CANCE E ovens aaa EE E 40 CNCAC nt atte ciate etae 38 6 210 eee 39 enable oenen 39 FENAME 2 ccc cc cece cece eee ee eees 39 bolus reminder ACL tetris sane eer A A tetas bale 70 bolus reminders 000 ee 69 Bolus basal calcs menu 65 bright mode 0 eee 5 74 buttons Home Power ccceeeeeeeees 5 Up Down Controller 5 User Info Support 6 5 C 0 eae R 165 cancel DOUS 22 iste e 36 DOIUS DESE aecenas 40 one time temporary basal rate 25 temporary basal presets 27 CANN Aiicsancacedacaowenn tence 2 165 automated insertion 8 54 carb presets 6 2 40 42 165 CANO Cs eraitera a tabs sats 41 change category 60 41 al lt 7 ee nee 40 6 eN 42 CCIE EE E ENE envese neonate 41 42 LON ANG eien aE aiee 42 carbohydrate 006 1 165 COUNUING 2252 220sendiesoeted 2 165 MISTO a nenir eNEAN 103 carbohydrate bolus See meal bolus care and maintenance 138 cellular phones 0000ee 121 change basal programs eees 21 basal settings ee eens 64 bolus presets 0cc cece eee 39 bolus SettingS eee eee 64 Carb presetsS cc eee ee eee 41 tempor
8. Do not reuse this device single use only Caution Consult accompanying documents Refer to Instruction Manual Sterilized by ethylene oxide Manufacture date year month Lot number Expiration date use by date year month Reference reorder number Device serial number Type BF medical device protection from electrical shock Manufacturer Non pyrogenic fluid pathway only Not MRI safe Waterproof to 25 feet for up to 60 minutes Keep dry Storage temperature Do not use if package is damaged Rx ONLY Prescription home use IVD Personal Diabetes Manager Icons EI pramo g Tuono g a Cl a Up Down on color X Suspend cancel Q Text entry right 2 ie a Advisory alarm ft Home screen 151 Appendix OmniPod System Notice Concerning Interference AA SEDE isuli gaug The OmniPod Insulin Management System both the Pod and the Personal Diabetes Manager or PDM complies with Part 15 Apply blood sample of the FCC Rules Operation is subject to the following two Alert ae Blood glucose records conditions Q PDM lock Setup Wizard 1 These devices may not cause harmful interference 2 These devices must accept any interference received includ ame Battery 3 4 full Battery full ing interference that may cause undesirable operation m Battery 1 4 full E gt Battery half full Changes or modifications not expressly approved by Insulet could void the user s authority to operate the equipment HL
9. 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 A 3 Replace the battery door 4 Turn the PDM face up The PDM has begun to power on auto matically The 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 a list wore Initial settings are blank for target blood glucose 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 as you fine tune your OmniPod System To get started press Next on the Wizard s Welcome Screen to begin setting up your PDM It might be helpful to read each screen out loud as you proceed Enter your PDM ID 1 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 10 Getting Started 2 2 Press the
10. Drowsiness e 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 most 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 Ifketones 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 WARNING 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 119 9 Living with Diabetes Handling Special Situations Sick days Any physical stress can cause your blood glucose to rise and ill ness is a physical stress Your healthcare provider can help you make a plan for sick days The following are only gener
11. Test results below 70 mg dL mean low blood glucose hypo glycemia Test results greater than 250 mg dL mean high blood glu cose 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 reading and you have followed all instructions described in this User Guide call your healthcare provider immediately Blood circulation is different between the finger and other test sites like the upper arm and hand You may see differ ences in blood glucose measurements between the other test sites and your finger after eating taking insulin medica tion or exercise 96 Checking Your Blood Glucose 7 You may see changes in blood glucose in blood samples from the finger sooner than in blood samples from alternate sites Vigorous rubbing of the alternate test sites before lanc ing helps to minimize these differences Do not use during xylose absorption testing Measurements obtained from alternate site testing should not be used to calculate insulin doses with the OmniPod System The lancing device is for individual use only and must not be shared Always use a new sterile la
12. e Percentage of readings within the BG goal e Percentage of readings above the BG goal e Percentage of readings below the BG goal 101 8 Understanding Your Records In the List view press Event to select individual readings Readings with a question mark icon next to them have additional information available Figure 8 7 To see this infor mation 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 A 11 00p 2 11 A 11 00p 2 11 BG today BG reading was 7 56p 85 mo a manually entered 3 35p 95 mg dL 11 46a 90 mg dL ss Be aa 7 55a 150 mg dL Back Day Graph Close 4 Press Close to return to the List view 5 Press Graph to see a graph of the data Figure 8 9 View multiple day trends 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select A 11 00p 2 11 Py 11 00p 2 11 1 day n 7 today 90 day n 360 ams Avg Reads 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 6 100 k 12a 6a 12p 6p 12a Back List Back 7 day 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
13. 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 the function of medical electrical equipment Insulet Corporation declares that the OmniPod Insulin Manage ment System is in compliance with the essential requirements and other relevant provisions of Directive 1999 5 EC 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 System is used adjacent to other elec trical equipment if adjacent use is inevitable such as in work environments the System should be observed to verify normal operation in this setting The System communicates by low level RF energy As with all RF receivers the potential for disturbance exists even with equip ment that complies with FCC and CISPR emissions requirements The OmniPod System communicates with the following characteristics Frequency 433 Mhz FSK modulation with an effective radi ated power of 13mW The OmniPod System greatly exceeds the immunity require ments of the general standard for electromagnetic comp
14. ID screen Color cc eee e ee 11 OCS TOE E T 73 92 error messages BG meter 122 124 EXEYCISE 45 eusgichoxaseaenieens 115 120 expiration control solution 006 81 POG AA AEE ETE ET 68 test SDS 4055 0 Ee TEA 80 extended bolus 16 30 35 36 166 Extended option 0000 68 extreme temperatures 78 F failure See communication failure Tab E SE E EEEE E A A 166 MOCK P E EEEE EE 41 166 fill syringe 0 eee eee ee eee 47 49 Flow accuracy POG crecnchac ratestdaauteves ann 149 Flow rate CFrOr ee eee eee eee ees 149 food library See reference food library G GIUCAGON usred anen a 109 GI COSC a5 insna aer aaea ix 166 H hard Wolkera enneh 120 hazard alarm manual shut off 131 hazard alarms 125 131 167 healthcare provider xi 167 hemoglobin A1c HbA1c 167 HIPAA privacy notice 160 163 history ala M ane enea 103 Cll EE EE E est Siacyatuntols 104 Dasal ssw duaivclaeisceeuesatesecuaen 99 blood glucose 06 101 DOIUS essare euir started nua 100 carbohydrates 05 103 insulin delivery 4 98 99 Home screen 2 eee cece eee eee 6 7 Home Power button 64 5 hospitalization 0 e eee 121 hyperglycemia 106 115 118 167 AVOIGING si5shcaresensasasueeuee 116 CAUSES ontenan eea 117 118 SYMPTOMS aaao or nei 115 treating ci cscn
15. Up Down Controller Soft Keys Select Save Back Pressing and holding turns the PDM on and off When the PDM is on pressing this button quickly briefly displays the Home screen from which you can choose a menu item or view the Status screens shown later in this chapter Pressing and releasing 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 physi cal 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 cur rent screen you are viewing The User Info Sup port icon appears when additional information 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 Diabetes Manager Icons in the Appendix 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 e Let you identify your PDM e Tell you how the System is operating e List menu choices Explain
16. 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 WARNING A 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 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 78 Checking Your Blood Glucose The Built in FreeStyle Blood Glucose Meter With the FreeStyle blood glucose meter checking your blood glucose requires a very small sample size 0 3 microliters of blood Refer to your FreeStyle test strip instructions for use for impor tant test strip information You may want to test for low blood glucose When you feel symptoms such as weakness sweating nervousness headache or confusion When you have delayed a meal after taking insulin e When your healthcare provider advises you to do so WARNING WARNING Keep the system and the FreeStyle accessories away from young children as they contain small parts that may be dangerous if swallowed Only use FreeStyle test strips and FreeStyle control solution with the System Using other brands of test Strips and control solutions with the System can pro duce inaccurate results Never attempt to
17. Additional options let you customize how the PDM operates ID screen Identify your PDM by adding your name and choosing a color The options you set will be shown on the ID screen every time you turn on the PDM 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 Set it at the lowest setting to maximize battery life The ID screen must be confirmed before you can check Pod status Nore Press and hold the Power button to turn the screen back fe 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 To check the Pod status refer to page 57 for detailed instructions 73 6 Using the Personal Diabetes Manager 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 SP zoop zm r o t time interval that you set Set at the lowest setting to maximize Date time ID screen battery life
18. Change the site each time you apply a new Pod A new infusion site should be at least 1 away from the last site Using the same location repeatedly may reduce insulin absorption Do NOT apply the Pod within 2 of your navel or over a mole tattoo or scar where insulin absorption may be reduced gt p 50 Using the Pod 5 lt Front a lt Front Back _ gt 5 Using the Pod _ To help avoid condensation from occurring in the THP ie i viewing window make sure both your Pod and your insulin are at room temperature Prepare the infusion site WO You can reduce the risk of infection at the infusion site by follow X ing aseptic technique and disinfecting the infusion site Before Bs applying a new Pod always Tt 1 Wash hands with soap and water 5 2 Use soap to wash the infusion site Y of wore Antibacterial soap may irritate skin especially at the infusion site Ask your healthcare provider how to treat any skin irritation 2 Verify that the Pod is ready to be applied Pod is clean and dry 3 Dry the site with a clean towel 4 Use an alcohol prep swab to disinfect the infusion site Start at the center of the site and gently rub outward in a circular e Adhesive pad is intact and undamaged motion e Pod is intact and in its original condition 5 Let the site air dry thoroughly Do not blow on the site to Verify cannula does not extend dry it
19. If the total of the suggested bolus calculation correction bolus plus meal bolus is less than zero the suggested bolus dose is 0 00U The System will not suggest a bolus dose if your current blood glucose BG reading is below the minimum BG you have set for bolus calculation see Chapter 2 Getting Started and Chapter 6 Using the Personal Diabetes Manager The System suggests a correction bolus only when your BG reading is above the correction threshold or correct above value you have set see Chapter 2 Getting Started and Chapter 6 Using the Personal Diabetes Manager Meal IOB which is insulin on board from a previous meal bolus is subtracted first from the current correction bolus if any until it is Zero However any remaining meal IOB is never subtracted from the current meal bolus Correction IOB which is insulin on board active insulin from a previous correction bolus is then subtracted from the cur rent correction bolus if any remains until it is zero At that point any remaining correction IOB is subtracted from the current meal bolus The calculated insulin on board is rounded up to the nearest 0 05U A reverse correction only occurs if the meal bolus is greater than 0 00U If your blood glucose value is below the target blood glucose value and you have set reverse correction to On the sug gested correction bolus is subtracted from the suggested meal bolus If you have set reverse correction to Of
20. 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 a summer 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 23 3 Understanding and Adjusting Basal Rates You can set a temporary basal rate for a duration of 30 minutes to 12 hours Once the time limit is reached the Pod automatically returns to the active basal program Pod and PDM do not need to be close to each other 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 Off to 95 of your active rate as long as the temporary rate is less than or equal to your max basal rate Another limit on the temp basal rate when configured in
21. Pre meal Post meal Missed bolus Carb guess Basal evaluation start Basal evaluation stop Skipped meal OK Select Remove the lancet When you have finished testing remove the lancet from the lancing device Figure 7 31 Discard the used lancet properly in a puncture resistant container Then wash your hands with soap and water ig Lancing device depicted in Figures 7 31 is representative only Please follow the instructions included with your specific lancing device See Cleaning and disinfecting in the Appendix for instructions on how to clean or disinfect your PDM 92 Checking Your Blood Glucose 7 Blood Glucose Results and the Suggested Bolus Calculator If the suggested bolus calculator feature is turned On when you 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 nore Ifyou use the suggested bolus calculator within 10 ig 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 that BG value will be used automatically in the suggested bolus calculator process Figure 7 32 If the suggested bolus calculator feature is turned Off the Next soft key does not appear Instead Press Bolus to ope
22. above 50 F 10 C Storage temperature range 32 F to 86 F 0 C to 30 C Reservoir volume deliverable 200 units Cannula insertion depth 6 5mm Waterproof rating PX8 25 feet for up to 60 minutes Insulin concentration U 100 Alarm type Audible Operating relative humidity range 20 85 non condensing Storage relative humidity range 20 85 non condensing Operating atmospheric pressure 696 hPA to 1060 hPA Storage atmospheric pressure 696 hPA to 1060 hPA Non pyrogenic Fluid pathway only Type BF Medical device protection from electrical shock Flow Capability Basal Programmable by the user in 0 05U pulses up to 30 0 U per hour Bolus e Rate 1 5 units per minute e Range 0 05 to 30 0 units Delivery accuracy tested per IEC 60601 2 24 Basal 5 at rates gt 0 05 U hr Bolus 5 for all set values gt 0 05 units 148 Accuracy Test Results The following graph is designed to show flow accuracy of the Pod against given time periods 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 0 05 U h at high operating temperature The overall mean percentage flow error was 1 40 100 BQ 4 60 40 j NA EpMax 20 Tin T 3 al E i T a i a a ken e ea Error 3 E z0 B0 4 200 400 600 800 1600 L200
23. add new then press New 6 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 carb preset 1 carb preset 2 carb preset 3 7 Or to give a different name to the program d d 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 Press the middle Soft Key the right arrow to move the underscore to the next character Enter each character one at a time For example if you frequently eat a breakfast consisting of plain low fat yogurt with blueberries sweetener and cinnamon you might enter B u e space Y o g u r t Figure 4 20 on the next page Press Next 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 40 p p 9 Press Save to add the preset to the category If you do include grams of fiber in step 8 to the left the suggested bolus calculator uses carbs minus fiber Alter natively in step 7 you can enter the total grams of carbs ee EEEE minus the fiber yourself Your healthcare provider can Back Select Back Tag Edit best advise you on how to make this entry Understanding and Delivering Bo
24. 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 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 Ifyou 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 cans If you need emergency attention ask a friend or WARNING 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
25. lt r beyond adhesive backing once needle cap is removed Apply the new Pod F Prepare the Pod for applying to your infusion site 1 To remove the needle cap on the underside of the Pod place your thumb on the bottom flat edge of the needle cap and e If Pod is accidentally dropped discard it sterility may be pull it upwards Figure 5 15 The needle cap will snap off compromised 52 Using the Pod 5 e Ifyou are unsure the Pod is ready to be applied to the site press Discard and do not use it Figure 5 16 amp Figure 5 17 Select a new Pod Prepare infusion site Remove pod s needle cap If cannula sticks out as shown below press Discard x SS Discard Next 3 00p 2 11 Remove pod s adhesive backing If pod is wet or dirty or adhesive is folded press Discard If pod OK apply to site Back Discard Next wore Do not remove the needle cap until you are instructed to do so by the PDM When you remove the needle cap a drop of insulin may be visible at the end of the cannula or in the well Using the pull tabs remove and discard the white paper backing from the adhesive tape Figure 5 18 Apply the Pod to the prepared infusion site Press firmly to secure it to your skin F For the Pod to work best apply it a Crosswise or at a slight angle on your abdo men hip upper back or buttocks in Figure 5 19 on
26. ssesssnsensensee 73 D date and time 006 11 63 dawn phenomenon 165 deactivation See Pod deactivating delete basal program ece eee 23 bolus presets ccce cece eee 39 bolus reminder 00000 71 Carb presetS cc cece cece eee 42 temporary basal presets 28 diabetes diabetes mellitus 166 Diabetes Control and Complications Trial DCCT 4 2scesdvectcueeweenan 166 diabetes emergency kit 108 diabetes mellitus See diabetes diabetic ketoacidosis See DKA diagnostic functions 75 check alarmS 0ceceeeee 75 reset PDM rera respiren oR 75 disinfecting Wipes 06 139 DKA oreen r ENE 168 AVOICING cece cece cece ees 119 SYMPTOMS cot oicaieehanielond uae ate 119 TCALING eenen 119 duration of insulin action xi 15 31 143 144 166 E edit basal segment or rate 22 bolus reminder 006 70 Cal presets rioter 42 electrical interference 78 electrical safety 153 156 172 electromagnetic compatibility 153 156 electromagnetic fields 78 emergency kit 106 108 109 empty reservoir hazard alarm 127 enable basal program ee ees 20 bolus preset cece eee eens 39 one time temporary basal rate 24 temporary basal presets 26 enter
27. 1 Your New OmniPod Insulin Management System 1 Insulin Delivery with the OmniPod System 0eceeeee 1 How Does the OmniPod System Work ccceee ee eees 2 NO DINO 2 220 5aicneciuanedsaueacondddcuiua ers niasoees 8a 2 Suggested bolus calculation ccc cece cece eee e eens 2 Reference food library and carb presets 0ce cease 2 A fully integrated design with blood glucose monitoring 3 Record Keeping ssessessocsocsoesoesooesoessessoe 3 Personalizing your System cc cece cece eee ee cece eens 3 TAG POG aA Er wind aeascsanser AAEE 4 The Personal Diabetes Manager cecececeeeeeeeeees 4 Buttons that program and control the OmniPod System 5 PHimMaly screens eens rnet aAa EEEE TEDE 6 safety FEAtUNES recrea a a aa 8 Automatic priming safety checks and insertion 8 Occlusion detection 0 cc ccc cece eee cece eee eeeneeees 8 ACTS GNC alan S coco scaweai rrna Reco daw ates E Ae wade 8 2 Getting Started xii lawianiahcssakcciciweseew eis saseesevewsass 9 The OmniPod Starter Kit 0 cece ccc cece eee e eee eee 9 Set Up the Personal Diabetes Manager PDM 65 9 TNE Setpa erore r a eera ead aucnias Keaehatts 10 Enter your PONIND 22sec enced r E OS E 10 Select the ID screen COlOr 0 cece ccc cece cece eee e eee ees 11 SEU Cate ana ime isos ease TEA EE 11 Enter Dasal Setting Siarra kera r EE A 12 Enter blood glucose s
28. 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 Includes 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 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
29. 12 Have your communication needs met care that you do not understand 2 Use the equipment for the purpose for which it was pre scribed following instructions provided for use handling care safety and cleaning Supply Insulet Corporation with insurance information nec essary to obtain payment for services 4 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 Any change in your prescription or physician Any change or loss in insurance coverage oo Any change of address or telephone number whether permanent or temporary 158 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
30. 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 0 carbs 15 IC ratio 0 units Suggested bolus dose 1 correction 0 meal 2 IOB 0U Example 2 Current BG level 150 mg dL Carb intake 45 carbs Meal IOB 0 units Correction IOB 0 units Correction bolus 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 45 carbs 15 IC ratio 3 units Suggested bolus dose 1 correction 3 meal 0 IOB 4U 144 Appendix Example 3 Current BG level 100 mg dL Carb intake 45 carbs Meal IOB 1 unit Correction IOB 0 units Correction bolus 100 mg dL current 100 mg dL target 0 0 50 CF 0 units Meal bolus 45 carbs 15 IC ratio 3 units Suggested bolus dose 0 correction 3 meal 0 IOB 3U wore Meal IOB is never subtracted from another meal bolus only from a correction bolus Example 4 Current BG level 150 mg dL Carb intake 60 carbs Meal IOB 0 units Correction IOB 1 unit Correction bolus 150 mg dL current 100 mg dL target 50 50 50 CF 1 unit Meal bolus 60 carbs 15 IC ratio 4 units Suggested bolus dose 1 correction 4 meal 1 IOB 4U 145 Calculator guidelines When the suggested bolus calculator is turned On the OmniPod System applies these guidelines to the suggested bolus doses Suggested bolus doses are rounded down to the nearest 0 05U
31. 91 7 Checking Your Blood Glucose 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 screen Figure 7 29 on the previous page The time the test takes depends on your blood glucose level The higher your glucose level the longer it takes to get a result To mark the result as a pre or post meal test to indicate a level of exercise or to indicate other situations connected to this blood glucose reading press Tag Then a Use the Up Down Controller buttons to select a tag then press Select Figure 7 30 You can select a second tag for the reading in the same way 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 Manager b Press OK to return to the reading screen Figure 7 30 then press Next Ifyou do not want to mark the test press Next instead of Tag If the suggested bolus calculator feature is turned Off the Bolus soft key appears instead of Next ig 5 Remove the test strip If the strip port light was turned on it now turns off o 3 00p 2 11 Select BG tag Control
32. Alarms for instructions Once a Pod is activated and communicates with the PDM it can only receive commands from that PDM not from any other Suspend Insulin Delivery Sometimes you may need to briefly stop insulin delivery for 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 suspended ig p 1 On the Home screen use the Up Down Controller buttons to choose Suspend then press Select At any time during a suspension period press Resume to resume the basal program that is programmed for that time Extended boluses and temporary basal rates will be can celled when you suspend insulin delivery 2 Enter how long you want to stop all insulin delivery from 30 minutes to 2 hours in 30 minute increments Figure 5 27 on the next page then press Enter 3 Press Confirm to confirm that you want to halt all insulin delivery basal and bolus The PDM beeps and an on screen message lets you know that insulin delivery is indeed sus pended Figure 5 28 on the next page 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 on page 59 57 5 Using the Pod 4 Atthe end of the suspend ti
33. 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 8 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 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 2 Getting Started 4 Press Save to accept the target BG profile you have set To see e Press Confirm to accept the target BG profile you have set Figure 2 7 f When you have finished entering segments press Done the segments as a list press List To return to the graphic view press Graph a 3 00p 2 11 Save BG Target and Correct above segment Start 3 00p End 3 30a Duration 12 5 hr Target 110 mg dL Correct above 130 mg dL NOTE The correct above value is 20 mg dL higher than the target Back Confirm 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 a
34. Delivering Bolus Doses pi Bolus presets are available only when the suggested You can add what remained of the old extended NOTE bolus calculator feature is turned Off If the suggested bolus to the new one bolus calculator is turned On you can still use carb pre sets See Carb Presets on Page 40 B 3800p 2m Create a bolus preset Your old extended 1 On the Home screen use the Up Down Controller buttons bolus has been to choose Settings then press Select cancelled It had 0 75 u remaining to be 2 Choose Presets then press Select delivered over 0 52 3 Choose Bolus presets then press Select You may now continue 4 Choose add new then press New with your new bolus 5 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 Or to give a different name to the program Next a Press the Up Down Controller buttons to enter the char Bolus Presets acters that spell the name you want An up and down arrow symbol on the screen indicates which character Bolus presets are bolus amounts that you program for frequent you are changing use For example if you often take the same bolus at lunchtime you can create a bolus preset for that amount and name it b Press the middle Soft Key labeled with the right arrow to Lunch move the underscore to the next characte
35. 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 rate 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 00am_ 0 60 U hr Between 12 00 am midnight and 8 00 am the Pod delivers 0 60 units of insulin per hour 0 80 U hr Between 8 00 am and 3 00 pm the Pod delivers 0 80 units of insulin per hour 0 70 U hr Between 3 00 pm and 12 00 am midnight the Pod delivers 0 70 units of insulin per hour 8 00 am 3 00 pm 3 00 pm 12 00 am 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 you
36. OE SEN 75 Set the Screen time out sssssesrerererererererereee 75 Set the Backlight time out ccc cece cece eee eee eee 75 Set Diagnostic FUNCtIONS cece cece cence eee eeneenenes 75 DiagGhOSUC OPTONS eeren a se eetasecenens 76 Set a Reminder to Vibrate 0 cece cece cece eee e cece eees 77 Get the Most from Your PDM ccc ccc cece ee eeeeeenes 77 Keep it NANCY 3555 23 cdarenendaueds a a aah ens 77 Communicating with the Pod ccc cece cece cece ees 77 Water and your PDM cccc ccc ce cece eee eeeeeneeeee 77 Avoid extreme temperatures cece cece cece errereen 78 Electrical interference sorria erer ieren eens ee eneees 78 7 Checking Your Blood Glucose sssessossosssesseeso 79 The Built in FreeStyle Blood Glucose Meter 05 79 The FreeStyle Blood Glucose Test Strips 0 cece ee 80 Important test strip information cece eee eee ees 80 The FreeStyle Control SoOlUtion cece cece cece cece ees 80 When to perform a control solution test 008 81 Check that the meter and test strips are working 81 Control solution expiration date cece cece cece es 81 Ensure accurate control solution results 0000 81 Performing a Control Solution Test cece cece eee es 82 Performing a Blood Glucose Reading cceeeeeeeeee 85 Prepare the lancing devi
37. ShipmMent cece cece cee ee eee eeeeeeeneees 157 ITN CHUTIES anann rae eara ena interme NN 157 CHAP Accredited secretarei ieri a E E E 157 Customer s Bill of Rights and Responsibilities 158 Limited Warranty for the Personal Diabetes Manager 159 HIPAA Privacy Notice ccc cece cece ese eececeeteeeeeees 160 Uses and Disclosures of Medical Information 160 YOU RIGHTS tecatec aiduataoudd ious whe decades caewewennes 162 Our DUDES acs seine tons a tte nee LEET 163 What To Do If You Have a Problem or Question 163 GIOSSANY secin renie ka Seu eed elhee N a eae NS 164 aLe CE E E E E E E E E nes 170 vii Introduction About This User Guide Symbols Warning Describes potential serious adverse lt a reactions or indicates conditions that could cause death or serious injury Caution Caution Consult accompanying doc uments Note Provides helpful information Tip Offers a suggestion for successful use of the OmniPod Insulin Manage ment System NOTE iE This User Guide is intended for use only with PDM model UST400 To learn which version of the PDM you have turn it over On the back of the PDM look for UST400 If you see it this is the correct User Guide If you do not see UST400 on the back of the PDM please call Customer Care This User Guide is periodically updated Visit the Cus tomer Care
38. Using the Personal Diabetes Manager 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 2 Press 12 24 hr to choose either a 12 hour or 24 hour clock then press Enter Figure 6 4 Enter current time 1 36 p Back 12 24hr or 3 00p 2 11 Enter or 3 00p 2 11 Press Confirm to save time Time 1 36PM Note Setting the correct time is essential to ensure correct basal insulin delivery and BG records Cancel Confirm 3 Press Confirm to accept the new time Figure 6 5 wore Setting the correct time is essential to ensure correct basal insulin delivery and BG records Reset the date 1 Press the Up Down Controller buttons to choose the cur rent year then press Next 2 Choose the current month then press Next 3 Choose the current day then press Next 4 Choose the date format to be displayed by the PDM then press Select 5 Press Confirm to accept the new date and format A If you suspended insulin delivery to change the time or date remember to resume insulin deliv ery If you changed the time or date during the Pod change process remember to activate a new Pod Change Bolus and Basal Settings You and your healthcare provider entered initial bolus and basal System settings using the Setup Wizard Using the System setup menu you can edit all the OmniPod System
39. 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 ZN 3 00p 2 11 A 3 00p 2 11 Communication Communication error successful Last bolus command not received Refer to settings or history screens to review last action OK 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 again If the PDM still cannot send the instruction you will see Figure 11 7 again Follow step 2 134 Communication Failures 11 2 Press Discard The PDM will consider the Pod lost and ask whether you want to activate a new Pod ig If you have an unconfirmed correction bolus when you 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 Customer Care ZN 3 00p
40. 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 For the 7 14 and 30 day trends press Graph to see a graph of the trends Figure 8 11 on the next page Graphs are not available for 60 or 90 day trends Press Stats to return to the detail view ey 11 00p 2 11 F 11 00p_2 11 30 day n 30 Alarm history 300 2 11 12 3 02p Podexpired oa 2 9 12 6 00p Empty res ii i i HH KH 12a 6a 12p 6p 12a Back 7 day Stats Back 6 Press Back to return to the single day trends Alarm Records The PDM lists the entire alarm history for the OmniPod System The PDM can store over 90 days worth of alarm records 1 Onthe Home screen use the Up Down Controller buttons to choose My records then press Select Understanding Your Records 8 Choose Alarm history then press Select The PDM displays the date time and type of each alarm Figure 8 12 Press the Up Down Controller buttons to see additional screens Choose an alarm record then press User Info Support to see more information Carbohydrate Records The PDM displays the records of carbohydrates you have entered 1 2 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 displays the date t
41. ant 68 Ratios factors targets 66 Temp baSal cc cece cence 68 Options and settings 147 P POM oea ne roas n ERE 4 61 78 backlight time out 74 batteries cece eee eee 10 140 BG QOall x caseckosianedceroursebehen 72 blood glucose sound 73 CICANING cece cece eee ees 139 communication with Pod 132 137 CUSTOMIZE ics Midieodaneinsuriweous 73 75 disinfecting wipes 139 GFOPDCGcsctcwanscinesiheeotens 142 ICONS cxdieereshciweseaseuses 151 152 IDSE crac uae w coe e Enas 61 POMAOCKiuwiseicsusarassveawewwes 73 75 repair or replacement 126 screen time OUt 2 00 73 SCUUINGS endre etae eee 62 SE S TE E EE 9 specifications 0 ee 150 Status SCFE N eee e ee eee 61 62 SIOlAG GC ezeros rnrn adaa araa 138 submerged in water 77 EO a ETE TN E viii PDM error hazard alarm 130 PDM TOCK cisco tsnoincesaruteenuage 73 138 SO sos ses I AEA 75 PDM options System setup 74 personal contact information 104 Personal Diabetes Manager See PDM physical exertion 06 120 playing Sports e ewes 120 POO cdoca pace cieaand ance geen 4 44 60 APDIVING lt as042005neseSouwneedondee 52 change process 0e ees 44 check statusS ec eens 57 cleaning cece cece eee ees 138 deactivating ce cece 45 expiration
42. as caro tuto E ee ewes 138 Cleaning and disinfecting cece eee e cece eee eeees 139 Replacing BatterieS ccc cece cece cece eee a ah 140 If the PDM becomes submerged in water 068 141 VOU Crop the POM o peorisioroe nn aa 142 Storage and Supplies ccc cece cece ence ence ee enees 142 Suggested Bolus Calculator Examples and Guidelines 143 Meal bolus calculation ccc cece eee c een e eee neces 143 Insulin on board IOB calculation e cece ees 143 Calculator guidelines ccc cece cece cece ee eeeeeenes 146 OmniPod System Options and SettingS eee eee 147 Pod Specifications is csacsonncse new rinata erat deans 148 Accuracy TeSt ResUl oirett chalet sete uae teeemaoeeed ws 149 FION Tale ENOR sac iii ese AN 149 Personal Diabetes Manager Specifications 06 150 Blood Glucose Meter Specifications ce cece eee eeee 150 OmniPod System Label Symbols cc cece eee eeees 151 Personal Diabetes Manager ICONS 0cecececeeeeeee 151 OmniPod System Notice Concerning Interference 152 Electromagnetic Compatibility cece cece cece eens 153 Customer Bill of Rights ccc cece eee e cece eee ee ences 157 Mission Statement cece cece eee c eet ececeeseeaes 157 SCOPe Of SERVICES itz stcduwnst ceding eadieuatwheatervwceacs 157 COMPING ene a wend aA 157 Supply
43. basal settings TPLA see Chapter 3 Understanding and Adjusting Basal Rates and Chapter 4 Understanding and Deliver ing Bolus Doses Alerts and Reminders In addition to automatic safety alarms see Chapter 10 Alerts and Alarms the OmniPod System offers a number of personal set tings to help you manage your diabetes These features are optional You can turn them on or off at any time except for the alerts Those you can set at levels that you find convenient to remind you to change your Pod Notifications 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 30 minute increments Pod expiration Reminds you when the Pod is nearing the 72 hour expiration time Choose a period from 1 to 24 hours before expiration in 1 hour increments The default setting is 4 hours You will hear 2 sets of beeps every minute for 3 minutes The notification will repeat every 15 minutes until you press OK to acknowledge it 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 68 Using the Personal Diabetes Manager The Low reservoir alert wi
44. bolus and basal set tings as your needs change Check with your healthcare provider before making any changes 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose System setup then press Select 64 Using the Personal Diabetes Manager 6 3 Choose Bolus basal calcs then press Select 4 Choose one of the options Figure 6 6a and Figure 6 6b then press Select Each option is described below Bolus calcs Off Bolus calcs On Temp basal U hr Ratios factors targets Extended Units Temp basal U hr Bolus increment 0 05 u Extended Units Max bolus 8 00 u Bolus increment 0 05 u Max basal 1 50 u hr Max bolus 8 00 u Max basal 1 50 u hr 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 8 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 b 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 entr
45. device with the clear cap against the top of your test site 4 Press the release button Do not lift up continue to hold the button and gradually increase pressure against the site for several seconds Figure 7 23 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 Lancing device depicted in Figures 7 20 7 21 7 22 and 7 23 is representative only Please follow the instructions included with your specific lancing device 89 7 Checking Your Blood Glucose 6 Lift the lancing device straight up be careful not to smear the blood sample on your test site Measurements obtained from alternate site testing should not be used to calculate insulin doses with the OmniPod System Avoid lancing areas with obvious veins or moles to avoid excess bleeding Also avoid lancing areas where tendons or bones stick out for example hand bones 7 Ifyou see any signs of deterioration of the PDM i e cracking separation discolorations Please contact customer care Fill the blood glucose test strip with blood 1 Turn the PDM On using the Home Power button 2 Make sure that the strip is in the PDM and the PDM is pow ered on If the PDM has powered off take out the strip and reinsert it Figure 7 24 or simply press and hold the Power button to turn on the PDM Refer to page 57 to check Pod sta tus and to Confirm ID
46. diabetes with unprecedented freedom comfort convenience and ease The long term health benefits of better blood glucose control are well known Maintaining near normal blood glucose levels can help you live a longer healthier life with fewer diabetes related complications The OmniPod System also has many prac tical everyday benefits including convenience freedom flexibility and ease of use Continuous insulin delivery most closely mimics the insulin release of a 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 Continuous insulin delivery at preset rates eliminates the need for injections and the interruptions that come with them In addi tion with the OmniPod System insulin delivery can be changed with the press of a button to adapt to snacks or unexpected changes in daily routine The OmniPod System is a great option for people with diabetes who require insulin The OmniPod System works much like the pancreas of a person without diabetes by delivering insulin in two ways Asmall constant background supply of insulin called a basal rate is delivered automatically at a programmed rate all day and night An extra dose of insulin called a bolus can be delivered when you need it to match the carbohydrates in a meal or snack or to correct a high blood glucose
47. 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 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 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 rain bread and bran cereal Fiber is a type of carbohydrate but does not raise blood glucose levels as other carbohydrates do Food Library A 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 The items in the food library are derived from the USDA data base USDA National Nutrient Database for Standard Reference The Food Library is for reference only Food references contained in the library cannot be p
48. ey 11 00p 2 11 Jane Smith My info My info My info My info My info My info My info My info Back Edit Jane Smith 555 1234 v Back Save Enter each character one at a time For 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 105 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 Being actively involved in your treatment Checking your blood glucose levels frequently Washing your hands and disinfecting
49. healthcare provider s directions for how often to replace your Pod If you like you can set the Personal Diabetes Manager PDM to notify you when it is time to replace the Pod see Chapter 6 Using the Personal Diabetes Manager WARNING WARNINGS Do NOT apply or use a Pod if the sterile packaging is open or damaged or if the Pod has been dropped after removal from the package 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 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 or an alcohol prep swab 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 Verify there is no wetness or scent of insulin which may indicate the cannula has dis lodged 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 ris
50. how to perform certain tasks The System s primary screens are the ID screen Figure 1 3 the Status screen Figure 1 4 and the Home screen Figure 1 6 on the next page si 3400p 2 11 m 50 U 3 00p 2 11 PDMI ID Last BG 110 mg dL 12 47p today Last bolus 1 20u 12 47p today Jane Smith OB 0550 basal 1 0 70 Uhr Press Confirm if correct Ba OOOO ea Pod exp 10 44a 2 14 Confirm Home ID screen The System displays an ID screen to make the PDM easy to identify when you first turn it on You can personalize the ID screen by adding your name and choosing its color See for details on customizing your PDM You must acknowledge the ID screen before you can use the PDM It is important that you always identify the PDM as yours before you use it Status screen Lists the System s current operating status Figure 1 4 From top to bottom the Status screen displays e Current date and time e Battery life remaining Insulin remaining e Time date and result of last blood glucose checked or entered manually e Time date and total amount of last bolus delivered e Amount of Insulin on Board IOB will be displayed on Status screen if calculator in use 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
51. 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 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 The bolus calculator can be turned Off or On in the PDM Target blood glucose BG 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 is used to cover predictable short term changes in basal i
52. is that the rate cannot be decreased such that the resultant flow rate will be less than 0 05U hr Example if flow rate is 0 10U hr you can t create a temp basal decrease of 60 See the sections below on creating enabling cancelling and changing temporary basal presets Enable a one time temporary basal rate 1 Onthe 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 3 Choose Increase or Decrease your basal rate then press Next Figure 3 11 4 Enter the temporary basal rate depending on how you choose to show the rates or percent change then press Enter Figure 3 12 shows an example of a temporary basal increase In this example 25 MORE insulin will be delivered K 3 00p 2 11 K 3 00p 2 11 Would you like to increase or decrease your basic basal rate Enter temp basal increase Increase e a Decrease 25 y MORE basal insulin Back Next Back Enter wore During initial setup you and your healthcare provider either turned Off temporary basal rates or chose to show the rates as or U hr To change this setting see Chapter 6 Using the Personal Diabetes Manager 5 Enter the duration for the temporary rate then press Enter Figure 3 13 on the next page 24 U
53. middle Soft Key labeled with the right arrow to move the underscore to the next character 3 Enter each character one at a time For example if you want to enter your name you might enter J a n e space S m i t h A blank character or space is the first and last option in the scrolling menu 4 Press Next Select the ID screen color Use the Up Down Controller buttons to choose a color then press Next wore Your ID and the chosen color will be displayed on an ig identification ID screen that you must acknowledge every time you turn on the PDM Always be sure you properly identify your PDM before using it Set date and time 1 Use the Up Down Controller buttons to increase or decrease the time Press 12 24hr if you prefer a different time format Then press Next Figure 2 3 wore 12 Midnight 5 59 AM Night p 6 00 AM 11 59 AM Morning 12 Noon 5 59 PM Afternoon 6 00 PM 11 59 PM Evening On some screens the time may show as a for AM and p for PM O v e wN N Enter current time Evening 11 59 PM Back 12 24hr Next Enter the current year then press Next Choose the current month then press Next Enter the current day of the month then press Next Choose the date format you prefer then press Next Press Confirm to save the date and time settings Figure 2 4 on the next page 2 Getting Started K 3 00p 2 11 Sa
54. mul tiple patients Parts of the device are considered biohazardous and can potentially transmit infectious diseases even after you have performed cleaning and disinfection Ifyou are unable 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 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 This device is intended for self testing by the user Introduction If you are having symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide call your healthcare professional A Your Role Safely Using the OmniPod System Pump therapy requires substantial caregiver involvement especially among children Work with your healthcare provider to establish diabetes management guidelines and settings that best fit your or your child s needs These may include Insulin to Carbohydrate IC Ratio Number of grams of car bohydrate covered by one unit of insulin For example if your insulin to carbohydrate ratio is 1 15 then you
55. 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 or meal bolus Xi Introduction Your individual needs influence the initial settings you and your healthcare provider will enter into the Personal Diabetes Man ager PDM during setup see Chapter 2 Getting Started Your healthcare provider must help you enter these initial set tings Soon you will enter and change your own settings with confidence and ease The OmniPod System is more user friendly than most electronic devices you use every day In fact technol ogy is what makes the OmniPod System so easy to use 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 on the OmniPod System do not hesitate to talk with your health care provider For nonmedical emergencies or for
56. on or use the Personal Diabetes Manager PDM it establishes communication with the active Pod Usually com munication occurs quickly Occasionally communication takes longer and the PDM displays the communication icon during that time in the upper left hand corner of the current screen However if Communication does not work the PDM will walk you through the necessary steps to re establish communication Communication can fail if the PDM is Too far from the Pod The PDM and Pod should be side by side while priming during activation e Interrupted by outside interference See the OmniPod System Notice Concerning Interference in the Appendix ie As a Safety feature the communication distance be tween the Pod and PDM is reduced during activation Once a Pod is primed and communicates with the PDM the full communication range is restored and the Pod can receive commands only from that PDM Failure During Pod Activation or Operation When you send an instruction from the PDM such as Start to begin bolus delivery or Enable to begin using a different basal program the Pod usually responds quickly However if the PDM cannot send your instruction within a few seconds it dis plays the Communication error screen Figure 11 1 on the next page 1 Move the PDM closer to the Pod The PDM will try to commu nicate with the Pod again If communication still fails you will see the message in Figure 11 2 on the nex
57. or near water 108 Living with Diabetes 9 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 figuring 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 on page 108 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 e Insulin syringes or pens in case you need injections e Several vials of insulin or insulin cartridges if you use a pen e Glucagon kit Make sure any person you are traveling with knows how to give the injection e Alcohol prep swabs Written prescriptions for all medications and supplies Generic medications may be easier to find than brand names outside the U S When you travel outside
58. or other health related products and services that we provide Family Friends and Emergencies If you require emergency treatment and we are unable to obtain your consent we may disclose your Medical Infor mation 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 160 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 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 to a foreign government agency that is collaborat ing with the pub
59. reservoir hazard alarm when empty Continuous tone Pod has been deactivated Insulin deliv ery has stopped Press OK to acknowl edge Change Pod Check blood glucose Press OK to acknowledge AA The Low reservoir alert will 7 escalate to an Empty reservoir hazard alarm when insulin is depleted Be sure to respond to the alert when it first occurs This alarm occurs when the Pod s reservoir is out of insulin Press OK to acknowledge Change Pod Check blood glucose 127 10 Alerts and Alarms Mam pe Source Beaten acon Pod expiration advisory Advisory Pod 2 sets of beeps repeat periodically Press OK to acknowledge Change Pod now mae al Repeats every 15 minutes during Change Pod See Chapter 5 Using the the last hour of the Pod s lifeandis Pod independent of the Expiration noti fication that you can set See Chap ter 6 Using the PErsonal Diabetes Manager Escalates to Pod expired hazard alarm Pod expired Hazard Pod Continuous tone This alarm occurs when the Pod has Insulin delivery stopped Alarm reached the end of its operating life Press OK to acknowledge Change Pod now Change Pod Check blood glucose Stuck key detected Advisory PDM 2 sets of beeps every 5 minutes Check the key described on the screen Check Home button to Alarm In this example the stuck key is the resolve Home button Press the key to unstick it For technical support refer to your User Guide
60. safety at risk Reset PDM soft reset Restores all settings in the PDM to the factory defaults A Resetting the PDM deletes all basal programs temp basal presets carb presets bolus presets and all sug gested bolus settings Before you use this feature and delete these settings be sure you have a written record of the information you need History records will not be deleted As a safety feature you cannot reset the PDM when a Pod is active You must first deactivate the Pod p 15 6 Using the Personal Diabetes Manager Diagnostic 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 Diagnostics then press Select To check alarms 1 Choose Check alarms then press Select 2 Press OK The PDM beeps three times and vibrates three times If a Pod is active it beeps three times then sounds the alarm tone for 5 seconds Be sure to check the alarm function at every Pod change To reset the PDM 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 15 Press Confirm to reset the PDM If the Pod is still active you will be unable to reset the PDM Figure 6 16 Press OK to return to the Diagnostics menu or 300p 2 11 Press Confirm to reset PDM to factory default settings Thi
61. section of MyOmniPod com to see the most recent version and to find other helpful infor mation Users should wash hands thoroughly with soap and water after handling the meter lancing device or test strips Reminder Users should activate the PDM periodically to confirm that there are no alerts or alarms that require a response viii Introduction NOTE Screen displays shown in this User Guide are for illustrative purposes only and should not be considered suggestions for user settings Consult with your healthcare provider to determine the appropriate settings for you Conventions and Terms Bold Names of buttons soft keys menus and screens are in bold Words in italics are defined in the Italics Glossary at the end of this User Guide Press Press and release a button or soft key Hold Keep pressing a button until its function is complete Menu A list of options on the PDM Options allow you to perform tasks Screen Displays programming operating and alarm alert information Button A physical button on the PDM such as the Home Power button 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 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 a
62. 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 alphabetically and by category Your New OmniPod Insulin Management System 1 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 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
63. technical questions about your OmniPod System setup or operation you can call Customer Care 24 hours a day 7 days a week Customer Care 24 hours 7 days 800 591 3455 When calling from outside the United States 781 457 5098 Customer Care Fax 877 467 8538 Web site MyOmniPod com Your healthcare provider will give you all the tools and training you need to be successful with the OmniPod Insulin Manage ment System However in the end your success depends on YOU You must become actively involved in your own diabetes management to enjoy the outstanding control freedom and flexibility that is possible with the OmniPod System Being actively involved means e Frequently monitoring blood glucose levels e Learning how to operate your OmniPod System and practic ing proper techniques Visiting your healthcare provider WARNING Do NOT attempt to use the OmniPod Insulin Man agement System before you receive training from your healthcare provider Inadequate training could put your health and safety at risk Your New OmniPod Insulin Management System Insulin Delivery with the OmniPod System The OmniPod Insulin Management System is an innovative continuous insulin delivery system that provides all the proven benefits of continuous subcutaneous insulin infusion CSI therapy in a way no conventional insulin pump can The System s innova tive design and features allows you to live your life and manage your
64. that will be delivered is shown at the bottom of each Basal programs graph and list 10 To add the program to the PDM s memory press Save Repeat steps 1 through 9 above for each basal program up to 7 programs you want to create Enable an existing 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 20 Understanding and Adjusting Basal Rates 3 3 Choose the program you want from the list Figure 3 7 then press Enable es 3 00p 2 11 Basal programs basal 1 basal 2 Weekend ladd new Back Enable Select wore Adiamondicon appears next to the program that is active You cannot select the active program to enable it because it is already running 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 program is in pro cess see Temporary Basal Rates and Presets later in this chapter you must first cancel the active tempo rary basal program E 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
65. 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 A 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 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 Manager 138 Appendix Cleaning and disinfecting Cleaning is to keep free from dirt stains or impurities unsoiled Disinfecting is the process of destroying pathogenic organisms or rendering them inert Keep your PDM test strip port and USB port free of debris and liquids Dirt dust blood and control solution can impair the functionality of your PDM or damage it If the battery compartment becomes soiled gently shake out the debris or use a dry lint free cloth to remove it Do NOT use IV Prep wipes alcohol wipes soap detergent or solvents Never put any liquid into the battery compartment The PDM is NOT waterproof Do NOT immerse it or place it in or near water If the meter is being operated by a second person who is providing testing assistance to the user the meter should be disinfected prior to use by the second person Users should wash hands thoroughly w
66. the country or for long peri ods 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 Minimize airport security delays With changing airport security checks and screening procedures you may have questions on how this impacts traveling with your diabetes supplies Below you will find more information on prepping for travel and what you can expect when going through security checkpoints Travel Preparation e Review the TSA website for travel updates e Pack extra supplies and hypoglycemia treatments e Carry contact information for your physician Arrive at the airport 2 3 hours prior to your flight To ensure airport security checks run smoothly be sure you have the following items easily accessible e All diabetes supplies in your carry on luggage 109 Living with Diabetes e Asigned letter from your healthcare provider explaining you need to carry insulin supplies and OmniPod equip ment Prescriptions for all medications and supplies with origi nal prescription labels Screening Procedures The TSA offers the option of requesting a visual inspection of your medical supplies rather than putting them through the X ray This must be requested before the screening process begins Your medical supplies should be ready in a separate bag when you approach the Security Officer In order to prevent contamination or d
67. the next page b Up and down or at a slight angle on your upper arm or thigh in Figure 5 19 on the next page c Atleast one inch away from the last site 53 5 Using the Pod a OD LL wore The Pod s adhesive keeps it securely in place for up to p 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 5 After you securely apply the Pod press Next Figure 5 15 on page 52 amp 5 16 on page 53 The adhesive is designed for one time use Once removed a Pod cannot be reapplied Insert cannula and begin insulin delivery 1 To insert the soft cannula press Start Figure 5 20 a Ifyou are applying a Pod in a place that does not have a lot of fatty tissue or is very lean pinch the skin around the Pod Figure 5 21 after you press Start and hold it until the cannula inserts Occlusions may result in lean areas if you do not use this technique E The soft cannula is tinted light blue Press Start to insert cannula and begin basal 3 delivery Start 54 The Pod automatically inserts the soft cannula below your skin It takes a few seconds to complete this process Once the cannula is inserted the Pod delivers a prime bolus to fill the cannula with insul
68. the used Pod according to local waste disposal regulations 6 After removing the old Pod press Next 7 Press Yes to fill and activate a new Pod Figure 5 6 Check the infusion site for signs of infection See Avoid Infusion Site Infections later in this chapter 3 00p 2 11 Last BG 110 mg dL 9 04a today Last bolus 1 15u 8 44a today No active pod Would you like to activate a pod now 46 Using the Pod 5 Filla new Pod Before filling a Pod ensure that no other Pods are lt a being activated within 24 inches of your PDM Before filling a Pod with insulin ensure that the Pod is above 50 Fahrenheit 10 Celsius If the Pod has been exposed to temperatures below 50 F 10 C then allow the Pod to be brought back to room tem perature before filling it with insulin 1 Use an alcohol prep swab to clean the top of the insulin vial then discard the prep swab 2 Securely twist the fill needle onto the syringe Figure 5 7 3 Pull outward to remove the protective cap from the needle Figure 5 8 Save the cap you will need it later A Use care after removing the needle cap and exposing the fill needle Only use room temperature insulin when filling the Pod 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 heal
69. to any area of the skin with an active infection If you are unsure whether to use a specific site ask your healthcare provider e Atleast 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 e Beaware 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 Get the Most From Your Pod Avoid extreme temperatures The Pod s operating temperature is between 40 F and 98 6 F between 4 4 C and 37 C Under normal circumstances your body temperature will keep the Pod well within this range 59 5 Using the Pod Do NOT expose a Pod to direct sunlight for long peri 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 WARNING 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 re A Water and your Pod The Pod is waterproof up to a depth of 25 feet for up to 60 min utes IPX8 After exposur
70. to use another blood glucose meter you can enter the readings manually into the PDM 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 e Nameand save temporary basal presets e Add your own customized reminders e Enter your name phone number doctor s name and number and other emergency information 1 Your New OmniPod Insulin Management System The Personal Diabetes Manager All Pod operations are programmed and controlled through the Personal Diabetes Manager PDM Figure 1 2 The Pod The Pod Figure 1 1 is applied to your skin with an adhesive sim ilar to an adhesive bandage Top Bottom Viewing window Fill port Housing vent Adhesive backing Needle cap USB Port 3 BOOMs i More actions i Temp basal E My records aT Settings Suspend Test Strip Port User Info Support Up Down Controller Your New OmniPod Insulin Management System 1 Buttons that program and control the OmniPod System Home Power
71. with soap and water Do not leave any cream or lotion on the test Gray cap for testing on the site Thoroughly dry your hands and the test site 7 HAR g fingers Lancing device depicted in Figure 7 9 is representative only Please follow the instructions included with your specific lancing device 85 7 Checking Your Blood Glucose Prepare the lancing device 1 Snap off the cap on the lancing device at an angle Figure 7 10 4 Replace the cap until it snaps or clicks into place Figure 7 13 Be careful not to touch the exposed needle on the lancet Consult your lancing device instructions to ensure proper usage NOTE 2 Insert a new lancet firmly into the white lancet holder cup Figure 7 11 Pushing the device into the cup may cock the device which is fine 3 Hold the lancet firmly in place with one hand With your other hand twist off the rounded top Figure 7 12 Lancing device depicted in Figures 7 10 7 11 7 12 and 7 13 is representative only Please follow the instructions included with your specific lancing device 86 Checking Your Blood Glucose 7 5 Pull out the cocking handle until it clicks Figure 7 15 You may have already cocked the handle in step 2 This is okay You are now ready to perform a blood glucose test Insert the blood glucose test strip 1 Insert a new blood glucose test strip in
72. you have programmed into the PDM Check with your health care provider before using this feature or adjusting these settings If a suggested bolus exceeds the max bolus you have set the suggested bolus screen displays Exceeds max bolus Figure 4 1 on next page If you select Extend or Enter the following confirmation is displayed WARNING Exceeds max bolus of nn nn U Accept this bolus and temporarily override your limit Figure 4 2 on next page Consult your healthcare provider before changing the setting WARNING 30 Understanding and Delivering Bolus Doses 4 498 00p 2 11 Fan 3 00p 2 11 Suggested bolus 10 05 u WARNING Exceeds max adjusted for IOB bolus of 10 00u Carbs 123g BG 152 mg dL Accept this bolus and 10 05 temporarily override d hi your limit Exceeds max bolus Back Extend Enter Cancel Confirm 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 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 factors used to calculate a suggested bolus are e current BG e carbs entered e insulin on board IOB A suggested bolus can have a correction bolus only a meal bolus only or both Correction bolus The corr
73. your request in a reasonable amount of time Please contact our Privacy Officer if you have questions about requesting an amendment to your Medical Information 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 notifica tion purposes as described in this HIPAA Privacy Notice 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 Medical Information in violation of that restric tion unless it is needed to provide emergency treatment If you would like to request a restriction of the use 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 if you have questions about requesting a restric tion of the use of your Medical Information 162 You Have the Right to Request to Receive Confidential Comm
74. 1 16 showing how much insulin was delivered before the bolus was canceled b Press OK again to return to the Status screen A 3 00p 2 11 Communication timeout Bolus status unknown Press Ok to check pod status or press Discard to deactivate pod Discard OK a 3 00p 2 11 Bolus canceled 0 75u delivered ZA 300p 2 11 Communication successful OK 137 Appendix wore The OmniPod Insulin Management System has no user serviceable parts If you require assistance operating or maintaining the System please call Customer Care 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 waterproof 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 N 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
75. 1400 Observation Interval min 100 149 Appendix Personal Diabetes Manager Specifications Size 2 4 wide x 4 4 long x 0 98 high 6 21cm x 11 25cm x 2 5cm Weight with batteries 125 grams 4 41 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 4 4 C to 40 C Storage temperature range 20 2 F to 140 F 29 C to 60 C Operating relative humidity range 20 to 90 non condensing Storage relative humidity range 20 to 90 non condensing Operating atmospheric pressure 696 hPA to 1062 hPA Storage atmospheric pressure 703 hPA to 1062 hPA Communication distance At start up the PDM and pod should be adjacent and touching either in or out of tray to ensure proper communication during priming At least 60 152 40 cm during normal operation Alarm type Audible Alert type Audible and vibratory Warranty 4 Year Limited PDM Blood Glucose Meter Specifications Assay method Coulometric electrochemical sensor Calibration Plasma equivalent Hematocrit 15 to 65 Measurement units mg dL Result range 20 to 500 mg dL Sample Whole blood capillary Sample size 300 nanoliters 0 3 microliters Test time Results in as fast as 7 seconds 150 Appendix OmniPod System Label Symbols STEAILE DME EGG ore IPX8 4
76. 2 11 Due to a recent clock reset or unconfirmed bolus information bolus calculations cannot be used until 6 59p 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 3 00p 2 11 e Skip Or 3 00p 2 11 Last BG 193 mg dL 2 20p today Last bolus 1 30u 2 30p today IOB 1 20u Pod status not available Last status today 2 50p Pod exp 1 12p 2 14 Status Home 2 Press Skip to skip the communication process and immedi ately bring up Figure 11 10 135 11 Communication Failures At either Pod status not available screen press Home to return to the Home screen or press Status to send another status wore Ifthe Pod has expired you will see the screen in Figure 11 11 instead A 3 00p 2 11 Last BG 193 mg dL 2 20p today Last bolus 1 30u 2 30p today IOB 1 20u Pod status not available Last status today 2 50p Pod exp change pod Status Home request Failure During Bolus Cancellation 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
77. 3 00p 2 11 A 3 00p 2 11 Communication error Communication error Bolus status unknown Move to a new area and Cte then press Retry or VB press Discard to deactivate pod Move PDM close to pod Discard Retry 1 Move the PDM close to the Pod The PDM tries to communi cate with the Pod again 2 Ifthe PDM still cannot communicate with the Pod you will see the Bolus status unknown message Figure 11 13 136 Communication Failures 11 If your PDM is damaged or not working as WARNING expected call Customer Care for assistance Be sure to check your blood glucose frequently Remove your Pod and contact your healthcare provider for treatment guidelines to follow after you remove it 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 check the Pod status or press Discard to begin the deactivation process 4 lfat 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 1
78. 41 Appendix 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 2 4 Inspect the outside of the PDM for visible signs of damage Press and hold the Power button to see whether the PDM turns on and whether the LCD screen is damaged Inspect the inside of the battery compartment for visible signs of damage Do NOT use the PDM if it appears damaged or is not working as it should If you are unable to use your PDM to check your BG have a back up meter on hand to check your BG If your PDM is damaged or not working as it WARNING should please call Customer Care for assistance Be sure to check your blood glucose frequently Remove your Pod and contact your healthcare provider for treatment guidelines to follow after you remove it A If you require assistance please call Customer Care Storage and Supplies a 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 m 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
79. 55 from outside the United States 781 457 5098 We will respond immediately whenever possible some issues may take up to 14 days to resolve CHAP Accredited Insulet Corporation has been accredited by the Community Health Accreditation Program CHAP since 2007 To learn more about CHAP or to communicate concerns that you have been unable to resolve directly with the company please visit www chapinc org or call CHAP at 800 656 9656 157 Customer s Bill of Rights and Responsibilities You have the responsibility to 1 Ask questions about any part of the plan of service or plan of 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 Receive a timely response to your request for service Receive continued service Select the medical equipment supplier of your choice Make informed decisions regarding your care planning Understand what services will be provided to you oO DNDN FS 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
80. 64 airport SECUIIty cee ee eee 109 B BG reminder 0ee eens 68 alarmis fasnesrcsacssioedsauss 8 125 131 backlight time out 06000 74 Checking 0cce eee xi 79 97 acknowledg seeeee 125 a ne ee Eee 75 COG eiere EE E 82 88 ACAVISOLY cece eee eens 125 128 basal history sccscceeeeceueees 99 goal iMi aseacacimenmeewedewecmens 72 Nazad oecon Eh 125 131 basal program 12 17 23 164 MSTO eaei aaae 101 history records 103 104 add segment or rate 0068 22 levelere mes Gesiods 29 164 alert escalation 00000 125 BOD E ENTE 23 MONItOFING ec eee eee xi 3 alerts and reminders 68 71 E yayceeei geek nde tat 18 sounder oaeee 13 73 auto off alert ec cee eee 69 BN T E 23 EER S E E A E 88 90 170 LGSUSUIDiseccecesatendrwatadwacceks 87 blood glucose meter 3 79 97 164 error MessageS 122 124 redding S eserse dtc unieees 3 90 97 SENGS esee tn E eneieevaes 72 Specifications 0 eee 150 blood glucose readings enter manually 93 94 lowandhigh 95 96 DOUS sesati rne eeu 1 3 29 42 CANCE ESE E ea manees 36 GOSC ac euihenor E TE 29 164 extended ccce eee eee 30 35 MISCO errena 100 manual delivery 005 34 NOMMal EE EE 30 32 presets cece cece eee 38 40 164 ratios factors targets 66 EMINENS
81. Basal program a Battery empty Both the Pod and the PDM generate use and can radiate radio Lost history User Information frequency energy and may cause harmful interference to radio record Support communications There are no guarantees that interference will u n Blood Glucose Meter not occur in a particular installation If the OmniPod System does w Unconfirmed Temperature out of cause harmful interference to radio and television reception the history record range interference may be corrected by one of the following measures C Ea Spans Active Sela Move or relocate the OmniPod System idnight program or selecte history record BG tag Increase the distance between the OmniPod System and the other device that is emitting or receiving interference Insulet Corporation declares that the OmniPod System is in com pliance with the essential requirements and other relevant provisions of Directive 1999 5 EC This ISM device complies with Canadian ICES 003 and IC RSS 210 152 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 guarantee 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
82. Bolus basal calcs gt PDM lock Off s For extra brightness on the PDM screen press and ae Sem 4 Reg aoe rors hold the User Info Support button for 2 seconds mets a Baceignt Ea hens i i PDM options 10sec This enables a bright mode The screen will remain in this mode until the PDM times out or you turn it off Diagnostics To preserve battery life use this feature only when necessary Set PDM options Back Select Bak Select 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select 3 Press the middle Soft Key labeled with the right arrow to move the underscore to the next character 2 Choose System setup then press Select i 4 Enter each character one at a time For example if you want 3 Choose PDM options Figure 6 13 then press Select to enter your name you might enter J a n e space S m i t 4 Choose one of the options Figure 6 14 then press Select h A blank character or space is the first and last option in the scrolling menu Set ID screen 5 Press Save To change the ID As a safety feature an ID must be entered to enable 1 Choose ID then press Select the PDM to be identified 2 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 74 Using the Personal Diabetes Manager To change t
83. 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 Review the segment to ensure it is correct then press Confirm d When you have completed all time segments press Done then Save Reverse correction Choose On or Off then press Select Insulin action duration or Insulin on Board lIOB Use the Up Down Controller buttons to choose a duration of insulin action then press Enter 67 6 Using the Personal Diabetes Manager 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 Some settings have preset defaults but all settings TPE gt are changeable See the Appendix for a list of Sys tem specifications including preset default settings For additional details on bolus and
84. If this does not work call Customer Care 128 Na celle Vela Ga Ae Mam pe source Beeppanem don Occlusion detected Insulin delivery stopped Change Pod now Pod Error Insulin delivery stopped Change Pod now PDM Error Remove Pod now Call Customer Care 800 591 3455 Hazard Alarm Hazard Alarm Hazard Alarm Pod Continuous tone and PDM Pod Continuous tone PDM Continuous tone Press OK to acknowledge Change Pod Check blood glucose This alarm occurs when the Pod detects an unexpected error Press OK to acknowledge Change Pod Check blood glucose This alarm occurs if an unexpected error is detected in the PDM Press OK to acknowledge Remove Pod Call Customer Care immediately Check blood glucose 129 10 Alerts and Alarms A Sa ren n PDM Error Hazard Continuous tone This alarm occurs after the PDM is reset Memory corruption Alarm and amemory corruption error occurs Press OK to reset PDM Press OK to acknowledge and delete all user set Change Pod tings History records will not be deleted Check blood glucose System Error Hazard Pod Continuous tone This alarm occurs if an unexpected error Remove Pod now Alarm or is detected in the Pod or PDM Press OK Call Customer Care PDM to acknowledge 800 591 3455 Remove Pod Call Customer Care immediately Check blood glucose PDM Error Hazard PDM Continuous tone This alarm occurs after the PDM i
85. LACEMENT AS PROVIDED UNDERTHIS WARRANTY IS YOUR EXCLUSIVE REMEDY ANY APPLICABLE IMPLIED WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR 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 159 Appendix HIPAA Privacy Notice THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION IS USED AND DIS CLOSED AND HOW YOU CAN GET ACCESS TO IT PLEASE REVIEW IT CAREFULLY This notice
86. OmniPod System should NOT be used ina hyperbaric chamber as there is a potential for an explosion There are active electronics inside the Pod and PDM and a hyperbaric chamber has high con centrations of oxygen WARNING WARNING WARNING WARNING 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 NovoRapid Humalog or Apidra Novolog is compatible with the OmniPod System for use up to 72 hours 3 days 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 label ing and follow your healthcare provider s directions for how often to replace the Pod Not recommended for individuals with hearing loss Always verify ability to hear Pod PDM alerts and alarms The Pod and PDM may be affected by strong radi ation or 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 for Pod removal guidelines WARNING O WARNING WARNING 0 WARNING O The glucose meter and lancing device are for single patient use Do not share the device with anyone including other family members Do not use on
87. To view the segments of the basal program 1 Choose View then press Select Figure 3 8 21 3 Understanding and Adjusting Basal Rates Weekend Weekend Edt add new Rename 12 00a 8 00 060 Copy 8 00a 3 00p 0 80 Delete 3 00p 12 00a_ 0 70 Daily basal 16 70 u Done Select Back Edit To edit or adda segment or rate in the basal program 1 Choose Edit then press Select before editing an active basal program see Chapter 5 Using the Pod Remember to resume delivery after the edits are made ie As a Safety feature you must suspend insulin delivery 2 Choose the segment to change then press Edit Figure 3 9 Or choose add new then press New 3 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 5 Enter a basal rate for the new segment then press Enter 6 Review this new segment for accuracy then press Con firm 7 Tosave the newly entered segment into the basal program press Save Figure 3 10 If you want to make additional edits repeat steps 2 5 3 00p 2 11 Press Save to update Weekend 1 00 0 50 12a 6a 12p 6p 12a Daily basal 16 70 u Cancel Save List 8 To seethe program as a list press List To see the graph again press Graph 22 Understanding and Adjusting Basal Rates 3 To rename a basal program 1 After cho
88. 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 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 THIS WARRANTY DOES NOT APPLY IF THE PDM HAS BEEN changed or modified by any person or entity other than Insulet Corporation serviced or repaired by any person or entity other than Insulet Corporation 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 REP
89. a aadandeanianses 40 Create a carb preset cece r eee nee e cee eeeeeeeeeens 40 Change or edit a carb preset ccc cece cece eee e ee eees 41 Delete a carb preset ccc ccc cece ence eee eiee 42 Reference Food Library ceccececeececeeeeeeeeeeeens 42 Access the reference food library ecceceeee ee ees 42 5 Using the POG iiss ciscccieuseseusesestadeusdierielsteewseud 44 The Pod Change Process ccececece cece ee eeeeeeneeenes 44 Gather equipment and supplies c cece cece eens 45 Deactivate the current Pod cece cece cece cece enees 45 Fill MEW POO socreantrerectontiacens meson evens nitdialeanwrens 47 Select the infusion Site ce cece T ANEA 50 Prepare the infusion Site ccc cece cece cece e eee eens 52 Apply the new Pod ccccc eee cn NT 52 Insert cannula and begin insulin delivery 0 54 Check POG Statusin lt sccsscvtoasescniasoesacumanees ere EA 57 Suspend Insulin Delivery 0c ccc c eee c cence cece ee enes 57 Resume Insulin Delivery cc cece cece cece ence eeeneees 59 Avoid Infusion Site Infections cece cece cece eee eees 59 Get the Most From Your Pod cccececececeeeeeeencees 59 Avoid extreme temperatures cece cece cece cece eeees 59 Water and your Pod ccc ccc e cece en ececnceeeeeeeeees 60 Sale Stade shane a tics coeur a oe centre nnneeee
90. 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 your prior written authorization as described further below Uses and Disclosures of Your Medical Information Related to the Treat ment and Services Provided by Us Treatment Payment and Health Care Operations We may use your Medi cal 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 Infor mation 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 Appointment Reminder and Other Communications We may use or dis close your Medical Information without your prior written authorization to provide you or others with among other things i appointment remind ers ii product supply reorder notifications and or iii information about treatment alternatives
91. aan 60 Contents 6 Using the Personal Diabetes Manager sse00 61 THE ID See sidan aind dae veweis Gieea wee bar anoles N 61 The Status SCrEON aeeie wuss tae cancemeutowsuuead as avtucceowwes 61 Insulin gauge and display cece eee e cece eee eeees 62 POM SEMINO Sioen a A 62 The System Setup Menu cece cece cece ence e cece enenees 63 Reset the Date Or TIME ccc cece cece cence cece eeeeeeees 63 Reset THE TIME serienn a N 64 Reset the dale socere cece cece cece E E O aa 64 Change Bolus and Basal SettingS cccece cece ee eeee 64 BOIS CAS eane a ne a a EE a ASh 65 Ratios factors targets cece cece cece eee e ee ee ee eeeneees 66 lemp DASA ccisciiecnrnddeewasnwiassoiiasuataiidesLevAmuaeleas ets 68 Extended raa e a a E E E maniaee 68 BOIUS increment eruere eaae A E N 68 Max DOIUS rarnana rI ESTAN 68 Max DaSdl rales ecidae A EO saw 68 Alerts and Reminders 0 ccc aa a 68 Set alerts and reminders cece cece cece cece eeeeeeee 70 Change Blood Glucose Meter Settings ecee eens 72 Change BG goal limits cece c cece cece cece cece eee 72 Manage the blood glucose tags list cece eee ee 72 Change BG SOUN errereen 8s incase loonie mee EERUEO 73 Customize the Personal Diabetes Manager 06 73 Set POM ODtONS p 2ca Gedusnreteoeasauute new A i aan 74 Set ID SCION sh nis in a a a e a aaa 74 Set POMIOCK inoen nE AEE
92. activate the new Pod Figure 5 26 Press Discard to restart the process with a new Pod Check infusion site and ensure cannula is properly inserted A 3 00p 2 11 Press Discard to deactivate pod OK When you see the pink slide insert in this position it means that the cannula is inserted Figure 5 25 Back Discard NS 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 Slide insert Fink 56 Using the Pod 5 Check Pod Status To check Pod status if the PDM is turned Off press and hold the Power button to display the ID screen then press Confirm 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 but ton 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 insulin on board IOB and any alarm conditions See Chapter 6 Using the Personal Diabetes Manager for details of what you see on the Status screen p If the Pod goes into hazard alarm condition and the PDM is unable to communicate with it to turn off the alarm you can turn it off manually See the end of Chapter 10 Alerts and
93. al guidelines When you are ill check your blood glucose more often at least once every 2 hours to avoid DKA The symptoms of DKA are much like those of the flu Before assuming you have the flu check your blood glucose to rule out DKA see Diabetic ketoaci dosis DKA earlier in this chapter To handle sick days e Treat the underlying illness to promote faster recovery e Eat as normally as you can e Adjust bolus doses if necessary to match changes in meals and snacks e Always continue your basal insulin even if you are unable to eat Contact your healthcare provider for suggested basal rate adjustments during sick days Check your blood glucose every 2 hours and keep careful records of results Check for ketones when blood glucose is 250 mg dL or higher Follow your healthcare provider s guidelines for taking addi tional insulin on sick days Drink plenty of noncaffeinated fluids to prevent dehydration NOTE i e Call your healthcare provider immediately if you have If you are well enough to eat drink sugar free bever ages However if you are too sick to eat solid foods alternate between sugar free beverages and those containing sugar e Persistent nausea Vomiting for more than 2 hours High blood glucose or ketones that stay high even though you take extra insulin e Low blood glucose with nausea and vomiting Exercising playing sports or working hard Check your blood glu
94. alth 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 f3 3 00p 2 11 i 300p 2 11 Change pod Press Confirm to AddBGreading begin the pod change A process Assign Edit BG tags View food library This will deactivate your current pod Back Select Back Confirm 45 5 Using the Pod 4 Ifan extended bolus or temporary basal or both are actively running you will see a message similar to that shown in Figure 5 3 Press Confirm to accept the cancellation Or press Back to return to the More actions menu e 300p 2 11 Press Confirm to begin the pod change process This will deactivate your current pod Your temp basal will be cancelled Back Confirm 3 00p 2 11 Pod deactivated Remove and discard the pod and then press Next Next After you press Confirm you will see the message in Figure 5 4 To remove the old Pod a Gently lift the edges of the adhesive tape from your skin and remove the entire Pod Figure 5 5 Removing the Pod slowly will help to avoid possible skin irritation b Use soap and water to remove any adhesive that remains on the skin or if necessary use an adhesive remover c Discard
95. amage to your supplies the TSA states that you should be asked at the security checkpoint to display handle and repack your own supplies during the visual inspection process Any medication and or associated supplies that cannot be cleared visually must be sub mitted for X ray screening If you re concerned or uncomfortable about going through the walk through metal detector the TSA states that you should notify the Security Officer that you re wearing a pump and would like a full body pat down and a visual inspection of your pump instead You should also advise the Security Officer that the insu lin pump cannot be removed because it is inserted with a catheter needle under the skin Visit the TSA Contact Center if you have any further questions or concerns If the security detector goes off tell the security screener that you have diabetes and wear an insulin Pod pump wore Pods and PDMS can safely pass through airport X ray machines see the OmniPod System Notice Keep supplies accessible Concerning Interference in the Appendix On airplanes and trains keep these items with you rather than checking them e Personal Diabetes Manager PDM e An emergency kit e Vials of insulin cargo area temperatures may affect insulin e A copy of your healthcare provider s letter see Minimize air port security delays e Prescriptions for insulin and supplies Snacks in case food is not available Bottled wat
96. 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 accounting of the disclosures of your Medical Information 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 u
97. arb IC ratio Correction sensitivity Reverse correction Duration of insulin action Bolus increment Maximum bolus size Extended bolus On or Off Default is On On or Off Default is On 8 time segments 70 to 200 mg dL in 1 mg dL increments 50 to 70 mg dL in 1 mg dL incre ments Default is 70 mg dL 8 time segments 1 to 150g carb U in 1g carb U increments 8 time segments 1 to 300 mg dL in 1 mg dL increments On or Off Default is On 2 to 6 hours in 30 minute incre ments 0 05 0 1 0 5 or 1 0 units Default is 0 1 units 30 units Default is 10 units Units or Off 30 minutes to 8 hours in 30 minute increments Default is Off 147 Appendix Bolus presets 7 Carbohydrate presets 36 Suspend 30 minutes to 2 hours Low reservoir volume 10 to 50 units in 5 unit increments indicator Default is 10 0 units Pod expiration alert 1 to 24 hours in 1 hour increments Default is 4 hours Auto off alert 1 to 24 hours or Off in 1 hour increments Default is Off PDM lock On or Off Default is Off History storage 5400 records 90 days Language English Pod Specifications Size 1 53 wide x 2 05 long x 0 57 high 3 9cm x 5 2cm x 1 45cm Weight without insulin 25 grams 0 88 oz Operating temperature range Pod operating environment of 40 F 98 6 F 4 4 C to 37 C Note The Pod temperature will equilibrate to 73 F 98 6 F 22 7 to 37 C when worn on the body Startup temperature
98. ary basal presets 27 user information 105 check alarMS cececeeeeees 75 check blood glucose 79 97 CICANING cnt cutivegeracavenee 138 139 171 clock 12 hour or 24 hour 0065 64 code number test strip vial 83 88 communication distance to Pod 77 150 Interruption 006 78 132 communication failure 132 137 bolus cancellation 136 Pod activation 005 132 Pod deactivation 134 Pod operation 006 132 request for status 135 complications of diabetes 1 165 confidence reminders 69 contact information 104 continuous subcutaneous insulin infusion CSII 0008 165 control solution 0e cee 80 expiration 0 ccc e eee e cece ees 81 FESUINS 2 55 oss ncostn aa 81 85 LOS AAE EA O E ates 82 85 copy basal program 45 23 correct above value See correction threshold correction bolus 31 143 165 correction factor 14 29 66 67 165 correction IOB 06 143 correction threshold 29 65 67 165 create basal program eceeeee 18 bolus preset 0cc eee eee 38 Carb PI Sets ca2 280 xesaeweeneeds 40 CSII See continuous subcutaneous insulin infusion CTS Ca estaa a e 121 custom reminders s 70 71 customize PDM
99. ase a bolus amount either 0 05 0 10 0 50 or 1 00 units of insulin then press Next 15 2 Getting Started 2 Choose the maximum bolus you can give at one time then press Next A Set extended bolus doses To set the units for an extended bolus dose choose for per cent of the total bolus or choose Units for units of insulin To turn off the extended bolus feature choose Off Then press Next The maximum bolus default is 10 units Check with your healthcare provider before adjusting these set tings Set low reservoir advisory 1 Choose the level of insulin in the reservoir at which the PDM should give you an alarm Choose from 10 to 50 units in 5 unit increments then press Next Set Pod expiration notification 1 Choose the number of hours before a Pod expires when the PDM should give you a notification then press Next The values are in 1 hour increments and range from 1 to 24 hours The default is 4 hours The PDM asks whether you want to activate a Pod e Press Yes if you are ready to activate a new Pod See Chapter 5 Using the Pod to learn how to activate a new Pod e Press No if you do not want to activate a Pod at this time The PDM displays the Home screen 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
100. ase you have severe hypoglycemia and become unconscious wore Periodically check the expiration date of your glucagon kit to make sure it has not expired Always carry medical identification emergency TIPE gt wallet card and wear an emergency medical neck lace or bracelet such as the Medic Alert tag See the end of the Appendix for address telephone and website 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 immediately Check it every 15 minutes while you are treating 112 lt a Even if you cannot check your blood glucose do NOT 1 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 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 Check blood glucose again after 15 minutes If blood glucose remains low
101. atibility IEC 60601 1 2 153 Appendix 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 System is suitable for use in all establishments including domestic Emissions Classification establishments The System is intended for use in the electromagnetic environment specified below You should observe these requirements in the use of the 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 6 kV 15 kV 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 154 Radiated RF 80 MHz 2 5 GHz 10V m Portable and mobile RF communications equipment should IEC 61000 4 3 be used no closer to any part of the System than the recom mended se
102. ay use or disclose Medical Information of individuals who are Armed Forces personnel i for activities deemed necessary by appropriate military command authorities ii for the purpose of a determination by the Department of Veterans Affairs of your eligibility for benefits or iii to for eign military authority if you are a member of that foreign military service We may also disclose your Medical Information to authorized federal offi cials for conducting national security and intelligence activities 161 Appendix 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 Required Uses and Disclosures Under the law we must make disclosures to you when required by the Office for Civil Rights U S 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 Informa tion 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 exe
103. ce cece cece cece eee eee eene 86 Insert the blood glucose test Strip cece eee eee ee 87 Set the blood glucose test strip COde cece cece eee 88 Lance your upper arm or hand ececeeceeeceeees 89 Fill the blood glucose test strip with blood 90 Remove the lancet ccceceeeecececeeeeeeeeeeeneees 92 Contents Blood Glucose Results and the Suggested Bolus Calut Ot Araire a raed whee a dials a ea 93 Entering Blood Glucose Readings Manually 93 Editing TAGS reoriou nae ai ean ee sacueaien EN 94 Low and High Blood Glucose ReadingdS 0ceeeeeeees 95 LOW TEACINGS se uns wales er E Sauk arts aeunmodeds 95 FIQGH TEACINGS eserse r E ees E r meses 96 Important Health Related Information 0c0eeeeee 96 Understanding Your Records essessoessessesooeso 98 Record KECDING x caso meser a a E eae aed 98 Special symbols in record screens cece cece eee eeee 98 Insulin Delivery Records cece ceececececeseeeeeeenees 99 View insulin delivery records c cece eee eceeecenes 99 Blood Glucose Records c ccc e cece ee eeececeeeeeeneee 101 View single day trends cece cece ence eeeeee ences 101 View multiple day trends cece cee ee cece eee eeneee 102 Alan RECOMS lt cccceneseetsrcniacoeoneunbacedeenneteasewens ees 103 Carbohydrate Records cececeeeeeecececeeeeeee
104. cose levels before during and after exercis ing playing sports or doing unusually hard physical labor The Pod s adhesive keeps it securely in place for up to 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 For some contact sports you may want to remove the Pod 120 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 times that coincide with a scheduled Pod replace ment TELA Ifyou 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 A The Pod and PDM may be affected by strong radia tion or 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 H Living with Diabetes 9 Surgery or hospitalization For scheduled surgeries or hospitalization you should tell th
105. d option or set the desired value then press Select or Enter For Bolus reminders e Use the Up Down Controller buttons to choose On or Off then press Select e Ifyou 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 Choose the bolus reminder you wish to edit then press Edit b Choose Edit then press Select c Enter a new start time then press Next d Enter anew end time then press Save 70 Using the Personal Diabetes Manager 6 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 reminders 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 names in numerical order such as alert 1 alert 2 alert 3 If you want to give a different name to the reminder 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 the right arrow to move the undersc
106. e 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 e The control solution test results should fall within the range printed on the test strip vial label wote The control solution range is a target range for con trol solution only It is not a target range for your blood glucose 81 7 Checking Your Blood Glucose If control solution results are out of this range REPEAT THE TEST 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 Code on test strip vial does not match code set in the PDM Malfunction of the System 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 2 3 The System may not be working properly Do not use the System to test your blood glucose Call Insulet s Customer Care 24 hours 7 days 800 591 3455 When calling from outside the United States 781 457 5098 Performing a Control Solution Test Turn the PDM On using the Home Power button Grasp the bottom of the test strip with the printed side facing up Figure 7 2 Top to insert into meter FreeStyle test strip B w
107. e 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 you pre pare for these situations Always carry medical identification and wear an emergency medical necklace or bracelet such as the Medic Alert tag 121 Alerts and 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 Refer to page 57 for detailed instructions The ID screen must be confirmed before you can check Pod status To make you aware of a serious or potentially serious condition the Sys tem 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 Blood Glucose Meter Alerts These alerts let you know about an error in the blood glucose meter test strip sample or results The PDM beeps and displays an error message number as in Figure 10 1 If you are having symptoms that are not consistent with your blood glucose test and you have followed all instructions described in this User Guide call your h
108. e display shows the adjustment that have been made to the default basal rate active or current 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 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 in 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 mondicon _ appears next to it Ifa bolus was cancelled only the amount delivered before cancellation is shown unit increments even though you may have pro wore The amount shown after cancellation may be
109. e 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 164 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 vegetables 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 di
110. e 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 First be sure to write down the BG value on a piece of paper 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 On the next screen review the BG value you entered to make sure it is correct then press Confirm 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 4 on the next page The Suggested Bolus screen appears Figure 4 5 on the next page 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 32 a 3 00p 2 11 Are you going to eat now Cancel No Yes vor In the Suggested Bolus screen Figure 4 5 adjusted for Insulin on Board IOB appears only when Insulin Understanding and Delivering Bolus Doses 4 4 o 3 00p 2 11 Suggested bolus 1 00 u BG 150 mg dL 1 00U Back Enter on Board IOB is a factor in the calculation FPL To view detailed informati
111. e to water rinse off the Pod with clean water and gently dry it with a towel Insulin degrades at high temperatures and will freeze near 32 F 0 C Follow the insulin manufac turer s instructions for use Do not expose your Pod to water at depths greater than 25 feet or for more than 60 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 Verify there is no wetness or scent of insulin which may indicate the cannula has dislodged WARNING The PDM is not waterproof Do not place it in or near water A 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 WARNING 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 or if the Pod has been dropped after removal from the package as this may increase the risk of infection or serious injury 60 Using the Personal Diabetes Manager The ID Screen When you first turn on the PDM it displays the identification ID screen Figure 6 1 which allows you to identify that the PDM is yours You can personalize the ID screen by adding your name and choosing its color You must acknowledge the ID screen before yo
112. e x of the Introduction for insulins approved for use in the OmniPod System Syringes for injecting insulin Instructions from your healthcare provider about how much insulin to inject if delivery from the Pod is interrupted Blood glucose test strips Ketone test strips Lancing device and lancets Glucose tablets or another fast acting source of carbohydrate Alcohol prep swabs A copy of the letter from your healthcare pro vider for airline security see Minimize airport security delays later in this chapter Phone numbers for your healthcare provider and or doctor in case of an emergency 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 TIPE gt plans for handling emergency situations including what to do if you cannot reach your healthcare provider Water and Your Pod The Pod is waterproof to a depth of 25 feet for up to 60 minutes IPX8 After the Pod gets wet rinse it off with clean water and dry it with a towel Do NOT expose your Pod to water at depths greater than 25 feet or for longer than 60 minutes Check the 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 N The Personal Diabetes Manager PDM is not water proof Do NOT place it in
113. ealthcare professional WARNING A m 3 00p 2 11 Meter Error 1 See user manual for further instructions Status 122 Alerts and Alarms 10 The following table explains what the message could mean and what you should do Meter Error 1 See user manual for further instructions Meter Error 2 See user manual for further instructions 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 headache or confusion follow the recommendations of your health care provider for treating hypoglycemia 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 If the control solution test does not work or the error persists call Customer Care Ifyou have symptoms such as thirst fatigue excess urination or blurry vision follow the recommendations of your healthcare pro vider for treating hyperglycemia Conducta control solution test using a new test strip If the results of the control
114. eat 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 Investigate possible cause for hypoglycemia to avoid similar problems in the future see Possible causes of hypoglycemia low blood glucose on the next page Living with Diabetes 9 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 WARNING b e o e 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 113 9 Living with Diabetes 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 givin
115. ection 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 Insulin on Board IOB the amount of insulin still working in your body from previous meal and correc tion boluses The amount of time the insulin remains on board or active depends on what you set for your duration of insulin action ig 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 Appendix The OmniPod System can only subtract insulin on board IOB from a suggested bolus when the current BG is known 31 4 Understanding and Delivering Bolus Doses Deliver a Normal Bolus A Deliver a bolus when suggested bolus calculator is On 1 After you check your blood glucose the PDM displays the results Figure 4 3 see the end of Chapter 7 Checking Your Nore Blood Glucose Press Next wore A blood glucose value is current for up to 10 minutes ig 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 gt m 3 00p 2 11 150 e Calibration code 16 Done Tag Next When your blood glucose result reads HIGH or LOW th
116. ed additional measures may be necessary such as reorienting or relocating the equipment 155 You can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communi cations equipment transmitters and the System as recommended below according to the maximum output power of the com munications 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 MHz to 2 5 GHz d 0 7 NP 0 01 0 12 0 035 0 070 0 1 0 37 0 11 0 22 1 1 17 0 35 0 7 10 3 70 1 11 2 21 100 11 7 3 5 7 0 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 struc tures objects and people 156 Appendix Customer Bill of Rights Mission Statement Insulet Corporation is dedicated to designing developing and distributing products that provide superior treatment options and lifelong health benefits for pe
117. ediate bolus the Pod will alarm at the conclusion of the bolus Table 1 Minimum Typical Maximum time time time 5 00 U Bolus 200 seconds 202 seconds 300 seconds 1 00 U hr basal 5 0 hr 80 hr Pod expiration 0 05 U hr basal WARNING 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 Confirm on ID screen alerts alarms do not show on PDM until after ID screen is confirmed See Chapter 6 Using the Personal Diabetes Manager for a description of notifications and how to set them See Chapter 10 Alerts and Alarms for a list of safety alarms built into the Omni Pod System and how to respond to them At very low flow rates checking your blood glucose frequently may give you an early indication of an occlusion refer to Chapter 9 page 115 Getting Started The OmniPod Starter Kit Your initial shipment contains everything you need to begin using the OmniPod System 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 System review this User Guide and complete the Pre Training section of OmniPod s online Interactive Training Pro gram found in the Customer Care section of MyOmniPod com If you have a basic understand
118. eees 103 PAINE COGS iesirea a eta aa cacoemment 104 User Information Support ccc cece cece eee ence eeees 104 Add or change user information 0cceceeeeeees 105 Living with Diabetes cccccccccccccccccccccceecs 106 Your Role Safely Using the OmniPod System 685 106 Daily Diabetes Management Activities cece wees 106 Check your blood glucose frequently 0 0eeees 107 Inspect the infusion site daily cece cece eee e eens 107 Prepare for EMEGCNCIES assurera enoa n Eren Rn 108 Water and Your Pod cc cece cece ete e cece en eneeeneeees 108 Traveling and Vacationing cc cece cece eee e eee eeeeens 109 Plan for changing time ZONES ccc cece cece ence ees 109 Take enough supplies cece cece cece eee e eee e ences 109 Minimize airport security delays cc cece eee e eee es 109 Keep supplies accessible ccc cece ccc e cece ee eeees 110 Avoid lows highs and DKA cec eee ce cece eeeeneeeee 111 General PreCautiOns ccc cece cece cece ence ee eeeeeeee 111 Hypoglycemia Low Blood Glucose ceceee eens 111 To avoid hypoglycemia low blood glucose 112 To treat hypoglycemia low blood glucose 112 Hyperglycemia high blood glucose ce eee ees 115 Diabetic ketoacidosis DKA ccc ce cece cece ene eeees 119 Handling Special Sit
119. egment defined 1 unit of insulin U hr or starting at midnight decreases BG by SS ee 12 00 AM to mg dL T Ore to mg dL C A OF to mg dL to mg dL to mg dL to ____ N Name Grams of to mg dL carbohydrate to o mg dL g carb g carb g carb carbo Name Units g carb U g carb U g carb U g carb U g carb U g carb U U aman OmniPod Ny Insulin Management System Insulet Corporation 9 Oak Park Drive Bedford MA 01730 USA 800 591 3455 781 457 5098 MyOmniPod com 2012 Insulet Corporation All rights reserved Printed in USA PDM imagery is for illustrative purposes only PDM screens may vary based on model or user settings Model UST400 14421 AW Rev C
120. en tempo rary basal preset is running 26 K 3 00p_ 2 11 Temp basal presets enter manually Aerobics 0 20 Uhr 2 0 hr Understanding and Adjusting Basal Rates 3 Back Select K 3 00p 2 11 Enter duration for temp basal Rate 0 05 u hr 05h Back Enter Cancel an active temporary basal preset On the Home screen use the Up Down Controller buttons to choose Suspend cancel then press Select Choose Cancel temp basal then press Select Press Confirm to cancel the actively running temporary 1 basal preset suspend If you suspend insulin delivery while a temp basal is running the temp basal will be cancelled when you 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 wore You cannot edit change or delete a temporary basal ig preset that is actively running To change a temporary basal preset 1 Choose Edit then press Select Figure 3 19 K 3 00p 2 11 Aerobics Rate 0 20 U hr Duration 2 0 hr Edit Rename Delete Done Select 27 3 Understanding and Adjusting Basal Rates 2 Enteranew rate or new percent change for the preset then press Next 3 Enter anew duration for the prese
121. er especially on planes to prevent dehydration The name and phone number of a physician at your final destination in case of emergency 110 Living with Diabetes 9 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 avoid potential problems by knowing the signs of hypoglycemia low blood glucose hyper glycemia 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 e 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 Customer Care 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 Symptoms of hypoglycemia Never ignore these symptoms Shakiness e Fatigue Unexplained sweating Cold clammy skin e Weakness e Blurred vis
122. ered p 1 50 u Cancel OK ig If the bolus has already been completely delivered the Delivering bolus message and Cancel do not appear but the Status screen does appear 2 Press Cancel The Pod beeps to confirm the bolus is cancelled An on screen message tells you how much insulin was delivered before you cancelled the bolus Figure 4 14 Press OK to return to the Status screen nore lf your suggested bolus contains both a correction bolus and a meal bolus the correction bolus is always delivered first Replace an Extended Bolus You can replace one extended bolus with another The System tells you how much of the first bolus has not yet been delivered 1 After you see your suggested bolus press Extend instead of Enter see Figure 4 9 on Page 35 Press Yes to cancel the active extended bolus Figure 4 15 Or press Back to return to the Suggested Meal Bolus screen A 3 00p 2 11 Press Confirm to cancel your old extended bolus right now a 300p 2 11 Extended bolus is currently active Would you like to cancel the old extended bolus before programming your new bolus Back Yes Back Confirm Press Confirm Figure 4 16 The screen displays the amount of the old extended bolus that has yet to be delivered Figure 4 17 on the next page Press Next to return to the Suggested Meal Bolus screen 37 4 Understanding and
123. ess Next after each entry not to enter them simply press Next repeatedly to ie These additional units are not required If you prefer skip 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 2 Choose Presets then press Select 3 Choose Carb presets then press Select 4 Choose the category of the preset you want to change then press Select 5 Choose the carb preset you want to delete then press Edit 6 Press Delete 7 Press Delete again to permanently delete the preset Reference Food Library The Food Library is for reference only Food refer ences contained in the library cannot be populated and used for calculations Remember to write down values from the food library on a piece of paper to use them in the suggested bolus calcu lator The OmniPod System includes a reference library of over 1 000 common food items The library shows each item s grams or car bohydrate fat protein and fiber values 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 presets for your favorite meals The items in the food library are derived from the USDA data base USDA National Nutrient Database for Standard Reference Access the reference food library 1 On the Home screen
124. etting Started 2 temporary basal rates in units per hour Or choose Off to turn off the temporary basal feature For details about setting tem porary basal s 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 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 Press Save to accept the BG goal A Check with your healthcare provider before adjust ing these settings Set the suggested bolus calculator To set the suggested bolus calculator feature choose On or Off then press Next If 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 NOTE 5 Enter target blood glucose value 1 Use the Up Down Controller button 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 wore Ifthe suggested bolus calculator is On a correction e bolus will be suggested only when your
125. 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 about 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 Weight loss or gain Consult your healthcare provider for guidance Menstrual cycle Pregnancy wore Check with your healthcare provider for guidance on any of the causes or suggested actions above 118 Living with Diabetes 9 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 If left untreated DKA can cause breathing difficulties WARNING shock coma and eventually death Symptoms of DKA e Nausea and vomiting e Abdominal pain e Dehydration Fruity smelling breath Dry skin or tongue
126. f the System will not subtract insulin from the suggested meal bolus dose If you manually increase or decrease the suggested bolus the following rules apply If you increase a suggested bolus the increase is applied to the meal bolus unless there is no meal bolus in which case it is applied to the correction bolus If you decrease a suggested bolus the decrease is applied to the meal bolus until it reaches zero then it is applied to the correction bolus If there is no meal bolus the decrease is applied to the correction bolus 146 Appendix OmniPod System Options and Settings Time Date Maximum basal rate Basal programs Basal rate segments Basal rate increment Temp basal presets Temp basal Blood glucose BG goal for BG history Blood glucose reminder 12 hour or 24 hour clock MM DD YY DD MM YY MM DD YY DD MM YY YY MM DD YY MM DD 30 U hr Default is 3 00 U hr 7 24 per program 0 05 units 7 Units or Off 30 minutes to 12 hours in 30 minute increments Default is Off Upper and lower limits 70 to 200 mg dL in 1 mg dL increments On or Off maximum of 4 active at any one time Created at time of bolus entry reminder can be set for 30 minutes to 4 hours after bolus is started in 30 minute increments Default is Off Blood glucose meter sound Suggested bolus calculator Target BG value and correction threshold Minimum BG allowed for use by the suggested bolus Insulin to c
127. f the location of the PDM However you still need the PDM to deliver a bolus change the basal rate 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 5 feet 1 5 meters of the Pod Water and your PDM A Do NOT use IV Prep wipes alcohol swabs soap detergent or solvents to clean the screen or any other part of the PDM The PDM is NOT waterproof Do NOT immerse it or place it in or near water 11 6 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 4 4 C or above 104 F 40 C Do not store or leave the PDM where it may be A N 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 WARNING 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
128. fference 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 50 mg 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 normal release of hormones that block insulin s effect 165 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
129. for instructions on going back to treatment by ever need to reset your PDM having these settings injections handy will make setup very easy arm pe soure Beppe acon End of insulin suspend Advisory Pod 2 sets of beeps every minute for 3 Press OK to resume insulin delivery at Press OK to resume basal Alarm and minutes programmed basal rate PDM l l rate delivery Repeats every 15 minutes until A Insulin delivery will not resume insulin delivery is resumed until you press OK If you do not press OK to resume insulin deli very you could develop hyper glycemia high blood glucose Auto off alert Advisory Pod 2 sets of beeps every minute for 15 Press OK to acknowledge Alarm and minutes PDM A The Auto off alert will escalate to Escalates to Auto off hazard alarm a hazard alarm if ignored and if not acknowledged within 15 will result in the deactivation of minutes your active Pod Be sure to respond to the alert when it OCCUTS 126 Alerts and Alarms 10 Mam pe soure Beeppanem O aon Auto off Remove Pod now Low reservoir Replace Pod soon This is based on the vol ume level you selected Empty reservoir Insulin delivery stopped Change Pod now Hazard Alarm Advisory Alarm Hazard Alarm Pod and PDM Pod and PDM Pod and PDM Continuous tone 2 sets of beeps every minute for 3 minutes Repeats every 60 minutes until acknowledged Escalates to Empty
130. g 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 Incorrect target blood glucose levels Incorrect correction factor sensitivity factor Incorrect insulin to carb IC 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 114 Living with Diabetes 9 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 during and after activity and treat as necessary note Effects of exercise can last several hours even a full day after activity ends Consult your healthcare provider about adjusting your basal 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 g
131. gested bolus calculator feature is turned Off Checking i mii the Bolus soft key appears instead of Next Missed bolus Carb guess Basal evaluation start zow Ifyou marka test as a control solution test by mistake Basal evaluation stop you can unmark it Press Tag select Control then Skipped meal press Clear i OK seet A Do not apply control solution to both edges of the test Strip 84 Checking Your Blood Glucose 7 9 Compare the control solution test result to the range printed 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 Insulet s Customer Care 24 hours 7 days 800 591 3455 When calling from outside the United States 781 Cocking handle 457 5098 10 Remove the test strip If the strip port light was turned on it now turns off Depth settings dial If you remove the test strip before this step you will still see the available soft keys Depth indicator window Release button wore Be Sure to discard used test strips You can only use test strips once Used test strips are considered bio hazardous material Clear cap for testing sites Performing a Blood Glucose Reading other than the finger Figure 7 9 shows the parts of the lancing device mm To ensure accurate results wash your hands and the Sy __s test site for example your upper arm
132. ght 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 19 wore Ifyou need to adjust the code number after the PDM ig has moved to the next screen just press the Up Down 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 lt a The code number on the screen must match the code number on the side of your test strip vial Fig ure 7 4 They must always match or your results will be inaccurate 1 To stimulate blood flow keep your hand warm or lower your hand to waist level and gently massage your finger Checking Your Blood Glucose 7 2 Set the depth setting on the lancing device Figure 7 20 3 Lightly touch the lancing device with the cap against the side of your fingertip Figure 7 21 4 Press the release button 5 Gently squeeze your finger if needed until a blood drop the size of a pinhead forms Lance your upper arm or hand 1 To bring fresh blood to the surface of the test site rub the site vigorously for a few seconds until you feel it getting warm 2 Setthe depth setting on the lancing device Figure 7 22 3 Hold the lancing
133. gs Suspend menu to suspend cancel or resume insulin delivery programs wore You can go to the Status screen at any time by pressing Status from the Home screen 1 Your New OmniPod Insulin Management System 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 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 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 5 Using the Pod A hazard alarm sounds when an average of 3 to 5 units of missed insulin occurs This table depicts occlusion detection for 3 differ ent situations when using U100 insulin Table 1 If an occlusion is cleared a volume of insulin could be released That volume would not exceed 3 9 U If an occlusion is detected during an imm
134. gure 6 12a followed by custom tags and then add new Figure 6 12b For more information about tagging BG readings see Chapter 7 Checking Your Blood Glucose 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 300p 2 11 v Pre bedtime Custom BG tags add new Done 3 00p 2 11 Configure the list of available BG tags v Ketones trace v Ketones small v Ketones moderate v Ketones large New 72 Using the Personal Diabetes Manager 6 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 check marked hidden ones will not be 2 To add 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 buttons to choose letters and numbers for a name followed by the middle Soft Key the right arrow 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 Customize the Personal Diabetes Manager
135. gure 6 8b The steps are the same whether you choose all settings or individual ones Back Edit Done 4 Correction factor You can edit existing time segments and add segments up to a total of 8 oT 3 00p 2 11 ar 300p 2 11 a To edit an existing correction factor time segment choose Review all settings Review all settings the segment then press Edit Use the Up Down Control Target BG Target BG ler buttons to choose a new start time end time and cor Min BG for calcs Min BG for calcs rection factor Press Next after each entry 70 mg dL 70 mg dL b To add a segment choose add new then press New IC ratio IC ratio Use the Up Down Controller buttons to choose a start Correction factor Correction factor time end time and correction factor Press Next after each entry c When you have completed all time segments press Done then Save Reverse correction On Insulin action 3 5 hr Insulin action 3 5 hr Back Select Reverse correction On Back Select 66 Using the Personal Diabetes Manager 6 Ratios factors targets option does not appear in the p When the suggested bolus calculator is turned Off the Bolus basal calcs menu 1 Target BG and correct above value You can edit existing segments and add segments up to a total of 8 a To edit an existing target BG time segment choose the segment then press Edit Use the Up Down Controller but
136. hat is still active in the body from a previ ous bolus dose In the OmniPod System insulin on board IOB is considered in two parts the Insulin on Board IOB from a previ ous correction bolus and the IOB from a previous meal bolus 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 Insulin on Board IOB to help prevent stacking of bolus doses which is a major cause of hypoglycemia Insulin reaction see hypoglycemia 167 Insulin to carbohydrate ratio IC 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 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 breath odor and rapid breathing lt a It is im
137. he ID screen color 1 Choose Screen color then press Select 2 Use the Up Down Controller buttons to choose a color then press Select Set PDM lock Choose On or Off then press Select A 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 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 then press Select When the screen dims turn it on again by pressing any button The PDM will ignore the usual command and re light the screen E The lowest setting will drain the battery the least 6 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 and vibrates then the Pod beeps This function cannot be executed unless insulin delivery is suspended WARNING If the PDM fails to beep immediately call Customer Care If a Pod is active and fails to beep change the Pod immediately see Chapter 5 Using the Pod Continuing to use the System in these situations may put your health and
138. highlight it and press Clear The soft key changes from Select to Clear when you highlight the tag 6 Press OK to return to the list of readings 7 If no BG readings have been entered into the PDM within the past 2 hours you will see the screen in Figure 7 35 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 Manager Low and High Blood Glucose Readings WARNING 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 then retest with a new test strip on your fingers If you still get a LOW Treat your low BG reading perform a control solution test to ensure your system is working
139. hyperglyce mia high blood glucose 116 Possible causes of hyperglycemia high blood glucose Expired insulin Insulin exposed to extreme temperatures Infusion site in or near a scar or mole Infected infusion site Dislodged cannula Deactivate and remove used Pod Apply a new Pod filled from a new vial of insulin 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 Living with Diabetes 9 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 117 9 Living with Diabetes High protein or high fat meal Less activity than normal Blood glucose value greater than 250 mg dL with ketones present before
140. i e cracking separation discolorations Please contact Customer Care 139 IR Port USB Port Battery Compartment Reverse Side Test Strip Port BG ae Replacing Batteries The PDM requires two 2 AAA alkaline batteries You can pur chase them at any grocery hardware or convenience store AAA alkaline batteries are the preferred battery to power the PDM Do not use any other type of batter ies 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 dam age 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 later in this Appendix for the various battery power levels and their respective icons The PDM automatically alerts you when its battery power gets low see Figure A 2 When you see the Low PDM battery alert press OK to turn off the alert Replace the batteries as soon as you Can Low PDM batteries Change batteries soon 140 Appendix vore When your PDM alerts you that battery power is getting low the PDM will maximize remaining battery life by Turning off your vibration alert if set e Disabling bright mode e Disabling the test strip port light Once the batteries are replaced these functions resume lf the batte
141. ime and grams of carbohydrate you have entered Figure 8 13 on the next page 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 buttons for dates 103 8 Understanding Your Records A 11 00p 2 11 A 11 00p 2 11 Carb history today All history today 6 32p 36g 8 52a basal 0 05 u hr saa 9 8 52a Temp stopped bt g 8 50a bolus0 70u 47a 229 8 50aBG80mgdl 8 50a carb 17 g 8 49a basal temp 0 06 uhr 420 Back Event Back Event All Records The PDM displays the combined insulin delivery blood glucose alarm and carbohydrate records 1 Onthe Home screen use the Up Down Controller buttons to choose My records then press Select 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
142. in Figure 5 22 e 3 00p 2 11 02 3 00p 2 11 Pod is active basal 1 has been programmed Check infusion site and Please wait cannula a ls cannula properly inserted No Yes Once the soft cannula is inserted the PDM indicates that the Pod is active Figure 5 23 ie You will hear a click when the cannula inserts WARNING WARNING Using the Pod 5 Check the infusion site after insertion to ensure that the cannula was properly inserted The PDM will automatically remind you to check your blood glucose 1 5 hours after each Pod change Figure 5 24 on the next page If the cannula is not properly inserted hyperglycemia may result Verify there is no wetness or scent of insulin which may indicate the cannula has dis lodged 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 nore To help avoid condensation from occurring in the ie viewing window make sure both your Pod and your insulin are at room temperature Condensation may occur in the viewing window due to perspiration 55 5 Using the Pod 2 Press Yes if you can see that the cannula is properly inserted L J The PDM returns to the Status screen EA 300p 2m m Press No if you see a problem with the cannula The PDM Reminder Check BG instructs you to de
143. 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 100 Understanding Your Records 8 Blood Glucose Records The PDM stores blood glucose records for the past 90 days You Ma 1t00p 2 11 ia t1 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 12 53p 125 mg dL to choose My records then press Select Within goal 71 11 53a 105 mg dL Above goal 14 2 Choose BG history then press Select Below goal 14 The PDM displays the current day trends first Figure 8 5 mt including Back Trends List Back Event Graph Number of days and number of blood glucose readings n wore LOW and HIGH readings are included in the number Average blood glucose Avg BG i of BG readings n but not in calculations or averages e Lowest and highest blood glucose Min max e The BG goal you have set 3 Press List to see a list of the current day s readings Figure 8 6
144. in manufacturer s instructions for use and expiration date To order all OmniPod System products and supplies call Cus tomer Care 142 Appendix Suggested Bolus Calculator Examples and Guidelines A suggested bolus is equal to the sum of a correction bolus and meal bolus then adjusted for insulin on board if applicable 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 reduces meal bolus Meal bolus calculation Carbs entered insulin to carb IC ratio Example of meal bolus Carbs entered 45 grams of carb Insulin to carb ratio 15 45 carbs 15 IC ratio 3 units meal bolus Insulin on board IOB calculation Duration of insulin action time since your previous bolus duration of insulin action previous bolus IOB from a previous correction bolus is called correction IOB and IOB from a previou
145. 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 keto acidosis DKA See Avoid Lows Highs and DKA later in this chapter e 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 If you are unable to use the OmniPod Insulin Man cars 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 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 106 Living with Diabetes 9 Check your blood glucose frequently _____ i l If an infusion site shows signs of infection When you routinely check your blood glucose level you can iden E i i aa renove od and oonan tify and treat high or low blood glucose before it becomes a l y pp y problem see Avoid lows highs and DKA later in this chapter one at a different site see Chapter 5 Using the Pod Check your blood glucose BG 2 Contact your healthcare provider e Atleast 4 to 6 times a day when you wake up before every meal a
146. ing of the System in advance you will get more out of your training sessions After you unpack the Starter Kit use the Contents label on the sided of the box to make sure you have everything Then com plete 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 WARNING Prepare and keep an emergency kit with you at all times to quickly respond to any diabetes emergency For details see Chapter 9 Living with Diabetes NOTE E Set Up the Personal Diabetes Manager PDM Chapter 6 describes the PDM options in detail The instructions in this chapter are simplified to help you get started Turn on the PDM 1 Open the battery compartment on the back of the PDM by pushing the compartment latch and lifting upward Figure 2 1 on the next page No special tools are necessary 2 Getting Started 2 Insert two 2 new AAA alkaline batteries into the compart ment wore The diagram inside the compartment shows you which direction to insert the batteries Figure 2 2
147. ion or a headache Sudden hunger e Rapid heart rate e Confusion Tingling in the lips or tongue e Anxiety 111 9 Living with Diabetes WARNING 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 To avoid hypoglycemia low blood glucose G 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 Work with your healthcare provider to establish individual ized blood glucose targets and guidelines 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 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 c
148. ith soap and water after handling the meter lancing device or test strips Use the guidelines below to clean or disinfect your PDM The PDM can be cleaned and disinfected up to twice a week over the course of the life of the device 4 years The PDM should be cleaned and disinfected at least once a week In addition to cleaning and disinfecting once per week the device can with stand additional cleaning steps of up to 2 times per week over the 4 year use life 1 Be sure to turn off your PDM before cleaning or disinfecting 2 To clean and disinfect the outside surfaces of the PDM hous ing use Dispatch Hospital Cleaner Disinfectant Towels with Bleach EPA Reg No 56392 8 available online through major retailers 3 Following the instructions on the label of the Dispatch Hos pital Cleaner Disinfectant Towels with Bleach EPA Reg No 56392 8 wipe the outside surfaces of your PDM for at least one 1 minute Treated surfaces must remain wet for a full two 2 minutes sore While cleaning do NOT allow debris or liquid to get into E the test strip port USB port battery compartment or buttons see Figure A 1 on the next page 4 Let your PDM air dry completely before checking your BGnext We recommend you perform a control solution test to ensure the System functions properly See Performing a Control Solution Test in Chapter 7 Checking Your Blood Glucose 5 Ifyou see any signs of deterioration of the PDM
149. k of over infusion and possible hypoglycemia 44 Using the Pod 5 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 symptoms such as breathing difficul ties shock coma or death If insulin delivery is interrupted for any reason you may need to replace the missing insulin usu ally with an injection of rapid acting insulin Ask your health care provider for instructions on handling interrupted insulin delivery Gather equipment and supplies Gather the following before you begin e Avial of rapid acting U 100 insulin See the warning on page x of the Introduction for a list of insulin s approved for use in the OmniPod System cans NEVER use insulin that is cloudy it may be old or inac tive Failure to use rapid acting U 100 insulin or using insulin that is expired or inactive may lead to hyper glycemia or diabetic ketoacidosis DKA e Anunopened Pod e Analcohol prep swab a 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 he
150. level is below your target the System subtracts a correction amount from the meal portion of the bolus ie If the reverse correction feature is turned On and if System does not subtract anything for a blood glu ie If the reverse correction setting is turned Off the cose level below your target 4 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 5 Press Confirm to begin the bolus delivery Figure 4 8 below a 3 00p 2 11 Start bolus 1 40 u Back Confirm 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 2 Enter the number of units you want to deliver then press Enter 3 Ifthe blood glucose reminders feature is turned On you can now set a blood glucose reminder 4 Press Confirm to begin the bolus delivery 34 Understanding and Delivering Bolus Doses 4 p As a safety feature the OmniPod System only allows you to give a bolus at or below the maximum bolus dose you have set See Chapter 6 Using the Personal Oi sone ai B 00p_ 2M Diabetes Manager for information on resetting your Suggested bolus 5 00 u Enter amount of meal maximum bolus dose If suggested bolus calc is On Carb 60 g bolus to deliver now you can enter a temporary manual override to make BG 150 mg dL Meal 4 00
151. lic health authority Communicable Diseases We may disclose your Medical Information if authorized by law to a person who may have been exposed to a communi cable 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 over sight agency for activities authorized by law such as audits investigations and inspections Oversight agencies seeking this information include gov ernment 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 devi ations ii to track FDA regulated products iii to enable product recalls repairs or replacement or lookback including locating and notifying indi viduals who have received products that have been recalled withdrawn or are the subject of lookback or iv to conduct post marketing surveillance Appendix 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
152. ll escalate to an Empty res ervoir hazard alarm when insulin is depleted Be sure to respond to the alert when it occurs WARNING Auto off 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 Choose a time period from 1 to 24 hours in 1 hour increments or choose Off The default setting is Off Refer to page 57 to check Pod status and to Confirm ID WARNING The Auto off alert will escalate to a hazard alarm if ignored and will result in the deactivation of your active Pod Be sure to respond to the alert when it Occurs Turning the PDM on by inserting a blood glucose test strip does not send a Pod status to the PDM A This alert can be especially reassuring if you are prone to hypo glycemia unawareness Ask your healthcare provider about using this alert and where to set it gt Ifyou use the Auto off feature always turn on the PDM with the Power button before using the system This allows the PDM to obtain a Pod status Refer to page 57 to check Pod status and to Confirm ID 6 Bolus reminders Notifies 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 Program reminders Pod beeps when a program is in process see Chapter 3 Understanding and Adjusting Basal Rates and Chapte
153. lood glucose when it gets too high also known as a correction bolus This extra dose is in addition to the basal 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 current factors at the time you deliver the bolus Your blood glucose level e Your insulin to carbohydrate ratio e Your correction factor e Your target blood glucose e The amount of insulin on board IOB active insulin from pre vious meal and correction boluses e Your correction threshold correct above 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 N Check with your healthcare provider before adjust ing 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 Sys
154. lucose 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 m An occlusion 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 115 9 Living with Diabetes 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 If you feel nauseated or sick e Before driving a car e 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
155. lus Doses 4 These additional units are not required If you prefer not Change or edit a carb preset to enter them simply press Next repeatedly to skip 1 Onthe Home screen use the Up Down Controller buttons through the screens to choose Settings then press Select 2 Choose Presets then press Select 3 Choose Carb presets then press Select Ld 3 00p 2 11 4 Choose the category of the preset you want to change then Edit name press Select Figure 4 21 Blue Yogurt I 3 00p 2 11 Y 3 00p_ 2 11 Carb presets Favorites Favorites 8 Blue Yogurt Snacks Banana Meals add new Back Next 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 22 2 Choose a new category then press Select 41 4 Understanding and Delivering Bolus Doses 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 To rename 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 gives you the option to choose a blank space 4 Enter the grams of carbohydrate in the meal then press Next 5 Ifyou want enter the grams of fiber fat and protein in the meal and the total calories Pr
156. me a Pod Advisory alarm occurs Figure 5 28 menu item will read Suspend cancel instead and options for cancelling these programs also appear in the menu If these options appear choose Suspend insulin ie If a temporary basal or extended bolus is in process the delivery 300p 2 11 m 50 U 3 00p 2 11 Suspend insulin delivery LastBG 110 mg d 9 08a today Enter duration Last bolus 1 15u 8 44 today 1 0 rr lt INSULIN SUSPENDED Pod exp 11 16a 2 14 Home Back Enter End of insulin suspend Press Ok to resume basal rate delivery 5 To resume your programmed basal rate press OK Figure 5 29 note The Advisory alarm repeats every 15 minutes until you press OK Insulin delivery will not resume until you press OK If WARNING n you do not press OK to resume insulin delivery you could develop hyperglycemia high blood glucose 58 Using the Pod 5 Resume Insulin Delivery 1 On the Home screen use the Up Down Controller buttons to choose Resume Figure 5 30 then press Select f 9 3 00p 2 11 A Bolus E More actions gt amp Temp basal IS My records gt Status Select 2 Press Confirm to restart the basal program for that time seg ment Avoid Infusion Site Infections e Always wash your hands and use the aseptic technique to pre pare the infusion site before applying a Pod Do not apply a Pod
157. mmediately e When you think your test results are not accurate or if your after using it test results are not consistent with how you feel e When you drop or damage your PDM or expose it to liquids WARNING Use only FreeStyle control solution va the System Other brands of control solution may pro e When your healthcare provider advises you to do so duce inaccurate results with this System Check that the meter and test strips are working A control solution test follows the same procedure as a blood cars Do not use control solution past the expiration glucose reading except that you use a sample of control solution date or you may get inaccurate results instead of a drop of blood See Performing a Blood Glucose Reading later in this chapter Do not add water or any liquid to control solution When you perform a control solution test if the reading is within e Control solution tests are specified to be accurate only when the control solution acceptable range the meter is working performed between 59 and 104 F 15 and 40 C properly N Results from FreeStyle control solution tests do Control solution expiration date not reflect your blood glucose level 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 dat
158. n a screen where you can enter a bolus manually Or press Done to return to the Status screen to see the most recent BG result 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 Enter current BG 150 mg d Use for bolus calcs Back No Yes wore The Bolus Entry screen does not open if ie e A regular bolus is currently in process The meter temperature is out of range e You have tagged this BG reading as a Control The BG reading is less than your Min BG for calcs e Insulin is suspended Entering Blood Glucose Readings Manually You can enter blood glucose readings manually into the PDM This is particularly helpful if you use a separate blood glucose meter 93 7 Checking Your Blood Glucose 1 On the Home screen use the Up Down Controller buttons to choose More actions then press Select 2 Choose Add BG reading then press Select 3 Use the Up Down Controller buttons to enter the BG read ing from your separate meter To enter a LOW reading press the Up Down Controller buttons down until you reach the mini mum value 20 then press down one more time To enter a HIGH reading press up until you reach the maximum value 500 then press up one more time TIP 4 Press Tag to assign a tag to the
159. n end time for the segment then press Next d Enter the correction factor then press Next e On the next screen review the segment to ensure it is correct then press Confirm f To save the new correction factor segment press Done 3 To see 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 Getting Started 2 Set reverse correction 1 To set reverse correction use the Up Down Controller buttons to choose On or Off then press Next A If you enter carbs and reverse correction is 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 corrections 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 Enter the duration of insulin action 1 Use the Up Down Controller buttons to enter the duration of insulin action how long insulin lasts in your body then press Next wore The duration of insulin action setting is used to ig calculate the amount of insulin on board IOB from a previous correction bolus or meal bolus when you use the suggested bolus calculator Select bolus increment and enter maximum bolus 1 Choose a bolus increment how much each press of the Up Down Controller buttons will increase or decre
160. n existing basal segment then press Edit Or choose add new then press New v Enter a unique name Back Next OK l b Enter the start time for example 8 00 am then press d Press Next Next Basal segments are in 30 minute increments c Enter the end time for example 3 00 pm then press Next d Enter the rate for the new basal segment for example 0 80U hr then press Next 3 Understanding and Adjusting Basal Rates ig Basal rates outside the changed segment do not change H 300p 2 11 H 300p 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 80 3 00p 12 00a 0 70 nore Press and hold the Power button to turn the screen p 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 0 50 0 00 were using If it has been longer than 5 minutes the 12a 6a 12p 6p 12a PDM brings you to the Status screen Daily basal 16 70 u Daily basal 16 70 u Cancel Save List Cancel Save Graph 8 Review the graph of the new basal program Figure 3 5 9 To see the program as a list press List Figure 3 6 To see the graph again press Graph The total daily basal
161. ncet lancets are for single use only Objects that may be soiled with blood may then transmit pathogens See Cleaning and disinfecting in the Appendix for instructions on how to clean or disinfect your PDM FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Blood borne Pathogens Initial Communication 2010 http wwwfda gov MedicalDevices Safety AlertsandNotices ucm224025 htm CDC Clinical Reminder Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens 2010 http www cdc gov injectionsafety Fingerstick DevicesBGM html 97 Understanding Your Records Record Keeping Record keeping is an important part of successful diabetes man agement The Personal Diabetes Manager PDM helps simplify this task It automatically stores records of insulin delivery history blood glucose readings alarms and carbohydrates The PDM can store over 5 000 records or approximately 90 days worth of infor mation Once the memory is full new information begins to replace the oldest information N If the PDM batteries run out date and time are at risk Do NOT remove the old batteries until you have new ones on hand The PDM protects data in the mem ory for up to 2 hours after the batteries run out or are removed Special symbols in record screens In the record screens you may encounter several special symb
162. nd before going to bed 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 e Whenever you feel nauseated or sick Before driving a car Consider making infusion site checks a part of your Whenever your blood glucose has been running unusually TPL regular daily routine like showering or brushing your high or low teeth That way it s easy to remember Verify there is no wetness or scent of insulin which may indicate e Ifyou suspect that your blood glucose is high or low the cannula has dislodged e Before during and after exercise e Asdirected by your healthcare provider lt lt If you observe blood in the cannula check your blood f lucose more frequently to ensure insulin deliver Inspect the infusion site daily J TSA y At least once a day use the Pod s viewing window to inspect the infusion site Check the site for signs of infection such as pain swelling redness discharge or heat has not been affected If you experience unexpected elevated blood glucose levels change your Pod 107 9 Living with Diabetes Prepare for Emergencies 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 line A vial of rapid acting U 100 insulin See the warn ing on pag
163. nderstanding and Adjusting Basal Rates 3 6 Press Confirm to start the temporary basal rate shown on the screen Figure 3 14 in this example 25 more basal insulin will be delivered for 0 5 hours The Pod beeps to indicate that the temporary basal rate is running K 3 00p 2 11 K 3 00p 2 11 Enter duration for temp Start temp basal basal increase increase 25 MORE basal insulin for 0 5 hr 0 5 hr Time Period 1 19a 1 49a Back Back Confirm Enter Cancel a one time temporary basal rate 1 On the Home screen use the Up Down Controller buttons to choose Suspend cancel then press Select Choose Cancel temp basal Figure 3 15 then press Select Press Confirm to cancel the temporary basal shown on the screen x 3 00p 2 11 Cancel temp basal Suspend insulin delivery Back Select Create a temporary basal preset 1 UU BR W N On the Home screen use the Up Down Controller buttons to choose Settings then press Select Choose Presets then press Select Choose Temp basal 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 temp basal 1 temp basal 2 temp basal 3 Or to give a different name to the program 25 3 Understanding and Adjusting Basal Rates a Pres
164. nsulin 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 169 Index A BG reminder 0eeeeeee 68 edit segment or rate 22 activate anew Pod 44 50 bolus reminders 068 69 Ghia DIG a4 cncdeaeneatinmedaebewwans 20 active insulin See insulin on board confidence reminders 69 rena E essers creena netan meses 23 add custom reminders 65 70 basal rate 1 12 17 28 164 basal segment or rate 22 low reservoir alert 16 68 temporary nas bck ssvendieaendennes 23 bolus reminder 0000 70 missed Dolus ec cence 69 basal segment 12 17 164 custom reminders 5 71 Pod expiration reminder 68 basal settings ccee eee ees 12 user information 105 program reminders 69 batteries ccc eens 10 98 140 AChHESIVE eee e eee ees 4 53 54 aseptic technique 59 164 BG fag assier See tag a BG result FOMOVES atonoa aE 46 automated cannula insertion 3 54 55 blood glucose advisory alarms 125 131 164 auto off alert ccc cece eee ees 69 BG GOdliisceshaebviesiad 13 72 1
165. od glucose See hypoglycemia low reservoir advisory 127 low reservoir alert 16 68 lows highs and DKA avoid 111 M manual shut off of hazard alarm 131 maximum basal rate 68 maximum bolus 6 15 68 meal bolus 31 143 146 168 meal IOB errores rinnen 144 Medic Alert tag 0eeee 121 medical electrical equipment 153 156 menu Bolus basal calcs e00 65 More actions 06 7 32 WIV TECOS 4 svdvseiesnntanakaeweoate 7 SENOS areren teaevweate 7 Suspend resuMe 2 0 e eens 7 System setup oie beieeeuvicassats 63 Temp baSal cc cece eens 7 microwave OVENS 0 cece eeees 78 Min BG for calcs 14 65 67 missed bolus reminder 69 70 More actions Menu 008 32 WIRTS ccraniaccu aineena aa 121 multiple daily injections MDIs 168 multiple day trends BG history 102 N normal bolus 08 30 32 O OECIUSION EEE 115 119 168 occlusion detected hazard alarm 129 OmniPod label symbols 151 OmniPod System eceeees 2 one time temporary basal rate 24 ETE A IEE E EE ET 25 enaDle asecunacdeenciordadesemaess 24 operating temperatures 78 148 150 174 options BOIS Cal S resorin rt tec 65 Extended cccececeeeeees 68 Max basal rate 0 eee 68 Wax DOS vind outiselstad
166. of privacy practices the HIPAA Privacy Notice describes how we may use and disclose your Medical Information to carry out treatment payment or health care operations and for other purposes that are permit ted 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 per mitted by law we will obtain your written authorization before using your Medical Information or disclosing it to any outside persons or organiza tions 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 pre viously issued authorization please send your request in writing along with a copy of the authorization being revoked to our Privacy Officer Ifa copy of the applicable authorization is not available please provide
167. oft Key labeled Light To turn the light off press Light again Wait for the PDM to display Apply a blood sample to the strip on the screen Figure 7 5 Apply a blood sample to the strip Calibration code 16 Light 83 7 Checking Your Blood Glucose 6 Gently touch only ONE EDGE of the test strip to the control If BG sound is set to On the PDM beeps twice The result solution Specifically apply the control solution to the test appears on the screen strip edge next to one of the dark colored half circles Figure 7 7 6 on the previous page If BG sound is set to On the PDM beeps when the test strip is full To mark the result as a control solution result rather than a blood glucose test a Press Tag b Use the Up Down Controller buttons to select Control Figure 7 8 then press Select You can select a second tag for the test result in the same way If you do not apply the sample within 10 seconds the strip port light turns off To turn it on again press Light The Checking screen appears while the sample is process ing Figure 7 7 The strip port light turns off when the sample You can select a maximum of 2 taos is accepted nom J 00p 3 300p 2 11 6 300p 2m c Press OK Select BG tag 8 Ifyou do not want to mark the test as a control solution test Control press Next instead of Tag pamm Pre meal Post wore Ifthe sug
168. ogram 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 Understanding and Adjusting Basal Rates 3 b Press the middle Soft Key labeled with the right arrow to wore Asa Safety feature the words Invalid basal program move the underscore to the next character 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 NAmE 5 Enter the rate in U hr for the first basal segment from 0 05 to T TP A ae the maximum you entered during setup then press Next Edit name Invalid basal program 6 On the next screen review the segment to ensure it is name correct then press Confirm Weekend 7 Review the list showing your new basal program To use the same basal rate for the entire 24 hour program press Done and continue with step 7 Or to add basal segments and rates for example a higher basal rate between 8 00 am and 3 00 pm a Choose a
169. ols Qa Records with a question mark symbol next to them have additional information available To see this information use the Up Down Controller buttons to highlight the record then press the User Info Support button to view details about that record The record for this item has been lost wore If the PDM can no longer communicate with an p 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 without getting a Status update any unconfirmed records will be lost If this occurs the PDM will not display insulin totals for any day containing lost records 98 Understanding Your Records 8 The record for this item is unconfirmed vore When you power on the PDM it will request a status iS 11 00p 2 11 iS 11 00p 2 11 update from the active Pod and then update the Insulin delivery Insulin totals today insulin history If the PDM does not receive a status BG history SOS Bolus 520 23 90 update from the Pod the PDM will update history alarm hi A cit i 0 a with unconfirmed records The next time the PDM wie ws Basal 48 h A z receives a status update it will update these records mere Total daily 46 20u istory C This insulin delivery item spans midnight The date given My info is the start date Insulin Delivery Records The PDM sto
170. on about the calcula 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 3 Ifyou are going to eat now a Press Yes Figure 4 4 enter the number of carbohydrates you are about to eat then press Enter b On the next screen review the BG and carb values to make sure they are correct and then press Confirm Figure 4 6 on the next page If you ve previously entered a carb preset then either 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 c Press Enter to accept the suggested bolus Figure 4 7 on the next page Or press the User Info Support button to view calcula tion information used for this suggested bolus Press Close to return to the Suggested Bolus screen then press Enter 33 4 Understanding and Delivering Bolus Doses amp 3 00p 2 11 fam 3 00p 2 11 Use these values for Suggested bolus 1 40 u bolus calculations Carb 18g BG 110 mg dL 140uU BG value 110mg dL Carb value 18g Back Confirm Back Enter your blood glucose
171. ople 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 toa 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 contact us between the hours of 8 30am and 6 00pm Eastern Time Monday through Friday at 1 800 591 34
172. opulated and used for calculations Glucose A simple sugar also known as dextrose used by the body for energy Without insulin the body cannot use glucose for energy 166 Hazard alarm Notification by the PDM and Pod 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 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 250 mg dL or higher Hypoglycemia low blood glucose A lower than normal level of glucose in the blood generally 70 mg 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 A place on the body where 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 IOB active insulin The amount of insulin t
173. or administrative tribunal to the extent such disclosure is expressly authorized in certain conditions in response to a subpoena discovery request or other lawful process Law Enforcement We may disclose Medical Information as long as appli cable 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 pur poses 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 nec essary 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 m
174. ore to the next character c Enter each character one at a time For example for a reminder to pick up a prescription you might enter R x Figure 6 10 A blank character or space is the first and last option in the scrolling menu Edit name Rx Back Next d Press Next e Enter the time of day for the reminder in 30 minute incre ments then press Next e Choose Daily One time only or Off then press Select wore Custom reminders will repeat every 15 minutes until acknowledged 71 6 Using the Personal Diabetes Manager Change Blood Glucose Meter Settings You can adjust blood glucose BG meter settings BG goal lower and upper limits for BG history e Manage BG tags list BGsound On or Off On the Home screen use the Up Down Controller buttons to choose Settings then press Select 2 Choose System setup then press Select Choose BG meter then press Select Choose the setting you want to change Figure 6 11 then press Select or 3 00p 2 11 BG goal 100 110 mg dL Manage BG tag list gt BG sound On Back Select Change BG goal limits To change the BG goal limits press Edit change either or both values then press Save 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 Fi
175. osing a program from the list choose Rename then press Select 2 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 2 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 underscore to the next character then press Next 3 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 the active basal program try this Copy the active program rename it make the changes save it then enable it TIPL 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 ie Temporary Basal Rates and Presets As a Safety feature you cannot delete the active basal program What is a temporary basal rate A temporary basal rate lets you adjust your basal rate for a pre determined period of time
176. ound setting and BG goal 13 Enter target blood glucose value cece cece ee eeee 13 Enter minimum BG allowed for use in bolus calculation 14 Enter insulin to carbohydrate ratio cc cece eee ees 14 Entercorrection facto suave tendaleranddhcaiauseswe 15 Set reverse correction ic ucenccaciesacesicdedoiiosasagdassadees 15 Enter the duration of insulin action c cee eee 15 Select bolus increment and enter maximum bolus 15 Set extended bolus doses 0 cece cee cee cece eee e eens 16 Set low reservoir advisory 0 cece cece ence cece eens 16 Set Pod expiration notification cc cece cece eee 16 3 Understanding and Adjusting Basal Rates 17 What Is a Basal Rate 0c ccc ccc cece eee cence eeeees 17 Contents 4 Personalized Basal Programs cccececeeececneneeeeee 17 Create a basal PrograM cece cece cece cece ee eeeenenes 18 Enable an existing basal program eceeeeeeeeees 20 Change rename copy or delete a basal program 21 Temporary Basal Rates and Presets 0ceceeeeeeeeees 23 What is a temporary basal rate ccc cece cece ees 23 Enable a one time temporary basal rate 000 24 Cancel a one time temporary basal rate 0e eee 25 Create a temporary basal preset cece cece cece ee 25 Enable an existing temporary basal preset
177. paration distance calculated from the equation applicable to the frequency of the transmitter as below Recommended separation distance d 1 17 VP 150 KHz to 80 MHz 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 struc tures objects and people 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 used exceeds the applicable RF compliance level above the equipment should be observed to verify normal operation If abnormal performance is observ
178. portant to rule out ketoacidosis when you WARNING 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 168 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 s blood glucose level
179. 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 39 4 Understanding and Delivering Bolus Doses Cancel an active bolus preset 1 3 Press and hold the Power button to turn on the PDM To check the Pod status refer to page 57 for detailed instruc tions The ID screen must be confirmed before you can check Pod status if it is not already on An on screen message appears as long as a bolus is being delivered Press Cancel The Pod beeps to confirm the bolus is cancelled An on screen message tells you how much insulin was delivered before you cancelled the bolus Press OK to return to the Status screen For more details see Cancel Active Boluses earlier in this chapter 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 carb amounts during the suggested bolus Carb Presets calculator process Create a carb preset 1 On the Home screen use the Up Down Controller buttons 2 to choose Settings then press Select Choose Presets then press Select 3 Choose Carb presets then press Select 4 Choose the category for this carb preset Favorites Snacks or Meals then press Select 5 Choose
180. properly If the system is working properly follow your health care provider s recommendation to treat hypoglycemia 95 7 Checking Your Blood Glucose 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 for ketones reading but have no symptoms of high blood glucose then retest with a new test strip on your fingers If you still get a HIGH Check for ketones reading perform a control solution test to ensure your system is working properly If the system is working properly follow your healthcare provider s recommendation to treat hyperglycemia wore 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 92 to edit tags see page 94 Important Health Related Information For additional information consult your test strip product infor mation sheet warnine WARNINGS Severe dehydration and excessive water loss may cause false falsely elevated results If you believe you are suffering from severe dehydration consult your healthcare provider imme diately
181. r 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 18 on the next page 38 Understanding and Delivering Bolus Doses 4 d Press Next 6 Enter the new bolus preset amount up to the maximum bolus you entered during setup then press Next a 3 00p 2 11 A 300p 2 11 Edit name Bolus presets ter manually Lunch enter manually x Lunch 2 20 u Back Next Back Select 7 Review the bolus preset name and amount then press Save to accept it Enable an existing bolus preset 1 On the Home screen use the Up Down Controller buttons to choose Bolus then press Select 2 Choose the bolus preset you want to use from the list Figure 4 19 then press Select 3 Press Enter to confirm the bolus preset amount or if neces sary use the Up Down Controller buttons to adjust the bolus amount 4 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 2 Choose Presets then press Select 3 Choose Bolus presets then press Select 4 Choose a preset from the list then press Edit 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
182. r 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 presets 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 A 1 On the Home screen use the Up Down Controller buttons to choose Settings then press Select Check with your healthcare provider before adjust ing these settings 2 Choose Basal programs Figure 3 1 then press Select Basal programs Presets System setup gt Vibration Back Select e 3 00p 2 11 Basal programs basal 1 add new Back New Choose add new Figure 3 2 then press New To use 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 pr
183. r 4 Understanding and Delivering Bolus Doses for details These include e Temporary basal in process e Extended bolus in process Choose On or Off The default setting is On Confidence reminders The Pod or PDM beeps in response to your instructions so you become familiar with the operation of the OmniPod System and feel confident that you are getting the insulin you need These notifications include e Bolus delivery started Bolus delivery completed Extended bolus started Extended bolus completed e Temporary basal rate started Temporary basal completed Choose On or Off The default setting is On 69 6 Using the Personal Diabetes Manager Custom reminders Displays text reminders that you enter at times that you select You can choose to receive a notification Daily One time only or Off You can change or delete these notifications at any time Set alerts and reminders 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 Alerts reminders then press Select 4 Choose the option you want to set Figure 6 9 then press Select BG reminder Off Expiration 4 hr Low reservoir 10 00 u Auto off Off Bolus reminders Off Program reminders On Confidence reminders On Custom reminders Back Select For all except Bolus reminders and Custom reminders choose the desire
184. rcise 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 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 Med ical 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 Infor mation 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
185. re 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 To save the ratio press Done To change the ratio select the segment you wish to change and press Edit You can define up to 8 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 Press Confirm to accept the IC ratio you have set f To save the new ratio press Done To see the ratios as a list press List To return to the graphic view press Graph Press Save to accept the ratios you have set 14 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 8 time segments To enter additional correction factors choose add new then a Press New b Enter a start time for the segment then press Next c Enter a
186. re performing Important Information A US Federal law restricts this device to sale by or on 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 from the finger The glucose measurements should not be used for the diagnosis of or screening for diabetes The PDM glucose meter is intended for single patient use and should not be shared Introduction Abbott FreeStyle test strips are used with the built in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger upper arm and palm Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly 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 e Testing on newborns e Testing arterial blood Diagnosing of or screening for diabetes mellitus The
187. reading Press OK when fin ished For an explanation of entering tags see page 92 5 Press Save to save the reading Or press Cancel to return to the More actions menu without saving the reading Editing Tags Within 2 hours of a blood glucose reading you can remove or change a tag or add one However you cannot alter a Control tag 1 On the Home screen use the Up Down Controller buttons to choose More actions then press Select 2 Choose Assign Edit BG tags then press Select 3 Use the Up Down Controller buttons to choose a reading then press Tag Figure 7 33 A User Info Support icon is shown to the right of any reading to which you have already assigned one or two tags Or press Done to return to the More actions menu 3 00p 2 11 Select a recent BG today 2 58p 97 mg dL 2 5 1p 95 mg dL Z Done Tag Use the Up Down Controller buttons to choose the first tag you want then press Select Figure 7 34 on the next page 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 94 Checking Your Blood Glucose 7 3 00p 2 11 amp 300p 2 11 Select BG tag No BG readings in the Pre meal past 2 hours Post meal Missed bolus Carb guess Basal evaluation start Basal evaluation stop Skipped meal Exercise light OK Select OK 5 To remove a selected tag
188. reminder 68 HNN o EE EA E E E 47 flow accuracy eee eee ee ees 149 flow rate error cece eee eee 149 inserting cannula 54 DOMINO ssesocetoreriteatanaivases ss 49 removal 0000 45 46 120 Safety CHECkKS ec eee ee 49 specifications e cee es 148 Storage enna se ese ee a 138 Pod error hazard alarm 129 Pod expiration advisory 128 Pod expired hazard alarm 128 Pod occlusion hazard alarm 129 prescriptions cece cece eee 110 TOV ravel stan onssneaasaieoes cess 109 prime DOS cx tees ie vencereckeen 55 168 priming automatic 68 8 program reminders 06 69 BLOE EEE EE caecmarnce cna 168 R radio interference 00 eee 78 rapid acting insulin 119 Ratios factors targets option 66 67 record keeping 3 98 105 record SCrE NS 2 eee eee eee 98 105 ALANIS etine erea 103 I E E E E E ES 104 blood glucose 008 101 carbohydrates 00 103 combined records 104 insulin delivery 0 eeee 99 personal contact information 104 special symbols 98 102 User Info Support 104 reference food library 2 42 166 remove aPod 45 46 120 rename basal program ee eens 23 bolus PreSets 3 scss ica scesaedetaces 39 custom reminders
189. res Back Select Back Bolus Basal e Basal rates including any rate changes and temporary basals The PDM displays a summary of today s information Bolus doses both normal and extended including total boluses delivered total basal amount deliv Dates times and how long insulin delivery was suspended ered and total daily dose delivered Figure 8 2 Press the and dates and times when it was resumed Up Down Controller buttons to view the summary for e Total daily doses basal plus boluses by date previous days Wherever you see the symbol press the User Info Support View insulin delivery records button to see additional information 1 On the Home screen use the Up Down Controller buttons 3 To review your basal history by day press Basal to choose My records then press Select The display shows the basal deliveries that have occurred for 2 Choose Insulin delivery then press Select Figure 8 1 the current day most recent first Figure 8 3 on the next page The active basal rate or program is indicated by a dia mondicon _ 99 8 Understanding Your Records Back Event Bolus is 11 00p 2 11 ey 11 00p 2 11 Basal history today Bolus history today 5 00p 1 00 U hr 2 37p 2 90u 2 00e 3 00p temp re Poe u a 37p 1 25u OER 11 36a 2 65u 1 00 2 43p 1 00 U hr 11 36a 1 40u 2 43p Pod activated Back Event Basal For a temporary basal program th
190. return to the continuous tone alarm and how to resolve it 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 following table Some advisory alarms are controlled by levels you set in the Settings screen One example is the level at which the Low reservoir volume alarm sounds Hazard Alarms Hazard alarms occur either when the Pod is in a very serious con dition or something is wrong with the PDM Follow the instructions in the message to fix the alarm situation For details see the following table WARNING 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 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 125 10 Alerts and Alarms If you ever need to return the PDM for repair or _ Use the form at the end of this User Guide to write i TIPE down all your settings from the Setup Wizard If you replacement contact your healthcare provider y g tup ay
191. ries run out date and time are at risk DO NOT remove the old batteries until you have new ones at hand The PDM protects date and time for up to 2 hours after the batteries run out or are removed To replace batteries 1 Open the battery compartment on the back of the PDM by pushing the compartment latch inward and then upward Figure A 3 on previous page No special tools are necessary 2 Insert 2 new AAA alkaline batteries into the compartment wore The diagram inside the compartment shows you which direction to insert the batteries 3 Replace the battery door 4 Turn the PDM face up The PDM powers on automatically The PDM is now ready to use Dispose of the old batteries in accordance with local waste disposal regulations 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 thoroughly dry N 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 it has thoroughly air dried 1
192. rips away from direct sunlight and heat red liquid that contains a fixed amount of glu cose and has two important uses The FreeStyle Control Solution Store test strips in their original vial only never transfer them l to another vial or any other container e To ensure that your meter and test strips are working together properly To practice testing without having to use your own blood e Never store individual test strips outside the vial Afterremoving a blood glucose test strip from the vial imme diately close the vial cap tightly e With clean dry hands you can gently touch the test strip any where when removing it from the vial or inserting it into the Three levels of control solution are available Low Normal and High For information on test strip port how to obtain control solution call Insulet s Customer Care 24 hours 7 days 800 591 Do not bend cut or alter blood glucose tests strips in any 3455 When calling from outside the United Way States 781 457 5098 a J5 5 apg v fs os i amp 80 Checking Your Blood Glucose 7 When to perform a control solution test on the bottle as well as the date to discard it and begin using a You should perform a control solution test new bottle e When you suspect that your meter or test strips are not work Ensure accurate control solution results ing properly e Replace the cap on the control solution bottle i
193. rom that PDM 13 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 please call Customer Care 14 The System performs a series of safety checks and automati cally primes the Pod Figure 5 12 on the next page Once complete the PDM beeps letting you know that the priming and safety checks were successful 49 5 Using the Pod a Priming 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 Once a Pod is activated and communicates with the PDM it can only receive commands from that PDM not from any other 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 next 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
194. s by writing to Insulet Corporation Attn Privacy Officer 9 Oak Park Drive Bedford MA 01730 Furthermore if you believe that Insulet has violated your privacy rights with respect to your Medical Information you have the right to file a com plaint in writing with our Privacy Officer or with the Office for Civil Rights U S Department of Health and Human Services at 200 Independence Ave nue S W Washington D C 20201 Effective Date August 11 2004 Revision Date April 1 2009 163 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 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 glucos
195. s meal bolus is called meal IOB Example of correction insulin on board IOB 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 correction IOB In other words one hour after your previous correction bolus you have received only 1 unit of insulin from it 2 units of insulin are still working to correct your BG This feature prevents deliver ing too much insulin when correcting a high BG 143 Appendix Example of meal insulin on board IOB Duration of insulin action 3 hours Time since previous meal bolus 2 hours Previous meal bolus 4 5 units 3 hours 2 hours 1 hour 1 hours 3 hours 1 3 1 3 4 5 units 1 5 units meal IOB In other words two hours after your previous meal bolus you have received 3 units of insulin from it 1 5 units of insulin are still working to cover your meal the correction bolus is only reduced until it becomes 0 A Meal IOB is only used to reduce a correction bolus and units Examples of suggested bolus calculations The examples below use these settings e Target BG 100 mg dL ICratio 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 Meal IOB 1 unit Correction insulin on board IOB 1 unit Correction bolus
196. s reset Press OK to reset clock Alarm indicating that the time and date must be reset Press OK to acknowledge Reset clock Check blood glucose 130 Na celle Vela Ga Ae Mam pe source Besparen don Pod deactivation required Hazard PDM Continuous tone This alarm occurs after a PDM error Press Ok to deactivate Alarm occurs that requires the user to reset the date and time Press OK to acknowl edge Change Pod Check blood glucose Manual Shut off of a Hazard Alarm 4 The Reset Button is located in the PDM s battery compart ment Figure 10 3 If you respond to a hazard alarm but the PDM cannot communi cate with the Pod to acknowledge or shut off the alarm you can Figure 10 2 Figure 10 3 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 10 2 on the bottom of the Pod The port can be found by peeling back the adhe sive pad from the bottom of the Pod at the square end The alarm shut off port is to the right of the fill port 3 Press the paper clip straight down into the manual alarm shut off port until the alarm stops and can no longer be heard Then discard the Pod according to local waste disposal regu l Button lations Manual alarm shut 131 Communication Failures The Communication Process When you turn
197. s 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 if you take an aerobics class two nights a week you might enter A e r o b i c s Figure 3 16 A blank character or space is the first and last option in the scrolling menu d Press Next K 3 00p 2 11 Edit name Aerobics Back Next Capitals and lowercase letters are considered the same ie For a percent change choose Increase or Decrease then press Next Enter the temporary basal rate or percent change then press Next Enter the duration of the temporary basal rate from 0 5 hours to 12 hours then press Next Review the temporary basal name rate or change and duration then press Save to accept it Enable an existing temporary basal preset 1 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 17 on the next page then press Select If you want change the duration for the temporary rate in half hour increments then press Enter Figure 3 18 on the next page Press Confirm to begin the temporary basal rate shown on the screen The Pod beeps to indicate that the chos
198. s will delete all user settings History records will not be deleted Back Confirm 3 00p 2 11 Cannot reset PDM while pod Is active OK Tipe Use the form at the end of this User Guide to write down all your settings from the Setup Wizard If you ever need to reset your PDM having these settings handy will make setup very easy 76 Using the Personal Diabetes Manager Set a Reminder to Vibrate For certain reminders you can choose vibration instead of beeps or vibration followed by beeps instead of only beeps If you acti vate it the PDM will vibrate for e Blood Glucose reminders e Missed Bolus reminders e Custom reminders e No active Pod reminders ig To change the type of notification 1 Use the Up Down Controller buttons to choose Settings then press Select The PDM cannot be set to vibrate for hazard or advisory alarms 2 Choose Vibration then press Select 3 Choose Vibrate Vibrate then beep or Off beep only then press Select Vibrate then beep means the PDM will repeat the reminder twice using vibration After that it uses beeps Or press Back to return to the Settings menu 6 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 o
199. sing the Personal Diabetes Manager 6 You and your healthcare provider entered initial System settings EEES using the Setup Wizard see Chapter 2 Getting Started After T z0 2m setup you can use the System setup menu to customize or Date time gt change those settings as described in this chapter Bolus basal calcs gt Alerts reminders gt Reset the Date or Time BG meter PDM options gt Occasionally you need to change date and time settings for Diagnostics gt example to adjust for daylight savings time or 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 Back Select 1 Suspend insulin delivery wore Ifyou are changing the Pod you can reset the date or The System Setup Menu p time without suspending by changing the date or time before activating the new Pod The System setup menu lets you personalize the settings that control the OmniPod System These include 2 On the Home screen use the Up Down Controller buttons l to choose Settings then press Select e Date and time e Bolus doses basal rates and bolus calculator settings 3 Choose System setup then press Select l 4 Choose Date time then press Select e Alerts and reminders l 5 Choose either Date or Time then press Edit e Blood glucose meter settings and tags e PDM options e Diagnostics 63 6
200. 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 123 10 Alerts and Alarms 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 If the control solution test does not work or the error persists call Customer Care 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 If the control solution tes
201. suspended e Time and date of when the Pod will expire wore Ifa Pod has not yet been activated during Pod changes p 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 Status support screen From the Status screen press the User Info Support button to see details about the current insulin on board IOB in your Your New OmniPod Insulin Management System 1 body Figure 1 5 See page 31 for additional information describing insulin on board IOB mm 300p 2 1 1 Insulin on board IOB Meal IOB 1 30u Correction IOB 0 15u Total IOB 145u Close it 9 3 00p 2 11 A Bolus More actions gt amp Temp basal I My records gt or Settings gt Suspend Status Select Home screen Lists all the major menus Figure 1 6 Bolus menu to deliver bolus doses 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 Settings menu to edit enter and name basal programs temp basal carbohydrate and bolus presets and to custom ize System settin
202. syringe at an angle into the fill port Do not use any other type of needle or filling device besides the syringe provided with each Pod 48 Using the Pod 5 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 ome NEVER use a Pod if you feel resistance when you N77 depress the plunger This condition can result in interrupted insulin delivery 10 Remove the needle from the insulin fill port The port is self sealing insulin will not leak after the needle is removed 11 Place the protective cap back on the needle and remove the needle from the syringe A Do not insert the fill syringe into the fill port more than once ome NEVER inject air into the fill port Doing so may TTY result in unintended or interrupted insulin delivery The fill syringe is intended for single use only and should be used only with the OmniPod System A 12 After you fill the Pod it will beep twice After hearing the beeps PDM and Pod should be adjacent and touching either in or out of tray to ensure proper communication during priming Figure 5 11 on the next page Press Next note As a safety feature the communication distance be tween the Pod and PDM is reduced during activation Once a Pod is primed and communicates with the PDM the full communication range is restored and the Pod can receive commands only f
203. t DUHOM sc sccdedensicetavens ends 5 104 ICOM aatuerait aaa wees seas 5 S E EEEE E ET 105 V VACATION ensa seus ehewveleeies 109 WwW WOANLY ccauleuuionie terete eaten 159 Watel ecsedi an 77 108 141 wireless communication technology 78 X DEVO Sania fetuses REE RE 110 121 177 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 Name 12 00 AM to to to to to to to Rate U hr U hr U hr U hr U hr U hr U hr Name 12 00 AM to to to to to to to Rate U hr U hr U hr U hr U hr U hr U hr Target BG for each time segment defined starting at midnight These values are used by the suggested bolus calculator 12 00 AM to to to to to to to to Target BG Suggest correction when BG is above mg dL mg dL mg dL mg dL mg dL mg dL mg dL mg dL Insulin to carbohydrate ratio for each time segment defined starting at midnight 12 00 AM to to to to to to to to 1 unit of insulin covers g carb g carb g carb g carb g carb g carb g carb g carb My PDM Settings Time that insulin will remain active in the body Name Rate circle from a previous bolus hrs measurement U hr or U hr or U hr or U hr or Correction factor for each time s
204. t then press Save 4 Press Done To rename a temporary basal 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 Save 3 Press Done To delete a temporary basal preset 1 Choose Delete then press Select 2 Press Delete to permanently delete the preset Maximum Basal Rate 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 1 ae a 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 b
205. t does not work or the error persists call Customer Care Retest using a new test strip Do not press any buttons or Soft Keys while applying blood or control solution to the test strip If the error persists call Customer Care 124 Na celle Vela Ga Ae Alarms The OmniPod System provides alarms to make you aware of serious or potentially serious conditions When a condition occurs that requires your attention an Advisory Alarm or a Hazard Alarm will sound Advisory alarms beep intermittently and inform you about a condition that requires your attention During an alarm the PDM will display an on screen message with instructions for taking care of the alarm condition Be sure to respond to all alarms when they occur Details on how to handle an Advisory or a Hazard Alarm are below WARNING NOTE Advisory Alarms Advisory alarms tell you about a condition that requires your attention Each advisory alarm beeps intermittently When you hear an advisory alarm first turn on the PDM to display the Status screen The PDM communicates with the Pod if necessary and the screen displays a message describing the Many alarms such as Auto off will escalate and result in deactivation of the active Pod if ignored Be sure to respond to all alarms when they occur Hazard alarms are continuous tones If the alarm is not acknowledged immediately the Pod will peri odically generate an intermittent alarm tone and then
206. t page 132 Communication Failures 11 A 3 00p 2 11 Communication error 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 d If you 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 time out screen Figure 11 3 Press OK to check the Pod status A 3 00p_ 2 11 Communication timeout Press Ok to check pod status to deactivate pod Discard Press Ok to check pod status or press Discard OK ral 300p 2 11 Communication timeout b Ifthe status check fails you will see the screen in Figure 11 4 Press OK to try checking Pod status again or press Discard to begin the deactivation process 133 11 Communication Failures 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
207. tdxkardersaweses eae 116 hypoglycemia 106 111 115 167 avoiding cece cece eee es 112 CAUSES x05 daswabbatvesohw ods 114 115 SYMPTOMS errieta e 79 111 treating ccc eee aee 112 113 hypoglycemia unawareness 112 167 I CONS nts vet Aaaa 151 152 insulin gauge cece eee 62 ID SCION 2st E E E E 61 E0 0 EE E E E seeeeees 11 SET apa TEREE E ERS ENERE 74 INESS peinter aer E 120 173 INIECTION araia 59 107 infusion set automated insertion 3 infusion site 50 52 59 107 167 infusion site inspection 107 insulin 17 29 44 47 49 108 142 167 insulin action Seeduration of insulin action insulin delivery LESUING uyarsan an t ean 59 SUSDENO 232s oisadioebereneseienes 57 insulin delivery records 98 100 insulin delivery continuous 1 insulin gauge ICON eee ee 62 insulin on board IOB 29 31 143 146 167 insulin reservoir sssesnseenn 62 insulin rapid acting vs long acting 119 insulin to carb IC ratio xi 14 29 65 67 168 interruption in communication 78 IV Prep wipes 2 cece eee eee 77 K ketoacidosis ceceeeeeees See DKA KETONES cece eee ee eee 96 119 168 L lancing TINGE A T 88 upper arm orhand 89 lancing device e eee 85 90 long acting insulin 119 low battery alert 0 140 low blo
208. tem 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 boluses and the grams of carbohy drate 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 When using the extended bolus function the user should check their blood glucose levels more fre quently to avoid hypoglycemia or hyperglycemia WARNING re 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 Geno The suggested bolus calculator will display a sug WARNING gested bolus dose based on the settings
209. 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 e mail 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 product information for your OmniPod System make model serial number You can not change this information 104 The User Info Support icon is also displayed on TPLA the suggested bolus screen For information about the support information displayed on these screens see Chapter 4 Understanding and Deliver ing Bolus Doses Add or change user information entered for the ID screen during your PDM setup For information on editing this line see Chapter 6 Using the Personal Diabetes Manager Customize the Personal Diabetes Manager ie The first line of My Info displays the information that was 1 On the Home screen use the Up Down Controller buttons to choose My records then press Select 2 Choose My info then press Select 3 Choose an existing line or My info Figure 8 15 then press Edit 4 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 5 Press the middle soft key to move the underscore to the next character Understanding Your Records 8 A 100p 3 11
210. test your blood glucose while your PDM is connected via USB cable to a computer Doing so could result in electrical shock This Device is intended for self testing by the user Please read all the instructions provided in this User Guide and practice the testing procedures before using the system and FreeStyle accessories Follow the guidance of a healthcare professional for proper blood glucose monitoring 79 7 Checking Your Blood Glucose n ThE FrEE IIE D1000 GICaSE TESLUI f Do not use strips beyond the expiration date printed i Complete information on the FreeStyle test strips on the package as this may cause inaccurate results such as interferences and performance can be found in the test strip package insert Please read all ff For detailed storage and usage information refer to the instructions provided on the test strip package insert package insert in the box containing the test strip vial before using the OmniPod System and FreeStyle accessories LA The cap or vial contains drying agents that may be harmful if inhaled or swallowed and may cause skin Important test strip information or eye irritation e Store the blood glucose test strip package in a cool dry place between 40 and 86 F 4 4 and 30 C e Use test strips only when the PDM is within its operating tem perature range between 40 and 104 F 4 4 and 40 C The FreeStyle control solution Figure 7 1 isa Keep test st
211. thcare provider will help you determine the correct amount wore The Pod requires a minimum of 85 units of insulin to begin operation ig The Pod can deliver up to 200 units of insulin 41 5 Using the Pod 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 7 Turnthe vial and syringe upside down Withdraw insulin from the vial into the syringe expelling any and all air or air bub bles Fill at least to the MIN minimum fill line Figure 5 9 Refer to the Care Giver Guide as an additional reference wore Any air bubbles present in the fill syringe could be transferred into the reservoir during the fill process The pod does not purge air that is introduced into the reservoir by way of the fill syringe WARNING Remove the needle from the vial and insert it straight down into the insulin fill port on the underside of the Pod Figure 5 10 Failure to expel air bubbles from the fill syringe may result in interrupted insulin delivery Make sure there is no air in the syringe before attempting to fill a Pod with insulin gt gt Be sure to only insert the fill syringe into the fill port Attempting to inject insulin into any other location on the Pod may result in damage to the Pod or loss of insulin To ensure proper fill do not insert the fill
212. to the test strip port until it stops The test strip port is at the bottom of the PDM Lancing device depicted in Figures 7 14 and 7 15 is representative only Please follow the instructions included with your specific lancing device 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 ie From some PDM screens you cannot access the Free To help you see the test strip port in reduced lighting press the middle soft key labeled Light To turn the light off press Light again Insert only the top end of the strip into the test strip port Figure 7 16 and Figure 7 17 Top Bottom 87 7 Checking Your Blood Glucose powers off To restart the PDM take out the unused strip and reinsert it or simply press and hold the Power button to turn on the PDM Refer to page 57 to check Pod status re If you do not start the test within 2 minutes the PDM and to Confirm ID Set the blood glucose test strip code After you insert the strip the PDM displays a code number Figure 7 18 This number must match the code on the side of the vial 3 00p_ 2 11 Enter code 16 Light 6 300p 2 11 Apply a blood sample to the strip Calibration code 16 Li
213. tons to choose a new start time end time target BG value and correct above value correction threshold 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 target BG value and correct above value correction threshold Press Next after each entry c 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 anew minimum BG then press Enter Insulin to carb IC ratio Number of grams of carbohy drate covered by one unit of insulin You can edit existing time segments and add segments up to a total of 8 a To edit an existing IC ratio time segment choose the seg ment then press Edit Use the Up Down Controller butons to choose a new start time end time and IC ratio Press Next after each entry b Review the segment to ensure it is correct then press Confirm c Toaddasegment 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 d When you have completed all time segments press Done then Save Correction factor You can edit existing time segments and add segments up to a total of 8 a Toeditan existing correction factor time segment choose the segment then press
214. u can use the PDM A The Status Screen It is important that you always identify the PDM as yours before you use it When a Pod is active and the PDM is turned on the PDM estab 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 A 3400p 2 11 mr 50 U 3 00p 2 11 PDM ID Last BG 110 mg dL 12 47p today Last bolus 1 20u z 12 47p today Jane Smith OB 0550 basal 1 0 70 U hr Press Confirm if correct Pod exp 10 44a 2 14 Confirm Home The Status screen Figure 6 2 displays e Current date and time e Battery life remaining Insulin remaining 61 6 Using the Personal Diabetes Manager e Time date and result of last blood glucose checked or entered manually e Time date and total amount of last bolus delivered e Amount of insulin on board IOB if suggested bolus calcula tor is in use 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 e INSULIN SUSPENDED if insulin delivery has been suspended e Time and date when the Pod will expire wore Ifa Pod has not yet been activated as in d
215. uations cece ccc eee e ence eee ees 120 SICK Cay Stak cence eens si aecauctae wea hime EAEE E 120 Exercising playing sports or working hard 120 X rays MRIs and CT SCANS cece eee e cect ene eeeecees 121 Surgery or hospitalization cece cece cece cence eees 121 10 Alerts and Alarms ccccccccccccccccccccccces 122 Salety CHECKS 5 035 004 sansa vendos ceeuudeasecartaranee aus eA 122 Blood Glucose Meter Alerts cece cceneeeeeceeeneee 122 AaS sse ra n awe acai T a eae pomeamencsmne an 125 FAOVISORY Alar MS escam rasave aa a Camas ease one 125 Hazard Alann Se eadar eR EE EE A ETTA 125 Manual Shut off of a Hazard Alarm 0cceceeeeeeees 131 11 Communication Failures ecccccccecccccccccees 132 The Communication Process 00 cece cece eee eee eee 132 vi Contents Failure During Pod Activation or Operation 4 132 Failure During Pod Deactivation c cece cece eens 134 Failure During Request for Status cece eee e eee ees 135 Failure During Bolus Cancellation ce cece ee eeee 136 APPENAIN 6 ischincsaue 6 eretto iat Ge cobs eae Secac ees 138 Pod Care and Maintenance c ccc cece cee eeneeeeneees 138 SOL aCe stanton a eat ce ma a edn toes A 138 CIEAMING 56s hssce einen cama eee a ane esas 138 Personal Diabetes Manager Care and Maintenance 138 SONA Ss a6es spots aG stad
216. uidelines ce cece ees 146 supplies packing for travel 109 SUIGCIY recse aRU 121 suspend insulin delivery 57 symbols in history records 064 98 ON SCreeN scexss tecwesouswas 151 152 System labels 00000e 151 symptoms DKA PAA E AE T EE A 119 176 hyperglycemia 606 115 hypoglycemia 79 111 System options and settings 147 System setup Menu 008 63 T tag a BG reading result 84 tags e EE TT 73 92 target BG crscuiisirtir inni 65 169 target blood glucose value 13 temperatures EXIlEMG casscseutersosseisessenand 78 Operating 4 78 148 150 Storage ich idernastiwuaiwanes 148 150 temporary basal 13 68 temporary basal presets 23 28 169 CANCE E EA 27 changesare roei aera 27 d lete yiera i anae 28 GNADIC nresnani e Se 26 eNA E aos wnsdosernde aiae aaan 28 temporary basal rate 23 28 169 temporary basal rate one time 24 test Strips 3 79 80 82 87 COO A EEEE 88 expiration cece eee e eee e ees 80 text entering and changing 18 23 25 28 38 39 40 LING coser mies 11 63 time segment See basal segment time ZONGS veces ence weed eeosciaes 109 travel CONCEINS cece eee eee 109 U Up Down Controller buttons 5 User Guide symbols 064 viii User Info Suppor
217. unications from Us by Alternative Means or at an Alternative Location We will accom modate reasonable requests to receive confidential communications 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 con tact 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 disclo sures 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 informa tion 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
218. uring Pod fe changes the screen displays No active Pod Would you like to activate a Pod now See Chapter 5 Using the Pod for details on activating a Pod 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 Regularly checking the insulin gauge enables you to plan Pod changes easily For example if you know you will need approximately 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 screen press Home 2 Use the Up Down Controller buttons to choose Settings then press Select 3 Choose System setup then press Select 4 Choose an option from the System setup list then press Select Figure 6 3 on the next page Check with your health care provider before making any changes 62 U
219. use the Up Down Controller buttons to choose More actions then press Select 2 Choose Food library then press Select 42 The screen displays a list of main food categories Figure 4 23a and Figure 4 23b Understanding and Delivering Bolus Doses 4 3 To choose directly from the food categories choose a main category then press Select Choose a subcategory then press Select Choose a food item from the subcategory then press View Food library Bread muffins bagels Cereals grain pasta Crackers snacks Beans peas lentils Fruit fruit juices Vegetables Milk milk products Sweets desserts other Done Index Select Y 3 00p_ 2 11 Milk milk products Sweets desserts other Meat meat substitutes Fats Combination foods Fast foods Free foods Done Index Select YI 3 00p 2 11 Food library Vegetables 4 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 5 Press OK to return to the list of main food categories 43 Using the Pod The Pod Change Process Replace the Pod at least once every 48 72 hours or up to 200 units of insulin 2 3 days Refer to the insulin labeling and follow your
220. ve time and date Time 3 00 PM Month February 11 Day 11 Year 2012 Format 2 11 12 Note Setting the correct time is essential to ensure correct basal insulin delivery and BG records Back Confirm Enter basal settings 1 2 Choose a maximum basal rate then press Next The default maximum basal rate is 3 U hr Enter initial basal rate that starts at midnight then press Next Figure 2 5 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 K 3 00p 2 11 5 Segment 12 00a 12 30a Save basal segment 3 00p 2 11 Start 12 00 AM End 12 30 AM Enter basal rate Duration 0 5 hr 0 05 Uhr Rate 0 05 U hr Back Next Back Confirm Press Confirm to accept the basal program you have set Figure 2 6 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 Press Save to accept the basal program you have set To see the basal program as a list press List To return to the graphic view press Graph 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 12 G
221. y c 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 Insulin to carb IC ratio You can edit existing time seg ments and add segments up to a total of 8 a To edit an existing C ratio time segment choose the seg ment then press Edit Figure 6 7 on next page Use the Up Down Controller buttons to choose a new start time end time and IC ratio 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 IC ratio Press Next after each entry c When you have completed all time segments press Done then Save 65 6 Using the Personal Diabetes Manager 5 Reverse correction Choose On or Off then press Next sT 3000 2 11 6 Insulin action duration Use the Up Down Controller Insulin to carb IC ratio buttons to choose a duration of insulin action then press Segment g carb U Done Iaddnew i tttit s 7 Press OK 12 00a 12 00a_ 15 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 8a or choose one setting from the menu then press Select Fi
222. you will return to the beginning of the Setup Wizard p 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 You may want to adjust the PDM screen time out TIPE gt 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 TIP down all your settings from the Setup Wizard If you ever need to reset or replace your PDM having these settings handy will make setup very easy 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 wore Approximately 50 of a person s total daily insulin dose typically comes from basal insulin delivery the remain ing 50 typically comes from bolus doses see Chapter 4 Understanding and Delivering Bolus
223. z an adjustment above your max bolus limit Figure 4 1 PENON AAU and Figure 4 2 Consult your healthcare provider 500u 1 00 uU before changing this setting Deliver an Extended Bolus The extended bolus feature lets the OmniPod System deliver Back Extend Enter Back Enter some or no insulin now and the remainder over a period of time you choose ie To learn how to set extended boluses in percentages or units see Chapter 6 Using the Per Diabet Deliver an extended bolus instead of a normal bolus wae p ng sonal Diabetes Manager 1 After you get your suggested bolus press Extend instead of Enter Figure 4 9 3 Enter the time up to 8 hours in 30 minute increments over core Ifyou have set the Extended bolus option to Off which to deliver the remainder of the bolus then press Enter ea the PDM will not display the Extend Soft Key For Figure 4 11 on the next page In Figure 4 12 on the next information on turning this feature On and Off see page you can see a detailed view of the extended bolus Chapter 6 Using the Personal Diabetes Manager 2 Enter the units of insulin or percentage of the bolus that you want to take immediately Figure 4 10 then press Enter 35 4 Understanding and Delivering Bolus Doses A 3 00p 2 11 A 3 00p 2 11 Extended bolus 3 00 u Start bolus Extend for how long Now 2 00 U aam ftom 3008 Total 5 000

Ust400 - New OmniPod Training & Resources

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Ust400 - New OmniPod Training &amp; Resources

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Ust400 - New OmniPod Training & Resources