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User Guide.

1. 7 Put cartridge tubing assembly aside gt Check for leaks cracks or damage each time you change your cartridge and infusion set To avoid leakage be sure to tighten the Luer connection securely You can check for moisture periodically by wrapping a tissue around the Luer connection between the cartridge and infusion set gt When handling the cartridge take care not to move the plunger from side to side in the cartridge body Maintaining straight alignment of the plunger keeps the o rings properly seated which minimizes the possibility of introducing air into the cartridge and will prevent insulin spillage Changing the Cartridge HA Disconnect infusion set from your body NO Unscrew the cartridge cap leaving tubing connected to the cartridge Lo With the tubing connected to the cartridge pull cartridge straight out of the pump Disconnect tubing from cartridge and discard Proceed with filling the new cartridge as outlined in this chapter Page 31 Priming the Pump and Infusion Set These steps must be followed in order Note As each step is completed the checkbox on the ezPrime menu will be shaded gt Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body Doing so while the infusion set is connected to your body can result in unintended delivery of insulin which can result in serious injury or death 1 Make sure you are disconnected from the pump MA
2. 8 To change the battery type highlight the battery field and press OK to activate Edit mode indicated by flashing cursor 9 Use the Up Down arrows to change battery type and press OK to confirm and exit Edit Mode Note The correct battery type must be selected in order for your battery life indicator to be accurate Lith Lithium Alk Alkaline Your active basal Note Until you have programmed a basal rate the Alert screen shown En i i is emp here will appear when the pump is awakened Simply scroll to Confirm 0 000 U Hr and press OK to move past this Alert screen 10 Scroll to Confirm and press OK The Home screen is displayed Confirm Basal Menu Setup Basics You can use your computer with ezManager to upload Time Date and Sound settings For instructions on uploading basal program information refer to your ezManager User Guide Setting Changing the Time and Date When you change your battery the Verify screen allows you to edit the time and date You can also access the Time Date screen by selecting Setup from the Main Menu 1 From the Home screen press OK to select Menu Scroll to Setup on the Main Menu Press OK 2 Scroll to Time Date on the Setup Menu Press OK SETUP 2 27 pm a Hour Minute Basal Rate 0 025U Hr Insulin 105U Menu 3 Press the OK button to activate Edit Mode indicated by flashing cursor 4 Use the Up Down arrows to change to your desired setting
3. 0 This screen allows you to e Set different BG targets and ranges for 12 different time slots Note If you set only one ratio it will be used for the entire 24 hour period From the Setup Adv 7 screen scroll up to BG Target Press OK 1 The first segment always starts at midnight The last time slot available is 11 30pm Use the Up Down arrows to scroll to the BG target field 2 Press OK to change to flashing cursor for Edit mode SETUP ADV BG Target BG Target BG Target 1 of 12 1 of 12 2 of 12 Use the Up Down arrows to change to desired setting Press OK when setting is made Scroll to the range field Press OK to change to flashing cursor for Edit mode Use the Up Down arrows to change the range as desired Press OK N HO Wo KR W To move to the next BG Target screen scroll to the forward arrows and press OK Page 60 8 Scroll up to the time field and press OK to change to flashing cursor for Edit mode 9 Use the Up Down arrows to change the segment start time Press OK 10 Scroll to the BG Target field Press OK to change to flashing cursor for Edit mode 11 Use the Up Down arrows to change to desired setting 12 Press OK when setting is made 13 Scroll to the range field Press OK to change to flashing cursor for Edit mode 14 Use the Up Down arrows to change the range as desired Press OK Repeat to set remaining segments per your healthcare team s recommendations To review your settings highlight
4. Check ketones Press OK to confirm Monitor BG Beeps Vib User selected one time and each time manually p awakened until confirmed No progression Suit mn Alert Clear Program Basal Segments Clear command selected from Basal Options screen Clear Program Effect Requires user confirmation to continue deletes all Displayed until confirmed or until pump goes basal segments to n p P3 in this program Select Clear Program or Basal Options Clear Program Beeps Vib User selected one time Basal Options Page 82 Alerts Warnings and Alarms Alert Basal Program Display Change J Paice Changing display of basals from 4 to 1 but program 1 is not currently active 1 Weekday must be the Effect Requires user confirmation to continue active program Displayed until confirmed or until pump goes to sleep to change the basal display Action Press OK to confirm setting Beeps Vib User selected one time Confirm Warning Basal Delivery Suspended J Basal Edit was not saved Basal edit Effect eae delivery stopped aa Displayed when manually awakened until confirmed Basal Neen Press OK to select Edit Basal Review basal edits and delivery select Save Review suspended Beeps Vib User selected every 3 minutes until confirmed If not an confirmed progresses to sweep vibe within one hour Warning Suspend J Pump suspended manually Effect All deliveries stop No Delivery Meccane Displayed each
5. Here s everything Yau Ii need toen Technical and Clinical Help If there is anything you don t understand in the User Guide if you have a question or need assistance with your pump our Pump Support Department is available to you 24 7 In the United States Canada and Puerto Rico call 1 877 767 7373 for assistance every minute of every day For non urgent technical questions please email customersupport anmus jnj com Outside the United States Canada and Puerto Rico call 1 610 644 8990 or contact your local Animas distributor Page 2 Table of Contents Welcome ant GONE IO AS ctr se isracaemcsedoaeseresenessaeeusseencsaaeouseeseseosoacnieaeceastseuenseucaeonee 7 Technicatand Gli Cat HEI rerrserersiriri irera NaN SEEE EEE EEE EN EESIN 8 Sr ROCOCO oera a E E E E AE 8 aaan gea Lo 8 Chapteri Important intomen nsvnntentiernianrntermerntnetindtnbrmnetie 9 En 9 FIMGVGe K sossen never ankeren erneer ennen stee seseiasennecsuacs oen 9 Macaon tor USS uaa kan dereberdereen etsen stevende 10 COMET ALG oere on 10 Warnings and Precautions naren sotcucacuetarscosessserecccansedusonteeseetsececaasaemesaybsedeveacncsdicece 10 Radiology X rays and Medical Procedure Quick Reference Chart 12 Ster MOTION asen ou sinaiececuietc cutie stvennnavsensasiveteucacemsets EEEE 14 Chapter2 Package CONTENUS meenemen rkenen rent OREN RDE 17 Chapters Explanakon OF SVIDOIS ercour pee ceacennnccemeceutwsestessmenocsatestaenestecetanseeteusunuonesees
6. 1 877 937 7867 and press 2 for Reorders In Canada call Animas Canada Customer Care at 1 866 406 4844 and select the desired language In the United Kingdom call free phone 0800 055 6606 In Ireland call 1 800 812 715 All other countries call your local Animas distributor Please note that the Animas insulin pump limited warranty does not cover damage resulting from normal wear and tear accidents negligence or misuse and abuse including scratched display lenses We urge you to protect your pump screen from damage and use a lens protection film at all times e The screen displays shown in this User Guide are examples only and should not be considered suggestions for individual programming e Blood Glucose is abbreviated throughout this User Guide with BG Page 8 Chapter 1 Important Information This User Guide contains information about how to use program and maintain your new pump It is important to read it carefully Even if you are an experienced pumper keep your User Guide handy for reference Warnings cautions and safety tips are found throughout this Guide indicated by a gt symbol Warnings gt Do not attempt to connect to the pump before you have been trained on the Animas 2020 or unless your Certified Animas 2020 Pump Trainer is present gt Incorrect use of your pump failure to follow the instructions in this User Guide or improper inadequate self care and troubleshooting techniques can lead to death
7. This means if you do not confirm the Warning or Alarm it will progress to the sweep alarm with vibrate within one hour At the high volume stage if you do not confirm the Warning or Alarm the sweep alarm will begin and will not stop until appropriate action is taken Note Your pump uses battery power to notify you of reminders alerts warnings and alarms If you do not confirm the notification your pump will continue to use battery power as the notifications repeat and progress This will result in reduced battery life and the Replace Battery Alarm screen appearing sooner than expected Additionally certain warnings e g Empty Cartridge Alarm take precedence over less critical ones e g Low Battery Warning This means if you do not confirm the more critical warning battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm or the battery life will end before a Replace Battery Alarm is displayed Alerts are automatically displayed to remind you of a function that you ve set or a condition that exists Warnings are triggered for a variety of reasons They require you to confirm the warning by pressing OK and or taking action to address the warning Alarms are triggered by several conditions All require you to address the alarm by taking appropriate action in order to clear the alarm condition J Indicates that this Alert Warning or Alarm can play a tune as the initial no
8. all 4 basal program options will be displayed as shown on screen example below right gt The lowest basal delivery amount possible is 0 025 U hr The highest basal delivery amount possible is 25 U hr or the Max Basal amount you set in Setup Advanced See Chapter 11 Advanced Features Page 41 1 From Basal Menu scroll to Temp Press OK BASAL MENU Total 0 00U BASAL MENU Total 0 00U A 1 WEEKDAY 3 weekend 4 exercise 2 The Change field will flash to indicate Edit mode Use the Up Down arrows to enter the percentage change desired Press OK button to exit Edit mode 3 Duration field is highlighted Press OK to activate Edit mode A 1 WEEKDAY A1 WEEKDAY A 1 WEEKDAY TEMP BASAL TEMP BASAL TEMP BASAL Temp Active Minimum Basal rate limited to 0 025 U Hr 4 Use the Up Down arrows to enter the duration desired Press OK to exit Edit mode 5 Go is highlighted Press OK to activate Temp Basal gt The lowest basal delivery amount possible is 0 025 U hr When you set a negative temporary basal rate the pump will beep and display an Alert screen to remind you of the minimum delivery limit This screen will display once for 5 seconds and give one audible alert if you turned on Alert sounds in Setup Page 42 6 The Home screen is displayed and shows your Temp Basal is active the percentage change the duration and how much time is left When the duration of time is complete your pump will automati
9. e A letter from your physician that explains the necessity of carrying insulin supplies and wearing an insulin pump e A prescription for insulin both rapid acting for your pump and the type recommended by your healthcare team in case you need to take insulin by injection Remember the pump is designed and calibrated to use U100 concentration insulin only Use of any insulin with lesser or greater concentration can result in serious injury or death e Emergency supplies listed in Chapter 1 e Accessible snacks e Bottled water to prevent dehydration while flying Remember to check your blood glucose frequently to distinguish between high blood sugar dehydration and normal flight dehydration e The name of a referral physician at your final destination in case of an emergency Page 95 Traveling continued e Pack your insulin carefully so that it is not exposed to extreme temperatures or temperature changes e Pack your pump supplies in carry on luggage when traveling by air or train Do not pack your supplies in checked luggage Contact the Federal Aviation Administration or your country equivalent or your local airport security office before traveling by air to obtain prescription medical supply carry on regulations e Adjust your pumps clock when crossing time zones e Insulin pumps will rarely set off airport metal detectors so there is no need to remove your pump when passing through airport security However as airport security techn
10. pads or sharp instruments to clean the pump Never put your pump in the dishwasher or use very hot water to clean it Use only a very mild detergent for example a drop of liquid soap in a glass of water and a lint free cloth gt Never put your pump in a microwave oven or baking oven to dry it Use a soft towel Page 79 General Wear and Tear If you drop the pump or it has been hit against something hard inspect it to be sure it is still working properly Check that the display screen is working and clear that the cartridge cap battery cap and infusion set are properly in place Check for leaks around the cartridge by wrapping a piece of tissue around the connection area Cracks chips or damage to the pump may impact the battery contact and or the waterproof feature of your pump Call our 24 7 Pump Support Department at 877 767 7373 if you identify or suspect your pump is damaged They will help determine if your pump should be replaced Outside the US amp Canada contact your local Animas distributor Disposal International and US regulations require controlled disposal of devices such as insulin pumps Residents of US Canada and Puerto Rico dispose of in accordance with federal state and local regulations All other customers contact your local Animas distributor for disposal Page 80 Chapter 14 Safety System and Alarms Alerts Warnings and Alarms Your Animas pump has a progressive Warnings and Alarms safety system
11. press OK Page 37 MAIN MENU BASAL MENU BASAL MENU BASAL MENU Total 0 00U Total Temp A 1 WEEKDAY A 1 WEEKDAY A 1 WEEKDAY 2 other 3 weekend 4 exercise een Note You do not have to Suspend the pump to edit an active program When you select Edit from the Basal Menu your Animas 2020 automatically suspends delivery When you exit the Edit mode the active program delivery automatically resumes 4 The Basal Options screen is displayed Edit is highlighted Press the OK button From the Edit Basal screen you can edit the basal segments of the selected program BASAL OPTIONS EDIT BASAL 0 00U U Hr SavelReview 5 Scroll to the desired U hr field Press OK to activate Edit mode indicated by flashing cursor 6 Use Up Down arrows to set desired basal rate Press OK to confirm and exit Edit mode for this field EDIT BASAL EDIT BASAL EDIT BASAL 0 60U 13 60U U Hr 7 Scroll down to select the next Start time field Press the OK button to activate Edit mode indicated by flashing cursor Page 38 Note The next available empty basal segment will appear automatically as you program the previous segment If the next empty basal segment does not appear you have programmed all 12 possible segments 8 Change next Start time field as desired press the OK button to exit Edit mode Segments can start on the hour or half hour Note The 24 hour Total changes automatically as you change U hr settings 9 Con
12. setting changing 28 status feature 51 supply reordering 8 suspend history 49 Page 117 suspending delivery 45 suspend temp basal combo bolus canceled alert 82 suspend warning 83 swimming 95 tamper resistant feature 23 technical and clinical help 2 temp basal 42 43 45 48 52 temp basal minimum rate alert 81 temporary basal feature see temp bazal time out 23 total daily dose tdd history 48 traveling 95 troubleshooting guidelines 87 upload 14 wake up screen 23 warranty 25 111 waterproof 13 16 80 x rays 12 Page 118 A nimas RPORATI O a Gohusenafohwren company 200 Lawrence Drive West Chester PA 19380 USA Animas has received both ISO 13485 2003 International Organization for Standardization certification and The Joint Commission accreditation By meeting these most rigorous standards Animas is committed to superior quality and safety for its customers Customer Service is available 24 hours a day 7 days a week U S Canada amp Puerto Rico 1 877 YES PUMP 937 7867 All other countries contact your local Animas Distributor or call 610 644 8990 CAUTION Federal U S law restricts this device to sale by or on the order of a physician Rx Only US 2009 Animas Corporation All rights reserved Covered by U S patent 6 656 148 Other patents pending Glucagon Emergency Kit is a trademark of Eli Lilly and 410 055 00 Company Energizer is a trademark of the Evere
13. 1 From the Setup Menu select Advanced 2 Scroll to Setup Advanced screen 9 3 Enter or review the guidelines as recommended by your healthcare team Page 78 Chapter 13 Care and Maintenance The Vents Your Animas 2020 features a redundant Vent Safety System Vents serve two purposes First they allow air to pass through the pump so that pressure is equalized under a variety of environmental circumstances such as changes in altitude Second the vents are backed by a special membrane which keeps water from entering the pump Battery Cap with O ring and Vent Your battery cap contains a yellow o ring and vent There is a tiny hole backed by a membrane which allows air to pass through but prevents water from entering The o ring helps to keep your pump waterproof It is recommended that you change the battery cap vent every 6 months If you work in a dusty environment such as a construction site mill cement factory etc or if you are a frequent swimmer you should change your battery cap every 3 months You can call Animas to order an extra O ring Vent Hole gt Under no circumstances should you introduce any kind of sharp object into the vent openings to clean them Doing so could compromise the pump s waterproof capabilities If at any time you suspect the vent opening is clogged replace the battery cap Cleaning CAUTION Do not use household or industrial cleaners chemicals solvents bleach scouring
14. 19 Chapter 4 Introduction to Your Animas 2020 Pump wassrersserernerseversdeoisenverseknnndd ende 21 Get to Know Your Animas 2020 ssessessesseesssoseseessesersosesesosesessosesesosessessseceeoseseeess 21 Man Poara Ee BU O E E E E E EN 21 Poorana BASICS esr eE EE E A EEE EEEE AS 21 Display TE eaan E EE E EI NAE EE EE EA E E 21 GOMLEASE DOLON eeror cata r EEEE EEE 22 Aadio BOMS ZBO renn E E A A OEE 22 Balten Gap Vent ranen E EE EEE E A EE S 22 Pray V r EE E EEEE E E I E E EAE E 22 Cartridge Compartment CAP smerende E ras 23 IR Window TOL Dow Oa ccccenconenssaaeesouncececsesenseeousenawsesueuacsescoasunueencacsessuessescneeuas 23 OUN ae A EE EEEE E EEE EEA EEE EAS 23 Tamper Resistant Locked Feature ncasssantccacsehewsnnediuneseetanae chessnaneweeseseeadeiiuvanenenensens 23 Ba eD Ay C1 CONS E E EEEE ETE 23 Ven a E E E E E I E Ens 23 BOTS OCLC eere E E A E E EE E E E SS 23 Main Meni C OT e aa E T E ERE EE TEE E E EE 24 DS E S E EEE EA E E E EEAS 24 Chapters Getumo Your Pump Ready ccc ncssmsccosasacosscocunavasenccsncenacsencssmsesesessasaseonnsweesees 25 Boe Sei O EE A E E E EEA EE SETE 25 GRON GTN BE aer eE EE E E E EN A E E 26 DOU eE L e E EE V A EE A ERE E A EE E 27 Setting Changing the Time and Date ccccecececececesescscscecececececececececececeseseees 27 Dayugnt saving TIME ccrcssscircensiecisds Keni unenee EN E Ea EE EERE 28 Sra Ee aT A ra EE A EE E E EEE Rnd 28 eCa ea E E EEEE E 30 PINE CG Cage eera E E E E E
15. DMEPOS quality standards and be separately accredited in order to bill Medicare All suppliers must disclose upon enrollment all products and services including the addition of new product lines for which they are seeking accreditation Must meet the surety bond requirements specified in 42 C F R 424 57 c Note Supplier standards 22 25 are effective September 30 2009 Page 116 index active basal program empty alert 81 advanced bolus 36 56 65 advanced features 55 aicd 11 air bubbles 15 aircraft 13 alarm history 48 amusement parks 13 audio bolus 15 22 28 55 63 110 audio bolus delivery step size 55 auto dim 22 auto off alarm 86 auto off feature 57 basal delivery suspended warning 83 basal history 50 basal program features 37 battery 16 27 battery cap 79 battery cap vent 22 battery insertion 25 bg check reminder 76 bg correction calculator see ezbg bolus delivery speed 56 77 bolus history 47 call service alarm 86 carb calculator see ezcarb 15 carbon zinc batteries 16 25 cardiac catheter 11 cartridge 14 15 cell phones 16 changing the battery 26 changing the cartridge 31 clear program basal segments alert 82 colonoscopy 11 combo bolus 15 45 52 56 65 76 contrast 22 57 contrast button 19 correction bolus see ezbg damage 25 daylight saving time 28 display timeout setting 57 disposal 80 dka 88 91 download 14 47 edit mode 21 ekg 11 electromagnetic fields 10 elec
16. EE EE 76 Delivery Speed Bolus sessssessssssessesseesecsccseesserscesocseceserscesosseesseseessorsoreceeseeesesse 77 tre Basal HOC Val smsen teheran sane 77 MUUN OBO NOE EEE E E EE E E E 77 MD ED E E E E E E 78 Chapter 13 Care and Maintenance essessssessesseesscssecesccsscecsccesecesocsscesecsseeesecssceeeesseeee 79 eN ea A E E E E E E EEA 79 Battery Cap with O ring and Vent semen deaosekorerneesnendrabebtene delende neten ore ueaeuccamens 79 EE ai a oo E ec E EAE A E N E de E 79 General Wear and FOAM doce ccancccccencsseiavc cen tacsusessadaeebeeacouse E EErEE e Eerie eE 80 DI POSA oera EEEE ET EEA A I EEEE E EE E OT EEE 80 Chapter 14 Safety System and Alarms sessessesseesessoeseesocsecsseesersorsoesseeseesorseesoeeeeseees 81 Chapter 15 Troubleshooting Guidelines essesseeseeseeseeseeseesseesesseesoesseeseesorseesoeeeeseees 87 FAO Gy COT T AEE EE A T A EEE ETE E T E E 87 aE a OI e E E SE E E E E AT SE EAE AE E A T E E 88 Problems with Intusion Sets and SILOS co cserers c sos decnnecsenenensce cea sconces csevenecerenbacenecoueescuae 91 DKEA Dipen C Ke Oac1d651S lt 2 cpcnsceasen EEEE E E E N EEE ENN ESES 91 Chapter 16 Sick Day Guidelines essessssseesseseesseesersceesoesscesersorsorsoescsesseesessoesecseeeseeeees 93 Meda ae E E E EE E E E 93 Bood ana Urne TESE errereen ES E EEE A E E EEE EEE EEEE TEE 93 P A UCU e E EE E E E EEE EEE EEEE E E 93 Chapter 17 Lifestyle ISSUES annesnervernnhnonsepesmtkerentht
17. Press OK to confirm Replace with filled cartridge User selected every 3 minutes until confirmed If not Confirm confirmed progresses to sweep vibe within one hour Beeps Vib Warning Exceeds Max Bolus Audio bolus delivery exceeds user set maximum Exceeds max bolus Effect ou delivery stops xX XX Displayed when manually awakened until confirmed heen Press OK to confirm Reprogram max bolus amount in No bolus Setup Advanced CALMAN Beeps Vib User selected every 3 minutes until confirmed If not Confirm i confirmed progresses to sweep vibe within one hour Warning Exceeds Max TDD J Bolus delivery exceeds user set maximum Bels Effect All deliveries may stop until action is taken max TDD f XXX U Displayed when manually awakened until confirmed N Press OK to confirm Reprogram max TDD amount in No delivery Action Setup Advanced Beeps Vib User selected every 3 minutes until confirmed If not P confirmed progresses to sweep vibe within one hour Page 84 Alerts Warnings and Alarms Warning Exceeds Max Basal J Paige Basal delivery rate or Temp Basal delivery exceeds user set maximum Exceeds Effect Basal delivery stops max basal XX XXX U Hr Displayed when awakened by basal delivery attempt Message every 3 min or manually until confirmed No basal Press OK to confirm Reprogram Max Basal amount in delivery cron Setup Advanced or reprogram Temp Basal gt ae 5 Confirm En Beep
18. The Bolus Total screen is displayed and the Bolus amount field is highlighted and flashing 6 Enter the Bolus amount Go is highlighted Press OK to deliver or scroll to Type field to select Combo Bolus then select Go See this chapter Combo Bolus Entering Carbs Using the Food Database gt Your pump comes pre loaded with a sample food database A reference sheet for your pre loaded food database is included with your other pump kit paperwork You should keep this reference sheet with you to ensure you understand the abbreviated food names and serving sizes Failure to use the reference sheet to confirm your food selection could result in too much or too little insulin being calculated for your food bolus If you do not want a food database or if you would like to customize your food database refer to your ezManager User Guide included with the software 1 From the Bolus Menu select ezCarb Press OK 2 On the ezCarb Home screen press OK to exit Edit mode Food List is highlighted Press OK to select 3 The first Food List page is displayed There are 3 pages of Food List categories To move through the pages scroll to the backward or forward arrows and press OK Repeat to view the third page of the Food List Food List Food List Food List Carbs Actual Main Menu 4 Scroll up to the desired Food List category Press OK to select Cereals 1 List an CheerBar HN fa Cheerios Cheerios AC Cheerios BB Cheerios
19. a message reminding you that this mode not only suspends your active basal delivery but also cancels any Temp Basal or Combo Bolus that may be active MAIN MENU Pump Delivery Suspend Pump Suspended If active Temp Basal amp Combo Bolus have been canceled Warning No Delivery SUSPENDED Basal Rate 0 675U Hr Insulin 105U Menu Pump is suspended Confirm mmm 3 The Home screen is then displayed showing that pump deliveries are suspended Note Periodically the pump will beep or vibrate if that is the setting you selected to remind you of the Suspend status If not confirmed the beeps will progress to high volume in one hour You can confirm the Warning to reset the audible sequence See Chapter 14 Safety System and Alarms Page 45 Resuming Delivery 1 From the Main Menu scroll down to Suspnd Resum 2 Resume is highlighted Press OK 3 The Home screen is displayed to show you the pump is no longer in Suspend mode Your previously active basal program is automatically resumed MAIN MENU Pump Suspended 2 27 pm Suspnd Resum at 1 13PM am Oct 2 2003 Basal Rate Resume 0 675U Hr Pe Insulin 105U Menu Page 46 Chapter 9 History Feature Your Animas 2020 stores important records for your review You can access your pump s history and view it directly on the pump screen or download it onto your computer using ezManager Refer to the User Guide included with the software The
20. fits securely and is not torn or damaged 3 Check the vent hole on the top of the battery cap to be sure it is clear of debris This vent maintains pressurization while preventing water from entering the compartment The battery cap should be replaced every six months or sooner if the o ring or cap is damaged or the vent is clogged See Chapter 13 Care and Maintenance Yellow o ring Battery Cap Vent Hole 4 Insert the Energizer Lithium L91 AA 1 5V battery into the battery compartment with the positive end going in first 5 Replace the cap by turning clockwise until you cannot see the o ring Then slowly tighten the cap until flush f ma y 3 ER 5 A Va Lithium L91 AA battery an p Hf 7 ji a SJ 11 ha Ne AS G Page 26 6 Each time you change the battery your Animas 2020 will run a series of self tests which will last a few seconds The Animas logo will be displayed briefly The pump will give a beep to alert you to verify or change the time date language and battery type 7 Check the displayed time date battery type and language If correct scroll down to highlight Confirm and press the OK button The Home screen will be displayed For more details on changing the time and date see next section Setup Basics Setting Changing Time and Date VERIFY Note The time and date must be programmed to Confirm the Verify screen
21. for single use only DKA Diabetic Ketoacidosis Hyperglycemia can lead to DKA If your BG is above 250 mg dL 13 5 mmol L check blood or urine ketones per your healthcare team Remember the first signs of DKA are often nausea and vomiting Also remember that because you no longer have long acting insulin in your system DKA can develop quickly if you ignore and or fail to troubleshoot potential problems Page 91 Page 92 Chapter 16 Sick Day Guidelines During periods of short term illness it may be more difficult to maintain good control of your diabetes Examples of minor illness are dental surgery colds nausea vomiting sore throat mild infections diarrhea fever However you should call your healthcare team if Illness persists without improvement for 24 48 hours Temperature rises above 100 Fahrenheit or 38 Celsius Vomiting or diarrhea continues longer than 4 hours There are moderate to large amounts of ketones in urine BG levels continue to run less than 60 mg dL 3 5 mmol L or above 250 mg dL 13 5 mmol L above 130 mg dL 7 0 mmol L during pregnancy after taking extra bolus doses as prearranged by your healthcare team e You show signs of ketoacidosis dehydration or other serious problems such as increased drowsiness abdominal or chest pain difficulty breathing fruity odor to the breath dry cracked lips mouth or tongue e Any uncertainty as to what to do to take care of yourself Never omi
22. guidelines SMBG Self monitoring of BG Infrequent BG testing Check BG minimum of 4 times a day more often if BG goals are not met Check BG at 3 am weekly after rates have been set History of unconsciousness or May need to adjust BG target range Consult healthcare team severe hypoglycemia History of hypoglycemic May need to adjust BG target range Consult healthcare team unawareness Insulin sensitive May need to adjust sensitivity factor Consult healthcare team May need to adjust BG target range Consult healthcare team If you experience frequent or severe episodes of hypoglycemia contact your healthcare team It may be necessary to adjust your basal rates or review your target glucose goals along with your daily regimen of food and exercise If you have a low blood glucose level hypoglycemia follow the routine established for you by your healthcare team e It is important to monitor your blood glucose frequently including periodic checks at 3 00 AM e Investigate the cause of hypoglycemia Hyperglycemia Because the insulin pump uses only rapid acting insulin you will not have a reserve of long acting insulin in your body This means that any interruption in the delivery of insulin by your pump can quickly result in a sharp rise of your blood glucose levels Hyperglycemia high blood sugar can occur within two to four hours after insulin delivery stops and DKA diabetic ketoacidosis can develop within fou
23. is available only to the original retail purchaser and excludes damage resulting from abuse accident modifications or other causes that are not defects in materials and workmanship TO THE EXTENT PERMITTED BY APPLICABLE LAW ANIMAS IS NOT LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR SERVICE OF THE PRODUCT THE WARRANTY AND REMEDIES DESCRIBED ABOVE ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES REMEDIES AND CONDITIONS WHETHER ORAL WRITTEN EXPRESS STATUTORY OR IMPLIED TO THE EXTENT PERMITTED BY APPLICABLE LAW ANIMAS DISCLAIMS ALL IMPLIED AND STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IF IMPLIED WARRANTIES CANNOT BE DISCLAIMED THEN SUCH WARRANTIES ARE LIMITED IN DURATION TO THE DURATION OF THIS WARRANTY Any recovery is limited to the original purchase price No other person is authorized to modify this limited warranty Some states do not allow limitations on how long an implied warranty lasts or exclusions of incidental or consequential damages so the above limitations may not apply to you This warranty gives you specific legal rights and you may have other rights which vary from state to state Page 112 Patient Bill of Rights and Responsibilities It is the intent of Animas Corporation to address and respect patients rights in providing care and services It is the policy of Animas Corporation to provide services to all pati
24. or serious injury If you do not understand something or have questions ask your healthcare team or call our 24 7 Pump Support Department at 1 877 767 7373 Outside the US Canada and Puerto Rico contact your local Animas distributor gt Your Animas pump is designed to deliver insulin reliably but because the pump uses only rapid acting insulin you will not have long acting insulin in your body To avoid the risk of Diabetic Ketoacidosis DKA or very high blood glucose BG you must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason gt Your Animas pump is designed and calibrated to deliver U100 insulin Use of any insulin with lesser or greater concentration can result in serious injury or death gt Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body Doing so while the infusion set is connected to your body can result in unintended delivery of insulin which can result in serious injury or death Emergency Kit Keep an emergency kit with you at all times to make sure you always have necessary supplies This kit should include but is not limited to e Quick acting glucose tablets or gel e Blood glucose monitoring supplies including meter strips lancing device lancets meter batteries e Blood or urine ketone testing supplies Rapid acting insulin and syringe with directions from your healthcare team regarding how much insulin to take in th
25. other than those specified are used gt Do not connect infusion set to your body until after you have completed the Prime process 1 Clean the workspace where you will be connecting the infusion set to the cartridge Wash your hands thoroughly with soap and water 2 Open sterile infusion set package carefully If the package is damaged or opened use another set and contact your supplier 3 Unscrew the cartridge compartment cap from the pump using a counter clockwise motion 4 Remove infusion set tubing cap from the Luer connector Not all infusion sets have these caps 5 After removing protective cap thread the Luer connector of the infusion set through the top smaller opening of the cartridge compartment cap being careful not to touch Luer connector with hands or work surface Luer connector of infusion set NCS OX Top of cartridge compartment cap Correctly threaded through cap Page 30 6 Remove cap from the filled cartridge tip To avoid insulin spillage and introduction of air in the cartridge it should never be filled beyond the 2 0 mL mark The plunger is properly positioned for maximum fill when the black o ring nearest the plunger tip is centered on the 2 0 mL mark Attach infusion set Luer connector to cartridge tip using clockwise motion until finger tight and then twist another quarter of a turn gt Be sure to twist the Luer connector an extra quarter of a turn to ensure a secure connection
26. patient should accept shared responsibility for the outcomes of care treatment services or what they are expected to do The patient is involved in resolving ethical issues The patient has a right to confidentiality and privacy with regards to his or her medical information The patient should notify Animas Customer Support with concerns related to product or service issues The patient has a right to have his or her property respected The patient should be considerate and respectful of Animas employees The patient should meet any financial obligation agreed to with Animas The Animas Inside Sales Department will discuss billing of co pays and deductibles including whether the patient has ongoing ability to pay for supplies Animas will also address patients who lose insurance coverage The patient has a right to have his or her communication needs met Animas will work with the patient to ensure that any language requirements including sign language and any additional educational needs are met If the patient believes that they have been denied a benefit of service because of race color national origin religion sex age or disability they may file a Complaint of Discrimination with the Manager of Animas Customer Service Department either verbally or in writing Page 113 If the complaint is filed in writing it should include a name address phone number and a brief description of what occurred which led to the belief t
27. personal settings are correct gt Occasionally check to make sure the pump emits audible tones that are easily detectable For example the audible tones should be heard every time you replace the battery gt If using the upload or download feature keep the communication window free of obstructions and refer to the Instructions for Use included with the IR infra red Accessory Kit Contact your local Animas distributor for information on ezManager Software and IR Accessory Kit To find out if your pump model is compatible with your ezManager software go to the pump download feature on ezManager and check the drop down box for your pump model number If your model number is not an option call Customer Support at 1 877 767 7373 Note Your pump uses battery power to notify you of reminders alerts warnings and alarms If you do not confirm the notification your pump will continue to use battery power as the notifications repeat and progress This will result in reduced battery lfe and the Replace Battery Alarm screen appearing sooner than expected Additionally certain warnings e g Low Cartridge Warning Occlusion Alarm take precedence over less critical ones e g Low Battery Warning This means if you do not confirm the more critical warning battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm or the battery life will end before a Replace Battery Alar
28. the forward arrows and press OK to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press OK to return to the Setup Adv screen To return to the Home screen scroll to Home and press OK Setup Advanced 8 Insulin on Board Setting Even with rapid acting insulin your body takes some time to use your entire bolus This feature allows you to program the rate at which your body uses your bolus When this feature is activated and you give a bolus your pump will tell you how much Insulin on Board IOB is currently remaining and will calculate a decreased bolus dose as an option This helps to prevent stacking insulin and can help reduce your risk of hypoglycemia The duration of insulin action varies from person to person and can vary based on the infusion site you have selected and your activity level among other factors Your healthcare team will give you a recommended duration to program into your Animas 2020 gt This feature is intended for use only with U100 rapid acting insulin analogs such as Novolog Humalog or Apidra If you use an insulin other than Novolog Humalog or Apidra do not use this feature Use of any insulin with lesser or greater concentration can result in serious injury or death This screen allows you to e Turn the OB feature on or off e Select the duration Use the Up Down arrows to scroll to the desired field SETUP ADV 8 In
29. this chapter you should have completed your pump start training and or watched your training video To complete this section you will need the following items e Animas 2020 Insulin Pump Energizer Lithium L91 AA battery 1 5V Coin Infusion set with standard Luer connector Animas 2 0 mL Cartridge 200 unit 2ml Alcohol wipe to clean top of insulin vial Vial of U100 insulin rapid acting or regular at room temperature Skin prep such as IV Prep to clean and prepare site for infusion set insertion gt Under no circumstances should you use an alcohol wipe or skin prep such as IV Prep to clean the pump itself See Chapter 13 Care and Maintenance Battery Insertion Your Animas 2020 pump is designed to achieve optimum performance and battery longevity with an Energizer Lithium L91 AA battery 1 5V gt Itis possible to safely power your Animas 2020 pump with a conventional AA Alkaline battery 1 5V but battery life is significantly reduced Be sure you select the correct Battery Type on the Verify screen when you change the battery to ensure accuracy of battery life indicator If you must use an AA Alkaline battery the following is recommended e Energizer E91 labeled as Energizer MAX gt Rechargeable batteries and Carbon Zinc batteries do not have the necessary characteristics to power the pump and must not be used Use of these batteries voids your pump warranty gt Under no circumstances should you a
30. time or opt not to be reminded by entering 0 For example if you have given a bolus in the evening you may not wish the Reminder to sound while you are sleeping If the Reminder is not acknowledged battery life will be reduced and the Replace Battery Alarm will appear sooner than expected 3 When finished setting reminders scroll to Main Menu to display the Main Menu gt When you enter a time the pump will sound a reminder after any Normal Bolus is programmed including the Normal portion of a Combo Bolus If you program an Extended Bolus only the reminder will not sound Page 76 Delivery Speed Bolus On rare occasions usually with very large boluses users may experience a slight stinging sensation with rapid bolus delivery If this is a concern you can set the bolus delivery speed to slow to accommodate your needs If you use the slow setting your pump will pause approximately 4 seconds in between delivery of each unit of insulin programmed BASAL MENU Total 13 60U Multiple Basal Programs This feature allows 4 different Basal programs to show on your Basal A 1 WEEKDAY Menu screen Users find this feature beneficial if their activity level a Sant is different during the week than on weekends Switching work shifts A exercise at work is another reason to use multiple basal programs Some use Main Menu a different basal program during menstruation ALERT 1 Weekday must be the Note If a program other than 1 W
31. will show the remaining insulin amount gt The maximum number of Audio Bolus button presses is 20 Therefore if you ve set the step size to 0 1 U the maximum audio bolus amount is 2 U If you ve set the step size at 0 5 U the maximum audio bolus amount is 10 U and if your step size is 1 0 U the maximum audio bolus amount is 20 U With a 5 0 U step size the maximum cannot be greater than 35 U which is the maximum amount for any type of bolus Page 64 ezBolus NORMAL BOLUS If you do not have your Audio Bolus feature turned on the button on the end of the pump will function as a short cut to the Normal Bolus screen 0 00U 1 Press the button on the end once The Normal Bolus screen is displayed Program a Normal Bolus as usual Main Menu Advanced Bolus Features ezCarb ezBG Combo Bolus Reminders Reminders All Advanced Bolus features are activated in the Setup Advanced Menu See Chapter 11 Advanced Features When the Advanced Bolus features and Reminders are activated the full Bolus Menu is displayed ezCarb This feature allows you to enter the number of carbs eaten either manually or by selecting an item or items from the ezCarb food database The pump will automatically calculate your bolus dose based on the insulin to carb I C ratio insulin sensitivity factor ISF and target BG you have entered for the current time of day Consult your healthcare team for your personal insulin to carb ratios ISF s and ta
32. 0 cm If the pump is placed at a vertically lower position than the infusion site this condition is eliminated Occasionally check the infusion site for proper placement and leaks Improperly placed infusion sites or leaks around the infusion site can result in under infusion Occasionally check the infusion set tubing for any damage leaks or kinks while using the pump Damaged leaking or kinked tubing may restrict or stop insulin delivery and result in under infusion Only use Animas 2 0 mL Cartridges 200 unit 2ml and infusion sets with a standard Luer connector Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used or if cartridges are used more than once Always dispose of used cartridges and infusion sets following the regulations in your community Insulin can be absorbed through the skin Minimize any contact with insulin and wash hands thoroughly after handling any devices that contain insulin Failure to follow these guidelines may pose health hazards Prior to replacing the battery cap make sure the o ring yellow fits securely and is not damaged See Chapter 5 Getting Your Pump Ready Page 13 gt Prior to inserting a cartridge into the pump check the o rings on the cartridge to be sure they are not damaged gt Occasionally check the vents to be sure they are clear of debris See Chapter 13 Care and Maintenance gt Occasionally check that your pump
33. 30 Connecting the Tubing to the Cartridge eseeseessesseesesseeseesecssesscsserseesoeseeeseeseesee 30 chano NE C GE N E EE E EEE E EEA 31 Priming the Pamp a d Iniusion Set deine deecacacscecsnecunes ceansununrasanestmeedcossesa ENEN 32 Selecting the Infusion Site and Inserting the Infusion Set nnen 34 Changing the Cartridge and Infusion Set scscsescsnsicasacssioesaccisiccetnesestarsscetestucesncsanetevess 34 Page 3 Chapter 6 Using the Normal Bolus Feature cccececececscecececececececececesesescscsceeeees 35 Chapter 7 Using Basal Program Fed Wes wasenteaensesern ennen sen 37 DOE e e e E A o at EE EEE OAE EA EE E EE E 37 Adding Changing Segments in an Existing Basal Program cscscscsceceececececscecececees 39 Reviewing Basal PrOOTAMS ccccaseis sveeseencecacsansetesenecassu dena tucieum sausaceeedeceoasaowseerehecendesatuaiees 40 Clearing Basal SLOGANS eeccnestacvedsmsevess ermede RETE 41 TOT DOT Basak FAES anssen onbe canedoaencsesercacoesenetsenyssueceubeanannetnereseueesenconeecsasers 41 Canceling a Temporary Basal Progia M naren tetek nsne vennen 43 Chapter 8 Suspend Resume Feature scscssvscsvinricsvasouderasvsiwesincaveseudsese vacpevencnveseidenee vere 45 S IE E a A E E E E A N 45 RSW IMEING DETO eco conrccs ennen EE EE EEN NEE E E EEE TR 46 Chapter9 TSO FeatUlesssseiriserissusreresie ri tins EsEgeEMeN ENEO NENET ERBETEN ENERO N ENESE es 47 POS HISTOL arenen cate vin wees E E E E E E E een ankeren 47
34. Confirm the Reminder by pressing OK Once you ve confirmed the Reminder you will not be alerted again Bolus Reminders 1 From the Bolus Menu select Reminders Press OK 2 Reminder 1 field will be highlighted with a flashing cursor to indicate Edit mode Use the Up Down arrows to turn on or off Press OK to confirm and exit Edit mode 3 The Time field for this reminder will be highlighted Press OK to activate Edit mode Use the Up Down arrows to enter the time you wish a reminder to sound or vibrate if that is the setting you selected in the Setup Sound Menu Press OK to confirm your setting and exit Edit mode Page 75 4 Repeat for the Reminder 2 BOLUS MENU REMINDERS REMINDERS Reminder 12 00pm Reminders BG Check Reminder 1 From the Reminders Menu select BG Check Press OK to activate Edit mode to turn this reminder on or off Press OK to confirm and exit Edit mode Check BG Reminder BG Check EG in Last bolus 1 Hr 12 15pm Main Menu Main Menu Confirm Ee o y o 2 Scroll down to highlight the After Bolus field Press OK to select the field and activate Edit mode Use the Up Down arrows to enter how long after a Normal Bolus you wish the pump to sound or vibrate to remind you to check your BG You can select 1 2 3 or 4 hours after you give a bolus When this feature is turned on the pump will display the BG reminder screen immediately following a Normal Bolus You can change the Reminder
35. D ABOVE ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES REMEDIES AND CONDITIONS WHETHER ORAL WRITTEN EXPRESS STATUTORY OR IMPLIED TO THE EXTENT PERMITTED BY APPLICABLE LAW ANIMAS DISCLAIMS ALL IMPLIED AND STATUTORY WARRANTIES INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE IF IMPLIED WARRANTIES CANNOT BE DISCLAIMED THEN SUCH WARRANTIES ARE LIMITED IN DURATION TO THE DURATION OF THIS WARRANTY Any recovery is limited to the original purchase price No other person is authorized to modify this limited warranty Some states do not allow limitations on how long an implied warranty lasts or exclusions of incidental or consequential damages so the above limitations may not apply to you This warranty gives you specific legal rights and you may have other rights which vary from state to state ANIMAS INSULIN PUMP MAINTENANCE PARTS WARRANTY LIMITED PRODUCT WARRANTY FOR INSULIN PUMP MAINTENANCE PARTS Battery Caps Cartridge Caps etc Your Animas insulin pump maintenance part is warranted against defects in materials and workmanship for a period of SIX 6 MONTHS from the date of original retail purchase If a defect exists Animas Corporation at its option and to the extent permitted by law will 1 repair the product at no charge using new or refurbished parts 2 exchange the product with a functionally equivalent product that is new or refurbished or 3 refund the original purchase price This warranty
36. HN 5 The category list is displayed Cereals in this example To move from page to page scroll to the backward or forward arrows and press OK 6 Scroll up to select desired food item Press OK Note To return to the Food List to select a different category scroll up to highlight List and press OK Cheerios Cheerios Cheerios Carbs g j i i i 7 The food item detail screen is displayed showing nutritional information and standard serving size The Servings field is highlighted Use the Up Down arrows to enter your serving size Press OK Page 69 8 Add Item is highlighted If you wish to add an item to your meal press OK The Food List is displayed Follow steps 3 through 7 until you have added all your meal items maximum of 9 items can be entered for one meal Food List milk skim 12 9 When you enter the serving size for the last food item press OK Add Item is highlighted Use the Down arrow to scroll to Total Press OK ezCarb Total ezCarb Total Carbs Actual C 1U Food List 151 g Review Total MAX Carbs 999 g Add BG Show Result Main Menu 10 The ezCarb Total screen is displayed Review the items and carb amounts If you ve entered more than 5 items scroll to the forward arrow and press OK to see the second page of your meal list Done is highlighted Note The max limit for ezCarb Total is 999g If your meal total is more than 999g the pump display will show the actual tot
37. IN MENU REWIND MOTOR infusion set from your body Prime Rewind O Fill Cannula Go Rewind ZE 2 From Main Menu select Prime Rewind 3 On ezPrime Menu Rewind is highlighted Press OK The Rewind Motor screen is displayed REWIND MOTOR Disconnect infusion set Please wait from your body Full rewind required Go Rewind 4 Scroll up to Go Rewind Press OK The pump will rewind the piston rod 5 When the rewind action is complete the Rewind Complete screen is displayed The pump will beep once to let you know the rewind is complete Note If using a partially filled cartridge you can select Stop during the Rewind Active function to stop the rewind at the position desired Periodically the pump is required to do a Full Rewind and will not offer the option of selecting the Stop position A Full Rewind is always required when a battery is inserted 6 Insert your filled cartridge 7 Secure cartridge compartment cap to pump by turning in a clockwise motion until finger tight but do not over tighten Page 32 gt Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body Doing so while the infusion set is connected to your body can result in unintended delivery of insulin which can result in serious injury or death ezPrime Load Cart Note If screen display has timed out while loading your cartridge select Prime Rewind from Main Menu and highlight Load Cart
38. K button The Fill Cannula screen is displayed 13 Use the Up Down arrows to enter the amount of insulin needed to bolus to fill the cannula Refer to the Instructions for Use included with your infusion set for details on how much insulin is required to fill the cannula ezPrime Note The maximum Fill Cannula amount is 1U at a time Pump suspended Priming is Disabled gt The Fill Cannula step is not required for the pump to operate For example when you prime the pump after a battery change and you are not inserting a new infusion set this step is not necessary Filling the cannula when not necessary can result in Rewind unwanted delivery of insulin If the pump is suspended the screen will alert you with the ezPrime Pump Suspended screen You must resume delivery of your pump in order to complete the Priming function Selecting the Infusion Site and Inserting the Infusion Set Your healthcare team will review appropriate site selections and techniques for insertion based on your body type Refer to the Instructions For Use included with your infusion set for proper insertion guidelines gt Do NOT attempt to insert the infusion set into your body until you have been trained by your diabetes educator Improper insertion of your infusion set can lead to death or serious Injury Changing the Cartridge and Infusion Set Cartridges and infusion sets require replacement and are not to be reused Infusion sets should be
39. OK when setting is made 5 To move to the next I C Ratio screen scroll to the forward arrows and press OK Page 58 6 Scroll up to the time field and press OK to change to flashing cursor for Edit Mode 7 Use the Up Down arrows to change the segment start time Press OK 8 Scroll to the grams field and press OK to change to flashing cursor for Edit mode 9 Use the Up Down arrows to change the grams field as desired Press OK Repeat to set remaining segments per your healthcare 2 of 12 team s recommendations To review your settings highlight the forward arrows and press OK to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press OK to return to the Setup Adv screen To return to the Home screen scroll to Home and press OK Setup Advanced 7 Personal Settings Insulin Sensitivity Factor ISF Your healthcare team may recommend you use different Insulin Sensitivity Factors for different times of day When you use the ezCarb feature or ezBG your pump will automatically select the ISF for the current time of day This screen allows you to e Set different ISF s for 12 different time slots Note If you set only one ratio it will be used for the entire 24 hour period From the Setup Adv 7 screen scroll up to ISF Press OK 1 The first segment always starts at midnight The last time slot available is 11 30pm SETUP ADV Use the Up Do
40. Take rapid acting insulin by injection Page 90 Problems with Infusion Sets and Sites A number of problems can occur with infusion sets and sites the most common of which are listed in the following table along with some suggested solutions Infusion Sets and Sites Suggested Solution Air bubbles in tubing Always fill your pump cartridge with room temperature insulin Check Luer lock connection and tubing change infusion set if needed If using a disconnect set remove the set from your infusion site and prime the bubbles out Check that cartridge plunger is straight and the cartridge is not filled with more than 2 0 mL of insulin Kinked tubing Straighten tubing if needed replace infusion set if needed Dislodged needle or cannula Change infusion set and site Consider using different tape dressing or infusion set A cannula cannot be pushed back into skin successfully Blood in tubing insulin looks Change infusion set and site Check needle cannula angle at new pink or red infusion site Insulin leak Check Luer lock connection by wrapping a tissue around it to check for moisture tighten or change cartridge and infusion set if needed Check that cartridge is not filled with more than 2 0 mL of insulin Redness tenderness lumps Change infusion set and site use clean technique Treat old site itching warmth discharge for infection if necessary Consult healthcare team Cartridge Reused Do not reuse cartridge Cartridge is
41. Total Daily Doce TDD History sisspsisrrisrieiisseronrinrrrraiinri kriantan ariin iin indenken 48 AETS O ee A E E E E EE S sores 48 Powe TO T e EAA T E E E EO 49 ASPENA NS ONY aeee ra AEE EE EEEE E EE NE 49 Baa OI e A A snee eener nende 50 Chapier 10 Status Podl ag ccs ce ce innn en ENEE EEEE E OEE 51 Status Screen 1 Active Basal ccusecenrenctacisetimauneeentanwise eene ea saie 51 Status Screen 2 Last BOLUS seriis rsrscrerinsokuusedieie ta neq nase suave nikaren erin iine asn 51 Status Screen 3 Delivery Today eesssssessesseesessorseescecescsseesersersocsseesersceserseeeceesessee 52 Dials Screen 4 GOMDO BOLUS censeaeceannecoccaeverescacuesnenecotwaceu bearers EN EEE E nent 52 Saus Sereen D EMP o 1 E A E E E T EE E 52 SIRURI E A E E E EE EEEE 53 Chapter 11 Advanced Features Setup and Activation cccccececececcscececececcececececeecs 55 Setup Advanced 1 Audio Bolus Feature ccccccscececsccscstscececcececececcesetecececcecececs 55 Setup Advanced 2 Advanced Bolus Features and Multiple Basal Programs 56 Setup Advanced 3 Insulin Limits seesseeseesseesseescersosrsccsscesecssecesocssceseossseesocsseeeee 56 Setup Advanced 4 Language Setup Display Timeout Contrast and Battery Type 57 Setup Advanced 5 Auto 0FF Feature ssesssssesseecsceerosssecsecesccsscssscesecssccesosssceeseeesee 57 Setup Advanced 6 Low Cartridge Warning Setting and Occlusion Sensit
42. a Temp Basal running but stopped exercising early How do I stop the Temp Basal From the Basal Menu select Temp The Temp Basal details are shown Scroll to Cancel and press OK 6 How do I find out how much insulin has been delivered in a currently active Combo Bolus From the Bolus Menu select Combo The current details of the Combo Bolus are displayed 7 Td like to use the ezCarb feature but I don t know what my Insulin to Carb ratios are for different times of day Consult with your healthcare team for information regarding your personal plan of treatment 8 How do I know if my ezManager software is compatible with the model pump I have When you install ezManager software go to the Communication or Download feature Check the drop down box for pump models If your pump model is not listed please call Customer Support at 1 877 767 7373 Outside the US Canada and Puerto Rico contact your local Animas distributor Page 103 Page 104 Glossary alpha cells Alpha cells are found in the pancreas They produce a hormone called glucagon which raises blood glucose levels basal rate The basal rate is the amount of insulin that is continuously delivered by an insulin pump It is measured in units per hour U hr The basal rate usually provides about 40 to 60 of the daily total delivery of insulin beta cells Beta cells are found in the pancreas They produce insulin which lowers blood glucose levels In Type 1
43. ady P N 410 055 00 Rev F Company Duracell is a trademark of Procter amp Gamble Rev Date 06 2009
44. al and the max amount The ezCarb Home screen will use the max number for the calculator and will show the Actual total in parentheses Page 70 11 Review the items and carb amounts With Done highlighted press OK 12 The ezCarb Home screen is displayed with the total carb amount displayed in the carbs field Proceed as outlined in the two previous sections Carbs Actual l C 1U a If entries are correct proceed as outlined in the two Food List previous sections Review Total b If entries are not correct see next section Editing ezCarb Add BG Show Result Total entries 13 To review your meal from the ezCarb Home screen scroll to Review Total and press OK Editing ezCarb Total Entries 1 From the ezCarb Total screen scroll up to highlight the food item you wish to edit Press OK 2 The food item detail screen is displayed with the cursor flashing to indicate Edit mode Use the Up Down arrows to change the Servings field to the desired amount Scroll to Total Press OK The ezCarb Total screen is displayed ezCarb Total ezCarb Total Item Carb g l 3 milk skim 24 Total o g MAX Carbs 999g MAX Carbs 999g dd Item Done Ke sd Add Item Done Note To delete an item change the serving size to 0 It will be deleted from the ezCarb Total 3 Done is highlighted Press OK to return to the ezCarb Total screen 4 Proceed as outlined in the two previous sections Page 71 ezBG This feature all
45. amount below 70 mg dL or above 250 mg dL your pump will alert you that you ve entered an out of range BG To Confirm the Alert press OK Treat the out of range BG as recommended by your healthcare team HIGH BG Treat high BG LOW BG Treat low BG Check site Check ketones Monitor BG Confirm mmm No Bolus recommended Monitor BG Page 73 Combo Bolus The Combo Bolus feature is used to give both a Normal and Extended Bolus This feature is useful for consumption of high fat meals such as pizza if you will be grazing over a few hours or if you have gastroparesis You can program part of your bolus amount to be delivered immediately and part of it to be delivered slowly over the course of up to 12 hours Your healthcare team can help you determine the split of Normal to Extended insulin amounts as well as the duration that is most appropriate for you 1 From the Bolus Menu select Combo Bolus BOLUS MENU Normal ezCarb eZBG Combo Bolus Normal Extend 0 100 0 00 0 00 U Combo Bolus Reminders 2 Use the Up Down arrows to enter the TOTAL bolus amount Press OK Go is highlighted The factory default setting for Duration is 30 minutes and the ratio is 0 Normal and 100 Extended If these settings are appropriate press OK to deliver Combo Bolus Combo Bolus Normal Extend Normal Extend 30 70 30 70 2 55 5 95 U 2 55 5 95 U n 3 To change either the Duration or Rat
46. an also use your computer and ezManager software to upload settings for Advanced Setup Refer to the ezManager User Guide included with the software From the Setup Menu select Advanced and press OK MAIN MENU SETUP Advanced Setup Advanced 1 Audio Bolus Feature This screen allows you to e Turn Audio Bolus on or off SETUP ADV 4 e Select the Audio Bolus delivery step size AUDIO BOLUS o 0 1 0 5 1 0 5 0 Units Use the Up Down arrows to scroll to the desired field Press OK to change to flashing cursor for Edit mode Use the Up Down arrows to change to desired setting KR OW PO fe Press OK when setting is made Note If Audio Bolus is activated the shortcut to ezBolus will be deactivated You can still give a Normal Bolus via the Main Menu To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK For more information see Chapter 12 Using Advanced Features Page 55 Setup Advanced 2 Advanced Bolus Features and Multiple Basal Programs This screen allows you to e Turn Advanced Bolus Features on or off BOLUS o ezCarb Bolus Adv Bolus o ezBG Bolus Reminders o Combo Bolus Eeen e Turn personal Reminders feature on or off BASAL e Select bolus delivery speed normal 1 U every second or slow Programs 1 U every 4 seconds e Select either 1 basal program or 4 basal programs to be displayed i
47. anced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK Note The Low Cartridge Warning only alerts you one time For example Delivery if you have it set to 30U and receive an alert and then change REN the setting to 20U it will not alert at 20U until after the next cartridge dueto has been primed If a bolus is delivered which causes a Low Cartridge low Warning your remaining insulin may be less than the Warning screen cartridge displays If a delivery amount exceeds the low cartridge setting a Warning will be displayed and the delivery is canceled Setup Advanced 7 Personal Settings Insulin to Carb 1 C Ratios Your healthcare team may recommend you use different Insulin to Carb ratios for different times of day When you use the ezCarb feature your pump will automatically select the I C ratio for the current time of day odd The 1 C Ratio screens allows you to l C Ratio e Set different I C ratios for 12 different time slots Note If you set only one ratio it will be used for the entire 24 hour period From the Setup Adv 7 screen scroll up to I C Ratio Press OK 1 The first segment always starts at midnight The last time slot available is 11 30pm Use the Up Down arrows to scroll to the grams field 2 Press OK to change to flashing cursor for Edit Mode 3 Use the Up Down arrows to change to desired setting 4 Press
48. and amount of last bolus o N Normal o C Combo o A Audio e Time and date of last bolus STATUS 1 ACTIVE BASAL A 1 WEEKDAY 24 Hr Total 13 60U 0 675U Hr Insulin 105U STATUS 2 IOB 1 70U LAST BOLUS N 3 30U 9 55AM Jul 8 2003 Main Menu The cursor is flashing on the Status Screen number 2 Press the Up arrow to move to Status Screen 3 or press OK to highlight Main Menu and exit Status screens Page 51 Status Screen 3 Delivery Today The screen displays the following information STATUS 3 e Insulin type DELIVERY TODAY e If Temp Basal has been active between midnight and today s current time e If Suspend has been active between midnight and today s current time e Total bolus amount delivered since midnight and up to today s current time e Total basal amount delivered since midnight and up to today s current time e Total insulin delivered excluding prime amounts since midnight and up to todays current time The cursor is flashing on the Status Screen number 3 Press the Up arrow to move to Status Screen 4 or press OK to highlight Main Menu and exit Status screens Status Screen 4 Combo Bolus The screen displays the following information STATUS 4 e Most recent Combo Bolus that was used COMBO BOLUS e Most recent Combo Bolus status CANCELED o Active or Completed or Canceled Start time O o End time o Amount delivered if active shows amount delivered as 3 28 9 00U of current time Fo
49. answering machine or cell phone is prohibited A supplier must have comprehensive liability insurance in the amount of at least 300 000 that covers both the supplier s place of business and all customers and employees of the supplier If the supplier manufactures its own items this insurance must also cover product liability and completed operations Failure to maintain required insurance at all times will result in revocation of the supplier s billing privileges retroactive to the date the insurance lapsed A supplier must agree not to initiate telephone contact with beneficiaries with a few exceptions allowed This standard prohibits suppliers from calling beneficiaries in order to solicit new business Page 115 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 A supplier is responsible for delivery and must instruct beneficiaries on use of Medicare covered items and maintain proof of delivery A supplier must answer questions and respond to complaints of beneficiaries and maintain documentation of such contacts A supplier must maintain and replace at no charge or repair directly or through a service contract with another company Medicare covered items it has rented to beneficiaries A supplier must accept returns of substandard less than full quality for the particular item or unsuitable items inappropriate for the beneficiary at the time it was fitted and rented or sold
50. ate the feature For example Audio Bolus Sound is adjusted in this menu but to turn the Audio Bolus feature on go to the Setup Advanced Menu See Chapter 11 Advanced Features Setup Advanced 1 Audio Bolus Feature Your pump comes pre loaded with a tune for most Alerts Reminders and Alarms This tune plays only for the initial audible notification If you do not confirm the initial notification the next sound will be the factory default If not confirmed Warnings and Alarms will automatically progress to high volume and vibrate within one hour With ezManager you can change or add tunes to play as your initial notification for some Alerts Reminders Warnings and Alarms Refer to your ezManager User Guide included with the software Page 28 Normal Bolus Sound Audio Bolus Sound OFF is not an option for this sound setting Temp Basal Sound These are the options from the first Setup Sound Menu They can be set to one of the following Vibrate Low volume Medium volume High volume or can be shut off completely For safety reasons some of the alerts cannot be turned off MAIN MENU SETUP SETUP SOUND H Alert Sound Reminder Sound Warning Sound OFF is not an option for this sound setting Alarm Sound OFF is not an option for this sound setting These are the options from the second Setup Sound Menu They can be set to one of the following Vibrate Low volume Medium volume or High volume For safety reasons some of
51. be reported to the National Supplier Clearinghouse within 30 days An authorized individual one whose signature is binding must sign the application for billing privileges A supplier must fill orders from its own inventory or must contract with other companies for the purchase of items necessary to fill the order A supplier may not contract with any entity that is currently excluded from the Medicare program any State health care programs or from any other Federal procurement or nonprocurement programs A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment and of the purchase option for capped rental equipment A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law and repair or replace free of charge Medicare covered items that are under warranty A supplier must maintain a physical facility on an appropriate site A supplier must permit CMS or its agents to conduct on site inspections to ascertain the supplier s compliance with these standards The supplier location must be accessible to beneficiaries during reasonable business hours and must maintain a visible sign and posted hours of operation A supplier must maintain a primary business telephone listed under the name of the business in a local directory or a toll free number available through directory assistance The exclusive use of a beeper
52. but prevents water from getting inside Cartridge Cap Primary Vent gt Under no circumstances should you introduce any kind of sharp object into the vent openings to clean them Doing so will compromise the pumps waterproof capabilities If at any time you suspect the vent openings are clogged replace the battery cap or call Animas for questions about the Primary Vent Battery Cap Vent Page 22 Cartridge Compartment Cap This cap secures your cartridge and infusion set in the pump gt Never tighten the cartridge cap when your infusion set is attached to your body Tightening the cartridge cap while your infusion set is attached to your body may result in unwanted insulin delivery IR Window for Download Animas IR 2020 INSULIN PUMP g 24 7 PUMP SUPPORT The IR window is framed in blue This is the IR Window 877 767 7373 infrared communication window used for Ipm 1 877 YES PUMP downloading your pump data SIN 49 00015 10 Sounds OEEEEKEEKEEEELELKEEKEEDELD TT OND Your Animas 2020 allows you to customize the volume level or use the vibrate function to notify you of warnings and alarms and to confirm certain deliveries With ezManager you can also add tunes to play as your initial audible notification for some Alerts Reminders Warnings and Alarms Refer to your ezManager User Guide included with the software Tamper Resistant Locked Feature You can use the tamper resistant feature t
53. by pressing any button on the front panel of the pump by user The Warning screen shown here will be displayed Confirm button the Warning by pressing OK and check your Bolus History press for the amount delivered Page 35 Note You can check when you last gave a bolus by looking in History or Status These features are covered later BOLUS MENU Note If you have Advanced Bolus features and Reminders turned on the Bolus Menu at right will be displayed when you select Bolus Combo Bolus from the Main Menu Select Normal and press OK Follow steps 2 Reminders through 4 in this section Page 36 Chapter 7 Using Basal Program Features You can program your Animas 2020 to display either 1 or 4 basal program options Basal insulin is delivered continuously to help keep your blood glucose in target between meals Having more than one pre set basal program makes it easy for you to switch based on your weekday needs versus weekend needs or to accommodate for shift work and menstruation If you are new to pumping your healthcare team may suggest you first become comfortable with one program before using multiple basal programs The factory default displays one basal program and the temporary basal program To display multiple basal options see Chapter 11 Advanced Features You can use your computer and ezManager software to upload basal program names as well as basal rates Outside the US check with your local Animas distributor f
54. cally resume the active basal program Note If you turned on the Temp Basal sound in Setup the pump will beep once every 30 minutes to remind you of Temp Basal status Canceling a Temporary Basal Program 1 From Basal Menu select Temp Basal Press OK 2 Details of the current active Temp Basal program will be displayed Scroll up to Cancel and press OK Your previously active basal program will be activated and the Home screen will be displayed to show the current rate per hour of the active basal program Note If you Suspend your pump while a Temp Basal program is active the Temp Basal program will be canceled and an Alert screen will notify you that the Temp Basal program has been canceled This Alert is displayed once and gives an audible tone once if you turned on Alert sounds in Setup Temp Basal is also canceled when you change the battery and or prime A 1 WEEKDAY 0 675 U Hr 40 If active 0 405 U Hr Temp Basal amp Time left Combo Bolus 1 2 Hr have been CANCEL canceled Page 43 Page 44 Chapter 8 Suspend Resume Feature This feature allows you to stop basal insulin delivery quickly and easily It also cancels delivery of any Temp Basal or Bolus including Combo Bolus that may be currently active The Combo Bolus feature is covered later in this User Guide Suspending Delivery 1 From the Main Menu scroll to Suspnd Resum 2 Suspend is highlighted Press OK gt The screen will display
55. ctivated Advanced Bolus features the Bolus Menu will be displayed Here you can select bolus options program and activate your bolus dose Consult your healthcare team for your personal settings for calculations of food and correction boluses Suspend Resume The Suspend function stops all insulin deliveries and Resume restarts basal delivery History This option allows you to review history of boluses total daily dose TDD alarms primes suspend and basal information Basal The Basal Menu allows you to access and program your 24 hour basal rate This continuous rate maintains your blood sugar between meals This rate will be calculated by your healthcare team The default Basal Menu will display one basal program and the Temp Basal option You can activate additional basal program options with the Setup Advanced Menu Setup This menu allows you to personalize the settings and features of your Animas 2020 as well as add advanced features to the menu Your healthcare team will advise you on which features are best suited for your plan of treatment as well as train you to achieve the best results Prime Rewind This function enables you to properly align the cartridge and piston rod as well as prime your infusion set tubing before connecting to the pump Status This feature allows you to quickly see your current most recent settings and pump deliveries Page 24 Chapter 5 Getting Your Pump Ready gt Before proceeding with
56. d reviewing press OK to exit Review Mode 5 History Menu is highlighted Press OK to return to History Menu History Menu gt The History records each basal rate change When no basal is being delivered the Basal History Record will show 0 units delivered This can happen for the following reasons Cartridge change Battery change Suspend Alarm Basal segment set to 0 Basal edit screen accessed Prime menu accessed Loss of prime Page 50 Chapter 10 Status Feature This feature gives you easy access to a summary of information about your pump s current programming and performances There are 6 Status Screens 1 From the Main Menu or from the Home screen scroll to Status and press OK _ MAINMENU MAIN MENU 2 27 pm Basal Rate 0 025U Hr Insulin 105U Status Status Home Status Screen 1 Active Basal The screen displays the following information e Which basal program is currently active e The 24 hour total for the active basal program e Units per hour currently being delivered e Insulin currently remaining in cartridge The cursor is flashing on the Status Screen number 1 Press the Up arrow to move to Status Screen 2 or press OK to highlight Main Menu and exit Status screens Status Screen 2 Last Bolus The screen displays the following information e Amount of insulin currently on board IOB For more information on this feature see Chapter 11 Advanced Features e Type
57. e you want to clear all the segments of the basal program selected The Alert screen shown here is displayed If you do wish to clear all the basal segments of the selected program scroll to Clear Program and press OK Clear Program If you do NOT wish to clear all the basal segments scroll to Basal deletes all Options and press OK The Basal Options screen will be displayed basal segments in this program If all segments of your active basal program are set to 0 000 U hr the pump will not deliver any basal insulin Each time you wake up the pump the Alert screen shown here is displayed If you have Basal Options turned on the sound for Alerts you will also be notified by a beep or vibrate This Alert screen does not need confirmation and does not progress to higher audible alarms You do have the option to either Your active select Confirm to quickly go to the Main Menu screen or select Basal basal Menu to reset rates in your active program For more information see Sorel is emp Chapter 14 Safety System and Alarms 0 000 U Hr Confirm Temporary Basal Feature This feature allows you to increase your active basal delivery rate for events such as sick days or decrease for events such as exercise You can set in decrements of 10 down to 90 or in increments of 10 up to 200 You can also set to OFF You can set the duration up to 24 hours in half hour increments If you have activated multiple basal programs in Setup Advanced
58. e the default contrast level as well as perform the function of the key To adjust contrast during a Call Service alarm you must use the contrast button See Chapter 11 Advanced Features Setup Advanced s4 Contrast Adjustment and Display Timeout Setting Note When viewing the pump display in bright sunlight it is recommended you shade the screen or move to a shady area for best visibility Audio Bolus ezBolus This button allows you to program a bolus without looking at the pump by using audible tones to confirm programming and delivery If you choose not to activate the Audio Bolus feature this button provides a shortcut to the Normal Bolus screen When you first use the Audio Bolus feature you should always look at the screen to confirm correct programming until you are comfortable with using audio feedback to program a bolus See Chapter 11 Advanced Features Setup Advanced 1 Audio Bolus Feature Battery Cap Vent This cap unscrews easily with a coin to replace and secure your battery There is a yellow o ring around the cap which prevents water from entering The battery cap also is equipped with a built in vent to allow air to enter the pump to maintain pressurization but prevent water from entering Be careful not to over tighten the battery cap See Chapter 5 Changing the Battery Primary Vent This vent is part of the redundant vent safety system which allows air inside the pump to maintain equalized pressure
59. e body in turn burns muscle and fat for energy A waste product of fat burning is ketones Ketones accumulate in the blood and then pass through the urine and lungs This condition can be identified by urine and or blood tests DKA usually requires hospitalization and can be fatal if not promptly treated gastroparesis Gastroparesis is a complication of diabetes that causes delayed digestion resulting in unpredictable swings in blood glucose levels Page 105 gestational diabetes Gestational diabetes is a form of diabetes that may develop during pregnancy In some women certain hormones normally produced by the body during pregnancy can result in unusually high blood glucose levels If the body cannot produce enough insulin this can lead to hyperglycemia and may require treatment with insulin Gestational diabetes usually ends when the baby is born but many mothers who experience gestational diabetes can later develop Type 2 diabetes glucagon Glucagon is a hormone produced by the alpha cells in the pancreas It causes blood glucose levels to rise glucose Glucose is a carbohydrate and the body s most important source of energy It is produced from digested food by the normal action of the liver and is carried by the blood throughout the body hyperglycemia Hyperglycemia is also known as high blood glucose It occurs when blood glucose levels rise above 180 mg dL 10 0 mmol L and the body does not have enough or cannot use in
60. e event of interruption of pump therapy Extra infusion sets and 2 0 mL Cartridges 200 unit 2ml Dressing and adhesive if used An extra Energizer Lithium L91 AA battery An extra pump battery cap Page 9 e An extra pump cartridge cap In the US Canada and Puerto Rico call 877 937 7867 to order an extra cartridge cap All other customers contact your local Animas distributor e Glucagon Emergency Kit e Emergency contact phone numbers Be sure to inform a family member co worker and or friend where this emergency kit is kept Indications for Use The Animas 2020 insulin infusion pump is intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients Contraindications The pump is not indicated for anyone unable or unwilling to e Test BG levels at least 4 6 times per day or as recommended by healthcare team e Demonstrate adequate carbohydrate counting skills e Maintain good diabetes self care skills e See his her healthcare team regularly Adequate vision or hearing is required to recognize the pump alerts Warnings and Precautions gt Radiology Equipment Your Animas 2020 has been designed to operate in the presence of common sources of electrostatic and electromagnetic interference including airport and store security systems However like all portable electronic devices the pump should not be exposed to very strong electr
61. e too high or too low can adversely affect blood glucose levels Work with your healthcare team to fine tune basal rates gt The way your body uses insulin can be affected by many things Contact your healthcare team about lifestyle changes such as starting stopping your exercise program or significant weight loss gain Your basal rates may need to be modified gt DO NOT stop using the pump if you are ill Even when youre sick your body still needs insulin See Chapter 16 Sick Day Guidelines gt When you begin using the Audio Bolus feature always look at the screen as you program so that you are completely comfortable with the feature before delivering a bolus via audio prompts only gt Animas Corporation recommends that you have someone around you family friends etc who understands diabetes and pump therapy so in the event of an emergency they can help you Be sure they are familiar with any information given to you by your healthcare team gt The Animas 2020 and accessories include small component pieces that could pose a choking hazard to small children gt Before Bedtime gt To ensure proper delivery do not change your infusion set just before bedtime or if you will not be able to test your blood glucose 1 to 2 hours after a new set is placed gt Always check that your cartridge has enough insulin to last through the night before going to bed Unless otherwise recommended by your healthcare team do not u
62. eben meren aem 95 Exercise ANG SONS aenveror raar A ETE EEE A ATE 95 SWL MENG entente dekensers tanden ouneteenscodetensnss Ierse neten end eden ene 95 LEVEN eaa E E A EE E E A E 95 PTY UI gE 96 Chapter 18 My TOM LOT se sncncocccncsvonesosauncticsnceseonsagesecneesancocendonanenseneuesaaneasaeeansusenens 97 Frequently Asked Questions BAGS renners kerende e aS EEE rA Ea NE 103 GOS r E E EE E 105 Technical Specifications for the Animas 2020 ssssssssssscessseesccsseescceseeesocsseeseceseeeseeee 109 Ammas muun Pomp Wail aniy ssnteensesbrerssnndeknesnenteomn nemers snake seinen 111 ANIMASS INSULIN PUMP ACCESSORY WARRANTY waccccncscucscccdncsentaconvesieosaeimedeuserencacanens 112 ANIMAS INSULIN PUMP MAINTENANCE PARTS WARRANTY cccsceceesececececscececeeecs 112 Patient Bill of Rights and Responsibilities cscscscscscscececececececececececesesescscscececeseees 113 DL DET NA S a EE EEE E EE E E EA E ERES 115 Page 5 Page 6 Welcome and Congratulations You have begun a new way of life with your Animas 2020 insulin pump Your choice of pump therapy is a sign that you are committed to taking excellent care of yourself The Animas 2020 pump has been specially designed to help you manage your diabetes using advanced technology and sophisticated safety systems Your pump is used for insulin therapy to help maintain your blood glucose targets as recommended by your healthcare team You program it to deliver two way
63. eed 0 5 to 0 9 U sec e Bolus 1 U or more slow delivery speed 0 2 to 0 4 U sec e Prime 1 8 to 2 9 U sec Insulin Types Used Rapid acting U 100 insulin or regular short acting U 100 insulin Basal Rate Range 0 025 25 U hr in 0 025 U hr steps Bolus Range 0 05 35 U in 0 05 U steps Protection from equipment error More than 1 5 million redundant safety cross checks per day for both hardware and software functionality Page 110 Animas Insulin Pump Warranty Animas warrants that the Animas insulin pump will be free from defects in material and workmanship for a period of four 4 years from the date of purchase by the original purchaser This limited warranty extends only to the original retail purchaser If during the warranty period the pump should fail because of a defect in material or workmanship it may be returned to Animas and Animas will repair or replace your pump with a new or recertified pump at Animas option without charge to the purchaser In certain circumstances and at its sole discretion Animas may instead elect to refund all or a portion of the purchase price of the pump to the purchaser Freight and transportation charges where applicable incurred in shipping a pump to be repaired or replaced under this limited warranty will be paid by Animas In the event a pump is replaced or repaired under this warranty the warranty period shall not be extended Once you have received your repaired or replaced pump you mu
64. eekday is active you cannot change this setting to display 1 basal program The Alert screen shown here will active program to change the pop up to remind you basal display setting Confirm Insulin on Board BOLUS TOTAL Even with rapid acting insulin your body takes some time to use the entire bolus amount If you have activated this feature your pump will track the bolus insulin remaining in your system Insulin on Board IOB and calculate a suggested lower correction bolus dose The lower dose is only recommended if you use the ezBG feature or if you add a BG bolus to an ezCarb bolus For this feature to give optimal results you should always use either ezBG or the Add BG feature during ezCarb programming when entering a correction bolus gt Your healthcare team will give you recommendations specific to your plan of treatment In the examples shown here IOB amount is subtracted from the Bolus Total screen and the ezBG Total screen gt When you replace the battery the IOB amount is cleared Note The pump constantly tracks insulin on board If you ve given a bolus before turning on the feature the pump will show the remaining amount from that bolus as IOB immediately Page 77 Sick Day Guidelines SETUP ADV Sick Days To review your basic sick day guidelines refer to this screen For more information on sick day guidelines refer to Chapter 16 Sick Day Guidelines and contact your healthcare team
65. een is displayed The bolus amount field is highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed Enter your bolus amount Press OK 6 Go is highlighted If you wish to give a Normal Bolus press OK to deliver BOLUS TOTAL BOLUS TOTAL BOLUS TOTAL DELIVERING Press any function button to Cancel 7 If you wish to give a Combo Bolus scroll to the Type field and press OK to edit 8 Use the Up Down arrows to select bolus type Normal default or Combo Press OK 9 Go is highlighted Press OK Note If you select the Combo Bolus option the Combo Bolus menu will be displayed See this chapter Combo Bolus Adding a BG Bolus to ezCarb 1 On the ezCarb Home screen enter the number of carbs Press OK 2 Add BG is highlighted Press OK The BG Correct screen is displayed 3 The Actual field is highlighted and flashing to indicate Edit mode Use the Up Down arrows to enter your BG value Press OK Show Result is highlighted BG CORRECT BG CORRECT Show Result 4 Check that the BG target and Insulin Sensitivity Factor ISF are correct a If they are correct press OK with Show Result highlighted b If they are not correct scroll up to highlight the fields and press OK Use the Up Down arrows to adjust the values Press OK to exit Edit mode Scroll down to Show Result Press OK BG CORRECT BG CORRECT Page 67 BOLUS TOTAL BOLUS TOTAL Main Menu Main Menu 5
66. end Exercise START TIME Page 98 Basal Programming Date SEGMENT Program 1 Program 2 Program 3 Program 4 Weekday Weekend Exercise START Page 99 Basal Programming Date SEGMENT Program 1 Program 2 Program 3 Program 4 Weekday Weekend Exercise START Page 100 Basal Programming Date SEGMENT Program 1 Program 2 Program 3 Program 4 Weekday Weekend Exercise START Page 101 Page 102 Frequently Asked Questions FAQs 1 The Wake up screen shows my current basal rate delivery but doesn t show which Basal Program is active How do I find this information From the Wake up screen use the Up Down arrows to highlight Status and press OK Status Screen 1 shows the name of the active basal program 2 When I go to Status Screen 2 there is an IOB Insulin on Board amount shown but I don t use this feature The pump tracks IOB constantly and will show the amount on the Status Screen 2 even if you dont have the IOB feature turned on 3 The Audio Bolus feature isn t working When I press the Audio bolus button the Normal Bolus screen appears You must first turn on the Audio Bolus feature in Setup Advanced If Audio Bolus is not turned on this button is a short cut to the Normal Bolus screen 4 I can t get the cartridge to go in all the way When loading a cartridge you must first rewind the pump s piston rod and then load the cartridge See Chapter 5 Getting Your Pump Ready 5 I have
67. ents without regard to race color national origin religion sex age or disability No person shall be excluded from participation in or be denied the benefits of any service or be subject to discrimination because of race color national origin religion sex age or disability It is the responsibility of all Animas employees involved in interaction with the patient through sales education programs customer service or any other means to understand and promote this policy It is the responsibility of patients of Animas Corporation to actively participate in his or her care The patient is given information to allow decision making regarding care or services The patient is responsible for providing accurate and complete information about his or her health and medical conditions The patient is involved in conflict resolution The patient should inform Animas about his or her expectations and satisfaction with care Patient complaints will be heard reviewed and resolved to the best of our ability The patient should ask questions when they do not understand his or her care treatment services or what they are expected to do The patient should follow the treatment plan or contact his or her health care professional if unable to do so The patient should also express any concerns about his or her ability to follow the instructions and should report changes in his or her condition as appropriate If they do not follow the instructions the
68. ere temperatures are between 40 and 104 F 5 40 C If your pump is exposed to temperatures outside these parameters extra care should be taken to protect it from extreme temperatures Animas insulin pumps and insulin pump cartridges are latex free To avoid risk of explosion do not use the pump in the presence of explosive gases Your Animas 2020 pump is designed to achieve optimum performance and battery life with an Energizer Lithium L91 AA battery 1 5V Rechargeable batteries and Carbon Zinc batteries do not have the necessary characteristics to power the pump and should not be used Some AA lithium batteries are available with other voltages such as 3 6V or 4 0V Do not use these batteries Use of anything other than a 1 5V battery could permanently damage the pump and voids its warranty Do not use household cleaners chemicals solvents bleach scouring pads or sharp instruments to clean the pump Never put your pump in the dishwasher or use very hot water to clean it Never use a hair dryer microwave oven or baking oven to dry your pump Use a soft towel Page 16 Chapter 2 Package Contents Take a minute to check the contents of your Animas 2020 shipping box It should include Your Animas 2020 Insulin Pump One Energizer Lithium L91 AA battery 1 5V A User Guide Low Profile Clip Page 17 Page 18 Chapter 3 Explanation of Symbols Shown below are symbols you will find on your Animas 2020 insuli
69. firmed No Prime warning triggered see No Prime Page 86 Chapter 15 Troubleshooting Guidelines It s a good idea to set up a troubleshooting procedure to use anytime you suspect something might be wrong Work with your healthcare team to establish guidelines in the event of a problem Hypoglycemia Low blood sugar is a risk for anyone using insulin therapy You may experience one or more of the following symptoms gt Shakiness rapid heart rate nervousness perspiration cold clammy skin weakness blurred or double vision sudden hunger tingling in your hands lips or tongue headache and confusion gt If you experience symptoms of hypoglycemia you should immediately eat a quick acting carbohydrate glucose tablets juice or hard candy gt If your BG is abnormally low do not attempt to program the pump yourself Get help gt Treat Hypoglycemia immediately Rule of 15 Consume 15 grams of quick acting carbohydrate Wait 15 minutes Recheck BG If BG is lt 70 mg dL 3 9 mmol L repeat above Troubleshooting hypoglycemia Possible Cause of Low BG Suggested Solution INSULIN PUMP Basal rate programmed incorrectly Check times and rates remember to review basal programs when making any changes Clock time incorrect Reset clock to current time being careful to check AM amp PM Pump exposed to MRI Disconnect from pump Call Pump Support 1 877 767 7373 Outside the US Canada amp Puerto Rico contac
70. from ezPrime Menu Press OK to display Rewind Complete screen Continue rj Prime REWIND LOAD COMPLETE CARTRIDGE Be sure set is Load U 100 ACTIVE disconnected cartridge from your body Attach cap Please wait Then select Select Continue Continue Insulin 200U Continue En 8 On the Rewind Complete screen Continue is highlighted Press OK The pump will align the piston rod with the cartridge The Load Cartridge Active screen is displayed followed by the Prime screen The pump will beep once to let you know the cartridge is aligned with the piston rod PRIMING DONE Press AND HOLD Press AND HOLD OK button OK button 23 U Primed while priming while priming tubing tubing 177U Remaining Insulin 200U 9 On the Prime screen Continue is highlighted Press OK 10 The Deliver Prime screen is displayed Be sure the infusion set is not connected to your body until the prime is complete 11 Make sure Go Prime is highlighted Press and hold the OK button until you see 5 drops of insulin come out the end of your infusion set This means your tubing is primed The Priming Active screen is displayed followed by the Priming Done screen Refer to the Instructions for Use included with your infusion set for proper insertion guidelines See next section Selecting the Infusion Site and Inserting the Infusion Set Page 33 FILL CANNULA Eil Cannula 12 From the ezPrime Menu Fill Cannula is highlighted Press the O
71. from beneficiaries A supplier must disclose these supplier standards to each beneficiary to whom it supplies a Medicare covered item A supplier must disclose to the government any person having ownership financial or control interest in the supplier A supplier must not convey or reassign a supplier number i e the supplier may not sell or allow another entity to use its Medicare Supplier Billing Number A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards A record of these complaints must be maintained at the physical facility Complaint records must include the name address telephone number and health insurance claim number of the beneficiary a summary of the complaint and any actions taken to resolve it A supplier must agree to furnish CMS any information required by the Medicare statute and implementing regulations All suppliers must be accredited by a CMS approved accreditation organization in order to receive and retain a supplier billing number The accreditation must indicate the specific products and services for which the supplier is accredited in order for the supplier to receive payment of those specific products and services except for certain exempt pharmaceuticals All suppliers must notify their accreditation organization when a new DMEPOS location is opened All supplier locations whether owned or subcontracted must meet the
72. hat the individual was discriminated against In this way the appropriate person may respond to the complaint Please contact Animas Corporation if there are any questions or concerns regarding this information The Joint Commission Animas is committed to the safety and care of its patients As part of this commitment Animas is accredited by The Joint Commission which sets the standards for quality of care in the health care community If you would like to contact The Joint Commission regarding an issue you may do so by fax 630 792 5636 or mail Office of Quality Monitoring The Joint Commission One Renaissance Boulevard Oakbrook Terrace IL 60181 You will need to complete a Quality Incidence Report Form which is available from The Joint Commission Page 114 Supplier Standards Medicare regulations have defined standards that a supplier must meet to receive and maintain a supplier number The supplier must certify in its application for billing privileges that it meets and will continue to meet the standards The supplier standards can be found in 424 CFR Section 424 57 c and were effective December 11 2000 Following is an abbreviated version of the supplier standards 1 10 Al A supplier must be in compliance with all applicable Federal and State licensure and regulatory requirements A supplier must provide complete and accurate information on the DMEPOS supplier application Any changes to this information must
73. he audio bolus button Note Do NOT press any of the function buttons at this time unless you wish to cancel delivery Audio Bolus DELIVERING Confirm 3 00U Press any other Press any button key to CANCEL to CANCEL 5 Within 5 seconds the pump will beep twice to ask you to confirm that you wish to activate delivery and the Confirm screen is displayed 6 Within 5 seconds press the button again to activate delivery The pump will beep twice to confirm your delivery command The Delivering Bolus screen is displayed and your pump will beep once to signal the start of delivery and once to signal end of delivery if you turned on Normal Bolus Sounds in Setup gt If you wish to cancel the Audio Bolus press any button The bolus will be canceled as in the case of a Normal bolus Warning If you cancel a bolus delivery after you ve activated it the screen Bolus at right will be displayed delivery canceled by user gt If during a bolus delivery your low cartridge level is reached button press the pump will not display the warning until after the bolus is completed So you could possibly have less insulin available than your low cartridge setting Confirm Example Your low cartridge warning is set to 10 units You have 20 units of insulin remaining and you deliver a 15 unit bolus The Low cartridge warning appears after bolus is completed and you have only 5 units left not 10 units The Wake up screen
74. hormone produced by the beta cells in the pancreas Insulin is needed by the body to regulate the production and use of glucose insulin limits Insulin limits are a programmable feature of the ANIMAS pump After consulting with your healthcare team you can use the advanced menu to program maximum limits for basal rate delivery bolus delivery and total daily delivery Page 106 insulin pump An insulin pump is a small battery powered device that mechanically pumps measured amounts of insulin through an infusion set into the body THE PUMP IS NOT AUTOMATIC You program and control it and you must perform four to six blood glucose tests daily to ensure delivery of appropriate amounts of insulin by the pump ketones Ketones or ketone bodies are substances produced by normal liver activity and used by muscle tissue In uncontrolled diabetes the process becomes unbalanced and ketones can accumulate in the blood pass through the urine and ultimately result in diabetic ketoacidosis DKA Luer lock A Luer lock connection is a standardized specially threaded fitting used to connect the infusion set to the pump s insulin cartridge mg dL mg dL is the unit used to measure blood glucose levels It is the abbreviation for milligrams of glucose per deciliter of blood To convert mg dL to mmol L divide by 18 or multiply by 0 055 mmol L mmol L is an alternative unit used to measure blood glucose levels It is the abbreviation for
75. ical equipment is being used in the procedure For procedures not included above or on the chart on the following page call in advance of your procedure 1 877 767 7373 in the US Canada and Puerto Rico Outside the US Canada and Puerto Rico contact your local Animas distributor Page 11 Radiology X rays and Medical Procedure Quick Reference Chart Procedure Patient is Pumper Healthcare Professional Technician is Pumper E 5 a 2 Pump should remain covered by lead apron 2 Follow normal X ray practices and proceed to the 8 u placed on the patient by the dentist or designated safe area when each X ray is taken technician C fp PAN 1 No need to disconnect 1 No need to disconnect pump or site If site is directly in range of transducer site should be removed 2 Transducer should not be pointed directly at 2 Transducer should not be pointed directly at pump or site DO NOT expose pump to test 1 No need to disconnect 1 Disconnect pump prior to test and leave 2 Follow normal safety practices and proceed to the pump in locked dressing room designated safe area while each test is being performed DO NOT expose pump to X ray beam 1 No need to disconnect Mammogram and Bone Density Test 1 Disconnect pump prior to exam and leave 2 Follow normal X ray safety practices and proceed to the pump in locked dressing room designated safe areawheneach X ray is taken ray DO NOT expose pu
76. insulin dependent diabetes mellitus IDDM the beta cells are destroyed so the body can no longer produce insulin BG blood glucose levels Blood glucose levels are the measure of how much glucose sugar is in the blood The normal level is about 80 110 mg dL 4 5 6 0 mmol L bolus A bolus is the amount of insulin delivered at one time usually before a meal or when blood glucose is high cannula A cannula is a small tube that is inserted into the body Some infusion sets are designed so that only the cannula remains in the body and the needle used for insertion is removed dawn phenomenon More insulin may be required in the early morning hours of normal sleep to counteract the release of the hormones cortisol and adrenaline This increased need for insulin is known as dawn phenomenon and may cause a person with diabetes to have a high blood glucose level in the morning upon waking Basal rate delivery by the ANIMAS pump can be programmed to compensate for dawn phenomenon diabetes Diabetes is a complex disease in which the body cannot maintain healthy blood glucose levels because either enough insulin cannot be produced or the body cannot appropriately use insulin In Type 1 diabetes the body no longer produces insulin and in Type 2 diabetes the body cannot use insulin properly diabetic ketoacidosis DKA DKA results when there is not enough insulin available to help glucose enter the cells where it is used for energy Th
77. io scroll up to the desired field and press OK to activate Edit mode 4 Use the Up Down arrows to change settings As you change the Ratio by percentage the amount in units is automatically changed You cannot change the ratio by units only by percentage 5 When settings are correct press OK to confirm and exit Edit Mode Page 74 Note Your Animas 2020 is smart it will remember your last duration and the ratio as percentages you programmed So if you use the same duration and ratio for certain types of meals you need only change the total bolus amount the next time you use this feature However the last programmed Combo Bolus settings will be cleared each time you change the battery 2 27 pm ACTIVE BOLUS ACTIVE Normal Extend 30 70 Basal Rate 200 9 95 U 0 675U Hr Insulin 105U Status aa 6 Scroll to Go and press OK to activate The Home screen shows Combo Bolus active To cancel an active Combo Bolus from the Bolus Menu select Combo Details of the active Combo Bolus will be displayed Scroll to Cancel and press OK to cancel the Combo Bolus Note If you Suspend the pump any active Combo Bolus will also be canceled and the screen display will alert you Combo Bolus is also canceled when you change the battery and or prime Reminders This feature allows you to set personal reminders You can set two bolus reminders for times of day and one reminder to check BG at a certain time after a bolus
78. it is highlighted Press OK 3 Scroll up to highlight the field you wish to change or to next available blank line to add a segment Press OK to activate Edit mode The cursor will flash to indicate Edit mode 4 Use Up Down buttons to set Start times and U hr amounts Page 39 5 Check that the AM PM settings are correct gt If you program a segment to start at the same time as an existing segment the previously entered segment is deleted gt Ifyou program a segment to start at a time that precedes an existing segment the new segment is automatically inserted in the correct place You must then scroll to the new segment highlight the corresponding U hr field and enter or change amount if desired 6 When finished scroll to Save Review and press OK If you have edited the active program it is now resumed automatically The Basal Options screen is displayed a Select Review from the Basal Options screen to review your entries for accuracy Your basal segment settings are shown 5 on first screen 5 on second screen and 2 on last screen If you have more than 5 segments programmed scroll to Next to see second and third screens as desired b If you ve edited an inactive program select the program from the Basal Menu Press OK Select Go from the Basal Options screen to activate the program vou ve selected When you select Go the Home screen is displayed which shows the current rate of delivery for the program that is ac
79. ith the programming steps If you do not wish to use the Audio Bolus feature this button serves as a shortcut to the Normal Bolus screen See next section ezBolus gt When you first use the Audio Bolus feature you should always look at the screen to confirm correct programming until you are comfortable with the feature 1 Turn on Audio Bolus in the Setup Advanced menu and select your preferred step size See Chapter 11 Advanced Features 2 The Audio Bolus button is a soft rubber button on the end of the pump Press it once The pump will beep or vibrate to indicate you ve accessed Audio Bolus mode as well as indicate the step size you ve set up gt The number of beeps or vibrate pulses reminds you of the step size you ve set e 1 indicates 0 1 U step size e 2 indicates 0 5 U step size e 3 indicates 1 0 U step size e 4 indicates 5 0 U step size OUIS RAE Step size 1 0U Press 3 Press the audio bolus button once for each step size you ve Enter programmed to reach the desired total amount For example if you are bolus amount using 1 0 U step size and you wish to bolus 4 units press the button 0 00U 4 times You will hear a beep tone for each button press If you are f Press any other using 0 5 U step size and you wish to bolus 4 units press the button PaNRRWeyieil 8 times Page 63 4 Within 5 seconds the pump will respond with a number of confirmation beeps equal to the number of times you pressed t
80. ivity Setting 58 Setup Advanced 7 Personal Settings Insulin to Carb 1 C Ratios ce cecsseeeeeeees 58 Setup Advanced 7 Personal Settings Insulin Sensitivity Factor ISFE 59 Setup Advanced 7 Personal Settings BG Target Ranges senen enen vennen 60 Setup Advanced 8 Insulin on Board Setting ersonserrsensershensnnerse sers ietsnteanenerdabeadsensene 61 Setup Advanced 9 Sick Day Guidelines svv evene nenenonenenenenenenvnenen 62 Chapter 12 Using Advanced Features s scscssadamesonedovesoscasssaconenadeenensadeteeieswsesqcoumoseacsasces 63 Audie Bolus ANG e2BolS enne EEE EE EEE EOS 63 EBO o e E E E E E E E E EE E E E E EE seks 65 Advanced Bolus Rd Wes neer mdtenestensmemedkenthesnnehe EENE ENES 65 An 65 Entering Carbs Manually no food database ssesessesesossesossesossesossesossesosessosesso 66 Adding BG Bolus 1007 Cal D ccacs cic scucueavaessetasensonsumiwewnssicaecnedcenwius pene pieauceehennoueeeesedus 67 Entering Carbs Using the Food Database ccccccecesecescscscececececscecececececeeeseees 68 Editing Szerb Tota EWG 6S scccscu ro scsccvrnccssocsnensoncnosmumecscetouan TOENE eE TAIEREA Er 71 An 72 Combo Bolus sessesessseessossessoosseseosseseoosssssoosesesosssecoossesccoseeesossessocsseecoosseescssseeooo 74 BPG e E sosetacauss te ascuancsssebanusassneeenas A EE 75 Bolus RENU CTs a E A AE ETE E AEA E E T EEEE 75 BG CHECK KEMIT OC orerar or e n E E E AT E
81. ll deliveries stop CARTRIDGE Continuous until confirmed NO DELIVERY Press OK to confirm Replace with full cartridge Action Replace Option to select Suspend see Suspend caidos User selected every 3 minutes If not confirmed Beeps Vib progresses to sweep vibe within one hour Once Se confirmed No Prime warning triggered see No Prime Alarm Replace Battery REPLACE ane either has minimum 3 minutes left or battery BATEN Effect All deliveries stop NO DELIVERY Continuous until battery is removed Remove battery Remove battery to silence alarm Insert new battery TE Beeps Vib MAX volume every 3 minutes until action taken DEE Alarm Call Service Hardware or software problem detected ALARM Effect All deliveries stop mank Continuous until battery is removed NO DELIVERY Press OK to silence alarm for 30 minutes alarm can only 064 0108 Action be silenced once Call Pump Support Outside the US amp ae Remove batt Canada contact your local Animas distributor nd User selected every 3 minutes If not confirmed the alarm Beeps Vib i op progresses to sweep vibe within one hour Alarm Auto Off J ALARM on due to no key press in user set time NOFF Effect All deliveries stop NO DELIVERY Continuous until confirmed No button Press OK to confirm Adjust time period in Setup presses in last Action Advanced 12 hours Confirm Beeps Vib MAX volume every 3 minutes until action taken Once P con
82. locked dressing room Follow usual instructions for bolusing to cover any missed basal insulin when you reconnect g E 4 2 53 0 4 A Lj Page 12 gt Amusement Parks Very powerful electromagnets are sometimes used on free fall amusement park rides Insulin pumps should be removed and not taken on these free fall types of rides High gravity forces can be experienced when riding on some roller coasters It is recommended that you disconnect NOT suspend the pump while on roller coaster rides Aircraft without Cabin Pressurization If flying in aircraft without cabin pressurization or flying in aircraft used for aerobatics or combat simulation pressurized or not it is recommended that you disconnect NOT suspend the pump Precautions gt The Animas pump is a sealed device that should be opened ONLY by the manufacturer If the pump seal is broken by anyone other than an authorized Animas factory technician the warranty is voided and the pump is no longer waterproof If the back label on the pump is removed or damaged the warranty is voided and the pump is no longer waterproof When using an insulin pump if the pump is placed at a vertically higher position than the infusion site a very small amount of additional insulin infusion may occur To minimize this condition and maintain pump delivery accuracy the vertical distance between the pump and the infusion site should be no more than 12 inches 3
83. m is displayed Safety Information gt The Animas 2020 is designed only for Continuous Subcutaneous Insulin Infusion CSII It is not intended for use with any other delivery substance gt This User Guide gives instruction on how to program and operate the pump Animas Corporation does not make any recommendations on specific programming related to your diabetes care program Consult your healthcare team for instructions specific to your treatment plan gt Consult your healthcare team before using the pump to determine which programming features are appropriate for you Some features require a greater knowledge of insulin pumping and advanced self care skills Additionally some advanced programming features require that testing and fine tuning of basic settings be completed in order to achieve the best possible results Your healthcare team will give you specific training on programming and using your pump Page 14 gt Use of Extended Bolus Combo Bolus ezCarb carb calculator Insulin on Board and ezBG blood glucose correction calculator all require input from your healthcare team Do not attempt to use these features until you have specific information for your treatment plan and have had specific training on each programming feature gt Only your healthcare team can determine your insulin to carbohydrate ratios correction factors blood glucose target ranges and duration of insulin on board gt Basal rates that ar
84. millimoles liter To convert mmol L to mg dL multiply by 18 or divide by 0 055 occlusion Occlusion means blockage The ANIMAS pump is designed to be able to sense when delivery of the insulin is being blocked for some reason The pump will automatically stop delivering insulin and give an alarm to alert you to clear the occlusion and restart the pump OLED display organic light emitting diode This is the kind of display screen used on the Animas pump The OLED display uses color and provides enhanced contrast o ring Both the cartridge and the battery cap contain an o shaped ring made of a soft material that functions as a seal when compressed O rings operate properly only if the surface is free of defects cuts scratches abrasion pancreas The pancreas is a glandular organ just behind the stomach next to the liver It produces digestive enzymes used to break down proteins in food It contains alpha cells which produce glucagon and beta cells which produce insulin stress hormones Stress hormones or counter regulatory hormones are released by the body in times of intense physical or emotional stress These hormones cause the body to release glucose If the glucose is not used as energy hyperglycemia and ketoacidosis can result subcutaneous Subcutaneous means beneath the skin The infusion set needle is placed subcutaneously Page 107 Type 1 diabetes Type 1 diabetes results from destructi
85. mp to radiation treatment 1 No need to disconnect 1 Disconnect pump prior to radiation 2 Follow normal radio protection practices and proceed to the treatment and leave pump in locked dressing designated safe area while the patient is undergoing treatment Fluoroscopy chest neck abdomen torso 2 Ifthe infusion set doesn t interfere with the area being treated the set can remain in place during radiation DO NOT bring the pump into the exam room MRI DO NOT bring the pump into the same room as the MRI at any time machine at any time 1 Disconnect pump amp metal needle If the pump is accidentally allowed in the MRI room disconnect infusion set prior to exam and leave in the pump immediately and contact Animas Pump Support for locked dressing room instructions 2 Soft cannula infusion sets can remain in CT SCAN No need to disconnect place 3 If the pump is accidentally allowed in the Follow normal CT Scan safety practices and proceed to the exam room disconnect the pump immediately designated safe area when each Scan is performed and contact Animas Pump Support for Radiation Oncology cancer treatment by radiation Imaging Disconnect from pump during surgery No need to disconnect 1 Disconnect prior to surgery and leave in 2 Ifthe infusion set doesn t interfere with the area being treated the set can remain in place during surgery When in doubt disconnect and leave pump in
86. mus jnj com Outside the United States Canada and Puerto Rico call 610 644 8990 or contact your local Animas distributor We understand that you may have questions and concerns when using a new product Please do not hesitate to call for assistance Supply Reordering You can place orders for cartridges infusion sets skin prep batteries and many pump accessories by calling our Reorder Department or by visiting our eStore at https estore animascorp com In the United States Canada and Puerto Rico call 1 877 YES PUMP 877 937 7867 Outside the United States Canada and Puerto Rico contact your local Animas distributor Important Note e Do Not Remove the New Factory Installed Plastic Display Lens Protection Film Your pump now comes with a new factory installed transparent plastic lens protection film covering the display lens This protective film is highly durable and is designed to protect your pump display lens from incidental damage Please do not attempt to remove this film This protective film must remain in place at all times to fully protect your pump display lens from scratches and other cosmetic damage This film will not protect your pump display lens from extreme abuse Should the pre installed lens protection film become damaged or separate from the display the film should be replaced Replacement films are available through the following sources In the United States and Puerto Rico call Animas at 1 877 YES PUMP
87. n Basal Menu ae MER UUS Note If a program other than 1 Weekday is active you cannot change this setting to display 1 basal program The Alert screen shown here ws will pop up to remind you must be the 1 Scroll to the desired field een to change the 2 Press OK to change to flashing cursor for Edit mode basal display setting 3 Use the Up Down buttons to change to desired setting Confirm 4 Press OK when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK Setup Advanced 3 Insulin Limits This screen allows you to e Set maximum basal delivery per hour SETUP ADV e Set maximum bolus amount LIMITS e Set maximum daily 24 hour delivery amount Scroll to the desired field Press OK to change to flashing cursor for Edit mode Use the Up Down arrows to change to desired setting KR OW N e Press OK when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK gt Should you attempt a delivery that exceeds the limits you have set the pump will alert you and display a text message See Chapter 14 Safety System and Alarms for additional information Page 56 Setup Advanced 4 Language Setup Display Timeout Contrast and Battery Type This scree
88. n allows you to e Select a different language e Set the length of time your display stays on before timing out to save battery life o 15 30 45 or 60 seconds e Select a contrast setting e Select Lithium recommended or Alkaline battery type nn Scroll to the desired field Display timeout in 60 Press OK to change to flashing cursor for Edit mode shan HA WW PO Use the Up Down arrows to change to desired setting 4 Press OK when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK Contrast Button Pressing the button on the top of your pump adjusts the contrast There are three contrast levels Dim Default and Bright To preserve battery life your pump display will Auto dim when a button is not pressed for half the time your display time out is set While in Auto dim mode you can restore the default contrast level you have set by pressing the Contrast button on top of the pump Pressing a function button while in Auto dim mode will restore the default contrast level as well as perform the function of the key If in Call Service Alarm mode you must use the Contrast button to restore the default contrast level To return contrast setting to original factory default press the Up Arrow and Contrast button at the same time When the word Contrast is displayed on the screen press any butto
89. n pump and its packaging On the front of the pump Up Arrow button Down Arrow button JK OK button On the top of the pump Contrast button On the back of the pump AN Important Information See User Guide for Instructions for Use S N Serial Number Date of Manufacture IPX8 Water Tight Equipment protected against the effects of submersion tested to 12 feet 3 6 meters for 24 hours e Type BF Medical Equipment patient isolated not defibrillator protected CE Mark conforms to the directives of the European Community Rx Only Caution Federal US law restricts this device to sale by or on the order of a physician ye Hazardous waste Residents of US Canada and Puerto Rico dispose of in accordance with federal state and local regulations All other customers contact your local Animas distributor for disposal Page 19 Page 20 Chapter 4 Introduction to Your Animas 2020 Pump An insulin pump is a tool to allow you to better manage your diabetes by mimicking the way a healthy pancreas delivers insulin When connected to a properly inserted infusion set your pump delivers insulin at a continuous low level basal rate 24 hours a day You program delivery of a higher level dose bolus of insulin to cover food eaten or to correct high blood glucose BG Animas pumps are engineered and manufactured to the highest standards of quality Although it is a highly sophisticated medical device i
90. n to return to the default contrast setting Note When viewing the pump display in bright sunlight it is recommended you shade the screen or move to a shady area for best visibility Setup Advanced 5 Auto OFF Feature This screen allows you to set the pump to automatically suspend basal delivery and sound an alarm if no buttons are pressed in a user selected number of hours This feature can be used as a safeguard in case the user is unconscious SETUP ADV 5 1 Scroll to the desired field AUTO OFF 2 Press OK to change to flashing cursor for Edit mode Enana OFF When enabled 3 Use the Up Down arrows to change to desired setting suspendin 12 Hr if no buttons 4 Press OK when setting is made are pressed To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK Page 57 Setup Advanced 6 Low Cartridge Warning Setting and Occlusion Sensitivity Setting This screen allows you to e Set your low cartridge warning to alert you at 10 20 30 40 or 50 units remaining e Set your occlusion detection sensitivity to High more sensitive or Low less sensitive SETUP ADV 6 1 Use the Up Down arrows to scroll to the desired field 2 Press OK to change to flashing cursor for Edit mode eae 3 Use the Up Down arrows to change to desired setting 4 Press OK when setting is made gen To move to the next Setup Adv
91. o prevent accidental button pressing Simply wake up the pump and press and hold the Up and Down arrow buttons at the same time until the screen reads Locked This locks the pump keys To unlock the pump wake up the pump so the screen reads Locked and press and hold the up and down buttons at the same time until the screen display wakes up Basic Display Screens Verify Screen When you insert a battery this is the first screen you see after the Animas logo screen From here you can verify the settings for time date language and battery type Home Screen Once you have your pump set up the Home screen is the first screen that is displayed when you wake up your pump Press any button to wake up your pump The Home screen shows the time of day a battery life indicator if you have an extended bolus or temp basal currently active current basal rate amount and how much insulin remains in your cartridge You access the Main Menu from here or you can take a Sele shortcut to the Status menu After a set amount of time with no button finsulin 405U presses the pump display screen will time out to conserve battery life Basal Rate Page 23 When the pump times out the screen display is blank The battery life indicator is shaded to show approximate battery life remaining Main Menu Screen This screen shows all Main Menu options Bolus This selection takes you to the Normal Bolus screen If you have a
92. ology becomes more sophisticated it is possible that an insulin pump will set off the detector For more information on traveling with insulin pumps visit the American Diabetes Association ADA website www diabetes org or call your local airport for security guidelines that may apply Intimacy The Animas pump need not interfere with intimacy You can disconnect most infusion sets Always follow your healthcare team s guidelines when disconnecting from your pump You may need to compensate for missed basal insulin Also before and after you disconnect for any length of time remember to check your blood glucose levels Page 96 Chapter 18 My Information This chapter provides tables to record information needed for programming your personal settings into the pump Consult your healthcare team for correct information for your personal treatment plan Insulin to Carb Ratios I C Daily Time Slot My I C ratio em Insulin Sensitivity Factor ISF Time of Day My ISF wan Temp Basal Rate Decrease for Activity Set Temp in Minutes Activity Type Decrease advance of activity to set in yes or no advance Light gardening walking shopping Moderate leisurely biking golf no cart Strenuous basketball jogging swimming Sustained ice skating rowing hiking o ooo o My duration for Insulin on Board is Basal Programming Program 1 Program 2 Program 3 Program 4 SEGMENT Weekday Other Week
93. omagnetic fields such as in MRI s RF welders or magnets used to lift automobiles If you plan to undergo an MRI remove your pump beforehand and keep it outside the room during the procedure Page 10 gt Medical Procedures Procedure Patient is Pumper Healthcare Professional Technician is Pumper Pacemaker AICD Disconnect pump and leave outside room during Follow normal safety practices and insertion of device and reprogramming Infusion proceed to the designated safe set can remain in place area while each X ray is taken and during reprogramming EKG _i No need to disconnect No need to disconnect Cardiac Catheter Disconnect pump and leave outside room Follow normal safety practices and during procedure proceed to the designated safe area while each X ray is taken Nuclear Stress test Disconnect pump and leave outside room during Follow normal safety practices and scan Can remain connected during injection proceed to the designated safe area of radioisotope while each X ray is taken Colonoscopy No need to disconnect No need to disconnect Laser Surgery The pump and infusion set can be worn The pump and infusion set can however some lasers can create interference and be worn however some lasers can cause the pump to alarm create interference and cause the pump to alarm General anesthesia Determination based on what medical Determination based on what equipment is being used in the procedure med
94. on of the beta cells in the pancreas People with Type 1 diabetes must use insulin to regulate their blood glucose levels Type 2 diabetes Type 2 diabetes develops as a result of insulin resistance and usually occurs in people 40 years old or older People with Type 2 diabetes can usually regulate their blood glucose levels by following an individual meal plan exercising and taking certain medicines including insulin if needed Page 108 Technical Specifications for the Animas 2020 Note When applicable testing used 23 Comfort infusion set and temperature of 23 C 1 C Number of Basal Segments 12 per Program Number of Basal Programs 4 Basal Delivery Frequency minimum every 3 minutes Temp Basal Range 90 to 200 in 10 increments OFF Temp Basal Duration 0 5 hrs to 24 hrs Extended Bolus Duration 0 5 hrs to 12 hrs 0 1 hr Battery Type 1 5 Volt Energizer AA L91 Lithium or 1 5 Volt AA Alkaline Number of Batteries 1 Battery Life Typical use approximately 5 to 7 weeks for a lithium battery and approximately 2 to 3 weeks for an alkaline battery Maximum volume infused under single fault condition Max 2 0 U Cartridge Capacity up to 2 0 mL or 200 units Continuous Operation Internally Powered Device Type BF Medical Equipment Patient isolated not defibrillator protected Watertight Equipment IPX8 protected against the effects of submersion tested at 12 feet 3 6 meters for 24 hours Storage Condition
95. or information on ezManager software and the IR Accessory Kit For instructions on uploading basal program information refer to the ezManager User Guide included with the software Setting a Basal Program Each basal program can be set with up to 12 different basal rates doses in a 24 hour period These 12 start times can be set to accommodate your changing basal needs throughout the day For example your body may need more insulin in the early morning to compensate for the dawn phenomenon You can program time segments to begin at any hour or half hour Note The Up Down buttons will move the cursor through fields when not in Edit mode When in Edit mode the Up Down buttons will change the value of the field If the cursor is flashing that means you can edit the entry Use the OK button to start stop Edit mode Use the chart in Chapter 18 My Information to record and enter your basal program times and doses as recommended by your healthcare team 1 From the Main Menu select Basal 2 The Basal Menu displays the following e Total basal insulin programmed for the 24 hour period e Temp if you wish to program a Temporary Basal rate e The active basal program designated by number and by name as well as an A to indicate the active program If you have activated multiple basal programs in Setup Advanced all 4 basal program options will be displayed as shown below right 3 Scroll to select the program A1 WEEKDAY
96. ows you to enter your BG reading and your Animas 2020 will calculate a correction bolus based on the Insulin Sensitivity Factor and BG Target Range for the current time of day If the Insulin on Board IOB feature is activated your Animas 2020 will calculate a reduced dose for high BG correction boluses that you can review 1 From the Bolus Menu select ezBG Press the OK button 2 The Actual field will be highlighted and flashing to indicate Edit mode Use the Up Down arrows to enter your actual BG reading Press the OK button to confirm the entry and exit Edit mode 3 Check to be sure the Target BG amount and Insulin Sensitivity Factor ISF are correct Your healthcare team will give you these values If you need to edit these fields scroll up to highlight the field and press OK to activate Edit mode Use Up Down arrows to change target Press OK to confirm and to exit Edit mode 4 Show Result is highlighted Press OK Show Result Page 72 5 The ezBG Total screen is displayed with a suggested bolus amount The bolus amount field is highlighted and flashing to indicate you can enter the total amount as shown or adjust as needed Enter your bolus amount Press OK to deliver ezBG Total ezBG Total DELIVERING Press any function button o Cams Note If Insulin on Board IOB feature is activated your Animas 2020 will calculate a reduced BG Bolus amount for your review ezBG Total Note If you enter a BG
97. pump stores these records indefinitely even when batteries are removed The pump stores basal rates boluses alarms and settings From the Main Menu select History The History Menu is displayed Bolus History Your Animas 2020 displays the last 500 Bolus records Note BG values and carb values are not displayed on your Animas 2020 however when you download your pump history with ezManager the BG and carb values 500 total will be displayed on the ezManager reports 1 From the History Menu select Bolus This screen displays the following e Bolus Record number Date of bolus Time of bolus Type of bolus delivered o Normal o Combo If Carb Active Canceled o BG o Carb o Audio Amount of bolus How much of programmed amount was delivered Mar 23 2003 2 Scroll up to highlight the record field Press OK to activate N ua Review Mode indicated by flashing cursor Rotan sot 3 Record 1 indicates the most recent record Use the Up Down arrows to scroll to other records History Menu 4 When finished reviewing press OK to exit Review Mode 5 History Menu is highlighted Press OK to return to History Menu Page 47 Total Daily Dose TDD History Your Animas 2020 displays the last 120 TDD records 1 From the History Menu select TDD This screen displays the following Record number HISTORY Date of record If Temp Basal was active on that date Total Daily Dose TDD If Suspend was activated on
98. r healthcare team For more information on sick day guidelines refer to Chapter 16 Sick Day Guidelines and contact your healthcare team This screen allows you to e Seta BG limit as a reminder for testing when sick e Set the frequency of checking for ketones when sick e Set the frequency of checking your BG when sick SETUP ADV Sick Days To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK To return to the Home screen scroll to Home and press OK Note This screen is intended as a reference only Alerts are NOT triggered based on values displayed on this screen Page 62 Chapter 12 Using Advanced Features gt Using the features in this chapter requires an advanced understanding of insulin pump therapy and should not be used without training and advice from your healthcare team In order to achieve optimal results some of these features should only be used once you have tested and fine tuned your basal rates and your healthcare team has determined your individual targets and ratios Note Before using these features you must turn them on in the Setup Advanced Menu See Chapter 11 Audio Bolus and ezBolus The Audio Bolus feature of the Animas 2020 allows you to bolus without looking at the screen display This is convenient if you wear your pump under your clothing When first using the audio bolus feature also check the display screen until you are comfortable w
99. r more information on Combo Bolus see Chapter 11 Advanced Features The cursor is flashing on the Status Screen number 4 Press the Up arrow to move to Status Screen 5 or press OK to highlight Main Menu and exit Status screens Status Screen 5 Temp Basal The screen displays the following information STATUS 5 e Most recent Temp Basal status TEMP SSA o Active ACTIVE o Inactive o Start time o End time o adjustment The cursor is flashing on the Status Screen number 5 Press the Up arrow to move to Status Screen 6 or press OK to highlight Main Menu and exit Status screens Page 52 Status Screen 6 Codes The screen displays the following information Software revision REV 06 27 03 Serial number of pump S N 87654321 _01_23 45 67 Code for manufacturer s use Code for manufacturer s use Code for manufacturer s use Code for manufacturers use X9A 00 O9 OC The cursor is flashing on the Status Screen number 6 Press OK to highlight Main Menu and exit Status screens Page 53 Page 54 Chapter 11 Advanced Features Setup and Activation Now youve made it through the basics Your Animas 2020 offers many advanced features that you may find helpful in managing your diabetes Consult with your healthcare team to determine which advanced features are appropriate for you This chapter tells you how to set up and turn on the advanced features Chapter 12 covers how to use each advanced feature You c
100. r to ten hours Page 88 Several things can cause a high BG reading The most common problems and causes of high blood glucose are listed in the following table as are some suggested solutions Possible Cause of High BG Suggested Solution Redness irritation inflammation Change infusion set tubing and site Contact healthcare team swelling discharge or discomfort Bump or nodule at infusion site Change infusion set and rotate sites Avoid this area for site selection Scar tissue Avoid this area for site selection Catheter inserted in area of Avoid waistline and friction areas friction Kink in tubing catheter Change infusion set tubing and site Infusion set not primed air in Disconnect tubing from body Prime tubing completely tubing INSULIN Cloudy clumpy expired or insulin Remove infusion set and cartridge and discard tcc dan Using Regular insulin Consult healthcare team May need to use alternate insulin as prescribed by your physician FOOD INTAKE el Bolus insufficient or omitted Review carbohydrate counting and I C ratio settings High protein or fat intake Consult dietitian may need to count protein and fat Long meal holiday continuous Consult healthcare team May need to use extended bolus or snacking slowly absorbed food combination bolus option high fiber delayed digestion gastroparesis AMY Overuse of Temp Basal reduction BG gt 250 with ketones before exercise Do not exerci
101. replaced approximately every 2 3 days or as directed by your healthcare team Refer to the insulin labeling and follow the direction of your healthcare team for frequency of replacing the cartridge gt Occasionally check the infusion set tubing for any damage air bubbles leaks or kinking which may restrict or stop insulin delivery and result in under infusion Page 34 Chapter 6 Using the Normal Bolus Feature Your Animas 2020 offers several advanced bolus options which can be activated from the Setup Advanced Menu The bolus feature allows you to program an insulin delivery to cover food eaten or high blood glucose You and your healthcare team can determine which features are best for you See Chapter 11 Advanced Features This chapter covers the basics of a Normal bolus which is used to cover food you ve eaten and to correct high blood glucose MAIN MENU NORMAL BOLUS NORMAL BOLUS 0 000 ZN Press any function button to Cancel 2 The cursor will flash over the amount field to indicate that it can be edited Use the Up Down arrows to enter desired bolus amount Press OK 3 Go is highlighted Press OK to deliver the bolus 4 The Delivering Bolus screen is displayed If you have activated the Normal Bolus sound in the Setup Sound Menu the pump will beep to confirm start of delivery as well as when delivery is complete Bolus A delivery gt During a bolus delivery you can stop delivery at any time eancciad
102. rget BG ranges See Chapter 11 Advanced Features If the Insulin on Board IOB feature is activated your pump will calculate a reduced amount for high BG correction boluses ezCarb food database available through upload from ezManager For instructions on uploading food database refer to ezManager User Guide included with the software Page 65 Entering Carbs Manually no food database 1 From the Bolus Menu scroll to ezCarb Press OK The ezCarb Home screen is displayed 2 The cursor will flash on the Carbs field to indicate that you can edit the total number of carbs eaten Use the Up Down arrows to enter the number of carbs Press OK Add BG is highlighted See next section Adding a BG Bolus to ezCarb Note The max limit for ezCarb Total is 999g If your meal total is more than 999g the pump display will show the actual total However the ezCarb Home screen will use the max number for the calculator BOLUS MENU Carbs Actual Actual lC 1U Food List Review Total Show Result 3 Check that the grams of carb entered and your insulin to carb I C ratio at the top of the screen are correct a If the entries are correct scroll to Show Result Press OK and go to Step 5 b If not correct scroll up to highlight the field and press OK to activate Edit Mode Use Up Down arrows to enter your I C ratio and or change the carb entry Press OK 4 Scroll down to Show Result Press OK 5 The Bolus Total scr
103. s 4 F 20 C to 140 F 60 C 10 to 100 relative humidity including condensing 50 kPa to 106 kPa Batteries must be removed during storage periods exceeding 2 weeks Operating Conditions 40 F 5 C to 104 F 40 C gt Outside these temperatures the flow accuracy and time to occlusion could be compromised 20 to 90 relative humidity including condensing Ambient pressure 70 kPa to 106 kPa Page 109 Pump Disposal Contact Animas Corporation for pump disposal information Outside the US Canada and Puerto Rico contact your local Animas distributor Infrared communication port Audio Bolus Range e 0 1 2 0 Uin 0 1 U step e 0 5 10 0 Uin 0 5 U step e 1 0 20 0 U in 1 0 U step e 5 0 35 0 U in 5 0 U step Flow Rate Accuracy Delivery Mode Bolus 0 100 U hr Basal and higher Accuracy rate will be lower at basal rates less than 0 100 U hr Occlusion Detection time to alarm pf Typical Bolus 3 units or more 0 025 U hr basal 1 0 U hr basal Certain factors such as the presence of air in the infusion set or the cartridge and or ambient temperature changes can delay an occlusion alarm Occlusion Pressure Threshold 75 kPa typical 241 kPa max Bolus Volume after Occlusion release 1 0U hr basal e 1 0 U max with occlusion sensitivity set to high e 3 0 U max with occlusion sensitivity set to low Delivery Rates e Bolus under 1 U 1 1 to 2 2 U sec e Bolus 1 U or more normal delivery sp
104. s During low contact sport activities such as walking biking or aerobics the pump can be clipped to the waistband or for added security placed in a sport case During contact sports such as baseball basketball or hockey the pump can be disconnected for up to one hour Always follow your healthcare team s individual guidelines when disconnecting your pump because you may need to compensate for missed basal insulin Before and after you disconnect for any length of time remember to check your blood glucose levels Swimming Your Animas 2020 is tested for immersion in water to a depth of 12 feet for 24 hours under normal swimming conditions You should not wear your pump while scuba diving or when using high diving boards Your pump should not be taken into hot tubs as the extreme temperature can adversely affect insulin quality If your pump has been dropped examine it carefully for cracks or signs of damage If the back label of the pump is not securely affixed or if you suspect your pump may have been damaged or otherwise had its waterproof integrity compromised do not use in water Call our 24 7 Pump Support Department at 1 877 767 7373 Outside the US amp Canada call your local Animas distributor Traveling With an insulin pump traveling becomes less complicated and more enjoyable However traveling still requires preparation Remember to order your pump supplies in advance and pack the following items
105. s Press the OK button to confirm your setting and exit Edit mode 5 Use the Up Down arrows to select the next field Repeat the above process Scroll to highlight Main Menu and press OK button when finished The Main Menu screen will be displayed gt Ifyou select the 12 hour time format the AM PM indicators will change as you scroll to set the time Be sure the desired AM or PM selection is correctly displayed when setting the time gt If you select the 24 hour time format the time will be shown in military time Daylight Saving Time certain states and countries only Spring Forward If you advance the hour on your pump clock after 11pm but before midnight you must also manually forward the date by one day If you change your pump clock after midnight your pump date will have changed automatically to the appropriate date Fall Back It is recommended that you set your clock back before midnight on Saturday or after 1am on Sunday This keeps your pump set to the correct date Your pump will register an additional hour in the Daily Totals History because the day has essentially been altered to consist of 25 hours If you change the clock between midnight and 1am you must also change the date This will result in a duplicate date entry in your history This duplicate entry will contain up to one hours worth of insulin delivered Sounds Setting Changing Note that this menu only adjusts sounds It does not activ
106. s a continuous 24 hour basal rate and bolus insulin deliveries to accommodate for immediate doses to cover foods eaten and high blood glucose It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self care Your pump is covered by a limited warranty for 4 years Some circumstances that void the warranty are e Ifthe pump is taken apart by anyone other than an authorized Animas factory technician e Use of any battery other than those specified in Chapter 5 of this User Guide Please take a moment to look at the back of your pump and write down the serial number My pump serial number is snee IR 2020 INSULIN PUMP 24 7 PUMP SUPPORT Te 1 877 767 7373 SUPPLY ORDER 1 877 YES PUMP Serial Number S N anal 2006 12 S N 49 00015 XX MONDEO DOOU INIO OONT MONIT T S y v z EN F N N Ww 5 D lt gt gt AINOXH BX ak S 5 s 5 For more details on your pump warranty see p 111 or the warranty section of this User Guide Page 7 Technical and Clinical Help If there is anything you don t understand in the User Guide or if you have a question or need assistance with your pump our Pump Support Department is available to you 24 7 In the United States Canada and Puerto Rico call 1 877 767 7373 for assistance every minute of every day For non urgent technical questions please email customersupport an
107. s Vib User selected every 3 minutes until confirmed If not P confirmed progresses to sweep vibe within one hour Warning Delivery Canceled due to Low Cartridge Banse Basal or Bolus delivery exceeds insulin remaining in cartridge Deli Effect Basal or Bolus delivery stopped haat Once per occurrence and each time awakened until due to Message iow confirmed cartridge Action Press OK to confirm Replace with full cartridge Beeps Vib User selected every 3 minutes until confirmed If not P confirmed progresses to sweep vibe within one hour Warning No Prime No Delivery J Cause Pump is not primed Er Pump is Effect All deliveries stop not Primed Message Every 3 minutes or when awakened manually No Delivery Action Press OK to confirm Disconnect reprime Beeps Vib User selected every 3 minutes until confirmed If not P confirmed progresses to sweep vibe within one hour Alarm Occlusion J Cause Occlusion detected r OCCLUSION Effect All deliveries stop DETECTED Message Continuous until confirmed NO DELIVERY Action Press OK to confirm Disconnect and prime to clear occlusion Option to select Suspend see Suspend User selected every 3 minutes If not confirmed Suspend Beeps Vib progresses to sweep vibe within one hour Once Confirm confirmed No Prime warning triggered see No Prime Page 85 Alerts Warnings and Alarms Alarm Empty Cartridge J Cartridge empty EE EMPTY Effect A
108. se the vibrate feature during sleep It is recommended that you set the volume to high for all warnings and alarms before going to sleep gt Always remove all air bubbles from cartridge and tubing before beginning insulin delivery Air bubbles can compromise accuracy of delivery Refer to the Instructions for Use included with your cartridge packaging Page 15 Interference with the pump electronics by cell phones can occur if worn in close proximity It is recommended that you wear the pump and cell phone at least 6 inches apart gt If you return your pump for service and a replacement pump is sent do not use the replacement pump until all the settings specific to your treatment plan have been programmed If you drop the pump or it has been hit against something hard inspect it to be sure it is still working properly Check that the display screen is working and clear that the cartridge cap battery cap and infusion set are properly in place Check for leaks around the cartridge by wrapping a piece of tissue around the connection area Cracks chips or damage to the pump may impact the battery contact and or the waterproof feature of your pump Call our 24 7 Pump Support Department at 877 767 7373 if you identify or suspect your pump has been damaged They will help determine if your pump should be replaced Outside the US Canada and Puerto Rico contact your local Animas distributor The pump is designed to operate in conditions wh
109. se when ketones are present Consult healthcare team for exercise guidelines gt Infusion set should be changed every 2 to 3 days or as recommended by your healthcare team gt Always use clean technique gt Notify healthcare team with signs or symptoms of infection Page 89 SMBG Self monitoring of BG Insufficient BG testing Check more often when BG is elevated Rebound high BG after low BG Check 3 am BG May need to adjust basal rate during night Somogyi Effect Consult healthcare team Elevated fasting BG May need to adjust basal rate Consult healthcare team Insulin sensitivity factor not Consult healthcare team for possible recalculation of sensitivity correct or not used factor Medications steroids Inform physician of all medication changes or additions terbutaline other hormone treatments Infection illness virus Refer to Sick Day Management Guidelines Pre menstrual cycle Consult healthcare team May need to use Temp Basal or set additional Basal Program Pregnancy Insulin requirements may increase in later trimesters Consult healthcare team Weight changes May need recalculation of basal or bolus doses Consult healthcare team gt Consult your healthcare team before making any changes in your basal rates bolus ratios or correction factor gt When in doubt change it out 1 Follow guidelines provided by your healthcare team 2 Change infusion set 3 Check for ketones 4
110. st return your original pump to Animas In the event it is not returned this warranty shall be void and the user will not be entitled to future pump replacement or repairs This limited warranty is valid only if the Animas insulin pump is used under normal use and conditions and in accordance with the manufacturer s instructions as detailed in the Owner s Book provided to you at time of purchase This limited warranty does not extend to any damage resulting from the following e changes or modifications to the pump by the user or any other third person after the date of manufacture e service or repairs performed by any person or entity other than an Animas authorized service person e a force majeure or other event beyond the control of Animas e accidents negligence misuse or abuse of the pump by the user or any other third person including but not limited to improper storage of or physical abuse such as dropping or otherwise damaging the Animas insulin pump or e normal wear and tear including but not limited to cosmetic damage such as scratched display lenses and or scratched paint This limited warranty only covers the pump and does not cover batteries infusion sets cartridges battery caps or other accessories of the insulin pump Except as expressly set forth in this limited warranty all other warranties are expressly disclaimed and excluded including without limitation any warranties of merchantability or fi
111. sulin on Board Duration 4 0 Hr Press OK to change to flashing cursor for Edit mode Use the Up Down arrows to change to desired setting KR OW PO e Press OK when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight Next Press OK Page 61 To return to the Home screen scroll to Home and press OK Note The pump is constantly tracking insulin on board so when you turn on the feature the pump will immediately take into account the current amount remaining from previous bolus doses within the time frame you ve selected during set up of the feature Recommended reading for insulin pump users includes e Pumping Insulin by John Walsh PA CDE and Ruth Roberts MA e Smart Pumping by Howard Wolpert MD Points to remember about Animas IOB feature on the Animas 2020 e A curvilinear algorithm is used which more closely mimics the way drugs decay in the body versus a straight line decay e With BG below target IOB amount is displayed and is subtracted from carb bolus e With BG within target IOB amount is displayed for reference but not subtracted from bolus total e With BG above target IOB amount is displayed and is subtracted from BG bolus Setup Advanced 9 Sick Day Guidelines During your pump training your diabetes educator will discuss guidelines to use when youre sick This is a convenient way to store your basic sick day guidelines as recommended by you
112. sulin to process food Symptoms of hyperglycemia include nausea vomiting muscle and joint aches blurred vision excessive thirst and frequent urination Over time weight loss can result Hyperglycemia can occur even while using an insulin pump and can lead to diabetic ketoacidosis DKA if untreated hypoglycemia Hypoglycemia is also known as low blood glucose It occurs when blood glucose levels drop to below 70 mg dL 4 0 mmol L This can happen if a person with diabetes has taken too much insulin or has exercised more than usual Symptoms of hypoglycemia include dizziness shakiness rapid heartbeat sudden hunger cold or clammy skin fuzzy vision confusion mood changes and tingling or numbness in the hands arms tongue or lips Hypoglycemia can occur even while using an insulin pump and if left untreated can lead to unconsciousness and diabetic coma infrared Infrared is a wireless means by which the pump communicates with external devices using an optical signal which is invisible to the human eye infusion set An infusion set consists of a length of thin plastic tubing available in various lengths with a Luer lock connector at one end and at the other end a very small cannula that is placed under the skin It is connected to the insulin pump and used to deliver insulin to the body infusion site The infusion site is the place on the body where the infusion set needle is inserted under the skin insulin Insulin is a
113. t has been carefully designed to be easy to use Get to Know Your Animas 2020 Contrast button Up button Down button Audio Bolus ezBolus Display button Screen OK button Main Programming Buttons There are 3 buttons for main programming functions The Up and Down buttons allow you to move through screen selections and to scroll up and down to enter values such as a bolus amount The OK button allows you to select an item or activate a function Programming Basics e Your Animas pump is menu driven much like an ATM machine e Use the Up Down buttons to scroll to the desired selection and then press the OK button to select If the cursor is flashing it means the pump is in Edit Mode and by scrolling with the Up Down buttons you can edit the flashing field e Once you ve finished editing press the OK button to confirm your entry and to exit the Edit Mode Display Screen All programming operations warnings and alarms are shown on the display screen Page 21 Contrast Button Pressing this button adjusts the contrast of your display There are three contrast levels Dim Default and Bright To preserve battery life your pump display will Auto dim when a button is not pressed for half the time your display time out is set While in Auto dim mode you can restore the default contrast level you have set by pressing the Contrast button on top of the pump Pressing a function button while in Auto dim mode will restor
114. t your insulin If you are ill and cannot eat your need for insulin continues and may also increase e Continue your usual basal dose of insulin along with bolus insulin to cover food eaten or to correct high blood glucose as prearranged with your healthcare team e You may need to temporarily increase or decrease your basal rate by using the Temp Basal feature as prearranged with your healthcare team Medication Always let your healthcare team know ALL medications you are taking Blood and Urine Testing e Check your BG before your usual mealtime and every 2 4 hours if indicated e Test your blood or urine for Ketones at least 4 times a day or according to instructions from your healthcare team Fluids and Diet Always follow your healthcare team s sick day guidelines Fluid intake is essential with any illness You may need to drink 8 ounces of calorie free liquid every 60 minutes Examples of calorie free items are water tea without sugar instant broth sugar free drinks OR eat ice chips sugar free Popsicles sugar free gelatin etc If vomiting start fluids 1 to 2 hours after vomiting and sip slowly Increase the frequency of BG testing to every 2 to 4 hours as long as BG is elevated If BG is over 250 check for ketones every 4 hours until negative results are obtained Page 93 Page 94 Chapter 17 Lifestyle Issues Exercise and Sports There are many options for wearing your pump during exercise and sports activitie
115. t your local Animas distributor FOOD INTAKE Bolus too large Check bolus amounts and times Bolus only enough to lower your BG to normal level Do not be aggressive with 2 3 hour after meal BG correction boluses unless you are ill Low carbohydrate intake for bolus Measure carbohydrates accurately See dietitian for carb counting review May need recalculation of Insulin to Carbohydrate ratio I C consult with healthcare team Improper timing of bolus Match timing of bolus with intake of food Check BG prior to meal bolus and adjust accordingly Page 87 Possible Cause of Low BG Suggested Solution Alcohol consumption May cause hypoglycemia Eat food when drinking alcohol Be cautious with bedtime bolus Always check BG before going to bed Check BG at 3 am Consult healthcare team ACTIVITY Did not Suspend pump or activate Consult healthcare team for guidelines for use of Temp Basal Temp Basal rate during exercise Low carbohydrate intake prior to If not decreasing insulin prior to exercise must eat foods exercise containing carbohydrate prior to exercise Unplanned activity shopping If BG is lt 100 mg dL 5 5 mmol L eat snack prior to exercise Frequent BG testing before during and after any activity Long or intensive exercise Effects of exercise can be present for hours after activity has stopped May need to decrease basal rate 1 2 hours prior to activity Consult with healthcare team for specific
116. that date Total Bolus for the date Total Basal for the date Total dose for the date 2 Scroll up to highlight the record field Press OK to activate Review Mode indicated by flashing cursor 3 Record 1 indicates the most recent record Use the Up Down arrows to scroll to other records 4 When finished reviewing press OK to exit Review Mode 5 History Menu is highlighted Press OK to return to History Menu History Menu Alarm History Your Animas 2020 displays the last 30 Alarm records 1 From the History Menu select Alarm The screen displays the following e Record number e Date of alarm e Time of alarm e Alarm Code e Alarm Type 2 Scroll up to highlight the record field Press OK to activate Review Mode indicated by flashing cursor 3 Record 1 indicates the most recent record Use the Up Down arrows to scroll to other records 4 When finished reviewing press OK to exit Review Mode 5 History Menu is highlighted Press OK to return to History Menu Empty Cartridge History Menu Page 48 Prime History Your Animas 2020 displays the last 60 Prime records 1 From the History Menu select Prime The screen displays the following e Record number e Date of prime e Time of prime e Amount of prime 2 Scroll up to highlight the record field Press OK to activate Review Mode indicated by flashing cursor 3 Record 1 indicates the most recent record Use the Up Down arrows to scroll
117. these alerts cannot be turned off gt Unless otherwise recommended by your healthcare professional vibrate mode should not be used during sleep If you are a very sound sleeper set the alarm volume to high before going to bed 1 From the Main Menu scroll to Setup Press the OK button 2 Scroll to Sound Press the OK button Reminder Vib 3 Use the Up Down arrows to scroll to your selection Press the OK button 4 The cursor will flash to indicate you can edit the selection Use Up Down arrows to change to desired setting Press the OK button to confirm 5 Repeat for remaining selections 6 Scroll to Next Menu to access second Setup Sound Menu or scroll to Main Menu when finished to return to the Setup Menu Page 29 The Cartridge Filling the Cartridge Refer to the Instructions for Use included with your cartridges Connecting the Tubing to the Cartridge These steps must be followed in order To complete this section you will need the following e Filled Animas 2 0 mL Cartridge 200 unit 2ml e Infusion set compatible with your Animas 2020 e Skin prep such as IV Prep Efficacy of pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used Note Only infusion sets marketed for use with insulin infusion pumps using insulin compatible tubing and with a standard Luer lock can be used with Animas pumps Efficacy of pump cannot be guaranteed if infusion sets
118. tification Refer to your ezManager User Guide included with the software Alert Active Basal Program Empty Empty basal program activated TET Effect No basal deliveries basal Displayed once for 3 seconds and each time manually hek awakened 0 000 U Hr None required but can confirm or select Basal Menu Message Oera ildan User selected one time and each time manually Beeps Vib awakened No progression Alert Temp Basal Minimum Rate Negative Temp Basal activated 7 Effect Basal delivery will not go below 0 025 U hr ee Basal rate Displayed once for 3 seconds limited to Aai Beeps Vib User selected one time No progression Page 81 Temp Active Alerts Warnings and Alarms Alert Suspend Temp Basal Combo Bolus Canceled Pump Suspended Pump suspended Effect Any active Temp Basal Combo Bolus canceled If active Bied for 3 d Temp Basal amp essage isplayed once for 3 seconds erb oiie Beeps Vib User selected one time No progression canceled Alert LowBG J BG entry below 70 mg dL LOW BG Effect Requires user confirmation to continue Treat low BG l No Bolus Displayed until Conen PNE PN Press OK to confirm Monitor BG Beeps Vib User selected one time and each time manually p awakened until confirmed No progression Alert High BG J BG entry above 250 mg dL HIGH BG Effect Requires user confirmation to continue Treat high BG Displayed until confirmed Check site f
119. time pump is awakened until confirmed 3 and once every 15 minutes until action is taken bede suspende Press OK to confirm Resume delivery j User selected once every 15 min No progression if Beeps Vib confirmed each time displayed Sweep vibe within Confirm mmm one hour if not confirmed Warning No Cartridge Detected Deliveries Disabled J No cartridge detected after Load cartridge step during Rewind Prime NO CARTRIDGE Effect No deliveries DETECTED Displayed until confirmed or until pump goes to sleep Deliveries Press OK to confirm Be sure Rewind Prime sequence Riese Action is completed with cartridge properly in place User selected once every 3 min No progression if Beeps Vib confirmed each time displayed Sweep vibe within one hour if not confirmed Page 83 Alerts Warnings and Alarms Warning Low Battery J Battery life ends in minimum 1 hour Warning Effect lon Displays when pump is awake until confirmed battery Message Displays when triggered by event such as bolus amp when manually awakened Press OK to confirm Insert new battery User selected every 3 minutes until confirmed If not Confirm mm Beeps Vib ae confirmed progresses to sweep vibe within one hour Warning Low Cartridge J Low insulin level reached Deliveries may continue until Empty Cartridge alarm Low Effect a cartridge is triggered U Displayed when manually awakened until confirmed ess lett
120. tinue until basal segments have been set as recommended by your healthcare team 10 When finished scroll to Save Review and press OK If you have edited the active program it is now resumed automatically The Basal Options screen is displayed Basal edit not saved Note If your screen display has timed out gone to sleep before you Basal have selected Save Review while editing a Warning screen will remind delivery you the basal edit has not been saved See Chapter 14 Safety System suspended and Alarms Edit Basal 11 Review is highlighted Press OK to review your entries for accuracy Your basal segment settings are shown 5 on first screen 5 on second screen and 2 on last screen If you have more than 5 segments programmed scroll to Next to see second and third screens as desired BASAL OPTIONS 12 Options is highlighted Press OK The Basal Options screen is displayed a If youve edited and saved reviewed the active program it is resumed automatically You can also select Go and the Home screen is displayed which shows the current rate of delivery for the program that is active b If youve edited an inactive program and wish to activate it select Go from the Basal Options screen When you select Go the Home screen is displayed which shows the current Go rate of delivery for the program that is active Adding Changing Segments in an Existing Basal Program 1 From Basal Menu select desired program 2 Ed
121. tive Or you can simply wait for the pump display to time out When you press any button your active basal program rate information is displayed on the Home screen gt Always review changes to your basal program to be sure they are correct See next section Reviewing Basal Programs Reviewing Basal Programs 1 From Basal Menu scroll to highlight desired program Press OK A 1 WEEKDAY 13 60U 2 Scroll to Review from Basal Options screen Press OK Your basal segment settings are shown 5 on first screen 5 on second screen and 2 on last screen If you have more than 5 segments programmed scroll to Next to see second and third screens as desired 3 When finished Options is highlighted Press OK 4 Scroll to Main Menu and press OK The Main Menu screen is displayed The active basal program continues A1 WEEKDAY ae Total 13 60U 5 If reviewing an inactive program and you wish to activate it select the program you wish to activate from Basal Menu screen Press OK 6 Select Go from Basal Options screen to activate the program The Home screen is displayed to show the current rate per hour of the program you have activated Options Page 40 Clearing Basal Programs BASAL OPTIONS This feature allows you to clear all information from a basal program 1 From Basal Menu scroll to desired program 2 From Basal Options screen scroll to Clear Press OK If you press OK to select Clear your pump will check to be sur
122. tness for a particular purpose The remedies provided for in this warranty are the exclusive remedies available in the event of any breach hereof Except for such remedies Animas its suppliers and its distributors shall not be liable for any losses liabilities claims or damages of any kind or nature whatsoever including without limitation any indirect consequential incidental or special damages caused by or arising from a defect of the insulin pump Page 111 ANIMAS INSULIN PUMP ACCESSORY WARRANTY LIMITED PRODUCT WARRANTY FOR INSULIN PUMP ACCESSORIES Cases Clips Skins etc Your Animas insulin pump accessory is warranted against defects in materials and workmanship for a period of THREE 3 MONTHS from the date of original retail purchase If a defect exists Animas Corporation at its option and to the extent permitted by law will 1 repair the product at no charge using new or refurbished parts 2 exchange the product with a functionally equivalent product that is new or refurbished or 3 refund the original purchase price This warranty is available only to the original retail purchaser and excludes damage resulting from abuse accident modifications or other causes that are not defects in materials and workmanship TO THE EXTENT PERMITTED BY APPLICABLE LAW ANIMAS IS NOT LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THE USE OR SERVICE OF THE PRODUCT THE WARRANTY AND REMEDIES DESCRIBE
123. to other records 4 When finished reviewing press OK to exit Review Mode 5 History Menu is highlighted Press OK to return to History Menu HISTORY PRIME PRIME Mar 23 2003 Mar 23 2003 1 15PM 1 13PM Fill Cannula Primed Total 1 0U Total 23 7U History Menu History Menu Suspend History Your Animas 2020 displays the last 30 Suspend records 1 From the History Menu select Suspend The screen displays the following e Record number e Date and time pump delivery was suspended e Date and time pump delivery was resumed 2 Scroll up to highlight the record field Press OK to activate Review Mode indicated by flashing cursor 3 Record 1 indicates the most recent record Use the Up Down arrows to scroll to other records Mar 23 2003 1 13PM Resumed 5 History Menu is highlighted Press OK to return to History Menu ed res a History Menu 4 When finished reviewing press OK to exit Review Mode Page 49 Basal History Your Animas 2020 displays the last 270 Basal delivery records 1 From the History Menu select Basal The screen displays the following e Record number e Date and time basal rate was changed e Basal rate change 2 Scroll up to highlight the record field Press OK to activate Review Mode indicated by flashing cursor 2 Mar 23 2003 3 Record 1 indicates the most recent record Use the Up Down 4 13PM arrows to scroll to other records Rate 0 67 4 When finishe
124. tromagnets 13 empty cartridge alarm 86 exceeds insulin remaining warning 85 exceeds max basal warning 85 exceeds max bolus warning 84 exceeds max tdd warning 84 exercise and sports 95 extended bolus see combo bolus ezbg 65 72 ezbg bolus 56 ezBolus 22 55 63 65 ezcarb 15 65 66 70 77 general anesthesia 11 help 8 high bg alert 82 high blood sugar 88 95 history feature 47 home screen 23 hyperglycemia 88 91 hypoglycemia 61 88 infusion set 30 89 insulin limits 56 insulin on board 15 72 77 78 insulin on board setting 61 intimacy 96 ir infra red 14 language setup 57 laser surgery on the eye 11 locked 23 low battery warning 84 low bg alert 82 low cartridge 64 low cartridge warning 84 low cartridge warning setting 58 magnets 10 main menu screen 24 maintenance 79 mri 10 multiple basal programs 37 41 77 no cartridge detected deliveries disabled warning 83 no prime no delivery warning 85 nuclear stress test 11 occlusion alarm 85 occlusion sensitivity setting 58 O ring 13 22 26 pacemaker 11 precautions 13 primary vent 22 prime history 49 prime rewind 24 priming the pump 31 programming buttons 21 pump support department 2 8 9 16 80 radiology equipment 10 rechargeable batteries 16 25 reminders 65 75 replace battery alarm 86 replacement pump 16 rf welders 10 roller coasters 13 safety information 14 serial number 7 setting changing the time and date 27 sounds
125. ttempt to power your Animas 2020 pump with a high energy 3 6V AA Lithium battery Use of these batteries could permanently damage the pump and voids its warranty Note Your pump uses battery power to notify you of reminders alerts warnings and alarms If you do not confirm the notification your pump will continue to use battery power as the notifications repeat and progress This will result in reduced battery life and the Replace Battery Alarm screen appearing sooner than expected Page 25 Additionally certain warnings e g Empty Cartridge Alarm take precedence over less critical ones e g Low Battery Warning This means if you do not confirm the more critical warning battery life will be reduced and your pump may skip the Low Battery Warning and go directly to the Replace Battery Alarm or the battery life will end before a Replace Battery Alarm is displayed Changing the Battery Each time you change the battery e A full rewind and prime sequence is required See this section Priming the Pump and Infusion Set e The Insulin on Board calculation starts over at zero e The Combo bolus returns to the factory set default duration and split e Review your basal program settings gt Low Battery Warning means battery life will end in minimum 1 hour 1 Use a coin to unscrew the battery cap with a counter clockwise motion 2 Check your battery cap for damage such as cracks or missing threads and be sure the colored yellow o ring
126. wn arrows to scroll to the BG units field 2 Press OK to change to flashing cursor for Edit mode Use the Up Down arrows to change to desired setting 3 4 Press OK when setting is made 5 To move to the next ISF screen scroll to the forward arrows and press OK 6 Scroll up to the time field and press OK to change to flashing cursor for Edit mode Page 59 7 Use the Up Down arrows to change the segment start time Press OK 8 Scroll to the BG units field and press OK to change to flashing cursor for Edit Mode 9 Use the Up Down arrows to change the BG units field as desired Press OK Repeat to set remaining segments per your healthcare team s recommendations To review your settings highlight the forward arrows and press OK to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press OK to return to the Setup Adv screen To return to the Home screen scroll to Home and press OK Setup Advanced 7 Personal Settings BG Target Ranges Your healthcare team may recommend you use different BG Target Ranges for different times of day When you use the ezCarb feature or ezBG your pump will automatically select the BG Target Range for the current time of day gt By setting a range the pump will not calculate a correction dose if your actual BG is within that range If you prefer to correct to one target number rather than a range simply set your range to

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