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Animas Vibe Insulin Pump User Guide

1. 31 RF activation X 85 87 RF commu lnicationh ca eode X RF interference X RE cs 155 Rise rate alert CGM 92 111 133 Roller coastets retten VII S Safety information CGM IX X 127 Safety information insulin pump III VI VII VIII 73 Sensor CGM Ill X 85 95 97 123 125 Sensor 95 97 Sensor 125 Serial number CGM transmitter 41 87 88 Serial number insulin XIII 1 4 Setting the time and 11 Set up advanced features insulin pump 43 Set up basic insulin pump 11 Setup COM 87 Sick day guidelines 55 72 157 Sounds 12 13 73 Sounds setting CGM 5 12 89 90 91 Sounds setting changing insulin delivery 12 Starting a CGM 5 55 103 Status feat te eee 39 Snooze alerts CGM 90 91 Snooze times
2. 3 4 57 59 Bolus ezBG icc VII 48 53 59 65 Bolus 2 VII 48 53 59 60 62 Bolus MiStOry 2 4220 heed eve Bee 33 Bolus 21 Bolus delivery 48 71 Bolus insulin limits essseeeees 49 Bone lt V BUTONS HC 3 Calculator feature 59 Calibrating the CGM 63 66 105 154 Call service alarm insulin delivery 83 Cancel a 21 Carb see ezCarb Carbon zinc VIII 9 Cardiac IV Cartridge I VI VIII 5 14 15 16 17 19 Cell pliori8s esset etr beet VIII X CGM 85 CGM 114 127 CGM 89 127 CGM alerts fall 92 111 133 CGM alerts high glucose 91 110 132 CGM alerts low glucose 92 110 132 CGM alerts out of range transmitter 93 104 134 CGM alerts rise
3. 141 Clear program basal segments alert 27 76 IV Combo VII 40 48 59 68 Completing a CGM 55 123 183 Contrast button CGM shortcut 3 4 50 110 Correction see ezBG CI rep IV ICLP 1 High altitude activities 159 D High BG alert CGM 91 110 132 High BG alert insulin 75 Daily insulin limits eiirus 49 High blood glucose BG IX 114 115 149 150 151 IV VI VIII X 2 4 9 10 14 History a 119 15 19 97 142 156 159 160 History insulin 33 Data screen CGM 110 Home screen sess 6 Date te nere Ce ie 11 Hyperglycaemia Il 29 59 149 150 151 Daylight saving time 12 14 16 17 29 Dehydration 157 160 59 147 148 149 Delivery speed 48
4. 90 91 92 93 Status feature 39 Supply reordering XV Suspend temp basal combo bolus canceled alert 74 Suspend 36 Suspend insulin 31 Suspend warning 77 Sweep tone Hibernie 73 Swimming sssssssssse 101 159 Symbols CGM 5 110 112 Symbols CGM packaging XIV Symbols insulin pump packaging XIII 185 Tamper resistant Locked feature 6 TDD total daily dose insulin limits 49 Technical and clinical 1 Technical specifications CGM 174 Technical specifications insulin pump 167 Temp basal udo epos o to ER eee 27 28 Temp basal minimum rate 74 Temperature a VIII 143 Temporary basal feature see Temp basal Therapeutic oncology Therapeutic radiation Time formata E 12 6 11 50 Total daily dose
5. 92 111 133 CGM alerts 89 CGM 63 66 105 154 CGM data screen 110 NISTON 119 CGM history 121 CGM history BG 120 CGM history CGM session 119 CGM safety information Ill IX X 127 CGM screens CGM data 110 CGM screens CGM trend 110 CGM setup es ha 87 CGM sensor IX X 85 95 97 123 125 CGM session start 119 CGM snooze 90 91 CGM snooze 90 91 92 93 CGM startup 103 CGM transmitter 85 95 96 97 125 CGM trend 110 111 CGM trend graph screen 110 CGM isse tte Ete dens 89 127 Changing the battery insulin pump 10 Changing the insulin cartridge 15 19 Cleaning your CGM transmitter sensor 142 143 Cleaning your insulin
6. 3 4 52 57 Audio bolus delivery step 5 52 ce 4 50 Auto off alarm eene hene 83 Auto off featulte 2 5 eoe mr tee 51 B Basal delivery suspended warning 76 Basal hiStoty 37 Basal insulin 49 Basal program 23 Basal program reviewing 26 Basal program temp 27 28 Basic set up insulin 11 Batteries CGM lt 96 137 Batteries insulin 9 Battery cap vent insulin pump 5 10 141 Battery insertion insulin 10 BG calibration CGM 63 66 105 154 BG calibration history 120 BG check 70 BG correction see ezBG BG targets ranges insulin 45 Body V Bolus 10 3 4 52 57 Bolus VII 40 48 59 68 Bolus 2
7. GB To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight gt Press To return to the Home screen scroll to Home and press Setup Advanced Screen 6 Low Cartridge Warning Setting and Occlusion Sensitivity Setting You can program your pump to alert you when your insulin cartridge is running low The occlusion detection is automatic A blockage may restrict the flow of insulin into your body This screen allows you to Set your low cartridge warning to alert you at 10 20 30 40 or 50 units remaining in the cartridge You can set your pump to detect a blockage with high sensitivity or low sensitivity L The sensitivity level refers to how quickly the pump will sense back pressure from an occlusion in the infusion line with H meaning more sensitive and L meaning less sensitive Review the Occlusion Sensitivity setting with your health care team and see page 168 for more information 1 From the SETUP ADV 6 screen scroll to the desired field 2 Press Q to change to flashing cursor for Edit mode Use the O O buttons to change to desired setting Low Cartridge 4 Press when setting is made Warning To move to the next Setup Advanced screen scroll to the bottom of the Occlusion screen and highlight gt Press Sensitivity To return to the Home screen scroll to Home and press 51 m CHAPTER 9 ADVANC
8. ic highl fedi Food List 2 Add BG is highlighted Press Qj The BG CORRECT screen is displayed Review Total NOTE Show Result Do Not enter CGM readings as BG values CGM readings should never be used to make insulin dosing or other treatment decisions Always verify BG levels with a BG meter e The Food List option on ezCarb Home screen is not yet operational with the Animas Vibe Insulin Pump you received with this Owner s Booklet 3 The Actual field is highlighted and flashing BG CORRECT BG CORRECT to indicate Edit mode Use the buttons to enter your current Active BG value Press Q9 Show Result is highlighted ISF 2 1 mmol L Show Result Show Result 4 Check that the BG Target and ISF are correct a If they are correct press with Show Result BG CORRECT BG CORRECT Ohl mmol L highlighted t b If they are not correct scroll up to highlight the See fields and press Use the buttons to adjust ISF 2 1 mmol L ISF the values Press to exit Edit mode Scroll down to Show Result Press m CHAPTER 10 USING ADVANCED FEATURES 5 The Bolus Total screen is displayed and the suggested calculated bolus amount from your ezCarb Bolus appears in the Total field Above the Total field are the three parts that are used in calculating the Total suggested amount Carb refers to the carb correction amount BG refers to the BG corre
9. 147 148 149 F Low CHR REC ao oir renes Peri re atre tiia 51 Low cartridge amp 52 78 Fall rate alert CGM 92 111 133 Low cartridge warning amp 51 184 M Magnets VII Main menu Screen 6 7 Maintenance 142 Maintenance insulin 141 Mammogram ee V Max basal insulin 49 Max bolus insulin limits 49 Max daily insulin 49 Max TDD insulin 49 2 hour insulin limits 49 Medical IV Missing CGM 115 Ill IV IX Multiple basal programs 23 48 71 N No cartridge detected deliveries disabled warning 77 No prime no delivery warning 80 Normal bolus 21 Nuclear stress IV 6 6 81 Occlusion sensitivity
10. Accessories e Maintain your fingerstick BG meter as directed by the manufacturer Only use Dexcom supplied parts CGM Sensors and Transmitters with your Animas Vibe System Do Not use Sensors and Transmitters from other companies Storage CGM Sensor e Keep the CGM Sensor in its sterile packaging until you are ready to use it Do Not insert CGM Sensors past the expiration date printed on the CGM Sensor packaging e Store at room temperature for the length of its shelf life CGM Transmitter Keep the CGM Transmitter clean and protected when not in use e CGM Transmitter Warranty is 6 months e Storage Temperature should be 2 45 C 36 113 P Cleaning Cleaning the CGM Transmitter 1 Use alcohol wipe or equivalent to clean the CGM Transmitter Avoid wipes containing adhesive properties e g Smith amp Nephew IV Prep 2 Place the CGM Transmitter on a clean dry cloth and air dry for 2 3 minutes Disposal The CGM Sensor may be discarded after removal If you have any problems with the CGM Sensor save it and contact Customer Support or your local Animas distributor see page 187 before discarding International regulations require controlled disposal of devices such as Transmitters Contact Customer Support or your local Animas distributor see page 187 for disposal instructions Your CGM transmitter contains a small battery Dispose of batteries according to your local environmental r
11. INSULIN POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Cloudy clumpy crystallized or expired insulin or insulin exposed to extreme temperatures Remove infusion set and cartridge and discard Use new vial of insulin FOOD INTAKE POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Bolus insufficient or omitted Review carbohydrate counting and ratio settings High protein or fat intake Consult dietitian may need to count protein and fat Long meal continuous snacking slowly absorbed food high fiber delayed digestion gastroparesis Consult health care team May need to use extended bolus or combination bolus option Improper bolus timing Consult health care team Maintenance amp Technical Information D 150 me CHAPTER 3 TROUBLESHOOTING GUIDELINES mum Troubleshooting hyperglycemia ACTIVITY POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Less activity Use Temp Basal increase Consult health care team Record amount of time for changes fT B ducti Frequent BG testing document changes BG will increase with exercise when ketones are present Do Not exercise when ketones are present Consult health care team for exercise guidelines BG higher than 13 9 mmol L with ketones before exercise A CAUTION Infusion set should be changed every 2 to 3 days or as recommended by your health care team Always use clean technique Not
12. 81 OI VI 5 10 15 141 Out of range alert 93 104 134 P Pacemaker Primary 5 Prime history Er e dete ee ide 35 Prime rewind 2 etes Ill 16 Priming the DUMP 16 Programming 3 73 127 P mp alerts v d 73 127 Pump Nisto iioi eec i eter es 33 Pump history 35 Pump history 37 history bolus eater 33 Pump history 35 Pump history 36 Pump history total daily dose TDD 34 Pump safety information VI VIII 73 Pump status serie trei bei b 39 Pump warnings ss 73 127 R Radio Frequency RF X Xl 87 95 155 Radiology Rechargeable batteries insulin pump VIII 9 Remilriders dotted 48 59 69 Removing the CGM sensor transmitter 125 Replace battery alarm insulin pump 82 Replacement VIII 160 Resume insulin
13. If your current BG is above your target range and your IOB amount is greater than your BG correction amount then your suggested total bolus amount will be your Carb Correction amount This is illustrated in example 1 that follows If your current BG is within your target range or equal to your target value your suggested total bolus amount will be your Carb correction If your current BG is below your target range your suggested total bolus amount will be your Carb correction amount plus your BG correction amount minus your IOB amount The suggested total bolus amount will be 0 00U whenever the calculation results in a negative number A negative number implies that any additional insulin bolus amount would potentially result in over delivery of insulin and hypoglycaemia Discuss the calculator feature with your health care professional so you have thorough understanding of how it works before you begin using it The following examples illustrate typical screens you may encounter when using the ezCarb feature with activated Bolus Total Example 1 In Example 1 the amount is displayed for reference but is not applied to the suggested total bolus amount In this case even though your current BG level is above the target range there is sufficient to cover the high BG Therefore the only insulin amount suggested is to cover the carbs being consumed In Example 2 the IOB amount is displayed for reference and i
14. me CHAPTER 10 USING ADVANCED FEATURES The Time field for this reminder will be highlighted Press to activate Edit mode Use the buttons 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 to confirm your setting and exit Edit mode When the feature is turned on your pump will display the Reminder screen on the right at the selected time of day 4 Repeat for Reminder 2 Reminder 1 Time Reminder 2 Time 12 00AM BG Check After Bolus 1Hr Reminder 12 00AM Confirm BG Check Reminder Animas Vibe Insulin Pump 1 From the REMINDERS menu select BG Check to remind you to check your BG Press to activate Edit mode to turn this reminder on or off Press to confirm and exit Edit mode Reminder 1 Time Reminder 2 Time 12 00AM NOTE The BG Check reminder you set here is independent of the Enter BG prompts you will see when using your pump with the CGM see Section II pages 85 140 BG Check After Bolus Reminder 1 OFF Time 12 00AM Reminder 2 OFF 12 00AM 2 Scroll down to highlight the After Bolus field Press to select the field and activate Edit mode Use the Q buttons to enter how long after a Normal Bolus you wish your pump to sound or vibrate to remind you to check your BG You can select a reminder time of 1 2 3 or 4 hours Time BG
15. minutes pump after you first confirm the alert if the condition causing the original Enable alert has not been resolved You may set a snooze time from 0 to 300 Yes CGM Setup minutes default is O minutes no re alert in 30 minute increments High Alert Warn above 4 Scroll to the Enable field and press to enter edit mode The Enable Ed DEM setting gives you the option to display sound the High Alert on your pump 0 minutes whenever the last CGM reading falls at or above this level When you select Enable this feature is disabled so that High Alerts will not display sound on CGM Setup your pump The default setting is Yes enable 5 When you are finished scroll to CGM Setup and press to return to the CGM Setup screen me CHAPTER 2 CGM SETTINGS Low Alert Dexcom CGM 6 Scroll to Low Alert on the CGM Setup screen and repeat these steps Wart g mmol L for the Low Glucose Alert You may set the Low Alert from 3 3 mmol L to Snooze time 5 5 mmol L default is 4 4 mmol L in 0 5 mmol L increments the snooze 60 minutes time from 0 to 300 minutes default is minutes no re alert in 30 minute EE increments and either enable or disable default is Yes enable the Low CGM Setup Alert When you are finished scroll to CGM Setup and press to return to the CGM Setup screen NOTE The High and Low Glucose Alerts that are set here will appear as
16. CGM Alert Dexcom CGM If there is no active CGM session CGM Warning screen will appear to remind you CGM Session Not Active Last BG Calibration History This selection displays the date time and value of the last BG calibration entered in your pump CGM History Session Start Last BG Cal Warnings 1 From the CGM History screen scroll to Last BG Cal Press Q9 Bend i The BG value date and time of your last BG calibration will appear on the 17 Dec 2010 display Only your last current BG calibration record is available for viewing 02 52PM To return to the CGM History screen highlight CGM History on any BG BEC ES Calibration record screen and press Q9 mmol L CGM History 120 CHAPTER 7 CGM HISTORY SCREENS CGM Alert History This selection displays the date time alert code and description of your last 300 CGM alerts CGM History 1 From the CGM History screen scroll to Warnings Press Q9 Session Start Last BG Cal Warnings Record 1 The CGM Warnings screen will be displayed and CGM History will be 17 Dec 2010 highlighted The most recent CGM Alert record will be displayed along with 12 17 PM the date time code and description of the alert 206 00000000 0000000000 Transmitter Dut of Range CGM History NSO Record 2 To go to other Alarm records first scroll to the Record field at the top 17 D
17. Duration 4 0Hr BOLUS ACTIVE Normal Extend 30 70 Basal Rate 2 55 5 950 0 675U Hr Insulin 105U Status To cancel an active Combo Bolus from the BOLUS MENU select Combo ACTIVE Bolus Details of the active Combo Bolus will be displayed Duration 0 0 4 0Hrs Scroll to CANCEL and press to cancel the Combo Bolus Delivered 2 550 8 50U CANCEL NOTE If you Suspend your 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 your pump dung uinsu aqra Reminders This feature allows you to set personal reminders if you have activated the Reminders feature see Setup Advanced Screen 2 in Chapter 9 in Section 1 page 48 You can set two separate reminders to prompt you at two designated times during the day and one reminder to check BG at a certain time after a bolus Confirm the Reminder by pressing Once you have confirmed the Reminder you will not be alerted again Bolus Reminders for Time of Day BOLUS MENU Normal 1 From the BOLUS MENU select Reminders Press ezCarb ezBG Combo Bolus Reminders 2 The Reminder 1 field will be highlighted with a flashing cursor to indicate Reminder 1 Edit mode Use the buttons to turn on or off Press to confirm and Time 12 00AM exit Edit mode Reminder 2 OFF Time 12 00AM BG Check After Bolus
18. Glucose Level is N52 Rising Too Quickly Message Displayed each time pump is awakened until confirmed Action Press to confirm Check BG with fingerstick test User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression 133 mew CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning Invalid Transmitter ID Invalid Transmitter ID Serial Number entered in pump is not Transmitter valid ID effect Insulin deliveries continue CGM does not start Displayed until confirmed or until pump goes into sleep mode Press to re enter the correct ID or select Cancel and press to return to the CGM Menu Refer to Chapter 2 in Section Il pages 87 94 for information on entering the ID number Beeps Vib User selected under CGM Setup menu options one time No progression Warning Pump and CGM Sensor Transmitter Not Within RF range Pump and CGM Sensor Transmitter are not within Transmitter Out of Cauda 3 6 meters 12 feet of each other Pump is unable to Range receive CGM readings and CGM Sensor Transmitter is unable to receive BG values for calibration mE Confirm Insulin deliveries continue CGM data gap for time period devices were not within RF range Displayed each time pump is awakened until confirmed Press to confirm Move devices closer and wait 10 minutes Us
19. 0 6 mmol L 13 Press when setting is made 14 Scroll to the range field Press 9 to change to flashing cursor for Edit mode 15 Use the buttons to change the range as desired Press Repeat to set remaining segments per your health care team s recommendations To review your settings highlight and press to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press to return to the SETUP ADV 1 screen To return to the Home screen scroll to Home and press m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Animas Vibe Insulin Pump L Setup Advanced Screen 2 Advanced Bolus Features and Multiple Basal Programs You can program your pump to increase the number of bolus types and basal program options available to you You can also program the speed of bolus insulin delivery and choose to turn the personal Reminders feature on or off This screen allows you to BOLUS e Turn Advanced Bolus Features ezCarb ezBG Combo Bolus on or off Adv Bolus OFF Reminders OFF Turn personal Reminders feature on or off Delivery NRML BASAL Select bolus delivery speed NRML normal 10 every second Programs or SLOW 1U every 5 seconds NOTE Users may experience a slight stinging sensation with normal bolus delivery If this occurs changing the bolus delivery speed to SLOW may reduce the stin
20. CONTINUOUS GLUCOSE MONITORING CGM CHAPTER 1 CGM Overview 85 CHAPTER 2 CGM settings 87 CHAPTER 3 Inserting the CGM Sensor and Transmitter 95 CHAPTER 4 Starting a CGM session 103 CHAPTER 5 CGM calibration 105 CHAPTER 6 Viewing CGM information on your pump 109 CHAPTER 7 CGM history screens 119 CHAPTER 8 Completing a CGM session 123 CHAPTER 9 Removing the CGM Transmitter and Sensor 125 CHAPTER 10 CGM Safety System and Alerts 127 SECTION CARE AND MAINTENANCE AND OTHER TECHNICAL INFORMATION ABOUT YOUR ANIMAS VIBE SYSTEM CHAPTER 1 Care and maintenance 141 CHAPTER 2 Lens protection film application instructions 145 CHAPTER 3 Troubleshooting guidelines 147 CHAPTER 4 Sick day guidelines 157 CHAPTER 5 Lifestyle issues 159 CHAPTER 6 My information 161 CHAPTER 7 Warranty and other technical information 165 Appendix A Glossary 177 Index 183 Animas Distributor Contact Information 187 mw BEFORE YOU BEGIN m m Check with your health care professional regarding your individual training needs Do Not attempt to connect to your pump before you have been trained on your pump As part of your training your health care professional will assist you in making the appropriate selections for your insulin pump and continuous glucose monitoring CGM settings Your insulin pump must be programmed for your own personal use as your insulin pump settings impact the calculations for insulin delivery Be comfortable
21. 1 Place the Sensor Pod on a table 2 Hold the rounded edge of the Safety Lock Transmitter Key 3 Make sure the jagged edge of the Safety Lock Transmitter Key is facing down the direction away from the removal arrow as shown below Safety Lock Transmitter Key from Applicator Sensor Pod with CGM Transmitter snapped in 4 Insert the jagged edges so that they hug the CGM Transmitter wings in the Sensor Pod Press the Safety Lock Transmitter Key down until you cannot press down anymore and the CGM Transmitter wings will pop out of the Sensor Pod 5 Remove the CGM Transmitter and store it in a cool dry place until your next CGM session 125 9 NSO HE Dexcom CGM CHAPTER 9 REMOVING THE CGM TRANSMITTER AND SENSOR mem Method 2 If you did not save the Safety Lock Transmitter Key you can simply use your pointer finger on each hand to spread out the tabs at the back of the Sensor Pod end closest to the wings The CGM Transmitter wings will out of the Sensor Pod NOTE Remember to save your Transmitter after each CGM Sensor removal The same Transmitter is used for each CGM session until you have reached the end of the CGM Transmitter battery life The Sensor can be thrown in the trash but if you have problems with the CGM Sensor save it and contact Customer Support or your local Animas distributor In the United Kingdom call free phone 0800 0
22. 71 Dental eee V Diabetic 5 149 157 Display conttast scie eta eie a eee 4 50 ID number CGM 87 Display 6 50 Infusion IV VI VIII X 5 14 Display timeout setting 50 15 16 17 18 19 Disposal batteries 142 143 Inserting a CGM 95 97 Disposal 143 Insulin cartridge 1 VI 5 14 15 16 17 19 Disposal insulin 142 Insulin limits erret erret 49 M RI M UE 149 157 Insulin on board VII 53 64 65 67 Download feature VI 5 33 59 85 119 Insulin on board IOB setting 45 53 54 59 Insulin sensitivity factor ISF 44 45 E Insulin to carb 43 45 Intended use ioter Edit MOIE cians 3 Inu 160 dic EXEAT IV IR infrared IR 5 Electr ca tery IV Electromagnetic 105 Il VII K Electromagnel
23. Food List option which is not yet operational with the Animas Vibe Insulin Pump you received with this Owner s Booklet Check that the grams of carb entered and your I C ratio at the top of the screen are correct Actual a If the entries are correct scroll to Show Result Press and go to Step 5 Food List Review Total b If not correct scroll up to highlight the field and press to activate Edit Mode Use O O buttons to enter your I C ratio and or change the carb entry Show Result Press Scroll down to Show Result Press m CHAPTER 10 USING ADVANCED FEATURES 5 The Bolus Total screen is displayed and the suggested calculated bolus amount from your ezCarb Bolus appears in the Total field Above the Total field are the three parts that are used in calculating the suggested Total amount Carb refers to the carb correction amount that was calculated to cover the carbs you manually entered BG refers to any BG correction bolus you may have added In this example you did not add a BG correction so the BG amount is set to 0 001 IOB refers to the IOB amount from a previous bolus In this example the IOB feature is not turned on so dashes appear instead of a number Below the suggested Total amount is the bolus amount entry field where you can choose to deliver the suggested amount or adjust the amount as needed This field will display 0 000 and will be highlighted and flash
24. If not confirmed progresses to sweep vib within one hour Once confirmed No Prime warning triggered see No Prime Warning screen page 80 Beeps Vib m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mm Animas Vibe Insulin Pump LES Section Ill Continuous Glucose Monitoring CGM 1 Section of this Owner s Booklet covers instructions for using the Dexcom continuous glucose monitoring CGM components in conjunction with your Animas Vibe Insulin Pump The Dexcom CGM is an optional system including a Sensor and Transmitter that can be added to your Animas Vibe Insulin Pump to provide continuous glucose monitoring CGM reporting on your pump The Dexcom CGM is packaged and available separately In addition to providing continuous insulin delivery your Animas Vibe System is designed to perform continuous glucose monitoring when used in conjunction with the Dexcom CGM Once you have completed training on your Animas Vibe Insulin Pump and the Dexcom CGM and have activated the RF communication link between them your Animas Vibe System can provide an integrated approach to managing your glucose levels The Dexcom CGM consists of a Dexcom G4 Sensor Dexsensor and Dexcom G4 Transmitter Dexmitter The Sensor is a disposable unit that you insert into your abdomen belly to continuously monitor your glucose levels for up to 7 days The Transmitter is a reusable device that snaps into your
25. Replace with filled cartridge User selected every 3 minutes until confirmed If not Beeps Vib confirmed progresses to sweep vib within one hour Warning Exceeds Max Bolus Cause Audio bolus delivery exceeds user set maximum Exceeds max bolus XX XX U No audio or combo bolus delivery Confirm effect Bolus delivery stops Displayed when manually awakened until confirmed Press to confirm Reprogram max bolus amount in the Setup Advanced menu Beeps Vib User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour 78 m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mM Alerts Warnings and Alarms Warning Exceeds TDD Cause Displayed when manually awakened until confirmed Beeps Vib Bolus delivery exceeds user set maximum Total Daily Dose TDD All insulin deliveries stop Any Combo Bolus or Temp Basal is canceled Press to confirm Reprogram max TDD amount in the Setup Advanced menu If the Warning is not confirmed by the time your pump clock passes midnight the message will continue to be displayed User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour Warning Exceeds Max 2 hour Delivery Displayed when manually awakened until confirmed Beeps Vib NOTE If the Exceeds Max TDD or the Exceeds Max 2 hour Delivery warning appears and is not confi
26. TDD 34 Total daily dose TDD insulin limits 49 Transmitter attaching 100 Transmitter CGM 85 95 96 97 125 Transmitter ID 87 Transmitter 125 Traveling ic cere erret Gebers 159 160 Trend graph screen CGM 110 Two hour CGM startup 103 Two hour 2 hr insulin 49 Troubleshooting 147 U Ultra S OU TIG occ optet tci V Wake up screen insulin 6 Warning messages 127 Warning messages insulin delivery 73 Warranty CGM 175 Warranty insulin pump and accessories 165 Water protector CGM 101 142 Waterproof insulin VI VIII 4 10 141 142 154 Wireless download VI X V 160 186 Austria Medtrust Handelsges m b H Gewerbepark 10 7221 Marz Austria Tel 43 02626 64190 Fax 43 02626 64190 77 Email office medtrust at Web www medtrust at Czech Republic A IMPORT CZ r o Petr
27. Use BG For CGM Calibration Must Be A Fingerstick NOTE f you enter a BG amount below 3 9 mmol L or above 13 9 mmol L your pump will alert you that LOW BG you have entered an out of range BG To confirm Treat low BG BG the Alert press Your pump will still use the out of range BG value in ezCarb and ezBG bolus Monitor BG ketones calculations but treat the out of range BG as Monitor BG recommended by your health care team Confirm O The LOW BG and HIGH BG Alerts discussed here are different than the Low and High Glucose Alerts that apply only to CGM readings See Chapter 2 in Section Il pages 87 94 for more information on CGM Alerts mew CHAPTER 10 USING ADVANCED FEATURES mm ezBG Examples with the IOB Feature Activated If the feature is activated your amount will be displayed for reference on the ezBG Total screen With the IOB feature activated your suggested ezBG total bolus amount will be as follows e f your current BG is above your target range and your BG correction amount is greater than your IOB amount the suggested total bolus will be your BG correction amount minus your IOB amount This is illustrated in example 1 below e n all other situations your suggested total bolus will be 0 000 The following examples illustrate typical screens you may encounter when using the ezBG feature with activated ezBG Total In Example 1 the IO
28. field Press to activate Edit mode indicated by flashing cursor Animas Vibe Insulin Pump 5 Use O O buttons to set desired basal rate Press to confirm and exit Edit mode for this field Tcr BASAL 6 Scroll down to select the next Start time field Press the button to Start activate Edit mode indicated by flashing cursor 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 EDIT BASAL 7 Change next Start time field as desired press the button to exit Edit mode Segments can start on the hour or half hour The end time of the current time segment is always assumed to be midnight NOTE The 24 hour Total changes automatically as you change U Hr settings m CHAPTER 5 USING BASAL PROGRAM FEATURES 8 Continue until basal segments have been set as recommended by your health care team 9 When finished scroll to Save Review and press Q9 If you have edited the active program it is now resumed automatically The BASAL OPTIONS screen is displayed Basal edit NOTE If your screen display has timed out gone to sleep or if an Ex Alarm Warning appears before you have selected Save Review while delivery editing a Warning screen will remind you the basal edit has not been suspended saved See Chapter 11 in Section pages 7
29. 1 mmol L NOTE Do Not enter CGM readings as BG values CGM readings should never be used to make insulin Show Result Show Result dosing or other treatment decisions Always verify BG levels with a fingerstick test from your BG meter aqra GB The difference between your current Actual BG BG Target appears below the Target field The difference is calculated according to whether your current Actual BG is within below or above your BG Target Refer to Setup Advanced Screen1 BG Target Ranges in Chapter 9 in Section 1 pages 43 56 for information on how your BG Target settings impact the calculation of a BG correction bolus 3 Check to be sure the BG Target and Insulin Sensitivity Factor ISF are correct Your health care team will give you these values If you need to edit these fields scroll up to highlight the field and press to activate Edit mode Use buttons to change target Press to confirm and to exit Edit mode 4 Show Result is highlighted Press 58 2 1 mmol L Show Result mew CHAPTER 10 USING ADVANCED FEATURES mE ezBG Total Animas Vibe Insulin Pump 5 The 67286 Total screen is displayed and the suggested bolus amount from your ezBG Bolus appears in the Total field Above the Total field are the two parts that are used in calculating the suggested Total amount BG refers to the BG correction amount calculated
30. CGM Sensor Sensor error indicating that Sensor is not functionin Cause 5 s Insulin properly Delivery Continues Insulin deliveries continue CGM data gap during MSS Confirm time periods Sensor was not functioning p Message Displayed each time pump is awakened until confirmed Press to confirm Wait 15 minutes and then enter at least one fingerstick BG value into the pump to recalibrate If no CGM readings appear after entering additional BG values Sensor should be replaced User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression Dexcom CGM Warning CGM Sensor Error 1 CGM Sensor Sensor error indicating that Sensor is not functioning Insulin properly Delivery Continues Insulin deliveries continue CGM data gap during Bue Confirm time periods Sensor was functioning Displayed each time pump is awakened until confirmed Press to confirm Wait one hour and then enter at least one fingerstick BG value into the pump to recalibrate If no CGM readings appear after entering additional BG values Sensor should be replaced User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression 136 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS mum Warning CGM Data Failure effect Insulin deliveries continue CGM sessio
31. FEATURES Animas Vibe Insulin Pump f you program a segment to start at the same time as an existing segment the previously entered segment is deleted f you 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 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 have edited an inactive program select the program from the BASAL MENU Press Select from the BASAL OPTIONS screen to activate the program you have selected When you select Go the Home screen is displayed which shows the current rate of delivery for the program that is active Or you can simply wait for your pump display to time out When you press any button your active basal program rate information is displayed on the Home screen A CAUTION Always review changes to your basal program to be sure they ar
32. However the CGM information displayed on your pump will help you understand the rate of change and direction your glucose level is moving like a video camera The CGM Sensor sits in the fluid under your skin not in your blood The CGM Sensor calculates a glucose reading from this fluid when you calibrate your CGM So the glucose reading may be different than the fingerstick result you get from your BG meter During an active session CGM readings will be sent from your CGM Transmitter to your pump every 5 minutes You may use your pump to view and analyze CGM data using the CGM Data and CGM Trend screens CGM readings between 2 2 and 22 2 mmol L will display as the actual value on CGM Data and CGM Trend screens CGM readings above 22 2 mmol L will display as HIGH and CGM readings below 2 2 mmol L will display as LOW on CGM Data and CGM Trend screens The screens provide important information about your current and previous CGM readings whether your CGM readings fall above or below High and Low Glucose Alert levels and whether your glucose levels may be rising or falling too fast It is important that you focus on the CGM trends and rate of change on your pump rather than a single CGM reading See Chapter 2 in Section Il pages 87 94 for CGM settings that impact how information is displayed on the CGM Data and CGM Trend screens WARNING Treatment decisions should not be based solely on results from the CGM You must confirm
33. ISM Band Transmitter Frequency Range 2 425 2 477 GHz Bandwidth 270 833 kHz Maximum Output Power 1 25 mW EIRP Modulation MSK Data Rate 50 kbps Total Packet 224 bits Duy oce 4 48 ms at each of 4 transmitter frequencies every 5 minutes Data Detection Range 3 6 meters 12 feet c 2 gt 2 O c 176 Appendix A Glossary alpha cells Alpha cells are found the pancreas They produce a hormone called glucagon which raises BG levels alternative site BG testing This is when you obtain BG values from somewhere on your body other than your fingertip Do Not use BG values from alternative site testing for CGM calibration applicator See CGM sensor applicator audio bolus Your pump has a special feature that lets you deliver a bolus without having to look at the screen display This feature is convenient if you wear your pump under your clothing Once you activate and program this feature you can use the soft rubber button on the right side of your pump to deliver a bolus 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 4096 to 6096 of the daily total delivery of insulin beta cells Beta cells are found in the pancreas They produce insulin which l
34. Multiple Basal Programs This feature allows 4 different Basal programs to show on your BASAL MENU screen Users find this feature beneficial if their activity level is different during the week than on weekends Switching work shifts at work is another reason to use multiple basal programs Some use a different basal program during menstruation An will appear to the left of the Basal program that is currently active 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 will pop up to remind you 08 Reminder Check BG Last bolus 12 15PM Confirm GB BASAL MENU Total 13 60U A1 WEEKDAY 3 weekend 4 exercise 1 weekday must be the active program to change the basal display setting Confirm Your pump constantly tracks IOB even if you have not activated the IOB feature If you have given a bolus and then activate the IOB feature your pump will show the remaining amount from that bolus as on ezCarb and ezBG calculator screens NOTE e When you replace the battery the IOB amount is cleared mew CHAPTER 10 USING ADVANCED FEATURES m Animas Vibe Insulin Pump Sick Day Guidelines To review your basic sick day guidelines refer to this screen For more information on sick day guidelines refer to Chapter 4 in Section Il
35. Place your thumb on top of the CGM Transmitter e Then squeeze together to make sure the CGM Transmitter has been snapped in Install CGM Transmitter CGM Transmitter Remove Transmitter in Sensor Pod Installed Latch Transmitter Latch NSO e Remove the Transmitter Latch by holding the end of the Latch and quickly twisting off the Latch away from your body Remember to keep the Safety Lock Transmitter Key NOTE Make sure you hear 2 clicks when you snap the CGM Transmitter in place see Step 6 This helps ensure your CGM Transmitter is water resistant Your CGM Sensor including the attached CGM Transmitter is water resistant when showering bathing or swimming The CGM Sensor Transmitter has been tested to be water resistant when submerged for up to 2 4 meters 8 feet for a maximum of 24 hours For added protection you can use a shower cover Make sure that you have the correct Transmitter ID Serial Number entered into your pump See Chapter 2 in Section II pages 87 94 for instructions on how to enter the Transmitter ID Serial Number into your pump e Refer to Chapter 3 in Section Ill pages 147 156 for troubleshooting problems with CGM Sensor insertion 101 m CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER Dexcom CGM 102 m CHAPTER 4 STARTING CGM SESSION 4 2 Startup Period Once your Sensor is inserted and your Transmitter ID Serial Number is
36. Startup BGs Insulin deliveries continue CGM does not start Confirm Displayed each time pump is awakened until M confirmed and action is taken NSO Press to confirm Take 2 fingerstick BG tests and enter values in pump Do Not enter a fingerstick BG value if ANT or appear on the CGM Trend or Data screen User selected under CGM Setup menu options Beeps Vib every 3 minutes until confirmed If confirmed snooze for 15 minutes No progression 127 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning Second BG Value Required For 2 Hour Startup Calibration Enter Only 1 of the 2 required BG values has been entered E _ Cause in the pump following the 2 hour CGM startup Startup BGs session Insulin deliveries continue CGM does not start Message Displayed each time pump is awakened until 9 confirmed and action is taken Press to confirm Take fingerstick BG test and enter value in pump Do Not enter a fingerstick BG value if or appear on the CGM Trend or Data screen User selected under CGM Setup menu options Beeps Vib every 3 minutes until confirmed If confirmed snooze for 15 minutes No progression Warning BG Value Required For Calibration Update No BG values have been entered in the pump in the Cause last 12 hours Insulin deliveries continue CGM continues Confirm Message Displayed each time pump is awaken
37. Supply Reordering You can place orders for cartridges infusion sets skin prep batteries replacement battery caps and many pump accessories by calling Customer Support or your local Animas distributor 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 see page 187 To place orders for CGM supplies contact Customer Support or your local Animas distributor see page 187 Emergency Kit Keep an emergency kit with you at all times to make sure you have necessary supplies This kit should include but is not limited to e Quick acting glucose tablets or gel BG monitoring supplies including meter test strips lancing device lancets meter batteries Blood or urine ketone testing supplies Rapid acting and other insulin as recommended by your health care team e Extra infusion sets and Animas 2 0 mL Cartridges 200 unit 2ml Dressing and adhesive if used An extra Energizer Lithium Ultimate AA battery for your pump An extra pump battery cap An extra pump cartridge cap Glucagon Emergency Kit Emergency contact phone numbers A backup plan for obtaining and delivering insulin when you are unable to use your pump Be sure to inform a family member co worker and or friend where this emergency kit is kept Section Animas Vibe Insulin Pump m CHAPTER 1 INSULIN PUMP OVERVIEW m Section of thi
38. The pump default for sounds at the low volume setting is a factory set sound There is an additional list of warnings alarms and alerts that will display sound on your pump related to the use of CGM functions when you begin using your CGM with your pump See Chapter 10 in Section pages 127 140 for more information on this list NOTE Alarms warnings and alerts will display actual insulin units during pump operation rather than the or units displayed on some of the screens in this list m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Animas Vibe Insulin Pump L Alerts Warnings and Alarms Alert Active Basal Program Empty vourartive basal Cause Active basal program is empty program is empty effect No basal deliveries 0 000U Hr Displayed once until confirmed or until pump goes to Basal Menu Message sleep and each time manually awakened action None required but can confirm or select Basal Menu User selected one time and each time manually B i eeps Vib awakened No progression Alert Temp Basal Minimum Rate Temp Active Negative Temp Basal activated Minimum Basal rate limited to effect Basal delivery will not go below 0 025U Hr 0 025U Hr Displayed once for 4 seconds Action Wem OO Beeps Vib User selected one time No progression Alert Suspend Temp Basal Combo Bolus Canceled Pump Suspended Temp Basal amp Any active Temp Basal Combo Bolus
39. U Hr you can select in the Change field in the screen above This will set the temp basal rate to 0 0 U Hr for the duration selected 5 is highlighted Press to activate Temp Basal 6 The Home screen is displayed and shows your Temp Basalis active the percentage change the duration and how much time is left When the duration of time is complete your pump will automatically resume the active 0 07 TEMP BASAL basal program 40 4 0 Hr Time Left 3 2 Hr NOTE If you turned on the Temp Basal sound in Setup your pump will beep Insulin 105U once every 30 minutes to remind you of Temp Basal status Status m CHAPTER 5 USING BASAL PROGRAM FEATURES Canceling a Temporary Basal Program 1 From the BASAL MENU select TEMP BASAL Press Q9 2 Details of the current active Temp Basal program will be displayed Scroll up to CANCEL and press 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 A1 WEEKDAY TE
40. bring pump or CGM Transmitter Sensor into the same room PACEMAKER AICD where the procedure is being performed Reprograming e Teflon plastic infusion set can remain in Other types of infusion sets must be removed THERAPEUTIC RADIATION Do Not bring pump or CGM Transmitter Sensor into the same room ONCOLOGY where the procedure is being performed cancer treatment Teflon plastic infusion set can remain in Other types of infusion sets radiation must be removed ULTRASOUND e Pump infusion set and CGM Transmitter Sensor can remain on in Do Not bring pump into the same room where the procedure is being performed unless a lead apron that completely covers X RAY BODY pump is worn during the procedure The person administering FLUOROSCOPY the procedure if they are wearing a pump must proceed chest neck abdomen torso etc designated safety area during the procedure Teflon plastic infusion set can remain in Other types of infusion sets must be removed Do Not bring pump CGM Transmitter Sensor into the same room where the procedure is being performed unless a lead apron that completely covers pump and CGM Transmitter is worn during the X RAY BONE procedure The person administering the procedure if they are DENSITOMETRY wearing a pump or CGM Transmitter must proceed to a designated safety area during the procedure Teflon plastic infusion set can remain in Other types of infusion set
41. canceled Combo Bolus have been canceled Displayed once for 4 seconds Action Beeps Vib User selected one time No progression m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mM Alerts Warnings and Alarms Alert Low BG LOW BG No bolus Monitor BG action Press to confirm Beeps Vib User selected one time No progression NOTE The LOW BG Alert is different than the Low Glucose Alert that applies only to CGM readings Refer to Chapter 2 in Section pages 87 94 for information on CGM related alerts aqra Alert High HIGH BG BG entry above 13 9 mmol L Check site Check Effect Requires user confirmation to continue Ketanes Monitor BG Displayed until confirmed or until pump goes to sleep 88 Action Press to confirm Beeps Nib User selected one time No progression NOTE The HIGH BG alert is different than the High Glucose alert that applies only to CGM readings Refer to Chapter 2 in Section Il pages 87 94 for information on CGM related alerts m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Alerts Warnings and Alarms Alert Clear Program Basal Segments Clear command selected from BASAL OPTIONS screen effect Requires user confirmation to continue Clear Program deletes all basal segments in this program Clear Program Basal Options M Displayed until one of the two options is selecte
42. carries the Sensor Probe with it After inserting the Needle and Sensor Probe pull the Needle back into the Applicator Doing this leaves the Sensor Probe under your skin to continuously measure your glucose levels The Applicator with the Needle inside is pulled off from the Sensor Pod and should be thrown away Save the Safety Lock Transmitter Key because you can use it to remove the CGM Transmitter at the end of a CGM session The Sensor Probe lies underneath your skin at an angle and continuously measures your glucose levels for up to 7 days The Sensor Pod and CGM Transmitter once snapped in remain on your belly for the entire CGM Sensor wear period For information regarding possible CGM Sensor failures and errors refer to Chapter 10 in Section pages 127 140 WARNING CGM Sensors may fracture on rare occasions If a CGM Sensor breaks and portion of it is visible above the skin Do Not attempt to remove it Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at the injection site If you experience a broken CGM Sensor report this to Customer Support or your local Animas distributor see page 187 W99 m CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER mem CGM Transmitter Overview The CGM Transmitter wirelessly sends your glucose information from the CGM Sensor to the pump Once you insert the CGM Sensor you will snap the CGM Tran
43. cursor for Edit Mode 4 Use the buttons to change to desired setting 5 Press when setting is made m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Animas Vibe Insulin Pump L 6 To move to the next Ratio screen scroll to and press i 0 7 Scroll up to the Time field and press to change to flashing cursor for Edit Mode 8 Use the buttons to change the segment start time Press Q9 9 Scroll to the 1U grams field and press to change to flashing cursor for Edit mode 10 Use the buttons to change the 1U grams field as desired Press Repeat to set remaining segments per your health care team s recommendations To review your settings highlight and press to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press to return to the SETUP ADV 1 screen To return to the Home screen scroll to Home and press For more information see Chapter 10 in Section 1 pages 57 72 Setup Advanced Screen 1 Personal Settings Insulin Sensitivity Factor ISF An Insulin Sensitivity Factor ISF is the amount you can expect to lower your BG with one unit of insulin Your health care team may recommend you use different Insulin Sensitivity Factors ISFs for different times of the day When you use the ezCarb or ezBG feature your pump will automatically select the
44. details on how much insulin is required to fill the cannula Press Q9 Go is highlighted Press to fill the cannula NOTE The maximum Fill Cannula amount is 1U at a time Pum If your pump is suspended the screen will alert you with the ezPrime Pump Suspended suspended screen You must resume delivery of your pump in order to Priming complete the Priming function 15 disabled NOTE The Fill Cannula step is not required for your pump to operate For example when you prime your 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 unwanted delivery of insulin mw CHAPTER 3 GETTING YOUR PUMP READY Selecting the Infusion Site and Inserting the Infusion Set Your health care team will review appropriate site selections and techniques for insertion based on your body type Refer to the nstructions For Use included with your infusion set for proper insertion guidelines WARNING Do Not attempt to insert the infusion set into your body until you have been trained by your health care team Improper insertion of your infusion set can lead to death or serious injury Choose an area at least 7 6 centimeters 3 inches away from your CGM Sensor where you plan to inject insulin to insert the infusion set Avoid skin sites with tattoos or areas with rough patches or scarring from your pump or insulin inject
45. dialysis The safety and effectiveness of the CGM has not been evaluated for Sensor Probe insertion sites other than the abdomen Your Animas Vibe System will not automatically make insulin adjustments based on CGM readings You must take a fingerstick test with your blood glucose meter and use that blood glucose value to make any insulin or treatment decisions Insulin dosing decisions should not be based solely on results from the CGM mu BEFORE YOU BEGIN PRECAUTIONS Always wash hands with soap and water before opening the CGM Sensor package After opening the package avoid touching the adhesive area Before inserting the CGM Sensor always clean the skin at the insertion location with a topical antimicrobial solution such as isopropyl alcohol Do Not apply the CGM Sensor until the cleaned area is dry Establish a rotation schedule for choosing each new Sensor location Avoid locations that are constrained by clothing accessories or subjected to rigorous movement during exercise Avoid injecting insulin or placing an insulin pump infusion set within 7 6 centimeters 3 inches of a CGM Sensor The CGM Sensor is sterile in its unopened undamaged package Do Not use any CGM Sensor if its sterile package has been previously damaged or opened When entering fingerstick blood glucose values for CGM calibration you must enter the exact blood glucose value that your blood glucose meter displa
46. entered into your pump you are ready to begin a CGM session Each CGM session will last up to 7 days 166 hours after the 2 hour startup period after which you will need to replace the CGM Sensor and start a new CGM session During the 2 hour startup period your CGM will make adjustments so that it adapts to your body s biological environment NOTE Make sure you have removed the CGM Transmitter from its tray and have waited 10 minutes for it to be activated and ready for use 1 From the MAIN MENU screen scroll to CGM and press Suspnd Resum History Basal Setup Prime Rewind Status Home 2 Scroll to Start Stop and press BG Cal Trend Graph Start Stop NOTE If a session is currently active and Start Stop is selected you will go History to the CGM Stop Session screen Setup W99 Start CGM Scroll to START and press to begin the 2 hour startup period Wait at Start CGM least 8 seconds for the CGM session to start before pressing any other buttons sensor on the pump If you need to cancel the start of the CGM session scroll to SESS CANCEL and press to return to the CGM Menu screen START NOTE If you entered an invalid Transmitter ID Serial Number you will be prompted to re enter the correct Transmitter ID Serial Number nvali Transmitter ID 103 m CHAPTER 4 STARTING CGM SESSION mm 4 When you select Start a CGM Warning scr
47. have also changed your infusion site Setup 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 SETUP screen by selecting Setup from the MAIN MENU 1 From the Home screen 3 PM press to select Menu 0 07 Bolus Scroll to Setup on the CGM Time Date uspnd Resum MAIN MENU Press History anni Basal Rate Basal 2 Scroll to Time Date on 0 025U Hr Advanced the SETUP menu Press Insulin 105U Prime Rewind Status Status Home Press the button to activate Edit Mode indicated by flashing cursor m CHAPTER 3 GETTING YOUR PUMP READY Animas Vibe Insulin Pump 4 Use the O O buttons to change to your desired settings Press the SETUP button to confirm your setting and exit Edit mode Time Date Hour Minute 5 Use the buttons to select the next field Repeat the above process aa li EUM Scroll to highlight Main Menu and press button when finished Mon Jan r MAIN MENU screen will be displayed Day 29 Year 2010 NOTE e t is important to have the correct current date and time set in your pump Be sure to confirm the date and time before saving them in your pump f you 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 tim
48. horizontal lines on the graphs included in the CGM Trend screens These levels will also affect the color coding of the Trend Arrows that appear in the CGM Data and CGM Trend screens If you choose to disable these alerts the horizontal lines will not appear on the Trend graph and the alerts will not display sound on the pump See Chapter 6 in Section Il pages 109 118 for more information on the CGM Data and CGM Trend screens Rise and Fall Rate Alerts The Rise and Fall Rate Alerts will display sound on your pump if your CGM readings begin to rise or fall at or faster than these limits CGM Setup Sounds 1 From the CGM Setup screen scroll to Rise Rate Press Q9 High Alert Low Alert Rise Rate Fall Rate Out of Range Transmitter CGM Menu 2 With the Rise Rate field highlighted on the Rise Rate screen press to SE mmol L min activate the edit mode flashing highlight Use the buttons to select the desired value for the Rise Rate Alert and press Q9 to return to the CGM Setup screen You may set the Rise Rate limit at either 0 11 mmol L per minute or the default rate limit of 0 17 mmol L per minute Enable Yes CGM Setup Fall Rate b 3 Scroll to Fall Rate on the CGM Setup screen and repeat these steps for mmol L min the Fall Rate Alert When you are finished scroll to CGM Setup and press to return to the CGM Setup screen You may set the Fall Rate limit at either Enable 0
49. in pump not user selected Displayed each time pump is awakened until confirmed Action Press to confirm Check BG with fingerstick test Beeps Vib Every 3 minutes until confirmed If confirmed snooze for 30 minutes No progression Message Alert CGM Session Stopped By User Cause User stopped current CGM session CGM Session Stopped T by User Insulin deliveries continue CGM session ends Dexcom CGM Displayed once for 4 seconds Beeps Vib User selected under CGM Setup menu options one time No progression 138 m CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS mum Alert CGM Session Active Transmitter ID Serial Number number cannot be CGM Session entered if CGM session is active Active Beeps Vib User selected under CGM Setup menu options one time No progression Alert CGM Session Not Active You are trying to enter a BG value into the pump CGM Session but no CGM session is active Not Active effect Insulin deliveries continue No CGM Displayed once for 4 seconds Action Start new CGM session if desired Beeps Vib User selected under CGM Setup menu options one time No progression NSO 139 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Alert CGM Data Not Available While Pump Suspended Pump C CGM menu options not available on pump while it is Suspended ause suspended Must Resume pump to vi
50. in under infusion Occasionally check the infusion set tubing for any damage leaks or kinks while using your 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 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 Failure to follow these guidelines may pose health hazards Prior to replacing the battery cap make sure the o ring fits securely and is not damaged A damaged o ring may impact the battery contact and or the waterproof feature of your pump See Chapter 3 in Section 1 pages 9 20 Prior to inserting a cartridge into your pump check the o rings on the cartridge to be sure they are not damaged Damaged cartridge o rings can result in under or over delivery of insulin Occasionally check the vents to be sure they are clear of debris See Chapter 1 in Section pages 141 144 Occasionally check that your pump personal settings are correct Occasionally check to make sure your pump emits audible tones that are easily detectable and that the vibrate feature is working correctly For example audible tones should be heard and the vibration pulse felt every time you
51. limited warranty does not extend to any damage resulting from the following changes or modifications to the pump by the user or any other third person after the date of manufacture service or repairs performed by any person or entity other than an Animas authorized service person a force majeure or other event beyond the control of Animas 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 Vibe Insulin Pump or 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 fitness 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 c
52. may set off the metal detector at airport security check in Additionally airport security systems such as X rays may damage the pump so it may be necessary to disconnect and remove the pump prior to going through security Contact your local airport administration or security office before traveling by air to obtain information about bringing your pump through airport security check in Delays through customs may occur if you have a pump malfunction and need a pump replacement Call Customer Support or your local Animas distributor for information about obtaining a pump replacement 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 see page 187 Adjust your pump s clock when crossing time zones For more information on traveling with pumps visit the American Diabetes Association ADA website www diabetes org or call your local airport for security guidelines that may apply Intimacy Your pump need not interfere with intimacy You can disconnect most infusion sets Always follow your health care 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 BG levels 160 This chapter provides tables to record information needed for programming your personal settings into your pump Consult your health care te
53. not function properly You can also change the battery type on the VERIFY screen when you insert a new battery 1 From the SETUP ADV 4 screen scroll to the desired field 2 Press to change to flashing cursor for Edit mode 3 Use the buttons to change to desired setting 4 Press when setting is made To move the next Setup Advanced screen scroll to the bottom of the screen and highlight gt Press To return to the Home screen scroll to Home and press CONTRAST BUTTON CGM SHORTCUT 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 button on top of your 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 f in Call Service Alarm mode you must use the button to restore the default contrast level To return contrast setting to original factory default press the button and button at the same time When the word Contrast is displayed on the screen press any button to return to the default contrast setting NOTE When viewing your pump display in bright sunlight it is recommended you shade the screen or m
54. problems and causes of high BG are listed in the following table as are some suggested solutions DKA Diabetic Ketoacidosis Hyperglycemia can lead to DKA If your BG is above 13 9 mmol L check blood or urine ketones per your health care 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 149 uoneunoJu je2Iuuoo e ueuojurew D m CHAPTER 3 TROUBLESHOOTING GUIDELINES sm Troubleshooting hyperglycemia INFUSION SET POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Redness irritation inflammation swelling discharge or discomfort Change infusion set tubing and site Contact health care team Change infusion set and rotate sites Buin porno gute gEIRTHSION SM Avoid this area for site selection Scar tissue Avoid this area for site selection Catheter inserted in area of friction Avoid waistline and friction areas Kink in tubing catheter Change infusion set tubing and site Infusion set not primed air in tubing Disconnect tubing from body Prime tubing completely Verify filling volume from manufacturer s instructions Cannula not filled and program that amount when prompted on the FILL CANULLA screen as needed Tubing not tightly attached to cartridge Tighten tubing attachment to cartridge
55. programming and may not be representative of current health states e The Animas Vibe Insulin Pump uses a color display screen but display screens throughout the Owner s Booklet are always shown in black and white e Blood Glucose is often abbreviated as BG in both instructional copy as well as in example display screens e Continuous Glucose Monitoring is often abbreviated as CGM in both instructional copy as well as in example display screens e Your Animas Vibe System consists of an Animas Vibe Insulin Pump a Dexcom G4 Transmitter Dexmitter and a Dexcom G4 Sensor Dexsensor Your Animas Vibe Insulin Pump will often be referred to as simply your pump Your Dexcom G4 Transmitter will often be referred to as your Transmitter Your Dexcom G4 Sensor will often be referred to as your Sensor Together your Dexcom G4 Transmitter and Sensor will often be referred to as your Dexcom CGM or your CGM Take special note of Warnings Cautions Precautions and Safety Information throughout this Owner s Booklet which are identified with A Intended Use The Animas Vibe Insulin Pump and Dexcom CGM System Animas Vibe System is indicated for continuous subcutaneous infusion of insulin for the management of insulin requiring diabetes The Animas Vibe System is also a glucose monitoring device indicated for detecting trends and tracking patterns in adults age 18 and olde
56. screen O Prime Continue with Step 8 O Fill Cannula d que You can only highlight Load Cart from the ezPrime menu after the rewind action is complete This is true for all ezPrime menu options you can only proceed to the next action once the previous action is aqra GB complete 8 On the REWIND COMPLETE screen Continue COMPLETE CARTRIDGE is highlighted Press Your pump will align the Disconnect set ACTIVE Load U100 piston rod with the cartridge The LOAD CARTRIDGE cartridge Please wait ACTIVE screen is displayed followed by the PRIME Attach cap screen Your pump will beep once to let you know Continue the cartridge is aligned with the piston rod gt Be sure set 15 9 On the PRIME screen Continue is highlighted Press disconnected DELIVER PRIME from your body Press AND HOLD Insulin 200U OK button while priming Continue 10 The DELIVER PRIME screen is displayed Be sure the infusion set is not Insulin 200U connected to your body until the prime is complete GaGa A WARNING Never prime while the infusion set is connected to your body Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin and possible injury or death If your pump sustains internal damage the amount of unintended insulin delivery could be significant This cou
57. site for infusion set insertion A CAUTION Under no circumstances should you use an alcohol wipe or skin prep to clean your pump See Chapter 1 in Section pages 141 144 Battery Type Your pump is designed to achieve optimum performance and battery longevity with an Energizer Lithium Ultimate AA battery 1 5V Check to be sure you have the correct lithium battery type before inserting the battery A CAUTION It is possible to safely power your 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 the Low and Replace Battery Warnings If you must use an AA alkaline battery the following is recommended Energizer EA91 WARNING Rechargeable batteries and Carbon Zinc batteries do not have the necessary characteristics to power your pump and must not be used Use of these batteries voids your pump warranty Under no circumstances should you attempt to power your pump with a high energy 3 6V AA Lithium battery Use of these batteries could permanently damage your pump and voids its warranty NOTE Your pump uses battery power to notify you of 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 Ba
58. suspect your pump has been damaged 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 see page 187 They will help determine if your pump should be replaced You can also obtain information at www Animas com Your pump is designed to operate in conditions where temperatures are between 5 C 40 and 40 C 104 F If your pump is exposed to temperatures outside these parameters extra care should be taken to protect it from extreme temperatures To avoid risk of explosion Do Not use your pump in the presence of explosive gases Your pump is designed to achieve optimum performance and battery life with an Energizer Lithium Ultimate AA battery 1 5V Rechargeable batteries and Carbon Zinc batteries do not have the necessary characteristics to power your 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 your pump and voids its warranty Do Not use household cleaners chemicals solvents bleach scouring pads or sharp instruments to clean your 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 vin mw BEFORE YOU BEGIN A CONTRAINDICATIONS
59. 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 your 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 Customer Support or your local Animas distributor 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 see page 187 Your CGM components are tested at IPX8 resistance to jetting water and continuous submersion of Sensor and Transmitter for 24 hours at a depth of 2 4 meters 8 feet NOTE CGM readings may not be transmitted from your CGM to the pump while in water High Altitude Activities Skiing Hiking etc Your pump is tested at altitudes up to 3048 meters 10 000 feet at standard operating temperatures Extreme altitude temperature or atmospheric conditions may affect pump performance Refer to page 167 for more information on operating conditions Your CGM components and possibly your BG meter have not been tested in extreme altitudes Refer to pages 174 175 for more information on operating conditions Traveling With a pump traveling becomes less complicated and more enjoyable However traveling still requires preparation Remember to order your pump supplies in advance and pack the fo
60. the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Animas Vibe System is used exceeds the applicable RF compliance level above the Animas Vibe System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as IEC 60601 Test Level 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz Compliance Level Not applicable re orienting or relocating the Animas Vibe System b Over the frequency range 150 kHz to 80MHz field strengths should be less than 3 V m 171 Electromagnetic Environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Animas Vibe Insulin Pump including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 0 35VP 80 MHz to 800 MHz d 0 7VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equ
61. the performance of the CGM When using your BG meter to obtain CGM calibration values e Always use a fingerstick test Do Not use alternative sampling sites e g palm or forearm e Always use the same BG meter for calibration for each CGM session Do Not switch your BG meter in the middle of a CGM session Follow your BG meter instructions for BG testing e t is important to follow proper BG testing techniques to ensure accurate calibration values and CGM performance 105 mw CHAPTER 5 CGM CALIBRATION Dexcom CGM 2 Hour CGM Startup Period Calibration When the 2 hour CGM startup period ends you will be prompted to enter 2 separate fingerstick BG values in your pump Press to confirm the Warning Enter 2 Startup BGs Confirm ENIM 1 Scroll to Cal on the CGM Menu screen and press Trend Graph Start Stop History Setup 2 The value field will be highlighted and flashing on the BG Calibrate screen Use the O buttons to enter the first of 2 fingerstick BG values Press CANCEL will be highlighted Scroll to CALIBRATE and press Q9 If you need to cancel the BG value scroll to CANCEL and press In either mmo case you will return to the CGM Menu screen CALIBRATE NOTE The value on the BG Calibrate screen will start at 6 7 mmol L the first CANCEL time you calibrate and at the current CGM reading when in calibration 3 Repeat step 2 to enter the
62. 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 Animas Vibe Insulin 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 hormone produced by the beta cells in the pancreas Insulin is needed by the body to regulate the production and use of glucose 179 mw APPENDIX A GLOSSARY insulin limits Insulin limits are a programmable feature of the Animas Vibe Insulin Pump After consulting with your health care team you can use the Advanced Setup menu to program maximum limits for basal rate delivery bolus delivery 2 hour and total daily delivery insulin on board IOB Refers to how much insulin remains in your body from a previous bolus Knowing how much insulin remains allows you to adjust your next bolus amount accordingly to avoid delivering too much insulin You can use the IOB feature on your pump to account for any remaining ins
63. with a blood glucose meter before making therapeutic adjustments W99 uo xea 111 You should update the CGM s calibration every 12 hours at a minimum The performance of the CGM when calibrated less frequently than every 12 hours has not been studied A CAUTION While insulin delivery is suspended your CGM session will remain active but CGM readings will not be recorded or displayed As soon as insulin delivery resumes CGM readings will start recording and displaying again 109 m CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mem Dexcom CGM CGM Data Screen The CGM Data screen provides a snapshot of your current glucose status Each CGM Data screen displays the current time on your pump your current CGM reading any Insulin on Board IOB and Trend Arrows that represent how fast your glucose levels may be rising or falling See the charts that follow on pages 111 112 for the meaning of the various symbols that might appear on the CGM Data screen CGM Trend Screen The CGM Trend screen provides a more detailed view of your glucose status and includes a graphical display of your CGM readings over a time period you select 1 3 6 12 or 24 hours Each CGM Trend screen also includes the current time on your pump your most recent CGM reading High Glucose and Low Glucose Alert settings and Trend Arrows that represent how fast your glucose levels may be rising or falling See the charts that f
64. with using your pump for insulin delivery before you begin using the continuous glucose monitoring CGM features on your pump See the appropriate chapters in Section 1 pages 1 84 for the steps on setting up and using your insulin pump The following insulins have been tested by Animas and found to be safe for use in the insulin cartridge of the pump Humalog Novo Rapid NovoLog and Apidra Before using a different insulin with this pump check the insulin drug label and your health care status to make sure it can be used with your pump Insulin pump therapy is recommended for people with diabetes who are willing to e Test their blood glucose levels four to six times per day or as recommended by their health care team e Demonstrate adequate carbohydrate counting skills e Maintain good diabetes self care skills e See their health care professional regularly and Have adequate vision and hearing to respond to pump alerts warnings and alarms You should carefully read this Owner s Booklet and any inserts that come with your Animas Vibe System These include an insert for Animas Vibe System Quick Reference Guide Dexcom CGM Quick Start Guide Dexcom CGM Transmitter Dexcom CGM Sensor mw BEFORE YOU BEGIN While reading this Owner s Booklet please note the following Display screens throughout the Owner s Booklet are examples only They should not be considered suggestions for individual
65. 11 mmol L per minute or the default rate limit of 0 17 mmol L per minute Yes NOTE You can enable or disable default is Yes enable the Rise and Fall Rate Alerts If this feature is disabled the Rise and Fall Rate Alerts will not display sound on the pump 92 m CHAPTER 2 CGM SETTINGS Transmitter Out Of Range Alert The Transmitter Out of Range Alert will display sound on your pump if your CGM Transmitter is not within RF range of your pump 3 6 meters 12 feet CGM Setup 1 From the CGM Setup screen scroll to Out of Range Press Q9 Sounds High Alert Low Alert Rise Rate Fall Rate Out of Range Transmitter CGM Menu 2 With the Snooze Time field highlighted on the Out of Range screen press Q to activate the edit mode flashing highlight Use the buttons enna to select the desired snooze time for the alert and press The snooze time lets you set a time for the Out of Range alert to display sound again on your Enable pump after you first confirm the alert if the condition causing the original Yes alert has not been resolved You may set a snooze time from 21 to 201 minutes default value is 30 minutes in 3 minute increments When you are finished scroll to CGM Setup and press to return to the CGM Setup screen NSO NOTE You can enable or disable default is 5 enable the Out Of Range Alert If this feature is disabled the Out Of Ra
66. 250 61048 Email infodiabete movigroup com Web www movimed it Norway Rubin Medical AB Krossverksgatan 5M Box 30044 20061 LIMHAMN Sweden Tel 46 4015 5480 Fax 46 4015 5825 Email info rubinmedical se Web www rubinmedical se 187 ANIMAS DISTRIBUTOR CONTACT INFORMATION Spain NOVALAB IB RICA S A L c Argentina 2 P A E Casarrubios Nave A 10 28806 Alcala de Henares Madrid Spain Tel 34 918 024 515 Toll free 34 902 117 362 Tech support 34 661 854 628 Fax 34 918 026 577 Email info novalab es Web www bomba insulina com Web www novalab es Sweden Rubin Medical AB Krossverksgatan 5M Box 30044 20061 LIMHAMN Sweden Tel 46 4015 5480 Fax 46 4015 5825 Email info rubinmedical se Web www rubinmedical se United Kingdom amp Ireland Animas UK amp Ireland 50 100 Holmer s Farm Way High Wycombe Buckinghamshire HP12 4DP United Kingdom Supplies amp Tech support 44 800 055 6606 Email lsukdc lfsgb jnj com Web www animascorp co uk 188 Animas ORPORATIOQ 200 Lawrence Drive West Chester PA 19380 USA Customer Support is available 24 hours a day 7 days a week United Kingdom Call free phone 0800 055 6606 Ireland Call 1 800 812 715 All other countries call your local Animas distributor Consult Owner s Booklet CE ow MediMark Europe Sarl 11 rue Emile Zola BP 2332 38033 Grenoble Cedex 2 France
67. 3 84 Edit Basal BASAL OPTIONS A1 WEEKDAY 10 Review is highlighted Press to review your entries for accuracy Total 13 60U Your basal segment settings are shown 5 on first screen 5 on second screen clear and 2 on last screen If you have more than 5 segments programmed scroll to Next to see second and third screens as desired 11 Options is highlighted Press The BASAL OPTIONS screen is displayed a If you have edited and saved reviewed the active program it is resumed automatically You can also select Go and the Home screen is displayed A1 WEEKDAY which shows the current rate of delivery for the program that is active Total 13 60U Clear b If you have 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 rate of delivery for the program that is active Adding Changing Segments in an Existing Basal Program 1 From the BASAL MENU select desired program 2 Edit is highlighted Press 3 Scroll to highlight the field you wish to change or to next available blank line to add a segment Press to activate Edit mode The cursor will flash to indicate Edit mode 4 Use O O buttons to set Start times and U Hr amounts 5 Check that the AM PM settings are correct mw CHAPTER 5 USING BASAL PROGRAM
68. 5 minutes No progression if Beeps Vib confirmed each time displayed Sweep vib within one hour if not confirmed Warning No Cartridge Detected Deliveries Disabled No cartridge No cartridge detected after Load cartridge step during detected Prime Rewind Delivery disabled LETT Press Q9 to confirm Be sure Prime Rewind sequence is completed with cartridge properly in place User selected once every 3 minutes No progression if Beeps Vib confirmed each time displayed Sweep vib within one hour if not confirmed 7 m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Animas Vibe Insulin Pump 1 Alerts Warnings and Alarms Warning Low Battery Warning i Battery life will last a minimum of 30 minutes battery Effect Insulin deliveries continue Displays when pump is awake until confirmed TI Message Displays when triggered by event such as bolus amp when manually awakened Acion Press to confirm Insert new Battery i i 1 If Beeps Vib User selected every 3 minutes until confirmed not confirmed progresses to sweep vib within one hour Warning Low Cartridge 2 Low Cause Low insulin level reached cartridge XX U or Insulin deliveries may continue until Empty Cartridge less left alarm is triggered Confirm Displayed when manually awakened until confirmed Action Press to confirm
69. 55 6606 In Ireland call 1 800 812 715 All other countries call your local Animas distributor see page 187 126 10 m CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Your pump DOES NOT have the same progressive warnings and alarms safety system for CGM functions as it does for insulin delivery functions Refer to Chapter 11 in Section 1 pages 73 84 for more information on the progressive warnings and alarms safety system for pump alarms not related to CGM functions This chapter reviews the warnings and alerts that appear and sound on your pump regarding CGM functions See Chapter 11 in Section 1 pages 73 84 for information on warnings alarms and alerts associated with insulin delivery on your pump If multiple CGM alerts warnings or alarms occur simultaneously the pump will display the most critical one first After confirming the condition with the highest priority the one currently displayed the alert alarm or warning with the next highest priority will be displayed until confirmed Each alert alarm and or warning must be confirmed separately until all simultaneous conditions have been confirmed The CGM warnings and alerts that are described in this chapter apply only to the CGM part of your Animas Vibe System They do not apply to any other CGM system Warning 2 BG Values Required For 2 Hour Startup Calibration Cauze No BG values have been entered in the pump Enter 2 following the 2 hour CGM startup session
70. 715 5 2011 01 n A S N XX XXXXX 16 T ce Sounds Your pump allows you to customize the volume level or use the vibrate function to notify you of warnings and alarms and to confirm certain insulin deliveries In addition you have the option to set CGM related alarms and alerts in the CGM setup Menu see Chapter 2 in Section pages 87 94 m CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP mm Animas Vibe Insulin Pump Resistant Locked Feature You can use the tamper resistant feature to prevent accidental button pressing Simply wake up your pump and press and hold the and buttons at the same time until the screen reads LOCKED Press amp hold both arrow buttons to unlock This locks your pump buttons To unlock your pump wake up your pump so the screen reads LOCKED Press 8 hold both arrow buttons to unlock and press and hold the and buttons at the same time until the screen display wakes up Basic Display Screens Verify Screen Mode 12Hr Month Jan When you insert a battery this is the first screen you see after the hourglass Day 7 appears on the display From here you should verify the settings for time Year 2010 H 1 1 ENGLISH date language and battery type With Confirm highlighted press to Battery Lith confirm the settings and go to the Home screen NOTE f you were in the middle of a CGM session when you inserted a b
71. Animas e Nibe Insulin Pump amp CGM System i N xs 4 NN ES 1 4 2 y No SERM s DOS SEE Ls 5203 red CX Wigs i DECOM 4 ConTihuols GLUCOSE gt EN v d AN t A X M Lm 3747 nS Y k 5 X Welcome and Congratulations Thanks for choosing the Animas Vibe System Your Animas Vibe System can play an integral part in the blood glucose management and continuous insulin delivery regimen that you have established with your health care professional Your Animas Vibe System provides both continuous insulin delivery and continuous glucose monitoring CGM when used in conjunction with Dexcom CGM components Your Animas Vibe Insulin Pump provides continuous insulin delivery to help you maintain your blood glucose targets as recommended by your health care professional It delivers insulin in two ways 1 continuous basal insulin delivery and 2 bolus insulin delivery to cover foods eaten and or reduce a high blood glucose level This Owner s Booklet will provide you with a thorough understanding of your Animas Vibe System and how to get the most from it The Owner s Booklet is designed to provide the information you are looking for when you need it and is organized in an easy to find style that places the information at your fingertips Additional copies
72. B amount is displayed for reference and is applied to the suggested total bolus amount GB In Examples 2 and 3 the IOB amount is displayed for reference but is not applied to the suggested total bolus amount In both cases even though your current BG level is above the target range there is sufficient IOB to cover the high BG Therefore no insulin amount is suggested to cover the high BG mew CHAPTER 10 USING ADVANCED FEATURES m Animas Vibe Insulin Pump L Combo Bolus The Combo Bolus feature is used to split your bolus into a Normal and Extended Bolus This feature is useful for consumption of high carb high fat meals such as pizza that have prolonged carb absorption It is also useful if you will be eating grazing over a few hours or if you have gastroparesis where food remains in the stomach for a longer period than normal You can program part of your bolus amount to be delivered immediately Normal portion and part of it to be delivered slowly over the course of up to 12 hours Extended portion Your health care team can help you determine the split of Normal to Extended insulin amounts as well as the duration that is most appropriate for you BOLUS MENU 1 From the BOLUS MENU select Combo Bolus If you used the ezCarb Bolus option to calculate a bolus and chose to deliver it as a Combo Bolus Combo Bolus you will begin at the Combo Bolus
73. CGM Sensor and Transmitter must be removed prior to Magnetic Resonance Imaging MRI Use of acetaminophen containing medications while the CGM Sensor is inserted may affect the performance of the CGM WARNINGS The CGM is not designed to replace a blood glucose meter The CGM must be used with a blood glucose meter e Treatment decisions should not be based solely on results from the CGM You must confirm with a blood glucose meter before making therapeutic adjustments Symptoms related to low or high blood glucose levels should not be ignored If you have symptoms of low or high glucose use your blood glucose meter to check the CGM results You should update the CGM s calibration every 12 hours at a minimum The performance of the CGM when calibrated less frequently than every 12 hours has not been studied CGM Sensors may fracture on rare occasions If a CGM Sensor breaks and no portion of it is visible above the skin Do Not attempt to remove it Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at the injection site If you experience a broken CGM Sensor report this to Customer Support or your local Animas distributor 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 see page 187 CGM is Not Approved For Use in children or adolescents pregnant women or persons on
74. CGM session will continue Press to continue but be prepared to treat High or Low BG according to your health care professional s recommendations An additional CGM Alarm will display sound on your pump when your most recent CGM reading is at or below 3 1 mmol L This Alarm limit is fixed and cannot be changed or disabled You will be re alerted every 30 minutes if your Glucose current CGM reading remains at or below 3 1 mmol L Level is Below Refer to Chapter 10 in Section II pages 127 140 for additional information 3 1 mmol L about CGM alerts that display sound on your pump Confirm 2 114 mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mem Missing CGM Readings Periodically you may notice you are missing CGM readings on the CGM Data and CGM Trend screens Missing means one or more CGM readings have not been received or were not understood by your pump and are not available for display You can identify missing data by a symbol appearing instead of your most recent CGM reading and trend arrow s or that there are gaps no data when displaying CGM Trend graphs This can happen when e Your pump and CGM Sensor Transmitter not communicating Your pump does not recognize the CGM Sensor Transmitter signal e Your pump is waiting for you to enter a fingerstick BG value to recalibrate the CGM The reading cannot be displayed WARNING The CGM is not designed to replace a blood glu
75. CGM values limits for e High Alert Low Alert Rise Rate Fall Rate You can also set a snooze time for the High and Low Alert limits and the Transmitter Out of Range alert See the pages that follow for more information on CGM Alerts NOTE f you disable an Alert it will not display sound on the pump You cannot disable the CGM Warning that displays sounds when your most recent CGM reading is at or below 3 1 mmol L m CHAPTER 2 CGM SETTINGS High and Low Glucose Alerts The High and Low Glucose Alerts will display sound on your pump if the last CGM reading is at the limit or falls above or below these limits CGM Setup 1 From the CGM Setup screen scroll to High Alert Press High Alert Low Alert Rise Rate Fall Rate Out of Range Transmitter CGM Menu 2 With the Warn above field highlighted on the High Alert screen Warn above press so that the highlight is flashing Use the O O buttons to select sn Ammo the desired level for the High Alert and press You may set the High Alert 0 minutes from 6 7 mmol Lto 22 2 mmol L default is 11 1 mmol L in 1 1 mmol L Enable increments Yes CGM Setup a The Snooze Time field will be highlighted Use the Q buttons to NSO Warn above select the desired snooze time for the High Alert and press The snooze 1 time lets you set a time for the High Alert to display sound again on your
76. CLUDING 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 ANIMAS VIBE INSULIN PUMP MAINTENANCE PARTS WARRANTY Limited Product Warranty for Insulin Pump Maintenance Parts Battery Caps Cartridge Caps etc Your Animas Vibe 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 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 EXPRE
77. Check After Bolus When this feature is turned on your pump will display the BG Reminder Reminder screen immediately after a bolus On this screen you can use the Q buttons to select a different reminder time 1 2 3 or 4 hours or choose not to be reminded by entering For example if you have given a bolus in the evening you may not wish to have the Reminder sound while you are sleeping If the Reminder is not confirmed battery life will be reduced and the Replace Battery Alarm will appear sooner than expected Check BG NOTE The BG Reminder screen is not displayed when you use the Audio Bolus feature mew CHAPTER 10 USING ADVANCED FEATURES mm NOTE When you enter a time your pump will sound a reminder and display this screen at that time after any Normal Bolus or Audio Bolus is delivered including the Normal portion of a Combo Bolus If you program an Extended Bolus only the reminder will sound at the default time you have set 3 When finished setting reminders scroll to Menu and press to display the MAIN MENU 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
78. DED 3 The Home screen is then displayed showing that pump deliveries are Basal Rate suspended 0 675U Hr Insulin 105U Status GB m CHAPTER 6 SUSPEND RESUME FEATURE mm CAUTION While insulin delivery is suspended your CGM session will remain active but CGM readings will not be recorded or displayed As soon as insulin delivery resumes CGM readings will start recording and displaying again If you want to temporarily suspend insulin delivery but still view CGM readings do not use the suspend delivery feature Instead you can program a temporary basal of 0 units for the time period you want basal delivery suspended and still be able to view CGM readings NOTE If you suspend insulin delivery during the 2 hour CGM Calibration Startup period the calibration sequence will continue and the CGM session will No delivery remain active even though insulin delivery is suspended e See Section pages 85 140 for information on CGM functions suspended Periodically your pump will beep or vibrate if that is the setting you selected to remind you of the Suspend status If confirmed the beeps will progress to high volume in one hour You can confirm the Warning to reset the audible sequence See Chapter 11 in Section 1 pages 73 84 Animas Vibe Insulin Pump Resuming Delivery Suspnd Resum History 1 From the MAIN MENU scroll dow
79. ED FEATURES SETUP AND ACTIVATION NOTE e The Low Cartridge Warning only alerts you one time For example if you have it set to 30U and receive an alert and then change the setting to 20 it will Low cartridge 10U or less left not alert at 20U until after the next cartridge has been primed f a bolus is delivered which causes a Low Cartridge Warning your remaining insulin may be less than the Warning screen displays Confirm i SETUP ADV 7 Setup Advanced Screen 7 Audio Bolus Feature You can set your pump to bolus without having to look at the screen display by pressing the black button on the right side of your pump boluses delivered with the Audio Bolus feature will be delivered as Normal Boluses This screen allows you to Animas Vibe Insulin Pump e Turn the Audio Bolus feature on or off Select the Audio Bolus delivery step size 0 1 0 5 1 0 5 0 Units 1 From the SETUP ADV 7 screen scroll to the desired field 2 Press to change to flashing cursor for Edit mode Use the 6 6 buttons to change to desired setting Press when setting is made NOTE If Audio Bolus is activated you cannot use the side button as a shortcut to Normal Bolus 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 gt Press To return to the Home screen scroll to H
80. GM rise and fall rate of change alerts Alerts based on how fast your CGM readings rise fall CGM safety lock transmitter key The Safety Lock keeps the Needle inside the Applicator before you are ready to insert It also helps you snap the Transmitter out of the Sensor Pod after your CGM session has ended CGM sensor applicator disposable piece that comes attached to the Sensor Pod and inserts the Sensor Probe under the skin There is a Needle inside the Applicator that you remove once you have inserted the Sensor Probe CGM sensor pod The small base of the Sensor attached to your belly that holds the Transmitter and Sensor Probe in place The Sensor Pod and Transmitter are all that remain on your skin during each CGM Sensor use CGM sensor probe The part of the Sensor that is inserted under your skin with the Applicator It measures the glucose levels in your surrounding tissue fluid CGM startup period The 2 hour startup period after you tell the pump you have inserted a new Sensor CGM readings cannot be provided during this time 177 CGM components The Sensor Transmitter and other components used to insert remove the Sensor CGM transmitter The CGM component that snaps into the Sensor Pod and wirelessly sends CGM readings to your pump CGM transmitter ID Transmitter ID Serial Number that is entered into your pump to talk to the Transmitter CGM transmitter latch The small disposable piece t
81. ID Serial Number see Chapter 2 in Section pages 87 94 Revs P XXX Software versions D XXX L X X W XXX G XX XX XX XX To move to the next STATUS screen press with gt highlighted at the bottom of the screen To return to the Home screen highlight Home and press Status Screen 7 Additional Pump Codes The screen contains information that will be useful to Customer Support or your local Animas distributor see page 187 if requested STATUS 7 CODES XX XX XX 2 XXX XX XX XX Y XX XX XX XX ZXX XX XX XX To move to the next STATUS screen press with gt highlighted at the bottom of the screen To return to the Home screen highlight Home and press me CHAPTER 8 STATUS FEATURE mm Animas Vibe Insulin Pump LES ms CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Now you have made it through the basics Your pump offers many advanced features that you may find helpful in managing your diabetes Consult with your health care team to determine which advanced features and settings are appropriate for you WARNING Be sure to discuss which advanced features and settings are right for you with your health care team Many of the advanced features settings require input from your health care team before you begin using the feature Use of incorrect settings on certain advanced features
82. ISF for the current time stored in the pump This screen allows you to set different ISFs for 12 different time slots NOTE If you set only one Insulin Sensitivity Factor it will be used for the entire 24 hour period 1 From the SETUP ADV 1 screen scroll up ISF Press Q9 Ratio BG Target 2 The first segment always starts at midnight The last time slot available is 11 30pm Use the buttons to scroll to the 1U mmol L field Press to change to flashing cursor for Edit mode 4 Use the buttons to change to desired setting 5 Press when setting is made 6 To move to the next ISF screen scroll to and press m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION 7 Scroll up to the Time field and press to change to flashing cursor for Edit mode 8 Use the buttons to change the segment start time Press Q9 9 Scroll to the 1U mmol L units field and press to change to flashing cursor for Edit Mode 10 Use the O O buttons to change the 1U mmol L units field as desired Press Repeat to set remaining segments per your health care team s recommendations To review your settings highlight and press to scroll through each segment Confirm the times and setting values are correct When finished scroll to Done and press to return to the SETUP ADV 1 screen To return to the Home screen scroll to Home an
83. LOSSARY type 1 diabetes Type 1 diabetes results from destruction of the beta cells in the pancreas People with type 1 diabetes mellitus must use insulin to regulate their BG levels type 2 diabetes Type 2 diabetes usually occurs in people 40 years or older People with type 2 diabetes have a progressive loss of beta cells over time They can sometimes regulate their BG levels by following an individual meal plan exercising and taking antidiabetic pills They frequently require insulin for optimal BG control 181 m APPENDIX A GLOSSARY 182 Active basal program empty alert 27 74 Advanced 21 48 59 Advanced features 43 piu V Air bubbles VIII 152 eet ER VII 160 Alarms 114 127 Alarms insulin 12 73 Alarm history insulin delivery 35 Alert history CGM 121 Alerte CGM 89 127 Alerts insulin delivery 12 73 EE RETE 159 Amusement VII Arrows on 5 5 110 111 Attaching the CGM 5 100 Audio
84. MP ACTIVE 0 675 U Hr 40 0 405 U Hr Time left 1 2 Hr CANCEL Pump Suspended If active Temp Basal amp Combo Bolus have been canceled A CAUTION When you switch to another basal program or set a Temp Basal you will most likely be changing the total insulin units delivered over a period of time Be sure to review the total insulin units before you switch basal programs or set a Temp Basal Units that are too high or too low may result a hypoglycemic or hyperglycaemic event m CHAPTER 5 USING BASAL PROGRAM FEATURES Animas Vibe Insulin Pump LES CHAPTER 6 SUSPEND RESUME FEATURE sm This feature allows you to stop and restart 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 in Chapter 9 in Section pages 43 56 Suspending Delivery 1 From the MAIN MENU scroll to Suspnd Resum and press Suspnd Resum History Basal Setup Prime Rewind Status Delivery 2 Suspend is highlighted Press Pump Suspended The screen will display a message reminding you that this mode not only If active suspends your active basal delivery but also cancels any Temp Basal or Temp Basal amp Combo Bolus that may be active Combo Bolus have been canceled 2 2 7 EN SUSPEN
85. NORMAL BOLUS Amount Go is highlighted Press to deliver the bolus 2 351 DELIVERING U 4 The DELIVERING bolus screen is displayed If you have activated the 2 00 Normal Bolus sound in the SETUP SOUND menu your pump will to Press any confirm start of delivery as well as when delivery is complete function button to cancel NOTE During a bolus delivery you can stop delivery at any time by pressing Poss any button on the front panel of your pump The Warning screen shown here will be displayed Confirm the Warning by pressing and check your Bolus user button press Delivered 1 35U of 2 35U History for the amount delivered NOTE You can check when you last gave a bolus by looking in History or Status These features are covered later See Chapter 7 pages 33 38 and Chapter 8 pages 39 42 in Section 1 mw CHAPTER 4 USING THE NORMAL BOLUS FEATURE NOTE If you have Advanced Bolus and Reminders features turned on the BOLUS MENU BOLUS MENU shown on the right will be displayed when you select Bolus from the MAIN MENU Select Normal and press Follow steps 2 through 4 ERES in this chapter EA Combo Bolus Reminders Animas Vibe Insulin Pump ms CHAPTER 5 USING BASAL PROGRAM FEATURES You can program your pump to display either 1 or 4 basal program options Basal insulin is delivered continuously to help keep your BG in target between meal
86. P ADV 9 Sick Days T BG over e Set a BG limit as a reminder for testing when sick Check ketones Set the frequency of checking for ketones when sick every 4Hrs Check BG Set the frequency of checking your BG when sick every e Hrs 1 From the SETUP ADV 9 screen scroll to the desired field 2 Press to change to flashing cursor for Edit mode GB Use the O O buttons to change to desired setting 4 Press when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight gt Press To return to the Home screen scroll to Home and press NOTE e This screen is intended as a reference only Alerts are NOT triggered based on values displayed on this screen e The BG limit you set on the SETUP ADV 9 screen is different than the Low and Glucose Alerts that apply only to CGM readings See Chapter 2 in Section Il pages 87 94 for more information on CGM Alerts m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION mm Animas Vibe Insulin Pump LES m CHAPTER 10 USING ADVANCED FEATURES m A CAUTION 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 health care team In order to achieve optimal results some of these features should only be used once you have tested and fine tuned y
87. RE Alarm History Your pump History menu displays the last 30 alarm records related to insulin delivery Alarms related to CGM functions can be displayed under the CGM Menu options see Chapter 7 in Section II pages 119 122 2 Scroll up to highlight the record field Press to activate Review Mode indicated by flashing cursor 1 From the HISTORY menu select Alarm HISTORY 5 The screen displays the following Bolus Record 3 Total Daily 23 Mar 2010 Record number Dose TDD 01 13PM lt Date of alarm X XXXXXXXX o EMPTY e Time of alarm 5 N e Alarm Code El Alarm Type 5 e lt 3 Record 1 indicates the most recent record Use the O O buttons to scroll to other records 4 When finished reviewing press to exit Review Mode 5 lt is highlighted Press to return to the HISTORY menu Prime History Your pump displays the last 60 Prime and Fill Cannula records Prime and Fill Cannula records are stored as separate records 1 From the HISTORY menu select HISTORY The screen displays the following Bolus Record Total Daily 23 Mar 2010 e Record number Dose TDD 01 13PM Date of prime i ota e Time of prime Amount of prime 2 Scroll up to highlight the record field Press to activate Review Mode indicated by flashing cursor m CHAPTER 7 HISTORY FEATURE mum Animas Vibe Insul
88. SS 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 166 mw CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION m Em Technical Specifications Animas Vibe Insulin Pump NOTE When applicable testing used 23 Comfort infusion set and temperature of 23 C 19 C 73 F amp 29f Dimensions Weight Number of Basal Segments Number of Basal Programs Basal Delivery Frequency Basal rates of 0 2 U hr or higher Temp Basal Range Temp Basal Duration Extended Bolus Duration Battery Type Number of Batteries Battery Life Typical use Maximum volume infused under single fault condition Cartridge Capacity up to Storage Conditions Operating Conditions Critical Audible Alarms Pump Disposal Audio Bolus Range 8 26 x 5 08 x 2 18 centim
89. Sensor Pod Together the Sensor and Transmitter wirelessly send CGM readings every 5 minutes to your Animas Vibe Insulin Pump where the data can be viewed and analyzed on the pump s color display You can also set your pump to alert you when your CGM readings are too high or too low or are rising or falling too quickly Certain historical CGM data records are also available for review on your pump see Chapter 7 in Section Il pages 119 122 for more information You can use the Diasend Web based Diabetes Management System to track review and analyze pump CGM data on your computer Visit www diasend com animas for more information You will need to calibrate the CGM on a regular basis with fingerstick values from a BG meter Any commercially available BG meter can be used for obtaining fingerstick calibration values NSO CGM Dexcom G4 Sensor Dexsensor and Applicator Dexcom G4 Transmitter TM Dexmitter me CHAPTER 1 CGM OVERVIEW mum Dexcom CGM Setting your CGM Transmitter ID Your CGM and pump communicate using RF communication RF communication will be activated when you enter the unique CGM Transmitter ID Serial Number into the pump and start your CGM session This will ensure that communication takes place only between this pump and this CGM Transmitter Any time you replace the Transmitter you will need to enter the new Transmitter ID Serial Number into the pump Similarly i
90. Tel 33 0 4 76 86 43 22 Fax 33 0 4 76 17 19 82 Email info medimark europe com Compatible with pexcomG4 CONTINUOUS GLUCOSE MONITORING Yu 7 S en Ani Corporation em E d 1 IA 15 nes or U S patents Other patents panging Dexcom Dexmitte e et Dexsensor and Dexcom G4 are trademarks Dexcom Inc 1 Animas and Vibe are trademarks of Animas Corporation Gl cagon Emergency kit is trademark of Eli Lilly and Company Energizer is t da trademark of the Eveready Company Novo opidi and NovoLog9 b trademarks of Novo A S Humalog 15 of jan Ly m Lilly Company Apidra is a tademark ofi Aventis 4 UN 3 8 7 24 NET isa di GS Ay Alder All cther ir o copia VAS uae ho Ww OF pum m D LE siqua 7 uf y 2 gt nos Hae n G rS hig 60 Li NESE jh Ae MUT sy we The A gt EP A i 24 rS WC 9 1 2 d VLC bh d EM 21 MEO Ho a sive A NN oes l cM LOW AMA E w ai
91. Vib User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour Warning Delivery Canceled due to Low Cartridge mmm Delivery Basal or Bolus delivery exceeds insulin remaining in canceled cartridge due to low cartridge Basal or Bolus delivery stopped Message Once per occurrence and each time awakened until Message confirmed Acion Press to confirm Replace with full cartridge Beeps Vib User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour Cause Warning No Prime No Delivery 15 Cause Pump is not primed not primed No delivery All insulin deliveries stop Confirm Every 3 minutes or when awakened manually Press to confirm Disconnect reprime Beeps Vib User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mM Alerts Warnings and Alarms Warning Bolus Delivery Canceled Bolus vasa iei d 1 1 cancele y Causa User pressed function button on pump during bolus deer delivery press Delivered of U Bolus delivery stopped Confirm Every 3 minutes or when awakened manually Press to confirm If button was pressed accidentally repeat steps to deliver remaining insulin units Beeps Vib User selected every 3 minutes un
92. a support If you use tape only tape over the white adhesive patch on all sides for even support Do Not tape over the CGM Transmitter or any of the plastic parts of the Sensor Pod Do Not tape under the Sensor Pod or leave any substance on the skin where you insert the Needle 6 Attach the CGM Transmitter The CGM Transmitter wirelessly sends your CGM Sensor glucose information to the pump Once you have inserted your CGM Sensor you will need to snap the CGM Transmitter into the Sensor Pod Follow the steps below to attach your CGM Transmitter a Clean and dry the bottom of the CGM Transmitter with a damp cloth or an alcohol wipe before every use e Be careful not to touch the metal circles on the bottom of the CGM Transmitter 100 mew CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER b it may help to pinch up on your skin at the base of the Sensor Pod Place the CGM Transmitter in the Sensor Pod with the flat side facing down C Pull the Transmitter Latch over the Transmitter to snap the CGM Transmitter into place The CGM Transmitter should lie flat in the Sensor Pod You should hear 2 clicks f you do not hear 2 clicks the CGM Transmitter might not be fully snapped in d Make sure both sides of the CGM Transmitter are secure inside the Sensor Pod e Do this by sliding your first and second fingers under the edge of the Sensor Pod with your fingernails against your skin under the Transmitter Latch
93. am for correct information for your personal treatment plan Insulin to Carb Ratios I C Insulin Sensitivity Factor ISF Daily Time Slot My I C ratio je2Iuuoo D mw CHAPTER 6 MY INFORMATION Temp Basal Rate Decrease for Activity Set Temp advance Minutes to of activity yes or no set advance Activity Type Decrease My duration for Insulin on Board 08 is Basal Programming Date Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise Units Hr Units Hr Units Hr Units Hr 162 Maintenance amp Technical Information D mew CHAPTER 6 INFORMATION Basal Programming Date Program 1 Program 2 Program 3 Program 4 Weekday Other Weekend Exercise Units Hr Units Hr Units Hr Units Hr Program 1 Program 2 Program 3 Program 4 Segment Weekday Other Weekend Exercise Start Time Units Hr Units Hr Units Hr Units Hr uoneunoJu je2Iuuoo e ueuojurew D m CHAPTER 6 INFORMATION Basal Programming Date Program 1 Program 2 Program 3 Program 4 Segment Weekday Other Weekend Exercise Start Units Hr Units Hr Units Hr Units Hr 164 Maintenance amp Technical Information D ms CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION s 7 ANIMAS VIBE INSULIN PUMP WARRANTY Animas warrants that the Animas Vibe Insulin Pump will be free from defects in ma
94. amounts To move to the next STATUS screen press with highlighted at the bottom of the screen To return to the Home screen highlight Home and press Status Screen 4 Combo Bolus The screen displays the following information STATUS 4 COMBO BOLUS Most recent Combo Bolus status CANCELED 23 Mar 2010 Active or Completed or Canceled Start 07 23AM End 07 31AM Start date Delivered 3 28 9 00U o Start time o End time o Amount delivered if active shows amount delivered as of current time stored in the pump For more information on Combo Bolus see Chapter 9 in Section 1 pages 43 56 To move to the next STATUS screen press with gt highlighted at the bottom of the screen To return to the Home screen highlight Home and press Status Screen 5 Temp Basal The screen displays the following information STATUS 5 TEMP BASAL Most recent Temp Basal status ACHUE o Active Inactive 23 2010 Start 04 00PM o Start date End 06 00PM Change 50 Start time End time o 96 adjustment To move to the next STATUS screen press with highlighted at the bottom of the screen To return to the Home screen highlight Home and press 40 mw CHAPTER 8 STATUS FEATURE Status Screen 6 Pump Information The screen displays the following information STATUS 6 PUMP INFO Pump serial number S N XXXXX XX Tx S N XXXXX e CGM Transmitter
95. 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 to 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 Connect infusion set to cartridge here A WARNING Be sure to twist the Luer connector an extra quarter of a turn to ensure a secure connection If the connection is not secure insulin may leak around the cartridge resulting in under delivery of insulin 7 Put cartridge tubing assembly aside GB NOTE 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 When handling the cartridge take care not to twist or turn the plunger 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 insulin spillage Changing the Cartridge 1 Disconnect infusion set from your body 2 Unscrew the cartridge cap leaving tubing connected to the cartridge 3 With the tubing connected to the cartri
96. ast 7 6 centimeters 3 inches away from each other NOTE Always check BG levels with a fingerstick test from your BG meter 148 me CHAPTER 3 TROUBLESHOOTING GUIDELINES mum Preventing hypoglyczemia e Check BG a minimum of four times a day and more frequently with exercise e If your CGM readings suggest possible hypoglycaemia or hyperglycaemia check your BG frequently Keep accurate track of carbohydrates in the foods you eat Consult your health care professional if you are experiencing frequent hypoglycaemia or have severe low that may require the help of another person It may be necessary to adjust your basal rates bolus doses or review your BG Target goals along with your daily regimen of food and exercise If you have a low BG level hypoglycaemia follow the routine established for you by your health care team e t is important to monitor your BG frequently including periodic checks overnight e Investigate the cause of hypoglycaemia Hyperglyczemia Because your 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 BG levels Hyperglycemia high BG can occur within two to four hours after insulin delivery stops and DKA diabetic ketoacidosis can develop within four to ten hours Several things can cause a high BG value The most common
97. attery the Verify screen will continue to appear for about 8 seconds after pressing to confirm The CGM session will resume once the Home screen appears f you do not confirm the settings on the VERIFY screen you will be notified with an alarm sequence on your pump If not confirmed the pump will play 4 long tones vib every 3 minutes until the screen is confirmed e It is important to have the correct current date and time set in your pump If the pump loses the date and time setting due to the battery being removed for an extended period you will not be able to go to the Home Screen see below until you edit and confirm the settings on the Verify Screen Home Screen Once you have your pump set up the Home screen is the first screen that is e e displayed when you wake up your pump Press the O Q button to EN wake up your pump The Home screen shows the time of day an approximate battery life indicator if you have an extended bolus or temp basal currently Basal Rate active current basal rate and how much insulin remains in your cartridge 0 025U Hr You can access the Main Menu from here or you can take a shortcut to the Insulin 105U Status menu The battery life indicator is shaded to show approximate battery life remaining Battery life indicator NOTE Battery life varies by type of battery storage conditions and how long the battery has been in use Expect actual batte
98. aused by or arising from a defect of the insulin pump uoneunuoJu je2Iuuoo e ueuojurew D 165 mew CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION Maintenance amp Technical Information D ANIMAS VIBE INSULIN PUMP ACCESSORY WARRANTY Limited Product Warranty for Insulin Pump Accessories Cases Clips Skins etc Your Animas Vibe 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 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 IN
99. battery Beeps Vib MAX volume every 3 minutes until action taken If not confirmed will progress to 4 long tones m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mM Alerts Warnings and Alarms Alarm Call Service CALL SERVICE No delivery Hardware or software problem detected 52 00000001 Remove battery effect All insulin deliveries stop to silence the alarm Continuous until battery is removed Press to silence alarm for 30 minutes alarm can only be silenced once Call Customer Support or your local Animas distributor 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 see page 187 User selected every 3 minutes If not confirmed progresses to sweep vib within one hour NOTE Some Call Service Alarms have a unique sound vibration sequence and cannot be silenced by pressing Q9 GB For these Alarms the usual progression is replaced by 3 chirps vib repeated every 9 minutes for the first half hour This is followed by 4 long tones vib after that Alarm Auto Off AUTO OFF Suspended due to no key press in user set time period No delivery No button All insulin deliveries stop presses in last XX hours Continuous until confirmed Confirm Press to confirm Adjust time period in the Setup Advanced menu User selected every 3 minutes until confirmed
100. beeps or vibration pulses indicates 0 5U step size Audio Bolus 3 beeps or vibration pulses indicates 1 0U step size Step size T P 1 0U Press 4 beeps or vibration pulses indicates 5 0U step size Enter bolus amount 3 Press the Audio Bolus button once for each step size you have 0 00U programmed to reach the desired total amount For example if you are using 1 0U step size and you wish to bolus 4 units press the button 4 times You key to CANCEL will hear a beep tone or vibrate for each button press If you are using 0 5U step size and you wish to bolus 4 units press the button 8 times 4 Within 5 seconds your pump will respond with a number of confirmation beeps equal to the number of times you pressed the Audio Bolus button NOTE Do Not press any of the function buttons at this time unless you wish to cancel delivery 57 mew CHAPTER 10 USING ADVANCED FEATURES Audio Bolus Confirm 3 00 Press any other key to CANCEL Animas Vibe Insulin Pump 5 Within 5 seconds your pump will twice to ask you to confirm that you wish to activate delivery and Confirm is displayed on the Audio Bolus screen 6 Within 5 seconds press the button again to activate delivery Your 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 N
101. can result in over delivery or under delivery of insulin This chapter tells you how to set up and turn on the advanced features Chapter 10 in Section pages 57 72 covers how to use each advanced feature iS From the MAIN MENU screen select Setup Then select Advanced from the SETUP screen Bolus and press CGM Time Date Suspnd Resum History Sound Basal Advanced uljnsy Prime Rewind Status Home The SETUP ADV 1 screens allow you to program personal settings that will be used with the ezCarb and ezBG features Setup Advanced Screen 1 Personal Settings Insulin to Carb I C Ratios An Insulin to Carb 1 ratio is the amount of carbs you can cover with one unit of insulin Your health care team may recommend you use different Insulin to Carb I C ratios for different times of the day When you use the ezCarb feature your pump will automatically select the I C ratio for the current time stored in the pump This screen allows you to set different I C ratios for 12 different time slots Ratio NOTE If you set only one Insulin to Carb Ratio it will be used for the entire ISF 24 hour period BG Target 1 From the SETUP ADV 1 screen scroll up to I C Ratio Press 2 The first segment always starts at midnight The last time slot available is 11 30pm Use the buttons to scroll to the 1U grams field Press to change to flashing
102. ch 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 15 psi typical 30 psi max Bolus Volume after Occlusion release 1 0U max with occlusion sensitivity set to high 1 0U Hr basal 3 0U max with occlusion sensitivity set to low Delivery Rates Bolus under 1U 1 1 to 2 2U sec Bolus 1U or more normal delivery speed 0 5 to 0 9U sec Bolus 10 or more slow delivery speed 0 2 to 0 4U sec e Prime 1 7 to 3 3U sec Insulin Types Used Rapid acting U100 insulin or regular short acting U100 insulin Basal Rate Range 0 025 25U Hr in 0 025U Hr steps Bolus Range 0 05 35U in 0 05U steps Protection from equipment error More than 1 5 million redundant safety cross checks per day for both hardware and software functionality RF specifications Range between pump and CGM Sensor Transmitter 3 6 meters 12 feet Frequency 2 4 GHz Pump Mode Receive only 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 3 6 meters 12 feet for 24 hours Infrared communication port 168 m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION Electromagnetic Emissions The information contained in this section is intended to provide guidance on the proper operat
103. ch basal program is currently active 24 Hr Total 13 60U 0 675U Hr Insulin 105U aqra The 24 hour total for the active basal program e Units per hour currently being delivered e Insulin currently remaining in cartridge To move to the next STATUS screen press with gt highlighted at the bottom of the screen To return to the Home screen highlight Home and press Status Screen 2 IOB Last Bolus The screen displays the following information Amount of insulin currently board IOB For more information on this feature see Chapter 9 in Section 1 pages 43 56 STATUS 2 and amount of last completed bolus IDB 1 70U LAST BOLUS N Normal o C Combo normal portion only N 3 30U 9 55AM o A Audio 8 Jul 2010 e Time and date of last bolus To move to the next STATUS screen press with gt highlighted at the bottom of the screen To return to the Home screen highlight Home and press m CHAPTER 8 STATUS FEATURE Animas Vibe Insulin Pump Status Screen 3 Delivery Today The screen displays the following information since midnight and up to the STATUS 3 current time stored in the pump DELIVERY TODAY Insulin type f Temp Basal has been active e If Suspend has been active Total bolus amount delivered e Total basal amount delivered Total insulin delivered excluding prime
104. cose meter The CGM must be used with a blood glucose meter When CGM readings are missing rely on results from your blood glucose meter Symptoms related to low or high blood glucose levels should not be ignored If you have symptoms of low or high glucose use your blood glucose meter to check the CGM results Missing CGM Readings symbol appears in place of current CGM reading W99 uooxea QD 12 34 PM When the symbol appears on either the CGM Data or CGM Trend screens your pump did not receive the last CGM reading from your CGM Sensor Transmitter This is most likely due to your pump and CGM Sensor Transmitter not being in RF range IOB 5 540 Try moving your pump and CGM Sensor Transmitter closer to each other and wait at least 10 minutes for the next CGM reading to be received Also verify that the correct CGM Transmitter ID Serial Number has been entered into the pump Your pump and CGM Sensor Transmitter may lose communication when you are lying on a waterbed using a electric blanket or have other metallic objects nearby If the symbol remains on the display there is still a problem with your pump receiving CGM readings Call Customer Support or your local Animas distributor for assistance 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 see page 187 NOTE When you see instead of a CGM reading taking additional finge
105. ction amount calculated from the BG CORRECT screen IOB refers to the 8 amount from previous bolus In this example the feature is not turned on Below the suggested Total amount is the bolus amount entry field where you can choose to deliver the suggested amount or adjust the amount as needed This field will display 0 00U and will be highlighted and flashing Press the button once to change the amount to match the suggested bolus amount Then use the buttons to adjust the amount if necessary When you have the desired delivery amount displayed press NOTE e Calculated total units will be rounded to the nearest 05 units e f the maximum bolus limit you set in Advanced Features is less than the suggested Total bolus amount on the Bolus Total screen the bolus amount entry field will change to that limit rather than the suggested Total amount when you press the button once aqra GB 6 Go is highlighted Press to deliver as a Normal Bolus or scroll to the Type field to select Combo Bolus then select Go If you selected the Combo Bolus option you will begin the steps for delivering the ezCarb units as a Combo Bolus see Combo Bolus pages 68 69 in this chapter The bolus amount you entered on the Bolus Total screen in step 6 will appear in the Total field on the first Combo Bolus screen 7 After the bolus is delivered you wi
106. d The Alert screen Clear Program shown here is displayed If you do wish to clear all the basal segments of the deletes all selected program scroll to Clear Program and press basal segments in this program If you do not wish to clear all the basal segments scroll to Basal Options Clear Program and press The BASAL OPTIONS screen will be displayed rei If all segments of your active basal program are set to 0 000 U Hr your pump GB will not deliver any basal insulin Each time you wake up your pump the Your active Alert screen shown here is displayed If you have turned on the sound for Basal s program Alerts you will also be notified by a beep or vibrate This Alert screen does is empty not progress to higher audible alarms You have the option to either select 0 000U Hr Confirm to quickly go to the MAIN MENU screen or select Basal Menu to Confirm reset rates in your active program For more information see Chapter 11 in Section pages 73 84 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 decrease your basal rate by up to 90 in 10 decrements or increase your basal rate by up to 200 in 10 increments You can also set to OFF You can set the duration up to 24 hours in half hour increments If you have activated
107. d in the Owner s Booklet or if you have a question or need assistance with your pump contact Customer Support or your local Animas distributor 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 see page 187 We understand that you may have questions and concerns when using a new product Please do not hesitate to call for assistance If you are having problems with your diabetes management please contact your health care team 1 GB CHAPTER 1 INSULIN PUMP OVERVIEW Important Note Do Not Remove the 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 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 can be purchased by calling Customer Support or your local Animas distributor In the United Kingdom call free p
108. d or essage until pump goes to sleep action Select Clear Program or Basal Options Beeps Vib User selected one time No progression Alert Basal Program Display Change 1 weekday Changing display of basal programs from 4 to 1 but must be the Cause 1i t tlv acti active program program 1 is not currently active to change the basal display Effect Requires user confirmation to continue setting Confirm Displayed until confirmed or until pump goes to sleep Acion Press to confirm Beeps Vib User selected one time No progression Animas Vibe Insulin Pump Warning Basal Delivery Suspended Basal Edit was not saved Basal edit not saved Basal delivery suspended Edit Basal effect Basal delivery stopped Displayed when manually awakened until confirmed Press to select Edit Basal Review basal edits and select Save Review Beeps Vib User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour 76 mums CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS mM Alerts Warnings and Alarms Warning Suspend No delivery Cause Pump suspended manually Pump is suspended effect All insulin deliveries stop p Displayed each time pump is awakened until confirmed Message and once every 15 minutes until action is taken action Press to confirm Resume delivery User selected once every 1
109. d press GB Setup Advanced Screen 1 Personal Settings BG Target Ranges A BG Target is your personal goal for keeping your BG levels under control A BG Target may be set as an actual range with a minimum and maximum value or a single value Your health care team may recommend you use different BG Target ranges or values for different times of the day The BG Targets ranges or values you set in the pump are important as they are used in calculating suggested BG correction bolus amounts when using the ezBG and ezCarb features on your pump see Chapter 10 in Section pages 57 72 When the pump calculates a suggested BG correction bolus it begins the calculation by determining the difference between your current BG and the BG Target range value for the current time of day stored in the pump That number along with your ISF is then used to calculate a BG correction bolus amount that would bring your current BG in line with your BG Target range value In addition to the BG correction bolus amount there are other factors that are used in calculating suggested insulin bolus amounts when using the ezBG and ezCarb features on your pump These include the amount of Insulin on Board IOB from a previous bolus your ISF and your I C Ratio For more information on IOB including activating the IOB feature on your pump refer to Setup Advanced Screen 8 Insulin on Board IOB setting on page 53 i
110. dge pull cartridge straight out of your pump 4 Disconnect tubing from cartridge and discard Proceed with filling the new cartridge as outlined above m CHAPTER 3 GETTING YOUR PUMP READY mm Animas Vibe Insulin Pump Priming your Pump and Infusion Set NOTE As each step is completed the check box on the ezPrime menu will be shaded WARNING Never prime tubing or tighten the cartridge cap while the infusion set is connected to your body Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin and possible injury or death If your pump sustains internal damage the amount of unintended insulin delivery could be significant This could result in serious injury or death from hypoglycamia 1 Make sure you are disconnected from your pump MAINMENU 2 From the MAIN MENU select Prime Rewind Bolus CGM Suspnd Resum History Basal Setup Prime Rewind Status Home REWIND MOTOR 0 Disconnect O Load Cart infusion set On the ezPrime menu Rewind is highlighted Prime from your body qe Fill Cannula Press The REWIND MOTOR screen is displayed Go Rewind Cancel REWIND MOTOR REWIND ACTIVE Disconnect 4 Scroll up to Rewind Press Your pump will infusion set Please wait from your body Full rewind required NOTE Before starting the rewind your pump will Go Rewind vibra
111. e f 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 hour s worth of insulin delivered Sounds Setting Changing The sound menu only adjusts sounds for pump related functions It does not activate 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 9 in Section pages 43 56 Refer to Chapter 2 in Section II pages 87 94 to set CGM related sounds Your pump comes pre loaded with a tune for most Alerts Reminders and Alarms on medium and high volume settings This tune plays only for the initial audible notif
112. e Chapter 9 in Section pages 43 56 While the pump is in sleep mode pressing the button will awaken the pump to one of the CGM Trend graphs or the CGM Data screen See Chapter 6 in Section pages 109 118 NOTE When viewing your pump display in bright sunlight it is recommended you shade the screen or move to a shady area for best visibility e If your pump goes to sleep and an error has not been cleared pressing the button will awaken the pump to the error screen This will continue until the error condition has been cleared Audio Bolus ezBolus This button allows you to program a bolus without looking at your pump by using audible tones or vibrate pulses 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 NOTE 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 or vibration feedback to program a bolus See Chapter 9 in Section pages 43 56 A WARNING Removal of the Audio Bolus ezBolus button could damage the pump In addition it could affect the integrity of the pump and compromise the pump s waterproof capabilities m CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP mm Battery Cap Vent This cap unscrews easily with a coin to replace and secure your battery There is an o ring around
113. e correct Incorrect basal rates can result in under or over delivery of insulin See Reviewing Basal Programs below Reviewing Basal Programs program Press A1 WEEKDAY Total 13 60U Total 13 60U Start U Hr 2 Scroll to Review from the BASAL OPTIONS screen Press Your basal segment settings are Xm shown 5 on first screen 5 on second screen and 2 Nem on last screen If you have more than 5 segments programmed scroll to Next to see second and third Main screens as desired 0 675 Options 3 When finished Options is highlighted Press 4 Scroll to Main Menu and press The MAIN MENU screen is displayed The active basal program continues 5 If reviewing an inactive program and you wish to activate it select the program you wish to activate from the BASAL MENU screen Press 6 Select Go from the 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 m CHAPTER 5 USING BASAL PROGRAM FEATURES mM Clearing Basal Programs BASAL OPTIONS A1 WEEKDAY This feature allows you to clear all information from a basal program Total 13 60U 1 From the BASAL MENU scroll to desired program 2 From the BASAL OPTIONS screen scroll to Clear Press If you press to select Clear your pump will check to be sure you want to clear all the segments of the basal program selecte
114. e of any insulin with lesser or greater concentration can result in serious injury or death Then SETUP ADV 8 screen allows you to SETUP ADV 8 Insulin on Board e Turn the IOB feature on or off IOB 2 Select the duration from 1 5 to 6 5 hours in half hour increments Duration 4 0 Hr 1 From the SETUP ADV 8 screen scroll to the desired field 2 Press to change to flashing cursor for Edit mode Use the O O buttons to change to desired setting Animas Vibe Insulin Pump Press 9 when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight gt gt Press To return to the Home screen scroll to Home and press NOTE Your pump is constantly tracking 8 so when you turn on the feature your pump will immediately take into account the current amount remaining from previous bolus doses within the time frame you have selected during set up of the feature me CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Setup Advanced Screen 9 Sick Day Guidelines During your pump training your health care team will discuss guidelines to use when you are sick such as when to test your BG or ketones Your pump provides a convenient way to store some of these guidelines For more information on sick day guidelines refer to Chapter 4 in Section Ill pages 157 158 and contact your health care team This screen allows you to SETU
115. ec 2010 of the screen and press so that the highlight over the record number is 16 17 PM flashing Then use the buttons to scroll to other CGM Alarm records 206 00000000 0000000000 Transmitter Out of Range CGM History To return to the CGM History screen highlight CGM History any Alert record screen and press 121 m CHAPTER 7 CGM HISTORY SCREENS Dexcom CGM 122 m CHAPTER 8 COMPLETING A CGM SESSION Each CGM session should last up to 7 days 168 hours including a 2 hour startup period after which you will need to replace the CGM Sensor and start a new CGM session You can also choose to end the CGM session early or the CGM session might end earlier than the 7 days due to a CGM Sensor failure CGM Sensor Expiration When you are within six hours of the expiration time your pump will begin prompting you with a series of reminders that your session will be expiring shortly You will be reminded with 6 hours remaining 2 hours remaining and CGM Session 30 minutes remaining Press to confirm the Warning at any of the reminder Expires In times 06 00 ZI During this time your pump will continue to receive CGM readings Once the final 30 minutes ends you will be prompted that your CGM session has ended Press to confirm the CGM Warning and return to the CGM Menu Expired screen You will no longer receive CGM readings on your pump until you CGM Session replace
116. eck BG one to two hours after infusion set change Always check that your cartridge has enough insulin to last through the night before going to bed Unless otherwise recommended by your health care team set the volume to high for all warnings and alarms before going to sleep 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 Interference with your pump insulin delivery by cell phones can occur if worn in close proximity It is recommended that you wear your pump and cell phone at least 15 2 centimeters 6 inches apart Cell phones will not interfere with CGM functions on your pump e f 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 f you drop your 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 your pump may impact the battery contact and or the waterproof feature of your pump Call Customer Support or your local Animas distributor if you identify or
117. ed by your health care 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 selection allows you to personalize the settings and features of your pump as well as add advanced features to the menu Your health care 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 selection enables you to properly align the cartridge and piston rod as well as prime your infusion set tubing and fill your cannula or needle before connecting to your pump Status This selection allows you to quickly see your current most recent settings and pump deliveries mw CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP mm Animas Vibe Insulin Pump LES 7 CHAPTER 3 GETTING YOUR PUMP READ Y A WARNING Before proceeding with this chapter you should have completed your pump training To complete this section you will need the following items e Animas Vibe Insulin Pump Energizer Lithium Ultimate 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 at room temperature see allowed insulin types page e Skin prep such as IV Prep to clean and prepare
118. ed until 9 confirmed and action is taken Dexcom CGM Press to confirm Take fingerstick BG test and enter value in pump Do Not enter a fingerstick BG value if ANT or appear on the CGM Trend or Data screen Beeps Vib Silent no Beeps Vib If confirmed snooze for 15 minutes No progression 128 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS mum Warning BG Value Required For Recalibration Cauca The BG value entered has not been accepted for Startup calibration or calibration update Insulin deliveries continue CGM continues but with a possible CGM data gap Displayed each time pump is awakened until confirmed and action is taken Press to confirm Take another fingerstick BG test and enter value in pump You will continue to be reminded to enter a valid BG value until the BG value is accepted for recalibration Do Not enter a fingerstick BG value if ANT or appear on the CGM Trend or Data screen User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression Warning Use Fingerstick BG For Treatment Decisions and CGM Calibration Appears at start of every CGM session J effect Insulin deliveries continue CGM continues Message Displayed each time pump is awakened until confirmed Press to confirm Take fingerstick BG test before adjusting insulin dose eating exercising or making any other therapeutic adjustments Beeps Vib Use
119. edure e Do Not bring pump or CGM Transmitter Sensor into the same room CARDIAC where the procedure is being performed CATHETERIZATION e Teflon plastic infusion set can remain in Other types of infusion sets must be removed COLONOSCOPY e Pump infusion set and CGM Transmitter Sensor can remain on in Do Not bring pump into the same room where the procedure is being performed CT SCANS rU m TE Teflon plastic infusion set can remain in Other types of infusion sets must be removed e Pump infusion set and CGM Transmitter Sensor can remain on in Do Not bring pump or CGM Transmitter Sensor into the same room where the procedure is being performed ELECTRO CAUTERY M o Teflon plastic infusion set can remain in Other types of infusion sets must be removed LASER SURGERY e Pump infusion set and CGM Transmitter Sensor can remain on in Do Not bring pump or CGM Transmitter Sensor into the same room where the procedure is being performed Teflon plastic infusion set can remain in Other types of infusion sets must be removed Do Not bring pump or CGM Transmitter Sensor into the same room NUCLEAR STRESS TEST where the procedure is being performed myocardial perfusion imaging Teflon plastic infusion set can remain in Other types of infusion sets must be removed mw BEFORE YOU BEGIN Medical Procedure Device User Patient or HCP administering the procedure Do Not
120. een will appear to remind you not to rely solely on CGM readings for making therapeutic adjustments Always use Always use Fingerstick BG for Treatment Decisions and CGM Calibration Fingerstick BG for This Warning will appear every time you begin a new 2 hour CGM startup Treatment period Press to confirm the Warning and continue with the 2 hour startup Decisions session After pressing Q9 you will go to the CGM Trend screen see Chapter 6 and CGM Calibration in Section Il pages 109 118 Once you start a CGM session you can use the CGM Data and Trend screens on your pump to view the progress of the 2 hour startup period Keep your pump within 3 6 meters 12 feet of your CGM Sensor Transmitter during the 2 hour startup period for best communication You can check that your devices are communicating by pressing the contrast button CGM shortcut on your pump while the pump is in sleep mode to display one of the CGM Information screens see Chapter 6 in Section II pages 109 118 If a CGM Trend screen is displayed a shaded box will appear on the top left of the screen to indicate the progress of the CGM startup period The CGM session will start with the box completely shaded but the shaded area will gradually diminish over the 2 hour startup period The shaded box also appears on the CGM data screen Similarly the graph area on CGM Trend screens will be shaded dark grey to start but the grey area
121. egulations uoneunuoJu je2Iuuoo e ueuojurew D 143 m CHAPTER 1 CARE AND MAINTENANCE memm 144 dD m CHAPTER 2 LENS PROTECTION FILM APPLICATION INSTRUCTIONS Your pump display Lens Protection Film Kit contains 3 lens protection films the film application solution 901 002 01 and a rubber squeegee Follow the instructions below for proper application 1 Wash your hands with mild soap and water 2 Slowly remove existing lens protection film Do Not use heat or metal instruments 3 Clean lens with a dry lint free cloth Film can be applied without disconnecting pump 4 Spray fingers with film application solution 901 002 01 e Solution contains isopropyl alcohol e Shake before use e Do Not ingest 5 Remove lens film from paper backing Touch with wet fingers only Hold adhesive side up Do Not let film adhere to itself 145 2 uoneunuoJu je2Iuuoo e ueuojurew D m CHAPTER 2 LENS PROTECTION FILM APPLICATION INSTRUCTIONS 6 Spray entire film adhesive area and lens with solution NOTE Before proceeding make sure the film orientation matches the frame orientation of the lens 7 Place film onto lens Place adhesive side down facing lens Do Not press into place e f needed remove film reapply solution and reposition film to align all edges 8 Pull squeegee firmly across film e Sta
122. emia FOOD INTAKE SUGGESTED SOLUTION Check bolus amounts and times Bolus only enough to lower your BG to normal level Low carbohydrate intake for bolus Measure carbohydrates accurately See dietitian for carb counting review May need recalculation of C ratio consult with health care team Improper timing of bolus Match timing of bolus with intake of food Check BG prior to meal bolus and adjust accordingly Alcohol consumption May cause hypoglycemia or may cause hyperglycemia Eat food when drinking alcohol Be cautious with bedtime bolus Always check BG before going to bed Check BG at 3 am Consult health care team POSSIBLE CAUSE OF LOW BG Did not Suspend pump or activate Temp Basal ACTIVITY SUGGESTED SOLUTION Consult health care team for guidelines for use of Temp Basal rate during exercise Low carbohydrate intake prior to exercise If not decreasing insulin prior to or during exercise may need to eat foods containing carbohydrate prior to exercise Unplanned activity shopping If BG is below 5 6 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 Consult with health care team for specific guidelines Insulin infusion site is too close to the CGM Sensor insertion site Make sure the sites are at le
123. er selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed If confirmed snooze for user selected snooze time No progression 134 CGM m CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS m Warning CGM Session Stopped Cause Beeps Vib Warning CGM Sensor Failure Cause effect Insulin deliveries continue CGM ends Beeps Vib CGM session stopped as a result of another Warning CGM Session Stopped Insulin deliveries continue CGM session stops Displayed each time pump is awakened until confirmed Press to confirm Replace CGM Sensor and start new CGM session User selected under CGM Setup menu options every 3 minutes up to 3 times or until confirmed No progression CGM Sensor Failure N52 Sensor error indicating that Sensor is not functioning properly Insulin Delivery Continues Confirm Displayed each time pump is awakened until confirmed Press to confirm Call Customer Support or your local Animas distributor for assistance 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 see page 187 User selected under CGM Setup menu options every 3 minutes up to 3 times or until confirmed No progression 135 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning CGM Sensor Error 0
124. eters 3 25 x 2 00 x 0 86 inches Approximately 105 grams 70 ounces 12 per Program 4 every 3 minutes 90 to 200 in 1096 increments OFF 0 5 hrs to 24 hrs 0 5 hrs to 12 hrs 0 5 hr increments 1 5 Volt Energizer AA Ultimate recommended Lithium or 1 5 Volt AA Alkaline optional 1 approximately 3 to 4 weeks for a Lithium Ultimate Battery Max 2 0U 2 0 mL or 200 units 20 C 4 to 60 C 4140 1096 to 10096 relative humidity including condensation 500 Hpa to 1060 Hpa Batteries must be removed during storage periods exceeding 2 weeks 45 C 4409 P to 40 C 104 F Outside these temperatures the flow accuracy and time to occlusion could be compromised 700 Hpa to 1060 Hpa 2096 to 9096 relative humidity including condensation up to 3048 meters 10 000 feet 50 dB A at 1m min per IEC 60601 2 24 Contact Animas Corporation or your local Animas distributor see page 187 for pump disposal information 0 1 2 0U in 0 10 step 0 5 10 0U in 0 50 step 1 0 20 0U in 1 0U step 5 0 35 0 5 0U step 167 uoneunuoJu je2Iuuoo e ueuojurew D m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION m Maintenance amp Technical Information D Performance Characteristics Flow Rate Accuracy Delivery Mode Accuracy Maximum Time to Occlusion Alarm Low occlusion High occlusion sensitivity setting sensitivity setting Basal bolus delivery Certain factors su
125. etoacidosis 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 Any uncertainty as to what to do to take care of yourself Never omit 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 BG as prearranged with your health care team e You may need to temporarily increase or decrease your basal rate by using the Temp Basal feature as prearranged with your health care team Medication Always let your health care team know ALL medications you are taking Even medications you are taking for other reasons may impact your diabetes management so it is important that you always let your health care team know all the medications you are taking A CONTRAINDICATION Use of acetaminophen containing medications while the CGM Sensor is inserted may affect the performance of the CGM Blood and Urine Testing Check your BG before your usual mealtime and every 2 4 hours if indicated Test your blood or urine for ketones at least 4 times a day or according to instructions from your health care team Fluids and Diet Always follow your health care team s sick day guidelines Fluid intake is essential with any illness Consume 240 ml 8 3 ounces of fluid pe
126. ew Insulin delivery currently suspended Active CGM CGM data session continues but CGM data not available on pump If you want to temporarily suspend insulin delivery but still view CGM readings do not use the suspend delivery feature Instead you can program a temporary basal of 0 units for the time period you want basal delivery suspended and still be able to view CGM readings Displayed once for 4 seconds action Resume pump operation Beeps Vib User selected under CGM Setup menu options one time No progression Dexcom CGM 140 Section 111 Care and Maintenance and Other Technical Information About Your Animas Vibe System Section of this Owner s Booklet covers safety maintenance troubleshooting lifestyle and technical information about your Animas Vibe System Care and Maintenance of your Animas Vibe Insulin Pump The Vents Your pump features a redundant Vent Safety System Vents serve two purposes First they allow air to enter and exit your 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 your pump Battery Cap with O ring and Vent Your battery cap contains an o ring and vent The vent 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 waterproo
127. f It is recommended that you change the battery cap vent every six 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 Customer Support or your local Animas distributor see page 187 to order an extra battery cap O ring Battery Cap Vent Hole A WARNING Under no circumstances should you introduce any kind of sharp object into the vent openings to clean them Doing so could compromise your pump s waterproof capabilities If at any time you suspect the vent opening is clogged replace the battery cap Cleaning A CAUTION Do Not use household or industrial cleaners chemicals solvents bleach scouring pads or sharp instruments to clean your 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 Never put your pump in a microwave oven or baking oven to dry it Use a soft towel Never clean the battery or insulin cartridge compartments 141 1 uoneunoJu je2Iuuoo e ueuojurew dD CHAPTER 1 CARE AND MAINTENANCE mum General Wear and Tear If you drop your 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 tha
128. f you do not understand something or have questions ask your health care team or call Customer Support or your local Animas distributor 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 see page 187 Your pump is designed to deliver insulin reliably but because your 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 BG you must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason Your 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 Never start the Prime Rewind sequence on your pump while the infusion set is connected to your body The Prime Rewind sequence includes steps for rewinding the pump motor loading an insulin cartridge and tightening the cartridge cap and priming the infusion set tubing Failure to disconnect your infusion set from your body before performing these steps can result in over delivery of insulin and possible injury or death If your pump sustains internal damage the amount of unintended insulin delivery could be significant This could result in serious injury or death from hypoglycamia You must take a fingerstick test with your BG meter and use that BG value to make any insuli
129. f your pump is replaced you will need to enter the ID or S N into the new pump NOTE CGM menu options are not available while pump is suspended 1 For the initial setup remove the CGM Transmitter from the tray and wait 10 minutes for the CGM Transmitter to be activated and ready for use 2 From the MAIN MENU screen scroll to CGM and press Suspnd Resum History Basal Setup Prime Rewind Status Home Scroll to Setup on the CGM Menu screen press BG Cal Trend Graph Start Stop History CGM Setup Sounds 4 Scroll to Transmitter and press High Alert The CGM Transmitter screen will be displayed and Low Alert a ee Rise Rale S N 00000 CGM Setup will be highlighted Fall Rate Out of Rang Transmitter CGM Menu CGM Setup 2 WDD euooxeg 111 m CHAPTER 2 CGM SETTINGS CGM S N 0000 CGM Setup CGM Setup CGM Setup S N 687AB CGM Setup 5 Scroll to the S N field The last digit will be highlighted Scroll to the first digit and then press so that the first digit is flashing NOTE The ID Serial Number appears on the underside of the Transmitter The serial number should begin with 6 or 7 6 Use the O O buttons to enter the first number letter of the CGM Transmitter ID Serial Number found on the underside of the Transmitter Press to move to the next digit and press again
130. for 0 5 cycle on power supply 40 96 Ur input lines 60 96 dip in Ux IEC 61000 4 11 for 5 cycles 70 96 30 96 dip in Ur for 25 cycles 5 96 Ui 695 96 dip in Ur for5s Power Frequency 400 A m Power frequency magnetic fields 50 60 Hz pump should be at levels characteristic magnetic field IEC 60601 2 24 Of a typical location in a IEC 61000 4 8 typical commercial or hospital 3 A m environment CGM Transmitter NOTE Ur is the a c mains voltage prior to application of the test level Maintenance amp Technical Information D 170 m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION Guidance and Manufacturer s Declaration Electromagnetic Immunity The Animas Vibe System is intended for use in the electromagnetic environment specified below The customer or the user of the Animas Vibe System should assure that it is used in such an environment Immunity Test Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess
131. fore You Start Wash your hands thoroughly Be sure your pump has sufficient battery life to avoid running out of battery power during use Check that the date and time on your pump are correct Make sure you have removed the CGM Transmitter from its tray and have waited 10 minutes for it to be activated and ready for use If this is a new CGM Transmitter make sure the correct Transmitter ID Serial Number has been entered into your pump see Chapter 2 in Section II pages 87 94 Check the expiration date on the CGM Sensor before you start to make sure you are not using an expired CGM Sensor The expiration date format is YYYY MM DD Quality check QC your BG meter per the manufacturer s instructions to make sure it is providing you the best test results for calibration e g check the code number and use the control solution if applicable to your BG meter Clean the bottom of the CGM Transmitter with a damp cloth or alcohol wipe and dry before you start a new CGM Sensor session Make sure the date and time on your pump matches the date and time on your BG meter mw CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER Inserting a new CGM Sensor and Transmitter Review the CGM Sensor Applicator Review the CGM Sensor Applicator picture below before using a new CGM Sensor Safety Lock Plunger Transmitter Key j Applicator Needle Sensor Probe inside Collar Transmitter Latch L
132. from the previous ezBG screen IOB refers to the IOB amount from a previous bolus Below the suggested amount Total is the bolus amount entry field where you can choose to deliver the suggested amount or adjust the amount as needed This field will display 0 00U and will be highlighted and flashing Press the button once to change the amount to match the suggested bolus amount Then use the buttons to adjust the amount if necessary When you have the desired delivery amount displayed press With Go highlighted press to deliver the bolus NOTE e f the BG amount on the ezBG Total screen is a negative number the suggested Total amount will be set to 0 00U Calculated total units will be rounded to the nearest 05 units e If the maximum bolus limit you set in Advanced Features is less than the suggested Total bolus amount on the Bolus Total screen the bolus amount entry field will change to that limit rather than the suggested Total amount when you press the button once 6 After the bolus is delivered you will be prompted on the display to decide if the BG value you just entered should be used to calibrate your CGM see Chapter 5 in Section Il pages 105 108 Select YES and press Q9 to use this BG value for CGM calibration If the pump display times out before you select Yes the BG value will not be used for CGM calibration DELIVERING 2 80U Press any function button to cancel
133. ge or value is set by first selecting a BG Target and then a amount that will define the minimum and maximum of the range For example a BG Target of 6 7 mmol L and a amount of 0 6 mmol L means the Target range will be set to 6 1 7 3 mmol L If you prefer to correct your BG to one target value rather than a range set the amount to 0 NOTE If you set only one ratio it will be used for the entire 24 hour period Ratio 1 From the SETUP ADV 1 screen scroll up to BG ISF Target Press BG Target 2 The first segment always starts at midnight The last time slot available is 11 30pm Use the Q buttons to scroll to the BG Target field Press to change to flashing cursor for Edit mode 4 Use the buttons to change to desired setting aqra GB 5 Press when setting is made 6 Scroll to the range field Press to change to flashing cursor for Edit mode Time 7 Use the O O buttons to change the range as desired Press Qj 12 00A 8 To move to the next BG Target screen scroll to gt and press Baza mmol L 9 Scroll up to the Time field and press to change to flashing cursor for Edit mode 10 Use the O O buttons to change the segment start time Press Q9 11 Scroll to the BG Target field Press to change to flashing cursor for Edit mode 6 7 mmol L 12 Use the O O buttons to change to desired setting
134. ging sensation 5 Select either 1 basal program or 4 basal programs to be displayed in the BASAL MENU 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 will be displayed to remind you 1 From the SETUP ADV 2 screen scroll to the desired field 1 weekday 2 Press to change to flashing cursor for Edit mode must be the active program to change the Use the O O buttons to change to desired setting display setting 4 Press when setting is made To move to the next Setup Advanced screen scroll to the bottom of the screen and highlight gt Press Q9 To return to the Home screen scroll to Home and press me CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Setup Advanced Screen 3 Insulin Limits You can program your pump to control the maximum amount of basal bolus daily insulin and insulin delivered in a 2 hour period Your pump will alert you when you exceed these amounts This screen allows you to Set maximum basal delivery per hour Max LIMITS Basal 10 00U Hr e Set maximum bolus amount Bolus 35 00U Daily 200 00U eHr e Set maximum daily 24 hour delivery amount Your pump checks that total insulin delivery each 24 hour period running from midnight of the previous day to midnight of the current day does not exceed this limit Set maximum 2
135. gram a bolus using audible tones or vibrate pulses to confirm programming and delivery Programming Basics e Use the O O buttons to scroll to the desired selection and then press the button to select If the cursor is flashing it means your pump is in Edit Mode and by scrolling with the buttons you can edit the flashing field e Once you have finished editing press the button to confirm your entry and to exit the Edit Mode e f your pump display turns off before you have had a chance to confirm your entry that entry will not be saved Be sure to check your edits entries the next time you turn your pump display on Display Screen All programming operations warnings and alarms are shown on the display screen mw CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP mm Animas Vibe Insulin Pump Contrast Button CGM Shortcut 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 button on top of your 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 To adjust contrast during a Call Service alarm you must use the button Se
136. hat snaps the Transmitter into the Sensor Pod It is removed after the Transmitter is snapped in CGM trends Trends let you see the pattern of your glucose levels over time you can see where your glucose levels have been and where your glucose levels are headed The pump displays five glucose Trend Graphs the 1 Hour 3 Hour 6 Hour 12 Hour and 24 Hour Graphs Each Trend Graph shows glucose trends over the amount of time shown on the screen CGM trend rate of change arrows Arrows on CGM Data and Trend screens that indicate how fast your CGM readings are changing Seven different arrows show you when your glucose speed and direction change combo bolus Your pump lets you split a bolus amount into 2 parts a Normal portion and an Extended portion The Normal portion is delivered all at once and the Extended portion is delivered over an extended period of time that you set A combo bolus is useful when eating foods that contain carbs that are absorbed more slowly over time continuous glucose monitoring CGM The automatic measurement of glucose levels every few minutes using a method device other than a traditional BG meter dawn phenomenon More insulin may be required in the early morning hours of normal Sleep to counteract the release of several hormones that act to increase BG levels This me APPENDIX A GLOSSARY increased need for insulin is known as dawn phenomenon and may cause a person with diabete
137. he injection site If you experience a broken CGM Sensor report this to Customer Support or your local Animas distributor 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 see page 187 For patients undergoing an MRI with a retained wire broken off from a CGM Sensor in vitro MRI testing did not detect any safety hazards There was no significant migration or heating of the wire and imaging artifacts were limited to the area around the wire 124 CHAPTER 9 REMOVING THE CGM TRANSMITTER AND SENSOR At the end of every CGM session you will need to remove your CGM Transmitter and Sensor First gently peel up the adhesive patch from your skin to pull out your Sensor Probe with the CGM Transmitter still in the Sensor Pod Then remove the CGM Transmitter from the Sensor Pod and keep it for your next CGM session The CGM Transmitter can be used for several CGM sessions up until the 6 month Transmitter warranty expires When it is time to replace your CGM Transmitter follow proper instructions for disposal as the Transmitter contains a battery See Chapter 1 in Section Ill pages 141 144 for information on disposal To remove the CGM Transmitter from the Sensor Pod you can use either method below Method 1 The Safety Lock Transmitter Key that was detached from the Applicator can be used as a tool to remove the CGM Transmitter
138. hone 0800 055 6606 In Ireland call 1 800 812 715 All other countries call your local Animas distributor see page 187 Please note that the Animas Vibe 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 Animas Vibe Insulin Pump ms CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP An insulin pump is a tool to allow you to better manage your diabetes When connected to a properly inserted infusion set your pump delivers insulin at a continuous level basal rate 24 hours a day You program delivery of an immediate dose bolus of insulin to cover food eaten or to correct high BG Your pump is engineered and manufactured to the highest standards of quality Get to Know Your Animas Vibe Insulin Pump Contrast button CGM shortcut Up button Down button GB lt Audio bolus ezBolus button Display Screen OK button Main Function Buttons There are 4 buttons for main programming functions The and buttons allow you to move through screen selections and to scroll up and down to enter values such as a bolus amount The button allows you to select an item or activate a function The Audio bolus ezBolus button allows you to pro
139. hour delivery amount Your pump checks that total insulin delivery over each rolling 2 hour period does not exceed this limit 1 From the SETUP ADV 3 screen scroll to the desired field GB 2 Press to change to flashing cursor for Edit mode 3 Use the buttons to change to desired setting 4 Press Q when setting is made move to the next Setup Advanced screen scroll to the bottom of the screen and highlight gt Press To return to the Home screen scroll to Home and press A CAUTION Should you attempt a delivery that exceeds the limits you have set your pump will alert you and display a text message See Chapter 11 in Section 1 pages 73 84 for additional information m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION mm Animas Vibe Insulin Pump Setup Advanced Screen 4 Language Setup Display Timeout Contrast and Battery Type You can customize how information will be displayed on your pump and what type of battery you will use This screen allows you to Language Select a different language ENGLISH s Display Timeout e Set the length of time your display stays on before timing out to save in 50 secs battery life Contrast 15 30 45 or 60 seconds Battery Lith e Select a contrast setting Select Lithium recommended or Alkaline battery type If you select the wrong battery type the alarm screens may
140. ication 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 mw CHAPTER 3 GETTING YOUR PUMP READY The options from the first SETUP SOUND menu are listed below Normal Bolus Sound and Temp Basal Sound can be set to one ofthe following Vibrate Vib Low volume L Medium volume M High volume H or can be shut off OFF completely For safety reasons some sounds cannot be turned off Normal Bolus Sound Audio Bolus Sound OFF is not an option for this sound setting Temp Basal Sound The options from the second Setup Sound menu are listed below They can be set to one ofthe following Vibrate Vib Low volume L Medium volume M High volume or can be shut off OFF For safety reasons some sounds cannot be turned off Alert Sound Reminder Sound OFF is not an option for this sound setting Warning Sound OFF is not an option for this sound setting Alarm Sound OFF is not an option for this sound setting GB A CAUTION Unless otherwise recommended by your health care 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 Q9 button 2 Scroll to Sound Press the butto
141. ify health care team with signs or symptoms of infection at your insulin infusion site or CGM Sensor insertion site OTHER POSSIBLE CAUSE OF HIGH BG SUGGESTED SOLUTION Medications steroids terbutaline acetominophen other hormone treatments Inform health care team of all medication changes or additions Infection illness virus Refer to Sick Day Management Guidelines Consult health care team May need to use Temp Basal or set additional Basal Program Insulin requirements may increase in later trimesters P Consult health care team May need recalculation of basal or bolus doses Consult Weight changes health care team WARNING Consult your health care team before making any changes in your basal rates bolus calculation settings When in doubt change it out 1 Follow guidelines provided by your health care team 2 Change infusion set 3 Check for ketones 4 Take rapid acting insulin by injection uoneunoJu je2Iuuoo e ueuojurew 151 m CHAPTER 3 TROUBLESHOOTING GUIDELINES mm Problems with Infusion Sets Sites and Cartridge 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 POSSIBLE PROBLEMS SUGGESTED SOLUTION Air bubbles in tubing Always fill your pump cartridge with room temperature insulin Check Luer lock connectio
142. ile preventing water from entering the compartment NOTE The battery cap should be replaced every six months or sooner if the o ring or cap is damaged the vent is clogged See Chapter 1 in Section Ill pages 141 144 5 Insert the Energizer Lithium Ultimate AA 1 5V battery into the battery compartment with the positive 4 end going in first Energizer Lithium Ultimate AA battery 6 Replace the cap by turning clockwise until you cannot see the o ring Then slowly tighten the cap until flush with pump body NOTE Using excessive force to tighten the battery cap can cause your pump case to crack Cracks chips or damage to your pump may impact the battery contact and or the waterproof feature of your pump 7 Each time you change the battery your pump will run a series of self tests which will last a few seconds An all black screen with an hourglass symbol will appear followed by the VERIFY screen Your pump will give a beep to alert you to verify or change the time date language and battery type 10 m CHAPTER 3 GETTING YOUR PUMP READY 8 Check the displayed time date battery type and language If correct scroll down to highlight Confirm and press the button The Home screen will be displayed For more details on changing the time and date see Setup Basics Setting Changing Time and Date pages 11 12 in this chapter ART Basal Rate NOTE The time and date must be
143. imitations 10 RH T 60 C Temperature Limitations 20 C 4 A Caution Consult Owner s Booklet On the front of your pump Up Arrow button Down Arrow button o OK button On the top of your pump Contrast button CGM shortcut On the back of your pump Shock Protection Type BF Medical S N Serial Number Equipment eal Manufacturer Date of Manufacture Consult Owner s Booklet Do Not wear or operate around MRI devices Remove and leave outside MRI room before entering Protected against water submersion IPX8 Pump tested to 3 6 meters 12 feet for 24 hours Catalog Number mw BEFORE YOU BEGIN The following symbols may be found on the CGM Sensor and Transmitter package labels These sym bols tell you about the proper and safe use of the CGM This table shows what each symbol means lt Use by Date Caution Consult Owner s Booklet Date of Manufacture A c sn Serial Number STERILE R Sterilized by Radiation Do Not Use if Package is Damaged Lot Number Catalog Number Two sided Temperature gt 8 XIV 5 X o ug X gt E Protected against water jets Protected against water submersion CGM tested to 2 4 Meters 8 feet for 24 hours Consult Owner s Booklet Manufacturer Humidity Limitation Shock Protection Type B Applied Part mw BEFORE YOU BEGIN
144. in Pump Record 1 indicates the most recent record Use the O O buttons to scroll to other records Record 23 Mar 2010 The screen displays the following 01 15PM Fill Cannula Record number Total 1 0U e Date of cannula fill e Time of cannula fill e Amount of cannula fill 4 When finished reviewing press to exit Review Mode 5 lt is highlighted Press to return to the HISTORY menu Suspend History Your pump displays the last 30 Suspend records 1 From the HISTORY menu select Suspend HISTORY The screen displays the following Bolus Record Total Daily Suspended Record number Dose TDD 23 Mar 2010 01 13PM Date and time pump delivery was suspended Resumed 23 Mar 2010 Date and time pump delivery was resumed 01 13PM 2 Scroll up to highlight the record field Press to activate Review Mode indicated by flashing cursor Record 1 indicates the most recent record Use the O O buttons to scroll to other records 4 When finished reviewing press to exit Review Mode 5 lt is highlighted Press to return to the HISTORY menu mum CHAPTER 7 HISTORY FEATURE Basal History Your pump keeps track of whenever there has been a change in a basal rate and will display the last 270 basal rate change records 1 From the HISTORY menu select Basal HISTORY The screen displays the following Tota Daily ci PEN Dose TDD 01 13PM Record number Ala
145. infusion set to the pump s insulin cartridge maximum total daily dose TDD delivery warning You can program your pump to alert you when combined basal and bolus insulin delivery will exceed a maximum daily amount you have set in your pump maximum two hour 2hr delivery warning You can program your pump to alert you when combined basal and bolus insulin delivery will exceed a maximum 2 hour amount you have set in your pump mmol L mmol L is the unit used to measure glucose levels It is the abbreviation for millimoles of glucose per liter of blood To convert mmol L to mg dL divide by 0 055 or multiply by 18 02 occlusion Occlusion means blockage The Animas Vibe Insulin 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 re start the pump o ring Both the cartridge and the battery cap contain an 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 radio frequency RF How CGM readings are sent from the Transmitter to the pump m APPENDIX A GLOSSARY mum RF range The allowable distance between the pump and CGM Sensor Transmitter for them to be able to communicate rise and fall alerts See CGM rise and fall aler
146. ing Press the button once to change the amount to match the suggested bolus Bolus Total amount Then use the O O buttons to adjust the amount if necessary When you have the desired delivery amount displayed press Q9 GB NOTE e Calculated total units will be rounded to the nearest 05 units e f the maximum bolus limit you set in Advanced Features is less than the suggested Total bolus amount on the Bolus Total screen the bolus amount entry field will change to that limit rather than the suggested Total amount when you press the button once 6 is highlighted If you wish to give a Normal DELIVERING Bolus press amp to deliver 2 250 Press any function button to cancel 7 If you wish to give a Combo Bolus scroll to the field and press to edit 8 Use the O O buttons to select bolus type Normal default or Combo Press Q9 9 is highlighted Press Q9 NOTE If you select the Combo Bolus option the Combo Bolus screen will be displayed See Combo Bolus pages 68 69 in this chapter for instructions on delivering the Combo Bolus me CHAPTER 10 USING ADVANCED FEATURES Animas Vibe Insulin Pump Adding a BG Correction Bolus to ezCarb The following example shows how to add a BG correction bolus to a carb bolus 1 On the ezCarb Home screen enter the number of carbs Press Q9
147. ion of the Animas Vibe System with respect to electromagnetic compatibility EMC Following this guidance will not guarantee faultless operation but should provide reasonable assurance of such The tables in this section are required by the EMC standard IEC 60601 1 2 Medical electrical systems need special precautions regarding electromagnetic compatibility EMC and need to be installed and put into service according to the EMC information provided in this Owner s Booklet Portable and mobile RF equipment can effect medical electrical systems Cables and accessories not specified for use with the Animas Vibe System by Animas are not authorized Use of such unauthorized cables or accessories may adversely impact safety performance and EMC increased emissions or decreased immunity Care should be taken if the Animas Vibe System is adjacent to or stacked upon other electrical equipment If such use is unavoidable it should be verified through observation that neither product is affected by the proximate use Guidance and Manufacturer s Declaration on Electromagnetic Emissions The Animas Vibe System is intended for use in the electromagnetic environment specified below The customer or the user of the Animas Vibe System should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance The Animas Vibe System uses RF energy only for RF emissions its internal funct
148. ion Therefore its RF emissions are Group 1 CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR 11 Harmonic emissions Not applicable IEC 61000 3 2 Voltage fluctuations flicker emissions Not applicable IEC 61000 3 3 uoneunuoJu je2Iuuoo e ueuojurew dD m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION m Guidance and Manufacturer s Declaration Electromagnetic Immunity The Animas Vibe System is intended for use in the electromagnetic environment specified below The customer or the user of the Animas Vibe System should assure that it is used in such an environment Immunity Test IEC 60601 Compliance Level Electromagnetic Environment Test Level Guidance Electrostatic 6 kV contact 8 kV contact Floors should be wood concrete discharge ESD 8 kV air 15 kV air or ceramic tile If floors are IEC 61000 4 2 pump covered with synthetic material IEC 60601 2 24 the relative humidity should be at least 30 6 kV contact 8 kV air CGM Transmitter Electrical fast 2 kV for power Not applicable Not applicable transient burst supply lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV line s to line s Not applicable Not applicable IEC 61000 4 5 2 kV line s to earth Voltage dips short lt 5 96 Ur Not applicable Not applicable interruptions and 695 96 dip in Ur voltage variations
149. ions Changing the Cartridge and Infusion Set Cartridges and infusion sets require replacement and are not to be reused Infusion sets should be replaced approximately every 2 3 days or as directed by your health care team Refer to the insulin labeling and follow the direction of your health care team for frequency of replacing the cartridge aqra GB A CAUTION 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 WARNING Cartridges are for single use only Re use of a cartridge can adversely affect product performance and can contribute to infection insulin contamination and under delivery of insulin me CHAPTER 3 GETTING YOUR PUMP READY mm Animas Vibe Insulin Pump LES 4 ms CHAPTER 4 USING THE NORMAL BOLUS FEATURE This chapter covers the basics of a Normal bolus which is used to cover your insulin needs Your pump also offers advanced bolus features See Chapter 9 in Section 1 pages 43 56 1 From the MAIN MENU select Bolus CGM Suspnd Resum History Basal Setup Prime Rewind Status Home NORMAL BOLUS NORMAL BOLUS Amount Amount 2 The cursor will flash over the amount field to indicate that it can be edited Use the O O buttons to enter desired bolus amount Press GB
150. ipment marked with the following symbol 2 uoneunuoJu je2Iuuoo II m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION m Maintenance amp Technical Information D Recommended separation distances between portable and mobile RF communications equipment and the Animas Vibe Insulin Pump The Animas Vibe System is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled The customer or user of the Animas Vibe System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Animas Vibe System as recommended below according to the maximum output power of the communications equipment Rated maximum Separation distance according to frequency of transmitter output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz of transmitter 3 5 yp 0 7 W 1 d 0 35 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all si
151. isted in the table below along with some suggested solutions You will need to wait 10 minutes once RF communication resumes for CGM readings to begin appearing again on your pump POSSIBLE CAUSE OF RF COMMUNICATION PROBLEMS SUGGESTED SOLUTION Your pump and CGM Sensor Transmitter are not within allowable RF range Make sure your pump and CGM Sensor Transmitter are within 3 6 meters 12 feet of each other Damp clothing Change to dry clothing Electric blankets Remove the blanket Waterbeds Switch to regular bed Nearby metallic objects Remove or move away from metallic objects High levels of electrical noise Move away from the source of the noise 155 uoneuuoJu je2Iuuoo e ueuojurew m CHAPTER 3 TROUBLESHOOTING GUIDELINES CGM Sensor Failures Errors Your CGM session may be interrupted or stopped before the end of a full 7 day period due to CGM Sensor failure or error CGM Sensor Failures The CGM Sensor Failure Warning see page 135 or CGM Data Failure Warning see page 137 will display sound and the CGM session will stop Call Customer Support or your local Animas distributor see page 187 for assistance before inserting a new CGM Sensor and starting a new CGM session CGM Sensor Errors The CGM Sensor Error O Error 1 Warning see page 136 will display sound There may be a CGM data gap during the period the CGM Sensor was not functioning prope
152. l pages 157 158 and contact your health care team 1 From the SETUP menu select Advanced Sick Days BG over 2 Scroll to the Setup Advanced Screen 9 mmol L Check ketones every 4 Hrs Check BG every 2 Hrs 3 Enter or review the guidelines as recommended by your health care team 1 s CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Alerts Warnings and Alarms Your pump has a progressive warnings and alarms safety system This means if you do not confirm the warning or alarm it will get progressively louder and change to a sweep tone with vibrate within one hour At the high volume stage if you do not confirm the warning or alarm the sweep tone will begin and will not stop until appropriate action is taken NOTE Your pump uses battery power to notify you of 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 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 If multiple alerts warnings or alarms occur simultaneously the pump wi
153. ld result in serious injury or death from hypoglycaemia CHAPTER 3 GETTING YOUR PUMP READY m Animas Vibe Insulin Pump 11 Make sure Prime is highlighted Press and hold the button until you see 5 drops of ACTIVE DONE insulin come out the end of your infusion set This di eda jud Bones means your tubing is primed The PRIMING ACTIVE while priming ee screen is displayed followed by the PRIMING DONE tubing 182U Remaining screen Insulin 182U NOTE The maximum Prime amount is 20U at a time The amount of Prime insulin displayed on the PRIMING DONE screen may differ from the amount displayed during the Priming procedure by 20 If additional priming is required select a second time from the ezPrime screen and repeat the steps for priming until you are sure 5 drops of insulin come out the end of your infusion set Refer to the nstructions for Use included with your infusion set for proper insertion guidelines See Selecting the Infusion Site and Inserting the Infusion Set page 19 in this chapter 12 From the ezPrime menu Cannula is highlighted Press the Q9 button The FILL CANNULA screen is displayed B Rewind im dd B Load Cart Amaun Thi i B Prime NOTE This step is not necessary for needle sets 13 Use the O O buttons to enter the amount of insulin needed to fill the cannula Refer to the Instructions for Use included with your infusion set for
154. le and Sensor Probe mw CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER Dexcom CGM C To remove the Needle keep holding pinching the Sensor Pod with one hand With your other hand place two fingers under the Collar Then pull the Collar back towards your thumb Stop when you hear 2 clicks or cannot pull back any more This step pulls the Needle back into the Applicator and keeps the Sensor Probe under your skin Remember to do this in the correct order push Plunger down then pull Collar up Pull back the Collar Retract the Needle 2 Squeeze the ribbed Release Tabs on the sides of the Sensor Pod to remove the Applicator When you squeeze the front Release Tabs the back tabs will widen allowing you to pull off the Applicator After this step only the Sensor Pod will be left on your body Make sure the Transmitter Latch is down against your body to remove the Applicator The used Applicator can be thrown in the trash Release the Applicator If you have any problems with insertion save the CGM Sensor and Applicator and contact Customer Support or your local Animas distributor 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 see page 187 5 Tape the Sensor Pod The Sensor Pod should stay attached on its own But if the patch is peeling up you can use medical tape such as Blenderm for extr
155. lf and your CGM session will continue to provide CGM readings Other problems may be serious enough to result in a CGM Sensor failure and your CGM session will terminate Your pump will notify you on the display if that happens Your pump will continue to deliver insulin if there is a CGM Sensor failure After pressing to confirm the Warning call Customer Support or your local Animas distributor for assistance 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 see page 187 116 mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mem Missing CGM Readings appears in place of current CGM reading Any time you see the symbol on either the CGM Data or CGM Trend screens your pump requires that you enter a fingerstick BG value for a calibration update or recalibration A CGM Warning screen will also appear to remind you to enter a fingerstick BG value Enter BG Confirm Follow the steps for entering a fingerstick BG value see page 106 After entering a fingerstick BG value a CGM reading should immediately appear on the display and CGM readings should resume being updated every 10 minutes If a CGM reading does not immediately appear follow any display prompts and refer to Chapter 10 in Section Il pages 127 140 to troubleshoot any warnings alarms or alerts W92 1 The symbol will remain on CGM Data and CGM T
156. ll be prompted on the display to decide if the BG value you just entered should be used to calibrate your CGM see Use BG Chapter 5 in Section Il pages 105 108 Select YES and press Q to usethis For CGM BG value for CGM calibration Calibration Must Be A NOTE Fingerstick This screen will appear only if you are in an active session If you decide to use the BG value for CGM calibration the value must be within 2 2 22 2 mmol L must be from a fingerstick BG test and must have been taken within the last 5 minutes Do Not use a BG test result from an alternative sampling site e g palm or forearm for CGM calibration The pump display may time out before you have had a chance to confirm the use of the BG value for CGM calibration In this case the BG value will not be used for CGM calibration mew CHAPTER 10 USING ADVANCED FEATURES m Animas Vibe Insulin Pump ezCarb Examples with the Feature Activated If the feature is activated your IOB amount will be displayed for reference on the ezCarb Bolus Total screen With the feature activated your suggested ezCarb total bolus amount will be as follows If your current BG is above your target range and your BG correction amount is greater than your IOB amount then your suggested total bolus amount will be your Carb correction amount plus your BG correction amount minus your IOB amount This is illustrated in example 2 that follows
157. ll display the most critical one first After confirming the condition with the highest priority the one currently displayed the alert alarm or warning with the next highest priority will be displayed until confirmed Each alert alarm and or warning must be confirmed separately until all simultaneous conditions have been confirmed Take special note of alerts alarms and or warnings that include messages about insulin delivery continuing or stopping particularly when they occur simultaneously on the pump It is possible to see a Deliveries continue message followed by a No delivery message Deliveries continue means insulin delivery is not impacted by the alert alarm and or warning that prompted the message No delivery means insulin delivery has stopped and will remain stopped until the problem that caused the alert alarm and or warning to appear is resolved Alerts are automatically displayed to remind you of a function that you have set or a condition that exists Warnings are triggered for a variety of reasons They require you to confirm the warning by pressing and or taking action to address the warning Alarms are triggered by several conditions require you to address the alarm by taking appropriate action in order to clear the alarm condition 2 Indicates that this alert warning or alarm can play a tune as the initial notification for medium and high volume settings
158. llowing items A letter from your health care team that explains the necessity of carrying insulin supplies and wearing a pump A prescription for insulin both rapid acting for your pump and the type recommended by your health care team in case you need to take insulin by injection Remember your 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 uoneunoJu je2Iuuoo e ueuojurew D 159 mew CHAPTER 5 LIFESTYLE ISSUES Maintenance amp Technical Information D e Emergency supplies listed in Before You Begin page XV e Accessible snacks Bottled water to prevent dehydration while flying Remember to check your BG frequently to distinguish between high BG dehydration and normal flight dehydration e The name of a referral health care team at your final destination in case of an emergency Also to consider when traveling e Pack your insulin carefully so that it is not exposed to extreme temperatures or temperature changes Refer to the instructions that came with your insulin for appropriate storage conditions e Pack your pump supplies in carry on luggage when traveling by air or train Do Not pack your supplies in checked luggage Contact your local airport administration or security office before traveling by air to obtain prescription medical supply carry on regulations e Your pump
159. lt your health care team before using your 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 health care team will give you specific training on programming and using your pump Use of Extended Bolus Combo Bolus ezCarb carb calculator Insulin on Board IOB and ezBG BG correction calculator all require input from your health care 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 Only your health care team can determine your Insulin to Carbohydrate ratios Insulin Sensitivity Factors ISFs BG Target ranges and duration of Insulin on Board IOB Treatment decisions should not be based on CGM results You must confirm your CGM results with results from a BG meter before making dosing decisions Basal rates that are too high or too low can adversely affect BG levels Work with your health care team to fine tune basal rates The way your body uses insulin can be affected by many things Contact your health care team about lifestyle changes such as starting stopping your exercise program or significant weight loss gain Your basal rates may
160. lucose Alerts let you know when your CGM readings fall outside the levels you set in the pump The Rise and Fall Rate of change Alerts let you know when your CGM readings are rising or falling faster than the limits you set in the pump You have the option to enable or disable these alerts and customize the levels limits based on your health care professional s recommendations see Chapter 2 in Section pages 87 94 In addition to the information CGM Data and CGM Trend screens these Alerts are another way of letting you know when your glucose levels may be getting dangerously high or low WARNING The CGM is not designed to replace a blood glucose meter The CGM must be used with a blood glucose meter Symptoms related to low or high blood glucose levels should not be ignored If you have symptoms of low or high glucose use your blood glucose meter to check the CGM results NOTE The CGM Alerts discussed here are separate from the LOW BG and HIGH BG Alerts that display sound on your pump when you enter a BG value below 3 9 mmol L or above 13 9 mmol L CGM Warning CGM Warning CGM Warning Glucose Glucose Glucose Glucose Level is Level is Level is Level is Above High Below Low Falling Too Rising Too User Limit User Limit Quickly Quickly zum High Glucose Alert Low Glucose Alert Fall Rate Rise Rate of change Alert of change Alert In these 4 instances insulin deliveries and your
161. m your BG meter in addition to the Trend Arrows to make an informed decision about your glucose management Color Key Red arrows or red CGM data points on the CGM Trend screens indicate your most recent CGM reading was at or above the High Glucose Alert level you set in your pump Green arrows or green CGM data points on the CGM Trend screens indicate your most recent CGM reading was between the High and Low Glucose Alert levels you set in your pump Blue arrows or blue CGM data points on the CGM Trend screens indicate your most recent CGM reading was at or below the Low Glucose Alert level you set in your pump m mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP Dexcom CGM Symbols That Might Appear in Place of your Current CGM Reading These symbols may appear in place of your current CGM reading on the CGM Data and CGM Trend screens Condition There is no active CGM session CGM Sensor was inserted within the last 30 minutes No CGM readings are available A CGM Sensor was inserted between 30 and 60 minutes ago No CGM readings are available A CGM Sensor was inserted between 60 and 90 minutes ago No CGM readings are available A CGM Sensor was inserted between 90 and 120 minutes ago No CGM readings are available Sensor Error Wait 15 minutes and then enter at least one fingerstick BG value into the pump to recalibrate CGM Sensor Error 1 Wait 1 hour and then enter at least one fi
162. may be prompted for another fingerstick BG value You may also be prompted for another fingerstick BG value during the 2 hour startup period Enter BG When prompted press to confirm the Warning and follow the steps for Confirm entering a BG value You will continue to be reminded to enter a valid BG value until the BG value is accepted for recalibration will appear on the CGM Data and CGM Trend screens in place of your current CGM reading until the BG value is accepted You may also choose to end the CGM session see Chapter 8 in Section Il pages 123 124 after repeated unsuccessful attempts at recalibration NOTE Do Not enter a BG value for CGM calibration if you see the 2 the CGM Data or CGM Trend screens on your pump see Chapter 6 in Section ll pages 109 118 This means the pump and CGM Transmitter Sensor are not communicating Refer to Chapter 3 in Section Ill pages 147 156 for troubleshooting problems with CGM calibration Any BG value you enter when using the ezBG or ezCarb feature on your pump can be used for calibration update recalibration When prompted to choose if you want the BG value used for CGM calibration select Yes and press Q9 NSO 107 me CHAPTER 5 CGM CALIBRATION mem CGM H 108 6 m CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP Your fingerstick BG meter only gives you a BG level at one point in time like a still picture
163. may require treatment with insulin Gestational diabetes usually ends when the baby is born but many mothers who experience gestational diabetes may later develop Type 2 diabetes glucagon Glucagon is a hormone produced by the alpha cells in the pancreas It causes BG levels to rise 178 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 and other fluids throughout the body hyperglycaemia Hyperglycaemia is also known as high blood glucose BG It occurs when BG levels rise above 10 0 mmol L and the body does not have enough or cannot use insulin 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 BG It occurs when BG levels drop to below 3 9 mmol L This can happen if a person with diabetes has taken too much insulin or has exercised more than usual Symptoms of hypoglycaemia 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 Hypoglycaemia can occur even
164. multiple basal programs in the Setup Advanced menu all 4 basal program options will be displayed as shown on screen example below right BASAL MENU BASAL MENU 1 From the BASAL MENU scroll to Temp Press Total 0 00 Total 0 000 A1 WEEKDAY A1 WEEKDAY 2 other 3 weekend 4 exercise m CHAPTER 5 USING BASAL PROGRAM FEATURES 2 The Change field will flash to indicate Edit mode Use the buttons to enter the TEMP BASAL TEMP BASAL percentage change desired Press the button to exit Edit mode Duration Duration Change Change A1 WEEKDAY TEMP BASAL Change 40 Duration The Duration field is highlighted Press to activate Edit mode Use the buttons to enter the duration desired Press Q9 to exit Edit mode Animas Vibe Insulin Pump L A CAUTION The lowest basal delivery amount possible is 0 025U Hr When you set a negative temporary basal rate your pump will beep and ar Temp Active display an Alert screen to remind you of the minimum delivery limit Minim tn This screen will display once for 4 seconds and give one audible alert Basal rate if you turned on Alert sounds in Setup Your pump will not deliver any limited to temporary basal set below 0 025 U Hr Any temporary basal rate set 0 025U Hr below 0 025 U Hr will automatically be re set to 0 025 U Hr If you would like to deliver a temp basal amount less than 0 025
165. n If you experience symptoms of hypoglyczemia you should immediately eat a quick acting carbohydrate glucose tablets juice or hard candy e Do Not rely on CGM readings if you experience symptoms of hypoglycamia If you suspect hypoglycamia obtain a fingerstick value with your BG meter If your BG is abnormally low Do Not attempt to program your pump yourself Get help e Treat hypoglyczemia immediately Rule of 15 1 Consume 15 grams of quick acting carbohydrate 2 Wait 15 minutes 3 Recheck BG with BG meter 4 If BG is 3 9 mmol L repeat above Troubleshooting hypoglycemia INSULIN PUMP POSSIBLE CAUSE OF LOW BG SUGGESTED SOLUTION Basal rate programmed Check times and rates remember to review basal programs incorrectly when making any changes Clock time incorrect Reset clock to current time being careful to check AM amp PM Disconnect from pump Call Customer Support or your local Animas distributor 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 see page 187 Pump exposed to MRI Walsh JR amp Roberts R Pumping Insulin 2006 San Diego Torrey Pine Press 147 uoneunoJu je2Iuuoo D me CHAPTER 3 TROUBLESHOOTING GUIDELINES sm Maintenance amp Technical Information D POSSIBLE CAUSE OF LOW BG Bolus too large Troubleshooting hypoglyc
166. n or treatment decisions Insulin dosing decisions should not be based solely on results from the CGM Your pump and pump accessories include small component pieces that could pose a choking hazard for small children Radiology Equipment Your pump has been designed to operate in the presence of common sources of electrostatic and electromagnetic interference such as store security systems However like all portable electronic devices your pump should not be exposed to very strong electromagnetic fields such as in Magnetic Resonance Imaging MRI RF welders or magnets used to lift automobiles Very strong magnetic fields such as in an MRI can re magnetize the portion of the motor that regulates insulin delivery If you plan to undergo an MRI remove your pump and CGM Transmitter Sensor beforehand and then keep them outside the room during the procedure mw BEFORE YOU BEGIN Guidelines Involving Use of the Animas Vibe System During Medical Procedures A CAUTION Certain medical procedures involve the use of energy fields e g ionizing radiation magnetic radiation that can damage the Animas Vibe System Device users must NEVER expose the pump CGM Transmitter Sensor and certain infusion sets to these types of energy fields ALWAYS remove the pump and CGM Transmitter Sensor before entering the room where one of these procedures will be performed Medical Procedure Device User Patient or HCP administering the proc
167. n 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 Change infusion set and site Check needle cannula insulin looks pink or red angle at new 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 Do Not tighten cartridge cap while the infusion set is connected to your body Redness tenderness lumps Change infusion set and site use clean technique Treat c itching warmth discharge old site for infection if necessary Consult health care 9 team Cartridge Reused Do Not reuse cartridge Cartridge is for single use only 2 O 5 c 152 me CHAPTER 3 TROUBLESHOOTING GUIDELINES mum Problems with CGM Sensor Insertion Problems can occur during CGM Sensor insertion and in keeping the Sensor Pod at
168. n stops Beeps Vib CGM and pump are having a communication problem Displayed each time pump is awakened until confirmed Press to confirm Call Customer Support or your local Animas distributor for assistance 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 see page 187 User selected under CGM Setup menu options every 3 minutes until confirmed No progression Warning CGM Transmitter Low Battery Beeps Vib CGM Transmitter battery power is low Warning may also be caused by low temperatures Insulin deliveries continue CGM continues but with possible data gaps Displayed each time the pump is awakened until confirmed Press to confirm Try moving to a warmer area if you feel the temperature may be too low Replace the CGM Transmitter if the Warning continues to appear User selected under CGM Setup menu options every 3 minutes until confirmed No progression 137 CGM Failure Insulin Delivery Continues Call Service XXX XXXXXXXX XXXXXXXXXX ZI N52 Replace CGM Transmitter Low Battery mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning Glucose Level Below 3 1 mmol L Glucose Level is Below 3 1 mmol L effect Insulin deliveries continue CGM continues ETUMER EL Last CGM reading at or below 3 1 mmol L fixed limit set
169. n this chapter See Chapter 10 in Section 1 pages 57 72 for information on using the ezBG and ezCarb features on your pump Before you begin using the ezBG and ezCarb features on your pump take note how your pump determines the difference between your current BG and the BG Target range value NOTE The BG Targets discussed here are different than the Low and High Glucose Alerts that apply only to CGM readings See Chapter 2 in Section Il pages 87 94 for more information on CGM Alerts m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION mm If you set a BG Target range then the difference between your current BG and your BG Target range is determined as follows e f your current BG is above your BG Target range your pump subtracts the midpoint of your BG Target range from your current BG For example if you set a BG Target range of 5 6 7 8 mmol L midpoint is 6 7 mmol L and your current BG is 8 9 mmol L then the resulting difference is 8 9 mmol L 6 7 mmol L 2 2 mmol L e f your current BG is below your BG Target range your pump subtracts the midpoint of your BG Target range from your current BG The resulting difference will be a negative number For example if you set a BG Target range of 5 6 7 8 mmol L midpoint is 6 7 mmol L and your current BG is 4 5 mmol L then the resulting difference is 4 5 mmol L 6 7 mmol L 2 2 mmol L e f your current BG is within your BG Target range then the resulting difference is a
170. n to Suspnd Resum and press Basal Setup Prime Rewind Pump Suspended at 2 27PM 2 Oct 2010 2 Resume is highlighted Press Q9 ee 3 The Home screen is displayed to show you that your pump is no longer in Suspend mode Your previously active basal program is automatically resumed Basal Rate 0 025U Hr Insulin 105U Status 7 Your pump stores important records for your review You can access your pump s history and view it directly on your pump screen or you can use the Diasend Web based Diabetes Management System to track review and analyze pump history on your computer Visit www diasend com animas for more information To view CGM History see Chapter 7 in Section pages 119 122 Your pump stores basal rates boluses alarms and settings Your pump stores these records indefinitely even when batteries are removed From the MAIN MENU select History The HISTORY menu is displayed Prime Rewind Status Home GB Bolus History Your pump displays the last 500 Bolus records 1 From the HISTORY menu select Bolus The screen displays the following e Bolus Record number Date of bolus HISTORY Time of bolus Total Daily 23 Mar 2010 Dose TDD 1 13PM e Type of bolus delivered Alarm NORMAL Prime 2 80U of 2 80U o Normal Suspend COMPLETED o Combo Basal o Audio e Amount of bolus programmed and deli
171. n to go to the SETUP SOUND screen Use the O O buttons to scroll to your selection Press the Q9 button 4 The cursor will flash to indicate you can edit the selection Use buttons to change to desired setting Press the button to confirm SETUP SOUND SETUP SOUND L Bolus Alert CGM Time Date Suspnd Resum Reminder Vib History Basal Warning M Advanced Prime Rewind Alarm Status Home 5 Repeat for remaining selections 6 Scroll to gt to access second SETUP SOUND menu or scroll to when finished to return to the Home screen m CHAPTER 3 GETTING YOUR PUMP READY mm The Cartridge Filling the Cartridge Refer to the nstructions for Use included with your cartridges Connecting the Tubing to the Cartridge To complete this section you will need the following Filled Animas 2 0 mL Cartridge 200 unit 2ml Infusion set compatible standard Luer lock and insulin compatible tubing with your Animas Vibe Insulin Pump A WARNING The efficacy of your pump cannot be guaranteed if cartridges other than those manufactured by Animas Corporation are used Only infusion sets marketed for use with insulin infusion pumps using insulin compatible tubing and with a standard Luer lock can be used with your Animas Vibe Insulin Pump The efficacy of your pump cannot be guaranteed if other types of infusion sets are used If you are unsure about whether your infusion
172. nd CGM Trend screens and CGM data points readings on the CGM Trend screens Trend Arrows These arrows indicate whether your glucose is rising or falling and at what rate Symbol Condition Rapidly rising Your CGM glucose readings are rising more than 0 17 mmol L each i minute Rising Your CGM glucose readings are rising 0 11 0 17 mmol L each minute NEN Slowly rising Your CGM glucose readings are rising 0 06 0 11 mmol L each minute A ES Constant Your CGM glucose readings are steady not increasing decreasing more than 0 06 mmol L each minute Slowly falling Your CGM glucose readings are falling 0 06 0 11 mmol L each minute Falling Your CGM glucose readings are falling 0 11 0 17 mmol L each minute N minute No No Rate of Change Information The CGM cannot always calculate how fast your CGM arrow s glucose readings are rising or falling NSO NOTE e Trend Arrows do not appear when CGM readings are missing on the CGM Data and CGM Trend screens see Missing CGM Readings pages 115 117 in this chapter e f the Trend Arrows are missing but you are concerned that your BG level may be rising or falling take a fingerstick BG test to check your level It is important to use the Trend Arrow information in conjunction with the CGM Trend screen graphs Do Not take action based on the Trend Arrow information only Use the information on the CGM Trend screen graph and results fro
173. need to be modified Do Not stop using your pump if you are ill unless instructed to do so by your health care provider Even when you are sick your body still needs insulin See Chapter 4 in Section pages 157 158 When you first start using the Audio Bolus feature always look at the display screen to confirm correct programming until you are comfortable using this feature 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 health care team Amusement Parks Very powerful electromagnets are sometimes used on free fall amusement park rides 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 your pump while on roller coaster rides A Aircraft without Cabin Pressurization If flying in aircraft without cabin pressurization or flying in aircraft used for aerobatics or combat simulation pressurized or not disconnect NOT suspend pump m BEFORE YOU BEGIN A PRECAUTIONS continued e Before Bedtime Plan infusion set changes at meals or one to two hours before bedtime If a change is needed at bedtime then check BG in one to two hours Always ch
174. nge Alert will not display sound on the pump CHAPTER 2 CGM SETTINGS Dexcom CGM m CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER sm To use the CGM in conjunction with your Animas Vibe Insulin Pump you will need a CGM Sensor and Transmitter You will also need a BG meter and test strips for calibration and to make all treatment decisions Once inserted and calibrated the CGM Sensor will continuously measure and display your glucose readings for up to 7 days 166 hours after the 2 hour startup period This chapter will show you how to insert the CGM Sensor and attach the CGM Transmitter CGM Sensor Overview The CGM Sensor is a device that continuously measures your glucose levels You will use a BG meter to calibrate your glucose readings measured by the CGM Sensor The CGM Transmitter collects the CGM Sensor readings and sends them to the pump using wireless radio frequency RF technology This happens every 5 minutes for up to 7 days The CGM Sensor unit has an Applicator Needle Sensor plastic housing Sensor Probe and Sensor Pod The Applicator includes a Safety Lock Transmitter Key to keep the Needle in place until you are ready to insert After taking off the Safety Lock Transmitter Key you will insert the Sensor Probe just beneath the skin subcutaneous tissue of your belly using a small Needle inside the Applicator The Needle is inserted just under the skin at an angle and
175. ngerstick BG value into the pump to recalibrate Fingerstick BG values needed for calibration The CGM reading cannot be displayed at this time There was no communication between the pump and CGM Transmitter within the last 5 minutes Most recent CGM reading was higher than 22 2 mmol L Most recent CGM reading was lower than 2 2 mmol L 112 mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP Accessing the CGM Data and CGM Trend screens from the CGM Menu 1 From the MAIN MENU screen scroll to CGM and press Suspnd Resum History Basal Setup Prime Rewind Status Home 2 Scroll to Trend Graph and press Trend Graph Start Stop History Setup The last CGM Trend screen or Data screen if you have just awakened the pump display will be displayed Use the O O buttons to scroll through the 1 hr 3 hr 6 hr 12 hr and 24 hr CGM Trend screens and then the CGM Data screen CGM readings data points on CGM Trend screens track from right most recent to left oldest for the time period covered The CGM Trend screens show you where your glucose levels have been and where your glucose levels are headed To return to the CGM Menu screen press while viewing the CGM Data screen or any CGM Trend screen W99 7 RA 0 _2 25U m CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mem Dexcom CGM CGM High Low and Rise Fall Rate Alerts The High and Low G
176. ning CGM Session Expires In 30 Minutes Current CGM Session has 30 minutes left until 7 day CGM Session Cause siod end Expires In 00 30 Insulin deliveries continue CGM continues Confirm E Displayed each time pump is awakened until confirmed Each time the pump is awakened the Message screen will display the actual time remaining rather than the original 30 minutes displayed when the Warning first appeared Press to confirm Replace CGM Sensor in 30 minutes and start new CGM session User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression 199 1 Warning CGM Session Expired Sensor Current CGM Session has expired Expired CGM Session effect Insulin deliveries continue CGM session ends Ended Message Displayed each time pump is awakened until confirmed Press to confirm Replace CGM Sensor and start new session User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression 131 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning Glucose Level Above High Glucose Alert Level Glucose Last CGM reading at or above limit set in pump Level is Above High J effect Insulin deliveries continue CGM continues user Limit Confirm Displayed each time pump is awakened until confirmed Action Press to confirm Check BG wi
177. o o Release Tab NOTE Always check the expiration date on the CGM Sensor packaging before opening the CGM Sensor for use Never use expired CGM Sensors The expiration date format is YYYY MM DD Sensor Pod 3 NSO 1 Remove the CGM Sensor from its packaging A PRECAUTION The CGM Sensor is sterile in its unopened undamaged package Do Not use any CGM Sensor if its sterile package has been previously damaged or opened Carefully remove the CGM Sensor from its packaging Look closely at the CGM Sensor to make sure itis not damaged The Applicator is a single use disposable unit The Safety Lock Transmitter Key prevents you from accidentally releasing the Needle before you are ready m CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER mem Dexcom CGM 2 Choose an insertion site PRECAUTIONS e Establish a rotation schedule for choosing each new CGM Sensor location Avoid locations that are constrained by clothing accessories or subjected to rigorous movement during exercise Avoid injecting insulin or placing an insulin pump infusion set within 7 6 centimeters 3 inches of a CGM Sensor Choose a site on a fatty area of your belly to place the CGM Sensor You can choose a site above or below your belt line The best areas to insert your CGM Sensor are usually flat pinchable and free from where rubbing can occur i e pant line seatbelts Avoid areas with scarring
178. of this Owner s Booklet can be viewed or downloaded by visiting www Animas com The website also provides information about educational programs in you area frequently asked questions and answers tips and practice skills for diabetes management and other valuable tools Your Animas Vibe Insulin Pump can be used with or without Dexcom CGM components The Owner s Booklet is set up in Sections so that you can first learn about using your pump as a stand alone device Section I and then learn about using your pump with Dexcom CGM Section II Of course you may still have questions If you do Customer Support or your local Animas distributor will be happy to answer your call 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 see page 187 You can also obtain information at www Animas com TABLE OF CONTENTS BEFORE YOU BEGIN SECTION 1 ANIMAS VIBE INSULIN PUMP CHAPTER 1 Insulin Pump Overview 1 CHAPTER 2 Introduction to your Animas Vibe Insulin Pump 3 CHAPTER 3 Getting your pump ready 9 CHAPTER 4 Using the Normal Bolus feature 21 CHAPTER 5 Using Basal Program features 23 CHAPTER 6 Suspend Resume feature 31 CHAPTER 7 History feature 33 CHAPTER 8 Status feature 39 CHAPTER 9 Advanced features Setup and activation 43 CHAPTER 10 Using Advanced features 97 CHAPTER 11 Pump safety system and alarms 73 SECTION DEXCOM
179. ollow on pages 111 112 for the meaning of the various symbols that might appear on the CGM Trend screen During an active CGM session you can access the CGM Trend screen by pressing the Contrast button CGM shortcut Q to wake up the pump Example CGM Data Screen Current Time Trend Arrow Insulin on 12 34PM dne Current amount CGM 7 9 displayed reading mmol L only 18108 feature is IOB 5 54 activated on the pump Example CGM Trend Screen Current GM Tend reading Current Time Graph Time Period CGM High Glucose readings Alert Level over the appears when this Alert is enabled on a the pump Low Glucose Alert Level Most recent appears when this CGM reading Alert is enabled on the pump When the pump is in sleep mode pressing the Contrast button CGM shortcut will awaken the pump to the CGM Data or Trend screen last displayed when the pump went to sleep Trend Arrows on CGM Data and CGM Trend screens and CGM data points readings on the CGM Trend screen are color coded An explanation of the Trend Arrows and the color coding appears on the next page t A symbol may appear in place of your current CGM reading on CGM Data and CGM Trend screens An explanation of these symbols appears on page 112 110 mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mum CGM Data and CGM Trend Screen Arrows and Color Key NOTE The color key applies to the Trend Arrows on the CGM Data a
180. ombo Bolus Reminders All Advanced Bolus features are activated in the Setup Advanced Menu See Chapter 9 in Section 1 pages 43 56 When the Advanced Bolus features and Reminders are activated the full BOLUS MENU is displayed GB A WARNING Be sure to review all the values used in bolus calculations to make sure they are correct You may always adjust the insulin units up or down before you decide to administer your bolus If you dose an insulin amount that is too high or too low this may result in a hypoglycamic or hyperglyczmic event Please discuss the bolus calculator feature and all relevant personal settings with your health care professional before using the calculator for the first time NOTE When using the ezCarb or ezBG feature to calculate a suggested total bolus amount that amount will be set to 0 00U whenever the calculation results in a negative number ezCarb This feature allows you to enter the number of carbs eaten Your pump will then automatically calculate your bolus dose based on your ratio ISF and BG Target for the current time stored in the pump Consult your health care team for your personal ratios ISFs and BG Target ranges See Chapter 9 in Section 1 pages 43 56 If the feature is activated your pump will take IOB amounts into consideration when calculating a suggested bolus amount If the feature is not activated on you
181. ome and press mw CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Setup Advanced Screen 8 Insulin on Board IOB Setting The Insulin on Board IOB feature activated and set by you helps you calculate how much insulin might still be active in your body from a previous bolus dose The actual amount of insulin left in your body is determined by the rate at which your body uses insulin your infusion site your activity level and other factors Your pump uses a curvilinear algorithm that mimics the way insulin is metabolized to track IOB The IOB setting is important as IOB amounts are taken into consideration when using the ezBG and ezCarb features on your pump to calculate suggested bolus amounts see Chapter 10 in Section 1 pages 57 72 IOB amounts apply only if the feature has been activated on your pump and you are using either the ezBG or ezCarb features to calculate a suggested bolus amount In certain situations your pump will calculate a reduced suggested total bolus amount to account for any IOB IOB when using the ezCarb feature The ezCarb Bolus Total screen will display a carb correction amount a BG correction amount your amount if the feature is activated and a suggested total bolus amount GB NOTE The displayed carb correction BG correction and IOB amounts if the feature is activated and the resulting total bolus amount are for reference only The
182. or Pump sounds may be set to e High Alert e Vibrate Vib only x e Low Alert Low Volume L beep and vibrate S e Rise Rate e Medium Volume M beep and vibrate S e Fall Rate High Volume and vibrate default setting z e Transmitter Out of Range e Other alerts NOTE Your pump does not have the same progressive warnings and alarms safety system for CGM functions as it does for insulin delivery functions 1 the MAIN MENU screen scroll to CGM and press Q Suspnd Resum History Basal Setup Prime Rewind CtGMMenu 2 Scroll to Setup and press BG Cal Trend Graph Start Stop History m CHAPTER 2 CGM SETTINGS Dexcom CGM Setup Scroll to Sounds on the CGM Setup screen and press High Alert Low Alert Rise Rate Fall Rate Out of Range Transmitter CGM Menu IUE 4 The High Alert field will be highlighted on the CGM Warning Sounds High Alert screen Press so that the highlight is flashing Use the and buttons to Low Alert select the desired sound for this alert Press Rise Rate Fall Rate Range Other CGM Setup 5 Repeat step 4 for the remaining alerts Low Alert Rise Rate Fall Rate Out of Range Other 6 When you are finished scroll to CGM Setup and press to return to the CGM Setup screen Setting CGM Alert Values Limits You can enable disable alerts and set
183. ormal Bolus Sounds in Setup If you wish to cancel the Audio Bolus press any function button If you cancel a bolus delivery after you have activated it the screen at right will be displayed See Chapter 11 in Section 1 pages 73 84 DELIVERING 3 00 Press any function button to cancel Bolus delivery canceled by user button press Delivered 2 00U of 3 00U IHE NOTE If during a bolus delivery your low cartridge level is reached your 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 The maximum number of Audio Bolus button presses is 20 Therefore if you have set the step size to 0 10 the maximum audio bolus amount is 2U If you have set the step size at 0 5 the maximum audio bolus amount is 10U and if your step size is 1 0U the maximum audio bolus amount is 20U With a 5 0U step size the maximum cannot be greater than 35U which is the maximum amount for any type of bolus m CHAPTER 10 USING ADVANCED FEATURES ezBolus NORMAL BOLUS ezBolus is a one button shortcut to the Normal Bolus screen whenever the Audio Bolus feature is not activated Amount 1 Press the black button on the right side of your pump once The Normal Bolus screen is displayed Program a Normal Bolus as usual Advanced Bolus Features ezCarb e ezBG BOLUS MENU e Combo Bolus ezCarb ezBG e Reminders C
184. our basal rates and your health care 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 9 in Section pages 43 56 Audio Bolus ezBolus Button The Audio Bolus ezBolus button on the right side of your pump serves two purposes If you activate the Audio Bolus feature it 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 with 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 ezBolus page 59 in this chapter ETT 1 A CAUTION 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 9 in Section pages 43 56 2 The Audio Bolus button is the soft rubber button on the end of your pump Press it once Your pump will beep or vibrate to indicate you have accessed Audio Bolus mode as well as indicate the step size you have set up The number of beeps or vibrate pulses reminds you ofthe step size you have set 1 beep or vibration pulse indicates 0 1U step size 2
185. outside of the adhesive patch to make sure it is flat Pressing the patch to remove any wrinkles should help it stick better e Press firmly over the entire patch area d Hold on to the Applicator Then pull the Safety Lock Transmitter Key straight out away from the Applicator in the direction the arrow shows below Remove the Safety Lock Transmitter Key NOTE The Safety Lock also serves as the Transmitter Key that is used later for CGM Transmitter removal Keep this piece to help you remove the CGM Transmitter at the end of a CGM session When your CGM session is over follow the steps in Chapter 9 in Section II pages 125 126 to remove the CGM Transmitter 4 Insert the CGM Sensor 1 Once you have placed the Applicator on your belly and removed the Safety Lock Transmitter Key you are ready to insert the CGM Sensor Follow the next 4 steps a d to successfully insert your CGM Sensor Hold down the Sensor Pod with one hand or it may help to pinch up on your skin where the Sensor Pod is placed With your other hand place two fingers above the Collar on the barrel of the Applicator b Place your thumb on the Plunger Push the Plunger down completely This action inserts the Needle and Sensor Probe under your skin When you are pushing down on the Plunger Do Not pull back on the Collar E d CLICK Push down the Plunger Insert the Need
186. ove to a shady area for best visibility While the pump is in sleep mode pressing the contrast button CGM shortcut will awaken the pump to one of the CGM Data or CGM Trend screens see Chapter 6 in Section Il pages 109 118 m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION Setup Advanced Screen 5 Auto OFF Feature You may program your pump to automatically suspend basal delivery and sound an alarm if no pump buttons are pressed in a user selected number of hours This feature can be used as a safeguard in case the user is unconscious If the alarm is displayed sounds it means all insulin delivery has stopped and you will need to disconnect the pump and re prime See page 83 for more information on the AUTO OFF Alarm A CAUTION If insulin delivery is suspended because the AUTO OFF Alarm has sounded displayed your CGM session will remain active but CGM readings will not be recorded or displayed As soon as insulin delivery resumes CGM readings will start recording and displaying again This screen allows you to turn the feature on and set the time period for checking if there have been button presses AUTO OFF Enable OFF 1 From the SETUP ADV 5 screen scroll to the desired field When enabled suspendin 12 if no buttons 3 Use the buttons to change to desired setting are pressed Press when setting is made 2 Press to change to flashing cursor for Edit mode
187. over the white adhesive patch of the Sensor Pod but Do Not place the tape over the CGM Transmitter or the plastic parts of the Sensor Pod 153 uoneunuoJu je2Iuuoo e ueuojurew II m CHAPTER 3 TROUBLESHOOTING GUIDELINES Problems with CGM Calibration Recalibration Your CGM requires calibration with fingerstick BG values at various times After entering a BG value s into your pump you may still be prompted to enter another BG value s CGM CALIBRATION ISSUE SUGGESTED SOLUTION Repeat prompts to enter BG You must enter 2 separate fingerstick BG values when values during startup calibration prompted at the end of the 2 hour startup period BG values must be within 2 2 22 2 mmol L and must have been taken within the last 5 minutes e You may continue to be reminded to enter another BG value s if one or both of the BG values you have entered is are not accepted The reminder will re appear until both BG values are accepted and startup calibration is successful Repeat prompts to enter BG You must enter at least one fingerstick BG value every values during calibration update 12 hours for the calibration update recalibration BG values must be within 2 2 22 2 mmol L and must have been taken within the last 5 minutes You may continue to be reminded to enter another BG value s if the one you entered is not accepted The reminder will re appear until the BG value is accepted and calibration u
188. owers BG levels In type 1 diabetes mellitus the beta cells are destroyed so the body can no longer produce insulin blood glucose BG levels BG levels are the measure of how much glucose sugar is in the blood The normal level is about 3 9 6 1 mmol L blood glucose BG meter Any commercially available BG meter can be used with your Animas Vibe System blood glucose BG value A fingerstick blood glucose test result taken with your commercially available BG meter bolus A bolus is the amount of insulin delivered at one time usually before a meal or when BG 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 calibration See CGM calibration CGM calibration This is when you enter fingerstick BG values into the pump for initial startup period and at least once every 12 hours thereafter Calibrations are needed for your Animas Vibe System to display continuous glucose readings and trend information Do Not use alternative site testing for CGM calibration CGM data gaps This can happen when the pump does not display a CGM reading that is sent from the Transmitter Symbols may appear instead of a CGM reading to let you know that the pump cannot display a reading CGM reading The continuous glucose monitoring value sent to your pump every 5 minutes C
189. pdate recalibration is successful Continued prompts to enter BG Your pump and CGM Sensor Transmitter may not be values even after following all communicating Make sure the devices are within RF instructions range Check to see if the or symbol appears in place of your current CGM reading on the CGM Data or Trend screen Do Not enter fingerstick BG values for startup calibration or calibration update recalibration if 2 or appears Wait 10 minutes to see if the devices start communicating and then enter a new fingerstick BG value BG values must be within 2 2 22 2 mmol L and must have been taken within the last 5 minutes If your pump and CGM Sensor Transmitter are communicating and you continue to be prompted for additional fingerstick BG values contact Customer Support or your local Animas distributor see page 187 for assistance Maintenance amp Technical Information D 154 m CHAPTER 3 TROUBLESHOOTING GUIDELINES Problems with RF communication Certain conditions may cause RF communication between your pump and CGM Sensor Transmitter to be lost or interrupted When RF communication is lost or interrupted or will appear instead of your current CGM reading on the CGM Data and Trend screens If your pump and CGM Sensor Transmitter are not within RF range the Transmitter Out of Range Warning may also display sound see page 134 The most common causes for RF communication to be lost or interrupted are l
190. programmed to confirm the VERIFY screen 0 025U Hr Insulin 105U 9 To change the battery type highlight the Battery field and press to Status Menu activate Edit mode indicated by flashing cursor 10 Use the O O buttons to change battery type and press to confirm and exit Edit Mode Your active basal NOTE program The correct battery type must be selected in order for your battery lif IS empty ery type must be selecte e your battery life 0 000U Hr indicator to be accurate Lith Lithium Alkl Alkaline e It is important to have the correct current date and time set in your pump If the pump loses the date and time setting due to the battery being removed for an extended period you will not be able to go to the Home Screen until you edit and confirm the settings on the Verify Screen Confirm Basal Menu aqra GB 11 Scroll to Confirm and press Qj The Home screen is displayed NOTE Until you have programmed a basal rate the Alert screen shown here will appear when your pump is awakened Simply scroll to Confirm and press to move past this Alert screen 12 Each time you change the battery a full Prime Rewind sequence is required see Priming your Pump and Infusion Set pages 16 18 in this chapter You do not have to remove your cartridge if the battery change is being done without a cartridge change Skip the Fill Cannula step unless you
191. r with diabetes The Animas Vibe System is intended for use by patients at home and in health care facilities The Animas Vibe System is indicated for use as an adjunctive device to complement not replace information obtained from standard home glucose monitoring devices The Animas Vibe System aids in the detection of episodes of hyperglycaemia and hypoglycemia facilitating both acute and long term therapy adjustments which may minimize these excursions Interpretation of the Dexcom CGM results should be based on the trends and patterns seen with several sequential readings over time mw BEFORE YOU BEGIN mm Warnings Precautions and Important Safety Information about your Animas Vibe System Read the entire Section and Section Il of this Owner s Booklet before using your Animas Vibe System If you do not understand something or have any questions ask your health care team Warnings Precautions Cautions Contraindications and other important Safety information about your Animas Vibe System follows below Be sure to read the information carefully WARNINGS Check with your health care provider regarding your individual training needs Do Not attempt to connect to your pump before you have been trained on your pump Incorrect use of your pump failure to follow the instructions in this Owner s Booklet or improper inadequate self care and troubleshooting techniques can lead to death or serious injury I
192. r Life Up to 7 days Fingerstick test with commercially available BG meter Calibration Range 2 2 22 2 mmol L 40 400 mg dL 95 Operational Conditions Humidity Maximum 95 Relative A desir Calibration Storage Condition Room Temperature IPX 5 water resistance to jetting water Moisture Protection IPX 8 continuous submersion to a depth of 2 4 meters 8 feet for 24 hours Sterilization Sterile by electron beam 174 Maintenance amp Technical Information D mw CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION m CGM Transmitter Length 3 8 centimeters 1 5 inches Width 2 3 centimeters 0 9 inches Thickness 1 3 centimeters 0 5 inches Dimensions including Sensor Pod Weight including Sensor Pod Communication Range 3 6 meters 12 feet Frequency Range 2 425 2 477 GHz Power Supply Silver Oxide Batteries Operational Temperature 10 42 C 50 108 Conditions Humidity Maximum 9596 Relative 10 0 grams 0 4 ounces Storage Conditions 5 water resistance to jetting water IPX 8 continuous submersion to a depth of 2 4 meters 8 feet for 24 hours Temperature 2 45 C 36 113 Moisture Protection uoneunoJu e ueuojurew D 175 me CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION Performance Characteristics PARAMETER PERFORMANCE CHARACTERISTICS Frequency Allocation
193. r hour Every third hour consume 240 ml 8 3 ounces of a sodium rich liquid such as bouillon You need to consume 150 200 grams of carbohydrates daily If ketones are moderate contact your health care team Develop a sick plan with your health care team prior to illness Mensing C The Art and Science of Diabetes Self Management Education 2006 Chicago American Association of Diabetes Educators uoneunoJu je2Iuuoo e ueuojurew D 157 me CHAPTER 4 SICK DAY GUIDELINES 158 dD je2Iuuoo m CHAPTER 5 LIFESTYLE ISSUES 5 Exercise and Sports There are many options for wearing your pump during exercise and sports activities During low contact sport activities such as walking biking or aerobics your 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 your pump can be disconnected for up to one hour Always follow your health care 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 BG levels Swimming Your pump is tested for immersion in water to a depth of 3 6 meters 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
194. r pump dashes will appear instead of a number in the field The following pages provide examples of how to use the ezCarb feature to calculate a suggested bolus amount to cover a set number of carbs and reduce a high BG The first example shows how to calculate a carb bolus The second example shows how to add a BG correction bolus to a carb bolus NOTE Carb amounts you enter with the ezCarb feature will be stored in the pump along with insulin delivery data You can use Diasend Web based Diabetes Management System to track review and analyze pump carb and insulin data on your computer Visit www diasend com animas for more information me CHAPTER 10 USING ADVANCED FEATURES Animas Vibe Insulin Pump Calculating an ezCarb Bolus 1 From the BOLUS MENU scroll to ezCarb Press The ezCarb Home BOLUS MENU screen is displayed ezBG Combo Bolus Reminders 2 The cursor will flash on the Carbs field to indicate that you can edit the total number of carbs eaten Use the Q buttons to enter the number of Carbs ELIg carbs Press Add BG is highlighted See Adding a BG Bolus to ezCarb edat page 62 in this chapter Food List Review Total Add BG Show Result NOTE The max limit for carb totals that are used in the bolus calculator is 999g The Actual field below the Carbs field will be set to Og grams This refers to carb amounts that are entered from the
195. r selected under CGM Setup menu options one time No progression 129 Emm 199 euooxeg 1 Always use Fingerstick BG for Treatment Decisions and CGM Calibration mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS Warning CGM Session Expires In 6 Hours Current CGM Session has 6 hours left until 7 day CGM Session Cause Expires In period ends 06 00 Insulin deliveries continue CGM continues CONFIE Displayed each time pump is awakened until confirmed Each time the pump is awakened Message the screen will display the actual time remaining rather than the original 6 hours displayed when the Warning first appeared Press to confirm Replace CGM Sensor in 6 hours and start new CGM session Beeps Vib Silent no Beeps Vib one time No progression Dexcom CGM Warning CGM Session Expires In 2 Hours Cause Current CGM Session has 2 hours left until 7 day CGM Session period ends Insulin deliveries continue CGM continues Canfirii Displayed each time pump is awakened until confirmed Each time the pump is awakened Message the screen will display the actual time remaining rather than the original 2 hours displayed when the Warning first appeared Press to confirm Replace CGM Sensor in 2 hours and start new CGM session Beeps Vib Silent no Beeps Vib one time No progression 130 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS mum War
196. rend screens until the calibration update recalibration was successful Your pump will then begin resume displaying CGM readings 117 m CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP mum Dexcom CGM 118 You can review certain historical records on your pump or you can use the Diasend Web based Diabetes Management System to track review and analyze pump CGM history on your computer Visit www diasend com animas for more information CGM Session Start History This selection displays the start date and time of your current CGM session NOTE CGM Session Start history is only available if a CGM session is currently active 1 From the Main Menu screen scroll to CGM and press Suspnd Resum History Basal Setup Prime Rewind Status Home BG Cal 2 Scroll to History and press Trend Graph Start Stop History Main Menu CGM History Session Start Last BG Cal Warnings 3 With Session Start highlighted on the CGM History screen press EE ami 1 The start date and time of your current CGM session will appear on the 12 17PM display Only your last current CGM Session Start record is available for Elapsed viewing To return to the CGM History screen highlight CGM History on any Od 4hr 11 Session Start record screen and press Remaining 6d 19h 49m CGM History 119 7 199 111 me CHAPTER 7 CGM HISTORY SCREENS
197. replace the battery If using the download feature keep the communication window free of obstructions and refer to the Instructions for Use included with the wireless download cable Visit www diasend com animas for information on the Diasend Web based Diabetes Management System that you can use to track review and analyze pump data on your computer You can also contact Customer Support or your local Animas distributor for information on Diasend Diabetes Management Software and wireless download cable 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 see page 187 Choose an area at least 7 6 centimeters 3 inches away from your infusion site or where you plan to inject insulin to insert the CGM Sensor Avoid skin sites with tattoos or areas with rough patches or scarring from your pump or insulin injections mmm BEFORE YOU BEGIN A PRECAUTIONS continued Your pump uses battery power to notify you of 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 Your pump is designed only for Continuous Subcutaneous Insulin Infusion CSII It is not intended for use with any other delivery substance Consu
198. rly CGM Sensor errors may resolve themselves and the CGM session will continue The CGM Sensor should be replaced if no CGM readings appear after recalibrating Follow the guidelines below to have the best result with your CGM Sensors POSSIBLE PROBLEMS SUGGESTED SOLUTION Expired damaged CGM Sensors or CGM Transmitter Sensor not attached secured properly Do Not use expired CGM Sensors Store CGM Sensors at room temperature See Chapter 1 in Section pages 141 144 for maintenance and storage of your CGM Sensors Make sure your CGM Transmitter is snapped in fully e Make sure your Sensor Pod is not dislodged or peeling up 156 Maintenance amp Technical Information D m CHAPTER 4 SICK DAY GUIDELINES During periods of minor 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 health care team if e Illness persists without improvement for 24 48 hours e Temperature rises above 37 8 Centigrade 100 Fahrenheit 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 3 3 mmol L or above 13 9 mmol L above 7 2 mmol L during pregnancy after taking extra bolus doses as prearranged by your health care team e You show signs of k
199. rm Rate 0 670 Prime Date and time basal rate was adjusted Suspend Basal rate adjustment 2 Scroll up to highlight the record field Press Q9 to activate Review Mode indicated by flashing cursor Record 1 indicates the most recent record Use the O O buttons to scroll to other records GB 4 When finished reviewing press to exit Review Mode 5 lt is highlighted Press to return to the HISTORY menu NOTE Basal 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 e Battery change e Suspend Alarm Basal segment set to 0 Basal edit screen accessed Prime menu accessed 055 of prime m CHAPTER 7 HISTORY FEATURE m Animas Vibe Insulin Pump LES ms CHAPTER 8 STATUS FEATURE This feature gives you easy access to a summary of information about your pump s current programming and performance There are seven Status screens 1 From the MAIN MENU or from the Home screen scroll to Status and press cies Bolus CGM Suspnd Resum Histor Basal Basal Rate Setup 0 025U Hr Prime Rewind Insulin 105U Status Screen 1 Active Basal STATUS 1 The screen displays the following information ACTIVE BASAL 3 A1 WEEKDAY e Whi
200. rmed the warning will re appear every 3 minutes Basal deliveries will stop until either the warning is confirmed or that time period is complete For the Exceeds Max TDD warning Basal deliveries will Combined basal and bolus delivery exceeds user set 2 hour maximum Insulin delivery stops Any Combo Bolus or Temp Basal is canceled Press to confirm Reprogram Max 2 Hr amount in the Setup Advanced menu User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour resume the following day beginning at midnight For the Exceeds Max 2 hour Delivery warning Basal deliveries will resume the next 2 hour time period Exceeds max TDD XXX U No delivery bolus amp active temp basal cancelled Confirm aqra GB Exceeds max 2 Hr XXX No delivery bolus amp active temp basal cancelled m CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Animas Vibe Insulin Pump Alerts Warnings and Alarms Warning Exceeds Max Basal Exceeds Basal delivery rate or Temp Basal delivery exceeds XXX BE Cause user set maximum No basal delivery Basal delivery stops Confirm Displayed when awakened by basal delivery attempt every 3 minutes or manually until confirmed Press to confirm Reprogram Max Basal amount in the Setup Advanced menu or reprogram Temp Basal Beeps
201. rstick BG tests and entering the values into your pump will not result in further CGM readings appearing on the display Any fingerstick BG values entered into your pump while the is displayed will be ignored 115 mw CHAPTER 6 VIEWING CGM INFORMATION ON YOUR PUMP Dexcom CGM Missing CGM Readings appears in place of current CGM reading 12 34 PM Example CGM Trend screen with missing data CGM Sensor Failure Insulin Delivery Continues Confirm CGM Session Stopped Any time your see the symbol on either the CGM Data or CGM Trend screens your pump did not understand a CGM reading that it received from your CGM Sensor Transmitter Check that your CGM Sensor is still sticking well to your skin and that nothing else is rubbing against the Sensor Pod such as clothing or seat belts Check that the CGM Transmitter is snapped in on both sides of the Sensor Pod NOTE may appear on CGM Data CGM Trend screens for several hours Call Customer Support or your local Animas distributor see page 187 for assistance if continues to appear for more than a few hours When you see instead of a CGM reading taking additional fingerstick BG tests and entering the values into your pump will not result in further CGM readings appearing on the display Any fingerstick BG values entered into your pump while the is displayed will be ignored Sometimes the problem will resolve itse
202. rt from center of lens and pull in all directions to remove moisture and bubbles from under the surface Pull squeegee across all corners and edges to adhere film 9 Remove excess moisture with lint free cloth e f necessary apply direct pressure to film edges until film is adhered to lens Your pump can be used immediately after film application e Wash hands thoroughly after film application IMPORTANT INFORMATION The viewing area of the pump display should be visually clear after film application If air or moisture bubbles are visible after the film is installed peel the film up from one edge at least to the location of the bubbles Re spray the film adhesive and the pump surface with solution and re apply the film with the squeegee If this does not remove the bubbles reinstall a new film Maintenance amp Technical Information D 146 3 CHAPTER 3 TROUBLESHOOTING GUIDELINES sm is a good idea to set a troubleshooting procedure to use anytime you suspect something might be wrong Work with your health care team to establish guidelines in the event of a problem Hypoglycemia WARNING Low BG is a risk for anyone using insulin therapy You may experience one or more of the following symptoms 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 confusio
203. ry life to be less than what is shown by the battery life indicator if you access pump features on a regular basis Be prepared to replace the battery whenever the battery icon shows that it is less than completely shaded full After a set amount of time with no button presses your pump display screen will time out to conserve battery life When your pump times out the screen display is blank 6 m CHAPTER 2 INTRODUCTION TO YOUR ANIMAS VIBE INSULIN PUMP mm Main Menu Screen This screen shows all Main Menu options CGM Suspnd Resum History Bolus Basal Setup This selection takes you to the Normal Bolus screen If you have activated Prime Rewind Advanced Bolus features the Bolus Menu will be displayed From the Bolus Menu you can select the bolus type program and deliver the bolus dose CGM This selection takes you to the CGM Menu screen where you can access all CGM functions available on your pump In addition you have the option to set BG limits alarms sound levels etc Suspend Resume This selection stops all insulin deliveries and Resume restarts basal delivery aqra GB History This selection allows you to review history of boluses total daily dose TDD alarms primes suspend and basal information Basal This selection allows you to access and program your basal rate This continuous rate maintains your BG between meals This rate will be determin
204. s Having more than one pre set basal program makes it easy for you to switch based on your needs including weekends weekdays shift work and menstruation If you are new to pumping your health care 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 9 in Section 1 pages 43 56 A CAUTION The lowest basal delivery amount possible is 0 025U Hr The highest basal delivery amount possible is 25U Hr or the Max Basal amount you set in the Setup Advanced menu in Chapter 11 in Section 1 This applies to any basal rate programmed in any basal program and to any adjusted basal rate you set with the Temporary Basal Feature see page 27 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 uinsu NOTE The buttons will move the cursor through fields when not in Edit mode When in Edit mode the buttons will change the value of the field If the cursor is flashing that means you can edit the entry Use the b
205. s must be removed Do Not bring pump or CGM Transmitter Sensor into the same room where the procedure is being performed X RAY DENTAL MS P e Teflon plastic infusion set can remain in Other types of infusion sets must be removed Do Not bring pump CGM Transmitter Sensor into the same room where the procedure is being performed X RAY MAMMOGRAM 5 Teflon plastic infusion set can remain in Other types of infusion sets must be removed zw BEFORE YOU BEGIN s PRECAUTIONS Your pump is a sealed device that should be opened ONLY by the manufacturer If your pump seal is broken by anyone other than an authorized Animas factory technician the warranty is voided and your pump is no longer waterproof If the back label on your pump is removed or damaged the warranty is voided and your pump is no longer waterproof When using your pump if the pump is placed at a vertically higher position than the infusion site a small amount of additional insulin infusion may occur To minimize this condition and maintain pump delivery accuracy the vertical distance between your pump and the infusion site should be no more than 30 centimeters 12 inches If your 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
206. s Owner s Booklet 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 Owner s Booklet handy for reference Any reference to CGM refers to the optional Dexcom CGM that is reviewed in Section Il You have begun a new way of life with your Animas Vibe System Your choice to begin pump therapy is a sign that you are committed to taking excellent care of yourself Your pump has been specially designed to help you manage your diabetes using sophisticated safety systems Your pump is used for insulin therapy to help maintain your blood glucose BG targets as recommended by your health care team You program it to deliver two ways 1 a continuous 24 hour basal rate and 2 bolus insulin deliveries to accommodate for immediate doses to cover foods eaten and high BG It is important to remember that successful pump therapy is a partnership of advanced technology and responsible self care Please take a moment to look at the back of your pump and write down the serial number My pump serial number is ANIMAS VIBE INSULIN PUMP UK ORDERS PUMP SUPPORT 0800 055 6606 IRELAND ORDERS SUPPORT West Chester 1800 812715 t 2011 01 IPX8 S N XX XXXXX 16 Label P N 400 508 05rA Made in o c c o c CN TA Technical Help If there is anything you do not understan
207. s applied to the suggested total bolus amount In this case your current BG is above your target range and your BG correction amount is greater than your IOB amount Therefore the insulin amount suggested is to cover the carbs being consumed and any BG correction amount not already covered by your IOB In Example 3 your current BG is below your target range resulting in a negative BG correction amount In this case your carb amount needs to be offset by your BG correction amount since you are already below your target range Therefore the insulin amount suggested is to cover only the carb amount not already covered by your IOB amount and the negative BG correction amount 64 mew CHAPTER 10 USING ADVANCED FEATURES mm ezBG This feature allows you to enter your current Actual BG value and your pump BOLUS MENU will automatically calculate a BG correction bolus based on your ISF and BG Target range for the current time stored in the pump If the IOB feature is activated your pump will subtract your IOB amount from the BG correction Combo Bolus amount before calculating and displaying the suggested bolus amount Reminders 1 From the BOLUS MENU select ezBG Press the amp button 2 The Actual field will be highlighted and flashing to indicate Edit mode Use the buttons to enter mmol L your actual BG value Press the button to confirm 12 4 the entry and exit Edit mode 5 8 5 8 2 1 mmol L 15 2
208. s to have a high BG level in the morning upon waking Basal rate delivery by the Animas Vibe Insulin Pump can be programmed to compensate for dawn phenomenon default pump setting that is selected automatically unless another option is chosen diabetes Diabetes is a complex disease in which the body cannot maintain healthy BG 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 The 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 emptying of the stomach resulting in unpredictable swings in BG levels 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 high BG levels If the body cannot produce enough insulin this can lead to hyperglycaemia and
209. screen in step 2 Reminders Combo Bolus Total Duration 0 5 2 Use the O O buttons to enter the Total bolus amount Press Go Normal Extend is highlighted The factory default setting for Duration is 30 minutes and the 0 100 Ratio is 096 Normal and 10096 Extended If these settings are appropriate 0 00 0 00U press Y to deliver Go Combo Bolus Total 8 50U 3 change either the Duration or Ratio scroll up to the desired field and Duration press to activate Edit mode Normal Extend 30 70 2 55 5 950 Go Combo Bolus Total 8 50U Duration 0 5 Normal Extend 30 700 4 Use the O O buttons to change settings As you change the Ratio by 2 55 5 95U percentage the amount in units is automatically changed You cannot change 60 the ratio by units only by percentage 5 When settings are correct press to confirm and exit Edit Mode NOTE Your pump 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 mew CHAPTER 10 USING ADVANCED FEATURES mm 6 Scroll to and press to activate The Home Combo Bolus 2 2 7 screen shows Combo Bolus Active Total 8 50U ED
210. second BG value NOTE Suspending insulin delivery during the 2 hour CGM Startup period will not affect the initial calibration sequence and the CGM session will remain active 12 hour CGM Calibration Update Your CGM requires that you perform a calibration update at least once every 12 hours with a fingerstick BG value that you enter in the pump Calibration update is necessary to make sure CGM Sensor readings remain accurate and are close to your BG meter readings Follow the steps under the preceding section 2 Hour CGM Startup Period Calibration for entering a BG value at any time Any fingerstick BG value you may have entered in your pump during ezCarb and ezBG Bolus calculations may serve as a BG value for the calibration update see Chapter 10 in Section pages 57 72 You only need to enter 1 fingerstick BG value for each 12 hour CGM calibration update If you forget to enter a BG value during each 12 hour period you will be CGM Warning prompted to enter one Press to confirm the Warning and follow the steps for entering a BG value The CGM Warning screen will re appear until you QNI Enter BG enter a new BG fingerstick value that is accepted for calibration 106 me CHAPTER 5 CGM CALIBRATION mu CGM Recalibration Warning When you enter a fingerstick BG value for calibration update the CGM checks how well it is functioning compared to BG meter results During each calibration update you
211. set can be used with your Animas Vibe Insulin Pump consult your health Animas Vibe Insulin Pump Never start the Prime Rewind sequence your pump while the infusion set is connected to your body Failure to disconnect your infusion set from your body before you start the Prime Rewind process can result in over delivery of insulin and possible injury or death If your pump sustains internal damage the amount of unintended insulin delivery could be significant This could result in serious injury or death from hypoglyczmia 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 Luer connector of infusion set from your pump using a counter clockwise motion 4 Remove infusion set tubing cap from the Luer connector Not all infusion sets have these caps Top of cartridge compartment cap 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 tip with hands or work surface Correctly threaded through cap m CHAPTER 3 GETTING YOUR PUMP READY 6 Remove cap from the filled cartridge tip To avoid insulin spillage
212. ska 29 Praha 1 POST 110 01 Czech Republic Toll free 420 800 100261 Tel 420 381 291280 Tech support 420 602 144 886 Email info aimport cz Web www aimport cz Denmark Rubin Medical AB Krossverksgatan 5M Box 30044 20061 LIMHAMN Sweden Tel 46 4015 5480 Fax 46 4015 5825 Email info rubinmedical se Web www rubinmedical se Finland Pharmanova Oy Teknobulevardi 3 5 01530 VANTAA Finland Tel 358 20 761 9670 Tech support 358 207 61979 Fax 358 207 619671 Email info pharmanova fi Web www pharmanova fi France Novalab France Rue Avaul e 14 92240 Malakoff France Tel 33 146 552 929 Fax 33 146 552 728 Email info novalab fr Web www novalab fr Germany Animas EMEA Division of Cilag GmbH International Landis Gyr Strasse 1 6300 Zug Switzerland Email Animas EMEA its jnj com Hungary Pharma Marketing Kft Boris u 4 1031 Budapest Hungary Tel 36 1242 2146 Fax 36 1242 2146 Email pharma marketing pharma marketing hu Web www pharma marketing hu Israel Tritech Biomed Hanagar Street 22 45240 Hod Hasharon Israel Tel 972 9760 1114 Toll free 972 1 800 353 566 Technical support 972 3744 1515 Fax 972 9748 2616 Email guy tritech co il Web www tritechbiomed co il Italy Movi S p A Via Dione Cassio 15 20138 Milano Italy Tel 4 39 02509051 Tech support 39 800 272 777 Fax 39 0
213. smitter into the Sensor Pod using the Transmitter Latch The same CGM Transmitter is used when you change CGM Sensors As the CGM Transmitter nears the end of its 6 month warranty it can sometimes lose communication with the pump This can happen even if the pump and CGM Sensor Transmitter are within 3 6 meters 12 feet of each other Once the CGM Transmitter battery has drained you will need to replace the CGM Transmitter because it can no longer communicate talk to the pump You can easily set up a new CGM Transmitter to talk with your pump see Chapter 2 in Section II pages 87 94 NOTE e Your CGM Transmitter is re used for many CGM Sensor uses e f you see in place of a CGM reading this means your CGM Sensor Transmitter and pump are not talking This can happen even when your pump and CGM Sensor Transmitter are within 3 6 meters 12 feet of each other The CGM Transmitter is designed and tested to withstand common electromagnetic interference including airport security systems To obtain information about bringing your CGM Transmitter through airport security check in contact the Federal Aviation Administration or your country equivalent or your local airport security office before traveling by air e Refer to Chapter 3 in Section Ill pages 147 156 to troubleshoot CGM Sensor failures and errors e Refer to Chapter 10 in Section Il page 137 for information the CGM Transmitter Low Battery Warning Dexcom CGM Be
214. so that the second digit is flashing 7 Repeat these steps until you have correctly entered all 5 numbers letters from your CGM Transmitter ID Serial Number Press when the last digit is highlighted 8 CGM Setup will be highlighted If you need to edit the ID Serial Number you just entered scroll to the ID Serial Number and re enter the correct ID Serial Number With CGM Setup highlighted press to return to the CGM Setup screen NOTE If this is the first time you are entering an ID Serial Number all zeros 00000 will appear in the S N field mw CHAPTER 2 CGM SETTINGS Setting CGM Alerts on your Pump You can set your pump to display and sound beep vibrate an alert when e Your CGM readings are outside your target range Your readings may be rising or falling too quickly e Your CGM Transmitter is not within RF range of your pump There are other CGM problems that require your attention On a few CGM settings you can also select a snooze time The snooze time tells your pump to display sound the alert again at a set amount of time after first confirming the alert if the condition causing the original alert has not been resolved Consult with your health care team on the settings that are most appropriate for you CGM settings affect how and when your pump displays sounds an alert and how information is displayed on the CGM Data and CGM Trend screens You can set pump sounds f
215. t 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 your pump may impact the battery contact and or the waterproof feature of your pump Call Customer Support or your local Animas distributor see page 187 if you identify or suspect your pump is damaged They will help determine if your pump should be replaced Disposal International regulations require controlled disposal of devices such as insulin pumps Contact Customer Support or your local Animas distributor see page 187 for disposal instructions Dispose of batteries according to your local environmental regulations Care and Maintenance of your Dexcom CGM The CGM Transmitter and Sensor require minimal maintenance Keep the following tips in mind CGM Sensor and Transmitter Insert the CGM Sensor only as directed e Snap the CGM Transmitter completely into the Sensor Pod in the correct alignment Calibrate the Sensor Transmitter every 12 hours as directed Do Not expose the CGM Sensor Transmitter to water deeper than 2 4 meters 8 feet and Do Not expose the CGM Sensor Transmitter to water for over 24 hours Remove the Sensor Transmitter as directed Keep the CGM Transmitter clean and protected when not in use 142 Maintenance amp Technical Information D mw CHAPTER 1 AND MAINTENANCE
216. tached to your body The most common problems are listed in the following table along with some suggested solutions POSSIBLE PROBLEMS SUGGESTED SOLUTION Safety Lock Transmitter Key will not Make sure to pull straight out using the arrows the detach from the Applicator Safety Lock Transmitter Key as a guide Do Not wiggle back and forth Applicator Collar will not pull up Make sure the Plunger is completely pressed down before pulling the Collar up e When pulling the Collar up you should hear 2 clicks e Try using more force when pulling the Collar up Applicator will not detach from the Pull the Collar all the way up It should be very close to Sensor Pod the top of the Applicator Make sure the Transmitter Latch is down before squeezing the Release Tabs Then squeeze the center part of the ribbed Release Tabs on the side of the Sensor Pod and lift the Applicator away from your body Transmitter Latch will not remove e Hold the Sensor Pod down with one hand and twist the easily Latch with the other hand to remove it e Do Not try to snap it straight off Sensor Pod does not remain stuck Do Not use any cream or lotion on your skin where you on body attach the Sensor Pod e Clean the skin with alcohol and make sure it is completely dry before you attach the Sensor Pod Do Not leave any substance on the skin where the Needle inserts You may use medical tape such as Blenderm
217. tattoos or rough patches of skin from your insulin injections or pump Avoid areas where you put pressure while sleeping Choose an area at least 7 6 centimeters 3 inches from where you plan to inject insulin or from where your pump infusion site is located Avoid using the same spot repeatedly for CGM Sensor insertion Never use the same site for two CGM Sensor uses in a row You may need to shave the area where you plan to put the CGM Sensor so that the adhesive patch sticks well Make sure there are no traces of lotions perfumes or medications on the area Clean the area first with an alcohol swab Make sure the area is clean and completely dry before you insert the CGM Sensor 3 Place the CGM Sensor After you have cleaned your skin use the adhesive tape tabs to remove the adhesive backing from the Sensor Pod one half at a time Hold the CGM Sensor by the plastic Applicator and try not to touch the sticky adhesive patch b Place the CGM Sensor on the chosen area of your belly You can place the CGM Sensor flat facing to the left or right of your belly button Make sure the CGM Sensor is placed in the same direction shown in the picture below You should not place the CGM Sensor pointing in the up or down direction Remove the Adhesive backing Adhere the CGM Sensor on the skin mew CHAPTER 3 INSERTING THE CGM SENSOR AND TRANSMITTER C After placing the CGM Sensor press firmly on and around the
218. te as it performs a self test SSPE 79755 5 When the rewind action is complete the REWIND COMPLETE screen is displayed Your pump will beep once to let you know the rewind is complete ACUE NOTE If using a partially filled cartridge you can select Stop during the Position Rewind Active function to stop the rewind at the position desired After every 160U third rewind your 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 rewind the piston rod lt lt lt lt lt lt lt lt mw CHAPTER 3 GETTING YOUR PUMP READY 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 A WARNING Never tighten the cartridge cap while the infusion set is connected to your body Failure to disconnect your infusion set from your body before performing this step can result in over delivery of insulin and possible injury or death If your pump sustains internal damage the amount of unintended insulin delivery could be significant This could result in serious injury or death from hypoglycaemia NOTE If screen display has timed out while loading your cartridge select B Rewind Prime Rewind from the MAIN MENU and highlight Load Cart from the ezPrime menu Press to display the REWIND COMPLETE
219. terial 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 an Animas representative is not available in your area contact your local Animas distributor see page 187 for warranty assistance 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 must 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 Vibe 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
220. th fingerstick test User selected under CGM Setup menu options Beeps Vib every 3 minutes until confirmed If confirmed snooze for user selected snooze time No progression Message Warning Glucose Level Below Low Glucose Alert Level Glucose Cause Last CGM reading at or below limit set in pump Level is Below Low Insulin deliveries continue CGM continues User Limit NE Dexcom CGM Displayed each time pump is awakened until confirmed Action Press to confirm Check BG with fingerstick test Message User selected under CGM Setup menu options Beeps Vib every 3 minutes until confirmed If confirmed snooze for user selected snooze time No progression 132 mw CHAPTER 10 CGM SAFETY SYSTEM AND ALERTS mum Warning Glucose Level Falling Faster Than Fall Rate Limit Glucose CGM readings are falling at or faster than Fall Rate Level is Cause limit set in pump Falling Too Quickly Insulin deliveries continue CGM continues Message Displayed each time pump is awakened until confirmed Action Press to confirm Check BG with fingerstick test User selected under CGM Setup menu options Beeps Vib every 3 minutes up to 3 times or until confirmed No progression Warning Glucose Level Rising Faster Than Rise Rate Limit Cause CGM readings are rising at or faster than Rise Rate limit set in pump Insulin deliveries continue CGM continues
221. the CGM Sensor and begin a new CGM session see Chapter 4 in Ended Section pages 103 104 Confirm Sensor Ending a CGM Session Before the 7 Day Expiration Time At any point during the CGM session you may also choose to end the session before its intended expiration time 1 From the MAIN MENU screen scroll to CGM and press History Basal Setup Prime Rewind CGM Menu BG Cal 2 Scroll to Start Stop and press Trend Graph Start Stop History Setup 123 uo xea 111 mw CHAPTER 8 COMPLETING A CGM SESSION Stop CGM Stop CGM sensor session Dexcom CGM 3 With STOP highlighted on the Stop CGM screen press CGM Alert z You will be notified on your pump display that you have stopped the CGM session Press to confirm the Warning After a few seconds you will return CGM Session to the CGM Menu screen Stopped by User Early CGM Sensor Expiration In some cases the CGM session may end before you have completed a full 7 day period See Chapter 10 in Section pages 127 140 for more information on the CGM Sensor Failure Warnings that may be displayed on your pump WARNING CGM Sensors may fracture on rare occasions If a CGM Sensor breaks and portion of it is visible above the skin Do Not attempt to remove it Seek professional medical help if you have symptoms of infection or inflammation redness swelling or pain at t
222. the cap which prevents water from entering the pump The battery cap also is equipped with a built in vent to allow air to enter your pump to maintain pressurization but prevent water from entering Be careful not to over tighten the battery cap See Chapter 3 in Section pages 9 20 Cartridge Cap Primary Vent Primary Vent This vent is part of the redundant vent safety system which allows air inside your pump to maintain equalized pressure but prevents water from getting inside Battery Cap Vent A WARNING Under no circumstances should you introduce any kind of sharp object into the vent openings Doing so will compromise your pump s waterproof capabilities If at any time you suspect the vent openings are clogged replace the battery cap Cartridge Compartment Cap This cap secures your cartridge and infusion set in your pump A WARNING 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 which can result in serious injury or death IR Window for Download The IR window is framed in blue This is the infrared communication window used for downloading your pump data c ANIMAS VIBE INSULIN PUMP UK ORDERS PUMP SUPPORT imas 0800 055 6606 Animas IRELAND ORDERS SUPPORT West Chester 1800 812
223. the problem is resolved RF communication will resume Refer to page 155 for more information on conditions that may cause RF communication problems mw BEFORE YOU BEGIN NOTE Any changes or modifications to the Animas Vibe System not expressly approved by Animas Corporation or Dexcom Inc could void the user s authority to operate the equipment mw BEFORE YOU BEGIN Animas Vibe System Kit Contents Your Animas Vibe System Kit includes your insulin pump and other accessories you will need to begin insulin delivery Check the contents of your kit to make sure all items are included If any items are missing call Customer Support or your local Animas distributor 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 see page 187 The CGM Sensor and Transmitter and supplies are packaged and provided separately Your Animas Vibe System Kit includes a Animas Vibe Insulin Pump b One Energizer Lithium Ultimate AA battery 1 5V for your pump c Low Profile Clip d Owner s Booklet e Quick Reference Guide f Orientation DVD not pictured mw BEFORE YOU BEGIN Explanation of symbols Shown below are symbols you will find on your Animas Vibe Insulin Pump and its packaging On your pump kit packaging 106 2 Do Not Reuse Pressure Limitations ur Fi 100 RH 4 Fragile 12 Relative Humidity L
224. til confirmed If not confirmed progresses to sweep vib within one hour Alarm Occlusion OCCLUSION DETECTED No delivery ance Continuous until confirmed aqra Press to confirm Disconnect and prime to clear occlusion Option to select Suspend see Suspend Warning screen page 77 User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour B i Once confirmed No Prime warning triggered see No Prime Warning screen page 80 mu CHAPTER 11 PUMP SAFETY SYSTEM AND ALARMS Alerts Warnings and Alarms Alarm Empty Cartridge Cartridge empty Da All insulin deliveries stop Continuous until confirmed EMPTY CARTRIDGE No delivery Replace cartridge Press to confirm Replace with full cartridge Option to select Suspend see Suspend Warning screen page 77 User selected every 3 minutes until confirmed If not confirmed progresses to sweep vib within one hour B i eps Once confirmed No Prime warning triggered see No Prime Warning screen page 80 Alarm Replace Battery REPLACE BATTERY Cause Battery life has a minimum of 3 minutes remaining No delivery All insulin deliveries stop Continuous until battery is removed or has no power Message y Animas Vibe Insulin Pump remaining J Action Remove battery to silence alarm Insert new
225. to calibrate your CGM with fingerstick BG test results at various times during a CGM session More specifically you will need to be prepared to take a fingerstick test s with your commercially available BG meter and enter the BG results into your pump within 5 minutes of being prompted The purpose of calibration is to correlate CGM Sensor readings to the reference BG meter to maintain CGM Sensor performance These are the required times for calibration e Startup Calibration at the end of the 2 hour CGM startup period Calibration Update at least once every 12 hours during a session Recalibration may be required if one of the fingerstick BG values entered for Startup Calibration or Calibration Update is not accepted by the pump WARNING You should update the CGM s calibration every 12 hours at a minimum The performance of the CGM when calibrated less frequently than every 12 hours has not been studied A PRECAUTION When entering fingerstick blood glucose values for CGM calibration you must enter the exact blood glucose value that your blood glucose meter displays Enter all fingerstick blood glucose values for CGM calibration within 5 minutes Entering incorrect fingerstick blood glucose values or fingerstick values that occurred more than 5 minutes ago will affect CGM performance W99 111 CONTRAINDICATION Use of acetaminophen containing medications while the CGM Sensor is inserted may affect
226. ts 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 safety lock transmitter key See CGM safety lock transmitter key sensor pod See CGM sensor pod sensor probe See CGM sensor probe startup period See CGM startup period 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 hyperglycaemia and ketoacidosis can result subcutaneous Subcutaneous means beneath the skin The infusion set needle is placed subcutaneously temporary or temp basal Setting a temporary basal lets you increase or decrease your current basal program rate for a desired period of time Your current basal rate is based on the basal program that is currently active in your pump When you set a temporary basal you select a percentage increase or decrease and then set the desired time period the increase or decrease will stay in effect transmitter See CGM transmitter transmitter ID See CGM transmitter ID transmitter key See CGM safety lock transmitter key transmitter latch See CGM transmitter latch trend arrow See CGM trend arrow 180 mw APPENDIX A G
227. ts iecit ets VII Empty cartridge 82 149 157 Ending a CGM 5 5 123 XII Establishing RF communication X 85 87 Exceeds max 2 hour 79 L Exceeds max basal warning 80 Exceeds max bolus 78 Language Setup isis tee tede 50 Exceeds max TDD 79 Laser SUTEN IV Exercise and 5 159 Lens protection 2 145 Extended see Combo bolus Lens protection film application 145 ezBolus cree trt pep bete ees 3 4 57 59 Locked ees 6 ezBG VII 48 53 59 65 Low battery warning insulin 78 ezCarb VII 48 53 59 60 62 Low battery warning CGM transmitter 137 Diasend Diabetes Management System VI 33 Low BG alert 91 110 132 59 85 119 Low BG alert insulin 75 Low blood glucose BG
228. ttery Alarm screen appearing sooner than expected GB m CHAPTER 3 GETTING YOUR PUMP READY mm Animas Vibe Insulin Pump 1 Changing the Battery Each time you change the battery e Always disconnect from infusion site prior to changing the battery e A full rewind and prime sequence is required See Priming your Pump and Infusion Set pages 16 18 in this chapter e The Insulin on Board IOB calculation starts over at zero 0 000 e The Combo bolus returns to the factory set default duration and split You should review your basal program settings WARNING Low Battery Warning means battery life will only last a minimum of 30 minutes You can remove the pump battery for up to 12 hours Once you re insert the battery the pump will prompt you to enter the time and date You must reset time and date The Replace Battery alarm will stop all CGM functions and no further CGM readings will be displayed until the battery is replaced see Section Il pages 85 140 1 Disconnect from infusion site 2 Use a coin to unscrew the battery cap with a counter clockwise motion 3 Check your battery cap for damage such as cracks or missing threads and be sure the colored o ring fits securely and is not torn or damaged O ring Battery Cap Vent Hole 4 Check the vent hole on the top of the battery cap to be sure it is clear of debris This vent maintains pressurization wh
229. tuations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 172 mw CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION mU Pump flow accuracy upon initial start up per IEC 60601 2 24 Average flow rate during a 30 minute period The measurements were taken at an intermediate basal rate of 2 0 U hr in accordance with 60601 2 24 1998 at room temperature 4 0 3 5 3 0 2 5 2 0 Flow rate U hr 1 5 1 0 Avg flow rate 30min Set rate 0 5 0 0 0 0 5 0 10 0 15 0 20 0 Time hr Pump flow accuracy after initial stabilization period per IEC 60601 2 24 The Trumpet curve shows the accuracy of the flow rate during a 5 hour period 300 deliveries as a function of an averaging window The reported percent error deviation is calculated from the overall weight increase over the full T time period 30 00 _ 20 00 amp 10 00 0 00 9 10 00 20 00 Ep max Ep min E cE 30 00 error 0 38 mor 40 00 10 30 50 70 90 Observation interval min The above pump flow test indicates that the insulin pump delivered with an accuracy of 0 38 173 uoneunuoJu je2Iuuoo D m CHAPTER 7 WARRANTY AND OTHER TECHNICAL INFORMATION Technical Specifications Dexcom CGM Sensor and Transmitter CGM Sensor 2 2 22 2 mmol L 40 400 mg dL Senso
230. ulin when calculating suggested bolus amounts insulin pump 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 BG tests daily to ensure delivery of appropriate amounts of insulin by the pump insulin sensitivity factor ISF Refers to how much you can lower your BG in mmol L with 1 unit of insulin Your ISF is one of several factors you use in calculating the amount of insulin you should deliver to cover for a high BG Your pump will use the ISF s you have programmed into your pump when calculating suggested bolus amounts insulin to carb 1 ratio Refers to how many carbs you can cover with 1 unit of insulin Your I C ratio is one of several factors you use in calculating the amount of insulin you should deliver to cover a carb amount Your pump will use the I C ratio s you have programmed into your pump when calculating suggested bolus amounts 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 or Luer connection is a standardized specially threaded fitting used to connect the
231. utomatically set to 0 mmol L Animas Vibe Insulin Pump For example if you set BG Target range of 4 5 6 1 mmol L midpoint is 5 3 mmol L and your current BG is 5 0 mmol L then the resulting difference is set to 0 mmol L If you set a single BG Target value then the difference between your current BG and your BG Target value is determined as follows e f your current BG is above your BG Target value the pump subtracts your BG Target value from your current BG For example if you set a BG Target value of 5 8 mmol L and your current BG is 6 1 mmol L then the resulting difference is 6 1 mmol L 5 8 mmol L 0 3 mmol L e f your current BG is below your BG Target value the pump subtracts your BG Target value from your current BG The resulting difference will be a negative number For example if you set a BG Target value of 5 9 mmol L and your current BG is 5 6 mmol L then the resulting difference is 5 6 mmol L 5 9 mmol L 0 3 mmol L f your current BG is exactly equal to your BG Target value then the resulting difference is automatically set to O mmol L For example if you set a BG Target value of 5 0 mmol L and your current BG is 5 0 mmol L then the resulting difference is set to mmol L m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION The SETUP ADV 1 BG Target screen allows you to set different BG Target ranges or values for 12 different time slots Each BG Target ran
232. utton to start stop Edit mode Use the My Information chart in Chapter 6 in Section Ill pages 161 164 to record and enter your basal program times and doses as recommended by your health care team 1 From the MAIN MENU select Basal Press Q9 Bolus Suspnd Resum History Setup The BASAL MENU displays the following Se iii Status Home Total basal insulin programmed for the 24 hour period Temp if you wish to program a Temporary Basal rate BASAL MENU BASAL MENU Total 0 00U Total 0 00U 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 A1 WEEKDAY ccr d programs in the Setup Advanced menu all 4 basal Fen keni program options will be displayed as shown on the 4 exercise far right m CHAPTER 5 USING BASAL PROGRAM FEATURES 2 Scroll to select the program 1 WEEKDAY and press Q9 BASAL MENU Total 0 00U NOTE You do not have to Suspend your pump to edit an active program Temp A1 WEEKDAY When you select Edit from the BASAL MENU your pump automatically suspends delivery When you exit the Edit mode the active program delivery automatically resumes 3 The BASAL OPTIONS screen is displayed Edit is highlighted Press the button From the EDIT BASAL screen you can edit the basal segments of the selected program EDIT BASAL Total 0 00U Start Scroll to the desired U Hr
233. vered e Status of bolus o ACTIVE o COMPLETED o CANCELED e f ezBG or ezCarb was used 2 To view other Bolus records first scroll up to highlight the record field Press to activate Review mode indicated by flashing cursor m CHAPTER 7 HISTORY FEATURE Animas Vibe Insulin Pump Record 1 indicates the most recent record Use the O O buttons to scroll to other records 4 When finished reviewing press to exit Review Mode 5 lt is highlighted Press to return to the HISTORY menu Total Daily Dose TDD History Your pump displays the last 120 TDD records 1 From the HISTORY menu select Total Daily Dose HISTORY TDD Record Total Daily 23 Mar 2010 i i T Dose TDD Temp No This screen displays the following Suspend No Bolus 6 200U e Record number Basal 0 700U TOTAL 6 900U Date of record f Temp Basal was active on that date e f Suspend was activated on that date Total Bolus for the date Total Basal for the date Total dose for the date NOTE Each daily total is the total delivered since midnight 2 Scroll up to highlight the record field Press Q9 to activate Review Mode indicated by flashing cursor Record 1 indicates the most recent record Use the O O buttons to scroll to other records 4 When finished reviewing press to exit Review Mode 5 is highlighted Press to return to the HISTORY menu mw CHAPTER 7 HISTORY FEATU
234. will gradually diminish over the 2 hour startup period See Chapter 6 in Section Il pages 109 118 for more information on the CGM Trend screen Dexcom CGM If the symbol appears on the CGM Data or Trend screen and or if your pump displays the Transmitter Out of Range Warning screen then your devices are not communicating Press to confirm the warning Transmitter Out of Range To troubleshoot CGM communication e Check that your pump and the CGM Sensor Transmitter within 3 6 meters 12 feet of each other If not move them closer Wait about 5 10 minutes to see if the shaded box appears on the CGM Data or Trend screen ANT will disappear The pump and CGM Sensor Transmitter may lose communication when they are near other metallic objects or while you are lying on a waterbed or using an electric blanket e f the Warning screen appears again verify that you have entered the correct CGM Transmitter ID Serial Number into your pump Refer to Chapter 3 in Section Ill pages 147 156 for troubleshooting problems with CGM communication If the correct ID number has been entered and the Warning screen continues to re appear contact Customer Support or your local Animas distributor 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 see page 187 104 In order for your CGM to work properly you will be prompted
235. y do not represent the actual calculation performed on the pump If the IOB feature is activated your IOB amount will always be displayed for reference but may not always be applied to the suggested total bolus amount Refer to Chapter 10 in Section 1 page 64 for an example of ezCarb when the IOB feature on your pump is activated IOB when using the ezBG feature The ezBG Total screen will display a BG correction amount your amount if the feature is activated and a suggested total bolus amount NOTE The displayed BG correction and IOB amounts and the resulting total bolus amount are for reference only They do not represent the actual calculation performed on the pump If the feature is activated your IOB amount will always be displayed for reference but may not always be applied to the suggested total bolus amount For instance when IOB is enough to cover the amount required to bring a high BG back into target range no additional insulin amount will be suggested to cover the high BG Refer to Chapter 10 in Section page 67 for an example of ezBG when the feature on your pump is activated m CHAPTER 9 ADVANCED FEATURES SETUP AND ACTIVATION mm WARNING The feature is intended for use only with U100 rapid acting insulin analogs such as Novo Rapid NovoLog Humalog or Apidra If you use an insulin other than Novo Rapid Novolog HumaLog or Apidra Do Not use this feature Us
236. ys Enter all fingerstick blood glucose values for CGM calibration within 5 minutes Entering incorrect fingerstick blood glucose values or fingerstick values that occurred more than 5 minutes ago will affect CGM performance All mentions of screen displays menus buttons etc in Section Il refer to the Animas Vibe Insulin Pump unless specifically stated otherwise About Radio Frequency RF Communication Your pump has built in RF capability RF is a type of wireless communication Cell phones use RF technology as do many other devices RF is how your pump and CGM communicate and share CGM data The RF feature on your pump will be deactivated when you first receive it In order to begin using your pump and CGM together as a system you must enter the ID number of your CGM Transmitter into your pump RF communication between your pump and CGM will work up to a distance of about 3 6 meters 12 feet and will transmit through clothing Direct line of sight is not required for RF communication As long as you have a good RF signal and are within range you can use your pump to display CGM data Exposing your pump and CGM to water and certain objects in between the two devices may interfere with RF communication When conditions or distance cause RF communication to be lost or interrupted you will not be able to use your pump to display CGM data This also means that data transfer between the two devices will stop temporarily As soon as

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